• Medical - Instruments & Supplies
  • Healthcare
Teleflex Incorporated logo
Teleflex Incorporated
TFX · US · NYSE
222.59
USD
+0.8
(0.36%)
Executives
Name Title Pay
Mr. James Ferguson President & GM of Surgical --
Mr. Timothy F. Duffy Vice President & Chief Information Officer --
Mr. Liam J. Kelly Chairman, President & Chief Executive Officer 2.63M
Mr. Thomas E. Powell BS, MBA Executive Vice President & Chief Financial Officer 1.29M
Mr. Howard Cyr Corporate Vice President & Chief Compliance Officer --
Mr. Daniel V. Logue Corporate Vice President, General Counsel & Secretary 720K
Mr. Cameron P. Hicks Corporate Vice President & Chief Human Resources Officer 565K
Mr. Jay White Corporate Vice President & President of Global Commercial 1.09M
Mr. John R. Deren Corporate Vice President & Chief Accounting Officer --
Ms. Michelle Fox Corporate Vice President & Chief Medical Officer --
Insider Transactions
Date Name Title Acquisition Or Disposition Stock / Options # of Shares Price
2024-02-27 Winters James Corp VP, Mfg and Supply A - A-Award Common Stock 1126 0
2024-02-27 White Jay CVP & Pres, Global Commercial A - A-Award Common Stock 1371 0
2024-02-27 POWELL THOMAS E Executive Vice President & CFO A - A-Award Common Stock 2398 0
2024-02-27 Logue Daniel V. CVP, General Counsel & Secty A - A-Award Common Stock 1331 0
2024-02-27 Kelly Liam Chairman, President & CEO A - A-Award Common Stock 6858 0
2024-02-27 Hicks Cameron P Corp. VP & Chief HR Officer A - A-Award Common Stock 998 0
2024-02-27 Deren John Corp. VP & CAO A - A-Award Common Stock 422 0
2024-06-18 Winters James Corp VP, Mfg and Supply A - A-Award Common Stock 243 0
2024-06-18 Winters James Corp VP, Mfg and Supply A - A-Award Stock Option / (Right to Buy) 1676 202.09
2024-05-07 HAGGERTY GRETCHEN R director A - A-Award Common Stock 649 0
2024-05-07 HAGGERTY GRETCHEN R director A - A-Award Stock Option / (Right to Buy) 1349 201.52
2024-05-07 Krakauer Andrew A director A - A-Award Common Stock 649 0
2024-05-07 Krakauer Andrew A director A - A-Award Stock Option / (Right to Buy) 1349 201.52
2024-05-07 RANDLE STUART A director A - A-Award Common Stock 649 0
2024-05-07 RANDLE STUART A director A - A-Award Stock Option / (Right to Buy) 1349 201.52
2024-05-07 Klasko Stephen K. M.D. director A - A-Award Common Stock 838 0
2024-05-07 Klasko Stephen K. M.D. director A - A-Award Stock Option / (Right to Buy) 1349 201.52
2024-05-07 Duncan Candace H director A - A-Award Common Stock 649 0
2024-05-07 Duncan Candace H director A - A-Award Stock Option / (Right to Buy) 1349 201.52
2024-05-07 HEINMILLER JOHN C director A - A-Award Common Stock 649 0
2024-05-07 HEINMILLER JOHN C director A - A-Award Stock Option / (Right to Buy) 1349 201.52
2024-05-07 Patil Neena M director A - A-Award Common Stock 649 0
2024-05-07 Patil Neena M director A - A-Award Stock Option / (Right to Buy) 1349 201.52
2024-05-07 Ryu Jaewon director A - A-Award Stock Option / (Right to Buy) 1349 201.52
2024-05-07 Ryu Jaewon director A - A-Award Common Stock 649 0
2024-03-02 Deren John Corp. VP & CAO D - F-InKind Common Stock 137 223
2024-03-05 Hicks Cameron P Corp. VP & Chief HR Officer A - M-Exempt Common Stock 4400 144.79
2024-03-05 Hicks Cameron P Corp. VP & Chief HR Officer A - M-Exempt Common Stock 3001 121
2024-03-02 Hicks Cameron P Corp. VP & Chief HR Officer D - F-InKind Common Stock 216 225
2024-03-05 Hicks Cameron P Corp. VP & Chief HR Officer D - S-Sale Common Stock 7401 225
2024-03-05 Hicks Cameron P Corp. VP & Chief HR Officer D - M-Exempt Stock Option / (Right to Buy) 4400 144.79
2024-03-05 Hicks Cameron P Corp. VP & Chief HR Officer D - M-Exempt Stock Option / (Right to Buy) 3001 121
2024-03-02 Kelly Liam Chairman, President & CEO D - F-InKind Common Stock 1840 223
2024-03-02 Logue Daniel V. CVP, General Counsel & Secty D - F-InKind Common Stock 149 223
2024-03-02 POWELL THOMAS E Executive Vice President & CFO D - F-InKind Common Stock 810 223
2024-03-02 White Jay CVP & Pres, Global Commercial D - F-InKind Common Stock 239 223
2024-03-02 Winters James Corp VP, Mfg and Supply D - F-InKind Common Stock 305 223
2024-02-27 Hicks Cameron P Corp. VP & Chief HR Officer A - A-Award Common Stock 988 0
2024-02-27 Hicks Cameron P Corp. VP & Chief HR Officer A - A-Award Stock Option / (Right to Buy) 6999 226.04
2024-02-27 Kelly Liam Chairman, President & CEO A - A-Award Stock Option / (Right to Buy) 48094 226.04
2024-02-27 Kelly Liam Chairman, President & CEO A - A-Award Common Stock 6787 0
2024-02-27 Winters James Corp VP, Mfg and Supply A - A-Award Stock Option / (Right to Buy) 7896 226.04
2024-02-27 Winters James Corp VP, Mfg and Supply A - A-Award Common Stock 1114 0
2024-02-27 White Jay CVP & Pres, Global Commercial A - A-Award Stock Option / (Right to Buy) 9612 226.04
2024-02-27 White Jay CVP & Pres, Global Commercial A - A-Award Common Stock 1356 0
2024-02-27 POWELL THOMAS E Executive Vice President & CFO A - A-Award Common Stock 2373 0
2024-02-27 POWELL THOMAS E Executive Vice President & CFO A - A-Award Stock Option / (Right to Buy) 16821 226.04
2024-02-27 Logue Daniel V. CVP, General Counsel & Secty A - A-Award Common Stock 1317 0
2024-02-26 Logue Daniel V. CVP, General Counsel & Secty A - M-Exempt Common Stock 1525 101.12
2024-02-26 Logue Daniel V. CVP, General Counsel & Secty D - F-InKind Common Stock 752 228.5
2024-02-27 Logue Daniel V. CVP, General Counsel & Secty A - A-Award Stock Option / (Right to Buy) 9332 226.04
2024-02-26 Logue Daniel V. CVP, General Counsel & Secty D - M-Exempt Stock Option / (Right to Buy) 1525 101.12
2024-02-27 Deren John Corp. VP & CAO A - A-Award Stock Option / (Right to Buy) 2957 226.04
2024-02-27 Deren John Corp. VP & CAO A - A-Award Common Stock 417 0
2024-02-19 Kelly Liam Chairman, President & CEO A - A-Award Common Stock 1856 0
2023-02-28 Kelly Liam Chairman, President & CEO A - A-Award Common Stock 6733 0
2024-02-19 White Jay CVP & Pres, Global Commercial A - A-Award Common Stock 251 0
2024-02-19 Logue Daniel V. CVP, General Counsel & Secty A - A-Award Common Stock 162 0
2024-02-19 Winters James Corp VP, Mfg and Supply A - A-Award Common Stock 194 0
2024-02-19 Deren John Corp. VP & CAO A - A-Award Common Stock 113 0
2024-02-19 POWELL THOMAS E Executive Vice President & CFO A - A-Award Common Stock 668 0
2024-02-19 Hicks Cameron P Corp. VP & Chief HR Officer A - A-Award Common Stock 232 0
2023-12-27 Kelly Liam Chairman, President & CEO A - M-Exempt Common Stock 3081 107.47
2023-12-27 Kelly Liam Chairman, President & CEO A - M-Exempt Common Stock 23175 101.12
2023-12-27 Kelly Liam Chairman, President & CEO D - S-Sale Common Stock 23585 250.124
2023-12-27 Kelly Liam Chairman, President & CEO D - S-Sale Common Stock 2671 251.16
2023-12-27 Kelly Liam Chairman, President & CEO D - M-Exempt Stock Option / (Right to Buy) 23175 101.12
2023-12-27 Kelly Liam Chairman, President & CEO D - M-Exempt Stock Option / (Right to Buy) 3081 107.47
2023-12-21 Kelly Liam Chairman, President & CEO A - G-Gift Common Stock 5785.653 0
2023-12-21 Kelly Liam Chairman, President & CEO D - G-Gift Common Stock 5785.653 0
2023-12-13 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 3021 101.12
2023-12-13 Klasko Stephen K. M.D. director D - F-InKind Common Stock 1296 235.89
2023-12-13 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 3021 101.12
2023-11-29 POWELL THOMAS E Executive Vice President & CFO A - M-Exempt Common Stock 4613 123.04
2023-11-29 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 1866 221.5
2023-11-29 POWELL THOMAS E Executive Vice President & CFO A - M-Exempt Common Stock 9339 121
2023-11-29 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 4629 222.41
2023-11-29 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 5796 223.35
2023-11-29 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 1661 224.13
2023-11-29 POWELL THOMAS E Executive Vice President & CFO D - M-Exempt Stock Option / (Right to Buy) 9339 121
2023-11-29 POWELL THOMAS E Executive Vice President & CFO D - M-Exempt Stock Option / (Right to Buy) 4613 123.04
2023-08-09 Kelly Liam Chairman, President & CEO D - G-Gift Common Stock 5768 0
2023-08-09 Kelly Liam Chairman, President & CEO A - G-Gift Common Stock 5768 0
2023-05-09 Ryu Jaewon director A - A-Award Stock Option / (Right to Buy) 2152 251.99
2023-05-09 Ryu Jaewon director A - A-Award Common Stock 527 0
2023-05-10 RANDLE STUART A director A - M-Exempt Common Stock 3021 101.12
2023-05-09 RANDLE STUART A director A - A-Award Common Stock 527 0
2023-05-10 RANDLE STUART A director D - S-Sale Common Stock 3021 245.71
2023-05-09 RANDLE STUART A director A - A-Award Stock Option / (Right to Buy) 1076 251.99
2023-05-10 RANDLE STUART A director D - M-Exempt Stock Option / (Right to Buy) 3021 101.12
2023-05-09 Patil Neena M director A - A-Award Stock Option / (Right to Buy) 1076 251.99
2023-05-09 Patil Neena M director A - A-Award Common Stock 527 0
2023-05-09 Krakauer Andrew A director A - A-Award Common Stock 527 0
2023-05-09 Krakauer Andrew A director A - A-Award Stock Option / (Right to Buy) 1076 251.99
2023-05-09 Klasko Stephen K. M.D. director A - A-Award Common Stock 681 0
2023-05-09 Klasko Stephen K. M.D. director A - A-Award Stock Option / (Right to Buy) 1076 251.99
2023-05-09 HEINMILLER JOHN C director A - A-Award Common Stock 527 0
2023-05-09 HEINMILLER JOHN C director A - A-Award Stock Option / (Right to Buy) 1076 251.99
2023-05-09 HAGGERTY GRETCHEN R director A - A-Award Common Stock 527 0
2023-05-09 HAGGERTY GRETCHEN R director A - A-Award Stock Option / (Right to Buy) 1076 251.99
2023-05-09 Duncan Candace H director A - A-Award Common Stock 527 0
2023-05-09 Duncan Candace H director A - A-Award Stock Option / (Right to Buy) 1076 251.99
2023-05-05 Ryu Jaewon - 0 0
2023-02-28 Winters James Corp VP, Mfg and Supply A - A-Award Stock Option / (Right to Buy) 6350 238.23
2023-02-28 Winters James Corp VP, Mfg and Supply A - A-Award Common Stock 912 0
2023-02-25 Winters James Corp VP, Mfg and Supply D - F-InKind Common Stock 173 235.18
2023-02-28 White Jay CVP & Pres, Global Commercial A - A-Award Stock Option / (Right to Buy) 9381 238.23
2023-02-28 White Jay CVP & Pres, Global Commercial A - A-Award Common Stock 1347 0
2023-02-25 White Jay CVP & Pres, Global Commercial D - F-InKind Common Stock 135 235.18
2023-02-28 POWELL THOMAS E Executive Vice President & CFO A - A-Award Stock Option / (Right to Buy) 16416 238.23
2023-02-28 POWELL THOMAS E Executive Vice President & CFO A - A-Award Common Stock 2357 0
2023-02-25 POWELL THOMAS E Executive Vice President & CFO D - F-InKind Common Stock 542 235.18
2023-02-28 Logue Daniel V. CVP, General Counsel & Secty A - A-Award Common Stock 1139 0
2023-02-25 Logue Daniel V. CVP, General Counsel & Secty D - F-InKind Common Stock 40 235.18
2023-02-28 Logue Daniel V. CVP, General Counsel & Secty A - A-Award Stock Option / (Right to Buy) 7938 238.23
2023-02-28 Kelly Liam Chairman, President & CEO A - A-Award Stock Option / (Right to Buy) 46904 238.23
2023-02-28 Kelly Liam Chairman, President & CEO A - A-Award Common Stock 5050 0
2023-02-25 Kelly Liam Chairman, President & CEO D - F-InKind Common Stock 1025 235.18
2023-02-28 Hicks Cameron P Corp. VP & Chief HR Officer A - A-Award Common Stock 906 0
2023-02-25 Hicks Cameron P Corp. VP & Chief HR Officer D - F-InKind Common Stock 134 235.18
2023-02-28 Hicks Cameron P Corp. VP & Chief HR Officer A - A-Award Stock Option / (Right to Buy) 6314 238.23
2023-02-28 Deren John Corp. VP & CAO A - A-Award Stock Option / (Right to Buy) 2886 238.23
2023-02-28 Deren John Corp. VP & CAO A - A-Award Common Stock 414 0
2023-02-25 Deren John Corp. VP & CAO D - F-InKind Common Stock 88 235.18
2022-12-31 Kelly Liam Chairman, President & CEO I - Common Stock 0 0
2023-01-27 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 3014 78.5
2023-01-27 Klasko Stephen K. M.D. director D - F-InKind Common Stock 967 244.68
2023-01-27 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 3014 0
2023-01-11 Kelly Liam Chairman, President & CEO A - M-Exempt Common Stock 3579 82.26
2023-01-11 Kelly Liam Chairman, President & CEO A - M-Exempt Common Stock 6040 78.62
2023-01-11 Kelly Liam Chairman, President & CEO D - F-InKind Common Stock 2173 259.48
2023-01-11 Kelly Liam Chairman, President & CEO D - F-InKind Common Stock 3064 259.48
2023-01-11 Kelly Liam Chairman, President & CEO A - M-Exempt Stock Option / (Right to Buy) 6040 0
2023-01-11 Kelly Liam Chairman, President & CEO A - M-Exempt Common Stock 6040 78.62
2023-01-11 Kelly Liam Chairman, President & CEO A - M-Exempt Common Stock 3579 82.26
2023-01-11 Kelly Liam Chairman, President & CEO D - F-InKind Common Stock 2173 259.48
2023-01-11 Kelly Liam Chairman, President & CEO D - F-InKind Common Stock 3622 259.48
2023-01-11 Kelly Liam Chairman, President & CEO A - M-Exempt Stock Option / (Right to Buy) 6040 0
2022-12-30 Kelly Liam Chairman, President & CEO A - M-Exempt Common Stock 16343 78.62
2022-12-30 Kelly Liam Chairman, President & CEO D - S-Sale Common Stock 16340 250.03
2022-12-30 Kelly Liam Chairman, President & CEO D - S-Sale Common Stock 3 251
2022-12-30 Kelly Liam Chairman, President & CEO D - M-Exempt Stock Option / (Right to Buy) 16343 0
2022-06-07 RANDLE STUART A A - M-Exempt Common Stock 3014 78.5
2022-06-07 RANDLE STUART A D - S-Sale Common Stock 3014 283.31
2022-06-07 RANDLE STUART A director D - M-Exempt Stock Option / (Right to Buy) 3014 78.5
2022-05-03 Patil Neena M A - A-Award Stock Option / (Right to Buy) 1937 0
2022-05-03 RANDLE STUART A director A - A-Award Common Stock 399 0
2022-05-03 RANDLE STUART A A - A-Award Stock Option / (Right to Buy) 969 0
2022-05-03 RANDLE STUART A director A - A-Award Stock Option / (Right to Buy) 969 284.85
2022-05-03 HEINMILLER JOHN C director A - A-Award Common Stock 399 0
2022-05-03 HEINMILLER JOHN C director A - A-Award Stock Option / (Right to Buy) 969 284.85
2022-05-03 HEINMILLER JOHN C A - A-Award Stock Option / (Right to Buy) 969 0
2022-04-29 Patil Neena M - 0 0
2022-05-03 Klasko Stephen K. M.D. A - A-Award Common Stock 399 0
2022-05-03 Krakauer Andrew A A - A-Award Common Stock 399 0
2022-05-03 HAGGERTY GRETCHEN R A - A-Award Common Stock 399 0
2022-05-03 Duncan Candace H A - A-Award Stock Option / (Right to Buy) 969 0
2022-05-03 BABICH GEORGE JR director A - A-Award Common Stock 520 0
2022-05-03 BABICH GEORGE JR director A - A-Award Stock Option / (Right to Buy) 969 284.85
2022-05-03 BABICH GEORGE JR A - A-Award Stock Option / (Right to Buy) 969 0
2022-03-01 White Jay VP & Pres, Global Commercial A - A-Award Stock Option / (Right to Buy) 8138 333.24
2022-03-01 White Jay VP & Pres, Global Commercial A - A-Award Common Stock 993 0
2022-02-28 White Jay VP & Pres, Global Commercial A - A-Award Common Stock 4 0
2022-02-28 White Jay VP & Pres, Global Commercial D - F-InKind Common Stock 132 343.01
2022-03-01 Kelly Liam Chairman, President & CEO A - A-Award Stock Option / (Right to Buy) 39063 333.24
2022-03-01 Kelly Liam Chairman, President & CEO A - A-Award Common Stock 4766 0
2022-02-28 Kelly Liam Chairman, President & CEO A - A-Award Common Stock 33 0
2022-02-28 Kelly Liam Chairman, President & CEO D - F-InKind Common Stock 1244 343.01
2022-03-01 Hicks Cameron P Corp. VP & Chief HR Officer A - A-Award Common Stock 600 0
2022-02-28 Hicks Cameron P Corp. VP & Chief HR Officer A - A-Award Common Stock 5 0
2022-02-28 Hicks Cameron P Corp. VP & Chief HR Officer D - F-InKind Common Stock 171 343.01
2022-03-01 Hicks Cameron P Corp. VP & Chief HR Officer A - A-Award Stock Option / (Right to Buy) 4915 333.24
2022-03-01 Logue Daniel V. CVP, General Counsel & Secty A - A-Award Common Stock 556 0
2022-02-28 Logue Daniel V. CVP, General Counsel & Secty A - A-Award Common Stock 2 0
2022-02-28 Logue Daniel V. CVP, General Counsel & Secty D - F-InKind Common Stock 59 343.01
2022-03-01 Logue Daniel V. CVP, General Counsel & Secty A - A-Award Stock Option / (Right to Buy) 4557 333.24
2022-03-01 POWELL THOMAS E Executive Vice President & CFO A - A-Award Stock Option / (Right to Buy) 14160 333.24
2022-03-01 POWELL THOMAS E Executive Vice President & CFO A - A-Award Common Stock 1728 0
2022-02-28 POWELL THOMAS E Executive Vice President & CFO A - A-Award Common Stock 16 0
2022-02-28 POWELL THOMAS E Executive Vice President & CFO D - F-InKind Common Stock 728 343.01
2022-03-01 Deren John Corp. VP & CAO A - A-Award Stock Option / (Right to Buy) 2441 333.24
2022-03-01 Deren John Corp. VP & CAO A - A-Award Common Stock 298 0
2022-02-28 Deren John Corp. VP & CAO A - A-Award Common Stock 3 0
2022-02-28 Deren John Corp. VP & CAO D - F-InKind Common Stock 121 343.01
2022-03-01 Winters James Corp VP, Mfg and Supply A - A-Award Stock Option / (Right to Buy) 5208 333.24
2022-03-01 Winters James Corp VP, Mfg and Supply A - A-Award Common Stock 635 0
2022-02-28 Winters James Corp VP, Mfg and Supply D - F-InKind Common Stock 223 343.01
2021-12-31 Hicks Cameron P Corp. VP & Chief HR Officer I - Common Stock 0 0
2021-12-31 HEINMILLER JOHN C director I - Common Stock 0 0
2021-12-27 Kelly Liam Chairman, President & CEO A - M-Exempt Common Stock 6711 59.96
2021-12-27 Kelly Liam Chairman, President & CEO A - M-Exempt Common Stock 2276 59.75
2021-12-27 Kelly Liam Chairman, President & CEO D - S-Sale Common Stock 8987 330
2021-12-27 Kelly Liam Chairman, President & CEO D - M-Exempt Stock Option / (Right to Buy) 2276 59.75
2021-12-27 Kelly Liam Chairman, President & CEO D - M-Exempt Stock Option / (Right to Buy) 6711 59.96
2021-11-30 Krakauer Andrew A director A - P-Purchase Common Stock 500 307.4643
2021-11-30 Krakauer Andrew A director A - P-Purchase Common Stock 500 307
2021-11-10 Hicks Cameron P Corp. VP & Chief HR Officer A - M-Exempt Common Stock 3600 121
2021-11-10 Hicks Cameron P Corp. VP & Chief HR Officer D - S-Sale Common Stock 3600 350
2021-11-10 Hicks Cameron P Corp. VP & Chief HR Officer D - M-Exempt Stock Option / (Right to Buy) 3600 121
2021-08-24 Deren John Corp. VP & CAO A - A-Award Common Stock 45 0
2021-08-24 Deren John Corp. VP & CAO A - A-Award Stock Option / (Right to Buy) 325 386.17
2021-08-18 Kelly Liam Chairman, President & CEO A - M-Exempt Common Stock 8987 59.75
2021-08-18 Kelly Liam Chairman, President & CEO D - S-Sale Common Stock 1007 374.85
2021-08-18 Kelly Liam Chairman, President & CEO D - S-Sale Common Stock 4045 375.32
2021-08-18 Kelly Liam Chairman, President & CEO D - S-Sale Common Stock 1051 376.43
2021-08-18 Kelly Liam Chairman, President & CEO D - S-Sale Common Stock 1513 377.53
2021-08-18 Kelly Liam Chairman, President & CEO D - S-Sale Common Stock 1371 378.92
2021-08-18 Kelly Liam Chairman, President & CEO D - M-Exempt Stock Option / (Right to Buy) 8987 59.75
2021-07-12 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 3564 59.75
2021-07-12 Klasko Stephen K. M.D. director D - S-Sale Common Stock 2214 422
2021-07-12 Klasko Stephen K. M.D. director D - S-Sale Common Stock 1200 423.39
2021-07-12 Klasko Stephen K. M.D. director D - S-Sale Common Stock 150 423.95
2021-07-12 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 3564 59.75
2021-06-10 Hicks Cameron P Corp. VP & Chief HR Officer A - M-Exempt Common Stock 1800 121
2021-06-10 Hicks Cameron P Corp. VP & Chief HR Officer D - S-Sale Common Stock 1671 395.05
2021-06-10 Hicks Cameron P Corp. VP & Chief HR Officer A - M-Exempt Common Stock 1676 101.12
2021-06-10 Hicks Cameron P Corp. VP & Chief HR Officer D - S-Sale Common Stock 1205 396.3
2021-06-10 Hicks Cameron P Corp. VP & Chief HR Officer D - S-Sale Common Stock 600 397.21
2021-06-10 Hicks Cameron P Corp. VP & Chief HR Officer D - M-Exempt Stock Option / (Right to Buy) 1800 121
2021-06-10 Hicks Cameron P Corp. VP & Chief HR Officer D - M-Exempt Stock Option / (Right to Buy) 1676 101.12
2021-06-04 RANDLE STUART A director A - M-Exempt Common Stock 3564 59.75
2021-06-04 RANDLE STUART A director D - F-InKind Common Stock 179 395.8
2021-06-04 RANDLE STUART A director D - S-Sale Common Stock 2384 395.66
2021-06-04 RANDLE STUART A director D - G-Gift Common Stock 278 395.8
2021-06-04 RANDLE STUART A director D - M-Exempt Stock Option / (Right to Buy) 3564 59.75
2021-05-04 RANDLE STUART A director A - A-Award Common Stock 300 0
2021-05-04 RANDLE STUART A director A - A-Award Stock Option / (Right to Buy) 771 412.68
2021-05-04 BABICH GEORGE JR director A - A-Award Common Stock 395 0
2021-05-04 BABICH GEORGE JR director A - A-Award Stock Option / (Right to Buy) 771 412.68
2021-05-04 Krakauer Andrew A director A - A-Award Common Stock 300 0
2021-05-04 Krakauer Andrew A director A - A-Award Stock Option / (Right to Buy) 771 412.68
2021-05-04 PACKER RICHARD A director A - A-Award Common Stock 300 0
2021-05-04 PACKER RICHARD A director A - A-Award Stock Option / (Right to Buy) 771 412.68
2021-05-04 Duncan Candace H director A - A-Award Common Stock 300 0
2021-05-04 Duncan Candace H director A - A-Award Stock Option / (Right to Buy) 771 412.68
2021-05-04 HAGGERTY GRETCHEN R director A - A-Award Common Stock 300 0
2021-05-04 HAGGERTY GRETCHEN R director A - A-Award Stock Option / (Right to Buy) 771 412.68
2021-05-04 Klasko Stephen K. M.D. director A - A-Award Common Stock 300 0
2021-05-04 Klasko Stephen K. M.D. director A - A-Award Stock Option / (Right to Buy) 771 412.68
2021-05-04 HEINMILLER JOHN C director A - A-Award Common Stock 300 0
2021-05-04 HEINMILLER JOHN C director A - A-Award Stock Option / (Right to Buy) 771 412.68
2021-04-23 Winters James Corp VP, Mfg and Supply D - F-InKind Common Stock 107 443.71
2021-03-15 Hicks Cameron P Corp. VP & Chief HR Officer A - M-Exempt Common Stock 3000 101.12
2021-03-15 Hicks Cameron P Corp. VP & Chief HR Officer D - S-Sale Common Stock 2000 420.61
2021-03-15 Hicks Cameron P Corp. VP & Chief HR Officer D - S-Sale Common Stock 803 421.66
2021-03-15 Hicks Cameron P Corp. VP & Chief HR Officer A - M-Exempt Common Stock 326 121
2021-03-15 Hicks Cameron P Corp. VP & Chief HR Officer D - S-Sale Common Stock 197 422.47
2021-03-15 Hicks Cameron P Corp. VP & Chief HR Officer D - M-Exempt Stock Option / (Right to Buy) 326 121
2021-03-15 Hicks Cameron P Corp. VP & Chief HR Officer D - M-Exempt Stock Option / (Right to Buy) 3000 101.12
2021-03-02 Kelly Liam Chairman, President & CEO A - A-Award Stock Option / (Right to Buy) 28902 403.78
2021-03-02 Kelly Liam Chairman, President & CEO A - A-Award Common Stock 3694 0
2021-03-02 Deren John VP & Chief Accounting Officer A - A-Award Stock Option / (Right to Buy) 1759 403.78
2021-03-02 Deren John VP & Chief Accounting Officer A - A-Award Common Stock 225 0
2021-03-02 Winters James Corp VP, Mfg and Supply A - A-Award Stock Option / (Right to Buy) 3016 403.78
2021-03-02 Winters James Corp VP, Mfg and Supply A - A-Award Common Stock 385 0
2021-03-02 Hicks Cameron P Corp. VP, HR & Communications A - A-Award Common Stock 460 0
2021-03-02 Hicks Cameron P Corp. VP, HR & Communications A - A-Award Stock Option / (Right to Buy) 3599 403.78
2021-03-02 POWELL THOMAS E Executive Vice President & CFO A - A-Award Common Stock 1329 0
2021-03-02 POWELL THOMAS E Executive Vice President & CFO A - A-Award Stock Option / (Right to Buy) 10399 403.78
2021-03-02 Logue Daniel V. VP, General Counsel, Secretary A - A-Award Common Stock 321 0
2021-03-02 Logue Daniel V. VP, General Counsel, Secretary A - A-Award Stock Option / (Right to Buy) 2513 403.78
2021-03-02 White Jay VP & Pres, Global Commercial A - A-Award Stock Option / (Right to Buy) 3896 403.78
2021-03-02 White Jay VP & Pres, Global Commercial A - A-Award Common Stock 498 0
2021-02-27 Logue Daniel V. VP, General Counsel, Secretary D - F-InKind Common Stock 109 398.12
2021-02-27 Hicks Cameron P Corp. VP, HR & Communications D - F-InKind Common Stock 186 398.12
2021-02-27 Deren John VP & Chief Accounting Officer D - F-InKind Common Stock 129 398.12
2021-02-27 Kelly Liam President & CEO D - F-InKind Common Stock 1282 398.12
2021-02-27 POWELL THOMAS E Executive Vice President & CFO D - F-InKind Common Stock 769 398.12
2021-02-27 White Jay VP & Pres, Global Commercial D - F-InKind Common Stock 118 398.12
2021-02-23 White Jay VP & Pres, Global Commercial D - Common Stock 0 0
2021-02-23 White Jay VP & Pres, Global Commercial D - Stock Option / (Right to Buy) 3356 253.72
2021-02-23 White Jay VP & Pres, Global Commercial D - Stock Option / (Right to Buy) 4428 144.79
2021-02-23 White Jay VP & Pres, Global Commercial D - Stock Option / (Right to Buy) 5468 191.18
2021-02-23 White Jay VP & Pres, Global Commercial D - Common Stock 3676 288.38
2021-02-23 White Jay VP & Pres, Global Commercial D - Stock Option / (Right to Buy) 4010 348.11
2020-12-31 Hicks Cameron P officer - 0 0
2020-12-31 Leyden James J officer - 0 0
2021-01-29 Logue Daniel V. VP, Gen Counsel & Secretary D - Common Stock 0 0
2021-01-29 Logue Daniel V. VP, Gen Counsel & Secretary I - Common Stock 0 0
2021-01-29 Logue Daniel V. VP, Gen Counsel & Secretary D - Stock Option / (Right to Buy) 1276 191.18
2021-01-29 Logue Daniel V. VP, Gen Counsel & Secretary D - Stock Option / (Right to Buy) 1525 101.12
2021-01-29 Logue Daniel V. VP, Gen Counsel & Secretary D - Stock Option / (Right to Buy) 1620 121
2021-01-29 Logue Daniel V. VP, Gen Counsel & Secretary D - Stock Option / (Right to Buy) 1574 144.79
2021-01-29 Logue Daniel V. VP, Gen Counsel & Secretary D - Stock Option / (Right to Buy) 843 253.72
2021-01-29 Logue Daniel V. VP, Gen Counsel & Secretary D - Stock Option / (Right to Buy) 1551 288.38
2021-01-29 Logue Daniel V. VP, Gen Counsel & Secretary D - Stock Option / (Right to Buy) 1180 348.11
2020-12-28 Leyden James J VP, General Counsel, Secretary A - M-Exempt Common Stock 12336 121
2020-12-28 Leyden James J VP, General Counsel, Secretary A - M-Exempt Common Stock 5513 101.12
2020-12-28 Leyden James J VP, General Counsel, Secretary D - F-InKind Common Stock 12378 405.06
2020-12-28 Leyden James J VP, General Counsel, Secretary A - M-Exempt Common Stock 402 82.26
2020-12-28 Leyden James J VP, General Counsel, Secretary A - M-Exempt Common Stock 1832 78.62
2020-12-28 Leyden James J VP, General Counsel, Secretary A - M-Exempt Common Stock 2513 59.75
2020-12-28 Leyden James J VP, General Counsel, Secretary A - M-Exempt Common Stock 3400 57.78
2020-12-28 Leyden James J VP, General Counsel, Secretary D - M-Exempt Stock Option / (Right to Buy) 3400 57.78
2020-12-28 Leyden James J VP, General Counsel, Secretary D - M-Exempt Stock Option / (Right to Buy) 2513 59.75
2020-12-28 Leyden James J VP, General Counsel, Secretary D - M-Exempt Stock Option / (Right to Buy) 1832 78.62
2020-12-28 Leyden James J VP, General Counsel, Secretary D - M-Exempt Stock Option / (Right to Buy) 402 82.26
2020-12-28 Leyden James J VP, General Counsel, Secretary D - M-Exempt Stock Option / (Right to Buy) 5513 101.12
2020-12-28 Leyden James J VP, General Counsel, Secretary D - M-Exempt Stock Option / (Right to Buy) 12336 121
2020-11-30 Hicks Cameron P Corp. VP, HR & Communications A - M-Exempt Common Stock 2985 85.54
2020-12-02 Hicks Cameron P Corp. VP, HR & Communications A - M-Exempt Common Stock 500 121
2020-12-02 Hicks Cameron P Corp. VP, HR & Communications A - M-Exempt Common Stock 588 101.12
2020-12-02 Hicks Cameron P Corp. VP, HR & Communications D - M-Exempt Stock Option / (Right to Buy) 500 121
2020-11-30 Hicks Cameron P Corp. VP, HR & Communications D - S-Sale Common Stock 2985 371
2020-12-02 Hicks Cameron P Corp. VP, HR & Communications D - M-Exempt Stock Option / (Right to Buy) 588 101.12
2020-11-30 Hicks Cameron P Corp. VP, HR & Communications D - M-Exempt Stock Option / (Right to Buy) 2985 85.54
2020-10-26 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 200 58.25
2020-10-26 Klasko Stephen K. M.D. director D - S-Sale Common Stock 200 361.38
2020-10-26 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 200 58.25
2020-09-25 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 200 58.25
2020-09-25 Klasko Stephen K. M.D. director D - S-Sale Common Stock 200 326.15
2020-09-25 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 200 58.25
2020-08-25 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 200 58.25
2020-08-25 Klasko Stephen K. M.D. director D - S-Sale Common Stock 200 373.74
2020-08-25 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 200 58.25
2020-07-27 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 200 58.25
2020-07-27 Klasko Stephen K. M.D. director D - S-Sale Common Stock 200 386.35
2020-07-27 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 200 58.25
2020-06-25 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 200 58.25
2020-06-25 Klasko Stephen K. M.D. director D - A-Award Common Stock 200 356.07
2020-06-25 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 200 58.25
2020-05-26 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 200 58.25
2020-05-26 Klasko Stephen K. M.D. director D - S-Sale Common Stock 200 375.14
2020-05-26 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 200 58.25
2020-05-09 Deren John VP & Chief Accounting Officer D - F-InKind Common Stock 38 340.3
2020-05-07 Hicks Cameron P Corp. VP, HR & Communications A - M-Exempt Common Stock 1400 85.54
2020-05-11 Hicks Cameron P Corp. VP, HR & Communications A - M-Exempt Common Stock 400 101.12
2020-05-11 Hicks Cameron P Corp. VP, HR & Communications A - M-Exempt Common Stock 507 85.54
2020-05-07 Hicks Cameron P Corp. VP, HR & Communications D - S-Sale Common Stock 1400 343.57
2020-05-11 Hicks Cameron P Corp. VP, HR & Communications D - M-Exempt Stock Option / (Right to Buy) 400 101.12
2020-05-07 Hicks Cameron P Corp. VP, HR & Communications D - M-Exempt Stock Option / (Right to Buy) 1400 85.54
2020-05-11 Hicks Cameron P Corp. VP, HR & Communications D - M-Exempt Stock Option / (Right to Buy) 507 85.54
2020-05-05 Klasko Stephen K. M.D. director A - A-Award Stock Option / (Right to Buy) 1187 340.75
2020-05-05 Klasko Stephen K. M.D. director A - A-Award Common Stock 383 0
2020-05-05 HAGGERTY GRETCHEN R director A - A-Award Common Stock 383 0
2020-05-05 HAGGERTY GRETCHEN R director A - A-Award Stock Option / (Right to Buy) 1187 340.75
2020-05-05 HEINMILLER JOHN C director A - A-Award Common Stock 383 0
2020-05-05 HEINMILLER JOHN C director A - A-Award Stock Option / (Right to Buy) 1187 340.75
2020-05-05 Deren John VP & Chief Accounting Officer D - S-Sale Common Stock 826 330.2365
2020-05-05 Deren John VP & Chief Accounting Officer D - S-Sale Common Stock 267 329.6688
2020-05-05 BABICH GEORGE JR director A - A-Award Common Stock 514 0
2020-05-05 BABICH GEORGE JR director A - A-Award Stock Option / (Right to Buy) 1187 340.75
2020-05-05 PACKER RICHARD A director A - A-Award Common Stock 383 0
2020-05-05 PACKER RICHARD A director A - A-Award Stock Option / (Right to Buy) 1187 340.75
2020-05-05 Duncan Candace H director A - A-Award Common Stock 383 0
2020-05-05 Duncan Candace H director A - A-Award Stock Option / (Right to Buy) 1187 340.75
2020-05-05 Krakauer Andrew A director A - A-Award Common Stock 383 0
2020-05-05 Krakauer Andrew A director A - A-Award Stock Option / (Right to Buy) 1187 340.75
2020-05-05 RANDLE STUART A director A - A-Award Common Stock 383 0
2020-05-05 RANDLE STUART A director A - A-Award Stock Option / (Right to Buy) 1187 340.75
2020-04-27 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 200 58.25
2020-04-27 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 200 58.25
2020-04-27 Klasko Stephen K. M.D. director D - S-Sale Common Stock 200 342.26
2020-03-25 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 200 58.25
2020-03-25 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 200 58.25
2020-03-25 Klasko Stephen K. M.D. director D - S-Sale Common Stock 200 254.75
2020-02-28 Deren John VP & Chief Accounting Officer A - M-Exempt Common Stock 969 253.72
2020-02-28 Deren John VP & Chief Accounting Officer A - M-Exempt Common Stock 1215 191.18
2020-02-28 Deren John VP & Chief Accounting Officer D - F-InKind Common Stock 154 335.02
2020-02-28 Deren John VP & Chief Accounting Officer D - S-Sale Common Stock 2184 346.17
2020-02-28 Deren John VP & Chief Accounting Officer D - M-Exempt Stock Option / (Right to Buy) 969 253.72
2020-02-28 Deren John VP & Chief Accounting Officer D - M-Exempt Stock Option / (Right to Buy) 1215 191.18
2020-02-28 Hicks Cameron P Vice President, Global HR D - F-InKind Common Stock 266 335.02
2020-02-28 Leyden James J VP, General Counsel, Secretary D - F-InKind Common Stock 380 335.02
2020-02-28 POWELL THOMAS E Executive Vice President & CFO D - F-InKind Common Stock 1035 335.02
2020-02-28 Kelly Liam President & CEO D - F-InKind Common Stock 1031 335.02
2020-02-25 Deren John VP & Chief Accounting Officer A - A-Award Common Stock 222 0
2020-02-25 Deren John VP & Chief Accounting Officer A - A-Award Stock Option / (Right to Buy) 2167 348.11
2020-02-27 Leyden James J VP, General Counsel, Secretary A - M-Exempt Common Stock 3200 61.34
2020-02-27 Leyden James J VP, General Counsel, Secretary D - F-InKind Common Stock 705 344.44
2020-02-27 Leyden James J VP, General Counsel, Secretary D - S-Sale Common Stock 400 344.26
2020-02-27 Leyden James J VP, General Counsel, Secretary D - S-Sale Common Stock 350 344.2943
2020-02-25 Leyden James J VP, General Counsel, Secretary A - A-Award Common Stock 614 0
2020-02-25 Leyden James J VP, General Counsel, Secretary A - A-Award Stock Option / (Right to Buy) 5996 348.11
2020-02-27 Leyden James J VP, General Counsel, Secretary D - M-Exempt Stock Option / (Right to Buy) 3200 61.34
2020-02-25 Hicks Cameron P Vice President, Global HR A - A-Award Common Stock 410 0
2020-02-25 Hicks Cameron P Vice President, Global HR A - A-Award Stock Option / (Right to Buy) 3997 348.11
2020-02-25 Wijker Mario Vice President, QARA A - A-Award Stock Option / (Right to Buy) 1940 348.11
2020-02-25 Wijker Mario Vice President, QARA A - A-Award Common Stock 199 0
2020-02-25 Kelly Liam President & CEO A - A-Award Stock Option / (Right to Buy) 31371 348.11
2020-02-25 Kelly Liam President & CEO A - A-Award Common Stock 3215 0
2020-02-25 Winters James Vice President, Mfg and Supply A - A-Award Stock Option / (Right to Buy) 3234 348.11
2020-02-25 Winters James Vice President, Mfg and Supply A - A-Award Common Stock 331 0
2020-02-25 POWELL THOMAS E Executive Vice President & CFO A - A-Award Stock Option / (Right to Buy) 12992 348.11
2020-02-25 POWELL THOMAS E Executive Vice President & CFO A - A-Award Common Stock 1331 0
2020-02-25 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 200 58.25
2020-02-25 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 200 58.25
2020-02-25 Klasko Stephen K. M.D. director D - S-Sale Common Stock 200 360.95
2020-02-18 Winters James Vice President, Mfg and Supply D - Common Stock 0 0
2020-02-18 Winters James Vice President, Mfg and Supply D - Stock Option / (Right to Buy) 1729 271.7
2020-02-18 Winters James Vice President, Mfg and Supply D - Stock Option / (Right to Buy) 3214 288.38
2020-02-18 Wijker Mario Vice President, QARA D - Common Stock 0 0
2020-02-18 Wijker Mario Vice President, QARA D - Stock Option / (Right to Buy) 1003 252.38
2020-02-18 Wijker Mario Vice President, QARA D - Stock Option / (Right to Buy) 1594 288.38
2020-02-18 Wijker Mario Vice President, QARA D - Stock Option / (Right to Buy) 592 362.69
2020-02-18 SMITH BENSON director D - F-InKind Common Stock 1106 376.44
2019-12-31 Leyden James J officer - 0 0
2020-01-27 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 200 58.25
2020-01-27 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 200 58.25
2020-01-27 Klasko Stephen K. M.D. director D - S-Sale Common Stock 200 375.71
2019-12-26 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 200 61.34
2019-12-26 Klasko Stephen K. M.D. director D - S-Sale Common Stock 200 374.35
2019-12-26 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 200 61.34
2019-11-29 Hicks Cameron P Vice President, Global HR A - M-Exempt Common Stock 1000 85.54
2019-11-29 Hicks Cameron P Vice President, Global HR D - M-Exempt Stock Option / (Right to Buy) 1000 85.54
2019-11-26 Hicks Cameron P Vice President, Global HR A - M-Exempt Common Stock 1300 85.54
2019-11-25 Hicks Cameron P Vice President, Global HR D - G-Gift Common Stock 270 0
2019-11-26 Hicks Cameron P Vice President, Global HR D - S-Sale Common Stock 1300 350
2019-11-26 Hicks Cameron P Vice President, Global HR D - M-Exempt Stock Option / (Right to Buy) 1300 85.54
2019-11-26 POWELL THOMAS E Executive Vice President & CFO A - M-Exempt Common Stock 5000 121
2019-11-26 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 1000 347.31
2019-11-26 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 4000 349.05
2019-11-26 POWELL THOMAS E Executive Vice President & CFO D - M-Exempt Stock Option / (Right to Buy) 5000 121
2019-11-25 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 200 61.34
2019-11-25 Klasko Stephen K. M.D. director D - S-Sale Common Stock 200 346.63
2019-11-25 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 200 61.34
2019-11-12 POWELL THOMAS E Executive Vice President & CFO A - M-Exempt Common Stock 7500 121
2019-11-12 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 345 328.03
2019-11-12 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 1868 329.87
2019-11-12 POWELL THOMAS E Executive Vice President & CFO D - M-Exempt Stock Option / (Right to Buy) 7500 121
2019-11-12 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 5287 331.11
2019-11-04 SMITH BENSON director A - M-Exempt Common Stock 8481 59.75
2019-11-04 SMITH BENSON director D - S-Sale Common Stock 1400 343.66
2019-11-04 SMITH BENSON director D - S-Sale Common Stock 2405 345.03
2019-11-04 SMITH BENSON director D - S-Sale Common Stock 4163 345.89
2019-11-04 SMITH BENSON director D - S-Sale Common Stock 113 346.5
2019-11-04 SMITH BENSON director D - S-Sale Common Stock 400 347.76
2019-11-04 SMITH BENSON director D - M-Exempt Stock Option / (Right to Buy) 8481 59.75
2019-10-31 SMITH BENSON director A - M-Exempt Common Stock 17000 59.75
2019-10-31 SMITH BENSON director D - S-Sale Common Stock 16573 340
2019-10-31 SMITH BENSON director D - S-Sale Common Stock 427 340.275
2019-10-31 SMITH BENSON director D - M-Exempt Stock Option / (Right to Buy) 17000 59.75
2019-10-29 POWELL THOMAS E Executive Vice President & CFO D - M-Exempt Stock Option / (Right to Buy) 7500 121
2019-10-29 POWELL THOMAS E Executive Vice President & CFO A - M-Exempt Common Stock 7500 121
2019-10-29 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 465 325.36
2019-10-29 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 3216 326.96
2019-10-29 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 3819 328.05
2019-10-25 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 200 61.34
2019-10-25 Klasko Stephen K. M.D. director D - S-Sale Common Stock 200 316.0073
2019-10-25 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 200 61.34
2019-10-15 POWELL THOMAS E Executive Vice President & CFO D - M-Exempt Stock Option / (Right to Buy) 658 121
2019-10-15 POWELL THOMAS E Executive Vice President & CFO A - M-Exempt Common Stock 658 121
2019-10-15 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 200 324.78
2019-10-15 POWELL THOMAS E Executive Vice President & CFO A - M-Exempt Common Stock 6842 101.12
2019-10-15 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 759 326.81
2019-10-15 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 1051 327.77
2019-10-15 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 5490 328.93
2019-10-15 POWELL THOMAS E Executive Vice President & CFO D - M-Exempt Stock Option / (Right to Buy) 6842 101.12
2019-10-01 POWELL THOMAS E Executive Vice President & CFO A - M-Exempt Common Stock 7500 101.12
2019-10-01 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 79 333.57
2019-10-01 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 627 335.41
2019-10-01 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 1260 336.35
2019-10-01 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 1534 337.5
2019-10-01 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 1300 338.73
2019-10-01 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 2700 339.73
2019-10-01 POWELL THOMAS E Executive Vice President & CFO D - M-Exempt Stock Option / (Right to Buy) 7500 101.12
2019-09-25 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 200 61.34
2019-09-25 Klasko Stephen K. M.D. director D - S-Sale Common Stock 200 342.5
2019-09-25 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 200 61.34
2019-09-23 SMITH BENSON director A - M-Exempt Common Stock 8500 59.75
2019-09-23 SMITH BENSON director D - S-Sale Common Stock 8500 340
2019-09-23 SMITH BENSON director D - M-Exempt Stock Option / (Right to Buy) 8500 59.75
2019-09-20 SMITH BENSON director D - G-Gift Common Stock 28550 0
2019-09-20 SMITH BENSON director A - G-Gift Common Stock 19030 0
2019-09-20 SMITH BENSON director A - G-Gift Common Stock 9520 0
2019-09-17 POWELL THOMAS E Executive Vice President & CFO A - M-Exempt Common Stock 7500 101.12
2019-09-17 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 1500 330
2019-09-17 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 554 332.11
2019-09-17 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 1332 333.11
2019-09-17 POWELL THOMAS E Executive Vice President & CFO D - M-Exempt Stock Option / (Right to Buy) 7500 101.12
2019-09-17 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 4114 334
2019-09-06 POWELL THOMAS E Executive Vice President & CFO D - M-Exempt Stock Option / (Right to Buy) 7500 101.12
2019-09-06 POWELL THOMAS E Executive Vice President & CFO A - M-Exempt Common Stock 7500 101.12
2019-09-06 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 6119 355.32
2019-09-06 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 1281 356.36
2019-09-06 POWELL THOMAS E Executive Vice President & CFO D - S-Sale Common Stock 100 357.27
2019-08-26 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 200 61.34
2019-08-26 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 200 61.34
2019-08-26 Klasko Stephen K. M.D. director D - S-Sale Common Stock 200 361.06
2019-08-15 Hicks Cameron P Vice President, Global HR A - M-Exempt Common Stock 1000 85.54
2019-08-15 Hicks Cameron P Vice President, Global HR D - M-Exempt Stock Option / (Right to Buy) 1000 85.54
2019-08-15 Hicks Cameron P Vice President, Global HR D - S-Sale Common Stock 1000 370
2019-08-14 Deren John VP & Chief Accounting Officer A - M-Exempt Common Stock 969 253.72
2019-08-14 Deren John VP & Chief Accounting Officer A - M-Exempt Common Stock 632 194.4
2019-08-14 Deren John VP & Chief Accounting Officer D - S-Sale Common Stock 1601 364.9477
2019-08-14 Deren John VP & Chief Accounting Officer D - S-Sale Common Stock 403 365.5304
2019-08-14 Deren John VP & Chief Accounting Officer D - M-Exempt Stock Option / (Right to Buy) 969 253.72
2019-08-14 Deren John VP & Chief Accounting Officer D - M-Exempt Stock Option / (Right to Buy) 632 194.4
2019-07-25 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 200 61.34
2019-07-25 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 200 61.34
2019-07-25 Klasko Stephen K. M.D. director D - S-Sale Common Stock 200 343.28
2019-07-17 SMITH BENSON director A - M-Exempt Common Stock 8500 59.75
2019-07-17 SMITH BENSON director D - S-Sale Common Stock 1900 332.06
2019-07-17 SMITH BENSON director D - S-Sale Common Stock 6600 332.82
2019-07-17 SMITH BENSON director D - M-Exempt Stock Option / (Right to Buy) 8500 59.75
2019-07-03 SMITH BENSON director A - M-Exempt Common Stock 8500 59.75
2019-07-03 SMITH BENSON director D - S-Sale Common Stock 2200 331.43
2019-07-03 SMITH BENSON director D - S-Sale Common Stock 6200 332.06
2019-07-03 SMITH BENSON director D - S-Sale Common Stock 100 332.72
2019-07-03 SMITH BENSON director D - M-Exempt Stock Option / (Right to Buy) 8500 59.75
2019-06-25 Klasko Stephen K. M.D. director D - M-Exempt Stock Option / (Right to Buy) 200 61.34
2019-06-25 Klasko Stephen K. M.D. director A - M-Exempt Common Stock 200 61.34
2019-06-25 Klasko Stephen K. M.D. director D - S-Sale Common Stock 200 332.17
2019-06-20 Boylan Karen VP, Global Strategic Projects A - M-Exempt Common Stock 1149 78.62
2019-06-20 Boylan Karen VP, Global Strategic Projects D - S-Sale Common Stock 1149 333.215
2019-06-20 Boylan Karen VP, Global Strategic Projects D - M-Exempt Stock Option / (Right to Buy) 1149 78.62
2019-06-18 RANDLE STUART A director D - S-Sale Common Stock 2700 330.317
2019-06-18 RANDLE STUART A director D - S-Sale Common Stock 300 330.385
2019-06-18 RANDLE STUART A director D - G-Gift Common Stock 253 329.71
2019-06-18 Hicks Cameron P Vice President, Global HR D - M-Exempt Stock Option / (Right to Buy) 700 85.54
2019-06-18 Hicks Cameron P Vice President, Global HR A - M-Exempt Common Stock 700 85.54
2019-06-18 Hicks Cameron P Vice President, Global HR D - S-Sale Common Stock 700 330.7
2019-06-19 SMITH BENSON director A - M-Exempt Common Stock 8500 59.75
2019-06-19 SMITH BENSON director D - S-Sale Common Stock 1800 329.41
2019-06-19 SMITH BENSON director D - S-Sale Common Stock 3741 330.47
2019-06-19 SMITH BENSON director D - S-Sale Common Stock 712 331.37
2019-06-19 SMITH BENSON director D - S-Sale Common Stock 2247 332.09
2019-06-19 SMITH BENSON director D - M-Exempt Stock Option / (Right to Buy) 8500 59.75
2019-06-05 SMITH BENSON director A - M-Exempt Common Stock 8500 59.75
2019-06-05 SMITH BENSON director D - S-Sale Common Stock 300 293.59
2019-06-05 SMITH BENSON director D - S-Sale Common Stock 2937 295.2
2019-06-05 SMITH BENSON director D - S-Sale Common Stock 2453 296.12
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Transcripts
Operator:
Good morning, ladies and gentlemen, and welcome to the Teleflex First Quarter 2024 Earnings Conference Call. [Operator Instructions] Please note that this conference call is being recorded and will be available on the company's website for replay shortly.
And now I will turn the call over to Mr. Lawrence Keusch, Vice President of Investor Relations and Strategy Development.
Lawrence Keusch:
Good morning, everyone, and welcome to the Teleflex Inc. First Quarter 2024 Earnings Conference Call. The press release and slides to accompany this call are available on our website at teleflex.com.
As a reminder, a replay will be available on our website. Those wishing to access the replay can refer to our press release from this morning for detail. Participating on today's call are Liam Kelly, Chairman, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks, and then we will open the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in the slides posted to the Investor Relations section of the Teleflex website. We wish to caution you that such statements are, in fact, forward looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. Now I'll turn the call over to Liam for his remarks.
Liam Kelly:
Thank you, Larry, and good morning, everyone. On this morning's call, we will discuss the first quarter results, review some commercial highlights and provide an update on our financial guidance for 2024. We had a solid start to 2024 as momentum seen through last year continued into the first quarter.
For the quarter, Teleflex revenues were $737.8 million, up 3.8% year-over-year on both a GAAP and constant currency basis. First quarter adjusted earnings per share was $3.21, a 3.9% increase year-over-year. During the quarter, utilization for our products trended positively and tracks to our expectations. While we do not expect a revenue benefit from pent-up demand due to the broad exposure of the Teleflex portfolio to critical care procedures, we are seeing utilization back to pre-pandemic levels. Turning to raw material inflation. We saw positive trends during the first quarter with year-over-year disinflation tracking towards our expectations for the year. Nonetheless, we continue to expect total inflation to be somewhat higher in 2024 as compared to 2023 in part due to inventory capitalized in 2023, impacting the income statement this year. I would also like to provide an update on our logistics and distribution infrastructure. Our freight expenses continue to show positive trends. Despite the conflict in the Middle East, we continue to maintain customer service levels by successfully diverting shipments to alternative shipping lanes. In addition, I would note that we do not utilize the Port of Baltimore to ship Teleflex products to or from our North American distribution center. Now let's turn to a deeper dive into our first quarter revenue results. I will begin with a review of our geographic segment revenues for the first quarter. All growth rates that I referred to are on a constant currency basis unless otherwise noted. Americas revenues were $406.3 million, a 1.5% decrease year-over-year. Investors familiar with Teleflex will be aware that prior year MSA revenues were booked in the Americas. EMEA revenues of $159.6 million increased 9.7% year-over-year. Growth was seen across the majority of our product families, including solid double-digit growth contributions from Interventional and Interventional Urology. The region also benefited from the ongoing recovery of ET tubes following the recall last year. Now turning to Asia. Revenues were $84.2 million, an 11.2% increase year-over-year. Revenue growth was broad-based across the region with double-digit increases in China, India and Southeast Asia. Let's now move to a discussion on our first quarter revenues by global products category. Commentary on global product category growth for the first quarter will also be on a year-over-year constant currency basis. Starting with Vascular Access. Revenue increased 2% year-over-year to $181.4 million. The quarter was led by underlying growth in PICCs, central access and EZ-IO partly offset by the impact of the previously announced Endurance catheter recall. We will anniversary the Endurance recall during the second quarter, and we continue to see opportunities for share gains in the peripheral access market. Moving to Interventional. Revenue was $134.7 million, an increase of 15.4% year-over-year. We demonstrated growth across our geographic segments as our portfolio of growth drivers continues to perform well. During the quarter, growth was led by balloon pumps, MANTA and complex catheters. Turning to Anesthesia. Revenue increased 3.2% year-over-year to $96.4 million. Growth was balanced across the portfolio. Of note, we continue to recover from the ET tube recall initiated during the second quarter of 2023 and will fully anniversary the revenue comparisons at the end of next quarter. In our Surgical business, revenue was $105.5 million, an increase of 7.1% year-over-year against a tough comparison. Our underlying trends in our core surgical franchise continued to be solid. Among our largest franchises, growth was led by [indiscernible], instrumentation and our ligation portfolio. For Interventional Urology, revenue was $79.7 million, representing an increase of 6.1% year-over-year. Growth was driven by Barrigel revenue following the October 2023 acquisition of Palette Life Sciences. And as anticipated, UroLift growth was impacted by continued challenges in the office side of service and sales force training activities for Barrigel during the quarter. Our full year 2024 Interventional Urology total revenue guidance continues to assume approximately 7.5% growth, which continues to incorporate Palette revenues in the range of $66 million to $68 million for 2024. OEM had another solid quarter with revenues increasing 13.6% year-over-year to $87.7 million. Our 3 largest product categories recorded double-digit growth in the quarter, including continued strength in microcatheters. In addition, we saw some modest benefit from order timing shifting from the second quarter into the first quarter. First quarter other revenue declined 27.1% to $52.4 million year-over-year. The decline in revenue on a year-over-year basis is primarily due to the planned December 2023 exit of the MSA by Medline. That completes my comments on the first quarter revenue performance. Turning to some commercial and clinical updates. Starting with an update on Palette Life Sciences, our most recent acquisition. We have now owned Palette Life Sciences for just over 6 months, and I am pleased to report that the integration process is meeting our targeted milestones. Cross-functional product sales training continued to progress throughout the first quarter and the first phase of training for our jewel bag reps will be completed at the end of the second quarter. During the quarter, we were active training and proctoring the legacy UroLift sales force on the use of Barrigel, and we remain on track to fully complete the integration of the sales force by the end of 2024. Moving to a couple of product updates. In our Interventional Access business, we initiated a limited market release of the Wattson temporary pacing guidewire. Wattson will complement our expanding structural heart portfolio, which already includes the MANTA, large bore closure device and the Langston Dual-Lumen for contrast delivery and pressure measurement. In our Surgical business, we are pleased to share that the Titan SGS stapler is now available with GORE SEAMGUARD Bioabsorbable staple line reinforcement material. This complementary pairing supports bariatric surgeons by addressing clinical preferences in the sleeve gastrectomy market. As we look further into 2024, we will continue to advance our new product introductions with a number of launches across our business units. In our Interventional Access business, there is no change to our expectation for an FDA marketing clearance and a limited market release of the Ringer catheter in the second half of 2024. Ringer incorporates a unique balloon design that allows blood to flow through a vessel while the balloon is inflated. We expect to initially launch with a PTCA indication but we'll evaluate opportunities for label expansion following the completion of our vessel perforation trial. Finally, I will provide a regulatory update. In February, we voluntarily initiated a recall of our QuickFlash radial artery and radial artery arterial line catheterization kits after receiving reports of increased resistance in the Guidewire handle and chamber during use. The financial impact from this recall was de minimis. In cooperation with the FDA Teleflex also recently initiated a voluntary field advisory notice for Arrow FiberOptix and UltraFLEX intra-aortic balloon catheter kits. Due to reports indicating and infrequent condition, which were not identified and corrected promptly, could result in serious health consequences, including a reduction or loss of the hemodynamic support normally provided by intra-aortic balloon pump therapy. The FDA has not yet designated a recall classification. But under the field advisory notice, customers may continue to use the products in scope per additional instructions, warnings and cautions. We expect the financial impact from the voluntary field action to be immaterial. That completes my prepared remarks. Now I'd like to turn the call over to Tom for a more detailed review of our first quarter financial results. Tom?
Thomas Powell:
Thanks, Liam, and good morning. Given the previous discussion of the company's revenue performance, I'll begin with margins. For the quarter, adjusted gross margin was 61.1%, a 170 basis point increase versus the prior year period. The year-over-year increase was primarily due to the favorable impact of gross margin from the termination of the MSA, the acquisition of Palette, favorable price benefits from cost improvement initiatives, partially offset by unfavorable fluctuations in foreign exchange rates and continued cost inflation.
Adjusted operating margin was 26.6% in the first quarter. The 80 basis point year-over-year increase was primarily driven by the flow-through of the year-over-year increase in gross margin partially offset by the inclusion of Palette Life Science, operating expenses, employee-related expenses and investments to grow the business. Net interest expense totaled $21 million in the first quarter, an increase from $17.5 million in the prior year period. The year-over-year increase in net interest expense reflects higher interest rates versus the prior year and higher average debt outstanding utilized to fund the acquisition of Palette, partially offset by increased interest income. Our adjusted tax rate for the first quarter of 2024 was 13.2% compared to 11.8% in the prior year period. The year-over-year increase in our adjusted tax rate is primarily due to additional costs arising from the enactment of European Pillar 2 tax reform and realization of discrete items in the quarter. At the bottom line, first quarter adjusted earnings per share was $3.21, an increase of 3.9% versus prior year. The year-over-year increase in EPS reflects dilution from the acquisition of Palette Life Sciences and the related incremental borrowings. Turning now to select balance sheet and cash flow highlights. Cash flow from operations for the first quarter was $112.8 million compared to $84.3 million in the prior year period. The $28.5 million increase was primarily attributable to favorable operating results and a decrease in cash outflows from inventories as we moderate our inventory levels due to improving supply chain dynamics, partially offset by an increase in accounts receivable resulting from higher sales and lower levels of accounts payable and accrued expenses. Moving to the balance sheet. At the end of the first quarter, our cash balance was $237.4 million as compared to $222.8 million as of year-end 2023. The increase in cash on hand is primarily due to operating cash flows. Net leverage at quarter end was approximately 1.7x. Inclusive of the debt associated with the acquisition of Palette Life Sciences, our financial position remains sound and continues to provide us flexibility to execute on our long-term capital allocation strategy. Turning to financial guidance. We are pleased with the solid start to the year and are making select updates to the outlook for 2024. We continue to expect 2024 constant currency revenue growth of 3.75% to 4.75%. The year-over-year growth includes the loss of the $75.7 million in MSA revenues partly offset by the incremental revenues from Palette in the range of $66 million to $68 million, which Liam mentioned earlier. Turning to foreign exchange. We now assume a negative impact from foreign exchange of approximately $12 million, representing a 40 basis point headwind to GAAP growth in 2024. This compares to our prior guidance of approximately $5 million or 15 basis point headwind for 2024. The updated guidance of a $12 million foreign exchange headwind assumes approximately a $1.07 average euro exchange rate for 2024 versus the prior guidance, which had assumed approximately $1.08. Considering the foreign exchange outlook, we expect reported revenue growth of 3.35% to 4.35% in 2024, implying a dollar range of $3.074 billion to $3.104 billion. For your modeling purposes, the 2024 outlook includes an assumption of $760 million to $765 million in revenues for the second quarter, representing growth in the range of 3.1% to 3.8% year-over-year, excluding an FX headwind of approximately $6 million. We reiterate our expectation for 2024 gross margin to be in the range of 60% to 60.75%. Our gross margin guidance reflects the year-over-year positive impacts from the termination of the MSA, manufacturing efficiencies, price and the Palette acquisition partially offset by inflation and the impact of changes in foreign currency exchange rates. We also continue to expect operating margin to be in the range of 26.25% to 26.75% for 2024. Our guidance reflects the flow-through of gross margin and the positive impact of restructuring, offset by the inclusion of operating expenses for Palette Life Sciences and investments to grow the business. Moving to items below the line. Net interest expense is expected to approximate $78 million for 2024. The majority of the year-over-year increase in our net interest expense outlook reflects the impact of borrowings associated with the Palette acquisition, higher interest rates, partially offset by planned debt repayments during 2024. Our tax rate is expected to be approximately 12% for 2024, which reflects favorable mix offset by discrete items in 2023 that will not repeat in 2024 and the impact of the Pillar 2 global minimum tax. Turning to earnings. We are raising the low end of guidance by $0.05, which reflects the strong results in the first quarter and the updated foreign exchange headwind. In turn, we now expect 2024 adjusted earnings per share to be in a range of $13.60 to $13.95. Finally, our 2024 adjusted EPS outlook reflects $0.87 in year-over-year headwinds from incremental dilution associated with the acquisition of Palette, the termination of the MSA, the year-over-year increase in our tax rate, primarily due to the Pillar 2 minimum tax and the updated foreign exchange headwind of $0.28. After adjusting for these headwinds, year-over-year underlying adjusted constant currency EPS growth is approximately 7% on the low end of guidance and 10% on the high end of guidance. That concludes my prepared remarks. I would now like to turn it back to Liam for closing commentary.
Liam Kelly:
Thanks, Tom. In closing, I will highlight our 3 key takeaways from the first quarter of 2024. First, we started 2024 with a solid performance as momentum continued from the end of last year. Overall, our diversified portfolio and global business units performed well.
We managed operating expenses and continued to focus on new product introductions in 2024. Netting the loss of MSA revenues, the incremental palette sales and the revised foreign exchange headwind, we anticipate an approximately 100 basis points year-over-year headwind to growth in 2024. Second, we are well positioned to deliver on our financial guidance for 2024. We remain highly focused on executing on our plan for the year, just as we did in 2023. Third, we will continue to focus on our strategy to drive durable growth. We will invest in organic growth opportunities and drive innovation over time, expand our margins and execute on our disciplined capital allocation strategy to enhance long-term value creation. The integration of Palette Life Sciences is progressing well, and we expect the acquisition to be a meaningful contributor to our growth in the coming years. That concludes my prepared remarks. Now I would like to turn the call back to the operator for Q&A.
Operator:
[Operator Instructions] Your first question will come from the line of Patrick Wood from Morgan Stanley.
Patrick Andrew Wood:
I guess for the first one, I'm curious about OEM, another very strong quarter. There's kind of a lot of different pieces moving in there. The volume environment is very good. But equally, there's a little bit of competitive noise backwards and forwards. I'm just -- I'm curious how you see that evolving through the year.
You've mentioned a little bit of phasing as some stuff was pulled into Q1, but should we expect more of a normalization in the second half or similar kinds of growth patterns we've seen so far?
Liam Kelly:
Patrick, thank you very much for the question. I think that OEM was definitely one of the standouts again within the quarter, but there were many standouts for Teleflex in the quarter, in my mind, a really strong quarter, a great start to the year, growing our revenues at 3.8% and growing our earnings faster than revenues at 3.9% and raising the bottom end of our earnings guide while covering some FX impact.
On to OEM, I do anticipate the phasing as we go through the year, I think OEM is well capable of doing double-digit growth in the entirety of the year. It will probably take a little bit of a step back in Q2 just to the phasing of the orders, as you outlined. But the underlying growth is really strong. The order bank is strong, very strong on [indiscernible] microcatheters following on from the HPC acquisition a number of years ago. Catheter extrusions continues to be strong. Demand is robust, and I think the environment continues to be good for the OEM business. And even though OEM is dilutive to our gross margins, I would like to remind everybody, it is accretive to our operating margins and therefore, a good contributor to Teleflex as it grows.
Patrick Andrew Wood:
And then just quickly on the second one. Within the Urology side of things, obviously, you pulled a bit of the sales force back to get some of the training going. A, sort of how is that going? How has the response been internally? And b, how disruptive is that? How long does that kind of training process take? I know it's kind of an open-ended question, but just curious.
Liam Kelly:
No, that's a fair question, Patrick. I think that the training is going well. So we are proctoring our sales reps. We have about as we ended the first quarter, we have roughly around 40% of them trained that need to be trained in this phase. So this will be completed at the end of Q2.
And then over the remainder of the year, we'll take a systematic approach to onboarding additional reps and full bagging them. We would anticipate that the organization will be fully integrated and all the trains will be pretty much done by the end of this year and Palette will be integrated. The good news is that it has had 0 impact. While it did have some impact on UroLift, it had 0 impact on Palette. And Palette again, 6 months into our ownership is performing very well.
Operator:
Your next question comes from the line of Jayson Bedford from Raymond James.
Jayson Bedford:
Maybe just to start for Tom. The first quarter gross margin was above your full year guidance. Revenue will increase from first quarter levels. So what pressures gross margin over the next 3 quarters?
Thomas Powell:
Well, I wouldn't say there's anything that necessarily is pressuring over the next number of quarters other than what we already saw in the first quarter, which we've got inflationary pressures. We've got some FX, although we expect FX to improve as the quarters go on.
So obviously, we had a really solid start to the year. We provided full year guidance and are working towards that. I would say that as a result of the strong start, we feel really good about achieving that guidance, and we'll continue to monitor the situation and provide any updates in the future as the situation warrants.
Jayson Bedford:
Okay. Fair enough. And then just maybe as a quick unrelated follow-up. Interventional, very strong of a tough comp Liam, you alluded to a few drivers, but just a little bit more granularity. Is this excess share gain? Is there a new product in there that's driving this growth?
Liam Kelly:
So I wouldn't exactly call it a new product. But obviously, MANTA continues to penetrate the large bore market, really solid double-digit growth coming from that product specifically complex catheters, which is the bread and butter of this franchise, which is the guideline or trap line or Turnpike. They continue to grow within the market.
And obviously, then you have our intra-aortic balloon pumps and catheters, really strong performance from them, in particular, overseas. So across the board, I think it's a procedure of volumes globally in the cath lab are back to pre-pandemic levels. We're getting some benefit from that, but also further penetrating in our accounts having a suite of products to surround MANTA and now having the Wattson coming to the market in a limited market launch only helps to compound that growth within the cath lab space.
Operator:
Your next question comes from the line of Shagun Singh from RBC Capital Markets.
Shagun Singh Chadha:
Liam, your guidance calls for about 4.25% growth in 2024 at the midpoint versus 6.5% last year and your LRP target of the low end of 6% to 7%. I know you called out some year-over-year factors to consider. But I'm just wondering what accelerates the growth profile for the company from here? How are you thinking about M&A boosting your weighted average market growth. And if you could put all this in the context of your utilization commentary, it seems like there isn't a backlog, but there is still healthy demand. That would be really helpful.
Liam Kelly:
No, absolutely, Shagun. And thank you very much for the question. So the midpoint of our guide, you're correct at the midpoint. And now I would remind the investment community as we laid out in -- as we gave our guide, there is approximately 1% of a headwind from an inorganic with the MSA in palette.
So if you look at our guide of 3.75% to 4.75%, the organic growth underlying that is 4.75% to 5.75%. So your jump off into next year will be at a higher rate from a growth level because the MSA will be anniversaried in the fourth quarter. I think the outlook for Teleflex from a growth perspective is solid. I think our 6% long-range plan, we can see definitely line of sight to get there. I think that the environment is rich. We have some parts of our business really performing well. We mentioned OEM. We mentioned Interventional Access. Surgical had a really good start to the year. Interventional Urology at 6.1%. And then geographically, you see EMEA coming in at 9.7% and double-digit growth in APAC. So I will say that the underlying growth algorithm for Teleflex is very much intact. And as we head into -- and we're 1 quarter into the second year of our LRP, and we feel pretty bullish about the outlook for our company.
Operator:
Your next question comes from the line of Larry Biegelsen from Wells Fargo.
Unknown Analyst:
This is Nathan Treybeck on for Larry. Can you talk about, given the constant currency beat in Q1, what were some of the considerations for not raising the full year guide?
Liam Kelly:
Yes. So obviously, the first consideration is it is Q1, and I think if you take that into account. The other consideration is we give our guide in February, we had a really, really nice March. So that was helpful. And we came in above where we thought based on the performance of March and some of the performances that we spoke about earlier on.
And we did have some OEM orders that pulled in from Q2 into Q1, and we updated for FX. So we'll continue to monitor the situation as we go into Q2, Q3 and Q4. But again, I feel fairly bullish on our performance. This is our fifth quarter in a row where we've actually been in a position to beat our internal revenue forecast and to be able to provide upside. And it's a nice upside of $11 million. Again, a few million was pulled in from orders from OEM that shipped in Q1 rather than Q2. But other than that, the underlying growth of the business is really solid.
Unknown Analyst:
Okay. And can you talk about like the drivers of growth for Palette. Is it share gains? Is it market expansion? If you could just give some color there.
Liam Kelly:
Yes. The bulk of the growth for Palette is really market expansion. We have continued to bring this product to our existing customer base, and it's being adopted there I mean there is some share shift, but I would say that we are more focused on the white space than trying to take share from others within the marketplace. The product is performing exceptionally well. The sales force is very, very bullish.
Once we have our additional 50 reps trained, they will now be active in the marketplace in Q3 jewel bag selling that product. So that should also help. And also in order to expand the market even further, we have initiated and agreed and funded an additional study for expanded indications for the Barrigel product for Palette. We have identified the sites that will conduct the study and we envision beginning enrollment in the very near future. So not alone, we're not satisfied with the market of 330-odd million dollars. We want to expand that market even further so that we can create more white space for us to grow into.
Operator:
Your next question comes from the line of Matthew O'Brien from Piper Sandler.
Matthew O'Brien:
Tom or Liam, I know you're going to say it's Q1 and everything, but you just beat Q1 by about $0.15 or $0.14 on the bottom line, only taking the low end up by about a nickel. So the midpoint is only going up by about $0.025. Why the conservatism there, especially with inflationary pressures easing? And could we just start looking at kind of the higher end of that range just based on the trends so far?
Thomas Powell:
Well, I would just say, first of all, we raised by $0.09 in the lower end, but $0.05 or I should say, $0.04 of that was offset by an increase in the foreign exchange rates. So again, we feel really good about the results in the first quarter. We've provided full year guidance.
Gives us improved confidence in our ability to achieve that full year guidance, and we'll continue to monitor the situation and update. But again, we are just getting out of the first quarter and give us a chance to see a little bit more how the year is playing out.
Matthew O'Brien:
Okay. Fair enough. And I wanted to ask about UroLift, but I think the more pertinent questions back on Interventional, like Jason was talking about. That performance has been very strong for several quarters in a row here. You've got this focus on structural heart. It's one of the fastest growth areas in med tech. You've got Wattson coming.
Is this an area that can deliver not necessarily this level of growth, but just well above Teleflex levels of growth for the next several years? And is this an area of focus maybe from an M&A perspective as well, just given the strong underlying performance of the market in general?
Liam Kelly:
So I'll start with the last part of your question. It's definitely a focus for M&A, Matt. I've said many times that I like the cath lab as a call point. We now have a global franchise with that call point. And it is one of the key areas of focus for us when we're doing M&A. It's not the only area of focus, but it's a key area of focus.
With regard to the sustainability of the growth, I think that the Interventional portfolio that we have with MANTA in there with Wattson coming in there, we got Ringer coming down the road. We got Triumph that's going to be launched sometime in 2025. So we have a whole suite of products coming into this call point. And we have invested heavily in the R&D organization there to ensure that we have the suite of products coming through. So I think it's well capable of maintaining well above Teleflex average growth and be a growth driver for Teleflex over a multiyear period just based on that background, but it has come at the back of investment. This is one of our areas where we have invested behind and the acquisition of MANTA a number of years ago is playing out really well as we penetrate that large bore closure market.
Operator:
Your next question comes from the line of Anthony Petrone from Mizuho Financial Group.
Anthony Petrone:
And I hope everyone is doing well congrats on a strong 1Q here. Maybe a couple of questions. One, just actually focused in on the Americas. Surprised to see just regionally, Americas actually being down a touch here. And then when you sort of bridge that to some of the divisions Vascular was pretty good, OEM obviously outperformed even Interventional Urology is touch ahead of our numbers. So where specifically in the U.S., was there slippage? Was it tough comps? Or was there other stocking dynamics in the U.S.? And I'll have 1 follow-up.
Liam Kelly:
Yes, Anthony, thank you. I hope you're keeping well as well. Thanks for the question. With regard to the Americas, the biggest impact there, Anthony, was the MSA. If you'll recall, all of the MSA was booked in the Americas. So if you backed out the MSA from that, your growth would have been around 3.5% for the Americas, if you took the MSA out.
The underlying -- there's a few underlying things I want to point out in the Americas as you go through the year, the Endurance recall mostly impacted -- and that's in vascular, that mostly impacted the Americas. So as you get through Q2 and into Q3, you will have anniversaried that. And then if you look into the Q4, we will also anniversary the MSA. So you will see an improving environment for the Americas as you go through the year. But please do bear in mind that MSA, Anthony, it's all booked in the Americas and it's all coming out of the Americas on a year-over-year basis, and that's really the drag on that one. And you had a follow-up, Anthony.
Anthony Petrone:
Yes. One quick follow-up would just be a high-level revisit on the M&A strategy here at Teleflex and the company has been active over the years, and it's done a number of different transactions. I remember the years of the distributor tuck-ins. There have been some R&D plays but not as prevalent as the sort of here and now revenue-generating growth accretive deals. And of course, the EBITDA level is now higher. And so maybe just to revisit on the strategy what is most prioritized and what are the size of transactions that you're contemplating these days?
Liam Kelly:
So I think that for Teleflex, we're really focused on tuck-ins and scale transactions. We have done some late-stage technologies, and we've done some investments -- early-stage investments into companies, and we'll continue to do that. We have the most important thing you need, Anthony, for M&A, which is firepower.
So as Tom said in his prepared remarks, we're 1.7x levered. So we have lots of firepower. We are, at the moment, chasing lots of assets. I will tell you, and they do fit in the range from a tuck-in of revenue of, call it, in the tens of millions to scale transactions in the hundreds of millions. We are cognizant of dilution, especially in this year where the MSA going away the dilutive, you have Palette coming in this dilutive, the underlying earnings growth is in that 8% to 10%, as Tom outlined in his remarks, so -- but I think investors want to see that. So we are keeping that in mind. We are disciplined, Anthony, and we will remain disciplined. I think that finally, the multiples seem to have tempered somewhat at least some of the high-growth assets on the public markets are not carrying the value that they were 12 months ago. And obviously, that plays into the psyche of the seller as well. And it's obviously, as a buyer, you can point to really great companies on the public markets, super companies, but not carrying the value that they held 12 or 18 months ago, and that should be reflective in private companies as well. So a healthy environment, lots of assets and a very, very disciplined Teleflex.
Operator:
[Operator Instructions] Your next question comes from the line of Mike Polark from Wolfe Research.
Michael Polark:
I'm curious on this CLEAR trial that's reading out at AUA over the weekend, UroLift versus Rezum. What's reasonable to expect there? Is there an impact in the field you anticipate as the data is disclosed?
Liam Kelly:
Mike. Look, we have a lot of data coming out at the AUA. We have 5 different papers that are being read out and there are a number of other studies. One in particular that coming from the European group about early intervention on minimally invasive therapies and that's much better than having individuals on pharma.
With regard to the specific one that you're talking about, it's really focused on more rapid symptom relief and quality of life improvement posttreatment comparing UroLift to Rezum and outcomes that can aid health care providers and patients in getting a clearer understanding of the postoperative experience that the patient experiences with the product. I think there's a study on retreatment rates, which I'm really looking forward to hearing. I'm actually attending the conference myself. And also, there is a real-world study on complications of all BPH treatments, and I think that's going to be enlightening as well. So I think we've got a full suite of podium presence at the AUA. And I think that for sure, any of these head-to-head either comparing UroLift to Rezum, comparing it to other technologies, comparing it to drugs will be helpful for the sales force.
Michael Polark:
Appreciate that, Liam. If I may follow up on Urology as well on the numbers. I just want to make sure I'm understanding the performance in the quarter, the expectation for the year. So if I'm doing the math correct, I have net of pull at UroLift, maybe down high teens year-on-year.
And I think if I do the guidance for the full year, perhaps UroLift down 10%. And so I just want to understand:
One, for the first quarter, have I done the math correct? And you said that aligned with your internal plan, and I just want to make sure that, that's all fair; and then two, kind of the path for UroLift to be better over the course of the year. It sounds like the sales force no longer being retrained and out in the field, double bag probably is a piece of that. But anything else you might be able to offer as to kind of why we get that product line trending back up the rest of the year would be helpful.
Liam Kelly:
Yes, absolutely, Mike. We've discussed this on previous calls, we're not going to -- we're going to report on total Interventional Urology consistent with all of our global product categories and businesses and we're not going to provide product level revenue details for individual business lines or product categories within those.
We have 4 reportable segments, we had 6 product segments. So there's 10 ways to slice and dice Teleflex. But let me give you a little bit of color, having said that. Let me start with the full year, and then I'll go back to the quarter. For the full year, we are expecting -- and nothing has changed in our expectation for Interventional Urology. I am extremely confident of being able to deliver 7.5% growth in 2024 which was at the midpoint of our guidance. This includes revenue for Palette Life Sciences of $66 million to $68 million, offsetting the year-over-year declines in UroLift. Now in the quarter, Interventional Urology grew 6.1%. Palette came in, in line with our expectations and continues to perform very well. UroLift performance was also within our expectations. And as we expected, UroLift was impacted by the declines in the office side of the service, but also from the cross training. And your insights are correct, Mike. As we go through the year, that cross-training will be more or less completed for those 50 once you get into Q3 and beyond. So feel good about the 7.5% on a full year basis for the Interventional Urology business unit.
Operator:
Your next question comes from the line of Craig Bijou from Bank of America.
Craig Bijou:
Liam, I know you're not going to get into the specifics on '25, but street expectations for margin expansion have come down looking at '25. So maybe if you could just talk about some of the opportunities to expand margins in '25 and how those might be lining up maybe without actually given specifics, but just kind of talking about where you could see some improvement.
Liam Kelly:
Well, I think, Craig, it all starts with the gross margin line. And if you look at this year, at the midpoint, we're going to expand our gross margins by about 100 basis points. We've had a really good start to the year. Gross margins expanded 170 basis points in the first quarter of the year. So God rest my mother. She used to say, good start is half the battle, and we've had a really good start on the gross margin line.
As you look forward, we have a number of catalysts for the gross margin line to come into being. We continue to have continuous improvement programs within our global supply chain team. We'll have Palette, the MSA will be behind us when we get into 2025. Palette will be continuing to ramp when we get into 2025. So those 2 factors will obviously help our gross margins. And I believe we'll continue to have positive pricing in '25. So that mix and positive pricing, continuous improvement programs. And then for Palette specifically, you'll begin to get leverage to the op margin line where it becomes accretive to the op margin and we're a very disciplined company on our OpEx. So I do believe that it all begins and ends with the gross margin line and we -- and it will drop through to operating margin into the future. And I feel good about our prospects to continue to drive both growth and operating margin leverage on a solid 6% top line growth for Teleflex and underlying 10% EPS growth, which is pretty much what we're delivering this year.
Craig Bijou:
And if I could follow up on maybe some standard bariatrics and Titan. And as you expand the product offering there, just -- maybe you can just give us revisit kind of how to think about the contribution from Titan and standard bariatrics in '24 and going forward? And maybe what the new commercial updates or the new product expansion can do for growth?
Liam Kelly:
Yes. Thanks, Craig. So first of all, on the product expansion, having buttress is an important add-on to the Titan product. 60% of surgeons who do gastric sleeves use buttress. And technically, the Titan product doesn't need buttress because of the seal pressure and a very high burst pressure. But it's what they want to use.
So we have given them what they want to use, and it's been very well received by the bariatric community. I will tell you that in Q1, Titan came in, in line with our expectations. So that was good to start the year out in that regard. And I do still believe that it's going to be a contributor to growth this year and in future years. Just to give some color on what's happening with gastric sleeves on a macro level, I think investors would be interested in that. So in the second half of the year, we saw gastric sleeve procedures down 10% to 15%. So I think what that means for Teleflex is the market we're growing into is a little bit smaller potentially than the $250 million plus that we outlined to that. But at the end of the day, it's still a big market to grow into with lots of opportunity for us to penetrate the Titan product into that gastric sleeve market. Sorry, I just want to add one other thing, Craig. We -- again, in the quarter, we had a robust proctoring and training of surgeons in the quarter. My apologies to cut you across you, operator.
Operator:
Your next question comes from the line of Richard Newitter from Truist Securities.
Unknown Analyst:
It's actually Sam on for Rich here. Just first one from us on 2Q, I think $760 million to $765 million a touch below Street there. Some of that's from FX, some of that's from the OEM pull forward. But just anything else that you would call out in 2Q sort of explaining the delta between Street and the guidance?
Liam Kelly:
No. They are the 2 big buckets, Sam. There's about $6 million of FX in Q2 and also there's a few million of OEM products that were originally planned to be shipped in Q2. Just bear in mind that the MSA was slightly higher in Q2, that's something just to bear in mind. And as we go through the year, you've got that dynamic of the MSA, and you also have the dynamic of Palette ramping as you go through the year. So you've hit on the 2 main impacts on Q2. $760 million, $765 million, 3.7%, and we feel good in our ability to deliver that.
Unknown Analyst:
Great. And then just on Palette. I know try to avoid, given the product specific that you given us the $66 million to $68 million. Just curious what you'd be looking for in the market or in results to take that range up and what could give you confidence there.
Liam Kelly:
Yes, Sam. So it started very well. That's the first thing I would say. The second thing I would say, there's a lot of enthusiasm for the product. The third thing I would say, the expanding of the indications is a key strategy for us, not for this year, but in outer years to continue to grow that.
And that will be a unique indication that no other spacing technology will be able to address. I think that the product -- the fact that you can actually -- the product is very visible. The fact that you can mold the product, the fact that you don't have to rush with the product is really -- landing really well with both the radiation oncology community and the urology community. So we'll get another quarter or 2 tucked under our belt, Sam, and then we'll come back to the investment community with our thoughts on the $66 million to $68 million. But as I sit here today, feel really good about the $66 million to $68 million.
Operator:
And your next question comes from the line of Kristen Stewart from CL King.
Kristen Stewart:
I just wanted to touch on the Vascular Access business that came in a little bit lighter than what I was expecting. Can you maybe just comment on the performance there in the quarter and what we should expect for the balance of the year?
Liam Kelly:
Yes, Kristen, that's a good observation and a good question. The Endurance recall impacted the vascular business in Q1, and we'll anniversary that as we go through Q2. So when you get into Q3, you'll have a clean look at Vascular. So you should see vascular improve as you go through the year.
The other thing I would say on the Vascular business, the underlying PICC growth was really solid, but that will improve too as we go through the year. I would anticipate seeing PICC volumes pick up as we go through the year. The underlying CVC growth is really solid and we're really happy with how that's performing. So all in all, it's really the Endurance anniversarying that and an improved environment for PICCs continuing to grow as you go through the year.
Operator:
And that concludes our Q&A session for today. I would like to hand back over to Lawrence Keusch for closing remarks.
Lawrence Keusch:
Thank you, Polly, and thank you to everyone that joined us on the call today. This concludes the Teleflex Incorporated First Quarter 2024 Earnings Conference Call.
Operator:
Thank you for joining us. You may now disconnect your lines.
Operator:
Good morning, ladies and gentlemen, and welcome to the Teleflex Fourth Quarter 2023 Earnings Conference Call. At this time, all participants have been placed in a listen-only mode. At the end of the company's prepared remarks, we will conduct a question-and-answer session. Please note that this conference call is being recorded and will be available on the company's website for replay shortly. Now, I will turn the call over to Mr. Lawrence Keusch, Vice President of Investor Relations and Strategy Development.
Lawrence Keusch:
Good morning, everyone, and welcome to the Teleflex Incorporated fourth quarter 2023 earnings conference call. The press release and slides to accompany this call are available on our website at teleflex.com. As a reminder, a replay will be available on our website. And for those wishing to access the replay you can refer to our press release from this morning for details. Participating on today's call are Liam Kelly, Chairman, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks and then we will open the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements, regarding future events as outlined in the slides posted to the Investor Relations section of the Teleflex website. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. Now, I'll turn the call over to Liam for his remarks.
Liam Kelly:
Thank you, Larry, and good morning, everyone. On this morning's call, we will discuss the fourth quarter results, provide some commercial updates and introduce our financial guidance for 2024. We had a solid finish to 2023 as momentum seen through the year continued into the fourth quarter. For the quarter, Teleflex revenues were $773.9 million a year-over-year increase of 2.1% and an increase of 0.7% on a constant currency basis. As a reminder to investors, there were 5 fewer shipping days year-over-year in the fourth quarter. The shipping day impact in the quarter was an estimated $57 million or approximately a 7.4 percentage point reduction in constant currency growth year-over-year. When adjusting for the shipping day impact, the implied constant currency growth was 8.1% year-over-year. Fourth quarter adjusted earnings per share was $3.38 a 4% decrease year-over-year. During the quarter, utilization continued to return towards normal seasonality. From a macro perspective, we witnessed a stable to improving environment for material inflation and supply chain. These dynamics generally track to our expectations for the full year. For the full year 2023, we had a strong performance with revenues reaching $2.975 billion, which represents 6.5% constant currency growth year-over-year, while adjusted earnings per share was $13.52. As we look to 2024, we anticipate a stable procedure environment with seasonality in line with pre-pandemic levels. Although the Teleflex portfolio is not likely to benefit from pent-up demand due to the focus on critical care procedures, we would anticipate that staffing will continue to see improvements during the year. Supply chain dynamics largely stabilized through 2023, and we expect to see continued improvements in 2024. Teleflex has broad global manufacturing capabilities and we continue to assess vertical integration opportunities to gain further control of our supply chain. Turning to inflation. There were elements of improvement during 2023, including sea freight and raw materials. For 2024, we are assuming some further disinflation, but note that costs remain somewhat elevated relative to historic levels and are above 2023. Now let's turn to a deeper dive into our fourth quarter revenue results. I will begin with a review of our geographic segment revenues for the fourth quarter. All growth rates that I refer to are on a constant currency basis and reflect the negative impact of 5 fewer shipping days year-over-year, unless otherwise noted. Americas revenues were $450.6 million, a 1.9% decrease year-over-year, driven by Surgical and Vascular and reflective of the 5 fewer shipping days in the quarter. In particular, we saw year-over-year growth in our Interventional Anesthesia and Interventional Urology businesses despite the fewer shipping days in the quarter. EMEA revenues of $152.4 million decreased 2.7% year-over-year, driven by Anesthesia and Surgical and reflective of the impact of the fewer shipping days. Urology products, Interventional and Vascular businesses generated the highest shipping days adjusted growth in the quarter. Turning to Asia. Revenues were $88.3 million, increasing 12.6% year-over-year. Revenue growth was broad-based across the region, with strong double-digit increases in Korea, India and China. The performance in the quarter was driven by strong commercial execution and solid underlying demand. Let's now move to a discussion on our fourth quarter revenue by global product category. Commentary on global product category growth for the fourth quarter will also be on a year-over-year constant currency basis and reflects the impact of the 5 fewer shipping days. On a shipping days adjusted basis, the sequential growth in the fourth quarter trended in line with our expectations with Vascular and Anesthesia growth rates improving, while Interventional and Surgical slowed. Starting with Vascular Access. Revenue decreased 1.2% to $186.7 million. Along with the fewer shipping days, the year-over-year growth also reflected the impact of the previously announced Endurance catheter recall. The quarter was led by year-over-year growth for EZ-IO and other access despite headwinds from the fewer shipping days. Of note, we achieved double-digit growth in our underlying PICC business when excluding the negative impact of the Endurance recall. We continue to see opportunities for share gains in the peripheral access markets and our new product initiatives will help play a role. During the quarter, we continued to execute on our launch activities for our next-generation navigation device and new PICC stylets. Moving to Interventional. Revenue was $135.6 million, up 7.2% year-over-year. Despite the impact of the fewer selling days, we demonstrated solid growth, which underscores our positive momentum as we continue to make good progress with our growth drivers. Turning to Anesthesia. Revenue declined 3.4% year-over-year to $98.2 million. Among our larger product categories, hemostatic products performed well in the quarter, with strong double-digit growth, partially offset by declines in atomization and ET Tubes, as we recover from the recall, which occurred earlier in 2023. In our Surgical business, revenue was $109.6 million, down 2% year-over-year against a tough comparison. Our underlying trends in our core surgical franchise continue to be solid, including our ligation portfolio. For 2023, Titan generated revenues in excess of $12 million. For International Urology, revenue was $93 million, representing an increase of 4.2%, starting with Palette, which we acquired in October 2023. Revenues in the fourth quarter were modestly better than expectations with outperformance of Barrigel. For UroLift, the office remains a challenge as we continue our efforts to stabilize this size of service. In the international markets, UroLift revenue saw a healthy growth in Japan, while in China, our initial launch activities remain on plan with a focus on training surgeons and gaining reimbursement. OEM had another solid quarter, with revenues increasing 10.9% year-over-year to $82.6 million. The strength in the quarter was broad-based across our portfolio, with all product categories recording year-over-year growth, including continued strength in microcatheters. Fourth quarter Other revenue declined 10.2% to $68.2 million year-over-year. As previously disclosed, fourth quarter Other revenues reflects the early December 2023 exit of the MSA by Medline and accounted for the majority of the year-over-year revenue decline. That completes my comments on the fourth quarter revenue performance. Turning to some commercial and clinical updates. Following the acquisition of Palette Life Sciences on October 10, 2023, I am pleased to report that the integration is tracking to our expectations. We have completed and issued cross-functional product sales training for selected members of our legacy UroLift sales force, and our dual-bag reps are now interacting with clinicians in the field. Our focus remains on expanding the use of rectal spacing in the treatment of prostate cancer, and we are engaging with urologists and radiation oncologists. Barrigel is a differentiated rectal spacer that is clinically proven to significantly reduce unwanted radiation exposure. Moving to UroLift. We continue to expand our foundation of clinical data that supports the use of UroLift as a safe and effective minimally invasive treatment for BPH. In November 2023, we highlighted a new peer review study in the Nature Journal, Prostate Cancer and Prosthetic Diseases, that reinforces the position of the UroLift system as the goal standard in minimally invasive surgical treatment for BPH. Results suggested that within 1 year of BPH surgery, 1 in 20 patients may require retreatment regardless of whether they receive a TURP, GreenLight, Rezum or UroLift. Additionally, at 1 year, procedural complications requiring a return procedure in the outpatient setting was lowest following UroLift and highest following Rezum. The average time to the first complication was the longest for UroLift. At 5 years, retreatment was lowest for TERP and statistically similar between GreenLight and UroLift. The retreatment rate for UroLift is comparable to publish controlled trial rates, thereby underscoring the durability of the UroLift system. We continue to focus on supporting UroLift with clinical data, and note that we have 8 sponsored research abstracts that have been accepted for presentation at major urological meetings in 2024. Turning to an update related to our surgical business unit. We have completed the launch activities for the Gore Seamguard Bioabsorbable staple line reinforcement material to be used with the Titan Stapler. The ability to offer synthetic buttressing material alongside the unique features of the Titan Stapler should enable Teleflex to further address surgeon clinical needs and preferences in the sleeve gastrectomy market. Lastly, as we look into 2024, we will continue to advance our new product introductions with a number of launches across our business units. In our interventional business, we expect to receive FDA marketing clearance and launch the Ringer Catheter in the second half of 2024. Ringer incorporates a unique balloon design that allows blood to flow through a vessel while the balloon is inflated. We will initially launch with a PTCA indication, but we have completed enrollment in a vessel perforation trial that will be utilized to seek FDA label expansion. In our surgical business, we anticipate launching new ligation products, including an automated polymer clip applier in the second half of 2024. We will also continue to refresh our laryngoscope families with a series of launches during the year. Our anesthesia business unit is also on track for new product launches, including updated technology in our EZ-IO business that would enable expansion of our user base, for which we expect FDA approval in 2024. We will provide more details upon launch. That completes my prepared remarks. Now, I would like to turn the call over to Tom for a more detailed review of our fourth quarter financial results. Tom?
Thomas Powell :
Thanks, Liam, and good morning. Given the previous discussion of the company's revenue performance, I'll begin with margins. For the quarter, adjusted gross margin was 60.1%, a 10 basis point increase versus the prior year period. The year-over-year increase was primarily due to favorable price, benefits from cost improvement initiatives, lower logistics and distribution-related costs and the Palette acquisition, partially offset by continued cost inflation and unfavorable fluctuations in foreign exchange rates. Adjusted operating margin was 26.3% in the fourth quarter. The 160 basis point year-over-year decrease was primarily driven by the inclusion of Palette Life Sciences operating expenses, employee-related expenses and investments to grow the business, partially offset by the flow-through of the year-over-year increase in gross margin. Net interest expense totaled $22.5 million in the fourth quarter, an increase from $18.7 million in the prior year period. The year-over-year increase in net interest expense reflects higher interest rates versus the prior year and higher average debt outstanding utilized to fund the acquisition of Palette, partially offset by increased interest income. Our adjusted tax rate for the fourth quarter of 2023 was 11.6% compared to 13.6% in the prior year period. The year-over-year decrease in our adjusted tax rate is primarily due to an increase in tax deductions as a result of additional amortization of R&D costs, which as a result of the U.S. tax law change, resulted in capitalization of such costs starting in 2022. At the bottom line, fourth quarter adjusted earnings per share was $3.38, a decrease of 4% versus prior year. The year-over-year decrease in EPS reflects dilution from the acquisition of Palette Life Sciences and the related incremental borrowings. Turning now to select balance sheet and cash flow highlights. Cash flow from operations for the 12 months was $511.7 million compared to $342.8 million in the prior year period. The $168.9 million increase was primarily attributable to lower tax payments, favorable changes in working capital and favorable operating results. The favorable changes in working capital were primarily driven by lower inventory purchases stemming from the buildup of inventory in the prior year due to elevated global supply chain volatility. Moving to the balance sheet. At the end of the fourth quarter, our cash balance was $222.8 million as compared to $292 million as of the end of 2022. For the 12 months, the decrease in cash is primarily due to payments to fund the Palette acquisition, partially offset by net proceeds from borrowings and operating cash flow. Net leverage at quarter end was approximately 1.9x. Inclusive of the acquisition of Palette Life Sciences, our financial position remains sound and continues to provide us flexibility to execute on our long-term capital allocation strategy. Turning now to financial guidance. Starting with a couple of discrete items for 2024. First, we continue to expect the Palette acquisition to be $0.35 dilutive to the company's adjusted earnings per share in 2024. Beginning in fiscal year 2025, the transaction is expected to be increasingly accretive to adjusted EPS. Second, as previously disclosed, the manufacturing transition services agreement with Medline associated with our sale of certain respiratory assets included in December 2023. Of note, Teleflex generated $75.7 million in revenues from the MSA in 2023, which will not repeat to 2024. Moving to our outlook for 2024. We are expecting 2024 constant currency revenue growth of 3.75% to 4.75%. The year-over-year growth includes the loss of the $75.7 million in MSA revenues, partly offset by the incremental revenues from Palette. Turning to foreign exchange. We assume approximately $5 million or 15 basis points headwind to revenue from foreign exchange translation in 2024. Our outlook for foreign exchange includes a euro to dollar exchange rate of approximately $1.08. Netting the loss of MSA revenues, the incremental Palette sales and foreign exchange headwinds represents an approximately 100 basis point year-over-year headwind to growth in 2024. Considering the foreign exchange outlook, we expect reported revenue growth of 3.6% to 4.6% in 2024, implying a dollar range of $3.082 billion to $3.111 billion. Turning to margins. We expect 2024 gross margin to be in the range of 60% to 60.75%. Our gross margin guidance reflects the year-over-year positive impacts from the termination of the MSA, manufacturing efficiencies, rights and the Palette acquisition, partially offset by inflation and the impact of changes in foreign currency exchange rates. We expect operating margin to be in the range of 26.25% to 26.75% for 2024. Our guidance reflects the flow-through of gross margin and the positive impact of restructuring, offset by the inclusion of operating expenses for Palette Life Sciences and investments to grow the business. Moving to items below the line. Net interest expense is expected to approximate $78 million for 2024. The majority of the year-over-year increase in our net interest expense outlook reflects the impact of borrowings associated with the Palette acquisition, partially offset by planned debt repayments during 2024. Our tax rate is expected to be approximately 12% for 2024, which reflects favorable mix offset by discrete items in 2023 that will not repeat in 2024, and the impact of Pillar 2 global minimum tax. We estimate the impact of Pillar 2 to add approximately 150 basis points to the 2024 tax rate. Turning to earnings. We expect 2024 adjusted earnings per share be in a range of $13.55 to $13.95. Our adjusted EPS outlook reflects $0.35 of dilution from the acquisition of Palette, $0.26 of dilution from the termination of the MSA and a $0.23 headwind associated with the year-over-year increase in our tax rate, primarily due to the Pillar 2 minimum tax. Relative to foreign exchange, although there is a negligible impact on revenue, the headwind to earnings per share is approximately $0.24 year-over-year. Based on current foreign exchange rates, we expect roughly half of the headwind to EPS to fall into the first quarter of 2024. When adjusting for these items, including the negative impact of foreign exchange, the underlying adjusted constant currency EPS growth is approximately 7% at the low end of guidance and 10% at the high end of guidance. Although we do not provide quarterly guidance for your modeling purposes, we expect reported revenues for the first quarter to be in a range of $725 million to $730 million, including a negligible foreign exchange impact year-over-year. That concludes my prepared remarks. I would now like to turn it back to Liam for closing commentary.
Liam Kelly :
Thanks, Tom. In closing, I will highlight our 3 key takeaways from the fourth quarter of 2023. First, we delivered on our financial commitments for 2023. For the year, constant currency revenues increased 6.5% and adjusted earnings per share were $13.52. Compared to our initial 2023 guidance, constant currency revenue growth exceeded our guidance, while adjusted earnings per share was at the high end of our range. Our execution remains strong. We are launching new products and our margins remain healthy. Second, the fourth quarter performance and stable to improving macro environment provides a solid foundation for growth as we head into 2024. Third, we will continue to focus on our strategy to drive durable growth. We will invest in organic growth opportunities and drive innovation over time, expand our margins and execute on our disciplined capital allocation strategy to enhance long-term value creation. The integration of Palette is progressing well and we expect the acquisition to be a meaningful contributor to our growth in the coming years. That concludes my prepared remarks. Now I would like to turn the call back to the operator for Q&A.
Operator:
[Operator Instructions] Our first question comes from the line of Patrick Wood with Morgan Stanley.
Patrick Wood :
I guess the first one Palette, we will talk a lot about Barrigel understandably as the bulk of the business. But you obviously acquired with that a number of other urology assets that are a little bit smaller. And that combined with obviously UroLift and Barrigel, you've got a bit of a platform that you're kind of building up on that side of things. So my question is essentially like how much interest is that for you guys longer term in scaling up in that market overall, just given it's quite a fragmented industry and there's quite a lot of interest in different areas? Is that something that's kind of crossed your minds? Or is it you kind of now done with urology to your mind?
Liam Kelly :
UroLift in 2017. We knew the urology call point very well because of our surgical business. There isn't a radical prostatectomy done in the world that doesn't use 1 of our surgical products. We built on that with the Palette acquisition. The main product in there is the Barrigel for rectal spacing. It's performed beyond our expectations in the first quarter of ownership. And that momentum, we'll carry that on. We will integrate Palette before we do anything else in the urology space, but urology is definitely an early area of interest to us, Patrick, in particular, men's health. There are areas within men's health that are open for disruption. There are some parts of men's health that haven't had innovation or new technologies in a number of years, similar to the fact that there had been no disruption to BPH until UroLift came on to the market. So we think there are areas for disruption within men's health, and it is an area of focus for us, probably not in the next 6 months, Patrick to be fair, as we integrate Palette into Teleflex. But thereafter, our balance sheet, as you know, is in great shape. So we would see that as a definite area of expansion for Teleflex.
Patrick Wood :
And then as a quick follow-up, you've obviously got a lot of product launches moving through '24. You have things that are moving from dilutive to accretive, the inflation environment is getting a little bit better. There's things that are moving considerably in your direction as we move through '24. Is that environment part of what gives you confidence around the '25 LRP? Not to jump the shock, but is that big picture why you still feel very confident in that?
Liam Kelly :
Yes. I feel really good about the LRP. If you start with the revenue, in our first year, we did 6.5%. Obviously, our guide this year is 3.75% to 4.75% but with a 100 basis point headwind. So the underlying growth that we're expecting this year is 4.75% to 5.75% adjusting for those headwinds. And as we head into the second year of the LRP, I feel confident in our ability to deliver the current guidance and that will be the springboard into next year, the final year of the LRP. For me, it's all about execution. I think we executed really well in 2023. And my goal is to continue to execute as we did in 2023 through 2024 at a minimum each quarter, achieving and hopefully beating our goals as we migrate through the year. And then on the margins, I think we've -- we're going to take a step up again this year in gross margins. And it will be tougher for us to get to the up margin goal in all transparency and I think the investment community know that. We've had more inflation than we've thought and we brought in a great asset in Palette, but that asset brought some OpEx. But we still think they are the right numbers for us and we feel we have a path to get there.
Operator:
Our next question comes from the line of Jayson Bedford with Raymond James.
Jayson Bedford :
Maybe just on gross margin. The fourth quarter was strong. I wanted to ask about the '24 guide. You did what 59.5% in '23. I thought the MSA adds 100 basis points, and then you have Palette, you have a bigger revenue base. So I guess, my question is, is the gross margin headwind all on the FX side? Or are there any new pressures that you're contemplating here?
Thomas Powell :
Well, to your point, we get a nice benefit in 2024 from both the acquisition of Palette and from the exit from the MSA. So those are both accretive to gross margin. What I would say is that we've got a number of headwinds, as Liam had mentioned, inflation is still higher than it had been pre-pandemic. And if you look at the total of our favorable pricing, savings from manufacturing, cost improvements, savings from footprint programs, they're able to offset those inflationary pressures as well as some capitalized balances that are on the balance sheet and will rollout in the P&L in 2024. So those are kind of a wash. In addition to the inflation headwinds, we're also experiencing a modest adverse impact from foreign exchange.
Jayson Bedford :
And then just maybe to pile on the last line of questioning. On the urology selling effort, have you seen any selling synergies between Barrigel and UroLift? And can we assume that there's nothing baked into the guide?
Liam Kelly :
Jason, you can definitely assume there's nothing baked into the guide. I will tell you that for UroLift, we saw a modest improvement in Q4 versus Q3. So we're monitoring that pretty closely. We still expect $66 million to $68 million for Palette. We still expect Interventional Urology will deliver approximately 7.5% revenue growth at the midpoint. The low point of our guide assumes that it will grow just a little bit above 7%. The -- and the midpoint also assumes there's no improvement on UroLift from quarter 3. And the reason we use quarter 3, it's the most recent quarter without a days impact our seasonality. They have a tough comp in Q1 right out of the gate. But after that, I would expect that they would continue to show some improvement as we go through the year. But I think that the guidance -- our entire guidance, I believe, is appropriately prudent, Jayson. And I think -- as I said earlier, our goal is to execute against that as we go through the year. And as a team, I think we feel really confident in our ability to deliver on all aspects of it.
Operator:
Our next question comes from the line of Shagun Singh with RBC Capital Markets.
Shagun Singh :
I just wanted to touch on the 2024 guidance. You're calling for about 5% to 6% growth adjusted for the onetime headwind tailwinds that you called out. And I believe delivering about 1.5x EPS growth relative to sales growth. Why the conservatism, especially on the top line, given the strong exit in 2024 -- sorry, 2023? And then I have a follow-up.
Liam Kelly :
So look, we're really happy with where we landed at the end of 2023 in quarter 4. If you adjust for the days, we delivered a robust 8.1% growth in the fourth quarter. And in the entire year, we delivered 6.5%. I will say, Shagun, that if you look at the low point of our guide this year at 3.75%, and you add back that percent to get you to 4.75%, it's the exact same starting point at the low point as we had last year. I think that the guide is prudent. I think the guide sets us up so that we can execute as we go through the year. And I think that it allows us, as we go through the year as a company to do what we did in 2023, and that has always been our goal. Now there are a couple of moving pieces within the guide, Shagun, from the different business units I would expect APAC OEM and IA and surgical to take a modest step back. Surgical because they'll anniversaried the Titan acquisition. And then I would expect a modest step forward in growth rate for EMEA, Interventional Urology, Vascular and Anesthesia. And I think that I feel as I said, good about the way we've guided and I feel good about our ability to deliver.
Shagun Singh :
And then just on M&A, Liam, can you provide us your updated thinking there and especially how you're thinking about short-term P&L dilution relative to top line accretive M&A? And any interest in adjacencies?
Liam Kelly :
I think, as I say always, the most important thing you need when you're doing M&A is firepower and we have that. We're 1.9x levered, which gives us lots of ability without raising our leverage too much. We are conscious of dilution. Our investors have given us feedback that in 2024, unfortunately, always doing the right thing by Teleflex, but 2 things hitting in the 1 year has caused a lot of dilution. And as Tom walked you through the bridge, our underlying earnings per share growth is really strong -- is really positive. But you obviously have the MSA, which is causing some dilution there. And also you have Palette causing some dilution in FX. And you add all of those up, and the midpoint of our growth is -- or the range of our growth is 7% to 10% if you excluded those. So we are cognizant of that. We are out there in the marketplace looking at assets. Our M&A team is busy and there are attractive assets in the marketplace that we believe would fit well within the Teleflex family and we will continue to execute that with the thought to investor feedback on dilution.
Operator:
Our next question comes from the line of Matt Taylor with Jefferies.
Michael Sarcone :
This is Mike Sarcone on for Matt. Just a first 1 on guidance. Understanding that you provided 1Q, which is helpful. Do you think you can elaborate a little more on phasing through the year? I know you mentioned kind of seasonality consistent with pre-COVID levels, but we've got a bunch of moving pieces, particularly big shifts or swings in selling days in the 2023 base period. So any more color you can provide on how you're thinking about phasing through the year?
Liam Kelly :
Yes. So I think that the low point of the year would be quarter 1, and then you would see improvement as you go through the remainder of the year from the revenue side and it would be fairly consistent after quarter 1. And the reason that the quarter 1 is a little bit dampened is, as I said, there's a few tough comps in the mix there. But we would envision that once you get through to Q1, you would get back to a more normalized seasonality with quarter 4, the biggest of the year, just due to the normal seasonality and patients getting more procedures done in quarter 4, and this has been a phenomenon for a number of years now since Obamacare came into being. So that would be our expectation on the revenue line.
Michael Sarcone :
Just a quick follow-up there. When you see improvement in sales each year. Do you think 3Q could be above 2Q in terms of sales dollars?
Liam Kelly :
No, I'm talking in general that once you get through the low point of Q1 that Q2, Q3 and Q4 would be above Q1, with Q4 always being the biggest quarter from a revenue perspective just due to that normal seasonality. Mike, the point I was trying to make is that Q1 would be the low point.
Operator:
Our next question comes from the line of Larry Biegelsen with Wells Fargo.
Larry Biegelsen :
Liam, what was price in 2023? And what are your expectations for ‘24? And I have 1 follow-up.
Liam Kelly :
We had a good year with price in 2023, we exceeded our goal of 50 basis points and came in above that. Our goal for 2024 is to deliver another 50 basis points, and I'd be hopeful that this is the third year of the pricing cycle, so I'd be hopeful that we'd be able to at least deliver that 50 basis points again.
Larry Biegelsen :
I appreciate it. I know you just guided to 2024. I appreciate your comments about the operating margin, LRP being a bit challenging for '25. So I guess my question is, is the 7% to 10% underlying EPS growth in 2024 the right way to think about '25? And are there any moving pieces to consider like interest expense, which I would imagine would come down from that $78 million and could be a nice tailwind for you? Any just high-level thoughts beyond '24.
Liam Kelly :
I mean the reason that we're calling out the underlying earnings per share is because underlying that's what the business is doing. And therefore, we do believe that our business is well capable of driving that high single digits into the double digits. And I think even though the up margin targets will be a challenge. I just still think that they're doable for the business, but when will we get there? If we don't get there in 2025, then get there shortly thereafter. I might ask Tom just to give a bit of color on the interest, Tom, if you don't mind.
Thomas Powell :
Sure. Well, just also talking about EPS and what will play well into 2025 is the fact that we've got some dilution in 2024 from the MSA going away, and that will be in the run rate by 2025. And then same thing with Palette, our expectation is that Palette turns to profitability by 2025. So those will be benefits. We're also seeing inflation coming down kind of in the marketplace, but just the way it flows through our inventory, it takes some time to clear the P&L. So if trends continue on the inflation front, we should see improving benefits by 2025 in that area. Then with regard to interest, right now, our expectation is that we will be using free cash flow in 2024 to continue to pay down some of our prepayable debt, so that will reduce our debt outstanding each quarter of the year. And then we also, in our guidance, we're assuming 325 basis point rate cut. So you should see an improving interest environment -- interest expense environment as we go through the year and into 2025.
Operator:
Our next question comes from the line of Matthew O'Brien with Piper Sandler.
Matthew O'Brien :
Just clarification upfront to make it clear for everybody on the call, 5.25% at the midpoint is the constant currency growth rate assumption, when everything is adjusted, 8.5% is the midpoint for the bottom line when everything is adjusted. I just want to make sure that's fully clear.
Liam Kelly :
Yes, I think your math is good, Matt, as always. Those would be the adjusted top line and bottom line midpoints. Thanks you for clarifying that. That's good of you.
Matthew O'Brien :
So the Q1 guide actually was better than I was expecting because the comps are so tough, and I understand Palette is there this year, but the rest of the business would have to be doing well across Vascular, International. I don't know if there's extra selling days, but I'd just love to hear a little bit about the comfort on the outlook for Q1 specifically. And then I think it implies actually an acceleration into your stack growth over the remainder of the year. So again, I don't know if that's new products, et cetera, but we'd just love to hear about that. And then I do have 1 quick follow-up.
Liam Kelly :
So our guide would assume if I want to put it into percent, it would assume that roughly 2% to 3% for Q1 growth, underlying would be 3.5% to 4.2% normalized for the MSA and FX and the other moving pieces. As I said earlier, we would be a wee bit lighter just because of the tough comp, and also, you'd have the Palette ramp as you go through the year. Vascular will be a little bit lighter in the first quarter just due to the recall. And to your point, the new product ramps in particular in vascular is important this year as we go through the year. We've launched a number of new products into the PICC franchise and as they ramp through the year. Regarding our degree of confidence in hitting the first quarter, we're -- towards the back end of February, Matt and we as a team would feel confident in our ability to deliver in that first quarter number. And as I said, we've done 4 for 4. All of '23, we at least reached, if not exceeded our revenue and EPS for 4 quarters in a row. And as a team, we're united in the fact that we're not going to be happy until we go 5 for 5, 6 for 6 and ultimately 8 for 8 and then reset the goal into the following year, and that's what we're planning to do.
Matthew O'Brien :
And then just to Larry's question on just some of these headwinds on the EPS side that you're facing this year. I don't suspect there's a lot of upside to Palette or the MSAs this year, but it would seem like you're positioned for a meaningful snapback in terms of EPS growth next year. Just -- and something even in the kind of low to mid-teens kind of EPS growth, is that -- am I way off base in thinking that just given all these headwinds that you're facing this year?
Liam Kelly :
I'll tell you, Matt, I'd appreciate if you'd be a little bit patient with that as we execute through '24 before we start guiding to '25. But we would anticipate -- look, I'll go back to the underlying. The underlying EPS growth, if you exclude the headwinds is good and solid. And as Tom went through, you have a few factors that will help then on top of that such as Palette and interest and so on and so forth. So we'll guide to '25 a little bit later in the year, Matt, if you don't mind.
Operator:
Our next question comes from the line of Mike Polark with Wolfe Research.
Mike Polark :
Liam in your prepared comment, you mentioned you're continuing to assess vertical integration opportunities to gain further control of your supply chain. I'm curious what that means. Is that an interest in doing more M&A in the OEM space? Or is that just a comment on, we're looking at any and all ways to be better on sourcing and supply chain?
Liam Kelly :
So it's more of the latter, Mike. What we discovered out the other side of the pandemic and as supply chain disruption hit was that if it was within our control, we were able to manage it an awful lot better than when we were reliant on third-party vendors. And there are some subcomponents that we feel we have the ability to bring in-house over time. So it's really looking at subcomponent suppliers within our supply chain. It would help our margins, that's a given as we bring it in and that's obviously an attractive element to it as well. But it's the latter to your question.
Mike Polark :
The follow-up, an item on the GAAP to non-GAAP reconciliation for 2024. There's a pension charge, $2.85. It's not an insignificant number, $150 million, if I had the math correct. What's going on there? Is that a cash item? Or is that a non-cash item?
Thomas Powell :
It's a non-cash item. So we essentially are exiting 1 of our pension plans where we fully funded and offered pensioners a buyout option and then we'll -- whoever it didn't take the buyout option, we'll go and put an annuity in place for them. So essentially, we're just exiting a pension plan, but it's non-cash.
Operator:
Our next question comes from the line of Richard Newitter with Tourist Securities.
Lin Zhang :
It's Lin Zhang on for Mike. So I'm just wondering what assumptions around the [inaudible] growth incorporated in the guide? And also appreciate you share your expectation of the Palette that’s the path [inaudible].
Liam Kelly:
I'm sorry, the line is incredibly bad and we're having great difficulty hearing you.
Lin Zhang :
Your assumption around direct growth you've incorporated in the guide.
Liam Kelly :
Yes. Thank you. I apologize, we couldn't hear you that well. So the Titan Stapler, we do assume that it will grow in 2024, not at the levels we thought that when we acquired it in all transparency. We now have the impact of the GLP-1s or a good portion of the impact of GLP-1s in our run rate as we went through 2023. And our expectation is that it will return to growth or continue to grow, I should say, in 2024. We are continuing to proctor surgeons. The product is performing exceptionally well. No issues with the Titan product itself. And now with the launch of Buttress, 60% surgeons will use buttress. Technically, our product doesn't need it, but it's how surgeons do the procedure, and therefore, having buttress will give us access to greater parts of the market. And our proctoring in -- as recently as January was well in line with our expectations and we continue to bring on new surgeons.
Lin Zhang :
And also another 1 for me. So you just shared your expectation of slice that back in OEM growth. So how should we think about the size of the step back? Should we still think consider OEM as like low double-digit grower?
Liam Kelly :
Well, I think that it's going to take -- I pointed as a modest step back. So it grew around 18% or 19% last year. So it will come back into the double-digit area and as we continue to execute. So low double-digits isn't a bad starting point. But just bear in mind that those modest step backs will be offset by step-ups in businesses like Vascular, like Anesthesia and also geographically like EMEA.
Operator:
Our next question comes from the line of Anthony Petrone with Mizuho Securities.
Anthony Petrone :
Nice underlying print here. Maybe, Liam, just starting with -- just procedure volumes. We've been seeing a lot from the managed care companies on MLR losses talking about procedures running hot. We've seen it across a few of the prints. I think the underlying, excluding days here for Teleflex also shows that. So maybe just the state of the union on procedure volumes specific to the U.S., and then I'll have 1 OUS geographic question as a follow-up.
Liam Kelly :
Yes. Sure, Anthony. So what we are seeing is solid procedure volumes in the acute hospital. We continue to see that. We're back to pre-pandemic levels. I think we're executing well against it. We're also benefiting from a plethora of new product launches. And those product launches will continue into 2024, and help even augment what we're seeing from a procedural point of view within the hospital. So it's a very positive environment in the acute care hospital. And we -- as you know, Anthony, we really like that space.
Anthony Petrone :
And then pivoting to China, we're still hearing different things about VBP, different programs that are coming out at various provincial levels. So maybe do you have any update from the Teleflex standpoint on China VBP? And more of a broader question and I don't think this has really come up on a lot of conference calls, but everyone's so doggedly focused on VBP near term. But should we be modeling medium-term net that China is just a down pricing market over the next 3 to 5 years just given where things are geopolitically?
Liam Kelly :
Yes. So there are a series of provinces coming together and running volume-based procurement tenders. I think we're gone through the phase of the national tenders, and now you have amalgamations of provinces. We saw that in 2023, and we participated in some of those in 2023. While that was happening, China continued to be a real solid double-digit grower for Teleflex. So we have strategies around volume-based procurement. And I think that for Teleflex, we only sell the most unique of our products in China. We sell very, very little of our Anesthesia portfolio there. We sell practically nothing of our Drainage Urology portfolio in China. Our main businesses there are in our coated CVCs, our Interventional business and our Surgical business. And there will be an impact from VBP. But because of our differentiation of our products, the discount levels are a little bit less for Teleflex, and they're being offset by volume. And as you know, had positive pricing as a company. So we're more than capable of managing what's going on within China with certain of our strategies around volume-based procurement. So I'm still positive on China as a geography for Teleflex as a company. And I think that it's one that will provide growth in the longer term for the company.
Operator:
Our next question comes from the line of Craig Bijou with the Bank of America.
Craig Bijou :
I want to start with the high-growth product bucket. And what was growth in '23? How to think about expectations for growth in '24 and '25? And I think Tom made a comment about investments to grow. So maybe more broadly, how do you think about your need to invest behind some of these high-growth products and considering the margin impact?
Liam Kelly:
Yes. So high-growth products portfolio performed very well in 2023. There were some really standout contributions, I'm thinking particularly of the intraosseous the hemostatic portfolio. MANTA really continues to penetrate that market. If you look forward into the high-growth for 2024, we would expect the high-growth to grow in the region of 10% to 11.5%, 12-ish percent somewhere around there. We would expect the durable core to do a little bit better again this year than it did last year in the 5% to 6% range. But obviously, the offset is in the other category because of the MSA, and that's going to decline in or around that 30-ish percent. Regarding the investment behind it, it's easier to invest behind the high-growth, Craig, in all transparency just because it is much better margin. So you get the drop-through op margin from the growth even with the additional investment. And our focus of our investment has always been and this has been for the last number of years, behind those high-growth buckets because of the margin profile and the benefit that it brings to mix within our income statement.
Craig Bijou :
And if I can ask a follow-up on UroLift. The office business you highlighted that's still seeing some challenges in the U.S. What about the other sites of service in the U.S.? And then on Japan, just how do we think about the launch there in the longer-term or medium-term expectations for growth?
Liam Kelly :
I'll start with Japan, and then I'll talk about the sites of service. So Japan is doing exceptionally well. It's really in line with our expectations. What we told investors Japan would do. Japan is doing. The team there is executing very well. Also geographically, we're very early in Taiwan and India, and we're ramping in those geographies. They're smaller, for sure, and we're very early days in China. We continue to work on China, getting the product listed in the public system and the inflection point for China will be 2025 once we start to get listed in more of the products. With regard to the sites of service, we again grew in the hospital site of service in Q4, but it's again, the office, unfortunately, is still challenging for us just because of the reimbursement change that was made there.
Operator:
Our next question comes from the line of Kristen Stewart with C.L. King.
Kristen Stewart :
The Interventional business grew very nicely in this quarter and 15% for the full year on a constant currency basis. You'd mentioned MANTA was continuing to do very well there. Can you just expand upon what's driving that growth and how sustainable you feel it is going into 2024?
Liam Kelly :
Yes, Kristen. So it's 1 of the areas that will take a modest step back. And as I said earlier, it will be offset by the other businesses that will take a step forward. I mean that's why we're a portfolio company at the end of the day because you have these ebbs and flows. And they'll have a tough comp. MANTA will have a tough comp next year. It will continue to grow, but it will have that aspect. We continue to see really nice growth in the pump business. The competitor that was off the market was back in Q3, they're back in Q4. But notwithstanding that we continue to execute well there. And the lifeblood of this business unit is new products. We have a really good cadence of new products. We launched the GuideLiner Coast last year. We've got the Ringer coming as we go through the year. And over the next number of years, we have a really nice suite of products going into the hands of this sales force. So I'm really happy with how the Interventional business is going well. Obviously, the intraosseous on control is within there. That continues to perform very well, had a really solid quarter 4 as well to help drive the growth.
Kristen Stewart :
I just want to make sure I understand your comments around '25 and the LRP. So it sounds like you feel pretty confident about being able to hit the gross margin line, but operating margins are going to be tougher to achieve that forecast. Is that correct?
Liam Kelly :
Yes, that's what I was saying, Kristen. I mean, I think we could get there and we have a potential path to get there. Will we get there by the end of '25? It's tougher to get there by the end of '25. We really get there. It just might take a wee bit longer. And again, definitely solid path to the revenue and the solid path to the gross margin line and underlying EPS as we've gone through with a couple of your colleagues underlying EPS is solid.
Operator:
Our final question comes from the line of Mike Matson with Needham & Company.
Mike Matson :
Just wanted to ask on Palette with Barrigel. I know obviously, there's a big opportunity within prostate that you're going after. But I think you've talked about potential to expand into other types of cancer. So can you talk about the timing there and whether or not you have to do trials to get those indications?
Liam Kelly :
We are expanding the indication. It is within our model. We will have to do clinical trials in order to get there. We have begun mapping out and enrolling the investigators that would help us with that. And obviously, as we build the relationship with radiation oncologists, they would be a key part of that as well as urologists in order to get this expanded indication. I don't want to go into details on the call, Mike about Palette indication because we -- as you're very aware in the city you live in, we have competitors.
Mike Matson :
And then just on you are within China, I know you talked about the size there, and obviously, there's a ton of people there. But can you just talk about kind of the competitive landscape? And then I'm not even sure whether this is something that's covered by government payers, insurance or is it something that's out of pocket for these BPH treatments there?
Liam Kelly :
Yes. So the landscape is similar to where it is everywhere else in so far is that Tarp is the main procedure that is used on men within China. The nuance in China is that they don't tend to be as pharma focused in so far as that they will try other herbal remedies within that. But you're right, it's such a huge population. The way it works within China is your first step is to get it listed on all of the regional tenders. So we're going through that process now in Shanghai and Beijing, in those 2 big provinces. That would be an obvious place to start. And then thereafter, you apply for reimbursement. The reimbursement never covers in any procedure of the total cost of the procedure, Mike, there's always some out-of-pocket and the general population in China is used to have to pay out-of-pocket when they go to a hospital.
Operator:
I would now like to turn the call over to Mr. Lawrence Keusch for closing remarks.
Lawrence Keusch:
Thank you, [Mandeep] and thank you to everyone that joined us on the call today. This concludes the Teleflex Incorporated fourth quarter 2023 earnings conference call.
Operator:
That is all the time we have for questions this morning. Our conference for today is now concluded. Thank you all for your participation.
Operator:
Good morning, ladies and gentlemen, and welcome to the Teleflex Third Quarter 2023 Earnings Conference Call. At this time, all participants have been placed in a listen-only mode. At the end of the company’s prepared remarks, we will conduct a question-and-answer session. Please note that this conference call is being recorded and will be available on the company’s website for replay shortly. And, now, I will turn the call over to Mr. Lawrence Keusch, Vice President of Investor Relations and Strategy Development. Please go ahead.
Lawrence Keusch:
Good morning, everyone, and welcome to the Teleflex Incorporated third quarter 2023 earnings conference call. The press release and slides to accompany this call are available on our website at teleflex.com. Please note that webcast viewers have the ability to advance the presentation slides on their own, simply follow along with the presentation as we proceed through the call. As a reminder, a replay will be available on our website. Those wishing to access the replay can refer to our press release from this morning for details. Participating on today’s call are Liam Kelly, Chairman, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks, and then we will open the call to Q&A. Before we begin, I’d like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in the slides posted to the Investor Relations section of the Teleflex website. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. Now, I’ll turn the call over to Liam for his remarks.
Liam Kelly:
Thank you, Larry; and good morning, everyone. It is a pleasure to speak with you today. On this morning’s call, we will discuss the third quarter results, our acquisition of Palette Life Sciences, and our financial guidance for 2023. Turning to the third quarter. Teleflex revenues were $746.4 million, a year-over-year increase of 8.7% and an increase of 7.4% on a constant currency basis. Third quarter adjusted earnings per share was $3.64, an 11.3% increase year-over-year. During the third quarter, we experienced stable to improving macro and healthcare utilization trends. In the acute care setting, which is our primary market, utilization during the third quarter returned towards normal seasonality. From a macro perspective, we witnessed a stable to improving environment for material inflation and supply chain in the third quarter on a sequential basis. These dynamics are generally tracking to our expectations for the year. Now, let’s turn to a deeper dive into our third quarter revenue results. I will begin with a review of our geographic segment revenues for the third quarter. All growth rates that I refer to are on a constant currency basis, unless otherwise noted. Americas revenues were $428.2 million, which represents 5.5% growth year-over-year. In particular, we saw strong performance in our Surgical and Interventional businesses. EMEA revenues of $142.7 million, increased 4% year-over-year. During the quarter, Interventional led the growth, while we saw balanced performance across our other businesses. Now, turning to Asia. Revenues were $93.2 million, increasing 17.1% year-over-year. During the third quarter, we saw stable demand across the majority of the region. Revenues in China increased in excess of 20% year-over-year and reflected solid underlying demand. Given our specific portfolio of products, we have not seen any impact on our business in China as a result of government-initiated anticorruption measures. Let’s now move to the discussion of our third quarter revenues by global product category. Commentary on global product category growth for the third quarter would also be on a constant currency basis. Starting with Vascular Access. Revenue increased 0.3% to $169.9 million. As expected, the quarter was negatively impacted by the previously announced Endurance catheter recall. Initial launch activities for our next-generation Arrow VPS Rhythm DLX navigation device and the new Arrow PICC pre-loaded with the NaviCurve Stylet continue to generate a positive customer response and system placements. And we drove double-digit growth in our underlying PICC business. Moving to Interventional Access. Revenue was $134.1 million, up 22.4% year-over-year. In the quarter, we continue to drive our complex PCI and emerging structural heart portfolios. Balloon pumps, access enclosure, uncontrolled and MANTA were meaningful contributors to growth in the quarter. Turning to Anesthesia. Revenue declined 1.3% year-over-year to $97.6 million. As expected, the previously announced ET Tube recall negatively impacted year-over-year growth. In our Surgical business, revenue was $112.8 million, up 20.6% year-over-year. Among our larger franchises, ligation, staplers and instruments were notable drivers of growth. For 2023, we now expect Standard Bariatrics’ Titan Stapler revenues in the teens. For Interventional Urology, revenue was $73.6 million, representing a decrease of 6.8% year-over-year. In the U.S., the office remains the biggest challenge for UroLift. We are continuing our efforts to stabilize this side of service. In the international markets, we remain focused on driving UroLift revenue in Japan, while in China our initial launch activities have tracked to plan. OEM had another solid quarter with revenues increasing 14% year-over-year to $82.3 million. The strength in the quarter was broad-based across our portfolio, including microcatheters. Third quarter Other revenue increased 5.3% to $76.1 million year-over-year. As it relates to the Other revenues, we have been informed by Medline that they are now in a position to exit the MSA earlier in 2023 than previously anticipated. We now expect the MSA to cease earlier in December rather than December 31st. Tom will give an update on the financial impact later in the call. That completes my comments on the third quarter revenue performance. Turning to some other business updates. On October 10th, we announced the close of the acquisition of privately held Palette Life Sciences for an upfront cash payment of $600 million at closing and up to an additional $50 million upon the achievement of certain commercial milestones. Palette’s product portfolio, particularly Barrigel, will complement the UroLift system, covering the top two diseases within urology care, BPH and prostate cancer. Barrigel is a differentiated rectal spacer. The product is easily sculpted when placed between the prostate and rectum and allows the physician to achieve predictable protection of healthy rectal tissue prior to radiation therapy. There is a large and growing global market for rectal spacers. The American Cancer Society estimates that there will be 288,000 new cases of prostate cancer in the U.S. with the incidents growing 3% a year. In addition, the increasing use of hypofractionation radiation therapy is driving demand for rectal spaces to protect healthy tissue. From a strategic perspective, the addition of Palette’s portfolio complements our strong presence in the treatment of benign prostate enlargement and helps to expand the clinical landscape of our interventional urology business. Of note, urologists perform the majority of rectal space replacements, which will leverage our existing call point. We have a broad and established urology sales organization, which will be augmented by Palette’s clinical expertise in the use of rectal spacing for radiation therapy in prostate cancer treatment. The acquisition will also enable Teleflex to engage with other specialists in areas including radiation oncology, female urology and pediatric urology. We will implement strong peer-to-peer education, a patient awareness focus and leverage best practices. We also expect interest in rectal spaces to provide opportunities to cross-sell UroLift, although such synergies have not been included in our acquisition model. Finally, Barrigel has established brand success, which allows Teleflex to effectively invest in and grow within a significant new market. From a financial perspective, we expect the acquisition to be immediately accretive to revenue growth and adjusted gross margin and enhance our adjusted operating margin in the near term. Moving to the topic of GLP-1 drugs, which has been an investor focus over the past couple of quarters. We continue to evaluate clinical data and monitor the usage of GLP-1s to assess potential exposure for Teleflex. We have reviewed the markets that we serve. And, at this time, we do not expect GLP-1 to have a significant direct impact on Teleflex’s diversified product portfolio. Although our largest exposure is Standard Bariatrics with the Titan Stapler, revenues for this product are expected to account for less than 1% of Teleflex’s overall revenue in 2023. Over the past two quarters, we have seen an impact on sleeve gastrectomy volumes from the interest in GLP-1s. It is important to note that while the SELECT trial showed a 20% reduction in major adverse cardiac events over five years, a recent study from the Cleveland Clinic, which was presented at the American Society for Metabolic and Bariatric Surgery 2023 Annual Scientific Meeting showed that bariatric surgery has been associated with a 42% lower risk of major adverse cardiac events. While we continue to expect some softness to bariatric surgery volumes, we believe we will offset this due to our focus on capturing market share. We remain active in gaining back approvals and training surgeons during the quarter. We’ve also done a deep dive into our interventional business to assess the possible impact of GLP-1s in light of the results in the SELECT study, which showed an absolute reduction in the rate of major adverse cardiac events of 1.6% from approximately 8% to 6.4% over five years. When considering the types of events defined in MACE for the study and the follow-up period, the reduction in these events on an annual basis is measured in the tens of basis points. So, actually, a relatively small impact. In addition, when considering that GLP-1 patients could live longer, it may only serve to delay cardiac events. Also, demographics remain a powerful driver with global populations aging. Accordingly, we do not expect GLP-1s to have a significant impact on our Interventional business. More broadly, we sell other surgical products to bariatric surgeons, including metal ligation clips and closure devices. But the revenue associated with these projects in this surgical specialty is immaterial to Teleflex. Indeed, the vast majority of our surgical products are utilized in general, cardiac, urology and gynecological surgeries and are not expected to be significantly impacted by GLP-1 usage. Teleflex also sells hemodialysis catheters through our vascular and interventional business units. In total, hemodialysis catheter sales in North America account for less than 1% of Teleflex revenues, with the majority utilized for the treatment of acute kidney injury, or AKI, which is not expected to be impacted by GLP-1 use. It is estimated that AKI develops in up to 67% of patients admitted to the intensive care unit with the vast majority not associated with chronic kidney disease. Common causes of AKI in hospitalized patients include severe infection, low blood pressure and blockages of the renal tract, and it is often reversible. Between the businesses mentioned as well as assumptions for other discrete product categories, total sales for products that have potential direct exposure to increased use of GLP-1 drugs is approximately 1% to 2% of Teleflex revenues. That said, the potential impact should be less than that as the use of GLP-1 drugs may reduce some usage but would be unlikely to completely eliminate the need for our products exposed. Our highly diversified product portfolio is primarily focused on critical carrier procedures. And, as a result, we estimate that over 98% of Teleflex revenues should not be directly impacted as a result of increased usage of GLP-1 drugs. We will continue to evaluate clinical data and monitor the usage of GLP-1s to assess potential exposure to Teleflex moving forward. Moving to an update on our Interventional Access business. We are pleased to share that we are in the final stages of completion for the commercial launch of Wattson Temporary Pacing guidewire. Wattson is a unique bipolar guidewire used specifically for TAVR and BAV procedures and engineers to help reduce the risk of ventricular perforation while providing confidence in capture during rapid pacing. As a dual delivery guidewire and pacing wire, Wattson will complement our expanding structure and heart portfolio, which already includes demand in large foreclosure device, and the Langston Dual Lumen for contrast delivery and pressure measurement. We are building momentum with a focus on complex PCI in structural heart. Of note, we continue to drive our innovation engine, and we’ll be launching a number of new products over the coming years. That completes my prepared remarks. Now, I would like to turn the call over to Tom for a more detailed review of our third quarter financial results. Tom?
Thomas Powell:
Thanks, Liam, and good morning. Given the previous discussion of the company’s revenue performance, I’ll begin with margins. For the quarter, adjusted gross margin was 59.4%, a 70 basis point increase versus the prior year period. The year-over-year increase was primarily due to favorable price, benefits from cost improvement initiatives and lower logistics and distribution-related costs, partially offset by continued cost inflation and unfavorable fluctuations in foreign exchange rates. Adjusted operating margin was 27.2% in the third quarter. The 30 basis point year-over-year increase was the result of the flow-through of gross margin, partially offset by increased headcount and employee-related expenses, investments to grow the business and the inclusion of Standard Bariatrics operating expenses. Net interest expense totaled $15.7 million in the third quarter, an increase from $13.2 million in the prior year period. The year-over-year increase in net interest expense reflects higher interest rates versus the prior year and higher average debt outstanding utilized to fund the acquisition of Palette, partly offset by increased interest income. Our adjusted tax rate for the third quarter of 2023 was 8% compared to 9.8% in the prior year period. The year-over-year decrease in our adjusted tax rate is primarily due to a reduction in tax costs resulting from a US tax law requiring the capitalization of R&D expenses. At the bottom line, third quarter adjusted earnings per share was $3.64, an increase of 11.3% versus prior year. Turning now to select balance sheet and cash flow highlights. Cash flow from operations for the nine months was $372.4 million compared to $244.4 million in the prior year period. The $128 million increase was primarily attributable to favorable operating results, lower tax payments and favorable changes in working capital. The favorable changes in working capital were primarily driven by lower inventory purchases stemming from the buildup in inventory in the prior year due to elevated global supply chain volatility. Moving to the balance sheet. Inclusive of the acquisition of Palette Life Sciences, our financial position remains sound and continues to provide us flexibility to execute on our disciplined capital allocation strategy. At the end of the third quarter, our cash balance was $881.5 million as compared to $292 million as of the end of 2022. The increase in cash is primarily due to $600 million of cash on the balance sheet to fund the Palette Life Sciences acquisition in October 2023. Net leverage at quarter end was approximately 1.4 times, which remains well below our 4.5 times covenant. On a pro forma basis, third quarter net leverage with Palette was approximately 2.1 times. Now, turning to financial guidance. Starting with the acquisition of Palette Life Sciences, which closed on October 10th, and ahead of our December 1st assumption. For the full year of 2023, we continue to expect Palette net revenue to be approximately $56 million on a stand-alone basis. We now expect the transaction to be approximately $0.25 dilutive to the company’s adjusted earnings per share in 2023 versus dilution of $0.15 previously. The incremental solution in 2023 is primarily the result of higher interest expense as well as incremental operating expenses associated with the earlier close of the transaction. For 2024, there is no change to our expectation for Palette to achieve year-over-year net revenue growth in the high-teens or low 20% range. In addition, we continue to expect the transaction will be $0.35 dilutive to the company’s adjusted earnings per share in 2024. Beginning in fiscal year 2025, the transaction is expected to be increasingly accretive to adjusted EPS. Turning to an update on the manufacturing transition services agreement with Medline associated with our sale of certain respiratory assets. We have been notified by Medline that they intend to end the MSA earlier in our previous expected end date of December 31, 2023. Our revised 2023 constant currency revenue guidance now reflects a loss of approximately $4 million in sales due to the early termination of the MSA as compared to our prior guidance. Moving to our updated outlook for 2023. We are increasing our 2023 constant currency revenue guidance to 6.4% to 6.6%, representing a 90 basis point increase at the low end of the range and a 35 basis point increase at the high end of the range. It is important to note that the lost revenues from the unanticipated early termination of the MSA in 2023 offset a little less than half the incremental revenue associated with the earlier-than-anticipated close of the Palette acquisition, implying the majority of the increase in constant currency guidance was driven by the strong operational performance in the third quarter and our positive outlook for the fourth quarter. Turning to foreign exchange. We now assume approximately $4 million or 15 basis points headwind to revenue from foreign exchange in 2023. This compares to our prior guidance, which assumes an approximately $8 million tailwind to GAAP revenue growth in 2023. Our revised foreign exchange guidance for 2023 captures the actual rates for the third quarter and now assumes current foreign exchange rates, including a euro-dollar exchange rate of $1.05 for the fourth quarter. Considering the revised foreign exchange outlook, we expect reported revenue growth of 6.25% to 6.45% in 2023, implying a dollar range of $2,966 million to $2,971 million. Turning to margins. We are raising 2023 gross margin guidance by 25 basis points at the low and high end of the range to 59.25% to 59.75%. Given the earlier than expected close of the Palette acquisition and the associated incremental operating expenses, we now anticipate operating margin in the range of 26.25% to 26.5% for 2023. Below the line, we now expect net interest expense to approximate $76 million in 2023. The slight decrease in 2023 guidance reflects higher net interest expense associated with the earlier-than-anticipated close of the Palette acquisition, offset by outperformance in the third quarter and debt pay down in the fourth quarter. Our tax rate is now expected to be approximately 10% for 2023. We are narrowing our 2023 guidance for adjusted earnings per share to a range of $13.30 to $13.50. Our adjusted EPS outlook has been updated to reflect favorable operating performance, including better-than-expected results in the third quarter, partly offset by an incremental $0.10 of dilution from the acquisition of Palette due to the early close and approximately $0.05 from changes in foreign exchange rates versus the prior guidance and the earlier-than-expected termination of the MSA. Although we do not provide quarterly guidance, for your modeling purposes, we expect reported revenues for the fourth quarter to be in a range of $765 million to $771 million, which includes the impact of five less selling days, representing approximately $53 million, partially offset by foreign exchange benefit of $3.6 million year-over-year. And that concludes my prepared remarks. I would like to now turn it back to Liam for closing commentary.
Liam Kelly:
Thank you, Tom. In closing, I will highlight our three key takeaways from the third quarter of 2023. First, our diversified portfolio and global footprint drove durable growth in the third quarter. Our execution remains strong. We are launching new products, and our margins remain healthy. Second, the strong third quarter performance and stable to improving macro environment keeps us well positioned to deliver on our updated financial guidance for 2023. As we look to close out the year, we are positioned for better than 6% constant currency growth under our revised 2023 guidance. Third, we will continue to focus on our strategy to drive durable growth. We will invest in organic growth opportunities and drive innovation, expand our margins and execute on our disciplined capital allocation strategy to enhance long-term value creation. We are excited about the close of the Palette acquisition. We believe that the acquisition will be a meaningful contributor to our growth in the coming years, be immediately accretive to adjusted gross margin and will enhance our adjusted operating margin in the near term. That concludes my prepared remarks. Now, I would like to turn the call back to the operator for Q&A.
Operator:
Thank you. [Operator Instructions] And your first question comes from the line of Patrick Wood with Morgan Stanley. Your line is open.
Patrick Wood:
Amazing. Thank you so much for taking the question. I guess on the Interventional sort of things, I’m curious and maybe to some degree on Surgical. A, do you guys see any sort of a stocking benefit in the quarter, because it’s very strong numbers? And, B, was there any kind of benefit? Or are you seeing any kind of benefits? One of your peers obviously has a bit of a recall going on their side of the business on the balloon market. So, I’m just curious if you had any business doing a little bit better there? Thanks.
Liam Kelly:
Patrick, thank you very much for the question. Just taking a step back, I just want to start by saying that we’re really pleased with this quarter’s results, including Surgical and Interventional which outperformed. We feel, as a company, we deliver all aspects of our income statement in quarter three. Our updated guidance is bullish, and it reflects the three quarters to date performance and our confidence in a strong finish to the year. Many of our key franchises, including the ones you mentioned, are performing well. Healthcare utilization is back to pre-pandemic levels. And I think that the purpose for the acute care focus of our company is really paying dividends. Inflation in supply chain is stable to improving. And as we go through each quarter, we’re more confident in our ability to deliver. One of the only areas I’d say that we have not seen improvement is probably in the urology office side of service, which still remains a challenge. But with all that as the backdrop, we really feel confident in our updated revenue guidance of 6.4% to 6.6%, and our ability to achieve it. Specifically, to your questions on Interventional Access and Surgical, no, this was underlying growth driven by these businesses. We had outperformance in Interventional in our – some of our key product portfolios, including balloon pumps. And, in Surgical, also ligation stapling and also the instrument portfolio did very well. Regard to stocking, no, third quarter is traditionally a destocking month for distributors, and that’s what would have happened in this quarter as we would have expected. And regarding the company that has had a recall, they are now – they have come back to the market in fits and starts, and it’s a duopoly. So, normally, hospitals will focus on one company. They will either use our pump or their pump. And I think we may have seen some marginal benefit, but that really wasn’t – really what drove the upside in totality for the Interventional business. It was multifaceted across a broad range of the portfolio.
Patrick Wood:
Super clear. And thanks as well for the thoughtful GLP-1 commentary. That was really helpful.
Liam Kelly:
All right, Patrick.
Operator:
Your next question comes from the line of Jayson Bedford with Raymond James. Your line is open.
Jayson Bedford:
Good morning. I hate to start with a boring financial question, but maybe for Tom, what was the revenue and EPS impact of the recalls, both in Vascular Access and Anesthesia? And is there an impact on the fourth quarter?
Liam Kelly:
So, are you talking about revenue, Jayson?
Jayson Bedford:
Well, both. Was there a – I think, you mentioned there was a revenue impact in the third quarter. I’m just wondering if there’s a way to quantify that? And then was there an EPS impact of the recalls as well? I’m just wondering if that will recur in the fourth quarter.
Liam Kelly:
Yes. So if you added both of the recalls together, you would be looking in the quarter of a revenue impact of in or around that $5-ish million, Jayson, would be what it would be. If I think of the gross margin of both of the products impacted, you’re probably looking at just modestly below company average dropping through something around there. So, just less than 60% gross margin dropping through. So, you could figure out the EPS impact on that, I would say. You would agree, Tom?
Thomas Powell:
I would agree with the revenue impact. And then with the cost of the recall, we’re largely accrued in the second quarter of the year.
Liam Kelly:
That’s fair.
Thomas Powell:
Very minimal impact in the third quarter. Yes.
Jayson Bedford:
Okay. And then just more on UroLift. I know, it’s only been a month, but, Liam, are you seeing any cross-selling opportunities here between Palette and UroLift?
Liam Kelly:
So, we’re just in the very early stages of the integration and pulling the two companies together. There are a number of the sales team that are very welcome back to Teleflex that actually joined Palette. So, they already know the UroLift product. We have had a plethora of inquiries from our existing UroLift base asking us to trial the Palette Barrigel product, which is very, very encouraging. And it’s too early, Jayson, yet to see any impact of the cross-selling the other way from the Barrigel sales organization into the UroLift side of the house. And, again, as we said in our prepared remarks, we haven’t built that into our model, Jayson. Do we think that we will expect some? Yes, potentially, there will be a halo effect when you’re able to go into some urologists that in the past may not have considered UroLift as an option. But, as you know, 97% of urologists that do BPH also do prostate cancer. And of our base of urologists that use UroLift, only 20% of them are so use the Barrigel products. So, a lot of white space for us to grow into an early indications with the inbounds from our base is very encouraging.
Operator:
Your next question comes from the line of Shagun Singh with RBC. Your line is open.
Shagun Singh:
Great. Thank you so much for taking the question. I’m just trying to understand the underlying growth rate better here. For Q4, I think your ex-FX implies about 50 basis points of decline. I believe there’s a selling day headwind, which could be about 610 basis points. Palette is about 130 just based on our math, MSA maybe 50 basis points headwind, which gets us to 4.8% underlying versus 7.4% in Q3. So, firstly, is that math correct? It does imply deceleration from Q3 to Q4 on an underlying basis stacked two-year growth. Just wondering what is driving that? Is there some conservatism? And then what it implies for 2024 and LRP growth of low-6%? Sorry for all those numbers.
Liam Kelly:
No. That’s okay, Shagun, and thank you again for the question. So, I’ll go through a few pieces of it. So, our updated guidance is 6.4% to 6.6%. If you look at that on a constant currency basis, that’s 0.4% to 1.2%. Then, if you take into account the billing days that as you would have heard in Tom’s remarks, is $53 million or around 7%, that is an underlying growth of 7.4% to 8.1%. Then as you also heard from Tom, we’ve added in the Palette that closed earlier but also the MSA that leaves earlier. So, the MSA is approximately $4 million, and that is slightly shy of half of what we bring in from the Palette acquisition. So that’s how I would look at it. So, I would say that it’s not at all decelerating. If you take in today’s the account, the days – the lower end of our guidance into the Q4 would employ 7.4% to 7.4%, and the upper end would obviously show some acceleration. And, I think, as I said in my opening, that is truly, Shagun, a reflection of our performance through three quarters and our enthusiasm of what we see in front of us for the fourth quarter, I think, we’ve executed pretty well through three quarters. This is the third quarter in a row, we’ve been in a position to call up revenue. And I think we have a significant step up from the beginning of the year, and I just like to throw out one more number. At the beginning of the year, the low end of our guidance range was 4.75%. As we go now into the fourth quarter, the low end of our guidance range of 6.4%, a significant uptick.
Shagun Singh:
That’s really helpful. And then just as a follow-up on the margin side. You guys are absorbing about $0.25 of Palette dilution in 2023. You’ve raised your EPS guidance. So, what is driving this underlying improvement? And any color on 2024? I think, consensus looking for 50 basis points of margin expansion? And how should we think about 2024 in the context of your LRP? Thank you for taking the questions.
Thomas Powell:
Well, on the margin, what’s driving it is, largely, we’re seeing favorable results in pricing, mix and some manufacturing-related variances in the third quarter. As expected, inflation improves in the third quarter, both sequentially and year-over-year. Foreign exchange was a bit of a headwind in the quarter relatively – and, candidly, if you go back in time, it was actually a benefit earlier in the year has shifted to a headwind of sorts. So, those are some of the drivers that we saw in the third quarter, and we see continued improvement and stabilization in the macro environment, if you will, with regards to inflation and logistics costs and timing that we expect to play through into the fourth quarter as well. And then as it relates to margins for next year, we’re still working through our annual planning process and really aren’t in a position today to be providing guidance for next year at this point.
Operator:
Your next question comes from the line of Richard Newitter with Truist Securities. Your line is open.
Unidentified Analyst:
Hi. This is [Elaine] [ph] on for Rich. So, first question, I recall, last quarter, you kind of pinned on longer VAC Committee approval for Titan. Just wondering if it’s improving there? Or, like, any color you can provide on the trend there? Thanks.
Liam Kelly:
Yes. Absolutely. So, regarding Titan, first of all, just looking at Surgical in general, it had a – an absolute – really strong quarter, growing 20.6%. And with regards to Titan specifically, you will recall that from Q1 to Q2, we doubled the number of surgeons that we were proctoring in Q2 compared to Q1. I can tell you that in Q3, we maintained that level of proctoring. And that is a good indication that you’re getting through the value analysis committees, because you cannot proctor the surgeon until you’ve gotten through the value analysis committee. It’s taking longer than we anticipated originally, but now we’re into a reasonable cadence of getting through these value analysis committees. And it is our belief that while the Titan will be impacted and the market will be impacted by GLP-1s, as we said in our prepared remarks, that the technology is compelling, and we believe that there is a pathway to continue to take share. The product is performing very, very well. There are a number of clinical studies in process that will demonstrate the time efficiency of the Titan stapler compared to other technologies. And we do believe that it will be a growth driver for Teleflex over a multiyear period, given the ability that we have to save time for the surgeon to do a better procedure, to have better patient outcomes and, ultimately, we think that’s what will matter at the end of the day, and this will be a growth driver. Probably, the overall market won’t be as big as we initially thought, because of GLP-1s. That’s just a fact of life. But our objective here is to take share within the market space, and there’s still lots of room for us to grow into and take share.
Unidentified Analyst:
Great. That’s very helpful. Thank you. Also, on OEM, it appeared that it’s strong. So, do you have the confidence in this trend going into 2024? Thank you.
Liam Kelly:
Yes. So, our guidance would – is based on what we see through Q3, what we’ve seen in the first month of Q4, candidly. And of all of our businesses, the b`iness that we have the best line of sight is our OEM business, just because of the nature of orders are booked in advance and, therefore, gives us greater visibility into what’s happening within that business. I will tell you that the microcatheter part of OEM has continued to perform very, very well for the whole year and also within the third quarter. And we feel confident that the OEM business will continue to be a double-digit grower in – for the foreseeable future, just given the backdrop of some of the technologies that we have that are unique to Teleflex and some of the product development work that we’re doing in our innovation centers around the world with key customers.
Unidentified Analyst:
Thank you.
Operator:
Your next question comes from the line of Matt Taylor of Jefferies. Your line is open.
Mike Sarcone:
Good morning. This is Mike Sarcone on for Matt today. Thanks for taking the questions.
Thomas Powell:
Hi, Mike.
Mike Sarcone:
Hello. Just a follow-up on Standard Bariatrics, and thanks for all your commentary on the GLP-1 impact. Do you think you can give a little more color on the reduction you’re seeing in sleeve gastrectomy volumes? Any quantification would be helpful. And then just given that, what kind of share gain do you expect you need to at least offset the reduction versus your prior expectations for the volumes?
Liam Kelly:
So, it was a $300 million market roughly, Mike. So, who knows what the impact of GLP-1s will ultimately be. That’s got to be the starting point. I have a view that it’s obviously going to reduce sleeves in the nearer term. And it will depend if that is an air pocket depending on the outcomes, the longer-term outcomes of GLP-1s, how people bear with the side effects of GLP-1s. And don’t ever underestimate the cost. There’s a significant cost to these pharma options compared to a surgical option. And I know everybody is all heated up about the 20% reduction of major events in the SELECT study. Just to put that into context, as we said in our prepared remarks, that’s going from 8% to 1.6%. So, it’s a percent of a percent, which is a dangerous way to measure something as every analyst on this call will know, the true reduction is around 1.6% in absolute terms. And, as I said in my prepared remarks, the study that came out of the Cleveland Clinic showed a 40% reduction in the same events from gastric sleeves. So, I think, clinicians will start to take a step back and look at this on balance. What we are seeing is a reduction in the customers that we’ve converted for the number of procedures that they are doing for sure. But, as I said, it’s a – it was a $300 million market. What is it? A $200 million market now, plenty of opportunity, Mike, for us to grow into, because if you talk to most surgeons, they will tell you that this is the morbidly obese population we’re talking about that get a gastric sleeve. And I believe firmly that gastric sleeves, and if you talk to bariatric surgeons, gastric sleeves will exist in the future. And so, therefore, to grow into that, let’s call it, a $200 million market is still significant opportunity for Teleflex.
Mike Sarcone:
Great. Thanks, Liam. We’re on board with you in that kind of 10 to 20 bps per year impact. And just – my second question is just on the ASP pricing that you’re taking. Is it possible to quantify the level of price you’re taking and how sustainable that is or your thoughts about your ability to take price in 2024 and beyond?
Liam Kelly:
So yes, it’s a good question. I think we’re two years through the cycle now and most of our tenders and contracts go on a three-year cycle. So, through this year, we had laid out our plan to do 50 basis points. I can tell you we’re doing better than that. We’re a good bit north of that 50 basis points, similar to what we did last year. So, that’s a good story for us. And I think next year, we’ll be well in a position to do another 50 basis points, at least a positive pricing in the environment. After that, Mike, I think it will trail off a little bit, because we’ll have been through the cycle, the three-year cycle of your normal tenders, and we’ll assess that then in 2025.
Operator:
Your next question comes from the line of Larry Biegelsen with Wells Fargo. Your line is open.
Vik Chopra:
Hey. Good morning. This is Vik in for Larry. Thanks for taking the question. Two for me. The one on 2024, I just wanted to ask about the sustainability of the 10% tax rate given the recent changes in the tax laws? And my follow-up question is, on your M&A strategy, you recently closed the Palette deal, I’m just curious as to how much capacity you have left to do additional deals and how the higher interest rate environment is impacting your M&A strategy? Thank you.
Liam Kelly:
So, I’ll cover the M&A first, and then I’ll ask Tom to cover the tax question that you had, Vik. So, on the M&A, as we said in our prepared remarks, pro forma, we’re at 2.1 times levered. So, we have lots of firepower. Depending on what EBITDA the asset would bring, that would put you up towards the $2 billion mark of firepower available to Teleflex as we sit here today. Regarding the interest rate environment, interest rates were high at the time when we bought Palette, we’re still able to get to our internal cost of capital by year five. We still found a really attractive asset. We still found an asset that is going to continue the transformation of Teleflex. It’s going to augment our topline growth. It’s got really attractive margins as we’ve been through previously. And if you could find another Palette in the morning, I wouldn’t blink twice. I would be all in to execute on that. As I sit here today, we’re talking to more than a handful of companies. They range from anything from $100 million potential price to over $1 billion in potential purchase price. And I think the environment is still pretty attractive to companies like Teleflex who have the balance sheet to execute. Obviously, interest rates, we’ll remain disciplined. We’ve always remained disciplined through every cycle. When interest rates were low, we were disciplined; when interest rates are higher, we’re going to be disciplined. Nothing will change in that regard. And I’ll ask Tom to answer the question on the tax, if you don’t mind, Tom.
Thomas Powell:
Sure. So, our current 2023 tax rate of approximately 10% is a very attractive rate, I would say. And we’re currently in the process of working through the AOP and plans for next year. So, we’re not in a position to provide specific guidance for 2024 at this point. You know, I would say that the expectation would be that the tax rate would be modestly higher than where we are in 2023.
Operator:
Your next question comes from the line of George Sellers with Stephens Inc. Your line is open.
George Sellers:
Hey, good morning, and thanks for taking the question. For the Palette acquisition and specifically Barrigel, could you just give us some details on what that selling process looks like? And I think you mentioned that a majority of the users of Barrigel would be the urologist, but what’s the breakout more specifically from radiation oncologists versus urologists?
Liam Kelly:
Thanks, George, and good morning. So, we’re not ignoring the radiation oncologists, let me assure you of that. We have actually a dedicated team that are exclusively dedicated to the training of the rad onc as we go through this process. It’s around 70 plus percent of the procedures are done by the urologist as compared to the rad oncs, but we’re addressing both sides of service. I think, what’s important about Barrage is the uniqueness of the product, George. It’s sculptable, which means that you can actually then mold the product around the area you’re trying to protect and the most – for prostate you’re trying to protect the anus, so you’re able to mold it around the prostate to make sure that you’re getting protectability. There is no injectable time constraints. It’s highly visible. It’s a one-step assembly. It’s – you don’t have to do any hydrodissection. If you go into the wrong area, unfortunately, it happens from time to time with some of the products on the market, it’s reversible, which is unique to this particular product. And I think all of that makes it compelling. You’re right, and as I said earlier, it’s only 20% of our current UroLift customers that use Barrigel. So, for us, it’s really about expanding the market and growing the market rather than taking share. I think, this is a unique opportunity for Teleflex given our footprint in that area. The sales process, once a urologist or a rad onc comes forward, there’s a little bit of anatomy training, and then they’re proctored and helped over four or five cases. And after that point, then they would be deemed to be fully trained and qualified to place the product.
George Sellers:
Okay, great. That was a really helpful color. I appreciate it. And then maybe switching gears a little bit, maybe one on QuikClot. What inning would you say you’re in on penetrating that market opportunity? And have you seen any impact to demand from some of the conflicts going on internationally?
Liam Kelly:
So, it’s a $600 million market for internal and external split about half of each. We just got a new cardiac indication that expanded the market by about $50 million, George. So that takes us up to around $650 million market. MilTac in general is a key customer of ours. Because of some of the budgetary constraints, it has kind of been under our expectations through the first three quarters of the year. I would expect that that might rectify itself now though unfortunately, because of what’s going on in different parts of the world. So, we would imagine that that will get back to our original plan in the fourth quarter, and that’s anticipated within our guidance that we just outlined.
George Sellers:
Thank you for the time.
Liam Kelly:
All right, George.
Operator:
Your next question comes from the line of Anthony Petrone with Mizuho Group. Your line is open.
Anthony Petrone:
Thanks for getting us in here. Maybe, I’ll stick with Barrigel and actually ask also about pipeline as well. I know, you mentioned at the time of the transaction, $0.15 in 2023 and $0.35. I guess when we stack it up from a growth and margin perspective, is there anything you can share just on how Barrigel is growing? I know they have two other products in there as well, Deflux and Solesta in pediatric indications. What is the overall growth profile of the portfolio? And is it margin accretive to the overall corporate average? And then I’ll have a couple of follow-ups.
Liam Kelly:
Yes. Thanks, Anthony. So, what we expect in the full year from Palette is $56 million in 2023. The growth profile of it is high-teens and low-20s and that’s what we would expect in 2024. Regarding your question on the different components of the growth, I think you should focus very heavily on Barrigel. That’s where the majority of the growth is coming from. That’s where we bring a lot of the value and that’s where the growth has been – historically has been in the Barrigel product since it came on to the market just because of all the things I just went through a moment ago. Regarding the gross margins of the product, as we said previously, it’s accretive to Teleflex. Not alone is it accretive to Teleflex, but it’s accretive to the high-growth portfolio. And not alone is it accretive to the high-growth portfolio, it’s accretive to the UroLift margins within the high-growth portfolio. And as most investors would be familiar with, the gross margins of UroLift were in the high-70s or are in the high-70s, I should say. So, from a gross margin perspective, it’s a really nice transaction. And that’s candidly why it warranted a really nice price, because high growth, high margins is the formula for a higher multiple on an asset. And then we still expect $0.35 of dilution from an EPS perspective for 2024, to the other part of your question.
Anthony Petrone:
Okay. And then the follow-up would be, maybe I’ll go back to Titan and GLP-1. Of course, out of the gate here, a lot of folks are talking about headwinds to bariatrics in the near term, but there is chatter from folks in the space that when you think of the contraindicated patients at the very upper end of the BMI scale, some of those may be able to come into the fold as they take Ozempic or Mounjaro, et cetera, GLP-1. So, do you think as this cycle plays out that you could potentially see a tailwind, although, of course, it will take some time? What are your views on the potential for GLP-1 to actually expand the market in bariatrics? Thanks.
Liam Kelly:
So, my focus, honestly, Anthony, is not on the GLP-1s expanding the market, I find that hard to see in all honesty. I see GLP-1s being used as a conduit to a gastric sleeve and a lot of surgeons are looking at it in that way. And I’m also looking at it as it impacts on Titan as to how long-lasting it will be as an impact, because you have to take the pharma forever, and you have to be able to afford to take the pharma forever. Everything I’m reading is telling me that in – if the prices stay as where they are for these GLP-1s, that the likelihood of coverage is unlikely. And I’ve spoken to a number of bariatric surgeons, and I’ve spoken to the team, and I’ve spoken to our clinical group, and the perspective is that it is going to have a short-term impact on bariatric surgeries. But, as I said earlier, from a Teleflex perspective, at least for the next number of years, our goal is to bring a better technology to the gastric sleeve market, which none of us think is going away. It might be a little bit smaller, but it’s not going away and there’s still ample market for us to grow into as a company. So, I still think that even though standard has not had the start we would have wanted it to have, I still think it’s going to be, longer term, a nice growth driver for Teleflex, and it’s going to grow into the market. And by the time we get to our penetration point, we’ll see what’s happening with GLP-1s, whether it was an air pocket or not. I think, more broadly, what I’m more encouraged by is that 98% of Teleflex’s – 98% plus percent of Teleflex’s portfolio has no impact from GLP-1. So, I think, investors are probably branding everybody as GLP-1 impacted right now just because of all the hype about it. But as you break down the different company components and what we know right now, we can see it as 98% plus of our company not impacted.
Operator:
Your next question comes from the line of Matthew O’Brien with Piper Sandler. Your line is open.
Samantha:
Hi. This is Samantha on for Matt. A quick question from us on the MSAs. What do you think – you talked a little bit about financials on the topline, but what about the potential of lost revenue on both top and bottom line?
Liam Kelly:
So, from the – just to be clear, the MSA, the manufacturing service agreement?
Samantha:
Yes, that’s right.
Liam Kelly:
Okay. So, as Tom said in his prepared remarks, the early close will lose about $4 million in revenue. From an EPS impact, it’s around $0.01 or thereabout.
Thomas Powell:
Very minimal.
Liam Kelly:
Minimal, yes. So, it’s around – it’s fairly minimal from an EPS perspective, this year, and most investors will know that the MSA has now gone completely, and there was around $70 million in revenue in a full year and around $0.25 in earnings in a full year. So, that will help individuals with their modeling. So, I think the greater impact to earnings per share in this year is, obviously, the early close of Palette, which costs around $0.10. And then FX has cost us, Tom, I think another approximately $0.05 or thereabout?
Thomas Powell:
That’s correct.
Liam Kelly:
Okay.
Samantha:
That’s perfect. Thank you so much.
Operator:
Your next question comes from the line of Craig Bijou with Bank of America Securities. Your line is open.
Craig Bijou:
Good morning. Thanks for taking the questions. I know we’re at the end, so I’ll keep it to one topic. Wanted to ask on MANTA. Liam, I think you mentioned it in your prepared remarks. I don’t think we’ve talked about it in a while. So, just wanted to see, you know, some of the strength there? Was it the recovery in the procedures that MANTA is used in or are you seeing better adoption? And then maybe just some comments on how MANTA will contribute to your growth as part of your long-term plan or over the next couple of years?
Liam Kelly:
Yes. So, MANTA is obviously launching in many jurisdictions and geographies, right now. We saw some nice strength as we’ve gone through the three quarters in Asia. And we believe it will be a multiyear driver for us, Craig. It’s a unique product. It’s – I don’t think we’re gaining honestly from any type of surge – any type of procedural rebound, because we’re still penetrating the market, still bringing it to new customers. And the uniqueness of the product, it still gives us a significant benefit and it will be a multiyear driver for us. We’re absolutely – within the high-growth portfolio, if you look at it, you’ve got some really nice products within their, you’ve got MANTA, you’ve got the Vidacare portfolio, you got our PICCs, you got Z-Medica. You’ve got Titan that had a little bump along the road. You got UroLift that had a bump, but now you’ve got Barrigel and the whole Palette and interventional urology within that high growth. So, feel really good about MANTA. And I suppose you’re right. It doesn’t get as much attention as it used to when it started its journey.
Craig Bijou:
Thanks.
Operator:
That is all the time we have for questions this morning. Our conference call for today is now concluded. Thank you all for your participation. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to the Teleflex's Second Quarter 2023 Earnings Conference Call. [Operator Instructions]. And now I will turn the call over to Mr. Lawrence Keusch, Vice President of Investor Relations and Strategy Development.
Lawrence Keusch:
Good morning, everyone, and welcome to the Teleflex Incorporated second quarter 2023 earnings conference call. The press release and slides to accompany this call are available on our website at teleflex.com. Please note that webcast viewers will have the ability to advance the presentation slides on their own, simply follow along with the presentation as we proceed through the call. As a reminder, a replay will be available on our website, those wishing to access the replay can refer to our press release from this morning for details. Participating on today's call are Liam Kelly, Chairman, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks, and then we will open the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in this conference call will contain forward-looking statements regarding future events as outlined in the slides posted to the Investor Relations section of the Teleflex website. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. Now I will turn the call over to Liam for his remarks.
Liam Kelly:
Thank you, Larry, and good morning, everyone. It is a pleasure to speak with you today. On this morning's call, we will discuss the second quarter 2023 results, our pending acquisition of Palette Life Sciences and our financial guidance for 2023. Turning to the second quarter, Teleflex revenues were $743.3 million, a year-over-year increase of 5.5% on a reported basis and an increase of 5.9% on a constant currency basis. Second quarter adjusted earnings per share was $3.41, a 0.6% increase year-over-year. We saw stable utilization in the acute care setting in our global markets. The balanced performance in the quarter continues to demonstrate the benefits of Teleflex's diversified product portfolio and broad geographic footprint. From a macro perspective, we continue to see sequential stabilizations with respect to material inflation, and we'll continue to monitor trends during the second half of 2023. Our supply chain remained stable in the second quarter, although we are still not yet at normal levels. As expected, we witnessed a continued stabilization in hospital staffing. This was evident in our second quarter revenue growth as most Teleflex products are exposed to the hospital setting. Conversely, we are still experiencing geographic pockets that are encountering more persistent staffing disruption in the ASC and office side of service, but note that bottlenecks are seeing some easing. Now let's turn to a deeper dive into our second quarter revenue results. I will begin with a review of our geographic segment revenues for the second quarter. All growth rates that are referred to are on a constant currency basis unless otherwise noted. Americas revenues were $424.7 million, which represents 3% growth year-over-year. In particular, we saw strong performances in our Vascular, Interventional and Surgical businesses. EMEA revenues of $147.8 million increased 0.7% year-over-year. During the quarter, we saw strength in our vascular and urology drainage businesses. Turning to Asia. Revenues were $86.7 million, increasing 19.1% year-over-year. During the second quarter, we saw stable demand across the region, including growth in excess of 20% in China. From a product perspectives, we saw a strong double-digit growth in Interventional Access and Interventional Urology in the region. Let's now move to a discussion on our second quarter revenues by global product categories. Commentary on global product category growth for the second quarter will also be on a constant currency basis. Starting with Vascular Access. Revenue increased 6.6% to $173.8 million. We executed well during the second quarter. Initial launch activities for our next-generation Arrow VPS Rhythm DLX navigation device and the new Arrow PICC pre-loaded with the NaviCurve Stylet have generated a positive customer response. Over the long term, we remain positioned for dependable growth with category leadership in Central Venous Catheters and midlines, anticipated share gains with our novel coated PICC portfolio and new product introductions. Moving to Interventional Access. Revenue was $124.8 million, up 9.6% year-over-year. Procedure volumes remained stable in the quarter, and we continue to benefit from our diversified portfolio. Balloon pumps, right heart catheters and access and closure all grew at double-digit rates. MANTA continues on a trajectory for strong double-digit growth in 2023. Turning to Anesthesia. Revenue was $100.8 million, down 3.6% year-over-year. A tough year-over-year comp due to timing of military orders in the prior year period impacted results. In our Surgical business, revenue was $106 million, up 7.7% year-over-year. In the quarter, we advanced our integration of Standard Bariatrics and training of new surgeons on the use of the Titan SGS Stapler in sleeve gastrorectomy procedures is accelerating. For Interventional Urology, revenue was $77.8 million, representing a decrease of 2.3% year-over-year. Once again, we witnessed year-over-year growth for UroLift in the hospital setting, but the office side of service remains challenging. The overseas launch activities continue to progress in line with expectations with Japan UroLift usage growing in line with our expectations. OEM revenues increased 19.8% year-over-year to $84.1 million. The strength in the quarter was broad-based across our portfolio, with the double-digit growth in all of our product categories, including micro catheters. We continue to have good visibility into the business and see solid demand dynamics throughout 2023. Second quarter other revenue increased 4.8% and to $76 million year-over-year. We continue to expect all MSA revenues to cease at the end of 2023. That completes my comments on the second quarter revenue performance. Turning to some commercial updates. On July 26, we announced a definitive agreement to acquire privately held Palette Life Sciences for an upfront cash payment of $600 million at closing and up to an additional $50 million on the achievement of certain commercial milestones. The acquisition will expand Teleflex Interventional Urology to include a portfolio of fast-growing Non-Animal Stabilized Hyaluronic Acid or NASHA spacer and tissue bulking products that improve patient outcomes in urology, urogynecology disorders, colorectal conditions and radiation oncology procedures. Palette is estimated to generate net sales of approximately $56 million on a stand-alone basis in fiscal year 2023. We believe Palette will contribute meaningfully to our growth in the coming years with revenue growth in the high-teens to low-20% range year-over-year in 2024. The strong growth profile for Palette gives us further confidence in our ability to deliver on our 2023 to 2025 LRP growth objectives. The Barrigel rectal spacer is the flagship product for Palette and generates the majority of the company's revenue. Barrigel is a NASHA spacer with a compelling value proposition, driven by a reduction in radiation delivered to the rectum during prostate cancer radiation therapy, while increasing tumor control and patient quality of life. In addition, the Palette Life Sciences portfolio also includes Deflux and Solesta, which are NASHA-based tissue bulking agents designed to treat pediatric vesicoureteral reflux and fecal incontinence, respectively. The acquisition of Palette Life Sciences will allow us to incorporate this exciting high-growth and high-margin technology into our Interventional Urology business units along with our well-established global call points. We are focused on bringing urologists and other specialists more innovative technologies that can positively impact patient care. The acquisition of Palette is attractive for 3 primary reasons. First, Barrigel is a differentiated rectal spacer with a strong growth profile following FDA clearance in May of 2022 and represents a highly complementary product to our existing Interventional Urology business. In recent years, the treatment of prostate cancer has increasingly utilized hypofractionated radiation therapy, which uses higher doses of radiation in fewer treatments. In order to reduce radiation associated complications, usage of temporary rectal spacers has grown as a way to protect healthy rectal tissue from harmful radiation. Barrigel has grown by expanding market adoption, since its launch due to its unique product features. Unlike other technologies, Barrigel is easily sculpted when placed between the prostates and rectum, providing comprehensive protection from radiation therapy. The culpability allows the physician to achieve predictable protection of healthy rectal tissue prior to radiation therapy. Barrigel is also highly visible on transrectal ultrasound, which aids accurate placement is biodegradable and offers an one-step assembly of the delivery device in all sites of service. Second, there is a large and growing global market for rectal spacers. The American Cancer Society estimates that there will be 288,000 new cases of prostate cancer in the United States with the incidents growing 3% a year. In addition, the increasing use of hypofractionated radiation therapy is driving demand for rectal spacers to protect healthy tissue. Barrigel was cleared for marketing in the United States and Australia and is CE Marked. We expect to gain market clearance in additional geographies over the coming years. Third, the acquisition of Palette is reflective of our disciplined capital deployment strategy. From a strategic perspective, the addition that Palette's NASHA portfolio complements our strong presence in the treatment of benign prostate enlargement. Of note, urologists performed the majority of rectal space replacements, which will leverage our broad and established sales organization. Today, 97% of physicians using UroLift also treat prostate cancer. In addition, the treatment of prostate cancer is not deferrable. So we are adding another durable growth driver to our portfolio. We also expect interest in rectal spacers to provide opportunities to cross-sell UroLift. From a financial point of view, the transaction is consistent with our strategy to acquire assets that are accretive to Teleflex's growth rate and margins. Palette's adjusted gross margin will be accretive to both the corporate average and the Interventional Urology business unit. In addition, we expect Palette operating margin to enhance the corporate average in the near term. Finally, post close, our balance sheet will remain sound, allowing us to continue to execute on our long-term capital deployment strategy. The acquisition is subject to customary closing conditions, including receipts of certain regulatory approvals and is expected to be completed in the fourth quarter of 2023. We look forward to welcoming the Palette employees to Teleflex. Turning to an update on the Titan SGS stapler. We continue to execute on our commercial strategy for the Titan SGS power stapling device for use in sleeve gastrorectomy procedures to treat obesity. Feedback for the Titan stapler remains positive, and we remain confident in the value proposition for the Titan SGS stapler. The 23-centimeter continues staple line enables ideal pouch creation and no overlapping staples that are common with traditional powered staplers. We are optimistic that over time, we will be able to generate data that shows a reduction in complications and meaningful time savings per procedure. Despite the continued positive feedback from the field, we now expect Titan stapler revenues to be in the high-teens for 2023, which is lower than what our original guidance for 2023 had assumed. Value Analysis Committee clearance has taken longer than we anticipated, which has slowed our ability to train surgeons. We have learned from the early experience and have refined our strategies for gaining VAC approval. Our efforts are taking hold with more than 2x the number of surgeons trained in the second quarter of 2023 versus the first quarter of the year. Moreover, we have a strong pipeline of surgeons in queue to be proctored. So we expect further improvement through the year. We continue to monitor the usage of GLP-1 drugs in treating obesity. Based on our market checks, it is our sense that GLP-1s had some impact on bariatric surgery volumes in the second quarter. It remains too early to assess the long-term impact on the market given questions on reimbursement and safety profile. In the interim, we remain acutely focused on penetrating a large sleeve gasterectomy market that is in excess of 120,000 procedures in the United States given the very early stages of the Titan stapler launch. We remain confident that the Titan stapler will be a meaningful contributor to our high-growth portfolio through the LRP period. That completes my prepared remarks. Now I would like to turn the call over to Tom for a more detailed review of our second quarter financial results. Tom?
Thomas Powell:
Thanks, Liam, and good morning. Given the previous discussion of the company's revenue performance, I'll begin with margins. For the quarter, adjusted gross margin was 59%, a 60 basis point decrease versus the prior year period. The year-over-year decrease was primarily due to continued cost inflation, product recalls and unfavorable impact on productivity due to raw material supply, partially offset by favorable price, lower logistics and distribution-related costs and benefits from cost improvement initiatives. Turning to price. There is no change to our expectation for at least 50 basis points of positive price year-over-year in 2023. Adjusted operating margin was 26.6% in the second quarter. The 90 basis point year-over-year decrease was the result of flow-through of gross margin, increased headcount and employee-related expenses, investments to grow the business and the inclusion of Standard Bariatrics. Net interest expense totaled $16.6 million in the second quarter an increase from $11.2 million in the prior year period. The year-over-year increase in net interest expense reflects higher interest rates versus the prior year, partially offset by a reduction in average debt outstanding. Our adjusted tax rate for the second quarter of 2023 was 10.8% compared to 12% in the prior year period. The year-over-year decrease in our adjusted tax rate is primarily due to a reduction in tax costs resulting from U.S. tax law requiring capitalization of R&D effect. At the bottom line, the second quarter adjusted earnings per share was $3.41 and an increase of 0.6% versus prior year. Turning now to select balance sheet and cash flow highlights. Cash flow from operations for the 6 months was $170.6 million compared to $101.9 million in the prior year period. The increase was primarily attributable to lower tax payments and favorable changes in working capital. Moving to the balance sheet. Our financial position continues to provide its flexibility to operate the business and execute it on our disciplined capital allocation strategy. At the end of the second quarter, our cash balance was $250.8 million as compared to $292 million as of year-end 2022. The reduction in cash on hand is primarily due to $154.5 million of payments on our senior credit facility, partially offset by $131.2 million of free cash flow generated during the first 6 months of 2023. Net leverage at quarter end was approximately 1.6x, which remains well below our 4.5x covenant. Turning to financial guidance. Starting with the acquisition of Palette Life Sciences. As mentioned previously, Palette Life Sciences is expected to generate net sales of approximately $56 million in 2023. Assuming a December 1, 2023 close date, the acquisition is not expected to significantly impact Teleflex's 2023 revenue. In 2024, we expect the business will achieve year-over-year revenue growth in the high-teens, below 20% range. Assuming December 1, 2023 close, the transaction is expected to be approximately $0.15 and $0.35 diluted the company's adjusted earnings per share in 2023 and in 2024, respectively. Beginning in fiscal year 2025 and thereafter, the company expects the acquisition to be increasingly accretive to adjusted earnings per share. Teleflex plans to finance the acquisition in borrowings under it's revolving credit facilities and cash on hand. At signing of the transaction, we remain in a solid financial position with pro forma net leverage of approximately 2.5x. Accordingly there is no change to our stated long-term capital deployment strategy. Moving to our outlook for 2023. Given our operational performance in the second quarter and our second half outlook, we are revising our 2023 financial guidance. Specifically, we are increasing the bottom end of our 2023 constant currency revenue guidance by 50 basis points to 5.5% to 6.25%. Turning to foreign exchange. We now assume a positive impact from foreign exchange translation of approximately $8 million or 30 basis points to GAAP growth in 2023. This compares to our prior guidance, which assume that $10 million or a 35 basis point headwind for 2023. Note, our second quarter revenue results reflect a foreign exchange result that was approximately $6 million favorable to what was previously expected. The balance of the updated full year 2023 impact of changes in foreign exchange rates is expected over the second half of 2023. Our revised foreign exchange guidance for 2023 captures the actual rates in the second quarter and now assumes current foreign exchange rates, including a euro to dollar exchange rate of $1.10 in the second half of the year. Considering the revised foreign exchange headwinds, we expect reported revenue growth of 5.8% to 6.55% in 2023, implying a dollar range of $2.953 billion, $2.974 billion and implying an increase to the low end of the dollar range of $32 million and the high end of $80 million. There are no changes to our outlook for gross and operating margin in 2023. Below the line, we now expect net interest expense to approximate $77 million in 2023, which reflects net incremental borrowings under our revolver for the acquisition of Palette. We are maintaining our 2023 guidance for adjusted earnings per share of $13 to $13.60. Our adjusted EPS outlook has been updated to include $0.15 of dilution from the acquisition of Palette; $0.15 dilution associated with the recall of ET Tubes and the Endurance catheter during the second quarter offset by $0.15 of foreign exchange benefit and the balance from favorable operating performance, including better-than-expected results in the second quarter and higher growth expected in the second half of the year. That concludes my prepared remarks. I would now like to turn it back to Liam for closing commentary.
Liam Kelly:
Thanks, Tom. In closing, I will highlight our 3 key takeaways from the second quarter of 2023. First, our diversified portfolio and global footprint drove durable growth in the second quarter. Our execution remains strong. We are launching new products and our margins remain healthy. Second, the solid second quarter performance keeps us well positioned to deliver on our financial guidance for 2023. As we look into the second half of 2023, we anticipate stable to improving macro conditions. Third, we will continue to focus on our strategy to drive durable growth. We will invest in organic growth opportunities and drive innovation, expand our margins and execute on our disciplined capital allocation strategy to enhance long-term value creation. We are excited about the acquisition of Palette Life Sciences. We believe that the acquisition will be a meaningful contributor to our growth in the coming years, be immediately accretive to gross margins and will enhance our adjusted operating margins in the near term. In turn, we have further confidence in our ability to deliver on our 2023 to 2025 LRP revenue objectives. That concludes my prepared remarks. Now I would like to turn the call back to the operator for Q&A.
Operator:
[Operator Instructions]. And our first question comes from Shagun Singh of RBC.
Shagun Chadha:
So by our math, the acquisition would add about 50 basis points to overall Teleflex growth and 400 basis points to Interventional Urology segment. Just is that in the ballpark? And does this help offset some of the weakness in UroLift? Or is your 8% to 9% LRP still intact?
Liam Kelly:
Thank you very much for the question, Shagun. I'll start with your question as it relates to the LRP. As it relates to the LRP, the acquisition of Pallet emboldens our confidence in at least achieving the 6% growth as laid out in our LRP. And here are the building blocks. Durable core will grow at 5%. I think given the performance so far this year and what we expect for the remainder of the year, we feel super confident in that 5%. The high-growth portfolio will be growing at least 12%. And within that, the Interventional Urology business unit, which will include Palette, will be growing at least 8%. So this addition of Palette ensures our ability, we believe, to achieve our 6% LRP growth that we laid out in our Capital Markets Day. With regards to the addition, what addition that it will make into the future growth of Teleflex, I mean, your math is pretty spot on. It's delivering $56 million this year. It's going to grow in the high-teens, to the low-20s in 2024. And I do believe that, that kind of a number should be sustainable into 2025 as well. So obviously, your math is pretty right on the money. And I think it's an important point to note, as I outlined in my prepared remarks, the gross margins from Palette is a really important factor. And so far as it's not alone accretive to Teleflex. It's accretive to the Interventional Urology business unit today and is accretive to the high-growth portfolio. Thanks for the question, Shagun.
Shagun Chadha:
And just as a follow-up on UroLift, can you just elaborate on trends you're seeing? I know that the patient volume comps were a little easier this quarter. But just on a comp-adjusted basis, can you elaborate on trends you are seeing?
Liam Kelly:
Yes. We're still seen through the first half of the year a reduction in patient flow to the urologists. I think from -- within the quarter, there were some green shoots, I guess, when you see that the hospital rate of growth continued. We still see pressure in the office side of service, and that still remains somewhat of a challenge to us. We continue to train a robust amount of surgeons. And actually, we saw a tick up in the amount of surgeons that we trained in Q2, but the office still remains a troublesome side of service for this product in the quarter, Shagun.
Operator:
Our next question comes from Jayson Bedford of Raymond James.
Jayson Bedford:
I wanted to follow-up on the comments on the Titan Stapler. It seemed like the revision in the guide there, you seem depended on longer VAC committee approvals. And I'm just wondering, kind of what's the source of the pushback there? Do you need more clinical data? Is it a price issue? Just love to dig in on that a little bit more.
Liam Kelly:
Yes, Jayson. I mean, obviously, our initial expectation at the low end was $30 million. It's now in the high-teens. We still expect Titan to be a significant contributor to the LRP. The pushback as we go through the VAC committees and the VAC committees have the knock-on effect of having an impact on the proctoring. Now as I also said in my prepared remarks, we doubled the number of surgeons we proctored from Q1 to Q2, so that's encouraging. It's just time, Jayson, is the biggest issue. We would have thought that this product because it's functioning exceptionally well. That's what's very encouraging. The product is doing exactly what it's supposed to do. I think what's also important is that it's a very, very big end market, $300 million. So once we get through the value analysis committees, the product gets adopted and it's going pretty well. It's just taking us longer than we thought. It's early in the ramp. It's a big market. We have a path forward. We know what we need to do. It's just taking us longer to get there as we go through that adoption curve. And I think that it's also a -- having the buttress material for the entire year 2024 will be an important factor for us. Technically, our product doesn't need buttress because it's a complete line of staples. But 60% of Bariatric surgeons use buttress when they do a gastric sleeve and it is the standard of care. And a surgeon will tell you, I use buttress because I want to sleep at night. And it's just a standard of care. And I think having that in 2024 will also help get us through. But it's simply time, Jayson. There's no major pushback. It's not a pricing issue. It's not a product performance issue. We've got the clinical data that we need. So we have everything that we need to get through, but it's just taking longer for these VAC committees to come together and allow us through the system.
Jayson Bedford:
Okay. Liam, that's very helpful. And just quickly as a follow-up. OEM continues to be strong there. Can we assume there's nothing kind of onetime or stocking in that number and you're still confident in which should be a strong double-digit growth outlook for OEM?
Liam Kelly:
Yes. I think OEM has performed exceptionally well, not just this year, but over the last 2 years as well, coming in just shy of 20% stellar performance. This is a business that we have really good visibility into. There are no one-time stocking major items to answer your question directly. This is pure performance. It's taking share from other competitors in the market. It is also that acquisition that we did a number of years ago, really helping us go along, but it's really good performance by Greg and the entire team in the OEM division. And I do believe that OEM will have good solid double-digit growth this year, and I do believe that the future is good for that over the foreseeable future with the visibility we have.
Operator:
Our next question comes from Anthony Petrone of Mizuho Americas.
Anthony Petrone:
Maybe, Liam, just to pivot to Standard Bariatrics. Just an update on traction in the quarter, expectations through the end of the year for Standard. We've been hearing obviously some noise on the GLP-1s impacting Bariatric from Intuitive. So just an update on bariatric and then I'll have a follow-up on earnings.
Liam Kelly:
Yes, absolutely, Anthony. And as we said during our prepared remarks, we're now expecting the high-teens for our Standard Bariatrics. I think that there's some impact from GLP-1s. But the main issue is getting through these VAC committees. And therefore, you have to get through the VAC committee before you proctor. And as I answered to Jayson's question, we doubled the number of surgeons that we proctored from Q2 to Q1. Product is performing very, very well. The introduction of buttress will help us. I do believe that GLP-1s have some impact, but it's not the big impact. I mean we're just stacking to ramp within this curve. And I do think that there's mixed views on GLP-1s, they get the reimbursements, it is for a shorter period of time. And therefore, if you talk to most Bariatric Surgeons, they think it's having a shorter-term impact. But in the longer term, they don't see it having a long-term impact on gastric sleeve surgeries. Just the weight loss from gastric sleeve is so more significant than it is from the GLP-1s. But we're watching it very, very closely, Anthony, and thanks for the question.
Anthony Petrone:
And then maybe for Tom, just on margins and the progression here, revised 26% to 26.75%. And maybe just a recap on looking out through the LRP as we look forward to '24, '25, just how we should be layering margin expansion in according to or based on what's still out there for the LRP and how we can translate that into earnings power? Now it's a little bit confounded down to the earnings line with the Palette acquisition and some of the below-the-line sort of moving parts. So how do we layer in? How do we think about margin expansion from here based on the current guidance out through the LRP? And how does that play in the earnings power now that we have an additional drivers in the nonoperating lines?
Thomas Powell:
Okay. Well, as we spoke earlier in the year, we reaffirmed the LRP guidance at that point in time. The way I would think about the addition of Palette is that it is a product that we expect to do about $56 million in revenue this year on a full year basis. Obviously, we wouldn't have it for the entire year. But then to grow in the high-teens to low-20s over the next couple of years. And as we had mentioned, we expect it to be margin accretive to the IUBU business units to all of Teleflex in the high-growth portfolio. So we see this as slotting in very nicely and providing some additional comfort as we look out into the future years in our margin progression.
Operator:
Our next question will come from Larry Biegelsen of W. F.
Nathan Treybeck:
This is Nathan Treybeck on for Larry. Can you just talk about Palette like the overlap with UroLift position, how penetrated is the U.S. market? And so far, is Barrigel expanding the market or it taking share?
Liam Kelly:
Yes, Nathan, thank you very much for the question. So we see this as a market development opportunity. If you look at our existing interventional urology customer base, only 20% of them use the Barrigel spacing technology today and 97% of them actually treat prostate cancer. So this is a market expansion opportunity for us in the domestic market within the United States. The product is approved in EMEA, and it's also approved in Australia. We will be expanding approvals into other geographies as we take this under our wing. But we definitely see this as a margin expansion opportunity. And we definitely see there's an opportunity to leverage our existing sales force and leverage that channel. We have a super global channel now into the urologist, and we believe that we can expand the market. There's other spacing technologies out there. I think between having another company talking about spacing and other company raising awareness. We believe we have a better product than anything that's out in the market today. It's sculptable. It is visible. It is easy to inject. It doesn't solidify overly quickly. It's a one-step process. it's reversible. We've had excellent clinical data. There have been zero embolisms that have been 0 device-related adverse events, and we have robust clinical data to support the product. We love the growth profile. We love the margin profile and we love the synergies within our sales force. And we're not going to build this into our model, but there is the potential that it could have also a halo effect for UroLift in expanding into urologists that previously may not have been open to trying a new technology like UroLift.
Nathan Treybeck:
Okay. And if you could just give us your high-level thoughts on 2024 in light of the acquisition, which is expected to be $0.35 dilutive, like what is your ability to absorb this dilution? I mean, the street has you at $14.50 to an EPS next year?
Liam Kelly:
Yes. Nathan, we're not going to get into 2024 on today's call. We're halfway through the year. We've raised our revenue guidance for the second quarter in a row. We feel really confident about where we're at as a company. We've also -- we've maintained this year's earnings per share guidance even with the $0.15 dilution that's coming from Palette. So we feel really good about where we're at, and we'll get into 2024 guidance when we get to February next year. I've already had made comments on the LRP about our belief and confidence in being able to achieve all aspects of the revenue profile with Palette within our LRP 6% and all the components within that I just laid out.
Operator:
Our next question comes from the line of Matthew O'Brien of Piper Sandler.
Matthew O'Brien:
Liam, just in talking about Palette a little bit here that the Barrigel product got approved in May of last year. You're saying it at least the majority of revenue total per Palette now. So I don't have the numbers, but I'm assuming it's $30 million or $40 million of revenue in a year basically that they've generated already. And then you're saying kind of in high-teens to low-20% growth for next year. I would think that just if they've been able to grow that quickly that you guys at Teleflex to be able to grow it at a similar rate. So why is high-teens, low-20% is the right number? Why isn't it 30%, 40%, 50%? I know you have to integrate it, but why wouldn't it be significantly higher than that, just given how well they did with it on their own?
Liam Kelly:
Well, I think, Matt, everything you say, it's hard for me to push back too hard. We're definitely going to have more sales reps out there. We've got a very strong sales force within the United States and globally for this call point. I mean I think the high-teens low-20s is probably the right number for us right now. If it's better than that, it's better than that and everyone's happy. I think for us, we feel right now that that's the right number. You're correct. We've got to integrate it. It's not the toughest integration on the planet in all transparency. It's 1 call point, 1 big large call point. And then obviously, the [indiscernible], we have a methodology to address that through the addition of clinical trainers. And this is an investment hypothesis for us with the addition of Palette. We are going to continue to expand this market and grow this market. And if it's better in the high-teens and low-20s, we'll let you know, and we'll grow it from there. But it's -- we feel it's a great transaction. And if it's better than we expect, then the multiple is better than we expect and everything within that dynamics of it is better than we expect.
Jayson Bedford:
Got it. That's understandable. I appreciate that. And then just back to UroLift, I know it's getting to be a smaller part of the overall business, but there's other areas of med tech that just have not recovered from the pandemic. I can think of women's health as one area. Is this a category that especially in the outpatient setting and the physician's office setting that is just probably structurally different from now on and let most likely will not reaccelerate? Hence, the 8% to 9% that you talked about last quarter, probably is it going to happen in the future?
Liam Kelly:
Yes. Now in all transparency, when we began the year, I thought that UroLift was going to recover. I expected it to grow somewhere in the region of around 3%. Now as I look forward to the full year, I would expect Interventional Urology, which would include Palette to have a low single-digit decline, something around 3% right now. I think what's changed. The market is huge. The condition is progressive. There are loads of men out there that have BPH. I think the pressure in the office, Matt, as I look at it today, is the real issue. If you go back to '17, '18, '19, we were growing the market because we were using the office call point to bring men in from the drug dropout and the drug category, and we were able to convert those men during that period of time. With the change in reimbursement, with the patient flow, with the lack of staffing, that channel for now is challenged in pulling those men in and expanding the market. So I think that we need to get the office channel addressed. And I just can't see that getting addressed in the next 2 quarters being totally honest. So I think it's going to take at some time to recover. Now having said that, this quarter, we trained more docs than we had the quarter before for a number of quarters. So docs are putting their hands up to get trained. The international profile is excellent. I couldn't be happier with what's happening overseas. And domestically, I think that for the remainder of the year, I think it's going to do what I said it's going to do. There are a couple of green shoots. It was minus 5%. Last year, it was minus 5% in the first quarter it was minus 2.5% this quarter. So there's a couple of green shoots here some positivity there. But I think that it's a challenged call point in that office right now with all of the factors that are playing into it.
Operator:
Our next question will come from Craig Bijou of Bank of America Securities.
Craig Bijou:
So I wanted to start with some of the components of the LRP. And namely, Liam, I think you said that you now expect Interventional Urology, including Pallet to grow at least 8%, which would mean underlying UroLift, longer-term growth takes a step down. So I just wanted to make sure that, that's correct. And maybe what's driving that, is that the -- it sounds like it's the U.S. side, but maybe a little bit more color on what you see over the next several years for UroLift? And then also, Standard Bariatrics. So I know you're expecting some pretty good growth for the next several years. Just wanted to understand how we should think about that growth level in '24, '25 relative to what you had expected before?
Liam Kelly:
Yes. I mean I think -- I'll start with the first part of your question. And your assumption and your math is, I can't fault it, you're absolutely correct. But that's why I'm so confident in the 6% LRP. I'm not expecting any here or I'm not expecting anything from UroLift within the LRP right now. The international market is strong. If the domestic market recovers, it's great for investors. It's great for Teleflex, and it's great for our LRP. The margin profile is strong. So in effect, in my mind, this basically takes UroLift off the table in regards to the LRP. With regard to Standard Bariatrics, like I said earlier, it's a huge market. Once we get through the VAC committees and the proctoring of the surgeons. Our goal here is to continue with the performance of the product to continue to take our appreciated share in the bariatric sleeve market. Bariatric sleeve market isn't going away because of GLP-1s, it's going to be there forever. There is a place for this. If you talk to any surgeons, they will tell you that. So I do believe that it's going to be a meaningful contributor to the LRP for our '24 and '25 as we grow into that huge market.
Craig Bijou:
Got it. And just as a follow-up on '24, I know you guys aren't going to provide guidance or talk about what the Street has estimated. But would love to hear any of the puts and takes that are going to affect '24. Obviously, you have the Palette acquisition, you have the MSA rolling off. So I just want to ask you specifically on what we should be thinking about when we're thinking about '24 EPS and if maybe the messaging that you guys have given previously is not fully quite reflected in the Street's estimates?
Liam Kelly:
So I'll let Tom comment on the EPS. I mean, I think you've hit the 2 main ones that I think the Street needs to think about. Obviously, the MSA, the $70 million of revenue that goes away next year, then you layer in -- and that's at very low margins and has an impact on EPS of about $0.25. But then you layer in the Palette acquisition, and of course, Palette acquisition adds back in $56 million of revenue on the base year and obviously then growing at high-teens to low-20s. So that -- those are the puts and takes on the top line. And I don't -- I'm not expecting Tom to get into any real details about 2024 EPS, but I think those are the 2 main ones, Tom, aren't they?
Thomas Powell:
They are. I will say that a couple of things that we're watching as well. Our foreign exchange rates, which have shown a nice improvement recently, and so that should give us a half year benefit next year. And we're also starting to see some improvements in the areas of inflation. So we're seeing our sea freight has already come back and shipping times are improving dramatically, which will allow us to be able to do a couple of things, including bringing down our level of inventories, which will obviously help out to cash flows as we continue to manage those down. But I think, yes, the key things that are changing are the MSA, Palette and then the -- we're watching FX and inflation closely, but those could be some tailwinds for us.
Operator:
Our next question comes from Kristen Stewart of CL King.
Kristen Stewart:
Tom, I was just wondering on the bottom line, why just reiterate the guidance rather than tightening the range?
Thomas Powell:
Well, it's a fair question. As we think about what's happened is that we looked at all the puts and takes of the quarter and there are end of the year. And so if you -- if you think about what we've commented on, the EPS range was really driven by adding in the incremental dilution from Palette of $0.15. And then associated with the recalls in the second quarter, we had another $0.15 of expense. The FX, as I mentioned, has improved. And as a result of both second quarter and full year expected benefit. That actually is an offset of $0.15. And then the balance is a combination of improved operating performance in the second quarter and second half. So essentially, a number of changes since our last guidance, that pretty much net out. As Liam commented, we are covering the dilution associated with the Palette acquisition and still maintaining guidance. So we're -- we're effectively raising, if you will, from that standpoint that we're covering something new. But as we continue to monitor the year, we'll look at it and reevaluate the range in the third quarter.
Operator:
Our next question will come from Richard Newitter of Truist Securities.
Unidentified Analyst:
It's Ling on for Rich. So maybe I'm wondering if you could provide some color on the trends in your high-growth portfolio, like including MANTA thermostatic devices, et cetera.?
Liam Kelly:
Yes. As I said in my prepared remarks, MANTA continues to penetrate the market is on track for real solid double-digit growth. If you look at the other areas of the high-growth portfolio, we've discussed 2 of them already. And we would expect that UroLift for the high-growth portfolio to be well within those high single-digit growth. I do want to take a moment on the durable core, if you don't mind. I think that the durable core has been performing really, really solidly. We've had excellent performance from OEM that was mentioned earlier, but Interventional Access has had a great performance as has Asia Pacific. And as investors familiar with Teleflex will be aware of both Interventional and APAC have very strong gross margins for the company. So the whole portfolio of Teleflex, we believe is working really, really well. From the durable core to the high-growth. And we believe that for 2 quarters in a row, we called up our revenue forecast 2 quarters in a row. And we have seen significant improvement from last year. I think back last year, we grew 4.3%. Look at our guidance for this year, the midpoint has at almost 5.9%. So we've seen significant improvement. And again, this is the advantage of a diversified global company. Not everything is going to go the way you think. But when you add it all together, it all makes sense. And it's -- I think it's a solid performance, and the addition of Palette is really going to help us.
Unidentified Analyst:
That's great. So maybe I'll follow-up on margins. Could you walk us through the cadence of gross margin operating margin throughout the year?
Liam Kelly:
You want the cadence of gross margin and operating margin throughout this year?
Unidentified Analyst:
Correct.
Liam Kelly:
Okay. I might ask Tom to cover that.
Thomas Powell:
Yes, absolutely. Well, I think first of all, one thing that you may want to understand is just that FX has got a pretty meaningful impact on how margins actually play out. We actually saw foreign exchange have a meaningful positive impact in the first quarter. It turned slightly negative in the second quarter as it impacts gross margin. And then the third and fourth quarter, we expect after the FX impact -- or I should say we expect the FX impact to be even greater to gross margins. So if you were to strip out the foreign exchange impact, what you'd see is a sequentially improving gross margin throughout the year with a fairly sizable improvement from the first to the second quarter and then again from the third to the fourth quarter. If you were to maintain the FX in there, what you're going to see is a gross margin that is about the same each quarter, a little bit softer in the third, a little bit stronger in the fourth as what we experienced here in the second quarter. In the second quarter, we had a couple of puts and takes. Obviously, we had the recall expense. Foreign exchange, as I mentioned, was modestly negative impact, but we also had favorable pricing and some credits from foreign countries that provided some benefit. So overall, I would say that pay attention to how FX may play out. And if you were to strip that out, you'd see sequentially improving gross margin. And it's very similar on the operating margin. If you strip out the FX impact, you would see sequentially improving op margin throughout the year. Obviously, we do have to consider FX. And as a result, what you're going to see is by a little bit softer gross margin in the third quarter and something the same or a little bit stronger in the fourth quarter as what we saw in the second.
Operator:
Our next question will come from George Sellers of Stephens.
George Sellers:
I guess switching back to Palette quickly. With the 97% of UroLift users, that are also treating prostate cancer. And I believe you said 20% already used Barrigel. Are they also already using a space or product? Or is this more of a white space opportunity?
Liam Kelly:
So there would -- George, great question. There would be a white space opportunity of about 60%. So an addition -- in total, about 40% of them are using a spacing product of some sort, 20% of them using Barrigel. And so therefore, you would be left at around 60% of white space. And again, I will reiterate. For us, this is not about attacking the other 20%. This is about attacking the 60%, educating the physicians on the benefits of using spacing, the benefits of Barrigel as a spacer, the ones I outlined already and to remove that toxicity from other organs around the prostate. So it's really around white space, George, growing into an existing customer the urology, oncologists, which is an excellent call point for us to get into where some of the product is used by those individuals. So really encouraged by that, and I think it's a nice opportunity.
George Sellers:
Okay. That's really helpful. Switching to the OEM segment, this continues to really perform exceptionally well. And it sounds like you've got visibility to that continuing the remainder of the year. But could you just give some additional detail on the pieces driving that outperformance? And how should we be thinking about that sustainability over the LRP?
Liam Kelly:
Yes. I think great question again, George. I think that's the beauty about the OEM businesses is this right across the Board. We've got a really strong double digit in the catheter business. We've got a really strong double digit in the suture business. We got really strong double-digit in the completed product business. And obviously, the complex catheters within those catheters are performing exceptionally well. It's right across the Board. You're correct. We have great visibility to this business. This is one business where the customers order well ahead in advance to make sure that they have capacity booked. And again, I think we have -- we're really encouraged by what we see. It is dilutive to our gross margins. But God, is it accretive to our op margins? This is a great business for us and one that's performing exceptionally well with long visibility. And if I could find another tuck-in to put into OEM, we've got the capital available, I do it in the morning because it's -- we've got solid growth within there and a really strong customer base.
Operator:
That is all the time that we have for questions this morning. I would like to turn the conference back to Lawrence Keusch for closing remarks.
Lawrence Keusch:
Thank you, Jayal, and thank you to everyone that joined us on the call today. This concludes the Teleflex Incorporated Second Quarter 2023 Earnings Conference Call.
Operator:
You may now disconnect.
Operator:
Good morning, ladies and gentlemen. Welcome to the Teleflex First Quarter 2023 Earnings Conference Call. At this time, all participants have been placed in a listen-only mode. At the end of the company's prepared remarks, we will conduct a question-and-answer session. Please note that this conference call is being recorded and will be available on the company's website for replay shortly. And now I will turn the call over to Mr. Lawrence Keusch, Vice President of Investor Relations and Strategy Development.
Lawrence Keusch:
Good morning, everyone, and welcome to the Teleflex Incorporated first quarter 2023 earnings conference call. The press release and slides to accompany this call are available on our website at teleflex.com. Please note that webcast viewers have the ability to advance the presentation slides on their own, simply follow along with the presentation as we proceed through the call. As a reminder, a replay will be available on our website. Those wishing to access the replay can refer to our press release from this morning for details. Participating on today's call are Liam Kelly, Chairman, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks, and then we will open the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in the slides posted to the Investor Relations section of the Teleflex website. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. Now I will turn the call over to Liam for his remarks.
Liam Kelly:
Thank you, Larry, and good morning, everyone. It is a pleasure to speak with you today. For the first quarter, Teleflex revenues were $710.9 million, a year-over-year increase up 10.8% on a reported basis and an increase of 13.2% on a constant currency basis. First quarter adjusted earnings per share was $3.09, a 7.3% increase year-over-year. We had a strong start to 2023 as momentum exiting last year continued into the first quarter. Even when excluding the impact of five extra shipping days in the first quarter, our underlying growth was robust at 7.1%. As a reminder to investors, a day is typically worth approximately 1% revenue growth in a quarter. For the first quarter of 2023, each extra day was in actuality slightly in excess of 1% growth. And when strung together, the five extra shipping days added approximately 6% to our constant currency growth. In the quarter, both the high-growth portfolio, excluding UroLift, and the durable core grew in the low-double-digits year-over-year, excluding the five extra shipping days in the quarter. Behind an improving procedure environment, we executed well during the quarter with all global product categories driving growth. The balanced performance in the quarter continues to demonstrate the benefit of Teleflex's diversified product portfolio and broad geographic footprint. In the quarter, we saw strong contributions from our interventional surgical and OEM product categories. From a geographic perspective, Europe was in line with expectations, while Asia remains a key growth driver. From a macro perspective, we are seeing a stabilization in inflation and supply chain as expected. Of note, we have seen some easing and supply constraints for Tyvek during the first quarter and continue to expect the situation to further improve in the second half of the year as additional industry capacity comes online. We are also seeing a continued improvement in staffing challenges in the hospital setting. This was evident in our first quarter revenue growth as the majority of Teleflex products are exposed to the hospital setting. Conversely, we are still experiencing geographic pockets that are encountering more persistent staffing disruptions in the ASC and office site of service. Now let's turn to a deeper dive into our first quarter revenue results. I will begin with a review of our geographic segment revenues for the first quarter. All growth rates that I refer to are on a constant currency basis unless otherwise noted. Americas revenues were $411.9 million, which represents 9.2% growth year-over-year. We saw growth across the majority of our businesses, including double-digit increases in interventional and surgical revenues. In addition, the results included the impact of the five extra shipping days. EMEA revenues of $143.3 million increased 10.5% year-over-year. The year-over-year growth includes the benefit of the five extra shipping days in the quarter, while the underlying performance reflects continued improvement in the year-over-year procedure volumes that fueled broad-based revenue growth across our product portfolio. Now turning to Asia. Revenues were $78.7 million, increasing 22.8% year-over-year. We saw strength across the region with all geographies posting solid growth during the first quarter. China remained a solid contributor with very high single-digit growth in the quarter. Although surgical procedure activity in China has not yet returned to normal levels following the termination of the zero-COVID policy in late 2022, we saw improvement as we progressed through the quarter. Looking forward, we would expect growth in China to accelerate during the remainder of 2023. Let's now move to a discussion on our first quarter revenues by global product category. Commentary on global product category growth for the first quarter will also be on a constant currency basis. Starting with Vascular Access. Revenue increased 9.2% to $177.7 million. The performance was solid across the portfolio, and we are now past the tough COVID comparisons experienced during 2022. As I noted earlier in the call, we saw some improvement in Tyvek supply in the first quarter and expect further availability in the second half of the year as additional manufacturing capacity for the industry comes online. Of note, our PICC portfolio returned to double-digit growth in the quarter. Over the long-term, we remain positioned for dependable growth with category leadership in central venous catheters and midline, anticipated share gains from our novel coated PICC portfolio and new product introductions. Moving to Interventional Access. Revenue was $116.9 million, up 23.3% year-over-year. We continue to benefit from our diversified portfolio and saw strength across our largest product categories, including complex catheters, balloon pumps and OnControl. MANTA continues to penetrate the large foreclosure market globally. Turning to Anesthesia. Revenue was $93.3 million, up 9.9% year-over-year. Of our larger franchises, hemostatic products, regional anesthesia, and endotracheal tubes all had strong performances in the first quarter, partly offset by LMA single-use masks. In our Surgical business, revenue was $99 million, up 14.3% year-over-year. Among our largest product categories, metal ligation clips and instrument revenue increased double digits year-over-year. In the quarter, we advanced our integration of Standard Bariatrics and trained new surgeons on the use of the Titan SGS Stapler in sleeve gastrectomy procedures. We showcased Titan at the recent Sages Medical Conference, and the surgeon feedback was overwhelmingly positive. For Interventional Urology, revenue was $75.4 million, representing an increase of 0.9% year-over-year. We witnessed growth for UroLift in the hospital setting, but the opposite of service continues to be impacted by staffing shortages. We continue to expect the U.S. end market for UroLift continue to improve as we progress through 2023. The overseas launch activity in Japan and China are progressing in line with expectations. OEM revenues increased 34.5% year-over-year to $77 million. The strength in the quarter was broad-based across our portfolio with double-digit growth in all product categories. We continue to have good visibility into the business and see solid demand dynamics throughout 2023. First quarter other revenue increased 6.4% to $71.6 million year-over-year. We continue to expect all MSA revenues to cease at the end of 2023, implying no MSA revenue in 2024. That completes my comments on the first quarter revenue performance. Turning to some commercial and clinical updates. We continue to execute in our commercial strategy for the Titan SGS powered stapling device for use in sleeve gastrectomy procedures to treat obesity. We recently announced a supply agreement with W. L. Gore & Associates to use the company's GORE, SEAMGUARD Bioabsorbable Staple line reinforcement materials in a staple line reinforcement device designed by Teleflex for use with the Titan SGS stapler. Buttress material is commonly used by surgeons to reduce leaks and bleeding and strengthen the staple line by redistributing the pressure exerted by an individual staple over a wider area as well as provide reinforcement for friable tissue. The ability to offer synthetic buttressing materials alongside the unique features of the Titan stapler should enable Teleflex to further address surgeon clinical needs and preference in the sleeve gastrectomy market. We anticipate launching the Teleflex applicator with Gore buttress materials by year-end 2023. Moving to our hemostatic product portfolio. We have received FDA 510(k) clearance for the QuikCLot Control+ for minor to moderate bleeding in cardiac procedures and bone bleeding following sternotomy. This new indication expands upon the prior indication for temporary control of internal organ space bleeding for patients displaying severe bleeding. The expanded indication follows the completion and analysis of an IDE study that examined the rate at which subjects achieve hemostasis through 10 minutes of hemostatic application and compression at the bleeding site. The study concluded that the quick cost controls plus hemostatic device was superior in achieving clinical hemostasis in cardiac surgery for mild and moderate bleeding. The expanded indications enable QuikClot Control+ utilization across a wider patient population and breath of surgical procedures and expand our global market opportunity for our portfolio of hemostatic products. We will begin promoting our new indication in the coming month. Now moving to an update on the Interventional Access business. We are excited about our building momentum for 2023 with a focus on complex PCI and structural heart. Of note, we continue to focus on driving our innovation engine, and we'll be launching a number of new products over the coming years. Augmenting our channel presence in complex PCI, we recently commenced a limited market release for the GuideLineor Coast with positive initial feedback from physician users. GuideLiner Coast builds upon our successful GuideLiner extension catheter franchise with the addition of a hydrophilic coating to improve deliverability. In addition, we will initiate a limited launch for the Triumph micro-catheter during the second quarter. The Triumph is a unique catheter design that will be supported by a chronic total occlusion clinical study which is planned to enroll patients in 2023. We also continue to advance our Ringer perfusion balloon catheter with two clinical studies currently enrolling patients. Separately, we continue to expand our structural heart presence. Our dedicated salesforce is currently selling MANTA and the Langston dual lumen catheter. Looking forward, we are actively engaged in expanding our product portfolio with the Watson, representing the next product anticipated to launch. The Waston is a unique dual delivery guidewire and pacing wire for use in TAVR procedures. Lastly, I will provide an update on our Vascular Access business. We are excited to announce that we have launched two new devices designed to enhance PICC insertion procedures and reduce the chance of complications. First, we have launched the next-generation Arrow VPS Rhythm DLX device, which provides real-time PICC catheter tip location information using a patient's cardiac electrical activity. The device also features an optional integrated ultrasound module to assist with vascular access, coupled with our tip tracker technology, use of the DLX eliminates the need for confirmatory x-ray, which reduces time to therapy and cost. In addition, we have launched a new Arrow PICC preloaded with the NaviCurve Stylet. The NaviCurve Stylet features an anatomical curb and flexible tip that are designed to self-orientate to patient's anatomy for enhanced PICC advancement into the superior vena cava for successful insertion. That completes my prepared remarks. Now I would like to turn the call over to Tom for a more detailed review of our first quarter financial results. Tom?
Thomas Powell:
Thanks, Liam, and good morning. Given the previous discussion of the company's revenue performance, I'll begin with margins. For the quarter, adjusted gross margin was 59.4%, a 100 basis point increase versus the prior year period. The year-over-year increase was primarily due to price, lower logistics and distribution-related costs and favorable fluctuations in foreign currency exchange rates, partially offset by continued cost inflation including raw materials and labor costs. Of note, we maintained our pricing discipline in the first quarter and continue to expect at least 50 basis points of positive price year-over-year in 2023. Adjusted operating margin was 25.8% in the first quarter. The 10 basis point year-over-year increase was the result of the flow-through of the gross margin, partially offset by headcount and employee-related expenses, investments to grow the business and the inclusion of standard bariatrics. Net interest expense totaled $17.5 million in the first quarter, an increase from $10.2 million in the prior year period. The year-over-year increase in net interest expense reflects higher interest rates versus the prior year, partially offset by a reduction in average debt outstanding. Our adjusted tax rate for the first quarter of 2023 was 11.8%, compared to 11.9% in the prior year period. At the bottom line, first quarter adjusted earnings per share was $3.09, an increase of 7.3% versus prior year. Turning now to select balance sheet and cash flow highlights. Cash flow from operations for the first quarter was $84.3 million, compared to $62.1 million in the prior year period. The increase was primarily due to favorable changes in working capital driven by higher accounts receivable collections, partially offset by an increase in inventories to maintain high customer service levels during a period of elevated global supply chain volatility. Moving to the balance sheet. Our financial position continues to provide us the flexibility to operate the business and execute on our disciplined capital allocation strategy. At the end of the first quarter, our cash balance was $264.1 million as compared to $292 million as of year-end 2022. The reduction in cash on hand is primarily due to $75 million of payments on our senior credit facility. Net leverage at quarter end was approximately 1.7 times, which remains well below our 4.5 times covenant. Turning now to financial guidance. We are very pleased with our first quarter financial performance. Of note, we have seen a recovery in surgical procedures, most notably those that are performed in the hospital, staffing shortages continue to improve in the hospital and inflation and supply chain headwinds have stabilized. Given the solid start to the year, we are updating our 2023 financial guidance. Specifically, we are raising the low-end of our 2023 constant currency revenue and now expect growth of 5% to 6.25%. Turning to foreign exchange. We now assume a foreign exchange translation headwind of approximately 35 basis points in 2023. Our prior guidance of a 50 basis point headwind for 2023 assumed a $14 million negative impact of foreign exchange for the full-year, of which $17 million was expected in the first quarter. The actual first quarter headwind was approximately $4 million less than was expected. Our revised foreign exchange guidance for 2023 captures the actual rates for the first quarter while the foreign exchange assumptions set at the beginning of 2023 remain unchanged for the balance of the year. Considering the revised foreign exchange headwind, we expect reported revenue growth of 4.65% to 5.9% in 2023, implying a dollar range of $2.921 billion to $2.956 billion. We are reiterating our 2023 guidance for adjusted earnings per share of $13 to $13.60. We are lowering our GAAP adjusted earnings per share outlook to $8.14 to $8.74, primarily due to a one-time tax item. All other elements of our adjusted financial guidance for 2023 remain unchanged, including our outlook for adjusted gross and operating margins. That concludes my prepared remarks. I would now like to turn it back to Liam for closing commentary.
Liam Kelly:
Thanks, Tom. In closing, I will highlight our three key takeaways from the first quarter of 2023. First, we started 2023 with a strong performance as momentum continued from the end of last year. We executed well across our global business and continued to effectively manage the macro headwind. Second, the solid first quarter performance keeps us well positioned to deliver on our financial guidance for 2023. We see an increasingly stable environment for health care utilization. In turn, we expect improving performance of our high-growth portfolio as we move through 2023 in addition to continued strength in our durable core. Third, importantly, we will continue to focus on our strategy to drive durable growth. We will invest in organic growth opportunities and drive innovation, expand our margins and execute on our disciplined capital allocation strategy to enhance long-term value creation. That concludes my prepared remarks. Now I would like to turn the call back to the operator for Q&A.
Operator:
Thank you. [Operator Instructions] Our first question today comes from Cecilia Furlong from Morgan Stanley. Cecilia your line is open. Please go ahead.
Cecilia Furlong:
Good morning and thank you for taking the questions. Liam, I wanted to start just some of your comments on what you're seeing from a recovery standpoint, hospital versus ASC and an office-based setting. But specific to UroLift, can you just speak to what you've seen, where you are from a recovery standpoint in the hospital setting versus ASC office based? And then how do you look through the balance of the year to relative to that 8% to 9% longer-term CAGR for the business? How do you look at where you are today and tracking relative to that growth rate?
Liam Kelly:
Thanks for the question, Cecilia. So I will start at the macro level for overall procedures. Obviously, delivering 13.2% growth in Q1 was ahead of our expectation. Ex the days that came in over 7%, we're really pleased with the first quarter when our guide at the midpoint was approximately 6%. Overall procedure volume within the hospital has continued to move forward and to progress. We're seeing that in particular in the Americas and in EMEA. And what we see overseas in APAC is a strong environment. And we see, especially as you got through March, we saw China start to pick up. For UroLift specifically, we saw growth again in the hospital side of service, which is encouraging. This is now a sequential quarters of growth in the hospital side of service. In the office side of service, it did show some modest improvement, but it is still challenging due to staffing issues and obviously, due to patient flow. And just investors familiar with Teleflex will realize that the patient flow dynamic really started to have an impact as you went into the latter half of the year. It began as you went through Q2 into Q3. So we would still anticipate an improving environment for UroLift as we go through the year. Within the quarter, UroLift came in as expected in the first quarter of this year, and we feel that we're building good momentum. We had a really strong presence at AUA, and we're encouraged by the enthusiasm we see from urologists.
Operator:
The next question comes from Shagun Singh from RBC. Shagun your line is open. Please go ahead.
Shagun Singh:
Great. Thank you so much for taking the question. So your 2023 revenue guidance, it implies a step down in growth for the balance of the year. So what is driving that outlook? Is it conservatism? Or is there anything else to call out? And how should we think about the cadence for the balance of the year? Also, as we look at EPS, you held EPS despite the Q1 beat. I'm just wondering if there are any P&L offsets to consider due to which you didn't narrow the EPS range?
Liam Kelly:
Okay. I'll ask Tom to comment on the EPS in a moment. I'll answer your question regarding the revenue. Shagun, we were very clear in the first quarter that our plan is front-end loaded. And if I'm an investor, I would want to have a front-end loaded plan from a company rather than a back-end loaded plan for a company. There are a few dynamics that play into that in certain parts of our businesses. Obviously, as we go through the year, we have some tougher comparables as you get into the back half of the year. Obviously, this is a day's impact. You've got five additional days in the first quarter. You've got five less days in quarter four. But we feel really good about the full-year. Starting off strong gives us increased confidence in our ability to deliver on our guidance as we go through the year. And also, it's one quarter. It's the first quarter of the year. It's great to have a good solid start. We'd like to get another couple of quarters tucked under our belt, and then we'll see where we land. But we do feel there is an increased momentum behind Teleflex and our momentum within the marketplace just based on the procedural dynamic based on some of our key business units and regions performing exceptionally well. Businesses like OEM, Interventional Access had really strong margins at the month of March. It's really good to see Vascular get back to growth as expected. We told investors that Vascular will get back to growth. It's great to see it getting back to growth. The high-growth portfolio had a really solid first quarter. And durable core, as expected, outperformed in the first quarter just due to that whole procedural volume. I'll ask Tom to discuss briefly the other part of your question around EPS.
Thomas Powell:
Okay. Just as it relates to EPS. So keep in mind that, first of all, we didn't provide quarterly EPS guidance for the first quarter. And in the quarter, our EPS results came in very much in line with our internal expectations. So we remain very confident in the full-year EPS guidance outlook and are very pleased with how the first quarter turned out. So I would say that, as Liam mentioned, stay tuned and we'll continue to monitor the situation. But I feel very, very good about how the quarter played out.
Operator:
The next question comes from Kris Campbell from Jefferies. Kris, your line is open. Please go ahead.
Kris Campbell:
Hey, how are you doing? This is Kris on for Matt Taylor. You touched a little bit on UroLift growth. I was wondering if you could dig a little bit deeper on the high-growth portfolio and some of the trends you're seeing there, including the Standard Bariatrics acquisition?
Liam Kelly:
Yes, absolutely. Chris, thanks for the question. So I will tell you that Titan had a really strong start to the year. We still expect to do $30 million, $35 million. MANTA came in online is on track for the full year. Hemostats did really, really well in the first quarter. It came out of the blocks, passed an intraosseous and did in line. And PICCs, great to see PICCs come back to growth. As we told investors, once the Tyvek situation started to get better, we would expect PICCs to return to growth, and that's exactly what happened within the quarter. PICCs came back very solid performance, and we would expect that to continue as we go through the year. I would anticipate many of the parts of the high-growth portfolio to continue to accelerate as we go through the year. That would speak to UroLift, MANTA, Titan, the PICCs and also some of the intraosseous portfolio. So that would be our expectation, and that's what's contemplated within our guide.
Operator:
The next question comes from Mike Matson from Needham & Co. Mike, your line is open. Please go ahead.
Mike Matson:
Yes, good morning. Thanks for taking my questions. So I wanted to ask one on UroLift. Just did you see the same degree of selling day impact there that you saw in the rest of the business? Because if you did, I would sort of imply a fairly decent decline again there, kind of mid-single digits, I think. Or is there some reason that didn't benefit UroLift?
Liam Kelly:
Yes. So Mike, the days impact for UroLift is similar to the rest of the business. So that would -- you're absolutely correct, that would show some modest decline. But Mike, that's what we were expecting in the first quarter, and it came in exactly as we would have anticipated. We did get some analysis on the days impact. We have it through January and February -- pardon me, on the patient flow impact, and we have it through January and February. And through the first two months of the quarter, patient flow declined by another 3.7%. As we go through the year, Mike, what we will anticipate seeing is getting over the tough comparable on patient flow. As I said a little earlier, the patient flow dynamic really started to get notably worse in 2022 as you went through the year, beginning in Q2 and Q3, where we had double-digit declines in patient flow. Once we get through that comparable, we would anticipate, as we go through the year, an improving environment for UroLift.
Mike Matson:
Okay. I understand. And then just the MSA headwind. Can you just quantify that for us again, just as a reminder, so we can make sure we incorporate that correctly into our models?
Liam Kelly:
Yes. The MSA headwind, as you go from ‘23 into ‘24 is approximately $70 million, Mike. So -- but that's low margin revenue going away. So you lose the $70 million in revenue. But as you go down through the income statement, you will pick up approximately 100 basis points on gross margin as a result of that MSA going away. And of course, that was the whole idea of Teleflex pruning in order to grow the respiratory assets were lower growth assets, there were lower margin assets. And now the investors will see the benefit of that in 2024 as we -- that complete low-growth area has gone out of our portfolio, the MSA has gone out of our portfolio, and you'll see an impact on gross margins and a chunk of that dropping through to op margins in ‘24 as well.
Operator:
The next question comes from Jayson Bedford from Raymond James. Jason, your line is open. Please go ahead.
Jayson Bedford:
Good morning. Just a couple of questions here. OEM And Interventional were quite strong with outsized growth. I just want to make sure there's no kind of one-timers in there. And then just secondly on OEM, you mentioned pretty good visibility through '23. What kind of growth are you looking at from this segment? Thanks.
Liam Kelly:
So our OEM business had a stellar start, 34.5%. Obviously, you've got to take some -- the days impact out of that. It was across the board. We were really strong on catheters. We were really strong in extrusion. Sutures performed very well. The acquisition we did a couple of years ago, HPC, continues to perform exceptionally well and allow us to sell some of our products through to other customers. We would still expect the OEM business to be high single, low double-digit grower, probably now leaning more to the low double digits, given this really strong start to the year. They had a really nice March performance, came in a little bit better than we were expecting. And they did have a prior year easier comp in Q1, which helped them. But the momentum that they carried in from Q4 continued into Q1 and is performing exceptionally well. And candidly, OEM has been performing exceptionally well for the last 3 years now. This isn't just a one quarter phenomenon, even though it's a little bit better this quarter. Within Interventional Access, again, a very strong performance over 23% growth. The return of Langston really has complex catheters, the GuideLiner, TrapLiner, Turnpike performed well. A lot of procedural volume bring us through there. As we go through the year, they -- in Q3, they'll comp the Langston return to the market. But notwithstanding that, this is going to be a nice, solid growth driver, really good margins. And as we went through in our prepared remarks, a really nice setup with new products coming through with the GuideLiner Cost, with the Watson, with the Ringer and with the Triumph now coming to market. So the lifeblood of this business in the past has been new products. And we -- some of the changes we made in our R&D processes have really started now beginning to show bear fruit, as you heard during my prepared comments. So OEM and IA, you're right, Jayson, are the ones that kind of really drove the upside from the expected 6% to 7% within Q1.
Lawrence Keusch:
And the visibility in OEM.
Liam Kelly:
Visibility in OEM is, sorry. Thanks, Larry. Visibility on OEM, it's one of the businesses where we have the longest visibility. So I see a very stable environment for that business over the next period of time.
Operator:
The next question comes from Anthony Petrone from Mizuho. Anthony, your line is open. Please go ahead.
Anthony Petrone:
Thanks, good morning, everyone. Maybe Liam or Tom, just high-level comments on procedure volumes. Certainly, we saw it in Vascular and Interventional, a lot of data points in the quarter that we've certainly gotten to a new level for procedure volumes in particular. Not necessarily that staffing issues have improved to normal, but that workflow at hospitals has improved. So maybe just a little bit on the sustainability of procedure volumes broadly as it relates to the other businesses in the hospital, not specifically outpatient. And then I'll have a follow-up as well. Thanks.
Liam Kelly:
Yes, Anthony, I mean, obviously, within the quarter, growing 7% coming off a Q4 at 4.3% and a full-year last year adjusted at 4.3%. You can see the progress. I mean it's more than just procedural volumes. A lot of the new products that we're talking about are building momentum within the business. Obviously, having standard bariatrics and the Titan product is helping us. But I've been saying this for many quarters now. If you're in the hospital over the last period of time and I think it's going to be sustainable for sure over a number of quarters, procedural volume is really strong. There's a lot of impetus to get procedures done. We're seeing it broadly within EMEA and within the Americas. And as I said a little earlier, with China coming back on stream, we would anticipate getting additional growth out of procedure volume coming through from that lockdown practice within APAC and specifically within China. Regarding staffing, it's not back to where it was. It would be my observation, but it is getting better and better and better every quarter. And I think to your comment about the other sites of service. Once it gets better in the hospital, we will see that go through to the ASC and the office in the near term. And I think it's very encouraging what we're seeing in the hospital side of the service. So I see it as pretty sustainable over a multi-quarter period, Anthony, but I wouldn't want you to go away I think it's just procedural volume. There are some things that we're doing uniquely within Teleflex that's driving a lot of our momentum as well.
Anthony Petrone:
That's great. And then the follow-up would be maybe just your views here most recently on the M&A environment. We're seeing transactions come through within the space. Maybe just updated thoughts on valuations? And then just also the cost of funding. I mean, how does that change the equation now just where the debt markets are when Teleflex thinks about M&A? Thanks.
Liam Kelly:
Yes, Anthony. So we're very active within the market. Our leverage is now 1.7 times. So we have the most important thing you need when you're doing M&A, we have firepower. So right now, we would have the potential. I'm not saying we're going to do this, but we would have the potential to put up to about $2 billion worth of capital to work. We are really active in all areas of M&A. Really happy with Standard Bariatrics having brought that in. And I think that we are looking at tuck-ins. We're looking at scale. We're looking at late-stage technologies across the board. I'll talk a little bit about the cost of funds, but maybe I'll ask Tom to add a comment as well. But I think what we're seeing is the cost of funds is improving somewhat. So the environment we think is a little bit better than it was even a number of months ago. And with regard to valuations, I think valuations are where they were over the last number of quarters. They've come back from the heady days halfway through 2021. And I think it's an environment that's very attractive to Teleflex. But Anthony, we will continue to be disciplined. Investors should know that when we do announce a deal and we bring something into Teleflex, we've done our appropriate work and it's the right deal for Teleflex. Anything you want to add on the cost of funds, Tom?
Thomas Powell:
Well, I was just going to say that, yes, while certainly, the cost of funds are up from where they were a couple of years ago or just a year ago, they're still fairly reasonable levels overall based on where we're currently looking at as a cost of funds relative to where it's been over the past 10 years or 20 years. So I don't believe right now that, that will be an inhibitor to our ability to identify assets. So right now, our focus is really as we input on finding the right strategic fit that makes sense for us and the cost of funds will certainly be a component, but not a limiting component.
Operator:
The next question comes from Craig Bijou from Bank of America. Craig, your line is open. Please go ahead.
Craig Bijou:
Good morning, guys. Thanks for taking the question. I wanted to touch on margin. Obviously, you raised revenue guidance, but the margin guidance didn't change. So I wanted to see if you could walk through the cadence of gross margin operating margin throughout the year. And then given the Q1 performance in both gross margin and operating margins seem to be better than the prior year, which is trending ahead of your overall guidance for '23. So why couldn't we potentially see upside to your margin guidance? And what are some of the things that we should be considering with margins for the rest of the year?
Liam Kelly:
Yes, Craig, thanks for the question. I think one thing I would just like to point out is it's May. So it's very early in the year. We're really happy with the start that we had to the year, both on revenue, on margins and on earnings. My mother, God rest her, used to say a good start is half the battle, and we've had a good start. But I'll let Tom give you a little bit more details on some of the margin impacts, if you don't mind, Tom.
Thomas Powell:
Sure. So on the gross margin front, you should expect to see a pretty stable gross margin throughout the remainder of the year. It will move up and down, but not significantly from where it is right now. On the op margin, what you should expect to see is a sequentially improving operating margin as we go throughout the year. A couple of things you probably want to keep in mind is that as you look at the kind of comparison to prior year or for the gross margin, we had a more favorable comp in the first quarter than we're going to have for the balance of the year. So when looking at year-over-year comparisons, that certainly comes into play. We also are expecting foreign exchange headwinds on gross margin as we go throughout the year. In the first quarter, we actually had a nice benefit. But if you recall last year, the dollar moved significantly beginning in the second and third quarters. And as a result, that's going to prove to have a more difficult comparison. So those are some of the factors I think about. But again, gross margin is pretty stable throughout the year and operating margin will show sequential improvement.
Operator:
The next question comes from George Sellers from Stephens. George, your line is open. Please go ahead.
George Sellers:
Hey, good morning. Congrats on the quarter and thanks for taking the question. I guess maybe a smaller question on the Titan stapler. I know it's still a relatively small piece of the business. But with the Gore buttress material, what are some of the implications on the gross margin for that device? And also for the manufacturing of that, is there an opportunity to, over time, bring that in-house? Thanks for the question.
Liam Kelly:
Yes, George, thank you very much. So first of all, I'd say we're really pleased with the performance of Titan in the first quarter. It drove a lot of the positivity on the surgical business and saw our surgical business perform really, really well. As a result, coming in at 14% growth, the buttress material will have no impact on the margin expectations for this business. We still expect this business as we go through ‘24 become accretive to Teleflex's gross margin and then to really leverage thereafter. Our expectation is to continue to have this parity or have this product manufactured by -- in the -- as we have right now, and we have no plans to make any changes to that at this stage. Obviously, it's ramping pretty rapidly. We don't want to disrupt it. And the third party that we're working with is incredibly reliable and really doing a solid job. So long may that continue, and we'll continue to ramp this product through this year, and we still expect it to do $30 million to $35 million in revenue this year. And that volume will help us obviously leverage the gross margin as we go into '24, George. And thanks for the question.
Operator:
[Operator Instructions] And the next question comes from Mike Polark from Wolfe Research. Mike, your line is open. Please go ahead.
Mike Polark:
Good morning. Thank you. Maybe follow-up there on Standard Bariatrics. And if you said it, I missed it. But can you quantify revenue contribution in the quarter? I know what the full year outlook is for 2023. But I just want to understand where 1Q started so we can have a better sense for the ramp through the rest of the year?
Liam Kelly:
Yes, Mike, we don't break it out specifically in revenue terms. Obviously, we are confident on the $30 million to $35 million for the product. And I will tell you, as I said a little earlier, it is one of those products that will continue to ramp as you go through the year. But again, we had a really nice start in quarter one. So therefore, it reinforces our confidence on the $30 million to $35 million for the full-year, and the product is performing very well. We actually showed it at Sages, and we had a lot of really, really positive feedback from the product at Sages. It is addressing a lot of the unmet needs that bariatric surgeons has. And the buttress that we're adding to it just overcomes one of those hurdles. Some surgeons just like to use buttress when they're sealing. And it's probably not as much needed with the Titan as it is with the other technologies. But if that's the process they want to use, then we're going to support them in doing that. So I think that it all bodes well for the Titan over a multiyear period.
Mike Polark:
If I can follow-up, my other topic was Tyvek. If memory serves, I thought maybe the second half of the year is when that situation might get a little bit better for the industry. It sounds like it's improving in real time. So what's driving that? Are you just seeing kind of more supply come online and how -- was it kind of -- how has it trended? And are you back to normal there or pretty darn close? Any kind of framework for where we are? And then the related question is, can you just remind us the revenue, the segment lines that are most impact -- have been most impacted by that situation, and so the comps are -- where the comps are easiest as that -- as supply improves. Thank you.
Liam Kelly:
Yes. I'll use your expression. It's pretty darn close to getting back to normal. It's not quite back to normal yet, Mike, but it is moving positively in the right direction. And it is better than we had anticipated in the first quarter. You are correct. Once we get to the back half of the year, new supply comes on from the provider of Tyvek, and that will eliminate the issue. The two lines that are impacted, the two is really in our Vascular business. It's to a lesser extent, our CVCs because we prioritize the supply, we had to keep our market share position in CVCs. What it has done, it has prevented us from converting PICC accounts. And as you heard in my prepared comments, it was nice to see PICCs getting back to double-digit growth in the quarter as we're able to go back out and start converting those accounts. Just to remind investors, our PICC portfolio is unique in so far is that it has an antimicrobial and an anti-thrombogenic coating. So therefore, that's why we're getting broad adoption for that portfolio globally and in particular, in the United States, where we're not the market leader, we see a great opportunity to continue to take share.
Operator:
The next question comes from Richard Newitter from Truist. Richard, your line is open. Please go ahead.
Richard Newitter:
Hi, thanks for taking the question. Just one for me. On UroLift, I guess, the comments about still some lag on patient flow. I guess, even some of the other subcategories in med tech that improved, but are lagging things, like elective procedures, like knees and hips, even those kind of saw some of the patients coming back into the channel for doctor visits and things of that sort. I'm just curious, is there anything specific about UroLift that contrast to some of those other procedures, not UroLift, sorry, but the doctor visit and patient flow? Just trying to get a sense for why maybe certain neurological procedures like this would be still lagging to such an extent versus the rest of the kind of the med tech environment. Thanks.
Liam Kelly:
Well, there's a couple of things I'd point out, Rich. First of all, when you're doing hips and knees, you're not doing them to urology patients. So it is unique to the urology specialty. There's a few things with urologists. The average age of urologists within the United States is 55. So it's an aging demographic for the delivery of care. And it's -- we're probably more exposed to the office side of service than any of the hips and knees guys or any other -- or even any of our peers in the urology call point. As investors familiar with Teleflex will know, about 30% of our UroLift revenue is generated within the office. And I can tell you that the data that we have will tell us that patient flow declined 3.7% through January and February. Now the good news, Rich, is that once we get into the latter half of the year and we progress, the toughest comp on patient flow will be behind us as we go through the year. So we do anticipate an improving environment from that perspective. And it was almost palpable the enthusiasm for UroLift with urologists at AUA. I was there in Chicago earlier this -- in late April. And compared to a year ago, there was way more attendees. It really felt good. It was buoyant. We had a lot of education seminars with a lot of podium presence at that. And it was almost it was back to the good old days of UroLift, I would say, at that conference. So we do anticipate somewhat of a bounce from that, and we do anticipate the back half of the year being better.
Operator:
[Operator Instructions] As we have no further questions, I'll hand the call back to Lawrence Keusch for any concluding remarks.
Lawrence Keusch:
Thank you, Adam, and thank you to everyone that joined us on the call today. This concludes the Teleflex Incorporated First Quarter 2023 Earnings Conference Call.
Operator:
This concludes today's call. Thank you very much for your attendance. You may now disconnect your lines.
Operator:
Good morning ladies and gentlemen and welcome to the Teleflex Fourth Quarter 2022 Earnings Conference Call. At this time, all participants have been placed in a listen-only mode. At the end of the company's prepared remarks, we will conduct a question-and-answer session. Please note that this conference call is being recorded and will be available on the company's website for replay shortly. And now I'll turn the call over to Mr. Lawrence Keusch, Vice President of Investor Relations and Strategy Development.
Lawrence Keusch:
Good morning everyone and welcome to the Teleflex Inc. fourth quarter 2022 earnings conference call. The press release and slides to accompany this call are available on our website at teleflex.com. Please note that webcast viewers have the ability to advance the presentation slides on their own. Simply follow along with the presentation as we proceed through the call. As a reminder a replay will be available on our website. Those wishing to access the replay can refer to our press release from this morning for details. Participating on today's call are Liam Kelly, Chairman, President, and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks and then we will open the call to Q&A. Before we begin I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in the slides posted to the Investor Relations section of the Teleflex website. We wish to caution you that such statements are in fact forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today, as well as our filings with the SEC included in our Form 10-K which can be accessed on our website. During this conference call, you will hear management make statements regarding intra-quarter business performance. Management is providing this commentary to provide the investment community with additional insights concerning trends and these disclosures may not occur in subsequent quarters. With that said, I will now turn the call over to Liam for his remarks.
Liam Kelly:
Thank you, Larry and good morning everyone. For the fourth quarter, Teleflex revenues were $758 million, a year-over-year decline of 0.5% on a reported basis and an increase of 3.7% on a constant currency basis. Compared to the prior year period, revenue under the manufacturing and supply transition agreement associated with our prior divestiture of our Respiratory assets negatively impacted growth by 0.6% in the quarter, implying underlying constant currency growth of 4.3%. Adjusted earnings per share declined by 2.2% year-over-year to $3.52. In reviewing the quarter, our fourth quarter constant currency revenue growth remained durable despite an unexpected subcomponent supply chain issue in our Surgical business that resulted in an approximately $3.5 million headwind during the quarter. The solid performance in the quarter continues to demonstrate the benefits of Teleflex's diversified portfolio that has been purposely built to target the care of critically-ill patients. Of note, our Interventional Surgical and OEM product categories generated double-digit constant currency year-over-year revenue growth during the fourth quarter. Encouragingly, we witnessed improving monthly growth on a sequential basis with December representing the strongest month of the quarter as health care utilization continues to normalize. From a geographic perspective, Asia generated strong results and continues to be an important growth driver for Teleflex. Raw material inflation and supply chain challenges remained headwinds for the business during the fourth quarter. Tyvek continues to be in short supply and has primarily impacted our Vascular and Interventional businesses. Turning to the full year of 2022. When adjusting for the divestiture of the Respiratory assets and one less shipping day, constant currency revenue growth was 4.3% for 2022 as healthcare utilization improved through the year and demand for Teleflex products accelerated. Our high-growth revenue portfolio maintained momentum across the majority of growth drivers. Although UroLift constant currency revenue declined 5% year-over-year in 2022, the remainder of products in the high-growth portfolio continued to show healthy gains with approximately 14% constant currency growth for the year. Moving over to durable core revenues. In 2022, durable core revenue grew approximately 5% on a constant currency basis as compared to the prior year period, reflecting improvement in procedural volumes, strong global execution, new product introductions and positive price. Our other category which includes our Respiratory and drainage catheter business as well as revenue from the MSA, we entered into with midlines in connection with the sale of our respiratory business declined just under 10% year-over-year in 2022. Now, let's turn to a deeper dive into our fourth quarter revenue results. I will begin with a review of our geographic segment revenues for the fourth quarter. All growth rates that are referred to are on a constant currency basis unless otherwise noted. Americas revenues were $458 million which represents 1.7% growth year-over-year against a tough comp in the year ago period. Excluding the impact of the year-over-year decline in MSA sales, Americas revenue grew 2.7% in the quarter. Interventional and Surgical recorded double-digit growth offset by declines in other areas of the business including Interventional Urology. EMEA revenues of $147.8 million increased 1.4% year-over-year. We continue to see procedure volumes improve year-over-year. Now turning to Asia. Revenues were $78.5 million increasing 13.3% year-over-year. We saw strength across the region with all geographies posting solid growth during the fourth quarter. China growth approached 7% despite COVID-associated disruptions towards the end of the quarter. Let's now move to a discussion of our fourth quarter revenues by global product category. Commentary on global product category growth for the fourth quarter will also be on a constant currency basis. Starting with Vascular Access. Revenue increased 0.5% to $186.4 million. As we anticipated, the performance in the quarter demonstrated a return to growth for Vascular Access despite a tough comp per central venous catheters due to the year-over-year reductions in COVID patients in intensive care units in the United States. Although we made sequential progress on back orders, supply chain is still not yet back to normal. As previously discussed, the vascular business has the greatest exposure to Tyvek packaging for our kits and trays. Tyvek shortages are anticipated to improve in the second half of 2023, as additional supply for the industry comes online. Over the long-term, we remain confident that our category leadership in central venous catheters and midlines along with our novel coated PICC portfolio continued to position us for dependable growth. Moving to Interventional Access. Revenue was $125.1 million, up 13.4% year-over-year. We saw sequential improvements in constant currency revenue growth through 2022 as procedures moved back to pre-pandemic levels. In the quarter, our diversified portfolio served us well with Balloon Pumps, OnControl and MANTA all contributing to growth. Turning to Anesthesia. Revenue was $99.6 million up 2% year-over-year. Of our larger franchises hemostatic products, LMA single-use masks and endotracheal tubes all had strong performances in the fourth quarter, partially offset by regional anesthesia. In our Surgical business, revenue was $110.4 million representing another solid performance with 10.4% growth year-over-year, despite the aforementioned supply chain disruption due to a specific subcomponent supplier. Among our largest product categories, skin stapling and our ligation portfolio contributed to growth. In other developments, we closed the acquisition of Standard Bariatrics early in the fourth quarter and Titan Stapler revenue drove a significant portion of the year-over-year growth in the Surgical business. For Interventional Urology revenue was $89.2 million, representing an increase of 13.1% sequentially and a decrease of 3.6% year-over-year. Interventional Urology continued to be impacted by a year-over-year decline in patient visits to urologists and staffing shortages. Although, the overall environment for elective BPH procedures has not yet returned to normal, there were signs of improvement during the fourth quarter. Third-party data indicates that overall patient business to urologists were down in the 3% to 4% range year-over-year in the fourth quarter, which marks a sequential improvement from the high single-digit year-over-year decline witnessed in the third quarter of 2022. OEM revenues increased 12% year-over-year to $73.7 million despite a very difficult comparison to last year. Our order book remains well positioned, as customers recognize our broad competencies with competitive capabilities, including fast growth markets for thin walls interventional microcatheters to access small vessels and fine wire for sensing and ablation technology. Fourth quarter other revenue declined 7.1% to $73.6 million year-over-year. We continue to expect all MSA revenues to cease at the end of 2023. That completes my comments on the fourth quarter revenue performance. Turning to some commercial and clinical updates. As mentioned earlier we completed the acquisition of Standard Bariatrics early in the fourth quarter of 2022. Standard Bariatrics commercialized the Titan SGS Stapler for use in sleeve gastrectomy procedures to treat morbid obesity, and we are excited to have the product in the Teleflex Surgical portfolio. We are proceeding with our integration activities and remain on track with our objectives. Of note, we have completed the training of the Teleflex sales force on the Titan Stapler enabling us to double the size of the selling organization as compared to Standard Bariatrics on a stand-alone basis. We also recently announced that Teleflex was rewarded a group purchasing agreement with Premier for the Titan Stapler. The agreement will make the Titan Stapler available to surgeons affiliated with Premier and provide access to this innovative technology for use in gastric sleeve surgeries. Turning to UroLift. We reached our objective to convert the vast majority of users to UroLift two during 2022, which will free up time for our sales organization to dedicate increased time to market development activities in 2023. Training of new physicians continued in the fourth quarter, and we reached our targets for the year. Of note, the number of physicians trained in 2022 remains largely consistent with historic levels implying continued interest in adding UroLift to the BPH treatment paradigm. To support new physician onboarding for UroLift we hosted live BPH summit training sessions in the US, Australia and Japan during 2022. Our direct-to-consumer program remains an important investment and achieved its pre-specified performance metrics for 2022. We will continue to invest in DTC initiatives for UroLift including a refreshed television and digital campaign that launched in February of 2023. Now moving to an update of our international strategy for UroLift. We made considerable progress in the geographic expansion for UroLift with entry into several new markets during 2022 including Japan and China. Starting with Japan. We had strong launch execution with UroLift gaining sequential traction through 2022. Revenues exceeded our expectations for the year, and we see continued momentum into 2023. Turning to China. We initiated UroLift cases in the fourth quarter as anticipated. We will be methodical in our launch activities and follow a similar playbook to the one that has served us well in Japan. In turn, we will spend 2023 training surgeons, building our presence in key cities and continuing to engage with the Chinese Urological Society to build acceptance. Now for an update on Vascular business. The Vascular business unit continues to align its portfolio and clinical education offering with the evolving customer needs. Today, Teleflex is well-positioned to serve as a trusted partner with Vascular access clinicians in their goal of zero catheter-related complications. We are helping to standardize outcomes by providing protection during and after vascular access procedures and establishing a predictable insertion process across the hospital. This approach continues to solidify our significant market share in CVCs and drive revenue growth through the highly successful launch of the CVC ErgoPack complete portfolio offering a complete vascular access insertion system designed to help clinicians comply with current guidelines and standards. We also continue to prioritize growth in the PICC and midline categories with the most recent advancement being the launch of the new Arrow Pressure Injectable Midline portfolio in North America in the fourth quarter of 2022. The new offering is designed to help alleviate risk associated with line misidentification. Without quick and easy identification between midlines and PICCs, medication may mistakenly be infused through midlines that should only be infused through a central venous access device potentially causing complications and disruption in patient therapy. We are still in the early phase of the launch, but have seen a great level of interest from customers thus far. Additional innovation and PICC placement and positioning devices can be expected in 2023 as we continue to drive toward growth and share gain in this segment. Turning to the Interventional Access business. I am pleased that the relaunch of the Langston catheter has progressed through the fourth quarter with product availability in the US, Canada Australia and New Zealand. The Langston catheter is a unique diagnostic tool that has clinicians determine the degree of aortic stenosis, which might result in a subsequent TAVR procedure. Our clinical and medical affairs team works to reeducate the market on this product including through a panel discussion at TCT and a webinar held in December. The Langston catheter continues to build value for our customers, enhance our engagement with clinicians in TAVR and demonstrates our relevance in the structural heart space. We expect further product launches in our interventional business over the coming years; including complex catheters in the structural part market. Finally, some comments on the outlook for 2023. We witnessed improving stabilization in healthcare utilization over the course of 2022 and would expect a further sequential stabilization in healthcare utilization in 2023. Indeed the majority of the procedure markets that we serve are now back at or above 2019 levels. Conversely, some of the more deferrable disease states reflects patient visits to physicians that remain below pre-pandemic levels including urology. We anticipate that as COVID has become increasingly endemic and staffing shortage bottlenecks gradually ease patients will increasingly seek medical interventions during 2023. Turning to the macro environment. 2022 had its share of operational challenges including inflation and supply chain disruptions. For 2023, we are prepared for some level of continued volatility although we would expect incremental inflation to be at levels lower than 2022 and supply chain challenges to improve through the year. We remain focused on our global operations and we'll look for ways to become more efficient as we work through the macro environment. That completes my prepared remarks. Now I would like to turn the call over to Tom for a more detailed review of our fourth quarter financial results. Tom?
Thomas Powell:
Thanks, Liam and good morning. Given the previous discussion of the company's revenue performance, I'll begin with margins. For the quarter, adjusted gross margin totaled 60% a 120 basis point increase versus the prior year period. The year-over-year increase was driven by price, foreign exchange and mix partly offset by incremental inflation. Of note, our price strategy maintained its traction during the fourth quarter, enabling us to drive more than 50 basis points of year-over-year price improvement for 2022. During the quarter, we continued to see an improvement in sea freight costs in line with our expectations. Conversely, raw material and supply chain disruption remained elevated and have yet to normalize. Adjusted operating margin was 27.9% in the fourth quarter. The 30 basis point year-over-year increase was the result of higher gross margin and disciplined expense management of non-revenue-generating expense, partly offset by deleverage across our expense base from lower revenue year-over-year; inflation in our expense base such as wages; and planned investment in the business for our growth drivers. Net interest expense totaled $18.7 million in the fourth quarter, an increase from $11.8 million in the prior year period. The year-over-year increase in net interest expense reflects higher interest rates versus the prior year and increased borrowings on our revolver to fund the purchase of Standard Bariatrics, partially offset by a reduction in average debt outstanding. Our adjusted tax rate for the fourth quarter of 2022 was 13.6% compared to 13.8% in the prior year period. The year-over-year decrease in our adjusted tax rate is primarily due to further enhancements and tax efficiencies and of our global structure, partly offset by tax expense arising from the new provision of the US tax law requiring the capitalization of certain R&D expenses. At the bottom line, fourth quarter adjusted earnings per share was $3.52, a decrease of 2.2% versus prior year. Turning now to select balance sheet and cash flow highlights. Cash flow from operations for 2022 was $342.8 million compared to $652.1 million in the prior year period. The decrease was primarily due to lower operating results, higher tax payments, higher payroll and benefit-related payments, and unfavorable changes in working capital driven by an increase in inventory purchases to maintain high customer service levels during a period of elevated global supply chain volatility. Moving to the balance sheet. Our financial position remains healthy. At the end of the fourth quarter, our cash balance was $292 million as compared to $445.1 million as of year-end 2021. Reduction in cash on hand is due to $240 million of payments on our senior credit facility and $73 million for the acquisition of Standard Bariatrics. Additionally, we borrowed $100 million under the senior credit facility for the Standard Bariatrics acquisition. Net leverage at quarter end was approximately 1.8 times, which remains well below our 4.5 times covenant. Now turning to our 2023 guidance update. We expect 2023 constant currency revenue growth of 4.75% to 6.25%. Foreign exchange is expected to be a headwind of approximately 0.5 point in 2023. Considering the foreign exchange headwind, we expect reported revenue growth of 4.25% to 5.75% for 2023, implying a dollar range of $2.91 billion to $2.952 billion. We continue to expect revenue from Standard Bariatrics to be within a range of $30 million to $35 million. Turning to the middle of the income statement. We expect gross margin for 2023 to be 59% to 59.5%. Our gross margin guidance range reflects the positive impacts of year-over-year manufacturing efficiencies, product mix and price, largely offset by inflation. Although, we saw a moderation in sea freight costs during the second half of 2022 in line with our forecast, raw material inflation was greater than expected at the time of our May 2022 Analyst Meeting. And for 2023, we have assumed that macro volatility will persist and continued inflation in raw materials, labor and utilities to represent headwinds to our gross margin this year. Moving to operating margin. We expect a range of 26% to 26.75%. Our guidance reflects the flow through of gross margin, headcount and employee related expenses, investments to grow the business and the inclusion of Standard Bariatrics, partly offset by the positive impact of restructuring. Turning to items below the line. We expect an adjusted tax rate in the 10.25% to 10.75% range for 2023. Net interest expense is expected to approximate $67 million for 2023. The majority of the year-over-year increase in our net interest expense outlook reflects higher interest rates partially offset by debt repayment. Moving to earnings. Our adjusted earnings per share guidance for 2023 is $13 to $13.60, which represents a 0.5 point year-over-year decrease at the low end and a 4.1% increase at the high end. When considering your models for 2023 foreign exchange will be a meaningful headwind to revenue in the first half and then increasingly turn to a tailwind in the second half of the year assuming foreign exchange rates as of the beginning of 2023. However as a result of how foreign exchange flows through our inventory, there will be headwinds to EPS through the third quarter and then it would become neutral in the fourth quarter. We also note that while there is no year-over-year difference in the number of shipping days in 2023 versus 2022, there will be five extra shipping days in the first quarter and five less shipping days in the fourth quarter of this year. Historically the benefit or headwind to our year-over-year GAAP revenue growth from a shipping day change is approximately 1% in a fiscal quarter. Although, we do not provide quarterly guidance for your modeling purposes, we would expect a constant currency revenue growth range in the first quarter of approximately 5.5% to 6.5% when excluding the benefit from five extra shipping days of approximately 5%. Finally, I'll provide some commentary on our long-range plan. We remain confident in the foundational pillars of our durable growth strategy that we provided at our May 2022 Analyst Meeting. Our 2023 to 2025 long-range plans remain anchored on discrete drivers for revenue and earnings per share growth as well as margin expansion. We are long-term focused on achieving our objectives for 2025 and continue to see the opportunity to drive greater scale, improve profitability, execution on a disciplined capital allocation strategy and strong cash flow generation for Teleflex. With that said, the macro environment has been highly dynamic and there have been a number of unanticipated headwinds on our business in the period since May 2022 Analyst Meeting. First, in the second half of 2022, Inflation has been persistent and at a higher level than we projected at the time of our 2022 Analyst Meeting, in particular from raw material costs and their related impact on gross margins. Second, although we anticipated a sequential improvement in the procedure environment for UroLift throughout 2022, headwinds persisted through the year. In particular, patient visits to urologists were down year-over-year in 2022 and staffing shortages remained a bottleneck for procedures, especially in the office setting. Third, foreign exchange was a larger headwind than was expected as the dollar strengthened against a broad basket of currencies in the second half of 2022. Interest rates also increased dramatically in the second half of 2022 and are expected to continue rising in 2023. Although, we have not recast the entirety of the LRP provided in May 2022, we have updated assumptions related to inflation, foreign exchange and interest rates. In addition, we are now assuming a 3-year CAGR in the 8% to 9% range for global UroLift revenues. And finally, since we acquired Standard Bariatrics early in the fourth quarter of 2022, we have incorporated the business into the long-range plan. We continue to view the LRP targets provided at the 2022 Analyst Meeting as the vision for Teleflex in 2025. With 2022 as the base year in incorporating the updates, we now believe that we will deliver at the low end of the ranges for 2023 to 2025, total revenue CAGR and margin expansion. For the high-growth portfolio, which represented a little more than 25% of revenues in 2022, we expect approximately 12% to 13% CAGR for the LRP. For the durable core, which represents slightly over 60% of revenues in 2022, we expect to grow at approximately a 5% CAGR. With respect to the remaining portion of the total revenue, which we refer to as the other category, we expect a negative 6% to 7% CAGR due to the LRP. And that concludes my prepared remarks. I'd now like to turn it back to Liam for closing commentary.
Liam Kelly:
Thank you, Tom. In closing, I will highlight our three key takeaways from the fourth quarter of 2022 and our 2023outlook. First, our fourth quarter results were solid and driven by an improving end market for the majority of our businesses. Second, we are confident in our outlook for 2023. Our outlook reflects the diversification of the Teleflex portfolio through the combination of our growth drivers and stability of durable core revenues. Importantly, we will continue to focus on investment in our future growth drivers to enhance long-term value creation. Third, we are focused on achieving our objectives in 2025. We have a balanced approach to top line growth as we invest in our growth drivers and optimize the performance of the durable core. We see opportunities to drive margin expansion through mix shift, restructuring and price. And finally, we will remain disciplined in our capital allocation strategy, with a focus on executing on our M&A strategy. That concludes my prepared remarks. Now, I would like to turn the call back to the operator for Q&A.
Operator:
Thank you. [Operator Instructions] Our first question will come from Cecilia Furlong with Morgan Stanley. Please go ahead, Cecilia.
Cecilia Furlong:
Great. Good morning, and thank you for taking the question. Liam, I wanted to start with '23 guidance and if you could walk through relative to the updated LRP and those CAGRs, how we should think about contributions both from the durable core high-growth assets in UroLift. And specifically on UroLift with the 8% to 9% CAGR, how you're thinking about cadence over the next three years?
Liam Kelly:
Yes. Cecilia, thank you for the question, and good morning. So, I'll start with our overarching guidance for '23 on revenue, which is 4.75% to 6.25% with a midpoint at 5.5%. This represents an improvement over 2022, which had an underlying growth rate of 4.3%. And as regards cadence within the year, you obviously heard in Tom's prepared comments, where the quarter one will be 5.5% to 6.5% with a midpoint of 6%, so therefore, obviously, seeing an improvement right out of the gate in core revenue. As a company, we're continuing to focus our efforts on high growth and durable core, to the other part of your question. But the natural evolution for Teleflex is to guide these buckets as they contribute to the overall growth rate of the company. Our guidance assumption for 2023, Cecilia, assumes that high growth will grow 8% to 11%; durable core will grow 4.5% to 5.5%; and the other bucket will be flat to declining in 2023. As you know, we're an incredibly transparent company. And while we will not be guiding specifically to UroLift, we will report Interventional Urology revenues every quarter consistent with all our other product categories. The exception of this, this year will be Standard Bariatrics and the Titan Stapler, as we have guided the full year $30 million to $35 million. This is consistent with our past guidance principles of giving guidance to an acquisition within the first year. Obviously, for UroLift, we would expect an improving environment in 2023, and that would carry on into '24 and '25, Cecilia.
Cecilia Furlong:
Great. Thank you, Liam. And then if I could follow up on gross margin as well, just the outlook that you put out for '23, if you could walk through both what you're expecting from continued inflation benefit of pricing. And then also just UroLift 2 conversion impact that's having on gross margin alongside Standard Bariatrics?
Liam Kelly:
Okay. I'll just cover the conversion of UroLift 2 and Tom will cover the rest of the topics on margins, Cecilia. UroLift 2 we have the US market pretty converted at this stage to the UroLift 2, and Tom will go through your other questions on the gross margin line.
Thomas Powell:
Okay. So for 2023, our guidance is 59 to 59.5 or about five basis points at the midpoint. And for 2023 we expect to realize meaningful margin accretion from the combination of mix price manufacturing cost improvement programs and our footprint restructuring programs. However as we've spoken about in 2022, we continue to expect inflation largely to offset these gains. And additionally we're expecting a modest gross margin headwind from foreign exchange. If we were to look at what are the drivers of the accretion, the largest being the cost improvement programs accounting for some 40% of the positives and then mix price and the footprint about 20% each of the increase. And then as we look at what is offsetting that, it's largely the inflation, which accounts for 80% of the offset. And then as mentioned it's a little bit from foreign exchange as well and some miscellaneous other items. So really it's a story of really good underlying margin expansion opportunities. As we've mentioned we still feel very good about the long-term prospects. However, inflation is having an impact and largely offsetting those nice gains in the underlying business.
Operator:
Our next question comes from Matt Taylor with Jefferies. Matt, please go ahead.
Mike Sarcone:
Hey, thank you. This is Mike Sarcone on for Matt today. Good morning, everyone.
Liam Kelly:
Good morning.
Mike Sarcone:
Good morning. So just two follow-ups on Cecilia's questions. Just first on the UroLift growth CAGR of 8% to 9% over the next three years. By any chance could you parse out how you're thinking about US growth versus OUS growth?
Liam Kelly:
YeahSo I will tell you that when it comes to the guidance for UroLift during the LRP over the coming years, we are assuming that UroLift will grow 12% to 13%. So, two comments on that. We -- the high growth will go 12% 13%. And within that UroLift will grow 8% to 9%. So a couple of comments on that. First is that nothing has changed to our international assumptions. We still are confident in the rollout of the product in Japan. As we said in our prepared remarks, we've begun in China. There are other geographies coming on board such as Brazil, Taiwan, India, France, Italy, Spain and ultimately Germany as you go through the LRP cadence. I would also say that 2022 played out a little bit differently than we anticipated in the US with procedural recovery a lot slower than we had anticipated due to patient flow and staffing shortages. And I think overarching if you look at Teleflex as a company within that high-growth bucket in 2022, it's 25% of our company growing at 12% to 13% By 2025, it will be one-third of our company still growing at that 12%, 13%. And I think this along with our growth within UroLift will position Teleflex as for attractive long-term durable growth as a company.
Mike Sarcone:
Got it. That's very helpful. And then just one follow-up on the gross margins for 2023. Do you think you could help us think about the quarterly cadence through the year and just how we should flow gross margin through?
Thomas Powell:
Yeah. So I'd say there's some pluses and minuses with how foreign exchange comes in and others. But what you should expect is a relatively stable gross margin for the first three quarters and then expect to see some margin expansion or further expansion in the fourth quarter as a result of a higher volume more attractive mix expectation.
Operator:
Our next question comes from Shagun Singh with RBC. Please go ahead. Your line is open.
Shagun Singh:
Great. Thank you so much for taking the question. So just on UroLift, the LRP guidance is about 8% to 9%. Is mid single-digit a reasonable ballpark for this year? And I just wanted to get your thoughts on what gives you the confidence that patients will return. Do you have a backlog to tap into? It is encouraging that physicians are continuing to train. And then with respect to my second question on EPS, it's a pretty wide range. So what gets you to the top versus the bottom end? And what are the biggest swing factors here? Thanks for taking the questions.
Liam Kelly:
Okay. Shagun, thank you for the questions. I'll let Tom answer the EPS range in a moment, but let me begin with UroLift. So obviously, we feel confident on the 8% to 9% for UroLift within our LRP. We do believe it will be improving, as we go through the LRP. And as I said earlier, nothing has changed in our assumptions for the international markets and we continue to anticipate that the international markets will do well. And we do feel good about the global growth for the UroLift franchise based, on all of that and based on the improving environment that we anticipate, as we said in our prepared remarks. And this gives us the confidence in the LRP growth of 8% to 9% CAGR, between now and 2025. With regard to your question regarding patient returns, there's two elements I think is going to need to be taken into account is, patient returns and staffing shortages. And we have seen -- in the fourth quarter, we saw a 13% sequential improvement from Q3 to Q4. We did see across all of our businesses an improvement, as you went through the fourth quarter as we said in our stated -- in our prepared remarks. That was also true of UroLift, as you went through that fourth quarter. You saw improvements, as you went through the three months of the fourth quarter. I was actually -- and ultimately we beat the UroLift -- our expectations for UroLift, by in excess of $3 million in the fourth quarter, which is the first time we've done that in a couple of quarters now, which gives us some encouragement as we move forward. I was out on the road last week, I spent a few days with our urology sales force with UroLift and meeting with customers. And while we're seeing some improvement in staffing levels in hospitals, we're still not seeing it in the ASC and in the office environment. I do anticipate that that will improve as we go through this year 2023. And I also believe, that patient flow will begin to return to the office. We're going to help that by continuing to train urologists. And we trained close to around 400 urologists, last year. Everything that's within our control, we're managing I think really well. We're going to continue with our DTC campaign. And we have, a new ad that we just launched. And let's not forget BPH isn't going away. 12 million men with BPH, are still there. It's deferrable, but it's not gone. And we remain the premier product for the treatment of BPH. And we are in effect the market leader in the treatment of BPH, which gives us confidence for that CAGR for UroLift over the LRP.
Thomas Powell:
And then with regard to EPS the $0.60 range, which is a little bit less than 5% top versus bottom. So the drivers that could push us to the top end of the range, would be favorable mix in our sales for the year, as well as inflation staying at a certain level. So if I were to characterize, what would be the swing factor in there, probably the largest swing factors can be foreign exchange rates, which have been proven to be pretty volatile over the past year as well as just where does inflation go. So that's -- those are probably, the two biggest swing factors in the guide.
Operator:
The next question comes from Mike Polark with Wolfe Research. Please go ahead, Mike.
Mike Polark:
Good morning. Thank you for taking the questions. I have two on the updated comments around the LRP revenue first and then margin. On revenue, I heard low end the prior CAGR was described as 6% to 7% at the company-wide level. So let's call it 6%. My question is, are there any additional kind of unannounced acquisitions considered in that update. Or is it the base plus Standard Bariatrics now, and no unannounced M&A contribution?
Liam Kelly:
So, Mike, thanks for the question. You are absolutely, correct. It is the base with the revised UroLift CAGR and the inclusion of Standard Bariatrics. That is the only change, we've made. That's accurate.
Mike Polark:
Cool. The follow-up on margin as it relates to the updated LRP commentary, just to level set low end for the prior goals on gross and operating margin expansion, jumping off from 2022. So 2022 on gross margin 59.2. If I add 250 basis points I'm just south of 62% in 2025 and then on operating margin 27% plus 200 bps and 29% in 2025. Have I done the math correct?
Liam Kelly:
You have.
Mike Polark:
Okay. Thank you.
Liam Kelly:
Thanks, Mike.
Operator:
Next question comes from Jayson Bedford with Raymond James. Jason, please go ahead.
Jayson Bedford:
Good morning. So I wanted to ask about operating margin the fourth quarter was strong but the 2023 op margin guidance was a bit softer. And the heaviness seems all to be in the operating line OpEx. It implies a pretty sharp step-up in OpEx and I assume some of the restructuring helps this line. But I guess my question is where is the reinvestment occurring. And how much of this is kind of structural inflation-driven or discretionary?
Thomas Powell:
Well to your point I think as we look at the op margin for 2023, the first point is that just given the inflationary pressures and foreign exchange we're getting a lesser gross margin benefit than we would typically get. So we're starting off with the last benefit from the gross margin. But then, as you look at the OpEx, there's a couple of things that are I guess I would characterize them as structural in that, there are head count-related expenses that we're adding back in – in 2023 that were not there in 2022. Variable compensation was lower than target and there were a number of open positions quite a few that took a while to fill given the tight labor market environment and we're we've filled those positions and we're resetting the variable comp back to 100%. So there's a pretty big structural kind of move as a result of that. Now investments to grow we've got some continued investments behind our high-growth drivers. Expansion into international markets would be one as well as continuing to build out the capabilities of our systems and otherwise in 2023. Now, restructuring does provide a benefit. Part of that is in gross margin, part of it is in OpEx, and some is in 2023 and the balance in 2024 and about two-thirds of that restructuring will benefit 2023. So I would say, overall the biggest impact is just a structural putting the cost back into the OpEx that were not there in 2022. And that's part of the reason why we benefited in 2022 at a higher margin as these costs were not in the cost structure.
Jayson Bedford:
What's the expected dilutive impact from Standard Bariatrics in 2023?
Liam Kelly:
So that's – as we stated before Jayson it's $0.10. So it was –
Thomas Powell:
$0.10 to $0.15.
Liam Kelly:
It is $0.10 to $0.15 for this year and it was $0.10 in the fourth in last year.
Operator:
Our next question comes from Lawrence Biegelsen with Wells Fargo. Lawrence, please go ahead.
Lawrence Biegelsen:
Yeah. Good morning. Thanks for taking the question. One on 2023, one on the LRP. Just on 2023, Tom maybe help me with the math here. The midpoint of the Q1 guidance day adjusted 6%, I think constant currency. It's slightly below the rest of the year. Just why would – why would the growth for Q2 through Q4 be lower than Q1, if I'm doing the math correctly?
Liam Kelly:
So I'll take that one instead of Tom, if you don't mind Larry. So really you have a year-over-year, comp is one of the reasons for it. If you recall, there was Omicron last year which had a slight impact on some of the procedures that we're getting done. We also expect in Q1 to see a good solid performance as – in the overseas markets and in OEMs so – just because of that, impact in the prior year period. So, that's why it's a little bit front-end loaded in that regard Larry. And I think most investors would prefer to see a front-end loaded revenue plans and a back-end loaded revenue plan in my experience at least. So I think coming out of the blocks pretty well at a 6% growth with the guidance that – with the midpoint of our full year guidance at 5.5% I think should be seen as a positive for the investment community.
Lawrence Biegelsen:
Okay. Yeah. So I agree with that on the front-end loaded comment. Liam thanks. And then on the LRP, I guess, maybe two-parts. One, if I'm just thinking about the math right the 5% -- I think the midpoint for revenue, it's about 5% organic this year in 2023, if I'm thinking about that right but 6% now for the LRP. So it implies an acceleration in 2024 and 2025 if I'm thinking about that, right. And on the margins, to follow-up on the earlier question, people are going to now look at this operating margin for example, at 26.3 at the midpoint for 2023 and approximately 29% goal in 2025. That's a pretty big step-up of about 300 basis points. So, basically what gives you the confidence in both of those if I'm thinking about the revenue acceleration in 2024 and 2025 correctly here? And then, on the margins basically 150 basis points a year, in 2024 and 2025. What gives you that confidence? Thanks for taking my questions.
Liam Kelly:
Okay. So I'll cover the LRP, and Tom will cover the margin question. But I know, what Tom's answer is it's going to be really focused on inflation Larry, which should be no surprise to anybody given the environment that we're in. But let me cover the revenue. It's all constant currency. So what I'm going to talk about is constant currency. So the first year of the LRP will be 5.5%. We're at the -- we're guiding to the low end of our LRP which is 6%. So you are correct. There is a modest up-tick in revenue as you go from this year 2023 and to 2024 and 2025. And why is that? One of the main reasons for that is the improving macro environment that we expect to see beginning as we go through 2023 and continuing into 2024 and 2025. The second factor that will help that is the international expansion of some of our high-growth portfolio not just UroLift but also the international expansion of PICCs the international expansion of the intraosseous portfolio the international expansion of the hemostatic products that will bring accelerated growth in the latter half of the LRP. And we feel pretty confident in that. It's not a managed step-up. We're going from 5.5% to a 6% CAGR over the horizon of the LRP. And I think the other comment that I will make, that nobody has picked up on so far in their questioning is, durable core was 4% to 5%. While we've been micro-focused on one element of Teleflex the durable core has been improving all this time. And now the durable core for the LRP is now 5% at the upper end of the original guide of 4% to 5%, through excellent execution by the businesses globally. And the margins on a high-portion of that durable core are fairly substantive and helpful to Teleflex. And it's a $14 billion global TAM, for the high-growth and we're only 5% penetrated. So the opportunities for us to continue to grow into that are significant. But I'll let Tom address the margin question that you had Larry. And thanks for the questions.
Thomas Powell:
Sure, Larry. So the driver of the op margin expansion is really going to come from -- largely from the gross margin. And as you break that down, we're expecting continued margin accretion due to mix and price. Additionally, we have the MSA with Medline which ends at the end of 2023 and that adds close to a full point of margin as a result of that. And then, the third area is that, typically, we have enough productivity in our operations to more than offset inflation. That wasn't the case in 2022. That's not the case in 2023. We do expect to see that -- some improvement as we go into 2024 and 2025 on inflation. And as a result operations productivity once again becomes accretive to gross margin versus dilutive in 2022 and 2023. So those are kind of the key drivers of the gross margin. We also expect to see some leverage in the operating margin as a result of increasing revenues allowing us to leverage that cost structure. So if I think about the key components that would be the four points I'd reference.
Operator:
The next question comes from Michael Matson with Needham & Company. Michael, please go ahead.
Michael Matson:
Yeah, thanks. So I want to ask one on pricing. I think you said you had over 50 basis points and I think that was for the full year 2022. What have you kind of assumed in the guidance for 2023? Is it kind of remaining at that level? Could it even be higher maybe?
Liam Kelly:
So, we began the year in 2022, expecting 50 basis points of positive pricing and we exceeded that goal in 2022, Mike. So we came in comfortably above the 50 basis points. We would expect again to be above 50 basis points and to deliver a minimum of 50 basis points of pricing this year. And we have a pathway to that. We have some carryover from the prior year and we have some additional pricing opportunities that -- some of which we've already executed.
Michael Matson:
Okay. Got it. Thanks. And then, I think, Tom did call out some restructuring in his comments on the margin. So is that existing programs, or are you planning anything new there?
Thomas Powell:
That is existing programs. We have a number of footprint programs that are still finalizing and will be largely done by 2025. And then we introduced a new program in the fourth quarter of 2022 that will be complete by 2024. So everything I spoke about are known and existing programs that frankly we're managing to expectations.
Operator:
The next question comes from Matthew O'Brien with Piper Sandler. Matthew, please go ahead.
Matthew O'Brien:
Good morning. Thanks for taking the question. So, Liam, as I think about UroLift and this new 8% to 9% CAGR through the LRP, I think that's about $90 million to $100 million of incremental revenue through that time frame by 2025. So if I remember correctly, Japan and China were supposed to be pretty sizable contributors, I think, in the out years, maybe half of that $90 million to $100 million, maybe a little bit more than. So it would imply some fairly modest improvement here domestically. First of all, am I right about that? And then, secondly, how conservative is that? Does it make sense to be doing these DTC, or making this DTC spend, if you don't think the domestic business can really accelerate over the next several years?
Liam Kelly:
So, Matt, your overall math is fairly good, with regard to the growth in UroLift over the three-year horizon. I think that we still are reliant on the US to drive the bulk of the growth, just because the overseas markets aren't big enough. Clearly, overseas and international, we're encouraged by what we're doing. And by the time we get to the end of 2025, it will be a bigger portion of the revenue. And of course, on a smaller base, the percentage growth is going to be much better. We've done a really good job in Japan. We're going to do a really good job in China, Taiwan, India, France, Spain, Italy, Germany, Brazil and so on and so forth, but they're just not big enough to carry the growth to get us to that CAGR of 8% to 11%. I think that the DTC does make sense, to answer the other part of your question. If you go back to 2022, based on our expectations, the number of impressions were up by 27%. The number of responses were up double -- very strong double digits. So we feel that that is an encouraging factor. And every time I talk to urologists. And the same was true last week, when I was out on the road, patients are coming into them asking them for UroLift based on the ad campaigns that they see. So I think we will continue with the DTC campaign. And we believe that 8% to 11% is very achievable for us as a company.
Matthew O'Brien:
Okay. Appreciate that, Liam. And then, as far as the high-growth portfolio goes as well, coming down a little bit from -- I think, it was 14% to 15% before and now its 12% to 13%, still implies the rest of the portfolio outside of UL is strong. Can you talk about some of those components, what you're seeing from MANTA, EZ-IO, PICCs, et cetera, that are giving you the confidence to reiterate the strength in that segment of the business over the next several years? Thank you.
Liam Kelly:
Yes. So the high growth is doing really well. In the fourth quarter, it grew approximately 14%. The full year it grew approximately 14%, ex the contributions of UroLift. So, obviously, there are elements within the high growth that are above the average that we expect and there are elements of the high growth that will be slightly below it. Obviously, now the Titan, which comes from Standard Bariatrics, will be the fastest-growing. Then you have MANTA which will grow above the average. So we feel really good about the high-growth portfolio. We feel really good about being able to deliver the high growth of 12% to 13% over the LRP and we feel really good about being able to deliver 8% to 11% from the high growth in 2023. And the performance of all other aspects of the high growth, except for one, have been right in line, if not, ahead of our expectations for the entirety of 2022. And there's nothing better than momentum, as you know Matt as you head into 2023, 2024 and 2025 as you continue to build that out. And I know we talk a lot about international expansion with UroLift, but it is also the same for the rest of the high growth. There is international expansion as well as domestic sales growth as we tap into that market. And the encouraging thing is as I said earlier all of this high growth is growing into a massive market TAM where we're very underpenetrated, but significant opportunities for growth.
Operator:
Our next question comes from Anthony Petrone with Mizuho. Please go ahead, Anthony.
Anthony Petrone:
Thanks. Hope everyone is doing well. Maybe just in the LRP Standard Bariatrics just to kind of clean that up a bit in terms of the top-line contribution, it rolls into organic I would assume sometime later this year or early next year. So maybe the contribution from Standard Bariatrics within the LRP and can that actually be margin accretive by the end of the LRP? And I'll have a couple of follow-ups.
Liam Kelly:
Yes. And well done Anthony. Thanks for asking. So I'll answer the last part of your question first. Yes it will be margin-accretive by the end of the LRP. We expect it to become margin-accretive as we exit 2024. What you should expect from Standard Bariatrics is that it will deliver between $30 million and $35 million this year as we stated in our prepared remarks. And then as we said previously it should add approximately 50 basis points of growth to Teleflex year-over-year thereafter from an organic perspective. So that's what you should expect from Standard Bariatrics. Rough math should be around $60 million by the end of 2025.
Anthony Petrone:
And then a quick follow-up two I'll throw in there and I'll get back in queue. One just on UroLift when we think about it through 2025. Obviously, we saw some shifts in patient behavior. At what point do you think things sort of normalize here? Is there a path to normalization let's say at the end of this year early next year. I'm talking about US patient behavior. And then maybe just your updated views on the M&A landscape sort of what level of discussions is Teleflex having and just maybe your high-level views on M&A? Thanks.
Liam Kelly:
Yes. Sure, Anthony. So I expect the overall environment for urology patients and staffing to continue to improve as we go through 2023. When it's going to be 100% normal Anthony, it's difficult for me to actually pinpoint that right now in all fairness. But I do anticipate to continue to improve. And why do I say that? The staffing levels in hospitals began to improve in Q4. I expect that to continue into Q1 this year. And once staffing levels start to improve in hospitals it will ultimately then begin to improve in ASCs and ultimately in offices thereafter. And I think the patient flow as I said earlier there's still 12 million men suffering from BPH. If you walk into a urologist office and there's 100 men in the urology waiting room, 40 of them are there because they got BPH roughly. So it's still the number one reason why a man goes to the urologist. So the size of the market is a significant driver to my belief that it will return to normal as we go through the LRP at some stage. With regard to M&A, clearly, we have the most important thing that you need. We have a very strong balance sheet. For M&A, we're about 1.75 times levered at the end of the fourth quarter. We are active out there looking at opportunities. We have a lot of lines in the water. We're fishing hard Anthony. Very difficult for me to say and we're going to get a fish on the hook and into the boat. But there are targets out there that we are interested in. There are targets out there that we are actively pursuing. And we do believe that we are an attractive acquirer and there are assets that we feel would fit very well in the Teleflex family.
Operator:
Our next question comes from Craig Bijou with Bank of America Merrill Lynch. Craig, please go ahead.
Craig Bijou:
Good morning, guys. Thanks for taking questions. One let me just start with UroLift. And I did want to ask I know Japan was better than expected. Was Japan in the quarter -- was the 89 versus the 86 that was implied by your guidance was that Japan, or I guess if you could just kind comment on what drove the few million beat. Was that US or on the international side?
Liam Kelly :
So we saw improvement in both sides of the Atlantic. I keep getting back to the point that the international markets at this stage are not substantive enough to carry the can for the overall UroLift growth. And we would not have been able to beat by $3.3 million Craig the US delivering a good proportion of that. I am encouraged though as I said earlier on what we're doing in regards to the expansion overseas. Japan has gone exceptionally well. We did our first cases in China. We're starting to roll out in India and other geographies. I won't go through them all again, but we are encouraged by what we see with regards to that rollout.
Craig Bijou :
Got it. Thanks, Liam. And then on your comments on the durable core and appreciate that -- how that's kind of moved up in terms of the LRP growth. Maybe, I mean what are some of the products the categories that are really driving that and that you see driving that LRP growth for the next several years?
Liam Kelly:
Yes. I think as I look at where we see an improvement in an improving environment, first of all, what you have to understand is in 2022 we had a lot of supply chain issues. We had shortages of Tyvek shortages of simple components and so on and so forth. So that's going to drive some of the early improvements that you're going to see. So you should see an improvement in our Vascular business. As you go through 2023 and beyond Vascular grew in the entire year about 1% constant currency. The normal growth for that business is in the mid single digits. I also believe that Interventional Access, we've got a lovely suite of new products coming through in Interventional Access and that's the late blood of that business. And Interventional Access, we would anticipate will continue to accelerate. One of our -- I guess, more than the durable core one of our underappreciated assets is our OEM business. We bought this company called HPC a couple of years ago. It does thin-walled catheters. That on top of the rest of the OEM business has continued to grow in the high single low double digits from a business that historically used to grow around 3% or 4%. So I anticipate that OEM will continue to flourish will continue to accelerate its growth over the LRP and be a real contributor. And never forget it's accretive to our operating margin and will drive that. And obviously, APAC is a key growth franchise for us. We have a lot of products that we are launching into the APAC region that we believe will be very successful there. So those are some of the key areas that I believe will continue to grow. And as I said earlier as we go through the LRP, we would anticipate that Interventional Urology would also improve as we go through the LRP.
Operator:
Our next question comes from George Sellers with Stephens. George, please go ahead.
George Sellers:
Hi. Thanks for squeezing me in here. I'll just ask one quick one. Could you give us a little color on what you're seeing in terms of private market valuations and how those have trended here recently? And maybe how confident are you that you could potentially deploy some capital here in the near term? Thank you.
Liam Kelly :
So George, as you know it takes two to get married. So we're a willing groom or bride whichever way you want to put us. And it's a question of finding the other party. I will tell you the valuations from the heady days of 2021 have moderated somewhat. And high-quality assets are still not – inexpensive, but that's why they're high-quality assets and those are the assets that we're going after. But you can -- we will remain disciplined George and investors can expect us to remain disciplined. We will look for assets that are accretive to our top line growth. We look for assets that are accretive to our gross margins. We look for assets that will become accretive to our op margins and earnings pretty quickly after we acquire them. We will -- we're very disciplined on our return on capital and getting above our internal cost of capital by at least year five. We've always been able to do that in year four. But the hurdles will remain the same for Teleflex in finding good assets, bringing them into the family and integrating them into Teleflex and obviously, assets that are unique in the marketplace in segments that are growing faster than that core segments within Teleflex.
Operator:
Our next question comes from Matt Mishan with KeyBanc. Please go ahead. Your line is open.
Matt Mishan:
Great. Thanks for taking the questions. Just a quick clarification for Liam, and then I'll have a follow-up for Tom. On the low end of the 6% to 7% from '22 to '25, does that include the inorganic contribution of Standard Bariatrics in 2023?
Liam Kelly:
Yes. As we said in our prepared remarks, and as I said a couple of times already, the changes that we're making is we're revising the high-growth bucket and the UroLift component of that high-growth bucket, and we're adding Standard Bariatrics. So that's it. That's correct.
Matt Mishan:
Okay. And then just for Tom, on the tax rate, 10.25% to 10.75% for 2023 is pretty low, especially compared to historical standards. What's driving that for 2023? And how should people think about the sustainability of that tax rate moving forward into the next couple of years?
Thomas Powell:
Well, I would say that, as you look at 2023, there's two drivers of the tax rate. One is the change in the tax law related to the capitalization of R&D expenses. We'll start to provide some ability to amortize in 2023. So we have a less of an expense impact as a result of that. And the other driver would be the IT consolidation projects or consolidation projects that we've undertaken will begin to show a higher benefit in 2023. And those benefits will continue throughout the LRP time frame. So you should think about the rate as being sustainable. I would say that there is one caveat in that the EU is currently assessing a minimum tax, if that were to become legislation, that could have an adverse impact on our tax rate.
Liam Kelly:
And Matt, I just want...
Thomas Powell:
And I should say that's contemplated for 2024, no 2023 impact.
Liam Kelly:
Sorry, Tom. Yes. And Matt, I just want to circle back on the Standard Bariatrics question. The difference between pro forma and Standard Bariatrics as is isn't that significant, given that the product is only recently on the market and the growth has been driven by Teleflex, following the training of our sales force. So we've doubled the sales force. So, it isn't that significant, the difference one way or the other, Matt, is what I would tell you.
Operator:
Those are all the questions we have time for today. So I'll now turn the call back to Lawrence for any concluding remarks.
Lawrence Keusch:
Thank you, Emily, and thank you to everyone that joined us on the call today. This concludes the Teleflex Incorporated Fourth Quarter 2022 Earnings Conference Call.
Operator:
Thank you, everyone, for joining us today. Our conference call for today is now concluded. Thank you for your participation. You may now disconnect your lines.
Operator:
Good morning, ladies and gentlemen and welcome to the Teleflex Third Quarter 2022 Earnings Conference Call. [Operator Instructions] Please note that this conference call is being recorded and will be available on the company's website for replay shortly. And now, I will turn the call over to Mr. Lawrence Keusch, Vice President of Investor Relations and Strategy Development.
Lawrence Keusch:
Good morning, everyone and welcome to the Teleflex Incorporated Third Quarter 2022 Earnings Conference Call. The press release and slides to accompany this call are available on our website at teleflex.com. As a reminder, this call will be available on our website and a replay will also be available. Please refer to our press release from this morning for details on how to access the replay. Participating on today's call are Liam Kelly, Chairman, President and Chief Executive Officer; and Thomas Powell, Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks and then we will open the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include but are not limited to, factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K which can be accessed on our website. During this conference call, you will hear management make statements regarding intra-quarter business performance. Management is providing this commentary to provide the investment community with additional insights concerning trends and these disclosures may not occur in subsequent quarters. With that said, I will now turn the call over to Liam for his remarks.
Liam Kelly:
Thank you, Larry and good morning, everyone. For the third quarter, Teleflex revenues were $686.8 million, a year-over-year decline of 1.9% on a reported basis and an increase of 2.4% on a constant currency basis. Compared to the prior year period, revenue under the manufacturing and supply transition agreement associated with our prior divestiture of the Respiratory assets negatively impacted growth by 1.3% in the quarter, implying underlying constant currency growth of 3.7%. Adjusted earnings per share declined by 6.8% year-over-year to $3.27. In reviewing the quarter, the majority of our business units executed well. When excluding UroLift and adjusting for the Respiratory divestiture, the remaining 88% of the business grew at an underlying rate of 4.3% in the third quarter. This solid performance continues to reflect the benefit of Teleflex's diversified portfolio that has been purposely built to target the care of critically ill patients. We saw improvement in revenues as the third quarter progressed with September strengthening over July and August. Our OEM business unit drove double-digit constant currency year-over-year revenue growth. While the Interventional business unit grew approximately 9%. Our Surgical business turned in another solid performance with mid-single-digit constant currency growth year-over-year. From a geographic perspective, we saw strong results in Asia which continues to be an important growth driver for Teleflex. Conversely, Interventional Urology continues to be impacted by patient business to urologists that remain down year-over-year and staffing shortages, with third quarter revenues modestly missing internal objectives. In the quarter, our high-growth revenue which includes UroLift, MANTA, hemostatic products, EZ-IO, on controls and PIC maintained momentum across the majority of growth drivers. For the 9 months, UroLift has declined 5.8% year-over-year. While the remainder of products in the high-growth portfolio continues to show healthy gains with 14% growth. Moving over to durable core revenues which accounted for more than 60% of revenues in 2021. In the first 9 months of 2022, the durable core has generated 4.6% growth compared to the prior year period. Turning to inflation; there are elements of stabilization during the quarter with some areas of improvement. In particular, sea freight costs declined in line with our internal expectations. We continue to see elements of elevated supply-chain disruption during the third quarter. Availability of select raw materials and components are not yet back to normal. This dynamic resulted in some greater-than-anticipated backorder levels during the third quarter, especially in our Vascular and Interventional businesses. Looking forward, we expect a portion of those unanticipated back orders to flush through by the end of 2022. Now, let's turn to a deeper dive into our third quarter revenue results. I will begin with a review of our reportable segment revenues for the third quarter. All growth rates that I referred to are on a constant currency basis unless otherwise noted. Americas revenues were $405.1 million which represents a 2.7% decline year-over-year against a tough comp in the year ago period. Lower revenue from the manufacturing supply-and-transition agreement associated with our prior divestiture of the Respiratory assets negatively impacted Americas growth by 2.1%, implying a flattish underlying performance for the quarter. Interventional recorded high single-digit growth, offset by declines in Vascular and Interventional Urology. In addition, we did experience some supply-chain disruption during the third quarter. EMEA revenues of $128.4 million increased 3.4% year-over-year. We continue to see procedure volumes improve year-over-year. Now turning to Asia; revenues were $82 million, increasing a robust 20.5% year-over-year. We saw strength across the region with all geographies posting growth during the third quarter. China had a very strong performance with growth exceeding 19%. Let's now move to a discussion of our third quarter revenues by global product category. Consistent with my prior comments regarding our reportable segments, commentary on global product category growth in the third quarter will also be on a constant currency basis and ranked by size of our business units. Starting with Vascular Access; revenue decreased 0.8% to $167.1 million. The performance in the quarter in part reflects a tough comp due to the year-over-year reduction in COVID patients in the intensive care unit in the United States. As previously noted, there was some elevation in backorder during the quarter due to raw material shortages. Of note, the vascular business has the greatest exposure to tieback packaging for our kits and trays. We anticipate that tieback shortages will abate in 2023 as additional supply for the industry comes online. We remain confident that our category leadership in central venous catheters and midlines, along with our novel coated PICC portfolio continued to position us for dependable growth. Moving to Interventional; revenue was $108.7 million, up 8.9% year-over-year. We saw strong performances across our diversified portfolio during the third quarter, with balloon pumps on control, MANTA and complex catheters all contributing to growth. We continue to see some elements of supply-chain disruption during the quarter. Turning to anesthesia; revenue was $97.6 million, up 5.8% year-over-year. The business had a challenging comparison with 26.6% growth last year. Of our larger franchises, regional anesthesia, hemostatic products, endotracheal tubes, all contributed double-digit growth in the third quarter. In our Surgical business; revenue was $93.1 million, representing another solid performance with 6.2% growth year-over-year. Among our largest product categories, skin stapling led the growth for the quarter, while metal and polymer ligation clip growth accelerated sequentially, following COVID-related lockdowns in China during the second quarter. Of note, there are no revenues in the third quarter surgical results from the Standard Bariatrics acquisition. For Interventional Urology, revenue was $79 million, representing a flattish performance sequentially and a decrease of 4.6% year-over-year and slightly below our internal expectations. The overall environment for elective BPH procedures has not yet returned to normal. Third-party data indicates that overall patient visits to urologists were down high single digits year-over-year in the quarter which has impacted the funnel for BPH procedures. In addition, staffing shortages remain a constraint. In a Teleflex survey of U.S.-based urologists, conducted in August of this year, 52% of the 125 respondents reported having experienced staffing issues. The survey also indicated that office-based urologists are experiencing significantly more patient cancellations per week than hospital-based urologists. OEM revenues increased 14.4% year-over-year to $71.3 million despite a tough comparison to last year. Our order book remains well positioned as customers recognize our broad competencies with competitive capabilities, including fast growth markets for thin wall interventional microcatheters to assess small vessels and fine wire for sensing and ablation technology. Third quarter, other revenue declined 9.9% to $69.9 million year-over-year. The majority of the decline reflects lower manufacturing and supply transition agreement revenues year-over-year. We continue to expect all MSA revenues to cease at the end of 2023. That completes my comments on the third quarter revenue performance. Turning to some commercial and clinical updates. On September 28, we closed on our acquisition of Standard Bariatrics for an upfront cash payment of $170 million with additional consideration of up to $130 million payable upon the achievement of certain commercial milestones. Standard Bariatrics has commercialized the Titan SGS stapler which is an innovative powered stapling technology specifically designed for sleeve gastrerectomy. We estimate that there were 120,000 sleeve gastrectomy procedures in 2020. We are very excited about the acquisition of Standard Bariatrics for a number of reasons. First, the Titan stapler addresses unmet needs in sleeve gastrectomy by offering surgeons the longest continuous push and staple line of 23 centimeters. It is designed to help surgeons achieve more consistent and symmetrical sleep pouch anatomy, setting their patients up for optimized outcomes. While every patient's anatomy is different, the Titan's long staple line enables surgeons to plan and place staples in one firing, minimizing variations sometimes associated with the use of multiple overlapping short cartridge staple firing. Additionally, the design may result in a more secure staple line and fewer chances of leaks, as evidenced with higher burst pressures. Second, we believe that we can compete effectively stapling share in the sleep gastrectomy market. Following a third quarter 2020 U.S. launch, we expect Titan stapler revenues to be approximately $15 million in 2022. With the Titan stapler now part of the Teleflex surgical portfolio, we expect continued momentum going forward. The Titan Stapler products [indiscernible] into our existing bariatric surgery call point in our Surgical business and complements our ligation clip portfolio, MiniLap percutaneous surgical system and Weck EFx special closure portfolio. In addition, the inclusion of the Standard Bariatrics sales team doubled our commercial team addressing the sleeve gastrectomy market. We have the capability to flex higher with existing Teleflex reps as demand grows which would more than triple the stand-alone sales force of Standard Bariatrics. Finally, we see a pathway through value analysis committees with carve-out due to the differentiation of the stapler which gives us confidence in our ability to expand our user base over the coming years. Third, the acquisition of the Titan Stapler reflects Teleflex's strategy to invest in innovative products and technologies that can meaningfully enhance clinical efficacy, patient safety and comfort, reduce complications and lower the overall cost of care. From a financial perspective, the acquisition is immediately accretive to Teleflex's long-term revenue growth profile and will enhance our gross and operating margin over time. Moving over to Interventional; we relaunched the Langston Dual Lumen Catheter and expect sales to ramp up in the fourth quarter and into 2023. In addition, at the mid-September TCT conference, we highlighted the Karolinska 1000 consecutive MANTA device study. This study which was not sponsored by Teleflex, represents the largest real-world evaluation of the MANTA device in patients undergoing TAVI. The study demonstrated low complication rates and a short learning curve. Specifically, MANTA device-related major vascular complications occurred in 4.2% of patients which was consistent with the SAFE MANTA IDE study and the MARVEL prospective registry. With respect to our market development objectives for UroLift, we were again pleased with our progress during the quarter. Training of new physicians continued in the third quarter and we are on track to reach our target for the year. With access to surgeons improving, we recently hosted a live BPH Summit training session in the United States as we continue to tap into surgeons not yet trained on UroLift. We are also excited to host an upcoming BPH Summit in Japan during the fourth quarter. We continue to receive excellent feedback from surgeons regarding UroLift 2, while UroLift advanced tissue control for use in obstructive median lobes saw increased momentum in the third quarter. New data published in the peer-reviewed Journal of Endourology revealed that in a controlled clinical trial of the UroLift system for obstructive median lobes, men experienced better symptom improvement within the first three months of treatment compared to those treated with placebo and TURP in other controlled studies. Encouragingly, those patients did not endure high-grade serious adverse events. The data further reveals that symptoms and EuroFlow outcomes were largely consistent for obstructive median lobes patients treated in both, controlled and real-world settings. We believe that the launch of the UroLift two in advanced tissue control will enable us to further engage with surgeons and drive utilization deeper into our label's indications. Based on our progress at the end of the third quarter, we remain on track to convert the vast majority of our U.S. customers to UroLift two by the end of 2022. Now, turning to an update on our international expansion strategy for UroLift. We are in the early stages of a multiyear, multigeography international market expansion which is expected to be a meaningful driver of growth in the coming years. The launch of UroLift in Japan which began on April 1, continues to gain momentum and is tracking to our plan. Cases are continuing to ramp up and we are very encouraged with the results thus far. Looking forward, we are excited to implement our virtual reality capabilities to enhance our physician training and sales force interactivity. Given our results to date, we expect to be well positioned to increase traction in 2023 as we expand our reach into key regions within the country. Shifting to other international geographies. We remain on track with our expected UroLift commercial milestones. In China, we will commence our initial launch activities in the fourth quarter with a focus on key cities and engagement with the urological society to build acceptance. In addition, we still expect updated reimbursement in France and launches in select regions in Italy and Spain during the fourth quarter. Finally, investors familiar with Teleflex will recall that, in July of 2020, we informed the investment community that the Department of Justice had opened an investigation under the Civil False Claims Act with respect to one of our subsidiaries, NeoTract Inc. I am glad to share that, in August of 2022, the U.S. Department of Justice advised us that it had closed the investigation. We are pleased to have this investigation behind us and look forward to continuing our focus on the patients we serve across the world every day. That completes my prepared remarks. Now, I would like to turn the call over to Tom for a more detailed review of our third quarter financial results. Tom?
Thomas Powell:
Thanks, Liam and good morning. Given the previous discussion of the company's revenue performance, I'll begin with margins. For the quarter, adjusted gross margin totaled 58.7%, an 80-basis point decrease versus the prior year period. The year-over-year decrease was driven by the expected incremental inflation, partially offset by favorable pricing. As expected, we have seen an improvement in sea freight, although raw material and component availability have yet to normalize. Of note, our pricing strategy continued to maintain its traction through the third quarter. Adjusted operating margin was 26.9% in the third quarter. The 160-basis point year-over-year decline was the result of the lower gross margin, deleverage across our expense base from lower revenue year-over-year, inflation in our expense base such as wages and planned investment in the business for our growth drivers, partially offset by disciplined expense management of nonrevenue-generating expense. Net interest expense totaled $13.2 million in the third quarter, an increase from $11.8 million in the prior year period. The $1.4 million year-over-year increase in net interest expense reflects higher interest rates versus the prior year, partially offset by a reduction in average debt outstanding. Our adjusted tax rate for the third quarter of 2022 was 9.8% compared to 11.3% in the prior year period. The year-over-year decrease in our adjusted tax rate is primarily due to further enhancements in tax efficiencies of our global structure, partially offset by tax expense arising from the new provision of the U.S. tax law requiring the capitalization of certain R&D expenses. At the bottom line, third quarter adjusted earnings per share was $3.27, a decrease of 6.8% versus prior year. Turning to select balance sheet and cash flow highlights. Cash flow from operations for the 9 months was $244.4 million compared to $450.5 million in the prior year period. The decrease was primarily due to lower operating results, higher tax payments, higher payroll and benefit-related payments and unfavorable changes in working capital, driven by an increase in inventory purchases to maintain high customer service levels during a period of elevated global supply-chain volatility. Moving to the balance sheet. Our financial position remains healthy. At the end of the third quarter, our cash balance was $397.3 million as compared to $445.1 million as of year-end 2021. Reduction in cash on hand is due to $144 million of payments on our senior credit facility. At the end of the third quarter, our floating rate debt accounted for 42% of the total debt outstanding and net leverage at quarter end was approximately 1.7x. On a pro forma basis, including Standard Bariatrics, net leverage is 1.9x which remains well below our 4.5x covenant. Now turning to our 2022 guidance update. We are maintaining our 2022 constant currency revenue growth guidance of 3.25% to 4.25%. When excluding the impact of the Respiratory divestiture and normalizing for the one life shipping day, the underlying growth projection for the business remains over 5% year-over-year when considering the midpoint of our 2022 constant currency revenue growth guidance. Turning now to foreign exchange. The dollar has further strengthened across a broad number of currencies as compared to our prior guidance. We now expect that the impact of foreign exchange will be a headwind to revenue of approximately 4% in 2022 versus 3.7% expected previously. This equates to an approximately $110 million reported revenue headwind year-over-year as compared to approximately $100 million in the prior guidance. Considering the revised outlook for foreign exchange, we are reducing our reported revenue growth to negative 0.75% to positive 0.25% in 2022, implying a dollar range of $2.789 billion to $2.817 billion. Moving to additional comments regarding the revenue outlook for 2022. We expect incremental revenue from Standard Bariatrics to be in the range of $4 million to $5 million in the fourth quarter. For UroLift, we are now assuming that 2022 revenue will be roughly $320 million versus the prior guidance of $335 million. Our prior guidance had assumed an improving environment for UroLift during the second half of 2022 with a sequential revenue increase in the third quarter and a further sequential increase in the fourth quarter. Given the persistence of procedure environment headwinds, our revised guidance assumes no underlying improvement in the current environment for the remainder of the year. Turning to the middle of the income statement. We expect gross margin for 2022 to be 58.75% to 59.25% versus 59% to 59.5% previously. The slightly lower outlook for gross margin reflects the impact from unfavorable mix. Our gross margin guidance range continues to reflect the impact of incremental inflationary pressure which represents a year-over-year headwind of approximately 100 basis points. Importantly, we remain confident in our ability to achieve at least 50 basis points in price for the year which helps partially offset the inflationary pressures that we are experiencing in our cost of goods line this year. As a matter of course, we will continue to assess our global pricing and we'll continue to make adjustments as opportunities arise. Relative to operating margin, we now expect operating margin to fall within a range of 26.5% to 27% versus 26.75% to 27.25% previously. Our guidance reflects the impact of the gross margin and incremental operating expense from Standard Bariatrics which was not contemplated in prior guidance, partially offset by the better-than-expected operating expense in the third quarter. Turning to items below the line. We continue to expect an adjusted tax rate in the 11% to 11.5% range for 2022. We now expect net interest expense to approximately $54 million for 2022 as compared to $51 million previously. The majority of the increase in our net interest expense outlook reflects debt associated with the acquisition of Standard Bariatrics. Moving to earnings; we are reducing our adjusted earnings per share guidance for 2022 to $12.80 to $13.20 compared to $13 to $13.40 previously. The reduction in guidance reflects the earnings performance in Q3, offset by dilution from the Standard Bariatrics acquisition, the revised impact from foreign exchange and the margin impact from mix. Under the revised guidance, adjusted earnings per share of $12.80 to $13.20 amounts to a 4% year-over-year decline at the low end and a 1% decline at the high end. Normalizing for incremental inflation, foreign exchange, the Respiratory divestiture and dilution from the Standard Bariatrics acquisition implies underlying adjusted earnings per share growth at the midpoint of guidance in the high single-digit range year-over-year in 2022 and reflects the benefits of our diverse growth drivers and ability to grow earnings in a period of significant macro challenges. That concludes my prepared remarks. I would now like to turn it back to Liam for closing commentary.
Liam Kelly:
Thanks, Tom. In closing, I will highlight our three key takeaways from the third quarter and our 2022 outlook. First, our third quarter results reflect the diversification of the Teleflex portfolio through the combination of our growth drivers and stability of durable core revenues. Importantly, we will continue to focus on investment in our future growth drivers while managing overall costs for the business. Second, in the quarter, we augmented our growth drivers with the acquisition of the Standard Bariatrics Titan SGS powered stapler. We expect revenue growth and margin accretion over time as we effectively integrate Standard Bariatrics into the Teleflex Surgical business and expand the reach of this innovative stapling technology. Accordingly, we expect the Standard Bariatrics acquisition to enhance our long-term constant currency growth. Third, we continue to execute against our long-term growth strategy. We will continue to incrementally invest in our high-growth portfolio and drive dependable expansion in our durable core portfolio. We have levers in place to drive further expansion in our margins. And our balance sheet is in a solid position with pro forma leverage of 1.9x, providing ample financial flexibility for our capital allocation priorities, including M&A. That concludes my prepared remarks. Now, I would like to turn the call back to the operator for Q&A.
Operator:
Thank you. [Operator Instructions] Our first question comes from Cecilia Furlong with Morgan Stanley. Cecilia, your line is open.
Cecilia Furlong:
Good morning and thank you for taking the questions. Liam, I wanted to start on your commentary on UroLift and really just the site of care that you talked about in terms of where you're seeing patient flow offices versus inpatient. Can you just talk about how that's trended versus pre-COVID times? And then also just the role of DTC, you talked about surgeon training. How you're thinking about DTC going forward?
Liam Kelly:
Hi, Cecilia, thank you for the question. With regard to pre-COVID patient flow and post-COVID patient flow. So we know that in Q2, patient flow was down approximately 12%. It was down high single digits in Q3 and we know that in 2021, patient visits were also below pre-COVID levels. So you add those together and we're seeing a significant drop in patient flow pre-COVID. The other impact is obviously staffing shortages. Now in the rest of our business and also within the UroLift portfolio included in that, we did see a modest improvement in staffing levels in the hospital side of service. So that was somewhat encouraging during the quarter. And if that continues -- that will continue to be encouraging. With regard to our DTC, we believe that the DTC continues to add value. We're ahead of our targets with regard to patients that we're transferring to urologists. TV actually dominates the way men first learn about UroLift. So it is definitely a medium we want to continue. And our brand awareness for UroLift continues to rise. So it is now at 19%, well ahead of TURP in that regard and TURP is seen as the gold standard when it comes to brand awareness and that's why I'm comparing it to TURP. So we're very encouraged by the results that we have from DTC. And it is our expectation to continue that. We do believe that the market will eventually recover. We do believe the patient flow will improve. We do believe that staffing levels will improve. And when that does happen, we're well positioned to take advantage of it.
Cecilia Furlong:
Great, thank you. And if I could follow up, just your comments on Japan as well, the initial launch there. Can you talk through either your contribution, what you're seeing to date, outlook for 4Q? And then as you think beyond '22, just to your confidence, especially just given the current macro environment with the 15% growth that you laid out at the Analyst Day earlier this year? And thank you for taking the questions.
Liam Kelly:
No, absolutely. So we're encouraged by what's happening in Japan. As you know, I was there in Q2 and met with a number of urologists. The adoption continues to be very solid within the geography. And obviously, this quarter, we will do our first UroLift cases in China which is, again, a good opportunity for us. Obviously, with -- in regards to the LRP, we do need to see the market recover. And I presume you're asking specifically to UroLift, I think that the LRP was a CAGR of 15% for UroLift over the 3-year horizon. And our LRP doesn't actually begin for another 2-and-a-bit months. It was using 2020 is to jump off and then beginning in 2022 as a jump off and then 2023 as the first year. Now as I said already, we do need to see the end markets recovering. We do need to see that patient flows begin to come back. And we do need to see staffing levels improve. And we are prepared when that does happen. Our sales force is fully staffed. The DTC has continued. The clinical data is compelling. The market is still massive. There's still 12 million men in the United States that suffer with BPH. And our patient survey that we did, does tell us that we are getting a heightened level of cancellations from patients for BPH procedures. And as the environment continues to improve, we would expect that to improve also.
Operator:
Thank you. And our next question comes from Jayson Bedford of Raymond James. Your line is open.
Jayson Bedford:
Good morning. Maybe for Tom or the group. Just in this environment, revenue has slowed a little bit in the business. Wondering if this has impacted your thoughts on the pace of margin expansion, specifically thinking about your LRP goals.
Thomas Powell:
Well, I will say that as revenue slows, you do lose leverage in the P&L. And for us to continue to drive margin expansion, we want to see that top line moving. I think as Liam just touched on, the LRP doesn't start for another couple of months. And our expectation is to continue to grow the top line. We'll have to look and see how inflation impacts us but that certainly has been a drag as well. But if you think about the business, the key tenets of margin expansion remain with restructuring programs are still in place. We do have good growth in our high-growth portfolio which, as you know, has got higher than average margin. So as Liam mentioned, getting UroLift back and growing in North America at a solid pace will certainly help us assure that margin achievement over the longer-term horizon.
Liam Kelly:
And Jayson, I would just add, you are correct that the revenue has slowed. But if you normalize for the days in the Respiratory divestiture and you take the midpoint of our guidance for the remainder of the year, it will tell you that our underlying growth is actually in excess of 5%. And that's even with the decline in the current environment with the UroLift revenue. Obviously, an improvement in that will help us. And we have got really good pricing discipline, as you know. And we feel that we will do well in excess of that 50 basis points that we laid out. And we also have the restructuring programs which through the LRP will deliver another $28 million of benefit dropping through the gross margin line through to operating margins. So lots of moving pieces and we're in an inflationary environment and we will potentially lose some leverage this year. But with an improving environment, we'll see what will happen over the LRP timeframe.
Jayson Bedford:
Okay. And just as a quick follow-up. Liam, you mentioned an elevated backlog during the quarter. Is there a dollar amount that you could attribute to this dynamic?
Liam Kelly:
So I don't want to get into too many specifics of a dollar amount but it's in the -- obviously, clearly in the millions of dollars and it was really impacting the Vascular Access business and the Interventional Access business. Those were the two that were most impacted. We have third-party providers in both of those businesses, one being Tyvek and the other being a third-party extrusion company that's causing us some difficulties at this moment in time. We would expect that to normalize in the fourth quarter and it's part of the reason we're able to maintain our constant currency guidance, that and the addition of Standard Bariatrics.
Operator:
Thank you. We now have Shagun Singh from RBC. Please go ahead when you’re ready.
Shagun Singh:
Thank you so much. Can you hear me, okay?
Liam Kelly:
We can hear you, Shagun.
Shagun Singh:
Okay, great. So, I was just wondering, Liam, if you can share any specific data points that might suggest that patients will return once the environment stabilizes. I'm a little surprised given the pace of cancellations for UroLift. So what makes you confident? And then your Q4 UroLift guidance now implied $86 million versus $101 million implied in the prior guidance. What gives you the confidence that you can achieve the 15% CAGR in '23 and beyond? And then can you just remind us of your confidence in the 6% to 7% LRP if UroLift does slow in 2023 and beyond. I know you made the acquisition of Surgical Bariatrics [ph] that adds about 60 basis points. So that should help offset some of that headwind. But if you can just talk about the 6% to 7% and how you're thinking about M&A as you think about the portfolio overall? Thank you for taking the questions.
Liam Kelly:
Okay. Thanks, Shagun. There's a lot in that to unpack. So let me begin. As I said earlier, the LRP begins in 2-and-a-bit months, I think I feel confident in the 6% to 7% we outlined and the addition of Standard Bariatrics helps my confidence on the 6% to 7% CAGR over that period of time. I think that, again, reminding people that the 15% for UroLift is also a CAGR. And we probably have an easier comparable in the first year of that 3-year plan that should help us to improve that. Why do I feel confident that patients will return? Because there's a lot of them. There is 12 million patients out there that our target market is the 1.5 million men that have BPH, took the pill and no longer take it. And I'm also encouraged by what I see going on in the hospital environment where staffing levels are starting to improve. Some -- what we've learned from our patient study is some patients are having difficulty making appointments to actually get in to see the urologists. So if that staffing improvement in the hospital moves to the office and the ASC, that should also assist in getting that to come back. And you're correct in your math, it would imply for Q4 an $86 million number for UroLift. And what is considered in that is just the normal seasonality that one sees because of the deductible impact that happens every year going from Q3 to Q4. And obviously, the input from the international markets as we expand over there. So there isn't, in our $86 million, an implied continued recovery. If that happens, that will help but it's not implied in our guide as we've given it today.
Operator:
Thank you. Your next question comes from the line of Matt Taylor of Jefferies. You may proceed with your questions.
Matt Taylor:
Hi, good morning, guys. Can you hear me, okay?
Liam Kelly:
We can hear you, Matt. Good morning.
Matt Taylor:
Great. Hi, men. I’m okay. I have a couple of questions. I'll keep my questions to [indiscernible]. So, I wanted to ask you about -- you said you're going to be well in excess of the 50 basis points. So can you give us any sense for how much better you're tracking? And then also, can you keep this up next year? Is it something that you view as durable? Or is it more onetime?
Liam Kelly:
So I think that Teleflex has always been a company that can carve out pricing even in a nonpricing environment. When none of our peer companies were getting pricing over the last number of years, we were always able to carve out 10 or 20 basis points. I think that we will do in excess of 50 basis points this year. We're tracking ahead of that, Matt, for the first three quarters. And I do think that we will be able to repeat that again next year at least. We are living in an inflationary environment. We're being impacted by it. Our customers are getting impacted by it. We're trying to walk that very fine line where we're being partners with our customers but at the same time, recognizing that we are seeing inflation. Inflation for us is costing us 100 basis points in gross margin this year as a result of what's being passed on to us from our customers. And therefore, there must be a recognition that we must pass some of that on to our customers and in a thoughtful way and in a way that maintains that business relationship with the customer.
Matt Taylor:
Okay. Got you. And then I want to check some math. I went back on the disclosures about the high-growth portfolio ex UroLift. And I think it looks like you did like low double digits in Q1, excess of 20% in Q2. And then it looks like low double digits in Q3 versus -- is that correct? And then the 14% year-to-date, what do you expect for the high-growth portfolio going forward? And are the fluctuations quarter-by-quarter just comps? Or is there something else going on there?
Liam Kelly:
No, the quarter-by-quarter isn't comps. The quarter-by-quarter, honestly, Matt, is some backorder clearance as we've had a few issues with Tyvek in some of our businesses, it flushes through in one quarter and that's what really -- if you go back to the transcript of Q2, we outlined that we had cleared through some backorders. So it's not particularly comps. It's really the timing of some of these backorders clearing as we overcome some of the supply-chain constraints. And you're correct in your math that we do expect that it is running at just over 14% ex UroLift for the first three quarters. And obviously, we anticipate staying in that region for the remainder of the year. So our high growth ex UroLift is performing well in line with expectations. And once UroLift recovers, that entire high-growth bucket should improve. And obviously, for individuals working their models, Standard Bariatrics will be included in the high-growth portfolio moving forward.
Operator:
We now have the next question on the line from Mike Polark of Wolfe Research. Please go ahead when you’re ready.
Mike Polark:
Good morning. Thank you for taking my question. I have one on UroLift and then one on Standard Bariatrics. On UroLift, just 3Q to 4Q and I know this was asked differently but what is the lift embedded from the OUS efforts ramping into 4Q? Can you frame kind of the $7 million sequential step up? How much of that do you view as kind of the core U.S. business versus some of the OUS stuff starting to contribute more meaningfully?
Liam Kelly:
Yes. So on that one, normally, what you see in seasonality within the U.S. is a pickup in that, call it, 7% to 10% just based on the deductible phenomenon that goes with that. Obviously, OUS, in particular, Japan has been ramping steadily. And as we advised investors, it's 1/3 of the size of the U.S. and we expected it to ramp at 1/3 of the size of the U.S. And in the first year, the U.S. business has done $5 million and then $15 million and then $50 million and so on and so forth. So if you take 1/3 of that, that would be a good metric for Japan. And we continue -- and the contribution in all transparency in China is very modest within the fourth quarter. So I wouldn't advise building much in for that. We will do cases. It's difficult to get people in and out of the country but we are encouraged to ramp within -- in 2023 and China would be more of a 2023 ramp than a 2022 impact.
Mike Polark:
Helpful. And then on Standard Bariatrics, $15 million for the product this year in its first full year, you're guiding, I believe, $30 million to $35 million next year, a very healthy ramp. It's a sizable market and you've structured in a sizable earnout. So I'm curious, what's the dream of the sellers here? How much kind of upside is implied? And if they achieve their earn-out, what does that mean for the revenue run rate and over what time horizon, is that framed up?
Liam Kelly:
Yes, Mike, I think the way I'd frame that is that Teleflex pays out the full $130 million, no one will be happier than Liam Kelly because that will mean that the business will have done better than I would have anticipated. I think that when we look at this business, it's a unique technology. And I look at this and a lot of these technologies that gain share, they tend to be evolution rather than revolution. And this really fits into that category. It's right into the sleeve gastrectomy market that the surgeons conduct every day. It speeds up the procedure, you get less leaks, higher burst pressure when you complete it. And all in all, it's being adopted pretty rapidly out there. We have a number of the high-volume users that have already adopted the technology and a high-volume user for us will be someone that's doing 10 sleeves a month. And we're very encouraged by the way it's moving forward. But to your question, if we pay out the $130 million, Teleflex would be delighted.
Operator:
Thank you. We now have Craig Bijou of Bank of America Merrill Lynch. Please go ahead, your line is open.
Craig Bijou:
Good morning, guys. Thanks for taking my questions. Just a couple on UroLift. And I appreciate all the comments that you made, Liam but I wanted to ask specifically on -- so I believe you said doc visits were down 12% year-over-year in Q2. Now they're down high single digits in Q3. But sales for you guys were, let's call it, just flat sequentially. So I wanted to reconcile that dynamic. And I know you mentioned that staffing was getting better in the hospitals. But did staffing improve in the office setting from Q3 to Q2? Or did it get worse? And then, is there a timing factor from visit to procedure that may be kind of embedded in those numbers as we look at them sequentially from Q2 to Q3?
Liam Kelly:
Yes, I'll answer the last bit of it first, Craig. Yes, there's definitely a lag. So it takes somewhere in the region of 6 to 8 weeks for a patient to work through the funnel and have a procedure do. They've got to come in, see the urologist. They've got to do their IPSS score. They've got to do a cystoscope. And then they've got to get slated for a procedure. We did our survey of urologists in August. And we know that, in general, 53% of them are suffering with staffing shortages. But if you look at the urologists in the office side of service, their staffing shortages are more acute. 61% of that category of urologists said that they were suffering with staffing shortages. So I think that the -- I did see an improvement in the hospital side of service. From a staffing level, the office was as it was in Q2, no significant improvement. I will say, Craig, though, as the hospital side of service does improve, that frees up capacity for the office and ASC to improve -- approve. So I would anticipate there will be a lag in the improvement flowing down to the other two sites of service because the hospital is also for contract labor, aren't paying as much as they were a couple of quarters ago. So all of these dynamics will actually help free up some labor into the other sites of service but there definitely will be a lag. And as I said earlier, when that does happen, Teleflex is well positioned to take advantage of it.
Craig Bijou:
Okay. Thanks for that color, Liam. And then apologize for getting granular here. But you guys mentioned the overall business in September was stronger than July and August. So wanted to ask maybe specifically on UroLift. I know June was a tough month for UroLift but any color on the monthly trends within the quarter for UroLift sales?
Liam Kelly:
Yes, sure. So as expected, August was impacted by the vacation season and we knew that was going to happen. But we did see an uptick in the day rate in September as also was expected. So -- and as I said, we saw the improvement in staffing levels. So we're encouraged by the uptick in September coming out of the holiday season in our day rate and that's what is the basis for our guidance for Q4.
Craig Bijou:
Okay, thanks for taking my questions, guys.
Liam Kelly:
Sure.
Operator:
We now have Matthew O'Brien of Piper Sandler. Please go ahead when you’re ready, Matthew.
Unidentified Analyst:
Hi, good morning. This is Phil on for Matt. Thanks for taking my questions. Can you guys hear me all right?
Liam Kelly:
We can hear you, Phil. Thank you.
Unidentified Analyst:
Just to touch on UroLift again. I mean, do you expect the strength of trainings to continue through fourth quarter and into 2023 here? And then additionally, I understand that the timeline of visit recovery is a bit up in the air but do you expect more of a step function in terms of visits once they do return? Or will it be a slower ramp as patients return a little bit more slowly?
Liam Kelly:
So with regard to the training, the training was -- in Q3 was right in line with our expectations. So we're ramping to the traditional 400-ish docs that we would train in any given year. So we're on track for that. And that for us is encouraging because it lets us know that docs are still interested in the procedure. They want to take the procedure. We're moving from the early adopter to the fast follower and that is quite encouraging. With regards to visits, the first milestone for me, Phil, is to get to a flat visit year-over-year. We've gone through this year with minus 15, minus 12, minus high single digits. So we have to get the flat first before we get the normal cadence of increase. And even when we're flat year-over-year, that is still below 2019 pre-COVID. So there is a ways to go in the patient visits. And you are correct. Once patient flow starts to come back, there should be a lag thereafter. And then you should see momentum begin to build once the patients are back, visiting their urologists.
Unidentified Analyst:
Great and thanks for that color. And I guess just shifting gears, congratulations on the Standard Bariatrics acquisition. I was wondering if you would need any additional pieces to surround that asset? Or if you believe that it's -- it can exist in its current state? And I guess just broadly -- more broadly on M&A, what are your thoughts given pullback in valuations and your own leverage ratios?
Liam Kelly:
Yes. So Standard Bariatrics first, obviously, it's a great acquisition for us. We already have a significant call point in the -- with the bariatric surgeon. We sell our mini lap, our percutaneous surgical system. We sell the Weck EFx closure and we sell our cold ligation products. So we already have that call point around it. And this is an opportunity for us to double our sales force in that call point as the Standard Bariatrics and double the number of salespeople that are selling the Titan SGS as well. Regarding M&A, pro forma, we're at 1.9x levered. So we're in pretty good shape. We are active out there in the marketplace looking for assets. The team internally ran some analysis on the Standard Bariatrics acquisition because I'm taking from your question, should you do a share buyback given where your stock is at? And actually, if you're a short-term holder of Teleflex, the staff buyback in the first year might be preferable. But if you're a long-term holder for sure, over the 2, 3, 4, 5, 6-year horizon, it's a significantly better return on Teleflex using their balance sheet to do M&A, rather than do a stock buyback, even with our stock price where it is today. So we've run that analysis. We feel confident we can give shareholders a better return by continuing to bring in attractive M&A into the company, continue to expand Teleflex's reach into new and aligned procedures and that would be our mantra going forward and that's what we're going to execute towards.
Operator:
Thank you. Your next question comes from Lawrence Biegelsen of Wells Fargo. Please go ahead when you’re ready.
Unidentified Analyst:
Hi, good morning. This is Vick in for Larry. Just a couple from us. Can you provide us with a framework for 2023, not asking for a specific guidance but any sort of items you're aware of now like FX or inflation running through the P&L that you can share your preliminary thoughts on? And any reason why you don't think you'll be at 6% to 7%? And then I have a follow-up. Thanks.
Liam Kelly:
So with regard to what we know now, that's going to flow through the P&L for next year. Obviously, FX is going to be an impact. We had set up our plan this year. And we brought the -- in particular, the euro to the dollar which is our biggest exposure. We brought that to parity in Q2 for the remainder of the year. And we've updated that and that was one of the reasons for the $10 million call down on euro and other currencies moving because we realigned that rate. That would give you an average for the year of approximately 105 to the euro. And if it stays at parity or below parity, that's going to be an obvious headwind for the next year. We are seeing heightened inflation but we had built in incremental inflation into our LRP in the future. And the first year, your 2023 question, we'll get to that when we get to February, we'll give guidance for the first year of the LRP when we get to February. But as I said a little earlier, I'm still very confident on the overall 6% to 7%. And the addition of Standard Bariatrics just gives me even more confidence on that 6% to 7% over the LRP horizon.
Unidentified Analyst:
Great. And just a follow-up. Can you talk about MANTA penetration in the quarter? And how are you thinking about the rest of this year and potentially, next year? Thanks so much.
Liam Kelly:
Yes. So with MANTA, the penetration is really into the TAVR procedures, where about 75% to 80% of our procedures are done there and that continues to be a focus for us. As we head into next year, what we're really excited about, we've got a clinical study being done on top of the Karolinska one that I spoke about in the call and the Karolinska one was excellent because it basically shows, the adoption curve is really quick for MANTA. And even better, the complication rate is right in line with our original study that we did, the SAFE study. So that's really encouraging. Now we have another trial going on that's going to help with the positioning of MANTA and the use of ultrasound Doppler to position the product which should make it even easier for those surgeons to continue to use the product. With regard to penetration, we see that the penetration level obviously continuing to ramp. It's a $200 million to $300 million market and we're very early in the adoption curve. So we see no reason why that won't continue over a multiyear period.
Operator:
Thank you. We now have Anthony Petrone of Mizuho. Your line is now open.
Anthony Petrone:
Thanks and hope everyone doing well. And will be after hearing the name. So maybe, Liam, just a little bit on Japan and China, just on the cadence of actually physician training, urologist training in those markets. How do you expect that to proceed? You're doing about 400 a quarter in the U.S.? Is it really the same cadence in those markets? And maybe your early thoughts on 2023 when you think about contribution from Japan and China in UroLift. And I'll have one follow-up. Thanks.
Liam Kelly:
Yes, Anthony, welcome back. Good to have you back on the story. So just to be clear, we'll do around 400 a year in the United States rather than the quarter. In Japan, we're very early in the cycle. So we're really in a few major metropolitan areas. Obviously, Tokyo being one of them. We have added some additional sales reps in this quarter as we continue to prepare for 2023. And again, I feel really confident on the ramp at 1/3 of the size of the U.S. market. So next year, it should be something in the region of 1/3 of about $15 million, what we should expect from Japan. China, we'll do our first case this quarter. Obviously, we're starting in the private hospital sector. And again, we'll start in the major metropolitan centers. We will start in Shanghai, Beijing and Guangzhou and then we'll expand out beyond that. I would like to get the initial trainings done in China before we give too much more color on how many docs we can bring on. But we have identified a number of the key opinion leaders in China and that training will -- as I said, will take place during Q4. Excited about both. I think those are the markets that can really move the needle for UroLift. They're large enough. They've got -- Japan has good reimbursement. We will get reimbursement and put it on to the regional tenders in China, once we build some traction in the private markets and that will take us a few years to do that.
Anthony Petrone:
Great. And then the follow-up maybe for Tom. Just when we think about inflation for next year, I think previously, there was a dollar number that we should be thinking about that will roll into next year. Some companies have given that dollar amount. So just wondering if there's an updated view on how inflation rolls in, next year? And when we think about the restructuring programs and offsets, if you can provide some color on potential offsets? Thanks again.
Thomas Powell:
Sure. Well, as we mentioned in our prepared remarks, inflation continues to exist for us. As we think about the components of it, we're actually seeing some improvement in sea freight and we had expected that all along this year. And so we're seeing the costs of freight going down quarter-over-quarter. Materials, however, continue to be at elevated rates. We haven't seen that stabilize quite yet or return to a normalized level. So we will continue to expect to have inflation in our numbers. And historically, we've always had a level of inflation. I would say that this year, it was higher than typical. We will have some rolling into next year as a result of just how we capitalize our inventory and how that rolls off the balance sheet. But right now, we're not in a position to give specific guidance for inflationary pressures for next year. Now with that being said, there are a number of offsets. We talked about pricing which we were very successful this year in getting pricing out there to help offset some of the inflation pressures. Restructuring programs are -- that are currently announced will also provide a benefit in next year. And as we look out to the next couple of years, we expect to realize about 0.5 point in margin expansion from restructuring just next year with a full point over the next couple of years. So there is a nice benefit from restructuring, from pricing. Underlying in our business, we still have a nice mix benefit that we're seeing come through from our high-growth portfolio, as mentioned. They grow at a faster rate and carry a higher margin. So that's an underlying mix benefit that we continue to see and expect to see for the number of years over the LRP. And as UroLift continues to recover, we'll expect to see more and more contribution from that business unit as well on the margin line. So again, we'll give specific numbers on inflation as we get to the guidance for 2023.
Operator:
Thank you. Our next question comes from Richard Newitter of Truist. Please go ahead.
Richard Newitter:
Hi, thanks for taking the questions. Maybe just -- actually two on our UroLift here, sorry to harp on your left. I know it's a lot of focus there already but I think it's so important for investors. You've mentioned the CAGR, granted it's off of a potentially lower starting point. I'm just curious, to get to that 15%, even if it is off the lower starting point, can you give us a sense of what the minimum level of the U.S. portion of that needs to grow? In other words, do you need to be back to double-digit U.S. growth over the CAGR in order to get there? Or is there enough room that you don't need to rely on that in the international contention there? And then I have one follow-up.
Liam Kelly:
Well, Rich, clearly because international has such a lower base, the percentage growth in international is going to be significantly greater than the U.S. So by logic, you will tell you that to get to a 15% CAGR, that the U.S., just by definition, is going to be lower than that 15% in that regard. I still believe that with the number of men that are out there, the 12 million in the United States with BPH and the 1.5 that have BPH and are in the drug dropout category, I still think that growth within the U.S. is well within our reach as an organization. And as I've said a few times in the call, we're well positioned. We got our sales force fully staffed. We got DTC going. We just are back doing a BPH Summit. We did a live one. That's a nice inflection normally for us to get more interest. And we're going to have one in Japan in the fourth quarter and then we'll have a number of them next year again. So things seem to me like getting more towards normal, at least in that regard, regarding access. And to answer your question, so the U.S., for sure, doesn't have to grow at 15% for the CAGR to be 15%.
Richard Newitter:
Okay. Yes. I was more just asking because I have to get back to double digits, if you can answer that. But the second question, too, for me on UroLift was, I just want to make sure I understand the staffing issues in the office setting. My understanding was, doctors tend to schedule their UroLift procedures on one or two operating days. So I'm just trying to get a sense for how that might be the mix of where the UroLift's volumes coming back? Is it more -- you're talking about the higher volume accounts that are maybe doing many more UroLift’s, so they just can't get back to their -- meet the demand levels because they're doing multiple days per week of operations? Or what exactly am I missing if the office setting should be easier from a scheduling and patient management standpoint? Thanks.
Liam Kelly:
Yes, you're right, Rich. It's easier from a scheduling and that's why urologists like to do the procedure there because they're in control of it. But what you're missing, I think, in your analysis, Rich, is everything that happens before the appointment gets scheduled. So the patient has to come in, has to see the urologists. They have to fill out an IPSS score card. They may do some additional diagnostics on them in order to determine the bladder health of the patient. And then they will definitely do cystoscope, all of that requires labor. Every step along the way requires labor. It's not just about the procedure itself, it's about what happens to the patient flow as they work their way through to get to the endpoint of the procedure and that's what's causing the impact. As I said, 61% of office-based urologists in our survey clearly identified, they had staffing charges. And I was down south in just about -- just over a month ago, visiting with urologists, every one of them mentioned staffing shortages, every one of them.
Operator:
Thank you. Your next question comes from Michael Matson of Needham & Company. Your line is open.
Michael Matson:
Yes, thanks. I guess I have two questions. I'll just go and give to you both now. So first, with UroLift, with regard to the sales force, has there been any changes, disruption, turnover in that sales force? Have you added headcount this year? And then the second question is just on Standard Bariatrics, is this -- I mean, I totally understand the opportunity on the sleeve gastrectomy market and bariatrics but is this sort of a platform technology that would enable you to offer like a full range of stapling products over time to kind of enter that duopoly market?
Liam Kelly:
Well, I think that we already have a series of products within that call point. Obviously, it's a fast-growing market. It's a market that's going to continue to grow as we as a society continue to eat more of the wrong stuff. So we do see this as an opportunity for us to continue penetration within the bariatric market that there are some aligned technologies that may be of interest to us as we go deeper into this. It is an area of interest for Teleflex and always has been, as I said earlier, we've got our cold ligation clips in there. We got our facial closure in there and we got our mini lab that we -- our sales force is in there. Regarding turnover, like all medical device companies, we experienced heightened turnover in 2021 right across the border in Teleflex and in UroLift. Right now, we have a very stable sales force in the UroLift area. We have, I think, right now as I sit here today, I think we have about four or five open territories within the business units. And we feel really confident that we're well poised to be ready for the -- for when the market recovers.
Michael Matson:
Okay, thanks. Just on the stapling question, I guess what I was getting at is, would you look at offering staples that can be used outside of bariatrics, like the broader kind of surgical staple market?
Liam Kelly:
I'm sorry, Mike, I missed the question.
Michael Matson:
Yes, no problem.
Liam Kelly:
We already sell staples in our general surgical portfolio but they're skin staplers. And obviously, our Hemo-lok, our Horizon are both, cold and metal ligation clips. So don't see ourselves really going up against the big guys to try and take them on, in more broad stapling, Mike. It's -- the reason we went into this one is because it's so differentiated. It speeds up the procedure. It gives a better outcome for the patient and gives a better outcome for the docs. So this is probably the reason we went into this area of stapling.
Operator:
Thank you. You have no further questions. So I would like to hand it back to Lawrence Keusch for some final remarks.
Lawrence Keusch:
Thank you, Abrika and thank you to everyone that joined us on the call today. This concludes the Teleflex Inc. third quarter 2022 earnings conference call.
Operator:
Thank you for joining. This does conclude today's call. Thank you for joining and thank you for your participation. You may now disconnect your lines.
Operator:
Good morning, ladies and gentlemen. Welcome to the Teleflex Second Quarter 2022 Earnings Conference Call. [Operator Instructions]. Please note that this conference call is being recorded and will be available on the company's website for replay shortly. And now I'll turn over to Mr. Lawrence Keusch, Vice President of Investor Relations and Strategic Development. Please go ahead.
Lawrence Keusch:
Good morning, everyone, and welcome to the Teleflex Incorporated Second Quarter 2022 Earnings Conference Call. The press release and slides to accompany this call are available on our website at teleflex.com. As a reminder, this call will be available on our website, and a replay will be available. Please refer to our press release from this morning for details on how to access the replay. Participating on today's call are Liam Kelly, Chairman, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks, and then we'll open the call up to Q&A. Before we begin, I would like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include but are not limited to factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. During this conference call, you will hear management make statements regarding intra-quarter business performance. Management is providing this commentary to provide the investment community with additional insights concerning trends, and these disclosures may not occur in subsequent quarters. With that said, I'll now turn the call over to Liam for his remarks.
Liam Kelly:
Thank you, Larry, and good morning, everyone. It's a pleasure to speak with you today. For the second quarter, Teleflex revenues were $704.5 million, a year-over-year decline of 1.3% on a reported basis and an increase of 2.3% on a constant-currency basis. Adjusted earnings per share increased 1.2% year-over-year to $3.39. In reviewing the quarter, we posted solid execution across the vast majority of Teleflex, with nearly 90% of the collective business driving constant-currency revenue ahead of plan. Volumes have continued to recover in the U.S., EMEA and Latin America as COVID hospital admittance have declined from peak levels earlier this year. However, the revenue results were below our expectations as UroLift sales did not rebound to the level we had anticipated. Excluding UroLift, constant-currency growth in the quarter was 4% year-over-year as the remainder of the business collectively outperformed our forecast for the quarter, albeit with some pluses and minuses across the portfolio as we navigated a dynamic environment. Moreover, when adjusting for the impact of the Respiratory divestiture and UroLift, the rest of the business grew 5.2% constant currency. This solid performance continues to reflect the benefits of a diversified portfolio that has been purposely built and is primarily targeted to the care of the critically ill patients. In the quarter, our high-growth portfolio, which includes UroLift, MANTA, hemostatic products, EZ-IO, OnControl and PICCs, maintained momentum across the majority of growth drivers. Although UroLift declined 13% year-over-year in the second quarter, the remainder of products in the high-growth portfolio increased in excess of 20%. Although the second quarter presented some additional challenges, we remain confident that the environment will continue to improve over time, including for the most elective surgical procedures like UroLift. Moreover, we will continue to execute against our strategy that we articulated at the May Analyst and Investor Day. We remain focused on strong execution and funding our existing growth drivers. We will drive geographic expansion with a particular emphasis on the Asia Pacific region. Margin expansion remains an opportunity as we improve the mix of our high-growth portfolio and generate cost savings. We remain good stewards of our capital with a prioritization on internal investments to ramp our innovation engine and M&A. Our business development team is active with opportunities in scale acquisitions, late-stage technology and tuck-ins. We believe that the external environment for deals is improving, and we are prepared with a strong balance sheet to take the cues on opportunities that meet our acquisition criteria. In fact, during the second quarter, we completed a product tuck-in acquisition in our interventional business and closed on a distributor-to-direct conversion early in the third quarter. Although both transactions are immaterial to Teleflex in 2022, we remain committed to continued execution of our M&A strategy. And finally, we will continue to advance our TSR and DE&I initiatives. I would call your attention to our soon-to-be-public 2021 Global Impact Report, which highlights our progress as an organization to advance our corporate social responsibility agenda. Now let's turn to a deeper dive into our second quarter revenue results. I will begin with a review of our reportable segment revenues for the second quarter. All growth rates that are referred to are on a constant-currency basis unless otherwise noted. Americas revenues were $412.7 million, which represents a 0.3% decline year-over-year against nearly 32% growth in the year-ago period, but reflecting improving growth trends on both a 2-year and 3-year basis in the quarter. Surgical was the biggest contributor to growth, offset by decline in Interventional Urology. The headwind associated with the Respiratory divestiture to the Americas group was minimal in the quarter. EMEA revenues of $145.2 million increased 3.4% year-over-year. The growth was broad-based during the quarter with Anesthesia, Surgical and Interventional Products making notable contributions. Once again, procedure volume strengthened year-over-year as countries across the region moved past COVID-related restrictions. Excluding the impact of the Respiratory divestiture, revenues rose 6.7% year-over-year. Turning to Asia. Revenues were $76.6 million, increasing 1.8% year-over-year. Southeast Asia and Korea were strong contributors to the performance in the quarter. Growth in China was negative year-over-year due to the impact of the COVID lockdown during May and June. Excluding the impact of the Respiratory divestiture, Asia revenue for the second quarter rose 7.3% year-over-year. Let's now move to a discussion of our second quarter revenues by global product category. Consistent with the prior comments regarding our reporting segment, commentary on global product category growth for the second quarter will also be on a constant-currency basis and ranked by the size of our business units. Starting with Vascular Access. Revenue increased 1% to $163.9 million. The performance in the quarter in part reflects the year-over-year reduction in COVID intensive care unit patients and a decline in overall intensive care unit visits. Looking forward, our category leadership in central venous catheters and midline, along with our novel coated PICC portfolio, continue to position us for durable growth. Based on our second quarter performance, there is no change to our double-digit growth outlook for PICC in 2022 as we invest behind our differentiated portfolio. Moving to Interventional. Revenue was $114.4 million, up 5.3% year-over-year against a tough comparison of 31% growth in the second quarter a year ago. We are pleased with the performance in light of the industry challenges given the contrast shortage. For Teleflex, the contrast staff shortage impact was immaterial, and we see the situation continuing to improve. We remain on track to achieve high single-digit to low double-digit constant-currency growth in our Interventional business for 2022. For MANTA, our large bore closure device, we see approximately 50% growth on a full year basis. Now turning to Anesthesia. Revenue was $104.7 million, up 14.4% year-over-year, despite a challenging year-over-year comparison. Of our larger franchises, hemostatic product, atomization and LMA reusable mask all contributed to growth in the second quarter, partly offset by lower sales of tracheostomy products. Hemostatic product revenue increased sequentially and exceeded expectations for the quarter. In our Surgical business, revenue was $99.6 million, representing 5.9% growth year-over-year after a 39% constant-currency comp last year. Among our largest product categories, instruments led the growth for the quarter. Metal and polymer ligation kits maintained growth despite the tough year-over-year comps and the COVID-related lockdown in China during the quarter. For Interventional Urology, revenue was $79.8 million, representing a quarter-over-quarter increase of 6.9% but a decrease of 13.2% year-over-year and below our internal expectations. We did not see the recovery in the operating environment in our Interventional Urology business that we were expecting during the second quarter. April was somewhat faster than our plan. We saw some stabilization in May offset by the COVID-19 impact. But finishing out the quarter, June was unexpectedly weaker and well below our expectations. Looking at the revenue composition of UroLift, we saw year-over-year revenue declines in all sites of service during the quarter, including hospital, ASC and physician's office. We have identified a number of factors that contributed to the revenue performance in the quarter. First and foremost, the broad-based recovery in overall urology procedures that we assumed in our guidance did not materialize. Most investors familiar with Teleflex will be aware that urology procedures in 2021 remained below 2019 level. We had anticipated patient visits to urology practices to improve year-over-year as we moved through 2022. However, we actually witnessed a drop in patient flow to urologists in the second quarter, which impacted UroLift procedures. In addition, while BPH remains in the top 4 disease states treated by urologists, higher-acuity conditions that require immediate attention such as kidney stones, blood in the urine and prostate cancer continue to be prioritized. Second, UroLift procedures continue to be hindered by COVID disruptions, including procedure cancellations in late May and the continuation of staffing shortages. We conducted an internal survey with just over 100 urologists responding in the second quarter. Of the respondents, over 50% indicated that they were understaffed. Third, we initiated a voluntary recall in June of certain identified lot of our UL400 UroLift System, which is a first generation UL1 device. Although immaterial to Teleflex, this created some disruption for the UroLift sales force during the second quarter as they managed the recall activities. The UroLift issue was brought to our attention through our internal quality monitoring process, which identifies the potential where, upon implant deployment, the affected devices may not properly deliver an implant. The issue is immediately obvious to the surgeons and impact implant delivery at the time of the procedure. It has no impact on a UroLift implant once it has been properly delivered and tensioned. As a result of our root-cause investigation of the issue, we have isolated an out-of-specification product tool on 1 production line at 1 facility. We otherwise remain in production for the UL400 device. We have adequate levels of inventory of unaffected products available so we do not foresee any supply constraints associated with providing replacement products for our customers affected by the recalls or in satisfying future customer orders. To confirm, the recall has not had and is not expected to have a material impact on our consolidated financial results or operations. Importantly, the UroLift 2 system is not subject to recalls due to a different manufacturing process. OEM revenues increased 17.6% year-over-year to $70 million due to strong double-digit growth across all product categories. Our order book remains well positioned as customers recognize our broad competencies with competitive capabilities across our market. I would like to emphasize that the acquisition of HPC has been an excellent addition to the business. The integration has been completed, and we are participating in fast-growth markets for thin-wall interventional microcatheters to access small vessels and fine wire for sensing and ablating technology. And finally, our other category, which incorporates sales of respiratory products not included in the divestiture to Medline, urology care and manufacturing and supply transition agreement revenues related to the Respiratory business divestiture. Second quarter other revenues declined 10.9% to $72.1 million year-over-year. The decline reflects the loss of revenue due to the divestiture of respiratory products, partly offset by manufacturing and supply transition agreement revenues. We continue to expect all MSA revenues will phase out at the end of 2023. That completes my comments on the second quarter revenue performance. Turning to some commercial and clinical update, and starting with UroLift. With respect to our market development objective for UroLift, we were pleased with our progress during the quarter. We continue to get excellent feedback from surgeons regarding UroLift 2 as well as the UroLift Advanced Tissue Control for use in obstructive median lobe. We believe that the launch of the UroLift 2 and the Advanced Tissue Control will enable us to further engage with surgeons and drive utilization deeper into our labeled indication. In fact, during the second quarter, we have seen procedure growth in accounts that have converted over to UroLift 2 that is greater than for accounts that have not yet made the switch. Based on our progress at the end of the second quarter, we are confident in our ability to convert the vast majority of our U.S. customers to UroLift 2 by the end of 2022. In turn, we expect a 400 basis point margin expansion for Interventional Urology associated with the UroLift 2 conversion when our U.S. base is fully switched over. In addition, we have seen that our patient response to our direct-to-consumer programs are running ahead of our plan for the first half of 2022. We were also pleased with our new surgeon training in the first half of the year. Of note, during the second quarter, we hosted our first BPH summit since the pandemic began, with over 80 physicians attending the live events. And given that recent success, we will be hosting another BPH summit in the second half of 2022. From a clinical perspective, UroLift remains differentiated from other outpatient BPH treatments with strong clinical results, studies showing rapid symptom relief and recovery, no new sustained sexual dysfunction and durable results. Our review of the clinical data from recent urology meetings indicate that real-world results continue to approximate the LIFT pivotal trial with regard to retreatment rate. We recently highlighted a number of studies at the European Association of Urology Annual Meeting. Of note, our real-world retrospective study included patients with varying prostate sizes and morphologies across 22 international sites. Our retrospective review of UroLift cases was performed after subdividing patients according to prostate size, ranging from less than 30 ccs to more than 80 ccs, and obstructive median lobe and lateral lobe obstructions. IPSS improved significantly for all volume groups at 24 months. Now turning to an update on our international expansion strategy for UroLift. We are in the early stages of a multiyear multi-geography international market expansion, which is expected to be a meaningful driver of growth in the coming years. The launch of UroLift in Japan, which began in April 1, is tracking to our plan, and we are very encouraged with the results thus far. We continue to engage with key opinion leaders, and cases are continuing to ramp up. The feedback from these initial cases has been overwhelmingly positive, and we are again getting strong responses to the performance of the UroLift 2. Indeed, I recently met personally with 19 urologists during a recent visit to Japan and was very encouraged by the commentary following their initial UroLift cases. Although we consider 2022 as a building year for Japan, we remain excited about our prospects for 2023 and beyond. Japan remains an important long-term opportunity for UroLift with a $2 billion TAM, and we are excited to bring this clinically beneficial treatment to those suffering with BPH. Shifting to other international geographies. We remain on track for our expected UroLift commercial milestones, including the launch of UroLift in China and updated reimbursement in France during the fourth quarter. Moving on to some reimbursement update. On July 7, CMS issued its 2023 physician fee schedule proposed rule, which was in line with our expectations. CMS proposed a reduction in the conversion factor by 4.4% in 2023 as it continues the four-year cave-in associated with the 2022 final rule. We will continue our efforts to engage CMS alongside a broad number of stakeholders to provide our position that the cut reimbursement for over 600 common office space procedures will result in migrating to higher-cost sites of service and limit options for senior citizens in the United States. CMS also issued its 2023 outpatient prospective payment system proposed rules, which was published on July 15. In this case, the facility fee was increased by an average of 2% in the ASC and 3% in the hospital outpatient setting. These rules are open to public comments through September 2022 and do not come into effect until 2023. Considering the proposed changes to the 2023 physician fee schedule and OPPS, UroLift continues to be the most profitable minimally invasive treatment adoption for BPH that does not require an overnight stay in the hospital. Turning to our Interventional business. We've announced the MANTA Ultra Study in June. This study, which is expected to enroll up to 150 patients in 15 investigational sites, is intended to demonstrate the safety of MANTA ultrasound-guided closure, without dependence on pre-procedural depth locator measurements. As noted in our press release announcing the study, the occurrence of access site complications is known to be associated with higher rates of morbidity and mortality and increased costs associated with prolonged length of stay. In addition, we received Health Canada approval for MANTA in May, which will help us continue to build momentum for our large bore closure device globally. That completes my prepared remarks. Now I would like to turn the call over to Tom for a more detailed review of our second quarter financial results. Tom?
Thomas Powell:
Thanks, Liam, and good morning. Given the previous discussion of the company's revenue performance, I will begin with margin. For the quarter, adjusted gross margin totaled 59.6%, a 30 basis point decrease versus the prior year period. The year-over-year decrease was a result of volume and mix; incremental inflation in freight, raw materials and labor; partly offset by favorable pricing. Of note, our price strategy continues to maintain its traction in the second quarter. Adjusted operating margin was 27.5% in the second quarter. The 70 basis point year-over-year decline was the result of the lower gross margin, lower leverage across our expense base and planned investments in the business for our growth drivers. Net interest expense totaled $11.2 million in the second quarter, a decrease from $15.9 million in the prior year period. The year-over-year decrease in net interest expense reflects savings from the early redemption of the 2026 senior notes and the impact of reductions in outstanding debt using proceeds of the Respiratory divestiture and operating cash flow. Our adjusted tax rate for the second quarter of 2022 was 12% compared to 14.4% in the prior year period. The year-over-year decrease in adjusted tax rate is primarily due to further enhancements through tax efficiencies of our global structure, partly offset by tax expense arising from the new provision of the U.S. tax law requiring the capitalization of certain R&D expenses. At the bottom line, second quarter adjusted earnings per share was $3.39 or an increase of 1.2% versus prior year. Normalizing for foreign exchange, incremental inflation and the Respiratory divestiture implies underlying adjusted EPS growth in the low double-digit range year-over-year. Turning to balance sheet and cash flow highlights. Cash flow from operations in the first half was $101.9 million compared to $265.1 million in the prior year period. The decrease was primarily attributable to higher tax payments and unfavorable changes in working capital driven by higher payroll and benefit-related payment. Also impacting cash flow was an increase in our inventory level to provide support for future growth and to minimize the potential impact from the supply chain disruption. Moving to the balance sheet. Our financial position remains healthy. At the end of the second quarter, our cash balance was $308.1 million as compared to $445.1 million at the end of 2021. The reduction in cash on hand is due to $135.5 million payment in the second quarter to reduce our revolver borrowing. Subsequent to the debt payment, our floating rate debt now accounts for 42% of the total debt outstanding. Net leverage at quarter end was approximately 1.8x, which remains well below our 4.5x covenant. Now moving on to our 2022 guidance. We are reducing our 2022 constant-currency revenue growth guidance to 3.25% to 4.25% versus 4% to 5.5% previously. The revised constant-currency revenue range represents a $21 million to $35 million reduction versus our prior rate or $28 million at the midpoint. This contemplates a reduction in our outlook for UroLift revenue partially offset by strength in the remaining businesses. When including the impact of the Respiratory divestiture and normalizing for 1 less trading day, the underlying growth projection of the business remains over 5% year-over-year when considering the midpoint of our 2022 constant-currency revenue growth guidance. On foreign exchange, the dollar has been meaningfully strengthening in the second quarter, including the euro exchange rate where we are most exposed. Our initial guidance for 2022 assumed a dollar to euro exchange rate of 1.12 for the year. Our guidance now assumes an average euro exchange rate of 1.05 for the full year 2022 with parity for the second half. Our guidance now also assumes that other exchange rate have been adjusted to reflect the current rate environment. Revised foreign exchange assumption represents an additional $55 million headwind to reported revenue. For the year, the expected impact of foreign exchange is now a revenue headwind of approximately 3.7% or $100 million versus 1.7% and $45 million previously. We now expect reported revenue growth of negative 0.45% to positive 0.55% in 2022, implying a dollar range of $2.797 billion to $2.825 billion. I will now turn to our outlook for UroLift. Given the first half results and our expectation for sequential revenue increase in the second half of the year, we are now assuming that 2022 UroLift revenue will be down slightly year-over-year or approximately $335 million versus the prior guidance for 15% growth. This revised assumption reflects a $58 million reduction in UroLift revenue compared to what our prior guidance range had assumed. As we look into the second half of 2022, we expect an improving environment for UroLift as the macro environment improves, utilization picks up and newly trained surgeons ramp up. Of note, our current UroLift revenue outlook for 2022 assumes growth in the second half with a sequential revenue increase in the third quarter and a further sequential increase in the fourth quarter. We have not made any changes in assumptions for the international UroLift outlook as we remain on track with our rollout in Japan, the launch in China and the reimbursement update in France. Turning to the middle of the income statement. We expect gross margin of 59% to 59.5% for 2022. Although freight and labor inflation remained largely in line with our expectations, raw material costs are turning out to be higher than previously projected. Accordingly, we are now projecting an inflation headwind in 2022 of 100 basis points versus 70 basis points previously. Recall this is over and above what we typically see for inflation in any given year. Our latest outlook captures our view for the remainder of the year and does not assume a significant improvement in overall material inflation. Importantly, price remains an inflation offset, and we are confident in our ability to achieve at least 50 basis points of price per year. As a matter of course, we will continue to assess our global pricing and make adjustments as opportunities arise. Relative to operating margin, we now expect operating margin to fall within the range of 26.75% to 27.25%. Our guidance reflects the anticipated gross margin and lower leverage across our operating expense base. Moving to earnings. We are reducing our adjusted earnings per share guidance for 2022 to $13 to $13.40 from a previous range of $13.70 to $14.30, which amounts to a 2.5% decline at the low end and a 0.5 point increase year-over-year at the high end. In bridging from our previous adjusted EPS guidance, we note a $0.50 reduction associated with our revised outlook for UroLift, foreign exchange is now a headwind of $0.46 versus prior assumption of $0.20 and incremental inflation is now a headwind of $0.47 versus $0.33 previously due to the increased raw material costs. The additional headwinds are partially offset by improved operational outlook for other areas of our business. Additionally, our guidance includes a headwind for the Respiratory divestiture of $0.15. Normalizing for incremental inflation, foreign exchange and the Respiratory divestiture, implied underlying adjusted EPS growth at the midpoint of guidance is a high single-digit range year-over-year for 2022 and reflects the benefits of our diverse growth drivers and ability to grow earnings in a period of significant macro challenges. That concludes my prepared remarks. I'd now like to turn it back to Liam for closing commentary.
Liam Kelly:
Thank you, Tom. In closing, I will highlight our 3 key takeaways for the second quarter and our 2022 outlook. First, our diversified product portfolio enables Teleflex to deliver constant-currency growth of 2.3% in the second quarter despite meaningful macroeconomic headwinds. Moreover, when adjusting for the headwind from the Respiratory divestiture, the underlying business growth was 3.5%. Second, we will continue to effectively manage the business and look for ways to minimize incremental headwinds from inflation and supply chain challenges. While the near-term UroLift revenue results are disappointing, our guidance implies an improving growth trajectory in the second half of the year. Moreover, we are well positioned when the macro headwinds for the urology market abate. Third, we continue to execute against our long-term growth strategy. We will continue to incrementally invest in our high-growth portfolio and drive dependable expansion in our durable core portfolio. We have levers in place to drive further expansion in our margins, and our balance sheet is in a solid position with leverage at 1.8x, providing ample financial flexibility for our capital allocation priorities, including mergers and acquisitions. That concludes my prepared remarks. Now I would like to turn the call back to the operator for Q&A.
Operator:
[Operator Instructions]. Our first question will come from Cecilia Furlong from Morgan Stanley.
Cecilia Furlong:
Liam, I did want to start with UroLift. And really looking to just get a bit more color in terms of how you're thinking about the back half, the revised guidance, but either contributions from backlog coming back in, either ramping volumes under your prior high-volume utilizers, DTC, just kind of a balance of how you're thinking about the environment and then really also just your longer-term view on that 15% growth for the overall business, how you're thinking about potential backlog recapture in '22 and beyond.
Liam Kelly:
Okay, Cecilia. So let's start with the full year outlook for UroLift. Obviously, our prior guidance assumed 15% growth, which would have revenue of $393 million. And due to the current market environment that I went through in my prepared remarks, we are now expecting $335 million, representing a reduction of $58 million or approximately 2% for Teleflex in our entirety. I would like to point out, before I get into the pieces of UroLift, that our constant-currency call-down at the midpoint is 1%, which is an indication that the rest of the portfolio is outperforming by approximately $30 million. And I would also point out that a good portion of this outperformance is coming from the high-growth, high-margin portfolio such as hemostats, intraosseous and PICCs and the like. The UroLift updated guidance, to answer your question, is not assuming any significant improvement in the operating environment. Essentially, we are taking our quarter 2 revenue run rate and assuming sequential improvement into Q3 and further sequential improvement into Q4. This would obviously imply positive growth in the back half of 2022. Now I would like to point out as well that the updated guidance for UroLift is based on slower urology procedural recovery trends in the U.S. Our assumptions for OUS have not changed in that regard. Regarding the backlog, we are not assuming that there is a backlog that will come back in, in the latter half of the year. I think our observation is that the UroLift procedure is still -- is a very postponable procedure and there's a reluctance of patients still to come back to the urologists. And there's also a staffing shortage, as I went through in my prepared remarks. So that's our assumptions in the back half, Cecilia, for UroLift and an update on the call-down for the full year.
Operator:
Our next question comes from Jayson Bedford from Raymond James.
Jayson Bedford:
Can you hear me okay?
Liam Kelly:
Yes, we can hear you, Jayson. Thank you.
Jayson Bedford:
Maybe just a follow-up question on UroLift. I think you mentioned in the script that you're seeing better utilization in those accounts who are using UL2. And I'm just -- there's a lot of reasons for that, but I'm wondering what initiatives have you put in place to maybe accelerate conversion to UL2.
Liam Kelly:
So Jayson, we're very pleased with the rate of conversion that we're seeing right now. We are actually slightly ahead of our plan -- our internal plan that we laid out at the beginning of the year. What we're seeing is that when surgeons move over to the UL2, it's also an opportunity for us to introduce the Advanced Tissue Control. And the combination of those 2 new products is actually driving greater throughput in those practices. It's a combination of the sales force reengaging with the surgeon. And it's also a combination of expanding the size and complexity of prostates that surgeon is willing to treat because the outcomes on the UL2 are actually better than the UL1, and obviously, they feel much more comfortable doing median lobes with the Advanced Tissue Control. So we're ahead of our plan, and we do envision having the bulk of the North American -- the U.S. market converted by the end of this year. And that will also result obviously in that 400 basis points in margin expansion for the UroLift products.
Jayson Bedford:
And just broadly, Liam, has the UroLift strategy changed at all over the last 6 months? Meaning -- you came out with a newer strategy at the beginning of the year. Obviously, it's been a bit slower. Has the strategy been tweaked at all?
Liam Kelly:
So the strategy is as it was because it is working insofar as we did see sequential improvement from Q1 to Q2. UroLift actually grew 7% quarter-over-quarter. And we have to bear in mind they had a really tough comp in the prior year, it grew 120 -- over 120% in the prior year, was below our expectations. But what we're seeing with physicians is that they are actually -- the new docs that are trained -- we're actually seeing an improvement in the cases per physician from the new docs trained. And we've also brought on a larger number of high-volume docs within quarter 2. So therefore, that's what gives us the encouragement for the improvement -- the sequential improvement in Q3 and the further sequential improvement in Q4, Jayson.
Operator:
Our next question comes from Matthew O'Brien from Piper Sandler.
Matthew O'Brien:
Just to continue along the UroLift questioning. I'll ask my questions upfront. Liam, going down $60 million for the year roughly for UroLift, how much of that is just the volume impact that you're seeing on the folks going into urologists versus maybe losing a few people because of the recall or competitive launches versus reimbursement headwinds? And then just to be -- the second question, just to put a finer point on it, can you still grow UroLift 15% in '23, '24 and '25 like you mentioned at the Analyst Day?
Liam Kelly:
Okay. So there's a lot in that question. So we don't believe the reimbursement is having an impact. We know that it's not competitive pressures that's having an impact. The impact of the recall was pretty minimal, Matt. There were -- there was some sales force disruption. We did have to swap out some product from the customer and get new product in there and get the count. So there was that disruption. I will tell you -- when I look at the performance of the UroLift in the year, I will tell you that what we are seeing is a drop-off in patient throughput and in-person visits to urologists in Q2 versus Q2 last year, and that's compounding the drop that we saw in 2021 versus 2020 -- 2019. We're also experiencing staffing shortages. We did an internal survey of over 100 urologists, and over 50% of them cited staffing shortages within their practices. So that is a compounding issue. We firmly believe that the end market conditions is what's driving the volatility out there. And as I said to Cecilia, our observation is this is a very postponable procedure. You're not going to die because you didn't have your BPH treated. Regarding the longer term and your question regarding the LRP, just to level set everybody, the LRP assumes a CAGR of 6% to 7% for Teleflex and a 15% CAGR for UroLift. Using 2022 as the jump off, and I think that's an important point to reflect on, I remain confident in the plans we outlined during our Investor Day. Ex UroLift and the Respiratory divestiture, our durable core grew 4% in Q2. And also if you look at Q2 ex UroLift, our actual growth accelerated. And again, if you exclude the Respiratory divestiture, we went from 4.5% in Q1 to 5.2% in Q2. So the rest of the -- 90% of the business is performing very well. Now while UroLift did decline in Q2, I think Teleflex, we are very well positioned when the BPH market recovers. Our sales force is fully staffed and prepared for the market recovery. The market is still massive. There's -- the U.S. market is $6 billion and another $6 billion overseas. And we have the market-leading minimally invasive technology, immediate improvement, no sexual dysfunction, no need to wear a catheter. And as I said in my prepared remarks, we expect sequential improvement in Q3, further sequential in Q4, and this will obviously help our run rate into 2023. And we are -- even though we didn't change our guidance in the year for the international markets, we are continuing with our international expansion. Japan is going very well. China and France will -- should kick in, in Q4. We should get reimbursement in France in Q4. Italy and Spain, we continue to see the markets region by region. And in '23, '24, you'll see Germany, Taiwan, India, and we should get Brazil reimbursements at the back end of '24. So that's why I feel confident in the overall LRP we laid out and obviously, the CAGR for UroLift in that LRP.
Operator:
Our next question comes from Shagun Singh from RBC Capital Markets.
Shagun Chadha:
Liam, Tom, I know it's early, but could you provide some color beyond 2022? UroLift has been a major growth driver for you guys. It's part of the thesis that gets you to your target of 6% to 7%. How concerned are you of an economic slowdown and the impact on that business? How are you thinking about M&A to further boost or even maintain this growth trajectory longer term? And then if I could just ask a question on the macro items, FX and inflation. What have you assumed? What impact does it have on EPS in 2022? And how much of it flows through into '23?
Liam Kelly:
Okay. I'll ask Tom to answer the FX and inflation. I'll take the couple of macro questions. So in relation to if we enter into a recession, I think that Teleflex is well positioned. Normally, medical devices -- no industry is immune to a recession and the impact, but I think medical devices in general have been cushioned from the impact of a recession. I think Teleflex in particular will be even more cushioned than other types of medical device company. And the reason I say that is that Teleflex, our whole portfolio is skewed towards the elderly population. And normally, when you go into -- if you look at the last recession and if you look at unemployment rates -- and the reason I'm citing unemployment rate is because it impacts insurance for those individuals. So if you look at the last recession, unemployment went up to about 11%. But if you look at the demographics, those over the age of 55, unemployment was about 7%. And it was double that for those under the age 55. And because our portfolio is skewed towards that population, I think we would be somewhat -- not completely insulated but somewhat protected from a recession. Regarding that question specific to UroLift, with 12 million men in the United States suffering from BPH and 100 million globally, there's enough of a patient population there to continue to grow UroLift even in that type of an environment. Regarding your question on M&A in the current environment, obviously, interest rates have gone up so the cost of funding has increased. I do think though that the environment is more receptive to more appropriate valuations right now than it has been at any time in the past. And as I said in my prepared remarks, we are active out there right now. We feel good about the environment. Our leverage is 1.8x so we have firepower. We are chasing assets at the moment. We are looking at scale transactions, tuck-in transactions. And as you heard in my prepared remarks, we announced a late-stage technology and a dealer to direct, not that material for Teleflex but nonetheless an indication that we're active out there in the market looking at M&A in this current environment. And I'll ask Tom to answer the FX and inflation question. If you don't mind, Tom.
Thomas Powell:
Absolutely. So on the FX front first. So the impact for the year right now is to reduce our revenue by approximately $100 million. We had previously expected it to be a $45 million impact, so you've got an incremental $55 million as we think about rates where they currently are as of this week. On the earnings impact from FX, that's up to $0.46 for the full year. It was $0.20 previously. As we think about next year, obviously, I'm not able to estimate what currencies will become early next year. But assuming they're at the same level as they are today, what we'd see is a little bit of an incremental impact because the first quarter was stronger and the second quarter was stronger than where they are today. Again, we'll have to wait and see what currencies do next year to answer that question. On the incremental inflation, we're now expecting an inflationary impact of $0.47 to earnings versus $0.33 previously. And that's largely due to raw material inflation continuing to increase. We're actually seeing some stabilization in some of the logistics and sea freight, so encouraging sign there.
Operator:
Our next question comes from Matthew Mishan from KeyBanc.
Matthew Mishan:
Excellent. I got 2 just to shake it up a little bit off of UroLift. First, just what snaps back in Interventional for the second half to get you to double digit -- high single-digit, double-digit growth for the year?
Liam Kelly:
Okay. So on Interventional, you are correct, it's an accelerating back half of the year. Obviously, one of the contributors to that is MANTA. As we said, we expect MANTA to grow in and around that 50% mark and will drive a significant proportion of the growth. We also have some supply chain disruption for some of our products in the second quarter that will flush out in the back half of the year. And the Langston product is returning to the market also in the back half of the year, which drives that acceleration. And there's a little bit of comp year-over-year that helps as well, Matt, but we're confident that Interventional access will get to high single digits, low double digits in the back half of the year from a revenue perspective.
Matthew Mishan:
Okay. Excellent. And then on free cash flow, Tom, you were walking through some of the moving pieces of the first half. And I think everyone has been talking about the higher working capital. As you think about the full year, how should we be thinking about full year expectations for free cash flow at this point?
Thomas Powell:
Well, for the full year, right now, cash flow from operations is in the $400 million to $450 million range, with CapEx in the $75 million to $80 million range. Some of the things that impacted the first quarter and first half will also play out in the full year as to why it isn't as strong as last year
Operator:
Our next question comes from Mike Polark from Wolfe Research.
Michael Polark:
Two quick follow-ups on UroLift and then one bigger-picture question, if I may. Just the recall, was it fully sorted exiting June? Or is there a tail to complete July, August? And then July, any -- will you hazard a comment on UroLift volume thus far in July? And then the broader question is just -- you made a comment or 2 about favorable benefit so far from certain pricing actions. Can you just remind us broadly across the portfolio what you're doing there, order of magnitude? What kind of benefit are you driving towards? And what's kind of the -- over what time horizon might those benefits start to manifest in the numbers?
Liam Kelly:
Okay. So I'll start with pricing. So when we laid out our plan, our pricing was going to be 50 basis points. We will be at least 50 basis points on the year. We're ahead of that target as we sit here today. The areas where we take price, our Surgical business is doing well. Our Vascular business has been performing well. And also, our Anesthesia business has been driving some of that pricing. On the -- regarding the recall, yes, the recall is fully behind us in the quarter. We took all of the reserves for the inventory we took back in quarter 2, and it's all reflected in our financial results already. Regarding your question on future UroLift growth, in the quarter and what's happening in July, I don't want to get specifically into July, but it is reflected in what I said. We're expecting sequential improvement in Q3 and then further sequential improvement in Q4. So that will give you -- that's the indication that we have right now.
Operator:
Our next question comes from Craig Bijou from BofA Securities.
Craig Bijou:
I have one on UroLift and then a follow-up on margins. So at the Analyst Day end of May, you guys seemed pretty confident. And I apologize for asking such a granular question, and Liam, I know you provided a little bit of detail on the monthly performance. But I mean how did June sequentially compare to May? It seems you guys felt pretty strong at the Analyst Day, and then there's a decent-sized miss here. And I understand you didn't get the expected revenue in June from UroLift. But I was hoping just to maybe understand a little bit about the sequential growth kind of within the quarter, if you would.
Liam Kelly:
No, absolutely. And just to level set, so we were off the quarter by around $14 million. And when we gave our guidance at the beginning of the year -- and you're right, we reaffirmed it at the Analyst Day in quarter 2. We did anticipate an improving environment from April to June. So April was slightly below our plan. May did improve despite cold cancellations within the month of May, but we did not see the expected improvement in June. June was not a good month for UroLift, to be fair. In actual fact, June was worse than either of the 2 months and decelerated. We did get a little bit of an impact from the recall, just sales time from the recall. But I think the more significant factors were the ones that I pointed to
Craig Bijou:
Great. And then just thinking about margins really on '23 or going forward. And I know you're not going to provide guidance, but given some of the pressures that are bringing down margins this year, the lower just nominal amount of UroLift revenue this year, how should we think about your ability to expand margins looking ahead into '23?
Liam Kelly:
So I might ask Tom to cover that. If you don't mind, Tom.
Thomas Powell:
Yes. Sure. So conceptually, as we think about moving forward, there are a couple of things that will drive margin in the future. One is clearly mix. And as we've spoken about, our high-growth portfolio of products also are higher-margin products. So as those continue to grow, they will provide a nice mix benefit as they represent a disproportionate amount of growth in the business. We -- and obviously, UroLift -- we need to get UroLift back and growing to help us achieve everything that we wanted to achieve at the Analyst Day guidance. I would say that as we look at some of the other drivers, we've got restructuring programs out there that, based on what we've currently announced and are active on, we've got about $45 million of savings left to be realized there. And then we also have a number of cost improvement initiatives that go on every year within the plants and distribution centers, et cetera, that drive meaningful amounts of productivity, a lot of Six Sigma type of work. So those are the key drivers for us. As we think about the guidance we have provided at the Analyst Day, we had assumed an inflationary environment continues throughout the LRP time frame. Although not quite to the same level of this year, we had assumed that there would be inflationary pressures going forward. And that's still our belief right now based on what we're seeing.
Operator:
Our next question comes from Richard Newitter from Truist.
Richard Newitter:
Just going back to UroLift for a minute. The -- I'm just curious. I totally appreciate that it's mostly the underlying environment, office visits aren't kind of back to where you needed them to be, staffing shortages, maybe a little bit of recall impact. But is there anything else that you guys are picking up in the field with respect to potential share shifting to other types of minimally invasive or even more invasive types of procedures? Is there anything going on there? And anything with respect to retreatment rates and changes in views on the way doctors are kind of doing even more traditional types of surgical approaches?
Liam Kelly:
Yes. So I'll start with retreatment rates. The Kaplan study, which was a 35,000-patient retrospective study clearly demonstrated that retreatment rates for UroLift were very similar to TURP and were well below the retreatment rates for other technologies that are out there in the marketplace. With regard to share shift, no, Rich, plain and honest answer, we haven't seen any share shift in the marketplace. We've analyzed our -- all of the accounts within -- that do business with UroLift and Teleflex, and we have not seen share shift within our existing accounts. We firmly believe that it is end market dynamics that are having the impact on UroLift and the postponable nature of the procedure. So yes, I think that would be the case.
Operator:
Our next question comes from Mike Matson from Needham.
Michael Matson:
So I have two questions. I'll just ask them both. So first on UroLift. I mean the DTC, I mean you're talking about these metrics and that you're running ahead of expectations and so forth. But I mean, I guess, I'm just wondering -- we're almost a year into this now. I mean what's happening with these patients? I mean shouldn't the ultimate measure or metric here be the procedure growth, I mean, which is negative? So are these patients just not scheduling with their urologists yet? Or are the urologists turning them down because they're too busy doing other procedures or something? And then my second question is not on UroLift but just on Vascular Access. You saw slower growth, and you called out some factors there that caused that. Just wondering if that would potentially continue beyond the second quarter.
Liam Kelly:
Yes, Mike. Thank you. So with regard to DTC, we're very pleased with the performance of DTC. At the half year stage, we're ahead of all of our metrics regarding patients that we're sending on to urologists through all the different media. We do know from our survey it is taking urologists much longer to schedule these patients. That time frame has elongated. But we see the role of DTC is to make men aware that UroLift exists and move those men on to the care of urologists so that the procedure can get done. You are correct, the ultimate measure should be the patient flow on volume. But unfortunately, in the current environment, patient flow into urologists is down. And also the capacity of urologists to do these procedures because of staffing shortages is also impacted. With regard to your question on Vascular Access. So Vascular Access grew 1% in the quarter. What we saw was fewer intensive care patient visits because of COVID. And this is one of the businesses that is seeing some supply chain disruption. So we've got a modestly heightened back order situation with our Vascular Access portfolio in the second quarter. We still expect it to grow mid-single digits for the full year, Mike.
Operator:
That is all the time that we have for questions this morning. I will hand it back to Lawrence Keusch for any final remarks.
Lawrence Keusch:
Thank you, Darius, and thank you to everyone that joined us on the call today. This concludes the Teleflex Incorporated Second Quarter 2022 Earnings Conference Call.
Operator:
Our conference call for today is now concluded. Thank you all for your participation. You may now disconnect.
Disclaimer*:
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Operator:
00:04 Good morning, ladies and gentlemen, and welcome to the Teleflex First Quarter 2022 Earnings Conference Call. At this time, all participants have been placed in listen-only mode. At the end of the company's prepared remarks, we will conduct a question-and-answer session. Please note that this conference call is being recorded and will be available on the company's website for replay shortly. 00:25 And now I will turn the call over to Ms. Lawrence Keusch, Vice President of Investor Relations and Strategy Development.
Lawrence Keusch:
00:32 Good morning, everyone and welcome to the Teleflex Incorporated first quarter 2022 earnings conference call. The press release and slides to accompany this call are available on our website at teleflex.com. As a reminder, this call will be available on our website, and a replay will be available. Please refer to our press release from this morning for details on how to access the replay. 00:59 Participating on today's call are Liam Kelly, Chairman, President and Chief Executive Officer and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks and then we'll open the call to Q&A. 01:16 Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. 01:40 The factors that could cause actual results or events to differ materially include, but are not limited to factors referenced in our press release today, as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. During this conference call, you will hear management make statements regarding intra-quarter business performance. Management is providing this commentary to provide the investment community with additional insights concerning trends and these disclosures may not occur in subsequent quarters. 02:17 With that said, I'll now turn the call over to Liam for his remarks.
Liam Kelly:
02:22 Thank you, Larry, and good morning, everyone. It's a pleasure to speak with you today. Teleflex continues to execute well despite a challenging environment. For the first quarter, Teleflex generated 3.2% constant currency revenue growth year-over-year. When adjusting for the estimated 1% impact of one less selling day in the quarter, compared to the prior year period and the impact of our 2021 respiratory business divestiture, the underlying growth in the quarter was 5.8% year-over-year, despite some disruption from COVID in January and early February. 03:02 Adjusted earnings per share increased 0.3% year-over-year to $2.88, reflecting growth in the business offset by the impact of incremental inflation and investments for our growth drivers. Once again, our steady performance in the quarter was driven by the company's balance of growth drivers, broad portfolio of medically necessary products and category leadership, offset by the impact of COVID-19 and the divestiture of the respiratory assets. 03:35 Although the surge in COVID infections disrupted the business during the first half of the quarter, we had a better-than-expected performance in March. Specifically, we saw a notable impact in January and early February, driven by deferrals of procedures, patient reluctance and patients and caregivers contracting COVID, which negatively impacted procedure volumes. However, as COVID infections declined, we saw a notable uptick in our business as we exited February. 04:08 In the quarter, our high growth portfolio, which accounted for approximately 25% of revenues in 2021 and includes UroLift, MANTA, hemostatic products, EZ-IO, OnControl and PICCs performed well. When excluding UroLift, which was anticipated to build momentum through the year, the remainder of products in the high growth portfolio increased in the low double-digits when adjusting for one less selling day in the quarter. 04:37 We continue to expect our high growth portfolio to grow in the mid-teens for 2022 as the environment normalizes and UroLift growth improves over first quarter levels. Our durable core remains on track for 4% growth in 2022 as assumed in our guidance. Overall, we are pleased with our first quarter performance, despite the COVID-related disruptions and year-over-year inflationary pressures from freight, raw materials and labor. I am also pleased to report that our pricing strategy has gained traction early in the year and I feel very confident in delivering our plan of 50 basis points and positive pricing in 2022. 05:24 We continue to assume a more normalized operating environment as we progress through 2022, due to a decrease in COVID disruptions and an increase in elective surgical procedures. Given that it is still early in the year, we are maintaining our constant currency and adjusted earnings per share guidance for 2022. 05:49 I would once again like to thank the entire Teleflex team. The resilience of the organization continues to hold fast. Although the disruptions from the pandemic have been longer than anticipated, I believe the Teleflex team is managing through this exceptionally well. The hard work and dedication of our employees continues to be felt throughout the organization and with our customers, patients and in our communities. 06:18 With that, let's turn to a deeper look at our first quarter revenue results. I will begin with a review of our reportable segment revenues for the first quarter. All growth rates that are referred to are on a constant currency basis unless otherwise noted. During the first quarter, our Americas, EMEA, Asia and OEM segments demonstrated resilience with all regions showing constant currency revenue growth year-over-year. Again, we continue to see the benefits of our diversified product portfolio in this challenging environment. 06:59 Americas revenues were $378 million, which represents 0.8% growth year-over-year. In the quarter, surgical was the biggest contributor to growth, partially offset by the impact of COVID-19 and one less selling day. Excluding the impact of the selling day, the Americas region grew approximately 2.3% year-over-year. The headwind associated with the respiratory divestiture to the Americas growth was minimal in the quarter. 07:31 EMEA revenues of $136.9 million increased 3.4% year-over-year with Interventional, Vascular Access, and Anesthesia products leading the growth. EMEA continues to face a headwind from COVID-19 in early January and subsequently saw procedure volumes improve as countries across the region continued to open up. Excluding the impact of the respiratory divestiture, revenues rose 7% year-over-year. 08:07 Turning to Asia. Revenues were $69.2 million, increasing 12.5% year-over-year. China revenues increased at a strong double-digit rate, led by growth in Vascular and Surgical. While Southeast Asia and Japan also contributed to the performance in the quarter. Excluding the impact of the respiratory divestiture, Asia revenues rose 18.5% year-over-year. 08:36 Let's now move to a discussion on our first quarter revenues by global product category. Consistent with my prior comments regarding our reportable segments, commentary on global product category growth for the first quarter will also be on a constant currency basis and ranked by size of our business units. Starting with Vascular Access, revenue increased 3.2% to $166.1 million. Our category leadership in central venous catheters and mid lines along with our novel coated PICC portfolio continues to position us for dependable growth. PICC growth was in line with internal expectations for the quarter. We expect PICCs to grow faster than the market with double-digit growth for 2022 as we invest behind our differentiated portfolio. 09:33 Moving to Interventional, revenue was $96.9 million, up 2.3% year-over-year. We executed well during the quarter with growth across our broad portfolio. We continue to invest behind our interventional portfolio, including complex catheters and MANTA, our large bore closure device. MANTA revenues were as expected in the quarter with usage continuing to expand both in the U.S. and in international markets. In turn, we remain on track for our 2022 revenue objectives. 10:11 Now to Anesthesia, revenue was $86.9 million, up 5% year-over-year. LMA single use masks and aesthetic products, atomization and airway all contributed to growth in the first quarter, partly offset by lower sales of tracheostomy products. Hemostatic products revenues were in line with our expectation for the quarter. 10:36 In our Surgical business, revenue was $89.7 million, representing 14.4% growth year-over-year. Among our largest product categories, we continue to witness robust growth in sales of metal and polymer ligation clips offset by timing of orders in our instrument business. For Interventional Urology, revenue was $74.9 million, representing an increase of 2.2% year-over-year and slightly above our internal expectations. 11:09 As expected, the performance in the quarter was negatively impacted by the meaningful acceleration in COVID cases in January and February which not only impacted patients, but also resulted in staffing shortages. However, we saw improvements in the operating environment sequentially as COVID-related disruptions began to ease. 11:33 OEM revenues increased 9.2% year-over-year to $57.7 million. Once again, our order book remains strong as customers recognize our broad competencies. We remain well positioned with competitive capabilities across our markets, including faster growth opportunities in fin mold, advanced interventional microcatheters used in neurovascular and other applications. 12:00 And finally, our other category, which incorporates sales of respiratory products not included in the divestiture to Medline, urology care and manufacturing and supply transition agreement revenues related to our respiratory business divestiture declined by 11.7% to $69.5 million year-over-year. The decline reflects the loss of revenue, due to the divestiture of the respiratory products, partially offset by manufacturing and supply transition agreement revenues. 12:32 We continue to expect manufacturing and supply transition agreement revenues to partially offset the impact on our revenue growth related to the divested respiratory assets over the first half of 2022 and that all MSA revenues was phased out at the end of 2023. That completes my comments on the first quarter revenue performance. 12:56 Turning to some commercial updates and starting with UroLift. We continue to see UroLift positioned for accelerating growth in the second half of 2022 as pandemic headwinds abate through the year and as elective surgical procedures become less disruptive. Accordingly, there is no change to our 15% year-over-year growth outlook for the year. 13:19 UroLift remains differentiated from other outpatient BPH treatments with strong clinical results, studies showing rapid symptom relief and recovery, no new sustained sexual dysfunction and durable results. Investors familiar with Teleflex will be aware that UroLift is being positioned for patients that are suffering from BPH and have failed or are not satisfied with drug therapy. Our DTC program remains an important element in our market building activities and is poised for another successful year with internal metrics tracking to or above plan in the first quarter. 14:02 As discussed previously, we are laser focused on improving UroLift utilization for existing users and driving increased productivity of the roughly 900 surgeons that were trained in the midst of the pandemic. Our sales force is fully engaged to advance the rollout of UroLift 2 with conversion of the vast majority of our U.S. users anticipated by the end of 2022. Importantly, we are getting very good feedback from surgeons that have now converted the new device. 14:37 In addition, UroLift 2 remains an important margin driver and we remain positioned to generate approximately 400 basis points of UroLift gross margin expansion once the U.S. user base is fully converted. We believe that a tactical approach to moving our existing UroLift users back towards pre-pandemic procedure level is the most effective way to improve growth in 2022. Even though it is early days, we are encouraged by the improvement we are seeing in the growth from existing UroLift users. 15:15 Now turning to an update on our international expansion strategy for UroLift. We have initiated our launch of UroLift in Japan on time and consistent with the April 1st implementation of reimbursement. We have now completed initial cases with key opinion leaders and we are methodically ramping up volumes. The feedback from the first cases has been overwhelmingly positive, which reflects the clinical benefits of the UroLift System and our field clinical capabilities. Although we consider 2022 as a building year for Japan, the contrary remains an important long-term opportunity for UroLift with a 2 billion TAM and we are excited to bring this clinical beneficial treatment to those suffering from BPH. We continue to expect our sales in the region to ramp in a similar fashion to the United States in a market that is one-third the size. 16:14 As we look into the second half of 2022, we expect revised reimbursement in France and we anticipate launch activities in select regions in Italy and Spain. We still expect to obtain clearance for UroLift in China in 2023. 16:30 Turning to the Vascular business, we recently received an award of a Sole Source Group Purchasing Agreement with Vizient for the supply of central venous access products. The Group purchasing agreement includes access to Teleflex's leading portfolio of CVCs with differentiated antimicrobial technology, as well as the recently launched ErgoPack complete system. The agreement goes into effect in August and should generate incremental revenue for Teleflex over the next several years. That said, the impact of the agreement was already contemplated in our annual guidance for 2022. 17:10 Regarding potential label expansion opportunities for the hemostatic product portfolio, as we indicated previously, we have completed patient enrollment in a 231 patient IDE study evaluating the performance of QuikClotControl+ Hemostatic devices from mild to moderate bleeding in cardiac procedures, as compared to standard gauze. We remain on track with our regulatory milestones and recently filed 510(K) for expanded use of QuikClotControl+. 17:44 That completes my prepared remarks. Now, I would like to turn the call over to Tom for a more detailed review of our first quarter financial results. Tom?
Thomas Powell:
17:55 Thanks, Liam, and good morning. Given the previous discussion of the company's revenue performance, I'll begin with margins. As anticipated, gross and operating margins declined year-over-year in the first quarter. For the first quarter, adjusted gross margin totaled 58.4%, 100 basis point decrease versus the prior year period. The year-over-year decrease was the result of incremental inflation in freight, raw materials and labor, partially offset by favorable pricing. 18:27 As expected, inflation was the largest contributor to the year-over-year decline in gross margin for the first quarter. As previously mentioned, our 2022 guidance contemplates a 70 basis point impact to gross margin from incremental inflation. 18:44 Adjusted operating margin was 25.7% in the first quarter, 180 basis point year-over-year decline as a result of the lower gross margin and planned investment in the business for our growth drivers, partially offset by disciplined expense management. 19:01 Net interest expense totaled $10.2 million in the first quarter, a decrease from $16.1 million in the prior year period. The year-over-year decrease in net interest expense reflects savings from the early redemption of the 2026 senior notes and the impact of reductions to outstanding debt using the proceeds of the respiratory divestiture and operating cash flows. 19:24 Our adjusted tax rate for the first quarter of 2022 was 11.9%, compared to 13.9% in the prior year period. The year-over-year decrease in our adjusted tax rate is primarily due to further enhancements in tax efficiencies of our global structure, partly offset by costs arising from the new provision of the U.S. tax law requiring the capitalization of certain R&D expenses. At the bottom line, first quarter adjusted earnings per share was $2.88, which was relatively flat year-over-year. 19:59 Turning to select balance sheet and cash flow highlights. Cash flow from operations in the first quarter was $62.1 million, compared to $110.8 million in the prior year period. The decline was primarily attributable to unfavorable changes in the working capital driven by higher bonus payments in the first quarter, due to improved performance in 2021 versus 2020. Also impacting cash flow was increase to our inventory levels provide support for future growth and to minimize potential impact from supply chain disruptions. 20:35 Moving to the balance sheet. Our financial position remains healthy. At the end of the first quarter, our cash balance was $466.7 million, as compared to $445.1 million at year-end 2021. Net leverage at quarter end was approximately 1.7 times, which remains well below our 4.5 times covenant. 20:57 Now moving on to our 2022 guidance. We are reaffirming our expectation for constant currency revenue growth of 4% to 5.5% in 2022. In addition, we still expect reported revenue growth of 2.3% to 3.8% in 2022, implying a dollar range of $2.874 billion to $2.917 billion. Excluding the year-over-year headwind in the respiratory divestiture, our underlying constant currency revenue growth is still expected to be 5.5% to 7%. 21:33 Moving to earnings, we are reaffirming our adjusted earnings per share guidance of $13.70 to $14.30 for 2022, a 2.8% to 7.3% year-over-year increase. Our guidance continues to include headwinds from the respiratory divestiture inflation that together represent roughly $0.50 in 2022. Earnings per share growth excluding the respiratory divestiture and the incremental inflation is expected to be approximately 7% to 11%. 22:06 And that concludes my prepared remarks. I would now like to turn it back to Liam for closing commentary.
Liam Kelly:
22:12 Thanks, Tom. In closing, I will highlight our three key takeaways from the first quarter and our 2022 outlook. First, our diversified product portfolio enables Teleflex to deliver constant currency growth of 3.2% in the first quarter, despite another wave of COVID. When adjusting for one less selling day and the headwind from the respiratory divestiture, the underlying business growth approached 6%. 22:41 Second, we will continue to effectively manage the business and look for ways to minimize incremental headwinds from inflation and supply chain challenges. Although foreign exchange remains out of our control, we remain confident in our ability to deliver against our 2022 financial guidance. 23:00 Third, we continue to execute against our long-range growth strategy. We will continue to incrementally impacting our high growth portfolio and drive dependable expansion in our durable core portfolio. We have levers in place to drive further expansion in our margins and our balance sheet is in a solid position with leverage at 1.7 times, providing ample financial flexibility for our capital allocation priorities including M&A. We remain confident in our future and our ability to continue to meet our commitments to patients, clinicians, communities and shareholders. 23:40 That concludes my prepared remarks. Now, I would like to turn the call back to the operator for Q&A.
Operator:
23:48 Thank you. [Operator Instructions] Our first question today comes from Jayson Bedford from Raymond James. Your line is open.
Jayson Bedford:
24:17 Hi, good morning, and thanks for taking the questions guys. Maybe just to start – hi, you reiterated the UroLift guide of 15% for the year. I'm just wondering has the cadence changed at all with respect to the gating in second quarter versus second half? And then just more broadly, I'm curious, in your view, what's the gating factor right now to broader use? Is COVID truly in the rear view mirror? Are you still having -- facing some staffing concerns that are -- that puts slowing growth?
Liam Kelly:
24:55 So, Jayson, thanks for the question. So first of all, I would say that we feel really confident in our full year UroLift guidance. I think the year is playing out pretty much as we expected year-to-date. January was impacted by COVID over the first two months -- or two weeks of February. But we still ended up with a positive growth slightly ahead of our expectations, due to the strength that we saw as we went into March. Nothing has changed in our outlook, Jayson. We still expect the first half of the year to be low-single digits and we expect to see an improvement in the second half culminating in the full-year growth of 15%. The acceleration in the second half is really due to the second part of your question. We will be out the other side of COVID, patient confidence we see recovering and we definitely see procedure volume start to come back into the fold. 25:53 During quarter one, I was out on the road and I met with 32 urologists, Jayson. And it's hard not to feel enthusiastic for the recovery in the back half of the year given what I heard from those urologists. They realized that urology procedures are beginning to come back. Patient confidence is beginning to come back. And so I think I'll finish by saying on your question by saying, yes, feel really good about 15% in the back half of the year. 26:22 And you know that if you go into Q3, Jayson, it's simply a question of math. If you remember Q2 last year, we did $94 million -- $92 million and Q3 last year was $83 million. So the majority of the growth just comes from run rate as you go from Q2 into Q3. And then you will see in the back half, I think Q4, you normally get an uptick in Q4. And as people use their deductibles that fuels that and you would also expect existing dock utilization to pick up as we see DTC start to flush through as well. So all of the metrics tell us the 15% is good, Jayson, and we feel really confident on it.
Jayson Bedford:
27:03 Okay. Very, very clear. Thanks, Liam. And just as a quick follow-up. It's obviously been a volatile market, both private and public here, less than 2 times levered of the stated intention to deploy capital. So my question is, has the environment impacted your capital allocation decisions at all?
Liam Kelly:
27:24 No the market has not. If anything I feel good, I feel a lot better than I did last year about the markets. You're right, our leverage is now low now to 1.7 times. So in order to do M&A, the most important thing you need is firepower. We are chasing assets, I can't tell you when we get efficient to both, but we've got a lot of -- got lines out there, with very attractive hooks on them. We will maintain our financial discipline, Jayson. And I think that the heady nature of the IPO market that we saw in 2021 has moderated. So therefore we think it's a good environment for Teleflex with the firepower we have to continue to do M&A. Obviously, we'll continue to fund R&D, we will continue to fund our restructuring programs as well, but our main focus right now is out there looking for a nice -- a good M&A opportunity, scale tuck-in, dealer to direct and also late-stage technologies.
Operator:
28:27 Our next question comes from Cecilia Furlong from Morgan Stanley. Please go ahead.
Cecilia Furlong:
28:33 Hey, good morning and thank you for taking the questions. Liam, I wanted to continue a bit just your near-term outlook as you think one about trying to impact on staffing shortages. If you could just talk about the puts and takes specifically for 2Q as we think about it, and also for UroLift, just the potential for staffing shortages to impact that market near-term and then looking beyond 2Q as well?
Liam Kelly:
29:01 Yes, I mean, I think the first thing Cecilia is that we reiterated our full-year guidance, so that will tell you the confidence level we have and the numbers we have out there. With regard to China, I'll start there and then I'll come to UroLift, but with regard to China, as we said in our prepared remarks, China produced really strong double-digit growth in Q1 with APAC growing 18.5% ex the respiratory divestiture, obviously lockdowns are in place in Shanghai and with some port closures. 29:33 We normally have a couple of months of inventory in the channel. So as long as the lockdowns do not become prolonged and widespread, I believe the situation is very manageable for Teleflex. And just to level set everybody, China is approximately 4% of our global revenues and we do not manufacture any products within China. 29:53 Regarding the UroLift question and staffing shortages, again when I met with those 32 urologists, two things really resonated with me from those conversations. Number one, they have all seen patients come in as a result of our DTC. So that's a real positive for us, it’s having an impact out there. And the other thing that I heard from them is yes, they were impacted and are currently being impacted by staffing shortages, but it is getting better. They are seeing an improving environment and then this was in February out in the road. So they were beginning to see an improving environment as they came out the back side of COVID and they felt confident that they would be able to address their staffing charges. 30:36 Much more acute in the office then in the ASC and the office was my observation in those conversations as well. So I still think there's going to be a little bit of a staffing issue as you get into Q2. I think if you get better as you go back to the back end of the year, which is actually quite good because I also anticipate patient confidence improving as you go through Q2, into Q3 and Q4.
Cecilia Furlong:
31:00 Thank you. And if I could follow-up as well on MANTA just off of the investment in the back half of last year. How are you thinking about growth to that profile of that business unit for 2022? And thank you.
Liam Kelly:
31:15 Thanks, Cecilia. As we've said, since the beginning of the year, we anticipate that MANTA will grow in excess of 50% for the year pretty much, due to that investment in acute focus on a greater adoption. We now believe we'll be able to train more docs and we also think that the international growth, in particular, in EMEA is going to be quite robust. So we still feel confident. And as I said in my prepared remarks, MANTA had a good solid first quarter even with the impact of COVID in January and early February.
Operator:
31:52 Our next question comes from Shagun Singh from RBC Capital Markets. Please go ahead.
Shagun Singh:
31:58 Thank you so much for taking the question. Liam and Tom, your guidance then reflects a wide range for EPS and is unchanged despite the Q1 beat. So can you just walk us through what the offsets are given the Q1 beat, what are you now assuming at the top versus the bottom end. And given the incremental headwinds from FX and inflation, are you more comfortable at the top or the bottom end? And then just as a follow-up, can you just talk about FX? I think the euro spot rate included in your initial guidance was for 1.12 and it seems to be tracking now at 1.05. So, by my math, that could be a meaningful headwind. So what are the offsets there? Thank you.
Thomas Powell:
32:42 Well, I would first of all say that with respect to the EPS, we're really pleased with the first quarter results despite the challenging environment from COVID, constant currency revenue growth was at 5.8% after adjusting for the sales of the respiratory assets in one less shipping day. Also say expenses were fairly well aligned with expectations. Now with that being said, foreign exchange and interest rates have been fairly volatile of late to your point. And as a result, we'd like to give ourselves another quarter to see how things are playing out before we would make any adjustment to earnings. 33:19 As we think about foreign exchange, we had given guidance at the beginning of the year and that was set when the euro was at $1.12. We had mentioned that at that point, it would be 170 basis point headwind to revenue and 20 basis point headwind to EPS. The rule of thumb that we've given in the past is as the euro moves and this obviously can be offset or somewhat offset or further impacted by other currencies as well, but the rule of thumb on the euro is that for every penny move, it's about $0.05 impact full-year to earnings. 34:00 Now given that we've already passed through one quarter, I'd say it's probably $0.035 to $0.04 per penny of euro. And again, this amount may be partially offset by some other currency moves throughout the world. But I'd say that as we think about the guidance that we just gave and reaffirmed, we're reflecting what we're seeing from an inflationary environment and that assumption is that the inflationary environment that we experienced in the first quarter of the year will largely remain throughout the balance of the year. And that's factored into our guidance.
Operator:
34:40 Our next question comes from Larry Biegelsen from Wells Fargo. Your line is open.
Larry Biegelsen:
34:46 Good morning, thanks for taking the question. Just one for me, Liam, you've got an Analyst Meeting coming up here next month. Just at a high level, any thoughts on how you're feeling about kind of the 6% to 7% LLP growth algorithm and street models right now are assuming about 100 basis points leverage per year after 2022. Any thoughts you can provide as we head into that meeting would be appreciated. Thanks so much.
Liam Kelly:
35:22 Yes, Larry, thank you very much for the question. Look, we're really looking forward to engaging with the investment community in late May. I think what we'll be communicating is durable sustainable top line growth. I don't want to really put a number on it right now, but if you wait for another few weeks, Larry, will be unveiling on that. We want to show margin expansion within Teleflex. We still have restructuring programs in place. We still have mix that's going to work in our favor. We will obviously have conversations on cash flow generation, capital deployment. Our main focus of capital deployment, as I said earlier, is M&A, R&D and part of the restructuring programs. 36:02 And obviously, you'll see us continue to focus on ESG. So I think those would be the broad themes that we'll be discussing with the investment community. And obviously we will invest behind our high growth portfolio and communicate on the expectations for that aspect of our business as well. I think that 25% of our portfolio is very exciting to us. UroLift is clearly included there, but there is a lot more to Teleflex than UroLift and we want the investment community to see that. 36:29 With MANTA is very exciting, our hemostatic portfolio is very exciting, our Intraosseous portfolio and our PICC portfolio, all had really solid growth drivers. And actually UroLift is in the middle of the pack from a margin perspective. So it is broad appeal to Teleflex and that's what we want to communicate also.
Larry Biegelsen:
36:47 All right. Thanks so much for taking the question.
Liam Kelly:
36:50 Thanks, Larry.
Operator:
36:52 We now turn to Matt O'Brien from Piper Sandler. Your line is open.
Unidentified Analyst:
36:58 Hi guys, good morning. This is Drew on for Matt and thanks for taking the questions. Maybe if you could just speak to the very near-term for UroLift, what do you actually see on the ground from a volume perspective. I think the Street's volume mid single-digit growth here in Q2. Is that consistent with what you're seeing right now? And then just -- are you seeing any meaningful transitions in site of care so far this year?
Liam Kelly:
37:26 Can you just repeat the last part of your question? Meaningful transitions --
Unidentified Analyst:
37:31 In site of care --
Liam Kelly:
37:33 Yes, thank you very much. So really what we saw with, as I said earlier, in my commentary, we still expect UroLift in the first half of the year to grow low single-digit growth and then to accelerate in the back half and we're very confident on the 15% for the full-year. And it's really playing out as we anticipate as a company. Obviously, Q1 was impacted by COVID in January and early February. We were encouraged by what we saw in March. March did show the green shoots of recovery. Also our strategy that we've implemented on focusing on existing users and training those 900 docs that were brought on during the pandemic is also showing some early green shoots and we're encouraged by what we're seeing there. 38:25 We're driving doc utilization on UL 2 and ATZ. And obviously our DTC campaign is adding to our confidence in the growth for UroLift. I'm really pleased to report that we have seen no shift in site of care and we do not anticipate seeing any shift in site of care. The vast majority of our office based urologists have signed up to our new pricing strategy and that is now implemented and being rolled out to its full. So no shift in site of care, don't expect any shift in site of care for the remainder of the year. And again I'll reiterate feel good about 15%.
Unidentified Analyst:
39:10 Okay, very helpful. And then just quick follow-up here on your commentary on the positive pricing, how do we think about those 50 bps of price -- positive price in comparison to the inflationary pressures you're seeing. And when -- based on what you think those inflationary pressures may subside, is there room to push that price even higher if those pressures are more persistent? Thank you.
Liam Kelly:
39:38 So my father used to say that a good start is half the battle. And we've had a good start to our pricing and the rollout of our pricing and I feel really encouraged by that. In regard to your question about how it impacts inflation, so we're expecting 50 basis points of positive pricing and we're expecting 70 basis points of inflation and it's already baked in to our forecast. I think that there is -- Teleflex has always been a company that's been able to deliver positive pricing. And I think if inflation gets worse, I do believe that there is some flexibility for us to increase our pricing in the future.
Operator:
40:22 We move on to Matthew Mishan from KeyBanc. Please go ahead.
Matthew Mishan:
40:28 Good morning and thanks for your questions. Liam, could you talk to us some of the dynamics of the Interventional segment and how we should be thinking about growth in that segment for 2022?
Liam Kelly:
40:41 Absolutely, Matt, thanks for the question. So as we look, nothing has changed from our guidance at the beginning of the year. We still expect our Interventional portfolio to grow high single-digits, low double-digits with good execution. I think that the quarter, the first quarter came in right as we expected it. We had some impact as one would expect from COVID in January and early February, but the recovery looks quite encouraging for interventional access. 41:15 Just on a broader comment, I think hospitals are probably managing the recovery out of the other side of COVID probably better than ASCs and offices. And that's what we're seeing across the board. So feel really good about the trajectory of that business and feel really good about the trajectory of MANTA and the rest of the portfolio. So high-single, low-double digits with good execution matters is what I would expect for the year.
Matthew Mishan:
41:39 Okay. Excellent. And then on Anesthesia, can you talk about Z-Medica versus the broader Anesthesia portfolio and how that did in the quarter?
Liam Kelly:
41:49 Yes, I just said in our prepared remarks, Z-Medica was right in line with our expectation. We still expect the Z-Medica portfolio, the hemostatic portfolio to grow high-single low double-digit with good execution. So very encouraged again by how that hemostaticportfolio is generating. And you could see it in the numbers, Matt. It's been a while since the Anesthesia portfolio has put up a 5% growth number as an organic growth number. So I think we're quite encouraged by that performance in the first quarter.
Operator:
42:37 Our next question comes from Richard Newitter from Truist. Please go ahead.
Richard Newitter:
42:43 Excuse me. Hi, thanks for taking the questions.
Liam Kelly:
42:46 Welcome back, Rich.
Richard Newitter:
42:48 Yes, I know, thank you. Thank you. It's great to be back. Thank you very much, Liam. Maybe just to start on UroLift, just this is such a strange year from a growth rate standpoint. Obviously, growth is being understated in the first half due to comps and COVID and in the back half, as you pointed out, from a math standpoint, it's the same thing to get your guidance for 15% [Technical Difficulty] well over 20%. So I appreciate the 15% is the growth in the growth rate outlook for this year. But Liam, can you just maybe help us think through what the right normalized growth rate is once we have kind of come out on the other side of recovery and anniversaried hopefully all of these different variables? Is 15% the right way to think about the U.S. UroLift business for now?
Liam Kelly:
43:41 So the way I look at it Rich is, we're very confident on growing at 15% this year. And this year it's all about the U.S. You will get a small contribution for overseas with Japan will ramp a little bit this year. You'll see France in the back half of the year a little bit from Brazil, Italy and Spain. And then you'll see China get the registration next year and we'll go into that market. And the way I look at it is we'll finish this year. We believe we'll get 15% growth, hopefully we'll be inside of COVID and it will be in the rearview mirror. You head into the following year, you'll have an easier comp in the U.S. in the first year and then you should see some contributions begin to ramp up in the international markets. 44:27 And Rich, it's great to have you back, but if you would just be a little patient for another couple of weeks and I'll tell you what UroLift is going to do over the next three years at the Analyst Day when we all get together in New York.
Richard Newitter:
44:42 Excellent. Looking forward to that, Liam. And maybe just one more follow-up. I might have missed it earlier, but your surgical performance this quarter, it came in well above our thinking, right? Just what was driving that again and 14% constant currency rate? Is that sustainable or was there something in there that we should be thinking about? And if you could also just comment on 2Q? Any guidance or color you can give to speed for modeling in the quarter ahead on revenue and earnings? Thanks, Liam.
Liam Kelly:
45:16 Yes, we began the year, Rich, by expecting our Surgical business to be low-single digit growth. The first quarter came out little bit ahead of our expectations and it was really driven by strong growth in APAC and the U.S. as procedures continue to recover. And also we saw some pricing benefit. This is one of the areas we always start to take pricing. We still expect lower single digits in the full-year, but maybe a good execution and again back to my earlier comment on pricing, if we can sustain it little bit better for the remainder of the year, we may get to the mid single-digits with good execution in our Surgical business which would be a really good performance for that business overall. 45:56 So, again a good start as half the battle, as my father says, and Surgical definitely had a good start, but we still expect low singles maybe get to mid with good execution as we go through the year. And on the full-year basis, again as I said earlier, we feel really good about our -- the broad-based recovery and we feel really good about our full-year guidance and Surgical is no different than the total of Teleflex.
Operator:
46:24 Our next question comes from Mike Matson from Needham and Company. Your line is open.
Mike Matson:
46:30 Yes, thanks for taking my questions. I guess I'll ask another one on UroLift. So you've ramped up the DTC advertising. It seems like there is a little bit of a conundrum here, because that the timing of when -- I think of when you kind of ramp that up was coincided with a lot of these COVID impacts and a slowdown in the growth. And I understand what's happening there and the sensitivity to the infection rates and whatnot. But I guess what gives you confidence that the DTC ads are actually proving effective and you're getting adequate return on the investment?
Liam Kelly:
47:09 Well, obviously we measure the effectiveness of our DTC campaign. At the end of last year, we know that the -- our expectation at the beginning of the year was to get 150% the number of impressions. We actually ended up at almost 200% right across all of the metrics, we look at the number of impressions, we look at the response from the patients, we measure the total estimated appointments and procedures. And we know based on all of that, Mike, that this is a good return on our investment. 47:42 Anecdotally, when I was out with those 32 urologists in the first quarter, everyone of them had mentioned that patients had come in and ask them about UroLift as a direct result of the DTC campaign. So anecdotally and measurably, we know that it is working. And we are seeing -- and we do see the value of priming the pump in order to put patients in the care of urologists. In all transparency, Mike, we don't care when the procedure gets done. As long as we are pushing these patients to our urologist and the vast majority of urologist that are champions, only offer UroLift. So therefore it's very focused. That's the one thing I will say about our DTC, it is very focused on docs put patients arriving with doctors that use UroLift almost exclusively.
Mike Matson:
48:41 Okay, got it. And then just wanted to ask about consensus for the second quarter, I didn't really hear any kind of commentary around where we should be modeling. I think -- I know you don't give any kind of quarterly guidance, but you do have a bit of a tougher comp for the second quarter. Are you okay with top and bottom line consensus estimates for that -- for the second quarter?
Liam Kelly:
49:02 Yes, you're right, Mike. We don't give quarterly guidance, but we have reaffirmed our yearly guidance. And I guess I'll leave it at that, that's -- we feel really confident on our yearly guidance on all lines.
Operator:
49:19 That's all the time we have for questions this morning. I'll now hand back to Mr. Lawrence Keusch for closing remarks.
Lawrence Keusch:
49:26 Thank you, Elliot. And thank you to everyone that joined us on the call this morning. This concludes the Teleflex Incorporated first quarter 2022 earnings conference call.
Operator:
49:39 Our conference call for today is now concluded. Thank you all for your participation.
Operator:
Good morning, ladies and gentlemen and welcome to the Teleflex Fourth Quarter of 2021 Earnings Conference Call. At this time, all participants have been placed in a listen-only mode. At the end of the Company's prepared remarks, we will conduct a question-and-answer session. Please note that this conference call is being recorded and will be available on the Company's website for replay shortly. And now I would like to turn the call over to Mr. Lawrence Keusch, Vice President of Investor Relations and Strategy Development.
Lawrence Keusch:
Good morning, everyone and welcome to the Teleflex Incorporated fourth quarter 2021 earnings conference call. The press release and slides to accompany this call are available on our website at teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing 800-585-8367 or for international calls, 416-621-4642 using passcode 1028958. Participating on today's call are Liam Kelly, Chairman, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks and then we will open the call to Q&A. Before we begin, I would like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include but are not limited to, factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K which can be accessed on our website. During this conference call, you will hear management make statements regarding intra-quarter business performance. Management is providing this commentary to provide the investment community with additional insights concerning trends and these disclosures may not occur in subsequent quarters. With that said, I will now turn the call over to Liam for his remarks.
Liam Kelly:
Thank you, Larry and good morning, everyone. It's a real pleasure to speak with you today. For the fourth quarter, Teleflex generated 7.9% constant currency revenue growth year-over-year and increased 10.4% over the comparable period in 2019. In the quarter, there was one extra shipping day which added approximately 1% to the year-over-year growth rate. Adjusted earnings per share rose 10.8% year-over-year. Our fourth quarter performance was driven by the company's balance of growth drivers, broad portfolio of medically necessary products and categories leadership, offset by the impact of COVID-19 and the divestiture of the respiratory assets. As we had anticipated at the time of our third quarter earnings report, COVID-19 remained a headwind during the fourth quarter and elective surgical procedures did not return to comparable 2019 levels. Specifically, COVID cases increased significantly during December in geographies with large populations, including the Northeast, Florida, Texas and California, as COVID spread quickly through these regions. We also saw increased staffing charges as COVID infections accelerated quickly in the latter portion of the quarter. Teleflex executed well in the quarter with dependable service levels to our customers while managing supply chain challenges, freight logistic delays and responding when COVID infection rates began to accelerate. Of note, when excluding UroLift which is the product that was most impacted by the pandemic, revenues from the remaining business grew over 9% on a constant currency basis in the fourth quarter year-over-year. Turning to our performance in 2021. Although the year presented challenges, I am proud to say that Teleflex executed very well. We confronted the unprecedented market disruption head-on as the pandemic continued to ebb and flow. We remain diligent and flexible in order to support our customer needs and keep our workforce safe. We responded effectively as freight and raw material supply challenges escalated through the year. Throughout the year, we stayed true to our objectives by advancing our strategy of driving durable growth, expanding margins and remaining good stewards of our balance sheet. During the year, we invested in our growth drivers, executed on our overseas strategy and rolled out new products. Our customers remained our focus and Teleflex team members enabled us to supply customers with products necessary to care for their patients. We continue to optimize our portfolio with the integration of HPC and Z-Medica acquisitions and we divested certain low growth and low margin respiratory assets. And we did not take our eyes of our people as we fortified our culture and advanced our ESG initiatives. From a financial perspective, we delivered on our full year 2021 financial commitments with constant currency sales growth of 8.8%, adjusted operating margin expansion of 310 basis points and adjusted earnings per share of $13.33, a 24.9% increase year-over-year. None of this would be possible if it were not for the tireless efforts of the global Teleflex team. I would like to thank our employees for their hard work and dedication during 2021 and throughout the pandemic. Turning now to a deeper look at our fourth quarter revenue results. I will begin with a review of our reportable segment revenues. All growth rates that I refer to are on a constant currency basis unless otherwise noted. During the fourth quarter, our Americas, EMEA, Asia and OEM segments demonstrated resilience with all regions showing constant currency revenue growth over 2020 when excluding the impact of the extra shipping day despite the continued headwinds from COVID. As I mentioned earlier, this underscores the benefits of our diversified product portfolio. Americas revenue was $451.7 million in the fourth quarter which represents 7.6% year-over-year growth. Contributors to the year-over-year growth were Surgical, Vascular and Interventional, partially offset by the impact of COVID-19. EMEA revenues of $164.5 million increased 4.8% year-over-year with Interventional, Surgical and Vascular Access products leading the growth. EMEA continues to face a headwind from COVID-19. Although procedure volumes improved year-over-year as countries across the region continued to open up. Excluding the impact of the respiratory divestiture, revenues rose 8.7%. Turning to Asia; revenues were $78.5 million, increasing 0.5% year-over-year. Excluding the impact of the respiratory divestiture, revenues rose 6.7%. Let's now move to a discussion of our fourth quarter revenues by global product category. Consistent with my prior comments regarding our reportable segments, commentary on global product category growth will also be on a constant currency basis and ranked by size of our business units. Starting with Vascular Access; fourth quarter revenue increased 6.4% to $193 million. Our category leadership in central venous catheters and midlines, along with our novel coated PICC portfolio continued to position us for dependable growth. The PICC portfolio continues to perform well with 11% growth year-over-year as we continue to invest behind our differentiated portfolio and are gaining market share. Intraosseous continues to be a dependable growth driver, with fourth quarter revenues rising approximately 17% year-over-year. Moving to Interventional; fourth quarter revenue was $114.9 million, up 8.2% year-over-year. We executed well during the quarter and saw a strong demand for our complex catheters and balloon pumps. We continue to invest behind our interventional portfolio, including complex catheters and MANTA, our large foreclosure device. MANTA momentum remains strong, both in the U.S. and in international markets, with growth of approximately 45% year-over-year. Of note, we exceeded our objective for 8% share in 2021 of the $200 million to $300 million global market opportunity. Turning to Anesthesia and Emergency Medicine; fourth quarter revenue was $102.8 million, up 20.5% year-over-year. Hemostat products drove the growth in the quarter, offset by tough comparisons in the airway business and lower sales of tracheostomy products. For the full year, Hemostat revenues were approximately $66.5 million and fell squarely into the $60 million to $70 million range that we had established coming into 2021. In our Surgical business, revenue was $106.4 million in the fourth quarter, representing 16.1% growth year-over-year. Among our largest product categories, we continue to witness robust growth in sales of our instruments and ligation clips as the elective surgical procedure environment was stronger than in the prior year period and hospital capital spending increased. For Interventional Urology; fourth quarter revenue was $92.9 million, representing a decrease of 1% year-over-year and a 12% increase sequentially. This result was above the $85 million to $91 million implied guidance for the quarter. We saw a clear improvement in UroLift procedure trends during October and November when compared to the third quarter. However, December was negatively impacted year-over-year by the surge in COVID-19 with continued staffing shortages and an increase in procedure cancellations. Of note, we did not see any pull forward of UroLift procedures into the fourth quarter of 2021 from 2022, resulting from the announcement of the Medicare physician fee schedule final rule in November. OEM revenues increased 3.9% year-over-year to $67.2 million in the fourth quarter as customer demand remains strong across our portfolio. We remain well positioned with broad capabilities in our markets, including faster growth opportunities in thin walls, advanced interventional microcatheters used in neurovascular and other applications. And finally, our other category which incorporates sales of respiratory products not included in the divestiture to Medline, Urology Care and manufacturing and supply transition agreement revenues declined by 12.2% to $84.7 million year-over-year. The decline reflects the loss of revenues due to the divestiture of the respiratory products, partially offset by manufacturing and supply transition agreement revenues and growth in Urology Care. We continue to expect manufacturing and supply transition agreement revenues to phase out at the end of 2023. That completes my comments on fourth quarter revenue performance. Turning now to some commercial updates and starting with UroLift. As we reflect on 2021, we continue to see COVID-19 as being the most disruptive force on the Interventional Urology business. Given the deferrable nature of BPH treatments, patient willingness can modulate depending on the severity of the pandemic. Our experience has shown that when COVID infections pick up, UroLift procedures are negatively impacted. And then recover when COVID case counts drop. In addition, staffing charges which we identified in the second quarter created business disruptions, particularly in our office site of service. Importantly, our analysis continues to confirm that we have not lost share completing device-based treatment for BPH. For 2021, UroLift revenues increased 18% year-over-year despite the broader category for urology procedures remaining below pre-pandemic levels. We continue to see UroLift positioned for accelerating growth as pandemic headwinds abate. COVID has remained a headwind early in the first quarter but we anticipate improvement in sales trends throughout the year as elective surgical procedures become less disrupted. UroLift remains differentiated from other outpatient BPH treatments with strong clinical results, studies showing rapid symptom relief and recovery, no new sustained sexual dysfunction and durable results. Investors familiar with Teleflex will be aware that UroLift is being positioned for patients that are suffering with BPH and have failed or are not satisfied with drug therapy. In 2022, we will be intentionally laser-focused on improving utilization of existing UroLift users and driving increased productivity of surgeons that were trained in the midst of the pandemic. We will also fully engage our sales organization to advance the rollout of UroLift 2 with conversion of the vast majority of the U.S. users anticipated by the end of 2022. UroLift 2 remains an important margin driver and we remain positioned to generate 400 basis points of UroLift gross margin expansion once the U.S. user base is fully converted. We believe that a tactical approach to moving our existing UroLift users back towards pre-pandemic procedure levels is the most efficient way to improve growth in 2022. As for our consumer marketing efforts, we continue to view direct-to-consumer as a multiyear catalyst for UroLift in the U.S. For 2021, we exceeded all of our internal targets for the DTC campaign and I would like to share a couple of highlights. Impressions increased nearly 200% year-over-year and exceeded our 150% objective. Likewise, UroLift brand awareness increased 60% year-over-year to 16% and has surpassed 14% per TARP which declined 600 basis points in 2021. Importantly, our DTC programs are extremely focused on driving revenue for Teleflex. Since the vast majority of our customers only offer UroLift for minimally invasive treatment of BPH. We will continue to fund our DTC campaign in 2022 and retain our flexibility to flex up and down depending on the macro environment. Additionally, our international market expansion remains active with several milestones expected for 2022. In Japan, we continue to make progress towards an upcoming commercial launch for UroLift. We secured reimbursement for UroLift last December and have a team in place to initiate our rollout launch once the reimbursement is implemented on April 1 of this year. Japan remains an important long-term opportunity for UroLift with a $2 billion TAM and we are excited for the upcoming launch. We continue to expect our sales in the region to ramp in a similar fashion to the U.S. in a market that is 1/3 the size. Now, turning to Brazil. We are encouraged by our initial commercial activity with a focus on training surgeons and securing reimbursement in the coming years. Additional UroLift launches could come in the second half of 2022, including France and initial activities in Italy and Spain. Finally, we remain on track for a regulatory clearance in China in 2023. To round out the update on UroLift, President Biden signed into law, the protecting Medicare and American farmers from Sequester Cuts Act on December 10, 2021. Among a number of important items, the law increased conversion factor in the Medicare physician fee schedule by 3% for 2022 versus the final rule issued in November. For UroLift specifically, the change will translate into an incremental $100 to $150 in profitability in the office setting in 2022 as compared to the MPFS final rule. We are encouraged by the improvement in reimbursement and will continue to work with stakeholders to address the unintended consequence of the changes to physician fee schedule that will limit choice for Medicare recipients and move procedures to higher-cost sites of service. Moving to some updates in our Interventional business unit. We have completed the sales force expansion which is intended to provide additional resources for MANTA training and increase our market penetration. On the clinical front, we recently received 510(k) clearance to extend the indication for our specialty support catheters, guide extension catheters and specialty guidewires to include cross chronic total occlusion. Our FDA filing was based on successful results from a peer-reviewed perspective single-arm IDE study that enrolled 150 patients across 13 investigational centers in the United States. The study met the protocol's primary endpoint of procedural success. And achieved technical success which is defined as successful guidewire recanalization in more than 93% of these very complicated CTO cases. We view complex PCI and especially CTO-PCI, as high-growth spaces within interventional cardiology. And our new labeled indication keeps us competitively positioned. Lastly, we continue to innovate around the core MANTA platform and initiated a limited market release of the 14 French branch depth locator during the quarter. The depth locator expands the use of the 14 French manteclosure for Impella in emergent cardiogenic shock procedures. Regarding EZPlas, we have not yet received U.S. regulatory clearance following the receipt of a completed response letter. Importantly, we do not have to collect additional clinical data and we have clear line of sight on the additional information that FDA is requesting. We remain committed to gaining FDA clearance for this novel and innovative product and will work collaboratively with the agency. We will update the investment community when we have additional information to share. Now, turning to our 2022 outlook. Teleflex remains well positioned to drive growth in these challenging times. Although the pandemic and it's effect on the health care providers are still with us, we expect the impact to be lower in 2022 versus 2021. We believe that elective surgical procedures should improve in 2022 over 2021. We are seeing excellent progress in the ability of the global health care systems to adapt to the pandemic environment. With each subsequent surge in COVID infections, hospitals continue to improve their ability to treat COVID-19 patients and perform elective surgical procedures. We also expect more people to become fully vaccinated and increasing availability of therapies to treat the virus after infection. Our range of guidance contemplates varying scenarios for the impact of COVID which depending on the level of disruption, inform our view on the top and bottom end of our outlook. In addition, our 2022 guidance assumes a normalization in our operating expense as the impact of the pandemic wanes. We will fund our commercial organization to remain in front of our customers and maintain investment for our growth drivers. It is important that we manage Teleflex for long-term durable growth and we will continue to fund our investments to keep us well positioned. That said, to the extent that COVID is more disruptive to revenues than we have assumed, we will be in a position to modulate our spending while still funding projects for long-term growth. Taking these elements together, we would expect to deliver underlying constant currency growth in 2022 that captures our prior 2019 to 2021 LRP growth algorithm of 6% to 7% when adjusting for the 1.6% headwind from the divestiture of the respiratory assets. We have made substantial progress over the past several years in reshaping the Teleflex portfolio by investing behind growth drivers and divesting slower growth respiratory assets. As we look forward, when excluding UroLift and our other business, the remaining 3/4 of our business is positioned to grow 4% to 5%. The growth is propelled by a base of medically necessary products and our high-growth portfolio of products, including MANTA, Hemostats, Intraosseous and PICC. On top of these revenues, UroLift remains a significant opportunity as pandemic-related disruptions recede in the United States and we execute on our multiyear multi-geography overseas expansion. We will also continue to execute on our M&A strategy to layer in additional growth drivers. That completes my prepared remarks. Now, I'd like to turn the call over to Tom for a more detailed review of our fourth quarter financial results. Tom?
Thomas Powell:
Thanks, Liam and good morning. Given the previous discussion of the company's revenue performance, I'll begin with margins. Gross and operating margins remained strong in the fourth quarter and exceeded levels achieved in the 2020 comparable period. Our continued progress in margin expansion in 2021 has allowed us to increase investments toward growth drivers which is an important component of our long-term strategy to enhance durable growth. For the quarter, adjusted gross margin totaled 58.8%, an 80 basis point increase versus the prior year period. The year-over-year increase in gross margin was driven by product and regional mix, restructuring benefits, operational efficiency programs, favorable impacts from pricing, M&A and foreign exchange, partly offset by inflation in freight, raw materials and labor. Fourth quarter adjusted operating margin was 27.6% or a 100 basis point year-over-year increase, driven by the gross margin improvement as well as disciplined expense management and partially offset by planned investment in the business and a partial normalization of expenses following deep reductions in discretionary spending during the prior year as a result of the COVID pandemics. Net interest expense totaled $11.8 million in the fourth quarter, a decrease from $18.5 million in the prior year period. The year-over-year decrease in net interest reflects savings from the early redemption of the 2026 senior notes and the impact of reductions of outstanding debt using the proceeds of the respiratory divestiture and operating cash flows. Our adjusted tax rate for the fourth quarter of 2021 was 13.8% compared to 10.1% in the prior year period. The year-over-year increase in our adjusted tax rate is primarily due to a lower benefit from stock-based compensation as compared to the prior year period. At the bottom line, fourth quarter adjusted earnings per share increased 10.8% to $3.60 and exceeded our internal expectations. Turning to select balance sheet and cash flow highlights. Cash flow from operations for 2021 totaled $652.1 million compared to $437.1 million in 2020. This represents a year-over-year increase of roughly $215 million. The increase was primarily attributable to favorable operating results, lower contingent consideration payments and proceeds received from the respiratory business divestiture that were attributed to performance obligations under the manufacturing and supply transition agreement. Moving to the balance sheet. Our financial position remains sound. At the end of the fourth quarter 2021, our cash balance was $445.1 million versus $375.9 million at the end of the fourth quarter of 2020. During the fourth quarter, we repaid $200.5 million of revolving credit facility borrowings. And at the end of the fourth quarter, $141 million was outstanding on our revolver. Net leverage at quarter end was approximately 1.7x which remains well below our 4.5x covenant. Lastly, we have no debt maturities of material size in 2022 or 2023. Now moving on to our 2022 guidance. To begin, I'll provide a framework of key planning assumptions underpinning our financial guidance. Although hard to predict in the current environment, our outlook for 2022 assumes that elective surgical procedures improve over 2021 but reflects COVID disruption in the first quarter. We also expect inflation to be greater in 2022 than 2021 with a larger impact in the first half of the year as compared to the second half. Our 2022 guidance ranges account for uncertainty on the severity of COVID. The impact of staffing shortage and inflationary pressures. The high end of the range assumes less impact from these factors but not a totally normal environment. In addition, our planning assumptions exclude any material regulatory or healthcare reforms as well as any future M&A that has not been disclosed. Now for the key elements of our 2022 guidance, starting with revenue. We remain confident in our portfolio of high-growth drivers and the durable growth core. We are taking a metered approach to begin the year, given expected near-term pressure from the recent COVID surge. We expect constant currency revenue growth of 4% to 5.5% in 2022. Excluding a 1.6% headwind from the sale of the respiratory assets last year, our constant currency revenue growth is expected to be 5.6% and 7.1% and captures our prior growth algorithm in the 2019 to 2021 LRP. Our high-growth portfolio which is spread across several business units and includes UroLift, MANTA, Hemostats, EZ-IO, OnControl and PICCs, represents approximately 25% of total revenues in 2021. As implied by our 2022 constant currency revenue guidance, our high-growth portfolio is expected to increase in the mid-teens with UroLift growth of approximately 15%. Our durable core platforms which account for over 60% of revenues are estimated to increase approximately 4%. Our other category includes sales of respiratory products not included in the divestiture to Medline. Manufacturing supply transition agreement revenues and Urology Care. It accounted for approximately 12% of total revenues in 2021. For 2022, this segment is anticipated to decline in the low to mid-teens year-over-year largely due to the respiratory divestiture. Now turning to currency. We expect foreign exchange rates will be a headwind to revenue growth of approximately 1.7%. As a result, we expect our reported revenue growth to be 2.3% to 3.8% year-over-year, implying a dollar range of $2.874 billion to $2.917 billion. Moving to gross margin. We anticipate that adjusted gross margin will be in a range of 59.75% to 60.25%. We continue to benefit from mix shift towards higher-margin products, restructuring and operational efficiencies, partly offset by incremental inflation. The incremental inflation is estimated to be a headwind of approximately 70 basis points in 2022, due primarily to elevated freight costs, raw materials and direct labor. Our guidance assumes that the elevated freight costs will show improvement in the second half of the year. Regarding operating margin, we expect adjusted operating margin to be in the range of 27.75% to 28.25%. Our 2022 guidance assumes incremental investments to support our key growth drivers, including UroLift, MANTA, intraosseous in the Asia Pacific region. In addition, as we have previously indicated, we continue to expect a normalization of operating expenses as COVID disruptions abate. Keep in mind that discretionary operating expenses, including T&E and open headcount were significantly curtailed in 2020 due to the impact of the pandemic on revenues and commercial activities. Although operating expenses increased in 2021, they were not yet fully restored to pre-COVID levels. As we plan for an improving environment in 2022, we are assuming a normalization of our operating expenses as well as investments for our growth drivers. Despite the disruptions over the past two years, we continue to make considerable progress on our margin expansion initiatives. Of note, a comparison of the midpoint of the 2022 guidance versus the 2019 pre-pandemic levels, reveals a healthy 190 basis point increase in gross margin and a 220 basis point increase in operating margin. We believe our incremental investment is prudent to fuel our long-term durable growth initiatives, especially as we see the disruption from the current COVID surge improving over time. In turn, we view 2022 as a transition year for margins as it remain multiple levers to drive profitability higher over the coming years, including product mix shift, manufacturing efficiencies and announced restructurings, partially offset by continued investments in the business to sustain our durable growth profile. Moving down the P&L. We expect net interest expense to be approximately $51 million. The year-over-year decrease in interest expense largely reflects reductions in debt funded by proceeds from the respiratory divestiture and strong cash flow generation. Turning to taxes. We project that our adjusted tax rate will be in the range of 10.5% to 12.5% for 2022. Of note, the high end of the range reflects the change to the tax deductibility of certain R&D expenses beginning 2022 under the 2017 Tax Cuts and Jobs Act. We understand there is bipartisan support for these R&D tax benefits, leading to the potential that the provisions that became law for 2022 could be reversed at some point during the year. If the law is repealed, we would anticipate that our tax rate to be towards the lower end of the guidance range. Considering these elements, our adjusted earnings per share guidance for 2022 is $13.70 to $14.30, a 2.8% to 7.3% year-over-year increase. Inclusive in the guidance is an approximately $0.17 headwind associated with the divested respiratory business and approximately $0.33 for incremental inflation. Earnings per share growth, excluding the respiratory divestiture and incremental inflation is expected to be approximately 7% to 11%. As a reminder, the low end of our adjusted EPS growth range reflects the change in the R&D expense deductibility for tax purposes. We estimate that weighted average shares outstanding will increase to 47.7 million for the full year 2022. Lastly, I want to provide some additional color on the cadence of our 2022 financial results. Specifically, three items impacting our first quarter results. First, as I mentioned previously, our first quarter results are expected to be impacted by continued COVID-related headwinds on elective surgical procedures, similar to what many medical device companies are experiencing to date. Second, note that the first quarter has one less selling day as compared to the same period of 2021. Third, we expect the headwind from foreign exchange rates to be higher in the first and second quarters before moderating in the second half of 2022. Accordingly, we expect our reported revenue to be approximately flat year-over-year in the first quarter. On a days adjusted constant currency basis, our first quarter growth is expected to be approximately 3% to 3.5%. And when excluding the impact of the rest of respiratory divestiture, our days adjusted constant currency growth is expected to be roughly 5.5% to 6% in the first quarter. We also expect our adjusted gross and operating margin to decline year-over-year in the first quarter driven by incremental inflation and a normalization of operating expenses. That concludes my prepared remarks. I would now like to turn it back to Liam for closing commentary. Liam?
Liam Kelly:
Thanks, Tom. In closing, I will highlight our three key takeaways from the quarter and our 2022 outlook. First, our diversified product portfolio enables Teleflex to deliver constant currency growth of 7.9% in the fourth quarter and 8.8% for 2021 despite the significant disruption from COVID during the year. Second, we continue to execute on our strategy to drive durable growth across our diversified portfolio with investment in organic growth opportunities, margin expansion and deployment of capital for M&A. Third, we remain confident in our growth strategy. We see our core growth platforms driving 4% to 5% growth with the additional growth coming from UroLift as pandemic headwinds subside. We have levers in place to drive further expansion in our margins. And our balance sheet is in a solid position with leverage of 1.7x, providing ample financial flexibility for our capital allocation priorities. We remain confident in our future and our ability to continue to meet our commitments to patients, clinicians, communities and shareholders. That concludes my prepared remarks. Now, I would like to turn the call back to the operator for Q&A.
Operator:
Thank you. [Operator Instructions] And your first question comes from Jayson Bedford with Raymond James.
Jayson Bedford:
Good morning and thanks for taking the questions and the comprehensive review here. So I guess just to start and I hate to be too granular here. But maybe can you comment on what you're seeing in the environment today versus, let's call it, a month ago? And I just want to feel a little comforted that you are seeing a little bit of a pickup as COVID wanes.
Liam Kelly:
Yes. So right across our business, Jayson, obviously, we have winners and losers every time there's a COVID outbreak. So parts of our business do better, part of the them do worse. Vascular, obviously, in some of our respiratory filters do better. Our elective procedures, UroLift being the first one and then Surgical and Interventional tend to do worse. What we saw as we came through the end of August and the last outbreak, we saw, in particular, UroLift procedures pick up September, October, November. And then we saw them being impacted in December and that continued into January. We would expect then to see an improvement as hospitals reopen and as people feel more confident in going in and having these procedures done. So we would anticipate the environment improving in the month of February and in the month of March. And again, I've got to commend hospitals and docs offices and ASCs. They are managing the additional outbreaks much better. The issue with Omnicron was it was a lot more contagious. So it actually added to the staffing shortage with individuals having to isolate for five days once they were exposed to just because of the infectious nature of it. But yes, an improving environment in -- as we went through February, Jayson, to answer your question directly.
Jayson Bedford:
Okay. And just as a quick big picture follow-up. Liam, you made the comment in the release around optimizing the portfolio for growth which is consistent with past commentary. But I guess the question is, the current environment more or less conducive for your strategy? Meaning -- I'll ask another way, can you be more active in this environment?
Liam Kelly:
Well, the one thing you need to be active, Jayson, is firepower and we've got lot of firepower. So our leverage levels, as we said in the call, at 1.7x. So we have firepower. Let me answer it this way. I feel a lot better today than I did a year ago with regards to valuations. We always augment our portfolio. And don't forget in the last 24 months, we have acquired HPC and Z-Medica and we divested of our respiratory assets. We are active out there purchasing assets. I think valuation expectations have modified as the IPO market is modified. And it's not just us telling the private companies, that it's also the banking community, communicating that to them. So yes, I'm glad that we maintained our financial discipline over the last 12 months when it was pretty heavy out there. And I think it's -- we're having a lot of easier conversations with private companies now and they see a strategic exit as very, very favorable compared to an IPO at this stage.
Operator:
Your next question is from Lawrence Biegelsen with Wells Fargo.
Lawrence Biegelsen:
Hi, good morning. Thanks for taking the questions. Congrats on a nice end to the year here. Liam, starting with UroLift, what are you seeing from the recent reimbursement change? And big picture, the contribution to growth there. You talked about, I think, from 4% to 5%, your lift bridging to your long-term goal, I think, of 6% to 7%. How much growth -- where do you see that additional growth coming from? How much is from international markets? And what are the other drivers? And I had one follow-up.
Liam Kelly:
Yes, Larry. So with UroLift, first of all, we're really pleased with the strong finish to the year, $93 million in the fourth quarter. And indeed, our overall performance in the year and thank you for acknowledging it. I think we're really proud of what we did. We delivered revenue growth of 8.8% versus our original guidance of 8% to 9.5%. And don't forget, the original guide of $28 million to $32 million of respiratory revenue that we divested, delivered gross margins 59.4%, 270 basis points of expansion, up margin 310 basis points of expansion. And earnings per share, 25% growth in earnings per share, while also losing $0.10 to $0.15 in the respiratory divestiture. Looking forward, we've obviously communicated that we expect UroLift to grow 15% this year. We feel that, that's very achievable in the current environment. We expect it's going to be impacted by COVID in the first quarter as one would anticipate. And then we would anticipate lower single digits in the first half of the year and then picking up strongly in the back half of the year, obviously, an easier comp in Q3. And then going into Q4, as people work through their deductibles, you'd expect it to continue along that vein. We're really confident on our core business being well capable of 4% to 5%, Larry. And with good execution, I think we should be at the upper end of that range. So our growth algorithm of 6% to 7% is very, very much intact, as demonstrated in our guide today. So our constant currency guide is 4% to 5.5%. But there's 1.6% of a headwind from the respiratory divestiture, that's 30 basis points from the loss of a day which is in Q1 which actually gets you to 5.9% to 7.4%. So if anything, the algorithm has improved because of the base, our core business doing even better through good execution and really solid investment behind some of our good growth assets such as Intraosseous, such as our PICC portfolio, such as MANTA and such as our hemostasis portfolio.
Lawrence Biegelsen:
That's helpful. And for my follow-up, Liam, just to follow up on Jayson's question earlier on M&A. What are your criteria deal size? How are you thinking about deal size? And any areas of interest you can share? Thanks for taking the questions.
Liam Kelly:
Absolutely, Larry. So we look at assets that are in that $600 million to -- $60 million to $300 million in revenue. Our strategic criteria is that it fits within one of our pillars or in an adjacent space. It's got a really strong IP. Has a great value proposition within the hospital. Also has -- is clinically better than anything within the marketplace available. And we like products that are sticky. They get used over and over again. We obviously look for assets that are accretive to our gross margin. And we look for assets that are -- will become accretive to our op margin in time. We'll accept some shorter-term op margin dilution like we did, for example, with NeoTract as long as we can see leverage into the future. So those are really our financial and strategic criteria, Larry, and thanks for the questions.
Operator:
Your next question is from Matt Taylor with UBS.
Matthew Taylor:
Hey, thank you for taking the questions. Good morning.
Liam Kelly:
Good morning, Matt.
Thomas Powell:
Good morning.
Matthew Taylor:
Good morning. I just wanted to ask specifically on UroLift, the 15% guidance. Two things. One, could you help us a little bit more with the cadence of UroLift growth that you expect through the year? And how much contribution from Japan are you anticipating?
Liam Kelly:
Yes. Good question, Matt. So as I answered Larry, the first half will grow in the lower single digits due to the impact of COVID-19 through the first quarter and obviously, staffing shortages, while the second half of the year will grow really strong double digits. The contributions will be small from the international markets. You've got Japan, Brazil and France. They'll ramp in the second half of the year but they won't really become meaningful math until 2023 and beyond. So for this year, 2022, the main growth driver for UroLift will continue to be the United States. And I'll just add to that, Matt and I mentioned this in my prepared remarks that we trained through the pandemic. That is the most best tactical way to drive growth in UroLift in 2022 and then bring on the international markets in ‘23 and beyond. And obviously, you'll see places like China come into being in '23 and so we got a real great algorithm for growth for all of Teleflex and also from UroLift. And as Tom outlined in his prepared remarks, we've got 25% of our total revenue that is in that mid-teens growth which includes UroLift but as well as that, you've got MANTA and Hemostat and intraosseous and PICC, all driving that real solid top line growth for Teleflex.
Matthew Taylor:
Great. Thanks, Liam. And just a follow-up on the pipeline. Did you give an update on the RFP? Or could you give us an update on that, where that is?
Liam Kelly:
Yes. I did in the prepared remarks, Matt. So as I said in the prepared remarks, we've received the CRL and we are working on the information requested. The good news is the request from the FDA is not focused on clinical data and with clear line of sight on the additional information that the FDA is requesting. We will continue to interface with the FDA and it is very collaborative. But it's clear to us, Matt, this is also the first time the FDA has approved a biologic products such as this. So we're breaking new ground together. And as you're aware, Matt and as most investors will be aware, the RFP from the military within that $3 million to $4 million, it's a nice market in the future, it's $100 million that we'll grow into. But that $3 million to $4 million is not in our guidance for this year.
Matthew Taylor:
Great. Thanks, Liam.
Liam Kelly:
You too.
Operator:
Your next question is from Shagun Singh with RBC Capital Markets.
Shagun Chadha:
Great. Thank you for taking the questions. I was just wondering if you could just let us know what the impact is of inflation and FX on margins and EPS in Q4. And then what have you assumed in 2022? And then just with respect to margins, can you bridge us from '21 to '22? I'm just trying to understand the puts and takes. So as it relates to, I guess, UroLift 2.0 conversion, we have slightly less than 40 basis points inflation. I think you called out 70 basis points on the call, annual pretax savings. I think you have about $40 million in '22 and '23. And then just higher level of investments. If you can just bridge that, that would be helpful.
Liam Kelly:
Thank you, Shagun. That level of detail requires somebody called Thomas Powell. So Tom?
Thomas Powell:
Okay. So I think the first question was just on the impact of inflation or FX in inflation in the fourth quarter. So as we look at the fourth quarter, I'll start with FX first. What we saw was a bit of a move in the exchange rates. And some of the tailwind that we had been experiencing through the earlier part of the year lessened quite a bit. So it was an adverse impact on our margins relative to the prior year but still slightly positive on a year-over-year basis. As far as inflation, we had talked about inflation ticking up in the fourth quarter relative to what we were seeing in the third quarter and we had estimated the amount to be approximately $3 million. It actually turned out to be higher, close to $4.5 million in the fourth quarter. And we've obviously assumed that, that's going to continue to be some of the case going into next year. As we think about just margins as we go into next year, there are a number of puts and takes. First of all, I'd say that the gross margin, I'd like to remind everyone that it had increased 270 basis points in 2021 versus 2020. So really strong expansion in 2021 despite a higher inflationary environment. As we look to 2022, our guidance is 59.75% to 60.25%, representing an increase of 60 basis points at the midpoint. The gross margin increase, as mentioned, attributable to mix, mostly UroLift as well as restructuring and operational efficiency programs being partly offset by inflation. And for 2022, our guidance assumes that supply chain inflation is approximately $20 million higher than the 2021 inflation level and that equates to an incremental inflation impact of about 70 basis points. So if you were to look at our guide on gross margin, excluding the impact of that incremental inflation, we're up about 130 basis points at the midpoint. And as we think about the cadence of gross margin, we do expect to see a strengthening gross margin as we go throughout 2022. Right now, our guidance assumes -- or included in our guidance is an assumption that we will see some improvement in raw material and logistics inflation in the second half of the year versus the levels we're currently expecting. And we also expect to get a mix benefit as we go throughout the year as UroLift becomes a greater percentage of the mix and actually the manufacturing supply agreement becomes a lesser part of the mix. So I would say big picture, gross margin is impacted by inflation and the cadence of quarterly margin expansion impacted by both inflation levels as well as mix. Now as we look at the operating margin, we are guiding to 27.75% to 30.25% which is flat to 2021 at the midpoint. A couple of things, again, to highlight, first of all, is that increase in the supply chain inflation has an adverse impact to gross margin and that drops down to the operating margin. And then secondly, I do want to highlight that in 2020, we had significantly reduced OpEx spending as a result of the COVID pandemic, in part because the pandemic caused limitations on our commercial activities. But also in part because we wanted to reduce cost to offset the COVID revenue impacts. Now in 2021, we partially restored activities in spending but we weren't back to pre-pandemic levels of activity or spend. In 2022, our guidance assumes that we will largely resume normal commercial activities, including hiring, sales, training, meetings, et cetera. And as a result, we'll incur an incremental about $20 million or 70 basis points of OpEx in the year. So if you look at the op margin, excluding the impacts of the supply chain inflation and normalization of expenses, we'd see about a 140 basis point improvement at the midpoint. Now in addition, in 2022, we plan to continue to invest behind key growth franchises, including UroLift, MANTA and EZ-IO. I'd say that given the successes we've seen in the UroLift DTC as well as sales force additions, we'll continue to invest there as well as behind MANTA. And then again, we will see some op margin improvement as the year progresses for a lot of the same reasons that we're talking about in the gross margin improvement.
Shagun Chadha:
Yes. Thank you for all your color.
Thomas Powell:
Hopefully, I answered all your questions.
Shagun Chadha:
Yes. Appreciate it.
Thomas Powell:
Thanks, Shagun.
Operator:
Your next question is from Cecilia Furlong with Morgan Stanley.
Cecilia Furlong:
Hi, good morning and thank you for taking the questions. Liam, I wanted to start back on UroLift. Just -- you talked about initiatives to drive UroLift utilization in your existing position base. As well as drive adoption in newly trained positions. Can you walk through some of the kind of key points that you're focused on this year? And then kind of a bigger longer-term picture. But as you get out of COVID, as you think about all of the international markets coming online, Japan, China, Brazil, Europe as well, how do you think about just the durable long-term growth profile of UroLift?
Liam Kelly:
So I think once we get -- what's very clear to me to the latter part of your question, Cecilia, is that UroLift growth is impacted by COVID. We've seen this at every outbreak of COVID. And as I just said a few minutes earlier, we saw UroLift pick up in September through November quite substantially. And then obviously, in December, we saw it take a step back because of the outbreak of COVID. Notwithstanding that, we still exceeded our internal expectations because of the robustness of the growth in the first two months of the quarter. And the reason, Cecilia, that we're focused on a few pillars of growth for UroLift. The first pillar of growth is going to be around driving utilization in existing docks over the next number of years. What we've seen during COVID is our champions and our interventionists. And remember, these are people that almost predominantly to a very, very high percent only offer UroLift. And because of reluctance in patients, because of staffing shortages, we've seen their utilization drop a little bit through the COVID environment. So, the easiest way to get UroLift back in to drive that 15% growth is drive utilization there. The second point is, for the future is to continue to do that but also to expand overseas. And you'll see Japan coming in beginning in April 1. You'll see France in the back half of the year. You'll see Brazil continue to move as we go through the year. You'll see China come in next year. Maybe then somewhere like Taiwan, you'll see -- pardon me, Italy and Spain come along. So most companies would expect the revenues they do in the U.S., if you execute well overseas, you should do almost the same amount of revenue overseas over a multiyear period. And then lastly is obviously bringing on new docs. We continue to train new docs as we go through the year. And I think that it's important for everybody to realize we haven't penetrated this market by any stretch of the imagination. We've only trained about 3,400 docs out of 12,000. And we've only done 300,000 procedures, almost all of them in the United States out of 12 million men in the United States and 100 million globally. So the opportunities for growth over a multiyear period, I feel really encouraged by and we just want to get COVID in the rearview mirror and then really show what this product can do from a growth profile.
Lawrence Keusch:
And Cecilia, it's Larry. I would just mention that we will obviously provide a longer-term view of our outlook for UroLift at our May Analyst Meeting.
Operator:
Your next question is from Mike Matson with Needham & Company.
Michael Matson:
Hi, thanks for taking my questions. I wanted to ask about the UroLift reimbursement changes that happened. I think that went into effect at the beginning of the year. So can you maybe talk about what you're seeing there? Have you seen maybe the physicians changing site of care or anything else? And with the 15% guidance, how much have you factored in, if anything, for that issue?
Liam Kelly:
So, we haven't seen any site of service change and I don't anticipate seeing any site of service change in the coming year. The law that was signed in by President Biden actually improved the reimbursement for the UroLift in the office procedure by changing the conversion factor by about 3%. That actually added another $100 to $150 net to the urologist for doing this procedure. We've also implemented our own pricing strategy in the marketplace and that has been incredibly well received. Only six weeks into it, a very high percentage of our customers have signed up to our plan. So I would envision a very -- I wouldn't envision much of the shift inside of service. And Mike, don't forget as well, 70% of our UroLift cases are done outside of the office. And the CMS ruling only impacted Medicare Medicaid patients in the office which, if you do the math, is about 20% of the total. So we have strategies in place. The team is executing and the 15% growth is predicated on everything that we know today and our knowledge of what's going to happen with COVID we move forward throughout the year.
Michael Matson:
Okay, thanks. And if I could just slip one in for Tom quickly. Is there any kind of EPS impact from currency? I did hear that called out and you kind of walked through the headwinds. But just given that it is meaningful to the top line, I wanted to see if it was getting kind of offset on the bottom line. Thanks.
Thomas Powell:
So the currency impact that we've assumed in our guidance is about $0.20.
Operator:
Your next question is from Matthew Mishan with KeyBanc.
Liam Kelly:
Hello Matt.
Matthew Mishan:
Can you hear me?
Liam Kelly:
Yes.
Matthew Mishan:
Okay, excellent. Just the first question on Vascular Access. That continues to exceed our expectations and it's about $100 million above where you were at in 2019. It seems like you're pretty confident around PICC and Vidacare as you're kind of moving those into the high-growth category. I'm just curious, how should we think about the durability of the improvement in Vascular Access versus maybe some of the other areas that may have been COVID-related beneficiaries?
Liam Kelly:
Yes. So for Vascular Access, this year, we expect it to grow in the mid-single digits in it's entirety. Obviously, our CVC portfolio benefited from COVID over the last couple of years. But the growth is really coming from our intraosseous portfolio and also from our PICC portfolio as we continue to take share because of our coating technology. This is really a global play for us. We've launched a really nice new CBC kit that is getting excellent traction out there in the market globally and that's also helping uptrade our customers on our CBCs in our key -- globally but in our key North American market for sure. So we feel really good. It's our largest franchise, Matt. It continues to execute incredibly well. We have a new -- as well as that new product, we have another new product that's coming around our PICC, positioning in our PICC that we're very excited about. And so this is one of the -- we've often said not all growth is equal. This is one of the businesses that gets more R&D dollars spent than others. And keeps that flow and new products come to keep ourselves differentiated and it's a great franchise.
Matthew Mishan:
Okay, excellent. And then, just an update -- and I'm sorry if I missed it, on where Z-Medica ended for 2021. And thoughts on growth drivers for that product into next year.
Liam Kelly:
Yes. We're really happy with where Z-Medica finished. We told the investment community to be somewhere between $60 million to $70 million. We finished squarely in there $66.5 million. Really proud of the achievements, bringing that into Teleflex. And nothing is changed in our outlook. That's well capable of high single, good execution, low double-digit growth and really accretive to our margins, again, another growth driver. And that's in the bucket that Tom spoke about, that's driving an average in the mid-teens. And of course, we have a cardiac study that we just completed, we will file with the FDA. And that will expand the $600 million TAM also, Matt. So, really excited about it.
Operator:
And your last question comes from David Turkaly with JMP Securities.
David Turkaly:
Great, thanks. Maybe just a couple of quick product one to follow up on that. The PICC side, would you notice anything on the competitive front, there was a bigger player there that grew for years at the rate that you seem to be now. Has anything changed there? Or would you actually point to the differentiated coatings as sort of how you're maintaining that?
Liam Kelly:
So for us, it's all about the coatings. And what changed, Dave, was in the past, hospitals didn't have to report infections on PICCs. And the assumption was when they weren't measuring it, the assumption was that the PICC infections were lower. PICC infections on CBC is used to be at 4% before we launched our coated technology on the CBCs. And with -- many studies have shown we've been able to bring it down to practically 0. And of course, once they started measuring PICC infections, they were around 4%. So now hospitals don't get reimbursed for those infections. And that's why we're being so successful with our PICC technologies. It's really around our coatings that are both antithrombogenic and anti-infectious.
David Turkaly:
Thank you for that. And maybe just a follow up. An area we don't talk about a lot but on surgical, you mentioned instruments and ligation clips. But 16%, even if there's procedure bounce-back, seems high. I guess what is happening there? What is differentiated there? Or how are you able to put up numbers like that in an area that I would think would be a much lower growth opportunity?
Liam Kelly:
Yes. Also within -- this is also a global play for our Surgical business. So we have a really strong Surgical business in the Americas and in APAC. And as procedures bounced so did our Surgical portfolio. But we're also working on expanded indications for our coal ligation clips that should help us continue to augment the growth. Now it's not going to grow at that clip for next year and I don't want to mislead anybody that is going to do that. It will be in the low single digits as we go through next year. But we are -- we have some new products coming down the -- this year -- sorry, I said next year, this year, 2022, it will grow in the low single digits. But we have some nice pipeline of products coming through there and we've expanded our vascular closure. We've really like working on our instruments. And of course, it holds like as we continue to perform exceptionally well globally. And quite frankly, the team in Surgical has done an outstanding job in executing as procedures have returned. And also an area that we take price, I should mention that. It's a nice opportunity for us. And on pricing I think it's important that we did mention, we anticipate having positive pricing this year on that 50 basis points consistent what we drove last year in order to offset some of the inflationary pressures. And it's for a company by Teleflex, I believe that will be successful because we're used to taking prices out of our DNA and we'll continue to execute on that price, in particular, with Surgical within our Vascular business unit and also overseas in Asia and Europe. So, I just want to make a point as well before we close. Thank you.
Operator:
That is currently all the time we have for questions this morning. I will now turn the call back to Mr. Keusch for closing remarks.
Lawrence Keusch:
Thank you, April and thank you to everyone that joined us on the call today. This concludes the Teleflex Incorporated Fourth Quarter 2021 Earnings Conference Call.
Operator:
This does conclude our conference for today. Thank you for your participation. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to the Teleflex, Third Quarter of 2021 Earnings Conference Call. [Operator Instructions] And now I would like to turn the call over to Mr. Lawrence Keusch, Vice President of Investor Relations and Strategy Development.
Lawrence Keusch:
Good morning, everyone. And welcome to the Teleflex Incorporated third quarter 2021 earnings conference call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing (800) 585-8367 or for international calls (416) 621-4642 using the passcode 4079822. Participating on today’s call are Liam Kelly, Chairman, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks and then we will open the call to Q&A. Before we begin, I’d like to remind you that some of the matters discussed in the conference call will contain forward-looking statements, regarding future events as outlined in our slides. We wish to caution you that such statements are in fact forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include but are not limited to factors referenced in our press release today, as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. During this conference call, you will hear management make statements regarding intra quarter business performance. Management is providing this commentary to provide the investment community with additional insights concerning trends. And these disclosures may not occur in subsequent quarters. With that said, I’ll now turn the call over to Liam for his remarks.
Liam Kelly:
Thank you, Larry. And good morning, everyone. It’s a pleasure to speak with you today. For the third quarter Teleflex generated double digit constant currency revenue and 27% adjusted earnings per share growth on a year-over-year basis, despite a greater than expected headwind from increased COVID-19 infections due to the delta variant. All of our global product families grew on a constant currency basis year-over-year, with the exception of our other category due to the divestiture of the respiratory assets to Medline. Although we encountered a change in macro-trend versus expectations at the time of the second quarter, the solid performance for Teleflex during the third quarter of 2021 reflects the diversified nature of our business and the benefits of the company’s broad portfolio of medically necessary products and category leadership. Our six primary product families on broad global footprint have offset pressure on product revenues associated with elective surgery that were subject to pauses during the third quarter. As many investors would be aware, there were restrictions on elective surgical procedures in as many as 28 states during the third quarter. However, as we have seen since the pandemic began, our broad-based portfolio provides a hedge in periods of increased COVID activity with more than 60% of our business, either benefiting from increased COVID-related treatments or remaining relatively insulators from disruptions due to the pandemic. Although we do not routinely provide intra-quarter commentary, given the larger than expected surge in COVID-19 infections from the desert variant, I will share some details for the third quarter. Relative to guidance provided at the time of our Q2 earnings report, we saw a greater than anticipated pause in elective surgical procedures across select geographies in the U.S., Europe and Asia. However, as COVID-19 infections trended down, we saw our average daily sales for products, most exposed to elective surgical procedures begin to improve as we progressed through September. During the third quarter, our Americas, EMEA, Asia and OEM segments demonstrated resilience with all the regions showing constant currency revenue growth over 2020, despite the headwinds from the Delta variant. As I mentioned earlier, this underscores the benefit of our diversified product portfolio. For the third quarter gross and operating margins exceeded levels achieved in 2020 and 2019 incomparable periods. Our continued progress in margin expansion in 2021 has allowed us to increase directed investments towards growth drivers, which is an important component of our long-term strategy to enhance durable growth. As we look to close out the year, we anticipate some modest improvement through the fourth quarter as compared to the third quarter, but acknowledge that the macro environment is not yet where we had expected it would be at the start of the year. We remain cognizant of uncertainty around COVID-19 infections, as the weather turns colder in the northern hemisphere, new variants and healthcare worker shortages. Accordingly, we believe that it is prudent to assume that COVID-19 would remain a headwind and that our broad-based return to elective surgical procedures to normal volumes is unlikely during the fourth quarter. We anticipate these elements to be transitory in nature. And we expect a more normalized environment to be established in 2022. Given our year-to-date results and outlook for the fourth quarter, we are reducing our constant currency revenue growth to a range of 8% to 9% from 8.5% to 9.75% previously. The revision in the constant currency growth outlook is primarily driven by lower growth expectations for products used in elective surgical procedures. However, given strength in our operating margin performance and improvements in our balance sheet, we are increasing earnings per share guidance to arrange of $13.15 to $13.35, versus our previous range of $12.90 to $13.10, implying growth of 23% to 25% year-over-year. Turning to a more detailed review of our third quarter results. Third quarter revenue was $700.3 million, an increase of 10.3% year-over-year on a constant currency basis. The year-over-year increase reflects the benefits of our diversified portfolio and was driven by contributions from all business segments obsessed by the impact of COVID-19 and the divestiture of the respiratory assets to Medline. In comparison to the comparable period in 2019 third quarter revenue increased 5.8% and demonstrators accelerating quarter-over-quarter growth in our vascular OEM and anesthesia businesses, which offset sequential deceleration in areas of the business more exposed to the surge in COVID-19, including Interventional Urology, Interventional and Surgical. Third quarter growth and operating margin performance exceeded our expectations reflecting the strength of our diversified portfolio actually obsessed by greater than anticipated headwinds from COVID-19. Our year-to-date margin performance is an encouraging sign for our longer-term profitability objectives. Third quarter adjusted earnings per share of $3.51 increased 26.7% year-over-year and exceeded our internal expectations, despite higher than anticipated headwinds from COVID-19 on our adjusted earnings per share results in the third quarter, the year-over-year performance reflects growth in our diversified product portfolio, modest price increases, gross margin expansion and better than expected operating expense management. We continue to execute on our strategy to deliver durable growth with investment in organic growth opportunities, product innovation, margin expansion, and deployment of capital as per de-leveraging our balance sheet and M&A. I am proud of how the team continues to execute in a challenging environment. Our third quarter financial performance demonstrate the resilience of our diversified global product portfolio are tired of that investment in growth drivers, including UroLift and MANTA, but also reflecting progress towards our longer-term margin aspirations. Turning now to a deeper look at revenue results. I would begin with a review of our reportable segment revenues. All growth rates that I refer to are on a constant currency basis unless otherwise noted. Americas revenues were $417.3 million in the third quarter, which represents 10.9% growth year-over-year, contributors to the year-over-year growth were Surgical, Vascular and Interventional, partially offset by the impact of pauses in elective surgical procedures. EMEA revenues up $143.9 million increased 3.6% year-over-year with Interventional and Vascular products leading the growth. EMEA benefits from a favorable COVID-19-related as comparison due to improved procedure volumes year-over-year as countries across the region continued to open up despite disruptions related to COVID-19. Turning to Asia. Revenues were $75 million increasing 6.3% year-over-year. Japan was strong in the third quarter growing north of 30%, but it was partially offset by the impact of COVID-19 in Southeast Asia. Let’s now move to a discussion of our third quarter revenues by global product category. Consistent with my prior comments regarding our reportable segments commentary on global product category growth would also be on a constant currency basis and ranked by size of our business units. As a reminder, there were no meaningful differences in year-over-year selling days in the third quarter. Starting with Vascular Access. Third quarter revenue increased 8.5% to $175.5 million, peak portfolio continues to position us for dependable growth. Our Vascular Access portfolio remains important in this – the treatment of COVID-19 patients, driving strength in the third quarter, due to increased rates of Coronavirus infections. Our peak portfolio continues to perform well with 10% growth year-over-year. We continue to invest behind our differentiated peak portfolio and are taking market share. Intraosseous was also solid in the third quarter with growth of 12% year-over-year. Moving to Interventional, third quarter revenue was $104.3 million, up 10.4% year-over-year. We executed well during the third quarter, although increased COVID-19 infections still with complex PCI and TAVR procedures. We continue to invest behind our Interventional portfolio, including complex catheters and MANTA are large foreclosure device. MANTA momentum remains from both in the U.S. and in international markets with over 80% global growth year-over-year in the third quarter. Given the year-to-date performance from MANTA, we are confident in our ability to achieve 8% share in 2021 of the $200 million to $300 million, up 26.6% year-over-year. Products from Z Medica contributed roughly 85% of the growth as the business continues to track to our $60 million to $70 million revenue expectations for 2021, partly offset by lower sales of tracheostomy products. In our Surgical business, revenue was $92.8 million, representing 10.9% growth year-over-year. Among our largest product categories, we witnessed robust growth in sales of our ligation clips and instruments as the elective surgical procedure environment for Interventional Urology people in $1 million, an increase of 1.5% year-over-year and below our expectations at the time of the quarter two conference calls. The quarter was impacted by elective surgery cancellations due to state restrictions and ICU capacity limitations as Delta variant infections rule sharply in certain regions of the U.S. as well as continued business disruption associated with the pandemic. We are closely monitoring trends in our UroLift business. Importantly, our analysis of commercial and Medicare billing claims over the past six months indicate that UroLift has not lost market share to competing minimally invasive treatments for BPH and remains the leading procedure. We continue to see COVID-19 as having the most significant impact on UroLift utilization with physician office staffing shortages also disrupting the business. We see both of these impacts as transitory in nature and expect a more normalized environment in 2022. The preference for UroLift continues to be driven by strong clinical results with studies showing rapid symptom relief and recovery. No new sustained sexual dysfunction and durable results. Indeed, our analysis shows that very few of our experienced users offer other technologies for the treatment of BPH, given their confidence in UroLift. The UroLift System remains distinct from other device-based BPH treatments and we intend to maintain our leading market position in day surgery treatments for this condition. We continue to target patients that are suffering from BPH and have either failed or are not satisfied with drug therapy, a population that is estimated to be 1.5 million men in the United States. As we look towards the fourth quarter of 2021, we are assuming a relatively stable macro environment as compared to our September trends, given lingering COVID-19 headwinds for elective surgical procedures. When taking into account, the softer than expected UroLift revenues during the third quarter and our recalibration of the fourth quarter, we are reducing our 2021 Interventional Urology revenue growth guidance to 15% to 17% year-over-year. We would anticipate a more normal environment for elective surgical procedures to emerge during 2022. We remain encouraged by the physician engagement as measured by our active users, new physician training, and the ability to perform UroLift procedures in all relevant care settings. Our OEM business, accounts for roughly 9% of total sales increased 29.4% year-over-year to $64.1 million in the third quarter. We continue to see strength in our OEM business as customer ordering normalizes and we remain well positioned in our markets with customers valuing our design and manufacturing capabilities. And finally, our other category, which consists of respiratory products that were not included in the divestiture to Medline manufacturing service agreement revenues and urology care products declined by 4.3% to $83.4 million year-over-year and growth in urology care. We continue to expect manufacturing service agreement revenues to phase out at the end of 2023. That completes my comments on the third quarter revenue performance. Turning to some commercial updates and starting with UroLift. In the third quarter, we trained 124 urologists. Interest in UroLift remained strong. And with over 355 doctors trained in the year-to-date, we remain positioned to meet our training targets of 450 to 500 urologists in 2021. Turning to our consumer marketing efforts. We continue to view direct-to-consumer as a multi-year catalyst for UroLift in the United States. We have continued to fund our DTC campaign to prime the pump for the recovery and the elective procedures. I’m going to keep inventing in the fourth quarter. We recently won a bronze award for best new branded television campaign from DTC perspectives, which is a meaningful accomplishment given 13 finalist. Search interest for UroLift remains high and well above other minimally invasive BPH treatments with the majority of urologists surveyed, continuing to report patients asking for the UroLift System. Moving to UroLift 2. We remain on a full rollout in the United States. We formally launched the product as well as the UroLift ATC to the broad urology community at the AUA Meeting in September. We are well positioned to convert the majority of physician customers to UroLift 2 by the end of 2022 fueled by advantages and tissue compression, reduced storage space and increased manufacturing capacity. UroLift 2 remains an important margin driver. As we remained positioned to generate 400 basis points of UroLift gross margin expansion as the revenue base is fully converted. Regarding Japan, we continue to make progress towards an upcoming commercial launch for UroLift. Recently, the three major Japanese urology societies agreed on guidelines for UroLift usage, which is a positive development. As for reimbursement approval, we remain highly engaged with the MHLW and have been officially notified that UroLift will be reviewed at an expert panel in November. Although, we cannot control the timing of the regulatory pathway, the panel confirmation is an important milestone towards reimbursement in Japan, marking one of the final steps in the process. There is no change to our baseline assumptions that our commercial ramp will begin in 2022. Japan remains an important long-term opportunity for UroLift with a $2 billion TAM and we are excited for our upcoming launch. We continue to expect our sales in the region to ramp in a similar fashion to the U.S. in a market that is one-third the size. Aside from Japan, our international regulatory and commercialization efforts for UroLift remain active. On another positive note, we are excited about our initial commercial activity in Brazil. Although, we had been expecting to enter Brazil in late 2022, we have been able to shorten out after 2021. We have made good progress with select key opinion leader training and initial UroLift cases have already been performed in the hospital and office setting. Although, it is early and the market will take some time to develop. Brazil remains an important geography in our expansion of UroLift outside of the United States. And we are quite encouraged by the early experience. On the U.S. reimbursement front, and as a reminder, CMS published its proposed Physician Fee Schedule for calendar 2022 on July 13, 2021. The proposed rule would negatively impact reimbursement for roughly 600 procedures performed in the doctor’s office across a broad range of surgical specialties, with the disproportionate hit to device heavy procedures, such as UroLift. Teleflex provided a detailed response to CMS during the public common period regarding our position on the proposed rule. We believe that the changes to the Physician Fee Schedule would limit healthcare access for Medicare patients and shift procedures to more costly sites of service. Teleflex along with numerous other stakeholders have urge CMS to postpone the implementation of the proposed Physician Fee Schedule until additional analysis can be performed given the unintended consequences of the current proposed rule. We anticipate that the final rule will be published in November, consistent with historic timing. Turning to vascular. We are pleased with the performance of our reasons they launched Arrow ErgoPack kit, which contributors over $5 million in revenue during the third quarter. Among other improvements, the new kit configuration for our CVC catheters as a Nitinol Guidewire, which kink resistant and an enhancement that clinicians find beneficial. Given our leading market share in CVC, the launch is a trade of strategy that drives incremental gross profit dollar and help sustained our dominant market leadership position in CVC. Lastly, on our acquisition of Z-Medica, which was completed in December of 2020. The integration that Z-Medica continues to track slightly ahead of our internal milestones and we are pleased with the progress we are making. Regarding potential label expansion opportunities for the hemostatic portfolio we have completed patient enrollment in a 231 patient IDE study evaluating the performance of QuickClot Control+ hemostatic devices for mild’s-to-moderate bleeding in cardiac procedures as compared to standard goals. We intend to File a 510-K for expanded use of QuickClot Control+ following the completion of the study. That completes my prepared remarks. Now I’d like to turn the call over to Tom for a more detailed review of our third quarter financial results. Tom?
Thomas Powell:
Thanks, Liam, and good morning, everyone. Given the previous discussion of the company’s revenue performance, I’ll begin with the gross profit line. For the third quarter, adjusted gross margin totaled 59.5%, a 230 basis point increase versus the prior year period. The year-over-year increase in gross margin was driven by product and regional mix, benefits from cost improvement initiatives, favorable impacts from pricing, M&A and foreign exchange partly offset by raw material and distribution inflation. Third quarter adjusted operating margin was 28.5% or a 340 basis point year-over-year increase, driven by the gross margin improvement as well as disciplined expense management and partially offset by planned investment in the business. For the quarter net interest expense totaled $11.8 million, a decrease from $16.4 million in the prior year period. The year-over-year decrease in net expense reflects savings from the redemption of the 2026 notes, and also includes the impact of debt pay down using the proceeds of the respiratory divestiture and operating cash flows. Our adjusted tax rate for the third quarter of 2021 was 11.3% compared to 7% in the prior year period. The year-over-year increase in our adjusted tax rate is primarily due to a lower benefit from stock based compensation compared to the prior year period. At the bottom line, third quarter earnings per share increased 26.7% to $3.51; included in this result it’s an estimated favorable impact from foreign exchange of approximately $0.13 per share versus prior year. Turning to select balance sheet and cash flow highlights. Year-to-date, cash flow from operations total of $450.5 million compared to $241.5 million in the prior year period, and represented a year-over-year increase of $209 million. The increase was primarily attributable to favorable operating results, lower contingent consideration payments, lower payroll and benefit related payments and proceeds received under the manufacturing supply agreement with Medline. Moving to the balance sheet, our financial position remained sound. At the end of the third quarter 2021 our cash balance was $481.2 million versus $375.9 million at the end of the fourth quarter of 2020. As noted previously, we made a $259 million payment in July against our revolving credit facility using funds primarily generated from the initial close of the respiratory business divestiture. At the end of the third quarter we had $342 million drawn on a revolver and net leverage was approximately 2 times. Now moving on to our 2021 guidance update. Starting with revenue, we are adjusting our 2020-2021 constant currency revenue growth guidance to a range of 8% to 9% year-over-year compared to 8.5% to 9.75% previously. Revised outlook reflects the benefits of our diversified portfolio, offset by lower UroLift revenues. Due to the recovery in elective surgical procedures progressing at a slower rate than what our prior 2021 financial guidance had assumed. Turning to currency; we continue to assume a 2% tailwind to reported revenue from foreign exchange rates in 2021, which is unchanged from our previous assumption. As a result, we are reducing our as reported revenue growth guidance to 10% to 11% year-over-year versus 10.5% to 11.75% previously. The updated guidance would equate to $1 range of between $2.791 billion and $2.816 billion. Now for some commentary on our margin outlook. We are lowering the top end of our 2021 adjusted gross margin guidance by 25 basis points to a range of between 59.25% and 59.5%. On a year-over-year basis we expect gross margin expansion to be driven primarily by a favorable mix of high margin products, including interventional urology, interventional access and surgical programs partially offset by inflation. Relative to our prior guidance, the revised outlook is associated with lower UroLift remittance. There’s no change to our expectation at Z-Medica will add approximately 50 basis points to gross margin for 2021. On the topic of inflation, we continue to experience increased cost pressures in raw materials, freight and to a lesser extent labor. Additionally, at the end of 2020, we had entered into contracts for sea freight lanes in order to lock in pricing at that time. The majority of those contracts expired at the end of September with remainder expiring at the end of the year. As a result of the expiring shipping contracts and increasingly inflation we now estimate that inflationary cost will be roughly $3 million higher in the fourth quarter than what was incurred in the third quarter. This impact is reflected in our revised guidance for gross margins. For adjusted operating margin we are increasing our 2020-2021 guidance range to 27.5% to 28%, representing an increase of 75 basis points at the low end and 50 basis points at the high end of the range versus prior guidance. The increase in adjusted operating margin reflects the year to date performance partially offset by the lower gross margin outlook. Moving down the P&L. We now expect interest expense to be roughly $57 million versus our previous guidance of $60 million to $62 million, partly reflects a reduction in debt, funded by proceeds from the respiratory divestiture and our strong cash flow generation. On taxes we now expect our adjusted tax rate for 2021 to be roughly 12% to 13% versus the prior range of 13% to 13.5%. Considering all of these elements, we are raising our adjusted EPS outlook for 2021 by $0.25 at the high and low end of the range to $13.15 to $13.35, a 23.2% to 25.1% year-over-year increase. And that concludes my prepared remarks. I would now like to turn it back to Liam for closing commentary. Liam?
Liam Kelly:
Thanks Tom. In closing, I will highlight our three key takeaways from the quarter. First, our diversified product portfolio enables Teleflex to deliver double-digit constant currency growth in the third quarter, even with greater than expected disruption from COVID-19. Second, we continue to execute on our strategy to drive durable growth across our diversified portfolio with investment in organic growth opportunities, margin expansion, and deployment of capital for M&A. Third, we raised our earnings per share guidance for 2021, reflecting 23% to 25% earnings growth year-over-year. In closing, we feel good about our overall performance in the quarter, which was anchored by our diversified portfolio of medically necessary products. Our balance sheet is in a solid position which leverage at 2 times providing ample financial flexibility for our capital allocation priorities. We remain confident in our future and our ability to continue to meet commitments to patients, clinicians, communities, and shareholders. That concludes my prepared remarks. Now I would like to turn the call back to the operator for Q&A.
Operator:
Thank you. [Operator Instructions] And now our first question comes from Matt Taylor from UBS. You’ll answer open.
Matt Taylor:
Hey, good morning. Thanks for taking the question. The first thing I wanted to ask you about was what you’re assuming for Q4 and recent trends? In – from the commentary that you made about the environment it seems like you’re assuming stability with some of this subdued trends that you saw in late Q3. And so I just want to make sure that was correct and get any color on what you’ve actually seen happen in the early part of Q4?
Liam Kelly:
Matt, thank you very much for the question. I think that as we look into the fourth quarter, we have to start with what we saw in the third quarter, and we’re really pleased with our revenue results which were better than our expectations and clearly demonstrate the advantage of a global diversified portfolio. In the quarter, even though certain elective aspects of our business, such as UroLift Intervention Access and Surgical were impacted by COVID. We still met expectations for revenue in that tough environment and exceeded our expectations on margins and EPS. I mean, EPS actually grew 27% within the quarter. And Q3 would deliver growth of 10.3% over 2020, and nearly 6% over 2019. We saw strength in OEM, the Americas, EMEA and APAC. And in fact, Matt, EMEA and APAC would have grown 6.8% and 12.2% respectively when you normalize for the impact of the respiratory divestiture. We also saw a strength within many of our segments, surgical interventional, vascular and anesthesia. And our key growth drivers ex-UroLift continued to deliver really solid results. MANTA grew 82%, and [indiscernible] grew 12%, [indiscernible] grew 10% and to your question, as we’ve progressed through the quarters, procedure volume did not recover in-line with our original expectation and we’re not as far along on the recovery slope, as we had hoped. UroLift is clearly a deferrable procedure and I would look at it as revenue deferred rather than revenue postponed. Procedures began to be impacted in the second half of July, but we did see improvements Matt in September within all of our procedure volumes that were impacted. And if you look at our assumptions for UroLift in particular and our updated assumptions for UroLift, the lower end of the range would be attributable to a flat lining of what we saw in September through the end of the year in that regard. I don’t really want to get into the specifics of Q4 Matt because there’s only one quarter left and clearly our guidance outlined what we’re expecting in Q4 from all aspects of our business.
Matt Taylor:
Okay. All right. Thanks. Make me elect all that color. Maybe I could just ask you one question about the UroLift reimbursement and obviously we’ll see what happens here over the next week or so would the final outcome of the orthopedics reimbursement? How are you preparing for some of the different scenarios? If the cut stays or if there’s a phase-in or hopefully there’s something better, but maybe you could talk about what you think the company would be to do under some of those different things that could – could happen to help physicians maintain their business in the office or move it to the AFB if they have to?
Liam Kelly:
Yes. So you’re correct Matt, there is no update as we sit here today and we would expect the proposed ruling to come through in early next month. That’s the normal timeline for us. We’ve really put a strong case to support the CMS, rethink of the proposed ruling. We believe it will limit Medicare and Medicaid patient access to over 600 procedures and we still believe the appropriate action is to cancel the proposed ruling and engage with key stakeholders on the new proposal. As I’m not sure the investment community is aware, but there were over 30,000 comments during the comment period and we believe that CMS is duty bound to take all the comments into consideration. We, when their final ruling comes out, we anticipate issuing a press release Matt on the publication. We have certain advantages over other minimally invasive procedures in, so far as we have flexibility with size of service. The UroLift procedure is profitable, not only in the office, but also in the ASC and the hospital and the vast majority of urologists that do the procedure in an office have parent ownership or access to an ASC and have that level of flexibility. So we’ll wait for the final ruling, Matt, and then we will make a decision on how we will proceed. But rest assured, plans are, of course, within Teleflex to move quickly once we get the final ruling.
Operator:
Our next question comes from to Cecilia Furlong from Morgan Stanley. You line is open.
Cecilia Furlong:
Hey, good morning. And thank you for taking the questions. Liam, I wanted to continue with UroLift and ask if you could talk about just procedure deferrals either the impact that DTC may have had during the quarter or just COVID pressure? But as you think about 4Q what you contemplated from potentially being able to recapture those procedures? And also, how you are looking at the environment today from a deferral, recapture perspective versus what played out in the March, April timeframe?
Liam Kelly:
Yes. So, I’ll started with the last bit of it. I think that hospitals are much better able to adapt to the COVID environment. And I think they’re managing the subsequent waves much better. And from that, we do anticipate 150% the number of impressions and we’re well on track [indiscernible] three quarters to get to those number of impressions. The number of patients responding through the campaign continues to have a similar uplift and we’re really encouraged by that. What we see as we go into the future, as I said earlier, is that the low end of the range implies the flat-lining of our September run rate for the remainder of the year. Now, Cecilia to your point on the deferral procedures and other aspects, we do expect to see some seasonal improvement due to the deferral, and also due to patients using up their deductible during the year, as we have seen in previous years. And we would also expect to enter into normal trading environment in 2022. And the market opportunity hasn’t changed. I mean, I think, that’s the most important thing. There’s still 12 million men that suffer with BPH. Urolift is still the go-to product for the treatment of BPH. And we still only done party just over 300,000 procedures, all of those 12 million men. And we still only trained 3,000 out of the 12,000 urologists. So, we’re still have a significant, a massive opportunity to continue to convert that customer base. And our own observation is that the procedures just deferrable more so than we would’ve thought quite frankly, when we bought the company. And also no one would have anticipated COVID in that environment. And we do think that there are three aspects that are impacting the product, restrictions and fear of COVID. I think number two, scheduled procedures that are subsequently canceled. And number three, and the lesser impact is really [indiscernible].
Cecilia Furlong:
Okay, understood. I didn’t want to ask just on staffing shortages as well, and of the impact that you’ve seen there either throughout 3Q, but then more recently, if that is a growing issue? And then also how you’ve seen site of care shift this quarter versus what you saw earlier in the year with some cases being pushed into the office, that I’m just curious if you’ve seen similar trends or is that stayed more in line with your traditional breakout? Thank you.
Liam Kelly:
Thank you. It’s pretty aligned with what we saw traditionally Cecilia regarding that we do see daycare procedures in hospitals rebounding and that’s one of the trends that we’ve seen. Regarding your question in staffing shortages, we would anticipate that the staffing charges would improve as we go through Q4 and into 2022. And that’s simply because it’s not doctors that the issue that a lot of the ancillary workers that are within the office, the AAC and the hospitals, and a lot of those people, unfortunately were furloughed in the midst of COVID. They have been receiving government checks. The government checks began to dry up in September. So, we would anticipate a bolus of those individuals coming back into the workforce in Q4 and into 2022. And we would anticipate seeing that environment improve also.
Operator:
Our next question comes from Anthony Petrone from Jefferies. Your line is open.
Anthony Petrone:
Great, thanks. And good morning, everyone.
Liam Kelly:
Good morning.
Anthony Petrone:
Maybe Liam, just a high level on the nursing shortages where we’re hearing it on several calls. It seems to be more pronounced in certain areas of the ICU critical care. But there are other specialty areas that are seeing shortages as well. So just from a high level, how substantial of an overall impact do you think nursing and hospital staffing shortages was in 3Q? And if you use your crystal ball looking into 2022, how long of a headwind do you think this is? Is it transient, or does it bleed deep into next year? And I’ll have a follow-up on Urolift.
Liam Kelly:
Yes Anthony, I think, there is a difference inside of service, quite frankly. In the hospital environment, my observation is that the staffing shortages is fatigue. A lot of these people are just exhausted from fighting COVID. And we’ve seen a lot of retirements as well in the nursing environment. I think that’s going to take a little bit longer to work through. I think we may have to consider the importation or the acceleration of nursing through the education process or the importation of nursing through the issuance of visas to up to other jurisdictions. I think then if you look at the AAC and the office, and in particular, the office, the dynamic here, Anthony, is that these people were furloughs in the midst of COVID, because office – a doc working in an office is like a small business. So, they have to try and protect their cash flow, they furlough the people. Those people went down to government assistance. Now the government assistance dried up in around September that timeframe. So, I would anticipate that would probably rebound a little bit faster simply because those individuals would want to come back to the workforce in order to generate an income. So that’s how I would see it. And if you recall Anthony, we did call out staffing shortages in Q2. I think we’re one of the fewer companies to start identifying it a little bit earlier on the trend.
Anthony Petrone:
Appreciate that. And just a follow-up on Urolift, when you sort of think about the potential that perhaps maybe the market froze here a bit ahead of the reimbursement announcement, do you think any of that was at play in 3Q, or was the bulk of the headwind here really just a deferral of procedures through the Delta? And so as you mentioned earlier, the high – there’s a high probability that these are recaptured over the next couple of quarters. Thanks, again.
Liam Kelly:
I would say, we have very high degree of confidence, Anthony, it has nothing to do with CMS. The CMS ruling won’t come in until next year, if and it hasn’t even been announced. So it is all about COVID.
Operator:
Our next question comes from Jayson Bedford from Raymond James. Your line is open.
Jayson Bedford:
Hi, good morning. Just a couple of UroLift questions, not to get too granular, but is there something different about the geographic makeup for your UroLift business that made it more exposed to Delta meaning, are you over indexed to Florida and Texas?
Liam Kelly:
Yes. So I think that we have very strong presence in Florida and Texas are two of our key markets for UroLift for sure. And you also have to look at in particular in Florida, the population it’s a big retirement community there. So the age profile of men in that area would obviously make it a significant market for us. I think that the main impact of Jayson of the – in UroLift in the quarter is simply the Delta variant. It’s simply 28 states have imposed restrictions. Now we would have thought that as we went through September, we would have anticipate some of those states reducing the restrictions, and we would have expected them this month October that, that they would have also been removing restrictions. And as I said earlier, it is a very deferrable procedure. I personally know two people that need the UroLift and neither of them are willing to have it done in this COVID environment. They’re waiting until the environment improves. So I think that’s the simple impact. And I think the word deferred is the important word, because it is simply deferred. Those two people that I know personally are going to get the procedure done. It will happen if it doesn’t happen in Q4, it will happen in Q1.
Jayson Bedford:
Okay. Okay. That’s helpful. Just as a bit of a related follow-up durable growth is obviously a focus for the team here. I think the debate will turn to the level of durable growth with this business – market has changed, but you did mention normalized growth if you…
Liam Kelly:
Deal with the your reference that durable growth and let’s refer next two minutes, we grew 10.3% earnings per share growth in the third quarter. And as you move into the fourth quarter, I’m going to compare ourselves back to 2019, because that’s a better base year for me. We’re – we grew 6% – in the midst of COVID, the advantage of a diversified portfolio is allowing us to pose real positive growth with real half the earnings are as a result of that. Regarding your question on the durable, what is durable growth for UroLift, obviously, we’re going to give guidance when we get through the fourth quarter. I want to see how the fourth quarter plays out. I am keeping an eye on this new variance that has raised a test in the UK and in Israel. I would want to make sure that that doesn’t become an issue and become Delta part two, as we go through the fourth quarter. But I agree with you, the end markets haven’t changed. Our strength of our position in those end markets haven’t changed and the clinical outcomes of the…
Operator:
Our next question comes from Matt O’Brien from Piper Sandler. Your line is open.
Drew Stafford:
Yes. Hi guys, this is Drew on for Matt, and thank you for taking the questions. I do just want to ask about UroLift and DTC a little bit here. I mean in your deck, you expect or you mentioned that you expected double your impressions in 2020, here in 2021. But your revenues are obviously like that pays significantly and obviously, I think it’s obvious that COVID plays a big part in that. But you just have a sense for where those patients are currently going today. Are they getting into the doctor’s office and being seen, but the procedure they’re being deferred due to COVID or are they facing logistical issue even getting to that point.
Liam Kelly:
Thank you. So we know for a fact that they’re going to the doctor’s office, we know that because we actually direct them to the doctors. So they’re under the care of that doctor now. Again, the impact is simply COVID. You’ve got restrictions in 28 states. You’ve got people that are not comfortable quite frankly going in to have a procedure. And that, that is the impact. One data point that I think is important for investors to realize is the vast number of our champions are in the office and the ASC. And the vast, vast majority of those only offer one minimally invasive modality for the treatment of BPH and that’s UroLift. So by investing behind DTC and by transferring patients to those doctors with the best clinical output, those doctors in the vast majority only offer UroLift. So that’s why we have a heightened degree of confidence in continuing with our DTC. And I would just like to point out that our expectation for impressions with the investment we’re making is 150%. And through three quarters of the year, we are well on track to achieve that level of impression. So we’re very encouraged by the DTC, we’re in burning calories by an engagement, and it was also nice to get the bronze award for the advertisement itself.
Drew Stafford:
Helpful, thank you. And then just to kind of follow-up on that point a little bit just on the competitive landscape, Boston talking about good progress with resume Olympus rolling out good productive space. I know you said that share has been stable, but just wondering if your reps are bumping up against any of these other products in this space and any sense for if your customers are taking a look at some of the newer products. Thank you.
Liam Kelly:
So I would read those comments closely, because they combined two products in the comment. And as we analyze the data, we know that we’re not losing share. It’s not a question of, if we know that we’re not losing share. If you look at the claims data, it shows the market share to steady, and UroLift is holding its dominant position with the minimally invasive treatment of BPH. So this is a COVID question, not a competitive question in my mind.
Operator:
Our next question comes from Matthew Mishan from KeyBanc. Your line is open.
Matthew Mishan:
Hey, great. Good morning, guys. I wondering source the conversation over to the margin side, gross and operating margins. I think, Tom, you laid out, I mean, mostly a miracle locked in freight contracts, like the last December regulations on doing that. But they’re actually running – they’re – those are kind of – those are done at this point. How should we think about the headwind into the fourth quarter and really into 2022 of that excess freight and logistics, as well as sort of lagging costs of materials that end up getting into your numbers as you kind of move forward?
Thomas Powell:
Well, I would say that, as a result of locking in the contracts, we were able to save considerable expense during 2021. As mentioned a number of those contracts did expire at the end of September and others at the end of December. So we do have some heightened inflation in the fourth quarter I cited $3 million overall. The majority of that is really due to the increase in freight both from the expiration of the sea freight contracts, as well as just heightened inflation overall logistics. And that will play into 2022, in terms of inflation as we’re looking at things right now, assuming expenses stay or rates stay where they are, we’re going to see some heightened inflation throughout 2022 on the freight line. Obviously, we’ll get into more detail on that as we provide guidance for the year. And we have greater clarity as to how the rates seem to be trending and whether we expect some recovery or not next year.
Matthew Mishan:
Okay, excellent. And then on the Japan reimbursement for UroLift, with you now scheduled to the meeting in November, were you scheduled previously for it in September, and then it didn’t take it up or they took it off a bit. We’ll move it to November. What’s the logistics of why it was delayed by next couple of months?
Thomas Powell:
No, it’s not a live a couple of months. It’s a – they write out to companies and give them their, their time they’re going to review it. We got ours then it was November in all transparency. We tell it, it was going to be October, but it was November. And we’re really happy that they’re going to review it. Then, it’s a $2 billion mark. It’s a great opportunity for us. We’ve already done the pre-market work and in the marketplace and we expect to ramp as we go through 2022. And we didn’t anticipate any revenue in the fourth quarter in our original guidance to saw. We feel really encouraged and also we feel encouraged by Brazil. We’re early into Brazil, much earlier than we thought. And we think that’s going to be a nice market for us to, we’ve already done a limited market launch. We’ve been down there, we’ve actually trained some surgeons. We’ve got proctors already trained within the region. And we feel really good about both Japan and UroLift. And we feel very good about the international expansion of UroLift under the global marketplace, which is as big an opportunity as the U.S. market once we started to ramp oversee.
Matthew Mishan:
Thanks, Tom.
Operator:
Your next question comes from Michael Matson from Needham & Company. Your line is open.
Michael Matson:
Yes, thanks. Just want to follow up on the prior question on inflation. You’re one of the few MedTech companies that’s really able to get positive pricing, historically. Do you think you could maybe offset some of the inflation with additional price increases or shipping surcharges or anything like that if you needed to?
Liam Kelly:
Mike, thanks for the question. In a word, yes. We’ve seen positive pricing through the first three quarters of the year. We – I agree with you. We’re one of the few companies that he’s able to take positive pricing. We’ve taken some this year in order offset some of the inflation that we’ve seen. And if you look at our margin progress today, it’s reflected in that. You can see, how well we’re doing from a margin in an inflationary environment. As we get to next year, we’ll get to next year, but it wouldn’t be our thinking that we would offset some of the inflation with price increases. Shipping charges are harder to implement, people don’t like them, you’re better off in my view, just looking at it as a straightforward price increase.
Michael Matson:
Okay. Got it. And then just wanted to ask about EZPlaz, I think, the last time you talked about, you said you thought you could have an approval by the end of this year. Is that rain and is that still your thinking on it.
Liam Kelly:
Unfortunately, it’s out of my control right now, because it’s with the FDA. We’ve got our submission in to continue to engage with them. It’s unchartered waters by the FDA. This is a – they’ve never approved a biologic like this before, but they’re -- they continue to engage with as they continued to be helpful. And obviously, we’ll update the investment community, Mike, as soon as we’ve used on it.
Operator:
Thank you. There is no further question at this time. I would now like to turn the call over back to Larry.
Lawrence Keusch:
Thank you, operator, and thank you to everyone that joined us on the call today. This concludes the Teleflex incorporated third quarter of 2021 earnings conference call.
Operator:
This is currently all the time we have for questions this morning. And this concludes our conference call. Thank you for participation.
Operator:
Good morning, ladies and gentlemen, and welcome to the Teleflex Second Quarter of 2021 Earnings Conference Call. At this time, all participants have been placed in a listen-only mode. At the end of the company’s prepared remarks, we will conduct a question-and-answer session. Please note that this conference is being recorded and will be available to the company’s website replay shortly. And now, I would like now like to turn the call over to Mr. Lawrence Keusch, Vice President of Investor Relations and Strategy Development Team. You may begin, sir.
Lawrence Keusch:
Thank you, Dexter. Good morning, everyone, and welcome to the Teleflex Incorporated second quarter 2021 earnings conference call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing 800-585-8367, or for international calls, 416-621-4642, with the passcode 5188749. Participating on today’s call are Liam Kelly, Chairman, President and Chief Executive Officer, and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks and then we will open the call to Q&A. Before we begin, I’d like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K which can be accessed on our Web site. In addition, please note that, while we have provided commentary about intra-quarter business performance during the recent earnings calls to provide additional details and insights around trends, we do not intend to provide such commentary on today's call or in connection with future earnings calls. With that said, I'll now turn the call over to Liam for his remarks.
Liam Kelly:
Thank you, Larry, and good morning, everyone. It's a pleasure to speak with you today. We are delighted with our second quarter performance, which exceeded the outlook we provided on the first quarter earnings call, reflecting the company's resilient base business and innovative growth drivers, offset by varying degrees of COVID-19 challenges on a global basis. The majority of our global product families witnessed constant currency growth over the second quarter of 2019. As anticipated, we witnessed improvements in underlying utilization trends for the product categories most impacted by the postponement of non-emergent procedures, most notably interventional urology, interventional and surgical. We are encouraged with UroLift as momentum continues to build, driving 26% constant currency revenue growth as compared to the first quarter of 2021. During the second quarter, our Americas, Asia, and OEM segments performed well, with constant currency revenues growing over 2019, while EMEA is now back to 2019 revenue levels. As we anticipated, Americas and Asia continue to recover more quickly than EMEA. Although uncertainties with COVID-19 remain, we continue to anticipate that our revenue performance will improve as we move through the remainder of 2021. For the second quarter, operating margin showed gains over 2020 and 2019 in comparable periods and was driven by gross margin and disciplined expense control. Our continued progress in margin expansion in 2021 has allowed us to increase directed investments towards growth drivers, which is an important component of our long-term strategy to enhance durable growth. Given the strength of the second quarter results, we are maintaining our constant currency revenue guidance, which now includes a $28 million to $32 million sales headwind from the June 28 initial close of the respiratory products divestiture that was not included in our prior guidance. Based on our outlook for the second half of 2021 and our margin improvement in the second quarter, we are increasing our 2021 earnings per share guidance to a range of $12.90 to $13.10 from our previous guidance of $12.65 to $12.85. We continue to execute on our strategy to drive durable growth with investment in organic growth opportunities, margin expansion and deployment of capital for M&A. Turning now to a more detailed review of our second quarter results. Second quarter revenue was $713.5 million, an increase of 21% year-over-year on a constant currency basis and 6.8% over the comparable period in 2019. The year-over-year increase was driven by contributions from interventional, anesthesia, surgical, and interventional urology, offset by unfavorable year-over-year comparisons due to higher demand for our vascular access and respiratory products in quarter two 2020 associated with COVID-19. We are also pleased with our second quarter gross and operating margins with sequential improvements over Q1 strong performance. Q2 adjusted and operating margins set new high watermarks for Teleflex at a pure-play medical device company, an encouraging sign for our longer-term profitability objectives. Second quarter adjusted earnings per share of $3.35 increased 73.6% and exceeded our internal expectations. The earnings outperformance reflects the recovery in health care utilization during the second quarter, coupled with improved volume, modest price increases, and prudent operating expense management. Overall, I am very happy with our second quarter financial performance, which demonstrates the importance of our diversified global product portfolio, while also reflecting progress towards our longer-term margin aspirations. Turning now to a deeper look at revenue results. I will begin with a review of our reportable segment revenues. And unless otherwise noted, the growth rates I will refer to are on a constant currency basis. Americas revenues were $414.8 million in the second quarter, which represents 31.8% growth year-over-year and 10.8% over the comparable period in 2019. Growth was driven by a rebound in procedures following the disruption of COVID earlier in the year, with particular strength in interventional urology, surgical and interventional. EMEA revenues of $157.1 million increased 8.4% year-over-year and was flat over 2019 levels. EMEA benefited from a favorable COVID-related comparison as procedures improved year-over-year as countries across the region continued to open up. Turning to Asia. Revenues were $80.6 million, increasing 10.3% year-over-year and consistent with the performance seen in the first quarter of 2021. Asia was up 1.7% as compared to 2019. Importantly, we saw solid double-digit growth in China and high single-digit growth in Japan, more than offsetting declines in Southeast Asia. And lastly, our OEM business, which accounts for roughly 9% of total sales, increased 6.9% year-over-year to $61 million in the second quarter. OEM was up 6.5% as compared to the comparable period in 2019. Following a 17.1% decline in the first quarter of 2021, the business witnessed a rebound as customers stepped up orders on signs of increasing healthcare utilization. We continue to expect a sequential improvement in growth through the second half of 2021, driven in part by incremental capacity. Let’s now move to a discussion of our second quarter revenues by global product category. Consistent with my prior comments regarding our reportable segments, commentary on global product category growth will also be on a constant currency basis. As a reminder, there were no meaningful differences in year-over-year selling days in the second quarter. Starting with vascular access. Second quarter revenues decreased by 2.1% to $167.7 million. Although we are facing difficult year-over-year comparisons in vascular access due to the higher demand experienced in quarter two 2020 associated with COVID-19, the performance of our innovative products remained strong. Our PICC portfolio performed well, with over 30% growth year-over-year. We continue to invest behind our differentiated PICC portfolio and continue to take share. Intraosseous was also strong in the second quarter, with growth of 15.5% year-over-year. Moving to interventional. Second quarter revenue was $112.1 million, which rose 30.9% year-over-year. The increase was due to a recovery in certain non-emergent procedures on a year-over-year basis. MANTA, our unique large bore closure device, grew 160% year-over-year, which keeps us well positioned to reach 8% share in 2021 out of a $200 million to $300 million market opportunity. Turning now to anesthesia. Second quarter revenue was $95.4 million, up 38.8% year-over-year. Z-Medica contributed roughly 60% of the growth as the business continues to track to our $60 million to $70 million revenue expectation for 2021, partly offset by lower sales of tracheostomy products. Excluding FX and the Z-Medica acquisition, underlying growth for anesthesia in the second quarter was approximately 16% year-over-year. The integration of Z-Medica is going very well, and we are pleased with the progress we are making. In our surgical business, revenue was $98.2 million, representing 39% growth year-over-year. The increase in revenues was driven by sales of our metal and polymer ligation clips and instruments as elective surgical procedures continued to recover. For interventional urology, second quarter revenue was $92.2 million, an increase of 129.4% year-over-year and 35.6% over the second quarter of 2019, reflecting a move back towards more normalized growth. We are encouraged by the business trends, with physicians remaining engaged in the use of UroLift in all care settings and patients increasingly seeking treatment for symptoms of BPH. Our DTC momentum remains solid, and we remain comfortable in our 30%-plus revenue growth objective for UroLift in 2021. And finally, our other category, which consists of our respiratory and urology care products, declined by 9.9% to $86.9 million. The decline reflects difficult comparisons from the prior year related to COVID-associated respiratory product demand in Americas and the EMEA. That completes my comments on second quarter revenue performance. Turning to some clinical and commercial updates. In the second quarter, we trained 118 urologists and remain on track to achieve our target to train 450 to 500 urologists in 2021. We continue to execute on our 2021 DTC program. For this year's campaign, we are optimizing our network selection, refreshing the ads and working in conjunction with social media campaigns to augment the overall impact. Given the positive awareness from the DTC campaign, we have decided to make incremental investment in the second half of 2021 to tap into this underpenetrated market. We view DTC as a multi-year catalyst for UroLift in the US, as we are still in the very early innings of market adoption and patient awareness. Indeed, UroLift is leading the way in minimally invasive treatment of BPH and this is the first time in recent years that a BPH brand is reaching patients directly in a meaningful way. Turning now to UroLift 2, we are in a full rollout in the US, which is consistent with our timing expectations. We continue to anticipate that the vast majority of physician customers will be converted to UroLift 2 by the end of 2022, paced by advantages in visualization, reduced storage space and increased manufacturing capacity. We remain positioned to generate significant margin expansion as the revenue base is fully converted. Regarding Japan, we remain on track for reimbursement decision in 2021 and view the approximate $2 billion addressable market as an incremental growth driver that will be a positive catalyst for the foreseeable future. Our submission was not reviewed at the July MHLW meeting and we now expect a review in September with a launch in the fourth quarter of 2021. There is no change to our expectation for UroLift revenues in Japan to ramp up beginning in 2022 with modest contribution in 2021. On the US reimbursement front, CMS published its proposed physician fee schedule for calendar 2022 on July 13. The proposed reimbursement rate for UroLift in the physician office setting were reduced by 19% to 21% year-over-year. A couple of points I want to make. First, the proposed payment reductions to office-based procedures would not go into effect until January 1, 2022 and, therefore, do not impact our 2021 outlook. Second, the proposed reductions were broad-based across a range of office-based procedures in a variety of surgical specialties and not specific to UroLift. Third, we continue to view the strength of our clinical data, including the L.I.F.T. pivotal trial and real-world studies, as a differentiator versus other BPH treatment modalities and a driver of UroLift adoption. On next steps, Teleflex will engage with key stakeholders during the public comment period to reiterate the benefit of UroLift for the treatment of BPH. We would hope that CMS recognizes the importance of maintaining patient access to safe, effective and less invasive procedures, including UroLift, in lower-cost settings such as the physician's office. We anticipate the final rules will be published during the fourth quarter of 2021. Separately, CMS published the proposed outpatient prospective payment system rates on July 19. These rates cover facility payments for UroLift in the hospital outpatient and ASC settings. In this case, the proposed payments for UroLift increased by 3% approximately for 2022 versus 2021. Investors familiar with Teleflex will know that approximately two-thirds of UroLift revenues are generated in the ASC and outpatient settings. Turning to the next slide on a clinical update for UroLift. On July 9, the largest US Medicare and commercial claims analysis of four BPH procedures was presented at the European Association of Urology Meeting. The study, which included reimbursement claims from 2015 to 2019, evaluated surgical retreatment and post-operative complications endured by patients who underwent TURP, GreenLight laser, Rezum, and UroLift procedures. At four years after the index procedure, surgical retreatment rates were comparable for UroLift, TURP, and GreenLight laser, and highest for Rezum. Also, at 300 days post-treatment, overall complication rates were lowest after UroLift, while Rezum had the highest rates. These statistically significant results demonstrate the efficacy of UroLift as compared to other therapies for the treatment of BPH in real-world settings. We will continue to bolster our body of clinical evidence, which should help to sustain UroLift as the leading minimally invasive procedure to treat BPH and address a multibillion-dollar global market opportunity. Now, I will provide some background on the respiratory divestiture. Consistent with our strategy to drive durable growth and disciplined portfolio review process, we completed the initial phase of the divestiture of a significant portion of our respiratory products to Medline Industries on June 28. The transaction generated $286 million in cash, less $12 million in working capital not transferred to Medline. As noted previously, the product lines that were divested generated $139 million in revenues in 2020. Looking forward, the divestiture of the respiratory assets will improve our organic growth rate and margins over time and better positions us for internal resource allocation and a focus on our key growth drivers. That completes my prepared remarks. Now, I would like to turn the call over to Tom for a more detailed review of our second quarter financial results. Tom?
Thomas Powell:
Thanks, Liam. And good morning, everyone. Given the previous discussion of the company's revenue performance, I'll begin at the gross profit line. For the second quarter, adjusted gross margin totaled 59.9%, an increase of 600 basis points versus the prior-year period. The increase in gross margin was driven by product and regional mix, benefits from cost improvement initiatives, favorable impacts from pricing, M&A and foreign exchange, partly offset by logistics and distribution expense. Second quarter adjusted operating margin was 28.2% or a 640-basis-point year-over-year increase, driven largely by the gross margin improvement as well as disciplined expense management, and partially offset by investment in the business. With our revenue base improving and operational efficiencies, we delivered a more typical one-to-one drop through from gross margin to operating margin during the second quarter For the quarter, net interest expense totaled $15.9 million, an increase from $15.5 million in the prior-year period. As previously mentioned, in the second quarter, we issued a notice of redemption to holders of our outstanding $400 million aggregate principal amount of 4.875% senior notes due in 2026. The notes were redeemed on June 1, 2021, and was funded using borrowings under our revolving credit agreement and cash on hand. Our adjusted tax rate for the second quarter of 2021 was 14.4% as compared to 15.8% in the prior-year period. The year-over-year decrease in our adjusted tax rate is primarily due to geographic mix shift of profits and a larger benefit from stock-based compensation as compared to the prior-year period. At the bottom line, second quarter adjusted earnings per share increased 73.6% to $3.35. Included in this result is an estimated favorable impact from foreign exchange of approximately $0.16. Turning now to select balance sheet and cash flow highlights. For the first half of 2021, cash flow from operations totaled $265 million as compared to $134 million in the prior-year period and represented a year-over-year increase of $131 million. The increase was primarily attributable to favorable operating results, lower contingent consideration payments and lower payroll and benefit related payments, partially offset by unfavorable changes in working capital and higher tax payments. Overall, the balance sheet remains in good shape. At the end of the second quarter, our cash balance was $361.8 million versus $375.9 million at the end of the fourth quarter of 2020. We paid down $75 million in debt during the second quarter and net leverage at quarter-end was approximately 2.5 times. Post-quarter close, we made a $259 million payment against our revolving credit facility using funds primarily generated from the initial close of the respiratory business divestiture. Now, moving on to 2021 guidance. Starting with revenue, we are maintaining our constant currency revenue growth guidance for 2021 of between 8.5% and 9.75% year-over-year. Of note, the strength in the second quarter sales results have allowed us to offset the $28 million to $32 million revenue headwind in the back half of the year associated with the respiratory divestiture, which was not contemplated in our prior guidance. As you contemplate your model adjustments, know that the divested respiratory products are in our other revenue category. And please see the investor slide deck for historic revenues for the divested respiratory products. Key contributors to our 2021 constant currency revenue growth outlook are expected to be interventional urology, interventional, surgical, and anesthesia product offerings. For interventional urology, there is no change to our expectations for at least 30% growth in 2021. We continue to expect the acquisition of Z-Medica to add $60 million to $70 million in sales in 2021. Turning to currency, we expect foreign exchange rates will be a tailwind to reported revenue growth of approximately 2%. As a result, we continue to expect our as-reported revenue to increase between 10.5% and 11.75% over 2020. And this would equate to a dollar range of between $2.804 billion and $2.835 billion. Now for some commentary on our margin outlook. We are increasing our adjusted gross margin guidance for 2021 to a range of between 59.25% and 59.75%, representing a raise from the prior guidance of 100 basis points at the low end and 50 basis points at the high end. We expect gross margin expansion to be driven primarily by a favorable mix of high margin products, including interventional urology, interventional access and surgical, as well for manufacturing productivity improvement programs and benefits from previously announced footprint restructuring programs, partially offset by inflation. There is no change to our expectation that the acquisition of Z-Medica will add approximately 50 basis points to gross margin for 2021. For adjusted operating margin, we are increasing our 2021 guidance to a range of between 26.75% and 27.50%, representing a raise from the prior guidance of 75 basis points at the low end and 50 basis points at the high end. The increase in adjusted operating margin will largely come from the gross margin line and leverage, partially offset by the expected increase in spending in the second half of 2021 as we progress towards a more normalized environment, as well as incremental strategic investments in UroLift and MANTA. Moving down the P&L, we now expect interest expense to be in the range of $60 million to $62 million for 2021 versus our previous guidance of $61 million to $63 million. The decrease in interest expense largely reflects the reduction in debt funded by proceeds from the respiratory divestiture. On taxes, we continue to expect our adjusted tax rate will be in the range of 13% and 13.5%. Considering all these elements, we are raising our adjusted EPS outlook for 2021 to a range of $12.90 to $13.10. That represents a 20.9% to 22.8% year-over-year increase. We are pleased to be able to increase our earnings per share guidance by $0.25, while also covering the $0.10 to $0.15 of EPS dilution from the respiratory divestiture. That was not reflected in our prior outlook. And that concludes my prepared remarks. I would now like to turn the call back to Liam for closing commentary. Liam?
Liam Kelly:
Thank you, Tom. In closing, I will highlight our three key takeaways from the quarter. First, we delivered a strong second quarter, with top and bottom line performance that outpaced our expectations laid out on the Q1 call. Second, we remain encouraged by our growth trajectory, with the majority of our global product families posting constant currency growth over the second quarter of 2019. Third, we maintained our revenue outlook and raised our adjusted margin and earnings per share guidance for 2021 despite headwinds associated with the respiratory divestiture that was not contemplated in our prior guidance. In closing, we feel good about our solid performance in the quarter and our future growth opportunities. When considering the early third quarter close of the respiratory divestiture, our leverage reached 2.3 times, which places us in a positive position with respect to flexibility on our balance sheet. We will continue meeting our commitments to patients, clinicians, communities, and, of course, our shareholders. That concludes my prepared remarks. Now, I would like to turn the call back to the operator for Q&A.
Operator:
Operator
Matthew Taylor:
Hi. Good morning. Thank you for taking the question. The first thing I just wanted to ask you about the UroLift trends that you're seeing, if you could describe any trends during the quarter, and then just talk about your confidence to reiterate the guidance for UroLift through the year. Any color on the cadence that we should expect for the rest of the year?
Liam Kelly:
All right, Matt. Absolutely. And thanks for the question. Now, Matt, we are not going to get into intra-quarter details on this quarter, as Larry outlined in his opening comments. But I will tell you that, first of all, we're really pleased with what we saw in UroLift in Q2. We are positively reaffirming our growth expectations of plus 30% for UroLift. And we are really pleased with the growth in the quarter of nearly 130% and sequentially quarter-over-quarter plus 26%. Investors familiar with UroLift will recall that UroLift grew around 30% days adjusted in Q1 versus 2019. And in Q2, that growth versus 2019 actually accelerated to around 36%. And we continue to expect that total dollar revenues for UroLift to continue to improve in Q3 over Q2 and again in Q4 over Q3. So, a good positive message on UroLift, Matt.
Matthew Taylor:
Thanks, Liam. And could you just comment on your overall thoughts on the reimbursement change and talk about your efforts there to get a different outcome in the final rule? And what would happen, I guess, if the worst-case scenario sticks and you do have these cuts in the office?
Liam Kelly:
So, to be honest, Matt, we're looking forward to engaging with CMS to better understand what their objective was in making such broad-based reductions to over 600 surgical procedures that are performed in the office setting. It will be our goal to demonstrate both the excellent clinical data that supports UroLift and the healthcare economics data, which is also very compelling. I am sure they will be attentive to the potential unintended consequence of some procedures being moved to higher cost of care settings. We believe that the timing of this change, as it is being proposed, may be ill-advised at a time when most government bodies are trying to promote procedural return post-COVID, and they're promoting that return to lower cost settings where the patient also views that lower cost setting as being a less risk setting of contracting COVID. So, our plan is to engage with the key stakeholders, including other device industry, trade groups, physician associations, and patient advocacy groups. I think our strategy will depend on the final ruling, Matt, as to what decisions that we will take and moving forward. And we believe that CMS will listen, given that there is such a broad comments going to land in regard to this particular ruling.
Operator:
Next question [Technical Difficulty] Morgan Stanley. Your line is open.
Cecilia Furlong:
Hi. Good morning. And thank you for taking the questions. Liam, I wanted to continue with UroLift. But just curious, could you talk about just the users trained on UroLift during COVID, what you've seen from recent contributions as well as any trends in UroLift site of service? And then also, just what you're expecting from DTC contributions in the back half of this year?
Liam Kelly:
Yes. So, thanks, Cecil. So, regarding site of service, about 30% of procedures have traditionally been done in the office, with the remainder done outside of the office in the ASC and the hospital. As we went through COVID, which was the other part of your question, we saw a slight increase in office procedures. And as we come out the other side of COVID, we see that normalizing again and getting back to that more normalized level. With regard to the DTC, Cecil, we're really encouraged by the performance of DTC, so much so that we've actually increased the investment in it in the back half of the year. We had anticipated that we would have about 125% of the impressions in 2021 versus 2020. With this increased investment, now we would think that would be 150% plus the number of impressions that we're going to gain. I was actually – spent a week on the road with the sales team meeting urologists. And I met over 20 urologists. And this is only anecdotal and I get that. But all bar one urologist was able to tell me that they've had people turn up into their practice, whether it be a hospital, ASC or an office, referring to the ad that they saw on television or that hit them on Facebook, and asking the urologist about UroLift based on that. So, that is very encouraging. And we continue to see it as an excellent return on our investment, and therefore, we're spending additional dollars in the back half of the year.
Cecilia Furlong:
Great. Thank you. And then, just on gross margins as well. For the second half, could you comment on what is implied for either UroLift 2 conversion or OEM contributions as well as geographic mix? Thank you.
Liam Kelly:
So, I'll just touch on the UroLift and then I'll ask Tom to comment. So, we anticipate the UL2 conversion being completed by the end of 2022. We're in full ramp now as we go towards the back end of the year. I'm pleased to confirm that we still anticipate that we will pick up a full 4 percentage points of margin from that conversion to the UL2. And therefore, that would add about 40 basis points to the total of Teleflex. So, you'll begin to see some of the conversion as we go through the back end of the year, Cecil, but you'll see the majority of it come through in 2022. And Tom might answer some of the cadence of gross margins, if you don't mind, Tom.
Thomas Powell:
Sure. Well, I think there's some question about OEM in other geographies. So, as we look at the OEM business, we had a soft first quarter with a nice recovery in the second quarter. So, we really saw improving trends there as customers began seeing improvements in procedures and began ordering again. And we expect that to continue through the balance of the year. Then in terms of the various geographies, as we've said all along, our expectation was that the North American region would recover first or the Americas would recover first, followed by Asia and EMEA. And that's still kind of playing out as expected. So, we expect all regions to continue to show improvement in the back half of the year relative to the first, but perhaps the Americas a little bit stronger than some of the others. And then, in terms of the overall gross margin, I'd say that, overall, we're really encouraged by what we've seen in the first half of the year, allowing us to take the guidance up. At the upper end of the guidance range, we're at 59.75%, which is slightly ahead of where we were for the first half of the year. So, we are really encouraged by what we're seeing and we're cautiously optimistic about the back half.
Operator:
And we have a question from Shagun Singh with Wells Fargo. Your line is open.
Shagun Singh-Chadha:
Great. Thank you so much for taking the question. I guess the first one is on UroLift reimbursement. Could you talk about the potential phase-in of the office rates? It does appear that changes to the labor codes may go into effect, but it may be phased in over a four-year period. Firstly, is that your expectation? And secondly, what impact do you expect this to have on procedures in the office setting and your ability to move them to more profitable settings over time? And then, even with respect to physician payment cuts in the HOPD and ASC setting, I believe it's about 6% in addition to the cuts in the office setting. What impact do you expect that to have on utilization in those settings? And then, I have a follow-up.
Liam Kelly:
Okay, Shagun. So, we're really focused on what we can control right now. So, we're expecting that we'll spend a lot of time working with the key stakeholders in this comments period. I don't want to start second guessing the results, to be honest, Shagun, because depending on the outcome of the final ruling, that would depend on one strategy. We're going to continue to work with CMS, some of our industry body patient advocates organizations. And obviously, there are clinicians themselves putting through comments to CMS in regards to this reimbursement. With regard to the site of service, there is a certain amount of flexibility there for physicians, and many of the urologists would have – part of their workload would be in an office environment, part in an ASC and it's not uncommon for even part to be in a hospital. So, that does give the physician a certain amount of flexibility. I believe that CMS will be open to the comments period, and I believe that they will listen to what all of these individuals have to say with regards to this. With regard to the ASC and the hospital reimbursement, we're very encouraged by that. Overall, it's a 3% increase. Again, this will come into effect on January of 2022, Shagun. So, absolutely no impact on anybody until the end of the year. And again, it was broad based. So, there are 600 procedures that are impacted by this, Shagun. So, you can imagine there's going to be a significant amount of comments during that comment period. And you had a second question, Shagun, I believe.
Shagun Singh-Chadha:
Yes. So, thank you for that. So, just with respect to Q3 and the second half of 2021, I was just wondering if you could talk us through the cadence. It does appear that Q3 sales are typically below Q2 levels and EPS is just modestly up. So, what are your thoughts on where consensus currently stands, especially with respect to UroLift? I think last I checked, consensus was looking for about $105 million. Thank you.
Liam Kelly:
Yeah. So, things are kind of playing out as we expected, Shagun. The recovery is being led by the Americas, and Asia and Europe are lagging. So, I'll start with overall Teleflex. So, look, the COVID has not gone away and we're monitoring the situation very closely. And I, for what it’s worth, will add my voice of encouragement for people to please get vaccinated. The key here is getting people vaccinated because the second or third or fourth wave, whatever we're on now, is not impacting those that are vaccinated and not impacting geographies where people have vaccinated. So, we remain cautiously optimistic and we're very encouraged by the trends that we saw from Q1 to Q2 and we expect the stability of Q2 to continue. And that has given us the confidence to maintain our full-year revenue guidance despite the respiratory divesture headwinds. In any other language, that would be seen as a call-up between $28 million and $32 million on the revenue and obviously a significant call-up on our EPS as well. So, overall, Teleflex, what I expect is our growth to accelerate in the back half of the year versus the first half. We grew 8.6% constant currency in the first half of the year. If you take the midpoint of our revenue guidance range, inclusive of the 1.6% divestiture headwind, that would imply acceleration in the second half to 9.6% inclusive of that. If you exclude the divestiture headwind, it's about 11.2% in the back half versus the 8.6%. So, full year, we have effectively, as I said, raised our revenue guidance and that strong EPS. And this is the second quarter, again, as investors will know, that we have raised both our revenue and EPS. With regard to UroLift, as I said a few moments ago, I expect the absolute dollar values of UroLift to increase in Q3 versus Q2 and again in Q4 versus Q3 in that regard. So, thank you for the questions, Shagun.
Operator:
We have a question from Matthew O'Brien with Piper Sandler. Your line is open.
Matthew O'Brien:
Morning. Thanks for taking the questions. And I’m going to stick on UroLift as well, so forgive all the questions here. But, Liam, there is a proposal for down roughly 20% in the physician's office that you talked about. If it ends up being down 10% in the final rule, would you have to cut your price and by how much in that setting? And then, do you think clinicians would start to deploy less staples per case if that were the situation?
Liam Kelly:
So it would have no impact on the number of staples, Matt, because there’s two codes, one is four for staples and the other then is for all the additional staples thereafter. So, it wouldn't – and it's – the cuts have been defined across the board on all of the different categories. I think that we will assess what we will do once we get the final ruling. Obviously, a 10% reduction is a lot less draconian than a 20% reduction. But one would imagine that common sense will prevail. If you look at what CMS did in the prior ruling, they added a COVID impact of about 3.5%. And speaking with the members of the key associations, their expectation was that that would be removed in this ruling and nothing more than that. So, we'll see how it plays out. But I don't see it having a significant impact or us having to make all – any changes to our overall pricing structure because we have strength in all care settings in the ASC, in the office, in the hospital and in all of those areas. So, we probably have an advantage, with a certain amount of flexibility, Matt, that other companies don't.
Matthew O'Brien:
Got it. Very helpful. And then the follow-up is on the competitive side of things. I would just love to get your view on surgical robots for BPH and the pros and cons of that. Is that an area that you think you need to eventually have a presence in?
Liam Kelly:
Yeah. There's one out there. There’s the PROCEPT robot out there, Matt. It is getting some utilization. Robots are seen as being somewhat sexy right now, but it's really treating TURP. And what we hear in the feedback is it requires a secondary procedure because it doesn't use heat. It actually uses a jet of water. And when you use water, it doesn't coagulate because you don't have any heat to stop the bleeding. So, therefore, it requires a second procedure by the surgeon to go in afterwards and stop the bleeding. And in a recent podium speech, that was raised by a number of urologists. And in their pivotal trial, there were a number of patients that had to have blood transfusions where there were issues with excessive bleeding. So, I think it's – I don't see it as really a treatment for BPH or the technology that's going to impact on UroLift. And our clinical data is rock solid. Ours is a minimally invasive procedure, no catheter, no sexual dysfunction. And we have a large, large bolus of trained physicians that are rolling out UroLift. So, we’re aware of it, Matt. But I don't see it as a need for us to get into robotics would be the direct answer to your question.
Matthew O'Brien:
Great. Thank you very much.
Liam Kelly:
Thanks, Matt.
Operator:
[Technical Difficulty] is open.
Unidentified Participant:
Yeah. Thanks for taking my questions. I have another one on the UroLift reimbursement. So, I think you said around 30% of the procedures were being done in the office setting. So, I guess what I was wondering is, what was the growth in that setting? Is that a bigger contributor to growth or has that kind of been growing in line with the rest of the business?
Liam Kelly:
So, thanks for the question, Mike [ph]. So, it's been growing in line with the rest of the business. During COVID, there was a little bit of a shift to more procedures in the office, but that's the only impact that you should take into consideration, but very much in line with the other sites of service in the business.
Unidentified Participant:
Okay. So it's not like the reimbursement level was creating some significant incentive to do more procedures in that setting or something like that, right?
Liam Kelly:
No, but the UroLift was profitable on all sites of service. And as I said earlier, that's an advantage that we have over almost every other treatment modality. We have flexibility, whereas others don't. And again, it's 30% of the procedures and approximately 70% of those – of that 30%, Mike, is Medicare/Medicaid.
Unidentified Participant:
Okay. Got it. And then my second question would just be on pricing. I don't know if you quantify the pricing benefit, but I guess just stepping back in terms of pricing, just given what's happening in the broader economy with inflation and things like that, you think it's getting any – maybe any easier to get some pricing increases with your products?
Liam Kelly:
So, Mike, I've been doing this a long time, and I can tell you, I can count no hands, no fingers, no toes the amount of times a customer calling me up and ask me for a price increase. So, it's a tough environment always looking for pricing. But as I said on the last earnings call, we got out ahead of this early. We anticipated that there might be some movement in price momentum, and we had about 20 basis points of positive pricing in Q1. That actually accelerated in Q2. We took some additional opportunities in Q2, and we continue to view that very closely. On the other side of the ledger on the inflation side, we feel we have that very much under control within our – in particular, in our global supply chain. Any inflation that we saw, we saw it begin last year in transportation. So, that was already in our run rate. And we saw some modest inflation in some of our resins, but it was pretty – it's very manageable, and we're going to more than offset it with really positive pricing and building momentum in the quarter with that positive pricing.
Unidentified Participant:
Okay. Great. Thanks.
Liam Kelly:
Thanks, Mike.
Operator:
[Technical Difficulty]
Unidentified Participant:
Hi. Great. Thanks. And I want to say congratulations to Larry on the new role with the company. A couple of questions here. One, Liam, is just the overall procedure backlog sort of environment. A lot of chatter on that this earnings season, certainly hard to quantify. But as you look across the portfolios, is there any way to sort of view how much deferred procedure backlog is still out there and perhaps which segments would benefit most into the back end of the year? And I'll have one follow up.
Liam Kelly:
So, Anthony [ph], thank you for acknowledging Larry. We're happy to have him on the Teleflex ship. Regarding the backlog, it's hard for us to quantify it, too, in all transparency. There has to be a backlog of procedures out there because for almost a year, there were very few procedures done. I think that any backlog of procedures will be dependent on site of service and customer confidence in coming back. So, therefore, again, back to the CMS decision that I mentioned, this would not be I think the most appropriate time to make that change that they're talking about because patients themselves see an office or an ASC environment as a much safer place to go and get a procedure done, and it's a lower cost site of service for the person getting them. But I would imagine that there has to be backlog, in particular, in our UroLift business. There has to be a backlog in our surgical business and there has to be a backlog in our interventional business. It's hard for us to map it out. I don't think we've seen much of it yet, Anthony, come through the system because there just isn't that additional capacity in the hospitals and they're probably going to do some of those more acute procedures first. And we're not baking that in, any significant backlog into our thinking in the back half of the year, I can tell you.
Unidentified Participant:
Okay. And then the follow-up would be on UroLift and I'm just going to sneak one in on MANTA. So, on UroLift, can you just level-set on how many procedures your active users are doing on a monthly basis and the average number of implants? We're assuming it's still for 4, 4.5 implants. And then, MANTA, that was a breakout Q. Just some color on, was that new center usage, share gain or just kind of a rebound from backlog? Thanks again.
Liam Kelly:
Yeah. So, I’ll start with the UroLift. So, the UroLift, the average is still about 4.5 implants. And as we recover out of COVID, we're just around that that 4 procedures per average urologist. With regards to MANTA, we continue to see MANTA grow. It had an outstanding quarter. And the areas that we're seeing MANTA procedures come in is still predominantly in that TAVR area, about 84% of them were in TAVR in that quarter, consistent with Q1, about 11% in EVAR and a modest 4-ish-percent in PVAD. So, we continue to train physicians. We're penetrating more accounts. And it is one of the areas, Anthony, that we're going to put some investment in in the back half of the year because we want to actually train more interventionalists and we see this as a future catalyst for Teleflex growth. Good, solid sustainable growth for a company like Teleflex. And you should expect to see us put more feet on the street in doing more additional training and bring more docs on at a faster pace.
Operator:
Next is from Richard Newitter from SVB Leerink. Your line is open.
Richard Newitter:
Hi. Thanks for taking the questions. I just had a couple more here on UroLift. I know it's got a lot of attention, but I think it's important. The first is on price. What are your options, Liam, to price differentiate by care setting, if you had to? Just is there a way to use rebates, where you keep pricing in one setting at one level? And then if you needed to keep the doctor whole, should there be a cut? And then, I have a follow-up.
Liam Kelly:
Yeah, Rich, obviously, we’ll define our pricing strategy once we get the final ruling. But to answer your question, yes, we have flexibility based on site of service and based on the individual contracts that are in existence. So, that flexibility remains with us. As you know, we are not a price reducing company, and never have been, and it is not our intention to be that. It is our expectation that we will maintain our overall average selling price for all of our product categories. But we do have a certain amount of flexibility to answer your question directly.
Richard Newitter:
That's helpful. And then, just maybe two quick ones here. So, on the third quarter commentary, especially with respect to UroLift, but feel free to answer total company as well, if you look at the UroLift ramp, the consensus is at, I think someone mentioned, $103 million, $104 million, a sequential improvement off of $92 million. It leaves a wide range between the possibilities of where consensus is and what that could mean. I think it would be helpful for investors to just give a sense relative to the consensus. Is it just right, maybe a little conservative, a little too aggressive for the ramp? I think any color there would be helpful. And then, while I have you, just on Japan, is there any Japan contribution assumed in that 30% for the back half of the year? What's the definition of modest and how do we think about a year one kind of contribution case for Japan when and if you get approval for reimbursement? Thanks.
Liam Kelly:
So, let me start with Japan, Rich, because I'm not going to comment on consensus. So, on Japan, we have – modest means modest, Rich. We have a very modest amount of dollars in the quarter four number for UroLift. It's a $2 billion market. The only predicate we have for a ramp is what happened in the United States. And think of Japan as about a third of the size of the United States market. And what happened in the US – in the very first year, we did $5 million, then we did $16 million, then we hit $50 million. And once you had built that base of $50 million, then it accelerated to over $100 million, then $200 million and $300 million and so on so forth. Now, Japan has an advantage, in that it's a single payer market. So, once we get reimbursement, we can sell at all sites of service. It is also a conservative market. We've already identified the 20 top key opinion leaders in order to start driving adoption. And the way it works there, it's quite hierarchical. Once you get those key opinion leaders, you get them training and speaking on the podium, then it will start to trickle down to the other urology practice. We will start in the tertiary hospitals, the key thought leaders and build it out from there. And we give a lot more detail on the size of the different markets in Japan and other geographies that we're intending on attacking once we get to our Investor Day later in the year. I will say that we will be in Japan before any of our competitors will get there. We're well ahead of the market in regards to that. And we also believe we'll be in the China market well ahead of any of our following competitors. So, we'll have time to build the market, make this a standard of care. That's also an advantage compared to the US because, as you know, both competing technologies, Rezum and UroLift, were in the market around the same time. Actually, Rezum was probably there just a little bit before. And back to the UroLift, rather than talking about the consensus, I’ll just reiterate what I said earlier, Rich. We expect sequential improvement in absolute dollars in Q3 over Q2 and in Q4 over Q3.
Operator:
[Technical Difficulty]
Unidentified Participant:
Great. Thank you for taking the questions. Hey, Liam, just a bigger picture question, kind of what is your sense of why CMS kind of made these changes specifically to the physician office? And then, just how many – how feasible is it for that 30% of the procedures you're talking about to just switch from a physician office to an ASC setting?
Liam Kelly:
So, I think, Matt, don't ever forget that, first of all, the urologist’s duty of care is to the patient. And they will do the right thing by the patient and give the best procedure to that patient. So, I think the one thing to make note of is that UroLift is a minimally invasive procedure, instant relief, no sexual dysfunction, no side effects, and the patient will not have to wear a catheter in the event that they – once they have the procedure. So, we made it an easy decision for the clinician to actually pick UroLift over any of the technology. And that's why we are the dominant player in the space. With regard to shift site of service, I don't think once we get the – I'm hopeful that once we get the final ruling that that may become a moot point as to shifting site of service from one area to another in that regard. And I think that the motivation behind CMS is difficult for me to ascertain at this stage in all transparency. But we will engage with them. And as we engage with them, we will obviously listen to what they have to say. And that's what I said earlier on. We need to understand what their motivation was because it is not clear to us at this stage what drove this change on 600 surgical procedures performed in an office.
Unidentified Participant:
Fair enough. And then, for Tom, just on the margin profile, I think that's effectively a major change first half versus kind of what we were thinking. Are you managing costs effectively here? Is it mix? Or is this structural improvement towards your previous, like, long-term targets on higher sales?
Thomas Powell:
So, I would say, as we think about the margin improvement in the guidance, I think that's what you're asking, is what's driving that, is that, yes, we obviously are managing expenses and costs. But I would say that really what we saw is very, very nice, I would say, manufacturing efficiency throughout the first half of the year with the expectation that that will continue into the back half of the year. We've also seen a lot of the businesses recover from their COVID kind of depressed levels. And those businesses that recovered well are some of our higher margin brands. So, we saw our surgical, our interventional, interventional urology, all move upwards in terms of their recovery and that helped drive the margin as well. If you think about just kind of the first half, second half, we do expect in the second half of the year that there will be incremental expense associated with running the business as we continue to see our business and really the industry return to more of a normalized state. We expect our people to be out traveling more. We expect to resume hiring, et cetera. And so, we will see some additional operating expenses in the second half of the year relative to the first half. We also have some investment. As we mentioned, we've put some investment into the plan that's incremental to what we previously had, and that's behind the UroLift as well as MANTA. So, I would say that, overall, we're really encouraged by gross margin and where that's going. And then, based on the success in the first half of the year, it affords us the opportunity to put a little more investment in the back half.
Operator:
[Technical Difficulty]
Lawrence Keusch:
Thank you, Dexter. And thank you to everyone that joined us on the call today. We appreciate it. This concludes the Teleflex Incorporated second quarter 2021 earnings conference call. Have a good day.
Operator:
Good day, and thank you for standing by. I would like to welcome you to the Teleflex, Inc., 2021 Conference Call. [Operator Instructions] I would now like to hand the conference over to your speaker today Jake Elguicze, Treasurer and Vice President of Investor Relations. Please go ahead, sir.
Jake Elguicze:
Good morning, everyone, and welcome to the Teleflex, Inc., First Quarter 2021 Earnings Conference Call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website, and a replay will be available by dialing (800) 585-8367 or for international calls, (416) 621-4642, passcode 6194708. Participating on today’s call are Liam Kelly, Chairman, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks, and then we’ll open up the call to Q&A. Before we begin, I’d like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. During this conference call, you will hear management make statements regarding intra-quarter business performance. Management is providing the commentary to provide the investment community with additional insights concerning trends, and these disclosures may not occur in subsequent quarters. With that, I’d like to now turn the call over to Liam.
Liam Kelly:
Thank you, Jake, and good morning, everyone. It’s a pleasure to speak with you today. We are delighted with our first quarter performance, which exceeded the expectations we provided to the investment community on our Q4 call in February and reflected improvements in underlying revenue trends for the product categories most impacted by the postponement of deferrable procedures, most notably, Interventional Urology, Interventional Access and Surgical. Quarter 1 on revenue was $633.9 million, which was down 2.6% as compared to the prior year period on a constant currency basis, driven by continued COVID-19 headwinds. Adjusting for the two less selling days we had during the first quarter of 2021 as compared to the first quarter of 2020, quarter 1 constant currency growth was modestly positive at approximately 0.1%, which marks the third consecutive quarter of improving growth rates and a return to days adjusted constant currency growth for the first time since the beginning of the COVID pandemic in the second quarter of 2020. From an earnings per share perspective, our adjusted earnings per share of $2.87 also significantly exceeded the expectations we provided to The Street. This reflects the recovery we saw in monthly procedures as we moved throughout the quarter, coupled with prudent operating expense management. Lastly, during the first quarter of 2021, we committed to a new restructuring plan designed to streamline various business functions. At Teleflex, we value continuous improvement, and continue to execute on new opportunities to improve the efficiency and cost effectiveness of our business. Turning now to a more detailed review of our first quarter results. As I mentioned, quarter 1 revenue declined 2.6% on a constant currency basis. The decline in revenue was primarily due to lingering COVID-19 headwinds coupled with the impact of two fewer selling days in the quarter compared to the prior year period. When adjusting for selling days, we have experienced positive day sales adjusted contributions from Vascular, Anesthesia, Surgical and Interventional Urology, offset by declines in Interventional OEM and our Other segment. From a margin perspective, we generated adjusted gross and operating margins of 59.4% and 27.5%, respectively. This translated into a year-over-year increase of 210 basis points at the gross margin line and a 190 basis points at the operating margin line. We were encouraged by our growth and operating margin performance, which demonstrated the ability of our business to generate significant leverage despite the impacts of lingering COVID headwinds on our revenue line. In fact, we continue to show significant leverage across the P&L, as we generated the highest adjusted gross and operating margins since becoming a pure-play medical device company. Quarter 1 adjusted earnings per share was $2.87, up 5.5% year-over-year and well ahead of the expectations we provided The Street on our quarter 4 call. Overall, I am very happy with our first quarter financial performance, which demonstrates the resiliency of the diversified global product portfolio that we have built, while also reflecting progress towards our longer-term margin aspirations. Turning now to a deeper look at revenue results. I will begin with a review of our reportable segment revenues and unless otherwise noted, the growth rates I will refer to are on a constant currency basis. The Americas delivered revenues of $375.5 million in the first quarter, which represents growth of 4.7% or 8.3% on a day sales adjusted basis. Growth in the quarter was driven by strength in Vascular, Anesthesia, Surgical and Interventional Urology on a days adjusted basis. EMEA reported revenues of $141.2 million, representing a 16.9% decline or 14.4% on a days adjusted basis. EMEA was impacted by a difficult year-over-year comparable. As the prior year period saw a bolus of ordering ahead of the initial COVID surge as well as a higher level of COVID-related restrictions and elective procedure deferrals that occurred during the first quarter of 2021. Turning to Asia. Revenues totaled $63.7 million, which represents 10.3% growth, with no selling day impact in this region. Importantly, we saw solid double-digit recovery in China, along with double-digit growth in India and Korea. This more than offset declines in Japan and Australia. As we anticipated, the Americas and Asia continue to recover more quickly than Europe. And lastly, our OEM business reported revenues of $53.5 million, which represents a 17.1% decline on a constant currency basis or 16.3% decline adjusted for selling days. As anticipated, our OEM business continues to see a lagged impact related to COVID recovery. Investors familiar with Teleflex will be aware that our OEM business supplies device companies with complex catheters and surgical sutures, and the first quarter impact reflects reduced orders from these customers whose business is tied to nonemergent procedures. As it relates to the acquisition of HPC, we are pleased that the integration has been completed, and we have additional capacity coming online over the next two months, which should help drive growth in the second half of the year. Let’s now move to a discussion of our revenues by global product category. Consistent with my prior comments regarding our reportable segments, commentary on global product category growth will also be on a constant currency basis, with color provided for selling day adjustments as well. Starting with Vascular Access. Quarter 1 revenue increased by 5.8% to $164 million or 9.3% adjusted for selling days, as we had strong contributions from central venous catheters, EZ-IO and PICC product lines. Moving to Interventional Access. First quarter revenue was $96.2 million, which is lower than the prior year by 6.4%. When adjusting for selling days, the year-over-year decline was 3.8%. The decrease was largely due to the delay in the recovery of certain nonemergent procedures due to COVID. The decline was somewhat offset by increases in MANTA large-bore closure revenue, which grew approximately 30% globally adjusted for selling days. Turning to Anesthesia. Quarter 1 revenue was $84.9 million, which represents growth of 7% or 9.9% adjusted for selling days. The revenue growth was due to solid performance of Z-Medica, which performed better-than-anticipated, partly offset by lower sales of laryngeal masks and regional anesthesia products. Shifting to Surgical. Revenue was $80.4 million, representing 2.3% growth or 4.7% adjusted for selling days, driven by sales of our polymer ligation clips and instruments, partly offset by chest drainage and metal ligation decline. Now to Interventional Urology. Quarter 1 revenue was $73.4 million, which was a decline of 1.3%. When adjusting for selling days, the UroLift product grew approximately 1.9%. During the quarter, we continued to see canceled procedures negatively impact growth as COVID case counts surged in January and February. However, as the quarter progressed, we were very encouraged by the strong double-digit growth that occurred in March. The strong growth trends that occurred for UroLift in March continued during April as we continued to see improvements in our average daily sales trends. Importantly, our average daily sales in April were, for the first time, back to pre-COVID daily rates on a consistent basis. We continue to view UroLift as one of the first procedures to be performed as the environment is starting to improve again. We also trained 115 new urologists in quarter 1 and are well on track to achieving our annual target of training between 450 and 500 new urologists during 2021. And finally, our Other category, which consists of our respiratory and urology care products, declined by 15.3% or 12.6% adjusted for selling days, totaling $81.7 million. The decline reflects headwinds to elective procedures as well as difficult comps from the prior year related to COVID ordering in EMEA. That completes my comments on quarter 1 revenue performance. Turning to some clinical and commercial updates. I wanted to provide an update on our direct-to-consumer efforts for UroLift. On the strength of a successful 2020 campaign, where we doubled the awareness for UroLift in the targeted population of men with BPH, and as planned, we have decided to increase our investment in 2021 and run a national campaign for the full year. For this year’s campaign, we are optimizing our network selection, refreshing the ads and working in conjunction with social media campaigns to augment the overall impact. We continue to view DTC as a multiyear catalyst for UroLift in the United States as we are still in the early innings of market adoption and patient awareness. Indeed, UroLift is leading the way in BPH, and this is the first time in recent years that a BPH brand is reaching patients directly in a meaningful way. Turning to UroLift 2. We continue to make progress with our controlled launch, and we remain on track for a more fulsome rollout beginning in the second half of 2021. We remain confident that conversions to the UroLift 2 will continue over time, and we continue to expect to generate significant margin expansion as the revenue base is fully converted. As it relates to the UroLift ATC device, the launch continues to go very well. As we completed multiple case days and urologists find the use of the device to be intuitive and they seem to appreciate that the device makes it easier to perform procedures with obstructive median lobes. Regarding Japan, we remain on track for a reimbursement decision in 2021 and view the approximate $2 billion addressable market as an incremental growth driver that will be a positive catalyst for the foreseeable future. And we continue to work towards commercialization in France. We anticipate performing our first cases during the second quarter. With multiple catalysts in place across key geographies, including the U.S. and Japan, we remain confident that UroLift will become a robust global franchise, addressing a significant multibillion-dollar opportunity. Lastly, before turning the call over to Tom, I would like to provide clinical updates highlighting two recent published studies with our Interventional Access business unit. The MARVEL real-world study was recently published in December of 2020. This study tracked 500 patients across 10 centers globally who underwent transfemoral large bore percutaneous procedures. Primary endpoints of time to hemostasis was a median of 50 seconds. While the primary endpoint of the major vascular complication rate related to the MANTA access site was in line with the safe MANTA IDE pivotal trial. The study concluded that MANTA was a safe and effective device for large bore access closure under real-world conditions. In addition to the registry study I just highlighted, as separate meta-analysis was published in February of 2021. This pooled analysis examines data for nearly 900 patients drawing from the CE mark and SAFE pivotal trial as well as the MARVEL registry study. Key findings included a high technical success rate, rapid hemostasis and low complication rates. In this study, median time to hemostasis was 31 seconds. Overall, we continue to invest in clinical and commercial catalysts that will help to sustain our upper single-digit revenue growth aspirations for this strategic business unit in a normalized environment. That completes my prepared remarks. Now I would like to turn the call over to Tom for a more detailed review of our first quarter financial results. Tom?
Thomas Powell:
Thanks, Liam, and good morning, everyone. Given the previous discussion of the company’s revenue performance, I’ll begin at the gross profit line. For the quarter, adjusted gross margin was the highest since Teleflex became a pure-play metal device company, totaling 59.4% or an increase of 210 basis points versus the prior year period. The increase in gross margin was primarily attributable to product mix, M&A and restructuring benefits, which were partially offset by foreign exchange headwinds. Similarly, first quarter adjusted operating margin of 27.5% was also the highest since Teleflex became a pure-play metal device company and represented an increase of 190 basis points versus the prior year period. The increase was driven largely by the gross margin improvement, partially offset by a normalization of compensation expense accruals. Continuing down to P&L. For the quarter, net interest expense totaled $16.1 million, which is a slight increase from $14.9 million in the prior year period, reflecting higher average debt outstanding. Post quarter close, we issued a notice of redemption to holders of our outstanding $400 million aggregate principal amount of 4 and 7/8% senior notes due in 2026. We plan to fund the redemption using available borrowings under our revolving credit agreement. Moving to taxes. For the first quarter, our adjusted tax rate was 13.9% which is up 140 basis points as compared to the prior year period. The year-over-year increase in our adjusted tax rate is primarily due to less benefit from stock-based compensation as compared to the prior year period. At the bottom line, first quarter adjusted earnings per share increased 5.5% to $2.87. Included in this result is an estimated positive impact from foreign exchange of approximately $0.13. Now I’d like to highlight another restructuring program that we recently announced. During the first quarter of 2021, we committed to a restructuring plan designed to streamline various business functions. We estimate that we will incur aggregate pretax restructuring charges between $7 million and $9 million, consisting primarily of termination benefits and between $3 million and $4 million in restructuring-related charges. We expect to begin realizing plan-related savings in 2021, with total annual pretax savings of between $13 million and $16 million once the plan is fully implemented. To summarize all of our ongoing restructuring and cost saving programs, the total remaining pretax savings across all current active programs are expected to be between $53 million and $67 million. And further details of the programs are available in the appendix to the earnings presentation. Approximately half of the remaining savings are expected to be realized during 2021 and 2022, with the bulk realized by 2024. As such, we have good line of sight to nonrevenue-dependent margin expansion for the foreseeable future. Turning to select balance sheet and cash flow highlights. For the first quarter of 2021, a cash flow from operations totaled $110.8 million as compared to $11.5 million net use of cash in the prior year period or a year-over-year increase of $122.3 million. The year-over-year increase was driven by lower contingent consideration payments, lower payroll and benefit-related payments and higher accounts receivable collections as compared to the prior year. Overall, the balance sheet remains in good shape. At the end of the first quarter, our cash balance was $324.6 million. And during the quarter, we paid down $100 million in debt and our net leverage at quarter end was approximately 2.9 times. Subsequent to quarter end, we repaid an additional $25 million in revolver borrowings. Moving on to guidance. Starting with our revenue expectation for 2021. We now expect constant currency revenue growth between 8.5% and 9.75% as compared to 2020. This compares to our initial guidance, which called for constant currency revenue growth of between 8% and 9.5%. The increase in guidance reflects our confidence in the business, including first quarter results, which were better than we anticipated. We expect our Interventional Urology, Interventional Surgical and Anesthesia product offerings to be key contributors to our constant currency revenue growth during 2021. Additionally, we continue to expect our Interventional Urology business will increase at least 30% over 2020 levels. The midpoint of our constant currency guidance range also assumes approximately 2.5% contribution from the acquisition of Z-Medica. Turning to currency. We continue to expect foreign exchange rates will be a tailwind to revenue growth of approximately 2%. And as a result, we now expect our as-reported revenue to increase between 10.5% and 11.75% over 2020. This would equate to a dollar range of between $2.804 billion and $2.835 billion. Turning next to gross margin. During 2021, we now anticipate adjusted gross margin to increase between 155 and 255 basis points to a range of between 58.25 and 59.25, and this is an increase of 25 basis points versus our prior forecast. We expect gross margin expansion to be driven primarily by a favorable mix of high-margin products, including Interventional Urology, Interventional Access and Surgical. Also contributing our benefits from manufacturing productivity improvement programs, benefits from previously announced footprint restructuring programs and the acquisition of Z-Medica. Year-over-year gross margins expansion is expected to be somewhat offset by inflation. Turning to adjusted operating margin. We continue to expect that adjusted operating margin will increase between 110 basis points and 210 basis points to a range of between 26% and 27%. The increase in adjusted operating margin will largely come from the gross margin line, partially offset by normalization of spending associated with items including management compensation, commissions, targeted headcount additions, and the potential for further strategic investments in support key growth drivers such as UroLift and MANTA. Continuing down the P&L. We now expect interest expense to range between $61 million and $63 million. This compares to our initial guide, which called for interest expense of between $63 million and $65 million. The reduction in interest expense is primarily due to faster-than-originally anticipated debt reductions, coupled with lower-than-expected LIBOR rates. The early retirement of the 2026 notes was always part of our full year interest expense assumptions. Moving to taxes. We now expect our adjusted rate will be in the range of between 13% and 13.5% or a 50 basis point reduction versus our prior guidance. Considering all of these elements, we are pleased to be able to raise our adjusted EPS outlook to between $12.65 and $12.85 for an expected increase of between 18.6% and 20.4%. Lastly, while it is not our normal practice to provide quarterly financial guidance, given the ongoing situation with COVID, I would like to provide some color regarding what we expect to occur in the second quarter of the year. At the midpoint of our new guidance ranges, during the second quarter of 2021, we expect to realize approximately 24.5% of full year reported revenue and approximately 22.5% of our full year adjusted earnings per share. Our outlook is predicated on the assumption that COVID will continue to cause disruption during the first half of the year. And that concludes my prepared remarks. I would like to turn the call back to Liam for closing commentary. Liam?
Liam Kelly:
Thank you, Tom. In closing, I would highlight our key – our three key takeaways from the quarter. First, we delivered a strong first quarter with top and bottom line performance better than our expectations. Second, we announced another restructuring program that reflects our organizational efforts for continuous improvement. This action also contributes to our confidence in long-term margin expansion efforts. And third, we raised our revenue and adjusted earnings per share guidance, reflecting a strong quarter 1 and our outlook for the remainder of the year. I would like to finish by thanking the entire Teleflex team around the world who have worked tirelessly through the pandemic. As we begin to come out the other side of COVID, we will continue to meet our commitments to our patients, clinicians, communities and, of course, our shareholders. That concludes my prepared remarks. Now I would like to turn the call back to the operator for Q&A.
Operator:
[Operator Instructions] And your first question comes from the line of Richard Newitter with SVB Leerink.
Richard Newitter:
Thanks for the color on the trends on UroLift. Maybe just to start off there. So you mentioned that you’ve returned it to pre-COVID UroLift or Interventional Urology growth levels. I’m just curious, is that – you had different growth rates in the first half of 2020 of 40% and then rose to 50% and in the first quarter of 2020, it was about 20%. Which kind of those growth trajectories should we use as a reference point for the early trends that you’re citing here in 2Q?
Liam Kelly:
Yes, Rich, thank you very much for the question. So we are quoting the trends in 2020 pre-COVID. On a days adjusted basis in Q1 2020, even with the impact of COVID in the last few days of – or the last week of March, we grew approximately 26-plus percent in the prior year. So we are very encouraged by the trends that we saw in the month of April. So at different times through the impact of COVID as we got into November last year, Rich, we did see days that we got back to a pre-COVID level on an average daily sales basis. But we have not seen the consistency where it remains for a sequential number of weeks until the month of April and that is very, very encouraging to us. And I will say – and the other data point, I think, is worth looking at is if you compare UroLift growth in this Q1 of 2021 and you compare that back to Q1 of 2019, that is approximately 30%. So we’re very pleased to be able to reiterate our full year expectation for UroLift, a plus 30% growth and the trends that we’ve seen in the last few weeks of March, but more importantly, in the first few weeks of April, have given us the confidence that we will definitely be able to reiterate that long-term – or that full year guidance.
Richard Newitter:
Thanks for that color. Maybe just two follow-ups on UroLift there. One, I know there’s been some management changes in the organization, the Head of – the President of UroLift, as expected and consistent with timing, you’ve said in the past, retired at the end of the year. Can you just talk a little bit about that? I think, ultimately, it would help just to hear if there’s anything potentially changing with the way you’re viewing the market, the direct-to-consumer initiatives, management changes that may be impacting the business? Or if this is just purely COVID that led to the still sluggish trend in the first quarter?
Liam Kelly:
Yes. So I wouldn’t call the trend sluggish in the first quarter. Let’s not forget, in January and February, COVID was much more severe than it was in the fourth quarter. And for us to be able to deliver a growth of approximately 2% in Q1 compared – consistent with Q4, I would see that as an achievement. Another little bit of color I would give you, Rich, is that in the first two months, January and February, we had a decline of approximately minus 8% for UroLift. And in the month of March, it was positive north of 30% in absolute growth year-over-year in the month of March. And we continued, as I said earlier, to see that improving trend as we went into April. So we feel really positive about UroLift. Nothing has changed in the end markets, and we’re still very positive. As anticipated, the President of the business units did leave at the end of the year, but we have an industry veteran coming in to take over that business unit, and the core team is still there. Our turnover in that business unit is significantly less than our turnover in any other part of Teleflex. And Teleflex turnover is well below industry averages. I’ve said it many times, Rich, you just can’t beat culture and our people will stay within Teleflex because of the culture and because of the significant opportunities within there. So no significant changes within the organization below the President level.
Richard Newitter:
Thank you very much, and appreciated.
Operator:
And your next question comes from the line of Cecilia Furlong with Morgan Stanley.
Cecilia Furlong:
Great. Thanks for taking questions. I guess I did want to continue with UroLift. You talked about ex U.S. expansion into France as well as Japan coming online in the back half of this year. I guess just as we’re thinking about guidance and recovery from COVID, can you talk a little bit about just what you’re expecting from the U.S. market recovery from the DTC campaign as that flows in OUS? And then kind of just layering that on it, as you look at gross margin impact from UL2 rolling out, just would love your thoughts on kind of the cadence for the year?
Liam Kelly:
Okay. So again, we’ve again reiterated our plus 30% growth for UroLift in the year. And regarding the growth in France and Japan, we see those as incremental growth to our normalized growth levels for UroLift. We see that the growth and the recovery in our UroLift is going to be really a U.S. phenomenon this year, and we would advise the investment community to focus on the U.S. market. We will generate some revenue in Japan, but we have a mandated registration study to complete and gather some data. So I would really see Japan ramp and France ramp for that matter, as really being a 2022 story, where you see the incremental revenue really start to gain momentum. And as I said earlier, I would see that as an incremental growth driver into the future. With regard to the UL2, we still expect that we will have the key North American market pretty much converted by the end of 2022, and we will have an uptick in our gross margins of 4-fold percentage points, which will account for about 40 basis points for Teleflex in our entirety. Regarding DTC, we are very encouraged by what we saw last year with our DTC campaign. And as I said in my prepared remarks, we are planning to run the DTC campaign for a full year. Because of some of the learnings that we’ve made during that time, we’re doubling the spend, but we’re more than doubling the number of impressions we anticipate making. So we expect to make about 125%-plus additional impressions with the campaign in 2021 as compared to 2020. We are also very encouraged by the number of patients that engage with the urologist and encouraged by what we – the appointment levels that we see being generated out of that. So we are investing more heavily behind DTC by rolling it out for a full year in 2021 compared to 2020. So – and in a recovering COVID environment, there are many patients that we have put under the care of a urologist through the DTC campaign that should turn into procedures now that people feel more confident to go back in and get procedures done in the back half of this year, 2021.
Cecilia Furlong:
Great. And I guess I wanted to just see on Z-Medica, you talked about Q1 performance, slightly ahead of your expectations.Can you just talk a little bit about how that integration effort has gone so far? And really, just how you’re looking at that initial $60 million to $70 million you called out at the time of the acquisition?
Liam Kelly:
Thank you. Yes. So the integration is going exceptionally well. The Z-Medica team are very welcome to the Teleflex family. We are seeing no turnover within our identified retention pool. We have approximately 21 work streams in the integration, and we’re about 35% completed already. Regarding the $60 million to $70 million and the $0.21 to $0.26 in earnings guide that we gave, we feel we’re very comfortably within that $60 million to $70 million, and the product is doing better than we would have anticipated right out of the gate. So we’re really happy with how things are going with Z-Medica.
Operator:
And your next question comes from the line of Matt Taylor with UBS.
Matt Taylor:
So wanted to circle back on UroLift and ask one about new versus existing surgeons. Do you have any insight into the trends that you’re seeing there? Are you seeing the surgeons who have used UroLift in the past are showing same-store growth still? Or how much of new growth is coming from each of those buckets?
Liam Kelly:
So traditionally, about 2/3 of our growth comes from existing and 1/3 comes from new users. We haven’t seen any significant change in that. As we got to the fourth quarter and discontinued within the first, we’re seeing the average number of procedures being done by urologist holding pretty firmly, and that’s quite encouraging. One thing that we did see in the first quarter and during COVID, we saw the percentage shift out of the hospital to the ASC and the office in the midst of COVID, and we saw a few percentage points swing. We’ve actually seen some of that swing back into the hospital as patients now feel more confident going back into the hospital and getting the cases done. So we’re very encouraged by that because our procedure is done in all sites of service. It’s done in the hospital, the ASC and the office. And as we see all of those sites of service begin to come back, as we did in the first few weeks of April, the trends are really encouraging for UroLift, Matt.
Matt Taylor:
Okay. Great. And obviously, the April data point, very positive. But do you – is your hypothesis that you’re going to kind of continue to see those levels through the quarter? Or do you think that you could actually see some momentum acceleration? I mean are your customers or your sales force telling you that there’s a funnel from those canceled procedures in Q2 that are going to start to bounce back as more people get vaccinated?
Liam Kelly:
Well, we know what the canceled procedures were, Matt, in the first quarter, and we know what they were in the second quarter. So we’ve taken the baseline cancellations of 2019, and we have the data on the additional cancellations. So – and cancellations in the first quarter were higher than the fourth quarter as we’d expect because COVID was more aggressive, and we hit record peaks in January and February, in particular. So we had 850 cases, which would equate to around $4 million in the fourth quarter, and we had just shy of 920 in the first quarter. So it’s over $4 million of canceled procedures over the base rates. So those canceled procedures, one would imagine, will come back at some stage as people feel more confident in coming back and having them done. So we’re feeling really good about UroLift as it is right there. And of course, as we said earlier, we got the incremental growth drivers then coming in later into the year and into 2022, such as Japan, France and other geographies.
Operator:
Your next question comes from the line of Larry Keusch with Raymond James.
Larry Keusch:
Liam just hoping to level set a little bit on Japan. Maybe you can – I certainly heard the messaging of – you do have this post-market study that you had to get done, you’re not expecting a lot of revenue this year. But again, just trying to think through sort of what happens with clearance for the UL 2 and then kind of sequentially what happens with reimbursement, maybe just walk us through kind of how you’re thinking about the time lines there?
Liam Kelly:
Yes, Larry. So we are – we’ve all the documentations prepared and submitted to the authorities. And – sorry, we will have them in time for the June meeting, whether they review them in the June meeting, we do not know. But if they don’t review it and give a decision in June, they will give a decision in December or in – pardon me, in September. So that’s the gating point, Larry, as to when we will get a decision on the reimbursement in Japan. As soon as we get that decision, we will begin to do procedures, to comply to the PMDA mandated study that we have to do. We’ve already have the team on the ground. We’ve got the market development specialists on the ground. We’ve already begun to recruit additional sales individuals on the ground in anticipation of getting that reimbursement decision. And Japan has a n advantage over what we had to do in the United States insofar is that it’s a single- payer market. So once we get reimbursement, we have a reimbursement across all sites through the entirety of Japan. And I think then we would see the revenue in Japan ramp as we go through 2020 and beyond. And again, I’ll reiterate what I said, we see this as an addition to the normalized growth levels of UroLift over and above what we’ve seen in predominantly the United States.
Larry Keusch:
Okay. I do have a question for Tom, but I just want to clarify one thing, Liam. So are you saying that you haven’t filed yet for the regulatory clearance? And then you have to get that done before the reimbursement meeting? Or does this happen.
Liam Kelly:
Excuse me. No, we have regulatory clearance already, Larry, pardon me. I was talking about reimbursement submission.
Larry Keusch:
I guess for Tom, look, certainly, on the gross margin side, Tom, you are bumping up against kind of your targets in the pre- COVID LRP. Again, just wanted to think about or have you maybe address a little bit about how you’re thinking about the sustainability of the gross margin after what we saw in the first quarter? And then secondarily to that question, on the restructuring, again, you highlighted the pretax savings that you have in front of you over the next several years. Should we be thinking about that as really all dropping to the bottom line? Or would you consider actually investing some of the restructuring savings to fuel growth?
Thomas Powell:
Well, starting with the sustainability of the gross margin. So as we’ve talked about previously, what’s really driving our gross margin are two things, primarily mix, and I would say that UroLift being the greatest driver, we also have the addition of Z- Medica this year. And so as we continue to see UroLift and other high-margin product offerings continue to outpace the rest of the business, we’re going to continue to see margin expansion for this year and into the future. Now with regard to the other piece of restructuring programs, as mentioned, we do have a couple of years outlined already of programs that are out there, and we expect to realize some significant savings. And if you do the math on that that’s close to one basis points of margin expansion right there. As we think about, do we drop this through? I think from our perspective, we’re going to continue to evaluate what are the options to kind of look at opportunities to enhance growth with further investment behind our high-margin brands such as UroLift, Z-Medica, MANTA as well as considering what level of profitability increase we’ve got. So we’ve got the opportunity to continue to drive meaningful top line growth, meaningful margin expansion, and that’s going to translate to meaningful earnings per share growth. And we’ll continue to evaluate what are the opportunities to invest further to accelerate that top line even more.
Operator:
Your next question comes from the line of Matthew Mishan with KeyBanc.
Matthew Mishan:
Tom, just back to the gross margin. I mean if you – if mix is really what’s driving a lot of the improvement, but just sequentially, Z-Medica, UroLift are all moving higher, sales are moving higher, probably the mix of COVID-related products move a little bit lower. Why would the gross margins decline from here in 2Q, 3Q and 4Q with increasing sales? And what’s offsetting that?
Liam Kelly:
Well, I would first say that in the first quarter, we had an incredibly clean quarter from a corona standpoint in manufacturing. And then also to the point you’ve raised, as we look at the recovery in the back half of the year, we – I should say, in the first quarter, both EMEA and OEM had about 70% constant currency declines in revenue. As we look to the back half of the year, we expect both of those businesses to move into positive territory, and that’s going to have an adverse impact on our mix. And that will partially offset some of the higher growth from UroLift and other high- margin brands. Now obviously, we’re waiting to see how the recovery plays out over the next couple of weeks and months. And hopefully, as we continue through the year, we continue to see favorability in the gross margin line.
Matthew Mishan:
Okay. Excellent. And on the OEM side, when does that inventory normalize versus where production – versus where customer activity is?
Liam Kelly:
So Matt, it should lag about a quarter. So you should expect to see a beginning in quarter two a recovery. And then in the back half of the year, you should definitely see it start to pick up. So it will lag by about a quarter. So my expectation would be that OEM results in Q2 would be better than they were clearly in this quarter, and then you’ll get into positive countries get into the back half of the year. An OEM for the full year should grow in that mid single-digit growth rate over all.
Matthew Mishan:
Okay. Excellent. And just back to Tom. So free cash flow was excellent in the first quarter. How should we be thinking about free cash flow in 2021? And have we reached the point now that we’re going to see that inflection in free cash flow that you were talking about back in next 2020, 2022?
Thomas Powell:
Yes. So the way I’d look at free cash flow is that we’d expect it to be growing kind of in line with earnings growth in the 20% range. A couple of things going on in 2021. First of all, we’re going to see an increase from net income. We’ll also see an increase as a result of less contingent consideration payments. We spent about a little under $18 million last year, and we expect that to be significantly less this year. However, last year, we also closed out the year with a very, very strong collection cycle where our DSOs were down considerably from our historical average. And this year, we’ve planned it to be closer to our historical average to the extent we continue to see favorable trends in collections, we could see more than that 20% growth in free cash flow that I cited.
Operator:
And your next question comes from the line of Matt O’Brien with Piper Sandler.
Andrew William:
This is Drew on for Matt. I think maybe I know the answer to this question, but I just want to ask about the competitive landscape for UroLift. You have Boston talking about good progress with it’s Rezum product yesterday. I believe you have Olympus also rolling out a new product in the space. Anything new with those technologies? And are you seeing any shifts though to utilization within the market?
Liam Kelly:
So we’re seeing no changes in the marketplace. I think that year-over-year growth in this environment is a tough one to call because you don’t know what happened in the prior year with some of these companies. So I can tell you, last quarter, when Teleflex in our entirety, we grew 5.5% on a days adjusted basis. So – and if you look at our growth in Teleflex and our entirety in 2019, constant currency days adjusted, we grew 5.8% over 2019. So we feel that the momentum swing is really moving favorably for us. And we also see no changes in the end markets. At the end of the day, it all comes down to patient outcomes that no sexual dysfunction, will the man have to wear a catheter and revision rates for UroLift that are comparable to the gold standards tough. And of course, don’t forget that the man has a choice with UroLift were to get procedure done. Do they want to go to a hospital, an ASC or an office. With some of these other technologies, they are restricted as to where they can have the procedure done. So no change in the end market, and I can categorically tell you, we have lost no customer to any competitor.
Andrew William:
Okay. That’s obviously great to hear. And congrats on the strong performance with MANTA. I believe you mentioned 30%- plus growth. Maybe you could just kind of help us by framing where that number was relative to the estimates and then relative to the penetration targets you laid out a couple of quarters ago?
Liam Kelly:
So we’re very pleased with the growth. You’re correct, it was 30% growth within the quarter, which is very encouraging. It is in line with our trajectory, even given the worsening situation with COVID in January and February. And we expect to continue to see that momentum build as we go through the remainder of the year, and we do believe we will get to our 8%- plus penetration by the end of the year. So MANTA is performing very much in line with our expectations, and we’re very encouraged by it.
Andrew William:
Thank you.
Operator:
Your next question comes from the line Anthony Petrone with Jefferies.
Anthony Petrone:
Maybe one on UroLift and a couple of regional questions. One UroLift is just maybe the competitive dynamic, I guess, both versus existing alternative devices, Boston Scientific spoke a bit about Rezum on their call they also saw increasing volumes in March. So just an update on competitive dynamics and getting into new sites, would be the first question. And maybe a second quick one on EMEA. Or maybe, Liam, just touched more broadly on EMEA, obviously, lagged in the quarter. COVID is still somewhat heightened. They’re opening up. So maybe just thoughts on when we’ll see a reversal in EMEA broadly? And then I’ll have one quick follow-up.
Liam Kelly:
Yes, Anthony, thank you. So yes, the growth that we saw in March for UroLift was north of 30% so – over the prior year. So we’re really encouraged by that. And we’re also, as I said earlier, encouraged by the momentum that we saw going into April, where we saw continued sequential improvement in our average daily sales going into April, getting back above our pre-COVID levels for the first time. I mean that’s a big water shed moment for us, Anthony, as you can appreciate. We haven’t been consistently being back above pre-COVID levels for the first time. I mean that’s a big water shed moment for us, Anthony, as you can appreciate. We haven’t been consistently being back above pre-COVID levels for an entire year now. And so the team is absolutely fired up out there in driving that. Regarding your question on EMEA, EMEA was as expected. There’s a few dynamics going on there. Last year, EMEA received a positive $8 million COVID order in the prior year quarter. So they had that tough comp. And as we all know, the rollout of the vaccine in Europe is not going as well as it is in the United States. And I think that the increase in cases in COVID in January and February and well into March within Europe was pretty strong, lots of lockdown still going on. Now having said that, the month of April in EMEA has also been somewhat encouraging. So I would expect EMEA to have a much better second quarter than it did the first quarter. And it would be remiss of me not to mention APAC. APAC, Anthony, grew over 10% on a days adjusted basis in the quarter from a minus 7% in quarter 4. So that was a tremendous swing for us and China had a really, really strong first quarter as we see procedures begin to come back in that key geography for us. So that’s some of the regional color, Anthony, for EMEA, but also APAC.
Anthony Petrone:
Very helpful. Wonder if I could just sneak in, would be on EZPlaz, and maybe just a quick update there and a recap of the opportunity, maybe starting with military? And then broadly, as you roll that out, should we still be thinking about that as addressing $100 million TAM again.
Liam Kelly:
Yes, you’re absolutely correct. That EZPlaz addresses $100 million TAM, $25 million in the military, $75 million in the civilian. As we all know, we’re going to begin in the military market to help develop this product. Very encouraging signs from the FDA. We got a letter from the FDA following our BLA submission stating that the application was sufficiently complete to begin substantive review, and the BLA was assigned priority review classification, which indicates that they’re going to – it is on a fast track BLA. Very collaborative. We’re getting questions back, which is what we would expect. The team is answering them. So very collaborative over and back, and we would anticipate normal approval is put it point to the fourth quarter. So as they move through this, we’ll keep the investment community updated.
Operator:
And your next question comes from the line of Mike Matson with Needham & Company.
Mike Matson:
So there’s so much focus here from investors on acquired products like UroLift and MANTA. I almost feel a little sorry for your R&D team there. But I was wondering if there was any internally developed new products that you’re excited about that we should be aware of?
Liam Kelly:
So for our R&D team. They’re doing a tremendous job internally for us. So we have a number of new products that we are excited about being developed internally within the anesthesia group, we have the Polaris, which is a laryngoscope, a handle and b lade system that we’re getting really good traction on. Within the Vascular business. We have Project Phoenix , which is a new ergo pack that is gaining tremendous traction right now for us within the group. Within the Interventional group, we have the Wattson Guidewire, which is a 2-in-2 combination product that will be launched later in the week that we’re very encouraged by. And of course, the AC3 continues to gain tremendous traction, and we had a really strong quarter with that product, in particular, in China, as we start to roll that out in that geography, having gained approval for it. So across the board, we’ve got a lot of products coming through the R&D group. And we’ve been quite successful in augmenting our revenue growth from new products to the positive over the last number of years. A few years ago, we used to generate 1% in new revenue growth from new products to the positive over the last number of years. A few years ago, we used to generate 2% in new revenue growth from new products, and we’ve moved that up to 1.5% to 2% over the past number of years. And the other thing I’d point out, and it’s not related to your question on new products. But we have also had positive pricing within the quarter. So I think that we’re very encouraged by our ability to increase our prices even in this tough environment, and that’s a positive sign for us also.
Mike Matson:
Okay. Didn’t mean to apply that they weren’t doing their job. Just investors are focusing on some of the external stuff. So – and I wanted to give a – I was going to let you free to talk a little bit about some of the internal stuff. But and then, I guess, just on MANTA. So MANTA, I mean – look, 30% growth. I don’t want to take anything away from that, that’s obviously really good. But at the same time, I mean, the clinical data on this thing is pretty outstanding. So what is the pushback that you get? I mean is it just price? It just seems like a no-brainer to use this thing to me. And if it’s price, I mean, do any of the trials have any kind of economic data in them? Or do you have any trials planned to collect any kind of economic data to kind of help with the VAC committees and things like that?
Liam Kelly:
So getting through the VAC getting through the VAC committees has not been an issue for us, Mike, with the MANTA product. In the first quarter, we’re really happy with the 30%. The issue we have is COVID in the first quarter, quite frankly, in gaining access because it’s difficult to gain access to the hospitals, especially in January and February. Now I know we’re sitting here in April, and we’re – January and February seemed like a long time ago. But don’t forget we were getting 250,000 cases a day in January and February, they were much worse than November and December. So it was very difficult for us to get sales representatives, clinical experts out there into the market that’s showing the product. And I would anticipate that we’ll continue to see that ramp now as people – more people are getting vaccinated and our access to the hospital will be much better.
Operator:
And you do have a follow-up question from the line of Richard Newitter with SVB Leerink.
Richard Newitter:
Just wanted to follow-up. There may be some confusion just around the commentary with respect to pre- COVID UroLift growth rates. Liam, can you just clarify, you’ve grown around, I think, greater than 30% in April. What’s that relative to? Is that relative to April 2020 or is that relative to April 2019?
Liam Kelly:
That was relative to – so the 30% was in March, and it was relative to the March of 2020, Rich. The 30% that I quoted was for the quarter and that was compared to 2019. So we grew 30% in March compared to March of 2020. And in the whole quarter one of 2021, we grew 30% over 2019. As we went into April, our average daily sales got back to average daily sales levels, we have not seen consistently since January and February of 2020 before we headed into COVID.
Richard Newitter:
Okay. And my understanding was that January and February of 2020 were exceptionally strong, I mean, well north of 30%?
Liam Kelly:
Yes. Our growth in January and February, from my memory, we were about 30-ish percent or something like that, Rich.
Operator:
And your next question comes from the line Shagun Singh with Wells Fargo.
Shagun Singh:
Sorry, can you hear me?
Liam Kelly:
Yes.
Shagun Singh:
So just in looking at pre COVID years, Q2 sales is typically 6% over Q1, EPS is about 60% higher. And I think your Q2 guidance contemplate sequential growth of 5% and EPS flat at the midpoint. So I was just wondering if you could talk to that for Q2 versus in Q1? And then just looking at growth on a stack 3-year basis, it appears a pretty similar for Q2 versus what you’re contemplating for the second half. So should we view it as conservative? And then that brings me to my final question, which is with respect backlog. How are you thinking about it? I think we’re increasingly hearing that we should expect more of a steady flow at elevated levels versus a catch-up, if you will, over a one or two quarter period. So any commentary on that would be helpful.
Liam Kelly:
Yes. I’ll start with the backlog and the – I’ll address the conservatism, and I’ll let Tom get into the specifics of the guide in the quarter as to where it would be. But I would say that you will see acceleration in revenue dollars, and you’ll see acceleration in adjusted earnings per share as you get through the quarter, I think we should start there as we continue to expect the recovery to continue. It’s really difficult for us to forecast or identify the backlog, and it is difficult for us to build that into any forecast because we don’t know what type of capacity that’s going to be there within the hospital system are outside of the hospital system for us to get there. We do expect though that backlog should get burned through as you get later into the year and that would be our expectation. With regard to whether the guide – so the guide would be roughly – and I’m talking – trying to pitch it towards the middle here, Shagun, so it should be about $690 million and about $0.02 in earnings per share at the midpoint in both of the guidance that we gave in relation to that. Now regarding conservatism or not, I think we continue to see some increases in COVID cases in places like India and Japan. We see Americas recovering. We think we’ll see OEM continue to get better in the second quarter as we will with EMEA. And we do believe that there could be opportunities for us there in the second quarter, but we would prefer to lean more to the conservative than be aggressive at this stage, just given there’s a few variants around there, so we would prefer to lean in that direction. And if recovery continues within the Q2, we think that we should be in a good position to take advantage of that would be our thinking. And just to be absolutely clear, that $690 million would be up from what we did this quarter, which was around $634 million. So it would see significant sequential improvement on an absolute dollar basis on revenue, Shagun.
Thomas Powell:
And then as it relates to earnings, I think Liam pointed out that we expect to see sequential acceleration in earnings per share. Also, we expect to see sequential improvement in adjusted earnings per share versus prior year. When we take a look at – if you go back two years, I think we had a really strong Q1, the growth rate isn’t as strong in the back half of the year. A couple of things to understand, as we look at the first quarter of 2021, I had pointed out earlier that we had a really clean first quarter from a manufacturing performance standpoint. And while we’re very encouraged by that performance, we’re not quite ready to extrapolate that to a full year upside to that level. Additionally, I mentioned that EMEA and OEM were down in the first quarter in terms of revenue growth, and we expect them to recover and turn into positive territory for the back half of the year. And both of those business segments carry a lower gross margin than average. And I’d also say that in the first quarter, we had a really, really significant beat in operating expenses and part of that was due to savings from travel and perhaps slower hiring than expected. But the vast majority of it was due to deferred projects. So projects that we had expected to get going in the first quarter that we eventually delayed just given COVID and other reasons. Now we do expect to make those up in the back half of the year. So some of that OpEx saving and upside from the first quarter, we expect to be included in the rest of the year spend. So hopefully, that helps give you some color as to what’s going on from an earnings standpoint and why the first quarter just looks so fantastic, evenly benchmarked against two years ago.
Operator:
And your next question comes from the line of David Turkaly with JMP.
David Turkaly:
I have been bouncing around a little this morning, but I just wanted to ask one quick one for Tom. I think you mentioned with sort of a hot topic as late, in general, but inflation. And I was just curious as to what specifically you’re referring to? And if there’s any input that we should be aware of that may be undergoing some sort of a pricing increase as we think about the rest of this year?
Thomas Powell:
Sure. Well, I would say that we are seeing inflation that’s a little bit higher in 2021 than what we’ve seen historically. A lot of it was anticipated and included in our original plan. Our current projections reflect what we see as the current environment. I’d say the areas where we’re seeing inflation is in some material, in particular, resin, polyethylene, polypropylene, polystyrene are all well above 10% inflation rates. But overall, materials, we’re seeing at a sub-2% inflation growth rate. I would say that select labor markets, we’ve got some inflation going on in Malaysia, that would be pushing up around 5%. But overall, I would say that total direct-indirect labor is sub-5% in terms of inflation. The other area that we are seeing heightened inflation rates is in our freight. In particular, our sea freight is up significantly, where it’s up 20% this year. And I think if you follow what’s going on, there just isn’t capacity. So collectively, as we look at all of the different inflation components in manufacturing, we’re up around 3% for the year, is our current expectation. That’s up about a full point versus what we’ve seen historically. And again, that’s fully reflected in our current projections.
Liam Kelly:
I would just add to that, and I mentioned it a little earlier, we anticipated seeing some of this inflation. So we took some actions over. About a year ago, we started taking some actions on some of our pricing initiatives. And that started to come through in this first quarter. And pure pricing in the first quarter we were positive about 20 basis points. So we’re quite encouraged by that. We anticipated this, and we immediately began to plan to have an offset. So modest price increases in some of our more selective areas of business.
Operator:
I would now like to turn the conference back over to Jake Elguicze for closing remarks.
Jake Elguicze:
Thank you, operator, and thank you to everyone that joined us on the call today. This concludes the Teleflex Inc. First Quarter 2021 Earnings Conference Call Have a nice day.
Operator:
Ladies and gentlemen, thank you for participating. You may now disconnect your lines.
Executives:
Jake Elguicze - Treasurer, VP of IR Liam Kelly - Chairman, President, CEO Thomas Powell - EVP, CFO
Analysts:
David Lewis - Morgan Stanley Larry Keusch - Raymond James Shagun Singh - Wells Fargo Matt Taylor - UBS Richard Newitter - SVB Leerink Anthony Petrone - Jefferies Matthew O'Brien - Piper Sandler Matthew Mishan - KeyBanc Mike Matson - Needham & Company
Operator:
Ladies and gentlemen, thank you for standing by and welcome to the Q4 2020 Teleflex Incorporated Earnings Conference Call. [Operator Instructions]. I would now like to hand the conference over to your speaker today, Mr. Jake Elguicze, Treasurer and Vice President of Investor Relations. Thank you. Please go ahead, sir.
Jake Elguicze:
Thank you. Good morning, everyone, and welcome to the Teleflex Incorporated Fourth Quarter 2020 Earnings Conference Call. The press release and slides who accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing 855-859-2056 or for international calls 404-537-3406 passcode 8789956. Participating on today's call are Liam Kelly, Chairman, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks and then we'll open up the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are in fact forward looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today, as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. Additionally, during this conference call, you will hear management make references to the estimated positive or negative impact that COVID-19 had on our operations during the fourth quarter and full-year of 2020. You'll also hear management make statements regarding intra-quarter business performance during the first quarter of 2021. Management is providing this commentary to provide the investment community with additional insights concerning trends and these disclosures may not occur in subsequent quarters. With that said, I'd like to now turn the call over to Liam.
Liam Kelly:
Thank you, Jake, and good morning, everyone. It's a pleasure to speak with you today. Before I get into the details of our quarterly performance, I'd like to once again offer my sympathies to anyone who has been impacted by COVID-19 as well as my sincere thanks to all the healthcare workers who continue to put themselves at risk to battle this each day. I'd also like to take a moment to again recognize the Teleflex employees around the world. This past year has been challenging, but our team has done a tremendous job serving our customers and patients globally, overcoming obstacles to manufacture and distribute our products to the people that need them most. Thank you. Now turning to our results. Considering the volatile environment we operate in, we are pleased with our Fourth quarter performance as our business did better than we expected and trends continued to improve across many of our product categories and geographies. We saw better-than-expected sequential improvement from quarter to 2 quarters and from quarter 3 to quarter 4. Despite a rising number of COVID-19 infections that occurred throughout the fourth quarter, the recovery in our business was led by product lines that were initially most negatively impacted by COVID-19, those being our Interventional Urology, Interventional Access and Surgical businesses as well as continued strength within our Vascular Access and other product categories. While from a regional perspective, we saw strength within the Americas as well as positive growth within EMEA and improving trends in Asia. Quarter four revenues totaled $711.2 million, which represents an increase of 2.3% as compared to the prior year period on a constant currency basis. Growth in the quarter was aided by 2 additional selling days, which we estimate contributed approximately 3% points. Excluding the impact of the additional selling days, we estimate that our constant currency revenues declined approximately 1%. The day's adjusted declines reflect continued recovery progression relative to the 4% decline we experienced during the third quarter of the year and the 12% decline we experienced during the second quarter of the year and it was ahead of the expectations we had at the time of the third quarter earnings call. During the fourth quarter, we estimate that headwinds associated with COVID-19 caused a net negative impact of approximately $61 million or approximately 9%. If we were to normalize for the negative impact, we estimate that our underlying business grew by approximately 11% on a constant currency basis, or 8% when normalizing for the selling day impact. In addition to seeing continued sequential improvements in our constant currency revenue performance during Q4, we also saw a significant sequential improvement within our adjusted gross and operating margins as compared to the second and third quarters of the year. This improvement drove adjusted earnings per share, which exceeded our internal expectations. Lastly, I am happy to announce that on December 28th, we closed the acquisition of Z-Medica a market leader in hemostatic products. We are pleased to be able to deploy capital for a differentiated product portfolio that leverages the existing Teleflex call points and is immediately accretive to our revenue growth rates, adjusted gross and operating margin profile and our adjusted earnings per share. Turning to a more detailed review of our fourth quarter results. As I just mentioned. Quarter four revenue grew 2.3% on a constant currency basis and 4.4% on an as reported basis. The increase in revenue was driven by our Vascular Access Portfolio, which saw some tailwinds in terms of COVID- related purchasing and solid mid-single-digit growth of Interventional Urology and our other segment. From a margin perspective, we had generated adjusted gross and operating margins of 58% and 26.6% respectively. This translated into a year-over-year declines of 120 basis points at the gross margin line and 50 basis points at the operating margin line. However, from a sequential standpoint, this represented an improvement of AZ and 150 basis points respectively compared to quarter three levels. On the bottom line, adjusted earnings per share was $3.25. Overall, our financial performance in the quarter demonstrates the sustained resilience of our diversified global product portfolio and it gives us confidence in our ability to achieve our long-term financial objectives once we get past COVID-19. Let's now turn to a discussion of our quarterly revenue trends, which will be on a constant currency basis. The Americas delivered revenues up $419.5 million in the fourth quarter, which represents an increase of 5% over the prior year period. Growth within the Americas was driven by Vascular Access and respiratory products which both saw elevated demand driven by COVID. In addition, Interventional Urology was a strong contributor as UroLift continues to be our fastest recovering procedure. However, there were offsets with declines in other product categories. We estimate that the Americas would have grown approximately 12% excluding the impacts that COVID-19 had on the region. EMEA reported revenues of $161.4 million in the fourth quarter, representing growth of 4.1%. During the quarter, EMEA benefited from a one-time order of tracheostomy products and from the extra selling days, the combination of which more than offset our estimated 1% COVID headwinds. Turning to Asia. Revenues totaled $78.6 million in the fourth quarter, which represents a decline of 7.2%; however, we estimate that we would have had positive constant currency revenue growth in the mid-single digits, if not for the impact of COVID-19. Additionally during the fourth quarter, we finished transitioning a distributor in Japan. When normalizing for both COVID and the distributor change, growth in the region would have been in the mid to high single-digit range. And lastly, our OEM business reported revenues up $57.7 million in the fourth quarter, which was down 6.9% on a constant currency basis. As we anticipated during the fourth quarter, our OEM business saw aligned impact related to COVID relative to our other businesses. Investors familiar with Teleflex will be aware that our OEM business supplies device companies with complex catheters and surgical sutures and the quarter four impact reflects reduced orders from these customers whose business is tied to non-emergent procedures. Excluding the impact COVID-19 had, the business grew roughly 31%, which includes a benefit of approximately 13% from the acquisition of HPC. As it relates to HPC, I am pleased to report that we remain on track with our integration efforts. Let's now move to a discussion of our revenues by global product category. Starting with Vascular Access, fourth quarter revenue increased 16% to $182.5 million. We estimate that COVID-19 positively impacted the growth rates of our vascular products during the fourth quarter by approximately 5%. Key drivers of revenue growth included PICC, which increased approximately 20%, CVCs which increased approximately 16% and EZ-IO which grew approximately 14%. Moving to Interventional Access, fourth quarter revenue was $106.7 million or down 6.9% as compared to the prior year period. The decrease was largely due to the delay in the recovery of certain non-emergent procedures because of COVID 19 along with the negative impacts stemming from a catheter recall and distributor conversion in Japan, both of which began last quarter. We estimate that the recall and distributor issue impacted our business negatively by approximately $3 million. We expect the impact on the recall to continue to linger for the next few quarters as we do not expect to be back on the market with this product until September of this year while the distributor inventory headwind should reverse and be a modest tailwind for us in 2021. When normalizing for the impact that COVID had along with the aforementioned headwinds, we estimate that underlying growth was in the high single digits consistent with our long-term growth outlook for the segment. In addition, we are pleased that Manta grew 33% globally in quarter four. Now turning to Anesthesia, revenue was $86.1 million, which is lower than the prior-year period by 2.1%. The revenue decline was the result of lower sales of laryngeal masks and endotracheal tube products. We estimate that COVID had an approximate 1% negative impact in the quarter, implying flattish performance on an underlying basis. Since we closed the Z-Medica acquisition just days before year-end, its impact was immaterial on quarter four results. Shifting to Surgical. Revenues declined by 5.7% to $92.3 million driven by lower sales of our ligation portfolio. We estimate a 9% headwind from COVID during quarter 4 indicating recovery as compared to the estimated 13% COVID headwind in quarter three. Moving to Interventional Urology. Quarter four revenue increased by 5.3% to $93.9 million, which represents a new high watermark in terms of revenue dollars in any given quarter. On a year-over-year basis, the business faced a difficult growth comparison but sequentially, it grew by 15% versus quarter three. We estimate an approximate 28% COVID-19 related headwind during quarter four. Notwithstanding the significant headwind on our growth in quarter four, we are pleased with the path to recovery for this business unit and are also happy with the impact of the national DTC campaign, which is exceeding our expectations. Additionally, we are encouraged that we trained approximately 130 new urologists in quarter four moving to a cadence that is consistent with our expectations prior to COVID and a positive leading indicator for future growth. And finally, our other category, which consists of our respiratory and urology care products grew 6.1% totaling $98.1 million. We estimate the growth during the quarter was partly due to increased demand for certain humidification and breathing products resulting from COVID-19 mainly in the Americas. That completes my comments on quarter four revenue performance. Turning to some recent clinical and commercial updates. Starting with UroLift, the response to our national DTC campaign is exceeding our expectations. The strategic role of DTC is important as about half of the 12 million men being treated for BPH believe prescription medications are their only solution. Overall, we view the pilot national DTC as a successful campaign. Key statistics include a doubling of brand awareness among men age 45 are higher post campaign versus pre-campaign levels. Approximately 150% increase in visits to UroLift.com during the campaign and direct response numbers that exceeded our internal projections by a wide margin. Lastly, we know that Google search trends demonstrate a significant and sustained increase in response to the campaign. As such, we expect to continue the national DTC effort in 2021 and beyond. Turning to UroLift too. We have completed the market acceptance test and received positive feedback across more than 100 procedures completed by 20 urologists. We have begun a full controlled launch. The launch is controlled due to restrictive access caused by COVID-19. This will ensure we don't disrupt growth recovery with a more fulsome rollout beginning in the second half of 2021. We remain confident that conversion to the UL2 will occur over time and we continue to expect to generate significant margin expansion as the revenue base is fully converted. Regarding Japan, we remain on track for reimbursement decision in 2021 and view the approximate $2 billion addressable market as an incremental growth driver that will be a positive catalyst for seeable future. Overall between nationwide DTC, Japan rollout, and the launch of UL2, we have multiple drivers to build momentum as we seek to further expand our leadership position in BPH. Turning to the next slide on key clinical updates. Recently a comparative analysis of sexual function outcomes from UroLift studies and the Medical Therapy of prosthetic symptoms trial was published in the peer-reviewed journal European Urology Focus. The comparison reveals that UroLift is superior to BPH medical therapy in preserving erectile and ejaculatory function and sexual satisfaction. Importantly, this study challenges the idea that medical therapy is the most conservative treatment option for BPH. Over time, we believe that more clinical research like this publication consider UroLift as a first-line therapy for treating BPH. Turning to an update on Interventional Access. Regarding the CTO-PCI study that we mentioned on our Q2 earnings call, I am pleased to announce that we have completed enrollment for this study. This is a prospective, single-arm IDE study of 150 patients across 13 sites to evaluate the performance of the entire range of Teleflex coronary guidewires and specialty catheters in chronic total occlusion percutaneous coronary intervention procedures, which is the most demanding PCI environment. Once the study results are finalized, we anticipate updated labeling for our Guidewire and Specialty Catheter products which can address an estimated 100,000 CTO-PCI procedures. Overall, we continue to invest in clinical and commercial catalysts that will help to sustain our upper single-digit revenue growth aspirations in a normalized environment. Lastly, turning to EZPlas. I am happy to update the investment community that we successfully submitted our BLA to the FDA in late January. We recently performed a market assessment update and still see a $100 million initial market opportunity for EZPlas. We are increasingly confident in our ability to address this commercial opportunity with revenue likely ramping in early 2022. In addition, we believe there are potential revenue synergy opportunities with Z-Medica to leverage their sales reps as well as our channel strength across the healthcare and government call points which could add to our baseline expectations, which brings me to an update on our latest acquisition. On December 28th, we completed the acquisition of Z-Medica, an industry leading manufacturer of hemostatic products that is a classic Teleflex deal and a great strategic fit. Investors familiar with Teleflex will be aware that we aim to invest in innovative products and technologies that can meaningfully enhance clinical efficacy, patient safety and comfort, reduce complications, and lower the overall cost of care. Given their differentiated products and attractive end markets, we view the Z-Medica acquisition like that of Vidacare from a few years ago. Since we acquired Vidacare in 2013, we have more than double the sales which are still growing in the healthy double-digit range. One difference is that Z-Medica is growing into a $600 million addressable market while Vidacare is addressable market was closer to $250 million. Regarding our long-range financial targets. Z-Medica only reinforces our ability to get to those goals, and we remain committed to delivering constant currency revenue growth of at least 6% to 7% on an annual basis and reaching 60% to 61% and 30% to 31% adjusted gross and operating margins once we return to a more normalized environment. We plan to hold an Analyst Day event in the fall of this year, at which time we intend to provide updated long-term financial goals and timetables. This completes my prepared remarks. Now I would like to turn the call over to Tom for a more detailed review of our fourth quarter financial results. Tom?
Thomas Powell:
Thanks, Liam and good morning, everyone. Given the previous discussion of the company's revenue performance, I'll begin with the gross profit line. For the quarter, adjusted gross margin was 58%, a decrease of 120 basis points versus the prior year period. The decrease in gross margin was primarily due to COVID-related impacts, including unfavorable product mix and higher manufacturing costs along with a modest foreign exchange headwind. In total, we estimate that COVID negatively impacted our adjusted gross profit by approximately $44 million in the quarter. We continue to tightly manage discretionary spending, partially offset the reduced revenue and gross profit resulting from COVID. As a result of the efforts, we estimate that operating expenses were reduced in the fourth quarter by approximately $13 million. For full-year 2020, we managed OpEx lower by an estimated $78 million. Fourth quarter operating margin was 26.6%, were down 50 basis points year-over-year. Continuing down the income statement. Net interest expense totaled $18.5 million, which is an increase of 10% year-over-year and reflects higher average debt balances versus the prior year period due to the acquisitions of HPC and Z-Medica. Moving to taxes, for the fourth quarter of 2020, our adjusted tax rate was 10.1% as compared to 7.7% in the prior year period. At the bottom line. Fourth quarter adjusted earnings per share declined modestly to $3.25 from $3.28 a year ago. Included in this result is an estimated adverse impact from COVID of approximately $0.55 and a foreign exchange tailwind of approximately $0.05. Turning to select balance sheet and cash flow highlights. In 2020, cash flow from operations was flat as compared to 2019 totaling $437.1 million. We are pleased with this outcome given COVID headwinds and increased contingent consideration payments that flowed through cash flow from operations in 2020 as compared to 2019. Overall as we exited 2020, the balance sheet remains in good shape. At year-end, our cash balance was $375.9 million as compared to $301.1 million as of December 2019. Over the course of the year, we deployed more than $750 million for external business development opportunities. We'll continue to balance our investments across both organic, inorganic initiatives to fuel our growth and drive margin expansion with M&A as our primary focus for capital deployment. Inclusive of Z-Medica financing, we net leverage ended 2020 at 2.98 times, which remains well below our 4.5 times covenant. Lastly, we have no near-term debt maturities of material size. In summary, despite facing the challenging operating environment during 2020, the organization adapted quickly and executed well. We remain optimistic toward the future and expect to recovery beginning in the second half of 2021. As such, we are reinstating financial guidance for 2021. To begin, I'll provide a framework of key assumptions underlying our financial guidance. Our outlook contemplates COVID disruption continuing through much of the first half of the year, with the second half of the year much closer to a normal operating environment. Our baseline assumption assumes that healthcare systems can manage through incremental COVID surges while applying past learnings to avoid widespread procedure shutdowns. It also excludes any material regulatory, healthcare or tax reforms, as well as any future M&A. Lastly from a selling day perspective, we will have 2 fewer selling days in the first quarter as compared to the year-ago period, we will have one additional day in the 4th quarter as compared to the year-ago period, and there will be no differences in the number of days during the second and third quarters. In 2021, we project constant currency revenue growth between 8% and 9.5% as compared to 2020. We expect our Interventional Access, Surgical and Vascular Access product offerings to be key contributors to our constant currency revenue growth during 2021. We also expect our Interventional Urology business to increase at least 30% over 2020 levels. Additionally, Z-Medica is expected to contribute $60 to $70 million of revenue or approximately 2.5 points of growth. Turning to currency. We expect foreign currency exchange rates will be a tailwind to revenue growth of approximately 2%. As a result, we expect our as-reported revenue to increase between 10% in 11.5% over 2020 and this would equate to $1 range of between $2.791 million and $2.829 million. Turning next to gross margin. During 2021, we anticipate that adjusted gross margin will increase between 130 and 230 basis points to a range of between 8% and 59%. We expect gross margin expansion will be driven primarily by a favorable mix of high margin products primarily, Interventional Urology as well as the acquisition of Z-Medica which will add approximately 50 basis points to gross margin. Moving to adjusted operating margin. During 2021, we anticipate that adjusted operating margin will increase between 110 and 210 basis points to a range of between 26% and 27%. The increase in adjusted operating margin will be sourced from the gross margin expansion, partially offset by normalization of certain 2020 COVID-related spending reductions, which were temporary in nature as well as further strategic investments into UroLift and Manta. Additionally, the acquisition of Z-America is expected to provide a modest tailwind to year-over-year operating margin expansion. Given the relatively higher OpEx cost structure of Z-Medica versus Teleflex, operating margin accretion from Z-Medica will be less than the 50 basis points of gross margin accretion. That takes me to our adjusted earnings per share outlook for 2021. This slide serves as a bridge for our full-year 2020 adjusted EPS results to our full-year 2021 adjusted EPS outlook, beginning with the 2020 adjusted EPS of $10.67. From an operating standpoint in 2021, we project additional earnings between $1.58 and $1.66 per share or an increase of approximately 15%. Our 2021 EPS guidance also assumes the following
Liam Kelly:
Thanks, Tom. In closing, we delivered solid fourth quarter results as our diversified portfolio showed continued improvement relative to the second and third quarters of the year on both the top and bottom lines. Excluding the impact of COVID, we see our underlying business performance as encouraging and while the next several quarters still will have elements of uncertainty, we remain confident in our ability to execute in 2021 and are up and we'll continue to focus on serving our hospital customers and working with our key stakeholders. We are excited about the prospects for our business. We have several revenue drivers including UroLift, Manta, Z-Medica, PICC, Vidacare, EZPlaz and HPC to name but a few. We will manage the business prudently while staying focused to capitalize on the long-term potential of our global product portfolio. In closing, I want to thank our 14,000 employees around the world who continue to manufacture, distribute and support products that are required in the fight of COVID-19 and who came together exemplifying our culture and core values by staying true to our purpose to improve the health and quality of people's lives. As an organization, we remain well positioned to create value for all our stakeholders. That concludes my prepared remarks. Now I would like to turn the call back to the operator for Q&A.
Operator:
[Operator Instructions]. Your first question comes from David Lewis with Morgan Stanley.
David Lewis:
Great. Good morning. Thank you for taking the question, just one on guidance and then a follow-up for Liam on Urology. So, Tom, just to you two little small things on guidance here. Your topline, obviously you've kind of bit of low in the street but you're bracketing the street in bottom line. Assuming that reflects FX and Z-Medica. But can you sort of bridge us there a little bit because it's certainly reflect some opportunity on recovery and then what are you assuming in terms of recovery here as we head into March, now that we're at the end of February? And then a quick one from Liam sure.
Thomas Powell:
So, as we built out our plan for 2021, our assumption is that we see levels in the marketplace in the first and second quarter somewhat similar to what we saw in the fourth quarter and then we expect to follow that recovery beginning in the third quarter, back to what we'd consider more normalized procedure levels in revenue growth rates. And then maybe just help me on the first part of the question again.
David Lewis:
I'm sorry Tom, you're kind of guiding below the position in the top and in line with the street in bottom and I'm assuming that's more FX and Z-Medica financing, but obviously it reflects a lot of room on earnings. I just want to see if you could bridge stay a little bit, make sure that's accurate.
Thomas Powell:
Well, I think that is the way to look at it that as we look at the guidance it does incorporate FX, Z-Medica into our guidance as well as some of the other factors that we've talked about.
Liam Kelly:
And I think, David, if I just could add one comment on the topline guidance, we took a fairly prudent approach we believe to our guidance. September not seems a long time ago but when we identify the potential risk of the increasing COVID cases that had an impact in quarter 4, and in hindsight that was the correct call. Now we were a little bit on an island back then. But most of the market has come around, similarly with the uncertainty still remaining, we have been thoughtful as we look at our 2021 guidance. Some people might say, it's a little bit conservative to expect a recovery in the back half of the year, but I would prefer to be conservative right out of the gaze and to your point if we show it to be overly conservative that should also have an impact not only on revenue but on earnings per share for sure.
David Lewis:
Okay, go head Tom.
Thomas Powell:
If you just think about that EPS bridge when we look at the components of our growth, the growth is really coming from the strength of the operating performance. If you kind of bundle up the change in interest, taxes, shares and foreign exchange. They come pretty close to us to a wash. And then obviously you have a 25 cent pickup from Z-Medica. So, really as you think about what's driving that. It is the underlying performance of the business with kind of the non-operating items being close to wash in the aggregate.
David Lewis:
Okay, super helpful. And then Liam just coming back here to Urology in NeoTract area. The COVID adjusted number for the third quarter is something around sort of 30% which is obviously a little lower than you saw in the second and third quarter. And I appreciate there's a lot of noise in these numbers with COVID, but if I think about sort of that 30% number for the fourth quarter, then I also think about the adding benefit of DTC offsets by resurgence. How should I think about that 30% adjusted number relative to the sort of 40% to 45% numbers we saw in the second and third quarter? Just help us understand underlying momentum and how you see that business into 2021. Thanks so much.
Liam Kelly:
Your math is good. As the impact of COVID, it grew by at 33% and we were really pleased with the performance of UroLift. You got to put it in the context of what happened in the fourth quarter, David. We saw new variance of COVID, we saw COVID cases rising, we saw procedures getting canceled and quite frankly we were really pleased that we actually exceeded modestly, our internal expectations for the product. And I think it had a really tough comp 2 versus the prior year. If you remember last year we grew quite aggressively in the fourth quarter, I think it was up 52% in Q4. So, coming up against a tough comp, I think that was also a factor. And my own view on this is that with the rise in cases, I would have expected UroLift to miss our --. I believe that it didn't do so because of the offset of the DTC which supplemented that. So, I think we're in a pretty good shape with UroLift in regards to the recovery and we feel really confident of where we're at with it.
David Lewis:
Great, thanks so much.
Liam Kelly:
Cheers Mate.
Operator:
Your next question is from Larry Keusch with Raymond James.
Larry Keusch:
Thanks. Good morning, everyone.
Liam Kelly:
Good morning, Larry.
Larry Keusch:
Good morning, Liam. So, I guess, just coming back to UroLift and I know you guys talked a little bit about the philosophy on the '21 guide overall but maybe again talk about how you're approaching the guide for UroLift in '21, that 30% plus. How you kind of thinking about the cadence of that and what's assumed in that for revenues out of Japan. And then I had one on one.
Liam Kelly:
Okay. So, start with the revenue at Japan. Larry, the revenues in Japan are minimal in our guide for UroLift. We do still anticipate that we will get a reimbursement decision as we head into Q2, Q3 and therefore be generating revenues in Japan, but it's fairly minimal within our within our current guide. What we would expect to see, Larry, and as you heard from Tom's prepared remarks with the cadence of revenue in Q1 that would lead you to the overall company revenue being that minus 1, minus 2-ish percent in Q1 because we've seen a rising number of cases after the holidays in January, that continued into February and UroLift would be in the similar bucket. So, the growth that we had in Q4 should be a little bit less in Q1, then you should see a continued recovery as we go into Q2 and Q3 and Q4, thereafter. The UroLift product does have an easier comp in Q2, but every Medtech companies is an easier comp in Q2. So, I think the rubber really hit the road, if I can use that expression, we get into Q3 and Q4 and we begin to ramp back up, COVID cases should be subdued, the vaccine should be rolled out at that stage and we should at that stage, then begin to ramp back up and I think it's, given that the product was flat year-over-year pretty much in 2020 to get an excess of that 30% growth back and that would also indicate that 30% growth on 2019 as well, Larry. So, are in excess, 30% growth versus 2019.
Larry Keusch:
Okay, thank you. That's very helpful and then just the other quick question here is just on EZPlas-you reiterated that $100 million plus market. And it sounds like you went back into another look at that opportunity and still coming out in that range. I suspect that and correctly, if I'm wrong, that you're probably thinking about this as a late '21 FDA clearance. How do you see that revenue starting to impact 2022? How does that develop? Should we be thinking about Military orders being potentially lumpy and you develop the civilian market at the same time.
Liam Kelly:
The beauty by doing a BLA submission, Larry, is that you get access to both civilian and military market. Now we start with the military in 2021 for sure because as you know they helped us develop the product and normal BLA submission is 9 months- approximately were on a fast track. Now, the FDA never tell you when the fast track ends and again in the area of prudence, we have incredibly modest revenue in the 4th quarter of this year for this product and we do expect it to ramp in 2022. Now, to answer your question on the cadence, it's a $100 million market. The military is $25 and so in 2022 will be focused on that military market and again I always caution investors, don't expect the military to place a $10 million order right out of the gate. It would be significantly, significantly less than but as we develop the market and as they roll it out it through special ops, through the CEOs into the general military, then we can pivot to the civilian market. And actually the biggest part of the civilian market, Larry, air ambulances because of the requirements for space and the adaptability of EZPlas to that environment and that's also something that was quite encouraging when we relooked at this market, that it's really two big segments, and then the rest are smaller segment. So, it's easier for us to focus. So, that's how we see it ramping as we go through ' 21 and into '22.
Larry Keusch:
Okay, terrific. Thanks guys. I appreciate it.
Liam Kelly:
Thanks, Larry.
Operator:
Your next question comes from Shagun Singh with Wells Fargo.
Shagun Singh:
Great, thank you so much for taking the question. One on guidance and one on Manta. With respect to guidance, can you let us know what you're assuming for backlog in that guidance by our math, it could be about 9% of sales? And I'm sure some of it's what may flow into 2022 and then on, Manta, could you comment on the lawsuit that was filed by Essential Medical relating to the missed sales milestone and payment by Teleflex following the merger, anything you can share with respect to your positioning, the size of milestone payment and next steps toward the resolution. Thank you for taking the questions.
Liam Kelly:
No, absolutely. I'll start with the guidance question. So, our total revenue guidance of 10% to 11.5% does have assumed in a COVID recovery compared to prior year, but not a backlog or a bolus of procedures coming back other than that in the back half of the year. It's really difficult for us to estimate what that backlog would look like Shagun and also a difficult for us to assess whether hospitals will have capacity to put that backlog through. As we begin to recover, my view hasn't really changed on the geographical recovery. I still think it's going to be led by the Americas and Asia. And I think that Europe is definitely going to be the laggard. It is a source in the healthcare system and the way they're rolling out the vaccine right now does not appear to be in as aggressive as we see in other parts of the world. Regarding the Essential Medical losses that you mentioned, yes, we are aware of clearly and we are confident that we have acted appropriately and believe that the shoes is without merit, to be honest. We intend to vigorously defend ourselves in this matter and Shagun, you're familiar with the Manta product and you're familiar that we've invested heavily behind Manta with both clinical evidence and sales and marketing resources. And the product is a key revenue driver for Teleflex and performed well in the midst of the pandemic, growing over 30% globally in 2020 and growing by almost 90% in the key North American market and our plan this year is to continue to convert over 8% approximately of the large core market this year. And with regards to the question on the milestones. I mean there are contingent payment milestones contemplated in our financials and the total milestones is the matter of this dispute. But as I said we will fight it fairly vigorously. Shagun?
Shagun Singh:
Thank you, so much. I'm all set.
Liam Kelly:
Okay, thanks.
Operator:
Your next question comes from Matt Taylor with UBS.
Matt Taylor:
Hi guys, thanks for taking the question. So, the first one I wanted to ask was since we're coming up here on the launch of UroLift in Japan- you've given some parameters about the TAM at a high level and number of urologists things like that. I was hoping you could be a little bit more granular about the things that you can control in the rollout, like the pace of training, especially given we're still in a little bit of a COVID environment-how quickly should we see that uptake given the constraints that you have in the investment focus that you've?
Liam Kelly:
So, what we've done, Matt, is that we have already preceded the market with market development specialists in Japan and we continue to engage. We've identified the top 20 urologists. Pre-COVID, we actually had a U.S. physician that spoke to Japanese in the country doing some peer to peer training. We also ran a virtual a BPH Summit and had a number of these 20 Japanese urologists. It came it to Reagan's trickle-down economics, but this is a trickle down urologists in Japan where we train at the top of the tree and these 20 our key that we've identified in order then to roll it out to the other urology practices and we have to do a mandated collection of data as part of our reimbursement. So, we will be doing that in the fourth quarter to gather that information and we are really enthusiastic and the other thing that is within our control, Matt, is to add additional sales reps. Now, we take the timing, it is going to work out really, really well for us because, Japan is another America where they are managing the buyers quite well now and they're starting to roll out the vaccine. So, we think as we get into Q3, Q4, we will be requiring access to train. We think the timing is going to work out pretty well for us and give us pretty broad access to the individuals we want to train. So, we did a pretty good about the ground work we've done to date, and we feel pretty good about the identification of the urologists that we need to train and there is a heightened level of knowledge about the UroLift because a lot of these Japanese urologists are very linked to the U.S. Urology Association. So, there is a heightened awareness of the product's availability and a desire to gain access to it. And once we get reimbursement, I think that's when we will really begin to ramp up our efforts.
Matt Taylor:
Thanks. And I just have one follow, as we move into the next couple of years- are we going to see a similar pace of training of urologists in Japan as have in the U.S. by a couple of hundred a year? Can you talk about those plans in the intermediate term?
Liam Kelly:
Yes. So, just remember there aren't many urologists. So, you would imagine it's going to be a little bit less, and also the market is a little bit smaller. And there are specialties in urology practice in Japan. So, if you take the 9,000 urologists, you'd have to imagine that about 5,000 or so are in the specialty we want to. So, that is less than half of what you have in the U.S. So, bear that in mind with the cadence, but in light of that data that's what I would expect a similar cadence and so if we train 400 to 500 in the U.S., you'd expect to train and half of that once you ramp up in Japan.
Matt Taylor:
Okay, got it. Very good, thank you.
Liam Kelly:
Thank you.
Operator:
Your next question comes from Richard Newitter with SVB Leerink.
Unidentified Analyst:
Hi, this is Erin, I'm for Rich. Just a quick one. Potentially, you guys mentioned for the main focus for capital deployment would be M&A. I was just wondering if maybe you could share some color on what kind of areas you're focusing on, and sort of and should we expect any larger deals or the classic tuck-ins?
Liam Kelly:
So Erin, first of all, as Tom said in these commentary. We had a brilliant 4th quarter from the point of view of cash generation and deleveraging. So, we're down below 3 times again, on a net leverage basis. The type of assets first of all, the strategic element of our M&A strategy, our assets that fit within one of our existing channel portfolios are in alliance space. I mean we really like the cath lab for example. So, if we were to move into the neurovascular or peripheral vascular space in that similar call point that would be something that would be attractive. We also like technology that have IP, Z-Medica that we just closed, the IP runs out to 2033. So, that's, we like to protect the businesses. We look for assets that have a clinically differentiated product portfolio. We look for assets that create value in healthcare economics are in synergies in that respect. We also look for products that are sticky but we called sticky that get used over and over again, and again in the Interventional space, in the Vascular space, in the anesthesia emergency medicine space, in the men's health space and in the surgical space, so I think that's the beauty about Teleflex is we are looking in a broad area of places that's why we define these assets and also we're very disciplined in our approach and you can expect us to be continue to be disciplined. I can tell you, our pipeline is pretty full in this environment even in the midst of COVID. It is amazing to me how we're able to get some work done and we were able to close Z-Medica in the midst of COVID and now we're down below 3 and that would be even further reduced as we move through this year. So, we have got firepower and we are always looking and we continue to look right now.
Unidentified Analyst:
Okay great things. And then just another quick one on Manta. You mentioned it grew over 30%. Could you just maybe talk about some of the trend you're seeing with our particular product and then maybe what it's kind of expected in 2021?
Liam Kelly:
So, if you look at 2020. We converted at just over 5% of the market and we're contemplating converting 8% of the market approximately in 2021. So, that's the cadence that -that is in the midst of COVID. But I mean the trends we're seeing is it's being adopted pretty heavily in TAVR procedures, almost 90% of our cases today are still done in TAVR and that's the area, we're focused on. It's a $200 to $300 million market opportunity and we continue to ramp it up and we continue to have sales resources allocated to it and we're also planning to do some clinical work on the product and there are some enhancements that we also want to do on the product to make it even better than it is today. So, all in all we're really encouraged by the progress that we're making and we expect to continue to make progress in this year and into next year, this will be a multi-multi-year growth driver for Teleflex, and as we convert that market we a long runway ahead of us to convert.
Unidentified Analyst:
Great, thanks so much.
Liam Kelly:
Thanks, Erin.
Operator:
Your next question comes from Anthony Petrone with Jefferies.
Anthony Petrone:
Thanks. A couple on UroLift and then I'll have one on Z-Medica. On UroLift, I'm just trying to get a sense of the totality of backlog that's building. Liam, the COVID is still running through so that that's a pressure point and on the demand push side you have DTC and so I'm just wondering if you can quantify the backlog of procedures that are building? And then as we look at the past couple of quarters, is there anything to note on the competitive side- Are you seeing anything competitively from some of the other devices out there, of note? And then I'll have a follow-up.
Liam Kelly:
So yes, first on your backlog question. In the 4th quarter, we started-you may note it included in our assessment of the COVID impact, Anthony, just to be clear, when we assess the COVID impact, the next COVID, it grew by 335% included in that our procedures above the base rate calculation on the year before 2019. So, quarter 4 cancellations above that base rate if you were to put a value on it is around $4 million bucks. So, that might give you an indication of that backlog that those cancelled procedures should come back at some stage when things free up and those are procedures that were booked- the patient was due to have the UroLift procedure done and then either the day before or on the day they cancelled the procedure, one would have to assume because of concern over COVID. So, that's the best benchmark. I can give you in that regard. What was the other part of your question? Anthony, I apologize.
Anthony Petrone:
The other part was on competition, anything of note that you've seen out?
Liam Kelly:
Nothing to report really. Same competitors are in the marketplace. I mean we have now crossed the 250,000 patient mark that have been treated with the UroLift which is a big milestone for us. The other big milestone for us it was an all-time high revenue in the 4th quarter. We've never hit that revenue and you hit that in the midst of a rising COVID pandemic where situation, got a lot worse to me is very encouraging. So, nothing to report new on the competitive front, Anthony.
Anthony Petrone:
And then the follow-ups, would be one on UroLift again would be- can you remind us on medical management, the study referenced today, how many patients do you actually think could shift to UroLift in the medical -- that are currently medical management today and then on Z-Medica there's 3 verticals; trauma, EMS and Interventional where do you think you will see the most synergies at the revenue line, with the existing Teleflex infrastructure? Thanks.
LiamKelly:
So, first on your UroLift. The number of men on medical therapy are the total 12 million men in America, 1.5 million of them have stopped taking the medical therapy and that's our target market of 6 billion, but there are another 7 million men in America that are taking the drug therapy. So, it's a significantly bigger market and that takes the addressable TAM from $6 billion to $30 billion if we were able to attract all of those individuals as well. So, that will give you the size of the scale. With regard to your question on the synergies are where we will be able to leverage Z-Medica from a call point. For definite, the military and EMS call point is a really strong call point for us and Z-Medical have an exceptionally strong trauma call point. So, the synergies between the 2 companies is excellent in the strength that they now call point. And then just consider that Anthony that we have EZPlas, that we just submitted from a BLA coming down the PICC behind that really strong sales channel. So, that's a business with enthusiasm and we're quite encouraged with what we can do in that space.
Anthony Petrone:
Thanks again.
Operator:
Your next question comes from Matthew O'Brien with Piper Sandler.
Matthew O'Brien:
Good morning and thanks for taking the questions. I guess, Liam-I think that's going to get most people's attention this morning is the revenue guide for '21 if you're taken out Z-Medica. It's kind of a 6.5% to 8% growth on a constant currency basis and you easy comps and I understand there is still some COVID impact. Can you break down a little bit what you're expecting from maybe a volume perspective, this year and where that kind of below trend line as far as what people are expecting out of out of Teleflex from organic growth rate or are there other areas where you're trying to be-I know you're trying to be conservative, but more conservative than others-it seems like UroLift might be one of those areas, just any kind of color you can provide on kind of organic guidance that you provided for the full-year would be helpful.
Liam Kelly:
Matt, thank you very much for the question and it really comes down to when do you assume that you're going to see recovery from COVID. Now, we could have been more aggressive in our guidance and assumed that we will begin to see recovery from COVID in Q2. I don't think it's anything to do with volume versus price, versus all the other components, Matt, quite frankly, it's all down to COVID and it's all down to the assumption that you make on COVID. So, if we were to be more aggressive and we would assume going to assume we're going to see a recovery in Q2 as I've heard from some of our peers that they have I think, it would be a more robust revenue story and therefore more robust earning story. As I said to the question, I think David asked-we've tried to be a little bit more prudent and perhaps a little bit more conservative. We still see it's going to be quite choppy as you go through Q1 and Q2. And don't forget the COVID cases in January and early February were much worse than they were in December and late November. And so that's the gating factor, Matt, is your assumption on when COVID is going to recover. And if you look at it and sometimes people want to go back to 2019 and if you look at the back half of 2019, compared to 2021 we're back in that normal, long-term guidance range for Teleflex in the back half '21 versus '19 and again it's all about the assumption-if you assume you're going to recover in Q2 and be aggressive, your revenues is greater. If you assume the back half of the year, your revenue is going to be a little bit less, but you have some conservatism built in and obviously we'll update the investment community when we get to our Q2 earnings release as to what we've seen in that quarter and if it's better, good for investors, great for Teleflex and so on so forth.
Matthew O'Brien:
Got it and then as the follow-up, I'm going to go a little off topic, I know there's a lot of NeoTract and Manta, any class questions but you're spending quite a bit of money on MDR it looks like about $10 million bucks this year. And I know your U.S. story right now, but I'm just curious with that spend, if you know OUS growth just because others can't spend as much and be prepared as you are could be an area of potential upside as we get into '22, '23 and '24 just strategically with all the investments we're making on the MDR side. Is that an area that could surprise some folks as far as the upside goes in a couple of years?
Liam Kelly:
So, I think what you might see happening, Matt, is that the requirements for MDR are significantly burden on someone companies and what you might see, is it be particularly burden on small companies. Now there are a lot of smaller med-tech companies in Europe that I think are going to struggle to continue to comply with MDR and they have to meet the same standards, naturally enough as a larger company like Teleflex. So, 2 things either going to happen. I think those individuals will either decide they don't want to be in particular space is anymore, which will create opportunities for the larger companies or you will see consolidations and M&A opportunities to buy up some of these smaller organizations within Europe. And as you know Teleflex is a serial acquirer, and we will look to take those opportunities as they arise.
Matthew O'Brien:
Thank you.
Operator:
Your next question comes from Matthew Mishan with KeyBanc.
Matthew Mishan:
Great. And thank you, for taking the questions.
Liam Kelly:
Hey, Mark.
Matthew Mishan:
Hey, Liam, I'm just too really on EZPlas. Could you some context on the complexity of the BLA for EZPlas and why it took several years to get through it and what have you kind of worked through with the FDA that would give you confidence for approval in a reasonable timeframe. And then as a follow-up to that on ask-For Z-Medica and EZPlas, would they share the same sales force and how are you thinking about kind of ramping that sales effort.
Liam Kelly:
Yes, absolutely. So, first of all I'll answer the last part of the first. They will share in the same sales force, Matt. And we are combining the Z-Medica and the Teleflex sales force together and that gives us an opportunity to have an even stronger sales force in this channel in order to help us accelerate both Z-Medica and Vidacare and EZPlas when it becomes available. The time that it took for the BLA submission, Matt, was really driven by the fact that this was unchartered waters for both the FDA and for Teleflex. The FDA had never previously approved a biologic of this nature. So, it was unchartered territory for them and for us. And therefore, it took a significant amount of time for them to get through their assessment as we fed them information because to their credit, they work with us, they allowed us to submit partial information as part of the BLA submission. So, that's what allowed us to give them some information, get some feedback, give them more information, get some feedback, and finally, we got the submission done in January. Now why I would think that it should take less than the nine months is number one, we're on a fast track and number two is that had all the clinical data and given us the feedback on the clinical data. We've already given them a significant bolus of data before we submitted the final BLA submission. So, they've had a significant amount of data from us. So, therefore that should help in their assessment and they have also been very cooperative in working with us and the military in moving this through the BLA submission. So, all of those factors would lead me to be quite encouraged by a reasonable timeframe, less than the nine months to get this approved. Excellent. Thank you. Your next question comes from Mike Matson with Needham & Company.
Mike Matson:
Good morning, thanks for taking my questions.
Liam Kelly:
Hi, Mike.
Mike Matson:
I have a question on EZPlas. So, I know there's a lot of folks on the BLA and the U.S. opportunity, but is there any international opportunity for this product.
Liam Kelly:
There is. Mike. Now in the military to 25 million is the majority of that is in the U.S. but there is a portion overseas and of course the civilian market is a global number. So, out of 100 million needs a global number, not just a U.S. number and again it's the same criteria overseas. It's the air ambulances and the military. But as most people would be aware, the U.S. military is one of the more active and larger military organizations on the planet, and therefore it commands a significant portion of that $25 million addressable market.
Mike Matson:
Okay, got it. And then wanted to ask about your PICC business. They used to get a lot of attention but given some of the newer growth drivers hasn't been getting as much, so are you still taking share in that market? Has there been any sort of changes in the competitive dynamics there?
Liam Kelly:
So, I'm very pleased to report, and I think I mentioned in my opening remarks, but the our PICC business in the quarter grew almost 20%. Mike. So, we continue to take share and we continue to be really thoughtful as we grow that business because of our coating technology that allows us to take share from the competitors there. And in a very short period of time of three years, we've moved from being the number three player to being the number two player and we continue to grow aggressively in that space.
Mike Matson:
Okay, thanks.
Operator:
I'm showing no further questions at this time. I would now like to turn the conference back to Jake Elguicze.
Jake Elguicze:
Thank you, operator. And thank you everyone that joined us on the call today. This concludes the Teleflex Incorporated fourth quarter of 2020 Earnings Conference Call. Have a nice day.
Operator:
Ladies and gentlemen this does conclude today’s conference call. Thank you for participating. You may now disconnect.
Operator:
Thank you for standing by, and welcome to the Third Quarter 2020 Teleflex Incorporated Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised, today's conference is being recorded. I would now like to hand the conference over to your speaker today Jake Elguicze, Treasurer and VP of Investor Relations. Thank you. Please go ahead, sir.
Jake Elguicze:
Good morning, everyone, and welcome to the Teleflex Incorporated third quarter earnings conference call. The press release and slides who accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website, and a replay will be available by dialing 855-859-2056 or for international calls, 404-537-3406, passcode 4907865. Participating on today's call are Liam Kelly, Chairman, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks, and then we'll open up the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. Additionally, during this conference call, you will hear management make references to the estimated positive or negative impacts as a result of COVID-19 during the third quarter of 2020. You'll also hear management make statements regarding intra-quarter business performance during the month of October. Management is providing this commentary to provide the investment community with additional insights concerning trends, and these disclosures may not occur in subsequent quarters. With that, I'd like to now turn the call over to Liam.
Liam Kelly:
Thank you, Jake, and good morning, everyone. It's a pleasure to speak with you today, and I hope you're all keeping safe and well. Overall, considering the environment we are operating in, we are pleased with our third quarter performance as it reflected the expected improvement in trends across many of our global product categories, led by a faster-than-expected recovery within our Interventional Urology business, and continued strength within our vascular access product sales. While from a regional perspective, we saw particular strength within the Americas as the pace of recovery in the United States during the third quarter was encouraging. Quarter three revenues was $628.3 million, which was down 4.1% as compared to the prior year period on a constant currency basis but far better than the 12% decline we experienced during the second quarter of the year. The decline in year-over-year revenue is due to the impact of COVID-19, which we estimate caused a net negative impact of approximately $78 million, or approximately 12%. If we were to normalize for the negative COVID impact, we estimate that our underlying business grew by approximately 8% on a constant currency basis, consistent with our quarter two revenue performance. We also saw a significant sequential improvement within our adjusted gross and operating margins from the levels achieved during the second quarter. With our adjusted earnings per share of $2.77 in the quarter meaningfully exceeded our internal expectations. This reflects the continued recovery we saw as we moved through the quarter, coupled with prudent operating expense management. Before I go into more detail on our quarterly financial performance, I am happy to announce that during the month of October, we signed a definitive agreement to acquire Z-Medica, a market leader in hemostatic products. We are pleased to be able to deploy capital for a differentiated product portfolio that leverages existing Teleflex call points and is immediately accretive to our revenue growth rates, adjusted growth and operating margin profile and to our adjusted earnings per share. Turning to a more detailed review of our third quarter results. As I just mentioned, quarter three revenue declined 4.1% on a constant currency basis and 3.1% on an as-reported basis. The decline in revenue was due to COVID-19, which we estimate had a negative impact of approximately $81 million across several global product categories. This was somewhat offset by approximately $3 million of additional revenue within our vascular access and other product categories, which experienced modestly higher-than-expected demand as a result of COVID-19. From a margin perspective, we generated adjusted gross and operating margins of 57.2% and 25.1%, respectively. This translated into a year-over-year decline of 140 basis points at the gross margin line and 190 basis points at the operating margin line. That said, we saw a sequential improvement of 330 basis points on both the adjusted gross and operating margin lines as compared to the levels we achieved in the second quarter. On a year-over-year basis, reduced sales volumes due to COVID was a headwind. However, it was partially offset by our cost containment efforts as we continue to tighten our belts where we deem appropriate in the current environment, balanced against continued investment to sustain our long-term growth aspirations. Adjusted earnings per share was $2.77, down 6.7% year-over-year but ahead of our internal expectations as the business continued to recover during the quarter. When excluding the negative impact of COVID-19 had on our third quarter results, we estimate that our adjusted earnings per share would have grown approximately 13% as compared to the prior year period. Overall, I am very pleased with our financial performance as it demonstrates the resiliency of our diversified global product portfolio. Let's turn to a discussion on our quarterly revenue trends, which will be on a constant currency basis. The Americas delivered revenues of $375 million in the third quarter, which represents an increase of 0.4%. Growth within the Americas was driven by vascular access and respiratory products, which both saw elevated demand driven by COVID. In addition, Interventional Urology was a strong contributor as UroLift continues to be one of the fastest recovering procedures. However, there were offsets with declines in other product categories. We estimate that the Americas would have grown approximately 9%, excluding the impact that COVID-19 had on the region. EMEA reported revenues of $135.7 million in the third quarter, representing a decline of 7%. During the quarter, declines occurred across most product categories as increasing COVID infection rates negatively impacted procedures and results. Adjusting for COVID, we estimate an approximately 3% underlying decline for the region. Turning to Asia; revenues totaled $68.2 million in the third quarter, which represents a decline of 14.2%. However, we estimate that we would have had positive constant currency revenue growth in the high single digits, if not for the impact of COVID-19. Additionally, during the third quarter, we began transitioning a distributor in Japan. When normalizing for both COVID and the distributor change, growth in the region would have been closer to the low double-digit range, consistent with our longer-term outlook. And lastly, our OEM business reported revenues of $49.4 million in the third quarter, which was down 11.8% on a constant currency basis. As we anticipated, during the third quarter, our OEM business saw a lagged impact related to COVID relative to our other businesses. Investors familiar with Teleflex will be aware that our OEM business supplies medical companies with complex catheters and surgical sutures, and the quarter three impact reflects reduced orders from these customers, whose business is tied to non-emergent procedures. Excluding the estimated COVID-19 impact, the business grew roughly 28%, which includes a benefit of approximately 11% from the acquisition of HPC. As it relates to HPC, I am pleased to report that we remain on track with our integration efforts. Let's now move to a discussion of our revenue by global product category. Starting with vascular access. Due to growth within both our PICC and EZ-IO products, third quarter revenue increased 6.8% to $160 million. We estimate that COVID-19 positively impacted the growth rates of our vascular products during the third quarter by approximately 1%. Moving to interventional access; third quarter revenue was $93.2 million, or down 13.5% as compared to the prior year period. The decrease was largely due to the delay in the recovery of certain non-emerging procedures because of COVID-19, along with the negative impact stemming from a catheter recall that occurred during the quarter. We estimate that the recall impacted our business negatively by approximately $4 million. The impact on the recall will continue to linger for the next several quarters as we do not expect to be back on the market with this product until September of 2021. When normalizing for the impact that COVID had on these product lines, we estimate that underlying growth was in the low single digits. Turning to Anesthesia; revenue was $75.7 million, which is lower than the prior year by 14.4%. The revenue decline was the result of lower sales of laryngeal masks, regional anesthesia and airway management products. We estimate that COVID had an approximately 10% negative impact in the quarter, implying mid-single-digit declines for the business on an underlying basis. Shifting to Surgical. Revenue declined by 12.3% to $82.2 million, driven by lower sales of our ligation and instrument product lines. We estimate a 13% headwind from COVID during quarter three, indicating recovery as compared to the estimated 30% COVID headwind in quarter two. Moving to Interventional Urology; quarter three revenue increased by 11% to $81.8 million. We estimate an approximate 29% COVID-19-related headwind during quarter three. Notwithstanding the significant headwind on our growth in quarter three, we are pleased with the path of recovery for this business unit and are also happy with the early impact of our national DTC campaign, which is exceeding our expectations. Additionally, we are encouraged that we trained 120 new urologists in quarter three, moving to a cadence that is consistent with our expectations prior to COVID. And finally, our other category, which consists of our respiratory and urology care products, grew 0.5%, totaling $86 million. In large part, we estimate that growth during the quarter was due to increased demand for certain humidification and breathing products resulting from COVID-19. From a monthly perspective, we note that September outperformed July and August when normalizing for the distributor termination and the product recall within our interventional business. Furthermore, as we have progressed through the first few weeks of October, we continue to see additional modest improvements as compared to last October. That said, due to the significant resurgence of COVID cases globally, and when normalizing for selling days, we expect to see a modest improvement in the constant currency revenue performance during quarter four as compared to the decline of 4% we achieved in quarter three. Tom will provide more details later. That completes my comments on quarter three revenue performance. Turning to some recent clinical and commercial updates. Starting with UroLift; the response to our national DTC campaign is exceeding our expectations. The strategic role of DTC is important as about half of the 12 million men being treated for BPH believe prescription medications are their only solution. Thus far, we are tracking well against the target to generate six times the number of impressions from the regional campaigns in the year ago period. Web traffic has increased over 150% since the launch and another encouraging metric is that multiple urologists are now motivated to get trained on UroLift as a result of patient requests due to the campaign. In addition, while there was likely a nominal impact on quarter three results, we expect the momentum for the campaign to continue building into quarter four and early next year as we turn down the advertising full strength starting in early September. Turning to UroLift 2; since the FDA clearance on July 31, we have begun a market acceptance test and received positive preliminary feedback, including the streamlining of the delivery device triggering mechanism and the reduction of waste. We are also increasing manufacturing levels for the product ahead of the full commercial launch slated for early in 2021. Lastly, regarding the UroLift ATC. We know that the market acceptance test is well underway, and we have received very positive feedback, which indicates that the device is delivering on the intended benefit of enhanced tissue controls when treating challenging anatomies such as obstructive median lobe. Taken together, we see these efforts as helping to build momentum as we seek to further expand our leadership position in BPH. Turning to the next slide on key commercial updates; we recently received an expanded indication for EZ-IO as the device can now be used for up to 48 hours when our alternate intravenous access is not available in both adults and pediatric patients, 12 years and older. While we do not expect a material sales uplift from this label expansion, we are always looking to improve our portfolio based on clinician feedback, and this is a prime example of those efforts. Lastly, I'd like to provide the investment community with a few more details of the Z-Medica acquisition we announced last night. In mid-October, we entered into a definitive agreement to acquire Z-Medica, an industry-leading manufacturer of hemostatic products. Under the terms of the agreement, Teleflex will acquire Z-Medica, for an upfront payments totaling $500 million and up to an additional $25 million upon the achievement of certain commercial milestones. As part of the transaction, Teleflex will also be acquiring certain tax attributes that are expected to result in future tax benefits. We value these tax attributes at approximately $40 million, which we considered when arriving at our purchase price. Z-Medica's hemostatic technologies are helping reinvent hemorrhagic control with cost-effective efficient bleeding control solutions being adopted by markets worldwide. The company offers three main brands
Thomas Powell:
Thanks, Liam, and good morning, everyone. Given the previous discussion of the company's revenue performance, I'll begin at the gross profit line. For the quarter, adjusted gross profit was $359.6 million versus $380 million in the prior-year quarter or a decrease of approximately 5%. Adjusted gross margin totaled 57.2% during the quarter, which is a decrease of 140 basis points versus the prior year period. The decline in gross margin was primarily due to COVID-19 related impacts, including lower sales volumes and higher manufacturing costs along with the foreign exchange headwind. The volume impact was significant for the quarter as the adverse revenue impact from COVID-19 tended to skew toward higher gross margin products including Interventional Urology, Interventional Access and Surgical. In total, we estimate that COVID-19 negatively impacted our adjusted gross profit by approximately $59 million in the quarter. We continue to tightly manage discretionary spending as a means to partially offset the reduced revenue and gross profit resulting from COVID-19 and as a result of the efforts, we estimate that operating expenses were reduced in the third quarter by approximately $22 million. While we expect the actions taken to continue to deliver OpEx savings through the remainder of the year, by far the largest quarterly OpEx reduction was realized in the second quarter. Adjusted operating profit during the third quarter of 2020 was $157.6 million and this compares to $175.3 million in the prior year or a decrease of approximately 10%. Third quarter operating margin was 25.1% or down 190 basis points year-over-year, driven primarily by the gross margin decline. And while our adjusted margins were down in the third quarter as compared to the year-ago period. We are pleased to see the sequential improvement in both gross and operating margins from the lows we experienced during the second quarter. Looking forward, we expect sequential margin improvement to continue during the fourth quarter. Net interest expense totaled $16.4 million, which is a decrease of approximately 14% versus the prior year. The decrease in interest expense primarily reflects reduced average interest rates associated with our variable rate debt, partially offset by higher average debt balances versus the prior-year period. Moving to taxes for the third quarter of 2020, our adjusted tax rate was 7% as compared to 10.3% in the prior-year period. The year-over-year decrease in our third quarter adjusted tax rate is primarily due to a favorable mix of taxable income versus the prior-year period, as well as a higher benefit from stock-based compensation as compared to the prior-year period. At the bottom line, third quarter adjusted earnings per share decreased 6.7% to $2.77. Included in this result is an estimated adverse impact from COVID-19 of approximately $0.60, as well as a foreign exchange headwind of approximately $0.09. Turning to select balance sheet and cash flow highlights, for the first nine months of 2020, cash flow from operations totaled $241.5 million as compared to $289.2 million in the prior-year period. The decrease is attributed to larger contingent consideration payments partially offset by favorable changes in other working driven by higher accounts receivable collections. Overall, the balance sheet remains in good shape. At the end of the third quarter, our cash balance was $347.5 million versus $553.5 million at the end of the second quarter. During the third quarter, we repaid nearly $285 million of our revolver borrowings and restored revolver availability to the full $1 billion. Net leverage at quarter end was approximately 2.6 times. The acquisition of Z-Medica is projected to increase net leverage by less than three quarters of one turn and net leverage pro forma the acquisition remains comfortably below our 4.5 times covenant. Our intention is to finance the purchase of Z-Medica to revolver availability, however, we may choose to permanently finance the acquisition through a future notes issuance. Lastly, we have no near-term debt maturities of material size. Given continued uncertainty surrounding the impact of COVID-19 pandemic on business operations, we are not reinstating financial guidance at this time. However, we will provide the following directional expectations for the fourth quarter. Looking ahead, we continue to expect further sequential improvement in our constant currency revenue performance as compared to what we achieved in the third quarter. However, due to the resurgence in global COVID-19 cases over the past seven to eight weeks, we expect our constant currency revenue growth to be only modestly better than what we achieved during the third quarter. This expectation of a modest fourth quarter improvement excludes the benefit of two additional selling days that occurred in the fourth quarter of 2020 which we estimate would add approximately 3% of additional revenue growth during the fourth quarter. And this expectation also excludes any benefit from the acquisition of Z-Medica as the closing date is not yet determined. And that concludes my prepared remarks, I would now like to turn the call back to Liam for closing commentary. Liam?
Liam Kelly:
Thanks, Tom. In closing, we delivered solid third quarter results as our diversified portfolio showed continued expected improvement relative to our quarter two results on both the top and bottom line. Excluding the impact of COVID, we see our underlying business performance is encouraging and very much in line with our initial expectations. We continue to view the resurgence of COVID globally combined with the willingness of the more vulnerable population to get procedures done as a primary wildcards impacting recovery. While the next several quarters will have elements of uncertainty, we remain confident in our ability to execute as we head into 2021 and are optimistic in our long-term prospects. We, as an organization, will continue to focus on serving our hospital customers and working with our key stakeholders. We will manage the business prudently while staying focused to capitalize on the long-term potential of our global product portfolio. In closing, I want to thank all of our employees who continue to manufacture, distribute and support products that are required in the fight of COVID19, focusing on meeting our commitments to patients, clinicians, communities and shareholders. That concludes my prepared remarks. Now I would like to turn the call back to the operator for Q&A.
Operator:
Thank you. [Operator Instructions] We have our first question from David Lewis of Morgan Stanley. Please go ahead.
David Lewis:
Well, good morning and thanks for taking the question. Liam, it's pretty clear that the business visibility has declined a bit since sort of our conference in September. And I sort of, if you can, want to isolate what you think those factors are, because it sounds like this happened several weeks ago not just the last 48 hours. So, would you say this is just the lack of improvement in hospital census in the US. Is it international markets, specific international markets that are weaker or the OEM business that perhaps had early benefits that didn't have follow through. But I think, given these issues probably have gone on for several weeks versus several days, I want to sort of isolate what particularly you think is the business weakness. And then Tom, I just to be clear on the guidance, we should be thinking sort of low single-digit organic declines in the fourth quarter. And then I had just one quick follow-up.
Liam Kelly:
Okay, David. So, first of all, I think that our underlying business is actually performing very well. If you look at the third quarter, we grew by 8% with a couple of headwinds in there beyond COVID and that 8% excludes COVID. So, if you were to look at our underlying business performance, we're closer to the 9% excluding the Langston recall and excluding the go direct in Japan, which will have longer-term benefits for us. My thinking over the last number of months hasn't changed to be totally frank with you although I am seeing COVID getting worse. When I attended your conference, I think that I was pretty clear that although some of our peer companies were expecting a recovery in quarter four that we did not expect that recovery until early in 2021 and nothing has changed in my thinking around that. Before Tom actually comments on quarter four, I think, it's important that I share with you and the investment community our thinking for revenue growth in the fourth quarter. Many of you familiar with Teleflex will know that we've been seeing, as I said, for the past couple of months that we expect the recovery to be early 2021 rather than the fourth quarter and we continue to believe that to be the case. And as I said, David, nothing has changed in my thinking. But however, because of the significant rise in infection rates globally, we are more cautious now on the pace of the recovery as even compared to a few months ago. In formulating what we believe would happen in the fourth quarter we projected for the modest year-over-year constant currency revenue growth improvements we saw in October for the entire quarter. What we did not factor in was an increase in elective procedures, increased volumes of patients as a result of DTC nor did we factor in the second shift down in relation to COVID, which we think is highly unlikely. We did take into consideration the difficult comparable against quarter four last year where we had a pretty good quarter and we believe this to be a balanced position. And therefore concluded that we would see modest improvement in Q4 constant currency revenue growth as compared to Q3 excluding the billing days. And of course then the billing days will add approximately 3%. So it's really, David, I think what we're seeing in the end markets globally the uptick in COVID that we're seeing in places like France, Spain, Italy, Australia and Southeast Asia and in the key market of the United States. And I have to say I was really encouraged by the performance of our US business in the third quarter where we've turned in North America to a positive growth of 0.4% and that would have been even better if you were to exclude those that one-time Langston call. But I'll let Tom comment on the fourth quarter.
Thomas Powell:
Yes. So, I think, Liam, you touched on the key points, in the third quarter, we - our currency growth was down 4.1%. As mentioned, if you were to exclude the benefit of the extra shipping days and Z-Medica acquisition, we expect the fourth quarter, constant currency growth to be only modestly better than that. So, not to cite a specific number, but we're not thinking there's going to be a significant improvement on the constant currency growth from Q4 - from Q3 to Q4.
David Lewis:
Okay. It's very, very helpful. And just two quick ones from me and I'll jump back in queue. Just, Liam, UroLift that business continues to improve. Can you help to isolate the impact of DTC is having on the underlying business, just given the COVID headwinds, it's kind of hard to see, but do you feel like we're getting DTC momentum from third to fourth. And then just Z-Medica, look, interesting market, very profitable asset, help us understand how you were thinking about valuation and returns. Thanks so much.
Liam Kelly:
Yes, absolutely. So, on UroLift to start with, obviously great seed return to growth. It grew by 11% in quarter three. As I said earlier, we have not, in our quarter four, thinking built in an uplift from DTC. Are we happy with the way the DTC is going? Absolutely. It's going really, really well. Patient response above-expectation, 150% increase in our web traffic. We're actually getting now urologists coming to us looking to be trained on the UroLift because patients are turning up to their practice asking about it. This isn't market research, David, but in this quarter just gone I had conversations with 28 urologists, 27 out of 28 told me that they had patients come into their practice and ask them about UroLift in direct response to what they had seen on either a TV or a web campaign. So, we're very encouraged by that. Regarding the Z-Medica acquisition, let's start with the strategic element that we always look for, does it fit within Teleflex? Yes. The call point is right where we want it to be EMS and trauma. Does it have IP? Yes, very strong IP that runs out to 2033. Are there synergies available because we're putting it into our portfolio? Absolutely. Has it got excellent clinical efficacy? Yes, 150 clinical papers written about it and it's a very sticky product growing into a market that's a $600 million market globally with an opportunity to expand overseas. With regard to the valuation, the few of the key metrics that we looked at, obviously, the multiple on revenues it's in the mid-7s based on forward revenues. But if you exclude the tax attributes, it's just around 7 times. And then more importantly, from an EBITDA perspective in the high teens of 2021 EBITDA and in the lower teens if you go into 2022. We would consider this a scale acquisition similar to Vidacare. We really like the accretion and this is accretive to our top line growth, it's accretive to our gross margins and immediately and creative to our longer-term op margin goals. And it exceeds our internal cost of capital by year four - by the end of year four. And again, a good benchmark for us as you know that's what we try and set ourselves up to is to get to that above our internal cost of capital by year four and our internal cost of capital is in the very high singles, just to be clear.
David Lewis:
Okay. Thanks so much.
Liam Kelly:
Thanks, David.
Operator:
Your next question comes from Larry Keusch of Raymond James. Please go ahead.
Larry Keusch:
Thanks. Good morning, everyone. Liam, I'm wondering if you can, just coming back to UroLift, I guess, two questions on this. How are the trends in procedures progressing when you think about those that are done outside of the hospital versus inside of the hospital? I'm curious if that's continuing to creep upwards. And then how are you thinking about the fourth quarter in terms of the underlying growth for UroLift when you sort of exclude the two selling days. Are you thinking that you will still continue to get sequential improvement in your growth, particularly as the DTC kicks in? And then I've got a couple of quick questions on Z-Medica.
Liam Kelly:
Okay, Larry. So, in regarding to the UroLift in your first question about site of service, we have continued to see a shift from the hospital to outside of the hospital in particular to the office settings. That has moved by around 4 percentage points that have moved from the office to - pardon me, from the hospital to the office. In relation to the recovery that also striking difference to the recovery within the office setting and in the hospital setting. We see the office setting being quite positive in the third quarter compared to pre-COVID levels and the hospital setting is still under the pre-COVID levels from UroLift procedure. So, that's obviously been compounded by the fact that procedures are being moved to the office environment. Regarding moving to the fourth quarter and looking at UroLift in the fourth quarter, as you would be aware, Larry, UroLift has got a significant - had a significant achievement last year. It grew 64.4% last year. So, they've got a really tough comp as they head into the fourth quarter. Notwithstanding that, if I look at it sequentially from an absolute dollar perspective as we go from Q3 to Q4, we would definitely - our expectation will be to see an increased dollar value going from Q3 to Q4. And as I said in my earlier comments, Larry, it's very hard to forecast the absolute impact of DTC in the COVID environment. So, we haven't really built in an expected impact of DTC into the fourth quarter just given the uncertainty around COVID. Now having said that the DTC campaign is going exceptionally well. We will definitely on track to get 6 times - multiple of 60 impressions that we got last year when we did our 18 regional DTCs. As I said, our web traffic is up 150%. The number of patients that are actually going to our doc finder and coming to our call center, I'm not going to tell you the number, Larry, for competitive reasons, but I can tell you it's very encouraging what we're seeing happening out there with the DTC.
Larry Keusch:
Okay. Terrific. And then on Z-Medica, I mean, obviously the valuation is what it was and probably commensurate for a company with that sort of high single-digit growth. But what - how are you thinking about the durability of that growth and sort of why is it durable, I assume up in that high-single digit range. And then the other component of the question is just how are you thinking about sales and cost synergies for the asset and what's built into the deal model? Thanks.
Liam Kelly:
Yes, Larry. Great question. So, from a growth perspective, first of all, these end markets are really in the 4-ish-percent range, 4% to 5%. So, for just turning up, you're actually getting some nice growth, which also helps. The size of the markets are also encouraging. The overall market is about $600 million market globally, $150 million in the EMS, over $300 million in trauma and $125 million in the Interventional. We also have an opportunity and built into our model to do some further clinical work to expand it into cardiac in the future, which will actually expand that market even more. Also right now, the revenue is predominantly generated within North America, in that 80% to 85% of the revenues in North America. So, we believe that expansion overseas is a significant opportunity for us in utilizing our channel, which as you know is a key part of our strategy. The active, we'll do about $50 or $60 million last year, it will do $60 to $70 million this year. And I think a point that shouldn't get lost on the investment community is that the gross margins of this asset are in the low-80s. So, it's a nice opportunity for us to continue our margin expansion and also it shouldn't be lost that the op margins without synergies are accretive to our longer range goals for op margins. And we should be able to generate about approximately $10 million of synergies by year three with this asset which will also help to expand the op margin. And that combined with the growth makes it a very exciting acquisition for us. And I would really look at this, Larry, as another Vidacare. Faster growth, great margins and also us being able to take synergies and continue to expand that overseas and into different areas.
Larry Keusch:
Okay. And just to be clear that $50 million to $60 million in revenues that you referenced and the $60 million to $70 million that's 2019 and 2020. Or is that, what's the right way to think about that?
Liam Kelly:
That's 2020 level...
Thomas Powell:
So, the numbers that Liam referenced our 2019 numbers for the $50 million to $60 million and the $60 million to $70 million is what our expectations are for 2021.
Larry Keusch:
Okay, got it. Thank you for the clarification.
Liam Kelly:
Thanks, Larry.
Operator:
Your next question comes from Richard Newitter of SVB Leerink. Please go ahead.
Richard Newitter:
Thanks for taking the questions. Maybe just to start off, looking ahead into next year some of the catalysts that you have, you mentioned EZPLAZ the BLA pathway now. Can you just maybe give us a sense as to what your anticipated timing is with that regulatory pathway? And then also if you could just touch on timing for UroLift Japan? And just what's going on with Manta underlying trends and specifically the fact that that's maybe in certain types of procedures that are getting done in a more emergent fashion. Can you give us any sense as to how do you think that trajectory might play out into the fourth quarter and into 2021 relative to some of the other parts of your business that you see a little more cautious on?
Liam Kelly:
So, I think that with regard to UroLift Japan, nothing has changed since our last update. We believe that we will get the reimbursement in Q2 and we'll be generating revenue in Q2, Q3 of 2021. So, nothing has changed there in regard to UroLift in Japan. Regarding the BLA, we've made really good progress, Rich, with the FDA. At one stage we were considering an Emergency Use Authorization, I think, the military involvement and this was very helpful to us and now we believe we will have a BLA submission. Do we feel more confident now that we will generate some revenue in 2021? Yes, we do. The timing of the BLA is still to be ironed out with the FDA and once we get the BLA then we are on a fast track and it is very dependent on when they will approve that, but I feel quite encouraged that we will have the EZPLAZ on the market at some stage in 2021. With regard to your question on the Manta. The Manta performed really well in North America in the third quarter, returned to growth in around that 20% mark in the third quarter in North America, and we're very encouraged by that. We - it is a product that gets us access into the hospitals and clinicians are very keen to use the product because it reduces the time to hemostasis. And in today's environment when you're trying to get more TAVR cases through the cath lab, that is very, very helpful. So, we see Manta being one of our key drivers as we go into 2021. One of many I would like to point out, Rich. So, we've got the UroLift, we got Manta, we got UroLift Japan, we now have Z-Medica, we have EZPLAZ coming on stream. So, we've a lot of catalysts for growth as we go into 2021 and it's very encouraging. We just want to get out the other side of this COVID. And just on your comment that we're more cautious than we were. I would say, Rich, we're not, we're equally cautious as we were a couple of months ago. We just don't expect to see the recovery that - the recovery from COVID in Q4. We expect it to be nearly 2021 and nothing has changed in our thinking around that. But thank you for the questions.
Richard Newitter:
Got it. And just on that last one, if I could follow up, Liam, in the last part on 4Q. So, I guess, what I'm hearing is, you have some things that could be incrementally positive relative to what's in your internal outlook like DTC benefit. But you're also being cognizant that surgeries are occurring in the US and then more formidably internationally. So, maybe we should just view that as you haven't necessarily seen that impact on elective procedures or hospital trends yet with October was trending better than the third quarter trend. But you're going to leave out any incremental benefit beyond October or actually you're dialing and the potential that things take a step back and that's why is the improvement has been bigger in 4Q.
Liam Kelly:
So, I think, the way - it's a great question, Rich. I think, the way we look at it, look, September adjusted was minus 2% roughly. And we saw a sequential improvement in the first few weeks of October. And actually the first few weeks in October were pretty much flat year-over-year. But despite this positive trend in October and given the rise in cases in COVID and the tougher comps, we still expect modest improvement in Q4 versus Q3. We haven't built in, as you said, the DTC maybe we're being overly conservative. But this is as clearer picture as we have right now and if the recovery continues in Q4 as we haven't built in, Teleflex is going to benefit from that and we will accelerate. If we go into a second last time, which I don't expect it will be worse than we expect. But I think we're trying to, Rich, take a balanced and prudent approach to the fourth quarter. And what we see in front of us right now, as I said a few times, my crystal ball is cloudier than it's ever been with two months still left to go in a quarter. But I'm encouraged by what I saw in October, Rich, to be candid. We're up against a really tough comp in the last two months, and we have not built in a continued improvement in recovery, we basically taken what we've seen in October and prorated that in the last two months of the quarter. Now, if it continues to recover, it will be better, there is no doubt about it.
Richard Newitter:
Got it. And just, Liam, just to be clear, the 4Q guidance that you provided that was all excluding any contribution from Z-Medica, correct?
Liam Kelly:
Yes, I mean, there are things that will help us reach, so Z-Medica being one that you point out. FX should work in our favor that will help us if procedures start to come back a little bit better that will help us. So, yes, you're correct. And we did not include Z-Medica and also, we've got two additional billing days in the fourth quarter which should add about 3%. So, there are green shoots out there and nice opportunities, but we don't want - as we sit here right now, we want to be absolutely as candid as we can with the investment community.
Richard Newitter:
Thank you.
Operator:
Next question is from Shagun Singh of Wells Fargo. Please go ahead.
Shagun Singh:
Thank you so much for taking the question. So, just a point of clarification there on Q4. So, should we expect you to be positive in Q4 with the addition of the two extra selling days? And then couple of questions on UroLift, I believe, you did start seeing the first set of patients come in in September and October. Are you willing to share with us what kind of volume lift you're seeing from this initiative? And then as we think about Q4, and thank you for all the color there, you do have a full quarter of national DTC initiative that you said you haven't dialed in 6 times the ad impressions year-over-year. And on an underlying basis year-to-date, you have been delivering about 40% year to date. So, is that a reasonable floor to expect for Q4? Thank you.
Liam Kelly:
So, I think, Shagun, you're correct. We're very encouraged by the underlying performance of all of our businesses and UroLift is no exception. The underlying performance has been fairly consistent at 40%. We have not built in the DTC into the fourth quarter quite simply, Shagun, because it's very hard for us to determine where the patient came from when they go to the urology practice and because of the uncertainty in relation to the COVID - increase in COVID cases around the United States. With regard to the sharing on the DTC initiative, for competitive reasons, Shagun, I don't think it would be wise for us to share many of the specifics, but I can tell you that the number of patients that are actually clicking and calling our call center is very encouraging. If every one of them and that's - it's not going to happen, but if every one of them turned into a procedure that would be quite encouraging for us as an organization. And as we go into the fourth quarter, as we said earlier, we declined by 4% in the third. We expect a modest improvement over that and then we expect to pick up another 3% from billing days. FX should work in our favor if it stays where it is today. And that's where we see the fourth quarter landing.
Shagun Singh:
I got it. That's helpful. And then if I could just ask a question on 2021, I think, you just mentioned that you expect next several quarters of uncertainty related to COVID. What does that mean for 2021, consensus is looking for about double-digit growth in 2021 versus 2019, I believe it's still below pre-COVID levels. So, what is your reaction to that? And then on the margin side, how should we think about it? And when do you expect to get to your LRP goals? Thank you for taking the questions.
Liam Kelly:
Thanks, Shagun. Well, we would have - to answer the most part of that question, we would have to get out the other side of COVID. There's so much uncertainty out there with COVID. Are we encouraged by the underlying performance of our business? Absolutely, we are encouraged by the underlying performance of our business. Do we think we have a number of catalysts for growth? Yes. Have we just add another one today? Yes, we've added Z-Medica. Do we believe that once we get back out the other side of COVID that Teleflex will be in a strong position? Yes. With regard to our longer-term goals, are there right goals for Teleflex? Absolutely, they are. And nothing has changed in my thinking on that either. They are the right goals for Teleflex. And it's not a question of if we get to them, it's a question of when. But in order to give the investment community clarity on that, we need to come out the other side of COVID. We need to have a vaccine or a fall-off in the level of the condition to a certain level that consumer confidence is high and hospitals are able to get a higher throughput of patients. Even though everyone was expecting at the beginning of this COVID crisis that there would be almost like a super boom in Q4 where hospitals will put on extra capacity, we haven't seen that in October. And I don't think we're going to see it in November and December. And I don't want to predicate the fourth quarter on a super boom procedures coming back into hospitals because quite frankly, I can't see it happening.
Shagun Singh:
Thank you so much.
Operator:
Next question is from Anthony Petrone of Jefferies. Please go ahead.
Anthony Petrone:
Hi. Good morning, everyone. I hope everyone's doing well, staying healthy. Two questions for you, Liam. And then I have a follow-up for Tom. The first two questions are in UroLift and I'm wondering if you could just give us an update on total urologists trained to date? By our math, it's about 2,800 or so, maybe a touch higher than that. And then ultimately, when you look at the pool of 12,000 urologists in the US, maybe just the refresh on what the peak target penetration in there is. A quick one also on UroLift would be anything on the DOJ investigation. And then I'll ask the follow-ups. Thanks.
Liam Kelly:
All right, Anthony. So, on DOJ, absolutely no update on that and I would advise the investment community not to expect an update for a number of quarters as they're still focused on that single practice. With regard to the number of urologists, Anthony, we've changed, your math is pretty good. We're in around 2,900 of the 12,000 trained. And what's very encouraging for me is that we trained 120 urologists in the third quarter, which is right back to our normalized run rate pre-COVID training urologists. And I genuinely, well I know that the DTC is helping with that because we know urologists are coming to us because their patients have come into their office asking them about UroLift. The other part of your question regarding the 12,000 urologists, how many do we need to train? What's the magic number? In our research as we broke down our champions, what we've discovered is the champion, the average urologists see 75 BPH patients. But what we've discovered is whether you see 50 unique BPH patients a month or whether you see 150 unique BPH patients a month, you have the same opportunity to become a champion. And a champion is a urologist who does six procedures or more a month. So, we have to train all of the - pretty much all of the 12,000 urologists to get this 100% penetrated. And that's what makes it so exciting, Anthony, because it's such a big opportunity. As we train more urologists and we make this a standard of care for BPH, it is a massive market for us to grow into.
Anthony Petrone:
Great. And then - that's helpful. And then the two follow-ups real quick here. We noticed that just the APAC trends 2Q to 3Q actually decelerated, again, the view is that they are a little bit ahead of the curve with COVID. So, maybe just to touch on what actually happened in APAC in 3Q. And then Tom, just in terms of the last slide on the deck for the margin outlook. The total pre-tax savings $85 million to $98 million is the overall target. I think, you exiting 2019, it was $26 million of that was realized. So, maybe just an update on where you guys sit on realizing the expected savings from restructuring? Thanks again.
Liam Kelly:
Yes, Anthony. I'll take the APAC one, obviously APAC was impacted by our decision to take the Japan business direct. So, if you normalize for that, it was about 11%. If you normalize for COVID, it was in those very low double digits but about 11%, slight degradation, and that was really driven by an increase in COVID cases in India and Southeast Asia, and a resurgence in Australia. We are a little bit unique, I guess, insofar, as that we are more exposed to Australia. It's a bigger part of our APAC business than it would be for other companies and similar to India. So, those are the key drivers for APAC. And I'll let Tom answer the other part of the question.
Thomas Powell:
Well, sure, on the restructuring programs, I'd first like to just say that despite COVID outbreak, the program still continues to track towards plan and schedule. So, we feel very good about that. In fact, one of the initiatives have moved up and we're going to be able to realize some savings earlier over the next couple of years than was previously expected. In total, the savings are $85 million to $98 million, as you mentioned. About 25% of those were realized by the end of 2019. And then we expect to realize a fairly significant amount in 2020 and 2021, little less in 2022 and then a fairly substantial amount in 2023. So, as far as the cadence, we're going to - what's remaining, you're going to see about half of that realized in 2020-2021 and the rest in the next three years. Is that helps?
Anthony Petrone:
Thank you.
Liam Kelly:
Yes.
Operator:
We have our next question from Matt Mishan of KeyBanc. Please go ahead.
Matthew Mishan:
Hey, Liam, based on Z-Medica, can you take a step back and explain why the technology is differentiated versus competitive products and the clinical evidence that's driving the growth?
Liam Kelly:
Yes, absolutely, Matt. And there are a multiple clinical papers written on the 75 peer reviews and really it comes down to some of the key factors. If you look at some of the human data 88.3% successful hemorrhagic control, success rates are right up there. And if you look at the military did one the Combat Gauze, higher success rate of achieving hemostasis at 89% for the - and 100% for the second application compared to standard gauze. So, you're looking at 89% and 100% hemostasis compared to standard gauze at zero percent and 13%. And, again, in the area of blood loss in trauma significantly less blood loss after packing was seen and this is the QuikClot plus where you can actually put it internally and obviously reduction in blood loss. And there is also an external use study and radial access that shows shortening the hemostasis by 94 minutes to TR - compared to TR band. So, it's really hemostasis and time that is the focus of the clinical peer reviews. And the product outperforms the standard of care that is used today in the market and is being adopted rapidly in EMS and trauma centers around the United States, in particular, and we want to expand that overseas.
Matthew Mishan:
Okay, excellent. And then just the last one, how are you accurately measuring the COVID impact on your business?
Liam Kelly:
So, I'm actually going to ask Tom, if you don't mind, to answer that because Tom has been working with the finance team and the business units to work through that.
Thomas Powell:
Okay. Well, let me walk you through it. And I - we will admit it's not a perfect estimation, but we, as a business, wanted to understand the impact, so that we could understand our trends, I've spent quite a bit of time focusing on that. And so I'll share with you our approach. So, essentially, we began with the budget and then we made adjustments for known deviation from the budget. Plus or minus trends versus a budget prior to COVID to see how different businesses were performing, changes in competitive dynamics, canceled programs and events and CMA programs. We also looked at back order status and any changes there that could impact the results. We looked at distributor ordering patterns, as well as even customer communications regarding order push outs. And so we used all of this data to come up with kind of a number of adjustments that we attributed to COVID. And then the difference is essentially from budget was attributed to the COVID impact here, net of all of these adjustments. And we used some other approaches to triangulate around to just validate that. As for margins, once we had established the revenue impact, we could then apply our variable manufacturing costs. We included COVID-related manufacturing increases whether it was social distancing, PP&E, attendance et cetera. And we made adjustments for such factors such as sales commissions, as well as the OpEx cost savings initiatives. So that was our approach. I think we've taken a really hard look at it, but recognize that it isn't a perfect science, but rather our best estimation of the impact. And I hope you find itself.
Matthew Mishan:
Understood. And thank you for the detail.
Thomas Powell:
Yes.
Liam Kelly:
Thanks, Matt.
Operator:
Next question is from Matt O'Brien of Piper Sandler. Please go ahead.
Unidentified Analyst:
Hey, good morning, guys. This is Drew [ph] on for Matt. Thank you for taking the questions. I wanted to follow up a little bit on the Z-Medica transaction, obviously, congrats on getting your hands on pretty, some pretty interesting products there. Maybe you could speak to a little bit on both the potential sales force efficiencies, it seems like they could be pretty meaningful. And then how long will be the process of training your sales force before you can roll it out to the vast majority?
Liam Kelly:
Yes. So, we actually see the sales force synergies as the synergies the Teleflex brings because of our channel into the EMS space. So, if we look at that, we have a very strong sales organization that sells the EZ-IO, sells laryngeal masks as a whole plethora of products into that EMS and military call point and we've very strong relationships with the military, which is, as you can see from their co-sponsor of EZPLAZ product to get it into the marketplace. So, we see that really as an opportunity for us to accelerate the growth into that key call point. And then thereafter to expand within the other areas of trauma. As I've said in earlier in the call, total synergies by year three, we expect in the region of $10 million and that comes from a variety of areas and is an opportunity for us. But we want - this is a growth asset and our thinking here is that we will continue to invest behind this in the channel into the future in order to ensure that we will have more sales people on the ground in the combined organization than we did as Z-Medica as a stand-alone. And we will also look to expand into our channel overseas. We also have a direct call point into some of these key areas overseas and opportunities there to expand this portfolio. So, it's a very nice acquisition high single-digit growth, great margins both on the gross and operating margin. Great clinical data and very long IP. So, it's well protected and growing into a $600 million market.
Unidentified Analyst:
Okay. That's very helpful. And then my follow-up is, on the performance in your Other category, I think, that includes your respiratory business, which benefited from COVID early on. I mean, it looks like it kind of returned to flat this quarter. Is the right way to think about that that some of the tailwinds from COVID early on are starting to die down? Or is there the potential for that to pick up a little bit again as you know the severity of the current COVID outbreak? Thank you.
Liam Kelly:
Yes. So, what you would expect that would happen is, as you get over the increase in the curbs [ph] of COVID as we did in Q3 exactly as you pointed out, Drew, you would anticipate that those businesses will get back to more normalized levels. As you head into Q4 and as you see COVID beginning to increase again, you would expect that both our respiratory and our vascular businesses would benefit from that increase. Normally we would anticipate that respiratory would benefit from a strong flu season. My own view is that the flu season this year is irrelevant because of COVID and hospitals will protect themselves to have supply of these products in the fourth quarter in case the resurgence continues and in case that we go into a second lockdown. I don't think we're going to go into a second lockdown, Drew, I think the hospitals have really learned how to treat patients with COVID. And they're also segregating areas in the hospitals, if not entire hospitals, to move COVID patients to them, so they can continue to conduct procedures even in the midst of a second COVID outbreak.
Unidentified Analyst:
Thank you.
Operator:
Next question is from Matt Taylor of UBS. Please go ahead.
Unidentified Analyst:
Hi, guys. This is Young [ph] for Matt. I'll just ask one question in the interest of time, that's kind of a high level one. But I'm just wondering when do you expect the operating environment can get back to normal on the other side of COVID, for example, after vaccine is widely distributed. I realized the pathway there is pretty lumpy, tough question, but just kind of curious about your thoughts there. If we can achieve 75% herd immunity with the vaccine, can business trends return to pre-COVID level potentially even before that or one or two quarters after that? Just want to get your high-level thoughts on that.
Liam Kelly:
Well, if you look at quarter three, what we saw was things begin to turn back to normal until we saw the upswing in COVID cases starting in Europe and then spread to North America. So, we were in quarter three as we went through it getting to, especially the first couple of months of quarter three. And then you get into the third month of quarter three and we saw COVID cases begin to rise again. I think that the answer to the question is, first of all, get out beyond COVID in in Q1, Q2 next year then get a vaccine. And I think it's also a little bit psychological that people feel that there is a vaccine out there. So, therefore they will feel more comfortable going back and getting procedures done and they won't be as concerned about a second or a third wave as it would be probably at that stage. So, I think, the vaccine is key, I think that the virus itself weakening and managing it better is also key as we go into the first half of 2021. And I would be very hopeful that if we get through the first half of 2021 and early in 2021, we'll begin to start come out the other side of this COVID pandemic and have a vaccine available and begin to return to some sense of normalcy. But again my crystal ball is as clear as yours is right now, everyone's crystal ball is a little bit murky.
Unidentified Analyst:
Okay, thank you. Very helpful.
Operator:
Next question is from Dave Turkaly of JMP. Please go ahead.
Dave Turkaly:
Great, thanks. And not trying to beat the dead horse here, but you mentioned France, Spain, Italy, Australia and the US, the case increase. I'm just curious if anecdotally you've seen any evidence of elective deferrals happening in any of those areas currently. I know what happened in the past, but I - I know there's more cases, but I'm just curious, are you seeing that currently today?
Liam Kelly:
So, I mean, the key market here is the United States. And if you look at the United States and if you look at pre-COVID and after COVID and our best benchmark really is the UroLift business. The states that are - I'm looking at the bigger states now where you carry a lot of your volume that are still below pre-COVID levels are, Massachusetts, New Jersey, South Carolina. Those that are rebounding back very strongly and above that are North Carolina, New York and Illinois, just three examples. So, what you've got is a mixed bag. So, in the United States we haven't seen the deferral of those procedures. But what we have seen is in places like India and indeed in Australia, in the third quarter, we saw the deferral of some procedures and hospitals pushing them back. So, yes, we did see it in some of the geographies. It will be interesting to see now what we will see in places like France and Spain. I think what they're going to try and do is keep patients flowing through the hospitals because the bigger human tragedy here could be people not getting procedures, and therefore, having a very bad outcome in the future because they didn't get that critical procedures that were needed because they were afraid of COVID. So, I think, that's a bigger human tragedy in the making. If we don't keep our hospitals open and keep patients flowing through them. And I think the other thing that you're seeing, as I said earlier, is that patients feel more confident going to the office and the ASC than they do in the hospital and we're seeing especially with UroLift the office setting, doing quite well compared to the hospital setting getting back to above pre-COVID levels in the office in its entirety within the United States. I hope that answers your question as accurately as I can.
Dave Turkaly:
No, that's great. Thank you. And that's it for me. Thank you.
Liam Kelly:
Thank you.
Operator:
Next question is from Mike Matson of Needham. Please go ahead.
Mike Matson:
Thanks. So, just on UroLift 2, can you give us your latest thinking on the impact to margins and growth, if any, of the product and then the timing to when you're fully converted to UroLift 2?
Liam Kelly:
Yes. So, the margin is still the same. It will move the UroLift margins from the mid-70s to high-70s, you should think about it getting about 4 full percentage points on that business. And last year that business did about $300 million. We'll begin the roll out early in 2021. I think that it's easy for the urologists to adopt this. The early indications that we have from our pre-market work has been really, really positive. The docs really like the way the product works, it's easier to use same grade outcomes, same - easier to use and same visibility, same everything. I'm really glad we took our time to change the visibility factor on this because it's coming back with the real positive feedback from the urologists. So, as we begin to roll it out in 2021 as we get into 2022, we should be able to have a large portion of the North American market converted.
Mike Matson:
Okay, thanks. And then just on the OEM business, you had mentioned this lagged impact because of the customer kind of destocking or whatever that's occurring, but is that largely over do you think or would that continue into the fourth quarter?
Liam Kelly:
So, I think, we will definitely see an improvement in the OEM business in the fourth quarter. What happens there Mike is, obviously, we make products for other companies, branded companies, all of which you will know, and you probably covered a large proportion of them. And what we've seen is, as their elective procedures fall off and there was a lag to them placing orders in our OEM business and we expected this to happen. This is not unexpected, we knew the OEM was going to be impacted by COVID a quarter later than the rest of our businesses. What we've also seen in some of these key companies destock as they are shoring up their capital and making sure that they're managing their free cash flow. So, we've seen some of them destock, you can only do that for a certain period of time. So, I would expect to see our OEM business begin the path to recovery in Q4.
Mike Matson:
Great. Thank you.
Operator:
Next question is from Chris Cooley of Stephens. Please go ahead.
Chris Cooley:
Good morning, and thank you for taking the question. I'll just ask one at this point. But, Liam or Tom, I'd appreciate if you could provide some additional color on the fourth quarter. Not so much in terms of what you excluded like Z-Medica, the extra selling days, but what you contemplated in that guide from the perspective of hospital and most notably the US hospital. Curious if you're assuming heavier inventory carries through calendar year-end improvements in throughput in terms of procedure growth. To the extent that it's there. Just kind of some of those exogenous variables would like to get your perspectives on. Thank you so much.
Liam Kelly:
Yes, Chris. Thank you for the question. What we did was we looked at what we saw in October and we pretty much projected that into the remainder of the year. Now, - and we did not assume an uptick in procedures. We did not assume a procedure recovery, and we may be too conservative here. But we do not anticipate getting back to pre-COVID levels in Q4. We still think that's going to be in early 2021. Now, October for the first four weeks of October look pretty reasonable, I mean, we were pretty much flat in the first few weeks of October. We do come up against a tougher comp when we get into November and December. Chris, you will know that, for example, the UroLift grew by 54% last year and our overall business performed very well in the fourth quarter of last year. So, we took that into consideration. We did not anticipate a further lock down. We anticipated that we would see COVID being well managed. We had seen in the month of October the upswing in the COVID cases, so that initial upswing was in our thinking when we laid out what we expect to happen for the fourth quarter. Those are the things we included and those that we excluded. And of course we excluded DTC, we included the - we excluded the billing days and they will add about 3%, we excluded FX; that should help us. We excluded - I'm sorry, I'm going back to the exclusions rather than inclusions, Chris, but we did also exclude Z-Medica that hopefully we'll close in the fourth quarter.
Chris Cooley:
Thank you, and congratulations.
Liam Kelly:
Thanks, Chris.
Operator:
There are no further questions at this time. I will now turn the call over to Jake for any closing remarks.
Jake Elguicze:
Thanks, operator. And thank you to everyone that joined us on the call today. This concludes the Teleflex Incorporated third quarter 2020 earnings conference call.
Operator:
Good morning, everyone. This is Henry and I will be your conference operator today. At this time, I would like to welcome everyone to the 2020 Second Quarter Teleflex Incorporated Earnings Conference call. [Operator Instructions]. Now I would like to turn the call over to our first presenter for today, Treasurer and Vice President of Investor Relations, Mr. Jacob Elguicze. Sir, you may begin the conference.
Jacob Elguicze:
Thank you, and good morning, everyone, and welcome to the Teleflex Incorporated second quarter 2020 earnings conference call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website, and a replay will be available by dialing 855-859-2056 or for international calls, 404-537-3406, passcode 1778009. Participating on today's call are Liam Kelly, Chairman, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks, and then we'll open up the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. Additionally, during this conference call, you will hear management make references to what the estimated positive or negative impacts were as a result of COVID-19 during the second quarter of 2020. You will also hear management make statements regarding intra-quarter business performance during the month of July. Management is providing this commentary to provide the investment community with additional insights concerning trends, and these disclosures may not occur in subsequent quarters. With that said, I'd like to now turn the call over to Liam.
Liam Kelly:
Thank you, Jake, and good morning, everyone. It's a pleasure to speak with you today. Before I get into the details of our quarterly performance, I'd like to offer my condolences to anyone who's been impacted by the coronavirus, as well as my sincere thanks to all the healthcare workers who put themselves at risk to battle COVID-19 each day. I'd also like to take a moment to recognize the Teleflex employees around the world. These past few months have been far from normal, and our employees continue to inspire me as they have stepped up in extraordinary ways to ensure that we are able to provide our products to the hospitals, clinicians and patients who need them most. Thank you. Now on to our Q2 results. When you take into consideration the global escalation of the COVID-19 pandemic, we are quite pleased with our second quarter performance as it significantly exceeded our internal expectations and reflected improvements in underlying monthly revenue trends for the product categories most impacted by the postponement of non-emergent procedures, most notably, Interventional Urology, Interventional Access and Surgical. Q2 revenue was $567 million, which was down 12% as compared to the prior year period on a constant currency basis. The decline in revenue is due to the negative impact from COVID-19, which we estimate caused a net negative impact of approximately $130 million or approximately 20%. If we were to normalize for the negative COVID impact, we estimate that we grew our underlying business by approximately 8% on a constant currency basis, or near the high end of our initially provided 2020 full year constant currency revenue growth rate range. From an earnings per share perspective, like revenue, our adjusted EPS of $1.93 in the quarter also significantly exceeded our internal expectations. This reflects the recovery we saw in monthly procedures as we moved through the quarter, coupled with prudent operating expense management. Lastly, at the end of the second quarter, we also commenced our workforce reduction plan, which will allow us to capitalize on programs designed to drive further long-term profitability. This latest effort is primarily focused on streamlining certain sales and marketing functions within EMEA as well as certain manufacturing operations within our OEM segment. Turning to a more detailed review of our second quarter results. As I mentioned, quarter two revenue declined 12% on a constant currency basis and 13.1% on an as-reported basis. The decline in revenue was primarily due to COVID-19, which we estimate had a negative impact of approximately $144 million across several global product categories. This was somewhat offset by approximately $14 million of additional revenue within our vascular access and other product categories, which experienced higher-than-expected demand as a result of COVID-19. From a margin perspective, we generated adjusted gross and operating margins of 53.9% and 21.8%, respectively. This translated into a year-over-year decline of 380 basis points on the gross margin line and 340 basis points on the operating margin line, as reduced sales volumes and unfavorable revenue mix impacted by COVID were major headwinds. These headwinds were partially offset by our cost containment efforts as we continue to tighten our belts where we deem appropriate in the current environment, balanced with continued investment to sustain our long-term growth aspirations. Adjusted earnings per share was $1.93, down 27.4% year-over-year, but well ahead of our internal expectations as the business started to recover during the quarter. And while I never like to see declines in year-over-year revenue and profitability, I am very pleased with our overall financial performance as it demonstrates the resiliency of the diversified global product portfolio we have built over the past few years. Next, I thought it would be helpful to provide some context regarding how we saw COVID-19 impact our second quarter results. During the second quarter, we estimate that COVID-19 was a headwind to revenue across Interventional Urology, Surgical, Interventional Access, Anesthesia and OEM. Somewhat offsetting these headwinds were positive tailwinds within Vascular Access and other, as hospitals continued to have strong demand for those types of products. Netting these two impacts, we estimate that COVID was a $130 million headwind or an approximate 20% detractor from our 2Q revenue growth. Importantly, we were encouraged that after a difficult April, the key global business units impacted most negatively by COVID improved sequentially as we moved through May and June. Specifically, Interventional Urology year-over-year revenue was down approximately 79% in April. It was down approximately 30% in May and then down approximately 8% in June. Turning to Interventional Access. Year-over-year revenue declined approximately 30% in April, approximately 28% in May, and then it was down approximately 2% in June. And finally, our Surgical business experienced year-over-year revenue declines of approximately 34% in April, 31% in May and then approximately 21% in June. As we anticipated and stated on our last earnings conference calls, as various states and countries began to reopen, Interventional Urology led the recovery. But we also saw improving trends within Interventional Access and Surgical as most hospitals have restarted non-emergent procedures in earnest. And while our business our businesses have not yet to fully return to normal, we are encouraged by our trends into July, which largely reflect further improvement in the business. That said, while we view the latest trends as encouraging signs of a continued global recovery, we remain cautious as select hospital capacity has come under pressure in certain geographies as COVID-19 cases have reemerged. As a result of the uncertainty associated with the scope and duration of COVID-19, we made the decision not to reinstate our 2020 financial guidance at this time. Let's now turn to the quarterly results. I will begin with a review of our reportable segment revenue. And unless otherwise noted, the growth rates I will refer to are on a constant currency basis. The Americas delivered revenues of $312.5 million in the second quarter, which represents a 16% decline. Growth within the Americas was driven by Vascular Access and respiratory products, which both saw elevated demands driven by COVID. However, this was more than offset by declines in other product categories. We estimate that the Americas would have grown approximately 8% excluding an estimated 24% impact of COVID on the region. Importantly, as we progressed throughout the second quarter, Interventional Urology saw sequential improvement from April to May and then from May into June with a positive momentum largely carried forward into July. While we are encouraged by this recovery, we are cautious due to the recent outbreaks and reduced non-emergent procedure capacity in states, including Texas and Florida. EMEA reported revenues of $131.6 million in the second quarter, representing an 8% decline. Like the Americas, growth drivers included vascular and respiratory businesses, which benefited from elevated demand related to COVID-19. However, like the Americas, growth in these product categories was outweighed by declines elsewhere. Adjusting for COVID, we estimate approximately 1% underlying growth for the region. Turning to Asia. Revenues totaled $67.1 million in the second quarter, which represents a decline of 7.8%. However, we estimate that we would have had a positive constant currency revenue growth in the low double digits consistent with our long-term outlook for the region if not for the impact of COVID-19. And lastly, our OEM business reported revenues of $55.8 million in the second quarter, or 70 basis points recurring on a constant currency basis. As we anticipated, during the second quarter, our OEM business saw a lagged impact related to COVID relative to our other businesses. Investors familiar with Teleflex will be aware that our OEM business supplies device companies with complex catheters and surgical sutures. And the 2Q impact reflects reduced orders from these customers whose business is tied to non-emergent procedures. Excluding the estimated COVID-19 impact, the business grew roughly 25%, which includes a 16% benefit from HPC. As it relates to the acquisition of HPC, the integration efforts are well under way, and I am very pleased with how the business is performing under our leadership. Let's now move to a discussion on our revenues by global product categories. Consistent with my prior comments regarding our reportable segments, commentary on global product category growth will also be on a constant currency basis. Starting with Vascular Access. Due to the growth within both our central venous catheter and EZ-IO products, Q2 revenues increased 8.8% to $164.9 million. We estimate that COVID-19 positively impacted the growth rates of our vascular products during the second quarter by approximately 5%. Moving to Interventional Access. Second quarter revenue was $82.6 million, which is lower than the prior year by 20.3%. The decrease was largely due to the delay in the performance of certain non-emergent procedures because of COVID-19. We estimate that underlying growth was in the mid-single digits, adjusting for an approximate 24% COVID-19 headwind. Turning to Anesthesia. Q2 revenues were $64.9 million, which is lower than the prior year by 23%. The revenue decline was due to lower sales of laryngeal masks and regional anesthesia products. We estimate that COVID had an approximate 22% negative impact in the quarter. Shifting to Surgical. Revenue declined by 28.4% to $67.3 million, driven by lower sales of our ligation portfolio and instruments. We estimate a significant 30% headwind from COVID during 2Q. However, as we stated earlier, we have seen sequential improvements on a monthly basis since April lows. Moving to Interventional Urology. Q2 revenue decreased 40.9% to $40.1 million. We estimate an approximate $58 million COVID-19-related headwind during 2Q. Unfortunately, the cancellation of elective procedures impacted this product line more than any other in our portfolio. That said, because the UroLift procedure is primarily performed in an outpatient lower acuity setting, we envisioned that UroLift will be one of the first types of procedures that would be performed once the United States began to reopen, and that's exactly what we have seen with sequential improvements from April to May, May to June and from June into July. And finally, our other category, which consists of our respiratory and urology care products grew 5.4%, totaling $91.4 million. In large part, we estimate the growth during the quarter was due to increased demand for certain humidification and breathing products resulting from COVID-19. If we were to exclude the estimated benefit from COVID-19, we estimate that the other category would have been down slightly as compared to the prior year period. That completes my comments on quarter two revenue performance. Turning to some clinical and commercial updates. Our body of clinical evidence for UroLift continues to expand during the second quarter with data from two studies presented at the AUA 2020 Virtual Science Event and data from another study published in the Canadian Journal of Urology. The first study presented at the AUA 2020 Virtual Science Event in May was a meta-analysis of patients' sexual function following treatment with the UroLift System versus medical therapy, while the second study was an analysis comparing patient outcomes from the large Real World Retrospective study to those found in the L.I.F.T. pivotal trial and the P.U.L.S.A.R. urinary retention trial. The results from the first study compared sexual function outcomes of 849 sexually active men who received daily treatments with an alpha blocker, 5-alpha-reductase inhibitor, either alone or in combination and 190 men from combined clinical studies of the UroLift System at 12, 24, 36 and 48 months. Results from the analysis showed that patients treated with the UroLift System experienced significant improvement in ejaculatory function and erectile function at 12 and 24 months post treatment. Patients also reported significant improvement in overall sexual satisfaction through 48 months post treatment. In contrast, none of the medical therapies significantly improved patients' erectile or ejaculatory function at any time point and some therapy significantly reduced function. Additionally, the UroLift System significantly outperformed all three medical therapies across all-time points at preserving patient ejaculatory function. Only patients who received UroLift System reported significant improvement in overall satisfaction in sexual life. The second study compared patient outcomes from the large Real World Retrospective study to those found in the L.I.F.T. pivotal trial and P.U.L.S.A.R. urinary retention trial, which studied catheter-dependent BPH patients. Results from analysis showed patients from all groups experienced similar absolute IPSS scores at all-time points following treatment with the UroLift System. Analysis also revealed equivalent safety profiles among non-urinary retention and urinary retention patient groups from the Real World study when compared to corresponding groups in control studies. Finally, the results indicated that the majority of retention patients became catheter independent at the end of the study. Lastly, a study comparing patient experience of those treated with the UroLift System to those who received tissue ablation by a steam injection was published in the Canadian Journal of Urology. The study compared 53 non-retention patients from two U.S. sites. Early postoperative results showed positive differences for patients treated with the UroLift System compared to resume, including better sexual function outcomes, less interference in daily activities and higher patient satisfaction. We continue to extend our body of clinical evidence which should help to get the fast followers on board with UroLift, which is quickly becoming the standard of care as the leading minimally invasive surgery to address a massive global market opportunity. Turning to the next slide on key commercial updates. We received FDA clearance for the UroLift advanced tissue control or ATC system. This is an instrument that optimizes UroLift for the treatment of obstructive median lobe. We plan to hold a market acceptance test for this product in late 2020. And while we estimate that between only 5% and 10% of the market have an obstructive median lobe, this enhancement demonstrates our commitment to invest in R&D to expand our leadership position in BPH. In addition, as we began to see a recovery in the performance of non-emergent procedures as the second quarter progressed, we made the decision to launch our pilot national DTC campaign in early July, building on the success of our regional DTC efforts. The national campaign will run from July to December, and the strategic role of DTC is important, as about half of the 12 million men being treated for BPH believe prescription medications are their only solution. Regarding the timing. Our regional digital DTC efforts indicated strong patient engagement in June, along with positive sentiment from clinicians, both of which gave us confidence in the July launch. While it's still early, the initial patient response is very strong, with significant increases in call volumes and web traffic spikes to urolift.com versus the weeks prior to launch. Physician feedback has also been very positive. Indeed, UroLift is leading the way in BPH, and this is the first time in recent years that a BPH brand is reaching patients directly in a meaningful way. Additionally, we submitted the UroLift two for 510(k) FDA approval at the end of the second quarter. And lastly, I would like to congratulate the interventional urology team on surpassing 200,000 patients treated with UroLift. While this is a significant milestone, with DTC in the U.S., approximately 2,700 urologists trained and major market launches scheduled over the next few years, we have only scratched the surface in treating the approximate 100 million men globally estimated to have BPH. Turning to some clinical updates within our Interventional business unit. We recently began enrolling for a prospective single-arm IDE study, targeting 150 patients across approximately 15 sites within the U.S. to evaluate the performance of Teleflex coronary guidewires and specialty catheters in chronic total inclusion percutaneous coronary intervention procedures. The study will evaluate the performance of the entire range of Teleflex complex PCI products in chronic occlusive coronary disease, which is the most demanding PCI environment. We view PCI as a high-growth space within the Interventional Cardiology segment, and we will continue to invest in areas that will improve our weighted average market growth rates over time. Overall, we continue to invest in clinical and commercial catalysts that will help to sustain our upper single-digit revenue growth aspirations in a normalized environment. That completes my prepared remarks. Now I would like to turn the call over to Tom for a more detailed review of our second quarter financial results. Tom?
Thomas Powell:
Thanks, Liam, and good morning, everyone. Given the previous discussion of the company's revenue performance, I'll begin at the gross profit line. For the quarter, adjusted gross profit was $305.8 million versus $376.6 million in the prior year quarter, or a decrease of approximately 19%. Adjusted gross margin totaled 53.9% during the quarter, which is a decrease of 380 basis points versus the prior year period. The decline in gross margin was primarily attributable to COVID-19-related impacts, including unfavorable product mix, lower sales volumes and higher manufacturing costs. The mix impact was significant for the quarter. The adverse revenue impact from COVID-19 tended to skew toward higher gross margin products, including UroLift, Surgical and Interventional Access. In total, we estimate that COVID-19 negatively impacted our adjusted gross profit by approximately $100 million in the quarter. Because of the reduced revenue and gross profit resulting from COVID-19, we continue to look for opportunities to help mitigate the earnings impact while at the same time, maintaining Teleflex's ability to rapidly rebound once non-emergent procedures recover. As such, operating expense reductions tend to be focused on categories that are non-revenue-generating and are discretionary in nature, including savings from meetings, travel and management variable and performance-based compensation. As a result of the efforts, we estimate that operating expenses were reduced in the second quarter by approximately $35 million. While we expect the actions taken to continue to deliver OpEx savings through the second half of the year, by far, the largest quarterly benefit will be realized in the second quarter. Adjusted operating profit was $123.9 million as compared to $164.7 million in the prior year or a decrease of approximately 25%. Second quarter operating margin was 21.8% or down 340 basis points year-over-year, driven by the gross margin declines and loss of operating leverage, partly offset by the reduction in operating expense. For the quarter, net interest expense totaled $15.5 million, which is a decrease of approximately 24% versus the prior year quarter. The decrease in interest expense primarily reflects reduced interest rates associated with our variable rate debt, partly offset by higher average debt balances in the second quarter of 2020 versus the prior year period. During the quarter, we took steps to further improve our liquidity by issuing $500 million of 8-year senior notes at 4.25%. The proceeds obtained from the note issuance were used to repay revolver borrowings. Moving now to taxes. For the second quarter of 2020, our adjusted tax rate was 15.8% as compared to 13.4% in the prior year period. The year-over-year increase in our adjusted tax rate is primarily due to less benefit from stock-based compensation as compared to the prior year period. At the bottom line, second quarter adjusted earnings per share decreased 27.4% to $1.93. Included in this result is an estimated adverse impact from COVID-19 of $1.18 as well as a foreign exchange headwind of approximately $0.04. Now I'd like to discuss our recently introduced workforce reduction plan. During the second quarter of 2020, we committed to a workforce reduction plan, designed to improve the profitability by streamlining certain sales and marketing functions in our EMEA segment and certain manufacturing operations within our OEM segment. We estimate that we will incur aggregate pre-tax restructuring charges of between $10 million and $13 million, consisting primarily of termination benefits, which will also result in future cash outlays. We expect that most of these charges will be incurred prior to the end of 2020. Once the plans are fully implemented, we project annual pre-tax savings of between $11 million and $13 million, and we expect the savings will begin in 2020. I will also provide a summary of all of our ongoing restructuring and cost savings programs. Including the latest workforce reduction plan, savings across all programs are expected to be between $59 million and $72 million. Approximately 1/2 of the savings are expected to be realized in 2020 and 2021 and in the remaining 1/2 over the period 2022 through 2024. As such, we have good line of sight to non-revenue-dependent margin expansion in the foreseeable future. This also adds to our confidence that our prior LRP financial targets of 6% to 7% revenue growth, 60% to 61% gross margin and 30% to 31% operating margin remain the right goals for Teleflex. And the question is only when, not if we achieve them. Turning quickly to select balance sheet and cash flow highlights. For the first half of 2020, cash flow from operations totaled $134 million as compared to $157.3 million in the prior year period or a year-over-year decrease of $23.3 million. The decrease is attributed to a $10 million pension contribution made in the first half of 2020 and was not made in the first half of the prior year and a $54 million increase in first half 2020 contingent consideration payments versus payments made in the first half of 2019. Overall, the balance sheet remains in good shape. At the end of the second quarter, our cash balance was $553 million versus $406 million at the end of the first quarter. Net leverage at quarter end was approximately 2.6 times, providing comfortable headroom when compared to our covenant, which requires that we stay below 4.5 times. Lastly, we have no near-term debt maturities of material size. And that concludes my prepared remarks. I'd like to now turn the call back over to Liam for closing commentary.
Liam Kelly:
Thanks, Tom. Before closing, I'd like to make you aware of a matter that will be disclosed in our 10-Q filed today. In June, we began producing documents and information responsive to a civil investigation demand received by one of our subsidiaries, NeoTract from the U.S. Department of Justice through the United States Attorney's Office for the Northern District of Georgia seeking documents and information pertaining to communications with and certain rebate programs offered to a single NeoTract customer in relation to the DOJ's investigation of that customer. Subsequently, in July, the DOJ advised us that it had opened an investigation under the Civil False Claims Act with respect to NeoTract's operations broadly in addition to the customer investigation. We maintain policies and procedures to promote compliance with the Anti-Kickback Statute, False Claims Act and other applicable laws and regulations. And while the company intends to cooperate with the government's investigation and request for information, we will vigorously defend our programs, practices and conduct, which we believe are lawful and in accordance with industry best practices and standards. We cannot, at this time, reasonably predict the duration, scope or the outcome of this matter. In closing, we delivered solid second quarter results as our diversified portfolio helped to dampen the impact COVID had during April, and procedures have started to improve month-over-month in May, June and into July. However, it remains difficult to predict the shape and duration needed to measure the path to recovery. And while the next several quarters will have elements of uncertainty, we remain confident that our long-term underlying fundamentals remain solid, and we still see great opportunity over the long-term to serve our key constituents. We, as an organization, will continue to focus on serving the vast majority of hospitals that remain open for procedures while also monitoring closely, those select regions that are temporarily shut down. We continue to adapt our business and opportunistically shift toward a greater emphasis on digital tools, both internally as well as with our customers. We will manage the business prudently, while staying focused to capitalize on long-term potential of our global product portfolio. I would like to finish by again thanking all our employees who continue to manufacture, distribute and support products that are required in the fight of COVID-19, focusing on meeting our commitments to patients, clinicians, communities and shareholders. That concludes my prepared remarks. Now I would like to turn the call back to the operator for Q&A.
Operator:
[Operator Instructions] And your first question comes from Mr. David Lewis of Morgan Stanley. Your line is now open, sir.
David Lewis:
Good morning and thanks for taking the question. Just Liam, two for me this morning. The first question, obviously surrounds the most important debate, which is NeoTract. So a couple of questions there. Did NeoTract grow year-over-year in July? And there are a couple of trends sort of to vet out in July. One would be resurgence, did you see an impact of resurgence? And then obviously, the DTC campaign began. So was there an impact from resurgence or any benefit from DTC and as I started, did NeoTract grow in July? And then a quick follow-up.
Liam Kelly:
Okay, David, thank you very much for the question. To cover the NeoTract trends that we saw, obviously, we saw a big decline in April, down 80%, down 30% in May, and then we saw continued improvement in June when we were down 8%. As we went into July, we continued to see positive momentum with the UroLift product. And I am pleased to report that it did turn green in July as we continued to see practices reopen. We did see practices close in certain geographies, and it's really county by county in certain geographies, in particular, in Texas and Florida. But to counterbalance that, you had practices in New York, New Jersey and in Pennsylvania reopening, so it was a counterbalance. With regards to your question on the DTC, it was almost too early to see an impact of DTC as of yet and have patients scheduled. But we did see significant foot traffic on the test that we ran. We actually had to increase the number of people that we had in the call center taking the calls, and we saw a significant uplift in the traffic that went to urolift.com as a result of the initial DTC. It is early days, David, but very positive signs for the UroLift product.
David Lewis:
Okay. So UroLift grew despite resurgence in July and the impact of DTC probably is more impactful later in the quarter, it sounds like. And then I'll just ask my last one here, Liam. Just most peers aren't giving a COVID-19 impact, you did. It implies organic growth kind of 7%, 7.5%, but on a very challenging comp. So there was like several points of momentum acceleration. Just as you look across your business broadly here in the second quarter on an underlying basis, where do you think that source of strength or that momentum improvement was most focused?
Liam Kelly:
Thanks, David, I would just like to make a comment that we give that level of detail and clarity to the investment community to give them more transparency into the business and how we saw the COVID would impact us. As we went through the quarter, I think that the momentum came in a few areas. We continue to take underlying business within Interventional, Urology and the UroLift obviously continues to perform well. Ex-COVID, we would estimate that the UroLift was grew at around 44%. So a good solid performance from the UroLift ex-COVID. Obviously, the OEM business underlying without the acquisition performed very, very well. And EMEA was slightly underperformed, but there was a distributor order that moved out within the quarter. So if I took that into account, I was actually reasonably pleased with the EMEA performance as well. And of course, our Vascular business continues to grow and take share as to their Interventional business. So it was pretty broad-based, David, but those are the main drivers.
David Lewis:
Great, thanks so much.
Liam Kelly:
Thank you.
Operator:
Your next question comes from Larry Keusch of Raymond James. Your line is now open, sir.
Larry Keusch:
Okay. Liam, you've obviously learned a lot about the business resiliency during the pandemic. So I'm curious, how are you thinking about sort of the durability of growth into the future? And are there areas that you've sort of now been able to see where you think you might be able to actually invest more to either continue that growth rate or perhaps even accelerate it?
Liam Kelly:
Yes, thanks, Larry. And I think that, yes, we have learned a lot about the durability of a broad-based portfolio that is not overly exposed to procedural volume. Clearly, areas for accelerated growth and investment in the future will be around the UroLift product. As I said in my prepared remarks, we've only scratched the surface of penetration. And we with the UroLift two 510(k) now submitted, once we get that approved, we will be able to continue our progress in Japan. We are doing our clinical trial in France, we see an opportunity further down the pike in China. And we've only scratched the surface in North America. We still have only trained 2,700 out of the 12,000 urologists that are in the United States. So significant growth in the American expansion overseas. Beyond that, you will have heard on the call today that we continue to invest in clinical evidence broadly not beyond even the Interventional Urology business unit and the UroLift product, with the CTO trial that we announced that we're proceeding within the Interventional. We think that that's an opportunity to expand the market potential of our product to an additional 70,000 cases, about 7% or 8% of PCI cases are in that CTO area. So we think that's a nice opportunity. And also, we will be continuing to invest behind our penetration into PICCs, in particular, in North America and continue to take share within that portfolio. So those are broadly the areas where we see investment in the future. And DTC, it's very early days, Larry. But if DTC does what we think it can do, I see no reason why that wouldn't continue over a multiyear period.
Larry Keusch:
Okay. So it sounds like you're feeling confident in the durability of the growth of the company as you come out of COVID? And so that's sort of question 1B. And then perhaps for Tom. Again, if I just sort of think about Liam's response here and the opportunity to do more investment, I know you talked about the LRP objectives are still sort of the right goals for the company. But should we think about margins perhaps taking a little bit longer to get to those objectives, if you have opportunities to invest? And I guess the second part of that question is just as you think about the cost savings, that you've realized during COVID and you're running more efficiently. I know you said some of that will start to come back as you start to spend. But is there are there cost savings here that you can have that are more durable as you look out in time?
Thomas Powell:
Okay. Well, certainly, as we think about the investment for the future in margins, I would just first say, with regard to the margins, we'll reinforce the point that we believe the 60%, 61% gross margin, 30%, 31% operating margin are the right targets. We believe this business has got the capability to get there and to continue to drive margin expansion. The real question for us is, is the timing. And a key component of that margin expansion is related to mix, and a key component of the mix is UroLift. So as that business continues to perform, and we see a better trajectory, we'll get a better view toward the timing related to getting to those margin targets. As we think about investment, we'll balance growth with margin objectives, and we'll continue to look for ways to drive efficiency, so we can fund the investment. But what we don't see is a major investment that's taking us away from those targets. In fact, what we see as we invest behind UroLift is a very good margin story. It's one of our highest gross margin operating margin opportunities out there. So we see that as a potential opportunity to continue to drive margin expansion through investment. I would say with the cost savings, a lot of what we've taken out this year is related to if you think about it, we're holding open positions, in fact, recruiting is difficult during this time frame, we've got T&E, we've got some reductions in management compensation. So as we think about going to the future, a lot of those costs will come back into the system. I would say that as we look at what's durable in the cost savings, certainly, the new organizational restructuring will drive some permanent savings. But a lot of what we've taken out this year as far as cost reductions, our costs that we expect to put back for the most part into the system as we get into 2021.
Larry Keusch:
Thanks guys. Appreciate it.
Thomas Powell:
Yes, thanks, Lawernce.
Operator:
Next question comes from Mr. Richard Newitter of SVB Leerink. Your line is now open, sir.
Richard Newitter:
The first one on UroLift and the July recovery comment. I'm just curious where you are seeing resurgence of cases, and I think you said that there were some shutdowns, is that actually from the supply side, that the providers are shutting down or is it more on the patient side, just a lower willingness to go and seek out treatment? I asked that just basically to get a feel for how in-office and ASC based in-office on hospital setting procedures might potentially fare during a more informed and understood kind of virus situation. And do we actually see the same kind of impact that we saw the first go around? So if you could answer that within the context of July, that would be helpful. And also just indicate how much is backlog worked down versus new office to generate growth?
Liam Kelly:
Thanks, Rich, for the question. From what we see, the it's really the provider closing down in particular counties and states based on instructions from the state itself. And what we have seen in our research, and we did a research of our customer base. And what we have learned from that is the customers our patients actually feel quite comfortable going to all three sites of service because the procedure is such a short procedure, one hour minimally invasive. And I think it's important that you don't need a general anesthesia. So there's no aerosol gas being introduced to the patient while they have the procedure; it's some lidocaine or maybe even a block, whichever they decide to use. And what we've seen is that patients have been comfortable going to all three sites of service for the procedure. What surprised me in all transparency is the willingness of a patient to go to the hospital. And they felt as confident going to the hospital as they did feel going to the office and the ASC. That to me was a little surprise. But beyond that, we're very encouraged by the flow-through of patients that have gone through the hospital. I spoke to a CEO of a big system recently, and he is concerned that if patients don't go to the hospital, that there will be a bigger healthcare issue. And he actually coined the phrase. This is not my phrase, now this is this person's phrase. He wasn't calling it the pandemic, he was calling it the pan didn't, didn't have this procedure, didn't have that procedure. And that individual's concern was that, as I said, there's going to be a longer-term impact if people don't go to the hospital. But I am encouraged by the willingness of patient to attend to have UroLift procedures.
Richard Newitter:
Okay. And then I just want to make sure thank you for all the quantification of your best attempt to quantifying COVID. I'm getting to about a just under 7%, 6.6% organic kind of growth rate for 2Q if you back out about 1.5% contribution for the inorganic HPC component. One, am I thinking about that correctly? And then two, I think you had mentioned that there might have been some orders that were pushed out. So maybe if you could quantify how much that impacted the quarter? And would that have lifted that organic growth rate, assuming it's correct?
Thomas Powell:
Yes. You've given a bit too much credit for the M&A, Rich. So our organic growth would have been higher than that. And on the orders that were pushed out, it was in Europe, it was in the region of about $3 million to $4 million. You should that's what was pushed out into Q3 by some distributor orders. I mean, I think if you just step back and look at our overall growth, I think in the first quarter, ex the impact of COVID, we grew just over 8%. Second quarter, we grew at 8%. And I would also like to remind the investment community that we have two additional days in quarter four as a catalyst in the back half of the year. And obviously, having convened with the DTC and UroLift, our fastest growing assets we also see that as a catalyst in the back half of the year, and we were very encouraged to see the UroLift product turn green in July.
Richard Newitter:
Thank you very much for the question.
Thomas Powell:
Thanks, Rich.
Operator:
Next question comes from Shagun Singh of Wells Fargo. Your line is now open, sir.
Shagun Singh:
I was wondering what do you think July trends imply for Q3? Could you achieve flattish growth in Q3 year-over-year? And do you still expect normalization in Q4? And then I have a follow-up.
Liam Kelly:
Shagun, thank you very much for the question. I think as we go through July, we're quite encouraged with the notable modest improvement that we've seen across the board in July for our overall businesses. I would not like to mislead the investment community to say that the for Teleflex as a whole in the first few weeks of July is in a positive growth state because we are not. It is still a negative but a better outcome than we had seen. It's really difficult for me to give guidance beyond even in the third quarter should go we pulled our guidance for the full year just because of the uncertainty around COVID. But I will tell you that I and management feels a lot better here, as we sit here today in the back end of July, as we did when we sat at the back end of April on our first quarter earnings call, and we feel much more confident that it's beginning to look more like a V-shaped type recovery rather than anything else rather than you. I would also say that in consultation with CEOs of hospitals, they have robust plans, should there be a second wave to work to try and prevent what happened in the first wave with the cancellation of procedures because, as I said earlier, of the ongoing impact it will have for people.
Shagun Singh:
That's really helpful. And then just as a follow-up on the national pilot DTC campaign. Our checks have suggested that volume lift could be in the range of about 20% or so. Is that a fair range, given what you've seen in some of the DTC regions? And then I was just wondering what discussions you are having with urologists so that they can be strategically prepared for the additional patient flow when it occurs?
Liam Kelly:
Yes. So we had a broad outreach to urologists before we began the DTC. What we normally asked of urologists is to have some flex capacity within their practice, so that as we as patients click on our website or call our call center, that we can direct them to urologists with capacity. A key point is that a patient needs to have a call back from a clinician in within the 24, 48 hours. And then another key factor is the need to have the appointment scheduled within that, call it, four to six weeks. It's very early days for us to assess the impact on the uptick, Shagun. I wouldn't doubt your methodology. You've been pretty accurate in the past with what you've done. So I don't want to go there, but it's too early for us to make a real determined assessment of it. We would know more after another quarter of continuous DTC. And the DTC campaign will run from July, assuming that there isn't a second significant resurgence in COVID will run from July through to the end of this year, and that is our intention. And the initial launch also, Shagun, was limited in so far as we focused on two of the four television channels that we were going to focus on that just to test our call center. And I'm really glad we did that because the volume upsurge was such that we needed to add additional resources to that call center. I would also say that the feedback from the patients who have seen the ad and the urologist community has been incredibly positive.
Shagun Singh:
Thank you so much.
Operator:
Your next question comes from Mr. Matt Taylor of UBS. Your line is now open, sir.
Matt Taylor:
So the first one I wanted to ask was you talked about these underlying growth rates ex-COVID in the second quarter that were encouraging. I guess, could you talk about how you estimate this because I imagine that's pretty challenging? And are you continuing to see this kind of strong high single-digit underlying growth rates for the company through July?
Liam Kelly:
So the I'll cover the July growth rate, and I'll ask Tom, if you don't mind, to cover the methodology. He's probably better poised to do that. So the growth rate for July, for an overall company, improved. So defacto, I think we could conclude that the overall growth rates were at least consistent with Q2. So that's to answer your question on the growth rates in July. Obviously, there's a lesser impact of COVID in July. So one would anticipate, if that is the case, your growth rate overall as a company should improve. Now again, as I said earlier, I don't want to mislead the investment community. We're not, as an overall company, in positive growth yet through the first few weeks in July, but it's an improving trend. And Tom, if you wouldn't mind covering the methodology?
Thomas Powell:
Sure. So just to talk about the big picture approach and there are certainly nuances by each business unit. But essentially, we began with our original budget and forecast projections. And then we adjusted for known deviations. So for instance, we took a look at the trends prior to the outbreak of COVID, how we were performing versus our projections. We also took a look at changes in competitive dynamics, whether there was an issue where we could take share or giving up share. We looked at programs that got canceled, events that were canceled, CMA programs that were postponed and quantified that. Took a look at other items such as backorder status and changes there, distributor ordering patterns, communication from customers talking about pushed orders. And so essentially, it was a trend analysis adjusted for known activities. And the difference between the budget adjusted for those activities was all attributed to COVID. Now we recognized the methodology wasn't precise, but what we wanted to do, as an organization, better understand what we thought the impact of COVID was and we thought as the investment community, we would share that information with you as well.
Matt Taylor:
Right. Okay. And then I was hoping you could spend a minute on the DOJ investigation. Do you think that is going to impact the trends in the NeoTract? It sounds like it started with one customer, but it's a little bit broader now. Are you seeing any commercial impact from that?
Liam Kelly:
So as you can appreciate, Matt, it's very early days, and we're limited to what we can say at this time. I don't believe we will have seen any commercial impact now. As you're probably aware, these things tend to go on over a period of time. So I would expect that situation to stay as it was. As it progresses, we will obviously provide further updates as and when appropriate. I just want to say, Matt, I want to reiterate that we maintain policies and procedures for more compliance with the Anti-Kickback Statute, False Claims Act and all other applicable laws and regulations. And we will cooperate with the government's investigation and any request for information. We will also vigorously defend our programs, our practices and our conduct, which we believe are lawful and in accordance with industry best practices and standards.
Matt Taylor:
Great. Okay, all right. Thanks, Liam. I'll let some others jump in. Appreciate it.
Liam Kelly:
Sure. Thank you.
Operator:
Your next question comes from Mr. Matthew Mishan of KeyBanc. Your line is now open, sir.
Matthew Mishan:
Maybe how coordinated is the DTC campaign with your urologist partners in the various regions? And it just seems like the business you may be driving for those partners could be very positive. How do you see that relationship and channel evolving for you guys going forward?
Liam Kelly:
So obviously, we have a wonderful relationship with the urology community. Sometimes one would be a bit concerned when you run a DTC campaign mass that you could have set your customer. And obviously, we would never wish to do that. So we have communicated broadly with urology community about the campaign. And our goal is to improve patient outcomes. I think our urologist goals are to improve patient outcomes. We cannot improve patient outcomes unless they know about the best procedure for benign prostate hyperplasia. So I think it's a real partnership. I think the urologist community are supportive of what we do. We know they're supportive from the feedback that we've gotten from them. I think it's really good for patients. It's good for the health ecosystem because it will reduce the overall cost to treat a man with BPH if they're on pharma. The crossover point is two to four years, whether it's a generic or a branded product. So therefore, I think this is a good practice for the overall ecosystem and raises awareness and gets great patient outcomes with no sexual dysfunction with the best treatment on the marketplace for BPH.
Matthew Mishan:
Okay. And then Liam, just to switch gears a little bit. Say we are in a slower growth type environment exiting 2020 into 2021. What do you think that means for M&A more broadly? And what do some of the more attractive assets kind of do in that kind of environment?
Liam Kelly:
So I think that as we head into 2021, my theory would be that the opposite would be the case from a growth perspective because you'll be in a real you'll have a much easier comparable as you go through Q1 and Q2. And I was originally thinking that you would get a bolus of additional procedures in the back half of this year, we'll wait and see if that actually happens. That may not happen until you get into 2021, just with some of the resurgences. As it impacts on M&A, I think that from an M&A perspective, especially for companies like Teleflex, our strategies toward M&A won't change. We're looking for new innovative technologies. We really like technologies that are obviously single-use that have great patient outcomes, that have great healthcare economics argument, that expand our growth and margin profile as an organization and that at the end of the day, improve patient outcomes. So I don't think it's going to make a big difference for companies like Teleflex and the assets we're looking at. And obviously, at the end of this quarter, our balance sheet, as Tom outlined, was in really good shape. We're at 2.6 times net leverage. And I think the M&A environment, as we see a positive recovery to COVID should spell opportunity for companies like Teleflex.
Matthew Mishan:
Thank you.
Liam Kelly:
Thanks Matt.
Operator:
Your next question comes from Mr. Anthony Petrone of Jefferies. Your line is now open, sir.
Anthony Petrone:
And I hope everyone is doing well and staying healthy. A few questions on UroLift, just some follow-ups here and then quick ones on MANTA and EZPlaz. And so just on UroLift, can you provide the update on number of docs trained? And if you can, what percent of patients coming from drug therapy? Liam, you mentioned the study obviously benefits versus drug therapy, and that's the largest pool to draw from. So what is the update there on patients coming from drug therapy to UroLift? And then ultimately, where does that go, all right? How big can UroLift be in the BPH setting? And then I'll have the follow-ups after.
Liam Kelly:
Okay, Anthony. And we're all well, thank you, and I hope all is well with you as well. So with regard to the training, obviously, we had trained just shy of 120 urologists in Q1. As we went into Q2, we trained again just shy of 70 urologists. Now just to give you a little bit of context around that, Anthony, we only trained seven urologists in April because most of them were short. So you can appreciate that as we've gone through May and June, we've ramped back up to near-normal training regimes on urologists, and we're getting access to urology practices to train urologists. So that's been a real positive for us.
Anthony Petrone:
That's helpful. And then just on capture from drug therapy. I mean is there any way to sort of determine where that is at this point?
Liam Kelly:
The straight answer, Anthony, is there isn't. It was much easy in the early days when we were running the pivotal trial. I don't think it's changed that much. Around 70% of our patients either come from the drug dropout or the drug category. And I don't believe and anecdotally, when I talk to urologists and when I hear from the Interventional Urology team, they tell me that hasn't changed much over the time.
Anthony Petrone:
Helpful. And then real quick, just the MANTA rollout, anything new there and EZPlaz BLA submission, just as it relates to time lines and how COVID has impacted that?
Liam Kelly:
Absolutely, Anthony. So MANTA, again, was obviously impacted by the COVID. Just to give you some context, MANTA in our key market, in North America, it declined by almost 40% in April. But then in May and June turned positive. So as we started to get access to the hospitals again and continues with that positive trend through July. So I'm quite encouraged by what's happening there. With regard to EZPlaz, we've had a couple of phone calls with the Department of Defense and the FDA. We have not, as of yet, had that face-to-face meeting. That should happen in this quarter. Just because of COVID, we have been able to even set it up digitally. The Department of Defense want to get access to the product, and they were having conversations with us, with the FDA around the approach we might take to an emergency use authorization as a first step before BLA. So more to come on that, Anthony, as we get more information on it. But I think it's positive at least I see it as positive that the Department of Defense are pushing for an emergency use authorization to get the product to the troops.
Anthony Petrone:
Okay. Thanks again.
Liam Kelly:
Thank you.
Operator:
Your next question comes from Chris Cooley of Stephens. Your line is now open, sir.
Chris Cooley:
I'll just ask my two in succession. When we look at the UroLift offering here in the second half of the year, you obviously have the ATC latter at the very end of this year, the national DTC campaign, scaling. I know you don't generally comment on product-specific level detail, but is it out of the realm of the possibility to think that UroLift could still see a flat to modest growth trajectory in 2020 before building momentum into 2021? And then on a bigger picture of scale, a little bit interested, and you talked about a reduction in force in a couple of select markets. But as we've looked at these last really 3, four months with COVID-19, I'm curious what more durable learnings you've taken away in terms of just how you operate that you think will make Teleflex a more efficient business going forward? Not so much just from a headcount reduction, but maybe how you go to market, maybe how you source on the raw materials side. But just kind of curious about what things are being put in place now that we'll see as a benefit potentially in 2021 and beyond as things hopefully start to normalize again?
Liam Kelly:
Thank you, Chris. So first of all, on the UroLift, I don't want to go into too much detail on what we expect for the full year. Obviously, we pulled guidance and there's so much variability with COVID, it's hard to see that. But I mean, the great thing is that every journey begins with the first step. And our first step is to get this to a positive growth in July. So it has turned very modestly green in the first few weeks of July, which we're encouraged by. And that gives us encouragement that we should have, for sure, positive growth as we go into Q4 and begin to then bounce into 2021 on a more normalized level of good, solid growth. Because every dollar that we grow on UroLift, as we all know, is a good dollar for Teleflex because of the margin profile on it. The other thing I would say is that we're also having the UL2 submitted for 510(k) at the end of June, that should help us then with our margin profile as we get into 2021 as we roll out the UL2 to the urologists. With regard to the reduction in force, the reduction in force from a sales and marketing perspective in Europe is really focused on growth. What we're doing is we're reapplying resources into our faster-growing assets, like the UroLift, like the Interventional Access portfolio, like our Vascular portfolio. And I think that is a work that we're doing to drive growth within the business and also rightsize that organization for that growth. Our long-term learnings, I think there are a few. I think we've seen an organization that has worked incredibly well and incredibly adaptable, incredibly efficient without being in an office environment. We have engaged with customers at a very high level. We ran a full BPH Summit in the UroLift product virtually. We attended virtually the AUA. We did virtual trainings on MANTA on the Interventional business. And we have on some of our go directs, that we worked through, we have done some virtual due diligence on some of those smaller as we've gone through the COVID crisis. So I think a reduction in our overall T&E on a longer-term basis and on our cost of office space is something that will happen. And also, less wins, we can make our sales organization a lot more efficient by eliminating windscreen time and using technologies to get them in front of a customer virtually. So a lot of learnings and a lot of changes that, I think, will be positive for us in the longer-term to drive keep driving our top line growth as efficiently as possible.
Chris Cooley:
Thank you.
Operator:
Next question comes from Mr. Matthew O'Brien of Piper Sandler. Your line is now open, sir.
Matthew O'Brien:
Liam, just to continue down the UroLift path and sorry to continue to go down this way. But you said going into the year, you thought you would grow about 25% in that franchise. The first couple of quarters on an adjusted basis would have been well ahead of those levels. What is what are you seeing in the marketplace that's getting you above what you kind of thought going into the year, again on an adjusted basis? Are you seeing docs that are now attracting a lot more patients to their facilities as a result of having UroLift available? Is there that dynamic going on? Anything along those lines to really point to? And then as you're rolling out UroLift two probably late this year into next year, how do you do that successfully without disrupting the business with the DTC tailwind that you likely will have? And then I have a follow-up.
Liam Kelly:
Absolutely, Matt. I'll take the latter part of it first, if you don't mind, the UL2 rollout. The reason that we believe that it's not going to cause any disruption is that it is works very similar to the UL1, looks like the UL1 as a cartridge system, but has all the advantages of the UL1 with great patient outcomes and is easier to use. It only takes five cases for us to train a urologist to move them from a UL1 to the UL2. That is about less days work in a urology practice to convert them. So I don't believe it's going to be disruptive for all of those reasons. And there's an advantage to Teleflex to the adoption of the UL2 and there's an advantage to the urologist as urologist will get the great patient outcomes. They've always got no sexual dysfunction, not great IPSS score and so on and so forth. But it will also reduce their carbon footprint and their clinical waste. So if they're in a urology office practice, it will make their practice that little bit more profitable for them. With regard to the actual growth rate, look, we're very encouraged by the growth rate. I think that traditionally, we've been relatively conservative right out of the gate with our projections for the UroLift product. And I think most people thought that 25% was a little bit conservative also. But notwithstanding that, I think we the reason we're normally conservative is because we're moving from the early adopter to the fast follower. And what we've seen is the fast followers are now adopting the technology at a quicker rate than we had originally considered. And as long as we can continue that great work and momentum, I think that will be positive. The and the accelerators to that, that have helped us get it there are the investments we've made. The investments we've made in the sales force in Q4 rather than wait into Q1, and the investments that we continue to make behind DTC and product innovation and the investments we continue to make behind clinical papers in order to bring the technology to a broader base of urologists than we have today. But we still only suppress the fact that it's such a large market. We've done as I said, to date, we've done 200,000 cases out of 100 million men.
Matthew O'Brien:
Right. Now that's very helpful commentary, Liam. I just wanted to pivot over to Vascular Access for a bit here. That's an area that has benefited from COVID, but you have a lot of really unique differentiated products within that franchise. So do you think COVID is something that actually has eliminated the uniqueness of all those products and could actually supercharge that franchise to some extent over the next couple of years? Or do you think you may, as things kind of level off or we come out of this thing, you may face a little bit of a revenue headwind because people you're not seeing as many COVID patients, etc?
Liam Kelly:
Yes. So the main benefactor of in the Vascular business unit of the COVID pandemic was our CVC franchise. Matt, we're market leader. I think we have close to 90% market share in North America on central venous catheters because of our coating technology, because of its impact on infections within patients and hospitals. The area that we traditionally have been growing is in our PICC portfolio because of our coating technology. Now there's an interesting dynamic going on in the midst of COVID. The dynamic is we have increased demand for CVCs because there are more patients in intensive care units. The other dynamic is we're not able to convert as many big customers that we had traditionally because we can't get access to the hospital in the midst of COVID. So as you come out and things start to normalize, you'll see two things. You'll see the CVC growth get back to more normalized levels in that, call it, 4-ish percent, but you'll also see PICC growth start to pick up. All in all, Matt, it should be a modest headwind for us rather than a tailwind because our CVC franchise is just so much bigger than our PICC franchise, but a modest headwind as it normalizes. I also believe what you will see in the latter half of the year, though, is you'll see hospitals making sure that they have enough CVC kits in case there's a second wave to help them manage through it. So we might not see the headwind until 2021. And by that stage, the other areas of the businesses that were negatively impacted will more than offset it with the weaker comps, in particular in Q1 and Q2. So that's how I see it playing out over the next 18 months, call it.
Operator:
Next question comes from Mr. Mike Matson of Needham & Company. Your line is now open, sir.
Mike Matson:
I guess I just have 2. So first, with the OEM business, it did look like you had a pretty big negative impact from COVID. But I'm just wondering if there's any kind of potential for some lag there as your device customers sort of maybe go through some destocking, if their inventory levels ended up higher at the end of the second quarter? And then, I guess, another sort of destocking-related question. I know that for your business overall, distributors are a much smaller part of your revenue now. But do you have any feel for the amount of inventory at those distributors now?
Liam Kelly:
Yes, Mike, thank you very much for the questions. I'll start with OEM and the lag question. So what we saw with our OEM business as we went through the quarter, we saw positive growth in April and May for the OEM business. And then we saw a negative 13% in June to have a total quarter of a negative of about 0.7%, and that was definitely the lag that hit us in June. Now as we've gone through July, I would say the negative lag of 13% has improved. Again, I don't want to mislead anybody that it's in the green territory in the same way as UroLift is, but the negative lag has been less. So we always expected there will be a delay with OEM because as you point out, that's the nature of the business. So I think that's what's happened with the OEM business. As we look at our distributors, and again, I'll start with the tracings for the distributors. And I always look at the tracings, to understand what's happening with our business overall. And the tracings for our end customers through the first half of the year almost exactly mirrors the results that we're seeing in our published results. So that means that it's aligned. And what we saw in the quarter was a very, very modest increase in inventory, but very modest, Mike. You could almost see it as neutral sales-in versus sales-out in the quarter.
Mike Matson:
Okay that makes sense.
Liam Kelly:
Thank you.
Operator:
Your next question comes from Ms. Kristen Stewart of Barclays. Your line is now open, sir.
Kristen Stewart:
Just want to say thanks for all the level of detail that you provided on the call. Really appreciate it. I just wanted to go back to this NeoTract disclosure in the 10-Q. I appreciate that you're being proactive and talking about it today ahead of the filing. Just a couple of questions here. I guess, what gives you the level of comfort that this won't have any I know this question came up before, but I guess I'm just struggling with the level of confidence that it won't really have a commercial impact. And I'm just kind of curious as to why it's just a single customer. I've just never really seen this before. And is there any way to kind of put into context the size of the single customer in terms of a larger customer? And what's really the risk as well that this spills into additional customer arrangements? Because it's always kind of been one of the key, I guess not the, I guess, one aspect of the benefits of UroLift has always been one of the reimbursement benefits of it. So I'm just concerned that maybe there's something with the rebates or the reimbursement aspects around it. Obviously, the clinical benefits of the product stand for itself and has always been out there, and you've had a lot of clinical data, but I'm just kind of concerned that as your competitors may get out there and use this as a marketing talking point, there might be some impacts from a commercial standpoint. So I guess, where are you getting kind of the level of confidence that it won't have a more meaningful impact from a commercial standpoint?
Liam Kelly:
So first of all, and again, as you can appreciate, Kristen, it's very early days, and we're fairly limited in what we can say and disclose. But it's pretty unusual, at least in my experience for companies to use this type of a the scenario, the marketing tool against another company. And I think that would not be seen as positive by any of the regulators and authorities. The other thing I would say is that the Attorney General's Office does not have responsibility for reimbursement. That's a separate organization that manages reimbursement. And reimbursement is really based on the time that's spent on the procedure and the overall cost of the procedure and the benefit that the procedure gives to the patient. My comments on commercial impact were really on the basis that this will take a longer period of time for the information flow between us and the Attorney General's Office to truly have a better understanding if there is any commercial impact. But I would be very thoughtful not to link the disclosure to what happens on a reimbursement level for a product like this, they are two completely separate topics. So I think that will be a tough line to walk, Kristen.
Kristen Stewart:
Okay. Anything just in terms of the sizing of this customer? Is it a very large customer? Is there a risk that something could fall in terms of other customers within the area? It's just kind of odd that it's just one single customer that would be focused on.
Liam Kelly:
I just think this is a very specific focus by that office, but I don't want to go into details on one particular customer or another, to be honest, Kristen.
Kristen Stewart:
Okay. That’s fair enough. Okay. Thank you.
Liam Kelly:
Thank you very much. Appreciate the questions.
Operator:
Thank you, very much. At this time, I would like to turn back the line to Mr. Jake Elguicze. Sir, your line is now open.
Jacob Elguicze:
Yes. Thank you, operator, and thanks to everyone that joined us on the call today. This concludes the Teleflex Incorporated second quarter 2020 earnings conference call. Have a nice day.
Operator:
Ladies and gentlemen, thank you for standing by, and welcome to the First Quarter 2020 Teleflex Inc. Earnings Conference Call. At this time all participants are in a listen only mode. After the speakers presentation there will be a question-and-answer session. [Operator instructions] Please be advised that today’s conference is being recorded. [Operator instructions] I would now like to hand the conference to your speaker today, Jacob Elguicze, Treasurer and Vice President of Investor Relations. Please go ahead, sir.
Jacob Elguicze:
Good morning, everyone, and welcome to the Teleflex Inc. First Quarter 2020 Earnings Conference Call. The press release and slides to accompany this call are available on our website at www.teleflex.com. And as a reminder, this call will be available on our website, and a replay will be available by dialing 8-558-592-056 or for international calls, 404-537-3406, pass code 7545905. Participating on today’s call are Liam Kelly, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks, and then we’ll open up the call to Q&A. Before we begin, I’d like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include but are not limited to, factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. With that, I’d like to now turn the call over to Liam.
Liam Kelly:
Thank you, Jake, and good morning, everyone. It’s a pleasure to speak with you today. Before I get into the details of our quarterly performance, I’d like to offer my condolences to anyone who has been impacted by the coronavirus. As well as my sincere thanks to all the health care workers, including Teleflex workers who have returned to clinical practice, who put themselves at risks to battle COVID-19 every day. I’d also like to take a moment to recognize the Teleflex employees around the world. These last few months have been far from normal, and our employees continue to inspire me as they have stepped up in extraordinary ways to ensure that we are able to provide our products to the hospitals, clinicians and patients who need them most. So a big thank you to all Teleflex employees. Now on to our quarter one results. So, the first quarter of 2020 was a solid start to the year for Teleflex. Particularly when you take into consideration the global escalation of the COVID-19 pandemic. During quarter one, we generated constant currency revenue growth of 4%. While on a selling day neutral basis, our constant currency revenue growth was approximately 5.5%. Quarter 1 revenue growth was driven by the performance of our Americas, EMEA and OEM segments. But our Asia segment experienced a decline due to COVID-19. From a margin perspective, we generated adjusted gross and operating margins of 57.3% and 25.6%, respectively. This translated into year-over-year growth of 60 basis points at the gross margin line and 190 basis points at the operating margin line. While from an adjusted earnings per share standpoint, we achieved a robust year-over-year increase of 21.4% as earnings per share totaled $2.72 during the quarter. I’m extremely pleased in our ability to drive significant leverage throughout the income statement while navigating through a very difficult operating environment. It is a testament to the strength of the diversified global portfolio we have built over the past few years. Next, I thought it would be helpful to provide some context regarding how we saw COVID-19 impact our first quarter results. As a reminder, our previously provided full year 2020 financial guidance assumed that we would be negatively impacted from COVID-19 by between $5 million and $10 million in the revenue and between $0.05 and $0.10 of adjusted earnings per share. This was assumed to all be related to our business within China. And it was expected to only be a quarter 1 event. It is important to keep in mind that when we provided our guidance on February 20, COVID-19 was largely only impacting China. As we progress through the first quarter, the months of January and February as well as the first 2 weeks of March, were largely in line with our initial expectations, and we did not see much of a negative impact outside of China. However, as the virus began to spread further globally, coupled with the announcement from the American College of Surgeons and the surgeon general, requiring hospitals to postpone and any procedures that are considered to be nonemergent or elective in nature, we began to see more of a pronounced negative impact during the last few weeks of the quarter. And while we estimate that only 1/3 of our product portfolio is correlated to nonemergent or elective procedures, we still felt an impact to our business. During the last few weeks of March, this additional headwind largely occurred within the Americas. [Indiscernible] And primarily within our Interventional Urology, Interventional Access and Surgical product lines. We did see some offset within the Americas from increased sales of certain respiratory products. However, that was not enough to offset the lost revenue and margins from the canceled procedures. Turning to EMEA. We saw a significant increased demand for certain Vascular Access, respiratory and Anesthesia products, and we estimate that our results within this part of the world benefited due to increased demand for our products used in the treatment of patients with COVID-19. While within Asia, the impact from COVID-19 was in line with our previous assumptions. In total, during the quarter, we experienced a revenue headwind that was slightly worse than our initial guidance contemplated while at the adjusted earnings line, the headwind was in line with the high end of our original estimates. This is despite our guidance anticipating an impact in China only, as the virus has expanded beyond China to the rest of the world. Next, I’d like to provide you with our thoughts as we look forward to the remainder of the year. First and foremost, I want to share with you the guiding principles we established as a framework for decision-making through the crisis
Thomas Powell:
Thanks, Liam, and good morning, everyone. Given the previous discussion of the company’s revenue performance, I’ll begin at the gross profit line. For the quarter, adjusted gross profit was $361.1 million versus $347.8 million in the prior year quarter or an increase of approximately 4%. Adjusted gross margin totaled 57.3% during the quarter, which is an increase of 60 basis points versus the prior year period. The improvement in gross margin was largely due to favorable product mix, benefits from cost improvement initiatives and the impact of favorable fluctuations in foreign currency exchange rates. The mix benefit realized during the quarter was lessened by the impact of COVID-19 as the adverse revenue impact tended to skew toward higher gross margin products, including UroLift, Surgical and Interventional Access. In light of the reduced revenue outlook resulting from COVID-19, we have proactively looked at expenses in order to identify prudent opportunities to offset the COVID-19 related earnings impact while at the same time, preserving Teleflex’s ability to rapidly rebound once elective procedures recover. The combination of gross margin expansion and OpEx expense measures combined for a 190 basis point increase to adjusted operating margin, which came in at 25.6% for the first quarter. Included in the first quarter operating margin results was a foreign exchange headwind of approximately 50 basis points. Adjusted operating profit was $161.6 million as compared to $145.6 million in the prior year or an increase of approximately 11%. Continuing down the income statement. Net interest expense for the quarter totaled $14.9 million, which is a decrease of approximately 34% versus the prior year quarter. The decrease in interest expense primarily reflects reduced interest rates associated with our variable interest rate debt instruments as well as a cross-currency swap agreement that we executed in the first quarter of 2019. Moving to taxes. For the first quarter of 2020, our adjusted tax rate was 12.5% as compared to 14.8% in the prior year period. The year-over-year decline in our adjusted tax rate is primarily due to a more favorable mix of taxable income in the first quarter of 2020 versus the prior year period, offset in part by a lesser benefit from stock-based compensation. On the bottom line, first quarter adjusted earnings per share increased 21.4% to $2.72. Included in this result is an adverse foreign exchange impact of $0.10. Overall, we are very pleased with the strong bottom line growth despite the headwinds from COVID and FX. Turning now to select balance sheet and cash flow highlights. For the first quarter of 2020, cash used from operations totaled $11.5 million as compared to an inflow of $60.2 million in the prior year period. The decrease is explained by a $53.9 million increase in contingent consideration payments, largely related to milestone payments stemming from the acquisition of NeoTract. Additionally, a $10 million pension contribution was made in the first quarter of 2020. Overall, the balance sheet remains in good shape. At the end of the first quarter, our cash balance was $406 million and our U.S. cash balance was $182 million. Net leverage at quarter end was approximately 2.6x, providing comfortable headroom when compared to our covenant, which requires that we stay below 4.5x. Lastly, we have no near-term debt maturities of a material size. Then to pressure test our liquidity outlook in light of COVID-19, we prepared several recovery scenarios with varying recovery time lines. Under each scenario, Teleflex maintains sufficient liquidity to execute our plans and maintain comfortable covenant headroom with additional borrowing capacity remaining in place and available from our already existing credit facility. And that concludes my prepared remarks. I’d like to now turn the call back to Liam for closing commentary. Liam?
Liam Kelly:
Thank you, Tom. In closing, we delivered solid first quarter results, bearing witness to the benefit of our global diversified portfolio. And while it is difficult to predict whether the path to recovery will be V-shaped, U-shaped or even W-shaped. We, as an organization, will continue to monitor closely the reopening plan state-by-state and country-by-country to ensure we take full advantage as states and countries reopen. We have introduced digital tools to our business units, where we believe it can be an effective in training clinicians on the safe and efficacious use of our products. We will manage the business prudently while staying focused on capitalizing on the long-term potential of our global product portfolio. I would like to finish by again thanking all of our employees who continue to manufacture, distribute and support products that are acquired in the fight of COVID-19. And I’ve been humbled by the response of Teleflex employees as we continue to deliver on our commitments to our customers, their patients and our investors. That concludes my prepared remarks. Now I’d like to turn the call back to the operator for Q&A.
Operator:
[Operator instructions] And our first question will come from the line of David Lewis from Morgan Stanley.
David Lewis:
Just 2 questions for me. I’m going to start with UroLift and then move on to one other segment. So, Liam, you discussed UroLift multiple times and your confidence sort of to the recovery. I just wonder if you could talk about the business trends here. How much was the business down at trough? And have you seen a bounce off April lows? And you talked a lot about ASC access as an advantage but how are you feeling about the 70-year old average patient age and how the referral trend or the patient will react? And then I had a quick follow-up on respiratory.
Liam Kelly:
Okay. Thanks, David. So, I’ll talk about the trends that we saw as we went through January and February in regards to the UroLift and then what we saw in March. And I think that will give a good indication to the investment community as to what occurred cures procedures were canceled. So, if we look at January and February, we were actually growing the UroLift business at just over 38%. And in March, the business declined by 3.3%. In the last 2 weeks of March, if you compare that to the first 11 weeks, we actually saw a 64-ish percent decline in the business in those last 2 weeks as procedures got canceled. Now if I look at the other part of your question regarding why we think it’s going to recover and access and the age of the patient. First of all, the average age of a UroLift patient is not 70. The average age of a UroLift patient is just over 60. So, we don’t have, for sure, men in that 70-plus or in a higher risk category. And I think it’s all about customer confidence, consumer confidence as they go back into these centers. But the reason that I’m confident that UroLift is going to recover quickly is on a number of points. First, when I’m speaking to urologists, we know that there is capacity and a desire to do UroLift procedures. We’ve actually conducted a survey with over 170 urologists, and 60% of the urologists were contemplating, scheduling adjustments post-COVID. And investors that are familiar with the UroLift will be aware that, that 60% of UroLift procedures are performed outside of the hospital, and we believe consumer confidence will return first in the ASC and the office environment. And UroLift will obviously benefit from the states that move to Phase I on with CMS and the American College of Surgeons and other leading groups in agreements that outpatient procedures will recover first. So that also leads to our confidence. And the procedure can be performed within 1 hour in a doc’s office or in an ASC or even in a hospital and is the only procedure that will allow to prevent sexual dysfunction. And thirdly, there’s a strong financial incent for urologists and our sales force to ramp back up as quickly as possible. And if you look at the cadence of states, we spent some time looking at that. The 18 states and territories that are about to open or will open in the near future, account for about 32%. There are 4 other states coming quickly behind those, and they account for another 27%. So roughly 60% of the states, that where our business is done are going to open up in the near future. And last thing I’ll say is in that survey that we did, David, it highlighted that BPH is in the top 4 disease states that are being prioritized by urologists as they get back to work behind things like prostate cancer and kidney stones, which are obviously emergent and need a boost are emergent and will develop pain for the patient. And I think lastly, the last comment I’ll make, David, is our DTC campaign, when we bring that online could be a catalyst also to encourage men to go to these practices. Sorry for the long answer, but I think there’s a lot in that question.
David Lewis:
I just -- story on the detail, Liam, exactly what I think investors were looking for. And just I’ll do a quick one here to wrap up. 2 businesses that were more durable here in the first quarter were respiratory and OEM. I’m just kind of curious how you see those businesses tracking here on a go-forward basis.
Liam Kelly:
So you’re correct on our respiratory business. And again, I’ll give you the similar commentary on respiratory that I gave you on Interventional Urology. Respiratory in January and February had a small decline, about 2.2%. And you’d expect that, distributors tend to destock in the first couple of months of the year. In March, our respiratory business grew by 44%, culminating in over a 13% growth in the quarter, and that’s clearly because as COVID-19 had an impact, we saw first in EMEA increased orders for respiratory products, followed quickly by our American business. And then in relation to our OEM business, again, it’s a great business. It grew by 17.5%. No real day adjustment here, about half of the growth came from the acquisition and the other half approximately came from the core business. So OEM business has continued to perform excellently as it has done over the past number of years. As we move forward, we’ll keep a close eye on the COVID impact on the OEM. As I said in my prepared remarks, it’s difficult to ascertain that as we move forward because we make products for other companies, and we don’t know yet what the impact is to those companies. So thanks for the questions, David.
Operator:
And our next question comes from the line of Larry Keusch from Raymond James.
Larry Keusch:
I’m glad to hear everyone is safe. Just wanted to, Liam, maybe start with, as you think about the month of April, you provided some color on some of the parts of the business. But what can you tell us about how April is tracking? And specifically, how are we thinking about the various regions, Americas, EMEA and then Asia Pacific?
Liam Kelly:
Well, Larry, I’m going to try and stay away from discussing intra-quarter results given that we have withdrawn our guidance. I’ll tell you what I, what happened as we entered into the COVID-19 crisis. And I’ll tell you what happened in EMEA and then what happened in March in the Americas. So, it’s -- the COVID pandemic spread from Asia to EMEA first. As hospitals realize, a lot more patients were turning up with respiratory conditions, they, we got an overwhelming number of orders for our respiratory products. And following on from that as patients then migrated through the hospital into the intensive care unit, we got increased orders in our Anesthesia portfolio for airway management products, circuits, ET tubes, those types of the products. And then about a week or 10 days later, as these patients needed vascular access, we saw a ramp-up in our Vascular portfolio within EMEA. The Americas tracked shortly after that. And we saw the almost exact same trend where you saw an increase in respiratory products, an increase in airway management products, and I would expect it to be followed by an increase in vascular products based on the same trend that we saw within in EMEA.
Larry Keusch:
Okay. And then maybe just to finish that thought off, sort of where do you think China is now in terms of, are you seeing recovery there? And then the other question is, I know that you referenced 60% of UroLift procedures being done outside of the acute care setting, do you think there are ways that you can help move some of that outside of the hospital at this point so that perhaps some of that actually can come back faster if you can get it moved into doctor’s office or ambulatory surgical setting?
Liam Kelly:
Yes. I’ll deal with the last part first. I mean, the one thing that I’m encouraged by is that we know that there is capacity in the ASC and in particular, within the office setting. We know also that it is a very effective procedure with great outcomes, and we know that it’s a profitable procedure in both of those settings. And given all of that, fact-based, it is very dependent thereafter on practice by practice. If a urologist has an office setting and does some work in a hospital, then, of course, they have that flexibility to move it to an ASC or an office environment. And if they don’t then they have, then it’s less likely to move. But there is capacity, Larry, and any time there’s capacity, our expectation is that there is flexibility to move from the hospital to the ASC or the office. Regarding the first part of your question on what we saw in China. So what we saw in February and March, was procedures beginning to come back, in particular, in March as they ramped up and it’s very dependent, I guess, city by city. In April, they actually allowed the residents of Hubei to move really throughout the country. As they stopped the lockdown in that part of the world. But what we see in Shanghai, in particular, is as we got towards the end of March, we started to see procedures getting to some sense of normalcy towards the end of March, and we expect Beijing to follow suit very, very quickly. And a lot of our business is done down in the Eastern Seaboard, Larry, so we expect to get back to some level of normalcy as we go through this quarter or quarter 2.
Operator:
And our next question will come from the line of Jamie Morgan from SVB Leerink.
Rich Newitter:
This is Rich Newitter from SVB Leerink. I wanted to just ask, first, Liam, on the long-range plan targets, particularly the margin trajectory, I appreciate you withdrew 2020 guidance but much of your spend is under your control. And maybe if you were to just take your base case, you said you were planning on multiple cases in the wake of COVID but if you took your base case, are the long-range margin targets still achievable, maybe not 2021, but say, within the 2-year timeframe, can you give any color there?
Liam Kelly:
Yes. Rich, thanks for the question. So, let me begin by saying, Rich, that we continue to believe that our product portfolio is capable of reaching the 67%, 60%, 61% and 30% plus levels that we put out there a few years ago. That’s it, given the fact that we just withdrew our full year 2020 guidance because of this uncertainty surrounding COVID, it will be very difficult for me to sit here right now and tell you that we can still reach those goals by 2021. And we need to see countries reopen. We definitely need to see the U.S. reopen and procedures return. And once we see that occur, we will have a better idea as to the timeframe where we can achieve those goals. But as I sit here now, I’m still very confident in achieving those longer-term goals. The only uncertainty that’s in my mind is the timing. And I’ll want to see the recovery before I give more detail on that.
Rich Newitter:
And maybe just one more. M&A, obviously, has been central to the strategy at Teleflex for a number of years now. I’m just curious, you went through your liquidity position, but how was that all BD activity changing in the wake of COVID?
Liam Kelly:
Yes. Well, obviously, I still think that our preferred use of cash remains to conduct M&A although having said that, given the high level of uncertainty regarding how long the COVID-19 situation might last, we think it’s reasonable to assume that M&A will slow down in this environment. I think you hit a very important point there, Rich, that our leverage ratio is about 2.6x right now. So we’re in a pretty healthy spot. So, I think in the shorter term, we’ll be relatively cautious and prudent. But I think over the medium term, M&A will for sure continue to play an important role in our transformation from a medium growth company with margin expansion to a high-growth company with margin expansion. And the new reality will be that sellers will now be looking at the valuations that were much higher a couple of months ago. And this might actually present an opportunity for a company like Teleflex with our current liquidity situation. We are in a little bit of uncharted water here with COVID-19. And as a result, I would like the investment community to rest easy, we will continue to be as disciplined as we have ever been as we identify the appropriate targets and I don’t think that now would be the right time to do a billion-dollar transaction in the current environment. So, we will continue to be prudent and we’ll prioritize the strength of our balance sheet amid this evolving situation.
Operator:
And our next question will come from the line of Shagun Singh from Wells Fargo.
Shagun Chadha:
Liam, I was just curious if you think we could see a period of above-average age growth in Q3 as physicians begin working through the backlog and as patients schedule procedures, ahead of the fall, which would be prior to the start of the flu season or for fear of a second wave in the fall? And then I have a follow-up.
Liam Kelly:
So I think, Shagun that as I look at it right now, as I said earlier, we see states begin to reopen. I think we’re going to learn a lot in the next month, and it is very dependent on whether we see a spike in COVID-19 or if we see those curves continue to flatten. In my mind, it’s all about consumer confidence. What I’m actually looking for is when people start to go back to their dentist, and I know we’re not in the dentist business but if people start and if I see my friends going to the dentist, that will mean that we’re very close to people going back to an office and an ASC to have a UroLift procedure done. And if that happens in the second quarter, and it looks like it’s going to begin in the second quarter, I’ll go back to what I said earlier. There’s capacity to do the UroLift procedures, which is the one that was mostly impacted by the postponement of some of these procedures. So therefore, I would anticipate that in Q3 and in Q4, that those procedures, a lot of them would come back. I did speak to a urologist recently, and that individual reiterated what I expected that he would that he has not canceled any UroLift procedures. He has simply postponed them to a later date. So those patients are still currently scheduled in his practice to have that procedure done.
Shagun Chadha:
That’s really helpful. And just a question on MANTA. You initiated a full launch on January 1. Can you give us any color on the kind of adoption you saw through mid-March? Any color you can give in terms of procedures? And then what were sales in Q1?
Liam Kelly:
Yes, absolutely. So as those of you that are familiar with our story will know that we had converted 4% of the market last year. And our goal this year was to convert 8% of the global market. I can tell you that MANTA was performing really, really well prior to the impact of COVID. As we went through January and February, we saw significant growth. And if I just took January and February, and if I took 2 months of the global market, we actually had approximately 6% of the global market converted on a pro forma basis, just under revenue we generated in January and in February. Once we got into the last 2 weeks of March, and I’ll give you the same data that I gave for UroLift, we saw a 35% decline in the last 2 weeks of March compared to the first 11 weeks. Just as procedures got pushed out, but the adoption has gone really well. The price point is right in line with what we expected. And again, as these procedures come back, we would believe that this product will come back. And this is one of the products that we are using in some of our digital tools, Telehealth tools that I mentioned in my prepared remarks, to train physicians, even if our salespeople cannot go into the office. And lastly, we have in place the 20-plus associate sales reps that we have planned to have to support this product, and they are active and will be ready once procedures start to come back into the hospitals.
Operator:
And our next question comes from the line of Raj Denhoy from Jefferies.
Anthony Petrone:
It’s Anthony for Raj here. I’m glad to hear everyone’s healthy and good luck to you all through this, the current cycle we’re in. A couple on UroLift. Just as it relates to the current margin profile of that franchise, just considering that you have UL2 and UL out there. So I’m just wondering, what is the status of the margin profile of UroLift at the moment? And then maybe an update on the OUS expansion plans. I think Japan was expected at least a soft rollout first half. And just wondering what COVID does to the OUS expansion plans for UroLift? And then I’ll have one follow-up.
Liam Kelly:
Okay. So the main margin profile of UroLift wouldn’t have changed, Anthony. It’s still in the mid-70s. Our goal is still to roll out the UL2 to get that into the high 70s. And just given COVID-19 and the fact that the FDA have been focused on addressing COVID-19, that will have a slight delay to our 510(k) submission so that will probably be in the June, July timeframe, and then we’ll have a 60-day, 90-day review before we get the product to market. I tell you that because that will have an impact on the Japan rollout. We expect it to be generating revenue in Japan early in 2021. We will probably now be generating revenue in Q1 or, or pardon me from Q1 to Q2, unlikely to go to Q3, but it could go to Q3. It really does depend on the reviewed time. But we will still be generating revenue in 2021. And I would just like to remind everybody that in our LRP, there was no revenue for Japan contemplated in our LRP. So we still envision that we will be generating, most likely in the Q2-ish timeframe revenue in Japan following the reimbursement approval.
Anthony Petrone:
And then the follow-up would be, outside of coronavirus, as you do your internal modeling, just any thoughts on the economy? You mentioned that 25% are elective procedures, so it seems that the Teleflex portfolio for a recession is relatively durable. But any views just on economy, unemployment rates, how that plays in? And how you guys are thinking about that internally?
Liam Kelly:
Yes. So no industry is immune to the impact of a recession. But I’m sure as all, every analyst is aware, the industry that is probably more sheltered is medical devices. People, whether you’re in a growing economy or a lagging economy or a recession economy, people still get it, and there is a requirement for our products. Part of our thinking behind the building of our portfolio and really focusing 2/3 of it on nonemergent critical procedures is exactly that to ensure the procedures could not get postponed, it’s standing as in good stead in the COVID-19 crisis that we’re seeing right now because such a small part of our overall portfolio is impacted by postponement of procedures. That same fact pattern would stand to Teleflex also in a recession, where procedures that would not be in a position to get postponed. And even then our procedure that is probably the most selective to UroLift, the health care economics on that are so strong that it is actually even in a recession, it is saving the health systems money as more patients opt for a UroLift procedure.
Operator:
And our next question will come from the line of Matt Taylor from UBS.
Matt Taylor:
The first one was, I appreciate that cadence that you talked about with the ordering patterns around respiratory, airway management and vascular access. I guess I was wondering if you knew from the trends, you mentioned 44% growth, I think, in March. From what you’ve seen since then, do you think there was a lot of stocking there or do you think that is being actually used because of large number of COVID patients in those centers?
Liam Kelly:
That’s an excellent question, Matt. What we saw at the end of the quarter, we -- and as I said in my prepared remarks, we carried a significant backlog into the quarter. So our normal backlog of orders would, in these product categories, and for our overall business would be about 1-day sales. As we went into April, that was more than -- that was almost triple our normal backlog that we would tend to carry. We are -- we ramped up manufacturing of these respiratory products, some of them by 200% in order to try and address the pandemic. The products will be getting used by the hospitals that are treating COVID patients. Every patient that goes on a ventilator will require a filter -- a bacterial filter. It protects the patients and the people around them, but it also protects the ventilator so you don’t get cross infections. Every patient also will have a HEPA filter, it’s a heat moisture exchange filter, in order to do the work of the nose. We believe that these products are being consumed. No doubt, I think post the pandemic, I think that hospitals and distributors will actually hold more inventory of these products. I think people, as I said also in my prepared remarks, is it a V-recovery? Is it U-recovery? Or is it a [indiscernible] so you go down to larger stockpiles, and we are engaging with government agencies right now because we are prepared to stay building these products, but we want to understand what government agencies want to do with regard to their stockpile actions for key respiratory, Anesthesia and Vascular products.
Matt Taylor:
And then you provided a lot of nice totals around UroLift. I had one more follow-up on that, actually. So, you mentioned talking to some customers who hadn’t canceled cases. I was wondering if you knew, just typically, if you could characterize for us about how far out those cases are typically booked. And then to get patients back in the funnel, is there a lot of testing or evaluation that has to be done? Or is it pretty quick and easy?
Liam Kelly:
So, I’ll deal with the last part of it first. So, if you’re suffering with BPH, your BPH condition is not one that’s going to get better, Matt. So, the urologist would normally use IPSS scores, and it’s a very simple methodology to get a patient’s IPSS scores and it takes about 5 minutes. And the patient, in many instances, can do it online for the urologist. So, there’s no major testing or anything that has to be done in order to reposition the patient. We know that from our digital media and regional DTC campaigns that a patient needs to be scheduled within 4 weeks or so in order for a high acceptance rate of doing the procedure. So that’s what we know from the DTC. And I think it’s around that 4-ish weeks, Matt. And as I said, there is capacity, in particular, within the office and the ASC to schedule these patients to bring in newer patients. Obviously, the offices will have to implement some procedures around social distancing, around face masks as they see appropriate. In order to get it up and running. But I think it should be, at least my perspective is that now that urology practices know which states are opening. We’re actually, again, using some of our digital tools to train urologists to revisit some of the training to make sure that they are ready and prepared to re-engage with their patients. And obviously, as I said in my prepared remarks, we have our DTC campaigns also ready to reengage with those men in order to heighten their awareness of BPH.
Operator:
And our next question will come from the line of Matt O’brien from Piper Sandler.
Andrew Stafford:
This is Drew on for Matt. I wanted to follow-up a little bit on MANTA here. I guess as things begin to loosen up a little bit in the next couple of months from a hospital perspective, just wondering if you’ve kind of gotten a sense on how they will prioritize some things over others? And I guess, specifically, I’m trying to get at beyond what you’ve already said, is there any risk that training on new products such as MANTA could be put off for the time being as hospitals work through backlogs and prioritize whole time?
Liam Kelly:
Yes, Drew, thanks for the question. Let me give you a little bit of added color on what we saw in the key North American market from a revenue perspective in the first 2 months of our full launch. So we had done a limited launch. And as customers are ramping into Q1, 80% of our revenue came from existing customers. So it’s all about driving utilization. Now those customers have already been trained, those customers are already up and running. A large majority in the high 80s of our revenue came from TAVR procedures. So we believe that TAVR procedures should come back relatively early on in the cycle, which should help us. And as I also said in my prepared remarks, Drew, we are using digital tools in the Interventional Access business unit to train our customers on MANTA, and we also have uploaded some training videos to make that available to them. And as hospitals allow salespeople back in, they are allowing them in for critical new product trading procedures. And we, as an organization, have organized protective clothing materials for our sales organization to allow them to re-enter the hospital system.
Andrew Stafford:
Okay. That’s good to hear. And then I guess my quick follow-up here, we’ve been hearing about a lot of clinical trial delays across Medtech over the last couple of weeks. Obviously, a chunk of your growth has been driven by new products. It sounds like you’re going to continue all your R&D efforts to all this. But anything meaningful from a clinical trial perspective that may be put on hold temporarily?
Liam Kelly:
Yes. Thank you. We had one MANTA trial that we were in sponsoring that, it was very near the end of its completion. So I don’t think that’s going to have a big impact. We will assess new products as we come out the other side of COVID. I think, Drew, it’s a little bit too early to give any indication as to where we’re at with new products. But we didn’t have, we had some clinical trials going on in the Interventional Urology business unit, within MANTA, within the Interventional Access business unit. And obviously, we always have new products in the works and the mix. Ironically, one product that got a benefit from the COVID-19 was our ISO-Gard Mask, which is a product that we had actually developed to stop clinicians re-breathing gases from a patient. And we that product is now, we’re getting ready to submit it for an emergency authorization to combat COVID. The only other product I could think of that could be impacted would be EZPlas, where we did submit the data to the FDA, and we were expecting to meet with the FDA in, we’re supposed to submit in March and meet them in April. We actually submitted our data at the back end of February. But the meeting with them has been pushed back. So we’re now trying to reschedule that for either May or June.
Operator:
Our next question comes from the line of Brian Weinstein from William Blair.
Brian Weinstein:
You’ve talked a lot about the elective procedure side, but we’ve obviously been hearing a lot on nondeferrable procedures, things like even appendicitis cases, MI patients are down, cancer diagnostics are, companies are telling us that new patients are obviously being impacted there as well, fewer cancer diagnosis. So trauma may be done with fewer people out and about. I appreciate you don’t want to talk too much about April here, but are you seeing an impact on the other 2/3 of the business right now that would kind of jive with what we’re hearing in general about these nondeferrable type cases?
Liam Kelly:
So what we’re seeing from our perspective is the COVID impact other than that, we have not seen any impact from what you’re describing. And right now, given the situation is pretty fluid, Brian, it would be difficult to parse out what’s this impact, what’s that impact. But from what we’re hearing from our frontline people who are engaging with the customers, it’s either COVID or non-COVID, any procedures that are being postponed are more than being offset in that scenario. Any procedures that are being postponed are being more than offset by patients that are coming in because of the impact of COVID. And the parts of our business that are impacted, obviously, by procedures is so small. But people will still get a heart attack. You’ll still need the EZ-IO. If you’re being brought into, following that heart attack, into the emergency room, you’re still going to need a laryngeal mask. You’re still going to end up in the intensive care unit. You’re still going to have a PICC or a CVC placed and you’re still going to have to be put onto a ventilator, and you’re still going to have to use one of our ventilation circuits and our humidification system. So that’s our typical flow of a patient. So if an individual has a heart attack, I think it’s still highly unlikely that they’re going -- they’re not going to go to the hospital or call the ambulance even in this environment.
Brian Weinstein:
Okay. And then just to follow-up on an earlier question regarding kind of inventory levels and whatnot. I’m curious, specifically, if you’ve seen ordering patterns from distributors, change all that much at this point outside of COVID-19 products. Are they working down inventory stocking up Are we going to be on the call the next quarter or the quarter after that and hear about changes that were going on with the way that your distribution partners are managing your products?
Liam Kelly:
Yes, thanks. So, what we saw in January and February, was we saw destocking by the distributors, Owens & Minor, Cardinal, those types of distributors. And on a full quarter basis, there was a destocking. Distributors did not react to the COVID crisis as nimbly as one might have anticipated. So we did see cumulative destocking for our businesses within the quarter. The business that was impacted the most was our Vascular business and our Anesthesia business.
Operator:
Our next question will come from the line of Dave Turkaly from JMP Securities.
Dave Turkaly:
Liam, obviously, you sit in a seat where you have a lot of conversations that are -- could be beneficial to a lot of us if we could sort of have some of the similar discussions. You gave us a lot of color. So, thanks, for that, the back half of March. I’m going to assume that April was similar. And again, it’s nice to know that you’re more on the critical care, non-elective side. But not guidance, just opinion. I’d just like to ask you, as you sit in that seat today, looking forward, do you think we’ve seen the worst on the elective procedure front or do you think we’re still not out of the woods and this is going to continue?
Liam Kelly:
So, I think that as I look at the data for the occurrence of COVID-19, globally, we’ve -- and I’m encouraged by the flattening of the curves. And that data, obviously, we can all see. For me, it’s all about consumer confidence. It is all about consumer confidence. When will people feel confident to go back to an ASC, to go back to an office and go back to a hospital. And as I sit in my chair, and thank you for all the nice words about me. But I don’t have a crystal ball unlike anybody else. And I think it’s all about consumer confidence. Now I know that people are and I know clinicians are eager to get back to work because they think that there’s a lot of damage being caused to people who are having mild strokes are not going to the emergency room, and I’m encouraged by the fact that states are reopening. As I said, when I was talking about UroLift, in the coming weeks, states that represent 60% of our UroLift revenue will be reopening. Now the next part of that is consumer confidence. And that, to me, is critical, is the consumer being confident enough to come back in and have procedures done.
Dave Turkaly:
And I know you mentioned two of the facilities that you have, where there was some -- it sounds like sort of a minor impact. But can you just remind us, I know you got a ton, but I guess, an overview of how many you have, I imagine, and they’re considered essential, but even here in the Americas, are you manufacturing at capacity in most of your other facilities? And has there been any COVID impact at any of the other ones? So our 3 strategic locations that I can put it that by geography are Mexico, the Czech Republic and Malaysia. Malaysia, we just got word a few days ago that we can ramp up to 100% capacity. We were at 50%. We had enough inventory in the channel to allow us to focus the 50% capacity on COVID-related products. Now as we ramp up to 100%, we will be able to replenish the stocks that we drew down on. We obviously manufacture in multiple plants in the United States. The twin cities is an area that we’re focused on in all of those facilities. Every facility we have is in Americas is up and running. The Malaysia was at half capacity and our plant in India was closed, and we anticipate that reopening in the near future. But we have sufficient inventory to carriers for that Indian facility as well, just to be clear.
Operator:
And our next question will come from the line of Matthew Mishan from KeyBanc.
Matthew Mishan:
Liam, I just want to better understand the OEM, and I’m sorry if I missed it, but how much of the increase was from the HPC acquisition? And were customers just stocking inventory out of supply chain caution there?
Liam Kelly:
So as I said, it grew 17.5%. It’s about half and half. Half of it comes from HPC and about half of it coming from our core business. Our OEM business is supplied to other companies. So you don’t normally get the stocking up impact from an OEM business. It was business as usual. Now the one impact that you see there in the growth rate is as a result of the sterilization. If you recall, OEM was impacted because of getting certain products to that Atlanta sterilizer. So we did get some of that product flushing through within this quarter, quarter 1. And that’s the only impact, I think I called out for OEM.
Matthew Mishan:
Okay. And then, Tom, on cash flow, I mean, you can see the continued consideration in the pension payments in the quarter, are those the primary one-offs for 2020? And how are you thinking about like the inventory build that you’ve been doing normalizing through the course of the year?
Thomas Powell:
So those are the primary one-offs. And I would say that in terms of inventory, we did build up inventory a little bit in the first quarter, some last time buys and also stocking to be ready for, having sufficient inventory to get to the COVID situation. So as we look towards the rest of the year, we wouldn’t anticipate a broad scale continuation of build with one exception. We will continue to build UroLift. Our days of inventory on hand had been only about 15 days, and we look to increase that so that we’ve got an ample supply of that product available, should there be a pretty significant ramp after we do get past the elimination of elective surgeries, if you will. So I would say with the exception of that, we don’t anticipate continuing to build inventories. Now with that being said, we’ve got to a better, have better visibility towards where demand is and make sure that we’re meeting up with that until we get that precise visibility, we could see some one-offs up or down either way.
Operator:
Our next question will come from the line of Kristen Stewart from Barclays.
Kristen Stewart:
I hope you’re all well and safe wherever you are. I just wanted to go back to UroLift, not to be the dead horse, but I just wanted to get a better understanding of the split. I know you have said the majority are done in an office or ASC setting. Can you maybe just help us understand what the split is in the office? I was under the impression most is done in ASC. And then I know you had commented, I think it was to David, that the average age was kind of around 60. Is that fair then to assume that the majority from a payer perspective is more a managed care payer? And what do you estimate kind of the average co-pay might be? And would there be any concerns there from an economic basis, if we were to have more of a recession kind of factor, this COVID period?
Liam Kelly:
Okay. So roughly, it’s evenly split of the 60%. It’s roughly evenly split between the ASC and the office. So we don’t, it’s not really weighted to one side or the other. And a lot of the ASCs, in all transparency look like an office environment for the most part. With regard to your question on the average age, so the private insurer pay, if I recall correctly, is around 30-ish percent of the total. And identifying the procedure requirements a little bit earlier has been something that we have been investigating with some clinical trials. Regarding if a recession comes into being, is there a co-pay? There is a co-pay, for sure. But as we all know, that is common across all payment methods today. And it’s just, I think, a fact of life that we spend more on health care once we get beyond the age of 55, and that shouldn’t, so from the age of 50 to 65, you’re going to spend about 10% of your total expenditure on health care in your lifetime. From 65 to 85, you’re actually going to spend about 60% of your health care. And that phenomenon has been around through multiple recessions. Without having that significant an impact. And you’ve got to balance the co-pay with the discomfort of the patient is feeling from having BPH. And if they’re in urinary retention, I mean, you’re catheterizing yourself 10 times a day. And then the overall health care economics for the system, by having a BPH procedure, the overall cost of treating that patient goes down by taking them a off farm or not having them to have an acute procedures. So I think the health care economics argument for the UroLift is probably one of the strongest, which is why the product has been so successful.
Kristen Stewart:
Okay. And then just to clarify, you said in the last two weeks of March, UroLift sales were tracking down 64%, that’s on a year-over-year basis?
Liam Kelly:
No, no. From -- if you take the first 11 weeks and then you compare the last 2 weeks to the first 11, it’s down 64% in those last 2 weeks compared to the first 11, Kristen.
Kristen Stewart:
Okay. So that’s not year-over-year? Got you.
Liam Kelly:
No.
Kristen Stewart:
Okay. That’s helpful. Would you be willing to share what it is on a year-over-year basis, I guess? Or just to give perspective on that?
Liam Kelly:
I actually don’t have it -- I don’t know what it was. I thought it a better metric. And the reason I thought a better metric is for the investment community to understand what were we doing before COVID had its impact. So, the business was growing over 38% in that first 2 months of the quarter. And then I thought what the investment community would benefit most from, what happened in the last 2 weeks compared to the first 11. So that’s why I thought it was appropriate to share that metric with the investment community to give them a flavor of what we saw on the ground with the UroLift procedure.
Kristen Stewart:
Okay. So relative to that rate, the rate -- the change then from that point, then declined 64%.
Liam Kelly:
Yes. And let me give -- I’ll give you the growth rate by month, Kristen, if this helps you. This is on a year-over-year basis. So, IUB, the UroLift grew over 38%, as I said, in January and February, and then it declined 3.3% in March.
Operator:
And I’m not showing any further questions at this time. I’d like to turn the call back over to Jake Elguicze for any closing remarks.
Jacob Elguicze:
Thanks, operator, and thanks to everyone who joined the call today. This concludes the Teleflex Inc. First Quarter 2020 Earnings Conference Call. Have a nice day.
Operator:
Ladies and gentlemen, this concludes today’s conference call. Thank you for participating. You may now disconnect.
Operator:
Ladies and gentlemen, thank you for standing by and welcome to the Fourth Quarter 2019 Teleflex Incorporated Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions]. Please be advised that today's conference is being recorded. [Operator Instructions]. I would now like to hand the conference over to your speaker today, Mr. Jake Elguicze, Treasurer and Vice President of Investor Relations. Please go ahead, sir.
Jake Elguicze:
Good morning, everyone, and welcome to the Teleflex Incorporated Fourth Quarter 2019 Earnings Conference Call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing 855-859-2056 or for international calls 404-537-3406, passcode 5857007. Participating on today's call are Liam Kelly, President and Chief Executive Officer, and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks, and then we'll open up the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. With that said, I'd like to now turn the call over to Liam.
Liam Kelly:
Thank you, Jake. And good morning, everyone. It's a pleasure to speak with you today. The fourth quarter 2019 capped an excellent year for Teleflex as, during Q4, we once again generated upper-single digits constant currency revenue growth, but also achieving the highest adjusted gross and operating margins since becoming a pure-play medical device company. During the fourth quarter, revenues grew 7.1% on a constant currency basis. And like the first nine months of the year, during Q4, the strength in our top line performance was once again broad based and included 54.4% growth in Interventional Urology, 6% growth in Interventional Access and 4.6% growth in Vascular Access, while from a geographic perspective, we achieved particularly strong growth within the Americas where constant currency revenue growth was 11.7%. Fourth quarter constant currency revenue growth also included the benefit from one additional selling day. However, this was offset by a headwind resulting from the shutdown of a facility of one of our third-party sterilization providers during the quarter. From a full-year perspective, 2019 was the first year of our three year long range plan. And I am pleased that we were able to exceed our LRP constant current revenue growth expectations as our Interventional Urology business grew approximately 48%, our Interventional Access business grew approximately 10%, our OEM business grew approximately 8%, while both our Vascular Access and Surgical businesses each grew approximately 6%. Additionally, during 2019, we were able to proactively pull forward investment spending that we expect will pay benefits in future years. Finally, we ended the year with an adjusted gross and operating margin profile that provides us confidence in our ability to achieve our previously provided long range targets. As we transition into the second year of our LRP, we remain confident in our ability to generate significant constant currency revenue growth, margin expansion and adjusted earnings per share growth. And last, I am pleased to announce that, on February the 18th, we completed the acquisition of privately-held IWG High Performance Conductors, Inc., or HPC, an industry-leading manufacturer of highly engineered, minimally invasive medical solutions. HPC is expected to be accretive to our constant current revenue growth rate and our adjusted operating margins. Importantly, we also expect this acquisition to be accretive to our full-year 2020 adjusted earnings per share. With that as an overview, let's now review quarter four revenue in more detail. I will begin with a review of our reportable segment revenues. And unless otherwise noted, the growth rates I will refer to are on a constant currency basis. The Americas delivered revenues of $400 million in the fourth quarter, which represents an increase of 11.7%. This was driven by our Interventional Urology, Surgical, Interventional Access and Vascular Access product categories. But on a full-year basis, the Americas grew 10.6%. Moving to EMEA. It reported revenues of $145.9 million in the fourth quarter, which represents a decrease in 0.6%. The decline in EMEA revenue was in part due to the timing and phasing of certain distributor orders. On a full-year basis, EMEA grew 2.7%. Turning to Asia, revenues totaled $80.5 million in the fourth quarter, which represents an increase of 2.7%. From a product standpoint, growth was strongest within our Interventional Access and Anesthesia categories, while from a geographic perspective, our business in China grew 8.5%. This was somewhat offset by weakness in Australia, New Zealand and India. On a full-year basis, Asia grew 6.8%, led by growth within China of 11.5%. And lastly, our OEM business reported revenues of $54.6 million in the fourth quarter, which represents an increase of 4.3%. On a full-year basis, our OEM business grew 8.2%. Now, let me move to a discussion of our revenue by global product category. Like my comments regarding our reportable segments, my comments regarding our global product category growth will also be on a constant currency basis. Starting with Vascular Access. Quarter four revenues increased 4.6% to $154.6 million. This was driven by growth in PICCs and EZ-IO. Now to Interventional Access. Fourth quarter revenue was $112.7 million, which is an increase of approximately 6%. Growth was broad based and was driven by increased sales in complex catheters, biologics, OnControl and MANTA. It was somewhat offset by the divestiture of our catheter reprocessing product line, which had a very strong fourth quarter of 2018. Turning to Anesthesia, quarter four revenue was $85.3 million, which represents a decrease of 1.3%. It was primarily driven by a slight reduction in the buying patterns of US-based distributors. Shifting to our Surgical business, revenue increased 3.9% to $95.2 million. The increased revenue was driven by sales ligation clips. Moving to Interventional Urology, quarter four revenue increased a robust 54.4% to $89.1 million. This was a fantastic performance during the quarter, particularly considering it was up against a very difficult comparable. Our sales force continues to make excellent progress, driving physician adoption of the UroLift System as we ended the year having trained in excess of 500 new urologists, exceeding our goal of training 450 new urologists. Given that since the inception, we have trained over 20% of the 12,000 US-based urologists, coupled with an expectation that we will train at least 500 new urologists during 2020, we plan to begin a piloted national direct-to-consumer campaign as we move throughout the year. It is our belief that this campaign will further aid in creating awareness of the UroLift System and will help make UroLift the standard of care for the treatment of BPH. Transitioning to your UroLift 2. We continue to expect to begin the rollout of the UL2 during the first half of this year. And finally, since OEM was covered in [Technical Difficulty] summarize fourth quarter revenue for the businesses within our other category, which consists of our respiratory and urology care products. Revenues here were down 4.2%, totaling $89.4 million. Despite a rather robust flu season, these product categories declined as compared to the prior year primarily due to the sterilization issue that I referred to earlier. That completes my comments on quarter four revenue performance. Next, I would like to briefly discuss our recently received label expansion for the UroLift product. During January, the FDA granted the UroLift System an expanded indication for use to treat larger prostates, between 80 grams and 100 grams (sic) [80 cc and 100 cc]. The collection of data presented to the FDA demonstrated that the UroLift System treatment is safe and effective in men with larger prostates with outcomes similar to the pivotal L.I.F.T. randomized control trial. This new indication marks another exciting milestone, and is an opportunity for hundreds of thousands of more men to benefit from the UroLift system and the durable and long-lasting relief it can provide without any risk of sexual dysfunction. And finally, before I turn the call over to Tom, I'd like to take a moment to update you on the acquisition we announced this morning. On February 18, we acquired HPC for $260 million. HPC is a market leader in insulated ultra-fine wires and polyimide micro diameter tubing components and will become part of our OEM segment. This acquisition provides two highly complementary, differentiated capability platforms, including ultra-fine wired tubing components for therapeutic applications in fast-growing markets such as electrophysiology, peripheral management and pain management. The acquisition also gives our OEM business a platform with ultra-fine wire components for conducting electricity in healthcare applications. We are pleased to have been able to make this acquisition and it is expected to be accretive to our constant currency revenue growth rate and adjusted operating margin profile, both in the immediate and long term. It is also expected to be accretive to our adjusted earnings per share beginning in 2020. In closing, I would like to reiterate how pleased we were with our performance during the first year of our long-range plan. Revenue growth exceeded our initial expectations, driven by a broad spectrum of products and geographies. But on the bottom line, we were able to grow our adjusted earnings per share more than twice our as-reported revenue growth. After having completed the first year of our three-year LRP, we feel confident in our ability to achieve the goals laid out in May of 2018. I would like to thank our employees and management teams for their excellent execution and for their continued focus on reaching our goals. That completes my prepared remarks. I would now like to turn the call over to Tom for a more detailed review of our fourth quarter financial results and full-year 2020 financial guidance. Tom?
Thomas Powell :
Thanks, Liam. And good morning, everyone. Given the previous discussion of the company's revenue performance, I'll begin at the gross profit line. For the quarter, adjusted gross profit was $403.2 million versus $369.3 million in the prior-year quarter for an increase of approximately 9.2%. Adjusted gross margin increased 160 basis points versus the prior-year period, reaching an all-time high of 59.2%. The expansion in adjusted gross margin primarily reflects increase sales volumes, a favorable sales mix of higher margin products including UroLift, Vascular and Interventional Access, benefits from footprint restructuring programs and net positive pricing. Adjusted operating profit was $184.5 million as compared to $169.9 million in the prior year, or an increase of approximately 8.5%. Adjusted operating margin increased 60 basis points versus the prior-year period, reaching 27.1%, also an all-time high. Continuing down the income statement, net interest expense decreased to $16.8 million, and this compares to 23.1 million in the prior-year quarter. The decrease of interest expense primarily reflects the impact of our cross currency swap agreements. Moving to taxes, for the fourth quarter, our GAAP effective tax rate was negative 6.4% and reflects a discrete tax benefit resulting from remeasuring the relevant deferred tax assets and liabilities following our non-US legal entity restructuring undertaken as a result of a foreign tax law change that became effective on January 1, 2020. On an adjusted basis, our fourth quarter tax rate was 7.7% as compared to 11.7% in the prior-year period. That takes me to our fourth quarter 2019 adjusted earnings per share, which was $3.28 cents, or an increase of 18.4% as compared to prior year. Turning now to select balance sheet and cash flow highlights. During 2019, cash flow from operations totaled $437.1 million, up $2 million as compared to the prior year. The increase in cash flow from operations is primarily attributable to favorable operating results, partially offset by net unfavorable impact of changes in working capital and contingent consideration payments of $26.1 million. When normalizing for the contingent consideration payments, cash flow from operations would have increased approximately 6.5%. Turning to debt and leverage, during the fourth quarter, we reduced debt outstanding by approximately $90 million and our net leverage was approximately 2.4 times at year-end. Following the completion of the acquisition of HPC, our pro forma net leverage would be approximately 2.7 times. Lastly, during the fourth quarter, the company completed the redemption of its previously outstanding $250 million, 5.25% senior notes due in 2024. While this transaction is leverage neutral, it will benefit 2020 in the form of reduced interest expense. The transaction was completed through borrowings on the revolver. In summary, 2019 was a very successful year for Teleflex. We were able to raise our constant currency revenue growth expectations twice, ultimately achieving revenue growth of 8.1%. From an earnings standpoint, adjusted earnings per share increased 12.6% to $11.15. We are pleased to have been able to raise guidance during the year and then deliver full-year earnings in excess of our upwardly revised guidance. The earnings beat was particularly rewarding as to do so required us to offset a foreign exchange headwind that was approximately twice that of our initial expectation, plus greater-than-expected tariffs in China and an unforeseen issue with one of our third-party sterilization providers. And this completes my comments on fourth quarter and full-year 2019 results. Now I'll move to 2020 guidance. In 2020, we project constant currency revenue growth of between 7.2% and 8.2%. This range includes approximately 1.2% of revenue growth coming from the acquisition of HPC. Excluding the acquisition, we project constant currency revenue growth of between 6% and 7%, with Interventional Urology, Interventional Access and Vascular Access being key contributors to growth. As it relates to UroLift, we expect the revenue to increase at least 25% over 2019 levels. For 2020, our guidance assumes a 70 basis point headwind from foreign exchange, with the greatest impact being in the first and second quarters of the year. As a result, we expect our as-reported revenue to increase between 6.5% and 7.5% during 2020. And this would equate to a dollar 1 range of between $2.764 billion and $2.790 billion. Our guidance also assumes sterilization disruption will adversely affect our first half of 2020 revenues by between $5 million and $7 million. Lastly, our guidance assumes a regular headwind in China from the coronavirus of $5 million to $10 million, or approximately 5% to 10% of our full-year China business. This projection assumes that life in China returns to normal at the beginning of April. However, given the fluidity of the situation, this estimate may change as we learn more. Turning next to gross margin. During 2020, we anticipate that adjusted gross margin will increase between 65 basis points and 115 basis points to a range of between 58.75% and 59.25%. We expect gross margin expansion to be driven primarily by favorable mix of high growth, high margin products, including Interventional Urology, Interventional Access and Vascular Access, as well from continued benefits from previously announced footprint restructuring programs. Moving now to adjusted operating margin. During 2020, we anticipate that adjusted operating margin will increase between 145 basis points and 195 basis points to a range of between 27.5% 27.75%. The increase in adjusted gross margin will largely come from gross margin line, coupled with greater OpEx leverage as compared to last year. As previously communicated, we pulled forward certain OpEx spending into 2019. And as we move forward into 2020, we expect to better leverage our cost structure from both a UroLift perspective as well as from our base business. Finally, the acquisition of HPC is expected to be a minor tailwind at the adjusted operating margin line. And that takes me to our adjusted earnings per share outlook for 2020. And this slide serves as a bridge from our full-year 2019 adjusted EPS result to our full-year 2020 EPS outlook, beginning with 2019 adjusted EPS of $11.15. From an operating standpoint, in 2020, we project additional earnings of between $1.92 and $1.99 per share, or an increase of between 17% and 18%. Included in this range is a $0.06 adverse impact from sterilization. We expect to generate the significant level of operating leverage to revenue growth, favorable mix and manufacturing cost reduction initiatives. In 2020, we expect interest expense to range between $70 million and $73.5 million. And this includes an assumption that we will initially fund the acquisition of HPC to borrowing under our revolver and then term out those revolver borrowings later in 2020. The year-over-year reduction in interest expense is expected to contribute between $0.09 and $0.16 of earnings accretion Moving to taxes. During 2020, we project that our adjusted tax rate will be in the range of 13% and 14% and will result in adjusted earnings per share headwind of between $0.27 and $0.42. The projected year-over-year increase in the adjusted tax rate is the result of a greater expected mix of US taxable income, principally resulting from UroLift growth. Additionally, our assumption is that the 2020 windfall benefit from stock-based compensation is at a more normalized level versus the atypically high level realized in 2019. Turning to share count. We estimate that weighted average shares will increase to 47.5 million for full-year 2020, which is dilutive by approximately $0.11. Moving to FX, assuming a full year euro to dollar exchange rate of $1.11, FX is expected to be a headwind of approximately $0.10. And finally, we are factoring in between a $0.05 and $0.10 cent headwind associated with the coronavirus. Despite several headwinds, our adjusted earnings per share outlook of $12.50 to $12.70 is robust, representing growth of between 12.1% and 13.9% versus 2019 or a growth rate approximately double that of our expected as-reported revenue growth. And while it is not our practice to provide specific quarterly financial guidance, it has been our practice at the outset of each year to highlight some considerations regarding variability between our quarterly expectations. Beginning with selling days, 2020 has one additional day as compared to 2019 as there's one less day in the first quarter and two more days in the fourth quarter. Similar to 2019, our guidance assumes that we will realize approximately 22.5% of full-year reported revenue and approximately 19.5% of full-year adjusted earnings per share during the first quarter of 2020. These estimates reflect our expectation that Q1 will be adversely impacted by $5 million to $7 million as a result of sterilization, plus $5 million to $10 million as a result of the coronavirus, plus our expectation that FX impacts will be the greatest in the first quarter. For the adjusted EPS perspective, the combination of the sterilization item and the coronavirus are expected to negatively impact Q1 results by $0.11 to $0.16. Finally, our revenue and profitability in the first quarter will be negatively impacted by one fewer selling day, which we estimate will have a $9 million impact on revenue. So, offsetting these Q1 headwinds will be the partial quarter benefit coming from the acquisition of HPC. And that concludes my prepared remarks. I'd like to now turn the call back over to Liam for closing commentary.
Liam Kelly:
Thanks, Tom. In closing, we're excited for what 2020 holds for Teleflex. We expect as-reported revenue growth of between 6.5% and 7.5% and constant currency revenue growth of between 7.2% and 8.2%, including approximately 1.2% from the acquisition of HPC. And despite certain headwinds, we expect another year of strong adjusted earnings growth that is about double the rate of our forecasted as-reported revenue growth. Looking out to 2021, we remain confident in our ability to grow our constant currency revenue growth between 6% and 7% and our adjusted gross and operating margins to reach ranges of between 60% and 61% and 30% and 31%, respectively. That concludes my prepared remarks. Now, I would like to turn the call back to the operator for Q&A.
Operator:
Thank you. [Operator Instructions]. And our first question comes from David Lewis with Morgan Stanley. Your line is open.
David Lewis:
Good morning. Liam, I want to start with growth and maybe have a quick question on China to follow-up. But just thinking about 2020 guidance and some of the key contributors, so I noticed your NeoTract contributed half of corporate growth in 2019. You're guiding 2020 at 25%. That's meaningfully down from the 50% exit rate. And given the difference between 25% and 35% growth for you this year is a full point of growth, I guess just sort of walk us through the investments in 2020 and why be realistic for growth to decelerate that sharply? And then, related to that, just on MANTA, just give us any sense of what you're thinking MANTA market share could be in 2020? Then I have a quick follow-up on China.
Liam Kelly:
Yeah, absolutely, David. So, let me start with the growth profile of Teleflex with UroLift and ex-UroLift in 2019. So, our total growth – constant currency growth was 8.1%. The UroLift contributed approximately 4% to that and the rest of the business approximately 4.2%. now, do bear in mind please, David, that we did have that sterilization impact of about 30 basis points. So, if you were to normalize for that, the rest of the business would have grown at 4.5%. We've all always been reasonably cautious when we enter a year. As I've said many times, we are moving from the early adopter to the fast follower with regards to the UroLift product. And as such, we've always thought it should take a little bit longer to bring those new category of docs on board. Having said that, we have executed to an incredibly high level through 2019. The end market conditions doesn't change. And as we announced on the call today, we are going to do a nationwide direct-to-consumer pilot during 2020 that we think could actually help that product as we make more and more men aware of the possibility that there is a long-term, long-lasting solution with no sexual dysfunction for the impact that they have. So, we'll see how we go through the year, but it had a barnstormer of a 2019. The UroLift product, as you're aware, even accelerated as we went through the year and, quite honestly, beat all of our expectations as it ramped, and especially important to hit 54.4% when they were really up against their toughest comparable of any of the years. So, excellent execution. And I think, if nothing else, it does validate our decision not to launch the UL2 into that sales force in the fourth quarter to keep them focused on accelerating the top line The other part of your question was I think around MANTA. And I think that we completed the limited market release in Q4, and we're in full launch as of January 1. We continue to get really positive feedback and high reorder rate from the customers. And with the combination of our limited market release and continued growth in EMEA, we actually penetrated 4% of our target market of $200 million to $300 million in 2019. And we actually expect to penetrate 8% of that market in 2020. Great clinical data, as you know. 70% reduction in vascular complications. And taking the mean time to hemostasis down from 6 to 10 minutes to 23 seconds. So, we're very excited about that product as well. I think I answered all your questions, David. Did I?
David Lewis:
You did, Liam. And just quick one on China. I appreciate the commentary on China coronavirus impact for first quarter. Just more broadly, Liam, there would be multiple competitors and some loose competitors talking about China pricing developments in 2020 and beyond. One of your competitor is in the peripheral catheter segment. Just maybe talk about your China portfolio and how you're feeling about China tenders and pricing impact on your business as we look out this year and next year. Thanks so much.
Liam Kelly:
Yeah. Sure, David. So, really, when we decided on what – when we decided on what products we're going to sell into China, we're very, very selective. So, if you think back to our Analyst Day, some investors were a little surprised that our highest gross margin of any of our regions was in Asia Pacific. A key part of that is because of the products we actually sell in China. We sell the highest end of our surgical products, we sell our coated CBCs, we sell our intra-aortic balloon pumps and we sell our portfolio of laryngeal masks. All products are highly differentiated, incredibly hard to copy. And that's why I believe that our portfolio in that regard at least is a little bit unique, and we have not seen that same price pressure that we know other companies have been talking about. And I think it's down to the portfolio we sell. We sell very few of our Foley catheters, for example, because in every region that you'd be selling in, there'd be 50 competitors. Whereas if you're selling coated CBCs with antithrombogenic and anti-infectious protection, there is no competitor in that space. So, therefore, you're not under the same price pressure. So, our selectiveness in the portfolio that we sell in China, David, is really standing to us in regard to that price pressure that others are seeing.
David Lewis:
Great. Thanks so much.
Liam Kelly:
Thank you.
Operator:
Our next question comes from Larry Keusch with Raymond James. Your line is open.
Lawrence Keusch:
Thanks. Good morning, everyone. I guess, to start out, and maybe directed towards Tom, and I think, Liam, you may have said this in your prepared comments, but the punch line is that you guys still remain confident in your ability to hit the margin targets in the LRP. If I look at kind of what you have assumed for 2019, I think on the midpoint of the range, it's around 170 basis points, so that would imply an acceleration above 200 basis points of expansion in 2021. So, again, just remind us how you're thinking about that 30% to 31% range and what gets you there from where we currently are.
Thomas Powell:
Okay. Well, I think as we look at the key drivers of our margin expansion, it will come primarily from the mix of high growth, high margin products, including Interventional Urology, Interventional Access, Vascular Access, MANTA, as well as benefits from the previously announced footprint restructuring program. So, those are the key drivers of gross margin, and that's going to drop down to the operating margin. When we also take a look at the op margin, what we're seeing is really, despite the investment behind the UroLift, we continue to see their op margin accelerating dramatically as we are better able to leverage cost structure, but we'll see even more of that as that business continues to grow. And perhaps the level of investment, it wasn't as high as what we saw in 2019. So, essentially, what we're going to expect for 2021 is a continuation of these factors that are driving 2020, which is essentially mixed in the high growth, high margin products, benefits from restructuring programs, leverage of our cost structure on both the base business as well as UroLift. And so those are the key components. I would say that, as we look at this, UroLift product will be a major driver of our margin expansion.
Lawrence Keusch:
Okay, perfect. And then, maybe just on that point for UroLift and for Liam, Liam, maybe just give us – sort of a multi-part question here. But talk a little bit about the sales force adds that you've been able to make as you come into 2020 in the US. Where do you stand right now with building the infrastructure for Japan? And again, from the time you get reimbursement to when you really get things up and going in Japan, what has to happen? I think there's actually a post approval, post reimbursement study that has to be done. Thank you.
Liam Kelly:
So, Larry, thank you very much. So, let's start with sales force in the US. So, we added approximately 20 sales reps in the fourth quarter of 2019. Our original thinking was we would be adding them right about now. We pulled that forward, so that we would begin the year with a stable sales force with all the territories aligned and the team executing at a high level as they have been since we bought it. This business just continues to exceed our expectations, Larry. For Japan, we still expect to be generating revenue in 2021. We do anticipate that we will get the reimbursement approval at the latter half of this year, and therefore, generate revenue in 2021. We have pre-invested and we have feet on the street, Larry, doing market development work in Japan as I speak and we had them in 2019. Once we get the latter end of 2020, there will be some modest additional investment in order to ensure that we start generating revenue in 2021. But really, model revenue in Japan in 2021, Larry, I would ask you, rather than in 2020. And that's what we've been consistently trying to tell the investment community. With regard to the post reimbursement, yeah, there is a requirement to gather some information and we have the infrastructure in place to do that in order to submit that to the government. That shouldn't stop the revenue ramp, Larry. It's a database that we continue to actually collect data in North America as we grow as much as we did in 2019.
Lawrence Keusch:
All right, perfect. Thank you very much. Thank you.
Operator:
Thank you. Our next question comes from Richard Newitter with SVB Leerink. Your line is open.
Richard Newitter:
Hi, thanks for taking the questions. I have two. One on UroLift and then one on the acquisition that you did and how that fits into your long-range plan. Maybe just on UroLift, Liam, is the right message here – because it sounds like, all of the indicators are – things only feel like they're set to get better from a momentum standpoint. Yet, as David had asked earlier, your guidance implies pretty significant deceleration. Is that basically just predicated on an assumption that this kind of transition to middle adopter, you've quite frankly been anticipating and braced for for a number of quarters in a row that hasn't quite happened and stifled growth, that that's your kind of running assumption that it's going to hit in 2020? But if it doesn't, presumably, there should be a faster growth trajectory there? I guess, am I thinking about kind of your – what's driving that deceleration versus what you're actually seeing in reality and that discrepancy there? Is that the right way to think about it?
Liam Kelly:
Yeah, Rich. That's a good question. Rich, nothing has changed in our end markets and there's no big pull here. Let me start by saying that. There's nothing that worries Liam Kelly about that business. Secondly, let me just say. At the beginning of every year, we're always pretty cautious about moving from the early adopter to the fast follower. Now, we've tried offset that by adding more sales reps and that seems to have done the trick for us the last couple of years. But as you would have asked us to be from time to time, we're trying to be a little bit cautious out of the gate in case there's an impact from moving – the early adopters to the fast followers. But there's no big worry out there from the Teleflex team's perspective with regard to the end markets. I actually spent a full week on the road in this quarter, visiting with urologists, talking to them about the DTC that we were anticipating bringing and asking them to be ready because the one thing that we need as we do this test at national DTC is the catcher's mitt. And I've got to tell you, there was a lot of excitement from neurologists that I met. I think I must have met about 15 neurologists over a week, and there was a lot of excitement about what we were doing in the DTC campaign. And I think the onus is on Teleflex to inform men about the UroLift product being a solution to the treatment of BPH. Our research tells us that, of the men that have BPH and are under the care of a urologist, only about 5% or 6% of them are aware of the UroLift being available, and that's something that we feel that we have to address and we have to raise the knowledge of men out there about the treatment option with no sexual dysfunction. So, I think that's the way we're looking at it right now, Richard. As we go through the year, obviously, we'll update as we go.
Richard Newitter:
Okay. Thanks for the color there, Liam. And then, maybe just a follow-up here on the acquisition and as it relates to your long-range plan, what's the growth profile of HPC on the top line? And I'm assuming it's growth accretive. With the context of the 6% to 7 long-range plan, which does not contemplate any acquisitions, nor does the 30% to 31% operating margin target by 2021. Does this deal potentially put you towards the mid to upper end? Or does this kind of – how does this factor into your ex-acquisition long-range plan guidance metrics? Thanks.
Liam Kelly:
Yeah, I think you're right. Acquisitions were not contemplated in our long-range plan. I think to be balanced, Rich, neither were tariffs, neither was FX, neither was the coronavirus, neither was sterilization. And we've overcome all of those obstacles as we've exceeded on our long-range plan in delivering better top line growth and better earnings per share than we anticipated. So, like any long-range plan, there's headwinds and tailwinds. This was not in our long-range plan. You're absolutely correct. It is accretive to our top line growth. It's actually accretive to OEM's top line growth and it is also accretive to our op margins. And that's obviously why we were keen to get this. But more importantly, I think for our OEM business, it gets us into a really nice space. It gets us into this thin-walled, wire reinforced catheter space that is growing rapidly because the catheter space is moving, catheters have to get smaller and they have to have more torque. And if you're going into neuro procedures, interventional radiology, interventional cardiology, structural heart, peripheral and EP procedures, this is the type of technology that you must have and it was a gap within our OEM business. And we couldn't be happier to have closed it just a couple of days ago.
Richard Newitter:
Thank you.
Liam Kelly:
Thanks, Rich.
Operator:
Thank you. Our next question comes from Shagun Singh with Wells Fargo. Your line is open.
Shagun Singh:
Thank you so much for taking the question. I wanted to touch on UroLift's strong performance in Q4. Can you share some metrics with us such as the utilization rates you're seeing within your current customer base, growth in new customer onboarding, as well as the DTC initiative? And then, specifically on the DTC initiative, Liam, I believe you had indicated that you were looking for a critical mass of physicians trained, about 6,000 or so. So, the news comes kind of ahead of expectations. Can you elaborate on the national – on the going national with the DTC initiative? How expensive is it going to be? And if it goes well, would you plan a full launch in 2021? Typically, it's associated with an uptick in – meaningful uptake and growth, so any color that would be helpful.
Liam Kelly:
Okay. There's a lot there, Shagun. So, I'll try and do as many as I can. So, on your first point, about 60% of our growth continues to come from existing customers, with 40% coming from new existing customers that we bring on. I can tell you that we have continued to see, since we bought this acquisition, same-store sales ramp quarter after quarter after quarter. And that's one of the indicators that we look for, is the same-store sales and how they ramp. Regarding your part of your question on DTC, we did want to have a catcher's mitt, Shagun, [indiscernible] competitors that we were thinking of doing this. So, that's why we were being a little bit more coy than normal as we were talking about this. As we sat back and done the analysis of our geographic coverage, we believe we have sufficient urologists trained out there, so that patients will be able to find the urologists in every part of America following the DTC campaign. If you go back to 2018, we did six DTCs, six regional DTCs. Then, last year, we did 16 DTCs. So, we've actually got a good base of knowledge on the direct to consumer campaigns. It will be a mixture of television campaign, focusing on some of the cable channels, CNN, Fox News, the Golf Channel, and so on, so forth. But a bigger part of it will be on the complementary digital Facebook ads, Google, PPC, web med, and all of those type of areas. We're very excited to launch this pilot. It will kick off in Q2 and we will monitor the results. The experience that we got from our regional campaigns was we got a nice uplift in men seeking treatment for BPH in those areas. So, if that is the same result we see with the national campaign, then we will consider our options, Shagun, to roll it out more broadly in later 2020 and into 2021. But that would be supported by the revenue growth that the campaign would bring.
Shagun Singh:
I got it. Thank you. And if I could just follow-up, there's about 400 basis points of gross margin expansion opportunity with UroLift 2.0. But it won't be launched, I believe, until May 1 because you're making some visualization changes. So, Liam, could you elaborate on what the changes are? And, Tom, how much of the positive impact from this transition to gross margin should we expect in the second half of 2020? Thank you for taking the question.
Liam Kelly:
Absolutely, yes. So, we did make some modest changes to the product based on feedback from our urologists and we believe – we just want this product to be perfect. The UL1 has such a massive reputation out there with urologists, we want the UL2 to be perfect in every way and we believe that this modest change will actually even help the adoption move even quicker. So, we're confident in getting that product launched, getting the 510(k) in Q2 and beginning to do some procedures. It's one of the reasons why some of our margin expansion is a little bit back-end loaded into 2021 because that's when the [indiscernible] of the conversion will take place. So, I'll let Tom go into the details on that.
Thomas Powell:
Right. I think that's the right way to think about it, is that we expect to get the UL2 out midway through this year, but the real benefit we expect to be realized in 2021. So, we're modeling just modest benefits as a result of the beginning of that conversion in 2020.
Shagun Singh:
Thank you so much.
Liam Kelly:
Thanks, Shagun.
Operator:
Thank you. Our next question comes from Matt Taylor with UBS. Your line is open.
Matthew Taylor:
Hi. Thanks for taking the question. I wanted to dig into the sterilization issue a little bit. When we talked a month or two ago, I thought that most of that was going to be resolved. So, just wanted to understand the new things that have popped up here. And in terms of your forecast for the headwind from sterilization, what are the factors that could cause that to be better or worse than expected this year?
Liam Kelly:
Yes. So, first of all, let me begin by saying, Matt, that the impact of the sterilization capacity issue is contemplated in our 2020 guidance that we communicated today. So, that's the first thing. As we said in our prepared remarks, we expect the revenue impact to be $5 million to $7 million and approximately $0.06 in EPS impact. And the product categories impacted are Surgical, OEM and the other category for our urology products. What we discovered as we went into the – early in the first quarter was that it took, though, a little bit longer than anticipated to re-validate some of the cycles. So, we do get this bit of an overhang into the first quarter. Now, $5 million to $7 million, it's not that significant an impact for a company of our size anymore. I think that negating factors are we still have one cycle to finish that should finish the revalidation in early March and we fully anticipate that to happen. And we feel pretty good about our current estimate that we have in our plan and baked in. It does hit the first quarter. And I think the broader point, I think I'd like to make too, Matt, if you give me a second is, we've got two impacts in the first quarter and one less billing day. And then, as you go through the year, what one would expect to see is once corona, sterilization and the day is behind us, what you'd expect to see during the year, you'd expect to see MANTA ramp, you'd expect UroLift to continue to demonstrate strong growth as well as Vascular, APAC and OEM. We'll, obviously, have the acquisition booked into the OEM business there. And then, as you get through the year and head into quarter four, you pick up that one billing day and then an additional billing day in the fourth quarter, which would have a revenue impact. So, thanks for allowing me to expand on that there, Matt.
Matthew Taylor:
Thanks, Liam. And then, I guess I was hoping you could spend another minute on the acquisition for an OEM business. It's not an insignificant multiple. I was just curious if you could talk about the capabilities that you're bringing online. Is that just something that you're going to be able to grow with some growing categories in OEM with or can actually use the capabilities and products that you make with that acquisition to come out with your own products? Can you talk about the outlook for that business a little bit more?
Liam Kelly:
Yes, absolutely. And first on the multiple, Matt, you're obviously calculating the multiple on revenue. I'll tell you it's a very attractive multiple on adjusted EBITDA. So, I think that we look at this as an OEM acquisition to put capability into that OEM business. We bought a small OEM business few years ago called CarTika and what we discovered following that acquisition was it was a win-win. We were able to leverage their customer base in order to accelerate some of our growth and vice versa then, take our customer base and leverage their product portfolio. And it's the same play here again. As I said earlier, the smaller thin-walled reinforced catheters are the fastest growing space in the catheter business in the OEM space. So, therefore, we expect this business to be a accretive to even OEM's growth [indiscernible] Teleflex.
Matthew Taylor:
Great. Thank, Liam.
Liam Kelly:
Thanks, Matt.
Operator:
Our next question comes from Anthony Petrone with Jefferies. Your line is open.
Anthony Petrone:
Thanks. Maybe two quick ones for me here. Just on UroLift, I'm wondering what percent of the market the larger prostate indication actually opens up, and so how much of a benefit that indication specifically will have as you move forward? And then, the second will be on MANTA. The outlook there, Liam, I'm kind of wondering what's baked in for the low risk TAVR indication as well as the new TAVR centers coming online, following the [Technical Difficulty] not contemplated in the long-term guidance. Thanks.
Liam Kelly:
You broke up a little bit at the end.
Jake Elguicze:
When we last spoke, the low risk TAVR was not necessarily considered in our market size for long-range plan.
Liam Kelly:
Okay. Thanks, Anthony. So, first of all, the UroLift, let's go there. That's about 3% to 5% of the patient population would be covered by that. I think that would expand the market to that level. Also, the way to look at it is, in the past, the urologists, if they scoped a patient and they saw a larger prostate, they may have decided to go for a TURP or another option, whereas this just expands that market and it just makes it easier for the fast followers. It just removes one other objection for our sales force. With regard to MANTA, we're still working on the basis that the market is about $200 million to $300 million. We didn't expand it for those lower risk TAVRs, which might add another 10% to the bottom and the top end, Anthony. But what we know today, the 690 TAVR centers in the US, in our fact finding and our limited launch, we know it's going to take us 10 cases to train an interventionalist, five proctored and five observed, and a busy center does around 300 cases. So, we think we've been thoughtful in the way we've laid it out. We've got 4% – let's take the midpoint of that – let's take $250 million. We've penetrated about 4% of the global market and our plan is to penetrate 8% by the end of this year. So, that's our goal. And, obviously, again, we'll update it as we go on our progress. But we couldn't be more excited about that MANTA product. It's doing really well out there and very positive feedback from the customers.
Anthony Petrone:
That's helpful. Thanks.
Liam Kelly:
Thank you.
Operator:
Our next question comes from Matthew Mishan with KeyBanc. Your line is open.
Matthew Mishan:
Good morning and thank you for taking the questions. Liam, you saw UroLift sequentially accelerate, but what I consider to be the two other sustained growth drivers for Teleflex, which is Interventional and Asia, both sequentially decelerated through the year. And I'm just trying to understand what drove the deceleration there. Is the GuideLiner portfolio slowing down some in Interventional and are you just like an in between period where MANTA is ramping and a RePlas approval?
Liam Kelly:
Yeah. So, first of all, on our complex catheters, which is the segment that we book the GuideLiner, we have not seen any slowdown in that segment. It actually had a very robust year. I wouldn't worry too much about the interventional area, Matt. There's a couple of things going on there. We book our intra-aortic balloon pumps in that business. So, the intra-aortic balloon pumps had a really good Q1, Q2, solid Q3, capital spending was a bit light in the fourth quarter. So, even though that business grew in the mid-teens, in the fourth quarter, it was in the low singles. So, there is a dynamic. And the other big dynamic that's going on in that business is the business that we sold had a really good Q4 last year. I think they did about $3.5 million. So, you're on a top comparable with that business year-over-year. So, those are the two businesses. I couldn't be happier with that business. That interventional business grew 10%. And we've been saying all year that it will either do the high-singles or sneak into the doubles and really happy with the performance there. Regarding Asia, Asia was pretty much in line with what we wanted as well. Grew 7% on a full-year basis. In the fourth quarter, we did see a little bit of softness in Australia, New Zealand and in India. Just end-of-year stuff that didn't come in as fully as anticipated, but not in a big way. It was a very modest surprise in those two areas, is the way I'd characterize it.
Matthew Mishan:
Okay. And I apologize if I missed it, but what was the operating cash flow and CapEx guidance for 2020 and how does that compare to where you thought it was coming in in the 2019 to 2021 plan?
Thomas Powell:
So, as we think about cash flow from ops for 2020, we would expect that to be in the range of $485 million with CapEx of about $110 million. If we look back versus what we expected during the LRP timeframe and the guidance we provided, we're below that for a couple reasons. The largest factor is contingent consideration. So, as a result of the performance of NeoTract, in 2020, we will pay approximately $80 million in contingent consideration above what was previously expected. Or I should say, the cash flow from operations impact is about $80 million from that. In addition, we put in a couple of new restructuring programs in 2019. And the restructuring expense, the cash expense as well as some of the CapEx is about $27 million related to that. And then, finally FX has impacted us by almost $40 million as well as the LRP expectation. So, we've had a couple large factors that are causing us to be underneath where we'd expect it to be. I'll say that obviously the contingent consideration winds down as we get into 2021. It will be down significantly from about $80 million this year and that will benefit us as we look at our free cash flow as we go into next year.
Matthew Mishan:
All right. Thank you very much.
Liam Kelly:
Yeah.
Operator:
Thank you. Our next question comes from Matthew O'Brien with Piper Sandler. Your line is open.
Matthew O'Brien:
Thank you. Good morning. And thanks for taking the questions. Tom, I'm not real good at math, but can you help me on the accretion side from the acquisition. I'm getting just over a dime accretion. And within that question, what I'm trying to ask a little bit more about is on the DTC side with the spend that you're going to be doing this year because the guidance range, if you did get about a dime of a benefit from the deal, is a little bit below what the Street is modeling. You have a big tax headwind and then you've also got this DTC headwind that I don't think people were expecting. So, I'm trying to get a sense for when you kind of net out some of the puts and the takes on the spending side of things, what EPS growth will look like?
Liam Kelly:
As I think about Iceman, did you say that you're getting $0.10 of accretion?
Matthew O'Brien:
Little more than that, yeah.
Liam Kelly:
Okay. So, as we look at Iceman, I would say that that's probably above our expectation. We're expecting some modest accretion. And relative to that, it's really dependent on the financing, how quickly we term out that revolver borrowing and what rate we're able to achieve. So, I would say that that's probably a little bit of a difference. And then, help me to understand, are you trying to factor out some of the one-off items and do an adjusted EPS or…?
Matthew O'Brien:– :
Thomas Powell:
Okay. So, as we think about the spend on UroLift in 2020, if we look at the total digital spend excluding DTC and then layer in DTC, that spend would be up about $2 million relative to what we had spent in 2019.
Liam Kelly:
And I think, Matt, the way you should look at it really is the only unforeseen headwinds to EPS are the ones that we spoke out. All the others were contemplated as we're building our plan. So, you've got the coronavirus that we weren't anticipating, you've got the sterilization that we weren't anticipating. So, if you just add those two together and take the midpoint, you're talking about $0.10 or $0.12 or something like that in those two. And they're both going to hasten [ph] in the first quarter. With regard to DTC, we're spending more money on the DTC to do a national campaign, but that's baked into our plan already and that was in our thought process. Now, you're right, on a year-over-year, there is an increase in spend to invest behind that. It should have an impact on revenue and I think making more men aware of this condition would actually help us in the longer term. As you look at the HPC acquisition, the internal nickname for it was Iceman. So, that's what Tom was referring to a little earlier. That was the project name of the acquisition. So, the HPC is modestly accretive and dependent on what sort of financing we've put in place on that. But we're really excited about that acquisition because of the technology that it brings to us So, all in all, we feel that if we take a step back, the type of company we're trying to build here and we have built and are building is a company that if we grow, let's call it, 6% on the top, we're trying to double down in the income statement as you earnings to give you, our investors, a 12% return on the bottom. So, that's what we're trying to achieve as we lay out our plans over the next number of years.
Matthew O'Brien:
Fair enough. And then, just quickly on the follow-up, UroLift 2, Liam, I totally appreciate you want to roll this thing out slowly to get it perfect. Given how many clinicians that you have to roll that out to, should we really think about the – I'm sure you'll go slow at the back half of this year with the roll out and then a little bit more so in 2021, but the real financial impact really coming the back half of next year into 2022.
Liam Kelly:
I would expect to see an impact in 2021, Matt. The reason we want to get this perfect is to make it easier for the clinicians to actually adopt it. And the way it works out there in the marketplace with our sales reps, though not in every case, obviously, but they do a milk run once a month to revisit a urology practice and make sure that the patient outcomes are sufficient, to make sure that they don't have any issues with the product and to make sure that they're touching base with the key customer. And on that milk run, an average urologist, they'll need five cases to be trained. And that's one day's work for a urologist because they tend to stack cases. So, I think that the adoption should be facilitated by the changes that we've made. It also reduces their clinical waste, which helps improve the margins within the office or the ASC. And also, it reduces our carbon footprint. So, I would counter and say, you should expect to see a pickup in margin from that UroLift 2 in the back half of this year and then more to come in 2021, Matt.
Thomas Powell:
And then, just going back to the first question you had asked just about the earnings power, I think page 14 probably highlights nicely some of the factors that you could use if you were trying to adjust for some of these headwinds. Now, in addition to that, you'd want to consider certainly the sterilization impact, which I think we call out at about $0.06. And then, again, on the HPC acquisition, depending on when and how we turn that out will impact its accretion, but its – to Liam's point, it's modestly accretive in 2020, but I think page 14 gives you the highlights of what to consider.
Matthew O'Brien:
Appreciate the color. Thanks.
Liam Kelly:
Cheers, Matt.
Operator:
Thank you. Our next question comes from Chris Cooley with Stephens. Your line is open.
Chris Cooley:
Good morning. And appreciate you taking the questions. Maybe just a couple of quick housekeeping ones from me and then a clarification. Just on a housekeeping perspective, with leverage now on a pro forma basis at approximately 2.7 times, up a little bit here, just curious how you're thinking about the use of the cash flow going forward and your coverage ratio there. And then, similarly, on EZPlaz, I think in the past you'd hoped to have a dialog with the agency prior to this call. Can you maybe just give us an update on that point as well? Thanks so much.
Liam Kelly:
Absolutely, Chris. So, it would be remiss of me not to say that our collaboration with the FDA has been very constructive. We are all very excited about the product because we all know we can have a positive impact for the military and for civilians alike. We have actually completed all of the testing that the FDA required. You're right, Chris. We were hoping to meet with the FDA before this meeting. The FDA have actually asked us to submit all the data in March and now we're going to be meeting with them in April. That's the current schedule. And we continue to sail these unchartered waters, but I'm really happy with the progress we're making on this product. And I think that the meeting with the FDA in April should really shed some light on at least our thinking around timelines around the BLA submission. So, we're looking forward to that meeting. Your other question with regard to our leverage and use of capital, as you saw from the announcement today at HPC, we continued to use our capital to do really good strategic long-term M&A at 2.7 times net leverage. We still have capacity on our balance sheet and we're still active. And there are still assets out there that we would be interested in. So, right now, that would be our preferred use of our capital to continue to do really good M&A.
Chris Cooley:
And if I could, just maybe one other quick one, just wanted to clarify, I think in a prior question, you stated that there was only 5% to 6% of patients under treatment by urologists that were aware of UroLift. I'm curious, is that for the whole urology community or are those for the actual implanters right now? So, it would seem relatively low for the implanting community that would be active users of UroLift. If it's the latter, can you maybe talk to us about why that message isn't getting communicated within those practices?
Liam Kelly:
So, I was talking about patients, Chris. The men that have the condition.
Chris Cooley:
Okay. Thank you. That clarifies it.
Liam Kelly:
All right. Thanks.
Chris Cooley:
Thank you.
Operator:
Thank you. Our next question comes from Kristen Stewart with Barclays. Your line is open.
Kristen Stewart:
Hi. Thanks for taking the question. I just wanted to, I guess, return a little bit back to cash flows and then also just kind of talk through some of the puts and takes there. I guess when do you guys expect to kind of see a little bit more strength with cash flows? I guess, just looking through, it seems like you guys have – understand the contingent consideration accounting and how that works. But it seems like there's also a lot just kind of coming through it, some of the one-time costs with acquisition integration and restructuring. And it also looks like you guys have some estimated cost in for MDR as well that seems to be higher than I would have anticipated in the 2020 numbers too. Can you maybe just shed a little more light on cash flow improvement going forward and expectations there? And then I have a follow-up. Thanks.
Thomas Powell:
Sure. And, Kristen, I think you've touched on the key point, is the contingent consideration as well as FX and some of the new restructuring programs that we've put in place. As we look at some of these the restructuring programs, our use of cash now, obviously, we put them in place because we see that as a longer-term capability to drive margin expansion as well as future cash flow. As we look to where we'll start to see an acceleration, we believe that 2021 will show marked improvement in some of the factors that will cause that. It's just the level of contingent consideration will go down from about $80 million in 2020 to 25-or-so-million in 2021. We'll also see an increase, obviously, in our net income. And then, we will have – as we continue to build the business, we've put more inventory into the channel right now in order to help with back orders. As we go into the next couple of years, we actually see inventory coming down a bit for two reasons. One is a lot of the footprint moves are going to be starting to be behind us and so the strategic builds to transition from one facility to another will start to go down and we also have some programs in place to greater improve our S&OP processes and otherwise to help take down those inventory levels. I'd also say, another area we'll see some improvement is just in CapEx. So, our CapEx has been elevated in 2019 and 2020 in part due to the manufacturing footprint moves in having to fit out those new locations. So, those are the key areas that we'll look to see driving future cash flow growth. But really 2021 is a year where you should see some nice acceleration relative to what we see in 2019 and 2020.
Kristen Stewart:
And then, what about the MDR costs, those seem to be pretty high for 2020. Is that just kind of a one-time measure, getting in compliance with those new regulations?
Thomas Powell:
Well, that's actually a multi-year program. So, we do have a considerable amount of expense in 2020 relative to 2019, but that will even carry out for a couple of years beyond that as we fully implement.
Kristen Stewart:
Okay, thank you very much.
Thomas Powell:
Yeah.
Operator:
Thank you. Our next question comes from Dave Turkaly with JMP Securities. Your line is open.
David Turkaly:
Thanks. I've got two quick ones here. First, you highlighted a reduction in buying patterns of US distributors in Anesthesia. I just wondered if you could give us color on what that is and when it reverses. And then, secondly, I'll just fire it out there now. I think, in Asia, you highlighted price increases is driving the majority of the 2.7% CC increase. I was just wondering if you could give us some color on why you're able to do that and where exactly you're gaining that net price. Thanks.
Liam Kelly:
So, I'll start with the pricing. So, the pricing in – or the growth in Asia-Pacific, within the quarter, was, you're right, 2.7%, but I don't think we said that was all – that's mostly volume. So, that's really volume of our Interventional Access, our Vascular Access products, it's where the growth is coming from there. From an enterprise-wide, from a company, on a full-year basis, you are correct, we did get about 30 basis points of positive pricing as an organization. That's really coming from a few areas. Our Surgical business took a one-time pricing opportunity, and that was able to drive some pricing. In our Vascular business, in our Interventional business and in Asia Pac, there was positive pricing. The negative pricing normally occurs in respiratory and in EMEA. But if you add it all up, it was positive this year to around 30 basis points, Dave. The other part of your question is around the buying patterns. So, what we saw there in Anesthesia was $2 million to $3 million of destocking in the fourth quarter. That normally comes back. I think that, on a full year basis, we did see some destocking as an enterprise from these distributors, but it's a smaller impact for Teleflex anymore, Dave. It's just because, in the past, half our business used to go through these distributors and now only one-third and it's a modest impact to Teleflex as a whole and in the fourth quarter and with the bulk of it sitting within Anesthesia.
David Turkaly:
No, thank you. It was the buying pattern comment versus the timing. So, thank you for that.
Liam Kelly:
All right, no worries.
Operator:
Thank you. Our next question comes from Mike Matson with Needham. Your line is open.
Michael Matson:
Thanks for taking my questions. Most of them have been answered, but I just had a couple more on the DTC campaign for UroLift. So, one, I guess, just from a timing perspective, when you've done the trials with the ads, how long does it take from when the ads run to when it reflects in your revenue? And I'm just wondering if you're going to potentially see some front-end increase in spending before it starts translating through to growth. And then two, you mentioned that it drives just awareness of BPH in general, which obviously will drive more patients to get UroLift, but it might bring in more patients to the competitors as well. So, do you think you can kind of steer them more to UroLift as opposed to some of the other things that are out there? Thanks.
Liam Kelly:
So, let's start with the last one. So, our goal, Mike, is not to run DTC to help our competitors. Let me start by saying that. The ads will be very focused on some of the uniqueness of the UroLift product and it really comes back to all of the clinical evidences out there. There is no other product that you can offer to a patient that has zero new onset of sexual dysfunction and that's going to be a key message that's going to be communicated out there. For sure, what will happen in real life is, as a patient comes into the urologists and as the urologists scopes that patients, if they have issues with their bladder more so than with their prostate insofar that a TURP is required, then that could be an occurrence. And actually, Mike, that won't be a problem for us in Teleflex. As long as the man gets the best treatment option for him to have the best possible outcome, that will be fine. But we've seen with our regional DTCs that the majority of patients are applicable for the UroLift product and I don't think it's going to be any different when we go nationally. With regard to how long it normally takes, it really depends on the urology practice. Once a man engages with the urology practice, you would expect them to schedule that procedure within the timeframe of about four to six weeks. Once it goes beyond six weeks, I think that – our feedback has been, you tend to get a bigger drop off, but we are communicating with the urology community to make sure that they are prepared and ready for this campaign, and that's what we've been doing since the beginning of the year.
Michael Matson:
Great, thank you.
Operator:
Thank you. And that's all the questions we have for today. I'd like to turn the call back to Jake Elguicze for any further remarks.
Jake Elguicze :
Thanks. Thanks, operator. And thank you to everyone that joined us on the call today. This concludes the Teleflex Incorporated fourth quarter 2019 earnings conference call.
Operator:
Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.
Operator:
Ladies and gentlemen, thank you for standing by, and welcome to the Q3 2019 Teleflex Incorporated Earnings Conference Call. [Operator Instructions]. I would now like to hand the conference over to your speaker today, Jake Elguicze, Treasurer and Vice President of Investor Relations. Please go ahead, sir.
Jake Elguicze:
Thank you and good morning everyone, and welcome to the Teleflex Incorporated Third Quarter 2019 Earnings Conference Call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing 855-859-2056 or for international calls 404-537-3406, passcode 1185417. Participating on today's call are Liam Kelly, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks, and then we'll open up the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. With that said, I'd like to now turn the call over to Liam.
Liam Kelly:
Thank you, Jake, and good morning everyone. It's a real pleasure to speak with you again. I am very pleased with Teleflex's performance during the third quarter, as we continue the positive momentum in our business, delivering 6.3% revenue growth on an as reported basis and 8% growth on a constant currency basis. Like the first half of the year, during Q3, the strength in our top-line performance was once again broad-based, driven by improvements across nearly every global product category. This included 50.4% growth in Interventional Urology, 8.2% growth in Interventional Access, 6.1% growth in Vascular Access, and 5% growth in Surgical. While from a geographic perspective, we achieved particularly strong growth within the Americas where constant currency revenue growth was 10.7%. We saw a rebound in EMEA where constant currency growth improved to 5.1% and we drove continued steady performance within Asia, where currency-neutral revenues grew 5%. Turning to some other key metrics. In addition to delivering robust constant currency revenue growth, which we were able to achieve even when faced with a difficult prior-year comparable, I was also pleased to see the year-over-year and sequential expansion in both our adjusted gross and operating margins. And, during the quarter, our adjusted gross margin reached 58.6%, which was an increase of 160 basis points as compared to the prior year and 90 basis points sequentially. While our adjusted operating margin totaled 27%, which was an increase of 100 basis points as compared to the prior year and 180 basis points sequentially. Turning to the bottom line. Thanks to stronger-than-expected revenue and margin performance, coupled with additional benefits from a further reduced tax rate, our adjusted earnings per share during Q3 was $2.97, which represents an increase of 17.9% over the third quarter of 2018. When normalizing for the impact of FX, Q3 adjusted earnings per share grew approximately 19%. In summary, we are very happy with our better than expected revenue performance as during the third quarter, our global Vascular Access, Interventional Access and Interventional Urology businesses outperformed as compared to our prior expectations. The strong year-to-date results, coupled with our outlook for the fourth quarter has led us to once again increase our full-year 2019 guidance for constant currency revenue growth from a range of between 7.5% and 8% to a new range of between 8% and 8.25%. This updated guidance takes into consideration the better than expected performance from our Vascular and Interventional Access product line. However, this is largely offset by an issue that recently arose relating to the suspension of operations at a third party in Georgia. This sterilization issue is causing a disruption of selected Teleflex products, mostly within our surgical and OEM businesses. We are working diligently to resolve this issue to ensure patients and their healthcare providers have access to effective products. Importantly, the UroLift product is not one of the Teleflex products that is impacted by the sterilization disruption issue. Additionally, our increased constant currency revenue growth guidance range also assumes an improvement in full year UroLift revenue growth, as we now expect UroLift revenue to increase 40% as compared to our prior expectation, which called for full-year revenue growth of approximately 35%. Today, we are also reaffirming our full-year 2019 adjusted growth and operating margin guidance ranges as well as narrowing our adjusted earnings per share guidance from a range of between $10.90 and $11.10 to a new range of between $11.05 and $11.10. Our updated revenue and adjusted earnings per share guidance takes into consideration the sterilization issue I just mentioned, as well as worsening FX environment since we last reported earnings. Indeed, if we reported our full year adjusted EPS on a currency-neutral basis, our year-over-year EPS growth assuming the midpoint of our updated range would equate to a growth of approximately 16%. With that as an overview, let's now review Q3 revenue in more detail. I will begin with a review of our reportable segment revenues and unless otherwise noted, the growth rates I would refer to are on a constant currency basis. The Americas delivered revenues of $374.5 million, which is an increase of 10.7%. This was driven by our Interventional Urology, Interventional Access and Vascular Access product category. Moving to EMEA, it reported revenues of $140.5 million which represents an increase of 5.1%. On our last earnings call, we stated that we expected to see an improvement in the performance of our EMEA business and that is what occurred, as during the quarter, the growth in this part of the world was led by our Interventional Access, Vascular access and urology products. Turning to Asia, revenues totaled $77.9 million, which is an increase of 5% as compared as compared to the prior year period. From a product standpoint, growth was strongest within our Surgical and Vascular Access categories, while from a geographic perspective, our business in China grew 11.5%. This was somewhat offset by weakness in Australia and New Zealand. And lastly, our OEM business reported revenues of $55.4 million, which represents an increase of 1.9%. You may recall, on our last earnings call, we said that we expected our OEM business to show flattish growth within the quarter due to a difficult comparable as well as timing of certain orders and that is what occurred. In fact, during the third quarter, this business did a little bit better than we previously expected. Now let me move to a discussion on our revenues by global product category. Like my comments regarding our reportable segments, my comments regarding our global product category growth will also be on a constant currency basis unless otherwise noted. Starting with Vascular Access, third quarter revenues increased 6.1% to $148.7 million. This was driven by strong growth in PICCs and visual navigation products as well as growth in sales of CVCs. Moving to interventional access, third quarter revenue was $106.9 million, which is an increase of approximately 8.2%. Like the results we delivered in the first half of the year, the strength in this business during Q3 was broad based with growth in complex catheters, biologics, on-controls, intra-aortic balloon and closure products. Now to Anesthesia, quarter three revenue was $87.1 million, which is an increase of 1.5%. The increase here is primarily driven by sales in endotracheal tubes, atomization and laryngoscope products. Shifting to our Surgical business, revenue increased 5% to $92.6 million driven by sales of ligation clips and surgical instruments. Moving to Interventional Urology, revenue increased a robust 50.4% to $73.6 million. While the growth rate this quarter is somewhat inflated due to the easier comparable because of the voluntary product withdrawal we had last year, our sales force continues to make excellent progress driving physician adoption of the UroLift system, and we remain on track to trade a total of over 450 new urologists during 2019. Transitioning to UroLift 2, we continue to expect to begin the rollout of the UL 2 during the fourth quarter with a full conversion of the U.S. physician base from UL 1 to UL 2 expected in 2021. And finally since OEM was covered in our segment review, let me summarize third quarter revenue for the businesses within our other category, which consists of our respiratory and urology care products. Revenues here were down 0.4% on a constant currency basis, totaling $83.9 million. This was driven by declines in sales of our respiratory products, somewhat offset by an increase in sales of our bladder management products. That completes my comments on quarter three revenue performance. Next, I would like to briefly discuss some important clinical publications and awards concerning UroLift. First during the month of August, the UroLift System won the 2019 James & Wells Medical Technology Association of New Zealand Award. This award recognizes products that significantly contribute to improving patient outcomes by enhancing their quality of life, as well as exhibiting technical excellence and innovation across the medical device sector. This achievement is yet another example of the UroLift System superiority as compared to alternative methods to treat BPH and it should help us as we continue to try to expand the adoption of the UroLift product within the New Zealand market. Lastly, during September, the Urology Times showcased the effectiveness and benefits of the UroLift System, noting that due to shortcomings in TURP and medications, the advancement of the minimally invasive surgical technologies categories remains imperative for men seeking an effective treatment option for BPH. In the article, UroLift scores favorably, with patients reporting rapid recovery and symptom relief, preserved sexual function, low catheterization rates and low complications. That completes my comments on UroLift. Let me now provide a brief update on another product we are enthusiastic about, MANTA. For those who may not be aware, MANTA is the first commercially available biomechanical vascular closure device designed specifically for large bore femoral arterial access site closure. It helps reduce time to hemostasis without pre-closure, delivering reproducible results that help clinicians achieve successful closure. During TCT, there were several presentations regarding MANTA, as enthusiasm continues to grow for this device. Our initial limited market release and price discovery activities remain very much on-track; while account penetration, reorder rates and initial adoption in the U.S. have been strong. Full market release for this product in the U.S. will occur in January of the new year, and we fully expect MANTA to be a nice contributor to our revenue growth rates in 2020 and beyond. In closing, I would like to reiterate how pleased we are with our performance during both the third quarter, and first nine months of the year. Revenue growth continues to exceed our expectations, driven by a broad spectrum of products and geographies, which led us to increase our full year revenue guidance for the second consecutive quarter. In addition to continued top-line strength, during the quarter we achieved significant year-over-year, and sequential, gross and operating margin improvements, and we expect that to continue during the fourth quarter. And as such, we are narrowing our full year adjusted earnings per share guidance to a range of between $11.05 and $11.10. Before, I turn the call over to Tom, I'd like to take a moment to reflect on our long-range plan. We are currently nine months into a three-year journey. Our revenue growth has exceeded our initial expectations and our margin targets remain very-much on-track. We feel more confident than ever in our abilities to achieve the goals laid out in May of 2018. I would like to thank our employees and management teams for their excellent execution in the first nine months of our LRP, and for their continued focus on reaching our goals. That completes my prepared remarks. I would now like to turn the call over to Tom for a more detailed review of our third quarter financial results and full year 2019 financial guidance. Tom?
Thomas Powell:
Thanks Liam and good morning everyone. Given the previous discussion of the Company's revenue performance, I'll begin at the gross profit line. For the quarter, adjusted gross profit was $380 million versus $347.3 million in the prior year quarter, or an increase of approximately 9.4%. Adjusted gross margin increased 160 basis points versus the prior year period, reaching an all-time high of 58.6%. The expansion in adjusted gross margin primarily reflects increased sales volumes, a favorable sales mix of higher margin products and benefits from cost improvement programs. Partially offsetting these gains were negative impacts from incremental tariffs. Adjusted operating profit was $175.3 million as compared to $158.7 million in the prior year, or an increase of approximately 10.5%. Adjusted operating margin increased 100 basis points versus the prior year period, reaching 27%, also an all-time high. As the year has progressed we've realized robust sequential expansion of adjusted operating margin. The first quarter adjusted operating margin was 23.7%, followed by 25.2% in the second quarter and now 27% in the third quarter. And we expect further sequential expansion in the upcoming fourth quarter. The trend of strengthening operating margin is largely the result of expansion in the gross margin, timing of investment spending and volume leverage. Continuing down the income statement, net interest expense decreased to $19.1 million, and this compares to $26.9 million in the prior year quarter. The decrease in interest expense primarily reflects the impact of our cross-currency swap agreements. Moving to taxes. For the third quarter, our GAAP effective tax rate was negative 132.3% and reflects a discrete tax benefit of $129 million resulting from a non-U. S. legal entity restructuring that eliminated the requirement to provide for foreign withholding taxes on the future repatriation of certain non-permanently reinvested earnings. On an adjusted basis, our third quarter tax rate was 10.3%, as compared to 10.7% in the prior year period. That takes me to our third quarter 2019 adjusted earnings per share, which was $2.97, or an increase of 17.9% as compared to prior year. We are encouraged by the strong earnings generation, stemming from upper-single digit constant currency revenue growth combined with margin expansion. Turning now to select balance sheet and cash flow highlights. During the first nine months of 2019, cash flow from operations totaled $289.2 million, compared to $302.9 million in the comparable prior year period. The decrease in cash flow from operations is primarily attributable to contingent consideration payments of $26.1 million and the net unfavorable impact from changes in working capital, driven primarily by increases in inventory. The increase in inventory was in part a tactical move designed to enhance customer service by increasing safety stock levels on select products. Turning now to debt and leverage, during the third quarter we reduced debt outstanding by approximately $132 million resulting in quarter ending net leverage of approximately 2.45 times. Finally, today the Company issued a notice of redemption to holders of outstanding 250 million, 5.25% senior notes due in 2024. Pursuant to the notice of redemption, the 2024 notes will be redeemed on November 15th at a redemption price equal to 102.625% of the principal amount outstanding plus accrued and unpaid interest, and this completes my comments on third quarter results. Now I'll move to 2019 guidance updates. Given our performance for the first nine months of the year, and our expectation for the fourth quarter, we are increasing our full year constant currency revenue growth guidance from a range of between 7.5% and 8%, to a revised range of between 8% and 8.25%. As a result of prevailing foreign exchange conditions, we now expect that foreign exchange will result in a 225-basis point headwind to full year revenue, as compared to our previous expectation of a 150-basis point headwind. As such, we are lowering our as-reported revenue growth guidance from a range of between 6% and 6.5%, to a revised range of between 5.75% and 6%. We are reaffirming our previously provided adjusted gross and operating margin guidance ranges and given the favorable trend in Libor rates versus expectations and a modest fourth quarter benefit from the redemption of our 2024 notes, we are reducing our estimate for full year net interest expense to approximately $80 million. Turning to taxes, we now anticipate that our full year adjusted tax rate will fall within a range of 12.25% and 12.5%. This is down from our prior expectation of being on the lower end of the 14% to 14.8% previously provided guidance range. From a share count perspective, we continue to expect full year weighted average shares to be approximately 47.1 million. That takes me to our GAAP and adjusted earnings per share ranges. On a GAAP basis, given the third quarter discrete tax benefit and strong financial results, we are increasing our full year guidance from a range of between $6.82 and $6.94, to a new range of between $9.85 and $9.90. On an adjusted earnings per share basis, we are raising and narrowing our guidance from a previous range of between $10.90 and $11.10, to a revised range of between $11.05 and $11.10. Included in the updated adjusted EPS guidance range is a $0.07 estimated earnings impact stemming from the closure of a third party sterilization facility. Also included in the adjusted EPS guidance range is our current foreign exchange assumption of a $0.41 full-year headwind versus our previous expectation of a $0.35 foreign exchange headwind. If we reported our full year adjusted EPS on a currency neutral basis, our year-over-year EPS growth, assuming the mid-point of our updated guidance range, would equate to approximately 16% growth, which serves to reinforce the strength of our 2019 financial leverage. In closing, we are very pleased with the financial performance achieved in the first nine months of 2019. The acceleration in revenue growth is broad based, both from a geographic and a product standpoint. And despite a less favorable currency environment, we have increased our earnings estimate by also funding incremental investment. And that concludes my prepared remarks. At this time, I would like to turn the call back over to the operator for question and answers.
Operator:
Thank you. [Operator Instructions] Our first question comes from David Lewis with Morgan Stanley. You may proceed with your question.
David Lewis:
Good morning, thanks for taking the question. Just – maybe just two for me here. First, Liam, just kind of a broad commentary on the LRP and then maybe, Tom, a couple questions to you on the fourth quarter. So, Liam, look 6% to 7% was the LRP guidance perspective you offered, you are delivering kind of a point above the high end of the range here, closer to 8%, and I think about next year, you've got Manta, you've got some RePlas as well. So, as I think about next year, is the right way to think about 2020, you're going to deliver the LRP around 6% to 7% or given those product launches you can do a little better? And I have a couple of follow-ups for Liam, I'm sorry, for Tom.
Liam Kelly:
Yes. Sure David. So based on the LRP, obviously, we will get the 2020 guidance when we report our Q4 earnings in February, but I will comment, as I said in my prepared remarks on the LRP, we couldn't be happier with the progress we're making. We are only nine months in but within the first nine months of the year, our revenue growth has been incredibly solid. So, year-to-date through the nine months, we've grown at 8.4% and we've been able to take up our revenue guidance twice within the year. So we feel really confident. We've got, obviously Manta will come into play in 2020 and we also in 2021, we'll have the UroLift in Japan that wasn't in our previous guidance. So regarding the revenue line for our LRP, we feel extremely confident in the goals that we set out in May of 2018 and it's not just on the revenue line, as we've gone through the year, we've been able to demonstrate the external community that our margin expansion to the point where in this quarter, we've hit an all-time gross margin high for the company and an all time op margin high for the company showing significant leverage in the income statement, while at the same time, being able to invest in some of our businesses, in particular the UroLift product, as we continue to invest behind the sales force there and we will continue to do that also in Q4.
David Lewis:
Okay, very helpful Liam, and Tom just two for you, just first on growth into the fourth quarter, guidance implies about a point or two momentum acceleration sort of what drives the confidence to finish the year that strong? And then on earnings, just wonder if you could help us with the reconciliation, it looks like a conservative earnings number implied in the guide for the fourth quarter and there's a lot of moving pieces between tax, interest, sterilization and margin improvement. Could you just bridge us a little bit on sort of the components that drive positive or negative tailwinds into the fourth quarter, because as I said, it looks a little conservative? Thanks so much.
Liam Kelly:
So, Dave, we will get Tom to cover the EPS and I'll cover the revenue. So, on the revenue side, so first of all, you have the impact of the stabilization issues. First of all, let me just start by saying that with the sterilization capacity issue, it is contemplated in our updated guidance and contemplated it is contemplated in our updated guidance and contemplated in our raise in our revenue. We do think it's going to have an impact in the fourth quarter of about $8.7 million, and Tom will cover the EPS impact. But as he said in his prepared remarks is about $0.07, that's about a 40 basis points full year headwinds based on that sterilization issue. Regarding your question, David, on headwinds and tailwinds, obviously, we have an extra billing day in the fourth quarter. So the way I think you should look at it is the impact from the sterilization issue is pretty much washed with the billing day in the fourth quarter. Now if you take the midpoint of our guidance range in the fourth quarter, it would imply that we're planning to grow in the mid-sevens in Q4 in order to get to the midpoint of our updated guidance – at the midpoint of our guidance and we feel really confident on that and that's again against a tough comp. What I really like about the set up for Teleflex is that we are able to put forward a growth rate in the mid-sevens up against the top – a tough comp of 7.7% in the prior year. And also in this quarter, if we do a pro forma on the prior year, the growth was 8.2% and we were able to grow 8% on that. So those are really the headwinds and tailwinds, FX can go either way, and I'll let Tom now address the EPS question.
Thomas Powell:
Sure. So if we look at our fourth quarter EPS, I'd say that given the midpoint of our guidance, we're looking at 15% to 16% EPS growth. So, we look to put up another very solid quarter. Now in terms of just the third quarter performance, we came in favorable versus our internal expectations, favorable versus consensus by $0.22, and as an outcome, we raised our guidance at the midpoint, by $0.075. Now in addition to that $0.075 guidance range, we've also included in our guidance $0.06 associated with a stronger headwind from foreign exchange and a $0.07 adverse impact from the closure of the sterilization facility. So as we look into fourth quarter, we've got a couple of items that are impacting us negatively. But overall, we are pretty excited about the strength of the performance as we finish out the year, as mentioned, we're expecting earnings growth kind of in the 15% to 16% range.
Liam Kelly:
And Dave, I just wanted to add one comment on that from what Tom said. We are also investing behind UroLift in the fourth quarter, a little bit heavier than we had anticipated. We had anticipated some new sales hires that would come in Q1, we're actually going to bring in those additional headcount in Q4, so that we hit the ground running in Q1 of next year. And we're also anticipating doing additional DTC in Q4. So what I – again, what I really like about the setup is we are able to call up our earnings. We are able to call up our earnings guidance, invest behind the growth drivers in the business and offset some bad guys which the sterilization is. So I think all in all, we couldn't be happier with the performance of the business for the first nine months and our guidance would reflect that.
David Lewis:
All right, thanks for the clarity guys. Great quarter.
Liam Kelly:
Thanks, David.
Thomas Powell:
Thanks, David.
Operator:
Thank you. Our next question comes from Larry Keusch from Raymond James. You may proceed with your question.
Larry Keusch:
Perfect. Good morning, everyone. One for Liam, and then one for Tom. Liam, maybe on UroLift obviously the product continues to be strong and is outpacing the expectations that you have set through the year and perhaps you could talk a little bit as we're again moving into this phase into the fast followers, how you're kind of thinking about average procedures per physician and how that's trending and sort of where the sales force is really, really focused on making sure this continues to gain traction?
Liam Kelly:
Thanks, Larry. And we had a resounding quarter for UroLift, it grew at 50.4%, through the first nine months of the year, it's growing at around 45%. So that, you're right, the product is exceeding all of our internal expectations. This third quarter had a slightly easier comp because we had the voluntary withdrawal of the product in Q3 last year. So that has definitely helped this quarter but notwithstanding that we're incredibly focused on making this product a standard of care. Regarding the physicians, the business is incredibly stable. The average physician continues to do about four procedures a month. We continue to develop champions and we continue to make this product the standard of care. I think the number of publications obviously will help, the DTC helps and I think having a sales force Larry that wakes up everyday and only thinks about one product is an obvious advantage as we continue to drive accelerated performance. And so, as I said in my prepared remarks, I think we will definitely achieve, if not, modestly exceed the 450 clinicians we have targeted to train this year and as we move from the early adopter to the fast follower, what has been very encouraging for me in particular is that the growth has not slowed as we move to that second phase of clinician and right now we are moving into the fast follower. Our thought has always been that it will take a little bit longer to bring that clinician on board, that clinician really requires, there appears to be using the product, they require very strong clinical data. They will require real world data that is very aligned to the clinical data and they need broad coverage to ensure that they're going to get paid for the procedure and I think as we sit here right now moving to the fast follower, all four of those boxes are ticked for Teleflex Larry.
Larry Keusch:
Okay, perfect. That was helpful, Liam. And then, I guess, the question here is just want to take your temperature on your confidence in the margin expansion actually through the LRP, not for 2019, so kind of what gets you there? And how do we think about the gating in 2020 and 2021 for that operating margin expansion, just wanted to think about how we are calibrating for that LRP? And, I guess, lastly, just on that, given that your sterilization is bit of a headwind, what sort of feedback are you getting from your sterilization provider as to kind of when they think they might be able to resolve some of these issues?
Liam Kelly:
Okay. So let me take it in chunks, Larry. Let me start with the cadence of margin in our LRP, and let me begin by saying, and as I said in our prepared remarks, I'm more confident than ever in our margin expansion within our LRP. As I said, we hit an all-time high on both growth and operating margin. And where is the margin going to come from, while about 60% of it is going to come from mix, our philosophy in Teleflex that not all growth is equal and where we're growing our businesses is in Interventional Urology, Interventional Access, Asia and within our Vascular business in particular PICCs and Vidacare. All of those are accretive to our margins, and if you look at where our investment goes, Larry, it goes behind those businesses and you can see for the first nine months of the LRP, those are the businesses that are performing exceptionally well and then add-in OEM, which has had a great performance. With regard to the cadence – so that answers your question on our confidence, Larry. With regard to the cadence, what I would expect and I don't want to get into 2020 guidance as you can appreciate, but what I would expect, Larry, is that we would see more margin expansion in 2020 than we've seen in 2019. So you would expect to see further margin expansion to 2020, and then another uptick in 2021, but rest assured, there would be an uptick in both years in our margin expansion in 2020 and 2021, that would be our expectation. And then onto your question on the sterilization, we began a number of weeks ago, when this issue arose in the Atlanta area, Larry to begin to re-qualify other sterilization cycles in other areas and our partner has been working very much with us to help us to do that. They don't have clear line of sight as to when that facility may be reactivated. I think that they are working with the county officials. I think that they are I think that they are working with the EPA and, but right now we don't have line of sight. Our expectation is that we will have other cycles revalidated by quarter one and we would envisage that that would allow us to continue to supply product into the marketplace at that time. And I think what has been helpful in some of the FDA statements that have come out and the FDA put out a note last week stating that more than 20 billion devices sold in the U.S., so that is $1 billion Larry, are sterilized with ethylene oxide, accounting for almost half of all medical devices. And I think they also said, it's important to note that there is no readily available process at our facilities that can serve as a viable alternative especially when you're dealing with plastic products. So, I think that was also incredibly helpful and our associations, in particular, AdvaMed and MDMA continue to work with these local government authorities to educate them on the importance of having sterile product in the marketplace because it could have a much bigger patient risk than the ETO environmental issue, which from what I can see are very complying to the Clean Air Act.
Lawrence Keusch:
Okay, perfect. Thanks for the very detailed answers earlier. Appreciate it.
Thomas Powell:
And I just – just to add on to that, Larry, as we look at 2019 margin expansion, we believe that the business is performing incredibly well. So is the business creating financial leverage? Absolutely. However, there are kind of three factors that limit kind of the printed result on margin expansion and those are FX, that's been about a 40-basis point headwind in the year, tariffs is another 30 basis points. And then, we've made a number of investments for the future, which we believe will benefit us in the longer term, but this year, we've got expense with no real benefit and those include the market development in Japan for UroLift, the pre-launch U.S. investment from MANTA, we've got an acceleration of the UroLift sales hires through the fourth quarter now. And so that's another 65 basis points. So, if you think about it, we’ve got about 140 basis points factors that are kind of impacting this year that we believe will provide benefit for the future or perhaps go away in the future. So, the underlying operating performance of the business is very solid this year being masked somewhat by FX tariffs and some of the investments we've chosen to make.
Lawrence Keusch:
Great. Thanks for that color.
Thomas Powell:
Yes.
Operator:
Thank you. Our next question comes from Richard Newitter with SVB Leerink. You may proceed with your question.
Richard Newitter:
Hi, thanks. I have two, and congrats on the quarter. First on sterilization, I just want to ask, could you quantify or give us a sense as to what your expectation is for expenses or impact to carry over into 2020, I mean, should we be dialing in as a placeholder an impact in the first half of next year, $0.07 is a – it's a pretty big impact, I know these things take some time. Thanks for the color earlier, but that's my first question, how do we think about this impacting 2020?
Liam Kelly:
So, Rich, I wouldn't expect a material expense in 2020 in relation to this. What we are doing is working with our partner to validate another sterilization cycle either in another geography or in another size. So I wouldn't anticipate a significant uptake. The $0.07 quite frankly, Rich, is a little bit less than I would normally expect if you get $8.7 million, I would expect $0.08 to $0.09 of an impact normally. Because of the margin profile in particular of the products in the other category that helps us minimize the EPS impact, that's what gets it down to that $0.07. And obviously, we have been working to substitute products as well in order to minimize the impact. And as I said in my earlier comment, we anticipate having cycles being validated early in 2020. So, and we are working towards that.
Richard Newitter:
Okay, thanks. And, Liam, I appreciate that, the cadence of achieving the margin expansion over the long-range plan. It's more margin expansion in 2020 versus what we saw in 2019. And then more in 2021 versus what you'll see in 2020, but just if I could, maybe just kind of throw out what the consensus range for 2020 is it's between 100 to 200 basis points of margin expansion anticipated for next year and then something north of 200 implicitly baked in to get to your long range plan. I guess, could you just give directional color, is that an okay place to be for the street, do you feel comfortable generally as a framework for thinking about the cadence with where the current Street is? Thanks.
Liam Kelly:
Thanks, Rich. As you can probably appreciate, I can't comment on 2020 guidance at this stage. So, I think that as we look at it, I reiterate what I said. There will be a pickup in margin expansion in 2020 and there will be a further pick up on op margin. I would expect – let me try to help you here. I expect more op margin than gross margin expansion in 2020, maybe that would help you frame and in line with what you said, but it's hard for me to comment on 2020 and 2021 until I get to our Q4 and 2020 guidance, Rich, is I'm sure you're going to appreciate. But we're very confident in getting to 60% to 61% by 2021 and we're very confident on getting to 30% to 31% by 2021. I hope that will give you some flavor.
Thomas Powell:
And just to throw in a couple of factors that we've got out there happening in 2021, why they step up or why they hear steps up so much more than 2020. First is the conversion of the UroLift 2 we expect to complete by 2021, and that's going to drive actually a pretty significant amount of margin expansion. Then, also just on the cadence of our footprint projects, we will have meaningfully more savings in 2021 than we will in 2020. So those are two factors that serve to really drive that 2021 margin expansion, up more than the other years.
Richard Newitter:
Okay, thanks a lot.
Thomas Powell:
Obviously, the reduction in some of the investments that we put in this year helps 2020.
Liam Kelly:
Thanks, Rich.
Operator:
Thank you. Our next question comes from Shagun Singh with Wells Fargo. You may proceed with your question.
Shagun Singh:
Hey, guys. Thank you so much for taking the questions, and congratulations on a great quarter.
Liam Kelly:
Thank you, Shagun.
Shagun Singh:
Liam, the Street appears to be modeling about 50 to 150 bps contribution from MANTA, which is on top of the LRP, is that reasonable? Are you expecting pent-up demand, if you can give us your take on 2020? And then also year-to-date core is tracking to about 5.4% and UroLift – core ex-UroLift is tracking to 5.4% and then UroLift is tracking to about 3.5%. How should we think about these two buckets in 2020? And then I have a follow-up.
Liam Kelly:
Yes, so let me deal with the latter half of your point – your question first. So if you take the midpoint of our updated guidance, it is about 8.125%. Our expectation is that ex – that UroLift will add around 3% and the rest of the business will add around 8% – pardon, will add around 5%. So that will get us to that 8.125% at the midpoint of our range. To address your question with regards to MANTA, as I said in my prepared remarks, we continue to make excellent progress with the U.S. LMR in the quarter. We're getting very positive feedback and we've got a very high reorder rate from the testing sites. That to me is a real positive. We will continue with the LMR in Q3. And as I sit here today, I can tell you, we are pretty much finalized on our pricing strategy and we will go to full market release on January 1, 2020. With regard to its impact on the revenue in 2020, obviously expected to be positive, but again like my comments to many of your colleagues, unfortunately, I can't start to give guidance for 2020. I will do that when we announce our quarter four results and our guidance for the year, but I can tell you, Shagun that it's gone better than expectations and again it all comes back to patient outcomes and clinical data. This product has robust clinical data showing 70% reduction in major vascular complications and meantime to hemostasis going from 6 to 10 minutes, down to 23 seconds and the surety of closure is what we're discovering is really important to the sites that they know that they’ll close it first time, every time. So it's very positive. It's going well. And it will be a driver in 2020.
Shagun Singh:
Thank you so much for that color. And then just as a follow-up. I wanted to focus on UroLift in Japan where you are – you're waiting for reimbursement, how are you preparing for the launch in 2020 and how quickly are you able to commercialize once reimbursement becomes effective, which is likely on April 1? Thank you so much.
Liam Kelly:
So, yes, so we expect to reimbursement in the latter half of 2020 and we expect to be generating revenue in 2021. So you're absolutely correct there. What we are doing in preparation of that, and this was part of the investments that we pulled forward into 2019, we have got market development specialists on the ground, working with the key opinion leaders and urologists in order to ensure that they are aware of the product. And that they are assisting in communicating with the authorities that the need for this product is in the marketplace and that is an ongoing process, and will continue during 2020 until we get the reimbursement in the latter half of 2020 and generate revenue in 2021. And I would reiterate again Shagun that the revenue for UroLift was not initially in our LRP because we didn't anticipate having approval in Japan in 2021, which now we expect. So, we do expect revenue in 2021, which wasn't in our original plan.
Shagun Singh:
Thank you.
Liam Kelly:
Thank you very much.
Operator:
Thank you. Our next question comes from Matt Taylor with UBS. You may proceed with your question.
Matt Taylor:
Hi, thanks for taking the question. I was hoping you might give us some color on the UroLift patients if you have any view on whether the TAM is changing here? Are you still seeing mostly drug dropout patients be treated or is that actually expanding into other patients. And can you comment on the competitive environment, are you seeing other MIS treatments also pickup and what's happening with surgery? Maybe just comment on all of those dynamics.
Liam Kelly:
Yes. So the TAM, we don't believe has changed. We still believe that the U.S. market is a $6 billion market, if you take the drug dropout category. The best data we had was during the L.I.F.T. study which showed that almost 70% of our patients came from the drug dropout category. And anecdotally, we don't think that has changed at all, that's where the majority of our patients come from. With regard to do we see a drop off in surgical procedures? No, and I wouldn't expect too much because as we promote the UroLift product and as doctors move more and more patients into treatment for BPH with the UroLift product, they will also draw from patients that would traditionally have had a TURP or had a surgery. But also we're adding to that pool of patients because as they examine the patient, they may find that patient has got an ongoing disease of the bladder or they may have a prostate, in 5% of cases the prostate is too large for UroLift and those patients will be added to the surgical pool. So, as we draw off from the surgical pool, we are also adding to the surgical pool, so therefore we've never expected that TURPs would go down for example as UroLift goes up. The third part of your question, Matt, I think was on the competitive landscape, we haven't seen any new technologies come to the marketplace and the technology that we see out there are the traditional ones, a TURP more or less is done with steam rather than with just a different form of ablation. And we continue to focus on the patient outcomes, because we believe that a patient will opt for a procedure that they can go in on a Friday, have the procedure done, won't wear a catheter, no sexual dysfunction, immediate relief and you could be back sitting at your desk on Monday morning rather than an invasive surgical procedure that gives you a risk of sexual dysfunction, almost guarantees you are wearing a catheter and in some instances that catheter placement is for a period of time. And I still believe that the real world data on UroLift is so compelling compared to the real world data on any other technology out there because our real world data is showing better results than the clinical data, whereas with other technologies, we've seen worse results in the real world as compared to the clinical data.
Matt Taylor:
Thanks Liam. That's good color. I just had one follow-up, which is, looking probably a couple of years out at China, what do you think the reimbursement in the addressable market could look like there?
Liam Kelly:
So, as the Chinese market is a significant market from the population standpoint, we are currently working on sizing that and we'll be able to give some more details as we enter that market space. I do think that we have an advantage in China insofar as that we have a very robust call point in China into the urologist. And the reimbursement world in China – Chinese market, Matt, is a paper plate. So it's an out-of-pocket and always has been, not just for this procedure but for every procedure, it is an out-of-pocket experience for the person that has the procedure. We will – are building our dossier for the submission of registration of the product to the Chinese authorities and we would anticipate at this stage sometime late in 2021, we would be in a position to get reimbursement, if they don't require clinical study, if they do, that would push that into 2022, Matt.
Matt Taylor:
Okay, great. Thank you.
Operator:
Thank you. Our next question comes from Raj Denhoy with Jefferies. You may proceed with your question.
Anthony Petrone:
Hey, this is Anthony in for Raj. Congratulations on the quarter. I actually have a couple on MANTA, and then one just on the balance sheet and M&A. On MANTA, can you maybe just recap how you're looking at the market, there is trending now obviously, the TAVR market is proving to be more expensive with the low risk indication. And I think this year, we're looking at 90,000 procedures. The technology is also using EVARs. And so in the limited market release, how are you seeing MANTA being used in those two-end markets? How are you seeing pricing shake out versus the competitor? And then ultimately, what do you think your penetration can be in these two-end markets? And then I'll have a follow-up. Thanks.
Liam Kelly:
So what we're seeing in the limited, so first of all, let me size the market. We size the market as $200 million to $300 million that is before the expansion into lower TAVR procedures, that could probably add another $20 million or $30 million to our TAM potentially. What we're seeing in the limited market release is the majority of the procedures that it's being used in is in TAVR. We are focused on the TAVR centers and because it has, they are larger, they are faster growing and – but obviously that intervention is if it does the TAVR, it does the EVARs as well. So obviously, we're picking up EVAR procedures and even it's also being used with the Impella in a number of cases. From a pricing perspective, we have now got a much better understanding of the relationship between price and volume for the bigger centers versus the smaller centers. We have our pricing strategy pretty much complete in preparation for January 1 full launch of the product and we feel confident that we have pricing nailed down in order to ensure that pricing won't be a barrier to adoption based on volume. You'll have to excuse me, Anthony, if I don't go into details on the pricing, I'm sure our competitors listen to the call the same as anyone else. So, I don't want to share that from competitive reasons, but I can tell you, Anthony, that we feel incredibly confident in our pricing strategy. And we believe that it will not be a barrier to adoption. And even at the lower end of the pricing strategy that we have for a significant volume, it is up, still accretive to Teleflex and this product will be an accretive product to Teleflex gross margin and a driver for growth over the long-term.
Anthony Petrone:
Fair enough. And actually the follow-up will be, instead of M&A actually intra-aortic balloon pumps. So your competitor had a recall last quarter, it looks like the business over at Teleflex benefited from that. It seems that that was the case this quarter, so just an update on intra-aortic balloon pumps and how that dynamic is playing out? Thanks again and congratulations.
Liam Kelly:
Yes, thank you very much. So the intra-aortic balloon pump recall by the competitor, we won't see a benefit to that, Anthony, in all fairness, what customers will tend to do because it's capital equipment, they’ll postpone the purchase for a period of time. Our growth is purely down to taking share from that same competitor. Now, the longer the recall goes on, you would expect that in Q4, but still hangs out there, if you won't, we will get a benefit then. But our growth has been driven by us taking share from that competitor and our balloon pump business is growing in the very, very high teens rate in that area. So we're very confident in our business. I will tell you that we are taking share with new pump on the market, it's doing exceptionally well and we're very happy with that business. We will see – start to see the benefit, I believe of the recall, the longer it goes on and in particular as we get into this quarter we are in now and into the coming quarters.
Anthony Petrone:
Thanks again.
Liam Kelly:
Thanks, Anthony.
Operator:
Thank you. Our next question comes from Brian Weinstein with William Blair. You may proceed with your question.
Brian Weinstein:
Hey guys, thanks for taking the questions. The U.S. number or the Americas numbers was obviously very good. We have seen though in the past, sometimes you get hit by distribution patterns, where things get a little bit ramped up and then have to get pulled back in the channel. Question is are you seeing anything that suggests or maybe any overstocking somewhere we may need to think about that going forward. And, in particular, we're hearing about flu-related products at distribution seeing a bigger bump than usual heading into the season. So can you talk about any impact that you saw in any of that? Thanks.
Liam Kelly:
Absolutely, Brian, I think that we are looking at it. First of all, we saw a modest destocking by distributors within the third quarter. So, and that's in line with our expectation, you normally expect to see that, but more encouraging for me, in the key North American market is the revenue I recognize is the revenue I sell into the distributor. But if I look at my tracings and if I look at the end customer demand, my end customer demand is actually greater than what I'm selling in and recognizing through the distributors. So that gives me a certain level of confidence that there is not an issue with regard to the stocking that I should be worried about, in particular, since I've seen modest destocking in the third quarter. Having said that it's, I don't have the best visibility into it, but I think the portfolio we've built, Brian, is one that has protected us against this. In the past, half of our business would have gone through these box-moving distributors, whereas now only a third of our business and the happiest moment for me, I have got to tell you was when we had some destocking in Q1 and restocking in Q2 and the investment community hardly even noticed it. And that's the type of portfolio we're trying to build in Teleflex, and that's the level of execution that we're trying to deliver in Teleflex and I have got to say the other bit that has happened is that I feel is that this is the fifth quarter back to back that we have been absolutely consistent in our delivery on almost every line on our income statement; revenue, margins and earnings. So the level of performance by our teams out there is at a very high level.
Brian Weinstein:
Great, thanks for taking the question guys.
Liam Kelly:
Sure, Brian.
Operator:
Thank you. Our next question comes from Matthew O'Brien with Piper Jaffray. You may proceed with your question.
Adam Maeder:
Hi, it's Adam on for Matt, congrats on the quarter and thanks for taking the questions.
Liam Kelly:
Thank you.
Adam Maeder:
I wanted to ask about capital allocation over the next 12 months for the company or so just including the potential for M&A, are you seeing attractive assets or multiples still to speak at this point? And I had a follow-up.
Liam Kelly:
Okay, Adam. So, first of all, let me start with our leverage. Our leverage is about 2.45x at the end of this quarter. So we definitely have capacity. Multiples have not been the issue for us in the assets we look at, the assets that we have traditionally focused on were always high quality assets. The multiple expansion, at least what I'm seeing out there, has come in lower quality assets, which were never the assets that Teleflex had been interested in. Our preferred use of capital is to continue to do M&A and we are very active in the marketplace looking at assets. I guess, the easiest way to tell you, I'm spending more of my time on M&A in the last number of months than I have in any time since I took over as CEO. We continue to see attractive assets in the space that we look and I think what gives us an advantage in this area is that we're looking pretty broadly. So, we're looking in men's health, we're looking in vascular area, vascular area, we're looking in the surgical area, we're looking in the OEM area. We're looking in the Anesthesia and Emergency Medicine area, and of course we never stop looking in the Interventional, Cardiology, and Radiology area. So we're looking at a broad spectrum and the assets that we look at, we think we'd be able to carve out value even in the current environment, but rest assured we are active and busy.
Adam Maeder:
That's very clear. Thanks. And then if I can squeeze one more in on the surgical side. Can you update us on the rollout of Percuvance, I know that's been in a limited launch space, can you just talk about the clinical feedback from clinicians and when we should expect that to progress to a more full launch? Thanks for taking the questions.
Liam Kelly:
Yes, thanks, Adam. So we're continuing with the limited market launch. As I said a couple of times, Percuvance is really a show me product. We want to finish the limited launch. We have some clinical work that we want to finish as well before we get too excited about the product, but rest assured, once we get to 2020 guidance, we'll give a further update.
Adam Maeder:
Appreciate it. Thank you.
Liam Kelly:
Thank you.
Operator:
Thank you. Our next question comes from Dave Turkaly with JMP Securities. You may proceed with your question.
Dave Turkaly:
Hey, great, thanks. You may have mentioned this, I apologize if you did, but that sterilization plant, when exactly did that occur and what was the cause of it going offline or closing?
Liam Kelly:
Yes. So Dave, this has been pretty well documented within the media. The initial concerns were in relation to ETO emissions in the Atlanta area. Then it became, I believe, an issue for the local Cobb County with regard to permits. The company is working with the local Cobb County, the environmental group, the last I saw had put out a notice that the company was compliant to all the relative standards and they are working now with Cobb County trying to reopen the facility. As I said earlier, they don't have any line of sight as to when they will be able to reopen the facility, but we have transitioned products to other qualified sterilization cycles to minimize the impact down to that $8.7 million in revenue and $0.07 in EPS.
Dave Turkaly:
Got it, thanks. And then the last one, just quickly the $130 million tax benefit, is that or you said something about O-U.S., I think restructuring, but is that, I'm sure it's a one-time, but are there other opportunities for things like that, is that just sort of something we shouldn’t expect to see again?
Liam Kelly:
That is a one-time benefit that will occur this quarter, in this quarter only. I wouldn't count on that in the future. There may be some other restructurings out there that could bring on a similar benefit. However, I wouldn't count on that. There is no line of sight right now currently doing anything else along those lines.
Dave Turkaly:
Great, thanks.
Operator:
Thank you. Our next question comes from Mike Matson with Needham & Company. You may proceed with your question.
Mike Matson:
Yes, thanks. So just back to the sterilization issue, I understand you're trying to address the problems with the current products that are exposed. But just from a risk mitigation perspective, is there anything you could do with other products and other facilities to try to prevent this type of impact in the future or is that just not possible?
Liam Kelly:
Good question, Mike, one thing that we have done is we have looked at comparable cycles, validated additional cycles in a risk mitigation stance. And also we have on our major codes, as Tom mentioned in his discussion around our increase in inventory, part of the tactical increase in inventory is around risk mitigation against any other sterilization issues. I think, Mike, it really comes back to the fact that there are 20 billion medical devices that are sterilized in the United States using ETO. And it is a requirement because other types of sterilization processes do not work on products with deep crevices, products made of certain materials. So, I think we've got to have a balanced approach here. Obviously, we all want to protect the environment, we all want to have a safe environment to live in, but if you're living in LA, you have as much exposure because of pollution than you would in any other area. So, I think, common sense is starting to prevail. It is my observation and I was particularly encouraged by the FDA statement that they made last week.
Mike Matson:
Okay, thanks. And then just one follow-up, just on MANTA, is there any economic data as part of the SAFE MANTA trial or any other trials or is anything – efforts underway to collect any economic data that could help drive adoption and maybe get this thing through VAC committees? Thanks.
Liam Kelly:
Yes, there is a JAMA study that was published that I believe stated that a major complication would cost a hospital $18,000 to treat. That study was done in 2017. And the clinical data for the product is compelling in this area where it shows over 70% reduction in those major complications from 7.5% to 2%. So, if you combine that with the JAMA study, Mike, that that would be a compelling argument for any VAC committee.
Mike Matson:
Thank you.
Operator:
Thank you. Our next question comes from Matthew Mishan with KeyBanc. You may proceed with your question.
Matthew Mishan:
Great. And thank you for squeezing me in, I just have one. Can you guys update your free cash flow expectations for the year? And I'm sure there are some annual increases throughout the LRP. But I think free cash flow was supposed to be somewhere between $500 million and $550 million per year through that LRP and there seems to be a delta between where you are today and those expectations? Can you kind of bridge those?
Thomas Powell:
Sure. So to your point when we put together the LRP and guided at Analyst Day, we had said that free cash flow would average between $500 million and $550 million over the period 2019 to 2021 and inherent in that guidance was the assumption that free cash flow would in fact build to your point. So in 2019, we thought it would be less than that three-year average, 2020 kind of in line, and 2021 well in excess. Now since putting the LRP together, we've experienced improving results from the NeoTract business and we've made other business decisions aimed at improving our operations and some of these decisions will have an impact on the near-term free cash flow. So for 2019, I'd now expect cash flow from operations around $435 million and CapEx of approximately $100 million. Now let me give you some kind of the key deltas from when we put the LRP out there, why we're not seeing free cash flow at the same level that we initially expected. The first is that NeoTract is performing better and as a result, we are paying a higher level of contingent consideration than what was originally contemplated in purchase accounting and those additional payments in excess of what was initially booked actually go through cash flow from operations. Then, in addition, we put in an additional restructuring program in 2019. And that program doesn't generate savings until 2021 and there's also cash outflows that we have to invest in the project in 2019. And there's also CapEx associated with it. And then in another action that we've taken in an effort to really enhance customer service, we have reevaluated our safety stock levels and as a result we've increased our strategic inventory balances this year. Now we believe that this is part of the reason why we're seeing improved customer service results including improved on-time delivery. And we think will ultimately benefit the company over the longer term, but each of these have served to reduce the free cash flow from our previous expectations, but again we're pretty happy that NeoTract is over-performing. We think the increased inventory will actually help the business as well as the restructuring programs will help us in the longer term.
Matthew Mishan:
And just a follow-up to that Tom, is the contingent – changes in contingent consideration, is that a one-time payment that's impacting 2019 or is that something else that would potentially impact 2020 and 2021 as well?
Thomas Powell:
It could potentially impact 2021 – 2020.
Liam Kelly:
2020. So the bulk of the contingent consideration runs through to the end of 2020 and it is paid in 2021 for NeoTract.
Matthew Mishan:
All right, thank you guys.
Liam Kelly:
Thank you.
Operator:
Thank you. Our next question comes from Kristen Stewart with Barclays. You may proceed with your question.
Kristen Stewart:
Hey guys, congrats on a great quarter and Happy Halloween.
Thomas Powell:
Thanks, Kristen.
Liam Kelly:
Thank you, Kristen.
Kristen Stewart:
Just a couple of follow-ups for me. Just wanted to circle back on, I guess, David's first question. He had mentioned RePlas, which I guess now is called EZPlas as being something to expect in 2020. I just want to make sure I didn't miss something on that. Is there an update on that product as my understanding was that that was still something that you're trying to figure out the filing timeline on that, could you provide an update on that? And then I have a follow-up as well.
Liam Kelly:
Yes, absolutely. I think David asked about MANTA but happy to discuss EZPlas. As we said on our last call, we would give an update once we had a clear line of sight to BLA submission. But I can tell you that our collaboration with the FDA continues to be very constructive and obviously the FDA, Teleflex, and the military, we're all excited about the product as we know it can have a positive impact on humanity. As we continue this journey, we have done a significant amount of testing and we submitted that to the FDA. We have ongoing testing that we are doing that we will continue for the next few months. Again, working with the FDA, we have agreed the pediatric study plan, which was a big step forward. And I think that for us is a positive development. So we've covered that obstacle and of course, we are sailing unchartered waters with the FDA, but we are working hand and glove with them, making progress, and as soon as we have a clear line of sight to the testing being done, submitted to the FDA, and a clear timeline for the BLA, we will update the investment community. I would just remind you that we had about $7 million for this product in our LRP by 2021. And we believe that it is $100 million market opportunity, $25 million in the military and $75 million in the civilian market. So continue to work on it and making progress.
Kristen Stewart:
Perfect. So, then the other question I have is just on UroLift manufacturing. I believe you guys produce that in Pleasanton, is that at all impacted by some of the rolling kind of blackouts with what's going on with the fires in California or any level of risk there, I am not sure if you guys have any alternative manufacturing in Mexico or anything, just anything to think about there. I'm sure you guys have safety stock and everything else, probably generators too, but just wondering how you guys are thinking about that as a risk level?
Liam Kelly:
We have a hamster on wheel, Kristen…
Kristen Stewart:
That's good to hear.
Liam Kelly:
We are actually, we…
Kristen Stewart:
Perfect, thank you.
Liam Kelly:
We're in good shape there. When we bought the NeoTract company, we identified this as a risk. And in the first 12 months, we opened up an alternative manufacturing site in one of our existing facilities, so we can manufacture this product in dual sites and we haven't had any impact of the power outs that I'm aware of. So, no impact of the power outs and dual manufacturing already established as a company.
Kristen Stewart:
Perfect. Those hamsters are doing well then. Glad to hear.
Liam Kelly:
They're going around in circles.
Kristen Stewart:
All right. I feel like that too, so. All right, thanks very much guys. Congrats again on the quarter.
Liam Kelly:
Thank you.
Operator:
Thank you. I'm not showing any further questions at this time, I would now like to turn the call back over to Jake Elguicze for any further remarks.
Jake Elguicze:
Thanks, operator and thanks everyone for joining us on the call today. This concludes the Teleflex Incorporated third quarter 2019 earnings conference call.
Operator:
Thank you. Ladies and gentlemen, this concludes today’s conference call. Thank you for participating. You may now disconnect.
Operator:
Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Teleflex Incorporated Second Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode to prevent background noise. [Operator Instructions] Now it's my pleasure to turn the call to Jake Elguicze, Treasurer and Vice President of Investor Relations.
Jake Elguicze:
Good morning everyone and welcome to the Teleflex Incorporated Second Quarter 2019 Earnings Conference Call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing 855-859-2056 or for international calls 404-537-3406, passcode 8346258. Participating on today's call are Liam Kelly, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks, and then we'll open up the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. With that said, I'd like to now turn the call over to Liam.
Liam Kelly:
Thank you, Jake, and good morning everyone. It's a pleasure to speak with you again. The second quarter of 2019 was very positive for Teleflex as we accelerated the momentum in our global business, delivering 7% revenue growth on an as reported basis and 9.6% on a constant currency basis. When normalizing for the impact of one less shipping day, second quarter constant currency revenue growth was 10.8%. Like the first quarter of the year, during quarter two, the strength in our top-line line performance was once again broad-based driven by improvements across nearly every global product category. This included 42.7% growth in Interventional Urology, 12% percent growth in Vascular Access, 9% growth in Surgical, and 8.8% growth in Interventional Access. But from a geographic perspective, we achieved particularly strong growth within the Americas and Asia where constant currency revenue growth was 13.1% and 10% respectively. Turning to some other key metrics; we reported adjusted gross margin of 57.7%, adjusted operating margin of 25.2%, and adjusted earnings per share of $2.66, which represents an increase of 7.7% over the second quarter of 2018. Our adjusted earnings per share performance in quarter two was slightly better than we expected in our last earnings call despite a greater than expected headwind from FX. If we were to normalize for the year-over-year currency headwind, our adjusted earnings per share would have grown 13.8% during quarter two. In summary, we are incredibly pleased with our better than expected revenue performance in the second quarter and first half of the year. This has been added to increase our full year 2019 guidance for constant currency revenue growth from a range of between 6% and 7% to a range of between 7.5% and 8%. Additionally, based on strong UroLift performance during the first half of the year, we are increasing our full year UroLift revenue growth guidance from a growth rate of approximately 30% to a growth rate of approximately 35%. We are pleased that our increased 2019 revenue growth expectations are being driven by a combination of both, UroLift and non-UroLift product; and if you were to break down the components of our full year constant currency revenue guidance raise on a dollar basis, approximately one-third of the raise is driven by UroLift while approximately two-thirds is driven by the remainder of our products. Moving away from revenue; today we are also reaffirming our full year 2019 adjusted gross margin guidance, but we are slightly lowering our full year adjusted operating margin guidance largely due to increased headwinds from FX and decisions we made to make certain growth and infrastructure investment. Yet, due to a combination of strong revenue performance coupled with reduced expectations for interest expense, we can offset significantly worse impact from FX and we are reaffirming our adjusted earnings per share guidance range of $10.90 to $11.10. We are pleased with our expectation to grow full year 2019 adjusted earnings by 10% to 12% while funding investment behind key revenue growth opportunities and offsetting headwinds from foreign exchange and tariffs. With that as an overview, let's now at quarter two revenue in more detail. I will begin with a review of our reportable segment revenue and unless otherwise noted, the growth rates I would refer to are on a constant currency basis. The Americas delivered revenues of $373.8 million, which is an increase of 13.1%. This was driven by our Interventional Urology and Vascular Access product category. Moving to EMEA; in reported revenues of $147.1 million, which represents an increase of 1.9%, during the quarter the growth was led by our Interventional Access and Vascular Access products. However, the performance of this region was slightly lower than what we anticipated a few months ago due to the timing of certain orders. As we look forward, we expect EMEA performance to improve in the second half of the year as compared to the performance during the second quarter. Turning to Asia; revenues totaled $75.2 million, which is an increase of 10% as compared to the prior year period. From a product standpoint, growth was strongest within our surgical and Vascular Access categories, while from a geographic perspective, our business in China grew 15% and we also saw strength in Korea and Southeast Asia. And lastly, our OEM business reported revenues of $56.4 million which represents an increase of 8.5%. Growth here was led by strength in our suture and catheter product offering. On a full year basis, we continue to expect this business to grow in the upper single-digit range. However, due to a difficult comparable, as well as the timing of certain orders we expect growth within this segment to be relatively flat as compared to the prior year period during the third quarter. Now let me move to a discussion of our revenues by global product category. Like my comments regarding our reportable segments, my comments regarding our global product category growth will also be on a constant currency basis unless otherwise noted. Starting with Vascular Access; second quarter revenues increased 12% to $153.6 million. This was driven by strong growth and CVCs, PICCs and EZ-IO. Additionally, we saw an increase in distributor orders during quarter two that positively impacted results. This was essentially the reverse of the distributor destocking that negatively impacted our quarter one Vascular results. Moving to Interventional Access; second quarter revenue was $104.8 million, which is an increase of approximately 8.8%. The strength of this business during quarter two was broad-based with growth in complex catheters, biologics on-control and intra-aortic balloon products. And while not a meaningful driver of Q2 growth, let me provide you with a brief update on MANTA, our large bore closure products. The first three months of MANTA's limited market release have gone very well as the product has received strong positive feedback from key both leading positions as we continue to conduct price discovery in the market. We have made good progress on our strategy to generate positive clinical outcomes at key institutions, and we remain on-track with our strategy of generating additional positive physician and patient experiences as we move through the remainder of 2019. We continue to believe that MANTA will contribute to our top line in a more meaningful way in 2020. Turning to Anesthesia; second quarter revenue was $85.7 million, which is a decrease of 0.9%. The decrease here is primarily driven by softness in airway and pain management products. Turning to a brief update on RePlas which going forward will be referred to by it's new commercial name EasyPlas. As a reminder, we are on a fast-track approval process with the FDA and our most recent public comments regarding this product indicated that we expected to complete our BLA submission by the third quarter of 2019. In the course of our frequent communications with the FDA, which have been highly collaborative, we recently received additional questions from the FDA. Although we previously anticipated many of these, there were others that will require additional analysis and testing, which would take more time to complete; therefore we no longer expect to complete the BLA submission by the third quarter of this year. While this is unfortunate, we view this as a temporary setback. The fact that the BLA submission will take additional time to complete is in part due to the unique nature of the product as a biologic product like this has never been approved by the FDA before. It is important to understand there was no revenue assumed in our 2019 financial guidance related to this product, and less than $10 million in revenue by 2021 in the long-range plan estimate we shared at our Investor Day last year. As we move forward to continue to work with the FDA, we will continue to provide updates as part of our quarterly earnings call as and when we receive further information on the BLA submission and he associated regulatory timing of EasyPlas. Shifting to our Surgical business; revenue increased 9% to $95.6 million driven by sales of ligation clips and surgical instruments. While this business fundamentally performed very well in quarter two, many of you will recall that it was also against an easy year-over-year comparison. Moving to Interventional Urology, revenue increased 42.7% to $67.9 million, our sales force continues to make excellent progress driving physician adoption of the UroLift system, and we expect to train a total of 450 new urologists during 2019. From a patient demand perspective, our direct-to-consumer program is performing well, and it is driving new patients toward talking to their urologists about whether they are a good candidate for UroLift as a solution to their BPH. Transitioning to UL2; we continue to expect to begin the rollout of UL2 in the latter half of this year with a full conversion of the UL's physician base from UL1 to UL2 expected in 2021. We are also continuing to actively see the market for the launch of UroLift in Japan, and we remain on-track for a limited market release in mid-to-late 2020 with revenues ramping more meaningfully in Japan during 2021. Given the outperformance of UroLift in the first half of the year, we are raising our annual 2019 Interventional Urology revenue growth from approximately 30% to approximately 35%. And finally, since OEM was covered in our segment review, let me summarize second quarter revenue for the businesses within our other category which consists of our respiratory and urology care products. Revenues were up 0.3% in the constant currency basis, totaling $88.4 million; this was driven by an increase in sales of our bladder management products, offset by declines in sales of our respiratory products. That completes my comments on quarter two revenue performance. Next, I would like to briefly discuss some important clinical and reimbursement update on UroLift. First, we are pleased to announce that Anthem, one of the nation's leading health insurance providers has revised their surgical and minimally invasive BPH medical policy to revise coverage for UroLift. With the announcement of Anthem coverage, UroLift has now achieved coverage by all the national and regional commercial plans, and all independent licensees of the Blue Cross Blue Shield Association, as well at 100% Medicare coverage. Given that Anthem with the last large commercial payer to change their coverage policy on UroLift to positive, our reimbursement teams' focus is now on supporting this strong coverage with robust clinical and real world data, and that with any new commercial payer coverage decision Anthem will take time to work through the commercial channel. Therefore, we do not expect any material upside to our 2019 UroLift guidance due to this coverage decision. Let me move briefly to a clinical data update. A meaningful part of our strategy to make UroLift the standard-of-care to treat BPH is to create an industry-leading high-quality set of published clinical evidence. On our last earnings call, we announced our 1,413 patient's real-world study, and that results were consistent with those seen in previous clinical studies of the UroLift system, even with a more diverse patient population. In July, the study was published in the Journal of Endourology, its publication serves the tool for our sales team to use when calling on both, new and existing physicians. In closing, I would like to reiterate how pleased we are with our second quarter and first half of the year performance. Revenue growth has been incredibly strong, driven by a broad spectrum of products and geographies which led us to increase our revenue guidance for the full year. We have been working to build a product portfolio capable of accelerating revenue growth and gross margin expansion and feel we are on-track to achieve that goal. When you take a step back and look at the midpoint of our increased full year 2019 constant currency revenue growth guidance range, approximately 2.8% of our expected growth is driven by UroLift and nearly 5% is being driven by the remainder of our products. In fact, the midpoint of our increased constant currency revenue growth guidance range indicates that we expect to grow approximately 7% during the second half of 2019, and this is against more difficult comparison. The ability for us to accomplish this gives us additional confidence in our ability to consistently grow between 6% and 7% over a multi-year period. In addition to continued revenue growth in the second half of the year, we also expect to generate a material improvement in our adjusted gross and operating margins which will translate into meaningful earnings and free cash flow generation. And as such, we are reaffirming our full year adjusted earnings per share guidance range. That completes my prepared remarks. I would now like to turn the call over to Tom for a more detailed review on our second quarter financial results and full year 2019 financial guidance. Tom?
Thomas Powell:
Thanks, Liam and good morning, everyone. Given the previous discussion of the Company's revenue performance I'll begin at the gross profit line. For the quarter, adjusted gross profit was $376.6 million versus $348.3 million in the prior year quarter, or an increase of approximately 8.1%. Adjusted gross margin increased 60 basis points to 57.7%, the expansion in adjusted gross margin primarily reflects increased sales volumes, benefits from cost improvement programs, and a favorable sales mix of higher margin products. Partially offsetting these gains were negative impact from foreign exchange, incremental tariffs, higher logistics and distribution costs and inflation. Adjusted operating profit was $164.7 million as compared to 158.8 million in the prior year. Adjusted operating margin in the second quarter of 2019 was 25.2% which is a decrease of 80 basis points over the prior year period. As the improvement in gross margin was offset by the negative impact from foreign exchange, additional selling expenses related to the revenue upside and select investments designed to upgrade our quality systems, strength and protection of our IP portfolio enhanced customer experiences while interacting with Teleflex. On a currency neutral basis, adjusted operating margin would have been approximately flat to a year ago period. Continuing down the income statement; net interest expense decreased to $20.3 million from $26.5 million in the prior year quarter. The decrease primarily reflects the impact of our cross-currency swap agreements. Moving to taxes; for the second quarter our adjusted tax rate was 13.4% versus 12.7% in the prior year period. The increase in our adjusted tax rate is primarily due to the mix of earnings in higher tax jurisdictions, as well as a reduced amount of windfall benefit from stock-based compensation. Adjusted earnings per share was $2.66 or an increase of 7.7% as compared to the prior year. We are encouraged by the strength of our earnings performance as this result includes a foreign currency headwind of $0.15. So on a currency neutral basis, adjusted earnings per share increased by approximately 13.8% in the second quarter. In addition to the FX headwind, second quarter earnings also included incremental year-over-year tariff expense which reduced earnings by approximately $0.03, as well as a headwind from the divestiture of our catheter reprocessing business which contributed $0.01 in the prior year quarter. Turning now to select balance sheet and cash flow highlights. During the first six months of 2019, cash flow from operations totaled $157.3 million compared to $181.6 million in the prior year period. The decrease in cash flow is primarily attributable to contingent consideration payments. Finally, during the second quarter we further reduced our outstanding debt by approximately $28 million and our net leverage stood at approximately 2.63 times. This completes my comments on our second quarter results. Now I'll move to 2019 guidance updates. Given our performance for the first six months of the year and our expectation for the remainder of the year, we are increasing our full year constant currency revenue growth guidance from a range of between 6% and 7% to a revised range of between 7.5% and 8%. We are also increasing our as-reported revenue growth guidance from a range of between 5% and 6% to a revised range of between 6% and 6.5%. Our current expectation is that currency is 150 basis point headwind to revenue. Continuing down the P&L we are reaffirming our previously provided GAAP and adjusted gross margin guidance ranges. However, we are lowering our GAAP and adjusted operating margin guidance ranges. Our updated adjusted operating margin guidance range is reduced by 50 basis points from a range of between 26.5% to 27% to a revised range of between 26% and 26.5%. Similar to the second quarter discussion, reduction in full year adjusted operating margin expectations can be attributed to a couple of items. First, a less favorable FX environment versus our previous expectation. We project that 2019 operating margin will be adversely impacted by an additional 25 basis points versus our previous expectation. Second, additional selling expense associated with the revenue outperformance in UroLift and other areas of the business. And then third, proactive investments designed to both protect and enhance future growth prospects, investments include upgrades to our quality systems, strength and protection of our IP portfolio, enhanced customer experiences while interacting with Teleflex. Moving now to interest expense; on our last earnings call we pointed to the investment community to the low end of our $87 million to $90 million range. However, to date LIBOR rates have trended favorable versus expectation and we have now included a 25 basis point reduction for 2019. As a result, we are lowering our full year interest expense guidance to a range of between $82 million and $83 million. Turning to taxes; we are reaffirming our previously provided range of between 14% and 14.8% although, we now expect that will be at the very low end of that range. Over share count perspective, we now expect full year weighted average shares to be closer to 47.1 million as compared to our prior expectation of 47.2 million. And that takes me to our GAAP and adjusted earnings per share ranges; on a GAAP basis, we are increasing our full year guidance from a range of between $6.72 to $6.84 to a new range of between $6.82 and $6.94. On an adjusted basis we are reaffirming our previously provided guidance range which calls for earnings of between $10.90 and $11.10. Implicit in this adjusted EPS guidance range is our current FX assumption of a 35% full year headwind versus our previous expectation of $0.20. So given the strength of the revenue outperformance, we were able to maintain earnings guidance despite a $0.15 increase in the headwind from FOREIGN EXCHANGE. In closing, we are very pleased with the top line growth achieved in the first half, the acceleration growth was broad-based across our portfolio of products, we believe the investments made to-date are paying dividends and those planned for the balance of 2019 will serve to further strengthen our business platform and provides a framework for continued topline acceleration. While foreign exchange has somewhat tempered earnings growth, the underlying constant currency operating performance has been strong. Adjusting for currency; first half adjusted EPS grew by 13% and further adjusting toward the China tariff, first half adjusted EPS grew by 14.7%, so a very solid start to 2019. And that concludes my prepared remarks. I'd like to now turn the call back to the operator for Q&A.
Operator:
[Operator Instructions] And our first question is from David Lewis with Morgan Stanley.
David Lewis:
Liam, there's a lot of things to focus on here, obviously, NeoTract. But I wanted to focus more on what we used to call the core business. Two specific businesses, Liam, Surgical and Vascular took big steps forward this quarter. And I wonder if you can just sort of talk about the momentum you're seeing in those businesses and outlook for the back half the year? And then I had a follow-up for Tom.
Liam Kelly:
Thanks, David. And we're very pleased with the quarter. What we saw in vascular was really in the first quarter, as I outlined in our calls. We saw something stopping by distributors. And then in the second quarter, we saw that restocking as we had anticipated. So if you look at a nonday's adjusted Vascular Access growth through the first half of the year, Vascular Access grew by 7.2% to the first half the year. Now we expect Vascular as we said to be in the mid-single range, maybe not quite in the 7.2% range in the back half of the runs into a topper comp in the back half of the year. If you recall back to last year, actually Vascular in Q3 grew by about 7% and in Q4 grew by about 6%. So they're bottomed up against slightly tougher comps. But notwithstanding that the growth in Vascular is really, really positive for us. And it's coming from areas that we wanted to come from, PICC as we continue to take share and EZ-IO Vidacare had really strong second quarter. Second question on surgical, surgical had a really good second quarter growing at 9%. They have a, again it's a cost comparison, David. They had a weaker comp comparison to last year. If you recall the last year, they declined by about 3%. So that helps them but notwithstanding that, now that we've anniversary, the exit of that trocar business, we're seeing the Surgical business really perform very well and very much in line with expectations. And on a full year basis again, we expect the Surgical business to be in that mid-single growth rate for us.
David Lewis:
And then Tom, FX headwinds for sort of well understood into the quarter and we previous much. But can you just walk us through the implied guidance in the back half of the year, basically with the new updated guidance down 50 bps, we need to see kind of 3.5 points of margin expansion into the back half of the year. Can you sort of walk us through what gives you the visibility and confidence that you can deliver that number. Thanks so much.
Thomas Powell:
Okay. Well, certainly a fair question. And, to your point, FX was understood. We did have a larger-than-expected FX impact in the second quarter do some balance sheet evaluation. But let me just talk about full year. So in the first quarter of the year, the second quarter, we saw an increase in operating margins about 150 basis points. And as we move towards the back half of the year, we anticipate further sequential operating margin expansion, approximately 60% of our anticipated opening margin expansion in the second half is expected to be driven by higher gross margins. And 40% of the operating margin expansion is expected to deliver better operating expense leverage down the OpEx lines. The gross margin expansion from the first to the second half is expected to be generated by a combination of many factors and cost improvements, further benefits from various restructuring programs, as well as benefits from product and geographic mix. And while we expect to see a modest increase in the total operating expense dollars, the second half of the year, compared to the first half, we also anticipate an increase in second half revenue that results in improved leverage of our overhead cost structure. I think at the midpoint, we're about $70 million more revenue in the second half, and then tried some good leverage. This coupled with the fact that we incurred certain operating expenses in the first half of year. And we don't expect to reoccur in the back half of the year, such as trade shows investments made to enhance customer experience as well as some costs to strengthen our key portfolio do lead to reduce operating expenses in the back half. Traditionally, we've seen much better profitability in the second half verses first half given some of the upfront stream that goes on in the first quarter. So we recognized, there's some work to be done on the op margin, but we understand the drivers that need to take place, and the organization is focused to deliver on that.
Operator:
Thank you. Our next question comes from Larry Keusch with Raymond James.
Larry Keusch:
Good morning, everyone. I guess, Liam, I'm left with just some broad thoughts on M&A and clearly you're leveraging 2.6 times leverage gives you a position to driving transact deals. I'm really just very curious as to kind of how you're seeing the environment out there, asset valuations? Can you actually drive returns given the current valuation environment out there?
Liam Kelly:
Yes, Larry, you're absolutely correct in your assessment, we're at 2.6 times leverage. We have the capacity to do scale transaction should we find this. I think Teleflex is in a pretty unique position, Larry, insofar as we have capacity but no urgency. If we find the right asset, we, for sure, will be in a position to pull the trigger and get the deal done. And obviously, we're very financially disciplined and always have been, and we will be in the future. We will only do transactions that will give benefit to our shareholders. The environment is a little frothy out there, you're correct. But in fairness, Larry it's always been frothy with the good-quality assets. It's gotten a little frothy with a poor quality assets have been my observation but they're never the assets that Teleflex have been interested in any way. So have capacity but no urgency, Larry as how I position that. But we never, ever, ever stop looking, and we are active in the marketplace.
Larry Keusch:
Okay, that's perfect. And then I just want to pivot over to your lift in Japan specifically, obviously, that's as you look at the multiyear, multi-geography growth engine with that product that going to be an important market for you. I guess sort of two questions embedded here; Number one, you know, your comments were that, you expect to get this thing going midyear to the latter half of 2020. Just want to get a sense that it is best, flipping a little bit along that lines, could you sort of help us just think about as you have discussions with urologists over there, are there any dynamics in that market that would make be differently than the U.S.? I am just trying to gauge how quickly this market may start to gain traction?
Liam Kelly:
Yes, Larry. So first of all, there is no change to us and we always thought it will be in the latter half of 2020 that we would get the reimbursement through those and that we would start generating revenue by 2021. So, nothing changed in our thinking with regard to Japan. In the same way we classify the U.S. as $1 billion market. The Japanese market is $2 billion market. So you are correct in your statement that's a significant opportunity. Now I'd remind investment made in our regional team, we have not anticipated any revenue for Japan in 2021 which is the last year of LRP. So, we see this as a potential for upside. Regarding the dynamics of the market, Larry, we don't see a significant different in the dynamics of the market between Japan and U.S. at this stage. We do see a very collateral relationship with the Japanese Urology Association and the U.S. Urology Association. And we have met with many Japanese urologists at the American Urology Association Meeting every year and we continue to build relationships with those urologists. And also, I would also remind you now to forget, the urologist know us very well in Japan from using the kit. So we already have a relationship with them in the same ways we had in the United States. This is an area and a call point that tell us like knows very well and its a call point that we would really be interested in growing further. Back to your original question on M&A, we'll something in the MANTA's space that will be an interest for us.
Larry Keusch:
Okay. Terrific. Thanks Liam.
Liam Kelly:
Thanks.
Operator:
Thank you. Our next question comes from Richard with SVB Leerink.
Richard with:
Hi, thanks for taking the questions. One bigger picture, one on growth and then one on your U.S., Liam, just starting on the investments that you're making, you're pulling forward a little bit of the investment spend in the first half. So, I'm just curious if you could remind us where that be the incremental spend is going and what's the timelines are for the payoff there and within the contact of entering that your trending top line meaningfully higher, double-digit territory at selling days, I guess as we can get this one part a long range plan and the kind of pull forward spend, should we be thinking of you guys mat be a little bit towards a high single-digit at the upper end of your long range 6% to 7% over the part of your plan. Is that a fair assumption with kind of spending and what the payoff timeline like be there?
Liam Kelly:
So, first of all, I'd say, we are currently happy with the first six months of our LRP and it is first six months of our LRP. So clearly, the strategy is working. You know, our five to drive are older ones that are delivering through the first half of the year
Richard with:
And just on Europe, I think you said 1400 plant training in 2019. Can you just describe the Doctors and the characteristics of the types of doctors that you are training now versus six months ago and what you are seeing in potentially size of moving more to the mass adoption or passed early adaptor phase, if anything? Thank you.
Liam Kelly:
Yes, so, just to clarify Rich, what we said was we would train over 450 docs in this year in 2019, as the second quarter we had said that we had trained over so far of the 12,000 that are available. And what we had seen is that urologist in any spectrum can become a champion. So, this is very encouraging because I think end of the first quarter we frame one six of the doc and we were generating global revenues over $60 million. And I think that moving from the early adaptors to the path follow, we have all those been and continued to be cautious under ramp as you are getting that approved because it is more of a clinical scenario through the path followed. Now, I will say that what is incredibly encouraging to me and the management is the real world data that we have to support that fast follower adoption and the real world data has compared the LIFT study. There are some real key points here, IPSS scores in real-world after 24 months is a 9 point reduction compared to the LIFT. Quality of life still in the 40% as compared to the LIFT, catheter rates, 99.5% of patients were catheter free at the completion of the study versus 32% in the list which is a significant improvement. And of course retention rate 87% of main that were catheter free with the UroLift and this I think Rich what point that is a path and allowed us to bring in this daily adopter but none of the technologies and fail real world data is comparable to the clinical study they have probably to bring the product to market.
Operator:
Thank you. And our next question comes from Shagun Singh with Wells Fargo.
Shagun Singh:
Liam, I wanted to touch on core growth, you've delivered pretty strong results in the first half despite the one less selling days. But historically, the core, the range for the core growth has been pretty wide. So, how should we think about growth in your core portfolio relative to about, I guess, about 5%, or so that you deliver in the first half? And then I have a follow-up.
Liam Kelly:
Thank you. That was the point I was trying to make it in my prepared remarks. If you look at our full year increase guidance range, first of all, two-thirds of the growth is coming from ex-UroLift, I can put it that way. And then if you look at our complete growth for the years, we take the midpoint of our growth, which will be around 7.8%, 2.8% of that growth is coming from UroLift and 5% is coming from all other. And I know there has been a question for Teleflex around the core growth or growth outside UroLift, is it sustainable? And we've always said that this is one of the misunderstood things about Teleflex. We always internally were incredibly confident. So that business had the capacity to perform at the level that we are now seeing, and we believe that it is sustainable. And I would add, that's what gives me that belief is that we continue to see our end customer tracing notch up, and it did the same again in the second order. So the end customer demand is there. We had a slight destocking in Q1, restocking in Q2. But if you look at the half year base result also in that 5% range with UroLift adding to a little bit over 3%. So I think that it's very encouraging for Teleflex, because it's so broad based and our entire portfolio is performing well.
Shagun Singh:
And then I just wanted to get an update on pricing. It looks like Teleflex is in price discovery mode for a few key products. For MANTA, it appears that price may be settling in at about $800 to $1,000 range. Even though objects have suggested that price is the biggest value to adoption. And you've seen some pushback from Value Analysis Committees at hospitals for Percuvance. So, can you just give us your take on what is the pricing environment look like currently? And just comment on your ability to achieve the desired level of pricing? Thank you for taking question.
Liam Kelly:
So, regarding the MANTA pricing that would not come through in pricing as of yet, because there's a new product. That's total sale of that will be seen for us as a new product, but regarding your comments on general pricing. Teleflex has always been a pretty unique med tech company and so far as said we have an internal discipline around pricing and that was no different in this quarter. So in this quarter positive pricing in around the 40 or 50 basis points range, which gets us to a year-to-date pricing positive about 30 basis points, so we continue to see this as a strength in the Teleflex portfolio and also in the discipline within our commercial organizations to continue to be able to pay pricing in certain geographies and within certain product categories on an ongoing basis.
Operator:
And our next question comes from Raj Denhoy with Jefferies.
Anthony Petrone:
This is Anthony for Raj actually. Two questions congrats again on the quarter and all the progress here so far. The first one will be on UroLift and the second actually on interventional access. So just non-UroLift, can you give us a sense as a lot of drivers here right now in the U.S.? And so AUA last quarter, there was some clinical data, obviously, you mentioned, Liam favorable reimbursement events in the quarter, but also a competitor had some reimbursement sort of shift against them. So, when you look at all of those drivers, how, is there any one that's kind of leading the charge here? And then on Interventional Access, actually to dig in specifically to the intra-aortic balloon pump business, there seems to be a lot of moving parts in that market right now. So Datascope recently had a recall, and then Abiomed on the Impella side has seen some headwinds in their business. So any color on the balloon pump business would be helpful. Thanks.
Liam Kelly:
Yes. So, we were aware of a competitor recall their stock of the balloon pump. We were that they had a recall on their product. Now, in many instances, for capital equipment, we wouldn't expect to see a massive benefit in that. I will say, though, that are intra-aortic balloon pump business continues to have a very solid second quarter off a very solid first quarter. And we were very pleased with the growth in that and we have a new pump on the market. And regardless of what's happening with a competitor regarding a recall or anything, which wouldn't have really flown through the second quarter, we continue to take share with that new pump on a global basis. And the good thing about the balloon business was it was pretty broad-based. There was solid growth in the Americas. There was solid growth within EMEA and also within Asia. So we feel good on the balloon pumps and a very solid performance. Regarding your question on the UroLift, I've always said it, Anthony, clinical data, patient outcomes will win seven days a week and twice on Sundays. So -- and that will continue. And we just have better clinical data. The reimbursement issue with regard to the competitor, that hasn't flushed through yet either. That's just a guidance, or a, and a, their expectation for the reimbursement. That won't come to be, to fruition until the third or fourth quarter on there. So that couldn't have an impact. In all honesty, what's driving our product is it's better for the patients, it is reimbursed well, but it's better for the patient to get better patient outcomes. We have a world of clinical data. We have excellent coverage. We have every life in the U.S. practically covered now, as per my prepared remarks. And I think we're well on the way so have it be the retreatment for BPH. And I think that it, we are working and we are focused on making UroLift the treatment for BPH. And as we move in from the early adopters to fast followers and we couldn't be happier with the performance of the product.
Operator:
Thank you. Our next question comes from Matt O'Brien with Piper Jaffray.
Kevin Farshchi:
This is Kevin Farshchi on for Matt. Congrats on another great quarter. Two quick ones from me on MANTA, it sounds like the first three months of market release has been successful. Curious, one, what is some of the specific feedback that you've been hearing? And then secondly, you reiterated no material revenue in '19. Can you parse out some of what's holding back commercializing the products a bit faster? I'm thinking about the tailwinds we see in the TAVR market specifically. And then you mentioned it gets more meaningful in 2020. Can you quantify that what contributions might look like to your growth rates? Thanks so much.
Liam Kelly:
Thanks Kevin, thank you very much. So as I prepared, as I mentioned in my prepared remarks, we did begin the U.S. limited market in recent quarter two, and of course we're getting very positive feedback. So, that was feedback that didn't align with the clinical study we just published, which is showing a real short time that you would state which is important for the doc for a getting down to 23 seconds as compared to 6 to 10 minutes and also seeing the reduction in major complications. On the cash market side that we worked on, we have had a very, very high re-order rate from those -- side, which is proving to us that the product is sticky. We aren't getting us the back without too much complication to be honest simply because the product is such clinical evidence behind this and the intervention is the need for the product. The reason that we going to see significant uptick in revenue in that business unit from this product is because we have a divestiture going on and it's a fair time within that business unit where we divested the business. And regarding your question about time through 2020, if you don't mind we'll hold that and until we do give 2020 guidance and we'll exclude some specific in that guidance what we give.
Kevin Farshchi:
Terrific. Very helpful. Thank you.
Operator:
Thank you. And our next question comes from Kristen Stewart with Barclays.
Kristen Stewart:
Hey. Thanks. My first question is just kind of around the growth guidance for the second half of the year especially considering I think you've an extra selling in 4Q. I guess what would be some of the things that you would expect to be contributing to a deceleration in the going to rate again considering 4Q should have a little bit of benefit from the selling day comp? And then I have a follow up.
Thomas Powell:
Yes. Thanks, Kristen. Really there are number of aspects and a number of news moving first of all, the first half of the year we had easier comp comparison. And again in second half, I think we grew by 5.6% and 7.7% in the Q3 and Q4 last year, which is a tougher comp. But what I think first of it, very, very encouraging that we put out our guidance that hasn't growing approximately 7% range even with those tough comps. So, this is a portfolio that we have been trying to build to have a portfolio product that sustain the distributor movement that we saw in quarter one, but also we are reading confident in growing at that 6% to 7% even in tougher comp environment that we would have fact next year. So, that's the encouraging think from our standpoint. Also, as we said, OEM and Internventional access came out as a blast really quick in quarter one and we didn't anticipate maintaining that level of growth. So, therefore we would anticipate that they would be a little bit lighter in the back half. And on the positive side of the ledger I guess, we will see that, perhaps anesthesia and EMEA might do a little bit better in the back half and obviously we have taken up our guidance for U.S. compared to 35% and that's business continues to do incredibly well. If we can continue to invest behind that which we have been doing and been working perhaps that is an area that might help them to gain as we go through the year and into next year.
Kristen Stewart:
Thanks. I was wondering if you can just provide a little bit more detail on what you have said about strengthening IP portfolio and what that exactly means. I'm not sure if you are facing any sort of IP litigation or anything in that regard may be just wash out that commentary a little bit more. Thank you.
Liam Kelly:
What we seen in the market place, is more a company that would perhaps be we would believe in bringing on some of our IP and obviously we will protect and as our investors will expect us to do we will protect our valid right to self product that we invented another real copycat in preferred market. So, we have also spent some significant dollars on the other side of the ledger, reinforcing our IP. We have a number of new products in the pipe that are in our mine pretty exciting and we're trying to get broader coverage from IT profession within the landscape so that in the future this product we run them to our pipeline will be significant generators of brand new growth within the future. So that’s the true aspect of that.
Kristen Stewart:
Is there anything on the IP side related to UroLift?
Liam Kelly:
I don’t want to go into specifics. And please Kristen don’t go to our whole product portfolio, but that is one that we are defending. It is one that we fire though and protect for future.
Operator:
Thank you. And our next question is from Matthew Mishan with KeyBanc.
Matthew Mishan:
Thank you for taking the questions and nice lead up to my question, which is Medtronic lease of products in the quarter that looks similar to guide lines is this something you consider to be a competitor product and some to maybe something close to your patents?
Liam Kelly:
So I guess you talking about the telescope.
Matthew Mishan:
Yes.
Liam Kelly:
Yes, we're aware. That is we've seen in similar markets and in due to course we'll aggressive with the response, Matt.
Matthew Mishan:
Okay fair enough and on RePlas. I guess expedited approvals sounds better to congress and it does to the FDA. But what do you think the time frame looks like now on the BLI submission and then also can you comment on the timing of the potential build out of manufacturing infrastructure ahead of this submission as well.
Liam Kelly:
Let me deal with the manufacturer infrastructure and the math for. The manufacturing infrastructure is already built. We have an up lay in our productivity to address the demand from the total military demand and a portion, a significant portion of the build in demand. I will see in the easy plan and I mentioned this in my prepaid remarks. The collaboration with FDA has been very constructive. The issue here is that for the FDA, and the military are incredibly excited about it because they see this product can have a positive impact on humanity and we're all marching in the same direction but we are in on charter water here. A product like this is never been approved before. We have some additional testing to do math and we will get further update, it would be I think not we're going to give an expected timeline, we're going to run some test between over the next couple of quarters and once we have that test results back I think then I will give you a much clearer view as to when we expect to do this BLA submission. I would say that the FDA are working hand and glove with us and with the military to get this through. We've already agree to protocol for pediatrics, pediatrics were never requirement for fresh-frozen plasma, so we've got that milestone done and many other milestones as we work with them. And we will get further updates on the subsequent calls, Matt, as we go through this testing analysis that we need to do.
Operator:
And our next question comes from Mike Matson with Needham & Company.
Mike Matson:
Just a couple of product related question. So can you just remind us, why the transition to UroLift is going to take as long as it is?
Liam Kelly:
One of the main reasons is because we don't want to disrupt the growth. And we want to be thoughtful about the role of the UroLift 2 within the United States. So we want to make sure that we do it in a thoughtful way so that our sales talent can continue to service existing accounts, bring on new accounts, and then transition new and existing accounts to UroLift 2. I think, it would be almost foolhardy to go to aggressively after disruptive growth. Don't forget, we are, last year we did $200 million and $6 billion market in the United States. And the last thing we want to do is to disrupt that growth. It is one of our five to drive and it's our most important one of the five to drive. So we're going to keep a very close eye on them.
Mike Matson:
And then just Percuvance, I didn't hear that, you call that out as one of the things that sort of the surgery business. So just curious where things stand with that? Thanks.
Liam Kelly:
Thanks Mike. We're still on limited market release, and we will be on, as we said previously, on limited market release through the end of the year. I'm going to get further updates on Percuvance, as we get into guidance for 2020, when we should then come either from an extended limited market release or a full market release. But everything is going according to plan, Mike is what I can say with Percuvance.
Operator:
And our last question is from Brian Weinstein with William Blair.
Brian Weinstein:
So outside of UroLift. I'm curious how much of the growth in the first half is from actual gains versus segment market conditions? In other words, what do you see, it's kind of market growth in your key segments right now? And where do you think you're specifically taking the most share?
Liam Kelly:
So, I would say, if I went through the various business segments. If I went to Vascular Access, let me started at the top of the house Vascular Access. Through the first half of the year, as I said, we grew over 7%, for sure that market is growing into 2% range. So clearly, we're taking share, the areas we're taking shares is for sure within the PICC part of our portfolio where we have an antithrombogenic and antimicrobial PICC. And also we continue to develop the market with the EZ-IO, which also takes care. Interventional Access to that half year. As I said earlier almost 13% and that's clearly a share again, also, that market will be growing in that 4% or 5%. Surgical is again above market, so you have to be taking share Interventional Urology were creating new category. So we're moving patients that will be taking pharma into another area. OEM is again an area is growing above market where we're taking share. Anesthesia is probably the one where it's not taking share. It's growing, maybe modestly below the market in the first half of the year. But again, they've been through some destocking and that's the one area where we didn't seem to restock is a little bit of modest restocking sitting in Anastasia that may come back.
Brian Weinstein:
And then on the DTC stock with UroLift. Can you start to quantify the benefits that you're seeing there or give us any metrics and how that is rolling out? And how you intend to expand that program to help drive UroLift going forward? Thank you.
Liam Kelly:
Thank you for details on how we're expanding it. So last year, we did 6, this year we will do 12. If it's continue to drive accelerated growth. Brian, we might even add a few more the back end of the year. So through the first quarter, we initiated 7 of the 12. So it's clearly working. We get great response. And we're very encouraged by it. We do see, if we compare the DTC market to the controlling market of a similar size. We do see a significant uptake in customers going and patients who now know what the condition they have is called. So many patients that are just getting up 8 to 9 times a night driving their wife and their spouse crazy and now they see the advertising campaigns, they listen to it, we hit them on Facebook, and they now can put a name so what has been called in their condition and they go to their urologists and they have a conversation. And then urologist will defined what the best path for that patient. So, working very well and we're very excited by it, Brian, I think it's the headline.
Operator:
And this concludes our Q&A session for today. I would like to turn the call back to Jake Elguicze with his final remarks.
Jake Elguicze:
Thanks operator and thanks to everyone for joining us on the call today. This concludes the Teleflex Incorporated second quarter 2019 earnings conference.
Operator:
Thank you, ladies and gentlemen, for participating in today's program. You may now disconnect. Have a wonderful day.
Operator:
Good day, ladies and gentlemen, and welcome to the Teleflex Incorporated First Quarter 2019 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Mr. Jake Elguicze, Treasurer and Vice President of Investor Relations. Sir, you may begin.
Jake Elguicze:
Thank you, and good morning, everyone. And welcome to the Teleflex Incorporated First Quarter 2019 Earnings Conference Call. The press release and slides who accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing (855) 859-2056, or for international calls, (404) 537-3406, passcode 6798477. Participating on today's call are Liam Kelly, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks, and then we'll open up the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. With that said, I'd like to now turn the call over to Liam.
Liam Kelly:
Thank you, Jake, and good morning, everyone. It's a pleasure to speak with you again. The first quarter of 2019 was an outstanding start to the year for Teleflex. First quarter revenues grew 4.5% on an as reported basis and 7.6% on a constant currency basis. This was above our initial expectation for quarter one revenue growth. We are particularly pleased with how broad-based the growth was during quarter one, both from a product and geographic perspective. Our strong top line performance was led by 41.5% growth in Interventional Urology, 17.1% growth in Interventional Access and 20.1% growth in OEM. Geographically, we achieved particularly strong growth within Asia and the Americas, where constant currency revenue growth was 11% and 6.7%, respectively. We believe our Q1 performance is an excellent example of the type of diverse, accelerated revenue growth that Teleflex can deliver. Turning to some other key metrics. We reported adjusted gross margins of 56.7%, adjusted operating margin of 23.7% and adjusted earnings per share of $2.24, which represents an increase of 4.2% over the first quarter of 2018. Our adjusted earnings per share performance in Q1 was slightly better than our initial expectations, despite a greater-than-expected headwind from FX as well as year-over-year increases in tariffs. In summary, our quarter one results give us increased confidence in our ability to achieve our previously provided full year 2019 financial guidance and in doing so, deliver on our commitments to shareholders, patients, customers and our 14,000 employees. This morning, we are reaffirming our annual guidance ranges for as reported and constant currency revenue growth, adjusted growth and operating margin and adjusted earnings per share. With that as an overview, let's now look at quarter one revenue in more detail, I will begin by reviewing our revenues by reportable segment, as disclosed in our SEC filings. As a reminder, quarter one is the first quarter we are reporting our segments as you see here. But we are also providing a breakdown of revenues on a global product category basis, which I will discuss momentarily. The Americas delivered revenues of $344 million, which is an increase of 6.7% on a constant currency basis. This is driven by our Interventional Urology and Interventional Access product family. The EMEA reported revenues of $154.6 million, an increase of 4.5% on a constant currency basis, led by our Interventional Access and Vascular products. Asia reported revenues of $60.8 million, an increase of 11% on a constant currency basis, driven by our Vascular, Interventional Access and Surgical products. From a geographical perspective, our business in China grew 11% in the first quarter, and we also saw strength in Korea and Southeast Asia. And lastly, our OEM business reported revenues of $54.2 million, an increase of 20.1% on a constant currency basis, led by strength in catheters and performance fibers. While we are pleased with the quarter one growth rate in our OEM business, we continue to expect this business to grow in the upper single digits for the full year. Now let me move to a discussion on our revenues by global product categories. Starting with Vascular Access, first quarter revenue increased 2.5% on a constant currency basis to a $143.9 million, driven by strong growth in PICCs and CVCs, partially offset by the timing of certain North American-based distributor orders. Moving to Interventional Access. First quarter revenue was $103.2 million, which is an increase of approximately 17.1% on a constant currency basis. The strength in this business during quarter one was broad-based, with growth in legacy Teleflex product lines, like intra-aortic balloon pumps and consumables as well as our OnControl bone marrow product. Growth in these areas was coupled with sales increases and extension of microcatheters as well as biologic products that were part of the legacy Vascular Solutions product portfolio. Our MANTA large bore closure product, which is reported through the Interventional Access product category entered its limited market release in the U.S. during the second quarter. Our strategy for the limited market release continues to be a methodical rollout to ensure strong initial outcomes with key thought-leading physicians as we invest in further building the commercial infrastructure to support MANTA's long-term growth. As such, we continue to expect the revenue contribution from the early commercialization of MANTA in the U.S. to be immaterial to our 2019 results. Now turning to Anesthesia, first quarter revenue was $80.3 million, which is a decrease of 1.5% on a constant currency basis. The decrease seen here is primarily driven by the timing of North American-based distributor orders, which impacted sales of our laryngeal mask products. For a brief update on RePlas, we continue to be focused on completing the BLA submission in the third quarter of 2019. Now shifting to Surgical, revenue increased 5% on a constant currency basis to $86.7 million, driven by sales of ligation clips and surgical instruments. We are pleased to see a rebound in the global constant currency revenue growth rate of our surgical product lines, as, during 2019, we are no longer facing the trocar product line exit headwind we experienced during 2018. Moving to Interventional Urology, revenues increased 41.5% on a constant currency basis to $59.7 million. Our sales force continues to make good progress in driving physician adoption of the UroLift system. As of the end of the first quarter, our field sales force stood at just over 100, approximately 80% of which were sales reps and 20% were sales associates. We will continue to methodically build this commercial team as we move through 2019. From a market penetration perspective, the commercial team has trained just over 2,000 urologists, out of a total of 12,000 urologists in the United States. We have clearly just scratched the surface of penetrating this large market opportunity. Every year, our commercial organization becomes more proficient at changing the way physicians and patients think about treating BPH, offering a truly minimally invasive solution that provides rapid, durable relief with no new onset of sustained sexual dysfunction. We also continue to make progress training the U.S. physician base on using UroLift to treat an obstructive median lobe following the removal of this contraindication from the UroLift label. While the prevalence in the U.S. of obstructive median lobe is low, physicians can now use UroLift to deliver good outcomes to men with this challenging anatomy. Once we finish the median lobe training in the latter half of 2019, we will begin the rollout of the UroLift 2, with a full conversion of the U.S. physician base from UL 1 to UL 2 expected in 2021. And lastly, we continue to actively see the market for the launch of the UroLift in Japan, working with key opinion leaders on preparing for the PMDA mandated post-market clinical trials. As we move through the reimbursement process, we anticipate launching UroLift in Japan, with a limited market release in mid-to late 2020, with revenues ramping more meaningfully in 2021. With over 110,000 patients treated in the United States alone, 272 million covered lives, a sales force of over 100 in the U.S. and the largest highest quality body of clinical evidence in the category, we believe UroLift has established a commanding market leadership position. We are focused on further strengthening that leadership positioning to ensure sustainable high growth of our Interventional Urology business over a multiyear period. The performance of UroLift in the first quarter gives us increased confidence in our full-year guidance, and we are reaffirming our expectations of annual 2019 Interventional Urology growth of approximately 30%. And lastly, since OEM was covered in our segment review, let me summarize first quarter revenue for the businesses within our other category, which consists of our respiratory and urology care products. Revenues were down 5.1% on a constant currency basis, totaling $85.6 million. This was attributable to declines in sales of our respiratory and bladder management products, in fact, due to the same North American-based distributor purchasing dynamics that impacted our Vascular and Anesthesia product lines. That completes my comments on quarter one revenue performance. Next, I would like to briefly discuss some things we planned to highlight at the upcoming American Urological Association, or AUA, meeting. A significant part of strengthening UroLift leadership position over the long term is our commitment to invest in high-quality clinical data. Given that tomorrow is the first day of the AUA 2019 Annual Meeting, I would like to provide some of the key takeaways of the important clinical data presentations that will showcase UroLift. First, is a presentation on the real-world results of 1,413 patients who received UroLift across 14 sites in North America and Australia. Results were consistent with those seen in previous clinical studies of the UroLift System, even with a more diverse patient population. Next, is a study that looks at symptoms and sexual function outcomes in all types of prostates, including those with obstructive median lobes. Findings from of the study suggest that patients with all type of prostate enlargements experienced symptom improvement and preservation of sexual function. The third study examined the use of UroLift in 52 patients, with acute urinary retention, a condition often found in late-stage BPH patients with poor bladder health. The results demonstrated that 79% of patients were catheter free within three months, and 96% reported being much or very much better at six months. And lastly, there will be a study that examines the impact, if any the UroLift implants have on the MRI readings of patients with significant cancer. Results from the study show the UroLift System is unlikely to obscure prostate cancer readings for patients receiving MRI screening. As of the end of [indiscernible] UroLift has 29 publications on its safety and efficacy. As you can see, we continue to invest in building this industry-leading body of clinical evidence and deepening physician understanding of its capabilities and outcomes in real-world settings. Ultimately, we believe this evidence will drive continued adoption of the UroLift System by more physicians and contributes to making UroLift the standard of care for the treatment of BPH. In closing, I would like to reiterate how pleased we are with our first quarter results. Revenue growth was broad-based. We continue to proactively invest in our higher-margin product opportunities, and we achieved an adjusted earnings per share results that slightly exceeded our initial expectations, all of which positions us well for the remainder of 2019 and beyond. That completes my prepared remarks. I would now like to turn the call over to Tom for a more detailed review of our first quarter financial results and full year 2019 guidance. Tom?
A - Thomas Powell:
Thanks, Liam, and good morning, everyone. Given the previous discussion of the company's revenue performance, I'll begin at the gross profit line. For the quarter, adjusted gross profit was $347.8 million versus $332.6 million in the prior year quarter or an increase of approximately 4.6%. Adjusted gross margin increased 10 basis points versus the prior year period to 56.7%. The expansion in adjusted gross margin primarily reflects increased UroLift sales volumes as well as cost benefits from both of our restructuring programs and manufacturing continuous improvement programs. Offsetting these gains were negative impacts from foreign exchange, incremental tariffs and inflation. Adjusted operating profit was $145.6 million as compared to $141 million in the prior year. Adjusted operating margin in the first quarter was 23.7% or a decrease of 30 basis points over the prior year period. The negative impact from foreign exchange, incremental tariffs and inflation that adversely impacted gross margin also flowed through to impact operating margin. Additionally, as was planned, we increased commercial investment in UroLift and MANTA during the quarter. On a currency neutral basis, adjusted operating margin would have been approximately 24.6%. Continuing down the income statement. Adjusted net interest expense decreased to $22.4 million from $25.7 million in the prior year quarter. The decrease primarily reflects the impact of the cross-currency swap that was completed in the fourth quarter of 2018. For the first quarter, our adjusted tax rate was 14.8% versus 12.8% in the prior year period. The increase in our adjusted tax rate is primarily due to the mix of earnings in higher tax jurisdictions during the first quarter of 2019 as compared to the first quarter of 2018 as well as a reduced amount of windfall benefit from stock-based compensation. Adjusted earnings per share came in at $2.24 or an increase of 4.2% as compared to the first quarter of 2018. This result includes a foreign currency headwind of $0.17 per share, the incremental year-over-year tariffs of $0.05 per share and a headwind from the divestiture of our catheter reprocessing business, which contributed $0.01 per share to the prior year quarter. Turning now to select balance sheet and cash flow highlights. For the first quarter of 2019, cash flow from operations totaled $60.2 million compared to $86.8 million in the prior year period. The decrease is primarily attributable to increased consideration payments during the quarter. Finally, debt outstanding at the end of the first quarter was largely unchanged from the fourth quarter of 2018. Of note, during the first week of the second quarter, we entered into an amended and restated credit agreement, which provides for a $1 billion revolving credit facility and a $700 million term loan. The new credit facility contains a leverage covenant, which requires the company to maintain net leverage below 4.5 times and this compares to our previous credit agreement, which requires the company to maintain gross leverage below 4.5 times. Our net leverage level as defined under the new credit facility stood at approximately 2.7 times at the end of the first quarter. And this completes my comments on the first quarter results. Now, I'll move to 2019 guidance update. We are reaffirming our previously provided full year constant currency revenue growth guidance range of 6% to 7% as well as our reported revenue growth guidance range of 5% to 6%. We're also reaffirming our previously provided GAAP and adjusted gross margin guidance ranges and our adjusted operating margin guidance range. However, we have reduced our full year GAAP operating margin guidance from a range of 17.4% to 18.1% to a revised range of 17.2% to 17.9%. The reduction is a result of additional contingent consideration expense as well as an impairment of certain intangibles that we deem to have no longer value. Moving to interest expense. We continue to expect full year interest expense to be between $87 million and $90 million. However, we expect to be closer to the low end of that range. We reduced projection as a result of our current expectation for the Fed to maintain rates at current levels versus a previous expectation of rate increases in late Q1 and again in Q4 of 2019. Of note, the projections include the interest benefit from the $250 million interest rate swap completed in March. Turning to taxes, we continue to expect that our full year 2019 adjusted tax rate will range between 14% and 14.8%. That takes me to our GAAP EPS and adjusted EPS ranges. We reaffirm our previously provided adjusted EPS range of $10.90 to $11.10. However, for the reasons previously outlined in connection with our GAAP operating margin, we are reducing our full year GAAP EPS range from $6.90 to $7.05 to a revised range of $6.72 to $6.84. As a reminder, our adjusted EPS guidance range includes foreign exchange, tariff and inflation headwinds and the divestiture of our catheter reprocessing business. The range also contemplates an increased level of investment into certain of our higher-growth and higher-margin product categories. Overall, we are pleased with our expectations to grow full year 2019 earnings by 10% to 12% while also funding investment behind key revenue growth opportunities, and while also offsetting headwinds from foreign exchange and tariffs. In closing, I'd like to reiterate our perspective that the first quarter was an excellent beginning to 2019 for Teleflex. We are pleased with our above expectation constant currency revenue and earnings per share results of 7.6% and $2.24, respectively. We believe the strong Q1 sets us up nicely to achieve our previously provided full year 2019 financial guidance. And that concludes my prepared remarks. Now I'd like to turn the call back over to the operator for Q&A.
Operator:
Thank you. [Operator Instructions] Our first question comes from David Lewis with Morgan Stanley. Your line is now open.
Mason Edward Oliva Austen:
This is Mason on for David. I just wanted to start out with Interventional, a pretty strong quarter out of this segment. I was wondering if you could just parse out the drivers here and how sustainable do you see this growth in 2019? And then I just had one quick follow-up.
Liam Kelly:
Yes, it's Liam here. So we – our Interventional business performed very well in the quarter. We're very happy. What we're increasingly positive on is how broad-based the growth was. As I said in my prepared remarks, our legacy Interventional business performed well, in particular, our intra-aortic balloon pumps and catheters had a stellar quarter as did the microcatheters, the GuideLiners, the TrapLiners and the biologics from the old – or the VSI business that we acquired. We still expect that on a full year basis that the Interventional business will grow in the high singles, maybe even sneaking into the double digits with some better execution into the latter half of the year. So I think we're quite bullish on our Interventional Access. Again, what I'm particularly pleased about is it is one of the areas that we highlighted that would be a growth driver in the year and it has started off incredibly strong.
David Lewis:
Great. Liam, it's David Lewis. Sorry about that. I just want to kind of jump in here with the second question. So, Liam, when I think about the back half of the year comps get a little harder, but the pipeline improves. You have some selling day dynamics. How should we think about first half versus second half growth at this point? And then related to that, just thinking about NeoTract, you talked about 30% outlook for that business this year. That business well above trend here in the first quarter. How are you thinking about NeoTract into the back half of the year as we think about back-half growth?
Liam Kelly:
Yes. So for our overall business, I think, David, we're very happy with the start. I'm not too sure that we should focus too much on the comps because if you look back to last year, our toughest comp was Q3 last year, and we had a very solid Q3 in that year. So addressing your NeoTract and what I expect, I guess, your question is really around headwinds and tailwinds for a large extent. So from a headwind perspective, we got the catheter reprocessing business that we exited during the year. OEM is not going to grow at 20%. We don't expect OEM to grow at 20% in the year. So it should set us down to higher single digits on a full year basis. And then from a tailwind perspective of where we continue to see growth, we had some destockings of distributors in Vascular, Anesthesia and the Other category. As I said, Interventional Access will do the high singles, maybe sneak into doubles. APAC to the high singles and Surgical, I'm really happy to see Surgical recover and it should be in that mid-single-digit range on a full-year basis. Regarding NeoTract, it obviously started really, really strong and posted 41.5% growth. Now the 30% is a full year number, David, and we're very encouraged by the start. Obviously, as we get into later in the year, we will look at sharpening our pencils on some of our guidance ranges, but I got to tell you I couldn't be happier with the start. And I think we've got a great setup for the full year. First half will – we don't have the tougher comps in the second half, but it's a great start and it's a great setup from where I look at it, David.
David Lewis:
Great. Thanks so much, Liam.
Operator:
Thank you. And our next question comes from Lawrence Keusch with Raymond James. Your line is now open.
John Hsu:
This is John Hsu on for Larry. If we could start just on the incremental $15 million spend that you had talked about UroLift and MANTA, how much was realized in the 1Q? And just how do we think about gating for the remainder of the year?
Thomas Powell:
So as we think about that $15 million spend, we certainly continue to expect to spend the full amount for the year. I'd say that in the first quarter, we didn't spend 1/4 of that total amount, it's a little more than $1 million overall in the quarter. As we think about how that plays out in the year, you should expect to see the majority of that really going forward in Q2 and Q3.
John Hsu:
Okay. Great. And then I guess a specific on UroLift. Do you see a scenario where there is – where there – you could get reimbursement process in Japan a little bit faster than I think your mid-2020 expectation? And then just the second one on UroLift. With UroLift 2, it sounds like it's still tracking for a launch later this year. So how long do you think it will take to realize the higher 70% plus or the high-70s GM for the second UroLift product?
Liam Kelly:
Yes, so I will deal with the conversion of UroLift 2. As I said in my prepared remarks, we will have the conversion completed by 2021 and at that stage you will see the full benefit of the gross margin pickup. Obviously, as we ramp up in later 2019 and in particular, in 2020, you'll see the pickup of that gross margin benefiting in 2020. But it will be fully realized when we have the total U.S market converted by 2021. From the Japan perspective, as I said in my prepared remarks, we expect to get reimbursement in mid-to late 2020. And then, we'll start to roll out – we're already ceding the markets right here today, and we're aiming for that midyear approval. But as we said, we expect that in mid- to late 2020. Now in our LRP, I got to tell you that we had very little revenue in – for Japan in 2021, practically none. So if anything, this is a positive for us.
John Hsu:
Okay. Great. And if I could sneak in one more? Can you just remind us about the items that are masking the free cash flow generation this year? And then how you see those progressing through the remainder of the LRP?
Thomas Powell:
Well, really, when you look at the first quarter results, the impact of cash flow from ops is coming from increased contingents consideration. So as a result of change in estimates in the quarter, that's actually reduced our cash flow from ops by about $30 million. And so as we look at the full year, we still expect to be on our full year plan. But again, compared versus a year ago, it's a contingent consideration change.
John Hsu:
Okay. Great. Thank you so much.
Operator:
And our next question comes from Richard Newitter from SVB Leerink. Your line is now open.
Jaime Lynn:
Hi, this is Jaime on for Rich. I guess the first question I have you guys had mentioned that you guys have experienced some decreases due to distributor order timings. So I was wondering if you can just give us a little bit of a greater sense of kind of what happened with that in the quarter? And then is that something that you expect to make up throughout the remainder of the year?
Liam Kelly:
Well, I think, that's – what we've been saying about Teleflex is as we roll all of the businesses into organic, what you'd expect to see is let the cord with the distributors. So in the past, about half of our business went through these distributors and moving forward now in this quarter, about one-third. And I think a great thing from a Teleflex perspective is that we're able to cushion ourselves against these distributor movements. So what we saw in the quarter was definitely some destocking even more than we had anticipated. We would expect that to come back during the year in 2019, but we were able to offset that with excellent performance within the remainder of our businesses that are not exposed to distributors, and thereby overcoming that and to post a – the number that we did from a growth perspective, I think we're very encouraged by.
Jaime Lynn:
Okay. Great. And then just a housekeeping thing, I'm sorry if I missed it, but did you give what the actual dollar amount was for UroLift in the quarter?
Liam Kelly:
Yes, we did. We said that...
Thomas Powell:
$59.7 million.
Liam Kelly:
We said that the Interventional Urology business posted $59.7 million in the quarter.
Jaime Lynn:
Okay. Thank you.
Operator:
Thank you. And our next question comes from Matthew Mishan with KeyBanc. Your line is now open.
Matthew Mishan:
Liam, just a follow-up to that previous question. Kind of why are you seeing distributors destocking? Is this – has it been persistent where they're taking their inventory levels even lower than you would think?
Liam Kelly:
So I don't think it's a question of them taking their inventory levels much lower. You see a different dynamic with some distributors. Some hold more stock than others. Some hold 30 days, but some have confidence with their customers whether they will hold 45 or 60 days depending on the contract with their customers. They can't go below that stocking level. What you see – and it's not as organized, Matt, as you and I might think, as some of these distributors will have 40 centers throughout America. And they will place their orders on a Tuesday night and it all rolls up and comes to us by – overnight on Tuesday night. It just ebbs and flows. On a full year basis, Matt, it always balances out. And with less of our business exposed to it, I'm not as concerned about that in 2019. It's not going to be as big an impact to Teleflex quarter-over-quarter in 2019 as it may have been in 2018 than previous years.
Matthew Mishan:
Okay. And then how sustainable is the growth, the double-digit growth you're seeing in Asia moving forward? Is that something you can count on given some of the investments you've made? And then, obviously, with UroLift coming on stronger in Japan by 2020?
Liam Kelly:
Yes. With our NRP for Asia, that is growing in the high single, maybe sneaking into the double digits. And that's still our expectation. Obviously, we would have some of those levers that would accelerate it in the outer years. So this year, our expectation is high singles. Asia-Pacific is off to a great start. Again, Matt, we're very encouraged. And again, it was pretty broad-based coming from the Vascular Access products, Surgical products and Interventional products. So again, like all of our business and that's what most encouraging is that we've been ramping, Matt, since the second half. And we've been building momentum since the second half of 2018. And now we see a 7.6% posted in Q1 as broad-based geographically and from a product perspective.
Matthew Mishan:
Right, thank you.
Operator:
Thank you. And our next question comes from Matt Taylor with UBS. Your line is now open.
Matt Taylor:
Hi, thank you for takng the question. So the first question I wanted to ask was just about the guidance. I mean given your really strong start here, I totally get that you have more confidence in the year. Can you just talk about, philosophically, would you ever raise guidance in Q1 or you're just being a little bit conservative on the overall picture and on UroLift because to start out here, you're well ahead of the annual forecast?
Liam Kelly:
Thanks, Matt. Yes, so look, we feel really great about the business. As you see from the performance in Q1, again, as I said, it's broad-based. We think that this continues the remainder of the year. As we think about our 2019 guidance, I think we've put ourselves in a very strong position to meet or exceed our revenue projection. And we intend to work on delivering on our commitments to our shareholders. As we go through the year, Matt, we'll take an opportunity to have another look and sharpen our pencils, but we won't water down an excellent quarter. We're very bullish as we have been all year for our revenue growth. Regarding UroLift, I think that looking at UroLift, it's a great start, again, great first quarter tucked under the belt. The 30% approximately growth is a full year number. It's a great – it's a good start. We have a weaker comp actually in UroLift in Q3, which encourages us also because of the voluntary recall we did in Q3. And if you recall last year, we actually addressed the UroLift revenue growth as we went through the year. And hopefully, we'll be in a position to do that again this year. It's a very promising start, Matt.
Matt Taylor:
And I was hoping maybe you could just unpack the Interventional Access growth? Can you talk about the growth of some of those different pieces that you highlighted that are doing well?
Liam Kelly:
So as I said, the Interventional business was, again, broad-based. I think we saw some – I'll cover a couple of them. I don't want to get into the too many of the weeds here, Matt. But if you look at the OnControl, that grew nearly 20%. If you look at the catheter extensions, it grew around 15%. If you look at microcatheters, that was up above 30% and biologics too was well up in those numbers. If you look at our intra-aortic business, that had a very solid start, well up in the double digits, over – up around 30%. So broad-based, Matt.
Matt Taylor:
Thank you very much.
Operator:
Thank you. And our next question comes from Matt O'Brien with Piper Jaffray. Your line is now open.
Kevin Farshchi:
This is Kevin Farshchi on for Matt today. Congrats on the nice quarter. I wanted to start, going back to NeoTract growth, again, exceptional off of those tough comps. I just wanted to put a finer point on that outperformance. Was there something different this quarter than previous ones from a trend perspective, specifically as you're looking at utilization in existing accounts? And second, if you could talk a little bit about the additional resources you're putting behind the program from the DTC perspective, and how do you think about that expanding for the rest of the year? Any kind of metrics you can provide on those two fronts that contributed to the momentum. And I have one follow-up.
Liam Kelly:
Yes. So I think the most important metric that we look at is the number of urologists that we've trained. So we've trained just over 2,000 urologists within the United States. There are 12,000 urologists within the United States. We've generated almost $60 million in revenue with only 1/6 of urologists trained in United States. Regarding your question on where the revenue is coming from, from an account perspective, we continue to see 60% of the revenue coming outside of the hospital environment either the ASC or in the office. So we continue to see momentum building in that area. So no change in the size of service. No change in where we see the revenue coming from, and we continue to be very positive on the metric of the training of urologists getting over 2,000 out of 12,000. I think the same-store sales, we continue to see an increase in same-store sales quarter-over-quarter. And that's what we've seen for the lastthreeyears within this product category.
Kevin Farshchi:
Thank you. That's super helpful. I just had a follow-up on that business as well. You mentioned on the call that you're increasing that 100 group of RePlas associates to kind of meet the demand. Could you remind us a little bit on the rep productivity numbers as they stand today? How are they trending versus last year? And then if you could provide any color on the expectations for that to increase with UroLift 2 in the product bag and those additional reps? Thanks.
Liam Kelly:
So I'll answer the last part of it first. You wouldn't expect any rep productivity just by launching UroLift 2. The UroLift 2 will reduce clinical waste for the urologists, which is a positive. It will reduce their costs of disposing of that waste than it will improve our margins. But there isn't a pricing play to go there. The productivity per rep annualizes in or around $3 million per rep, which is at the higher end one would expect from a sales representative, but obviously, this is a very fast-growing product. The continued investment that you asked about, obviously, we're doing DTC or doubling the number of DTCs that we did during the year. And we will continue to add reps during the year. Our normal cadence that we've said that we expect is to add around 15 sales heads every year. Now we've gone above that for the last two years since we've owned this asset just because we're – as we said, not all growth is equal in Teleflex, and we're investing behind the areas where our margins are better. And this is definitely one of them, so is Interventional Access, so is Asia. So that – you can expect that continued investment from Teleflex in areas where our margins are better and therefore getting some leverage in our income statement.
Kevin Farshchi:
Okay, perfect. Thanks again. And congrats on the quarter. Thanks.
Liam Kelly:
Thank you very much.
Operator:
And our next question comes from Brian Weinstein with William Blair. Your line is now open.
Brian Weinstein:
Hi guys, thanks for taking my questions. Starting with maybe just PICCs and CVCs, just a little bit more commentary maybe on what's going on there, just in general. Haven't heard a whole lot of update from you guys in the last couple of quarters on those products, so just what do you see in there? And what type of share do you guys think that you guys have now within the PICC category? I know you're continuing to gain it at a pretty healthy clip.
Liam Kelly:
Brian, thanks for the question. Yes, look, I'll start with PICCs. Our PICC growth was almost 13% within the quarter. We continue to take share, in particular, within the key North American markets. We now believe we are number two behind Bard, and we believe that we're growing and continuing to take share and we'll continue to become a strong number two. Our PICC business or – pardon me, our CVC business had a nice solid quarter even with the destocking. And we grew around 4.5% in the quarter on our CVC business. And again, these are all areas that are accretive to our margins and therefore help state the leverage within our income statement that I mentioned earlier. I can't reiterate enough the philosophy within Teleflex is not all growth is equal, and we're trying to drive growth in areas and we are succeeding in driving growth in areas that allow us to, again, expand our margins on top of the restructuring programs that we have in place.
Brian Weinstein:
Great. Thank you for that. And then the obligatory M&A question here. You guys clearly have the capacity to be doing something. Can you just give us an update on how you're thinking about M&A, and maybe talk about the funnel and kind of pace of things that you guys are thinking about internally? Thank you.
Liam Kelly:
Thanks, Brian. Yes, I think our leverage ratio is 2.75 times net at the end, so we're down below 3 times. It obviously gives us the ability and the capacity. We are acutely aware that we want to get credit for the good M&A, and we've got an excellent track record of doing excellent deals, and we would envision that continuing. We have patients, we continue to be active in this space. We continue to look at assets. And, obviously, we will continue to make progress in that area. The great thing I think from a Teleflex perspective is that where a patient and we also don't see any need to do an acquisition. We feel very comfortable with the performance of our business with or without M&A, but obviously, as an accelerator, we would like to continue – don't take that comment to mean we're not going to continue to do M&A. We are a serial acquisition company. It's a core competence of ours. And I think there's few better than Teleflex of identifying these assets and bringing them into our organization.
Brian Weinstein:
Thank you.
Liam Kelly:
Thanks Brian.
Operator:
And our next question comes from Anthony Petrone with Jefferies. Your line is now open.
Anthony Petrone:
Thanks. Congrats on a good start to the year here. I have one on UroLift and one on MANTA. First one on UroLift. I know there was a reimbursement shift earlier in the year for a competitor. The numbers were ahead of our expectations for UroLift in the first quarter here. Just wondering if the shift in reimbursement is having any impact in the landscape out there? And I'll come back with the follow-up.
Liam Kelly:
So I think the reimbursement for the competitor, from our understanding is least, made the procedure for the competitor really an office-based procedure. I actually don't think it has had any material impact on our growth. We're very focused on going deep rather than going wide and building this business in the right way. And as you can see from our growth in the first quarter, the numbers speak for themselves. We don't see that competitor having a significant impact or any impact on our growth. I still believe and I've always believed clinical outcomes will win seven days a week and twice on Sundays. And our clinical outcomes are just better. It's that simple. And we're fastly becoming the standard of care for the treatment of BPH.
Anthony Petrone:
And then just the follow-up on MANTA, maybe just an update, I know that I think your comments suggest that there is only minimal benefit from that product. This year we're coming off of a pretty heavy data cycle with low risk data in TAVR showing benefits there. The numbers in TAVR are still very healthy. So I'm just kind of wondering, what kind of contribution this year from MANTA? But as you look outward, as the TAVR market continues to expand, do you have any updated thoughts on what that can contribute? Thanks again.
Liam Kelly:
Yes. Thanks, Anthony. Look, we're very excited about MANTA. I think in time this will be seen as one of those another very nice acquisitions that Teleflex did. And as I mentioned in my prepared marks, we're just commencing the U.S. limited market release in Q2. We are testing some pricing we're making sure that we get our training to the right level so that the product becomes very sticky within the TAVR centers. The great thing also is it's a very focused market. You've got less than 600 TAVR centers within the United States. And the TAVR market, as we know, is growing around 17%. Again, I'll go back to the clinical data, it's very compelling, 70% reduction in major vascular complications which should save a hospital five additional days in the hospital for those major complications and 18,000. And that's why we're testing some pricing scenarios in the limited market release. But we don't expect significant revenue in the U.S. in 2019 as we roll out that limited market release, Anthony. And we'll give more guidance as we get into 2020 as to what we expect from MANTA.
Anthony Petrone:
Thanks again.
Operator:
Thank you. And our next question comes from Kristen Stewart with Barclays. Your line is now open.
Kristen Stewart:
Hey, good morning guys. I was just wondering, just in terms of – I had a clarification for Tom. I think he had mentioned that the GAAP EPS number was going lower just because of an intangible impairment. What was impaired, I guess, or will be impaired?
Thomas Powell:
It's a minor impairment, $3 million in size. So in connection with the QT Vascular acquisition, an option for a future product was included in that transaction, and we've decided not to pursue that future product. And as a result, we've written off the option.
Liam Kelly:
Yes. It was an auction [indiscernible] coatings, and just with the recent announcement, we don't believe we'll be exercising that into the future. So that’s a fairly modest impairment.
Kristen Stewart:
Got you. Okay. And then just as you're, I guess, looking out for the balance of the year, I guess, just to point out you do have one less selling day in 2Q, correct? So that will be about 100 basis points to growth. Is that right?
Liam Kelly:
Yes. It's about – it's normally about 100 basis points, and we pick that day back up in Q4, just to be clear. And again if I am ever going to have a billing day and if I'm going to pick a quarter, the quarter I want to be in is Q4.
Kristen Stewart:
Okay. That sounds good. And then last kind of question, just another kind of follow-up from one of the other questions. On UroLift 2, why does it take so long to roll it out in the U.S.? And if you're kind of starting later this year, why would it take a full year to roll out? Is it something that you could possibly do on a more expedited basis that could help drive a little bit more margin expansion?
Thomas Powell:
So we're – again, we're trying to be thoughtful on this. And the reason that we are being – taking our time, if I can put it that way, is we want to be methodical. We do not, under any circumstances, want to impact the growth of this product because of training divisions on a new product. So we want to keep the growth accelerating at a level that it can do over the next number of years while converting those physicians. And also as a reminder to what I said previously, we are also going back to some of the urologists who are only doing a smaller number of cases every month to retrain them on the new technology to develop those clinicians as champions. Now that they have seen the rapid adoption of the UroLift product, I think they'll be more encouraged to become champions and not get behind the growing trends to use UroLift for the treatment of BPH as it becomes the standard of care.
Kristen Stewart:
Okay. Thanks so much guys.
Thomas Powell:
Thank you.
Operator:
[Operator Instructions] Our next question comes from Mike Matson with Needham & Company. Your line is now open.
Mike Matson:
Good morning, thanks for taking my question. Just have another one on UroLift. So in Japan, are you selling the product through a direct sales force or a distributor? And do you expect the pricing to be higher or kind of in line with the U.S. or lower?
Liam Kelly:
So in answer to your first question, Mike, our intention is to build out a sales force within Japan. In this year, 2019, we will be putting some feet on the street in Japan to do some market development work with key opinion leaders as I said in my prepared remarks. With regards to reimbursement, we would envision and we don't know what the reimbursement rate is going to be until we get it. We feel that the Japanese authorities, given that there is such a close alignment between the Japanese Urology Association and the American Urology Association, we would envision that it would be reasonably close to that level of reimbursement in Japan that we have in the United States, which is a – we would be happy with that result, let me put it that way.
Mike Matson:
Okay. Thanks. And then, Tom, just wondering if you could quantify the tariff impact, and if we do have a trade agreement here and the tariffs go away, how much would that add to your margins for the remainder of the year?
Thomas Powell:
Sure. As we look at the tariffs for 2019, we're currently estimating the impact to be about $9 million on a full year basis. So if those tariffs were to go away in future quarters, we'd estimate potentially a $6 million benefit for quarters two, three, and four. And again, that's assuming you'd get all of quarter two.
Mike Matson:
Great. Thanks.
Operator:
Thank you. I am not showing any further questions at this time. I would now like to turn the call back over to Jake Elguicze for any closing remarks.
Jake Elguicze:
Thank you, operator, and thanks to everyone for joining us on the call today. This concludes the Teleflex Incorporated First Quarter 2019 Earnings Conference Call.
Operator:
Ladies and gentlemen, thank you for participating in today's conference. This does conclude today's program, and you may all disconnect. Everyone, have a wonderful day.
Operator:
Good day, ladies and gentlemen and welcome to the Teleflex Incorporated Fourth Quarter 2018 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to Mr. Jake Elguicze, Treasurer and Vice President of Investor Relations. Sir, you may begin.
Jake Elguicze:
Good morning, everyone and welcome to the Teleflex Incorporated fourth quarter 2018 earnings conference call. The press release and slides to accompany this call are available on our website at www.teleflex.com. And as a reminder, this call will be available on our website and a replay will be available by dialing 855-859-2056 or for international calls, 404-537-3406 passcode 3059948. Participating on today’s call are Liam Kelly, President and Chief Executive Officer and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks and then we will open up the call to Q&A. Before we begin, I’d like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are in fact forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. With that said, I would like to turn the call over to Liam.
Liam Kelly:
Thank you, Jake and good morning everyone. It’s a pleasure to speak with you again. Let me start by saying how pleased we are with our fourth quarter results and the strong finish we saw to the year. We executed well across many of our business units, particularly in the second half of 2018. This was led by performance within our Interventional Urology North America, Interventional Access North America, Asia and OEM businesses. As expected, we gained momentum as we moved throughout the year delivering accelerated organic revenue growth in the second half of the year as compared to the first half, resulting in full year organic constant currency revenue growth of 5.1%. This top line achievement, coupled with continued execution on various restructuring initiatives drove approximately 18% adjusted earnings per share growth during 2018. We also achieved several important clinical and regulatory milestones that should position us well for the next several years. Some of those milestones include
Thomas Powell:
Thanks, Liam and good morning everyone. Given the previous discussion of the company’s revenue performance, I’ll begin at the gross profit line. For the quarter, adjusted gross profit was $369.3 million versus $336.3 million in the prior year quarter or an increase of approximately 10%. Adjusted gross margin increased 110 basis points versus the prior year period to 57.6%. The expansion in adjusted gross margin primarily reflects efficiencies related to higher UroLift and Interventional Access sales volumes, favorable pricing and a positive impact from foreign exchange. Turning to operating profit, for the quarter, adjusted operating profit was $169.9 million versus $151.2 million in the prior year quarter or an increase of approximately 12%. Adjusted operating margin in the fourth quarter of 2018 was 26.5%, which is an increase of 110 basis points over the prior year period. Adjusted net interest expense decreased to $23.1 million from $23.5 million in the prior year quarter. The decrease reflects the impact of our recently completed cross-currency swap transaction, which provided an interest benefit of approximately $3.3 million in the fourth quarter of 2018 and this was offset by higher interest rates on our floating rate debt. For the quarter, our adjusted tax rate was 11.7% versus 10.9% in the prior year period. On the bottom line, adjusted earnings per share increased 13.5% to $2.77. Turning now to balance sheet and cash flow highlights, for the full year 2018, cash flow from operations totaled $435 million, up approximately 2% over the prior year. The increase is attributable to favorable operating results partially offset by higher income tax payments in 2018 as compared to 2017 and a net unfavorable impact from changes in working capital. Finally, our debt outstanding at year end was largely unchanged from that of the third quarter. Our leverage level as defined under our credit facility stood at approximately 3.2x. Overall, 2018 was a solid year for Teleflex. On a full year basis, organic revenue grew by 5.1% and constant currency grew by 12.7%, gross margin and operating margin each expanded by 110 basis points and adjusted EPS increased by 17.9%. And this completes my comments on 2018. Now, I will move to 2019 guidance. In 2019, we project constant currency revenue growth of between 6% and 7% with Interventional Urology, Interventional Access and Asia being key contributors to growth. Our expectation is that the revenue decrease caused by the recently completed divestiture of the vein reprocessing product line will be offset by recent acquisitions, including MANTA. During 2019, we expect a 1% headwind from foreign exchange with the greatest impact being the first and second quarters. As a result, we expect our as-reported revenue to increase between 5% and 6% during 2019. This would equate to a dollar range of between $2.571 billion and $2.595 billion. Turning next to gross margin, during 2019, we anticipate that adjusted gross margin will increase between 90 and 140 basis points to a range of 58% to 58.5%. We expect gross margin expansion to be driven by Interventional Urology, Interventional Access and other favorable product mix. Additionally, we expect continued benefits from manufacturing productivity improvement programs and from previously announced footprint restructuring programs. Somewhat offsetting the gross margin expansion, are anticipated headwinds from incremental tariffs, inflation and foreign exchange. Moving to adjusted operating margin, during 2019, we anticipate that adjusted operating margin will increase between 80 and 130 basis points to a range of 26.5% to 27%. This range includes proactive investments in support of the U.S. launch of MANTA, pre-commercial UroLift market development in Japan and expansion of UroLift direct-to-consumer campaigns in the U.S. That takes me to our adjusted earnings per share outlook for 2019 and this slide serves as a bridge from our full year 2018 adjusted EPS result to our full year 2019 adjusted EPS outlook beginning with 2018 adjusted earnings per share of $9.90. From an operating standpoint, in 2019, we project our core operations to add approximately $1.66 to $1.71 per share or an increase of approximately 17%. We expect to generate a significant level of operating leverage through accelerated revenue growth, favorable mix and manufacturing and cost reduction initiatives. In 2019, we expect interest expense to range between $87 million and $90 million. The year-over-year reduction of $12 million to $15 million will contribute to an estimated $0.25 to $0.30 of earnings accretion. The year-over-year reduction in interest expense is largely the result of the cross-currency swap completed in October 2018 and our planning assumption that free cash flow will be used to further reduce debt outstanding. The projection also assumes two U.S. interest rate hikes during 2019. Lastly, should capital markets remain receptive we will look for opportunities to further optimize the capital structure. Moving to taxes, during 2019, we project that our adjusted tax rate will be in a range of 14% to 14.8% and will result in adjusted earnings per share headwind of approximately $0.30 to $0.40. The expected year-over-year increase in adjusted tax rate is a result of a higher mix of U.S. taxable income in the 2019 operating plan. Additionally, our assumption is that the 2019 windfall benefit from stock-based compensation is at a normalized level versus the atypically high level we realized in 2018. Foreign exchange is expected to be a headwind of approximately $0.20 while increased tariffs are expected to be a headwind of approximately $0.15. We estimate that weighted average shares will increase to 47.2 million for full year 2019, which is dilutive by approximately $0.10 per share. And finally, the divestiture of the vein reprocessing business will remove approximately $0.06 of our adjusted EPS base. So despite a number of headwinds, our outlook for 2019 adjusted earnings per share remains robust at $10.90 to $11.10 and represents growth of between 10.1% and 12.1% versus 2018 or growth rate double that of our expected as-reported revenue growth. While it’s not our practice to provide specific quarterly financial guidance, it has been our practice at the outset of each year to highlight some considerations regarding variability between our quarterly expectations. As for the number of shipping days, 2019 has the same number of total days as to 2018. There’s one less day in the second quarter and one more day in the fourth quarter. For the first quarter of 2019, we expect to realize approximately 23.5% of full year as-reported revenue. We further expect to realize approximately 19.5% of our full year adjusted earnings per share. These estimates reflect our expectation that the adverse impact from foreign currency will be the greatest during the first quarter. And that concludes my prepared remarks. I would now like to return the call back to Liam for closing commentary.
Liam Kelly:
Thank you, Tom. In closing, we are excited for what 2019 holds for Teleflex. We expect as-reported revenue growth of between 5% and 6% and constant currency revenue growth of between 6% and 7%. And despite foreign exchange, tariff and tax headwinds as well as the decision to accelerate certain investments to support sustained organic revenue growth over the long term, we expect another year of strong adjusted earnings growth that is double the rate of our forecasted as-reported revenue growth. Looking over the 2019 to 2021 timeframe, our previously provided financial projections of average organic constant currency revenue growth of between 6% and 7%, adjusted gross margin of between 60% and 61% and adjusted operating margin of between 30% and 31% remain very much on track. That concludes my prepared remarks. Now I would like to turn the call back to the operator for some Q&A.
Operator:
Thank you. [Operator Instructions] Our first question comes from David Lewis with Morgan Stanley. Your line is open.
David Lewis:
Good morning. Liam, I wanted to start with guidance and then maybe a follow-up on NeoTract. So yes, I am sort of thinking about the 6% to 7% constant currency for 2019 and what I consider the impact of NeoTract, Vidacare and VSI and your commentary around limited expectations for MANTA, Percuvance, RePlas, I guess the question I want to ask you is if we think about the 6% to 7%, is the 6% or low end of that guidance range realistic, what gets you to that low end of the range given sort of your commentary this morning? And I have a quick follow-up.
Liam Kelly:
Yes. So David, obviously, we are very happy with the progress that we made in 2019. And we are a little bit like the Patriots. We had a much stronger second half than first half in our Teleflex year and in our Super Bowl if I can put it that way. So we have a lot of momentum as we get into just kind of 2019. And in 2019, we estimate that our organic constant currency revenue growth will accelerate in the 5.1% in ‘18 to the 6% to 7% in 2019. And I will point to a few of the growth drivers that we see that will get that acceleration. NeoTract will add approximately 30%, Interventional Access will deliver high single digits, APAC delivering mid- to upper single-digit growth. Those are the three main drivers to that. We also as well as that we expect continued growth in Vidacare. We expect our PICCs to continue to grow, OEM to continue and obviously a rebound in our surgical business and also in Latin America. So, we feel very comfortable with our range of the 6% to 7% and bridging from 5.1% to the 6%, we also feel pretty confident in that lower end, David.
David Lewis:
Okay. Just sort of to say, Liam that the contribution of incremental products, MANTA, Percuvance, RePlas, it can push you to the upper end of that range. And then my last follow-up I will just ask as well as you think about NeoTract, I wonder if Tom can give us a sense of where NeoTract gross margins sit prior to Neo 2 and then your 30% growth outlook for 2019, what assumptions were made there to reflect emerging competition? Thanks so much. I will jump back in queue.
Liam Kelly:
Okay. So obviously, it’s a competitive world across many of our businesses, David and the main competition for the UroLift product is the Rezum product. I will say that we are very much down the track of making Rezum or making UroLift the standard of care for the treatment of BPH. We believe that the clinical evidence that we had and the continued clinical evidence that continues to support the product makes it a very easy choice for the urologists to pick our product, the UroLift everyday. We continue to invest behind the sales organization, so for an example, just in sales investment, excluding all the other aspects that we spoke about, we’re actually investing about $10 million in additional sales resources behind the UroLift product. Our original plan for sales heads at this point in our original model was to be at about 85 sales heads. We’re crossing over the 100 mark as we continue to invest heavily behind it, and that’s why we remain confident even in the competitive world. And there is, also the rising boat lifts all tide the rising tide lifts all boats, when we have another company talking about BPH, we actually see that as being a potential good thing as more urologists become aware. And as you heard in my prepared remarks, a lot of men are not aware that there is a minimally invasive treatment out there that has minimal sexual dysfunction or zero sexual dysfunction. So therefore, by educating urologists, by having another company talking and educating urologists that will ultimately end up in men being educated and we still only scratch the surface of penetration with the UroLift product. Tom, do you want to cover the margin question that David asked?
Thomas Powell:
Yes, certainly. So, David, as we’ve seen volumes grow with NeoTract, we’ve also seen the ability to expand the gross margin even before we go UL2. So, in 2018, we finished the year, I would say, in the mid-70% gross margins. For 2019 we, expect to tick up a little bit further towards the upper mid, if you will, kind of the upper mid range of the 70s.
Operator:
Thank you. Our next question comes from Rich Newitter with SVB Leerink. Your line is open.
Rich Newitter:
Hi thanks for taking the questions. Just wanted to start off with the guidance, the 6% to 7%, I appreciate a lot of your growth drivers are now organic, but just tracking that underlying base business, I think, is important because that’s where we saw most of the fluctuations last year. Is it right to think kind of the ex NeoTract and VSI business as still a 4% growth business as you contemplate that 6% to 7% growth outlook?
Liam Kelly:
Yes, thanks, Rich. So, as we look at it, I mean, it’s all organic for Teleflex as we move into 2019. The way we look at it, we’re moving from a 5.1% growth to a 6% to 7% growth. It gets more and more difficult to break out VSI as it becomes embedded within Teleflex. VSI had an excellent year. And we will point even to look at the Interventional Access business unit that we will now be breaking out globally and we would expect that business unit to be in the high single digit for the year 2019. And as I said earlier, the other drivers of our growth that we expect is obviously NeoTract that we’ve spoken about, but also APAC, which we would expect to be in the mid- to upper single-digit growth. And as I said already, there are some other key product and regions such as Vidacare, PICCs, OEM, Surgical, and Latin America that we will expect to see improvements from. So, all in all, we feel very comfortable in our 6% to 7% organic constant currency revenue growth. And I think if we just take a step back, as a company, we couldn’t be happier to think that on as or even at a lower range, on an as-reported revenue growth of 5%, we’re getting double that in EPS, giving you 10% EPS growth, which is a pretty unique med tech asset in our mind.
Rich Newitter:
Okay, fair enough. And then, Liam, in the past, you’ve talked directionally to kind of what the tracing indicator kind of had been for the current and future quarter from your distributors. I guess, one, what percentage of your business is exposed even to maybe some of the factors that created lumpiness from the erratic distributor ordering patterns last year that has been a lesson this year to potentially limit the lumpiness? And then, two, what can you tell us if it’s still relevant about that tracing data in the current period? Thanks.
Liam Kelly:
Yes. So, starting with how much of our business is exposed, Rich, in the past, about half of our North American business went to the distributors, the Cardinals, the Owens & Minors, the Medlines, those distributors. Moving forward, now that NeoTract and VSI become organic and don’t normally go through that channel, about 1/3 of our business should go through those distributors. Regarding the tracings, our tracings were very consistent with the improved tracings that we saw in Q2 and Q3 of 2018. So, we continue to see good strong end customer demand for our products, which also makes us feel very confident about our 6% to 7% for 2019.
Rich Newitter:
Okay, thank you.
Operator:
Thank you. Our next question comes from Larry Keusch with Raymond James. Your line is open.
Larry Keusch:
Good morning everyone. Liam, I want to start with just one bigger-picture question, which is around the strength of your balance sheet as Tom indicated, 3.2x levered. Certainly, gives you, on our math, at least $1 billion of firepower for M&A. So, the question is, I think, most recently, you’ve been sort of talking about, again, a focus on de-leveraging but also potentially able to do some tuck-in M&A. I thought like the door was always opened a little bit more to a larger deal, and so I just wanted to take your temperature on how you’re thinking about M&A activity and potential size?
Liam Kelly:
Yes. So, you’re absolutely correct, Larry. We’re down to below 3 at the end of the year. Assuming we don’t do an M&A, we will continue to improve our leverage during 2019. The way I look at it, Larry, is that in 2019, we have the capacity to do a scaled transaction if we can find it. The next follow-up of the question normally, Larry, is what’s the environment like. So, the environment is pretty rich at the moment. We had a full M&A team at a big med tech conference recently that was held in San Francisco. We met with well over 60 companies at that. But we do realize, Larry, that we only get credit for the good transactions. So, having the capacity does not mean we’re actually going to do a transaction in ‘19, but we continue to be very active in the M&A world and we continue to look at assets on an ongoing basis. Even in 2018, we didn’t do any scaled transaction, but we still put nearly $100 million of capital to work between MANTA, go-direct and other smaller tuck-in transactions. But to answer your question directly, Larry, yes, we have the capacity to do a scaled transaction if we can find it in 2019.
Larry Keusch:
Okay, perfect. And then just two quick ones, looks like, at least, relative to my notes, that the timing of RePlas in terms of the BLA submission may have slipped a bit. It looks like now it’s 3Q, I had been under the impression it was more like end of 1Q, early 2Q, so any thoughts around that? And then secondly, maybe for Tom as, again, we think about the 1Q, just trying to think through sort of the comp issues associated with the flu and any thoughts you can provide us there?
Liam Kelly:
So, yes, I will begin with the RePlas question and you are correct, Larry. In our remarks, we said that the submission would be now in Q3 and you are also correct that we did expect it originally in Q2. And the delays is largely due to the government shutdown. Initially, we didn’t believe that the shutdown would have an impact as we’d already paid the fee. But ironically, given the fact that we’re on up fast-track process, the longer the shutdown went down, the less engagement we were able to get with the agency and that’s the primary reason for the delay. The fact that this was a new process for the FDA and for Teleflex required a lot more over-and-back communication with the agency and that simply didn’t happen as the shutdown went on a little bit longer than we anticipated and that’s what driven the delay, Larry. And Tom, the other part of the question?
Thomas Powell:
So, you’re asking about the comparability of this year versus last year on the flu, is that the question?
Larry Keusch:
Correct.
Thomas Powell:
Yes, we got off to a little bit slower start last year on the flu season or at the end of 2018, I should stay, but it now has moved into full swing flu season and we see a fairly comparable year-over-year comparison.
Larry Keusch:
Okay terrific. Thank you.
Operator:
Thank you. Our next question comes from Matthew Mishan with KeyBanc. Your line is open.
Matthew Mishan:
Hi good morning and thank you for taking the questions. Hi, Liam or Tom, you had mentioned headwinds from incremental tariffs. What is that assuming? Does it assume that tariffs go 25% on March 1?
Liam Kelly:
So, Tom, if you don’t mind?
Thomas Powell:
So, we actually assume that tariffs, yes, do increase, and in fact, increased in 2018 and this is a continuation of those tariffs through 2019. So essentially, we had previously spoken about the level of tariffs as we sat down and reassessed at year-end, we updated the expectation to a greater impact for 2019.
Matthew Mishan:
And the investment spending that you’re doing in growth areas, how long do you expect it to be elevated? And how should we think about the phasing of it over 2019?
Liam Kelly:
Yes. So, some of the investments we’re actually moving forward. So, we had in our LRP anticipated doing some investments within the Japanese market. It’s a good problem to have, quite frankly. We got the Shonin approval much earlier than we anticipated, so we’re actually moving that investment forward for NeoTract. The other investment behind NeoTract is really on the area of the direct-to-consumer campaigns that have been very, very successful in 2018. So, we want to continue those because they are an accelerator for top line growth. The cadence of the investment, they will begin from Q1 in 2019 and remain throughout the year.
Matthew Mishan:
Thank you.
Operator:
Thank you. Our next question comes from Matt Taylor with UBS. Your line is open.
Matt Taylor:
Hi good morning thanks for taking the question. So, I wanted to ask about MANTA, two things. First, with the early approval, I guess I was a little surprised that you’re not projecting any material revenue in 2019. Can you talk about why that is? And for the commercial infrastructure build, do you actually need to build a separate team or this going to leverage some of the cardio teams that you already have in place? And just why so long to actually see some uptake given the uptake you’ve had in Europe?
Liam Kelly:
Yes, thanks, Matt. So, first of all, I want to say we’re very pleased to receive the PMA approval in Q1. A panel review was not required. And as I mentioned, in my prepared remarks, we’ll now commence the limited market release in 2019. I think we’re taking a reasonably cautious approach to the launch. We need to recruit some additional clinical sales heads, but it will be sold through our Interventional sales force. And we are rolling out what has been incredibly successful for us in both our Vascular business unit in our Interventional Urology business unit with the UroLift and now this business unit, which is hunter/farmer model where we will utilize our experienced sales force to begin to convert the account and then we will roll out a clinical and a support function to continue the utilization of the product. We will begin in the 20 sites in the U.S. that were a part of the SAFE MANTA IDE clinical study, and that’s going to be our goal for Q2 and Q3. And maybe we’re just being a little bit conservative, Matt, in our expectations of the revenue, but we think at this stage, it’s better off to be conservative than aggressive until we see the traction of the product in the marketplace. We continue to be very excited about the product, and clinical data for the product is compelling with an over 70% reduction in major vascular complications. And this is significant but according to a JMAT 2017 study, these patients who require 5 additional days in a hospital are twice as likely to die. And the cost of the hospitals, on average, $18,000 as a result. And MANTA continues to have a 96% success rate in hemostasis and a median time to hemostasis reduced to 23 seconds from anything from 6 to 10 minutes. So, the clinical data is compelling. We’re very enthusiastic about the product. Don’t take our comments that we don’t have a lot of revenue baked in to think that we’re not very enthusiastic. I think this in time could be proven to be one of our nicer tuck-in acquisitions in a long time.
Matt Taylor:
Thank you. And then just one follow-up on UroLift, I was hoping you might be able to expound on what you mean by making it the standard of care over time. What do you need to do to get from where you are today to a standard of care? And what exactly do you mean by that? I think most people think of that as meaning first-line therapy. You’ve already had 5-year follow-up with a really robust PMA. So, do you need more evidence? Do you need more time? And how will it expand the opportunity when you get to that point?
Liam Kelly:
Yes, so I think that to make it a standard of care, we need to get an improvement on where we are today. So, let’s take a step back and look at your standard urologist. Your standard urologist will see 75 unique BPH patients every month. On average, the urologists we’ve trained are treating 4 of those patients every month. I think the headway for growth is still a long way and we’re very early in the penetration at this moment in time. So over time, we see getting deeper to that penetration and getting a larger portion of those 75 patients. And once we have a more significant portion, then it would become a front-line therapy and will become the standard of care. Again, Matt, we’re so early on the penetration. We’ve only just trained just over 1,900 urologists of the 12,000 urologists within the United States, so we see significant headroom for future growth. And when we have, let’s call it, 6,000 urologists trained, which are the ones that treat over 80% of the BPH patients, we will be further along the way of making it a standard of care. And once we get more of those 75 patients, it would also see us becoming the standard of care.
Matt Taylor:
Great. Thanks a lot.
Liam Kelly:
Sure. Thanks Matt.
Operator:
Thank you. Our next question comes from Brian Weinstein with William Blair. Your line is open.
Brian Weinstein:
Hi guys. Thanks for taking the question. Going back to question that was asked a little bit earlier, can you just I know you said this a bunch of different times, but can you just be a little bit more specific and quantify the impact from all the additional spending that you’re pulling forward here, I mean, there’s no I recognize that this was thought about in the long-range plan, but we’re seeing no leverage again from gross margin to operating margin similar to Q4. So, I just kind of want to understand ex some of these investments, kind of what’s the leverage from gross to operating margin might have been in 2019.
Liam Kelly:
So, I’ll start with the investments and I’ll let Tom then chime in with the leverage. So, in addition to investments just in UroLift and in MANTA, there is about $15 million of additional investments we’re making just in those 2 big buckets in all the areas we spoke about, Brian. On top of that, there’s a $10 million that we had originally contemplated in addition of sales heads that we’re putting in behind UroLift as we continue to drive the top line growth for that product. I’ve always said, not all growth ain’t free, so we’ve got to invest and continue to invest in clinical papers and so on and so forth in order to get there. I’ll let Tom answer the leverage question or the drop-through question if that investment wasn’t there.
Thomas Powell:
Sure, sure. So, as you know, our operating margin is currently expected to expand by 80 to 130 basis points. The investments that Liam just outlined being $15 million largely relates to the investment for UroLift in Japan as well as the development of the U.S. market for MANTA. If you were to back that out, that operating margin would go from 80 to 130 basis points to 135 to 185 basis points and that doesn’t factor in the point that Liam just made relative to the increase in the sales force for NeoTract. So, it would show a nice margin expansion. I think as Liam mentioned, we are pulling some of those investments forward. And as the businesses begin to grow, obviously we’ll offset that investment and continue to drive revenue and margin expansion.
Brian Weinstein:
Perfect. And then as a follow-up, you do have a couple of businesses that continue to be a little bit weaker than obviously corporate average, but Anesthesia, Surgical, in particular. Can you just talk about opportunities to start to potentially improve growth rates in those businesses they haven’t been covered as much on the call? Thanks.
Liam Kelly:
Absolutely, Brian. And I will start by saying that in Q4 actually, Surgical, even though it was negative, it was less negative than we had originally anticipated. If you recall on the Q3 earnings call, I mentioned that we expected to grow 8.6% in Q4 and we actually grew 9.1% in Q4. And one of the improvements within there was the Surgical business combined with Vascular OEM and Interventional Urology. But to answer your question regarding those 2 businesses, I think as we go into 2019, Surgical will no longer have that headwind of this business that we made the decision to exit. That could be more profound in the first half of the year versus the second half of the year. Our Anesthesia business grew by 2.1% in this quarter just gone and I think that our Anesthesia business has shown an improvement in 2018 over 2017. So, we continue to be we continue to believe that, that business shows improvement on a year-over-year basis, and actually on a full year basis, it grew by 3.6%, which is about right for a business in the space that it’s in. And don’t forget, Anesthesia is the business unit as we go into 2020 and 2021 where RePlas revenue will be recognized. So, well, that would be a driver for growth within the future. We continue to see growth in that business in our laryngoscope blades. We continue to work with our laryngeal mask portfolio and others. So, I think at 3.6% growth on an annual basis is about right for that business, Brian.
Brian Weinstein:
Okay thank you.
Operator:
Thank you. Our next question comes from Anthony Petrone with Jefferies. Your line is open.
Anthony Petrone:
Thanks. Good morning. I have a couple on UroLift and then one on restructuring. Just on UroLift, maybe Liam, the Japan opportunity, can you give a sense of how many urologists is sort of you’re targeting in that market and how pricing settled out there? And then a follow-up on UroLift would be when you look at Japan and UroLift 2 sort of in relation to the $325 million milestone in 2021, it seems like these 2 drivers will make that more achievable. Maybe just some thoughts around that, and then I have a follow-up for Tom? Thanks.
Liam Kelly:
Okay. So, we estimate that the total Japanese market is probably $2 billion. Initially, we will be targeting what the investment that we’re putting in is to target some of the key opinion leaders, podium-speaking opinion leaders that we will require in order to get the reimbursement. So, we will begin to get urologists to use the product in selected cases now that we have the approval so that they can then write to the authorities identifying this as a priority product and can take it as a priority product for them. Regarding the pricing, the pricing would be determined by the reimbursement. There are approximately 1,900 urologists in the United States trained urologists within the United States. So, the urologists within Japan, we will get that data as we start penetrating within the marketplace. I think that the pricing, as I said, will be determined by the reimbursement. We expect to get the reimbursement in 12 to 18 months after the Shonin. We think that the reimbursement would be quite similar to what we get within the United States, but that will be determined, Anthony, in the time we get that reimbursement. The work that we’re doing now in Japan is to ensure that the authorities realize what an important technology this is. There is a significant connection between the Japanese urology society and the U.S. urology society, which should have.
Anthony Petrone:
Helpful. And then just a follow-up there, Japan and UroLift 2 in relation to the $325 million milestone in 2021, it seems like this certainly makes that more probable a more probable target, maybe just some thoughts there?
Liam Kelly:
So, I would say, Anthony, even before this, I thought that was a very probable target. We always and I said it many times that we anticipate and expect a payout of that full milestone. Nothing has changed in my thinking. The revenues that will be generated in Japan will begin in the latter half of 2020 there. And so obviously, that will be ahead of our original call-out, and you are correct, that should help that milestone.
Anthony Petrone:
Thanks again. And then just restructuring for Tom, new one announced today with the release and maybe just to recap on this seems to be new and not related to the existing programs, but sort of when you wrap all of the programs up, where do you expect the total annualized cost savings to be once all of these are completed and sort of when do you expect that to happen? Thanks.
Thomas Powell:
Sure. Well, of the programs that are currently outstanding and operational and some of that that we have kicked off frankly have ran their course. But of those two outstanding, we expect total savings ranging from $122 million to $136 million once fully implemented. I would say that in terms of savings that are still remaining to be realized, that’s more in the range of $60 million to $70 million. The program that we launched this morning or initiated recently and announced this morning really is a program that won’t start to realize any savings until 2021 and 2022.
Liam Kelly:
And Anthony, I apologize, I didn’t answer your question directly. There are approximately 8,000 urologists in Japan.
Anthony Petrone:
Thank you. Thanks again.
Operator:
Thank you. Our next question comes from Isaac Ro with Goldman Sachs. Your line is open.
Isaac Ro:
Hi good morning guys thank you. Another question on UroLift. Specifically, if you could maybe give us a sense of the contribution that you expect from UroLift 2 in revenue this year given your comments around the timing and sales force ramp and I’m curious, on that comment, it seems like you said that the key swing factor, the pace of reps is going to be training for your sales force. Can you just talk a little bit about the key hurdles there? I would think that’s a pretty straightforward thing, that you have good line of sight on, but kind of curious as to whether there’s a reasonable range to think about of how quickly that could play out?
Liam Kelly:
So, the UroLift 2, we expect to roll that out in the latter half of 2019. There won’t be a revenue pickup from it because the pricing for UroLift 2 is the same as UroLift 1. So, we don’t anticipate to have a big but we wouldn’t get a margin pickup as we begin to roll it out. So, the real play here is to move from the mid-70s to the high 70s in gross margin as we roll out the UroLift 2 and we will begin in the latter half of 2019, this year. Just to answer your question on the training, the training was more one of the reasons that we snowballed the rollout the UroLift 2 was to allow our salespeople to train urologists on the median lobe, which was a new indication we got in 2018. So, we didn’t want to distract our sales force and take away from the growth engine by having them do 2 things at the one time, training on the median lobe and rolling out the UL 2. Now we should have the training on the median lobe completed with most of our urologists by halfway through 2019 and that would free up the resources to roll out the UL 2, as I said, in the latter half of ‘19. I hope that makes it clear.
Isaac Ro:
Yes, that makes sense. Thank you. And then just a follow-up on the restructuring program, maybe a little bit more of a longer-term question here. I’m wondering if some of the steps that you’re taking here could have benefit to the company for cash performance and maybe to the tax rate? It’d be helpful if you could maybe quantify the extent to which those might play out. Thanks.
Thomas Powell:
So, the real focus for us is to continue to drive earnings accretion and obviously that’ll play into cash flow as well. With the recent program that we’ve initiated, it’s expecting to deliver savings of $11 million to $14 million on top of the programs that were already outstanding. So, we would see this as a way to kind of solidify, if you will, our free cash flow. It’s not much of a tax play as it is in terms of driving cash flow savings.
Isaac Ro:
Got it. Thank you guys.
Operator:
Thank you. Our next question comes from Dave Turkaly with JMP Securities. Your line is open.
Dave Turkaly:
Thanks. I just want to make sure I heard that last part, the restructuring, right. So, $60 million to $70 million in pretax savings coming from prior programs, this one, $12 million to $14 million, I just want to confirm that. And then if that’s the case, you’ve talked about your long-term gross margin plan. It would seem that getting north of $60 million would already you could already sort of have identified or put yourself in that range with the program you’ve announced that you technically wouldn’t need any other new ones. But just, I guess, your thoughts on that.
Thomas Powell:
Well, I think the point you’re making is a valid one. We have good line of sight to our gross margin target of $60 million to $61 million. We’re guiding to within pretty close range of that for this year and that includes the impact of the tariffs. Our hope is that perhaps those tariffs aren’t in place in the future and that can provide another benefit. But yes, we do have very clear line of sight with the activities currently in place to get to that gross margin target.
Liam Kelly:
I’ll just point out, Dave, that, that is true. Not all the restructuring programs will be completed by 2021.
Thomas Powell:
That’s a fair point.
Dave Turkaly:
Got it. And then manufacturing footprint realignment, over the years, we have seen several of those. I imagine that you may not have as many opportunities to announce more along in that exact bucket or that category. I guess, just any comment on the footprint? And are there still opportunities to consolidate manufacturing facilities?
Liam Kelly:
So, David, it’s Liam here, we continue to look for always look at our business right across, not only in manufacturing, but in all areas of our business as part of our ongoing process. And the interesting thing about restructuring is and manufacturing alignment is that every time we do a scaled acquisition, there is the potential to identify more opportunities. So it’s a little bit like dealer to direct. We think we are well down the road with our dealer to direct than we do in acquisition like VSI and it identifies other opportunities and we saw that in 2017. So, it’s an ongoing process and it’s something we look at on a fairly regular basis.
Dave Turkaly:
Thanks.
Operator:
Thank you. Our next question comes from Kristen Stewart with Barclays. Your line is open.
Kristen Stewart:
Hey, good morning everybody. Thanks for letting me take a question. If I am doing the math right, if I look at the incremental sales from NeoTract this quarter as well as the incremental sales from VSI this quarter, which were really quite strong, it looks like combined those two products basically contributed a little over 5 percentage points to the top line, which would imply I guess the legacy business was flat? Am I thinking about that correctly in doing the math?
Liam Kelly:
So our growth within the quarter, our constant currency growth was 9.1%. Our growth in – it was 9.4% into the M&A. When we bridged, we bridged to 3.7% with our run-rate through Q3 and we said UroLift would add 3%, [indiscernible] would add 1.3% and the improvement will be 60 basis points, I think. If you look at what actually happened, UroLift just did modestly better, but the core business actually, the 60 basis points of improvement was better and did better than that 60 basis points improvement. And Kristen, it gets to the point where trying to exact VSI from the core becomes more and more difficult when we go through it. So I don’t want people to think that we’re going to continue to talk about our business in core or non-core, because there is a few moving pieces. You also have the fact that we exited a business in 2018 that had an impact. But our core was very much in line with our expectations within that quarter. And we had a really strong second half of the year with our overall business, and I think we’re in great spot to line up to do our 6% to 7% in 2019.
Kristen Stewart:
Okay. And then just thinking about the pricing dynamics for this year, I think you guys ended up with 70 basis points of favorable price. I believe that includes the benefit of distributor conversion. Should we think about the components of growth next year maybe less relying on that effect of distributor conversion? Do you have still more to go or will the growth kind of still come more from new products?
Liam Kelly:
Sorry. Go ahead, Kristen. I didn’t mean to talk sorry. So I guess, basically you are correct, most of the – almost all of that pricing came from our go direct. So our pricing in 2018 in core pricing was neutral and you could expect the same in 2019, very neutral pricing overall and we don’t anticipate or we haven’t been seeing any go direct or significant go direct in 2019.
Kristen Stewart:
Thank you very much.
Liam Kelly:
Yes, I would expect to answer your question on the core business, the core business was approximately 3.7% in the second half of ‘18 just to reinforce my point on the improvement in the core business as we went through the year.
Kristen Stewart:
Okay. I will take that offline.
Operator:
Thank you. Our next question comes from Mike Matson with Needham. Your line is open.
Mike Matson:
Hi, thanks for squeezing me in. I guess just wanted to go back to UroLift in Japan, can you just talk about the market there for treating BPH, is it similar to the U.S., in other words, are there same types of laser products there and etcetera? Thanks.
Liam Kelly:
Yes, Mike, it’s the second largest medical device market in the world outside the U.S. and they are very, very developed. So they would have all the technologies that we would have in the United States. They use similar therapies. They actually do more surgeries than we traditionally do within the United States and the other anomaly within the Japanese culture, which I think will help us, is that the whole area of sexual dysfunction is probably more highlighted than it would be in a Western culture. So I think that, that will be something that we will be promoting with our urology partners and the urologists in Japan because men can stay sexually active much later in life than they traditionally do in the Western world.
Mike Matson:
Okay, thanks. And then just with the RePlas being pushed off by a quarter, you mentioned this post-approval efficacy trial and other things you have to do before you can really get in to kind of a full launch, because that implied that there is really no – you are not expecting any meaningful revenue from that this year. And then once you start selling it particularly to the military is this going to be kind of like a fairly lumpy where they come in and just order a bunch or is it going to be more of a kind of a gradual ramp in the sales? Thanks.
Liam Kelly:
Yes, Mike, you are correct we don’t have revenue expectation for RePlas in 2019. The post-market study will not prohibit us from selling the products. The FDA just mandated that we do that study post-launch or we will still be in a launch phase. Regarding your question on the military and the lumpiness of it, we do not expect the military to come in and place one blanket order. We expect this to be a gradual adoption of this technology. We believe that they will begin in the Special Forces within [indiscernible] there is always some activity and this product has incredible relevance in the back of the field where soldiers would require plasma and the current plasma offerings are not applicable in that type of an environment, because you either need to follow them ordering last year. So I would believe we would see a modest pickup beginning there and then ramp. Then once it’s established, it can be somewhat lumpy, to your expression, because they will fill out the kit bags. Now we will try to manage the timing of that so they’re not filling out the kickbacks for the Air Force, the Navy, the Marines and the military all in the one time. So that should help smooth it out. So we have a reasonable amount of our EZ-IO Vidacare business that currently goes through the military and we have a good call point into that area of business.
Mike Matson:
Okay, great. Thank you.
Operator:
Thank you. [Operator Instructions] Our next question is a follow-up from Larry Keusch with Raymond James. Your line is open.
Larry Keusch:
Okay, thanks. Just two quick ones guys. Just on the APAC region, so growth was 5.5% constant currency in the fourth quarter, 6.7% in the third quarter. We have obviously now anniversaried the go direct over there in China. So just wanted to get some sense of what’s sort of the right way to think about the growth and I recognize that UroLift at some point will influence that? But prior to that launch, what’s the right way to think about APAC and where can that go? And then the other quick question was just on the free cash flow, if I remember correctly, Tom, I think you guys are looking for $1.5 billion in free cash flow generation over the course of the LRP and just wanted to see how you are thinking about that as we come out of 2018?
Liam Kelly:
Okay, Larry, I will take APAC first. So APAC, you are right, grew quarter four, 5.5%. It actually grew by 6.6% on a year basis in 2018. What I expect from APAC in ‘19 and in the longer horizon is that it will grow in the mid to upper single-digits. We continue to have momentum as we have gone through the year. China grew by I think 5.2% in the fourth quarter, but it was up against a really tough comparator. It was almost 10.5%, 11% in the prior Q4. We have anniversaried the go-direct and we continue to build momentum in China. But along with that, we will then register the UroLift in other geographies. We have identified three geographies within APAC that we are working to register the UroLift product and that’s above and beyond the Shonin that we received for Japan. We are also rolling out some initiatives around clinical education in different geographies within Asia-Pac and we believe that will be an accelerator as well. So we feel, I mean, China – our Japan – our Asia-Pac is one of our key drivers with Interventional Access and with Interventional Urology. And again, it goes back to the old Teleflex philosophy, not all growth is equal. Those three areas of growth are all accretive to our longer term gross margin objectives. Then free cash flow?
Thomas Powell:
Sure. So Larry, just on the free cash flow, to your point, yes, we had guided to approximately $1.5 billion of free cash flow over the timeframe 2019 to 2021 and we are still on track towards that from an operating standpoint. I will say there are two kind of non-operating impacts that have come up since then. One is that the performance from the acquisitions is outperforming the initial accounting estimates if you will and so the extent we pay out more in contingent consideration such as the prior discussion we had on NeoTract that would impact free cash flow as a reduction in cash flow from operations. Additionally, the restructuring program that we just announced was not contemplated in that guidance, but that isn’t all that meaningful from a longer term. But if you were to adjust for the contingent consideration payments, yes, we are still on track for that $1.5 billion free cash flow target.
Larry Keusch:
Okay, terrific. Thank you.
Thomas Powell:
Yes.
Operator:
Thank you. Our next question is a follow-up from Kristen Stewart with Barclays. Your line is open.
Kristen Stewart:
Hey, thanks for taking the follow-up. Just real quickly, I think that you guys – well, I heard you guys reiterate the long range plan. I am just wondering if the restructuring programs that you announced today, which said they start realizing savings in 2021, which I would assume are pretty small how that just kind of plays into your confidence and the operating margin performance maybe getting to the lower end or the higher end just given some of the pacings of the investments as well that you are making in the business? And then also the tax rate, that came in a little bit below where I was anticipating this year how do you still feel about the longer term tax guidance that’s out there?
Thomas Powell:
Sure. So as we just think about the tax rate, I think we are still of the expectation that the tax rate will continue to move upwards in subsequent years. That’s largely due to a shift in mix where we are expecting more and more income to be generated in the U.S. And that tax rate, although reduced in the recent Tax Cuts and Jobs Act, is still higher than our average. Now the drivers of that increase in the U.S. income is businesses such as the UroLift products as well as catheter solutions that are growing have above average margins and the growth is predominantly in the U.S. So we do still expect the tax rate to move up as time progresses. I will say that our assessment of the Tax Cuts and Jobs Act has been a little bit more favorable than our initial interpretation of the act and so we are seeing a little bit of favorability from that. So I would say the two of them fairly well wash out over the longer term, so I would right now assume the tax rate is still moving in line with the longer term projection. And then the first focus area maybe just help refine the...
Liam Kelly:
The 2020 restructuring program, so I think the inputs are the – this restructuring program has a modest impact in 2021, Kristen. So that’s going to – it’s going to be beyond that where we will see the benefit of this new restructuring program.
Kristen Stewart:
Okay. So it’s not like there should be any significant level of upside or greater confidence in the higher end of the operating margin LRP just given that it’s going to be more modest?
Liam Kelly:
I think as Tom said, the upside on the LRP is going to come from improvement in mix more so than coming from this latest restructuring program. I think we continue to be very bullish about things like UroLift, very bullish about VSI, very bullish about MANTA, very bullish about RePlas and very bullish about Asia Pacific and Vidacare. And all of those, if they perform better, will deliver significant mix that could be a potential for upside in our LRP on the gross and operating margin.
Thomas Powell:
Yes. And just to think about the kind of the cadence of those savings, I had mentioned that of the $122 million to $136 million in total program savings and just to clarify that is inclusive of the program just announced today. So of that savings, about $60 million to $70 million is still outstanding. And through the timeframe 2021, we expect to realize about half of that $60 million to $70 million. So as you can see, we are creating some benefit to extend beyond the LRP timeframe.
Kristen Stewart:
Okay, perfect. Thanks very much guys.
Thomas Powell:
Thank you.
Operator:
Thank you. I am showing no further questions at this time. I’d like to turn the call back over to Jake Elguicze for closing remarks.
Jake Elguicze:
Thanks, operator and thank you everyone for joining us on the call today. This concludes the Teleflex Incorporated fourth quarter 2018 earnings conference call.
Operator:
Ladies and gentlemen, this concludes today’s conference. Thanks for your participation. Have a wonderful day.
Executives:
Jake Elguicze - Teleflex, Inc. Liam J. Kelly - Teleflex, Inc. Thomas E. Powell - Teleflex, Inc.
Analysts:
David Ryan Lewis - Morgan Stanley & Co. LLC Richard Newitter - Leerink Partners LLC Lawrence Keusch - Raymond James & Associates, Inc. Anthony Petrone - Jefferies LLC Mike Matson - Needham & Co. LLC Matthew O'Brien - Piper Jaffray & Co. Brian David Weinstein - William Blair & Co. LLC David Turkaly - JMP Securities LLC Isaac Ro - Goldman Sachs & Co. LLC Kristen Stewart - Barclays Investment Bank
Operator:
Good day, ladies and gentlemen, and welcome to the Third Quarter 2018 Teleflex Incorporated Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Mr. Jake Elguicze, Treasurer and Vice President of Investor Relations. Please go ahead.
Jake Elguicze - Teleflex, Inc.:
Good morning, everyone, and welcome to the Teleflex Incorporated third quarter 2018 earnings conference call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing 855-859-2056 or, for International calls, 404-537-3406; passcode 8158978. Participating on today's call are Liam Kelly, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks and then we'll open up the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are in fact forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K which can be accessed on our website. With that, I'd like to now turn the call over to Liam.
Liam J. Kelly - Teleflex, Inc.:
Thank you, Jake, and good morning, everyone. It's a pleasure to speak with you again to discuss our third quarter financial results. Before we get into the details, I would like to say that we are very happy with our results this quarter and not simply because of the rebound in our organic constant currency revenue growth performance. In addition to good top line performance during the quarter
Thomas E. Powell - Teleflex, Inc.:
Thanks, Liam, and good morning, everyone. Given the previous discussion of the company's revenue performance, I'll begin at the gross profit line. For the quarter, adjusted gross profit was $347.3 million versus $298 million in the prior year quarter or an increase of 16.6%. Adjusted gross margin increased 130 basis points versus the prior year to 57%. The expansion in adjusted gross margin reflects the planned impact of the acquisition of NeoTract and Vascular Solutions, efficiencies related to footprint consolidation programs and favorable pricing. However, the increase in gross margin was partially offset by unfavorable product mix and higher manufacturing costs. For the quarter, adjusted operating profit was $158.7 million versus $140.8 million in the prior quarter, or an increase of 12.7%. Adjusted operating margin was 26%, a decrease of 30 basis points from the prior year. The decrease was related to a tough prior year comparable, the shortfall in gross margin and increased levels of R&D investment. On a sequential basis, the third quarter adjusted operating margin of 26% was flat to the second quarter result of 26%. Moving down with P&L. Adjusted net interest expense increased to $26.9 million from $20.9 million in the prior year quarter. The increase reflects the impact of additional borrowings required to finance the acquisitions of Vascular Solutions and NeoTract. For the quarter, the adjusted tax rate was 10.7% versus 18.1% in the prior year period. The year-over-year decline reflects the impact of the recently enacted Tax Cuts and Jobs Act and a larger tax windfall benefit this year versus last year. On the bottom line, adjusted earnings per share increased 18.9% to $2.52. Turning now to select balance sheet and cash flow highlights. Through the first nine months of the year, cash flow from operations totaled $302.9 million, down approximately 5% over the prior year. The decrease was primarily due to unfavorable working capital changes partially offset by favorable operating results. The change in working capital is largely attributable to the factoring of Italian receivables in 2017, which did not reoccur in 2018, and increased 2018 tax payments. Finally, during the quarter, we repaid $80 million of debt and our leverage levels as defined in our credit facility stood at 3.18 times. Next, I'll briefly cover our recently completed cross-currency swap transaction. On October 4, we executed cross-currency swaps to hedge the variability of exchange rate impacts between the U.S. dollar and the euro. Due to the swap, we notionally exchanged $500 million at an interest rate of 4.625% or the euro equivalent of €433.9 million at an interest rate of 1.942%. These swaps are designated as net investment hedges and expire on October 4, 2023. Given the differential coupons and assuming a euro to dollar exchange rate of approximately $1.15, we estimate an interest benefit of approximately $3 million in 2018 and $13 million on an annual basis. We anticipate this benefit will help to mitigate the interest expense impact of a rising interest rate environment on our variable rate debt. And that completes my comments on the third quarter. Now, I'll move to an update on 2018 guidance. For revenue guidance, the only change we are making is to account for foreign exchange. Specifically, we now expect a full year favorable impact of 150 basis points compared to an expectation for 200 basis point impact in our prior year guidance. We are reaffirming our full year constant currency revenue growth guidance range of between 12% and 13%. We continue to expect that our organic revenue growth will be between 5% and 5.5%, although, as Liam mentioned earlier, we expect to be at the low-end of that range. We also expect constant currency revenue growth driven by M&A to be between 7% and 7.5%, but expect to be at the high end of that range. Because of a less favorable currency environment since we last provided guidance, most notably the euro and the Chinese yuan, we are adjusting our as-reported revenue growth guidance from a range of between 14% and 15% to a range of between 13.5% and 14.5%. Moving to margins, to reflect year-to-date performance trends and our expectation for the fourth quarter, we have lowered our previously provided adjusted gross margin guidance range of between 57.5% and 58% to a revised range of between 57% and 57.25%. The gross margin adjustment is attributed to unfavorable product mix, including better-than-expected performance from our OEM business which carries a lower gross margin profile, modest dilution from recently announced acquisitions, tariffs related to our business in China, and higher expenses to address the NeoTract production and engineering issues. We expect to offset approximately one-half of the gross margin impact through SG&A expense control and, thereby, partially mitigating the impact to operating margin. As a result, we are reducing our adjusted operating margin guidance to a range of between 25.8% and 26.1% from the previous range of between 26.1% and 26.5%. Turning now to interest expense; we currently anticipate approximately $104 million in interest expense during 2018. The reduction from our prior expectation of $109 million is primarily the result of the recently completed cross-currency swaps and an accelerated reduction of debt outstanding. Turning to taxes. We now expect our full year 2018 adjusted tax rate to be approximately 12.5% to 13%. This compares to our prior guidance which called for an adjusted tax rate of approximately 14.5%. On the bottom line, we are raising our outlook for 2018 adjusted earnings per share from a range of between $9.70 and $9.90 to a range of between $9.80 and $9.95. The $0.075 increase in the midpoint of our adjusted earnings per share range is primarily due to our over-performance in the third quarter as compared to our prior expectations. And so, in closing, third quarter delivered solid constant currency and organic revenue growth, and we are very pleased with the outcome. We're also pleased with third quarter adjusted EPS growth of 18.9%, year-to-date adjusted EPS growth of 19.8%, and the actions put in place to allow us to again raise our full year adjusted EPS guidance. We are disappointed by the need to adjust down 2018 margin guidance. However, I would like to point out that the midpoint of our revised adjusted gross margin guidance still represents a year-over-year increase of 130 basis points. Additionally, many of the cited issues are transitory in nature and the key drivers of our multi-year margin expansion plan remain intact. We continue to expect that NeoTract, Vascular Solutions and Vidacare will be major contributors to the margin expansion story because of their higher margin, higher growth profiles. We grow more confident in NeoTract as the business continues to exceed revenue and growth and profitability expectations. Additionally, with the recent acquisition of Essential Medical, we now add another business with high margin, high growth potential into the portfolio. The ongoing manufacturing footprint consolidation initiatives remain on track to deliver planned savings, and we have stepped up efforts to identify additional productivity opportunities within our manufacturing sites. The multi-year financial plan outlined earlier this year at Analyst Day contemplated only modest contribution from new products such as RePlas and Percuvance. Recent clinical and regulatory developments provide encouragement that such products may contribute above previously projected levels. Additionally, our multi-year guidance did not consider future acquisitions such as Essential Medical. In summary, we continue to focus our efforts and invest for sustainable top line and bottom line growth, and we remain enthusiastic regarding business prospects for the coming years. And that concludes my prepared remarks. Now, I'd like to turn the call back over to the operator for Q&A.
Operator:
Thank you. Our first question is from David Lewis with Morgan Stanley. Your line is open.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Good morning. Thanks for taking the questions. I thought you – very solid quarter, I thought that we'd think about next year a little bit here. So, two questions for Liam and Tom and then I had a quick follow-up. So, on growth, Liam, for you, organic revenue growth guidance for the fourth quarter implies 8% to 9% organic. You talked about your LRP this call being 6% to 7%. So, is the right way to think about next year something between the midpoint of these ranges, 6.5% to 7.5%? And then, for Tom, I wonder if you could help us with some of the more volatile components of next year on earnings; FX, tariffs, tax, the impact of the debt swap. How do these net out in your mind and how are you feeling about the profile for earnings next year relative to 2018? And I have one quick follow-up for Liam.
Liam J. Kelly - Teleflex, Inc.:
Hey, David. Thank you. So, regarding 2019 guidance, obviously, we'll provide that in February, not on this call. But you're right in your expectation of our fourth quarter growth. And as we outlined in the call, if you look at, through three quarters, our core organic growth was 3.7%. UroLift rolls off M&A in the fourth quarter; that will add 3%. And the additional day will add about 1.3%. So, in my mind, that's simply math that gets us to that increased performance in the fourth quarter. And then, we have a general improvement in our underlying business based on what we saw within the third quarter and that should add about 60 basis points. And again, we were able to reaffirm our full year constant currency guidance at 12% to 13% and the only adjustment we made, quite frankly, is for currency which is beyond our control. And then I'll let Tom answer the second part of your question.
Thomas E. Powell - Teleflex, Inc.:
Okay. Well, with regard to some of the more volatile components, as we think about some of the issues you outlined, tariffs for next year, we estimate currently to be about a $3 million full year impact. So certainly an impact but nothing that's insurmountable. In terms of the tax rate, this year, we are benefiting from a very improved tax rate versus prior year largely due to two factors. The first is the Tax Cuts and Jobs Act and we expect for that benefit to continue into next year. The other is due to stock-based comp windfall benefit. And that, as you can imagine, is less predictable if somewhat dependent upon how people choose to exercise equity and how some of the restricted shares vest. So, to be able to predict that right now would be difficult. We could have some better visibility as we get closer to the year. On the tax front, there are a couple of things also that will cause the rate to perhaps have some upward pressure. The first is just the implementation of the swap and that will reduce our interest deduction and put some upward pressure. In addition, our mix has typically been skewing a little bit more North America based. And in fact, with the growth of Vascular Solutions and NeoTract, we expect that to continue. But, overall, we expect our tax rate next year to be below where it was back in 2017. I'm not sure if it's going to get to the level we're seeing this year. What other...?
David Ryan Lewis - Morgan Stanley & Co. LLC:
Currency. Currency, Tom?
Thomas E. Powell - Teleflex, Inc.:
Well, currency is fairly a headwind right now. I think the average for the year is probably going to end up somewhere around $1.17 to $1.18 relative to – that's on the euro – relative to where it's currently trading, which is more in the $1.14 range. So that could be a slight headwind for us as we get into the year. But we'd have to see how the whole basket of other currencies are trending at year-end. So, certainly, there's some volatility as a result of FX movements this year; seems to have stabilized a little bit right now in kind of the $1.14 range.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Okay. And then, Liam, just a follow-up here on the pipeline; a couple of interesting updates, obviously, this quarter and talking more of the MANTA Device, obviously, Percuvance approval was nice and the RePlas data. So, first question is on Percuvance, the opportunity you described for that business several years ago, do you still see that as the most appropriate opportunity for the size of that market? And how do we think about the contribution of some of these products next year in terms of their ability to get the full commercial launch, Percuvance, MANTA, obviously, RePlas is probably not a major factor. But how should we be thinking about the contribution for MANTA and Percuvance next year? Thanks so much.
Liam J. Kelly - Teleflex, Inc.:
Yeah. Sure. So, we're at the early – I'll start with MANTA, David. So, we are currently going through PMA approval for the key North American market and that's really goose that has the potential to lay the golden egg if I can put it that way. It's the biggest market for large bore closure. I would be very hopeful that by the time we get to 2019 guidance, that we would have very clear visibility on our PMA process and approval. If we do need a panel review, we could have approval in the first half of the year. If we don't need a panel review – sorry – if we don't need a panel review, it would be in the first half of the year; if we do, it will be in the latter half of the year. And we'll know that for sure, I think, by February. Regarding Percuvance, I still think the market potential for this is in that $300 million range globally. The sales team are very excited to get the product back into their hands. We're doing a limited market release late in Q4 now that we've gotten the approval, and we will start to roll the product out during 2019. We want to assess the pent-up demand that was there and the momentum that we had built up when we removed the product from the marketplace, and at that time then we'll give a much clearer assessment as to what we expect in 2019, 2020 and 2021. But, clearly, it's a great starting point to get the 510(k). We're very excited about MANTA. We think that will address a $200 million to $300 million market opportunity as I said in my prepared remarks, and that's looking at TEVAR and EVAR closure procedures. And we firmly believe that we will be first to market with this product. This product is interesting because we've been talking to this company for four years, and as an organization, we had a decision whether to make or buy this. We were working on an internal development ourselves, and we decided that it's very complex to get a large bore closure device that works. And it's very hard to get a large bore device that works yet venous stasis (39:17). And one of the added complications when you're in the cath lab is that you won't bring in the next patient until you're sure your hemostasis on the one that's on the table. So we believe, and we got to prove this out with clinical data, but we believe we can make the cath labs more efficient and some of the anecdotal evidence we got from the Netherlands would tell us that they're getting an additional procedure through the cath lab as a result of using the MANTA large bore closure device.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Great. Thanks so much, Liam. Nice quarter.
Liam J. Kelly - Teleflex, Inc.:
Thanks, David.
Operator:
Thank you. Our next question is from Richard Newitter with Leerink Partners. Your line is open.
Richard Newitter - Leerink Partners LLC:
Hi. Thanks for taking the questions and nice job on accelerating organic growth this quarter.
Liam J. Kelly - Teleflex, Inc.:
Thanks, Rich.
Richard Newitter - Leerink Partners LLC:
I wanted to ask a quick question on the OEM accounting changes. What was the contribution from that to organic growth? Was it contemplated in your original guidance plan and can you talk about what kind of contribution that might have to 2019?
Liam J. Kelly - Teleflex, Inc.:
Yeah. So, it was contemplated within our guidance, Rich. And OEM had an excellent performance from a volume perspective as well as some benefit from the new rev rec rules. In any quarter, there are revenue puts and takes, and if I take them all into account, the puts and the takes including the OEM, we probably had a net positive of around 20 basis points net-net. So, the OEM gave us a positive. We didn't fully get through the disruption in the supply chain. And the total impact within the quarter of the OEM, to answer your question directly, was about $3 million, Rich.
Richard Newitter - Leerink Partners LLC:
Okay, got it. So, by my math, you still would've been above 5% backing that out, right?
Liam J. Kelly - Teleflex, Inc.:
Absolutely. And if you – Rich, there's always puts and takes, as I said. So, if I take all the puts and all the takes, and if I take the $3 million positive from that, we didn't fully get through all of our supply disruptions. There's about $1 million there. We got over $3 million, as I said, on the second quarter from distributor orders, most of it stuck – about $2.2 million of it stuck. So, you add it all up, it's about a 20-basis point impact.
Richard Newitter - Leerink Partners LLC:
Got it. And then just as we think of the kind of the puts and takes around gross margin as we head into next year, I appreciate you're not giving guidance, but it sounds like some of the items are beyond currency. Just could you give us a sense for how we should be thinking about gross margin directionally relative to 2018? There still should clearly be upward bias even when you net out all the puts and the takes. Is that a fair assumption?
Liam J. Kelly - Teleflex, Inc.:
So, as Tom said – and I'll throw it to Tom, but I'll just make an opening. As Tom said in his comments, most of these were transitory in nature and our long term margin guidance, as we said, were ratable, and I think that nothing has changed in our restructuring programs, nothing has changed in the acceleration of mix coming from NeoTract and VSI. As you can see, their performance is exceptional. But I'd get Tom go into more of the details I think.
Thomas E. Powell - Teleflex, Inc.:
Yeah. That's exactly it. So, as we looked at the items that impacted 2018, the majority of them are transitory. I would say that the tariffs will be one that are sticky. We quantified that currently at $3 million, but again, that's not something that will throw us off our longer-term track. As we look at that long-term margin expansion, it's really predicated on a couple of key things. One are the restructuring programs that we put in place, and those programs are still right on track and delivering as expected. It's also a margin expansion story based on some of our key product offerings such as NeoTract, Vascular Solutions, and even Vidacare. And as we look at those businesses, we remain very, very confident in their performance and, in fact, pretty excited by some of the performance we've seen recently with NeoTract beating expectations and Vascular Solutions putting up double-digit growth consecutive quarters in a row. So we're excited by the margin drivers from both a revenue and a cost standpoint. So, you should expect to see continued expansion next year and to the coming years.
Richard Newitter - Leerink Partners LLC:
Got it. And maybe just one last one, I just want to be clear, so when – this quarter, in the third quarter, when you back out kind of all of the inorganic items, the actual kind of true organic growth even ex-Vascular Solutions which is organic, but even if you back out that contribution, the growth was somewhere in the 3.3% to 3.5% range, is that correct?
Liam J. Kelly - Teleflex, Inc.:
So our organic growth rate was 5.6% and that includes about 1% from VSI. So, therefore, we're at 4.6% on a true organic basis for our core business within the quarter.
Thomas E. Powell - Teleflex, Inc.:
And there's about, call it, 80 basis points of taking Vascular Solutions direct from a pricing standpoint that's included then in the organic number.
Liam J. Kelly - Teleflex, Inc.:
Yeah.
Richard Newitter - Leerink Partners LLC:
Okay. That's really helpful. Thanks, guys.
Operator:
Thank you. Our next question is from Larry Keusch with Raymond James. Your line is open.
Lawrence Keusch - Raymond James & Associates, Inc.:
Yeah. Hi. Good morning. I wanted to come back and touch on the core business, Liam, and really sort of understand how you guys are thinking about managing that business. There's obviously been a lot of focus on whether that business can grow 4%, maybe it's more like 3% to 4%, but I'm really curious as to just, again, are you really trying to optimize the growth there or is 3% to 4% good enough and really the resources are really focusing on the growth drivers?
Liam J. Kelly - Teleflex, Inc.:
Yeah. Well, we have this philosophy, Larry, as you know within Teleflex that not all growth is equal. If you look at where we're trying to grow our business, we're trying to grow our business in NeoTract, within our Interventional Access, within Asia-Pacific, within our Vascular business and within our Anesthesia business, and now within MANTA. All of these businesses have one thing in common
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Perfect. And then two other ones. Just on UroLift, what has to happen to push that really into sort of more of a frontline therapy position in the U.S.?
Liam J. Kelly - Teleflex, Inc.:
Front line? Just repeat the last part, Larry. I'm sorry.
Lawrence Keusch - Raymond James & Associates, Inc.:
Yeah. In the U.S., again, what has to happen or what could drive that device, that therapy into more of a first choice for a patient coming in with BPH symptoms versus medical therapy first and then moving into something like this?
Liam J. Kelly - Teleflex, Inc.:
So, we think we're very close, Larry, to having this as the first line of care. All the clinical data shows that the real life experience is very close to L.I.F.T data, and that's very important, number one. The clinical outcomes data is very, very compelling. The urinary retention that I mentioned is an important one because, previously, those men would wear a catheter for the remainder of their life; by using UroLift, now 90% of them don't wear a catheter. We also need to get greater penetration within the urologists. We're still very early in the penetration rate of urologists. There's 12,000 urologists within the United States and we have a long way to go to penetrate those urologists. Once we have all of those trained, it will become the standard of care and the key number of urologists, those are less than 6,000 that treat 80% of BPH patients. But we're going to continue, Larry, to go deep rather than wide to ensure this product is sticky and that it does become the standard of care for the treatment of BPH.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Perfect. And then last one just because you mentioned it. PICCs, maybe update us on the growth rate there. And remind me again, if you are in China or not and, again, what do you see the growth drivers for PICCs?
Liam J. Kelly - Teleflex, Inc.:
So our PICC growth was around 18% for the quarter, Larry, and we're really encouraged by that. We do not have our coated PICC yet registered within China. We're working on it. We have the clinical study underway to support our submission. And we're looking forward to having that product on the market in the next – once we get clinical study done, thereafter, the submission should take 12 to 18 months, but we continue to take share within the key North American market, and it is because of our antimicrobial and antithrombogenic coating technology that reduces infections for the hospitals. And now that they have to report them, they're very keen to adopt our technology.
Lawrence Keusch - Raymond James & Associates, Inc.:
Great. Thanks very much and very nice quarter.
Liam J. Kelly - Teleflex, Inc.:
Thanks, Larry.
Operator:
Thank you. Our next question is from Raj Denhoy with Jefferies. Your line is open.
Anthony Petrone - Jefferies LLC:
Thank you, guys. This is Anthony in for Raj. Actually just a question, Liam, can you repeat for the fourth quarter the moving parts on days to organic growth? And then I'll have a few follow-ups on UroLift. Thanks.
Liam J. Kelly - Teleflex, Inc.:
Yeah. So, in the fourth quarter, we have one additional day, Anthony, and that should add about 1.3%. And as I said earlier, that's simply a math problem having that additional day. And 2019 will have the same number of days as we had within 2018. And then, obviously, UroLift rolls into organic, that should add 3% within the quarter. And general business improvement continuing as we've seen in quarter three should be the last pillar to get us to our full year guidance range.
Anthony Petrone - Jefferies LLC:
And then just on UroLift, can you remind us a little bit on new physicians versus existing physicians, where your penetration is today more particularly on the latte, in existing physicians, and sort of where do you think that can go over the next two years?
Liam J. Kelly - Teleflex, Inc.:
Yeah. So, our existing – I'll first start with how many we've trained. So we've trained over 1,700 of the 12,000 urologists in North America. Regarding the utilization within physicians, our average physician that we trained is doing an average of about four procedures a month. Our highest adopting physicians are up into the teens with their adoption rate with some of them even going beyond the teen numbers. So we believe that's a nice move forward. So 97% of our revenues are coming from the existing physicians and we continue – and that's because of our strategy to continue to go deep rather than go wide. And again, Anthony, it's about utilization and we continue to see that utilization rate improve as we go deeper within these physician practices.
Anthony Petrone - Jefferies LLC:
And then a follow-up there would just be the landscape is heightened a little bit. You have Rezūm out there, UroLift list is out there; those are the two newest solutions. I'm just wondering is the market segmenting with these two solutions or are they going after sort of the same sort of patient sort of profiles. Thanks again. Good quarter.
Liam J. Kelly - Teleflex, Inc.:
Thank you, Anthony. So, obviously, both treatments are going after BPH patients. I think that our clinical data, and in particular, as it applies to sexual dysfunction, the reduction in catheter rate is critically important for men. And I'm speaking, Anthony, as a 52-year-old man myself. I personally would not want to wear a catheter. I would not want to have any impact on sexual dysfunction. And where we're targeting taking our share from is from drug dropout. That's where our core market we believe is, not from the surgery market. I'm not really sure whether Rezūm is targeting at the TURP market and taking share in that smaller segment. It does to me appear to be more, at least from my perspective, to be more of an ablative therapy compared to the other ablative therapies, whereas ours, we believe, is just a better solution; non-invasive, great clinical data, very fast recovery time, no catheter, no sexual dysfunction, so we still feel very confident that the clinical data will bear out in the long term.
Anthony Petrone - Jefferies LLC:
Thanks again, guys.
Liam J. Kelly - Teleflex, Inc.:
Thanks, Anthony.
Thomas E. Powell - Teleflex, Inc.:
Thank you.
Operator:
Thank you. Our next question is from Mike Matson with Needham & Company. Your line is open.
Mike Matson - Needham & Co. LLC:
Good morning. Thanks for taking my questions. I guess I wanted to start with the China business. Your growth was 14%, which is good, but it is down a little from, I think, the 22% you did last quarter. So, can you just give us an update there and then can you remind us when you'll start to lap kind of your move to the direct sales model there?
Liam J. Kelly - Teleflex, Inc.:
Yes. And Mike, you absolutely nailed it there. That's exactly what we've done. We lapped the go-direct timeframe in quarter three. So that is why you would see a slight deceleration in the China growth from that go-direct. But, still, we're very, very happy with the performance. We believe that we have done excellent execution on the go-direct of our vascular and cardiac business within China, and we continue to be encouraged by what we see within the growth within the key China market.
Mike Matson - Needham & Co. LLC:
Okay. So, it's largely a comp issue then and not any kind of a slowdown...
Liam J. Kelly - Teleflex, Inc.:
Absolutely, Mike.
Mike Matson - Needham & Co. LLC:
...in the economy or healthcare spending or anything like that.
Liam J. Kelly - Teleflex, Inc.:
No, no, we – even if there is a slight downturn in the general economy, I can't see it having that much impact on healthcare. The government is very focused on providing significant continued investment into healthcare. And quite frankly, the people are demanding better healthcare and it's a pay for service and they're demanding better healthcare within there. And of course, we all know it's hard to determine what exactly is a slowdown in that geography with the data that comes out. But we haven't seen it in our business, Mike, to answer your question directly.
Mike Matson - Needham & Co. LLC:
Okay. Thank you. And then just a couple of financial questions. So the 4.6% kind of legacy organic growth, you did have the shift of orders from Q2 to Q3. So, are you able to quantify how much of that 4.6% was due to those orders that got moved from Q2 to Q3?
Liam J. Kelly - Teleflex, Inc.:
I am because we have that data. So the uptick – initially, we got a bolus of orders in excess of $3 million, about $2.2 million of it was sticky to the quarter. And that was anticipated in our guidance as well, Mike.
Mike Matson - Needham & Co. LLC:
Okay. Thanks. And then just the – Tom mentioned that you're raising your guidance despite the increased currency headwind. So, can you quantify how much additional EPS headwind you're expecting at this point to the annual EPS versus what you were expecting, I guess, as of your last quarterly call?
Thomas E. Powell - Teleflex, Inc.:
Are you referencing related to the change in currency?
Mike Matson - Needham & Co. LLC:
Yeah, exactly. Yeah. How much more – or I guess I should say how much has it changed, because maybe you had a tailwind and it's just less of a tailwind now or maybe it's a headwind and it's more of a headwind now?
Thomas E. Powell - Teleflex, Inc.:
Well, just for currency overall, on the revenue impact, it's still a tailwind for the year. We now estimate that tailwind to be about 150 basis points. It used to be an expectation of 200 basis points. So that's going to reduce our revenue obviously, and that has an impact to our third and fourth quarter earnings. I would say that's kind of on the negative side. We also have some dilution from the recent acquisitions that's going to hit the fourth quarter, the incremental tariffs. And on the positive side of the equation, we've got reduced interest expense as a result of the swap and a frankly strong third quarter earnings in part due to taxes and some other factors. So, a number of pluses and minuses that kind of all come together to offset what our expectations are in the fourth quarter as to the pluses and minuses from currency and other factors.
Mike Matson - Needham & Co. LLC:
Okay. That's helpful. Thank you.
Liam J. Kelly - Teleflex, Inc.:
Thanks, Mike.
Operator:
Thank you. Our next question is from Matt O'Brien with Piper Jaffray. Your line is open.
Matthew O'Brien - Piper Jaffray & Co.:
Thanks for taking the question, guys. I wanted to push first a bit on the gross margin expansion. I know it was asked. Just two pieces. One, it sounds like the restructuring is on track; can we just dive a bit in on what steps you've taken thus far with that and any early benefits you're seeing? And second, as we think about the bridge getting the company closer to the long-range plan of about 300 basis points by 2021, what piece between mix from acquisitions, restructuring, or core expansion/new products is the most important to get you there or, importantly, to bring you above that range?
Thomas E. Powell - Teleflex, Inc.:
Okay. Well, let me just first touch on I think you asked about restructuring. And so, as we look at all the programs out there that we have in place, there are a number of programs underway including, frankly, the 2014, 2016 and 2018 footprint realignment programs, the integration of Vascular Solutions and OEM manufacturing project. And if you combine all of these, the restructuring savings are in the range of $107 million to $127 million at the time they're fully completed. Now, what we talked about is through the end of 2017, we've realized $45 million of those savings, leaving another $62 million to $82 million for this year and through the completion of these projects. And the way to think about that is we had talked about $25 million to $35 million being in the timeframe of 2019 to 2021 and then we obviously realize – we'll realize some this year and then that leaves the remainder for 2022 to 2025 timeframe. So, the way to think about that remaining $62 million to $82 million of savings is probably a quarter of it this year, about 40% over the timeframe 2019 to 2021, and then the balance thereafter. And how that plays into our longer-term gross margin objective is it's certainly a component, but as we look at the most important components of that 200 to 350 margin – or I should say basis point margin expansion through 2021, the biggest impact is really related to mix. So the favorable benefit from NeoTract, Vascular Solutions, and other products such as our PICCs and Vidacare really are the largest component driving that margin expansion. The restructuring program is certainly a component of it, and if you think about the numbers that I cited of $25 million to $35 million, that's about 100 basis points at the midpoint of that range. And again, I would say that mix will play a more important piece of the margin expansion story over that 2019-2021 timeframe.
Matthew O'Brien - Piper Jaffray & Co.:
Okay. Thanks so much. That's very helpful. And then the second one is on UroLift. The clinical work there has been really strong the past few months, both on the results front and the cadence. So I wanted to ask your thoughts on the investment specifically as it relates to competition there. So, what is the latest on competition in the marketplace and are more investments needed in the channel or on the clinical front? Or are you pegging these efforts as expansionary in the marketplace thus far?
Liam J. Kelly - Teleflex, Inc.:
So our view is that we will continue to do investment behind clinical data. I think I've spoken to the investment community about a study we just kicked off in France. That's going to assist our reimbursement within Europe. And we have never thought, Matt, that we would be alone in this large BPH market. But I think we have the most robust clinical data out there in the market and that was borne out in this conference in Paris where we had five papers presented at the conference, which was more than any other technology in any area of men's health as far as I could see and also much more than any other – more papers for UroLift than any other BPH technology that's out there. Now, I can assure you there's probably three skunkworks going on somewhere working on a treatment for BPH. I can also assure you, in the last 20 years, the graveyard is full of technologies that were supposed to address BPH and that UroLift is the first one that has come up with a unique methodology to treat BPH with the symptoms that we have. So, you can expect to see a continued cadence in investment on further clinical data to support the UroLift and making it a frontline care for BPH.
Matthew O'Brien - Piper Jaffray & Co.:
Okay. Thanks. And you just don't – you don't think it's incremental due to that competition. It's just the same cadence that you would have expected.
Liam J. Kelly - Teleflex, Inc.:
Yeah. We have an internal plan for ongoing clinical data that was considered when we put out our three-year plan. So I wouldn't see any change to that required to do what we need to do with UroLift to make it the standard of care, Matt.
Matthew O'Brien - Piper Jaffray & Co.:
Okay. Perfect. Thank you so much.
Operator:
Thank you. Our next question is from Brian Weinstein with William Blair. Your line is open.
Brian David Weinstein - William Blair & Co. LLC:
Hey, guys. Thanks for taking the questions.
Liam J. Kelly - Teleflex, Inc.:
Good morning.
Brian David Weinstein - William Blair & Co. LLC:
Obviously, a much better quarter this quarter and everybody seems pleased with it. But it has been a more variable year here. And as I think back over the last couple of years, it seems like it's more variable than what we've seen over the last couple of years. And I'm just curious as to whether you guys have any strong feelings as to why there seems to be more variability in results. And specifically, Liam, when you were in the COO role, things seemed to be fairly stable. I don't think that you have filled that role in the organization. Do you think that there's a need for a COO to come on in and help bring a little bit more stability, so that we don't have the ups and downs that we've seen this year?
Liam J. Kelly - Teleflex, Inc.:
Well, Brian, I think that, consistently, if you look at on a full year basis, Teleflex has consistently performed. From 2014 to 2017, our average constant currency growth was 4%. And you know, Brian, this is almost like when you get a little bit older and you look back and you think every summer was a great summer. In the reality, not every summer was a great summer. And even within Teleflex during that time, and thank you for complimenting me on my COO role, but even during that time, Brian, there were ebbs and flows. We had nuances within the quarter. But, as we saw this quarter, I always try to remind people with every ebb there is a flow. And we saw that rebound very strongly within this quarter as well. We have made management changes by appointing a Head of North America to make sure that we have that consistent of performance. And I think that we don't give quarterly guidance, Brian, and Teleflex should be judged on how we do in an annual basis. And consistently, we performed on an annual basis.
Brian David Weinstein - William Blair & Co. LLC:
Okay. Great. Thanks for that. And then just my follow-up would be, you talked a little bit about some areas where you're may be winning some share. But can you talk just more broadly about categories where there are share wins and maybe some increased competition and some share losses? Thank you.
Liam J. Kelly - Teleflex, Inc.:
Yeah. Sure. So, I think I'll start with the share wins, for sure. I think that obviously PICCs is a nice area for us for share wins. Vidacare continues to perform very well and that's not really a share win, that's converting the market. Our Interventional business with the VSI portfolio continues to grow and take share. And I'm really encouraged by what we're doing within Asia-Pacific. I'm not sure that I would categorize it as a share loss, but we do see tougher economic volatility, if I can put it that way, within EMEA where there's more pricing pressure within the market. It's always kind of been there, but Europe continues to be a fairly price sensitive market for Teleflex and our portfolio there. And that's probably the area I'd point out where we see a little bit of additional competition.
Brian David Weinstein - William Blair & Co. LLC:
Thank you.
Operator:
Thank you. Our next question is from Dave Turkaly with JMP Securities. Your line is open.
David Turkaly - JMP Securities LLC:
Hey. Great. Thanks. Just really quickly, you just mentioned Vascular Solutions; obviously, 21% growth is a big number. I'm just curious is there anything you'd point to driving that from a new product front or sales force or what would – and how sustainable do you think that is?
Liam J. Kelly - Teleflex, Inc.:
So, within the 21%, obviously, for VSI, there is – the go-direct is counted within that. So that's a large portion. But, outside of that, we do see Turnpike as a product continue to drive significant growth within that portfolio. That's still growing in the 40% range. We see the GuideLiner and TrapLiner doing an excellent job for us, and we'll continue to take share within that segment. And those would be two of the areas. And we've also launched new products around guidewires that are building momentum within the marketplace. But we're incredibly pleased with VSI and the performance of VSI, and indeed, the performance of our overall Interventional business unit because, along with VSI, we're seeing a nice uptick on legacy products because of the additional sales force. And we didn't build sales synergies into our models, but I'm seeing that we are getting them.
David Turkaly - JMP Securities LLC:
Great. And then onto this Essential Medical, the MANTA. Based on the description in the picture there in the collagen component, it sounds like it's maybe similar to the old Angio-Seal Kensey Nash Terumo device, but maybe for a larger access. Just curious if that's the case and then would a good approximation of a domestic ASP be $200? Thanks so much.
Liam J. Kelly - Teleflex, Inc.:
So this is a different market segment. It is similar to that product that you've mentioned, but it's a very different market segment. And therefore, we believe it would attract a significantly higher ASP. Remember, Dave, that when they're closing these large bore closures, they're using two or three of these devices right now. So it's an expensive closure system for them. They also have 7%, on average, complications, as I said in my prepared remarks. We can take those down to 2% in the clinical data that we demonstrated. And as I also said earlier, we got to prove this, but what we have anecdotally seen in the Netherlands where we have significant penetration with this device is that they're actually able to make the cath lab more efficient. Now, if you could get one more patient through that cath lab, all bets are off as to the price, because they won't even be talking about the price of the product because it just makes them more efficient. And of course, they will know that, for vascular complications, that patient is going to cost the hospital $18,000 to get that patient treated. So, therefore, this will have a higher price point than the one you stated for sure.
David Turkaly - JMP Securities LLC:
That's great to hear. Thank you.
Operator:
Thank you. Our next question is from Isaac Ro with Goldman Sachs. Your line is open.
Isaac Ro - Goldman Sachs & Co. LLC:
Good morning, guys. Thank you. First question is on NeoTract. Just interested in some of the investments you're making in Japan, if you could maybe qualify and quantify what those mean for that part of the business.
Liam J. Kelly - Teleflex, Inc.:
Okay. And yet again, the investments in Japan were contemplated in our three-year guidance. So, to make that clear, we will begin by putting some clinical people on the ground to start develop the market. The key here is to get our reimbursement, so we will work in the fourth quarter beginning and then in 2019 to bring the product to get some clinical exposure to it. And then we will obviously begin immediately going through the 12- to 18-month process to get reimbursement for the product. We will then move to get those clinicians that we would have developed to do the clinical work for the post-market study that is required as part of our approval. But I got to tell you, we couldn't be more excited about getting this product Shonin approved. We believe that in using the same criteria to size the U.S. market at about $6 billion, the Japanese market is about $2 billion, and the Interventional Urology team has done an excellent job. I would like to remind people, we only submitted this Shonin in Q1. This is an incredibly fast time line to get approval within the same calendar year. Internally, we were expecting it to take at least 12 months. So, we couldn't be more pleased with the progress we're making there, and we will work to develop that market during 2019 in anticipation of reimbursement sometime thereafter.
Isaac Ro - Goldman Sachs & Co. LLC:
Helpful. And then just a follow question on M&A. Obviously, if you listen to the earnings calls across the industry, most companies, if not all of them, are pretty active in looking for assets. So, you guys have been able to pull off a couple of pretty notable deals here that have already started to sort of change the growth profile of the company. Can you talk a little bit more about where you're looking at the margin to find assets and valuations that make sense, and whether that be tied to a therapeutic category or somatic category or just size and scope? Just kind of curious how you're finding assets and kind of how we should think about pacing of deal flow over the next 12, 18 months.
Liam J. Kelly - Teleflex, Inc.:
Well, I think MANTA is an interesting example like that. We met with Greg and the entire team four years ago, and we had been building that relationship, watching their progress very closely. That's one example as to how we find assets. Obviously, another one is the banking world know that Teleflex is very acquisitive. They know what we're looking for in the assets that we want. They know that we're very focused on interventional space, men's health, the vascular space and also anesthesia and surgical. So they will bring us assets as long as they know that it meets our growth criteria, our margin expansion criteria, and our leverage criteria. As Tom outlined in his prepared remarks, we're now on a gross leverage down near to the low 3s. So that gives me encouragement that we also have the financial ability to do activity if we find the right assets. It's not lost on us in Teleflex that we're a different organization. We will stick to our strategic criteria and we only get credit for the good acquisitions, not credit for acquisitions, full stop. So, we're very focused on finding the right assets and executing. And I think it's become a core competence of this organization to find these assets, bring them into the Teleflex family and accelerate the growth thereafter by leveraging our global footprint.
Isaac Ro - Goldman Sachs & Co. LLC:
Got it. Thank you, guys.
Liam J. Kelly - Teleflex, Inc.:
Cheers, Isaac.
Thomas E. Powell - Teleflex, Inc.:
Thank you.
Operator:
Thank you. Our next question is from Kristen Stewart with Barclays. Your line is open.
Kristen Stewart - Barclays Investment Bank:
Hey, guys. Thanks for taking my questions.
Liam J. Kelly - Teleflex, Inc.:
Hey, Kristen. Welcome back.
Thomas E. Powell - Teleflex, Inc.:
Hey, Kristen.
Kristen Stewart - Barclays Investment Bank:
Thank you very much. It's good to be back. I just wanted to just kind of go over the EPS guidance both on a non-GAAP and a GAAP basis. Am I kind of doing the math right that the change in the tax rate contributes about $0.20 to the full year?
Thomas E. Powell - Teleflex, Inc.:
It would be the right calculation, yeah.
Kristen Stewart - Barclays Investment Bank:
Okay. And then on the non-GAAP guidance or the regular GAAP guidance, that was reduced by $0.60. I was wondering if you could just talk to why some of the restructuring and acquisition integration charges are going to be more significant now relative to what you guys are expecting a quarter ago.
Thomas E. Powell - Teleflex, Inc.:
Okay. Well, there's a couple of things that play into that. One was a change in some of the contingent consideration payments. As we continue to see the performance of some of the acquisitions, we adjust the amount of contingent consideration to reflect that. We also had an impairment during the quarter related to our Hotspur Technology which would roll into that. And then we had a restructuring program earlier this year that obviously had some impacts.
Kristen Stewart - Barclays Investment Bank:
Okay. Perfect. And then, last question just on acquisitions and the accretion/dilution. NeoTract had always been thought of as $0.35 to $0.40 accretion for next year. How is that looking and how should we just think about Essential Medical? Is that more dilutive next year from an earnings perspective or neutral?
Liam J. Kelly - Teleflex, Inc.:
So, I'll start with Essential. Obviously, Essential is dilutive in the fourth quarter to our earnings which is partially reflected in Tom's comments around our full year guidance. Now, we will give guidance for Essential in February. And the only reason I'm saying that, Kristen, is because it's very dependent on whether we need a panel review or not as I said a little earlier. And we will have greater line of sight on that when we come to give earnings guidance. Our expectation is that Essential will be dilutive in 2019 and then accretive thereafter. And then your other question was around NeoTract. Yes, we're well on track to have NeoTract to deliver in line with our expectation of $0.35 to $0.40 in 2019.
Kristen Stewart - Barclays Investment Bank:
Okay. Thanks very much, guys.
Thomas E. Powell - Teleflex, Inc.:
Thank you.
Liam J. Kelly - Teleflex, Inc.:
Thank you very much.
Operator:
Thank you. And that does conclude our Q&A session for today. I'd like to turn the call back over to Mr. Jake Elguicze for any further remarks.
Jake Elguicze - Teleflex, Inc.:
Thanks, operator. And thanks to everyone for joining us on the call today. This concludes the Teleflex Incorporated third quarter 2018 earnings conference call. Have a nice day.
Operator:
Ladies and gentlemen, thank you for participating in today's conference. This does conclude the today's program and you may all disconnect. Everyone have a great day.
Executives:
Jake Elguicze - Teleflex, Inc. Liam J. Kelly - Teleflex, Inc. Thomas E. Powell - Teleflex, Inc.
Analysts:
David Ryan Lewis - Morgan Stanley & Co. LLC Lawrence Keusch - Raymond James & Associates, Inc. Richard Newitter - Leerink Partners LLC Andrew Brackmann - William Blair & Co. LLC Anthony Petrone - Jefferies LLC Mike Matson - Needham & Co. LLC Chris Cooley - Stephens, Inc. Matthew Mishan - KeyBanc Capital Markets, Inc. Matthew O'Brien - Piper Jaffray & Co. Isaac Ro - Goldman Sachs & Co. LLC
Operator:
Good day, ladies and gentlemen, and welcome to Q2 Teleflex Incorporated Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this conference is being recorded. I would now like to introduce our host for today's conference, Mr. Jake Elguicze, Treasurer and Vice President of Investor Relations. Sir, you may begin.
Jake Elguicze - Teleflex, Inc.:
Good morning, everyone and welcome to the Teleflex Incorporated second quarter 2018 earnings conference call. The press release and slide to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing 855-859-2056 or for international calls, 404-537-3406, passcode 4890067. Participating on today's call are Liam Kelly, President and Chief Executive Officer and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks and then we'll open up the call for Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K which can be accessed on our website. With that, I'd like to turn the call over to Liam.
Liam J. Kelly - Teleflex, Inc.:
Thank you, Jake, and good morning everyone. During the second quarter, Teleflex revenue grew 15.4% on an as-reported basis and 12.4% on a constant currency basis. The constant currency revenue growth rate we achieved in the quarter continued to be fueled by our two most recent completed scale acquisitions, NeoTract and Vascular Solutions. We continue to invest behind businesses such as these that bring higher growth potential, are going to benefit most from demographics and augment our margin profile long term. To that end, I am pleased to report that NeoTract continued its strong momentum, delivering $47.7 million in revenue, which is an increase of approximately 58% as compared to the prior year period. During the quarter, we were very pleased to see that the prostatic urethral lift, PUL, procedure was included in the most recently provided AUA Guidelines as a standard of care for the treatment of benign prostate hyperplasia (sic) [benign prostatic hyperplasia] (00:02:55). In addition, findings from independent analysis performed in the UK confirmed the cost effectiveness of UroLIft as compared to surgery. Turning to Vascular Solutions, quarter two revenue reached $52.6 million, which represents an increase of approximately 17% as compared to the prior year period. We were very pleased to see that Vascular Solutions worldwide revenue grew at such a robust rate, driven by strength in both North America and EMEA, thanks in part to several distributor conversions which were completed as we exited 2017. As you may recall, part of Teleflex's acquisition criteria is to leverage our established O.U.S. infrastructure. This was an opportunity that we highlighted when we announced the deal and we remain confident in the continued performance of VSI globally. However, not everything in the quarter met our expectations, as our organic shipping day adjusted revenue growth rate took a step back from the level achieved during the first quarter of the year. Investors familiar with the Teleflex story understand that we are subject to ebbs and flows in our distributor ordering pattern. At times, these patterns have proven difficult to predict with accuracy and we believe them to be temporary and do not cause us concern as to our 2018 goals or our longer-term outlook. We are obviously disappointed to have seen this occur, as up until very late in the quarter ordering trends pointed to a sequential improvement. Unfortunately, due to some temporary unpredictable issues associated with the timing of distributor orders in advance of the July 4 holiday and certain product constraints from suppliers, that did not occur. Importantly though, during the quarter we saw positive end customer tracing data and we do not believe that second quarter core organic growth rate represents a trend. In fact, I can tell you that during the month of July, orders and revenue rebounded nicely, as distributors bought in significantly during the first week of the month. That coupled with a few other factors is why we continue to believe that we will grow our revenue on a constant currency basis between 12% and 13%, including full year organic revenue growth of between 5% and 5.5%. In a few moments, I will bridge for you how we get there. Turning to some other key metrics, during the quarter our adjusted gross and operating margins continued to expand, reaching 57.1% and 26%, respectively. The 120 basis point improvement in gross margin and the 90 basis point improvement in operating margin is a testament to the leverage that can be driven within our income statement. Finally, this culminated into adjusted earnings per share of $2.47, which is an increase of 21.1% over second quarter 2017. And despite foreign currency exchange rates being less favorable as compared to when we last provided guidance, we continue to have confidence in our ability to achieve our previously provided full year adjusted EPS guidance range of between $9.70 and $9.90 per share. With that as an overview, let's now look at quarter two revenues in more detail. Second quarter 2018 revenue totaled $609.9 million, which is an increase of 12.4% on a constant currency basis. Beginning with the components of organic revenue growth; during quarter two, we saw organic constant currency revenue growth of 3.6%. This included a benefit of approximately 1% from one additional shipping day. So, on a shipping day adjusted basis, we estimate our organic constant currency revenue growth was approximately 2.6%. This day adjusted organic growth consisted of 1.7% from new product introduction, 80 basis points from legacy product volumes, and positive pricing adding about 70 basis points. These positive contributors were partially offset by the surgical product exit which negatively impacted quarter two growth by about 60 basis points. Moving to the contribution we received from acquisitions, this quarter was all NeoTract, which added 8.8%. In fact, NeoTract revenue would have been even higher in quarter two had it not been for a product supply issue, as towards the end of June, we made a proactive change to one of the molds associated with the UroLift device. Because of this change, in a small number of cases we began to see the needle inserted into the prostate and retracted normally, but no implant deployed. A limited number of devices in the field were impacted and in the interest of the excellent reputation of UroLift, we made the decision to withdraw these products from customers. We have not seen any impact from any UroLift implants that were deployed. We since returned to using the original mold; however, some cases were delayed during the end of June because of this issue, most of which have been rescheduled for the third quarter of 2018. We are extremely proud of how quickly we were able to act to rectify this issue, and have been very pleased with the near universal physician support for our handling of the process. And while this is something you never want to happen, it has in no way altered the short- or long-term demand for UroLift, and we feel confident in our ability to meet that demand. Given the performance for the first six months of 2018 as well as our expectations for the remainder of the year, we are increasing our revenue expectation for NeoTract. Previously, we said that NeoTract would grow at least 40% over 2017 levels and that it would add approximately 50 basis point to our full year organic constant currency growth rate. We now expect that NeoTract will grow approximately 50% over 2017 levels, and it will add approximately 75 basis points towards our full year organic constant currency revenue growth rate. Turning next to our revenue performance by segment; Vascular North America second quarter revenue increased 1.4% on a constant currency basis to $80.1 million. When normalizing for the shipping day impact, we estimate that Vascular revenue growth was flat in the quarter. This was primarily due to the timing of orders and we expect this to come back in the second half of the year. Moving to Interventional North America, second quarter revenue was $65 million, which is an increase of approximately 11.3% on a constant currency basis. When normalizing for the shipping day impact, we estimate that Interventional revenues grew approximately 9.5%. The increase here is primarily the result of Vascular Solutions product as well as growth in our OnControl and AC3 product line. Turning to Anesthesia North America, second quarter revenue was $50.5 million, which is an increase of 2.7%. When normalizing for the impact of shipping days, we estimate that revenue growth within our Anesthesia segment was approximately 1%. Shifting to our Surgical North America business, its revenue decreased 9.2% on a constant currency basis to $40.7 million. When normalizing for the shipping day impact, we estimate that Surgical revenues would have declined 10.6%. Like Q1, the decrease in Surgical revenues was primarily due to the exit of a lower margin product line in the third quarter of 2017 as well as some supplier constraints. As we look forward into the second half of 2018, we expect that our Surgical business will be approximately flat on a constant currency basis. The improvement in the second half of 2018 as compared to the first half is primarily due to the easing of the comps associated with the product line exit. Moving to our overseas operations, second quarter EMEA revenues were up 2.8% to $153.4 million. Within this growth rate, M&A contributed approximately 80 basis points. When normalizing for the impact of M&A and shipping days, we estimate that organic revenue growth within this segment would have been 1.2%. Now to Asia; our second quarter revenue increased 5.9% on a constant currency basis to $72.4 million. Within this growth rate, M&A contributed approximately 1.5%. When normalizing for the impact of M&A, organic revenue growth within this segment was 4.4%. Shipping days did not have an impact on this segment. Organic growth in this segment was led by China, whose revenues expanded 22% and this was largely driven by an increase in volumes following our decision to take our business direct last year. Next, I'd like to brief you on our OEM segment. During the second quarter, revenue was up approximately 14.9% and reached $52.6 million. When normalizing for the shipping day impact, we estimate that the increase in OEM revenue would have been 14.5%. The increase in OEM revenue was all organic and was due to higher sales volume of existing products. And lastly, second quarter revenue for the businesses within our All Other category was up 98.6% on a constant currency basis, totaling $95.2 million. Growth here is primarily attributable to the acquisition of NeoTract and to a lesser extent, our Latin American business which grew approximately 11.5%. Also during the quarter, we signed a total of 16 GPO and IDN agreements, of which 7 were new agreements. That completes my comments on quarter two revenue performance. Turning to a brief update on UroLift. During the quarter, the product saw numerous milestones from a society and clinical evidence perspective. First, we were thrilled that the PUL procedure was included in the updated AUA Guidelines announced during the association's annual meeting in late May. Not only did the AUA recommends the PUL procedure as part of the standard of care for BPH, it also included favorable language that physicians should consider PUL as a potential treatment for men with benign prostate hyperplasia (sic) [benign prostatic hyperplasia] (00:14:05). This is especially important for men who want to avoid sexual dysfunction, as UroLift remains the only minimally invasive treatment option that has been shown to provide rapid and durable symptom and urinary flow rate improvement without inducing sustained sexual dysfunction. We also had several meaningful posters and presentations at AUA, highlighting the expanded body of clinical evidence for UroLift, and further extending its leadership as one of the most studied treatments for BPH and, indeed, one of the most studied treatments in urology. An independent analysis of UroLift in the UK using actual NHS data highlighted the cost effectiveness and improved quality of life associated with UroLift as compared to TURP. Post-surgery complications, including urinary tract infections and blood transfusions, are expensive complications of TURP and other tissue destructive procedures. The UroLift system offers men a new minimally invasive option that reduces the occurrence of these significant side effects, demonstrating a predicted savings of approximately £27 million per year over five years for each annual cohort of patient. While the one-year MedLift study, on which the approval of median lobe indications was based, demonstrated safety and efficacy consistent with the LIFT study, including no instance of de novo, sustained sexual dysfunction, there was a significant IPSS improvement, low retreatment rate, and adverse events were mild to moderate. And lastly, a thought leading urologist presented a predictors of response analysis of the LIFT randomized study, which measured the outcomes of patients in two categories. Those who had a UroLift earlier in the BPH disease progression, while bladder function was still preserved, and those who had a UroLift later in the disease progression after bladder function had been compromised. The study showed that earlier intervention with UroLift helps to preserve the bladder from deteriorating and leads to better outcomes than interventions later, when the bladder may have lost some of its function. We think this is a first step in building a body of clinical evidence that supports UroLift can be a first-line therapy. And before I turn the call over to Tom, given that we are reaffirming both our full year constant currency revenue growth rate of between 12% and 13% as well as our full year organic constant currency revenue growth rate of between 5% and 5.5%, I would like to spend a few moments to explain how we expect to get there on an organic basis. This slide starts with the organic constant currency revenue growth rate that we achieved during the first six months of the year and highlights the drivers of revenue growth acceleration necessary in the second half of the year to achieve the midpoint of our full year organic constant currency revenue guidance range of between 5% and 5.5%. Admittedly, at first glance this appears to be a large increase. However, as you see in this slide, the drivers of this revenue growth acceleration are well defined and we believe achievable. First, let's start with NeoTract. During the first half of 2018, none of the NeoTract revenue growth has been considered organic. That changes beginning in the fourth quarter. And while it will only be considered organic for one quarter, we estimate that NeoTract will add approximately 1.5% towards our organic growth rate in the second half of the year. Now let's turn to Vascular Solutions. Growth within Vascular Solutions has been strong during the first six months of the year, and we expect that to further improve in the back half of 2018. The main driver behind this improvement stems from the distributor-to-direct conversions that occurred in late 2017. As I am sure you will all recall, as we began the negotiations of these various distributor acquisitions in the second half of 2017, revenue growth of Vascular Solutions products suffered in international markets, as distributors simply stopped buying product in advance of Teleflex acquiring them. With those distributor conversions behind us, the second half of the year should show strong international revenue growth. Third, we have one additional shipping day in the second half of the year as compared to the first, and this should translate into approximately one additional point of revenue growth. Fourth, the headwinds in the surgical exit product line eased. We still expect there will be a negative impact from this exit. However, during the first half of 2018, this impacted us negatively by approximately 60 basis points, while in the back half of the year, this will only impact us negatively by about 20 basis points. Therefore, we will see an increase in the second half of the year by approximately 40 basis points. And lastly, we expect an improvement in our base business of approximately 120 basis points. This is primarily due to improvements within Asia and our expectation of higher EZ-IO volumes in the second half of the year, coupled with volume moving from Q2 to the second half of the year. The point of this exercise is that while at first glance it appears that we are talking about a large increase, there are a handful of well-defined items that are within our control, and we feel confident in our ability to achieve them. That takes me to the end of my prepared remarks. At this time, I would like to turn the call over to Tom. Tom?
Thomas E. Powell - Teleflex, Inc.:
Thanks, Liam, and good morning, everyone. Given the previous discussion of the company's revenue performance, I'll begin at the gross profit line. For the quarter, adjusted gross profit was $348.3 million versus $295.3 million in the prior year quarter, or an increase of 18%. Adjusted gross margin was 57.1%, a 120 basis point increase when compared to the prior year period. The expansion in adjusted gross margin reflects the impacts of the acquisitions of Vascular Solutions and NeoTract, favorable fluctuations in foreign currency exchange rates, and the favorable impact of cost improvement initiatives. Adjusted operating margin improved 90 basis points to 26%. The improvement was related to the gross margin flow-through. However, this was partially offset by the inclusion of NeoTract, which currently operates at a higher OpEx cost structure. During the quarter, adjusted gross margin and adjusted operating margin would have been approximately 50 basis points higher had we not incurred approximately $2.7 million of expense associated with the NeoTract production issue that Liam mentioned earlier. Adjusted net interest expense increased to $26.5 million from $19.4 million in the prior year quarter. The increase reflects the impact of additional borrowings required to finance the acquisitions of Vascular Solutions and NeoTract. For the quarter, the adjusted tax rate was 12.7% versus 16.6% in the prior year period. The year-over-year decline reflects the impacts of the recently enacted Tax Cuts and Jobs Act Tax and a larger tax windfall benefit this year versus last. On the bottom line, for the second quarter 2018, adjusted earnings per share increased 21.1% to $2.47. The second quarter performance is testament to the financial leverage potential of Teleflex's business model. Before turning to the balance sheet, I'll take a moment to comment on second quarter GAAP earnings. For the second quarter, GAAP EPS was a loss of $0.06. The GAAP loss reflects the impact of $57.8 million of restructuring, restructuring related and impairment expenses, which primarily relate to the company's recently announced 2018 footprint realignment plan. Additionally, during the quarter, we incurred $25.7 million of contingent consideration expense as a result of an increase in the longer-term revenue expectations for NeoTract. Turning now to balance sheet and cash flow highlights. For the first six months of the year, cash flow from operations totaled $182 million, down approximately 8% over the prior year. The decrease was primarily due to changes in working capital, partially offset by favorable operating results. It is also worth noting that NeoTract fully achieved the first contingent consideration milestone. As such, the company made full payment of the $75 million milestone. Finally, during the quarter, our leverage level as defined under our credit facility stood at 3.4 times. And that completes my comments on the second quarter. Now, I'll move to an update of 2018 guidance. Beginning with revenue, we are reaffirming our full year constant currency revenue growth guidance range of between 12% and 13%. And we continue to expect our organic revenue growth will be between 5% and 5.5%. So, we now expect the combination of NeoTract and Vascular Solutions to contribute approximately 1.75% towards our full year organic growth rate, whereas previously we expected that combination to contribute approximately 1.5%. Because of a less favorable currency environment since we last provided guidance, most notably the euro, we are exhausting our as-reported revenue growth guidance from a range of between 15% and 16% to a range of between 14% and 15%. Based on our updated currency assumptions, this translates to an as-reported revenue dollar range of between $2.447 billion and $2.468 billion. We are also reaffirming both our previously provided adjusted gross margin guidance range of between 57.5% and 58%, and our adjusted operating margin guidance range of between 26.1% and 26.5%. We now expect our full year 2018 adjusted tax rate to be approximately 14.5%. This compares to our prior guidance which called for an adjusted tax rate of between 15% and 16%. The improvement in our full year tax rate guidance is primarily due to a larger tax windfall benefit than previously expected. On the bottom line, our outlook for 2018 adjusted earnings per share remains in the range of between $9.70 and $9.90, as we expect to be able to offset the earnings headwind from a less favorable foreign currency environment. And to summarize, as previously outlined, second quarter organic growth was soft relative to expectations, but we have line of sight to an acceleration of growth in the second half. As for NeoTract, the results continue to exceed expectations. We are very pleased with the progress to date, including revenue growth of 58% in the second quarter and an improved longer-term revenue outlook. Vascular Solutions is also performing well and posted growth of 16.8% during the second quarter. Our new products pipeline continues to build momentum and we're excited about the future potential of select pipeline opportunities such as RePlas. On the margin front, our restructuring and efficiency programs continue to deliver improved financial results and helped propel the second quarter adjusted gross margin to over 57% for the first time. The tax rate provided an added positive for the quarter. And all these factors came together to produce a real nice bottom line outcome. For the second quarter, adjusted earnings per share grew by 21.1% versus the prior year. And that concludes my prepared remarks. Now, I'd like to turn the call back to the operator for Q&A.
Operator:
And our first question comes from the line of David Lewis from Morgan Stanley. Your line is open.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Good morning. Liam, the acquired businesses are getting better, the core obviously 25% gets worse, but the ramp looks very steep. So, I believe you need kind of 2.5%, organic has to go to 5% in the back half and a big ramp into the third. So, why should investors have confidence you can deliver given these recent core disappointments? What's your level of conviction you can improve, and more importantly, that this pattern of kind of one step forward, two steps back can stop?
Liam J. Kelly - Teleflex, Inc.:
Thanks, David. So, that is why during the call that we tried to bridge from the 2.7% to give investors comfort as to the building blocks to our ability to drive our organic growth into the future. And we did reaffirm our 5% to 5.5%. And if you want to compare the first half to the second half, I'm happy to run through the drivers. NeoTract would roll into organic in the last quarter, and it adds 1.5%. NeoTract is performing exceptionally well, so therefore we believe that that is – we're very comfortable with that. VSI is performing well and it will add 1% in the second half of the year, just primarily driven by the go-directs in the EMEA. We also anniversary the surgical exit which will add 40 basis points. Vidacare volume, PICC volume, surgical supplier resolution, and the quarter two order rate rebalancing, we're very confident that's going to deliver 1.2%. And, of course, we have the additional shipping day which falls in the fourth quarter which will add 8%. And all of these factors, David, make me confident in our ability to achieve the full year organic guidance range and our ability to achieve our longer-term growth rates of 6% to 7%. I think that we should point out to investors that two of those elements are in the fourth quarter. So, NeoTract will roll off into the fourth quarter and also the billing days in the fourth quarter. So, what we would expect you to see is an uptick in Q3, but then a larger uptick in Q4. And we have line of sight to all of these. I agree with you that it's unfortunate with distributor timings, but quite frankly that's outside of our control, and on a full year basis, we're very confident on the 5% to 5.5% and our ability to deliver that and our 6% to 7% longer term. And if you look at our pro forma within the quarter, David, and if we normalize for NeoTract and the surgical exit, we're in excess of 6% pro forma. So, that gives me also confidence in our longer-term ability.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Okay. And, Liam, I'd just sort of follow up on that. I'll stick with growth. One, just you're as confident or more confident in the core, I'm very interested in the core improvement into the third quarter. Maybe you can just sort of reiterate your confidence there. And then just NeoTract obviously, that number is going up on the year. Your confidence in that number as you head through the fourth quarter and the investments you're making to instill that growth rate can be easily in excess of 50%. Thanks so much.
Liam J. Kelly - Teleflex, Inc.:
Okay, David. So, I'll go to the core, first of all, and if I take the core, excluding VSI, and if we look at that number, the core has grown at 2.2% for the first half of the year. Obviously, the shipping day in the latter half will impact the core. That should give us the percent. The surgical exit should add 40 basis points. And then in the All Other buckets where we have the order repositioning from Q2 into the back half, we overcome the supply issue, Vidacare will accelerate and APAC accelerate. Those are the drivers of that 1.2% and those are the building blocks as we look at it as a core business in the latter half of the year and then you layer on VSI and NeoTract. Regarding your question on our confidence in NeoTract, I mean NeoTract continues to perform exceptionally well. It was a superb acquisition for Teleflex. The supply issue had a modest impact of about $1 million with the quarter. That will simply be re-phased most likely into quarter three. We continue to invest behind it. The growth within NeoTract is not free. The growth within NeoTract is as a result of the investment decisions that Teleflex makes every day, put more resources behind that. And we're very confident and so much so that we've actually upped the guidance from at least 40% to be able to deliver 50%. And based on the performance of the assets, we believe it'll continue to do that. And the investments that will get us to that 50% are the increased sales heads that we spoke about previously. As we said in quarter one, we were going to add an additional seven sales heads to the organization. We're also investing in marketing. We've done a lot of direct-to-consumer initiatives, and all of these are leading to our confidence that we will get to that 50% growth rate within NeoTract.
Jake Elguicze - Teleflex, Inc.:
Operator, we can take the next question.
Operator:
And our next question comes from the line of Larry Keusch from Raymond James. Your line is now open.
Lawrence Keusch - Raymond James & Associates, Inc.:
Oh, hi. Good morning, everyone.
Liam J. Kelly - Teleflex, Inc.:
Good morning.
Lawrence Keusch - Raymond James & Associates, Inc.:
Liam, I want to come back to the distributor stocking/destocking issue. This has become a bit more of a frequent event than I think we've seen in the past, at least it's become more visible. So, I really wanted to understand, A, why you think that's happening and then, B, this now sounds like the second time that it's really caught you at the end of the quarter, and your visibility as you look forward on that since it seems to catch you by surprise quite often.
Liam J. Kelly - Teleflex, Inc.:
Yes. It has become a little bit unpredictable, Larry. And I can tell you that we received well in excess of $3 million in orders in the first week in July. Those orders we had anticipated would land in the last week of June. The fact that the 4th of July fell on a Wednesday rather than earlier in the week, we think, was the issue here that our distributors placed those orders on Monday rather than placing them as we anticipated on the Friday ahead of the 4th of July. They're always placed traditionally at the end of June for the 4th of July and that was a simple anomaly in this instance. I think to understand – the unpredictable nature of it is to understand how these distributors work. There is not one central ordering group. It is the sites and if you take, they can have up to 20 sites, a distribution hub to place their individual orders. Our expectation was that they would order in the end of June. The good news, Larry, if I can make any good news out of this is that it's happened in the second quarter. Anytime it has ever happened in a quarter, we've always recovered in the subsequent quarter if those orders are right. I have a high level of confidence that we'll because of the fact that we sell well in excess of $3 million in orders, above our expectation in the first week of July. It's simply a timing issue, Larry, unfortunately.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. That's helpful. And then, two other ones. I'll just rattle them off and let you address them. Coming back to the second half growth and some of what David was picking at, the All Other is the category that strikes me again as the most unpredictable. I think NeoTract will do well, obviously VSI should do well. The surgical exit is pretty explainable. You have mentioned a couple times EZ-IO and Asia. So, what again gives you the confidence that those revenues can come forward? And then, the second one is just on the manufacturing side around NeoTract, and I understand the issue with this specific mold that you had. But how do you drive increased volume, or said another way, how do you not have that manufacturing issue going forward to make sure that you can achieve your volume targets? Thank you.
Liam J. Kelly - Teleflex, Inc.:
Okay, Larry. So, I'll start with the All Other, the 1.2%. Obviously, a component of that is the ordering volume that moves from Q2 into the latter half of the year. We also had one of our suppliers for our surgical business and another supplier that had a late breaking issue. The surgical supplier had a fire, which caused about $2 million of volume that's going to move from Q2 into the latter half of the year. Vidacare, even though it's growing by around 14%, the intraosseous and Vidacare business through the half year, due to – and this happens at municipalities. The orders in the second quarter, our total growth within Vidacare and the intraosseous was around – on a constant currency non-days adjusted is about 8%, Larry. So that's just timing of orders because of municipality budgets. We expect that to come back. And we would anticipate a much stronger second half. And indeed we'll start to begin to see that in the third quarter. In APAC, we now have control over our channel within China. So we won't see as robust growth as we saw this quarter within China, but we will continue to see strong growth within China over prior year. We would also anticipate that we have an opportunity within Japan within the Vascular space that's going to help us to augment that and that quite frankly is pretty much a given. We have excellent line of sight into that. So again, Larry, a lot of confidence around that All Other 1.2% based on those building blocks. That's what gives me that high level of confidence. Your other question was about NeoTract and the mold issue and why we're confident that won't have an ongoing impact. So I think, Larry, the mold issue was a decision that we made to change the mold as part of the manufacturing improvement. We changed back very, very quickly to the old mold. And now we're manufacturing with that old mold and getting product out to customers. We were able to make that change in a very short period of time. I've got to tell you, I'm very proud of how quick the company acted. It had zero impact on patients. Physicians were very comfortable with how we handled it. And we are now currently manufacturing with that mold, and we'll definitely have enough product by the end of Q3 to eliminate all backorders at that time. And we're making excellent progress right now.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Perfect. Thank you very much.
Liam J. Kelly - Teleflex, Inc.:
Thanks, Larry.
Operator:
And our next question comes from the line of Richard Newitter from Leerink Partners. Your line is now open.
Richard Newitter - Leerink Partners LLC:
Hi. Thanks for taking the questions. I just wanted to follow up on your organic growth cadence for the year. I appreciate the color on the bridge from kind of how you get to 2Q to the back half of 2018. And I know that you said it's very 4Q weighted. But I think it's important, just if you can give us any directional comments on kind of how steep into the 4Q? My takeaway from your comments, the guide, the fact that two of the four main components that bridge you to acceleration occur in the fourth quarter. Improvement off 2Q levels could be something close to the 3% range and then a really, really big steep kind of 8%-plus performance in 4Q. Am I thinking about that directionally correct? Or is it going to be a little bit more balanced between 3Q and 4Q? Thanks.
Liam J. Kelly - Teleflex, Inc.:
So what I'll do for you, Rich, is I'll try and identify what's going to be the main drivers in Q4. And that'll obviously help then. And the impact specifically to Q4 of those drivers. So just two of the biggest drivers that hit in Q4 that are not in Q3 are obviously NeoTract and the billing days. In the quarter, those two elements will drive over 3.5% of growth within that quarter. So that should help you bridge that we should be getting our core business in the ballpark of a 5% in Q3. And then those other building blocks will come in in Q4. Of course, you'll have the surgical exit in both Q3 and Q4.
Richard Newitter - Leerink Partners LLC:
Okay. That's helpful.
Liam J. Kelly - Teleflex, Inc.:
Does that help? Okay good.
Richard Newitter - Leerink Partners LLC:
Yeah, it does, it does. Thank you. And then, Liam, so I'm going to ask you to do the impossible and predict the unpredictable. But July 4 seemed to be a potential point of unpredictability for this inventory and ordering pattern. You've seen the times over the past two years when it happened in the past. I guess as you look to 3Q and 4Q of this year, are there any potential – based on past experience, any potential times within the two respective upcoming quarters that you think an inventory – late in the quarter inventory ordering pattern could slip you up? And then what's the – is there anything you can do to kind of de-risk that? And how contingent is that 5% that you just kind of said vicinity for 3Q on a potential disruption from an inventory ordering disruption?
Liam J. Kelly - Teleflex, Inc.:
So, Rich, I appreciate the question. So it is somewhat difficult to have visibility. But I will tell you this, that we did see, as I said, in excess of $3 million coming in the very first few days of July, which is obviously the orders that we were anticipating the back end of June. That's in our run rate right now as a company. So I'm very confident that's going to carry through to the remainder of the year. In Q4 last year, distributors did not order late in December. So we have a reasonably light comparable. So if anything, I would expect a positive from distributor orders into Q4 based on returning to previous year normal patterns to buy ahead of the flu season in late December.
Richard Newitter - Leerink Partners LLC:
Okay. Thank you very much.
Liam J. Kelly - Teleflex, Inc.:
Thanks, Rich.
Operator:
And our next question comes from the line of Brian Weinstein from William Blair. Your line is now open.
Andrew Brackmann - William Blair & Co. LLC:
Hi, guys. This is actually Andrew Brackmann on for Brian this morning. Liam, might also ask you to predict the impossible. You notice that China was up 22% in the quarter. Any commentary that you can provide here on tariff impact? Thanks.
Liam J. Kelly - Teleflex, Inc.:
On tariff, yeah, so we believe that it's highly unlikely that tariffs will be placed on medical devices going into China. They have not been in the scope of any of the discussions that I have seen. Now, tariffs from product leaving China and coming into the U.S. that would be – we don't have a large exposure in China to manufacture product and the exposure that we have is in the region of about $17 million that we import from China, which is a very, very small part of our overall business. So, if there were tariffs placed on that, it would not have a significant impact on us. And of that $17 million, in actual fact, part of that volume will be moving out of that geography over the next couple of years, the biggest portion of it. So, I don't see that having a major impact. Tom, would you like to add?
Thomas E. Powell - Teleflex, Inc.:
I can probably give you a little more detail. So, our assessments of the product coming out of China currently is a total exposure of about $500,000 for the year. And this estimate doesn't include any tariffs that could be placed on purchased finished goods, which may impact future pricing, but it's absolutely those products coming out of China. Given the makeup of our products, we don't have much of an impact at all from steel or aluminum tariffs and the exposure really is again on China origin products, the largest exposure being on that first list. There's also some exposure on the third list of products. But again, we currently quantify that to be about $500,000 for the year and we'll absorb that as part of our forecasting and be able to still achieve our guidance as a result of that.
Andrew Brackmann - William Blair & Co. LLC:
Great. Thanks. And then my second question was you made the comment that there were some supplier constraints acting as a headwind in Q2. Any additional color there? Thanks.
Liam J. Kelly - Teleflex, Inc.:
Yeah. The main impact of this was a supplier in our surgical business that had a fire. And we had a urology supply issue overseas for EMEA. That impacted us by about $2 million within the quarter. The urology EMEA issue will be resolved in the quarter. The surgical issue will either be resolved late in Q3 or early in Q4.
Andrew Brackmann - William Blair & Co. LLC:
Thank you.
Operator:
And our next question comes from the line of Raj Denhoy from Jefferies. Your line is now open.
Anthony Petrone - Jefferies LLC:
Thanks. Anthony in for Raj. Maybe just jump to margins real quick, you haven't touched on that here. It's ahead of our expectations in the quarter. Obviously, at Analyst Day there was a number of drivers there, too specifically was mix and restructuring. Can you just walk through the uptick in the quarter, how much was mix versus restructuring? And I'll have a couple of follow-ups. Thanks.
Thomas E. Powell - Teleflex, Inc.:
Sure. So, as we look at the quarter and focusing on gross margin, probably the largest contributor during the quarter was NeoTract. VSI also provided a benefit. Pricing provided some benefit as we heard, I think it was 70 bps of positive pricing and then a very modest benefit from foreign exchange. I will point out that manufacturing was impacted by the UroLift expenditures. So, those are the big drivers in the second quarter gross margin. Now, on an operating margin, it obviously is benefiting from the gross margin drivers, although NeoTract is operating at a higher cost structure, so we don't get the same leverage in operating margin. It's actually about breakeven from an operating margin standpoint. And then VSI and SG&A probably provide a little more benefit on the operating margin. So, those are the key drivers in the quarter, so should come as no surprise that NeoTract is a pretty big component of gross margin.
Anthony Petrone - Jefferies LLC:
Yeah. And then just to stay on the topic then. Restructuring, can you just remind us what are the expectations for this year in terms of incremental margin to the bottom line? That will be the first follow-up. And then secondly just on NeoTract, can you give us a sense of the growth drivers sort of as you look at the back end of the year as it relates to deeper account penetration versus new account openings and again, maybe how all of this plays on the sort of temporary withdrawal of the device and then reentry? Thanks again.
Thomas E. Powell - Teleflex, Inc.:
Sure. In terms of the full year impact of the restructuring programs, we're going to contribute a little bit less than a point of margin expansion. Now, I have to say that that goes into a large component of pluses and minuses and helps frankly to offset some of the inflation that we're seeing. As we look at restructuring programs over the longer term, of all the programs that are currently out there and announced, we've got the 2014, 2016 and 2018 footprint programs as well as the integration of VSI and the OEM manufacturing project. In total, those projects will generate savings of $107 million and $127 million. And we outlined the cadence of that. About $45 million of that savings was realized through the end of 2017. We expect another $25 million to $35 million over the period 2019 to 2021, and then the balance 2021 to 2024. And some of the reasons for that that we're drawing out savings schedule is the more recent footprint alignment programs really involve working through the German labor law requirements which have a lengthy notice period. And then we'll take time to also develop replacement machinery and design, and then we'll stagger some of those transitions to leverage our internal workforce and candidly de-risk the project. So, we have savings forthcoming over the next number of years. And again this year, it's part of the whole package of savings that gets to that gross margin target.
Liam J. Kelly - Teleflex, Inc.:
I'll cover your question on UroLift. So, we continue to make good progress with our rep hires. We continue to follow our strategy of going deep rather than wide. We continue to see excellent progress on building champions within the urology practices and, obviously, we're buoyed by the AUA Guidelines that I spoke about during my prepared remarks. We now have 250 million lives covered. We have trained 1,600 urologists. 60% of the cases approximately are still coming from the ASC and the office (00:48:51). So, that continues to bolster this. And obviously, we continue to invest behind it. As I said on the Q1 call, we're going to add another 78 reps within the year. So, we're going to be well above the original expectations that NeoTract as a stand-alone company had from an investment profile. And all of that is helping us to augment the top line revenue growth and put it in a position to go to update our NeoTract expectations from at least 40% to exceed or to reach 50% within this year. And we're still very bullish on the, at least, 20% CAGR over the next three years as we outlined during our Analyst Day.
Anthony Petrone - Jefferies LLC:
Thanks.
Operator:
And our next question comes from the line of Matt Matson (sic) [Mike Matson] (00:49:43) from Needham & Company. Your line is now open.
Mike Matson - Needham & Co. LLC:
Hi. Good morning. Thanks for taking my questions. I guess I just want to go back to the UroLift mold issue. I know it had a margin impact, but did it have an impact on sales and can you quantify that?
Liam J. Kelly - Teleflex, Inc.:
Yeah. Mike, as I said, there was about $1 million of sales that moved from Q2. Given the fact that this product does benefit from the demographics, but is not an emergent procedure, almost all of those, if not all of them will be just repositioned into Q3. So, we don't see a significant impact. And we also see we have a modest backorder now, but we'll have that resolved by the end of Q3. And we don't see it having any impact on our short, medium or long-term aspirations for the growth of this company.
Mike Matson - Needham & Co. LLC:
Okay. Thanks. And then pricing at 70 basis points seemed a little bit higher than where it had been trending and I know there's probably some quarter-to-quarter volatility there, but is that sustainable and can you just remind us where you're getting the positive pricing, which products or businesses generally?
Liam J. Kelly - Teleflex, Inc.:
So, most of the pricing that you see there is as a result of our go-direct that we did last year in Europe as part of the VSI go-direct. The core pricing is normally pretty flat.
Mike Matson - Needham & Co. LLC:
Okay. Thanks. And then finally, I know there was a question about the tariffs, but we've also seen costs going up for raw materials, oil, resin, things like that, as well as labor costs. So, maybe you could just comment on that. Thanks.
Thomas E. Powell - Teleflex, Inc.:
Okay. So, we've looked at the inflation in raw materials and don't see a meaningful impact as of yet. Where we are seeing some inflation to your point is in the labor markets. In Mexico and Czech Republic, in particular, we've seen tight labor supply which has put some pressure on wages. So, we've actually made some responses to maintain our competitiveness in those markets and that has led to additional cost during the year.
Mike Matson - Needham & Co. LLC:
All right. Thanks a lot.
Jake Elguicze - Teleflex, Inc.:
Thanks, Michael.
Operator:
And our next question comes from the line of Chris Cooley from Stephens. Your line is now open.
Chris Cooley - Stephens, Inc.:
Good morning. Thanks for taking the questions. Just two for me at this point. Tom or maybe Liam, when we look back basically from 2015 forward and appreciating that the portfolio mix has changed pretty significantly, underlying volume growth kind of averages out around 1% approximately. Could you help us maybe just come back to that volume number again and maybe think about why that wouldn't be higher as we look at this historically closer to 3-ish-plus percent, kind of more in line with general surgery? Give us confidence in kind of why we can see that step-up. And then just my follow-on, Tom, would you mind reminding us what's available in terms of capacity on the existing credit facilities? Thank you.
Liam J. Kelly - Teleflex, Inc.:
Hey, Chris. I'll take the volume one. So, I think when you look at volume, you got to include new products. So, you got to add the two of those together and our new products, I think, was 1.7% for the quarter. So, that really is how you should try and look at volume with regards to Teleflex. I do think that it's an important point that I'd like to make is that even though in the quarter the volume in the key North American market was in line with our expectations, our tracings as in end customer demand was almost 4%. So, again, that gives us confidence that – I think we've already seen it actually that that – that step function from volume coming from these distributor orders would right itself, and it's already righted itself in the first week of July just based on the tracings. That disconnect between the recognized revenue and the strong tracings within the market helps us have a lot of comfort around the fact that our volume will return in the second quarter, and we should see a core organic growth improvement in the third quarter. And Tom will take the other question that you had.
Thomas E. Powell - Teleflex, Inc.:
So, you were looking for availability on our credit facility. We have about $650 million of availability at the end of the quarter.
Chris Cooley - Stephens, Inc.:
Thank you.
Jake Elguicze - Teleflex, Inc.:
Thanks, Chris.
Operator:
And our next question comes from the line of Matthew Mishan from KeyBanc. Your line is now open.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Great. Thank you for taking the questions, guys. So, I just want to make sure I have this right because I think there's a lot of moving pieces, but it doesn't seem all that bad. The two pieces that you're talking about are a distributor order that got pushed from the end of June into the first week of July, and then the second piece is a product supply issue with Urotrack (00:55:01) that's already resolved. Are those the two pieces?
Liam J. Kelly - Teleflex, Inc.:
Pretty close. So, the distributor orders are within the North America that moved from the end of June into the first week in July, and that was in excess of $3 million. The actual product supply issues were related to our surgical business because of a fire one of our suppliers had late in the quarter. And to a lesser extent, a urology supplier in EMEA and they total about $2 million.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
And have those been resolved?
Liam J. Kelly - Teleflex, Inc.:
The urology supply will be resolved within the quarter. The surgical supply will be resolved either late in Q3 or early into Q4, but it will be resolved before the end of the year.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Okay. And then just can you give us an – and I'm sorry if I missed it. It was a busy morning. Any update you can give us on the clinical trial for RePlas? How many patients have you enrolled so far? And some of the early results from the initial patients? And then just lastly, any update you can give on Percuvance?
Liam J. Kelly - Teleflex, Inc.:
Okay. So on Percuvance, I can start there if you don't mind, Chris (sic) [Matt] (00:56:16), we've submitted our 510(k). That happened early in this quarter, quarter three. So we're right on schedule there. With regard to RePlas, the BLA submission is still on plan for Q1 of 2019. And in all of it, we will have completed enrollment and the infusion of 24 subjects in the Phase 1 clinical trial. And we should have the final report by Q4 of 2018. Unfortunately, Chris (sic) [Matt] (00:56:46), you don't get preliminary reports on a clinical study. You got to wait until Q4 to get them, but we're – or, Matt, sorry. My apologies. But the BLA submission is still on track for Q1 of 2019. I would take this moment to point out that there was some – this Pittsburgh Study Of Medicine (sic) [Pittsburgh School of Medicine] (00:57:09) completed a study of 500 trauma patients where they infused them, some with plasma and some without. And they actually showed a cohort of those patients who got two units and the others that did not. There was a 77% survival rate on the patients who got two units of plasma versus 67% survival rate on those that did not. And this is one of our target markets for freeze-dried plasma when it becomes available. And we're encouraged by that study coming out that is coincidental as it leads up to our approval to have RePlas in the marketplace.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
All right. Thank you very much, Liam.
Liam J. Kelly - Teleflex, Inc.:
Thanks, Matt.
Operator:
And our next question comes from the line of Matthew O'Brien from Piper Jaffray. Your line is now open.
Matthew O'Brien - Piper Jaffray & Co.:
Thanks so much and good morning. Just a couple questions for me. On the distributor issues, I think Liam in the past you've mentioned, hey, this happens occasionally and then for a quarter and then the demand comes back. But this is now two out of the last three quarters where this has happened. So just wondering if there's anything that Teleflex has been doing internally that's causing some kind of gaming from your distributors that's different than in the past? Or just said another way, just the comfort that this will be more of a once every kind of year or six quarter kind of phenomenon versus two out of every three quarters now?
Liam J. Kelly - Teleflex, Inc.:
Yeah. Matt, I think that there's nothing that we have changed and that we are doing differently with our distributors. As we get – VSI has already rolled into organic and as NeoTract rolls into organic, those two product categories do not traditionally go through distributors. In previous years, 50% of our volume went through the distributor, the box-moving distributors. As we go into 2019, that will move down to one-third of our business going through these box-moving distributors. So we'll be less exposed to volatility within them, and quite frankly, Matt, I look forward to that day because it is, I've got to tell you, a frustration within Teleflex as much as it is for our investors.
Matthew O'Brien - Piper Jaffray & Co.:
Okay. That makes a ton of sense. And then as far as UroLift goes, I'm a little curious as to why you decided to make the change to the molding process just given how fast that business is growing. And then is there any risk here in Q3 as the sales force is dealing with a little bit of a backlog, the new AUA Guidelines that there could be just a little bit of a slowdown in terms of the growth of that business? And then with the molding change, is there any update to the Gen 2 product timing?
Liam J. Kelly - Teleflex, Inc.:
So I'll take the last one first. There's no impact on the Gen 2 product timing. The mold change, Matt, was a change that we made to improve the manufacturing process of the product. So we were trying to improve its manufacturability quite frankly. And we did all the validation testing. We engineered tested things. As it ramped up and accelerated the volume, we saw a small incidence where the implant would not release after we fired. And just to protect the reputation of this product, we took the decision to pull the product back from the market, put the old molds in and ramp up manufacturing very quickly. The backorder will be resolved by the end of the quarter. And I don't see it having an impact on the growth of NeoTract. And the order rate continues to be very robust for the product. So I see it having – it had an impact of about $1 million in Q2. That will just roll into the last half of the year. But I don't see it having a significant impact or any impact in Q3 or Q4 except for a modest backorder during the Q3, and probably a heavier ramp to the back end of Q3 than we normally have.
Matthew O'Brien - Piper Jaffray & Co.:
Very helpful. Thank you.
Operator:
And our next question comes from the line of Isaac Ro from Goldman Sachs. Your line is now open.
Isaac Ro - Goldman Sachs & Co. LLC:
Good morning, guys. Thank you. Just one more question on the distributor dynamic that we went over here earlier in the call. Can you give us a sense as to whether or not your distributors are effectively running with just lower levels of inventory on an ongoing basis? And to the extent that's something that's actually been happening, what's your best sense of where we're going from here? Just trying to figure out whether there is a change in behavior there on the part of your distributors.
Liam J. Kelly - Teleflex, Inc.:
So it's hard for us to see what our distributors' working capital assessments are. I can tell you, Isaac, that in this instance, this was simply timing. It was just the fact that the July 4 holiday fell on a Wednesday. And given the fact that it fell on the Wednesday, people didn't bridge – that people normally take a couple of days off. They didn't bridge the Monday, Tuesday. They bridged the Thursday, Friday. So they normally place orders on the Friday in order to have the product in as people are on vacation. And it was just simply a timing issue in this regard. As I've said, we saw well in excess of $3 million above our expectation in the first week of July. It was just a one-week timing, and we expected to see it reflect itself in our expectations in the third quarter.
Isaac Ro - Goldman Sachs & Co. LLC:
Okay. And this is a follow-up on UroLift. The molding dynamic you talked about, will there be any noticeable impact to gross margin there, either transient or maybe more prolonged? And I appreciate it's a smaller part of the business, but curious if it's something we should be thinking about as we update our models. Thank you.
Liam J. Kelly - Teleflex, Inc.:
So I'll ask Tom, because Tom did mention that in his remarks.
Thomas E. Powell - Teleflex, Inc.:
Yeah. So, during the quarter we incurred cost of about $2.7 million which impacted margins by about 50 basis points in the quarter. Depending on resolution and how easy it is to rework some of the product that was in inventory, if it is reworkable that would be the end of the costs. If not, there would be additional charges in the third quarter.
Isaac Ro - Goldman Sachs & Co. LLC:
Okay. Thank you.
Thomas E. Powell - Teleflex, Inc.:
Again, we have rolled those expectations into our forecast.
Isaac Ro - Goldman Sachs & Co. LLC:
Got it.
Operator:
Thank you. And at this time, I'm showing no further questions. I'd like to turn the call back over to Jake Elguicze for any closing remarks.
Jake Elguicze - Teleflex, Inc.:
Thanks, operator, and thanks, everyone, for joining us on the call today. This concludes the second quarter 2018 earnings conference call.
Operator:
Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program and you may all disconnect. Everyone, have a great day.
Executives:
Jake Elguicze - Teleflex, Inc. Liam J. Kelly - Teleflex, Inc. Thomas E. Powell - Teleflex, Inc. Anthony Petrone - Jefferies LLC
Analysts:
Isaac Ro - Goldman Sachs & Co. LLC Lawrence Keusch - Raymond James & Associates, Inc. Jaypreet S Chadha - Morgan Stanley & Co. LLC Richard Newitter - Leerink Partners LLC Brian David Weinstein - William Blair & Co. LLC David L. Turkaly - JMP Securities LLC Matthew Mishan - KeyBanc Capital Markets, Inc. Mike Matson - Needham & Co. LLC Kristen Stewart - Deutsche Bank Securities, Inc.
Operator:
Good day, ladies and gentlemen. Welcome to the Teleflex First Quarter 2018 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, there will be a question-and-answer session and instructions will follow at that time. As a reminder this conference call is being recorded. I would now like to turn the conference over to Jake Elguicze, Treasurer and Vice President of Investor Relations. Sir, you may begin.
Jake Elguicze - Teleflex, Inc.:
Thank you, operator, and good morning, everyone and welcome to the Teleflex, Incorporated first quarter 2018 earnings conference call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder this call will be available on our website and a replay will be available by dialing 855-859-2056 or for international calls, 404-537-3406, passcode 2698233. Participating on today's call are Liam Kelly, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks and then we'll open up the call for Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are in fact forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include but are not limited to factors referenced in our press release today as well as our filings with the SEC, including our Form 10-K which can be accessed on our website. With that, I'd like to turn the call over to Liam.
Liam J. Kelly - Teleflex, Inc.:
Thank you, Jake, and good morning, everyone. It is a pleasure to once again have an opportunity to speak with the investment community regarding Teleflex. And I am pleased to report that we are off to a solid start in 2018. The results achieved in quarter one, along with our projections for the remainder of the year, allow us to reaffirm many of our previously provided financial guidance metrics while also affording us an opportunity to increase a couple of others, including our full year adjusted earnings per share range. And while Tom will go into more details on our full year EPS guidance range, I would like to take a moment to discuss our full year revenue guidance. We are pretty pleased to reaffirm our full year constant currency revenue guidance range of between 12% and 13%, as well as our full year organic constant currency revenue growth range of between 5% and 5.5%. I remain confident in our ability to achieve both of these ranges based on the anniversary of the Surgical product line exit, combined with the easier European comparable in the second half of the year, as well as the NeoTract acquisition being counted as organic revenue in the fourth quarter. I'm also pleased to say that due to the favorable FX environment, we are raising our as-reported revenue growth guidance by 1% on both the low and high-end of the range. I would also like to point out that we expect the percentage of revenue generated in quarters two and three to mirror the quarterly percentages achieved in 2017 when we achieved approximately 25% in both quarter two and quarter three, with the remainder generated in quarter four. Turning now to the first quarter, and beginning with revenue. During quarter one, we generated as-reported revenue growth of approximately 20% and constant currency revenue growth of approximately 15%. The constant currency revenue growth increase was broad based and represents a mixture of both improvement in the company's organic growth rate as well as the contributions received from the acquisitions of NeoTract and Vascular Solutions. Starting with the organic revenue growth drivers. During quarter one, we saw a recovery in distributor purchasing patterns that negatively impacted us during the fourth quarter of 2017. You may recall that on our last earnings call, we stated that distributor buying can at times be uneven and that we expected inventory levels held at certain U.S.-based distributors to normalize during the first half of the year. Well, that is what happened in quarter one, and this helped accelerated our organic shipping day adjusted constant currency revenue growth rate to 3.1%. Other areas in which we saw good organic revenue growth were in the segments of Interventional North America, Vascular North America, and Asia Pacific. One segment, however, that experienced a decline in constant currency revenue growth was our Surgical business, and this was largely attributable to our exit of certain low growth, low margin products beginning in the third quarter of 2017. Had we remained in these categories and revenues simply remained flat versus the year-ago period, our organic revenue growth would have been higher by approximately 60 basis points. That said, we know that our exit from these products will have a positive long-term effect on our business. Turning to M&A, NeoTract continues its strong momentum, as global revenue during the quarter totaled $42.3 million, which is an increase of approximately 87% versus the prior year period. We continue to see an increase in the adoption of the UroLift product and we also continued to expand the number of covered lives from an insurance perspective as we are now up to approximately 240 million, thanks to the positive decision issued recently by the Blue Cross Blue Shield Association. And lastly, as it relates to NeoTract, we recently published the results from a retrospective study which confirms the clinical results from our previously published five year L.I.F.T. study. Moving to Vascular Solutions. During quarter one, revenues reached $47.7 million. It is important to understand that we completed this acquisition in mid-February of last year, and as such, only half a quarter of VSI revenue appeared within Teleflex's financial statements during the first quarter of 2017. If you were to compare the full three months of VSI revenue from the first quarter of 2017 to the first quarter of 2018, VSI revenue increased approximately 10% on a shipping-day-adjusted basis. In addition to generating good year-over-year growth, VSI revenue growth performance in the quarter was also an improvement on a sequential basis. As a reference point, assuming our quarter one results included a full three months of organic growth for both NeoTract and Vascular Solutions, then our pro forma quarter one 2018 organic growth adjusted for shipping days would have been approximately 6.6%. This clearly shows the power that both Vascular Solutions and NeoTract can have on Teleflex's organic constant currency revenue growth rate going forward. In addition to getting off in the right direction to begin the year from a revenue perspective, we also continue to deliver solid margin and adjusted earnings per share expansion in the quarter, as we increased our adjusted gross margin by about 190 basis points, our adjusted operating margin by 60 basis points, and our adjusted earnings per share by 19.4%. Finally, we recently initiated a new restructuring program which should allow us to continue to drive nonrevenue-dependent margin expansion in the future. With that as an overview, let's now look at quarter one results in a bit more detail. First quarter 2018 revenue totaled $587.2 million and increased 14.6% on a constant currency basis. Beginning with the components of organic revenue growth, during quarter one, we saw organic constant currency revenue growth of 1.8%. We had one fewer shipping day in the first quarter of 2018, and this caused a headwind to revenue growth of approximately 1.3%. So, on a day-adjusted basis, we estimate our organic constant currency revenue growth was approximately 3.1%. This day-adjusted organic growth consisted of 1.6% from legacy product volumes, 1.5% from new products, and positive pricing adding about 60 basis points. These positive contributors to day-adjusted organic constant currency growth were partially offset by the Surgical Products exit which negatively impacted quarter one growth by about 60 basis points. Moving to the contribution we received from acquisitions. NeoTract added 8.3%, Vascular Solutions added 4.2%, and other M&A added another 30 basis points to our constant currency growth for the quarter. Next, I would like to provide some additional details surrounding our segment and product related constant currency revenue growth drivers. Vascular North America first quarter revenues increased 4.9% on a constant currency basis to $83 million. When normalizing for the shipping day impact, we estimate that Vascular revenues would have increased by 6.5%. The increase in Vascular constant currency revenues was all organic and was due to an increase in new product sales and higher sales volume of existing products during the quarter. During the quarter, PICC revenues were particularly strong, growing approximately 20% versus the first quarter of 2017. Moving to Interventional North America. First quarter revenue was $60.2 million, which is an increase of approximately 50.6% on a constant currency basis. The increase is primarily the result of the addition of Vascular Solutions. When normalizing for the impact of M&A and shipping days, we estimate the organic revenue growth within our Interventional segment would have been 8%. Turning to Anesthesia North America. First quarter revenue was $50.6 million which is an increase of 4.7% on a constant currency basis versus the prior year period. When normalizing for the impact of M&A and shipping days, we estimate that organic revenue growth within our Anesthesia segment would have been 4.4%. The improvement in Anesthesia revenue was due to an increase in new product sales and higher sales volume of existing products. Shifting to our Surgical North America business. Its revenue decreased 11.7% on a constant currency basis to $40.7 million. When normalizing for the shipping day impact, we estimate that Surgical revenues would have declined 10.2%. The decrease in Surgical revenues was primarily due to our exit of a lower margin product line in the third quarter of 2017 that I referenced earlier. As we look forward into the remainder of 2018, we expect that our Surgical business will continue to report negative constant currency revenue growth for the second quarter of the year because of the difficult comparison. However, comps eased in the second half of 2018 thereby allowing for a modest positive constant currency revenue growth in the second half of the year. Moving to our overseas operations. First quarter EMEA revenues were up 4.6% on a constant currency basis to $159.9 million. Within this growth rate, M&A contributed approximately 2.3%. When normalizing for the impact of M&A and shipping days, we estimate that organic revenue growth within this segment would have been 3.2%. Turning to Asia. Our first quarter revenue increased 9.1% on a constant currency basis to $58.2 million. Within this growth rate, M&A contributed approximately 3.5%. When normalizing for the impact of M&A, organic revenue growth within this segment was 5.6%. Shipping days did not have any impact on this segment. Organic growth in this segment was led by China whose revenues expanded 26%. This was largely driven by an increase in volume, following our decision to take our business direct last year. Next, I'd like to brief you on our OEM segment. During the first quarter, revenue was up approximately 2.9% on a constant currency basis and reached $45.8 million. When normalizing for the shipping day impact, we estimate that the increase in OEM revenues would have been 3.3%. The increase in OEM revenues was all organic and was due to higher sales volumes of existing products. And lastly, first quarter revenues for the businesses within our All Other category was up 85% on a constant currency basis, totaling $88.8 million. Growth here is primarily attributable to the acquisition of NeoTract and, to a lesser extent, with Surgery product sales which grew approximately 3.6%. That completes my comments on our segment revenue performance, I would now like to briefly update you on the status of GPO and IDN awards as well as some recent clinical announcements. Beginning with GPO and IDN, during the first quarter, we won an additional nine new GPO and IDN agreements and extended six others. Of the agreements won and extended in quarter one, six were sole-sourced in nature and covered a wide variety of clinical areas including our PVC catheters, laryngeal masks, laryngoscopes, pain pumps, and humidification product offering. We are encouraged by our continued success in this area, and it reinforces our view of sustainability of our revenue generation. Next, I would like to provide you an update on two clinical studies that were recently published as well as an update on RePlas. The first clinical study involves NeoTract. And it is our belief that the data from this study further supports our thought that the UroLift System continues to prove itself as the new standard of care for men with enlarged prostate. On May 19, we announced the results from the first analysis of a retrospective registry of more than 800 UroLift System procedures performed at seven centers in North America, Europe and Australia. The study found that the UroLift System offers significant improvement in symptoms and quality of life through 24 months among patients in the real world, nonclinical setting. With a 40% reduction in IPSS score at 24 month, results were consistent with the data from the randomized five year L.I.F.T. study which shows a high tolerable minimally-invasive procedural experience, rapid reduction of symptoms after the procedure and sustained improvement in quality of life scores, IPSS and peak urinary flow rate while preserving sexual function. Additionally, the registry included patients in urinary retention who required a catheter to urinate prior to treatment. Of those with follow-up data, 96% could urinate without the use of a catheter within the first month following the UroLift procedure. The ability to get men in retention on the catheter is a big milestone in urology. We anticipate that the registry will continue to enroll additional sites and it is expected to increase to more than 2,000 patients. The second study that I would like to talk to you about this morning involves the LMA Gastro. In the February edition of the British Journal of Anesthesia, the LMA Gastro Airway with Cuff Pilot Technology was affirmed to yield a high airway insertion success rate and endoscopy success rate when using in patients undergoing an endoscopic procedure. The prospective study which involved 292 patients sought to determine the efficacy of the LMA Gastro in patients undergoing upper endoscopy and concluded that the endoscope and LMA Gastro insertion success rate was 99%, thereby indicating efficacy. This is important because according to the 2009 study, more than 6.9 million upper endoscopies are performed in the U.S. each year, and the use of moderate to deep sedation during endoscopy is a common practice. Respiratory depression from sedative drugs and airway obstruction requiring intervention are known risks associated with these procedures, with studies demonstrating that in 11% to 50% of cases, patients can become hypoxic. Today, many of these procedures are undertaken without an airway management device in place. The LMA Gastro is the first laryngeal mask specifically designed to enable clinicians to proactively manage their patient's airways by facilitating direct endoscopic access via the integrated channel. We continue to see an increase in the adoption of this product globally and we anticipate the findings of this independent study would further aid in the adoption of this product moving forward. Next, I would like to provide you with a brief update on RePlas. As you may recall, in December of 2017, the FDA and the Department of Defense launched a joint program to expedite the approval of medical products that are intended to save lives in the U.S. Military including freeze-dried plasma. Members of our Vascular Solutions biologics group had a meeting with the FDA in early January, and the FDA confirmed an accelerated biologics license application approval pathway, and confirmed that an efficacy study must be ongoing at the time of the licensure. Following this initial meeting, we met again with the FDA in early April. Like the first meeting, the most recent discussions went well and provided our team an opportunity to inform the FDA about our manufacturing process and validation plan. Following the meeting, there are no changes to our anticipated timeline for RePlas, and we continue to expect a BLA submission in early 2019. And before I turn the call over to Tom, I'd like to share some details with you regarding another restructuring plan that was recently approved. Over the past several months, we have been evaluating opportunities to further improve our operating leverage, and the plan we announced today is designed to further enhance our competitive position. These types of announcements are never easy, and we only make these decisions after very careful consideration. It is our intention to speak with affected employees shortly. I realize that this may be an unsettling time for Teleflex employees, as they hear the news of a new restructuring program. And I would like to take a moment to thank all of the affected employees for their hard work and dedication and to share my commitment that we will treat you in a fair manner as we move through this process. Like previous plan, our new effort is focused on the relocation of certain manufacturing operations to an existing lower cost location, the outsourcing of certain distribution operations and related workforce reduction at certain of the company's facilities. Importantly, this is not something that will happen overnight. Rather we expect certain actions to commence in the second quarter of this year, and that these actions will be substantially completed by the end of 2024. From a financial standpoint, we estimate that we will incur aggregate pre-tax restructuring and restructuring-related charges in connection with the plan of between $102 million and $133 million, of which between $55 million and $72 million will be incurred in 2018. We currently expect that this plan will achieve annualized savings of between $25 million and $30 million when it is fully implemented and that we will start realizing some very minor savings beginning in 2018. Given that we have not yet had an opportunity to speak with the impacted individuals in site, we will not be going into more specifics at this time. That takes me to the end of my prepared remarks. Now I would like to turn the call over to Tom for a review of our financial results for the first quarter and our updated financial guidance for 2018. Tom?
Thomas E. Powell - Teleflex, Inc.:
Thanks, Liam, and good morning, everyone. Given the previous discussion of the company's revenue performance, I'll begin at the gross profit line. For the quarter, adjusted gross profit was $332.6 million versus $267.1 million in the prior year quarter or an increase of 24.5%. Adjusted gross margin was 56.6%, a 190 basis point increase when compared to prior year period. The expansion in adjusted gross margin reflects the impacts of the acquisitions of Vascular Solutions and NeoTract, favorable fluctuations in foreign currency exchange rates, and the favorable impact of cost improvement initiatives. Adjusted operating margin improved 60 basis points to 24%. The improvement was related to the gross margin flow through, however, this was partially offset by the inclusion of NeoTract which currently operates at a higher OpEx cost structure. Adjusted net interest expense increased to $25.7 million versus $15.1 million in the prior year quarter. The increase reflects the impact of additional borrowings required to finance the acquisitions of Vascular Solutions and NeoTract. Turning to the adjusted tax rate. For the quarter, it was 12.8% versus 16.1% in the prior year period. The year-over-year decline is due to a larger tax windfall benefit this year versus last year and the impact of the recently enacted Tax Cuts and Jobs Act. Moving to the bottom line, first quarter adjusted earnings per share increased by 19.4% to $2.15. So, clearly, first quarter adjusted EPS outperformed our prior expectation. The favorable result is attributed to the following factors. First, favorable exchange rates resulted in upside to revenue that flowed through to a modest EPS upside. Second, during the quarter, the tax windfall benefit from share-based compensation was favorable versus our original 2018 budget assumption. Third, we had favorable OpEx spending in the first quarter. The favorability was in part due to better expense control and in part due to a rephasing of expense timing. Our 2018 operating margin guidance of 26.1% to 26.5% had assumed a level of full year spending and we still expect that level of spending. However, the timing will play out a little bit differently versus our original expectation. Additionally, given the strong first quarter earnings results, we now intend to spend a little bit more in OpEx on a full year basis to accelerate future top line growth. The additional spending would be to fund accelerated regulatory approval of RePlas following the favorable meeting with the FDA and to accelerate the timeline for UroLift regulatory filings in Asia and to accelerate sales force hiring plans for NeoTract in the U.S. Overall, if you exclude the favorable benefits from exchange rates, taxes, and expense timing, Q1 results were largely in line with our internal operational expectations. Turning now to select balance sheet and cash flow highlights. During the first quarter, cash flow from operations totaled $87 million, down approximately 4% over the prior year period. The decrease was primarily due to changes in working capital. And then finally, during the quarter, our gross debt balance declined by approximately $18.5 million, reflecting modest term loan repayments, while leverage for our credit facility definition stood at 3.4 times. And that completes my comments on the first quarter. Now I'll move to 2018 guidance updates, beginning with revenue. For 2018, we are reaffirming our full year constant currency revenue growth guidance range of between 12% and 13%, and we continue to expect our organic revenue growth will be between 5% and 5.5%. However, because of an improved outlook for foreign currency environment, we are raising our as-reported revenue growth guidance from a range of between 14% and 15% to a new range of between 15% and 16%. Based on our updated currency assumptions, this translates to an as-reported revenue range of between $2.468 billion and $2.490 billion. We are also reaffirming both our previously provided adjusted gross margin guidance range of 57.5% to 58% and our adjusted operating margin guidance range of 26.1% to 26.5%. Our full year 2018 adjusted tax rate guidance range remains 15% to 16%, although we now expect to be near the lower end of that range. On the bottom line, our outlook for 2018 adjusted earnings per share has improved by $0.15 per share to a range of between $9.70 and $9.90, up from our previous outlook of between $9.55 and $9.75. The revised range represents adjusted EPS growth of between 15.5% and 17.9%. The increase in our adjusted earnings per share guidance is primarily due to improvements in our outlook for foreign currency, including the modest FX upside realized in the first quarter. And on a GAAP basis, we have now included the estimated impact of the 2018 footprint realignment program. Accordingly, the GAAP EPS range has been revised to $5.45 to $5.55 versus $7.10 to $7.20 previously. And so to summarize, Teleflex is off to a good start in 2018. First quarter revenue and adjusted EPS were favorable versus our expectations. Margin expansion was in line with expectations, and the integrations of NeoTract and Vascular Solutions remain on schedule. Lastly, we look forward to sharing our longer-term strategy and financial outlook with the investment community at our Analyst Day event which will take place next week on May 11 in New York City. And that concludes my prepared remarks. Now I'd like to turn the call back over to the operator for Q&A. Operator?
Operator:
Thank you. Our first question comes from Isaac Ro with Goldman Sachs. You may begin.
Isaac Ro - Goldman Sachs & Co. LLC:
Hey. Good morning. Thanks for taking the question. So, just on UroLift, hoping you could put a little more detail on the magnitude of investment you're putting into the channel. I think you gave us a little bit there but would appreciate, in dollar terms, how we should think through the next 12 to 24 months.
Liam J. Kelly - Teleflex, Inc.:
So, I think that as we see NeoTract perform exceptionally well, modestly ahead of our internal expectations, we see the opportunity to solidify the out-years growth. So, our original plan, as you know, was to go from $50 million (30:20) in 2016 to $70 million (30:21) in 2017. We went above that in 2017 and we were expecting a similar cadence. We think that we will add in the region of five to seven additional sales people in this year, even above our original plan, to continue to accelerate the growth. The product is doing exceptionally well, I got to say. I spent a day in the field in the last two weeks viewing some cases myself. And to see the impact on patients is quite significant and to see how enthusiastic urologists are to use this product also had a fair impact on me to see that. So, a lot of enthusiasm and we're looking forward to having two urologists at our Investor Day that are actually going to speak specifically to the UroLift on that day.
Isaac Ro - Goldman Sachs & Co. LLC:
Got it. And just to follow up on the freeze-dried plasma, could you maybe remind us how you're thinking about the size of the opportunity and what the margin impact would be once you get that business up at scale? Thank you.
Liam J. Kelly - Teleflex, Inc.:
Yeah. So, we think that the overall market for freeze-dried plasma is approximately $100 million. About a quarter of that is in the military and we'll obviously begin in the military segment given that they have helped us to develop this product and doing the clinical studies. As I said in my prepared remarks, we now believe that the product will be ready for submission for (31:45-31:58) but we anticipate to get our piece done and get it submitted. The margins, we haven't quantified yet. We're still in discussions with the military as to what the price point (32:06-32:19).
Jake Elguicze - Teleflex, Inc.:
Operator, I think we can take the next question.
Operator:
Our next question comes from Larry Keusch with Raymond James. You may begin.
Lawrence Keusch - Raymond James & Associates, Inc.:
Hi. Good morning, everyone. Liam, just to continue on with UroLift, you also talked about accelerating or I should say investing additional dollars for Asia approval. So, could you walk us through a little bit what countries you're thinking there and sort of timelines to get there?
Liam J. Kelly - Teleflex, Inc.:
Thanks, Larry, and good morning. Yes. So, as you know, we've already submitted for Japan and that's already within our sphere. We have a direct channel within Australia which is also within our APAC region. The new regions that we're looking at, we're looking to accelerate our registrations in China, Singapore, and in Taiwan. So, we think that there are nice significant market opportunities there and we would like to get the product registered earlier than our original expectations. Now, in some of these areas, it will take a longer period of time. So, Singapore and Hong Kong will be very quick. Larry, we should get registrations by the end of the year for those. The other geographies will take anything from one to two years. One thing we're working with, with the CFDA is to investigate whether we can use the U.S. clinical data for the submission, and that's why we're trying to accelerate this process to get a clearer understanding as to whether we will need a Chinese clinical study or whether we can use the U.S. data.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Perfect. And just on that, just to be clear on Japan, what's the start there for timing? And then I just had two other quick questions.
Liam J. Kelly - Teleflex, Inc.:
Yes. Sure. So, we submitted – so the normal timing to get the (34:17) registration is in the region of about 18 months, and then it takes 12 to 18 months to get the reimbursement thereafter. So, that's the normal timeline we would expect, Larry. As we get updates, we'll keep the investment community informed.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Perfect. And then two other quick ones for you, maybe for Tom. If you could just talk about the revised gating on your spending since it sounds like you had a little bit of an underspend in 1Q. And then I guess back to Liam on the distributor restocking, you indicated that you had anticipated that to normalize in the first half. So, I'm just wondering how to think about the activity in the first quarter and what that may mean for the 2Q and also if you could speak to any flu benefit in this quarter. Thank you.
Liam J. Kelly - Teleflex, Inc.:
So, I'll take the second question first, Tom, if you don't mind. So, I'm glad to report, Larry, that we did see the restocking we got from the big three about a $3 million pickup. And as you know, it was about a $3.8 million destocking in the prior quarter. And you could see that in particular in the growth rate within our anesthesia and respiratory business. The respiratory business grew by 3.6% and the anesthesia business grew by 4.9%. So, we did see the rebound in those two businesses and we also saw the restocking from distributors to the tune of about $3 million. Unfortunately, we see this from time to time with distributors' buying patterns outside of our controls, and again, we normally see this come back. We did see a good strong flu season, Larry, and that I think is probably reflected in the growth of those businesses as well as the growth within our Vascular business which grew by 6.9%. So all in all, I got to say, I'm really happy with the first quarter and the results that we achieved from our core businesses, the contributions of VSI, the contributions of NeoTract and I think we're off to a real solid start for the year. Tom.
Thomas E. Powell - Teleflex, Inc.:
And then on the rephasing, as mentioned in the first quarter, part of the upside was due to just better expense management, part of it was due to moving some spend out into subsequent quarters and really the rationale was that these new opportunities to invest behind RePlas, and NeoTract were emerging. We wanted to see how the first quarter turned out to see how much we could afford to pull in and move forward and, thankfully, the first quarter results turned out pretty good. And so, as you look at the balance of the year, you shouldn't assume there's any one quarter where the bolus of that spend is. In fact, it's a couple of billion dollars that's actually being moved out and part of the upside in OpEx in the first quarter will be used to fund some of these additional investments. But as mentioned, in the aggregate, we still expect to spend the same full year amount that was in the plan and then a little bit more given these investments that we've spoken about. Hopefully, that helps but I wouldn't expect it to be a large increase in any one given quarter.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Perfect. Thanks, guys.
Operator:
Thank you. Our next question comes from David Lewis with Morgan Stanley. You may begin.
Jaypreet S Chadha - Morgan Stanley & Co. LLC:
Hi. Good morning. This is Jay Chadha in for David. Congrats on the quarter.
Liam J. Kelly - Teleflex, Inc.:
Thank you.
Jaypreet S Chadha - Morgan Stanley & Co. LLC:
Organic growth, first question, sequentially was encouraging. Can you talk about how you see the outlook from here?
Liam J. Kelly - Teleflex, Inc.:
Yeah. I think we expect to see an accelerating growth organically for our business. I mean, our constant currency guidance is 5% to 5.5%. Our constant currency days adjusted for the quarter was 3.1%. Within the 3.1%, we saw solid volume, good new product revenue, good pricing. So, I'm really, as I said earlier, pleased with the results. And, again, our pro forma revenue growth in the quarter was 6.6% days adjusted. So, now to get to our 5% to 5.5% from quarter two onwards, we will have a full quarter of the VSI growth in our organic growth. In the second half of the year, we will learn the anniversary the surgical excess. And in quarter four as well as an extra billing day, NeoTract rolls off being accounted as organic. And we'll add, as we said before, 0.5% to our full year revenue. So, you should continue to see it increase ratably over the remainder of the year.
Jaypreet S Chadha - Morgan Stanley & Co. LLC:
Got it. Very clear. Thank you. And a quick follow-up. VSI also recovered this quarter. Can you talk about the recovery you saw and any underlying momentum you're seeing in the business in addition to the benefit from DTD conversions?
Liam J. Kelly - Teleflex, Inc.:
Yeah. So, you would see that in our positive pricing. So, we were very pleased with the results from our dealer to direct. We've executed very well on that and our European team should get great credit for that. I got to say I was really pleased to see VSI come with a double-digit days adjusted growth rate. It came in at 10%. And I would also expect that now as we begin to execute on the go-direct, that we should see a modest improvement in VSI over the remainder of the year also.
Jaypreet S Chadha - Morgan Stanley & Co. LLC:
Thank you.
Operator:
Thank you. Our next question comes from Richard Newitter with Leerink Partners. You may begin.
Richard Newitter - Leerink Partners LLC:
Hi. Thanks for taking the questions. I have a couple. Maybe just on the restructuring, can you give us any sense as to the cadence of that $25 million to $30 million in pre-tax annual savings? When do you think we'll start to see that factoring into the P&L? And I know through 2024 is the time period but that's a long window. When will we start to see the kind of lion's share of that benefit? And on that, can you just maybe remind us of what's left on your existing restructuring? Thanks.
Liam J. Kelly - Teleflex, Inc.:
So, I'll ask Tom to go over that, if you don't mind, Rich.
Thomas E. Powell - Teleflex, Inc.:
Yeah. And we'll go into this in more detail next week at Analyst Day. But it is a long-lived project and you shouldn't expect to see the lion's share until kind of the early 2020s is when we'll start to see meaningful savings. So, there are some steps that have to be taken first and that's the reason for the lengthy timeline. As for the other restructuring programs that are still outstanding, we have disclosed a total of $76 million to $90 million outstanding and I would say that about half of that had been realized by the end of 2017. So, there's still meaningful savings out there on the existing programs and the majority of that saving will be realized over the next couple of years 2018, 2019, and 2020.
Richard Newitter - Leerink Partners LLC:
Okay. Thanks that's helpful. And then just going back to UroLift, very, very strong quarter for NeoTract again, and I appreciate so many investments coming up. But you have a competitor that just recently got acquired by a large med-tech player and I'm just curious about your thoughts on that technology as it kind of moves into the hands again of a company with bigger resources and could make an investment on the category. How does the increased investment potentially factor into kind of that move, if at all? How do you see the market playing out? And any comparisons between the two technologies would be helpful. Thank you.
Liam J. Kelly - Teleflex, Inc.:
So, Rich. Yeah. Obviously, we're aware of the acquisition of NxThera by our competitor. I think what probably underappreciated about Teleflex is the amount of sales force that we actually have globally within that urology call point. So, Teleflex would have in excess of 200 salespeople calling on that urologist on a daily basis and we have a dedicated sales team with the UroLift product which is also calling predominantly on doctor's offices and AFCs (42:34) which is where the product has been moving to. 60% of our revenues for NeoTract, Rich, are coming from outside of the hospital area. That really fits into what healthcare providers are trying to do. Now, the BPH is a massive space which we never thought that we would be in the BPH space on our own. But what we are determined to do is make sure that UroLift is a standard of care. Our view is that the patient outcomes will win out seven days a week and twice on Sundays. And we feel that we have had a much better patient outcome with our products. Our product is minimally invasive. Less than 20% of the patients require a catheter. The results are immediate. We don't ablate any tissue and the next tier of product – every other technology ablates tissue and if you burn and cut, therefore, naturally, you're going to have bleeding or swelling. And also, I mean, a big one for us is – and it's borne out by the clinical study I just spoke about, it's borne out by the L.I.F.T. study, zero infection with dysfunction. If you're actually cutting, you have a risk of sexual dysfunction and the clinical papers have pared that out. So I think that we're really confident in our technology. We never thought we'd be there on our own, Rich, but by gosh, we want to make sure that we're the number one and we are the standard of care and that's our goal.
Richard Newitter - Leerink Partners LLC:
Okay. Thanks. Maybe just one last follow-up. Liam, you said that of the $3.8 million of kind of distributor impact from the fourth quarter, you got back about $3 million in the first quarter. Does that mean that we should be thinking about just under $1 million coming back hopefully in the second quarter?
Liam J. Kelly - Teleflex, Inc.:
Yeah. Well, it normally comes back, Rich. So I don't see any reason that it wouldn't. I mean, it's not a big number on a full year basis, but I would anticipate that we would see less destocking at the end of quarter two and mid quarter three. That would be my expectation, yes, but I'm glad that the bolus of it came back in the first quarter because that's what I expected.
Richard Newitter - Leerink Partners LLC:
Excellent. Thank you.
Operator:
Thank you. Our next question comes from Brian Weinstein with William Blair. You may begin.
Brian David Weinstein - William Blair & Co. LLC:
I wanted to first start with a higher-level question related to share gains. In the past, you guys have talked about approximately 125 basis points of growth coming from this source. Maybe you could update us on how this is tracking according to plan and provide some specific areas on why this has worked and maybe a few areas on why it's falling short. Thanks.
Liam J. Kelly - Teleflex, Inc.:
Could you just clarify – sorry, the line wasn't that clear, Brian. So 125 basis points is coming from...
Brian David Weinstein - William Blair & Co. LLC:
Share gains.
Liam J. Kelly - Teleflex, Inc.:
So, share gains in – we didn't make any statement about 125 basis points of share gains. Coming from which segment, Brian?
Brian David Weinstein - William Blair & Co. LLC:
Yeah. We just had in our notes that over kind of your longer-term plan growth, you were expecting some level of growth from share gains. Maybe as a more broader question you could talk about what you're seeing in terms of these gains in specific segments.
Liam J. Kelly - Teleflex, Inc.:
Absolutely. So, I think that as I said during my prepared remarks, we see share gains in many areas of our business. One that's particularly encouraging for me is the PICC segment. We grew by over 20% in the key North American market in the PICC segment, and we're very comfortable that we're taking share there. I think in the interventional segment that grew by 8% in the quarter. We continue to see strength within our interventional business. In our anesthesia business, we saw a really solid rebound in our anesthesia business, and we continue to do well within our laryngeal mass, within our blades, and within our pain pump area of our business. Overseas within the EMEA business, I think we're doing particularly well in our surgical business in Europe where we don't have the impact of the exit from that lower margin, lower growth segment. And obviously within China, as a result of our decision to go direct, we saw a 26% growth in the quarter in China, and we also saw China and our Asia-Pacific in general perform very, very well. So, there are some broad areas of where we see ourselves as taking nice share gains, Brian.
Brian David Weinstein - William Blair & Co. LLC:
Great. Thanks. And then secondly, more specifically on the quarter, can you talk about trends in Latin America and some of the emerging markets? Thanks.
Liam J. Kelly - Teleflex, Inc.:
Yeah. So, as I began giving some comments on Asia and we saw a really solid rebound within Asia, the Latin American business traditionally has been a drag for us. We saw 3% in the first quarter. We do see Latin America rebounding modestly. So, that's encouraging because, quite frankly, it has been a drag over the last two years and we have seen either flat or negative growth over the past couple of years. So, as the oil-based economies show some improvement, as the currencies have started to stabilize, we're starting to see some encouraging signs there. And also in the Middle East and Russia, we've seen a modest rebound as well in those emerging segments. So, we're quite encouraged by the trends that we see there, Brian.
Brian David Weinstein - William Blair & Co. LLC:
Thank you.
Operator:
Thank you. Our next question comes from Dave Turkaly with JMP Securities. You may begin.
David L. Turkaly - JMP Securities LLC:
Good morning. Just to follow-up on some of the PICC commentary you made. Just curious on that market size today and where you stand, I think when you had a competitor that was public, they were the largest player but I was curious if you're gaining share there still maybe even against them and then I know you had some anti-microbial antithrombogenic products. I'm curious as to what percent of your mix those are.
Liam J. Kelly - Teleflex, Inc.:
Okay, Dave. So, of our catheters, over 90% of the catheters that we said in our PVC area or on our PICC area are coated catheters. And that is because the hospitals realized that an infection will cost them $43,000 to treat that patient and they won't get reimbursed. And secondly, if they end up in the bottom tier from a Hospital-Acquired Condition score, they get a lower reimbursement the following year. So the overall PICC market in North America is around $340 million. Our share of that will be – we would be in that $35 million area, call it, on an annualized basis. So we continue to take share gains there. Your question as to who we're taking it from, I mean, there's two main competitors. There is C. R. Bard as they were and there's AngioDynamics. I think that we are in a really strong condition in our coating. We've got a good, better, best from a Tip Positioning technology, and I think all in all, we're really happy with our portfolio. We're really happy that we have these unique coatings that differentiate us in the marketplace, and we continue to expect to take share gains over a multiyear period because of all of those factors.
David L. Turkaly - JMP Securities LLC:
Thanks for all that detail. I know there's been a lot of questions on UroLift, but can you just remind us what rep productivity you think it is at scale? And my last one would just be any update on Percuvance. Thanks a lot.
Liam J. Kelly - Teleflex, Inc.:
Well, I think from a rep productivity, the one statistic that I love is that it takes a urology consultant rep about six to seven months to get up to $1 million in revenue in a new territory. So, as we add additional reps, of course, we don't have as many virgin territories as we had originally, but we do see productivity improving. And if you took our general pool of urology consultants, we're getting about $2 million now on average from each sales rep within that group. And our best reps are over the $3 million range. I mean, I was actually – I said I was out in the field with a rep a couple of weeks ago. That sales rep did over $3 million last year. Now, he's a really, really experienced salesperson and very successful. But the productivity from the reps, we continue to see it grow, and we continue to see adoption of the product. And, again, 87% growth in the quarter on NeoTract was very, very encouraging for us.
David L. Turkaly - JMP Securities LLC:
Thank you.
Operator:
Thank you. Our next question comes from Anthony Petrone with Jefferies. You may begin.
Anthony Petrone - Jefferies LLC:
Thanks. Maybe one for Tom just on earnings guidance. See there's a little bit of an FX benefit, we also have a little bit of restructuring coming in. Obviously, Vascular is getting back a little bit in terms of overall growth and then we have NeoTract. So, maybe just the components of earnings guidance, the adjusted earnings guidance going higher, where you see the most benefit from all of those drivers. And then I have two follow-up product questions. Thanks.
Thomas E. Powell - Teleflex, Inc.:
Okay. So, as we took a look at our results for the first quarter, really as mentioned, the operating results were largely in line with our expectations with a couple of exceptions and those exceptions being favorable foreign exchange environment, the tax rate came in a little bit better, in part due to some favorable rates and in part due to the tax windfall. And then we spoke about the OpEx spend. Some of that was favorable, and some of that was a rephasing. So, as we look at the basis of the raise, really how we're thinking about it is initially when we started the year, we thought foreign exchange would be a tailwind of $0.26. And now, we expect it to be a tailwind of $0.42, so a $0.16 improvement there. The tax rate, as mentioned, given the windfall and a little bit better rate, we now expect to be the lower end of our range and that 50-basis point improvement in taxes is worth I think about $0.06. And so you're up a little bit over $0.20. The OpEx really (53:20) phasing and so we're not going to see any full year benefit. In fact, we're going to do a little bit of investment above the full year previous spend rate. So that's how the upside from tax and windfall gets kind of carved back a little bit and we're dropping through $0.15 cents. So it's really the potential FX as well as tax benefits that are driving the raise.
Anthony Petrone - Jefferies LLC:
Well, I'll stay on this topic for a moment. As we look at the Analyst Day coming up next week, maybe frame the discussion in terms of the adjusted operating margin outlook. And I guess my real question in there is there's one variable that's a potential wildcard and that's RePlas. And so how do you consider now that we have a new restructuring program, new assets within the portfolio, NeoTract, Vascular, how do all of those sort of get factored in? And in particular without having guidance on RePlas, is there a scenario analysis that potentially you will run through with and without RePlas? And then one follow-up product question. Thanks.
Liam J. Kelly - Teleflex, Inc.:
So, on the revenue line, I mean, we'll go into that in more details at our Analyst Day. It's only a week away. We'll give details on RePlas. I mean, we have a few, let me call them, wildcards with potential upside for us in the longer term and RePlas is one of them. Percuvance is another one that has potential there. So, we will give our guidance based on our portfolio but with some commentary on what might assist us, I think, is what you can to expect to see happen.
Anthony Petrone - Jefferies LLC:
That's helpful. And then last for me would be on NeoTract and NxThera, Boston Scientific taking out that asset. My understanding is that the reimbursement for NeoTract is quite a bit more favorable than NxThera. So, maybe just a recap on the reimbursement and how it stands today. Thanks.
Liam J. Kelly - Teleflex, Inc.:
So, the situation, I believe, with the reimbursement for that device is that they have a provisional CPT code. The reimbursement rate will not be determined until early in 2019. So, therefore, the comparable – there is no comparable. I believe a different code had been used in the past, and I believe that they will no longer be using that code because the NxThera device wasn't technically that type of product. So, it's hard to make a comparable as to what their reimbursement is versus NeoTract. What I can tell you is that the NeoTract reimbursement is very favorable for the clinician and very favorable results for the patients. So, we will know more in early 2019, and then I guess they would have to go through the process of bringing on all of the private payers. Just as a point of reference, that took us two and a half or three years to bringing on all the private payers and we're still only up to – no, we're up 240 million lives. We're very encouraged by that, but it took us three years to get to 240 million lives. So I would imagine that Boston will have to follow a similar process than we did to bring on those payers.
Anthony Petrone - Jefferies LLC:
Very helpful. Thank you.
Operator:
Thank you. Our next comes from Matthew Mishan with KeyBanc. You may begin.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Great. Thank you for squeezing me in. I just want to start with Asia. I think most of my questions have been asked. Do you think you have the product registration runway and the infrastructure in place to the point where you can potentially sustain like double-digit growth in that Asia segment moving forward? I mean, you're about – it's a little over 10% sales, and 10% growth would give you about 100 basis points of organic growth moving forward.
Liam J. Kelly - Teleflex, Inc.:
So, our long-term goals for the Asia Pacific region is to get into the high single, low double digits. I think we've been pretty constant on that. With regard to our structure for registrations, in the APAC region, we had significant resources to assist with our registrations, and we always have had. And quite frankly, Matt, you need that in order to be able to do the registrations because you've got to move them into the languages and the CFDA, you got to work with them to define whether you need a clinical study, whether you don't need a clinical study, what the classification of the product is. And, obviously, we continue to make additional investments into China, and we are, this year, making additional investments into Asia in general for the registration of the NeoTract product because we wanted to make sure that we are well positioned to take advantage of that opportunity in the future. And it takes – it can take one to two years to get a registration in China. So, we're acting now to be prepared for two years' time. We're acting in Japan to be prepared for two or so years' time. Well, obviously, Hong Kong and Singapore should be easier, but some of these geographies do take a significant amount of time. And we will be looking then at Latin America in the future to see what our plan is to accelerate the registration there. So, one of the things that I think that Teleflex really brought to the table with the acquisition of NeoTract was that global footprint. And as we said at the time of the acquisition, we would be working to leverage our global footprint to expand this technology into new markets. And that's exactly what we're doing.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Okay. Thanks, Liam. And then on NeoTract, I'm not sure you guys ever really provided a quarterly cadence of last year's results for it. Could you give us a sense of how it was phased through 1Q through 4Q last year so that we don't look at say the 87% increase this year in the first quarter and ask why you didn't raise the guidance of 40% for the year?
Liam J. Kelly - Teleflex, Inc.:
So, I can. I mean, if you go from 1Q to 4Q, so I know 4Q at the top of my head with $39 million, 3Q was about $34 million, 2Q was $30 million and 1Q was about $23 million in that ballpark. So, basically, that's the basis that we're using for the growth over year-over-year. That's where you get your 87%. And the growth rate even over the prior quarter was greater than 8%. So, we've been pretty consistent with the growth rate on NeoTract and we continue to see that.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
All right. Thank you very much.
Operator:
Thank you. Our next question comes from Mike Matson with Needham & Company. You may begin.
Mike Matson - Needham & Co. LLC:
Hi. Thanks for filling me in. Just wanted to start with Vascular Solutions. You gave the sales number. Can you just remind us what that implied in terms of pro forma growth? And is the distributor conversion impact completely behind you now in that business?
Liam J. Kelly - Teleflex, Inc.:
Thanks, Mike. So, I'll start with the distributor. It's completely behind us. We've executed on all of the distributor go-direct in Europe. And as I've said in my prepared remarks, the growth rate was just over 10%. So, again, we're very encouraged by the overall growth rate and it was – it grew sequentially over quarter four. So, all the metrics for VSI are very encouraging for us and we're really enthusiastic about that asset.
Mike Matson - Needham & Co. LLC:
Okay. Thanks. And then, Tom, just curious on your outlook for commodity costs, I mean, we're seeing oil prices increase and there's talk of tariffs on metals and things like that. So to what degree – is that a factor in your costs of goods and at what point would you think that would start to translate in the gross margin pressure, if at all?
Thomas E. Powell - Teleflex, Inc.:
Well, obviously, we're watching the situation too with the cost of PVC and other components and we do see some pluses and minuses. Right now, we're not seeing a major impact, a slight uptick in the inputs. Where we're seeing more of an impact is in labor rates in some of our markets, Mexico and Czech Republic. So we have moved to address compensation levels to the current market. But right now, the commodities haven't had a significant impact. We'll certainly watch that going forward. Labor has had some impact already.
Mike Matson - Needham & Co. LLC:
Okay. And then finally, can you just tell us some selling days for the remainder of the year whether you're up or down versus prior year for each quarter? Thanks.
Liam J. Kelly - Teleflex, Inc.:
Yeah. So quarter two, we've got plus one and then obviously we have one left in this quarter – in quarter one. And then in quarter four, we're plus one again in quarter four, Mike.
Mike Matson - Needham & Co. LLC:
Okay. Great. Thanks a lot.
Operator:
Thank you. Our next question comes from Matt O'Brien with Piper Jaffray. You may begin.
Unknown Speaker:
Thanks for taking the questions. This is Kevin (01:02:42) on for Matt today actually. I wanted to jump back to the revenue guidance for the year quickly if we could. I just wanted to discuss why the team didn't choose to take it up slightly on an organic constant currency basis just given the continued NeoTract strength. Is the company just being conservative here? And should we be modeling closer to the higher end of that range? It sounds like the components of that 5% to 5.5% are unchanged with NeoTract providing 50 bps of growth and VSI at 100. So, just wanted to talk through that decision process to not bring it up a little bit.
Liam J. Kelly - Teleflex, Inc.:
So, we feel very comfortable with our guidance range. I mean, our constant currency guidance range is 12% to 13%. We took off a percent obviously for the impact of currency. NeoTract is running slightly ahead of our internal expectations after one quarter and it is one quarter. So, we feel very comfortable in our guidance range we think our core business had a good solid start into the year at 3.1 %. We think that we'll get a full quarter of VSI in quarter two. We will get an easier comparable in the latter half of the year with the surgical exit. And, of course, we've got an extra billing day. But all of that was in our guidance range, and we gave it at the beginning of the year. We anticipate getting a bounce back from the distributors in quarter one. We anticipate VSI growing – rolling off and all of the other factors. The performance of NeoTract is very encouraging and it's one quarter. So, we're comfortable in our guidance of 12% to 13% at the end of the first quarter.
Unknown Speaker:
Okay. Thanks so much. And then just one more from me. I mean, you guys have been rightsizing the organization and removing some slower growth, lower margin businesses as you said. But there seems to be some larger moving pieces now this year with integrating two large acquisitions and the new restructuring program. So, how do you think about that dynamic for managing the portfolio of some of those businesses? Is it going to be decreasing here in 2018 and something that we should look for a little bit later or how do you think about that dynamics?
Liam J. Kelly - Teleflex, Inc.:
So, with regard to integrating acquisitions, our structure is very beneficial in that regard. So, if you look at the two acquisitions we're integrating, Vascular Solutions is impacting the interventional business unit and the integration of NeoTract is we set it up as a standalone business unit so it wouldn't cause a disruption within the business. With regards to the restructurings, we have a number of restructuring programs that we've been running through in the last number of years and the phasing and the timing of this restructuring announcement is timed as a lot of those resources roll off from the existing restructuring programs to give us bandwidth to do further restructuring. So, we do give a lot of thought to the company bandwidth, management bandwidth in our thought process around restructurings and integrations and we feel that we have sufficient bandwidth to manage all of the projects that we have ongoing at the moment.
Unknown Speaker:
Thanks, Liam. That's helpful.
Liam J. Kelly - Teleflex, Inc.:
Cheers.
Operator:
Thank you. Our next question comes from Kristen Stewart with Deutsche Bank. You may begin.
Kristen Stewart - Deutsche Bank Securities, Inc.:
Hi. Good morning. Thanks for taking the question.
Thomas E. Powell - Teleflex, Inc.:
Good morning.
Liam J. Kelly - Teleflex, Inc.:
Good morning, Kristen.
Kristen Stewart - Deutsche Bank Securities, Inc.:
I'm not sure if I missed this, but I think there was a question on Percuvance earlier. I don't know if you guys gave a response to that and where that stands.
Liam J. Kelly - Teleflex, Inc.:
So, nothing has changed, Kristen. No, we didn't have a question earlier. I'm glad you brought it up actually. So, we're currently on path to submit to the FDA in quarter three and we are on track to get the product laid in quarter four. We will do a 100-patient limited market release late in quarter four and to validate all of the changes that we've made. So, we – and we'll expect to see revenue beginning in 2019.
Kristen Stewart - Deutsche Bank Securities, Inc.:
Okay. Perfect. And then speaking of 2019 just kind of, can you give an update on NeoTract in terms of the accretion? It sounds like just as you had mentioned before, I guess you guys still expect over 40% growth for the year. With the additional investments that you're making, does that change at all the accretion outlook in 2019?
Liam J. Kelly - Teleflex, Inc.:
I'll ask Tom to cover that, if you don't mind.
Thomas E. Powell - Teleflex, Inc.:
Yeah. So, the investments that we're making, really, we don't foresee being an expense burden overall to adversely impact the accretion in 2019. If anything, we should start to benefit from some acceleration in revenue quicker than what's previously envisioned given the sales force addition. So, you should not expect dilution from these investments. Rather, we think it's a longer term upside.
Kristen Stewart - Deutsche Bank Securities, Inc.:
Okay. So, is it upside relative to what you've modeled for the accretion in 2019? Or do you just feel more confident in reaching those goals? I think it was like $0.35 to $0.40 or something like that.
Thomas E. Powell - Teleflex, Inc.:
Well, I think as we get closer to 2019, we'll take the opportunity to provide guidance for 2019. We'll want to see obviously how this year plays out. We're clearly off to a good start in the first quarter. Revenues have come in well, and that's afforded us some opportunity to kind of move some investments around. But before commenting specifically on 2019 guidance, we'd like to get a little bit further to this year and the progression of growth this year.
Kristen Stewart - Deutsche Bank Securities, Inc.:
Okay. Perfect. Thanks again for taking my questions.
Thomas E. Powell - Teleflex, Inc.:
Thank you.
Liam J. Kelly - Teleflex, Inc.:
Thank you.
Operator:
Thank you. Our next question is a follow-up from Larry Keusch with Raymond James. You may begin.
Lawrence Keusch - Raymond James & Associates, Inc.:
Tom, I just want to pick your brain for a moment again on capital allocation and I guess this is also in part for Liam. Just given the integration efforts that you have ongoing right now with Vascular Solutions and NeoTract, what's your ability or comfort to do some additional M&A? And also with your leverage ratio around 3.4 times, I guess, Tom, again the question there is what do you think is a comfortable level for the company in this environment giving rising rates, et cetera?
Liam J. Kelly - Teleflex, Inc.:
So, I'll talk broadly and then I'll pass it to Tom. So, as I said previously, Larry, our goal this year would be to delever. We are anticipating getting our leverage rate down to below 3 times by the end of the year. We would like to get down below 3 times leverage. But as we all know, acquisitions are opportunistic. And as I've said many times, I didn't think that when we did Vidacare in 2013, it would be 2017 before we would do something like Vascular Solutions. And I didn't think when we did Vascular Solutions that within – before the year was out, we'd be doing NeoTract. So it is opportunistic. So, our goal is to delever but having said that, if an opportunistic and very attractive acquisition that was clearly within our (01:10:08-01:10:10) we'd have a long hard look at it.
Thomas E. Powell - Teleflex, Inc.:
Yeah. So, I think I'd agree with Liam's sentiments as he's outlined and, certainly, we'll have to incorporate the current rate environment into our financial analysis to see if any of these acquisitions meet our financial criteria as well as our strategic criteria. But I wouldn't necessarily say that the rising rate environment would take us out of the marketplace.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Terrific. Thanks, guys. See you next week.
Liam J. Kelly - Teleflex, Inc.:
Thank you.
Operator:
Thank you. This concludes the question-and-answer session. I would now like to turn the conference back over to Jake Elguicze for closing remarks.
Jake Elguicze - Teleflex, Inc.:
Thanks, operator, and thanks to everyone for joining the call today. This concludes the Teleflex Incorporated first quarter 2018 earnings conference call. Have a nice day.
Operator:
Ladies and gentlemen, this concludes today's conference. Thanks for your participation. Have a wonderful day.
Executives:
Jake Elguicze - Treasurer & VP, IR Liam Kelly - President & CEO Thomas Powell - EVP & CFO
Analysts:
David Lewis - Morgan Stanley Larry Keusch - Raymond James Richard Newitter - Leerink Partners Matt Taylor - Barclays Matthew O'Brien - Piper Jaffray Anthony Petrone - Jefferies Kristen Stewart - Deutsche Bank Dave Turkaly - JMP Securities Matthew Mishan - KeyBanc Mike Matson - Needham and Company
Operator:
Good day, ladies and gentlemen, and welcome to the Fourth Quarter 2017 Teleflex Incorporated Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions] As a reminder, today’s conference is being recorded. I would now like to turn the call over to Mr. Jake Elguicze, Treasurer and Vice President of Investor Relations. Sir, you may begin.
Jake Elguicze:
Good morning, everyone, and welcome to the Teleflex Incorporated fourth quarter 2017 earnings conference call. The press release and slides to accompany this call are available on our website at www.teleflex.com. And as a reminder, this call will be available on our website and a replay will be available by dialing 855-859-2056 or for international calls, 404-537-3406; passcode 6373419. Participating on today's call are Liam Kelly, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Liam and Tom will provide prepared remarks and then we'll open up the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today, as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. I would also like to point out that following the Company’s acquisition of Vascular Solutions, the Company commenced an integration program under which it is combining the Vascular Solutions business with some of its legacy businesses. Specifically, the Company is combining the Vascular Solutions North American business with the Company's interventional access business, which formerly was part of the Vascular North America operating segment, and the Company's cardiac business, which formerly was a separate operating segment included in the all other category for purposes of segment reporting. These businesses are now in the Company's Interventional North America operating segment. Additionally, the Company is combining the Vascular Solutions businesses in Europe, Asia and Latin America with the Company's legacy businesses in the respective locations, and these Vascular Solutions businesses are now part of the EMEA, Asia and Latin America operating segments, respectively. As a result of the operating segment changes, the Company has the following seven reportable segments
Liam Kelly:
Thank you and good morning everyone. In beginning, I would like to start by saying that during 2017 Teleflex achieved very positive results. These include driving additional operating leverage from our various restructuring initiatives; increasing our adjusted earnings per share guidance range on three occasions, ultimately achieving adjusted earnings per share at the very top-end of our most recently provided range; and completing two large acquisitions that help transform the Company’s constant currency revenue growth profile. And speaking of these acquisitions, our most recent acquisition, NeoTract, exceeded our prior expectations, reaching $39 million of revenue for the fourth quarter and $125.5 million for full year 2017. This translates into revenue growth of 121% for the quarter and 149% for the year. And as we look forward, we as a management team are enthusiastic about what we have accomplished over the past few years, and that the Company is well-positioned for success in 2018 and beyond. Turning to an overview of the fourth quarter, we saw strength from revenue growth associated with new products, which is a continuation of the trend we saw all year. In addition, during Q4 we saw strong shipping-day adjusted constant currency revenue growth within our higher-margin Vascular North America and Interventional North America segments. However, due to some temporary softness, our consolidated revenues in the fourth quarter were modestly lower than what we expected when we last provided guidance in early November. The delta versus our expectations primarily occurred due to two items and it is our belief that they are both transitory in nature. First, within EMEA, we saw lower than normal revenue growth, in part due to distributor conversions associated with our Vascular Solutions product lines. During the fourth quarter, we completed several distributor conversions, and in advance of completing these distributor acquisitions, the distributors did not purchase the typical amount of product that they normally would have had there not been a pending acquisition. I am pleased to report that because we completed these distributor conversions in 2017, we expect an acceleration in revenue growth in Vascular Solutions product lines within EMEA during 2018. Second, during the quarter we saw reduced orders from certain U.S.-based distributors which impacted some of our North American-based strategic business units. It is our belief that this is a timing issue and the primary business units that were impacted were our North American Anesthesia and Respiratory segments. This is something that we’ve experienced previously, and in the past, distributors replenished inventory levels rather quickly. It is our expectation that this will once again occur during 2018. Turning to M&A, as many of you are already well-aware, our two recently completed scale acquisitions will significantly improve our future organic revenue growth rates, and that is expected to begin in 2018. I’ve already spoken a bit about Vascular Solutions and the benefit we expect to receive in 2018 because of our ability to complete certain distributor conversions in late 2017. That, however, isn’t the only growth driver in 2018 for Vascular Solutions, as we also expect to see an acceleration in new product growth. Moving to NeoTract, as I previously mentioned, it was a real highlight for us this quarter as it reached approximately $39 million in revenue. This was considerably better than our initial expectations which called for revenue of between $28.5 to $33.5 million. The Q4 performance, coupled with a recently received FDA clearance for expanded indications for the UroLift system, as well as NeoTract’s ability to obtain additional covered-lives through private payer insurance coverage, gives us further confidence in their ability to drive significant revenue growth for many years to come. Lastly, we continued to deliver solid margin and adjusted earnings per share expansion in the quarter, as we increased our adjusted gross margin by about 270 basis points, our adjusted operating margin by 40 basis points, and our adjusted earnings per share by 14.6%. As Teleflex’s new CEO, I want to emphasize that Teleflex is well positioned to drive consistent constant currency revenue growth, and that our longer-term margin expansion objectives remain fully intact. With that as an overview, let’s now look at fourth quarter and full year 2017 results in a bit more detail. Fourth quarter 2017 revenue was $595.1 million, and increased 15.8% on an as-reported basis and 12.6% on a constant currency basis. As you will see momentarily, the constant currency revenue growth in the quarter was due to the acquisitions of both Vascular Solutions and NeoTract, while our base business fell a bit short for the reasons I mentioned earlier. Despite this, we were still able to achieve fourth quarter 2017 adjusted earnings per share of $2.44, which is an increase of 14.6% versus the prior year period. On a full year basis, revenues reached $2.146 billion and were up 14.9% on an as-reported basis, and 14.1% on a constant currency basis. From an earnings standpoint, we delivered adjusted earnings per share of $8.40, which was at the high-end of our most recently increased guidance range, and an increase of 14.4% versus the prior year. It is also much better than our initial 2017 guidance range which called for adjusted EPS of between $8.00 to $8.15. Next, as is our practice, I would like to take you through the components of our Q4 revenue growth. For the consolidated company, fourth quarter 2017 constant currency revenue grew 12.6%. Beginning with the components of organic revenue growth, during Q4 we saw organic constant currency revenue growth excluding the impact of shipping days expand by approximately 1.8%. This consisted of revenue growth from new products adding 2% and positive pricing adding about 70 basis points, while legacy product volumes were down about 90 basis points. In addition, during the quarter we had 5 fewer shipping days, and this caused a headwind to revenue growth of approximately 5%. Moving to the contribution we received from acquisitions, during the quarter Vascular Solutions added about 8%, NeoTract added 7.4%, and other M&A added another 40 basis points. Next, I would like to provide some additional color surrounding our segment and product-related constant currency revenue growth drivers. Vascular North America fourth quarter revenue increased 0.3% on a constant currency basis to $80.7 million. If you were to normalize for the shipping-day impact, Vascular constant currency revenues increased approximately 8%. The increase in shipping-day adjusted Vascular revenues was largely due to higher sales volumes of existing products, an increase in new product sales, and price increases. And as we think about 2018, it is our belief that this segment will grow constant currency revenues in a similar manner to what was achieved in 2017. Moving to one of our newly created segments, Interventional North America fourth quarter revenue was $61.7 million, which is an increase of approximately 177% on a constant currency basis. Normalizing for shipping days, Interventional constant currency revenue improved by almost 185%, the increase is largely the result of the addition of Vascular Solutions, coupled with continued growth from the Vidacare On-Control bone marrow product line, as well as increased intra-aortic catheter and pump sales. And while we obviously won’t see constant currency revenue growth rates in 2018 as high as what was achieved in 2017 since we lapse the acquisition of Vascular Solutions, we expect our Interventional North America business to grow double-digits on a constant currency basis during 2018. Turning to Anesthesia North America, fourth quarter revenue was $49.9 million, which was down 9.4% on a constant currency basis versus the prior year period. Excluding the impact of shipping days, Anesthesia constant currency revenue was down approximately 2%. The decline in shipping-day adjusted Anesthesia revenue was due to lower sales volumes of existing products, in part because of the distributor ordering pattern issue I referenced earlier. This was somewhat offset by an increase in revenues generated from the Pyng acquisition, as well as an increase in new product sales. In 2018, we would expect our Anesthesia business to show a modest improvement in constant currency revenue growth as compared to the levels achieved in 2017. Shifting to our Surgical North America business, its revenue decreased 9.8% on a constant currency basis to $43.7 million. Adjusting for shipping-days, Surgical constant currency revenue declined about 2%. The decline in shipping-day adjusted revenue is primarily due to the decision we made to exit a lower-margin product in the third quarter of 2017. As we look forward into 2018, it is our current expectation that our Surgical business continues to report negative constant currency revenue growth in the first half of the year because of the difficult comparison resulting from the elimination of the lower-margin product line. However, comps ease in the second half of 2018, thereby causing full year Surgical constant currency revenue growth in 2018 to be flat to 2017. Included in our thoughts for 2018 Surgical revenue is that we will need to file an additional 510k associated with our Percuvance product line, and that we will be re-introducing the Percuvance product back to the market in the fourth quarter of 2018. We do not expect any material revenue associated with this product in 2018, however, we continue to believe that this product offering will be a growth driver in the future. Surgeons enthusiasm for the product continues to be high and we believe that will continue through the 510k filing period. Moving to our overseas operations, fourth quarter EMEA revenues were down 2% on a constant currency basis to $143.6 million. Normalizing for shipping-days, EMEA constant currency revenue increased approximately 4%. This was the result of revenues generated from acquired businesses and new product sales. As I previously stated, we expect the Vascular Solutions distributor headwinds to turn to a tailwind in 2018, and it is our current thought that EMEA constant currency revenues will show an improvement in 2018 as compared to the constant currency revenue growth rate achieved in 2017. Turning to Asia, our fourth quarter revenue increased 4.5% on a constant currency basis to $78.8 million. The shipping-day phenomena that impacted our North American and European operations did not have a significant impact within Asia. As such, constant currency revenue growth within Asia was primarily due to the benefit received from acquired businesses and price increases. I am pleased to report that China grew 10.4% on a constant currency basis in quarter four, continuing the positive momentum from quarter three. During 2018, we would expect the constant currency revenue growth rate within Asia to be slightly better than the full year 2017 constant currency revenue growth rate. In part, this is because of our decision to go-direct within China. As you may recall, taking our business direct within China caused a headwind to growth during the first half of 2017 as compared to the first half of 2016. This became a tailwind for Teleflex during the second half of 2017 and we expect this to continue in 2018 as well. Next, I’d like to brief you on our OEM segment. During the fourth quarter revenue was relatively flat at $46 million. This was primarily due to the fewer shipping days, and if you were to normalize for that, constant currency revenues would have improved by about 2%. And lastly, fourth quarter revenue for the businesses within our all other category was up 67% on a constant currency basis, totaling $90.7 million. Growth here is primarily attributable to the acquisition of NeoTract, and I would like to now provide you a more detailed update on. Teleflex completed the acquisition of NeoTract on the first day of the fourth quarter, and as such, received an entire quarter’s worth of NeoTract results in 2017. I am pleased to say that the integration of this acquisition remains on schedule, that the legacy management team remains intact, and that we have not experienced any regrettable sales force turnover. In fact, employee engagement remains very high, and we remain committed to investing behind this business to ensure that their hyper-growth revenue trajectory continues in the future. During 2017, NeoTract revenues reached $125.5 million, which is an increase of 149% year-over-year. The 2017 revenue performance was also better than our initial expectations when we announced the acquisition which called for revenue of between $115 to $120 million. As we look forward into 2018, we expect NeoTract revenue will grow at least 40% over 2017, while we continue to think that it will be breakeven at the adjusted earnings per share line in 2018. After 2018, we continue to expect significant revenue and adjusted earnings per share accretion, including adding between $0.35 to $0.40 of adjusted earnings per share in 2019. In order to continue NeoTract’s high growth trajectory in 2018, we have a very focused commercial strategy. The core of that strategy is driving utilization in existing accounts, or as we like to say, going deep. We believe there remains a significant opportunity to drive growth by treating more of the BPH patients each urologist actively manages. This strategy clearly delivered results in 2017, and in 2018 the emphasis on going deep will be even stronger. Next is to methodically begin driving the adoption of UroLift into the early majority segment of the market. We believe UroLift has the clinical data, wide physician recognition and patient demand to begin penetrating this large portion of the overall market. And lastly, with the recent positive coverage decision from United, UroLift has now reached approximately 220 million covered lives in the U.S. Our commercial team is focused on making practices aware of this broad patient access to UroLift, further facilitating adoption of this product. In addition to the items I just discussed regarding how we are going to grow the NeoTract business in 2018, I am pleased to say that we recently received 510k clearance for changes to the IFU for both the first and second generation UroLift devices. This 510k clearance included the removal of the obstructive median lobe contraindication that previously existed on the devices, the addition of a median lobe indication, as well as lowering of the minimum age of men who could get the UroLift procedure to men 45 and older, as compared to the previous IFU which stated that the minimum age was 50 and older. Given that the treatment of patients who have a median lobe can be different than those that do not, we intend to embark upon a methodical sales training process during 2018. As such, we don’t expect to see an increase in 2018 UroLift revenues associated with the receipt of this 510k. However, the removal of the contraindication should be another catalyst for revenue growth in the future. Lastly, before I turn the presentation over to Tom, I’d like to give you an update on another significant market opportunity that we also recently received some good news on. For those of you who may not be familiar with it, RePlas is a lyophilized fresh frozen plasma product which was originally developed by biologic scientists at Vascular Solutions and is now being developed in collaboration with the U.S. Army. When Vascular Solutions was a stand-alone public company, it sized the potential market at approximately $100 million, and we agree with that assessment. Following Teleflex’s acquisition of Vascular Solutions, in May of 2017, we commenced a Phase I clinical study to assess safety and tolerability. Following the completion of the Phase 1 study which is expected to occur around mid-year 2018, we initially anticipated that we would need to do a second clinical trial and that we would not be able to commercialize the product until late 2020. However, in December of 2017, the FDA and DoD launched a joint program to expedite the approval of medical products that are intended to save lives of the U.S. military, including freeze-dried plasma. Members of our Vascular Solutions biologics group had a meeting with the FDA in early January and the FDA confirmed an accelerated BLA approval pathway, and confirmed that an efficacy study is required post-approval. We continue to dialogue with the FDA and it is our current hope that we will be able to launch earlier than our initial expectations which called for a launch date of late 2020. We will continue to inform the investment community as to when we will be able to launch RePlas as we learn more from the FDA, but to date our conversations have been quite positive and we are excited about the opportunity to get this valuable product into the hands of the U.S. military as soon as possible. That takes me to the end of my prepared remarks. Now, I would like to turn the call over to Tom for a review our financial results for the fourth quarter and our initial financial guidance for 2018. Tom?
Thomas Powell:
Thanks, Liam, and good morning everyone. Given the previous discussion of the Company’s revenue performance, I’ll begin at the gross profit line. For the quarter, adjusted gross profit was $336.3 million versus $276.7 million in the prior year quarter. Adjusted gross margin was 56.5%, a 270-basis point increase when compared to the prior year period. The expansion in adjusted gross margin was largely due to an increase in sales of higher margin products and the acquisitions of Vascular Solutions and NeoTract which are accretive to gross margin. Adjusted operating margin improved 40 basis points to 25.4%. The improvement was related to the gross margin flow through, somewhat offset by the addition of NeoTract, which operates at a higher OpEx cost structure. Adjusted net interest expense increased to $23.5 million from $11.7 million in the prior year quarter. The increase reflects the impact of the additional borrowings to finance the acquisitions of Vascular Solutions and NeoTract. Turning to our adjusted tax rate, for the quarter it was 10.9%, which compares to the prior year period rate of 16.5%. On a GAAP basis, the 4th quarter tax rate was 163.6%, reflecting $107.9 million of tax expense recorded in connection with the Tax Cuts and Jobs Act. $107.9 million tax expense reflects both a $46.1 million net tax benefit resulting from the reassessment and revaluation of deferred tax balances and a tax expense of $154.0 million for the one-time toll charge on the deemed repatriation of undistributed foreign earnings. We intend to pay the one-time toll charge over the eight-year period prescribed by the TCJA. I do want to point out that the net $107.9 million charge has been provisionally calculated and will be subject to further confirmation. Moving to the bottom line, fourth quarter adjusted earnings per share increased 14.6% to $2.44. Turning now to select balance sheet and cash flow highlights. During 2017, cash flow from operations totaled $426 million or an increase of 4% over the prior year. The increase was primarily the outcome of improved operating results, partially offset by a tax refund received in 2016 that did not re-occur in 2017. Finally, during the quarter our gross debt balances remained constant and our leverage per our credit facility definition stood at 3.57 times. That completes my comments on the fourth quarter. Now I’ll move to 2018 guidance. Beginning with revenue. For 2018 we expect total constant currency revenue growth of between 12% and 13%. Included in this estimate is an assumption that our organic constant currency revenue growth is between 5% and 5.5%. This represents an improvement from the 3.2% of organic growth that we achieved in 2017, and this acceleration can be attributed to a few items. First, the headwinds we experienced during 2017 associated with our distributor conversions in China and Europe are expected to become tailwinds for 2018. Additionally, during 2018 we have one additional shipping day. And finally, we anticipate that the combination of Vascular Solutions and NeoTract will add approximately 1.5% to our organic growth rates. This reflects 10.5 months of contribution from Vascular Solutions and 3 months from NeoTract. And as a reference point for 2018, if our organic constant currency growth were to be calculated assuming a full 12 months of organic growth, for both NeoTract and Vascular Solutions, then the pro-forma 2018 organic growth rate would be in the range of 7.0% to 7.5%, or 200 basis point higher. Turning next to M&A, we project previously completed acquisitions to contribute between 7% and 7.5% of revenue growth in 2018. This is largely comprised of Vascular Solutions and NeoTract, with a very modest amount coming from Pyng and Airway Medix. Lastly, our assumption is that FX will create a 2% tailwind, and as a result, we expect as-reported revenue to increase by 14% to 15%. Based on our currency assumptions, this translates to an as-reported revenue range of $2.447 billion to $2.468 billion. A stronger Euro relative to the USD is the primary driver of the projected 2% foreign exchange tailwind projected in 2018. For 2018 planning purposes, we had assumed a Euro/USD exchange rate of $1.18 which approximated the spot rate at the time we established our 2018 financial plan. Turning next to gross margin. During 2018, we anticipate that adjusted gross margin will increase by 170 to 220 basis points to a range of 57.5% to 58%. Of the expected 170 to 220 basis point increase, approximately 125 to 150 basis points is attributed to NeoTract and Vascular Solutions and the remainder attributed to operations cost improvement programs and benefits from our previously announced restructuring programs, net of inflation. Moving to adjusted operating margin. We anticipate that our adjusted operating margin will increase by approximately 100 to 140 basis points to a range of between 26.1% and 26.5% in 2018. Gains from gross margin will be the principal driver of the increase, which will be muted somewhat by the addition of NeoTract which carries a higher OpEx cost structure. That takes me to our preliminary adjusted earnings per share outlook for 2018. This slide serves as a bridge from our full year 2017 adjusted EPS, to our full year 2018 adjusted EPS outlook. Beginning with 2017 Adjusted EPS of $8.40, from an operating standpoint, in 2018, we project our business will add approximately $1.61 to $1.71 per share, or growth of approximately 19% to 20%. This will be primarily driven by positive revenue and mix, the continued reduction of manufacturing costs, as well as the positive contribution from acquisitions. Turning to FX. Based on our current estimates, we expect foreign exchange will create an adjusted earnings per share tailwind of approximately $0.26. Moving to taxes, during 2018 we project that our adjusted tax rate will be between 15% and 16%. That would mean that taxes could range from a headwind of approximately $0.07 to a tailwind of approximately $0.03. Our estimate is that adjusted weighted average shares will increase by approximately 500,000 shares to 46.9 million for full year 2018 which is dilutive by $0.10 per share. And finally, we expect interest expense to be approximately $109 million and a headwind of approximately $0.55 per share in 2018. Our interest expense assumptions for 2018 reflect no changes to our current capital structure. However, we are forecasting additional rate hikes during 2018 that will impact our revolver and term loan, which are floating rate instruments. In total, our outlook for 2018 adjusted earnings per share is $9.55 to $9.75, representing growth of between 13.7% and 16.1% versus 2017. Given the recently enacted Tax Cuts and Jobs Act I’d like to provide a little more color surrounding our current expectation for how the TCJA will impact our adjusted tax rate going forward. As the initial House and Senate drafts of tax reform began circulating in late 2017, our initial assessment was that tax reform would negatively impact our future adjusted tax rate. However, once the regs for TCJA were published, our initial assessment was that the impact would likely be neutral for our tax rate going forward. However now that we have had more time to assess the specifics, we now expects tax reform to provide a modest benefit to our 2018 adjusted tax rate. Combining the benefit of a modestly reduced tax rate with improved access to offshore cash is a positive outcome for Teleflex, and certainly a better outcome than was envisioned just a couple of months ago. And while it is not our practice to provide specific quarterly guidance, I did want to highlight some considerations regarding variability between our 2018 quarterly expectations. During 2018, we expect that the percentage of revenue generated each quarter will mirror the quarterly percentages achieved in 2017 when we achieved approximately 23% of our full year revenue during first quarter, approximately 25% in both the second and third quarter, with the remainder in fourth quarter. For the first quarter, we have one fewer shipping day in 2018 versus 2017. We will then get the benefit of one additional shipping day in each of quarters two and four, while there is no change in the number of shipping days during third quarter. Overall, we will have one additional shipping day in 2018 as compared to 2017. From an adjusted earnings perspective, we also expect that the cadence of our quarterly earnings will closely resemble the percentages attained in 2017, with about 45% of our full year 2018 earnings generated during the first half of the year and about 55% generated in the second half. And specifically for the first quarter of 2018, adjusted EPS growth is projected in the mid to high single digits. I would like to close by saying that during 2017 Teleflex delivered numerous positive outcomes. We completed the acquisitions of NeoTract and Vidacare which will serve to accelerate our future revenue growth and margin expansion profile. The China and Vascular Solutions distributor conversions are largely complete placing the revenue headwinds behind us and positioning us for growth in 2018. Also in 2017, we raised adjusted earnings per share guidance following each of the first, second and third quarters. And we achieved the upper end of our most recently provided adjusted EPS guidance range. As we look toward 2018, we are guiding to constant currency revenue growth of 12% to 13% and organic growth of 5% to 5.5%. Gross margin is expected to expand by an additional 170 to 220 basis points as an outcome of the recent acquisitions and ongoing operations productivity initiatives. On the bottom line we expect another year with adjusted EPS growth in the mid-teens. And as a final thought, we have scheduled an analyst day for May 11th in New York City when we will share with you a longer term financial outlook and will provide strategic updates on key businesses and product offerings. That concludes my prepared remarks. At this time, I would like to turn the call back to Liam for some closing comments.
Liam Kelly:
Thank you, Tom. In closing, while we had some transitory issues that impacted our fourth quarter results, we feel very good about our full year 2017 performance and remain confident about what Teleflex can accomplish in 2018. Let me briefly recap some of the drivers in 2018 as we see them. First, our two scale acquisitions are transforming our organic growth profile. NeoTract is poised to continue driving adoption of UroLift and delivering rapid revenue growth. And Vascular Solutions is poised to accelerate momentum in the business with tailwinds from our go-directs in Europe. Next, we see double digit growth in our Interventional North America segment and accelerated growth over 2017 growth rates in both our Asia and EMEA segments. And lastly, new products are expected to continue building leadership positions in key niche markets and taking share in others. Overall, we believe we are in a great position to deliver a meaningful improvement to our organic constant currency revenue growth rate, demonstrated by our guidance of 5% to 5.5% for the full year. When you combine that with our adjusted EPS guidance of approximately 15% at the midpoint, we believe that makes for a very compelling 2018. That completes my remarks. I would now like to turn the call over to the operator to begin the Q&A session.
Operator:
[Operator Instructions] Thank you, and our first question comes from the line of David Lewis with Morgan Stanley. Your line is open.
David Lewis:
Liam, I want to start on organic growth for a second and the Company had a lot of successes, but organic growth progression has not been one of them. So, as new CEO two part question. What can you do to break this cycle? And as I think about 2018 expectations, our sense is 5% to 5.5% underlying maybe that's 3.5% to 4% in the core, one point from BSI, maybe 0.5 point from NeoTract, but why should investors believe those are appropriately risk adjusted here to start to year? And then I've a quick follow-up for Tom.
Liam Kelly:
Let me start with first part of your question. How do we address this? I think David what happened in the fourth quarter, we see it as predominantly transitory, really our full year guidance calls for a total constant-currency growth of 14.25, 14.75. Within our full year performance for sure, there're puts and takes, NeoTract performed better than expectation as did our smaller M&A and new products continue to show progress, BSI and the core business underperformed modestly, due to two -- and I again say they're transitory events, in all in all our final results were 14.1% constant-currency growth, which was approximately 7.5 million of the shortfall in the middle of our guidance range. In this entirety Dave, we're talking about 30 to 40 basis points on a full year basis and really the drivers of the shortfall are continued destocking by the BSI distributors and also despite a really strong flu season, we see distributors in the United States file less inventory. Both of these, as I said are one-time transitory in nature, and we have seen in the past when U.S. distributors destock, they normally normalize their stocking levels in subsequent quarters. So it's a factor of having 50% of your North American business going through distributor. Now to address your question on the full year and bridging to 2018, the components of our organic constant-currency growth are as follows. We're guiding to 12% to 13%, so if we remove M&A of 7% to 7.5%, on organic, true organic growth of 5% to 5.5%. Vascular Solutions and NeoTract contribute 4.5% to that organic growth resulting in an organic growth of 3.5% to 4% from our core business. Now our growth in 2017 Dave was 3.2%, we have an additional billing day in 2018, which should add 40 basis points, and that gets me to the lower end of my range. Headwinds and tailwind combined like Surgical as the China go-direct and positive pricing from our go-direct really make me feel very comfortable with the guidance range and our ability to achieve it. I would also like to point out that the one-time impacted quarter or revenue have not hold our thinking on 2018 revenue and I really remain very positive on that and a real highlight for me I think was the over performance of NeoTract and I've often said this, that none all of rules is equal. And I continue with that hypothesis the growth that we delivered and areas of our performance, where our higher margin categories such as NeoTrack, our Vascular business unit invest in North America with Vidacare including intra-aortic delivering again over $20 million. So, I think that the future for 2018 looks relatively bright when you feel back the other elements of our organic growth, I would feel it's quite deliverable.
David Lewis:
Okay, Liam, thank you, that's very clear. And then, Tom, just thinking about 2018, the real surprise obviously is tax, and there's all the maturation these last two months. So, if I think about the tasks, a couple of questions. One, I feel like on the margin with the tax guidance, the 2018 earnings guidance seems conservative. So could you talk about, the level of reinvestment of some of these tax savings given how late in the year they occurred? And then this rate you've talked about, for 2018, is that the rate we can think about for this business for the foreseeable future?
Thomas Powell:
Okay, so David, as you point out, we do see a tax reform being a nice benefit for us versus NeoTrat expectations as we think about 2018 as Teleflex has become a more complex organization as a result of our recent acquisitions and growth, you know, there are some investment areas that we want to put some money towards to continue to build out our capabilities. We think the numbers of these are investments that will serve us well into the future. So we are reinvesting some of that tax savings. As far as the rate going forward, we've got a couple of things going on. First of all, as more and more of our income is generated from some of the recent acquisitions that could put some unfavorable mix in our tax rate as a result of having more US based income. Now with that being said, we're in early stages of assessing the recent tax reform regulations and it's, our expectation that we'll continue to work through those regulations in the coming months, to try and identify additional areas for planning. So as we think about the rate, I think it's a good baseline to start with, with the expectation that, that mix will be unfavorable in the coming years given more income in the US, but you know, we'll, we'll look to find opportunities to offset that with the future tax planning ideas.
Operator:
Thank you. And our next question comes from the line of Larry Keusch with Raymond James. Your line is open.
Larry Keusch:
Liam, I just wanted to circle back on, on the distributor side. I think, the one thing that's going to be bothersome them to, to folks today is obviously the 90 basis point decline in the core volume. So, again, as you, as you look at your businesses that were impacted by the distributor ordering patterns. I guess the question is why do you really think that occurred? And do you have any insight as we see here on February 22nd as to kind of what those distributors are now doing?
Liam Kelly:
Thanks Larry. So, why it occurred given that we had such a strong flu season. It just the timing of as when these distributors would stock up for that flu season. Encouraging thing for me Larry is that we do have a very strong flu season. It's predominantly impacted in our Anesthesia and Respiratory businesses in the fourth quarter. And our expectation is that as it did previously it will come back in 2018. We do see positivity in the first month of 2018 early in the quarter. So I'm poised by that quite frankly, Larry. And the other thing that we did look at in quarter four was to fix our end customer volumes to ensure that there was no -- lots of share in any of these segments. So what we found was there our end customer volumes with trades being demonstrated a solid 5% end customer demand. So in my mind Larry, it almost an elderly has to normalize through the early part of 2018.
Larry Keusch:
Okay, very good thank you for that. And then just two other questions. So on NeoTract, I guess they have when do you expect to launch the second generation device? And really why do not anticipate any real revenue generation from removal of the median lobe communication? And then the other question is on RePlas. I understand that you meet with the FDA now in January and they said that you're trial can come post approval. So what happens as you understand today, what's the sort of pathway to getting this on the market and would it only be available for military use until you complete that other trial? Thank you.
Liam Kelly:
Okay, so I will start with RePlas, Larry. So, we did meet with the FDA in early January, they meaning was very positive I would say first of all, secondly we're still wining for absolute, as to what the recruitment is to get approval and what that approval would mean. So our anticipation is that the first clinical study would be provisioned with additional bench testing to get approval and that should accelerate having RePlas in the markets from late 2020 to area of that. We’re still waiting more clarity from the FDA that will mean jus military approval or general approval. Personally, Larry, I think it's only likely that they would go for a specific approval for military because it would be hard to a put a wall around this and to stop linkage of the product into other areas in view, but I still for the FDAs going back. We will have the update on this and we should have more clarity by the time we get to our investors day in March. Your second question was around the median lobe and around the median lobe. I think that clinicians as the use the euro products can make their own determination as to whether this is used for a median lobe. Obviously, we cannot promote this for that application. And secondly there is a significant amount of training that we need to do in order to prepare our sales force to be prepared to promote this product for the median lobe. That’s going to take a number of quarters and that’s why we expect, the revenue pick up from this to be a little bit later. In my mind, Larry, one thing that it does remove is an advantaged system of our competitors kind of that they can talk to the physicians and say, our buyers is applicable to median lobe and lateral lobes. So I think that will help our sales force out there in the market place. Your last -- I am taking in reverse order, Larry, I apologize. Your first but I'm addressing last is the launch of UroLift 2. And we're still in pre-market study with that Larry and we will update as soon as we have that completed. And we may once consider given that we've got the train -- sales force in the median lobe, just deleting that a little bit, but will assess that as we go through. We don’t want to overburden this sales force. I want to have them selling this product because it's such a rapidly growing product and we have as we said, plus 40% growth planned in -- at least 40% growth planned for 2018 for NeoTract.
Operator:
Thank you. And our next question comes from the line of Richard Newitter with Leerink Partners. Your line is open.
Richard Newitter:
Liam, just going back to the timing of the kind of the U.S. distributor orders that you said, your confidence is coming back. In a follow-up, you said that the flu and the impact of having on the ordering that was one of the kind of the main reasons that gives you confidence, it's going to come back early in the 2018. I guess compared to the situation that you've experienced when this has occurred in the past, was it also the flu or was it something else? And I'm just trying to make sure I understand what's path for Urologic. Thanks.
Liam Kelly:
Yes, they are linked but not absolutely. So a strong flu facilitates the burn off of the inventory that they preorder. What happens in quarter four, Rich was we anticipated the normal buying that happens for the flu. We experienced it in our Vascular business, but in our Respiratory and Anesthesia business, it didn’t happened. The flu is very strong so that is why I'm pretty confident that buying will happen in 2018, and we firmed off because the flu season is actually at a its more prevalent than last year it's a strong flu than last year, and therefore I would anticipate that we would see this recovery in 2018 as distributors restock the in customer demand as I've said that we've seen in quarter four with substance being at that and the early signs in January would also defend to yourself.
Richard Newitter:
Okay, and just to be clear though you think that will come back in the early part of the year like I said this is first half phenomena and or is this it's something that kind of that get spread out through '18. I'm just trying to make sure we get our models right here as we think of the quarter?
Liam Kelly:
So, you would anticipate seeing the recovery in the first half and what we'll be watching closely as the normal a destocking in quarter three. So the normally destocking quarter three for inventory department through, so it may have as it may take it's through three quarters to materialize Richard.
Richard Newitter:
Just another one on Percuvance, I think you made some comments. What if anything is contemplated in 2018 guidance and can you highlight some of the vascular new product releases that is that you are looking forward to.
Liam Kelly:
Okay, so again I'll start with Percuvance, as I said in my remarks Rich, we anticipate -- we will be these back in the Americas following in the 510k in quarter four so therefore as we don’t have a revenue plans in 2018. We were looking forward to getting back in the markets, resurgent, enthusiasm is still very-very strong, for the products. And we're running the Vascular new products, we're still very encouraged by our new PICC portfolio with our positioning system. Our Medline catheter that has obviously got our folding technology on it to help prevent infection and those and our endurance products, so we have a good bowl of the new products coming through our vascular business that has been to buoy the solid revenues that we've seen within vascular in quarter four and that we anticipate in 2018, and beyond and vascular is one of our stronger margin business units, so having solid growth there, back to my hypothesis not all growth is equal, I think will be very encouraging for us.
Richard Newitter:
And one just last one, UroLift, I appreciate that you're not committing to when precisely that UroLift is due -- is going to come out. What is key feature that you're going to think this is going to add? And then anything we should be thinking about on the gross margin side, when it does launch?
Liam Kelly:
So, I've starting and then gross margin and then I'll go back to the features Rich. So the gross margin we anticipate -- the current gross margin in the low 70s. We think that once we have fully cannibalized that this has potential to move it into the high 70. Then regarding the features, I feel the features are really around ease of use. So, the new product is ease of use, there's also less waste. And when you consider that the amount of the procedures that are done in the doctors' offices, and DACs with the doctors' offices are on roughly around 60%, having a large volume of waste, is a problem for them, and this will make it a lot of easier for them. For Teleflex, it will help us comply with some of our green initiatives, but also for the customer it will mean less waste in the procedure and less products we held on the shelf, and the product that is actually easier for them to use and it should help them in positioning the system easier when they're delivering the implant.
Operator:
Thank you. And our next question comes from the line of Matt Taylor with Barclays. Your line is open.
Matt Taylor:
So want to follow-up on some of the components of organic growth you've been talking about here. If we look at the five to 5.5 and consider that you're getting 1.5 from Vascular in NeoTract. Can you talk about the shift from headwind to tailwind of distributor conversions? How much that adds? And then in terms of the come back on easy comps with the distributors in the U.S. how much does that add, and we kind of have base with 3.5 to four?
Liam Kelly:
So, as I said earlier when I was talking about our guidance, our total mix versus the mid range of our guidance was approximately 2.5 million, less than half of that came from the North American distributors, more than half came from the EMEA destocking, so that would probably help you. As I look to choosing guidance, and the headwinds and the tailwinds, the tailwinds we had said that the headwinds for the China go direct was approximately 20 basis points in the year 2017, so that we would expect that to come back in 2018. The exit of the surgical business is approximately $8 million to $9 million in the first half of the year, so that's why you see Surgical come back quite stronger in the second half of the year. And then the distributor go-direct, which would be seen in pricing and that would have a better return for than the Surgical destocking and from the best way from the appointment. So you can see why I'm fairly comfortable with the guidance range that I've put out there today.
Matt Taylor:
And I want to follow up on Percuvance, you made some comments there, but generally before you would talk about that is the biggest organic opportunity for the Company. Is that still your view given some of the delays that we've had here? Or do you think that the ultimate contribution could de=lever?
Liam Kelly:
So first of all, I clearly made those comments before we acquired NeoTract, regarding the biggest organic growth opportunities. We still see the macro potential for that in the $300 million and the lot of pent up demand for the product, a lot of enthusiasm for surgeons and we look forward to getting back into the marketplace and what we do get back, we'll reassess the growth trajectory for it. Quite frankly, I think that we were still early in the adoption call for surgeon. I don't see this having a longer term impact on Percuvance and are percutaneous offering in the longer term. The important thing for me is to get back with a very solid product that works and then do the market a little bit like what we did, -- what we're doing with NeoTract today. I'm going to say that the strongest growth opportunities for Teleflex in the next number of years is really NeoTract give them that the growth profile about that asset and given them the fact that it closed much stronger than we expected in quarter four and even with that strong close, obviously that has the jump off point. We haven't changed our, our hypothesis that it should grow by 40% in 2018. So therefore I think in 2018, 2019 and 2020 and beyond, that will be one of the fastest growing organic acids in the Teleflex portfolio for a number of years to come. And based that on the fact that just exclusively when the United States, we've done $125.5 million in 2017 in the addressable market of about $6 billion. We've only begun to penetrate the urologists, we're at the very early stages of that and we've just now got 220 million lives covered. We're almost at the stage where we have full coverage across the United States.
Operator:
Thank you. And our next question comes from the line of Matthew O'Brien with Piper Jaffray. Your line is open.
Matthew O'Brien:
Liam, not to push too hard here, but the two year stack growth of NeoTract actually accelerate in Q4. So. clearly there's a lot of momentum here. Love to hear exactly what drove some of that acceleration you saw in Q4, again on a two year stack. So adjusting for the seasonality already. But then, the 40% outlook for the business, it's a pretty meaningful deceleration given what you're doing, I get bigger numbers. So why would it just be 40 against, given how much momentum that we're seeing?
Liam Kelly:
Yes, we see we see that momentum as well and we're very encouraging by it Matt. The way we look at this is, we have now trained and converted many of the area the doctors, for this technology. We are now moving into the early majority. We believe, perhaps we're being conservative in our view, but we believe that going deep rather than going wide, and we moved to this area majority meaning potentially take a little bit longer to convert that part of the market, but it’s the most bigger segment of the market and once we do begin to convert it. We see the potential that we accelerate that within the future. So that the view that we have today, that’s the view of the new attractive management team and it's consistent with what they would have pursued themselves the price company before the acquisition, and that has a reason we left that stand along business unit to bring that expertise to bear. And we believe that perhaps it may be somewhat conservative given what we see in the growth rate but right now, we start to see trajectory on that really majority we think that’s an appropriate guidance of at least 40% for 2018.
Matthew O'Brien:
It's the follow up question. Just on the gross margin range, it's kind of a broad range 170 to 220 basis points of improvement. So, can you just give us a sense for what gets you to the low end of that range versus what get's you to the high end of that range?
Liam Kelly:
I'm going to actually ask Thomas to cover that.
Thomas Powell:
So, with any given year makes certainly the factor and in this area we got a pretty high growth profile going on with NeoTract. I'd say that pushes the upper end of the range and you’re looking for stronger growth in some of the higher margin products about frame level. I wouldn’t say that necessarily there is anything that we envision right now that’s going to cause us to not the headed right towards the middle of that range. So nothing extraordinary that would need to occur this to get there. And again you get the upper end of the range its more growth in the higher mix products, on margin products excuse me.
Operator:
Thank you. Our next question comes from the line of Anthony Petrone with Jefferies. Your line is open.
Anthony Petrone:
Maybe a couple of questions just on a quarter again distributor as it relates to flu and then few on NeoTract. Just on looking ahead to second quarter, third quarter when you do actually get a restocking from distributors, just given that extent of food this year, you think that restocking event will be up year-over-year. And then on NeoTract, I know the strategy here is to go deeper. Can you us a sense of average utilization today of urologist that are users UroList usres maybe on a monthly basis and no where potentially that can go over time. Thanks.
Liam Kelly:
I will start with the distributors and what we would anticipate is to see in the first half given the strong blue, some think of within our Anesthesia and potentially Vascular and respiratory businesses. The really, the cutting point for it will be quarter three where there is normally a destocking. If it burns off the inventory which would be flu season that we’re having, I would anticipate that, that would occur. We would anticipate being a smaller destocking in quarter three. And then again, you're right back into the flu season for the restocking and order forth, so would be depended on what the blue looks like in quarter four. Regarding the customer, the NeoTract question, pardon me. What we see is that coming from existing customers in 2017, 63% of the revenue growth it came from existing customers in 2017 and in order to support this business we have continued to invest within the sales channels. And I know as we were anticipating in having a food sales organization of consultants and associates of approximately 70, we actually went above that in at the end of the year for that group of people. So that we will see so we continue to invest behind it to drawing and accelerate that top line growth, but then to your specific question 63% of the growth was coming from existing customers who in 2017.
Operator:
Our next question comes from the line of Kristen Stewart with Deutsche Bank.
Kristen Stewart:
I was wondering if you can give us, what exactly you are expecting from NeoTract in terms of the sales because I'm a bit surprise that given the strong momentum that you are seeing. In the fourth quarter, why you are not seeing any level of accretion on the bottom line? I would have expected maybe a little bit more like maybe $0.05 to $0.10 or $0.10 to $0.15 just given the higher numbers I guess you are seeing in fourth quarter and it would have struck me as a little bit higher than you would have expected at the time in the acquisition as well. Why isn’t NeoTract at least modestly attractive for 2018? Is it just reinvestments that you are doing?
Liam Kelly:
So, I would start and then I'll pass it over Tom who can give you much more detail on the components of the NeoTract. But in essence, the OpEx is much higher in this business to drive the revenue growth. The leverage for NeoTract really start to kick in 2019 and beyond, and as we have said in the past that we expect $0.35 to $0.40 of ESP accretion in 2019. And Kristen, that's a function of the continued top line growth and then you try to get leverage within the P&L based on the top line growth and the percent of OpEx required to run this business, as a percent of decreases that's why you try to get the leverage. So, the growth that we expect on the top line at least 40%, if we took at 40% we'd be approximately $50 million of growth, but we are investing behind this asset. We are doing registrations in Japan. We're gaining more clinical data. We are recruiting educators were trending on the median lobe, we're adding to the sales force in order to continue the hyper growth that we've seen. And I'll ask Tom to add any other color that he would like.
Thomas Powell:
Well, Kristen, as we think about it, initially our expectation was growth of approximately 40% for 2018 and now based on the strength, so I think it's at least 40%. For the extent that we do see those revenues growing at a higher level and initially expecting, we should expect to see a little bit of the EPS accretion coming through. But right now again we're not modeling that higher level of growth, so our guidance is based on that 40% level.
Kristen Stewart:
And I guess just with all of the potential growth opportunities is it your view that if NeoTract continues to be better than expected, would be likely to reinvested in all of these opportunities or would you like that flow to the bottom line? How should we think about that?
Liam Kelly:
So we've already actually even in quarter four accelerated investments within the sales organization to drive to top line growth. We're still early in the adoption curve. We would obviously at the time making assessment, but I am inclined to continue to invest in a productive state of channel driving a low 70s gross margin products. But we'd be thoughtful on that and take a balanced approach to delivering shareholder return and securing the long-term growth of the NeoTract portfolio.
Operator:
Thank you. And our next question comes from the line of Dave Turkaly with JMP Securities. Your line is open.
Dave Turkaly:
I just wanted to talk Percuvance just quickly again. Is this the same issue like the -- I know you said 510k you expect it 4Q '18 but did something additional happen in the quarter, any product reworking or is this still the same initial thing that happened late last year?
Liam Kelly:
Nothing, new David, this is ongoing. When I spoke in quarter three, I was not anticipating having to re-file the 510k, and that directly what's changed our thinking is the fact that we have to re-file our 510k, which means putting together significant dossiers and doing a filing to the FDA.
Dave Turkaly:
And then on NeoTract, I wondered if you could just give us an update on sort of the sales force size there, and maybe if there's sort of a plan in terms of how many you plan to -- how many new folks you plan to hire and sort of what you think they can do from a productivity standpoint when they're fully ramped?
Liam Kelly:
So, I'll go back to the history in 2016 there were approximately 50 sales reps, at the end of the year between neurology consultants and associates, we actually thought we'd end up with 70, we went modestly over 70, we continue to see that cadence of as in reps and associates in 2018 to drive the growth.
Operator:
Thank you. And our next question comes from the line of Matthew Mishan with KeyBanc. Your line is open.
Matthew Mishan:
First off just on Vascular Solutions. If you have the numbers the year-over-year, what was the growth in Vascular Solutions for the quarter and for 2017? And then why would there be a -- why would a shortfall from distributed conversions be a surprise to you, I mean you've kind of done this before?
Liam Kelly:
We have done it before and when we have done it before, Matt, we've been dealing with Teleflex contracts. In this instance, we were dealing with Vascular contracts, which added some additional complexity unfortunately and calls a bigger impact then we were expecting. Turning to the VSI growth and almost all of the headwinds in VSI had been in the EMEA because of these go direct, so I am going to give you a number without the EMEA with the global growth on a full year basis Matt which is probably a better indicator then doing that, and that is 10%. And the other comment I would make is that the Interventional North American business that we have merged with VSI also grew about 12% organically in 2017. And that is being sold by the same sales organization to sell VSI. So that’s why we are reasonably confident on the double-digit growth, we've got the go-direct in 2018, we've got the go-direct become a tailwind, we got a motivated sales force, our excluding EMEA, the overall business is growing in that double-digit range. And once we have the EMEA, transitory issues behind us, we think that we are setup for success in 2018 and beyond.
Unidentified Analyst:
Okay, great that’s helpful. And just two more, first on the freeze-dried plasma, with the accelerated approval pathway, how quickly can you manufacturing of RePlas? And last on the tax rate, what have you accounted for with stock options starting to shift?
Liam Kelly:
Okay, with freeze-dried, we have enough capacity, we believe to supply the military demand all with the next four five years. So, as we bring on commercial demand and this is dependent on the FDA clearance, we should have enough capacity to carry through 2.5 to 3 years in the ballpark. We are moving constantly has said that, as we roll the product out, but I think we have enough capacity Matt, and it's not something we are concerned about, in the near to near to medium term. And on the tax rate, I let Tom, sorry Tom.
Thomas Powell:
And then with regards to the windfall in the tax rate, so certainly last year, annuity in terms of the change in the accounting, so we monitored how that went throughout the year and we pushing it in our plan for this year, we included in the estimated, both for the restricted shares that are vesting or the restriction lapsing, as well as an estimate for stock options and that’s based on historical exercise as well as just looking at the number of options out there and available. So, in 2018 the level is slightly elevated from what we saw in 2017 and that’s been included into our tax rate.
Operator:
Thank you, [Operator instructions]. And our next question comes from the line of Mike Matson with Needham and Company. Your line is open.
Mike Matson:
Tom, I think you said you expect mid to high single-digit EPS growth in the first quarter, did I hear that correctly and buyback lower that kind of the guidance for the full year, if I did hear it correctly?
Thomas Powell:
Well first of all, you did hear it correctly and I think that with given any quarter, there is variability and that’s why we managed to a full year number. Now as we specifically look at the first quarter, couple of things going on, first of all, there is one pure shipping day in the quarter and then as you start to look at the seasonalization of both near track and after solutions operating profit, you start to see some good acceleration sequentially, quarter in quarter out, so we are seeing as more and more growth as the year progresses, so obviously Q1, having a least. Additionally, when you look at the interest expense headwinds for the year, there is a $0.55 headwind and if you look by quarter, the greatest headwind is in the first quarter, about $0.27, so that $0.55 just given how we put debt in the last year to finance the acquisitions, we have got more of a headwinds until we start to anniversary those debt issuances. Now I will say that the first quarter it's been benefited by having a full quarter faster solutions where last year it had have. So those are some of the big moving pieces, in addition last year was a pretty busy year and as a result were distracted from a number of projects, they are studying out the year with a lot of enthusiasm and getting a lot of projects up and running. So those were be the key factors that I would point too.
Mike Matson:
Okay thanks and just one more on with regards to RePlas, a senior member with Vascular Solutions said, it was somewhat expected to be somewhat dilutive to the gross margin, but there wasn't really expected a lot of sales and marketing expense or the drop there or the incremental operating margin on that. The sales were expected to be pretty high. I think your gross margin for lower than vascular solution was in standalone, but just curious. Is that still the case that incremental OpEx on this particular product is pretty low and there is the drop there of if the sales would be pretty high?
Liam Kelly:
So, Mike, it's Liam here. Normally, we would expect a lower OpEx on any sales that you sell in respecting to a military call points just because of their structure. And we already had a channel in the EMS sector because our Vidacare portfolio. So that should also help. We haven't finalized pricing for the product yet, so it's really hard for me to comment and gross margins. We're very focused on getting the accelerated pathway and the approval and then we will -- once we have that we will enter into negotiations on what the price points of this product will get.
Operator:
Thank you. And I'm showing no further questions at this time. I'd now like to turn the call back over to Mr. Jake Elguicze for any closing remarks.
Jake Elguicze:
Thanks, operator, and thanks to everyone for joining us on the call today. This concludes the Teleflex Incorporated fourth quarter 2017 earnings conference call. Have a nice day.
Operator:
Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program and you may all disconnect. Everyone, have a great day.
Executives:
Jake Elguicze - Teleflex, Inc. Benson F. Smith - Teleflex, Inc. Liam J. Kelly - Teleflex, Inc. Thomas E. Powell - Teleflex, Inc.
Analysts:
Lawrence Keusch - Raymond James & Associates, Inc. David Ryan Lewis - Morgan Stanley & Co. LLC Richard Newitter - Leerink Partners LLC Anthony Petrone - Jefferies LLC Mike Matson - Needham & Co. LLC Matthew Mishan - KeyBanc Capital Markets, Inc. Andrew Brackmann - William Blair & Co. LLC Matthew Taylor - Barclays Capital, Inc. David L. Turkaly - JMP Securities LLC
Operator:
Good day, ladies and gentlemen, and welcome to the Teleflex Incorporated Third Quarter 017 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. As a reminder, this call is being recorded. I would now like to turn the conference over to Jake Elguicze, Treasurer and Vice President of Investor Relations. You may begin.
Jake Elguicze - Teleflex, Inc.:
Good morning, everyone, and welcome to the Teleflex Incorporated third quarter 2017 earnings conference call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing 855-859-2056 or for international calls, 404-537-3406, passcode 3479079. Participating on today's call are Benson Smith, Chairman and Chief Executive Officer; Liam Kelly, President and Chief Operating Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Benson, Liam and Tom will provide prepared remarks and then we'll open up the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today, as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. With that, I'd like to now turn the call over to Benson.
Benson F. Smith - Teleflex, Inc.:
Thank you, Jake, and good morning, everyone. I'm very pleased to say that Teleflex had an excellent third quarter as we grew revenue 17.4% on an as reported basis and 15.4% on a constant currency basis. I'm also happy to report that organically we grew our constant currency revenue of 5%. This was a significant acceleration from levels we achieved for the first six months of the year, thanks in part to progress made in our distributor to direct conversion in China. In addition to strong broad based revenue growth during Q3, we also delivered significant margin expansion, reaching an adjusted operating margin of 26.3%, which is the highest level ever attained since becoming a pure-play medical device company. Mind you, this was a tremendous result, as it is assigned that our organic margin improvement initiatives, integration of various acquisitions and our previously announced restructuring programs remain on track. In fact, as you'll hear from Liam momentarily, we're increasing the savings estimate associated with our various restructuring plans. The margin performance in the quarter flowed through to the bottom line and translated into GAAP earnings per share of $1.70, which was up 21.4% versus the prior year period and adjusted earnings per share of $2.12, which was an increase of 17.8%. Finally, on the first day of the fourth quarter, we completed the acquisition of NeoTract, which will help the revenue growth and earnings profile of Teleflex for many years to come. The addition of NeoTract as well as the performance of our base business allows us to once again increase many of our full-year 2017 financial guidance metrics, including our constant currency revenue growth expectations, which we were raising from a range of between 12.5% and 14% to a new range of between 14.25% and 14.75%. Our adjusted earnings per share expectations, which are increasing from a range of between $8.20 and $8.35 to a new rage of between $8.30 and $8.40. This marks the third time this year we have been able to increase our adjusted earnings per share expectations. In closing, we're up to a good start in 2017, and we are positioned well for success in 2018. We continue to see stability within our end markets, good global utilization of many of our products, and positive momentum in revenue generated from the newly introduced products to the market. We've also made significant progress in our distributor conversion efforts, the integration of Vascular Solutions, and have driven substantial margin expansion and shareholder value. As my time as CEO of Teleflex nears a close, I am more confident than ever in Teleflex's ability to succeed in the healthcare marketplace in the future. I completed my prepared remarks. Now, I'd like to turn the call over to Liam.
Liam J. Kelly - Teleflex, Inc.:
Thank you, Benson. And good morning, everyone. For the consolidated company, third quarter 2017 constant currency revenue grew 15.4%. This consisted of Vascular Solutions, which contributed 9.5%; other M&A, which contributed 0.9%, and organic revenue growth of 5%. Beginning with the components of organic revenue growth, during quarter three, we saw volumes expand year-over-year by approximately 2.4%. These volume gains were predominately due to improvements within our Asia segment, as we continue to take steps forward to our China go-direct. In addition to volume improvements in Asia, we also saw a nice uptick in core product volumes within our vascular North American business, our OEM business and from EMEA. These volume improvements were somewhat offset by a decline in surgical volumes, resulting from a decision to exit certain lower margin product lines. While this decision results in a small negative near-term revenue impact, we felt that it was the appropriate thing to do to improve the longer-term margin profile of the surgical segment. As a management team, we will continue to review our portfolio to identify future opportunities to rationalize lower growth margin dilutive segments of our business and we will keep the investment community updated on potential future product line exits. I'm also pleased to report that no Teleflex employee was injured during the recent hurricanes in quarter three. The revenue line for Teleflex was minimal in the quarter, and while we do not have factories or distribution centers in the affected areas, we are currently assessing the impact that the hurricanes may have had on vendors whose materials we use. Our thoughts continue to be with the people still being impacted by the aftermath of the hurricane. Moving to new products. The positive revenue contribution trend we have seen for the past several quarters once again continued, this time contributing approximately 2.1% of constant currency growth. We are pleased with these results as this marks the first time in the company that we have achieved 2% or more in terms of revenue growth, coming from new product introductions, and it is a testament to our internal private development efforts. Unlike previous quarters, new product revenue growth was once again led by our OEM cardiac and vascular products, as well as the regions of EMEA and Asia. OEM new product revenue was primarily attributed to new future products, by cardiac and vascular new product revenue growth, stems from our recently introduced AC3 Intra-Aortic Balloon Pump and our preloaded antimicrobial and anti-thrombogenic VPS PICCs, respectively. Turning to pricing. During quarter three, we saw continued improvement in the average selling prices of our products, which drove revenue higher by another 50 basis points. This is consistent with the levels that we achieved during the first-half of the year, and it was predominantly due to our continued ability to take price on a variety of products within the North American market. Finally, moving to revenue growth, coming from M&A. During the quarter, M&A, other than Vascular Solutions, contributed approximately 90 basis points of constant-currency revenue growth. The contributors here were Cartika and Pyng, with a larger portion coming from Pyng, as Cartika has now moved into organic growth as of September this year. Finally, Vascular Solutions contributed 9.5% towards Teleflex's third quarter constant currency revenue growth. And when compared to the third quarter of 2016, Vascular Solutions revenue increased approximately 5.3%. At first glance, this growth rate may seem lower than expected as Vascular Solutions had consistently been growing revenue in the double-digit range. We, however, are not concerned as the lower than normal revenue growth is primarily due to our decision to accelerate some distributor conversions from 2018, into 2017. As we saw in China with the Teleflex base business, when distributor conversions occur, there may be periods of time that revenue growth slows and that is what happened this quarter with Vascular Solutions as the European distributors' destock. We expect this to also be the case during the fourth quarter of 2017. And as such we, now expect Vascular Solutions to add about 8.5% towards Teleflex's full year revenue growth, which is at the low end of our initially provided range. We fully expect this to be short-lived issue and we continue to anticipate the Vascular Solutions will add close to a point of organic growth in 2018. Next, I would like to provide some additional color surrounding our segment and product-related constant currency revenue growth drivers. Vascular North America third quarter revenue increased 6.7% to $91 million, and was largely due to higher sales of PICCs and Vidacare EZ-IO and OnControl devices. As I have done in the past, I would like to point out that our PICC sales growth year-to-date is over 23% and our Vidacare year-to-date growth rate is over 19%. Moving to Anesthesia North America, third quarter revenue was $50.8 million, which was an increase of 4.3% (sic) [4.4%] (11:06) versus the prior year period. If you recall, Anesthesia revenue growth was relatively flat during quarter two, and the increase in quarter three is due to improvement in new product volumes led by our LMA Unique with silicone and LMA Gastro product lines as well as the Pyng acquisition. Turning to our Surgical North America business, its revenue decreased 2.7% to $40.8 million. As I referenced earlier, the decrease within surgical is primarily attributable to a decision to exit some lower margin product. Shifting to our overseas operations, EMEA revenues continued their positive trajectory, growing 3.3% on a constant currency basis to $131.5 million. The improvement in European revenue was largely the result of increased sales of vascular, surgical and cardiac products. Moving to Asia. Our third quarter revenue increased to 11.7% to $72.4 million. This marks the highest level of constant currency revenue growth achieved within Asia since the fourth quarter of 2015. The improvement in Asian revenue was largely the result of increased sales of cardiac, surgical and vascular products. As I communicated on our last earnings call, we expected China to contribute positively in quarter three, and it did, generating revenue growth of over 8.5% in the quarter. Turning to OEM. During the third quarter, revenues increased 16.1% to $48.6 million, and was primarily due to higher sales of catheter extrusions and performance fiber products. And lastly, third quarter revenue for the businesses within our All Other category was up 86.5%, totaling $99.6 million. Growth here is primarily attributable to the acquisition of Vascular Solutions. In summary, growth during the third quarter was balanced across our product lines and regions. And as we exit the year, it is our belief that we are well positioned for strong growth to continue into 2018. And speaking of strong growth, I would like to briefly speak to you about some recently completed M&A, including the closing of the NeoTract acquisition. We completed the acquisition of NeoTract on the first day of the fourth quarter; and as such, we will receive an entire quarters' worth of NeoTract results in 2017. For those of you who may not be aware, NeoTract was a privately held company, based in California, that has developed and commercialized the UroLift System, which is a novel, minimally invasive technology for treating lower urinary tract systems due to benign prostatic hyperplasia or BPH. With a revenue growth profile that exceeds that of Vidacare. This acquisition accelerates Teleflex's near-term sales growth trajectory and provides us with the significant sales channel opportunity. Most importantly, this acquisition enhances Teleflex's long-term organic growth profile and solidifies our ability to sustainably generate strong organic constant currency revenue growth in the future. NeoTract has experienced robust clinical adoption and significant revenue growth since initiating product commercialization in 2014, and this acquisition positions Teleflex to expand our current presence within the urological call point. Additionally, we expect this acquisition to enable us to improve our margin profile due to NeoTract's gross margin, which exceeds 70% today as well as allow us to capitalize on our significant international infrastructure to drive further penetration of NeoTract UroLift System outside of the United States. As background. During 2015 NeoTract generated revenue of approximately $18 million. This quickly accelerated to approximately $51 million during 2016. While during 2017, we continue to estimate that revenue will be between $115 million and $120 million and that it will grow at least 40% in 2018. We also continue to believe that NeoTract will be slightly delusive to adjusted earnings per share in 2017, that it will become breakeven in 2018. While in 2019, we expect that it will contribute between $0.35 and $0.40 of adjusted earnings per share and that it will be increasingly accretive, thereafter. I'm happy to report that the initial few weeks of integration have gone well, and we are very enthusiastic to have the NeoTract team, now part of the Teleflex family. However, NeoTract wasn't the only acquisition that Teleflex recently completed. On a much smaller scale, in September, we acquired certain assets from Tianjin Medical Company, Limited. This acquisition of a contract manufacturer based in Tianjin, China consists of substantially all of the assets used by Tianjin to manufacture a line of Teleflex laryngeal masks. This acquisition should assist our anesthesia business in being even more cost competitive, and it also provides Teleflex with a manufacturing presence within China, which should help as we attempt to get additional products through the Chinese version of the FDA. And finally, before I turn the call over to Tom, I would like to provide you with an update on our various restructuring programs. The non-revenue dependent margin expansion opportunity continues to be a differentiator for Teleflex as compared to many of our peers. And we continue to receive feedback from the investment community that they would like periodic updates and for us to summarize all the various restructuring programs in one place. That is what we are doing – we are once again attempting to do here. It is very important to understand that this chart simply represents the restructuring initiatives that have been approved and that are currently underway at the company and their respective costs and synergies. This does not include additional savings that we anticipate generating that come in the form of annual cost improvement programs, material substitution initiatives, improved pricing or potential future restructuring programs. These expected savings would be incremental to the amount shown here, and it is our intention at our Analyst Day next year to provide a comprehensive summary of all our expected savings over a forward-looking multi-year period. Our announced restructuring programs indicate that we expect to incur between $105 million and $125 million of total charges by the time these programs are complete; and that as of December 31, 2016, we incurred approximately $63 million of those costs. Turning to anticipated savings, we now expect that we will generate between $88 million and $102 million of annualized pre-tax savings and synergies by the time these programs are complete; and that through December 31, 2016, we achieved $31 million. This leaves us with between $57 million and $71 million of additional annual pre-tax savings and synergies yet to be realized, and it is our belief that we will realize substantially all of these estimated annual pre-tax savings and synergies by December 31, 2019. These savings and synergy figures represent an increase of between $4 million and $7 million as compared to our prior estimates. That takes me to the end of my prepared remarks. Now, I would like to turn the call over to Tom, for him to review our financial results for the third quarter and to provide our updated guidance for 2017. Tom?
Thomas E. Powell - Teleflex, Inc.:
Thanks, Liam. And good morning, everyone. Given the previous discussion of the company's revenue performance, I'll begin at the gross profit line. For the quarter, adjusted gross profit was $298 million versus $245.8 million in the prior year quarter. Adjusted gross margin was 55.7%, a 170-basis point increase when compared to the prior-year period. The expansion in adjusted gross margin was largely due to an increase in the sales of higher margin products, manufacturing cost reductions resulting from footprint realignment programs, and gross margin generated by the acquisition of Vascular Solutions. Operating margin improved 260 basis points to an all-time high of 26.3%. The improvement was related to gross margin flow through in tight control over discretionary SG&A spending. Adjusted net interest expense increased to $20.9 million from $11.7 million in the prior-year quarter. The increase will flexed the impact of the additional borrowings under our credit facility to finance the acquisitions of Vascular Solutions and NeoTract. For the quarter, the adjusted tax rate was 18.1%. This quarter's rate is somewhat elevated due to tax cost associated with the integration of Vascular Solutions and less favorable mix. The 390-basis point increase from the prior-year tax rate was also impacted by the prior-year comparable, which was a typically low. For the third quarter it was only a minimal benefit from the new accounting treatment or excess tax benefits. On the bottom line, third quarter adjusted earnings per share increased 17.8% to $2.12. Turning now to select balance sheet and cash flow highlights. During the first nine months of 2017, cash flow from operations was $320 million or an increase of 6% over the prior year. The increase was primarily the outcome of improved operating results, partially offset by an increase in net working capital. Also, during the quarter debt increased by $250 million as a result of $725 million draw on the revolver in connection with the acquisition of NeoTract, partially offset by the repayment of approximately $475 million of borrowings on the credit facility, and the retirement of the remaining $44 million of outstanding convertible notes. At quarter end, leverage as per our credit facility definition stood at 3.61 times. And that completes my comments in the third quarter. Now, I'll move to 2017 guidance updates. Beginning with revenue, as we look at the fourth quarter, we see two positive catalysts that allow us to raise both as reported and constant currency revenue growth ranges. First, our currency outlook has improved from when we last provided an update in August. Assuming currency rates remain at today's levels, foreign exchange would generate an approximate 75 basis point tailwind versus our previous expectation of a 100-basis point headwind. Second is the addition of NeoTract, which was not previously included in guidance. Consistent with our expectation when we announced the acquisition in September, we continue to project that NeoTract will generate full-year revenue of between $115 million and $120 million in 2017. We expect that the consolidation of the NeoTract results into our fourth quarter will add approximately 150 basis points, 170 basis points to our full-year revenue growth rate. As such, we are raising our as reported revenue growth in the previous range of 11.5% to 13% to new range of 15% to 15.5%. This revision to as reported growth represents an increase of 3% at the midpoint and reflects both the addition of NeoTract and our improved currency outlook. Based on the updated assumptions, our as-reported revenue is now expected to be between $2.148 billion and $2.158 billion. In addition, we are raising our constant currency revenue growth expectations from the previous range of 12.5% to 14% to a new range of 14.25% to 14.75%. Revision to our constant currency growth expectation represents an increase of 125 basis points at the midpoint and reflect both the addition of NeoTract and the adjustment of Vascular Solutions growth of 8.5% from our previous range of 8.5% to 9%. As discussed by Liam earlier in the call, the revisions of Vascular Solutions growth rate reflects the revenue impact of our decision to accelerate distributor to direct conversions into the fourth quarter. Moving to gross margin, we are raising our full year expectation for adjusted gross margin to a range of between 55.7% and 56%. The increase in our expectation is predominantly due to NeoTract. Turning to adjusted operating margin, here we are reducing our full year adjusted operating margin expectation to a range of between 25.3% and 25.5%. The change in adjusted operating margin reflects the inclusion of NeoTract in year-to-date performance. Shifting to interest expense, given the additional financing associated with NeoTract, we expect an increase in interest expense in the fourth quarter. As we have previously indicated, we may look to term out a portion of the revolving credit facility borrowings through a note offering. As such, we now project our full year 2017 adjusted interest expense to be between $80 million and $81 million. On taxes, we anticipate that our full year adjusted tax rate will be approximately 17%. And for modeling purposes, it is our expectation that foreign currency exchange rates in the fourth quarter will closely approximate recent spot rates. Our adjusted weighted average share count for the full year 2017 will be approximately 46.4 million shares. Finally, moving to EPS, given the year-to-date results and fourth quarter expectations, we are increasing 2017 adjusted earnings per share to a range of $8.30 to $8.40, or year-over-year increase of between 13.1% and 14.4%. The increase of $0.075 at the midpoint reflects a more favorable currency environment as compared to when we last provided guidance, somewhat offset by the addition of NeoTract, which is expected to be slightly diluted. In closing, I'm pleased with our year-to-date performance. Our growth year-to-date has been broad based and we are seeing improvement in several key metrics such as new product revenue. Our non-revenue dependent margin expansion is very much on track and we've been able to increase our earnings guidance for the third time this year. Additionally, the acquisitions of Vascular Solutions, the NeoTract will serve to further accelerate top line in earnings momentum. We look forward to a strong finish in 2017 and feel the company is well positioned for a successful 2018. That concludes my prepared remarks. Now, I'd like to turn the call back over to the operator for questions. Operator?
Operator:
Our first question comes from Larry Keusch of Raymond James. Your line is open.
Lawrence Keusch - Raymond James & Associates, Inc.:
Yeah. Hi, good morning, everyone.
Benson F. Smith - Teleflex, Inc.:
Good morning, Larry
Liam J. Kelly - Teleflex, Inc.:
Good morning, Larry.
Thomas E. Powell - Teleflex, Inc.:
Good morning, Larry.
Lawrence Keusch - Raymond James & Associates, Inc.:
So, I guess, Liam, maybe – I just want to start with the decision to accelerate these distributor conversions in the Vascular Solutions business. Could you really walk us through why you chose to do that differently than you had anticipated? Particularly, just given that you just close that deal earlier this year. So, I'm just curious why now?
Liam J. Kelly - Teleflex, Inc.:
So, Larry, good question. The reason that we would decide to do that now is because it's in our interest for the longer-term growth of the company. We, originally, anticipated that it would take longer to engage with the distributors in conversations about the go-direct. It normally, in our experience, takes a bit longer. But I guess given our history with LMA, Vidacare, the distributors were anticipating this and we got a bit of a lucky break as well, Larry, in all transparency in France, where one of the distributors was sold, which allowed us to begin the process. So, once we have begun that process, it opens up the door for us to have earlier conversations with the other distributors and what it means is we will have that direct channel within our control earlier in 2018, than we had originally anticipated, which bodes well for driving longer term growth for VSI in our own hands. So, that was the basis of the decision, Larry.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay, perfect. And then, just as a follow-up, I guess two thoughts here. First, given the acceleration in the organic constant currency growth versus the first half of the year. Can you give us some sort of preliminary thoughts on how you're thinking about that growth really for the core business? Not so much for NeoTract and Vascular. But as you look into 2018, and then, the only other thing is on the new products, which as you indicated were 2.1% growth. You didn't mention Percuvance in there. So, again, I just wanted to get a sense of, are you still sort of thinking that? You know, that's kind of $18-ish-million in 2018, and then, another 100 basis points of growth in 2019?
Liam J. Kelly - Teleflex, Inc.:
Okay, Larry, so I'll begin with the organic, and then, I'll turn to Percuvance, if that's okay? So, I think we're well poised for a very successful 2018. I think during the quarter two earnings call, I told the investment community to expect a slight uptick in our organic revenue growth in the second half of the year versus the first half. I think I also advised that China would become a tailwind in the second half contributing to that growth. It is still our expectation in quarter three, is very much in line with this. Our half year growth just for billing days and excluding scale acquisitions of 4.6% with organic at 3.8%, and if you look at the midpoint of our full year guidance that would have our full year growth excluding scale acquisitions of 4.4%; and organic at that 3.9%, up from 3.8%. So, Larry, to answer your question, we are expecting the uptake. I – again reiterated that our 4% to 5% full year revenue guidance included previously closed M&A. And also, looking into 2018, clearly, the headwind from the China go-direct will continue to be a tailwind. And we also think that the – we're very pleased with the new product acceleration and new product organic growth reaching 2.1% in the quarter, which as I said, was an all-time high for Teleflex. Percuvance didn't have any contributions into that new product revenue growth. And also in our quarter two earnings call, Larry, I mentioned that following the Percuvance recall, we expected to be back into the market during quarter three. As we dug into this with our third-party manufacturer, we identified additional issues. And as a result, we now anticipate being back in the market in early 2018. We are, of course, disappointed in this development especially since the customer demand and positivity towards the percutaneous product offering remains very high. But we're glad we caught it at this early stage. We will reengage with those customer trials and clinical evaluations once we are back in the market, and we will provide additional information of Percuvance expectations on our quarter four earnings call once we have more clarity. And again, we'll do the same in the spring at our Analyst Meeting. I would reiterate, Larry, we remain really enthusiastic for the longer-term prospect of this product. And again, as I said, we had an all time new product number of 2.1% revenue growth even without the contribution of Percuvance. So, I think it all bodes well for our longer-term outlook.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Terrific. Thanks very much, Liam.
Operator:
Our next question comes from David Lewis of Morgan Stanley. Your line is open.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Good morning. Just a few quick questions from me. The first is, Tom, just to follow up on VSI distributor conversion. So, with that acceleration in those distributor conversions, how are you thinking now about the VSI accretion for next year relative to the prior $0.50 guidance?
Thomas E. Powell - Teleflex, Inc.:
Well, we're obviously, to Liam's point, seeing this as a way to accelerate our efforts across Europe. I would say that we're not in a position to provide guidance yet for 2018, but you would expect it to be a positive versus a negative movement, obviously. Just a little premature for us to provide that guidance.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Okay. And then, Liam, just two for you. The first is, one if you just comment in the U.S. environment we've seen kind of U.S. implanter utilization growth in the third quarter be particularly weak, obviously your organic numbers are better than ours. But kind of comment on the U.S. environment, your thoughts into the fourth quarter, number one. And number two, on NeoTract, just given that 40% growth number for next year, if you can give us a sense of what you're assuming for the underlying investment in that business relative to specific rep hires, things of that nature would be very helpful. Thank you so much.
Liam J. Kelly - Teleflex, Inc.:
Yeah. Sure. So, David, I served in the U.S. Environment, and we have read the reports as well of utilization softness. Now, in all transparency, Dave, we are probably not the best company to be a benchmark on utilization. Most of our products are used in emergent procedures where the delivery of care is not optional. So, as the procedure volume goes down, we probably are the least impacted company in that regard because of our portfolio, and because of where we positioned our portfolio and the delivery of that emergent care as I said. Having said that, I mean, what we see especially through the third quarter is we see in the North American markets, utilization rates of our products continuing to grow modestly, and we don't see any pullback in utilization rates in the United States. So, that's our view of the market. Obviously, we're monitoring it pretty closely, and we don't anticipate seeing that into quarter four and to 2018. But as I said, Dave, we're probably not the best company to be a benchmark for that, we don't really track procedure volumes within hospitals. On NeoTract, clearly we're investing within this product category. Our investment thesis is that we will add a number of reps in the region of 8 reps to 10 reps again next year. As territories hit a tipping point, we will split the territories – we will either split the territories or add a consultant rep to assist the urology consultant within that territory to continue to accelerate the growth. And we – you're absolutely correct, we do anticipate generating 40% growth year-over-year, and we look at this very favorably.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Thank you very much.
Operator:
Our next question comes from Rich Newitter of Leerink Partners. Your line is open.
Richard Newitter - Leerink Partners LLC:
Hi, thanks for taking the questions. A couple of quick ones. Just maybe a follow-up on NeoTract, I think – thanks for the color there on 8 to 10 new rep hires. I was just wondering how the communication has been, kind of with the sales force and the existing employees of the organization since the deal announcement, just given this was a hypergrowth asset, and anytime, you have a standalone company like that get absorbed, is it going smoothly? Have you still retained the entire organization as is, and was there any distraction of any sort? I'm just curious.
Liam J. Kelly - Teleflex, Inc.:
Rich, thanks for the question. It's Liam. I'll take that. So, the initial integration has gone exceptionally well. I personally have been down there twice for signing and close. The people within NeoTract, I think see this very positively. We have had, I think one regrettable sales loss since close, but in all transparency that was a person that wanted to relocate. I think that would have happened whether it was part of Teleflex or not. The momentum within the company is still very solid. The sales team are very engaged. We are all committed to making the UroLift the standard of care for BPH, and the fact, I think that we have established it as its own business unit within Teleflex, obviously helps that, Rich, and it helps that team keep their own identity while being part of a bigger organization that obviously gives opportunities for future career growth within a larger company rather than a smaller. The management team is intact, Rich, and we don't envision significant changes in that regard either.
Richard Newitter - Leerink Partners LLC:
Okay. That's helpful. Just on Vascular Solutions, with respect to the pull forward distributor conversions, I appreciate that this actually is going to be a positive, likely benefit to your accretion assumptions in the year ahead, it is right to think that you're still thinking about – about 100 basis points of incremental growth on top of organic rate, and – or should that also kind of be thought of as an increasing pay-off as we move into 2018 as well?
Liam J. Kelly - Teleflex, Inc.:
So, again, we haven't given guidance for 2018, but as I said Rich, in my prepared remarks, we still believe that VSI can add a point to our top-line growth as a company. And as we do our Q4 earnings call and guidance, obviously, we'll give more color on what VSI will add to Teleflex.
Richard Newitter - Leerink Partners LLC:
Okay. But it's pretty clear that the VSI contribution in terms of what it can do for you in 2018, bottom-line and top-line, nothing has changed there?
Liam J. Kelly - Teleflex, Inc.:
That's a good assumption, Rich.
Richard Newitter - Leerink Partners LLC:
Okay, very helpful. One last one. On the China tailwinds that kind of picked up in the back half of 2017, can you quantify kind of those tailwinds just a little bit more, and then, also can you give us any quantification of whether that's kind of a run rate to think about as we move into the first half of 2018?
Liam J. Kelly - Teleflex, Inc.:
Well, if you look at the first half of 2018, I'll go back to what I said on the first of 2017, where China was a headwind of about 20 basis points, so obviously, we would see that going away, and we would see it becoming a – turning from a headwind to a tailwind in 2018. China had been a drag on our growth through the first three quarters, and in actual fact was – was negative in that timeframe, and it turned positive, China, so the tune of about 8.6% in quarter three. And we would see that continuing and accelerating slightly into quarter four in China.
Richard Newitter - Leerink Partners LLC:
Okay. Thank you.
Operator:
Our next question comes from Anthony Petrone of Jefferies. Your line is open.
Anthony Petrone - Jefferies LLC:
Thanks. And Benson congratulations, I don't know if you'll be with us on the fourth quarter call, but it's been a great ride and congratulations.
Unknown Speaker:
(39:55), he is going to be the CEO then. So, your perception that I won't be here is correct.
Unknown Speaker:
Right? Fantastic.
Anthony Petrone - Jefferies LLC:
Well, good luck. And thanks for everything. Two on NeoTract, and then, one on the restructuring target. So on just trying to walk through the math for the fourth quarter actually on what's actually baked in. So, I think by my math here you're baking in about $10 million, but the run rate on $115 million to $120 million seems to be much higher. So, maybe just to reconcile the fourth quarter contribution for NeoTract. And then, yeah, the update would be I think the shift in Medicare rates came out last night. I'm just wondering how it shook out for the UroLift CPT codes heading into 2018. What actually is the rate in 2017 and what will that rate be in 2018? And then, I'll have a follow-up on margins. Thanks.
Liam J. Kelly - Teleflex, Inc.:
Okay. So, with the – with the change, we didn't hear of any change that would happen for the CPT code for the UroLift, and so no adjustments to our reimbursement rate for that product. And our math is at the $1.5 million to $1.7 million would have NeoTract adding $28.5 million to $31.5 million in the fourth quarter.
Anthony Petrone - Jefferies LLC:
Got it. Got it. And on the margin front, I know we're – we'll get an update next year – in the spring at the Analyst Day. But I'm just wondering as you – as you look outward now and how this flows into margins, you know anything that that you could share on what the mix of maybe a margin of uplift will look like, you know between restructuring, gains going forward, mix, and perhaps even to the extent that price still plays into margin as a driver. Thanks.
Liam J. Kelly - Teleflex, Inc.:
Okay. And you're absolutely correct. We'll give longer-term guidance when we have our Analyst Day in the spring. I will tell you that we're very pleased that we're able to call up our longer-term benefit from restructuring by between $4 million to $7 million on this cause and that's a real positive for us. We do anticipate having modest positive core pricing and I think we're a little bit of a positive anomaly in that respect in Teleflex and we have been able to take a modest positive core pricing as well as pricing from our distributor to direct. And obviously, we have got continuous improvement programs in place. We have material substitution in place, and now, we have product mix playing in as well with VSI and NeoTract, having higher margins than our core portfolio. And then, making good decisions to exit lower margin portfolio as we did within our surgical business units. So, we will get further guidance on our Analyst Day, and I think the future looks bright for our margin expansion story.
Anthony Petrone - Jefferies LLC:
And just one last one...
Liam J. Kelly - Teleflex, Inc.:
Tom is just going to provide a little bit more...
Benson F. Smith - Teleflex, Inc.:
Just maybe a little more color, just if you think about the guidance we've provided in the last Analyst Day, through 2018 we still feel very confident in our ability to see the gross operating margin guidance even excluding the acquisitions of Vascular Solutions and NeoTract. In fact, we're kind of already at the operating margin target as we speak, including with acquisitions, and as Liam pointed out, as we look at NeoTract, it carries a higher gross margin than Teleflex and is growing very rapidly. We see that kind of in the low-70s gross margin. And as we look at the next-generation products, perhaps even increasing that margin. And so, we see that as a real margin driver going forward that would be additive to what we've provided previously. Vascular Solutions is also accretive on the gross and operating margin. We had mentioned in 2018, we expected to add 80 basis points to grow to 100 basis points into operating. So, both of those acquisitions will be additive to what we had previously communicated. And then, to Liam's point, we see pricing mix, other initiatives in operation such as our material substitution program continuing to build on that. And so, we see a multi-year margin expansion story still intact for Teleflex. So, we're pretty bullish and we'll provide more details on 2018 in the future at the Analyst Day.
Anthony Petrone - Jefferies LLC:
And what if I could sneak in is just back-end (44:25) for BARD, maybe just a comment on the tech market, and if you see any changes with the new ownership of BARD coming down? Thanks.
Liam J. Kelly - Teleflex, Inc.:
So, obviously, we're very focused on our own PICC portfolio that as I said is growing rapidly. We do – are very focused on the antimicrobial and anti-thrombogenic nature of our products, which clearly gives us an advantage. And through that, the three quarters, we're growing it over 25%, as I said, in my prepared remarks. Any integration of two companies of that size would cause disruption. We think that it may have a nice opportunity for us with some talent acquisition. And regardless of whether the two companies would unite, I think we're very well positioned to take share of BARD in its own or with BARD under BD. And we have just resubmitted our coded PICC in China, which we would anticipate getting that registration within 12 months. So, we're quite bullish about our opportunities within the PICC space as we compete with Baird and also AngioDynamics. And we also see that we have a positioning system that was formerly positioning system of another company and that gives us a good opportunities for continued growth in that segment.
Anthony Petrone - Jefferies LLC:
Thank you again.
Operator:
Our next question comes from Mike Matson of Needham and Company. Your line is open.
Mike Matson - Needham & Co. LLC:
Good morning. Thanks for taking my questions. I guess, I just wanted to start with the divestitures that you spoke about of some of the lower growth and lower margin businesses. I know you're probably not going to tell us what other areas you're looking out there, but can you just talk about how much opportunity you have to continue to shed some of these types of things?
Liam J. Kelly - Teleflex, Inc.:
So, let me just say your assumption about us, of our not telling you what other businesses are on the target list is absolutely correct. I think our broader operating philosophy has been that as we are making acquisitions, like Vascular Solutions and NeoTract, it puts us in a position to be able to take a look at additional things in our business portfolio which may not have the same strategic importance to us – maybe lower growth, lower gross margin products, less lined up in a good competitive network. So, that's kind of the framework at which we're looking at it, the attractiveness of the interest to another buyer is obviously another thing. So, much beyond that, we're really not able to comment, other than don't be surprised if we do so more of this.
Mike Matson - Needham & Co. LLC:
Okay, that's helpful. And then, with regard to Vascular Solutions, just wondering if you continue to see double-digit growth in the areas where you weren't going through these distributor transitions, it sounded like that was mostly in Europe. So, I don't know, maybe the question would be, did the U.S. grow double digits or if some of that was going on here than any area where you didn't go through those issues?
Liam J. Kelly - Teleflex, Inc.:
So, that the U.S. was in line with our expectations, we saw an uptick year-to-date was slightly ahead in APAC. And you're absolutely correct, most of the impact was in Europe. And what happens? Clearly, the distributors we end – we begin the conversations with the distributors on a go-direct. So, they stop ordering, they're not going to order product and have it sitting in their warehouse for us to buy it back and just ties up cash for them. So, the impact was almost exclusively seen within Europe from a degradation standpoint and the U.S. was in line with our general expectation.
Mike Matson - Needham & Co. LLC:
Okay. Thanks. Maybe if I could squeeze one more, just on China. It seems like the government there is really pushing to buy from local manufacturers. So, does that concern you at all and did that factor into your decision to buy this company there at all?
Liam J. Kelly - Teleflex, Inc.:
So, the decision to buy the company in China has very little to do with that particular phenomenon. As I said in my remarks, it will actually help us get through this – Chinese FDA for some product categories. But the decision to buy that company was really to solidify our supply chain for our fast growing LMA with silicone product, which is one of our new products and it was manufactured by that company Tianjin (48:57). So, it will help with our margin profile, it will help with our ability to continue to grow that product in North America. And I think that you are right that the Chinese government is giving preference to local manufacturers. But that has been happening for the last two years and we've addressed that with very differentiated products within our portfolio that are not easy to substitute in that marketplace.
Mike Matson - Needham & Co. LLC:
Thank you.
Liam J. Kelly - Teleflex, Inc.:
Thanks, Mike.
Operator:
Our next question comes from Matthew Mishan of KeyBanc. Your line is open.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Hey, good morning, and thank you for taking the questions.
Liam J. Kelly - Teleflex, Inc.:
Good morning.
Benson F. Smith - Teleflex, Inc.:
Good morning.
Thomas E. Powell - Teleflex, Inc.:
Good morning.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Just a lot of moving pieces now. And I was just hoping you could just go back to the core organic constant currency growth rate, that 4% to 5% guidance you gave. And talk around what you're seeing around just the core organic growth. Are you coming in near the high end, the low end, or how are you feeling about the core business?
Liam J. Kelly - Teleflex, Inc.:
Okay, Matt. So, if we go back to the 4% to 5%. The 4%, 5% did include previously completed M&A in our guidance, which we gave at the beginning of the year. Now, if we go back to where we're performing versus that. And if you take our constant currency guidance of 14.25% to 14.75%. You take out VSI and you take out NeoTract, and you normalize our billing days and do all that. You are at a range of call it 4.25% to 4.55%, with a midpoint of 4.4%. So, that's a comparative to our guidance, and then, our original guidance would insinuate or give you an organic growth of 3.7% to 4.6% at the midpoint of over 4.1%, and our current guidance would give you 3.75% to 4.05% with the midpoint of about 3.9%. So, all in all, those are the moving pieces, and clearly, we exited some lower margin business, as I – which I said in my prepared remarks as a headwind of about 20 basis points all coming in the second half of the year for the 20s of full year basis. So, we're very comfortable where we are in relation to our guidance and very comfortable where we are in relation to our organic growth. And obviously, a key component to that is new product, which we continue to see acceleration on.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Okay, got it, that's really helpful. And then, I know you're not given guidance for next year, but I think you're going to do, I think you're looking to do a high yield offering. What do you think the full – the right run rate for interest expense going into next year is? I mean, I know the fourth quarter won't be the full run rate, but what do you think the right run rate is going into next year?
Liam J. Kelly - Teleflex, Inc.:
So, you're right, given the offering would be midway through, it would be slightly elevated from what we're seeing in the fourth quarter. I don't have the exact number calculated as of yet, but...
Thomas E. Powell - Teleflex, Inc.:
Yeah, and, Matt, and it's obviously somewhat dependent on when we do the offering and what rate we end up getting on the offering. So, I'm sure that following the completion of a note offering, we'll certainly be able to communicate more with investors as to what our longer-term run rate would be for interest expense.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Okay, and great. And then, last question, on Vascular Solutions, anyway you can break out the North American growth versus the international to get a sense for what the real impact of the distributor direct issues are, as compared to like your ability to drive growth in North America?
Liam J. Kelly - Teleflex, Inc.:
So, Matt, I said earlier that North American growth was in line with our expectations. I mean, the impact, we estimate the impact of the distributor destocking in Europe to be about $2.5 million and further destocking that will happen in the fourth quarter as we have these conversations. The important thing here, Matt, is that destocking takes place accelerates our opportunities in 2018 for the go-direct. So, it's a short-term headwind, but it's a longer-term positive for Teleflex.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Okay, understood. All right. Thank you very much, and congratulations.
Liam J. Kelly - Teleflex, Inc.:
Thank you.
Operator:
Our next question comes from Brian Weinstein of William Blair. Your line is open.
Andrew Brackmann - William Blair & Co. LLC:
Hey, guys, this is actually Andrew Brackmann on for Brian this morning. I want to go back to the distributor conversion and could you maybe talk a little bit more about your pipeline and runway that you have here and when do you think it will be kind of materially done? Thanks.
Liam J. Kelly - Teleflex, Inc.:
Okay, Andrew. So, we have said in the past that about 8% to 9% of our business is a potential for a go-direct, and of that, about one-third, it would be attractive to is then would be in geographies that we would consider. Obviously, we've executed in China, at the same time we did the VSI acquisition, which almost refills the bucket with the exact same value. So, the original statement still holds. Obviously, now we will execute in 2018, on a significant portion of the VSI go-direct, which will bring down that overall percentage. But we still are constantly looking at opportunities for our go-direct, and there are still some parts of the world that we think we should execute on in the next coming years.
Andrew Brackmann - William Blair & Co. LLC:
Got it. Thanks. And then, one more, last quarter you had made some comments around some competition headwinds in your lower end respiratory products. Are you still seeing that in the third quarter or is that kind of material behind you? Thanks.
Liam J. Kelly - Teleflex, Inc.:
Thank you. Actually, the comments that we made, Andrew, were around our anesthesia portfolio, and I'm happy to be able to comment that our anesthesia portfolio had a very solid quarter, three growing at 4.3%, driven predominantly by new product introductions, the LMA with silicone that I spoke about earlier, the LMA with Gastro, and also the Pyng acquisition that we introduced in the intraosseous space in that group. So, we – there's always competition in parts of our business. But I think we're managing some of that competition very well.
Andrew Brackmann - William Blair & Co. LLC:
Thanks, guys.
Operator:
Our next question comes to Matt Taylor of Barclays. Your line is open.
Matthew Taylor - Barclays Capital, Inc.:
Hi, good morning, guys. Thanks for taking the questions.
Liam J. Kelly - Teleflex, Inc.:
Good morning.
Matthew Taylor - Barclays Capital, Inc.:
Good morning, guys. So, I wanted to ask you about next year. I mean if we look at how things are improving here organically and with these acquisitions and FX is going your way, you have a lot of tailwinds going into 2018. And I guess I'm just curious philosophically how much of that you would drop through versus reinvest when – if we add up kind of that contributions from each of those things, you could easily grow above kind of this low to mid teens rate on earnings that you've been growing. So, how do you balance those things?
Liam J. Kelly - Teleflex, Inc.:
So, clearly, Matt, there are some areas of investment that we have identified within Teleflex. NeoTract, as we have always said was an investment thesis for Teleflex, we will continue to invest in particular in the sales channel in NeoTract. The go-directs in Europe will require some investment, and I think we did alert the investment community that we will begin that investment in the latter half of the year in anticipation of the go-direct. But we will have to put sales resources into Europe to support the growth that we anticipate from VSI in Europe. And obviously, there are parts of our portfolios that are fast growing, like the intraosseous with Vidacare and now with Pyng, that we would put resources. But we're – our philosophy on investment, Matt, is we invest behind our highest margin, fastest growing assets in order to drive ongoing shareholder value. So, that is our philosophy in order to continue to accelerate Teleflex's growth profile.
Matthew Taylor - Barclays Capital, Inc.:
Okay. Great. And I just wanted to clarify, you said earlier on the call you're analyzing the potential impact of some suppliers in Puerto Rico. It sounded like that would be pretty small, is there any way that you can give us some brackets around what the quantification of that impact would be?
Liam J. Kelly - Teleflex, Inc.:
You're correct, it's pretty small, Matt, but at the same token, we're just keeping a very watchful eye. We have some components that go into our kits that come out of that geography. And also, we are watching very closely what happens to the price of PVC, not because of the hurricane per se on providers down there, but the demand for PVC will go up as the building industry increases its demand for that raw material. So, we're watching that closely to see if that's going to have a cost impact, but that will impact every medical device company that uses PVC, not just Teleflex, so we don't see it is as being significant, and we didn't see the hurricanes as having a significant impact on our revenue growth in Q3.
Matthew Taylor - Barclays Capital, Inc.:
Okay. All right. Thank you very much.
Operator:
Our next question comes from Dave Turkaly of JMP Securities. Your line is open.
David L. Turkaly - JMP Securities LLC:
Hi, thank you. I, too, would like to congratulate you, Benson. It's been a great run.
Benson F. Smith - Teleflex, Inc.:
Thanks, Dave.
David L. Turkaly - JMP Securities LLC:
Sure. Quickly, the Percuvance thing. Obviously, we've done some diligence on that product, it seems like there is some good pent-up demand, some people that are using it fairly frequently, I'm just curious the issue that arose as a new one that delays you to 2018, like is that a manufacturing problem or what exactly happened or is happening with the product?
Benson F. Smith - Teleflex, Inc.:
Yes, it's a manufacturing specification problem with our third-party provider of some of the products. So, we're working with them to get a root cause. We think we're pretty close and we anticipate being back early in 2018. We agree with you, the customer sentiment is very, very strong. There's a lot of pent-up demand for the products. Our sales force are just waiting to get it back, so they can go back to that customer base with the product. So, we're really looking forward to getting it back in the hands of our sales reps and back to the customers who really want to use this products early in 2018.
David L. Turkaly - JMP Securities LLC:
Great. And one quick follow-up. I know you mentioned PICC positioning as sort of a driver, maybe even for competitive gains. But are you still selling – I think it was Nostix and VasoNova, but are both of those still being used and/or any color on sort of which is more prominent or which is helping you on the competitive landscape?
Benson F. Smith - Teleflex, Inc.:
So, we still sell both. We have a good, better, best philosophy. The VasoNova portfolio gives a nurse who is placing a PICC, a confirmation that the PICC is in the right position. The Nostix gives us guidance and for countries in particular overseas where they just want to use ECG, it allows them to use ECG. I would anticipate that the – and the preloaded Nostix product is now just into the marketplace. But I would anticipate the growth profile, the accelerated growth profile could come more from Nostix than from the VasoNova, but like all products in this category, would you start to take market share? You'll actually get a bounce on both categories and both should see growth. But the Nostix is more comparable to what the physicians are used to using in the marketplace. So, therefore, that's why anticipate that gaining momentum and it has some real competitive advantages over some of the systems out there.
David L. Turkaly - JMP Securities LLC:
Thanks a lot.
Operator:
There are no further questions. I'd like to turn the call back over to Jake Elguicze for any closing remarks.
Jake Elguicze - Teleflex, Inc.:
Thanks, operator, and thanks to everyone that joined us on the call today. This concludes the Teleflex Incorporated third quarter 2017 earnings conference call.
Operator:
Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program and you may all disconnect. Everyone, have a great day.
Executives:
Jake Elguicze - Teleflex, Inc. Benson F. Smith - Teleflex, Inc. Liam Kelly - Teleflex, Inc. Thomas E. Powell - Teleflex, Inc.
Analysts:
Lawrence Keusch - Raymond James & Associates, Inc. Scott S. Wang - Morgan Stanley & Co. LLC Matthew Mishan - KeyBanc Capital Markets, Inc. Mike Matson - Needham & Co. LLC Chris Cooley - Stephens, Inc. David L. Turkaly - JMP Securities LLC Matthew Taylor - Barclays Capital, Inc. Ravi Misra - Leerink Partners LLC
Operator:
Good day, ladies and gentlemen, and welcome to the Second Quarter 2017 Teleflex Incorporated Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. As a reminder, this conference call is being recorded. I would now like to turn the conference over to Treasurer and Vice President of Investor Relations, Jake Elguicze, you may begin.
Jake Elguicze - Teleflex, Inc.:
Good morning, everyone, and welcome to the Teleflex Incorporated second quarter 2017 earnings conference call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing 855-859-2056 or for international calls, 404-537-3406, passcode, 56173289. Participating on today's call are Benson Smith, Chairman and Chief Executive Officer; Liam Kelly, President and Chief Operating Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Benson, Liam and Tom will provide prepared remarks and then we'll open up the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today, as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. With that, I'd like to turn the call over to Benson.
Benson F. Smith - Teleflex, Inc.:
Thank you, Jake, and good morning, everyone. First of all, we are pleased with our second quarter and year-to-date 2017 results and our continued progress on many of our long-range initiatives. After six months, we're spot on on our constant currency revenue expectations. On top of that, we are benefiting from a more favorable currency environment that has a positive impact on our as-reported revenue and our adjusted EPS. Here are some details. From a year-to-date standpoint, our constant currency revenue growth including Vascular Solutions was 14.4%, as compared to our full-year guidance range of 12.5% to 14%. If you were to exclude Vascular Solutions and normalize for the impact of shipping days, our constant currency revenue growth for the first six months of the year totaled 4.6%, as compared to our full-year guidance range of 4% to 5%. That puts us right on track towards the achievement of our previously provided full-year constant currency revenue growth guidance range. We've continued to achieve strong results across many of our strategic business units and geographies. And this performance, coupled with our expectations for the remainder of the year, has allowed us to increase our full-year as-reported revenue growth and adjusted earnings per share guidance ranges. Turning to our quarterly results and beginning with revenue. Despite having one fewer shipping day in Q2 as compared to the prior year period, revenues grew 11.6% on an as-reported basis and 12.9% on a constant currency basis. This includes the contribution from Vascular Solutions product lines, which accounted for approximately 9.6% of our constant currency revenue growth. I'm happy to report that year-to-date Vascular Solutions performance has been in line with our initial expectations and that we have an opportunity to accelerate some distributor conversions efforts into the latter part of 2017 that were originally planned for 2018. As such, we will be making some additional investments in the second half of 2017 to accomplish this. During Tom's prepared remarks, he will go through this in a bit more detail. Setting aside the impact of Vascular Solutions and one fewer shipping day that impacted our results in the quarter, Teleflex posted good growth on a constant currency basis, driven by the performances of Vidacare, which grew approximately 17%, as well as our OEM Vascular North America, Surgical North America and EMEA segments. We continue to see stability within our end markets, good global utilization of many of our products and positive momentum in revenue generated through newly introduced products into the market. We also made significant progress on our distributor conversion in China, and as such, we anticipate an acceleration of constant currency revenue growth in the second half of the year as compared to the headwind of revenue of approximately 60 basis points that we experienced during the first half of 2017. Turning to profitability, during the second quarter, we generated adjusted gross, in operating margins of 55.9% and 25.1%, respectively. The operating leverage generated in Q2 translated into adjusted earnings per share $2.04, which is an increase of 7.9% versus the second quarter of 2016. It is also better than our prior expectations for Q2, which called for adjusted earnings per share to be relatively flat to the year ago period. Finally, during the first six months of 2017, the company continued to generate strong free cash flow and has enabled us to repay borrowings that were equivalent to approximately 10% of the Vascular Solutions purchase price within only a few months after closing the transaction. In summary, we're off to a good start in 2017 and are on track to meet or exceed the original 2017 financial targets that we provided the investment community in February. Additionally, I believe we made good stride to many key areas that will position us well for 2018. That completes my prepared remarks, and I would now like to turn the call over to Liam.
Liam Kelly - Teleflex, Inc.:
Thank you, Benson, and good morning, everyone. For the consolidated company, second quarter 2017 constant currency revenue grew 12.9%. During quarter two, we had one less shipping day, as compared to the second quarter of 2016 and this negatively impacted our results by approximately 1.2%. When normalizing for the shipping day impact, sales volumes of existing products grew 1.4%. Also impacting volumes in the quarter was our decision to go direct within China, which resulted in our former mass distributor of vascular and cardiac goods to no longer purchase product from us. This caused the volume growth shown here to be adversely impacted by approximately 60 basis points. However, as Benson just mentioned, we made good strides in our efforts to build out our direct sales capabilities in China during quarter two and we anticipate that China will no longer be a headwind in quarter three, and then become a revenue tailwind during quarter four. Moving to new products, the positive revenue contribution trend we have seen for the past several quarters once again continued, this time, contributing approximately 1.5% of constant currency growth, squarely in line with our full year guidance expectations. New product revenue growth was once again led by our vascular, surgical and anesthesia product lines. Vascular new product revenues increases are attributed to further penetration of our preloaded antimicrobial and anti-thrombogenic VPS PICCs. While in Surgical, new product growth was primarily due to sales of our EFx and Ae05 products. Finally, anesthesia new product revenue growth is primarily due to increased sales of our LMA unique product with silicon. Turning to pricing. During quarter two, we saw continued improvements in the average selling price of our products, which drove revenue higher by another 60 basis points. This is consistent with the levels that we achieved during quarter one, and the ability to continue to drive positive pricing continues to be a differentiator for Teleflex. Finally, moving to revenue growth coming from M&A. During the quarter, M&A, other than Vascular Solutions, contributed approximately 1% towards our constant currency revenue growth. The contributors here were CarTika and Pyng, with a larger portion coming from CarTika. I would like to point out that both CarTika and Pyng are growing their revenues organically at high rates and will help Teleflex accelerate its organic constant currency revenue growth rate moving forward. Finally, Vascular Solutions contributed 9.6% towards Teleflex's second quarter constant currency revenue growth. And when compared to the second quarter of 2016, Vascular Solutions continued its track record of double-digit growth, increasing approximately 10%. I'd like to point out that Vascular Solutions also had one fewer shipping day in quarter two, so its normalized revenue growth would have been about 11.5%. Growth in Vascular Solutions was primarily due to increased sales of Turnpike, GuideLiner and micro-introducer kit products. And before I talk about the constant currency revenue growth rates of our segments, I would like to briefly share with you how the same metrics I just reviewed with you look like on a year-to-date basis. Many of these numbers are similar in nature to the figures I just shared with you for quarter two and the reason why I want to highlight these year-to-date figures are two-fold. First, they show that we are on track towards the achievement of our full-year constant currency revenue guidance range of 12.5% to 14%. And second, I would like to share with you what you should expect to see in terms of second half of the year performance as compared to these figures. For the first six months of 2017, core product volumes, normalized for the extra shipping days, grew 1.4%. This 1.4% includes the negative headwind of 60 basis points because of China, as I just mentioned a few moments ago. As we move forward in the second half of 2017, we expect China to be a tailwind to revenue growth and, as such, we would expect core product volumes, excluding the impact of shipping days, to accelerate in the second half of 2017 as compared to the 1.4% during the first half. Moving to new products, growth generated by new products added 1.7% for the first six months of 2017. As we move towards the back half of the year, we would expect a modest uptick, as we get the benefit from products launched in late quarter two, such as AC3 and VPS Rhythm. Turning to price, it contributed about 70 basis points year-to-date, and during the second half of 2017, we expect it to be a tad lower, but not in a large respect. Moving to contributions from M&A other than Vascular Solutions. During the first six months of the year, this has added 0.8%. Looking forward, we expect this to be a bit lower as the CarTika acquisition anniversaries itself. However, beginning in September, CarTika revenue growth will be included as core product volume growth. And given CarTika's organic growth rate, this is yet another reason why we expect our core product volume growth to improve moving forward. And before I move to Vascular Solutions, I would like to reaffirm a point made by Benson earlier, which is that at the half-year mark, our constant currency revenue growth, excluding Vascular Solutions and adjusted for shipping days, is 4.6% compared to a guidance range of 4% to 5%. We feel very comfortable with our revenue guidance including and excluding Vascular Solutions. Now, on to Vascular Solutions itself. During the first six months of the year, it added 7.5% towards our overall constant currency revenue growth. In the last six months of the year, we would expect Vascular Solutions to contribute growth rates closer to the level it contributed in the second quarter. And finally, I wish to outline what to expect in terms of the shipping day impact. If you recall, we had a five-day benefit in quarter one and one fewer day in quarter two. As we move forward, we will not have any shipping day impacting quarter three, but we will have five fewer days in quarter four. As such, we expect the lack of shipping days to negatively impact us in quarter four. To date, we've estimated that each shipping day has impacted our business by approximately 1.2%. In summary, we feel that we have good visibility into our revenue growth trajectory in the back half of 2017. Next, I would like to turn back to the quarter and provide some additional color surrounding our segments and product-related constant currency revenue growth drivers. Vascular North America second quarter revenue increased 6.3% to $93.5 million. The increase in Vascular revenue was largely due to higher sales of PICCs and Vidacare EZ-IO and OnControl devices. The underlying growth in this segment was somewhat muted by the impact of one fewer shipping day within the quarter. Moving to Anesthesia North America, second quarter revenue was $49.1 million, or essentially flat versus the prior year period as increases in revenue from new product sales and the impact of an acquisition was offset by a decrease in sales volume of existing products, in part because of one less shipping day. Turning to our Surgical North America business, its revenue increased 4% to $44.7 million. The increase within Surgical is primarily attributable to higher sales of access ports, surgical instruments, and percutaneous products. And like our Vascular and Anesthesia businesses, growth within Surgical was also negatively impacted by one fewer shipping day. Shifting to our overseas operations. EMEA revenues continues their positive trajectory, growing 3.2% on a constant currency basis to $132 million. The improvement in European revenues was largely the result of increased sales of vascular, interventional, surgical, and cardiac products. Like our North American franchises, growth in this region was also negatively affected by one less shipping day. Moving to Asia. Our second quarter revenue increased 3.1% to $64 million. This region was not impacted by shipping days; however, the China go-direct limited revenue growth in the quarter. Without that, this region would have grown approximately 7.5%. Turning to OEM. During the second quarter, revenue increased 12.5% to $45.1 million, and was primarily due to higher sales of catheters and performance fiber products, as well as the CarTika acquisition. And lastly, second quarter revenues for the business within our All Other category was up 73.1%, totaling $100.2 million. Growth here is primarily attributable to the acquisition of Vascular Solutions. In summary, growth during the second quarter was balanced across our product lines and regions, and had it not been for the shipping day, growth in our North American and EMEA product lines would have been about 1.6% higher, respectively. And as has been our customary practice, I would like to next briefly update you on the status of GPO and IDN Awards as well as some recently received regulatory approvals and product launches. Adding to the success we realized in the first quarter, during quarter two we won an additional six new GPO and IDN agreements and extended 16 others. Of the agreements won and extended in quarter two, 14 were sole source in nature and covered a wide variety of clinical areas, including our CVC catheters, laryngeal masks, ligation clips, and our percutaneous product offerings. Moving next to some recent product introductions and regulatory approvals which we've received. Starting with our most recent arterial catheter. We recently received 510(k) clearance for the Arrow Seldinger Arterial Catheterization device. This device is indicated for short-term use, and is designed to improve patient safety by eliminating confusion of catheter identification, while also reducing the risk of complications associated with insertion. It also provides optimal diagnostics, leading to effective treatment for patients; and we expect to launch this product in the United States later this year. Turning to next to RePlas. We are quite enthusiastic about this product, and for those of you who are not familiar with it, RePlas is freeze-dried plasma. This product came to Teleflex via the Vascular Solutions acquisition, and it is a product that has been developed in cooperation with the U.S. Army. The U.S. Army is sponsoring the clinical trials of the freeze-dried plasma for the treatment of battlefield trauma and other emergency applications. However, Teleflex retains all rights to commercialize RePlas. On May 15 of this year, Teleflex announced the commencement of a Phase I clinical study whereby RePlas was administered to the first patient as part of a 24-patient study being conducted at Hoxworth Blood Center at the University of Cincinnati. In this first stage of the clinical development program, healthy volunteers receive increase dose of their own blood plasma that has been processed using our proprietary freeze drying and packaging techniques to assess safety and tolerability. We continue to expect that we will commercially launch RePlas during 2020 and that it could be a $100 million product opportunity over time for Teleflex. That takes me to the end of my prepared remarks. At this time, I would like to turn the call over to Tom for him to review our financial results for the second quarter and provide an updated guidance for 2017. Tom?
Thomas E. Powell - Teleflex, Inc.:
Thanks, Liam, and good morning, everyone. Given the previous discussion of the company's revenue performance, I'll begin my prepared remarks at the gross profit line. For the quarter, adjusted gross profit was $295.3 million versus $260.4 million in the prior year quarter. Adjusted gross margin was 55.9%, a 90 basis-point increase when compared to the prior year period and representing the highest adjusted gross margin level achieved by Teleflex since becoming a pure-play medical device company. As covered on our last earnings conference call, given the top gross margin comparables in the second quarter of 2016, we are expecting only modest gross margin expansion for the second quarter of 2017. So the result is modestly favorable to our previous expectation. Versus prior year, adjusted OpEx spending grew by approximately 15%, reflecting the inclusion of Vascular Solutions and expenses associated with the China distributor conversion. Adjusted operating margin was in line with prior year at 25.1%. Adjusted net interest expense increased to $19.4 million from $10.3 million in the prior year quarter. The increase is the result of the additional borrowings used to finance the acquisition of Vascular Solutions. For the quarter, the adjusted tax rate of 16.6% marks a 400 basis point reduction from the prior year rate. More than anything else, the year-over-year reduction is a result of an easy comparable from the prior year. For the second quarter, the tax benefit of the new accounting treatment for excess tax benefits from stock plans was minimal. On the bottom line, adjusted earnings per share increased 7.9% from $1.89 in the second quarter of 2016 to $2.04 in the second quarter of 2017. Turning now to select balance sheet and cash flow highlights. During the first six months of 2017, cash flow from operations was $198 million, for an increase of 9% over the prior year. The increase was primarily the outcome of improved operating results and working capital management. Also during the quarter, we repaid approximately $90 million of bank debt, which resulted in a reduction of gross leverage to approximately 3.3 times at the end of the second quarter. Finally, post quarter end, we retired the remaining $44 million of outstanding convertible notes. Cash requirements for the retirement were funded through revolver borrowings. That completes my comments on the second quarter. Now I'll move to 2017 guidance updates. Through the first six months, our operating performance is tracking in line with expectations and the Vascular Solutions integration is proceeding as planned. We do, however, see two positive changes that allow us to raise our as-reported revenue guidance and our adjusted EPS guidance. The first positive change is from currency. Currency rates have improved from where we set our original guidance expectations, which has resulted in less of a headwind to both our as-reported revenue growth and adjusted EPS for fiscal year 2017. Our original 2017 guidance assumed a $0.30 headwind to adjusted EPS. We now expect the headwind to be $0.13, or a $0.17 improvement. The second positive change is in interest expense. Our original guidance had assumed that in order to more permanently finance the Vascular Solutions acquisition, we would term out approximately $500 million of revolver borrowings with a high-yield note offering. This financing was expected to be completed midway through 2017. After reassessing our projected sources and uses of cash, we no longer anticipate the need to term out the revolver borrowings related to the Vascular Solutions acquisition. The stable interest expense impact of the revised capital structure plan will now be reflected in our updated 2017 adjusted earnings per share guidance. We also believe that we are now in a position to potentially accelerate investment in Vascular Solutions distributor to direct conversions into the second half of 2017, which will help us get a jump on 2018. As such, as we finalize our planning in this area, we will hold a portion of the interest expense savings as a reserve to fund this potential investment. Let me now walk you through how these changes impact guidance, beginning with revenue. For 2017, we are reaffirming our full year constant currency revenue growth guidance range of 12.5% to 14%. We continue to assume that our base business will grow 4% to 5% and that Vascular Solutions will add 8.5% to 9% to total growth. However, we are raising our as-reported revenue growth guidance from the previous range of 10% to 11.5% to a new range of 11.5% to 13%, so the 150 basis point increase in as-reported revenue growth is the outcome of our improved expectations for 2017 currency environment. Based on our updated currency assumptions, we now expect as-reported revenue to range between $2.083 billion and $2.111 billion, or an increase of approximately $28 million from our previous as-reported revenue guidance. Moving to interest expense. As mentioned, our original guidance assumed a mid-year high-yield financing to term out the Vascular Solutions acquisition. The deferral of this financing will reduce the interest expense in the second half of 2017 by approximately $6 million as compared to our initial expectations. Turning now to EPS. Given the favorable developments, we have increased the bottom-end of our adjusted EPS guidance range by $0.15 and the top end of the range by $0.12. Our current outlook for fiscal year 2017 adjusted earnings per share is now a range of $8.20 to $8.35, up from our previous outlook of $8.05 to $8.23. Our assumptions on constant currency revenue growth, adjusted gross margin, adjusted operating margin and adjusted tax rate remain unchanged from the last quarter. So, in summary, through six months of 2017, Teleflex is off to a good start. Constant currency revenue growth, gross margin, and operating margin are spot on where we expected them to be. The integration of Vascular Solutions is also progressing as planned. During the second quarter, we repaid $90 million of bank debt and reduced our gross leverage to approximately 3.3 times. And subsequent to quarter end, we retired the remainder of all convertible notes outstanding. We have had two positive changes in the form of an improved currency environment and the deferral of a planned high-yield notes offering, which provides us the flexibility to make investments to accelerate the Vascular Solutions integration timeline and to once again raise EPS guidance. That concludes my prepared remarks. At this time, I'd like to turn the call back over to the operator for questions. Operator?
Operator:
Thank you. Your first question is from Larry Keusch with Raymond James. Your line is open.
Lawrence Keusch - Raymond James & Associates, Inc.:
Thanks, everyone. Good morning. So, just a couple of quick things here. Could you maybe talk a little bit about China, and obviously I understand the impact is tracking to your expectations, but could you expand a little bit more on sort of the infrastructure build that you've had to do? And I guess your visibility on how much of the distributors' products are still out there in the channel, as you think about the second half? And then, I had one other question.
Liam Kelly - Teleflex, Inc.:
Okay. Hey, Larry. It's Liam here. I'll take this. Regarding the build out of our infrastructure, we have appointed regional distributors. So we actually have all of the regions covered and we've also appointed close on 93 sub-distributors that will obviously get product to the market. We had a review recently on our sales out, which is the benchmark you want to have in China, sales to the end customer. We're progressing modestly ahead of our expectations in that regard, so that's quite encouraging for us. We have our infrastructure from a talent acquisition point of view, almost completely in place. We only have four positions that we haven't made an offer on or have the person on board, so we're really comfortable with where we're at. We're currently going through a mediation process with the distributor and they've filed some documents outlining their inventory levels. We are currently reviewing that. It's difficult for us to tell exactly how much is left within their portfolio. But given the fact that they have continued to sell for this period of time, we would expect that to be pretty modest at this stage, what's left with the distributor, Larry.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Terrific. And then, just one other quick question. I couldn't help but notice the strength in the EMEA region, and I think we saw that beginning in the first quarter as well. So maybe again, if you can expand a little bit on what you think is going on there, and how sustainable could that improved growth be, because I think, you were sort of flattish in the path there. So this marks definitely a nice step-up.
Liam Kelly - Teleflex, Inc.:
So last year, we grew in EMEA, Larry, by about 1.1%, and this definitely showed the step-up, and the step-up is pretty broad based in the geographies within EMEA. Adjusted for billing days, we're at 4.8% within this quarter. And, as I said, it's broad based; so we've seen nice recovery. Germany was always pretty strong, but we've started to see nice recovery in France, we've seen nice recovery in the UK, Italy and Iberia. And also in the indirect markets in Saudi Arabia, they seem to have overcome some of the oil crisis there, and that has helped us as well, Larry. So the encouraging thing is that it's broad based, and the economies are doing better there, as we all know. So, yeah, we're really encouraged by what's happening within EMEA. And also some of our new products were getting out there into the market, are driving increased demand and we're getting better utilization.
Benson F. Smith - Teleflex, Inc.:
Right. I think there is also some pent-up demand, some of the fact that they had cut back on expenditures for several years, and you can only do that for so long, and really, the population almost demands that there is increased spending against healthcare. So I think we're starting to see the benefit of that as well.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Terrific. Thanks guys.
Operator:
Your next question is from David Lewis of Morgan Stanley. Your line is open.
Scott S. Wang - Morgan Stanley & Co. LLC:
Hi, guys. This is actually Scott in for David. Just two quick questions from me. I guess, first for Liam or Tom. Looking at the organic growth guidance for rest of the year, it seems like you did basically a little bit above 4% in the first quarter. You did the 3.5% this quarter, to get to kind of the midpoint of your guidance, I kind of see the back half delivering organic growth something closer to 5%. And I was wondering if you can talk us through what gives you kind of the confidence that that will happen in the back half versus the front half. What are some of the key drivers of that acceleration?
Liam Kelly - Teleflex, Inc.:
All right, Scott. I'll start and if Tom wants to add to it and by all means. So, first of all, thanks for the question. I would like to point out that our constant currency revenue growth in the first half of the year was 14.4% first of all. Adjusted for VSI and billing days, our growth is actually 4.6%, which is an apples-to-apples comparison to our constant currency full-year revenue guidance of 4% to 5%. For the first six months of the year, we are right on plan and slightly above the midpoint of our constant currency revenue guidance at the half year stage. We feel good about the reminder of the year as China headwind becomes a tailwind and we feel even better about next year as VSI rose off our base growth and this would add approximately 1% to our organic growth moving forward. So, Scott, we feel in a really good place regarding our guidance.
Scott S. Wang - Morgan Stanley & Co. LLC:
That's really helpful. And the only other question I had was from our analysis, it seems like Vascular in North America did particularly well this quarter, and I was just wondering if you saw any benefits from disruption at one of your competitors, namely BARD, did you see any kind of benefit in taking market share or was it more just execution? Thank you.
Liam Kelly - Teleflex, Inc.:
All right. Thank you very much. Yeah, Vascular performed well, growing at 6.3% then when I adjust for billing days, you add about another 1.6% to that. So, we're really encouraged. We've continued to see strength in our PICC portfolio, Scott. Our PICC portfolio within North America was up over almost 30%, and we continue to put a focus on our antimicrobial and anti-thrombogenic PICC, because hospitals are very focused on thrombus and infections, and we're the only company that has the solution to the infection. So we feel very confident on that growth trajectory continuing for our Vascular business. And also EZ-IO, the Vidacare portfolio, continues to grow at the half year, it's still growing at 20%, and we see that very sustainable for the remainder of the year.
Scott S. Wang - Morgan Stanley & Co. LLC:
That's great. Thank you very much.
Operator:
Your next question comes from Matthew Mishan with KeyBanc Capital. Your line is open.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Hey. Good morning, and thanks for taking the questions. Hey, Tom, on the Vascular Solutions, your ability to put-off the high-yield financing, is that something you permanently put off or something which is you're just still evaluating your different options?
Thomas E. Powell - Teleflex, Inc.:
Well, as mentioned, we've taken a look at our sources and uses of cash that come in a little bit stronger on the cash flow than our initial expectations. We've been able to pay down our bank debt by $90 million, and we freed up additional capacity on the revolver. And so, as we look out for the rest of 2017, the high-yield is off the table relative to Vascular Solutions, and we expect not to need to put that high-yield financing in years following either. So we believe that we are able to meet our own needs for cash through internally generated sources at this point in time. So it's permanently off the table.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
And just following up on that, I think you said that Vascular Solutions would be accretive by about $0.50 by 2018. What do you think it would be accretive by 2018 without the high-yield financing?
Thomas E. Powell - Teleflex, Inc.:
Well, as we think about the impact for the second half of the year, you know I said it's about a $6 million benefit there, so it would roughly double that benefit on a full year basis and that would put you in the kind of $0.16 to $0.18 additional accretion.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Okay, great. And then on RePlas, is there an opportunity for early sales of that once you've begun the clinical trials? Is that something which you could potentially get sales for before it's over it, is there an opportunity for that?
Liam Kelly - Teleflex, Inc.:
Hey Matt, it's Liam here. The clinical trials are in order to get FDA approval, so we can't sell prior to FDA approval. So, this clinical trial, and they have advised we need to this one and one more. So we expect to commercialize around the midpoint of 2020, at this stage, that's our expectation, Matt.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
All right. Thank you.
Operator:
Your next question is from Mike Matson with Needham and Company. Your line is open.
Jake Elguicze - Teleflex, Inc.:
Hello?
Mike Matson - Needham & Co. LLC:
Okay. Can you guys hear me?
Liam Kelly - Teleflex, Inc.:
Yeah, there we go.
Mike Matson - Needham & Co. LLC:
Sorry, I had it on mute. So just with regard to the EPS guidance increase, you know it looks like you're increasing it by about the added benefit you're now expecting from smaller currency headwind, and yet you beat it by about $0.14 this quarter, as well. So now, some of that may have been from currency, but why not take the guidance up more, just given the degree of the beat? Was the Street just sort of modeling things wrong in terms of the quarterly sequencing of the EPS numbers?
Thomas E. Powell - Teleflex, Inc.:
Well, I think a key point is, we look at our year, we're managing to our internal projections. And so, we're never exactly aligned with how the Street is looking at things. As we look at ourselves through the first six months of the year, what we're seeing is, constant currency revenue is right on expectations, gross margin and operating margin are right on expectations, and the Vascular Solutions integration is proceeding as planned. And where we're seeing some upside is the interest expense, as I mentioned, and that's about $6 million in the back half of the year. We're seeing some benefit from FX as a result of the more favorable rates. And in the first quarter, we got a tax windfall. So as we think about it, those are the areas of upside that we're seeing right now. And as discussed in our prepared remarks, we now believe that we can accelerate some investment for the Vascular Solutions integration. So as we look at those three areas of upside, as well as the investment, we believe we're in position to flow through $0.20 increase in guidance between the first quarter and second quarter raises. Now certainly, if foreign exchange stays at the level we've seen in recent weeks, we could have additional benefit in the future, but right now, we feel as if we're tracking favorably on a couple of non-operating issues, and right on where we expected to be from an operating standpoint for the first six months.
Mike Matson - Needham & Co. LLC:
All right. Thanks. And then, can you just remind us with regard to the medical device tax, what you did with the savings there? And how big of an impact you'd expect if it were to be resumed in 2018?
Benson F. Smith - Teleflex, Inc.:
It was approximately $0.12 I think or $12 million, excuse me, and the majority of that went into additional R&D spending.
Mike Matson - Needham & Co. LLC:
And would you be able to pull that back out of R&D to offset the return, if it does come back?
Benson F. Smith - Teleflex, Inc.:
I think at this point it's a little too soon for us to make a prediction about how we might react to that. Certainly, some of these R&D programs are in the middle of their project life and not a good time necessarily to arbitrarily cancel them. So I think we'll just have to look at how we might adjust for that in 2018 against a broader array of things that are going on in our P&L.
Mike Matson - Needham & Co. LLC:
Okay, thanks. And just finally on RePlas. I mean, is there any chance we'll see any sort of interim data from the trials or is it just going to be – or do we have to wait until everything is done before you'd give us any sort of update there?
Liam Kelly - Teleflex, Inc.:
No, there are two trials. So the first trial will finish, is expected to finish in the summer of 2018 and we should have those results. And once we have those results, we will be sharing them with the investment community.
Mike Matson - Needham & Co. LLC:
All right, thanks a lot.
Operator:
Your next question is from Chris Cooley with Stephens. Your line is open.
Chris Cooley - Stephens, Inc.:
Thank you, good morning. I appreciate you taking the questions. Maybe just one quick one for me, for Tom. When you look at the stronger cash flow through the first half of the year, and the reduction that you've seen so far in gross leverage, just kind of curious what you're thinking about or how you're prioritizing uses of cash going forward? Do we see a greater focus on kind of the instant gratification of distributor to direct conversions or tuck-in M&A once you get down to kind of sub-three times gross leverage come back into the equation? Just help us frame that up. Thanks so much.
Thomas E. Powell - Teleflex, Inc.:
Sure. Well, as we looked at our cash flow projections, even following the Vascular Solutions acquisition, we always left ample room to continue our distributor to direct conversion strategy and, candidly, to continue to fund business development efforts whether they are late-stage technology or some smaller tuck-ins. Now, we are a company who looks at companies opportunistically, so if something were to come along that were of keen interest, we would certainly take a look at that. So from our perspective, we saw a very quick delevering given both earnings growth and cash flow generation following Vascular Solutions, and we don't expect that to hold us back from pursuing opportunities that appear attractive.
Chris Cooley - Stephens, Inc.:
Thank you.
Operator:
Your next question is from Dave Turkaly with JMP Securities. Your line is open.
David L. Turkaly - JMP Securities LLC:
Thanks. Just one clarification from Liam. The 4.6% organic growth that you talked about earlier on a question, is that the quarter or is that a year-to-date number?
Liam Kelly - Teleflex, Inc.:
That was for the half year.
David L. Turkaly - JMP Securities LLC:
Okay.
Thomas E. Powell - Teleflex, Inc.:
And, Dave, that's a constant currency number ex Vascular Solutions.
Liam Kelly - Teleflex, Inc.:
And adjusted for days, correct.
Thomas E. Powell - Teleflex, Inc.:
Yeah.
David L. Turkaly - JMP Securities LLC:
Great. And then, we've spoken to some surgeons of late on some of your newer products, specifically Percuvance and MiniLap, and I just wanted to get your thoughts on where those products stand today and it seems like there's a bunch of different surgeon group subspecialties that would benefit from them, but any color on where the sales base is now and where you think it's going maybe over the next 12 months or so?
Liam Kelly - Teleflex, Inc.:
Yeah, Dave. Overall, I think we are very happy with the continued enthusiasm we see for our percutaneous product offering from surgeons. We've had a number of analysts that have spoken to surgeons directly and published. We had a minor setback in quarter two when we initiated a voluntary recall on the Percuvance due to the product falling outside our tight tolerance specification. We identified the issue quickly during quarter two, and we're now back in the market with replacement product. During quarter two, we presented to 14 VAC committees and received 12 approvals. Our sales force is back out there driving the product with great enthusiasm and this recall will not materially impact our performance in 2017, as it was mitigated incredibly quickly by our quality teams. So again, very positive, the VAC hit rate continues in that 80% range, I think that's 86%, 12 out of 14. So again, quite enthusiastic for the product, continues to get traction, procedures that we're seeing it's being used on increasingly are bariatric and gynecological procedures.
David L. Turkaly - JMP Securities LLC:
Thanks a lot.
Operator:
Your next question is from Matt Taylor with Barclays. Your line is open.
Matthew Taylor - Barclays Capital, Inc.:
Hi. Good morning. Thanks for taking the question. You mentioned China a couple of times. I was just hoping you could give us an update on how that transition will look in the second half of the year with regards to growth and maybe just give us some operational thoughts now that you're kind of going direct there. What could that mean for your growth and profitability in China going forward?
Liam Kelly - Teleflex, Inc.:
Thanks, Matt. It's Liam here. I'll take this. So, what we see is in quarter three, so year-to-date, China has been a headwind of about 60 basis points. So that headwind would disappear in quarter three and it will become neutral or modestly accretive to our growth. And then, once you get into quarter four, we will see it contribute to our growth and you'll see that come through in core volume. Operationally, we are in a good place. We have recruited all the sales talent; they are out there creating demand within the marketplace. And as I said there to you in a recent review I had with the China team in our sales out metric, which is the most important metric, we are marginally ahead of our expectations. So, all-in-all, we feel really comfortable with where we are in the transition from that master distributor in China.
Matthew Taylor - Barclays Capital, Inc.:
Thanks. And I was wondering, if you could talk a little bit about the different products in the Vascular portfolio now that you've owned the company for a period here, which areas are doing maybe a little bit better than expected and are there any doing a little bit worse than you initially forecast?
Liam Kelly - Teleflex, Inc.:
So, the good news is that, GuideLiner continues to perform really, really well at the half year; that's growing about 17%. Turnpike is also doing really well at the half year; it's about 70%. The other micro-introducer kits is doing fairly well, that's up in the 18% region. No surprises, Matt, thankfully to report. The products are performing in line with expectations. We're getting double-digit growth in the quarter. It grew by 11.5%, and it's been growing in that range since we acquired it. So, double-digit growth continues. I'm really looking forward to when it rolls off our M&A part of our P&L into core organic growth, because it led approximately 1% to our overall growth in Teleflex.
Matthew Taylor - Barclays Capital, Inc.:
Great. Thanks a lot for the thoughts.
Operator:
Your next question is from Richard Newitter with Leerink Partners. Your line is open.
Ravi Misra - Leerink Partners LLC:
Hi. This is Ravi for Rich. Thank you for taking the questions. I just had one on the freeze-dried plasma product. Could you help us understand the competitive dynamic in the space? I don't believe there's anything out there aside from maybe some French suppliers of the product. And could you maybe give us some opinion on the -- any sort of patent protection you'll have there? And is there anything, given the importance of this study and usage by the U.S. military that could potentially accelerate approval of the product ahead of those 2020 timelines? Thank you.
Liam Kelly - Teleflex, Inc.:
Okay, Ravi. So, you are absolutely correct. There is one French company and one German company that do provide freeze-dried plasma. Both of those went through a local approval process in their countries, and neither are available for in the United States, neither have a 510(k) approval, and our understanding is that there are no clinical trials going on with either of those product categories. To our own potential of accelerating, it's really, Ravi, dependent on how quickly we can get the clinical trials done and get the results published to move on from Phase I trial to Phase II and accelerate that. Obviously, we're working closely with the FDA, because the military wants this product as soon as they can possibly get it, because it does have a serious impact on the troops in the battlefield. To your IP question, the IP isn't on the freeze-drying a product itself, but it's more in the delivery mechanism. Most products today are in glass jars, almost like if you remember M*A*S*H, those glass jars used to hang up in M*A*S*H, the television program. But ours is in a compressible bag, which is ideal for battlefield and also for emergency ambulance delivery of freeze-dried plasma to a patient. So the double valve on our bag is where the IP lies, and we have really strong IP around that.
Ravi Misra - Leerink Partners LLC:
Great. Thank you very much.
Operator:
And you have a follow-up from Larry Keusch with Raymond James. Your line is open.
Lawrence Keusch - Raymond James & Associates, Inc.:
Yeah, just a quick housekeeping. What's the assumption now for the remainder of the year for the euro? It had been I believe 1.04, and could you just maybe talk a little bit about the headwind that may be present from the peso strengthening?
Thomas E. Powell - Teleflex, Inc.:
Sure. So we updated our forecast projections in mid-June at the time the euro was trading around 1.11 to the dollar. We expected Q2 to end up around 1.10, and that's the rate that we put into our projections for the balance of year. So we've got the balance of the year at 1.10, you know as we look past couple of weeks, we've seen a dramatic weakening of the U.S. dollar relative to the euro. The euro's now trading at 1.18, so to the extent it were to stay at that level, we could expect additional translational benefits. As far as the strengthening dollar, that obviously impacts our ability to purchase – or excuse me peso, impacts our ability to purchase from Mexico. And as we look at all of the impacts, we have seen some benefit from the translational side offset on the transactional side. In fact, the transactional impact has been a little bit bigger than we typically see, largely due to some of the other currency moves around the world, including the peso.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay, terrific. Thanks, Tom.
Operator:
And I'm showing no further questions. I would like to turn the call back to Jake Elguicze for any further remarks.
Jake Elguicze - Teleflex, Inc.:
Thanks, operator, and thanks to everyone who joined us on the call today. This concludes the Teleflex Incorporated second quarter 2017 earnings conference call.
Operator:
Ladies and gentlemen, thank you for participating in today's conference. This concludes the program, and you may all disconnect. Everyone, have a great day.
Executives:
Jake Elguicze - Teleflex, Inc. Benson F. Smith - Teleflex, Inc. Liam Kelly - Teleflex, Inc. Thomas E. Powell - Teleflex, Inc.
Analysts:
Matthew Taylor - Barclays Capital, Inc. Lawrence Keusch - Raymond James & Associates, Inc. Scott S. Wang - Morgan Stanley & Co. LLC Anthony Petrone - Jefferies LLC Mike Matson - Needham & Co. LLC David L. Turkaly - JMP Securities LLC Rich S. Newitter - Leerink Partners LLC Matthew Mishan - KeyBanc Capital Markets, Inc.
Operator:
Good day, ladies and gentlemen, and welcome to the First Quarter 2017 Teleflex Incorporated Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this conference call is being recorded. I would now like to turn the conference over to Jake Elguicze, Treasurer and Vice President of Investor Relations. Sir, you may begin.
Jake Elguicze - Teleflex, Inc.:
Good morning, everyone, and welcome to the Teleflex, Incorporated first quarter 2017 earnings conference call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing 855-859-2056 or for international calls 404-537-3406, passcode, 12639722. Participating on today's call are Benson Smith, Chairman and Chief Executive Officer; Liam Kelly, President and Chief Operating Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Benson, Liam and Tom will provide prepared remarks and then we'll open up the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our press release today, as well as our filings with the SEC, including our Form 10-K, which can be accessed on our website. With that, I'd like to now turn the call over to Benson.
Benson F. Smith - Teleflex, Inc.:
Thank you, Jake, and good morning, everyone. To begin, I would like to start the call by saying that we are quite pleased with our Q1 results. Following a solid fourth quarter performance to end 2016, Teleflex is off to a strong start in 2017. During the first quarter, revenues grew by 14.8% on an as-reported basis and 16% on a constant currency basis. This includes the contribution from Vascular Solutions product lines, which added meaningfully during our partial quarter of ownership, accounting approximately 5% of our constant currency revenue growth, and delivering approximately $0.03 to our adjusted earnings per share. I'm happy to say that Vascular Solutions' revenue and adjusted earnings per share performance during the quarter was in line with our initial expectations and that integration activities are well underway and continue to be on track. Turning to our base business, during the quarter, top-line growth was broad-based and covered several of our operating segments. We continue to see stability within our end markets, good global utilization of many of our products and positive momentum in revenue generated from newly introduced products to the market. Additionally, the flu season in the fourth quarter of 2016 and the first quarter 2017 was more normalized and we do not currently expect the same distributor ordering pattern dynamics in 2017 that negatively impacted our business in 2016. Finally, during the first quarter, we continue to make progress on our distributor conversion within China. Turning to profitability, during the first quarter of 2017, we generated adjusted gross and operating margin growth of 110 basis points and 100 basis points, respectively. The margin performance in the quarter was modestly better than our internal expectation and gives us confidence in our ability to achieve our full year 2017 guidance targets. The additional operating leverage generated in Q1 translated into adjusted earnings per share of $1.80, which is an increase of 18.4% versus the first quarter of 2016. Given the good start to 2017, we are reaffirming both our full year as-reported and constant currency revenue growth ranges and slightly increasing our full year adjusted earnings per share guidance range. And while Tom will go through this in more detail during his prepared remarks, the decision to increase our full year adjusted earnings per share range is primarily due to moderate operational benefits that were achieved in Q1 as compared to internal expectations; the acquisition of Pyng Medical, which closed in April and was not in our original adjusted earnings per share estimates; and a larger than anticipated tax benefit that occurred in the first quarter associated with stock compensation tax benefit accounting change. In closing, Teleflex is on track to either meet or exceed the original 2017 financial targets that we provided the investment community a few months ago. And we continue to believe that 2017 will be yet another year, in which we can leverage our income statement through a combination of revenue and non-revenue-dependent actions, further expanding adjusted gross and operating margins and adjusted earnings per share. That completes my prepared remarks. I'd like to turn the call over to Liam.
Liam Kelly - Teleflex, Inc.:
Thank you, Benson, and good morning, everyone. For the consolidated company, first quarter 2017 constant currency revenues grew 16%. This includes positive sales volumes of existing products, which contributed 7.8%. These sales volumes were aided by five additional selling days during the first quarter. And if you were to normalize for results for the additional selling days, our constant currency revenue growth from core product volumes would have been approximately 1.8%. We estimate that the additional days added about 6% this quarter. The main reason the billing days had a larger impact in quarter one versus the fourth quarter of 2016 is the result of a smaller denominator. Quarter one revenues were lower than quarter four. Our decision to go direct within China resulted in our former massive distributor of vascular and cardiac goods to no longer purchase products. As we said in our last earnings call, we view these sales headwinds in China to be temporary in nature and not indicative of our longer-term growth potential in that country. And we anticipate a return to positive revenue growth during the second half of 2017. In fact, we've continued to make progress in adding to our direct sales presence in that area and believe that over the longer-term we will be able to improve margin, get closer to the end users of our products and gain better control of the sales channel. Turning to revenue growth coming from recently completed acquisitions. During the quarter, M&A contributed approximately 5.8% of constant currency revenue growth. Of this amount, Vascular Solutions added about 5.1%, while CarTika, an OEM business we acquired in September of last year, added about 70 basis points. And while we did not own Vascular Solutions for the entire first quarter, one of the reasons we acquired the company was because of their ability to consistently generate double-digit revenue growth. And they did not disappoint in quarter one, growing approximately 13% in the first quarter of 2017 as compared to the prior year period. Growth in Vascular Solutions was primarily due to increased sales of our Turnpike, GuideLiner, and micro-introducer kit products. Moving to new products, the positive revenue trend we have seen for the past several quarters once again continued in quarter one, this time contributing approximately 1.8% of constant currency growth. This represents the highest constant currency revenue growth contribution stemming from new products yet and positions us well for 2017 as many products, which were launched during 2016, continue to gain traction. From a geographic perspective, new product revenue growth was once again led by our North American businesses. But from a product line standpoint, new product sales were particularly strong within our surgical, vascular and anesthesia product lines. Surgical new product sales were driven by increased utilization of products used in robotic procedures and the further penetration of our EFx offering. Vascular new product revenues increases are attributable to further penetration of our infection control orientasers (08:47), antimicrobial and anti-thrombogenic VPS PICCs. While in anesthesia, the growth is primarily due to increased sales of our LMA Unique product, Silicone, and the Rusch TruLite Laryngoscope. And, finally, during quarter one, we saw continued improvements in the average selling prices of our products, which drove revenue higher by another 60 basis points. This was primarily due to increases in our Vascular, Surgical and Asia reporting segments. In summary, if you were to compare the first quarter components of constant currency revenue growth, excluding the shipping day impact and Vascular Solutions to our full year 4% to 5% guidance range, you will see that they compare favorably. Excluding the impact of the additional shipping days, core product volumes grew 1.8% and was within our full year guidance range. Pricing grew 0.6% and was also within our full year guidance range, while new products and CarTika added 1.8% and 0.7%, respectively, and were above our full year guidance range. Next, I would like to provide some additional color surrounding our segment and product related constant currency revenue growth drivers during the first quarter. Vascular North America first quarter revenue increased 14.8% to $93.8 million. The increase in Vascular revenue was largely due to higher sales volumes of Vidacare EZ-IO and OnControl devices, increased sales of infection control called CVCs and PICCs as well as from the impact of the increase in the number of selling days within the quarter. Moving to Anesthesia North America, first quarter revenue was $48.2 million, up 4.7% versus the prior year period. Growth in this segment occurred within Vidacare EZ-IO, atomization and air re-management (10:52) devices and was the result of additional selling days in the quarter. Turning to our Surgical North America business, its revenue increased 17.7% to $46 million. The increase within Surgical is primarily attributable to higher sales volume of access ports, ligation clips and chest drainage products. Growth in this business was also aided by the additional selling days in the quarter. Shifting to our overseas operations, EMEA revenues continued their positive trajectory, growing 10.9% on a constant currency basis to $130.7 million. The improvement in Europe revenues was largely the result of the increased number of selling days. However, if you were to normalize their results for the selling day impact, we estimate that EMEA revenues still grew approximately 3%. Moving to Asia, our first quarter revenue decreased 0.4% to $49 million. The decrease here is primarily due to sales volumes being negatively impacted by our distributor to direct sales conversion in China. As I mentioned earlier, we currently expect a return to positive revenue growth within Asia during the second half of 2017. Turning to OEM, during the first quarter, revenue increased 28.4% to $43.3 million and was primarily due to higher sales of catheter and performance fiber products as well as the CarTika acquisition. And, lastly, first quarter revenue for the business within our All Other category was up 45%, totaling $76.9 million. Growth here is primarily attributable to the acquisition of Vascular Solutions as well as sales of additional cardiac intra-aortic balloon products. I would also like to point out that Vidacare product sales continue at a very good pace, growing globally 23% on a constant currency basis in quarter one 2017 as compared to the prior year period. And as has been our customary practice, I would like to next briefly update you on the status of GPO and IDN awards as well as some recently received regulatory approvals and product launches. Adding to the success we realized in 2016, during the first quarter of 2017, we won an additional 14 new GPO and IDN agreements and extended 16 others. Of the agreements won and extended in quarter one, 16 were sole-source in nature and cover a wide variety of clinical areas, including our laryngeal masks, ligation clips, midline catheters, laryngoscopes, CVC catheters, humidification devices, PICCs and arterial product offerings. I point this out because it further supports our ability to generate positive broad-based revenue growth within clinical practice areas that are not already susceptible to extreme cost pressures or elective procedure downturns. Moving next to some recent product introductions and regulatory approvals, which we've received. I mentioned earlier that one of the reasons we acquired Vascular Solutions was because of their ability to consistently generate double-digit revenue growth rates. Well, another reason we acquired them was their robust product pipeline. In fact, the next three products I'm going to talk to you about are Vascular Solutions product, while the fourth is a new cardiac balloon pump that we are bringing to market. Starting with the Spectre Guidewire. We recently received 510(k) clearance and began U.S. commercial launch of this product which is designed for premium performance in coronary and peripheral interventions and has enhanced tractability and torque control. The device is a guidewire available in multiple lengths and has both a distal hydrophilic coating and a proximal PTFE coating. Approximately 70% of the guidewire used in percutaneous coronary interventions or PCIs are considered workhorse guidewires and are used to deliver catheters, balloons, stents and other diagnostic and therapeutic devices. As such, it is our belief that the Spectre Guidewire will be applicable to the majority of PCIs. Turning next to Twin-Pass Torque Dual Access Catheter. This product also received FDA 510(k) clearance and was launched both domestically and internationally. This catheter contains both a rapid-exchange lumen and an over-the-wire lumen. The beauty of this product is that, with the guidewire deployed through the rapid-exchange lumen, the over-the-wire lumen can be used for guidewire exchange, subsequent delivery of a second guidewire or fluid injection to a desired distilled vessel segment. It is a product that is designed for procedures that call for the delivery of two interventional guidewires from a single catheter in clinical situations where catheter delivery and control are paramount. Turning to the TrapLiner. This is the third new Vascular Solutions product that received FDA 510(k) clearance during the quarter. This product's design is similar in nature to Vascular Solutions popular GuideLiner Extension Catheter, but it has the added feature of an integrated balloon for trapping a standard guidewire. It can be used as an alternative method to the trapping technique that requires the use of a PTCA balloon to exchange an existing over-the-wire catheter, while maintaining guidewire position and is most commonly used in complex interventional procedures. Lastly, from a new product standpoint, I would like to call your attention to the Arrow AC3 Intra-Aortic Balloon Pump or IABP. This device helps a weakened heart pump blood and can deliver IABP therapy to a broad range of patients, even those not previously considered candidates for IABP therapy. Clinicians can use this pump on patients with severe arrhythmias or with heart rates as high as 200 beats per minute. It has a third-generation AutoPilot Mode, which uses proprietary algorithms, which has addressed key clinical challenges and simplifies the delivery of IABP therapy. Each of the new products I spoke about this morning continued to advance our product offerings within the interventional space. And we're quite enthusiastic about their potential and view them as nice revenue growth engines of the future. Moving next to an acquisition update. I'm pleased to report that we continue to put capital to work, completing the acquisition of Pyng Medical in April. Pyng's product portfolio includes a variety of innovative life-saving tools, including intraosseous infusion, pelvic stabilization, hemorrhage controls and emergency airway management devices. This accretive, all-cash transaction further enhances Teleflex's product offering to the military and civilian trauma markets and builds upon our previously completed acquisitions in the emergency medicine field, most notably LMA and Vidacare. And as Benson stated in his prepared remarks, this acquisition was not included when we provided our initial 2017 financial outlook. And it is expected to contribute in a very modest, positive way to our revenue and adjusted earnings per share during the remainder of 2017. We welcome the Pyng employees to the Teleflex family and look forward to their contributions in the future. Lastly, before I turn the call over to Tom, I would like to provide you with an update on the various restructuring efforts underway at the company. As most of you are aware, Teleflex is committed to driving non-revenue-dependent leverage throughout the income statement. And, as such, during the first quarter, we announced two new restructuring programs. The first program relates to the integrating of Vascular Solutions operations into our operations. We initiated this program in quarter one and expected to be substantially completed by the end of the second quarter 2018. We estimate that we will incur pre-tax restructuring charges of between $6 million and $7.5 million related to termination benefits, employee relocation and outplacement costs. Additionally we expect to incur between $2.5 million to $3 million of restructuring related charges consisting primarily of retention bonuses offered to certain employees. All of the aforementioned costs will result in future cash outlays and will be added back when we calculate adjusted earnings per share. We began realizing synergies associated with this program during the first quarter of 2017 and expect to achieve annualized pre-tax synergies of between $20 million to $25 million once the program is fully implemented. I would like to point out that we continue to believe that we can achieve annual pre-tax synergies of between $40 million to $45 million related to Vascular Solutions by the year 2019. The second restructuring program that we committed to during the quarter relates to the centralization of certain administrative functions within Europe. This program will commence in the second quarter of 2017 and is expected to be substantially completed by the end of 2018. We estimate that we will record pre-tax restructuring charges of between $7.1 million to $8.5 million, almost all of which constitute termination benefits and all of which will result in future cash outlays. Similar to my comments regarding the costs incurred as a result of the Vascular Solutions restructuring program, all of the aforementioned costs associated with the European restructuring plans will be added back when we calculate adjusted earnings per share. With the European program, we expect to achieve annualized pre-tax savings of between $2.7 million and $3.3 million once the program is fully implemented. And we expect to begin realizing savings during the first quarter of 2018. In addition to the restructuring programs that I just mentioned that we initiated during 2017, we have other ongoing restructuring programs related to the consolidation of our manufacturing operations, as well as programs designed to improve operating efficiencies and reduce costs. We've been receiving feedback from the investment community that they would like us to summarize all of these restructuring programs in one place and we're attempting to do that here. It is very important to understand that this chart simply represents the restructuring initiatives that have been approved and that are currently underway at the company and their respective costs and synergies. This does not include additional savings that we anticipate to generate that come in the form of annual cost improvement programs, material substitution initiatives, improved pricing or potential future restructuring programs. These expected savings would be additive to the amount shown here and it is our intention at our Analyst Day later this year to provide a comprehensive summary of all our expected savings over a forward-looking multi-year period. That being said, our announced restructuring programs indicate that we expect to incur between $104 million to $125 million of total charges by the time that these programs are complete and that as of December 31, 2016, we incurred approximately $63 million of those costs. Turning to anticipated savings, we expect that we will generate between $80 million to $96 million of annualized pre-tax synergies by the time these programs are complete. And that through December 31, 2016, we achieved $31 million of these annualized pre-tax savings. This leaves us with between $49 million and $65 million of additional annual pre-tax synergies yet to be realized. And it is our belief that we will realize substantially all of these estimated annual pre-tax savings and synergies by December 31, 2019. That takes me to the end of my prepared remarks. At this time, I would like to turn the call over to Tom for him to review our financial results for the first quarter and provide our updated guidance for 2017. Tom?
Thomas E. Powell - Teleflex, Inc.:
Thanks, Liam, and good morning, everyone. Given the previous discussion of the company's revenue growth drivers, I'll begin my prepared remarks with gross profit. But before I do, I'd like to reinforce that the company is off to a good start in 2017. On a constant currency basis, revenues were slightly better than our internal Q1 estimates due to broad-based strength across most of our strategic business units, while currency headwinds were more moderate than we had initially expected. We realized expansion of both gross and operating margins versus prior year levels. Financial leverage was good, with 21.1% adjusted net income growth being generated from 14.8% as-reported revenue growth. Cash flow from operations generation was also strong and increased 36% versus the prior year period. Given the performance in Q1 and our outlook for the remainder of the year, we are raising our adjusted earnings per share guidance by $0.05 on the bottom end and $0.08 on the top end of the range. Turning now to first quarter results. For the quarter, adjusted gross profit was $267.1 million versus $227.8 million in the prior year quarter. Adjusted gross margin was 54.7%, representing a 90 basis point sequential increase from the fourth quarter of 2016 or 110 basis point increase when compared to the prior year quarter. A 110 basis point increase versus prior year was sourced as follows
Operator:
Thank you. Our first question comes from Matt Taylor from Barclays. Your line is now open.
Matthew Taylor - Barclays Capital, Inc.:
Hi. Good morning. Thanks for taking the questions.
Benson F. Smith - Teleflex, Inc.:
Good morning, Matt.
Liam Kelly - Teleflex, Inc.:
Hi, Matt.
Matthew Taylor - Barclays Capital, Inc.:
So, I guess, the first question I had was, can you help us understand how you're thinking about the earnings guidance range? Whether you – coming ahead in Q1 helped a little bit by tax here. These are going well to start the year. Surprised to see you not raise a little bit more. What are you thinking about in terms of different risks throughout the year? You're getting a little bit of a lift from FX. Just want to understand that a little bit better.
Thomas E. Powell - Teleflex, Inc.:
Sure. Why don't I take that? So as we look at the first quarter, we did have a benefit from the windfall tax of about $0.07. We also had a couple pennies as a result of the over performance in revenue that flowed through the bottom-line. So we did see a nice start to the year on both revenue and EPS. As we thought about the guidance, we took a look at FX. And in the quarter, while we had some translational benefits, they did not flow – the revenue upside didn't flow through the bottom-line, largely because of an offsetting transactional downside. So we didn't see the FX benefit flow through in any EPS generation. So as we think about the balance of the year, we want to work through the next couple of quarters and make certain that we've got funding available for any investments that we need and make sure that we've got sufficient resources for the integration of Vascular Solutions and thought that the upside from taxes and the slight benefit from operations would flow through as additional upside to our guidance. As we get further into the year, we'll take a look at how currency is trending. Right now, since the French elections, we saw a nice move with the euro strengthening that will tend to help us. And should that continue, we could see some favorability there. We also look to see how our operations plays out before we would consider a higher raise on our EPS guidance.
Matthew Taylor - Barclays Capital, Inc.:
Okay. Thanks for that. And I thought it was encouraging to see the pickup in the contribution from new products. So I was hoping you could just give us a point or two on what really drove that. And maybe touch on the contributions that you're expecting from these new acquisitions.
Liam Kelly - Teleflex, Inc.:
Okay. So, Matt, it's Liam here. I'll take that. So with regards to new products, it was pretty broad-based. And we're encouraged by that, quite frankly. We did see a nice pickup in our VPS PICC offerings with the preloaded PICC that we had obviously launched late last year. And, of course, the ongoing focus of our PICC customers on the infection prevention and thrombus prevention is critically important to us because they've moved away – they are starting to move away from – and they have to report infections now on PICC. So, therefore, they're acutely aware that a coated PICC is saving the hospital funding. The other areas that we saw pickup was in the surgical group in our EFx. Within our anesthesia group and the LMA product family, in particular, on the LMA Unique with Silicone. Percuvance continues to ramp during the year. It isn't a significant contributor yet, but it will ramp during the year. And also, within our respiratory group on some of the humidification products. So, it was pretty broad-based, Matt, and that's very encouraging for us because across all our business units we're seeing a pickup.
Matthew Taylor - Barclays Capital, Inc.:
Okay. And then on the acquisition, can you talk about those?
Liam Kelly - Teleflex, Inc.:
Yes. So Pyng was the acquisition that we announced and it's going to have a modest revenue contribution. We expect that Pyng will contribute about 20 basis points thereabouts to our top-line, $3.9 million in revenue. Obviously, CarTika contributed 70 basis points within the quarter. Just remember, Matt, that we closed CarTika in September of last year. So you'll see a stronger contribution Q1, Q2 and then it will trail off Q3 and Q4. So we're still comfortable in our guidance for previously completed acquisitions.
Matthew Taylor - Barclays Capital, Inc.:
Great. Thank you for that.
Operator:
Thank you. And our next question comes from Larry Keusch from Raymond James. Your line is now open.
Lawrence Keusch - Raymond James & Associates, Inc.:
Thanks. Good morning, everyone.
Liam Kelly - Teleflex, Inc.:
Good morning, Larry.
Benson F. Smith - Teleflex, Inc.:
Hi, Larry.
Lawrence Keusch - Raymond James & Associates, Inc.:
Hi. Liam, you obviously mentioned the Vidacare growth in the quarter, which I think you said was 23%, very impressive. Could you just walk us through where you're seeing the growth, both in applications and perhaps geographies?
Liam Kelly - Teleflex, Inc.:
Yeah. So we continue to see solid growth within the EZ-IO and OnControl, Larry, just to give you basis points. The EZ-IO grew at over 20% globally and the OnControl grew above 35% globally. So we're very encouraged by that. Again, Larry, it was pretty broad-based. We had a strong European performance. We closed the last ambulance service within the UK, which obviously helped. And we continue to expand within Europe. On the domestic side, we continue to see hospital adoption of the EZ-IO as an emergency device for vascular access. And, clearly, the new sepsis guidelines are also helping us, Larry, where it is indicated now for use for sepsis patients. And that's obviously helping clinicians make that good decision to use an EZ-IO in the acute environment for sepsis patients. So, again, Larry, pretty broad-based, very solid in Europe and continued solid growth in domestic market.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Perfect. And then two other ones. Maybe you've owned Vascular now for, I guess, just under three months. So any observations from you guys relative to what you're seeing there? What may be a little bit better? What may need a little bit work? And then just quickly, for Tom, are you maintaining the $1.04 assumption for the euro? Or have you changed that at this point?
Liam Kelly - Teleflex, Inc.:
Okay. Well, I'll cover the Vascular Solutions piece first. So, Larry, we're positive on the integration of Vascular Solutions. We have now consolidated the sales organizations. We saw very robust growth in quarter one with Vascular Solutions, 13% growth over prior year. And as I said during my prepared remarks, that's one of the reasons we bought this company, for that consolidated growth. They're hitting their timelines on new products. So we had three new products from Vascular Solutions launched in the quarter. That's very encouraging. I'm glad to report, Larry, no surprises as of yet with the Vascular Solutions integration. And we continue to monitor it very, very closely, but very encouraged so far.
Thomas E. Powell - Teleflex, Inc.:
And then with regard to the foreign exchange, so just by way of background. When we locked in rates for our plan in early January, the euro was trading at $1.04 and that's the rate we selected. By the time we gave guidance, I think, it's a little over $1.05, at the end of February. And then following the French elections, it's risen up now to $1.09. So we see a lot of movement in the rates. The way we're thinking about it is, right now, we have not changed our assumption in our projections to move it each time we get a different change in the spot. I think we just – it would be a little bit hectic for us in trying to communicate that to everyone else. So we've left it to steady at $1.04. Should the rates stay where they are right now, we would expect to see some benefit on revenue as well as earnings. But as we saw in the first quarter, there can be offsets. So we had a translational benefit largely from the euro in Q1. So we saw about a $5 million pickup in revenue. However, we didn't see any EPS benefit because there was a transactional offset that offset the translational EPS benefits. So, right now, we're keeping our projections at that $1.04 rate. We recognize rates can move very quickly in both directions and just haven't updated based on today's rates.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Terrific. Totally understand. Thank you very much.
Operator:
Thank you. And our next question comes from David Lewis from Morgan Stanley. Your line is now open.
Scott S. Wang - Morgan Stanley & Co. LLC:
Hi, guys. This is actually Scott Wang filling in for David. I guess a couple quick one for me. Tom, just looking at organic growth, organic growth by our math kind of slowed this quarter on a comp adjusted basis and you were kind of facing the easiest comp of the year. Can you help us think through kind of the underlying drivers 4Q to 1Q on organic growth and what gives you confidence that growth can accelerate in the back half?
Liam Kelly - Teleflex, Inc.:
Okay. Scott, I might take that – it's Liam here – if you don't mind. So if you look back on a year-over-year basis, so our growth last year was 1.1%, although there were some billing days. If you normalize for billing days, it was about 3.3%. If you exclude any previously included M&As, the growth in this quarter was 4.2%. So we've actually shown that Q1 last year over Q1 this year actually nice progression. In relation to our guidance, our guidance is 4% to 5%. And it did include previously included M&As. And if you take that metric, in the 4% to 5% range, we're actually at 4.9%, at the top-end of that range. So, Scott, we're quite encouraged by the first quarter performance on the revenue line. What lets us believe that it will continue towards the latter half of the year, as we said in our prepared remarks, we had a dealer to direct in China. So therefore, that impacted our Q1 revenues in the region of about $2.5 million. So as we get – and that will continue through Q2, but then once we get into Q3 and Q4, that distributor will have burnt off their inventory and we will be dealing directly with those customers and shipping products. That's way we expect to see somewhat of a pickup in the H2 from core volume.
Thomas E. Powell - Teleflex, Inc.:
Yeah. So that distributor direct conversion is accountable for about 50 basis points to 60 basis points of revenue in the first quarter. If you add that to the $180 million of volume, that puts you, call it, $230 million, which compares favorably to last year's average which was just over $200 million. So, we actually, first quarter, once you adjust for that, is a slight tick up, but to your point the comp wasn't that difficult, so.
Scott S. Wang - Morgan Stanley & Co. LLC:
Got it. Thanks, guys. And then one more for me. Surgical performance improved quite substantially and I was wondering if you can share kind of Percuvance feedback from SAGES and what your updated expectations are for the impacts from that on growth over the next kind of two years? Thank you.
Liam Kelly - Teleflex, Inc.:
So SAGES was a very positive meeting for us, as it always is. The update on Percuvance is within the quarter. We went through 11 new VACCs in the quarter, three were rejected, eight have resulted in purchases. So we continue to see the adoption. It continues to be surgeon by surgeon, Scott. But we're still encouraged by the performance of the product, and we haven't changed our estimations in line with that. As we said, next year, it will be – percutaneous solutions will be 1% of our revenue. And then as you get into 2019, it will contribute 1% of our growth, and we're consistent with that.
Scott S. Wang - Morgan Stanley & Co. LLC:
Very helpful. Thank you, again.
Operator:
Thank you. And our next question comes from Anthony Petrone from Jefferies. Your line is now open.
Anthony Petrone - Jefferies LLC:
Thanks and good morning.
Liam Kelly - Teleflex, Inc.:
Good morning.
Benson F. Smith - Teleflex, Inc.:
Good morning.
Anthony Petrone - Jefferies LLC:
Maybe just go back again to the reconciliation on top-line guidance again. Just as we move through the second through fourth quarters here, just given the beat in the first quarter, earlier than expected to close on Vascular, new product seem to be doing well. There will be something more coming later this year. And then you had some small tuck-ins. I'm just kind of curious the why not a raise on the top-line guidance as well. And then I'll have two follow-up questions. Thanks.
Liam Kelly - Teleflex, Inc.:
Okay, Anthony. I'll take the revenue one. So we had Vascular Solutions closed when we gave guidance. So we had the timing of Vascular Solutions already built in to our guidance range of 8.5% to 9%. If you look at our guidance, we had volume 1.8% to 2.4%, quarter one was 1.8%, new products 1.4% to 1.6%. We were at 1.8%, so we were above the higher end of the guidance range. Pricing to 50 to 60 bps, we were at 60 bps. And previously included M&A, 30 to 40, and we're at 70 bps. So we're very encouraged by the first quarter. But don't forget that the previously included M&As, as I said to Matt in my previous comments, that was closed in September. So you would expect a good pick up in the first two quarters and then a little bit in quarter three, but it won't be available in quarter four. We are very encouraged by our performance in Q1. And, as Tom said earlier, we just are being a little bit prudent. We want to see another couple of quarters and run our business and be a little bit prudent with regard to any raise we might want to make in the future.
Anthony Petrone - Jefferies LLC:
Make sense. Maybe the follow-up will be on Vascular Solutions. Just in the synergy target, just how does the distributed-direct conversions play into that, if at all? And what is sort of baked in to the bottom-line this year for distributed-direct to direct conversions for Vascular Solutions specifically? And then I'll have one question about M&A.
Liam Kelly - Teleflex, Inc.:
Yeah. So when we gave the guidance of the $40 million to $45 million of synergies with Vascular Solutions, what we said was in the first year, this year, what you would see is that mostly coming from OpEx synergies. Then next year, 2018, you would see the dealer-to-direct conversions, I think, that would be appropriate. And then following years, it would mostly come from operational efficiencies. So we have no go-direct built into our plan for 2017 and none executed to-date.
Anthony Petrone - Jefferies LLC:
Excellent. And then last one from me would be just the largest deal announced a couple of weeks ago, Becton for Bard. Bard is a big competitor. Maybe just some thoughts around that transaction. On the positive end, is there a potential for gains? Should we see some dis-synergies on the headwind? And is there a risk to the combination of these two businesses should that deal close? Thanks.
Benson F. Smith - Teleflex, Inc.:
So this is Benson, Anthony. So actually, I think, the overlap between us and Bard is significantly exaggerated. Our principal competitive product lines with them happen to be in the PICC area. We compete with them some in the hemodialysis catheter area, but we continue to see really good growth in our PICC line. In the U.S., it's largely driven by the antimicrobial and antithrombogenic coating and by the positioning systems we have. We don't expect that to change at all as a result of BD owning Bard. I think that there's some reason to believe that there could be some disruption in the marketplace overall. But, again, our overlapping product lines with Bard are actually minimal. So we don't see it affecting us negatively at all. We do think that Bard was one of the companies that occasionally showed up competing for product lines that we're interested in on the acquisition front. We think that those are way too small now for BD to give much consideration to. So kind of eliminates, we think, a competitor in the acquisition space that we operate in.
Liam Kelly - Teleflex, Inc.:
And, Anthony, I'd just add to that. Just in the quarter we just closed, we saw our PICC sales growing at about the 25% range. So we're continuing to be really encouraged by the progress that we make in that one area that we compete with Bard and actually taking share. And that was back to the earlier comment that I made that hospitals are now really focused on infection and thrombus prevention, and we are the only company with a coated catheter that helps to prevent both.
Anthony Petrone - Jefferies LLC:
Thank you.
Operator:
Thank you. And our next question comes from Mike Matson from Needham & Company. Your line is now open.
Mike Matson - Needham & Co. LLC:
Good morning. Thanks for taking my questions.
Benson F. Smith - Teleflex, Inc.:
Good morning. Sure.
Liam Kelly - Teleflex, Inc.:
Good morning, Mike.
Mike Matson - Needham & Co. LLC:
Tom, I was just wondering if you could maybe – do you have some idea of how much the extra selling days contributed operating leverage in the quarter?
Thomas E. Powell - Teleflex, Inc.:
So in terms of the selling days, we estimate it was right around 6 points of revenue growth. And then in terms of GP, it's a little more difficult to fully estimate down to the bottom-line, but in terms of GP, around $15 million in the quarter. And then you could assume that we'd get somewhere around $8 million to $9 million on the bottom-line.
Mike Matson - Needham & Co. LLC:
Okay. And then the 13% growth at Vascular Solutions. Was there – did they benefit from the extra selling days or just given that it was only a partial quarter, I guess, they wouldn't have?
Liam Kelly - Teleflex, Inc.:
This is Liam here. No. The type of business they're in, they don't actually have any benefit to the billing days. So that is just a direct comparison year-over-year.
Mike Matson - Needham & Co. LLC:
Okay. All right. And then, finally, the 60 basis points of pricing, I think, you mentioned that some of that had come from the direct – the transition to direct distribution in China. So can you tell us how much of that was from that move? And then going forward, what does that impact look like? Is it going to be similar?
Liam Kelly - Teleflex, Inc.:
So most of it came from our core business. So the majority of that pricing came from vascular, surgical and cardiac in North America. The contributions from Asia were through the distributor model, not coming really from the distributor to direct, incredibly modest. So I wouldn't point too much to that coming through yet, Mike. You're going to see that in Q3 and Q4. So that's where we'll be talking about the contribution on pricing, in Q3 and Q4, from that distributor to direct.
Mike Matson - Needham & Co. LLC:
Okay. Got it. That's all I have Thank you.
Operator:
Thank you. And our next question comes from Dave Turkaly from JMP Securities. Your line is now open.
David L. Turkaly - JMP Securities LLC:
Great. Thanks. I was wondering as we sort of realize that this quarter was – had a big impact from the days, if we look at your segments, is there anything new that you're seeing in terms of the growth profile? I was wondering if there might be any chance realizing that Other is going to have Vascular Solutions? But your Other categories, is there a way to quantify or put a handle around sort of what you expect the growth to look like or at least maybe rank them in order in terms of how you think you're going to get to that top-line growth profile for 2017?
Liam Kelly - Teleflex, Inc.:
So you're talking specifically, David, about the Other category?
David L. Turkaly - JMP Securities LLC:
Actually, Other. I mean Other is going to have Vascular in it but like I mean, Vascular Solutions. So if we look at Vascular North America, Anesthesia North America, Surgical Europe, obviously, EMEA with the big quarter, I was wondering if there's a way you could sort of put a, I don't know, range around so what you're anticipating any of those to do or maybe even just rank them sort of in order of what you think will grow the fastest?
Liam Kelly - Teleflex, Inc.:
So, normally, David, what we expect is we expect our Vascular portfolio to grow pretty aggressive – to grow in that high-single-digits. We expect Cardiac division to grow in that high-single-digits. And then we would expect Surgical and Anesthesia to grow in the mid-single, perhaps into this – going into the higher single. And then for EMEA, we would expect those in the low single-digits growth rate on an annualized basis. And Asia, once we realize the go-direct, we'd again expect that to be in the high singles.
Thomas E. Powell - Teleflex, Inc.:
Yeah. I would add to that, David. I think our overview of the quarter is on a broad base and a broad geography things were more robust than what we had thought. It's a continuing positive trend. Some of it comes from, I think – certainly no slowdown in utilization and some of it comes from just share gains. So I think we left the end of first quarter quite favorable about the underlying trends, again, almost throughout our business portfolio and throughout our geographies.
David L. Turkaly - JMP Securities LLC:
Thanks. That's helpful. And then as we look at the model, Vascular Solutions being in Other, you mentioned a bunch of new products on the call. I think three from them. Is it your intent to kind of include those as – show them as we move forward in that Other category with Vascular sales and not as part of sort of your new product growth, the 1.8% you reported this quarter?
Thomas E. Powell - Teleflex, Inc.:
Yeah. So, Dave, I think, the intention is to report Vascular Solutions contribution this year and then any and all revenue associated with Vascular Solutions contribution this year in the All Other category. And then as we move forward, the different growth drivers beginning next year, if Vascular Solutions starts to have new products that come to market, we will then add any revenue growth into those buckets of new products or price or what have you.
Liam Kelly - Teleflex, Inc.:
And just to clarify, in the 1.8%, that from contribution to new products, there's no Vascular Solutions in that. That's all core Teleflex growth accelerating off the back of last year.
David L. Turkaly - JMP Securities LLC:
That's very helpful. Thanks a lot.
Operator:
Thank you. And your next question comes from Richard Newitter from Leerink. Your line is now open.
Rich S. Newitter - Leerink Partners LLC:
Hi. Thanks for taking the questions. Benson, just a comment that you made earlier, answering someone's question on the evolving kind of consolidation landscape. With Becton, it was an interesting kind of way to view a Becton taking a prospective competitor or someone who could compete against buying assets against you. I guess what's your approach to M&A for the next year, year-and-a-half? You're digesting Vascular. You don't do large deals, really, through intervals greater than – fewer than kind of one to two years. Just maybe give us a sense as to what we could expect on capital deployment towards M&A?
Benson F. Smith - Teleflex, Inc.:
So, I think our viewpoint is that we're going to de-lever from this acquisition relatively quickly given that perspective. We have certainly not slowed down our appraisal and evaluation of opportunities that are out there. And I think it's going to be more driven by particular opportunities more so than anything else.
Rich S. Newitter - Leerink Partners LLC:
Okay. Got it. And then just on China and emerging markets, given the scenario that you're kind of investing in a little bit more. Can you give us a sense, first of all, what the percentage of sales is today? Where do you kind of see this percentage going longer-term over the next two, three years? And should we think that this is going to be a double-digit grower like it had been for Bard – and Bard's been having a lot of success with their PICC adoption in that category. I was wondering kind of if you think you'll be able to complete as effectively with them now combined with Bard by a Becton who has an even stronger presence in China? Thanks.
Liam Kelly - Teleflex, Inc.:
So China, for us, is about a – last year it was about an $81 million business and it grew at about 7% on the entire year. Obviously, part of our growth rate was – part of our go-direct strategy was to accelerate our growth rates. What we've seen is the business where we didn't have a master distributor, the business we control with ourselves, mainly surgical, LMA and anesthesia. Our growth rates at sales out were much higher. If you add back the impact of China into the Chinese growth rate, we grew there in the 3.5%, 4% range in this quarter and we do see that accelerating into the latter half of the year. So we do expect China to be in that high-single, low-double-digit range for us on an ongoing basis.
Rich S. Newitter - Leerink Partners LLC:
Okay. That's helpful. Thank you.
Operator:
Thank you. And our next question comes from Matthew Mishan from KeyBanc. Your line is now open.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Hey. Good morning. Could you just give us an update on how you're looking at the long-term financing for Vascular Solutions and kind of what's implied still in the guidance?
Thomas E. Powell - Teleflex, Inc.:
Sure. As we communicated at the last earnings call, our approach and thinking about that was to put into our financial assumptions the assumption that we would look for more permanent long-term financing towards the midpoint of this year. Now with that being said, there are some developments ongoing in Washington with regard to tax reform, the potential for repatriation and we're watching that closely. And should an ability to repatriate come up and that change our plans for the proposed high-yields or other financing, we'd certainly let you know at that point in time. But, right now, we have not made a definitive decision to postpone that. And, as you know, we've put that into our guidance as a mid-year financing.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Do you need to see definitive progress on tax reform over the next three months for you to postpone doing that financing? Or is it – like, what would you need to see to postpone it?
Thomas E. Powell - Teleflex, Inc.:
Well, what we're really waiting for trying to identify is an opportunity to emerge to allow us to bring back cash. We've got quite a bit of cash sitting overseas. And if events were promising or look very promising, then we would continue to postpone that financing until something became definitive one way or another. Right now, it just isn't enough information to make that definitive one way or another decision, but we'll continue to monitor. And if it is looking promising, we wouldn't put in that high-yield or other long-term financing until a definitive outcome was determined.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Okay. Got it. And then moving on, I know this is like a longer-term product for Vascular Solutions, but can you give us an update on where RePlas is at, the progression to come into clinical trial is as expected?
Liam Kelly - Teleflex, Inc.:
Yes. It's Liam here. So we have just initiated the first clinical trial and that is to determine the efficacy. We have a high degree of optimism that that will be positive, simply because this procedure is available not in the way that we do it, but it is available in other parts of the world in a glass containment bottle. So we have a high level – high degree of confidence that this would be successful, but it has begun.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
All right. Thank you very much, guys.
Thomas E. Powell - Teleflex, Inc.:
Thank you.
Operator:
Thank you. And I'm not showing any further questions at this moment. I would like to turn the call back to Jake Elguicze for any further remarks.
Jake Elguicze - Teleflex, Inc.:
Thanks, operator, and thanks, everyone, for joining us on the call this morning. This concludes the Teleflex, Incorporated first quarter 2017 earnings conference call.
Operator:
Ladies and gentlemen, thank you for participating in today's conference. This concludes today's program. You may all disconnect. Everyone, have a great day.
Executives:
Jake Elguicze - Teleflex, Inc. Benson F. Smith - Teleflex, Inc. Liam Kelly - Teleflex, Inc. Thomas E. Powell - Teleflex, Inc.
Analysts:
Lawrence Keusch - Raymond James & Associates, Inc. David L. Turkaly - JMP Securities LLC Brooks E. West - Piper Jaffray & Co. Anthony Petrone - Jefferies LLC Matthew Mishan - KeyBanc Capital Markets, Inc.
Operator:
Good morning ladies and gentlemen, and welcome to the Teleflex Q4 2016 Earnings Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this call will be recorded. I would now like to introduce your host for today's conference, Mr. Jake Elguicze, Treasurer and Vice President of Investor Relations. You may begin.
Jake Elguicze - Teleflex, Inc.:
Thank you, operator and good morning, everyone and welcome to the Teleflex Inc. fourth quarter 2016 earnings conference call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website, and a replay will be available by dialing 855-859-2056, or for international calls, 404-537-3406, passcode, 65576607. Participating on today's call are Benson Smith, Chairman and Chief Executive Officer; Liam Kelly, President and Chief Operating Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Benson, Liam and Tom will provide prepared remarks, and then we'll open up the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to factors made in our press release today, as well as our filing with the SEC, including our Form 10-K, which can be accessed on our website. With that said, I'd like to now turn the call over to Benson.
Benson F. Smith - Teleflex, Inc.:
Thank you, Jake and good morning, everyone. To begin, I'd like to start the call by saying that we are quite pleased with our financial performance during the fourth quarter as our business rebounded nicely from Q3 and we achieved results that exceeded the high-end of our most recently provided constant currency revenue growth and cash flow from operations guidance ranges, while achieving adjusted earnings per share at the top of our most recently provided guidance range. In fact, during the fourth quarter, we saw a stabilization in our end markets and at 6.9% generated our highest constant currency revenue growth since the fourth quarter of last year. And this was no small feat as the fourth quarter of 2015 was a huge quarter for Teleflex and presented us with a very difficult comparable. Strong constant currency revenue growth rates were achieved within each of our product areas and geographies, and that even includes Latin America, which has faced significant headwinds leading up to this most recent quarter. As we exit the year, thanks in part to the investments we have been making in our product portfolio, I feel confident about the state of our base business and believe that we are well-positioned to build upon our base business constant currency revenue performance in 2017. Turning to profitability, during the fourth quarter we generated adjusted operating margin of 25%, which was up 130 basis points versus Q4 2015, at an all-time high, and adjusted earnings per share reaching $2.13. While from a full year perspective, we were able to leverage as reported revenue growth of 3.2% into adjusted earnings per share of $7.34, an increase of 16% as compared to 2015. And similar to my comments regarding revenue, we see 2017 as yet another year in which Teleflex can leverage its base business income statement through a combination of revenue and non-revenue dependent actions, further expanding adjusted gross margins and operating margins as well as adjusted earnings per share. All of my comments regarding our base business will be aided greatly by the recently completed acquisition of Vascular Solutions. We are excited to close this transaction earlier than we initially anticipated, which will allow us to begin integration activities sooner and we'll realize approximately 10.5 months worth of contribution from Vascular Solutions' high growth and high margin product offerings in 2017. I'd like to take this opportunity to welcome the employees of Vascular Solutions into the Teleflex family. We are certainly looking forward to the contributions you will make in the future. And before I turn the call over to Liam, I would like to briefly discuss an announcement that we made this morning regarding my future at Teleflex. Earlier today, we issued a press release announcing my intention to retire as Chief Executive Officer effective December 31, 2017. I've had the pleasure to serve as Teleflex Board member since 2005 and as the Company's CEO since 2011. During my time as CEO, we accomplished a great deal, completing the transformation of a once slow growth, multi-industry company into a pure play medical device company capable of consistent annual revenue growth and significant margin expansion. And as I look ahead, I feel that the end of 2017 is the right time for me to retire as CEO. Our product portfolio is the most robust it's ever been with several products launching that has significant market potential. Our market expansion initiatives are well underway – our margin expansion initiatives rather are well underway and the company has the ability to expand gross and operating margins for several years to come. And the integration of Vascular Solutions will be well underway by the end of this year. I also feel that the management bench strength at Teleflex is very deep, led by the man who will take my place as CEO, Liam Kelly. Liam has been instrumental in the success that Teleflex has had over the past six years and I am pleased that he will succeed me. That being said, Liam, you won't be able to get rid of me that easily as I do plan on running for another three-year Board term with Teleflex. And if elected in May, I will continue to serve as Teleflex's Chairman of the Board. That completes my prepared remarks. At this time, I would like to turn the call over to Liam.
Liam Kelly - Teleflex, Inc.:
Thank you, Benson and good morning, everyone. I greatly appreciate the confidence that you and the Board have in me and I look forward to continuing to execute upon our strategy in the years to come. Turning now to a review of the quarter. As we have been saying for the past several months, we expected distributor ordering patterns to normalize as we moved through 2016, and I'm pleased to report that this occurred as we exited the year. In fact, we saw robust distributor orders in conjunction with an uptick in a flu season whose severity was ahead of 2015 levels and represents a more normalized flu season. This, combined with stronger new product sales and share gains led to our fourth quarter 2016 constant currency revenue growth of 6.9%. This was also aided in part by the one additional selling day we had in quarter four, which we estimate contributed approximately 1%. The primary driver of revenue growth this quarter came from increased sales volume of existing products, which contributed approximately 4.5%. We experienced positive constant currency existing product growth across all our product areas. However, it was largest within our OEM, EMEA, vascular, and anesthesia franchises. Moving to new products. The positive revenue contribution trend we have seen for the past several quarters once again continued in quarter four, this time contributing approximately 1.6% of constant currency growth. This represents the highest constant currency revenue growth contribution stemming from new products yet; acquisitions as well for 2017, as many products which were launched during 2016 are gaining traction. From a geographic perspective, new product revenue growth was again led by our North American businesses. While from a product line standpoint, new product sales were particularly strong within our surgical, vascular, and anesthesia product lines. Surgical new product sales were driven by increased utilization of products used in robotic procedures, further penetration of our EFx offering, as well as an increase in the amount of percutaneous laparoscopy products sold such as Percuvance and MiniLap. Vascular new product revenues increases were attributed to sales of our preloaded antimicrobial and antithrombogenic VPS PICCs. While in anesthesia, the growth is primarily due to increased sales of our LMA Unique products with silicone and the Rusch Trulite laryngoscope. The next largest driver of revenue growth in the quarter was the contribution from acquisitions, which increased 0.4% versus the prior year. This is primarily due to a small OEM acquisition that we made in the third quarter. And finally, during quarter four, we saw another nice uptick in the average selling price of our products, which drove revenue higher by another 40 basis points. This was primarily due to increases in our Surgical and Asia reporting segments. Next, I would like to provide some additional color surrounding our segments and product-related constant currency revenue growth drivers. Vascular North America fourth quarter revenue increased 5.9% to $95.7 million. The increase in vascular revenue was largely due to sales of Vidacare EZ-IO and OnControl devices as well as increased CVC sales. Moving to Anesthesia North America, fourth quarter revenue was $54.9 million, up 8.5% versus the prior year period. Growth in this segment was driven by increased sales of Vidacare EZ-IO, atomization, and airway management devices. And because I know the investment community continues to be interested in this statistic, the Vidacare product line continues to perform exceedingly well, growing approximately 22% globally on a constant currency basis during the quarter. The performance in quarter four resulted in global Vidacare revenue growth of approximately 21% for the full year. Turning to our Surgical North America business, its revenue increased a healthy 12.2% to $48.3 million. The increase within Surgical is primarily attributable to higher sales of access ports, chest drainage products, and polymer ligation clips. Shifting to our overseas businesses, EMEA revenues continue their positive trajectory expanding 3% on a constant currency basis to $135.7 million. The improvement in European revenue was largely the result of increased urology, interventional, vascular, and respiratory product sales. The growth in the region was somewhat offset by lower sales of cardiac products as we continue to work through a back order in that product category. Moving to Asia. Our fourth quarter revenue increased 5.4% to $73 million. This includes China growth, which exceeded 5% in the quarter. China continues to be an important area of growth for Teleflex, and we have decided to permanently exit our relationship with our former master distributor of vascular and cardiac products in China and instead distribute these products through alternative third-party sub-distributors. And while Tom will take you through the financial impacts this will have on our 2017 results in a few moments, I'd like to point out, while this initiative may be slightly dilutive to our 2017 revenue and adjusted earnings per share as our former distributor sells through its remaining inventory and we increase our direct sales presence in the area, we believe this move will allow us to improve margins, get closer to the end users of our products, and gain better control of the sales channel. Turning to OEM, during the fourth quarter, revenue increased 20% to $45.3 million and was primarily due to higher sales of catheters and performance fiber products, as well as a small acquisition closed in late quarter three. And lastly, fourth quarter revenue for the businesses within our All Other category was up 5.5%, totaling $61 million. Growth here is primarily attributable to sales of additional respiratory therapy products, as well as a return to positive growth within our Latin American business. Next, I would like to briefly update you on additional GPO and IDN agreements that we received during the quarter, as well as some recently received regulatory approvals. During the fourth quarter, we won four new agreements and extended another 18. Of the agreements won and extended in quarter four, eight were sole source in nature and cover a variety of clinical areas including our laryngeal masks, laryngoscopes, humidification, CVCs, PICCs, and arterial product offerings. While on a full year basis we won a total of 105 agreements, 50 of which were brand new awards and 59 of which were sole source awards. Similar to my comments regarding the positive trends that we've seen, as we progress through the year in terms of new product revenue contributing to our constant currency revenue growth rate, the GPO and IDN awards that were won in 2016 will position us nicely in 2017 and beyond. Moving next to regulatory approvals. During the quarter, we received 510(k) clearance for the Arrow VPS Rhythm device and Optional TipTracker Technology. This device expands Teleflex's Catheter Tip Navigation and Placement portfolio to now include familiar ECG-only technology for the elimination of confirmatory chest X-ray. This device may be used with a broad range of catheter types and brands and when paired with a single-use TipTracker Stylet for insertion of PICC catheters, the Arrow VPS Rhythm device provides real-time visual navigation. In addition to VPS Rhythm, we also launched the LMA Gastro Airway with Cuff Pilot Technology. LMA and Teleflex were pioneers in the laryngeal mask space and this product is no different as it is the first laryngeal mask designed specifically to facilitate esophageal access and promote airway control during endoscopic procedures. It also features a cuff pressure indicator that constantly monitors cuff pressure, detecting changes resulting from fluctuations in temperature, nitrous oxide levels and movements within the airway. In addition, it also has an integral pipe block to reduce the potential for damage to the endoscope, helping to avoid costly repairs. And it is exactly products like these two that I just mentioned that will allow Teleflex to continue to expand the revenue growth that we generate coming from new product introductions. As this chart depicts, since 2013, we've introduced 88 new products and line extensions to the market. This includes 25 in 2016 alone. And in many cases, it takes time for new products to gain traction in the marketplace. Since 2014 when we generated 0.9% of revenue growth from new product introductions, we've seen an acceleration in total company constant currency revenue growth stemming from new products reaching 1.3% in 2016. This revenue growth is predominantly being driven by the North American market where we typically launch a product first. Within North America, new product revenue growth has accelerated from 0.4% in 2014 to 2% in 2016. And if there was anything that we learnt from 2016, it was that when planning for new product revenue growth contributions we need to take into account the time that hospital value analysis committees can take as part of the process. As such, despite the fact that revenue growth within North America expanded significantly from 2015 to 2016, we are taking a more conservative approach when setting the revenue growth rate associated with new products that comprise our 2017 constant currency revenue guidance range. During 2017, we expect additional new product revenue growth to be driven by the likes of Percutaneous solutions, including Percuvance and MiniLap, the VPS Chlorag +ard Plus, the VPS Rhythm, the AutoCAT 3 (17:34) and the LMA Protector, just to name a few. And finally, before I turn the call over to Tom, I would like to share with you some thoughts on the recently completed acquisition of Vascular Solutions. On Friday, February 17th, we completed the acquisition of Vascular Solutions, and as Benson said earlier, we did so ahead of our initial expectations. We are extremely pleased to have acquired Vascular Solutions as it represents a significant step forward in our strategy. Vascular Solutions is a truly unique company with differentiated technologies that serve the coronary and peripheral vascular markets. And we see this acquisition as very complementary. The combination of Vascular Solutions and Teleflex significantly advances our offering of vascular and interventional solutions as we are adding over 90 proprietary products and services that are sold to interventional cardiologists, radiologists, electrophysiologists and vein specialists. Combined, the new company will offer more than 150 cardiac vascular and interventional products globally. This acquisition also accelerate Teleflex's sales growth trajectory and provides a significant sales channel opportunity. As we said back in December when we announced the transaction, Vascular Solutions have consistently generated greater than 10% revenue growth per year over the last decade, and this acquisition positions Teleflex to have a larger presence in fast growing markets. In addition, we expect to capitalize on Teleflex's significant international infrastructure to drive further penetration outside of the U.S. of Vascular Solutions' products. Another reason we are excited about acquiring Vascular Solutions is its robust R&D pipeline. These products are differentiated, high growth and high margin products that have demonstrable clinical benefits that address complex interventions, radial artery catheterizations and embolization procedures, all areas of clinical practice that Teleflex knows a lot about. And finally, this acquisitions has compelling financial profile that substantially improves Teleflex's revenue growth, margins, earnings, and cash flow generation capabilities for the years to come. We expect that this transaction will contribute between 8.5% to 9% of constant currency revenue growth during 2017 and that it will be accretive to adjusted earnings per share in 2017 by $0.20 to $0.25. This includes the impact of incremental interest expense associated with financing the transaction. Importantly, this transaction meets all of the M&A objectives we've been talking about for the last several years, which include
Thomas E. Powell - Teleflex, Inc.:
Thanks, Liam and good morning, everyone. Given the previous discussion of the company's revenue growth drivers, I'll begin my prepared remarks with gross profit. But before I do, I'd like to reinforce the point that Teleflex delivered very solid 2016 financial result despite softer than expected revenue growth. For the year, we grew adjusted net income by over 18% and cash flow from operations increased by 35%. We also achieved or exceeded each of the non-revenue financial metrics outlined at the beginning of the year. The combination of manufacturing productivity programs, mix management and pricing increased the gross margin by 140 basis points to 54.1%. Tight control over OpEx spending and the deferral of the medical device tax provided for an increase to the operating margin of 260 basis points to 24.1%. We attribute approximately 70 basis points of the increase to the deferral of the medical device tax. Strong financial results allowed us to raise adjusted EPS guidance on three occasions throughout the year with full-year EPS of $7.34 coming in at the upper end of our most recently provided guidance range. Finally, during 2016 we announced two additional restructuring programs that will yield further savings beginning in 2017. Turning now to fourth quarter results. For the quarter, adjusted gross profit was $276.7 million versus $262.2 million in the prior year quarter. Adjusted gross margin was 53.8%, representing a 30 basis point decrease when compared to the prior year period. For the quarter, we realized benefits from new products, pricing and manufacturing productivity initiatives. However, unfavorable foreign exchange rates reduced gross margin by approximately 70 basis points. Adjusted operating margin improved by 130 basis points to 25%. The year-over-year improvement was largely the outcome of continued tight control of discretionary overhead spending and the deferral of the medical device excise tax. Foreign currency had an unfavorable impact of approximately 50 basis points. Adjusted income from continuing operations before interest and taxes increased by 11.9% in the fourth quarter. For the quarter, adjusted net interest expense increased to approximately $11.7 million from $10.2 million, reflecting the impact of the issuance of the 4 7/8 senior unsecured notes last May. Also in the quarter, the adjusted tax rate was 16.5% versus 13.6% in the prior year quarter. On the bottom line, fourth quarter adjusted earnings per share was $2.13, or an increase of 6%. The rate of increase versus 2015 was dampened by a tough tax rate comparable, the increase in interest expense and unfavorable foreign exchange. Turning now to select balance sheet and cash flow highlights. For the year, cash provided by operations was $411 million or an increase of 35% over the prior year. The increase was primarily the outcome of improved operating results, improved working capital management and reduction in tax payments. At year-end, cash on hand totaled approximately $544 million and pre Vascular Solutions leverage stood at approximately 2 times. If you were to pro forma the Vascular Solutions acquisition into our results, our Q4 leverage ratio would have been approximately 3.57 times. That completes my comments on 2016. Now I'll move to 2017 guidance. Beginning with revenue, for 2017, we expect constant currency revenue growth of between 12.5% and 14%. Included in our revenue guidance is the assumption that our base business grows between 4% and 5% on a constant currency basis. Base business constant currency revenue growth is expected to be driven by a core product volume increase of between 1.8% and 2.4%. New products are expected to deliver between 1.4% and 1.6% of growth. This compares to growth of 1.3% in 2016. Net pricing in our core business is expected to be up year-over-year by 50 basis points to 60 basis points. The improvements are primarily due to our decision to eliminate our former master distributor in China, coupled with modest pricing improvement on existing products. For the base business, we project previously completed M&A to contribute between 30 basis points and 40 basis points of revenue growth in 2017. This is comprised solely of the OEM acquisition that was completed last September. Finally, it is our expectation that Vascular Solutions will contribute between 8.5% and 9% of total constant currency revenue growth. This represents Teleflex owning Vascular Solutions for approximately 10.5 months during 2017. Given its track record of consistently growing annual revenues 10% or more, we anticipate that when Vascular Solutions rolls into our organic growth statistics, it could add approximately 1% per year towards Teleflex's overall revenue growth rates. Lastly, our assumption is that FX will create a 2.5% headwind, and as a result, we expect as reported revenue to increase by 10% to 11.5%. Based on our currency assumptions, this translates to an as reported revenue range of $2.055 billion to $2.083 billion. The stronger U.S. dollar relative to the euro is the primary driver of the 2.5% foreign exchange headwind impacting our as reported revenue in 2017. And for 2017 planning purposes, we assumed a euro to U.S dollar exchange rate of $1.04, which closely approximates today's spot rate. Turning next to gross margin. For 2017, we expect to be able to continue the positive momentum that we've had over the past several years when it comes to the expansion of our adjusted gross margin. During 2017, we anticipate that adjusted gross margin will increase other 130 basis points to 190 basis points to a range of 55.4% to 56%. These gains are expected to be primarily driven by annual cost improvement programs, benefits from our previously announced 2014 and 2016 restructuring programs, favorable product mix, improved pricing, and the acquisition of Vascular Solutions. Of the expected 130 basis points to 190 basis points of annual margin gain, approximately 100 basis points to 140 basis points is attributed to the Teleflex base business, while Vascular Solutions is expected to add between 30 basis points and 50 basis points. Gains in this area will be somewhat offset by the negative impact from FX, which we estimate to be approximately 30 basis points. Moving to adjusted operating margin. We anticipate that our adjusted operating margins will increase by approximately 150 basis points to 220 basis points to a range of between 25.6% and 26.3% in 2017. Gains from gross margins will be the principal driver of the increase. However, we will look to further accelerate those gains through a combination of SG&A cost control programs and the restructuring program announced in September of 2016 that had a focus on operating expense savings. These actions will provide improved flow-through from gross margin to operating margin, while also providing us flexibility to further invest in R&D initiatives in both our Vascular and Surgical businesses, as well as to selectively invest in sales force capabilities to support the introductions of new products and the China Go-Direct. Of the expected 150 basis points to 220 basis points from adjusted operating margin gains, approximately 110 basis points to 170 basis points is being sourced by the Teleflex base business, while Vascular Solutions is expected to add between 40 basis points to 50 basis points. Finally, similar to gross margin is our expectation that FX will be a headwind of approximately 30 basis points on the operating margin line. That takes me to our preliminary adjusted earnings per share outlook for 2017. This slide serves as a bridge from our full year 2016 adjusted EPS to our full year 2017 adjusted EPS outlook. Beginning with 2016 adjusted EPS of $7.34. From an operating standpoint, in 2017 we project our base business will add approximately $1.12 per share to $1.17 per share or a growth of approximately 15% to 16%. Inherent in this earnings range is the expectation that our 2017 base business adjusted tax rate will be in the range of 16.5% and 17.5%. 20 basis points of the improvement in the tax rate versus 2016 can be attributed to the new accounting treatment for excess (30:37) tax benefits and stock plan. In arriving at the 20 basis point rate impact, we have only considered divesting of restricted stock, as all of the factors necessary to value the windfall benefit from stock options are not easily determined in advance. And we will provide transparency on this item during the course of the year. The balance of the improvement in our tax rate is the result of a combination of benefits we saw in our fourth quarter earnings mix that we expect to continue into 2017, and distinct sustainable planning opportunities that we have identified. Of note, we expect that the inclusion of Vascular Solutions will increase the consolidated Teleflex 2017 adjusted tax rate by 50 basis points to a range of 17% to 18%. Moving to the next item. In 2017, we have plans to eliminate our master distributor of vascular and cardiac products in China, which will create a transition year earnings headwind of $0.12 to $0.15. Next, as a result of the 4-7/8 senior unsecured note offering concluded May of 2016, interest expense on the core Teleflex operations is expected to be a headwind of between $0.08 and $0.09. Moving on to share count. Our current estimate is for adjusted weighted average shares to increase to approximately 46.3 million to 46.4 million for the full year of 2017. As a result of the share increase, our earnings per share growth will be reduced by an estimated $0.11 per share to $0.12 per share. And turning to FX, based on our current estimates, we expect foreign exchange will create an adjusted earnings per share headwind of approximately $0.30. And finally, we expect Vascular Solutions acquisition to contribute between $0.20 and $0.25 of adjusted earnings per share for 2017. This earnings range assumes the full interest expense burden of financing the transaction at an average rate of approximately 4.2%. In aggregate, our outlook for 2017 adjusted earnings per share is $8 to $8.15, representing growth of between 9% and 11% versus 2016. And while it is not our practice to provide specific quarterly guidance, I did want to highlight some considerations regarding variability between our 2017 quarterly expectations. Overall, we expect revenue growth rates will be high in Q1, largely due to the first quarter having five additional shipping days as compared to the prior year period and the partial quarter addition of Vascular Solutions. We estimate the five additional days will increase revenue growth by approximately 5%. We will then have one fewer selling day in the second quarter and five fewer selling days in the fourth quarter. Overall, we will have one fewer selling day in 2017 as compared to 2016. With that being said, despite the five additional selling days in Q1, we expect the first quarter of the year to be lowest in terms of actual dollar amount of revenue reported. In part, this is due to the fact that we have only a partial quarter of Vascular Solutions revenue in our results. As we move throughout the remainder of the year, we anticipate that revenue dollars grow substantially from Q1 to Q2, reduce slightly from Q2 to Q3 thanks to the normal European slowdowns, and then accelerate again from Q3 to Q4. While from an adjusted earnings per share standpoint, for 2017, we expect the quarterly EPS seasonalization to closely approximate the seasonalization of EPS we experienced in 2016. And that concludes my prepared remarks. At this time, I'd like to turn the call back over to the operator for questions. Operator?
Operator:
Thank you. And our first question comes from Larry Keusch with Raymond James. Your line is open.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Thanks. Good morning, everyone.
Benson F. Smith - Teleflex, Inc.:
Good morning, Larry.
Liam Kelly - Teleflex, Inc.:
Good morning, Larry.
Lawrence Keusch - Raymond James & Associates, Inc.:
So, I just – two questions for you. I'm just wondering if you can come back a little bit to the 4% to 5% organic growth. And again, just help us think through what kind of are the drivers of that growth rate, just given some of the challenges that you had in 2016 achieving your initial outlook?
Liam Kelly - Teleflex, Inc.:
Okay, Larry. Liam here. I'll take that one. So, as we outlined in the call, from a volume perspective 1.8% to 2.4%. We're accelerating new products from the 1.3% that we finished 2016 to a 1.4% to 1.6% range. And as we said during the call, we see that being somewhat conservative, but we are contemplating that we will get through these value analysis committees, in particular with products that we launch during 2016. We have accretion on our pricing from 0.4% in 2016 to the range of 0.5% to 0.6%. That's being driven by a positive base pricing, but also with the action that we're taking with our China distributor adding some pricing there. And of course, CarTika adds 30 basis points to 40 basis points. A few macro impacts – and of course Vascular Solutions then on top of that to go from 4% to 5% to 12.5% to 14% on a constant currency basis. Then there are a few macro factors. So the headwinds that we saw as we said previously within Latin America, we expected that to be behind us as we entered quarter four. And I am happy to report, Larry, that Latin America had a robust quarter four, growing in the region of about 8%. We also anticipate a recovery in EMEA in – next year. On a full-year basis this year, EMEA grew by about 1.1%, Larry, and in the latter half of the year in quarter three, EMEA grew by over 2% and with an extra billing day in Q4 grew by 3%. So, we've a reasonable trajectory within EMEA to get us there. And of course, our key North American market, Larry, we expect to see robust growth as we have seen, aided by those new products that I mentioned earlier.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. That's perfect. And then, just one other one for Tom. I think I caught this correctly in the release, but it looks like there was an impairment charge for Semprus, I believe which was in the fourth quarter. So, is that correct, and if it is, if you could just take me through what the deal was there?
Thomas E. Powell - Teleflex, Inc.:
Okay. So, that is correct. So, the financial impact is an impairment charge offset by a deferred tax liability. Those two net to about $26 million. We also then reduced contingent consideration payment as well. Kind of the background there is, Teleflex as a company is always working on a number of products. In this case, looking for coatings that will reduce antithrombogenic and have antimicrobial properties. What we found, Larry, is that – we've got other technologies in our portfolio that are showing a lot of promise on both of those fronts. Semprus was more focused on the antithrombogenic. And so we made the decision to focus our resources on that – another coating technology that we think shows more promise. And so, that's kind of the background on the decision.
Liam Kelly - Teleflex, Inc.:
And I'll just add to that a little bit Larry that hospitals are now being penalized for the last 18 months on their infection scores on PICCs, and we believe that as Tom said, an antithrombogenic and an antimicrobial solution is really where the market is moving. And we have some better solutions that we're working on internally that addresses both. Semprus was clearly an anti-adherence technology, so therefore had an impact on thrombus, but not on infection rate colonization.
Lawrence Keusch - Raymond James & Associates, Inc.:
And when – just lastly, when could we potentially see any new product introductions with the newer technology that you are referencing?
Liam Kelly - Teleflex, Inc.:
So, we are working on some technologies that will be slated for a 2019-2020 release at this stage, Larry.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Perfect. Thanks, guys. Appreciate it.
Operator:
Thank you. And our next question comes from Dave Turkaly with JMP Securities. Your line is open.
David L. Turkaly - JMP Securities LLC:
Thanks. And congrats, Liam. And Benson, I know you are staying around, but I think we knew this was eventually going to occur. I guess just at a high level, I'd love to just kind of get your thoughts on sort of the margin expansion story that we've seen over the last several years. And obviously, we see the guidance for 2017, but should we still anticipate that you might be able to do 100 basis points to 200 basis points moving forward. And sort of any color you could give us on sort of long-term gross or operating margin levels, now that you have Vascular Solutions in the portfolio as well.
Benson F. Smith - Teleflex, Inc.:
So we have consistently presented that 350 basis points to 400 basis points as a conservative goal for the end of 2018. As you know, we did not include the potential margin improvement from acquisitions such as Vascular Solutions in that total, now did we include our China Go-Direct program in that. So I would say that of the view we would give it to (41:05) that is, is that those two events would be additive to that 350 basis points to 400 basis points goal. Our current thinking at this point, given the fact that that 350 basis points to 400 basis points contains a number of different programs is to have an Analyst Meeting sometime during the course of this year. I think September now is looking like the most likely date where we can go into more details and I think give you a much more definitive viewpoint in terms of what 2018 is really going to look like. But at this point the assumption you should be making is that those two elements are additive. And at that point also I think we want to go beyond what 2018 is going to look like and give you a couple years forward moving picture as well, because just including the various programs we have, many of them won't have been completed by 2018. But I would say, our margin expansion remains a very, very strong opportunity for us for the next three years to four years.
David L. Turkaly - JMP Securities LLC:
Great. And then just one quick follow-up. I know the Penn medical deal was not a large one, but just curious as to how that kind of fits in with Vidacare. I know it grew well in the quarter. But is it similar, is it complementary, or how exactly will those two – how would you sell those two in the market?
Liam Kelly - Teleflex, Inc.:
So it's quite complementary and it actually brings a broader range of portfolio of products as well. So Penn commercializes trauma and resuscitation products as well as frontline (42:41) products. They are the I think Enteropathy's (42:46) product of choice predominantly with the military. We also have a strong relationship with the military, but this just adds an additional portfolio to Teleflex. We don't expect it to have a significant impact on revenue or earnings during 2017, but it also brings some valuable IP that will help to support the EZ-IO product into the future. And I would say, David, is it still needs shareholder approval before it closes, so just bear that in mind.
David L. Turkaly - JMP Securities LLC:
Great. Thanks a lot.
Operator:
Thank you. And our next question comes from Brooks West with Piper Jaffray. Your line is open.
Brooks E. West - Piper Jaffray & Co.:
Hi, can you hear me?
Benson F. Smith - Teleflex, Inc.:
We can, Brooks. Good morning.
Brooks E. West - Piper Jaffray & Co.:
Great. Good morning, and congratulations to you Benson and Liam, both. I wanted to start with China if I could. You gave some good detail on the earnings impact. And I'm wondering if you could quantify any revenue impact with that transition that we should expect in 2017? And then, is this something that you can do in a year or is this something that is going to linger on for some time? And I guess, last question there is, just if can you give us a sense of the scale of your China business?
Liam Kelly - Teleflex, Inc.:
Okay. So there is a lot in there, Brooks. It's Liam here, so I'll try and grab them one at a time. So the distributor will sell through what inventory did they have during the year. It will have an impact on our revenue line. At the moment, we estimate that to about 30 basis points, which is included within our volume guidance that we gave. The impact thereafter, it becomes accretive in 2018, 2019 and 2020. During 2017, you will also see that we have additional pricing as a result of this. So we lose volume, we lose earnings, but we do pick up some modest pricing in the region of about, let's call it at 30 basis point or 40 basis points of additional pricing as a result of this. So we anticipate that as the distributor sells through their inventory, we will put in our sales organization into the Chinese market. Our overall business in Asia is – or in China is in the region of about $85 million, Brooks, and this represents at (45:23) between $26 million and $30 million for Teleflex in 2016.
Brooks E. West - Piper Jaffray & Co.:
Okay. So, thanks for that, Liam. And it sounds like you can execute this in one year and you're confident that this move becomes an accretive in 2018. Is that the way to think about it?
Liam Kelly - Teleflex, Inc.:
That's the way to think about it. It will be accretive in 2018 and 2019, Brooks.
Brooks E. West - Piper Jaffray & Co.:
Okay. Perfect. And then Tom, I have one for you, follow up, just on gross margins this quarter. You mentioned FX was a headwind, but given – I think backing that out, you're a little bit light of our model. I'm just curious
Thomas E. Powell - Teleflex, Inc.:
Sure. So, the fourth quarter margin was on the lower side of what we've put up there. I think the biggest impact is we saw about a 70 basis point negative impact coming from FX throughout the – or I should say through the first three quarters of the year. We had seen some very moderate positive impacts on gross margin from currency, but the fourth quarter impact erased all those gains. So that was a big shift in the trend line. And then you also recall our decision to delay the transfer of the wet kits. We discussed this earlier in the year. That would have had an impact in the fourth quarter as well. And then in addition, there was some mix. We had unusually strong growth in our OEM respiratory business units as well as the Latin America region, and these collectively are our lowest margin region and business units. So, that was a mix impact as well. As we think about this going forward, obviously we thought about our longer term mix and have modeled that into 2017. In any quarter you can have peaks and valleys in product lines. We don't expect that these three product lines will necessarily cause a mix issue going forward for us. We'll have to see on the impact from currency. As mentioned in our guidance, we have anticipated there will be an FX impact, and that's in our assumptions. And we expect to be able to work through the wet kit transfer issue in the coming quarters and put that behind us. So I don't see this as really having a long-term impact for us as a result of these three items.
Brooks E. West - Piper Jaffray & Co.:
Great. Thank you.
Operator:
Thank you. And our next question comes from Matt Taylor with Barclays. Your line is now open.
Unknown Speaker:
Hi. This is actually Ian (48:02) in for Matt. Can you hear me okay?
Benson F. Smith - Teleflex, Inc.:
Yes.
Liam Kelly - Teleflex, Inc.:
Hi, Ian, (48:07) we got you.
Unknown Speaker:
Okay; great. I want to ask, on the acquisition of Vascular Solutions, what is the blue sky scenario? In other words, what are the things that could go better than expected that could lead to upside from the scenario you laid out?
Liam Kelly - Teleflex, Inc.:
So it's Liam here, Ian (48:25). So Vascular Solutions have traditionally been quite aggressive with product launches. You will see that they just launched the TrapLiner which is an extension of their core GuideLiner product. So of their, call it, $170 million a year, about $50 million comes from this GuideLiner product. The TrackLiner was initially thought to cannibalize a larger portion of the GuideLiner. Having done some of the clinical work in Canada and in Europe, the feedback from the clinicians is that it will be used more in conjunction with the GuideLiner, so the cannibalization rates will be slightly lower. So that's the potential for upside. In the longer term, if I stick with the new products theme, freeze-dried plasma could be a significant opportunity in the future. We have a strong military call point. This is a product that will be sold through that call point. The proposed deal we have with Ping (49:37) strengthens that call point into the military. So we think that will be accretive. And their top-line sales growth will be reinforced by our international channel, and we think that's the potential for some further upside perhaps in the future.
Unknown Speaker:
Okay. That's helpful. I want to follow up with another question on the launch of Percuvance. Do you have a little bit more detail there just in terms of – at this stage, what the feedback has been like and how it is progressing through the value analysis committees?
Liam Kelly - Teleflex, Inc.:
So, again, the feedback is resoundingly positive. We have put the product portfolio of Percutaneous Solutions, which is Percuvance and MiniLap, into the hands of our full sales force now and put more resources behind this. In the U.S., we have 24 hospitals using it of 36 that have been through the VAC through quarter four, which is a 68% hit rate, which is consistent with our success rate going through VAC. We have 35 trials ongoing in North America and 60 ongoing globally. We're still very enthusiastic about the product. Feedback from the customers and surgeons continues to be resoundingly positive, and we're just working through the Value Analysis Committees through this year and what we expect to see as we get through those is the revenue to ramp through the year and to have more of an impact in 2018.
Unknown Speaker:
Great. Thank you.
Operator:
Thank you. And our next question comes from Anthony Petrone with Jefferies. Your line is open.
Anthony Petrone - Jefferies LLC:
Thanks and good morning. Congratulations also – Liam and Benson, congratulations to you both. Just a couple questions on Vascular Solutions and then a follow-up maybe on tax. The $0.20 to $0.25 for 2017, I am just wondering with the margin profile on those revenues are considered in that guidance and what percentage of the $40 million to $45 million target by 2019 in cost synergies is baked into that number?
Liam Kelly - Teleflex, Inc.:
So, I'll cover the margin side of it first. So, it's accretive to our overall margins. Now, there will be some adjustments as we walk through Vascular Solutions. They count certain expenses below the line that we would account in gross margin. But their gross margins have been in the 66% range as they have reported them. From the point of view of synergies, clearly we just closed this a week ago. We're working through that. Clearly, we have a plan there, but we don't anticipate significant synergies in 2017, but obviously that will ramp as we get through 2018 and 2019 and I think we are pretty consistent by 2019, we will generate between $40 million and $45 million in synergies from this transaction.
Anthony Petrone - Jefferies LLC:
Great. And then a follow up just on Vascular Solutions would be, if we look at the growth profile prior to the deal being announced, the Turnpike catheters within their portfolio were really experiencing hyper growth. And I am just wondering where that product cycle is, how long do you expect that to sort of maintain at that level? And then the follow up for Tom on tax guidance would be, what is sort of baked in there for potential reform later this year, just given the proposals that we're seeing? And I guess, as of this morning they are expecting that to be presented before the August recess. So anything on tax guidance would be helpful.
Liam Kelly - Teleflex, Inc.:
So, I'll address the Turnpike first (53:36) that's okay. So, the Turnpike product, we're very excited by it, we love the growth profile of it, we love the margin profile of the Turnpike product. The growth of the Turnpike in quarter four was almost 200%, albeit on a relatively small pace. We see this as an additional opportunity in the hands of Teleflex, because a lot of their distribution channel overseas – or some of their distribution channel overseas at least does not to sell the Turnpike, they sell the competitive product that they had taken onboard as a distributor would, prior to the launch of Turnpike. So we actually see the lifecycle of that in the early stages of lifecycle for the Turnpike with many years of accretive growth to come for Teleflex and accelerate this by what we can do with our channel overseas.
Thomas E. Powell - Teleflex, Inc.:
And then on the tax rate, our approach and planning for 2017 was to develop our plan based on the prevailing or current tax builds (54:42) out there for the U.S. and abroad. We have not yet factored in any potential revisions, and so what we'll wait to do is, see what's actually coming out in terms of legislation. And once that becomes clear, we'll make an assessment of the impact and provide updates. But we thought it's premature right now to incorporate any conceptual proposals into the financial plans.
Benson F. Smith - Teleflex, Inc.:
This is Benson. I spent a good bit of time in Washington two weeks ago, and I would say while there is a lot of enthusiasm to get something out there relative to tax reforms, there is still a lot of disagreement under the surface in terms of what that really looks like. So, I think the approach of wait and see is important. There can be a lot of negotiation between now and some final proposal.
Anthony Petrone - Jefferies LLC:
That's helpful. Thank you.
Operator:
Thank you. And our next question comes from Matt Mishan with KeyBanc. Your line is open.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Hey. Good morning, everyone.
Benson F. Smith - Teleflex, Inc.:
Hi.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Just a follow up on the tax discussion. Tom, like in 2014, you were able to repatriate some cash following Vidacare. Do you think you still have the same opportunity to do that following Vascular Solutions? And then, how are you kind of balancing the need to issue high yield with potential tax reform?
Thomas E. Powell - Teleflex, Inc.:
Well, that's something that we're obviously watching very closely. As we talked about, the whole Vascular Solutions acquisition, we initially funded that on a revolver and bank term loan, and we are going to opportunistically look to see if there is an opportunity to turn that out with high yield. Now, to the extent that either the current administration creates a repatriation opportunity or we are able to create one ourselves internally, would cause us to reassess that financing strategy, because obviously we have over $500 million of cash sitting O.U.S., and that could help us to delever and perhaps take an alternative path. But we're working through the whole question on repatriation I guess by ourselves, and we want to wait and see what happens with the current administration's plans on that. So, we are watching it closely obviously.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Okay, perfect. And then I'm just trying to understand the sustainability of the North American surgical results. I think you have an expectation for a ramp in Percuvance. Are we talking like single-digit millions in 2017, or are we getting up to double-digit millions? And then could you remind us your exposure to the Intuitive robotics platform?
Liam Kelly - Teleflex, Inc.:
Okay, so it's Liam here again. So within percutaneous, you have Percuvance and MiniLap. So they both address that category of percutaneous solution. We don't normally give specific guidance for individual product categories, but as I said earlier, we expect it to ramp and to be accretive to our new product revenues that we will ramp-up during 2017. On the Intuitive side, we do sell a range of products to Intuitive that – our trocars predominantly that are sold as part of their platform and that generates approximately 30 basis points to 40 basis points of growth – of revenue globally.
Benson F. Smith - Teleflex, Inc.:
We don't see that, that growth would compromise the Percuvance opportunity in any significant way.
Liam Kelly - Teleflex, Inc.:
Correct.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
All right. Thank you very much guys.
Liam Kelly - Teleflex, Inc.:
Sure.
Operator:
Thank you. And I am showing no further questions at this time. I would like to turn the call back to Mr. Jake Elguicze for any closing remarks.
Jake Elguicze - Teleflex, Inc.:
Thanks, operator. And thanks everyone that joined us on the call today. This concludes the Teleflex Inc. fourth quarter 2016 earnings conference call.
Operator:
Ladies and gentlemen, thank you for participating in today's conference. This concludes today's program. You may all disconnect. Everyone, have a great day.
Executives:
Jake Elguicze - Treasurer and VP, IR Benson Smith - Chairman and CEO Liam Kelly - President and COO Thomas Powell - EVP and CFO
Analysts:
Larry Keusch - Raymond James Brooks West - Piper Jaffray Kristen Stewart - Deutsche Bank David Lewis - Morgan Stanley Anthony Petrone - Jefferies Matt Mishan - KeyBanc Brian Weinstein - William Blair Matt Taylor - Barclays
Operator:
Good day ladies and gentlemen and welcome to the Third Quarter Teleflex Inc. Earnings Conference Call. At this time all participants are in a listen-only mode. [Operator Instruction] As a reminder the conference call is being recorded. I would now like to introduce your host for today’s conference, Mr. Jake Elguicze, Treasurer and Vice President of Investor Relations. Sir you may begin.
Jake Elguicze:
Thanks, operator, and good morning everyone and welcome to the Teleflex Inc. third quarter 2016 earnings conference call. The press release and slides to accompany this call are available on our website www.Teleflex.com. As a reminder this call will be available on our website, and a replay will be available by dialing 855-859-2056 or for international calls 404-537-3406, pass code 97714633. Participating on today’s call are Benson Smith, Chairman and Chief Executive Officer; Liam Kelly, President and Chief Operating Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Benson, Liam and Tom will make some brief prepared remarks, and then we will open up the call to Q&A. Before we begin, I’d like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are in fact forward-looking in nature, and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that can cause actual results or events to differ materially include but limited to factors made in our press release today, as well as our filings with the SEC including our form 10k that can be accessed on our website. With that said I would now like to turn the call over to Benson.
Benson Smith:
Thank you, Jake. Good morning everyone and thank you for joining us this morning. To begin with we are very pleased with our overall financial results for the quarter. As reported on revenue growth number of 2.7%, we increased our adjusted gross margin by 6.6%, adjusted operating margin by 14.7%, adjusted EPS by 12.5%, and had excellent cash accumulation. For the year to-date picture looks even better. By any measure that demonstrates examinant financial leverage throughout our P&L. Longer-range, based on our results this quarter we feel very good regarding our cumulative 16, 17, and 18 expectations. This quarter was without questions one of those occasions where we have demonstrated that we have several different levers to continue to drive shareholder value. We did expect to see an uptick in constant currency revenue between second and third quarter which did not materialize. To have reduced our full-year revenue guidance and when pretty sure that many of your questions will be around revenue. Tom, Liam, and myself will of course cover other areas where we want to provide as much clarity as we can around our revenue numbers. We had three primary causes responsible for revenue shortfall. And while they are affecting our 2016 guidance, none of them give us particular alarm relative to our longer-term outlook. Why do I say that, because underneath the surface are some very encouraging signs in products and markets that are particularly important to us from a sustainable growth perspective. We will elaborate on those points during the course of our discussion today. I would like to begin by just briefly reminding you of Teleflex Inc. overarching strategies. We believe that the number one growth market in terms of the size and impact of Teleflex over the next 10 years is the United States. The U.S. has more than just an aging population, most countries have that. We believe the U.S. is best equipped in terms of resources to take care of that population, and least likely to engage in rationing our arbitrary cutbacks in healthcare spending as a result of the sluggish GDP. For us, the United States is in the bull’s-eye of where we want to grow. With the right portfolio enhancements we believe it is possible that our U.S. medical devise business can grow significantly over the next 5 to 10 years. The only other markets with large populations that we see capable of growing at or above high-single-digit rates are China and India. But even in those markets we’re more selective. We want to grow in product areas that are least likely to be replaced by local manufacturing and worth the investment in clinician training. The other two markets of significant size our EMEA and Japan. We do not see these markets growing as fast, and have pegged them to low-single-digit growth. In these markets we need to pay attention to products that are associated with above average procedural growth rates. There are some risks though. In the currency forecast we see several years of potential weakness compared to the dollar. Constant currency growth revenue is an interesting metric, but it’s as reported revenue is continually eaten away by falling currencies, it is not growth that helps your P&L or generate cash. When we look at the rest of the world we see an increasing risk from either economic or political uncertainty, and likely higher volatility with their currencies. Looking back to 2011 one of my early observations was we were over it exposed in EMEA, at least compared to other U.S. based medical device companies. The consequences of this became very apparent to us as we approach 2015 and were staring at a $0.87 currency headwind. We intentionally want to reduce this exposure by growing faster in the U.S. and other markets such as EMEA and Japan. Another key part of our strategy is that we have unique opportunity to continue to improve our gross margins. Not just through 2018 for several years after that. These opportunities are not revenue dependent, and will allow us to get the maximum earnings leverage from our revenue growth. It is our deliberate intention to use this opportunity to enrich our portfolio, and have a greater portion of our revenue in markets and products where growth is both sustainable and defendable. When we review the revenue growth this quarter against this backdrop, for the third quarter, were not ecstatic. But we’re not worried either. We are growing where we want to grow and in product that we want to grow in. Furthermore all of our leading indicators are very positive. Now let me get back to the three factors around our third order revenue. First, our sales into the U.S. distributors continues to lag behind their sales into hospitals. We received tracing data from our distributors. So we know what end user hospitals are purchasing. When we combine our direct sales into hospitals, plus our distributor’s sales into hospitals, we see a very healthy trend for both improved volumes and from newly won accounts. We’re gaining accounts and we’re growing share at a good pace. What causes this lag is primarily flu related. How do we know that? Because we only see these discrepancies in products that are influenced by the flu. We don’t see it at all in any of our surgical products for example, but we see a much more profound impact invest for access and certain anesthesia products. At some recent investor conferences I made a comment about lack of visibility. What I was referring to specifically was this dealer ordering pattern around the flu season. Sometimes it starts to occur as early as September, this year we did not see that uptick. Sometimes it occurs in the very last few weeks of December, and it is one of the reasons that we typically have a strong end to our fiscal year. We also cannot predict the severity of the flu season. In the 2015 to 2016 season it turned out to be almost nonexistent. While the year before was pretty severe. The two years prior to that pretty normalized. It is one of those variables that makes pinpoint forecasting for us around the third and fourth quarter a little problematic. That ambiguity is principally what is driving our current revenue guidance range. We see a normal year and purchasing pattern from distributors. We should be at the high end of our revenue range. But for some inexplicable reason the distributors do not restock we could be at the lower end of our revenue range. The second issue for us in the quarter relates to revenue from new products. Coming into the year one of our biggest single areas of expected revenue growth for 2016 came from the thought that there would be a significant jump in the contribution for new products. It is taking us longer than we anticipated to get these products through the value analysis committees which have been installed at almost every major hospital. By mid August it became readily apparent that summer vacations weren’t going to help either. The net effect is that products are expected to get through these communities by the end first quarter are for the most part just now gaining community approvals. The math here is pretty simple, instead of nine months of revenue for new product in 2016 we will get three months of revenue. While this is frustrating it is not at all discouraging and we’re not discouraged. It is taking longer, but our success rate in getting these products through these communities as high. And we are seeing continued improvement in our contributions for new products particularly in the U.S. where we tend to launch them first. Liam will go over the numbers with you. It is a very good trend. Finally we’re seeing greater than expected weakness in certain geographic markets were local economic conditions continue to be distressed. We thought we were conservative in our expectations, but retrospectively we could be even more conservative. Oil producing countries are still in a difficult position, and some Asian basin countries are experiencing greater than expected slowdown in their healthcare spending. Some of these locations may continue to be a drag on constant currency growth. But we do not consider this to be high-quality growth, and we do not plan to chase this growth into the future. On that point, we continue to be focused on this notion of high-quality revenue growth is being as important if not more important than just the overall number. We have a lot of discipline about the products that we select to put insignificant sales and market resources behind. I personally believe the strategy makes us much less vulnerable to the pricing pressure we’re likely to see is healthcare expenses escalate in almost every country, and should make us less vulnerable to currency volatility. In spite of some softness in our revenue numbers we show great strength throughout the rest of our P&L. We see several years of continued gross and operating margin expansion ahead of us. We are confident in our ability to achieve our previously provided long-term goals, and see lots of encouraging trends. Still, any sustained progress in a complex environment always involves overcoming challenges. And, you cannot always anticipate what those challenges will be. That’s where and why good management teams make a difference. Track records count. Personally, I have tremendous confidence in our team, and in their track record, and our ongoing commitment to investors. With that let me turn this over to Liam.
Liam Kelly:
Thank you Benson and good morning everyone. For the consolidated company, third quarter 2016 constant currency revenues grew 3.1%. The primary driver of revenue growth this quarter came from increased sales volume of new products which contributed approximately 1.3%. New product sales were particularly strong within our surgical, vascular, and anesthesia product line. Surgical new product sales were driven by increased utilization of products using robotic procedures, further penetration of our EFX offering as well as increased in the amount of percutaneous laparoscopic products sold such as Minilap. Vascular new product revenue increases are attributed to sales of our preloaded antimicrobial and antithrombogenic VPS pace. While in anesthesia the growth is primarily due to increased sales of our Rusch Disposable LED Laryngoscope and LMA unique products with silicone. The next largest driver of revenue growth in the quarter was sales of core products which increased 0.9% versus the prior year. Growth here was driven primarily by two areas, OEM and EMEA. Despite the third quarter improvement as compared to the prior year third quarter, it is our belief that core product volumes were lower this quarter as compared to Q2 due to the distributor destocking issue that Benson referred to earlier. Turning to other components of revenue growth. During quarter three we saw a nice uptick in the average selling price of our products, which drove revenue higher by approximately 0.7%. This was primarily due to increases in Asia as well as increases within our surgical and vascular product lines. Finally, during the third quarter, acquisitions added approximately 0.2% of growth. This was primarily due to a small acquisition that occurred within our OEM business. North American growth for Q3 was approximately 3.6% with approximately 2.2% of that growth coming from new product. As Benson mentioned earlier, the new product revenue growth within North America in Q3 of 2.2%, was an acceleration from the 1.2% growth rate in Q1, and the 1.6% growth rate in Q2. This supports the hypothesis that while value analysis committees have slowed the adoption of new products, we’re still seeing an incremental improvement in new products in the North American market. Staying with North America and as Benson mentioned earlier, our direct sales combined with distributor tracing show a more robust picture of end hospital sales demand than our reported sales. Again this makes us feel confident in our ability to achieve our revised full year revenue guidance range. Next I would like to provide some additional color surrounding our segments and product related constant currency revenue growth drivers. Vascular North America, third quarter America revenue increased 3% to $85.1 million. The increase in vascular revenue was largely due to sales of Vidacare EZ-IO and OnControl devices. As well as increase pick sales which incidentally grew by double-digits. Moving to anesthesia North America, third quarter revenue was $48.7 million, up 2.2% versus the prior-year period. Growth in this segment was driven by increased sales of Vidacare EZ-IO, area management devices, epidural kits, and itemization products. This was somewhat offset by year-over-year declines in regional anesthesia and laryngeal product offerings. As a sign the Vidacare product lines continued to perform well, growing approximately 20% globally on a constant currency basis this quarter. The performance in Q3 was within our expectations, and we continue to expect global Vidacare product lines to deliver approximately 20% growth for the full year. Turning to our surgical North America business. It’s revenue increased 5.7% to $41.9 million. The increases in surgical is primarily attributable to higher sales of access ports and surgical instruments. Chest range products also grew due to continued competitor issues. Shifting to our overseas businesses, EMEA revenues continue to rebound in the third quarter, and expand that 2.2% on a constant currency basis totaling $121.4 million. The improvement in European revenue was largely the result of increased urology and surgical product sales. This was somewhat offset by lower sales of carrier product as our European business continues to work through at backorder in this product category. We have now seen sequential improvement in Europe from negative 1.9% in quarter one, to positive 1.3% in quarter two, and now positive 2.2% in quarter three. Moving to Asia, the third-quarter revenue increased 2.1% to $64 million. The quarterly increase in Asia revenue is primarily due to higher surgical ligation and anesthesia sales The Asia result was below expectation, and was driven primarily by weakness in Southeast Asia and Australia. We expect Southeast Asia to recover in quarter four, and have good line of sight of distributor orders driving this recovery. On a positive note, China growth exceeded 8% in the quarter. We expect a recovery in Asia growth in quarter four as the anniversary some one-time events in the region. This is despite the tough comparable in China in quarter four. Turning to OEM, during the third quarter revenues increased 6.3% to $41.4 million, and was primarily due to higher sales of performance fiber products. Lastly, third-quarter revenue for the businesses within our all other category was up 2.8% totaling $53.1 million. Growth here is primarily attributable to sales of additional respiratory therapy, and North American based carry of intra aortic balloon products. This was somewhat offset by year-over-year revenue decline in our Latin America business. Next, I would like to briefly update you on additional GPO and IDN agreements that we received during the quarter as well as some recently received regulatory approvals During the third quarter we won 15 year agreements and extended another 10. Of the agreements won and extended in quarter three, 16 were solo source in nature. Approximately half of the solo source awards protect our existing business. While the other half position the company to expand their sales across a variety of clinical areas, including our percutaneous product line, [indiscernible], pain pumps, dialysis catheters, closure devices, PICCs, vascular positioning confirmation systems, and Vidacare OnControl. Moving next to regulatory approvals, I am pleased to report that in August we launched a new second-generation Percuvance System in the United States. We had already launched the second-generation device in the second quarter outside of the United States. This second-generation device is more versatile than its predecessor and features additional interchangeable 5 mm tool tips. As well as a new quick connect system to facilitate fast and secure tool tip changes outside of the body. This product has the performance and versatility for use in common and advanced general laparascopic procedures, including laparascopic cholecystectomy, upper gastrointestinal, gastric, bariatric, colorectal, and hernia procedures. We remain very enthusiastic about this product opportunity as we see an increased adoption of the product -- as the product gets more approvals from fact committees in the United States. In the addition to Percuvance we also received five 10K clearance from the FDA to market our Arrow Jacc with Chlorag+ard technology, and tight track tumbler. This device is a long-term tunnel small french size antithrombogenic and antimicrobial central venous catheter designed for use with high-pressure injections. By providing an antithrombogenic and antimicrobial catheter to protect against catheter occlusion we are offering a technology that no one else can. This is important in patients with end-stage renal disease were best in house and preservation is essential to provide future dialysis vascular access. Another five 10K approval that was received from the FDA during quarter three was the Arrow midline product with Chlorag+ard technology. This is an anti-thrombogenic and antimicrobial PICC designed to minimize common midline catheter complications. Such as catheter intraluminal occlusion, thrombus accumulation, and microbial colonization on the catheter surface for a minimum of 30 days. Development of new technology to ensure that the patient receives the safest, most effective IV therapy possible should drive all medical device manufacturers. And it is our belief that this product helps to do so. The last new product that I would like to draw your attention to is the Arrow VPS Rhythm System. During the third quarter, we received CE certification to commercialize this device in the European Union. The Arrow VPS Rhythm System is a simple and flexible solution that helps the clinician to place the catheter by providing ECG base tip confirmation, and a highly portable, lightweight and versatile design. It assists in the placement and confirmation of the catheter tip, and maybe used for a broad range of catheter types. And it is our belief that this clearance puts us in a position to establish reliable, cost effective standard of care in catheter navigation and placement in Europe. Lastly I would like to update you on the status of our 2014 manufacturing footprint realignment plan. On our last earnings conference call I updated the investment community on a variety of our restructuring plans. That included our 2014, 2015, and 2016 restructuring initiatives. Today, I would like to provide you with a further update specifically regarding the 2014 plan. As a reminder the 2014 plan was announced in April 2014. And it involves the consolidation of operation, and related reduction in workforce at certain facilities, and the relocation of manufacturing operations from certain higher cost locations to existing lower cost locations. These actions commenced in the second quarter 2014, and were originally expected to be substantially complete by the end of 2017. Today we have completed the consolidation and relocation of a significant portion of the operation. I would estimate that we would achieve annualized savings of approximately $17 million by the end of 2016 directly related to these actions. With respect to the remaining actions to be taken under the plan, we revised are savings expense and timing estimates during the third quarter to reflect the impact of changes that we have implemented with respect to medication delivery devices including certain of the kits sold by our vascular and anesthesia businesses. As a result of these changes, we have reduced our estimate with respect to the overall annualized savings we expect to realize under the plan, from our prior estimate of $28 million to $35 million to a range of $23 million to $27 million. We anticipate that the changes that we have made to our vascular kits will enable us to realize improved pricing on those kits, which in turn we expect will result in increased annual revenues that should offset a significant portion of the decrease in projected plan savings. As a result, we anticipate that this projected increase in annual revenue, taken together with the projected annualized savings we expect to realize under the plan, should enable us to improve our pretax income on an annualized basis by approximately $28 million to $33 million once the plan is completed or substantially similar to our original estimation. However, as a result of the changes, the 2014 manufacturing footprint realignment plan will not be substantially complete until the first half of 2020. As we previously stated these are complex projects, and the potential risk to these restructuring programs has been the timing of the execution. We continue to evaluate alternative measures to mitigate the reduction in savings and accelerate the timetable for completion. We will update you as this information becomes available. Despite this change, I would like to emphasize that Teleflex remains on track to achieve that 350 to 400 basis points of both adjusted gross and operating margin expansion by 2018 that we previously discussed with the investment community. That takes me to the end of my prepared remarks. At this time I would like to turn the call over to Tom for him to review our financial results for the third order and to provide our updated full-year 2016 guidance. Tom.
Thomas Powell:
Thanks Liam and good morning everyone. Given the previous discussion of the Company’s revenue growth drivers, I will cover results below the revenue line where we have a very compelling financial story for both the third-quarter and year-to-date results. For the quarter, adjusted gross profit was 245.8 million versus 230.5 million in the prior-year quarter. And the adjusted gross margin increased 200 basis points to 54%. The increase in gross margin reflects the impact of lower manufacturing costs, the impact of favorable fluctuation to the foreign currency exchange rates, and the impact of price increases primarily in the Asia, vascular North America, and surgical North America segments. Also during the third quarter adjusted operating margin increased 250 basis points to 23.7%. The increase was largely the outcome of the gross margin gain, control over discretionary overhead spending, and the impact of the suspension of the medical device excise tax. Improvements were somewhat offset by increase in R&D Investment. Adjusted net interest expense increased to approximately 11.7 million versus approximately 10.8 million in the prior-year quarter. The increase and adjusted interest expense is the outcome of the May 2016 issuance of 10 year 4 7/8 senior unsecured notes, with a proceeds of the issuance being used to redeem a portion of the 3 7/8 in veritable senior subordinated notes, and reduced borrowing under the revolving credit facility. The net results being a modest increase the average interest rate on outstanding borrowing. The interest rate was partially offset by the third quarterly payment of 50 million of revolver borrowings of cash available on the balance sheet. In the third quarter the adjusted tax rate was 14.2%, which was up 90 basis points versus the prior-year period, while a favorable to internal expectations. Largely result in a shift in income to a more favorable tax jurisdiction. On the bottom line, third-quarter adjusted earnings per share increased 12.5% to $1.80. We are pleased with both progress we have made to expand our growth and operating margins and to drive meaningful gains and earnings. Q3 adds another quarter to our year to date track record of generating substantial financial leverage for revenue growth in the lower, mid-single digits. This progress is perhaps best evidenced by a quick review of year-to-day performance. When nine months ended our reported increased revenue 2.2%. Our adjusted gross profit increased by 6.1%. Our adjusted operating profit increased by 17.5%, and our adjusted EPS increased by 20.6%. In addition, for the first nine months our adjusted gross margin increased by 200 basis point in our adjusted operating margin increased by 310 basis points versus the prior year. So, despite softer than plan revenue growth, we have been able to drive very positive financial results in the margin expansion and earnings growth story remains very much intact. Robust earnings growth has also translated into meaningful cash flow generation. For the third quarter, cash flow from operations increased 79% to $120 million. On a year-to-date basis cash flow from operations increased 71% to $302 million. The year-to-date increase was primarily the outcome of improved operating results, a net favorable impact for changes in the working capital items, and reduction in income tax payments. From a balance sheet standpoint at the end of the third quarter cash on hand totaled approximately $500 million. Leverage as per our credit facility definition was at approximately two times. Combining our strong cash flow generation with balance sheet capacity we’re well-positioned to capitalize on strategic opportunities. Finally during the third quarter we announced an additional restructuring program designed to further improve operating efficiencies and to reduce cost. These actions include the consolidation of select administrative functions and manufacturing operations. Through this program we expect to achieve NOI pre-tax savings of between $4.5 million and $5.5 million once the program is fully implemented in early 2018. That completes my comments on the third quarter results. Next they will provide an update to full year 2016 financial guidance. Starting with revenue, as covered earlier for 2016 we are lowering our full year as reported in constant currency revenue growth guidance to reflect our current expectations. We now project full year as reported revenue growth to be between 2.4% and 2.8%, and we project constant currency growth to be between 3.4% and 3.8% versus 2015 levels. Turning to margins, we are reaffirming our previously provided adjusted gross and operating margin guidance ranges of 54% to 55% and 24% to 24.5% respectively. Based on our year-to-date adjusted tax rate of 18% and projections for the fourth quarter, we now expect full year adjusted tax rate to be between 17 3/4% and 18 1/4%. This compares to our prior range that calls for an adjusted tax rate of between 18.5% and 19.5%. On the bottom-line we are increasing our full year adjusted earnings performance share guidance range and now expect adjusted EPS to be between $7.25 and $7.34. This represents growth of 14.5% to 16% versus 2015. Additionally, we now expect cash flow from operations to be in the range of $400 million versus our original expectation of $330 million. This raised EPS marks the third consecutive raise this year and signifies our commitment to deliver meaningful earnings accretion regardless of the revenue environment. This is clear affirmation to Teleflex’s capability to generate non-revenue dependent earnings growth and cash flow generation. And that concludes my prepared remarks. At this time I would like to turn the call back over to the operator for questions. Operator?
Operator:
Thank you. [Operator Instructions]. And our first question comes from the line of Larry Keusch with Raymond James. Your line is now open.
Larry Keusch:
I just wanted to -- I know you had touched on some of these aspects here, with your constant currency guidance for the year, I guess at the midpoint around 3.6%, how do you think about the 5 to 6 that was outlined in the long-range plan? And if you still believe that you are in that range, what sort of accelerate you from where we are today, because obviously you have been struggling a little bit with the top line?
Benson Smith:
I will let Liam answer that and I will give you my own color, Larry.
Liam Kelly:
Hey Larry, It’s Liam here, we still feel pretty confident in the longer term of 5% to 6%, and what that is based on predominantly is in our Outlook for in particular the North American market. What I would like to point out is that we while our North American business units reported save 3.6% in quarter 3, we have really good visibility on tracing out direct customer sales. That would indicate that our actual sell through to hospitals, which for us is the more critical point is the uses of our product in hospitals, in North America during the third quarter was in the high 5%s from a percentage. So we do not think that the third quarter truly reflects what our business is capable of doing. And we see this is a good indicator of actual demand for Teleflex products. We have also seen a nice recovery in EMEA to achieve over 2% growth in the quarter so we have seen acceleration there. We have also seen Asia starting to recover in next year, to sort of bridge the 5% to 6% in the longer term. So broadly speaking North America would drive increased revenue growth, a modest recovery in EMEA for those singles, and getting Asia in particular up into the high single-digit category should get us there, Larry.
Benson Smith:
So I think, Larry, we started to get a lot more comfortable when we started to peel a couple layers of the onion away, and get through what was going on at the distributor level, and look what was going on at the hospital level. By way of comparison, getting back to the flu, there was essentially no flu in terms of the first quarter this year, in terms of seriously ill patients being in the hospital. Which was the case in the prior-year, and intact for the prior four years. And in spite of that, our sales through the hospital are showing really good growth. So, that is a little bit of a masquerading event that is occurring there. And once we get through that and also see the trend in new products we are a lot more comfortable after we understood that them before we started to do the analysis.
Larry Keusch:
Okay. That is helpful. So, two other quick ones for you, first again just coming back to the 3.6% midpoint in the range constant currency that you are now looking for in 2016 and listening to the Liam’s comments that certainly believe that 5 to 6 is doable and it sounds like perhaps in the latter portion of the LRP. Are you prepared or can you say today whether you think that 2017 sales can accelerate from that 3.6 at the midpoint of the rang. Then, the second question is just any thoughts that either Liam, Benson, or Tom may have as it relates to M&A and the outlook there?
Benson Smith:
So, we are obviously in the midst of doing are 2017 plan at this point. I think again some encouraging signs for us is largely on the fact that there was not a flu season this year so that comparable in the U.S. is going to be help all. The trend of growth in the U.S. is about a full percentage point higher on a hospital basis for year-to-date so far compared to last year, so that trend is continuing and we expect to see that continue. I think with additional stabilization in Europe that’s going to be helpful. And most of these shortcomings in the oil countries and pan Asian market will be completely out of our history and comparables. So I would certainly expect to see an improvement from 3.6%. Yes.
Liam Kelly:
Now just to reinforce that we have seen a pickup in new products particularly in our key North American market from 1.2% in Q1 to 2.2% in Q3. So we anticipate having a more robust new product and it gets to the fact committee. We found, Larry that it is taking six to nine months to get through these fact committees. So therefore it causes a little bit of a lag between launching these products and getting the revenue recognition for them. Which we have not fully anticipate.
Benson Smith:
To the 2017 question if you could repeat that.
Larry Keusch:
Again it is just your thoughts on the M&A Outlook.
Benson Smith:
We continued to evaluate a lot of opportunities that our M&A group continues to be quite busy. We remain disciplined about what we are interested in looking at. And it basically has to meet that criteria in reaching our portfolio in terms of the essential necessity of the product, limited competition, and good growth opportunities in markets which we think are dependable and sustainable. So we are not concerned about our longer-range opportunity for M&A contribute to our growth.
Operator:
And our next question comes from Brooks West with Piper Jaffray. Your line is now open.
Brooks West:
Good morning. Liam, I missed your comments on the new product contribution, and I was wondering if you could just run through highlights again there? And I am curious as you do that if you could call out any surprises positive or negative as you start to get these new products into hospitals.
Liam Kelly:
Our overall new product revenue quarter three was 1.3%. The comments I was making about North American new product adoption was that we saw an uptick in new product adoption in our key North American markets. Going from 1.2% in Q1, to 1.6% in Q2, to 2.2% in Q3. So Brooks my comments was that even though products have now got through the value analysis committee the signs are positive that in our key North American markets we’re beginning to see traction. And what the value analysis committees have called is a delay in the products getting through to the hospitals. And I will just give you a little bit more anecdotal of a positive outcome. Even though Percuvance itself is not going to drive significant revenue in 2016, I will start to climb through 2017. We see that we have approximately a 70% hit rate in Percuvance going through value analysis committees in getting approval. So that’s a positive sign for us on Percuvance and on value analysis committees in general. But it does cause a lag in the six to nine months, Brooke.
Brooks West:
And as we look at 2017 just a follow-up on the previous questions, could you weight for us the factors that might push you higher or lower? Is it new product performance, is it geographic performance? Can you give us some framework for how to think about attached to the various contributors.
Liam Kelly:
Absolutely. We are quite bullish on our North American market which is a key market. I think as Benson said a number of times not all growth is equal. So growing in North America is a key part of our strategy. We see that in our tracings and our direct to customers that the North American market is actually growing faster than our reported numbers would indicate. And for us, Brooks, clearly the demand at the hospital level is consumption of our product and that is absolutely key to us. On a geographic standpoint we do require an uptick in our Asian market, and in particular Asian markets. So the up in Asian markets in particular, in China in particular, in India, and again more modestly within our Korean markets. And even within the quarter we saw that China grew by 8%, and India grew 9% in this current quarter on constant currency. We’re not expecting much acceleration in the EMEA but a modest acceleration in order to get to accelerated growth in 2017.
Operator:
Our next question comes from the line of Kristen Stewart with Deutsche Bank. Your line is now open.
Kristen Stewart:
I’m wondering if you could walk through I guess the reduced revenue expectations, but the maintaining of operating margins. Is it just you are being more selective on your products that you are selling or looking to focus more on the mix of the stage? And then secondarily as we look out over the next couple of years, with the push out of some of the savings from the 2014 plan, are there any opportunities for you to perhaps pull in savings from other plans or initiate other restructuring activities? Thanks.
Benson Smith:
I will have Tom start with the latter half of your question and I will jump in for the first half.
Thomas Powell:
Okay, so the first question was related to maintaining operating margins. So let me touch on that. As we think about the year-end guidance that we have provided, certainly we have got to call down to revenue. What we are seeing is a little more favorable FX than what we previously expected. So our reported revenue reduction is not as significant as the constant currency. But it is a reduction and that has impacted our gross margin modestly. What we have been able to do to hold operating margin is that we have some discretionary spending that we scaled back, and we have also really tightened down on all costs in the SG&A line. So we have been able to offset that modest reduction in gross margin as we get the operating margin. So, effectively what we are able to do is hold that margin at the same level despite the reduction in revenue. Now from an operating profit standpoint we are down a little bit due to the revenue call down, and we were able to offset that due to favorable tax rate and some favorability in our expectations for interest rate.
Benson Smith:
Just looking at mix, that had a lot to do with it Kristen, if you look at our 2.7% as reported gross and number, almost, a little over a third of that all comes from Vidacare where it’s growing at 20% and in of itself contributes 100 basis point of growth at 85% margins that is really, really helpful in terms of being able to mitigate loss of revenue in Latin America, for example, which is a much, much slower gross margin product. It gets back to really, I think reinforcing the quality of the revenue growth.
Liam Kelly:
You asked about our 2014 restructuring Kristen I just want to touch on that. So as we detailed the restructuring plan has been recast, as you say, from $28 million to $35 million to a new range of $23 million to $27 million. Now we do have an offset because the decision was to move to [indiscernible]. In doing that it does address some health care provider safety. And this added safety will allow us to take a modest price increase which will get the combined savings range to $28 million to $33 million. So we are pretty close to the original range. I think that we will continue to work and continue to update the investment community on mitigations, and we continue to look to improve that timeline. But, the information that we have in front of us at the moment is as accurate as we can provide to you today. Notwithstanding that we are in discussions with our operations people, and we are in discussions with outside vendors to assist us to improve the timeline and we will update you as that becomes available.
Thomas Powell:
I think there is also a question about whether we are able to perform in other plans to help offset. As we outlined the original guidance for gross margin expansion in 2018, part of it being a footprint consolidation project we are speaking about. We also mentioned that there were number of initiatives that were not included in that margin expansion. We didn’t include the benefits from M&A, we didn’t include any margin benefits from distributor conversions, or subsequent separate programs. As you are aware, since announcing the gross margin target we came out with a second initiative on footprint consolidation so that can be used as a potential late offset. In addition, today we’re talking about another restructuring program that’s going to benefit both in the SG&A line and in cost of goods. So essentially your question is we continue to look for new ways to drive costs down the system, and we feel very confident in our ability to get to that gross margin and operating margin target in 2018 as a result of the activities we’ve got going on.
Benson Smith:
And I would add to that when we initially introduced it, we said there was a good degree of conservatism in these numbers and I think that we still would will describe that goal as conservative today.
Kristen Stewart:
That’s helpful. Just to follow up for earnings, Tom what was currency as of last quarter, and what is currently now assumed in the 2016 guidance?
Thomas Powell:
In terms of a revenue impact are you looking for a total? Guide for the fourth quarter.
Benson Smith:
We’ve got at $109 million in the fourth quarter. As we think about the currency impact on revenue we assume it is a 1% impact on revenue, it is about neutral on the bottom-line.
Kristen Stewart:
So currency made no visible change on the EPS line?
Thomas Powell:
It’s a little bit more favorable than what we expected previously, possibly.
Operator:
Our next question comes from David Lewis with Morgan Stanley. Your line is now open.
David Lewis:
How are you, I want to focus on two issues this morning, one is cost in one is strategy. First is guys we talk in more detail on the nature of the push out, it is about three years. Is it quality driven? I am trying to understand what exactly would have driven the change. And then your confidence that you can get this back to pricing which is largely why you think the difference is going to be relatively small. Then, Tom, I am trying to quantify this for shareholders, to me it looks like that shift of sort of three years is around $17 million to $30 million of potential impact over that time period, which is about 100 to 200 basis points in margin. I’m sorry I know its specific questions, and I have a quick follow-up, but I wanted to dig deep on those three issues.
Liam Kelly:
David Let me talk about the cost first. It is a timing issue driven predominantly by a requirements to provide a vial versus ampoule which add a few knock on affects. One impact was a tray reconfiguration transpiration as you can imagine this is a complex project. This added an incremental time like in order to get this executed and delivered. With regard to what is driving the price increase, moving from an ampoule to a vial does address some significant, clinician safety concerns. When you break and ampoule you sometimes get some healthcare accidents that occur with that. We believe that the change is a mark improvement, and allows us to put in a modest price increase into our anesthesia and vascular kits. That is a component of the offset against the timing.
Thomas Powell:
We have had conversations with key customers. It’s simply a matter of when their existing contracts expire or renew in terms of when we can put that into effect and it has zero to do with quality.
David Lewis:
Tom just in terms of quantifying this for share holders, so this pushes out three years, just taking the numbers in the press release. We are getting $17 million to $30 million a potential shift just over that time frame, obviously not in the absolute number, and that is about 100 to 200 basis point in the margin over some 2 to 3 year period of time?
Thomas Powell:
Let me just clarify that point, as you look at it, previously we expected to be substantially complete with the program by 2018. And so as you know our expected savings were between 28 million and 35 million. Now, by 2018 we expect to be about two-thirds of the way complete, so it’s more, it gets 2018 the way that we should be thinking about it is a 50 basis point reduction in our 2018 margin not 120 basis points. Effectively were at 16 million by the end of this year. We will deliver more savings by the time we get to 2018, and the way that you should think about it is about a 50 basis point reduction as a result of this push out.
Benson Smith:
I would say, David, also that we have a constant stream of opportunities that we are evaluating that has a positive impact on our margins. I think that it would be -- I’m not sure the right approach would be to simply do the arithmetic and say they are overall more [indiscernible] goals will be reduced.
David Lewis:
That is very helpful. Thank you for the clarification. I guess the second thing is that you spent a lot of time in your prepared remarks talking about the strategy for Teleflex, and what I took away from your commentary was you are not comfortable with your reliance on ex-U.S. products. It sounded like to me you would like a business that is more U.S. centric, and you may have to reinvest at a higher rate to sort of drive some of that acceleration. Am I hearing you right, in sort of that preamble, and I’m wondering as it relates to the M&A discussions if you want to shift your business to a U.S. focus in light of your current organic growth rate and some of the margin things we talked about in this call. Is this actually the right time to pursue more significant M&A? Some commentary on strategic question so the investors are clear on what you are trying to impart. Thank you.
Thomas Powell:
I do think that the location of acquired revenue is more important to us and having good growth potential in the U.S., rather than having exhausted their growth in the U.S. and having to depend on foreign growth as a way to sustain their growth rate, is figuring more into our calculation about what makes a good investment for us. You are correct that over time we want to become more centered around the U.S. for the reasons that we described in our strategy. And again going back to 2015, looking at a $0.87 headwind, and as a result of currency fluctuations just in Europe, was a point that we realized we do not want to be in that or have that same degree of vulnerability as we look down the road. So it is part of our strategy in trying to be more U.S. centric, and that is going to make us look a lot more like other U.S. medical device companies as well.
Operator:
Our next question comes from the line of Richard Newitter with Leerink. Your line is now open.
Unidentified Analyst :
Hi. This is Robbie in for Rich. Can you hear me okay?
Jake Elguicze:
Yes.
Unidentified Analyst:
Thank you for taking the questions. Just maybe a follow-up on the U.S. strategy. Given the distributer commentary that you made where your sell through is relatively higher than your sell in and the focus on the U.S. business, is that suggesting there is an opportunity in M&A for more distributor acquisitions in this area? Should we think about the M&A strategy as it progresses this will be a focus? Then I have a couple of follow-ups.
Liam Kelly:
So Robby, when we talk about distributor delaying we are really talking about a different kind of distributor. We’re talking about distributors overseas that distribute our products. So they buy products from Teleflex, they have a sales organization, and they sell that through to the end market. The distributors in North America, distribution help for more of a better way of putting it they’re the [indiscernible] of this world, that would not be part of our strategy to go into the distribution and of the business in North America.
Unidentified Analyst:
Okay, then maybe put another way, is there other elements in your control in that area where you can sort of maximize the sell in to sort of better match the sell through?
Thomas Powell:
Probably not. I would say that now that we sort of understand this phenomenon, and are quite comfortable that it is not driven by losing share are losing count at a hospital level, I think we will do a better job of understanding the impact a little earlier. Bear in mind that essentially the flu season, except for this year, has been relatively normalized going back the last three years before. So this is the first year it’s really had much of an impact in the fact that the flu didn’t show up. So dealers went into the year with inventory in certain items prepared for the flu season and then that inventory has to be bled out. Now we have to understand and have a full appreciation of it we are feeling more comfortable about it. It does not affect every product and it does not affect every company the same way. We only have a few products that are really affected. It happens to be some anesthesia products and vascular access products. But now that we understand we are less alarmed. Eventually, dealer inventories catch up with hospital demand. So we do not see this as a long-term strategic issue.
Unidentified Analyst:
Got it. And maybe one more follow-up, on the new products in Vidacare, number one can you give us an update on how that shoulder access project is progressing, and what your expectations still are for Vidacare revenues for the year? And then secondly the value access committee commentary that you put out, you expect a little bit more impact I guess later you have noted around Percuvance into 2017 and more in 2018, do these longer discussions for value access committees affect the timing of any of that revenue or that is kind of baked into your assumptions still?
Liam Kelly:
I will deal with Vidacare product, the first sold, in our prepared remarks Vidacare in the quarter grew by 20% in line with our expectations. We see our full-year growth to be in that 20% range. As you know this is a very high margin project and one that drives a lot of value in our mix for Teleflex and it is part of the reason that even with a softer sales line that we do not have the operating incoming impact that one would expect from that. Dealing with new products and the value analysis committee, yes, it has reformed our thinking as to the timing of new products, once we launch them and they enter into our sales force. We now see a lag, as I said in my prepared remarks, of about six to nine months before the product comes through. I do want to quantify that though with our hit rate and I used the example of Percuvance as a product that we’re working through value analysis committees at the moment. Our hit rate on Percuvance is in the 80% of value analysis committee that we present to that we get approval., So it is a 70% approval weight to the value analysis committee. So we are quite confident that once we get to the value analysis committee we get through, but it does take a six to nine months for that to happen. So we have revised our thinking on our new product revenue to stage it a little bit, the acceleration of growth in new products to stage it a little bit later with that 6 to 9 month window there.
Thomas Powell:
Over time we will just have more data to present the them. Right now we have no real actual hospital experience to show them how these cost improvements work. As we collect more and more of that information the package we are able to present to these value analysis committee’s increases, and there are other hospitals that we can point them to that have actual asked variance with it.
Operator:
Our next question comes from Anthony Petrone with Jefferies. Your line is now open.
Anthony Petrone:
I have a couple of questions on general procedural volumes and I will follow up with one’s specifically on PICC asked. Maybe Liam or Benson, can you comment just high level that what you are seeing in procedure volume, and really it gets to the mixed reads that we’re getting from hospitals in the Q2, Q3 time frame, even last night Community Health reported, AGA is out there today looks like AGA is a little bit better and Community Health is worse. What do you see there in procedure volumes? And then a follow-up to that would be just as you look forward to healthcare exchange enrollments. If that does shift, if premiums go up, deductibles go higher, how do you think that impact volumes in 2017?
Thomas Powell:
So our best take on this right now is that there is a continued increase in the acuity level of patients at the hospital. So, we’re not seeing a slowdown in U.S. hospitals relative to our product portfolio. In terms of the impact of the Affordable Care Act, our take on this is that the population that is in the Affordable Care Act already were [indiscernible] cases with high deductibles that were preventing them or delaying them from going to see a doctor et cetera. And we are kind of through that point were really sick patients have go any way. So we think it is going to have an impact, a potential impact on providers potentially, we do not see an impact on our own product line. And, again, we are seeing good growth across our product lines in terms of U.S. vascular utilizations through the year and has been increasing every quarter.
Anthony Petrone:
That’s helpful. And then maybe to shift to PICCs, your competitor reported a couple days ago they spoke of gains in the category there, through some new products and acquisitions. And I am just wondering if you are seeing any impact in your business specifically within PICCs? And your competitor also speaks about an OUS opportunity in PICCs specifically in emerging markets. Is there sort of a push from Teleflex to also move PICCs into emerging markets? Thanks.
Liam Kelly:
Okay. I’ll take that one. So our PICC growth, as I said in my prepared remarks in North America was double-digit. So over 10% growth in North American markets. Which is the largest PICC market in the world. We are in the process of registering our PICC product globally. We do not have a pressure injectable PICC with coding technology registered in the Chinese market. Our competitor may be growing overseas, but for sure our share gains in North America demonstrates was that double-digit growth in our PICC market. And that is the largest PICC market. So we are very comfortable with the growth and share gains we are taking in the key North American market.
Anthony Petrone:
That is helpful, and then just timing on entering China with your PICCs. Thank you.
Liam Kelly:
We have a filing submitted.
Operator:
And our next question comes from Matt Mishan with KeyBanc. Your line is now open.
Matt Mishan:
When I heard your comments about focusing on the U.S. and growing there, and maybe reducing your exposure to emerging markets and into Europe, the first thing that struck my mind was that our divestiture back on the table? And in particular I think the cardiac business you have called out before as being potentially non-core, can you size that business for us right now? What percentage of that is OUS and Europe versus U.S.? And where are the margins in that business versus company average?
Thomas Powell:
So the margins are about at current target levels. The business is around $80 million as a global business. It is growing at a rate that we are quite satisfied with, and there is only one other competitor in that market space. So, I think that it has been on a healthy trend for the last year and that has increased our interest in not just maintaining the business but in growing the business and we’re seeing good growth out of it.
Liam Kelly:
I would just add on the cardiac business, we have a reasonably robust new product pipeline coming through that we believe is going to accelerate the growth within cardiac. It is creative to our overall growth on the top line, but you are right, Matt, more of the business overseas than in North America. But notwithstanding that, it is as Benson said a duopoly. There is one other player in that market space. So it is still quite attractive to us.
Matt Mishan:
And then, just a little more color on the changes on the impact of the restructuring actions. I think you previously were calculating the 28 million to 35 million conservatively, and you did it on static volumes. Am I thinking about that right? And have you updated the numbers based upon your current volumes today, or the expected volumes? And maybe the magnitude of the change is a little bit greater?
Liam Kelly:
I would say that we have made no changes to the way that we calculate savings on the restructuring. We have been consistent in the way that we calculate that.
Thomas Powell:
We want to present the ranges exactly the same way they were calculated initially. But if your point is how volumes been going up associated with those product lines the answer is yes. So there is some conservatism in that as a result.
Operator:
Our next question comes from Brian Weinstein with William Blair. Your line is now open.
Brian Weinstein:
I just wanted to go back to the flu commentary a little bit, we heard the same thing last night out of Quidel given the surrounding D distribution situation there. But how do you guys specifically quantify flu, what specific products, you mentioned anesthesia and vascular aspects, have you specifically quantify you impact of flu? What is your general dollar amount that you are exposed to there? And then also on that topic, if we didn’t see seriously ill patients in the hospital in 1Q as a result of the flu season, why was this something that was kind of not already previously contemplated that this might be an area where you could potentially see a shortfall?
Liam Kelly:
The product categories that are impacted by the flu season are in our vascular portfolio. Our central venous catheters are impacted. Within our anesthesia portfolio you have laryngeal mass, and to tracheal tubes and those. And in our respiratory portfolio the humidification part of that portfolio, those are the three. For example Brian our surgical portfolio has zero impact on a strong or weak flu season, and similar to our cardiac portfolio. How do we measure the impact? We look at trends as to what happens in prior years. So, last quarter 3, a lot of the distributors bought in quarter three in anticipation of the flu season. And that simply did not happen in this quarter. We saw a pickup last year in North America in quarter 4, and it normally comes in late November into December in quarter 4. We anticipate at the top end of our range that same phenomenon. We have spoken to our large distributors, they told us to expect the exact same phenomenon. They purchase on the basis of a normalized flu season. If the flu season is more aggressive and the vaccine does not work as well we have seen a positive. As last year’s flu season was anemic we see a slight negative.
Benson Smith:
I think your question is a good one and part of the answer is that, since I have been here, flu seasons have been pretty much similar from year-to-year. And in many cases I would have not anticipated, for example, personally I would’ve not anticipated CDC catheters were a big product use during the flu. It only affects two product lines and only a few of those really severe patients. So this experience this year having basically no fleas reason, it took us a while to catch on to it. But now I think we have a pretty clear line of sight around it.
Operator:
[Operator Instructions] And our next question comes from Matt Taylor with Barclays. Your line is now open.
Matt Taylor:
So I want to circle back to some of the commentary that you made about revenue progression given the softness of the quarter. You talk about perhaps getting some acceleration in different geographies going forward. But recently you also talked about lack of visibility in some of those areas. I guess, can you just give us some level of confidence on the specific plans that you have internationally? Specifically where have seen weakness to kind of draw out better growth rate and achieve the mid-single-digit growth rate that you have been aspiring to more consistently?
Benson Smith:
Let me address the visibility question and I will turn it over to Liam. My commentary about visibility is the unpredictable nature now of the flu season, and not a lot of visibility in terms of exactly when viewers are going to put stock up for it. and it’s not a matter of asking the distributor what you are going to do these are decisions made at local distribution units not nationally. There are 40 different partner locations that will make decision on what inventory they will pull in. Aside from that we have excellent visibility. Asia for example, we pretty much have all orders in-house that we are going to ship out the fourth quarter, and Liam can go over a little more about the trends there.
Liam Kelly:
First I will talk about this first quarter Matt and I will give you a bit of the longer term. So first of all in the fourth quarter we went have one extra billing day. And Benson was alluding to a good line of sight in two parts of our business that contributed to that acceleration, AIPAC and OEM. At this stage for a distributor model in AIPAC we would have all of the orders booked, as Benson was saying. We have seen a nice uptick in EMEA through Q1, Q2, and Q3. And we expect that to continue into Q4. And then longer-term, we had a few one-time events in Asia, that we have anniversaries, some product registration issues, and in particular in China, around the double [indiscernible] tubes and unique laryngeal mask that are now back in the market. So that would help accelerate those markets. And our growth in China, even in the quarter was 8%. India is another market with personal growth of 9% in the quarter. We are quite selective in the markets that we want to grow in Asia, but we see those driving, Asia, beyond the performance that we have seen the year-to-date. We see EMEA and low-single-digits, Japan and Australia in that same bracket. But, we also are quite encouraged by the tracings and end customer demand that we see in North America. And we see that predominantly driving a lot of our sales growth in the future.
Matt Taylor:
And then just one follow-up, you are into some new relatively good product cycles. You’ve got Vidacare, the protector, and now Percuvance. Can you speak in broad strokes about whether you expected new product growth of next year in 2018 to be more or less for the same that we saw here in ‘16?
Liam Kelly:
We have not given our 2017 guidance. But given the number of new products that we have coming through our portfolio, and now that we have a better handle on what happens in the value committee, we would expect a pick up new product revenues in the years to come for sure. And we will address that when we give our 2017 guidance.
Benson Smith:
But Vidacare is an example, is not a product that would be included in our new product numbers. Even though it is relatively new to us so that number is outside of our new product estimate.
Operator:
That is all of the time that we have for questions. I would now like to turn the call back over to Mr. Jake Elguicze for closing remarks.
Jake Elguicze:
Thanks operator and thanks everyone for joining us today on the call. This concludes the Teleflex Inc. third-quarter 2016 earnings conference call.
Operator:
Ladies and gentlemen, thank you for participating in today’s conference. This does conclude today’s program you may now disconnect. Everyone have a great day.
Executives:
Jake Elguicze - Treasurer and Vice President of Investor Relations Benson Smith - Chairman and Chief Executive Officer Liam Kelly - President and Chief Operating Officer Thomas Powell - Executive Vice President and Chief Financial Officer
Analysts:
Larry Keusch - Raymond James Kristen Stewart - Deutsche Bank Dave Turkaly - JMP Securities Scott Wang - Morgan Stanley Anthony Petrone - Jefferies Ravi Misra - Leerink Partners Matt Mishan - KeyBanc
Operator:
Good day, ladies and gentlemen, and welcome to the Teleflex Incorporated Second Quarter 2016 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question and answer and instructions will follow at that time [Operator Instructions] As a reminder, this conference is being recorded. I would like to turn the call over to Jake Elguicze, Treasurer and Vice President of Investor Relations. Sir, you may begin.
Jake Elguicze:
Thanks operator and good morning, everyone and welcome to the Teleflex Incorporated second quarter 2016 earnings conference call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing 855-859-2056, or for international calls, 404-537-3406 pass code 47983139. Participating on today’s call are Benson Smith, Chairman and Chief Executive Officer; Liam Kelly, President and Chief Operating Officer and Thomas Powell, Executive Vice President and Chief Financial Officer. Benson, Liam, and Tom will make some brief prepared remarks, and then we’ll open up the call to Q&A. Before we begin, I would like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties and actual events or results may differ materially. The factors that cause actual results or events to differ materially include, but are not limited to, factors made in our press release today, as well as our filing with the SEC, including our Form 10-K, which can be accessed on our website. With that said, I would like to now turn the call over to Benson.
Benson Smith:
Thanks, Jake and good morning, everyone. It's a pleasure to be here once again to discuss Teleflex's performance and as an overview I must say we are very pleased with our results because they leave us well positioned to achieve our 2016 goals, but perhaps more importantly put us ahead of schedule in terms of meeting the longer-term goals outlined at our analyst meeting. Our strategy of focusing on higher margin, differentiated products in geographies we think will benefit most from demographic trends is already showing dividends. I'm sure you recall, that when we initially provided our 2016 financial guidance, we told you that we expected a sequential improvement in constant currency revenue growth rates, adjusted gross and operating margins and adjusted earnings per share as we move throughout the year. And I’m pleased to report that is exactly what happened from Q1 to Q2. In fact, the operating performance of the company in the second quarter continue to exceed our internal expectations in nearly every area allowing us to raise our full-year 2016 adjusted earnings per share guidance for the second straight quarter. Constant currency revenue growth reached 5% and we believe this position the company to achieve our previously provided full-year guidance range. During the quarter we generated constant currency revenue within each of our order book segments led by our higher margin vascular anesthesia and surgical North American franchises. And as we move through the remainder of the year, we fully expect constant revenue growth rates to continue to sequentially accelerate in Q3 and Q4 being led primarily by continued strength in the U.S. market. Because of our margin goal, strategically for Teleflex it is really important that we put all the right products in the right geographies. What and where we grow, but this is important to us as how fast we grow. Not all revenue for us is equal. For example, we have to have approximately $3 million of revenue growth in low-end respiratory therapy products to generate similar levels of gross profit equal to $1 million worth of Vidacare product growth. Our vascular access catheters were another example. These products will be the primary beneficiary of our first phase footprint consolidation effort. However, being conservative we calculated the savings at static volumes and when we provided our longer-term targets. So growth in these product categories means we will realize even greater savings down the line and result in a better mix. Speaking about margins, we reached adjusted gross margins and operating margins of 55% and 25.2% respectively. Both of which represent all time margin highs for Teleflex as a pure play medical device company. And despite of being the summer months, I have always said that we are not going to pull up the lawn chairs once we attain these levels of margins and that still holds true as we see an opportunity for continued significant margin expansion in front of us. Overall, I’m delighted with the company's results during the first six months of 2016 and I expect even stronger showing in the second year half. That completes my prepared remarks. I would like now to turn the call over to Liam. Liam will go into more detail around second quarter revenue and discuss the drivers we expect to accelerate revenue growth in Q3 and Q4. Liam?
Liam Kelly:
Thank you, Benson and good morning, everyone. For the consolidated company, second quarter 2016 constant revenues grew 5%. The primary driver of revenue growth this quarter came from increased sales volumes of core products, which contributed approximately 3.5%. This was aided by the fact that we have one additional shipping day in the quarter. This quarter is a bit unique, given that our financial quarter ended four billing days before the calendar end of the quarter. As such, it is difficult to quantify the exact impact of the extra day, but we estimate that it contributed approximately 1% of revenue growth. North America had a strong quarter with constant currency revenue growth of 8% of this core product volume growth improved by approximately 5.5% as compared to the year ago period. On the last call, I mentioned that sales into our distributors in the United States were less than the sales trading out. This situation improved slightly in quarter two with the remaining debt expected to equalize during the remainder of the year. We also saw good volume growth out of our OEM business. And while still delivering positive core volume growth during the quarter, our Asia business experienced lower growth than we initially anticipated as that business is working through a back order situation associated with our cardiac intra-aortic catheter business as well as some weakness in Southeast Asia. We expect to be reconstitute back order situation by the end of the third quarter. Another driver of revenue growth in the quarter is the result of an increase in our sales volume of new products which contributed approximately 1.3% of constant currency revenue growth. New product sales were particularly strong within our surgical, OEM and anesthesia businesses. Surgical and new product sales were driven by increased utilization of products used in robotic procedures. Further penetration of our EFX offering as well as an increase in the amount of Mini-Lap product sales. OEM new product sales are attributed to increase Force Fiber and coated catheter sales while in anesthesia the growth is primarily due to increase sales of our Rusch disposable LED laryngoscopes. And while not yet a key contributor in terms of revenue dollars, I would like to provide to with an update on the Percuvance product launch. On our last earnings call, I told you that we recently completed the first cases with our second generation device in Europe, where we are currently in full market release. Having received a CE mark in quarter one, the adoption of this second generation technology continues to progress nicely over fleet and we expect a slight uptick in OUS revenue contribution in the back half of 2016. While within the United States I explained on our last call that we received 510(k) approval on our second generation device from the FDA, but that there were some conditions associated with that approval. The 510(k) conditions require new sterilization study for reprocessing the reuse both Percuvance handle or into the latest FDA guidance. Execution as the protocol is currently underway and consistent with what I said in our previous earnings call, we continue to expect to have this completed in August of this year. This continued to position us for a full market launch of the second generation device in the United States during the third quarter. We continue to promote and demonstrate the first generation device in hospitals in the U.S. and the customer response continues to be overwhelmingly positive. We have completed 39 evaluations of the products and 32 are progressing through the value analysis committees. Turning to other components of revenue growth; during quarter two we saw the average selling price of our products expand approximately 20 basis points. This was primarily due to increase in vascular access and surgical products, as well as increases due to distributor conversions. This was somewhat offset by decline in European product pricing. Finally, during the second quarter previously completed acquisitions added approximately 10 basis points of growth. This was primarily due to the acquisition outstanding. Next, I would like to provide some additional color surrounding our segment and product related constant currency revenue growth drivers. Vascular North American second quarter revenues increased 8.8% to $88.2 million. The increase in vascular revenue was largely due to the sales of Vidacare, EZ-IO and OnControl devices. As well as increase intravenous catheter and PICC sales. Moving to Anesthesia North America; second quarter revenue was $49.2 million, up 8.2% versus the prior year period. Growth in this segment was driven by increased sales of Vidacare, EZ-IO, airway management devices, epidural kits and atomization product offerings. As an aside, the Vidacare product lines continue to perform well, growing approximately 30% globally on a constant currency basis this quarter. Turning to our Surgical North American business, its revenue increased 6.8% to $43.1 million. The increase within surgical is primarily attributable to higher sales like engagement products, surgical instruments and access boards. Chest drainage products are not strategically important also grew due to competitor issues. Shifting to our overseas businesses, EMEA revenues rebound in the second quarter and expanded 1.3% on a constant currency basis totaling $131.7 million. The improvement in European revenue was largely the result of increased vascular access and neurology product sales. This was somewhat offset by lower sales of cardiac product, as our European business has also been working through the same back order. Moving to Asia, our second quarter revenue increased 3.6% to $63.2 million. The quarterly increase in Asia revenue was primarily due to higher surgical litigation and respiratory sales. In addition, we continue to see good growth out of China, which during the quarter grew approximately 8% on a constant currency basis. Turning to OEM, you may recall from our quarter one earnings call that this business has some order purchase from quarter one, and as a result we expected to see an improvement in quarter two. Well, that is what happened during the second quarter constant currency revenue increased 5.9% to $40.3 million and was primarily due to higher sales and performance of fiber products. And lastly, second quarter revenue for our business is within our all other category was up 5.4% totaling $57.9 million. Growth here is primarily attributable to sales of additional respiratory therapy and cardiac intra-aortic balloon products. While our Latin America business made a recovery, generating modest constant currency revenue growth in the quarter. We do continue to experience difficult trading conditions in Brazil. Finally, before I turn the call over to Tom, I would like to briefly update you on additional GPO and IDN agreements that we received during the quarter, as well as the state of the several restructuring plans that are underway. During the second quarter, we have continued our track record of success with GPOs and IDNs, this time winning 19 year agreements and extending another nine. Of the agreements won and extended in quarter two, 16 were sole sourced in nature. In a few cases, the sole source awards protect our existing business. However, the majority of the sole and sourced awards received in the quarter positioned the Company to expand our sales across a variety of product lines including laryngoscopes, pain pumps, closure devices, arterial catheters, vascular positioning conformation systems, PICCs and Vidacare OnControl. This continued success of groups is another reason why we feel confident in our ability to achieve our full-year constant currency revenue growth guidance range. Lastly, let me update you on our most recently announced series of restructuring programs. I am pleased to report that our 2014, 2015 and 2016 programs remain on-track, both from a timing perspective and from an expected synergy generation standpoint. These programs are focused on improving both gross profits and reducing operating expenses. And they are expected to be substantially complete between 2017 and 2018. In total, these three programs are expected to drive between $55 million and $69 million of annualized pretax savings once fully implemented. We have started to see the early benefits from some of these initiatives, and we anticipate being significantly more over the next couple of years. That takes me to the end of my prepared remarks. At this time, I would like to turn the call over to Tom for him to review our financial results for the second quarter and provide our increased full-year 2016 guidance. Tom.
Thomas Powell:
Thanks, Liam, and good morning everyone. Given the previous discussion of Company’s revenue growth drivers, I’ll begin my prepared remarks for the gross profit lines. For the quarter, adjusted gross profit was $260.4 million versus $236.3 million the prior year quarter. The adjusted gross margin increased 270 basis points to 55%. The attainment of 55% gross margin exceeded our internal expectations and positions us well for the achievement of both our 2016 and multiyear gross margin targets. The 270 basis point gain in gross margin reflects the impact of reductions in manufacturing costs resulting from cost improvement initiatives including the 2014 manufacturing footprint realignment as well as the resolution of certain product quality issues that impacted the prior year period. Additionally, gross margin benefit from favorable mix, volume leverage and favorable year-over-year foreign exchange movements. Also during the second quarter, adjusted operating margin increased 480 basis points to 25.2% which is the highest operating achieved by Teleflex since becoming a pure play medical device company. The increase was largely the outcome of the gross margin gain, control over discretionary overhead spending, favorable foreign exchange movements and the impact of the suspension of medical device excise tax. The gains were somewhat offset by increase in R&D spending during the quarter. Continuing down the income statement. For the quarter, adjusted net interest expense decreased to approximately 10.3 million versus approximately 12.8 million in the prior year quarter. The decrease in interest expense is largely attributable to the June 2015 of refinancing of $250 million in principal amount of our six and 7/8 senior subordinated notes. To accomplish the refinancing we borrowed under our variable rate revolving credit facility, which bares an interest rate at a lower level than did our senior subordinated notes. Moving to taxes. In the second quarter, the adjusted tax rate was 20.6% up 110 basis points versus the prior year period. Despite being elevated within the quarter, we continue to anticipate that our full-year adjusted tax rate will be between 18.5% and 19.5%. On the bottom line, second quarter adjusted earnings per share increased by 33.1% to a $1.89. For the quarter Teleflex achieved strong financial leverage throughout the income statement. From reported top-line growth of 4.8% we generated a 10.2% in increased in adjusted gross profit of 29.1% increase in adjusted operating profit and 33.1% increase in adjusted earnings per share. The quarterly performance was dented by a breadth of non-revenue dependent productivity initiatives intended to deliver stable earnings and cash flow generation regardless of the revenue environment. Turning now to select cash flow and balance sheet highlights. On a year-to-date basis, cash flow from operations was approximately $181 million or increase of 66% or $72 million over the prior year period. The increase was primarily the outcome of improved operating results and net favorable impact from changes in working capital items and reduction in income tax payments. From a balance sheet standpoint, at the end of second quarter, cash on hand totaled approximately $476 million. Leverage as per our credit facility definition stood at approximately 2.2 times. That completes my comments on our second quarter results. Next, I would like to walk you through an update of recent capital structure activity. As discussed in our first quarter earnings conference call, pursuant to separate privately negotiated agreements between the company and certain holders of the convertible notes, in early April the company paid cash and issued common stock to note holders in exchange for $219.2 million of aggregate principal amount of convertible notes. We initially funded the cash portion of these exchanges through borrowings under our revolving credit facility. In May we completed the issuance of $400 million of 10 year senior unsecured notes which carry interest at a rate of 4 and 7/8. Proceeds were used to reduce the balance outstanding on the revolving credit facility. In addition, we also received conversion notices totaling $44.3 million in aggregate principal amount of the convertible notes and these conversions were completed in early June. We funded the cash portion of these conversions through borrowings under the revolving credit facility. Finally, subsequent to quarter end we repaid 50 million of revolver borrowings with available cash for the balance sheet. We are pleased with both the interest rates and the terms of the yield offerings and with the progress made to address the portion of the outstanding convertible notes in advance of the August 2017 absurdity. Next, I will turn to an update of full-year 2016 financial guidance. Starting with revenue; for 2016 we are reaffirming our full-year constant currency as reported revenue growth guidance ranges of 5% to 6%, and 3% to 4% respectively. We anticipate that our constant currency revenue growth rates will continue to accelerate as we continue through the year finishing with the particularly strong fourth quarter. As a reminder, we have one additional shipping day in the fourth quarter of 2016 as compared to prior year period. For the segment standpoint, we expect the strength we have seen in our first half of the year in our North American segments to continue through the second half, for our international and OEM businesses we are expecting acceleration of growth in the back half of the year. We are also reaffirming our previously provided adjusted gross margin guidance range of 54% to 55%, however we are raising our expectations regarding adjusted operating margin, which we now expect to be between 24% and 24.5% versus 23.5% and 24% previously. Based on Euros recent trading range and expectations for the balance of the year we now assume that the Euro to dollar exchange rate averages approximately $9 for the balance of the year, which is our previous assumption of approximately $6. On the bottom line, we are increasing our full-year adjusted earnings per share guidance range and now expect adjusted EPS to be between $7.20 to $7.32, which represents growth of 13.7% to 15.6% versus 2015. The increase in our EPS guidance range is due to a solid second quarter result, the expectation for continued strong operating performance in the second half, a modest improvement and our currency assumptions and also includes financial increase investment and support of the launch of new products. As a reference point the increase in our EPS guidance range is in-line with the over performance of sheets in the second quarter, as compared to our internal projection. In summary, we are pleased with the progress made today for the quarter we exceeded our internal expectations from margin expansion, earnings growth and cash flow generation. Our footprint consolidation initiatives are progressing largely on schedule, and we are excited for the prospectus of our new product line. Additionally, we took steps to address a portion of the convertible notes that were and were able to put it in place attractively price long-term financing. As an outcome we believe we are well positioned to achieve our longer-term financial and strategic objectives. And that concludes my prepared remarks. At this time, I'd like to turn the call back over to the operator for questions. Operator?
Operator:
Thank you. [Operator Instructions] And our first question will come from Larry Keusch of Raymond James. Your line is now open.
Larry Keusch:
Hi, good morning, everyone. I think probably the biggest question mark, post the Q2 results is, again, how you accelerate top-line to hit that 5% to 6% constant currency. And I know you have mentioned some areas that you believe will help you get there, the [one] (Ph) quarter, obviously the international OEM, you mentioned that accelerates, as well as in the second half. But I'm just wondering if you can dissect that a little bit more, and help us understand how you really get there?
Benson Smith:
So, first, I just want to remind everyone what we said that we expect sequential incremental improvement in constant currency growth rates throughout the year. And obviously that’s what we saw in this quarter. And this quarter is broadly in-line with our expectations. North America respond very well into the quarter with constant currency growth of 8%, which was up from 2.4% in the quarter. And OEM as you said, was also a strong driver. EMEA was 1.3, was slightly below our expectation, which was due to the cardiac sales. But we did see an acceleration at the backend of the quarter, which makes us feel that that’s actually continued throughout the remainder of the year and we are expecting recovery there. APAC was 3.6%, slightly below expectations Larry, but again driven by lower cardiac sales and some weakness in South Asia. If we look at the full-year we are confident in our guidance range of 5% to 6% constant currency revenue growth on a continued growth in the second half, in particular, in North America similar to what we saw in quarter two. We expect EMEA to recover to the low single-digit growth in the second half. And as I said, we witnessed the beginning of that as we exited Q2, and OEM accelerating growth in the second half and the year. And Larry this is the business that we have good visibility on. Our backlog here is normally a quarter ahead, so we are reasonable confident on the OEM accelerated performance in the later half. In APAC, we expect to see a cardiac and Southeast Asia recovery in the second half and continued growth in China and Japan. If I look at it from a product side, we believe that Vidacare will continue to be a contributor to growth in the second half. Our PICC products with our new preloaded PICC with Chlorag+ard technology will be a contributor. And while not expecting a big contribution from FERC events, we do expect the accelerated growth from the other new products from our surgical suite including MiniLap, EFx, ISI ports. And finally, from a product perspective, we expect laryngoscope blades continue their very strong growth trajectory. I am not forgetting Larry in the final quarter, we have one extra billing day, which will also accelerate that growth for us. And quarter four Larry physician has been our strongest quarter. So, a good place to have an extra billing day.
Larry Keusch:
Okay, that’s extremely helpful. Two other quick questions, so if I just do the math, the second half would have to do 7% to 9% constant-currency growth to hit your 5% to 6% guidance for the year. I'm just trying to see if you can help us calibrate a little bit how you think about the third quarter versus the fourth quarter? I know, again, you mentioned the fourth quarter will be significant in growth, but just help us think about how we jump from the 2Q to the 3Q. And then the other quick question is if you could just quickly discuss the backorder situation in the balloon pumps?
Benson Smith:
So the backorder situation, we had on the contrast deal with that personally, and then I’ll come back Larry to the quarter growth. So the backorder situation on the pumps, we had an issue with production of our balloon catheters. We are able to get all our shipments out to the U.S. Obviously, getting them overseas at the end of the quarter proves a little bit difficult for us. So therefore, we had a backorder situation at the end of the quarter. That was flush through Larry in quarter three. And again just coming back to the other part of your question, within the next two quarters, again we expect to see sequential incremental improvement across all of our businesses in Q3 and Q4. Q3 is reasonably good comparable for us in the prior year so we are pretty confident on accelerating that growth and then continue that into Q4. So that's our expectation is continued acceleration of growth through Q3 and then I know that will step up into Q4 Larry.
Larry Keusch:
Okay. Terrific. Thank you.
Benson Smith:
Larry, this is Benson. Just to elaborate on that a little bit the we are not the only driver improving in EMEA it's certainly one of the biggest levers we have. And it's not unusual to see and pay economic times some of those European countries slow down on their letting loose of purse strings for healthcare. That usually have about a three to six month duration and there is political pressure that they start to spend again. We start to see that spend occur towards the end of second quarter and as we sit here today we are relatively confident that that's going to continue, there is an acceleration in third quarter but than an even bigger acceleration of that in the fourth quarter. So, that coupled with the OEM numbers, we think gives us pretty good visibility and confidence in hitting those numbers.
Larry Keusch:
Okay. Terrific. Thank you for all the color.
Operator:
Thank you. And our next question come from Brooks West of Piper Jaffray. Your line is now open.
Unidentified Analyst:
Hey, good morning, guys. This is [Tom] (Ph) on for Brooks. Thanks for taking my questions and congrats on a great quarter.
Benson Smith:
Thanks, Tom.
Liam Kelly:
Thanks Tom.
Thomas Powell:
Thanks.
Unidentified Analyst:
I appreciate all the commentary in the prepared remarks on Percuvance. I was just hoping you could remind us on that total opportunity for that product? And then maybe just help us frame the launch cadence, in terms of revenue growth contribution and if there is anything you'd call out on mix impact to the margins from Percuvance that would be helpful.
Liam Kelly:
On the margins, first of all, it's accretive to our overall margins Tom, so that's why we are excited about this particular product. From a launch perspective we have now got the generation two, as I said in my prepared remarks launch within EMEA. We are currently showing the first generation in the United States. We expect to have the launch of the second generation in the United States in this quarter, quarter three. We don’t have a significant amount of revenue in 2016 but then we see some acceleration in 2017 and a further acceleration 2017 but we really expect to see the impact of it. Regarding the total market size opportunity for this, we see this as being an opportunity between $300 million and $400 million based on taking a 30% of the laparoscopic procedures in the marketplace today.
Unidentified Analyst:
Okay. Great, thank you. And then I know we talk about this every quarter, but I just want to get your updated thoughts on M&A and more specifically if you could just comment on what the gating factors are to getting deals done? Is it valuation or scarcity of assets? Just any commentary you have would be very helpful. Thank you.
Benson Smith:
So this is Benson. We have a lot of specific requirements in acquiring a company and I would say that it's true that valuations have crept up somewhat. However, the things we have said no to have to more view with issues that came up during due diligence that we felt would affect our ability to get those synergies we would have expected out of the deal. In terms of low rates things to look at we have actually been as busy as we have ever been in terms of investigating investigating potential acquisition charges. I will just review my comments, so we think that patients as a virtue when it comes to acquiring our companies and so far there hasn’t been something that's been sold at least why we have bought that.
Operator:
Thank you, and our next question will come from Kristen Stewart from Deutsche Bank. Your line is now open.
Kristen Stewart:
Hi, thanks for taking the question this morning. Wondering if Tom, you can just kind of walk through the increase in EPS guidance? I know last quarter there was a bigger beat than the raise, and it seems like this quarter it's much of the same. So, I'm just wondering if there is some moving parts there? I know that you talked about expectation for a strong second half and some investment spending. Maybe just walk through the outperformance this quarter relative to the amount that you are expecting to see for the balance of the year?
Thomas Powell:
Okay, this is Tom. I'll fill that. So, a little background and give you an overview of how we are thinking about the higher results, the moving pieces as you mentioned and how that plays into guidance. So for the second quarter the increase in EPS guidance of $0.09 at the midpoint is closely aligned with our second quarter compared versus our internal projections. And our internal projections for the second quarter moved ahead of free consensus. So for the year, we have raised guidance $0.19 as the midpoint which considered the number of factors including favorable FX, strong operating performance and the decision to increase investment behind selective product introductions. We currently expected FX will be approximately neutral to EPS for the year versus our original assumption of the $0.11 headwind, and the upside of the $0.11 reflects full for VOIs year-to-date favorability of currency as well as some improved expectations for the second half of the year. Now at the same time we continue to receive positive feedback regarding both Percuvance and protector in the product introductions and are therefore allocating additional resource in support of those product introductions and then future revenue growth. And finally our year-to-date operating performance has been strong. We have done a good job of leveraging the P&L to drive earnings growth ahead of expectations that has now come we are possible to increase investments and let additional earnings drop through the bottom line. So our current projections include adjusted EPS growth in the range of 15% which is obviously after when we started the year. Our bottom line is ever achieving, what we have said have to achieve and have been able to provide additional investments funding as a result of some of the upsides in both our operating performance and FX.
Benson Smith:
I would add some color to that. Liam and I just recently both attended a cadaver lab for Vidacare. And those about a until we got those about 170 people who signed up there, the interesting thing for us was that most of those people were existing the Vidacare users but they typically have been inserting the Vidacare into the leg versus the shoulder. A shoulder placement has much higher flow rates, it has much better absorption, and really opens up the market for us in a substantial way but what we learnt was people won't automatically shift from the leg insertion to the shoulder insertion and typically actually a candidate attend the cadaver lab and go through that process. So we want to continue to make particularly investments in clinical training for those acute product areas that high margins and what we think our high growth opportunities for us they are going into 2017.
Kristen Stewart:
That makes sense. And then I guess just looking at all the restructurings, you had mentioned that everything remains on-track, so or are we seeing some of the savings potentially coming through perhaps a little early than expected maybe looking out into 2017?
Thomas Powell:
So for the restructuring programs, we are largely on-track with expectations. We had discussed previously little bit of delay in wet kits. We are working to resolve that, but that’s not a significant impact. What we are seeing, this quarter we are starting to see some good benefits coming through as a result of the 2014 footprint realigning program. And those benefits are coming through the balance of some the offsetting costs that frankly that gave it any benefits for last year. What we aren’t yet seeing are the benefits from the second phase of the footprint’s structuring program. We do expect to start seeing those benefits really for next year and primarily the year following. So a number of initiatives on the footprint that are delivering results. In addition, we have a number of cost improvement programs, aside from footprint that are delivering meaningful results quarter-in and quarter-out, so there is really the productivity gains going on in there in our operations group right now. We also had a pretty clean quarter relative to some one-off expenses that impacted this last year.
Kristen Stewart:
Okay, great. Thanks so much guys.
Operator:
Thank you. And our next question comes from Dave Turkaly from JMP Securities. Your line is now open.
Dave Turkaly:
Just looking at the margins again here, obviously it's been a big part of your story historically. And I think you guys have said 2016 to 2018 you could get 300 to 400, or 350 to 400, additional basis points on the gross margin side. But given where we are today and how you have gotten there, I would just like to get some thoughts on the growth side. And then I know you said 1 for 1 to adjusted operating margin throughout that 2016 to 2018 time frame. And clearly this quarter it was much higher on the operating side. I'm curious if you think that should be a trend that may, we may be able to follow and that could continue looking ahead. Thanks.
Thomas Powell:
This is Tom, I’ll see on that. And so it's obviously a distribution to the end, a good chance to have. But just for the background for everyone on the call. So at our Analyst Day event, we outlined a multiyear plan FY2018 we expect increase, both in gross margin and operating margin by 350 to 400 basis points beyond where we ended 2015. And we further indicated that the operating margin increase was a minimum and that we would work to drive additional financial leverage. I wanted to make sure that we had adequate funds available to the launch of new products and other strategic investments. So given all of that, the gross margin target, as we factor in where we ended last year, it's 56.2 to 56.7 operating margin 25 to 25.5, and so recognizing that the midpoint of our 2016 operating margin guidance were already two thirds of the way to that 2018 targets. One might think we have got additional room for upside, and we potentially do. But there are a couple of points that I want to outline. First of all, with the temporary repeal that med device tax, which added about 70 bps to our 2016 operating margin, and this repeal with not contemplated and we provided 2018 guidance and could provide additional upside to that guidance should the repeal be permanently inactive. Second, is that we want to make certain that there are sufficient funds available for support of the launch of new products. So, while we are making great progress now on margin expansion, we also want to put some of that progress into investment to make sure that the future growth with Vidacare, Percuvance and other products is robust as it can be. And thirdly, while we have been successful supplementing our internal R&D efforts with late stage technology acquisitions. Over the next couple of years we want to continue to build out a level internal R&D spending again make certain that we have got a pipeline to deliver revenue growth into the future. So the bottom-line is that if you would exclude the benefit of the medical benefit would feel we expect to accomplish approximately 50% of that operating margin target by the end of this year. And we think that positions us quite well to achieve our 2018 target we feel very good about where we are to accomplish that. You are getting to see some upside from the med device tax, that's currently repealed and as mentioned we gave the guidance. We will continue to drive upsides that one to one relationship of gross to operating margin.
Dave Turkaly:
Thank you for that. That is very detailed, and congrats, it's not often that you see companies that can continually expand their margins as you guys have. So there should be some credibility behind that. Maybe just one on the products side, obviously it seems like your vascular results were strong and they led the way as we were hoping they would. Any color on the PICC market? Competitors seem to be indicating that it is growing healthily, and you mentioned a new product. I guess I would just like to hear your thoughts on your portfolio there and how the overall market is. Thanks.
Liam Kelly:
Okay. So, it's Liam here. So, our big business in North America grew by over 8% in the quarter so that for us was a really nice rebound. Our Chlorag+ard pre-loaded PICC is a new product, it's a two and three lumen product that is accelerating growth. We have the only PICC on the market that is both anti-microbial and anti-thrombogenic and that gives us a strategic competitive advantage against our competitors. And we see this as an opportunity for a sustainable long-term growth in our PICC segment and we continue to take market share. Globally our PICC business is up 6% and again very encouraging and we expect to see that accelerated as we continue to roll out the pre-loaded PICC. We also have some positioning systems that are unique to Teleflex. So when you talk about the PICC market you also need to talk about the positioning systems and an acquisition we did late last year out of positioning technology will come to the market late quarter three early quarter four and that again will give us an opportunity to be more competitive in this space. So we are very enthusiastic about our options in the PICC space.
Dave Turkaly:
Thank you very much.
Operator:
Thank you. And our next question will come from David Lewis from Morgan Stanley. Your line is now open.
Scott Wang:
Hi, guys, good morning. This is actually Scott Wang in for David.
Benson Smith:
Good morning.
Scott Wang:
I guess first a question for Liam. Liam, I think I heard you say that Vidacare growth this quarter was 30%. And I was wondering if you can walk us through what drove that acceleration, because I think in the past, I think Vidacare growth has been trending more along the lines of like 20%?
Liam Kelly:
It has been trending on the 20% range you are correct and we still expect it to be north of 20% for the entire year. Within this quarter we had a really tough comparison and it grew and it grew in total in the mid teens. The EZ-IO product in this quarter performed very, very well and the OnControl products performed even better. So cumulative with 30% growth we see expansion in the hospital segment in particular on the EZ-IO where we see more adoption for the difficult vascular access and we see more hospitals using this product. And as Benson said earlier about our cadaver lab, hospitals will be more inclined doing the deposit and the shoulder. We are a lot of clinical education to encourage people to place that product if you would imagine in a busy emergency room or in an intensive care area. Having access to the shoulder is a much easier sight than getting to the leg and obviously clinicians are now starting to move to the shoulder and get higher flow rate, to get better infusion of the therapy they are applying. And therefore that continues the acceleration of the hospital, and even in the EMS space, back in the day when we bought Vidacare, we thought that was starting to saturated. That is definitely not the case. There is more and more adoption of the products in the emergency space, and we continue to accelerate our growth overseas as well. And then it is really where the future opportunity for Vidacare is in the ongoing growth of Vidacare is to continue to compare it's ambulance services in Europe, hospitals in Europe, ambulances services in Asia and hospital services within Asia.
Scott Wang:
Very helpful. Thanks. And I guess a couple questions for Tom on guidance. Tom, on foreign exchange, given that the new euro rate assumption underlying your guidance is at 1.09, up from 1.06, and FX is now neutral to EPS, which is a little over $0.10 improvement by my math, but you guys didn't reduce the top-line hit from FX to sales. Can you walk us through what were some of the offsets to the improvement in your euro rate assumption on growth?
Thomas Powell:
Are you referencing the 3% to 4% reported?
Scott Wang:
Yes.
Thomas Powell:
It's largely a range that that we are looking at so if we do see some of improvements in the Euro we see some abbreviation in other areas throughout the world so it's just combination of those different currency modes.
Scott Wang:
Fair enough. And can you also help me understand your margin guidance a little bit versus your 2Q results? Obviously operating margins were incredibly strong for the second quarter, and it seems like, for the balance of the year, operating margins are going to be a bit lower. My sense is, from your commentary, that part of that is attributable to increased investment to support probably the launch of Percuvance, as well as some of your newer product lines. I was just hoping you can walk us through some of those offsets?
Thomas Powell:
Okay, sure well. First of all I would look at the longer trends on margins specific quarters can have higher or lower levels of spending that belong on tissues, we had a pretty clean quarter both in the growth and operating margin this year as last year there were some comps un-favorability to comps that came in little bit extra bump. But overall, if we look at where we are on the back half of the year we are expecting overall operating margin to be kind of inline to slightly less than where we are in the second quarter with the fourth quarter being particularly stronger than the third. We are intending to make investments in the third quarter to support these product offerings into and that's going to have a little over margin expectation as result. But overall, our operating margin, as we look to the back after the year, we will be largely in-line with where we are in the second quarter. I think just slightly under second half versus second quarter. On the gross margin-line, we expect again to be largely in-line with where we are in the second quarter and modestly trending up wards depending on how mix plays out.
Scott Wang:
That's great, thanks.
Operator:
Thank you. And our next question comes from Jason Wittes of Brean Capital. Your line is now open. Jason your line is now open.
Jake Elguicze:
Operator, I think you can go to the next question please.
Operator:
Our next question will come from Anthony Petrone from Jefferies. Your line is now open.
Anthony Petrone:
Maybe to go back to the price discussion in terms of the portfolio and the performance in the quarter, I guess, specifically price was called out as a contributor in vascular North America and surgical North America. So, maybe you can provide a little bit of an update on the pricing dynamics in these markets? Which products are driving price, and what is the runway that the Company still has as it relates to price gains specifically? And then I will have another one on the OUS PICC market.
Liam Kelly:
Hi its Liam here. So we have said that you can expect a longer-term fee about 20 basis points of price from Teleflex moving forward, and that’s roughly what we saw within this quarter. The pricing in our vascular segment mostly came from our arterial product lines and that was as a result of some contract renegotiations that we completed earlier on in the year, in our surgical business within our instrument and some in our polymer clips. So our expectation is that we still see opportunities to take price long-term in our more differentiated products where we have market share. We did see slightly price degradation in EMEA which offset the pickup that we made in North America. But on balance it was on 20 basis points. So as I said, we do expect to see that level of pricing be available to as longer-term. And we will continue also to do our dealer to direct, which also does have a longer-term pricing point as we take those business as direct. So expect the same as what you see from us in our current state is I guess would be our guidance.
Anthony Petrone:
That’s helpful and then on the OUS PICC opportunity, one of your competitors is making a push into several emerging markets, in particular, China. And so I'm just wondering your views on the OUS PICC market in emerging markets and whether or not that is in a longer-term growth outlook for the Company?
Liam Kelly:
Okay so if I look at emerging markets in PICC specifically, in China, we have only got our first generate PICC registered in China. Our Chlorag+ard technology PICC, our pre-loaded PICC are not yet registered there. We anticipate having the first of our newer generation PICCs registered in quarter four this year or quarter one of next year and that will give us a springboard to attack that market in China. In Latin America, our PICC business is up 11% and we expect to see continued growth there. We have run a number of training programs in clinical education in Latin America and we believe that is driving the uptick in our PICC market in that area. And we also believe that the acquisition of [NewV] (Ph), which is our lower cost conformation technology that we bought last year that would have accelerated our position in these emerging markets where quite frankly they are just not willing to pay for a higher cost positioning system that we offer in the United States.
Anthony Petrone:
And just again last for me, back to the U.S. would just be any update you can provide on procedure volumes, a number of your competitors noted that we are seeing a tailwind from procedure volumes, so anything you can add there will be helpful. Thanks again.
Liam Kelly:
So on the data we see externally tells us the procedure volumes are up-ticking moderately so we think we are getting about 1.5% to 1.7% in procedure volumes. All the other volume gains which we gained 5.5% in this quarter we believe is coming from taking share from change in the mix of our products within the marketplace and the trading the customer up which also expands our gross margins.
Anthony Petrone:
Thank you.
Operator:
Thank you. And our next question will come from Richard Millar from Leerink Partners. Your line is now open.
Ravi Misra:
Hi, good morning, it's Ravi in for Rich. Can you hear me all right?
Benson Smith:
Yeah, Ravi good morning.
Liam Kelly:
Good morning.
Ravi Misra:
Good morning, thanks. Just wanted to follow up a little bit on the FX commentary that was asked earlier. Trying to understand the cadence, the top-line still has the impact, but you are sort of absorbing it on the bottom line. Is that that you are reinvesting in those areas that would be effective on the top-line that's kind of acting as a natural hedge? And if so, going back to the reinvestments, where are those going? Can you give a little bit more detail on how you are reinvesting some of this upside that you have done in the first half? Thanks.
Benson Smith:
As we look at the guidance that we have outlined I'd say that there is a couple of things going on. First of all, strong operational performance as mentioned, we also have some FX benefit and we are doing two things with that, one is following some of that through the bottom line to increase guidance and the other is finding investments behind some of the new product introductions. As we have talked throughout the call you have heard a number of investment, one was behind Vidacare and additional cadaver labs we are seeing great returns on those investments. In addition, we have received very, very favorable feedback from the doctors who have been trialing the Percuvance product. And we want to make sure we are out there providing the support to help that product get up and to the hospitals value analysis committees. And so there are a number of new products that are in the pipeline that we want to make sure there is adequate funding behind. So that's helpful, Liam do you have any other.
Liam Kelly:
The reason we are putting these additional investments behind Percuvance is because of the very positive feedback. The fact that we are ready with this generation of products, what we have seen is that the more institutions we can get into the funnel, our hit rates getting through the value analysis committees is very high. So, we want to make sure that we are getting more and more doctors introduced to the product, more and more surgeons using the product and more and more surgeons willing to go to value analysis committees and take their case to use these products.
Jake Elguicze:
And Ravi this is Jake to address may be your first question on FX. I mean there is really a lot of puts and takes in terms of the different currencies that's long during the course of the year versus our original expectations, many of which from a profitability standpoint, I don't have still that same impact. So, while the Euro was a little bit favorable compared to probably our initial thoughts, there are other currencies the Pound, the Canadian Dollar and a variety of others that we operate in that kind of went in an opposite direction still keeping that full-year on FX rate headwind assumptions revenue at about approximately 2% type level.
Ravi Misra:
Great, thank you.
Operator:
Thank you. And our next question comes from Matt Mishan from KeyBanc. Your line is now open.
Matt Mishan:
Hi, thank you. Good morning, and thank you for taking my questions. I think when you originally gave guidance, you teased out some of the various moving pieces like volume, new product growth, pricing and so forth. And in your original assumptions, you had I think new product growth growing 200 basis points to 250 basis points for the full-year. And you have been coming in that 100 basis points to 150 basis points for the first half, and I'm just curious, what drives that back-half acceleration in new products growth really into that 3% range to kind of hit your guidance? Especially given, I don't think a big piece of that would be Percuvance or LMA.
Liam Kelly:
Hey, Matt. How you are doing? It's Liam here. You are correct not a big piece but it's event LMA trajectories it's somewhat of a contributor in the second half. The main contributors are the ones that I have launched line but our growth for the quarter. Our Chlorag+ard pre-loaded PICC is a big driver in the second half. Within our surgical group, we have the MiniLap, EFx and ISI ports and our laryngoscope blades in our surgical business units. So again, what we expect to see in Q3 and Q4 is an incremental improvement and a sequential improvements in our new products. And also Matt what you want to bear in mind is some instances let me take the Chlorag+ard PICC for example. There is some cannibalization within that number so the what we see in the first half of the year as we get it's even if the products is not in the marketplace we are still selling the core PICC and pre-loaded of that customer, so you will see represented in volume rather than in new products.
Matt Mishan:
Okay, got it. That's helpful. And then with Percuvance, I think in your original conversation around what the long-term opportunity was, you had included about 3 to 4 million of applicable procedures, but that was all U.S. based. And now that you have had the products out in Europe for a little over a quarter now with the full commercial launch, what do you think the opportunity is in Europe in particular? Are there any limiting factors that would be different, where your expectation would be much lower in Europe than it would be in the U.S.?
Liam Kelly:
So, normally you would expect to get a - first of all we are not going to change our expectations for Percuvance Matt, we are going to maintain the 300 to 400 million as the market opportunity until we get farther down the road here and get some traction on it. So we will maintain that and it was based in the U.S. number, you are correct, but down the less I think to be conservative, we should maintain that number. What we are seeing with Europe is similar to what we are seeing in the U.S. and it is very, very strong acceptance for the product. The one thing you want to get from our product math is it needs to be intuitive. So when you put it in the hands of a surgeon they should get it immediately and with this product they do, they get it immediately. But similar to the U.S. they are not called value analysis committee to oversee, but there is a pricing board similar methodology that you go through to get the products approved and that’s what we are working through at the moment. In Europe alone we have over 70 surgeon trials that we have completed with this product.
same-store:
Matt Mishan:
Great, and just one quick clarification. I didn't catch what - did you change the operating margin guidance for the full-year? I didn't hear.
Benson Smith:
We did. So we have increased by 50 basis points on the lower and upper end to 24% to 24.5%.
Matt Mishan:
Okay. Thank you very much, guys.
Thomas Powell:
Thanks.
Operator:
Thank you [Operator Instructions] At this time, I’m showing no further questions. I would like to turn the call back over to Jake Elguicze, Treasurer and Vice President of Investor Relations for any closing remarks.
Jake Elguicze:
Thanks, operator and thanks to everyone for joining us on the call today. This concludes our second quarter 2016 earnings conference call. Have a good day.
Operator:
Ladies and gentlemen, thank you for participating in today’s conference. This does conclude the program and you may now disconnect. Everyone have a great day.
Executives:
Jake Elguicze - Treasurer and VP, IR Benson Smith - Chairman and CEO Liam Kelly - President and COO Thomas Powell - EVP and CFO
Analysts:
Larry Keusch - Raymond James Dave Turkaly - JMP Securities Matt Mishan - KeyBanc Jason Wittes - Brean Capital Brian Weinstein - William Blair Anthony Petrone - Jefferies
Operator:
Good day, ladies and gentlemen, and welcome to the Teleflex Incorporated Q1 2016 earnings conference call. [Operator Instructions]. As a reminder, this call is being recorded. I would now like to introduce your host for today’s conference, Mr. Jake Elguicze, Treasurer and Vice President of Investor Relations. Sir, you may begin.
Jake Elguicze:
Thank you, and good morning, everyone, and welcome to the Teleflex Incorporated first quarter 2016 earnings call. The press release and slides to accompany this call are available on our website, at www.teleflex.com. As a reminder, this call will be available on our website, and a replay will be available by dialing 855-859-2056, or for international calls, 404-537-3406, pass code 90662973. Participating on today’s call are Benson Smith, Chairman and Chief Executive Officer; Liam Kelly, President and Chief Operating Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Benson, Liam, and Tom will make some brief prepared remarks, and then we’ll open up the call to Q&A. Before we begin, I’d like to remind you that some of the matters discuss in the conference call will contain forward-looking statements regarding future events as outlined in the slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that cause actual results or events to differ materially include, but are not limited to, factors made in our press release today, as well as our filing with the SEC, including our Form 10-K, which can be accessed on our website. With that, I would like to now turn the call over to Benson.
Benson Smith:
Thanks, Jake. Good morning, everyone. I’m pleased to report a very solid first quarter that exceeded our internal expectations in nearly area, which allows us to raise our full year 2016 adjusted earnings per share guidance even at this early point in the year. While Liam and Tom will go through the numbers in more detail, I would like to highlight some of our key performance metrics. Overall, I’m delighted with the company’s Q1 results, but I am glad to have the first quarter of the year behind us. As I am sure you’ll remember from our last earnings call, for a variety of reasons, we believed that first quarter of 2016 was going to be our most challenging quarter of the year. This principally had to do with a difficult comparison as a result of a very strong quarter in 2015, two less shipping days in Q1 of this year, a significant foreign currency headwind, and some other one-off events we expected in Q1. Beginning with revenue, on an as-reported basis, revenue slightly exceeded our initial estimates and was helped by a modestly more favorable foreign currency environment versus our guidance assumption. From a constant currency perspective, our growth rate of 1.1% was slightly under our expectations, but just under it. That being the case we saw nothing in the quarter that leads us to change our expectations for the year, as we are reaffirming our full year constant currency revenue growth range of between 5% and 6%. A few more details on Q1 revenue; it’s always difficult for us to predict with pinpoint accuracy how the loss of two shipping days will precisely affect revenue for a given quarter, and now retrospectively I believe we had modestly underestimated the two day impact when the quarter ended on a holiday weekend. In addition, we had a few unexpected events; for example, we had an OEM customer push out a fairly large order from the end of Q1 to the beginning of Q2. As a result, we do not expect any of these events will have any impact on our ability to achieve our full year constant currency revenue growth numbers, and we continue to foresee a considerable uptick in growth rates beginning in the second quarter and continuing for the remainder of the year. Moving to adjusted gross margin, our results were slightly better than our initial expectations and the over-performance in this area came primarily from improved mix. Turning to adjusted operating margin, progress here during the quarter was excellent and exceeded our internal expectations to an even greater extent than adjusted gross margin. While our adjusted EPS for the quarter was aided by favorability in FX as compared to our original guidance assumptions, the overwhelming majority of our earnings upside were the results of very good operational performance and continued P&L leverage. Turning to our overall view of the macroeconomic conditions, they remain largely unchanged from our last earnings conference call. We continue to expect good growth out of North America and Asia, moderate growth out of Europe, and some challenges with respect to oil producing countries as well as with Latin America. All of this is built into our guidance. Finally, we continue to make good progress on key initiatives, including our footprint consolidation efforts, material substitution programs, and higher margin new product launches. All of these items remain on track and should allow us to deliver both short and longer term margin targets that we’ve laid out previously. Now before turning the program over to Liam, I want to congratulate him on his promotion to President and Chief Operating Officer. In this new capacity, Liam’s role will be expanded to include oversight of our global manufacturing operations, while he continues to have responsibility for our global commercial functions. Liam has been a reliable performer even before my arrival at Teleflex in 2011, and he continues to be deserving of new and increased responsibilities. He is an example of our increased management bench strength and our commitment to develop future Teleflex leaders from within. Liam, congratulations.
Liam Kelly:
Thank you, Benson and good morning everyone. For the consolidated company, first quarter 2016 constant currency revenue grew 1.1%. If you were to normalize our first quarter results for the two fewer shipping days, our constant currency revenue growth would have been approximately 3.3%. As mentioned earlier, we faced a tough comparable in Q1 2015 where if you recall, we grew by 5.2% with one less shipping day. This comparable eases in quarter two and three, in addition we will have one additional shipping day in quarter two and another in quarter four. As such, we expect to see a strengthening in sales growth beginning in quarter two, and although this phasing may be lumpy, this is consistent with our internal expectations on revenue for the quarter and year. Sales of new products introduced to the market contributed 1.1% and were the main driver of revenue growth in the quarter. New product sales were particularly strong within our Surgical and OEM businesses, as well as within our EMEA segment. And while not yet a key contributor in terms of revenue dollars, we continue to make progress in two key strategic initiatives, the launch of Percuvance within our Surgical business, and the LMA Protector within our Anesthesia business. First to Percuvance; the recent stage of meeting in Boston was an important event signaling our upcoming full market release. Clinician feedback continues to reinforce what we learned in our limited market release, which that Percuvance is equal to standard 5 millimeter laparoscopic instruments in terms of rigidity, so causing less trauma to the patient with virtually scarless incisions. The strength and functionality of the 5 millimeter end effector is a exceeding our initial expectations, even during complex cases with challenging patient anatomy. We recently completed the first cases with our second generation Percuvance device in Europe, where we are currently in full market release, having received a CE mark in quarter one, while within the US, we are currently selling our first generation Percuvance device and are working with the FDA to get our second generation device 510(k) approved. The FDA recently informed us that we will need to do a sterilization study and update the instructions for use, prior to commercialization of the second generation product within the US. And as such, it is our belief that we will be in a position to do a full market release of our second generation Percuvance products offering in early Q3. We do not expect this to have a negative impact on 2016 revenues, as we will continue to demonstrate and sell the first generation product. Next to the LMA Protector; we have registrations in places from most major markets, and continue with our controlled market rollout with an anticipated full market release in 2017. The Protector is currently being evaluated in 40 hospitals around the world, as part of this rollout. This compares to only 11 hospitals, when I last spoke to you on our February conference call. Clinical feedback has been very positive as the design is getting high marks for its seal pressure, which is a critical component to protecting the airway and facilitating ventilation. I am pleased with the status of both of these product launches and I continue to believe that both are large, multi-year opportunities for Teleflex. Turning to other components of revenue growth; previously completed acquisitions and distributor conversions continue to pay a benefit, and during the quarter added approximately 70 basis points of growth, which was primarily due to the acquisitions of Stenning, Human Medics, and Trintris. Moving to core product pricing; during quarter one, we saw the average selling price of our products expand approximately 20 basis points. This was primarily due to increases in surgical and vascular access, somewhat offset by a decline in European product pricing. Finally, during the quarter, sales volume of existing products declined by approximately 90 basis points. This was primarily the result of two fewer shipping days in the quarter, as well as the impact of destocking by our large US distributors. The sales [tracking] from these distributors show positive sales volume at a hospital level. In addition as Benson said a few moments ago, we also had some of the OEM customers push out orders to the second quarter, and in North America we saw an anemic flu season, which principally affected some of our respiratory therapy and CVC products. Next, I would like to provide some additional color surrounding our segment and product related constant currency revenue growth drivers. Vascular North America first quarter revenue increased 1.5% to $81.5 million. The increase in vascular revenue was largely due to the sales of Vidacare, EZ-IO and OnControl devices. Now to Anesthesia North America; first quarter revenue was $46 million, up 1.6% versus the prior year period. Growth in this segment was driven by increased sales of Vidacare, EZ-IO and airway management devices, somewhat offset by lower sales of regional anesthesia product offerings. Turning to our Surgical North America business, its revenue increased 3.1% to $38.9 million. The increase within surgical is attributable to higher sales of chest drainage and Mini-Lap products. Shifting to our overseas businesses, EMEA revenues declined on a constant currency revenue basis by 1.9% and totaled $122.1 million. The decline in European revenue was the result of the shipping day impact and a reduction in some products’ pricing. Moving to Asia, our first quarter revenue increased 6.4% to $49.2 million. The quarterly increase in Asia revenue was primarily due to higher surgical ligation and central venous catheter sales, and the positive impact from the acquisitions of Stenning and Human Medics. Now to OEM; revenue in the first quarter decreased 1.6% to $34 million, almost primarily due to lower sales of catheter and extrusion products, as well as the previously mentioned order movement from quarter one to quarter two. This was somewhat offset by an increase in performance fiber sales. Given the underlying business trend, it is our firm expectation that OEM sales will rebound nicely during quarter two. Lastly, first quarter revenues for the businesses within our all other category was up 2.6%, totaling $53.2 million. Growth here is primarily attributable to sales of the additional cardiac intra-aortic balloon products. This was somewhat offset by lower sales within Latin American markets, due to the macroeconomic issues facing those countries. Finally before I turn the call over to Tom, I would like to update you on additional group purchasing organization and IDN agreements that we received during the quarter. Building on our success in 2015, during the first quarter we won 12 new agreements and extended another 20. This quarterly total surpasses what we achieved in the fourth quarter of 2015 and now represents the largest number of agreements awarded in any single quarter since we became a pure play medical device company. As you will continue to hear me say, these relationships are extremely important to us, as they bolster our ability to continue to drive volume growth across our product portfolio. Of the agreements won in quarter one several were Sole Source Award. That takes me to the end of my prepared remarks. At this time, I would like to turn the call over to Tom for him to review our financial results for the first quarter and our 2016 guidance. Tom?
Thomas Powell:
Thanks Liam and good morning everyone. Given the previous discussion of the company’s revenue growth drivers, I’ll begin my prepared remarks at the gross profit line. But before I do, I’d like to reinforce that the company is off to a solid start in the first quarter of 2016. During the quarter, we realized expansion of both the gross and operating margins versus prior year levels. Financial leverage was good, with 19.6% adjusted net income growth being generated from flattish revenue gains. Cash flow generation was also strong. Additionally currency headwinds moderated during the quarter versus what we’d experienced throughout 2015. Given the strength of the first quarter results and our outlook for the remainder of the year, we are raising adjusted earnings per share guidance by $0.10 on both the top and bottom end of our adjusted EPS range. Turning now to first quarter results; for the quarter adjusted gross profit was 227.8 million, versus 224.8 million in the prior year quarter. Adjusted gross margin was 53.6%, representing a 130 basis point increase when compared to the prior year period and positioning us well for the achievement of our full year gross margin targets. During the first quarter, adjusted gross margin benefited from increased sales of higher margin products primarily in the Asia, Anesthesia, and the All Other segments, the impact of 2015 acquisitions, distributer conversions, and net favorable pricing. Also in the first quarter, adjusted operating margin improved by 190 basis points. The increase was largely the outcome of the gross margin gain, control over discretionary overhead spending, and the impact of the suspension of the medical device excise tax. For the quarter, adjusted operating profit and margin were $95.1 million and 22.4% respectively, versus $87.8 million and 20.5% respectively, in the prior year quarter. Continuing down the income statement; for the quarter, adjusted net interest expense decreased to approximately 10.2 million versus approximately 13.8 million in the prior year first quarter. The decrease in interest expense reflects the refinancing of the 6 and 7/8 senior subordinated notes in the second quarter of 2015 and the repayment of approximately 50 million of revolver borrowings in the third quarter of 2015. In the first quarter, the GAAP tax rate came in at 4.9% due to a tax benefit arising from the settlement of an international tax audit. That benefit was added back for purposes of calculating the adjusted tax rate. Our adjusted tax rate was 19%, which is at the mid-point of our 2016 tax rate guidance range of 18.5% to 19.5%. On the bottom line, first quarter adjusted earnings per share was $1.52 or an increase of approximately 17%. Turning now to select balance sheet and cash flow highlights; for the quarter, cash flow from operations was approximately $67 million or an increase of approximately 58% over the prior year. The increase was primarily the outcome of improved operating results and the favorable impact from changes in working capital items, partially offset by an increase in tax payments. From a balance sheet standpoint, at the end of Q1, cash on hand totaled approximately $393 million of which approximately $26 million was located in the United States. Leverage as per our credit facility definition stood at approximately 2.36 times. That completes my comments on Q1 results. Next, I would like to update you on a change made to our capital structure subsequent to quarter end. On April 4, pursuant to separate privately negotiated agreements between the company and certain holders of the convertible notes, the company paid cash and issued common stock to note holders in exchange for $219.2 million of aggregate principal amount of convertible notes. We funded the cash portion of the consideration through borrowings under our revolving credit facility. In addition, we have also received, but not yet settled conversion notices totaling 44.3 million in aggregate principal amount of the convertible notes. The 44 million of unsettled conversion obligations will be settled in June and we expect to fund the cash portion, available cash or borrowings under the revolving credit facility. Following the exchange transaction and after giving effect to the conversion notices the company has received but not yet settled, 136.2 million of aggregate principal amount of convertible notes will remain outstanding. Finally, I will provide you with an update on our full year 2016 financial guidance. Beginning with revenue; for 2016 we are reaffirming our full year constant currency revenue growth guidance range of between 5% and 6%, and we continue to expect as reported revenue to increase by 3% to 4%. Inherent in the as reported growth is the assumption that the euro-to-dollar exchange rate averages approximately $1.06 for the balance of the year. Based on the current rates, this may prove to be a conservative assumption. We are also reaffirming both our previously provided adjusted gross margin guidance range of 54% to 55%, and adjusted operating margin range between 23.5% and 24%. Based on current projections, we expect that the operating margins will come in toward the upper end of that range. On the interest line, we have financed the redemption of a portion of the convertible notes to withdraw on the revolver; however, we are evaluating more permanent financing alternatives and you should not assume that interest expense will provide a source of additional earnings leverage for 2016. Our full year 2016 adjusted tax rate guidance remains 18.5% to 19.5%. Given the continued appreciation in our stock price, we now project a slight increase in our adjusted weighted average share count to 45.6 million shares for full year 2016. Note that the redemption of the convertible notes itself did not have a material impact to the adjusted share count, as a dilution from a potential conversion had already been included in the calculation. On the bottom line, we are increasing our full year adjusted earnings per share guidance range from the previous range of $7 to $7.15 to a revised range of $7.10 to $7.25, which represents growth of 12.2% to 14.5%. The increase reflects both a strong Q1 result and confidence in our outlook for the balance of the year. That concludes my prepared remarks. At this time, I would like to turn the call back over to the operator for questions. Operator?
Operator:
[Operator Instructions] And our first question comes from Larry Keusch from Raymond James. Your line is now open.
Larry Keusch:
Two questions, first Liam, congratulations on the promotion, and Benson just wanted to pick your brain and see if had any thoughts on how we should be thinking about succession planning and timing.
Benson Smith:
So I will repeat my previous comments that I think that our expectation is that we’ll have an internal candidate to be able to replace me. I think we’ll be in a position to talk about more on timing later in the year. But I am personally very comfortable that and as is our Board that we’ve got a good succession spot and intend to share that more publicly as we get closer to the time.
Larry Keusch:
And then perhaps for Benson or Tom or Liam, just remind us again how you take the constant currency growth from the 1% range in the first quarter to 5% to 6% for the year, obviously, implies a significant acceleration. I recognize there’s some extra days in the 2Q and 4Q, but again, just walk us through how that math works.
Liam Kelly:
Larry, I’ll take that, and thank you for your congrats. So if you take it and you take the constant currency growth of 1.1%, then you’re layering the billing days, then you’re at 3.3%, as we outlined on our Q4 results. So if we take that as our jump-off point, and you look at what happened with the OEM business moving out and some of the destocking that we felt within our distributors, that’s about another 1.1%. And then you look at the tough comparables last year, 5.2% with one less billing day, which would be 6.3. That should get you about another percent. So that’s how we bridge it to a 5% to 6% growth rate, and we’re pretty confident, Larry, that we’ll see a nice rebound in quarter two and continue on from there. It’s not a question of waiting for a Q4 to get there this year, so we are pretty confident we will see a nice rebound in Q2.
Operator:
And our next question comes from Dave Turkaly from JMP Securities. Your line is now open.
Dave Turkaly:
I know we had spoken earlier, sort of looking at your segments about Vascular potentially leading the way this year. I know Vidacare did like 20% last year, so I’m curious if you still feel like that could be the strongest segment. And I was wondering if you could maybe help us with what we should expect from Vidacare this year.
Liam Kelly:
Liam here, Dave. Thanks for that. I will deal with Vidacare first. The Vidacare we do anticipate a very solid performance again this year from Vidacare. We expect to see Vidacare growing at the 20% range on a full year basis, and we see it being a contributor to our growth overall. Vascular continues to perform very strongly, as it did last year. And you are correct we continue to see Vascular as a segment that will lead the way in our growth in the Americas and globally.
Dave Turkaly:
And then just one quick follow-up, maybe for Benson because he historically has had good thoughts on sort of what’s happening in the broader macro market. I heard the prepared remarks, but given what we’ve seen from you guys and peers, the year is off to a good start, a lot of beat raises even though it is early, is there anything that you are seeing and I know in the past you’ve experienced, you’ve been able to grow even when the market wasn’t. But on a utilization point or a procedure volume, anything you’d point to, because it seems like just across the sector, there’s been a lot of strength so far this year.
Benson Smith:
Yes, so I would concur that that’s our perspective as well. Liam mentioned the fact that sales out from distributors to hospitals was actually stronger than our sales into distributors, so we are quite comfortable that we are seeing continued robustness in the US market. The one footnote I would say is, there was a relatively strong flu season last year, which didn’t replicate itself this season, but in spite of that, I think we’re going to see quite good growth out of North America. The other growth area for us, and I think for other manufacturers as well, is going to be in China. Europe will be positive, but to a lesser extent and the situation with the oil producing countries has essentially remained unchanged, which is not in good shape, as I said earlier. All of that is built into our guidance and this is consistent from what we’re seeing from other manufacturers as well.
Operator:
Our next question comes from Matt Mishan from KeyBanc. Your line is now open.
Matt Mishan:
Just a couple of clarifying ones for me, did you quantify the impact of the selling days in the quarter on sales?
Liam Kelly:
Yes we did. We qualified it as 2.2% with the two less billing days.
Matt Mishan:
And then what was your new euro assumption?
Liam Kelly:
Our euro assumption remains for the balance of the year at $1.06, and I think that’s one of the areas for upside during the course of the year. What we saw last year though was quite a bit of volatility, and I think in the spirit of some conservatism want to make sure we don’t underestimate what could happen in the third and fourth quarters.
Matt Mishan:
I think that’s fair. And then just in terms of potentially terming out the savings (inaudible) the converts on the debt side. How are you modeling your free cash flow coming in for the year? I feels like $300 million of free cash flow expect is coming that should be able to cover that pretty easily.
Thomas Powell:
Yeah, so that’s in line with our internal expectations, is about the 300 of free cash.
Matt Mishan:
So how are you modeling the impact of that free cash? Are you modeling it going straight to cash and equivalents or are you modeling it to taking it down debt or are you modeling it towards instead of terming out of the convert to actually taking that down?
Thomas Powell:
So in terms of modeling we have not assumed a reduction of debt to our capital structure for the balance of the year. Right now, as we took down or redeemed a portion of convertible notes, we put those redemptions that we paid in cash on the revolver, and so I think the way to think about it is that what we did in the first and early part of the second quarter is not what you should assume instead of the full-year impact of what happens with the converts and/or what’s on the revolver. But I wouldn’t assume that interest expense is a source of additional earnings or leverage for 2016. So if that helps you to better understand it, but we are not assuming that that free cash flow is going to reduce our --.
Benson Smith:
And I think coming at this another way, we continue to want to preserve position liquidity as we see ourselves as a serial acquirer, and we’ll continue down the path of making appropriate acquisitions for the targets that we are keenly interested in.
Operator:
[Operator Instructions] our next question comes from Jason Wittes from Brean Capital. Your line is now open.
Jason Wittes:
I wanted to ask about second-generation Percuvance, can you give us a quick sketch of how it’s improved, and also wanted to know if any docs in the US have gotten their hands on it yet.
Liam Kelly:
Okay, so how it has improved, when we did our limited amount of release, if you’ve seen the Percuvance, you change the heads in order to [extrapacorally], which means outside the body, to actually continue the procedure. The advantage is we don’t make any change to how the surgeon does the procedure. One improvement that we made was the exchange was a screw-on head in the first round, and in the second iteration of the product, it’s actually clip-on. We just did that to speed up the exchange time and it makes the procedure time shorter for the doctor. Yes, it is in the hands, the generation one is in the hands of doctors in the US, and actually we have completed 250 procedures globally with the majority of them being the US. There was 10 sites of the initial launch. 9 out of the 10 sites have committed to using the product moving forward, and four of them have already gone through their back committee and added it to their formulary, and they are actually waiting for the second-gen products to be launched. Now overseas in Europe, we received a CE mark in quarter one, so doctors in Europe we now have sites in Italy, Germany, UK, France, Belgium, the Netherlands, Greece, actually trialing the product as we speak today and we are in active full launch in Europe.
Jason Wittes:
What has been the feedback, I mean on your description, this doesn’t sound like a major overhaul. It just seems like some tweaks. But I’m curious to know if you’ve got initial feedback?
Liam Kelly:
The initial feedback is incredibly positive. The incision is almost scarless, the feedback from the patient, one patient actually said to a doctor - accused a doctor of not doing the procedure because the scar was that invisible at which he was quite amused by --. And the feedback from the doctor is, there’s no change, the surgeons see no change in their procedure. The exchange goes well. They are able to use it for more complex cases than we initially thought, so all-in-all, the feedback from the limited market release and now the full market release in Europe is resoundingly positive.
Jason Wittes:
(Inaudible) from first generation versus second generation is actually what I was asking.
Benson Smith:
So that’s really just the change in the way the end effector is attached. The original generation as Liam said, has to be screwed on. It’s a relatively fine thread, particularly in terms of training the technician on how to make those changes. One of the things that came up during our release was that they wish they had a slightly easier way to do this. This, in fact, is a lot easier way to do it, and there’s not a danger that they’ve only partially screwed the head on and allowing it to come loose. Although, that’s just a theoretical observation since it’s never happened, but there seems to be a greater comfort level with this attachment method.
Liam Kelly:
And we’re very encouraged that we only had to make that one small change from limited market release to full market release, gen one to gen two.
Jason Wittes:
Should we assume a more significant impact in ‘17? Let me rephrase that, can you give us a sense of what we should expect from this in 2016 and sort of then versus that versus 2017?
Liam Kelly:
So the impact in ‘16 is minimal. We are just beginning to build up our base of customers and you should begin to see the impact ramp up as we go into 2017 for the Percuvance and Protector.
Jason Wittes:
Okay, but we should assume that ‘17 will be a more significant year?
Liam Kelly:
That is correct.
Jason Wittes:
One last question for Vascular, you mentioned Vidacare, which continues to do very well. Curious about the other business lines, CVCs and PICC, how they’re doing and what the outlook is for the year?
Liam Kelly:
The outlook for the year on both CVCs and PICCs is resoundingly positive. Within the quarter, because of the poor flu season, both CVCs and PICCs were impacted by that. But we don’t have any concerns for the full year on our vascular business, and we are continuing to be very bullish about our ability to continue to support the CVC franchise and take share with our PICC franchise.
Jason Wittes:
Do you have growth rates for the quarter for those two business lines?
Liam Kelly:
Yes, I do. So our CVC showed a modest decline of about 2%, and our PICC business, again, a modest decline of about $1 million, mostly driven by the flu season.
Benson Smith:
(Inaudible) sales to distributors, not necessarily sales to hospitals.
Operator:
Our next question comes from Brian Weinstein from William Blair.
Brian Weinstein:
You mentioned a couple times US distributor destocking. I’m hoping that you can educate us a little bit as to what’s going on there, what’s driving this, and when do you think that that bottoms out?
Liam Kelly:
Brian, this happens occasionally. About 50% of our business goes through these large distributors, the (inaudible), [dealers and miners], so those people that you’d be familiar with. And occasionally we see that we get tracing some of the shows, the end hospital sales, and occasionally, we will see a trend where they destock their own inventory levels. It normally normalizes within a quarter, and if it just normalizes in a quarter, then it comes back during the year. It’s not going to have any impact in the year. We just happened to see it in this current quarter that we’re in.
Brian Weinstein:
On the restructuring and the facility footprint consolidation, any update there as to how that’s progressing and the impact that that could have in terms of margin contribution this year? Any potential upside that you guys are willing to talk about at this point?
Benson Smith:
I think it’s too early in the year for us to talk about an upside at this point in time, I would say everything is on track as we initially planned for 2016. We expect to see some benefit from this towards the end of the year and more benefit as we move into 2017, but both the phase 1 and phase 2 essentially are tracking to plan.
Brian Weinstein:
And last question for me is on gross margin, last quarter you talked about operational efficiency driving about 60% of the gain and volume and mix driving about 40% of the anticipated gain in 2016. Is that still the way that we should be thinking about it, or are they tracking somewhat differently?
Benson Smith:
No, that’s still a consistent thought in terms of how we are going to get there in the full year. I’d say that in the first quarter, we had a little stronger benefit coming out of mix, but we continue to expect the operational efficiency gains to build as the year progresses, so still thinking along those same lines for the full year.
Operator:
[Operator Instructions] We have a follow-up question from Larry Keusch from Raymond James. Your line is now open.
Larry Keusch:
Benson since we haven’t really touched on it, wanted to circle back and M&A. Well, you guys continue to be extremely disciplined, and just wanted to get some thoughts on how you’re thinking about valuations, and it doesn’t feel like there’s a major sense of urgency given the way the business is performing, and again, just wanted to see how you’re thinking about M&A broadly.
Benson Smith:
Larry, I think our long term view remains similar that the general marketplace is less favorable to smaller companies than it is to the larger companies through a certain scale extent. Those companies that are $50 million to $100 million in revenue have a tough time with IDNs and GPOs. They have a tough time globalizing, that’s becoming a much more important part of a growth strategy. So we think there’s reasonable availability of product lines that we are interested in. We have said no to a couple of things that we liked over the past several months, because we thought the valuations were out of line. So I would echo the point that we continue to be quite disciplined. But also as last year, we continue to be very; very active in many, many smaller acquisitions that I think are more than gap fillers, but good strategic additions for the product line. I think you can expect that to continue with or without a larger acquisition.
Operator:
And our next question comes from Anthony Petrone from Jefferies. Your line is now open.
Anthony Petrone:
Maybe just going back a little bit to Percuvance and just get a little bit of an update there on when do you think you’ll move beyond the initial procedures that you were targeting with that device? I know it’s still early. I think the initial target market in some of the general surgery applications that you called out is around $300 million to $400 million, but there’s clearly a broader market opportunity our there for Percuvance potentially multiples of that. So I’m just wondering, you’ve made some tweaks to the device, is that now set for a broader surgical application or is it still - you’re going after this smaller market within general surgery first, and then that product will expand perhaps in the next 2 or 3 years.
Liam Kelly:
Well, I think the $300 million; $400 million was a sub-segment of the overall laparoscopic market. It wasn’t defined on a procedural basis. When we launched the product first, we thought we would be doing a considerable number of lap callings. We are doing some of those, but we’ve found a broader application for the product in more complex procedures, complex, tiny procedures. But the position of the patient limits the ability of the surgeon to place trocars where they would once placing trocars, and obviously, with our device they don’t need to place trocars. Some bariatric procedures that the surgeons are doing and have used the product for in the limited market release. So the market size is not limited by the procedures per se, but it’s the step taking a proportion of the laparoscopic overall market.
Anthony Petrone:
And then maybe a follow-up also on M&A, I mean clearly a big transaction announced this morning. And if you listen to that call, there’s this bigger-is-better mantra is resonated out of that call as well. Medtronic has commented on that as much, certainly with Covidien. So maybe an update Benson, on your view and Liam on your view on how the hospital market is evolving. Is a bigger bag necessarily better or do you think being more dominant in a smaller product set is still the way to go? So any thoughts there would be helpful.
Benson Smith:
Well, for us it has to be the way to go for the most part since our size is what it is. But I would point to the continued success we have with both IDNs and GPOs in this country, in terms of winning awards and for new products as well. So that notion that GPOs or hospitals want to deal with a limited number of suppliers has some partial truth to it, but there’s still a robust place for product differentiation and for better clinical outcomes. I do think and I’ve said this many times, I think we are big enough to get in front of GPOs and in front of IDNs. We’re big enough to be able to sell our products globally. So I don’t see a disadvantage in our size, I see more of an advantage in our nimbleness.
Anthony Petrone:
That’s helpful, and then one last quick for me is just on the cap structure and the converts, so clearly a portion that was retired. I don’t know if there’s an update on the remaining converts in the cap structure, if there’s any plans for that? Thanks again.
Thomas Powell:
Sure, well, just a little bit of background on the transaction would perhaps give you some insight. As a reminder, the notes come due on August, 2017 we wanted to take steps to redeem some of those notes in advance maturity. Given where the notes were currently trading in the marketplace, we saw an opportunity now to take those notes out at a pretty attractive price for us. And we determined that the best approach was a privately negotiated transaction versus going out with a full tender offer, just given the difference in the premium that would be required between the two. And because we approached this in that manner, there’s a limitation of the amount of notes that could be redeemed at this time. Now, we’re always evaluating the highest and best use of the capital, and so we’ll continue to monitor the terms, the maturities, and the rates, and as I mentioned earlier, you shouldn’t assume that we are finished with what’s been done in the first and early part of the second quarter. So we are continuing to look to see if it makes sense when we can go back in the marketplace to look at the remaining notes.
Operator:
I am showing no further questions. I would now like to turn the call back over to Jake Elguicze for any further remarks.
Jake Elguicze:
Thanks, operator, and thanks to everyone that joined us on the call today. This concludes the Teleflex Incorporated first quarter 2016 earnings conference call.
Operator:
Ladies and gentlemen, thank you for participating in today’s conference. You may all disconnect. Everyone have a great day.
Executives:
Jake Elguicze - Treasurer & Vice President-Investor Relations Benson F. Smith - Chairman, President & Chief Executive Officer Liam Kelly - Chief Operating Officer & Executive Vice President Thomas E. Powell - Chief Financial Officer & Executive Vice President
Analysts:
Lawrence Keusch - Raymond James & Associates, Inc. Thomas J. Bakas - Piper Jaffray & Co (Broker) Kristen M. Stewart - Deutsche Bank Securities, Inc. David L. Turkaly - JMP Securities LLC Matthew Mishan - KeyBanc Capital Markets, Inc. David R. Lewis - Morgan Stanley & Co. LLC Brian D. Weinstein - William Blair & Co. LLC Jason H. Wittes - Brean Capital LLC Ravi Misra - Leerink Partners LLC Anthony Charles Petrone - Jefferies LLC
Operator:
Good day, ladies and gentlemen, and welcome to the Quarter Four 2015 Teleflex Incorporated Earnings Conference Call. My name is Emma, and I'll be your operator for today. At this time, all participants are in listen-only mode. We will conduct a question-and-answer session towards the end of this conference. As a reminder, this call is being recorded for replay purposes. And now, I'd like to turn the call over to Mr. Jake Elguicze, who is Treasurer and Vice President of Investor Relations. Please proceed, sir.
Jake Elguicze - Treasurer & Vice President-Investor Relations:
Thanks, operator, and good morning, everyone, and welcome to the Teleflex Incorporated Fourth Quarter 2015 Earnings Conference Call. The press release and slides to accompany this call are available on our website, at www.teleflex.com. As a reminder, this call will be available on our website, and a replay will be available by dialing 888-286-8010, or for international calls, 617-801-6888; passcode 70373672. Participating on today's call are Benson Smith, Chairman, President and Chief Executive Officer; Liam Kelly, Executive Vice President and Chief Operating Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Benson, Liam and Tom will make some brief prepared remarks, and then we'll open up the call to Q&A. Before we begin, I would like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors made in our press release today, as well as our filing with the SEC, including our Form 10-K, which can be accessed on our website. The format for this morning's event will be similar to our prior conference calls with Benson providing a high-level overview of our quarterly results and an update on some key strategic initiatives. He'll then turn the call over to Liam, who will review our product line and geographic revenue results, provide updates with regards to recent GPO and IDN developments, new product introductions and regulatory approvals, as well as highlight an acquisition that was completed in the quarter. Following Liam will be Tom, who will review our fourth quarter financial results and share with you our initial financial guidance for 2016. And finally, we'll open up the call to Q&A. With that said, I'd like to now turn the call over to Benson.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Thanks, Jake, and good morning, everyone. Today, I'd like to start my prepared remarks by saying thank you to our shareholders. Throughout 2015, the management team of Teleflex have been emphasizing that our 2015 guidance was predicated on a very strong fourth quarter. We very much appreciate the confidence of our shareholders and the Teleflex team to do just that. We realized that our year-to-date results at the end of third quarter might have raised some concern about our ability to hit our full-year guidance. For example, our adjusted EPS at the end of the third quarter was only 1% ahead of our year-to-date prior adjusted EPS. That meant we had to have a 40% improvement over our prior fourth quarter in order to come in at full-year double-digit adjusted EPS increase. That may have seem like a pretty steep hill to climb, however, internally, we were able to see through a lot of the noise and felt very confident in predicting an exceptionally strong fourth quarter, not just on EPS but constant-currency revenue, gross margin, and operating margin as well. Looking back at 2015, we fully appreciate that from an external perspective, our quarterly results seemed lopsided. And there's a simple explanation to that. They seemed lopsided because they were lopsided. Generally speaking, the number of shipping days, changes in foreign exchange rates, general comparisons to the prior year's quarter and some unique product growth trajectories can have a significant impact on any given quarter and we saw many of those factors at their extreme in 2015. Fortunately, we do not expect to see the same degree of lopsidedness in 2016, but we will see some. In Q1 2016 in particular, we'll have two-less shipping days. We also expect to see the most unfavorable currency comparisons for the year in Q1 2016. However, in the remaining three quarters, we move into much more favorable territory. We'll have extra shipping days, much less negative currency comparisons and a growing impact from new products. My view is that our strong results in the fourth quarter put us in an excellent position for continued growth throughout our P&L in 2016. Since Liam and Tom will go into the numbers in more detail, I want to use my time to do a brief review of the past few years, as well as emphasize some particular highlights that I believe are representative of where we are headed strategically as a company. So, let's begin. Fourth quarter revenues were strong and they increased 7.4% on a constant-currency basis, totaling $484.5 million. We're very pleased to see the continued robust top-line performance from our Vascular, Surgical and OEM franchises. In addition, we're extremely encouraged to see the resurgence of revenue growth within our Anesthesia European and Asian businesses as well during the fourth quarter. We did benefit from an additional shipping day as compared to the prior year period, which we estimated contributed approximately 100 basis points toward our constant-currency revenue growth. We also had approximately 140 basis points from our M&A activities. If you would remove the additional revenues associated with the extra shipping day and any revenue attributed to M&A, we still achieved a 5% organic constant-currency revenue growth rate in Q4. These favorable fourth quarter numbers allowed us to deliver a full-year constant-currency revenue growth of 5.4% and further boost our confidence for 2016, as well in our ability to achieve the longer-term targets that we outlined in May of last year at our Analyst Day. Moving to some additional highlights. In the fourth quarter, we achieved adjusted earnings per share of $2.01. When compared to the prior year period, adjusted EPS was up approximately 41%. Two items in particular that I would like to mention that drove this earnings growth were the 54.1% adjusted gross margins and 23.7% adjusted operating margins that were accomplished in the quarter. These amounts, along with our adjusted EPS were the highest for Teleflex since transitioning through a pure-play medical device company. From a full-year perspective, our adjusted earnings per share reached $6.33. This was up 10.3% versus the prior year and was near the top-end of our initially provided 2015 guidance range. We were able to achieve this in-spite of an $0.87 currency headwind. This is a testament to the financial leverage we are generating throughout the P&L, including the initial benefits we obtained in the fourth quarter from our previously announced manufacturing restructuring plant. This plant, which was announced in April of 2014, remains on track. We continue to believe that we will achieve annualized pre-tax savings of between $28 million and $35 million and that will be substantially complete by the end of 2017. Furthermore, because of the progress we have made in this initial restructuring, the individuals responsible for these activities have now come to the point whereby they can begin to work on new opportunities to further optimize our cost structure. As such, this morning, we announced a new facility restructuring. Footprint consolidation announcements are never easy. And we make these decisions only after very careful consideration. Over the past several months, we have been evaluating opportunities to improve our operating leverage over a multi-year period and the plant we announced today is designed to further improve our competitive position. Similar to our prior plan, our new effort is focused on the consolidation of operations and will result in a reduction in workforce at certain of the company's facilities. It will include the relocation of certain manufacturing locations, as well as the relocation and outsourcing of certain distribution opportunities. We expect certain actions to commence in the second quarter this year, and that these actions will be substantially complete by the end of 2018. As I stated a few moments ago, we try to be thoughtful when making this decision. And it is our intention to speak with affected employees shortly. I realized this may be unsettling time for Teleflex employees as they hear the news of a new restructuring program. And I would like to thank all of our employees for their hard work and dedication. The circumstances driving this, though, were unavoidable. Everyone is concerned about the high cost of healthcare and we must improve our margins up to the level of our competitors in order to continue to grow. To those employees affected, you have my commitment that we will treat you in a fair manner as we proceed. This is not something that will happen overnight either. We currently expect that this plan will achieve annualized savings of between $12 million and $16 million once it is fully implemented. And it will start realizing at least some of the savings in 2017. As many of you are aware, we previously provided adjusted gross and operating margin targets to hit by the end of 2018. Specifically, those were that we would obtain between 350 basis points and 400 basis points of adjusted gross and operating margin expansion, as compared to our full-year 2015 levels. The annualized savings associated with this most recent restructuring plant were not part of the targets we communicated last May at our Analyst Day. However, at this point in time, we are not raising our margin goals for 2018. Here, we are simply being conservative to allow for the unexpected. However, we will periodically update the investment community with revised estimates in timing. I want to point out that at this time, all signs point to our ability to achieve that 350 basis points and 400 basis points of gross and operating margin without the synergies associated from this new plan. So, we're all quite optimistic that this will have an additive potential. Now, before turning the call over to Liam, I would like to briefly review some key highlights over the past few years. When this management team took over the helm of Teleflex in 2011, the company had sizable base of revenue but limited sources of sustainable organic growth, outstanding product pipeline and few acquisition targets. By the end of 2011, our full-year revenue was slightly under $1.5 billion, our adjusted gross margin was 47.6% and our adjusted tax rate was 26.3%. Our adjusted earnings per share were $3.83 and our market cap was approximately $2.5 billion. Fast forward to 2015, our revenue had accelerated to $1.8 billion, representing a compound annual growth rate of 5%. Our adjusted gross margin had expanded 510 basis points. Our adjusted tax rate has declined 950 basis points. And our adjusted earnings per share has grown at a compound annual growth rate of 13%, reaching $6.33. In addition, during the past few years, a combination of larger strategic acquisitions, late-stage technology acquisitions and distributor-to-direct conversions have played a significant part in Teleflex's ability to reshape our product portfolio, drive above the market revenue growth rates, and improve our margin and earnings profile. These items have resulted in significant shareholder value creation and a market cap at the end of 2015 of approximately $5.5 billion. I point all this out because I want you to know that this management team is dedicated to delivering improved patient care, while reducing the cost of healthcare around the world. We are excited about the opportunities we have in front of us to drive both margin improvement and revenue growth. We are not slowing down and remain as committed as ever towards additional shareholder value creation. That completes my prepared remarks. I will now turn the call over to Liam, and he will provide you with an update on our strategic business line results.
Liam Kelly - Chief Operating Officer & Executive Vice President:
Thank you, Benson, and good morning, everyone. For the consolidated company, fourth quarter 2015 constant-currency revenues grew 7.4%. Normalizing for mergers and acquisitions and an additional billing day in the quarter, our organic revenue growth was up 5%. Sales volumes of existing products were particularly strong domestically within our Anesthesia, OEM and Vascular businesses. Vascular sales volume increases were the largest as they were aided by the contribution of our Vidacare product lines, which grew approximately 25% versus the prior-year period, and sales of our CVC products continue to perform well. As a side note, on a full-year constant-currency basis, Vidacare product sales grew approximately 20%. I'm also pleased to confirm that the PICC product recall that we referred to in quarter two and quarter three of 2015 is now behind us. We continue to see strong growth in our core market, North America, with growth in the fourth quarter of over 8%. In addition to the volume growth we saw domestically, during this quarter, we also saw a return of volume growth within many of our international markets. Core product volumes improved approximately 360 basis points in Europe and approximately 1,000 basis points in Asia. (13:46) growth in Asia stemmed from an easier comparable in China. However, not all areas of the globe saw improvement as Latin America core product volumes were down in the fourth quarter. This is something that we expected to occur and signaled as much in our third quarter earnings conference call. Turning next to revenue growth from acquisitions and distributor go-directs. During the most recent quarter, revenue growth coming from these areas contributed approximately 140 basis points towards our overall constant-currency growth. This was consistent with the levels we saw in the third quarter and was driven by the acquisitions of Human Medics, Mini-Lap and Stenning. And while during the course of 2015, we did not complete another Vidacare or LMA-sized deal, we did put approximately $100 million of cash to use in the form of acquisitions, the likes of which added a little more than 1% towards our full-year constant-currency revenue growth rate. In addition to acquisition and go-direct, we also had approximately 1% of growth coming from new product introductions. New product sales were particularly strong within our OEM and Surgical businesses. In fact, during the course of 2015, we successfully introduced 20 new products and line extensions, and as Tom will share with you in a few moments, these already launched products are expected to be a catalyst for additional revenue growth in 2016. A few of the key product launches that occurred in 2015 are those that are expected to occur in the first half of 2016 include Protector, Mini-Lap, EFx Shield, ConchaTherm Neptune, Percuvance and pre-loaded PICC products. New products are a key component of our growth strategy as they provide sustainable multi-year growth, allow us to take share, enhance our growth margins, and identify Teleflex as an innovator in the marketplace. By way of example, Percuvance represents a market potential of $300 million to $400 million over a multi-year period. This would be accretive to Teleflex margins and is pure share growth, not cannibalizing any of our existing products. We recently completed the pre-market launch for this product. And of the 10 U.S. sites involved, nine have committed to proceeding through the value analysis committee stage with four having already added the product to their formulary following that process. We will go to full market launch in EMEA in quarter one and in North America in quarter two. Our LMA Protector is getting a similar response from its limited market release. All 11 U.S. hospitals which took part in the launch are now ordering the product. Finally, from a core product pricing standpoint, we saw the average selling price of our products expand a modest 10 basis points. This was primarily due to increases in surgical product pricing, somewhat offset by a decline in respiratory and EMEA product pricing. Next, I would like to provide some additional color surrounding our segment and product-related constant-currency revenue growth drivers. Vascular North America fourth quarter revenue increased 10.3% to $90.3 million. The increase in Vascular revenue was largely due to sales of central venous and catheter navigation products, as well as very strong business fundamentals exhibited from our Vidacare EZ-IO and OnControl devices. Moving to Anesthesia North America, fourth quarter revenue was $50.6 million, up 6.8% versus the prior-year period. Growth in this segment was driven by increased sales of Vidacare EZ-IO product, Airway Management devices and higher sales on our Atomization product offering. Turning to our Surgical North America business
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Thanks, Liam, and good morning, everyone. Even the previous discussion of the company's revenue growth drivers, I'll begin my prepared remarks at the gross profit line. But before I do, I'd like to reinforce the point made earlier by Benson, which is that 2015 was a tremendous year for Teleflex, including a strong final quarter to close out the year. Full-year 2015 constant-currency revenue growth of 5.4%, and adjusted earnings per share of $6.33 were both at the upper end of our initially provided 2015 guidance ranges. Additionally, our North American businesses continue to perform well with our higher-margin Vascular and Surgical franchises, each delivering full-year constant-currency revenue growth in excess of 8%. Our business in Europe remained relatively stable. And while emerging market softened a bit, they do not comprise a significant part of our global revenue, thereby mitigating downside risk. Despite currency taking a 700-basis point bite as our 2015 revenue growth, we were able to leverage a 1.6% decline in as-reported revenue into a 12.6% increase in adjusted net income. We accomplished the financial leverage through expansion of both our gross margin and our operating margin. And by taking steps to further reduce our effective tax rate and optimize our capital structure. Also during the year, we acquired and integrated several smaller businesses and continued the execution of our facility restructuring plan. Clearly, 2015 was a good year for Teleflex. Turning now to fourth quarter results. For the quarter, adjusted gross profit was $262.2 million versus $243.1 million in the prior year quarter. Adjusted gross margin was 54.1%, representing a 300 basis point increase when compared to the prior-year period. During the fourth quarter, adjusted gross margin benefited from manufacturing cost improvement programs, distributor conversions, acquisitions and new product introductions. Additionally, we realized the benefit of volume throughput as well as favorable product mix in our Respiratory North America, Anesthesia North America, and Asia segments. During the quarter, foreign exchange negatively impacted our gross margin by approximately 25 basis points. Also in the fourth quarter, adjusted operating margin improved by 530 basis points. The increase was largely the outcome of the gross margin gain, continued tight control over discretionary overhead spending and a favorable prior-year SG&A comparable. For the quarter, adjusted operating profit and margin were $114.8 million and 23.7% respectively versus $87.5 million and 18.4% respectively in the prior year quarter. On a sequential basis, operating margin increased by 250 basis points from the third quarter of 2015. If you were to normalize our results to exclude the impact of currency, adjusted operating margin in the fourth quarter would have been approximately 100 basis points higher. Continuing down the income statement
Operator:
. Okay, the first question comes from the line of Larry Keusch of Raymond James. Please proceed.
Lawrence Keusch - Raymond James & Associates, Inc.:
Hi. Good morning, everyone.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Good morning, Larry.
Liam Kelly - Chief Operating Officer & Executive Vice President:
Good morning, Larry.
Lawrence Keusch - Raymond James & Associates, Inc.:
Good morning. So, for Benson or for Tom, just on the announced manufacturing footprint consolidation, I think if I just do the very high-level math, it's sort of 70 basis points or so benefit to gross margin. And I recall that in totality, you had anticipated that there were items that could improve gross margins by maybe 300 basis points, 350 basis points. So, when I add the two programs together, you're probably 250 basis points, somewhere in that range. So, A, I want to check and see if that math still holds and then if there are still further opportunities to improve the gross margin.
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, this is Benson, Larry. Your math is correct and the right assumption around that is that even including the second phase which we've announced does not represent the total sum of our footprint consolidation opportunities. As we did with the first phase, we've made the decision that the least risky way to proceed here is to do this in a phase effort. So, we are still confident about the overall sum that we'll get from footprint consolidation and you are right that there's more on the table than what is represented by these first two plants.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. And then just on that point, just as we think about the gross margin expansion for 2016, are there, as we think of it through the year, are there any inflection points or specific events that occur that might cause a step up or is it sort of ratable through the year? Just any help as we think about that would be great.
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, Tom and I both talked a little bit about the first quarter with two less shipping days that is going to have a volume impact to us of at least 2%. Volume is a component of what drives gross margin and our expenses don't go down as a result of those two less shipping days. So it has an impact on operating margins as well. Excluding just the impact of first quarter as a result of the two less shipping days, it's going to be essentially ratable through the second quarter, third quarter and fourth quarters. A little more heavily weighted towards the fourth quarter, but not substantially so as the new products we're introducing have higher margins.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Terrific. Thanks very much guys.
Operator:
Okay. So, the next question comes from the line of Brooks West of Piper Jaffray.
Thomas J. Bakas - Piper Jaffray & Co (Broker):
Tom on for Brooks.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Good morning.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
(41:19)
Thomas J. Bakas - Piper Jaffray & Co (Broker):
Morning. I just wanted to start with M&A. You guys did some smaller deals in 2015. But I'm wondering just, if you're seeing the environment change given the change in valuations and valuation expectations, if that might impact a potential larger deal in 2016 and just sort of – some high-level comments in the M&A pipeline.
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, the clearest answer I can give you is that we remain absolutely committed to continue to do Vidacare and LMA-size and type acquisitions. It's very hard to give any clearer guidance in that since we can't announce something until the deal is essentially consummated from an agreement on both our parts. The overall, I would say the overall market environment has been a little affected by increased valuation expectations. But we still look for those opportunities where – because of the synergies we're able to bring to the table, we're the most likely buyer. So, that's – I wish I could provide more clarity, but we continue to remain committed. We have a very active identification list of companies that we have an interest in. And at the very least, I think you can expect a continued deployment of capital at the level we did in 2015 on those smaller acquisitions.
Thomas J. Bakas - Piper Jaffray & Co (Broker):
Okay. Great. Thanks. And then just one more if I may. There's a nice tick-up in revenue in Asia, or the growth rate there this quarter. I'm wondering how sustainable that is, and if that's just the function of – I guess just a little more color on that would be helpful.
Liam Kelly - Chief Operating Officer & Executive Vice President:
So, we did have a good – it's Liam here. We just have a good comparable in the fourth quarter as we outlined during our quarter three earnings call. And for 2016, as we've said, we expect in the high-single-digit growth out of APAC and that will be our expectation. The pickup in China was pretty solid in the fourth quarter. And our overall Asia growth was 18%. China for sure was accretive to that. Our overall business as we go direct, places like Australia become a bigger part of the overall APAC numbers. So just as a term of reference, you don't get the double-digit growth out of place like Australia as you would out of China, Southeast Asia, for example. So high-single digits is our expectation out of Asia in the coming year.
Thomas J. Bakas - Piper Jaffray & Co (Broker):
Thanks, guys.
Operator:
Next question comes from the line of Kristen Stewart of Deutsche Bank. Please proceed.
Kristen M. Stewart - Deutsche Bank Securities, Inc.:
Hi. Thanks for taking the question and congratulations on the results. I was just wondering if you could actually comment on the broader, just kind of dynamics as you see them, just across the different geographies. I know that you had been expecting some weakness within Latin America. Maybe if you could just comment on what you're seeing more broadly just across like North America, in the U.S. in particular.
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, North America, we continued to see robust growth and expect that to continue into 2016. Of our major business franchises, the one that was at the low end of the scale was our Anesthesia business throughout three quarters of 2015. We started to see a nice pickup at the end of 2015 in the fourth quarter and expect that to continue. We do not expect any negativity in U.S. results stemming from the ACA and haven't seen any evidence that that's likely to be the case for our particular product portfolio. Other device companies may have more exposure there. Latin America certainly continues to be a problematic area for us as a result of the low prices for oil revenue. We have, looking at our 2016 guidance, discounted much growth from that area so we don't see any vulnerability there. But we certainly don't see the situation improving. Liam?
Liam Kelly - Chief Operating Officer & Executive Vice President:
I'll just add a little bit of color to that, Kristen. If you look at what happened in North America through Q2 to Q4, we went from 4.3% to 5.6% to 8.2%. Now, there are some billing days moving there, but nonetheless progression. And in particular, in Latin America and in particular, in regard to Venezuela, we have very little recovery forecast for Venezuela in our 2016 numbers.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Europe, we have characterized as stable. We have a good organization in Europe so I think that we'll probably see some modest uptick even in a stable environment there. And Liam has commented on Asia. So, I think the sum total is, more of what we've seen in the latter half of 2015, are the trajectories we expect to see in 2016.
Kristen M. Stewart - Deutsche Bank Securities, Inc.:
Okay. Then – sorry if you had already addressed this, but just in terms of medical device facts, are you guys reinvesting that back into the business? And if so, where are those investments going back? Is it more of the marketing? Is it more for R&D?
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, the answer to the question, it's primarily being reinvested. We went through a list of internal projects that we wanted to fund this year and our total increase in R&D spending is up about $10 million to $12 million. So, that's about the number that we save from the medical device tax. In terms of where it's going, we're advancing some of our efforts in terms of our MAD Nasal product that requires some regulatory approvals. And we're expanding our Clinical Education group in order to get more mileage out, and we have withheld a little bit of that for some cushion for FX. If we learned anything over the past few years, is nobody seems to know exactly what the currency is going to be in a given year. So, we thought that was prudent to protect ourselves from the downside if FX turns out to be a little bit more negative than we thought it was.
Kristen M. Stewart - Deutsche Bank Securities, Inc.:
Okay. Great. Thanks very much.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Thank you, Kristen.
Operator:
Next question is from the line of Dave Turkaly of JMP Securities. Please proceed.
David L. Turkaly - JMP Securities LLC:
Thanks. Looking at your biggest business in North America, Vascular leading the way in growth this quarter. I mean, I know, we've been monitoring sort of Vidacare and how that's done, but any color in terms of share gains or anything else you'd point to there? And then, looking forward, do you think this is sustainable, that this could be sort of the leading growth division of Teleflex in 2016?
Liam Kelly - Chief Operating Officer & Executive Vice President:
So, I'll take this. It's Liam here. So, you're right to point that Vidacare – obviously, Vidacare, over the year, grew by 20%. So, that's a part of the story. Also on our CVCs, if you look at our CVC growth globally, that was in the mid- to high-single digit. CVCs were up close to 7% in that timeframe. And also, we see nice opportunity in PICCs. And now that we have the Chlorag+ard PICC with the positioning systems that we announced on the call today, we think that puts us in a very strong position to address the areas of thrombus and infection with our products. So, we see this as sustainable for sure. We don't see any reason why Vidacare growth would soften. We continue to see opportunities to expand within our CVC and we see, in particular, growth opportunities within our PICC portfolio, and we see Vascular continuing the trend in 2016 and beyond as it did in 2015.
David L. Turkaly - JMP Securities LLC:
Thank you for that. And then...
Liam Kelly - Chief Operating Officer & Executive Vice President:
So, we made it sustainable. We made it sustainable.
David L. Turkaly - JMP Securities LLC:
I appreciate that. Thank you. And just for those of us that – recall the VasoNova deal and the position system, now, you're adding Nostix. I guess that we think of that as – you mentioned affordable for Nostix, is it a similar technology that's at a lower price point that you're going to use? And you really – can you really sell these both in the same hospitals? I guess I'd just love a little more clarity on how you're going to put those two together or how they sit together?
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, I would say there's more of an international interest in the Nostix product. Once you go outside the United States, most PICCs are placed by physicians particularly in Europe. They are more than capable of reading the ECG wave and making the determinations where the catheter is. So they're reluctant to pay a premium to have a simplified bull's eye system that is almost an insult to their clinical capability. So, this really enables us to provide a more cost-effective system that's very directly competitive with the largest competitor out there. And also, I think importantly, allows us some future potential to develop targeting systems that will work with CVC catheters and hemodialysis catheters. So, we still see our VasoNova system at the high end and most accurate system available, we're really delighted that we now have a VasoNova stylet that can work with our Chlorag+ard PICC products. So now customers don't have to choose between targeting and infection control and we can wrap that out. So, we see a strong rationale for good, better, best strategy. And it's the same thing we're doing with LMA masks in terms of a low-cost, mid-cost and high-cost alternative.
David L. Turkaly - JMP Securities LLC:
Thank you very much.
Operator:
Next question comes from the line of Matthew Mishan of KeyBanc. Please proceed.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Good morning. And thank you for taking my questions.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Good morning.
Liam Kelly - Chief Operating Officer & Executive Vice President:
Good morning.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Good morning, Matt.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Hey. I believe you said that 9 out of the 10 initial customers that were testing Percuvance committed to the product after the evaluations. Could you give us a sense of how they're progressing moving forward? I'm assuming you had some early adopters in the hospital testing the product. Are they the ones moving forward or are they now migrating it across the hospital through larger training programs?
Liam Kelly - Chief Operating Officer & Executive Vice President:
So, what's happening at the moment is the 10 that were part of the trial, as I said in my prepared remarks, 9 have moved forward. Four of them have already added as the formulary and the others are going through the value analysis committee. And as you know, going through the value analysis committee can take anything from three to six months depending on the questions being asked. The product is broadening within those institutions and we have another 15 institutions that are waiting to trial the product and to go through the exact same process. So we're broadening of beyond the early adopters, Matt, to answer your question. And we are broadening into a greater sphere of customers. The same approach we're taking in EMEA. We got the CE mark, so we're all set to go with our launch within EMEA in quarter one. Everything we continue to learn about the products keeps us highly enthusiastic about its long-term potential.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
And of the 200 basis points to 250 basis points of growth, how much of that are you attributing to Percuvance this year?
Benson F. Smith - Chairman, President & Chief Executive Officer:
In 2016, it's very little, very little. As Liam said, we've only been in 10 accounts at this point in time. We will be expanding that number during the course of the year. But it does take between three months and six months to get to the value analysis committees.
Liam Kelly - Chief Operating Officer & Executive Vice President:
And if you wanted to look, Matt, at our minimally invasive package, you would look at that at about 50 basis points to 60 basis points between our minimally – that includes Percuvance and Mini-Lap.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
All right. Thank you very much.
Operator:
Next question comes from the line of David Lewis of Morgan Stanley. Please proceed.
David R. Lewis - Morgan Stanley & Co. LLC:
Good morning.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Good morning.
Liam Kelly - Chief Operating Officer & Executive Vice President:
Good morning, David.
David R. Lewis - Morgan Stanley & Co. LLC:
A couple of questions on guidance, one for Tom, one for Benson. I guess, Tom, the first question is, as you're probably aware, the last four years, your fourth quarter margin is always lower than your third quarter margin. Obviously this year, it was the opposite of that. So, what I can figure out with guidance is, your guidance basically implies no improvement in gross or operating at the low-end of the range of the four quarter level. Just given the progression of cost restructuring, how is that possible? And then I have a quick follow-up on organic growth.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Well, when we look at our gross margin, we're not perhaps as focused on any one particular quarter because there can be pluses or minuses that happened. We're really looking at the longer-term kind of growth of a year or multiple years. And so as we look at the fourth quarter, it's a quarter that had very, very significant volumes and that created some significant leverage for us. As we look at the year overall, we're seeing a nice progression in 2016 relative to 2015 and there's a number of drivers behind that and we pointed to a number of them in the prepared remarks. First of all, the footprint consolidation. The first phase of that will actually begin delivering some meaningful savings in 2016 of about $15 million. Overall, we expect footprint consolidation to contribute kind of a third or so of the overall growth in margin. We also are showing some nice operations efficiencies which were offsetting our inflation and that's driven by a number of initiatives, including SIPS (55:54). We've got strategic procurement initiatives and that collectively is about another 10% of the total growth. And then we've got some one-off expenses that we incurred in 2015 that we expect to go away or mitigate in terms of size and that will drive another 20% of the total improvement in gross margin. Now, in addition to the kind of cost savings on manufacturing, commercial volume and mix is going to be a nice driver for us. So we're going to continue to see margin gains coming from higher-margin products such as Vidacare, introduction of new products. We've got some product rationalization going on across the company. And then we've got a little bit from pricing. In addition, we've got some minor amounts of margin gain from M&A and distributor conversions included in the mix. So, I wouldn't focus particularly on one particular quarter but rather look at the trend and what we see is a nice progression in 2016 relative to 2015 for the reasons just mentioned.
Liam Kelly - Chief Operating Officer & Executive Vice President:
Yeah. I think, David, maybe the implication of your question is isn't that full-year guidance even at 54% to 55%, a little on the conservative side? And you're exactly right, it's a little on the conservative side.
David R. Lewis - Morgan Stanley & Co. LLC:
Okay. That was my point. You made a good point about you've got to 54% in the fourth quarter and that only mean something if 54% is the new high watermark, I guess, was the point I was trying to make. And, I guess, number two, on organic growth, same question. You sort of delivered a 5% organic number in the fourth quarter. Your guidance implies something close to the 4.5% to 5.5% for 2016. So, 5% the midpoint. And just given the PercuSurge opportunity in 2016 as well as the LMA opportunity, can you talk about factors that will result in organic growth being lower, frankly, in 2016 in the fourth quarter? Thank you.
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, again, if we take out the impact of the full-year of acquisitions, that's 140 basis points in the fourth quarter, which comes out and the extra shipping day 1%. So, that leaves us at about 5%. When it comes to 2016, we have only included in our guidance those elements from the smaller acquisitions that have a high – that are either already closed or have a very high probability of closing over the next few months. The likelihood that we do more than that in 2016 is certainly probable. So, and the 2015 number, obviously, includes everything that we did during the course of that year. So, that leaves some conservatism I think in the overall numbers as we look at that 5% to 6%. I think the main point that we're trying to get, there's been a lot of conversation about what does our growth look like without acquisitions is fourth quarter we'd certainly have – I think, have a clear demonstration that we're certainly right at around that 5% number without any assistance from acquisitions.
David R. Lewis - Morgan Stanley & Co. LLC:
Okay. Very clear. Thank you very much.
Operator:
Next question comes from the line of Brian Weinstein of William Blair. Please proceed.
Brian D. Weinstein - William Blair & Co. LLC:
Hey, guys. Good morning. Thanks for taking the question.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Good morning, Brian.
Brian D. Weinstein - William Blair & Co. LLC:
My question is on emerging markets. I think you mentioned in one of the slides, decreased investment there. Can you be more specific about where you're decreasing investment, what it's around? And is this a permanent reduction or is this kind of hitting the pause button for right now?
Liam Kelly - Chief Operating Officer & Executive Vice President:
As we think about where to deploy resources in any given year, we think about where the growth opportunities are. And if you look back a couple of years, we saw some nice growth across Asia and China and other markets and we upped the investment there to increase our sales penetration. For now, we're not continuing to up the level of investments that we had in the past. But just to be clear, we're not looking to scale back and exit markets, but rather just to divert resources to where we see some of the greatest growth. And right now, we see good growth in the U.S. and we see good opportunities behind some of our new product offerings, including Percuvance, Mini-Lap and as well as Vidacare where we're going to continue to divert resources to develop those potential opportunities. So again, it's not as if we're exiting any markets, but rather just curtailing the level of increase in those markets.
Brian D. Weinstein - William Blair & Co. LLC:
Okay. Great. And then on GPOs, you guys constantly talk about significant wins there. But how should we think about? And just broadly speaking, how do you think about what those GPO wins actually translate to in terms of revenue contribution over a period of time? And you mentioned the wins, but are there any GPOs that you guys are losing? So net-net, I know you're up, but is there anything that you guys were not successful with this year when it comes to GPOs?
Liam Kelly - Chief Operating Officer & Executive Vice President:
Well, within our numbers that we have two contracts that we locked, with neither of them were that significant. But adding to the wins that we announced, it's a small lost versus the significant win. If we look at the contribution of GPOs and IDN agreements, obviously there is a significant part of our growth rate. And if you look at the fourth quarter in North America and you look at the 8.4%, and you look at the full-year which is 6.2%. And if we look at the full-year, there is no billing days movement in that the 6.2%. We're getting about 1% to 1.5% growth from the market. That's what we estimate we're getting from procedure growth. So, everything above that is share gain and obviously, our GPO and IDN strategy is the key component of that. And we see that as a sustainable long-term. It also points to the point that Benson makes many times about our size. We are of sufficient size to be meaningful to the GPOs and the IDNs where we have significant share in segments of the marketplace that allows us to go in and extend our contract rates with those customers. If you look at where our products are used, they're used primarily in large urban sophisticated healthcare institutions. They're not used in smaller rural hospitals. Virtually, all of those hospitals are either – their purchasing is either supported through a GPO or an IDN arrangement. So, without those agreements, it is very difficult for a sales person to get a hospital to shift over into a non-contracted product. So, they're an important part of our strategy to set the stage for us to be able to have product discussions in those accounts.
Brian D. Weinstein - William Blair & Co. LLC:
Great. Thank you, guys.
Operator:
Next question comes from the line of Jason Wittes of Brean Capital. Please proceed.
Jason H. Wittes - Brean Capital LLC:
Hi. Thank you and good morning.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Good morning.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Good morning.
Jason H. Wittes - Brean Capital LLC:
I just wanted to ask, you guys have done a tremendous job in sort of brining your growth rate up to sort of I think what was your original target of 5% to 6%, which is sort of the upper end of hospital supply names. However, if I look at your outlook, you're still benefiting from some slight positive pricing pressure, which, compared to some of your peers, is actually – they're normally seeing pricing pressures. I'm sorry, you're seeing price increases and they're seeing pricing pressures. So, I'm wondering if you think that over the long term 5% to 6% is still the right number, especially as pricing sort of becomes more reflective of some of your peers, or if pricing – when pricing starts to become a more negative impact that it's a lower outlook than the 5% to 6% that we're seeing sort of for 2016 for organic growth.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Yeah. So, in 2016, we're only counting on 10 basis points to 20 basis points coming out of pricing. And I would characterize that as, again, a relatively conservative approach. Our real longer-term strategy is actually to move as much of our product portfolio into product categories, which don't have the same pricing targets on their back. So, Vidacare is a great example of a product, where there's really no significant competition. Products like Chlorag+ard – as a coating for both PICCs and CVCs really doesn't have much competition. So, we think in many ways, we're better protected against a very extreme cost environment that we might be moving into. And we still have the opportunity of dealer and distributor conversions, which show up in pricing, but we tend to think of them more as an acquired opportunity. All of which is helping our margin. But you're right, we have not seen the same negative price elements that other device manufacturers have had. But we've paid a lot of internal attention to pricing on every product code up and down the catalog.
Jason H. Wittes - Brean Capital LLC:
Okay. That's fair. And then, I think last year, you did actually call out that there would be some distributor conversions. This year, you're a little less – I guess, you're a little more opaque about it. I mean, should we expect some this year or is it just depending on how the year progresses, et cetera?
Benson F. Smith - Chairman, President & Chief Executive Officer:
So I'll go back to my earlier comment that I made to a question and that is that our revenue guidance assumes only things that were closed in or are...
Jason H. Wittes - Brean Capital LLC:
Okay.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Our revenue guidance assumes things that are largely closed. There are certainly elements to where we think that we'll do better than that and we did better than that in 2015. So we don't expect a slowing down. It's just that that's not in our 5% to 6%.
Liam Kelly - Chief Operating Officer & Executive Vice President:
If I could just add to that, if I look at the environment for dealer to go-direct. And we've said in the past, you can expect to see the same level of dealer-to-direct between 16% and 18%, as you've seen in the past, and we would be consistent with that. The environment is still rich there for us to do more dealer-to-direct. We just don't have them in our guidance numbers because we only have in our guidance numbers the ones that are closed.
Jason H. Wittes - Brean Capital LLC:
Okay. That's helpful. And then, I believe, you said the LMA Protector was going to be one of the drivers this year, if I heard correctly. I know that you were doing some work to extend the label beyond two hours for that with some data collection I think you did last year. Has that concluded, and is the new label improved from what it had been in the past?
Liam Kelly - Chief Operating Officer & Executive Vice President:
That work is not concluded. That work is as part of our launch because in order to make any change to the label, we need to make a 510(k) submission to the FDA. And as part of our launch, we are actually working with our customers to gather the data that would sustain such a submission. I wouldn't want you to anticipate that the Protector has a massive impact on our new product portfolio. From a new product revenue generation, it is. We're rolling it out in a limited market release, and we continue to roll it out slowly and steadily to our customer base, in particular in North America, Australia and Europe and the UK where we have significant users of the laryngeal mask and in particular, on the second generation. And we'll use those customers to gather the information for the submission. What I should have said was the UK in the European Union, so.
Jason H. Wittes - Brean Capital LLC:
Okay. That's helpful. And I mean, assuming that you can extend the label, could we expect more significant growth from the product? I mean, is that a major milestone to look for?
Liam Kelly - Chief Operating Officer & Executive Vice President:
Well, in the future, we're quite optimistic that once we get the change in the label, we should be able to move more of the endotracheal tube market over. Just to give you a reference point, the endotracheal tube market globally is about a $150 million market. Sales price of an endotracheal tube is $1 to $2. The sales price for a second gen or a Protector is in the region of $16 to $25. So, once we get that indication, obviously, and some of our customers that have used the product have told us that they believe that that indication should be within line of sight. But we need the clinical data to support that.
Jason H. Wittes - Brean Capital LLC:
And I guess last question on this, is there an expectation that sometime in 2016 you would be able to have the data collected and potentially submit or any kind of timeline you could provide on when we should anticipate that?
Liam Kelly - Chief Operating Officer & Executive Vice President:
We would expect to collect the data during 2016 and do the submission sometime in 2017.
Jason H. Wittes - Brean Capital LLC:
Okay. Great. Thank you. Very helpful. Thank you.
Operator:
Next question comes from the line of Richard Newitter of Leerink Partners. Please proceed.
Ravi Misra - Leerink Partners LLC:
Hi. Good morning. This is Ravi in for Rich. Can you hear me okay?
Liam Kelly - Chief Operating Officer & Executive Vice President:
Yes we can.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Yeah. Good morning, Ravi.
Ravi Misra - Leerink Partners LLC:
Thanks for taking the questions. Good morning. So, just one question on the guidance and then one on the restructuring if I could. The 20 bps to 30 bps from previous M&A, if you could give a little bit more clarity around what you consider previous M&A. I mean, if I apply that to just Vidacare, I'm looking at Vidacare growth of about 5% in 2017. That seems a little bit low versus what we were thinking. Is that the right way to think about it? And then on M&A, understandably it seems you're being conservative on the gross margin and operating margin potential. I'm sorry, not M&A, restructuring, on the $12 million to $16 million savings. Now, is that – do you see some portion of that realized, or what's reasonable for 2017 realization and understanding that, is that going to be mostly in gross margins? And if so, the – moving around the manufacturing facilities, could that have a benefit on your tax line? Thank you.
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, let me talk about how we view M&A. we only count M&A as M&A revenue for the first 12 months that we've acquired the product. So, Vidacare has already passed its 12 month number. So, once that happened – in fact I think it passed it in January of 2014.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
(70:16)
Benson F. Smith - Chairman, President & Chief Executive Officer:
Yeah. So, that wasn't – that had – really didn't have impact in our 2015 numbers and no impact in our 2016 numbers. And Vidacare continues to grow substantially. As Liam said, the growth in – for the year was 20%. So, these constantly expire. We obviously still get benefit from acquisitions long after they're – long after we count them as M&A growth. But quite frankly, the reason Vidacare is growing is because we're putting a lot of sales energy in clinical education around it. Most of the acquisitions that we're talking about having an impact in 2016, again, just to reiterate what I said a few minutes ago, are things that have already closed; they tend to be relatively minor in nature and collectively, are going to produce that 20 basis points to 30 basis points. Do we expect the year to finish stronger than that? Our history suggests that that's the case. We continue to remain committed to both the smaller acquisitions and larger acquisitions as well. And excuse me, I forgot the second part of your question, if you could repeat that?
Ravi Misra - Leerink Partners LLC:
Sure. Thanks for the clarity on that. It was just around the restructuring, should we consider most of this in gross margins, given the comments on facility consolidation? And then second thing is, is there a potential tax benefit as you look to relocate plants, that's not contemplated in that number?
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
So, the savings would be in the gross margin line and taxes could see some minor benefit, but not a meaningful change to the guidance that we've got out there for 2016.
Ravi Misra - Leerink Partners LLC:
Great. Thank you.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
And then just to further the point on M&A. So, just for clarity, it is past 12 months, what's included in there, as I mentioned in my prepared remarks, is we've got Truphatek, an OEM acquisition and then Nostix. The Truphatek and OEM probably were closed in the second quarter of last year. So, we really only have a quarter of additional growth in this year. Then we had two distributor conversions included in M&A. And again, it closed early in 2015. So, the incremental kind of M&A impact with 2016 is very minimal. And that's why it appears to be on the lower end of the range.
Operator:
The next question comes from the line of Anthony Petrone of Jefferies. Please proceed.
Anthony Charles Petrone - Jefferies LLC:
Thanks. Maybe a follow-up on restructuring, Benson. Can you maybe walk through the prior programs and maybe this new 2017 program? If indeed there's any product divestitures that are included in there and maybe a quick follow-up after that?
Benson F. Smith - Chairman, President & Chief Executive Officer:
So there's no product divestitures that are included in that per se. We are typically always engaged and looking at minor segments of our product line that either should be harvested or, in many cases, they're even too small to be divested, but what essentially that does not play into the restructuring element at all. The first restructuring effort, most of the savings, although, there were other small plants involved. Most of the savings came from a relocation from our Vascular product line manufactured in Asheboro to Chihuahua. We are in the final stages of that, so we expect to start to see some benefit of that starting to kick in at the end of 2016 and more substantially in 2017. The second stage of restructuring since we haven't made our employee announcements yet, we're not in a position to be able to give much detail until we do that. But similarly, it's steered around moving product from high-cost labor areas to low-cost labor areas where we already have plants and facilities in place and their principal savings comes from the hourly labor rate and the overhead cost.
Anthony Charles Petrone - Jefferies LLC:
That's helpful. And maybe shift over to M&A. I mean when you look at sort of the strategy it's been adding the Vascular, Surgical and Anesthesia. Is that still the strategy here or would the company be open to a new vertical? And sort of a follow-up to that would be just a recap for Tom where the debt ratio is today and how high the company would be willing to bring that debt ratio up in order to facilitate a larger deal.
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, I'll let Tom talk about the debt ratio.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Okay. Well, in terms of our leverage per our credit facility definition, we're at 2.4 times at the end of the year and we have the ability to go up to 4 times under our current financing arrangements. Now, we've talked previously about our willingness to go up to 3.5 times. So, long as there is a pathway to get back to what we consider to be a longer-term target of 3 times. So, we've got ample capacity from a leverage standpoint to do additional acquisitions. We've also got cash on the balance sheet of over $300 million.
Benson F. Smith - Chairman, President & Chief Executive Officer:
And to answer your question, our preference is certainly to look at product areas where we have an existing sales force that can sell the product and is already making a call on the existing customers. In some cases, our own product development efforts lead us into some different areas, Percuvance for example will have a substantial opportunity within the gynecological market as well as other laparoscopic markets. But that opens the door for example for us to have additive products that get use by that same customer. So, we are opened to the idea of adjacencies as long as they're strategically consistent with where we want to move our product line in any way.
Anthony Charles Petrone - Jefferies LLC:
That's helpful. And last one real quick, would just be – I believe you had some recalls in a facility a couple of quarters ago, I believe in Vascular, specifically within PICCs. I'm just wondering if that is kind of cleared up. And if it is, what sort of kind of growth boost do you get from that, bringing those products back in?
Liam Kelly - Chief Operating Officer & Executive Vice President:
So, I'll answer that. As I said in my prepared remarks that the PICC product recall is behind us in Q4. So, we saw the recovery in Q4 of our PICC products. As we start to go back to those customers, we expect to see that rebound continue in Q1 and Q2. It does take a quarter or two because those customers will have stocked up with a competitor product. What we're hearing from the marketplace is that the most of them, if not all of them, will come back to us, that's very high percentage, are moving back to our product. But it just takes a while to restock, and we saw a mid-single-digit pickup in the first – in the fourth quarter. And we expect to see that accelerate through Q1 and Q2. Just on recalls, just in 2015 versus 2014, we saw our recalls numbers have from 44 to 22. So, even though they did have a bigger financial impact, the overall number of recalls would indicate that our processes are improving and our quality system is getting better.
Anthony Charles Petrone - Jefferies LLC:
Thank you.
Operator:
I would now like to turn the call over to Jake for closing remarks.
Jake Elguicze - Treasurer & Vice President-Investor Relations:
Thanks, operator, and thanks for everyone that joined us on the call this morning. This concludes the Teleflex Incorporated fourth quarter 2015 earnings conference call.
Operator:
Thank you for your participation in today's conference. This concludes the presentation. You may now disconnect. Good day.
Executives:
Jake Elguicze - Treasurer & Vice President-Investor Relations Benson F. Smith - Chairman, President & Chief Executive Officer Liam Kelly - Chief Operating Officer & Executive Vice President Thomas E. Powell - Chief Financial Officer & Executive Vice President
Analysts:
Lawrence S. Keusch - Raymond James & Associates, Inc. Kristen M. Stewart - Deutsche Bank Securities, Inc. Matt C. Taylor - Barclays Capital, Inc. Jonathan Demchick - Morgan Stanley & Co. LLC Matt Mishan - KeyBanc Capital Markets, Inc. Jason H. Wittes - Brean Capital LLC Anthony Charles Petrone - Jefferies LLC Ravi Misra - Leerink Partners LLC David L. Turkaly - JMP Securities LLC
Operator:
Good day, ladies and gentlemen, and welcome to the Q3 2015 Teleflex Incorporated Earnings Conference Call. My name is Mark, and I'll be your operator for today. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. As a reminder, this conference is being recorded for replay purposes. I would now like to turn the conference over to your host for today, Jake Elguicze, Treasurer and Vice President of Investor Relations. Please proceed, sir.
Jake Elguicze - Treasurer & Vice President-Investor Relations:
Thank you, operator, and good morning, everyone, and welcome to the Teleflex Incorporated Third Quarter 2015 Earnings Conference Call. The press release and slides to accompany this call are available on our website, at www.teleflex.com. As a reminder, this call will be available on our website, and a replay will be available by dialing 888-286-8010, or for international calls, 617-801-6888; passcode 53575576. Participating on today's call are Benson Smith, Chairman, President and Chief Executive Officer; Liam Kelly, Executive Vice President and Chief Operating Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Benson, Liam and Tom will make some brief prepared remarks, and then we'll open up the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in this conference call will contain forward-looking statements regarding future events as outlined in the slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors made in our press release today, as well as our filing with the SEC, including our Form 10-K, which can be accessed on our website. The format for this morning's event will be similar to our prior conference calls with Benson providing a high-level overview of our quarterly results and an update on some key strategic initiatives. He'll then turn the call over to Liam, who will review our product line and geographic revenue results, provide updates with regards to recent GPO and IDN developments, new product introductions and regulatory approvals, as well as highlight an acquisition that was completed in the quarter. Following Liam will be Tom Powell. And Tom will review our third quarter financial results and provide an update regarding our financial guidance for 2015. And finally, we'll open up the call to Q&A. With that said, I'd like to now turn the call over to Benson.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Thanks, Jake, and good morning, everyone. To start, we view our underlying business fundamentals for the third quarter to be healthy and as a result, this boosts our confidence in a robust fourth quarter and our confidence in our longer-term goals outlined in May. Since Liam and Tom will go into the numbers in significant detail, I want to use my time to emphasize some particular highlights. We were pleased to see that revenue growth this quarter was particularly strong within our key North American franchises of vascular access and surgery, each of which generated their highest constant currency growth rates of the year. In addition to these areas, we also saw a year-over-year and sequential constant currency growth rate improvement from our Anesthesia franchise. Our Anesthesia is still low by comparison to these other two franchises, but we fully expect to see continued improvement in our Anesthesia business as we focus more resources on higher margin, higher gross products, such as MAD Nasal and pain pumps. Additionally, just this week, we launched the LMA Protector in the United States and we're quite gratified by the positive reception received at the Anesthesiology Meeting. As you might remember, our general revenue growth thesis for our three-year plan anticipates continued growth in the North American markets. These favorable third quarter numbers give us confidence as we exit the year and further support what we have been saying for the past few quarters now, which is that the North American healthcare market is improving and more importantly, the Teleflex is taking market share. In addition to strength in North America, we also saw a return to double-digit constant currency revenue growth within our Asia segment. And this was despite the fact that growth in China was not as robust as it was several years ago due to that country's economic issues. Revenue growth generated from Asia this quarter was broad based was comprised of our continuability to increase the average selling prices of our products within the local markets, this exceptional integration of acquisitions and distributor conversions, and an improvement in underlying volumes in areas like Southeast Asia. However, during the third quarter, not all of our businesses in regions performed at their peaks. Our respiratory therapy business is showing a decline. Although on closer examination, our sales into dealers in North America is lagging behind dealer sales to hospitals. We expect this lag to correct itself by the first quarter of 2016. That correction, along with anticipated benefit from some GPO wins, lead us to believe that respiratory therapy revenue growth will be in positive territory in 2016. Latin American businesses also experienced year-over-year revenue declines. This is primarily due to oil-producing countries like Venezuela we simply didn't have the funds available to order products. To a lesser extent, European revenue growth, whilst still positive, was diminished as a result of lower sales to Russia and the Middle East. I would add that while it's possible we could see some near-term improvement in these oil-producing countries, we are not counting on any rebound in order to hit our fourth quarter expectations. Turning to adjusted earnings per share, it was $1.60 in the third quarter of 2015, up approximately 2%. And while at first glance, 2% earnings growth may not seem impressive, in this case, that couldn't be further from the truth, as we had to handle significant year-over-year foreign currency headwinds. And these once again met underlying gross and operating margin expansion and earnings growth. Thanks to leverage generated from our higher margin products in regions, targeting operation expense cost containment initiatives and reduced interest expense and an improvement in our tax rate, the company was able to overcome a 17% foreign currency headwind and deliver adjusted earnings per share that was higher than our most recent internal projections. And before turning the call over to Liam, I would like to provide you with a brief update on the status of our manufacturing footprint consolidation plan and financial guidance for 2015. We continue to remain on track with our updated timetable for our manufacturing restructuring program and expect that we will begin to see the initial benefits in our gross and operating margins beginning in the fourth quarter of this year. While from a timing and synergy generation perspective, there are no changes from the comments we made in our second quarter earnings conference call as we continue to believe that we will be substantially complete by the end of 2017, generating annual synergies of between $28 million and $35 million on a pre-tax basis. This takes me to our 2015 financial expectations. As we've been saying all year, 2015 is a fourth quarter story for Teleflex and we expect a strong close to 2015, with revenue growth accelerating from a 4.7% level that we have achieved during the first nine months of the year. This acceleration in fourth quarter constant currency growth is based on a few key factors, including continued strength within North American markets, incremental revenue generated from already completed M&A and distributor conversions, easier comparables for our business in China and one additional shipping day as compared to the prior year's fourth quarter. Regarding our gross margin goals, we were negatively affected in the third quarter primarily by some additional expenses related to recalls. While this will modestly affect our overall gross margins for the year, we do not expect it to interfere with our 54% target for the fourth quarter. And finally, as it relates to our adjusted EPS, we are seeing strong sequential improvement each quarter this year and expect the same change to continue into the fourth quarter. This morning, we narrowed our adjusted earnings per share range between $6.20 and $6.30 per share and anticipate ending the year of close to the midpoint of that range. This new midpoint is an improvement from the midpoint of our previously provided adjusted earnings per share range. Perhaps more importantly, I'm happy to report that we are not cutting back any of our investments in Percuvance, LMA Protector, MAD Nasal or Vidacare. In fact, we continued to be quite bullish about the opportunities these products present for us. Just yesterday, we had a very exciting percutaneous presentation and demonstration from one of our leading U.S. clinical sites, and we see a lot of enthusiasm going around this product line. In summary, given our year-to-date performance, status of our end markets, the successful integration of acquired businesses and a more robust product pipeline, we feel very good where we are as a company and anticipate a strong close to 2015. I will now turn the call over to Liam and he will you provide you with an update on our strategic business unit results. Liam?
Liam Kelly - Chief Operating Officer & Executive Vice President:
Thank you, Benson. And good morning everyone. For the consolidated company, third quarter 2015 constant currency revenues grew 4.2%. The major driver of revenue growth this quarter came from improved volumes associated with our Vascular and Surgical North America, and APAC businesses combined with acquired revenue and distributors that we converted to a direct sales model. A particular note was our growth in North America, which was 5.7%, this was up from 4.3% in quarter two and solidifies our view on our quarter four and full-year growth projections. During the most recent quarter, revenue growth coming from acquisitions and go-directs contributed approximately 160 basis points towards our overall revenue growth. This was the highest contribution year-to-date and is a reflection that capital that has been deployed in terms of acquisitions is yielding returns. In addition, we also had approximately 112 basis points of growth stemming from new product introductions. This was a sequential improvement from quarter two levels, and was driven by increased revenues of our European ASK CVC kits, surgical product introductions stemming from our partnership with a robotics provider, new OEM product sales to other large medical device companies, and increased revenues of our Rusch disposable LED laryngoscope. Additional sales coming from new product introductions in the quarter were somewhat offset by a decline in new product sales within our Vascular business. This was due to the lingering effect of the ArrowADVANTAGE PICC recall that occurred late in the second quarter of the year. I'm pleased to say that we expect to have this issue rectified and behind us by the middle of the fourth quarter. Moving next to product volumes. The increase this quarter on our overall revenue growth rate from product volumes increased from approximately – increased with approximately 115 basis points. This came from two key areas. Vidacare constant currency revenue growth rebounded from quarter two levels, generating approximately 66 basis points of overall company revenue growth, while poor core product volumes increased by 49 basis points. Vidacare revenue growth was particularly strong in the Vidacare OnControl bone marrow and biopsy product lines. The market for these products is still somewhat in their infancy, but we are very encouraged by the growth rate they exhibit in the quarter. As it is our belief that these products offer a superior patient clinical outcome and have the opportunity to address a market that currently uses a very manual and often painful approach to bone marrow and biopsy procedures. Year-to-date, Vidacare continues to track in the high teens range as a revenue growth percentage. We still believe this will continue and improve through the fourth quarter. Core product volumes was led by a very strong North American central venous catheter volumes and Asia volumes, which were up approximately 2%. These increases, however, were somewhat offset by year-over-year volume declines due to macroeconomic issues in Latin America, particularly in Venezuela, and European volumes which were relatively flat as compared to the third quarter of 2014. Our volumes was also impacted by the previously mentioned recalls, which occurred late in quarter two and were not completed – completely resolved in quarter three. Finally from a core product pricing standpoint, we saw the average selling price of our products expand. As such, this led to additional revenue growth of approximately 37 basis points, and was a sequential improvement from the second quarter in which product pricing was relatively flat. The ability for Teleflex to continue to drive positive product pricing is promising. As in the quarter, product pricing was particularly strong within our North American surgical and cardiac businesses. Next, I would like to provide some additional color surrounding our segment and product-related constant currency revenue growth drivers. Vascular North America third quarter revenue increased 8.6% to $82.6 million. The increase in Vascular revenues was largely due to sales of central venous and arterial catheters, Vidacare EZ-IO and OnControl devices and catheter navigation products. Moving to Anesthesia North America, third quarter revenue was $47.6 million, up 1.6% versus the prior year period. Growth in this segment during the quarter was driven by increased sales of LMA MAD Nasal Atomization products, as well as higher sales of laryngoscope Airway Management devices. Turning to our Surgical North America business, its revenue increased 11.1% to $39.6 million. The increase here was due to higher sales of automatic polymer ligation appliers, access ports, chest drainage products and the positive contribution from the MiniLap acquisition, which occurred in December of 2014. Shifting to our overseas businesses, EMEA revenues totaled $120.9 million in the quarter and generated a constant currency revenue growth of 1.1%. This was down slightly compared to the performance this segment realized in the first half of the year. Our strength in Vascular, Anesthesia, and Urology sales were somewhat offset by declines in surgical product sales. Surgical sales were lower year-over-year due to the discontinuation of some low-margin products, which occurred in late 2014, which impacted the overall growth in EMEA by roughly 1%. As such, this led to a difficult comparable for European surgical products. While the discontinuation of these products has a negative impact on our year-over-year revenue comparable, it has a positive relative growth margin percentage impact as the discontinued products have lower margins than our core business. Moving to Asia. Our third quarter revenue increased 11.3% to $61.9 million. The quarterly increase in Asia revenue was primarily due to higher central venous catheter sales within China and improvement in respiratory sales within Australia and the impact from the acquisition of Human Medics and Stenning, as well as our go-direct initiative in Japan. Turning to OEM. Revenue in the third quarter increased 2.5% to $39 million and was primarily due to higher sales of introducer, dilator and catheter products. Similar to our European surgical products, our OEM business has a tough comparable as in the third quarter of 2014, it benefited from a spike in suture product demand due to the ordering patterns from some of its large customers. As we transition to the fourth quarter, our OEM division does not face the same difficult comparison and as such, we expect OEM revenues to improve from the constant currency levels achieved in quarter three. And lastly, our all other segments revenue for the quarter was down 2.7%, totaling $52.1 million. The decline in other revenue was due to lower sales within Latin America and respiratory products that was referred to earlier. Latin America was impacted by the devaluation of local currencies within Brazil and Venezuela, which resulted in lower amount of U.S. dollar denominated sales. We do not see this having a long-term impact to Teleflex as these geographies only represent approximately 1% of our global sales. Next, I would like to shift gears and update you on additional group purchasing organization and IDN agreements that we received. During the third quarter, Teleflex is awarded a total of 12 agreements. This represents the largest amount of agreements awarded in any single quarter dating back to the fourth quarter of 2014. Of these agreements, two are brand new, while 10 were renewals of existing awards. The two new GPO wins were both sole source awards and were in the surgical instruments and chest drainage product areas. The remainder include items such as CVCs, antimicrobial PICCs, laryngoscopes, hemodialysis catheters, surgical ligation, and laryngeal mask product categories. We continue to be quite pleased with the progress we are making in these areas and believe that these GPO and IDN wins continue to position us for growth in 2016 and beyond. Next, I would like to update you on a recent product regulatory approval that we received, as well as an award we were bestowed within the industry. The ARROW brand name is synonymous with leadership in the CVC space. And recently, we've been expanding our expertise into catheters to include peripherally inserted and hemodialysis product offerings as well. To this end, we have been investing behind our dialysis product lines and during the third quarter, we received 510(k) Market Clearance from the FDA for our ARROW Triple Lumen Pressure Injectable Acute Hemodialysis Catheter. While our dialysis access product sales make up a small amount of our total company revenue to-date, the revenue growth rate from these products is approximately 6% on a year-to-date basis. And it is our belief that the hemodialysis space will continue to be a growth driver for the company in the future. This particular device, which is available in our ARROW ErgoPack System, will help hospitals maintain compliance with current vascular access guidelines and standards while improving maximal barrier protection against infections and should contribute to future dialysis sales growth. Another area of investment for the company has been in the area of minimally invasive laparoscopic access. This includes the recent acquisition of MiniLap and the limited market release of our Percuvance product line. It also includes our Weck brands for surgical products including the Weck EFx Shield Fascial Closure System, which was recently selected as a 2015 Innovation of the Year by the Society of Laparoendoscopic Surgeons. This new device is designed to allow surgeons to provide fast and safe closure of laparoscopic port sites and is the only shielded port closure device that provides enhanced shaft protection for consistent and uniform closure, an innovative technique with unassisted suture retrieval and an intuitive wing development. We are honored that this product has been awarded the distinction of the 2015 Innovation of the Year, and we are enthusiastic about the future growth potential of this product. Finally, before turning the call over to Tom, I would like to review an acquisition that we recently completed and we believe will benefit our Surgical division. As many of you already know, Teleflex has a strong presence in the area of ligation clips with our Hem-o-lok product line. During the third quarter, we continued to bolster our position within the ligation space with the acquisition of certain assets of Atsina Surgical. Atsina, a portfolio company of Option3 and Research Corporation Technologies, is a developer of surgical clips. This acquisition complements our existing surgical ligation portfolio as the Atsina gauger clip has proprietarial angular element or elbow that secures and then pulls the tissue proximally during closure. This all cash acquisition is yet another example of Teleflex executing upon its strategy of acquiring innovation, pre-revenue – sorry, acquiring innovative pre-revenue technology, that allow us to take years off the product development cycle and eventually leverage our sales platform to support new product growth and capture additional margin. That completes my prepared remarks. And with that, I'll now turn the call over to Tom. Tom?
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Thanks, Liam, and good morning, everyone. Given the previous discussion of the company's revenue growth drivers, I will begin my prepared remarks with the gross profit line. Before I do, I'll reinforce the point made earlier, which is that, underlying operating performance remains on solid footing. Additionally, we remain on track to achieve our full-year 2015 constant currency revenue and adjusted earnings per share objectives. Consistent with second quarter results, foreign currency impacts have again hampered revenue, margin, and earnings growth. For the third quarter, we estimate that the impact of foreign currency was to reduce adjusted earnings per share by approximately $0.27. If we were to exclude the currency impact, earnings per share growth would have been approximately 19%. And given the magnitude of the currency impact, I'll break out currency as I reviewed third quarter results so that you can gain a better understanding of Teleflex's underlying operational performance. Turning now to results. For the third quarter, constant currency revenue growth was 4.2% and reported revenue decreased 2.9%, reflecting an adverse currency impact of approximately $32.8 million. For the third quarter, adjusted gross profit was $230.5 million versus $238.1 million in the prior year quarter. Adjusted gross margin was 52%, which was down 10 basis points and compared to the prior-year period. During the third quarter, we realized the benefit of favorable product mix, principally in the Surgical North America, Vascular North America, and Asia segments, as well as the impact of improved pricing largely within the Asia segment. Additionally, we realized improvement in adjusted gross margin for manufacturing cost improvement programs, distributor conversion, and the acquisitions of Truphatek and MiniLap. However, these improvements in adjusted gross margin were offset by both the unfavorable impact of product recall-related expenses that served to reduce gross margin by approximately 50 basis points, and by higher costs incurred while in the manufacturing transfer/start-up phase. Additionally, foreign exchange rates reduced gross margin by approximately 50 basis points, during the quarter. We continue to have success controlling discretionary and overhead spending. For the quarter, adjusted SG&A expense was down slightly from year-ago spending levels. As percentage of revenue, third quarter adjusted SG&A was 27.9%, and marking a 100-basis point sequential decline from that of the first quarters and second quarters of 2015. Third quarter adjusted operating profit and margin were $94.1 million and 21.2% respectively versus $99.1 million and 21.7%, respectively, in the prior-year quarter. The decline in adjusted operating margin was due to the combination of the unfavorable impact of foreign exchange and recall-related expenses. In addition, in the third quarter of 2014, we had an atypically high operating margin, marking for a tough comparable. On a sequential basis, operating margin increased by 80 basis points in the second quarter of 2015. Again, if you were to normalize our results to exclude the impact of currency, adjusted operating margin in the quarter would've been approximately 22.7%. Adjusted net interest expense was approximately $11 million in the quarter and down sequentially, following the second quarter refinancing of six and seven and eight senior subordinated notes, as well as the repayment of approximately $50 million in revolver borrowings during the third quarter. As a result of these transactions, we anticipate that adjusted net interest expense will remain in the $11 million range for the fourth quarter. Moving next to our adjusted tax rate. For the third quarter of 2015, the adjusted tax rate was 13.3%, a reduction of 550 basis points as compared to the prior year period. The year-over-year reduction is primarily due to a tax benefit associated with U.S. Federal tax return filings and a benefit associated with a reduction in the estimated tax with respect to non-permanently reinvested income due to an increase in the estimated tax credits available to reduce the U.S. tax on any future repatriation. On the bottom line, third quarter adjusted earnings per share was $1.60 or an increase of approximately 2%. If we were to eliminate the impact of foreign currency, earnings per share growth would have been approximately 19%. Turning now to select balance sheet and cash flow highlights. While the year-to-date cash provided by operations was approximately $177 million, which is running behind year-ago levels, largely the result of increased accounts receivables as well as a decrease in accounts payable, and accrued expenses. The increase in accounts receivable are primarily due to increased collections of receivables during the first nine months of 2014 primarily in Europe. Accounts payable and accrued expenses decreased primarily due to the timing of both interest payments and select vendor payments, and we look to make these timing issues up in the fourth quarter. In addition, we experienced an increase in employee-related benefits and compensation payments earlier in the year. As we look to the fourth quarter, we expect an improvement in cash flow and project that full-year cash flow from operations will be approximately $275 million. From a balance sheet standpoint, at the end of the quarter, cash on hand totaled approximately $276 million of which approximately $39 million was based in the United States. Turning next to an update of our full-year 2015 financial guidance. As discussed, we remain on track to achieve our full-year 2015 constant currency revenue and adjusted earnings per share objective and look to finish the year with a strong fourth quarter. As such, we are narrowing our constant currency revenue growth range to 4.7% to 5.5% for the full year. We expect a strong fourth quarter will push our full-year constant currency growth rate above the 4.7% growth achieved through the first nine months of the year. The acceleration in fourth quarter constant currency growth is due to one additional shipping day, which is estimated to deliver an additional 90 basis points of growth in the fourth quarter. And we also have an easier comparable on China during the fourth quarter. Further, we expect to generate incremental revenue from already completed M&A and distributor conversions. And finally, our North American markets have performed well through the first nine months and we expect for this robust growth to continue into the fourth quarter. On an as reported basis, our outlook is for full-year revenue to be in the range of minus 1.5% to minus 2.3% versus a year-ago level. And we're currently projecting closer to the midpoints of both the full-year constant currency and as reported revenue ranges. Continuing down the income statement. On our last earnings conference call, we've guided 2015 adjusted gross margin to be in a range of between 53% and 54% for the year, stating that we expect it to be closer to the lower end of that range. We now project 2015 adjusted gross margin to be between 52.5% and 53%. The revision is primarily attributable to expenses incurred in connection with the previously discussed quarter three calls. The current projection represents an approximate 100 to 150-basis point improvement in adjusted gross margin versus 2014, and it includes an unfavorable currency impact that we estimate will reduce full-year gross margin by approximately 50 basis points. Consistent with our previous comments, we expect fourth quarter adjusted gross margin to improve sequentially from the third quarter to approximately 54%. The projected sequential improvement in adjusted gross margin is based on the assumption that we will not incur a similar level of recall-related expenses in the fourth quarter. In addition, we project improved manufacturing overhead absorption from increased fourth quarter volumes and a positive margin impact of distributor go-direct and continuing efficiency gains from manufacturing cost improvement programs. Moving on to adjusted operating margin. For full-year 2015, we now expect adjusted operating margin to increase by approximately 150 to 200 basis points to a range of 21.5% to 22%. This range is lower by 50 basis points from previous expectations to reflect the reduction in our full-year adjusted gross margin range. Similar to gross margin, we expect both our sequential improvement in a year-over-year improvement in the fourth quarter adjusted operating margin. This improvement reflects both strengthening fourth quarter gross margin and improved fourth quarter SG&A leverage. Similar to gross margin, we expect the foreign exchange headwind to adversely impact adjusted operating margin. Currently, we estimate that adjusted operating margin would have been approximately 100 basis points higher, if not for foreign exchange. And turning to taxes, given our third quarter results and expectations for the balance of the year, we are improving our full-year adjusted tax rate assumption to a range of 18% to 18.5%. This is a reduction from our previous full-year estimated rate of between 20% and 21%. Of note, our current rate estimate does not assume a benefit from a potential 2015 R&D tax credit. Turning to EPS. We are narrowing our adjusted earnings per share range to between to $6.20 to $6.30 per share versus a prior range of $6.10 to $6.35 per share. This new range translates to EPS growth between 8% and 9.8%. In closing, with nine months of 2015 behind us, we are pleased with our results today. Our largest market, North America, continues to perform well, allowing us to deliver year-to-date constant currency growth of close to 5%. We expect to finish the year strong, which should set us up for a good start into mid-year. Throughout the year, we've successfully integrated distributor conversions and smaller acquisitions that will enhance revenue growth and margin expansion as we close out the year. In addition, the previously announced manufacturing restructuring program remains on track and we're taking steps to further reduce our operating expense cost base to drive additional financial leverage. And finally, we've been able to absorb significant foreign currency headwinds and remain on track to achieve our adjusted earnings per share target. That concludes my prepared remarks. At this time, I'd like to turn the call back over to you, operator, for questions. Operator?
Operator:
Your first question comes from the line of Larry Keusch from Raymond James. Please proceed.
Lawrence S. Keusch - Raymond James & Associates, Inc.:
Good morning, everyone. I was wondering if we could just start with the recall expenses and just trying to understand why that deviated from your initial expectations where you thought that there would be very minimal impact in the quarter.
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, that's a good question. As you recall, Larry, the recalls happened at the very end of the second quarter. What we reported on in our earnings call last time was our best estimate at that time. As it turns out, the root causes for some of the recalls turned out to be harder for us to get, in the cases of our PICC product line, in particular, there was more than one problem associated with the remedy. So, you're absolutely correct that these turned out to be greater than what we thought they were going to be at the time when – during our last call. It's one of those things that you have to keep at it until you actually find the root causes of a problem and fix it. So, it took us longer. We've identified what that problem is now and I think we are in much better shape at predicting the – the fact that there's not going to be an impact in the fourth quarter.
Lawrence S. Keusch - Raymond James & Associates, Inc.:
Okay. That's definitely helpful. And then secondly, you obviously have done a nice job of steering us to what the 4Q will look like, but at this juncture as we're kind of finishing up the month of October here, I'm wondering if you could at least give us some high-level thoughts as to how you guys are thinking about 2016 maybe from a – again from a top line growth perspective and kind of how you're thinking about margins playing out?
Benson F. Smith - Chairman, President & Chief Executive Officer:
Yeah. So again, we are – I think have a good level of confidence that we're going to see a fourth quarter in the range of 54%. I think that will give people a lot of confidence in the – the margin improvement story is well intact. That's going to then service the jumping off point for us really as we move into 2016. And other than the comments we made on the last earnings call, where we have moved one of the wet kit manufacturing essentially ahead of about three months, I would say that everything else is right on track where we expect it to be originally and still on track from what we predicted and estimated it to be on the last call. So – and as through nearly a third of the fourth quarter, we haven't seen any surprises come up. So, we see a pretty high level of confidence I think in a robust fourth quarter.
Liam Kelly - Chief Operating Officer & Executive Vice President:
And Larry, I'll just touch on the revenue line. We don't deviate at all from what we said at our Analyst Day, we expect 5% to 6% constant currency growth. We have some exciting products in the pipeline. The Protector that Benson mentioned earlier, and Percuvance, which we think will augment our revenue to 2016 and beyond.
Lawrence S. Keusch - Raymond James & Associates, Inc.:
Okay, great. Thanks very much, guys.
Operator:
Your next question comes from Kristen Stewart from Deutsche Bank. Please proceed.
Kristen M. Stewart - Deutsche Bank Securities, Inc.:
Hi, guys. Thanks for taking my question. Benson, I was wondering if you could just comment on just kind of the broad markets again. If I look at the businesses, a lot of the different segments did seem to improve across some – kind of in the second quarter to the third quarter with, I guess, the exceptions being the other area, which a lot of other companies have seen weakness within Latin America and then, I guess, a little softer results in EMEA. But North America clearly looked to have picked up. And then, overall, I guess, your tone seems to be pretty positive heading into the fourth quarter and it seems to be setting up for a pre-very strong, I guess, 2016. Some other companies have talked a lot about FX, seems like FX was hitting you guys pretty hard this year with pretty heavy impact on EPS. Just wanted to make sure, as you stand here today, what's the outlook for FX kind of looking into 2016?
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, FX in the third quarter had a bigger impact on us than what we expected. As we move into the fourth quarter, we're now going to see comparables to the prior year, which are a lot less severe than they were for the first three quarters. So that's in the short term – in the short term, that's kind of where we see FX. I would love to be able to tell you that we have the currency situation figured out for 2016. I think – but there's a lot of volatility there. Our general assumption is that we're going to likely see continued strengthening of the U.S. dollar. We don't think it's going to be at the same level of comparison that we saw in 2015. One of the reasons, quite frankly, that we're putting more and more resources around growth in the U.S., and there really is two reasons
Kristen M. Stewart - Deutsche Bank Securities, Inc.:
Right.
Benson F. Smith - Chairman, President & Chief Executive Officer:
But we're not expecting the same level of severity that we saw in 2015, and I'll turn it over to Tom now to give you a little bit more detail.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Yeah, sure. So to Benson's point, in 2015, we saw a pretty big move in the U.S. dollar relative to the euro, and that's the currency that we're most impacted by or that relationship. We do about 30% of our business in euros. And so as we look at the average rate for 2014, it was about $1.33 this year based on where we're currently trading, it's probably going to be around $1.11. So to think that there's going to another $0.22 move to 2016, we're hoping that's not the case, but we are looking for a likely continued strengthening of the U.S. dollar to some degree. But again, as we look at this year, we were able to put together a number of actions to offset that currency impact and still put forth pretty strong earnings growth despite what was a very significant impact to earnings as a result of currencies.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Now, I'll have Liam to comment a little bit on the end markets that you asked about.
Liam Kelly - Chief Operating Officer & Executive Vice President:
Yes, so, as we see North American growth, you're right, Kristen, we see it as accelerating in the, we've seen a pickup in quarter three, it was 4.34% in quarter two to 5.7% in quarter three. And obviously, that has an impact on currency growth because all of those sales are denominated in U.S. dollars. Then the overseas market, yes, we have seen a little bit of softness in particular in the oil-based countries, in particular in Venezuela, Brazil and Russia, and a little bit in the Middle East in that order. So, that's what we're seeing out there.
Benson F. Smith - Chairman, President & Chief Executive Officer:
And that amounts to about 1% of our overall revenue, and once that's out of the mix, we should have more favorable comparisons moving into the latter half of next year. And I would say we have taken that into account in our fourth quarter estimates. We've already taken that into account with our revised guidance.
Kristen M. Stewart - Deutsche Bank Securities, Inc.:
Okay, perfect. I'll get back into the queue. Thanks.
Operator:
Your next question comes from the line Matt Taylor from Barclays. Please proceed.
Matt C. Taylor - Barclays Capital, Inc.:
Hi. Thanks for taking the question. Can you hear me okay?
Benson F. Smith - Chairman, President & Chief Executive Officer:
Yeah.
Liam Kelly - Chief Operating Officer & Executive Vice President:
Yeah.
Matt C. Taylor - Barclays Capital, Inc.:
Great. So, I was hoping you could delve into some of the OUS commentary a little bit more – a couple of things. On the prepared remarks, you mentioned that China was a little bit weaker, so I was wondering if you could talk about that? And then in terms of some of these oil-based countries, could you help characterize the weakness? Was this lack of distributor buying or utilization weakness? What kind of visibility do you have into those countries over the next two or three quarters?
Liam Kelly - Chief Operating Officer & Executive Vice President:
So, I'll take the oil-based country question. So – and I'll just speak specifically about Latin America first. So what we saw within the quarter, and we sell mass in U.S. dollars to these distributors within Latin America. So with the devaluation of their currency, that has obviously had an impact in their ability to purchase at a consistent rate or improved rate from last year. So, really the impact on Latin America was in the region of about 57 basis points on our overall revenue growth. And on Latin America itself, it was – it's greater than a 10% impact, largely driven by Venezuela, and it is the devaluation of the currency, but also our distributor is awaiting on payment from the government there. And we see it becoming coming back once the government pays our distributor because he has orders within the pipeline already, but he's not willing to shift towards those from others, shift them through his channel until such time as he receives payment from the government. So, we should see Venezuela, in particular, show some rebound as we move forward into 2016. With regard to your question on Asia and China, we saw a slight decline actually in China within the quarter, but we saw very strong performance in APAC overall of 11.3%. India, which has rose up there, was increased by 16%. Australia and Japan and Southeast Asia and Korea were also in the double-digit range. So, the softness in China where there was strong in central venous catheters, we saw some pressure on our less differentiated products, in particular within our Anesthesia and Respiratory segment.
Jake Elguicze - Treasurer & Vice President-Investor Relations:
Hey, Matt, this is Jake. One other comment I would add is that China came in pretty much right in line with our expectations for Q3 and we still do expect Q4 to be pretty robust.
Liam Kelly - Chief Operating Officer & Executive Vice President:
And Matt, as we get into Q4, I think Tom mentioned already, we have an easier comparable in Q4, and we expect a very strong rebound in China on core growth and as a result of that comparable. If you recall last year, we realized that some of our distributors in Asia were building up some inventory, and we took the decision at that stage to not to ship to some of those distributors.
Matt C. Taylor - Barclays Capital, Inc.:
Thanks for that.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Guys, thank you. Longer range, Matt, our view is that undifferentiated products which have a local Chinese manufactured competitive entry are going to be hard to achieve the kind of growth rates in the past. And there's a – there's certainly a strong trend towards nationalization now from the current regime in China that is somewhat pushing adoption of its homegrown, homemade products. So, and our strategy has all along been to emphasize what we think are the most differentiated products. So, I don't think it's going to have an enormous impact on us, but China is a changing environment now, and we continue to monitor, I think a lot of activities there.
Matt C. Taylor - Barclays Capital, Inc.:
Okay. And just one on the margin there, so you were able to get some pricing in the quarter. I guess I'm curious about the outlook as to whether your views on your ability to get additional price that have changed. And then given the volatility that you're talking about, how does this change, if at all, your views on the attractiveness of buying additional OUS distributors and your ability to take your margin there?
Benson F. Smith - Chairman, President & Chief Executive Officer:
So I think our – just to clarify at least what I think we were saying about pricing was, we have not counted on pricing as a key component in our stated three-year goals, but that we were going to take price every place we could find it. So, I think we're seeing – I think we're seeing our ability to do that and are pleased with our ability to do that. But given the – given other pressures in the marketplace, we're not relying on that to hit our three-year margin expansion goals. I think it's one of those areas where we've been conservative and we'll probably do better than what we've committed to, and it's certainly the case that we keep looking for price opportunities every place. I do think there are some markets that we have shied away from thinking about distributor to direct conversions. We have about $169 million that goes through the kinds of distributors that offer us a significant margin improvement. We've identified about a third of that in geographies where we think it makes sense to do that. So, I think the changing dynamics has affected our view of which geographies are more attractive to us, but I still think we're in the range of seeing, over the next couple years, the overall impact from the dealer-direct conversions, about the same as it has been for the past two years. And Liam is much closer to this than I am, so I'll let him comment on it also.
Liam Kelly - Chief Operating Officer & Executive Vice President:
No, I would just concur what you said, Benson. You can expect - and as we said during our Analyst Day, you can expect the same level that you've seen in the coming two to three years that you've seen in the past two years. The impact within the quarter of pricing was 37 basis points. And if you look at the dealer-to-convert, the dealer-to-direct, that added another 71 basis points of pricing. So, it's a strategy that's adding value, so we anticipate to continue with that strategy.
Benson F. Smith - Chairman, President & Chief Executive Officer:
I think more to remain to our ability to grow our revenue is, it has to do with our ability to continue to improve our share position in the U.S. and I think that our expectation around the demographic impact on the overall U.S. market. And then to a lesser extent, at least in this three-year period, those key product areas, Percuvance, LMA Protector, MAD Nasal kicking into the latter half of those three-year period. So that's really the core of what we need to do to hit those revenue numbers that we've outlined.
Matt C. Taylor - Barclays Capital, Inc.:
Okay. All right. Thanks a lot for your comments.
Operator:
Your next question comes from David Lewis from Morgan Stanley. Please proceed, sir.
Jonathan Demchick - Morgan Stanley & Co. LLC:
Good morning. Hello, this is actually John Demchak in for David. Thanks for taking the questions.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Good morning.
Jonathan Demchick - Morgan Stanley & Co. LLC:
Good morning. So, I think we talked a little bit about the dealer direct distribution conversion side, but other on the M&A side. It's now been a year-and-a-half, two years since the last, I guess, larger deal that you guys have done. You've made a big deal in Vascular, a big deal in Anesthesia. You haven't really done, I guess, a larger deal in Surgical. Could you maybe talk about the environment that you're seeing in the broader deal environment and if Surgical is poised for the next larger deal that you guys are looking for?
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, certainly from a standpoint of smaller deals, we've been more active than we've ever been in terms of late-stage or ready-to-go product acquisitions. I will just tell you that we – our mindset is to be extremely selective about the larger deals that we're going to do. We almost always, if not always, have some level of conversations going on. This process can take time. We often have sellers that have walked the expectations, and it takes a little bit of reality sometimes for them to understand that they're not going to get what they expect to get. There continues to be things for us to look at. I would say overall, our M&A department is as busy now as it's ever been, and we still would characterize ourselves as a serial acquirer and are quite active in the looking and conversation phase of that.
Jonathan Demchick - Morgan Stanley & Co. LLC:
Okay. And just wanted to follow up on margins a little bit. I know we've kind of gone into it a little bit so far, FX and the recall have been pretty well explained. But as we look into the fourth quarter, it looks like guidance is assuming two to three points of, I guess, sequential improvement into the fourth on the operating side. And maybe a point of that's from FX pressures waning and recall expenses going away, but can you kind of talk about what's driving the remainder of the improvement into the fourth? And then also, is the fourth quarter the right starting point to think about as we kind of head into 2016?
Benson F. Smith - Chairman, President & Chief Executive Officer:
Sure. Well, let's just talk about gross margin. So, in the third quarter, we were at 52% on an adjusted basis and as you think about the guidance out there, it does to your point, show an improvement. And what we're counting on is, first of all, the recall-related expenses that were incurred this quarter we do not assume are going to reoccur. We also have got a fairly significant increase in revenue during the fourth quarter in part to just what is typically the fourth quarter, then we also have the extra shipping day. And that will drive improved absorption on a higher – on the higher volumes. We also have some improved mix. As our businesses from the acquisitions and distributor conversions to start to build momentum, we'll continue to drive higher, I guess, levels of revenue at a higher – at a higher margin, and that will help our mix. And then we had a couple of what I would characterize as one-off cost during the quarter, none of them were – were significant individually, but collectively they added up to have an impact. And a lot of those were costs associated with the transition of moving manufacturing or getting new operations up and started. So we expect to see those – those types of costs abated in the fourth quarter. And then we also will start to see the benefit of our manufacturing footprint consolidation program as trying to deliver some savings in the fourth quarter. So collectively, you put all those together and those are going to be the drivers that help us get from where we are to – to a higher level next quarter.
Liam Kelly - Chief Operating Officer & Executive Vice President:
And I would add that we would have to see something really that is not visible to us now occur between now and the end of the year, I think, for us to be right in that 54% range. And the second point is, yes, we think that's a good jumping off point for 2016.
Jonathan Demchick - Morgan Stanley & Co. LLC:
On the SG&A side, there also seems to, I guess, be somewhat of an uptick there as well. Is there anything organically that we should be thinking about to get us little more comfortable or is that more just the added absorption, when you talk about the larger sales?
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
We've seen uptick and improvement in the...
Jonathan Demchick - Morgan Stanley & Co. LLC:
Sorry, improvement, correct.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Okay. Yeah, so, we made it a real focus in 2015 to take a look at our SG&A spending to make sure that we were as efficient as possible, so that we will get more of the gross margin gains falling through the operating margin. It's just a continuation of those efforts – the better leverage, better Youshare (53:53) services, focused on travel expenses and all the things you do to drive cost out. So, we've seen improvements going on throughout the year. We had a good third quarter. We expect it to continue to improve into the fourth quarter as a result of the focus.
Jonathan Demchick - Morgan Stanley & Co. LLC:
Thank you very much.
Operator:
Your next question comes from Matt Mishan from KeyBanc. Please proceed.
Matt Mishan - KeyBanc Capital Markets, Inc.:
Hey. Good morning, everyone.
Liam Kelly - Chief Operating Officer & Executive Vice President:
Good morning, Matt.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Good morning.
Matt Mishan - KeyBanc Capital Markets, Inc.:
Hey, I know you guys have already covered this, but just to clarify, what is your exposure to the oil-producing countries, Venezuela, Brazil, Russia, Middle East as a percentage of sales? And then, what was the percent headwind into sales in the quarter?
Liam Kelly - Chief Operating Officer & Executive Vice President:
So, as a percent of sales, our exposure is just slightly over 1% of our total revenue goes through the countries that you mentioned. Sorry, just over 2%. 2% to 3% of our revenue goes through the countries that you mentioned. So, it's not a significant driver of our overall global revenue.
Matt Mishan - KeyBanc Capital Markets, Inc.:
And what was the headwind in the quarter on a percentage basis, like on to sales from those countries?
Liam Kelly - Chief Operating Officer & Executive Vice President:
From those countries, it was approximately for – for Latin America, it was 57 basis points, and for Russia and Middle East, it was probably about another 5 basis points.
Matt Mishan - KeyBanc Capital Markets, Inc.:
Okay. And then on Vidacare, I think you said last quarter that you thought this would – that it would be in the plus 20% range in the back half of this year. Where did that come in?
Liam Kelly - Chief Operating Officer & Executive Vice President:
So, the Vidacare is tracking at the moment in the region – in the high teens at the moment on a year-on-year basis, driven by good performance on EZ-IO and stellar performance in OnControl. So in the quarter itself, it came in at 14% and is tracking year-to-date in the high teens.
Matt Mishan - KeyBanc Capital Markets, Inc.:
Is that coming in a little bit....
Benson F. Smith - Chairman, President & Chief Executive Officer:
And we expect to finish it in the high teens.
Liam Kelly - Chief Operating Officer & Executive Vice President:
Yeah, we expect a very strong finishing quarter four, as we do in most quarter four for this type of a product where municipalities tend to replenish their stocks at the end of the quarter.
Matt Mishan - KeyBanc Capital Markets, Inc.:
Okay. Perfect. And the last question, I think last call you talked about expanded use by surgeons of Percuvance in different kind of surgeries. Have you also updated your thoughts on potential market size? I think you initially thought it was maybe $300 million to $400 million, is it maybe a little bit more than that now?
Benson F. Smith - Chairman, President & Chief Executive Officer:
Well, the overall market for this type of surgery in its totality is significant as you're aware, Matt. And we've taken a percentage of the overall laparoscopic markets that gets us to that 300, 400. I can tell you that with Percuvance, we have now completed 198 cases, we're active and seven sites in the U.S., eight outside of the U.S. We have 300 surgeons signed up for a training program that is taking place in November. We had an internal training that Benson mentioned in his prepared remarks that took place yesterday from a key teaching hospital, that was very exciting. At this stage, we're not going to update how big we think the market is. We still think it's a $300 million to $400 million opportunity. As we get into the actual product launch, Matt, we may update then, but the overall size of this market is in the billions, as you know.
Liam Kelly - Chief Operating Officer & Executive Vice President:
One of the really interesting things that came out of this presentation yesterday was that – one of the ideas behind single site incisions and Percuvance was the reduced scarring to patients. And some of the physicians we are commenting with replacing a lot of emphasis on the flexibility of using the instrumentation versus just the cosmetic effect, and that seemed perfectly reasonable to us. Now, as they're treating more and more patients, the patients themselves are responding really, really favorable to the cosmetic results, and we're starting to see a change in thinking about the value that that brings to the procedure. So, everything we've learned since the last – since the last conversation we've had with you about this read us to be more bullish about the acceptance of the product.
Matt Mishan - KeyBanc Capital Markets, Inc.:
Okay. Thank you very much.
Operator:
Your next question comes from Jason Wittes from Brean Capital. Please proceed.
Jason H. Wittes - Brean Capital LLC:
Hi, thanks. Just a quick follow-up on Percuvance. Are you guys saying that you think the aesthetics of Percuvance are going to be a big driver or how should we be thinking about adoption and what will drive adoption?
Liam Kelly - Chief Operating Officer & Executive Vice President:
Well, there are a number of key drivers, aesthetics for sure is one. The procedures that it's been used in are in general surgery, gynecological and neurology, and in particular in gynecological surgery, that is a key element. One of our key opinion leaders has spoken to some of these patients, and that is a key driver. The other key driver is that you don't use as many ports when you use the Percuvance. So, on one of the cases I was in, instead of using five to six ports, the surgeon used two, and that has a reduced cost. And the other key driver, and this came out really clearly in the presentation yesterday, the issue with no sills (01:00:16) a lot of these advances that they were seeing meant that the surgeon had to change the way he did the procedure. One of the key attributes of the Percuvance is there is no change in the way they do the procedure. They don't need articulating instruments. They do have to exchange extra (01:00:37). They can use the same size of heads, which is very important so that they can do the procedure in the same way as they would have done it in the past using those multiple ports. So, there are a number of drivers that makes this quite attractive to the surgeons.
Jason H. Wittes - Brean Capital LLC:
Okay. That's helpful. I appreciate that. Also wanted to get a little more color on the Vascular business, it did better than we expected. Obviously, you mentioned Vidacare. I'm curious about PICCs and especially CVC since I know that you guys have been making efforts to sort of improve – or penetration and growth there. And related to that, in respiratory that was a little bit behind. I know that you have also been extending efforts there, maybe it's a little too early to see that in the numbers, so just a little more color would be helpful?
Liam Kelly - Chief Operating Officer & Executive Vice President:
Okay. So for our CVC business globally, it grew by 6.6% on a global basis. On our PICC business – now our PICC business showed a slight decline, but that, as I said during my prepared remarks, was really due to the ongoing issue with the recall. If we added back the impact of the recall, the PICC business would have grown by just into the double-digit country. So, it was impacted by the recall. With your question on respiratory, we have built into our quarter four, thinking that respiratory will continue to show a slight decline in the – for the remainder of the year and for the balance of the year in a full-year basis we are forecasting a slight decline, but we've already anticipated that in our full-year projections.
Jason H. Wittes - Brean Capital LLC:
Should we be thinking about recovery to positive growth territory in the next – in 2016? I mean, I'm not asking for guidance, just sort of a general direction for that.
Liam Kelly - Chief Operating Officer & Executive Vice President:
Yes, our anticipation is a slight recovery. Respiratory is never going to grow in the 6% like our CVC business. But we would – we do anticipate seeing a soft recovery in our respiratory business towards – as we get into 2016.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Fairly sufficient to move it into a positive growth territory.
Liam Kelly - Chief Operating Officer & Executive Vice President:
Yes.
Jason H. Wittes - Brean Capital LLC:
Understood. Thank you. And just maybe a quick follow-up on some other questions out there. You had a few questions about end markets. I was just curious specifically if you can reconcile your growth in North America with some of the surprising results from some of the hospitals, which actually recorded some disappointing admission results recently. I don't know if you can rectify the....
Liam Kelly - Chief Operating Officer & Executive Vice President:
That's a really good question. Our conversations with providers lead us to believe, and our own sales results confirm this, that the general admission of patients is not improving, and that's one of the reasons why a product line like respiratory therapy isn't doing better. What is happening is that the acuity level of the patients that are being admitted is higher. And so that's what's driving high numbers in surgery, it's what's driving high numbers in vascular access. And these are kind of those non-postponable, inevitable visits to the hospitals that people have to make. There was a slowdown in those in 2013 and 2014, and now we continue to see that get better on a quarter-by-quarter basis. But it's not being driven by general improvements in administration – in admissions, excuse me, you're absolutely right.
Jason H. Wittes - Brean Capital LLC:
That's very helpful. Thank you very much, Benson.
Operator:
Your next question comes from the line of Anthony Petrone from Jefferies. Please proceed.
Anthony Charles Petrone - Jefferies LLC:
Thanks. Maybe a couple questions, one on China, one on margins. On China, Benson, in the past you mentioned lengthening cycle for registration processes for getting new products approved in end markets. So, maybe just an update on that situation and that country. Do you think that presents a headwind going forward? And then on margins, I know we've touched on this in the past in prior quarters. But when you look through 2017, how do you think the margin benefits from footprint will play out? Is it more gradual or do you think you'll see a step function at some point along the way?
Benson F. Smith - Chairman, President & Chief Executive Officer:
So addressing China, I think that there is a definite trend on the part of the Chinese government to make it – that's making it somewhat more difficult for non-Chinese manufacturers to introduce products. That's exhibited in lengthening approval times, a lot of – a lot of, I would characterize it as delays around even simple things like change of location of manufactured products, which now have to go through the whole complete re-registration. And the third area is increasing the fees considerably for non-Chinese manufacturers to get products through their version of the FDA. That's going to have differing impacts on different companies depending on what their profile and goals are in China. For us, it really means – it actually reinforces what our strategy has been to introduce products into the Chinese market that we think have good legs and will stay there, will be difficult for local Chinese manufactures to duplicate and worth the additional fees and time to get into the marketplace. If we were counting on much more broader based product offerings in China, I think we'll change our viewpoint but that's been our strategy with China all along. And excuse me, your other question was?
Anthony Charles Petrone - Jefferies LLC:
Just on the cadence of margins, how that plays out through 2017? Is it a step function or do you expect a gradual benefit from footprint reduction in the margin profile?
Benson F. Smith - Chairman, President & Chief Executive Officer:
When we look at the margins of the next couple of years, there is kind of two pieces to that, one is, you refer to the footprint. And on that, specifically, we had talked of savings of $28 million to $35 million. We're going to realize a small portion of that in the fourth quarter of this year, the majority of it in 2016 and then the remainder in 2017. So that is fairly 2016 focused. And in addition to the footprint, we had talked about the ability to save additional moneys and drive margin through 2018, and those other projects include initiatives such as material substitution, supplier efficiency initiatives, investments and automation, lean manufacturing, et cetera, and those projects are more evenly weighted throughout the period from 2016 through 2018. So there are not a big step function, but rather a more ratable improvement each year.
Anthony Charles Petrone - Jefferies LLC:
That's helpful. And Benson, the last one from me is just price, generally. I guess it relates to Jason's question. You look at some of the hospital prints, but they also reported lower revenue per patient, and so reimbursement seems to be being pressured a bit here and you also have HMO consolidation. So I'm just wondering, how you see that impacting the landscape going forward?
Benson F. Smith - Chairman, President & Chief Executive Officer:
I think it's one of the reasons why we're not counting on price as a part of our margin improvement goals or revenue improvement goals. However, even in a difficult environment, and I would say, it's been a difficult environment since I arrived here in 2011. Even in a difficult environment, there are some products by the fact that there's really not a good competitive alternative. They are a small part of the hospital's budget. They don't receive a lot of attention in their purchasing office. So there are – there are select opportunities to be able to get price, and it's just in our mindset to take advantage of every one of those that we can. But given the overall environment, we don't think that it's prudent to count on that as part of our margin improvement goals.
Anthony Charles Petrone - Jefferies LLC:
Thank you.
Operator:
Your next question comes from Richard Newitter from Leerink Partners. Please proceed.
Ravi Misra - Leerink Partners LLC:
Hi. It's actually Ravi in for Rich. Can you hear me?
Liam Kelly - Chief Operating Officer & Executive Vice President:
We can.
Ravi Misra - Leerink Partners LLC:
Thanks. So, a little bit of a follow-up on the North American market growth. You're seeing a pretty good acceleration in the Vascular and Surgical businesses. Looking to see your outlook on those going forward, given commentary, do you still expect these to accelerate? And then maybe one on the tax rate, came in a little bit lower than we had been modeling. Trying to figure what the sort of the long-term strategy still remains around what you highlighted at the Analyst Day? And if maybe one on the fourth quarter tax rate, how much could the benefit be if the R&D credit was reinstated? Thank you.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Okay. So I'll take the – excuse me, I'll let Liam take the U.S. revenue market question.
Liam Kelly - Chief Operating Officer & Executive Vice President:
Okay. So, we're looking at the U.S. at the moment. You're correct, we went from 4.3% to 5.7%. As we look to the remainder of the year, our current thinking is that we will just pull back a little bit on the 5.7%, just for some comparables in the prior year, but still a pretty robust performance. And then have an accelerated jump off into 2016. We see very strong growth within our Vascular segment and especially within our CVCs. Within the Surgical segment, as we move into the following year, we have the – obviously the MiniLap acquisition is in there, but then we launched Percuvance in late quarter one, earlier quarter two on a full market release into the surgical business units. And within Anesthesia, we have a very strong focus on the launch of the Protector, which will come in quarter two also.
Benson F. Smith - Chairman, President & Chief Executive Officer:
So it is in part driven by, I think, some improvement in the acuity levels that we've commented about, but our growth can't be explained by just that. We're taking market share and a lot of it has to do with the acceptance of these newer products that we're putting out in the marketplace.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
And then with regard to the tax rate, if the R&D tax credit were to be afforded to us again this year, that would probably be a 40-basis point improvement in the full-year tax rate. And then with regard to your question on the longer term tax strategy, if you will, and we talked about it at Analyst Day, first let me just talk about the benefits we realized in the third quarter are largely benefits that are contained in 2015. So, they will not have a longer term impact on our rate. And as we think about the next couple of years, and what we spoke about at Analyst Day is that a number of the actions that we have underway serve to improve the profitability of the U.S. So as we tend to move manufacturing out and restructure our cost base, we'll be driving more profits as a result of that in the U.S. In addition, we've got market growth going on in other countries that are in higher tax jurisdictions. And so what we're seeing over the next couple of years is some upward pressure on the rate and we will always look for ways to identify opportunities to offset that, but have not put any into the plan as of yet largely because they haven't been identified, so we'll continue to look for those options, but we do see and some of the actions as well as the different market growth putting some upward pressure over the next couple of years on our tax rate.
Ravi Misra - Leerink Partners LLC:
Great. Thanks. And just one clarification. Liam, that North American growth number you gave, was that – that was an organic number for the year-to-date growth?
Liam Kelly - Chief Operating Officer & Executive Vice President:
That's an all inclusive number for North America.
Ravi Misra - Leerink Partners LLC:
Thanks.
Operator:
Your next question comes from Dave Turkaly from JMP. Please proceed.
Liam Kelly - Chief Operating Officer & Executive Vice President:
Good morning, Dave.
David L. Turkaly - JMP Securities LLC:
A lot of my questions have been answered. I did want to ask if I could talk to your accountants, but down with the 13% rate in the quarter, but did you – you explained it some benefit from tax return, and I think there is some repatriation component, but can you just tell us exactly why it was that low this quarter?
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Well, there are really two pieces to it. One was in connection with the filing of our U.S. Federal tax return, where the actual expense came in less than what we had been accruing towards as the year had progressed. And the second issue was related to an initiative to further simplify and rationalize our organizational structure, so we transferred ownership of certain subsidiaries around the Teleflex group, and a byproduct of this was that it created an increase in the foreign tax credits that would be available to offset future taxes or U.S. taxes on our non-permanently (01:14:12) reinvested earnings. Now the other benefit of that movement was our ability to repatriate cash, which we did also in the third quarter. So there's really two impacts that are driving the rate in the third quarter. And as mentioned, those rates are not something that will impact the rate in future years around a sustainable basis.
David L. Turkaly - JMP Securities LLC:
Great. Thanks a lot.
Operator:
Your next question comes from Kristen Stewart from Deutsche Bank.
Kristen M. Stewart - Deutsche Bank Securities, Inc.:
Hi. Thanks for taking my follow-up. I was hoping you could just take us back and just talk to the bigger picture M&A landscape, and just talk about what you're seeing out there in terms of smaller companies, and just they're willingness just given some of the volatility out there in landscape with healthcare, and willingness to, I guess, look towards larger companies like yourself given the consolidations that's happening to partner up (01:15:37) and just what you're seeing?
Benson F. Smith - Chairman, President & Chief Executive Officer:
So I think the opportunities over the next several years are going to continue to be robust. One of the things we're seeing in the U.S. market by way of example is, it is getting tougher for, let's call them, $100 million revenue companies to be able to get a seat at the table at IDNs and at GPOs. And so, it's becoming more difficult for them that the increased cost to get your product, for example, through China make global expansion tougher for companies of that size. Even things like the medical device tax have a lot of those $50 million revenue companies just at the brink or below profitability. So there have been an increasing number of environmental factors in the healthcare marketplace that make it more difficult for those size companies. This year, our currency is a negative factor when we try to look at European assets, because they have one view of what their sales increases is, when they're doing their calculations in their own currency, when we have to denominate that into dollars what it's going to do us. In many cases, what looks like growth to them is actually negative to us by the time we go through the currency translation. So, that's having some short-term impact in terms of how we might see evaluation and they might see evaluation. Again, once we see a more stable environment where currencies aren't a big issue, that will start to evaporate a little bit. That's the only thing I think that's on the horizon that makes the market at least in acquiring European assets a little bit more difficult than normal.
Kristen M. Stewart - Deutsche Bank Securities, Inc.:
And I guess as we look out over the next, I guess, 12 months to 24 months, would be likely for us to see you guys do another larger transaction or just likely more tuck-ins?
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, help me understand what you see by...
Kristen M. Stewart - Deutsche Bank Securities, Inc.:
I guess An LMA-type transaction.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Yes. So, in the next 12 to 24 months, I would be really surprised if you didn't see that, yes. I think we're still not in the mindset of some kind of transformational acquisition that would be in the billions of dollars. But in that, I think our range now is probably in the $300 million to $700 million where we'd consider that certainly capable financially for us to do that, and I would be very surprised if you didn't see one in that period.
Kristen M. Stewart - Deutsche Bank Securities, Inc.:
Okay. Perfect. Thank you.
Operator:
I would now like to turn it over to Jake Elguicze for closing remarks.
Jake Elguicze - Treasurer & Vice President-Investor Relations:
Thanks, operator, and thanks everyone for joining us on the call today. This concludes the Teleflex Incorporated Third Quarter 2015 Earnings Conference Call.
Operator:
Ladies and gentlemen, thank you for your participation. You may now disconnect. Have a wonderful day.
Executives:
Jake Elguicze - Treasurer & VP, IR Benson Smith - Chairman, President & CEO Liam Kelly - EVP & COO Thomas Powell - EVP & CFO
Analysts:
Larry Keusch - Raymond James Jon Demchick - Morgan Stanley Matt Mishan - KeyBanc David Turkaly - JMP Securities Ian Mahmud - Barclays Anthony Petrone - Jeffries Jason Wittes - Brean Capital Ravi Misra - Leerink Partners
Operator:
Good day, ladies and gentlemen, and welcome to the Quarter Two 2015 Teleflex Incorporated Earnings Conference Call. My name is Emma, and I will be your operator for today. At this time, all participants are in listen-only mode. We will conduct a question-and-answer session towards the end of the conference. [Operator Instructions]. As a reminder, this call is being recorded for replay purposes. Now, I'd like to turn the call over to Mr. Jake Elguicze, Treasurer and Vice President of Investor Relations. Please proceed.
Jake Elguicze:
Thank you, operator, and good morning, everyone, and welcome to the Teleflex Incorporated second quarter 2015 earnings conference call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing (888) 286-8010, or for international calls, (617) 801-6888, passcode 52181612. Participating on today's call are Benson Smith, Chairman, President and Chief Executive Officer; Liam Kelly, Executive Vice President and Chief Operating Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Benson, Liam, and Tom will make some brief prepared remarks and then we'll open up the call to Q&A. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors made in our press release today, as well as our filing with the SEC including our Form 10-K, which can be accessed on our website. The format for this morning's call will be as follows. Benson will begin with a high-level overview of our quarterly results and provide an update on some key strategic initiatives, including our manufacturing footprint consolidation program. We'll then turn the call over to Liam, who will review our product line and geographic revenue results, provide updates with regards to recent GPO and IDN developments, new product introductions and regulatory approvals and highlight two small acquisitions that we completed. Following Liam, will be Tom Powell. Tom will review our second quarter financial results and provide an update regarding our financial guidance for 2015. Before we begin, I'd like to point out that effective April 1, 2015, the company reorganized certain of its businesses to better leverage the company's resources. As a result, the company realigned its operating segments; specifically the company's Anesthesia/Respiratory North America operating segment was divided into two operating segments, Anesthesia North America and Respiratory North America. Additionally, the businesses comprising the company's former specialty operating segment which was included in the all other category were transferred to the Anesthesia North America, Vascular North America, and Respiratory North America operating segments. As a result of the operating segment changes, the company now has the following six reportable operating segments
Benson Smith:
Thanks, Jake, and good morning, everyone. During the second quarter, Teleflex continued its very solid operating performance building upon the results realized over earlier in the year. Once again, the company generated mid-single-digit constant currency revenue growth and achieved adjusted earnings per share that was slightly higher than our most recent internal projections. This was no small achievement as foreign exchange was a significant year-over-year headwind. As we entered the year, we forecasted that all the second and the third quarters would have extremely unfavorable comparisons to the prior year regarding FX. Therefore, Tom, will spend a little more time than usual walking you through how FX affects our P&L, and more importantly, why we expect substantial improvements in the as-reported numbers in the fourth quarter. By way of example, absent currency, our second quarter 2015 adjusted earnings per share would have shown a 14% increase over the prior year period. This is an indication to the underlying base business leverage that we are achieving. And while Liam and Tom will go into more detail during their prepared remarks, let me provide you with a brief overview of our quarterly results. I also want to bring to your attention one other circumstance that had an impact on our numbers this quarter. At the very end of the quarter we had two recalls. Now, normally we would not call out a recall as an offsetting event, as part of the medical device history and when you have one you take the hit. The only thing that makes these unusual is timing. Normally, when you have a recall, you issue a credit to your customers and then ship in replacement product when it becomes available. But because of the timing of these two recalls, we were unable to ship out replacement product and unable to fulfill other orders in hand for the product. Second quarter 2015 revenue totaled $452.1 million, which represents an increase of 4.7% on a constant currency basis. Having been able to ship replacement product during this quarter, our constant currency revenue growth would have been approximately 5% and that number does not include the benefit of shipping additional products if the products were not on product hold. I draw attention to this, because our revenue trajectory is an important element in our fourth quarter and that trajectory is better than what the 4.7% would lead you to. In the quarter, we saw improved results stemming from Asia, we saw a sequential rebound in sales generated out of China, continued benefits from the recent acquisition of Human Medics, and improved results from our business in Japan. Other right path this quarter included a vascular business, which grew almost 6%, our OEM business, which grew 7.5%, and our surgical business which generated almost 8% constant currency revenue growth. Our surgical business is starting to see increasing sales in our chest drainage product line. As a reminder, chest drainage product sales have been an area that Teleflex had been deemphasizing over the past several years due to the fact that these products have low gross margins. While our main competitor is currently operating under a consent decree and in order to meet the patient and provide their need, Teleflex is making every one of these we can. As we move through the remainder of 2015, we continue to expect to generate additional revenues of chest drainage products. While this is good from a revenue growth and earnings per share perspective, this will pressure our gross margin line particularly, in the fourth quarter. Turning to adjusted earnings per share, second quarter 2015 adjusted EPS was $1.42 that compares to second quarter adjusted EPS of $1.51. As I stated a few minutes ago, second quarter adjusted earnings per share was negatively impacted by foreign exchange by approximately 20%. If not for FX, adjusted earnings per share would have increased approximately 14% over the prior year period. This underlying operational improvement in year-over-year adjusted earnings resulted from higher volumes, favorable product mix coming from areas like Vidacare and Hem-o-lok, and the impact of recently completed acquisitions and distributor conversions. However, during the second quarter adjusted earnings per share was somewhat offset by additional manufacturing cost incurred due to the product recalls I just mentioned. These recalls impacted our gross and operating profits by approximately $3.6 million and gross and operating margins by approximately 70 basis points and 80 basis points respectively. We do not expect these recalls have an impact during the remainder of the year. Moving on, I would like to next provide you with an update on the status of our manufacturing footprint consolidation plan. We continue to believe that this program will be substantially completed by the end of 2017, and expect to generate annual savings of between $28 million and $35 million once the plan is fully implemented. These expected synergies are consistent with our initial expectations, which were laid out in 2014. On our last earnings call, we discussed the impact of foreign exchange as it was having on our year-end gross margin targets. Specifically, we said that when we entered the year we had a reasonable cushion in meeting our end year 55% target. However, given the more aggressive decline in the euro during the first quarter essentially that cushion disappeared. As we sit here now, two principal factors are causing us to revise our expectations regarding year-end gross margins. The first has to do with certain components relating to kits being transferred to Mexico. Earlier in the year, we identified substitutions for components that have been available in United States, but were not available in Mexico. Well, recently we have discovered some components that are much superior. And after significant market testing, we believe that the best alternative is to switch to those superior components. This will require some adjustments to the internal tray, which houses those components, and will push out the timeframe to having them available into next year. We look very closely at doing this in a two stage process. But given the relatively short timeframe involved, came to the conclusion that it was not cost effective and would introduce an added layer of confusion to the customer. The second issue impacting our expectations for fourth quarter gross margin is mix. When we project our revenue growth for the balance of year, we are seeing strong growth in our OEM segment, in our respiratory therapy business, and in our chest drainage business. This is good news. But all three of these product categories carry lower gross margins than our other product lines. As a result of the decision to delay some of the kit repackaging, along with the additional gross margin pressure from FX, and our expected mix of additional OEM respiratory therapy in chest drainage product sales, we now project that we will achieve adjusted gross margin of approximately 54% for the fourth quarter of 2015 versus our original expectation of 55%. I know that many of you have consistently observed that this management team takes hitting our goals very seriously. So it pains me to advise you this. And the year is not over yet, so we will do everything reasonable to mitigate these circumstances and close that gross margin gap. I say reasonable, because this will only temporarily delay our ability to attain the 55% gross margin level. We remain committed to the achievement of the longer-term projects that we recently shared at our Analyst Day and do not see any change in our ability to reach those longer-term objectives. In fact, we have growing confidence around some of the margin improvement opportunities that we did not include in our long range plans. I also say reasonable because the mix in adjusted margin does not translate into a mix in our adjusted operating margin line for 2015. The reason is that these low gross margin products that are affecting our mix also have very low operating expenses associated with them. In fact, despite this slight delay, we continue to expect that 2015 will be a strong year for Teleflex. And we are once again reaffirming our 2015 financial targets, which include generating constant currency revenue growth between 4% and 6%, adjusted gross margin of between 53% and 54%, adjusted operating margin of between 22% and 22.50%, and adjusted earnings per share between $6.10 and $6.35 per share in 2015. In summary, we feel very good about where we are in the year. And now, Liam, will provide you an update on our strategic business unit results.
Liam Kelly:
Thank you, Benson, and good morning everyone. For the consolidated company, second quarter 2015 constant currency revenues grew 4.7% and similar to the first quarter the revenue growth was broad-based both in terms of product lines and geographic regions. The major drivers of revenue growth this quarter came from improved sales volumes of approximately 262 basis points of revenue growth. This growth was driven by core product growth of 215 basis points, and Vidacare growth of 47 basis points. Vidacare product sales grew approximately 11% on a constant currency basis as compared with the prior year period. While this was good, it was lower than the growth we generated in the first quarter of 2015. The revenue growth rate of Vidacare product sales in the second quarter was down sequentially due to seasonality of military sales, and the timing of some crash car sales that occurred in the first quarter of this year. We continued to achieve approximately 30% revenue growth in the interventional products globally and nearly 20% growth in the EZ-IO products in Europe. During the quarter we also had our first Italian ambulance conversion. We continue to invest aggressively behind Vidacare and we remain extremely bullish on the product's potential. In fact, we expect Vidacare revenues to grow approximately 20% on a constant currency basis for the remainder of 2015. Turning to core product volumes, the increase this quarter was led by improved Vascular, OEM, and Respiratory sales for a domestic perspective. Our CVC business grew approximately 10% globally in the quarter driven by market share gains and product upgrades in the U.S., Europe, and Latin America, and volume gains in Asia-Pacific. While from an international standpoint, core product volume growth was great in Asia, thanks to additional orders coming from China, as well as increased sales in Japan. During the quarter, we also experienced strong core product volume increases throughout Europe, as well as in Latin American markets. Another contributor to our revenue growth this quarter was the continued penetration of new products in the market place. During the second quarter, new product introductions contributed approximately 89 basis points of revenue growth. This was led by sales of our European EASK CVC kits, surgical product introduction stemming from our partnership with a robotics provider, sales of our AutoFuser Disposable Pain Pump, and sales of our Rusch Disposable LED Laryngoscope. Additional sales coming from new product introductions in the quarter were somewhat offset by a decline in new products sales within our vascular business. This was due to the product recall issue which Benson mentioned earlier, as it impacted sales of our ArrowADVANTAGE5 preloaded PICC. We expect new product sales within our vascular segment to rebound during the remainder of the year. Excluding this recall, constant currency revenue growth for the company coming from new product sales would have exceeded 100 basis points. Turning to pricing. During the second quarter the average selling price of our core products were flat as compared with the prior year period. Similar to recent quarters we were able to achieve price increases within our North American surgical business. However, this was offset by price pressures primarily coming from European markets. And finally, this takes me to the last component of quarterly revenue growth or the contribution we received from M&A and distributor-to-direct conversions. Revenue growth from these totaled approximately 114 basis points and was primarily due to the impact of distributor conversion. The performance in this area was consistent with that achieved in the first quarter of the year. It is important to understand that as we progress through the remainder of the year, we continue to expect the contribution to revenue growth from M&A and distributor conversions to accelerate. Next, I would like to provide some additional color surrounding our segment and product related constant currency revenue growth drivers. Vascular North America second quarter revenue increased 5.6% to $81.2 million. The increase in vascular revenue was largely due to greater sales of Central Venous Catheters, Vidacare EZ-IO devices, and catheter navigation products. Moving to Anesthesia North America. Second quarter revenue was $45.6 million or flat versus the prior year period. Growth in this segment during the quarter was achieved in our LMA MAD Nasal atomization product offering. However, this was offset by the discontinuation of some third-party distribution agreements which was approximately 1%, lower sales in some of our region Anesthesia products, and lower domestic sales of laryngeal mask. And speaking of MAD Nasal, we recently received regulatory approval to expand our indication for use from a CE MAD perspective to include emergent, urgent, and medically necessary situations and when intravenous or intramuscular access may be difficult or impossible. Turning to our surgical North America business, its revenue increased 7.8% to $40.5 million. The increase in surgical revenue was due to higher sales of chest drainage, ligation clips, access boards, and Mini-Lap products. This was somewhat offset by lower sales of general surgical instruments and suture products. EMEA revenues totaled $129.1 million in the quarter and generated consistent currency revenue growth of 1.7%. This was consistent with the performance this segment realized in the first quarter and we continue to see the European market as being stable, with the increase in revenue this quarter, primarily due to higher sales of vascular products, including Vidacare and PICCs, higher sales of laryngeal masks, and increased dialysis access product sales. Moving to Asia, our second quarter revenue increased 9.4% to $62.1 million. The quarterly increase in Asia revenue was primarily due to stronger sales in China, go-direct efforts in Japan, and additional revenues in Korea due to the acquisition of Human Medics. Now to OEM. Revenues in the second quarter increased 7.5% to $37.9 million. The increase in OEM revenue was primarily due to higher sales of catheter products. And lastly, our all other segment revenue for the quarter was up 6%, totaling $55.7 million. The increase in other revenues was largely due to higher sales within Latin American countries and intra-aortic balloon pumps and catheters. Next I would like to update you on additional group purchasing and IDN agreements that we received in the quarter. In a similar fashion to the first quarter of the year, during Quarter 2, we once again won a total of 10 agreements. Of these agreements, four were brand new, while six were renewals of existing awards. One of the new GPO wins was for our Pleur-evac chest drainage products that Benson referred to earlier. The rest spanned across our product offerings that included items such as CVC and arterial access devices, intra-aortic balloon products, dialysis access and vascular positioning systems, and a brand new award for an AutoFuser disposable pain pumps. We continue to be quite pleased with the progress we are making in these areas. Next, I would like to update you on some recent product regulatory approvals that we received, as well as the findings from some independent studies that were performed in which our products were used. During the second quarter, we received 510(k) market clearance from the FDA for our Arrow Endurance Extended Dwell Peripheral Catheter System. Endurance was one of the products that we highlighted at our recent Investor Day event. This device is a single use peripheral catheter system intended for short-term dwell use to permit delivery of infusion therapy, pressure monitoring, high pressure injection, and the withdrawal of blood. The insertion device consists of an ergonomically designed handle with an integral echogenic needle. The needle has a passably active production mechanism, guide wire, release tab, and single-lumen catheter. The insertion device is designed as a closed system intended to contain blood throughout the catheter insertion process. The concept behind the Arrow Endurance system is that it will be used when a PICC may be too much for patient, but yes a peripheral IV device is not enough to solve their needs. It is our belief that through the innovative insertion design of this product that we can target a portion of peripheral IV market and turn that usage over to Endurance. We are quite excited about this product's opportunity and tend to launch it in the United States later this year. Another area of focus at the recent Investor Day surrounds our leadership position within the area of antimicrobial and anti-thrombogenic coating and helping hospitals minimize the cost associated with hospital acquired infection. Recently our Arrow Central Venous Catheters with ARROWg+ard Blue technology were included in a peer review retrospective study. The study further documented the ability of our Central Venous Catheter with ARROWg+ard Blue technology to prevent catheter related blood stream infections therefore reducing their occurrence and reducing direct cost associated with treating those infections. The antimicrobial catheter outperformed an unprotected CVC in both infection prevention and total cost per patients. Within this study, the ARROWg+ard Blue catheter achieved a zero infection rate per 1000 catheter days. In contrast, the unprotected device was associated with a higher catheter related blood stream infection rate. In addition to superior clinical performance the ARROWg+ard Blue CVC had sharply lower CVC related costs than those associated with an unprotected catheter. This study is further evident that using an unprotected catheter may put both the patient and hospitals bottom-line at unnecessary risk. And before I review two recently completed acquisitions, I would like to provide an update on the status of the LMA Protector and Percuvance product launches. The LMA Protector is the device that we've been working on which we expect would bridge the remaining gap with ET tubes and open up a large number of additional procedures both in the pre-hospital and hospital settings to LMA use. This is important to Teleflex as the margin mix benefit that would get from the migration from ET tubes to LMA use is significant. The protector has a flexible but fixed curb tubes that allows ease with surgeons and anatomical conformity. It's patented dual gastric drainage channel and chamber is designed to improve the laryngeal seal during high volume regurgitation. It also has an integrated suction fore that can be used to rapidly remove any gastric content in the patient or to regurgitate during a procedure. The protector is currently being evaluated in 22 hospitals around the world as part of a small controlled limited market release. Feedback from these controlled releases has been overwhelmingly positive. The protector design is getting high marks for its seal pressure which is a critical component to protecting the airway and facilitating ventilation. In addition, the protector silicon design and flexible curb has been well received in terms of ease of insertion. Users have also reported high praise for the advanced gastric access feature. We are quite enthusiastic about this product and it is our belief that the protector can move Teleflex forward exponentially in our quest to provide physicians with technology that reduces the risk of area-related complications. We expect a full market release in the first quarter of 2016. Now to Percuvance. As a remainder it is our belief that Percuvance has a potential to eliminate scaring and pain and improve a patient's recovery when compared to a traditional multi-port laparoscopic surgery. This device eliminates the need for multiple trocars and allows the surgeon to potentially access the surgical site with better angle. The unique feature of Percuvance allows the surgeon to use similar size operating tip. The same size they have been accustomed to using the traditional 5 millimeter, 10 millimeter straight stick laparoscopic devices without the need for a trocar. The Percuvance surgical system was first used at the Cleveland Clinic in March of this year. I am pleased to tell you that since the initial launch in March, we are currently testing the product in nine hospitals worldwide today, and anticipate that we will have the device in 17 hospitals by the end of the year. Similar to the other main protector, I am happy to report that initial feedback on Percuvance has also been extremely positive. Our key findings from the limited market release are three folds. First, it has the applicability in a broader range of procedures. Second, it has applicability in more complex procedures than first envisioned. And third, the Percuvance system has a fast deduction rate as it does not require a change in surgical practice. Next, I would like to briefly discuss two small acquisitions that were recently completed. The first was the acquisition of N. Stenning & Co. Stenning has been a distributor of Teleflex surgical products in Australia under the Pilling and Weck brand for nearly 35 years. Included in this transaction as a Stenning surgical customer relationships throughout Australia and a team of surgical sales representatives were now employees of Teleflex. This acquisition is yet another example of Teleflex executing upon its strategy of converting select distributors to a direct sales model, enabling the company to leverage our sales performance to support growth and capture additional margin. These all cash acquisition was completed in June and is expected to be modestly accretive in 2015. And lastly, I would like to touch on another acquisition that will benefit our Anesthesia segment. Completed on the first day of the third quarter was the acquisition of exclusive North American distribution rights to the AutoFuser and the AutoFuser with AutoSelector range of disposable pain control pumps from Ace Medical U.S. In connection with this transaction, Teleflex entered into a 10-year exclusive distribution agreement with the manufacturer of these products Ace Medical Corporation. This transaction solidifies Teleflex's position as a leading source of high quality regional Anesthesia products, including catheters and pain pump systems and provides the immediate benefit of a strengthening our Anesthesia business in the United States and supports our margin expansion initiatives. This too was an all cash transaction and it is also expected to be modestly accretive to revenues and earnings in 2015. That completes my prepared remarks. With that, I would like to turn the call over to Tom. Tom?
Thomas Powell:
Thanks, Liam, and good morning everyone. Given Liam's discussion of the company's revenue growth drivers, I will begin my prepared remarks at the gross profit line. But before I do, I would like to reinforce a point made earlier by Benson, which is that underlying operating performance is solid. So far this year we have made progress against our gross margin efficiency initiatives, including footprint consolidation, host of new manufacturing cost reduction initiatives, and a continued conversion of select distributors to a direct sales model. We have reorganized several business units in order to drive SG&A efficiency and we have reduced the average borrowing cost through the redemption of higher cost notes. However, for the time being our operational progress is being matched somewhat by the impact of currency. For the second quarter, we estimate that the impact of foreign currency which reduced adjusted earnings per share by approximately $0.30. If we were to exclude the currency impact, earnings per share growth would have been approximately 14%. As I go through the quarterly results, I will highlight the currency impact so you can get a better understanding of the underlying operational performance. Turning now to results. For the second quarter, adjusted gross profit was $236.3 million versus $245 million in the prior year quarter. Adjusted gross margin was 52.3% which was flat when compared to the prior year period. During the second quarter we realized improved operational efficiencies from both manufacturing and logistics cost improvement programs, and the beginning stages of manufacturing consolidation. Recent distribution conversions in Japan, Korea, and now Australia, plus the acquisitions of Truphatek and Mini-Lap further boosted gross margin. Additionally, we realized favorable product mix, including strong results in the vascular North America segment. However, the underlying operational improvement in adjusted gross margin was offset was the unfavorable impact of product recall-related expenses that reduced gross margin by approximately 70 basis points, and foreign exchange rates that reduced gross margin by approximately 50 basis points. While we have not removed these items when calculating our adjusted gross margin, if you were to normalize our results for these impact, adjusted gross margin would have been approximately 53.5% in the quarter. Second quarter adjusted operating profit and margin were $92.3 million and 20.4% respectively versus $98.3 million and 21% respectively in the prior year quarter. The decline in adjusted operating margin was primarily due to the unfavorable impact of foreign exchange rates and recall expenses. These impacts more than offset efficiency gains from the recent reorganization of our North American specialty, anesthesia, and respiratory segments, as well as continued benefits from the 2014 restructuring our European country organizations. Similar to gross margin, if you would normalize our results to exclude the impact of currency and the product recall cost, adjusted operating margin this quarter would have been approximately 23%. Turning to second quarter, we also took steps to further optimize the company's capital structure through redemption of our 6% and 7.8% senior subordinated notes due in 2019. The redemption of these notes occurred on June 1, and was funded through borrowing under our revolving credit facility. As a result of the transaction, we anticipate that adjusted net interest expense will decline from the current level to approximately $11 million per quarter in the second half of 2015. The objective of this transaction was to lower our average borrowing cost, while maintaining the balance of fixed versus floating rate debt. Moving next to our adjusted tax rate. For the second quarter 2015, the adjusted tax rate was 19.5%, a reduction of 280 basis points compared to the prior year period. The year-over-year reduction is primarily due to a favorable shift of taxable income to jurisdictions with lower statutory tax rate. On the bottom-line, second quarter adjusted earnings per share was $1.42 or a decrease of 6%. As mentioned, if were to exclude the currency impact, earnings per share growth would have been approximately 14%. Turning now to select balance sheet and cash flow highlights. During the quarter, cash provided by operations was approximately $67 million, which is running a little bit behind year ago levels, largely the results of increased inventories and receivables in Japan as we transition the business to a direct sales model. We're expecting improvement in this area as the year progresses. On a full year basis we project cash flow from operations to both remain on target to exceed $300 million and to achieve growth at a level consistent with adjusted earnings growth. During the quarter, cash on hand increased by approximately $60 million to a quarter-end balance of $325 million and our U.S. cash balance was $27 million. Turning next to an update of our full year 2015 financial guidance. We continue to expect 2015 constant currency revenue growth of between 4% and 6% and as reported revenue growth of flat to down 2% as compared to 2014. As we look to second half revenues, we expect a currency headwind in the third quarter similar to what we experienced in the second quarter, but then a lessening impact in the fourth quarter given an improvement in the prior year comparables. Also during the second half of the year, we expect an acceleration of our constant currency revenue growth rate due to the continued positive impact from recently completed distributor conversions and M&A, gains from new product introductions, increased Vidacare penetration, and higher revenue growth coming from China, coming from an easier fourth quarter comparable. Also during the fourth quarter, we have one additional shipping day. We expect fourth quarter constant currency revenue growth to be particularly strong giving the building momentum, the easier comparable, and the additional shipping day, which alone is expected to contribute more than 100 basis points fourth quarter revenue growth. On a reported basis assuming currencies remain in their current range, we project our as-reported revenue growth to turn positive in the fourth quarter. Continuing down the income statement, we had previously guided 2015 adjusted gross margin to be in the range of between 53% and 54% for the year. We now project 2015 adjusted gross margin to be at the low-end of the range or approximately 53%. Revision is attributable to cost related to second quarter recalls and the recent decision to delay the transfer of some of the material packaging and kit configurations from the fourth quarter of this year to the first quarter of 2016, plus higher than budgeted sales of OEM and chest drainage products and ongoing currency headwind. The current projection represents an approximate 150 basis point improvement in the adjusted gross margin versus 2014 and includes an unfavorable currency impact that we estimate will reduce full year gross margin by approximately 70 basis points. We expect third quarter adjusted gross margin to improve sequentially from the second quarter with further improvement projecting the fourth quarter to approximately 54%. Moving on to adjusted operating margin and earnings per share. For full year 2015, we continue to expect adjusted operating margin to increase by approximately 200 basis points to 250 basis points to a range of 22% to 22.5%. Based on recently implemented SG&A expense reduction actions, including the reorganization of our North American Specialty, Anesthesia and Respiratory commercial operations, plus restructuring of our European finance and marketing organizations, we expect SG&A expenses as a percentage of revenue to decline in the second half of 2015, as compared to the first half of the year. As a result, we expect improved SG&A expense leverage that will offset the gross margin move and thereby allow us to maintain our previously provided range for adjusted operating margin. Similar to gross margin, the gains we expect to generate at the operating margin line will be negatively impacted by foreign exchange and we estimate that the full year 2015 operating margin would've been approximately 100 basis points higher, if were not for foreign exchange headwinds. Moving on to taxes. We continue to expect our full year adjusted tax rate to fall within the range of 20% to 21%. On the bottom-line, we continue to expect adjusted earnings per share to be within the range of $6.10 to $6.35 per share. And that fourth quarter will be considerably stronger than our third quarter. In closing, we continue to be encouraged by the progress made towards our operational goals and objectives. Our revenue growth is tracking to expectations and our volume trends continue to improve. While factors have caused this to moderate somewhat on our gross margin exceptions, we now expect to overachieve in other areas and thereby remain on track to reach both our 2015 operating margins and earnings per share targets. That concludes my prepared remarks. At this time, I'd like to turn the call back to the operator for questions. Operator?
Operator:
Thank you. [Operator Instructions]. Our first question comes from the line of Larry Keusch of Raymond James. Please proceed.
Larry Keusch:
I'm wondering, Benson, if we could start with the chest drainage product and the comments that you made. I understand that these are obviously incremental revenues, albeit at a lower margin. But could you help us understand how you're thinking about perhaps the size of the market or the opportunity? And how should we be thinking about as that being incremental to the 2015 outlook?
Benson Smith:
So just by way of background as I mentioned in my prepared remarks, there is a consent decree -- excuse me that is affecting the largest competitor out there. When the impact of that started to became apparent we began a series of negotiations with GPOs and IBNs and essentially came to some agreements with those customers for essentially a three-year agreement. So we expect to ramp up to our full production capability and are in the process of doing that and expect the whole -- the majority of that business over a three-year period. We are not, however, making additional investments to expand our production beyond that point. We're really driven by this -- by patients and customer concern more so than an economic opportunity. So while we expect all lines of the business for three-year period it still falls into that category of low gross margin products that longer range we don't think our strategic best area of investment.
Larry Keusch:
Okay, that's helpful. And then I guess the second question is just on M&A. And I guess the question is how are you viewing the opportunities out there? It seems to me, given the strength of the business that you probably don't have a major sense of urgency to get a deal done. But just want to take your temperature on what the environment feels like, what do valuations feel like, and is this still a priority for you guys?
Benson Smith:
So the short answer to your questions is yes. We -- I would just tell you we've never been busier. We are working on a number of smaller deals two of which -- of the kinds that Liam announced and those are typically deals we have much higher degree of certainty and being able to move across the finish line. But there is a lot of activity in that range where we're looking at for acquisitions right now. But timing is always hard to predict, but it remains the high priority for us.
Larry Keusch:
Okay. And just lastly on that, just in terms of size of deals, just how should we -- I understand the smaller ones, but assuming something a bit larger, should we be thinking more like Vidacare, LMA sizes, that $200 million?
Benson Smith:
So when possible I would say that's the size we prefer. I think all along we've said we were going to go up to something in the range of a purchase price of, let's say, $500 million plus for the right opportunity. So I think the answer to your question is we still prefer those $100 million revenue size acquisition, they are a little bit easier to integrate. But it's a very opportunistic situation and sometimes things become available that are still attractive and fall a little bit on the larger side of that.
Operator:
Okay. Thank you. Your next question comes from the line of David Lewis from Morgan Stanley. Please go ahead.
Jon Demchick:
Hello. This is actually Jon Demchick in for David.
Benson Smith:
Hey, Jon.
Thomas Powell:
Good morning, Jon.
Liam Kelly:
Hi, Jon.
Jon Demchick:
Good morning. Wanted to follow up on Larry's question on the chest drainage opportunity. And I think you mentioned that you expect to hold onto that business for the three-year timeframe, which I guess coincidentally, follows quite nicely to the long-term plan that you guys mentioned at the Analyst Day. And then, it sounds like the chest drainage opportunity has the potential to impact gross margins by about 100 basis points into the fourth quarter. So obviously, there's some sort of an offset onto the operating line with less selling costs, but should we expect this to impact the gross margin expectations over the next few years?
Benson Smith:
So just to be clear, the 100 basis points declined from 55% to 52% -- to the 100 basis point you're referring to really included some of the impact from the delay of the transfer of kits and also some impact from our greater than expected respiratory therapy volumes and OEM business. So not all of that decline is due to the chest drainage business.
Liam Kelly:
And Jon, I'll just give you a bit of color on the chest drainage. It -- the largest GPO win that we executed on implementation just began during the month of July.
Jon Demchick:
Okay. Understood. Is there a way to quantify maybe like the impact that the chest drainage business should have on your gross margins overall?
Benson Smith:
I would say that's getting too finite given all the things to go into the bucket that end up in our gross margins column. But I would say that whatever it turns out to be the impact that it ends up having on our operating margins is negligible.
Jon Demchick:
Okay. That's very understood. One of the big surprises, at least for us, from the Analyst Day was the confidence towards organic growth acceleration in the out years. And I think a big part of that is the pipeline. As Liam mentioned on the call, both Percuvance and the LMA Protector are going to be big contributors to that. With those products launching at the beginning of the years, I was wondering if you could maybe help us think about the growth contribution you're expecting from these products into driving acceleration into 2016.
Liam Kelly:
So we will launch them, we'll come up the limited market release in quarter 2016 for both products. As we said in the Analyst Day, the size of the market for, in particular, the Percuvance is in the region of $300 million to $400 million. The adoption rate we expect to add that it will accelerate during the quarter one through. So we expect an impact in 2016, but we're expecting more significant impacts on revenue growth for that particular product in '17 and '18 as it starts to get some traction. We will have it in 17 hospitals, as I said, at the end of the year. And for the Protector, we are expecting a similar ramp up, slower ramp up in '16 and then accelerating into '17 and '18. Again, I won't get too granular on the details in this particular product line at this time.
Benson Smith:
Jon, I would tell you that one of the reasons we have this almost like a test-market release going on is so that we can have a better perspective as we plan for 2016 and what the likely volumes are going to be and spend accordingly to be able to make that happen. I would say our accelerating product line though, particularly in the shorter term 2016 has as much to do with what we see as volume growth in the U.S. market and share gains. We're seeing that essentially across most of our business units and particularly areas in the vascular arena where we're seeing a good growth. In fact, we saw some of the strongest underlying constant currency growth in those segments already through the first two quarters.
Operator:
Your next question comes from the line of Matt Mishan from KeyBanc. Please proceed.
Matt Mishan:
I think you're halfway through the year at this point, but you still maintain the guidance and it's still a pretty wide range. I'm just curious why you weren't able to narrow that a little bit.
Benson Smith:
Matt, are you referring to -
Matt Mishan:
EPS, that’s right.
Thomas Powell:
The revenue range or the earnings range?
Matt Mishan:
EPS, yes.
Thomas Powell:
Matt, why don't I take that one. So as we thought about it a year, we've got a fairly significant acceleration of revenue, margin expansion and savings and synergies coming to fourth quarter. So we wanted to make sure, we've got no better visibility on that, better understanding what's happening with currencies. But certainly we'll look to narrow that range as we get in the third quarter.
Benson Smith:
I would just add from my perspective currency continues to be our biggest unknown factor. It bounces around $0.03 or $0.04 within a week. So there is a lot of volatility there. I think if we just look at a constant currency revenue projection, I would say, I'm pretty comfortable that we're going to certainly be in the upper half of our guidance range as in the lower half. We really just need to kind of see what happens with the FX in the fourth quarter to be able to understand how much of that’s going to translate into EPS.
Matt Mishan:
And on the R&D level, for the second quarter in a row that looks like it's about 3% of sales. Are you just seeing less -- why such a low level? Are you seeing less projects to invest in or is it -- I'm just curious?
Thomas Powell:
Yes. So we are continuing to make investments in late-stage technology opportunities that is supplementing that a good bit. So I think our overall investment for the year when you're taking both things into consideration is more than adequate to be able to propel what kind of revenue growth we're projecting.
Matt Mishan:
Okay, and lastly on Percuvance, I think you mentioned that you thought it would be applicable in a broader range of procedures and more complicated procedures. Could you just elaborate on that a little bit? And I know you mentioned the LMA is a full market release in 1Q '16. Are you still comfortable that you'll do a full 1Q '16 launch of Percuvance as well?
Benson Smith:
Okay. I'll take that. Yes. To your last question, yes. We're very comfortable we're going to get product out there in Q1. Everything is tracking to plan, our internal plan. When we started, we thought we would with doing a lot of procedures in live coli, but in actual fact, we have done as many bariatric and gynecological procedures as we've done live colis during the e-test. And the surgeons are more aggressive in the procedures they would use it in, which is for us quite exciting. Because if it's in a more complex procedure, it's what we would refer to as stick your product in the longer term.
Operator:
Your next question comes from the line of David Turkaly from JMP Securities. Please go ahead.
David Turkaly:
I guess just given your performance in the quarter on that pricing side, any update there in terms of your expectations moving forward? Do you still think you can get price as a contributor?
Benson Smith:
So I think we have indicated over the past couple of quarters that the majority of our pricing is going to come from fewer direct conversions. For example, chest drainage, we might have had an opportunity to raise our prices given the emergency, but we thought that was sending the wrong message to our important GPO customers. The circumstance in Europe just with the addition of what's happening in Greece, what's happening in Russia, et cetera is eliminating some of the other parts of price moves that we're making? So we would continue to suggest that we're in that 100 basis product range over the next couple years, but the majority of it's going to be coming from dealer-direct conversions.
David Turkaly:
Great. And then on the Arrow Endurance, I guess, do your competitors have a product that's similar to that, or is that a new category that you're creating there?
Liam Kelly:
There are other products within that category that we compete with. But we believe that our insertion process is quite unique and differentiated and will move some of the IB market into that space.
David Turkaly:
And last one from me, just any details that you'd be willing to share on the Australia distributor, either headcount or revenues, anything like that that you could help us out with would be great? Thanks.
Liam Kelly:
On the Australian dealer to direct, so what we need to do is bleed through their inventory during this quarter and you should see about in the region of 50 basis points to top-line growth in the fourth quarter.
Operator:
And your next question comes from the line of Matt Taylor from Barclays.
Ian Mahmud:
This is actually Ian Mahmud in for Matt. Can you hear me okay?
Benson Smith:
Yes.
Liam Kelly:
Yes. Good morning.
Benson Smith:
Good morning.
Ian Mahmud:
Okay, great. Good morning. So our question is actually following up on Dave's question about the purchase of the Australia distributor. And we were just wondering if at this point you can maybe size the opportunity for Teleflex in terms of the purchase of more distributors and what your thoughts are on that at this point?
Benson Smith:
What we've continued to say, for a while, I'll just repeat it, is their cadence of distributor-to-direct conversions [indiscernible] couple of years is what we've forecast over the next couple of years. There continues to be opportunities that are more than enough to be able to support that level. It's really more problematic for us to get down to the individual details about any single one of these. But in terms as an overall annual impact, what we've been delivering over the past couple of years is what we expect to deliver over the '16 through '18 timeframe that we outlined at the Analyst Day.
Ian Mahmud:
And just as a follow-up, one of the products that we like from a margin perspective is MAD Nasal. Do you have any update on that or anything that you can share from your current thoughts?
Liam Kelly:
So, as I said during my prepared remarks we just got extended indications in Europe so for emergent use of the product. We continue to invest heavily behind this product. We are very pleased with the growth rate within the product that we're experiencing at the moment and we see the growth within the quarter in the high double-digits globally. So, it's one of the products that's within our area of focus and we continue to look to get more indications for use for the product.
Operator:
Okay, thank you. And our next question comes from the line of Anthony Petrone from Jeffries. Please proceed.
Anthony Petrone:
Well thanks, gentlemen. Couple P&L questions, and then a few product questions. Maybe just a reminder, Benson or Tom, on the $28 million to $35 million in cost savings, how that we should expect that to roll through the P&L over time and sort of where the majority of the savings will be realized? I would assume COGS, but is there some that's allocated to the operating lines? And then one just for this year, on the pain pump distribution agreement that you mentioned in the prepared remarks, Benson, that's immediately accretive. Just wondering what should we expect this year in terms of accretion from those deals? And then, I've a couple of follow-ups.
Thomas Powell:
So, in terms of the $28 million to $35 million it's largely savings that's going to show up in the COGS in gross margin line. There really isn't anything below that associated with that program. In terms of the timing, we spoke about a bit of that starting to happen in 2015 largely in the third and then in the fourth quarter. We've now moved manufacturing for some of our dry kits and VasaNova down to Mexico. So we're going to start to realize those savings in the third and fourth quarter of this year. The majority of the savings however will be kind of realized in 2016 and then a couple of million dollars more in 2017. So I think next year is kind of the lion share of the gain.
Benson Smith:
Relative to the pain pump question, it's a couple of pennies towards the end of the year. We obviously have to believe through our existing inventory. I think the two things that were quite attractive to us about this is, this is a extremely attractive product compared to the market leaders product that's out there, and by negotiating this deal for the distribution rights in the United States it improves our gross margins from one of the lower gross margin products in our bag to one of the higher ones. So few cents this year it will be much more favorable to us next year.
Anthony Petrone:
That's helpful. And then just a couple to round it out on products. On Vidacare, maybe just an update on where the Greenfield opportunity there is. Are there still hospitals in the U.S. that you can still penetrate? Or is it more just increasing usage at existing sites? And then maybe just a quick update on Weck disposable trocars with Intuitive Surgical. Intuitive had a pretty good quarter with volumes and placements. I'm just wondering how that plays out over time. Thanks.
Liam Kelly:
Yes, so I'll take the Vidacare question first. So and it was always the case when we bought Vidacare that we realized that the opportunity to expand was in the ambulance service in Europe particularly and we were very pleased to convert our first ambulance service in Italy during the quarter as I said during my prepared remarks. There is still significant penetration opportunities within the United States and particular with the hospital segment. And we had a recent publication of a paper that showed that for emergent vascular access that even compared to CVC, EZ-IO was a better opportunity, a better methodology of getting immediate access for the vasculature. So we continue to see opportunities within the EMS segment, within North America, within the hospital segment, within North America, within the European EMS segment, and also within Asia-Pacific where it's in its infancy within Asia-Pacific and in the future that's a long-term growth prospect for us. So we continue to be very bullish about potential growth with EZ-IO and the Vidacare products and if we look at the half year, we are in the region of 20% growth within the half year base and we anticipate that to continue throughout the remainder of the year as I said in my prepared remarks. Your second question was regarding to the trocars. And this is one of the significant drivers behind our product growth which I said was 84 basis points within my prepared remarks. So this continues to be a focus for us and we're very, very pleased with the partnership that we had with Intuitive. And I think Intuitive likewise are very pleased with the partnership with Teleflex.
Operator:
Okay, thank you. Your next question comes from the line of Jason Wittes from Brean Capital. Please go ahead.
Jason Wittes:
I wanted to ask first just a more clarification on gross margin. The component kit issue, is that a one-quarter delay type issue, or is that something that's going sort of continue into next year?
Benson Smith:
So -- our this is a relatively recent decision that we just arrived at a week or so. The current estimate is that is about a quarter delay. So we expect to get into manufacturing that product by the end of first quarter, it obviously won't have much impact on our gross margins in the first quarter that will follow that. But that's about the time it's going to take us to do the reconfiguration of the packaging and get through the validation process.
Jason Wittes:
Okay, and sounds like you're not necessarily able to quantitate what the chest drainage opportunity might be it terms of -- it sounds like it's going to be accretive to overall margins, but for gross margins it will be dilutive. And I guess you're not in a position to necessarily quantitate that at this point. Is that the right way to think about it?
Benson Smith:
So, yes. I think we'll have a much better perspective on that in terms of the surrounding detail by the end of third quarter. We're in the practice of ramping up manufacturing that has an added cost that aren't going to stick around I think once we get to those levels but we'll have a much clearer picture about that certainly by the end of the year, most likely by the end of the third quarter.
Liam Kelly:
And as I said during my earlier comments we're just in the process of converting the largest GPOs following the win. So we’ll have much more clarity on that as we go through the next quarter.
Jason Wittes:
Okay, fair enough. And just did you give an indication of how PICC and CVCs did this quarter?
Liam Kelly:
Yes, I gave an indication of CVC. CVCs grew 10% globally and that was really consistent across all the geographies. PICCs were impacted by the recall, as I mentioned during my prepared remarks, and overall were 8.1% of growth.
Benson Smith:
Yes, PICCs were -- Jason, PICCs were down about 8% in the quarter and that's really coming from the product recall issue that we referred to earlier. Had it not been for that we would be more in line with where we were in prior quarters.
Jason Wittes:
Okay. And then the last question on ARROW Endurance. How big is the market today for these type of products? Sounds like there's some other products out there and how big do you expect it can grow to?
Liam Kelly:
Well, if you look at the total IV market, and Jason, I'm not suggesting you do this --
Jason Wittes:
Fair enough.
Liam Kelly:
That would be a $300 million $400 million market but the segment of the market that we're targeting is in $40 million to $50 million entire segment that we're posting this product on is it's a in between a peripheral IV and a PICC. And what you see happen is some of the IV segment moved to the Endurance and some of the PICC segments moved to the Endurance.
Operator:
Okay, thank you. And our next question comes from the line of Richard Newitter from Leerink Partners.
Ravi Misra:
Hi. Good morning, thank you for taking the questions. This is Ravi here --
Benson Smith:
Richard, we can barely hear you.
Ravi Misra:
Good morning, can you hear me now? This is actually Ravi in for Rich. Is that better?
Benson Smith:
A little better.
Ravi Misra:
Okay, may be some headset. So I wanted to follow-up on the recall. I was hoping if you could quantify that a little bit, given you said about 30 BPs in the quarter. How do you see that going forward on the top-line and any commentary on when you see that resolving? And then may be one on FX exposure. It sounds like what you're saying is that Europe at least seems to be doing okay. But I was just curious if you could just quantify a little bit about your currency exposure, what are the components of that? Thanks.
Benson Smith:
So, relative to currency we have made our balance for the year projections assuming a dollar euro at $1.08. One of the impacts of currency in the second quarter had more to do with the euro versus other currencies. And that introduces a layer of complexity that makes projections I would just tougher to do. If we were only concerned about the dollar-to-euro number it would a lot easier to answer your question. But by way of example in the second quarter we had also budged it at about $1.08 and I think the actual average number was a $1.10, but we saw more unfavorability from currency than what we expected because of the euro in relationships to other currencies.
Thomas Powell:
So let me provide a little more details around our exposures and help you better understand. So Benson probably touched on euro which is our biggest exposure. We do about 30% of our business in euros. Our next biggest exposure is really less than 5% of our revenue. So if you look at some of those other areas where we are exposed its Australia dollars, Japanese yen, Chinese yuan, Canadian dollar, British pound. So we don't have any significant exposures outside of the euro and that's why we tend to focus on it quite a bit. Now, for us in terms of exposure, we have the greatest exposure related to translation. We don't see big transactional and other issues impacting us. We've talked about a full year exposure on the range of about $0.85 or so. Now, you may say boy, second quarter you set was around 30 and the reason for that is twofold. First of all we see the greatest currency exposure with the euro in the second quarter, just given how rates moved last year, beginning the fourth quarter we're going to start to get a more favorable comparable. So that will help us on that front. And then I forgot the other point I was going to make related to the currency here. But in any event as we think about those impacts it's really second quarter is going to be our greatest impact as we get into the third quarter, it will abate a little bit, and then the fourth quarter even more so. So full year the impact that would be $0.05, it's largely driven by the euro and again the second quarter we expect to be the greatest impact.
Benson Smith:
To answer to your question about the recalls, first of all we've obviously booked the extent of receiving the merchandise back in the second quarter; we will re-shift that to customers, and will be in a position to have the product come off product hold in the third quarter. So we'll see a benefit in terms of some revenue coming from that. The cost of rework essentially we've booked in the second quarter and that should not have, it will obviously get calculated into our overall year-end gross margin number but we should not see any residual effect from that in the third quarter or in the fourth quarter.
Operator:
Okay, thank you. We have no more questions at this time. [Operator Instructions]. As we have no more questions coming through, I would now like to turn the call over to Jake Elguicze for closing remarks.
Jake Elguicze:
Thanks, operator, and thanks to everyone that joined us on the call today. This concludes the Teleflex Incorporated second quarter 2015 earnings conference call.
Operator:
Thank you for your participation in today's conference. This concludes the presentation. You may now disconnect. Good day.
Executives:
Jake Elguicze – Treasurer and Vice President-Investor Relations Benson Smith – Chairman, President and Chief Executive Officer Thomas Powell – Executive Vice President and Chief Financial Officer Liam Kelly – Executive Vice President and Chief Operating Officer
Analysts:
Larry Keusch – Raymond James John Demchak - Morgan Stanley Yong Lee – Barclays Dave Turkaly – JMP Securities Matthew Mishan – KeyBanc Jason Wittes – Brean Anthony Petrone – Jefferies Ravi Misra – Leerink Partners
Operator:
Good day, ladies and gentlemen and welcome to the Quarter One 2015 Teleflex Incorporated Earnings Conference Call. My name is Emma, and I will be your operator for today. At this time, all participants are in listen-only mode. We will conduct a question-and-answer session towards the end of this conference. [Operator Instructions] As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Mr. Jake Elguicze, who is Treasurer and Vice President of Investor Relations. Please proceed, sir.
Jake Elguicze:
Thank you and good morning, everyone, and welcome to the Teleflex Incorporated first quarter 2015 earnings conference call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing 888-286-8010, or for international calls, 617-801-6888, pass code 72082025. Participating on today’s call are Benson Smith, Chairman, President and Chief Executive Officer; Thomas Powell, Executive Vice President and Chief Financial Officer; and our newly appointed Executive Vice President and Chief Operating Officer, Liam Kelly. Benson, Liam, and Tom will make some brief prepared remarks and then we’ll open up the call to Q&A. Before we begin, I’d like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors made in our press release today, as well as our filing with the SEC including our Form 10-K, which can be accessed on our website. I would like to point out that the format for this morning’s call will be slightly different than our past earnings conference calls. Benson will begin with a high-level overview of our quarterly results and provide an update on some key strategic initiatives, including our manufacturing footprint consolidation program. Who’ll then turn the call over to our newly appointed Chief Operating Officer, Liam Kelly. Liam, who has been in executive roles at Teleflex since 2009, will review our first quarter product line and geographic revenue results, provide updates with regards to recent GPO and IBN developments, new product introductions and regulatory approvals and highlight two small acquisitions that we completed. Following Liam, will be our Chief Financial Officer, Tom Powell. Tom will review our first quarter financial results in more detail and also provide an update regarding our financial guidance for 2015. And finally, we will open up the call to Q&A. With that I’d like to now turn the call over to Benson.
Benson Smith:
Thanks, Jake and good morning, everyone. Let me start by saying that we are very pleased with our overall first quarter results and are off to a strong start to the year. From an operational standpoint, our execution against key priorities this quarter was excellent. And for the third quarter in a row, we continue to see strengthening revenue growth in North America. And while FX continues to be a challenge, we’ve been successfully mitigating impact on our adjusted EPS line. In light of the substantial volatility and currency, we have been encouraged by our investors to be transparent as to how FX is affecting us on our important financial metrics, and to provide easy visibility into our underlying business performance, as well as highlighting, the impact of currency having on those results. During the course of our presentation, we’ll therefore be commenting on our results with and without the effects of currency throughout the P&L. First quarter 2015 revenue totaled $429.4 million, which represents an increase of 5.2% on a constant currency basis. Action the impact of currency or as reported revenue would have totaled $461 million. Additionally, we had one less shipping day in the first quarter of 2015 as compared with the prior-year quarter. If you were to adjust for the shipping day impact, our constant currency revenue growth would have been approximately 6.2%. And while Liam will discuss in greater detail our revenue breakdown by business segments, I want to point out that our constant currency revenue growth in North America was 6.7%, adding in for the shipping day we lost, our constant currency revenue growth in North America would have been over 8% and there is no impact from distributed to direct conversion on those numbers and a very modest impact from acquisitions. As such, we attribute the majority of this growth to market share gains and the continued expansion of Vidacare. On an operational basis, these results were better than our initial expectations, as we generated constant currency revenue growth within each of our reportable segments and this included several segments reported – reporting upper single digit constant currency revenue growth rates. Turning to adjusted earnings per share, first quarter 2015 adjusted EPS was $1.30. That compares to the first quarter of 2014 adjusted EPS of $1.22 or an increase of 6.6%. Similar to our constant currency revenue growth performance in the quarter, adjusted EPS was also a slightly better than our initial expectations. The improvement in year-over-year adjusted earnings resulted from higher volumes, continued improvement in average selling prices, favorable product mix and the impact of recently completed acquisitions. In addition, we continue to generate increased leverage to the income statement from a lower adjusted tax rate when compared to the first quarter of 2014. These year-over-year increases were somewhat offset by the negative impact of foreign currency, which impacted our adjusted EPS. But it not been for the unfavorable impact of foreign exchange, adjusted earnings per share in the first quarter of 2015 would have been $1.39 or an increase of approximately 13.9% versus the prior year period. Next, I would like to provide you with an update on the status of the manufacturing footprint consolidation plan that we initiated approximately one year ago. As a reminder, the facility restructuring plan was developed in response to pressures that companies like Teleflex is spaced in the healthcare industry and was designed to improve our competitive position. The plan is focused on the consolidation of operations from three higher cost locations through existing lower cost Teleflex locations and results in reduction in work force. I am pleased to say that these key strategic initiative remains on track in terms of both the expected timetable to complete and the anticipated project synergies. We continue to project that this program will be substantially completed by the end of 2017 and expect to generate annual savings of between $28 million and $35 million once the plan is fully implemented. From an operational standpoint, we are on track to hit our adjusted gross margin goal of 55% by the time we exit 2015. Given the volatility of the dollar a year ago, it is hard to predict what the exchange rate will be in the fourth quarter. So there is some potential that the combination of mix and FX could bring us slightly below this target. However, we continue to pursue mitigation opportunities to reduce any potential impact. As [indiscernible] we expect it to be minimal and would still show a very significant improvement in our adjusted gross margin on a year-over-year basis. Furthermore, it would have little impact on our 2016 gross margin or our longer term gross margin outlook. We will continue to keep you informed of our operational progress and as a reminder, we will be sharing more details about our longer gross margin expansion plans at are upcoming analyst meeting. For now though, I’d like to remind everyone that our current gross margin improvement initiatives do not represent the total opportunity we have to improve our gross and operating margins and we’re continuing to evaluate additional future opportunities for margin expansion. In fact, right in the first quarter, we took additional steps to reduce our operating expense cost basis, which include the realignment of certain of our businesses and a consolidation of certain additional facilities in North America. As we said in our last earnings conference call in February during 2015, we expect to accelerate operating margin gains through aggressive SG&A cost control. These productivity initiatives, which were contemplated in our original 2015 adjusted EPS guidance range, will provide meaningful flow through to operating margin, while providing us with an ability to fund strategic investments such as Vidacare marketing efforts or operating infrastructure required to execute our distributor to direct strategy. As a result of these new initiatives, the company estimates that we’ll incur pre-tax charges of between $6 million to $7 million relating to these programs, which primarily consist of employee termination benefits and contract termination costs. These latest initiatives are expected to achieve an annualized savings of approximately $12 million to $14 million once they have been fully implemented. We currently anticipate that we’ll begin to see some savings towards the later part of 2015 related to these plans with the majority of the savings being generated in 2016. Finally, I would like to close my prepared remarks by saying that we are reaffirming our previously provided financial guidance for 2015, which called for constant currency revenue growth of between 4% and 6% and adjusted earnings per share between $6.10 and $6.35 per share. As you probably remember, when we gave our initial guidance for 2015, we were concerned about the potential volatility around currency. We were intentionally conservative around our constant currency revenue guidance, anticipating that an upside in revenue could minimize some of the downside from currency. This is precisely what we saw in the first quarter and although the currency decline was greater than our initial expectations, we are in part able to compensate for that fall off with better than expected constant currency revenue growth. That completes my prepared remarks, and I would like to now introduce and turn the call over to Liam. Liam, who has been with the company for six years is an ideal leader for the newly created position of Chief Operating Officer. He’s been instrumental in much of the success that Teleflex has had over the past several years. And prior to his latest appointment, he previously held positions at Teleflex which included Executive Vice President and President of the Americas, as well as Executive Vice President and President of the International Operations. In his new role, Liam will be responsible for the global commercial strategy of the company as Head of the Americas, Asia Pacific, Europe, Middle East and Africa regions. And his primary focus will be managing the company’s sales, marketing and research and development functions and identifying opportunities for cross business investments and collaboration in these other areas. Liam, congratulations on the significant and very well-deserved promotion.
Liam Kelly:
Thank you, Benson, and good morning, everyone. It is my pleasure to be speaking with you this morning. Like Benson, I too am encouraged by Teleflex’s first quarter results, as well as the multi-year opportunity that lies ahead of us to drive consistent, above-market constant currency revenue growth. We have the opportunity to leverage our business to expect significant operating margin expansion and adjusted earnings per share. With that said, let’s turn to a more detailed review of our first quarter product and geographic revenue results. For the consolidated company, first quarter 2015 constant currency revenue grew 5.2%. This revenue growth was broad-based both in terms of product lines and geographic regions. Sales volumes improved and contributed approximately 256 basis points of revenue growth. This growth was driven by core growth of 124 basis points and Vidacare growth of 132 basis points. And while it may appear at [indiscernible] plants as a percentage of revenue growth attributed to core product volume may have been lower than what we expected when we provided our initial financial outlook for 2015, it is important to understand that the company had one less shipping day in the first quarter of 2015 as compared to the first quarter of 2014. This impacted our constant currency revenue growth by approximately 1% and particularly impacted the sales growth we attributed to core products. If you were to normalize our first quarter results for the impact of one less shipping day, the revenue growth stemming from core products would have been above the upper end of our original full-year revenue growth guidance expectations. Turning to Vidacare. During the first quarter, the performance of these product lines exceeded our expectations and contributed approximately 132 basis points towards our overall revenue growth rates. From a regional perspective, Vidacare growth was strongest in North American hospital market with sales increasing approximately 31%. Recent investments we have made in international markets are starting to payoff. And during the first quarter, Vidacare generated approximately 25% of its overall revenue from overseas markets. It is our belief that we’ve a significant opportunity to further penetrate both the U.S. and the international markets with the Vidacare product line and we intended to continue to invest behind this high growth, high margin opportunity. Moving to new product introductions, during the first quarter new products contributed approximately 126 basis points of revenue growth. This represents the highest level of revenue growth attributed to new product introductions since the third quarter of 2013 and further supports our belief that our R&D product development efforts are paying dividends. New product growth this quarter was led by sales of our European EASK CVC kits, surgical product introduction stemming from our partnership with a large robotics provider and sales of our Rusch Disposable LED Laryngoscope. Turning to pricing, during the first quarter the average selling price of our core products were within our full year guidance range assumption and contributed approximately 19 basis points of growth. These price increases resulted from improvements we were able to generate in our North American surgical business. And this takes me to the last component of quarterly revenue growth are the contribution we received from distributor to direct conversions and the acquisition of Mini-Lap Technologies. Revenue growth form these items totaled approximately 118 basis points almost primarily due to the impact of distributor conversion. The performance in these areas were in line with our initial expectations for the first quarter. It is important to understand that as we progress through the year, we expect the contribution of these items to accelerate. Next I would like to provide some additional color surrounding our segment and product related constant currency revenue growth drivers. Vascular, North America first quarter revenue increased 9.2% to $67.9 million. The increase in vascular revenue was largely due to higher sales of Vidacare and Central Venous Catheters. Anesthesia/Respiratory North America first quarter revenue increased 1.6% to $55.4 million. The growth of this quarter was largely the result of increased sales of our LMA MAD Nasal atomization product. The LMA MAD Nasal device is a needle free intranasal drug delivery product that provides an alternative drug delivery method for use with drugs approved for Nasal delivery. This product is one that we plan to highlight at our upcoming Analyst Day meeting on May 21. Turning to our surgical North America business, its revenue increased 9.4% to $38.1 million. The increase in surgical revenue was due to higher sales of ligation clips and access boards. We continue to see a favorable environment for our surgical business with future sales volume from our [indiscernible] . This is as a result of a consent decree on a major competitor in this segment. [Indiscernible] is one of our lower margin products, but there is a patient and customer need that must be addressed by Teleflex. We anticipate increased sales volume for the remainder of the year. EMEA exceeded our expectations in the first quarter with revenues up 2.2%, totaling $129.3 million. We continue to see the European market has been stable, with the increase in revenue this quarter, primarily due to higher sales of Vascular Access products including Vidacare. Moving to Asia, our first quarter revenue increased 7% to $48.5 million. This was lower than we expected, driven mainly by timing issues with dealer contracts and ordering pattern. The quarterly increase in Asia revenue was primarily due to go-direct in Japan and the acquisitions of Mayo Healthcare and Human Medics, and as we expected and we provided our original 2015 outlook growth in this part of the world was somewhat offset by lower sales volumes of the existing products in China. We expect this volume to regain momentum towards the latter half of the year. Turning to OEM. Revenue for the first quarter increased 8.2% to $34.7 million. The increase in the OEM revenue was due to the higher sales of existing products in particular catheters. And lastly, our other product revenues for the quarter was up 6%, totaling $55.5 million. The increase in other revenues was largely due to Vidacare sales in EMS and oncology, and the improvement in volumes in our right heart catheter product line. The continued growth of Vidacare and EMS is driven by increased utilization, resulting from investments made in quarter four last year cadaver labs and training. We see the more rapid growth in the hospital sector, due to increased convergence as a very positive sign. Shifting gears for a moment, the first quarter of 2015 saw a continuation of the company’s track record and expanding contractual agreements with our GPO and IDN partners. And during this past quarter, Teleflex won a total of 10 agreements. These awards were wide ranging, including CVC and Laryngoscope awards with HPG, endomechanical suture and trocars awards with Premier, and fluid management respiratory therapy and endotracheal tube awards with [indiscernible] . We continue to view our ability to simultaneously gain share and modestly raise prices in the United States as a very good sign. Next, I would like to update you on some recent new product introductions and regulatory approvals. The first of which is our Triple-Lumen Arrow PICC with Chlorag+ard technology. The cornerstone of our overall vascular access strategy surrounds, how we can improve upon vascular complications and has lower cost per hospital. And in the late February, we announced the launch of a device that will help us achieve that goal. These pressure injectable PICCs are the world’s first FDA-cleared central venous catheters to significantly reduce the risk of central line-associated bloodstream infections and PICC-related vessel thrombosis, compared to traditional uncoated catheters. And with this product launch, it completes our portfolio of single, double and triple-lumen catheters and related kits. We’re excited about this product launch as it is an example of how Teleflex is not simply introducing individual products, but instead, building strategic business units designed to reduce complications and costs for healthcare providers. The next product I would like to draw your attention to is the Rusch Airtraq Video Laryngoscope System. Similar to the strategy we are taking in our vascular business, the strategy in our anesthesia business is to transform from an individual product-centric approach to an outcome driven business model. The launch of the Rusch Airtraq Video Laryngoscope System is another example of Teleflex, executing upon this strategy. We’re already a market leader in the laryngoscope space and the addition of that video rounds out our portfolio offering to this key customer base. This device provides improved visibility for intubating patients, where overcoming challenging patient positioning and difficult airways is vital. This system revised an affordable per use option with single use disposal blades. The additional of a snap-on video camera provides a rotating screen, recording capability and multiple display options. And lastly, before I touch on two small acquisitions, that we recently closed, I would like to you about our Percuvance Percutaneous Surgical System. The Percuvance System is intended to manipulate tissue by introducing a variety of instrument configurations into the abdominal cavity. Percuvance requires a smaller incision site than traditional laparoscopic surgery. It offers a reusable handle that is compatible with interchangeable instrument tips, and unlike other laparoscopic devices, the Percuvance System affords a percutaneous insertion into the patient without the use of a trocar. This recently cleared FDA device was percutaneously inserted into a human for the first time in a procedure at the Cleveland Clinic in mid-March. These first human procedures are a major milestone in our strategy of developing platform technologies that will broaden our portfolio with products that provide clinical efficacy, enhance patient experience and lower the overall cost of care. We believe that this system has the potential to transform the standard of care from traditional laparoscopic surgery to percutaneous surgery and will be another product that we will highlight at our upcoming Analyst Day. Next, I would like to briefly discuss two small acquisitions that were recently completed. The first was the acquisition of 00:22:44 [indiscernible] , a private company established in 1993, [indiscernible] offers a broad range of disposable and reusable laryngoscope devices. Teleflex had been [indiscernible] primary laryngoscope distributor in the United States. And this acquisition positions Teleflex to [ph] de-layered supply chain in the U.S. market and strengthens our international competitive position. This all cash acquisition is expected to be modestly accretive to revenue and earnings in 2015. And lastly, I would like to touch on another acquisition that was completed shortly after quarter end that being TrinTris Medical. Another private company, TrinTris Medical was acquired in late March. TrinTris is an original equipment manufacturer of balloon and catheter products. The rationale behind this acquisition was that its balloon forming and attaching capability complements our existing catheter business and fill the product gaps that we had within our portfolio. This too was an all cash acquisition and it is also expected to be modestly accretive to revenue and earnings in 2015. That completes my prepared remarks. I would like to thank everyone for the opportunity to speak with you this morning, and I look forward to meeting and speaking with members of the investment community in the months and years to come. With that, I would now like to turn the call over to Tom. Tom?
Thomas Powell:
Thanks, Liam and good morning, everyone. Given Liam’s discussion of the company’s revenue growth drivers, I will begin my prepared remarks at a gross profit line. For the first quarter, adjusted gross profit was $224.8 million versus $221.2 million in the prior year quarter. Adjusted gross margin increased 190 basis points to 52.3%. The increase in adjusted gross margin was primarily due to improvements in operational efficiency, distributor conversions, modest level of net product pricing and favorable product mix, including robust sales of Vidacare. These improvements were partially offset by the unfavorable impact of foreign currency exchange rates that reduced gross margin by approximately 30 basis points. For the first quarter, adjusted operating profit was $87.8 million, an increase of 6.2% versus the prior year quarter. Adjusted operating margin increased 160 basis points to 20.5% with the increase being largely attributed to the improvement in gross margin. During the quarter, we held adjusted SG&A and R&D spending to below 2014 levels. However, this spending level did not materialize into additional operating margin leverage, as further gains were inhibited by the fact that foreign currency impacts also reduced reported revenue growth to minus 2.1%. Moving next to our adjusted tax rate. For the first quarter of 2015, the adjusted tax rate was 22.3%, a reduction of 220 basis points as compared to the prior year period. The year-over-year reduction is primarily due to tax planning actions that were executed mid-last year. On the bottom line first quarter adjusted earnings per share totaled $1.30 or an increase of 6.6%. For the quarter we estimate that foreign currency reduced adjusted earnings per share by $0.09. If we exclude the currency impact earnings per share growth would have been 13.9%. Turning to the balance sheet in cash flow highlights. During the quarter, cash provided by operations was approximately $42 million or an increase of 1% versus the prior year. The first quarter growth in cash flow lagged adjusted earnings growth largely due to a tough prior year comparable stemming from a large receivable collection from the Spanish Government in the first quarter of 2014. We continue to project full-year 2015 cash flow from operations to both remain on target to exceed $300 million and to achieve growth in the level consistent with adjusted earnings growth. From a balance sheet perspective, cash on hand totaled $309 million with $29 million in the United States. Leverage at for our credit facility definition stood at approximately 2.66 times. And finally before I move on to discuss our 2015 outlook, I will address actions being taken to further optimize our capital structure. This morning we issued a notice of redemption to holders of our 2019 senior subordinated notes at their interest at a rate of 6% and 7.8%. The date of the redemption is set to coincide with the first call date of the notes or June 1, and the redemption price equals 103.438% of the principal amount was accrued in on paid interest. We intend to fund the redemption that notes who borrowing under our revolving credit facility. This transaction is net present value positive and as adjusted earnings per share accretive. Leverage for credit facility definitions will be not be effective. Our objective in executing this transaction is to take advantage of lower cost financing options, while maintaining a balance of fixed versus floating rate debt. Our pro forma mix of debt post transaction is expected to be approximately 57% fix and 43% floating rate. Following the transaction, we’ll have an excess of $400 million of undrawn capacity on a revolving credit facility. During our year-end call, we had discussed that foreign currency headwinds had intensified, but that we were pursuing a number of actions to mitigate the currency impact. This refinancing was one of the potential actions, and we’re pleased to be able to report that this plan is now being realized. Next, I’ll provide an update to 2015 financial guidance. Today, we’re affirming our previously provided 2015 financial outlook. For 2015, we continue to expect constant currency revenue growth of between 4% and 6%. Additionally, we expect 2015, adjusted gross margin to increase 150 basis points to 250 basis points and to be in a range between 53% and 54% for the year. And as previously discussed, we anticipate that we will exit 2015 with an adjusted gross margin of 55%. From an operation standpoint, we’re executing well against the planned actions required to achieve that 55% fourth quarter goal, but could be challenged, should currency headwinds cause additional margin pressures. The projected gross margin increase is largely due to manufacturing cost improvement and productivity initiatives, positive mix including continued mix benefits from Vidacare plus pricing and margin gains stemming from distributor to direct conversions and recently completed acquisitions. Headwinds from currency rates have increased since we originally provided 2015, financial guidance back in February. We initially expected that FX would create a 50 basis point headwind to full year gross margins, we now project the impact to be approximately 65 basis points. Moving on to adjusted operating margin and earnings per share. For full year 2015, we continue to expect adjusted operating margin to increase by approximately 200 basis points to 250 basis points to a range of 22% to 22.5%. We have made operating margin flow through, a 2015 priority, and have taken steps to drive SG&A productivity while at the same time, making certain to also maintain funding for strategic investments and high margin, high growth opportunities. In addition to the recent restructuring initiatives, discussed earlier on the call, operating margins will also benefit from operating and expense efficiencies came through December 2014 reorganization of our North American anesthesia and respiratory sale forces, plus the 2014 restructuring of our European finance and marketing organizations. Similar to gross margin, the gains we expect to generate at the operating margin line will be negatively impacted by foreign exchange. We estimate that the full year 2015 operating margin could be approximately 100 basis points higher, if we’re not for foreign exchange headwinds. Moving on to taxes and interest expense. We continue to expect our full year adjusted tax rate to fall within the range of 20% to 21%, and adjusted net interest expense is now projected to be approximately $51 million for the full year of 2015. Turning to shares outstanding and FX rate assumptions. Given the first quarter appreciation in Teleflex’s stock price, we’re now assuming an additional dilution from the warrants. This additional dilution is projected to reduce full-year adjusted earnings per share by approximately $0.07 more than we initially planned. The adjusted weighted average share count for full-year 2015 is now projected to be approximately 45 million shares. Given the recent trends and expectations for currency, we’ve adjusted the euro to U.S. dollar exchange rate to be a $1.08 for the balance of 2015 versus our previous assumption of $1.13. The euro represents our largest single currency exposure with approximately one third of Teleflex’s revenue being transacted in this currency. As covered in our prior earnings call, we estimate that each $0.05 move in U.S. dollar, euro exchange rate will have a translation impact on adjusted earnings per share of approximately $0.20. Recognizing the significance of the euro exchange rate for our business, we have taken actions to counter the recent move in the euro and we’ll continue to look for additional counterbalancing actions. However, we’re also striking appropriate balance with the need to continue to invest for the future. So far, we have been able to offset one for one, the greater headwinds from both currency exchange rates and higher than anticipated warrant dilution, with an equivalent level of positive earning benefit for both Q1 results and projected operating performance, in order to maintain our 2015 adjusted earnings per share guidance range of $6.10 per share to $6.35 per share. In closing, from an operating standpoint, we have started the year on sound footing. First quarter volume trends are encouraging especially in North America. Revenue from new products exceeded expectations and the early read on new – and on a new surgical platform Percuvance is quite encouraging. Vidacare continues to perform very well and recent distributor conversions in Asia are driving volume and margin gains. Our footprint consolidation initiative is on track and we have now completed to move up to smaller California sites to their Mexico and check receiving locations. We’ve also briefly initiated a restructuring of select operating segments back when completed [indiscernible] 70-basis point improvement to operating margin. For the quarter, we achieved 190-basis point improvement in adjusted gross margins and 160-basis point improvement in adjusted operating margin. Cash flow generation is on track and our leverage levels have been reduced to under 2.7 times. Of an operating standpoint, we’re encouraged by the strength of our 2015 results to-date and our ability to offset the additional Q1 currency headwinds. That concludes my prepared remarks and I’ll now turn the call back to the operator for questions. Operator?
Operator:
[Operator Instructions] First question comes from the line of Larry Keusch of Raymond James. Please proceed.
Larry Keusch:
Hi, good morning everyone.
Benson Smith:
Good morning, Larry.
Thomas Powell:
Good morning, Larry.
Larry Keusch:
Two questions for you guys, first Benson maybe you can expand a little bit on what you’re seeing relative to the comments that have been made on the firming of the environment in North America. I’m just curious, so where you’re seeing the strength, sort of what product lines seem to be experiencing the improvements, et cetera?
Benson Smith:
So our – we certainly saw a considerable strength in our surgical business in North America that was up 9%. We did not see the same kind of strength in the respiratory therapy business for example, which was very low in the single digits, vascular was up 9.1% I think also. So it’s targeted improvement. I think our estimate would be it has more to do with increasing levels of acuity as opposed to just outright admissions given the strength in some of those particular product lines, but not in respiratory therapy which is much more associated with general admissions and that’s the general sense we’re getting from the providers that we talk to.
Larry Keusch:
Okay, perfect. And then Tom for you, just, I want to just come back to the gross margin outlook for the end of the year and the 55% exiting. First I want to just make sure I understand is the comment around the potential to miss that solely due to FX?
Thomas Powell:
Well, the way we look at it Larry is that we have a number of planned actions that are against to that target. And as we discussed in the prepared remarks, we’re executing very well against that. And we had a good first quarter performance. So as we look to the fourth quarter, we are still tracking towards those plans that we put in place and we feel good about those. We are raising the spectra that FX continues to be something that’s a bit uncertain and unpredictable and it will have a margin impact for us. And so we’re just raising that as a potential issue now. From an operating standpoint, we feel good about how we’re moving against that plan and look forward to executing the rest of the initiatives as the year progresses.
Larry Keusch:
There is certainly operational items yet to be achieved and as Tom said, where we feel quite good about where we are in the process, it’s just really hard right now Larry to predict what the dollar-euro exchange rate is going to be in the fourth quarter it could be parity, it could be $1.5 and there is an impact on what our fourth quarter gross margin is going to be that is one of those items that’s largely out of our control.
Benson Smith:
There are some other issues with mix that could have some balance, we have mentioned the fact that the single biggest competitor in the chest drainage area has some regulatory issues, we are doing our best to provide an alternative product to our customers here in the U.S. and actually we’re going to be selling every single one of those that we can make from a responsibility standpoint to our customers, it’s going to be good for revenue, it’s going to be good for EPS, it’s one of our lower gross margin products, so it can have a small drag on our gross margins. But I think from an operational standpoint of view, we’re quite satisfied that we’re right on track to where we need to be.
Larry Keusch:
Okay. And then last one on this, and then I’ll drop. You guys did mention that if you were to miss that target, it would be a small miss, but would you care to put some brackets around that just to help us?
Benson Smith:
Yeah, I think the best thing we can do Larry is, is on a quarter-by-quarter basis, keep you up – keep you informed in terms of how we’re doing operationally, what our current currency expectations are where at $1.08, we expect we’re going to hit that 55% number.
Larry Keusch:
Okay, great. Thanks very much.
Operator:
The next question comes from the line of David Lewis of Morgan Stanley. Please proceed.
John Demchak:
Hi, good morning, this is actually, John Demchak in for David.
Benson Smith:
Good morning, John.
Thomas Powell:
Good morning, John.
John Demchak:
So first off, I wanted to say congratulations to Liam on his new role. And I had a kind of a question about that, because I think that a lot of investors may look. This is kind of a start of a possible leadership transition. So Benson, I was wondering if you can maybe comment on this and if there is any truth to that thought. And then also like why is now the right time to be adding the COO role for the company?
Benson Smith:
Yeah, so. I appreciate the question despite my useful appearance and balance energy. I do get asked about my potential retirement plans from time-to-time. I just think it’s important for every company to have a some kind of a transition plan. It takes a while to get familiar with all the issues that the CEO might have to grab away. So it’s not an overnight plan at all. We’re – I would say I’m quite pleased with the general level of promotable candidates we have within our senior leadership team. And from a structure standpoint of view, really for the last couple of years, I’ve been doing the CEO role and a good part of the Chief Operating Officer role. So it’s I think we’ve reached a point in our organization development, where quite frankly we need some more attention on [indiscernible] services. This is certainly mainly factored at or move that we’re trying to make here. But I’m quite Liam Kelly asked me when I’m leaving also and I won’t give him a definite timetable.
John Demchak:
Thank you for that. And just a quick follow up for Tom on EPS guidance holding constant. So it looks like organic trends in the business may actually be going a little better as given the reaffirmed guidance following a couple of headwinds from I guess share dilution and also additional FX pressure, which I guess combined seem to total somewhere about – sorry seem to total somewhere about $0.10. And I was I guess a little less clear on the offset, some of that clearly looks like it’s coming from better Vidacare performance, I think that you guys said that it was over a 100 basis points to revenue growth versus about 50 basis points that were estimated for the year, I think originally. So I was just wondering if you could may be cross walk me to kind of how EPS state constant given those headwinds.
Thomas Powell:
Sure, sure. Well, we – just to kind of make sure that we clarify the headwinds as we updated our guidance on foreign exchange and share dilution. We come up with $0.12 more I guess headwinds then we initially had expected $0.05 from foreign exchange, $0.07 from share dilution. And then we look to what’s going to offset that we have a number of factors that we’re looking at. One is, first of all, Q1 came in a little bit stronger on our earnings and we had expected so there is a couple of pennies there. We also have added couple of smaller acquisitions, which collectively contribute a little bit less than $0.05. And then we also have the refinancing debt, which contributes $0.08 to $0.10 for the year. So collectively those benefits are in the $0.15 perhaps $0.17 range offsetting the $0.12 of additional headwinds. So we feel pretty good that we’re at $0.03 to $0.05 on the positive side from where we started given the offsets.
John Demchak:
Thank you very much.
Operator:
The next question comes from the line of Matt Taylor of Barclays. Please proceed.
Yong Lee:
Hi guys. This is Yong Lee for Matt Taylor. Thanks for taking our questions. I guess, just to start off, I’m wondering if you can just provide some additional details on the weakness in Asia more specifically in China and what are you seeing in the market that gives you confidence that volumes can prove in the back half of the year?
Benson Smith:
So towards the – well, last year we also saw some weakness in China, that was largely due to the sale of our intra-aortic balloon pumps which is a capital equipment of sale. We are seeing that recover. And so that’s certainly a move in the positive direction. During the first quarter of every year, we go through a process where we essentially do renegotiations with actually relatively a large number of distributors and that process is a little slower than what we thought. So we are – we did not see the order pattern from those distributors come in the first quarter, our belief is that that is simply a timing issue and as those agreements are being executed, we’re getting filling orders. So I’m not sure that’s the case with other peoples experience in China right now. In our case, it’s somewhat idiosyncratic situation and we think we’ve got pretty darn good insight into it. And therefore, have a – I would say a pretty good level of confidence that we’re going to see that rebound.
Yong Lee:
All right. Great. And also you made two acquisitions in the quarter. Can you just remind us about your capital allocation priorities and also how is the M&A pipeline working for you?
Benson Smith:
So we continued to be – we continued to remain committed to our essential acquisition strategy which includes we call them Vidacare LMA size acquisitions late-stage technology acquisitions, dealer direct acquisitions, and I would add to that these [indiscernible] acquisition is really is an example of a vertical integration opportunity, where we had been buying a product from them and it is more of a gross margin enhancement opportunity than necessarily a direct revenue enhancement. We continue to remain committed to that and believe that under the current circumstances that’s where the priority is. I would say just turning to our attention to the Vidacare LMA side of the acquisition, we continue to believe that there is a good pipeline availability of companies out there for us. Bear in mind we have the financial flexibility to do one of these about every 18 months. So there doesn’t need to be – there doesn’t need to be a large number of them out there for us to be able to meet our goal. That being said, we’re pretty darn picky about what makes a good acquisition for us. And our general sense is we get rewarded to doing acquisitions as we get rewarded to doing really good acquisitions. So we are – we continue to maintain a – I would say a lot of discipline around what we’re willing to buy.
Yong Lee:
Okay. Great. Thank you.
Operator:
The next question comes from the line of Dave Turkaly of JMP Securities. Please proceed.
David Turkaly:
Thanks. And just a follow-up on the comments the North American strength. I know you had some issues last year. I was just curious form a head count level of the sales forces particularly in Vascular and Surgical, did they increase? And then this new restructuring initiatives, I think you talked about some termination benefits and maybe some productivity increases. And I was just wondering if you could give us an example of exactly what you’re doing to kind of increase the productivity if it is on loaded head count.
Benson Smith:
So we – there were some modest head count increases in our Vascular business as a result of the Vidacare acquisition. Surgery, really has remained largely constant at this point, although it’s a targeted area for some modest expansion, as we roll out the Percuvance product line. The adjustments that we’ve made in terms of cost control really come more at the expense that eliminating some smaller divisional and managerial head count versus sales head count. So we haven’t really change the head count we’ve just reapportioned it. And we think that is actually better to have a smaller sales force exclusively focusing in on respiratory the therapy business that’s a very GPO oriented IDN oriented sale. And have that remaining sales force in the anesthesia product lines really just focused on – on their products and their co-point. And so far I think the responsive has been quite favorable. So we have not other than the – other than small addition that came from Vidacare changed our head count. I think David it’s as much due to having kind of a more exciting product lines to sell. And we’re – that helps sales commissions, that helps attract a better group accounted sales people to the organization and all those things are paying off. And I would say for the last several years, we’ve been focusing a lot on sales force effecting this.
David Turkaly:
Great. And then on the distributed direct opportunities, you’ve done several. I was just wondering if you could just give us a ballpark figure of how many sort of sizable ones are out there for you, there are still 10 of these are out there are there just ballpark, how many of these things could we possible see kind of come internal over the next couple of years?
Benson Smith:
And so it’s probably, so they’re are very different size and very different numbers. I think the best answer I can give to that question. We’ve generated around 100 basis points of improvement in terms of our numbers and over the past couple of years as an average. And we certainly have a free clear line of site over the next couple of years. And I think what you’ve seen in the past couple of years as an average is what you’re going to see over the next couple of years.
David Turkaly:
Thanks a lot.
Operator:
The next question comes from the line of Matt Mishan of KeyBanc. Please proceed.
Matthew Mishan:
Great. Thanks for taking my question.
Benson Smith:
Hi, good morning.
Matthew Mishan:
I’m not sure – yeah I’m not sure if I missed it or not, what was surgical Mini-Lap?
Benson Smith:
Mini-Lap, was about 30 basis points of surgery. So with the very small contributions to their...
Thomas Powell:
700,000.
Benson Smith:
700,000, so 30 basis points of that 9% increase.
Matthew Mishan:
All right, great. And on Europe, it came in at like 2.2%, do you think you had some pull-forward in the fourth quarter from this quarter?
Benson Smith:
No.
Matthew Mishan:
Okay. And lastly, on Percuvance, and I don’t want to steal anyone’s thunders from the Analyst Day. But have you guys thought about what this product can do not necessarily this year, but in 2016, 2017 as far as revenue growth goes?
Benson Smith:
So the short answer is yes, we thought about it a lot, there is a wide range in terms of what the performance of this product line can be. Right now, we’re in fairly intensive clinical used opportunities in leading institutions around the United States and in Europe and getting an understanding from the early highly experienced laparoscopic surgeons where they see this most applicable and to try and understand what percentage of the traditional laparoscopic procedure rate it’s going to be able to I think be able to encroach into. At this point, the feedback we’re getting from the physicians that are using this is quite positive. And again, we’ll have more information to be able to share with you at the Analyst Day. We’ll have one of the leading surgeons in the U.S. that’s working with us on this to give you his view points.
Matthew Mishan:
All right. Thank you, Benson.
Operator:
The next question comes from the line of Jason Wittes of Brean. Please proceed.
Jason Wittes:
Hi. Thanks for taking the question. Wanted to focus a little bit more on Vidacare. First off, is it helping with pull through with your PICC and CVC business as well? And as part of that question, could you just give us the growth of vascular ex-Vidacare?
Benson Smith:
Yeah. So just answering the question about Vidacare as a pull through item. So I think the short answer is yes, I mean it’s an exciting product to sell. We made really good inroads into the hospital segment in the first quarter. The growth within that unit was right at 31%. It was one of the key reasons that we purchased Vidacare was we felt we could do a really good job with that in hospital customer and beyond the emergency room in the hospital getting right down into their crash car situation. I don’t know that we have a completely exact number. But I would say it’s somewhere between 6.5% and 7% of Vascular growth without Vidacare. So it’s still pretty strong growth even with that accepted. But I will tell you that this growth isn’t happening by accident, it’s taking sales time and sales energy to be able to move it into that – into that segment. And every time we sell a Vidacare unit, it’s the highest gross margin product we have. So we’re certainly not discouraging them from spending a lot of time on it.
Thomas Powell:
Yeah, Jason. Benson is right. It was – for the first quarter Vascular North America revenue grew 6.9% excluding Vidacare sales.
Jason Wittes:
Okay. And do you have a sense of where CVCs and PICC lines? If you give us kind of a sense of where those are growing is about that rate or?
Benson Smith:
Yeah. So CVCs grew around that rate – around that 6.6% constant currency rate for Vascular North America and PICCs were a little bit lower than that in the Vascular North America area although I would say globally they grew about 18%.
Jason Wittes:
Okay. That’s fair. And the consent decree issue with your competitor, obviously you probably have much visibility on how long that might last although it’s usually pretty prolonged. Do you guys sense is that – I assume that’s boosting your surgical numbers, is that part of the reason why you’re...?
Benson Smith:
Not yet. Not yet. Those agreements are really didn’t have any significant impact on our first quarter results where is – what – because we’re in a position to supply from a demand standpoint, we have been quite aggressively ramping up those and we are – just doing our best as we really to respond to a critical situation here. But we are certainly leaning in favor of those institutions and groups that are willing to give us a long-term contract with the product. Particularly given the uncertainty of when the issue may be resolved.
Jason Wittes:
Okay. That’s helpful. And then you mentioned, I think you have about $400 million of borrowing capacity, I may have misheard that.
Benson Smith:
Correct, $400 million.
Thomas Powell:
Yeah.
Jason Wittes:
And so is that about the size, the potential size, could you probably see we use that all for acquisitions or is that – or if I think about you generally have a pretty tight constrains in terms of what the range is in terms of how much leverage you’re willing to take on for an acquisition. Can you give us a sense of where that stand at the moment?
Benson Smith:
Yeah. So we could go up to that size of borrowing and still be within our comfort range in terms of total leverage. So that’s what readily available on our revolver, we’ve got opportunities to be able to expand the revolver as well by another $250 million if we were to choose that option, that would take some time to get in place, but not too long.
Jason Wittes:
Okay. That’s helpful. I’ll jump back in queue. Thanks a lot.
Operator:
The next question comes from the line of Anthony Petrone of Jefferies. Please go ahead.
Anthony Petrone:
Thanks, good morning. And then congratulations, Liam. Maybe a question on foreign currency, we’re seeing this for some of our other companies. If I look at the EMEA performance and APAC performance even on a constant currency basis it seems to have slowed sequentially. So I guess my question is, do you see a slowdown in demand for your U.S. manufactured goods and products from overseas customers just as their purchasing power has eroded? And then a couple of follow-ups.
Benson Smith:
Yes. So the short answer to that is, no, we don’t change our pricing in OUS markets based on currency for the most part if we take the hit as opposed to our goods becoming more expensive over there. Europe actually exceeded our expectations, I think that there continues to be a fair amount of economic uncertainty in Europe. So we look at the stability as being good. Our revenue in Japan was really quite good for the quarter, Australia is now since our Mayo acquisition it’s a bigger part of our Asia business and they’re – they tend to be a slower growing developed market. I think for us, our slower performance in Asia was quite limited to China and quite limited to a timing issue I think. So I don’t know that we’re represented of both what’s going on with other countries.
Anthony Petrone:
It’s helpful. And then one for Tom, just housekeeping here. Can you just run through the annual savings in interest expense following the senior subordinated tender ones that’s completed, where that will trend. And then we’ll ask follow-up on Percuvance?
Thomas Powell:
Okay. So on the interest expense, we’re assuming that we’re going to save about $0.08 to $0.10 from an adjusted EPS impact. Interest expense will go down to about $51 million for the year. And that’s...
Benson Smith:
That basis...
Anthony Petrone:
Got it.
Benson Smith:
On an adjusted basis.
Thomas Powell:
Yeah, on a adjusted basis.
Anthony Petrone:
On an adjusted basis over 12 months, right. So they’re not – you won’t?
Benson Smith:
It will go down $251 million for the year, on an adjusted basis.
Anthony Petrone:
Got it.
Benson Smith:
So…
Thomas Powell:
Yeah.
Anthony Petrone:
Got it. And then on the last one from me on Percuvance, maybe just a recap in the early days here how that stacks up from a pricing standpoint versus traditional lab instruments. And then you mentioned in the release a few weeks ago, that you’re really looking at a wider launch in 2016, why the time between now and the wider launch and just an update there that would be helpful? Thanks.
Benson Smith:
So the – the, so we’re still obviously trying to get the best deal on where they should be priced. There is an inherent savings just from one to another from a hospital because they don’t have to use trocars in the procedure. The time it takes to finish up the procedure is shortened, so in a busy overall, that’s another issue. The potential for our complications is reduced which is also a cost savings to the hospital. Why are we doing a gradual launch? This is kind of a – I would characterize it as a major opportunity for Teleflex. My past experience is, is that you learn a lot in the first couple of months in terms of actual user experience, in terms of what the benefits are to highlight, what the training, actual training might be to be able to get this introduced. You also have a better understanding in terms of the best initial procedures to target. And all that in my past experience leads to a much better to launch when you have a little bit of that ground work behind you. So this is a big opportunity. Our sense is we want to do this right and make sure we’re deploying those resources in the best way possible.
Operator:
Okay. This is the operator. As our communication link has gone down between [indiscernible] and other speakers. There is one more question, would you like to take that?
Benson Smith:
Yes, we would.
Operator:
Certainly. So the final question comes from Richard Newitter of Leerink Partners. Your line is open. Please go ahead.
Ravi Misra:
Hi, good morning. It’s Ravi in for Rich. Can you hear me?
Benson Smith:
Yeah. Go ahead.
Thomas Powell:
Yeah.
Ravi Misra:
Great, thanks. So, a couple of questions and one housekeeping question.. How many on the gross margin, just curious in terms of some of these new PICC introductions, how they affect gross margins versus the corporate average? And then on the Truphatek acquisition, trying to figure out how do these types of vertical integration plays – play into your gross margin expansion strategy. I mean are they necessary or are they sort of a nice to have things as you move towards 55%? And then maybe the last housekeeping question was, Mayo, was that included in the 120 bps of acquisition, because I think there was a month, extra month there?
Benson Smith:
So yes, you’re absolutely correct. It was in January’s numbers, so there was a month there. In terms of your question about are they nice to have or need to have them, they generally came to make small overall contributions to our overall gross margin picture. However, it really changes the profile of some of those products from one that’s not particularly worth of sales person spending a lot of time to, to one that is worth spending a lot of time to, so they are quite helpful from that standpoint. And there is often other benefits associated with that as we were able to take over the manufacturing of the product and some of the benefits take several years actually to get integrated into our system. But it means that as we look forward to the future, this is a product we really want in both the resources and selling time again as opposed to being kind of a marginal product for us. And I forgot you had another question, I forgot what it was.
Ravi Misra:
Yeah, just really quickly. Just curious in terms of the new product introductions like for example the PICC, how is that coming in compared to the corporate average. Is it sort of in line or lower, you expect to trend higher. Any color on that will be appreciated?
Benson Smith:
So most of our footprint consolidation moves affect our vascular product lines. And so the real opportunity for improving any of those product lines really is going to come from the completion of this footprint consolidation. So once completed, yes those would be – those would be an attractive product for us to sell.
Ravi Misra:
Thank you.
Thomas Powell:
And then just a little more color on the impact of distributor M&A et cetera on gross margin. So as we think about the 2015 gross margin expansion, there is only three key areas that are driving that expansion. The first is operations efficiency, I’ll include the footprint consolidation in that that accounts for about half of the gain we’re looking for this year. We also then have collectively a number of acquisitions, smaller M&A, as well as go to [indiscernible] and that includes M&A, Mini Lap [indiscernible] Korea distributor, Japanese distributor, those collectively account for another quarter. And then finally, if we look at mix that’s the third kind of the leg of this stool. Now that’s the final quarter and that would be driven largely from things like Vidacare growth. We’re also looking at winding down our surgical repair business. We got to focus in Latin America and mixed improvements and I think anesthesia/respiratory, whether focusing on some higher margin atomization as well as just go product. So as we think about it, our gross margin drivers are largely being driven out of operations efficiency footprint. But M&A go directs are help and mix help. So it’s coming from a variety of different angles and then the rest it’s kind of a number of pluses and minuses that collectively aren’t that significant, if that helps.
Ravi Misra:
Well, very much. So thanks.
Operator:
I would now like to turn the call over to Jake Elguicze for closing remarks.
Jake Elguicze:
Thanks, Operator, and thanks to everyone that joined us on the call today. This concludes the Teleflex Incorporated, first quarter 2015 earnings conference call.
Operator:
Thank you for your participation in today’s conference. This concludes the presentation. You may now disconnect. Good day.
Executives:
Jake Elguicze - Treasurer & Vice President-Investor Relations Benson F. Smith - Chairman, President & Chief Executive Officer Thomas E. Powell - Chief Financial Officer & Executive Vice President
Analysts:
Lawrence S. Keusch - Raymond James & Associates, Inc. David R. Lewis - Morgan Stanley & Co. LLC David L. Turkaly - JMP Securities LLC Matt C. Taylor - Barclays Capital, Inc. Matthew Mishan - KeyBanc Capital Markets, Inc. Jason H. Wittes - Brean Capital LLC Richard S. Newitter - Leerink Partners LLC Anthony C. Petrone - Jefferies LLC Chris Cooley - Stephens, Inc.
Operator:
Good day, ladies and gentlemen, and welcome to the Quarter Four 2014 Teleflex Incorporated Earnings Conference Call. My name is Summer, and I will be your operator for today. At this time all participants are in listen-only mode. We will conduct a question-and-answer session towards the end of the conference. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Jake Elguicze. Please proceed, sir.
Jake Elguicze - Treasurer & Vice President-Investor Relations:
Good morning, everyone, and welcome to the Teleflex Incorporated fourth quarter 2014 earnings conference call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing 888-286-8010, or for international calls, 617-801-6888, pass code 82954645. Participating on today's call are Benson Smith, Chairman, President and Chief Executive Officer and Thomas Powell, Executive Vice President and Chief Financial Officer. Benson and Tom will make brief prepared remarks and then we'll open up the call to questions. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined on slide four. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors made in our press release today, as well as our filing with the SEC, including our Form 10-K, which can be accessed on our website. With that, I'd like to now turn the call over to Benson.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Thanks, Jake, and good morning, everyone. It's good to be able to speak with you once again. First, let me begin by saying that we are extremely pleased with our results in the fourth quarter and for all of 2014 as well. We hit or exceeded every significant milestone we're targeting with the exception of a slight miss to our gross margin targets in the fourth quarter. This miss was due to some discrete one-time in nature events that will not affect our gross margins in 2015, nor our ability to hit our 55% number by the fourth quarter of 2015. Our strong finish to 2014 leaves us well positioned for excellent revenue growth and P&L leverage in 2015 while currency translations, particularly the euro, will, from an accounting perspective, put pressure on our EPS growth. The strength of our underlying fundamentals will still allow us to deliver meaningful growth in our adjusted EPS. Tom and I will both go into more details during the course of our presentations. Similar to past calls, I will start with an overview of the company's results during our most recent quarter and discuss some highlights. As part of my prepared remarks, I will provide an update as to what we are seeing in terms of end markets, pricing initiatives and new product introductions as well as an update on the Vidacare and Mayo Healthcare acquisitions. I will also touch on two recently completed acquisitions that we're quite excited about. The first being Mini-Lap Technologies, and the second being a distributor acquisition in Korea. Finally, after a brief summary of our full-year accomplishments, I will turn the call over to Tom, and he will go through our quarterly financial results in more detail, as well as provide our 2015 financial guidance. So, with that as a broad overview, let's begin. The fourth quarter of 2014 was another very strong quarter for the company capping off what turned out to be an excellent 2014. Continuing a yearlong trend, as reported revenue and adjusted earnings per share during the final quarter of 2014 once again exceeded our internal expectations. This was quite positive especially when taking into consideration the precipitous decline in foreign currency exchange rates that occurred during the fourth quarter. Despite the greater than anticipated headwind from foreign currency, revenue in the fourth quarter totaled $476 million. This represents an increase of 5.7% versus the prior year, on as reported basis, and 9% versus the prior year, on a constant currency basis. Our better-than-expected revenue in the fourth quarter resulted from the performance of Vidacare, our ability to continue to generate higher revenue from improvements in average selling prices, increased sales of new and existing products, and market share gains. I would like to point out that during the fourth quarter we lapsed the anniversary day of the Vidacare acquisition, which occurred in December of 2013. As such we only had two additional months of Vidacare revenue in the fourth quarter of 2014 as compared to the prior year. This is another example that points to the strength of our underlying base business and gives us confidence regarding our constant currency revenue growth expectations for 2015. Revenue growth in the quarter however was somewhat tampered by a decline in year-over-year sales volume of existing products within our Asian segment. This was something that we signaled as a possibility on our last earnings conference call, and it resulted from the transition of a portion of our Asian business from a distributor to direct model in Japan, as well as inventory reductions from some distributors in China. These declines in China were not across the board and primarily impacted by our capital equipment intra-aortic balloon pump business. As we look forward into 2015, we expect that these issues will be behind us by the second quarter at which point we expect our revenue growth in Asia to return to higher growth levels. Turning to adjusted earnings per share, fourth quarter 2014 adjusted EPS was $1.43. That compares to fourth quarter 2013 adjusted EPS of $1.36. Similar to prior quarters in 2014, the improvement in year-over-year adjusted earnings resulted from higher volumes, continued improvements in average selling prices, and a favorable mix of higher gross margin sales. In addition, we continue to generate increased leverage throughout the income statement from a lower adjusted tax rate when compared to the fourth quarter of 2013. In fact, fourth quarter earnings would have been even higher had it not been for some expenses incurred at the gross margin line that we believe to be nonrecurring in nature. These expenses total approximately $6 million and were primarily associated with the write-off of some inventory and cost related to our facility footprint restructuring initiative. Absent these expenses, adjusted gross margin for the fourth quarter would have been 52.3%. As I said in my opening remarks, we do not expect these items to impact our ability to reach our 55% adjusted gross margin target by the time we exit 2015. In addition, our operating expenses in the fourth quarter were higher than levels seen in prior quarters. We managed our operating expenses tightly all year long and, as you may recall, on our last earnings conference call we said that we plan to make some targeted investments in higher growth opportunities, and we did. We spent more on Vidacare, more on product registrations, and more on the preparation for the launch of our surgical microlaparoscopic product line. As a side note, I would add that we received FDA approval for our microlaparoscopic product line faster than we had anticipated, and now expect the limited market release of the product before the end of the first quarter. These expenses were discrete in nature as opposed to reoccurring. Therefore, we expect our 2015 operating expenses as a percentage of revenue to be approximately 100 basis points lower than what occurred this past quarter. Moving on to some other highlights. Sales volume of core products improved and contributed approximately 185 basis points of revenue growth. This growth was stronger than initially expected and occurred across a wide range of our businesses including our OEM, Surgical and Vascular North America and European segments. We currently view the European markets as stable and the U.S. market as slightly positive, and therefore, attribute the majority of our core sales volume growth to market share gains. Turning to pricing, during the fourth quarter, the average selling prices of our products once again expanded when compared to the prior-year period. This past quarter the improvement in average selling prices of products contributed approximately 151 basis points of revenue growth. These price increases resulted from a combination of distributor-to-direct conversions which added approximately 50 basis points and core product price increases which contributed approximately 100 basis points. From a segment perspective, we once again saw price improvements highest in Asia and as expected, this was primarily due to distributor-to-direct conversions. This was followed by improvements in pricing we were able to generate in our North American and European segments, and most of the price improvements in North America were core product price improvements. And perhaps, it goes without saying, but we continue to be pleased with our ability to drive core product price improvement. Our underlying price improvements were actually better than they appear because we had to offset a decline in average selling prices of some of our OEM product offerings that were agreed to last year. Moving to new product introductions, during the fourth quarter new products contributed approximately 89 basis points of revenue growth. The revenue growth attributed to new product introductions was the highest it has been in the fourth quarter since the fourth quarter of 2013 and further supports our belief that our R&D product development efforts are paying dividends. New product growth this quarter was led by sales of our European EASK CVC Kits, LMA SureSeal and Supreme devices and our Rusch Disposable LED Laryngoscope and surgical product introductions stemming from our partnership with a large robotics provider. Shifting gears for a moment, the fourth quarter of 2014 also saw continued expansion of our contractual agreements between Teleflex and our GPO and IDN partners. And during this past quarter, this resulted in Teleflex winning a total of 14 agreements. I'm happy to say that 11 of these agreements were new, and included product categories like PICC, our VasoNova VPS system and some of our airway management products. These new agreements are playing an important role in our share gains in our core products. We view our ability to simultaneously gain share and raise prices in the U.S. as a very good sign. Next, I would like to update you on Vidacare. Vidacare contributed approximately $23 million of revenue or about 3.5% of Teleflex's constant currency revenue growth. This represents the strongest quarter yet of Vidacare product sales, and if you were to compare these results to the fourth quarter of 2013, it would show that Vidacare's revenue increased approximately 16% on an as-reported basis. On a full year basis, Vidacare product sales totaled approximately $87 million, well above our initial estimate which called for between $68 million to $72 million in sales. We also received some good news from a regulatory perspective as it relates to Vidacare as during the quarter, the OnControl Powered Bone Biopsy system received FDA approval for new pediatric indication for use. We continue to believe that Vidacare product offerings will be an area of significant growth for the company and we intend to invest behind these products accordingly. Next, I'd like to provide you with a brief update on Mayo Healthcare. Similar to Vidacare, this 2014 acquisition also continues to perform quite well. During the fourth quarter, Mayo contributed approximately $7.3 million or 162 basis points of Teleflex's constant currency revenue growth. Approximately 70% of the revenue growth came in the form of additional volume while about 30% came in the form of price increases. I would also like to point out that the integration of Mayo into the Teleflex operating platform continued as during the fourth quarter we migrated Mayo onto our principal SAP platform. This integration occurred as planned. Moving on, I would next like to provide you with an update on our VasoNova VPS System. The VPS, Vascular Positioning System, was an acquisition that Teleflex made back in 2011. The device combines ECG, Doppler ultrasound and software algorithm to accurately place catheter tips in the lower one-third of the SVC, and is cleared to eliminate chest x-ray in adult patients when the Blue Bullseye on the device is achieved. Recently, there was a peer-reviewed article about the VPS System that showed the technology can reduce the improper positioning of central IV catheters. This article was published in the fall of 2014 issue of the Journal of the Association for Vascular Access. The catheter tip positioning project took place at James A. Haley Veterans Hospital in Tampa, Florida, and this article presents the largest cohort at one site of patient results in studies using the VPS System. The article's data showed a 51% reduction in malpositioned catheters when using VPS. We are quite pleased by the results from this study and expect that VPS revenue will accelerate in 2015. Moving on, I would like to tell you about two recent acquisitions that should positively impact our 2015 results. As many of you are already aware, Teleflex has been making investments into the area of micro-laparoscopic access over the past 18 months or so. This started with the acquisition of Eon Surgical in mid-2013 and is continuing with the acquisition of Mini-Lap, which occurred this past December. Mini-Lap is a developer of next-generation minimally invasive surgical instruments. This transaction provides Teleflex a platform technology, additional marketed products that address various segments of the surgery market, as well as pipeline products. It's our belief that Mini-Lap trocar-less entry improves surgical capability and patient outcome and complements Teleflex percutaneous surgery platform. This was an all-cash transaction and is expected to positively contribute towards the company's revenue and adjusted earnings per share in 2015. Finally, before I provide you with a brief summary of our full year 2014 performance, the next acquisition I would like to talk to you about this morning is Human Medics. Consistent with our strategy of becoming increasingly more direct in some key international markets, we acquired Human Medics. Human Medics is a distributor based in Korea that has sold Teleflex surgical and respiratory products since 2004. And similar to the acquisition of Mayo Healthcare, this acquisition establishes a direct sales organization in Korea and allows Teleflex to control the sale and distribution of our products. It creates closer contact with end customers and is expected to expand our revenues and margins. This all-cash transaction closed towards the end of January of 2015 and is also expected to positively impact the company's revenue and adjusted earnings per share in 2015. Finally, let me provide you with a brief summary of our full year 2014 performance. As I said at the beginning of my prepared remarks, 2014 was an excellent year for Teleflex. The company generated constant currency revenue growth of 8.8%, which was at the high end of the guidance range that we provided at our Analyst Day in December of 2013. And we achieved adjusted earnings per share of $5.74. This was well above the initial guidance range we provided and it also exceeded the top end of our most recent guidance range which called for earnings to be between $5.60 and $5.70 per share. Other major accomplishments in 2014 included the successful integration and obtainment of synergies associated with the Vidacare and Mayo Healthcare acquisitions, productivity and efficiency improvements in how we service customers and the announcement of a facility restructuring initiative that remains on track and is expected to drive substantial operating leverage for our business over the next several years. As you will see in a few moments, despite the negative impact coming from foreign exchange, we expect this positive momentum to continue in 2015. We anticipate being able to produce mid-single digit constant currency revenue growth rates, as well as generate significant operating leverage from our businesses including exiting 2015 with an adjusted gross margin of 55%. In addition, we're committed to implementing operational measures to in part mitigate the earnings impact from FX. These initiatives will be targeted in nature as we do not believe it to be prudent to scale back on investment opportunities that might limit our longer-term growth and strategic objectives. That completes my prepared remarks. However, before I turn the call over to Tom, I do want to comment on the impact that FX will have on us in 2015. In most years, currency fluctuations tend to be relatively modest and are not a very big part of the story. That's not true this year. Through prior discussions with investors, we understand that there may be varying degrees of understanding about how currency affects us and varying degrees of importance that investors placed on FX. Currency also affects companies quite differently, and that's one of the reasons it's sometimes hard for investors to have a clear picture of what it means for one company versus another. At Teleflex, currency primarily affects us in a translational way. As a result, we tend to think of currency as an accounting issue more than a true economic issue. From an accounting perspective, when we sell a product in Europe, we had to translate that revenue number in euros back to whatever the currency exchange rate is at the time to the U.S. dollar. We also have to translate our earnings from euros back into dollars, which occurs on paper, but not in actuality. Consequently, the adjustments we make to revenue and EPS for accounting purposes is different than hits we might take in our earnings per share for other reasons such as overspending or lower gross margins. Those aren't really accounting issues, but very real economic issues. On the flipside, it's also true that if we had a big gain in our reported EPS, and most of it came from currency translation, it will also be more of an accounting issue than an economic issue. In our presentation today, we certainly want to be clear about those accounting issues that will affect our P&L. But we also want to be clear about the underlying fundamentals that are more of an indicator of Teleflex's real progress. And while FX will be a headwind to Teleflex's gross margin in 2015 by about 50 basis points, we still think that there are enough other drivers that will allow the company to exit 2015 at 55% adjusted gross margin and achieve our other strategic objectives. I would now like to turn the call over to Tom for him to walk you through the financials. Tom?
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Thanks, Benson, and good morning, everyone. During my prepared remarks, I will start with a review of fourth quarter results, and then briefly review full-year 2014 in the context of how our final results compare with the financial targets that we'd established at the onset of the year. I will then close with our expectation for 2015. Turning now to the quarter. During the fourth quarter, revenues were $476 million, which represents an increase of 9% on a constant currency basis. Approximately 3.5% of constant currency revenue growth was related to Vidacare with the remaining 5.5% of growth coming from an increase in core product volumes, core product price increases, revenues from new product introductions, and distributor-to-direct conversions. Versus the third quarter, we experienced sequential increases in the growth rate of new products, pricing and distributor conversions. Additionally, the strong based volume growth that we realized in the third quarter continued into the fourth quarter which 185 basis point of growth. Vidacare performance continues to exceed expectations. However, as expected, Vidacare's impact on the total fourth quarter growth rate has moderated due to its December 2013 acquisition date and the resulting inclusion of one month of revenue in the prior year comps. Excluding the impact of the Vidacare comp, Q4 marked yet another quarter of improving revenue trends, which will position us well as we start 2015. Turning to gross profit, for the fourth quarter, adjusted gross profit was $243.1 million versus $225.2 million in the prior year quarter. Adjusted gross margin increased 110 basis points to 51.1%. The increase in adjusted gross margin was primarily due to Vidacare and distributor conversions with product pricing also making a positive contribution. Fourth quarter gross margin was below expectations due to approximately $6 million of one-off issues, such as costs associated with our facility footprint restructuring initiative that were not added back when calculating non-GAAP earnings and in isolated product registration code day issue that did not provide sufficient shelf life for product destined for international market and inefficiencies in the start-up of our Australian 3PL warehouse following the consolidation of a number of Australian distributors into a single more efficient network. It had not been for these items, adjusted gross margin for the fourth quarter would have been approximately 52.3%. We also experienced pockets of unfavorable mix that adversely impacted the fourth quarter margin. The most significant mix impact came from very strong sales demand by our European indirect channel and this channel carries a lower-than-average margin. Turning next to adjusted operating margin. As you may recall on our third quarter earnings conference call, we indicated that during the fourth quarter we are planning to increase investment to support select high growth and strategic opportunities. As was planned, during the quarter, we increased the level of sales and marketing spending to further leverage the Vidacare product offering, and to prepare for the launch of our surgical micro-laparoscopic product line. We also increased spending on indices of development projects, as well as project registrations. As a result of the investment, fourth quarter SG&A as a percentage of revenue was approximately 120 basis points higher than our year-to-date average. This increase along with softer gross margin served to bring down the fourth quarter operating margin to 18.4%. On a full-year basis, we are able to absorb the increased SG&A investment and the gross margin shortfall while still achieving our original operating margin guidance of 20% to 21%. Looking to 2015, while we intend to continue to invest in support of Vidacare in other strategic opportunities, our 2015 financial plans also include offsetting SG&A cost actions. Therefore, we do not expect that SG&A will continue at this elevated level. Moving next to our adjusted tax rate. For the fourth quarter of 2014, the adjusted tax rate was 14.2%, a reduction of 700 basis points as compared to the prior year period. During 2014, we have benefited from a number of tax planning initiatives that served to bring our full-year sustainable tax rate down to approximately 21.5%. Our fourth quarter tax rate was further benefited by a positive shift in the mix of income to jurisdictions with lower tax rates, and the reinstatement of the R&D tax credit for 2014. The full-year rate impact of these items was trued up in the fourth quarter, which caused an atypically large quarterly benefit. On the bottom line, fourth quarter adjusted earnings per share came in at $1.43, or an increase of 5.1%. Our full-year EPS came in at $5.74, representing an increase of 14.1% and $0.04 above the upper end of our guidance range of $5.60 to $5.70. In addition to strong revenue and earnings growth, we also achieved a $59 million or 26% increase in 2014 operating cash flow. For the year, cash flow from operations was approximately $290 million. The increase was primarily due to improved net income, increased accounts receivable collections in Spain, Portugal, Italy and Greece, and a reduction in employee-related benefit payments. At the end of the year, cash on the balance sheet was $303 million, with $29 million in the United States. Leverage, as for our credit facility definition, stood at approximately 2.7 times. Combining our current cash balance with strong cash flow generation and availability under our credit facility, we are well positioned to fund business operations and pursue additional strategic opportunities. Now, let's turn to a review of segment revenue and constant currency growth results. Vascular North America fourth quarter revenue increased 10.2% to $68.7 million. The increase in Vascular revenue was largely due to the addition of Vidacare and higher sales of existing product offerings. Anesthesia/Respiratory North America fourth quarter revenue increased 0.7% to $58.2 million. The growth this quarter was the result of new products introductions such as disposable laryngoscope products and sales of the ISO-Gard Mask. Surgical North America fourth quarter revenue increased 9.7% to $40.8 million. The increase in Surgical revenue was due to the higher sales of existing products and an increase in average selling prices. EMEA fourth quarter revenue was up 8.9% totaling $146.9 million. The increase in EMEA revenue is due to higher sales of existing products, Vidacare product sales, the introduction of new products and price increases. Asia fourth quarter revenue increased 10.9% to $63.6 million. The quarterly increase in Asia revenue was primarily due to the acquisition of Mayo Healthcare and price increases with new product gains in Vidacare also adding to quarterly growth. This was somewhat offset by lower sales volumes of existing products. Turning to OEM, revenue for the fourth quarter increased 4.8% to $35 million. The increase in OEM revenue is due to the higher sales of existing products, in particular performance fibers and catheters. This was somewhat offset by a decline in the average selling prices on select products. And lastly, our other product revenue for the quarter was up 16.3% totaling $62.8 million. The increase in other revenue was largely due to Vidacare sales that fall under our specialty business call point and strong volume gains from our Latin American market. As we close out 2014, I'd like to take an opportunity to briefly review our 2014 performance versus the select financial targets that we had communicated at the beginning of 2014. In doing so, we can both celebrate the successes and highlight the areas requiring additional management attention going forward. Overall, we feel very good about 2014 as we delivered on all but one of the financial metrics that we outlined at our Analyst Day conference back in December 2013. We achieved constant currency revenue growth at the upper end of our guidance range, delivered on our operating margin goal and exceeded expectations for our tax rate, adjusted earnings per share and cash flow from operations. Twice during the year, we raised our adjusted earnings per share guidance. The one metric that we did not fully accomplished was gross margin, where we came in 50 basis points below our 2014 expectations. As we look to the New Year, we have well-thought out financial plans and productivity initiatives in support of our 2015 gross margin targets. Recognizing that unexpected events and circumstances do arise, we continue to look for additional actions that will further solidify our plans and provide a further cushion towards the achievement of our 2015 gross margin goal. In 2015, we have also placed a heavy emphasis on SG&A cost control, which will provide for better leverage throughout our P&L and will provide another means for creating meaningful margin expansion and shareholder value. As we exit 2014, we feel that our core operations are performing at a high level and that we are well-positioned to accomplish both our 2015 and our longer-term strategic goals and objectives. Next, I'd like to provide you with an overview of 2015 financial guidance. As an introduction to our 2015 guidance, I'll provide an update on Teleflex's exposure to currency moves and key trading currencies. By way of background, Teleflex aims to hedge its key transactional exposures to a rolling approach whereby we hedge the next four quarters at a level of 75%, 75%, 50% and 25% of estimated transactional exposure. We do not hedge currency translation exposure and approximately 50% of Teleflex's business is conducted in currencies other than the U.S. dollar. The euro represents our largest exposure and approximately one-third of Teleflex's revenue was conducted in this currency. We estimate that a $0.05 move in the U.S. dollar, euro exchange rate will impact adjusted earnings per share by approximately $0.20. For planning purposes, we have assumed 2015 euro-to-dollar exchange rate of $1.13 versus the 2014 average of $1.33. Our next largest exposures are with the Australian dollar, British pound, Canadian dollar, Chinese yuan and Japanese yen. Exposure to these currencies are limited by the fact that no more than 5% of Teleflex's total revenue was transacted in any one of these currencies. For 2015, we project that currency headwind arising from the combined impact of currency moves will reduce total reported revenue by approximately 6% and will reduce 2015 EPS by approximately $0.82. We also estimate that the relatively stronger U.S. dollar will negatively impact gross margins by 50 basis points and negatively impact operating margins by 100 basis points. These estimates are based on the current currency projections by bank economists for our key trading currencies. Now moving into the specifics of our 2015 guidance, for 2015 we expect constant currency revenue growth of between 4% and 6%. This growth will be driven by continued Vidacare penetration, base volume growth in line with recent trends, a modest acceleration of new product introductions, very modest core product pricing, already completed distributor-to-direct conversions and contribution from the recent acquisition of Mini-Lap Technologies. We'll go into more detail on revenue expectations a little bit later. Turning to gross margin. We currently project 2015 adjusted gross margin to increase 150 basis points to 250 basis points and be in a range between 53% and 54% for the year. As previously discussed, we anticipate that we will exit 2015 with adjusted gross margin at 55%. The projected gross margin increase is largely due to manufacturing cost improvement and productivity initiatives, positive mix including a continued benefit from Vidacare plus pricing and margin gains stemming from distributor-to-direct conversions and the acquisition of Mini-Lap. These gains will be somewhat offset by the unfavorable impact from foreign exchange which we estimate to be approximately 50 basis points. For 2015, we have made operating margin flow through a top priority and then built a 2015 financial plan that delivers a 200 basis point to 250 basis point increase in operating margin through a combination of gross margin gains and SG&A productivity. The SG&A productivity efforts allow us to not only drive margin gains, but to continue to fund both strategic investments and high margin, high growth opportunities such as Vidacare. We estimate that operating margin would have been approximately 100 basis points higher if it were not for foreign exchange headwinds. Similar to revenue, more detail will follow. Moving on to taxes. As mentioned, during 2014, a number of tax planning initiatives served to bring our full-year sustainable tax rate down to approximately 21.5%. Additional non-recurring benefits further reduced the 2014 adjusted tax rate to 19.9%. As we look to 2015, our tax rate jumping off point is at 21.5% sustainable rate achieved in 2014. We expect to show further improvement upon this rate, stemming from the full realization of actions taken place during 2014 and a more favorable geographic mix of profits. Our current projection is for 2015 tax rate in the range of 20% to 21%. And that takes me to our preliminary adjusted earnings per share outlook. For 2015 adjusted earnings is projected to be in a range between $6.10 and $6.35 per share and represents growth of between 6.3% and 10.6% when compared to 2014. We achieved this level of earnings despite an estimated $0.82 headwind from currency. Turning now to a more in depth discussion of the components of our revenue growth. For 2015, we are assuming growth in base business volume of between 135 basis points and 165 basis points. This base volume growth expectation assumes a continuation of the volume trends that we experienced during the second half of 2014, when third quarter volume increased by 190 basis points and fourth quarter volume increased by 185 basis points. New product introductions are expected to deliver between 75 basis points and 125 basis points of growth which represents a modestly strengthening pipeline versus the 87 basis points of growth that we achieved in 2014. Approximately half of the projected new product revenue is attributed to products that have already been launched and have traction in the marketplace today. Additionally, we expect that Vidacare will contribute another 40 basis points to 60 basis points of revenue growth. We continue to invest behind Vidacare as we like its margin profile and we see continued revenue penetration opportunities both domestically and internationally. Moving to our thoughts on pricing. Net pricing in our core business is expected to be flat to up 50 basis points. We continue to expect modest pricing opportunities will come from targeted markets and products. For 2015, we expect growth in our base business to increase between 2.5% and 4%. And by base business, I mean growth before the impact of M&A and distributor conversions. Our expectation is that the recent Mini-Lap acquisition will build momentum as the year progresses contributing between 50 basis points and 75 basis points of 2015 revenue growth. Distributor-to-direct conversions are expected to contribute between 100 basis points and 125 basis points of growth. We expect the growth will be split 50/50 between pricing and third-party sales. In total, constant currency revenue is projected to increase by 4% to 6% in 2015. And as a result of the stronger dollar, we expect a 2015 foreign currency headwind of approximately 6%. Turning next to gross margin improvements. As we look to 2015, we expect four key items to accelerate the rate of adjusted gross margin expansion by another 150 basis points to 250 basis points to a range of 53% to 54%. First, we have queued up a slate of specifically identified manufacturing and operations efficiency programs that will increase 2015 gross margin by approximately 100 basis points. Additionally, we expect a 30 basis point improvement from the full year impact of efficiency programs introduced in 2014. We project that stable product mix will add another 70 basis points to gross margin. Approximately one-half of this gain is expected from Vidacare. Two distributor-to-direct conversions are expected to add another 70 basis points and both distributor conversions have already taken place. Lastly, the recent acquisition of Mini-Lap is expected to yield an additional 10 basis points. These gross margin gains will be somewhat offset by foreign currency headwinds which we currently anticipate being approximately 50 basis points. Moving next to adjusted operating margins. We anticipate adjusted operating margin will increase by approximately 200 basis points to 250 basis points to a range of between 22% and 22.5% for 2015. Gains from gross margin will be the principal driver of the increase. While we look to further accelerate those gains through a combination of actions, including aggressive planning of our discretionary SG&A spending, the 2014 reorganization of our European country sales and marketing and finance organizations, and the reorganization of our North American Anesthesia and Respiratory sales forces, which drove both improved customer focus as well as expense productivity. The productivity actions will provide meaningful flow-through from our gross margin to our operating margin while also providing funding for strategic investments such as Vidacare marketing efforts or operating infrastructure required to execute the distributor-to-direct strategy. That takes me to our preliminary adjusted earnings per share outlook for 2015. This slide serves to bridge from our full year 2014 adjusted earnings per share results to our full year 2015 adjusted EPS outlook. Beginning with the 2014 amount of $5.74, we project our base business will add approximately $1.10 to $1.30 per share. And distributor-to-direct conversions and recently completed M&A are expected to add another $0.25 to $0.30. That takes us to a sub-total of $7.09 to $7.34 per share or growth of between 23% and 28% before the impact of foreign exchange, changes in share count and interest expense. We expect foreign exchange to impact our adjusted earnings per share negatively by approximately $0.82. Our current estimate is for adjusted weighted average shares to increase by approximately 600,000 shares to be approximately $44 million for the full year of 2015. As a result of these share increases, our earnings growth will be reduced by an estimated $0.09 per share. And finally, as a result of permanently financing the acquisition of Vidacare through the issuance of senior unsecured notes in May of last year, interest expense will provide an unfavorable comparable through May 2015 and is expected to reduce 2015 adjusted earnings per share by approximately $0.08. As a result, our 2015 adjusted earnings per share outlook is expected to be between $6.10 and $6.35 per share representing growth of between 6% and 11% versus 2014. And while recognizing that it is not our practice to provide specific quarterly guidance, I did want to highlight some considerations when thinking about the quarters. Overall, we expect quarterly constant currency revenue growth to be fairly consistent throughout the year, with the second half growth averaging about 100 basis points stronger than the first half. We expect revenue growth to be stronger in the second half due to the fourth quarter having one additional shipping day than the first quarter. Additionally, we expect that the revenue benefit from previously completed distributor conversions and M&A will increase as the year progresses. We also expect that EPS will be back end loaded for the reasons just outlined. In addition, during the second half, we expect a greater earnings benefit from both the footprint consolidation initiative and actions taken to offset the negative earnings impact of the stronger U.S. dollar. Conceptually, we expect 2015 quarterly EPS seasonalization to fairly closely approximate 2013 EPS seasonalization. Although the 2015 seasonalization will be a little more heavily weighted towards Q4 and a little less weighted towards Q1 due to the shift in shipping days. 2014 had very strong Q2 and Q3 earnings results and a lesser Q4 result and therefore would not be a good indicator of 2015 seasonalization. And that takes me to my closing remarks. To summarize, we have built a compelling financial plan for 2015. We have worked hard to identify productivity initiatives, to offset the unfavorable currency impact without sacrificing investment in key strategic initiatives. Our plan achieves key stated financial targets including sustainable constant currency revenue growth in the range of 5%, a 150 basis point to 250 basis point expansion of our gross margin and the achievement of a 55% gross margin as we exit 2015. For 2015, we were very focused on driving meaningful flow through to operating margin, and we built a plan that delivers more than 80% flow through of gross profit gains to operating profit gains. Our cash flow generation remains strong, and we project 2015 cash flow from operations to exceed $300 million. Combining our strong cash flow with $300 million existing cash on the balance sheet and a moderate leverage profile positions us well to continue to invest for the future and build shareholder value. That concludes my prepared remarks. And I'll now turn the call back over to the operator for questions. Operator?
Operator:
Thank you. Please stand by for your first question. Your first question comes from Larry Keusch, Raymond James.
Lawrence S. Keusch - Raymond James & Associates, Inc.:
Hi. Good morning.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Good morning, Larry.
Lawrence S. Keusch - Raymond James & Associates, Inc.:
So I just wanted to touch on the gross margin expansion and perhaps, Tom, you can kind of help us go through this a little bit. But as we dissect that improvement that you've outlined, one of the things I think I've been picking up from you guys is that the actual restructuring is a reasonably small portion of the gains that you get there. So again, I just want to make sure I'm understanding the components and how should we be thinking about the impact of the actual restructuring program in 2015.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Okay. Well, you're right. So, as we think about 2015, we have a number of drivers queued up that are going to move us towards where we want to be. Restructuring, certainly is one part or the footprint consolidation as we also referred to it as one part, but not everything. So, as we think about it, we talked about the combination of the footprint restructuring in operating efficiency programs delivering about 130 basis points of growth on a full-year basis. The majority of that is actually coming from operating efficiency. And there's really two components to that. One is a number of programs that we kicked off in 2014 and realized some of the benefit and as we closed out the year, we're going to pick up more of that benefit as we go into 2015. And also, we have another slate of projects that are scheduled for 2015. So, those initiatives will drive the majority of that operations efficiency. Footprint consolidation, we'll have some savings. So, we've got some one-time cost that we won't add back that will offset some of that. The majority of the footprint savings really kick in, in 2016 and 2017. And that's been kind of our plan all along. In addition to the ops efficiency, we also are expecting to realize gains from both the acquisition of Mini-Lap, as well as the (44:40). And collectively, they count for about 70 basis points of margin improvement. And those are already completed. So those are – we're fairly confident on those. And then, we're also expecting to get another 70 basis points coming out of mix. About half of that is coming from Vidacare and the continued growth coming from the investment we're placing in that product line. So those are the kind of the key legs to the growth story on margin. We also have got some benefits that come from oil pricing, although we're not expecting or not projecting as perhaps a bigger benefit as some others. So, as we think about it, really it comes down to driving the operations efficiency projects that we've got queued up, as well as realizing the benefits from mix and the distributor conversions.
Lawrence S. Keusch - Raymond James & Associates, Inc.:
Okay. Terrific. And then, just one for Benson, I guess the balloon pump business continues to present some challenges and has over the past couple of years. You again referenced it as having an impact this year or this quarter, I should say. So I guess the bigger picture question is, as you think about your portfolio and opportunities for rationalization, how do you think about the balloon pump business and perhaps some of the lower margin respiratory products that are in there as you think out over time?
Benson F. Smith - Chairman, President & Chief Executive Officer:
Well, I think one of the – certainly, one of my observations is that almost all segments of capital equipment in medical devices field are subject to a lot more unevenness and volatility as capital budgets are often the first thing that are hit in tougher times for hospitals. So, I mean one of the disadvantages is that it's always going to be lumpy compared to the rest of our businesses. Right now, as we sit here today, we're on the verge of introducing a new pump. We do expect some improvement in the Chinese capital equipment marketplace. So I think we're more optimistic about the immediate future of that business. But long range, we continue to evaluate whether we'd be best served to be more of a pure-play disposable business. I would say also that relative to our respiratory therapy business, some of the issues that were driving poorer performance the last two years have been resolved. We are more optimistic in terms of its performance in 2015, but I would say from a longer-term strategic view, it's not as good of a fit as some of our other businesses.
Lawrence S. Keusch - Raymond James & Associates, Inc.:
Okay. Great. Thanks very much. I appreciate it.
Operator:
Your next question comes from the line of David Lewis, Morgan Stanley. Please proceed.
David R. Lewis - Morgan Stanley & Co. LLC:
Good morning.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Good morning.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Good morning, David.
David R. Lewis - Morgan Stanley & Co. LLC:
Tom, I wonder if we could just may a little game of reconciliation for 2015. I think obviously the key element of this call is a great ability to offset this FX pressure. So relative to our model, it's about $0.40 of incremental FX pressure. It looks to me that a third to a half of that may be coming from better than expected tax. The other half of that, can you sort of walk us through what piece of shares, what piece is oil and perhaps what piece, or what is the impact of the Korea distributorship?
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
So, in terms – just so we're clear. When you say half of it is coming from tax, you mean going into 2015 relative to 2014?
David R. Lewis - Morgan Stanley & Co. LLC:
That's right. So the tailwind from tax looks like it's maybe $0.10, $0.15, perhaps $0.20. I don't want to put words in your mouth. Just looking to get the pieces.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Yeah. So let me just clarify what I talked about on the tax line. We had actually achieved a tax rate for the full year of about 19.9%, I think was the adjusted tax rate. And included in that were a number of one-time or non-recurring benefits. And so, once you strip those out, we are more in the 21.5%, 21.7% range on what we consider a normalized rate. And so, what I was talking about is that we're going to bring our tax rate down in 2015 from that normalized rate to a level of 20% to 21%, but recognize the actual rate we posted in 2014 was 99%. So if anything, we're at parity, perhaps a little negative. And we may get some benefit if they reinstate the R&D tax credit as we go into the next year. But as we think about what can be driving 2015, we think about it in a number of buckets in terms of what's going to be driving those earnings. And so, as I think about it, I've got about $1 worth coming from what I'll consider to be kind of core and revenue-related and that's been kind of our core revenue growth of 3.2% mix in pricing. We're also picking up another $0.25 to $0.30 coming out of acquisitions and distributor-to-direct conversions. And in operations, if I combine the impact of the footprint and the operations productivity, you're talking another $0.35 to $0.40. And then, we've got some pretty aggressive planning around the SG&A lines to make sure we're driving out of the budget as much of the discretionary spending as possible, as well as some restructuring of the EMEA country organizations last year that will provide a benefit into this year as we capture those full savings. We also reorganized our Anesthesia and Respiratory sales forces to actually bring them closer to the customer and in doing so, we're able to drive some efficiency there. And then we've got some continued savings as we fully integrate Vidacare and the Australia distributors and Mayo that add about another $0.40 of earnings. So, as we think about it, there is a number of drivers that are going to get us to that earnings level in 2015.
Benson F. Smith - Chairman, President & Chief Executive Officer:
I would just add to that, David, that we had been, for the last several years thinking that 2015 was the year we realized a lot of those leverage improvements in our P&L that we've been working on for the past several years. And fortunately, they've come out even a little bit better than we expected at a year when we needed with the euro.
David R. Lewis - Morgan Stanley & Co. LLC:
Okay. Very helpful. And then just maybe one question for Benson, another follow-up for Tom. I'll take the tactical one. Tom, the extra selling day in the fourth quarter, was there an extra day and what was the impact of that? And then, for Benson, Mini-Lap, obviously that's probably the biggest organic driver from a product pipeline perspective in 2015. Just kind of walk us through what you've seen by trialing, testing so far. What gives the confidence that you can get sort of that that gathering storm to potentially 75 bps in the back half of the year? Thank you.
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, I'll let Tom go first and then I'll pick up on Mini-Lap.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Yeah. So, we estimate the extra selling day in the fourth quarter to be around 62 basis points related to revenue and about $0.08 of earnings, if I recall the earnings impact.
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, I think first of all, we have a high degree of confidence in terms of their contribution for Mini-Lap. This had been a product that had been distributed by another company. In terms of our revenue projections, they're really just based on what the existing market numbers are as we make that transition. So, I would say that there's a low risk that we won't get the improvement for Mini-Lap. Our reason besides the obvious economic one for this year, really, it ties very, very nicely into our overall percutaneous laparoscopic line and gives us some broader exposure and we walk in to the hospital already with some business in our pocket in that particular segment, so we think it will be a good assist in our launching of our microlaparoscopic product line.
David R. Lewis - Morgan Stanley & Co. LLC:
Great. Thank you very much.
Operator:
Your next question comes from the line of David Turkaly, JMP Securities. Please go ahead.
David L. Turkaly - JMP Securities LLC:
Thanks. Just to kind of rehash some of your comments that European markets look stable and the U.S. looks slightly positive, sounds like you're gaining some share in the U.S. and raising prices as well. I guess, as you look at 2015, where you're sitting today, versus how you felt kind of at the beginning of the last two years, would it be fair to say that you feel that the core business is improving and maybe even the end markets kind of globally are showing signs of improvement?
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, I think the answer to that is, yes. Even in the area of China, where we had some slowdown. It was again, primarily in the pump business, not in our disposable business. I had dinner earlier this week with the head of one of the largest hospital systems in Philadelphia and while they're not seeing necessarily an uptick in in-patient procedure rates, they are seeing an uptick in acuity and that seems to be working in our favor. But also, we're making some significant in-roads in share gains. So, that's I think as much as anything responsible for our increasing growth change in our core products.
David L. Turkaly - JMP Securities LLC:
And then, just to clarify the earlier question. Obviously, the gross margin expansion this year, the impact of the facilities – the three that you moved – are really going to be more felt in 2016 and 2017, the operating efficiency and manufacturing productivity you're talking about, in 2015, is kind of incremental, exclusive of those impacts. Is that fair?
Benson F. Smith - Chairman, President & Chief Executive Officer:
That is correct. And I would say as you know, for some period of time, we've been talking about the fact that our gross margin improvement goals don't terminate in 2015 that we see some very good continuing runway in 2016, 2017 and 2018, and the particular restructuring program that's in place now really starts to kick in for us in a much bigger way in 2015 and 2017. So that's absolutely correct. As we had been able to generate other improvements in our gross margins from acquisitions and from some other things, I would say that allowed us to foot the relocation plans on a more conservative footing, and we have taken advantage of that. And that's another reason why their biggest gains will come in 2016 and 2017.
David L. Turkaly - JMP Securities LLC:
Thanks a lot.
Operator:
Your next question comes from the line of Matt Taylor, Barclays. Please proceed.
Matt C. Taylor - Barclays Capital, Inc.:
Hi. Good morning. Thanks for taking the question.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Good morning, Matt.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Good morning, Matt.
Matt C. Taylor - Barclays Capital, Inc.:
My first question is, you've been getting some benefit here and doing some additional distributor-to-direct conversions. I was wondering if you could just characterize the runway that you see there beyond 2015, and if we could see more kind of bigger transactions like this in 2015 and beyond.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Yeah. I would say Mayo last year was probably a little bit bigger than what we would do normally. I think 2015 is going to be largely representative of what you could expect to see in that arena for the next couple of years. And again, every time we do a new acquisition like a Vidacare, it usually opens up the door for additional opportunities. But even setting that aside for a second, I think you're going to see the same sort of continuation over the next couple of years as we continue to consolidate distributors.
Matt C. Taylor - Barclays Capital, Inc.:
Great. And then, organically, you've been making some investments in surgery and specifically micro-surgery and kind of have made another vet there. So I was curious as to how you see those products rolling out this year and what kind of contribution we could see, realizing this is kind of a new area for you.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Yeah. So, we have very conservative numbers in our plan for the rollout of the microlaparoscopic line. We certainly didn't want to put a budget together that had a lot of risk in what's an unknown product. We will be, again, having a soft product launch beginning first quarter, I think actually when we get to the Analyst Day, we'll have a much better insight in terms of what the adoption rate is going to look like and that will also determine the sales investment we put behind the product as well. So, it's a relatively conservative expectation this year. We're delighted that we're going to be able to put this rollout into place faster than we thought initially going into the year, but I think we'll have just a lot more information in our plans to spend some time on this certainly at the analyst meeting later in the spring.
Matt C. Taylor - Barclays Capital, Inc.:
Great. Thanks a lot.
Operator:
Your next question comes from the line of Matt Mishan, KeyBanc. Please proceed.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Great. Thank you for taking my questions.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Thank you.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
You bet.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
First question is Vidacare. I believe you previously said that you thought it could do about 100 basis points of organic growth alone next year. It looks like in your guidance it's kind of 50 basis points. Has anything changed in regards to your expectations there?
Benson F. Smith - Chairman, President & Chief Executive Officer:
Not really I think again as we were putting together the overall revenue budget this year, we wanted to make sure that there were some conservatism built into most of the individual line items. We didn't want to end up with the unpleasant surprise of missing on the revenue and therefore be under even greater cost pressure. So, it's -- I would say that it's more a matter of some conservatism. In fact, if anything I think I'm personally more bullish on the opportunity that Vidacare has for us over the next couple of years than I was even a couple of months ago.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Great. And you mentioned share gains a couple of times in the presentation. Where specifically are you guys gaining share?
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
So, our CVC business is taking an uptick. I think we've seen some improvements in our respiratory therapy marketplace. In fact for the most part, almost across the board in our U.S. based businesses, we've seen some improvements and again that's been helped enormously by 11 new GPO and IDN contracts that we closed just in the fourth quarter alone.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Okay. And then last question from me is that it's been I think 50 months since you've closed on Vidacare. What does the pipeline look like for like a Vidacare LMA type acquisition?
Benson F. Smith - Chairman, President & Chief Executive Officer:
I think the pipeline is good. We are seeing, I would say that we are seeing continued pressure and difficulties on companies that are in that size range. It's hard for them to go global. It's hard for them to penetrate into GPOs and we expect that to be a pretty good marketplace for us really over the next several years. So, we're picky about the things that we're looking at, but we certainly have a – I would characterize it as a robust target list.
Matthew Mishan - KeyBanc Capital Markets, Inc.:
Okay. Thank you and great quarter.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Thanks.
Operator:
Your next question comes from the line of Jason Wittes, Brean Capital. Please proceed.
Jason H. Wittes - Brean Capital LLC:
Hi. Thanks for taking the question. So, I wanted to ask about the Anesthesia/Respiratory business in North America. I think you've kind of mentioned that the performance has been a little bit under expectations; it's kind of running at flat to 1%. I guess I'd like to get your sense on what you think the normalized growth rate should be for that business. And secondly, as part of that, you had also mentioned that you'd made some changes. I know that you've made some sales force changes. But also, from what I spoke with you last, you talked about some clinical trial initiatives that you're going to take, which also could help this business. Could you kind of just walk through that business for us?
Benson F. Smith - Chairman, President & Chief Executive Officer:
I'll separate those two businesses out and because we have, in fact, now separated those selling organizations and assigned separate management groups, our respiratory therapy business really is concentrated almost entirely in locations where we have group GPO or IDN contracts. And we felt we could manage that with actually a very small targeted sales force. Usually, those conversions tend to be quite large in size. And we're only going to actually have a few of them each year. So, we're approaching that with a much more targeted sales force. We do have some improved products out. In that product line, we've got a new humidifier that's very competitive. As I said, we've made some good in-roads in some additional group contracts and we've been making some effort to improve the gross margins in that area. Anesthesia this year is going to be principally driven, I think, by some improvements in our LMA product line where we'll be launching the third-generation LMA device called the Protector during the course of 2015 and we will be capitalizing on an acquisition we made a couple years ago with their version of an all-silicone low-end LMA device with a pressure cuff indicator and we've been marketing this product in Europe for the last couple years and have really been pleased with their results of it, and we'll be rolling that out into the United States. We're also quite active in the disposable laryngoscope market, which is an emerging area that is really starting to take off for us, and we've seen some pretty good growth in our pain pump business as we go into 2015. So, we're looking at 2015 as being certainly pretty optimistic about both of those product lines compared to the last couple years.
Jason H. Wittes - Brean Capital LLC:
And where do you think normalized growth should be for those businesses?
Benson F. Smith - Chairman, President & Chief Executive Officer:
I couldn't quite hear your question, I'm sorry.
Jason H. Wittes - Brean Capital LLC:
I just wanted to get a sense of where you think normalized and/or market growth should be for those two businesses right now.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Yeah. I would say that they're probably a little lower than average and I would place it at 3% to 5% versus our 4% to 6% range for the rest of our product line. But, I would say, again, we may be being more cautious than we need to be. We're very interested in seeing how the Protector is received in the U.S. The folks we've had trying it in non-U.S. markets have been very, very enthusiastic about the product. So, I think we've got some conservatism built in there.
Jason H. Wittes - Brean Capital LLC:
Okay. And if I look at your Vascular North American business, again if I strip out Vidacare, there is definitely growth there. I'm not sure how to take out for the extra month from Vidacare, but roughly, it looks like something like around 2%, 3% for the remaining business. Again, my math could be slightly off. But could you give us a sense of how fast your PICC line and your CVC lines are growing right now?
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, PICC lines are growing faster than the CVC line obviously because we have more share. Jake, I'll turn this over to you.
Jake Elguicze - Treasurer & Vice President-Investor Relations:
Yeah. So our PICC business, this past quarter, was up about 11% on a constant currency basis.
Jason H. Wittes - Brean Capital LLC:
Okay. And CVCs, roughly?
Jake Elguicze - Treasurer & Vice President-Investor Relations:
CVCs were also up mid single-digits.
Jason H. Wittes - Brean Capital LLC:
Okay. Great. And then, one final question. I think it was asked in a couple ways earlier, but in terms of the gross margin progression, how should we be thinking about it? I know that you – I know a big component of that is a plant closure, but my understanding was that wouldn't really come into effect until largely the fourth quarter. Is that the right way to think about it? And can you give us a little bit more color in terms of how the gross margin progresses in 2015?
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, I would say that in quarter one and quarter two, there's not a lot of big movement. We start to see many of these issues or opportunities start to kick in really in Q3. And then, we're very close to where we need to be by Q3, and then some additional improvements in Q4. So, it is modest improvements during the first half of the year and some significant improvements starting to kick in in beginning of the third quarter.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
So you should expect to see a building gross margin as the year progresses. As a lot of these cost improvement programs are put into place and we start to realize those benefits. But to Benson's point, on the footprint per se, you're going to get an added bump in the fourth quarter as we start to realize some of those benefits from that action. So, it's kind of two different things happening. The cost improvements are ratable throughout the year and then at the close, a bump from the footprint.
Jason H. Wittes - Brean Capital LLC:
Very helpful. Thank you.
Operator:
Your next question comes from the line of Richard Newitter, Leerink Partners. Please proceed.
Richard S. Newitter - Leerink Partners LLC:
Hi. Thanks for squeezing me in. Just wanted to ask on the – you might have said this earlier, on the interest expense, that's an incremental kind of bad guy for 2015 relative to 2014 and on the shares. Can you just go over what exactly that was again?
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
So, on the interest expense, I think our average interest rate is right around 5.1% is our assumption. And I think a good way to think about that is if you take the third and the fourth quarter kind of spend rate, that's what you should expect to continue into 2015 because that will reflect the capital structure in place. And then in terms of our shares, we're expecting about a 600,000 share increase, in part due to normal equity grants and whatnot and in part due to the dilution associated with the converts. We're expecting that to be around $44 million, maybe $44.5 million is kind of the general range you should be thinking.
Richard S. Newitter - Leerink Partners LLC:
Okay. So, that's related to the convert. And then on the Mini-Lap, I think initially you said you're factoring in basically what the sales were from the prior distributor, but you also mentioned that there was something in the Mini-Lap pipeline that you found attractive. I was just wondering, is the pipeline just kind of more product line extensions to the existing portfolio or is there something in there that's maybe something that could be potentially more needle moving or category expanding, maybe elaborate on that?
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, I would say in our financial modeling of the acquisition, we tend not to put a lot of expectations around new product releases. I think that from what we have seen in terms of the product pipeline, it has the potential to have very, very significant growth compared to the base of business that they have now. I'm not sure that it amounts to something that would in and of itself move the needle a whole lot for Teleflex. I think the biggest contribution from the line comes – again, is really having a dedicated product line in this whole mini-laparoscopic area with Percuvance and with Mini-Lap and it's part of the overall product rollout strategy in that product line over the next year or two.
Richard S. Newitter - Leerink Partners LLC:
Okay. That's helpful commentary. And then just lastly, just with respect to restructuring, you announced one last year, and I know that you kind of left the door open for the potential for there to be restructuring 2.0 at some point, we're approaching them the mid-year mark, where you'll have your Analyst Day. Is that something that could potentially be in the cards in 2015 and does currency and the volatility we've seen in exchange rates in anyway impact the timing or kind of rationale or reasoning behind announcing something like that? Thanks.
Benson F. Smith - Chairman, President & Chief Executive Officer:
So the answer to the last question is not at all. These are moves that make sense regardless of what happens to currency one way or the other. I certainly think it's our expectation at our April meeting to be able to talk, I think, in some more detail about what our gross margin expansion programs should look like from a number perspective between 2016, 2017 and 2018. It's a natural restructuring plan. We're somewhat limited on commenting until we get board approval. So, I think our goal at the April meeting or at the May meeting has more to do with simply outlining the general areas where that improvement can come from and what we think or where we think we're going to be by the end of 2018. And I would say to add to that we continue to be quite bullish about our opportunity for gross margin expansion through that period.
Richard S. Newitter - Leerink Partners LLC:
Thank you.
Operator:
Your next question comes from the line of Anthony Petrone from Jefferies Group. Please proceed.
Anthony C. Petrone - Jefferies LLC:
Thanks a lot. Good morning. Maybe a couple just...
Benson F. Smith - Chairman, President & Chief Executive Officer:
Good morning, Anthony.
Anthony C. Petrone - Jefferies LLC:
Good morning. Maybe on Mini-Lap, a follow-up there would just be to maybe give us a sense of the margin profile of that business versus the corporate average and what you're expecting for 2015?
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, I think it's a safe assumption that every acquired product we have has a considerably better profile than what we've been selling, and we are reluctant to do things that don't have a seven in front of them at least.
Anthony C. Petrone - Jefferies LLC:
And maybe just to follow-up there. I mean it seems that these are lab instruments and you have the alliance with da Vinci. I don't think these wouldn't be compatible on the da Vinci system. But maybe just some comments on your broader outlook on minimally invasive surgeries where you seem to have two angles here; one is robotics, one is lab instruments. Maybe just to give us an idea of where you're seeing Teleflex's position as it relates to minimally invasive surgery broadly?
Benson F. Smith - Chairman, President & Chief Executive Officer:
So, we continue to work, I think, very well and have an excellent relationship with robotics company. We view that kind of as a specialty opportunity for us which we wouldn't venture into on our own without that relationship. The mini-laparoscopic instrument is entirely different. That really is a Teleflex pure play. As I mentioned earlier in the call, we are really looking forward to understanding the reaction and adoption rate that we can plan on. I want to be careful at this point in making sure we have enough initial customer experience before we start quantifying what that is. But at its very minimal level, it would more than meet our expectations from the modeling we did in the acquisition model. I would say we characterize this as one of those product areas that could be a lot bigger than what we thought just a year ago.
Anthony C. Petrone - Jefferies LLC:
That's helpful. Maybe to shift over to the APAC business, that was 13% of revenue through 2014 and I'm just wondering what percent of that is South Korea and sort of what tailwind you get from the distributor acquisition in that region?
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Just give us a second. We're just trying to dig up the data. I think it's about, call it, maybe about 4% give or take, $4 million. $4 million.
Anthony C. Petrone - Jefferies LLC:
Okay. And the last one for me is just on, on control of the Vidacare, the label extension for pediatrics, how large is that potential market for that indication? Thanks again.
Benson F. Smith - Chairman, President & Chief Executive Officer:
Yeah. So, again, for most pediatric indications, the market per se is not really big. It served as a really great entrée, though, because there's not a good alternative solution for those pediatric patients. And I would sort of describe it as a great backdoor to get into the hospital and get clinicians familiar with it. So it's probably going to show up more in terms of our ability to accelerate the growth of the rest of the on control line and necessarily as a discrete item.
Anthony C. Petrone - Jefferies LLC:
All right. Thanks a lot.
Operator:
Your next question comes from the line of Chris Cooley, Stephens Incorporated. Please proceed.
Chris Cooley - Stephens, Inc.:
Thank you. I appreciate you working me in here towards the end. Just two quick ones at this point for me, one maybe for Tom. Could you talk to us a little bit about the cash position there? Or maybe Tom and Benson there, when you think about it, most of that cash is domiciled OUS as you provided. Should we think about future M&A predominantly being international in its focus or any restrictions there that we should keep in mind? And then, I have just one quick follow-up. Thanks.
Benson F. Smith - Chairman, President & Chief Executive Officer:
So I would say that it's always – there's an obvious advantage if the acquisition happens to be domiciled outside the U.S. and we can use that cash for it. However, the bigger driver around our acquisition selection is, is it provide a clear clinical benefit? Does it help the hospital with the cost profile? Is it protectable? Is it going to be a product that really has a almost competitor-less opportunity in the marketplace. And the reason behind that strategy is we think those are going to be the most protected kind of enclaves in increasingly cost-concerned healthcare environment. So, we certainly wouldn't walk away from an acquisition that was U.S. based that met those other criteria. All things being equal, absolutely, we'd rather put our cash to work overseas.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
And we have been using that overseas cash for a number of these distributor conversions. So aside from something larger on the M&A front, as we look at these distributor conversions, there's a supply of cash to facilitate those.
Chris Cooley - Stephens, Inc.:
Super. And I realize the call's kind of long. I just had one other quick one here. Just when you look at the constant currency revenue guidance for the year, 4% to 6%, which is down year-over-year versus the 8.8% in the prior year, and I realize in 2014 you benefited significantly from Vidacare. Help me think though just about – I just want to make sure I got the math right here for 2015, what you're expecting in terms of just volume growth when we think about the components of that 4% to 6% for this year? How much of that is volume? Thanks.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Yeah. So, if we think about it, this year, we've got in our assumptions base volume growth of 135 basis points to 165 basis points. Now, we're also taking Vidacare kind of out of the M&A world, which was last year, and that effectively will roll into our base volume, but we're calling it out separately just so you can compare this year versus past. So, if I think about that base volume growth of 135 basis points to 165 basis points, that continues a nice trend that we saw in base volumes so we closed out 2014. We had been seeing volumes that were fairly negative across Europe and soft in North America in the early part of the year. As the second half came together, we saw a really nice strengthening of those base volumes in both North America and in Europe. And as a result, we closed out the year with 190 basis points of volume growth in the third quarter and 185 basis points in the fourth. So, as we look at 2015, we're assuming 135 basis points to 165 basis points, certainly our hope is that those trends of Q3 and Q4 continue at that level or higher. But we think what we've got is in line with what we've been seeing in the marketplace. And despite the softness in Asia, we still achieve those levels in Q3 and Q4.
Chris Cooley - Stephens, Inc.:
Okay. So, if I can just maybe push on that a little bit more. So, still the 135 basis points to 165 basis points down versus the rate we saw in the second half, even though we have a number of incremental drivers coming in now here into 2015. So, I'm assuming that's a bit of conservatism much like we saw you guys provide us at the start of 2014 as well. Is that the best way to think about that?
Benson F. Smith - Chairman, President & Chief Executive Officer:
That's the best way to think about it.
Thomas E. Powell - Chief Financial Officer & Executive Vice President:
Yeah.
Chris Cooley - Stephens, Inc.:
Fair enough. Thanks so much.
Operator:
You have no further questions at this time. Thank you.
Jake Elguicze - Treasurer & Vice President-Investor Relations:
Operator, I guess, if there's no further questions, I'll wrap up the call. Thanks for everyone to – for joining us today. This concludes the Teleflex Incorporated fourth quarter 2014 earnings conference call. Have a good day.
Operator:
Thank you for your participation in today's conference call. This does conclude the presentation. You may now disconnect. Good day.
Executives:
Jake Elguicze - Vice President of Investor Relations and Treasurer Benson F. Smith - Chairman, Chief Executive Officer, President and Member of Non-Executive Equity Awards Committee Thomas E. Powell - Chief Financial Officer, Principal Accounting Officer and Executive Vice President
Analysts:
David R. Lewis - Morgan Stanley, Research Division Lawrence S. Keusch - Raymond James & Associates, Inc., Research Division David L. Turkaly - JMP Securities LLC, Research Division Jason Wittes - Brean Capital LLC, Research Division Matthew Taylor - Barclays Capital, Research Division Anthony Petrone - Jefferies LLC, Research Division Matthew Mishan - KeyBanc Capital Markets Inc., Research Division Christopher C. Cooley - Stephens Inc., Research Division Ravi Misra - Leerink Swann LLC, Research Division Matthew O'Brien - William Blair & Company L.L.C., Research Division
Operator:
Good day, ladies and gentlemen, and welcome to the Q3 2014 Teleflex Incorporated Earnings Conference Call. My name is Allison and I'm your operator for today. [Operator Instructions] As a reminder, this call is being recorded for replay purposes. And I'd now like to turn the call over to Jake Elguicze, Treasurer and Vice President of Investor Relations. Please proceed, sir.
Jake Elguicze:
Good morning, everyone, and welcome to the Teleflex Incorporated Third Quarter 2014 Earnings Conference Call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing (888) 286-8010 or for international calls (617) 801-6888, pass code 14097601. Participating on today's call are
Benson F. Smith:
Thanks, Jake, and good morning, everyone. It's a pleasure to speak with you once again. Similar to prior calls, I'll start with an overview of the company's results and discuss some highlights. Moving on to performance during the first half of the year, we, as a management team, were once again quite pleased with results the company generated in the third quarter. Organic revenue growth improved both year-over-year and sequentially, primarily led by an improvement in domestic markets, the acquisitions of Vidacare and Mayo continue to positively contribute to our results and the company further expanded its operating margin. Combined, these items led to significant earnings per share and further position the company toward the achievement of our longer-term financial goals by the end of 2015. With that as a broad overview, let's review our third quarter results in more detail. Revenue in the third quarter exceeded our expectations and totaled $457.2 million. This represents an increase of 10.5% versus the prior year on an as-reported basis and 10.2% versus the prior year on a constant-currency basis. Our better-than-expected revenue in the third quarter resulted from the overperformance of Vidacare, our ability to continue to generate higher revenue from improvements in average selling prices, increased sales of existing products resulting from share gains and, we believe, a slight improvement in end-market utilization rates. And while we continue to be encouraged by some of the improvements we have seen recently in terms of the U.S. market, we believe it's still too early to call this a trend. Revenue growth in the quarter was somewhat tempered by a decline in year-over-year sales volume of existing products within our Asian segment. Some of the lower volume in Asia relates to a transition of a portion of our Asian business from a distributor to a direct model. This particular distributor has been selling off their existing inventory, and we have not been restocking the dealer. We expect this to continue through at least part of the fourth quarter, at which point we'll start selling direct to their customers and see a reversal. Regarding China. We believe the slowdown in their overall economy is slowing down the growth rate in hospital procedures. We are seeing some indications that some distributors are holding additional inventory. Inventory adjustments to reconcile with slower growth are likely to dampen fourth quarter revenue growth over the prior year period. I want to point out, we are still -- we still expect China to be one of the fastest growing markets over the next several years, but I expect that the future rate of growth will not be as robust as in the past few years. Turning to adjusted earnings per share. Third quarter 2014 adjusted EPS was $1.57. That compares to third quarter 2013 adjusted EPS of $1.33 or an increase of 18%. Similar to prior quarters, the improvement in year-over-year adjusted earnings resulted from higher volumes, continued improvements in average selling prices and a favorable mix of higher gross margin sales. In addition, we continue to generate increased leverage through the income statement from a lower adjusted tax rate when compared to the third quarter of 2013. These improvements were in spite of higher planned year-over-year operating expenses resulting from the Vidacare and Mayo acquisitions. Moving on to our 2014 guidance. Based on the company's performance during the first 9 months of 2014 and our outlook for the fourth quarter, we are increasing our full year constant currency revenue growth range from 7% to 9%, to 7.5% to 9%. We are also increasing our full year adjusted EPS guidance range from $5.45 to $5.60 per share to a range of $5.60 to $5.70 per share. Regarding our revenue guidance, we are taking a cautious approach as we exit the year. During the third quarter, we did see an improvement in the U.S. market and continued stabilization of European markets. However, as I stated earlier, we are monitoring our Asian business closely. In many Asian countries, we go through several layers of various distributors and it can be difficult to get accurate sell-through information. Since we are still in the process of trying to gather additional information, we decided to take a more modest approach in raising our guidance than might seem appropriate given our overperformance in the last several quarters. From an EPS perspective, given the strong performance in the third quarter, we feel more comfortable in further raising our EPS guidance range. As I stated on last quarter's earnings conference call, we intend to increase spending against certain higher-growth and higher-margin products as we exit the year with the hopes that pulling forward the spending into 2014 will lead accelerated growth in 2015 and beyond. In addition, based on current foreign exchange rates, we expect foreign currency to be a headwind during the fourth quarter. Finally, we do not anticipate the same level of tax benefit to occur in the fourth quarter that occurred in the third quarter. All of the previously mentioned items lead us to conclude that our earnings for the full year will likely be between $5.60 and $5.70 per share. And during his prepared remarks, Tom will discuss some of the puts and takes between our third quarter adjusted earnings per share performance and what we expect to occur in the fourth quarter. Next, I'd like to discuss third quarter volumes, pricing, GPO and IDN contract awards and new product introductions in more detail. During the third quarter, sales volumes in core products improved and contributed approximately 190 basis points of revenue growth. This growth was stronger than initially expected and occurred across a wide range of our businesses, including OEM, Vascular and Surgical North America and European segments. Turning to pricing. During the third quarter, the average selling prices of our products once again expanded when compared against the prior year. This past quarter, the improvement in the average selling prices of products contributed approximately 111 basis points of revenue growth and resulted from a combination of distributor-to-direct conversions as well as core product price increases. From a segment perspective, we saw price improvements highest in Asia and as expected, this was primarily due to distributor conversions. This was followed by improvements in pricing we were able to generate in our North American Surgical and European segments. Continuing the trend from the first half of the year, these price improvements were somewhat offset by a decline in the average selling prices of some of our OEM product offerings. Moving on to new product introductions. During the third quarter, new products contributed approximately 78 basis points of revenue growth. While this was below our original expectations, revenue growth from new products was up modestly on a sequential basis during the quarter as we continued to see nice growth coming from our ArrowADVANTAGE5 PICC, LMA Supreme and European ASK CVC Kit Procedures [ph]. ISO-Gard is taking longer to work its way through hospital approval committees. While it protects the recovery room nurses from dangerous exhaled anesthesia gas levels, it is an additional expense for hospitals. We're receiving good support from nursing organizations and expect, over time, this will become a standard practice. Shifting gears, the third quarter of 2014 saw a continued expansion of contractual agreements between Teleflex and our GPO and IDN partners. During this past quarter, Teleflex won a total of 12 agreements, 8 of these agreements were new and included product categories like dialysis, laryngoscopes and pain management. Next, I'd like to update you on Vidacare. Vidacare contributed approximately $22 million of revenue and 5.3% or a little over half of Teleflex's constant currency revenue growth. This represents the strongest quarter yet of Vidacare product sales, and if you were to compare these results to the third quarter of 2013, it would show that Vidacare's revenues increased approximately 24% on an as-reported basis. In addition, during the quarter, we had 2 positive product announcements regarding Vidacare. The first was the 510(k) clearance was received for restated indications for use of the EZ-IO Vascular Access System. The EZ-IO is now indicated to include the distal femur for pediatric patients. We pursued this indication expansion because of input we received from clinicians, and we believe this opens up a new growth opportunity for us. The second positive development occurred in early September when the EZ-IO Vascular Access System reached a new growth milestone by surpassing 3 million needles sold. Achievement of this milestone demonstrates that the intraosseous access is gaining further acceptance in emergency and difficult vascular access situations. I'd like to point out that during the fourth quarter, we'll reach the anniversary of the acquisition of Vidacare and it will no longer appear as acquired growth. Based on its current trajectory, we remain comfortable that Vidacare could add approximately 1% of additional organic revenue growth for Teleflex in 2015. Moving on, I'd like to update you on another positive development as it relates to a prior acquisition. During the third quarter, the company was awarded a $2.1 million research grant from the U.S. Army's telemedicine and advanced research center to support research and development of a surface modified nail that combines the Semprus Sustain Technology with antimicrobial technology. An additional $2.5 million in funding for the project may be provided under the award at the Army's discretion. This award builds upon an initial grant awarded to Semprus in 2011 to develop the world's first orthopedic devices designed to reduce biofilm formation. We're pleased to be able to partner with the U.S. Army to develop a solution to an unmet need in orthopedic injuries. And finally, let me briefly update you on the acquisition of Mayo Healthcare. Acquired in February, the integration of this Australian distributor is on schedule and the business continues to perform quite well. During the third quarter, Mayo contributed approximately $6.5 million or 156 basis points of Teleflex's constant currency revenue growth. Approximately 2/3 of the revenue growth came in the form of additional volume, while 1/3 came in the form of price increases. That completes my prepared remarks. For planning purposes, I would like to let you know that we plan to provide our fiscal year 2015 guidance in February in conjunction with our year-end 2014 earnings release. It is our belief that waiting until February to provide guidance will allow us to have additional visibility into general global economic conditions and foreign currency exchange rates, as well as other events that may influence our 2015 guidance. Finally, I would like to inform you that we plan on having an Analyst Day event in late spring. This event will allow us an opportunity to provide longer-term goals and objectives as well as an update on the strategic initiatives that will play a key role in the achievement of those goals and objectives. Part of this discussion will include an update on our 2014 facility restructuring program, which continues to progress well in its initial phases. During his prepared remarks, Tom will provide you a more detailed review of the process we've made in this area, as well as a review of our financial results during the quarter and guidance for the remainder of 2014. Tom?
Thomas E. Powell:
Thanks, Benson, and good morning, everyone. During the third quarter, revenues were $457.2 million, which represents an increase of 10.2% on a constant-currency basis. Approximately 5.3% of constant currency revenue growth was related to Vidacare, with the remaining 4.9% of growth coming from distributor-to-direct conversions, an increase in core product volumes, core product price increases and revenues from new product introductions. Turning to gross profit. For the third quarter, adjusted gross profit was $238.1 million versus $205.8 million in the prior year quarter. Adjusted gross margin increased 234 basis points to 52.1%. The increase in adjusted gross margin was primarily due to Vidacare and distributor conversions, with product pricing and product mix also making a positive contribution. Further gross margin gains were limited by higher-than-anticipated manufacturing costs. Turning next to adjusted operating margin. For the third quarter, the adjusted operating margin increased 133 basis points to 21.7%. The year-over-year improvement was the outcome of the gross margin gain, offset by additional SG&A expenses associated with the Vidacare and Mayo businesses and increased sales commission and bonus costs associated with the higher level of revenues. Moving next to our adjusted tax rate. For the third quarter of 2014, the adjusted tax rate was 18.8%, a reduction of 500 basis points from year-ago levels. The improvement in the tax rate was a result of benefits realized from tax planning initiatives and a favorable shift in the mix of income to jurisdictions with lower tax rates. On the bottom line, third quarter adjusted earnings per share came in at $1.57 or an increase of 18%. Additionally, we continue to leverage the growth in earnings to drive operating cash flow. The first 9 months of 2014, cash flow from operations reached $208.8 million, representing an increase of 54% versus the comparable period of 2013. The improvement in cash flow generation was largely due to the growth in earnings, improved working capital and reduced pension contributions. At the end of the third quarter, cash on the balance sheet was $286 million, with $62 million in the U.S. Leverage, as reported per our credit facility definition, stood at approximately 2.74x. Combining our current cash balance with strong cash flow generation and availability under our credit facility, we are well positioned to fund business operations and to pursue strategic opportunities. Next, let's turn to review of segment revenue results. Vascular North America third quarter revenue increased 16.1% to $63.8 million. The increase in Vascular revenue was largely due to the addition of Vidacare and higher sales of both new and existing product offerings. Anesthesia/Respiratory in North America third quarter revenue increased 1.8% to $54.7 million. The growth this quarter reverses the year-over-year revenue declines this segment experienced in the first half 2014 and was a result of improving volume trends for existing products, new product introductions and price increases. Surgical North America third quarter revenue increased 6.2% to $36.1 million. The increase in Surgical revenue was due to higher sales of existing products and an increase in average selling prices. EMEA third quarter revenue was up 5.6% totaling $141.2 million. The increase in EMEA revenue was due to Vidacare product sales, higher sales of existing products, introduction of new products and price increases. As was mentioned earlier, revenue in Asia was softer this quarter versus what we have experienced recently. For the quarter, constant currency revenue increased 11.8% to $62 million. Quarterly increase in Asia revenue was primarily due to the acquisition of Mayo Healthcare and price increases, with new product gains and Vidacare also adding to quarterly growth. The area where Asia has slowed versus recent quarters is in volume trends for existing products, particularly in Japan, where we are managing through a key distributor transition. Turning next to OEM. Revenue in the third quarter increased 15.9% to $39.2 million. The increase in OEM revenue was due to higher sales of existing products, in particular, sutures, and the introduction of new products. This was somewhat offset by a decline in average selling prices on select new business. And lastly, our other product revenue for the quarter was up 22.3%, totaling $60.2 million. The increase in other revenue was largely due to Vidacare sales that fall under our specialty business call point. During the third quarter, the Latin American business, which also falls under our other segment, was down slightly year-over-year as a result of soft business in Brazil and a tough year-over-year comparable in Venezuela. Next, I'd like to provide you with an update regarding our manufacturing footprint restructuring plan. Since our last earnings conference call, we have made progress on the initial phases of our facility restructuring initiatives. We have now provided notice to employees at our Mountain View, California location that we'll be closing the facility and shifting production to our Czech Republic location. We have also secured additional space at a key receiving site in Mexico and expect to begin production transfers later this quarter. From a financial standpoint, we continue to estimate that the company will incur aggregate pretax charges in connection with the plan of approximately $42 million to $53 million, of which approximately $32 million to $40 million will result in future cash outlays. In addition, we continue to estimate that the aggregate capital expenditures associated with this program will be approximately $24 million to $30 million, and that we will achieve annualized savings of approximately $28 million to $35 million once the plan is fully implemented. We continue to expect to realize plan-related savings beginning in 2015, and we expect that the plan will be substantially completed by the end of 2017. However, as we have gotten more precise on the timing of specific initiatives, we are updating our estimates for 2014. We now expect that the company will incur approximately $15 million to $17 million of the aforementioned pretax charges in 2014, of which approximately $5 million to $7 million will result in cash outlays. We also expect 2014 capital expenditures associated with the plan to be in the range of $8 million to $10 million. Finally, we expect 2014 pretax expenses, which will not be added back when calculating adjusted earnings per share, to be in the range of $4 million to $5 million, down slightly from our prior range of $5 million to $6 million. In summary, we continue to expect that total project spending and savings targets are in the same ranges as previously provided. Where there is some potential variability is in the timing, and that is what you are seeing with the revised 2014 project spending outlook. Next, I'd like to provide you with an update regarding our full year 2014 financial outlook. As we began the year, we had advised that we are taking a conservative view on first half revenue, given uncertainties surrounding how volumes would be impacted by the rollout of the Affordable Care Act and the soft European economy. As it turns out, our Q1 volumes were soft, down 150 basis points. However, volumes have since improved, achieving an increase of 110 basis points in Q2, and an increase of 190 basis points in Q3. Given the improving volume trend, coupled with above-planned performance on the Vidacare and Mayo acquisitions, we now feel confident to again adjust upwards our financial guidance. As such, we are increasing our 2014 outlook for constant currency revenue growth to a range of between 7.5% and 9%. This is an increase from our prior constant currency revenue guidance of between 7% and 9%. We are also increasing our 2014 GAAP or reported revenue growth expectations to also be in a range of 7.5% to 9%. In coming up with the GAAP revenue expectation, we assume that the current U.S. dollar-euro exchange rate will remain in its current trading range for the balance of the fourth quarter. We transact approximately 30% of our business in euros, therefore, the translation impact of a move in the currency can have a meaningful impact on our reported financial results. Based on this expectation for the euro, we project foreign currency translation to be a headwind to revenue of approximately 3% for the fourth quarter. Now turning to adjusted gross margin. We continue to project adjusted gross margin to increase by 240 to 290 basis points over 2013 levels, and to be in a range of between 52% and 52.5% for the year. However, we currently expect to be toward the lower end of the range, largely due to $4 million to $5 million of expense associated with the footprint consolidation project, which was not contemplated in our original gross margin guidance and will not be added back when calculating adjusted gross margin. Moving on to adjusted operating margin. For the full year of 2014, we continue to expect adjusted operating margin, excluding intangible amortization expense, to increase by approximately 100 basis points to a range of 20% to 21%. As we stated on prior earnings conference calls, we anticipate that further gains in adjusted operating margin will be tempered by investments to support our distributor-to-direct strategy and the addition of Vidacare. Moving on to taxes. We expect our adjusted tax rate in the fourth quarter to be slightly better than our September year-to-date adjusted tax rate of 21.7%. This is an improvement from our prior guidance, which called for a full year 2014 adjusted tax rate of 22.5% to 23.5%. And finally, on the bottom line. As a result of the company's performance during the third quarter and our outlook for the fourth quarter, we are increasing our full year adjusted earnings per share guidance from the previous range of $5.45 to $5.60 per share, to an updated range of $5.60 to $5.70 per share. Despite today's increase in full year earnings guidance, our outlook implies a sequential decline in our adjusted earnings per share from the third quarter to the fourth quarter. There are a few reasons that I can point to for the sequential decline. First is the impact of foreign currency translation. We are currently projecting that foreign currency translation will be a headwind to the fourth quarter earnings versus a tailwind in the third quarter. For the fourth quarter, we estimate the resulting sequential earnings impact to be a negative $0.08 to $0.10. Second, our fourth quarter tax rate is expected to show improvement over the year-to-date tax rate. We do not expect to replicate the tax rate realized in the third quarter. As a result, we are expecting that the tax rate will be a sequential headwind of approximately $0.05. Additionally, we had a couple of one-off expense benefits during the third quarter that we do not expect to reoccur. We also expect additional dilution related to the convertible notes. And finally, as previously discussed, we have plans to make additional investments in the fourth quarter in support of select high-growth or strategic opportunities. And now, in closing. We continue to build a financial model that contains a portfolio of earnings-accretive strategies, aside from reliance on top line growth. We believe such an approach will allow us to somewhat insulate our results from macroeconomic influences beyond our control and will allow us to continue to deliver strong earnings growth regardless of the economic climate. Some of the strategies that have worked well this year include
Operator:
[Operator Instructions] Your first question comes from the line of David Lewis from Morgan Stanley.
David R. Lewis - Morgan Stanley, Research Division:
Benson, I appreciate your comments about the fourth quarter, specifically. I think generally very clear. Just on the low end of guidance for the fourth quarter, that's a more material step than what we expect. Can you just talk about the factors that would bring the low end guidance into perspective in addition to the commentary you've already provided? And I had a couple of follow-ups.
Benson F. Smith:
So I think if we took the most conservative view possible, not the most likely view, but the most conservative view possible, it brings us with the risk of being below 8%. Typically, we've done this in half percentage increments, so the next increment below that is 7.5%. It's not the most likely scenario, but we didn't want to be in the position where we gave our guidance now and had to adjust it further in the year if those most conservative potentials turn into realities.
David R. Lewis - Morgan Stanley, Research Division:
Okay. And then maybe just 2 other quick ones. The first question is just in terms of next year's guidance, and I appreciate we're not going to get that for several months now, but maybe some sort of broad macro guideposts you could provide, specifically around, and for Tom, tax, and the ability to get the 55% gross margins by the end of '15. And then Benson, maybe for you, just given what you've seen here in 2014, the ability to get to a mid-single-digit type organic growth progression. And then just one more and I'll jump back in queue.
Thomas E. Powell:
Okay. Well, as mentioned, we do intend to give specific guidance as we release our fourth quarter earnings. But just in terms of general, on tax, we had made a commitment to get to 23% on an adjusted basis for 2014 and to be able to carry that rate forward into the future. As we look at where we are this year, we're a bit ahead of that. Some of that is due to some discreet items that we won't be able to replicate. But as I look at that 23%, we feel pretty good about that number, and our goal is to try and bring it down from that. So I would think that 23% would be the higher end and we're working obviously to try and get closer to where we are this year. But again, this year's got some discreet items in it. As for the 55%, our commitment all along has been to achieve 55% as we exit 2015. You heard a bit about the facility footprint project is underway and moving forward, so we feel good about its progress to date. We have a number of other actions that will help us to get to that 55%, we feel good about those plans. So if anything, the discussion about 55% is, one, about timing, not necessarily getting there. So if there were any comment that I'd leave you with is, we feel good about the 55%, we feel good about our ability to get there and perhaps further, the question could be on the variability of when exactly that date occurs. Now we'll give more specific guidance on that as we get into our earnings release for the fourth quarter and providing the guidance. But essentially, we feel pretty good about that 55% right now.
Benson F. Smith:
So just, I think, commenting on at least the way, internally, we look at our existing organic growth rate, it's probably more favorable than just using some arithmetic. We're looking at our volume growth, which is now at about 190 basis points, new product growth. I'm going to label it's probably likely to be between 80 and 100 basis points for the year. We think there are some potential to uptick that in 2015 based on our product rollout calendar. Although all the Vidacare revenue this year is counted as acquired growth, a percentage of that is, in fact, organic growth, and so that will go into our organic growth rate starting in December of this year. And then we're going to see a constant stream of dealer-to-direct activities. So this year, for example, we're getting some benefit from Australia, but we're also getting some negatives as a result of the dealer-to-direct transition in Japan. So when we net those out, I would say that we're -- and taking all those things cumulatively, we're between that 4.5% and 5% organic growth rate as we stand today.
David R. Lewis - Morgan Stanley, Research Division:
Great. Well I know it's early, I appreciate all that feedback. And just maybe one last one, Benson. The message last quarter was we see some SG&A upside, we're going to reinvest that back to certain products, specifically Vidacare and very strong growth from Vidacare. The other pipeline, excluding -- other pipeline products, excluding Vidacare, took a small step forward but clearly is a little below expectations for the year. Is there not some opportunity to reinvest some of this incremental upside into some of the other pipeline products, x Vidacare. And maybe just talk to us about some of the factors that have weighed on the progression of the other Vidacare pipeline programs in '14, and I'll jump back in queue.
Benson F. Smith:
Yes, so the short answer to your question is, yes. We are quite excited about the launch of our Eon product line, which is the mini laparoscopic line of instrumentations. We actually thought we were going to launch that in Europe in the fourth quarter. And a leading institution in the United States asked us to delay it until first quarter when we had U.S. approvals so they could be the global launch of the product, but that is certainly consuming some resources as we prepare to launch that product. I mentioned ISO-Gard, that's going to continue to take some investment in channeling that nurse organization enthusiasm for the product into hospital conversions. So we're really not short on opportunities. I think, one of the issues is, when we decided to pull the trigger, midway -- it was almost midway through the third quarter when we had our second quarter earnings call, it just takes a little time to get those in place, and we weren't able to see the benefit of any of that additional spending in the third quarter.
Operator:
The next question comes from the line of Larry Keusch from Raymond James.
Lawrence S. Keusch - Raymond James & Associates, Inc., Research Division:
Benson and Tom, I just want to come back to make sure I'm understanding the gating issues associated with the restructuring. It certainly sounds like, Tom, that you guys remain confident in your ability to hit the 55% gross margin, but perhaps the ability to get there exiting the fourth quarter in 2015 maybe now a bit in question. And so, I guess, I just want to understand, what exactly are the moving parts, and make sure I'm interpreting that correctly. And then I've got one other one.
Benson F. Smith:
So let me just jump in on the first part. We certainly did not mean to imply that it's in question. I think we have always said that as this project progresses, there is a possibility that we delay closing a facility because of supply issues, et cetera, that's just part of the risk and that if there's any risk to us, it is in timing, not in actually getting to the 55% number. So we really haven't changed our thinking about that, and if it seemed like there was an inference to that point, let's correct that.
Lawrence S. Keusch - Raymond James & Associates, Inc., Research Division:
Okay. And Tom, on the -- so what's changing out there relative to -- it sounds like you're going to take some expenses this year perhaps that you are not anticipating. So again, if you could just walk us through that, it will be really helpful.
Thomas E. Powell:
Actually it's going to be less, not more.
Benson F. Smith:
Are you talking about the footprint project now?
Lawrence S. Keusch - Raymond James & Associates, Inc., Research Division:
Yes.
Thomas E. Powell:
Yes, so essentially what we've outlined now is spending this year -- there's a couple adjustments, none of them that significant, but we are just providing an update as to where our current spending is. So if you like, I can walk you through where we were and where we are now. So capital, initially, we had talked about $10 million to $15 million in the year, we now estimate that to be in the range of $8 million to $10 million. In terms of the restructuring -- restructuring-related expenses, we had previously discussed $22 million to $23 million, we're now expecting $15 million to $17 million. And then other operating expenses, previously were $5 million to $6 million, we now see those as $4 million to $5 million. So just getting back on the point on timing, as we laid out the initial expectations, those are the numbers that we thought we would initially spend. We've now gotten closer to the actual projects and what's going to be involved, and we've got more fine-tuned numbers. And so some of that will be coming forth in the first quarter versus in December of this year. So again, we don't expect any change to the total cost of the entire project. We don't expect any change to the total savings estimate. However, there is a bit of a timing shift here. And again, I wouldn't read too much into that timing shift other than just a refinement of the estimates.
Lawrence S. Keusch - Raymond James & Associates, Inc., Research Division:
Okay, perfect. And then the last question is, again, just from a high level, you guys have been very effective in obtaining price increases through a variety of means over the last 3 years across virtually all your geographies. But again, could you help us think about that and maybe perhaps help set expectations for how we should be thinking that -- about those abilities to drive price increases as we move forward into 2015?
Benson F. Smith:
So obviously, this year, a percentage of what is recorded as price increases comes from dealer-to-direct conversions. We are certainly going to see that continue on through the next several years. It's also responsible for part of our planned margin improvements over those next several years as well. I think we have been positively surprised at our ability to continue to get some non-distributed direct or core pricing up. And I think, in several occasions, we talked in the past about the fact that one of the things that we feel best about is instilling that pricing discipline within our businesses, where they are on the alert for those opportunities to be able to raise prices in certain markets in certain products. So we had been kind of reluctant to not put a longer-term goal out there as we did a couple of years ago, but I think we're still going to continue to see benefits from both those things, dealer-to-direct conversions and also just that inherent pricing discipline now.
Operator:
The next question comes from the line of Dave Turkaly from JMP Securities.
David L. Turkaly - JMP Securities LLC, Research Division:
Just 2 quick detail ones, and then a follow-up. So for fourth quarter, just to check the math, the EPS range is $1.29 to $1.39. And then secondly, quickly, was there any impact from extra day or less day in this quarter?
Benson F. Smith:
No, that would be a fourth quarter event.
David L. Turkaly - JMP Securities LLC, Research Division:
So the math is good, and just the days were flat with last year in the third quarter?
Benson F. Smith:
Yes.
Thomas E. Powell:
Correct.
David L. Turkaly - JMP Securities LLC, Research Division:
Okay. And then -- and so when we look at the second quarter, we had sort of an uptick in European utilization. And then in this quarter, it seems like your 3 kind of North American businesses all saw a nice sequential uptick and then we had sort of this new news in Asia, but it's kind of a small part of your mix. I guess, as we're looking ahead, how long do you think this drag kind of lasts? And then are we expecting sort of -- should we expect that business flattish sequentially as we look forward or down 5% to 10%? I guess any sort of color there because it seems like the majority of what you have is actually improving this year.
Benson F. Smith:
So I think just overall, our longer-term view of Asia, China, in particular, is that it's still going to be a growth opportunity and we still see that as an area of investment for us. I think the larger point we're just trying to make here, that I don't think that the growth rates that have been typical out of China for the past 5 years are likely to continue at that same robust number. But I would still say our longer-term expectation is that China grows somewhere between 6% and 8% in our product categories, which still makes it one of the healthiest growers around the world, and we continue to make investments there. The situation in Japan is a very much more time-sensitive kind of thing. We stopped selling to the distributor a couple of months ago, he's selling off his inventory, as I mentioned in my remarks. That process will be concluded sometime in mid-November, we estimate, and then we'll start to sell those hospitals directly. So we'll see a pretty dramatic recovery to Japan as soon as he's out of inventory.
David L. Turkaly - JMP Securities LLC, Research Division:
Okay. So overall, it doesn't seem like we're going to be looking at declines, but just maybe slower, I mean, even in this quarter, it was still a decent growth number, just not as robust as it once was.
Benson F. Smith:
Correct.
Operator:
The next question comes from Jason Wittes from Brean Capital.
Jason Wittes - Brean Capital LLC, Research Division:
So a couple of questions here. First off, within Anesthesia, the percentage growth numbers did improve, but you also mentioned that ISO-Gard was off to a slower start than you anticipated. Is that just a case of easy comps or is there some fundamental changes there that we should be aware of in that business?
Benson F. Smith:
The easy comps for the Anesthesia/Respiratory business begin in fourth quarter. We had a GPO loss 1 year ago that has been negatively impacting their sales for that entire period. I think that expires -- or 1 year anniversary in the fourth quarter. ISO-Gard is, I would just say, is a product I still have a lot of confidence in. It's a very different sell, it's not a clinical sell, it's almost a workers' safety issue sell, and we are thinking more and more about what we need to do to support that process and try and expedite it. But in the economic climate in the hospital space, it tends to get tied up into these economic value committees in hospitals, which meet slowly and make decisions slowly.
Jason Wittes - Brean Capital LLC, Research Division:
Okay, helpful, I see. Also, you mentioned for last year some excitement. You mentioned ISO-Gard, but you also mentioned Eon will be launched in the first quarter. My understanding was that's going to take some time to sort of develop into the market. There's, I assume, some -- a fair amount of training to be done, et cetera. But -- so should we be thinking that, that will be a driver next year or is that just potential upside next year?
Benson F. Smith:
I would characterize it at this point as potential upside for next year. Our expectation is, is that after the launch in the first quarter in the U.S., we're going to be -- roll it out to a limited market release to make sure that the training and educational programs we put together are, in fact, adequate to get physicians comfortable with using it. I would say, though, I continue to be really optimistic about physician interest in this product line, and we continue to anticipate to make other investments to kind of broaden that out.
Jason Wittes - Brean Capital LLC, Research Division:
Okay. Great. And then just a general question on FX. You mentioned the impact this quarter, which will be more pronounced than the -- earlier this year. But should we start to think about that and how that might impact next year? Should it -- do you have any comments on kind of how you think FX shapes out next year and how we should be thinking about it when modeling?
Benson F. Smith:
So our thought is -- might not help you much in that area, our thought is there's a lot of volatility going on in currency. Just this week, the euro bounced around quite a bit, and that's one of the reasons why we think we're better served giving guidance time to our fourth quarter earnings release. Having a clear idea of what it's at least likely to look like, and then also understand whatever other mitigating strategies we've been able to put into place to counter that. But I would tell you, every year, we look at what the top 50 banks think is going to happen to the euro next year and the only consistent thing that's happened is they've been wrong each of those 4 years. So we sympathize with your effort to try and pin that down.
Jason Wittes - Brean Capital LLC, Research Division:
Fair enough. I appreciate the color. Just on hedging itself. What kind of hedging do you have in place now and what kind of hedging could you put in place to change that over the next few months if you had to?
Thomas E. Powell:
Well, we largely think about hedging as a way to protect economically versus from an accounting standpoint. So we're largely hedging transactions where we're transacting in other currencies. We do not currently hedge against translational impact or the accounting impact of translating our foreign books to U.S. dollars. And as we look at that, the cost and other associated complexity of that, we concluded that's not a path we're going to go down. So we're going to continue to be exposed to that translational impact. The currency that impacts us the most, as mentioned, is the euro, just given the relative size of that in our business model. And as Benson mentioned, we've seen currency go up and we've seen it go down, and so some years we'll have a benefit, some years it could be a detriment. And our plan is to continue to build out that financial model with many different earnings drivers so that in those years where it looks like it's going to be a detriment, we've got some other opportunities to pull out of the bag to offset that currency impact. So that's how we're thinking about it. But largely, we try and control the pure economic risk, if you will.
Operator:
The next question comes from Matt Taylor from Barclays.
Matthew Taylor - Barclays Capital, Research Division:
I just wanted to clarify your comments on Asia because you talked about it a lot in the prepared comments. So I guess, can you kind of cast out the timing of what you expect here over the next few periods in terms of -- I guess, the biggest impacts are apparently China and Japan. You called that out as a major reason for being more conservative on 4Q guidance, so I guess I just wanted to understand how you've seen things changing either through third quarter or here, to-date, up to the call, and whether if there's anything to be concerned about there?
Benson F. Smith:
Yes, so actually, I would put it in the positive column, and here's why I think that -- we do not want to let our distributors get into a situation where they have bloated inventories. The way that most, at least, Chinese, distributors work and also in other parts of Asia, is they tend to make a commitment to buy a certain amount of inventory for a year period. That works well when the markets perform with their expectations. This year, I think, the overall markets are performing below what they thought the growth rate was going to be. And to the extent that, that's true, and to the extent that there is additional inventory in our distributors, we'd rather see that play through in the fourth quarter this year than go into 2015 with any extra inventory in those distributors. So -- and I think part of that is we're in a good position to be able to take care of that, and it's generally how we prefer to operate with our distributors. If there's any lack of clarity is, we don't always know exactly what their sell-through is but we're in the process of having conversations with our majors distributors now as they are contemplating what their fourth quarter orders are.
Matthew Taylor - Barclays Capital, Research Division:
Okay. And then on FX, I appreciate that nobody has a crystal ball, but you did call out about $0.08 to $0.10 in the fourth quarter. If things don't change much, is that about what you expect at least through the first few periods next year too?
Thomas E. Powell:
Well, you've got to look at the relative exchange rates in those quarters, so are you -- the $0.08 to $0.10 was relative to where we were in Q3, sequentially, where we're going to be in Q4. So you'd have to look at all the relative exchange rates for those quarters to make that assessment. And I just don't have that information readily available.
Matthew Taylor - Barclays Capital, Research Division:
Okay. Good. And then I guess for next year, can you talk a little bit about pricing, in general? So I know that there's going to be more direct-to-distributor conversions, maybe a little bit stronger new product cadence. But in general, how do you expect pricing to trend next year for the company as it's been, this year, a pretty good driver of continued growth?
Benson F. Smith:
I think, in very general terms, that we're likely to see next year what we're seeing this year.
Operator:
The next question comes from the line of Raj Denhoy from Jefferies.
Anthony Petrone - Jefferies LLC, Research Division:
Anthony for Raj here. Just a couple on APAC and then shift over to Vidacare and similar items. But in APAC, again, can you remind us how many distributors you have in the region? How many distributors you specifically have in Japan? And are there more opportunities in Japan to go direct over time into 2015? And how do think that would impact your business there?
Benson F. Smith:
So I think that the opportunity in Japan is largely going to be completed with the result of the current effort. We still use a layer of subdistributors in Japan and our intention is not to go beyond what I would sort of describe that master distributor, in Japan. So for the most part, Japan will be up and running as we anticipated, should be by the end of this year. China, we have a series of different distributors, some of that is the result of acquisitions that we've recently made. China has a very complex web of distributors, and depending on where in China you want to distribute, whether it's in that main core of hospitals or whether it's in more rural areas, we make different distribution decisions. So that's a little hard to answer and the fact is if we added up all our distributors we'd probably have hundreds of distributors in China that distribute Teleflex products. Our efforts right now in terms of inventory conversations is limited to the few large distributors that we have.
Anthony Petrone - Jefferies LLC, Research Division:
That's very helpful. And then maybe shifting over to Vidacare. Can you give us an idea of where the majority of growth is coming from when you look at the 3 products, Intraosseous, EZ-IO and OnControl? And then as we look out into 2015, what are the opportunities, specifically, across that portfolio, or is it more geographic expansion into other countries that will continue to benefit the Vidacare portfolio?
Benson F. Smith:
So first of all, the EZ-IO product is the Intraosseous product. So we really have 2 products, and both of them are doing extremely well and above our expectations. OnControl right now is a little bit more growth-centered in the U.S. EZ-IO, we're seeing growth in every geography where it's positioned. The opportunities over the next couple of years really relate to additional usage in difficult to stick patients, which we're getting increasing acceptance of from the clinician community. That principally relates to expanded use in hospital settings. We also are launching the product in Japan and in China and have approval in both of those countries to start launching it, so that -- there's certainly an element of geographic expansion to it. But I would say, we remain bullish for lots of reasons about the future for Vidacare over the next 5 years. We still see it as a growth product looking out that far.
Anthony Petrone - Jefferies LLC, Research Division:
Great. And the last one for me is, maybe just an update on the Intuitive alliance you announced a few quarters ago for the da Vinci Xi. I believe you're supplying trocars and ports, so is there anything on that front that you can provide an update on?
Benson F. Smith:
So I mean, really, our ability to grow that business is -- in that particular setting, has a lot to do with the acceptance of the Intuitive product. We're happy to see that, that is, I think, showing some improvement, and we value that partnership with them.
Operator:
The next question comes from the line of Matthew Mishan from KeyBanc.
Matthew Mishan - KeyBanc Capital Markets Inc., Research Division:
I think first for me is, I think last year you saw a budget flush in Europe at the end of the year. I'm just curious, what are you -- how you're looking at that this year? And are you baking in a tough comp there in the fourth quarter for Europe?
Benson F. Smith:
So it's a more typical pattern than an atypical pattern. Last year, we were concerned with a lot of emphasis to cut health care spending as a result of a weakened economy. We were concerned as to whether or not we'd actually see that typical pattern develop. This year, I would say, while there's certainly still some economic uncertainty in Europe, it hasn't translated into a lot of efforts to cut health care spending. So we are less concerned about that not happening this year than we were last year.
Matthew Mishan - KeyBanc Capital Markets Inc., Research Division:
Okay. And I apologize if I missed this, I missed the early part of the call, but I think you mentioned some one-off expense benefits that you didn't expect to recur. Just if you could, what were those and quantify them?
Thomas E. Powell:
Sure. Well I wouldn't say that there was anything significant in particular that we incurred, but we did pick up some benefits related to a fringe on insurance and some other miscellaneous costs, and collectively, they were a benefit during the quarter that we don't expect to reoccur. We also have some seasonality in the fourth quarter related to just how our various conferences are timed, so we've got some higher-level expense in the fourth quarter as a result of that. So I wouldn't be able to point to anything individually that's fairly significant. It was rather a collection of smaller items that had an impact positively in the third quarter, and likewise, we've got some seasonality in the fourth quarter that would shift the other direction.
Matthew Mishan - KeyBanc Capital Markets Inc., Research Division:
All right. And then just lastly, on the PICC side, you're able to make various claims against -- with antimicrobial, antithrombogenic, that Bard can't make now. I was just curious if you've been able to make some inroads there, if the competitive dynamics have kind of changed?
Benson F. Smith:
So our PICC line is one of our faster-growing product lines on a percentage basis. I think that both those issues, occlusion rates and infection rates, are becoming much more serious topics of conversation in hospitals for a variety of reasons, particularly now having to report those infection rates is driving that concern. So our PICC business was up 22% on a year-over-year comparison this quarter, and we expect that to continue to improve as we're able to marry that technology up with a built-in stylet to take advantage of our targeting position as well. So we're encouraged with our PICC progress.
Operator:
The next question comes from Chris Cooley from Stephens.
Christopher C. Cooley - Stephens Inc., Research Division:
Most of my questions have been addressed, but maybe just quickly, Benson, when you think about moving forward towards 2015, and I realize we're not giving guidance yet, and you look at where you're realizing the bulk of the growth from some of these acquisitions, and then, of course, the conversion, do you focus more on established businesses relative to maybe product lines that you had the opportunity to acquire in the past? I'm just trying to think about if there's any kind of change in the company's M&A strategy or acquisition strategy going forward. Because when you look at the growth in the quarter, admittedly, you did get a healthy 78 bps from new products, but the real driver here, of course, Vidacare and Mayo, and so I'm just trying to think about that as I look out into 2015 and beyond.
Benson F. Smith:
Yes, so in terms of our general acquisition strategy, Chris, it remains the same. We are interested in dealer-direct conversions, we still have an interest in late-stage technology acquisitions as a way to augment our internal R&D efforts. And when it comes to more major acquisitions like Vidacare and LMA, we're looking for those opportunities that first of all, provide us higher gross margins than our existing product lines so we can get a margin benefit from them. We're looking for products that have a higher growth rate than our existing organic growth rate and we're looking for products that we think we can really command a significant leading position in that product category
Operator:
The next question comes from Richard Newitter from Leerink Partners.
Ravi Misra - Leerink Swann LLC, Research Division:
This is Ravi actually in for Rich. Question regarding the commentary on the U.S. market, you noted some improvement. Just wondering what do you see going forward? Is there a potential for a potential acceleration here?
Benson F. Smith:
So I think I would still describe it as having some ambiguity. We're encouraged by some of the reports and conversations we're having with providers. A big part of their increase seems to be coming more from outpatient and emergency room visits than necessarily acute-care procedures. However, in those product lines that we have that are most affected by acute-care procedures, we saw some accelerating growth. So fourth quarter usually turns out to be a really important trend line for us. We should see a -- and normally see a pretty good pickup in activity in U.S. hospitals in the fourth quarter. So we're hopeful that, that's going to happen, but -- and it's one of the factors that we want to have a better understanding of as we put together our final plans for 2015.
Ravi Misra - Leerink Swann LLC, Research Division:
Great. And then one more. Just in terms of the fourth quarter. Are we looking at the same number of selling days or is there going to be 1 fewer or 1 more?
Benson F. Smith:
One more day.
Operator:
The next question comes from Matthew O'Brien from William Blair.
Matthew O'Brien - William Blair & Company L.L.C., Research Division:
Just to tease out the EPS commentary for Q4 a little bit, because I think that will be the focus of a lot of investors today. I think, Tom, you mentioned some additional dilution, specifically in Q4 associated with the convert and an additional spend most likely for Vidacare or some of the faster-growth higher-margin areas incrementally in Q4. Can you just quantify the impact? Is it a couple of pennies or even less than that?
Thomas E. Powell:
Well, as we look at the sequential shift, there's a couple of significant factors. So we've called out the FX impact of $0.08 to $0.10. Talked about tax in the range of $0.05. We think the share impact is $0.02. And as far as the incremental investments, we've got a number of programs put in the plan. Again, that's the same comment that we made earlier. We expect to spend it all, the question, if anything, is timing. And that's why the range in our guidance just depending on how much of that we actually get implemented during the fourth quarter. So I don't have a specific number on those additional investments that I'm be willing to quote.
Matthew O'Brien - William Blair & Company L.L.C., Research Division:
Sure. So just to understand it a little bit better. I mean the midpoint of the range I think is like $1.34, if you add back $0.09 for FX and maybe $0.02 to $0.03 for the shares. And then for some additional spend, we're talking about something closer to, organically, $1.46, $1.47. That seem like reasonable math?
Thomas E. Powell:
I couldn't argue with the math.
Matthew O'Brien - William Blair & Company L.L.C., Research Division:
Okay. And then just heading over to the M&A side of things. I know it's a big part of the strategy going forward. I'm sure the landscape is still pretty fruitful, but has anything changed on the valuation side of things just given how things are trending, generally speaking, within med tech land as far as some of the consolidation goes?
Benson F. Smith:
So I think the size and type and ownership of the kinds of properties we're looking at haven't been influenced much yet. I think also, I would just point out that we tend to go after targets where we're the most logical buyer and can usually offer more than certainly a private equity company or even another strategic company because we have quite a bit of natural synergy. So we haven't seen that trend as much in the size of companies we're looking at versus some of the other larger acquisitions, which might have additional tax benefits, et cetera.
Operator:
So you have no questions at this time. [Operator Instructions] No further questions. I would now like to turn the call over to Jake Elguicze for closing remarks.
Jake Elguicze:
Thanks, operator, and thanks, everyone, for joining us on the call this morning. This concludes the Teleflex Incorporated Third Quarter 2014 Earnings Conference Call. Have a good day.
Operator:
Thank you for joining today's conference. This concludes the presentation. You may now disconnect. Have a good day.
Executives:
Jake Elguicze - Treasurer & VP, IR Benson Smith - Chairman, President & CEO Thomas Powell - EVP & CFO
Analysts:
David Lewis - Morgan Stanley Kayla Crum - William Blair John Hsu - Raymond James Dave Turkaly - JMP Securities Matthew Taylor - Barclays Richard Newitter - Leerink Partners Matthew Mishan - KeyBanc Jason Wittes - Brean Capital Raj Denhoy - Jefferies
Operator:
Good day, ladies and gentlemen, and welcome to the Second Quarter 2014 Teleflex Incorporated Earnings Conference Call. My name is Nina, and I'll be your operator for today. At this time, all participants are in listen-only mode. We will conduct a question-and-answer session towards the end of this conference. (Operator Instructions). As a reminder this call is being recorded for replay purposes. I would like to turn the call over to Mr. Jake Elguicze, Treasurer and Vice President of Investor Relations. Please proceed, sir.
Jake Elguicze:
Good morning everyone, and welcome to the Teleflex Incorporated Second Quarter 2014 Earnings Conference Call. The press release and slides to accompany this call are available on our website at www.teleflex.com. As a reminder, this call will be available on our website and a replay will be available by dialing (888) 286-8010 or for international calls (617) 801-6888, passcode 18970797. Participating on today's call are Benson Smith, Chairman, President and Chief Executive Officer; and Thomas Powell, Executive Vice President and Chief Financial Officer. Benson and Tom will make brief prepared remarks, and then we'll open up the call to questions. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events, as outlined on Slide 4. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors made in our press release today, as well as our filing with the SEC, including our Form 10-K, which can be accessed on our website. With that, I'd like to now turn the call over to Benson.
Benson Smith:
Thanks, Jake, and good morning everyone. It's a pleasure to be with you once again and similar to prior calls I will start with an overview of the company results and then discuss some highlights. But even before I get into the details, I want to point out that as the management team we are quite pleased with the results we have been able to generate in the second quarter. In spite of somewhat anemic procedural trends in the U.S. and for us one less shipping day in the quarter, we were able to achieve significant revenue and EPS growth, we made good improvements in both gross and operating margins, and we improved our tax rate. All of which brings us much closer to achieving our longer-term financial goals by the end of 2015. In fact, our ability this quarter to reach gross margins above the 52% level is a key component in our ability to retain our 55% gross margin target exiting 2015. So we feel quite positive about our results. Now beginning with our second quarter highlights. Both the second quarter revenue and adjusted earnings per share exceeded our expectations. Revenue in the second quarter totaled $468.1 million. This represents an increase of 11.4% versus prior year on an as reported basis, and 10.1% versus the prior year on a constant currency basis. Our better than expected revenue performance in the second quarter resulted from several factors, including the over performance of both our Vidacare and Mayo acquisitions, our ability to continue to generate higher revenue from price increases, and improvement in the sales of existing products resulting from a slight improvement in end market utilization trends, primarily in Europe, and our as reported revenue benefited from foreign exchange favorability. Finally, I would point out that our year-over-year revenue growth is somewhat understated because of one less day in the quarter as compared to last year. We will make up that one additional day in the fourth quarter of this year. Turning to adjusted earnings per share. Second quarter 2014 adjusted EPS was $1.51. That compares to second quarter 2013 adjusted EPS of $1.27, or an increase of 18.9%. And well, Tom will cover this in more detail during his prepared remarks, the improvement in year-over-year adjusted earnings resulted from higher volumes, the continued ability to increase prices, and a favorable mix of higher gross margin sales. In addition, we continue to generate increased leverage to the income statement from non-revenue dependent items, such as lower adjusted tax rate when compared to the second quarter of 2013. These improvements were in spite of higher year-over-year operating expenses, resulting from the Vidacare and Mayo acquisitions. However, I will note that this increase in spending was planned and is one of the contributing factors to the over performance of both of these acquisitions. Moving on to our 2014 guidance. Based on the company's performance during the first six months of 2014, and our outlook for the remainder of the year, we are reaffirming our full year constant currency revenue growth guidance range of 7% to 9%. But are increasing our full year adjusted EPS guidance range from $5.35 to $5.55 per share to a range of $5.45 to $5.60 per share. Concerning our guidance, let me address two questions that may be on your minds. The first is, given our very strong revenue performance in the second quarter, why aren't we raising our full revenue guidance? And the second question is why aren't we raising our EPS guidance even more? Regarding our revenue guidance, our original projection was between 7% and 9% on a constant currency basis. We assume that we could safely get above the 7% figure, even if there was no uptick in procedures in the United States. Our expectation though was that, while we did not expect much improvement in the first half of the year in procedural rates, we thought we would likely see some improvement beginning to materialize in the second half of the year. That second half improvement was one of the factors we thought could drive us towards the higher end of our range. Our most recent conversations with U.S. providers leads to believe that we may not see much of an uptick in procedural rates in the second half of 2014. Our current estimate for our product lines is that procedures are somewhere between flat to down 1% compared to last year. For us though the good news is that our over performance in other areas will make up for this deficit more. However, without at least some improvement in U.S. procedures our view is that exceeding the top-end of our revenue guidance is likely a stretch. Now forecasting U.S. procedural rates still remains cloudy, and hence that's one of the reasons that's responsible for our conservatism. EPS is a little easier to forecast and therefore we feel more comfortable in raising our EPS guidance. However, as the year progress to the extent that we see ourselves trending towards the high-end of our new EPS range, we would likely increase spending against certain higher growth and higher margin products and regions. Vidacare and China standout as the most likely targets for increased investments, though not the only ones. Next, I would like to discuss second quarter pricing, volumes, GPO and IDN contract awards, and new product introductions in more detail. During the second quarter, the average selling prices of our products once again expanded when compared against the prior year. This past quarter, the improvement in the average selling prices of products contributed approximately 193 basis points of revenue growth and resulted from a combination of distributor-to-direct conversions, as well as core product price increases. From a segment perspective, we saw price increases, highest in Asia. And as expected, this was primarily due to the distributor conversions. This was followed by improvements in pricing we are able to generate in Europe, as well as those we are able to generate in our North American Surgical, Anesthesia/Respiratory, and Vascular Segments. These price increases were somewhat offset by a decline in the average selling prices of some of our OEM product offerings. Turning to sales of existing products, during the second quarter sales volumes of core products improved and contributed approximately 102 basis points of revenue growth. This growth is net of the impact of the one less shipping day in the second quarter of 2014 versus the second quarter of 2013. If you were normalize for that impact, sales volumes to core products would have increased approximately 200 basis points. This growth was stronger than initially expected and came primarily from our European and our OEM segments. Moving to new product introductions. During the second quarter, new products contributed approximately 73 basis points of revenue growth and this was below our original expectations. This was driven by a variety of factors. First, we are seeing longer regulatory approval times globally. Second, it is taking longer timeframes in order to get new products through hospital evaluation committees in the United States. Also, sales force time allocation, particularly in those divisions that are also selling the Vidacare product has resulted in less selling time against other new products. But because of the high margins and high growth rate associated with Vidacare, we have not been discouraging this shift in sales time allocation. But there is a tradeoff. Lastly, we took a conservative posture regarding commercial spending in the first half of the year. Shifting gears, the second quarter of 2014 saw continued expansion of contractual agreements between Teleflex and our GPO and IDN partners. In fact, during this past quarter, Teleflex won a total of 14 agreements. All of these awards were renewals of existing agreements and included product categories like central venous and dialysis catheters, laryngoscopes, and our LMA product offerings. Next, I would like to talk to you more detail about Vidacare. We continue to be quite pleased with the customer reception we have received to-date with respect to both the EZ-IO and OnControl product offerings. And during the second quarter, Vidacare contributed approximately $21.3 million of revenue and 5.1% or about half of Teleflex's constant currency revenue growth. If you were to compare these results to the second quarter of 2013, Vidacare's revenue increased approximately 30% on an as reported basis. And while, Vidacare revenue growth shows up as acquisition-related growth in 2014, if we were to maintain these types of growth rates next year, it would mean slightly more than 1% of additional organic revenue growth for Teleflex in 2015. We remain excited about the future potential of this product and consequently, we remained committed to growing the Vidacare business in the second half of 2014. And as I stated earlier, we plan to increase our commercial spending and clinical training expenditures to drive further revenue growth. Moving on, I would like to update you on a handful of recently received regulatory approvals and new product launches, beginning with the recent 510(k) approval, we received to market the ARROW-Clark VectorFlow Chronic Hemodialysis Catheter. Expanding our presence in the dialysis market continues to be a goal for Teleflex, and this product will be another step towards the attainment of that objective. This product features a symmetrical tip design that allows for ease of placement and sustained high flows with minimal recirculation. It's only catheter in the market with an innovative tip designed to produce a three-dimensional transition of blood entering and leaving the catheter. The next product I would like to bring to your attention is the LMA SureSeal PreCurved Laryngeal Mask. This product was developed from the asset that Teleflex gained in its acquisition of Ultimate Medical. We expect this product, which was recently launched in Europe to benefit the LMA portfolio by providing customers the option of a first-generation fixed curve device with a silicone cuff designed for ease of insertion and improved patient comfort. And finally, before I update you on the acquisition of Mayo Healthcare, the last new product that I would like to highlight for you is the ARROW GPS Balloon Dilatation Catheter. This product is for the Hotspur acquisition Teleflex completed in mid 2012 and combined angioplasty and targeted injection in one device for used in below the knee peripheral angioplasty procedures. The company recently received 510(k) clearance to market these catheters, and we believe that this product will enable clinicians to inject fluids, such as contrast media, while maintaining the guide wire position. Now, while we have released earlier version of Hotspur balloons, this particular release is much more important to us. It particularly teaches of a Hotspur targeted injection mechanism, are only relevant clinically when the lesion is quite far from the insertion site. In below the knee applications much longer length catheters are typically used. And so this should be an ideal application for the principal Hotspur VisioValve feature. We are in the midst of a limited market release in Europe in below the knee applications and so for the response has been quite favorable. We will similarly conduct a fairly extensive limited market release in the United State beginning later in the year. Turning to Mayo. This acquisition would provide high quality products education and technical services and customer support to healthcare institutions throughout Australia, was completed in February of this year. I'm pleased to report that the integration activities associated with the major distributor-to-direct conversion that Teleflex had planned to complete in 2014 remains on track. During the second quarter Mayo contributed approximately $9.4 million or 224 basis points of growth of Teleflex's constant currency revenue growth. Approximately half revenue growth came in the form of volume but the other half came in the form of price increases. And while we continue to expect Mayo to contribute meaningfully towards Teleflex's total constant currency revenue growth in both the third and the fourth quarters, I do want to point out that the June time period represent the financial year-end for most Australian based government hospitals. So toward the end of June those hospitals tend to spend whatever is left in the kitty. As a result Australia's revenue in the third quarter tends to dip when compared to the second quarter. This seasonal revenue performance somewhat mimics Europe, which will also typically has a softer third quarter primarily resulting from August vacations. However to-date the Mayo acquisition has exceeded our expectations and we expect that we will finish the year that way. That completes my prepared remarks. I would like to now turn the call over to Tom for him to provide you with a more detailed review of our second quarter financial performance and our 2014 outlook. Tom?
Thomas Powell:
Thanks, Benson, and good morning everyone. Let me start out by saying that I am pleased to report that Teleflex had a strong second quarter across a number of important metrics. Revenues exceeded our expectations, adjusted growth and operating margins expanded both sequentially and year-over-year, we reduced our adjusted tax rate, and adjusted earnings per share increased almost 19% from the prior year. Operating cash flows were strong. We took steps to strengthen our balance sheet and to delever. In aggregate we feel good about the progress made during this quarter and now let's move on to second quarter specifics. During the second quarter revenues were $468.1 million, which represents an increase of 10.1% on a constant currency basis. Approximately 7.9% of revenue was related to acquisitions and distributor-to-direct conversion, predominantly Vidacare and Mayo. The remaining 2.2% of revenue growth was organic in nature and was comprised of an increase in core product volumes, core product price increases, and revenues from new products. Somewhat limiting the growth was the fact that we had one less shipping day in the second quarter of 2014 as compared to the second quarter of 2013. We estimate that this negatively impacted our constant currency revenue growth by approximately 1%. If you were to normalize the impact of the one less shipping day and count the roughly $5 million of year-over-year revenue growth achieved by Vidacare, then organic revenue growth would be in the range of 4.5%. Turning to gross profit. For the second quarter adjusted gross profit was $245 million versus $209.2 million in the prior year quarter. Adjusted gross margin increased 254 basis points to 52.3%. The increase in adjusted gross margin was primarily due to product pricing, distributor-to-direct conversion, and the inclusion of Vidacare's high margin products into our portfolio. Further gross margin gains were limited by higher than anticipated manufacturing costs coming from a decision to delay the planned closing of a manufacturing facility and the deferral of select cost improvement programs. Turning next to adjusted operating margin. For the second quarter, the adjusted operating margin increased 109 basis points to 21%. The year-over-year improvement was the outcome of the gross margin gain, coupled with slightly lower R&D spending. So what's tampering the gains in operating margin are additional SG&A expenses associated with the Vidacare and Mayo businesses, increased product registration expenses to support our Asia growth strategy, and increased sales commission and bonus cost associated with the higher level of revenues. Moving next to our adjusted tax rate. For the second quarter of 2014, the adjusted tax rate declined 370 basis points from year ago level to 22.3%. The improvement in the adjusted tax rate stems from efficiencies realized to the integration of Vidacare and further optimization of our supply chain structure. On the bottom-line second quarter adjusted earnings per share increased 18.9% to $1.51. We have leveraged the growth in earnings to drive operating cash flow. For the first six months of 2014 cash flow from operations reached $120.2 million representing an increase of 114% versus the comparable period of 2013. The improvement in cash flow generation was largely due to the growth in earnings, improved working capital, and reduced pension contribution. Also during this quarter we took steps to further refine our capital structure and to delever. In April, the company integrated Vidacare into its legal entity structure. In connection with its integration we restructured our bond holdings which enabled us to efficiently repatriate $230 million of cash from our operations outside of the United States. Repatriated cash was then used to fund $235 million repayment of the outstanding principal amount of borrowings under our revolving credit facility. Then in May, we issued $250 million of senior unsecured notes. These notes bear interest at 5.25% and come due in 2024. We then used the proceeds to fund an additional $245 million repayment of borrowings under our revolving credit facility. Through these actions we were able to both reduce overall leverage and free up the revolver by turning out borrowings in an attractive 10-year rate. As a result, we will be better positioned to take advantage of future strategic opportunities. Finally, during the second quarter, we announced the manufacturing footprint rationalization plan intended to further improve the company's cost structure. Since we cover this in our last earnings call, I do not plan to revisit the details again, but will answer any questions later in the Q&A. And with that said, I will advise that we continue to make progress on this initiative and I have now provided notice to employees of two plans that were impacted by this restructuring decision. Next, let's turn to review of the segment operating results. Vascular North America revenue in the second quarter increased 13.5% to $64.2 million. The increase in Vascular revenue was largely due to the addition of Vidacare, new products, and price increases. Anesthesia Respiratory North America revenue decreased 5.7% to $55 million. The decline in Anesthesia Respiratory revenue was largely the result of the GPO contract that was lost in 2013 and an increase in back orders of select airway management products. We expect the negative impacts of the loss GPO award to moderately improve in the second half of the year. Partially offsetting this decline in the Anesthesia Respiratory volume was increase in the sales of new products and select price increases. Surgical North America revenue in the second quarter increased 1.3% to $38 million. The increase in surgical revenue was due to an increase in the average selling prices of products and new product introductions. These gains were partially offset by lower sales volume of existing products and it is our belief that the reduced volumes was primarily the result of one less shipping day during the second quarter versus the prior year. Moving to EMEA. Revenue in the second quarter was up 7.3% totaling $154.7 million. The increase in EMEA revenue was due to Vidacare product sales, higher sales volume of existing products, price increases, and the introduction of new products. Revenue in Asia increased 25.2% to $62.5 million during the second quarter. The increase in Asia revenue was due to the Vidacare and Mayo Healthcare acquisitions price increases, the introduction of new products, and higher sales volume of existing products. Similar to the first quarter, growth from China and Southeast Asia was particularly strong. Turning to OEM. Revenue in the second quarter increased 13.1% to $36.6 million. The increase in OEM revenue was due to higher sales volume of existing products in particular sutures and the introduction of new products. This was somewhat offset by a decline in average selling prices. And lastly, our other product revenue for the quarter was up 23%, totaling $57.1 million. The increase in other revenue was due to Vidacare sales that fall under our specialty business fall point. During second quarter the Latin America business, which also falls under our other segment, was flat year-over-year as strong results in Argentina were offset by softness in Venezuela and Brazil. Finally, I would like to provide you with an update regarding our full year 2014 financial outlook. With six months of 2014 now behind us, today we are reaffirming our previously provided 2014 outlook for constant currency revenue growth of between 7% and 9%. Consistent with our initial expectations approximately 75% of our projected 2014 constant currency growth will be sourced from a combination of the Vidacare acquisition and distributor-to-direct conversion. Remaining 25% of revenue growth will come from volume gains, new product introductions, and core product price increases. We are currently trending ahead of expectations for volume and pricing and trending a little bit behind on new product introductions. As a reminder, we expect that the majority of the 2014 pricing will come from distributor-to-direct conversions and that pure product price increases are expected to be much more selective than in past years. In terms of GAAP revenue growth expectations, we now expect revenue growth to be in a range of 7% to 9%. This is an increase from our original expectations which calls for GAAP revenue growth of 6% to 8%. As we began the year we anticipated that currency translation would cause a headwind of approximately 1%. However, largely due to the strength of the Euro relative to the U.S. Dollar, currency transformation turned out to be a tailwind rather than the expected headwind for that first half of the year. For the second half, we continue to anticipate that currency will be a headwind but now project a more neutral full year impact from currency. And now turning to adjusted gross margin. We continue to project adjusted gross margin to be in a range between 52% and 52.5% for the year. The projected 2014 gross margins represents an increase of approximately 240 to 290 basis points over 2013 and it's largely the result of the addition of Vidacare, distributor-to-direct conversion, and manufacturing operations efficiency programs. Moving on to adjusted operating margin. For the full year of 2014, we continue to expect adjusted operating margin, excluding intangible amortization expense to increase by approximately 100 basis points to a range of 20% to 21%. Further gains in adjusted operating margin are being tampered by investments to support the distributor-to-direct strategy and the addition of Vidacare. Moving on to taxes. As discussed earlier we remain on track to achieve a full year 2014 adjusted tax rate of 22.5% to 23.5%. Turning next to interest expense. Based on the capital structure now in place, our expectation is that we will achieve an adjusted weighted average interest rate of approximately 5.1% in the second half of 2014. This rate has modestly improved versus our prior expectations due to favorable market conditions allowing us to have priced the senior unsecured note offering more attractively than we had expected. Turning to shares outstanding. We continue to expect the adjusted weighted average share count to be approximately 44 million shares for full year 2014. And finally, on the bottom-line. Based on the company's performance during the first six months of 2014, and our outlook for the remainder of the year, we are increasing our full year adjusted earnings per share guidance range from the previous range of $5.35 to $5.55 per share to an updated range of $5.45 to $5.60 per share. And while we do not provide specifically quarterly financial guidance ranges, I will advise that our expectation is for third quarter revenues and adjusted earnings to be sequentially lower than results we achieved in the second quarter. There are few reasons that I can point to for the sequential revenue and earnings decline from Q2 to Q3. First, our historical experience indicates that there is a sequential decline in European product sales in the second to the third quarter. Given our large presence in Europe, this impact us a bit more than other medical device companies who do not have a significant presence there. Additionally, Mayo Healthcare had a particularly good second quarter resulting from the June year-end for government-owned hospitals in Australia. Also during the first half of the year we remain cautious in the level of investment spending, until we saw how utilizations and revenue played out. And given our strong overall revenues results, we are now more confident in our ability to further invest behind key growth initiatives. And finally, we are not anticipating foreign currency to contribute us positively in the third quarter as it did in the second quarter. In closing, we have gotten off to a solid start relative to our first half 2014 financial expectations. We are excited to be in a position of both increasing our 2014 financial guidance and having the financial flexibility to be able to invest behind some of our higher margin, high growth opportunities, such as Vidacare and China. We believe that these actions could help position us positively for 2015 and beyond. That concludes my prepared remarks and I will now turn the call back to the operator for questions. Operator?
Operator:
Thank you, sir. (Operator Instructions). Your first question comes from the line of David Lewis from Morgan Stanley. Please go ahead. Your line is open.
David Lewis - Morgan Stanley:
Benson, just two questions here. And congrats on a solid quarter. The first question is on organic growth. I think margins have been very good for several quarters. Organic growth has been the issue for most investors the last several quarters. This quarter clearly organic growth took somewhat of a step forward, and I think what's interesting is, when you consider Vidacare next year, you have some visibility back into that 3% to 5% organic growth range, may be with this quarter's 2% plus may be 1 point from Vidacare. So may be just kind of help us understand, after a couple quarters of difficult organic growth, how you're feeling about the organic growth set up for this business over the next three to four quarters as it relates to Vidacare impact, the core business in utilization, and may be some of the new products?
Benson Smith:
Yes. So I think the overall response I will give you David is we are certainly more positive about it now than we were even six months ago. We're still a little concerned about the absence of procedural uptick in the U.S. and that has the potential to add about an extra 100 to 200 basis points in organic growth rate. But even absent that, I think the numbers that Tom laid out for you, the way we're looking at this, we're probably in that 4% to 5% range when we count in the organic momentum for Vidacare, when we look at the absence of a shipping day. So we're a lot closer to that 5% even without the uptick in U.S. procedural rates that we think our portfolio is capable of. So I think the short answer is we feel certainly better about getting close to that number even in the absence of U.S. procedural growth but that would be a nice kicker on top of it.
David Lewis - Morgan Stanley:
Okay, very helpful. The second question is, obviously the debate in the stock is largely margin expansion. This particular quarter margins were good but you're obviously choosing to reinvest some of the upside away. May be just talk to us about where you are investing those dollars. Why should investors feel confident that based on that sort of reinvestment they are still going to see the type of margin and earnings upside in out years that they are expecting? Thank you.
Benson Smith:
Yes. So our six month experience with Vidacare leads to believe very strongly that the driving force behind that growth is the clinical education programs, which get users, accustomed to this device initially. And those take place in the form largely of cadaver labs and there is a very, very strong correlation to people going to one of those labs and returning back to their setting and starting to use the device much more frequently. So I think we've seen that very strong correlation and have a high level of confidence that that's really what's going to continue to drive Vidacare revenue. I think again relative to Vidacare, we've got some brand new markets that the product has been approved for recently. It's approved for sale in Japan; it's approved for sale in China. Those are really brand new opportunities for us. But again, we're going to require some investment in clinical education to actually get that product moving forward. We have been, I would say, overall extremely selective in looking at the kind of initiatives we want to support and are even aside from Vidacare looking at those kinds of activities that we've seen have demonstrated, relationship between spending in that area and increasing revenue.
David Lewis - Morgan Stanley:
Just for a follow-up on Vidacare and I'll jump back in queue, if there was any concern on Vidacare on your part it was the end market size for Vidacare, based on some of your comments today and, just frankly, based on the traction the last two quarters. Your views on the size of the market on Vidacare relative to now versus when you bought it, can you share with us either any qualitative or quantitative view on that?
Benson Smith:
So I think we're more confident now that there is a substantial international market as we've gotten a certainly preliminary feedback from key users in China and Japan, in Europe. So I think that's been a positive to us. I think we also have been quite pleased with the adoption rate or the OnControl device in the oncology segment, which had only started to receive some attention from the Vidacare's sales force in the last year that they owned the product. And we're seeing some pretty good traction in the military segment as well. So all those things I think have bolstered our view about the potential performance of this product, above certainly what we had in our acquisition model.
David Lewis - Morgan Stanley:
Okay. Thank you.
Operator:
Thank you. Your --
Jake Elguicze:
David, this is Jake. Just real quick. Just to add on to your question here. I also think that these investments that we're talking about accelerating into 2014, a lot of these were already planned for from our standpoint in 2015. And we're simply taking the opportunity potentially to invest a little bit earlier. And we're still maintaining our 2014 adjusted operating margin range of between 20% to 21%. So I don't think simply by making some additional investments in 2014 that that takes away from our -- any of our prior thoughts related to margin expansion and where we think we could end up 2015.
David Lewis - Morgan Stanley:
Great, thanks for that clarity.
Operator:
Okay, thank you. Your next question comes from the line of Matthew O'Brien from William Blair. Please go ahead. Your line is open.
Kayla Crum - William Blair:
Hi, guys, this is Kayla in for Matt. Thanks for taking our questions. Just wanted to start off trying to get a sense for the sustainable growth profiles of your required assets. Anesthesia was a bit softer than what we were looking for. And, so, just wanted to see where LMA is within its trajectory. And then, I know you touched on this a bit, but how you view Vidacare as a contributor over the next several years, as well.
Benson Smith:
So I think that the softness in anesthesia is somewhat particularized to the U.S. and relates I would say primarily to just soft procedural rates in the United States. So those are the particularly LMA, the LMA portion that is used in general anesthesia. If those procedural rates are down we have a very large share of the U.S. market. So we tend to feel of that that way. Overall, LMA companywide experienced approximately 3.1% growth rate this year. So except for the United States we're seeing that product perform as expected. And again, we have some -- we think we have a very good couple of new products that will come along. One is just been released that I referenced in my remarks. And we have another product that should be on the marketplace in the early part of 2015. So our long-term view of LMA, given some adjustment in U.S. rates, is in that 4.5% to 5% growth potential range. Vidacare, every time we think we've quantified what we think the opportunity is, we see some blue sky opportunities on top of that. So I think I'll just reiterate what I said today. We certainly feel more bullish about it than when we bought it. And we are anxious to see the extent and the speed at which we're able to get some adoption with some additional spending against the clinical education.
Kayla Crum - William Blair:
Okay, great. And, then, you've done a number of late-stage technology acquisitions over the last couple of years. Can you just help us get a sense for when those assets will begin to contribute on the top-line more substantially?
Benson Smith:
Hotspur was one of those late-stage acquisitions. We have kind of been waiting for that product to get its way to the marketplace, for below the knee applications. We don't expect it to meaningfully contribute in 2014, because we will just be largely confined to limited market releases in the U.S. in the last part of the year. We do expect that to start to show some revenue growth in 2015. The other, certainly the largest inventions we've made to-date in the late-stage technology arena is in Semprus. We experienced some technical difficulties in attaching the polymer to various substrates. That issue seems to be resolved at this point in time and so we are in the later stages of doing some testing, particular testing around specific product categories and we should start to see those creep into the marketplace in the latter half of 2015.
Operator:
Thank you. Your next question comes from the line of John Hsu from Raymond James. Please go ahead. Your line is open.
John Hsu - Raymond James:
Good morning. Hi, this is John in for Larry.
Benson Smith:
Good morning.
Thomas Powell:
Good morning, John.
John Hsu - Raymond James:
Good morning. Just had a quick question as given consolidation in M&A in the space, and we really believe that scale is becoming more important, just I guess going forward help us think about how you're thinking about that may be from an M&A perspective. And just more broadly your capital allocation plans as well. Thank you.
Benson Smith:
So just addressing the scale issue, I think you're right in that, in your assessment that scale is becoming increasingly important. There is a size at which it becomes less important though and I would say that if you're not big enough to be able to walk into GPOs on a pre-frequent basis in the United States, if you're not big enough to have a real global distribution of your product line, it's hard to compete against those companies that had that size. Well we are certainly smaller in comparison to -- obviously other medical device companies; we are actually big enough that we meet that criteria. We have frequent visits and/or certainly well known to GPOs and IDNs in the U.S. We have a good capability to be able to sell a product in every significant market globally. So I actually think the size we're at is an advantage rather than a disadvantage. It's an entirely different matter if you're $100 million company and really only able to sell the product in one market. I do think from our -- therefore our acquisitions strategy is really driven around products that particularly strengthen our franchise rather than simply trying to get bigger for the sake of being bigger. And so again I think what you've seen in the past remarks, which is acquisitions in the size of Vidacare and LMA provided they meet our criteria, some investment, some continued investment in late-stage technology acquisitions, some continued investment in distributor acquisitions is what you can expect I think over the next three years for sure. So we don't see our thoughts about acquisition changing much over what we've done over the last couple of years.
Operator:
Thank you. If we can move on to the next question which comes from the line of Dave Turkaly from JMP Securities. Thank you. Please go ahead.
Dave Turkaly - JMP Securities:
Thanks. I guess it's nice to hear somebody talking about end markets in Europe ticking up a little bit. I was wondering if you could give us a little color. Is that kind of across the board? Or anywhere you'd highlight as sort of being a little better from a utilization standpoint.
Benson Smith:
So I would generally describe it as across the board. I think we're seeing a little bit better results out of Italy and Germany. If you get down to some product lines we are certainly seeing good results in the UK. France has probably been one of the areas that's been a little more sluggish to come back but overall it's good throughout the continent.
Dave Turkaly - JMP Securities:
And could you just remind us of the mix of Vidacare geographically, when you purchased it?
Benson Smith:
Yes, about 75% of the revenue was in the U.S. and about 25% of it was outside the U.S. The majority of that outside the U.S. revenue was in Europe, very little contribution from Asia.
Dave Turkaly - JMP Securities:
Thank you. And then last, $867 million in net debt. Can you remind us what your covenants are, like whatever turn rate you can -- how levered you can get at this point?
Thomas Powell:
Well in terms of our covenant we can go up to four times. What we talked about in the past is that we're comfortable with a longer-term three times leverage we take it up to three-and-a-half times for the right acquisition opportunity, if we had a pathway back that three time level.
Dave Turkaly - JMP Securities:
And where are you sitting today?
Thomas Powell:
We're about 2 --
Benson Smith:
2.8.
Thomas Powell:
2.8.
Operator:
Thank you, sir. Your next question comes from the line of Matthew Taylor from Barclays. Please proceed.
Matthew Taylor - Barclays:
Hi thanks for taking the question. Can you hear me okay?
Benson Smith:
You bet, Matt.
Matthew Taylor - Barclays:
Great. So just wanted to ask a couple questions here. You mentioned China as a key growth opportunity, and you've talked about that in the past. Can you just give us an update on where you are in China in terms of the contribution today, and how much investment in growth we could see out of that over the next year or so?
Benson Smith:
Yes, so right now I think our sense is that we continue to need to add sales heads in Japan as we rollout our additional product lines into Japan. We're making some other investments in Japan also over the next year just in terms of our presence there in other capabilities. Our overall Asia sales usually amounts to around 12% of our revenue and China accounts for about 5%.
Matthew Taylor - Barclays:
Okay. And then just on the gross margin performance this quarter, you talked about several components. Can you just break down the contributions from acquisitions distributor-to-direct and cost reduction?
Thomas Powell:
Sure. I can walk you through that. So on an adjusted basis we talked about our gross margin improving 250 basis points during the quarter. As we look at the components of that there is largely four pieces to highlight. The first is Vidacare with the addition of their 85% gross margin products contributed about 180 basis points to that growth. Then go-direct, which is showing up in the form of pricing and driving gross margin largely coming from our Mayo acquisition South Africa and LMA distributor-go-direct as well, now that contributed about 90 basis points. Now we also picked up another 10 or so basis points from the introduction of new products, which carry a higher margin in the average. We did have some operation performance downsize during the quarter and that was due to a cautious decision to delay the close and move of manufacturing sites for a period of time. And so essentially what we got is some redundant costs at both the receiving site and the defending site. And then we also made the decision to defer some select manufacturing equipment programs that kind of held us back some additional gain and we will pick that up as we move forward. But overall as we look at all the cost improvement program that we've got scheduled for the year, are largely tracking to a full year number. So we feel good about it where we stand in the aggregate for the year.
Matthew Taylor - Barclays:
And just to follow-up on that, strategically you seem to be in a pretty good spot in your ability to continue to increase gross margins. You referenced having confidence in that 55% goal earlier on the call. And I was just curious, as you get some improvements here in the gross margins from things like price and new products, does that change how you think about the pace of restructuring, or whether to restructure at all, in some instances? I'm just curious how you're looking at it over a longer-term period in terms of your ability to move manufacturing to lower-cost jurisdictions or consolidate some of that stuff?
Benson Smith:
So I think the best way to characterize that is to the extent that we see some over performance in our non-restructuring efforts that's just going to help us in our overall activity to continue to increase our gross margins. We don't see that as having an impact on our current thought process around the overall restructuring efforts. We've certainly indicated, I think on many occasions, that we see ourselves over the next several years with a capability to move beyond that 55% number. And so the combination of all those things is actually just is very helpful in our ability to be able to do that.
Operator:
Thank you. Your next question comes from the line of Richard Newitter from Leerink Partners. Please precede sir.
Richard Newitter - Leerink Partners:
Hi, thanks, guys. Thanks for taking the questions. I was just hoping you could comment. It looks like once again your North America Surgical business saw good traction. And that's an area, I think, consistently, with last kind of where you think the portfolio's a little bit under-appreciated. You always seem to point to some of the products in Surgical. Could you just give us a reminder a highlight of the products there that are gaining momentum, where you feel incrementally more confident?
Benson Smith:
So we have -- we continue to see good utilization of our polymer clip ligation product line. I think as we look and that's true in the U.S. and true globally. We actually see occasional strength in our reusable instrument line as hospitals go through different sort of periods of buying instruments. I think as we look over the next several years, we are expecting one of the lead product entries to be in this micro laparoscopic areas. The feedback that we are getting from key opinion leaders now and this is quite favorable that will take us really to 2015, to the end of 2015 by the time we start to see that start to take off in a measureable way. I think there's other product EFX continues to perform well. So generally that the good part about out that is I think we've made some great investments and have an opportunity to really propel that to above average growth rates if there is a negative that's one of the product areas that gets caught up in the procedural downturns particularly in the U.S.
Richard Newitter - Leerink Partners:
Okay. And then just how do we think about surgical and how it falls within the margin contribution or mix shift, surgical to numbers?
Benson Smith:
Good. It's well above our average from a gross margin standpoint of view.
Richard Newitter - Leerink Partners:
Okay. So, as that continues to maybe outperform some of the other businesses, that's a positive mix shift driver, clearly?
Benson Smith:
Correct.
Richard Newitter - Leerink Partners:
Got it. And then, just lastly, on price, it sounds like price got a little bit better this quarter. Can you just remind me, when you refer to price you're just talking, you're not including any mix shift benefits. That's your kind of new product contribution section. Is that correct?
Benson Smith:
Correct.
Richard Newitter - Leerink Partners:
So -- okay, got it. So, price improved a little bit, It seems like you feel a little less confident in potentially kind of mix contribution going forward. How long do you think that lasts? How long are the -- how elongated is the approval process getting to impact this? And to the extent that you had an assumption heading into the year, what do you think the delta is? Bridge me to your new outlook with that kind of slightly eroded contribution.
Benson Smith:
I'm not sure I completely understand the question so if I don't answer it feel free to ask it again. I think actually we're quite positive in terms of seeing our gross margin mix continue to improve and we are again allocating sales time continually against our higher margin growth opportunity. So our expectation is we will continue to get some benefit from that. Relative to pricing it was better than we expected on both fronts. We're getting a bit, a more growth out of the distributor-to-direct conversions than we thought but we're also getting some better pricing out of our core pricing than we expected. So I don't think it was our intention to signal that we expect some decline about that and actually we're pretty pleased with our continued efforts to get some price out of the marketplace.
Richard Newitter - Leerink Partners:
Sorry, I just I thought I heard pricing got a little bit better, but perhaps new product contribution, the outlook is slightly a touch more conservative or cautious because you're seeing it a little bit tougher to get new products approved. So, I was just trying to figure out what maybe the puts and takes were with respect to the underlying price and mix contribution going forward. It sounds like core pricing a little better than expected. As well, you're seeing some incremental price improvement due to distributor conversions, which may be offsets, whatever, slight elongated timeline for approval might impact your ability to get new products and mix shift into the market.
Benson Smith:
So the way we look at new products kind of from two perspectives. One is the overall contribution. And then, there are I would say just in our industry it's not unusual for the FDA to take a little longer than might have been in our original plan to get a new product on the market had we gone back a year earlier for example we would have expected this Hotspur Balloon to be on the market sooner than we anticipated or sooner what actually happened. I think the way we actually measure the success of a new product after it's released is how close is it doing to our expectation from the time it's released. There is a bit of an issue in the U.S. I would say relative to something that cost a hospital more the process to get it through the hospital channel is a bit more complex. Those committees cannot meet in the summer time. So that can have an impact and almost everything now has to go through some kind of hospital product evaluation. So that's having certainly an effect but I don't think we see that as a long-term issue. It's just going to take a little longer to get the ball rolling in some of these activities but we're still pretty confident about our new product lineup.
Richard Newitter - Leerink Partners:
Got it, so just may be delay, nothing structural.
Benson Smith:
Correct.
Operator:
Thank you, sir. Your next question comes from the line of Matthew Mishan from KeyBanc.
Matthew Mishan - KeyBanc:
Great, thanks for taking my questions. Maybe I missed it but did you update your Vidacare expectations for this year?
Thomas Powell:
We haven't specifically but as we spoke through the results of the quarter, I picked up on the fact that Vidacare is about $21 million in revenue. As we started the year we had estimated revenue in the range of $68 million to $72 million for Vidacare. Now based on a first quarter result of that $20 million -- $21 million of second quarter which was a bit strong due to a large military order which hope we would rather keep but not actually discount on. And we would expect that we're probably in that $20 million range for each of the third and fourth quarters. So we're trending towards the $80 million range for the year on revenue.
Matthew Mishan - KeyBanc:
Now what about the --?
Thomas Powell:
Obviously a positive story given the high gross margins associated with the product.
Matthew Mishan - KeyBanc:
What about the EPS accretion? I think you also said $0.10 to $0.15 for this year. Is that a little bit higher now, too?
Thomas Powell:
Yes, it would also trend higher just given the higher level of revenue.
Matthew Mishan - KeyBanc:
All right. And on the R&D expense as a percentage of sales that seems to be backing off a bit. How should we be modeling that going forward?
Thomas Powell:
As we think about the year we are down a bit in R&D. We touched on the fact that if we -- as we began the year we are somewhat cautious in the level of investments. I think you should think about in R&D in particular is that we did pulled off a little bit on some of the R&D spending associated with Semprus. We worked through some of the technology challenges. As Benson mentioned, we are feeling more and more confident about that and expect to resume spending against that project. So we look to see our R&D spending ramp up throughout the back half of the year as a percentage of revenues. We're down at the 3.2% range on adjusted basis in Q1 and Q2, and we expect that to get above 3.5% for Q3 and Q4. And certainly as we think about R&D we think about also the spending from expense standpoint. Also the investments we're making to buy this late-stage technology acquisitions. So well the R&D spending is kind of at a 3% plus range, we've also got some investments we've made and acquisitions such as Semprus or Hotspur.
Matthew Mishan - KeyBanc:
Okay, great. And just last question for me -- you indicated that the repatriation gives you kind of the flexibility to do another acquisition. I was just curious about your willingness to do another deal given everything on your plate and what the pipeline looks like.
Benson Smith:
So certainly our willingness to do a deal is there. We do have very type criteria that we are quite disciplined in staying within. Like those products that are largely or companies that are largely single product focused, like those companies that have a product that we think we can take globally. We like those products that obviously have higher growth rates associated within him and higher margins in our current portfolio. So we're not anxious to do a deal just to do a deal. We're pretty tightly disciplined around that. I think the -- I would characterize the pipeline today assuming to what it was a year or two ago and again gets back to my point about size. Those companies that are in that $50 million to $200 million range in revenue have a harder time just being able to go global without incurring a lot of expenses. They have a harder time walking into GPOs and getting their products on contracts. So that still seems to be a pretty good inflexion point where particularly companies that are ventured-back are willing to look for an alternative.
Operator:
Our next question will come from Jason Wittes from Brean Capital. Please go ahead. Your line is open.
Jason Wittes - Brean Capital:
Hi there. Thanks for taking the questions. Solid quarter, and gross margins, in particular, appear way ahead of schedule, 52.3%. I think from your commentary earlier the assumption is that you'll continue to see improvements this year. But also, with the previously announced plan consolidation, I believe there's something in the nature of 180 to 200 basis points of an addition improvement, which we'll likely see next year which, if my math is correct, means you're very close to getting to your 55% gross margin goal by the end of next year. Is that the right way to think about it?
Benson Smith:
Correct. And that's, I think that's one of the reasons why we're quite pleased we're able to break over that 52% number. We really need to be there for the manufacturing efficiencies to kick in enough to get us over that 55% number by the end of the year. So we were pleased and I think we would have been pleased had it happened any time this year but sooner is always better than later.
Jason Wittes - Brean Capital:
Right. I guess the assumption is, though, you will continue to see those improvements. And also that the plant closures or plant consolidation impact really won't be felt until next year, so that's we should be adding that to next year's assumption.
Benson Smith:
So the plant closures on our current plan starts to make a contribution towards the end of 2015 so that's correct.
Jason Wittes - Brean Capital:
Okay.
Benson Smith:
We're not going seeing much of a linear jump though between that 52.5% to 55%. The majority of that jump comes from the footprint consolidation. So I don't want to give the impression that we're going to see sequential quarter-to-quarter improvement and it's going to be a gradual ramp up to 55. It's going to be relatively what's more like a bullish jump as that starts to kick in.
Jason Wittes - Brean Capital:
And that will be in the third or fourth quarter of next year roughly?
Benson Smith:
That's as close as we've pinned it, publicly yes.
Jason Wittes - Brean Capital:
Okay, fair enough, very helpful.
Thomas Powell:
Just to clarify in this year to make sure we got expectation I did say that we would continue to improve what, what we're thinking about in terms of first market balance of the year. We look to see that continue to strengthen in the third quarter and then in the fourth quarter we're going to have some expenses associated with the footprint consolidation that won't be adjusted out for calculating adjusted gross margins. So that will impact the gain a bit as we go through the fourth quarter. And then just to clarify on the overall footprint project, what we talked about during the last quarter's call was that we expected to realize savings in total once fully implemented of $28 million to $35 million. And those savings would begin in 2015. So we start realizing those in the end of 2015 and then, that's going, in addition to some other actions we've got some cost saving projects will allow us to get to 55%. But then the majority of the savings from footprint really kick in, in 2016. So we're feeling confident that we can get towards the end of 2015 the 55% and then have additional benefit from footprint thereafter.
Jason Wittes - Brean Capital:
Okay, very helpful. Encouraging, as well.
Benson Smith:
I'm going to use this occasion though just to issue caveat that we have issuing all along and that is, if there is a risk associated with the footprint consolidation and there is a risk. The risk really has to do with timing. And we may find ourselves in a situation where because of unanticipated orders, other factors, we may need to keep a particular facility open little longer than what our plan was so that could delay the timing of getting some of these savings. And to us we're always going to err on the side of making sure we have product supply as opposed to trying to hit an arbitrary deadline. That being said, we think we've got enough contingencies to be have crossover that 55 number by the time we exit 2015. There is a risk; it could be pushed into the early part of 2016.
Jason Wittes - Brean Capital:
Okay, fair enough. And then also wanted to just revisit your guidance commentary. Just to be clear, you're not assuming any type of volume improvements in the U.S. in the upper end of that range? Or does that have some expectation there of volume improvements?
Benson Smith:
Correct. We're assuming that trend we've seen for the first half of the year continues for the balance of the year. We hope we're wrong and we do see an impact but we're not counting on it in our guidance.
Jason Wittes - Brean Capital:
Okay. And then Vidacare is obviously doing quite well. Quite a few questions on it. I have one more. And that is, first off, it sounds to me like you think, in terms of the growth rate, you kind of implied 30%, seems to be somewhat of a sustainable growth rate, at least into next year. And if I look at -- if we think about the breakout of that number, how much of that is U.S. driven versus OUS driven?
Benson Smith:
So the big investments that we're going to make this year, in places like China and Japan, are not actually likely to derive significant revenue in 2015. But if we don't start the process now we're not going to see them in 2016. So most of our growth in 2015 is likely to come from continued expansion in the acute care setting in hospitals, continued adoption in for the oncology product throughout the U.S. And then, in Europe it's a bit more broader base. We still have significant opportunities in the ambulance segment in Europe and then moving into the hospital segment. I would say though that as we are speaking about Vidacare's growth next year, we're not necessarily thinking it's going to grow by 30% this year over last year. We think that the -- perhaps a better way to look at it is, the dollarized growth is going to look similar in term of an increase this year or last year and that's where sort of what we were tying it to the 1% of our organic growth rate.
Operator:
Thank you, sir. Your next question comes from the line of Raj Denhoy from Jefferies. Please proceed.
Raj Denhoy - Jefferies:
Hi, good morning. I was curious if I could just ask about the distributor-to-direct conversion in the quarter. I think you noted, of the 193 basis points in price, that that was probably a big factor of that. I mean it also sounds like it might have bled a little bit into the acquired revenue number. So I'm, one, trying to figure out how much that actually contributed in the quarter all-in. And then my second question is, as you look forward from here, what's the prospects for additional distributor conversions over the next several quarters?
Benson Smith:
So certainly, the acquisition of Mayo was our biggest by far planned distributor conversion for 2014. We are in a series of ongoing discussions and we always are with additional distributors. At this point, it's unlikely that something would happen in 2014 in a way that would significantly drive revenue because we would only have month or so at best of revenue contribution in 2014. The specific question about Mayo was in the $9.1 million.
Thomas Powell:
$9.4 million
Benson Smith:
$9.4 million range about half of that was driven by our increased prices to end users versus selling to distributor and about half of that came from volume.
Raj Denhoy - Jefferies:
Okay. But I guess is there -- I know that you probably won't find one of that scale perhaps -- but is this a part of the plan, in a sense, going forward to find additional of these distributors or other? Because it does add nicely to your revenue growth and your pricing obviously. But is there other possibilities to do these?
Benson Smith:
The answer to that Raj is yes. And actually every time we do an acquisition like Vidacare or like LMA they typically have distributors in areas where we can easily sell the product on a direct basis. And so that process in and itself ease us with a continuous supply of opportunities to overtime take that business direct. And you're right, it does have a great impact on our margin, gets as closest to the customer. We are enthusiastic about that activity.
Raj Denhoy - Jefferies:
Okay. And maybe I could ask one, a bit of a segue to your previous question. You talked about the caveat in terms of pushing out some of the plant closures. In this quarter you did note that you decided to delay a plant closure, and also, I think, deferred some of your cost improvement programs. And I'm curious how to think about that. Was there something in particular in the quarter that you saw that you thought perhaps we shouldn't do this so soon? Or is there anything we should look at and think perhaps maybe you're less committed to that over the near term? Any thoughts would be helpful, really.
Benson Smith:
Well, so this the particular circumstance that Tom referenced actually related to a move that was separate and apart from our restructuring program. It was an effort that was initiated last year. And as sometimes happen, demand for product exceeds what you might think it's going to be and we therefore had to renegotiate additional lease time in a facility, longer than what we had planned. And so now we have to add those or really take into account those costs. I would say that those kinds of circumstance are always probabilities in a move like this. And I'll go back to my remarks that we're always going to err in the side of making sure we have a good customer supply as opposed to try and economize in areas that might hurt us in these moves. But it certainly doesn't discourage us at all from the overall initiation of additional cost improvement programs.
Operator:
Thank you, sir. We have no questions at this time. (Operator Instructions). There are no questions coming through. I would now like to turn the call over to Mr. Jake Elguicze for closing remarks.
Jake Elguicze:
Thanks, Operator. And thanks to everyone that joined the call today. This concludes the Teleflex Incorporated second quarter 2014 earnings conference call.
Operator:
Thank you, sir. Thank you for your participation in today's conference. This concludes the presentation. You may now disconnect. Good day.
Executives:
Jake Elguicze - Vice President of Investor Relations and Treasurer Benson F. Smith - Chairman, Chief Executive Officer, President and Member of Non-Executive Equity Awards Committee Thomas E. Powell - Chief Financial Officer, Principal Accounting Officer and Executive Vice President
Analysts:
David R. Lewis - Morgan Stanley, Research Division David L. Turkaly - JMP Securities LLC, Research Division Lawrence S. Keusch - Raymond James & Associates, Inc., Research Division Jason Wittes - Brean Capital LLC, Research Division Matthew Taylor - Barclays Capital, Research Division Matthew Mishan - KeyBanc Capital Markets Inc., Research Division Kaila Krum Korosh Saba - Stephens Inc., Research Division Richard Newitter - Leerink Swann LLC, Research Division Anthony Petrone - Jefferies LLC, Research Division
Operator:
Good day, ladies and gentlemen, and welcome to the Q1 2014 Teleflex Incorporated Earnings Conference Call. My name is Steve, and I'll be your operator for today. [Operator Instructions] And now, I would like to turn the call over to Jake Elguicze, Treasurer and Vice President of Investor Relations. Please proceed, sir.
Jake Elguicze:
Thank you, and good morning, everyone, and welcome to the Teleflex Incorporated First Quarter 2014 Earnings Conference Call. The press release and slides to accompany this call are available on our website at www.teleflex.com. And as a reminder, this call will be available on our website and a replay will be available by dialing (888) 286-8010 or for international calls (617) 801-6888, passcode 11286884. Participating on today's call are
Benson F. Smith:
Thanks, Jake, and good morning, everyone. It's a pleasure to be with you once again. And similar to other calls, I'll begin with an overview of the company's results and discuss some highlights. So to begin with, I'm happy to advise you that both first quarter revenue and first quarter adjusted earnings per share exceeded our expectations. Revenue in the first quarter totaled $438.5 million. This represents an increase of 6.5% versus the prior year on an as-reported basis and 6% versus the prior year on a constant currency basis. The better-than-expected as-reported revenue performance in the quarter versus our initial expectations resulted from foreign exchange favorability, as well as from the overperformance of both our recently completed Mayo and Vidacare acquisitions. As you may recall, when we last provided an update in February, we indicated that we expected core volumes could be soft in the first quarter as a result of uncertainty associated with the implementation of the Affordable Care Act, as well as certain other circumstances unique to Teleflex. As such, Teleflex planned its 2014 revenue cadence in a more cautious manner than in 2013. With the first quarter now behind us, I'm pleased to say that this appears to have been a prudent thing to do as the combined impact of volume, new product introductions and pricing was in line with our initial expectations. When comparing first quarter to results for the prior year period, our constant currency revenue growth was largely due to the contributions of Vidacare and Mayo, as well as the introduction of new products to the market and an improvement in the average selling prices of products as compared to the prior year period. We do expect our non-Vidacare volume to continue to ramp up during the remaining 3 quarters. Turning to adjusted earnings per share. First quarter 2014 adjusted EPS was $1.22. That compares to first quarter 2013 adjusted earnings per share of $1.06 or an increase of 15.1% versus the prior year period. And while Tom will cover this in more detail during his prepared remarks, the improvement in year-over-year adjusted earnings resulted from higher revenues at higher gross margins, as well as lower adjusted tax rate when compared to the first quarter of 2013. This was somewhat offset by higher year-over-year operating expenses. In summary, Teleflex's performance in the first quarter supports our belief that the company remains on target to achieve our previously provided 2014 constant currency revenue growth and adjusted earnings per share guidance ranges. Next, I would like to discuss first quarter pricing, GPO and IDN contracts and new product introductions in more detail. During the first quarter, the average selling prices of our products once again expanded when compared against the prior year. This past quarter, the improvement in the average selling prices of products contributed approximately 108 basis points of revenue growth. The price increases that the company achieved in the first quarter were evenly divided and came from a combination of distributor-to-direct conversions and core product price increases. From a segment perspective, we saw price increases highest in Asia, primarily due to distributor conversions. This was followed by improvements in pricing we were able to generate in Europe and in North America with respect to our Anesthesia/Respiratory and Surgical segments. These price increases were somewhat offset by a decline in the average selling prices of some of our OEM product offerings. Moving to a new product introductions. During the first quarter, new products contributed approximately 78 basis points of revenue growth. The contribution from new product revenue during the quarter was in line with our original expectations, but we do expect contributions from new product revenue to uptick during the remaining 3 quarters. Turning to new products by segment. New product revenue growth was largest in our Vascular segment, thanks to our ArrowADVANTAGE5 PICC product that is now preloaded for our VPS device. This was followed by new product contributions coming from our Anesthesia and Respiratory segment due to our ISO-Gard Mask with Clearair Technology. Finally, the company had additional new product revenue growth stemming from Europe, thanks to the additional PICC product offerings and from North American Surgical segment due to an additional WECK EFx product sales. Shifting gears, the first quarter of 2014 saw a continued expansion of contractual agreements between Teleflex and our GPO and IDN partners. In fact, during this past quarter, Teleflex won a total of 17 agreements. Five of those awards were new and included product categories like pain management, intra-aortic balloon pumps and catheters, arterial catheters and our VasoNova product offering. Next, I would like to talk to you in more detail about Vidacare. We've been extremely pleased with the customer reception we have received to date with respect to both the EZ-IO and the OnControl product offerings. Integration activities remain on schedule. And during its first full quarter as part of Teleflex, Vidacare contributed approximately $20.2 million of revenue. This was slightly higher than our initial expectations and was in part due to sales to the military, which can be difficult to predict. In total, Vidacare contributed approximately 4.9% to Teleflex's constant currency revenue growth in the quarter. Maybe even more importantly, on an as-reported basis, Vidacare revenue grew approximately 24% versus the first 3 months of 2013. And while Vidacare's revenue growth shows up as acquisition-related growth in 2014, if we're to maintain these types of growth rates next year, it would mean slightly more than 1% of additional core revenue growth for Teleflex in 2015. We are committed to growing the Vidacare business and are taking steps this year to invest in additional clinical training and cadaver lab workshops to drive that further revenue growth. As a result of the excellent reception, we are redirecting existing sales and marketing resources towards the sales of Vidacare products. This reallocation of resources may allow us to exceed our expectations for Vidacare. However, it may also cause some reduction in revenue in other product areas. Given the high acceptance rate of the Vidacare products, as well as the high gross margin profile, we believe that this shift in resources is the right strategic move. In addition to investing in more clinical training and cadaver lab workshops, both domestically and abroad, the company also recently received a 510(k) approval for Vidacare product that we believe will also contribute to future revenue growth. In March, the FDA announced the 510(k) clearance for the restated indications for use with the EZ-IO vascular access system. The EZ-IO 25-millimeter needle set is now indicated for patients 3 kilograms or over. This is something that the company did in response to feedback we received from clinicians. And initial feedback is positive, and many clinicians feel that the restated indication will help streamline care and expand EZ-IO usage. Next, I would like to update you on the status of the Mayo distributor acquisition. As a reminder, Teleflex acquired Mayo Healthcare in February this year. Mayo provides high-quality products, education services, technical services and customer support to health care institutions throughout Australia. This is an accretive transaction for Teleflex, funded through the use of foreign cash and it represented the major distributor-to-direct conversion that we referred to in our previously provided 2014 financial guidance. During the first quarter of 2014, Mayo contributed approximately 99 basis points to Teleflex's constant currency revenue growth. This revenue growth came in the form of additional volume and price increases. I'm pleased to say that the integration activities associated with this acquisition remain on track, and I'd like to welcome the Mayo employees to the Teleflex family. And finally, before I turn the call over to Tom, I would like to take a few moments to speak to you about a restructuring plan that we announced this morning. These types of announcements are never easy and every member of the Teleflex senior management team takes these types of decisions very seriously. As we have previously communicated, over the past several months, we have been evaluating opportunities to improve our operating leverage over a multiyear period. The plan we announced today was developed in response to continuing pressures that companies like Teleflex face in the health care industry and is designed to improve our competitive position. The plan is focused on the consolidation of operations and will result in reduction in workforce at certain of the company's facilities. It will include the relocation of manufacturing operations from certain higher-cost locations to existing lower-cost Teleflex locations. We expect actions to commence in the second quarter of this year, and we expect that these actions will be substantially complete by the end of 2017. We currently expect to begin realizing savings under the plan in 2015. As I stated a few moments ago, we tried to be thoughtful when making this decision. And it is our intention to speak with affected employees shortly. I want to point out that we expect the plan, combined with improvements we expect to realize from other initiatives, will enable us to cross over the 55% adjusted gross margin target level by the time we exit 2015. However, it does not represent the total opportunity we have to improve our margins. And we are continuing to evaluate additional future opportunities for margin expansion, and this may result in the company taking additional steps in the future. Having our 55% goal well in sight, we expect to be communicating in the near future about our new long-term margin goals that we believe are achievable by 2018. I realize that this may be an unsettling time for Teleflex employees. I want to thank you for all your hard work and dedication, and you have my commitment that we will treat you in a fair manner as we proceed in the upcoming months and years. Finally, before I turn the call over to Tom, I want to point out that the company recently promoted Liam Kelly to the position of Executive Vice President and President of the Americas. Most recently, Liam had the position of Executive Vice President and President of International. Liam helped generate excellent results while President of International, and I look forward to the improvement he will help bring to the Americas as well. With that, I'd like to now turn the call over to Tom for him to provide you with a more detailed review of our first quarter financial performance, some events that occurred post the completion of the first quarter and our 2014 outlook. Tom?
Thomas E. Powell:
Thanks, Benson, and good morning, everyone. As a headline, Teleflex had a solid first quarter. Revenues slightly exceeded our expectations, adjusted gross margins and adjusted operating margins both showed improvement from year-ago levels and adjusted earnings per share increased over 15% from the prior year first quarter. For the quarter, revenues were $438.5 million which represents an increase of 6% on a constant currency basis. When taking into consideration the impact of foreign exchange, revenues for the first quarter increased 6.5% versus the first quarter of 2013. The growth in constant currency revenue is largely attributable to the acquisitions of Vidacare and Mayo Healthcare, our Australian distributor. In addition, new products added 78 basis points of growth, and core product pricing contributed 56 basis points of growth. Total pricing, including the margin recaptured via the Mayo distributor-to-direct conversion, totaled 108 basis a point -- or 108 points for the quarter. Volume for the quarter decreased 147 basis points and can be attributed to one fewer shipping day in EMEA, a tough Respiratory comparable and a couple of one-off Teleflex Pacific issues that occurred during the quarter. For the quarter, we estimate normalized revenues to be in a range of about 3.5% to 4%, and we arrived at that estimate by excluding the base Vidacare revenue and making adjustments for the shipping day and other one-off items. Turning now to gross profit. For the first quarter, adjusted gross profit was $221.2 million versus $201.1 million in the prior year quarter. Adjusted gross margin increased 161 basis points to 50.4%. The increase in adjusted gross margin was primarily due to the Vidacare acquisition and increased pricing. Further gross margin gains were limited by soft sales of Surgical products and select manufacturing costs, including costs associated with the decision to delay the planned closing of a manufacturing facility. Turning next to adjusted operating margin. For the first quarter, the adjusted operating margin increased 113 basis points to 18.9%. The year-over-year improvement was the outcome of the gross margin gain, coupled with slightly lower R&D spending. Somewhat tempering the gains in operating margin were additional SG&A expenses associated with the Vidacare and Mayo businesses, whose SG&A expense runs considerably higher than that of Teleflex. Moving next to our adjusted tax rate. For the first quarter of 2014, the adjusted tax rate was 24.5% which represents a 340-basis-point improvement when compared to the first quarter of 2013. In past calls, we have discussed several tax planning initiatives that will allow us to reduce our full year 2014 adjusted tax rate to a range of 22.5% to 23.5%. Those planning actions are now largely complete. And as a result, we are well positioned to achieve that full year tax rate target. On the bottom line, first quarter adjusted earnings per share increased 15.1% to $1.22. If you were to exclude the incremental dilution associated with the warrants, first quarter adjusted earnings per share would have increased by 18.9%. And this represents excellent P&L leverage on a reported revenue growth of 6.5%. Before I move on to a discussion of segment revenue results, I'd like to cover the recent changes we have made to our segment reporting. Beginning this quarter, we have increased the level of disclosure on our former Americas segment by expanding that segment into Vascular, Surgical, Anesthesia/Respiratory and Other. Additionally, we made changes to the allocation methodology of R&D costs and certain manufacturing expenses and variances in order to improve the accountability amongst the businesses. This change reflects how we will be managing the business going forward, and all prior periods have been restated for comparability. As an outcome, the company now has 6 reportable segments. Those segments are Vascular North America, Anesthesia/Respiratory North America, Surgical North America, EMEA, Asia and OEM. Certain operating segments have been aggregated and are included in Other. And now, let's turn to a review of the segment revenue results. Vascular North America revenue in the first quarter increased 10.8% to $62.5 million. The increase in Vascular North America revenue was largely due to the addition of Vidacare, new products and price increases. Anesthesia/Respiratory North America revenue decreased 5.6% to $54.7 million. The decline in Anesthesia/Respiratory North America revenue was largely the result of lower procedural trends during the first quarter and unfavorable comps versus the prior year quarter. We expect the negative impact of the unfavorable comps to continue through the second quarter and then improve in the second half of the year. Partially offsetting the decline in Anesthesia/Respiratory North America volume was an increase in the sales of new products and select price increases. Surgical North America revenue in the first quarter decreased 3% to $35.2 million. The decline in Surgical North America revenue was due to lower sales of existing products. Similar to Anesthesia/Respiratory, it is our belief that the reduced volume was primarily the result of lower procedural trends during the first quarter versus the prior year first quarter. Partially offsetting this decline was an increase in the average selling prices of products and new product introductions. Moving to EMEA. Revenue in the first quarter was up 2.5%, totaling $150.2 million. The increase in EMEA revenue was due to Vidacare product sales, price increases and the introduction of new products to the market. Partially offsetting these growth areas was a decline in the existing product volumes due to fewer shipping days. Revenue in Asia increased 20.3% to $49.6 million during the first quarter. The increase in Asia revenue was due to the Vidacare and Mayo Healthcare acquisitions, price increases and higher sales volumes of existing products. During the first quarter, the company experienced particular strength in China, Japan and India. Turning to OEM. Revenue in the first quarter increased 5.3% to $33.2 million. The increase in OEM revenue was due to higher sales volume of existing products, in particular, sutures, and the introduction of new products into the market. As you may recall, OEM was a business that we expected to show a turnaround in 2014, and that's what we're seeing. And lastly, our Other product revenue for the quarter was up 20.9%, totaling $53.1 million. The increase in Other revenue was due to Vidacare sales that fall under our specialty business call point, as well as double-digit sales growth in Latin America. During the quarter, the company experienced particular strength in Argentina, Chile and Mexico. Next, I'd like to provide you with an update on select activity that occurred post the completion of the first quarter. Subsequent to quarter end, Teleflex integrated Vidacare into its legal entity structure. In connection with this integration, we restructured our foreign holdings which enabled us to efficiently repatriate $230 million of cash from our operations outside of the United States. The repatriated cash was then used to fund a $235 million repayment of outstanding principal amount of borrowings under a revolving credit facility. As a result, we now project lower borrowings and lower interest expense than was initially contemplated in our original 2014 financial outlook. And next, I would like to provide you with some additional details surrounding the restructuring plan that we announced this morning. As Benson stated in his prepared remarks, the restructuring plan is designed to reduce costs, improve operating efficiencies and enhance the company's long-term competitive position. We estimate that the company will incur aggregate pretax charges in connection with these activities for approximately $42 million to $53 million, of which approximately $32 million to $40 million will result in future cash outlays. These charges are comprised of a combination of termination benefits, facility closure and exit costs, salary depreciation charges and other cost directly related to the plan, including project management, legal and other regulatory costs. During the course of 2014, the company estimates that it will incur approximately $22 million to $23 million of the aforementioned pretax charges, of which approximately $9 million to $11 million will result in 2014 cash outlays. These charges will be added back when calculating adjusting earnings per share. In addition to these restructuring costs, the company will also to make -- need to make additional capital expenditures. We estimate that the aggregate capital expenditures will be approximately $24 million to $30 million, of which approximately $10 million to $15 million will occur in 2014. And as a result of the actions we've announced this morning, we expect to achieve annualized savings of approximately $28 million to $35 million once the plan is fully implemented, and currently expect realized plan-related savings beginning in 2015. The company will also incur pretax expenses that will not be added back when calculating adjusted earnings per share of approximately $5 million to $6 million in 2014. Next, I would like to provide you with an update regarding our full year 2014 financial outlook. Today, we are reaffirming our previously provided 2014 financial outlook. For 2014, we continue to expect constant currency revenue growth between 7% and 9%. Consistent with our initial expectations, approximately 75% of our projected 2014 constant currency revenue growth will be sourced from a combination of the recently closed Vidacare acquisition and distributor-to-direct conversions. New product introductions are expected to make up the majority of the remaining 25% of the revenue growth with only modest expectations for volume gains and core product price increases. As a reminder, in 2014, we continue to expect approximately 100 basis points of total pricing. However, the majority of that pricing is projected to come from distributor-to-direct conversions. Pure product price increases are expected to be much more selective. And now, turning to adjusted gross margin. As a result of the restructuring plan announced this morning, we'll incur expenses that were not contemplated in our 2014 financial guidance. Approximately $5 million to $6 million of such expenses will be treated as period expense and will be recorded in cost of goods. The balance of the expense will be recorded as restructuring or restructuring-related expense and will be added back for purpose of calculating adjusted earnings. Despite the unplanned cost, we continue to project adjusted gross margin to be in the range between 52% and 52.5% for the year. The projected 2014 gross margin represents an increase of approximately 240 to 290 basis points over 2013 and is largely the result of the addition of Vidacare, distributor-to-direct conversions and manufacturing and operations' efficiency programs. Moving on to adjusted operating margin and earnings per share. For full year 2014, we continue to expect adjusted operating margin, excluding intangible amortization expense, to increase by approximately 100 basis points to a range of 20% to 21%. Further gains in adjusted operating margin are being tempered by investments to support the distributor-to-direct strategy and the addition of Vidacare, which carries a much higher relative level of SG&A. Moving on to taxes. As we discussed earlier, we have now put in place several tax planning initiatives. As a result, we are on track to reduce our full year 2014 adjusted tax rate to a range of 22.5% to 23.5%. Turning next to interest expense and debt. Given the repatriation of funds and the recent $235 million paydown of the revolver, we now expect to realize approximately $0.06 of earnings favorability from reduced interest expense. Additionally, it remains our intention to finance the Vidacare acquisition through the issuance of a longer-term instrument. As a result, it is our current expectation to have approximately $1.1 billion of debt outstanding during the balance of 2014 at an adjusted weighted average interest rate of approximately 5.3%. Turning to shares outstanding. Given the first quarter appreciation in Teleflex's stock price, we are now assuming additional dilution from the warrants. This additional dilution is projected to reduce full year adjusted earnings per share by approximately $0.05 and adjusted weighted average share count is now projected at slightly higher than 44 million shares. And finally, on the bottom line. We are reaffirming our previously provided 2014 adjusted earnings per share range of between $5.35 and $5.55 per share. As can be expected, we have experienced a couple of puts and takes since we first provided 2014 guidance. We now expect to incur both additional period expense from the recently announced restructuring program and additional dilution from the warrants. However, we expect the combination of favorability in first quarter earnings and the projected interest expense favorability to offset these issues 1:1. As a result, our positioning in the guidance range for the adjusted earnings per share remains unchanged from the last time we reaffirmed guidance. In other words, our projections have not moved up or down within the range. And while we do not provide quarterly financial guidance, I will emphasize that we continue to project revenue and adjusted earnings per share to be greater in the second half of 2014 as compared to the first half, with particular strength in the fourth quarter. And there are a couple of reasons that I can point to for the stronger second half. On the revenue front, we expect to complete one additional distributor-to-direct conversion during the fourth quarter. Additionally, Mayo Healthcare was acquired partway through the first quarter, which limited the revenue benefit. During the balance of the year, we expect to see the full impact on revenue growth. Next, in addition to 1 fewer EMEA shipping day in the first quarter, we will have 1 fewer shipping day in the second quarter for both EMEA and North America. We will then pick up these shipping days in the fourth quarter. Further, in the second half, we expect to overcome a tough prior comparable on our Respiratory business. And finally, new product momentum will continue to build as the year progresses. On the earnings front, we project second half earnings to be stronger than the first half for the revenue reasons just mentioned, plus we have a number of manufacturing cost-improvement programs whose benefit will largely be in the second half of the year. Additionally, for the balance of 2014, we expect our adjusted tax rate will be lower than the first quarter. In closing, we have gotten off to a solid start relative to the first quarter financial expectations. We continue to work towards the implementation of financial strategies that will enable Teleflex to deliver earnings momentum regardless of the revenue environment and are excited by the opportunities. That concludes my prepared remarks. And I'll now turn the call back to the operator for questions. Operator?
Operator:
[Operator Instructions] Please stand by from your first question which comes from the line of David Lewis from Morgan Stanley.
David R. Lewis - Morgan Stanley, Research Division:
I just want to start off with the restructuring, guys, whether it's Benson or for Tom. So at first blush, the restructuring announcement is -- represents about 200 basis points of margin expansion, maybe a little lower than we were expecting. So I guess 2-part question. The first thing is, how do we get from your margins today, based on this restructuring, to get to 55% fourth quarter margins? Is that conservatism in this outlook, or is it simply you feel better about the underlying GMs of the core business?
Benson F. Smith:
So we still expect to exit this year at between 52% and 52.5% of gross margin. Some of those things that are contributing to that will spill over into 2015 and provide an additional pump -- an additional bump, excuse me. And then the -- there's a fairly substantial amount of the overall gross margin improvement that will actually hit by the end of 2015. So the combination of those events gets us over that 55% target level. And it was -- first of all, we certainly felt a sense of obligation to do what we could to get above that stated target level. Improvement in other areas in our gross margin has allowed us to take a more conservative cadence to some of the additional manufacturing opportunities in front of us. So it's a combination of some things going better. And I'll cite Vidacare as an example, which contributes significantly to our gross margin improvement that's allowing us to take a little bit more conservative view and -- to the timing of some of these manufacturing moves. But a majority of what we've announced in the restructuring will hit us by the time we exit 2015.
David R. Lewis - Morgan Stanley, Research Division:
Okay. And then the other message that didn't seem to be relatively clear in this call was this notion of perhaps this is a broader restructuring and these numbers could prove conservative. So it sounds like to the extent we're going to see conservatism to the initial restructuring announcement, we're going to see that upside more in 2016 and beyond than 2015?
Benson F. Smith:
So that's exactly the message we're trying to deliver, and that's the point we're trying to make.
Thomas E. Powell:
So just to kind of add on to what Benson said, as we look to move from this year, say we're exiting at the 52.5% rate, what's going to drive us towards that margin by the end of 2015 is some of those footprint savings we'll realize in '15. As Benson mentioned, we also have some pretty strong growth for Vidacare. It's a very high-margin business. That, coupled with international growth, which is growing faster and higher margin, will help drive us as well. We also have another distributor-to-direct conversion scheduled for the fourth quarter of this year. We'll then realize that full year benefit. And we're going to look for more of those opportunities in 2015 as well. We also have quite a few cost-improvement programs scheduled for this year. And as we look to move from where we are in gross margin today to where we're going to exit the year, those cost-improvement programs are going to deliver a lot of movement. And what we're going to see in 2015 is the full year benefit of those programs. And so we'll continue to look for opportunities outside of footprint. We've got opportunities such as material substitution and other projects that we're looking at as well. So we've got a lot of action that's going to help us get there by the end of 2015. That includes part of the footprint. But then the footprint also delivers some pretty significant benefits in '16 and '17 as well.
Operator:
And your next question is from the line of Dave Turkaly from JMP Securities.
David L. Turkaly - JMP Securities LLC, Research Division:
Just to follow up there on the restructuring side. I'm glad to hear that if we're not done in '15, we can continue through '18. But would you be willing to give us today with this plan a reminder of the footprint that you have in terms of facilities? And could you, not specifically name which ones, but at least give us some color as to how many are impacted by what you announced today?
Benson F. Smith:
So that would -- that's, I think, gets us to a position that's beyond what we're able to communicate until we have conversations with our employees about the specific sites.
David L. Turkaly - JMP Securities LLC, Research Division:
Okay, fair enough. And then as a follow-up -- I guess I can't help asking for some detail around this Intuitive Surgical announcement. I take it that'll be a part of your OEM. But I guess if you could give us any color on what you see that -- how you see that contributing. I know it wasn't specifically mentioned as a driver ahead, but any details there would be appreciated.
Benson F. Smith:
So actually, that's a relationship that exists between our Surgical division directly with Intuitive. It's not through our OEM group. They have been working, I think, quite successfully with Intuitive over the past several years. Obviously, the internal projections that we have are based on Intuitive's assumption about what this is -- what their new robot is going to do in the market. And we would feel more comfortable having Intuitive state those numbers publicly than us.
Operator:
And your next question comes from the line of Larry Keusch from Raymond James.
Lawrence S. Keusch - Raymond James & Associates, Inc., Research Division:
I just want to come back on the restructuring and make sure I'm understanding this correctly. So again, on the math, it looks like you're just below 200 basis points of operating margin expansion through the restructuring savings. And I had been under the impression that you guys are articulating restructuring benefits that were at least north of 250 basis points and maybe over 300 basis points. So I'm just trying to reconcile what was said earlier and make sure I understood that versus what we're seeing today.
Benson F. Smith:
So that's a good point. Let me clarify to the extent that I can. We've essentially made considerable progress from a goal to get to 55% to a plan to get there, which has given a lot more clarity to the specific details. If you look solely at the opportunity we believe we have in front of us, in terms of footprint consolidation, it's in the range that we're talking about. But not all of that is included in the current phase that we have. And we are taking this, the whole look at footprint consolidation, relatively cautiously because not only it needs to be done, but it needs to be done right so they don't have supply chain interruptions, et cetera. So we have moderated our initial phase of this to the extent that we think is prudent and what we can get done based on other things happening in our gross margin, which will still get us over that 55% goal. And as I mentioned in my comments, expect to provide more clarity of what the quantification around the overall margin improvement numbers going to look like by the time we get to 2018.
Lawrence S. Keusch - Raymond James & Associates, Inc., Research Division:
Okay. And so just so -- again, so I understand it and then I have just one other question. So the -- what you're essentially saying is there could be other opportunities as we move out in time. And along with that, I would just want to understand the $35 million, this cost savings that you guys are talking about. Does that -- is that contemplated to all drop to the bottom line or does that get reinvested?
Thomas E. Powell:
No, that would be savings that would be dropping to the bottom line.
Lawrence S. Keusch - Raymond James & Associates, Inc., Research Division:
Okay. And just a thought on, again, there's potential other opportunities for restructuring as you move forward.
Benson F. Smith:
Yes.
Operator:
And your next question is from the line of Jason Wittes from Brean Capital.
Jason Wittes - Brean Capital LLC, Research Division:
Just wanted to ask about organic growth this quarter. My math has it slowly flat to negative. I may be off on that. But also, I think if I look at your guidance for the year, it seems like you're backing off a little bit. And I think part of that has to do with your comments about reinvesting or pushing more investment towards Vidacare. Could you just help us out with the numbers and sort of how you're thinking about that?
Benson F. Smith:
So I'm not sure precisely that we're backing off. But we are -- as I mentioned in my comments, we are really pleased with the customer reception that Vidacare is getting. And it is quickly occupying the space of our fastest-growing, highest gross margin product. We want to make sure we capitalize that opportunity fully. This is nested in sales divisions that have other products to sell. But we think it's the right strategic move, certainly short term, to have the focus on that product, which means -- and can result in some lesser selling time on some other products. So I think we're trying to paint the picture that while we expect some overperformance in Vidacare, we might -- this might come at the expense of some of our additional product lines. It's -- I would say it's hard to calibrate exactly what that might look like. We still have some, I think, conservatism built into our numbers based on continuing uncertainty around the Affordable Care Act. All that notwithstanding, there are some unique Teleflex circumstances in a respiratory therapy business, for example, that are going to have much more favorable comparisons in the second half. So all those changes in terms of organic growth rate still lead us to believe that our non-Vidacare growth is going to be in the 3.8% to 4% number by the end of the year.
Jason Wittes - Brean Capital LLC, Research Division:
Okay, that's fair. I don't mean to put words in your mouth there. Also -- go ahead, sir.
Thomas E. Powell:
To put a little more color on it, so if we look at components of growth that we talked about for the year, and we broke it down into 5 different buckets, if you look at kind of what we're getting from pricing, about 110 basis points, that's on the upper end, middle to upper end of the range we talked about for the year. M&A, excluding Vidacare, which would be Mayo, Ultimate and some others, is also trending kind of within the range, around the positive side of the range. Vidacare, as mentioned, is trending favorably. So as you look at those 3, all trending favorably to above where we expected. As we started the year, volume in new products, it was our expectation that it would be on the lower end of the range and that we would see new products building through the year as those new product introductions gained momentum. So while we're a little bit south of our midpoint of our guidance for the year, we expected that. And same thing with volume. As we look at volume, that was below the full year range. But again, we expected that. And the things that will help turn that around is, we mentioned, shipping days. So we've had a -- one fewer shipping day in the first quarter, we expect to pick that up in the back half of the year. Benson mentioned the Respiratory comps, we had a couple of one-off issues that really will correct themselves in the second quarter and otherwise. And in addition, we've got some drivers that will help us in the back half of the year, including getting the full year benefit of the Mayo acquisition, which happened midway through the first quarter and so you didn't get the full benefit of that growth. And then we're looking for one more distributor-to-direct conversion later in the year. So we've got a number of actions that should help that growth as the year progresses. So hopefully, [indiscernible] additional color.
Jason Wittes - Brean Capital LLC, Research Division:
Great. I understand that. And one just quick follow-up. You got a lot of questions about the restructuring plan announced. I think just in terms of thinking about it, you guys have generally said you've had a long-term goal of 55% gross margins by the end of '15. And I assume this is sort of part of that. In addition, you've also said that you expect further leverage beyond that. Those are comments that you've made in the past. If I -- if we were thinking about this restructuring plans, is the right way to think about it, this is really just a more formalization of those goals? And then secondly, as part of that, is most of that improvement going to come from gross margins, or is there also some SG&A in there?
Benson F. Smith:
So the first half of your question, I'll take. And I think that's a pretty good way to phrase it. The only additional comment I would make to that is, and we've said this many times also, that we don't see 55% as the end goal for us. And we see pretty clear opportunities to get beyond that over the next several years beyond then, and we're committed to do that. In terms of some SG&A expenses, depends on where the gross margin improvement is coming from. Vidacare, for example, carries some higher SG&A expenses in order for us to move that product line forward than what it is. Most of the gross margin improvement that comes directly from operations has pretty close to a 1:1 fall-through ratio to our operating margins.
Operator:
And your next question comes from the line of Matt Taylor from Barclays.
Matthew Taylor - Barclays Capital, Research Division:
So I guess I just want to make sure that I'm clear, because there's been a couple of different questions on the restructuring plan. So in terms of your goal, I guess, on the 55% and beyond, you're saying this is more of a formalization versus something that's really truly incremental. So layering on the midpoint $47 million in op margin savings is not necessarily the right way to think about it for the near term. So I guess that's question one. And then question two is just as you rationalize your footprint here, can you give us a sense, and qualitatively, as to where this puts you from a longer-term perspective? Meaning, is this phase one of multiple phases of basically moving to lower-cost jurisdictions? So could we see another plan through 2021 that has the same kind of savings on top of it?
Benson F. Smith:
So we are more likely to try and provide a bit of a shorter-term view in terms of where we expect margins -- what we expect margins to do in '16, '17 and '18. That will encompass, I think, a fairly substantial amount of the margin improvement that comes from operations activities. We might not realize all the savings by the end of '18. Sometimes the actual savings are pushed out somewhat by registration times in foreign governments, et cetera. So we won't realize all those savings by 2018, but I think we can certainly provide some margin guidance in terms of where we expect to be there. It's really not possible, though, for us to talk about the specifics around additional phases. As similar to phase one, until those are approved by the Board of Directors, we're not able to get into much detail about what that looks like. And that's sort of the same boat we've been in for the past couple of years with even discussing phase -- the phase one that's been approved now. We're able to get -- communicate that we think there's good savings potential out there beyond 2015.
Matthew Taylor - Barclays Capital, Research Division:
Understood. And I guess could you just clarify as to what you're really seeing that's new today versus what you've communicated in the past?
Jake Elguicze:
Yes. So, Matt, this is Jake. I would say that, I think, to your point, we had talked about opportunities to expand our gross and our operating margins, and we had talked about how a piece of that is going to come from facility footprint rationalization. And this would be essentially the formalization of a part of that operating margin and gross margin expansion.
Matthew Taylor - Barclays Capital, Research Division:
Okay. And then just a follow-up. I mean, so you're a company that had talked about guidance for this year and been cautious for the first half because of ACA. Can you give us a little more color as to how volumes have been shaping up relative to your expectations and whether you've seen any change from the beginning of the year until now in terms of how that may be impacting your business?
Benson F. Smith:
So our current thinking comes from some recent conversations we've had from some heads of some major health care systems that continue to report slower volume -- slower procedural volume this year than last year. There is, I think, a degree of ambiguity about whether or not those are likely to turn around in the next few months or not. Their physician office visits continue to look negative compared to last year, but they're getting better. They're less negative than they were in the beginning of the year. I would say our own projections for 2014 don't include much in the way of improvement in procedural volumes. Most of our improvement is going to come from other things, comparables, shipping days, et cetera. So we have not counted heavily on this -- on procedural volumes improving in the U.S. as part of our forecast process.
Operator:
And your next question come from the line of Matthew Mishan from KeyBanc.
Matthew Mishan - KeyBanc Capital Markets Inc., Research Division:
Just to follow up on the guidance as well. In my mind -- like interest and shares outstanding seem to be a couple of moving pieces, but they seem to offset each other. But the 3 moving pieces which you can identify as conservative with your guidance, I was hoping you could address it. I guess the developed markets being flat, you talked about the U.S. But what about Europe? Vidacare seems like that's coming in ahead of your expectations now. And also, I think you have, on a currency assumption, a euro of $1.30. That's at $1.39 now. What are the offsets to some of that?
Benson F. Smith:
I'll turn it over to Tom, but you enumerated them pretty well.
Thomas E. Powell:
Yes. So as we look at currency, we are assuming that the euro-U.S. dollar does trend down a little bit. And so we initially put together a plan at $1.30 for the year. We've now got that in at $1.32 balance of the year. So if, in fact, it does stay -- that exchange rate's been bouncing around $1.37 to now $1.39 now over the last couple of months. But if we're to stay at that rate, we would have some upside there. But then you touched on the puts and takes. We've got additional costs hitting our P&L from the restructuring program we just spoke about. That's $5 million to $6 million. We've got additional dilution from the warrants. And again, that's subject to where the stock price goes. But right now, we're assuming, given the move up in the first quarter, that there's going to be additional $0.05 of dilution associated with that. We did have a nice Q1 profit performance that exceeded our internal expectations. And combine that with the interest expense savings, all of those kind of wash out to a breakeven. But then again, depending on where currency plays out, we could see some benefit there. We'll also watch for additional tax planning opportunities, which we're always looking for opportunities to drive that rate lower. So we think we've got a number of actions to continue to drive earnings this year, and we're going to watch real closely on some of the execution items we've got. To deliver the back half of the year, we've got some execution ahead of us. We've got to drive a number of cost-improvement programs in manufacturing, and that will take our gross margins up fairly significantly. And we also have to get the volume growth out of new products that we're counting on. So as we think about those items outside of the 4 I enumerated in my prepared remarks, we got some pluses on currency, maybe some pluses on taxes, maybe some risks elsewhere. And so we think it's a pretty well-balanced financial forecast for the balance of the year.
Jake Elguicze:
And, Matt, you had a question about Europe. Europe actually performed very well this quarter. Their constant currency growth rate was kind of in that 2.5% level, and that's despite really having the -- a negative shipping day for Europe in there. Asia grew well over 20%. And I think we mentioned in our prepared remarks that Latin America grew in the solid double-digit range. So I think all pretty strong performances there.
Matthew Mishan - KeyBanc Capital Markets Inc., Research Division:
And then last question for me. Should we read anything into you moving the cardiac group into Other? And did that group benefit from a new -- the new award with Novation that you talked about towards the end of last year?
Benson F. Smith:
So the group is benefiting from the agreement with Novation, yes. It's just relative to their global size in comparison to our other business segments that led to us combining them together.
Operator:
And your next question is from the line of Matthew O'Brien from William Blair.
Kaila Krum:
It's Kaila in for Matt. Just to piggyback off of the restructuring questions. And I know you don't want to get into too much detail, but we're just trying to get a sense for, if longer term, there's any reason structurally that Teleflex can get closer to that 60% gross margin that some of your peers deliver today.
Benson F. Smith:
So let me rephrase the question to say that there are structural opportunities for us to take advantage of, I believe, that would get us closer to 60%. There are other things, I think, that we also need to do to help in that process. And I think our goal certainly is more in line with -- to look like more like other medical device companies than what Teleflex had looked like historically. I would say -- we're coming from 44%. We've made a lot of progress to date. And I think we have a clearer line of sight of where some of those opportunities now than we had even just a few years ago.
Kaila Krum:
Great. And then one of your competitors recently discussed new product introductions that compete with VasoNova. And we're just curious if you have any commentary there, any changes in that competitive landscape that you're seeing and just your confidence in your market position with that product.
Benson F. Smith:
So it's -- we have not -- we have not had any direct customer feedback about the comparative nature of how that system works. So it's a little too soon to comment. I would say we continue to see strong interest in the VasoNova technology. And it's not simply the system itself. It's the fact that there's an antimicrobial anti-thrombogenic PICC that can be used with it. We're working to make those systems more compatible. And we continue to expect to make additional gains in that market over the next couple of years.
Operator:
And your next question is from the line of Korosh Saba from Stephens Inc.
Korosh Saba - Stephens Inc., Research Division:
Just one more question on the restructuring. Just looking at this year and your ability to, I guess, kind of build a buffer inventory, whether that's going to happen, kind of how you see that impacting margins as we go throughout the year.
Thomas E. Powell:
So in connection with this move, we do anticipate the need to build a little bit of a buffer of inventory. So that's going to happen through the next number of months and quarters. We don't estimate it to be a significant build-up. Part of this strategy involves some redundant manufacturing that reduces the need for all of the inventory carry to be through -- to production. So we don't see that having a major impact on margins for the year. If anything, we'll see some benefit as we more fully utilize our plants. But again, this isn't a significant portion of our total inventory build for the year.
Operator:
And your next question is from the line of Richard Newitter of Leerink Partners.
Richard Newitter - Leerink Swann LLC, Research Division:
Just wanted to ask, you might have said it earlier, did you say anything on pricing and what that was by region on your opening remarks?
Benson F. Smith:
I believe we did. We had essentially favorable pricing in Asia and in Europe. Asia was largely distributor-to-direct pricing improvements. We saw some favorable pricing in Europe. The Australia distributor, obviously, contributed to pricing. But overall, our non-distributor pricing, I think, came in right around 58 basis points. So we're continuing to see a bit better performance in price increases on core products than we had expected a little bit -- than we had expected going into the year.
Thomas E. Powell:
Yes, and that's correct. So the big drivers of that pricing, obviously, are the distributor-to-direct and then the regions Benson mentioned, Asia, EMEA. We had some strength in Latin America. LMA had a little bit of favorable pricing, as did Surgical OEM have a little bit negative pricing due to some competitive reasons. But the big driver again, Asia and EMEA, and that being largely driven by distributor-to-direct.
Richard Newitter - Leerink Swann LLC, Research Division:
Great. And then, Benson, just -- earlier, just on that question about potentially line of sight to -- and more in line with med tech or peer group 60% gross margin. Can you give us a sense -- if you were to take advantage and capitalize on the opportunities that would potentially get you there, what level -- is there a certain level of sales growth or organic sales growth that you would need to achieve there? Or is that still kind of delinked from a dependence on achieving sales growth acceleration?
Benson F. Smith:
So we still believe that the current number that is out there about our likely core volume growth being in the 3% to 5% range is a good number to think about over the next couple of years. For the most part, the gross margin improvement opportunities that we have are not overly dependent on those revenue volumes, but revenue helps. So to the extent that we're able to achieve the higher end of that goal, there's some added benefit that comes from that.
Richard Newitter - Leerink Swann LLC, Research Division:
Okay. So likely, to get beyond the 55% targets that are -- you have officially put out there and formalized today, some level of organic growth acceleration likely would be beyond what you've stated. It would likely be necessary to get you even above that -- the 55% level?
Benson F. Smith:
So no. And what I'm trying to say is we certainly see opportunity to get above 55% that's not particularly revenue-driven. We also think there's an opportunity to get some improvement from revenue. And a lot of it comes actually from the mix. All the new products that we're talking about that we've been introducing to the marketplace have much higher gross margins than our average product portfolio. So the extent that they take a larger portion of our revenue number, they're a big help. So to that extent, there's some revenue contribution that's going to come from the mix of new products entering into the scenario. The number of things that potentially can contribute to gross margin improvement are -- actually, it's a pretty good list. It's mix, it's acquisitions, it's a number of different variables. We've tried to take a conservative view in terms of thinking where we can be at by 2018 and are looking forward to being able to share more details about what that goal looks like and where the elements are. But it's not particularly revenue dependent.
Richard Newitter - Leerink Swann LLC, Research Division:
Got it. And then just lastly on your Intuitive Surgical collaboration that you announced this morning. Is -- are there any particular procedures that the product is specifically used in?
Jake Elguicze:
So I -- it would really be any of the procedures that their new robot would be used in, Rich.
Operator:
Your next question comes from the line of Anthony Petrone from Jefferies Group.
Anthony Petrone - Jefferies LLC, Research Division:
Maybe a follow-up on Intuitive. Can you maybe provide a little bit more detail on that contract from the standpoint of Teleflex? Are you exclusive for troll course [ph] and ports on the Xi [ph]? And maybe what are the economics behind that alliance? Are those products going to be gross margin accretive to Teleflex? And then a few follow-ups.
Jake Elguicze:
So, Anthony, from a Teleflex standpoint, obviously, they're a great partner to be with and someone that we've worked with over the last few years, and they've been a tremendous benefit. I think we -- my understanding is that I believe that it is exclusive. And from a margin standpoint, I mean, our -- I think we've talked in the past, our Surgical business tends to have some of the highest gross margins in all of Teleflex. So continuing to generate opportunities like this with a partner like Intuitive can only help Teleflex.
Anthony Petrone - Jefferies LLC, Research Division:
That's helpful. And then going to -- turning to restructuring. Maybe a different way to ask this is, this quarter, the company put up 18.8% adjusted operating margin. The longer-term goal is 25%. So the restructuring announced today gets you close to 200 basis points of improvement. I'm just wondering, how do you close the gap from an operating standpoint, how much of it is from additional restructuring, how much of it is from mix? And is this target contingent upon doing perhaps other deals? And then one last question after that.
Benson F. Smith:
So our current operating margin goals that we have attached to our gross margin goals, and there's -- we obviously has -- have recently changed the way we're calculating our adjusted operating margins to exclude intangible assets. But -- so I'm going to back, I'm going to predate that. What we suggested was is that a 55% operating -- excuse me, gross margin should generate somewhere between a 21% and 22% adjusted operating margin. That number has moved up as we've -- we calibrated it to include the intangible expense number. But essentially, we're in that same place where we were in terms of what we think the pull-through is going to be. And it -- and those numbers do not include assumptions from future acquisitions, other than some modest improvements in dealer-direct conversions. They don't include another LMA or don't include another Vidacare as part of our calculation to get there.
Thomas E. Powell:
So if you just think about the adjusted gross margin for the quarter coming in at 50.4% and the operating margin at 18.9%, as you start to think about the movement of gross margin, that adds 5 points of margin, which we essentially assume will flow through to operating margin. And so that will take you up to the 24% range. We're also expecting -- as the business grows -- right now, we're making some investments in the SG&A lines to support various growth initiatives, to support our distributor-to-direct, to support investments in China sales force. And we expect those to taper off. And so we're going to expect to see some leverage in our SG&A expenses as the years go on, and that will help us continue to drive that operating margin even higher. So essentially, the big move is the increase in gross profit falling through to the operating line.
Anthony Petrone - Jefferies LLC, Research Division:
That's helpful. And last one for me is you did some repatriation of cash here in the quarter that allowed you to pay down some debt. So maybe just an update on can you repatriate additional funds and where is the company as it stands from a covenant standpoint and be able -- and being able to do deals similar to, say, Vidacare and LMA.
Thomas E. Powell:
Well, certainly, as we looked at the integration of Vidacare, really what we are attempting to do is to integrate Vidacare from both a legal entity and an IT management perspective. And in connection with that, we identified a structure that was efficient in terms of our ability to manage and maximize the value of Vidacare. And some of the unique characteristics of both Vidacare and that integration led to this repatriation. So is the opportunity available in the future? Potentially. But there's some pretty unique circumstances associated with this. So we would not count on that as something definitive, but we'll continue to look for those opportunities as they present themselves. In terms of the -- what the impact on the leverage is, this obviously takes down the amount of debt we've got outstanding. Jake, do you have the latest?
Jake Elguicze:
Yes. So at the end of 2013, our leverage under our revolving credit facility was about 3.6x. At the end of the first quarter, it was closer to 3.5x. If you pro forma the delevering, we're around that 2.8x-type mark. So additional flexibility has been created as a result of the delevering.
Operator:
[Operator Instructions] And we do have a question from the line of Larry Keusch from Raymond James.
Lawrence S. Keusch - Raymond James & Associates, Inc., Research Division:
Yes. Just a quick follow-up. I think, if I have my numbers right, when you initially acquired Vidacare, you were talking about 2014 sales in the $68 million to $72 million range. You did just over $20 million in the first quarter. So how do we think about -- I know you said things are running a bit ahead. But how do we think about that range of $68 million to $72 million now? I mean, should we really be thinking about this annualized closer to $80 million for this year?
Benson F. Smith:
So there were some military orders in the first, which we're excluding from our run rate, and looking at those as a onetime item because they're very hard to predict. So we wouldn't encourage you just to take the first quarter numbers and multiply it by 4. That being said, we're pretty enthusiastic about the reception that this product is getting, and we're going to, I think, as I said in my comments, do more to push it. However, the caution there is that may come at the expense of some other slower growth, lower gross margin products. So we would be careful about adding all that increased potential on top of our -- just on top of our revenue guidance. But I think the way we feel about dollar for dollar, we'd rather sell a Vidacare dollar than we'd rather sell most other things in our product line. So that's -- that is what is encouraging us to make this shift in resource allocations.
Operator:
There are no further questions. And I would now like to turn the call back over to Jake Elguicze for closing remarks.
Jake Elguicze:
Thanks, operator, and thanks, everyone, who joined us for the call today. This concludes the Teleflex Incorporated First Quarter 2014 Earnings Conference Call. Have a good day.