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Zimmer Biomet Holdings, Inc. logo
Zimmer Biomet Holdings, Inc.
ZBH · US · NYSE
108.63
USD
-0.68
(0.63%)
Executives
Name Title Pay
Mr. Sang Yi President of Asia Pacific 1.38M
Mr. Ivan Tornos Chief Operating Officer, President, Chief Executive Officer & Director 2.72M
Mr. Suketu P. Upadhyay Chief Financial Officer and Executive Vice President of Finance, Operations & Supply Chain 2.01M
Mr. Wilfred van Zuilen Group President of Europe, Middle East & Africa 1.47M
Dr. Nitin Goyal M.D. Chief Science, Technology & Innovation Officer --
Mr. Chad F. Phipps Senior Vice President, General Counsel & Secretary 1.32M
Mr. Paul A. Stellato Vice President, Controller & Chief Accounting Officer --
Mr. Shaun Braun Senior Vice President and Chief Information & Digital Officer --
Ms. Rachel H. Ellingson Senior Vice President & Chief Administrative Officer --
Mr. Zachary Ross Weiner CPA Director of Investor Relations --
Insider Transactions
Date Name Title Acquisition Or Disposition Stock / Options # of Shares Price
2024-07-01 VAN ZUILEN WILFRED Group Pres, EMEA A - M-Exempt Common Stock 2633 0
2024-07-01 VAN ZUILEN WILFRED Group Pres, EMEA D - F-InKind Common Stock 557 107.36
2024-07-01 VAN ZUILEN WILFRED Group Pres, EMEA D - M-Exempt Restricted Stock Units 2633 0
2024-06-30 Kurdikar Devdatt director A - A-Award Phantom Stock Units 126.751 108.48
2024-06-30 BEGLEY CHRISTOPHER B director A - A-Award Phantom Stock Units 553.097 108.48
2024-06-30 Farrell Michael J. director A - A-Award Phantom Stock Units 299.594 108.48
2024-06-30 HAGEMANN ROBERT director A - A-Award Phantom Stock Units 311.117 108.48
2024-06-30 Jafry Syed A. director A - A-Award Phantom Stock Units 126.751 108.48
2024-06-30 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 253.503 108.48
2024-06-30 Hilado Maria Teresa director A - A-Award Phantom Stock Units 253.503 108.48
2024-06-30 Shapiro Louis director A - A-Award Phantom Stock Units 126.751 108.48
2024-06-30 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 144.035 108.48
2024-06-20 Kurdikar Devdatt - 0 0
2024-05-31 Yi Sang Group President, Asia Pacific D - S-Sale Common Stock 12857 114.691
2024-06-01 Stellato Paul A VP, Controller & CAO A - M-Exempt Common Stock 627 0
2024-06-01 Stellato Paul A VP, Controller & CAO D - F-InKind Common Stock 197 114.47
2024-06-01 Stellato Paul A VP, Controller & CAO D - M-Exempt Restricted Stock Units 627 0
2024-05-10 Shapiro Louis director A - A-Award Restricted Stock Units 1068.991 0
2024-05-10 Shapiro Louis director A - A-Award Phantom Stock Units 616.726 121.61
2024-05-10 MICHELSON MICHAEL W director A - A-Award Phantom Stock Units 0 121.61
2024-05-10 MICHELSON MICHAEL W director A - A-Award Restricted Stock Units 0 0
2024-05-10 Kolli Sreelakshmi director A - A-Award Restricted Stock Units 1068.991 0
2024-05-10 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 616.726 121.61
2024-05-10 Jafry Syed A. director A - A-Award Restricted Stock Units 1068.991 0
2024-05-10 Jafry Syed A. director A - A-Award Phantom Stock Units 616.726 121.61
2024-05-10 Hilado Maria Teresa director A - A-Award Phantom Stock Units 616.726 121.61
2024-05-10 Hilado Maria Teresa director A - A-Award Restricted Stock Units 1068.991 0
2024-05-10 HAGEMANN ROBERT director A - A-Award Phantom Stock Units 616.726 121.61
2024-05-10 HAGEMANN ROBERT director A - A-Award Restricted Stock Units 1068.991 0
2024-05-10 BERNARD BETSY J director A - A-Award Restricted Stock Units 1068.991 0
2024-05-10 BERNARD BETSY J director A - A-Award Phantom Stock Units 616.726 121.61
2024-05-10 Farrell Michael J. director A - A-Award Phantom Stock Units 616.726 121.61
2024-05-10 Farrell Michael J. director A - A-Award Restricted Stock Units 1068.991 0
2024-05-10 BEGLEY CHRISTOPHER B director A - A-Award Phantom Stock Units 616.726 121.61
2024-05-10 BEGLEY CHRISTOPHER B director A - A-Award Restricted Stock Units 1068.991 0
2024-05-10 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 616.726 121.61
2024-05-10 HIGGINS ARTHUR J director A - A-Award Restricted Stock Units 1068.991 0
2024-04-01 Winkler Lori SVP and CHRO A - M-Exempt Common Stock 772 0
2024-04-01 Winkler Lori SVP and CHRO D - F-InKind Common Stock 215 130.65
2024-04-01 Winkler Lori SVP and CHRO D - M-Exempt Restricted Stock Units 772 0
2024-03-31 MICHELSON MICHAEL W director A - A-Award Phantom Stock Units 207.156 132.75
2024-03-31 Hilado Maria Teresa director A - A-Award Phantom Stock Units 207.156 132.75
2024-03-31 Jafry Syed A. director A - A-Award Phantom Stock Units 103.578 132.75
2024-03-31 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 207.156 132.75
2024-03-31 Farrell Michael J. director A - A-Award Phantom Stock Units 244.821 132.75
2024-03-31 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 117.702 132.75
2024-03-31 BEGLEY CHRISTOPHER B director A - A-Award Phantom Stock Units 451.977 132.75
2024-03-31 HAGEMANN ROBERT director A - A-Award Phantom Stock Units 254.237 132.75
2024-03-31 Shapiro Louis director A - A-Award Phantom Stock Units 103.578 132.75
2024-03-06 Winkler Lori SVP and CHRO D - M-Exempt Restricted Stock Units 1757 0
2024-03-06 Winkler Lori SVP and CHRO A - M-Exempt Common Stock 1757 0
2024-03-06 Winkler Lori SVP and CHRO D - F-InKind Common Stock 428 125.82
2024-03-06 VAN ZUILEN WILFRED Group Pres, EMEA A - M-Exempt Common Stock 2163 0
2024-03-06 VAN ZUILEN WILFRED Group Pres, EMEA D - F-InKind Common Stock 260 125.82
2024-03-06 VAN ZUILEN WILFRED Group Pres, EMEA D - M-Exempt Restricted Stock Units 2163 0
2024-03-06 Upadhyay Suketu Exec. VP, CFO A - M-Exempt Common Stock 4561 0
2024-03-06 Upadhyay Suketu Exec. VP, CFO D - F-InKind Common Stock 1919 125.82
2024-03-06 Upadhyay Suketu Exec. VP, CFO D - M-Exempt Restricted Stock Units 4561 0
2024-03-06 Tornos Ivan President & CEO A - M-Exempt Common Stock 10270 0
2024-03-06 Tornos Ivan President & CEO D - F-InKind Common Stock 5642 125.82
2024-03-06 Tornos Ivan President & CEO D - M-Exempt Restricted Stock Units 10270 0
2024-03-06 Stellato Paul A VP, Controller & CAO D - M-Exempt Restricted Stock Units 609 0
2024-03-06 Stellato Paul A VP, Controller & CAO A - M-Exempt Common Stock 609 0
2024-03-06 Stellato Paul A VP, Controller & CAO D - F-InKind Common Stock 224 125.82
2024-03-06 Phipps Chad F Sr. VP/Gen Counsel/Secretary A - M-Exempt Common Stock 2095 0
2024-03-06 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - F-InKind Common Stock 825 125.82
2024-03-06 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - M-Exempt Restricted Stock Units 2095 0
2024-03-06 Ellingson Rachel SVP & Chief Strategy Officer A - M-Exempt Common Stock 1419 0
2024-03-06 Ellingson Rachel SVP & Chief Strategy Officer D - F-InKind Common Stock 445 125.82
2024-03-06 Ellingson Rachel SVP & Chief Strategy Officer D - M-Exempt Restricted Stock Units 1419 0
2024-03-06 Bezjak Mark President, Americas A - M-Exempt Common Stock 1622 0
2024-03-06 Bezjak Mark President, Americas D - F-InKind Common Stock 395 125.82
2024-03-06 Bezjak Mark President, Americas D - M-Exempt Restricted Stock Units 1622 0
2024-03-07 Yi Sang Group President, Asia Pacific A - M-Exempt Common Stock 1705 91.53
2024-03-07 Yi Sang Group President, Asia Pacific D - S-Sale Common Stock 1705 126.86
2024-03-06 Yi Sang Group President, Asia Pacific A - M-Exempt Common Stock 2365 0
2024-03-06 Yi Sang Group President, Asia Pacific D - M-Exempt Restricted Stock Units 2365 0
2024-03-07 Yi Sang Group President, Asia Pacific D - M-Exempt Employee Stock Option (right to buy) 1705 91.53
2024-03-01 Phipps Chad F Sr. VP/Gen Counsel/Secretary A - M-Exempt Common Stock 1641 0
2024-03-01 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - F-InKind Common Stock 646 124.28
2024-03-01 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - M-Exempt Restricted Stock Units 1641 0
2024-03-01 Yi Sang Group President, Asia Pacific A - M-Exempt Common Stock 2052 0
2024-03-01 Yi Sang Group President, Asia Pacific D - M-Exempt Restricted Stock Units 2052 0
2024-03-02 Winkler Lori SVP and CHRO A - M-Exempt Common Stock 186 0
2024-03-02 Winkler Lori SVP and CHRO D - F-InKind Common Stock 46 124.28
2024-03-02 Winkler Lori SVP and CHRO D - M-Exempt Restricted Stock Units 186 0
2024-02-25 Upadhyay Suketu Exec. VP, CFO A - M-Exempt Common Stock 7043 0
2024-02-25 Upadhyay Suketu Exec. VP, CFO D - F-InKind Common Stock 2091 128.8
2024-02-25 Upadhyay Suketu Exec. VP, CFO D - M-Exempt Restricted Stock Units 7043 0
2024-02-25 Tornos Ivan President & CEO A - M-Exempt Common Stock 7513 0
2024-02-25 Tornos Ivan President & CEO D - F-InKind Common Stock 3028 128.8
2024-02-25 Tornos Ivan President & CEO D - M-Exempt Restricted Stock Units 7513 0
2024-02-25 Phipps Chad F Sr. VP/Gen Counsel/Secretary A - M-Exempt Common Stock 4580 0
2024-02-25 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - F-InKind Common Stock 1769 128.8
2024-02-25 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - M-Exempt Restricted Stock Units 4580 0
2024-02-25 Ellingson Rachel SVP & Chief Strategy Officer A - M-Exempt Common Stock 1762 0
2024-02-25 Ellingson Rachel SVP & Chief Strategy Officer D - F-InKind Common Stock 588 128.8
2024-02-25 Ellingson Rachel SVP & Chief Strategy Officer D - M-Exempt Restricted Stock Units 1762 0
2024-02-25 Winkler Lori SVP and CHRO A - M-Exempt Common Stock 1294 0
2024-02-25 Winkler Lori SVP and CHRO D - F-InKind Common Stock 351 128.8
2024-02-25 Winkler Lori SVP and CHRO D - M-Exempt Restricted Stock Units 1294 0
2024-02-25 Bezjak Mark President, Americas A - M-Exempt Common Stock 1528 0
2024-02-25 Bezjak Mark President, Americas D - F-InKind Common Stock 404 128.8
2024-02-25 Bezjak Mark President, Americas D - M-Exempt Restricted Stock Units 1528 0
2024-02-25 Yi Sang Group President, Asia Pacific A - M-Exempt Common Stock 5047 0
2024-02-25 Yi Sang Group President, Asia Pacific D - M-Exempt Restricted Stock Units 5047 0
2024-02-22 Phipps Chad F Sr. VP/Gen Counsel/Secretary A - M-Exempt Common Stock 26156 91.53
2024-02-22 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - S-Sale Common Stock 25546 128.6067
2024-02-22 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - S-Sale Common Stock 610 129.0807
2024-02-22 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - M-Exempt Employee Stock Option (right to buy) 26156 91.53
2024-02-20 Stellato Paul A VP, Controller & CAO A - A-Award Restricted Stock Units 2104 0
2024-02-20 Bezjak Mark President, Americas A - A-Award Restricted Stock Units 7556 0
2024-02-20 VAN ZUILEN WILFRED Group Pres, EMEA A - A-Award Restricted Stock Units 7352 0
2024-02-20 Winkler Lori SVP and CHRO A - A-Award Restricted Stock Units 5718 0
2024-02-20 Phipps Chad F Sr. VP/Gen Counsel/Secretary A - A-Award Restricted Stock Units 6739 0
2024-02-20 Yi Sang Group President, Asia Pacific A - A-Award Restricted Stock Units 7147 0
2024-02-20 Tornos Ivan President and CEO A - A-Award Restricted Stock Units 47987 0
2024-02-20 Upadhyay Suketu Exec. VP, CFO A - A-Award Restricted Stock Units 16336 0
2024-02-20 Ellingson Rachel SVP & Chief Strategy Officer A - A-Award Restricted Stock Units 4697 0
2024-01-05 Shapiro Louis - 0 0
2023-12-31 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 128.263 121.82
2023-12-31 BEGLEY CHRISTOPHER B director A - A-Award Phantom Stock Units 492.53 121.82
2023-12-31 BERNARD BETSY J director A - A-Award Phantom Stock Units 256.526 121.82
2023-12-31 Farrell Michael J. director A - A-Award Phantom Stock Units 266.787 121.82
2023-12-31 MICHELSON MICHAEL W director A - A-Award Phantom Stock Units 225.743 121.82
2023-12-31 Jafry Syed A. director A - A-Award Phantom Stock Units 112.871 121.82
2023-12-31 Hilado Maria Teresa director A - A-Award Phantom Stock Units 225.743 121.82
2023-12-31 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 225.743 121.82
2023-12-31 HAGEMANN ROBERT director A - A-Award Phantom Stock Units 277.048 121.82
2023-12-13 Bezjak Mark President, Americas D - Common Stock 0 0
2023-12-13 Bezjak Mark President, Americas D - Employee Stock Option (right to buy) 1999 118.25
2023-12-13 Bezjak Mark President, Americas D - Employee Stock Option (right to buy) 4123 116.89
2023-12-13 Bezjak Mark President, Americas D - Employee Stock Option (right to buy) 2862 111.03
2023-12-13 Bezjak Mark President, Americas D - Employee Stock Option (right to buy) 1345 120.04
2023-12-13 Bezjak Mark President, Americas D - Employee Stock Option (right to buy) 4035 124.07
2023-12-13 Bezjak Mark President, Americas D - Employee Stock Option (right to buy) 9395 152.84
2023-12-13 Bezjak Mark President, Americas D - Restricted Stock Units 4864 0
2023-12-13 Bezjak Mark President, Americas D - Employee Stock Option (right to buy) 7574 158.9
2023-12-13 Bezjak Mark President, Americas D - Employee Stock Option (right to buy) 18759 117.22
2023-11-09 Jafry Syed A. director A - P-Purchase Common Stock 2135 104.75
2023-09-30 BEGLEY CHRISTOPHER B director A - A-Award Phantom Stock Units 531.161 112.96
2023-09-30 BERNARD BETSY J director A - A-Award Phantom Stock Units 276.647 112.96
2023-09-30 Farrell Michael J. director A - A-Award Phantom Stock Units 320.91 112.96
2023-09-30 HAGEMANN ROBERT director A - A-Award Phantom Stock Units 298.778 112.96
2023-09-30 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 287.712 112.96
2023-09-30 Hilado Maria Teresa director A - A-Award Phantom Stock Units 243.449 112.96
2023-09-30 Jafry Syed A. director A - A-Award Phantom Stock Units 121.725 112.96
2023-09-30 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 138.324 112.96
2023-09-30 MICHELSON MICHAEL W director A - A-Award Phantom Stock Units 243.449 112.96
2023-08-28 BEGLEY CHRISTOPHER B director A - P-Purchase Common Stock 1000 117.114
2023-09-01 Stellato Paul A VP, Controller & CAO A - A-Award Restricted Stock Units 1281 0
2023-09-01 Tornos Ivan President and CEO A - A-Award Restricted Stock Units 14491 0
2023-08-30 Kolli Sreelakshmi director A - P-Purchase Common Stock 1000 120.37
2023-08-28 HAGEMANN ROBERT director A - P-Purchase Common Stock 2000 116.48
2023-08-25 MICHELSON MICHAEL W director A - P-Purchase Common Stock 1300 115.5
2023-08-25 BERNARD BETSY J director A - P-Purchase Common Stock 871 114.8364
2018-03-20 BERNARD BETSY J director A - P-Purchase Common Stock 150 111.8867
2023-08-23 HIGGINS ARTHUR J director A - P-Purchase Common Stock 500 114.6751
2023-08-23 HIGGINS ARTHUR J director A - P-Purchase Common Stock 500 116.55
2023-06-30 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 106.648 146.51
2023-06-30 Farrell Michael J. director A - A-Award Phantom Stock Units 247.423 146.51
2023-06-30 BEGLEY CHRISTOPHER B director A - A-Award Phantom Stock Units 255.955 146.51
2023-06-30 BERNARD BETSY J director A - A-Award Phantom Stock Units 213.296 146.51
2023-06-30 Farrell Michael J. director A - A-Award Phantom Stock Units 213.296 146.51
2023-06-30 HAGEMANN ROBERT director A - A-Award Phantom Stock Units 230.359 146.51
2023-06-30 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 221.827 146.51
2023-06-30 Hilado Maria Teresa director A - A-Award Phantom Stock Units 187.7 146.51
2023-06-30 Jafry Syed A. director A - A-Award Phantom Stock Units 93.85 146.51
2023-06-30 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 93.85 146.51
2023-06-30 MICHELSON MICHAEL W director A - A-Award Phantom Stock Units 187.7 146.51
2023-07-01 Upadhyay Suketu Exec. VP, CFO A - M-Exempt Common Stock 3768 0
2023-07-01 Upadhyay Suketu Exec. VP, CFO D - F-InKind Common Stock 1677 146.51
2023-07-01 Upadhyay Suketu Exec. VP, CFO D - M-Exempt Restricted Stock Units 3768 0
2023-07-01 VAN ZUILEN WILFRED Pres, Europe, M. East & Africa D - M-Exempt Restricted Stock Units 2633 0
2023-07-01 VAN ZUILEN WILFRED Pres, Europe, M. East & Africa A - M-Exempt Common Stock 2633 0
2023-06-01 Stellato Paul A VP, Controller & CAO D - M-Exempt Restricted Stock Units 628 0
2023-06-01 Stellato Paul A VP, Controller & CAO A - M-Exempt Common Stock 628 0
2023-06-01 Stellato Paul A VP, Controller & CAO D - F-InKind Common Stock 197 127.19
2023-05-12 MICHELSON MICHAEL W director A - A-Award Phantom Stock Units 500 136.73
2023-05-12 MICHELSON MICHAEL W director A - A-Award Restricted Stock Units 950.779 0
2023-05-12 Kolli Sreelakshmi director A - A-Award Restricted Stock Units 950.779 0
2023-05-12 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 500 136.73
2023-05-12 Jafry Syed A. director A - A-Award Restricted Stock Units 950.779 0
2023-05-12 Jafry Syed A. director A - A-Award Phantom Stock Units 500 136.73
2023-05-12 HAGEMANN ROBERT director A - A-Award Phantom Stock Units 500 136.73
2023-05-12 HAGEMANN ROBERT director A - A-Award Restricted Stock Units 950.779 0
2023-05-12 Farrell Michael J. director A - A-Award Phantom Stock Units 500 136.73
2023-05-12 Farrell Michael J. director A - A-Award Restricted Stock Units 950.779 0
2023-05-12 BEGLEY CHRISTOPHER B director A - A-Award Phantom Stock Units 500 136.73
2023-05-12 BEGLEY CHRISTOPHER B director A - A-Award Restricted Stock Units 950.779 0
2023-05-12 BERNARD BETSY J director A - A-Award Restricted Stock Units 950.779 0
2023-05-12 BERNARD BETSY J director A - A-Award Phantom Stock Units 500 136.73
2023-05-12 Hilado Maria Teresa director A - A-Award Phantom Stock Units 500 136.73
2023-05-12 Hilado Maria Teresa director A - A-Award Restricted Stock Units 950.779 0
2023-05-12 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 500 136.73
2023-05-12 HIGGINS ARTHUR J director A - A-Award Restricted Stock Units 950.779 0
2023-03-31 MICHELSON MICHAEL W director A - A-Award Phantom Stock Units 213.991 128.51
2023-03-31 Jafry Syed A. director A - A-Award Phantom Stock Units 106.996 128.51
2023-03-31 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 106.996 128.51
2023-03-31 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 252.898 128.51
2023-03-31 Hilado Maria Teresa director A - A-Award Phantom Stock Units 213.991 128.51
2023-03-31 HAGEMANN ROBERT director A - A-Award Phantom Stock Units 262.625 128.51
2023-03-31 Farrell Michael J. director A - A-Award Phantom Stock Units 243.172 128.51
2023-03-31 BERNARD BETSY J director A - A-Award Phantom Stock Units 243.172 128.51
2023-03-31 BEGLEY CHRISTOPHER B director A - A-Award Phantom Stock Units 291.806 128.51
2023-03-17 Phipps Chad F Sr. VP/Gen Counsel/Secretary A - M-Exempt Common Stock 23045 70.97
2023-03-17 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - S-Sale Common Stock 19743 124.402
2023-03-17 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - S-Sale Common Stock 3302 125.089
2023-03-17 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - M-Exempt Employee Stock Option (right to buy) 23045 70.97
2023-03-06 Hanson Bryan C President and CEO A - A-Award Restricted Stock Units 47625 0
2023-03-06 Upadhyay Suketu Exec. VP, CFO A - A-Award Restricted Stock Units 13680 0
2023-03-06 Tornos Ivan Chief Operating Officer A - A-Award Restricted Stock Units 16315 0
2023-03-06 Yi Sang President, Asia Pacific A - A-Award Restricted Stock Units 7094 0
2023-03-06 VAN ZUILEN WILFRED Pres, Europe, M. East & Africa A - A-Award Restricted Stock Units 6486 0
2023-03-06 Phipps Chad F Sr. VP/Gen Counsel/Secretary A - A-Award Restricted Stock Units 6283 0
2023-03-06 Winkler Lori SVP and CHRO A - A-Award Restricted Stock Units 5270 0
2023-03-06 Ellingson Rachel SVP & Chief Strategy Officer A - A-Award Restricted Stock Units 4256 0
2023-03-06 Stellato Paul A VP, Controller & CAO A - A-Award Restricted Stock Units 1824 0
2023-03-02 Winkler Lori SVP and CHRO A - M-Exempt Common Stock 187 0
2023-03-02 Winkler Lori SVP and CHRO D - F-InKind Common Stock 56 122.14
2023-03-02 Winkler Lori SVP and CHRO D - M-Exempt Restricted Stock Units 187 0
2023-02-21 Yi Sang President, Asia Pacific A - M-Exempt Common Stock 2423 0
2023-02-21 Yi Sang President, Asia Pacific D - A-Award Restricted Stock Units 2423 0
2023-02-21 Tornos Ivan Chief Operating Officer A - M-Exempt Common Stock 4011 0
2023-02-21 Tornos Ivan Chief Operating Officer D - F-InKind Common Stock 1628 124.73
2023-02-21 Tornos Ivan Chief Operating Officer D - M-Exempt Restricted Stock Units 4011 0
2023-02-21 Hanson Bryan C President and CEO A - M-Exempt Common Stock 15132 0
2023-02-21 Hanson Bryan C President and CEO D - F-InKind Common Stock 4752 124.73
2023-02-21 Hanson Bryan C President and CEO D - M-Exempt Restricted Stock Units 15132 0
2023-02-21 Phipps Chad F Sr. VP/Gen Counsel/Secretary A - M-Exempt Common Stock 2195 0
2023-02-21 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - F-InKind Common Stock 562 124.73
2023-02-21 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - M-Exempt Restricted Stock Units 2195 0
2023-02-21 Ellingson Rachel SVP & Chief Strategy Officer A - M-Exempt Common Stock 1046 0
2023-02-21 Ellingson Rachel SVP & Chief Strategy Officer D - F-InKind Common Stock 361 124.73
2023-02-21 Ellingson Rachel SVP & Chief Strategy Officer D - M-Exempt Restricted Stock Units 1046 0
2023-02-21 Upadhyay Suketu Exec. VP, CFO A - M-Exempt Common Stock 3860 0
2023-02-21 Upadhyay Suketu Exec. VP, CFO D - F-InKind Common Stock 1155 124.73
2023-02-21 Upadhyay Suketu Exec. VP, CFO D - M-Exempt Restricted Stock Units 3860 0
2022-12-31 MICHELSON MICHAEL W director A - A-Award Phantom Stock Units 216.587 0
2022-12-31 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 108.293 0
2022-12-31 Jafry Syed A. director A - A-Award Phantom Stock Units 108.293 0
2022-12-31 Hilado Maria Teresa director A - A-Award Phantom Stock Units 216.587 0
2022-12-31 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 255.966 0
2022-12-31 HAGEMANN ROBERT director A - A-Award Phantom Stock Units 265.811 0
2022-12-31 Farrell Michael J. director A - A-Award Phantom Stock Units 246.122 0
2022-12-31 BERNARD BETSY J director A - A-Award Phantom Stock Units 246.122 0
2022-12-31 BEGLEY CHRISTOPHER B director A - A-Award Phantom Stock Units 295.346 0
2022-12-13 Phipps Chad F Sr. VP/Gen Counsel/Secretary A - M-Exempt Common Stock 11522 70.97
2022-12-13 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - S-Sale Common Stock 10459 128.5578
2022-12-13 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - S-Sale Common Stock 1063 129.344
2022-12-13 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - M-Exempt Employee Stock Option (right to buy) 11522 0
2022-12-03 Tornos Ivan Chief Operating Officer A - M-Exempt Common Stock 1571 0
2022-12-03 Tornos Ivan Chief Operating Officer D - F-InKind Common Stock 869 122.76
2022-12-03 Tornos Ivan Chief Operating Officer A - M-Exempt Common Stock 954 0
2022-12-03 Tornos Ivan Chief Operating Officer D - F-InKind Common Stock 462 122.76
2022-12-03 Tornos Ivan Chief Operating Officer A - M-Exempt Common Stock 1123 0
2022-12-03 Tornos Ivan Chief Operating Officer D - F-InKind Common Stock 453 122.76
2022-12-03 Tornos Ivan Chief Operating Officer D - M-Exempt Restricted Stock Units 1571 0
2022-09-30 BEGLEY CHRISTOPHER B director A - A-Award Phantom Stock Units 352.344 0
2022-09-30 MICHELSON MICHAEL W director A - A-Award Phantom Stock Units 258.386 0
2022-09-30 Hilado Maria Teresa director A - A-Award Phantom Stock Units 258.386 0
2022-09-30 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 305.365 0
2022-09-30 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 129.193 0
2022-09-30 Jafry Syed A. director A - A-Award Phantom Stock Units 129.193 0
2022-09-30 HAGEMANN ROBERT director A - A-Award Phantom Stock Units 317.11 0
2022-09-30 Farrell Michael J. director A - A-Award Phantom Stock Units 293.62 0
2022-09-30 BERNARD BETSY J director A - A-Award Phantom Stock Units 293.62 0
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2022-07-01 VAN ZUILEN WILFRED Pres, Europe, M. East & Africa D - S-Sale Common Stock 531 105.217
2022-07-01 Upadhyay Suketu Exec. VP, CFO A - M-Exempt Common Stock 3768 0
2022-07-01 Upadhyay Suketu Exec. VP, CFO D - F-InKind Common Stock 1249 105.85
2022-07-01 Upadhyay Suketu Exec. VP, CFO D - M-Exempt Restricted Stock Units 3768 0
2022-06-30 BEGLEY CHRISTOPHER B A - A-Award Phantom Stock Units 356.973 0
2022-06-30 BERNARD BETSY J A - A-Award Phantom Stock Units 297.477 0
2022-06-30 BERNARD BETSY J director A - A-Award Phantom Stock Units 297.477 105.05
2022-06-30 Farrell Michael J. A - A-Award Phantom Stock Units 297.477 0
2022-06-30 Farrell Michael J. director A - A-Award Phantom Stock Units 297.477 105.05
2022-06-30 HAGEMANN ROBERT A - A-Award Phantom Stock Units 321.275 0
2022-06-30 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 309.376 105.05
2022-06-30 HIGGINS ARTHUR J A - A-Award Phantom Stock Units 309.376 0
2022-06-30 Hilado Maria Teresa A - A-Award Phantom Stock Units 261.78 0
2022-06-30 Jafry Syed A. A - A-Award Phantom Stock Units 130.89 0
2022-06-30 Kolli Sreelakshmi A - A-Award Phantom Stock Units 130.89 0
2022-06-30 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 130.89 105.05
2022-06-30 MICHELSON MICHAEL W A - A-Award Phantom Stock Units 261.78 0
2022-06-30 MICHELSON MICHAEL W director A - A-Award Phantom Stock Units 261.78 105.05
2022-06-01 Stellato Paul A VP, Controller & CAO A - A-Award Employee Stock Option (right to buy) 6048 118.87
2022-06-01 Stellato Paul A VP, Controller & CAO A - A-Award Restricted Stock Units 1881 0
2022-05-16 Stellato Paul A officer - 0 0
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2022-05-13 Farrell Michael J. director A - A-Award Phantom Stock Units 500 115.13
2022-05-13 Farrell Michael J. director A - A-Award Restricted Stock Units 1129.158 0
2022-05-13 HAGEMANN ROBERT A - A-Award Phantom Stock Units 500 0
2022-05-13 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 500 115.13
2022-05-13 HIGGINS ARTHUR J A - A-Award Restricted Stock Units 1129.158 0
2022-05-13 Jafry Syed A. A - A-Award Phantom Stock Units 500 0
2022-05-13 Kolli Sreelakshmi A - A-Award Restricted Stock Units 1129.158 0
2022-05-13 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 500 115.13
2022-05-13 MICHELSON MICHAEL W director A - A-Award Phantom Stock Units 500 115.13
2022-05-13 MICHELSON MICHAEL W A - A-Award Restricted Stock Units 1129.158 0
2022-05-13 Hilado Maria Teresa A - A-Award Restricted Stock Units 1129.158 0
2022-05-13 BEGLEY CHRISTOPHER B A - A-Award Phantom Stock Units 500 0
2022-05-13 BERNARD BETSY J A - A-Award Restricted Stock Units 1129.158 0
2022-05-13 BERNARD BETSY J director A - A-Award Phantom Stock Units 500 115.13
2022-05-01 Ellingson Rachel SVP & Chief Strategy Officer D - F-InKind Common Stock 167 122.43
2022-05-01 Ellingson Rachel SVP & Chief Strategy Officer D - M-Exempt Restricted Stock Units 531 0
2022-03-31 MICHELSON MICHAEL W A - A-Award Phantom Stock Units 213.46 0
2022-03-31 MICHELSON MICHAEL W director A - A-Award Phantom Stock Units 213.46 128.83
2022-03-31 Kolli Sreelakshmi A - A-Award Phantom Stock Units 106.73 0
2022-03-31 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 106.73 128.83
2022-03-31 Jafry Syed A. A - A-Award Phantom Stock Units 106.73 0
2022-03-31 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 252.271 128.83
2022-03-31 HIGGINS ARTHUR J A - A-Award Phantom Stock Units 252.271 0
2022-03-31 HAGEMANN ROBERT A - A-Award Phantom Stock Units 261.974 0
2022-03-31 BERNARD BETSY J A - A-Award Phantom Stock Units 242.568 0
2022-03-31 BERNARD BETSY J director A - A-Award Phantom Stock Units 242.568 128.83
2022-03-31 Farrell Michael J. A - A-Award Phantom Stock Units 242.568 0
2022-03-31 Farrell Michael J. director A - A-Award Phantom Stock Units 242.568 128.83
2022-03-31 BEGLEY CHRISTOPHER B A - A-Award Phantom Stock Units 291.082 0
2022-03-31 Hilado Maria Teresa A - A-Award Phantom Stock Units 213.46 0
2022-03-17 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - S-Sale Common Stock 29518 121.8996
2022-03-17 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - M-Exempt Employee Stock Option (right to buy) 35149 0
2022-03-10 Winkler Lori SVP and CHRO D - F-InKind Common Stock 65 123.08
2022-03-02 Winkler Lori SVP and CHRO D - M-Exempt Restricted Stock Units 181 0
2022-03-01 Yi Sang President, Asia Pacific A - A-Award Restricted Stock Units 2052 0
2022-03-01 Winkler Lori SVP and CHRO A - A-Award Restricted Stock Units 1254 0
2022-03-01 Upadhyay Suketu Exec. VP, CFO A - A-Award Restricted Stock Units 6831 0
2022-03-01 Upadhyay Suketu Exec. VP, CFO A - A-Award Restricted Stock Units 3744 0
2022-03-01 Tornos Ivan Chief Operating Officer A - A-Award Restricted Stock Units 7287 0
2022-03-01 Tornos Ivan Chief Operating Officer A - A-Award Restricted Stock Units 3891 0
2022-03-01 Phipps Chad F Sr. VP/Gen Counsel/Secretary A - A-Award Restricted Stock Units 4442 0
2022-03-01 Phipps Chad F Sr. VP/Gen Counsel/Secretary A - A-Award Restricted Stock Units 2129 0
2022-03-01 Phipps Chad F Sr. VP/Gen Counsel/Secretary A - A-Award Restricted Stock Units 1641 0
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2022-03-01 Ellingson Rachel SVP & Chief Strategy Officer A - A-Award Restricted Stock Units 1014 0
2022-03-01 Davis Derek M Interim Controller & CAO A - A-Award Restricted Stock Units 1026 0
2022-03-01 Davis Derek M Interim Controller & CAO A - A-Award Restricted Stock Units 661 0
2022-03-01 Hanson Bryan C President and CEO A - A-Award Restricted Stock Units 26524 0
2022-03-01 Hanson Bryan C President and CEO A - A-Award Restricted Stock Units 14680 0
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2022-02-18 Phipps Chad F Sr. VP/Gen Counsel/Secretary A - A-Award Employee Stock Option (right to buy) 23507 120.82
2022-02-18 Ellingson Rachel SVP & Chief Strategy Officer A - A-Award Employee Stock Option (right to buy) 12891 120.82
2022-02-18 Davis Derek M Interim Controller & CAO A - A-Award Employee Stock Option (right to buy) 7583 120.82
2022-02-18 Yi Sang President, Asia Pacific A - A-Award Employee Stock Option (right to buy) 25782 120.82
2022-02-18 Hanson Bryan C President and CEO A - A-Award Employee Stock Option (right to buy) 166819 120.82
2022-02-18 Upadhyay Suketu Exec. VP, CFO A - A-Award Employee Stock Option (right to buy) 50046 120.82
2022-02-18 VAN ZUILEN WILFRED Pres, Europe, M. East & Africa A - A-Award Employee Stock Option (right to buy) 21232 120.82
2022-02-18 Tornos Ivan Chief Operating Officer A - A-Award Employee Stock Option (right to buy) 59903 120.82
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2021-12-31 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 107.397 128.03
2021-12-31 HAGEMANN ROBERT director A - A-Award Phantom Stock Units 263.61 128.03
2021-12-31 Hilado Maria Teresa director A - A-Award Phantom Stock Units 214.794 128.03
2021-12-31 Farrell Michael J. director A - A-Award Phantom Stock Units 244.083 128.03
2021-12-31 Jafry Syed A. director A - A-Award Phantom Stock Units 107.397 128.03
2021-12-31 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 253.846 128.03
2021-12-31 BEGLEY CHRISTOPHER B director A - A-Award Phantom Stock Units 292.9 128.03
2021-12-31 MICHELSON MICHAEL W director A - A-Award Phantom Stock Units 214.793 128.03
2021-12-31 BERNARD BETSY J director A - A-Award Phantom Stock Units 244.083 128.03
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2021-12-19 Hanson Bryan C President and CEO D - F-InKind Common Stock 15270 120.94
2021-12-19 Hanson Bryan C President and CEO A - M-Exempt Common Stock 25520 0
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2021-12-19 Hanson Bryan C President and CEO D - M-Exempt Performance Restricted Stock Units 32950 0
2021-12-14 Yi Sang President, Asia Pacific D - S-Sale Common Stock 2600 124.14
2021-12-14 Yi Sang President, Asia Pacific D - S-Sale Common Stock 200 124.175
2021-12-03 Tornos Ivan Chief Operating Officer A - M-Exempt Common Stock 1524 0
2021-12-03 Tornos Ivan Chief Operating Officer D - F-InKind Common Stock 875 121.98
2021-12-03 Tornos Ivan Chief Operating Officer A - M-Exempt Common Stock 925 0
2021-12-03 Tornos Ivan Chief Operating Officer A - M-Exempt Common Stock 1089 0
2021-12-03 Tornos Ivan Chief Operating Officer D - F-InKind Common Stock 531 121.98
2021-12-03 Tornos Ivan Chief Operating Officer D - F-InKind Common Stock 625 121.98
2021-12-03 Tornos Ivan Chief Operating Officer D - M-Exempt Restricted Stock Units 1524 0
2021-12-03 Tornos Ivan Chief Operating Officer D - M-Exempt Restricted Stock Units 1089 0
2021-12-03 Tornos Ivan Chief Operating Officer D - M-Exempt Restricted Stock Units 925 0
2021-11-26 Davis Derek M Interim Controller & CAO D - Common Stock 0 0
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2021-11-26 Davis Derek M Interim Controller & CAO D - Employee Stock Option (right to buy) 10680 104.01
2021-11-26 Davis Derek M Interim Controller & CAO D - Employee Stock Option (right to buy) 8725 121.88
2021-11-26 Davis Derek M Interim Controller & CAO D - Employee Stock Option (right to buy) 9805 119.61
2021-11-26 Davis Derek M Interim Controller & CAO D - Employee Stock Option (right to buy) 8335 114.44
2021-11-26 Davis Derek M Interim Controller & CAO D - Employee Stock Option (right to buy) 6533 123.73
2021-11-26 Davis Derek M Interim Controller & CAO D - Employee Stock Option (right to buy) 7133 157.54
2021-11-26 Davis Derek M Interim Controller & CAO D - Employee Stock Option (right to buy) 5088 163.79
2021-11-26 Davis Derek M Interim Controller & CAO D - Common Stock 0 0
2021-11-26 Davis Derek M Interim Controller & CAO D - Employee Stock Option (right to buy) 9445 113.83
2021-11-26 Davis Derek M Interim Controller & CAO D - Employee Stock Option (right to buy) 10680 104.01
2021-11-26 Davis Derek M Interim Controller & CAO D - Employee Stock Option (right to buy) 8725 121.88
2021-11-26 Davis Derek M Interim Controller & CAO D - Employee Stock Option (right to buy) 9805 119.61
2021-11-26 Davis Derek M Interim Controller & CAO D - Employee Stock Option (right to buy) 8335 114.44
2021-11-26 Davis Derek M Interim Controller & CAO D - Employee Stock Option (right to buy) 6533 123.73
2021-11-26 Davis Derek M Interim Controller & CAO D - Employee Stock Option (right to buy) 7133 157.54
2021-11-26 Davis Derek M Interim Controller & CAO D - Employee Stock Option (right to buy) 5088 163.79
2021-10-01 Nichol Carrie Ann VP, Controller & CAO A - M-Exempt Common Stock 164 0
2021-10-01 Nichol Carrie Ann VP, Controller & CAO D - F-InKind Common Stock 52 148.57
2021-10-01 Nichol Carrie Ann VP, Controller & CAO D - M-Exempt Restricted Stock Units 164 0
2021-09-30 MICHELSON MICHAEL W director A - A-Award Phantom Stock Units 185.347 148.37
2021-09-30 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 92.674 148.37
2021-09-30 Jafry Syed A. director A - A-Award Phantom Stock Units 92.674 148.37
2021-09-30 Hilado Maria Teresa director A - A-Award Phantom Stock Units 185.347 148.37
2021-09-30 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 219.047 148.37
2021-09-30 HAGEMANN ROBERT director A - A-Award Phantom Stock Units 227.471 148.37
2021-09-30 Farrell Michael J. director A - A-Award Phantom Stock Units 210.622 148.37
2021-09-30 BEGLEY CHRISTOPHER B director A - A-Award Phantom Stock Units 252.746 148.37
2021-09-30 BERNARD BETSY J director A - A-Award Phantom Stock Units 210.622 148.37
2021-07-01 VAN ZUILEN WILFRED Pres, Europe, M. East & Africa A - A-Award Employee Stock Option (right to buy) 40208 161.94
2021-07-01 VAN ZUILEN WILFRED Pres, Europe, M. East & Africa A - A-Award Restricted Stock Units 10215 0
2021-06-30 MICHELSON MICHAEL W director A - A-Award Phantom Stock Units 170.882 160.93
2021-06-30 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 85.441 160.93
2021-06-30 Jafry Syed A. director A - A-Award Phantom Stock Units 85.441 160.93
2021-06-30 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 201.951 160.93
2021-05-20 HIGGINS ARTHUR J director D - G-Gift Common Stock 1000 0
2021-06-30 Hilado Maria Teresa director A - A-Award Phantom Stock Units 170.882 160.93
2021-06-30 HAGEMANN ROBERT director A - A-Award Phantom Stock Units 209.719 160.93
2021-06-30 Farrell Michael J. director A - A-Award Phantom Stock Units 194.184 160.93
2021-06-30 BERNARD BETSY J director A - A-Award Phantom Stock Units 194.184 160.93
2021-06-30 BEGLEY CHRISTOPHER B director A - A-Award Phantom Stock Units 256.323 160.93
2021-07-01 Upadhyay Suketu Exec. VP, CFO D - M-Exempt Restricted Stock Units 3655 0
2021-07-01 Upadhyay Suketu Exec. VP, CFO A - M-Exempt Common Stock 3655 0
2021-07-01 Upadhyay Suketu Exec. VP, CFO D - F-InKind Common Stock 1112 161.94
2021-06-01 VAN ZUILEN WILFRED officer - 0 0
2021-05-14 MICHELSON MICHAEL W director A - A-Award Phantom Stock Units 500 166.87
2021-05-14 MICHELSON MICHAEL W director A - A-Award Restricted Stock Units 779.05 0
2021-05-14 Kolli Sreelakshmi director A - A-Award Restricted Stock Units 779.05 0
2021-05-14 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 500 166.87
2021-05-14 Jafry Syed A. director A - A-Award Restricted Stock Units 779.05 0
2021-05-14 Jafry Syed A. director A - A-Award Phantom Stock Units 500 0
2021-05-14 Hilado Maria Teresa director A - A-Award Phantom Stock Units 500 166.87
2021-05-14 Hilado Maria Teresa director A - A-Award Restricted Stock Units 779.05 0
2021-05-14 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 500 166.87
2021-05-14 HIGGINS ARTHUR J director A - A-Award Restricted Stock Units 779.05 0
2021-05-14 HAGEMANN ROBERT director A - A-Award Phantom Stock Units 500 166.87
2021-05-14 HAGEMANN ROBERT director A - A-Award Restricted Stock Units 779.05 0
2021-05-14 Farrell Michael J. director A - A-Award Phantom Stock Units 500 166.87
2021-05-14 Farrell Michael J. director A - A-Award Restricted Stock Units 779.05 0
2021-05-14 BERNARD BETSY J director A - A-Award Restricted Stock Units 779.05 0
2021-05-14 BERNARD BETSY J director A - A-Award Phantom Stock Units 500 166.87
2021-05-14 BEGLEY CHRISTOPHER B director A - A-Award Phantom Stock Units 500 166.87
2021-05-14 BEGLEY CHRISTOPHER B director A - A-Award Restricted Stock Units 779.05 0
2021-05-06 HIGGINS ARTHUR J director A - P-Purchase Common Stock 1000 171.58
2021-05-01 Ellingson Rachel SVP & Chief Strategy Officer A - M-Exempt Common Stock 515 0
2021-05-01 Ellingson Rachel SVP & Chief Strategy Officer D - F-InKind Common Stock 162 177.27
2021-05-01 Ellingson Rachel SVP & Chief Strategy Officer D - M-Exempt Restricted Stock Units 515 0
2021-04-01 Winkler Lori SVP and CHRO A - A-Award Employee Stock Option (right to buy) 3988 159.47
2021-03-31 MICHELSON MICHAEL W director A - A-Award Phantom Stock Units 169.785 161.97
2021-03-31 Kolli Sreelakshmi director A - A-Award Phantom Stock Units 84.893 161.97
2021-03-31 Jafry Syed A. director A - A-Award Phantom Stock Units 84.893 161.97
2021-03-31 Hilado Maria Teresa director A - A-Award Phantom Stock Units 169.785 161.97
2021-03-31 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 200.655 161.97
2021-03-31 HAGEMANN ROBERT director A - A-Award Phantom Stock Units 208.372 161.97
2021-03-31 Farrell Michael J. director A - A-Award Phantom Stock Units 169.785 161.97
2021-03-31 BOUDREAUX GAIL director A - A-Award Phantom Stock Units 169.785 161.97
2021-03-31 BERNARD BETSY J director A - A-Award Phantom Stock Units 192.937 161.97
2021-03-31 BEGLEY CHRISTOPHER B director A - A-Award Phantom Stock Units 192.937 161.97
2021-03-22 Winkler Lori SVP and CHRO D - Common Stock 0 0
2021-03-22 Winkler Lori SVP and CHRO D - Restricted Stock Units 543 0
2021-03-22 Winkler Lori SVP and CHRO D - Employee Stock Option (right to buy) 3150 137.02
2021-03-22 Winkler Lori SVP and CHRO D - Employee Stock Option (right to buy) 6218 163.79
2021-02-26 Yi Sang President, Asia Pacific A - M-Exempt Common Stock 338 0
2021-02-26 Yi Sang President, Asia Pacific D - M-Exempt Restricted Stock Units 338 0
2021-02-26 Tornos Ivan Grp Pres Global Bus & Americas A - M-Exempt Common Stock 517 0
2021-02-26 Tornos Ivan Grp Pres Global Bus & Americas D - F-InKind Common Stock 205 163.92
2021-02-26 Tornos Ivan Grp Pres Global Bus & Americas D - M-Exempt Restricted Stock Units 517 0
2021-02-26 Phipps Chad F Sr. VP/Gen Counsel/Secretary A - M-Exempt Common Stock 310 0
2021-02-26 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - F-InKind Common Stock 106 163.92
2021-02-26 Phipps Chad F Sr. VP/Gen Counsel/Secretary D - M-Exempt Restricted Stock Units 310 0
2021-02-26 Hanson Bryan C President and CEO A - M-Exempt Common Stock 1866 0
2021-02-26 Hanson Bryan C President and CEO D - F-InKind Common Stock 585 163.92
2021-02-26 Hanson Bryan C President and CEO D - M-Exempt Restricted Stock Units 1866 0
2021-02-26 Ellingson Rachel SVP & Chief Strategy Officer A - M-Exempt Common Stock 156 0
2021-02-26 Ellingson Rachel SVP & Chief Strategy Officer D - F-InKind Common Stock 58 163.92
2021-02-26 Ellingson Rachel SVP & Chief Strategy Officer D - M-Exempt Restricted Stock Units 156 0
2021-02-26 Deltort Didier President, EMEA A - M-Exempt Common Stock 315 0
2021-02-26 Deltort Didier President, EMEA D - M-Exempt Restricted Stock Units 315 0
2021-02-25 Yi Sang President, Asia Pacific A - A-Award Employee Stock Option (right to buy) 24305 163.79
2021-02-25 Upadhyay Suketu Exec. VP, CFO A - A-Award Employee Stock Option (right to buy) 33914 163.79
2021-02-25 Tornos Ivan Grp Pres Global Bus & Americas A - A-Award Employee Stock Option (right to buy) 36175 163.79
2021-02-25 Phipps Chad F Sr. VP/Gen Counsel/Secretary A - A-Award Employee Stock Option (right to buy) 22044 163.79
2021-02-25 Nichol Carrie Ann VP, Controller & CAO A - A-Award Employee Stock Option (right to buy) 5088 163.79
2021-02-25 Hanson Bryan C President and CEO A - A-Award Employee Stock Option (right to buy) 131698 163.79
2021-02-25 Ellingson Rachel SVP & Chief Strategy Officer A - A-Award Employee Stock Option (right to buy) 8479 163.79
2021-02-25 Deltort Didier President, EMEA A - A-Award Employee Stock Option (right to buy) 17749 163.79
2021-02-18 Yi Sang President, Asia Pacific A - A-Award Restricted Stock Units 338 0
2021-02-18 Tornos Ivan Grp Pres Global Bus & Americas A - A-Award Restricted Stock Units 517 0
2021-02-18 Phipps Chad F Sr. VP/Gen Counsel/Secretary A - A-Award Restricted Stock Units 310 0
2021-02-18 Hanson Bryan C President and CEO A - A-Award Restricted Stock Units 1866 0
2021-02-18 Ellingson Rachel SVP & CSO A - A-Award Restricted Stock Units 156 0
2021-02-18 Deltort Didier President, EMEA A - A-Award Restricted Stock Units 315 0
2021-02-18 Kolli Sreelakshmi - 0 0
2021-01-04 Ellingson Rachel SVP & CSO D - Common Stock 0 0
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2021-01-04 Ellingson Rachel SVP & CSO D - Employee Stock Option (right to buy) 12015 123.73
2021-01-04 Ellingson Rachel SVP & CSO D - Employee Stock Option (right to buy) 10942 157.54
2021-01-04 Ellingson Rachel SVP & CSO D - Restricted Stock Units 1030 0
2020-12-31 Hilado Maria Teresa director A - A-Award Phantom Stock Units 179.891 152.87
2020-12-31 MICHELSON MICHAEL W director A - A-Award Phantom Stock Units 179.891 152.87
2020-12-31 Jafry Syed A. director A - A-Award Phantom Stock Units 89.946 152.87
2020-12-31 HIGGINS ARTHUR J director A - A-Award Phantom Stock Units 212.599 152.87
2020-12-31 HAGEMANN ROBERT director A - A-Award Phantom Stock Units 220.775 152.87
2020-12-31 Farrell Michael J. director A - A-Award Phantom Stock Units 179.891 152.87
2020-12-31 BOUDREAUX GAIL director A - A-Award Phantom Stock Units 179.891 152.87
2020-12-31 BERNARD BETSY J director A - A-Award Phantom Stock Units 204.422 152.87
2020-12-31 BEGLEY CHRISTOPHER B director A - A-Award Phantom Stock Units 204.422 152.87
2020-12-19 Hanson Bryan C President and CEO A - M-Exempt Common Stock 8625 0
2020-12-19 Hanson Bryan C President and CEO D - F-InKind Common Stock 3997 150.97
2020-12-19 Hanson Bryan C President and CEO D - M-Exempt Restricted Stock Units 8625 0
2020-12-03 Tornos Ivan Grp Pres Global Bus & Americas A - M-Exempt Common Stock 1524 0
2020-12-03 Tornos Ivan Grp Pres Global Bus & Americas D - F-InKind Common Stock 812 147.07
2020-12-03 Tornos Ivan Grp Pres Global Bus & Americas A - M-Exempt Common Stock 925 0
2020-12-03 Tornos Ivan Grp Pres Global Bus & Americas A - M-Exempt Common Stock 1089 0
2020-12-03 Tornos Ivan Grp Pres Global Bus & Americas D - F-InKind Common Stock 493 147.07
2020-12-03 Tornos Ivan Grp Pres Global Bus & Americas D - F-InKind Common Stock 580 147.07
2020-12-03 Tornos Ivan Grp Pres Global Bus & Americas D - M-Exempt Restricted Stock Units 1524 0
2020-12-03 Tornos Ivan Grp Pres Global Bus & Americas D - M-Exempt Restricted Stock Units 1089 0
2020-12-03 Tornos Ivan Grp Pres Global Bus & Americas D - M-Exempt Restricted Stock Units 925 0
2020-11-18 Yi Sang President, Asia Pacific D - S-Sale Common Stock 1200 152.59
2020-11-09 Phipps Chad F Sr. VP/Gen Counsel/Secretary A - M-Exempt Common Stock 30040 60.1
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Transcripts
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet Second Quarter 2024 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today, August 7, 2024. Following today's presentation, there will be a question-and-answer session. At this time, all participants are in a listen-only mode. [Operator Instructions] I would now like to turn the conference over to Zach Weiner, Director of Investor Relations. Please go ahead.
Zach Weiner:
Thank you, operator, and good morning, everyone. Welcome to Zimmer Biomet's second quarter 2024 earnings conference call. Joining me on today's call are Ivan Tornos, our President and CEO; and CFO and EVP, Finance, Operations, and Supply Chain, Suky Upadhyay. Before we get started, I would like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by the forward-looking statements due to a variety of risks and uncertainties. Please note, we assume no obligation to update these forward-looking statements, even if actual results or future expectations change materially. Please refer to our SEC filing for a detailed discussion of these risks and uncertainties in addition to the inherent limitations of such forward-looking statements. Additionally, the discussions on this call will include certain non-GAAP financial measures, some of which are forward-looking non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures and an explanation of our basis for calculating these measures is included within our second quarter earnings release, which can be found on our website, zimmerbiomet.com. With that, I'll turn the call over to Ivan. Ivan?
Ivan Tornos:
Thank you, Zach. Thank you, everyone, for joining today's call. Good morning. I would like to start the way that I usually do, by taking a quick moment to show my sincere gratitude to the north of 18,000 Zimmer Biomet team members across the world, who each and every day go above and beyond in delivering on our mission, elevating pain and improving the quality of life for people around the world. That's what you and I get to do each and every day, and you're doing an unreal job in bringing this mission into action. Thank you for your commitment to Zimmer Biomet, thank you for your tireless work, and thank you for the very strong performance so far in this year 2024. We are now past the midpoint in the year and we're growing 5% after having delivered strong performances in 2023, 2022, and 2021. So the trend is real, the performance is there, and I'm deeply proud of the work that you're doing daily. As I've said countless times, the Zimmer Biomet workforce and our culture here is truly one of our key competitive advantages. In today's call, I'm going to give some opening remarks and then Suky will cover financials. And then, as always, we will leave ample time to answer your questions. The agenda for today, first, I'll cover some perspective on the quarter. Secondly, I'll discuss the drivers of our performance and why we are even more confident than ever in our updated full year guidance for 2024 and why, already looking into 2025 and beyond, we're also very confident that we'll continue to deliver on the long-range plan commitments that we outlined at the end of May at our first ever Zimmer Biomet Investor Day. Recall, those commitments were driving revenue growth at least at mid-single digit growth rates, driving EPS at 1.5 revenue growth, and driving free cash flow growth at least 100 basis points above our EPS commitments. The third thing in the agenda, we'll close with our strategic priorities, those being people and culture, operational excellence, and innovation and diversification. Starting with our Q2 results, we continue to be very encouraged by our global performance. In the second quarter of this year 2024, we grew 5.6% on a constant currency basis. And with that, we have now closed the first half of 2024, growing 5%. Worth noting that this 5% is versus very tough comps in the first half of 2023. The second quarter of 2024 now marks the 10th consecutive quarter in which Zimmer Biomet has grown mid-single digit or above. So, again, a trend in the making that is real, and we're very confident that this performance will continue, if not will accelerate as we continue to move our business forward. Against the backdrop, in the quarter, we did see some weakness early in the first half of the quarter in the U.S. It's worth noting that May and June here in the U.S. were better than April. And in July, the U.S. Recon business actually delivered mid-single digit growth. So, choppiness through the first half of the quarter and then an improvement through the second half, which has continued with very strong performance through the month of July. Our OUS international business, outside the U.S. business, has delivered above expectations. We saw a strong demand in the key markets across both Recon and the S.E.T. categories. So, overall, very diversified, solid performance coming out of these markets. I love the fact that in Q2, in our second quarter, we continued to deliver excellent performance in our other category. This category is primarily focused on enabling technologies, primarily ROSA. We saw a strong demand for ROSA, growing double digit in that business and we also saw strong demand in enabling technologies and navigation systems. As we have been saying for quite some time, we want to be more than just a leading reconstructive knees and hips company in key geographies, where we have a really high market share, as an example, the U.S. or key countries of Europe and Asia Pacific. One example of this diversification journey has been S.E.T. We've been committing to growing S.E.T. at least mid-single digit and Q2 of 2024 is now the third quarter in a row in where we are growing mid-single digit or above, a trend that we expect to continue towards the end of 2024 and moving into 2025 and 2026. So, nice growth in other, nice growth in international, and nice growth in S.E.T. One area that I'll tell you we've made significant strides is within our hips portfolio. We did lose some market share in hips in the U.S. and OUS markets over the last three years to five years. And as I said over and over, this was due to lacking three key product items, direct anterior stems -- what we call triple taper stems, elegant navigation, and surgical impactors. As we sit here today, we have remediated those gaps. We have 510(k) approval for Z1 or triple taper stem. We are regaining market share already with HAMMR, or surgical impactor. And today, we have the most comprehensive navigation in hip arthroplasty. Not only do we have ROSA Hip, we also have the only 510(K) FDA-cleared augmented/mixed reality hip navigation platform via a partnership with our colleagues at Hip Insights. And now, we have also signed and announced an agreement to acquire OrthoGrid that is going to give us a leading position in navigation using artificial intelligence devices. So we have the most comprehensive suite of solutions in navigation, in direct anterior stems, and in surgical impactors, not to mention having the best core implant technology with products like G7 and Avenir Complete. So the expectation is to grow again above market when it comes to hips and regain some of the market share that we lost over the last three years or five years. Moving from hips, we have developed and we are today the first and only robotic-assisted shoulder replacement platform in the world. The feedback on the cases we've done with ROSA Shoulder continues to be very compelling, and as we enter late Q3 and early Q4, we expect to see an acceleration of those cases. And in 2025, we expect ROSA Shoulder to be a very meaningful growth driver for Zimmer Biomet. We recently announced the partnership with THINK Surgical. This is going to provide our surgeon customers optionality across the robotic landscape. We have conducted extensive training, with one voice on customer, and the feedback on this partnership with THINK remains super. With this partnership, Zimmer Biomet is the only orthopedic company in the world that will offer both a handheld CT scan-based system in the TMINI, exclusive for Zimmer Biomet platform, as well as a simplified, CT scan-less robotic system in our current form factor of ROSA for total knee arthroplasty. We're excited about the optionality and we're also excited about the fact that we continue to innovate at a very fast pace when it comes to ROSA and we're expecting to launch at least three new ROSA modalities in the next three quarters to eight quarters. From an earnings standpoint, we generated $2.01 of adjusted earnings per share in the quarter or a growth of 10%. This is in line with our long-range plan targets I outlined at our Investor Day in May. Inside of the strong performance through the first half of the year, the team continues to execute on the three strategic priorities that I keep outlining in each and every earnings call and at every Zimmer Biomet meeting around the world. The three priorities of people and culture, foundational to everything that we do; operational excellence; and innovation and diversification. As I said in my opening, people and culture continues to be a key competitive advantage for Zimmer Biomet. I'm proud to share that Zimmer Biomet was recently named one of America's Best Midsize Companies to work for by TIME magazine. This reflects the strength in team member satisfaction and engagement, our revenue growth profile, and the turnaround of the organization now behind us. On the second imperative, operational excellence, we continue to expect to grow constant currency revenue at least at mid-single digit level, with adjusted earnings per share growing at least 1.5 times revenue, and free cash flow growing at least 100 basis points faster than earnings. It's a commitment that we're making not just for 2024, but also for the long-range plan 2025, 2026, and beyond. This is a mindset that continues to proliferate throughout the organization. We pay people on delivering towards such commitments. We have trained people to deliver on those commitments and the trend, as I've repeated a few times in my opening remarks, is in the making. In the past, when it comes to innovation and diversification, it's been very much portfolio-centric, moving from lower-growth markets to higher-growth markets, point in case, the super performance in S.E.T. But today, we're also thinking diversification from a geographic mix standpoint. We want to continue to invest in key markets outside of the U.S. where we see an opportunity to deliver sustainable revenue and profit growth. We're encouraged by the sound performance that we've seen in our OUS business and we expect to continue to accelerate growth in these markets without compromising our margin performance. In conclusion, we are very proud of how far we have come as an organization in terms of the financial progress, the innovation progress, and the commercial execution. Our second quarter results are another proof point that we make commitments and deliver on those commitments, and we fully expect that the trend is going to continue for the balance of the year and beyond. We're confident in our guidance for the year and we love the fact that we're impacting the lives of millions of people, and I'm deeply inspired every day in knowing that my teammates and I are living the Zimmer Biomet mission of alleviating pain and improving the quality of life for people around the world. With that, I'll turn the call over to Suky. Thank you.
Suky Upadhyay:
Thank you, and good morning, everyone. As Ivan mentioned, Q2 closed a solid first half of the year for Zimmer Biomet, with ex FX revenue growth of 5% in the first half and operating margins well ahead of the prior year. Our results through the quarter provide increased confidence in our 2024 full year guidance, which includes 5% to 6% constant currency revenue growth and $8.00 to $8.15 in adjusted earnings per share. I'll provide more color on guidance shortly. Moving to the second quarter results. Unless otherwise noted, my statements will be about the second quarter of 2024 and how it compares to the same period in 2023, and my commentary will be on a constant currency and adjusted operating basis. Net sales were $1.942 billion, an increase of 3.9% on a reported basis and an increase of 5.6% excluding the impact of foreign currency. As a reminder, we had a day rate tailwind that impacted all businesses and regions at about the same level. Pricing at a consolidated level was 80 basis points, driven by gains in international that were partially offset by modest declines in the U.S. Our U.S. business grew 3.5% and international grew 8.5%. Growth in the U.S. was driven by our S.E.T. and other categories. As a reminder, our other category includes our surgical business, as well as enabling technologies such as ROSA capital sales. Our international business continues to perform well, driven by knee and S.E.T., with continued strength in emerging markets. Global knees grew 5.5% in the quarter, with U.S. growing 0.8% and international growing 11.5%. U.S. growth was impacted by softer sales in the first part of the quarter, with improvement in utilization and growth as we move through the second half. We continue to see strong uptake of Persona OsseoTi and remain optimistic that the recent robust ROSA installs will continue to drive pull-through and share of wallet opportunities. International continues to benefit from ROSA Robotics, as well as our Persona family of implants. Global hips grew 2.8% in the quarter, with the U.S. growing 1.8% and international growing 3.7%. While our hip business has lagged the broader market due to key portfolio gaps, we have made significant progress with new product introductions and are excited to get back on the offensive in early 2025 when these products and technologies are fully in market. Next, the S.E.T. category grew 7.3%, led by our key focus areas of CMFT, upper extremities, and sports, growing on average high-single digits. All other categories grew mid-single digits on average, giving us confidence in our ability to drive mid-single digit growth or better from S.E.T. through the second half of the year. Finally, our other category grew 11.3% in the quarter and continues to be driven by strong demand for ROSA systems and other enabling technologies. Turning to our P&L. We reported GAAP diluted earnings per share of $1.18 compared to GAAP diluted earnings per share of $1 in the prior year. Higher revenue combined with lower R&D, effective tax rate, and share count more than offset expenses associated with our restructuring program. On an adjusted basis, we delivered diluted earnings per share of $2.01 compared to $1.82 in the prior year, representing over 10% growth. The step-up was primarily driven by revenue growth, improved operating margins due to savings pull-through from our restructuring program, and a lower share count, partially offset by a higher tax rate. Adjusted gross margin was 71.6%, about 40 basis points lower than the prior year, driven by higher manufacturing costs, partially offset by better pricing and lower royalties. Adjusted operating margin was 28.5%, up 100 basis points from the prior year. The increase in operating margin was driven by higher revenue and lower OpEx as a percentage of sales as a result of our restructuring program. Net interest and other adjusted non-operating expenses were $45 million in the quarter, and our adjusted tax rate was 18.2%. Turning to cash and liquidity. We generated operating cash flows of $369 million, free cash flow of $251 million, and we ended the quarter with $420 million of cash and cash equivalents. Aligned with our capital allocation strategies, we repurchased $95 million of shares in the second quarter. Regarding our outlook for the rest of the year, we are reiterating our full year constant currency revenue growth guidance of 5% to 6%, but given further strengthening of the U.S. dollar, we are updating our reported revenue growth to 4% to 5% and now expect 100 basis points of currency headwind for the full year, which should impact Q3 more than Q4. We still expect to generate between $8.00 and $8.15 in adjusted earnings per share despite this greater FX pressure and $1.05 billion to $1.1 billion in free cash flow. Our tax and interest and non-operating expenses expectations remain unchanged. When thinking about the cadence through the second half of the year, due to normal seasonality, Q3 typically is the lowest revenue quarter from a dollar perspective, with Q4 being the highest. From a margin standpoint, we still expect gross margin to step down sequentially as the year progresses, while operating margins should expand by more than 50 basis points year-over-year. As usual, we expect operating margin to be higher in Q4 than Q3, driven by higher revenue. In summary, Q2 closed a positive first half of the year, giving us continued confidence in our ability to meet our full year outlook and another positive proof point through our LRP. With that, I'll turn the call back over to Zach.
Zach Weiner:
Thanks, Suky. Before we start the Q&A session, just a quick reminder to please limit yourself to a single question and one brief follow-up, so we can get through as many questions as possible during the call. With that, operator, may we have the first question, please?
Operator:
Thank you. We'll go first to David Roman with Goldman Sachs.
David Roman:
Thank you, and good morning, everybody. I wanted just to start with the U.S. knee business and appreciate the comments around the month-to-month fluctuations in growth. But maybe you could just take a step back and help us think through the impact of the conversion to cementless and cementless robotic? How is that tracking? And how should we think about the way that shows up in reported numbers?
Ivan Tornos:
Thank you, David. Good morning. Maybe quickly here, 20 seconds big picture, and then I'll talk about the U.S. So, big picture. It was a good quarter. We here at Zimmer Biomet deliver 5.6% ex-FX. As I noted in my prepared remarks, this is the 10th quarter in a row growing mid-single digit or above. And we're pleased with the double-digit growth in adjusted EPS. S.E.T. performed above expectations, third quarter mid-single digit or above. I'm pleased to report that for the first time in a while, every single business within S.E.T. -- and there are six of them, actually grew, which is something we didn't see before. Enabling technologies, which is robotics primarily, grew double digit in Q2. It grew double digit in Q1. The U.S. grew -- robotics grew 16% in the quarter, so strong in that regard. And as we announced this morning, we did close the gaps in hips that we had, which frankly is one of the reasons why we lost market share. Just throwing the summary to highlight the fact that unlike five years ago, we're not just a U.S. knee-centric type of company. That said, relative to knees and the U.S. performance, look, David, not pleased with the quarter. It was softer than expected. And what I will tell you is that there are three main reasons why we did not do better in the U.S., and these are solvable reasons. The first one is, we had a large amount of high volume surgeons -- Zimmer Biomet high volume surgeons that were out of the territory for a variety of reasons. We hosted large medical education events and we did have a large group of surgeons that were not performing surgeries in the quarter. The second piece is that we had some challenges from a supply standpoint when it came to one of our knee platforms, what we call limb salvage, which is part of knee revision cases. These are high ASP cases. And candidly, this didn't help the quarter. And then the third reason on why knees in the U.S. was softer than expected is comps. We delivered knee growth of 10% -- almost 10%, 9.8% to be exact in Q2 of 2023, which was close to mid-single digit, and the U.S. grew 5%. So, comps didn't help. So, in the background of those surgeons being out, supply constraints, the comps didn't help out. What I will tell you is that these three elements have gotten resolved as we move out of the quarter and sitting here, July behind us, the U.S. Recon performance is very strong. On the second part of your question, David, cementless continues to track very nicely. Candidly, I hope we can get more sets out. The adoption rate is very high. We are converting accounts and we hope to have cementless not just in the U.S., but outside of the U.S. very soon. So that's the summary of what's happening here in the U.S.
David Roman:
That's -- thank you for all the detail. It's super helpful. Maybe, Suky, just a quick follow-up for you on the P&L. Can you help us think about the kind of interplay here between the benefits you're seeing from the restructuring? And I think you had talked about planning to reinvest some of the savings. Where are you in sort of the progress with respect to the restructuring benefit, and then at the same -- on the -- at the same token, kind of that level of reinvestment that you had contemplated when you introduced the restructuring back in February?
Suky Upadhyay:
Yes. First of all, good morning, David. Thanks for the question. Just to remind everyone, we talked about or announced our restructuring program at the early part of this year. We talked about $200 million of run rate savings as we exit 2025. I would say where we are right now is we're slightly ahead of that overall trend, at least from a timing perspective, still expect to generate $200 million on a run rate, but it's happening probably a little bit faster than we originally expected. That's definitely contributing to operating margin expansion. You see that in the second quarter, where we're up 100 basis points year-over-year. So, very nice progress there. And that's in the backdrop of continuing to invest in R&D, as well as in certain areas across commercial, whether that's building specialized sales forces across S.E.T., additional complement in our technology, components of Recon and other parts of commercial. So we are, as I would say, just summarizing, going a little bit faster than expected on the savings program, and we're in line and on track with that reinvestment plan.
Zach Weiner:
Thanks, David. Can we go to the next question, please, Katie?
Operator:
Thank you. We'll go next to Matt Taylor with Jefferies.
Matt Taylor:
Hi, guys. Thanks for taking the question. I guess, I just wanted to ask you more about the hip progress that you're expecting, calling out the opportunity to move back into a share-taking position over the next couple of years and tying that back to the Analyst Day goal. So, I guess, I'll ask the question as to when you expect this to really start and how we should measure your progress against the share gain goals? And are there inflection points along the way that we should be looking out for in your hip business?
Ivan Tornos:
Thank you, Matt. The short answer was we have already started. So again, July, so far so good when it comes to hip recovery. We launched our surgical impactor HAMMR midpoint into Q2 and the adoption has been great so far. As you heard from us, we will be launching our triple taper stem, that's Z1, which is going to enable share regaining in direct anterior. That's going to get launched late in Q3, early Q4. We have the quantity that we need. We got the commercial plans in place. So, that should be another driver. And the third leg was to have elegant navigation systems, and we got three of them. This morning, we announced the acquisition of OrthoGrid. That should close later in the year. It's one of the fastest growing navigation platforms in the U.S. So I would say the combination of triple taper stems, surgical impactors, and three different modalities of navigation put us in a position to regain market share in the U.S. and outside of the U.S. Outside of the U.S., we're going to be launching a second generation of robotics, hip posterior robotics, and that's another driver of share regaining. So we're very confident about where we are today and we will get the share back.
Matt Taylor:
Great. And just one clarification. So, the issues you mentioned in the U.S., you're basically saying those are temporary, related to the surgeons being out, the supply issue, not a change in the market or something else bigger happening?
Ivan Tornos:
The market is very strong. By now, all of us have reported. So you see that the market growth rates remain above pre-pandemic levels. So, nothing relative to market. And again, I just want to emphasize that the two, three things that I talked about, the large volume surgeons being out of the territory, we saw in July a recovery. On the revision constraints, those are largely soft, and again, that's one portion of our platform. And again, so far so good. So yes, market is healthy.
Zach Weiner:
Thanks, Matt. Katie, could we have the next question?
Operator:
We'll go next to Drew Ranieri with Morgan Stanley.
Drew Ranieri:
Hi, Ivan and Suky. Thanks for taking the questions. Maybe, Suky, for you to start. Just you've talked more -- you've talked about growth and margin improvement and increasingly so about free cash flow. But when we kind of look at your guide for the year, it still implies a significant step-up in the back half versus the first half. I guess, some of that would be growth in the leverage opportunity that you kind of talked about. But is the environment supportive enough to see kind of a meaningful working capital improvement and, especially, with all these new products coming and I have to imagine you're going to be spending on FX, but just -- or on CapEx. But just how do you kind of get to your free cash flow guide and your plans on using that cash this year?
Suky Upadhyay:
Yes. First of all, good morning, Drew. Thanks for the question. There are really three building blocks to the growth in free cash flow from where we start here in the second quarter -- or third quarter, I should say. And by the way, the asymmetry between first half and second half of free cash flow is typical in our business. The three building blocks are, really, you have a lot of headwinds in the first half of the year related to rebates from the previous year fourth quarter that you have to pay in the first quarter, bonuses and different levels of incentive payments that happened in the first half. So there are certain headwinds that typically happen in the first half that don't repeat in the second half. In addition, in the second half, you're going to have improved EBITDA through growth as you pointed out. But secondly, a pretty meaningful improvement in working capital, specifically around inventory. We've already seen that inventory improve from second quarter versus first quarter, and we're going to continue to see that sequentially improve in the third quarter, fourth quarter as well. So that's a pretty big driver of the overall free cash flow generation and step-up into the second half of the year. Relative to where we're prioritizing, we continue to prioritize in making sure that we've got the right assets and the right level of investment on our organic business. As Ivan talked about, we're actually stepping up our instrument CapEx around OsseoTi. Demand, quite frankly, has outstripped our original expectations and -- which is a great thing, and we're now catching up on getting those sets out into market. And so, we feel really good about that and we're actually putting more dollars against that. But outside of that, I think what you're seeing also is that we bought some shares back in the second quarter, aligned to our overall capital allocation strategy, which we outlined on our Investor Day. So, overall, feel good about where we're headed for cash for the full year. You will see a second half step-up, typical in every year, and we're going to continue to prioritize our organic investments. And then from there, our capital allocation remains balanced between M&A and return of capital to shareholders.
Drew Ranieri:
Got it. Thanks, Suky. And Ivan, maybe just over to you quickly on the OrthoGrid acquisition. Can you just talk a little bit more about how this supports the overall large joint strategy and maybe how you think this platform could evolve over time across the portfolio or care settings and maybe eventually into the S.E.T. business? Thanks for taking the questions.
Ivan Tornos:
Thank you, Drew. Very excited. So this one word is optionality. Now, Zimmer Biomet is the only company in the world with three different forms of navigation. With ROSA Hip, you got anterior today, robotic navigation, at some point soon posterior as well. With OrthoGrid, we have AI surgical guidance. It's a lighter, faster option for some of the surgeons that want to use a non-robotic option. And then the third vector here, as you know, we have a partnership with Hip Insights, which is the only FDA-approved mixed/reality navigation, and that pretty much gives the surgeon X-ray vision over the patient's anatomy, instruments, and implants. So, again, a different modality, which some customers seem to like. So we got three different ways to do navigation and that appeals to pretty much every customer in that regard. We -- the broader strategy, we want to be a company that delivers faster, better solutions, and navigation is an enabler of that. And again, in the big picture, this will enable Zimmer Biomet to regain some of those 200 basis points to 300 basis points of market share that we lost over the years.
Zach Weiner:
Thanks, Drew. Can we have the next question, Katie?
Operator:
Thank you. We'll go next to Joanne Wuensch with Citi.
Joanne Wuensch:
Good morning, and thank you for taking the questions. You mentioned somewhere in the script several new ROSA robots that you expect over the next three quarters to eight quarters. Could you remind us of how many is several and which those are and how we should think about those launching over essentially the next two years? And I'll throw one more in there for Suky. How do you think about the revenue contribution from those robots ramping? Thank you.
Suky Upadhyay:
Hi, Joanne, good to talk to you. Good morning. I think I said over the next four quarters to eight quarters, but if it is three, let's keep it to four. We're not going to get into a lot of details, given competitive reasons. But what we are committed to launch is a posterior application for some of the OUS markets, where posterior is more prevalent than interior. As you know, we're going to get into full launch mode for ROSA Shoulder later in the year. And again, so far, the voice of customer has been super. We want to get at some point a different version of ROSA. We're launching two different ROSAs for knees. One is going to be late this year, early 2025. We call it ROSA [B15], which has different levels of workflows, smart positioning, it's got a different auto-balance procedure, and it will be a platform that is going to deliver a kinematic aligned type of knee. In 2025, at some point, we will have a ROSA CT scan base for some of our ROSA users that like that type of device. So those are four or five examples of what's coming here again over the next four quarters to eight quarters. In addition to ROSA, we have the partnership with THINK Surgical. And we got, as I just mentioned, very comprehensive navigation systems. In terms of the revenue contribution, we don't really give details on that. What I will tell you is that we're growing today, end of Q2 double digit in the U.S., when it comes to enabling technologies, we grew double digit in Q1 and we don't expect that to slow down, and that's pull-through for implants.
Joanne Wuensch:
Perfect. Thank you so much.
Ivan Tornos:
Thank you, Joanne.
Zach Weiner:
Thanks, Joanne. Can we have the next question?
Operator:
We'll go next to Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
Good morning. Thanks for taking the question. One for Ivan and one for Suky. I'll try to ask them both upfront. So, Ivan, I'd love to hear an update on the status of Persona IQ, the launch and the short -- have you launched the short stem extension and how that could help and the TPT, we saw you applied for that. Just confident you'll get it and what that could mean for adoption of? Just as my follow-up for Ivan on the gross margin here -- I mean, I'm sorry, for Suky. I -- the gross margin was a little lighter than expected in Q2. What's assumed for the full year? Did you say that gross margin steps down as the year progresses? So, Q3 lower than Q2 and Q4 lower than Q3, and is gross margin still expected to be in line with 2023? I think that was the prior guidance. So, I apologize, Suky, if I heard incorrectly your comments earlier. But thanks for taking the questions.
Ivan Tornos:
Hi, thank you, Larry. First part of your question on Persona IQ, we remain excited. The adoption is speeding up. We should see some acceleration in the second half of 2024, part of the new product contribution for 2024 and in a more meaningful way in 2025. We've now crossed 3 billion data points around range of motion, mobility and what not. We launched what we call Recovery Curves, which enables the opportunity for us to cross-reference how certain patients are performing versus others. We're going to be having a data discussion with payers so that we can engage in some risk-sharing type of agreements. So, again, leveraging the data. On the stubby part of your question, we're going to be launching that at the -- full launch at the end of 2024. So we got the approval. The design is ready to go, the sets are ready to go. And again, that's part of the acceleration in the second half of 2024, more meaningfully in 2025. We've now signed agreements, partnerships with some of the major hospitals around the U.S. And then in terms of TPT, we did look at it. We engaged a third-party consultant. We pulled the TPT application, because it didn't make economic sense. It didn't make as much economic sense as we thought. And again, we believe there are different, better ways to monetize the technology. We still have NTAP, but TPT didn't make sense.
Suky Upadhyay:
Yes. Good morning, Larry. On your questions on gross margin, I think, actually, you largely got it right, but let me just step back and go through it for you. Just year-over-year overall, we expect gross margins to be in line with '23, but potentially slightly down. That's the new element there and that's largely driven by the mix of our business. We're just seeing much stronger international sales, which have a lower gross margin than the U.S. So, it's really mix related. But again, in line to potentially slightly down. In the second quarter, you're right, it was a little bit lighter than our expectation, again, back to that mix component where the U.S. was just much stronger from a growth perspective than the U.S. for all the reasons that Ivan spoke about. Even in the backdrop of that, Larry, we still managed to expand operating margin by 100 basis points and grow earnings quite nicely. On the cadence, you got it right, and it's consistent with everything that we provided earlier this year, which is to say gross margin will step down sequentially in the second half versus the first half. And you should see that also Q2 to Q3, Q3 to Q4 sequentially down. The primary driver of that, again, going back to our earlier comments from this year, are really around the inflationary pressure we saw in third-party manufacturing costs in 2023. That got capitalized and are now feathering into the P&L throughout this year. So that's the driver of the cadence there. But again, I'll just revert you back to the backdrop of all that is we do still expect to see operating -- meaningful operating margin expansion for the full year and we do expect to see operating margin in the second half step up versus the first half, again, driven by the restructuring program despite the sequential lowering of gross margin. So I'm sorry for all the detail there, but I wanted to get it all out in sort of one compact commentary.
Larry Biegelsen:
Thank you.
Zach Weiner:
Thanks, Larry. Katie, can we have the next question, please?
Operator:
We'll go next to Ryan Zimmerman with BTIG.
Ryan Zimmerman:
Good morning. Thanks for taking our questions. I want to ask -- I'll ask both questions upfront. The first one I want to ask is around ROSA versus TMINI. And when you announced that transaction or you announced that partnership, I think there was some fear that TMINI could replace ROSA, at least in terms of how the stock reacted. And so, Ivan, if you could kind of talk about kind of how you think about adoption of those two options over time, where TMINI fits in terms of either setting of care or utilization? And does that kind of reflect the proportion of knees and hips that are done in an ASC versus hospital? And should we think of it that way? And then my second question is just a follow-up to Larry's question on margins for Suky. Price was positive this quarter. But you did call higher manufacturing costs. And so, when do you turn the corner on higher manufacturing costs? Is that sometime in 2025 that we see that improve? And how durable is your pricing benefits? Thanks for taking the questions.
Ivan Tornos:
Hi, thank you, Ryan. Look, TMINI is not going to replace ROSA just like OrthoGrid is not going to replace ROSA. It's all about having breadth of portfolio. TMINI offers CT scanning, which some surgeons like and TMINI is the only handheld robotic platform in the world, which is something that, in an ASC environment, surgeons seem to like. What I will tell you is that we are deeply committed to ROSA, point in case, all these new platforms and indications we're going to be launching over the next four quarters to eight quarters, point in case, the commitments we made at the Investor Day of doubling our penetration from somewhere in the 20% of all U.S. knees done robotic with ROSA to 40% in the next three years. ROSA continues to be one of the fastest growing platforms here at Zimmer Biomet. We grew again in the U.S. or capital sales for ROSA 16% in Q2. Overall, it was double digit globally. ROSA today is already outside of the U.S., the leading robot platform, number one in Asia Pacific, fast growing in EMEA. And I think we're very pleased with where we are with ROSA, but we know we need to have optionality and we like our chances when it comes to that. In terms of the revenue contribution of robotics, is one of the most meaningful ones. And as we the double penetration, you should assume that our knee and hip number and shoulder later in the year is going to continue to grow.
Suky Upadhyay:
Hi, Ryan, Suky. Good morning. Thanks for the question. Let me start with price and then I'll go to your question on manufacturing costs. So price, as I noted in my earlier commentary, we were positive 80 basis points in the second quarter, and that marks overall a positive pricing first half for the company. I think it's probably the first since I've been here. The way that breaks down is, we saw really strong performance in EMEA, APAC was about flat to slightly up in the second quarter, and the U.S. -- the U.S. was down year-over-year on pricing. But overall, a very good quarter. That's a combination of a number of variables. One, a more favorable environment; two, we're getting greater discipline in analytics and governance around pricing and a better culture, I would say, around pricing; and the third is, we saw some onetime benefits, especially in EMEA, that helped drive that positive performance in price for the second quarter. Our outlook for the full year on price, originally, I started out the year saying that we thought we'd be about 100 basis points. I would say now we're going to be somewhere flat for the full year to potentially down 50 basis points. And the reason why that flip is in the second half is because some of those onetime benefits that we saw in EMEA in the second quarter, we don't expect to repeat at the same level or intensity in the second half. So that's a little bit about price. Definitely seeing much better improvement in performance this year. And we think a large part of that is going to run into 2025, because a large part of our business is contracted. So, again, we'll give more color on '25 when we get to that point, but really happy about the trend that we've got going here on pricing in 2024. Relative to manufacturing costs, yes, manufacturing costs are higher this year, again, because of the capitalization for 2023. I'm not going to give specific guidance into '25, but rather, I'll refer back to our LRP in our Investor Day, where we talked about operational stability in gross margin over the LRP. That, in fact, implies that we should start to see operational stability in manufacturing costs through that LRP. But again, as we continue to progress through '24 and into '25, we'll provide more color on that. All right. I feel good about the progress -
Ryan Zimmerman:
Thank you, both.
Suky Upadhyay:
Yes, I feel good about the progress the team's making on manufacturing costs. And I will say, we're finally starting to see some stabilization in overall inflation, both on raw materials, as well as third-party manufacturing costs. So, glad to see that inflection.
Ryan Zimmerman:
Thank you.
Zach Weiner:
Thanks, Ryan. Katie, could we have the next question?
Operator:
We'll go next to Robbie Marcus with JPMorgan.
Robbie Marcus:
Great. Good morning. Thanks for taking the questions. Two for me. First, the -- outside the U.S., hip and knee came in pretty strong today, even when factoring in the currency headwind versus consensus. So, maybe you could speak to the trends you're seeing there? Is it different Europe versus Asia Pac? And did you see the same headwinds that you saw in the U.S. with vacation days or supply constraints there?
Ivan Tornos:
Yes, I'll take that, Robbie. Good talking to you here. So the volumes outside the U.S. remain very strong, in particular in Europe, and within Europe, in the U.K., where we know there is a prominent backlog. So, market dynamics are very healthy, more in EMEA than APAC, but very healthy overall. One of the biggest drivers of growth outside of the U.S. is robotics. I mentioned that earlier in my answer to Ryan, I believe. We continue to see fast adoption of ROSA in key markets outside of the U.S. We are the number one platform in Asia Pacific. We continue to drive adoption in key countries like Japan, as well as Australia and New Zealand. We have accelerated Persona growth, moving from NexGen to Persona in these key geographies. So, it's a combination of market dynamics and great commercial execution. That's the answer there.
Ivan Tornos:
Great. Maybe on -
Zach Weiner:
Thanks, Robbie. Katie, can we have the next question? Go ahead, Robbie. Sorry.
Robbie Marcus:
Do I get a follow-up?
Ivan Tornos:
I'm sorry. Robbie, sorry. As I say, the U.S. dynamics that I mentioned are relative to the U.S. You mentioned surgeons being out of the territory. That is very, very focused in one month, in one quarter within the U.S. So, this is not a dynamic that we saw outside of the U.S. Wanted to answer your second question.
Robbie Marcus:
Great.
Zach Weiner:
Go ahead with your follow-up.
Robbie Marcus:
Maybe on S.E.T., you talked about all of the segments grew. Maybe could you just give us a little color into each of the segments there, how they grew and sort of the trends you saw? Thanks a lot.
Suky Upadhyay:
Yes.
Ivan Tornos:
Yes. Thanks, Robbie. I won't get into a lot of detail here. What I will tell you is that the growth drivers, those being CMFT, sports, and shoulder, are growing either upper-single digit or double digit. And the other three, foot and ankle, trauma, and restorative therapies, are growing at different levels, but all of them growing. So the challenge we've had with RT reimbursement-wise, that's behind. So, great to see all six businesses within S.E.T. performing.
Zach Weiner:
Thanks, Robbie. Katie, could we have the next question?
Robbie Marcus:
Appreciate it. Thanks a lot.
Operator:
Thank you. We'll go next to Jayson Bedford with Raymond James.
Jayson Bedford:
Good morning. Thanks for taking the questions. I guess, first, I appreciate you don't guide by segment, but maybe within your 5% to 6% organic revenue growth guide, has your internal thinking changed with respect to growth in the different segments?
Ivan Tornos:
Can you repeat the question?
Jayson Bedford:
Yes. So I'm just wondering, relative to the beginning of the year, your 5% to 6% topline growth hasn't changed. But I'm just wondering, has the -- your view on segment growth changed at all? Meaning, is S.E.T. now a bigger contributor than you thought at the beginning of the year, et cetera.
Ivan Tornos:
No, no. We continue to S.E.T. and Recon performing the way that we anticipated early in the year. So again, some timing in Q2 with U.S. Recon. But as we get into the second half, the expectation remains the same, is no one bigger than the other.
Jayson Bedford:
Okay. Fair enough. And just as a quick follow-up, Ivan, international was strong. You talked earlier about -- you stressed geographic diversification. I was a little unclear, are you entering new markets? Are you allocating more resources to certain geographies? Just if you could expand on the stressing of geographic diversification?
Ivan Tornos:
Yes, thank you. I would call it a more focused strategy. 15 countries today account for 93%, 95% of the overall market potential. In the past, we've been candidly all over the place. In the last two years, call it, we refocused the strategy to those key markets that matter the most. And I won't go through every one of those countries, but it is 15 countries. So OpEx and CapEx is being reallocated to those geographies. Our commercial infrastructure has been modified in those countries and the way that we focus in those countries is different. So that's what we're doing outside of the U.S.
Zach Weiner:
Thanks, Jayson. Katie, can we go to the next question, please?
Operator:
We'll go next to Josh Jennings with TD Cowen.
Josh Jennings:
Hi, good morning. Thanks for taking the question. A multi-part on the hip franchise and the recovery here. I may have missed some of this in your answers and prepared remarks, but just wanted to focus in on ROSA Hip. Just can you help us think through where robotic assistance penetration is for total hips? Do you think Zimmer's ROSA Hip platform is holding its own? Are you maintaining share in that channel? And then is this worth a good acquisition? Could you integrate that technology into the ROSA Hip application down the line?
Ivan Tornos:
All right.
Josh Jennings:
Thanks for taking the questions.
Ivan Tornos:
Sure. So I'll start with the question on whether ROSA Hip is performing. The penetration is double digit. It continues to meet the expectations that we had. We believe that we need to have a ROSA posterior application to gain market share outside the U.S., and that development is in motion. And we also believe that to a certain segment of customers here in the U.S. that want a less expensive, faster, lighter application, surgical AI by OrthoGrid is going to be a good modality. But so far, our expectations have been met with ROSA Hip and navigation in general.
Josh Jennings:
Thanks a lot.
Zach Weiner:
Thanks, Josh. And thanks, everyone, for the questions this morning. I'll turn it over to Ivan for some closing remarks.
Ivan Tornos:
Well, I'd like to close the way that I started with, gratitude. I'm very thankful to all the Zimmer Biomet team members for the progress. As I alluded to earlier in the call, this is the 10th quarter in a row where we're growing mid-single digit or above. We're pleased with the quarter, delivering close to 5-point - or actually 5.6% ex FX revenue, with double-digit EPS. We've proven that we can make commitments and deliver on those commitments. I like the fact that we have a diversified portfolio. We don't depend on one segment in one country. It's a well-diversified sustainable performance. And what we'll tell you is that we are more confident than ever that we will deliver in the guidance that we reaffirmed today. So, thanks to everyone for joining the call, and I look forward to the next update.
Operator:
Thank you again for participating in today's conference call. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet First Quarter 2024 Earnings Conference Call. [Operator Instructions]. As a reminder, this conference is being recorded today, May 2, 2024. Following today's presentation, there will be a question-and-answer session. [Operator Instructions].
I would now like to turn the conference over to Keri Mattox, Chief Communications and Administration Officer. Please go ahead.
Keri Mattox:
Thank you, operator, and good morning, everyone. Welcome to Zimmer Biomet's First Quarter 2024 Earnings Conference Call. Joining me today are Ivan Tornos, our President and CEO; and CFO and EVP Finance, Operations and Supply Chain, Suky Upadhyay.
Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by the forward-looking statements due to a variety of risks and uncertainties. Please note, we assume no obligation to update these forward-looking statements even if the actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties in addition to the inherent limitations of such forward-looking statements. Additionally, the discussions on this call will include certain non-GAAP financial measures, some of which are forward-looking non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures and an explanation of our basis for calculating these measures is included within our Q1 earnings release which can be found on our website, zimmerbiomet.com. With that, I'll turn the call over to Ivan. Ivan?
Ivan Tornos:
Thank you, Keri, and thank you, everyone, for joining the call here this morning. I'd like to start today the way that I typically do by taking a moment to recognize and to show my gratitude to the 18,000 Zimmer Biomet team members across the globe, who each and every day work relentlessly in driving our mission forward. Simply put them, I'm very proud of each and every one of you. Thank you for your dedication, for your commitment, resilience and for your strong performance to start off this year 2024.
It is truly this great workforce and the culture that we have here in place at Zimmer Biomet that gives me -- gives us confidence behind the financial commitments that we're making. Given the fact that we have a very robust Investor Day coming up in just a few weeks, I will keep my opening remarks short with the goal of moving quickly into today's Q&A session. I'll touch on 3 key areas briefly. First, I'm going to provide some general comments on the results in the quarter versus our own expectations. Secondly, I'll cover the drivers of the performance, and we'll touch on why we believe that these drivers are sustainable. And then lastly, I'll close with a brief summary on our progress against our 3 strategic priorities, which have been discussing since day 1, those being people and culture, operational excellence and diversification innovation. Starting with the quarterly results. Overall, we are very encouraged with our Q1 performance which was ahead of our own expectations, driven by healthy end markets, combined with the strong execution across the organization globally. We ended the quarter continuing the momentum that we saw in 2023, delivering 4.4% constant currency revenue growth, while overstepping a sizable day rate headwind and facing rather difficult comps versus a year ago. In fact, it is reassuring to see that on a day rate adjusted basis, our growth for the quarter was greater than 6% with several areas of the business and geographies contributing to such solid results. In addition to the sound revenue performance, we drove adjusted margin expansion and grew adjusted earnings even while our effective tax rate increased over 200 basis points. These results to start 2024 and give us great confidence that Zimmer Biomet will deliver 5% to 6% constant currency revenue growth in the year while driving sizable adjusted operating margin expansion. So pleased to reaffirm our guidance for the year. This, in turn, will enable mid- to high single-digit adjusted earnings growth while realizing our commitment of seeing free cash flow growing faster than earnings. Suky is going to provide more color around these areas later, but a strong performance in the quarter. And again, reaffirming guidance for the year. Net-net, it's encouraging to see us exiting Q1 of 2024 with a revenue growth run rate in the mid-single-digit range, which is consistent with where we exited the second half of 2023. With new products -- new product introduction ramping later in the year, we like what we see in terms of sustainability in our growth trajectory which we have said all along will accelerate in the second half of 2024. Key drivers behind our Q1 results came from both a macro and micro standpoint, starting with macro factors or end markets, as we've been saying all along, remain very healthy, driven by high levels of patient demand due to demographic shifts. The continued shift today we see here in the U.S. is also a tailwind and across the board in the industry, we've seen better surgical outcomes and technological advancements, which are driving more pace in demand. On top of that, you've got to improve pricing dynamics. And to that end, pleased to report that pricing in the quarter was about flat as opposed to the 200 to 300 basis points of price erosion that this space, this industry has seen historically. From a macro standpoint, the main enablers of our Q1 results were the adoption of ROSA technology globally, with a correlated pull-through of Persona Knee. We also saw some execution of growth drivers within S.E.T., particularly in shoulders, within sports medicine and in our CMFT, craniomaxillofacial thoracic business in conjunction with rapid adoption of Persona OsseoTi, that is our cementless platform, which is quickly gaining share in the markets where we have launched the product. As we enter the second half of 2024, these new product introductions as well as other new product entries will become more meaningful from a revenue growth standpoint with Persona OsseoTi entering then a full launch status, seeing higher realization of HAMMR or surgical Impactor, which we recently launched and also gaining traction with ROSA Shoulder, which we started doing cases recently here in the U.S. On top of that, we're going to be entering the market with our triple-taper hip stem, that's Z1, which is going to allow us to better compete in the direct anterior hip category. So really excited about the completed portfolio in hips and the upcoming launch, FDA approved now for Z1 hip stem. In addition to driving successful 2024 annual results, we are committed to the 3 strategic priorities that I outlined in my first earnings call as the CEO in November 2023. This, no doubt, will enable long-term success for the organization. I continue to repeat these 3 priorities over and over at every Zimmer Biomet meeting around the world. And I can tell you that they are resonating with the audience as the absolute must do's for the long-term success of the organization. Once again, these 3 imperatives are people and culture, number one; operational excellence, number 2; and innovation and diversification number 3. I would like now to quickly provide you with an update in terms of key progress across these 3 areas. Further detail will come during our May 29 Investor Day in New York City. First, in the area of people and culture, we continue to operate Zimmer Biomet with best-in-class engagement metrics and low employee attrition. We have been recognized across different areas when it comes to people and culture. And recently, we've been showcased in various publications, including Newsweek, Great Places to Work and Forbes. In the area of people and culture, it's worth noting also that our restructuring program, which we announced a quarter ago, has now been implemented almost entirely with no major disruptions to report. We have realized substantial benefits post this initiative, including realizing cost savings earlier than initially expected as well as achieving increased operational agility and enhance accountability. In the second area of operational excellence, we've made robust progress in implementing our enhanced inventory management programs around the world. Working intensely with third-party firms, we develop a plan we're executing against the plan. We remain committed to a meaningful improvement in DOH in the year 2024 and in years to come. Again, more color in that regard during our Investor Day. In operational excellence, we have also established core initiatives around best-in-class product launches to ensure that these new product introductions gained traction sooner than expected and we launched these products in a better way than we have launched in the past. This is beyond critical for Zimmer Biomet as we continue to deliver a rapid cadence of product launches with plans to release more than 40 new products in the next 24 to 36 months. One final comment in operational excellence in the area of pricing, we've made structural changes to further enhance the pricing strategy that we put in place over the last several quarters. Moving on to the third and final strategic priority. In the area of innovation and diversification, we're making solid progress. We continue to see strong traction in key brands such as Persona OsseoTi. I mentioned already gaining share in the markets where we have launched. We've seen progress with ROSA. We continue to gain momentum with Signature ONE planning guides in the shoulder space, and we love what we're seeing with our Embody soft tissue franchise. CMFT continues to deliver new product introductions, gaining share in the markets where we partake. And I'm very excited about the new product introductions that we have seen and we'll continue to see in our ASC portfolio in the U.S. We've also made tremendous strides in new products with a more focused pipeline that today as of Q1 2024, has twice the dollar value that we had at the end of 2018. So the dollar value of the pipeline in innovation is twice what it was 4 or 5 years ago. Worth reminding everyone that north of 80% of these products in the pipeline, residing markets growing above 4%, and many of them are accretive from a gross margin standpoint. So we continue our commitment of innovating from a customer-centric standpoint, but also innovating to see incremental profitability and an increased WAMGR profile. In addition to driving results in core markets, we're also focused on diversifying our portfolio into more attractive, faster-growth end markets with the goal of increasing our WAMGR, Weighted Average Market Growth Rate. We have made significant progress over the past several years, balance it through what it is today. And this fact in addition to the confidence around future free cash flow generation, give us the optionality and the firepower to execute on the right deals at the right time, the most importantly, meet our internal hurdles from both a financial and a strategic perspective. So again, lots going on inorganically potentially as well as organically with the size of the pipeline. While we have flexibility in the size of the deals to come, we continue to favor the smaller tuck-ins to midsize deals. That's up to $2 billion in acquisition price that become EPS neutral within 2 years and that from a ROIC standpoint, return on invested capital, will deliver upper single digit to low double digit within 5 years. As I mentioned earlier, we're very encouraged with our Q1 performance, a quarter in where we grew 4.4% in constant currency, north of 6% in day rate while overcoming a number of head winds and tough comps. It is this quarter results from the first quarter 2024 that give us a strong confidence that in the year 2024, we will realize our guidance of delivering 5% to 6% in revenue, growing 100 to 200 basis points above market while delivering earnings growing faster than revenue and delivering free cash flow above the earnings growth. This is the commitment that we're making for 2024, and it's a commitment that we're going to reiterate in our Investor Day for years to come. Before closing the call, I'd like to announce that Keri Mattox has made a decision to depart from Zimmer Biomet at the end of May. Keri has been a trusted partner and a very close collaborator and friend on this journey and has enabled great things for Zimmer Biomet in her 4-plus years here with ZB. She's going to be missed, and we wish her the best in her future endeavors. A search for a Head of IR position is in progress with a leading executive search firm, and we hope to announce Keri's replacement here very soon. Zach is going to continue to lead IR interactions for Zimmer Biomet. So a plan for continuity is in place. In conclusion, we're very proud of how far we have come as an organization and are even more excited about where we can go. Strong confidence on the year 2024. We continue to make commitments and deliver on those commitments as evidenced by these results and as evidenced by the new product introductions commitment that we made and we're realizing. I love the fact that we are impacting the lives of millions of patients around the globe, and I'm inspired by the fact that my team mates are living the Zimmer Biomet mission of alleviating pain and improving the quality of life for people around the world. And with that, I'll turn the call over to Suky. Suky?
Suketu Upadhyay:
Thanks, and good morning, everyone. As Ivan mentioned, we had another good quarter driven by healthy end markets and solid execution across the organization. Overall, we remain on track to deliver on our 2024 financial guidance with mid-single-digit constant currency revenue growth, adjusted operating margin expansion and over $1 billion of free cash flow. Assuming current market conditions, this is a financial profile that we believe is durable going forward.
Moving to Q1 results. Unless otherwise noted, my statements will be about the first quarter of 2024 and how it compares to the same period in 2023, and my commentary will be on a constant currency and adjusted operating basis. Net sales were $1.889 billion, an increase of 3.2% on a reported basis and an increase of 4.4%, excluding the impact of foreign currency. Additionally, we had a selling day headwind of about 200 basis points that impacted all regions and product categories at about the same level. Excluding the selling day impact, consolidated constant currency sales would have grown above 6%. U.S. growth was 3.7% and international grew 5.4%. Growth in the U.S. was driven by solid performance in RECON in our priority areas within S.E.T. as well as our other category. Outside of the U.S., EMEA saw stronger-than-expected growth on a regional basis. And from a portfolio perspective, OUS growth was primarily driven by our knee category. Global Knees grew 4.3% in the quarter with the U.S. growing 2.2% and international growing 7.3%. Growth in our knee business continues to be driven by our Persona product portfolio and ROSA Robotics platform. We remain excited about the growth coming from new and recent product launches across the knee segment. Global Hips grew 1.5% in the quarter with the U.S. growing 1% and international growing 2%. We remain focused on accelerating performance in the Hip segment with key product launches that Ivan mentioned earlier. Next, the S.E.T. category grew 5.3%, led by our key focus areas of CMFT, upper extremities and sports growing on average about low double digits. This strong growth was partially offset by the other subsegments within the category. Despite the choppiness within S.E.T., we remain confident this business will drive mid-single-digit or above growth for the full year. Finally, our other category grew 12.2%, driven by continued strong ROSA sales. We expect growth in the other category will moderate lower as we move through the rest of the year. In Q1, we reported GAAP diluted earnings per share of $0.84 compared to GAAP diluted earnings per share of $1.11 in the prior year. Higher revenue and a lower share count in Q1 2024 was offset by higher selling costs and expenses associated with our restructuring program. On an adjusted basis, we reported diluted earnings per share of $1.94 compared to $1.89 in the prior year. The step-up is primarily driven by revenue growth, accelerated savings pull-through from the restructuring program and a lower share count, partially offset by higher interest expenses and taxes related to Pillar 2. Foreign currency was a headwind of about $0.04 in the quarter when compared to the prior year. Our adjusted gross margin was 72.9%, driven by higher manufacturing costs, which were offset by better pricing and lower royalties. Overall, gross margin was in line with expectations and with the prior year. Adjusted operating margin was 28.6%, slightly ahead of the prior year. The increase in operating margin was driven by higher sales and lower SG&A related to the restructuring program I referenced earlier. Net interest and other adjusted non-operating expenses were $49 million in the quarter, slightly higher than the prior year. And our adjusted tax rate was 18.5%, and we continue to project our full year rate at 18%. Turning to cash and liquidity. We generated operating cash flows of $228 million, free cash flow of $91 million, and we ended the quarter with $393 million of cash and cash equivalents. Regarding our outlook for the rest of the year, we are reiterating our full year guidance, including constant currency growth of 5% to 6% or 4.5% to 5.5% reported revenue growth with a 50 basis point currency headwind. Additionally, we continue to expect earnings to be between $8 to $8.15, and that we will generate between $1.50 billion to $1.1 billion of free cash flow. From a cadence perspective, we still expect constant currency revenue growth for the first half of the year to be at the lower end of mid-single-digit growth in the second half of the year to be at the upper end of mid-single-digit growth. As a reminder, Q2 and Q3 will each have about 150 basis point tailwind due to selling days and the selling day impact for Q4 and for the full year is expected to be immaterial or less than 50 basis points. Regarding the P&L, we expect adjusted gross margin to be broadly in line with 2023 and slightly better than our original thinking due to less FX headwinds than originally assumed. Given the strength in dollar, FX hedge gains are not as big a stepdown in 2024 as originally expected. Looking at gross margin, we expect Q1 to be the high watermark, followed by a modest sequential step down throughout the year. Overall, first half gross margins will be about 100 basis points higher than the second half as we continue to feather in capitalized inflationary costs from the second half of 2023. Turning to adjusted operating margin. We are pleased with the start to the year as our restructuring efforts are delivering slightly ahead of schedule. Overall, second half operating margins will be higher than the first half. And we expect for the full year that at the midpoint of our guidance, we will increase operating margins by about 80 basis points. In summary, Q1 was a good start to the year. We delivered results ahead of expectations and continue to feel confident in our 2024 outlook as evidenced by the reiteration of guidance. With that, I'll turn the call back over to Keri.
Keri Mattox:
Thanks, Suky. And thanks, Ivan, for the kind words. It's been such a privilege to be part of the Zimmer Biomet team these 4.5 years, and I wish the team much continued success moving forward.
Now before we start the Q&A session, just a quick reminder to please limit yourself to a single question and one brief follow-up so that we can get through as many questions as possible during the call. With that, operator, may we have the first question, please?
Operator:
We'll go first to Travis Steed with Bank of America.
Travis Steed:
Keri, great working with you and good luck in your next endeavors. I guess, kind of high level, you guys have this kind of algorithm, 5% to 6% revenue growth potential for some margin expansion and possibly kind of low double-digit EPS growth. And just trying to think about how we should think about that algorithm over the long term. Is it more of a base case or kind of best case? There's just a lot of skepticism from the investor community on that algorithm. And trying to think about what's the Zimmer growth rate kind of on a sustainable basis in a normalized market? And then just the second question I'll go ahead and throw out too. Just any color on Q2 sequentially. It's usually down, Hips and Knees is usually down a little bit sequentially, but with some of the selling day stuff, I just wanted to make sure there wasn't any titration on Q2.
Ivan Tornos:
Travis, Ivan here. Thanks for the question. I'll touch on both components of your question, and I'll make sure that Suky speaks up here as well. So starting with the algorithm on revenue, EPS and free cash flow. We're going to give more color in the Investor Day, but I will tell you today, as per the prepared remarks, this is a long-term commitment. So it's not a 2024 only deliver revenue above market, EPS above revenue and free cash flow above EPS growth. And unpacking the drivers here on revenue, it's all about new product introductions. We're going to gain share by delivering innovation that matters. 100 to 200 basis points, largely is going to come from new product introductions. And as we said all along, we got a pipeline that we didn't have before, 40 new product introductions over the next 24 to 36 months, more in the making. So that's the #1 driver on revenue in addition to obviously pricing dynamics and commercial execution.
On EPS growth, we're doing things differently when it comes to margin, I already mentioned pricing, but other components, how we think about inventory in excess and obsolescence, how we think about allocation of OpEx, where we get the greatest return, et cetera, et cetera. And the free cash flow, the main driver is the fact that we have run this company in quite an inefficient way when it comes to inventory management. North of 400 days on hand when it comes to inventory, not really engaging on prioritization of geographies. Portfolio management is not what it needs to be. So those are the key drivers on the sustainability. I'll touch on #2, and then I'll give it to Suky. In terms of Q1 to Q2 to Q3 to Q4, what happens sequentially. Look, we're not going to get into the gymnastics on what happens quarter-over-quarter, all kinds of timing 1 quarter to the other. We call -- we're having similar conversations in Q4. Here is what I'd leave you with. Q1 was very strong. A 4.4% growth in constant currency, north of 6% in day rate. As we see here, looking at the year, we were confident at the very beginning of the year in the guidance of 5% to 6%, a quarter behind, we're extremely confident on the guidance. The growth drivers that get us there are working in the right direction. So very, very confident, very proud of Q1. And again, we'll talk more about the dynamics at Investor Day. Suky?(43:40)
Suketu Upadhyay:
Yes. I think Ivan summarized it really well, so I'll just try to build some incremental points here. I think at that mid-single-digit growth top line profile that Ivan mentioned, we do have a durable path to operating margin expansion as well as improvements in overall free cash flow conversion.
On the earnings outlook, this year, if you look at our guide, it's 6% to 8%, which, again, we reiterate and feel confident in. If you -- on an underlying basis, if you back out the step-up in tax rate that we saw at Pillar 2 as well as headwinds that I think everyone is facing on interest as well as FX, the underlying growth on the bottom line is much better than 6% to 8%, maybe 300 to 400 basis points better on an underlying basis, which puts us kind of in that high single digits, low double digits. And if you look at what we did in '23, I think we were also there. As we look forward, using your words Travis, base case, et cetera, we think there's a pathway to low double-digit earnings growth. I wouldn't say it's our base case or our commitment. And again, we're going to provide more color on our Analyst Day. But as we think about margin expansion with revenue growth, we just want to make sure we've got the right investment profile to the company to make sure that, that growth is durable. So is that our base case, I wouldn't necessarily go there. I'd say we have a pathway there. But we're going to provide a lot more color in just a few more weeks.
Keri Mattox:
Katie, can we have the next question in the queue?
Operator:
We'll go next to Steve Lichtman with Oppenheimer & Company.
Steven Lichtman:
Congratulations on the quarter, guys. And Keri, it's been great working with you. I guess I'll first start on pricing commentary. I thought that was notable. Ivan, can you talk about where the positive surprise came from on that front? Are the benefits of your efforts coming sooner? Just some general comments on the pricing environment would be great.
Ivan Tornos:
Yes. We're very -- Steve, thank you. We're very pleased, obviously, with pricing performance. Recall that in 2023, the second semester of '23, so the last half of '23, we're already flattish when it comes to price. So this is a business that in previous years was having 300 to 500 basis points of price erosion in the U.S., pretty significant OUS. That's not the change that we have going on. We put a structure in place. We put governance, new product introductions are helping from a category contracting.
I wouldn't say there's any real surprises. Europe may be doing slightly better than anticipated. You've got all kinds of [ tender ] dynamics that come in and out. But net-net, we are at a point where it is pretty predictable. We like the strategy in place. We like the governance. We're not going to commit here to doing dramatically better, but no real surprises, only Q1 and a great outlook for the rest of the year. Suky, do you have any other comments?
Suketu Upadhyay:
I think overall we're in more favorable environment than we've been, let's call it, 3, 4 years ago. When you combine that with some of the structural changes we're making inside the company, that's -- I think those 2 things are really leading to better price performance. I'll tell you, I'm really impressed and optimistic about the cultural change, quite frankly, within Zimmer Biomet as I talked to distributors or field level reps and their desire to want to make sure that we're getting the value for the products that we bring to market. That's encouraging. And I think that makes it durable.
In the quarter, we were roughly flat. I do expect us to be -- when I set out the year, I thought we'd be 100 to 150 basis points of erosion. I think we're now under 100 basis points of erosion especially given what we saw in the first quarter. I don't expect that flat profile to continue through the rest of the year because we've got a number of things that happened at the back end of last year, especially in Europe where we took some pretty large price increases in devalue sort of currencies and markets that will sunset later on this year. Also, we've got some new contracts that are coming up, which will create a little bit of pressure. So I don't expect that flat profile to continue through the rest of the year. But nonetheless, we're in a much better spot than we were a few years ago. And again, expect overall pricing to be somewhere under 100 basis points for the full year '24.
Steven Lichtman:
Great and then quickly follow-up -- just wanted to follow up real quickly on the ROSA shoulder. Just on the initial launch and your outlook for ramp this year?
Ivan Tornos:
Yes. Thank you. Obviously, very excited in terms of this product launch. We did the first cases at the Mayo Clinic a couple of weeks ago. Feedback was very solid. It is a product that has a high degree of accuracy in the cuts in the visibility of anatomy. It is efficient from an instrumentation standpoint. It's fully interconnected with the rest of the CVH ecosystem. Case over case, the feedback was that you do achieve time efficiencies. So the learning curve is rather short.
So very solid clinical feedback. In terms of the impact, we said all along that we're going to take it slowly in the first, call it, 90 to 120 days. And you will see the real impact as we get closer to the end of the year. But a very meaningful product launch for the company. I'm very excited about it. Thanks, Steve.
Operator:
Larry Biegelsen with Wells Fargo.
Vikramjeet Chopra:
This is Vik Chopra in for Larry Biegelsen. Keri, thanks for all your help and good luck. So 2 for me. I just wanted to get a sense as to kind of what we can expect at your upcoming Investor Day at the end of the month. With regard to financial goals, will you have specific LRP goals for revenue? Or will it be relative to the market, for example, growth of 100 to 200 basis points above market. And then I had a follow-up.
Ivan Tornos:
Yes. No, we'll definitely cover the -- how we plan to achieve these 3 commitments we're making from a financial perspective in terms of what are the drivers of revenue, EPS and free cash flow. So we'll definitely provide those details. We'll cover the new product introductions, we've seen that. We'll talk about the capital allocation on the strategy moving forward. So it's going to be very robust. So that's the Analyst Day.
Vikramjeet Chopra:
The second question I had was you beat consensus EPS by about $0.07, but you didn't really raise the guidance on EPS. Can you just provide some color on that?
Suketu Upadhyay:
Yes. I think Ivan said it really well in his opening remarks. We had a good start to the year, and it was great to see the better-than-expected performance in revenue. We saw a very good flow through all the way to the bottom. So I love the discipline that we've got throughout the company. I would say that this just reinforces and gives us more conviction in the guidance range that we provided earlier this year.
Operator:
We'll go next to Rick Wise with Stifel.
Frederick Wise:
And we'll miss you, Keri. I'll ask my question and my follow-up at the same time. Ivan, obviously, on all these new introductions; OsseoTi HAMMR, the robotic shoulder, but -- and all of them sound like they'll be meaningful and I assume will help pricing, will help gain share, will help leverage your fixed cost, your operating costs.
But I was hoping you'll focus in particular on the implications of the Z1 launch. You highlighted the product several times. Is this the lynchpin product that you've been missing to make your hip portfolio more credible and to bring your business up to sort of more industry norms? And my second -- my follow-up is sort of related to all that, relates to margins. Suky, I mean, I heard what you said about gross and operating margins. But again, when I think about all these introductions, I assume better pricing and margins and share and leveraging. Why should I believe you on everything you just said about the margin outlook?
Ivan Tornos:
Thank you, Rick. I'll cover the Hip question, and then we'll proceed with the interrogation of Suky here when it comes to the margin. One product is not -- one product is not what's going to win the battle here, right? It is a category of products. We've been very transparent. We've not done great when it comes to hips over the last 3 or 5 years and essentially driven by 3 product categories.
The first one is a direct anterior stem what is not in the market as a triple taper stem and it was a deficiency that we had. Z1 solves that and it does in a differentiated way. So now with this 510(k) approval, we compete with the 2 other large orthopedic companies in direct anterior. The second category was a surgical impactor. It drives efficiency, it drives accuracy in how you treat the cases. It integrates with the rest of the procedure. You need certain levels of power as you do in that hip surgery. So there is a surgical impactor and we have that with HAMMR, fully launched, we're going to run that up. And the first thing that we needed was to have navigation. We got true modalities navigation. Obviously, we've got ROSA Hip. We are the only company with a 510(k) FDA approved Mixed Reality Technology in our partnership with HipInsight. So again, it's not just Z1, it's the full portfolio. Direct anterior stems, surgical impactors and some sort of navigation. So I do believe and we do believe with a high degree of confidence that we're going to regain our old position in hips. We still remain the #1 hip company in the world, and I think that this portfolio accelerates our growth journey moving forward.
Suketu Upadhyay:
And Rick, it's Suky. Always good to hear from you. On the margin front, I know the past isn't always indicative of the future, but I'll just -- it is a good validation and proof point, I think, in our situation. Both '22 and '23, we're able to expand operating margins quite significantly, I would say, even in the backdrop of a pretty hostile inflationary environment. And so again, kudos to the entire [ CE ] team.
In '24, we expect to do it again. And here's what I would say. We're doing it across the entirety of the P&L. First, through revenue growth and leverage our fixed costs. Secondly, we're making improvements in cost at a rate that we've not done before through inventory reduction, site optimization, reductions in E&O. We're even getting more efficient inside of R&D and looking at, hey, do we really need all this sustaining and how can we rationalize some of our portfolio, migrate our customers to better products, get rid of some of these products, which then reduces the amount of sustaining engineering, which we can then mix shift into NPI. We're getting it through SG&A. We're getting it through better allocation of capital and reducing our cost of debt. The beauty of that is when you have multiple shots on goal to improve operating margins, even if things go unexpectedly from a macro perspective or a micro perspective, we have other levers to continue to help us pull margins as we move forward. And so the thing I'll leave you with is it's not just in one area of the company, it's throughout the entirety of the P&L, and we feel confident about where we're going. And quite frankly, and I love what Ivan's bringing. He's bringing his owner-operator mindset to the company. He's got the company thinking not just about top line, but all the way through cash, cash being king, and I think that's really driving a culture change within our company as well. So I'm optimistic on where we're going, Rick.
Operator:
We'll go next to Pito Chickering with Deutsche Bank.
Imron Zafar:
This is actually Imron Zafar in for Pito. First question is on ROSA, obviously, a strong first quarter there. Can you talk about placement trends in the quarter by site of care, hospital versus ASC? And then also competitive dynamics for [ ROSA ] Joint orthopedic robots?
Ivan Tornos:
Absolutely. Thanks for the question. So let's start with the global picture, if you will, very excited in terms of where we are overall with ROSA. So globally, ROSA is becoming the preferred robotic option in many markets outside of the U.S. Here in the U.S., we're approaching around 20% penetration of ROSA in cases.
As you saw in the quarter, we had a large amount of ROSA sales, which is encouraging because that means in the other category, that's encouraging because that's a future stream of net pull-through. About 1/3 of all the installs that we do in the U.S. go to an ASC environment, which, again, is not a surprise given the fact that ROSA does drive easier preplanning. You don't need to do a CT scan. It is very surgeon center, so it's very controllable. And we continue to see that there is a high degree of preference for ROSA in those higher volume accounts. So net-net, everything in the right direction in terms of penetration, where we are gaining traction in key markets around the world and a lot of the dynamic that we're seeing here in the U.S. ambulatory surgical center environment.
Imron Zafar:
Just as a quick follow-up. Can you remind us what the site of care mix is for shorter Recon hospital versus ASC?
Ivan Tornos:
So we're starting to see a dynamic in where cases are moving to the ASC for shoulders, getting the CMS change. I would say today, probably around 60% to 65% of the cases of shoulder are now done in ASC, but that's moving pretty rapidly, given the change of reimbursement. And we've got a strong position both in the inpatient, outpatient as well as the ASC. But I would say net-net, is around 60%, 65% to 35% in terms of that mix.
Operator:
We'll go next to Caitlin Cronin with Canaccord Genuity.
Caitlin Cronin:
Just touching a little bit further on ROSA and the strength in the other line, Suky, did you say that you expect lower growth in this segment through the year?
Suketu Upadhyay:
It was a little bit choppy there, Caitlin, Sorry, did you ask if -- you asked something about other? Could you repeat the question?
Caitlin Cronin:
Yes, apologies. Did you say that you expect lower growth in the segment throughout the year?
Suketu Upadhyay:
Yes. Yes. So we had a pretty strong quarter in our other category, primarily driven by ROSA Capital. So we saw good installs. And we saw a higher mix of sales versus placements which drove a higher level of dollar revenue in that quarter. The good news is we saw a lot of new placements and new ASCs, which is exactly where we want to see ROSA's position and the capital sales were very good.
We also love placements because that comes with a longer-term commitment. Our expectation is that we'll step down from what you saw in the first quarter as we move throughout the year, and that's been assumed in our guidance reiteration.
Caitlin Cronin:
Okay. And then any updates on Persona?
Keri Mattox:
Go ahead with a follow-up. Line is kind of choppy. Go ahead.
Caitlin Cronin:
Okay. Apologies. And any updates on the Persona IQ rollout?
Ivan Tornos:
Yes. Thank you, Caitlin. It's moving in the right direction. I will say, as of late, things are accelerating, both from an innovation and a commercial execution standpoint. So on innovation, we did receive recently the 510(k) approval for -- didn't make it to the press release for the study. So as the shorter stem version of Persona IQ, which has been a gating factor for some surgeons that don't use the longer stem. So that's an innovation and they are right there.
The other piece that is gaining traction is the launch of what we call recovery curves. This is a platform that only Persona IQ has. Interconnects the data of the TAM with a dashboard that in a very objective way, can quantify how patients are doing in comparison to other patients with similar dynamics. So those are 2 innovation updates that are more in the right direction. In terms of the execution and commercial journey, we got what we need. We got the right designs. We've been talking about value proposition. It's been resonating. We are in some of the largest teaching institutions, and we continue to be committed to the journey. So very excited about Persona IQ. Thank you for the question.
Operator:
We'll go next to Mike Matson with Needham & Company.
Michael Matson:
Yes. So I just want to ask one about kind of what the guidance implies for second quarter revenue. you're saying you expect to be at the low end of the mid-single digits to sort of like 4% in the first half. Based on what you did in the first quarter, that implies kind of like 3.5% constant currency growth, but you have the 1.5% selling day benefit. So that applies like 2% kind of underlying growth. Is that -- is my math right there? And I guess why do you only expect 2% growth in the second quarter?
Suketu Upadhyay:
Yes. Mike, directionally, the way you think about it, right, I wouldn't quite go as low as that. But look, quarter-to-quarter, there's going to be choppiness. There's going to be noise based on timing, contracts, et cetera. We had a great start to the year. We continue to believe and reinforce our guidance and still believe that the first half is going to land as we expected to when we initially gave guidance. So nothing in particular about the quarter of note, but just the overall cadence, that's how we expect first half versus second half to play out this year.
Michael Matson:
Okay. And then just a follow-up on OsseoTi. So you mentioned it's gaining share. Does that mean that it's actually converting competitive surgeons? Or does that just mean it's cannibalizing the cemented Persona?
Ivan Tornos:
No. We definitely are upgraded, if you will, some or for cementless -- legacy cementless platform over to Persona OsseoTi but at the same time, a sizable amount of the business coming from converting accounts. So you've seen that the U.S. knee number in the quarter was strong and a large component of that was the fact with pretty heavy comps, by the way, comes from the introduction of Persona OsseoTi and the expectation is that as we continue to move into the acceleration of the product launch, we're going to continue to gain share. So it's both existing accounts and new accounts.
Operator:
We'll go next to Vijay Kumar with Evercore ISI.
Unknown Analyst:
This is Sofia on for Vijay. One quick one on gross margins and operating margins. Were there any one-offs in the first quarter on gross margins. You guys raised the guide for margin but EPS was maintained. So is operating margin slightly down? And how do we think about margins for the rest of the year?
Suketu Upadhyay:
Yes. No real -- in any given quarter, there's going to be puts and calls, both in gross margin and operating margin, but nothing material or out of the ordinary. We did a little bit better on gross margin than we expected to. We saw that flow through in the operating margins. So we feel really good about the start of the year.
As we progress through the year, we do expect operating margins to step up in line with normal seasonality as revenue continues to step up and other savings programs pull through. So again, very confident in where we're headed from an earnings perspective in our guide. And if you recall, I think we said on the last quarterly call that at the midpoint, that implies about an 80 basis point lift in operating margin, and we're still confident in that.
Unknown Analyst:
Okay. follow-up question -- just one quick one on M&A. I know you guys have made some comments about tuck-ins and kind of what that profile will look like. But anything in the pipeline that are particularly interesting right now that will fit now in the portfolio?
Ivan Tornos:
Yes. We always have a robust pipeline. And we'll talk about the pipeline and the optionality of M&A in more depth once we meet in later in the month. But the same 3 key areas apply. We're looking for assets that are mission-centric from a strategic standpoint, fit in the higher-growth segments of Recon, certainly the high growth segments of S.E.T. as a category and then in the ASC space, which is a mixture of both 1 and 2. So we later focus on those 3 key areas while also keeping an eye on broader diversification.
Financially, nothing has changed. We have flexibility to do larger deals, but we like deals where the acquisition price is under $2 billion. We definitely want to be neutral from an EPS standpoint within 2 years and then high single-digit ROIC to double-digit ROIC in the 5-year time horizon. So very clear on strategic and financial filters and the optionality is there and the pipeline is there. So more to come once we meet in New York.
Operator:
We'll go next to Robbie Marcus with JPMorgan.
Robert Marcus:
Congrats on a good quarter. Maybe just one for me. You kind of talked about second quarter and the expectation on the top line, and you just answered kind of margin cadence through the year. But I want to put a finer point on it and try and avoid some of the cadence issues that we had last year. So you talked about operating margin expanding.
I wanted to make sure, I think the prior commentary was second quarter would be the highest operating margin and fourth quarter would be the highest for the year with a sequential down in third quarter with normal seasonality. So maybe to kind of say it all a different way. Are you comfortable with where the Street is on EPS or EPS for a second, third, fourth quarter, are there any cadence changes you think we should be looking at moving from 1 quarter to another?
Suketu Upadhyay:
Yes. So Robbie, just a little bit of a correction. I'm not sure if I caught everything you said or understood, I should say everything you said. Fourth quarter will be our high watermark relative to operating margin in line with that being our high watermark from a revenue perspective. And so our margin does, in many ways, correlate heavily to our revenue outlook.
Relative to the cadence, I'm not going to -- in consensus I'm not going to sort of benchmark relative to that. I think we've actually given pretty good color already around the first half, second half revenue cadence. I've talked about gross margins crossed a 100 in the first half, second in the back half and then operating margins improving in the back half of the year due to restructuring overall. So I think there's actually pretty good color out there in line with how we've traditionally been transparent. So hopefully, that gives you enough to go from.
Operator:
We'll go next to Chris Pasquale with Nephron.
Christopher Pasquale:
Ivan, you talked about 4 points of your revenue growth this year coming from market gains and then 100 to 200 basis points with outperformance. It gets you to your 5% to 6% goal. When we look at the first quarter, Recon growth was actually a little bit better than that, and that's really hard comp, [ parts ] comp of the year. So that 4% feels pretty conservative at this point.
Your own performance across hips and knees was a little below market. So while I appreciate you're excited about the pipeline and what it can mean for share gains in the out years, are you still thinking about the recipe to get you to your 2024 target the same way?
Ivan Tornos:
Yes. Thank you, Chris. First of all, I wouldn't categorize our performance being below market. And we're going to have a healthy debate on whether it's above or below. But what I will tell you is that when we stay here right now, it is not below market. Certainly not from a training standpoint over a period of time and now that everyone is reported in Q1, we're not below market. So I'll start with that.
In terms of how we get to the 5% to 6%, I think the formula continues to be product introductions, which will ramp up later in the year and even more product introductions as we get into 2025. We've never had 5.5, almost 6 years here with the company, I've never seen a poor portfolio. I mentioned earlier that we don't have any gaps in hips with the introductions that we have done in Knees, there's 0 gaps. I'm excited about the upcoming product launches in Europe. Let's not forget, we don't have Persona revision in EMEA. That's an almost $2 billion product here in the U.S., $2 billion over the last 4 -- 3, 4 years in gross sales. And let's not forget, we also bring in Oxford Partial Cementless from Europe here to the U.S. So strength in the knee portfolio, strengths in the hip portfolio. You've seen that S.E.T. we made a commitment that S.E.T as a category will grow mid-single digit or above. It's the third consecutive quarter where we're seeing that. And that's going to stay around. So I would say, strength in innovation, the strength in commercial execution and the 5% to 6% to us is an admissible commitment.
Christopher Pasquale:
Okay. And then following up on OsseoTi. Can you remind us where your cementless mix stands today in the U.S.? And over what time frame you think you could close the gap between your current penetration and where Stryker is at the moment?
Ivan Tornos:
Absolutely. So closing the Q1 quarter approaching 20%. So it's fairly similar to robotics. So cementless is approaching 20%. We'll break down some of these commitments, we keep repeating the same answer at the Investor Day. But our expectation, our ambition is to be where our competitors are, 60% 6-0. We'll provide time lines in that regard, but the north star is to have robotic penetration in the 60% range and cementless penetration in the 60%. So the fact that today we're at 20%, that tells you that there is pretty significant upside, and we're excited about the journey.
Keri Mattox:
Chris, thanks for the question. Katie, I think we have time for maybe one more question in the queue.
Operator:
I'll go next to Shagun Singh with RBC.
Shagun Singh Chadha:
So it seems like orthopedic robotics uptake stepped up for the market in Q1 or at least it was better than expected. Has anything changed from a capital appetite standpoint -- any reason you are seeing more upfront sales versus operating leases? And then just a follow-up on M&A. Ivan, you had indicated that you want to be -- you want to go bigger and bolder and we haven't seen a whole lot of that yet. I appreciate all the commentary on deal capacity of up to $2 billion and favoring tuck-ins. But very specifically, how do you plan to raise your weighted average market growth from 4% today mostly with tuck-ins?
Ivan Tornos:
So starting with robots and capital dynamics. Look, I will tell you one thing that is pretty prevalent is that here in the U.S., we've seen the cases move today, I see not a week goes by that is not a new ASC opening. And those ASCs do want to acquire robotics and you either install or you purchase it. And we saw a dynamic in Q1 where we saw more purchases.
We do believe this is driven by ASC dynamics. Capital continues to be strong across key markets. So definitely not a gating factor. And again, as I mentioned early, excited about the continuity here. In terms of your second question on M&A, look, we want to be bigger and bolder, at the same time, we don't want to be reckless. And I will say that all along. So we're going to stick to the strategic and financial thresholds. We got the pipeline, we got the money. And when it is time to act, we'll act on it. And we're not going to take the past as an indicator of how we're going to do things in the present and future. The breakdown on the WAMGR, we'll cover that as well once we get into the Investor Day. And it is a combination of organic and inorganic means. So we'll talk about the pipeline. I already mentioned -- we already mentioned that 80%, if not 90% of the new products in the pipeline are in markets that are growing above 4%, in some cases above 5%. So that's definitely a driver and then the combination of tuck-in deals and maybe some bolder moves will get us to the WAMGR that we deserve. So more to come in that regard. Thanks for the question. I think we come in to the end of the call. So I'm just going to briefly close with closing comments. I will start by saying that it's great to be here at home in Warsaw, Indiana today to celebrate our Founder's Day. So May 2, 1927, we started the company with a very clear purpose to alleviate pain and improve the quality of life for people around the world. So 97 years later, I just can say that we're just getting started. So excited to see where we are as a company. It's an exciting time to be at Zimmer Biomet. The portfolio is where it needs to be. We have strong commercial execution. We are very, very confident on our guidance for the year 2024. We are excited about what is to come in '25 and '26 once we are able to discuss the long-range plan. So that is seen by confidence and excitement. And before closing, I want to thank Keri for 4.5 great years with us. You've been a trusted partner, a great friend. You're going to be missed, although I'm going to continue to call you and seek your advice in many, many years to come. So thank you, Keri, and thanks, everybody.
Keri Mattox:
Thanks, everyone, for joining. We'll be talking to all of you today. If you have questions, of course, please don't hesitate to reach out to the IR team. Thank you again for joining the call this morning.
Operator:
That will conclude today's call. We appreciate your participation.
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet's Fourth Quarter 2023 Earnings Conference Call. [Operator Instructions]. As a reminder, this conference is being recorded today February 8, 2024. Following today's presentation, there will be a question-and-answer session. At this time, all participants are in a listen-only mode. [Operator Instructions]. I would now like to turn the conference over to Keri Mattox, Chief Communications and Administration Officer. Please go ahead.
Keri Mattox:
Thank you, operator, and good morning, everyone. Welcome to Zimmer Biomet's fourth quarter 2023 earnings conference call. Joining me today are Ivan Tornos, our President and CEO; and CFO and EVP, Finance, Operations and Supply Chain, Suky Upadhyay. Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by the forward-looking statements due to a variety of risks and uncertainties. Please note, we assume no obligation to update these forward-looking statements even if the actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties in addition to the inherent limitations of such forward-looking statements. Additionally, the discussions on this call will include certain non-GAAP financial measures, some of which are forward-looking non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures and an explanation of our basis for calculating these measures is included within our Q4 earnings release, which can be found on our website, zimmerbiomet.com. With that, I'll turn the call over to Ivan. Ivan?
Ivan Tornos:
Hey, thank you, Keri, and thanks, everyone for joining the call here this morning. I like to start the way that I typically do, taking a moment to recognize, to show my gratitude to the almost 20,000 Zimmer Biomet team members for their dedication, for their commitment, for their strong resilience, and for their superb performance in 2023. Simply put, 2023 was just a great year for our company and I want to say thank you. In 2023, we impacted the lives of almost 4 million patients and along the way we deliver best-in-class financial performance, growing our constant currency revenue by 7.5% while adjusted EPS earnings per share grew almost 9.5% in the year. That's 200 basis points of leverage between the 7.5% revenue growth and the 9.5% growth in EPS. In the year, we generated almost $1 billion in free cash flow, and that's with some turbulence around inventory management and whatnot. So again, strong performance top to bottom. And I'm just very, very proud of the execution in the year. It's worth noting that, that this level of execution and performance came in a year in which we still had to deal with fairly complex micro issues, whether it's inflation, FX, geopolitical challenges. I don't think I need to talk much about that and also some micro challenges in the year. We did struggle with some supply challenges throughout some of the periods. I'm happy that's behind, but it was a headwind in many periods in 2023. And again delivering 7.5% in 2023 against some top comparables, having grown constant currency revenue in 2022 the year before by 6.6%, so clearly a great trend in the making, clearly strong performance, and I'm just so grateful and so proud of all of you, the Zimmer Biomet team. At the same time, beyond grateful, I'm truly excited as I know that this is just the very beginning when it comes to the level of performance that we can realize here at Zimmer Biomet and multiple drivers of why I'm confident that this is just the very beginning. But I'll start with highlighting the bold pipeline that we have in place. The size of our pipeline is twice what it used to be in 2018. We got great new product launches that are happening here early in 2024. We have a stable supply, we've created an stable supply environment and we got great commercial execution. We're developing flawless commercial execution as evidenced by these growth rates that I just highlighted. To compound our belief behind this level of examine ahead is the fact that we have seen and we continue to see a substantial improvement in our end markets. This is not the same market growth profile that we used to have. Pacing demand is strong, procedure volume is very strong, given a variety of reasons and as the market leader in both knees and hips, being in better markets is just very exciting as we enter 2024. Back five years ago, when I joined the company, we used to think of for WAMGR weighted average market growth rates as being somewhere in the 3% range. And today, we PEG or WAMGR as being very near, if not at 4%. And again, that's a meaningful increase and we believe it's sustainable. So we're not going back to the 3% days when it comes to market growth rates. So again, internal and external dynamics gives me, gives us confidence that the best is truly ahead. When you add to all of these variables, the fact that we have the strongest balance sheet in the history of the company, there is no doubt then that we can claim that our future is nothing short of truly bright. So again, very pleased, very proud and very confident. I'd like to thank our investors as well for their support in 2023 and for their confidence in 2024 and beyond. We continue to take biggest strides forward toward being a company with a very different growth profile from top to bottom. Committing to an expectation to grow at least 100 basis points to 200 basis points above marketing revenue, with our EPS, with our earnings per share, growing faster than revenue, and our free cash flow dollars growing faster than EPS. The guidance that we are providing today for 2024 already reflect such a commitment to this type of financial discipline. And I'm very much looking forward to our Analyst Day on May 29 in when we will provide additional details in terms of our long range plan, which will illustrate that this is not a one-year wonder, this is a multi-year commitment. And you will see then that Zimmer Biomet has truly entered our growth stage era. We're no longer in turnaround mode. We're ready to deliver by being laser-focused on the three strategic imperatives that I highlighted during my very first earnings call as CEO back in November, three strategic imperatives that I continue to repeat over and over at every Zimmer Biomet meeting. And frankly, I will continue to repeat because those are the three drivers that we know are going to drive our performance. Those being number one, people and culture; number two, operational excellence; and number three, innovation and diversification. So let's talk about our 2024 commitments, how different initiatives across these three strategic imperatives will drive our growth forward. First in the area of people and culture, and again, I've explained this in the past, what it means, it's about having the right people in the right roles within the right culture. We must make sure that we support team members to act as owners and operators of the business. This means decentralizing decision making, driving agility, and empowering team members at every level, across every function around the world. We must become leaner; we got to be closer to the customer. Equally important, we must truly live an environment of pay for performance. This is something that has already kicked off in a very meaningful way in the fiscal year -- in this fiscal year 2024. An example of that is the fact that we're incentivizing free cash flow dollar generation or growth in a much more disciplined way across the enterprise knowing that revenue is also the most durable driver of free cash flow performance. Incentives are also set for revenue growth to meaningfully drive compensation across our firm at every level. So again, we change the way we pay people in terms of growing revenue above market. We change the way that we pay people, giving a larger percentage of compensation in adherence to the fact that we as a company need to grow free cash flow dollars at double-digit rates. In the second area of operational excellence, and again, this is about how we think about growing the business top to bottom. You can see already in today's update in the press release that we mean it. It is tough to restructure a company. It's certainly something that we don't take lightly. You read the press release, we had to do it. It's a tough choice once again, but we needed to make operational changes to simplify our structure, to deliver greater efficiency, and to ensure that we enhancing investments in the right areas of the business, again closer to the customer, so again, not an easy thing to do, but something that we had to do and something that we have done. Beyond the restructuring, other initiatives in the area of operational excellence that are already in full motion, are the new programs that we got in place kicking off how to drastically reduce inventory levels at Zimmer Biomet. This will drive substantial improvement in our free cash flow dollar growth, while also reducing our days on hand, DOH by 50 days or more and will reduce or excess an obsolescence exposure, which is something that frankly we've not done that well in previous years. Second thing we're doing is the rollout of a global initiative to drive new product launch excellence across the key new product introductions that we have in the year 2024. In simple terms, the seven or eight most meaningful product launches, let's make sure we have a cadence of operating mechanisms with proper governance to ensure that we're maximizing these product launches across each key geography. And then the third thing we're doing in operational excellence beyond the restructuring is the integration of the pricing organization under the finance structure, reporting directly to Suky, our CFO, to ensure maximum governance and accountability across the enterprise. While we are pleased with the reduction in price erosion over the last two to three years, we believe there is much greater opportunity to drive even better and more durable pricing dynamics. So again, in the area of operational excellence, beyond the restructuring, it's about drastically reducing inventory levels to generate improved free cash flow dollar growth. It's about governance beyond or behind the new product launches. And then thirdly is around doing better in the area of pricing dynamics. In the third strategic imperative of innovation and diversification, we're going to continue to invest in innovative R&D, in customer centric R&D, we're going to continue to fuel our pipeline with meaningful product launches. We're going to continue to drive our vitality index, which has already expanded very meaningfully over the last three years. And we're going to make sure that as we continue to launch new products, we also see margin expansion coming from these new products. I'm excited about where we are today. Our pipeline, the dollar value associated with our pipeline is twice what it was at the end of 2018. And as we enter 2024, we had very meaningful product launches, particularly in the hip area in where we lost market share in the last two years, given the lack of products in key categories like surgical impactors, triple tapered stems, or hip navigation. So again, 2024 is the year in where, through very meaningful product launches, we will regain the momentum that we lost. Beyond hips, I'm excited about where we are in shoulder; Identity continues to generate great excitement. We will enter 2024 in full launch mode when it comes to Identity. We're excited about stemless shoulders entering the market, and yes, very excited about being first to market in the category of shoulder robotics with a very highly differentiated offering in robotics for shoulders that will apply for both anatomic and reverse surgeries. In the area of knees, we're in the early days of our cementless knee launch, in 2024, we seek to increase our penetration rates drastically. Here in the U.S., our penetration rate in cementless is not even in the 20% range and we are committing to drive the penetration rate into the 50% to 60% range at a very rapid pace. Again, more details to those plans at our Analyst Day, but rest assured that our knee penetration rate in the cementless category is not going to stay in the teens or even the low-20s for long. Beyond cementless, we're excited about next-generation robotics in knee. We are excited about partial cementless knees, and we're excited about the fact that in 2024, we're going to be entering the full launch for Persona IQ, the only smart knee in the world that fully integrates data, technology and best-in-class implants in a way that nobody else is doing. In the category of S.E.T., which is six different businesses, sports, foot and ankle, restorative therapies, trauma, extremities, and CMFT, craniomaxillofacial thoracic, we are seeing great growth already exiting 2023. The second semester of 2023, we grew S.E.T. by mid-single-digit or above. And as we entered 2024 and beyond, the expectation is that S.E.T. will continue to grow mid-single-digit or above. And this is something that as a company, we've not realized ever since the merger in 2015 with exclusion of the post-COVID year given comes, so really excited about the return on the multiple investments we made in S.E.T. particularly in the areas of innovation and commercial execution. There is a great cadence of product launches in S.E.T., already mentioned some of those and more to come when we do our Analyst Day in later in the spring. So excited about S.E.T., excited about innovation as a whole or new product development pipeline is strong. We're going to be launching over 40 different new products in the next 24 months or so. Most of them are going to enable category leadership, establishing Zimmer Biomet as the leader or the second position in the category. And virtually all of them are going to be in market spaces that are growing 4% plus or above. So I like the quantity, I like the quality, and I like the market growth profile in terms of where innovation is going. I'm also particularly excited about the innovation plans that we have for the ASC here in the U.S., ASC side of care. We made meaningful investments innovation during all stages of the episode of care, what happens before surgery, what happens during surgery, and what happens after surgery. And relative to the ASC in the intra op stage of the ASC, we are best-in-class when it comes to solving problems, delivering efficiency, best-in-class outcomes and safety. So again, truly excited about our ASC strategy where we're going relative to this side of care. Diversification of Zimmer Biomet's end markets will happen not just by innovation internally, but will happen through smart M&A, which will remain the number one category when it comes to capital allocation, with a best-in-class labor ratio, and with deep confidence in our free cash flow generating plans over the next few years, our strategy is to make a smart M&A the top recipient of our capital. But at the same time, I just love the fact that we have the optionality to continue to do share buybacks as we announced this morning and perhaps at a more meaningful level. So the combination of smart M&A and buybacks can coexist, given the strong free cash flow dollar generation that we are seeing in -- from this regard. I'm energized by the very detailed and focused plans that the team has put in place, which I know that upon their execution will position Zimmer Biomet to deliver on the growth profile that we keep recommitting and that is to grow above to 100 basis points to 200 basis points. So that's a minimum point of entry commitment of 5% in the year 2024, with earnings per share always growing faster than revenue and free cash flow always growing faster than EPS. This is not a one year commitment. This is a multi-year commitment. And again, I know based on the very detailed plans, we will get there. In closing, we are very excited about where we're at, the track record over the last two years, and most importantly, we're deeply excited in terms of where we're going to go in 2024 and beyond. The team is ready. We are establishing the right trend and we're going to continue to drive flawless execution, delivering our commitment. Along the way, we're going to help patients, we're going to create shareholder value, and we will leave our mission of alleviating pain and improving the quality of life for people around the world. With that, I'll turn the call over to Suky.
Suky Upadhyay:
Thanks, and good morning, everyone. As Ivan mentioned, our fourth quarter results ended a successful year for Zimmer Biomet, with full-year constant currency revenue growing 7.5% and adjusted earnings growing more than 9.5% on reported basis, while generating just under $1 billion in free cash flow. Inside of that, our business segments performed well for the year. Global knees constant currency growth of over 10%, hips growth of 5%, and S.E.T. growth of almost 4%, all while also expanding adjusted operating margin by almost 100 basis points, the second consecutive year of operating margin expansion in a challenging environment. Also, as previously guided, we closed the second half of 2023 with mid-single-digit revenue growth and levered earnings growth, a profile we expect to continue moving forward. Let's dive into the fourth quarter results. Unless otherwise noted, my statements will be about the fourth quarter of 2023 and how it compares to the same period in 2022, and my commentary will be on a constant currency and adjusted operating basis. Net sales in the fourth quarter were $1.94 billion, an increase of 6.3% on a reported basis and an increase of 6.1% on a constant currency basis. We had a selling day tailwind of about 100 basis points in the quarter. U.S. growth was 4.4% and international growth was 8.7%. As expected, we saw a robust sequential step up versus the third quarter across all regions. Global knees grew 5.6% in the quarter with the U.S. growing 5.4% and international growing 5.8%. The knee business continues to be driven by our Persona product portfolio combined with our ROSA robotics platform, and we remain excited about the positive feedback around our recently launched cementless form factor for Persona OsseoTi. For the full-year, global knees grew 10.2%. Global hips grew 3.6% in the quarter with the U.S. growing 4% and international growing 3.2%. We are eager to accelerate performance of this segment with the addition of multiple new product offerings in 2024. For the full-year, global hips grew 5.1%. Next, the S.E.T. category grew 6.4% in the quarter, with our key focus areas of sports, CMFT and upper extremities all growing in the mid-single-digit to low-double-digit range. The strong growth in these focus areas was partially offset by other sub segments within the category. For the full-year, S.E.T. grew 3.8%, including a step up to mid-single-digit growth in the second half of the year. Finally, our other category grew 15.9% in the quarter, driven by another strong quarter of global ROSA sales. Now moving to the P&L. In Q4, we reported GAAP diluted earnings per share of $2.01 compared to GAAP diluted loss per share of $0.62 in the prior year. The increase in GAAP results was driven by higher revenue, a goodwill impairment charge in 2022 that did not repeat favorable one-time tax benefits in 2023, and a lower share count. The details around our financial performance can be found in today's press release. On an adjusted basis, we reported diluted earnings per share of $2.20 compared to $1.88 in the prior year, representing year-over-year reported growth of 17%. The step up is driven by revenue growth, better gross margins, lower OpEx margin in tandem with a lower tax rate. Our adjusted gross margin was 72.5%, up 80 basis points from the prior year, driven by favorable mix, higher volumes and lower royalties. And for the full-year we came in slightly above expectations, representing 90 basis points of year-over-year expansion. Adjusted operating margin was 30.3%, up 200 basis points from the prior year. The year-over-year operating margin step up was primarily driven by revenue leverage, better gross margin and realized efficiencies across SG&A. For the full-year, operating margin was slightly ahead of expectations at 28.2%, up 90 basis points year-over-year. Net interest and other adjusted non-operating expenses were $43 million in the quarter and $194 million for the full-year, and our adjusted tax rate was 15.8% the slightly more favorable tax rate was driven by discrete one-time items in the quarter, bringing our full-year tax rate to 16.3% and in line with overall expectations. Turning to cash and liquidity, we generated operating cash flows of $588 million and free cash flow totaled $447 million and we ended the year with cash and cash equivalents totaling $416 million. As Ivan mentioned earlier, we completed a $500 million share buyback program in early 2024, which is more than required to offset annual dilution. For the full-year, we generated operating cash flow of just under $1.6 billion and free cash flow of $979 million. Our balance sheet remains strong; leaving us continued financial flexibility and strategic optionality as we move forward. Now moving on to our financial outlook for 2024. Our outlook takes into account certain key assumptions, including pricing, which is expected to be about 100 basis points to 150 basis points of erosion, but it's a continued step change improvement from historical trends. We expect to see continued strength in our end markets in tandem with new product introductions and continued improvement in product supply. Against that backdrop, we expect 2024 constant currency revenue growth of 5% to 6%, including a foreign currency exchange headwind of approximately 50 basis points, translating to reported growth of 4.5% to 5.5%. Adjusted diluted earnings per share in the range of $8 to $8.15 representing reported growth of 6% to 8%. And currency is expected to have about an $0.08 headwind on EPS based on recent rates and the implementation of Pillar Two has an $0.18 or about a 250 basis points headwind on earnings per share growth for the year. This implies operating margin expansion of greater than 50 basis points at the EPS guidance mid-point when compared to 2023 We expect slightly lower year-over-year gross margins to be more than offset by efficiency and restructuring programs that were initiated in 2023. Net interest and other non-operating expenses are expected to be about $205 million and as previously discussed, our effective tax rate is expected to step up to 18% in conjunction with the implementation of Pillar Two. We expect to end the year with about 207 million shares outstanding lower than 2023 due to the $500 million share buyback plan that I've referenced earlier. Finally, we expect our free cash flow to be in the range of $1.50 billion to $1.1 billion, or growth of about 10% at the mid-point. As Ivan mentioned, we initiated a global restructuring program along with other cost savings initiatives in late 2023. These programs further streamline our organizational structure, shift select reporting lines, prioritize how we spend across the organization, and further evolve our operational footprint in order to simplify and maximize efficiency. This program is expected to result in total cash charges of about $125 million to $150 million over the next two years and deliver up to $200 million in run rate savings as we exit 2025, enabling us to invest in priority areas, while driving margin expansion and earnings leverage despite a meaningful step up in tax rate. In terms of cadence through the year, we expect constant currency revenue growth for the first half of the year to be at the lower end of the mid-single-digits, while the second half will be at the higher end of mid-single-digits. Also, quarterly results are expected to be choppy due to billing day impacts. Q1 will be about 150 basis point to 200 basis point headwind, Q2 and Q3 will be 150 basis point tailwind in each quarter and Q4 will be a 50 basis point tailwind. Full-year impact will be immaterial or less than 50 basis point tailwind. 2024 gross margin is expected to set down slightly versus 2023 due to lower FX hedge gains and the realization of capitalized third-party manufacturing cost increases observed in the second half of 2023. From a cadence standpoint, gross margin will be higher in the first half of the year. Additionally, because of the timing of the restructuring program, we expect operating margin will be higher in the second half than in the first half with Q4 being our high watermark followed by Q2. In summary, 2023 was another strong year for the company and we expect to maintain that momentum into 2024 and beyond. With that, I'll turn the call back over to Keri for the Q&A.
Keri Mattox:
Thanks, Suky. Before we start the Q&A session, just a quick reminder to please limit yourself to a single question and one brief follow-up so that we can get through as many questions as possible during the call. With that operator, may we have the first question, please?
Operator:
We'll go first to Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
Hi, good morning. Thanks for taking the question. Ivan, congratulations on a nice first year here as CEO. I'd love to ask about the 2024 guidance. Just talk about the key assumptions for the 5% to 6% constant currency growth in 2024. What you're assuming for the recon market. And Ivan, talk about your guidance philosophy. Have you incorporated any conservatism in the guidance? What would get you to the high end of the range? And just quickly, Suky, on the buyback, the $500 million, does that imply that it's hard to find good M&A targets? How should we interpret that? Thanks for taking the question.
Ivan Tornos:
Hey, thank you, Larry. Always great to hear from you. So I'll take the first two parts and then Suky can talk about the rest. So embedded in the guidance for 2024, which we're very confident on the 5% to 6% is macro and micro reasons. So from a macro perspective, by now you heard from most of our peers, the markets are very healthy. We believe beyond the backlog, the markets are going to continue to be healthy. You got better patient demographics, younger patients; you got the dynamic of cases moving into an ASC. You got more days of surgery in the U.S. where it's not just two days you see in three days. You've seen shorter, better rehabilitation processes. I can go on and on, but the markets are very healthy. And then from a micro perspective, we got a cadence of new product launches. Most of them are going to be very meaningful as you hit the second semester of the year. We got three new product launches in hips early in 2024, which again will be more material later in the year. We launched in ROSA shoulder. We got a cadence of new product introductions in S.E.T. We're going to continue to increase or penetration in cementless and ROSA. So again, the combination of new product launches, great commercial execution, amplified by the healthier market dynamics, gives us confidence on a minimum 5% and a range of 5% to 6%. Relative to my philosophy when it comes to guidance is very basic. We make commitments and we don't miss them. So we study the different dynamics. We study where we're at. We know that operationally we're in a better place. We don't have the headwinds that we had in 2023 around supply and whatnot. So my guidance represents or exemplifies my philosophy of making commitments and delivering on those commitments. I'm not going to comment today on whether there is opportunities to beat and raise for the year. I just leave it at my philosophy is to make commitments and deliver commitments, and these are very well studied commitments. So with that, I'll pass it on to Suky for your second question.
Suky Upadhyay:
Yes. Hey, good morning, Larry. Thanks for the question. I say, first of all, the $500 million share buyback; I think demonstrates our confidence in our outlook in the business. And the short answer to your question, does this imply some deterioration in M&A targets? And I would say absolutely not. I think based on where the company is from a firepower perspective; we feel that we've got the balance sheet strength and power as well as the forward-looking results. To really do both, we still will prioritize smart M&A as Ivan has talked about; we still favor tuck-in acquisitions to mid-size acquisitions. But even in the backdrop of doing heightened level of share buyback, we still see very significant M&A firepower to execute that strategy as well. So short answer again is no. We don't see this as any type of deterioration in targets.
Larry Biegelsen:
All right. Thanks for taking the question.
Keri Mattox:
Thanks, Larry. Yes, thanks so much. Katie, can we go to the next question in the queue?
Operator:
We'll go next to Matthew O'Brien with Piper Sandler.
Matthew O'Brien:
Good morning. Thanks for taking the question. Just maybe start a little bit, Ivan or Suky on the knee performance in this quarter. It was a little bit below what we were expecting, still better than one of your competitors, but below another one on a two-year stack basis, it's not quite 50% of sales, but close to it. So I would anticipate that that's going to need to see very good performance here in 2024 in order to hit the guidance range, which I think is maybe being questioned a little bit this morning. So what is it there specifically between cementless, between robotic, between Persona IQ that gives you the confidence in the knee franchise outside of the macro environment here in 2024? And then I do have a quick follow-up.
Ivan Tornos:
Thanks, Matt. So performance relative to the quarter, we're very pleased with the quarter. We perform in line with our expectations for knees and frankly for the entire business, and for the year, it was a solid year with a knees growing double-digit and the entire business growing 10.5% with nice EPS expansion. We really don't pay acute attention to what happens to one quarter. I know that it's our job to do that, but we just don't. The 60 to 62 working days in a quarter, all kinds of volatility, then you add comps. So when it comes to performance, we look to 8 to 12 quarters. And if you do run the analysis 8 to 12 quarters, you're talking about knees, but take a look at S.E.T. hips and whatnot, the performance is there. Speaking of volatility in Q4 for knees, we did see in the U.S. we did see some tons of orders. That impacted some of our largest IDNs here. We also had, let's remember, some tougher comps versus Q4 of 2022 particularly in the U.S. where we were 500 basis points ahead of our strongest competitor in knees. And again, if you look at Q3 that's a quarter where both the knees and hips we outperformed all competitors in the U.S. So again given all this volatility, all these ups and downs we just don't pay attention to one particular quarter. We look acutely at the trends and the trends do show that, 50 years later, we continue to be the number one player in knees and we continue to gain market share. Relative to the second part of your question around 2024, what gives us confidence around the guidance is the fact that we continue to see increases in cementless penetration. We continue to see increases in ROSA penetration. We have solved the backorder challenge that we had in this, which was a headwind for many periods in 2023. And we've seen this great commercial execution in the ASC. So we're very confident about where we are in knees and we are very confident around the acceleration in knees going into 2024.
Matthew O'Brien:
Appreciate that. Follow-up is just on there's a lot of good things coming this year as far as new products, et cetera. But you're trying to lower inventory levels significantly, 50 days of ton in this space. And then, the restructuring as well. Those -- how you factored in those potential headwinds in 2024 and even into 2025 in terms of potentially some lost revenues or dislocation you may suffer as a result? Thank you.
Ivan Tornos:
Thank you. Well, let me just begin with a simple answer. Anything and everything we're doing, restructuring wise and inventory management wise is embedded in the guidance we give it. So that's part of that. In terms of inventory management or inventory reductions, we're going to be bold but not reckless. So we're not reducing inventories in the key categories. We actually are making sure that inventory is what it needs to be for those key brands, whether it's Persona, whether it's the key components in hip, whether it is the key components in S.E.T. This is a lot of the leftover from the integration that we didn't do. So the inventory reduction is going to be in non-critical areas, frankly, in non-critical countries. So again, we're doing this thoughtfully. In terms of the restructuring, the reductions that we announced this morning, these are happening in back office. I will tell you virtually all reductions are non-customer facing. And again, the changes we make in inventory and people are embedded in the guidance that we're giving.
Keri Mattox:
Thanks, Matt. Katie, can we go to the next question in the queue, please?
Operator:
We'll go next to Robbie Marcus with J.P. Morgan.
Robbie Marcus:
Great. Thanks for taking the questions. I want to ask on S.E.T. and other. Those were the two line items that beat versus the Street. Was just hoping you could breakout some of the trends there, what did well, what might have underperformed, if anything, and how we think about those different line items as part of the guide in 2024 and how much of the strong growth is coming from that versus hips and knees. Thanks.
Ivan Tornos:
Hey, thank you, Robbie. So solid quarter for S.E.T. frankly, solid last semester of 2023 for S.E.T. growing around mid-single-digit, around 5%, and committing to growing mid-single-digit or above in 2024. The key drivers are the use of suspects. We continue to do really well with upper extremities growing upper single-digit, double-digit in most geographies, that's new product launches, that's focusing the ASC, that's stable supply, just great commercial execution. Our CMFT business, craniomaxillofacial thoracic, continues to do really well. We call that we did two, three acquisitions over the last three years, and those continue to do really well. And again, CMFT is a business where we see upper single-digit, double-digit. We finally stabilize our restorative therapies business here in the U.S. Recall that we had some reimbursement challenges there, and those are behind. So you've seen the biologics restorative therapy business growing at a nice clip now. And then sports med, we've done some acquisitions. We have had some challenges, but that continues to perform in line with expectations. So I will tell you, Robbie, out of the six businesses within the category, four are going really well. Trauma put an ankle; we got some work to do. We got some decisions, some strategic considerations to make. As we enter 2024, mid-single-digit is the point of entry. This has to be the year where we see S.E.T. growing mid-single-digit. Frankly, in some geographies, I think it's going to be higher than that. We got the innovation; we got the investments in terms of dedicated infrastructure and specialization, heavy emphasis here in the U.S., in the ASC environment. So again, full confidence in the growth profile that we're going to see moving forward.
Robbie Marcus:
Great. Thanks. Maybe just a quick follow-up for Suky on the guidance and a clarification. The lower end of mid-single-digit in the first half and then higher end second half. Is that inclusive or exclusive of the selling day benefit? Thanks.
Suky Upadhyay:
That is inclusive of the selling day benefit, Robbie.
Robbie Marcus:
Okay. Thanks a lot.
Ivan Tornos:
Yes.
Keri Mattox:
Thanks, Robbie. Katie, can we go to the next question in the queue, please?
Operator:
We'll go next to Joanne Wuensch with Citi.
Joanne Wuensch:
Excuse me. Good morning and thank you for taking the questions. Putting them both right up front. I'm curious why gross margins are expected to be somewhat down year-over-year, what the dynamics are for that? And then my second question has to do with cementless. Can you walk us through the math of what you think moving to 50% to 60% of your knees being cemented or cementless, excuse me, either way 50%. What the benefit is of that? Thank you.
Suky Upadhyay:
Yes. Hey, Joanne, it's Suky. I'll start with the gross margin one and then pass it over to Ivan on cementless. Overall, we had a really good year on gross margin in 2023, up 90 basis points year-over-year. Drivers of that are really around we had some FX hedge gains, which we had talked about at length throughout 2023, as well as improved mix and better pricing, still, pricing erosive year-over-year, but better than we expected. Overall, generated a pretty nice profile for 2023. We had previously communicated that we had thought that gross margins might dip down slightly into 2024, primarily driven by the loss of those FX hedge gains. They won't repeat at the same level in 2024 as they did in 2023, but also we're seeing in the capitalization of some increased costs in the back end of 2023, around third-party manufacturing, which will feather into the P&L towards the back end of 2024. Despite those two headwinds, we're able to offset a large component of that, but overall, we do expect to see gross margins down just slightly ZBH-009 restructuring, the reductions that we announced this morning, these are happening in back office. I will tell you virtually all reductions are non-customer facing. And again, the changes we make in inventory and people are embedded in the guidance that we're giving.
Keri Mattox:
Thanks, Matt. Katie, can we go to the next question in the queue, please?
Operator:
We'll go next to Robbie Marcus with J.P. Morgan.
Robbie Marcus:
Great. Thanks for taking the questions. I want to ask on S.E.T. and other. Those were the two line items that beat versus the Street. Was just hoping you could breakout some of the trends there, what did well, what might have underperformed, if anything, and how we think about those different line items as part of the guide in 2024 and how much of the strong growth is coming from that versus hips and knees. Thanks.
Ivan Tornos:
Hey, thank you, Robbie. So solid quarter for S.E.T. frankly, solid last semester of 2023 for S.E.T. growing around mid-single digit, around 5%, and committing to growing mid-single digit or above in 2024. The key drivers are the use of suspects. We continue to do really well with upper extremities growing upper single-digit, double-digit in most geographies, that's new product launches, that's focusing the ASC, that's stable supply, just great commercial execution. Our CMFT business, craniomaxillofacial thoracic, continues to do really well. We call that we did two, three acquisitions over the last three years, and those continue to do really well. And again, CMFT is a business where we see upper single-digit, double-digit. We finally stabilize our restorative therapies business here in the U.S. Recall that we had some reimbursement challenges there, and those are behind. So you've seen the biologics restorative therapy business growing at a nice clip now. And then sports med, we've done some acquisitions. We have had some challenges, but that continues to perform in line with expectations. So I will tell you, Robbie, out of the six businesses within the category, four are going really well. Trauma put an ankle, we got some work to do. We got some decisions, some strategic considerations to make. As we enter 2024, mid-single digit is the point of entry. This has to be the year where we see S.E.T. growing mid-single digit. Frankly, in some geographies, I think it's going to be higher than that. We got the innovation, we got the investments in terms of dedicated infrastructure and specialization, heavy emphasis here in the U.S., in the ASC environment. So again, full confidence in the growth profile that we're going to see moving forward.
Robbie Marcus:
Great. Thanks. Maybe just a quick follow-up for Suky on the guidance and a clarification. The lower end of mid-single digit in the first half and then higher end second half. Is that inclusive or exclusive of the selling day benefit? Thanks.
Suky Upadhyay:
That is inclusive of the selling day benefit, Robbie.
Robbie Marcus:
Okay. Thanks a lot.
Ivan Tornos:
Yes.
Keri Mattox:
Thanks, Robbie. Katie, can we go to the next question in the queue, please?
Operator:
We'll go next to Joanne Wuensch with Citi.
Joanne Wuensch:
Excuse me. Good morning, and thank you for taking the questions. Putting them both right up front. I'm curious why gross margins are expected to be somewhat down year-over-year, what the dynamics are for that? And then my second question has to do with cementless. Can you walk us through the math of what you think moving to 50% to 60% of your knees being cemented or cementless, excuse me, either way 50%. What the benefit is of that? Thank you.
Suky Upadhyay:
Yes. Hey, Joanne, it’s Suky. I'll start with the gross margin one and then pass it over to Ivan on cementless. Overall, we had a really good year on gross margin in 2023, up 90 basis points year-over-year. Drivers of that are really around we had some FX hedge gains, which we had talked about at length throughout 2023, as well as improved mix and better pricing. Still, pricing erosive year-over-year, but better than we expected. Overall, generated a pretty nice profile for 2023. We had previously communicated that we had thought that gross margins might dip down slightly into 2024, primarily driven by the loss of those FX hedge gains. They won't repeat at the same level in 2024 as they did in 2023, but also we're seeing in the capitalization of some increased costs in the back end of 2023, around third-party manufacturing, which will feather into the P&L towards the back end of 2024. Despite those two headwinds, we're able to offset a large component of that, but overall, we do expect to see gross margins down just slightly versus 2023 in the backdrop of those headwinds. Now, having said that, if you take the mid-point of our EPS guidance, I think that would back you into an implied operating margin of about 29%, which represents about an 80 basis point increase year-over-year. And so while gross margin may set down slightly, you are seeing operating margins increase as we drive better efficiency and revenue growth through the company. So again, there are a lot of puts and calls throughout the P&L. The great thing is we've got optionality where we see headwinds in one area. We can make that up with efficiency and tailwinds in other areas. I think you've seen that now, once we deliver 2024 three years in a row, which in a challenging environment, in all three years, we're able to continue to grow operating margin and operating earnings. But thanks for the question.
Ivan Tornos:
And Joanne, relative to your question on cementless, I'll give you as much as I can. So, starting with the basic pricing dynamics we see with cementless Persona OsseoTi, we see an ASC uplift of around 10% to 15%, frankly closer to the 15% than the 10%, around 40% to 50% of the time, we combo the cementless knee with robotics, with ROSA, and that drives additional uplifting revenue in the form of disposals and whatnot. So that's a great dynamic we see in particular in the ASC. Our penetration today on cementless, we're exiting 2023 somewhere near 18% to 20% with both expectations; excuse me, to get into the 50% to 60% range. And I'm not going to give you a commitment today, but at our Analyst Day, you will see the long range plans and some of the trending when it comes to getting to 60%. We believe that there's going to be a fairly quick uplift, given the fact that the market is already being developed by some of the work that our peers have done. So again, you should not expect that getting to 50% to 60% is going to be a long journey. All of these dynamics are in the U.S. We're launching in 2024 in other markets outside of the U.S., and I will disclose the pricing dynamics when the time is right. But excited about the launch in Japan in 2024 and other key markets. So those are the dynamics here when it comes to cementless.
Joanne Wuensch:
Thank you very much.
Keri Mattox:
Thanks, Joanne. Yes, absolutely. Katie, can we go to the next question in the queue?
Operator:
We'll go next to Ryan Zimmerman with BTIG.
Ryan Zimmerman:
Thank you. Thanks for taking the questions. Following-up, maybe on Larry's questions about guidance, you talked about the WAMGR being at 4%, and clearly we're in this stronger market environment. And so as I think about the components of guidance with pricing as a headwind of 100, 150 basis points, it suggests product mix is going to contribute 200 basis points to 300 basis points. I just want to see one if that's how you're thinking about it, or if you're thinking about the market contribution to guidance at a higher rate in 2024 and maybe potentially the product mix contribution lower. Maybe just help us flush a little that out.
Ivan Tornos:
Yes, I'll try to simplify it. And Suky, by all means elaborate, but we believe the market is around 4% all in. And again, we model this in different ways, but let's call it 4%. I'm not going to quantify the new product contribution, but pretty significant. We got 40 new products getting launched in the next two years, and these are meaningful products. I mentioned we got three large hip products that are going to get launched early in 2024. We got ROSA shoulder, which we believe is going to be meaningful in the year 2024, given the fact that it's not a late year launch. We got a lot of products in the S.E.T. category. So again, you should think of new product introductions as a very meaningful contributor of the guidance. Add to that the fact that we don't have the headwinds that we had in 2023 when it comes to supply, I would say between number one and number two; we got confidence on where we're going. Beyond that, we don't see a headwind when it comes to the shift to the ASC. We actually see that as a tailwind. We're excited about some of the dynamics we're hearing about when it comes to the movement of shoulders into the ASC. That's going to be a contributor. And as I mentioned to Joanne, the uplift that we see on cementless and ROSA, which are products that we launched three years ago but now going to get accelerated are the main contributors to the confidence in the guidance. I don't know, Suky, you have anything else here?
Suky Upadhyay:
I think that's well said. One of the key points Ivan you touched upon, you said, pricing erosion is assumed in that 4% uplift.
Ryan Zimmerman:
Right. Okay. That's helpful from both of you. And then just to kind of dovetail on Joanne's question around margins, you talk about gross margin, Suky. Clearly operating margins are doing more heavy lifting this year. And so how much from the restructuring program is benefiting, is driving some of that operating margin expansion? How much are you assuming for top-line leverage in that 80 basis points or so of expansion? And yes, that's about it. Thanks for taking the question.
Suky Upadhyay:
Yes. So the key driver with gross margin being sort of flat to down slightly, it really is coming from revenue leverage and operating margin. You could expect overall OpEx as a percentage of sales to drop by about 100 basis points, give or take. And that's even with R&D increasing year-over-year. So the efficiency and the restructuring programs in the near-term are really focused on SG&A. However, inside of that full program, we are working on things inside of COGS to help maintain and keep gross margin stable over time. Those are going to be a little bit more mid-term in nature and how they get realized. Things like SKU rationalization, site optimization, inventory reductions and corresponding D&O reductions, those are all things that have a little bit longer lead time, naturally, as you can expect as you're moving your supply chain around and not wanting to disrupt the ability to supply demand. But they are definitely is going to take more of a prominence as we move forward beyond 2024. But for 2024, the way you characterize is right. It's primarily revenue driven and SG&A.
Ryan Zimmerman:
Thank you.
Suky Upadhyay:
Yes.
Keri Mattox:
Thanks for the question, Ryan. Katie, can we go to the next question in the queue?
Operator:
We'll go next to Travis Steed with Bank of America.
Travis Steed:
Hey, thanks for taking the question. I want to ask about the $200 million in cost savings that you guys called out this year. Curious, is the plan for that to kind of drop through to the bottom line or are you going to reinvest that? And what does that mean for kind of margins beyond this year and longer-term?
Suky Upadhyay:
Yes. So the way we characterized it was that it would be $200 million run rate as we exit 2025. In year for 2024, we expect that to be about $100 million, or about half of the run rate savings that we're predicting over a two-year period. We're dropping a lot of that to the bottom line, as you can see with our implied guidance at the mid-point would suggest about an 80 basis point increase in operating margins. And so we're actually taking a good portion of that, dropping it to the bottom. But we're also reinvesting a pretty significant portion back into our priority areas, ensuring that we've got the appropriate amount of sets and instruments for cementless uptake as well as Persona uptake through ROSA. Ensuring that we've got the right level of commercialization and execution in our new ROSA shoulder launch, ensuring and ramping up commercialization efforts in our hip franchise around the product launches that we have for hip. So it really is a combination of both. And that's the great thing about this efficiency program. It enables us to reinvest back into our priority areas while dropping pretty significant, substantial margin expansion now, for the third year in a row.
Travis Steed:
Yes. Helpful. And on the new comp plan that you called out, curious if that's going to have an impact on margins or just not material enough to impact margins. And then on M&A, just curious if there's been any change on the two years of EPS solution from M&A.
Suky Upadhyay:
Yes. On the comp plan, it's not really going to have any material impact and it's embedded in our guidance. I think it's more about a mix shift of how that comp plan is designed, right, whereas previously it was more focused and biased towards revenue growth. I think now what we're trying to do is get a greater balance between top and bottom lines all the way through cash flow. So it's really a mix shift in how we think about comp versus an increase in comp. And again, all of that is embedded into our guidance for 2024. Relative to the dilution, we still think about two years from a dilution standpoint is reasonable. Of course, we'd like it to be inside of that. But just given where valuations are today, as well as the cost of debt, which hopefully is going to come down over time, that's kind of where we see one of our guard reps.
Travis Steed:
Great. Helpful. Thanks a lot.
Ivan Tornos:
Thank you.
Suky Upadhyay:
Yes.
Keri Mattox:
Thanks, Travis. Katie, can we go to the next question in the queue, please?
Operator:
We'll go next to Jeff Johnson with Baird.
Jeff Johnson:
Thank you. Good morning, guys. Congratulations on the quarter. Ivan, maybe you mentioned in passing that shoulder for ROSA is not going to be a late year 2024 launch. Just could you dial in that timing anymore? And I'd be interested in hearing about kind of your view on the uptake of ROSA shoulder, obviously, shoulder surgeries, replacements, technically more challenging. I think some questions about what role robots can initially play in those procedures. So just how does that help the uptake of ROSA? And I don't think I heard a ROSA placement number. I think sometimes you give it on kind of an annualized basis. Any updates on kind of exiting 2023 where ROSA placements were? Thanks.
Ivan Tornos:
Hey, thank you, Jeff. So I got to be careful what I say about time lapse for ROSA shoulder. I'll just say that I'm very confident that this is not a late 2024 launch. And as I mentioned, I think it's going to be very meaningful. So beyond being first to market, it's a high quality product. It's going to be applicable for both reverse and anatomic surgeries. It's going to simplify a very complex procedure. It's going to be fully integrated with the rest of the shoulder CVH ecosystem. I believe it's going to get great traction in an ASC environment where speed and accuracy matters. And we're going to hopefully demo these next week at the academy meeting. Whether it's ready or not, it will be demoed there at the academy meeting. Relative to your second question on the ROSA placements and the numbers, you should expect us to do around 300 installations per year. You should expect us to drive penetration rates of minimum 5% to 7% at least per year. You should expect that one-third of these ROSA -- overall ROSA installations are going to go into an ASC environment. And as I mentioned earlier to Joanne, you should expect that in a large percentage of cases, these ROSA installations are going to push cementless. So again, great momentum with ROSA and I'm very excited about where we are with shoulder.
Jeff Johnson:
Thank you. And maybe as a follow-up, just as I think about the 5% to 6% constant currency guidance and 100, 200 basis points above market, it seems like market is settling in at a good rate. If I think about gross margin, obviously some of the hedge settlements should normalize as you get into 2025 P&L coming down, pricing getting less bad. So it sounds like gross margin, at least not a big, big headwind going forward. And then of course, you've got the cost savings initiatives here on the SG&A side. If I roll all that together, including the improving balance sheet and cash flow and a commitment to some share buyback, it feels like 10%, 10.5% EPS growth, which is kind of the mid-point of your guidance this year. If it weren't for tax rate and FX headwinds, that sounds like it could be a sustainable kind of target. I'm sure you don't want to lay out an LRP here out of your Analyst Day, but is there anything in my thinking there that would say 10%-ish plus or minus is not a reasonable kind of longer-term EPS growth rate to be thinking about. Thank you.
Suky Upadhyay:
Hey, Jeff. I think that was actually a really good articulation and summarization of what we're trying to get across today. In fact, if you look at our guidance today on reported EPS, it would suggest 6% to 8% at both ends of the range. That's after overcoming about 400 basis points of headwind between non-operational things like interest expense, FX and tax rate, right. So again, that's about a 400 basis point drag that's embedded in that 6% to 8%. So the way you're thinking about it, could we be in that low-double-digit zip code on EPS in a sustainable, durable way? I think yes.
Jeff Johnson:
Thank you.
Keri Mattox:
Thanks for the questions, Jeff. Katie, do you have another question in the queue?
Operator:
We'll go next for Richard Newitter with Truist Securities.
Richard Newitter:
Hi, thanks for taking the questions. Just with AAOS next week, I was wondering anything that we should be on the lookout for with respect to canary or paternal few rather, and data presentations. I think you had also mentioned on a prior call you were expecting a GLP-1 kind of data analysis, possibly at AAOS and then I have follow-up.
Ivan Tornos:
So the answer is yes to both, Richard. So we will have some data points on Persona IQ, and we'll have some data on GLP-1. On Persona IQ, we moved from a limited market release in 2023 to full market release in 2024. We got the value proposition finalized. We got over 2 billion data points. We understand there's a product that is going to enable clinicians to intervene when needed. We got data points on how this product will reduce overall complexity in the episode of care. How we can by intervening soon reduce cost, especially post-surgery, when it can be pretty taxing. We don't reimbursement. We spoke about the NTAP new technology add-on payment, which we got back in October. So that's in full launch mode. We will submit. Barry always asks me this question. We will submit for a PPT coming some point in the spring, summer, and we're going to bring some data around, some of the experiences that we've seen with Persona IQ at the Cleveland Clinic, HSS and other facilities. So excited in terms of what we have with Persona IQ, more to come at the academy. And then for GLP-1s, yes, we're going to be sharing some of the data we've done in conjunction with the academy. And what I will tell you is that so far, everything we've seen with GLP-1s is that it remains a tailwind. We're actually tracking the number of patients that are using a GLP-1 pre-surgery, and that number is in the 20% to 30%. So by all means, this is not a headwind, and I'm glad that conversation is being muted.
Richard Newitter:
Great. And then just piggybacking off of Jeff's question, even with potential earnings dilution, if you're potentially going to be -- have the potential to be in a low-double digits or 10 plus earnings growth range, and I'm given your commitment to growing earnings faster than the top-line, where it sounds like 5% is kind of a sustainable floor, given your end market and your WAMGR it sounds like no matter what, even with dilution over a 1.5, two-year period, you feel confident, or we should feel confident in a high-single-digit earnings growth rate at worst. Is that also a reasonable assumption based on all the different commitments and commentary that you provided?
Ivan Tornos:
Well, I think what you're asking is, can you still sustain that in a world where you do a sizable M&A a transaction? If I've gotten that correct, that's really difficult to tell, right? There is no two deals are created equal. It's very situational. And so I don't want to get out there front footed to kind of hypothesize, theoretically, what could happen to EPS inside of a sort of make a new [ph] deal. So I think that what you should take away is that from an underlying perspective, at 5% to 6% organic growth, with the levers that we have operationally, but also with the strength of our balance sheet organically, that we can deliver that attractive earnings per share profile.
Richard Newitter:
Okay.
Keri Mattox:
Thanks, Rich. Katie, I think we have time for one more question if there's one in the queue.
Operator:
We'll go next to Jayson Bedford with Raymond James. Mr. Bedford, your line is open. Please go ahead. Please check your mute function.
Jayson Bedford:
Oh, sorry, I was off. Yes, sorry about that. I'll be quick. On the supply challenges that you incurred in 2023, can you just remind me what was the impact of these challenges on the P&L last year meaning, is there a way to quantify the impact on revenue?
Suky Upadhyay:
Yes. Hey, Jayson, it's Suky. It's a bit of more stress to try and say exactly how days on backwater really impact sales, because one, obviously you have an impact on actual cases, but the more meaningful impact is the ability for our sales rep to go out there and actually hunt for new business, right? They're going to be a little bit hesitant to go shift and make conversions if they don't feel like they can supply. So that's actually probably the bigger impact. But trying to frame that in percentage points is very difficult to do. The way I looked at it is the tailwind for last year. We believe it's part of the -- sorry, it was a headwind for last year, we believe it's part of the tailwind that's going to help give us confidence in delivering that 5% to 6% organic growth for this year.
Ivan Tornos:
Yes. We have some internal data points that we don't share. What I will tell you, Jayson is that new product launches, we had to do limited market releases instead of full market releases, Persona OsseoTi is an example. Conversion, as Suky mentioned, we had to prioritize or send some family customers versus converting accounts. And then the third headwind of supply, from a revenue perspective, we couldn't embark on global expansion of these new product launches. So the example that I used earlier around Japan, second largest market in the world, we could have done things differently. We could have been on the market. So it is sizable and it is behind us.
Jayson Bedford:
Okay. That's helpful. Maybe just along a similar vein, I think you talked about a 50 basis point impact to revenue growth in the second half from Russia. Is Russia a net tailwind as we look to 2024?
Suky Upadhyay:
It is. It is. I would say it's less than 50 basis points. But given that we now have all the licenses secured we need to operate, that that will be a tailwind probably most pronounced in the third quarter because that's when we saw the biggest impact in 2023.
Jayson Bedford:
Thank you.
Keri Mattox:
Thanks for the questions, Jayson. I think we're wrapped up with the queue and just hitting 9:30. So I'll turn it over to Ivan for some closing remarks.
Ivan Tornos:
Sure. Thanks, Keri. I'll keep it short. I know we got to get going here, so a minute or less. I want to start, I want to end the way that I started the call by thanking the team members, the almost 20,000 team members here at Zimmer Biomet who are doing a remarkable job in executing the plans that we lay forward. So grew 7.5% constant currency in 2023 with a nice EPS expansion of 200 basis points that's after growing 6.6% in 2022. And now we're committing to at least 5% revenue growth, 5.5% mid-point with nice EPS expansion and double-digit growth in free cash flow. So very proud of the work that team members are doing. And we're very excited about 2024. We are moving from remediation to -- we have moved from remediation to innovation. I'm excited about the pipeline of products. I'm excited about the financial profile that we commit into or growing EPS faster than revenue and free cash flow faster than EPS. And so far during the year, everything that we're seeing gives us confidence, or confidence that it's going to be a very solid year for Zimmer Biomet. So thank you for your attention this morning, and thank you, team members at Zimmer Biomet.
Operator:
Thank you for participating in today's conference call. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet’s Third Quarter 2023 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today November 7. Following today’s presentation, there will be a question-and-answer session. At this time, all participants are in a listen-only mode. [Operator Instructions] I would now like to turn the conference over to Keri Mattox, Chief Communications and Administration Officer. Please go ahead.
Keri Mattox:
Thank you, operator, and good morning, everyone. Welcome to Zimmer Biomet’s third quarter 2023 earnings conference call. Joining me today are Ivan Tornos, our President and CEO; and EVP and CFO, Suky Upadhyay. Before we get started, I’d like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by the forward-looking statements due to a variety of risks and uncertainties. Please note, we assume no obligation to update these forward-looking statements even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties in addition to the inherent limitations of such forward-looking statements. Additionally, the discussions on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within our Q3 earnings release, which can be found on our website, zimmerbiomet.com. With that, I’ll turn the call over to Ivan. Ivan?
Ivan Tornos:
Thank you very much, Keri. And good morning, and greetings, everyone from Warsaw, Indiana, the orthopedic capital of the world, welcome to our Q3 earnings call. My first call as the CEO [indiscernible] organization really grateful that all of you are joining us here this morning. I’d like to begin by sharing how truly excited I am to be in the new role. Team to be a very inspiring time, not just in musculoskeletal health, which it is, but also in med-tech in general. Simply put the space is not what it used to be just so five years ago. When you look at orthopedics, when you look at the entire category, it’s changed, it’s changed a lot. Groundbreaking technologies are shaping how procedures are done beyond the backlog and continuing femoral demographics, global demand for treatment is higher than it has historically been This is driven by better clinically reported outcomes. This is driven by shorter episodes of care. This is driven by better, more comfortable ways to do physical therapy. This is driven by greater ways to approach different disease states. And this is driven by subtle treatment migrations like the one we see here in the U.S. with a rapid shift of cases moving into an ASC while also preserving what are very compelling volume levels in the traditional in-patient and outpatient settings. So in plain English, healthy market, great patient dynamics, new technology, disruptive innovation, a lot has changed. And I don’t see us going back to four or five years ago. So again, a very inspiring time to be in musculoskeletal health and orthopedics in general. All of these market accelerating trends are opening new doors for countless patients to benefit from what we do here at ZB, which is to drive life changing solutions. And we do that every single day for countless patients. And the best part about it, we’re just getting started. So I could not be more excited to be here in my new role. With this encouraging market dynamics, sustainable trends, and building on the solid track record of execution that the ZB team has enabled. It’s great to be here today to report what it is, another solid quarter of a strong performance while strongly reaffirming our year-end guidance for the year 2023. Even more exciting, as I look forward to our future, I’m more convinced than ever that Zimmer Biomet will continue to lead the way on customer-centric innovation, already a competitive advantage and solid commercial execution, enabling not just the delivery of our mission, but also improving on our other key value creation drivers, those regaining and sustaining top quartile performance. And again, this is something that we treat with a lot of rigor and something that is a mandate for the organization. We must regain and sustain top quartile performance. For today’s call, I want to first share my thoughts on my first two months as CEO of Zimmer Biomet, while also providing key insights into what I’ve learned, how my learning has shaped what are going to be my three key priorities as the new CEO of the enterprise. This will answer the question on what is fundamentally going to change around here in the next chapter of our transformation. After that, I’m going to talk about the key drivers behind the solid Q3 performance, next Suky will take over, will discuss the financials for the quarter as well as the expectations for the rest of the year, and then our favorite part of the call Q&A. Before we move into these updates, I do want to take a moment to thank the global Zimmer Biomet team for their unwavering commitment to our purpose, to our plans. I want to thank them for their sense of urgency in driving site execution. I want to thank them for everything that they do. This is a highly engaged and focused team that is being operating at a very rapid speed and is eagerly designed to do even more, more for patients, more for customers, more for the team, more for each other, more for the company, more for the communities where we work and live, like right here in Warsaw, and frankly, far more for the shareholders. It’s a team that has gone through a lot, and a lot is a lot. This team has done a lot of heavy lifting, and now with the heavy lifting behind from a remediation standpoint, it’s great to be in a different stage and it’s great to be able to show to the world what the Zimmer Biomet team can do and will do. Beyond proud of the organization and I’m genuinely inspired by what they do each and every day. Been doing this for a while around the world, and I can truthfully tell you I’ve never worked with a better team than the one we have here at Zimmer Biomet. And again, I can hardly wait to showcase our results in quarters to come. So thank you. I also want to thank Bryan Hanson for all that Bryan lead to bring Zimmer Biomet to this moment. We are grateful and we’re stronger because of his leadership. So thank you, Bryan. Now let me share some perspective as the new CEO of Zimmer Biomet. During my first 11 weeks or 77 days in the job, I’ve spent significant time with team members, customers, analysts, investors, or Board, my peers, healthcare executives across med-tech, government officials, and other key stakeholders in healthcare so that I could listen, I could learn and I could get the property insights. I’ve been in every Zimmer Biomet region around the globe. I’ve interacted with every key manufacturing facility. I have visited hundreds of decision makers across every major continent, and I have collected countless pages of feedback and recommendations. Most critically, I’ve used this reflection time to ensure that we at Zimmer Biomet are boldly prioritizing what needs to get done. And this, I can assure you would be a trademark of my time as CEO of Zimmer Biomet, having the courage to say no to several things so that we can become truly great in those things that will drive the most value for the enterprise and our key stakeholders. These key priorities are purpose and people, number one. We have a winning culture. We have the absolute best talent in the industry. It has been a foundational priority for ZB and will continue to be critical under my leadership. People, purpose, talent, culture with a very data centric organization, and we use the same level of data centricity to track how it is that we’re doing with our human capital. To that end, we track level of engagement, development, DEI, engagement across different segments and geographies, high potential ratings and everything in between. I’m really excited to report that, or the most recent engagement survey, which we completed about six weeks ago delivered the absolute best scores in the history of the company. Let me say that again. The latest engagement score for organization close to 20,000 employees showcase the absolute best scores in the history of the organization, frankly, going up across every single category. This tells me that the team is energized. This tells me that the team is ready, and this tells me that the team is about to unleash a lot of greatness for the organization. The second priority is to create and sustain a framework of operational excellence across the Board. Simply put is about being great when it comes to running the business. This means simplifying what we do, where we play, and how we play. This means being courageous and bold about the choices that we make. It starts with being intention about driving sustainable revenue growth. We know this is the number one driver of top quartile performance, and we also know that innovation, customer-centric innovation and commercial execution are the two key drivers of sustainable revenue growth. So we’ll accelerate that, but at the same time, we’re not going to forget that we can and will do better across the entirety of the P&L. We’re going to drive a culture of ownership by every single employee across the globe. With all of us waking up every single day acting as true investors in the business and thinking of time and money as the key currencies of the organization. This means continuing to align our incentives with an even greater emphasis on best-in-class performance from both top and bottom. By delivering on operational excellence, as a mandate or mindset for the organization, we’re going to enable, number one, revenue growth of at least 100 to 200 basis points our market, while growing earnings faster than revenue and free cash flow growing faster than the rate of earnings. Number two, operational excellence will enable best-in-class supply and operational outcomes by simplifying a rather complex operations and manufacturing footprint. And then thirdly, operational excellence as a mandate is going to enable an agile, nimble, and simplify company that can anticipate – can be proactive in successfully navigating market trends. So again, operational excellence and mindset is going to deliver revenue growth of at least a 100 to 200 basis points of market while growing earnings faster than revenue and free cash flow faster than the rate of earnings, while enabling best-in-class supply and operational outcomes and by making Zimmer Biomet, agile, nimble, and a very simplified company that is proactive in what it does. Based on where we are, as we close the year 2023 and based on our latest guidance, we’re already on track to deliver the metrics that I mentioned above around revenue, earnings and free cash flow the way we’re run the company, but we expect to do it again with even greater rigor in 2024. To that end, we look forward to hosting an Analyst Day, something we’ve not done ever since we merged the two companies. And at that Analyst Day, we’re going to be sharing more details on these thought that I have highlighted and the specific drivers of these goals. So this becomes truly the DNA of Zimmer Biomet. Priority is about innovating and diversifying Zimmer Biomet into higher growth markets, table stakes. We must enter higher growth markets. We do need to diversify our portfolio, and we’ll do that. We’re going to do it through organic and inorganic means, we’re going to do it through innovation and M&A. On the innovation front, we’re going to innovate by continuing to boldly invest in the right segments of R&D, so that is new product development. So that we always think customer problems and bringing solutions to those problems. We’re going to make sure that those problems are in attractive growth areas that are mission-centric, but also are in the right markets. And by bringing those solutions, we’re going to become and remain market leaders in these categories where we choose to play aided by both product and solutions launches that will enable category leadership for Zimmer Biomet. We’re going to be relentless about the certain opportunities, namely the ASC opportunity here in the U.S. where we are already growing in the strong double-digit rates, but we know we are far from realizing our true potential. This journey, by the way, innovation journey has already started. We’re on track to launch over 40 new products over the next 36 months. And the value – the dollar value for pipeline today is twice the dollar value that we had back in 2018. So a lot of new exciting technologies are about to get launched here at Zimmer Biomet. In addition, 80% of our products in our pipeline, we’re studying markets that are growing at least 4%, many in areas that are growing more than 4%. Equally vital, we’re going to ensure that the innovation journey accelerates value creation through making sure that we monitoring not just the revenue associated with these launches, the vitality index, but also what we call our innovation profitability index or IPI, and that’s the gross margin dollars coming from new products. We got to make sure that these new products are driving margin accretion to the overall margin profile of the organization. So again, it’s about innovation and it’s about value creation at the same time. Mission and margin expansion will coexist and will coexist as part of our innovation journey. To materially change our portfolio, we’re going to also leverage the strength of our balance sheet, which is stronger than ever. We will do M&A. We’re going to be thoughtful and disciplined about the spaces we prioritize, and we’re going to ensure that the spaces are mission centric, and at the same time, these spaces are the areas where Zimmer Biomet has a right to win. We focus on opportunities that are going to hit strategic thresholds, but also hit financial thresholds. We’re going to make sure that these acquisitions drive a strong returns and create long-term shareholder value. It is worth noting that this diversification of our business has started already. Yes, we have to be bolder and we will be bolder, but it has already started. In the last two, three years, we have shifted our portfolio already into mid single digit or above market environments and our weighted average market growth rates have already increased from 50 basis points. And this happened through thoughtful resource allocation and some of the active portfolio management we’ve done. Again, we’re going to be bolder, but the journey has already started. I’m excited about what we can and we’ll do across these three priorities. It’s about first and foremost people, human capital, having a best-in-class culture. Secondly, it’s about delivering operational excellence as a company mindset or mandate. And thirdly, it’s about making sure that we diversify and innovate in a far bolder way through organic and inorganic means. Those are my three priorities. So now that you got a better sense of all priorities. I want to talk about Q3. And again, I want to reiterate that we’re really excited about the performance that was on the quarter. Performance, that that was driven by continued execution, especially in the key areas where we’ve been investing. In particular, I want to talk about niche. It was a great quarter for niche, where we delivered a both market performance in key markets around the world. We also grew in areas that are mission critical within set upper extremities, CMFT, as well as sports medicine. We had solid performance in the ASC environment and we saw revenue generation coming strongly from our data technology and solutions platform, primarily within ROSA and Mobility. In knees, Persona OsseoTi are highly differentiated cementless platform continues to perform above our expectations. I was recently in Dallas at the hip and knee society, and the feedback continues to be superb. Can’t wait until we continue to bring this technology to other geographies. ROSA had a strong quarter continue to see great adoption. We’ve seen a lot of gross adoption happening in the ASC setting, where speed, we’re dealing with higher volumes that matter. In the ASC, we continue to see growth in the teams, and we’re executing contracts daily or portfolio second to none, and we’re benefiting from the recent acquisitions we done such as Embody and ReLign, against the backdrop of this strong execution, Medtech sector stocks have been facing pressure related to GLP-1 drugs and the impact or the perceived impact on obesity. This from a long-term perspective. With a mission-centric patient in the board organization, so if this drug class truly does accelerate and improves patient health, and if these drugs truly do become the end of the obesity pandemic around the world that is great news for everyone as long as truly this is sustainable in the long-term.
528 million [ph]:
Obesity is certainly an accelerator of the disease and certainly is an element of the disease or a driver of the disease. But let’s not forget that once the cartilage is damaged, there is no recovery. Once you get osteoarthritis, you will not get rid of osteoarthritis. And dropping weight is not going to cure osteoarthritis. Again, this is a degenerative and non-curable disease that we’re talking about. If anything, obesity is a blocker today to joint surgery as many surgeons are uncomfortable operating on patients with a BMI greater than 40% countries or even above the 30 thresholds in some locations. So why could GLP-1s then be a tailwind for orthopedics? Three compelling reasons. First, if you can lower the patient’s BMI below a certain threshold, 40 or 30 in some cases these patients now become eligible for surgery. And all the data points that we’re getting in primary markets like the U.S. is that there is a large percentage of patients who today are not going through surgery because their BMI is too high. Secondly, if a patient does lose their weight, and I would say, this is pretty logical and they do become more active, there will be a greater risk for additional joint procedures because there will be injury. And third, if a patient loses weight, they are likely to live longer, again, expanding the patient final for an orthopedic procedure. A good example of this fact is Japan, the second largest market in the world for osteoarthritis with minimal obesity rates, but very long life expectancy dynamics. We’ve not seen any near-term impact from GLP-1s, and we’ve seen the long-term impact would be a positive one for orthopedics and Zimmer Biomet. We’ve engaged independent third parties to perform surgeon surveys and have gathered U.S. based claims data. What still is early in the process, we are very excited about the initial findings. We look forward to sharing them. So in an nutshell, more of a tail win. We’ll be sharing data very soon. And We think that the logic will prevail, and this will be the end of what has been so far a rather emotional argument that is not being fact-based. In closing, I hope you can tell that I’m very confident about the future of this organization. I’m very excited to be here. Our end markets have never been stronger. I will believe that this market beyond the backlog is sustainable. Our execution is strong and is also sustainable. We’ve been delivering consistently for a while. And we’ll continue to do so with even greater focus and speed. We know what we need to do. The strategy is clear and we will execute on the strategy. We have financial flexibility to invest in higher growth markets, and we are going to continue to shift our portfolio mix and diversify our business. I generally believe this is the time for Zimmer Biomet. I’m proud of the work we’ve done and even more proud of the work that we’re going to be doing ahead. This is why I’m excited to be the CEO and even more excited to be proud Zimmer Biomet shareholder as I believe that now is the time for real value creation. With that, I’ll turn the call over to Suky for a run through of our Q3 financials. Suky?
Suky Upadhyay:
Thanks and good morning. I’d like to start my prepared remarks today by welcoming Ivan to his first earnings call as a Zimmer Biomet’s CEO. Ivan has been a constant force and a driver within the organization for several years. And I’m proud to work with him, and I’m excited by the partnership. As Ivan noted, we had another strong quarter driven by healthy and improving end markets and continued strong execution across the organization. Overall, we remain on track to deliver mid-single digit, constant currency revenue growth, and adjusted operating margin expansion in the back half of the year, just as we committed to on our second quarter call. Moving to results. Unless otherwise noted, my statements will be about the third quarter and how it compares to the same period in 2022. And my commentary will be on a constant currency and adjusted operating basis. Net sales were $1.754 billion, an increase of 5% on a reported basis, and an increase of 4.7% excluding the impact of foreign currency. Additionally, we had a selling day headwind of about 150 basis points that impacted all regions and product categories at about the same level. Excluding the selling day impact, consolidated ex-FX sales would have grown just over 6%. U.S. growth was 6%, and international growth was 2.9%. In the U.S., our strong year-over-year results were driven by recon and a step up in our S.E.T. category in tandem with strong capital sales. Outside of the U.S., we saw more moderated growth across Europe and Asia driven by tough comps and geopolitical headwinds, which I’ll discuss in our product category section. Global knees grew 7.3% with the U.S. growing 6.1% and international growing 9.1%. The strong performance in knees was driven by continued uptake from our Persona product portfolio combined with the benefits of our ROSA robotics platform. Global hips declined by 60 basis points with the U.S. growing 3% and international declining by 4.2%. Tough comps in China and headwinds in Russia disproportionately impacted our OUS hip business. Excluding these impacts, our international hip business grew in the low single digits. Looking ahead, portfolio expansion will continue to support growth in our hips business. Next, the S.E.T. category grew 2.8%. Again, as a reminder, there was about 150 basis points selling day headwind across all categories and regions. Our key focus areas within S.E.T., including sports, upper extremities, and CMFT continue to post double-digit growth, which was partially offset by other subsegments within the category. We remain confident that S.E.T. will grow in the mid-single digits in the fourth quarter. Finally, our other category grew 16.4% driven by ROSA sales. Now moving on to the P&L. In Q3, we reported GAAP diluted earnings per share of $0.77 compared to GAAP diluted earnings per share of $0.92 in the prior year. While we had higher year-over-year revenue and higher pre-tax operating profits, post-tax income was lower due to a favorable tax settlement in 2022 that did not repeat this year. On an adjusted basis, we reported diluted earnings per share of a $1.65, compared to adjusted diluted earnings per share of a $1.58 in the prior year. The step up is primarily driven by revenue growth in the quarter, partially offset by higher operating expenses and higher interest costs. Our adjusted gross margin was 70.9%, up 20 basis points from the prior year, primarily driven by favorable mix. Adjusted operating margin was 26.4% and up slightly versus the prior year. Better gross margin and savings from efficiencies across SG&A were partially offset by higher R&D expenses that will support upcoming product launches ultimately driving a continued increase in our vitality index. Net interest and other adjusted non-operating expenses of $48 million was higher than the prior year due to certain foreign currency exposures as well as higher interest rates. And our adjusted tax rate was 16.7% in the quarter. Turning to cash and liquidity, we had operating cash flows of $338 million and free cash flow of $189 million in the quarter. We ended with cash and cash equivalents totaling just under $300 million. Our balance sheet remains strong providing us financial flexibility and strategic optionality as we move forward. Now, regarding our outlook. Overall for 2023, the outlook remains largely unchanged from the prior quarter, implying over 7% constant currency revenue growth and 9% EPS growth at the mid points of our range. We expect reported growth for the full year to be 6% to 6.5% and are maintaining our ex-FX growth expectations for the year of 7% to 7.5%. Inside of that, the U.S. dollar has strengthened. So we are increasing our outlook for foreign currency to be about a 100 basis point headwind to revenue growth for the full year. Additionally, we are reiterating our EPS guidance of $7.47 to $7.57 for the full year. Despite the strengthening dollar, which we project to be about a $0.04 headwind to fourth quarter earnings. This guidance implies that we will increase full year operating margins by about a 100 basis points in the backdrop of a challenging environment. In addition to our formal guidance ranges, I will reiterate that there is no material impact from selling days on the full year revenue growth expectations. However, we do expect about a 100 basis point tailwind in the fourth quarter. Additionally, our expectations for interest and other non-operating expenses as well as tax rate and shares outstanding remain unchanged. We expect free cash flow for the year to be between $950 million and $1 billion. In summary, we delivered another excellent quarter on both the top and bottom lines. We remain confident in our 2023 expectations and are excited about the next year with revenue growing in the mid-single digits and earnings growing faster than the top line. With that, I’ll turn the call back over to Keri.
Keri Mattox:
Thanks, Suky. Before we start the Q&A session, just a quick reminder to please limit yourself to a single question and one brief follow-up, so that we can get through as many questions as possible during the call. With that operator, may we have the first question please?
Operator:
Thank you. We’ll go first to Robbie Marcus with JPMorgan.
Robbie Marcus:
Oh, great. Thanks for taking the questions. I’ll ask both upfront as they’re kind of interrelated. Ivan and Suky, I was hoping you could address just the health of the ortho market. You talked to it, but we see your results and we see your peer results, and most of them were in line to slightly below in the quarter. So one, how you’re thinking about the health of the market? And then second, you touched last quarter and then this quarter as well on longer range guidance for 2024. You talked newer guidance this time about 100 basis points to 200 basis points above your end market growth. I think last quarter it was implying something like 4% plus. Is that a change? And how do we think about margins for next year? I think previously it was slightly up. Thanks a lot.
Ivan Tornos:
Hey, thank you, Robbie. I’ll start, I’ll talk about the market dynamics and briefly I’ll comment on 2024. I’ll pass it on to Suky to provide more color on 2024 and maybe discuss what he can discuss at this point when it comes to the margin profile. But I’ll start with the market dynamics. We’re the fourth company to report in Q3. So by now everybody sees that the markets are healthy. And quite frankly, I won’t talk much about Q4, but so far so good. So this is not a one quarter type of market dynamic. The reasons behind the market profile, the market growth profile and why I continue to say this market is different than four or five years ago is the things that I alluded to in my prepared remarks. The explosion of ASCs, the movement, the shift to ASC is real. That means new ASCs are opening in the U.S. That means [indiscernible] surgery are happening. Demographics around the world play a factor. We continue to track data in terms of the age for someone to get a hip or a knee. And these are younger patients. In the U.S., we would also see more days of surgery. And I don’t think this is just a backlog dynamic pricing, you see what every single one of us is reporting these days. It’s not the same pricing dynamic that we’ve had in the past. And beyond that, the technology. We are driving disruptive innovation. We got more efficient solutions, surgeries are shorter, and the episode occurred is shorter. So we are dealing with the patients, the fellow patients with more efficiency. Again, this is a durable trend. It’s happening in Q3. As I think about Q4, nothing is really changing. As we look into 2024, every early indicator suggests that things are not going to change. And relative to performance, well, look in the background of these healthy market dynamics in the U.S., we gain share in Q3 in both categories. Really proud of being number one in knees for the quarter. We don’t pay a lot of attention to any given quarter, but that is a fact that we’re the fastest growing company in the quarter. And then globally net of a couple of one-timers both in Russia and China. When it comes to hips, our performance was in line with hips and knees was very strong. And then as we get to 2024, I’ll let Suky comment, but we will be mid-single digit. That’s the point of entry. And nothing has really changed. It’s just getting closer to the end of the year and realizing that these market trends are sustainable. And the innovation pipeline that we have will drive the type of growth. But I’ll pass it on to Suky to comment on all the drivers.
Suky Upadhyay:
Yes. Hey, Robbie. Good morning. Thanks for the question. First thing I’d say is starting with the back half of this year, we committed to mid-single digit ex-FX growth for the second half of the year with operating margin expansion both sequentially and year-over-year. Q3 was a really another strong validation proof point of that. And we feel confident in that profile. The reason I mention that is I think it gives us a running start as we go into 2024. And so, I do want to talk a little bit about 2024 back to your question. First, we’ve already provided a lot of color, I think, on 2024 more than most of our peers. But we feel that being transparent, giving you guys a robust view of what we’re going to do, not only this year, but into the future is really important. But let me talk a little bit about the headwinds and tailwinds as we see it going into 2024 and some things have modestly changed. First, I’ll start with the headwinds. One, we do see a higher tax rate into next year because of the OECD’s Pillar Two. Secondly, based on where FX rates are today, we’d see some additional pressure from a foreign currency perspective into next year. Again, both of these are more macro versus execution, right? They’re things that are outside of our control, but we’re going to contend with them and we’re going to deal with them. And I’ll tell you a little bit about how. On the tailwind side, I would say, yes, we are more confident in our outlook for revenue next year. Our end markets are stronger than they’ve ever been. Our portfolio and new product launches have been executing extremely well in some areas above our expectation. Our performance relative to market has been very strong, and that’s consistent and durable. And quite frankly, we’re seeing a more moderated pricing environment still erosion, but much more moderated than what we’ve see in historically. All of those elements give us confidence that we’re going to be able to post a mid-single digit growth top line ex-FX into 2024. And then, despite those sort of P&L headwinds I talked about, we do believe that we’re going to be able to grow earnings faster than revenue. I talked about gross margin next year, stepping down because of the FX hedge gains from this year, not repeating at the same level. That will still happen, but we’re going to be able to offset some of that. The operations and manufacturing team has been working really hard at efficiency. And so we feel more optimistic about where gross margin is going into next year. Secondly, as I said, we’ve already got a running start on a lot of SG&A efficiency programs in the back half of this year that are going to run into next year. So when you combine those two elements together again, we feel really confident that we’re going to be able to do that mid-single digit top line growth next year, as well as earnings growing faster than revenue. So, thanks again, Robbie, for the question.
Robbie Marcus:
Appreciate the color. Thanks a lot.
Keri Mattox:
Thanks, Robbie.
Operator:
Thank you. We’ll go next to Drew Ranieri…
Keri Mattox:
Thanks, Robbie.
Operator:
…with Morgan Stanley.
Drew Ranieri:
Hi Ivan and Suky. Thanks for taking the questions. Just maybe on 2024 also you haven’t talked about backlog much recent conferences. You kind of pointed out that you think it’s going to carry through 2024, but just maybe help us a bit more of how you’re factoring that into your mid-single digit directional guide for next year? I know it’s not, I know your growth is not all dependent on backlog but just how do you think about that helping to support the orthopedic market growth? And maybe just talk to us about your ability to capture a disproportional amount of share of that backlog? Thank you.
Ivan Tornos:
Yes, Drew, thank you very much. And first things first, you should be in your honeymoon considering that you got married recently. So I’m disappointed you here. Look, I’m going to keep this short and sweet. We don’t see backlog as a major driver, growth profile for the next year. So when Suky and I said on mid-single digit, we’re not assuming any real meaningful backlog. So not a key driver. We believe and we spend a lot of time going back and forth on backlog that is going to remain here throughout the end of 2024 at least. But we are not a backlog depending – backlog dependent type of a company. So we don’t have – we don’t focus on that. What we’re tracking is innovation, the pipeline that we have, but we’re tracking is the investments we made in the ASC we’re tracking is commercial execution and in the background, just sustainable pricing dynamics. So no backlog. Thank you.
Drew Ranieri:
Thanks. And just a second as a follow-up. Your commentary was very strong that you’re expecting mid-single digit S.E.T. growth into next year. But just remind us about what’s it going to take to really accelerate S.E.T.? And maybe just talk a little bit more about the lift on the organic side and maybe what you’re thinking about in terms of M&A to get that growth rate higher and more sustainable? Thanks for taking the questions.
Ivan Tornos:
Yes, absolutely. Great question. First things first. Q3 S.E.T. was in line. As we move into Q4, we’re actually going to be a mid-single digit grower. I’m not going to talk about S.E.T dynamics for 2024. We’ll do that coming guidance, but very excited in terms of where we are. We integrated a couple of companies we have seen SportsMed. Those are performing very well. Our upper extremities, our shoulder business is growing in the mid to upper single digits in most regions. When you look at our CMFT, craniomaxillofacial thoracic, which is part of S.E.T. It has been performing very well. It continues to perform very well. So, again, lots of reasons to believe that as we getting 2024, you should expect a sustainable performance in S.E.T. In terms of M&A, again, we’re coming more on that later, but it remains the number one recipient of capital allocation. We haven’t changed in that regard. And yet, S.E.T. is one category that is very attractive, given the higher market growth dynamics or position in the space. So you should assume that this is one area where we’re going to be focusing from an M&A standpoint. But again, native M&A already delivering mid-single digit growth entering Q4 strongly, and we are excited about 2024. Thank you.
Keri Mattox:
Thanks, Drew. Katie, can we go to the next question in the queue, please?
Operator:
We’ll go next to Matt Taylor with Jefferies.
Matt Taylor:
Hey, thanks for taking the question. Congrats on a good quarter. I was curious about your outlook comments for 2024. And I was hoping you could specifically address the concern I think investors have about growth, especially in the first half of the year with, I’ll do air quotes on this, but tough comps especially in Q1. So maybe you could address how you think you can grow throughout the year and address investor concerns about those tough comps in the first half?
Ivan Tornos:
Yes, I’ll start Matt, and again, Suky maybe want to chime in here. But we confident about 2024 because the market dynamics are sustainable. So there has been a lot of back and forth in terms of what’s going to happen once the backlog is out and all that. First, the backlog. We don’t think it’s going to be out anytime soon. And then pricing is sustainable. And all the things that I mentioned, excuse me, my answer to Robbie, are here. They move to the ASC the shorter episodes of care more days of surgery. So macro wise every data point we get in that is very compelling. And then on the micro, we are seeing a bolus of innovation being launched. We got 40 new products that we’re going to be launching over the next 36 months. Some of these products are very compelling. We launched our Persona OsseoTi, which is the cementless construct earlier in 2023. That is going to be a full – truly full market release in the U.S. in 2024 with the right amount of S.E.T.s and that’s high growth. As we enter the first semester of 2024 to your point, is another two or three very meaningful product launches. Some in robotics, some within recon, some in S.E.T., that’s very compelling. The integration of embodying, the integration of relying continues to generate revenue. I could spend an hour, but I will tell you that is the balance of really sustainable micro dynamics and solid innovation. And then on top of that, you got great commercial execution with a highly engaged sales force. So I’m not – we are not deeply concerned about the about the comps.
Suky Upadhyay:
Yes. I think just building on that, remember the first half of this year, which was very strong, was more about comps versus 2021, or excuse me, versus 2022. Then it was something about abnormal market growth. So again, just building off what Ivan said, we feel confident in that. Now we’re not of course giving specific guidance, and we’re certainly not giving quarterly guidance into next year. So, as always quarters can be choppy or driven by seasonality mix changes, but overall, we’re confident that the single vision.
Ivan Tornos:
And maybe one last comment here, Matt, quickly we can move on. Don’t forget that the first semester of 2023, while it had very solid comps, also had pretty challenging dynamics from a supply standpoint. So as we think about 2024, that we believe it’s going to be a tailwind.
Matt Taylor:
Great. Thanks, guys. We’ll leave it there. Thank you.
Suky Upadhyay:
Thank you.
Keri Mattox:
Thanks, Matt.
Operator:
We’ll go next to Shagun Singh with RBC Capital Markets.
Shagun Singh:
Thank you so much. I’m just going to try to ask the Q4 implied in 2024 guide in a different way. Your Q4 implied guidance assumes a deceleration from Q3. And your commentary seems pretty positive. It implies a deceleration even on a stack two-year basis, which are just for comp. So should we just assume that it’s conservatism? And then if you look at growth on an underlying basis, adjusted for China, VBP selling days and all one-time items, I think you did plus 6% in 2022. You’re looking to do 7% to 7.5% in 2023 guidance. Sorry, consensus is looking for about 4.5% growth in 2024. I know Ivan, one of your targets is to drive that revenue growth acceleration. You’ve indicated that you will not be satisfied with 4% to 5% growth for the company. So just what is your reaction to that 4.5%? Does it look conservative to you in the context of the comments that you made?
Suky Upadhyay:
Sure. Hey Shagun, this is Suky. Thanks for the question. So just first some fourth quarter, I’ll just keep going back to – we don’t give quarterly guidance and obviously with our implied, you can pretty much squeeze into the last quarter of the year. We talked about mid-single digit growth margins expanding in the back half of this year, and we’re going to deliver on that. We have a range around our guidance. Obviously, the – to the downside, geopolitical factors continue to be erosive or supply doesn’t continue to, that very positive trend has been on. Then you’re towards the bottom end. However, if that supply picks up and it remediates even faster than it’s already been improving, then as well as better execution on our new products, we could be at the upper end. So there’s a range around that and so I’ll just leave it at that. But overall, we feel really good about where we’re ending the second half of this year and where our end markets are. As we look into next year, I think you’ve seen a bit of a pivot where our commentary was before anchoring towards 4%, maybe even better to now where we’re saying mid-single digit. And I think that reflects the momentum that we’ve seen to your point in 2022 and 2023.
Shagun Singh:
Got it. And if I could just ask a question on M&A.
Ivan Tornos:
Yes, go ahead. Go ahead, Shagun.
Shagun Singh:
Okay. Great. Just on M&A, Ivan, if you could just elaborate a little bit more in your thinking of tuck-ins versus larger deals, high growth adjacencies that may allow you to diversify outside of elective procedures. And then I’m most interested about ASCs, a lot of your businesses moving to ASC that is a growth driver. What do you need to further succeed there? Do you need a broader bag or more depth? Thank you for taking the questions.
Ivan Tornos:
Yes, absolutely. So on M&A, as already mentioned, and it was in my prepared remarks as well, it will remain our top strategic priority from a capital allocation standpoint. So that’s not changing. And we’re excited about the opportunities that we have in front of us. We’re going to continue to focus on growth markets or areas that are not only mission-centric, but offer an exciting growth profile. And that is three things. No ranking order. Three key areas, segments within recon that are growing faster than [indiscernible] or collected or collective market growth rates. And there’s a lot in there. You got navigation. You got data, technology, elements of recon that are really attractive. Two is set as we’ve done already. Buying things in sports med, buying things in CMFT, and then looking at other categories that I don’t want to get into for our competitive dynamics. But again, optionality there. And then ASC is also one attractive area, is one area where we have dedicated resources, we growing in the teams. We have currently 10% to 15% of our sales in that space. And there is opportunities there to acquire things. So that’s a bit of the strategic summary of where we go from an M&A perspective. In terms of financials, we’re not changing the story. We like to do things up to $2 billion in acquisition price. And again, that gives you a lot of options. You can do a mid-size deal. You can do some tuck-ins combination of different things. We want these deals to be EPS neutral within two years. And we spoke about high-single digit ROIC within five years. So that’s a bit of a strategic and financial profile. As we look into the next three or five years, we spend a lot of time, Suky and I have spent a lot of time looking at the strap plan. What is the growth profile? The great news is that we convinced that the free cash flow generation is solid. So we’re going to be able to do M&A and potentially do other stuff when it comes to capital allocation. So that’s the answer to your first question. On ASC, look, I don’t think we need to do much more. We growing in the strong things already here in the U.S. in the ASC. I mentioned 10% to 15% of our sales are there. We got the right portfolio. This is now where we were let’s say three, four years ago. We got the right robotic platform for the ASC. We got a great cementless Knee that is gaining there very quickly. We got a full bag in sports and across set. We got best-in-class technology so the portfolio is great. We got dedicated resources, which you very much need in an ASC environment. We have a dedicated sales force. We got simple contracting, simplified contracting, and look what we don’t have organically, we partner with others. So whether it’s sterilization, booms and lights or other stuff, we got the right partnerships. So very, very confident that we’re going to continue to perform in the ASC environment. Thank you.
Keri Mattox:
Thanks so much, Shagun. Katie, can we go to the next question in the queue?
Operator:
We’ll go next to Josh Jennings with TD Cowen.
Josh Jennings:
Good morning. Thanks, Ivan, Suky, and Keri. Wanted to just follow-up on your ASC comments. Ivan, wanted to ask about the migration of total joint surgeries to ASCs. Any back the envelope assumptions you would have as used just in terms of where the penetration or where the migration for knees and hips has been. What percentage of cases for each categories reported in ASCs currently here at the end of 2023 versus 2022. And then any metrics you can share just with roads of penetration and ASCs, and then any pricing dynamics for total joints as this migration is occurring. Thanks, multi-part question, but I appreciate you taking it.
Ivan Tornos:
All right. Let’s see if my memory is as good as I think it is. So starting with ASC macro wise, we believe that roughly between 40% to 60% of cases in the next five years are going to move to the ASC. And I will say that a large portion of cases are already moving to the ASC. What we like about this dynamic is that as cases are moving to the ASC, other cases are going to in-patient and outpatients. So it’s a little bit of a double dip happening their just, but yes, the number is 40% to 60% over the next three to five years. And I would say a good percentage has already moved. We are growing in the upper teens when it comes to the ASC and today around 10% to 15% repeating myself of cases or revenue rather of Zimmer Biomet comes from the ASC. I will tell you that it’s pretty equal in terms of both hips and knees. So we don’t see one category being above the other. And I like the fact that given the recent CMS changes, you’re going to see sold their cases also accelerating the ASC. We believe that’s a great opportunity for us here at Zimmer Biomet. So that’s the answer on ASC. In terms of ROSA dynamics I think we’ve been very transparent in terms of one-third, roughly one-third of all of our installations are happening in the ASC. That’s a trend that has been happening for a few quarters, and that’s a trend that we continue to see happen in the next quarters. In an ASC environment speed matters, not having to get engaged in complex pre-planning matters. Efficiency does matter and having a knee that you are confident it’s going to be the right knee that matter. And those dynamics are driving ROSA penetration in the ASC. And then outside of the ASC, ROSA continues to perform. We are selling and placing ROSA’s frankly at a rapid pace. You see in the other category, we saw nice increase that’s driven by ROSA. And we are on track to at least install 300 units at the end of the year 2023 when it comes to ROSA, so really satisfied. And that’s before we launch next generation ROSA across recon and deliver the first shoulder robotic platform. So excited about both ASC and ROSA. Thank you for the question, Josh.
Keri Mattox:
Thanks, Josh. Katie, can we go to the next question in the queue?
Operator:
We’ll go next to Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
Good morning. Thanks for taking the question. And Ivan, I have enjoyed watching your posts on LinkedIn. You looks like you’ve traveled around the world literally since you’ve taken over as CEO. I wanted to ask so if you start on the margins, you’re going to end 2023 with an operating margin about 28.5% which is towards the high end of med-tech. Where – what do you see as peak margins for Zimmer? I mean, 5, 10 years ago the margins were in the low-thirties. Is that still realistic? And I had one follow-up.
Ivan Tornos:
Yes. Sure. So good morning, Larry. Thanks for noticing. It’s actually two years in a row where we’ve expanded margins in the backdrop of really challenging environment, by the way, while also accelerating revenue. I think in 2022, we expanded margins, operating margins by about 40 to 50 bps. And this year, you’re right, the implied is about 100 basis points. So again, really proud of what the ZB team has done collectively, again, in the backdrop of still investing for growth, which we’ve been able to demonstrate. As we move into next year, I think I’ve been pretty front footed in our ability to continue to grow margins in 2024. And quite frankly, we’re going to do that in every year after 2024 and continue to deliver a profile where earnings are growing faster than revenue. I’m not going to go out and put a marker out there as to where we think it can get to, but historical levels we will look for over time to definitely hate and exceed those. So I’ll just leave it there. Again, really happy with where the team’s performed over the last couple of years. Very confident what we’re going to do next year. Quite excited about our outlook in the longer-term.
Larry Biegelsen:
That’s helpful. And then the follow-up…
Ivan Tornos:
You had a follow-up, Larry?
Larry Biegelsen:
Yes. Other – the other category was obviously very strong. We heard you talk about gross of sales in the quarter. What was the change in the quarter that drove that strength and how sustainable is that? Thanks for taking the questions.
Ivan Tornos:
Yes. I don’t think there is anything changing really. There’s not a change of strategy is we continue with ROSA. We continue to show strong clinical efficacy. We continue to demonstrate time neutrality after a few cases. We continue to see great adoption in an AC environment. We have three ROSA indications today within recon. So total knee partial and hip, we’ve done a lot of podium presence. If you attended the Dallas meeting this last weekend. There was a lot of noise around posters and whatnot. So I think we just get in the right adoption is moving quickly. And then a driver, I will tell you has been tremendous. A lot of these cases that are done, the ASC do like or do one, a lot of surgeons in an ASC won the combination of robotics and cementless. In the past, we didn’t have the right cementless construct. We do not with Persona OsseoTi. So I think that’s been a bit of a tailwind, but I wouldn’t say it’s a major change of the strategy is just the fact that it’s been two, three years in market now and you’re starting to see the data. So really excited in terms of what we are.
Larry Biegelsen:
Alright, thank you.
Suky Upadhyay:
Hey, Larry, just to get back to your original question, just to make sure I’m completely clear. I do see getting back to historic margins are better over time. Absolutely, a definable objective for us, now having greater insight and taking over for option supply chain, I would say, this is an area where we can certainly do better. We’re going to do better going forward. And I can tell you that the company’s focus on not just revenue growth, but operating profit and free cash flow generation has been more acute and stronger than it’s ever been. So I think we’ve got the pathway, we’ve got the culture, we’ve got the levers to get there over time. Thank you.
Larry Biegelsen:
And Larry, yes, thank you for being my one follower on LinkedIn, the whole time, I said it was my wife. I’m disappointed. Appreciate it.
Keri Mattox:
Thanks, Larry. Katie, can we go to the next question in the queue?
Operator:
Thank you. We’ll go next to Chris Pasquale with Nephron.
Chris Pasquale:
Thanks. Just want to follow up real quickly on Larry’s ROSA question. Was the mix of sales versus placements different in 3Q than what we saw in the first half of the year? Just trying to figure out whether that played a role or the acceleration in other sales was really driven by system volume.
Ivan Tornos:
Yes. Thank you Chris, for the follow-up. We did see more sales. We haven’t changed the strategy, so it’s reflective of the fact that there is capital in the hospital systems across the world. And we saw people wanting to buy them and we sold the units. It’s not a fundamental change, it’s not a change in the strategy. We settled along that we prefer placing, given the annuity factor and whatnot. But yes, capital is strong and we did do some deals in some ASCs and in some of the systems and that’s why you see the other category growing. Thank you, Chris.
Chris Pasquale:
Thanks. That’s helpful. And then on SET, is the strategy there to lean into these focus categories that are already growing pretty well and then hope that the overall performance improves as they become a bigger part of the mix? Or do you see an opportunity to reinvigorate areas like lower extremities that maybe aren’t on that list today?
Ivan Tornos:
Yes. Let me start with the second part. We really don’t do hope here. So we do have plans to drive better performance in the three areas that so far have not been that compelling, those being restorative therapies for an ankle and trauma. What I will tell you is that the restorative therapies, biologics, the issue, there was a reimbursement change a year ago that’s been resolved. So that’s not a concern moving forward. And then foot and ankle, lower extremities is something that we’re looking at. It may require it some organic inorganic place, but given the space we paying close attention to what is that we need to do. And then trauma for many markets continues to be very attractive. We done some smaller tuck-ins, so I would expect that the declines that we have seen in the past are going to disappear. So again, not really doing hope there. We got plans to remediate and to get back to growth in those three categories. Now that said, the three most compelling priorities within set remain upper extremities shoulder, sports, medicine, and CMFT and those three are performing very nicely.
Chris Pasquale:
Great. Thank you.
Ivan Tornos:
Thank you.
Keri Mattox:
Thanks, Chris. Katie, can we go to the next question in the queue?
Operator:
We’ll go next to Travis Steed with Bank of America.
Travis Steed:
Hey, thanks for taking the question. I guess, a quick follow-up on M&A, any way to frame how much margin or EPS solution you’re willing to take in yours one and two, realize you said neutral by year three. But curious kind of what the framework is on year one and two. And when you think about bid ask spreads, is a deal something you think you could get done this year or is it probably more something for 2024?
Suky Upadhyay:
Hey, Travis. This is Suky? I’m not sure I completely got that second question. Can you repeat that?
Travis Steed:
Yes. In terms of like, when you think about like bid ask spreads and the progress on your conversations, is a deal happening in 2023 a possibility or is it probably something that we need to like the 2024 to see M&A?
Suky Upadhyay:
Yes. So first of all, on your first question around earnings per share dilution, that’s really going to depend on the type of asset that we acquire, the size of the transaction, what market’s in, where it is in its journey and its life cycle is a product that’s just launched or something that’s very mature in marketplace. So I’m not going to sort of give a guidepost on year one or year two, because I think that would be premature because it is going to be very situation dependent. But what we will commit to is that we’re going to look for break even by at least 20, 24 months, if not sooner than that, so that’s the profile that we look for in our M&A. Now relative to bid ask and timing of course for a variety of reasons mostly proprietary. We’re not going to get into the timing of any specific deal as you know, those are often opportunistic situation based. So here’s what I would say is that we’ve got a lot of strategic flexibility to balance sheets in the strongest position, it’s been since the merger of Zimmer Biomet. We feel really good about the optionality we have going forward and we think we can deploy capital to continue to accelerate our growth profile and diversify the company. But I’m not going to get any specific timing. I’m sure you can appreciate that, but thank you for the question.
Travis Steed:
Yes. That’s fair. Thank you. Thanks for the answer. And a couple housekeeping questions. The OUS, one time stuff in hips this quarter, does that get better in Q4? And when you think about tax rate next year, I heard your comments, but curious if that’d be like on a less than a 100 basis points or more than a 100 basis points on tax rate. And when you think about the interest line, you’ve got I think $850 million in debt coming due. So is interest a headwind or tell in next year?
Ivan Tornos:
All right. I’ll briefly comment in on Q4. I’ll keep it simple. It does go away. So this is the one-timer and in Q4 we get back to growth. In terms of the tax and interest, Suky, do you want to comment on that?
Suky Upadhyay:
Yes. So on the expense line, right now we’re not going to give full guidance on that. So we’ll unveil that. I think the one thing you want to keep in the backdrop is we do believe we can grow earnings, we will grow earnings faster than revenue. On the tax rate, right now our best estimate is that it’ll be about 150 basis point increase off of our full year 2023 tax rate.
Travis Steed:
Thank you. Thanks a lot.
Keri Mattox:
Thanks, Travis. I think we have time for maybe one last question. Katie, is there one in the queue?
Operator:
We’ll go next to Vijay Kumar with Evercore ISI.
Vijay Kumar:
Hey, guys, thanks for squeezing me in here. Maybe just one question from me. This OUS hips, I think you called up Russia headwinds. Is that done with in fiscal 2023? Should that continue in the fiscal 2024? And I think you did speak about M&A. Can you comment on your hurdle rates you given current interest rate in monument for deals?
Ivan Tornos:
Yes. Sure. Hey Vijay, it’s good to hear from you. So on the OUS hip headwind, specifically due to Russia, if you go back the last quarter’s call – second quarter, I talked about Russia being about a 50 basis point headwind in the back half of 2023. That estimate is still largely true and most of that occurred in the third quarter. So we’re going to see a little bit of pressure in the fourth quarter, but it’s largely behind us. We don’t see that as being a headwind at this time into 2024. And I’m sorry, Vijay, could you repeat your question around.
Vijay Kumar:
Sorry. On the deal M&A given current interest rate environment, can you talk with your herded rates for you know, deals?
Ivan Tornos:
Yes. So look we would still look at debt financing over equity financing all day long. Even though, it’s 2x of where it was a year ago, it’s still versus historical rates still a pretty attractive source of capital. It has become marginally more difficult to make the deal economics work at, at these interest rates. So it just means that we’ve got to be that much more disciplined on our valuation and in our purchase price. And so that’s how we view things right now.
Operator:
Thanks, Vijay. And thanks everyone for the question. Yes, absolutely. I think now we’re probably nearing the end of the call. I’ll turn it back over to Ivan just for any closing remarks.
A - Ivan Tornos:
Yes, thank you Kerry. And I’ll keep it to two minutes or less here so we can close on time. But a couple of things here. Number one, really, really pleased with the progress here at Zimmer Biomet really proud of the team and the work that they have done they are doing, and most importantly, the work I know that we are going to continue to do excited about the markets, lots of questions on market dynamics. Every data points suggests that their healthy markets, their durable markets no. We’re not concerned about GLP-1s and I’ll say that with the utmost respect and humility, but every data point shows that this is not something we should be concerned about. The performance is strong and it’s going to continue to get there. We saw a great Q3 performance in recon net of the hip issue OUS. It was solid. I like where we are with both hips and knees here in the U.S. in the largest market. I like the fact that we’ve seen set being in line now. I like the profile as we enter Q4 and as we get into 2024. I believe this will be the year for set. And I like the optionality that we got around M&A. So healthy market, solid portfolio, great opportunity to leverage the balance sheet. I do think it’s a different place, a different environment. So really excited to be here. Look forward to leading this great team. I look forward to answering more questions in quarters to come. Thank you for your time today.
Keri Mattox:
Thanks everyone for joining us. The IR team will be in touch of course, and if you have questions or comments, please feel free to reach out. Thank you.
Operator:
Thank you again for participating in today’s conference call. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet Second Quarter 2023 Earnings Conference Call. [Operator Instructions]. I would now like to turn the conference over to Keri Mattox, Chief Communications and Administration Officer. Please go ahead.
Keri Mattox:
Thank you, operator, and good morning, everyone. Welcome to Zimmer Biomet's Second Quarter 2023 Earnings Conference Call. Joining me today are Bryan Hanson, our Chairman, President and CEO; and EVP and CFO, Suky Upadhyay; and COO, Ivan Tornos. Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by the forward-looking statements due to a variety of risks and uncertainties. Please note, we assume no obligation to update these forward-looking statements even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties and in addition to the inherent limitations of such forward-looking statements. Additionally, the discussions on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within our Q2 earnings release, which can be found on our website, zimmerbiomet.com. With that, I'll turn the call over to Bryan. Bryan?
Bryan Hanson:
All right. Thanks, Keri, and thanks to everyone for joining us on the call this morning. It's always good to be with you. But I would say it's even a little better and certainly more fun when we have great performance in the quarter. So we're pretty happy about the results that we get to discuss today, and I can tell you, we're looking forward to the dialogue. And I'll start things up, as we normally do, I'll talk about our Q2 performance and the key drivers inside of the quarter. But I think also really important is to talk about the key drivers that we see continuing to move this business forward. And then Suky will walk us through the financial details of the quarter and importantly, discuss how we are again raising our full year financial guidance. And then, of course, we'll close things out with a Q&A session, and we look forward to answering your questions and having a dialogue in that session. Okay. To kick things off, I'm just going to take a step back, which I've been doing now for the last handful of quarters and I think deservedly so, because I want to say thank you. I want to say thank you to each and every one of our team members around the world because it's your hard work, it's your dedication to getting the job done that is moving this business forward. And I will tell you that I'm proud to say that you have delivered another very strong quarter, while once again making ZB a certified Great Place to Work. And you've done all of this while improving our scores and as a result of that, our rankings on the environmental, social and governance front. So I think simply stated, we are doing well, while also doing good. And that means for our team members, our patients, our customers and our communities and even our planet. So once again, I want to say thank you to our team for all that you do for ZB and to move our mission forward. And most importantly, for doing it together as one team, one ZB team. Now let's talk about the second quarter. And I'm just going to say simply, we delivered another strong quarter, again beating our own expectations. And that performance positions us to again raise our financial guidance on both the top and bottom line. And this is in the face of some pretty significant macro factors that are impacting us in the entire market. Ongoing supply challenges are very real, and I'll talk about those in a minute, but also inflationary pressure, a tough labor market and the geopolitical landscape that is putting pressure on everybody. But against that, I feel very confident about our pipeline, our execution and the team's demonstrated ability to navigate these headwinds, which gives us confidence to increase our financial outlook. Okay. With that said, let's talk about the key drivers inside of Q2, and there were some positives and there were some negatives. I'll start with the positives, and the most important one, in my view, is that our team's execution remains flawless. We're seeing significant traction, probably the best we've ever seen with our new product innovation. And that paid dividends in the quarter for sure, but most importantly, is it pays dividends as we move this business forward. And I would say that procedure recovery continued in the quarter, again showing no meaningful impact from COVID or staffing challenges, and that allowed for a tailwind from increased provider capacity, and that resulted in backlog pull-through in the quarter. In terms of headwinds, I would say that the team is doing a great job of managing the supply-constrained environment. But I would say that it is still very clearly a governor to our overall growth in the quarter, and it continues to be a distraction for the organization. See if I combine these things, though, all in all, our momentum continues, and it continues to grow. And I've said before, my confidence in this business, our confidence in this business is as high as it's ever been. And it's high for a good reason. If you just look at the knee franchise alone, our innovation strategy is working. We now have 4 meaningful pillars inside of this business. All of which can drive pricing stability, mix benefit and competitive conversions. First, let's look at the ROSA Robotic Platform combined with our Persona cementless Knee. Now this is a powerhouse combination that is and will continue to accelerate growth. And based on the traction we're seeing so far, we continue to believe that ROSA and Persona cementless together will enhance our robotics and cementless penetration from the current mid-teen level to 50% or better, 5-0% or better. The second pillar that we're focused on is Persona revision. This provides a meaningful conversion and mix opportunities inside the revision category. But importantly, it also acts as a powerful tip-of-the-spear product for conversions and primary needs. And then third, it's just the overall shift of the ZB legacy knee systems to our now fully rounded out Persona portfolio. And this is a meaningful mix benefit that we can take advantage of that, I would say, is somewhat unique to our business. And then fourth, on top of all this, we have the world's first and only Smart Knee which is Persona iQ. And I know this is still in limited launch, but already, it offers surgeons unparalleled data access and is attractive to patients, those patients who want more direct engagement with their care recovery. And we're taking on a similar approach to our hip portfolio where we continue to launch meaningful innovation, again, giving us the opportunity for price stability, mix benefit and competitive conversions. And we have 4 pillars of focus here as well. First, it's ROSA and Hip Insight. These are technology shifts in robotics and mixed reality that are setting up the ZB Hip portfolio for greater adoption and growth. Second is the Avenir Complete. This is our current flagship product combined with G7, which gives us a very strong position in both the attractive direct anterior and revision submarkets of hip. And then third, this position will be enhanced with work being done on a triple taper stem which will fully round out our direct interior approach portfolio. We believe this new portfolio, combined with the G7, which is the most versatile acetabular component available will be unmatched in the industry. And then fourth, HAMR. This is our upcoming full launch of an automated impaction system that builds on a proven need in the market, and we fully expect that this launch will create surgical efficiencies while bringing personalized precision to each and every patient. And then finally, in S.E.T., we are being disciplined and targeting investment in our growth driver categories, Upper extremities, Sports and CMFT, and each of these categories continue to perform. And given our momentum in these businesses and continued investment in innovation and dedicated infrastructure, we fully expect the S.E.T. set business to be a mid-single-digit grower in a normalized market environment. So overall, we're very excited about our innovation momentum. It's very real. Remember, we've called out that we have 40 planned product launches between this year and the end of 2025. With the majority in 4%-plus growth markets. And that's important because these innovations will certainly drive near-term growth. There's no question about that, but also create better sustainability of that growth because of the markets they're in. This portfolio shift that we're seeing and the team's execution capabilities are clear signs that our ZB transformation has taken hold. But I can tell you right now that we're not going to stop there. The goal is to continue to enhance our growth profile through our ongoing focus on active portfolio management, and that is supported by our already strong and strengthening balance sheet. And with that, I'll turn the call over to Suky for a closer look at Q2 and our latest expectations for the remainder of 2023. Okay, Suky?
Suketu Upadhyay:
Thanks, and good morning, everyone. As Bryan noted, we had another excellent quarter. Our results were driven by strong end markets as well as strong execution across the entire organization. As a result, we are again increasing our full year financial outlook. With that, let's turn to our results and updated full year guidance. Unless otherwise noted, my statements will be about the second quarter and how it compares to the same period in 2022. And my commentary will be on a constant currency and adjusted operating basis. Net sales were $1.870 billion, an increase of 4.9% on a reported basis and an increase of 6%, excluding the impact of foreign currency. Additionally, we had a selling day headwind of less than 50 basis points in the quarter. Overall, the business continues to benefit from a recovery of elective procedures driven by continued market normalization, including hospital staffing and procedure cancellations returning to pre-COVID levels. We also benefited from some backlog recapture. While market momentum is strong, we continue to face certain macro challenges, including global supply chain pressures that muted performance across the business. U.S. growth of 5% continued to outpace our expectations and international growth of 7.2% was driven by strong performance in both EMEA as well as Asia Pacific. All regions benefited from continued recovery of elective procedures, backlog recapture as well as strong commercial execution and new product uptake. Turning to our business category performance. Global Knees grew 10.5% with U.S. growing 9.8% and international growing 11.4%. The strong performance in Knees was driven by the 4 pillars that Bryan mentioned earlier, centering on a very attractive Persona portfolio, combined with the benefits of our ROSA robotics platform. Global Hips grew 4.9% with U.S. Hips up 2.7% and international up 7.1%. Both regions posted good growth on the back of new product flow, execution and market recovery. Next, the S.E.T. category was down 30 basis points year-over-year. Inside of that, we saw continued strong performance from our 3 focus areas within the business segment. As expected, we saw pressure from reimbursement headwinds within the Restorative Therapies business. In addition, we experienced more acute supply challenges within Sports and Trauma. In the backdrop of this, we believe we will move beyond these headwinds, and this segment will rebound in the second half of the year. Finally, our Other category grew 6.5%. Now moving on to the P&L. In Q2, we reported GAAP diluted earnings per share of $1 compared to GAAP diluted earnings per share from continuing operations of $0.73 in the prior year. The increase was driven by higher revenues combined with lower nonoperating expenses due to ZimVie investment losses from the prior year that did not repeat as well as lower spend related to restructuring costs. These benefits were partially offset by increased investment in R&D and commercial initiatives to drive future growth. On an adjusted basis, we reported diluted earnings per share of $1.82 were flat to the prior year. Higher year-over-year revenues and better gross margins were offset by higher R&D expenses, increased investments into commercial infrastructure for new product launches and higher interest expense. Our adjusted gross margin was 72%, up 40 basis points from the prior year despite absorbing current year inflationary pressures as well as pressure from prior year that was capitalized and flowing into this year's P&L. Favorable mix and FX hedge gains also helped support the increase in gross margin. Adjusted operating margin for the second quarter was 27.5%, down 50 basis points from the prior year. While gross margin was up, this was offset by higher operating expenses due to increased investments in R&D, aligned to our plan to improve our vitality index through new product innovation as well as higher commercial infrastructure costs to support new product uptake. Net interest and other nonoperating expenses of $57 million was higher than our expectations and significantly higher than the prior year due to certain foreign currency losses in the quarter as well as higher interest rates. Our adjusted tax rate of 16.3% was in line with expectations. Turning to cash and liquidity. Operating cash flows were $348 million and free cash flow totaled $165 million. We ended the quarter with cash and cash equivalents of $320 million. Our balance sheet remains strong, providing strategic and financial flexibility for future growth. Moving to our updated financial outlook for 2023. Based on another strong quarter of results, we are again raising our full year 2023 outlook. We are confident that we will continue to grow our top line above market rates and expand operating margin while continuing to reinvest in our business for future growth. We are increasing and narrowing our constant currency revenue growth range to 7% to 7.5% with an expected foreign currency exchange headwind of 50 basis points. We are also increasing our adjusted EPS guidance range to $7.47 to $7.57. Additionally, due to certain FX-related pressures and higher interest rates, we now expect net interest and other nonoperating expenses to be around $200 million for the year. Our expectation around tax rate and total shares outstanding remains unchanged. And we continue to expect free cash flow to be in the range of $1 billion to $1.1 billion. Our Q3 and Q4 revenue cadence expectations are unchanged. Q3 revenue dollars are expected to be sequentially down versus Q2 and in line with normal seasonality, and Q4 will be our strongest quarter on a dollar basis. While we expect momentum gained from the first half to flow into the second half of the year, recent and new sanctions on Russia may mute growth. And regarding selling day impact, we continue to expect Q3 to have a selling day headwind of about 150 basis points, while Q4 will have about 100 basis point tailwind. Overall, the net day rate impact for the full year is not meaningful. From a margin perspective, we expect Q3 to be our low watermark for the year from both a gross margin and operating margin standpoint. While gross margin will have less variability from quarter-to-quarter, we expect Q3 operating margin to step down sequentially between 150 and 200 basis points due to the normal seasonality of our business. We expect Q4 to step up significantly on a sequential basis, delivering our highest operating margin for the year. Importantly, we remain committed to investing for future growth while delivering meaningful full year margin expansion in 2023. We're really pleased with how our team is navigating a challenging environment. In summary, we delivered another quarter of excellent top line results, beating our expectations while managing very real supply chain challenges. We are building on our early momentum through continued execution and are again able to increase our full year guidance. We are also reiterating our confidence and expectation to be a 4% plus or even mid-single-digit top line grower in a normalized market while delivering strong earnings. In short, our business has never been stronger. With that, I'll turn the call back over to Keri.
Keri Mattox:
Thanks, Suky. Before we start the Q&A session, just a quick reminder to please limit yourself to a single question and one follow-up so that we can get through as many questions as possible during the call. With that, operator, may we have the first question, please?
Operator:
[Operator Instructions]. We'll go first to Travis Steed with Bank of America.
Travis Steed:
Good Morning Bryan and Suky. Nice quarter. I guess I'd start out with looking at the Hips and Knees in the quarter. I would think that knees 2x the growth rate of hip this quarter, backlog will be similar there. Is the elevated knee growth, mostly the mix shift from cementless and ROSA coming through? I'm curious how much supply is limiting growth in Hips and Knees here and what you're assuming about that improving in the back half?
Bryan Hanson:
Thanks, Travis. Well I think maybe I'll do because obviously, Ivan is here with us and as close to the action as any of us. So maybe I'll pass it on him to answer the question. Ivan?
Ivan Tornos:
I will say that the growth in knees is mainly innovation. We continue to see great momentum with ROSA penetration, so a pretty dramatic increase in penetration in the U.S. and core markets OUS. The launch of Persona OsseoTi or cementless launch is gaining great traction here in the U.S. In the prepared remarks, Bryan mentioned how we plan to go from 15%, 1-5 to 5-0- I won't disclose where we are in Q2, but it was a significant uptake in that side as well. We did also see great momentum in the ASC. We continue to grow here in the U.S. double digit in the ASC space. And yes, there was some backlog in key markets around the world. We saw better backlog consumption in EMEA than here in the U.S., but nonetheless backlog was part of the performance. And to the latter part of your question, certainly, supply was a governor. I do believe -- we do believe that in a normal environment with better supply or already very compelling growth rate could have been even higher. But all summarize backlog, innovation and great commercial execution were the key drivers behind the knee performance.
Travis Steed:
Great. And I guess looking forward that the sustainability of this kind of the plus and the 4 plus, and I think I heard the comment even mid-single-digit growth. It sounds like even with some tougher comps you're still confident in that seeing the plus in the 4 plus? And I assume that price is better. You got the mix of backlog is probably still lasting through 2024. I just kind of love to hear your confidence in kind of seeing the upside to that 4-plus?
Suketu Upadhyay:
Yes. Travis, this is Suky. So yes, very perceptive on our comments. Yes, we've got confidence in our business in a normalized environment that we're going to be at 4 plus or, as I said, a mid-single-digit grower. There's a few things. First, I focus on qualitatively execution is incredibly strong. Right now, we've got -- if you think about -- our WAMGR, weighted average market growth continues to improve. That's been steadily improving, one, by investing in R&D organically in higher-growth submarkets even within recon, but then in sports, Extremity and Trauma, and then if you look at the M&A that we've been doing, it's been in higher growth markets in Sports, Upper Extremities as well as CMFT. So overall, our weighted average market growth has been improving. Next, it's really around our innovation and what that innovation brings in terms of the ability to compete in the market, what it brings relative to share of wallet as well as mix is all very positive as well. And then the last is our performance relative to market. I think we've demonstrated for a number of quarters now that we can perform at or better than market on a consistent basis. So really execution is the primary driver why we've got confidence behind that. And secondly, you're also seeing some improving market dynamics. One, we think that overall, the patient dynamics are changing. You're seeing a lowering of the average age of our patients. That's expanding our overall market. Two, we think that they're getting more confident in the outcomes of recon procedures and sports procedures, again, because the technology, the innovation is improving, we're bringing real value to the marketplace. And I think the last thing is really the convenience and the comfort with the ASC setting is also helping to accelerate the overall market. So the market dynamics are still early and preliminary, but the execution is very strong and very real. So -- we've got a lot of confidence qualitatively. And I think if you look at the back half of our guidance, the implied growth rate of being roughly about 5%, I think that's another proof point quantitatively that gives us that confidence. So again, thanks for picking up on that. And those are the things that give us confidence.
Operator:
We'll go next to Richard Newitter with Truist Securities.
Richard Newitter:
Maybe just looking at the margins, I'm trying to calibrate if we're kind of back to normalized levels sustainably, what your normalized margin and margin improvement prospects are? You did about 200 basis points of year-over-year operating leverage in the first quarter, and you grew double digits on the top line. Now you're at about 100 basis points roughly in the back half, and that's like you said, a mid-single-digit implied growth rate on the top line. So can we assume like that -- those are basically the right level of operating leverage to correlate to call it, upper mid-single digits? You're getting north of 100 basis points, something more in the lower mid-single digits or upper low single digits, you're 50 basis points plus operating leverage?
Suketu Upadhyay:
Yes. So first of all, thanks for the question, Rich. I'll just step back a little bit and just say, if you go back to 2022 even in a very challenging market with a lot of inflationary pressure, supply chain disruption, et cetera, we were able to grow our operating margins. As you look at 2023, you take our implied guidance, it would suggest we're going to grow operating margins by almost another 100 basis points at the midpoint. So we feel really good about what the company has been doing. And inside of that, we've been doing that with very strong, as you've seen, mid-single-digit growth, very good gross margin performance. I'll break that down in just a moment. Offsetting continued challenges with inflationary pressures, but also inflation from '22 that capitalized into this year, which we've talked a lot about, while still investing against the business for future growth, right? So a very strong profile, good top line growth, good gross margin, offsetting the challenges and continuing to invest against the business. So I do think our ability to sustain these very high, very attractive margins this year into the future is absolutely table stakes, but I also think that we're going to be in a position going forward in a normalized market, where we're going to be able to expand margins from here. So that's how we think about things. I won't try and break down between what level of revenue growth, how much margin expansion. There are a lot of factors that play into that. The big picture takeaway is we're at a really good level now, we're going to sustain that, if not grow that into '24 and beyond.
Richard Newitter:
Okay. And just maybe feeding that into M&A. As we think about your M&A and tuck-in strategy, how should we think of the prioritization of top line from tuck-in M&A versus margin and earnings dilution trade-off?
Suketu Upadhyay:
Yes. So we know how to work around this as a leadership team. And clearly, what you see by looking at other companies in our sector is that valuations are correlated at a very high level to revenue growth. So understanding the ability to get our revenue growth at a higher rate. The mid-single digit is a great accomplishment given where the company was just 3 to 5 short years ago, and we're happy about the progress we've made, but we're not satisfied, right? And we believe that M&A, investing into faster-growth markets absolutely is the right thing to do and ultimately, we'll improve our overall weighted average market growth and the overall growth rate for the company. And then once you get there, you get natural leverage, the P&L starts to flow through and over time, you start to get to a profile where you get very strong earnings growth well ahead of revenue growth. And so that's the profile that we're going for long term. From an M&A standpoint, our first priority is that revenue growth and that diversification of the company into faster-growth markets. That may come with some near-term dilution, but we're also going to be very conscious about driving P&L discipline and looking for accretion in a reasonable amount of time, let's say, within the first 2 years. So that's how we think about M&A. The priority is going to be about accelerating the overall company's growth.
Operator:
We'll go next to Pito Chickering with Deutsche Bank.
Philip Chickering:
Can we touch more into S.E.T. You talked about strength in 3 focus areas, as process of supply challenges. What were those issues? Are they fixed at this point? And how should we be modeling S.E.T. in the back half of the year? And if the supply tunnels are fixed, should we think about bolus in the third quarter?
Suketu Upadhyay:
Yes. So a couple of things that inside the second quarter on S.E.T. One, we continue to work through some of the reimbursement changes in our Restorative Therapies business that we talked about a year ago. We believe we've now sunsetted those. So those shouldn't be a challenge as we move into Q3 and Q4, the rest of the year. However, we did see some pretty acute supply issues, especially in our Sports business and to a lesser extent, Trauma. That muted growth. But underneath that, our priority areas of Sports, Upper Extremities and CMFT all performed incredibly well. And so we're happy with the continued progress and momentum we're making in those businesses. We do expect an inflection in the back half of the year for those -- for the S.E.T. category as a whole to rebound. It's likely going to be stronger in the fourth quarter as we continue to work through the fluid situation on supply in the third quarter.
Philip Chickering:
Okay. Great. And then in the script, you talked about Russia getting growth. Can you walk us through a Russia could impact growth at this point and quantify the revenues and raw materials exposed to Russia?
Suketu Upadhyay:
Sure. So overall, Russia is less than 1% of total sales on a full year basis. We became aware at the end of -- towards the end of the second quarter, that new and unexpected sanctions were being placed on certain medical device products. Our products sell into that category. So we basically have to go back and reapply for licensing against all of our products. We don't think that, that's going to be a governor in perpetuity, but at least for the third quarter, it's going to create a bit of a headwind potentially a little bit into Q4 worst case. We think that, that headwind is roughly about 50 basis points in the back half of the year. And again, most of that will be felt in the third quarter. From a raw materials exposure, I think the biggest area, and we've talked about this at length -- our titanium supplies coming out of Russia have been relatively stable. That's a good sign. But we also took the additional measure at the end of '22 to create some redundancy and to find alternate suppliers, multiple suppliers outside of Russia. So we feel good about our titanium supplies.
Operator:
We'll go next to Jeff Johnson with Baird.
Jeffrey Johnson:
Kind of, I guess, we're ticking through all the segments here. So maybe if we just look at the Other segment, the 6% growth that was at least a nice step-up from what we've seen kind of on a trailing 12-month basis. Maybe any insights there what drove that and just kind of how we're seeing mix between leasing contracts and/or outright purchases on ROSA?
Suketu Upadhyay:
Yes, sure. Jeff, I'll take that, Suky again. I think the biggest driver was bone cement, not surprising when you see the recon growth numbers in the second quarter to see a very good other performance, especially for bone cement. We also saw some good performance outside in surgical as well, which also creeped up. Your last question inside of that was around ROSA placements versus outright sales. And consistent with prior commentary, we're seeing the majority of our ROSA placements or installments, I should say, being done through the placement strategy versus sales. So that trend continues.
Jeffrey Johnson:
All right. Great. And then maybe just a follow-up, just on backlog. I know you don't guide on backlog and any high-level comments though on how you're thinking about that backlog clearing in EMEA and what you saw in the U.S.? And just kind of comfort with that backlog still continuing to provide some tailwinds maybe over the coming year or 2? Thanks.
Suketu Upadhyay:
Yes, definitely felt that in the second quarter as we talked about. That helped offset some of the supply challenges that we had. We expect backlog to continue to contribute through the rest of this year. It's always difficult to determine exactly how much was in any given quarter and to predict how much will come through. It's a little bit of amorphous, but we know that it's there, and we have high confidence that it's going to -- we're going to continue to see it through the back end of this year and likely through 2024.
Operator:
We'll go next to Larry Biegelsen with Wells Fargo.
Lawrence Biegelsen:
Congrats on a nice quarter here. I'll ask a couple on the pipeline. Persona iQ, do you guys have what you need now for a full launch from a clinical data standpoint -- and if so, what data are you going to promote and file for the label? And I had one follow-up.
Ivan Tornos:
Absolutely, Larry. I'll take that one. First and foremost, we remain on track with our limited market release. We've been saying all along that by January Q1 of 2024, we'll be ready for a full launch. And I will say that we're almost there in gain on the data. We're approaching 1 billion data points from multiple patients thousands of implants by now. And really we're answering 3 questions. Number one is, to your point, what is the value proposition? Can we demonstrate a reduction in the length of the episode of care? Can we bring objectivity to a range of motion metrics? Can we demonstrate better gate performance given better technique, better surgery? Can we compare recovery curves? Who does better post implantation? There's a lot of data we get in that regard, and we'll be filing some claims once we digest the multiple data points that we're getting. So that's question number one. Question number two in the limited market release is how do we make the whole thing seamless? This is new to the word technology. It's got a home base station, as you know. It involves the patient, involves the surgeon, the caregiver. So we want to make sure that is a best-in-class experience, and there are some things that we're working around. And then the third question, and I know this is near and dear to you is who's going to pay for the technology? To that end, we got the NTAP kicking in at the beginning of October. You'll be pleased to know that we follow up with your question around TPD, transitional pass-through. We had a deadline of August 23 to submit. We're in the final stages of evaluating what the submission could look like. We're evaluating commercial payer strategy as part of this limited market release. So we continue to think about the payer as well. So with all of that said, the what, the how and the who will pay, I think going to be in a good position to start to see a full market release by January, if not late Q1 2024.
Lawrence Biegelsen:
Ivan, thanks so much for that comprehensive answer. Maybe another one for you. On the Robot -- for the shoulder application for the Robot. I think you just confirm that you still expect to be first to market and what need -- what still needs to be done? And if you'll give any more color on the time line? That would be great.
Ivan Tornos:
I'd love to give you more color, but Bryan and Keri will shoot me. I will tell you that we remain convinced capital letters that would be first to market in Shoulder Robotics, and beyond the speed to market, what I like is what the actual platform offers. Faster surgeries, more accurate outcomes, shorter recovery. So a lot what we've seen, we've done our final validation labs with customers, both friends and family customer surgeons and also competitive surgeons and the feedback has been outstanding. Beyond the platform dynamics that I mentioned around shorter recovery, faster surgery, I just love the integration that Russia shoulder will have with the rest of the CDH ecosystem. So more than that soon.
Operator:
We'll go next to Ryan Zimmerman with BTIG.
Ryan Zimmerman:
We all heard United Healthcare's comments this quarter. It was evident in results, but it was specific to recon on Medicare. I'm just wondering if you can kind of parse out the procedure environment within S.E.T.? It's hard to see given some of the supply chain dynamics. I'm just wondering if you can kind of speak to that environment relative to recon in your expectations for durability of its robustness, if you will? Through the remainder of this year, similar to the recon environment.
Ivan Tornos:
Ryan. I'll take that one as well. So obviously, it varies from region to region. What I will tell you here in the U.S., we saw greater backlog consumption coming from Knees and Hips. It was actually quite the opposite in EMEA. When it comes to S.E.T., a lot of those cases here in the U.S. are done in an ASC environment. And other cases, are commercial payers, and it's been pretty consistent. But again, it varies quarter-to-quarter, geography to geography. We do believe that the backlog is going to be here for a while, and we'll see fluctuation given ASC non-ASC in the U.S. And then again, different variables outside of the U.S.
Bryan Hanson:
I think the key takeaway you just don't see as much impact on the S.E.T. business as you do the Recon business when you think about backlog.
Ryan Zimmerman:
Fair. That's helpful, Bryan. And then we talked about Russia. Last year, it was China and the impact of BBP. I'm just wondering if you could articulate specifically what the status is in China? We've heard from many of your peers, China is improving. What are your expectations for China growth? As we kind of lap -- as we start to lap the BBP impacts?
Suketu Upadhyay:
Yes. So first of all, BBP is not a material driver for us at all in 2023. We sort of turned the corner on that between the end of '21 and 2022. So we actually see China as a growth driver for us, albeit at a lower level, but we do believe that, that market has some very strong growth for us. I'd say pre-BBP, that market was growing in the low double-digit range. And we'd be surprised if we didn't return to that level, if not better.
Operator:
We'll go next to Mike Matson with Needham & Company.
Michael Matson:
Back to the S.E.T. business. So Bryan called out kind of the subcategories there that seem to be the area of focus. But the things I didn't hear a mention were lower extremities, i.e., foot and ankle or trauma? So can you maybe just comment on why those were kind of left out of the comments?
Ivan Tornos:
Yes, sure. I can do that as well. So I think Suky alluded to the trauma headwinds that we had in the quarter. We had some supply challenges. And obviously, you got the comp in China versus a year ago. Here in the U.S., there were some contracts that we lost about a year ago. We're anniversarying out of those. There were some product launches that were delayed, '22 and '23 that are coming out now. So I will say that moving forward, given the better comps or U.S. and the contract capabilities now in the U.S. along with innovation, the trauma business is going to be in a better position. Foot and ankle has been one of the businesses, frankly, within S.E.T. that we didn't prioritize. We wanted to prioritize upper extremities, SportsMed and CMFT. That being said, I do think there is a couple of product launches that are going to make a difference in the space. So all in all, I do think you'll see better performance. But trauma, foot and ankle are not the key priorities within S.E.T.
Bryan Hanson:
Yes. And to be clear, it doesn't mean that we don't see foot and ankle, trauma and restorative therapies as potentially attractive markets. It's just we want to be disciplined in the way that we're going to invest -- and the -- if you look at the strat plans that we have for upper extremity, CMFT and Sports, they're very attractive. So we're going to focus our investment there. Out at the end of the day, the individuals running foot and ankle, trauma or restorative therapies, put a plan in place that's attractive, they could become growth drivers. But today, we want to differentiate those growth drivers to non-growth drivers, nothing against any other categories. It's just the plan right now is very attractive in those 3.
Ivan Tornos:
And just on restorative therapy, that was restorative therapies was part of your question, but we anniversary out of the reimbursement change, July of 2023. So you should expect that business to do dramatically better now.
Michael Matson:
All right. Got it. And then just in terms of the supply chain issues, I don't know if it's possible, but is there any way you could quantify the impact either to your revenue growth and/or your margins in the quarter?
Bryan Hanson:
I think we'll try to stay away from quantifying, it's pretty challenging, actually, because when you talk about supply issues, you always get feedback from the field on what could have happened if you had more supply and you've got to make sure that you're kind of sifting through what's real, what's not. But the fact is it is a governor for us right now, and that's why we continue to say it. What's important, though, is it's a macro-challenge. There's not a company in orthopedics right now that is not being impacted by supply challenges. So it's impacting everyone. AAOS just did a survey actually with surgeons asking this question and across the board regardless of who they were using, they were experiencing supply challenges. Really important thing for us that's built into the guidance that Suky just provided. So that's key. But when I think about that growth driver, the impact it's having on our ability to grow. I think it's important to look at that. That means is getting in the way of our team using new innovation to drive mix benefit and competitive conversions. We truly do believe that it was not a factor. We'd be getting more mix benefit, we'll be getting more competitive conversions because the demand is there. So it's frustrating. We have great momentum in the business, great innovation and supply is in the way of driving that growth. And we believe it's going to continue to be there for a period of time.
Operator:
We'll go next to Robbie Marcus with JPMorgan.
Robert Marcus:
Congrats on a good quarter. Maybe I could start on margins. If I take the third quarter and fourth quarter commentary that you provided, I have a little trouble getting to the high end of the range. So maybe just speak to some of the pluses and minuses there and what you need to get to the top of the range? And then second question, I'll just throw in as well. You have a big gross margin benefit from currency in '23. There's a pretty wide range of operating margin expansion next year or contraction on The Street. Any early thoughts into how we should be thinking about your ability to grow operating margins next year?
Suketu Upadhyay:
Sure, Robbie. Great to talk to you. So one of the biggest drivers in the overall profile in the back half of the year, by the way, we do believe operating margin in the back half will be modestly better than what you saw in the first half. That's largely going to be driven by better revenue, mostly coming from the fourth quarter. Fourth quarter is always our strongest from a dollar perspective, from sales view. The second thing is you're likely going to see a step down in overall operating expenses from the second quarter. That was sort of our high watermark as we were dealing with a number of inflationary pressures. But quite frankly, also investing pretty handsomely against things like R&D, which was up like 19% in the quarter, investing against commercial infrastructure in places like sports and upper extremities to continue to specialize that sales force as well as ASCs. So the two common combined things of higher revenue, lower OpEx as we move into the back end of the year is what's going to drive that margin expansion improvement versus the first half. As we look into 2024, you're right, we did talk about some FX hedge gains this year, which we sized at about 50 basis points on the full year that won't repeat into next year. That will be a headwind, but we're still confident that we can grow operating margins into 2024. It may not be at the same level of 100 basis points that you're seeing this year. But we do believe, as I said earlier, that we can take this sort of high watermark that we are in operating margins that continue to enhance that as we move into 2024. What are some of the building blocks? One, pricing is still a headwind, but we're seeing really great performance. It's not the headwind that it used to be for the company. And what's even more exciting about that is we're truly seeing very strong mix benefit inside the company, and that's coming from our new products and the innovation into the marketplace, which is helping to offset that price erosion. So we think that, that can be a tailwind for us. Secondly, we continue to work aggressively on our site optimization in manufacturing and supply chain, which we think can generate some tailwind in cost of goods as we move forward. And then as you move through the rest of the P&L into SG&A, there's still ample opportunity with our Global Business Services agenda that we just started a few short years ago. We've got a completely different culture and mentality when we think about go-to-market and market profitability. Where at one time, it was revenue growth at all costs. And now it's all about revenue growth at the right profitability level and with earnings growing faster. And so there's just those cultural shifts and that discipline is also driving some really nice margin expansion both in the U.S. as well as outside. So these are just a few levers that quite frankly, we've been pulling on already. There's still room to go and why we feel confident that we can take this high watermark for 2023 and grow it into 2024.
Operator:
We'll go next to Rick Wise with Stifel.
Frederick Wise:
And maybe starting off with a couple of the key new product launches that you highlighted. Bryan, you said as you were talking about the 4 pillars of Knee growth that ROSA+ the cementless Knee launch, were -- that was your first comment, your first focus area, taking cementless from mid-teens to 50% over time. Related to that point, where are you in the rollout? When, or are you even at full launch now or what's required? And how do we think about the acceleration of that launch over the next year or 2?
Bryan Hanson:
Thanks, Rick. What I'd say first is just to make sure that I clarify. I'm saying that both ROSA and cementless will move from the mid-teens to 50% plus, 5-0 percent plus. So not just cementless. And they kind of do play off of each other. They benefit each other as they're trying to get adoption in the marketplace. But speaking specifically to cementless, maybe I can pass that to you.
Ivan Tornos:
Yes, I would say, Rick, that it's early innings, frankly, both for ROSA as well as cementless. We are in what I think is not still a full launch for cementless, given some of the supply constraints. I think as we exit 2023 and early 2024, we'll have as much supply as we need to meaningfully drive the penetration of cementless with a goal of going from 15% to 50%. I won't say when 50% is going to happen, but that's definitely the North Star. ROSA is the same situation. We launched 2 platforms in Knee. We are about to launch ROSA Partial this summer, a new and improved version of that. We're working actively on next-generation total knee, which will be a meaningful launch going into '24. We got all kind of ZBEdge add-ons data technology solutions that are going to augment the penetration there. But I would say net-net, both for ROSA, cementless and some of the peripheral launches around those 2 components, we are in the early innings.
Frederick Wise:
Great. And Bryan, if I could, for a second question, I would like to hear from you your personal priorities. It seems like execution is going well. Ivan did a great job, and the team is doing a great job with the pipeline and execution and driving the business forward, Suky is taking the financial organization in a positive direction. What are your priorities now as you look ahead to the next year or 2? Are you focused on efficiency portfolio? What just -- what are you thinking about and that we should hear about and ask about today?
Bryan Hanson:
Thanks, Rick. I mean I'll kind of tongue-in-cheek say we're thinking about everything. But obviously, that doesn't get you anywhere you focus. And we've been very clear from the very beginning that we had 3 phases of the transformation of this company. Phase one is always going to be alive, but we're in great shape Phase 2 is kind of what you just said. We have a great innovation pipeline. We're executing from an organic standpoint. We feel very confident in that phase. And now we're squarely in Phase 3, as we've been saying, and the big focus for us is that portfolio transformation that will leverage our balance sheet. And the balance sheet is strong and strengthening us in the prepared remarks, and that is the area of focus for us. How do we continue to move our weighted average market growth forward. I can tell you we've already made great progress in the focus area here. We've already moved it North. With the balance sheet strength, we expect it to continue to move in the right direction. So that's an area of focus, not just for me but for this entire team.
Operator:
We'll go next to Josh Jennings with TD Cowen.
Joshua Jennings:
Hi good morning...
Bryan Hanson:
Do we still have you?
Unidentified Company Representative:
I think he got electrocuted...
Keri Mattox:
No, Josh, we hope you are okay. Katie maybe we can go to the next one in the queue, and then hold Josh back if he dials back.
Operator:
We'll go next to Jayson Bedford with Raymond James.
Jayson Bedford:
I guess -- I apologize if I missed this, but what was the impact of price in 2Q and of your expectations around price changed at all?
Suketu Upadhyay:
It was about 1% erosion year-over-year in the second quarter. I think in the first quarter -- I think the average is somewhere around for the first half of the year. We would expect in the second half or somewhere to be between 100 to 150 basis points of erosion. We're seeing really good traction there for the number of reasons that I've talked about at length previously. But again, I think the really exciting thing is we're starting to see that mix benefit come through from our new product introductions and helping to offset even an improved price erosion profile.
Jayson Bedford:
Okay. Great. And then just secondly, on the supply challenges, are these new issues or the kind of legacy carryover issues? And then Bryan, I think you mentioned that you expect this dynamic to continue for some time. Does the impact lessen with each quarter going forward? And any visibility as to kind of when these issues will abate?
Ivan Tornos:
I'll start by saying that we have not seen anything new. All along, there were really 3 buckets that summarize the problem, materials, labor and sterilization, augmented with, frankly, just put demand plan on aside because the demand that we felt kept getting better and better and better. Sequentially, we've seen improvement. We've seen better forecast accuracy on the demand side. And then as we think about labor, at the Tier 1 level, our labor capabilities are much better than before. We're hiring people in our sites. When you think about sterilization, we had the right strategies, materials continue to be a challenge, but again, it's much better than before. So I would say improvement versus the past. And sequentially, we continue to see improvement across both supply and demand.
Bryan Hanson:
I mean the challenge, it's a fixed equation, right? I mean as you start to improve as we would expect in materials, labor and sterilization because we've put great planning around that, as demand continues to be strong, it's going to delay supply recovery. And so that's what we're seeing is we're seeing a great dynamic strength in the marketplace, better traction in our new innovation than we even expected, but that puts pressure on that equation, and it pushes the supply challenges out.
Keri Mattox:
Thanks so much, Jayson.
Operator:
We'll go next to Kyle Rose with Canaccord.
Kyle Rose:
Suky, on -- just circling back on gross margins, strong in 2023, obviously, you walked through some of those benefits. I guess just help us understand maybe how much of an impact inflation in the supply chain has been on underlying gross margins? I mean I understand the positive tailwinds that you've outlined earlier. But how much have you truly been offsetting? And I guess just trying to understand how much -- when you talk about supply chain challenges and increased unit costs and wages, are we still -- is there a potential to see a second shoe drop? And I'm just kind of trying to understand as inventory turns flows through the business if and when we'll actually ever see that impact through the P&L? And then secondly, let's talk about returning to a normalized operating environment. I think we all understand it's been a dramatic 3 to 4 years. But I guess just -- when is it fair to start thinking about when we will be in that more of a normalized operating environment, whether it's supply challenges the industry is facing, staffing challenges. Just how should we think about actually getting step back to that mid-single digits?
Suketu Upadhyay:
Yes, sure. Kyle, thanks for the question. So first, on gross margin, from an inflationary standpoint, recall that we have about 100 basis points from '22 that's capitalized and hitting our P&L this year, and we're seeing that come through, that's happening. In addition, we are seeing some incremental inflationary pressure, new pressure 2023, primarily related to continued spot buying with some raw materials around packaging, [indiscernible] some of our metals that we use, but we're also seeing it in really the cost to serve. What do I mean by that, really around the need to have to shift product a lot more than you might have to in a stable supply environment. That's one area of incremental inflation or higher costs that we're seeing. Second is we've made the decision to actually pay incremental incentives to our commercial field sales force because we know how challenging it is out in the marketplace. Dealing with these supply challenges, we've been incredibly impressed with how they've been responding. So these are a couple of elements that are also flowing into the P&L. By the way, we're offsetting those and investing into business while increasing operating margin for this year. So the company and the team have been incredibly disciplined in the backdrop of better revenue and still dropping very, very substantial operating margin expansion. As we move into next year, there could be some of this incremental inflationary pressure that we're seeing this year that makes its way into 2024. It's going to be nowhere near what we saw happen in '22 into '23. It will be much more modest. And like I said, I think we have more levers to help offset that as we move into 2024. But again, I'm not going to give guidance on 2024 and exactly what gross margin or operating margin looked like. But there are some moving parts there. That will be potentially another modest headwind. But again, we have a number of tailwinds to help offset things returning to a normalized market. Clearly, we're not there yet. Revenue growth may look and feel normal, but the underlying dynamics are still not normal. We don't believe, at least standing where we are today, at least the beginning part of 2024 that we're going to be there. It's a long way away. We'll see where we get to in 2024. But once we do get to that sort of normalized growth, we do believe that we can sustainably hit that 4-plus or mid-single-digit growth profile that I talked about earlier.
Keri Mattox:
All right. Katie, I think we might have time for one last question in the queue.
Operator:
We'll go next to Matt Miksic with Barclays.
Matthew Miksic:
So just a couple of follow-ups. One on margins. And I know there's been a fair amount of talk about on the call and progress in terms of driving leverage commitments to leverage this year. I was wondering if we could sort of zoom out and think about where margins were pre-pandemic in that kind of like low 30s range? If you could remind us, is that -- is that a target to get back to and maybe the time line for getting there? And then just one quick follow-up on the Persona iQ, if I could.
Suketu Upadhyay:
Yes. So the margins in the low 30% range. I'm not sure what you're referring to there, Matt. Maybe just out there the merger of Zimmer and Biomet. But since then, those margins were obviously impacted by a lack of investment in supply chain, commercial infrastructure, et cetera. So again, I don't know that, that's the right reference point -- what I can tell you is that pre-pandemic to where we are now, we are expanding margins, operating margins as we continue to drive top line revenue growth and investment in the company. So feel good about where we are and where we're headed moving forward. Sorry, your second question?
Matthew Miksic:
Sure. Just a follow-up on Persona iQ. I think the number, I think maybe that was mentioned earlier was something like 1,000 implants. I mean that's a pretty -- it's a pretty small percentage of total maybe 1%, less than 1% of your total implants a year. And I just want to get a sense of at what level do some of the data start coming through? Is it a couple of thousand implants? Is it 300 to 500 implants? When do you expect seeing some of the results you mentioned earlier in the call?
Ivan Tornos:
Yes. Thank you, Matt. First and foremost, we don't disclose the number of patients, but I'll tell you, it's far greater than 1,000 patients. When are we done with the limited market release? I think we're about to complete that? The size matters more for certain claims than others, but I will tell you, we've got enough of a sample size to be able to engage in a full market release by 2024. What's the expectation going forward, this is going to be a flagship product for Zimmer Biomet. We plan to see meaningful penetration of this technology. First in Knees, then in Hips and then at some point in Shoulders as well. What's the right penetration? Again, we won't disclose that. But given the unique technology, we will leverage this to the fullest.
Keri Mattox:
Thanks, Ivan, and Matt thanks for your question. I think we're almost at the bottom of the hour. I'll actually turn it over to Bryan just for some closing remarks.
Bryan Hanson:
Just maybe a quick summary to on what -- but you were just talking about Suky, when we think about a normalized market. And we're saying 2024 in our view, is not going to be normalized for 2 factors. You're still going to have backlog that we're going to have to pay attention to. We would deem backlog is a neutral to potentially negative depending on whether it stays the same or decreases. We don't think there's going to be an increase in it. And the second one is supply. That is going to be neutral to positive because as we continue to see supply benefits that will create a tailwind for next year. So those are pretty big variables that would tell us that we don't have a normal year in 2024, but they're offsetting. So that's the reason why we think 2024, even though "not normal" could look a lot like a normal year from a growth perspective. I just want to make sure that, that's clear. And then just going to sum it up, first of all, thanks again for joining us this morning. And I think it's pretty clear in the way that we talk about the business right now that we're not just excited about where we are as a company, but the future of this company. And I think that's really important. We've already made disciplined portfolio decisions that have increased the weighted average market growth of this business that's already happened, and that gives us confidence in the growth of the organization, not just today but in the future. And the balance sheet says that we're going to continue to be able to strengthen our position in those fast-growth markets and we will absolutely do that. That is Phase 3 of the transformation. And the innovation pipeline as Ivan continues to talk about is as strong as it's ever been, and that gives us the ability to drive mix benefit, pricing stability and competitive conversions. And when supply gets out of the way, that will even happen more. So we're very excited about it. And I've been doing this long enough to know when the team has got that skip in their step. And they've got the ammunition to be able to drive the performance of the business sustainably. And we are in that place. Okay. With that, I'll go ahead and close it out, and thanks for joining us.
Keri Mattox:
Thanks, everyone. We'll talk to you soon. And obviously, if you have any further questions, please don't hesitate to reach out to the IR team.
Operator:
Thank you for participating in today's conference call. You may now disconnect.
Operator:
Good morning, ladies and gentlemen. And welcome to the Zimmer Biomet First Quarter 2023 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today May 2, 2023. Following today's presentation, there will be a question-and-answer session. At this time, all participants are in listen-only mode. [Operator Instructions]. I would now like to turn the conference over to Keri Mattox, Chief Communications Officer. Please go ahead.
Keri Mattox :
Thank you, operator and good morning, everyone. We're joining you from our Warsaw Indiana headquarters and are happy to be with you today. Welcome to Zimmer Biomet's first quarter 2023 earnings conference call. Joining me are Bryan Hanson, our Chairman President and CEO; EVP and CFO, Suketu Upadhyay and COO, Ivan Tornos. Before we get started, I'd like to remind you, that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by the forward-looking statements, due to a variety of risks and uncertainties. Please note we assume no obligation to update these forward-looking statements even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties in addition to the inherent limitations of such forward-looking statements. Additionally, the discussions on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within our Q1 earnings release, which can be found on our website, zimmerbiomet.com. With that, I'll turn the call over to Bryan, Bryan?
Bryan Hanson :
All right. Thanks, Keri. And thanks to everyone for joining us on the call this morning. We don't get the opportunity to do this too often. So I'm going to take advantage of it. And I'm just going to start the call by simply saying this was a phenomenal quarter, where pretty much everything went better than expected. And importantly, as a result of that momentum, we are significantly raising our full year top and bottom line outlook, which Suke Upadhyay is going to talk about in just a minute. With that said, and maybe taking a step back, for today's call, I'll talk more about our Q1 performance and the drivers of that performance. And then Suke will get into more details for the quarter and importantly, also our financial guidance for the rest of the year. And then we'll make sure that we save plenty of time for your questions which we look forward to addressing. But before we do any of that, I just want to take a minute to speak directly and personally to the ZB team. And it really just say thank you, truly say thank you. For yet again, you have delivered beyond our expectations. And I'm very proud of what this team is doing to navigate an environment that while improving, there's no question it's improving, it is still fluid. And it presents us with challenges that quite frankly seem like daily challenges. And it is truly impressive how you're navigating that environment right now. And I'm very proud of the dedication, the resilience and the innovative thinking that you're bringing to your roles each and every day. It is truly making a difference. But I'm most proud of how together and I do mean together, we are living the ZB mission to alleviate pain and improve the quality-of-life for people around the world. And as we know, we do that every eight seconds, 24 hours a day, seven days a week, which is really what it's all about in the first place. So thank you. Thank you for what you do for ZB, thank you for what you do for our customers and most of all, and most importantly, what you do for our patients, the patients that we serve every day. Okay, so let's take a look now at the first quarter. And as some of you may recall coming into the year, our guidance assumed that Q1 would have the easiest comp of the year, but also experienced some headwinds from both staffing and COVID-related challenges that we felt would put pressure on elective procedures during the quarter. We also assumed that there would be a pretty high level of supply pressure in the first quarter. Our assumptions also believed that all three of these headwind variables would then improve throughout the year providing less impact to the business. But then outside of the easy comp, Q1 would be pretty bumpy. Okay, so what actually happened in the quarter? And why was it considerably stronger than we expected? Well, first and foremost, procedure recovery was much better than we anticipated, really having almost no material or meaningful impact from COVID or staffing challenges in the quarter. And second, we manage the supply constrained environment better than we originally anticipated. Make no mistake, supply is a real problem. And it's putting pressure on the business. But this team has done an excellent job managing that environment, probably leveraging some muscle memory from the past. And then third, and I think really importantly, our team's execution and traction with our new product innovation is even stronger than we anticipated. And that's important because it's going to continue to provide benefit to the rest of the year. And so because of this, we saw another quarter of very positive year-over-year momentum in large joints, with our global hip and knee businesses growing approximately 13% and 18% on an ex-FX basis. Our overall S.E.T. category grew more than 6%, driven by strong low-double-digit performance in our growth drivers in S.E.T. which we've talked about before being sports, CMFT and upper extremities. And then this was partially offset as expected, from headwinds from our restorative therapies business, where these headwinds will anniversary, and as you remember, these are reimbursement change headwinds that we have in that business, they should anniversary by the back half of this year. And then finally, our other category grew 11% in the quarter. So needless to say it was a pretty strong quarter. And the momentum is real in this business and our confidence is extremely high. And there's good reason for this competence. If we just think about this quarter alone, we officially launched our new cementless knee form factor Persona OsseoTi, and this is adding to the Persona family and really strategically rounding out that portfolio. And this new keel design tray is extremely versatile, it's anatomic because it is the Persona family and it's stable. And it's the only knee that you can do a cemented or cementless procedure with an inter operative decision possible for the surgeon. And that's a big deal. We believe that this will enhance the potential for cementless penetration, because surgeons can go into a questionable bone quality procedure with the intent to use cementless, but then they have the ability to pivot back to cement it as the bone quality isn't there. And for this reason, and a lot of other reasons, customer feedback so far has been extremely positive, as we've launched this product. And as you may know, our cementless penetration is already in the mid-teens. But we believe that this can get to 50% or higher penetration. And we're excited about that. And we truly do believe that this premium product can accelerate that growth for ZB and is already doing so. It's still early days. Our full launch is planned for the middle of this year as more sets become available. Make no mistake, this is a real driver for not just our knee franchise, but for the overall company. So we're very excited. As you remember, back in February, we also closed our acquisition of Embody, which is providing access to differentiated products and an innovative pipeline for our sports medicine business. And this investment helps expand ZB's presence in this very attractive high growth market, while also in that market, serving our customers and our patients better. And this combined with a very strong innovation pipeline that we have in sports, and this dedicated commercial channel that we put into place gives us continued confidence in our global sports franchise. And if you're at the AAOS meeting, you would have seen that we previewed our Hammer product, which is designed to ensure consistent and reproducible compaction for hip procedures, while allowing the surgeon to dial up or dial back the force of the strike, depending on the individual patient need. And this ability to be more personalized, actually differentiates Hammer versus other compaction devices on the market. So needless to say, we're excited about this differentiated product. We believe this could actually increase not only the consistency for surgeons, but also the procedure efficiency, which is really important right now. And our current expectation is to launch Hammer in the third quarter of this year. And if you just look at these combined products, this is actually building on other launches that we've talked about the Persona IQ, Hip Insights, the Identity Shoulder system, and in total, we've introduced more than 50 new products from 2018 through the end of 2022, with the majority of those products coming in markets growing 4% or faster. And we're geared to continue that momentum, doesn't stop here with another 40 planned product launches between this year and the end of 2025, again, with the majority of those products to be launched in 4%-plus growth markets. And this shift not only continues to transformation of our product portfolio, because the short term revenue growth, but it also improves our weighted average market growth. And ultimately, as a result of that gives us more confidence that our markets and our portfolio mix positions to company for sustainable mid-single-digit growth. And with this kind of traction around our product pipeline, increasing strength of our balance sheet, and our team members' ability to execute, ZB continues to be well positioned to deliver value today and in the future and achieve our mission as a company. And with that, I'm going to turn the call over to Suke to take a closer look at Q1 and our latest expectations for 2023. Okay, Suke.
Suketu Upadhyay :
Thanks, and good morning everyone. As Bryan mentioned, we had an excellent quarter with better than expected results. As a result of continued market normalization and the strength of our performance, we are increasing and narrowing our full year financial outlook. With that, let's turn to our results in updated full year guidance. Unless otherwise noted, my statements will be about the first quarter and how it compares to the same period in 2022. And my commentary will be on a constant currency and adjusted operating basis. Net sales were $1.831 billion, an increase of 10.1% on a reported basis and an increase of 13.2%, excluding the impact of foreign currency. As we noted on our last call, we had a selling day tailwind of about 100 basis points this quarter. Overall, the business back from faster than expected recovery of elective procedures driven by the easing of staffing related headwinds, normalization of cancellation rates, and some backlog recapture. Also, we've benefited from lighter comps, strong commercial and supply chain execution and new product uptake. While we continue to face macro supply headwinds, our teams have been doing a great job mitigating these challenges. U.S. growth of 12.7% was well ahead of our expectations with elective procedure volumes recovering and procedure cancellation rates returning to pre-pandemic levels. International sales grew 14%, EMEA growing ahead of expectations, driven by faster recovery and strength across both developed and emerging markets. And in APAC, we saw some pressure in China as anticipated, but results were generally in line with our expectations. Turning the business category performance, global knees grew 18.2% with us growing 18.1% and international growth at 18.2. Specifically, we saw strong uptake across the full Persona product portfolio and traction in all regions. We now have the Persona, Primary, Partial, Revision and OsseoTi cementless options rounding out our full product line. And we are seeing very encouraging results across that new cementless form factor. This full Persona product line not only improves and enhances our product mix benefit, but also supports the continued utilization of Rosa and associated pool through. Global hips grew 12.9% with U.S. hips up 12.3% and international up 13.5%, driven by continued traction across the Avenir and G7 product lines, along with ongoing uptake of Rosa hip. And we are encouraged by the early impact of the Hip Insight launch. The S.E.T. category grew 6.4% driven by continued strong performance across our key focus areas of CMFT, sports medicine and upper extremities, all of which grew in the teens. This was partially offset by lower growth in other parts of S.E.T., which includes the reimbursement changes in restore therapies that will anniversary mid this year. Finally, our other category grew 11.1% partially driven by some larger orders and surgical products which may not repeat over time. Moving to the P&L. For the quarter, we reported GAAP diluted earnings per share at $1.11, compared towards GAAP diluted earnings per share of $0.35 in the prior year. While investments in R&D and commercial infrastructure increased, net earnings were higher this quarter driven by revenues improve gross margins and losses in the prior year related to ZimVie. On an adjusted basis diluted earnings per share was $1.89 represents a 17% increase from $1.61, in the first quarter of 2022. Adjusted gross margin was 72.8%, up 220 basis points from the prior year. These results were positively impacted by favorable mix related to large joints performance and foreign currency hedged gains. Excluding these items, underlying gross margin was broadly in line with our expectations related to inflation. We're seeing some incremental pressure from spot buying and contract manufacturing pricing, but overall inflationary pressure has largely stabilized. Our adjusted operating margin for the first quarter was 28.4%, up 200 basis points primarily driven by revenue better gross margin and continued discipline around our investment profile. Interest in non-operating expenses of $46 million and our adjusted tax rate of 16.3% were broadly in line with our expectations. Turning to cash and liquidity. Operating cash flows were $308 million and free cash flow totaled $178 million. We ended the quarter with cash and cash equivalents of approximately $330 million. And moving to our updated financial outlook for 2023. Based on strong Q1 results and our ongoing strong execution, we are raising and narrowing our full year 2023 outlook. Constant currency revenue growth is now expected to be 6% to 7% versus 2022, with an expected foreign currency exchange headwind of 100 basis points. We're also updating our adjusted EPS guidance range now expecting $7.40 to $7.50. While we initially gave color that adjusted operating margin would be flat to slightly better in 2023, or Q1 results in tandem with an improved rest of your outlook gives us the confidence that we will expand operating margins this year. We continue to expect interest and other non-operating expenses, along with our tax rate to be in line with our previous commentary. Finally, we now expect free cash flow for the year to increase to a range of $1 billion to $1.1 billion. In terms of quarterly cadence throughout the year, our expectations remain unchanged. Q1 will be the highest revenue growth quarter followed by Q4, which should benefit from improving supply and contribution from new and innovative products, as well as a selling day tailwind of about 100 basis points. Q2 and Q3 are expected to be lighter growth quarters given tougher comps and a net selling day headwind of about 100 basis points. Again, selling days will have a net neutral impact for the full year. We expect adjusted operating margin to largely follow revenue with second half operating margins being slightly better than the first half. In summary, we delivered excellent top-line results, beating internal expectations in nearly every category while posting very strong adjusted earnings performance. Our business is executing well our pipeline is delivering and our momentum is real. We feel very confident as we move forward. With that I'll turn the call back over to Keri to start the Q&A.
Keri Mattox :
Thanks, Suke. Before we start the Q&A session, just a quick reminder to please limit yourself to a single question and one follow-up so that we can get through as many questions as possible during the call. With that, operator, may we have the first question, please?
Operator:
We'll take our first question from Steve Lichtman with Oppenheimer.
Steve Lichtman :
Good morning, guys. And congratulations on the quarter. I guess, first one, I want to start on the knee and hip market. Obviously, very strong for ZB and for the market. As you noted comps play a part. I was wondering if you could talk about what you think sort of underlying market growth here is, and maybe talk a little bit about procedure growth and where sort of pricing stands as well?
Suketu Upadhyay :
Sure, Steve. Thanks for the question. This is Suey and hello to everyone on the call. The first thing I'd just step back, overall, we had a very good first quarter, as you can see from the results. And it was really across all of our business segments, including all of our regions, and that flowed through all the way through the P&L. So really happy about the quality and the execution of the entire team. We did always think that Q1 would be our strongest growth quarter. We talked about that when we gave our initial guidance for the year. That was really two key drivers. One is you had a strong comp benefit versus the first quarter of 2022. Clearly, we were still dealing with Omicron back in 2022. Secondly, we talked about a day rate tailwind of 100 basis points. So we knew year-over-year that we would see strong growth. But we achieved better than that and really across every one of our business segments, as I pointed out earlier. But recall where our expectations were before. We thought we would continue to see some procedural volume challenges and staffing challenges and also supply chain headwinds. So that underpinned our previous guide. But we actually overachieved relative to those macro factors. Where we just didn't see as much staffing or COVID pressure. We also saw some backlog come into the marketplace. And so from a macro standpoint, it was better than we expected. And then also our execution was incredibly strong. Our innovation was very strong across commercial but also supply chain. So really happy with where everybody sort of executed for the quarter. And we think that, that store will going forward. Relative to your specific question on the overall market growth rates. I would just say, look, we're not yet in normal market growth. You clearly continue to have some choppy comp comparisons versus the prior year. We do still think we're going to continue to face some headwinds relative to staffing and of course, supply chain continues to be a very real challenge out there, partially offset by some backlog tailwinds. So again the markets, I think, are anything but normal yet. But I would say they're very strong, they're improving and normalizing, and we're very encouraged about where they're going. Pricing in the quarter was a little bit, I would say, kind of in line with where we expected it to be. We always talked about this year being a bit better than the traditional 200 to 300 basis points that we've seen historically. And at 140 basis points of erosion that was right in line with where we expected to be.
Steve Lichtman :
Great, thanks. And one product on the new side that is yet benefiting you is on a Persona IQ. I was wondering if you could give us your updated thoughts on that, how the limited launch is going and maybe your latest thoughts on the outlook for that product, particularly after the NTAP proposal. Thanks.
Ivan Tornos :
Thank you, Steve, Ivan here. So lots of excitement as of late on Persona IQ. As of late, obviously, we got the NTAP indication that we're kicking October of 2023, were featured in the Wall Street Journal that got a lot of attention. We've signed additional contracts all over the U.S. with advancing rapidly in our limited market release, which as we said in the past, is more clinical in nature than commercial. We got now north of 500 million data points. And again, that's gained a lot of excitement. In terms of where we are, I'll tell you nothing has changed. We believe we'll be in a position to launch speed product by the end of 2023. We're working on four key things when it comes to this limited market release. Number two is understanding the clinical value proposition as well as the commercial value proposition. What do we do with all this data? What is the best way to position this product in the marketplace? Number two, as you can imagine, with the data component, there is a bit of a back and forth ownership, how do we utilize it, how do we make the best out of all this data. So we can act on it. And I would say with that tends a lot in this regard. Number three, is making sure that, overall, the customer experience is seamless. This involves patient education, this involves caregiver education. We're going to make sure that this is a best-in-class experience. And then number four, is how do we monetize the device. So in those four key areas, we've made tremendous advancements. And I do believe we're going to be in a position to launch at the end of the year. The NTAP is not going to impact every single patient, but it's a sizable amount of patients that are going to benefit from the additional reimbursement. And again, it's just another reminder that this is breakthrough technology, first to market, new to market that will make a difference. So the exigent is high, and we look forward to updating you guys down the road.
Steve Lichtman :
Thank you, Ivan.
Keri Mattox :
Thanks so much, Steve. Operator, can we go to the next question?
Operator:
We'll go next to Shagun Singh with RBC.
Shagun Singh :
Great, thank you so much for taking the question. And congratulations on a really strong print here. I guess just a question around guidance and Q2 trends. So your guidance is about 6% to 7% ex FX in 2023. Can you just walk us through expectations around cadence, perhaps shed some light on April trends for your business? How you expect that to stack up versus Q2. I think prior to the call, consensus was looking for sales and EPS of 1.79 and 1.77, respectively, your guidance obviously implies strength beyond Q1. So any color there? And then longer term, what does it mean for the growth profile for Zimmer going forward really versus consensus? I believe for 2024 is around 4.5%. So any color there would be great. Thanks so much.
Suketu Upadhyay :
Yea. Shagun, it's Suke. Thank you for the question. We definitely saw a very good quarter in the year in the first quarter, and we're expecting that momentum to carry through. And I think you would see that in our rest of year guide coming up to 6% to 7% ex FX. From a quarterly cadence standpoint, I would expect the overall growth rates in each quarter from here to step down from the first quarter. And it really goes back to that one that comp benefit I talked about in the first quarter on Steve's question, but also we have that day rate tailwind of about 100 basis points in the first quarter. So that you should think about, again, the first quarter being the highest fourth quarter being the second highest from a growth perspective and the second and third being a little bit lighter just based on tougher comps and a net day rate headwind. And so that's how you should think about cadence. But definitely, we're lifting our guidance by more than just the first quarter outperformance. We're actually pulling that momentum through the rest of the year as part of that raise. Maybe Bryan, do you want to talk about the underlying growth as we move forward.
Bryan Hanson :
I mean, we've stated it before. And obviously, just based on our performance today, our confidence level is even higher. We do believe that we're 4%-plus grower in a normal market. It's not exactly normal right now, as Suky talked about before, but our confidence continues to grow that we're in the right markets. We continue to build scale in more attractive submarkets and our confidence design.
Shagun Singh :
And just any color on April trends?
Suketu Upadhyay :
I would say, continue to support our increase in guidance. So things continue to -- our guidance initially showed or had an assumption of improvement throughout the year. Our current increase in guide assumes that as well in the early days in April continuing to prove that out.
Shagun Singh :
Thank you.
Keri Mattox :
Thanks, Shagun. Operator, can we go to the next question, please?
Operator:
We'll go next to Matt Taylor with Jefferies.
Matt Taylor :
Hey, guys. Can you hear me okay?
Keri Mattox :
We can.
Matt Taylor :
Great. So Suke, I want to ask you a question about margins. Because to your point, you're fortunate now you have this maybe excess growth. We don't know exactly. But that gives you a lot of margin to work with. And so I think, ultimately, that's what people care about is how our margin is going to progress. And I know you've talked a lot about it. But if you enjoy this excess growth for a while, how are you going to use that? Are you going to reinvest? Or are you going to let it drop through? What are you thinking about in terms of how to use the excess margin?
Suketu Upadhyay :
Yeah. I'd say the first thing is that it feels good to be in a position where you have the optionality, right, of deciding where you're going to put that additional growth in the margin or the profitability upside that comes from that. We continue to have a very strong, robust and innovative pipeline. We're going to continue to invest against the business in the right way, in a disciplined way. We're going to continue to be focused and make choices about, continue to expand in faster-growth submarkets that have good profitability profiles. We believe we can do that while still expanding margins over time. And that really comes from the strength and the discipline of the overall team in driving efficiency and mix shift in that investment profile to make sure that we're growing the top line while still growing the bottom line. So we think we can do both over time.
Matt Taylor :
Great. And one follow-up. So no one quite knows what's going to happen here, right? But it seems like there may be some excess demand for a while. And the best type of margin is that, that comes from excess organic growth, right? And so you may have that for a while. So how are you thinking about that? You talk about yourself as a 4% grower, but I mean clearly, you just outperformed that by a lot. And I guess, a, how long can that last? And then b, if it does last longer, then how does that change how you run the business?
Suketu Upadhyay :
Yeah. Just going back to your point there, remember the comp benefit in Q1 was a key driver beyond underpinning that large overperformance relative to sort of that 4% to 5% we've been talking about. So just want to make sure that we've got good clarity around that. Having said that, as Bryan talked about, we do think and have even more confidence now based on our execution, based on the normalization of markets based on our pipeline, that 4 to 5 is a durable number, and we'd be disappointed again if we weren't able to achieve that in normalized markets. So we think that, that's sustainable over time. And then as we talked about, if that provides profitability upside that can be reinvested back into the business while still driving margin expansion. I mean that's where we want to be, right? That was the story underpinning our margin expansion all the way back to the beginning a few years ago, which is to be able to do this through revenue leverage, and do it in a high-quality way while investing back to the business.
Matt Taylor :
Yeah, guys. Thank you.
Keri Mattox :
Thanks so much. Operator, can we have next question please?
Operator:
We'll take our next question from Vijay Kumar with Evercore ISI.
Vijay Kumar :
Thank you, guys. Congrats on really strong. I'll start here. My first one here, Bryan, there is some debate on perhaps demand being pulled forward here. Do you see this also in market growth as perhaps a catch-up of backlog as against a pull forward of demand and do you feel like with your product portfolio that you have, is Zimmer now gaining share in the market versus the industry?
Bryan Hanson :
Well, maybe I'll just quickly talk about what I see from a market standpoint, us versus market. And then maybe you could speak to, which I think when you say pull forward you talked about backlog consumption. So maybe you could talk about backlog. From us versus market perspective, it felt pretty good in the quarter. Obviously, we look at this on a year-over-year basis, a stack basis, a sequential basis versus our key competitors. But we try not to get overexuberant about any specific order or too depressed about any specific quarter. What we do look at, as I've always talked about, is an eight-quarter trend across those three vectors. If I go all the way back to Q2 of 2020, and I look at that consistent order trend, I feel very good about our position versus market. And I truly believe we're just getting started. So from us versus market perspective, I feel good, and I think it will only get better over time. If you think about the backlog, maybe you could speak to what we saw in the quarter.
Suketu Upadhyay :
Yeah. So there are a lot of factors inside the quarter that drove the outsized performance. I talked about year-over-year our original expectations, but we were above that, again, for a number of variables, including less pressure than we expected. We saw some backlog. I talked about, and we were able to navigate supply chain and good commercial execution. I would say backlog was probably the smaller component of the overall change our performance relative to expectations in Q1. We do expect that to continue for the rest of the year. That's built into our guidance as we move forward. And so yeah, it's good to have that a bit of an offset or tailwind relative to some of the other challenges we're seeing in the marketplace.
Vijay Kumar :
Understood. And Suky, one on margins for you. Gross margins up 100 basis points sequentially. Can you just remind us on what was the impact of inflation, China BP, et cetera, in Q1? And what drove this sequential gross margin expansion? And when I look at your guidance, revenue raised by 250 basis points at the midpoint, EPS up by 6%. Clearly, that implies operating margin expansion I think, north of 50 basis points. Is it all coming from gross margins versus operating leverage?
Suketu Upadhyay :
Yeah. So thanks for the question -- second question here, Vijay. The first thing is I'm just going to step back a little bit. As part of the overall margin expansion story, the Zimmer Biomet, we talked about ability to stabilize gross margins from '22 out for the next few years. Side of that on better revenue growth, we would leverage SG&A, which would give us the platform to then expand margins increase our earnings balance as a company. So that continues to be the strategy and story, and I think you're just seeing that play out here to 2023. Remember, as we came into '23, we talked about 100 basis points roughly of inflationary pressure in '22. That was going to capitalize in our P&L this year. That still remains true. In fact, probably seeing a little bit of additional incremental pressure on some areas of supply chain and inflation. I talked about contract manufacturing supply prices. We're still doing some spot buys for certain raw materials. It's putting a modest amount of incremental pressure. Nothing significant, but something we just want to keep our eyes on for the rest of this year and into 2024. But again, inflation has largely stabilized. So that 100 basis points is definitely coming in year-over-year. But despite that, we said that 22% on gross margins would be relatively in line, excuse me, '23 versus 2022, right? So the teams are going to be able to find a way to offset that incremental headwind and we've largely done that. Now in the first quarter, we did see exceptional growth sequentially, but also year-over-year. There are a number of variables that drive that. But I'd say the three biggest are around volume gains, right, that led us year-over-year but also versus expectation. Saw some FX hedge gains in the quarter and also a pretty pronounced mix benefit, especially given the outsized performance of our large joints versus our S.E.T. and other category and also U.S. versus the rest of the world. So those are kind of the three dynamics that are going on. In the first quarter, we -- as we go through the rest of the year, we still expect those three variables to play a positive impact, but not at the same level, okay? So the way to think about this is gross margin for the rest of the year will step down versus Q1, but still for the overall year will be higher than it was in 2022. So you should think about it on an underlying basis, '23 being still in line with 2022, okay? So gross margin is definitely a tailwind, underlying still consistent with prior year. The operating margin that you're implying off of our EPS guide is I think the directionally right way to think about that, and that upside is coming primarily from gross margin. So those are some of the building blocks that underpin our EPS raise for the year.
Keri Mattox :
Operator, can we have the next question?
Operator:
We'll take our next question from Robbie Marcus with JPMorgan.
Robbie Marcus :
Great. Thanks for the question, and congrats on a nice quarter. Maybe to start, I was hoping maybe you could dive into some of the drivers behind the knee growth rate. It was really impressive, definitely better than market growth and was just hoping you could help us understand how much is coming from robotics, from mix of new products and really dive into some of the growth drivers there? Thanks.
Ivan Tornos :
Hey. Thank you, Robbie. Good talking to you this morning. I will probably bucket the performance in two key areas
Robbie Marcus :
Really helpful. And maybe for Bryan and Suke, we've heard you talk in the past about using M&A to maybe diversify into faster-growing parts of the market. There's a lot of talk from your competitors about M&A, some of them more specific than others. I thought it would be great to just get your latest thoughts on M&A for Zimmer, how you're thinking about it in terms of size and ability to diversify away from your core markets and your thoughts on valuations out there right now. Thanks.
Bryan Hanson :
Yeah. So maybe just quickly before I get into our focus areas. I'd say in valuations, I still think -- see things as being pretty expensive. I look at assets that are out there today. We're not seeing as much downward pressure on valuations as we certainly were hoping for. Maybe a little better recently, but not as good as we would have expected. And then that, combined with the fact that capital is a little more expensive to come by is not necessarily a great combination. That said, we still think there's opportunities that we're going to try to pursue. We are absolutely in Phase 3 of the transformation. As we said many times, Phase 3 is focused on portfolio transformation using capital to be able to acquire technologies that are attractive to the organization. And we're very focused on this and extremely disciplined, number one, we're not going to look at a target if it's not mission centric. That's very important to the organization. We are a mission-driven organization, and that target needs to move our mission forward. We need to see a path to leadership at some point if we move into that space or we're already in that space. We need to see a WAM accretion, so increasing our weighted average market growth and as a result of that, our revenue growth and then ultimately helping us drive faster EPS growth. So those are the types of deals. And then inside of that, we're looking at enhancing our position through acquisitions in fast growth subcategories of recon, which may not seem super exciting, but the fact is there's some fast growth subcategories that we want to build scale in so that we can grow faster than the overall market in a consistent way. And then we're also going to look to diversify. So looking at acquisitions, which we've already shown in other parts of orthopedics that are faster growth, that's mainly in our set category for us. Eventually looking to diversify outside of orthopedics to diversify outside of electric procedures and give us other forms of opportunity to grow the business again outside of orthopedics. And we would say most likely in the near term, we would look at smaller to midsized deals, and we would kind of quantify that to say about $1 billion in revenue or less would put us in that category. And we would probably stay a little closer to the vest in Orthopedics in the near term. So that's the way we're thinking about it right now. Anything else you want to add to that?
Suketu Upadhyay :
I would just say all the hard work that the team has done in improving financial performance, paying down debt over the last few years, even through a challenging period to COVID. We've really strengthened the balance sheet. And so the great thing is our capital structure can support everything that Bryan spoke about. Right now, we're traveling somewhere around the mid- to high-2s from a net debt to leverage ratio perspective. So if you took turn, turn and half on that relative to $2 billion to $2.5 billion of adjusted EBITDA, you would see that there's a substantial amount of M&A firepower available to us. And those numbers would only be augmented by the EBITDA from a target. So a long way of saying that we've got the capital structure, we've got the balance sheet to support what Bryan talked about.
Bryan Hanson :
And what's key about that, we were very disciplined about this. It's who we put phases into the organization transformation. We wanted to make sure that the base business was humming. That the organization was executing just like Ivan spoke to, we have. Our confidence level is very high. So not only do we have the balance sheet to move into that Phase 3 transformation. We now are ready to do it. We have the capability. We have the right team in place and we have the execution of the base business. So we're excited about Phase 3.
Robbie Marcus :
Thanks for the question.
Keri Mattox :
Yeah. Operator, can we get the next question in the queue.
Operator:
We'll go next to Matthew O'Brien with Piper Sandler.
Matthew O'Brien :
Thanks for taking the question. Brian and Ivan, you talked a lot about new product introductions. And I think you said 40 through the next three years. How does that compare to the number of products you've introduced over the past three years? And then I know you've got your competitors listening probably don't want to give us too much. But just can you give us a general sense of where those are going to go? Are they going to go into set specifically? And are you going to start touching maybe some areas kind of outside your traditional power alleys, I guess, with those new product introductions.
Ivan Tornos :
Yeah, thanks for your question, Matthew. So first things first, it's not just the quantity, it's also the quality. Not every new product is created equal. But I think we referenced in the past, we launched around 50 new products from 18 through 22. And the commitment is to do at least 40 new product launches over the next 36 months. And again, what excites me about this launch is, Matthew, is the type of products that they are. They're differentiated. In many instances, they are first to market. And most of them are in growth areas that are going to drive WinGuard accretion for that, so 4% or above. In terms of where they're going, it will take me about an hour to go through everything in the pipeline. I'll keep it to maybe three minutes or less, but I'll tell you excited about where we are in is with a full portfolio, things that are already -- we already spoke about cementless or Persona OsseoTi new to market as of two-three months ago is getting up on traction. Our cementless penetration is at 15%, 1-5. We deserve to be in the 50% range, and that is definitely the goal. Excited about ROSA partial or robotic parcel system that is next generation is getting relaunched summer of 2023.Persona IQ, I think, we spoke plenty about that. As you look at the next 12 to 14 months, we will have Oxford Partial cementless here in the U.S. That is a legacy product that has gained a ton of markets in Europe. Persona Revision I didn't comment on that one, Robbie asked about performance. In Q1 Persona Revision saw tremendous growth again. That is a product that is only available in the U.S. I can hardly wait for 2024 when it gets into all U.S. markets. Shifting to hips, we launched ROSA Hip on the direct interior category, posterior to come at some point. In the market, we are the only mixed reality company with hip insights. That is something that is gaining tremendous traction. You can see the hologram of a patient anatomy. It drives efficiency and accuracy in a case with a lower instrumentation. Bryan, in the opening remarks spoke about HAMR or surgical impact. That is also a device that is driving efficiency in an operating room, frankly, taking an existing product. Product that is in market and making it better. It drives variable energy control. It's got better accuracy. It has the ability of actual implanting the cap. Again, I can spend an hour in that regard. On [Indiscernible], we got a sizeable of products inset through acquisitions and organic. We recently announced that we closed the Embody deal. That is giving us a competitive advantage in soft tissue repair, whether it's tendon injury or whether it's rotator cap that is performing very well. We got everything that we need in Sports medtech. We have a new product introduction in Shoulder. Again, I think three minutes are almost done, but I will tell you, there is a lot that is happening and it's happening both from an implant standpoint happening from a technology data solutions standpoint. So we look forward to updating you at an upcoming product fair, but I will tell you, innovation is truly now a competitive advance seat at Zimmer Biomet.
Matthew O'Brien :
Thank you can hear the enthusiasm there. I appreciate it. A question for Suke. On the pricing side, I think you said down 140 bps in Q1. You had a competitor report last night, and they said more like neutral this year, they're more diversified. I know it's a little different. But are you guys a little bit more on the stream side as far as pricing concessions at this point in the marketplace? Is that part of the strategy? And can pricing actually be a little less of a headwind for you guys over the next maybe year or two versus what you've seen historically? Thanks.
Suketu Upadhyay :
Yeah. Hey, Matt, so I definitely think that pricing will be less of a headwind than we've seen historically. I do think that pricing pressure in the overall market will remain it could potentially intensify over time. But I will tell you, our performance, so idiosyncratic to Zimmer Biomet is that we're putting things in place to ensure that we don't have pricing erosion at the same level that we've had historically. Even if the market worsens. So we think that we can continue to travel less than 200 basis points here in 2023 and at least for the near term beyond that.
Keri Mattox :
Thanks, Matt. Can we go to the next question, please?
Operator:
We'll take our next question from Joanne Wuensch with Citi.
Joanne Wuensch :
Good morning. And very nice quarter. Just summing back just a little bit. I don't think anyone expects these kind of growth rates to go on forever that it's a new normal. But it does give you what I would call, breathability to make some strategic decisions as you get these really strong quarters on a cash flow basis and on a revenue basis. What changes and maybe the way you approach your strategy given it?
Bryan Hanson :
Yeah. Probably no major change, to be honest. To your point, it will create some headroom and it gives us that optionality as referenced before to let it flow through, which, as you can tell by our guide, we're going to let some of this flow through, but also to invest, and we are highly focused on driving revenue growth. We've done a lot of research in the med tech space. And it's very clear that those companies that are consistently top quartile performers in TSR, grow faster than those companies that aren't. And the second leading thing behind that is EPS growth. So make no mistake, when we get this headroom, we're going to be focused, first and foremost, on investing in the business to continue to drive sustained revenue growth that ultimately as a result of that drives EPS growth as well. So it's going to be the balance that we've always had with maybe a little more optionality than we would have otherwise.
Joanne Wuensch :
And then as my follow-up. You did mention that there are some, we'll call it, niggling supply chain issues that are out there. Is there a way to put some color around that, what those issues may be? Are they easing? Or are they staying the same, intensifying -- and just sort of maybe give us a line of sight on what would make those go away.
Ivan Tornos :
Absolutely. I wish I will tell you when they are going to go away. What I will say is that we're navigating those very effectively. There are three key areas that I would say, account for 90% of the problem
Bryan Hanson :
Yeah. The other factor that's impacting it is you've got all these negative pressures that Ivan just referenced. And then, of course, our demand is going up pretty substantially. So the demand signal is coming in much higher than we expected in the face of that environment that's pretty challenging. And I just want to -- again, I know I said it in my prepared remarks, but I want to compliment the team. I've been with the commercial teams around the globe. And they're just doing an excellent job. These guys are really fighting 24 hours a day to make sure that we get product to the cases where they're needed. And trust me, it's a lot of work. It's a lot of effort. It's a lot of frustration I'm positive of that, but the team is doing a wonderful job indeed.
Joanne Wuensch :
Bryan, thanks for the question.
Operator:
We'll take our next question from Lawrence Biegelsen with Wells Fargo.
Lawrence Biegelsen :
Good morning, guys. I'll echo my congratulations. A really nice quarter here. Just one for Ivan person, one big picture, one for Bryan. So Ivan, on Persona IQ, can you put the NTAP into context for us into context for us, what percent of knee patients are Medicare. What do you see happening with reimbursement for commercial payers? Do you expect them to follow? And have you guys filed for a pass-through payment in the outpatient setting? And I had one follow-up for Bryan.
Ivan Tornos :
Thank you. I'll keep it short, so you can continue with Bryan. But first things first, NTAP. New technology add-on payment enables an additional payment of around $850 per additional knee, so up to $1,700 for both knees. The decision kicks in, in October or actually the indication. The approval kicks in, in October '23 and the last for 30 years. So it's pretty material. In terms of -- and by the way, it's not done. So we're going to be requesting these additional payments for the base station and other components. So there may be some additional upside to these numbers that I just quoted. In terms of the percentage of patients, this is for Medicare inpatient. We estimate that to be between 15% to 20%. Relative to the second part of the question, do we think that commercial payers will follow. I think that comes down to the data to the clinical data. As we expand the number of patients that benefit from this technology, we're able to validate the clinical claims that we think that we're going to able to validate, of course, this will become a new standard of care, and this will impact not just Medicare patients, but also commercial patients. So I think you had a follow-up question for Bryan.
Lawrence Biegelsen :
And just Ivan, on the outpatient setting, did you file for pass-through payment?
Ivan Tornos :
We're in the process of evaluating that, but we have not done that as of right now, no, we don't have any.
Lawrence Biegelsen :
Okay. And Bryan, people have asked this question. I'm going to ask a similar question in a different way. So the recon market is clearly running hot now, 13% by our math in Q1. Pre-COVID, the recon market grew 2% to 3%. So a, do you expect the recon market to eventually return to its historical growth rate at some point in the future? I'm not asking you for a date. And b, does that create more urgency for you to do some M&A to increase your [Indiscernible] and diversify while things are good. Thanks for taking the question.
Bryan Hanson :
Yeah. I think it's important to go back to the first quarter and just say, hey, that's not indicative of recon market. That is an easy comp for everybody, not just us, but across the board. So you have to look at that outsized performance and kind of haircut it by the comp. But even without that, it's a very hot market, to your point right now. And there are certain things about that, that you might think would be for just a period of time. Backlog recovery should be here for a while. But that will eventually go away. But there are some things associated with Recon that we think are sustainable. And we've talked about these in the past. I don't know that everybody connects with what we're saying. But here's what I see. If I think about market in total, there's a pretty significant technology shift that's occurring in Orthopedics at a very rapid pace. And by the way, we're just really getting started with that technology shift. That has a mixed benefit associated with it. So you don't need one new patient. You just need that technology to come in and that lifts the overall market growth and creates because of the innovation, better pricing stability. So the combination of those two things, in my view, is durable and sustainable to elevate the overall recon market growth, and we're certainly going to take advantage of that. The other benefit that we have in this area for us specifically is that we're investing very disciplined in areas in recon that are faster growth. So our weighted average market growth will be better than the overall market growth in Recon. That creates more sustainability for fast growth and above-market growth for the company. And then outside of that and specific to us, as Suky said, we're doing a much better job on pricing. And that's a big benefit. So if we can stay below our historical average in pricing that does also elevate our Recon business. And then finally, if I think about our innovation, we do believe it's differentiated. So we have an opportunity to also take market share through that innovation. So we really do believe Recon is attractive and sustainable. It's not going to be first quarter type of growth. That's abnormal because of the comp. But we do believe it could be elevated. We're also looking into some patient behavior potential changes that we're seeing through COVID. This is early days. We're kind of analyzing it right now, but the feedback is that there's really three things that may be changing the perspective of a patient on whether they do or don't get a procedure. Which would be positive for us because we think that we're going to make the decision to get the procedure. The first one is the technology advancements are giving people confidence that the outcome of the procedure is going to be good. A lot of people don't get the procedure because they're afraid the procedure is not going to do what they wanted to do. If that fear goes away, you may see more people enter the funnel. The second is that you're getting out of the hospital or the ASC faster. So that turnaround for the procedures 24 hours a lot of times used to be dates. So that also then is less inconvenient for the patient. And then the ASC setting by itself is attractive. I mean we don't want to go to a hospital to get a knee procedure where a bunch of sick people are. The ASC setting is less overwhelming, feel safer. And I think people are more attracted to it. And the final thing is you've got flexwork right now. That's pretty rampant out there. And so people feel more comfortable, more confident rehabbing and also staying in work. So we think those three things really have the opportunity to continue to elevate the recon market. And we're going to continue to look at it and take advantage of it.
Lawrence Biegelsen :
Thank you.
Keri Mattox :
Thanks, Larry. I think we have time for one more question in the queue.
Operator:
We'll take our next question from Travis Steed with Bank of America.
Travis Steed :
Hi, thanks for taking questions. I guess I hear you on all the strong momentum to carry through post Q1 and improvement throughout the year. And so maybe given the funky comps on Q1. Maybe think about Q2 in dollars, like hips and knees before the pandemic were typically flat to slightly down. And so I don't know if you think on a dollar basis, Q2 hips and needs would still be flat or if it can actually go up sequentially. Just kind of thinking about the momentum you have going through the year?
Suketu Upadhyay :
Yeah. I think on an absolute dollar standpoint, you should expect to see a step down in Q2. That's typical seasonality. So growth rates yet are going to be wonky sequentially or year-over-year between 1Q and 2Q, but you should expect to see the traditional sort of historic step down in absolute dollars for Q2.
Travis Steed :
Okay. Appreciate that clarity. And then I did want some clarification. I think I heard you say gross margin for the full year would still be flat year-over-year. I wanted to make sure I understood why it was still flat every year given the momentum on Q1. And then it looks like you bought back $268 million of stock in the quarter. I don't know if there was any color on that, if that's kind of a new use of capital for you. Thank you.
Suketu Upadhyay :
Yeah, thank you. Thanks for the question on gross margin, Travis, because actually, I intended to say that gross margin would be higher this year versus 2022, primarily driven by that mix component and FX hedge gains. But if you thought about neutralizing those because they may not continue beyond 2023 at the same level, the underlying gross margin will be equivalent to 22%. But in absolute terms, it will be higher this year versus last year on gross margin. I just want to make sure that's clear. Very perceptive on the share buyback. We did buy back, I think, about $250 million of shares this year, $150 million in Q4 of last year. That gets split between the Embody transaction, where we structured that with some equity to be advantageous from a deal structuring standpoint. So we bought those shares back, so to avoid any dilution on that deal from shares. And then the second is our more normal cadence going forward will be to buy back equity dilution from annual brands.
Travis Steed :
Perfect, thanks so much.
Keri Mattox:
Thanks so much for the question. Yeah. And I think that wraps us up through the queue, and we're at 9:30. So thanks, everyone, for your comments and your questions. The IR team is obviously available today, and we'll continue the conversations as we go through the day. Please feel free to reach out with any others.
Operator:
Thank you again for participating on in today's conference call. You may now disconnect.
Operator:
Good morning ladies and gentlemen and welcome to the Zimmer Biomet fourth quarter 2022 earnings conference call. If anyone needs assistance at any time during the conference, please press the star followed by the zero. As a reminder, this conference is being recorded today, February 3, 2023. Following today’s presentation, there will be a question and answer session. At this time, all participants are in a listen-only mode. If you have a question, please press the star followed by the one on your pushbutton phone. I would now like to turn the conference over to Keri Mattox, Senior Vice President, Chief Communications and Administration Officer. Please go ahead.
Keri Mattox:
Thank you Operator and good morning everyone. I hope you are all well and safe. Welcome to Zimmer Biomet’s fourth quarter 2022 conference call. Joining me today are Bryan Hanson, our Chairman, President and CEO; EVP and CFO, Suke Upadhyay, and COO Ivan Tornos. Before we get started, I’d like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by the forward-looking statements due to a variety of risks and uncertainties. Please note we assume no obligation to update these forward-looking statements even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties in addition to the inherent limitations of such forward-looking statements. Additionally, the discussions on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within our Q4 earnings release, which can be found on our website, zimmerbiomet.com. With that, I’ll turn the call over to Bryan. Bryan?
Bryan Hanson:
All right, great. Thanks Keri, and thanks to all of you for joining us this morning for the call. We’ve really got three sections for the call this morning. First, I’m going to talk briefly about our fourth quarter performance and spend a few minutes on our teams, what I just define as solid execution, as well as our innovation and drivers for continued strong performance. Then for the second section, as usual, Suke will provide more detail on the quarter itself and very importantly our 2023 guidance and expectations. Then of course, we’ll close things out by addressing any questions that you might have. Before we get started, I wanted to take a minute to thank really the ZB team, just the full ZB team not only for their work in making Q4 another successful quarter but also for their resilience. The innovative thinking and dedication to getting the job done throughout all of 2022, even in the face of very real adversity, there’s no doubt in my mind that this team is the engine that is driving us forward, so again thank you. I can tell you that I’m very proud to be on this journey with you. Now as we turn to Q4 results, know that each and every one of you made the quarter happen, and I can tell you it was a solid quarter. We again saw better than expected growth driven by continued procedure recovery, strong execution, and a solid momentum with our new innovation, and as expected, we also benefited from some favorable comps in the quarter. Inside of this, we saw another positive quarter of year-over-year momentum in large joints with our overall global hip and knee business growing more than 8% and 10% on an ex-FX basis, and our overall set category grew in the high single digits driven by strong performance in our business growth drivers, which as we said before, are supports, CMFT, and upper extremities, as well as the expected tailwind from BBP comps in our trauma business. That said, we are clearly seeing overall market stabilization, but our fourth quarter execution and procedure recovery is still set against a macro backdrop that is challenging and fluid. Foreign currency has improved but remains a challenge and supply, inflation and staffing pressures continue. In fourth quarter, our team was once again able to navigate these challenges, flexing what I would just define as a muscle memory that I think, fortunately or unfortunately, is a bit unique to ZB and has served us well over the past year during 2022. But make no mistake - the challenges are real and they’re ongoing, but regardless of this environment with COVID mainly in the rear view mirror, I have confidence that the ZB team will continue to deliver. Our culture, our strategy, innovation and execution are coalescing right now, driving tangible momentum and importantly belief from the team, and as a result confidence in our business continues to grow. Let me just give a few examples from Q4. In the quarter, we announced the approval of our new cementless knee form factor which is adding to our Persona family and strategically rounding out that portfolio. The first procedures have been completed with this new keel design, and the feedback, as expected, has been very positive. We continue to belief that our cementless knee penetration will grow significantly and that this differentiated, premium product can really accelerate that growth. It’s early days with full launch planned for the middle of the year, but make no mistake, this is a real growth driver for our knee franchise. This launch builds on other recent product launches, like hip insights and our Identity shoulder system introductions, bringing now our total to more than 50 new product launches from 2018 through 2022, and importantly the largest majority of these launches came in markets we see growing in the mid single digits or better. That’s really important, being launched in markets that we see growing in the mid single digits or better. This strategic prioritization and output from our innovation pipeline has helped ZB more than double our vitality index over that time, and very importantly increase our revenue in faster growth markets and sub-markets, which of course drives positive increases in our weighted average market growth. That momentum continues. We expect to launch another 40-plus products between now and the end of 2025, once again with the majority of those launches in 4%-plus growth markets. This will drive further increases in our vitality index and weighted average market growth, and most importantly bring real and meaningful innovation to the patients and customers that we serve. So what I know for sure is that our current momentum, very robust new product pipeline, and our strengthening balance sheet focused on accelerating our portfolio transformation positions ZB well for the future, and as a result, I feel increasingly confident about ZB’s ability to transform our business, drive growth, deliver value, and achieve our mission to alleviate pain and improve the quality of life for people around the world. With that, I’ll turn the call over to Suke for a closer look at Q4 and again our expectations for 2023. Suke?
Suketu Upadhyay:
Thanks and good morning everyone. For today’s call, I’m going to focus on three topics
Keri Mattox:
Thanks Suke. Before we start the Q&A session, just a quick reminder to please limit yourself to a single question and one follow-up so that we can get through as many questions as possible during the call. With that, Operator, may we have the first question, please?
Operator:
[Operator instructions] Thank you. We’ll go to Ryan Zimmerman with BTIG.
Ryan Zimmerman:
All right, can you hear me okay?
Bryan Hanson:
Yes, we can hear you.
Ryan Zimmerman:
All right, good morning. Thanks for taking the questions, Bryan and Suke. Bryan, maybe starting with guidance, if I think back to third quarter, you were asked whether 4% organic growth was an appropriate way to think about ’23, and at the time you said ’23--you know, you didn’t see ’23 as normal. But then in January, you said we’re in a better place, procedures are kind of normal and we’d expect that to continue in ’23. So as we sit here today with guidance at, you know, 4% constant currency at the midpoint, just help us understand kind of that shift that’s occurred in the fourth quarter that gives you a more optimistic view of the year ahead. Really, the key to my question is, this 4%, do you view that as a floor, do you view that as realistic or aspirational, and just help us kind of characterize where you’re sitting in guidance and the year ahead.
Bryan Hanson:
Got it, thanks for the question, Ryan. Maybe what I’ll do is, Suke, you could provide color around the way we’re thinking about guidance, because there’s a lot that goes into it. We still don’t believe it’s a normal year, obviously - there’s a lot of puts and takes on either side of the equation, but you could walk through those, perhaps, and then I will give you some color around what we’re seeing so far in January and how that’s making us feel as well. But why don’t you go ahead and start?
Suketu Upadhyay:
Yes, so Ryan, thank you for the question. Good to be with everyone. First of all, I’d say we had a really good close to the year. We ended top line, bottom line, and free cash flow at the top end of our third quarter guidance, so a really strong finish. There was a number of variables behind that, but the key one is really about execution, so feel really good about the momentum that we have. As we move into 2023, some of the key variables that underpin our guidance, I talked a little bit about them on our--in the scripted remarks. The first is around stabilization related to case cancellations, staffing shortages and things of that nature. We expect that to continue to improve throughout 2023. We’re not completely at normal markets - there are still some underlying dynamics impacting the overall market, but things are definitely improving and we expect that to continue to work through the rest of this year, so procedure recovery for sure in ’23. The other thing we have to think, though, to balance that out is we’re continuing to see supply challenges. We saw those in the fourth quarter. Our supply chain team as well as our commercial teams responded incredibly well to those challenges, but we’re assuming that those supply challenges remain at least through the first half of this year and begin to improve in the second part of this year. But as we put all that together, we’ve got a lot of confidence against our full guidance range. We’re optimistic about where trends are going and, like I said, we’re really excited about where the business is headed. I don’t know, Bryan, if you want to talk a little bit about what we’re seeing so far?
Bryan Hanson:
Yes, clearly a lot of variables that are still moving, but if I just think about kind of the here and now and just look at what we’ve already accomplished in January, I’d just say it was a really strong start to the year. Again, we’re still looking at those variables, but when I think about the things that we can control, things around execution or innovation, they’re going in the direction we want. When I think about the things we can’t control, it’s procedural recovery and supply challenges. Those are also coalescing in a nice way, so I guess suffice to say based on those things, the momentum right now, and it’s early days, but the momentum right now in 2023 is feeling really good. Again, we’ll continue to monitor those other variables, but we feel pretty good about how we’re starting.
Ryan Zimmerman:
Very helpful. Then if I could ask a follow-up, Suke, the street’s margin expectations going into today for operating margins were essentially flat, maybe up 10 basis points, so really in line with your guidance. But just maybe walk us through the levers that you think are at your disposal here on the operating margin line that could maybe move that up a little bit higher than where we’re starting today.
Suketu Upadhyay:
Yes, I think one of the key drivers is obviously going to be revenue growth, right, so if we continue to navigate the challenges around supply as we have been and as we saw in the fourth quarter, if we continue to see stabilization in the market and start to trend towards the upper half of the range, clearly that will help drive some margin expansion as we continue to leverage our overall cost base. Beyond that, it’s just the normal block and tackling that this company has gotten accustomed to over the last four or five years. We’re going to continue to drive sourcing improvements around site optimization, six sigma procurement. I’ll tell you, the commercial team has really stepped up. I’ve never seen a focus on mix, on simplification of the supply chain and SKU rationalization, on pricing before in the company’s history, so I think we’ve made really good strides from a commercial perspective, which I think could be some leverage to the potential upside. Then across SG&A, we’re still in the early innings of fully leveraging our shared service operating model, which we started through the pandemic, so I think we have a number of things at our disposal that can help either expand margins or de-risk our margin aspirations in a downturn, so feeling really good about what the overall team has been able to accomplish and where we can go with this.
Keri Mattox:
Ryan, thanks so much for the questions. Katie, can we go to the next one in the queue?
Operator:
We’ll go next to Mike Matson with Needham.
Mike Matson:
Yes, good morning. Thanks for taking my questions. I guess I’ll start with the recon market. It looks like it grew about 8% in 2022, and this is well above the 3% to 4% that we were seeing prior to COVID. What do you think is driving this above-normal growth? It seems like it’s got to be the COVID backlog, because I don’t think pricing has been all that strong, but maybe you could comment on that, and do you think that this type of high single digit market growth can carry into 2023?
Bryan Hanson:
Yes, so I would say that probably the biggest reason that you’re seeing that outsized growth overall, I wouldn’t define it as backlog consumption. I don’t believe we’ve started to consume the backlog. I would define it more as comps, we just had easier comps. I’d maybe call that procedure recovery versus the prior year, so that to me is not something that’s necessarily sustainable but it was just easier comps, being that we had more pressure last year. Pricing was better, though, across the board, whether it’s our company or other companies. We did a better job in pricing as a group and as a result of that, that buoyed us as well. Suke’s talked before about what our expectations are in pricing as we move into 2023, but I’m sure we’ll get another question around that, so those are probably the two biggest things that wouldn’t be as sustainable. But make no mistake, I feel like the market is strong, and some of the things that we look to that can buoy sustainably the market growth is innovation, and innovation adoption right now in orthopedics is really promising, not just the typical innovation but technology innovation that absolutely can drive the share of wallet or mix benefit you get with that new innovation.
Mike Matson:
Great, thank you.
Operator:
We’ll take our next question from Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
Good morning, thanks for taking the question. Congrats on a nice finish to the year here. Suke, FX of negative 1.5%, can you tell us the rate you’re using - that seems a little high, and the EPS flow-through?
Suketu Upadhyay:
Yes, sure Larry. Good to be with you today. You’re right - we pegged FX as a headwind year-over-year at 150 basis points. That’s an improvement from our original commentary back on our third quarter call. Originally, we were thinking 300 basis points, and so we did see some moderation of the dollar at the very back end of 2022 and early part of ’23, so that drove the improvement. The way to think about it is we use recent rates. We look at the full cadre of all of our currency exposures. One of the things to recall, remember that about 40% of our revenue is foreign currency exposed. Half of that is euro and yen, right, so the other half is a lot of other currencies that you have to take into consideration. When we aggregate all that, we’re at 150 basis points. Hopefully we continue to see things improve throughout this year and things turn favorable, but for right now, that’s our latest estimate. The flow-through on that, we expect it to be about 20% to 30% down to earnings. That’s a little bit less than what we said last year, and as I said last year when we quoted 30%, there are a lot of variables that can affect that but it’s still a reasonable drop-through to historical norms. So again, 150 basis points based on recent rates, euro, yen making up about half of our foreign currency exposure, and the flow-through being about 20% to 30%.
Larry Biegelsen:
That’s helpful, and then on SET, it was about 2% in 2022. Can you help us think about the growth that’s embedded in the 4% constant currency at the midpoint and how you’re thinking about the different sub-segments there? Thanks for taking the question.
Bryan Hanson:
Yes, so if we think about overall SET, I think what you’re asking, Larry, is how we view that business in an undisturbed market going forward. Is that kind of what you’re asking?
Larry Biegelsen:
Yes, and certainly for ’23, Bryan.
Bryan Hanson:
Yes, so when we come into 2023, even though it’s not going to be a normal market, we’re still thinking about SET as being able to be a mid single digit grower. That’s the way we’re looking at that. In an undisturbed market, we would think the same thing. Remember in the first half, though, we’re going to be a bit pressured still by the restorative therapies group and that change in reimbursement, but even with that throughout the year, we believe that that segment can grow in the mid single digits. The key drivers for that, because we don’t treat all the businesses the same from an investment standpoint, will be our growth drivers, which would be upper extremities for us, our sports business, and in certain portions of our CMFT business.
Larry Biegelsen:
Thank you.
Keri Mattox:
Thanks Larry. Katie, could we go to the next question in the queue?
Operator:
We’ll go next to Travis Steed with Bank of America.
Travis Steed:
Hi, good morning, and congrats on a nice quarter. I wanted to ask about the robotic shoulder opportunity. I think before you’d said you’d be first or second to market. Now that Stryker has given more definitive timelines, I wonder if you can kind of clarify if you’ll be first or second, or some timing there, and how you’re thinking about the opportunity from a mix and share perspective.
Ivan Tornos:
Hey Travis, good morning - Ivan here. I don’t know where they are, we don’t pay attention to where competitors are. We pay attention to where we are in the process. I’ll tell you frankly, I’ll be very surprised if we’re not first to market, given where we are in the development cycle. My expectation remains that we’re going to be ahead. The most important part is not just the speed in the actual launch, it’s the quality, the features and benefits that we have in the platform. Given the mix of developers that we have involved in the project, I do think it’s going to be transformational for our platform, so that would be my answer.
Travis Steed:
Okay, and then--that’s fair, and then a quick clarification. On the 3% to 5% constant currency growth, how much of the revenue is coming from Embody in that? Then Bryan, a question for you on M&A. Just kind of curious what your willingness is in 2023 now that markets are a little more diversified beyond electives, or if 2023 is more of a tuck-in year from an M&A perspective. Thank you.
Bryan Hanson:
Sure. Maybe I’ll just start with the Embody thing. That’s a relatively small acquisition. I would probably think more about that as a product launch, so it’s not overly material but it’s a very attractive subspace of sports. As we’re building our that commercial channel, it’s one of those things you really need in your bag to attract talent to that commercial channel, so it’s important to us but I wouldn’t look at that as a significant or a material impact to the year, only in the sense that we’re going to be able to bring that channel in place and get good momentum in sports overall. From an M&A standpoint, yes, we are clearly in Phase 3 of the transformation of the company, which I’ve clearly talked about looks at portfolio transformation, focused on getting more revenue in faster growth markets in its simplest form, and that’s exactly what we’re going to concentrate on. The fact is as our balance sheet continues to strengthen, our flexibility here, strategic flexibility goes up, and we will look at acquiring technologies that make sense from a mission standpoint for the company, that we see a path to leadership in, that we think will increase our weighted average market growth because that’s important for sustainability, and we see a path to be able to increase growth rate and EPS. I’ve said before there are three areas that we’ll look at for acquisitions, mainly kind of smaller to midsized deals, but we’d look at things that would enhance our position in recon in those faster growth sub-markets - that could be robotics, data, or the ASC setting. In orthopedic area diversification, that would be in faster growth sub-segments like sports or CMFT or extremities, and then as you said, those things that might be outside of orthopedics that would help us diversify the business away from elective procedures but also in fast growth markets. All of those things are on the table right now, and again as our balance sheet strengthens, our ability to action that obviously also increases. We’re going to stay disciplined, there’s no question about it, but we are clearly on the hunt for targets that make sense in those ways.
Travis Steed:
Great, thanks for the color.
Keri Mattox:
Thanks for the question, Travis. Katie, we can go to the next question in the queue.
Operator:
We’ll go next to Drew Ranieri with Morgan Stanley.
Drew Ranieri:
Hi, good morning Bryan and Suke. Thanks for taking the question. Maybe Bryan, just to start, a question for you. You’ve talked about your confidence in the business, and I understand that your thinking is this year’s not normal relative to pre-pandemic times, but it’s been a while since you last discussed long term plans. I’m just curious how you’re thinking about the business longer term and your confidence in gross margin expansion opportunities ahead. Just anything that you could help frame investors with in terms of thinking about the business from a margin or growth perspective.
Bryan Hanson:
Yes, so maybe I’ll start, and Suke, I’ll pass it to you on the margin side. I would say our team’s confidence is as high as it’s ever been, quite frankly. Just think about that in the short term - it is not a normal environment. There are a lot of challenges that we’re having to deal with from a supply chain standpoint. But I do go back to what I said in the prepared remarks - I have a lot of confidence in this team because of the muscle memory we have over the last five years of dealing with a lot of adversity. So just in this moment of a non-normal environment, I would rather have this team than any other team because I believe they can fight through those challenges, and they’ve proven it. That’s number one. Number two, outside of those challenges, we’re just hitting our stride. From a momentum standpoint, we’ve had a lot of kickoff meetings here recently - I love to go to those meetings. You get a real sense for how people are feeling, just having a conversation with sales reps, that’s where it all starts. The momentum there, the confidence there, the belief there is as good as I’ve ever seen it, so all those things add up to me to say, particularly in a normal environment, we’re in a good place and I feel confident that we can continue to deliver the innovation and drive real revenue growth. I don’t want to give too many views of what the future revenue growth of the company will be, but know this - as we increase the weighted average market growth of the company, as we get to a 4% that’s organic that we can commit to and sustain, that won’t be good enough. We’ll continue to look at portfolio transformation to drive it north of that, but right now I feel really good. I feel really good about the confidence that the team has and I feel really confident about the team’s ability to drive the results that we just guided to in 2023. Maybe you want to talk more about the margin expansion?
Suketu Upadhyay:
Yes, I’ll actually level up from margin expansion and talk a bit more about how we think about it, which is earnings power inside the company. Our goal is to drive a leveraged P&L, right, and what do I mean by that? We’re looking for earnings growing faster than revenue, and as we approach those revenue outlooks that Bryan just talked about, we see a very clear path to being able to do that. Now, margin expansion will be a key building block in that, but it’s not the only one, right? Obviously sales leverage and then our ability to continue to leverage our interest rate, as well as tax, there are a number of levers at our disposal to drive that earnings power higher than revenue. Inside of that for margin, we continue to have the same variables that I’ve been talking about for quite some time, and the company has continued to show improvement on all those fronts, whether it’s pricing, manufacturing simplification, cost improvement, SG&A improvement - I mean, just look at our SG&A this year, we’ve been flat year-over-year while driving expansion in a number of areas in commercial infrastructure, so we’ve shown that we can do this. I’m confident we can continue moving forward and start to really see that durable revenue expansion that Bryan talked about. I’m very confident we can drive earnings power faster than revenue.
Drew Ranieri:
Great, thanks, and just another question, we had a survey out with hospital CFOs and they kind of pointed to orthopedic robotics being a key capital spending category for this year. Just curious what you’re seeing in the environment in terms of hospital purchases, and it would be great to really hear what you’re seeing or having the most success in Rosa, whether it’s greenfield placements or multi-system orders, hospital versus ASC, and maybe what your share shift has been within Rosa accounts and cementless mix. Thanks for taking the questions.
Ivan Tornos:
I’m happy to take that one, Drew. I’ll tell you, Q4 was solid both from a Rosa installation and purchasing standpoint. I’m not aware of any deal that we’ve lost, whether it’s here in the U.S or OUS relative to capital. We also do small capital deals in the surgical business and those were on track as well, so sequentially Q3 to Q4 of 2022 was solid. Because of comps, obviously, it’s a lower number than a year ago, but so far, so good when it comes to capital, so nothing that I’ve seen so far leads me to believe that we’re going to have a challenge when it comes to robotics.
Bryan Hanson:
Yes, and I think we do a really nice job of not just getting individual deals but also getting multiple placements in the same account. You do typically have hybrid accounts where you’ve got us in there with robotics and potentially another competitor, but it’s not just greenfield, it is existing accounts where you’ve gotten to the point where you don’t have enough capacity for that robotics system and they want to buy another system, so it’s a combination of those two things.
Keri Mattox:
Thanks for the question, Drew. Katie, can we--oh sorry, the cementless mix, was that part of the question, as a follow-on?
Drew Ranieri:
Yes.
Bryan Hanson:
Can you repeat the question? We didn’t catch it, sorry.
Drew Ranieri:
What was your cementless mix in knees?
Ivan Tornos:
Yes, I can take that as well. We’ve been in the low teens, as we’ve been disclosing. That’s obviously prior to the launch of Persona OsseoTi, which is now in the market, it’s been around for two weeks. The expectation is that number is going to dramatically increase, and as you know, Drew, in combination with robotics, you’re going to see a collateral effect. You’re going to see increase of cementless mix, you’re going to see an increase of robotics penetration, so we’re already bullish about where we’re going to end at the end of the year. We don’t disclose that externally, but you should expect something fairly aggressive.
Bryan Hanson:
Just to make sure no one’s confused, Persona OsseoTi, we’ve not used the name before, but that is the new form factor for cementless for Persona.
Drew Ranieri:
Thank you.
Keri Mattox:
Thanks Drew. Katie, can we go to the next question in the queue?
Operator:
We’ll go next to Josh Jennings with Cowen.
Josh Jennings:
Hi, good morning. Thanks for taking the questions. I was hoping, Bryan, to ask you--you teed up the question for us on price, and Suke, and just maybe a recap of how you fared in ’22. I’m not sure if you quantified pricing assumptions and guidance top line for ’23, but maybe if you could also just directionally help us out, figure out the difference in terms of the pricing environment in the U.S. versus Europe and Asia-Pac.
Suketu Upadhyay:
Sure, I’ll take that. First of all, thanks for the question, Josh. On pricing, we had a really good fourth quarter. If you look at our disclosure, our press release, you’d actually see that pricing is positive in the fourth quarter. Now, I would say on an underlying basis, pricing had erosion of about 100 to 150 basis points. We benefited by some year-over-year comps due to BBP, and we also had some one-time pull adjustments that were favorable in the quarter that drove us to be positive in the fourth quarter. But on an underlying basis, I would still think about it as 100 to 150 basis points erosion, which is still incredibly good versus our historical average of 200 to 300 basis points. We ended the year at about 150 basis points of erosion, again, so a pretty clear step change to where we’ve been historically. I talked about in my scripted remarks, we expect next year--or this year, I should say, 2023 to be slightly better than that annual average that we had before 2022, so maybe not as good as ’22 but definitely better than where we’ve historically been. There are a number of drivers inside of that. Some of them are transitional, some are more structural in nature. The ones that I’m more excited about are those structural improvements that we’ve made. We’ve made a lot of investments around capabilities, around systems, around analytics. We’ve got better governance, we’ve got better discipline. It’s an area we incent the field force off of now, so there are a host of things that structurally are improving our price performance as we move to 2023, and that’s sticking and part of our guide. If you think about the dynamics between U.S. and EMEA and Asia Pacific, maybe I’ll let Ivan talk a little bit about what he’s seeing.
Ivan Tornos:
Thanks Suke. So far, we’re not seeing the performance when it comes to pricing being in a single region. Frankly, 2022, all three regions beat our expectations when it comes to pricing. The most important part, I do think it’s sustainable with the guidance that we’ve given for 2023. The role of innovation also is a critical component of the sustainability of that pricing. As you think about bundle deals, as you think about bringing innovation, that is going to drive mix and in some cases a bit of price performance.
Josh Jennings:
Thanks for that. Maybe just a follow-up. I think we, at least our team has been tracking share for large joints in the United States more effectively than internationally, but maybe you could just help us understand where you think you had success capturing share in knees and hips in Europe and Asia-Pac, and just where that stands and how you’re thinking about share capture in those markets, those international markets in ’23. Thanks for taking both questions.
Bryan Hanson:
Yes, so you know, first of all, I think it’s really important - we never really pay a whole lot of attention to any individual quarter. Obviously this quarter was a pretty strong one for us globally and in the U.S., but we don’t try to over-index on that. We do an eight-quarter trend and we look at how we’re trending versus market, and I even try to stay away from specific competitors but just the overall market growth, looking at the largest players. I would say in that eight-quarter trend, as that continues to roll, we’re seeing good performance versus market in large joints, both hip and knee, probably more in knee than hip, but overall we’re feeling pretty good. You’ve got to go back to before Q2 2020. As you probably remember, we had 20 straight quarters of being below market in every quarter, so five years below market in large joints, so we definitely have seen a sea change in our ability to perform at or above market in large joints, which as you know is our biggest business. That’s the way we think about it and we break it in a bunch of different ways - year over year, we look at it on a stacked basis, we look at it sequentially, but in all those areas when we look at that eight-quarter trend, we’re feeling good about where we are.
Josh Jennings:
Thanks a lot, appreciate it.
Keri Mattox:
Thanks Josh. Katie, can we go to the next question in the queue, please?
Operator:
We’ll go next to Robbie Marcus with JP Morgan.
Robbie Marcus:
Oh, great. Congrats on a good quarter. Thanks for taking the questions. Maybe to start, in the script you talked about improving supply moving throughout the year, but you also talked about it as benefiting fourth quarter sales. What are the products that are supply limited right now, and how should we think about the potential benefit to sales from improving supply?
Bryan Hanson:
Yes, so maybe I’ll start off on a broad-based basis, because there’s really two factors that you talked about, Suke, in being able to drive performance in the fourth quarter. One would be supply challenges alleviating, but also the innovation building, because those are almost two separate things, so we’ll make sure that we talk about both of those, and Ivan, maybe talk about some of the innovation. For us when we think about the supply challenges, it really comes down to material shortages that we’re seeing, that we think are going to get better as we move in through the year, labor shortages that we think are going to get better as we move in through the year, and then sterilization capacity, which everybody is dealing with right now, that I do believe is going to catch up at some point. That’s why we think supply challenges are going to get better, but it’s pretty broad-based. I can’t look at supply challenges and say it’s just this product or that product because it’s in packaging, it’s in resins. Almost everything that we’re dealing with has some form of supply challenges, like sterilization for instance, so I wouldn’t isolate the supply challenges to a product or product set. It’s just a broad-based pressure that we’re feeling. Outside of that, it’s around innovation that’s going to be building, and maybe you can talk to some of the things you’re excited about there.
Ivan Tornos:
Yes, sure. Good to talk to you here today, Robbie. Innovation, as we discussed at JP Morgan earlier in the year, could be a three-hour conversation, so I’m going to try to keep it more or less succinct. But I will tell you, I truly believe today innovation is a key competitive advantage. Two data points right out of the gate that I mentioned, vitality index, the percentage of sales coming from new products has more than doubled over the last two years, and we expect the number to increase dramatically over the strategic horizon. Then the second part, we filed in 2022 the highest number of 510(k)s in the history of the company, and actually we had the largest number of approvals, public information, when it comes to the peer group. Breaking down innovation into three or four buckets, when it comes to knees, I already mentioned Persona OsseoTi - that is the new cementless form factor, that device that we have here at Zimmer Biomet. The clinical data we have on that product is compelling. We believe it’s highly stable when it comes to the mechanical and biological fixation. It’s extremely versatile - you can all the way to the end of the surgery decide whether you want to go cemented or cementless. It does use the Persona technology, so it’s highly anatomic, you can customize the device to any kind of anatomy. We’ve got the broadest [indiscernible] ranges. I’m excited with Persona Smart - we don’t talk much about it because we still are in the limited market trials, but I like where it’s going. I like the opportunity that we have with Persona Smart, especially later in the year. When it comes to hips, in the prepared remarks, Bryan talked about HipInsight is the first and only mixed reality digital surgery platform for hip arthroplasty. This is making procedures faster. This is increasing accuracy in the actual procedure. When you come to the meeting in Vegas at the academy, I think you’ll be impressed. It effectively gives the surgeon X-ray vision over the anatomy of the patient, the instruments, the implants. You’re going to get more accuracy, faster procedures. It is going to be transformational. I like the momentum we have with both Rosa hips and knees. We have a strong portfolio when it comes to shoulder- let’s talk about Identity, the transformational launch that we did at the end of 2022. That is followed by a cadence of launches on Glenoids, on Signature ONE planning - I could spend an hour on that, and then through organic and inorganic means, I think we have a best-in-class portfolio in sports med. This will be my three minute summary on a lot of things that are happening from an innovation standpoint, but I’ll close it by saying again, I do believe it’s a true competitive advantage for Zimmer Biomet.
Suketu Upadhyay:
Yes, and Robbie, just back to your question around supply chain, our comments on Q4 and then 2023, we did see pressure in the fourth quarter around supply chain. I think you’ve heard us comment on that, and not inconsistent with what you’re hearing around the sector, we expect those challenges to continue into 2023. The commentary on Q4, just to provide a little color that we think that our group did a really nice job in navigating that. The situation continues to be dynamic into ’23, but our expectation is that we’re going to continue to navigate that really well.
Robbie Marcus:
Great, and you touched on inorganic, you did Embody in the business line. How should we think about overall inorganic and your view at Zimmer Biomet in ’23 and beyond, and how should we think about the size of deals you’re looking to do and how fast you’re looking to move to take the inorganic and help expand the WAMGR higher? Thanks a lot.
Bryan Hanson:
Yes, we’re ready now. Again, the balance sheet is moving in a place that allows us to have even more strategic flexibility than we’ve had in the past, which is a good thing. As I’ve said, it’s probably more of those smaller to midsized deals that would be a bit closer to the vest for now, in other words closer to the orthopedic space that we are already in, but we’re ready. We’re definitely ready. Now it comes down to opportunistically finding the right target at the right price and the right returns, but we are ready to move into Phase 3 of the transformation for sure.
Keri Mattox:
Robbie, thanks so much for the questions. Katie, can we go to the next question in the queue?
Operator:
We’ll go next to Jayson Bedford with Raymond James.
Jayson Bedford:
Good morning and thanks for taking the questions. Just a couple. A clarification on the growth cadence in ’23, I think you said that organic growth would be the highest in the first and fourth quarters, but I think those are your toughest comp quarters, so I’m just wondering why 2Q and 3Q are a bit softer from a relative growth perspective. Is it simply the day rate dynamic?
Suketu Upadhyay:
Yes, let me take that one. You heard us correctly. First half will be stronger than the second half from a growth rate perspective, top line ex-FX. First quarter will be the strongest followed by the fourth quarter, and then the second and third quarter. Let me go into a little bit more detail. On the first quarter, that will be our strongest one primarily due to procedural recovery. Remember, we’re comparing against the first quarter of 2022, which had omicron in it, and therefore you’ve got a nice comp benefit. In the fourth quarter, that’s generally from a seasonality perspective from growth, usually one of our strongest quarters, and we’re assuming a nice benefit from the innovation, the momentum of innovation build throughout the year from new products and execution, so that’s why we characterize that as our second-largest quarter. Then inside of that, the second and third quarter will actually have tougher comps because that’s when we began to see some recovery last year relative to omicron. The day rate impact, you’re right - we said 100 basis points for each of Q1 and Q4, that’s a tailwind which will be offset by headwinds in Q2 and Q3, so you’ve got it largely right there.
Jayson Bedford:
Okay. Maybe just on M&A, the $0.05 to $0.10 dilution tied to the Embody deal is a bit heavier than we expected. Can you just talk about the return profile there and when can this be additive, or at least neutral to earnings?
Suketu Upadhyay:
Yes, we would see this as breakeven to positive in the first 24 months, so it’s very attractive from a margin profile, from an earnings accretion profile. As Bryan said, it’s more or less like a product launch right now, but as that begins to ramp up from a revenue standpoint and begins to cover some of the investments we’re making in a very important sector in sports and extremities, we feel good about the return profile. It meets all of our hurdles from an NPV, IRR, ROIC metric perspective, and so again it’s early days but neutral within the first 24 months.
Jayson Bedford:
Okay, thank you.
Keri Mattox:
Jayson, thanks for the questions. Katie, can we go to the next question in the queue?
Operator:
We’ll go next to Kyle Rose with Canaccord.
Kyle Rose:
Great, thank you for taking the questions. Just wondered if--apologies if I missed it, I wonder if you could give us a little more insight into where you’re at from an inflationary perspective into 2023. I think previously you talked about being at the higher end of the range of 50 to 100 BPs. I just wanted to see if that was the way to think about the inflationary impact in the P&L in ’23, and then maybe update us on the actual headwinds you did see in 2022.
Suketu Upadhyay:
Yes, so you’re right - we did point to the higher end of our range back in ’22 of 50 to 100 basis points flowing into ’23. We’re actually seeing that come through year-over-year as a headwind to gross margin. I could say, though, I’m very pleased with how the commercial and supply chain teams have reacted to that, and we believe we’re going to be in a position to offset all of that and pretty much hold gross margin flat year-over-year That’s coming from a number of variables, but again we’re really proud with what the team’s done to offset that. The impact that we saw in 2022 was, I would say, about 100 basis points as well, and if you actually look at gross margin performance, it was flat to 2021, so again the team did a really nice job in offsetting those headwinds. Once again, we’re demonstrating and showing that we can be disciplined, we can offset these headwinds and help our earnings growth over time.
Kyle Rose:
Great, that’s helpful. Then overall in the commercial channel, you talked historically about making investments in specialized sales forces and investing alongside your distributors to support some of the higher growth market segments. Just wondered, can you help us understand how these initiatives are trending, and then any potential updates in where you stand from a distributor versus a direct model across some of those higher growth segments?
Ivan Tornos:
Maybe I can take that one, Kyle. First things first, on the three segments we think that are growth drivers
Kyle Rose:
Thank you very much.
Keri Mattox:
All right, Kyle, thanks so much for the questions. Katie, I think we have time for may one or two more.
Operator:
We’ll take our next question from Chris Pasquale with Nephron.
Chris Pasquale:
Thanks. Just a quick one. First, was hoping you could give us an update on the Rosa installed base exiting ’22.
Ivan Tornos:
Yes, I’ll keep it short and sweet here. In any year, we expect to do no less than 300 installations, and we exceeded that expectation across all three regions. As you think about the future, ’23, ’24 and whatnot, that’s frankly the point of entry. I would be disappointed, maybe even jobless if we didn’t exceed that number, given the new applications in shoulder, next generation hip, and other technologies coming in, but we’re so far exceeding those expectations.
Chris Pasquale:
Okay, and then Bryan, I thought your comment that you had not started to work through the COVID backlog yet was interesting. It certainly felt like the market had some pent-up demand benefit last year, but I understand your point that the comps weren’t exactly normal. My question is if you haven’t started to make progress on the backlog yet, do you think you ever will, and are you assuming any progress on that front in 2023?
Bryan Hanson:
That is the question that I think we’re all grappling with. There’s clearly backlog. You might call it longer waiting lists, backlog - you can define it the way you want, but the fact is there’s pent-up demand for these procedures. The rate limiting factor is really capacity at the provider level. You could--because even it’s a supply challenged environment, maybe even capacity constraints the company level, but I think the bigger capacity constraint at this point is at the provider level. We actually had a third party run this analysis for us because we really wanted to get in tune to what is the size of the backlog based on the third party’s view, and then also when they believe the backlog would start coming through and at what pace. What we found in that is that, number one, they came back with there is a very sizeable backlog in orthopedics - actually, their analysis came back smaller than what we expected, but still very material. They said that when we start to work through it, it would be constrained again because of the capacity, and it was a relatively minor impact, a tailwind for sure but impact to the overall market growth, just given the capacity constraints you’re going to have in the provider for some period of time. The good news about that, I guess, is when we start to digest the backlog, it will come as a positive tailwind, likely for years. It wouldn’t be overly material in any given year, but it would be a tailwind for multiple years, so that’s the analysis that we have and we just--again, just doing the math, we don’t believe that we’re into that backlog yet. Hopefully we’ll see some of that come in 2023, but we’re not depending on that when you look at the center of our guidance range.
Keri Mattox:
All right, Katie, I think we have time for just one final question.
Operator:
We’ll take our next question from Rick Wise with Stifel.
Rick Wise:
Can you hear me now? Sorry about that.
Bryan Hanson:
Yes.
Rick Wise:
Great. Two questions. I’ll just say them right up front. First, I don’t think you commented on China, Brian. It seems like the latest COVID surge is subsiding, we’re seeing mostly negative but sort of mixed results on doing a little better. How are you thinking about China, factoring it into the first quarter and to the full year? A quick one for Suke - Suke, Brian asked me to ask you about the shared services initiative. You’re in the early innings. He said, why isn’t it moving faster? Just kidding, Suke, just kidding.
Suketu Upadhyay:
That’s a great question.
Bryan Hanson:
Rick clearly knows me.
Suketu Upadhyay:
Yes, so we’re seeing China and COVID surges clearly start to stabilize in the first quarter. It was pretty acute there in the fourth quarter. Fortunately, we were able to offset it with strength in other markets, so overall China wasn’t as big a factor in the fourth quarter and we don’t see it as a material mover, at least from a COVID standpoint, in the first quarter. We do see China as a very attractive market for overall growth in ’23 and beyond, especially now that we’ve moved through all of the pain and noise of BBP, which is now sunsetting behind us, so really feeling good about where that market is, and now that team can start to position towards not only growing the business but start to really work on the margin structure of China as a whole, coming out of BBP. So again, feel very optimistic about where we are there. Yes, what a way to end a call on a good quarter and good outlook with shared services, but I love your ambition and I’m going to share that with the leadership team that we’ve got to move faster, so thanks for the question.
Keri Mattox:
All right, thanks Rick, and thanks for all the questions. I’ll turn it over to Bryan just to close out the call.
Bryan Hanson:
Just a couple thoughts. First of all, thanks for joining us this morning. I would say I hope it’s clear that the Phase 1 and Phase 2 of the transformation of this company are well on track and we’re feeling very good about where we stand. I can tell you because of those two phases, I feel that we’ll at least take our fair share of the markets that we play in, and certainly hope to do more than that. Now we’re moving onto Phase 3, and that really is the portfolio transformation of our company. We’re looking at changing the mix of our revenue to make sure that we have more of that mix in high growth markets, and we’re going to do that in three ways, which is kind of a combination of Phase 2/Phase 3. The first one is innovation - we’re going to invest in innovation in the right areas, in faster growth markets so that we build more revenue through that innovation in those attractive markets. It gives you real time revenue growth but it also makes it sustainable by increasing the weighted average market growth of the company. The second is investment in the commercial channel. You’ve got to have the commercial channel and capability to drive that innovation and make it real. The third is portfolio--active portfolio management, really looking at moving things into the organization and out of the organization that can drive our weighted average market growth rate up, so we are clearly in that phase. We have a better balance sheet right now that we’re going to be able to leverage in that part of the transformation, and make no mistake, we feel very confident about Phase 1, Phase 2, and now Phase 3 given that balance sheet freedom that we’re going to have going forward. With that, I think we’ll go ahead and end the call.
Keri Mattox:
Yes, thanks everyone for joining us. I’m sure we’ll talk today, and of course if you have questions, please don’t hesitate to reach out to the IR team. Have a great day.
Operator:
Thank you again for participating in today’s conference call. You may now disconnect.
Operator:
Good morning, ladies and gentlemen and welcome to the Zimmer Biomet Third Quarter 2022 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today, November 2, 2022. Following today's presentation, there will be a question-and-answer session. At this time, all participants are in a listen-only mode. [Operator Instructions] I would now like to turn the conference over to Keri Mattox, Senior Vice President, Chief Communications and Administration Officer. Please, go ahead.
Keri Mattox:
Thank you, operator, and good morning, everyone. I hope you are all well and safe. Welcome to Zimmer Biomet's third quarter 2022 earnings conference call. Joining me today are Bryan Hanson, our Chairman, President and CEO; EVP and CFO, Suky Upadhyay; and COO, Ivan Tornos. Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by the forward-looking statements due to a variety of risks and uncertainties. Please note we assume no obligation to update these forward-looking statements, even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties, in addition to the inherent limitations of such forward-looking statements. Additionally, the discussions on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within our Q3 earnings release, which can be found on our website, zimmerbiomet.com. With that, I'll turn the call over to Bryan. Bryan?
Bryan Hanson:
Thanks, Keri, and thanks for joining us for the call this morning. We've got three sections of the call. First, I'm going to briefly talk about our Q3 performance and really the momentum that we saw in Q3 that has allowed us to increase our outlook for the year and doing so, even in the face of some pretty meaningful macro pressures that we're certainly still facing. I also want to spend time talking about our ZB innovation. This is clearly the driver of our continued strong performance and will be the driver as we go forward. And for the second section, Suky will provide more detail on the quarter, but probably more importantly, our 2022 guidance update. And then we'll close things out by addressing any questions you might have. Before I get started on Q3, I just want to make sure that I take a minute to say thank you. Thank you to the ZB team members that I know are listening. I know a lot of you listen to the call and I appreciate that. Your continued strong performance is -- it's just built on day-in and day-out execution. You're just focused on driving results. And I know you're showing up and facing some very, very real macro challenges right now and I appreciate it. The fact is I'm just really proud that even in the face of these challenges, you're delivering results for our customers, you're delivering results for our patients and for our shareholders and you're moving the mission of this company forward every single day. I know it's not easy but I promise you it is much appreciated. Okay. So turning to the third quarter. Although, the beginning of the quarter was a bit choppy when it comes to procedure cancellations, we did see very nice improvement throughout the quarter and we finished strong. And that execution and recovery occurred in all of our regions, but especially in our OUS regions, with both EMEA and APAC performing better than our expectations. Inside of this, we saw good momentum in our large joints business, with our knee franchise growing in the high single digits and our hip business growing just above 10%. And as you've seen, this was somewhat offset by the telegraphed and expected pressure in our S.E.T. business and our other category. Now, although, we did see the strength in the quarter, we continue to face significant challenges across foreign currency, supply, inflation and staffing. That said, the team has been able to navigate these challenges and mitigate their impact. You can't completely eliminate them, but they've certainly mitigated their impact. And they've done this through operational and commercial discipline, as well as driving our innovation in the field. And as a result, our confidence continues to grow and you see that reflected in our updated financial guidance. In short, our underlying business is clearly strong and I truly do believe it's getting stronger. Just as an example, when we look at the quarter, we announced a first-of-its-kind three-year agreement with Hospital for Special Surgery, or HSS. The partnership creates HSS/Zimmer Biomet Innovation Center for Artificial Intelligence in Robotic Joint Replacement. We're focused here with HSS to develop new tools that will be powered by AI to provide data-driven recommendations or insights to surgeons for robotic-assisted joint surgery. It's really -- it's a big deal. It's -- we're clearly very excited about it. We really do believe this is a future of medicine opportunity and we're excited to be involved with HSS. In our Q3, our new product pipeline continue to deliver as well. While it's early, we are definitely excited about the launch of HipInsight. This is the first FDA-cleared mixed-reality navigation system for total hip replacement. HipInsight is the latest addition to our OptiVu portfolio and it further expands our ZBEdge suite of solutions. Additionally, we announced the FDA clearance of our Identity Shoulder System. This is a technology that has proprietary capability of aligning each surgeon's approach to an individual patient's anatomy. All of this with the goal first and foremost of alleviating pain, but also optimizing the range of motion for that patient. And I got to tell you our existing product portfolio kept up the momentum as well. Demand continues for ROSA both in knee and hip. Persona Revision traction in the US remained strong and our limited launch of Persona iQ is driving positive feedback and interest and we're focused on aggressive data collection, so that we can establish clinical use benefits. And we expect to build on this momentum with new product launches in the coming months including as we've talked about our new Persona cementless form factor additional launches in our S.E.T. category and a hip product launch that we're excited about in early 2023. And I can tell you that all of these product innovations coupled with our ongoing efforts to reshape our business and accelerate ZB's transformation position us very well for future growth. We continue to strive to be a best and preferred place to work for our team members and we continue to strive to be a top quartile performer for our shareholders and to be a trusted partner to all of our stakeholders, but in particular our customers and our patients. Just in summary we're navigating and really managing through some very real macro headwinds that are definitely muting our growth. But we're also seeing an offset via COVID recovery very strong execution from the team and meaningful innovation in the field and against that backdrop our team continues to execute our strategy and I feel increasingly confident about our future as a company. And with that I'm going to turn it to Suky to talk more in depth about Q3 and give you an outlook for 2022 guidance. Okay Suky.
Suky Upadhyay:
Thanks Bryan and good morning. Overall, we delivered another good quarter driven by strong execution and continued recovery of elective procedures. While we continue to navigate challenges our third quarter performance gives us the confidence to raise our full year financial guidance. With that I'll turn to our third quarter results. Unless otherwise noted, my statements will be about the third quarter of 2022 and how it compares to the same period in 2021. And my commentary will be on a constant currency and adjusted continuing operations basis. Net sales in the third quarter were $1.670 billion, a decrease of 0.9% on a reported basis and an increase of 5% on a constant currency basis. US sales grew 3.2% driven by strong elective procedure recovery and commercial execution, especially in our Knee and Hip businesses. This was partially offset by expected declines in the S.E.T. and other categories. International sales grew 7.3% driven by strong procedure volumes across most markets in EMEA and APAC in tandem with lighter comps and continued strong commercial execution. EMEA performed better than expected driven by recovery in developed markets and continued strength in emerging markets and APAC performed better than expected with China largely inline with expectations and strength in Japan. Turning to our business category performance. Global Knees grew 7.2% with US Knees up 7.3% and International Knees up 7%. The strong performance was driven by knee procedure recovery across most regions and easier comps along with continued global traction of our Persona Knee System especially with Persona Revision in the US and continue to increase in ROSA procedure penetration and pull-through. Global Hips grew 10.5% with U.S. Hips up 5.3% and International Hips up 15.5% driven by strong international procedure recovery and an easier comp outside of the US. Continued traction across key Hip products including the G7 Revision System and Avenir Complete Primary Hip which is focused on the direct interior surgical approach. And lastly continued solid ROSA pull-through in the hip category especially in the US. The sports extremities and trauma category declined 2.1% and was impacted by a tough comp in 2021 and the expected pressure around VBP which is expected to reverse in Q4 and reimbursement headwinds in US restorative therapies that will anniversary in mid-2023. Within the category, we continued to deliver strong performance across our key focus areas of CMFT, sports medicine and upper extremities. Finally, our other category declined 0.4% driven by tough comps and expected lower capital sales related to a higher mix of ROSA placements versus upfront sales. Moving to the P&L. For the quarter, we reported GAAP diluted earnings per share of $0.92 compared to GAAP diluted earnings per share of $0.77 in the third quarter of 2021. The increase was driven by a decline in litigation related expenses and a tax benefit in the quarter from a favorable tax liability outcome. On an adjusted basis, diluted earnings per share of $1.58 represents a decrease from $1.71 in the third quarter of 2021. Adjusted gross margin was 70.7% in line with expectations. As previously discussed, heightened inflationary pressure will drive full year gross margins to be slightly down when compared to the prior year. As previously noted, increasing input costs from this year will pull-through into 2023 and we now expect the headwind from inflation in 2023 to be at the upper end of our previously communicated 50 to 100 basis point range. Our adjusted operating expenses were $742 million, an increase versus the prior year due to inflationary pressures and higher investments into R&D to support future product launches. Our adjusted operating margin for the quarter was 26.3%, a 200-basis point decline from the prior year and largely driven by increased inflationary pressures and continued investments into the pipeline and product portfolio. Despite ongoing macro headwinds, we continue to expect our efficiency programs to drive improved second half operating margins versus the first half of the year with a step-up in the fourth quarter in tandem with higher revenue. The adjusted tax rate was 16.3% in the quarter in line with our expectations. Turning to cash and liquidity. Operating cash flows were $451 million and free cash flow totaled $332 million for the quarter. We reduced our debt by about $160 million in the third quarter excluding the effects of foreign currency and ended the quarter with cash and cash equivalents of about $545 million. On a related note, despite a higher interest rate environment in 2022, interest expense is expected to be broadly in line with our previous expectations for the year. However, we would expect a step-up of interest expense into 2023. We have made significant progress in strengthening our balance sheet through improved financial performance and ongoing debt reduction, ultimately providing greater strategic flexibility for the company. Moving on to our updated financial outlook for the year. Constant currency revenue growth is now expected to be 5.5% to 6.5% versus 2021 with an expected foreign currency exchange headwind based on recent spot rates of 550 basis points versus our previous assumption of 500 basis points. This means that reported revenue growth will be in the range of 0% to 1% versus 2021. Also related to revenue, based on the recent spot rates, we estimate that the strengthening of the dollar through 2022 will create about a 300-basis point headwind to revenue growth in 2023. Additionally, we are tightening our expected adjusted diluted EPS range to $6.80 to $6.90. All other metrics in our 2022 financial guidance remain unchanged from our second quarter update. As a reminder, we expect Q4 revenue growth to be slightly higher than the third quarter due in part to a tailwind related to Q4 2021 VBP charges that will be partially offset by about one-day selling day headwind. In summary, we had another solid quarter underpinned by market recovery and good execution and we are pleased to again raise our full year outlook. While we expect to have to continue to navigate a number of persistent macro headwinds, ongoing market recovery in tandem with strong execution and an attractive product pipeline leaves us confident about our future. And lastly, I'm extremely proud of and want to thank our broader ZB team for all that they do. With that, I'll turn the call back over to Keri. Thank you.
Keri Mattox:
Thanks Suky. Before we start the Q&A session, just a quick reminder to please limit yourself to a single question and one follow-up, so that we can get through as many questions as possible during the call. With that, operator may we have the first question please?
Operator:
Thank you. We'll take our first question from Shagun Singh with RBC.
Shagun Singh:
Great. Thank you so much for taking the question and congratulations on a strong print here despite a pretty challenging environment. So Bryan and Suky, I was just wondering if you can elaborate a little bit more on 2023. Just on the top-line how should we think about the durability of growth? I think last quarter you talked about a 4% floor, but it looks like you have stronger momentum going into next year with a 6% exit rate. And then on margins given the incremental impact you called out from FX and inflation, do you still believe you can drive operating margin expansion next year, or is that going to be more challenging? And then I have a follow-up.
Bryan Hanson:
Okay. Two really good questions right out of the gate. So maybe Suky, I'll start with the revenue side of that equation, and then you could answer on the margin side. And certainly any color you want to provide that I might miss feel free to do that. Maybe just to make it simple I'll just start with the end of the story and then I'll get into some of the details around variables that I think are important to consider. But just going to the end of the story, we said that in an undisturbed market we would be disappointed if we couldn't grow 4%. Now I would tell you that we do not see 2023 as a normal market or not a straight market. There's just too many variables moving, but we do see -- we still do see a pathway to 4% growth. So that's kind of the end of the story. Now let's take a look at some of the puts and takes that we have to look at that could either benefit or detract from that. On the positive side of the equation, I'm going to start first with those things that are controllable by our company. There are really three major things that I look at that give me confidence and should give you confidence. Number one, it's around innovation. I'm just going to call it the innovation flywheel here at ZB is really moving in the right direction, and it's creating a solid pipeline that importantly is translating into moving our Vitality Index north and that continues to move north for us and we expect to continue to do that on a go-forward basis. So innovation is a really big part of our confidence. The team is executing. Really strong execution right now and hitting a stride which is important for momentum in the business. And the third one is around a continued focus from this organization on moving our weighted average market growth north through very disciplined portfolio decisions. I'm talking about not just active portfolio management, but truly looking at the way we spend in research and development, commercial infrastructure the way we compensate our people, the way we actively move things out of the portfolio that are not helping our win and move things into the portfolio to do. That has allowed us to increase our weighted average market growth and we're continuing to do so. So those are the positives coming into 2023. From a macro standpoint we have a couple of positives as well. I really look at the backlog of patients in orthopedics as being real. I can't put a number to it, but it's hard to size. It's hard to say when it's going to be impacting the markets the pace that's going to impact the markets. But at some point this has got to begin to work its way through the system and that could provide a tailwind to 2023. And then comps as well in 2023. It's going to be choppy. We've got choppy comps you're going to see differences in growth rates by quarter. But the fact is when I look at the full year, we should look at comps as a slight positive to 2023. And on the negative side it's the stuff that everybody is talking about unfortunately. We do have a very constrained supply challenge situation. And we're managing through it, but it's a tough road. And that's going to continue throughout 2022 -- 2023 we believe. And then staffing and our capacity has continued is not as difficult as it was but that's going to remain a headwind for us in 2023. And then we also look at recession risk on elective procedures particularly if it impacts unemployment. But all that to say 2023 is not a normal year, given all these variables. There's a lot to manage, a lot to think through and lot to contemplate in the way that we set up our guidance range. But based on what I'm seeing today, I expect there to be a four handle in that range which may or may not sound like a lot to people looking at Medtech, but to us knowing where we started that's a pretty significant step-up from where we started the journey and we're proud of it. And again we're just getting started. So that gives you a sense for revenue components and our view on revenue as we come into 2023. And then Suky, I'll pass it to you on the margin side.
Suky Upadhyay:
Yes. Thanks, Bryan. Good morning, Shagun thanks for the question. On the margin side you're right. The macro environment has become incrementally more challenging here in the back half than we originally assumed. That's been reflected in our rest-of-year outlook. And despite those challenges we've been able to raise the back end of our year. So we're pretty proud of that and the team is doing a great job. As that rolls into next year, it has become incrementally more challenging, but we still see a path to maintaining or slightly improving our operating margin versus 2022, despite some of these headwinds. And that assumes current market conditions. If things erode or if things improve, we'll revisit that. But where we are today and assume stability on some of those headwinds, that's how we're thinking about 2023. The biggest move for us really has been around FX. So as you know, we increased our full year outlook by 50 basis points to 550. That means we're exiting the year at 600 basis points of headwind on revenue. That translates to about 300 basis points of headwind into next year. So that's got a pretty significant impact on the top line in absolute dollars. And of course there's a flow-through to margin and to earnings on that. But despite that pretty big drag again, we believe there is a pathway and we're committed to maintaining or growing margins into next year. The other major area you touched on was inflation. Our previous estimate was that we'd have 50 to 100 basis points capitalized out of 2022 into 2023. We're now at the top end of that but still within our overall purview that we gave earlier this year. The real driver of that increase has been less about supply and raw material costs and less about wage and inflation, which were the bigger areas and it's more about higher freight costs right now trending higher as well as energy costs, especially in Europe. But again, at least on the bigger components of that we're starting to see some stabilization. So hopefully, that's a positive light towards the end of the tunnel. And then interest expense. Again just recognizing the higher interest rate environment we're in, we would expect overall interest expense to be modestly higher next year so just making sure that folks have that as an update to their model. But look, we're continuing to address our efficiency programs. We're going deeper and faster. I really want to commend the overall ZB team for embracing these challenges and hitting them head on. They've done a fantastic job. And again just based on that execution and assuming current market conditions hold into 2023, we think we've got a pathway to maintain or slightly improved.
Shagun Singh:
That's really helpful. Thank you so much for the color. Just as a follow-up, I was just curious to get your thoughts on portfolio management in the context shift of procedures to the ASC setting. We are hearing about 60% of recon procedures could be done in the ASC setting by 2028 or let's say even by the end of the decade. Any thoughts on that? And are you still under-indexed in that setting? And Thank you so much for taking the questions.
Bryan Hanson:
Yes. Thanks. And maybe I'll start off with that, and then Ivan, if you want to weight in feel free to do so. We clearly still see the ASC as an attractive submarket of our recon business and also clearly other parts of our S.E.T. business. It's one of the faster-growth submarkets and we're clearly increasing our focus and spend in that area. And we're doing it in a couple of ways. Number one, we're putting infrastructure in place. We've got dedicated commercial teams that focus only on the ASC. And that's important because you've got to have contracting prowess in that space and we've done that over the last couple of years and really getting good traction as a result of it. Additionally, we're making sure that we scale up in the product categories that the ASC is looking for. We wouldn't have purchased a booms and light company, if we didn't want to have that infrastructure for the ASC. Not to take anything away from booms and lights but it's not an area that we would have waited into, if it wouldn't have given us scale in the ASC marketplace. Same thing in sports acquisitions that we've done in other parts of our business. So we're really doing it two ways
Ivan Tornos:
Yes, I wanted to but I think you covered pretty much everything Bryan. But I do think one of the drivers of having a complete portfolio now is that we have best-in-class contracting. So there were contracts back in 2020 and 2021 that were not a part of Zimmer Biomet was not a part of we're a part of today. So indeed the portfolio that has been remediated the dedicated structure working. And while we don't disclose the specifics in terms of growth we are growing doubl-digit. In the ASC category here in the US, we believe will continue to grow at double-digit rates.
Shagun Singh:
Thank you.
Keri Mattox:
Thanks Shagun for the question. Yes. Operator, can we go to the next queue please?
Operator:
Thank you. We'll take Steven Lichtman with Oppenheimer & Company.
Steven Lichtman:
Thank you. Good morning. I was wondering if you could talk about the strength you're seeing in the Hip side of your business, particularly as it relates to ROSA pull-through. What are you seeing as it relates to surgeon interest on the Hip side with ROSA and would you say you're still in the early days in terms of that being a tailwind?
Bryan Hanson:
Yes. I'll probably pass the -- just that its product related more than anything I'll probably pass it to Ivan to speak to the Hip performance. And also, Ivan maybe speak to some of the things that without too much specificity that we're predicting in the future to help the Hip business as well.
Ivan Tornos:
Absolutely. Thank you. Steve, I will just summarize the Hip performance so far, when it comes to robotics at above expectations. We like the fact that this is the only pin-less robotic system in the world. We like the fact that it remains CT scan-less, which is a great advantage for the ASC setting that we're talking about. We've seen versus conventional hip procedures at similar level -- higher level of accuracy in the procedure. So for all the clinical reasons that I'm alluding to, it continues to be a best-in-class product launch. It's going to continue to scale up. We are right now placing installing about 30% of all robotics including Hips in ASC settings, so again a major advantage in settings where time and efficiency makes sense. Beyond robotics, beyond Hip robotics, we’re also excited about other product launches. We have on Hips. I think you might have heard from Bryan in the opening remarks. We've got a partnership in Mixed Reality with a company called Surgical Planning Associates that enables Zimmer Biomet to be the only FDA-approved Mixed Reality platform in hips in the US. What do we saw through Mixed Reality? We get better visibility in hip surgery. We get better accuracy, and overall better efficiency. This is some of the technologies that we're going to be explaining down this week both at Hip as well as Mixed Reality HipInsight but it's a CAGR of other products that continue to have momentum. Continue to perform strongly globally with having a complete -- we believe that we have the best robotic platform with G7 and Arcos. So again, a multiple examples of innovation that are gaining some traction both here in the US and globally.
Steven Lichtman:
Great. Thanks Ivan. And then Suky just a follow-up, thanks for the color on the 2023 inflationary headwinds. Just wondering if you could talk about offsets. You mentioned some of the internal efficiency programs. But what about on pricing, are you seeing any progress on pricing initiatives? Any color you can provide on that and what potential impact they may -- that might have on the offset side?
Suky Upadhyay:
Yes. Thanks for the question, Steven. So, we have so far this year seen an improvement in overall pricing erosion at the company level. Our historic pricing erosion was in the 200 to 300 basis points per year coming into 2022. And so far this year, we're tracking about 100 to 150 basis points. So, there's been some marked improvement. We've been making investments around data and analytics systems, better governance. We've hired additional capabilities. Ivan talked a little bit about contracting. All of these are contributing strategically and tactically to that improved price. As we move into next year, we do expect there to continue to be pricing erosion, but we would hope that and expect it to be at the lower end of our historic average, if not better. So, while we do expect it to be better than where we've been for the last several years, it will still be a headwind year-over-year. Now having said that there are a number of other efficiency programs, that we're targeting to help offset some of these headwinds. Like our new global business services or shared services operating model that we created through the pandemic. We're taking a much more targeted look at country profitability. The product portfolio active portfolio management that Bryan spoke about looking at products that have lower margin lower growth opportunities and thinking differently about those investment profiles, these are all things that are going to help contribute to offset those headwinds.
Steven Lichtman:
Got it. Thanks, Suky.
Keri Mattox:
Steve thanks so much. Yes. And operator, can we go to the next slide in the queue, please.
Operator:
We'll take our next caller from Vijay Kumar with Evercore ISI.
Vijay Kumar:
Hey, guys. Thanks for taking my question. Bryan, maybe my first one on your 4% for fiscal '23 as a starting point. I'm curious where is that floor assuming? It looks like there is no backlog. Pricing still continues to be a headwind. And it looked like you sounded pretty bullish on new products, but I'm assuming that 4% -- is assuming minimal contribution from new products, could you just go through the assumptions please?
Bryan Hanson:
Yes. I think you've kind of laid them out already. When I think about the go-forward-looking revenue growth you're going to have puts and takes. The things that we know are going to be positive for our business will absolutely be innovation. So, when I think about the calculus on revenue growth going forward, there's no question that we've included innovation. We're spending a lot of money and a lot of focus in research and development. We're bringing great products to the market and we absolutely expect that to buoy our revenue growth. That's part of reason why we gain from a 0% growth business in 2017, 2018, and now we're predicting we can get to 4%. So, that's been a big part of that movement. The execution of our team is another part of it. There's no question. I know that it's hard to put a dollar amount on momentum in an organization, but momentum does matter and we have it right now. And the other big one is that weighted average market growth. We have moved our weighted average market growth north during the last five years. So, as we get closer for our weighted average market growth to that 4%. It gives us more confidence that without share taking, we can deliver the 4% in a consistent way. Now, certainly we wouldn't stop there. Active portfolio management is Phase 3 of this organization and we're going to have more financial flexibility going forward. We're going to continue to change that weighted average market growth rate up. But getting to the 4% to start is a good thing. The negatives against that because you're saying okay we've got all these positive and why isn't it more than that? We still have real challenges around supply and that is a distractor for growing your business. And so we're going to have to manage through that as we get through 2023. We believe at least through the middle of 2023 potentially beyond. And even though staffing in our capacity isn't as acute as it was before, it's no question that this is going to be a headwind for us going forward. And of course we have to calculate some potential risk associated with the recession if that does occur. So, I think it's all those things combined in concert with this concept of having some backlog that we're hoping we can count on in 2023. But as of yet, we haven't seen it. Even Q3 which was a great quarter, we still don't believe backlog was consumed. We certainly might have had some backlog in certain areas consumed, but it was offset by some of these negative headwinds that we actually think backlog built in Q3. So, those are the variables that we're looking at as we think about 2023 and beyond.
Vijay Kumar:
That's helpful Bryan. And Suky one for you on your free cash flows year-to-date. It's really been impressive up year-on-year free cash conversion north of 80%. You're probably one of a few MedTech companies to have free cash flows up. Is that a timing impact or anything else going on in the free cash flow line item?
Suky Upadhyay:
Yes, Vijay we did -- we have posted a really good nine months here. I would say there is some timing benefit in the third quarter that will reverse in the fourth quarter. It has to do with some payments around VBP as well as some tax payments that normally would fall in the third quarter but now land in the fourth quarter. All-in-all, I think you nailed it. We're having a pretty good year in cash and we feel confident in our overall range for this year.
Vijay Kumar:
Understood. Thanks guys.
Suky Upadhyay:
Yes, thank you.
Keri Mattox:
Thanks Vijay. Operator, can we go to the next question?
Operator:
We'll take our next question from Travis Steed with Bank of America.
Travis Steed:
Hey good morning everybody. I wanted to follow-up a little bit more on the 2023 comments. I think before you said EPS to grow faster than revenue growth. And so now that was with op margins up now margins are kind of flat to slightly improving. So, I'm just curious how we should think about EPS growth now versus the 4% constant currency growth if EPS is still up but probably less than 4%? And I did want to clarify on the interest expense. You had a higher interest expense but I think you have no floating debt. So, just kind of curious what's driving the higher interest expense?
Suky Upadhyay:
Sure. So, Bryan I'll go ahead and take those. So, the one thing to remember on the EPS line is I talked about 300 basis points of headwind on revenue into next year. And so as Bryan thinks -- talks about that 4% on an ex-FX basis, you need to take into consideration the foreign currency headwind that matriculates into next year. So, having said that, with the margins kind of being relatively in line maybe slightly up and with interest expense up year-over-year, which I'll talk about in a moment, you would expect on a reported basis to see EPS kind of travel in line with overall reported revenue. So, hopefully that gives you a little bit more color. Again that's our best view right now. Things can obviously change between now and when we finally give guidance for 2023 in the first quarter of next year. On your question related to interest expense, you're right we are on face value in fixed debt, but we also do and have done some previous strategies to swap out our fixed to floating. So it's really the interest burden on those swaps that create that higher interest expense.
Travis Steed:
Okay. No, that's helpful color. And then -- and Bryan I wanted to ask on M&A. Like you kind of always talked about getting more aggressive with M&A once the market stabilize which it seems like 2023 is a year where we're in a much more "almost a normal market". So that's -- willing us to do something on M&A that can maybe move the needle a bit more and more adjacent to the portfolio versus some of the things you've been doing historically with your more smaller private stuff in S.E.T.?
Bryan Hanson:
Yes. So first of all, I want to be careful what I say because it's a pretty competitive space right now. We don't want to telegraph too much what we want to do. But clearly, we as an organization are squarely in the Phase 3 of our transformation. And we Travis have been very clear that Phase 3 is all around active portfolio management to transform the portfolio, shifting toward more WAMGR accretive markets and diversifying our business. So that's kind of a broad-based way of looking at what Phase 3 is all about for our company. And we've already made some changes here. I know you're saying there's been smaller acquisitions that we've done, but we haven't had as much firepower obviously. But we have spun businesses out as well that have helped in this strategy. That said, COVID is getting behind us. There's no question. And as a result just exactly the way you're saying we would expect to have more strategic flexibility going forward. What I'd probably be willing to say and maybe not give any more detail is that we're going to look at vetting assets across a few metrics, outside of the typical financial metrics. We look at mission centricity. We've got to make sure that we're acquiring something that can move the mission. We want absolutely something that can drive WAMGR accretion for our organization and it's going to translate into revenue growth that's accretive. Because just because you're in a fast-growth market, if you don't have a good asset you don't necessarily get the growth rate out of it and it's got to accelerate our EPS growth over time because that's kind of the vetting. And then the categories that we're going to look at would be first and foremost, probably closest to the best would be vast growth subcategories of recon. So that would be things like data robotics or building more scale in the ASC setting like we were talking about just a minute ago. It would be faster growth areas outside of recon, but still in orthopedics and that would be mainly in our S.E.T. category. So that diversifies our business away from just recon in those faster-growth subcategories of orthopedics. And then to your point attractive white spaces that are completely out of orthopedics less selective in nature and provide more diversification again out of orthopedics. I don't want to say which of those we're going to prioritize, but just know that all of those vectors are on the table and we're looking at a number of assets in each of those categories.
Travis Steed:
Great. Thanks for the color.
Bryan Hanson:
Absolutely.
Keri Mattox:
Thanks. And operator, I think we can go on to the next question in the queue.
Operator:
We'll take our next question from Robbie Marcus with JPMorgan.
Robbie Marcus:
Oh, great. Thanks for taking the questions and congrats on a good quarter. Maybe to start Bryan, I'd love to hear a little bit more about what you're seeing on the capital equipment environment. I know it's a smaller overall component for Zimmer Biomet. But you talked about lower capital sales in the quarter. It sounded like it was a bit more placement versus upfront sales. But any color on ROSA, what you're seeing if it's different US versus US? And how you expect that to trend going forward over the next 12, 18 months?
Bryan Hanson:
Yeah. I'll make some comments and then Ivan can correct anything I say incorrectly. But clearly capital is not as big a component for us. So I almost don't like talking about the capital market because I don't want to say anything that's going to hurt those businesses that depend more on the capital market. But from our perspective, where we do focus on it, it hasn't been a major barrier for us. Again, we really focus on from a ROSA perspective trying to place through agreements that allow for payment for the ROSA system through commitments and increased business. Consider a leasing arrangement, but the leasing payment is actually a commitment of business. That is what we focus on and we did more of those in the quarter and that's a good thing for our business. But we do have opportunities to continue to sell and we do not feel at this point anyway serious constraints in the capital market when it comes to ROSA. But maybe Ivan, if you've got any further color to provide around that you can help as well.
Ivan Tornos:
Absolutely, Bryan. And good morning, Robbie. I'm pretty sure that correcting my boss publicly is a bad career move. So I'm not going to correct him. Mr. Bryan, your answer is very right. The only thing, I'll add is that, it is really a global performance. So 50% of the installations are in the US, 50% are oUS. as I referenced earlier around 30% of are robots are going to the ASC, and that segment is growing, and we've seen exciting momentum with the hip software. So I would say, all in all our robotic installations placement sales are in line. They continue to move in the right direction. And as we enter Q4, we're very excited about, where we are from a ROSA standpoint.
Robbie Marcus:
Great. Thanks. Maybe as a follow-up, I think Bryan you said, last quarter extremities grew double digits. This – a little less visibility in this line item. Anything you could give us on extremities? I know, sports medicine has the HA reimbursement changes, so that there's some pressure there. But any color on what we're seeing in extremities versus trauma and sports and how that might shake out US, APAC, EMEA? Thanks.
Bryan Hanson:
Yeah, no problem. So maybe just as a quick reminder for everybody. When we think about our S.E.T. businesses and there's really no proxy for S.E.T. in other businesses, because we have different categories in it than others would probably consider. We have the upper extremities business inside of S.E.T. trauma; CMFT, which is our craniomaxillofacial and thoracic business; sports; separate from sports would be restorative therapies; and then foot and ankle. Those are the categories that we manage across the S.E.T. categories. The pressure that you were talking about in restorative therapies would be separate from sports, but it's still in the S.E.T. categories. On areas that we really focus, and invest in our growth drivers would be upper extremities, CMFT and sports. It doesn't mean the other businesses aren't important they just don't get the same level of resourcing at this point. And those three that we do concentrate on did have another good quarter. And if I look at all three of them, without giving specifics, I would say, they ranged anywhere from mid-single digits to double-digit growth again this quarter. So in the areas, where we're concentrating, there's no question that we're getting the performance in the field. A lot of that has to do with commercial infrastructure, and then the incremental support that we're giving in research and development to those areas. And of course, the acquisitions that we've been tucking in to drive a more fulsome portfolio. What you're seeing relative to pressure in the quarter for the global S.E.T. business it really has more to do with what Suky said in the prepared remarks around Asia Pacific pressure and trauma, mainly associated with VBP, which we'll reverse next quarter. And then that restored therapies pressure from a reimbursement change in G1. And unfortunately, that will carry through to the middle of 2023 or so.
Robbie Marcus:
Appreciate it. Thank you.
Bryan Hanson:
Sure.
Keri Mattox:
Thanks, Robbie. Operator, can we go to the next question in the queue, please?
Operator:
We'll go next to Joanne Wuensch with Citibank.
Joanne Wuensch:
Good morning, and thank you so much for taking the question. I wonder, if you can step back a little bit and talk about the orthopedics markets, what you're viewing as maybe changes or no changes in the competitive landscape maybe something in physician practices pricing, or generally, what you think of as sort of the state of the union? Thanks.
Bryan Hanson:
That's a great question. It's an interesting question. I think, what I'll probably do is again maybe start off on some of the things that I'm seeing that, I think are interesting. And then Ivan, Suky, Keri anybody who wants to add anything, because I think it's a really interesting question. It's a good one. My view in part the thing that, I like the most that, I'm seeing kind of state of the union that you're saying is just the rapid adoption in open arms that, I'm seeing from an orthopedics customer perspective to technology. There was a lot of question marks in my mind coming over to orthopedics, on whether or not that transition could truly occur. We saw it with Mako obviously in robotics but we're bringing a lot of other technologies to bear. And I've been very excited to see all companies kind of doubling down on the technology front robotics and data. We're all moving in that direction. And I'm hearing from our customer base that, they're looking for it and very importantly willing to pay for the value that it brings. That's really important, because if that type of innovation comes into a marketplace, particularly in medtech, it usually doesn't leave. And when you do bring that kind of technology, it is more sticky than previous technology and it does have the ability to impact pricing dynamics. Because the more technology that has stickiness to it the longer the term contracts, and the better stability you have in pricing. And you also get this benefit of increased, let's call it share of wallet or mix for every procedure. So if you can bring technology in to the very same procedure you had yesterday, you get more revenue for that procedure. And as we see that adoption continue to move up of things like robotics and data or cementless technologies in knee that actually allows a mix benefit for the entire market, and that could buoy the overall market growth rate. Taking pricing, stability, moving that forward, bringing more revenue per procedure that has a real positive effect for the overall orthopedic space. And so that's a dynamic that's happening real-time that's pretty exciting in my view anyway. But I'll open it up to anyone else if you want to add anything.
Ivan Tornos:
Maybe quickly here Bryan I'll just recap some of what you said in four bullet points here. Number one, as it was mentioned earlier, the shift of care on to the ASC and frankly in some cases something getting on a home like physical therapy is real. No longer it's all about the inpatient unit, there's a real shift of care again to ASC, and then post-surgery some of the stuff getting down a home. So that's number one. Number two, clearly the decision maker is not just the physician or the provider. The patient plays a role that's why we're excited the best technologies that we're launching that directly target consumers, patients. So it's not only just the physician and provider, it's basically physician, provider and payer. Some of the data and the technology that Bryan is talking about becomes really a powerful tool for us to engage payers in demonstrating that we are not just a solid clinical value proposition, but also an economic value proposition. Number three, and I think this is aligned with the pricing story there is an emphasis in discussing value just as much as pricing. Some of the discussions that we're having today around length of stay, reducing length of stay, some of the discussions we're having around lowering readmission rates, increasing patient satisfaction, having a shorter surgery with the same outcomes were not discussions that were happening maybe three years ago and they're happening right now. And then number four, the role of innovation. I've been in med-tech for 28 years. I was working in orthopedics 15 years ago. When I rejoined or when I joined orthopedics again four years ago, I would say that things were pretty much the same, net of a couple of robotic introductions. Over the last three, four years we've seen a lot of innovation coming to orthopedics in mixed reality, in infection management, in bringing machine learning, really thinking about the entire organization [ph]. So I would say those are the four key things that we pay attention to and we think we'll have a competitive advantage in those areas.
Joanne Wuensch:
Very helpful. Thank you.
Operator:
We'll take our next question from Richard Newitter with Truist Securities.
Richard Newitter:
Hi, thanks for taking the question. I wanted to just follow-up first, Bryan on what you were talking about on some of the pricing opportunities you mentioned with new technology. Mixed reality, smart implants, I'm curious within the buckets of mixed, the ability just to preserve your pricing as contracts roll off and discrete opportunities to charge for some of these newer areas, particularly on that third bucket, can you give some examples of where these new technologies might be able to fall into that third category, or which of those buckets should we expect more of the pricing impact from?
Bryan Hanson:
Yeah. It's -- make sure that I understand your question specifically. But when I think about the innovation that we're bringing -- and not just us by the way. That's what I like about it there's momentum across the entire orthopedic space and all the major players moving in this direction. I think in certain areas we're ahead. But make no mistake everyone is moving in this direction. So if I just take a couple of examples and hopefully this will answer the question that you're asking. Think about mymobility for instance, which is one of the first launches that we had in data collection, leveraging the relationship that we have with Apple. This uses an Apple Watch to collect data and then ultimately uses machine learning to be able to do some predictive analysis. And we're actually now looking at that through an opportunity to tell a surgeon and the patient when they're falling out of the norm for recovery. So that's the type of thing that we're able to do. And we do sell that. So there's an opportunity to monetize that application. So it's not just giving it to them and getting pull-through of implants, it certainly is getting the pull-through of implants because you get that natural gravitational pull once you bring technology in, but there's also a discrete way of making money or monetizing that mymobility application. So that's one example. Another example is robotics. I mean, robotics comes in you get that natural gravitational pull for competitive surgeons to come over, but you also get an uplift every time they use a robotic procedure because you get the uptick in disposable value. So that procedure now cost more for the account to do, but you get the benefit of robotics inside of that. So it's a fair trade. Those are two examples of the way technology is leaning in, in that way. Same thing with Persona IQ. That's the first smart implant that will be on the market. It's collecting data in a very compliant way, because you can't take it off. They're nonstop for the patient. And that will also drive a premium in the marketplace. So if you're going to use Persona IQ, you're going to pay discretely for that that sensor capability. And that's the way we're monetizing this. So you could see a combination of things where we monetize the technology or sometimes it just brings value that is unique to us that would allow us to pull in additional implants. But it's some combination of those two things. And again, Ivan, if you wanted to add anything else or Suky or anybody else.
Ivan Tornos:
I think you've done a very good job, Bryan. We can get our next question.
Richard Newitter:
Great. And just on Persona IQ it seems like the infection prevention capability or the ability to detect the infection before it occurs, that's probably going to be the killer app for a product like that that will allow you to get that kind of premium. I guess, what should we think of timelines on the data collection to be able to get an approval for infection prevention indication?
Bryan Hanson:
Yeah. What I've learned over the years is committing to timelines in a situation like this is always a bad idea. What I can say is that we are absolutely sprinting and using our limited launch focused on, getting users that will use significant quantities and be able to collect data with us so that we can ultimately look for different ways of providing insights that will matter to our customers. The things that we want to focus on first would be what are those things that we could predict that will obviously be good for the patient, but also derail the cost associated with caring for the patients, so reduce the cost of caring for the patients? And in infection is great. If you could get there, that's fantastic. If we could predict a risk of infection before it occurs, that would be fantastic. Certainly something that we're going to be looking to do but it doesn't happen very often. So you just think about the power, the number of patients you're going to have to have and the amount of data it's going to take us a little longer to get there. What we're also going to be looking at though is just loosening, which also happens. Can we predict loosening before it happens? You're looking at stiffening. There are certain things you've got to do from a stiffening perspective that if we can get out ahead of we can reduce the amount of care that needs to be provided to the patient. So there's, a lot of other things that we're looking at to try to predict that will derail, the cost or reduce the cost of caring for the patient and make sure for better outcomes for the patient. So I don't want people to get hyper focused on infection. It's something that we're going to pursue. It will take longer. But the real goal right now is to be able to look at the data that we're collecting which is significant already, and then be able to derive those insights that will change the way we care for our patient. Once we get to those we can define those that will really begin to bolster that value proposition that we have for the product and be able to support a higher price point for Persona IQ.
Richard Newitter:
Thank you.
Bryan Hanson:
Sure.
Keri Mattox:
Operator, should we go to the next person in the queue?
Operator:
We'll take our next question from Jeff Johnson with Baird.
Jeff Johnson:
Yeah. Thanks. Good morning guys. Bryan maybe even building further out on this pricing discussion, I think it's all interesting stuff and the premiums you can get on new technologies on sensor-based technologies moving that mix higher and all that that all makes sense. I'm more interested or equally interested I guess I should say on kind of your base business. I don't know what your Vitality Index is right now but let's say 70% or 80% of your revenue is generated on products that are a few years or older in the portfolio, where are hospitals that in understanding that they can't keep extracting two or three points of price even out of those base products every single year if you're going to continue to invest and develop this new technology in that, or are those conversations with hospitals improving at all in this -- especially in this inflationary environment?
Bryan Hanson:
Yeah. Probably what I'll do is I'll turn this one over to Suky, because we don't look at pricing just through one vector one lens. There's, multiple variables that we have in that equation that we think are going to benefit the company going forward. But maybe Suky, you could talk about the variables that we do look at when we think about pricing and I know Ivan probably have some color as well you want to provide.
Suky Upadhyay:
Yes. So we do think overall that this can help pricing discussions. They're becoming much more strategic in nature and more centered around value. We're not completely there where we want to be, but we're starting the dialogue more around value versus just straight price and transactions. But maybe Ivan, do you want to talk a little bit, because I know you've got some real world experience.
Ivan Tornos :
Yes, absolutely. It's a real discussion. It's happening Jeff in pretty much every country. As you think about our Vitality Index, there is a direct correlation between improvements in Vitality Index percentage of sales coming from new products and stability around price. And it may not be mixed the product launch itself that you launch in a given year. But as you launch as an example Persona IQ that creates a category contracting opportunity where we contract that for the rest of the portfolio in knees, they've got to keep a certain price. And again, that is a real discussion one very real example of how we think about it. We do that in knees. We do that in hips across the board. So, again, a very direct correlation between new product introductions Vitality Index and keeping the price premiums for the product a couple of years later, but also for the category of products in a given space.
Jeff Johnson:
Yes. That's helpful. Thank you. And then maybe just a follow-up, and I think Suky it's probably for you. But as I think about this placement strategy with ROSA kind of how the market has shifted over the last six to 12 months to more of a placement strategy and it sounds like that's probably going to continue at least for the foreseeable future. When do we get that crossover where the minimum purchase commitments maybe the minimum price points things like that that are guaranteed in those contracts those start to outweigh on the good guy side versus, I'm sure, which are some upfront costs you're having to eat here on this placement strategy and it's probably not helpful in the very short run on the margins things like that? So just when does that crossover happen that the longer tail of those positives really start to kick in? Thanks.
Suky Upadhyay:
I'll start with it and turn over to Ivan. You're thinking about it the right way right? Upfront here there is some investment relative to those placements, because we start that depreciation and you really haven't ramped up that overall growth commitment. We're still in the early innings on that, but maybe Ivan do you want to talk a little bit?
Ivan Tornos :
Yes. I would say the governance when it comes to robotics is second to none. So when we do install place our robotic unit in any center globally there is a minimum commitment of cases that the center has to perform where we take the unit back. One reason is financial. The other reason perhaps more important is from a compliance standpoint giving fair market value exchanges, we cannot have capital equipment in centers that are not delivering on the contracted number of cases. That's why we keep talking about how we prefer to place units versus semi units so we get the annuity. On the other side of the question, as we think about those cases, there is also a governance around disposables. There is zero latitude when it comes to pricing discounts on the disposables, the peripheral items that are part of that robotic case. So again, I would say that the robotic governance is second to none and really early innings here in terms of where we are in the journey.
Jeff Johnson:
Thank you.
Keri Mattox:
Yes. Thanks for the question. Yes, I think, operator, we have time for maybe one more.
Operator:
We'll take our next question from Matthew O'Brien with Piper Sandler.
Matthew O'Brien :
Good morning. Thanks for taking my questions. Just -- and maybe I'll just stick with one. And Bryan, I just want to put a finer point on this top line number that you're talking about for next year. First of all, is that 4% kind of the floor that you're thinking about for the business next year? And just as I think about the components that you're talking about between VBP and pricing and ASCs, et cetera, it just seems like the environment for hips and knees specifically is going to get more robust or really levered two Hips and Knees. So, why wouldn't 4% be the floor? And is there potential for some meaningful upside to that, as we head into next year? Thanks.
Bryan Hanson:
Okay. The positive news is, that's the question I'm getting not a question of whether we could deliver the 4%. So we're making progress there. I would say, that I still think that as I talked about before there are a lot of headwinds that we have to pay attention to. And so, I don't want to say that -- first of all, we're giving more color than we would ever give in a normal year, just given all the challenges that everybody is facing trying to help you out here. But I would say, 4% is a number that I'm saying is doable we see a pathway to 4%. But make no mistake, that there are challenges that are out in the market macro challenges, not things that are internal to our own organization that could stress that. And there are opportunities from a macro perspective, that we just talked about that could also help that. So we're trying to take a balanced view, of what could happen positive or negative to what we think organically, we can do in 2023. And that's the reason why, I would say, for 4% you should not consider a floor. 4% you should consider a good way to look at all things considered, a fair way to look at growth in 2023. And by the way if 2023 was just a normal year, and we didn't have all these noises, we believe that 4% is about the right way to think about our business. Given all the portfolio moves that we've made the WAMGR, improvements that we've made the innovation flywheel that we're now moving we believe, that's what we deserve. Could we do more than that? Certainly. Particularly, as we start to continue to move our active portfolio management strategy, we have more financial flexibility and we continue to move that weighted average market growth rate north. But, I don't want people thinking that I mean 4% as a floor. I didn't mean to attend that.
Q – Matthew O'Brien:
Understood. Thank you.
Bryan Hanson:
Sure.
End of Q&A:
Keri Mattox:
All right. Operator, I think we're a little past 9:30, unless there's any closing remarks. So Bryan, anything you'd add we're probably good to end the call.
Bryan Hanson:
Yes. I'd probably just add, I think I want people to continue to focus on the transformation that has occurred at Zimmer Biomet. We've been extremely disciplined in our portfolio decisions. And portfolio to me is, in all aspects of the business. We are biasing our spend whether it be research and development, commercial infrastructure, the way we compensate people in active portfolio management through M&A, on ensuring that we're increasing the weighted average market growth of our business and diversifying our business over time. That is happening. It has already happened and more of it will happen on a go-forward basis. And I keep talking about that innovation flywheel, but that was nonexistent just a few years ago. The Vitality Index is moving in the right direction in a rapid way, and we expect that to continue. All of that combined with the execution that we're seeing from the field is putting us in a good place, in a very challenging market. So I guess, I'll leave it with that Keri.
Keri Mattox:
Thanks so much, Bryan. And thanks everyone, for joining the call this morning. Of course, if you have questions, please feel free to reach out to the IR team. I know we'll speak to many of you today. So thanks for joining.
Operator:
Thank you, again for participating in today's conference call. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet Second Quarter 2022 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today, August 2nd, 2022. Following today's presentation, there will be a question-and-answer session. At this time, all participants are in a listen-only mode. [Operator Instructions] I would now like to turn the conference over to Keri Mattox, Senior Vice President, Senior Vice President, Chief Communications and Administration Officer. Please go ahead.
Keri Mattox:
Thank you, Operator, and good morning, everyone. I hope you are all well and safe. Welcome to Zimmer Biomet's second quarter 2022 earnings conference call. Joining me today are Bryan Hanson, our Chairman, President and CEO; EVP and CFO, Suky Upadhyay; and COO, Ivan Tornos. Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by the forward-looking statements due to a variety of risks and uncertainties. Please note we assume no obligation to update these forward-looking statements even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties, in addition to the inherent limitations of such forward-looking statements. Additionally, the discussions on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within our Q2 earnings release, which can be found on our Web site, zimmerbiomet.com. With that, I'll turn the call over to Bryan. Bryan?
Bryan Hanson:
All right, great. Thanks, Keri, and thanks to all of you for joining us this morning for the call. We've got three sections for the call this morning. The first section, I'll talk briefly about our Q2 performance from an overall perspective, and how a combination of strong execution and COVID recovery have actually enabled us to revise our expectations up again for the full-year. And that's in the face of some pretty significant macro pressures, especially around FX. I'll also spend a few minutes talking about ZB Innovation, that's a primary contributor to our performance today, and certainly our performance in the future, so we want to make sure we touch upon that. And for the second section, I'll switch it to Suky, and Suky will obviously provide details on Q2, but I think even more importantly and probably more interesting is to talk about 2022 guidance and our updates there. And then for our favorite section of the call, we'll close things out by addressing any questions you might have, either on Q2 or any other topic. So, let's go ahead and get started with Q2, and I'll start this section by saying that despite some very real and what I would define as universal challenges in our sector, I'm very proud of the fact that the team delivered again another solid quarter that actually was above our internal expectations. And I think this speaks to the team's, I'm just going to define it as, muscle memory associated with effectively managing through challenging times, and that's exactly what we have right now. With the supply concerns that are out there, it is a challenging time, and it's great to know that our team has that muscle memory to manage trough it effectively, and they continue to show that. The primary reason for the overachievement was stronger than anticipated COVID recovery, for sure, which happened in the quarter, but also just really solid and focused execution from the team across our regions and all of our business segments. From a procedure volume standpoint, the momentum that we saw in Q1, particularly at the end of Q1 actually continued through April and May, but we did see a bit of a slowdown in June, and that has actually carried over through to July. The recovery pace was different depending on where you were in the world in Q2. It was strong everywhere, but it was really strong outside the U.S., where we saw a strong performance pretty much across the board in all of our areas OUS. And inside of this, we saw solid momentum again in knees and hips. I'm really pleased to see another strong quarter in large joints, and excited that we continue to get traction for our innovation in this area. The momentum in large joints was then offset by some expected pressure in our S.E.T. businesses and our other category, and Suky will provide more detail here in a minute. I think it's pretty clear for all of us, actually, that foreign currency is a challenge, supply challenges are very real, inflationary pressures are with us right now. And those hurt us in Q2, all of these did, they're going to continue to pressure us through the back-half of '22, and potentially beyond. But just get on our business momentum this far into the year. Our new product innovation and the traction we're getting there with our customers and COVID recovery, at least the profile today, our overall confidence in 2022 has actually gotten better. And as a result of that we are raising our full-year guidance for revenue, operating margin, and earnings per share. And I think this should be a solid indication that our strategy is working, and our team is executing, really just getting it done. And our underlying business is gaining strength. And a big part of that, a big part of this momentum is our new product innovation, and continuing to deliver in delighting out customers. And in Q2, we debuted another element of our ZBEdge ecosystem, and this is an AI technology within our Omni Suite smart OR system that focuses on optimizing surgical workflow and increasing procedure efficiency. And I'd say that's important right now. It's really important because of the capacity constraints that our customers have. Separate from that, from a ROSA perspective, ROSA robotics momentum continued in both knee and hip for the quarter, and our placement pipeline remains extremely strong. And while it's still in limited launch and very early days, the feedback and interest in Persona iQ is positive, and we're focused on collecting as much early data as quickly as we possibly can, with an eye toward clearly establishing clinical use benefits, so we move into full launch in 2023, or as prepared as possible. And all of these innovations and our broader ZBEdge suite highlight the possibilities around data collection and integration on the patient and customer experience, and that's really our focus. In addition to the strength of our existing product portfolio, our new product pipeline is just as exciting. We have additional product launches planned for the second-half of 2022, especially across our knee and S.E.T. portfolios. In knee, our soon-to-be-launched Persona cementless form factor will compliment our current form factor, and provide additional momentum for cementless conversions, particularly as we get into 2023. And in our S.E.T. businesses, I'm very excited about our Identity shoulder system launch. And this is going to be a much more customizable shoulder for a more personalized feel for the patient that should optimize movement in the shoulder. We're also continuing to reshape our business and accelerate ZB's transformation. We've made significant progress in streamlining and modernizing our operating model. But we've also really focused on making ZB a best and preferred place to work, as well as a trusted partner, which are two of our strategic pillars for the company. In Q2, Zimmer Biomet was certified by Great Place to Work, this is a global authority on workplace culture. The U.S. certification was based on direct survey feedback from our team members, which I think makes it even more compelling. We also established a new function for refining and driving our environmental, social, and governance strategy, but also the commitments and actions we're taking in this area as well. We have already seen significant improvements across almost every element of ESG, and truly, we're just getting started. We see this as an important responsibility as a company, for sure, but also something we believe is critically important to our team members, our customers, and our investors. You'll be hearing more from us on the ESG front as we make further progress, and as we continue to enhance our reporting in this area. So, in summary, even though there are real macro headwinds that our team is managing, the recovery shift in COVID continues, and the execution of our strategy is making a difference. We'll need to stay close to the headwinds into the recovery; any of the last couple years have proven that things are fluid. But I do feel confident in our team's ability to navigate the path forward, and I'm excited about where ZB is going. And with that, I'm going to turn the call over to Suky for a deeper dive into Q2, and again, a look at our revised expectations for the year. Okay, Suky?
Suky Upadhyay:
Thanks, and good morning, everyone. Overall, we had a good quarter, driven by strong execution and faster than expected recovery of elective procedures across most markets. While we continue to face heightened headwinds and challenges related to foreign currency, inflation, and supply chain disruptions, our second quarter performance gives us the confidence to raise our full-year revenue and EPS outlook. With that, I'll turn to our second quarter results and how that translates into our updated full-year financial guidance. Unless otherwise noted, my statements will be about the second quarter of 2022, and how it compares to the same period in 2021. And my commentary will be on a constant currency or adjusted continuing operations basis. Net sales in the second quarter were $1.782 billion, up 1% on a reported, and 6% on a constant currency basis. As Bryan mentioned, strong procedure volume recovery extended from the first quarter, especially as we moved into April and May, with moderation of recovery in June. U.S. sales grew 1.3% driven by strong recovery in execution as COVID cases subsided and elective procedures returned especially in knee and hips. This was partially offset by lower S.E.T. growth and declines in the Other category. International sales grew 12.2% driven by strong procedural volume across most markets in EMEA and APAC. EMEA experienced rapid uptake in the second quarter across developed and emerging markets, with a generally lighter comp versus 2021. Asia-Pacific, overall, grew in line with expectations, with China performing largely as projected, and Japan growing better than anticipated. Turning to our business category performance, Global knees grew 11.2%, with U.S. knees up 4.5%, and international knees up 20.1%. These results were driven by easy comparisons OUS, along with strong knee procedure recovery across most regions, continued global traction for our Persona knee system, especially with Persona Revision in the U.S., and ROSA penetration and pull-through. While hips grew 8.9% with U.S. hips up 2.6% and international hips up 14.9%, driven by easier comparisons OUS in tandem with strong international procedure recovery. We also saw continued traction across key hip products including our Arcos and G7 system for revision and our Avenir complete primary hip which is focused on the direct anterior surgical approach. And lastly, we continue to see solid ROSA pull-through in the hip category. Sports, extremities, and trauma category increased 0.1% and was impacted by a tough comp in 2021, expected pressure in trauma due to VBP implementation as well as expected pressure in restorative therapies due to a reimbursement shift for our Gel-One product. Within the category, we continued to deliver strong performance across our key focus areas of CMFT, sports medicine, and upper extremities. Finally, our other category declined 6.1% driven by tough comps and expected lower capital sales related to a higher mix of ROSA placement versus upfront sales in the quarter. Moving to the P&L, we reported GAAP diluted earnings per share of $0.73 compared to our GAAP diluted earnings per share of $0.68 in the second quarter of 2021. Higher revenue and lower IPR&D charges more than offset restructuring and mark to market losses on our retained ZimVie stake. On an adjusted basis, diluted earnings per share of $1.82 represented an increase from $1.51 in the second quarter of '21. Higher sales in tandem with lower IPR&D in the quarter more than offset lower year-over-year gross margins. Adjusted gross margin was 71.6%, slightly ahead of expectation due primarily to better mix and lower pricing erosion. As a note, we expect heightened inflation to temper our observed second quarter favorability as we move through the rest of the year. We continue to project full-year gross margin to be slightly down when compared to full-year 2021 gross margin. And as we said, increasing inflationary pressure will pull-through into '23. And we now expect about 50 to 100 basis points of headwind from inflation in 2023 versus our previous estimate of about 50 basis points. Our adjusted operating expenses were $777 million. Lower than the prior year primarily due to the 2021 IPR&D charges referenced earlier. Our adjusted operating margin for the quarter was 28%, up from the prior year. As previously noted, full-year margins will be pressured versus the prior year due to inflation, supply chain headwind, and China VBP with partial offset by the ongoing realization of our efficiency programs. Despite these ongoing headwinds, we expect those efficiency programs to drive improved second-half operating margins versus the first-half of the year. The adjusted tax rate was 16.5% in the quarter and in line with our expectations. Operating cash flows were $346 million. And free cash flow totaled $240 million for the quarter. We paid down about $100 million of debt in the second quarter and ended with cash and cash and equivalent of about $390 million. Our improving financial performance in tandem with ongoing reductions in debt, continue to strengthen our balance sheet for greater strategic flexibility. And now moving to our updated financial outlook for the full-year 2022, we are raising our financial guidance based on the following key assumptions. COVID and customer stocking pressures will continue through 2022, but with a lesser impact than previously anticipated. Supply chain and inflationary pressures stabilized at current levels and foreign currency will be a 500 basis point headwind in '22 versus our previous projection of $350 basis points. Also, we assume about a 30% flow through of FX-related revenue headwind falls to EPS. And that the FX headwind applies to the full range of EPS guidance. Against this backdrop, I'll walk through our updated financial guidance for the year. Constant currency revenue growth is now expected to be 4% to 6% versus 21 with an expected foreign currency headwind of 500 basis points. This means that reported revenue growth is expected to be in the range of negative 1% to positive 1% versus 2021. We are raising adjusted operating margin by 25 basis points to the range of 26.75% to 27.75%. Adjusted tax rate guidance remains in the range of 16% to 16.5%. Adjusted diluted earnings per share is now expected to be higher, at $6.70 to $6.90. And free cash flow is now expected to improve to $800 million to $900 million. And lastly, net interest expense and non-operating expense will be modestly higher than the $160 million we anticipated earlier this year due to higher interest rates and foreign currency. We expect to see typical seasonality in the back-half of the year, which would suggest stronger revenue dollars in Q4 than in Q3. Additionally, we expect Q4 revenue growth to be higher than Q3 growth, in part due to the easier fourth quarter comp related to China VBP headwinds we observed in the fourth quarter of 2021. Operating margins are expected to follow a similar tend as revenue. In summary, while there are macro challenges and headwinds, our team is navigating those challenges and executing well. We are raising our '22 financial guidance due to better than expected COVID recovery, the strength of our execution, and our confidence in ZB's underlying business fundamentals. With that, I'll turn the call back over to Keri.
Keri Mattox:
Thanks, Suky. Before we start the q-and-a session, just a quick reminder to please limit yourself to a single question and one follow-up so that we can get through as many questions as possible during the call. With that, operator, may we have the first question please?
Operator:
[Operator Instructions] We will begin with Rick Wise with Stifel.
Rick Wise:
Good morning, everybody. Hi, Bryan. Hi, Suky. Maybe I'll start off with your commentary about the outlook for the second-half from a couple of perspectives. Bryan, you talked about the April-May strengthening, maybe some softening in June, and continuing. Help us understand where you're seeing it? What do you think is happening, and maybe better understand what you've dialed into the second-half? We recently did a survey of 50 orthopedic surgeons who were cautious about the second quarter, but the most ebullient, exuberant about their volume expectations for the second-half of any doctor who we surveyed. I'm confused about how we sort of reconcile those two points of view.
Bryan Hanson:
Yes, thanks for the question, Rick. So, what I would tell you is that what we experienced and, of course, we talk to a lot of our customers as well, as you would imagine. But what we experienced is in June, and then carrying through to July, not fewer procedures, but more cancellations of those procedures. And most of that was driven by either, one, the staff member having COVID or testing positive for COVID, or the patient testing positive for COVID and as a result of that they could not carry on with the procedure. And what we're saying is that we believe that could continue. We believe that could continue. Until we see a shift, we're going to assume it will continue at least through the third quarter. That's just what we're experiencing. The good news is, when I think about the quarter, we had a really strong quarter, and that business momentum -- the underlying business momentum is real, and we believe that's going to continue. But outside of that, I don't know if you want to speak more, Suky, to just our second-half view?
Suky Upadhyay:
Yes, so, good morning, Rick. Good to be with you today. So, if you look at our implied guidance in second-half at the midpoint versus what we did in the first-half, you would get about 4% operational ex-FX growth for revenue. And really what underpins that is three key assumptions we've made inside that. One, you've got tougher comps in the second-half than you saw in the first-half. You see that especially with EMEA if you just think about the second quarter growth we just posted. But it really translates to other markets as well, so tougher comps. Two, we have one less selling day in the second-half of the year, so we've accounted for that. And third, as Bryan talked about, we're just taking a prudent view on COVID especially given our index to elective procedures. We did see some softening of procedures due to those cancellations as we exited the second quarter. And we're assuming that that continues into the third quarter with a step up or improvement in COVID in the fourth quarter. Now, I would say if we don't see that pressure continue all the way through the third quarter that would likely take us to the top end of our range. So, those are some of the big building blocks that we've assumed in our second-half growth rate. But as Bryan said, we feel really confident about the execution of the team, where our pipeline is going, and our ability to execute on our recent product launches, so feeling really good about the second-half.
Rick Wise:
That's great, thanks for that. And maybe just as a follow-up to a follow-on to some of these thoughts, maybe Suky, and this is always I know your -- this kind of favorite question on calls like this at this time of year. Talk about the setup for '23, just hearing some of the factors you're talking about, improved internal execution, major new products being launching, the positive impact of your efficiency programs. It would seem like I'm leaving this feeling more encouraged about that setup for the next year than I might have, appreciating that there are many uncertainties as well.
Suky Upadhyay:
Yes, so, I'm you feeling encouraged, because we're feeling encouraged as well, that's the outlook. As we -- we're not going to get into guidance, obviously, for '23, there's still a lot more to play out in '22. But as we think about a normalized market and normal market dynamics, we would expect revenue at floor of 4%. And inside of that, based on all of the operational efficiencies the team has been very successful in making and things that we've got planned for next year, we believe we can offset these headwinds that we're seeing this year relative to inflationary pressures. And we believe we're in a position where we can expand margins into 2023. Now, albeit it won't be as great a margin expansion as you would have if we didn't have these inflationary pressures this year, but we still feel confident that we can expand margins with that type of top line growth profile into next year.
Bryan Hanson:
Yes, I'd just maybe make additional comment on that. And I would agree, yes, I think that the execution of the business and the team is very real. The momentum in the business is real. The product pipeline that we have is very strong, that we haven't even launched yet. So, for all those things coming together in a normal market, I would be very disappointed if we didn't deliver at least a 4% growth rate. And that said, that's not where we're going to stop, right. We clearly have a little more cash flexibility, and that opens up options for us from an acquisition standpoint. And we're going to be looking to add accretive WAMGR acquisitions, potentially diversifying acquisitions to bolster that growth rate over time.
Rick Wise:
That's incredibly helpful. Thank you.
Bryan Hanson:
Sure.
Keri Mattox:
Thanks, Rick. Jake, we can go on to the next question.
Operator:
We will hear from Pito Chickering with Deutsche Bank.
Pito Chickering:
Hey, good morning, guys. Thanks for taking my questions. Looking at your 2022 guidance on the margin side, can you help us understand the increase of inflationary pressures in the FX headwinds, and how that's offset by stronger revenue growth and margin leverage? And then, any views you have around positive price for your mix in your updated guidance for the year?
Suky Upadhyay:
Yes, hey, Pito, this is Suky. So, I'll start with the operating margin guide. So, inside of that, gross margin we do expect to step down in the second-half versus the first-half. We are experiencing greater headwinds due to inflationary pressures, and that's banked into our operating margin guide. And that's increased in the second quarter from our first quarter call. And what we now see is where we originally anticipated, about 50 basis points of that incremental inflationary pressure landing in 2023. We now think it's closer to 50 to 100 basis points. But again, we've completed included that in our new operating margin and gross margin guide or expectations for the rest of this year. Now, I would say, inside of that our assumption is that inflationary pressures stay relatively stable to where we exited the second quarter as we think about the rest of the year. If you take that operating margin you would expect perhaps a bigger EPS flow-through, but as you're seeing with across the sector, FX has been a significant headwind, taking our number up from 350 basis points of headwind, now to 500 basis points of headwind. And so, if you think about our EPS guide and our raise, the way to think about it is while we're increasing our ex-FX or operational growth by 200 basis points, our reported growth at the midpoint is only going up by 50 basis points. And so, if you take that 50 basis points that translates to about an incremental $35 million in revenue, including Q2 performance. And if you flow that through that would get you to about a nickel. And so, that helps support or helps give the big building blocks around the $0.05 raise that we just put in there. So, hopefully that gets to your questions, but happy to take any follow-ons you might have.
Pito Chickering:
Yes, I just want a quick follow-up here just around the 2023 commentary, with this sort of 5% FX hit you're seeing, assuming that this sort of comps out next year, can you just refresh us how that would flow through the P&L in 2023?
Suky Upadhyay:
Yes, so right now, we're assuming is flowing through to net income at about 30%. And that's inclusive of any natural hedges we have plus any FX gains and losses. Now, I would say that 30% can vary over time for a number of variables can vary based on mix of regional profit, it could vary because of timing of foreign currency changes, it could vary because of the timing of FX gains and losses. But right now, our best estimate is 30%. And as that changes, over time, we'll keep you updated.
Pito Chickering:
Great, thanks so much.
Keri Mattox:
Thanks, Pito. Jake, can we go to the next question, please?
Operator:
We will now move to Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
Good morning. Thanks for taking the question, and congratulations on a really nice quarter here. Bryan or Suky, I just wanted to confirm, there was -- international was really strong for hips and knees. I just want to confirm there was nothing kind of one-time, no catch-up there? And then just S.E.T. and other, maybe just some color on what accelerate those two businesses? Is it the new shoulder in S.E.T.? When does that happen? And the outlook for other, given some of your comments, more ROSA rentals or lease agreement, what's the outlook there? Thanks for taking the question.
Bryan Hanson:
Sure, and thanks, Larry. So, what I would tell you is that there was nothing other than some easy comps, obviously, that we had OUS. There was no one-time event that buoyed the quarter that somehow skewed the quarter. It was just the factors that we referenced already that came together and allowed for a very strong quarter OUS. So, that's the first answer. Yes, I'll hit S.E.T., and then maybe Suky, you could talk about other or Ivan, you can as well. So, on the S.E.T. side, I think it's probably good to just take a step back because we don't talk about the subcategories that often of S.E.T., and just kind of reorient everybody. We have six businesses underneath S.E.T. We have our CMFT, which is our Craniomaxillofacial and Thoracic business, Sports Med, Upper Extremities, Foot and Ankle, Trauma, and Restorative Therapies. And I would just say, in the quarter, we saw a very strong performance in our three focus area, Upper Extremities, CMFT, and Sports, with Upper Extremities and CMFT both growing double digits in the quarter, and we think that's sustainable, and Sports Medicine growing mid-single digits even with the pretty tough comp in that area, that was offset by expected pressure from Asia-Pacific in Trauma. And to be very clear, we expect that to continue, that pressure in Asia-Pacific to continue through Q3, but then reverse itself in Q4. And then in the U.S., we saw pressure in Restorative Therapies. This is due, as Suky had already mentioned, because of a reimbursement change in Gel-One. But what's important on this is that's going to accelerate into Q3, and continue through about mid-2023, and then it will annualize out, okay. So, just net-net, I would expect S.E.T. to stay pressured in Q3, and then improve in Q4. And again, we feel pretty confident that we're going to continue to see momentum in our focus areas. And maybe, Ivan, you could speak to some of the innovation and some of the things that give you confidence about those areas?
Ivan Tornos:
Sure. Thanks, Larry. And thanks, Bryan. So, you mentioned shoulder, and whether this is one device that is driving the growth, and I think the answer, Larry, is that that's not the case, it's more than one product. You are familiar with sort of Signature One Planner and guides. We launched that about three years ago, that today, above 50% of all procedures are done using this technology. And the feedback continues to be really compelling around accuracy, around the simple interface with the surgeon, the integration of the workflow, and just the fact that the surgeon is in control. Nano or the Stemless Shoulder was also launched, and is getting great momentum. The big launch that I think you're talking about hasn't happened yet, or Identity launch, which is going to be our biggest shoulder launch in the last five years, is about to get launched. And that is going to be as spacing-centric as it gets, truly a personalized solution. It has the ability of doing inlay and only reconstruction. I can spend an hour talking about it. I know you're a product guy, and what I tell you, it's going to be transformational. But beyond shoulders, in Sports Med, we have filled the portfolio very quickly, still integrating Relign, the acquisition that we did about 12 months ago. It is an all-in-one arthroscopic surgical platform; the feedback continues to be great both on the capital and consumable side. We got new products on ankles, and again I can continue to go on and on. But I will say that our portfolio in Sports Med today has everything that we need to have. And then lastly on CMFT, as Bryan referenced, that is a double-digit growth business with a combination of organic and inorganic plays. We launched new products on thoracic and neuro, we're about to launch as many as six to seven different products in the next 12 to 18 months, and we're making a lot of investments in that business. So, it's not one product, it's not one category. At least three categories are growing really strongly globally. And then, on top of that, I will say our commercial execution is best in class when it comes to the focus, the specialization, incentive plan, and our contracting capabilities, so, really excited about the S.E.T. and the momentum that we got, Larry.
Bryan Hanson:
Great, thanks, Ivan. And maybe, Suky, just speak quickly to other?
Suky Upadhyay:
Yes, so had two other questions in there, Larry. One was on the quarter for knee and hip, and anything that we saw in there. But I would say it's a very clean quarter. We really didn't see anything material or meaningful relative to shifts in timing on tenders or anything. It was pretty straightforward on both -- well, on recon in total. And then relative to other, it was down, primarily driven by the mix of ROSA; I would say the installments continue to be very strong. As a company, we're very happy with how that -- the continued uptick of ROSA and the utilization increases we're seeing. But the mix of placements versus sales was different than the prior year where we saw, this year, more placements or this quarter more placements than we saw absolute dollars in sales. And then we did see just a little bit, a modest level of pressure in surgical capital within our other business, so again, that was the -- those were the two key drivers to the year-over-year declines in the quarter.
Larry Biegelsen:
All right, thanks so much, guys.
Suky Upadhyay:
Yes.
Keri Mattox:
Thanks, Larry. Jake, we can go on to the next question in the queue, please?
Operator:
We will now hear from Josh Jennings with Cowen.
Josh Jennings:
Hi, good morning. Thanks for taking the questions. Bryan, wanted to just ask about competitive lens in joints, and what you think is driving in the marketplace decision-making by your surgeon customers? Robotics provided an edge at one point, now all the big four have the robotic systems commercialized. Do you think that surgeons are shifting back to making decisions in terms of what brand based on implant or is robotics still driving competitive wins? And just in that same vein, what -- how should we think about the evolution of ROSA from here, robotics, I'm sure it's probably a combination of implant and the robotic system, but what is Zimmer doing to evolve the ROSA system and anything that's -- any software updates that you guys have implemented so far in 2022, is that one follow-up?
Bryan Hanson:
Yes, thanks, Josh, for the question. I would say that it's always been a combination of the implant and the value of the implant to the surgeon, and will always be that way in concert with the technology you bring that surrounds the implant. That could be robotics, it could be mymobility, it could be our entire ecosystem that surrounds the implant. So, it's always been a combination of those two things. When I look at our performances, those things are now coming together in a cleaner market than we've had in the past. And so, the underlying strength we've had as a business has been masked by some external things. As those clouds begin to move, I think you're going to see the real performance of this come out. But with that said, obviously, Ivan is here, he's much closer to it even than I am. So, maybe you could speak to what you're seeing out there?
Ivan Tornos:
Yes, absolutely. So, on question number one, Josh, I concur with Bryan, the physician is clearly the decision-maker. But the role of the provider and the payer is also very, very important, and obviously we target those decision-makers as well. Relative to ROSA, I'll tell you Josh, what makes ROSA unique is not that it is one product; it is part of an ecosystem that consolidates a lot of different parts and pieces. It's fully integrated with a lot of pre-op stuff, our partnership with Apple and mymobility or planning software, the fact that you can use ROSA with the number one in the world, Persona, the connectivity with some data points, the OrthoIntel data platforms, and obviously Persona IQ at some point. So, I think it's more of an integrated solution than just one product that is driving those decision-makers to come our way. If you go out there and ask physicians why -- or payers, for that matter, why are they choosing ROSA; other than the outcomes and the technology at play, they like the efficiency, they like the fact that our preplanning is easier, they're seeing the outcomes. And I think those are the reason why we're seeing the great momentum with ROSA. So, hopefully, that answers your question.
Josh Jennings:
Thank you. And Bryan, just wanted to ask about if there's any opportunity you see for maybe product line pruning or even if you're working through any product line obsolescence that could -- you could drop some -- maybe anchor product lines and help catalyze some stronger growth at your different business units? Thanks for taking the questions.
Bryan Hanson:
Yes, it's a great question. And it's interesting, because when I first started at Zimmer Biomet, I made the mistake one time on an earnings call talking about the fact that we are going to reduce SKUs, and the stock just tanked because normally what happens when you do that, there is risk associated with revenue. What we have done then is just to be quiet about it. But we have also been doing it. We had dramatic decreases in SKUs over the past 4 years, dramatic. And we are going to continue to focus on that because there is a lot of inefficiencies in orthopedics if you have multiple product lines you are trying to cover and it reduces focus in the field. So, we really are trying to focus on the main brands, push from an incentive standpoint our teams to focus on those brands and rationalize categories they are just not as important to us. So, again we have been doing that very quietly but very effectively over the last 4.5 years.
Josh Jennings:
Great, thank you.
Bryan Hanson:
Sure.
Keri Mattox:
Thanks, Josh. Jake, if we can go to the next question in the queue.
Operator:
Our next question will come from Jayson Bedford with Raymond James.
Jayson Bedford:
Good morning and congrats on the products. Just a couple quick ones, in response to Rick's question earlier, Suky, you mentioned margin expansion in '23. I was just a little unclear was that in reference to gross margin, op margin, or both?
Suky Upadhyay:
Yes, Jayson, great question. Good clarification. It's really more about operating margin expansion. As I said, we've got some inflationary pressure this year that's going to capitalize into next year, which is going to put some headwind into gross margin year-over-year. I don't want to get into exactly where we think gross margin is going to end. We just know that year-over-year as a starting point you've got 50 to 100 basis points working against you because of things that happened this year. Having said that, quite excited about all the progress the team is making to help offset those. We are doing some really good things around pricing which is improving our profile. You saw that in this quarter we expect to see some of those more strategic and tactical levers continue to play through for the rest of this year and into next year. Really happy about what the supply chain and commercial teams are doing relative to site optimization and cost down in manufacturing. Even in the backdrop of a very dynamic supply chain market and the challenges with trying to get product and packaging materials and logistics all sorted out in a very again volatile market. And then beyond that in SG&A, we are going to continue to look at improvements in our go-to-market market models commercial models across the world. We have already implemented a number of those, for instance, in Europe where we look to restructure and rethink how we go to market in lower margin markets as well as lower margin business categories. And then, the global business services operating model that we created during the pandemic is ripe for further leverage. And we think that we can continue to drive efficiencies by putting more of our activities into those service lines. So, we feel really good that despite ongoing gross margin pressures because of these inflationary headwinds that we see a clear path to operating margin expansion into '23. So, hope that gives you a little bit more color and clarification on where expect to see it.
Jayson Bedford:
Yes, it's very helpful. Just as a bit of unrelated follow-up. In terms of patient backlog, I thought it was somewhat refreshing that you didn't talk about hospital staffing issues. So, my question is what do you think is posing the biggest hurdle to kind of unleashing that backlog. Is it patient reluctance to come in? Whether it would be COVID or economic reasons, or is it still hospital staffing? Thanks.
Suky Upadhyay:
I think it's a good question. I would say it's a bit balance. It's multi-factorial. I would say that even in the quarter -- in the second quarter we didn't talk about backlog much. But I do believe in certain areas where you had capacity, capabilities, we did see some backlog come through. Unfortunately, what we continue to see is also an offset typically of that in other areas that have either COVID or staffing pressure that then drive the numbers down. So, I have kind of continued to see there is a kind of offsetting of areas that can drive forward and pick up backlog in other areas that are probably building backlog. I don't know when that's going to stop. It's hard to predict. But the good news is that we are seeing that anyways very strong procedure growth. We're just seeing canceling being the thing we are concentrating on. So, we're not seeing COVID driving ICU beds in the wrong direction or capacity of ICU beds being in challenge. It just is patient wants to come in. The procedure is being scheduled either the patient or the staff member gets COVID and they can't conduct the procedure. That's what we are seeing and that's what we saw more in June and July so far.
Keri Mattox:
Thanks for the question, Jayson. Jake, can we go to the next question in the queue please?
Operator:
Yes. We will hear from Kyle Rose with Canaccord.
Kyle Rose:
Great, thank you for taking the questions, and good morning. Suky, you made some comments on the last question just about pricing updates. So, I wonder if we could just take that one level deeper. Where are you seeing the biggest success I guess in price pressures near term? And then when you think about strategically over the long term, I mean where do you see pricing power and opportunities to potentially flex from a pricing perspective longer term?
Suky Upadhyay:
Yes, thanks for the question. I will actually turn it over to Ivan. He is probably the closest in doing the day-to-day [cost head] [Ph] on this.
Ivan Tornos:
Yes, absolutely, thanks. So, I will tell you. When I joined this business four years ago, the normal price erosion was 3 even 400 basis points per year, in some categories, 500 basis points. That's not what we are. That's not what we are going to be. I would be extremely disappointed it would not below end of the range of 2% and that is on a bad day if you ask me, 200 basis points of price erosion. Relative to what we are doing, what are seeing success, first of all I'll define the journey as a three stage journey. Tactical, number one; strategic, number two; transformational, number three. We completed number one. We have done a lot of tactical stuff. Raising price for non-core products, raising price in non-core markets, thinking differently about different customers, business segmentation, all of that is being done. We are getting get success. Stage number two, strategic, I would say we are probably midpoint in that stage. It's about category contracting. We have number one position in hips and knees in many different accounts around the world. We have now done a good job in leveraging that position to bring S.E.T. another categories that is happening. Now that we have truly an ecosystem solution, we are bundling -- I don't like that word but that's the one that comes to mind our ecosystem and contracting across the [indiscernible] care. We are doing a lot of things in terms of thinking ASCs. We incorporate a ton of people in our contracting group that are thinking more strategically about those relationships, line extensions and what not. And then at some point, we will get into the transformational stage and that is how do we leverage all this data we are getting to do a risk chain agreements? Now that we learnt product platforms like Workai, we are able to engage in predictive analytics. We are going to leverage that to really understand what happens 3 - 6 months after a surgery is done. So, three different stages I would say again with our stage 2. And we are not at least or at worst at 2% price erosion, we are not doing our job. Thanks for the question.
Kyle Rose:
Thanks you. That's very helpful. And then just one follow-up on ROSA, maybe just talk a little bit about utilization you are seeing and some of the positives, and then I will take a stab, but overall installed base in your percent of knees and hips following through that would be very helpful.
Bryan Hanson:
I think you've always got to try to take a stab at those two things, therefore we are just not going to provide it. But I do want, Ivan, if you could talk about the momentum? I mean we are seeing really strong momentum in ROSA. It was a little off from the other category given the mix as Suky referenced before. We sold less than we did the prior year. But the placements were still strong. And the pull-through on those placements are also still strong, but maybe you can speak.
Ivan Tornos:
Yes, sure, absolutely. I'll tell you I am really proud of the work that the team has done globally. We are now in 40 countries with ROSA over the last three years. But I am even more energized about what's happening or what's going to happen over the next three years. But to throw some color, I won't disclose the number of placements. Bryan has done that in the past. I won't talk about penetration. But I will tell you that is double digit here in the U.S. We had a solid Q2. Sequentially, we grew both on sales and placement, overall installment Q2 22 versus Q1 of 2022 versus last year's comps was a headwind. We continue to see a nice mix in terms of the installations in an inpatient unit than in an ASC unit. I mentioned earlier that the feedback from customers is very compelling when it comes efficiency. And today about 30% of all installations have been in ASC. So, that's a great lead indicator to what's going to happen here given the migration into the setting. From competitive standpoint, we track that obviously very closely. About 40% to 50% of installations are happening in competitive accounts. And again, the number of returns and the feedback has been very, very positive in that space as well. So, really excited about where we are. It's a global business continue to see penetration in the right direction. And as I think about next three years, we have as many indications coming, I would say that we are in the really, really early innings of this game.
Keri Mattox:
Thanks, Kyle. Jake, can we go to the next question please?
Operator:
Yes. Next we will hear from Jason Wittes with Loop Capital.
Jason Wittes:
Hi, thanks for taking the questions. Maybe a follow-up on -- appreciate the detail on ROSA, curios on the competitive accounts that you are getting in with ROSA, are they using multiple robots? Or, is it usually just a single robot that's ROSA? Or how would you characterize the competitive inroads?
Ivan Tornos:
Yes, absolutely, Jason. Thank you. It really depends. We are in a lot of teaching institutions. And as you can imagine when you are talking to HSS, Hospital for Special Surgery in New York or the Cleveland Clinic or Mayo, they do like to have a wide range of different robotic solutions. So, it's not uncommon to see two or even three robotic systems there. So, that comes to mind when it comes to selection. As you look at other savings, that depends. It depends on the preference. When you have high volume surgeons that you used to using Persona, then they tend to gravitate towards ROSA because it does integrate Persona and it drives a different level of efficiency. So, that depends on the volume of the surgeon, teaching institution, non-teaching institution. Yes, we do have examples in the U.S. and globally where you have as many as two or even three robots in an account.
Suky Upadhyay:
And it's not surprising that that occurs. Even if you just look at the implants, even in a very strong account that we would have, usually it's not homogenous with one implant. You typically have competitive implants in there as well. So, we follow suit that if you are going to move into robotics, you likely will have more than one robotic system.
Jason Wittes:
Okay, I appreciate the detail. And then a follow-up on Persona IQ, I know you mentioned, you kind of working out or building up a case for the value proportions. I assume that's going to be premium price products. And it sounds like you are ready to fully launch that in 2023. How do we think about that in terms -- I mean in terms of the price and value proposition for the patient and the hospital?
Suky Upadhyay:
You are absolutely right. It is going to be it is today and it will be a premium priced product. It is one of those opportunities for sure while just like you would see in robotics disposables. You would see in my mobility. You would see in a cementless uptick in price point. And that's why we are sprinting right now to be able to collect data to prove out the value proposition as I said in my prepared remarks. But Ivan, obviously you are very close to launch maybe you could speak to that as well.
Ivan Tornos:
Yes, I am not sure, Jason that we are ready to commit to a launch date. We knew early on when we acquired this technology when we partnered with Canary in this technology that this was going to be a limited market release. And it could take 6, 12, or 18 months depends on the level of data we are getting. We knew that the [Elemar] [Ph] was more of clinical exercise than a commercial exercise. We are on track with the things we want to get. Really the Elemar had three stages. Number one is validation of the value proposition. And again, we are getting millions. And I am talking millions of data points so far in this Elemar, anything from what happens intraop on resection, gap balancing, the level of alignment, the cutting, what happens postop in terms of range of motion, in terms of gait, speed and all kind of things. With all those data points, we need to understand what is the true value proposition for that patient, that provider, and that physician. The second part is how do we -- once we really do launch the product, how do we make this efficient. What's the pathway towards activating sites at a faster speed? How do we change surgeons? How do we deal with data questions around privacy and what not? And then number three is really what's next? We don't want to be just a smart knee company; want to be a smart solutions company. So, we have got a pathway to get into hip. We have got a pathway to get into shoulder. When understand both cemented and cement less needs; different platform. And to that end, there is a lot of data we are getting to understand what is that we are going to do from a portfolio standpoint. So, I am not going to commit to a date for launch. But I would tell you we are on track in terms of gathering all the data and the roadmap ahead.
Jason Wittes:
And maybe -- thank you, that's helpful. Just maybe one quick conceptually question here. Is the market ready to pay up for these AI technologies, these planning technologies? I mean traditionally the market has been very focused on implants, implant cost. So, this is a bit of a shift. Has the market been receptive? Do you think they are respective? Do you 2023 they are receptive to paying these types of premiums for these sort of new take on technologies?
Bryan Hanson:
I'll answer in a couple ways. I think first I would look at data points that would suggest that the market is ready. And I just look at ROSA, I look at robotics in general, it wasn't that long ago that there was an assumption that orthopedics would not pay a premium to bring robotics in the play. I think we are finding that's changing very rapidly. I really do believe robotics would become a standard of care at some point. I think it's the same thing. This is the next leg of the stool. I really do believe that data collection and the informatics capability as a result of that will be something that people will desire and pay for. We have to prove it. We have to collect the data, create the data lake, create insights as a result of that, and give guidance to surgeons from that data. Once that occurs and we can then predict things ahead of time and change care as a result of that, there's value in that, there's no question. Remember, there's still a large percentage of patients, somewhere in the neighborhood of 20%, to get a knee procedure that are not happy for whatever reason. And when you talk to surgeons, even really good surgeons, they don't always know why. They'll say, "Hey, I had the best surgery day, the X-ray looked fantastic. That patient is not happy, I do not know why," we don't either, but I'm pretty confident with the data we're collecting we'll be able to predict it in the future and then change the care for that patient. And that's really good for the patient, and that's why we're doing it.
Ivan Tornos:
I'll just maybe quickly add that in addition to the example of ROSA, which I think is a great example of the market being ready to pay for technology, we really have thousands of patients in or the mymobility by Apple platform, so another example of when you do provide the right data people will pay for it. There's two questions that every day we are trying to solve with payers and providers, can we lower the length of a stay in a hospital post surgery? Can we lower readmission rates? And if you can do that through data and technology, the market will pay for that. And we're making [both base] [Ph] that we're going to be able to do both of those.
Keri Mattox:
Yes, Jason, thanks for the question.
Jason Wittes:
Thank you very much. I'll jump back in queue.
Keri Mattox:
No, thank you. Jake, if we can go to the next question in queue that'd be great?
Operator:
And we'll hear from Chris Pasquale with Nephron.
Chris Pasquale:
Thanks. Just following up on the Persona IQ question, can you give us a sense for the scope of what you're collecting? And is this something we should expect at the AAOS meeting, in spring, or is the timing not going to line up with that?
Ivan Tornos:
Well, I tell you I could spend an hour talking about these things that we're collecting, but from pre-op, to intra-op, to post-op, through different devices we're collecting data. Now we have Persona IQ, which is obviously intra-op and post-op, we're looking at things such as resection data, gap balancing, the accuracy on cuts, the overall alignment, the range, so of motion expectations, we're looking at post-op at asymmetry of the actual implant, the step length, what else, gait speed, how well are you doing at physical therapy post surgery. Again, I can go on and on. In addition to those patient-centric measures, we're looking at how to design products in a better way based on how those implants are functioning post-op, post surgery. But I think, in the academy, you'll see much more in this space. But again the idea going back to value proposition is out all these multiple data points, what are the two or three that are going to drive their premium and their willingness to pay. I'm looking forward to sharing that in the academy.
Bryan Hanson:
Yes. And I think it's important because you said it, it's not just IQ, it is an ecosystem of a capability that allows us to collect data across all areas of the procedure, before, during, and after, in a combination of those things that will create that data lake that is just too vast for us to make any sense of, but with machine learning we can look for patterns in the data and ultimately provide insights as a result of it.
Chris Pasquale:
I see, thank you. And then I just wanted to clarify on the pricing commentary. You guys used to give the impact of price by business, went away from that this year, but if I look back over the past seven or eight years, the average impact was just a little bit over 2%. So, I'm a little confused by the three to four-point comment, and how much of an improvement we should really expect if 2% is the target going forward, may be you could just clarify that? Thanks.
Suky Upadhyay:
Yes, so, I'll take that one. So, overall, on a consolidated basis, you're right, it was somewhere in the 200 to 300 range, but if you deconstructed that and actually looked by category, and we did provide that level of data, you would see that knee and hip or recon was higher on price erosion than the overall consolidated. And you saw generally lower than that average in S.E.T., so that was your offset. I don't know if Ivan --
Ivan Tornos:
Now just to be clear on this, 300 to 400 basis points, that is large joints in the U.S. So, when you look at the overall category it might have been different. But yes, it was not unusual to see 300 -- even higher than 400 basis points here in the U.S. given the way that we contract then -- and historical factors.
Chris Pasquale:
Got it, thank you.
Keri Mattox:
Thanks, Chris. Jake, we have time for maybe one or two more questions. Can we go to the queue?
Operator:
Yes, we'll hear from Steven Lichtman with Oppenheimer.
Steven Lichtman:
Thank you, good morning. Follow-up on S.E.T., you talked about the pipeline you have coming in your focus areas. As you think about overall S.E.T. versus WAMGR for those markets, do you see a pathway to improved foot and ankle growth versus that market, either through internal innovation or M&A [technical difficulty] overall thoughts on your foot and ankle from here?
Suky Upadhyay:
Yes, so what I'd say is, again, all six of the categories we have in S.E.T. are interesting and attractive categories, there's no question. We do bias our investment and our focus areas, which are the ones that are referenced, CMFT, sports, and upper extremities, mainly because those businesses have either been able to acquire a full portfolio, have a full portfolio, and we see a cleaner path to leadership in those spaces, and so they get disproportionate amount of investment. And as a result of that, we expect above-market growth in those spaces. In the other categories, they still get investment, they're still important to us; we just expect a different performance because the investment level is different. Now, if any one of those businesses comes back with a pathway, through acquisition or otherwise, that would also show a clear path to leadership, it could become a focus area as well. I don't know if you wanted to add anything, Ivan?
Ivan Tornos:
I'll just keep it very succinct and say we have not given up on our foot and ankle. There is, I would say, a meaningful amount of R&D that is going to add space. We recently closed the buyout of an extremity, which was a part of [indiscernible]. We now have a more complete offering in forefoot, midfoot, and hindfoot. We had some biology solutions that we're launching as we speak. We had a partnership with a sports medicine group on sutures. So, there is a compelling portfolio, I would label it, that we're seeing that we're going to be able to launch here.
Steven Lichtman:
Got it, okay. And, Bryan, you said before that as you guys moved into Phase 3 of your transformation M&A got crimped, obviously, by COVID. The impact there from a procedure volume basis has ebbed, but obviously there were some other macro headwinds, your balance sheet is in good shape. So, how do you feel, overall, about the environment for Zimmer to go out and do some deals here over the next 12 to 18 months?
Bryan Hanson:
Well, it'll tell you, a lot better now than it did before, that's for sure. The fact is our financial flexibility is improving, the balance sheet looks strong. And we've earned the right now to be able to truly increase our focus in this area. Don't get me wrong, all along, since we've been in Phase 3 we've been looking at the market, looking for assets that we could pursue. But now, our ability to execute this phase of our transformation is more real. And just to give you some color there, we truly will be looking at mission-centric targets, because that's the number one criteria. We're also going to be looking for places where we believe or spaces where we believe we can get a path to leadership, at least at some point. We're always going to be looking for WAMGR-accretive assets, and then those things, that as a result of that, can drive faster growth and faster EPS growth over time. To size it, we're probably looking more small-to-medium size deals. And it would be across three areas. Number one would be to diversify in our faster-growth orthopedic markets, like extremities for CMFT, and even settings like ASC, but also, secondly, to diversify our revenue outside of traditional orthopedics with an eye towards those things that are a little less selective in nature. And then inside of recon, we're actually looking to enhance our position in those faster-growth submarkets of recon so we can bring our WAMGR up there as well, things like data and robotics. So, that's where we're going to focus in. We've been at Phase 3 for a while, we've got a lot of things that we're interested in, and now we have a little more financial flexibility to move in that direction.
Keri Mattox:
Yes. And Jake, we probably have to end there. I know we're a little bit above 9:30 here, but thanks for all the questions, all great from the queue. Bryan, don't know if there's any closing remarks that you'd make to round out the call?
Bryan Hanson:
Yes, I think what I would say it, hey, it was a strong quarter, but it's just a quarter. The fact is the momentum has been there for a long time. And I'm just really happy that finally, with some of the clouds being removed, you can actually see the performance that the team is actually delivering. I think -- I do want to make sure that we're clear, as we think about that concept of we should at least do a 4% growth rate, it's going to be choppy for a while. The fact is it's not a clean market, it's not an undisturbed market, and it's not going to be for a while. So, you could expect quarters that might be above that 4%, and you might expect to see quarters that are below that 4% just given all that noise in the market. Make no mistake, the business momentum is real. The team is executing right now flawlessly, and our product pipeline is really, really strong, so, our confidence is high. Even though it's going to be choppy for a while our confidence is very high.
Keri Mattox:
Okay. Thanks, everyone, for the questions. Of course, if you have others, please don't hesitate to reach out to the team today, and I'm sure we'll talk soon. Thanks for joining.
Operator:
And this concludes the Zimmer Biomet quarterly earnings call. Thank you for your participation.
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet First Quarter 2022 Earnings Conference Call. [Operator Instruction] As a reminder this conference is being recorded today, May 3rd, 2022. Following today's presentation, there will be a question-and-answer session. At this time, all participants are in a listen-only mode. [Operator Instruction] I would now like to turn the conference over to Keri Mattox, Senior Vice President Investor Relations and Chief community Officer. Please go ahead.
Keri Mattox:
Thank you, Operator. And good morning, everyone. I hope you are all well and safe. Welcome to Zimmer Biomet first quarter 2022 earnings conference call. Joining me today are Bryan Hanson, our Chairman, President and CEO; EVP and CFO Suky Upadhyay and COO Ivan Tornos. Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by the forward-looking statements due to a variety of risks and uncertainties. Please note, we assume no obligation to update these forward-looking statements even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties, in addition to the inherent limitations of such forward-looking statements. Additionally, the discussions on this call will include certain non-GAAP financial measures, reconciliation of these measures to the most directly comparable GAAP financial measures is included within our Q1 earnings release, which can be found on our website, zimmerbiomet.com. With that, I'll turn the call over to Bryan. Bryan?
Bryan Hanson:
Alright, thanks, Keri and thanks to all of you for joining us this morning. I'm going to talk briefly about our Q1 performance and our revised expectations for the full year. I'm also going to spend a few minutes talking about our recent innovation and our key drivers for long-term growth. And then after that, I'm going to turn it over to Suky, who will get into more details on the quarter, but also very importantly, our full-year guidance update. And then we'll close out the call with your questions, of course. So, let's get started with Q1. We had a strong quarter, well above our own expectations and obviously above external expectations. And the primary reason for that level of over achievement was stronger than anticipated COVID recovery in the quarter, particularly when we looked at the back half of the quarter. And if I look at the U.S. recovery, it was stronger and faster than I think anyone expected pretty much across the board. And while we continue to see COVID surges in EMEA and China, the impact on overall procedure cancellations has been minimal at least so far. And inside of that we saw very strong performance in large joints, and in particular our Knee franchise, while our set recovery lagged our core recon business at this point. We know it's still early in the year but based on what we saw in the quarter, and really current trends in the Q2, our confidence in 2022 growth has definitely increased. And as a result, we're raising and tightening our full-year guidance. Now there are clearly a number of headwinds that we're facing. Supply challenges, inflation, Russia, Ukraine. But given our revenue dependent on elective procedures, COVID recovery outweighs those headwinds. And that's why even in the face of these challenges, we're able to raise our outlook for the year. Okay. So, turning the page a bit, outside of external influences on our business, our strategy is working and our underlying business is very strong. Our new product pipeline continues to deliver. We're adding. more innovation and value to our ZBEdge ecosystem. If you were an AAOS, you saw our recently launched WalkAI. This is ZB's first AI based solution. We also showed recently launched functionality for Mymobility platform, this is under the umbrella of our exclusive partnership with Apple. Our ROSA Robotics momentum continues to be very strong. And the early feedback on Persona IQ, even though it's in limited launch, is very positive. All of these things combined are highlighting the possibilities around data collection and integration on the patient experience. We also continue to drive significant demand and traction with Persona Revision in our Knee franchise. With Avenir Complete in our Hip franchise, and our signature ONE planner in shoulder. And our new product pipeline remains very strong with additional product launches planned for 2022, especially across our Knee and [Indiscernible] portfolios. We're also continuing to reshape our business and accelerate ZB's transformation. That means of course, streamlining and modernizing our Operating model, but also focusing on making ZB a best preferred place to work and a trusted partner. Just in Q1, we scored 100% on the human rights campaign’s corporate equality index. We made Forbes best large employers list, and were named one of the most innovative companies by FastCompany for our ROSA Robotics platform. We have also prioritized our environmental, social, and governance, or ESG commitments and our actions in this area continued to expand. We have committed to key environmental standards, delivered on social giving pledges and set DENI standards and long-term goals in this area. And we've enhanced our overall reporting of ESG progress internal to our own team members, but also to investors. And finally, our transformation also includes, as you know, active portfolio management and as a part of this, we completed our spin of ZimVie on March 1st. That was ahead of schedule and certainly as a part of our active portfolio management strategy. So, in summary, even though there are real macro headwinds that we will have to manage, and I have confidence in our team to do so, the recovery, the shift in recover really in COVID is the bright spot we've been waiting for. And we're excited about and it's certainly changed our view of 2022. And with that, I'm going to turn the call over to Suky for a deeper dive into Q1 and our revised expectations for the full year. Okay, Suky.
Suky Upadhyay:
Thanks, and good morning, everyone. We had a good quarter driven by faster-than-expected recovery of elective procedures, giving us the confidence to raise our full-year revenue and earnings per share outlook. Let's turn to our Q1 results and how that translates into our updated full-year financial guidance. Unless otherwise noted, my statements will be about the first quarter 2022 and how it compares to the same period in '21, and my commentary will be on a constant currency and adjusted continuing operations basis. Please note we have changed our geographic revenue reporting to U.S. and international, and we released a Form 8-K last week to provide unaudited recasted financial information related to our ZimVie spin off, as well as a change in non-GAAP reporting of in-process R&D-related expenses. Moving to first-quarter performance, net sales in the first quarter were $1.663 billion up 3.9% on a reported and 6.8% on a constant currency basis. As previously guided, selling days contributed about a 130 basis points of tailwind in the quarter. Revenue was driven by continued execution along with stronger and faster than expected COVID recovery across most markets, with the largest uplift in the U.S. After significantly pressured January, recovery ramp through the quarter with improvement in February and a strong rebound in March. On a consolidated basis, March grew versus pre -pandemic levels and that recovery has continued into April. U.S. sales grew 5.8% driven by strong recovery as COVID cases subsided and elective procedures returned. By the end of the quarter, U.S. cancellation rates have returned to pre -pandemic levels and procedure volumes were above 2019. International sales grew 8.1% driven by strong growth across Europe and we saw continued recovery despite COVID surges in certain European markets in China. Turning to our business category performance in the first quarter. As a reminder, China VBP is expected to be about neutral to overall revenue growth for the full year. And so far, the 2022 impact is broadly in line with our original expectations. While we don't expect the material impact from VBP on full-year 2022 growth, we do expect there to be fluctuation by quarter. In the first quarter, we saw about a 200 to 300 basis points of pressure across our global Knee, Hip and S.E.T. segments, which we expect to be broadly offset through the next three quarters with the majority coming in the fourth quarter. Global knees grew 11% with U.S. knees up 11.7% and international knees up 10.1% driven by solid commercial execution, continued traction for Persona Revision, robotics pull-through, and strong knee procedure recovery across most markets.
.:
This decrease was driven primarily by an unrealized investment loss due to a decline in the value of our investment in ZimVie, and higher litigation-related and restructuring charges. On an adjusted basis, diluted earnings per share from continuing operations of a $61 represents an increase from $55 in the first quarter of 2021. The increase was largely driven by higher sales and lower interest expense. Adjusted gross margin was 70.6%, lower than the prior year as expected due to VBP and higher input and manufacturing costs, which were partially offset by higher volumes and better mix. Our adjusted operating expenses were about $735 million, up from the prior year driven by higher investments in R&D. Our adjusted operating margin for the quarter was 26.4%, down versus the prior year but ahead of expectations and driven by higher revenue. The adjusted tax rate was 16.1% in the quarter in line with our expectations. And now turning to cash and liquidity. Operating cash flows from continuing operations were $360 million and free cash flow totaled $223 million for the quarter. We reduced our debt by about $650 million, excluding the effects of foreign currency and ended the first quarter with cash and cash equivalents of about $435 million. Our improving financial performance in tandem with our ongoing debt reduction continue to strengthen our balance sheet. Moving to our updated financial outlook for 2022 while we continue to manage through macro headwinds related to foreign currency, Russia, inflation, and supply chain challenges, a faster and stronger COVID recovery, in tandem with a positive first quarter give us the confidence to raise and tighten our financial guidance. Against this backdrop, our current expectations for the full year are as follows. On a constant currency basis, we now expect to grow 2% to 4% versus 2021, with an expected foreign currency headwind of approximately 350 basis points. This translates into a reported revenue growth projection in the range of negative 1.5% to positive 0.5% versus 2021. Note that the selling day tailwind that we saw in the first quarter will be fully reversed in the fourth quarter with no material full-year selling day impact. Adjusted operating profit margins continue to be in the range of 26.5% to 27.5%, this assumes inflationary pressure of about a 150 basis points versus our original estimate of about 50 basis points. Of the incremental a 100 basis points of pressure a half will hit 2022, but be offset by expected higher revenue, and roughly half will be capitalized and impact 2023. Adjusted tax rate expectations remain in the range of 16% to 16.5%, adjusted diluted earnings per share is now expected to be higher at $6.65 to $6.85. And we are increasing free cash flow to $750 million to $850 million. Inside of that guidance, we have a tougher comp in the second quarter due to COVID recovery we experienced in 2021. But we do expect revenue to grow in the low single-digits over the second quarter of '21 and to exceed pre -pandemic levels for the full quarter. In summary, we expect that the environment will remain dynamic, but we believe the pace of recovery, our continued execution, and the strength of ZB's underlying business fundamentals, position us well to improve our financial outlook. With that, I'll turn the call back over to Keri.
Keri Mattox:
Thanks, Suky. Before we start the Q&A session, just a reminder to please limit yourself to a single question and one follow-up so that we can get through as many questions as possible during the call. With that, Operator, may we have the first question, please?
Operator:
Thank you. Ladies and gentlemen, at this time, we will now begin the question-and-answer session. One moment, please, for the first question. Our first question comes from Joanne Wuensch with Citi.
Joanne Wuensch:
Good morning and thank you for taking the question. Very nice quarter. I'd be interested in your view of what's happening at the hospital level. We've been hearing all season about staffing headwinds, about CapEx spending headwinds. And I'd be curious to get your opinion on that. Thank you.
Bryan Hanson:
Yes, Thanks. Maybe I'll just start off and then I've got Ivan sitting next to me. We are actually here traveling in Europe, because we take the opportunity to get out and start Q2 strong. What I would tell you is that yes, we are definitely still seeing pressure from the staffing standpoint and we actually, even today would expect that to continue throughout the year. What I think about the quarter itself, whether it be COVID or staffing of a combination of the two, it was pretty tough in January. Got better obviously in February and that was really, really good. And in March -- actually March was a month that we had at growth over 2019, so true growth over pre -pandemic levels, and we've seen that continuing to April. So, all positive from that perspective, but we do expect that staffing pressure will continue to be a challenge throughout the year. Just not as intense, I think is what we thought when we started the year. But, Ivan you're out there more than I am in the U.S. maybe you could also.
Ivan Tornos:
Absolutely. Thank you, Bryan. So, I concur, it remains a headwind. What I will tell you is that in the U.S. we have seen our cancellation rates. So, the cases -- will also be the cases that get canceled every week, to starting to look pretty much similar to those cancellation rates in 2019. In the past, most calculations were ACE related, so fear and anxiety. In the early IQ, the staffing challenges, then 2021 it was mainly staff -- agreement, staffing agreement. And that [Indiscernible] seen that it's starting to look [Indiscernible] less of probably in Europe than other markets in the U.S., but it remains a challenge in the U.S.
Joanne Wuensch:
Sorry, capital?
Keri Mattox:
Joanne, was your follow-up about capital and the capital markets, net pressure?
Joanne Wuensch:
Yes -- No, cap -- Yes. Capital purchasing. Thank you.
Bryan Hanson:
So, I'm having a hard time hearing her for some reason. I don't know if maybe Keri, you could repeat the question. I couldn't hear it.
Keri Mattox:
Sure Bryan, Ivan. Joanne was asking about capital purchasing and what we're seeing on those trends.
Bryan Hanson:
Yeah, I can see that question as well. So primarily we sell capital in two businesses, for surgical business and obviously robotics, Knee and Hip [Indiscernible]. We are not seeing anything that tells us that there's a shortage of capital. What the strategy for the quarter is being more around placements than selling robots. But under surgical side, we're not seeing a challenge, we're not seeing that we've seen less fluidity than in Q4. So, I'm actually pretty optimistic in terms of where we are when it comes to a capital allocation from a hospital standpoint. But again, as I mentioned, we are doing more placement than sales in the quarter. We did more placements than sales in the quarter. Thanks for the question.
Joanne Wuensch:
Thank you.
Keri Mattox:
Thanks, Joanne. Lauren, can we go to the next question, please?
Operator:
Our next question comes from Travis Steed with Bank of America.
Travis Steed:
Hi. Good morning. Thanks for taking the questions and congrats on a good quarter. I appreciate the colors on the margin pressures but just want to make sure it's clear how we're thinking about how these pressures flowed through to 2023. Sounds like 50 basis points of incremental pressure at this point. But also, curious if you have any offsets like pricing I -- it was kind of noticeable that you didn't put pricing in the press release this quarter for the first time. So curious how you're thinking about that.
Suky Upadhyay:
Yes. Sure. Hey, Travis, this is Suky. Thanks for the question. I'll start and then maybe turn it over to Ivan on the pricing question that you had. So, you heard correctly, we think that inflationary pressures are going to be roughly a 150 basis points of a headwind on margins this year. Our original estimate back on the Q4 call was 50 basis points. So, we think we're somewhere in the additional a 100 basis points range from where we originally were. And we were seeing that pressure grow post our call, but it really started to accelerate with the war in Ukraine. And I don't think that's inconsistent with what you're hearing really across this sector and probably in other industries as well. Now, the way this works is part of that pressure, about half of that will hit this year, but given the way we account for costs and variances, and given the higher level of inventory that we carry, about half of that additional pressure will be capitalized and deferred into 2023. So about 50 basis points of that incremental 100 will find its way into next year. I would say that the key challenges that we're seeing, again are very consistent across the sector from a supply chain standpoint. First, freight is higher; commodity costs are higher, energy costs and labor costs. But the biggest culprit within that is our commodity costs. The good thing is, we're starting to see some stabilization around that. We do still see some higher costs related to stainless steel, packaging materials like plastics and resins and of course titanium, which we're doing a lot of spot buys to secure our safety socks and supply chain. But what we're hearing from our supply chain organization is that starting to stabilize. Now, the environment is still very dynamic, so we'll keep you posted as the year progresses. But the good thing is that the largest headwind that we've got feels like it's beginning to stabilize a bit. Inside of that from a pricing standpoint, we did see a slightly better quarter, this quarter on from a pricing perspective year-over-year. Some of that is due to some specific strategies and tactics that the team is putting in place to better control pricing erosion year-over-year. And some of that I think is just a little bit still opportunistic because with the continued COVID headwinds that we saw in the beginning part of the quarter, that results in lower volumes, that then results in lower rebate thresholds for some of our customers. That sort of helps a tailwind on our pricing probably temporarily while our volumes are more muted. But maybe Ivan, you want to talk a little bit about what you're seeing in the pricing environment and our ability to offset price or past price pressure onto the end markets.
Ivan Tornos:
Absolutely Suky. Hey Travis, Ivan here. So as Suky do it too, and in our normal -- the normal price erosion is around 2 to 300 basis points. We did achieve better at price erosion in the quarter, some components of that are sustainable, others they remain to be seen. But I will tell you that we got over next today in the U.S. and frankly in Europe and APAC that we didn't have in the past, as we see our vitality Index or percentage of sales coming from new products, we see that as a tailwind. And again, we'll see how that develops in quarters to come. And from an incentive standpoint, for the first time we will have very clear incentives in all commercial annexation to maintain or gain price. So, we're not making a commitment to do any better than the 2 to 300 basis points, given that a large percentage of the business is contracted. But certainly, we have the plans and the government that we didn't have before. So, fingers crossed on that one.
Travis Steed:
I appreciate all that color. And Suky one follow-up on China. Just want to make sure we're modeling that correctly. It sounds like it was 200 to 300 basis points headwinds to total company organic growth this quarter, but that comes back in Q4. And if you just look at China volume with the shutdowns, I'd love to hear how that's playing out in Q2 and the recovery there from a volume perspective.
Suky Upadhyay:
Yeah. So, the China volumes have clearly been negatively impacted because of some of the COVID surges that you've been hearing about. It's most acute in Shanghai, we did see earlier in the quarter some additional lock downs in other cities. The good thing is, right now we're not seeing any lock downs beyond Shanghai, now there is limited movement in other provinces, but there are no shutdowns and we're still seeing cases being performed there. Shanghai still remains the most acute situation in China. I'll just back up a little bit. Remember, China is in the low single digits of revenue of the entire company, and Shanghai inside of China is just a relatively modest fraction. So, while we're still seeing pressures specifically in that province, I think it's manageable and somewhat moderated. Again, broadly beyond China -- beyond Shanghai, we're seeing stabilization to improvement. We just have to keep a very close eye on China, [Indiscernible] on Shanghai. But the way you're thinking about the impact of VBP is correct.
Travis Steed:
Okay, thanks for the [Indiscernible].
Bryan Hanson:
Yeah, I might just add this down -- I might just add some commentary there. It's actually because even though there's a lot that's happening, that's different than expected in China, the overall impact into the quarter was about what we expected. And even into now coming into Q2. So, for different reasons -- but the fact is, even though we're seeing lock downs in Shanghai and disruption as a result, we're also seeing delays in VBP implementation. And those are almost balancing each other. So, while certainly China was still a headwind for the quarter, from a top and bottom-line standpoint, it was pretty much in line with what we expected even though for just different reasons.
Travis Steed:
Great. Thanks, Brian and Suky.
Keri Mattox:
Thanks. Travis. Lauren, can we go to the next question, please?
Operator:
Our next question comes from Amit Hazan with Goldman Sachs.
Amit Hazan:
Oh thanks. Hey, good morning. Maybe start with market share and I wanted to ask you the question. I know it's hard to tell the trends given the last couple of years. But as we look at three-year CAGR is and just try to make sense of it's going on in the U.S. It's actually not very clear that you are consistently gaining share. And I'm trying to think about this in the context of the 600 or so ROSA at least that you have in the field. I'm sure that's a little bit higher now. And just trying to understand if there are offsets there or how you're thinking about market share in the U.S., for knees in particular, but knees and hips, because the data doesn't strongly suggest that you're gaining share.
Ivan Tornos:
So, I'll take that and then I'll pass it over to you, Bryan. I'm going to talk about some specifics. But it probably all depends on how you're running your data, because I would probably argue the different outcome. The fact is it's choppy. It's really choppy. And we're looking at this thing in every different way you can; sequential growth versus the previous quarter, we're looking at it versus prior year, versus 2019 because that was your last good year. We're looking at it on a stack basis. You name it, we're running the analysis to get a sense for what we're doing. What I've said always is that I don't really trust any given quarter, but I do look at trends, and almost any which way I slice it, I do see us moving in the right direction and of course I also see things that you can't see in our own business. The combination of the trends that I'm seeing, looking at it a lot of different ways and also just the things that I see in my own business, I feel very confident that we're moving in the right direction and we're doing the things that we need to do to be able to drive attractive growth. A big one that I look at is vitality index. We had a more slow vitality in the business, we've doubled that in the last few years and that continues to move north. We've got a very strong pipeline of products. So, to me, when I think about that performance, it's clear. I mean, the transformation is real. And the good news for us is that as COVID and staffing issues start to clear and continue to clear, that the reported performance that we have as a business as finally going to start reflecting what we actually know is happening in the business.
Bryan Hanson:
But what gives us a lot of confidence again, is the innovations. So maybe Ivan, you want to talk about some of the innovation that gets you excited.
Ivan Tornos:
Yes, absolutely. I mean, I look forward to the day where we have objective market share data on because I also differ from that statement on markets there. But that said, I'm beyond excited about what we got in the store. So, some of the products that we keep talking about, Russ, you mentioned 600 [Indiscernible] at place, I believe the number is higher now. We're getting a strong penetration in key accounts, both in the hospital setting and in the outpatient setting. We have indications, plenty of indications to come. Our revision has only been launched here in the U.S. but continuous to grow at unprecedented rates. It's pulling our primary needs as well along the way, ZBEdge, I would spend an hour talking about all the things that you probably saw in [Indiscernible] in Chicago. Whether it is WalkAI, Mymobility on [Indiscernible] configurations. By the way, we have the largest number of enrollments these last quarter, Cementless knees penetration is also in the teens, and that's before we launch a new form factor device at the end of this year, which is going to give us break in the category. So that's just the [Indiscernible], and Amani, we launched six products in the last two years. As you look into Hips, we are performing strongly with Avenir Complete, direct Anterior, our revision platform. We don't talk enough about that. Somebody is also performing very well. In said CMSD sports made on trauma are doing well, we got some noise with that trauma early in the year, but we got new launches and new product launches to come. And just a ton of stuff coming from -- and data on technology standpoint. So, I don't know, you were looking at the same data, when it looks the market share. But what I do know is that as you look at the innovation story with the [Indiscernible] index being 2x what it used to be, and the pipeline being dramatically higher than it used to be three years ago. I'm pretty confident that we're going to remain above market for the [Indiscernible].
Amit Hazan:
Thanks for that color. We'd love to know specifically if you do have the data on the U.S. knees and hips, what your data set, I'm sure it's better than ours. But the second follow-up would be for you, Bryan. Just on capital allocation. Just how you're thinking about M&A post the spin now and this in particular environment. If you want us to be thinking about natural limits to kind of the size of the deal you'd be looking at and how you're thinking about adjacencies versus whiteboard opportunities. Just any color would be super helpful. Thanks so much.
Bryan Hanson:
Yeah. So maybe I'll start kind of topline and then I'll hand it to Suky to talk about capital allocation and our current focus there. But yes, for sure, M&A and active portfolio management is a big part of what we define as Phase 3 of the transformation. Just as a quick reminder, we started this old journey in Phase 1, which I'm just going to define as kind of the hearts and minds. In other words, kind of mission and culture focus. Significant upgrading in talent at the leadership team level to make sure we have the right people to transform the business and then stabilizing just a number of significant issues around quality compliance, turnover supply, you name it. Phase 2 was more around a true long-term strategy, making sure that we're shifting to innovation versus remediation. And really changing the kind of innovation we were focused on and then augmenting our structure and operating mechanisms to ensure that we truly do drive execution and accountability to the strategy. And the Phase 3 is where we are in kind of to your question. We are looking to transform the portfolio of the company. Now, COVID has hampered our ability to do that because it's put pressure on the business. We haven't had as much firepower. But the fact is, we have made decisions here that are moving the needle. Number one, we've got the spin of the dental and spine businesses, which we think is the right thing for both businesses. And although there have been smaller because we don't have the firepower, we've done acquisitions to be able to build, scale and attract as basis. But for sure we will continue to focus on active portfolio management, acquiring companies that can drive weighted average market growth for us in our mission centric. I'm not going to get into specifics on where we would focus because as you probably know, it's pretty competitive out there right now for assets. But this is something that we absolutely will focus on in Phase 3. The good news is as we continue to see stabilization in the market, we're going to be able to continue to buy down debt, which is important to us and eventually increase the firepower to do this. Suky, maybe I'll just turn it over to you to talk about current capital allocation.
Suky Upadhyay:
Sure. Thank you, Bryan. And thanks Amit for the question. Our focus has been very consistent in ensuring that we continue to pay down debt and maintaining our investment-grade. And just a little back point here. Since 2019, we've paid down almost $3 billion of debt and that's in the backdrop of a pandemic that's has significant pressure on our financial performance. It speaks to the strength and durability of our cash flows as a company. But when you combine that priority as capital allocation together with improving financial performance relative to growth and EBITDA, it really does start to set us up pretty nicely for more strategic optionality as Bryan talked about with active portfolio management. I think in a bigger way, it enables us to look at opportunities to accelerate the top and bottom-line growth for the company while diversifying it as well. And I think all of those things are very credit positive. And so, while we will probably take more of a front foot in that active portfolio management category as Bryan talked about, especially now, coming off the spin. And quite frankly, the organization has gotten out more bandwidth having undertaken in and gotten that very heavy lift behind us. We will undertake that active portfolio management with an eye towards to maintaining our investment-grade ratings. So feels good to start to turn the corner on that and to know that all of our hard work and de -levering the balance sheet, improving financial performances is actually starting to pull through.
Keri Mattox:
Thanks for the questions [Indiscernible], can we go to the next question, please?
Operator:
Our next question comes from Jeff Johnson with Baird.
Jeffrey Johnson:
Thank you. Good morning, guys. Maybe going back to Travis's question, Suky, on -- just on gross margins, I think you're clear on the 50 basis points that's being capitalized and will come out next year. I think the way Travis phrased it and then kind of I was hoping that -- here and answer to was are their offsets to that or should we just assume that that 50 basis points that comes out next year is kind of how we should think conceptually about gross margin being down 50 basis points next year then. Thanks.
Suky Upadhyay:
Yes. The team is actively looking and always looks at offset to any headwinds, whether it's current year, future years, etc., so I think it's too early to tell exactly what next year's gross margin will look like. But all things being equal, we've got that added headwind. The team is looking at, both from a supply chain standpoint, more faster structural changes across our plant footprint. We're looking at potential procurement and category savings through procurement to potentially offset those headwinds. And I think you've heard about Ivan talking about price, we're making some nice, I think durable headway into improving our price discipline and our price performance. So, we're going to continue to actively look for some offsets to that headwind. But right now, it's just too early to tell -- to say exactly what that 50 basis points ultimately translates to in 2023.
Jeffrey Johnson:
Yeah understood. And then I think you guys are pretty clear on kind of the R&D spending things like that. But where are we on a recovery in spend on things like conference attendance, doc training, corporate travel, things like that. Are we at a level now that is back to normalized and just grow off that or is there a recapture that still has to happen there?
Suky Upadhyay:
I would say we've definitely increased since 2021 and obviously since the depths of the pandemic, I think there's likely a little bit more room to go to bring back spending as we continue to see topline performance improved throughout the year. So, and especially in the backdrop of the new products launches that we've got coming out. We want to make sure that we're investing appropriately from a commercial perspective, to make sure that those launches are successful. I don't know Ivan, if you want to say anything else there, but I guess the key thing we'd expect to see a modest increase that will be involve.
Ivan Tornos:
Just maybe quickly hearing that Jeff, I will tell you that the fact that they [Indiscernible] what it was three years ago tells you that we haven't a slowdown from an R&D perspective. Within R&D you got two components. which is sustaining engineering and then new product introductions. And the number of new product introductions in '21 and '22 is dramatically different than in past years as we get into '23 and '24, it's even higher. So definitely no cuts when it comes to true innovation. And then relative to [Indiscernible], that's another area that we're trying not to cut. Might have done some adjustments throughout the pandemic, but I will tell you we are full force globally when it comes to [Indiscernible]. So, R&D [Indiscernible] remain sacred cows here from an investment standpoint. Thanks, Jeff.
Jeffrey Johnson:
Yeah. Thank you.
Keri Mattox:
Thanks, Jeff. Lauren, can we move into the next question in the queue, please.
Operator:
Our next question comes from Shagun Singh with RBC.
Shagun Singh:
Thank you so much for taking the question. So Q1 ex-FX revenue results in 2022 guidance implies lower quarterly growth for the balance of the year. So, what's assumed in your guidance beyond Q1? How should we think about the cadence of that? Perhaps you can touch on both revenue and EPS. Any color on Q2 will be helpful. And then just as a follow-up on portfolio management, how are you thinking about your diversification strategy that you've previously alluded to? It seems like a lot of these procedures, at least on the [Indiscernible] are coming in from the ASC. So, any color there would be helpful. Thank you.
Bryan Hanson:
So, Suky, why don't you start with the cadence of growth, as much color as you want to provide there obviously, we're not providing quarterly guidance, but you can get more color there. And then I'll talk about the diversification.
Suky Upadhyay:
Yeah so, you're right, the forward-looking based on our increase in our guidance range on ex-FX, the midpoint now being at 3% versus the former at flat year-over-year. But given our first quarter would suggest lower ex-FX growth rates for the remainder of the year. And that's primarily due to, as we previously discussed, much tougher comps as we move through the rest of the year. The first quarter of this year, we were of course, comparing against the first quarter of 2021, which had a very, very deep COVID, impact. And so, it wasn't unexpected that you'd see a much better Q1 than the rest of the year. So, it's really comp related on the rest of the year as to why that growth rate is lower than the first quarter. As we think about cadence of revenue growth, as we move forward, we would expect -- we already talked about second quarter being in the low single-digits on an ex-FX basis. And the fourth quarter based on normal seasonality, we would expect the second quarter to be stronger than the third quarter. And then of course, the fourth quarter to be the strongest quarter of the remainder of the year, very consistent with our former seasonality that you saw last year and prior to the pandemic in 2019. And we would also expect earnings to follow that same suit. And as revenue gets stronger, so will the operating margins. So, earnings are expected to follow in that same cadence as revenue.
Bryan Hanson:
Great. And on the concept of diversification, when we think about active portfolio management, it's definitely still there. Clearly, we want to make sure that we're diversifying our business and we think about it really in three ways. It's not just product segment diversification. Clearly that's an area of concentration for us because there are faster growth categories that we play in that we want to build scale in. But also, geographic expansion, just to make sure that we're taking advantage of fast-growth areas in the world. And then ASC, you referenced ASC as an attractive setting, we've actually already acquired areas to build our scale in that setting and we built commercial infrastructure to pursue ASC as well. So, we look at it for sure in diversification to drive weighted average market growth, but we don't just look at it to be a product, not just by geography, not just by setting, but all three of those.
Shagun Singh:
Thank you.
Keri Mattox:
Thanks, Shagun. Lauren, can we go to the next question in the queue?
Operator:
Our next question comes from Drew Ranieri with Morgan Stanley.
Drew Ranieri:
Hi, thanks for taking the questions. Just on your set business for a moment. I appreciate that it lagged in the first quarter, but just trying to get a better sense of how that progresses through the rest of the year. I think you mentioned in your prepared remarks that there's some new products coming later this year, but maybe go into a little bit more detail there, just how are you thinking about your set market or set to growth from a business perspective. Thank you.
Bryan Hanson:
Maybe just quick topline and then Ivan, maybe you could speak to some of the things you're seeing inside of set. First and foremost, it is an area that we're very interested in. Not all the sub-segments of S.E.T. are created equal for us or certain categories that we're investing more heavily in because they're more attractive, we think we've got a better chance to win. Quite frankly, we really do believe that we've got scale that we can continue to move forward. So not all equal, but certainly an area of overall concentration for us. I would say that you're going to continue to see some pressure in the next couple of quarters. A lot of that comes from the fact that we still have pressure in VBP and in trauma. And then I think as you get to the end of the year, particularly some of those new products being launched, you might have an opportunity to see some of that move in the right direction. But just make no mistake, S.E.T. is an important area for us. We've put commercial infrastructure in place, we've acquired technologies in this space, we continue to innovate in the space and we will continue to focus in S.E.T. I don't know if you had anything else you want to --
Ivan Tornos:
Just maybe just back up a little. We've seen [Indiscernible], so in the category, as I mentioned earlier, sports are going very well. The acquisition and integration are relying continues to go very nicely here in the US and in Europe. We've seen an increasing penetration on Signature ONE. We are now integrated in shoulder. We Mymobility, which is the integration of ZBEdge components into the shoulder platform. Comprehensive and shoulder is growing, in the strong team globally. So as sports and upper extremities have done very well, CMFT and integration of [Indiscernible] is also going very well. Continue to gain share on hip trauma, [Indiscernible] closer where we have some headwinds. It was referenced by Suky in the prepared remarks. [Indiscernible] trauma primarily because the headwinds in APAC, but also in the U.S. some time it was some contracts. But overall, the category with the exclusion of trauma right now, it seems going really, really well. And as I mentioned, a different forum, we got more product launches in the segment in 2022 at the end of 2022 and in 2023, that we have had since 2015, 2016. So, the innovation to start is that as well. So, things are on track.
Drew Ranieri:
Got it, thank you. That just on robotics, I think I heard you mentioned that there was a struggle. It was a struggle quarter on placements than capital. Can you just talk about whether you expect that trend to continue through 2022? What drives is just the hospital spending environment or are you doing new sales strategy with how to place robotics? Thank you.
Ivan Tornos:
Absolutely, thanks. So, it's very fluid. It's very customer-centered. We give the option of the placement, we obviously give the option of selling the ROSA, then sometimes we do a hybrid. In 2021 with did more sales than we anticipated given some of the macro-dynamics as we entered 2022, we see on a particular placement that that delivers better financial returns, we want more of that. That said we still are selling robots. And as I said earlier, we're not seeing any clear headwind today. That capital is not at a low for the robots, both in the hospital setting and in the ASC.
Keri Mattox:
Thanks, Drew. Lauren, can we go to the next question?
Operator:
Our next question comes from Matthew O'Brien with Piper Sandler.
Matthew O'Brien:
Morning. Thanks for taking the questions. Bryan, your comment on recovery, that was interesting. As we look at the market as far as deferred procedures go, we come up with the kind of $1 billion to $2 billion of deferred orthopedic revenue globally over the last couple of years. So, if we get to maybe a third of that here in 2022, I know you can't get to all of it because of staffing headwinds. But given your market share position, get this be kind of a 100 to 200 basis points of tailwind to the topline, is that what you're trying to communicate this -- today as far as what kind of impacted the business we should expect this year from the backlog?
Bryan Hanson:
Yes. So, to be clear, the backlog, we still believe there's got to be a backlog. I mean, just the fact there's just been no fundamental shift in the disease state itself and there has to be a backlog just given what's happened over the past couple of years. But what we're not trying to state right now, given our guidance, is that we expect a big part of that backlog or really any of that backlog to influence our numbers. So, we're just saying that we believe as we get to the back half of the year, we're going to get to a normal environment, not making assumptions about capitalizing or benefiting from no backlog. We do believe at some point it has to come through, but we believe at this point it's not going to be some kind of a massive impact that comes quickly, just -- you're just going to have capacity issues associated with that. We do believe it should be a tailwind, but we think is going to happen over years, not months or quarters, would be our view on it. But just to be very clear, we're not expecting that as a part of our guidance right now in backlog recovery.
Matthew O'Brien:
Okay. Thanks for that. And then maybe, Suky, because I know you monitor this pretty closely on the ROSA side of things, you've been placing a lot of systems over the last couple of years. Maybe talk a little bit about that pull-through revenue that you're going to get on the implant side and where we are in that cycle, is it going to be a meaningful contributor to the Knee business here in '22 or is it more kind of spread out over the next couple of years? Thanks.
Suky Upadhyay:
Yes. Sure. Probably -- I mean, Suky probably better, maybe even have Ivan talk about that because I mean, that realization of pull-through is now. I mean, it's happening. So maybe Ivan, you want to speak to that.
Ivan Tornos:
Maybe I won't give too many details because you never know who's listening. But the facts are that penetration of Cementless associated with ROSA, is sort of the end of teams. The pull-through and a lot is going pointed of the Knee performance in Q1 is ROSA related. The 600 plus robots that we place roughly 50%, not 60% of those in the U.S. half of those are in competitive accounts, how we've seen meaningful revenue going from those areas. And all of that is in the early innings. As we get into the additional launches on Hip, as we getting through all their modalities of ROSA Knee. We've got $7 billion innovation pipeline. We got to continue to see a nice pull-through there. Cementless is one of the elements of our pull-through, as is regular knees. And then we have a disposable and another component, CVX many, many accounts and gets contracted as part of the ROSA placement or sale and that's another social revenue. So again, we don't disclose the revenue which were robots. But I will tell you that is above expectations so far.
Matthew O'Brien:
Thank you.
Bryan Hanson:
And Suky, sorry to step on here. But I figure that was more of a commercial discussion versus a financial one.
Suky Upadhyay:
Is that what you were going to ask?
Ivan Tornos:
[Indiscernible] or you want to change the answer here?
Keri Mattox:
Lauren, I think we are ready for the next question in the queue.
Operator:
Our next question comes from Ryan Zimmerman with BTIG.
Ryan Zimmerman:
Thanks for taking the questions. Good morning. A couple for me. When you think about '23 in the streets, I think modeling about 8, 3% growth or so. And there's a lot of puts and takes this quarter. We've now shed spine and dental. Bryan, when you think about the business segments, I mean, and the growth rates and the, was kind of asked this from a pacing perspective, but I'd love your perspective from a business segment perspective, what's accretive to growth? What's dilutive to growth now? When you look out on the business? I think we know the answer to this, it'd be helpful I think to walk through where you think the growth rates could be for knees and hips versus sat, etc? Then my second question I'll just ask it now. Suky, you may have spoken this before, but just help us understand any dis-synergy assumptions post-spin on ZimVie?
Bryan Hanson:
So, I'll start and then obviously you can transition to Suky. We're feeling really good actually. The funny thing is when you think about Knee, most people think about it and rightly so a pretty slow growth market. But in reality, there's more innovation entering the Knee space than we've ever seen before. We've got our, us, our competitors, all focused on data, robotics, and other forms of technology and share wallet opportunities that we just haven't seen in the past. So even though one might view that as a relatively slow growth market, I actually see it as a real potential to see some acceleration in that market growth. I feel very confident that we can grow well because of all the shots on goal that we have. I also think all boats will float here. I mean, it's really great because you've got a lot of technology entering the space. What we've seen is that it's being digested. When I think about that, what are the implications? You've got the same number of procedures being done, but you're getting more share of wallet for every procedure that drives up the entire space. Usually when you bring innovation as Ivan was alluded to earlier, when you have vitality in a space that also drives better pricing stability. Because you signed longer-term contracts when somebody converts, for instance, to ROSA, they usually come right back, you try to knock it down from a pricing perspective. So, vitality really does drive stability and pricing as well. So, I think even in a space like that, that you might not believe would be attractive for overall revenue growth, I do believe it is sustainably an attractive area for us to invest in growth. And it's very profitable for us as well. Set is pretty obvious. The categories are set that we're concentrating on are attractive market growth that everybody knows. We believe we have an ability to win and we'll continue to scale in those areas. So pretty much across the board when I look at large joints score set, I see them as attractive markets given the technology and innovation that we're bringing to bear.
Bryan Hanson:
Suky?
Suky Upadhyay:
Yes. And hey, Ryan. On your question related to the spin and I believe it was on this synergy. So, if you look at the re - casted financials that we put out last week, you would see that overall, we see operating margin accretion of about a 190 basis points from the transaction, which is a little bit better than our original expectations, that's a good thing, of further validation of why we entered into that transaction. Inside of that, that would then imply and suggest about $40 million to $50 million of stranded costs remaining with Zimmer Biomet. I would say that we're already making progress against those stranded costs this year. We believe that there's more opportunity going into next year and we kind of just see that as part of our overall operating base as a potential source of opportunity for future efficiency. Hopefully that gets to your question on where we see and how we size the synergies. but make no mistake about it, we're going after those as aggressively as we can while ensuring we don't disrupt the business and the recovery that we're starting to see.
Ryan Zimmerman:
Thank you.
Keri Mattox:
Thanks, Ryan. Lauren, we have another question in the queue.
Operator:
Our next question comes from Mike Matson with Needham and Company.
Mike Matson:
Good morning. Thanks for taking my questions. I wanted to ask one on Persona IQ. I know you made some brief comments on it, but maybe you can give us more detailed update on the launch. And then is this something that could be material to your Knee growth this year or next year in terms of adding 100-plus basis points in Knee growth?
Bryan Hanson:
Yes. So, we're lucky to have Ivan on the call today because obviously, I'm close to this. He is extremely close to Persona IQ, not just what we have in Knee, but also the future view of where we can take IQ and smart implants. But I would say we're in limited launch, as we've said, we're going to do this right. We're going to take our time, we're going to make sure that we learn what we need to learn just so that when we do full launch, we launch well. But the early stage of this is very attractive. What's interesting about it, he's going to get into IQ itself, what's interesting about it is it's also driving traction for the organization just because it's innovative. Even people that are not ready for IQ yet, they're just saying, ''Hey, I'm not quite ready for it yet.'' They're looking at us as -- differently. They're looking at Zimmer Biomet as an innovative player in the space, and most people want to be linked to an innovative player, someone who's going to change the space. And so even those customers that didn't want to come to us for IQ, we're getting interest for them just to move to regular Persona. So, it's almost got a halo effect because it's so unique in the marketplace. But yeah.
Ivan Tornos:
Absolutely yeah, Mike. So, first thing is first, we're on track with our limited market release. I'm not a friend of the wind limit their market releases; I'd like to do full force launches. But on this one, given the complexity and given the disruption in the market, we wanted to go slowly and collect data. The -- I won't talk about the number of hospitals that have been on-boarded but it is significant. The base in pipeline is also significant on both expectations. We collect the data across the board on mobility, range of motion. We've had literally thousands of base plan data track. The platform Persona IQ is now fully integrated. We found our mobility and the rest of the CDA ecosystem. We have not seen any surprises when it goes to the qualified data that we tracking. Most excitingly, we've got a technology road map that is going to go beyond knees. Already got the sign agreements for us. I mean, this for shoulder and other categories. On the second part of your question, I'm not going to comment on what it is material or not. I will tell you this, material for patients. And then the logic shall prevail if it is material for patients. So far so good, very excited. I look forward to the next steps.
Mike Matson:
Okay. Thanks. And then just as a follow-up, I wanted ask one on ASC. So how do you feel your position competitively in ASC sector? And do you think your growth in ASC was faster than your growth in hospitals? I mean, it seems like it is for the overall market, I guess from what we've heard, but --
Ivan Tornos:
Yes, I can take that one as well. So pleased with where we are, we [Indiscernible] ASC. Clearly, we started later than others in this environment, given our strong position in hospital settings, inpatient, outpatient and whatnot. But we put a plan together to get around 40 components, making sure we have the right portfolio, the right people, the right partnerships, and the right contracts on the products we don't have ton. We fill the gaps on basic things like [Indiscernible] on the 20 cities from [Indiscernible]. We launched that ASC friendly innovation around robotics. We have increased our Cementless penetration. So, I think that the portfolio is a second too, especially now that we added these ports made on [Indiscernible], so strong on the product angle. On the people aspect, we didn't use to have a dedicated, a structure, dedicated commercial structure, and contracting a structure on the ASC setting. We have it now, is fully dedicated. We got a large group of people that each and every day get up, and seem volume about the ASC. On the partnership angle, we got those key relationships with [Indiscernible] in the US, we developing technology together that is applicable to the ASC. We done a ton of medical allocation, together we found this key centers. I mean, around contract in his Meta date, we got an owner of all ASC contracts. We're very disciplined around the governance in those relationships, particularly in pricing. So, I think the plan is working well. We're growing faster than expected, I'm not sure these days was growing faster or not than the others. The ASC performance in Q1 was above our expectations, and as we think about the rest of the year, I think we're in good position to continue to grow.
Mike Matson:
Great. Thank you.
Keri Mattox:
Lauren, I think we have time for maybe one or two final questions.
Operator:
We'll take our next question from Robbie Marcus with JPMorgan.
Robert Marcus:
Great. Thanks for taking the question. Maybe I could ask the S.E.T. business was the slowest grower this quarter, it's 25% of sales. And we don't get geographic breakout or segments there. I was hoping if you could walk us through sort of the different components and any geographic differences to point out. Just given that a lot of your competitors called out extremities and sports medicine as positives this quarter. Thanks.
Bryan Hanson:
Maybe also get a chance some of this, Ivan. But the fact is we did have a pretty significant headwind. So, you look at the difference in regions that the most challenging region that we had was Asia-Pacific and a big part of that as we all know, is the trauma, VBP and the weight that that's having on the overall segment. Outside of that, when we looking inside of S.E.T., I would say the same thing. Our upper extremities business did very well. The innovation is helping us drive our performance there, but also the focus that we have. Sports did very well as Ivan talked about before, and that happening both U.S. and Europe. And when you think about our CMFT business, we continue to see traction there, not just because of the acquisitions that we've had, but also because of the now, what I would define as organic growth from those acquisitions. And again, the focus that we have, commercial in CMFT. So those are kind of the bright spots that we have, and those are across all regions. The big headwind for us is in trauma, a lot of that being in Asia-Pacific.
Ivan Tornos:
I guess, if I had to add to what Bryan is saying, I'll be saying the same thing with a different action. I want to extend myself, but that it started about the dedicated channel in key geographies in Europe and the U.S. primarily and the innovation that is coming later in the year and going into 2023. Sports is going well; extremity is going well. Again, some knows [Indiscernible] trauma, but two of the three key components are performing very nicely and they love to perform even at a faster basis. Thanks, Robbie.
Robert Marcus:
And are you guys willing to give any ex-China growth rates for extremities and trauma?
Bryan Hanson:
I think you could probably just read from what Suky said and -- I think it was in your prepared remarks, Suky, but 200-300 basis points of headwind is what you could look at in the quarter on the global business as a result of China.
Robert Marcus:
Great. And maybe just one quick follow-up for me. As you think about China, that is a country with the difficult pathway forward with the no COVID policy. I just want to make sure, are you assuming continued pressure from lockdowns through the rest of the year or are you assuming that it resolves in the near-term? Thanks a lot.
Ivan Tornos:
Yeah. The reason for the range that we have in the guidance is to make sure that we're accommodating risk core opportunity in places like China. So, it's already calculated in the range that we have. What I would tell you is, again, within a little bit lucky there, sometimes it's okay to be lucky rather than always just good. But the fact is we've had that offset. We have had some pressure when we look at Shanghai lockdowns, but we've also had delays and BPP implementation which helps us from a pricing standpoint and they've offset each other. And so, at this point in time, even though the mix of how we're getting to the revenue and the bottom line that we assumed we would get in China it's changed, but the overall impact is about where we thought it would be. So, I guess all that to say, even if we see continued lockdowns, as long as we see continued delays in VBP, they seem to be offsetting each up.
Keri Mattox:
Thanks, Robbie. I think we're at 9:30, so we probably need to wrap there. Lauren, thank you so much. Bryan, don't know if there's any closing remarks from you or any other members of the team, applies there just to see if you'd like to make any comments before we wrap up on this end.
Bryan Hanson:
No, I think the nice thing is we've captured a lot of what we wanted to say via the questions. The fact is it was a good quarter. It feels good to have and I think probably the most important thing, even though there's a lot of challenges that everyone is talking about right now, that we're going to have to deal with it. We're going to have to manage through and have confidence in the team can managed through those. The difference now is it's the same challenges for everybody where we've been disproportionately impacted by COVID. If I had to select, I would take the challenges that we currently have in place and their impact to the business versus continued COVID impact. That's the positive for us. That's been kind of a light at the end of the tunnel that we've been waiting for, which is COVID receding. And I truly do believe if it does receding and it continues to recede, that the actual performance that we see in the business will begin to be reflected in the performance that you see in business. With that, we'll go ahead and end the call.
Keri Mattox:
Thanks, Bryan. Thanks everyone for joining. Of course, if you have any other questions, please feel free to reach out to the IR team at any point.
Operator:
Thank you again for participating in today's conference call. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet Fourth Quarter 2021 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today, February 7, 2022. [Operator Instructions] I would now like to turn the conference over to Keri Mattox, Senior Vice President, Investor Relations and Chief Communications Officer. Please go ahead.
Keri Mattox:
Thank you, operator, and good morning, everyone. I hope you are all well and safe. Welcome to Zimmer Biomet's fourth quarter 2021 earnings conference call. Joining me today are Bryan Hanson, our Chairman, President and CEO; and EVP and CFO, Suky Upadhyay. Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by the forward-looking statements due to a variety of risks and uncertainties. Please note, we assume no obligation to update these forward-looking statements even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties in addition to the inherent limitations of such forward-looking statements. Additionally, the discussions on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within our Q4 earnings release, which can be found on our website, zimmerbiomet.com. With that, I'll now turn the call over to Bryan. Bryan?
Bryan Hanson:
All right. Great. Thanks, Keri, and thanks, everyone, for joining us this morning. I'm going to just give you an outline of how we want the call to proceed this morning. I'm going to spend the first part of the discussion briefly talking about our fourth quarter results, and I'm also going to spend a little bit of time talking about what we're seeing so far in 2022. I know it's early, but I want to give you a sense of what we're seeing already and then just speak more broadly about our views of 2022 as a whole. And then I'm going to turn it over to Suky, who's going to provide more detail on fourth quarter; and obviously, more detail on our guidance going forward. And then finally, it will come back to me before we move to Q&A. I just got a few things I want to close out the prepared remarks with, and then we'll again jump into Q&A. Okay. So first, let's start with Q4, and I'm going to break this into really three categories. The first will be around COVID impact in Q4 and how it compared to our expectations. The second will be around VBP impact and again, how that compared to our expectations. And then finally, just performance outside of those environmental impacts and how we performed there. Okay. So let's take a step back first. I think that will help. Just when we gave our updated Q4 guidance on our Q3 earnings call back in November, we actually outlined our expectations around how COVID and staffing pressure would likely impact our fourth quarter results, and unfortunately our assumptions largely played out in the quarter. As you probably remember, we felt that the pressure from the end of Q3 would continue into Q4. And thus, the overall pressure from COVID and staffing would actually accelerate from Q3 to Q4. And really, the big reason this played out, of course, we know now is because of the Omicron surge that occurred towards the end of the fourth quarter. And as many have already stated, a lot of that impact truly came in December itself. So, what's interesting about this surge, though, is that even though the overall impact of COVID was about what we expected, the way it manifested was different, right? So, ICU capacity was definitely a factor, but we did not see it as the primary driver of cancellations of procedures during the quarter. And so, what we actually saw was more cancellations that occurred due to really either the patient or staffing member being diagnosed with COVID or actually having been around someone with COVID, and they were quarantining as a result and couldn't show up for the procedure. So that was really the shift that we saw in the quarter. So, the overall impact was about what we expected, but the way, again, it manifested in the numbers was slightly different. Okay, so transitioning from there to VBP. Remember again on our Q3 call, we discussed what we thought the impact of China hip and knee VBP would be in our fourth quarter results. And we actually - we were largely right on how that played out. And so, our expected headwind in large joints was in line with the expectations that we had and also what we communicated to you. So that was pretty much in check when we think about large joints. Now what changed during the quarter, actually even post the quarter was that on January 24, the Chinese government announced that it was formally nationalizing one of its provincial trauma VBP tenders, and that was kind of new to us. But based on that confirmation from the Chinese government and really just our knowledge of how the VBP process will work from here, we did take a sales reserve in the fourth quarter, which obviously results then in a negative Q4 impact to both our net sales and adjusted diluted EPS. And what I'd say is that even though this trauma VBP adjustment came earlier than we anticipated, it is pretty consistent with the overall scale of the impact and consistent with our expectations and what we've been talking about more recently. Now, I would say looking forward, the good news is we have a lot more visibility now. We're a lot smarter on the topic, and we understand what the impact of VBP will now be on our 2022 business. And that has been included in our guidance, which Suky's going to talk about in just a minute. Okay, so now looking past VBP and COVID in the fourth quarter, I'm very proud of the team when we focus on the things we can control. ZB's business execution against the challenging backdrop has been strong. Our strength of our team right now, that’s kind of one ZB culture, is as evident as it's ever been, and I think more important than ever. And the team has really been able to move our strategy forward even in these challenging times. And a few proof points to be able to point at, the team was able to drive continued strong demand and momentum for ROSA, and that is globally, not just in the U.S. but globally. We actually more than doubled the number of installed ROSAs in 2021 versus our cumulative total at the end of 2020. That's a pretty significant jump up, and again, speaks to the momentum that we have in robotics and orthopedics. And those ROSAs are paying off. In the fourth quarter, those installed ROSAs allowed us to reach 10% in total knee procedure penetration in the U.S. for the first time as a company. That's a huge milestone for the organization, and it's just the beginning of this ROSA journey for us. The team also delivered a successful limited launch of the world's first and really only smart knee, the Persona iQ. Now it's early. Obviously, early days. We're in limited launch right now, as I said. But the launch trajectory feels great. The feedback is good, and we're looking forward to a full launch later this year. And then finally, and I think importantly, the team continues to execute in large joints across the board, driving again above-market performance in Q4 in the U.S. for both knees and hips versus 2019. Okay. So, let's transition from Q4 and talk about what we're seeing so far in early 2022. And I'm going to speak specifically about COVID and staffing challenges. What I would tell you is that the challenges that we saw in Q4, in particular in December, are unfortunately continuing into January. And as a practice, and I think prudently so, our team is continuing to build our financial models using what I'm going to call a recency bias in those models. And as a result of that, we're expecting that December and really now January pressure in COVID and staffing will continue through Q1. So, what we're basically saying is that overall, we anticipate that Q1 will likely be more pressured than Q4 was. And so what does that mean for our outlook for the full year? Again, we're going to follow that same approach. We're going to look at 2022 in a similar way, actually, in a very similar way in the way we gave guidance for Q4 of 2021. Until we see a fundamental shift in the current state and what's happening today in the environment, we are projecting that the COVID pressure will continue throughout the year and will be -- actually follow a similar peak and valley trend that we saw in 2021. As I'm sure you can appreciate, given that about 80% of our revenues come from elective procedures, ZB must be highly attuned to this topic. And trust me, we are. We're highly focused in this area, and that has been captured in our assumptions for guidance. And with that, I'm going to transition to Suky to give you again more detail on Q4 and also our 2022 guidance. Okay, Suky?
Suky Upadhyay:
Thanks, and good morning, everyone. For this morning's call, I'm going to focus on 3 topics
Operator:
Thank you. We'll take our first question from Josh Jennings with Cowen.
JoshJennings:
Good morning, thanks, for taking the questions. Just wanted to start off on '22 -- 2022 revenue guidance and just make sure I understand the impact of VBP that you're baking into the range. I know you don't usually break out guidance for specific regions. But anything you can do to just help us think about what's baked in for Americas and EMEA versus Asia Pac into that down 4 to flat on a constant currency basis for 2022? And then just as a follow-up on the operating margin guidance, just the trajectory. I know as these pressures are in play, you've taken another look at that in that 30% target. But just as you're moving through these transformation programs and looking at regional profitability, infrastructure in smaller markets and other areas of cost reductions, I mean, how do you balance that with the top line growth projections? Is there any risk that you're going to be impacting revenue growth over the next couple of years by pursuing these transformation programs? Thanks for taking the questions.
BryanHanson:
Yes. Maybe, I'll just start real quick on that last portion of it, and then I'll pass it over to you, Suky. We actually feel more confident in our ability to invest for growth in the business because of the transformation programs. The transformation programs are not specifically associated with R&D and investment in those key growth drivers for us. They're more focused on finding efficiencies that do not impact our ability to spend in those growth areas. So they really actually bring more confidence that we'll be able to spend on the things that are actually going to drive growth in the future. But outside of that, I'm going to push it over to you for the other questions.
SukyUpadhyay:
Yes. So Josh, thanks for the question. Regarding revenue guidance, so we talked some of the overarching assumptions in that guide on negative 2 to 2 on an ex-FX basis for the full year revenue is really around the concept of we expect COVID to continue for the full year and the impact of COVID on elective procedures and staffing shortages, again, to really be with us for the entirety of 2022. Now what we're saying is, broadly, we would expect to see procedural volumes consistent with 2021. And that's in the backdrop of COVID actually accelerating in the first quarter, right, where we expect the first quarter on an underlying basis to be down. So, we do expect to see some recovery in the later quarters within the year. Specifically, inside of that, the your question to VBP, we don't see VBP as a material headwind or tailwind at this time relative to large joints or trauma, given the charges that we've taken in the fourth quarter of 2021. Now, I would say that the cadence of that by quarter is going to be definitely different, even though it's not a full year headwind or tailwind. It will definitely be more pressured in the first half of the year than in the second half of the year. So that's how we think about VBP. Now I think your other question was regarding how do we see regional performance in that flattish growth. We're not going to comment on regional color at this time. There's a lot more that's got to play out relative to COVID and the recovery by region before we're going to talk about that. So, we'll give you more color as we get into the -- further into the first quarter on our first quarter call. But right now, consolidated level, we expect it at our midpoint to be about flat.
JoshJennings:
Great, Thanks for the detail.
Operator:
Our next question comes from Vijay Kumar with Evercore ISI.
VijayKumar:
Hi, guys. Thanks for taking the question. My first one, Suky, is on the EPS guidance here. The base of Zimmer, right, ex the spin, I just want to make sure I have the right numbers. I'm getting to maybe something [indiscernible] $0.13 of earnings in 2019, 665 (ph) earnings on a comparable basis for the last year, fiscal '21. One, can you just walk us through the bridge [Technical difficulty] fiscal '22 guidance of 650 at the midpoint? What is the cause of line from '19 perhaps volumes maybe [Technical difficulty]
BryanHanson:
Vijay, I'm sorry to interrupt, but you're a little staccato. You're not coming in really well so we can't capture your question. I don't know if -- maybe if you can go on, if you're on a speaker, something, maybe you can change it. We can't hear you really well.
KeriMattox:
Yes, Vijay, it sounds like your line is just not a good connection. Maybe you can get back in the queue. Sorry about that.
BryanHanson:
Are you still there?
VijayKumar:
Yes. Sorry, guys. Can you hear me now?
KeriMattox:
Much better. Go ahead.
VijayKumar:
Yes. Apologies for the bad connection. But Suky, maybe on just EPS guidance, what is the comparable earnings in fiscal '19 and '21? I'm getting to 714 of earnings or 715 [indiscernible] 660 in '21. Maybe walk us through the bridge from '19 what caused the declines? And year-on-year versus '21, the guide implies flattish earnings, that bridge would be helpful.
SukyUpadhyay:
Yes, sure. So, thanks for the question, Vijay. So first of all, I'm not really going to bridge back to 2019. By the time we get through 2022, we'll effectively be in 3 years removed from that in an COVID environment. So, it's really difficult to draw a lot of comparisons. But here's how I would think about how we arrived at our operating margin and our guide ultimately for EPS. And so, if you use 2021 as a starting point, we ended the year at 26% on adjusted operating margins. From there, we've got some tailwinds and some headwinds. Starting with the headwinds. We have been talking about incremental pressure coming in to 2022 really from 2 dynamics. One was the China VBP, and while the overall revenue impact will be roughly the same as what we saw in 2021, there is a greater margin impact in 2022 because the composition of that revenue downside between the years is a little bit different. The second headwind that we're seeing is really around inflationary input costs. Things like energy costs, metals, labor, freight, these are definitely being impacted and felt within our company. So if you put those 2 things together, that's roughly about 100 basis points, maybe slightly more. So using our '21 exit of 26% and those headwinds, you would normally arrive at about a 25% adjusted operating margin for 2022. However, we do have some tailwinds. We have the spin. And as we've talked about, prior to the spin, we said that, that would be about 125 basis points accretive to operating margins. It's actually a little bit higher, more like 150 basis points even after netting out stranded costs. And then we have another element. We've been deploying some additional restructuring activities within the company because of the continued pressure of COVID. That's going to be a tailwind of about 50 basis points. So when you add that spin accretion plus the other efficiency programs of 50 basis points, that's what gets you from an underlying 25% operating margin in 2022 up to a 27% at our midpoint. So hopefully, that gives you the big building blocks. Again, headwinds being VBP and input costs, tailwinds being spin and other efficiency.
VijayKumar:
That's helpful, Suky. Just one last one. What are you assuming for TSA revenues? I understand the stranded cost, I think, $70 million, $75 million-ish. Are there any offset from TSA that's being assumed in the guide?
SukyUpadhyay:
Yes. We will get some TSA income. We're structuring those pretty much on a cost -- with a slight cost plus. But because we do not see them as core to our business or recurring, we're actually going to be non-GAAP-ing that benefit. So we do not have any benefit in our earnings per share related to TSA income.
VijayKumar:
So just -- I mean, TSA should be equal to the stranded cost rate, 75-ish, Suky?
SukyUpadhyay:
I wouldn't say it's a complete 1 for 1 there, Vijay. It will be substantially lower than those stranded costs.
Operator:
Our next question comes from Robbie Marcus with JPMorgan.
RobbieMarcus:
Great. Two for me. Maybe I'll just ask them both upfront. One, as it relates to the guide, you sort of touched on this, it's flat at the midpoint in a COVID environment. Bryan, should we be thinking that closer to that mid-single-digit growth is off the table as long as a COVID environment still exists? And then second question, as I think about RemainCo, how do we think about it if there's any way to give us before the full pro formas are out. Gross margin was a bit disappointing in the quarter. How do we think about the components of operating margin in 2022? Is it much more SG&A-driven? Or are there gross margin improvements as well?
BryanHanson:
Great. Okay. So I'll start with the question around COVID and our growth rate. And I think it would probably be pretty obvious to most. If we continue to see COVID pressure and staffing pressure kind of at the rate that we're seeing today, yes, it would be very challenging, obviously, for the company to get to mid-single digits. That wouldn't be something that we think is possible in an intense COVID environment. What we do believe is when COVID gets behind us that we absolutely have the building blocks to get there. But in a COVID environment, just given the pressure on elective procedures and given the fact that we have 80% of our revenue built into those elective procedures, it's just not a pathway to get there.
SukyUpadhyay:
And Robbie, on your question related to the composition of the 27% adjusted operating margin or midpoint, it's going to be primarily driven by SG&A. The way we see overall gross margin is, as we talked about in the prepared remarks, we ended 2021 at or about our guide, which was roughly in line with the back half of 2020, so just below 71%. From there into 2022 on adjusted gross margins, you've got, of course, some headwinds, tailwinds. The headwinds being the VBP margin pressure I just spoke about with Vijay as well as the input cost inflation that we're seeing, again, that I just talked about. In addition, lower volumes will also be a slight headwind. Those will be partially offset by some accretion that we see related to the spin. But net-net, I would expect gross margins year-over-year from '21 to '22 to be down. So the bulk of our improvement in adjusted operating margins from '21 into '22, again, will be primarily driven through SG&A.
Operator:
Our next question comes from Steven Lichtman with Oppenheimer & Company. .
StevenLichtman:
Bryan, on ROSA, I was wondering if you could talk a little bit about the pipeline you see ahead. How are you seeing '22 placement opportunities versus '21? And where are we in terms of the build out of the opportunity to pull through of knee implants following those ROSA placements?
BryanHanson:
Yes. So the -- I would say that the pipeline is really strong. I mean that's one of the things that has been a positive surprise during this COVID pressure. There has not been a reduction in demand on robotics, which is, to be honest, when we first started, I thought it would be the case, but we just haven't seen it. We've seen continued pipeline gets stronger. And what we're finding is that, that pull-through is already happening. We always talk about are we placing robotic systems in a competitive account or a friendly account. What I always go back to is every account for the most part has some competitive flavor to it. It's not always homogeneous. So even in those accounts that we would consider our platinum accounts, when we place a capital system there, a ROSA system there, we absolutely have an opportunity to convert a competitive surgeon because there will be a competitive surgeon that exists in that platinum account. So that's what's exciting about it is the demand is strong. We continue to see it move in the right direction, and that pull-through is already happening. A big proof point to that is just the fact that in the U.S., we reached that 10% of total knees being done robotically. It doesn't sound like much because I know one of our competitors is much further along than that. But that feels like a pretty good start. And the fact is it's just the beginning of the journey. So yes, so the demand is strong, and I would tell you that the pull-through is real, and it's continuing.
StevenLichtman:
Great. And then just a follow-up on cash. You're clear on the debt pay down expectations near term. Will M&A be muted as a result? Do you still see opportunities for tuck-in deals?
BryanHanson:
Yes. Unfortunately, as we get into the Phase III of our transformation, a big part of Phase III, as we've always talked about, is active portfolio management. And COVID has definitely put a dent in our ability to leverage as much cash as we were hoping to leverage to move that forward. At the same time, even in a pretty cash-constrained environment, we've done a good job of continuing our strategy there. As I mentioned in my prepared remarks, we've done a number of deals, either M&A or partnerships, to ensure that we're building scale in those important faster-growth areas. But we just have not had the amount of firepower we would like, and certainly that pressure is going to continue.
Operator:
Our next question comes from Larry Biegelsen with Wells Fargo.
LarryBiegelsen:
Bryan, just 2 for me, one on Persona iQ, one on the ASC strategy. Can you talk about what impact you expect Persona iQ to have to revenue in 2022? And the pricing strategy, just remind us again of kind of if you -- well, if you're planning to resubmit for the new tech add-on payment. And if not, why? And then just second on the ASC strategy. Just talk -- you've talked about being under-indexed there. What's the plan to change that? And can you grow at or above market in recon before you address this? Or will it be a headwind to growth in the near term?
BryanHanson:
Sure. So maybe I'll start with the ASC. And believe me, we are already shifting our focus here. We had planned to do it anyway. But obviously, with the results of COVID and pushing more patients to the ASC, we put that plan on steroids. We built a, I guess, first and foremost, a direct selling organization to ensure that we're contracting effectively in that setting. That was almost 0 to 100 people in a relatively short period of time fully dedicated to contracting in the ASC setting. That was probably the first big step. Also driving compensation, right? So operating mechanisms to drive focus there and also compensation to drive focus there. The other thing that we're doing is to make sure that we're filling our product gaps that will give us more presence inside the ASC. That would be like the Relign acquisition in sports, where we had that gap in capital, would be like Incisive where we got booms and lights to be able to give more infrastructure to the ASC. So those are the things that we're doing right now to be able to get further traction in the ASC, and we're making progress. Do we have more work to do? There's no question. But when I look at our growth in the ASC and I look at our expanding size of our business in ASC, I know that what we're doing today is actually working. So that's ASC. On the iQ side, I'll hit maybe the reimbursement question first. We're going to pursue everything we possibly can to try to get incremental reimbursement, but we're not counting on any of it. So our plan today assumes no incremental reimbursement that this would be captured under the DRG that exists today. And that even in that, we've built a plan that we think is very favorable to the company. And from a revenue standpoint, maybe you can take a step back, iQ really helps us in what I'm going to define as 3 different ways. One is the obvious revenue contribution that we can get. And that can come through a mix benefit because it's going to be a higher-priced item versus a standard implant. But it can also come from competitive conversions. Now that's going to be biased to the back half, that revenue impact because we're not going to move to full launch until the back half, but revenue is clearly one of the variables that are going to help us with iQ. Second one is brand reputation, and this matters. This is going to be able to solidify the fact that we are an innovator in our space. And this matters even if a surgeon is not ready for iQ yet. They want to be married, if you will, to a company that's going to be a leader from an innovation standpoint in their space. So it does matter when people are making decisions on who they're going to be linked to whether you're innovative or not. So that brand reputation is important to us. And the third one is differentiation. This is going to help us differentiate our ZBEdge ecosystem, that robotics and data ecosystem. I truly do believe that robotics decisions from our customers will be influenced by the ecosystem around robotics, not just robotics by itself. Remember, robotics just does what you tell it. The data collection will eventually tell you what you should do. And then the robotic system could do it for you. We would just make sure that you deliver on it. So that's the way I think about the impact of iQ, not just revenue, but brand reputation and differentiation as well.
Operator:
Next question comes from Matt Taylor with UBS.
MattTaylor:
So I wanted to ask one about operating margins longer term. Obviously, you changed the timing of the '23 goal. Could you just talk about the trajectory of margins that you foresee occurring with your forward outlook? And Suky, I know you've talked about margins as being largely revenue dependent. Maybe talk about the importance of revenue growth for driving margins higher and then also some of the things that you're doing with regards to regional profitability and ERP and how those can play into margin growth going forward as well?
SukyUpadhyay:
Yes, sure. So thanks, Matt, for the question. You're right. We did remove our 30% target by the end of '23 because of the ongoing challenges of COVID and the lack of revenue growth. And if you recall, that margin was largely predicated on 3 building blocks. One of the main one was revenue growth, which obviously we're just not seeing come through as we've been talking about. I think longer term, we still do have the opportunity in the near term to expand margins. We're not going to size that at this time because we do still think it's largely going to be revenue dependent because we have to balance in the mix of efficiency that we're seeing across the company and that we're driving forward with the right level of investment against the business for long-term growth because we do see COVID eventually it's temporal. And we want to make sure that we can continue to invest against the very strong pipeline we have in commercial execution to make sure that we can grow value over time not only in a pandemic world, but most importantly, in the post-pandemic world. Some of the key drivers that I would say beyond revenue growth that can help drive margin expansion in the near term is our establishment of global business services or large shared service regional centers, which we planned for in 2020 and actually implemented in '21. That's going to be a key component of that incremental margin expansion I talked about in '22. But then beyond that, the ability to leverage those beachheads are going to be important. You're right, we're making investments into ERP. Those are generally longer term in nature to actually play through and to get those benefits. So I would see that those benefits coming in post 2023. In addition, we continue to look at and our supply chain is always looking at opportunities to optimize and rationalize our overall manufacturing footprint, but also to continue to combat input cost rises through very aggressive procurement. So those are some of the levers I would think of as in the near term in the absence of revenue growth, but no doubt revenue growth is going to be the key driver to meaningful margin expansion over the mid and long term.
Operator:
Our next question comes from Rick Wise with Stifel.
RickWise:
Maybe going back to COVID. Again, it's hard to ask this question because I know there's a million moving pieces. But as you're reflecting on the sort of early headlines of COVID headwinds clearly easing in the Northeast, I mean, new cases are down dramatically. How are you thinking about how the recovery, the post-COVID recovery unfolds relative to backlog and sort of delayed procedure volumes? Just how are you thinking about it now as you see the reality start to unfold?
BryanHanson:
Yes. So I'll give you a sense of how we built it into our forecast and the guidance that Suky just referenced. We actually try not to get too caught up into this whole concept of the cases are dropping from a COVID standpoint because we're still seeing cancellations that are as high as we've seen in a long time. And so there seems to be other reasons, as I referenced in the prepared remarks, on why we're seeing cancellations versus just ICU beds being taken up by COVID patients. So we really, at this point, are assuming that the 2022 impact from COVID will look a lot like the '21. Maybe different timing of peaks and valleys, but we expect at this point until we see something that tells us that it's going to be different that you're going to continue to see a peak come down like we're seeing now, and then it's going to go right back up given the new variant. That's the assumption that we have throughout 2022. Now if we set that assumption aside, and we say that we see a peak come down into a valley, if you will, and it never comes back, then that -- completely different game. That gives us an opportunity then to get back to those growth rates that we're seeing back in Q4 2019. Remember, those growth rates we saw back in Q4 2019 about 3.2% or so, that was really before Vitality index was picking up for us. That was just on the beginning of that Vitality index moving north. So that would be an exciting environment for us. There's no question about it. But just know that what we built into our guidance is that '22 from an overall impact standpoint is going to look a lot like '21 when it comes to COVID and staffing pressures.
RickWise:
Got you. And on ROSA, again, I mean, clearly, you had a terrific year despite some of the challenges. Where are we with the partial knee rollout? Where are we with the hip rollout both launched last year? And maybe as part of your comment, Bryan, about the new product pipeline being stronger than ever, I don't know whether there's a ROSA component there. What's next? What's coming? What are your priorities now to keep this momentum going?
BryanHanson:
Yes. So ROSA overall, as I've said before, our primary knee is going really well. The pipeline is as strong as it's been. The pull-through is there. The penetration in our overall procedures is coming up, moving in the direction that we had hoped. I think it will leave and unlock more value when COVID subsides because that is obviously impacting our ability to get procedures even in those accounts where we have ROSA, but it's definitely moving in the right direction. Partial is the same thing. I'll just step back there, too. The partial knee application was important one for us because I think as most people know, we have a very high market share position in partial knee. So to be able to bring a robotic platform with that application is really important for us, and we have a lot of opportunity then to go to those accounts that are using our partial knee and try to move them to robotics. And the hip is going well, too. It's really kind of a combination of ROSA Hip and Avenir Complete. One of the fastest growth subcategories of hip, I think everybody knows now, is direct anterior approach. And both of those, the Avenir Complete as well as the ROSA application that we launched first goes directly at that fast-growth submarket. Now later this year, we also have another application that we're going to launch in hip that will go after the posterior approach. So we'll have everything locked up from a hip standpoint. But those are the things that we're pretty excited about. Stepping back from that, just ROSA, I feel really good. I'm not going to get into a lot of the things we're launching that we haven't talked about already, but just some of the things we talked about a lot. Persona Revision, I mean, this is one that has been driving really strong growth for us for 2 years, and we expect that to continue. It's not just the Revision conversion. It's the universe of primary needs that are still competitive where they're using us for revision. We're going after that business, and there's a real opportunity, again, in the hundreds of millions of dollars for us. And then when you look at outside of ROSA, iQ. We're just getting started up Persona iQ, and I talked about the 3 different ways that can bring value. I absolutely expect that to be a true provider of revenue for us. And the ZBEdge just in total. ZBEdge is getting a lot of traction. It's creating brand awareness for this company to be a leading-edge organization, and that does drive revenue growth for us. So those are just a few of the things that we have that we're excited about. And we talked about it, so I'll talk about it again. We have a cementless Persona coming that has a different form factor. They should remove all stops for us to be able to move cementless forward. That has been nascent for us. It's a real opportunity. We're below 10% penetration in cementless, but we have all kinds of headroom associated with that. And that new form factor coming later this year will open that door as well. So a lot to be excited about for sure. As I referenced before, the pipeline is strong, and we expect our Vitality index to continue to move in the right direction.
Operator:
Our next question comes from Chris Pasquale with Guggenheim.
ChrisPasquale:
Suky, I want to start just following up on the VBP impact to make sure we're thinking about this right. Are you saying that the dollar impact is going to be the same in '22 versus '21 across hips and knees, and now trauma is included in that as well. But it's just going to be spread out differently throughout the year. And maybe just help us with how the impact was recognized in '21. Did you have anything in the third quarter? Is it really all packed into the fourth quarter?
SukyUpadhyay:
Yes. Good question. So we do see, to your first point, overall, the revenue impact, top line impact against recon or large joints and trauma being roughly about the same year-over-year. So again, no material headwind, tailwind based on where we stand today. The impact, I said, will be different by quarter. So you really didn't have any impact in Q1 to Q2 of 2021. And so therefore, you've got pricing impact in the first half of this year, '22, which is being compared to a non-VBP first half of '21. So the pressure is going to be more acute on that year-over-year comparison. As you move to the second half, you had a modest level of impact in the third quarter around some inventory contraction, but not material. The really big impact was mostly in Q4. If you think about all the numbers that we provided to you today in some of our earlier commentary, it was worth roughly about 400 basis points of growth in the fourth quarter. So that's where you're going to feel the biggest impact in 2022. This year, it will be more of a tailwind for us because we won't have to cross over that one time that we took in '21. So again, sorry, Chris, a lot of numbers there, if there's that in any way, it's confusing. I can help clarify.
BryanHanson:
The one thing I will say from a dollar standpoint relative to revenue, there's that consistency and differences in quarterization of it, but that's consistent. But in margin, it will be more of a negative impact in 2022. And as Suky referenced before, about 50 bps of headwind for us and margin profile due to VBP in 2022.
ChrisPasquale:
That is helpful. And then, Bryan, I just wanted to follow up on the cementless opportunity. This was really alongside robotics. One of the things you guys were highlighting a few years ago is a significant potential mix driver for you across the hip and knee businesses. And it seems like it's gotten off to a much slower start here than we would have thought at that time. What was it about the prior Persona cementless that really didn't allow you to gain as much traction there as you were hoping? And how does this next version fix that?
BryanHanson:
Yes, it is that, actually. We -- again, we have a form factor that we felt confident with that was already kind of in the mix. But when we get it out there in the -- and surgeons look at it, they don't feel as comfortable with the design that we want on a go-forward basis. And remember, when you're talking cementless, you want to make sure that you really get good contact between the implant and the bone. And as a result of that, we've changed the design of that connection, if you will. And that talking to surgeons already about the design that's going to be coming, they have a lot more confidence in the safety of that connection. That's the reason why we changed the form factor. So it's not so much our inability to sell cementless in concert in particular with robotics, it's more around that form factor and the confidence people have in that form factor to get the feel that they're looking for. And we feel very confident about what we're going to be launching later this year. And again, I look at it to say as much as I'm frustrated by the fact that we have not had the right design, I know one is coming. And I'd probably rather be at the 10% now, and I think of future growth opportunities and be able to increase that penetration over time when we do launch that product.
Operator:
Our next question comes from Shagun Singh with RBC.
ShagunSingh:
I was just wondering if you can talk about trends exiting January and into early February, especially since the U.S. it appears to have occurred around January 13, even though there were regional variations and they continue to be. You did call out seeing more cancellations and also that COVID pressures will continue throughout the year. So I'm just trying to figure out if you can provide more color and if your guidance is realistic or conservative.
SukyUpadhyay:
Yes, Shagun. Thanks for the question. This is Suky. So as we said, we provided, I think, pretty good color on Q1, where we expect it to be about flattish, but that includes a 130 basis point tailwind from selling days. So on an underlying basis, it's really down year-over-year. January was definitely more pressure than what we saw in December exiting 2021. And we continue to see very high cancellation rates coming into the beginning part of February. So we think what we've seen so far continues to support that first quarter color that I talked about. And I think it's important to note that while Omicron cases maybe in some markets starting to -- people are characterizing that as plateauing, there is still a residual effect on staffing shortages, which, in some part, are linked to Omicron. But there are other factors that are driving staffing shortages. So just because we see a decrease in overall Omicron cases does not mean you're going to see a one-for-one reduction in staffing shortages, which continues to be a headwind for us. So short story, everything that we're seeing so far in January and the very beginning of February continues to support that first quarter call we provided.
SukyUpadhyay:
I got it. And then just one other question on operating margins. Maybe you can help us with the cadence if you haven't touched on it. And I'm especially curious with respect to the 150 basis points benefit from the spin. How should we think about the time line there for you to achieve that, especially given the context that you do have higher corporate cost allocations in the near term?
SukyUpadhyay:
Sure. So on the margin case, it's really -- our margin is very correlated and linked to revenue. And so as we said, revenue will be more pressured in the first half of the year versus the second half of the year, especially because of the pressure we're seeing in the first quarter. And so we would expect margins to follow that same cadence. It will be more pressured in the first half, most acutely in the first quarter not atypical from what we saw in 2021 regarding seasonality and the impact of COVID. So that's how we see the cadence of that operating margin, again, most acute down in Q1 and then recovery as we move through the rest of the year with revenue recovery as we talked about. Relative to the spin, I think you're going to see that 150 basis points start to manifest relatively quickly here in 2022. We have already started to attack some of those corporate stranded costs and are going to continue to fight our way through that. But that's how we see operating margins so far.
Operator:
We'll take our next question from Matt Miksic with Credit Suisse.
MattMiksic:
Just one question if I could on the strength in EMEA knees was one question that I thought would be worth flushing out if you have just a minute, and I'll just leave it at that.
BryanHanson:
Yes. I would just say that we see almost right now that EMEA seems to be ahead of schedule relative to what we're seeing in the U.S. and other parts of the world. I'm not sure why that is. But you did see some relief that we saw in EMEA because you did see a kind of that downward trend in Omicron. And also, you're seeing some policy shifts, which I think is going to be really important on a go-forward basis where you've got countries like the U.K. and Spain and others that are looking at this to say, "Listen, Omicron is acting more like an endemic phase now, and we're going to change some of our restrictions associated with COVID." And I think that those policy changes are going to be an important factor in COVID eventually getting behind us. It's not just COVID itself, but it's going to have to be these policy shifts that we're seeing kind of led right now by Europe. That would be something we'd like to see across the world actually. But that's the only thing I could probably point out is that just a little bit ahead of the curve in COVID impact than the rest of the world.
Operator:
That concludes today's question-and-answer session.
End ofQ&A:
Keri Mattox:
Yes. No, thank you. I think it was the last question. I can jump in here and just close out. So thank you, everybody, for joining. If you have questions that you didn't get asked or answered, please feel free to reach out to the IR team. I know we're speaking to many of you today, tomorrow and this week, but we're always available. Also, just a reminder that the ZimVie Investor Day is beginning at 11 a.m. Eastern Time. Information to join that webcast and the materials are posted on the IR page of our website. And of course, if you have any questions on that front, please feel free to reach out to the IR team as well. Thank you, everyone, for joining today, and have a good day.
Operator:
Thank you again for participating in today's conference call. You may now disconnect.
Operator:
Good morning, ladies and gentlemen and welcome to the Zimmer Biomet Third Quarter 2021 earnings conference call. If anyone needs assistance at any time during the conference, please press [Operator Instructions], as a reminder this conference is being recorded today, November 4th, 2021. Following today's presentation, there will be a question-and-answer session. At this time, all participants are in a listen-only mode. If you have a question, please press [Operator Instructions]. I would now like to turn the conference over to Keri Mattox, Senior Vice President. Didn't Investor Relations Chief Operating Officer, please go ahead.
Keri Mattox:
Thank you, operator. And good morning, everyone. I hope you are all well and safe. Welcome to Zimmer Biomet's Third Quarter 2021 Earnings Conference Call. Joining me today are Brian Hanson, our Chairman, President, and CEO, and EVP and CFO, Suky Upadhyay. Before we get started, I would like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by the forward-looking statements due to a variety of risks and uncertainties. Please note, we assume no obligation to update these forward-looking statements, even if actual results or future expectations change materially. Please, refer to our SEC filings for a detailed discussion of these risks and uncertainties, in addition to the inherent limitations of such forward-looking statements. Additionally, the discussions on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within our Q3 earnings release, which can be found on our website, zimmerbiomet.com. With that, I will now turn the call over to Bryan. Bryan.
Bryan Hanson :
All right. Great. Thanks, Keri, and thanks everyone for joining us this morning. Let me just start with the things that I'm happy about when it comes to Q3. First of all, I'm happy on our progress with our new product introductions, they're going quite well. Our execution on recent M&A is going as planned, if not better. Our commercial focus in our discipline is as good as I've seen it and I'm very happy with our growth versus our key competitors in both large joints and inset, particularly when it comes to the U.S. The team, in my view, continues to drive results in the areas under our control. And as a result, I continue to be proud of them for doing so. Alternatively, Q3 was also a quarter with unexpected negative environmental impacts, that are for the most part, out of our control. Q3 brought greater COVID pressure than I think anybody expected
Suky Upadhyay :
Thanks, Bryan. And good morning, everyone. I'm going to briefly discuss our Q3 results and updates that we've made to our full-year 2021 financial guidance. Moving forward, unless otherwise noted, my statements will be about Q3 '21 and how it compares to the same period in 2020. And my revenue and P&L commentary will be on a constant currency or adjusted basis. We've also provided comparisons to the third quarter of 2019, as we feel that performance to pre -pandemic results as an important comparator. Net sales in the third quarter were $1.924 billion, a reported decrease of 0.3% and a decrease of 0.8% on a constant currency basis. When compared to 2019, net sales increased 0.4%. On a consolidated basis, as Bryan mentioned, we were growing through August, but then declined in September, as we saw Delta variant cases and staffing shortage increases. In short, there was a seasonal step-up in procedural volumes for the quarter, but the recovery has not taken hold as fast as we thought it would, especially in our hip and knee businesses. The America's declined 3.2% or flat versus 2019. The U.S. declined 4.4% or up 0.1% versus 2019. Lower U.S. performance in September was the key driver to lower consolidated results. EMEA grew 5.9% or up 0.3% versus 2019. This is the first time the region posted positive growth since the start of the pandemic. In the quarter, we saw an improving trend across a number of markets -- however, the UK, France, Spain, and most emerging markets continue to be challenged, despite higher vaccination rates. Lastly, Asia-Pacific grew 0.5% or up 1.5% versus 2019. While we did see growth versus 2019, it decelerated versus what we observed in the first half of the year. This was driven in part by pricing adjustments [Indiscernible] channel inventory as we continue to negotiate with our distributor partners ahead of DBP implementation in tandem with continuing COVID pressure throughout the region, especially in Japan, and Australia, and New Zealand. Turning to business performance in the third quarter, the Global Knee business declined 0.7% or down 1% versus 2019. In the U.S., Knee declined 5.3% or down 0.7% versus '19. Our global Hip business declined 6.6% or down 2.4% versus 2019. And the U.S. Hips declined 11.3% or down 2.4% versus '19. The sports extremity and trauma category increased 4.2% or 7.7% versus 19 driven by continuing commercial specialization, new product introductions, and the contribution from strategic acquisitions we added to this portfolio in 2020. Our dental and spine category declined 6.1% were down 2% versus 2019, The dental business posted good growth in the quarter and continued to benefit from strong execution and market recovery, while the spine business declined when compared to 2020 and 2019, due to increase in COVID pressure throughout the quarter. Finally, our Other category grew 15.4% or down 1.1% versus 2019. Inside this category, we saw ongoing demand for ROSA Knee, as well as increased revenues from the launch of our ROSA Partial Knee and Hip applications. Moving to the P&L. For the quarter, we reported GAAP diluted earnings per share of $0.69 lower than our GAAP diluted earnings per share of a $1.16 in the third quarter of 2020. This decrease was driven primarily by cost of goods and higher spending related to litigation, our spin-off and R&D. In addition, our share count was up versus the prior year. On an adjusted basis, diluted earnings per share of a $1.81 was flat compared to the prior year, even though sales were down. We implemented targeted reductions in SG&A, which in tandem with a slightly lower tax rate helped offset higher investments in R&D and a higher share count. Adjusted gross margin of 70.3 was just below the prior year and the results were slightly below our expectations due to lower volumes in tandem with less favorable product and geographic mix. Our adjusted operating expenses of $852 million were in line with the prior year and stepped down sequentially versus the second quarter. In spite of that, we continue to ramp up investment in R&D and commercial infrastructure across priority growth areas like [Indiscernible], Robotics, and Data and Informatics. And we are offsetting those increases with improvements in efficiency across other areas of SG&A. Our adjusted operating margin for the quarter was 26.1%, largely in line with the prior year and prior quarter. The adjusted tax rate of 15.8% in the quarter was in line with our expectations. Turning to cash and liquidity, we had operating cash flows of $433 million, and free cash flow totaled $307 million with an ending cash and cash equivalents balance of just over $900 million. We continue to make good progress on deleveraging the balance sheet and pay down another $300 million of debt totaling $500 million of debt paydown for 2021 to date. Moving to our financial guidance. We've updated our full-year 2021 outlook based on 2 factors
Bryan Hanson:
All right. Great. Thanks Suky. And to close out our prepared remarks, I'm going to talk about what ZB can control -- our strategy and our execution -- and that's why I have such confidence in our long-term growth projections. The ZB team remains intensely focused on creating value and, most Importantly, delivering on our mission. Our underlying business is strong and overall, we're pleased with our performance in Large Joints and S.E.T. versus market. This is a significant shift for ZB versus where we were just a few years ago and an important driver of our ongoing growth. Our innovation is in full stride, and that's a big part of this. We're going to enter 2022 with a new product pipeline of more than 20 anticipated product launches across the next two years. And of course, this is incremental to a number of new products we recently launched, including, but certainly not limited to ROSA Partial Knee, ROSA Hip, and Persona IQ, which is the first smart knee implant in the world. We're very excited about this launch. And we continue to see strong ROSA placements, increased robotic penetration into our accounts. I think most importantly, just more robotic procedures as a percentage of our overall procedure base. And ROSA is even more attractive because it's a key component of our ZBEdge suite of truly integrated solutions. And that -- it really does help to tie pre, intra, and post-op data together with the goal of changing patient care. And finally, we are accelerating our corporate transformation. We're making great progress on the planned spin-off of our spine and dental business. We just recently appointed a new CFO and other key leadership team members for [Indiscernible]. And we continue to be strategic and selective in our active portfolio management process, and [Indiscernible] key assets over the past year that have helped us to better compete, and more importantly to win across robotics and data, dental, S.E.T., [Indiscernible], and the broader ASC market. We're reinvesting in our business for sure, but we're also advancing efficiency programs designed to streamline and improve how we operate, and very importantly, drive savings. All of this forward momentum plus ZB 's differentiated portfolio, the expected value creation of our plans [Indiscernible] transaction, and our ability to execute really does give us continued confidence in our path to grow revenue in the mid-single digits and to deliver a 30% operating margin by the end of 2023. And I can tell you, this is clearly a time of significant challenge in market pressures. Particularly given the fact that we have such a dependence on elective procedures; there's no doubt about that, but this is also a time of significant opportunity for Zimmer Biomet. And we look forward to delivering for our team members, delivering for our shareholders and most importantly, the customers and patients that we serve. And with that I'm going to turn it back over to Keri to begin the Q&A session. Keri.
Keri Mattox:
Thanks, Bryan. Before we start the Q&A session, just a reminder to please limit yourself to a single question and one follow-up so that we can get through as many questions as possible during the call. With that, Operator, may we have the first question, please?
Operator:
Thank you. Ladies and gentlemen, at this time, we will now begin the question and answer session. One moment please for the first question. Our first question comes from Ryan Zimmerman with BTIG.
Ryan Zimmerman:
Great. Thank you for taking the questions. Suky, I really appreciate the guidance for the fourth quarter. [Indiscernible] maybe $200 million or so ahead of where you're landing for the fourth quarter and the top-line $0.40 or so below consensus in terms of EPS line. And so, just I'd love to understand specifically where you see the greatest Delta, between your previous expectations from a product segment and recovery standpoint. It sounds like VBP is maybe 3/4 of that $200 million. But outside of that, where you see an impact that we should be thinking about from a guidance perspective.
Suky Upadhyay :
Yeah, so thanks for the question, Ryan. Absolutely, our Q4 implied is lower than where we were when we last provided guidance in August and updated in September. And if you remember that guidance is predicated on COVID not worsening and actually starting to see things recover and improve. And as we came into the third quarter, the early part of third quarter, we actually saw some positive momentum with some modest growth in the first two months. But then as we came into September, we saw -- while we saw elective procedures increase in September, as they generally do seasonally, that pressure from COVID and from staffing shortages was greater than expected, such that the growth wasn't there; and we just didn't get to 2019 levels. So you really have to think about recalibrating the third quarter as then you move into the rest of the year because those much lower than we thought. And then our original guidance suggested that Q4 would be at about market growth or slightly better. That clearly is not what we saw in September and so what we're doing is we're taking that September trend, which was down, and we're carrying that forward into the fourth quarter. So that, I would say, is the largest component of our takedown for our rest of year guidance and for Q4 specifically. In addition to that, there's been some incremental additional pressure due to VBP -- we had always assumed that there would be some inventory dynamics that we accounted for within our forward-looking guidance range. But what we're seeing now is slightly bigger impact primarily driven by this notion of we're seeing in-market, and from our local teams are telling us that patients are beginning to defer their procedures until the implementation so they can secure a lower out-of-pocket. So I would really pull back and say that the biggest component is due to that headwind due to COVID. And instead of the fourth quarter growing, as we originally thought, that pressure that we're seeing in September we're assuming that continues for the rest of the year and that really is your biggest deviation.
Ryan Zimmerman:
Okay. I appreciate that color and then just from a margin perspective, stick with you Suky. Longer-term margins -- you obviously talked about 30% adjusted operating margins. The street's assuming about 26.7% in '22, just given the dynamics today and the expectations, how does that sit with you today from that perspective, where consensus is at right now. What is your view of a normalized operating margin and call it a steady-state, normalized operating environment, because you do have some operating expenses and fluctuation as a result of some of these dynamics.
Suky Upadhyay :
Yes. Great, great question. So I'll try and unpack that. First of all, we see next year as a bridge year to that 30% operating margin. But I -- you really have to step back and there are a lot of moving parts into 2022. And I'll just try and break that down one-by-one and help give you some additional color. First of all, like I said about 3Q going into 4Q, as you think about '21 on to '22 you got to recalibrate the starting point, right? We're going to be on a lower revenue base because the pressure that we're projecting to see in the fourth quarter. And then from that, we would expect this COVID pressure to continue at least until the early part of '22, right? So revenue will be pressured. We believe in at least the early part of '22; that's one overarching assumption. And then margin largely follows revenue, especially for our Company from a leverage standpoint and the ability to get profit off of our fixed cost base. But from there, as we move into operating margin, there's a number of moving parts. I would say first inside of operating margin, you have gross margin. The way I've always talked about gross margin sort of in the mid-term is the take the second half of 2020 and kind of think about gross margins being stable from there. It could be slightly up or down in any given quarter, but largely stable to the back half of 20. We still think that that's the right starting point, but what we have to watch out for now is the impact of BVP, and what that does as a headwind. And also, what we're seeing like many of our peers in our sector is some inflationary pressure on cost of goods and input, costs and labor costs. So we're just got to watch those headwinds. Look, our teams are working really hard to help offset those. But that's still a moving target for us and something that we got to continue to put a little bit more rigor on, and obviously we will give more detail when we give guidance at the end of the 4th quarter. Then within operating margin as well, the 2nd key component is SG&A. I'm really proud of what the team has done already this year to respond to lower revenues and lower margins, because all the factors I talked about. And quite frankly, we're accelerating our transformation journey and we're doing that in a number of ways. 1. We're looking at regional profitability and we're looking at restructuring a number of markets that are just below where our expectations would be. We're looking at other areas of our cost base and accelerating our Global Business Services strategy. And there are other structural type initiatives that we're taking inside of SG&A to help some of those revenue and gross margin headwinds that I talked about. So those are some of the moving parts. I'm not going to get into exactly what '22 looks like yet. I think we got to let a lot more play out in the rest of this year, especially around COVID before we can give you a more detailed view of '22. But hopefully, you've gotten some good color there to help you start on '22.
Ryan Zimmerman:
Thank you.
Operator:
Thanks, Ryan. Our next question comes from Drew Ranieri with Morgan Stanley.
Drew Ranieri:
Hi, Bryan and Suky. Thanks for taking the question. I guess just to go off of the previous question, but more so on your long-range plan. Suky, you're mentioning that you're pulling forward some initiatives, but just how are you thinking about your long-range growth right now at margin targets. Maybe help us better understand if any of the composition has really changed in reaching that 30% operating margin. It's about a 400 basis points of expansion, it looks like. But any more that you can provide there?
Suky Upadhyay :
So maybe what I'll do is I'll start off with the components that we've defined as what we need to see for growth rates. And then you can take it from there on the up margin piece. First of all, when we think about this 4% to 5% growth that we're trying to accomplish, we've been pretty clear on what we need to see to make that happen. First and foremost, we need to see above-market growth in our biggest franchise, which is Knee. And we've been able to prove that over the past six quarters or so that we were able to get a trend in that direction.
Bryan Hanson :
Second, is we need to be at market growth in Hip trending to above-market growth as we get ROSA traction, which is now in the market. New to the market, but now in the market. And then we needed to be in that mid-single digit growth rate for [Indiscernible], if not to the upper end of that. And so, those are the areas that we're really focusing on we believe are the building blocks as we get into 2023 to get that 4% to 5% revenue growth. We still believe that that is absolutely possible for this organization since that's kind of the topline view, which should be a big component obviously, of driving that operating margin that we're projecting in 2023 as well. So Suky, I'll pass it to you for that.
Suky Upadhyay :
Yeah, I think that's one of the key components, and we're consistent on how we think about that operating margin expansion. That's largely leverage-driven, right? We talked about gross margins being stable. I've talked about some headwinds are we're going to look to offset over time and then SG&A becoming a lot more efficient, and the ability to reinvest that back against that higher growth, which gives us that leverage to 30% operating margin. In addition, through active portfolio management, we now also have the spin, which is going to create a tailwind for us from an operating margin standpoint as well, so feel good about that. We still think we have all the right building blocks in place to get to that 30% operating margin run rate as we exit 2023.
Bryan Hanson :
All of this obviously assumes that when we're in 2023, that COVID is in the rearview mirror and no longer a headwind, obviously.
Drew Ranieri:
Great. Thank you. And just as a follow-up, just on Persona IQ. Bryan, you just launched the product, but would love to get your initial feedback on what you're hearing in the field and maybe if you could set expectations of how a launch should progress over the next 12 months. I mean, would you be disappointed if it wasn't like 5% of your total Knee implants, but just any flavor would be helpful. Thank you.
Bryan Hanson :
So I'm kind of -- I'm looking at my COO right now across the table and I just gave him a new target of 5% to get IQ and [Indiscernible] implants. He is a little worried about that. But what I would tell you though, all tongue and cheek aside, we're very excited about IQ; this is the first of its kind. It's good to bring technology to the market that literally is new-to-market. And that's exactly what we have. And although we're excited about IQ by itself, it's a really important variable in a much broader equation which we call ZBEdge. Because now what we're focused on in ZBEdge is to be able to collect data before, during and after the procedure and is a really important reason for that, because as that data lake increases, what we're going to be able to do is to predict what kind of care we should provide for the patient. Here's what I know, every time I'm out talking to a surgeon, I don't care how good they are, or what their capability is. They always have a patient, patients that look perfect. They did all the right cuts. They have -- the image looks fantastic. The tissue balancing was perfect, but that patient is not happy. And they don't know why. I don't know why. But as we collect this data and again, the data later gets larger, we're going to be able to predict why and be able to change that outcome. That's the intent here. And why that's really important -- is because when we can do that, you got patients sitting on the sideline right now that would enter the funnel, but are afraid to because they don't believe they're going to get the satisfaction they're looking for. If we can change that paradigm, we can get more patients into the funnel. That's good for everybody in this base. So IQ is very attractive to us, but it's a part of a bigger equation. And I could tell you from IQ perspective, we're in a very limited launch. We want to learn as much as we can as fast as we can. We do have some supply constraints here. And that will put a little bit of a damper on how we're going to roll this out. Microchips are tough to come by. It's not impacting us in ROSA because you're talking in hundreds. When you move to IQ, you're talking thousands. And so it is going to get in the way, in the short-term that we're again -- we're trying to work through it, but that is going to put a damper on our launch. The demand is great, there's a lot of noise around this and people are very interested, so that's a good sign. We've got to work through the supply constraints and move this forward, but overall, we're very happy.
Drew Ranieri:
Thanks for taking the questions..
Keri Mattox:
Thanks and Loren, can we move to the next question in queue, please?
Operator:
Our next question comes from Amit Hazan with Goldman Sachs.
Amit Hazan:
Thanks and good morning. I just want to maybe first to get a clarification on the China situation. I'd love a little bit more color on what you're thinking now in terms of your share within the China market going forward, but also whether you're contemplating spine and trauma in the new impact. And then perhaps most importantly, why would next year be a 100-basis-point impact given that you're already seeing pretty significant impact this year.
Bryan Hanson :
I'll start with the impact. No matter what happens in this base year, we're still predicting a 1% shift to whatever revenue assumptions you've had in 2022. So if you look at growth rate from '21 to '22, that's going to change because you can have more in your base. But the actual impact to consolidate revenues is still 1% in '22. So that's why we're looking at it. And let's say 1% sounds like I know exactly, Just know there's still some variability here. Could be a little more, could be a little less, but I think the right way to model it is 1%. Remembering again that even though it's 1% of consolidated revenue, it's all in large joints. Okay. If I think about our share position in China, we look great -- I just give you a factoid. Just as an example, if you look at our Asia-Pacific 's, not specifically China, but gives you some context here. If you look at our Asia-Pacific Knee business -- the revenue that we do on an annual basis, i's bigger than all 3 of our major competitors' OUS Knee business. That gives you some sense for our market share inside of Asia-Pacific and inside of China. So this is a pretty important market for us. Here's what's great though when we think about share position going forward; even though it's not as an attractive market now because of the margin profile of the business in large joints, we won every one of the categories. There are eight categories. Number 1, it may be an unattractive space but you still got to win. And the first step in winning is you got to be in play. And we're in play in every one of the categories. We're the only multinational Company to do that. Number 2 now is going to be negotiating with distributors. So we get the best distributors to be able to get the most share at the best margin. And that's exactly what we're focused on right now. So that gives you a sense for how we're feeling about it. And when I think about trauma spine, it's too early. What I'd say on trauma, there's a provincial tender that just went through; its 12 provinces tender that we think [Indiscernible] at least hearing rumors could end up being a national tender, kind of transition to a national tender, but we don't have any sense for when that would occur. But anyway, that's our sense for China, our share position and [Indiscernible].
Amit Hazan:
And then I want to focus on [Indiscernible] share with my second question. Just [Indiscernible] -- obviously important for investors. And I think that one of the things that investors have a harder time understanding now is just the fluctuations in share quarter-to-quarter, especially in the U.S. market. And so the question is really whether anything is changing in the way you sell the product. Is there more end-of-quarter selling? What is it that you're seeing or doing differently now that makes it more difficult for all of us to assess whether you're gaining share on a -- kind of consistent basis? I know, like you said, there's been more quarters of share gains than not in the last 6. But still investors are, I think, uncertain as to where that's going because of some of that fluctuations. So what can you do to help us understand what's happening on a quarterly basis that's changed in this COVID era?
Bryan Hanson :
Well, what I would say is there's nothing that I would point out for us. I mean, we're conducting business the way we always have. My sense is probably everybody else's too. I think what's happening is just there's a lot of variability in the market because of COVID. You think about it, I mean, COVID is surging at different times in different states in the U.S. different cities in the U.S.. It all kind of depends on your mix in those states. And that's just looking at the U.S. is even broader than that and more volatile outside the U.S. So I think the challenge in seeing these individual quarters have these odd deltas between competitors is not necessarily because competitors are doing anything different. It's because the market dynamics are very different. That's why I continuously look at trends even in these turbulent times, the trend typically tell us a story because it neutralizing some of that variation. But I don't think it's anything that anybody is doing differently. I just think that the market is creating a much more challenging environment to look at consistency from Company to Company.
Amit Hazan:
Thank you.
Keri Mattox:
Thanks, Amit. Lauren, (ph) can we go to the next question in the queue?
Operator:
Our next question comes from Joanne Wuensch with Citi.
Joanne Wuensch:
Good morning and thank you for taking the questions. Just 2 in particular. The first one has to do with the month of October -- it sounds like you're taking September and applying that, but we have a whole other month of data in between -- is there anything you can share with us on how that is looking or how it looked?
Bryan Hanson :
So what I'm -- without giving specifics, we haven't seen anything in October that we'd indicate that this logic that we're using is incorrect.
Joanne Wuensch:
Okay. And then the other category which [Indiscernible] ROSA, could you share a little bit of color on how that launch is going in terms of utilization, halo effect to other products, competitive accounts, anything that flushes that out a bit would be appreciated. Thank you.
Bryan Hanson :
Yeah. You know, essentially because in these turbulent and challenging times, you always look for things that you're excited about. And our innovation pipeline is one that I'm very excited about, and at the center of that is ROSA. There's no question that we continue to deliver on our expectations there, if not above. And I will just go back to the design characteristics that we put into place. We've really took our time to make sure that we learned from who went first and we designed a robotic system that surgeons really wanted and that's translating into demand and that continues. The fact is, surgeons don't want to change the flow of their procedure. And we have created a robotic system that keeps it as close as possible to non-robotic procedure. We make [Indiscernible] time neutral to be able to use robotics at the same amount of time it would take to do a non-robotic procedure, including all the accuracy though involved in it. And we made sure that we didn't change the standard of care relative imaging. We don't have to CT scan, people don't use it otherwise and they can use the typical imaging that they would use for a procedure. All those things combined with the best implant that we have in Persona is what's driving traction right now. And we are absolutely seeing strong demand, which is continuing for us. We're seeing deeper penetration as a result of that into our accounts; in competitive accounts as well. And what's really important about that is with all these placements now in place, remember that pull-through that you're asking about the commitment of volume is being muted by COVID. So in the COVID, the [Indiscernible] has gone, those units that we have in place will actually increase their overall input and not just in the disposable price point that you have with robotic procedures, but also the pull-through of competitive business. So we're very excited about where we are with ROSA. We know that we've got the right design in place, and we're seeing great traction.
Joanne Wuensch:
Thank you.
Bryan Hanson :
Sure.
Keri Mattox:
Thanks, Joanne.
Operator:
Our next question comes from Kyle Rose with Canaccord.
Kyle Rose:
Great. Thank you for taking the questions. Two for me as well. First on -- you talked a little bit about accelerating some of the transformation programs. Just wondering if you can maybe break that down a little bit more granularly. What specifically have you accelerated, and then maybe what costs do you expect to unlock over the course of the next 15 or 12-15 months?
Bryan Hanson :
So thanks for the question. We're still in the planning phase of that and we'll have a lot more detail around that on our fourth quarter call as we come into 2022. But the key areas for us are really around, as I talked about earlier, accelerating our view of market profitability and regional profitability -- how we ultimately go to market, what's our infrastructure in a lot of our smaller markets and just making sure that investments are in fact aligned to growth and opportunity. So I would say that's one. The second area is we looked across our organization. We looked at how we're structured relative to benchmark and where we had outliers, where we had higher costs; we're looking to take actions to make ourselves more efficient, either through just restructuring and de -layering and/or accelerating moving resources to our highly capable Global Business Services that we have in lower-cost countries. So, those are probably the 2 key areas. I think the 3rd structural area we're looking at is continued consolidation of our ERP systems, which is going to give us a better global process orientation, which could yield savings over time. And then of course we're always actively looking at site rationalization to help with gross margin. And I'm really excited about where the team is moving with pricing improvements going forward. Again, we're going to provide more detail as those become more refined, both on the contribution but also the relative cost to those when we give our fourth quarter earnings.
Kyle Rose:
Great. Thank you and then maybe Bryan on maybe some of the bigger picture longer-term initiatives you talked about. I mean, you talked a lot of ZBEdge in my mobility and we've got Persona IQ and I understand that IQ is going to be a slower roll out, but maybe just help us understand where you are as far as commercialized in some of these initiatives that you talked about the long-term perspective. I'm just trying to really put some goalposts around expectations for investors as far as, when we'll actually start to see the materially impact your business and be a driver or a competitive differentiator.
Bryan Hanson :
Yeah. I think you're already seeing some of this and the nice thing is we're just in the forefront of that innovation pipeline. Here's what's interesting. I think one of the most important things about that 5 quarters out of the last 6 where we've been above market in Knee, isn't necessarily the amount that we've been above-market or just even those 6 quarters. It's looking at the trend break that you're seeing from ZB -- and what do I mean by that -- if you go beyond those 6 quarters and you look at the 20+ quarters that ZB has been a Company, we did not have one quarter as a Company above-market in Knees -- not 1 quarter in more than 20 quarters. So that as a significant reflection of the transformation taking hold. And it's a reflection of the transformation taking hold when we're at the -- just the beginning of the innovation cycle. We're only about a mid-single-digit vitality index right now. Our strap plan would indicate that's going to triple over the strap plan period. That's a dramatic tailwind that we expect to see in our innovation pipeline which is a big part of why we believe this is sustainable. If you look at specifically in Knees and the execution is definitely better than we've seen before. Our compensation structure is now focused on growth rather than just maintaining business and our operating mechanisms are as good as I've ever seen. There's clearly no more supply issues anymore. It's all around innovation now. And innovation still drives from Persona Revision that is still getting conversions on the revision side. But most importantly now, it gives you a beachhead with customers that are using our Revision System in somebody else's total Knee -- guaranteed we're going to be pursuing that total Knee business, and that's bigger than the revision business. You still have ROSA Knee that's just getting started. We've got a lot of headroom in ROSA Knee and that continues to pace very well. ROSA Partial just launched. Remember, at Partial, we have a very large share position. So even if we didn't get competitive business which we certainly are going to try, we have a mixed benefit associated with that in those partial procedures. Persona IQ just starting as we talked about before, and ZBEdge is exciting and then in 2022, we've got a new form factor for our Persona Cementless, which is going to remove all stops for us to be able to pursue a conversion to Cementless Knee. So all those things just give you a lot of shots on goal to continue to drive strong performance in Knee.
Kyle Rose:
Great. Thank you.
Bryan Hanson :
Sure.
Keri Mattox:
Thanks Kyle. Loren can we go to the next question in queue, please?
Operator:
Our next question comes from Sam Broido Kodatsky with Truist.
Sam Broido Kodatsky:
Hi, thanks for taking the questions and I'll just ask both of mine. So when we think about that September pressure continuing into the fourth quarter with the two components being COVID staff shortages. I think the general thinking is that COVID is getting a bit better here. So should we take that to mean staff shortages are becoming a bigger portion of the problem into the fourth quarter. And then as a follow-up to that, a little bit harder to predict when those staff pressures ease up. So how long do you think about those impacting volumes and what are you looking forward to indicate that the pressure from staff shortages is easy. Thank you.
Bryan Hanson :
So I guess either one of you and I can answer this. But what I will tell you is that it's probably a bit of a conservative approach to look at September and then assume that that's going to continue through. A lot of indicators would say it's going to get better. The combination of COVID pressure and staffing. But, here's what we've learned. Every time I try to use an external view of when COVID is going to get better, we seem to be wrong. And so I'm not going to go with that. I'm going to go with what we're actually seeing in the marketplace and what we're seeing in the marketplace is consistency. Not always the same mix of pressures between COVID and staffing, but consistency in the overall pressure in October that we saw in September. And so I've learned my lesson. I'm not going to try to predict this anymore until I actually see proof in the marketplace that we're seeing firsthand that we're bending that curve. We would expect this to continue into 2020. Your guess is as good as -- others have tried to predict when this is going to stop; your guess is as good as ours. We truly do believe this will float into 2020. We don't know how far but we do believe it's going to float into 2022.
Suky Upadhyay :
And Sam, this is Suky. Just to build on what Bryan said, I think the labor shortage is the toughest component to really try and read because it's unprecedented. And it's not just at the nurse level. It's really throughout the hospital setting. What we do know through survey data -- this is not sophistically relevant, so please don't run too far with it but over half of the physicians that have reported in the third quarter have stated that they've suffered from staff shortages. And when those particular physicians have that challenge, they're doing about 10% fewer procedures than they normally would do. So that's very real. And we're also seeing that that impact is greater in the hospital setting than it is in the ASC setting. And as you know, we've got a more prominent share in the hospital setting, so I think it more disproportionately impacts us. Because of those, we're taking the approach until we see substantial, durable improvement, we're going to continue to take a view that this is lingering with us. But again, hopefully it's a conservative view, as Bryan said. Hopefully it lifts sooner than we all expect and we're better off, but that's how we're thinking about it.
Keri Mattox:
And Sam, did you have another follow-up? I think that was 2 questions in 1, but anything that close out there?
Sam Broido Kodatsky:
Yeah. Sorry. That wasn't my tail. Thank you
Keri Mattox:
Great Lauren, can we have the next question on queue then?
Operator:
Our next question comes from Mike Matson with Needham & Company.
Mike Matson:
Yes, thanks for taking my question. I guess I wanted to start with the M&A. I thought you would have done more by now. Are multiples too high, are you waiting to get through all this COVID uncertainty? Do you need to de -lever the Balance Sheet more? Or is there some other reason that you haven't gotten more active in terms of acquisition?
Bryan Hanson :
Yes. So clearly, we would like to do more too, but I got to be honest with you if you think about the COVID pressure from an EBITDA standpoint. And you look at the debt leverage ratio that's created for us, the fact that we've done as much as we have with the limited firepower we do have, is pretty impressive. I'd actually give the team high complements to be able to select targets, get creative in the way that we pay for those targets, even in an environment with high multiples and bringing technologies that are absolutely fundamental to success inside of S.E.T for instance. Our A&E acquisition helps us in our Thoracic space, which is a big growth area for us that we're focused on. The relying technology that we brought in, filled that significant gaps we had in sports and that gives you the ability then to leverage that full portfolio. And even Omni Suite, which is not overly exciting when you talk about blooms and lights, but it gives us bigger presence in the ASC market. All those things happened in concert with a relationship with Canary for its smart implants -- long-term smart implants beyond just Knee during the time that we just didn't have a lot of firepower. We absolutely expect over the next 5 years to increase that firepower, particularly as COVID gets behind us, and we will then flex more muscle in this area. But, I would say the opposite -- I would say that we did more than I think would have been expected, given the firepower we had.
Mike Matson:
Okay, that's helpful, and then just looking at -- in the recon category, it looks like your Hips were down substantially more than your Knees in the quarter and I thought that Hips were somewhat less elective and maybe would have been less affected by the COVID wave than Knee is. Is that really just a reflection of the new products and ROSA Knee side or is there something else going on there?
Bryan Hanson :
Yes. So that is a switch because what we have seen in the past and I think everybody has seen that the Knee procedures were lagging behind Hip mainly because you've got 2 factors. Number 1, it really hurts when you got a hip procedure issue. And there is some trauma related to it as well. But I think what you're finding is that that initial wave was where backlog was being consumed at a faster pace with Hip. And some of that has caught up is my view on it. And then the Knee procedures now are -- patients have really been waiting. You got patients that have been out there for a year that are finally coming in to get a procedure. And so I truly do believe these patients have waited as long as they could from a pain threshold standpoint. But now we're entering the market where a lot of those that had significant pain with Hip or trauma were already in the funnel. That's the only thing I can predict, it's the only thing I can see why it's happening. We'll see what happens next quarter, but that's what I think is happening right now.
Mike Matson:
Okay. Got it. Thank you.
Bryan Hanson:
Sure.
Keri Mattox:
Thanks, Mike. Lauren can we go to the next question in queue, please.
Operator:
Our next question comes from Robbie Marcus with JPMorgan.
Robbie Marcus:
Great. Thanks for taking the question. Suky, on the 100 basis points impact from China next year, is it fair to assume that since its price pretty much just dropped through the bottom line as well?
Bryan Hanson :
That's the right way to think about it, Robbie.
Robbie Marcus:
Got it. So second question, does that hinder your ability to get to your operating margin target at all in 2023? Since I imagine that probably wasn't included. And then just two quick clarifications. If you could let us know what the M&A and selling day benefit was in the quarter. Appreciate it. Thanks.
Bryan Hanson :
Sure. So on the operating margin point, it certainly does add another headwind to get to that 30%. But when we put that 30% aspiration out, there were two big components that we had not contemplated. One was the BPS you just mentioned, but the other was the active portfolio management and the spin of the spine and dental business, which will be margin accretive. We think that those two largely offset one another. So again, that's another reason why we're even in the backdrop of this headwind still confident in our ability to deliver that exit run rate at the end of 2023. Relative to day rate, there is no meaningful headwind, tailwind relative to the day rate. And that's going to be true for the full year as well. And then on the M&A contribution, I would put it in the low single-digits. So if you think about M&A, if you looked at S.E.T. by itself, which is about 20% of our overall revenue, it's in the neighborhood of about 300 bps of benefit. So probably less than a percent for the overall consolidated results. But in S.E.T., it helps by about 300 basis points.
Robbie Marcus:
Great, thanks a lot.
Bryan Hanson :
Sure.
Keri Mattox:
Thanks, Robbie. Lauren, we have time for a few more questions. Can we go to the next one in the queue?
Operator:
Our next question comes from Matt Taylor with UBS.
Matt Taylor:
Thanks for taking my question, guys. Bryan, I just wanted to ask you about what you're seeing in the marketplace and predicting COVID -- I know it's very challenging -- what about the last year would help, I guess inform you what we could see for 2022, in terms of how things could start to come back. We have had [Indiscernible] been closed and after the [Indiscernible] in the early part of the year, we saw a strong 2Q in the fields more muted this time in terms of the comeback. Do you think the delta is [Indiscernible] or is there something else going on in terms of what we've seen so far?
Bryan Hanson :
It's just so hard to predict, every time I think I've got it nailed because I'm looking at trends from the past. I'm wrong, But what I would tell you is I do believe it has been so far and we more recently putting a combination of those two. The Delta surges are absolutely real, and that is impacting capacity in the hospitals less so on the ASC, but definitely the hospital. And staffing surges are very real again, as Suky referenced more in the hospital than the ASC. But both of those things are contributing what we typically look at though, and we still. We still look at starts when is the patient enter the funnel? And usually takes from the time they do to the time to get a procedure 4 to 5 weeks. That seems to be extending now because you've got more people that are entering the funnel, I believe. But here's the thing, we're just not seeing those stats change north versus more than what seasonality would allow. So seasonality is occurring, procedures are increasing. August to September was better, procedurally speaking. We expect the fourth quarter to be better than the third quarter, but that's being muted by these pressures associated with COVID and staffing. And so that's the reason why we're changing the guidance. It's not that procedures aren't increasing, they are. They're just not increasing nearly at the clip we would expect because of these pressures. I wish I could [Indiscernible]. I don't have a better answer, unfortunately.
Matt Taylor:
Sure. There's a lot of [Indiscernible] certainly, but I guess I wanted your view on how much of the staffing is related to COVID. In other words, conceptually, if in 2022 COVID really wanes, do you think there's going to be ongoing staffing issues in the second half of the year or post normalization?
Bryan Hanson :
It's challenging to say because there are multiple components associated with it. Some -- what people are saying is that, is this mandate for vaccinations that is driving some of this change? So if that were to be changed, if say vaccination requirements change because COVID starts to leave the pressure point, maybe. But I don't know, I think that although they may have started because of the COVID challenges, just because of COVID vaccination pressures, whatever it may be -- I don't know that they're going to work in sync. That's just my guess because I have no idea. But my guess is they're somewhat disconnected now, and you may see lingering staffing beyond COVID.
Matt Taylor:
Thanks Bryan.
Bryan Hanson :
Sure.
Keri Mattox:
Thanks Matt. Lauren, can we got to the next question in the queue, please?
Operator:
Our next question comes from Imron Zafar with Deutsche Bank.
Imron Zafar:
Hi, good morning. Thanks for taking my question. I was wondering if you could comment on how you're thinking about blended implant ASPS in the U.S. over the next couple of years in large joints. Obviously, a lot of moving parts with new products, higher mix of Robotics, maybe ASPS versus inpatient, case mix, things like that. Just [Indiscernible] -- how you're thinking about implant ASPS over the next couple of years. Thanks.
Bryan Hanson :
So I'd answer that in 2 ways. First and foremost, we're going to focus on is pricing discipline in the organization. And so if I just take everything else out of the equation, we look to be able to mute some of the pricing impact that we've been experiencing as an organization for a long time. So that up by itself could obviously help from an ASP standpoint just by doing better job on the pricing front, that's one area. Separate from that, a big focus for us is mix benefit. The fact is when we think about share of wallet in a procedure, a lot of the technologies we're launching actually do have an effect of taking up the amount of money you make per procedure. And so if I think about Robotics, you've got a premium. Every time somebody uses a Robotic procedure in that procedure. We think about Cementless, you get a premium every time somebody uses it. We think about Mymobility. Every time somebody uses it, you get a premium in that procedure. So we would actually expect as we get deeper penetration in these key areas of technology -- Persona IQ is another one. As we get deeper technology penetration, we would expect the ASP that we capture inside of an existing procedure to go up and actually be a tailwind for market growth.
Imron Zafar:
Okay, great, thanks. And then secondly, can you just talk about your latest views on the opportunity internationally for ROSA, what your latest thoughts are and timing in key international markets? Thanks.
Bryan Hanson :
Yeah. I'd say we've been very happy actually, with our ability to get traction with robotics very early on outside the U.S. A lot of times, we see a nice split between our U.S. business and our OUS business. I truly do believe in certain markets, specifically Asia-Pacific. We have an opportunity to surpass anybody in the robotics space. If we continue with the trends that we're seeing, we could be the number one share player in robotics pretty quickly in Asia-Pacific, and not in the too far distance in EMEA. It could take a little longer in the U.S., but those are the way we look at it. We don't want to just get presence in the U.S., we want to make sure that we're getting traction in OUS as well. And so far, we've seen that.
Imron Zafar:
Thank you very much.
Bryan Hanson :
Sure.
Keri Mattox:
Thanks Imron. [Indiscernible], I think we have time for maybe one last question.
Operator:
Our final question comes from Anthony Petrone with Jefferies.
Keri Mattox:
Anthony, do we have you on the line?
Anthony Petrone:
Great. Thanks for taking my question. Maybe just to double back on staffing. It seems like there's a number of headwinds as it relates to staffing, whether it be just staff burnout, turnover, just in terms of personnel from healthcare services to industry. And we also heard early retirements could be a big trend in 4Q. So when you think about sort of the stack of headwinds out there, how deep into 2022 do you think some of these trends could last and what do you think that could mean in terms of throughput for ortho recon specifically? And then the quick follow-up would be just on as we navigate the next few quarters, just a recap on pricing for both hips and knees. Thanks again.
Bryan Hanson :
Yes. So again, I think it's really challenging to try to project when staffing concerns are going to end. I think what's interesting about it is just the fact that there are staffing concerns is driving a whole new sub-market for nurses and other folks because you can leave the hospital you're in and you can become a traveling nurse and you can get paid a lot more than you're getting paid inside of the hospital you're at. And so if you're willing to take that flexibility, you're willing to travel, you can get paid a lot more. So it's creating a whole new sub market for nurses, which is exacerbating the problem. I just can't predict it. I'd love to be able to for you, but I'm definitely assuming it's going to happen -- continue to happen in 2022. I just -- I can't say with any accuracy when it would stop. And could you just repeat the second question you had?
Anthony Petrone:
Apologies just as we sort of navigate this period here with some of the Delta headwinds in staffing and in particular staffing with some inflationary pressure in hospitals, just how you think that will translate to pricing, as we head into next year.
Bryan Hanson :
I got you. That's a good question because if you think about it, as people are having to pay for traveling nurses, they're paying a lot more, too, and they're trying to retain their talent in this market, which also cost s more. But this is nothing new. I mean, hospitals get pressured all the time in their margin. And they pressure us all the time from a pricing standpoint. So no matter what the pressure they're feeling, there's going to be really no change associated with how much pressure they put on us for pricing. And so I don't predict any real change in our pricing dynamics as a result of this. As we've said before, I actually would predict over the five-year strap plan to reduce the pricing impact for a number of reasons. Number 1, just better pricing discipline as an organization and number 2, better contracting skills as we contract, particularly with ROSA in place, in multi-category contracting, we can stabilize our pricing. There's clearly going to be headwinds and there's clearly going to be people looking for better pricing. There' s no question about that. I don't believe this particular variable will change the dynamic there though.
Operator:
That does conclude today's question-and-answer session. I would like to turn the conference back to Keri Mattox for any additional or closing remarks.
Keri Mattox:
Thanks, Lauren, and thanks everyone for your questions today. Of course, we'll be speaking to many of you today, tomorrow and throughout the next couple of weeks. If you have questions and need more information, please don't hesitate to reach out to the IR team anytime. Thanks so much for joining.
Operator:
Thank you again for participating in today's conference call. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet Second Quarter 2021 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today, August 3, 2021. Following today's presentation, there will be question and answer session. At this time, all participants are in a listen-only mode. [Operator Instructions] I would now like to turn the conference over to Keri Mattox, Senior Vice President, Investor Relations and Chief Communications Officer. Please go ahead.
Keri Mattox:
Thank you, operator, and good morning, everyone. I hope you are all well and safe. Welcome to Zimmer Biomet's second quarter 2021 earnings conference call. Joining me today are Bryan Hanson, our Chairman, President and CEO; and EVP and CFO, Suky Upadhyay. Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by the forward-looking statements due to a variety of risks and uncertainties. Please note, we assume no obligation to update these forward-looking statements even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties in addition to the inherent limitations of such forward-looking statements. Additionally, the discussions on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within our Q2 earnings release which can be found on our website, zimmerbiomet.com. With that, I'll now turn the call over to Bryan. Bryan?
Bryan Hanson:
All right. Great. Thanks, Carrie, and thanks to everyone for joining us for our call this morning. As we're all aware, obviously, given the news recently, COVID is still very much with us, and we're watching it very closely, as you can imagine. But given that, even we've seen some real progress since our last call, and I think that's obvious to everybody. The world has not returned to normalcy yet, but travel is returning. We have more team members in our offices, and I am personally looking forward to attending the AAOS meeting in about a month in San Diego. So really looking forward to that meeting. We have a lot of great technology that we're going to be able to showcase there and just really happy it's going to be a person again, finally. I want to thank, in that same vein, thank our team again for their dedication to safety, and really just across the board, their commitment to making all of our ZB manufacturing facilities and offices as safe as we possibly can. You, our team members are the driving force for this progress that we've seen in our own facilities and certainly in our communities as well. Also, I want to say that I hope in our investor community that you're continuing to stay safe and have been hopefully able to travel over the last few months to see family and friends. This is an opportunity for us to take advantage of some travel as we begin to turn to more of a normal environment, of course, not there yet, and we know this isn't happening consistently anyway in all regions. But overall, we are encouraged and we're doing our part to keep this moving forward. And every single day, we are supporting our customers and patients that they serve. We're doing this safely, obviously, but this is a big focus for us as a mission-driven organization to be there for our customers so they can complete the procedures that they have, and we can make sure that the patients receive the care that they deserve. And with that, I think it's a good lead into our Q2 call. Today, I'm just going to spend here in the beginning, just a few minutes on a couple of quick remarks, and then I'm going to turn it over to Suky, who's going to get right into a deeper view of our Q2 results. And I think most importantly, our 2021 guidance view on a go-forward basis. And then I'll come back to close out the call with some updates on our active portfolio management and product and pipeline highlights. I'll wait to do that after he provides the guidance information. So just to set him up a little bit, overall, let me just say that our performance in the quarter improved meaningfully from the first quarter of this year, and that was pretty much across all regions and product categories. And as recovery from the global pandemic continued to take hold, we saw that recovery in our procedure is also moving in the right direction. While we certainly anticipate some ongoing COVID pressure, we currently think it's going to be manageable by hospitals, and we expect that the recovery will continue to build sequentially throughout the second half of 2021. Again, not out of the wood yet, but we do believe, thanks to the hospital's ability to better manage these COVID patients and the vaccine rollout continuing, we believe it will be manageable through the back half of the year, again, moving in the right direction. And with that, I'm going to turn it over to Suky for our financial update, and then I'll be back with you in a few minutes to close out the call before the Q&A.
Suky Upadhyay :
Thanks, and good morning, everyone. For this morning's call, I'm going to discuss our Q2 results, walk through the updates we've made to our full year 2021 financial guidance and provide color around our current expectations for the third and fourth quarter. Moving forward, unless otherwise noted, my statements will be about the second quarter 2021 and how it compares to the same period in 2020. And my revenue and P&L commentary will be on a constant currency or adjusted basis. Also, I'll provide constant currency revenue growth versus 2019 as we think that is a more relevant comparison for this quarter. Net sales in the second quarter were $2.027 billion, a reported increase of 65.3% and an increase of 60.7% on a constant currency basis versus the same period in 2020. When compared to the second quarter of 2019, net sales were flat on a constant currency basis, and we did not have a material impact from selling days. Overall, consolidated and regional results were slightly better than the expectations we provided on our last quarterly call, with growth versus 2019 in the Americas and Asia-Pacific and sequential improvement in EMEA. For the quarter, the Americas increased 68.3% or up 1.9% versus 2019. We continue to see variability by country within the region with the U.S. growing 66.2% or 3.3% versus 2019. EMEA grew 80.5% or down 7.3% versus 2019, with continued COVID pressure being a factor. We did see improvement in EMEA as we moved through the quarter, and we expect that trend to continue through the back half of this year. Lastly, Asia-Pacific grew 24.4% or 2.8% versus 2019 in spite of some unexpected headwinds. While the region has been largely stable in recent quarters, it was impacted late in the second quarter by channel inventory contraction in our knee and hip categories within China. in advance of the rollout of volume-based procurement or VBP. In addition, we saw a resurgence and increase of COVID-19 in a number of markets, including Japan. Despite these headwinds, the region continued to post growth. Turning to our business categories. The global knee business increased 72.2% or down 6.3% versus 2019. In the U.S., knees increased 77% or was flat versus 2019. While we are seeing sequential improvement in the recovery of procedural volumes in large joints, the path back to normalized market growth is taking a bit longer than most expected. Still, we continue to be encouraged by the team's execution and ongoing strong momentum for Persona and ROSA Knee. Our global hip business increased 39.9% or down 2.8% versus 2019. In the U.S., hip grew 46.6% or up 3.1% versus 2019. Strong demand and favorable feedback continues for the Avenir Complete Hip, which continued adoption for both gold and platinum accounts. The sports, extremities and trauma category increased 53% or up 10.8% versus 2019, driven by solid growth in sports medicine, CMFT and upper extremities. We continue to see strong surgeon registrations of the Signature One surgical planning system for shoulder procedures. Our dental and spine category grew 69.4% or up 0.8% versus '19, fueled by recovery in dental. New products and better commercial execution drove growth in the quarter with strong contributions from implants and digital solutions in our dental business. Finally, our other category grew 105.9% or up 7.5% versus '19. This reflects the ongoing demand for ROSA Robotics and strong capital purchases in the quarter. We saw improvements both sequentially versus Q2 2020 in units sold as well as increased revenues from software due to the launch of our partial knee application. Moving on to the P&L. For the quarter, we reported GAAP diluted earnings per share of $0.67. Our reported GAAP diluted earnings per share were up significantly when compared to a reported GAAP diluted loss per share of $1 in the second quarter of 2020. The increase in year-over-year GAAP earnings was driven by higher revenue, offset by normalized spending levels and IPRD investments within the quarter. In addition, the second quarter of 2020 had some onetime GAAP charges that did not repeat. On an adjusted basis, diluted earnings per share of $1.90 was significantly higher than the prior year, driven as expected by the recovery of elective procedures since the pandemic trough in the second quarter of 2020. Adjusted gross margin was 71.7% and in line with expectations. Our adjusted operating expenses of $923 million stepped up sequentially versus the first quarter due to higher variable selling expenses related to higher sales and increased discretionary spending to support investments in commercial infrastructure and innovation through R&D. Improved revenue performance and stable gross margins more than offset higher spending to drive 26.2% operating margins, a slight improvement over the first quarter of this year. The adjusted tax rate of 16.5% in the quarter was in line with our expectations. Turning to cash and liquidity. For the quarter, operating cash flows were $453.9 million, and free cash flow was robust at $358.7 million, and we ended the second quarter with cash and cash equivalents of just over $1 billion. We continue to make good progress on deleveraging the balance sheet and expect to make another $300 million in debt repayments in the third quarter. Moving to our financial guidance. As noted in this morning's press release, we have updated our full year 2021 outlook. We are tightening our guidance range to better reflect our year-to-date performance and a more informed view of the potential impact of COVID. There are some key assumptions that underpin our 2021 financial guidance. We assume no worsening of elective procedure trends due to COVID and that procedure volume recovery continues in the second half of the year, but recovery may not be linear by region and/or by product category. We also expect to see seasonality impact to the third and fourth quarter as we have observed in prior years. With the narrowing of our guidance range, we are now expecting reported revenue growth to be 14.5% to 16.5% versus 2020, with the impact of foreign currency unchanged at about 150 basis points of a tailwind for the full year. On a constant currency basis, compared to 2019, we expect Q3 to grow sequentially over Q2 and for that improvement to continue in the fourth quarter. Turning to the P&L. Our adjusted diluted earnings per share is now in the range of $7.65 to $7.95, and we have narrowed our adjusted operating margin projection to be 26.5% to 27% for the full year. Our updated EPS guidance reflects our performance to date, our expectation of improved growth in the second half and that discretionary operating expenses remained consistent with Q2 through the balance of the year. While operating margins are expected to decline sequentially in the third quarter, in line with lower sales revenue and steady investment levels versus the second quarter, we expect overall second half operating margins to be stronger than first half operating margins. Our adjusted tax rate projection is unchanged at 16% to 16.5% for the full year. And finally, our free cash flow estimates remain in the range of $900 million to $1.1 billion. We will continue to update you on market dynamics and financial expectations as we move through the remainder of the year. To summarize, our performance in Q2 was slightly better than our expectations that we have communicated to you through the second quarter. While we anticipate some ongoing COVID pressure, we have more confidence in the momentum of the recovery and our ability to execute against that backdrop. With that, I'll turn the call back over to Bryan.
Bryan Hanson:
All right. Thanks, Suky. And I'm going to now just hit three topics before we move to Q&A. First, I want to talk about execution in some of the product and pipeline highlights that we have under that category; second, I'm going to talk about our progress against active portfolio management, which is a big effort for us, obviously; and then third is innovation. And inside of that innovation, how we believe we're going to be able to drive attractive long-term growth that ultimately will deliver value to you, our shareholders. So let's start with our team's execution. And I've said this before, and I'll continue to say it, that the things that ZB was able to directly control over the past year, 1.5 years, the team -- they've executed against it, they delivered against it. And I'm very proud of the team for doing that during a time of significant turbulence around them. And in Q2, in the recent weeks, we've hit key milestones with our ZB products and our solutions. ROSA for Partial Knee was approved back in April, as we've talked about before. And our first patient surgery was actually performed early in the quarter, and we've continued to see good traction with that technology so far and great feedback so far. And it's important for us because partial knees, I think most of you know, is a market where ZB has a sizable market share position. So we're very excited about the possibilities here, not just from a revenue standpoint, but also the potential impact for patients in the surgery area. And then if I just look at ROSA overall, we did see another strong quarter in Q2 of market demand and traction with ROSA total knee as well with placement momentum broadly continuing across the world, not just in the U.S. but internationally as well. And that's important. We want to see strength in the U.S., but we want to see that OUS, and we did get to see that kind of mix again in Q2. We also saw capital expenses for our customers being much stronger in Q2 and as a result of that, we saw a shift back to upfront sales of ROSA. So more of those happened in Q2 than what we would typically see. And again, that just speaks to the strength of capital budgets and people's desire to acquire in that way. But what is clear is that there's a real focus for hospitals to be bringing in robotic systems for their ORs whether they buy them outright or they get them through other arrangements. Either way, that momentum, that demand is very real. And ROSA continues to be a cornerstone, one of the key ones, of our ZB Edge suite of connected solutions. And our forward-looking robotics pipeline is going to be robust as a result of that because that's a big part of our strategy. So again, a lot of enthusiasm on what that will mean in coming years in terms of expansion of indications. and overall robotics penetration for ZB. Also in the quarter, we saw a revision continue its very strong momentum. Again, this is a great tip of the spear product for us, where we can go in and get competitive conversions and revision but also use those competitive conversions for access to the typical total knee as well for that surgeon. So very exciting, not just on the revision side but also opening the door to a much larger opportunity to get their typical knee conversion as well. We're also excited about adding another key variable to our ZB Edge portfolio of connected technologies, and that is our Persona iQ, which will be the first and only smart implant on the market. And we certainly still have to get FDA approval on that. We're working diligently with them to help with any information they need to move that forward, and we're certainly hoping to receive approval in the relatively short term. But ultimately, again, that time line is up to the FDA. And it's important for us because it takes the Persona implant, which is that known and trusted design in an implant and it combines it with Canary Medical's tibial extension, which has the sensor technology in it. And the combination of those 2 things will now inside the body, give us an opportunity to measure the range of motion of that patient, step count, walking speed and other mobility metrics that we believe are going to be indicators of post-surgery progress. So again, helping us close the loop in those connected technologies that we have in Zedge -- So more to come when we hear back from the FDA. But once we do get that approval, we would look to limited launch the technology for a quarter or two and then post that time frame, move into full launch. Okay. So let's move to my second topic that is on active portfolio management and our efforts around active portfolio management. We have the ZB portfolio management strategy in place. We have the right process in place, and we have definitely built our capabilities to move this forward over the last 1.5 years to 2 years. So we're excited about this phase of the organization. And we're focused, as we said before, on mission-centric M&A that is WAMGR-accretive. So in other words, weighted average market growth accretive to the organization. And you've seen us move this forward already with the selective tuck-in acquisitions that we did late last year that really illustrate our strategy at work. These are smaller deals, again, tuck-in size deals that were designed to fill portfolio gaps and better position us as an organization in high-growth, high-priority markets like sports medicine, ASC and sternal closure where we truly do believe we have a right to win in attractive markets with strong profitability. And of course, there's the planned spin-off transaction of our spine and dental businesses that is fully underway and on track. We continue to be encouraged by the energy and the momentum around NewCo. As CEO of Vafa Jamali, builds out his team and refines his corporate strategy, and we believe creates two independent and even stronger companies that is going to maximize value for not just our customers, but also for you, our shareholders. All right. And that brings me to the last topic that we have before we move to the Q&A, and that's going to be around innovation. And really inside of innovation, how we see our ability to drive attractive long-term growth that will ultimately deliver value to all of our stakeholders, including you, obviously, our shareholders. We are focused on evolving ZB from what I would define as a metal and plastic provider of implants into a leading med tech innovator. And we have a lot of shots on goal across a number of programs to do this, including a number of robotics launches over the near term, smart implants that we have today, but also the technology road map that we have in smart implants. New functionality with mymobility and really just the broader ZB edge ecosystem of those connected technologies that are going to help us drive mix benefit and share of wallet benefit, but also competitive conversions. And I've mentioned before, more than 70% of our new product development investment is directed towards ZB edge and those connected technologies inside of ZB edge. And our exclusive partnership with Apple continues to be productive and collaborative. And we forged several other tech alliances that we know are going to drive future innovation that will benefit patients. And I believe this fundamental shift is coming for ZB and for our core markets with technology advancements, potentially changing the care paradigm for patients in the future, and that's really what our focus is. So the momentum is real on the innovation front. And we think it will ultimately allow us to drive long-term growth that is very attractive to us and to you. And most importantly, it also gives ZB the chance to really change the lives of patients around the world. All right. Let me close by saying that I continue to be highly confident in the ZB team and our business momentum. While there continues to be uncertainty due to the global pandemic that we cannot control, I truly believe that we are ready and well positioned for success. And our strategy is absolutely working. The transformation of our business is well underway, and I'm excited about the value we can drive for our shareholders on a go-forward basis. Now I also want to make sure that I take the time to thank the entire ZB team. Your dedication to safety is critical and your focus on delivering on our mission is unmatched and you do it daily. I remain incredibly proud of what we're accomplishing and what we're accomplishing together. And with that, I'm going to turn it back to Keri for our Q&A session. Keri?
Keri Mattox:
Thanks, Bryan. [Operator Instructions]. With that, operator, may we have the first question, please?
Operator:
[Operator Instructions] Our first question comes from Josh Jennings with Cowen.
Josh Jennings:
Bryan, I was hoping you could just share how internally your team has been tracking Zimmer Biomet's U.S. hip and knee market share and any breakout of the progress in the De novo revision segments would be helpful. And then as you think about your revenue growth acceleration journey post spin, do you envision the introduction of enabling and sensor technologies driving that positive mix shift and expanding or accelerating U.S. knee and hip WAMGR up into the mid-single digits? Or how do you see the U.S. large joint markets growth evolving in the next coming years?
Bryan Hanson:
Yes. No problem, Josh. Let me start maybe with the second part of your question because I would say beyond sensors, just what we define as ZB edge, which is the interconnected technologies that actually do full data for the patient journey. We really do believe that those technologies, including robotics, sensors in the body, mymobility, OrthoIntel, so on and so forth, will absolutely bend the curve when it comes to growth rate in knees and hips in other areas as well because we would proliferate those beyond just knees and hips. So just I do believe that, that technology, which is being absorbed by the folks in orthopedics right now does provide us an opportunity to enhance our growth rate as an organization for two reasons
Operator:
Our next question comes from Vijay Kumar with Evercore ISI.
Vijay Kumar:
Bryan, both of my questions into one. Back to your prior comments here on share gains versus the market. But I guess, discrete is focused more on near-term sequential trends here. Why would Zimmer perhaps be seeing different trends versus your peers? I think you made some comments about the backlog burn being a little bit slower, et cetera. Maybe put that in perspective for us? And my second question is, your ROSA, I think one of the key advantages of the system is ease of use, the higher throughput. Given there is a backlog, are you seeing increased traction here or customers appreciating this speed advantage of ROSA? And what does that translate to a total installed base or share gains perhaps for Zimmer?
Bryan Hanson:
Yes. So maybe I'll start with the ROSA throughput. And as you probably remember, we spent a lot of time thinking about the design characteristics of ROSA is one of the primary things we want to focus on is to make sure that we did not disrupt the surgical flow and certainly did not want to add time to the surgical procedure. And that has benefited us. There's no question. I mean, to me, it wouldn't matter whether we're in a COVID environment or a non-COVID environment. That is something that our surgeons are pursuing. And they very much appreciate the fact that it's not disrupting their flow, and it's not dramatically increasing any the times to do procedures. So that is a benefit for us for sure. And again, I don't think it really matters whether you're in a COVID environment or not, that's just a benefit. One of the things relative to share gains that you talked about and our view on backlog, I don't know that our outlook and what we've described is really any different than anyone else who plays in large joints like us with such a significant share position. It seems pretty consistent with -- to me anyway. If I think about the deferred patients, I'd just say that like most people at this point, that just becomes more challenging now as time continues to be added to the equation. It's just unprecedented right now that what we're dealing with, just given how long this has gone on. And there are just too many variables in my view, just to really size this appropriately, and I think anyone would probably say this now. But that said, we still believe that there's been no structural shift in the disease state. That's what we've been saying all along. And as a result of that, there's got to be a sizable deferred patient population out there. And when we originally analyzed what we thought would happen with that deferred population, we looked at Q3 of last year. And we assume that when -- based on what we saw in Q3, that when the vaccine was available, you would have a pretty significant return of deferred patients relatively quickly. And again, that's what we saw in parts of Q3 last year when the virus was subsiding. So we just assumed that would happen this year. Now fast forward today, the vaccine is here, and we've got more current data and more data points that are playing out right now. And this doesn't seem to be materializing for anybody. And as such, our current thinking is that deferred patient demand will like become at a more gradual pace and probably be more consistent over a longer-term period of time as a result. I think that's really what we're contemplating by the way. When you think about the midpoint of the revenue range that we just provided, the implied range for the back half of the year, but actually at the top of that range, as I think most people would say, we would need to see a change in the current pacing of that recovery. So in other words, you'd have to see it reflect an increase in deferred patient demand that would also be matched by capacity increases to get to that top end of the range.
Operator:
Our next question comes from Anthony Petrone with Jefferies.
Anthony Petrone:
Hope everyone is doing well. And maybe just a quick follow-up on backlog. Is it safe to assume, Bryan, that it's still sort of at least a $700 million opportunity and that perhaps could certainly extend into 2022, but maybe even beyond a bit. It sounds like perhaps that's where you're headed. And then a few quick follow-ups on Persona iQ does sound to us from our checks that there is pent-up demand for the sensing capability. So a few questions here. Do you need to be standardize on ZB edge to take full advantage of the implantable recorder? And will Persona iQ actually drive additional surgeon reimbursement over time?
Bryan Hanson:
Sure. So maybe I'll start with the backlog just because it's maybe a simpler answer. I just -- I don't want to try to size it because I think it's gone on too long. And as I said before, I just don't know how you look at this unprecedented situation and try to put a size to it. All I would say is that based on our assumption of no structural change in the disease data, it's got to be big. I'll just -- I'll leave it at that, but I don't want to try to size it. And yes, my current thinking is based on the data points that are available to us, is that it's likely going to be a slower role with that deferred patient group coming in. And that would indicate that this should take a while for us to work through it. That could change at any time, but that's the data points that we have right now. Relative to iQ, I'm glad that you're hearing there's pent-up demand because certainly, we're feeling that as well, and we're getting excited about the launch, the pending launch. And we still obviously cannot market the technology because we don't have FDA approval, but we do believe that, that should be coming soon. And yes, we're excited about it, but you do not actually need to have the full ZB edge infrastructure to take advantage of it. What we would like to see people do is to have mymobility and the Persona iQ combined because we believe the combination of the data collection between those 2 is extremely beneficial, but you don't really even need that. But that would be the goal for us to have that move in concert and be able to have the mymobility in concert with the iQ implant. And we do feel that all the components are there for remote patient monitoring. That's the whole idea behind this. Through mymobility, through iQ is to be able to remote patient monitor. And as a result of that input provided, be able to make decisions on what you do or don't want to do with the patient. And so we believe that we have what would be required for a surgeon to get a reimbursement for RPM. That's the way we're looking at it today. At the end of the day, that's not our decision on whether it happens or not, but we do believe we have the components to make that available to surgeons.
Operator:
Our next question comes from Steven Lichtman with Oppenheimer.
Steven Lichtman:
I'll ask my two upfront. Bryan, you talked about the momentum sequentially in ROSA. Obviously, we saw that in the reported numbers. As we think about the implant pull-through opportunities, can you give us a sense of what percent of placements are going to accounts that are competitive accounts or ones where you have low share. And then, Suky, just as a follow-up on gross margin in the first half an ahead of the second half of 2020. Do you see upside to your original expectations for 2021 on gross margin, which I think was to be about in line with the second half of last year?
Bryan Hanson:
Great. So I'll go ahead and start with the ROSA question, and then Suky, I'll pass it off to you. I would just say that, yes, again, we're excited about the traction we're seeing. And as the way I look at this, it's not just the traction that we're seeing with ROSA, I'm excited because there seems to be a significant openness in orthopedics for technology. And that's really important, I think, for two major reasons. One, because I truly do believe the technology is going to change the care paradigm for patients. You're going to get better outcomes as a result of it. And when you have that happening, I believe more patients will enter the funnel because they're going to have higher confidence in the procedure. Remember, there's still 20% of me patients that are not happy with the outcome. And if we can reduce that through technology, I believe you've got patients sitting on the side that would enter the funnel, which is good for everybody, patient included. So I'm very happy to see momentum in ROSA, but I'm even happier to see technology adoption in orthopaedics overall. And when we think about our placements, it's interesting because we focus in two major areas. We spend most of our time in platinum accounts and gold accounts. And both of those would just be very large accounts. The difference between the 2 would be platinum. We have a higher share position. And in gold, we have a lower share position. But those are the two areas that we concentrate mostly with ZB edge and ROSA. Now what's interesting about that though is even when we go into that platinum account, it's very rare that we would have a homogeneous new usage in the account. So even when we get a platinum customer that is using us in knee, to move into ROSA, we typically get competitive conversions to ROSA because you have competitive surgeons in those accounts. And of course, in gold accounts, you get the same thing. So it's almost every placement that we have very rarely otherwise, provides an opportunity for us to get a competitive conversion. And hopefully, that helps with the way we're thinking about ROSA.
Suky Upadhyay :
Yes. Stephen, it's Suky. You're right. When we talked about gross margin for 2021, we talked about it being stable to back half of 2020, right? We said it may not be the same for each quarter because there are a lot of variables that impact gross margin. But we said broadly that it would be in line or stable. And that comes off with many years of declining gross margins. So it's a good first step and in actually seeing that stability. First half fortunately was a little bit better than the back half of last year, and so we're encouraged by that. We expect the second half of this year to be pretty much in line with the second half of last year, so very consistent with how we've previously guided. When you average those two together, the first half of this year being a little stronger in the second half being in line, that would suggest that the full year should be slightly better than what we saw in the back half of last year. So we're encouraged by what we're seeing there. I do want to just thank and recognize the supply chain team as well as the commercial team for a lot of great efforts on our cost down initiatives, looking more strategically at P&L and really looking for opportunities to become more efficient in our cost of goods just overall. So seeing some good progress so far. So we're encouraged, and that's how we thought about it, and that's what's baked into our guidance moving forward.
Operator:
Our next question comes from Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
Suky, I just want to make sure I'm understanding the second half revenue guidance and cadence. When I look back before 2020, the last five or six years, Q3 is typically down about 6%. And Q4 is typically up about 11% sequentially quarter-over-quarter. Based on your comments earlier, I thought I heard you say Q3 would be down maybe 3% but Q4 would be up, call it, 14% to 15% to kind of get to your midpoint of your guidance. So it's better than kind of we've historically seen. Can you comment on July trends? And am I right to think that you expect a little bit better seasonality in the second half of 2021 versus what you've typically seen?
Suky Upadhyay :
Yes, absolutely. So my comments earlier in the call were really versus 2019. And so that's kind of where I'll play for this answer. We do expect to see seasonality on an absolute basis, Q3 generally tends to be lower in absolute sales other than Q4, and we expect that to play through for the second half of this year as well. We do expect half of this year as well. We do expect versus '19, where Q2 was about flat, as we mentioned earlier for the third quarter to step up. And as you suggested, that is a little bit better than what we've seen underpins the continued recovery, which ultimately underpins our guide for the back half of the year. And then again, for that to step up again sequentially in Q4, again, all versus 2019. So that's how we currently see it. And again, it's pretty much based on that continued recovery that we've already seen in Q2. What we've seen early on in Q3, we're not going to talk about individual or specific months as we move through the rest of this year. But so far, what we've seen in July underpins and supports what we've provided earlier today.
Bryan Hanson:
Suky, let me just add some color to that. I just -- when I think about what Suky just referenced that we've got a pretty significant assumption in our guidance range that says COVID pressure doesn't get worse and the recovery builds through the second half. But we didn't just assume that. There are some proof points that we're seeing, and that might speak to your question, Larry, maybe a little more. There's really kind of two things that we're seeing that would give us confidence in that assumption. And the first one is that even with the recent virus surges that are all over the news, I mean, you can't look at the news any time during the day and not see something about the virus surge, but it doesn't seem to be translating into the same significant revenue disruption that we've seen in the past and certainly not helping us, but it's not translating into that same kind of revenue disruption we've seen in the past. So -- and I believe that's likely because we've got more vaccines out there, obviously, which is impacting the way people feel when they get sick. But also, I just think that hospitals seem to be managing this patient population better. And the second kind of proof point for us when we thought about this as an assumption inside the guidance range, is that the vaccine is available. I mean let's face it. It's available globally anywhere. Anybody who wants it can get it. And I truly do believe even though it stalled a bit in certain parts of the world, I do believe as people get more educated on the Delta variant and the risk associated with that. That may be a good motivator for people to come in that have been waiting to actually get the vaccine. And so those are kind of the proof points that we have that give us confidence that we should see the continued recovery in the back half.
Operator:
Our next question comes from Chris Pasquale with Guggenheim.
Chris Pasquale:
Two Questions. Just trying to understand some of the moving pieces in the quarter a little bit better. First, can you quantify at all the impact of the China inventory drawdowns? It did seem like Asia Pacific was the source of the shortfall versus consensus in hips and knees this quarter. So it would be great to just understand magnitudes there a little bit better. And then can you put any numbers around the ROSA contribution this quarter. The other revenue line was a big upside driver. Just be helpful to know how much of that came from increased system volume versus that shift in the preference between placements and upfront purchases for your customers?
Bryan Hanson:
Yes. So maybe Suky, why don't I take a shot at the ROSA piece and then I'll pass it to you on VBP impact. But on the ROSA side, I probably don't want to speak specifically to the dollar amount, but obviously, it was a big enough shift for us to talk about it. So that might help you kind of size it in your mind. But what I would tell you is that the way I think about it, is in a normal quarter, what we would typically see is better than 50% of our placements being done through a long-term contract, which is -- we actually like that because it does link us to the customer, and it usually has a competitive pull-through commitment as a result of that arrangement. And in this quarter, we just saw that flip. The higher than 50% move to upfront purchases which is different than what we've seen in the past. What I don't know for sure is that that's going to continue. I mean clearly, there were budgets that were available to people, they flexed those budgets that could continue. Hey, I'm happy either way we place ROSA. We're going to be very flexible with our customers as we go forward and make sure that we're there to support them. Our preference, as I've said in the past, is those long-term contracts, but I'll take an upfront sale as well. So hopefully, that helps on the ROSA side and then Suky, I'll pass it to you on the VBP impact.
Suky Upadhyay :
Yes, sure. Thanks, Bryan. Yes, as we noted, Asia-Pacific sales were impacted in the quarter really by two things. One is the VBP impact that we talked about, which was essentially some distributors taking some inventory contraction ahead of VBP. And the second was we did see surges late in the second quarter in some of our larger markets like Japan and Australia and New Zealand that also slowed some of our growth down. And that hit pretty much across both of those VBP as well as slowdowns in our recon business. But it was encouraging that despite those headwinds that we were able to manage through that and actually grow the region a little bit ahead of expectation. And we would expect that growth to continue in the back half of this year. Regarding China VBP, for competitive reasons, we're not going to size that. It was a contributor. We're not the only contributor in that performance in Asia-Pacific, as I mentioned. I think the important thing is how do we think about this going forward? We've looked at VBP and done a number of scenarios based on what we know at this time. Again, the final rules, pricing and volumes aren't expected to be issued for let's call it another few months, but that timing has been shifting around, so it could continue to shift. But based on what we know today, we don't expect there to be a material impact from inventory change going forward. And that's what's represented in our guidance moving forward. But again, we're going to learn a lot more about VBP over the coming months, and we'll update you as we learn more. But again, it was great to see that Asia-Pacific did grow through that. And I would say also, fundamentally within China, we're seeing very strong demand. And so obviously, that was the first market to be impacted by COVID-19, and it was the first market to recover, and we continue to see good strength and progression in that market. And as you know, we're a leader within China and expect to maintain that leadership position as we move forward.
Operator:
We'll take our next question from Matt Miksic with Credit Suisse.
Matt Miksic:
I have one on S.E.T and just a follow-up on ROSA, if I could. So on S.E.T, Bryan, or Suky, if you could provide some color on sort of the components within that business that was driving some of the strength, at least upside to our estimates trauma, was it extremities? Was it sports is a little smaller, but was that where you saw some of the strength? And as I mentioned, I have one follow-up on ROSA.
Bryan Hanson:
Yes, that's one of the highlights that I saw in the quarter. Clearly, we are heavily penetrated when we think about our overall revenue in large joints. And as I think everybody has been saying and recognizing large joints have just been a little slower to recover than some of the other categories that we have. And what I've been very happy to see is our strength in said, and we believe that, that's going to continue through the back half of the year, pretty across the board, we showed good performance. Standouts for us were sports, the upper extremities business for sure was solid, trauma was solid for us. And of course, when we look at our CMFT business, our thoracic business was quite strong as well. So we're excited to see that the tuck-in acquisition that we did in CMFT is playing out the way we expected. And then some of the acquisitions that we did that were really just product launches, filling out gaps that we had in sports and also in the ASC, they're also providing benefits right now. And that was the whole idea, right, to fill out that product portfolio. As a result of that, have a fight and have a right to fight and win. And that's playing out right now. So we're feeling good about the strength in S.E.T, probably have more confidence now in that being able to continue on a go-forward basis just given what we have in the portfolio. So very happy to see that strength in S.E.T, and we would expect that to continue.
Matt Miksic:
And just a follow-up on ROSA. So I don't think many of the other folks putting robots into the field are seeing the kind of shift back to capital that you're seeing. It seems like it's been pretty stable. And I'm wondering maybe if you could talk a little bit about the mix of accounts, maybe the mix of ASCs or the larger centers. And if there's any change in the mix that might be driving some of that preference for cash payment versus commitment to long-term contracts?
Bryan Hanson:
Yes, sure. Really, no dramatic shift. I mean even if I think about U.S., OUS, for instance, we typically do, it's not always exactly this way, but if I look at the number of quarters and just kind of aggregate them, we typically do kind of a 70-30 split U.S., OUS, and that was pretty consistent in this quarter. For us, again, we did see that shift. We believe that it's mainly because people have more budget right now on the capital side. I don't see a shift in our customer base that drove it. So nothing that just stands out for me. It's just more that there was capital available. People like to flex the capital when they have it. And some customers just don't want the long-term contractual obligation, bringing a piece of capital in, they'd just rather buy it. And so I think that's really the corporate, there's nothing beyond that, that I've seen. Now we'll certainly pay attention to it as we go forward, but nothing that was disruptive in any way relative to mix that would have changed that change in placements.
Operator:
Our next question comes from Rick Wise with Stifel.
Rick Wise:
Bryan, maybe just to start with M&A, you obviously highlighted that M&A remains a top priority. And I heard you about the WAMGR accretive and you listed some areas. How do we think about the next 6, 12, 18 months? Do you feel like you have a lot of targets. Do you feel like you have a lot of opportunities? Do you feel like you're moving faster? And the points you mentioned about robots and smart implants, et cetera, et cetera. I mean do we envision that it's more about acquiring enabling technologies or incremental technologies that enable you to achieve that? Or no, you're ready for something larger freestanding to accelerate? And then I'll ask a second question.
Bryan Hanson:
Okay. Maybe just quickly here, and I'm going to pass it to Suky because at the end of the day, the M&A strategy is only as good as the funding for it. So obviously, we're both focused on moving this forward. But let me maybe pass it to Suky. He can give you the same color I would on what we're looking for from an M&A standpoint, but also give some color on how we're feeling about our firepower there. So Suky?
Suky Upadhyay :
Yes, absolutely. So we continue to build out, I think, an attractive pipeline of potential tuck-in targets. Very consistent with what Bryan said earlier about things that are mission-centric where we have the right to win, strategically makes sense, financially are strong and have a low level of synergy disruption and very consistent with sort of the deals we did at the back end of 2020, which so far through the integration process, we're very pleased with how those are progressing. So we're going to continue to look at opportunities very similar to those. And the good thing is our firepower continues to build. And with the recovery of the pandemic, we're seeing our EBITDA improved significantly. We've turned the corner on the second quarter of 2020, which was a cliff for us, as you know, a trough, if you will, on EBITDA. And with a rolling 12-month EBITDA number as we sunset the second quarter of 2020, we're seeing a pretty big step up in our EBITDA number and a nice improvement in our overall leverage ratio. When you combine that with the debt paydown we've done so far, the debt paydown we're committing to in the back half of this year, and the over $1 billion on the balance sheet, we feel we're in a stronger position than we have been for the last 15 months to And so I feel really good about where we are and how we're moving forward on that. I would also say, another big component of that is our spin transaction. We're really pleased with how the team has been progressing on that. We've made significant progress with our tax private letter ruling, great progress with our carve-out financials and our 10x, which we hope to file in the not-too-distant future with the SEC on a private basis. Good progress from BofA in formulating this go-forward strategy and building out his team. So just overall, really, really impressed with how the team has handled this in the backdrop of also integrating those transactions we did at the back end of last year. So that muscle, that capability that we've been building over the last couple of years is really playing out to our benefit right now.
Rick Wise:
Got you. Go ahead, Bryan. Go ahead.
Bryan Hanson:
Yes, just going to say, and you are right, I mean the two areas where we're spending a lot of time right now when we look at targets and are pulling that bolt-in of targets, it would be around enabling technology. A great example of that is what we did with Canary in that relationship that's been created, and that's going to then obviously spin out IQ for knee, but also sensors and other areas and body as well. And then we'd be looking at near adjacencies very much like what you've seen recently from us in sports to ASC, thoracic areas that we feel confident we have a right to win. They are accretive to our overall weighted average market growth and they're profitable. Those are the things that we're looking at today. And as Suky said, the firepower opens up and we'll begin to flex that firepower in those areas.
Rick Wise:
I just as a follow-up, I was reflecting, Bryan, on your comment about -- specifically about revision where you said capability now opening the door to competitive conversions. I was reflecting just that maybe you could flesh out your comments here. I mean, I get it that revision specifically will help, but -- so Persona iQ so well continuing rollout of ROSA, et cetera, et cetera. Just my question is, as we reflect on the next 6, 12 or 18 months, what should we imagine? What are you thinking about as the biggest driver of competitive conversions and share gain, is it these incremental products? Is it the totality of everything? Is it something about execution? Just trying to understand where you'd have us focus on thinking about that kind of a concept?
Bryan Hanson:
Can you hear me okay? What I would tell you is that the -- that's kind of the beauty of the situation why my confidence is high that we're going to continue to see share gains as we have over the last four quarters spot. That's because we just have so many shots on goal. If you think about knee in particular, we already have ROSA out, and that's getting great traction ROSA Partial was just launched. Persona revision has been out for a while, but the momentum is still very strong. And there is that spin-off opportunity to get the typical total knee. You still have mymobility driving conversions. You haven't even launched Persona iQ yet. So all of these give us an opportunity to create a differentiated environment for our customer and provide the opportunity for not only that share gain or mix gain, but also competitive conversions. And specifically on revision, the reason why I bring it up is typically in somebody's practice, you get about 10% of the overall revenue associated with provision, and it's more like 90% comes from your typical total knee. And many times, we use that revision as a tip of the spear to convert a surgeon that is a competitive surgeon because they love the revision system. And that gets us in the house then to try to pursue that much larger portion of the business, which is your standard knee. So that's why I keep going back to that, we have significant dollars now that we're paying attention to, where we have a revision customer that is using a competitive total knee system, and that gives us a great opportunity and kind of a hunting ground to go to, to get those conversions, but it's certainly not the only area that would give us the opportunity to take share. It's pretty much all of these.
Keri Mattox:
Lauren, we probably have time for maybe one more question.
Operator:
Up next, we have Matthew O'Brien with Piper Sandler.
Matthew O’Brien:
Thanks here. So Bryan, just a little bit more on the knee side of things. When I look at your numbers, I know what you're saying about over the last several quarters, you're trending in the right direction. But when I look at the last two, it seems like things have flattened out a little bit. If not, you're actually down a little bit on the knee side in terms of share. And so I'm just wondering, especially in the U.S., that's actually down versus '19 here in Q2. Are there things that are impacting you specifically because you are the biggest player in the market? Are there some higher volume accounts that are on vacation? Are you in bigger COVID hot spots more training on the partial knee side that has slowed things down a little bit for you guys versus what we've seen from some of your peers?
Bryan Hanson:
It's so hard to say. And that's why I was referencing before when I look at share gain or loss, I never look at and spend too much time on a specific quarter, even when things are typical. But in these crazy times, so many things can impact your performance versus the market. So again, I try not to get too worked up about any given quarter. It could be. I mean the fact is share right now in a specific part of the country for instance, can be meaningful to whether you do better or worse than the competition because that particular state or county could be challenged by COVID more than others. So there's always those things that could impact a specific quarter. That's why when I look at over a four quarter period of time that usually eliminates those hotspots. And that's why I feel more confident and more comfortable with more of that trend, which -- through that trend basically eliminates the noise, I'm going to put air quotes around the "noise" of a specific quarter. That's why I still feel confident that we're in good shape that we have all these shots on goal that we should continue to take share. But hey, I'm disappointed. I look at the quarter, I don't really care what the reason is. I want to win every single quarter and this one we didn't. But again, I'll look more at the trend and take more from that on the prediction of share taking in the future. And I would just say in a nutshell, I believe that we're going to be net share takers.
Matthew O’Brien:
And then just really quickly on ROSA placements. I think you mentioned more -- a better trend line on the OUS side. So can you just talk a little bit about what you're seeing internationally as far as ROSA placements go? And then here in the states, there's been some talk about some moving into ASCs. And just in terms of ROSA placements, what are you seeing in terms of where these things are going higher volume accounts that you're getting into inpatient or even in the ASC or even on the ASC side of things?
Bryan Hanson:
Yes, that's a nice thing. I feel really good about our distribution. We're taking advantage of momentum in the ASC. The ASC absolutely loves the fact that we're an efficient robotic system that they're all about efficiency in the ASC. So there's been a benefit for us there for sure. We've seen it in the hospital as well. We've seen it around the globe in Europe, Middle East and Africa as well as Asia-Pacific. So I'm just very pleased with the distribution of the technology across pretty much all sites of care and around the globe. And again, we focus our attention, not always, but let's call it, 80-plus percent of the time in those larger accounts. We're spending our time in those goals and platinum accounts because that's where the big payback is if you're going to spend the time. So again, the distribution has been good. I mean it's been across settings, across region, and we've been focused on the larger accounts for sure.
Keri Mattox:
Thanks Matt for the question. And I think that brings us to 9:30. Bryan, I'll turn it back over to you just for any closing remarks before we wrap up.
Bryan Hanson:
Yes. Thanks, Keri. I wouldn't mind making a couple of comments here. And first of all, thanks for spending time with us here this morning. I just want to say, and I think this is probably obvious to everybody. We certainly have an outsized dependence on elective procedures versus really any of our med tech peers or competitors, particularly large cap companies. We're just an outsized impact there. And as a result, we're very sensitive to COVID ebbs and flows. And we spend a lot of time as you would imagine, analyzing this. And we try to remain prudent in our expectation setting as a result. And because we've seen it. We've seen it first hand that COVID can move our business pretty rapidly given that dependence on electric procedures. And this has been what was reflected in the updated guidance and why our implied range for the back half is still pretty wide because again, there are things that can happen here to move us up or down pretty rapidly because of that dependence on elective procedures. Now relative to Q2 specifically, and Suky said this before, even with some of the unexpected challenges that we had in the quarter, hey, we delivered better-than-expected results, which I think speaks to two very important things. Number one, and this is more short term, but it's important, the recovery from COVID is moving in the right direction. Now it's definitely not happening the way we anticipated. I don't think it is for anybody. But it's moving in the right direction, nonetheless. And the two, and I think this is important, not just for now, but the long term, our team continues to execute and deliver against the things we can control and both of these things were deeply considered in our updated guidance. And this gives us confidence that continued recovery through the back half of the year is going to happen. And we see a path to end 2020 at 4% to 5% organic growth, at 4% to 5% we've been talking about without the need for any material benefit from clearing the deferred patient queue. And I got to say, given where we started just a few years ago, and with COVID in between, with very flat to negative growth with consistent share losses as a company. I for one, is super proud of the team for putting ZB in this position. And I look forward to not just talking about it, but delivering it for you our customers and our patients. Okay. With that, we'll go ahead and end the call, and we look forward to talking to you again soon. Thanks so much.
Operator:
Thank you again for participating in today's conference call. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet First Quarter 2021 Earnings Conference Call. [Operator Instructions]. As a reminder, this conference is being recorded today, May 4, 2021. Following today’s presentation, there will be a question-and-answer session. At this time, all participants are in a listen-only mode. [Operator Instructions] I would now like to turn the conference over to Keri Mattox, Senior Vice President, Investor Relations and Chief Communications Officer. Please go ahead.
Keri Mattox:
Thank you, Operator, and good morning, everyone. I hope you are all well and safe. Welcome to Zimmer Biomet's first quarter 2021 earnings conference call. Joining me virtually today are Bryan Hanson, our President and CEO; and CFO, Suky Upadhyay. Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by the forward-looking statements due to a variety of risks and uncertainties. Please note, we assume no obligation to update these forward-looking statements even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties, in addition to the inherent limitations of such forward-looking statements. Additionally, the discussions on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within our Q1 earnings release, which can be found on our website, zimmerbiomet.com. With that, I'll now turn the call over to Bryan. Bryan?
Bryan Hanson:
Alright, great. Thanks, Kerry, and I also want to say thanks to everyone for joining us this morning for our call. And before we actually get into the Q1 numbers and our guidance, I just want to take a second to say that I certainly hope that all of you and your families are continuing to stay safe. We're obviously very pleased to see that so many people now have access -- full access to the COVID-19 vaccinations, and that adoption has been pretty strong so far. Now, of course, we'd like to see this even more broadly on a worldwide basis, but it certainly feels like we're making really important progress toward moving forward. And ultimately, as a result of that moving hopefully on from the pandemic. Now it's not over, and I think all of us realize that. But I for one feel more optimistic than ever that we're coming out, I think on the other side of COVID-19. And with that, much better days ahead. And I guess with that, probably it's a good lead into our Q1 call. Q1 was a stronger quarter than we initially expected, and I'm pretty excited to discuss it with you, Whenever you have a good quarter, obviously earnings calls are a lot more fun. So clearly, we're excited about this one. And I'm going to try to keep my remarks relatively brief, this way I know you're kind of laughing at that because it's not always easy for me to do that. But I'm going to try to keep it brief, and that'll give Suky an opportunity to walk you through which you're really interested in, which is the financial results for the quarter, and really how that translates into our expectations for the full year 2021 guidance, and I also want to make sure that we leave time for questions, obviously. So I'm just going to stick to really three topics as a result. Number one, I want to talk about the COVID recovery just briefly, and our execution inside of that recovery. And then ZB's ongoing transformation and our progress against that, and that will be the second topic, and the third topic would just be around her long-term growth strategy just reiterating our position there and how we believe that's going to drive value for our shareholders and stakeholders overall. So let's start with navigating COVID and how we're executing inside of it. COVID clearly is not over, just as I stated a minute ago. I'm very confident, we're going to continue to have surprises ahead and disruptions ahead, but based on what we saw at the end of Q1 and what we're seeing in the beginning of Q2 and coupling that with the just the pace of vaccine rollouts right now, we're clearly moving in the right direction. I don't think anybody can argue against that, and it's that shift toward what I would define as more stability. And I know it's on a relative basis when I talk about stability here, but that shift towards more stability really enabled us to give you the full year 2021 financial guidance. Now inside of that guidance, there's going to be some important assumptions about trends and recovery timing that underpin our outlook. And Suky is going to get into more of that in just a few minutes. But overall, it feels good, feels good to have better insight into the broader market and greater confidence in what the rest of 2021 should look like for our business. Now as we start to return to a more normal environment, I'm going to put "normal environment in air quotes given the situation right now,” but when that happens, we expect that part of what we'll see is a pretty significant tailwind from the backlog of patients that has built up over the last year or more. Now, how fast that happens, how fast we work through that backlog, especially across certain regions is something we're going to have to pay attention to. You’re going to have to watch and track, but we absolutely believe that the vast majority of those patients who put off an elective procedure will come back into the funnel, and that's going to provide a significant tailwind well into 2022, and I for one cannot wait for that tailwind. And I can tell you that ZB is ready for them. They're ready for those patients, and we're ready to be able to help our customers, care for those patients. Speaking of being ready, as I've said to you before, the things that ZB was able to directly control over the past year, I truly think the team has executed against, and I'm very proud of the ZB team for how they stood up and delivered against a backdrop of a whole lot of things that were absolutely out of their control. And I know I talk a lot about the importance of our talent, our mission, our culture here at ZB, and I can say that each word is absolutely critical for us in 2020 and continue to be in 2021 and well beyond. And with that in mind, we've made some additional changes to our leadership team here very recently. We've added a Chief Transformation Officer, again, to help us with all the transformation that we're going to continue to have as an organization. We've appointed a new Chief Human Resource Officer to help us move our talent agenda forward, one of the key areas of focus for me as we move forward as an organization, and promoting Sang Yi to Group President of Asia Pacific, he's now going to have some responsibilities of certain projects, OUS. He brings a real disciplined execution mindset, and he can absolutely help us outside of Asia Pacific. And then expanding Ivan Tornos' role as a Chief Operating Officer with the added leadership now of EMEA, which is a region that he has had deep responsibility for in the past and knows very, very well. And I know it can bring us value in that region. So, I can tell you this continued focus on talent and development is not just contained to the executive ranks. Our entire ZB organization is hyper-focused on our people, on really getting the right team members in the right roles and giving them the tools and support, and really the opportunities to drive their performance, to develop and excel. And it's working, I can tell you, this focus on talent is working and I believe it is going to continue to set us apart from the competition. And in addition to the foundation built by our team members, our mission, our culture, our core business momentum is stronger than ever. The team's execution continues to be on point. Our market momentum is building, our commercial competence is higher than ever. And I can tell right now, we are very excited about the R&D innovation pipeline that we still have coming. That's an important part of our revenue growth. Throughout Q1, and even in recent weeks, we've hit key milestones with our ZB products and our innovation. The application for partial knee now is available for ROSA, we just approved by the FDA. We've actually already had our first procedure using that application last week with very good results. And this is just the latest addition to our ROSA Robotics program, our platform here. And it's also another launch inside of our ZBEdge suite of integrated digital and robotic technologies. Again, something we truly do believe will set us apart from the competition. So if I just look at ROSA overall in the quarter, we continue to see strong market demand and traction with our ROSA platform. The Q4 performance was fantastic, and that continued right into Q1, both in the U.S. and internationally. And our forward-looking robotics pipeline is very robust. And I can tell you that given our market share in partial knee, the partial application is only going to serve to bolster that going forward. For Persona Revision, another strong performance, this continues to move forward in an amazing way. Q1 was ahead of our expectations. And it is another example of a tip of the spear product that we have that as we make the conversion of revision, we also have the opportunity then to go after the standard new business as well. So again, still exciting opportunities there for revision. And then our Signature ONE planner for shoulder procedures, again demonstrated a very strong sequential growth from Q4. We're actually up 65% over Q4, when we look at registrations, again, that's a pretty significant move. And again, this provides that stickiness with our customers in that procedure. But, it also provides a mixed benefit wherever that pre-surgical planning is used. As we come into Q2 and the rest of 2021, ZB has additional innovation that's coming, and it's pretty exciting innovation with our anticipated launch of Persona-IQ and also ROSA hip later in the year. And I can tell you for Persona-IQ, the initial feedback from evaluating surgeons has been very positive. And I can tell you that they're interested in being able to capture data from inside the body. And this is unique, they've not been able to do this before. And then ultimately, remotely monitoring those data and the hope would be that using that information to change the way that we care for patients. So the excitement around this is very strong from our surgeons. And we can tell that the momentum is going to be strong when we do get regulatory approval. So all that to say the momentum on the innovation front is real here at ZB. This will allow us multiple shots on goal across a number of innovations, again with multiple robotics launches, continuing success with Persona Revision, Persona-IQ, new iterations of mymobility, and just really the broader ZBEdge ecosystem to drive mixed benefit for sure, but also competitive conversions. And ultimately, we really believe change the way that we care for patients, change the treatment paradigm for patients. That's really what it's about. It's about driving the mission of this organization, truthfully to remove pain from patients around the world and improve the quality of their life. And we truly do believe ZBEdge can help us do that. Okay, so let's move to the second topic that I have for you this morning. And that's the continued transformation of ZB. Now, you've heard me talk about the three phases of transformation. The first was winning the hearts and the minds of the organization of the team members, and really dealing with the execution challenges that we had that we spent a lot of time on in the first year. And then second was moving to that longer-term, firm strategy for the organization that would drive innovation, it really building the structure around that strategy and the operating mechanisms to ensure that we move it forward. And then third, where we are now is the portfolio transformation. And truly, that is where we sit, that is squarely where we are positioned today in Phase 3 of these three phases. And we have the ZB portfolio management strategy and process in place. And we have definitely built out our capabilities to move forward in this space. We're focused on what we're going to define as mission centric M&A, that is whenever repeated, that would absolutely increase our weighted average market growth and does not disrupt our best-in-class margin profile. And as you've seen, we've moved this forward already, with selected tuck-in acquisitions that we did last year. And that really does illustrate the strategy of work. And those deals were smaller, no question they're smaller. And they're relatively immaterial when it comes to the initial revenue that we acquired. But they're absolutely designed to fill portfolio gaps and better position us in high growth markets. Those high priority markets and sub-markets, where ZB has a path to leadership. And we believe a right to win in markets like sports medicine, ASC, and in the sternal closure market for us. And each of these deals gives us a gap filling, and we believe differentiated product portfolio to drive growth. And that's important to growth, but also to drive additional confidence in our S.E.T. business category. And of course, inside of this active portfolio management phase, there's a planned spin-off transaction of our spine and dental business that we discussed back in Q4. That process of creating two independent, even stronger companies is on track. It's early days, obviously, but it is on track. And as you saw from our Q1 results, we do not believe it's causing distraction or disruption in our business. In fact, it's more of the opposite. We've seen significant energy in the business to kind of jelling in the business, as a new co-team starts to come together, under CEO Vafa Jamali, and they begin to build out their own strategy and their focus. So again, it's early days, but we're very happy with the progress so far of the spin. Alright, so that brings me to my third and final topic this morning that really around our ZB plan to drive long-term growth in ultimately deliver value as a result of that growth. And I can tell you that we remain fully committed and confident in ZB's long-term growth and margin expansion expectations. We've said before, and we'll say it again, that the spin-off of NewCo actually serves to de-risk and potentially accelerate our path to mid-single digit growth, and a best-in-class 30% operating margin profile by the end of 2023. And we're confident that throughout this process, and as we achieve this growth and margin profile, we're also going to have the flexibility to reinvest for growth. And that is a key thing for us. We've got to continue to be disciplined, but ultimately invest for growth in this business. And that's what we will continue to do. Now to get these growth levels and to achieve our top quartile performance in TSR, which I think you probably remember, is one of our strategic pillars. Now we're going to continue to execute in our priority growth areas. And just as a reminder, that means that we expect to drive above market growth sustainably in these, we plan to grow hips consistently at market, but then later this year, above market rates when we launch the ROSA hip application, and we expect to stabilize first and foremost, but also drive focus. And then ultimately, through that focus drive our S.E.T. business at the higher end of market rates there. We're also very focused on driving change for ZB, a real evolution of the company from a metal and plastic provider of implants to a leading med tech innovator. Think of us as a high-tech company that happens to be in med tech. And that's the ZB brand that we're looking for that brand evolution of this company. And I can tell you that already, more than 70% of our product development dollars are being spent in this area, being spent on ZBEdge, that ecosystem of connected technologies. Now, we're always going to be an implant company. And that's the center of the universe for this company. But the ZBEdge ecosystem around it is a way that we can differentiate ourselves versus the competition. And we already have exclusive relationships to help us here. We have relationships already with Apple, and several other tech companies that we truly do believe will drive future innovation that will delight our customers and ultimately benefit patients. And I believe fundamentally, that this shift is coming not only for us, this technology shift not only for us, but for the entire market that we play in them. And I truly do believe that the technology advancements potentially can reshape the growth curve of these markets. I'll say that, again, I think the technology advancements that we're seeing and the value they bring can reshape the growth curve of the markets that we play in. And I think very importantly, also change the care paradigm for our customers and their patients. Alright, let me close by saying that I continue to be highly confident in ZB team, and in our business momentum. I truly believe that we are well-positioned for success and our strategy is working. Our transformation is well underway. And I'm excited about the value that we can drive for our shareholders on a go forward basis, I truly am. And before I hand it off to Suky, I just want to take a minute to say thank you, truly thank you to the entire ZB team. Your vigilance and dedication to our safety protocols over the past year or so has been absolutely critical. And you're focused on our mission, our strategy, and really just how you show up and execute every day, it's unmatched in my view. It truly is unmatched. You are what makes us ZB, I truly believe that. And what makes me confident who really is that we can absolutely continue to deliver on all fronts. Okay, so with that, I'm going to turn the call over to Suky. He's going to give you more financial details on the quarter and obviously most importantly, our expectations looking forward. Okay, Suky?
Suky Upadhyay:
Thanks, and good morning, everyone. As Bryan mentioned, our underlying fundamentals remain strong, as does our confidence in our outlook. For this morning's call, I'm going to focus on three topics. First, our Q1 results, including commentary on the impact of COVID, second, how that translates into our full year 2021 financial guidance that we provided this morning, and third, how ZB is positioned for long-term growth in 2022 and beyond. Moving forward, unless otherwise noted, my statements will be about Q1, 2021, and how it compares to the same period in 2020. And my revenue and P&L commentary will be on a constant currency or adjusted basis. Net sales in the first quarter were $1.847 billion, reported increase of 3.6% and a constant currency increase of 80 basis points, versus the same period in 2020. It's important to note that we had one fewer selling day resulting in approximately 150 basis point headwind to consolidated revenue growth. Overall, consolidated and regional results were better than our initial expectations, as vaccine adoption continued to ramp up, and pandemic pressure eased across most markets in March versus January and February. First, the Americas increased 1%. We continue to see variability by country, and while the region was in decline for most of the quarter, a sharp increase in U.S. procedures in March drove regional growth. As expected, the EMEA region was hardest hit by COVID-19, decreasing 10.3%, with all sub-markets in decline. While we did see some recovery or decrease in COVID pressure as we move through the quarter, some markets continue to operate under recently enacted restrictions and actions that are limiting the near-term recovery of elective procedures. So, we're continuing to monitor uptake very closely, and expect that recovery in EMEA will lag other regions by one to two quarters. Lastly, Asia Pacific grew 15.5% with solid year-over-year growth across our three largest markets. Overall, we've seen a stabilization around COVID cases and surges in the region, but, we continue to see some significant delays and recovery across India and other smaller markets. Turning to our business performance in Q1. Before jumping in, let me call out that we've updated our product category reporting to provide visibility into NewCo, to align products to categories based on how we internally evaluate performance of those businesses. Also, we have adjusted our historic reporting of revenue for these changes to assist in year-over-year comparisons. First, our ROSA Robotics capital revenue has been moved from the knees category to the other category. And, our disposable revenue associated with robotic knee procedures have been moved from the other category into the knee category. This will allow us to more clearly indicate to investors the growth of our base knee business, and sets us up for reporting once we launch ROSA Hip, which is currently expected in the second-half of 2021. We've also broken out our global spine and dental revenues this quarter in conjunction with NewCo reporting. And as a result, CMFT is now included within S.E.T. The global knee business declined 5.2% versus Q1, 2020, negatively impacted by ongoing pressure from COVID. Inside of that, we continue to see strong momentum from Persona and from ROSA Knee. Our global hip business increased 0.3%. Both the Americas and Asia Pacific continue their growth trends increasing 0.9% and 11.2%, respectively. We continue to see strong demand and favorable feedback on the Avenir Complete Hip with adoption from both gold and platinum accounts. Sports, extremity and trauma increased 7.2%, driven by solid growth in upper extremities, trauma and CMFT. In S.E.T., we continue to see strong surge in registrations of the Signature ONE surgical planning system for soldier procedures. Our dental and spine segment grew 9.6% fuelled by outpaced recovery, especially in dental. New products and better commercial execution also drove growth in the quarter, with strong contributions from implants and digital solutions in our dental business, and from Mobi-C and Tether within spine. Finally, our other category was down 2.5%. As mentioned earlier, this quarter our other category includes the contribution of ROSA Knee capital sales. Moving on to the P&L. In the first quarter, we reported GAAP diluted earnings per share of $0.94 and adjusted diluted earnings per share of $1.71. Our reported GAAP diluted earnings per share were up significantly when compared to a reported GAAP diluted loss per share of $2.46 last year. The increase in year-over-year GAAP earnings was driven by higher revenue in the current period in tandem with prior year goodwill and product liability related charges. On an adjusted basis, EPS was up about 60 basis points, driven by higher revenues with operating margins down slightly compared to 2020, and a higher share count. The adjusted tax rate of 16% in the quarter was better than expected, driven by the realization of excess stock compensation benefits and other smaller discrete items. Turning to cash and liquidity, overall operating cash flows were $247 million and free cash flow totaled $137 million for the first quarter. We paid down an additional $200 million of debt, and ended the first quarter with cash and cash equivalents of $724 million. We continue to make good progress with another quarter of delivering the balance sheet. Moving to our full year outlook and financial guidance. While we continue to see pressure due to the global pandemic, vaccine rollout and adoption is approaching meaningful levels, translating into a reduction of infection surges and hospitalizations in most markets. This increased stability gives us greater confidence that we'll return to normalize market growth in our key markets within the year, and also begin to see deferred patients re-enter as an added tailwind. As a result, today, we provided financial guidance based on our latest expectations, and that is underpinned by two key assumptions. First, current vaccine adoption trends continue to strengthen, driving a decrease in the number of new COVID-19 cases through 2021. And second, hospitals increased capacity to work through some portion of patient backlog this year. Against that backdrop, our current expectations for full year 2021 financial results are
Keri Mattox:
Thanks, Suky. [Operator Instructions] With that operator, may we have the first question, please?
Operator:
Thank you. Ladies and gentlemen, at this time, we will now begin the question-and-answer session. [Operator Instructions] We'll take our first question from Mike Matson with Needham & Company.
Mike Matson:
Hi, good morning. Thanks for taking my questions. I guess, I wanted to start with the backlog that you mentioned. If your sales were down about 12% in 2020, does that equal to 12% around $1 billion for the backlog? And then, where do you think the capacity is among surgeons and hospitals to address that, and how much have you factored into your guidance for this year?
Bryan Hanson:
Yeah. So, thanks for the question. So, I would say it's not as simple math as that, but it's pretty close. Because you've got to remember, certain portions of our business would not have patients that would have a disease state that continues to – [indiscernible] to deal with, and so not all of our revenue then is linked to procedures that have been deferred. But, if I take those that are, and we also have kind of a percentage that we would assume will drop out of the funnel, we still have a very sizable backlog, hundreds of millions of dollars. So maybe not quite the number you're referencing, but the math logic makes sense when you peel out some of those old pieces. Now relative to the cadence or speed at which we're going to digest those patients it is difficult to predict. I mean, we've never experienced anything of this size and magnitude in global impact. And so, I don't know that I have a perfect proxy to determine how quickly we can actually work through that backlog of patients, but my general feeling is easy to look at just historical views of this, although much smaller and different. It's usually 12-months to 18-months, you typically work through a backlog funnel. My guess is it will take at least that long, given the size and the magnitude of the backlog that we're talking about here. And it's going to be different. It's going to be different depending on where you are in the world. Certain places in the world will move that backlog through much faster, and other places will go a lot slower, because the incentives are not there just to be able to digest again that patient flow as quickly. So again, I guess the takeaway is, it should be a very large backlog of patients. That will be pretty substantial dollars for us to be able to take advantage of this tailwind, but the timing of that, the speed at which we work through is, we're just not sure yet.
Mike Matson:
Thank you.
Bryan Hanson:
Absolutely.
Operator:
Our next question comes from Bob Hopkins with Bank of America.
Bob Hopkins:
Great. Thank you, and thanks for taking the questions and I appreciate those prepared remarks, Bryan. There is a lot to unpack in there. But for now, I'll keep my questions a little bit short-term just given how confusing an environment it is. When Stryker reported, they said their hip and knee results for April were kind of already rebounding to up mid-single digits year-over-year. And I'm just curious directionally, if you're seeing sort of a similar thing here in the first part of the second quarter.
Bryan Hanson:
Maybe what I'll do is toss that one over to Suky, as he's going to give more color around either guidance or just what we're seeing going forward. So, Suky, do you want to take that one?
Suky Upadhyay:
Sure. Hey, Bob, good morning. So, before I get into Q2, I think it's important to reflect on Q1 for a moment. Versus 2020, we were up just under 100 basis points versus the prior year, better than our commentary earlier in the quarter where we expected to be down low-to-mid-single digits, and that was really because of the sharp uptake, as I talked about in March, primarily in the U.S., and we saw greater stabilization, faster stabilization in Asia Pacific than we expected. That more than offset a lingering headwind or below expectations for EMEA. Versus 2020, things get a little bit choppy because of the comparisons to prior year and COVID. But if you look at Q1 versus 2019, we were down and that implies about 8%. And as we exited March, we were also down versus 2019. Now, our guidance moving forward when compared to 2019, assumes sequential improvement in growth rate in Q2, Q3, and Q4. So far as we've entered into Q2, we've got confidence in that shaping for Q2. We expect to exit the second quarter at about 2019 levels, not for the full quarter but as we exit. And inside of that, we expect Asia Pacific to be above Q2 of 2019, the Americas about flat-to-slightly up, and EMEA continuing to lag. And again, the early start that we've seen so far in the second quarter, gives us positive proof points and confidence that we'll see that sequential step up in the second quarter.
Bob Hopkins:
Okay, that's helpful. Thank you. And then just for a quick follow-up, can you give us an update on the timing for Persona-iQ and your thoughts there in the U.S., and timing of that approval and launch?
Bryan Hanson:
Yeah, sure. We're actually waiting for the FDA approval right now. We're ready to go, obviously we're prepared and ready to launch. We've worked through our commercialization strategy. We did a really nice job about complements team here in getting a third-party engagement to do a pretty comprehensive survey of what we could expect upon commercialization price points, what people are willing to pay for it, and how interested people are for the data capture, and using that data from a remote patient monitoring perspective. So, I think we're really well-prepared for the commercialization. But at the end of the day, you can't do anything until you get the FDA approval. So that's what we're waiting on. And when we get that, we'll be moving forward. My guess is, we'll be able to launch this over the next handful of months. But what I would just emphasize is right, this is a unique launch for us, it's first of its kind. We're going to take our time. We're going to do a limited launch this year. I wouldn't expect material revenue in 2021. The full launch would really come towards the end of 2021 or 2022. But we really want to make sure that we're concentrating on a few customers, going deep with those customers, really understanding data capturing the value that it brings, and then from there going in a more widespread way. Now, if we pick up information quickly and our confidence level grows more quickly than we're expecting, then you could see a difference this year than what I'm predicting right now, but I would think about it as launch this year, obviously, more limited in the way we would do that launch, and then a more aggressive launch, more full launch as we come into 2022.
Bob Hopkins:
Great. Thanks, Bryan. Thanks, Suky.
Bryan Hanson:
Yeah.
Operator:
Our next question comes from Jason Wittes with Northland Capital.
Jason Wittes:
Hi, thanks for taking the question. Maybe follow-up on Persona-IQ. You actually mentioned, I think, 70% of your innovation pipeline is IT data-driven. I assume Persona-IQ is part of that. I'm just curious in terms of how you see that playing into the marketplace, which is simply share gains, ASP gains. And then related to that, if you look at traditional ortho implants, they take about a year or so before they really impact the revenue line. Is that the kind of time I mean, you kind of laid that timeline out for Persona-IQ, but for some of the other products in the pipe should we expect it takes about a year or so plus gestation, before it really matters, I guess?
Bryan Hanson:
For us, I think it matters right out of the gate. To me, I look at this as first of all, absolutely, IQ was part of that stand that I talked about for the ZB ecosystem, right. And I think about ZBEdge, it is a very unique part of it, too. As I said in my prepared remarks, we're an implant company. This is where our bread and butter is for sure. But what we want to do is, we want to elevate beyond that to make sure that we've got an ecosystem around it. And IQ, although extremely important in that is a variable in the overall equation. You still got mymobility that we connect with IQ, which would connect with ROSA. And OrthoIntel is kind of a backdrop to that, and would allow us to be able to collect data on a patient before surgery, interactively post-surgery, and then be able to use those data ultimately to change the way we care for the patient. And that's what's so exciting about it. And so, I think you can't really compare this to a typical knee implant or another implant. And the timeline it might take up to drive real traction or materiality in the market, because it's that unique. It really is a connection point to this broader capability that just does not exist today. So it'll be interesting to see. We've got a pretty, pretty ambitious plan that we have in front of us. And the feedback so far from our valuating surgeons has been very strong. And just generally in the marketplace, this desire to have data and be able to use the data to have better insights to be able to provide different care, better care is real. And ultimately, what we're so excited about is, as we collect data right out of the gate, we're first to market obviously with a smart implant. But as we collect data, we'll stay out ahead of folks, because that data is really where the magic is. The implant is interesting. You can listen to it right away. But as you collect a certain amount of data over a period of time, that is actually what provides the insights that are going to matter in the future. And so that gives us an opportunity to stay ahead. So we're very excited about it. It is part of that R&D spend. And we believe that it has the opportunity to have a better ramping curves than in a typical implant, just because it's so unique.
Jason Wittes:
Okay. And then just a quick follow-up, you guys mentioned in your guidance you prefaced on the fact the idea that the hospitals are going to be able to increase capacity. I guess, have they indicated that months COVID clears, they're ready to basically double up or what have you? And should we assume that is something that really happens towards the late third, fourth quarter in terms of when we might see that bump?
Bryan Hanson:
Yeah. So, what I would say is that it really varies depending on which customer you're talking to, what part of the world you're talking to them in. But, Suky maybe you could just provide a little more color on that, just to give a view of how we're thinking about the back half, and our view of how much backlog or not come through in the back half.
Suky Upadhyay:
Yeah. Sure, Bryan. So Q2, again, we expect to be sort of a transitional quarter as we get into the back half of the year, guidance assumes sort of normalized growth rates to historic levels, or '19 levels. Inside of that, we would expect if you looked at sort of the midpoint of our guidance range, that, first of all, we expect COVID to continue to linger in many markets within the second-half of the year. But broadly offsetting that will be some additional capacity that comes through hospital systems and other markets to basically net that out. And that's not uncommon. We saw that in the third quarter of last year, when we look at our results as COVID was stabilizing, you saw hospitals actually increased their capacity to start to bring that backlog through. So again, at the midpoint of our range, we kind of assumed that lingering COVID is out there in certain markets, but that's offset by additional capacity in other markets. So net-net, you're effectively keeping your backlog steady. For the bottom end of our range, we assume that COVID has a bigger impact than that backlog pulled through. And at the upper end of our range, we assume that backlog capacity, more than exceeds the COVID pressure that we expect to see lingering through the second-half of the year. So that's kind of how we see, again, we did see those proof points in the third quarter of last year. And as we expect to see, pull-through through this year and the backlog we expect it to resemble very much what we saw in the third quarter of last year.
Jason Wittes:
Very helpful. Thank you very much.
Operator:
Our next question comes from Jeff Johnson with Baird.
Jeff Johnson:
Thank you. Good morning, guys. I wanted to go to the spine and the dental segment if possible. I don't think I heard specifics on one versus the other, other than dental kind of led that growth. So Bryan, any way to break that out for us? And then in the cervical disk space, you called out Mobi-C. You are seeing some good traction from a 10% competitor in the space. You got a new two level approval from another competitor. Just what's your outlook on the cervical disc side that would be helpful as well? Thanks.
Bryan Hanson:
Yeah, absolutely. I won't give specifics between the two businesses, but just know that both businesses did better than we expected in the quarter. Dental definitely was a stronger of the two. But, we know we're excited about seeing that progress. And it was a big, important quarter for us. Because, remember, this is really the first full quarter, when the organization knew about the spin, really understood the spin. And there was always that risk, obviously, when you announce something like that, there could be some disruption. As you can tell, we're not seeing disruption, if anything, we're actually seeing momentum, which is great. But, I would say on the cervical disk side, I kind of like the idea of others entering the market, because ultimately, I truly do believe that cervical disc is a better way to go in fusion. So if we have more people entering the space talking about it, I think we've got an opportunity to convert more of the businesses out there today in fusion, that's really the target. If we can increase the size of the cervical market, that's a good thing for everybody, good thing for patients, good thing for the overall business. And it's an area we're going to continue to focus on. We're going to make sure that we shore up the customers that we have today, but we're going to continue to sell, and proactively get conversions. Another big opportunity for us in spine is the Tether. I mean, it really is a unique technology for us, it helps scoliosis patients in a way that they cannot get otherwise. And that product is on fire, it's doing a great job. And it's extremely mission-centric to the organization. So that just kind of gives you a general overview. Again, happy with both businesses, dental was stronger in the quarter, but spine did also well.
Jeff Johnson:
Fair enough. And then maybe a quick follow up on IQ. Any timelines on actual reimbursement pathway on the monitoring side, just how to think about that getting reimbursed? And is that really going to be the rate limiting factor uptake of that product? Or do you think you could without monitoring reimbursement still sell the IQ product? Thanks.
Bryan Hanson:
Yeah. I think it would be nice to have for sure. In reality, it already exists. So, we believe that it will be something that people will be able to access, but we're going to make sure that we get smarter on that topic and help our customers understanding that detail as well. We don't believe it's the requirement though for uptake, I really do believe that people see this as an opportunity to capture the data, and through the data, be able to provide better care. A couple things that I would say about that is, this is just the beginning. We've had a very strong relationship with Canary. It's a relationship that will go on for many, many years. And, it's not just -- it's going to be for hip, it's going to be for shoulder, there's going to be a whole pipeline of technologies that will launch. This is just the beginning of the beginning, if you will, for sensors. And this idea of a closed loop is being able to have mymobility applications in each of the areas that we play, having smart implants, as well, having ROSA applications, having OrthoIntel that connects the dots across those, that is something that, ZBEdge ecosystem that we're going to use in each of the areas that we play. So we're pretty excited about it. And so, I guess, to sum it up to say, the remote patient monitoring reimbursement is a great thing to have, and I think it's warranted, but it's not the reason why we believe we're going to get up thinking this. We truly do believe it's the data capture and what that data can tell us what's going to drive it.
Jeff Johnson:
Thank you.
Bryan Hanson:
Sure.
Operator:
Our next question comes from Robbie Marcus with JPMorgan.
Robbie Marcus:
Great. Congrats on a really nice quarter. Maybe just two quick ones for me. One, you did the restatement, and I think it helps give us a little more clarity. But, there was a bit of movement out of knees and into other and other into knees. I was wondering if you give us any sort of net number on what ROSA was? And then I'll just ask the follow-up as well. Really strong operating income results, but free cash flow and operating cash flow came in a bit lower than I was thinking. Any color there and how that should progress over the year? Thanks.
Bryan Hanson:
So Suky, maybe I'll toss that one over to you, and then maybe I'll take the follow-up.
Suky Upadhyay:
Yeah, sure. So on the restatement, first of all, good to talk to you, Robbie. We did do it to provide a little bit more color into what's happening in our base knee business. So you've captured the moving parts correctly. We provide a lot of detail as to what those comparisons are. We're not going to break it down much further. But if there are additional questions after this, our IR team is happy to go through any additional quarterly breakdown. But overall, we think that that's a good move, especially in the backdrop of -- we hope are going to be some expanding and growing indications for ROSA Robotics. So this will help clarify what's actually happening in those underlying indications relative to based business and capital sales. Cash flow, overall, operating cash flows were about $245 million, with free cash flow about $145 million. It was a little bit lower than we had last year. Remember, that first quarter is seasonally lower than other quarters throughout the year. That's primarily because we have a lot of big payments that have in the first quarter around prior year rebates, as well as employee bonuses. There are a number of other things that happened in the first quarter that seasonally make that number lower. In this quarter, two key things. One is we built some excess inventory. So working capital was higher. We do see a market recovery coming later this year. And we want to make sure that we've got a sufficient supply to meet that market demand. So one, we think that that was the right move. Secondly, from a working capital standpoint, receivables were a bit lower than expected. If you remember, we had a pretty low fourth quarter of last year, that income or that cash comes in the first quarter of this year. And because of those lower sales, you're seeing less cash receipts in the first quarter of this year. So again, not out of expectation for us, first quarter is generally lower. And those are some of the moving parts inside and inventory being a piece because we are excited about the recovery that's coming. We will, as you can see from our guidance, expect a step up in overall cash flow through the rest of the year. I'd say it's more bias towards the second-half of the year. And it's really predicated on two things, higher earnings relative to greater sales in the back half of the year, as we've talked about on our revenue guidance. And the second thing is we would expect to see some improvements in working capital, and bringing those inventories down for the rest of the year, as we worked down that inventory we built this year in anticipation of the market recovery. So hopefully that gives you some additional color on free cash flow.
Robbie Marcus:
Yeah, that's great. Thanks for the color.
Operator:
Our next question comes from Matt Taylor with UBS.
Matt Taylor:
Hi, thanks for taking the question. I wanted to ask you more about your recovery assumptions. I think you mentioned that expected Europe or EMEA to trail in recovery by a couple of quarters. Can you talk about what's informing that view? And when you mentioned, areas taking longer to go through the backlog, is that also Europe/EMEA?
Bryan Hanson:
Yeah. Just quickly maybe hit that backlog, recovery and Suky I'll turn it over to you. Yeah, Europe is typically one just based on the healthcare model there, that is a little slower to work through backlogs. The incentives just are not the same as you have in say, the U.S., for instance. So we would expect that to be a little slower in capturing the backlog. But interestingly enough, just because it's running behind probably will have one of the biggest backlogs as a percentage, right, help you look at the overall backlog versus the revenue in that region. And it will likely take the longest to work through just based on what we just said. But Suky, outside of that maybe you can provide more color on our thinking, on why we believe it's going to be lagging behind.
Suky Upadhyay:
Yeah, I think you summarized it well, Bryan as major is the vaccination rates are a bit slower than we had originally expected. Outside of that, outside of a EMEA, we also expect a few markets throughout Latin America, as well as the Asia Pacific to continue to lag, just based on so far the vaccination trend that we've been seeing. Hopefully, the vaccinations begin, the vaccines begin to roll out as robustly as they have in the U.S. globally. But until then, we expect COVID to continue to have a lingering impact on elective procedures.
Matt Taylor:
Great. And then, just wanted to ask on hips. You talked about the ROSA Hip launch later in the year, and that potentially driving you to your goal of above market performance. Can you talk about how sharp you expect the inflection to be and how quickly that can happen? Or any color on how much you think you can outgrow the market once you have that application?
Bryan Hanson:
Yeah, thanks. It's interesting, because I referenced that for sure, but actually, if you go back three or four quarters, we probably already in a share taking mode for hip. So just want to make sure that I give a complement to the team there. Having here complete has been a great launch. But just the portfolio that we had before once it gets fly out of the way, that team is really executing well. So I don't want to discount the fact that if you do look at the last three or four quarters, and you look at the other players in the market, we've done well versus the overall market. The confidence though in sustaining that goes up with a ROSA Hip application. So it's more of the confidence in being able to sustain what's already happened and potentially even buoy it further. And our goal here would be able to launch that in the back half. Again, the good news is we have a lot more experience with ROSA now, so our confidence level to go more to almost an immediate full launches there. So you're going to see a lot less time spent in limited launch for either partial or ROSA Hip. And we did -- we are going to a tailwind -- a significant tailwind for some time to come.
Matt Taylor:
Thank you.
Operator:
We'll take our next question from Richard Newitter with SVB Leerink.
Richard Newitter:
Thank you. Bryan, first question, I think I've heard you mentioned when you're talking about Persona-IQ, how excited you are about the platform there, and that you guys have a multi-year kind of vision strategically with Canary, including into hip and shoulder. My understanding was you were only exclusively for now partnered on knees. But did something change? And are you guys more exclusively focused now in other areas as well?
Bryan Hanson:
Yeah. We've done a lot of work with Bill and team over Canary. A great, great team over there, by the way, just really good people. And, yeah, we've solidified a very long-term relationship, basically, perpetual, with proprietary use of the technology in all areas that we play, all areas that we placed. So we are excited to be able to start to work on a very robust pipeline of technology. We've got to look at miniaturization, we've got to look at battery consumption, we've got to look at different form factors that would allow us to use the sensor in other implants. And that's something that we're going to be heavily concentrating on. And so, it's much broader than just knee [ph]. And the two organizations work really well together. And we're excited about the opportunity.
Richard Newitter:
Great, congratulations on that. And then just to follow-up on ROSA Hip. Thanks to the revenue contribution commentary. But just, I guess more philosophically, we've seen robotics uptake in hip your competitor just be slower, is a little bit different type of value proposition. I'm curious, one, are you noticing a mindset shift amongst the customer base with respect to how they're perceiving robotics and hips that would suggest runway for you, as you're launching are different from what maybe your competitor experienced earlier on in there launch of the hip? Or is there something that ROSA does, specifically with robotics that's different there?
Bryan Hanson:
I think, it's probably a little bit of both, potentially. I mean, if I think about it, the way I would think about this is in hip, you've got pretty good outcomes right now. It's different than -- you still have most people that get hip procedure that that ultimately feel like, they don't remember having it, because it functions pretty well. Whereas a knee is we always talk about really good 20% of patients that are a little frustrated with the outcome, because they don't get exactly what they expected. But on the hip side, because of that, most surgeons don't want to disrupt their flow, right. They don't want to take more time to do a procedure. And the key things that we do for ROSA perspective is to try to keep that pick -- that surgeon flow, that procedure flow, pretty consistent with what they're used to, and not as a result of that change the amount of time it takes to do a hip procedure. And I think that will be a very important differentiator here. We're not going to change the time needed to do this. A couple other things that will be different about this is it is a painless application of robotics to be a first that we'll see in hip. We don't have to place these pins basically drill into the bone of the leg, to be able to have the robot know where the body is in space. So that's going to be unique to us. The other thing that we're going to focus on here is the application out of the gate is going to be for direct anterior approach, which we know is the fastest growth subcategory hip right now. And it's a challenging procedure, because you don't have great visualization. And it's difficult as a result of that it’s a tough placement right. We're going to make both of those things easier through the ROSA application that we have. So we think the Avenir Complete implants, we think with this ROSA application, not taking more time to be able to do this the, painless application, and being able to allow people to see where they can see and place the cup where they need to place, it is going to be a big deal. That's what we're betting on.
Richard Newitter:
Thank you very much.
Bryan Hanson:
Sure.
Keri Mattox:
So Lauren, I think we have time for maybe one or two final questions.
Operator:
Thank you. Our next question comes from Steve Beuchaw with Wolfe Research.
Unidentified Analyst:
Good morning, guys. Liza Garcia [ph] for Steve Beuchaw. Just a quick one on Signature ONE planner, that was a meaningful sequential uptick. And so, I'm just wondering if you could talk about that, relative to your targets. And then also, if you could speak to ROSA Robotic placements in the quarter? And maybe I know, you said they were strong, but maybe if you could detail a little bit on the geographic trends there that you saw? Thank you.
Bryan Hanson:
Okay. So maybe I'll start quickly with that. We had a really strong quarter, again, as a reference pretty similar to what we saw in Q4 of last year. And I think, I want to be a little cautious there, because those are two exceptional quarters, and I feel very confident in our pipeline, but I wouldn't necessarily say that that becomes a new trend. And those are great, great quarters, for sure. And again, the pipeline is strong. And I would say that my confidence level is extremely high that the overall placements this year will definitely be more than last year. But I just don't want people to think that those quarters are going to be every quarter from here on out, even though the pipeline is pretty strong at this point. From a geographic mix standpoint, we continue to see really good traction OUS. So I've been very pleased with that, Asia Pacific in particular, but also Europe, Middle East and Africa. So it's been a good distribution around the world of robotic placements, which is one of the key things we wanted to concentrate on. So really strong quarter, the pipeline is very strong, Partial and ROSA Hip are going to help us with that, obviously. And that geographic distribution is a positive for us. On the Signature ONE planner, yeah, I mean, we're excited about it. I mean, until every single procedure uses pre-surgical planning, we're not finished. We truly do believe it is a better way to care for patients. If you don't know what you're getting into relative to the anatomy, how can you be as prepared as you should be to be able to do the procedure. So we want to make it easier for a surgeon to be fully prepared for that patient, knowing what they're going to deal with when they're in surgery. And pre-surgical planning allows that to happen. And the real benefit to us is that, number one, we feel the mission of the organization because we're going to do a better procedure, we truly believe that. And number two, we get that sidebar benefit of mix that more revenue per procedure, because if you know the anatomy challenging you're going to be dealing with, you're probably going to be able to get augments ahead of time and you're going to be able to ensure that you've got guides that you're going to need, and that's incremental spend, appropriate spend but incremental spend in the procedure. So that's the benefit for us. But just know that, no matter what the increases that we talked about on a quarterly basis, sequentially, until we get 100% penetration, we're absolutely not finished there.
Unidentified Analyst:
Great. Thanks so much.
Keri Mattox:
Thanks, Liza. And Lauren, I think we have time for one final question.
Operator:
Our final question comes from Pito Chickering with Deutsche Bank.
Pito Chickering:
Good morning, guys. And thanks for squeezing me in here. When I look at the strong first quarter of back into the implied EPS guidance for the rest of the year is generally in line as to your expectations. I believe that like you mentioned 2Q as a transient quarter. So are there any inventory pull forward or regional impact that can have a large impact on 2Q EPS estimates, in which case 2Q EPS comes down, the back half year goes up? Or has history generally modeled in the cadence of 2021 in the right way?
Suky Upadhyay:
Yeah. So, Pito thanks for the question. One of the comments I made earlier in my prepared remarks are about the seasonality and we're going to start to see that resembled war, pre-COVID cadence than what we saw in 2020. So, we would expect, again, Q2 to resemble that Q2, and Q4 tend to be our stronger quarters from a revenue perspective. These tend to see a little bit of seasonality and a dip in the third quarter. And we think that that's the same shaping for this year, perhaps not as pronounced as you would see in a undisturbed pre-COVID environment. But again, beginning to resemble what we experienced in 2019. So hopefully, that gives you a little bit more on shaping of our revenue and our P&L cadence as we move through the year.
Pito Chickering:
A quick follow-up question for you on ROSA. What's the breakdown between sales and leases in the first quarter? And I assume lease revenues are now located in the other revenues, how much lease revenue was there in the first quarter? Thanks so much.
Bryan Hanson:
Yeah. We don't want to provide specific breakdown of that next, but just know that we got multiple ways that you can place robotics and we track based on what the customer demand or need is. And we usually don't give any specific dollars, relative to what we can do with ROSA in a specific quarter. But again, I'll just reiterate the fact that, that it was a positive quarter for us, ROSA. And it was a big benefit. And again, the most important thing isn't really the either the quarter that these are placed, it's the tailwind that they create on a go forward basis, because now you've got an opportunity to be able to build revenue around those robotic systems. And what we do when we place these, you get a commitment to competitive conversions. But what we're finding is attracting this is that whatever we thought we were going to get, we actually get more. And a lot of times, it's not even in the knee business, it's in other businesses that just kind of come to it. It's almost like a halo effect that occurs in the product category. So, it's always important, we concentrate on obviously what happens in the quarter. But more than anything, it's the annuity value of this that occurs post that placement. And I'm just going to say, maybe with a quick close here, I know we get an alpha spec over to you care of it to close it out, but I just want to make sure that every focus a little bit of attention, I know that there's a ton of focus right now on trying to predict the exact moment that the pandemic is behind us and as a result of that the impact on 2021. And it's important, believe me, we're spending a lot of time on it too. But in reality, that's kind of the short-term thinking right now, in where I'm spending more of my time that organization is spending more of our time is, what does this look like post the pandemic, when it truly is fully behind us. And I kind of think of it in a few ways, number one, right out of the gate, the obvious thing is, we're going to have a backlog of patients that's kind of buoy the market growth for some period of time. I said before, I can't predict the amount of time it is, but there's clearly going to be at least a year or more of this backlog that when the pandemic has gone, it's going to be able to get this kind of extraordinary growth in the marketplace. And that's exciting, although not obviously sustainable beyond that. But there are other things that we're looking at now that truly give us a view that we could potentially reshape the curve of these large joint growth markets. And, big things for us kind of threefold. And the way I think about it, is there's no question is technology revolution is happening in orthopedics. We're going to help drive it, but others are doing it as well. And when that occurs, you're going to get a mixed benefit, you're going to see revenue premiums for every procedure, as this technology is adopted. If you think about that over a five year period of time, as you get higher adoption, that clearly has an opportunity to drive up the growth rates of the market. Now, we got to do it, until you actually get it done, it doesn't happen. But the fact is, we see a pathway through technology advancements to be able to bend the curve of these growth markets. The other thing that does too in my view or could do is that there's some hurdles associated with having this type of an ecosystem, this connected ecosystem. And that's going to create barriers to entry into the space where there really wasn't a lot before. And that gives you the byproduct benefit of longer-term contracts, deeper relationships with your customers, and probably better pricing stability. So those are something else that we're looking at with this technology. And I think the third one, I think, very important as we get better outcomes for patients and the confidence level goes up for these procedures, I truly do believe there are patients on the sidelines today that should be getting the procedure but are fearful of it. When they start to hear better outcomes, more technology, you may see some of those patients out of the funnel. Again, all these things are potential building blocks. As we think about the future of orthopedics, it can make the space much more attractive. We got to deliver on it. They're not guaranteed. We got to make sure that it happens. But that's where we're focusing our attention now to make those things a reality. So, I just want to leave you with those thoughts, because that's an exciting future, I believe for orthopedics. Keri, I'll turn it back to you.
Keri Mattox:
Thanks, Bryan. I'm sure we'll be talking to many of you today for calls and follow-up questions. If you do have them, please don't hesitate to reach out to the IR Team. We're always available over phone or email. Lauren, I'll turn it back over to you to close out.
Operator:
Thank you, again, for participating in today's conference call. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet Fourth Quarter 2020 Earnings Conference Call. [Operator Instructions]. As a reminder, this conference is being recorded today, February 5, 2021. Following today’s presentation, there will be a question-and-answer session. At this time, all participants are in a listen-only mode. [Operator Instructions]. I would now like to turn the conference over to Keri Mattox, Senior Vice President, Investor Relations and Chief Communications Officer. Please go ahead.
Keri Mattox :
Thank you, operator, and good morning, everyone. I hope you are all well and safe. Welcome to Zimmer Biomet's quarterly earnings conference call. Joining me virtually today are Bryan Hanson, our President and CEO; and CFO, Suky Upadhyay. Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by the forward-looking statements due to a variety of risks and uncertainties. Please note, we assume no obligation to update these forward-looking statements even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties, in addition to the inherent limitations of such forward-looking statements. Additionally, the discussions on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within our earnings release. As a note to all call participants, we provided updates via 2 press releases issued this morning, and we have also posted an investor presentation to our website, zimmerbiomet.com. With that, I'll now turn the call over to Bryan. Bryan?
Bryan Hanson :
All right. Great. Thanks, Keri. And also I want to say just thanks to everyone for joining us on the call here this morning. As you saw from our announcements earlier today, we clearly have a few updates that we want to fill you in on and I'm looking forward to a very productive call this morning. Just given the backdrop of COVID, let me just start by saying that I certainly hope that all of you are doing well and staying safe. And continuing to, as much as it's frustrating, I'm sure by now, continuing to social distance and wear your masks. I think, at this point, we're all pretty good at it. So let's make sure that we continue to do it. And to all of the ZB team members joining the call this morning and who are listening at a later time, I just want to let you know I'm thinking about you as well. I just want to say thanks. Thanks for everything that you do and have done and will do actually to continue to follow our protocols, to keep yourself safe, obviously, but also our teammates safe. And as a result of that, continue to deliver for our customers and our patients and move our mission forward. And I just continue to be very proud of everything this team has accomplished against a significantly challenging backdrop in 2020. So, I'm proud of you, I'm glad to see what you've been able to do, and I'm looking forward to what you're going to do in 2021. And here we are, right? We're in 2021. And there's going to be challenges and we've seen already early on in 2021, but I'm confident that we're ready to deal with the challenges as we do, and I'm pretty confident that we're going to see some real opportunities for 2021 as well. And there's just a lot of updates that I want to share with you today, but I'm going to keep my comments to a minimum, if possible. I really want to make sure that we have time for Suky to get into a little more detail on Q4 and then ultimately say how that's going to translate into 2021. Now we're not going to give too many specifics on 2021, but he'll give you some color on what we're seeing from Q4 and again, the impact we think that's going to have on 2021. And I want to make sure that we leave time for questions as well, okay, so for today, I'm just going to kind of keep it to 3 main topics. The first is really how we're continuing to navigate COVID-19 and to continue inside of that to ensure that we're executing against our strategy. The second one is really going to talk about the ongoing transformation of the company. We really are making sure that we're moving forward with active portfolio management. And obviously, we're taking the next steps there with the planned spin-off of our Spine and Dental business. So, we'll talk a bit about that, and then third, I want to make sure that we, again, touch upon our long-term growth strategy and how it positions us to drive growth, obviously as a company, but also value for you and value for us. And so, let's start again, navigating the challenges and executing here in the short term. There's just no doubt that COVID, unfortunately, remains a challenge. Coming out of Q4, we're seeing the pandemic pressure and the surges continue, and frankly worsen across pretty much all of our regions and markets. There's clearly more lockdown measures that we're seeing throughout Europe, Middle East, and Africa, to a far lesser extent, but still impacting Asia Pacific as well. And certainly, in the Americas, we're all seeing it in the U.S. May be different by state, but we're clearly seeing increased pressure as a result of surges in the pandemic. So, all of that is kind of the backdrop that we saw coming out of Q4. Unfortunately, this pressure in the corresponding decline in elective procedures grew throughout Q4 and actually was worse at the end of December. And at this point, we expect that increase in pressure will continue throughout Q1, at least and will impact all 3 of our regions. As a matter of fact, we're actually seeing this probably increase in pressure coming out of Q4. So, we would expect Q1 to be a little more challenging than even what we saw in Q4. But even given that backdrop, I'd say that I'm optimistic. Sounds crazy to just say what I said, but say that I'm also optimistic, but [indiscernible] the approved vaccines. We're currently rolling those out around the world. We do believe the vaccines are going to change the COVID-19 dynamic, and we're going to see positive impact as a result of it. As soon as we start to see the surges stop, we see the impact of COVID end. And we're confident that the recovery is going to mean that the normal patient flow is going to start again, and we're going to have the pull-through effect of a sizable patient backlog that's been created over the past number of quarters. We expect that when that recovery occurs, we're going to see a period of what I would define as normal market growth augmented by deferred procedures that will be coming in as well. And we're going to be ready for that. And we're excited about that. So as much as it's going to be a little rocky in the short-term and potentially more challenging than what we saw in the fourth quarter, we see a light at the end of the tunnel, and that's a good thing. The big question is when? When is that going to happen? We know the vaccine is going to have the impact. The big question is when. And that's certainly going to be the key variable we're going to be looking at as we try to predict where 2021 is going to look like. So while I would just say, against this backdrop of COVID, what is clear to us is we can't control when the vaccines allow the surges to stop, but what we can control inside of that is how we execute our strategy. And I have confidence we're going to continue to move forward. Our core business is strong. Our execution is on point. I would just say momentum around our key commercial launches and programs continues to be strong. And I would say that overall, our commercial confidence is better than it has ever been. So let's give a few examples of this. I can say it all day long, but once we talk about it and actually, it reflects in the numbers, who cares. So let's first start with ROSA Knee. Obviously, this is something that everyone's going to be paying attention to. Certainly, I am. And I know we said we're going to hit between 200 to 300 cumulative placements by the end of 2020. Obviously, you know that we are in that range as of Q3. So I'm happy to report that, not only did we achieve that goal, we achieved the high end of that goal. And I would tell you that the momentum is strong coming into 2021. Q4 was actually our strongest quarter as of the date of launch of ROSA Knee. So we had some pretty strong quarters in the past, Q4 was our best, and we were on the high end of the goal that we set for the year. And as I've said before, with some of the new launches that we have coming, specifically associated with the knee, I feel pretty confident that 2021 is going to continue to show that kind of resilience and strength for ROSA Knee. On the Persona Revision side, again, this product continues to be very successful for us. We now show that in Q4, we actually had the strongest quarter-over-quarter growth that we've seen since launch. We did realize our 2020 expectations of $100 million in gross revenue and almost $40 million in net of cannibalization revenue during the year. And I would just tell you that that's just the beginning because Persona Revision serves as a really compelling tip of the spear product for our commercial team. Once we get Persona Revision in, we've got an opportunity to hunt for the typical primary knee as well. So we're very excited about that launch, and it continues to be strong. On the hip side, Avenir Complete continues to be a strong one for us. Even in the pandemic, it continues to beat our expectations. And if I just look at Q4 specifically, we grew about 30% over Q3, again, even with the increased pressures of the pandemic in Q4. So very excited with what we're able to do with Avenir Complete, and we expect big things to continue with this product throughout 2021. And as you obviously know, we also expect at the end of 2021 to launch the ROSA Hip which, again, gives us a lot of confidence in the hip category for our business. And then finally, for Signature ONE Planner, we demonstrated, again, strong sequential growth with registrations up nearly 25% in Q4 over Q3, and we expect utilization to continue to expand significantly in 2021 with really a goal of having more than 50% of our shoulder procedures using presurgical planning. And that's important for a lot of reasons. Remember, the presurgical planning creates stickiness with the customer. But it also enhances our ability to get more guides and to augment using the procedure, which can really take up the ASP for that procedure. So again, exciting stuff with Signature ONE Planner as well. And so all in, we continue to execute -- we continue to execute as a team. The way we're showing up every day, the way we're showing up in the market, frankly, versus our peers, gives me confidence in our business as does our continued innovation and our product launches. But we're going to see more this year, some pretty pivotal innovation that we're going to see this year. As I mentioned before, we're going to see what ROSA Partial Knee, we're going to see ROSA Hip. And we're also going to see the first smart implant, Persona-IQ, launched this year. So definitely exciting for us from an innovation standpoint in 2021. And yes, that leads me to really my second topic this morning. We continue the transformation of ZB. That's been the goal since I got here. You've heard me talk about our 3 phases of transformation. First was the hearts and minds and the execution challenges that we had in the very beginning. That's what we talked about a lot in the beginning. The second phase of this was really doing a more robust, longer-term strategy, making sure that we brought innovation to the market and getting our execution straight. We're clearly well into that phase. And third is our portfolio transformation. And that's the goal of active portfolio management to change the complexion of the organization, so that we can have better goal of sustaining the mid-single-digit growth. And I'm proud to say that we're squarely positioned in phase 3 now as well. And as you've seen by our recent announcement, we're going to continue to move this forward. We have the portfolio management strategy and the process in place and have built a pretty strong capability to move us forward in this area. Late last year, we executed a number of smaller but still important M&A deals to fill portfolio gaps and to better position us in higher growth areas that we do believe we have a right to win in. And just this morning, we announced our intent to spin-off our Spine and Dental businesses. Ultimately creating, we believe, 2 independent, publicly traded companies, both Zimmer Biomet and the new company called NewCo that are going to be better positioned, separate. I truly believe, by separating out these businesses, we're going to create 2 stronger companies. 2 companies that are going to be better positioned to meet customer needs and improve patient lives, and ultimately, and very importantly, deliver greater value to you, our shareholders. And let me give you a bit more detail on why we believe this is an opportunity for value creation and really why we think it delivers value for both the ZB and NewCo. First of all, the transaction increases our management focus and resource prioritization. We truly do believe for both companies. We think about NewCo, and we think it's going to thrive as an independent company with prioritized capital allocation to pursue strategies and growth opportunities and through the investments inside of Spine and Dental that has not been a focus for ZB. It will absolutely be a focus for NewCo. And for Zimmer Biomet, the transaction is an important next step in our transition into a more streamlined company with sharper focus in greater and more optimized resource allocation towards innovation in those core businesses that we are committed to, that are profitable for us, where we see attractive markets with a right to win in those markets and be market leaders. And really, the second thing is it's going to drive increased growth and efficiency for both companies. We really do believe that. Simply put, we expect that these 2 companies, with their simplified operating models and just reduced complexity and increased focus, we'll be able to grow revenue, margin and earnings per share faster than they would if we remain combined as one company. And Suky is going to talk more about the specific financial impact that we expect in just a few minutes, but just note, it's positive for both organizations, financially speaking, as we separate the organizations. And third, it's going to enhance value creation for our patients, our providers and all of our key stakeholders, including our own team members. This is the next step in ZB's transformation, and it underscores our commitment to ensuring long-term priorities remain aligned with shareholders' best interest. It's going drive the business forward to meet customer needs and advance our mission to alleviate pain and improve the quality of life of people around the world. We think we can do it better as 2 separate organizations. Okay. So that's the backdrop of the spin. And today, obviously, it's just day 1 in terms of announcements around this process. You can absolutely expect that we're going to continue to provide updates as we move forward, as NewCo takes shape and as we move towards the transaction close, which we're currently expecting to be around mid-2022. Okay. So we're confident in the steps we're taking and our ability to keep executing and in our overall ZB strategy. And that brings me really to the third and really the final topic that I have for these remarks, and it's our plan to drive long-term growth. And ultimately, as a result of that, deliver increased value for you. And to do that, we remain fully committed and confident in ZB's long-term growth and margin expansion expectations. In fact, the spin-off transaction that we're going to do over the next year serves to de-risk, if not accelerate, our path to that 4% to 5% growth rate we've talked about and our 30% operating margin profile by the end of 2023. And to get there, to be able to deliver on both of those, we're going to have to be committed to our priority growth areas, and we've talked about these in the past, but I'm going to remind you of them again. The key area of concentration for us would be knees, hips and S.E.T. If we think about knees first and foremost, we need to be able to grow above market rates here. And we're going to continue to focus on the fastest growth submarkets of knees. For us, that's going to be robotics, data and informatics, cementless and revision. We feel we have plenty of innovation and momentum here to continue to grow sustainably above market rates in knee. From a hip perspective, it's a little less ambitious in the beginning. We just said that we need to grow at market in the short-term, with the idea that over the long-term, particularly after ROSA Hip is launched, that we would grow above market in hip as well. And I can tell you based on our performance so far, the ROSA Hip application being launched later in 2021 and the Avenir Complete momentum that we have, we feel confident we're going to be able to do that as well. And as far as that goes, we just want to grow at market, if not the higher end of market. And to do that, we're going to focus on the most attractive sub-element of S.E.T for us and that's, for us, again, going to be sports, medicine and extremities. Those are key areas of concentration for us that we're going to invest internally. We're going to look for external ways to build scale, and we're going to build commercial infrastructure as well, right? It's only closed by saying that I continue to be more confident about ZB's future than ever. I know I say that a lot recently, but I really do feel the momentum right now. I truly believe that we are well positioned for success and that our strategy is absolutely working. And our transformation is well underway. And our proven ability to rise to challenges and face adversity, I think has prepared us well for navigating the current environment. And really, for that matter, any environment in front of us. And I just want to, again, say thanks to the entire ZB team in your focus on our mission, our strategy and how we show up and execute every day is unmatched. It's what makes ZB and what makes me confident that we're going to continue to deliver. So with that, I'm going to turn the call over to Suky for more financial details of the quarter and also looking forward. Okay. Suky?
Suky Upadhyay:
Thanks, and good morning, everyone. Before jumping into the details, I'd like to summarize the quarter as one where we made significant progress across a number of strategic and operational fronts, all in the backdrop of heightened market pressure. While revenue and profitability were challenged due to the pandemic, we executed extremely well against the things we can control, positioning ourselves to win through eventual market recovery and beyond. Now for this morning's call, I'm going to focus on 2 topics. First, our Q4 results, including commentary on the COVID impact and what we're seeing so far in Q1; and second, how ZB is positioned for long-term growth, specifically, how we believe the spin-off transaction we announced this morning is expected to impact us post execution. Moving forward, unless otherwise noted, revenue and P&L commentary will be on a constant currency or adjusted basis. Net sales in the fourth quarter were $2.085 billion, a reported decrease of 1.9% and a constant currency decrease of 3.7% versus 2019. But we did not experience any material day rate differences in our year-over-year comparisons. Our consolidated regional results were in line with expectations despite deepening pandemic pressure on global elective procedures as we exited the year. While the market softened through the quarter, execution remained strong across all regions. Beginning with Asia Pacific, the region grew 2% versus Q4 2019 with growth across all 3 of our largest markets of Japan, China and Australia, New Zealand. While COVID pressure on elective procedures increased towards the end of the quarter, the impact is less pronounced than what we are seeing in EMEA and the Americas. We are excited about the uptake we're seeing in ROSA in the region and with the solid performance across our knee and hip businesses. As expected, the EMEA region was hardest hit by COVID-19, decreasing 17.5% versus 2019, with all sub-regions in decline. Surges in the virus leading to policy actions and government lockdowns negatively impacted elective procedures across the region. Lastly, the Americas region was about flat, decreasing 0.3% compared to 2019, driven by continued COVID headwinds in Latin America, in tandem with a softening U.S. market. The U.S. was flat despite increased pressure on elective procedures. Performance was buoyed by continued strong demand for recent innovative product introductions, strong execution by our commercial organization and some favorable impact related to the order timing and year-end purchases, as some accounts increased their buying patterns to utilize remaining 2020 budgets. Turning to our business performance for Q4. The global knee business declined 4.8%, negatively impacted by the ongoing pressures in EMEA. However, the U.S. knee business continued to grow, increasing 1.8%, and Asia Pacific knee business returned to growth increasing 2.9%. Overall, execution was strong with continued momentum for Persona and ROSA Knee. Our global hip business decreased 3.4%, again, driven by declines in EMEA. Both U.S. hips and APAC hips continued their growth trends, increasing 1.4% and 1.3%, respectively. Sports, extremity and trauma sales declined 3.3%. Dental, Spine and CMFT continued to deliver better execution, increasing 0.8%. And finally, our other category was down 9.3%. Moving to the P&L. We reported GAAP diluted earnings per share of $1.59 and adjusted diluted earnings per share of $2.11. Additional details on our GAAP results can be viewed in our press release issued this morning. On an adjusted basis, with revenue down 3.7%, EPS was down about 10%, driven by a lower operating margin and a higher share count, which more than offset the favorable tax rate in the quarter. Lower adjusted operating margin was driven by lower revenue and an expected year-over-year decline in gross margins. Adjusted gross margin was 71.3%, sequentially better than Q3 but lower than Q4 2019. Versus the prior year, favorable geographic mix was more than offset by lower volumes, ongoing pricing pressure and the impact from prior period deferred costs. OpEx was down versus the prior year as we implemented several cost containment initiatives as part of our response to the pandemic, in addition to the realization of our transformation programs that were ultimately reinvested back into R&D and commercial infrastructure to help drive consistent above-market growth in priority areas. Based on our performance versus market over the recent quarters, our reinvestment of efficiency savings is translating into strong returns. The Q4 adjusted tax rate of 15% was better than the previous year due to geographic mix of income and certain discrete benefits in the quarter related to recent audit settlements. Turning to cash and liquidity in the quarter. Free cash flow totaled $329 million, higher than the same period in 2019, driven by better working capital and lower capital expenditures. And we utilized better-than-expected cash flow to pay down $250 million of debt ahead of schedule, ending the year with cash and cash equivalents of approximately $800 million. Now moving to 2021. Due to the ongoing uncertainty related to COVID-19 and its impact on elective procedures, we will not be providing full year financial guidance at this time. We recognize that this is challenging for you as you build your '21 models. However, we will reserve financial guidance until we have more certainty around the outlook of elective procedures relative to COVID surges, and related vaccine adoption. We strive to be credible and transparent. And to that end, I will provide additional quarterly details and broader full year shaping as an interim measure. So far through January, we've seen COVID pressure continuing to intensify from the end of December. Based on what we've seen so far in the quarter and in tandem with our latest estimates for procedure cadence, we project that Q1 revenue will be down in the low single-digit to mid-single-digit percentage range versus Q1 2020. Now we have optimism and confidence that we'll see a positive vaccine impact on elective procedures this year. And once we do, we expect elective procedure volumes to return to pre-pandemic levels and the sizable patient backlog to serve as a tailwind to underlying market growth. As we turn to the P&L, we expect that the impact of COVID-19 on sales volume will put pressure on adjusted operating margins and earnings leverage until we return to consistent pre-COVID revenue levels and growth rates, as I just discussed. Despite this near-term pressure, our confidence in the market recovery and the longer-term financial profile of the company is driving continued investment into priority areas of the business. We expect that adjusted gross margin will stabilize in 2021, with quarterly margin levels broadly in line with what we saw in the back half of 2020. We could see some fluctuation from quarter-to-quarter depending on a number of variables, including volumes, price, foreign currency, mix and other drivers that can change results over time. Regarding operating expenses. Sequentially versus the fourth quarter of 2020, we expect non-commission spending in Q1 to be modestly lower with increases in future quarters' OpEx investments as the impact of the pandemic abates. We expect interest expense to increase in the mid-single-digit versus 2020, as the benefit from lower debt balances is more than offset by the renewal of net investment hedge positions. Our tax rate is expected to be modestly higher than the full year 2020 rate and could fluctuate over the year as a result of variability in geographic mix of income due to the pandemic. Also, we are not projecting any material U.S. corporate tax reform to be implemented in 2021. We project that the full year share count in 2021 will continue to increase modestly versus Q4 2020, and we are not planning for any share buybacks in the year. And in terms of capital allocation, we remain committed to maintaining our investment-grade rating and are planning to pay down an additional $500 million of debt in 2021. Now let's turn to today's announcement related to our intent to spin the Spine and Dental businesses into an independent publicly traded company. The transaction will be structures of tax redistribution of newly issued NewCo shares to ZB shareholders. As Bryan mentioned, we believe that this tax-efficient transaction, which is expected to close in mid-2022, subject to certain conditions, will drive greater focus for each company with an enhanced prioritization of capital allocation, while accelerating growth and providing the platform for greater shareholder value. In terms of the NewCo financial profile, 2019 and 2020 pro forma revenues totaled approximately $1.022 billion and $897 million, respectively, and is supported by a diversified geographic base with real opportunities for enhanced growth and margin expansion. We expect NewCo to have a financial profile generally in line with its peer group and a capital structure supportive of innovation and investment over time. Importantly, the transaction will empower NewCo to pursue a more focused investment and execution strategy. ZB delivered 2019 and 2020 pro forma revenue of $6.96 billion and $6.128 billion, respectively. For post-spin ZB, the transaction is expected to deliver an improved growth profile with accretion to our revenue growth of approximately 50 basis points over the course of our 5-year strategic planning period. We also expect that it will expand our adjusted EBITDA and operating margins on a pro forma basis by approximately 125 basis points. With that, you should have even greater confidence in our operating margin expansion goals. We remain committed to at least 30% adjusted operating margins by the end of 2023. And with this transaction, we have the opportunity to accelerate the timing of that goal. However, we will continue to balance margin acceleration against investment opportunities to accelerate durable top-line growth. Ultimately, this transaction provides greater optionality to invest more in the business, while delivering a leading margin profile, and that's an incredibly powerful lever. And in terms of capital structure, post spin, we will prioritize proceeds towards debt pay down to maintain our investment-grade rating. We're truly excited about this transformational opportunity to increase value for our investors, and we'll continue to provide more details as execution of the spin progresses. To summarize, while the pandemic continued to pressure our growth and earnings profile in the quarter, we made substantial progress on many fronts, including very strong performance versus the market; progress on our efficiency programs that enabled increased investment for growth; free cash flow generation that was ahead of revenue growth; strengthening of our balance sheet through early pay down of debt; integrating our strategic and accretive tuck-in M&A deals; and positioning ourselves to execute the spin-off of our Spine and Dental business as a platform for greater value. I'm truly proud of what the ZB team accomplished in the quarter and throughout 2020. With that, I'll turn the call back over to Keri.
Keri Mattox :
Thanks, Suky. Before we start the Q&A session, a reminder to please limit yourselves to a single question and one follow-up, so that we can get through as many questions as possible during the call. With that, operator, may we have the first question please.
Operator:
[Operator Instructions] Our first question comes from Steven Lichtman with Oppenheimer & Company.
Steven Lichtman:
Bryan, as you continue in phase 3, obviously accelerated with today's announcement, I was wondering if you could provide your latest thoughts on capital allocation. Are you still targeting tuck-ins, larger deals? Any color would be helpful. And I have a follow-up on COVID.
Bryan Hanson:
Okay. Yes. I'll just briefly answer your first question, and then I'll pass it over to Suky. But yes, our capital allocation strategy remains the same. We do want to look at tuck-in acquisitions that we think would have low dis-synergy risk and we have a right to win in the space. And that's what we're going to continue to do. This does not change that. And Suky, you want to give maybe a little more color just overall -- on the overall capital allocation strategy?
Suky Upadhyay:
Yes, sure. So we made good progress even in the backdrop of the pandemic in 2020. We're going to continue to make progress in strengthening our balance sheet and creating firepower moving forward. As I said in my earlier remarks, we expect to pay down about $500 million of debt -- of maturing debt this year. And as cash flows improve, as the virus abates throughout 2021, that will increase and expand our opportunity, firepower opportunity for continued tuck-in M&A. So again, consistent with how we talked about previously, first priority is to maintain investment grade, pay down debt, delever. And our second priority from a capital allocation standpoint is to continue to grow that topline and bottom-line through accretive strategic tuck-in M&A, and this now gives us even greater focus through our spin transaction.
Steven Lichtman :
Great. And then just on COVID, where do you think the size of deferred procedures is? I know we've talked about in the past, I know it's a tough number to tee that, obviously. But any comments there would be great as we hopefully see end market conditions improve as the year goes on?
Bryan Hanson :
Yes. It's a fantastic question truthfully and one that we track quite a bit and try to estimate. I would just say that without being able to be a fine point to it, it's hundreds of millions of dollars is the way that we view it. And that's what gets us pretty excited about the fact that the end of the pandemic, and our view is on the horizon. And once that occurs, we've got a heck of a backlog that we need to work through. Now the timing of when you work through it, it's based on capacity, capabilities in different markets and those types of things, but we feel it's very sizable, and we're excited to start working through it.
Operator:
And we'll take our next question from David Lewis with Morgan Stanley.
David Lewis :
Just 2 for me, and I'll start strategically on the spin, Bryan. A lot of times in spins, we create a lot of value through multiple arbitrage between the 2 assets. We even finished our math there. My sense is the multiple spreads won't be that wide here. So the real value creation for Zimmer is sort of to execute your goals or grow faster. So, when you say 50 bps of growth, Bryan, does this get you to 4% to 5% growth faster or are we talking about it's just going to get you to a higher end or higher structural growth rate at some point towards the end of the LRP? And then I have a quick follow-up…
Bryan Hanson :
Yes, yes. So for us, when we just think about growth rate, we're kind of sticking to that 4% to 5% that we've been talking about. But what we should look at here is that you should have greater confidence, obviously in our ability to do that and potentially be on the higher end of that range. And so that is a key focus for us. And really the significant value for us is that ability to focus. Remember, we talked before about getting to 4% to 5%. We had a number of variables associated with it. One of those variables, even though we didn't have the same level of investment in these businesses, was that they had to grow at least at the lower end of the market. And over time, if you're not investing appropriately in businesses, there's risk in that. So, we've eliminated that risk as we spin these out, and we've unlocked value for SpinCo because ultimately -- or NewCo because ultimately, they're going to invest more intently in those businesses. So, it provides value in both ways, but go ahead on your second question there.
David Lewis :
Sure. And sorry, Bryan, can we think about our confidence which suggests that maybe 4% to 5% growth is possible in the next 2 years? Is it there any faster? And then I'll ask my other question for Suky just real quick. Suky, there’s a lot of focus this call on the USD number. Can you just give us any sense as it relates to the USD number, what was the impact of those strategic deals or bulk purchase deals on the fourth quarter and how does the ROSA contribution in the fourth quarter on a revenue basis look relative to the third quarter?
Bryan Hanson :
Suky you could talk, you’re on mute.
Suky Upadhyay :
Yes, thank you, Bryan. So thanks for the question, David. On your first question relative to the year-end and the U.S. number, it's not uncommon at the end of any quarter, especially at the end of the year-end, to see higher sales and some potential timing favorability or headwinds for that matter. In this quarter, we actually saw some incremental uptake in our U.S. business. Again, probably not different than what many others saw across our sector as many accounts were utilizing their year-end budgets to bring in some product. For us, we look at it, it was a modest benefit on the total company. It was in the low-single digits. But again, it was something that was above our normal trend, so we wanted to make sure we called it out. And again, any impact that, that might have into 2021 is reflected in those Q1 estimates that I've already provided. So overall, still a very, very strong quarter for the company versus market, both in knee and hip. Your second question relative to ROSA. We did see a shift in the fourth quarter, especially with those expanded hospital budgets or remaining budgets, I should say, more dollar sales on installments than we've previously seen in Q2 and Q3. But year-over-year, Q4 last year to this year, it was not a major material headwind or tailwind on our overall growth numbers.
Keri Mattox:
Operator, can we have the next question please.
Operator:
We'll take our next question from Larry Keusch with Raymond James.
Larry Keusch:
Just wanted to first come back to the spin-off here. I guess, what I'm really curious about is why is now the right time for this spin-off? And along with that why a spin versus the sale? And then I'll come back to the second question.
Bryan Hanson :
Yes. So the timing of it is -- it fits right into the phases of where we look at transforming the business. For us, it was sequential. We wanted to make sure that phase 1 in our transformation was in great shape, and it is. Phase 2 would need to be well underway before we want to take something like this on. And I think based on our performance over the last few quarters versus our competitors, it's pretty clear that Phase 2 is working quite well. And now's the time. It's time for active portfolio management. And in a time when we don't have as much capital to work with, this is clearly one of the most significant ways that we can impact and influence the portfolio in a positive way for both companies, I do believe that. So that's the why now. And we're excited about it. We truly are. We're excited about it for our organization, NewCo -- and we're excited about it for NewCo. And we'll be in it together for the next year, 1.5 years and even post that. So that's the margin -- the line now. And we've looked at multiple ways to drive value with these businesses. Just know that this isn't the only option that we've looked at. And just given the number of options on the table, we felt that this was the most significant way that we could drive value for our shareholders and our businesses and our team members. So that's the reason for the spin.
Larry Keusch :
Okay. Very good. And then, Bryan, look, you guys seem to be increasingly well positioned in creating sort of this digital ecosystem in orthopedics. If I think about it, you've got a surgical planning, you've got robotics, you've got mymobility, you've got Persona-IQ. So maybe just talk about how you see the product offering evolving at Zimmer and how the ecosystem can help improve outcomes? And what are you thinking about sort of reimbursement for Persona-IQ from both the implant and the remote monitoring aspect of it?
Bryan Hanson :
Yes. So no, I won't get into specifics on reimbursement for Persona-IQ, but we definitely see it as a very important piece of the puzzle when we think about the ecosystem that you're referencing. And I would just say that we're taking it very seriously when we look at ecosystem versus just the typical implant. We've had a significant shift in our research and development dollars towards robotic storage, data infomatics to build that ecosystem that's going to be meaningful for patients and for our customers alike. And I got to say, there's a lot of excitement around that in our organization, a lot of excitement from our customer base as well. And the competency that we've built over the last few years in this area is, in my opinion, second to none. And where we don't have the competency, we've been working with external partners that have pretty significant names like Apple, and you're going to hear more about those coming up as well. So we feel really good about where we are today. And we feel, in my opinion, anyway, that these ecosystems to be able to capture data before, during and after procedure are going to be a significant benefit for patient outcomes. And ultimately, at some point, when we pick up enough data and have the data like available to us, be able to have predictive analytics to be able to make better pure decisions before the surgery occurs. And that's really the intent. So we're very excited about it. We've shifted dramatically research and development in this area, and we feel we're ahead right now versus our competitors.
Operator:
Our next question comes from Larry Biegelsen with Wells Fargo.
Larry Biegelsen :
Just 2 financial questions for me, probably both for Suky. So Suky, the margins of the Spine and Dental businesses, how do they compare to the new or current Zimmer? You talked about them being similar to peers, but there are a lot of different peers out there. Can you give us a little bit more color on the margins of those businesses, please? And I have one follow-up.
Suky Upadhyay :
Sure. Good morning, Larry. So the first thing I would say is we’ve provide some color on the pro forma accretion impact on our RemainCo EBITDA and operating margins, which should give you a good initial view as to what the NewCo margins could look like. Just stepping back, overall, both those businesses are, Spine, Dental and our bone healing business, have a gross margin profile that's a little bit below the overall company average. I would say bone healing is actually a little bit above the company average. But really, it comes down to the cost to serve where the spending levels in both those businesses are much higher than the company average, which overall drives the operating margin for both Spine and Dental lower than where ZB HoldCo is from a standalone basis. So as we think about margin opportunity going forward in both those businesses, we do think that there's opportunity to enhance margins. One will come through, we believe, a real opportunity to accelerate top-line growth, which will bring some operating leverage to the business. But there's also opportunity for mix shift and potential efficiency within the existing cost structure. So hopefully, that gives you a little bit more color on how to think about margins in those businesses going forward.
Larry Biegelsen:
That's helpful. And then on 2021, you gave some helpful color on Q1 revenue growth, Suky. Maybe you could talk about sales growth cadence through the year, just any reaction to consensus, which assumes about 2% growth over 2019. I know you don't have guidance out there, but just directionally -- and operating margins. In the past, I think you said they could come close to 2019 but maybe lag a bit. How should we be thinking about that for full year 2021?
Suky Upadhyay:
Yes. Yes, absolutely. So first, on revenue, why we're not providing guidance is because there are a number of variables that are just really difficult to predict at this time with any level of credibility or confidence. The first being where is the trough in this most recent surge that we're seeing. January, February, where does it land in Q1? What does that uptake look like post adoption of vaccine. And then when do you ultimately return to normalized market growth and potential tailwind from the deferred procedures. So we're running a number of scenarios. There are some scenarios where absolutely we could see a path to growth versus 2019. But again, those variables are, at this point, just too uncertain. But clearly, I think just stepping back, once we do have adoption -- wide adoption of that vaccine, which we believe will have at some point in 2021, we think that there's a real opportunity for some strong growth, again, once we return to normalized market and are augmented by that tailwind. But it's just too difficult to say what our cadence looks like at this time. Regarding margins, you're absolutely right. As the margins or revenue continues to improve throughout the year, which we believe it will, once we have good uptake with the vaccine, the margins should follow. There may be a slight lag, consistent with how we've talked about things before as we catch up on certain investments. But make no mistake, they will expand, and we do see the opportunity for significant margin expansion over time as we normalize our revenue uptake.
Operator:
Our next question comes from Amit Hazan with Goldman Sachs.
Amit Hazan :
I wanted to start on the U.S. market for knees and hips. And obviously, with the dollars, there's a lot of noise as you mentioned. So just from an underlying basis, I'm wondering what you think about market share -- what you think what happened to market share in the fourth quarter for you in both knees and hips in the U.S. from a volume perspective?
Bryan Hanson :
Yes. Yes. So what I would say is, I try not to look at any specific quarter and draw too much of a conclusion. I would now -- saying that I'd much rather have what we just saw in the fourth quarter, where we're significantly above-market growth that always feels good. But instead, more look at a trend. And if I just go back, let's call it, 3 quarters, that gives you more of a sense of how we're doing versus market. And if I think about U.S., which is probably the cleanest way to look at this because there's a lot of noise in the mix and everything else that people may have outside of the U.S., but we just look at U.S. and we're somewhere in the neighborhood, just think about large joints, 500 to 600 basis points over the last 3 quarters above market, above our key competitors. Knees is a little better than hips, but we're seeing outperformance in both. Knees probably more 600 basis points to 700 basis points and hips, more like 500 basis points to 600 basis points better. So that's what I look at. Not a single quarter, but a combination of quarters and where we're seeing that trend. And by the way, I fully expect us to continue that trend. And I talked about the innovation that is going to be pretty pivotal this year in both hips and knees with the current momentum that we already have, with the commercial prowess that we have as an organization, and that innovation is still yet to come, and our confidence level is pretty high.
Amit Hazan :
And I just wanted a follow-up -- focus on R&D. And as we look at just the absolute number this year, I was on that you haven't spent this little on R&D in several years. It's down 15% for the year. And that kind of separates you from other companies in medtech, and like that medtech and clinical. I'm wondering if you can give some color to where you've made the cuts, how you're prioritizing that budget, and how that impacts your future product cadence?
Bryan Hanson :
Would I like too much to run a business? It's, first and foremost, always assessing how are you spending research and development dollars and then making mix shift spend to make sure that you're spending it wisely. And so that's why you saw -- you're not seeing research and development increase. You saw some slight compression there. But it really was just to get straight on what are we going to spend our dollars on. And we killed a lot of projects that just didn't have returns that we expected. And that's the cleanup, if you will. What you're going to see from here, though, is an increase, for sure, in research and development. I always want to make sure that we're spending money wisely before we say whether we're spending enough or too little or do we need to spend more. We have a real good deal now for what we should be spending money on, that we're spending money in a disciplined fashion, and we have a lot of things in the bulk in now that we want to turn on. So as we look forward, you should expect to see increased spend in research and development, but increased spend in a very disciplined way.
Operator:
Our next question comes from Bob Hopkins with Bank of America.
Bob Hopkins:
I'll just state my 2 questions upfront in the interest of time. So the first one is just to come back to something people have been asking about already, but I was wondering if we could get just a little bit of a better sense for the impact of the bulk orders that you're calling out on Q4, specifically on U.S. hips and U.S. knees. And again, the reason I ask is that your hip and knee growth in the U.S. is so materially above what we're seeing from peers. And the gap was just very, very wide this quarter. So any sense as to the quantification on U.S. hips and U.S. knees in those bulk orders would be great? And then on the second question, which is on the spin announcement, Bryan. I mean, I don't think it's unfair to say that Spine and Dental are 2 relatively subscale businesses with not a lot of synergies between them. So I guess my question is, why not sell them to the folks with scale? It just seems like that will be a lot cleaner. So would love your take on that.
Bryan Hanson :
Yes. So first of all, on the quarter itself, again, we feel great about our quarter performance. And I would say that when you're looking at this year, in COVID, in particular, there was a lot of money that folks had to spend, and we always see in the fourth quarter, we've seen purchases that occur. We see it every quarter, but fourth quarter, in particular. So it's not abnormal to see as Suky referenced before. If I was going to try to put a number to it, I'd say maybe in the 200 basis points to 300 basis points of benefit that we saw, if you're thinking about large joints. So it was important for us in a normal quarter given this quarter differential between us and competitors, not as material. And I would be surprised, quite frankly, if others didn't see the same thing. But either way, that's -- we just want to make sure we call it out as being transparent as we possibly can. And that was the order of magnitude that we saw in the quarter. As far as the spin and having both Dental and Spine together, if you're going to spin a business, you want to make sure that it has a reasonable amount of scale, obviously, for it to be a viable publicly traded company. We feel that $1 billion-plus is kind of that number. Although there's not obvious reasons that you would look at from a strategic standpoint that those businesses would be together from a commercial perspective, there is a lot of capability and know-how and materials that are used for implants across Dental as well as Spine that there is some value in. And so it was really more around the idea of scale and the importance of that scale and utilizing those competencies, if you will, on those raw materials that go across those 2 businesses. And that was the reason why we spun both together.
Operator:
Our next question comes from Joanne Wuensch with Citibank.
Joanne Wuensch :
So as you think about spinning this out in the next 18 months, what do you need to prepare? And does it accelerate tuck-in acquisitions or anything in terms of spending so that the next company heads into its stand-up phase in a good position?
Bryan Hanson :
Yes. I would say it's generally business as usual for most of the organizations. We're going to continue to focus where we have. We've got pretty good separation between businesses. So it's not going to be highly disruptive. There's a lot of work to be done. Don't get me wrong for this thing to occur and to occur as effectively as we wanted to. But it's not going to be disruptive to the 2 organizations because they're pretty again separated today. But yes, we're actually increasing, not a significant amount, but increasing spend in these businesses to get them a good tailwind coming into the spin itself. And if there was small opportunities for us to spend capital over the next 12 months, that would make sense to again, to bolster that portfolio, we would certainly consider it in the same way that we would have beforehand. But we want to make sure that we're setting up NewCo to the first success. And we're very close on a CEO to bring in, and that person will bring leadership right out of the gate. And so that's really the way we're looking at it. If we can give them a little more money to spend to get things going, that's what we're going to do here in 2021. And if, again, very small deals, but if there were things that we could do to, again, bolster their portfolio, we'd do that as well.
Joanne Wuensch :
And a quick follow-up question for Suky. How do you think about us modeling over the coming quarters in terms of sequential improvement, starting with the fourth quarter commentary?
Suky Upadhyay:
So Joanne, as I said, it's difficult to predict at this point until we start to see a little bit more stabilization in our -- some of our key or larger markets. If you go back to last year, we're hopeful that this is a 1 to 2-month trough, and we begin to see a V-shaped recovery as we did last year within Q2, leading into Q3. If that happens into Q2, and we start to see stabilization of market growth in the back end of the year and then potentially that tailwind that we've been talking about with preferred patients, that could present a nice trajectory for us and one of those pathways to potential growth for this year. But it really is just too early to tell. As we’ve done over 2020, we will keep you updated as we learn more and as we understand how this impacts our business.
Operator:
Our next question comes from Chris Pasquale with Guggenheim.
Chris Pasquale :
First one from me, just hoping you can give us any more clarity on the timing of the new ROSA Knee and Hip applications. I think I heard you say late '21 for hips. Just trying to get a sense for whether either of those can really have an impact this year?
Bryan Hanson :
Yes, we think both will have an impact this year. Obviously, the U Knee will be first -- will be in the first half of the year. That's one that we are very excited about. We have a significant share of the U Knee market, and we're excited to be able to bring robotics to that market. And then hip will be second half of the year. And even though second half, we still believe it will have an opportunity for us to be the hit number in the back half of the year.
Chris Pasquale :
Great. That's helpful. And then can you talk a little bit more about the performance at ASC and how you see those individual positions heading into '21? I'm curious whether there's any notable differences between them in terms of how you finish the year and whether you're seeing any opportunities within extremities, in particular, to take advantage of some of the disruption in that market?
Bryan Hanson :
Yes. I mean, for us, obviously, S.E.T is not all created equal. We talked about sports and extremities as being key focus. Upper extremities is the here and the now. Lower extremities would be more in the future. In sports, is the here and the now with the recent acquisition that we did to tuck-in -- to fill in some product gaps that we have. But we feel good about all 3 of those areas. And our ASC presence, again, with the tuck-in acquisition that we recently did to give us more scale in the ASC and the contracting team that we put into place, was not as fulsome yet as hip or knee, but it's getting there pretty quick. So our confidence level is high that we're going to see the growth rate that we need in S.E.T, and it's going to be driven by sports, it's going to be driven by extremities, and it's going to be driven by our presence in the ASC.
Operator:
We'll take our next question from Kyle Rose with Canaccord.
Kyle Rose :
So I'll ask my -- both of my upfront. First is, Bryan, you talked a lot about data and the ecosystem -- connected ecosystem. Can you kind of just help us understand how that translates relative to revenues or driving lower cost? I mean, you changed the commercial model? Does it help you develop better technologies? And these have good long-term outcomes. But I'm just trying to understand how this drives incremental growth longer term. And then, obviously, you're having great success with ROSA in robot placements. Help us understand maybe utilization there and then maybe any benefits you're seeing with respect to price and mix on the actual implant side?
Bryan Hanson :
Yes. If you think about it, we're trying to attack is the fact that 20% of patients in the knee right now are still not satisfied with the outcome that they have. That's a pretty significant number. And we truly do believe that the ecosystem is going to be able to help resolve that disappointment in any procedure. And that's good for everybody, by the way. As we move down this path, we make those outcomes at better as a result of capturing the data and then making different decisions as a result of the data, that's going to allow us to get better outcomes. And when that occurs, you're going to have more patients get bold enough to move into the funnel because it's underserved today. There are patients that need a knee procedure that are afraid of the outcome, are not competent as a result of it, and they're not entering the funnel. So as we can change that outcome, and we believe we can, then we're going to have more people into the funnel, and let's get to the entire market. That's the way we're thinking about data and informatics and driving better outcomes over time. As far as ROSA goes, I'll tell you, I'm excited. We've got one application in our robotic system. I think that's what people -- remind people of just one application, there's 2 more coming this year, but there's one right now. I mentioned in my prepared remarks that we were at the higher end of our placement goal in 2020. But what I would tell you is that in reality, we were above that number. When I say higher end, I actually meant above 300. And the quarter was significant. And I think this is really important. We placed over 115 units in the fourth quarter, which was just an outstanding performance by the team. And what I love about that is that happened in concert with one of our other players in the marketplace, one of our competitors also having a record quarter in the fourth quarter. And that's good news because that tells you that orthopedics is open for robotics -- wide open for robotics. And that tells you that you've got an opportunity for all boats to rise as a result. So we truly do believe that the market is accepting of robotics, it's moving quickly, it's hitting the pivot point, and it's going to be very accepting, we believe, as well of the data and informatics that can come with it.
Suky Upadhyay:
Yes. And if I could just build on what Bryan said, it was a question earlier about the strength of our U.S. number in recon and yes, absolutely, we had some benefits due to timing. But one of the great things about some of that benefit that we saw is really -- it came because of some stocking because of new accounts and account conversion. And I think that's yet another proof point of the strength that we're seeing in our commercial execution and with our new products. So we had a really strong quarter, no doubt in the U.S. We'll continue to see momentum for all the products that Bryan mentioned earlier. And that just actually accelerated in the fourth quarter. And now we've shown it consistently for a few quarters. So we're pretty excited about where this is leading into 2021 and even more excited about where that potential is through recovery and post recovery.
Keri Mattox :
I think we have time for maybe one last question before we hit the 9:30 time.
Operator:
Our next question comes from Kaila Krum with Truist Securities.
Kaila Krum :
Just 2 quick ones on portfolio management. I mean, it sounds like you'll continue to do tuck-ins. But I mean, first, is it fair to say you'll now focus on these core areas in orthopedics? And then second, I'm curious, do you think that a different portfolio of buying products with greater scale can be more synergistic with your ortho business? Or do you simply think that there are limited synergies between the spine and ortho markets overall?
Bryan Hanson :
Yes. So our strategy around M&A and how we would spend capital dollars to augment the portfolio is unchanged. There are certain categories that we've talked about in the past where we believe we have a right to win, that we have a brand recognition that gives us that right to win, and there's a path for leadership as a result of that. And they're profitable. And those are really the main things we're focused on. How do we enter into spaces, build scale in faster growth markets, where we have a right to win, and we have a path to leadership and the profitable businesses. And that wasn't the case for us for Spine. But it doesn't mean that Spine can't be a very attractive business. It's just not one that we would invest in to become a leader because there's other opportunities for us to spend in sports or extremities or thoracic that are just more attractive markets and more profitable. So we would look at these as being better as a result of that as separate businesses versus a part of our portfolio. And I don't believe -- and we certainly haven't seen that there's a real benefit in having even a fulsome spine business in concert with large joints or S.E.T. We just don't see a lot of contracting -- large contracts that pull-through either one of those businesses.
Keri Mattox:
Great. I think that takes us to 9:30. We'd like to thank everyone for joining us on this morning's call. Of course, the IR team, and -- of course, the team will be available today if there are any further questions. I'm sure we'll be talking to all of you. Thanks so much and have a great day.
Operator:
Thank you again, for participating in today's call. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet Third Quarter 2020 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today, November 6, 2020. Following today's presentation, there will be a question-and-answer session. At this time, all participants are in a listen-only mode. [Operator Instructions] I would now like to turn the conference over to Keri Mattox, Senior Vice President, Investor Relations, Chief Communications Officer. Please go ahead.
Keri Mattox:
Thank you, operator, and good morning everyone. I hope you are all well and safe. Welcome to Zimmer Biomet's third quarter 2020 earnings conference call. Joining me virtually today are Bryan Hanson, our President and CEO; and CFO, Suky Upadhyay. Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by the forward-looking statements due to a variety of risks and uncertainties. Please note, we assume no obligation to update these forward-looking statements even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties in addition to the inherent limitations of such forward-looking statements. Additionally, the discussions on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within the earnings release found on our website at zimmerbiomet.com. With that, I'll now turn the call over to Bryan. Bryan?
Bryan Hanson:
All right. Great, Keri, thank you. And here now with our third virtual earnings call, it was hard to believe that so much time is already passed as we live inside the pandemic environment. But either way we're here, and I certainly hope that you're listening somewhere safe and socially distanced. We're clearly taking precautions here and we continue to follow our safety protocols and that's the reason why Keri, Suky and I are in different locations again for this call. As we've seen in the past hopefully we again do not have any jet mishaps, but just know if we do for whatever reason will push fast and make sure that we move forward. So, 2020 has clearly been unlike any of the year in ZB's nearly 100-year history, as I'm sure it is for every company that's out there right now. And as you know, I think we're all probably too aware, it's not over yet, it's definitely not over year. And that said, I have to say that look at how we have managed and just really navigated COVID-19 this year and specifically in the third quarter. And I'd say that I'm proud of the team, I am confident about ZB's future, I'm more confident now than they ever have been about ZB's future. I truly believe we are well positioned for success and our strategy is absolutely working. As you all know, we've been acutely focused on transforming ZB since I joined the company that's almost three years ago now. We face challenges before and while nothing could have ever prepared us fully for COVID-19, I do believe our ability to rise to those earlier challenges and then truly put us in a stronger position to effectively manage the pandemic situation, the environment that we're in right now. I actually think it's been a catalyst for ZB. The team is focused on our mission, our strategy, how we show up and execute every day is the strongest it's been since I joined the company. And the way I look at it is the things we can control, we are absolutely galvanized around and executing flawlessly against. So, it feels good right now it's much as it's noisy around as the COVID. The execution inside the organization is as strong as I've seen. And that said, the unpredictability of COVID means there are several variables and unfortunately they are pretty big variables that are outside of our control. And as a result, the pandemic continues to be challenging. It continues to be fluid. This requires us to quickly adjust to change given the changing environment. So, ultimately, we can effectively meet the needs of our customers, and very importantly our patients at all times and that's exactly what we've been focused on. Along those lines, there are really three key areas that I'm going to talk about today that I think are important for you take away, be aware of and also see the progress that we're making inside of each. The first one, you should be pretty obvious, it's our view of the COVID-19 recovery path from here, where we see it going. And I think importantly inside of that the areas of concentration or execution that we're going to have inside of the COVID recovery path. The second is an update on our strategy to drive long-term growth and through that value for ZB and for you. And the third is an update on the ongoing transformation of our business, which I truly do believe we're making great progress on. And again I'll spend time on each of these and then I'll pass it to Suky, he's going to give you more detail and color about Q3 on the financials and then how we're thinking about and framing Q4 in our minds. So, first, let's talk about the recovery and execution we saw in the third quarter. Ultimately, the recovery of the electric procedures going from Q2 to Q3 is encouraging. I would imagine is encouraging for everybody at this point looking at Q2 to Q3. But it's still difficult to predict from here what's going to happen. The fact is, we've talked about how the key variables impacting procedure volumes needed to remain constant, obviously they can improve, but they needed to at least stay where they were for the recovery to continue and to see sequential improvement from Q2 to Q3. As you probably remember that we said that these variables included both positive and negative influences on procedure volume. On the positive side, which we pretty obvious, we have the new patient volume and in the backlog of patients that had deferred treatment during the pandemic for whatever reason. On the negative side, we have the effects from the economic downturn, but most importantly surges in the virus that can drive negative policy decisions and/or increased patient fear. Those would be the negative influencers, obviously, if I look at the combination of those in terms of recovery in Q3, the variables played out in a way that allowed continued improvement over Q2. So, overall, the full quarter were stronger than expected and we actually returned to growth over 2019 faster than we thought we would. And this was driven again by these COVID recovery dynamics, but importantly, our team's strong focus on and probably even more importantly execution against our strategy. We've been very focused on moving the strategy forward regardless of the noise around us. We saw a steeper rate of recovery in July, followed by a more modest recovery or even a flattening of the curve toward the end of the quarter. And this was driven by the shift in the recovery variables that I just outlined a minute ago. We've seen continued increasing surges of the virus, especially in Europe, Middle East and Africa and in the US, and this is negatively impacting both patient fear and in certain areas policy decisions. And as a result, we exited the quarter with September growth flat versus 2019. There is not much we can do just end the virus surges, but we have launched a unique and a very large scale direct-to-patient campaign focused on patient fear, right. So, we can't influence the virus, but we could try to influence patient fear and the focus of the campaign is to educate and support patients about their options to get procedures during COVID and really even beyond focusing on the fear the patients typically have to come and get a procedure. And what we're finding early on in this campaign is that the feedback has been very positive and in particular associated with the concept of mymobility and its ability to allow for virtual care capabilities during this challenging time. All right. So, those are obviously some of the factors surrounding COVID and its recovery dynamics. But I also want to make sure that we spend time talking about the things that we have more control over, the execution of our strategy and the performance of our business inside the impact of the pandemic. And even in the midst of this turbulence, we continue to deliver against our goals. This focus and execution against our strategy is the reason we have performed well over the last two quarters versus the overall market. And specifically, if you look at Q3, our performance in US knees and hips is a great example of this underlying momentum. We grew 3% in the quarter in US knees. We also saw 10% growth in US hips. Like I said, these numbers are strong even without the backdrop of COVID. So, the question is going to be, what's driving the performance, I'm sure I'm going to get that right away, so I'm just going to answer it now. Our core business is strong really for four major reasons in the way that we view it. The first is pretty obvious, we have truly shifted from this triaging of execution challenges to launching meaningful innovation. Now, I'm going spend a little bit more time on this one in particular, but that's a big one. Second, our operating mechanism and really the resulting operational discipline has never been stronger, and I would argue probably as good as I've ever seen it anywhere. And third, our compensation programs have shifted towards disproportionately rewarding growth not just paying you for keeping the business you have but truly disproportionately paying and rewarding for growth. And then finally, and I'm not sure if this was causing it or because of it. But our commercial confidence is higher than I've ever seen in my tenure here at ZB, the commercial confidence, the swag or whatever you want to call it, is higher than I've ever seen. So, again, those are really the combination of things that is helping create the momentum inside the pandemic. But let's talk specifically about innovation that as a component of this equation. Broadly speaking, over the last year, we've taken a very dismal, a low single-digit vitality index to a low double-digit number, and that's still not as good as we'd like it to be, but that's a pretty big jump. And with our current product pipeline, I could promise you that's only going to continue to move in the right direction. And as you know obviously vitality index speaks to the percent of sales, driven by new product launches. So, in other words, those products that have been launched within the last three years. The revenue associated with them versus your overall revenue. So, again, a real nice jump in the right direction in vitality index and more coming. But to get a little more specific, I think, go to some of the key launches that you're interested in and I'll start with our knee franchise, our ROSA execution continues and I'm very proud to report that we have already passed the 200 ROSA Knee placement mark in the worldwide placement strategy that we have. And importantly, our utilization continues to increase and the placement pipeline remains very strong. So, again, remember we're way under penetrated in robotics for our business in across all of orthopedics. So, the tailwind associated with ROSA in our opinion is going to be around for a while and it feels very good right now. On the Persona Revision side of things, we keep gaining traction in the marketplace with this product launch, Q3 results were even stronger than the last quarter, which had been our best quarter to date post the launch. And Revision remains on track as I said before to hit $100 million of gross revenue this year, and that's 40% of that will be new growth. In other words $40 million of net of cannibalization revenue this year from Persona Revision by itself. This is really exciting and not only because it shows strong momentum for Persona Revision, but it also opens the door to more growth. Revision System is truly a tip of the spear product. When we converted competitive surgeon to our Revision System, we absolutely have the right to hunt for their primary knee business and that's exactly what we're going to do. And if you know about this marketplace, you would also know that the primary business is usually much larger than the Revision business. So, you can get the order of magnitude of opportunity we have to go after now, so exciting stuff there on the knee side. Shifting to hips Avenir Complete is really, still outperforming our expectations for 2020 that's even with the pandemic impact. These are the expectations that we have for 2020 before we knew about the pandemic, just to give you some perspective on that on how well it's doing. And this launch has really helped provide a great implant to leverage the high growth direct anterior approach submarket in hips, that's one of the most attractive sub-markets in hips in US implant [ph], the perfect opportunity for us to take advantage of that attractive market. And then one more product I'll highlight in the quarter is in our upper extremities business, our Signature ONE Planner, I talked about this last quarter as well. We had another 50-plus-percent increase in surgeon registrations in Q3 and we already have one in four cases using pre-surgical planning for shoulder replacement. This increased penetration of the system is important in my mind two very important ways. First of all, there is a real potential for mix benefit where maybe said another way, share of wallet gain in each procedure that you use pre-surgical planning in and it also provides more stickiness with the surgeon, right, on the surgeon's stickiness it's probably obvious when surgeons using our implant and they're also using a pre-surgical planning, it's harder for them to want to move away from that environment because they are used to it. On the share of wallet benefit, this is may not be as obvious, but it's pretty significant opportunity. It comes because you get a higher utilization in augments and guides when you do a pre-planned procedure versus those without pre-surgical planning is because you know the anatomy before you get in and you know that if you're going to have an anatomy issue, you've already got your augments ready to go and guys ready to go. That's great for the patient because they are going to get better outcome, it's great for the surgeon because they have what they need to do the procedure, and it's great for us because we get more revenue for that surgical procedure. And so very exciting stuff. And so, in short, I would just say that even with the challenges of COVID, we're driving our business forward, meeting our customer needs and improving patient lives as we go. That's the whole missioning [ph] of this organization, right. And it truly is what we do and wake up for every day, alleviating the pain of patients around the world and improving the quality of their life, and we are doing that during COVID. And as a team, we've dealt with many challenges over the past three years. We've prepared us for this moment. I've said it before, this fits on when companies and teams can slow down. They can hesitate, they can take their foot off the pedal. Hey, we're being smart and safe, but we are not letting up and it shows. It shows in the ZB performance and in the energy of this team right now. All right. So, I'm going to move on to cover our strategy to deliver long-term organic growth and ultimately drive more value for ZB and very importantly for you as well. And as we've outlined to drive our strategic pillar of top quartile performance in TSR and truly bring value to you. And ultimately, to achieve mid-single-digit growth, organically, we have got to focus most intensely on driving long-term growth in our key focus areas. And, first, as we've said in the past, the first and foremost area of concentration is above market performance and needs. Just given the size and the scale of this business, we need to be ahead of market here and we're going to do that by focusing aggressively in the fastest growth sub-markets of knee, robotics, data and informatics, cementless, and for us revision. These are the areas of concentration and investment that are going to allow us to sustainably perform above market in knees. And next, we've got to drive consistent at market growth, if not the higher end of market for our performance in S.E.T. And that's focusing on the most attractive sub-elements of S.E.T. For us that's going to be sports and it's going to be extremities. Also, we've got to make sure that we have a consistent at market performance in hips that's in the short-term, right. In the longer term, when we launch into robotics, we absolutely expect above market growth in hips as well. And then finally, while our other businesses, at least at this point, will not receive the same level of investment and will be managed differently, we still expect these businesses to drive in line to the lower end of their market growth. And that's our pathway, that's our pathway for long-term durable 4% to 5% organic growth rates in this business. Okay. So, next I want to talk about ZB's transformation. You've probably heard me outline the three phases of our ZB transformation, now I'm just going to go over them again just quickly here. Phase 1, capturing the hearts and minds of the team, truly capturing the hearts and minds of the team and addressing our execution challenges that was really Phase 1. And with this in mind, we have aggressively shifted to the One ZB mission to One ZB culture, we've added new and very diverse executive talent and we've stabilized the business across all key areas. So, good progress in Phase 1. Phase 2 was really around shifting to a disciplined strategic clarity for the organization, that's more focused on long-term success, not solving problems but truly long-term success. This is where ZB shifts to innovation, drives our strategic plan, has our pillar priorities that are very clear to the organization, locks in our operating mechanisms and involves organizational structure to ensure that we can drive a focused approach to execution of this strategy. In Phase 3, is where we transform for the future. Through active portfolio management we look to change the portfolio complexion to accelerate growth, all right. So, we have made pretty significant and really durable progress in Phase 1. We've laid the foundation for and are absolutely executing against Phase 2 and now we're moving squarely into Phase 3 of the ZB turnaround. And so for us, when I think about Phase 3, I think about that active portfolio management includes three main components and really should include these same three for anyone who is looking at active portfolio management. But the first one is disproportionately investing in our priority businesses, in our priority markets and that would be across research and development commercial infrastructure, just mind share being disproportionately invested in those areas. For number two, being selective in M&A, prioritizing opportunities that are accretive to our weighted average market growth and aligned to our strategy, so selective M&A. And the final one, when appropriate, and in line with our overall strategy divesting non-core assets that are financially less attractive in our core businesses, right. So, those are the three components of active portfolio management in a way that we see them. As we manage the ZB portfolio, we're going to continue to focus on high-growth areas and areas where we truly believe we have a right to win. No size is going to be a factor here, particularly in the short term. And out of the gate, here we can have a preference towards smaller tuck-in deals that can be easily integrated and operationalized while also maintaining very importantly our investment grade rating. And I really do believe this philosophy is apparent when looking at the recent transactions we just highlighted in our earnings press release. Again, while these deals are not material in terms of acquired revenue they are absolutely instrumental in filling some of the product gaps we have at ZB in our ASC in sports portfolios and really they add to our pipeline of new technologies and product launches in markets that are accretive to our growth rates. And these deals are small. So, they're going to be easily integrated and we're going to be able to validate our new deal process, our new team, the integration playbook that we now have in place. So, I think, great first step in the M&A side of things from a -- looking at the individual deals, if I look at the acquisition of incisive. This is an OR solutions company in the $1.2 billion integrated OR market. And this is going to provide ZB with a soon to be launched, it's now launched yet, but a soon to be launched surgical booms and lights portfolio that will help us push more aggressively into the attractive ASC market, which is clearly an area we want to go. We also see some real differentiation, it's not just filling the gap of the portfolio, it shouldn't bring [ph] a differentiation for really two reasons. First of all, we have a smaller footprint and this focuses on reducing the acquisition cost but also the construction cost, which we know is a pretty important aspect of the ASC market, looking at controlling these costs. And the second reason why we think it's differentiated is we've really done a really interesting job incorporating an innovative and automated way to capture data in the operating room that ultimately leverages artificial intelligence, and that helps us in the operating room drive efficiency and productivity and potentially even better outcomes. Again, this is really lending itself to the needs of the ASC setting. So, again, pretty excited about this portfolio opportunity. This idea of a smart alarm and really leveraging data to drive decision support and efficiency is also reflected in our exclusive relationship with [indiscernible]. Through this partnership, we actually see the opportunity to further differentiate our knee ecosystem, which is a major focus of ours right now. Our goal is to launch an intelligent Persona total knee implant that incorporates smart sensor technology. We feel the combination of active data capture from this smart implant that we already have from mymobility and we already have from ROSA is going to provide an unmatched dataset that ultimately could be leveraged through AI for a decision support related to how best to treat and care for the patient. This will give us a unique opportunity we feel to create an intersection between the $4 billion total knee market and the telehealth solution space, which is growing somewhere north of 15%, so a very attractive area for us to differentiate the ecosystem and kind of enter into an adjacent space in telehealth. And the last deal I want to talk about is our acquisition Reline [ph] and this is focused on the sports medicine market, which we know is a $5 billion market and it's growing 5% to 7%. So, again, accretive to our overall weighted average market growth. And this deal clearly helps fill our gaps in arthroscopy capital. The capital makes up about 30% of the sports market, till now we had absolutely no offering in this space. With this acquisition, we have not only filled the gap, we also see some real differentiation in the portfolio. They have done a nice job of again innovatively consolidating three tower components into a single comprehensive system, both at the equipment side and on the end [ph] vector side. This is the first in the industry. This system is very early in commercialization stage. But I would say it's getting very positive feedback early on, and we see this as another great opportunity to drive a successful product launch, leveraging our ZB commercial infrastructure, which we absolutely know we can do. So -- and I would just say, hey, we've got other portfolio management opportunities in the near term funnel and we're not ready to talk about those yet, but we have [indiscernible] the funnel and we will continue to keep you up-to-date as we make progress here. And finally, we are fully committed to our margin expansion goal of at least 30% operating margin by the end of 2023. And Suky is going to talk more about this, but our restructuring plan is on track and the cost savings we're delivering will help drive margin expansion, which has got to be there, but also support reinvestment in the business for growth. It's got to be able to do both. And that was what the whole idea of behind the restructuring plan was. So, again, Suky will give more detail on that, but it's on track so far. Overall, we are clearly watching the COVID recovery trends closely and completely realize as everybody does the short-term market performance and I want to reiterate market performance is out of our direct control as a result of the COVID recovery trends. That said and I hope it is very clear, we feel confident in ZB, we feel confident in our business strength in our execution and the long-term growth prospects we have as a business. And as a result of that the value creation opportunity we have as a company, okay. And with that, I'm going to turn the call over to Suky, again, for more financial details for the quarter and looking forward. Suky?
Suky Upadhyay:
Thank you, and good morning, everyone. To echo Bryan's comments, ZB's underlying fundamentals remain strong. Overall, our Q3 performance was better than expected. Revenue was ahead of expectations as we posted operational growth due to faster market recovery across most developed markets in tandem with strong commercial execution. Improved revenue performance drove better margins and a solid quarter of free cash flow. I've a genuine feeling of pride in how our 20,000 plus team members have responded to a very challenging environment. Net sales in the third quarter were $1.9 billion, a reported increase of 2% and constant currency increase of 1.1% versus the same period in 2019. Sequentially Q3 improved over Q2 as expected. Inside of that, we continue to see variability and recovery by market and region as we progress throughout the quarter and we did see a flattening of the recovery curve with September effectively flat versus the prior year. I'll talk about performance across our regions and then move to our business segments. And moving forward, unless I note otherwise, my comments will be on a constant currency basis. Beginning with Asia Pacific, the region returned to growth, increasing 0.7% versus Q3 2019. We saw strong performance in China with results well ahead of normal levels and while Japan has not yet returned to prior year volume, so market continues to show stability. Australia, New Zealand made steady progress in Q3, but were negatively impacted by surges of the virus late in the quarter. Finally, India and other small Southeast Asian countries continue to significantly underperform the broader region. EMEA decreased 5.7% while we saw recovery from Q2, the region did not return to growth in any part of the quarter and we observed a slowing in September due to recent COVID-19 surges and corresponding policy actions. Developed countries excluding the UK showed the strongest signs of recovery, but decelerated in the latter part of the quarter. The UK in emerging markets continue to be a significant drag on overall regional growth and are lagging developed markets recovery. Lastly, the Americas region continued to grow, increasing 3.3% with strong growth of 5% in the US. While the recovery was robust in the US, we observed the same flattening in the recovery curve due to increases in virus surges in September. Similar to Q2, caseloads in elective procedures in hard hit regions are continuing at about 70% to 90% when compared to 2019 volumes. Outside of the US, the rest of Americas continues to lag with numbers well below normal levels. Turning to our business performance for Q3, the global knee business declined 1.4% versus Q3 2019, a marked sequential improvement from the 47% decline we saw in Q2. The US knee business returned to growth, increasing 3% in the quarter. Overall execution was strong with continued momentum for ROSA. Additionally, our persona family of primary revision and partial knee continues to get great traction with existing and new customers. Our global hip business increased 4.4%. Another big sequential improvement from the 31% decline we saw in the Q2. I do want to call out that US hips increased about 10% in the quarter, strong market recovery for sure, but also a great illustration of our commercial team's execution in the backdrop of new product introductions. Sports extremities and trauma sales grew 2.5% over Q3 2019. Notably, the Americas grew about 6% but that growth was offset by softness in EMEA and Asia Pacific. Also strength in upper extremities was partially offset by slower growth in sports and trauma due to lower social activities as a result of COVID. Dental, spine and CMFT increased 6.5% due to strong execution, new products including robotics and market recovery. And finally, our other category was down 11.1%. I'll now walk through our third quarter P&L and liquidity and then share more color and insights that may provide shaping of our expectations for the remainder of the year. So, moving on to the P&L, as we have previously discussed, we move quickly and have taken a disciplined, proactive approach to mitigate the earnings impact of the pandemic, while also enhancing ZB's liquidity profile. Results in the third quarter were better than we expected at the time of our second quarter call, as we saw margins, earnings and cash flow sequentially improve versus the second quarter, consistent with our revenue improvement. In the third quarter, we reported GAAP diluted earnings per share of $1.16, and adjusted diluted earnings per share of $1.81. GAAP earnings per share versus the prior year were lower, primarily due to a sizable one-time Swiss tax credit that the company realized in 2019. For additional details on GAAP results, please refer to today's press release and our 10-Q, which will be filed later today. On an adjusted basis versus 2019, earnings grew in line with revenue growth as lower SG&A spending offset lower gross margins and a higher share count. Adjusted gross margin was 70.6% for the third quarter and as expected, results were sequentially better than Q2, but lower than 2019. Versus the prior year pressure from prior period deferred costs and lower volumes due to COVID were partially offset by a favorable regional mix tailwind as we saw stronger recovery in the US and developed markets in the quarter. Adjusted operating expenses increased sequentially over Q2, driven by commissions related to higher revenues and increased commercial investments. Expenses [ph] were lower than prior year due to the early impact of our restructuring programs and due to moderated investment levels as we continue to navigate pandemic uncertainty. Overall, adjusted operating margins for the quarter was 26.3%, better than expected and driven by the favorable geographic mix in gross margin and a slower ramp on spending. Moving beyond operating margin net interest expense and adjusted other income totaled $52 million and the adjusted tax rate of 16.6% was slightly better than expected due to some modest discrete benefits in the quarter. Turning to cash and liquidity, we'll return to positive free cash flow earlier than expected totaling $287 million. This is lower than the prior year as we used a portion of our better than expected operating cash performance to reduce our AR securitization program. We ended Q3 with cash and cash equivalents of just under $1 billion and our $2.5 billion of credit facilities remain untapped. Relative to the deals that Brian referenced earlier, we expect the cash call to be approximately $80 million in the second half of this year and that will be funded through existing cash balances. Turning to Q4, our consolidated revenue outlook for the remainder of the year has a heightened level of uncertainty, given recent COVID surges that we have seen in a number of markets and due to that backdrop, we will not be providing financial guidance for the fourth quarter. So far, through October regional trends have been similar to what we saw for the full third quarter except for EMEA. That is Asia Pacific and the Americas continue to grow in line with full Q3 growth rates, albeit with more pressure or risk in the US due to increased virus surges. On the other hand, EMEA has worsen due to surges in the virus as declines have accelerated in October with some governments in the region taking new policy actions to limit elective procedure. We expect consolidated Q4 revenue performance to continue to be fluid based on the major variables impacting the recovery, which include the rate of pull-through on the backlog patient anxiety and elective procedure capacity constraints due to COVID surgeons and/or resulting policy actions. While market dynamics remain uncertain [ph] what I do know is that our commercial and supply execution combined with our innovative new product introductions, will continue to drive strong performance relative to the market. Looking ahead on gross margin, we expect sequential improvement, but continued year-over-year pressure due to the same drivers we saw in Q3. Adjusted operating expenses are expected to be sequentially higher in Q4 but down versus prior year as we also saw in Q3. Interest expense will be stable to Q3 and we expect that our tax rate will be slightly higher than Q3 2020. Lastly, fully diluted shares outstanding are expected to step up in Q4, due to the exercise of options as a result of the acceleration of stock price we saw in the third quarter. Longer term, we remain committed to our target of at least 30% adjusted operating margins by the end of 2023. Our near-term initiatives relative to reorganization, consolidation and zero based budgeting, as examples, are complete or near completion. And we are steadily advancing our longer-term structural initiatives around supply and G&A efficiency. To summarize, our underlying business performance is strong. Our execution is on point and ZB's transformation is delivering positive proof points even in the midst of the challenging pandemic. We continue to believe that ZB is well positioned to address near term challenges and to accelerate growth over the long term. With that, I'll turn the call over to Keri.
Keri Mattox:
Thanks, Suky. Before we start the Q&A session, a reminder to please limit yourself to a single question and one follow-up, so that we can get through as many questions as possible during the call. With that operator, may we have the first question please.
Operator:
Thank you. [Operator Instructions] Our first question comes from Ryan Zimmerman with BTIG.
Ryan Zimmerman:
All right. Thank you. Good morning, everyone. So, Bryan, I want to start on the backlog and the commentary about in September exit rate. And then I have one on ROSA. If you recall back, the last quarter you talked about $700 million backlog for ZB. And I'm just wondering if you could comment a little bit around that backlog in terms of what do you feel like you achieved against that in the third quarter, and how we should think about that maybe refilling back up in light of some of the dynamics of COVID in the fourth quarter here that you're talking about?
Bryan Hanson:
Yes. So, I appreciate the question. So, what I would tell you is that the -- what we saw in Q3 because we actually saw a positive growth relatively in line, if not a little above say, for instance, in hips in like a typical market growth. That would indicate that we did not build further backlog or deferred patients in a way that I calculated in Q3. That said, we still have hundreds of millions of dollars of deferred patients that will eventually come back in the funnel. So, I still feel very bullish about the fact that we have these deferred patients. There are patients, as we know for most of our business that has a disease that progresses. It does not get better by itself. And as a result of that those patients typically come back in the fall. So, I wouldn't say that we built more backlog in Q3, but we certainly still have quite a bit of backlog to go through. So that's my view of where we are from a backlog standpoint. And again, I think, eventually when we get to the point where we have a vaccine that people have confidence in it or treatment that people have confidence in. We're going to have that backlog of patients begin to come through in concert with new patients and that should be a really nice headwind for our business, looking forward in that day for sure.
Ryan Zimmerman:
Understood. And then just the second question, ROSA really nice number there, the 200 -- exceeding the 200 placements on ROSA. Just talk a little bit about the visibility on the order book and your expectation for 2021. Is it unreasonable to believe that you can accelerate beyond that 200 to 300 placement rate you're expecting this year? Thank you for taking the questions.
Bryan Hanson:
And for just clarification, just to make sure that 200 to 300 is what we've done from operational standpoint since launch. And there wasn't 200 to 300 that we would expect just in 2020, but it would be since launch, which is just call about a little over a year and a half now since full launch of the ROSA System. But I'd tell you that, hey, I'm pretty enthusiastic as it the team around the ROSA placements that we saw in Q3, it was the best quarter that we've had relative to the number of installations we did in a single quarter. And I can tell you that that momentum is continuing into Q4. And even though, I think, it will be slightly better, if it is still slightly better than what we did in Q3, that's what our expectation will be in Q4. And so that pipeline, if I'm just going to call, future customers is robust as it's ever been with our product. And as I mentioned before in the prepared remarks, I really do believe the under penetration of robotics is it such a point that this is a tailwind for the organization for a long time to come. And it's a very exciting tailwind. No question about it. Because not only is it before us [ph], it's to the patient. It really is providing a level of accuracy in the operating room that you can see when you're in the operating room with surgeon. Forget studies, we've got those coming, but when the surgeon uses the robotic system in the operating room, you can see the lights go off -- I mean go on. They clearly understand that they have an opportunity to get better cuts more accurate cuts, but also and very importantly feedback right away in the operating room around tissue balancing. It's really you need to see actually to have an opportunity to go and see that kind of light bulb go off in the surgeon's mind when they're using it is pretty amazing. Relative to 2021, I don't want to give specifics there. But what I would tell you is that I would be disappointed if the level of placements that we saw in Q3 and Q4 which were better than the first half of 2020. I would be disappointed if that level of placement didn't continue into 2021, right. And that would indicate in fact that does happen that 2021 should have more placements overall than 2020 did. So, again, I think real positive momentum, great feedback from our customers and a really strong pipeline of future customers that are out there right now.
Ryan Zimmerman:
Thank you.
Keri Mattox:
Thanks, Bryan.
Bryan Hanson:
Sure. Can we go to the next question, please?
Operator:
Our next question comes from Bob Hopkins with Bank of America.
Bob Hopkins:
Hey, good morning. Thanks. Can you hear me okay?
Keri Mattox:
Yes.
Bryan Hanson:
Yes. Maybe great.
Bob Hopkins:
Good morning. Thanks. So, first quick question, I appreciate, Bryan, your comments on deals and divestitures and the two deals you announced. So, quick question there is, one, are those deals that could start to have an impact from a revenue perspective, more in 2022, just kind of how should we be thinking about those launches? And then on the divestiture side, kind of how would you characterize how likely divestitures might be in 2021? Thank you.
Bryan Hanson:
Okay. So, what I would tell you is that the deals that we just talked about, obviously, are not super accretive relative to acquired revenue growth just [ph] not much there. Think about most product launches that we have facilitating product launches in these very attractive spaces ASC, it would also be in sports, which is kind of a combination ASC impact, and then also in the data informatics portion of things. But I would absolutely expect revenue growth to be driven in 2021, I wouldn't say 2022. I definitely believe that the portfolio being provided by these acquisitions will immediately give us traction to be able to go out and hunt in the ASC marketplace, in the sports marketplace and continue in 2021 to provide more unique offerings inside of our knee category and we talked about that knee ecosystem. So, it's all three [ph] of the things that we just talked about in prepared remarks, we will provide revenue growth just not acquired revenue growth in 2021 and well beyond by the way. As far as divestitures go, clearly, I wouldn't talk about the time frame, I don't want to give anybody any [ph] expectation here. But the fact is when we think about active portfolio management that is one of the vectors. One of the obvious ones is M&A. And for us M&A that we're going to focus on will always be to build scale and or innovation that matters in markets that are accretive to our ZB weighted average market growth. And very importantly, where we think we have a right to win and see a clear path to leadership in those categories that would potentially be on the docket for divestiture. It would in those areas that are not as financially attractive to the business are not as core to our strategy and where we don't really see a clear pathway to leadership. Those would be the things that we would look at when we think about sharing the business, but I just don't want to give you a specific time frame because I don't want to set that expectation. But just know that that is part of the equation as we think about active portfolio management with the intent over time to move more of our revenue in higher growth markets, right, as we intend. If we're going to be a top quartile performer in total shareholder return, we have to have more of our revenue in higher growth markets, I'm just talked about mid-single-digits to upper single-digit growth markets and that's the intent of the active portfolio management process.
Keri Mattox:
Thanks so much, Bob. Bran, can we go to the next question in the queue, please.
Operator:
Our next question comes from Josh Jennings with Cowen.
Josh Jennings:
Hi. Good morning. Thanks for taking the questions. One on ROSA and then just one on your average Chinese business. Just on ROSA, I was just wondering just kind of parse out just the implant performance in knees in the quarter. Was there a headwind from third quarter 2019 ROSA upfront purchase revenues, again, versus the placement dynamic has been happening over the course of the pandemic. And just, can you help us as we think about modeling these ROSA placements out in the 2021, and just all robotic solutions out there in the orthopedic marketplace. And do you think that percentage of systems that are placed that will drive an upfront capital purchase and that upfront revenue is at a 50% bar, is at a 25%, anything you can help us just in terms of modeling out that that system revenue as we think about 2021 and beyond would be helpful.
Bryan Hanson:
Okay. Maybe I'll hit that piece first. What I would tell you is we're definitely seeing it's not dramatic, but we're already seeing a slight shift back towards customers having a desire to acquire either lease or acquire the robotic systems and it almost seems like it's already starting although not nearly at the pace that it was, let's say, last year. And so I would guess, it's purely a guess, but I would again based on that assume that as we move into 2021 you might see more of a shift in that direction. But I just don't have a good sense for where it's going to land. I'll say [ph] it right now, it's definitely the larger portion of installations are these placement programs which is truly what we would prefer. I really like having that longer-term contract in relationship with the customer that does require certain volume commitment to the company and we're just building that relationship in a more stable way. But I would assume that as our customers get more confidence in the market that they may want to shift back to where they were before which is maybe acquiring more. I just don't want to give you a sense for what the percentage would be, but it is moving slightly back in that direction. Relative to Q3, interestingly enough even though there were some sales of ROSA in Q3. On a relative basis, it was actually a headwind for us. If I think about US knees particularly I talked about 3% growth in the US knees. If I eliminated ROSA as a part of that and just looked at core knees, and base knees, we actually grew closer to 4%, even a little better than 4% in base knees in the US. So, it was almost 100 bps of -- actually a little more than 100 bps of headwind from ROSA in the quarter. So, hopefully that answers the question.
Josh Jennings:
That's very helpful. Thanks for those details. And then just I heard Suky call out strength in upper extremities in the quarter, are you seeing any disruption from the Stryker-Wright combination, maybe hard to parse out in the middle of the pandemic. But I just wanted to get your thoughts on the opportunity with the integration next year from second biggest competitor and what that opportunity represents in your mind for the upper extremities business? Thanks for taking the questions.
Bryan Hanson:
Yes. Absolutely. I mean, the fact is, when we look at the performance in Wright, they had a pretty good quarter. So, clearly, at least based on that performance one would indicate that it's not disruptive yet. Always hoping for things to happen, I would be very happy if there was disruption when you try to bring those two organizations together finally. The fact is, most of the time in our industry when they're bringing two organizations together is dis-synergy risk there just is. And that's why I like some of the small deals that we just did, it really eliminates that dis-synergy risk because there are really more product launches versus bring two sales organizations together. So, I would expect at some point just given the historical views of acquisitions in our space that you are going to see some level of the dis-synergy and hoping that we have an opportunity to take advantage of that. That said, I hope is [ph] in a strategy we have a very clear strategy in our extremities business and we're executing against that. And I feel very confident in the commercial infrastructure we're putting together, the product pipeline that we have and the traction that we're getting in the marketplace right now with or without disruption from our competitors.
Josh Jennings:
Thanks, Bryan.
Bryan Hanson:
Thanks.
Keri Mattox:
Thanks so much.
Operator:
Our next question comes from Vijay Kumar with Evercore ISI.
Vijay Kumar:
Hey, guys. Thanks for taking my question and congrats on a footprint [ph] here. Bryan, maybe a big picture question, if I look at 2021, Street's modeling earnings above 2019, I'm just curious a couple of your peers have called out gross margin manufacturing variance et cetera. Is there anything you need to be aware from a margin perspective, and should the Street perhaps -- are you guys comfortable with the Street EPS numbers?
Bryan Hanson:
Maybe what I'll do for that one is just pass it over to Suky to provide a little more color there. I know you had some of that in your prepared remarks, Suky, but maybe you can comment on that.
Suky Upadhyay:
Yes, sure. So, we're not obviously giving guidance on 2021 and I'm not going to speak to Street numbers. What I would say is next year's profile, obviously, it's going to be driven by revenue and a large component of that is going to depend on what happens relative to COVID-19. From a top line perspective, if we saw situation where the recent surges and [ph] experiences begin to abate or moderate and then stabilize, there could be a pathway to seeing a 2021 revenue profile. That's in line with the 2019 revenues. And if we got into next year and saw that stabilization moderation, but also on top of that saw vaccine or credible treatment. In tandem with the vaccine, you could potentially see volumes or revenues ahead of 2019 level. So, that's kind of how we're thinking about it from a broad strokes perspective, but there is look [ph] a lot of runway between here and there relative to COVID and how that's going to play out. So, we're going to pause on giving too much additional color beyond that. From a margin perspective, it's really going to fall in line with overall revenue and volumes, right, as you would expect. Volumes and revenue is better, so will margins. That's intuitive. I would say, as we think about our margins going into next year, there are a number of headwinds and tailwinds that we have taken into consideration using sort of second half of this year as a starting point or as a run rate. First on gross margins, we'd actually had a pretty good quarter in Q3. We expect to sequentially step-up in gross margin into Q4 based on overall volumes and seasonality that we typically see in the fourth quarter. But as we move into next year and as overall regional mix starts to stabilize with a stabilization of COVID, we're seeing a mix tailwind right now that may abate into next year. So, that could be a slight headwind, as we go into next year. And then we have had some pressure on overall COGS this year because of lower volumes, because of prior-year deferred costs. Those are going to continue into next year. So, there are a couple of headwinds in gross margin that we're closely watching. Now having said that, we're also very aggressive on our cost down opportunities and cost of goods. So, that could be a tailwind to next year. But we've always talked about coming out of 2020 as part of our broader restructuring program, the 30% operating margin aspiration that you should expect to start to see a stabilization from 2020 as you move out to 2023 when it comes to gross margin. And then within operating margin, I'll tell you we're going to continue to ramp up investment. I think, what you see over the last two quarters was our performance relative to market has been strong. One of the reasons behind that is because we've been making really smart investments and our commercial teams have been optimizing those investments and getting quick ROI those. And so we're going to continue to ramp up that spending because we got a lot of great products. We've got great execution in very strong end markets and so we're going to see a step-up in investment as we move into 2021. Having said all that we're consistent with where we were before that if we saw revenues at 2019 levels, we would expect -- we'd be disappointed if operating margin within 2021 didn't reach those levels, maybe not for the full year, but within 2021, we would expect to get to those margin levels. So, hopefully, that gives you a little bit more perspective on how we're thinking about 2021. But, again, a lot more to play out yet with COVID.
Vijay Kumar:
Yes. That's extremely helpful. And Bryan one for you on that. Thanks for all the color on the Persona Revision. I guess, when you look at next year, as you guys gain traction on the Revision side, should those, I guess, gains accelerate as you gain a beachhead into the primary side of knee as well.
Bryan Hanson:
I'm sorry, could you repeat that, I missed part of the -- the first part of your question, you went out a little bit for me. Could you repeat that?
Vijay Kumar:
So, on that the Persona Revision knee side, I think, the comment you made was that should allow you guys to go after the primary implant side as well. So, when you think…
Bryan Hanson:
Oh, I guess, yes.
Vijay Kumar:
$40 million of net gains on the Revision side, should we perhaps be looking at an accelerating share gains for next year as you gain share into -- on the primary side.
Bryan Hanson:
Yes, I'd say, it's -- that's the most exciting thing for me on Persona Revision. And probably it was a little ostomy to take impurities [ph] in the beginning, because I assume the better connection between Revision sets and primary, but what we're finding is that a good portion of that $40 million or so of competitive conversion [ph] where we have the primary business already, we did not have the Revision System. But a lot of them or the other way around, but we didn't have the primary or the Revision. And so when we pick up that Revision business, it absolutely, as I said before, gives us a right to hunt for the primary business. And it's an order of magnitude larger than the Revision business. So, if you just look at the market differential, let's call, Revision somewhere in the neighborhood of 10% to 15% of the overall knee market. The rest of it is really primary unit that are out there. And that again once we get the Revision business, we then can go after that primary, the unit that the surgeon is doing. And it doesn't mean you're going to natural get or automatically get it but you again have a right to go after it and you build the trust and you build the relationship with the surgeon and it gives you that chance. So, I absolutely expect two things in 2021, continued competitive conversions with primary and with Revision, but also that opportunity to pull in the primary business as well. And it will clearly be one of the catalysts that we use to continue to drive towards above market growth in knees just as we've been saying. It will absolutely be one of the variables that will drive us in that direction in 2021.
Vijay Kumar:
Understood. Thanks, guys.
Bryan Hanson:
Sure.
Operator:
And our next question comes from Raj Denhoy with Jefferies.
Raj Denhoy:
Hi, good morning. A couple of questions if I could, so I'm just trying to put a finer point on your comments around the fourth quarter. So, it sounds like you're suggesting that Asia Pacific and the Americas perhaps in line with the third quarter, but given that EMEA is worsening, I guess, we should assume that the growth rate in the fourth quarter will be below what you posted during the third quarter, is that a fair way to think about that?
Bryan Hanson:
Yes. So, maybe, Suky, I'll start, if you want to provide any more color feel free to do so. I would say, generally, what you're saying is accurate, I would say that Asia Pacific which is clearly being less impacted by surgeons in the virus seem to be relatively consistent. Again, it's early in the quarter based on what we've seen so far, pretty consistent with the growth rates that we saw in Q3, overall, Q3. The Americas, even though it's a positive growth, it has slightly decelerated versus Q3. But the good news is even with the surges that we're seeing in the US, we're still seeing positive growth. And it's close relative to what we saw in Q3 again, it's early. And the risk feels a little more tenuous right now because the surges are so much more prominent than they were in Q3. But the fact is that US is hanging in there and still has positive growth, but in EMEA, to your point, we are seeing more pressure. The policy decisions and the reaction to the virus surge is more acute in Europe, Middle East and Africa. No question about it. And I would expect Q4 to be slower growth and it was already negative in Q3 than Q3 was. And so we're really watching this everywhere, obviously, but right now, Europe, Middle East and Africa is a key area of focus for us to understand what's happening in that region. And then importantly, inside of that storm, if you will, what are we going to do to make sure that we stay ahead of the competition while it's occurring.
Raj Denhoy:
Okay. But maybe just...
Bryan Hanson:
Anything else you want to add?
Suky Upadhyay:
No, I think, you summarized it really well, Bryan.
Bryan Hanson:
Thanks.
Raj Denhoy:
And really my second question is, I guess, somewhat related, frankly, Suky made a comment that that demand in some areas is still at 70% to 90% of normal. And I guess I'm curious how to think about that, is that a kind of broad statement that you are still more than 10% below what you would consider normal demand, and it's going to take something like a vaccine or better treatment ultimately to get that to 100% and beyond?
Bryan Hanson:
Well, let me clarify what you're saying there is, what you're saying is that, so take the US, for instance, if you look at a specific state or a county inside the US that is being very hard hit by surges, what he was referencing is that even in those very hard hit areas, the county or the state, you're still seeing 70% to 90% of procedure volumes that you would typically see, say, versus 2019. So, that doesn't necessarily mean that broad-based, we're seeing 70%, 90% of demand, it's just, let's say that in that hard-hit area, you're still seeing 70% to 90% of typical procedure volume, so that is what he was referencing.
Suky Upadhyay:
Yes, I think, Raj...
Raj Denhoy:
Perfect. Thank you.
Suky Upadhyay:
Yes, the extrapolation from there is even in the very acute second surges, we're not seeing anything that resembles what we saw in April and May, right. So, clearly, the end markets, the hospital systems with precision, more deference being provided to them, they are better prepared to deal with COVID. They have better protocols and triage our patients, I mean, they've got incentives to get the elective procedures through. So, that's really the key point of that statement of 70% to 90%.
Raj Denhoy:
Very clear. Thanks for the clarification.
Keri Mattox:
Thanks. And Barn, It looks like we have time for at least one, maybe two more questions.
Operator:
We'll take our next question from Matt Miksic with Credit Suisse.
Matt Miksic:
Hi, good morning. Thanks for taking the questions. I have one on S.E.T. and one on, just to follow up on Raj's question on trend. So, on sports medicine, extremities, trauma, you provide a global reporting line here, it's a 20% or so of your business. I was wondering, if you could maybe expand a little bit on how the major moving parts of that business are performing and maybe proportions or geographic color would be helpful. And then I actually have one quick follow up.
Bryan Hanson:
Okay. We don't really provide a breakdown beyond the S.E.T. overall category. But what I would tell you is that the US and I think that Suky referenced this in your prepared remarks, you said I think that the overall S.E.T. category. The US was definitely the strongest performer in the world. I think, we have somewhere neighborhood the 6% in US S.E.T. performance from a growth standpoint. So, that would indicate that we clearly had lower growth in other parts of the world, which isn't surprising when you think about our S.E.T. category, say, for instance in Asia Pacific, a bigger part of that category would be trauma in that region plus other [ph] regions, just given the dominance or the significant portion of revenue in each [ph] specific that China has. And even though we're seeing less surges of the virus in that part of the world, we still are seeing less activity. And that typically will drive lower volumes and/or lower revenue growth in sports, it would drive lower revenue growth in trauma. So, just when people aren't moving as much and they are not doing as much, we typically see those two businesses with inside of S.E.T. get hurt. And I would tell you that as we talked a lot about, we've had pretty significant focus in extremities obviously upper extremities is one of the key areas of focus for us. And I would just say, our growth rate there is promising. And that's probably all the detail I provide below S.E.T. But overall, if I look at the category, the US region -- the US or the Americas was definitely the strongest growth region.
Matt Miksic:
Thanks for that. And then just on -- Suky, your comments just now on trends and what we could expect and not expect potentially around surges. Is there anything -- there was a pretty tight period, I guess, this summer in Arizona, Texas when there were some very narrowly focused constraints by county and other. I just wondering if you could talk a little bit about what you saw there? How quickly it rebounce back and sort of what we might learn from that as it pertains to maybe the next few months in some other areas?
Suky Upadhyay:
Yes, I think, we actually commented on that on our second quarter call. And some of those very hard hit counties within the states that you mentioned were operating somewhere in that 80% to 90% range. So, we've seen a very consistent pattern coming out for a few months where we've seen heightened surface. So, I think, that's again another positive inflection that we're not going to return back to those periods of April and May, even with acute surges, at least based on what we're seeing today. The time to abate, it really -- it's variable, right, there is no broad statement, it depends on the specific market, the specific sub-market that you're talking about or territory and the number of surges and how quickly -- how big that population is, and how quickly those surge rates come back down. So, it's tough to say. But in some of those hardest hits where we were at 80%, 90%, we've seen a path in some of those where they've gotten back to normal or perhaps a little bit above normal within a few months. But, again, it's really variable from market to market.
Matt Miksic:
Thanks.
Operator:
And that concludes today's question-and-answer session. I'd like to turn back to Keri Mattox for additional or closing remarks.
Keri Mattox:
Thanks so much, and thanks everyone for joining us. I know we'll be in touch today, if you have questions, please don't hesitate to reach out to the IR Team. And we look forward to continuing the conversation.
Bryan Hanson:
All right, great. Thanks, everyone.
Operator:
Thank you again for participating in today's conference call. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet Second Quarter 2020 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today, August 4, 2020. Following today’s presentation, there will be a question-and-answer session. At this time, all participations are in a listen-only mode. [Operator Instructions] I would now like to turn the conference over to Keri Mattox, Senior Vice President, Investor Relations, and Chief Communications Officer. Please go ahead.
Keri Mattox:
Thank you, operator, and good morning, everyone. I hope you are all well and safe. Welcome to Zimmer Biomet’s second quarter 2020 earnings conference call. Joining me virtually today are Bryan Hanson, our President and CEO; and CFO, Suky Upadhyay. Before we get started, I’d like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by the forward-looking statements due to a variety of risks and uncertainties. Please note, we assume no obligation to update these forward-looking statements, even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties in addition to the inherent limitations of such forward-looking statements. Additionally, the discussions on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within the earnings release found on our website at zimmerbiomet.com. With that, I’ll now turn the call over to Bryan. Bryan?
Bryan Hanson:
Great. Thanks, Keri. And before we started, I just want to say that I certainly hope that you’re safe, your families are healthy, and that you’re doing everything you can to manage through this very unusual situation that we find ourselves in. Speaking of that, once again, we find ourselves in an earnings call where we’re in different places. We’re not held together. And my guess is, as we may have some mishaps, potentially anyway, when we hand off to each other, so I’m just going to apologize ahead of time for any mishaps that we see through the handoffs here, and potentially any background noises we might get. Obviously, this is an unprecedented time for all of us, very challenging time as we deal with the pandemic here in the U.S. and around the globe. And we, as a result of that, want to talk about the virus today. We want to talk about how we’re managing through it. We want to talk about how we’re modeling its potential impact. But, we really also want to make sure that we spend some time on our underlying strength of the business that we have and our plans for long-term growth. And along those lines, I’m really going to try to center the conversation around three main topics. The first one is obviously our execution and the financial results in Q2, but really spent time in Q2 on the strength of the underlying business and why we’re feeling confident in the things that we can control. The second thing would be around our broader modeling and our assumptions on a go forward basis associated with the pandemic. May not be associating as you want there, but we’re simply going to give you the best that we can on how we’re looking at it. And then, the final piece would be just on our long-term plan for growth. What are the things we’re going to be focusing on to be able to get sustained growth in the future? So, first, let’s talk about the second quarter, and I want to begin with saying that safety, as I said, last quarter, continues to be our top priority. Safety of our team members, our customers, our patients, the communities that we serve, and we continue to execute on that comprehensive global pandemic plan that we did develop last year. Believe it or not, I said before, we actually developed that plan before this all happened. And we’ve been putting that into action at the very earlier stages of COVID-19. And as a result of that plan and our additional safety protocols, we’ve definitely seen changes to how we work and have learned a lot about how we can more efficiently collaborate across the globe, significant changes associated with that. But importantly, these safety-related protocols have not -- they have not caused disruptions in our supply chain and our ability to meet our customer demand, and then our ability to serve those patients who rely on our technology and our products to improve the quality of their life. And I’d say, I’m really proud of how seriously the entire ZB team has taken our collective safety. And I want to thank each and every one of our team members, especially our manufacturing and commercial teams, who have just gone above and beyond during this entire time, during a very challenging time. I just can’t thank you enough. So, in terms of our Q2 execution and performance, I’m going to cover some broad takeaways, and then I really want Suky, after I finish, to get into more specific detail, maybe more than what we would typically get into, just given the current circumstances. So first, the recovery that we’ve seen to date and really specifically in Q2 is encouraging. Now it’s early, but so far, it’s been better than we expected. Based on what we are seeing and really just experiencing in the recovery, there is real reason for optimism. But, given the number of unknowns related to COVID, I would say, it’s more prudent to be cautiously optimistic right now. You’re going to hear that theme throughout the discussion today. We’re watching closely and continuing to see rising patient demand, which is key, right? We’ve got to see that patient demand. And that’s resulting obviously in increased procedure volumes. And very importantly, we’re also seeing that majority of surgeons and hospitals are ramping up capacity to support that demand. It’s a pretty big variable associated with whether or not you can get that backlog patient and the new patient coming in. And so, as a result of this, our Q2 performance was better than we expected across all of our regions, and in particular, we saw strength in the U.S. And I got to say, the U.S. recovery performance is really encouraging to me, as this is momentum that we’re seeing despite the resurgence of the virus in many of our states. Importantly, this trend has continued into July, even as some of the states with the rising COVID numbers like Florida, Texas and Arizona. So again, even though we’re seeing that of resurgence of the virus, we still are pretty bullish on what we’re seeing in U.S. so far. Clearly, and for good reason, everyone is going to focus on the impact of COVID in the quarter, and probably more importantly, its forward-looking impact on our business. And we’re absolutely going to talk about that in a minute. But the last thing I want to discuss for Q2, centers more around the things we can actually directly control, even during the pandemic, and the activities that ultimately will drive durable growth and strengthen our business. So, through the pandemic, I can tell you that we have remained maniacally-focused on executing against our growth drivers, and that focus is delivering results, and we saw those in the second quarter. So, I’m going to just start with what I know everyone wants to hear about is our progress with ROSA. Now, obviously, robotics plays an important part of our strategy on a go-forward basis. And importantly, we continue to see very strong demand for ROSA, even through the pandemic. And also importantly, we’re getting very good feedback from surgeons that are using the system. And while I can tell you that I’m not going to provide the level of detail I’m about to give you, probably ever again, I do want to give you some additional insights into where we are with ROSA and the launch, just given the fact that it’s being hidden right now with all the clouds, I guess, associated with the COVID impacts on our business. So, I was just going to say, so we’re now about a year away from the full launch of our business, about a year into that launch. And we now have about 150 ROSA Knee Systems out in the globe. And the good news is, we’re seeing with those units, very strong utilization per unit. And some of those are newly placed, so you’re not seeing the same volume yet. But this has been out there for a while, we’re getting very good utilization per unit. And if I just kind of add it up and I look at the current procedural volumes that we’re seeing, we’re really on pace to be doing about 3,000-plus cases per quarter. And just to put that into context, now relative to growth, that’s more than double the procedural volumes that we would have seen in the fourth quarter of 2019. And by the way, that’s inside of the pressure on elective procedures that we’re seeing as a result of the pandemic. In addition to that, we’ve got a number of accounts in our active pipeline, a whole bunch of companies in the active pipeline. Some of those will fall out, but based on the volume of accounts in that pipeline, we’ll be very disappointed if we don’t have between 200 and 300 ROSA systems out in the market by the end of this year. So, I would just say, for ROSA, we continue to keep very-strong momentum and remain on track actually slightly ahead of our expectations for both, system placements and procedures, even with the pressure of COVID in this environment. So, good news obviously on the ROSA front. Another great example of strong innovation and commercial prowess is the Persona Revision story that we’re seeing play out and saw play out in the second floor. Our launch of the revision system is well ahead of plan, believe it or not, and receiving very positive remarks from current Persona users, which is important. But, even more importantly, we’re seeing very-positive remarks from competitive services, which is where we want to make sure that we’re focusing. In some of the key areas of feedback are really a lot of excitement around the ease-of-use of the system, a significant excitement around precision and the intuitive nature of the instruments that we have, which is important in this procedure, and also the ability to provide all the benefits of a more personalized fit for the patient that Persona brings to the table and do this in revision system, which again, is unique in the marketplace. So, just for perspective, the Persona Revision surpassed our expectations in Q2 and delivered the most successful quarter to date since launch. Let’s kind of repeat that. It’s the most successful quarter to date since launched, in Q2, which is the quarter that’s been most impacted by the pandemic. The demand is still very-robust even outside of that. We already have doubled the instrument sets originally anticipated for the launch to support that demand. And again, for context, this product is on a trajectory to reach close to $100 million in revenue during 2020. Some of that’s going to be cannibalized out, as you cannibalize revenue. And I would expect, the capitalization rate to be about 60%. So, again, on track to do $100 million or very close to it in 2020, and I would expect about 60% cannibalization of that revenue. And we also have continued our focus on driving our dedicated commercial team for extremities as I’ve talked about quite a bit. And we’ve been very-pleased that our Signature ONE Planner shoulder system continues to gain traction, again, even in Q2. Now, surgeon registrations, just to give you some perspective for Signature ONE increased nearly 60% in Q2 sequentially over Q1. And our recent FDA clearance also enables even greater integration of that system with our family of implants and guides, that’s going to open up even more opportunities. We’ve also increased the portability of the system. We’re really trying to make it more open architecture, so that you can use it on your computer, but you can also put it on my iPad or an iPhone, so that if you’re walking in and out of the surgery and the operating room, you can still use the system, increase that portability, which surgeons want. So, we’re excited again about our shoulder franchise and the impact that this system will have on our success there. And then, finally, mymobility. Our partnership with Apple continues to be a prime example of how research and development, investment in tech innovation are going to drive the next wave of telemedicine advances, and we truly believe will change the patient and surgeon experience in our space. And with mymobility, what we’re really focusing on is ensuring that we have that patient-physician communication link that’s even better than it was before, but allowing this to happen more virtually. The system also helps improve adherence to the pre and post-patient requirements because that information is the pushed to the patient when they need to actually do something. And very importantly, it’s advancing the collection and the analysis of patient-specific data points that ultimately can help the care team make the best and most personalized care decisions for that patient. In June, we announced with Apple a new application. It’s going to be able to provide now gauge quality functionality within mymobility, and that will happen this fall. And that’s a pretty exciting development and a big step forward, no pun intended, in this remote data collection journey. Again, with the idea of collecting data that is personalized with the patient and ultimately as a result of having that provide better care decisions. So, the mymobility functionality in today’s COVID environment is especially interesting because it does allow for this significant demand that we’re seeing right now for allowing effective and engaged, remote and virtual patient care. So, we’re excited clearly about mymobility, we were before the pandemic, but certainly this is giving us some additional steam in the marketplace. So, moving to the second key area of focus for the earnings call, I want to talk about COVID-19 and our modeling assumptions for the rest of this year. And we’re encouraged about what we saw in Q2 and are confident in our ability to continue to execute. But we understand, and I think probably everybody does, the near-term uncertainty that COVID-19 brings. Our thinking regarding COVID is obviously changing. It’s evolving, it’s sharpening as we experience more of its actual impact on our procedures, and over time, we’re also seeing the impact on various markets and submarkets. And so, I’d like to think about just based on that knowledge that we’re getting, we can refine our thinking here and explain it really by talking about three major variables that I think we’ve got to pay attention to. One of those variables would be a tailwind for us created by the pandemic, and then, two would be headwinds that we’ve got to pay attention to. So, the first, when we talk about the tailwind, it’s just going to be backlog of deferred patients that we have built. These are both, the initial deferred procedures that we saw in the beginning and the building backlog that’s continuing to happen. From a headroom standpoint, I really look at it two ways. One would be around those patient specific factors, patient fear or unemployment for instance, and then the second one would be around the recurrence of the virus. And I would think about that in two ways, the recurrence having an impact on actual bed capacity and the recurrence having an impact on policy decisions that could directly impact elective procedures, okay? So, that’s kind of the variables that I think about in determining where we think this is going to go. Relative to the backlog, I think, it’s really important to note that the approximate value of this backlog just for ZB, just for this company is already worth about $700 million to $800 million in revenue. That’s the approximate value of the backlog already created. It’s worth about $700 million to $800 million in revenue, future revenue. And this value continues to grow and the factor that continues to grow and will continue to grow until the market returns to normal market growth rates. Relative to the headwinds, given that we are currently seeing play out, I would say that patient fear and virus recurrence impacting specifically bed capacity are the two most significant threats. I would say that policy decisions and unemployment concerns would be less material, at least based on the rate that we’re seeing policy decisions roll out right now. So, the key takeaway -- I am just giving you a lot of information on these variables than I’m paying attention too. If the variables that I really just described, continue to play out as they are today, we would expect that sequential improvement seen in Q2 would continue through the back half of 2020, but likely at a more modest pace in Q3, Q4. Just to repeat that, if the variables that I just described, continue to play out just as they are today, just what we’re seeing today, we would absolutely expect the sequential improvement that we saw in Q2 to continue in the back half, but it would be in a more modest pace. And another important aspect of this equation, I think sometimes this is lost, so it’s important thing to bring up, is that the two most significant headwinds become non-variables once a vaccine is available. And the vast majority of those patients that didn’t get treatment for either of these reasons, become a tailwind eventually for our business, remembering that this is a progressive disease. And as a result of the progressive nature of that disease, the vast majority of these deferred patients will eventually reenter the procedural funnel and become a tailwind for us. Finally, I’d like to also spend a portion of my time today talking about the third category, which is our long-term plan for growth. And I can tell you that our strategy is relatively simple. You’ve heard me talk about it before. Not all of our businesses are going to be treated the same. All of our businesses are important to us, but they’re not all going to be invested in or managed the same. We have prioritized the high growth and most strategically relevant areas of our business. And we’re going to make very-disciplined investments there to continue to drive innovation, innovation centered around improving patient outcomes and also providing for procedure efficiencies. And to drive our strategic pillar of top quartile performance in TSR, we have to focus most intently and driving long-term growth in these key areas. Number one -- and yes, said this before, but number one, we must achieve above market growth in these. And just given the size and scale of this business for us, we need to be ahead of market here. And we’re going to do that by focusing more aggressively in the fastest growth sub-markets of knee, robotics, data and informatics, revision like I just talked about. Next, we need to see and drive consistent at-market, actually as a higher end of the market range for S.E.T. We need to see that happen for our business. And we’re going to do that again by focusing more of our attention in those most attractive sub elements of S.E.T. Also, we need to consistently deliver at-market performance in hips in the short-term. That’s all marking [ph] for us, at-market performance in the short-term but transitioning to above market growth with our future robotics launch in this space. And then, finally, while our other businesses, at least at this point, will not receive the same level of investment and they will be managed differently, we still would expect that these businesses would drive in line, maybe to the lower end of market growth for these areas. Okay. So, that’s the way we think about our businesses and the way that we’re going to invest in them. And by focusing on these markets, just as I’ve described, we believe that over time, our pursuit of consistent and sustainable mid-single-digits organic growth rates is absolutely possible. Now, to fuel the investment needed to drive this long-term growth and at the same time, drive margin expansion over time, we’ve continued to focus and execute on our restructuring program. And the last piece, when it comes to long-term growth, is our M&A strategy, and this is going to be key for us. And it remains consistent with what we outlined in 2019 and earlier this year. We will continue to focus on high-growth areas and the areas where we truly believe we have a right to win. The size is going to be a factor here as well with a preference, at least at the outset toward tuck-in deals that we can easily integrate and operationalize, while also maintaining an investment grade rating. So overall, I think it’s obvious, we feel confident in our business strength and execution, in the current pace of recovery from COVID, in our long-term growth prospects. And, we’ve already learned so much from COVID-19. While it’s a challenge that none of us would really want to face, the fact is, we do believe that it has reinforced the strength of our business strategy. And I believe that it’s positively impacted our team engagement and our One ZB culture. And trust me, we will focus on leveraging our learnings to accelerate ZB’s transformation. At the end of the day, there’s a lot of short-term variables associated with COVID that demand, a level of caution. But make no mistake, we are very optimistic about our path forward. And with that, I’ll turn the call over to Suky to get into more financial details. Suky?
Suky Upadhyay:
Thank you, Bryan, and good morning, everyone. I hope all of you are well. I’d like to reiterate Bryan’s most recent comments that our underlying fundamentals remain strong and our long-term growth profile is compelling. Before jumping into the specifics, I would summarize our second quarter performance as simply being better-than-expected. Revenue was ahead of expectations, driven by fast recovery in most markets, which led to better margins, and we ended the quarter with a strong cash position and ample liquidity. Net sales in the quarter were $1.2 billion, a reported and operational decrease of about 38% from the prior year, driven by the pandemic. We saw the deepest impact on elective procedures and revenue in April, but then saw a rapid recovery with sequential improvement in May and June. While we’re not at normal procedure volumes yet, we are encouraged by the trends since April, as all of our regions and businesses performed better-than-anticipated, since our first quarter call. We will look more closely at our Q2 revenue trends, starting with regional performance and then hit it to our businesses. Moving forward, unless otherwise noted, my commentary will be on a constant currency basis. Beginning with Asia Pacific, the region decreased about 18% in the second quarter versus the same period in the prior year. While China demonstrated sharp V-shaped recovery since April, posting improvement in May and growth in June, most other markets in the region continued to perform below normal run rates. In Japan, our largest market in Asia Pacific, we’ve seen a different profile as that market never got to trough levels experienced in China and was stable in Q2, operating at about 80% of normal run rates. Australia and New Zealand, our third largest market in Asia Pacific observed a sharp decline and a sharp recovery within Q2 and continues to make progress back to normalization. And smaller markets within Asia Pacific continue to struggle with containing the virus and implementing effective policies, and accordingly procedures were down substantially in the second quarter. But, there’s a wide disparity across the sub-markets within the region. But, as expected, a common theme is that we see improvement in the number of elective procedures when the infection rates are stable or declining and where there’s deterrence to physicians and hospitals to make treatment decisions based on the local situation. This holds true for other regions as well. Moving to EMEA, the region decreased 49% in the second quarter. As with other regions, we observed the deepest trough in April and then saw steady improvement through the quarter across all major markets, with the exception of the UK where patients continue to be deferred at very-high rates. Overall, developed markets with EMEA are recovering well. By the end of the second quarter, Germany has started to approach prior year procedure volumes. France, Italy and Spain also improved significantly this quarter and showed the fastest recovery in the region in June. While not yet back to normalized levels, we are encouraged by this progress. Emerging markets in EMEA are improving, but generally continue to lag developed markets in that pace of recovery. Last week, the Americas decreased 40% in the second quarter. As we talked about on our last quarterly call, the COVID-19 impact ramped up materially in mid-March with federal and state governments guidance to defer elective procedures. April was the trough in Americas, but we saw stronger than expected recovery in May and June, as U.S. states reopened. In the U.S., while there are variations week to week, to-date, we have seen approximately 50% of states at or above prior year cases levels, with 80% of states above 90%, when compared to last year. While progress in the U.S. has been good, other markets within the Americas continue to struggle and operate well below normal levels. For example, if you strip out the rest of the Americas from the U.S., you’d see that the U.S. hip and knee growth was actually about 200 to 300 basis points higher than the total Americas number. So clearly, non-U.S. markets in the Americas are still struggling and creating a drag on overall regional performance. Importantly, in the U.S., and in other regions and markets, we’re seeing second waves of steep infection growth. However, we clearly see that the healthcare systems in general are better equipped to address the pandemic, such that we’re not seeing an erosion of elective procedures at the same level as observed in April. For example, in some of the hardest hit counties within Texas, we continue to see procedure volumes at 80% or better prior year volumes, see a similar pattern in other severely hit states. Since the second quarter in July, we’ve seen continued progress and sequential improvement in elective procedure trends. Next, let’s turn to our businesses for Q2. Our global knee business declined 47%. As we talked about last quarter, prior to the pandemic, we saw strong performance in this category, driven by improved operational execution and the continued positive impact of the Persona Revision launch. As Bryan talked about a few minutes ago, ROSA Knee continues to be an important growth driver for us in the near term and the long term. And our ecosystem strategy in the knee business and other categories is really starting to take traction. Our global hip business declined 31% in the second quarter. We continue to see our hip business recover faster than the knee business, pointing to somewhat less elective nature of these procedures. And we continue to see strong traction for our Avenir Complete launch. Sports, extremity and trauma sales declined 29% in Q2. This decline was less pronounced than what we observed in large joints, primarily due to the non-elective nature from trauma. However, the trauma market continued to be pressured due to reduced activity levels related to widespread quarantine, and stay-at-home orders. Dental, spine and CMFT sales declined 37% in the quarter. We’ve seen stronger recovery in spine due to recent new product introductions, including Tether. Also, much like our hip business, spine procedures are seen as less elective by many physicians and patients, primarily due to the pain burden. Finally, our other category was down 44% versus the prior year. Looking beyond Q2, as you know, we withdrew our 2020 full year financial guidance in April due to the uncertainty related to procedure volume uptake. The impact of COVID-19 continues to be fluid and there are a number of market dynamics and variables that we are unable to reliably quantify at this time. As such, we will not be providing updated financial guidance for 2020. But, we do want to share information and insights that may provide shaping of our revenue expectations for the remainder of the year. To give you a sense of the sequential improvement we saw through the second quarter, remember that, on our first quarter call, we noted that, revenues were down about 70% in April across the full business. By the end of the quarter, in June, that decline was only 3.6% down. However, it’s important to note that there was an additional selling day in June 2020 versus June 2019. After adjusting for the additional day in 2020, June was down 13.5%. There was no day rate impact on the full quarter. So, the key takeaway is, if the variables that Bryan described earlier, continue to play out as they are today, we expect the sequential improvement seen in Q2 to also continue through the back half of 2020, but likely at a more modest pace. Now, let’s turn to P&L liquidity. We’ve taken a disciplined and proactive approach to mitigate the earnings impact of the pandemic and enhance our liquidity profile. Results in the quarter were a little bit better than expected since our first port of call and we would expect margins, earnings and cash flow to improve as our revenue profile improves moving forward. In terms of our second quarter results, we reported GAAP diluted loss per share for the quarter of $1 and adjusted diluted earnings per share $0.05. GAAP earnings per share in the second quarter were negative and lower than the prior year, due primarily to the impact of the pandemic, and I will speak to that as part of our adjusted results. Adjusted earnings per share were lower than the prior year, driven by lower revenues and higher cost of goods. Adjusted gross margins were 65.5% for the second quarter, due to less favorable mix and lower fixed costs absorption as a result of decreased production volumes. Adjusted operating expenses were lower due to reduced variable selling expense, the continued early impact of our restructuring program and cost reductions we actioned to deal with the pandemic. As we previously discussed, we were able to flex quickly on COVID-19-related cost reductions in the fourth quarter by leveraging the restructuring programs already in place. Overall, adjusted operating margin for the quarter was 5.7%, substantially lower than the prior year. But again, a bit better than what we expected on our first quarter call. Moving beyond operating margin, net interest expense of $54 million was down versus the prior year, due to debt pay-down in 2019. And our adjusted tax rate was 42.8% in the quarter. Our adjusted tax rate was distorted in the quarter due to discrete tax expenses on a small base of pre-tax income. We do not expect that trend to continue moving forward. Moving to cash and liquidity in the quarter. While free cash flow was negative $145 million, we ended Q2 with higher cash and cash equivalents of $713 million, further strengthening our liquidity position. Also, we continued to maintain $2.5 billion in additional liquidity through our credit facilities, which remain untapped. We believe we’re well-positioned from a capital structure standpoint. In terms of our P&L for the remainder of 2020, we expect that operating expenses will continue to ramp up in the second half of the year when compared to Q2, as we were seeing higher investment levels in R&D and commercial initiatives, in tandem with higher revenues. Interest expense will be a bit higher in the second half of the year versus the first half, driven by the refinancing of debt this year and the additional $1 billion facility put in place. For the adjusted tax rate, a full year rate is expected to be about 100 basis points higher than what we originally guided in February, driven by a change in geographic mix of income due to COVID-19. Overall, we expect that margins, earnings and cash flow will improve as our revenue profile improves. From a longer term perspective, we remain committed to achieving at least 30% operating margin in 2023. As we continue to track well versus our restructuring plans. To summarize, our underlying business and our financial fundamentals remain strong, such that as the market continues to improve, we expect our financial performance will also improve. I continue to be extremely proud of how the ZBT has responded and performed over the past few months. We believe, we’re well-positioned to address the current challenges, as well as accelerate our growth profile over the long term. With that, I’ll turn the call back over to Bryan.
Bryan Hanson:
In closing, it’s clear that the challenge of COVID-19 has been significant to ZB -- to many, obviously. But we’re also very-encouraged by the early days of recovery, and I think really importantly, our ability to rise to that challenge as a team. And I’m going to leave you with three points from today’s call that I hope you take away. The first one is that the Q2 recovery clearly happened faster than expected, and we are encouraged as a result of that. But, we are still cautiously optimistic about the performance in the back half of 2020, just due to the variables associated with the pandemic that we still have to manage through. And two, while our business has been impacted due to COVID-19, our strategic focus and our progress has not been disrupted. And if anything, this challenge has provided us with learnings that are enhancing strategic components of our business. And then, three, we feel very confident about our underlying business strength, our core business strategy and Zimmer Biomet’s ability to drive long-term growth and value. This will take a minute before we close out to Q&A to say thank you to each and every one of our team members around the world. They’re doing just a fantastic job. And your commitment and dedication to ZB enables us to deliver the value to our customers, to our patients and to our shareholders. So, with that, I’m going to turn the call back over to Keri, and I’m looking forward to your questions.
Keri Mattox:
Thanks, Bryan. Before we start the Q&A session, a reminder to please limit yourself to a single question and one follow-up, so that we can get to as many questions as possible during the call. With that, operator, may we have the first question, please?
Operator:
Thank you. Ladies and gentlemen, at this time, we will now begin the question-and-answer session. We’ll take our first question from Rick Wise with Stifel.
Rick Wise:
Bryan, thanks for all the detailed information. Maybe if I could ask even more selfishly, if you could expand a little, give us a little more color on how you’re thinking about -- not just the cadence but the drivers of recovery from here. You highlighted sort of bit. But, when I look at the second quarter numbers and the weighted averages for their market for both [indiscernible] it looks like to me, Zimmer did outperform, declined less than the group averages both worldwide and U.S. specifically. Maybe help us better understand specifically the drivers. Is it execution, your execution focus, your products for keens, ROSA, is it all the above? Where do you think the emphasis points? And just bottom line of this, what’s the setup then as we look at ‘21 beyond? How quickly can we get to that mid-single-digit absolutely possible kind of growth? Thanks so much, Bryan.
Bryan Hanson:
Thanks, Rick. That was a lot of questions in there, man. So, I’m going to try to tackle this in maybe in two categories. One, I think, I’ll just deal from -- your question is, what’s kind of driving the underlying strength of the business, and I’ll give a little more color on that versus what I had in my prepared remarks. And maybe the second piece of it is just broadly speaking about the recovery from COVID, just any deeper thinking there. And then, maybe I’ll pass it over to Suky to get into some detail on -- maybe a little more detail even on how we’re looking June, July, and what we think that’s going to mean on a go forward basis. But I would say, first of all, the things that we can control right now are extremely important to stay disciplined on. And so, I truly do believe, that’s the reason why our strategy is being executed as flawlessly as it is. And that’s really important to us. Some of the major things that are alarming to happen is, number one, we don’t have the supply issues that we used to have. And you remember, what I used to talk about this. There was going to be post-traumatic stress disorder from the commercial organization in this category, and they wouldn’t believe us for a while that it was actually solved, they do now. They’re not wasting time anymore on this. They are fully focused on driving new business. That’s a big part of it. The second piece to that is you’ve got to have new products. You got to have innovation. Having supply is just basic hygiene. You got to move past that and actually bring new products to the table because that’s the lifeblood of a commercial organization. And that’s what we’re giving them. Giving them new technologies that I already talked about, and they’re delivering in those areas, sticking to the commitments that we had. The other big one is that we have dramatically changed the engagement between the senior management of this organization and our commercial organization. There was distrust there before that does not exist anymore. And the combination of those things, I would tell you, we’ve got a swagger back in the ZB commercial organization. And that swagger goes a long way when you’re talking about getting out in the field and getting things done. On top of that, we’ve also got to change compensation program that’s more focused on growth. It’s biased to paying people to grow and less biased to those that don’t. And we also have operating mechanisms with discipline to hold people accountable for delivering that we did not have before. So, those are the things that the things we can control that are driving positive momentum in the business and will continue to drive positive momentum in the business. Outside of that, when we talk about COVID, I would stick with the variables that I mentioned before. And when we think about those variables, that idea of the headwinds being patient fear and recurrence of the virus, those are big variables, and they’re going to be unpredictable, unfortunately. There’s no way to predict what they’re going to do in the future. That’s why that volatility exists and we’re not giving specific guidance moving forward. But, I think sometimes the best way to try to get a sense for what’s going to happen is look at what’s happening right now, because we are seeing the resurgence of the virus in many areas. And as a result of what we’re learning in those areas that would give us some feel for what would happen on a go forward basis. So, maybe with that, I’ll just kind of flip it to Suky, to be able to talk more specifically about what we’re seeing right now. And maybe that’ll give you some color on what we think is going to happen going forward.
Suky Upadhyay:
Great. Thanks, Bryan. And thanks for the question, Rick. So, we clearly saw really good performance and improvement through the back end of Q2. As I talked about June exits on a day rate basis, were down 13.5%. That compares to being down 70%, if you recall back in April. So, clearly a pretty steep V-shaped recovery in the quarter. Now, in spite of that what we saw was Asia Pacific was about overall Company average plus or minus. Some of the areas we’re really watching in Asia Pacific, our second and third largest market, China and Asia -- sorry, Australia and New Zealand, performing really well, getting very close or at normal wise run rates. The other big watch-out for us is Japan, which continues to operate in sort of that 80% to 90% range, and that is our largest market. So, we’re keeping a close watch on the recovery in that particular market. And, of course, we’re really struggling in a lot of smaller markets in Southeast Asia. As we turn to EMEA relative to that overall company average of down 13.5%, EMEA was down significantly more than that. And that’s simply because the recovery just started later in the quarter for that particular region. Seeing really good uptake with our larger markets, but we’ve got to keep our eyes on the UK, which continues to defer at a very high rate and emerging markets is lacking. That was already a pretty lumpy business with tendering. COVID has just made it that much more difficult to predict the trend. But again, recovery in the biggest markets within EMEA is really good in the back end of the quarter. Then, you turn to the Americas, and this is probably where we saw the biggest and sharpest return in the second quarter, and as Bryan talked about, a little bit ahead of our expectations. Within the U.S., we’re seeing really good traction. We do continue to get hit in some pretty hard states, as we talked about, Florida, Texas, Arizona, but nothing compared to the first wave. Those particular markets are operating in the 80% to 90% range. And what we’re seeing is some of the states that have recovered a little bit later, like New York, New Jersey, some of the Northeastern states, they’re operating close to 100 or maybe even some aspects or some parts going above 100. So, you’re seeing that offset, some of the harder hit states. So again, the U.S. is overall trending pretty well, but we’re keeping our eyes on that second surge. I think, within America’s however, we’re seeing a pretty big headwind from Canada and more importantly from Latin America, as those particular markets continue to struggle. And so, try and kind of emphasize the headwind that we’re getting from those markets, if you actually looked at our U.S. knee number for instance, there was about 200 basis-point headwind by including total Americas. And so, if you excluded Americas, our U.S. knee number was about down 44.7%. So, again, about 200 basis points better, and that’s even with a tough comp on ROSA. And then, our U.S. hip business had a headwind of about 300 basis points, when you include the rest of Americas. And so, clearly, the rest of the Americas is a piece of kind of masking, even better performance in the U.S. So, as we think about things going forward in July, sequentially, things got better than where June was. And so, that’s good second leading indicator there. However, July was still down versus prior year, okay? So, than June, but still down. And when you think of the composition of the reasons I talked about, it’s very similar to what we saw in June. Americas a little bit better than the overall company average in July, APAC kind of in line and EMEA, a little bit behind. So, hopefully, that gives you a little bit more color. Sorry for the long answer, but I know that’s a question on a lot of your minds. So, we just wanted to address it proactively.
Operator:
We’ll take our next question from David Lewis with Morgan Stanley.
David Lewis:
Just two for me. One, Bryan or Suky, just on recovery. Bryan, you mentioned this $700 million, $800 million backlog. I just sort of wonder how much of that has been worked out. And I’m assuming this dynamic of scheduled versus rescheduled patients is why you said recovery is less steep into sort of the back half. And just maybe talk about that backlog and whether you think you can get back to growth in the fourth quarter. And then, I had a quick follow-up on ROSA.
Bryan Hanson:
So, what I would say is that $700 million or $800 million is still out there. So, I would say, that’s the amount of backlog that is still out for future revenue, and none of that is I’m counting as being already captured. I do believe that when you think about the backlog, again, you’ve got to separate it into two different categories. First category would be those patients that were deferred in the very beginning. So, you absolutely know they’re deferred patients. And the other portion of that backlog are those -- I’m just going to call them category 2 patients, which are kind of just building right now and will continue to build until we get back to market growth. And so, that $700 million to $800 million will be future revenue for us. My sense is that, first category of patients, those that were deferred initially will likely be completely run through, by the time we get to the end of 2020, or most of them will. But you’re still going to have a pretty significant backlog left for 2021. I would say, the way you can calculate that is, when you look at your overall market growth delta between what we actually did in 2020 versus the market growth, whatever that delta is, in those procedures that are elective and also are connected to progressive diseases, a large majority of those patients will come back into the funnel. So, if you just look at that delta. Let’s say, you had 100 procedures or less than typical market, you could take probably 80% of those or 80 procedures and say that’s my backlog that will come into 2021. So, that’s kind of the way I’m thinking about it. The challenge is that you have these big variables that are still moving out there around patient fear and the resurgence of the virus. So, it’s difficult to say that the backlog coming back in is going to give us that tailwind that we want without the negative impacts of those two variables. But, what I’ll say again is, if we can move to the point where we have a valid vaccine or an effective treatment, that takes those two variables off the table. And then, you’ve got the backlog as a tailwind, which should be significant for us. And so, you could see a pathway, I guess what I’m saying. If things stay about the same, as you come into a vaccine, renew or mitigate those two negative variables, a very strong growth in 2021, the challenge is, those variables -- and I’m saying that need to go away are pretty significant, and we just don’t know if it’s going to happen or not. But certainly, you could see a pathway, just given again that backlog volume of strong growth in the back half in 2021. It just depends on how those other two variables play out.
David Lewis:
Okay. Just a follow-up there. It’s hard to be definitive on fourth quarter growth I think is what I’m hearing, that’s what in your comment there. And then, I’ll ask my second question as well. Just on ROSA, Bryan, obviously that number is kind of materially how the way the Street was thinking on ROSA placements and thanks for the detail. So, did placements accelerate here into the second quarter? I’m sort of curious, has the selling structure around this placement has changed at all as well as usage based agreements? And if you could just give us some sense from a competitive account perspective, where the systems are being placed, what percent are the traditional Zimmer majority accounts versus the competitive share capture? Thanks so much.
Bryan Hanson:
Yes, absolutely. So, it’s a combination. I would tell you that we are absolutely looking at both competitive as well as friends and family. So, even though the original strategy was to focus just on friends and family, because we’ve got a huge opportunity just given the amount of implant percentages that we have in the market, we are definitely seeing competitive situations and we’re winning in those areas. When I think about ROSA in general, I would just say that we continue to see sequential improvement in placements. And believe it or not, even in Q2 there was no disruption in that sequential improvement. That just speaks to the maturity of our commercial organization, the majority of the pipeline of potential customers that we have, and our ability to translate that pipeline into actual sales. And I would expect that to continue. I would say that more recently, as I referenced before, the mix in the way that we’re placing these is different. Most customers previously wanted to buy. And now, we’re seeing a shift to this opportunity to acquire the technology through volume commitments, which in reality, as I stated before, is actually the preferred method of placement for us. I would much rather have that annuity revenue that is linking me to the customer for a longer period of time than having upfront capital acquisition. And that’s what Suky referenced before. If you look in Q2, you look at our knee performance in the U.S., for instance, we actually had a headwind associated with robotics versus last year, was actually a slight drag to our growth rate in knees, because we had sold more last year than we did this quarter. So, again, I think, again, the pipeline is strong, excited about the product line and we’re seeing continued sequential improvement quarter-over-quarter.
Operator:
We’ll go next to Matthew O’Brien with Piper Sandler.
Matthew O’Brien:
Just a follow-up on the ROSA side of things. When I look at, Bryan, the number that you’re thinking that you’re going to have in the field this year, that’s around 200 compared to how many you had out that you’re placing this year versus what you had out last year. So that’s pretty similar to what the market leader did as far as placements last year in this category. So, what I’m trying to figure out is kind of to David’s question, what’s the split between friends and family versus competitive accounts? And are you seeing a building improvement on the competitive account side, as we speak or kind of as you’re looking forward? And I do have a follow-up.
Bryan Hanson:
Yes. So, I would say, without giving specifics. I would say that the competitive accounts are probably greater than 50% of the placements. Again, that’s even increasing as we’re finding more customers looking at this opportunity to bring in the system, based on volume commitments. So almost by default, to be able to get a system placed like that, you’ve got to have a competitive situation, so that they can commit that volume to be able to get the robotic system placed. So I’d say, it’s north of 50% and it looks better right now because of the placement strategy shift, not from us, but from our customers.
Matthew O’Brien:
And then, on the revision side, and I didn’t hear much on cementless, I may have missed it. But, when I look back historically, you’ve lost, I think some somewhere around 300, 400 basis points a share on the revision side, cementless, as they incurred primaries in total, I think it was a couple hundred basis points. So, there’s a lot of users out there that are familiar with Zimmer. Are those the ones are getting back the quickest right now or even going into new accounts that you hadn’t really been present before? Because of those assistance, because of ROSA, and you feel comfortable. Again, I understand there’s some variability about outperforming the knee market, broadly speaking over the next several years?
Bryan Hanson:
Yes. I’d say, on the cementless, we continue to gain traction. I think we’re -- our product is being well received. And as we see more penetration of robotics in our accounts, you’re going to see by the very nature of robotics and the capability to use cementless more comfortably, you’re going to see a continued increase in the cementless percentage of our business. What I’d say on the revision side, it is absolutely a tip of the spear product. And we’re clearly going into accounts that have been using Persona and have not been able to use our revision system, and we’re picking up those accounts. Those are the obvious ones. But, it’s such a good revision said that we’re getting competitive surgeons that want to move to this. And as a result of that, we’ll get primary pull-through as well. So as much as that’s an exciting product, when I talked about close to $100 million opportunity there for this year, that’s not including the pull-through that we would get when we have competitive conversions on the primary need.
Operator:
Thank you. We’ll take our next question from Robbie Marcus with JP Morgan.
Robbie Marcus:
Great. Thanks for taking the question. Maybe just a quick clarification. In the script, you said that at the end of June, the decline was only 3.6%, but adjusted for selling days, it was down 13.5%. Is the just more the exit rate of June versus the full month or is there something else going on there?
Bryan Hanson:
Hey, Robbie. That was the full month of June, as opposed to the final weeks.
Robbie Marcus:
Got it. Okay. And then, maybe, Bryan, it sounds like -- if I go back to dental and maybe spine, when times are tough, it’s easier to revisit different parts of the business that might not be some of your top performers or have the best growth rates going forward. How are you thinking about some of your businesses that have been underperforming lately and how are you thinking about potentially improving or monetizing them in this environment where there are a lot of willing buyers out there with recently raised capital? Thanks.
Bryan Hanson:
Yes. So, as -- the first focus is, as I said in the prepared remarks, we have certain businesses and sub businesses that will be the primary areas of investment. But, what I’ll make very clear is that does not mean that the businesses outside of that are not important to us, and it does not mean that I don’t expect results in those businesses. And they are getting investment, just not the same level. So, I fully expect my businesses in dental, spine, CMFT that I did not name as areas of extreme focus, I expect them with the investments they’re getting to perform. And if I think about spine specifically, we’ve got an opportunity there to do that. Now, it’s got to happen in a few different ways. We’ve had a lot of flux in our commercial organization that is now stable. Well, that stable commercial organization has to turn into a productive commercial organization. We have Mobi-C, which is the best cervical disc in the marketplace. We have a good traction to that. We have -- that as a tip of the spear product that we have not been taking advantage of and I need to see that. And we have Tether that Suky mentioned in the prepared remarks, that is an innovative change that dramatically changes the patient experience in scoliosis patients. That is an exciting product that we need to be able to use. And we have ROSA. So, we’ve got the components of success in spine with the investment level that we have. I need to see it transpire in the same way that we saw with the similar investment level, dental perform. And so, I just want to make sure that it’s clear that just because I don’t have those businesses as one of the primary growth drivers of the organization, it does not mean they’re not important to us, and it does not mean that we’re not going to continue to invest in some level, and it does not mean that I don’t expect results.
Operator:
We’ll take our next question from Pito Chickering with Deutsche Bank.
Pito Chickering:
Good morning, guys, and thanks for taking my questions. The first one is I wanted to follow up on David’s question on $700 million to $800 million of backlog. I understand that the backlog is out there. But, any chance you can give us the color as to procedures you guys saw in June or July, where the split between deferred procedures that happened to versus newly-diagnosed cases that were done. I’m just trying to understand the price of recovery and the sustainability of that recovery.
Bryan Hanson:
Yes. What I would tell you is that, although we do collect data on this, it’s becoming more muddled. And the reason why is because you’ve got a complete mixture now of what is a deferred patient. If you need look at just those folks that we knew were deferred, then I can get a sense for how many of those are coming through. But, when I look at truly this growing backlog of deferred patients, it’s difficult to know which one of those is a new versus a deferred that’s created as a result of COVID. So, it is becoming muddled. I think, the easiest way to look at it again is to go back to in those areas that we have, large joints, shoulder, those areas that are elective, but are connected to a progressive disease. I would just look at the delta in market growth and just know that 80-plus-percent of those patients are eventually going to come back in. And I’d stop worrying as much about what is a deferred patient, what is a new patient. I just look at the total deficiency to market and know that history shows those patients eventually come back in the funnel at a pretty high rate. That’s the way we’re thinking about it. I think, spending too much time now trying to understand the deferred to new patient mix is just -- it’s too muddled, it’s too challenging to understand what that actually means.
Pito Chickering:
Okay. A follow-up there. August, is typically a pretty slim month, surgeons take vacations. Any color from your sales force about how do you see surge in demand in August? And do you think that docs are motivated to work through their backlog and provide big growth and easy comps?
Bryan Hanson:
I’d tell you, it’s interesting because particularly in Europe, you see August being a challenging month, because a lot of holidays. But, even in parts of Spain what we’re hearing is that people are going to take fewer weeks of vacation to be able to deal with some of the backlog. And that is an area that you typically don’t hear, that’s at a response. And it’s the same pretty much around the world. The general feedback that we’re getting from service in hospitals is they’re going to take fewer days of vacation to try to work through the backlog. Everyone recognizes there’s a bolus of patients that need to get served. And my general sense is that you’re going to see people try to work through that backlog. The only time that you would see maybe no -- something that would look different than that is in the public health system in Europe. But, we just don’t have the same incentive to be able to work through it, and potentially sometimes even the budget to be able to work through it. But generally speaking, I’m getting very good feedback on the desire to work through the summer, work through this backlog and take care of patients.
Operator:
We’ll take our next question from Matt Taylor with UBS.
Matt Taylor:
So, it’s really interesting to hear the color on ROSA system placements and utilization there. And around the focus on utilization perspective, and I’m going to much about that. You saw pretty strong use despite the pandemic conditions. And I guess, I was hoping, you could provide some outlook for that and maybe benchmark it versus other systems that are out there. Where do you think utilization could go in the coming quarters for these ROSA systems in that maturity?
Bryan Hanson:
My sense is, we could see continued increases of utilization per system. And again, remember, go back to the tenants that we had in place as we design the system. One of the primary things we focused on was to make sure that it did not disrupt the surgical flow and it did not change the time to do a procedure. And that’s what we’re finding actually happening. So, the good news on that is it -- the surgeon can digest it more easily, because it doesn’t change what they do as much. It just makes it better. But, what it also allows is more surgical volume, right, using robotics, because we don’t slow the procedure down. So, I would expect, as people get more comfortable with it, and they see the difference in outcome for patients that use robotics versus not use robotics, I would expect it to continue to go up per unit. And then, obviously, as we place more units, I see those procedural lines increasing pretty quickly.
Matt Taylor:
And another follow-up, people have alluded to the deposits prior to it and being able to push that forward in a tough environment. Do you think that hospitals are benefiting from stimulus or how have they been able to continue to make the kind of capital investments or other arrangements despite the disruption and pressure on the budget?
Bryan Hanson:
Yes. I really do. We were very concerned out of the gate that we wouldn’t be getting paid by hospitals, let alone, seeing this kind of traction. And I think the stimulus did help. I think it took the pressure off and it made hospitals feel more confident and comfortable to be able to continue to move their strategy forward. And so, our receivables, for instance, never really got significantly damaged during all this, because I think they felt comfortable with that liquidity. And we really haven’t seen much of a change in demand, I mean, initially, for sure. I mean, people didn’t know what was going on and they didn’t know for sure what was going to happen. So, there was a month, period of time where there was a little bit of chaos. But as you worked through that and people felt more confident and comfortable in liquidity, things got back to normal pretty quick.
Matt Taylor:
Thanks a lot.
Bryan Hanson:
I said normal. Clearly that’s a new normal, not actual normal.
Keri Mattox:
Thanks. Katie, I think we have time for one last question.
Operator:
Thank you. We’ll go next to Richard Newitter with SVB Leerink.
Richard Newitter:
Hi. Thanks for taking the question. Maybe just on ROSA. I think, one of your competitors, the leader in the markets, and they saw high proportion of placements, better than expected placement into ASC setting. I’m just curious if you could comment at all on whether you might have been seeing ROSA is getting placement with ASC? And within the context of that question, how Zimmer maybe has positioned to benefit from -- or to feel an impact from accelerated trend through the ASC setting more broadly? Thank you.
Bryan Hanson:
Yes. I mean, clearly, you would see a natural desire from patients, I would think to be in a non-hospital setting, just given the issues around virus fear. So, it’s not surprising to me that we’re seeing some additional pace moving to the ASC from a procedure volume standpoint. And we are absolutely ensuring that commercially we’re going to be ready for that. We’ve already focused on it obviously, but we’re going to put that on steroids now. And I would say from a robotics standpoint, it plays quite well for us. Remember that you do not have to have a CT scan to be able to use a robotic system for ROSA and that helps us quite a bit in the ASC setting. And also, we’ll go back to this idea of throughput, these are business people in ASC setting. Volume is very important to them. They have to get the throughput of patients to be able to get the same reimbursement and to be able to get the business dynamics that they want. And that ability to use our system without a change in time really matters to them. And so, again, I think it bodes well for us, quite frankly. And I’m very happy to hear that our competitor also saw surge in robotic placements. It tells you that the demand for robotics is real and the penetration of robotics is still very-low. And that to me is an opportunity for everyone who has a real robotics solution.
Richard Newitter:
Got it. And then, Bryan, just for my follow-up. I’m curious, on the M&A front, I appreciate you are doing the start-up, smaller or tuck-in. I’m just curious, in the wake of COVID, has that in any way changed maybe where you might be initially focused on the types of acquisitions or anything that now just on a go-forward basis might fit more strategically into the business, as you look forward? Thanks.
Bryan Hanson:
Yes. Let me -- I’ll answer that very specifically. But, let me pull up this for a second, because I think it’s helpful context, because we are in a phase now where I feel much more confident and comfortable moving into active portfolio management, and we will absolutely move in that direction. But, it was important to get there, because I kind of think about this positioning, this Company transforming this company for success in three phases. The first phase was kind of obvious to everybody. We had to triage patients, right? We had real problems around culture, mission, connection just wasn’t there, we didn’t have the top level talent that we needed to be able to move the business forward, we had supply issues, quality issues, we had a DoJ monitor in the house. And so, we had all these things that we had to fix. And I’m not saying that we’re not going to continue to focus in those areas, because it’s going to evolve. But that was kind of Phase 1. We had to fix those things. Phase 2 is more around shifting to innovation, had to get new products out in the market, we had to be able to crystallize our strategy, and our focus in our strategic pillars, and then make sure we had the right organizational structure to drive that. So, all those things kind of happen in Phase 2, and we’ve got to have the operating mechanisms to make sure that we deliver on those things. Phase 3 really comes around portfolio transformation. And that’s exactly what we’re going to be focused on. And yes, I would say that the insights that we’re getting from COVID, because we’re learning every day, and we are applying those insights into the way that we’re going to manage our strategy, didn’t fundamentally change the strategy, but it’s augmenting the strategy. And I would say that we will have a focus as we look for diversification, and being able to get better penetration in the ASC to be able to continue to focus in those subcategories and set that we know are going to be attractive, and to be able to think about acquisitions now, to get us away from our dependence on elective procedures. So, there’s a lot of different sectors that we’re considering now in the way that we’re going to look at potential opportunities for acquisition. I would still say, as I said before, there are going to be smaller tuck-ins for now, because our access to liquidity isn’t quite the same, just given what’s going on right now. And we want to make sure that we stay investment grade, but we are clearly focused right now on active portfolio management.
Operator:
That will conclude our question-and-answer session. I’d like to turn the call back over to Keri Mattox for any additional closing remarks.
Keri Mattox:
Thanks, Katie. And thank you all again for joining us this morning. If you have questions, please do not hesitate to reach out to the IR team. You can also find a replay of the call on our website, zimmerbiomet.com. Thanks so much and have a great day.
Operator:
Thank you again for participating in today’s conference call. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet First Quarter 2020 Earnings Conference Call. [Operator Instructions]. I would now like to turn the conference over to Keri Mattox, Senior Vice President, Investor Relations, and Chief Communications Officer. Please go ahead.
Keri Mattox:
Thank you, Operator, and good morning, everyone. I hope you are all well and safe. Welcome to Zimmer Biomet's First Quarter 2020 Earnings Conference Call. Joining me virtually today are Bryan Hanson, our President and CEO; and CFO, Suky Upadhyay. Before we get started, I'd like to remind you that we recently made slight changes to our revenue reporting format as discussed on our fourth quarter call. These changes are designed to further align with the company's recent reorganization and are used in our first quarter results. Reconciliations are available on our website. Additionally, our comments during this call will include forward-looking statements. Actual results may vary materially from those indicated by the forward-looking statements due to a variety of risks and uncertainties. Please note, we assume no obligation to update these forward-looking statements even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties in addition to the inherent limitations of such forward-looking statements. Additionally, the discussions on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within the earnings release found on our website at zimmerbiomet.com. With that, I will now turn the call over to Bryan. Bryan?
Bryan Hanson:
Thanks, Keri. And I think everybody knows that we're in different locations right now, so I'll just apologize upfront for any of the awkward handoffs that we have between each other for this earnings call and any bad cellphone connection and/or dogs barking in the background. I'm sure everybody's used to that by now. I just also want to say before I get started that I certainly hope that you and your families are healthy and safe and trying to get used to this unusual environment that we're working in and living in right now. I can tell you that I've been home more consecutive days with my family than I have I'm pretty sure in the last 20 years, and I know for sure that they cannot wait for this to be over because they want me to get out of the house. So again, hopefully, you're managing through this as best as possible, certainly gives us an opportunity to learn things about ourselves that we did not know before and our families. Given the fact that it is so unprecedented when we think about COVID-19 and really just thinking through it, there really is no proxy that you can look back on that would give you the pathway forward as a result of looking at that historic view. There's nothing that compares to this, I mean, when have we ever seen a global pandemic shut basically the world down. And as a result of the significance of it, obviously, we want to make sure that we spend a lot of time talking about it today on the earnings call. I'll spend time walking through it. Suky will spend time giving his view of it. We'll let you know how it's impacting ZB, what we can give you relative to what we think will happen in the future from here. But the fact is there's going to be a lot of information moving back and forth, particularly in the Q&A, I'm sure. And I just want to make sure that you walk away from the call with at least these 5 key points because at the end of the day, I truly do believe these will be the most significant and meaningful points that we have throughout the call. And the first one is really that Zimmer Biomet, myself included, have been very focused on ensuring that our 1 priority through all of this has been the safety of our team members. And I'll talk more about this in a minute, but I'm very happy with the momentum that we've picked up here very early to make sure that our team members are safe and the amount of energy that we've put behind this. The second thing is that we have a high level of confidence that we have adequate liquidity and financial flexibility to manage through this storm. I would tell you that I'm very proud of the work that Suky and his team did to make sure that we backstopped the organization aggressively right out of the gate. And we do have a high level of confidence in our liquidity and financial flexibility as a result. Number three, we also have a very high level of confidence in the recovery. I'm very sure that a majority of these patients will come back into the funnel. The biggest variable right now is just the timing of that. But just know that we have a high level of confidence the recovery will happen, and many, many of the patients that are being deferred now will come back in the funnel. The fourth thing is that we will continue as an organization to invest in our key strategic areas, in research and development and commercial projects. This will not deter us from continuing to double down in those key areas, and I'll talk more about that in a minute. It doesn't mean that we won't save money because we have aggressively, but we will be committed to spending money in these key strategic areas. And the fifth thing is that we are, just given the work we've done over the last 2 years to reshape the company, we are better prepared right now to deal with this challenge than we would have if it was 2 years ago. As a matter of fact, we feel confident that given that reshaping of the company and the position we're in, we cannot only come through COVID-19. We will come through in a better position as a result of the work that we have done. So really, those are the 5 things. Safety is our 1 priority. We feel confident in the liquidity and financial flexibility of the company. We have confidence in the recovery. We will continue to invest in key strategic areas, and we are very confident we will come out the other end of COVID-19 in a better position than when we started. Okay. So let's start with safety, and I'll just give you an overview of why I feel so confident here. Interestingly enough, last year, as a part of a broader risk mitigation kind of a planning process that we are going through, crisis management planning process, we actually did put together a comprehensive global pandemic plan. I know it sounds inconceivable that we did this literally months before the pandemic occurred, but we did have it in place. And as a result of that, to the extent possible, we were as ready for COVID-19 as you can be. And we mobilized that plan and the multiple work streams right away, very early on in January, actually. And that's been, from my perspective, a significant game changer for us. And I also think it's our ongoing transformation of ZB that has really been key in this whole process. We already had the means to tackle this because we had a stronger team. We've been able to put a stronger team together over the reshaping over the last 2 years. We have a very active and engaged business right now, and we have a very supportive culture. All those things are paramount to being able to get through a challenge like this, and we move to put new policies in place even before the COVID-19 reached pandemic status. Very early on in the process, we began to shift immediately to work-from-home policies, no travel policies. We did not allow visitors in our distribution sites or our manufacturing facilities. We didn't want visitors entering the sites where our essential workers were. That just doesn't make any sense, right? We want to keep them as isolated as possible, and we did that right out of the gate. We had no large meetings, and we had broader social distancing practices in those sites that we are continuing to work. And so again, I really do think that we moved aggressively and took a very proactive stance because we had the road map already laid out through that planning process. I also want to just thank all of our team members and especially our manufacturing, distribution and commercial teams, who have gone just truly above and beyond during this challenging time. We still have team members who have been out in the hospitals every day. They're still there, making sure that the health care professionals that we have that are out there doing procedures still have what they need to be successful in those surgeries. And it's just impressive, really, truly on the front line to make sure that we move patient care forward. Our team has also adhered to new safety protocols and has made changes to our sites and production lines and where possible, obviously, making sure that we are doing the work that we do in a safe and effective manner given the guidelines that we have right now for COVID-19. They've also managed temporary facility shutdowns to basically proactively modulate production where we need. And all the while, they've done all of this without disrupting our overall supply chain. So needless to say, I'm really proud of how the ZB team has taken safety so seriously out of the gate and has worked to achieve goals to keep not just our team members safe, but also our customers, our partners and our patients safe as well. Okay. Moving on to number two and our confidence around the adequate liquidity for the business and financial flexibility. I would tell you just right out of the gate as we saw the challenges associated -- disruption associated with COVID-19, we took very aggressive measures to contain cost and also, obviously, to support the liquidity of the company. One of the first things that we focused on was making sure that we refinanced our $1.5 billion of debt that came due on April 1 of this year. And then Suky and team went to renegotiating our $1.5 billion revolver and then shortly after that secured an additional $1 billion credit facility as an additional backstop. And so again, just kudos to Suky and his team to make sure they got right out ahead of this and made sure that we had that financial flexibility and liquidity strength in the organization. Additionally, we've continued to execute on our previously announced restructuring program. As you may remember, this program was focused on streamlining our structure and just driving efficiency throughout the organization with the ultimate intent to allow for margin expansion over time, which we committed to, while also allowing for investment for growth. Really, the only way that we could have both those things happen in tandem was to be able to put this restructuring plan in place. And actually, having the restructuring plan and the working group in place to move it forward actually helped us to quickly pivot and aggressively cut costs as a result of the COVID-19 challenges using the very work streams and really the mindset that we had in place for this program. We've also modulated the schedules and the output across our manufacturing facilities, keeping an eye on cash consumption with inventory while also positioning the business for business continuity, right? We need to make sure that we have the inventory that is needed today. And also, we have the inventory for the recovery when it comes. And finally, we implemented temporary base pay reductions for all of our salaried team members of about 20%. And we did 25% cuts for executive teams and then up to 100% reductions to the annual retainer of our Board of Directors. And as you probably have heard, I've taken personally 100% reduction in my pay during this period. Okay. Moving on to 3, our confidence in the recovery. What I'd tell you just first and foremost, the momentum that we had coming out of 2019 absolutely carried into the early part of the first quarter, obviously, pre COVID-19. But we were performing at or above our expectations pretty much across all businesses and regions. Now there's no doubt that the pandemic has absolutely changed the landscape for everyone. But for ZB specifically, it has significantly impacted our business, probably more than most, just given our dependence on elective procedures. We have 80-plus percent of our global revenue that comes from elective procedures. That's the bad news. Now the good news is, as I said, our business was strong before the pandemic. And the good news is, we do believe that these patients will, in fact, come back into the funnel. The fact is you can certainly delay these procedures. There's no question about that. But the critical and really often life-changing nature of a knee procedure, a hip procedure, back surgery or other bone and joint procedures make us confident that these patients will ultimately return to the health care system. And the fact is we've seen that. It's not an exact proxy, but we have seen when natural disasters occur or other market disruptions occur, and patients get deferred, they do, in fact, come back, the large majority of those do come back into the funnel. Now this is obviously significantly different than what we've seen in the past just given the volume of deferred procedures. There are other variables that make it harder to determine when they're going to come back. The fact is even OR capacity will have to be something that we consider in the short term with bringing these patients back, just given the number of patients. We're going to have to think about the access to PPE and/or testing kits. And we're also going to have to think about the psychological viewpoint of a patient on when they're ready to come back. But I can tell you right now is we've done our own analysis, and we've done an extensive outreach to our customers. The one consistency is that everyone does believe the majority of these patients will come back. The question just becomes over when that's going to happen. Based on our modeling right now and really our Q1 performance and our April performance, what we would say, if we're trying to put some color to this, is that, clearly, Q2 is going to be the most challenging quarter, and April as a month will be the most difficult month. We truly do believe after April, we're going to see sequential improvement on a month-to-month basis and on a quarterly basis until we get back to normal. But we definitely see April as the most challenging month and then sequential improvement from there. Okay. Moving on to 4. As I said, we're going to continue to invest in a dedicated and disciplined way in key R&D and commercial projects. We're highly focused on the high-priority, high-growth areas of our business, and we're making investments to continue to drive innovation in those areas. The fact is when we look at ROSA and/or any other robotics-related initiatives that we have, these are key priorities. And our investment, if anything, will accelerate right now and certainly the focus on these projects. And we're going to continue to build out our dedicated specialty sales teams and other high-value commercial programs. These things will not stop during this time. In terms of supporting innovative commercial initiatives, we've launched recently the mymobility LE, which is a change to mymobility to make it more limited addition, lower cost version of mymobility, but really built for rapid deployment to help customers and patients respond to the needs of the COVID environment right now. mymobility LE and our exclusive partnership with Apple can be used by surgeons and care teams to actively, but importantly, virtually, support and guide patients preparing for the procedure and recovering from the procedure at home. This is an innovative and really alternative solution to continue delivering pre and post op care and reduce unnecessary in-office and hospital visits. It's perfect for this particular time and providing all the while through this mechanism, mymobility LE, providing real-time data on patient's progress so that surgeons know how that patient is doing. It offers education. It offers video-guided exercises for rehab programs to be able to do that at home, to not have to have that personal contact with rehabilitation. And it provides direct video, picture and text-based messaging right to the patient, again allowing that patient and surgeon connection to be there, but also allowing that to happen with the new social distancing policies that are in place. Another great commercial initiative that was put into place was to make sure that when AAOS conference was canceled in March that we immediately got to putting together a virtual, kind of a virtual reality AAOS experience, where health care partners can actually come in to the booth, again, virtually. But through that virtual experience, they can learn about the products that we would have shown at AAOS. They can talk directly with our commercial teams through that virtual experience, and they can even sign up for the trainings that would have been there or other trainings that we're doing online as well. And I can tell you that out of the gate, this has been very well received by our surgeon partners. We've had over 7,500 site visits in the first 2 weeks alone. So again, we're going to continue to stay focused on investing in those areas that are important and strategic to the organization, and we're going to make sure that we continue to bring innovations that matter right now during the pandemic. And finally, moving on to the fifth takeaway. We truly do believe that the work we've done over the past 2 years to reposition the company for success absolutely better positions us to be able to not just get through COVID-19, but to be able to emerge on the other side in a better position than when we started it. This is clearly a challenging time that will test, I think it's obvious, even the best teams and the most innovative companies. And what I know for sure is that over the past 2 years, we have made real progress in transforming our culture, evolving our business strategy, improving our financial performance, and we have vastly improved our manufacturing supply and inventory management. Our base business is strong, and we have a talented and dedicated global team that positions us very well for this challenge. We believe that this progress and, truthfully, our proactive stance and our financial stability also give us key competitive advantages right now during this challenging time that could open up new opportunities not just to drive innovation, but also grow our business and our share position in the near term. And with that, I'm going to turn the call over to Suky to get into more financial details.
Suketu Upadhyay:
Thank you, Bryan, and good morning, everyone. I hope that you and those close to you are healthy and remain safe. I'd like to start by saying that our underlying fundamentals remain strong. Recall that in February, we announced a strong close to 2019 with top line results ahead of expectations, leveraged earnings, robust cash generation and continued deleveraging of our balance sheet. While COVID-19 has had and will continue to have a significant unfavorable impact in the near term, we remain confident in our ability to navigate these challenges and to return to a positive trend over time. Let me turn to first quarter revenues. Net sales were just under $1.8 billion, a reported decrease of 9.7% from the prior year and an operational decrease of 8.9%, excluding the impact of foreign currency changes. Moving forward, unless otherwise noted, my commentary will be on a constant currency basis. Prior to COVID-19 reaching global scale late in the first quarter, most of our businesses and markets were trending at or ahead of expectations. However, the deferral of elective procedures as a result of hospitals redeploying resources to COVID-19 had a meaningful negative impact on our first quarter performance. Across ZB, this impact became most pronounced in mid- to late March. Again, revenues for the first quarter were down 8.9% versus the prior year and down approximately 60% in the last 2 weeks of March. That trend extended into the first part of Q2, with April revenues down about 70% versus the prior year as we observe the impact of the pandemic intensify in submarkets. I'll break down the overall revenue trends I just mentioned, starting with regional performance and then move to our businesses. Beginning with Asia Pacific, the region decreased 9.5% in the quarter. We began to see procedure deferrals in early February at varying levels across the region and at varying times during the quarter. Since it was one of our first markets to be impacted, I'll provide more color on China, which represents about 20% to 25% of the region's revenue. Here, we observed the largest and earliest declines, with procedures down 75% to 85% from early February to mid-March. This 6- to 8-week period represented the peak of deferrals. And since then, procedures in China have steadily increased, exiting the last week of the first quarter at about 40% down. So we saw some positive trend in China in the later part of the quarter. In April, China continued to improve and its averaging procedures being down about 25% with steady weekly improvement. While China experienced some deep declines, Japan, our largest market in Asia Pacific, did not see a material impact from COVID-19 in the first quarter. However, there has been a modest decline in procedures since the country announced the state of emergency last month. In April, procedures and revenue in Japan are down about 15% and have been stable at that level. We remain cautiously optimistic that deferrals will not approach the levels of China as the Japanese government has not announced nor have we observed or seen a widespread deferral of surgery in the 4 or so weeks since the state of emergency was put in place. Across all of Asia Pacific, in April, the deferral of procedures led to revenue being down about 25% versus the prior year. Moving to EMEA. The region decreased 11.7% in the quarter. Across EMEA, we saw some variability in the onset and timing of COVID-19, with 2 profiles emerging. One, countries impacted more severely, which represents more than half of the region, including countries like Italy, Spain, France, the U.K. and others, where we saw a significant reduction in procedures starting in mid-March and exiting the final weeks of the quarter down about 80% versus the prior year. Two, countries with a more moderate impact. This represents the remaining portion of the region and includes countries like Germany, Austria, Switzerland, among others. There, we saw reductions of about 60% in the final weeks of Q1. The level of impact in these markets continued into April, with both groups observing further declines. Overall, in April, we saw EMEA procedures or revenue down about 75% versus the prior year. While we've seen some recent encouraging policy actions in many parts of EMEA, it's still too early to tell what level of impact this will have on revenue uptake in these markets. Lastly, the Americas decreased 7.7%. Here, the COVID-19 impact ramped up materially in mid-March with the U.S. shutdown and with federal and state government's guidance to defer elective procedures. The final 2 weeks of the first quarter, the region saw procedures or revenue declined about 70% versus the prior year. Within the U.S., states were broadly impacted at about the same level. Through the month of April, we continue to see a decline in procedures with deferral rates of about 75% to 85% and revenue being down about 80% versus the prior year. Most recently, many states are taking policy steps to reopen elective procedures with the vast majority expected to do so by mid-May. It's too early to determine the ramp of procedures in those states, but this is an encouraging sign. So let's turn to our businesses for Q1. Our global knee business declined 8.3%. Prior to the impact of COVID-19, we saw strong performance in the category driven by improved operational execution and the continued positive launch of Persona Revision. ROSA contributed to the sales early in the first quarter, with COVID-19 negatively impacted overall capital sales. Our hips business declined 9.7% in the first quarter. Underlying performance in hips prior to COVID-19 was solid due largely to continued launch traction for Avenir Complete. Sports, extremity and trauma sales declined 5.8% in Q1. The first quarter decline was not as pronounced as in knee and hip, primarily due to the trauma/fissure, which is less selective by nature. However, we did experience a softer trauma market due to a generally mild winter and lower activity as a result of the global quarantine. Looking beyond Q1 for revenue. As you know, we withdrew our 2020 full year guidance on April 6. Impact of COVID-19 continues to be fluid, and there are multiple market dynamics and variables that we're unable to quantify at this time. Given the current environment, we will not be providing updated financial 2020 guidance. But we do want to share information and insights into our business that might provide shaping of our revenue expectations for the remainder of the year. We expect to see a sequential deepening of procedural deferral rates in the second quarter relative to the first quarter. As I mentioned earlier, we observed a consolidated revenue decline of about 70% in April when compared to the prior year. And to recap, in April, by region, we saw declines of about 25% for Asia Pacific, about 75% for EMEA and about 80% for the Americas. Within April, we observed fluctuations by market throughout the month, with many remaining stable and some slightly improving their revenue ramp. As a result, we project May to be similar or slightly better than April, with an improving trend in June as countries and states reopen and begin to ramp up elective procedures. We currently anticipate that the sequential improvement will continue into Q3 and then again into Q4 as procedures return. But the raising level of improvement remains fluid. Also, we do not assume a significant recurrence related to COVID-19 later this year. While we are encouraged by the recent leading indicators, our revenue trend could vary materially from the profile I just provided. Turning to our P&L and liquidity. We're taking a disciplined and proactive approach to mitigate the earnings impact of the pandemic and to enhance our liquidity profile. However, COVID-19 will continue to put pressure on our earnings and free cash flow profile through the year, driving significant deleveraging versus our prior expectations. In terms of our first quarter results, we reported GAAP diluted loss per share for the quarter of $2.46 compared to diluted earnings per share of $1.20 in the prior year period. Adjusted diluted earnings per share were $1.70 compared to $1.87 in the prior year. In addition to the operational drivers that I'll speak to as part of our adjusted results, GAAP earnings per share in the first quarter were negative and lower than the prior year due primarily to goodwill impairment charges related to operating segment changes and to lower future cash flows due to the pandemic. In addition, GAAP results were impacted due to higher litigation expenses and restructuring charges related to the restructuring program we announced earlier this year. For additional commentary on GAAP results, please refer to our first quarter 10-Q to be filed later today. Turning to our adjusted results for the quarter. Earnings per share were lower than the prior year driven by decreased revenue. Adjusted gross margin was 72.7% or 60 basis points higher than the prior year. While gross margin was higher in the first quarter, as previously guided, we expect pressure on overall gross margins in 2020. Gross margins were not significantly impacted in the first quarter by COVID-19 as the most pronounced impact was not felt until late in the quarter. However, COVID-19 will put additional pressure on gross margins for the remainder of the year due to less favorable mix and lower fixed cost absorption as a result of decreased revenue. Adjusted operating expenses were $831 million or a decline of 7.6% versus the prior year. Key drivers of the lower spending were reduced variable selling expenses related to lower revenues, the early impact of our restructuring program announced earlier this year and additional cost reductions as a proactive measure to deal with the pandemic. We were able to flex quickly on COVID-19-related cost reductions in the first quarter by leveraging the restructuring program already in place. Incremental cost reductions we took in March to deal with the pandemic will have an even larger impact into Q2. Overall, adjusted operating margin for the quarter was 26.1%, 50 basis points lower than the prior year, again, driven by lower revenues. Moving beyond operating margin. Interest expense of $51 million was down versus the prior year due to debt paydown through 2019. And our adjusted tax rate was 15.7% in the quarter, lower than expected due to the impact of certain favorable discrete items that we do not expect to repeat through the rest of the year. Moving to cash and liquidity. Given the unprecedented challenges facing us, we have taken a number of steps to enhance our liquidity profile, including securing an additional credit facility backstop, amending covenants for greater operating flexibility and moderating cash expenditures in the near term. We ended the first quarter with cash and marketable securities of about $2.4 billion, and we generated approximately $325 million of free cash flow in the quarter. Our ending cash position was higher than normal due to the execution of a $1.5 billion of new senior notes in early March. Those funds were used to term out a $1.5 billion senior note maturity early in the second quarter. To neutralize for this timing difference, underlying ending cash and marketable securities was about $900 million at the end of the first quarter. In April, we secured an additional $1 billion credit facility that will be in place through this calendar year, and we have our existing $1.5 billion credit facility that was in place prior to COVID-19. Combining cash and our available credit facilities, we have over $3 billion of immediate liquidity available to us in the near term. The credit facilities will have a gross leverage covenant of 5.75x through 2020 instead of the 4.5x covenant in place prior to COVID-19. Also, both facilities remain untapped. For more details about the new credit facility and the amendment through the existing credit facility, please refer to our Form 8-K filed on April 29. The steps we have taken should position us well to deal with the near-term challenges and set us up for strength through the recovery. Related to liquidity, our capital allocation priorities remain consistent with what we outlined earlier this year. But in the near term, we will focus our energy on navigating the challenges of the pandemic while strategically prepared to meet demand as end markets recover. In terms of our P&L for the remainder of 2020, we do want to provide some broad insights to help you think about the rest of the year. Moving forward, the majority of our remaining cost base is fixed in the near term. And as a result of deeper revenue erosion, we expect margins will be significantly impacted in the next few quarters, down from Q1 and negative in the second quarter. If the revenue trajectory improves in Q3 and Q4 as we project, we anticipate that margins and earnings will also improve. But earnings improvement may lag revenue improvement as we plan to increase our investments to prepare for market recovery. Free cash flow should have a similar profile to earnings. We do want to remind you that the situation remains fluid, and these comments represent our best estimates at this time. To summarize, our underlying financial fundamentals remain strong, and we have taken prudent steps to enhance our financial flexibility and liquidity profile. I'm proud of how the ZB team has responded to the crisis. We believe we're well positioned to address this challenge, lead in the recovery phase and accelerate our growth profile over the long term. With that, I'll turn the call back over to Bryan.
Bryan Hanson:
Thanks, Suky. And in closing, it's clear that the impact of COVID-19 is real and obviously material for ZB. But we do think it's also clear that ZB is positioned to address the challenge. And again, if I can leave you with those same 5 things, I just want to make sure that we get these points across as I think you've been able to hear. We absolutely feel confident in our ability to keep our team members safe, and that will remain our 1 priority as an organization. We have a very high level of confidence in our liquidity and financial flexibility to manage through this challenge. We have confidence in the recovery. It's just a question of the timing of that recovery, but a high level of confidence in the patient funnel being there. And we will continue to invest in key R&D and commercial projects. The fifth piece is that we truly do believe that given some of the changes we've put into place as an organization over the past 2 years, we will come through COVID-19 stronger than when we entered it. What we know is we have the absolute right team at ZB, and I want to thank each and every one of them for the amazing job they're doing right now. But we are highly confident that we're positioned to deliver value to our customers, our patients and importantly, to our shareholders. And with that, I'm going to turn the call back over to Keri to move into the Q&A portion of the call.
Keri Mattox:
Thanks, Bryan. [Operator Instructions]. With that, operator, may we have the first question, please?
Operator:
[Operator Instructions]. We'll take our first question from Chris Pasquale with Guggenheim.
Christopher Pasquale:
Bryan, I want to start off with -- obviously, not a surprise that the business was weak given everything that happened late in the quarter, but it does look like you lost a little bit of ground in hips and knees this quarter, which really reverses a recent trend of narrowing that gap versus peers. Can you talk a little bit about how you thought the quarter turned out from a competitive standpoint?
Bryan Hanson:
Yes. Yes, Chris. I'll tell you, it's -- I don't know that I would agree with the statement, to be honest. I think that you've got such a confusing quarter given day rate differences, given mix of business in certain parts of the world that may or may not have been hit as hard as other parts of the world from the COVID-19 issue. I think it's really challenging to look at this quarter in particular, truthfully any quarter, but this quarter in particular, and try to draw too much conclusion about either share gain, share loss, that type of thing. What I would say, though, is that we were feeling actually very good about our performance in both hips and knees before COVID-19, again, pretty much in every region. I was actually looking forward to this earnings call before COVID-19 because I was pretty confident. Based on the trend that we were seeing, everyone was going to be very happy with the performance that we had. So it's very difficult for me to know exactly what's going on with my competitors. But I would say is almost across the board, I'd say the performance is a little better than I expected. And pretty much everybody in their earnings call did reference the fact that they were feeling confident about their business. Now again, it's 1 quarter, but that would indicate that everybody felt that the momentum in Q1 was good. That ultimately bodes well for all of us. So I'd like to see us do well, and I'd like to see our competitors do well. That's actually a good thing, all those rise in those situations. So again, very difficult to be able to draw parallel to what our numbers look like versus somebody else for all the reasons that I mentioned. But the general momentum and the feedback and the messaging that I'm hearing bodes well for the market at least pre COVID-19.
Christopher Pasquale:
That's helpful. And then could you just give us a little bit more color on when you think recon volumes return to year-over-year growth? And should people be thinking about pre COVID expectations is still being a reasonable proxy for where recovery ends up? Or are you baking in some lingering impact from the economic fallout or from your patients perhaps not wanting to engage with the health care system?
Bryan Hanson:
Absolutely, Chris. It's tough because, as I said in my prepared remarks, I have a high level of confidence, not just me, by the way. This isn't my assumption. This is us talking to literally thousands of surgeons around the world on a weekly basis to find out how they're feeling about it as well. And there's clearly a lot of confidence around the large majority of patients coming back. Again, there's a lot of question marks on when it's going to happen. As I referenced before, there's a lot more complexity to this particular situation just given the volume of patients that are being deferred. As I mentioned, OR capacity will absolutely be something that we're going to have to consider, particularly in certain parts of the world. This access to PPE and test kits will be a factor. There's no question. And really just when the patient's going to be ready to come back in. So to be able to put a specific time frame in place is challenging. So what I would tell you is that my confidence is how they're going to come back. And we'll not only get to pre COVID revenue numbers, I believe we'll surpass that. We'll see a positive tailwind come when these patients come back in the funnel, and we'll see extraordinary growth at some point. I just can't give you the specific time. Generally speaking, as we think about it, as we provided in the script, we would say April is the most difficult, for sure, month that we're going to see. And we're going to see sequential improvement from there until we get back to normal. And then at some point, I would expect, again, extraordinary revenue numbers coming in as that patient funnel comes back into the mix.
Operator:
Our next question comes from Kyle Rose with Canaccord.
Kyle Rose:
Great. I just wanted to see if we could get some thoughts on the potential to move cases to the ASC in an effort to increase capacity over the near term from a recovery standpoint. I guess -- and then what types of cases you see moving there? And then when you're talking to your physicians, when they're thinking about putting or where it's appropriate, when they're thinking about scheduling cases again, what types of cases are being scheduled? Or are there any different dynamics that you're seeing that things being prioritized, complex versus relatively simple procedures? And just the overall timing of that return to volume specifically into Q2.
Bryan Hanson:
Yes. I think it's -- again, it's very difficult to say because there's so many moving pieces and parts, but just logical extension argument would suggest that patients may feel, may feel, I want to make sure that I say that, may feel more comfortable coming into an ASC setting versus an acute setting like a hospital. And again, we won't know that for a fact until we actually see the patients come back and get a true assessment of how much of those patients are coming back to the ASC versus the hospital. But one could assume that there would be some desire to not go into an acute facility and feel more comfortable in an ASC setting. And again, we'll know that when it happens. What I would tell you is that pretty much across the board, our procedures -- most of the procedures can be done in ASC setting, where our big volume comes in. And what we're seeing out of the gate, to be honest, is a higher volume of recovery in Revision cases versus your standard knee cases or hip cases. So clearly, those patients that have a desire to get in given kind of "a more acute issue" seem to be coming in first. But again, it's very difficult to say. It's pretty fluid, as I've suggested, but I would expect, generally speaking, that momentum towards ASC to continue. We don't see whether it accelerates or not. And I would expect those patients that are more acute and have a higher level of desire to get back in to come into the funnel first.
Operator:
The next question comes from Kaila Krum with SunTrust.
Kaila Krum:
Can you just speak to any updates on the strategy with your large joint robotic system? You mentioned that you're still investing there, but I'm just curious how or if your commercial approach may have changed for 2020, just given the current backdrop.
Bryan Hanson:
Yes. What I would tell you is, first of all, thanks for the question. We're -- we remain very excited about ROSA and just overall robotics and the desire to bring robotics into orthopedics. And there's nothing that we've seen in the short term that at all, in any way, shape or form, changes that viewpoint. We truly do believe robotics is going to be the future of orthopedics. What I would tell you is just honestly, as Suky mentioned, it had a very little impact for us anyway in Q1. And that's not surprising. It's not even concerning. The fact is most of the sales of a robotics program or capital program in general comes towards the end of the quarter. And I think as everybody knows, a lot of our robotics sales have been in the U.S. And so when the U.S. got hit so hard in the back half of the quarter, it's not surprising that a lot of those opportunities that we had got deferred. The good news is that we're not seeing cancellation of any of the deals that we had in place. We're seeing deferment of those, and we're continuing to see very strong demand for robotics overall. Still seeing people trying to get queued up for training, which is a very good leading indicator of where robotics is going to go. And so we feel good about it. We will absolutely flex with our customers. If customers are in challenging situations, remember, we have different ways, as we've said from the very beginning, of placing robotic systems. The real goal for us is to get them placed. And we'll work with our customers if they need flexibility in the way they acquire those systems and place those systems to make sure that we're flexing for their needs. The fact is we've got to remember that the major benefits associated with ROSA or robotics placement isn't necessarily the capital sale upfront. It's nice to have, no question about it, but it's really more around the annuity. And also, quite frankly, when you do place these systems with the right type of contracting strategy, you also see kind of a by-product effect of better pricing stability because you typically get longer-term contracts in place. But if I just look at the annuity revenue associated with it, you get disposable revenue that is an uptick to the share of wallet you get in every procedure that is dedicated and needed for a ROSA procedure. You get the pull-through of competitive volume just kind of naturally occurs when you get a ROSA system in place, and you also get the service agreement. So for us, this idea of flexing to help our customers in a time of need is real. We will need to do that, but the strategy holds. We've got to make sure that we're getting ROSA placements in, getting more robotics out, so it can help the patients with better accuracy and, ultimately, certainly helps the overall market growth as well.
Operator:
Our next question comes from Joanne Wuensch with Citibank.
Joanne Wuensch:
Could you please spend a minute on what it takes to roll out mymobility, and how you plan on -- or how you expect on seeing this in action as we get back to sort of a new normal? And I'm going to sneak a second question in, which is, when you think about that new normal, when do you think procedures will be back to sort of a stable or relatively normal run rate? This year or next year? Or if you get more granular than that, that would be great.
Bryan Hanson:
Yes. I don't have -- I'll just hit the second question first. I don't have specifics on the normal time line as we referenced. I would say it's more likely next year, though, if I was just going to give you a very broad view of when I think it's going to come. It could be earlier than that, but it's very difficult to say. There's just a lot of moving pieces and parts right now. When I talk about mymobility, I think there's -- in any crisis situation, there's this opportunity to move away from crisis management to crisis optimization. mymobility is a platform that we've had out for a while that has a good traction. But I can tell you the interest in an application like mymobility that allows for virtual interaction with the patient has gone up fivefold since this whole thing has started, with the social distancing requirements. And people really have a significant interest to get it out. That was the reason why we came out with the LE, how do we do this in a way that allows for absolute rapid deployment while still giving most of the characteristics of mymobility to the patient and to the surgeons so they can enjoy it while they're in this unnatural kind of COVID environment. So the positive news is demand for this type of technology has gone up dramatically. And our team is pivoting very quickly to make sure that we have the right launch of mymobility to be able to take advantage of that and to make sure that we're deploying it in those accounts that are interested as quickly as possible. So again, I'd rather not have the situation happening right now. But the fact is it is opening up people's eyes to this type of technology, and that benefits us because we already had it.
Operator:
We'll take our next question from Amit Hazan with Goldman Sachs.
Amit Hazan:
I want to come back to China. They're obviously a couple of months ahead of us in this whole thing, and they've got a patient backlog there too, of course, but utilization seems to kind of still be stuck around down 25% through April. And I'm wondering if you can help us, if this is explained better in your view through the lens of hospital capacity issues or through the patient demand side factors like psychology, and if that at all helps to color what we should expect in the rest of the world.
Bryan Hanson:
Yes. I'll take a shot at this just maybe topically. And then, Suky, if you have anything to add, feel free to do that, obviously. What I would tell you is that Suky was referencing what we have seen so far through April in China. And I would say, I'm actually very pleased with the recovery. I would be happy to see every other market that's being impacted by COVID-19 respond in the same way, with the same level of exuberance in the recovery. If we look past April, just to give some more specifics, and I think it's warranted here just because it is our longest-standing proxy of what could happen. And I'm not saying this will happen. But the fact is we're already suggesting that as we get into June, China could be at 100% of what they were doing prior to COVID-19. And then post that, there's folks there on the ground that would expect us to be above 100%. So again, we start to see some of that extraordinary growth come from patients coming back in the funnel. I have not heard from the China team a lot of concern around the specific concern of a patient coming back into the funnel. Whether that applies to other markets or not, who knows, but I'm not hearing that as a specific issue at least so far in the China market. So again, I don't want to read too much into what we're seeing in China because there's a lot of differences that are occurring out the marketplaces. But I'm pretty pleased actually with the recovery that we're seeing in China and the timing of it. I don't know, Suky, if you had anything additional to add?
Suketu Upadhyay:
I think that's a good summary, Bryan. Only color I'd add on top of that in the midst of those numbers, at the deepest part, China was doing about 25% of their normal run rate. Within 2 months, they're up to 75% in April. So we're seeing a pretty steep V there. And again, as Bryan added, we expect that trend to continue over the near term. It's too early to tell if that same shape and pace of recovery will extend into other markets, but we're encouraged by what we saw in China.
Operator:
Our next question comes from Larry Biegelsen with Wells Fargo.
Lawrence Biegelsen:
Bryan, one on pricing. One of your competitors called out the potential for increased pricing pressure given the situation that hospitals are in. Can you comment on that? What is your expectation going forward?
Bryan Hanson:
Yes. What I'd say, Larry, is that I don't -- to my view anyway, I don't see any real difference in pricing pressure. I mean, the fact is we've had austerity measures in the past. We have constant bombardment on pricing pressure every day of our lives, and I could certainly see where people might be looking for more. But the fact is there are competitive forces in place that would -- the pricing doesn't go down unless somebody gets the pricing. And I truly do believe in this situation. You're going to find that pricing will continue to be similar to what we've seen in the past. It's still not an attractive pricing environment. 2% to 3% is what we've always said. But I'd be surprised in the short term if we see anything deviate dramatically from that. As a matter of fact, as I said before, what we're really focused on right now is leveraging broader contracting, either in concert with ROSA placements or robotic placements or just cross-business contracting using multiple categories, with the idea that we would be able to help our customers in the time of need, have longer-term contracts. And as a result of that longer-term contract, actually have more pricing stability. That will be our focus. I don't want to predict better pricing, but I also don't want to predict worse pricing in the short term here.
Operator:
Our next question comes from Bob Hopkins with Bank of America.
Robert Hopkins:
Bryan, talking to the whole team, thanks for the details on April, very helpful. Would love to just get your thoughts on 2 things as it relates to expenses. Could you just clarify what percentage of your costs you consider to be fixed? And then as we look forward, maybe hypothetically into next year, if revenues get back to something that approaches 2019 levels, would margins also get back to 2019 levels? Or is there a reason why the recovery in margins may take longer than a recovery in revenues?
Bryan Hanson:
Suky, why don't you go ahead and tackle that? And then I've got some color commentary afterwards. I'll provide it.
Suketu Upadhyay:
Yes. So as we said in our earlier remarks, or I said in my earlier remarks, Bob, first of all, thanks for the question. We said more than half of our cost base is fixed in the short term. That breaks out a little bit differently across cost of goods and within OpEx. And cost of goods, it's probably much less than half is fixed. And then as you get into OpEx, I'd say a little bit more than half is fixed. And then the weighted average then takes the overall cost structure as more than half being fixed. So that's how we think about our overall cost base. We did implement a number of cost-preservation activities in Q1 that will extend into Q2 to help with overall liquidity and earnings. And again, you'll get a full quarter of those into the second quarter. So we do expect that to be a bigger impact. Having said that, if we do see a solid ramp here in May and into June, we may elect to start to invest even sooner than Q3 against the business to ensure that we're ready from a supply standpoint, from a channel standpoint, from a commercial standpoint to meet the end market recovery. Relative to margins, we do think it could be slightly delayed versus revenue uptake, primarily because of some of those spending reductions we're taking that we're deferring. We may catch up on in the rest of the year. And then in addition, within cost of goods, some of the fixed overheads ultimately that might fall out as unfavorable variances because of lower revenues could get deferred and be recognized over time in the future. So those are 2 factors that could lead to margins ultimately lagging slightly behind the revenue uptake as we go forward. It's too early to tell as to when margins could get back to 2019 levels. But as we said, Q2 is probably the low watermark, and then we would expect margins to improve as revenue improves.
Bryan Hanson:
Just one additional comment on that. I think Suky's right on the money. But also it's very clear, when revenue comes back, that obviously has a direct and almost immediate impact to margins in a positive way. As we have some deferred expenses, hit that, it could delay it a little bit. But the fact is nothing is better than increased revenue growth to enhance margins. And remember, as I mentioned in the prepared remarks, and I believe Suky did as well, we do have our restructuring program in place live and well. And the whole intent behind that restructuring program is to be able to continue to invest for growth, but do so while expanding margins. And we're pretty explicit the last time that we had talked about our goals associated with those margins. And the hope is this gets behind us, and we get right back on track with what we had predicted the last time.
Operator:
Our next question comes from David Lewis with Morgan Stanley.
David Lewis:
Bryan, just maybe some one broad comment, one related question. The -- this dynamic of the economy, this kind of consensus view that orthopedics is sort of more economically sensitive relative to other elective procedures across broader medical devices. I wouldn't hear a lot of talk about economy on this call. So do you accept that view that recon is sort of more economically sensitive? And sort of related to that -- but I think about your unique businesses, dental, recon and trauma, they're all very different. How do you see the recovery across those 3 different businesses?
Bryan Hanson:
Yes. I think I'll hit the second one first. I think, trauma, obviously, will be the one to rebound more quickly. It's been down, obviously, and what you know is people just aren't out. And as a result of not being on, not being active, trauma business just gets hurt. But the fact is, as people start to get to street again and start to move again, we would clearly expect trauma to be the thing that recovers the fastest. Recon would be next for us. And even the acuity level of those recon patients would kind of dictate who comes first into the funnel. And then dental would clearly be the cleanup in the way that I would look at it, be the last to recover for obvious reasons associated with the dental marketplace. When I think about the impact that economic downturn has on ortho, I think, in the past, we've seen that it can have an impact. What we're doing when we're modeling this out, David, when you just think about the number of moving pieces and parts, we're assuming that the natural business, the natural growth of the business remains pretty consistent, that you're going to see the typical patient flow that would have been coming in over the rest of this year, over next year when things recover. And then you're going to see that incremental patient flow come because of those deferred patients. So if anything for me, when I think about 2021 and potentially even beyond, I think we could have an opportunity as a market, which would be a false positive, but I think we could have a situation where you're seeing extraordinary growth during that time rather than depressed growth because of any kind of economic recovery issue. But that's just, again, just my view, based on data points that we're getting from folks that are out there in the world and what they're seeing and then also our own teams. I would just tell you too, right now, we have an unprecedented amount of outreach to our customers. This is not just us sitting in a room, thinking about what's going on. We literally have thousands of touch points every week to surgeons and customers around the world to get insights. We're loading that through our sales force program, and we're able to use those insights to be able to give us a view of what we should expect. But that's just my personal overview based on those insights that I have right now.
Operator:
And that concludes today's question-and-answer session. At this time, I will turn the conference back to Keri Mattox for additional or closing remarks.
Keri Mattox:
Thanks, Lauren, and thanks, everybody. I know there were some other questions in the queue. Unfortunately, it is right up at 9:30, so we are going to wrap here. Of course, the IR team is available all day today, and we'll be speaking to many of you. If you have additional questions, please don't hesitate to reach out. And thanks so much for joining us today. Stay safe, and be well.
Bryan Hanson:
Thanks, everyone.
Operator:
That does conclude today's conference. Thank you for your participation. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet Fourth Quarter 2019 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today, February 4, 2020. Following today’s presentation, there will be a question-and-answer session. At this time, all participants are in a listen-only mode. [Operator Instructions] I would now like to turn the conference over to Cole Lannum, Senior Vice President, Investor Relations and IRO. Please go ahead, sir.
Coleman Lannum:
Thank you, operator, and good morning, everyone. Welcome to Zimmer Biomet's fourth quarter 2019 earnings conference call. In the room with me today, we have Bryan Hanson, our President and CEO; our CFO, Suky Upadhyay; and our new Senior Vice President of Investor Relations and Chief Communications Officer, Keri Mattox. Now before we get started, there are a few things I want to go over with you. I'd like to remind you first that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by the forward-looking statements due to a variety of risks and uncertainties. Please note we assume no obligation to update these forward-looking statements even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties in addition to the inherent limitations of such forward-looking statements. In addition, the discussion on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within the earnings release found on our website at zimmerbiomet.com. With that, I will now turn over the call to Bryan. Bryan?
Bryan Hanson:
Thanks, Cole. I appreciate it. And before I jump into it, I just wanted to say the congratulations, first of all, to Keri. Obviously, Keri Mattox, it's her first call with us at Zimmer Biomet in her new role. I'd say it's early on, but we're pretty excited about what we think she is going to bring to the table. So I'm looking forward to that. I also want to make sure that I take just a minute here and say, thanks Cole. It's been harder to leave, but already two years that we've been working together in this capacity. And I would say that we've come a long way and a lot of that has to do with your guidance along the way. So, I certainly appreciate it. I know you're not going anywhere, we're going to have access to you, but this will be the last time you’re on one of these calls, so I wanted to make sure that I call you out for what you've been able to do for us over the last two years and look forward to the next year together. All right, so getting into the quarter. We are encouraged by our performance in the fourth quarter. We posted solid revenue growth slightly above our weighted average market growth rate expectations and grew earnings per share faster than revenue. This was driven by improved performance versus prior year across all geographic regions as well as most of our businesses. We also made further progress in executing on our short-term priorities; supply, quality remediation, new product introductions, and ZB’s mission and culture. We also continue to invest for growth. This progress has laid the foundation for further innovation and commercial execution that will drive our accelerated growth over the long term. These are all important steps forward; and while we’re happy with our progress, we're certainly not satisfied. Rest assured that we're still striving to continuously improve our business, our performance, and the value we deliver to patients as well as customers and investors. Along those lines, let me talk about the team's momentum around the key short-term priorities. Regarding supply, we have consistently met customer demand and improved service levels further enhancing the confidence of our global sales teams and putting them back on offense. With this supply stabilization, we are focusing more on opportunities to decrease the complexity and increase the efficiency of our supply chain. I'm happy with our progress thus far. On quality, I can confirm that the FDA recently concluded re-inspection of our Warsaw North facility. This inspection was anticipated based on the progress reports we've been providing the FDA on site readiness. We want to thank the agency for a productive and collaborative visit. By way of background, the FDA last inspected this facility in April 2018, and we've been executing a comprehensive remediation plan over the past couple of years. We believe the latest FDA inspection validates the significant improvement and progress that has been made at the Warsaw North facility. Not surprisingly, the FDA issued observations at the conclusion of the inspection, and we are confident in our ability to address them to FDA satisfaction. Our anticipated path forward with the FDA is fully contemplated in the 2020 guidance that we provided earlier this morning. We look forward to continuing to partner with the FDA as we strive to make Warsaw North a best-in-class medical device manufacturing facility. Let me take a moment to thank our quality and operations teams for their tireless work and dedication to patient safety. What they have accomplished over the past two years and what I know they will deliver for ZB moving forward is impressive. With improvements made in supply and quality, we also continue to sharpen our focus on innovation. Our enhanced R&D efforts drove significant new innovation in 2019 and give us increased confidence in our new technology pipeline as we move into 2020 and beyond. And these programs increasingly include enabling technology and solutions around our implants such as robotics, mini robotics, informatics, and operating room efficiency. While the implant is core to what we do, our goal is to provide a complete ecosystem that is both patient and customer centric. At the upcoming AAOS meeting in March, we'll showcase additional innovations inside this ecosystem that connect our implants, data, and robotics, all designed to optimize decision making and improve patient outcomes. Moving to mission and culture. We continue to communicate and drive the mission of the ZB organization. I can say today with confidence that everyone in the organization considers themselves part of one team. Our strategy is very clear and cascades down to all team members in the organization. It's important that everyone knows where we're going and how we're going to get there. Now turning to our fourth quarter results, all three of our regions performed well versus prior year with strong performance from Asia Pacific and improving performance in the Americas. Relative to our businesses, we're pleased with the performance of the knee franchise with solid results across all three regions. Our core knee business accelerated, driven by Persona, including the recently launched Revision system. ROSA Knee also accelerated and drove a little more than 50% of the overall global Knee growth. ROSA placements were strong, accelerating from Q3 and our customer pipeline continued to grow supported by a very positive feedback so far. We project continued growth with ROSA in 2020 as we increase our commercial efforts, including salesforce expansion and enhanced surgeon training support. In summary, we are very pleased with the ROSA Knee launch and the overall robotics uptake. While S.E.T continues to be an important focus area for us, it is not yet delivering at our goal of durable mid-single-digit growth. We will continue to prioritize innovation and accelerate the expansion and investment in our specialized sales channel in order to drive scale in the high growth S.E.T markets. Our dental team delivered its third consecutive positive growth quarter. The team’s focus on strategic priorities, execution and culture, along with the targeted investments in key areas continues to drive the business forward. We still have much to prove in this business, but I'm happy with the current momentum and the performance of the dental team. Relative to our Spine & CMF business, although we did see improvement from Q3, we continued to perform below market in the quarter. The primary focus areas for this business will be working through the final steps of our channel consolidation and leveraging our new product pipeline, including recent and upcoming product launches. We are making steady progress driving innovation and shaping the future of this organization. We’ve built a strong foundation and are now better positioned to accelerate our innovation and execution strategy. I am encouraged as we reshape Zimmer Biomet for sustained success. With that, I'll turn the call over to Suky to get further into the financials.
Suketu Upadhyay:
Thank you, Bryan. We delivered solid financial performance in the fourth quarter with accelerated revenue growth and leverage earnings, while increasing investments for long-term growth. Also through robust cash generation, we continue to make progress in delevering the balance sheet for strategic flexibility. I'll provide some highlights on our fourth quarter financial results and unless otherwise noted, the numbers I will be discussing on a constant currency basis. Net sales totaled $2.1 billion, a reported increase of 2.6% over the prior year with an increase of 3.2%, excluding the impact of foreign currency changes. During the quarter, all three of our geographies performed well. Our Asia Pacific team delivered 8.6% sales growth driven by continued strength across both developed and emerging markets. The Americas increased 2.4%. The strength in knees and hips driven by new product introductions, supply stability and improved commercial execution. Our Europe, Middle East and Africa team delivered 1.4% revenue growth led by strength in developed markets. Turning to our businesses. In Q4, our global Knee business grew 4.9% with improved execution and new product launches. Our Hips business grew roughly in line with market growth at 3.2% and was aided by the recent launch of Avenir, where we are seeing good early market acceptance. S.E.T grew 3.1%, slightly below our expectations, but we remained focused on growing that business at mid-single digits over time. Dental posted another solid quarter at 5% growth, driven by increased commercial and channel investments throughout 2019. Spine & CMF posted 0.2% revenue growth. While the growth was positive and sequentially better, we still have more work to do to stabilize the business. Turning to the P&L. We reported GAAP diluted earnings per share for the quarter of $1.54. Adjusted diluted earnings per share were $2.30, 5.5% increase over the prior year. Better adjusted operating margins and lower interest expense drove this leveraged earnings profile. Adjusted gross margin was 73.1%, a sequential improvement, an increase over prior year due to higher volumes and favorable timing of costs within the quarter. Adjusted operating expenses increased sequentially due to sales commission and investments across commercial and R&D priorities in our Knee and S.E.T. businesses. Overall, adjusted operating margin was 29% in the quarter. Moving beyond operating margins, interest expense of $52 million was down both sequentially and versus prior year due to debt paid down. Lastly, we had solid free cash flow generation of $295 million in the quarter and paid down an additional $161 million of debt, further deleveraging the balance sheet. It was a solid quarter. Looking ahead, our growing confidence in the business is evident in the 2020 guidance that we provided in our press release. Starting with revenue. While quarterly results may fluctuate due to seasonality and timing, we expect our full-year cost and currency growth to be between 2.5% to 3.5%. The first quarter will benefit from about one additional billing day with no material impact expected in the remaining quarters. We expect our adjusted operating margin for the full-year to be between 27% and 28%. Our adjusted effective tax rate should be between 16% and 17%. And we expect adjusted diluted earnings per share to be between $8.15 and $8.45. Against the backdrop of these 2020 expectations, I'd like to spend a few minutes on incremental steps we're taking to enhance shareholder value and to move our financial profile closer to top quartile. We have begun to implement the comprehensive multi-year restructuring plan with the objective of reducing costs and driving a mix shift of investments to higher priority growth opportunities. We estimate that these activities will generate gross annual adjusted pretax operating expense savings of approximately $200 million to $300 million by the end of 2023. This program gives us additional confidence that we can invest for growth and accelerate adjusted operating margins. I know the next question will be what does accelerate margins mean? While we expect to deliver operating margins of at least 30% by the end of 2023. To support this restructuring, we estimate approximately $350 million to $400 million in one-time cost over the same period. Consistent with this, during the fourth quarter, we recorded a charge of $31 million. As part of these restructuring activities, we've also reorganized several businesses to drive enhance strategic alignment across our key growth areas. As a result of this reorganization, you can expect that we will modify elements of our external reporting in the first quarter of 2020 and we'll share that information with you before our next earnings call. With that, I'll turn the call over to Bryan.
Bryan Hanson:
Thanks, Suky. And in summary, we're proud of the progress that we are seeing in 2019 that we've clearly stabilized many parts of the business. We've made key investments in priority areas. We drove better topline growth and delivered solid sustainable financial performance. There is clearly more work to do. We entered 2020 with increased confidence in our business and remain optimistic about our future. Now I'll turn the call over to Cole and Keri to manage the Q&A portion of the call.
Coleman Lannum:
Thanks, Bryan. Before we start the Q&A session, I want to again remind you to please limit yourself to a single question with a brief follow-up if and only if needed. [Operator Instructions] With that, operator, may we please have the first question.
Operator:
Thank you, sir. Ladies and gentlemen, at this time, we will now begin the question-and-answer session. One moment please for the first question. We'll take our first question from Raj Denhoy with Jefferies.
Raj Denhoy:
Hi, good morning. I wonder maybe I could start with the knee growth in the quarter. It really stood out. So, Bryan maybe a couple of questions there. One, can you maybe offer whether you think you have stabilized that business on an underlying basis? You offered that half of the growth was from ROSA, but on an underlying basis, do you feel your share position is now secure? And then on ROSA, is there anything more you can offer in terms of where you're seeing placements, what the demand has been? Just really anything you can offer in terms of how that system is faring?
Bryan Hanson:
Yes, absolutely. I would tell you that we're pretty excited actually about the quarter. It’s unmistakable with that across the business, but particularly knees was strong for us. And what I like about it, in addition to us, we saw strength in other parts of the market. So I know it's just one quarter. We don't want to get too excited about that, but the fact that we were able to surge in the market as others did, I think that's a good sign. And yes, ROSA was clearly a big part of that contribution in knee growth. As we said, it's a little bit more than half of the overall growth. But even when you look at the base business, I would say that we're seeing that business move as one would expect. It's not where we need it to be. I need the overall market in knee, our business in the market in knee to be able to outperform the overall market. We're not there yet, but the fact is we're definitely seeing traction in base knee as well. It's actually one of our best growth quarters in base knee that we've seen since the merge. Well, what I would tell you is that ROSA demand is very strong. We have – probably what we do have the largest funnel right now for replacements than we've ever had. We've done over 2,000 procedures already. And again, we’re just a couple of quarters into this launch, so that would tell you that we're really seeing acceleration of focus in this area. I had an opportunity to be out in the field and see a few cases, one particularly on the West Coast where I had a surgeon continue to look across the operating room and say, “I couldn't do this before without ROSA,” who is making 0.5 millimeter adjustments in tissue balancing and getting real time feedback in the procedure, and he was practically giddy about the response he was getting from the robotic system. So again, I think people are seeing this. As a result of that, more people are desiring to get trained on the system, and we're going to continue to see that momentum go forward. It was great to see our competition have a really strong quarter as well. That tells you that the uptick in robotics is real and that benefits all of us. So again, I'm pretty happy with where we are right now with base business as well as momentum with ROSA. I still have a lot to do. I think it's going to take us some time to get above-market growth in knee. Remember, we have a very large base that's going to take time to influence it because it's a significant number. We still have some of that negative inertia associated with the competitors' placements of robotics. It's going to take a while for us to disrupt that inertia, but I think we will over time. And we still have the major products that are out there that are launching, they're doing well, but they're early. So again, I feel really bullish in the area, but it’s just going to take us some time to be able to get that business growing above market.
Raj Denhoy:
Great. Thank you.
Coleman Lannum:
Thanks for that. Thanks, Raj. Next question please.
Operator:
Our next question comes from Vijay Kumar with Evercore ISI.
Vijay Kumar:
Hey, guys. Thanks for taking my question. If I could, maybe a two-part question on – one, ROSA expectations for 2020. I know you said a sequential step up in placements for 2019. Is that still the margin assumption for 2020? And on the margin side, Suky, implicitly we're looking at 60 basis points, 70 basis points of annual margin expansion. When does that kick in, right? Is that kick starting in 2020 or is that more for 2021 nuance, and congrats and thanks guys.
Bryan Hanson:
Okay. Yes, I'll start off with the ROSA and cast our view certainly, obviously on the margin piece. Yes, as I said before, ROSA funnel is as strong as it's ever been. We're adding commercial infrastructure to be able to support that, and we're adding significant training capabilities so that we can get people trained with a safe and effective use of the product. So, I absolutely expect 2020 to be better than what we saw in 2019. It's kind of logical just given the fact that we'll have it for the full year. We did not have it for the full year in 2019, but that momentum is real. I would expect it to continue and certainly be a driver for us in 2020.
Suketu Upadhyay:
Yes. Thanks, Bryan, and thanks Vijay for the question. Regarding margins and the overall restructuring program that we announced just a few minutes ago, you're right, we talked about 30% operating margins by 2023, at least 30% operating margin. So your math is right. If you sort of took a linear glide path, that's about 60 basis points, 70 basis points per year. However, I would say that, it may not be linear, right. Depending on the overall revenue profile, our investment profile over that three to four-year horizon, that margin expansion could be a bit lumpy and it could fluctuate. So, I wouldn't look at it as sort of in a linear fashion. Regarding 2020, operating margins completely consistent with how we've characterized this all the way through 2019 including our third quarter call, where we said we see the opportunity for modest operating margin expansion in 2020, and if you look at our guidance that's represented in the top half of that guidance. But we also said, given the number of attractive opportunities we have across the business, that we may use some of that margin upside to instead invest against the business for topline growth, because we do see topline growth as the best, most durable pathway to long-term, margin expansion, earnings growth, and shareholder value. And so, that's reflected more in the bottom half of that overall margin profile guidance. I would say we're in early days as part of that restructuring program. However, we do expect to see some benefit into 2020 and that's been fully incorporated into the margin guidance that we've provided today.
Vijay Kumar:
Thanks guys.
Coleman Lannum:
Thanks, Vijay. Next question please.
Operator:
Our next question comes from Matt Miksic with Credit Suisse.
Matthew Miksic:
Hi. Thanks so much for taking the question. Just one on, follow-up on Raj's question on knees, and then I have one follow-up as well, if that's okay. On the knee growth, Bryan, you mentioned, it's going to take a while to get above market growth in knees. If you could talk maybe a little bit about where you are in the U.S. in terms of holding share? And what the timing looks like in the U.S., given the trajectory robot sales and some of the other projects? You mentioned timing to get back to or get above market growth?
Bryan Hanson:
Yes. So I won't give specific timing on that. But just know, we have our sights on getting above market growth and we also believe that we have the fuel to do it. And I'll just go through a couple of those things that I think will give us that confidence. But when I think about the U.S., we're still below market. We're still seeding share, but the rate that we're losing market share is much slower. So we're clearly closing that gap. And our confidence level is high. I mean the U.S. momentum is real. I was just at the kickoff meeting for the Americas. Obviously a big part of that is the U.S. commercial organization. And I can tell you in all my years of doing kickoff meetings around the world, I have never been to an event where the energy was as high as it was in that meeting. So people are ready to go. They're fired up and that momentum is real and that's meaningful. Beyond products and innovation, supply and everything else, the way people feel and their confidence, absolutely drive traction in the field. And I can say right now it’s there. So that's probably the first thing that we have a pathway to get above market. The real brass tacks is associated with products though. As I mentioned before, ROSA strength is real. I've also seen as I'm out in the world and I'm seeing ROSA placements. I'm seeing people that we didn't even expect, surgeons, that are competitive surgeons now getting trained rapidly to understand how to use our robotic system. And as a result of that over time, we're going to expect to see that pull through because they have to use our implants when they begin to use the ROSA system. That will take time because they have to first drop the implants that they're using, really get trained and understand how to use the robotic system that we have, and then we're going to get that uptick. But that will take time because we're early in the launch, but it will happen. When I look at cementless, we're still seeing traction in Persona, in Persona cementless. I'm not going to get into specifics here. But there's no question, this gives us an opportunity for mix. A little bit of conversion opportunity too particularly tied with robotics, but a big part of it is mixed benefit. And then Persona Revision, I got to tell you, there's a few different ways, we can drive revenue growth here. But the traction we're getting and the momentum that we're getting is bigger than we expected. As a matter of fact, we're actually building triple the amount of S.E.Ts. that we expected based on the demand that we're seeing. So there's no question in my mind, people love the Revision system and its being well accepted in the marketplace. Really three different ways that we can grow business inside of Revision. First one is, I've already got Persona users out there that are not using my Revision system because we're just launching it. There's no reason, if they like the Persona product that they wouldn't convert to the Persona Revision system. So that's the first order of business. Go to our current accounts, where they're using Persona and get to Revision business. The second one is, I've gotten an opportunity to get out and get those surgeons that wanted to move to Persona, but wouldn't go there until we got the Revision system. And the third one is just competitive conversions. We have a great Revision system. Revisions are always a little more challenging for surgeons. So when you can make Revision easier as a result of a system like Persona, there's an attraction to that system that opens the door to competitive conversions. So those are the pieces that I know we have in place to get us to at or above market growth. But the key thing is, it's going to take time. We're early on in the rollout of these things, but I can guarantee it's going to happen. It's just a question of when, and I just can't give a specific time right now.
Matthew Miksic:
I appreciate that color. And so maybe…
Coleman Lannum:
Matt, sorry. Matt, one question per person, sorry. Next question please.
Operator:
Our next question comes from David Lewis with Morgan Stanley.
David Lewis:
Okay. I'll keep it to one question there Cole. Bryan, let's now talk about the 2020 outlook. I think you’ve been adamant around the 2% to 3% growth. This is 50 bps better on the margin and the comps are going to be tougher in 2019. So you're clearly guiding to improve the momentum in the business at 2.5% to 3.5% for 2020. Can you sort of walk us through and where that confidence is coming from either by segment or sort of across the business broadly? I think that's the kind of the key focus here on the call. Thanks so much.
Bryan Hanson:
Yes. So David, it would've been funny if you were to come on and say get a three-part question, but you lost it. So I would say, yes, it's a number of things. First and foremost, it's just the momentum we're seeing. I mean if you look at the last couple of quarters, there's no question that there's a difference in the business right now that the momentum is real and we've proven that now for two quarters. And that's a big confidence booster for all of us. If you think about it, the performance is good, but there hasn't been that many quarters as a company that we've had that type of performance. So it have to in a row does give you some of that confidence. So certainly, that strength across all regions, that performance that we've had already and the future-looking impact of new products gives us the confidence to be able to take the revenue. I'm not going to follow-up guidance, but our view of what 2020 is going to look like. So that was really the major impact. I mean, I look at it and say, we're still not delivering what I expect us to deliver in S.E.T. But the investment is there. The new product innovation is there. So that's going to happen. I have confidence it’s going to happen. We're not where we want to be yet, which is given the amount of investment and focus in this area, I know its coming. I already talked about knee. Hip just continues to hang in there. The Avenir Complete is going well. We have a robotic application that will be coming soon. That maybe the catalyst for us to be able to boost the hip performance as well. We've been hanging in with markets, but I'd like to see that above market. And I believe that the robotic application would give us that momentum. So again, a lot of things moving in the right direction. I always want to balance that with some of the things that could be challenges for us. The fact is, we do have great momentum in our products. The demand is high, but they're early, so that momentum has got to continue. Suky just talked about a multi-year restructuring program, which is a must-have because it's going to allow us to invest for growth while also driving margin expansion. But there's always a risk of disruption when you put a program like that into place. So I'm trying to look at the ebbs and flows, the puts and takes for our business and give you guys what we really believe is going to happen in 2020. And there's enough momentum, there's enough positive to offset all those things that could be disruptive. And that's why we took the number up.
Coleman Lannum:
Thanks for that David, and thanks for complying with one question rule. Operator, next question please.
Operator:
We'll take our next question from Bob Hopkins with Bank of America.
Robert Hopkins:
Great. Thank you and good morning. So I guess my one question I'd love to Bryan, if you don't mind follow-up a little bit more on your comments on S.E.T. And just maybe a little more specifics on kind of what's coming and when we might see better growth? And obviously a lot of people are trying to wonder if some of the merger activity going on around you might lead to some opportunities, so maybe just a little more color on S.E.T.?
Bryan Hanson:
Yes. So when I just take a step back, when I think about this business over time, obviously we're not suggesting in 2020 being at the overall business ZB being at a mid-single-digit growth because that's where we need to go. When you think about our strategic pillar of being a top quartile top performer in total shareholder return, it requires us to increase our growth rate. We have to get to that mid-single-digit growth rate. And one of the major contributors to that is going to be a sustained kind of durable growth rate in that market growth range for S.E.T. As a matter of fact, really need to see it on the top end of that range, that mid-single-digit range, and we need to see the outperformance of needs. So those are the two major categories that we're going to be heavily focused on to ensure that we get ZB at mid-single-digit growth. Again, over time, but that's what's got to happen. When I think about us being able to do that, he was pretty clear to me, we have the formula in place. Number one, we've got to be able to increase the innovation pipeline and we've been doing that, not just the pipeline, but the cadence of those new products. Things like the Alliance, Glenoid that we're launching, that gives more personalized way to do a total shoulder is going to be exciting to surgeons. We're early on in this. No, but I can tell you right now. The response from surgeons is very strong. The signature one planner, we lagged in this area. When you look at pre-surgical planning, we no longer lag in this area and we have a lot more coming when it comes to informatics and our robotics in the space as well. So I feel confident that the innovation cycle is real, it's coming and it will have an impact. And the other one that we've been talking about for a long time now and we're really doubling down and is continued investment in a dedicated channel. This takes time, obviously, the hope would be that with some of the disruption out in the marketplace that facilitates quicker expansion of our sales organization and we're certainly going to try to make sure that we take advantage of that. But the fact is we've got to be able to get that channel in place. We're investing in it now. And then the operating mechanisms around that channel to make sure that we're driving accountability and focus brings all these things together. So I know the formulas there, the variables are all lined up. We just got to solve the equation and it's just a matter of time. So I have high level of confidence it's going to happen. It's just not happening yet and it's not happening durably yet.
Coleman Lannum:
Thanks for that Bob. Next question please.
Operator:
We'll take our next question from Richard Newitter with SVB Leerink.
Richard Newitter:
Thank you. Just to follow-up on the restructuring. Can you maybe just elaborate a bit on the types of projects or initiatives and the timing within that three year, but that three year trajectory, I guess really, if you could also parse it out between you things like sales incentives, structure changes or any kind of incentive structure changes throughout the organization? What's low hanging fruit versus kind of maybe the harder stuff to go after and when in the timeframe, so that's where your timeframe, you're going to go after each? Thank you.
Bryan Hanson:
Yes. Why don't I just kind of provide just a real general overview of what we were trying to accomplish in the restructuring and again early days. So it's we don't know that we've done these things yet, but we're just the intent of the restructuring and then seeking maybe getting some more detail of the underlying assumptions. First of all, the whole goal of this was to drive better alignment, better accountability and efficiency, right. So we really do believe the restructuring is a better way to manage the business with efficiency included. And if I just think about it, we've taken all businesses now, we have them under one leader and the whole intent behind that is to have faster and less biased resource deployment decisions, right. We still have centers of excellence around robotics and informatics and other areas that that you want to have unbiased views of how you're going to deploy those resources across the businesses that now exist by having all businesses going to one person. We also want to have clear accountability. So if you're going to make these decisions on resource to plan it, you better have accountability for getting it done and accountability for executing against it. And we're streamlining the organization. We're making it less complex and as a result of doing that you can drive margin expansion, right. So those are the reasons why we've done this. Ultimately it's going to allow us to invest aggressively for growth while expanding margins and managing the business more effectively. So that was the purpose behind it. And then Suky, if you to want to give some additional detail?
Suketu Upadhyay:
Yes. Sure. So Richard, you're thinking about the right way. There are a number of initiatives and they're going to be cadence of different times. Just based on sort of complexity and time it takes to get some of initiatives up and running. In the early days, I would say it very much is about blocking and tackling and some of the low hanging fruit that you sort of referenced. One, we took a complete cost taxonomy of the organization and we looked at that cost taxonomy relative to that spending versus external benchmark relative to internal benchmark relative to our growth opportunities in our markets and our businesses. And that's leading to quite frankly a mixed shift and a lot of our spending but also some very clear areas of opportunity to reduce spending in lower value areas. Blocking and tackling things like T&E procurement, just basic costs down, again, blocking and tackling. The second area, that's more near-term Bryan talked about the reorganization some of our business units that's leading to efficiency. It's leading to efficiency by de-layering the organization. So we're putting our commercial leadership closer to our customer and closer to the patient. And it's also leading to some reductions and redundancies. So those are we call no regret moves because they lead to margin expansion, but also make the organization more efficient and effective. Longer-term, we're also putting things into place. It's going to take some while for those to mature and bear fruit. But it's around consolidating a pretty fragmented footprint. When you think about the two companies, Zimmer Biomet coming together and then follow on acquisitions and some of the focus that the company has had to spend over the last few years on supplying quality remediation. We can now start to turn the corner from stabilization to efficiency and start to think about how do we consolidate some of that footprint and make ourselves more efficient. And then of course there's going to be some opportunity in the longer-term around centralization of back office and G&A type functions. So those are just a few examples, there are several other initiatives or a number of initiatives as we've talked about going on in manufacturing supply chain, which we think over time after we've stabilized gross margins can lead to some modest improvement in gross margin as well. So hopefully that gives you a little bit more color as to how we're thinking about it and how we're approaching it.
Coleman Lannum:
Thanks for that Rich. Next question please, operator.
Operator:
We'll take our next question from Matthew O'Brien with Piper Sandler.
Matthew O'Brien:
Good morning. Thanks for that question and Cole good luck in the future. Bryan, I was hoping to talk a little bit about ROSA, over the last maybe four or five years here, you've lost about 400 or 500 basis points of Knee share. So I'm curious on the ROSA side, and I know it's early, but you talk about this massive funnel? Can you talk about what you're seeing in that funnel in terms of is it just more people that have been using Zimmer over the last several years and have been good customers or is it a majority of those people that are in the funnel right now are have you been surprised by the number of folks that you've worked with in the past that have come back into the funnel and could be customers here in the near-term again or even just de novo people that’s you've never worked with in the past? If you could kind of wait, where some of those clinicians would kind of stay within those three buckets? I think that'd be helpful. Thank you.
Bryan Hanson:
Absolutely. It's kind of a mixture, when we put the strategy in place, it was pretty clear that our first intent was to go after those accounts that are already using us. The folks that know and love our implants, I've always had an interest in moving into robotics, but wouldn't do it if they couldn't use their own implant. So there's no question that that's a pretty big element of our success. Just pursuing those that love the implant of Zimmer Biomet and now can use that implant in concert with robotics, but what we're finding is that it's never a perfect world in the way you rolled out a plan. And there are situations that are competitive where we know accounts that we would not have pursued in the first place are actually active in looking at robotics. So naturally, as a result of having a robotics solution, we get involved in that process. And we have found that in those competitive situations, even where we didn't have the primary strength in the account, we're winning some of those decisions. And so as a result we are actually seeing conversions being a part of the placement that we see with ROSA. So it's kind of both. And then on top of that, we're also finding, which I kind of referenced before, is once we do get a robotic system in place. Even in an account that is one of our platinum accounts, one of our big users, there's always individual surgeons that are using competitive implants and if they want to migrate to robotics, there's obviously a natural gravitational pull to do that. But they have to use our implants. And so that was what I was referencing before. I was just in an account where five surgeons that were using competitive priority using competitive implants or now getting trained on robotics want to begin using robotics, which is great because that will drive conversions, but it will also drive demand for another robotic system because that's going to get tapped out pretty quick. So again, it's a combination of those things. Also I make sure that we recognize that there's multiple ways to drive revenue when we do place robotic system. The obvious upfront capital purchase is clearly an opportunity for us. You get a mixed benefit, kind of a share of wallet benefit because there is an increased price associated with the disposables you need to do a robotic procedure and then you get that natural pull through that I just referenced, where you get competitive conversions to be able to use robotic system. So again, it's all coming together. I mean, in fact it's early. We're rapidly training and getting these things out there and building the commercial infrastructure to be able to support demand. But it feels good so far.
Coleman Lannum:
Thanks for that Matt. Operator, next question please.
Operator:
Our next question comes from Larry Biegelsen with Wells Fargo.
Coleman Lannum:
Good morning, Larry.
Lawrence Biegelsen:
Hey, Cole. Thanks for taking the question. Just on the ROSA pipeline, just a question on that. Bryan, I heard you talk about hip coming soon. So could you give us an update on the hip, knee, and revision knee, are those 2020 approvals and if ROSA wants spine still in early 2020 launch? Thanks for taking the questions.
Bryan Hanson:
Yes. So I would just take a quick step back and just let you know that there's been a pretty significant shift of focus in the organization. We've done a very good job of rethinking how we deploy resources inside of research and development, and commercial infrastructure by the way. But we've really taken a hard look at the R&D pipeline, started to get more bias towards robotics and informatics and spend significantly more money, almost the mix shift that has occurred in those areas. It doesn't mean that we're not going to continue to do implants. But the fact is most of the money now is shifting, a good portion of that money is shifting towards ROSA, towards a mini robotics, towards informatics, towards efficiency in doing the procedure. So that was a pretty significant innovation shift for the organization because we think it could bring real value to the patient and the customer. So that was a big shift that occurred. As a result of that, we now have more in the pipeline in applications for ROSA in other areas. And so the next things that you're going to see from ROSA that we've been very transparent about this is a partial knee application as well as the hip application. Those will likely come in 2020, but I don't want to give specifics. You'll learn more about these at the AAOS meeting. But those are the next in line. Revision is something that we're clearly working on. We have an opportunity to be able to do this because we don't need a CT scan to be able to use the robotic system, opens the door for our Revision procedure. But that's a challenging application to provide, would be a big window because it's one of the most challenging procedures to do. So if you could have robotic assistance inside of that, it would be attractive. But I don't want to give a view on timeline for that. So again, we're shifting dramatically our innovation pipeline to those very important elements of the ecosystem that are around the implant. We don't lose focus on the implant, but we just – we enhanced our capability to bring the implants to the market in a way that helps patients and customers more.
Coleman Lannum:
Thanks for that Mr. Biegelsen. Next question please.
Operator:
Our next question comes from Matt Taylor with UBS.
Matthew Taylor:
Hi. Thank you for taking the question. So I just wanted to clarify one thing on this operating margin guidance. When you talk about the 30% in 2023, is that the full-year number? And the reason I asked is because if we use the midpoint of this year that does imply higher than that 50 to 70 bps beyond this year over that timeframe. And I guess I was wondering if that's right, and what has to happen on the topline for you to achieve that?
Bryan Hanson:
I'd say it's interesting because we're talking about 30% and 30% of our questioners have been – Matt. But I'm sorry.
Suketu Upadhyay:
Yes. So you're thinking about it correctly, Matt. It is 30% in-year in 2023. Again, as I said earlier in call, it's not going to be – we would not expect the cadence to be linear. It could happen sooner. It could be more in the back end of that period depending on topline growth and our level of investment back into the business. And I'll come back into that. You're right. Relative to 2020, the midpoint would not suggest any significant margin expansion on an operating margin level. And that's consistent with how we've talked about the year where we could see some modest improvement in overall operating margin. However, again, coming back to if we see the right opportunities to invest for long-term growth – near-term growth for that matter, we will make that decision and the overall guidance range reflects that optionality if you will around margin expansion or investment. I will say though, I've got confidence and we're early days, but the team is executing extremely well against these programs that we've launched. And I would say that we're going to see margin expansion as early as 2021. But again, I don't know that you can take a linear footprint from today to 2023 and mark 2021 in that way. But we do expect to see some large expansion into 2021.
Coleman Lannum:
Matt, it probably is worth it to expand on that. Just to remind everyone again, we don't guide to midpoints. We guide ranges and that's exactly what Suky is talking about there. I think that's an important thing to keep in mind as we think very carefully about what ranges to give. With that, next question please.
Operator:
Our next question comes from Ricky Wise with Stifel.
Coleman Lannum:
Hey, Ricky.
Frederick Wise:
Some people won't miss Cole, Bryan. Maybe turning to some of the financial perspectives, maybe I missed. So it could be operating cash flow guidance, but obviously the balance sheets made significant improvement over the last 12-month, a year-ago was almost 4x leverage, now you're roughly 2x leverage. Are you where you want or need to be just where you're aiming towards from here? And does this progress on the balance sheet and driving cash flow open the door in some way, should we imagine the door is a little more open to increased growth enhancing M&A in the year ahead? Thank you very much.
Suketu Upadhyay:
Yes. Thanks for the question Rick. So first of all, on 2019, we ended the year at about $1.1 billion of free cash flow. As we move into 2020, we expect that number to be somewhere between $1.1 billion to $1.3 billion, again 2020. And that's inclusive of these restructuring charges that I talked about a bit relative to the restructuring programs that we're initiating. Again, we're saying operating costs or investments for that program will be somewhere between $350 million to $400 million over the time horizon to 2023. We think a little more than half of that will be in 2020. So again, our guidance for cash flow – free cash flow in 2020, $1.1 billion to $1.3 billion. And again that is inclusive of these restructuring charges that we’ll have to take. You're right. We've made good progress on the balance sheet and delevering. We got ourselves to a point where we're just under three on a net debt basis, ending 2019. And relative to our overall capital allocation priorities, we expect to continue to make progress on delevering the balance sheet into 2020. And again that's strong, durable, sticky cash flow generation is a big component of that. The second thing I'd say though is beyond the priority to continue to delever the balance sheet. We are in a better position now operationally, financially, I think strategically as well. Where if we see attractive M&A targets that meet our strategic filters or financial filters, but also maintain a strong capital structure and profile and investment grade, we may decide to invest capital into M&A in 2020 and beyond. So again, organically we expect to continue to delever the balance sheet. But again, we may also decide to deploy some capital towards M&A that meets all of our filters that I talked about.
Coleman Lannum:
Thanks, Rick. Thanks. And we all know that's not the worst you've ever said on an earnings call. So next question please, operator.
Operator:
Our next question comes from Robbie Marcus with JPMorgan.
Robert Marcus:
Thanks for taking the question and nice quarter. Just from the – fine, I was hoping you could give a little more color on the updates with the FDA inspection. What exactly did the new items entail? How should we think about the seriousness of them? And then is this something that can get resolved in 2020? Or do you expect resolution more in 2021 timeframe? Thanks.
Bryan Hanson:
Yes. So first of all, I just want to say anytime that we're talking about interaction with the FDA, quality, patient safety, any of those things, I just wanted to be very clear that we take quality of our products and patient safety as the most important thing we do as an organization. The mission of this company is to alleviate the pain of people in the world and make the quality of life better. That absolutely means that our product needs to do, it's intended to do and keep them safe. So that's the first thing that we look at and we feel very confident we're in check there. The fact is it also shows when we saw the FDA come in that we've made real progress. I mean it's hard to describe because you have not been able to see the factory, but a lot of the same FDA investigators that were there, actually were there from the very beginning. And even for me, when I walk in the factory, it just looks different. It literally looks different, and the culture, the energy in the factory is different and that was recognized by the FDA. In fact is we’ve got observations though. We have eight observations in the factory. I would tell you that all of the observations we feel are manageable and we feel very confident that we can respond to the FDA in a way that's going to be satisfactory to them. The way I look at these things is we already have money earmarked to be able to continuously improve that factory. And the fact that the FDA has given us guidance in the way that they have on where we should focus, it's actually a good thing because if we're going to spend money, I'd rather spend it in an area that I know the FDA is concentrating on. So it's basically a roadmap for us to be able to do that. But I want to reiterate the fact that we feel very confident that we're going to be able to respond in a way that the FDA is going to be satisfied and we're going to be able to continue to move that factory forward. I think it's important to recognize though that this isn't going to be an issue that gets resolved in 2020. It's just not. I mean, the only way you move down a path to remove a warning letter is to have an audit where you have basically very little to no observations, and obviously that didn't happen this go around. And from here it's just up to the FDA and when they come back in. We're going to respond to the observations in a very timely manner, in a comprehensive way, keep that dialog moving with the FDA, but ultimately it's their decision when they come back in. And even when they come back in, if we get a stellar audit and we have very few to no observations, it still takes time to be able to remove a warning letter. So it's just a process that's involved. At the end of the day though, even with the warning letter in place, I just want to reiterate the fact that we can absolutely function effectively out of that factory base. So I appreciate the question that we feel really good about the progress that we're making. Obviously, some work to do still, but we feel confident we can get there.
Coleman Lannum:
Thanks for that Rob. Next question please.
Operator:
Our next question comes from Mike Matson with Needham & Company.
Michael Matson:
Hi. Thanks for taking my question. I guess I just wanted to ask another ROSA question. So I didn't really hear any commentary on the status of the spine and brain version of the robot. So can you maybe talk about the launch plans there and whether or not you sold any in the fourth quarter? Thanks.
Bryan Hanson:
Yes, I appreciate that. We have folks using the ROSA Spine system, but it's really just those that are developers. So we're not in a really a launch mode yet for that system. But if I just take a step back and I think about the Spine business overall, I think about it in a few different ways. We clearly have not been performing the way I would like and we're not performing right now with predictability in that business. There are key areas that we need to concentrate on. The number one thing is we have to get the channel that we've decided on to be able to take advantage of the portfolio that we have. The fact is we have the best cervical disc in the market and we need to make sure that now we're taking advantage of the Mobi-C in the way that we should now that we have stability in the channel. We have the Tether, which is an absolute pivotal change for those with scoliosis. It dramatically changes the care for that patient population, a very exciting technology. But the channel's got to take advantage of that. And we have now gap fillers like the TrellOss titanium 3D printed interbody. That was a major gap for us. We now have that 3D printed interbody that we need to make sure that we're taking advantage of, and we have to launch ROSA, and that's got to happen in 2020. It's not just ROSA though, it's got be ROSA in concert with our mini robotics platform in Walter, because that provides a comprehensive solution for the surgeon when we talked about robotics, not just placing screws, but also being that third or fourth arm for the surgeon and the procedure. All those things need to come together in a predictable way so that we can start turning that business. So ROSA Spine is definitely a part of the equation. It's just not the whole equation and the intent is to launch that in 2020.
Coleman Lannum:
Thanks for that Mike. Next question please.
Operator:
Our next question comes from Ryan Zimmerman with BTIG.
Ryan Zimmerman:
Great. Thank you. So just want to follow-up, Bryan, I heard you loud and clear on the S.E.T. business. And I just want to dig into the components of that between sports, extremities and trauma. Can you just talk about kind of where you're most focused of those three? If we were to kind of parse it out a little bit more than kind of what we've seen thus far? Thank you.
Bryan Hanson:
Yes, it's a great observation. I mean, the fact is, the S.E.T. businesses, although in aggregate, they do grow in that mid single-digit growth area. They're not all created equal obviously. And the whole idea in our organization is to make sure we're disciplined and focus. So as a result of that discipline and focus, we need to make sure that we're picking the most attractive sub-markets inside of S.E.T. And I can tell you its kind of obvious when you look at it. Sports and extremities will be the areas that we focus most on. And so you're going to see a lot of our attention, not just in research and development, but also from a commercial channel standpoint, training and education being focused in those areas. The fact is we already have a significant right to win, and we need to take advantage of that in upper extremities. I want to see us build more scale on lower extremities and absolutely become a market share leader there and we have a lot of traction and opportunity for us in sports. So those are going to be the areas where you're going to see significant investment, significant focus, our operating mechanisms are being built around that and that will be the area that we concentrate inside of S.E.T.
Coleman Lannum:
Thanks for that. Next question please, operator.
Operator:
Next question comes from Josh Jennings with Cowen.
Joshua Jennings:
Hi, good morning. Thanks for taking the questions. I was hoping to just get an update on the salesforce. I know there's different salesforces for different divisions, but just from a high level, can you just share with us the attrition rates you're experiencing entering 2020 or exiting 2019 versus exiting 2018? And then I think you talked historically about the compensation scheme being in place to drive the salesforce coming on offense. Can you just talk – help us understand the nuances to that compensation scheme, and then that was put into effect? Thanks for taking the question.
Bryan Hanson:
I would say it's – we've actually had zero regrettable turnover in the commercial organization. And I always look at it to say if you stuck with the organization through all the hell that occurred over the last number of years and you leave the organization now and the momentum comes. I probably don't watch it in the organization anyway because you're not making rational decisions. But that's playing out. I said it kind of tongue and cheek in the past, but the fact is we've had zero regrettable turnover in the commercial organization. It’s a testament to the fact that people understand momentum is coming, that we have a market leadership position in large joints. We have potential to do the same thing in S.E.T. and we have new products that are coming that get the sales organization excited. And so I just – again, I see that momentum. I feel it. I was in the Asia Pacific kickoff meetings. I felt significant energy there. Same thing in Americas. I'll be in – actually after this event, we'll be heading to Spain for the European kickoff event. And I can tell you the energy is just there. So we're not seeing that turnover. When you see momentum like this and you don't have a critical turnover, it gives you the opportunity to decide who stays in the organization and who doesn't. And that gives us an opportunity to upgrade talent as we go. That will be a major focus of this organization always ensuring we have the best talent, developing the best talent and retaining the best talent.
Coleman Lannum:
Thanks for that Josh. Next question please.
Operator:
Our next question comes from Pito Chickering with Deutsche Bank.
Philip Chickering:
Thanks guys for taking my questions. And Cole, thanks for help over the years. While so early in ROSA launch, I was curious what percent of ROSA knees are being done cementless right now? I'm certain that you use that with knees and robots. Are you starting to convert the non-ROSA knees to cementless?
Bryan Hanson:
Yes. So the cementless opportunity is it's kind of bifurcated. We have an opportunity to be able to convert knees to cementless without ROSA. So we're certainly trying to do that and are doing that. At the same time, when you look at the robotic application, you get such confidence in cuts that typically what you find is people are more willing to go to cementless as a result of having robotics in. So it is a combination of those two things and you would naturally see in robotic cases a higher mix of cementless versus non-robotic cases. But either way, we don't have a lot of robotic systems out there today and we're not slowing down in our pushing of the cementless option because we think it's a very good one. So it's both of those things, right. So we're going to go after conversions and get a mixed benefit for those that are already using our implant with cementless and we're absolutely going to take advantage of robotics to be able to address them as well.
Coleman Lannum:
Thanks for that Pito. Next question please.
Operator:
Our next question comes from Kristen Stewart with Barclays.
Kristen Stewart:
Hi. Thanks for taking my question. Cole, I guess you won’t be missed. I have a question just about the restructuring program in general. So if I'm looking at the pretax savings that you're expecting to be generated, it looks like that contributes pretty much all of the operating margin expansion over the next several years. And then the free cash flow I guess as well. I guess that's also eating into the cash flow, I guess that you're expecting as well. The $1.1 billion to $1.3 billion that you're guiding to. How should we just think about the operating cash flow for the next couple of years, too, because $1.1 billion to $1.3 billion seems kind of flattish relative to where you've been out for the last couple of years? So just trying to understand what kind of the base businesses doing absent this restructuring charge or charges and savings. Thanks.
Suketu Upadhyay:
Yes, sure. So you're right Kristen. If you took the range that we discussed, $200 million to $300 million by 2023, and you dropped all of that margin, you could effectively get to 30%, right. Your math is right on. But I think it's important to understand that that program is not just about margin expansion and through cost reduction and dropping that. It really is more about creating a mix shift and providing us the ability and the confidence to invest against our highest priority opportunities to drive topline growth, right. So I would say the program is more about creating and liberating that funding to drop topline versus just a sheer dropdown into operating profit. So we think it's actually going to be a combination of accelerating revenue growth from where we are today, but also improving overall margins as we leverage our infrastructure and grow SG&A at slower rate than topline. Okay, so that's how we think about overall the margin profile between now and 2023 where we're saying at least 30% operating margin. Relative to free cash flow, again, we ended 2019 at just about $1.1 billion. We do expect to see an improvement into 2020. So our guidance has that profile baked into the $1.1 billion to $1.3 billion. And again, that $1.1 billion to $1.3 billion is burdened by some of these restructuring costs that we said will be $350 million to $400 million over that three to four-year period. Again, more than half of that being in 2020. So the underlying cash flow operationally within the business is in fact improving and improving at a really healthy clip into 2020. And again, as we think about what are our key metrics and financial priorities, revenue growth, margin expansion, free cash flow conversion, we do expect to see an increase and an improvement in overall free cash flow conversion into 2020. So hopefully that…
Kristen Stewart:
Yes. Is that - $1.1 billion to $1.3 billion, is that an adjusted cash flow or is that like a real cash flow number?
Suketu Upadhyay:
No, that's straight cash flow. That's operating cash flow less property plant and equipment and instruments.
Kristen Stewart:
Okay. I'll have another question online. Thank you.
Coleman Lannum:
Yes, let’s do the last offline because we're after the bottom of the hour. So we're going to wrap it right there. Thanks everyone for joining us today. Certainly appreciate it. Keri, Barb and I will be around for the rest of the day to answer any questions you may have. There'll be a replay of this call available on our website posted later on today. Best way to reach us is probably by emails and send us a note if you have any follow-up questions. Have a great day and a great week everyone. Goodbye.
Operator:
Thank you again for participating in today's conference call. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet Third Quarter 2019 Earnings Conference Call. [Operator Instructions]. As a reminder, this conference is being recorded today, November 5, 2019. Following today's presentation, there will be a question-and-answer session. At this time, all participants are in a listen-only mode. [Operator Instructions]. I would now like to turn the conference over to Cole Lannum, Senior Vice President, Investor Relations and IRO. Please go ahead, sir.
Coleman Lannum:
Thanks, operator, and good morning, everyone. Welcome to the Tuesday morning addition of Zimmer Biomet’s third quarter earnings conference call. I'm joined by Bryan Hanson and Suketu Upadhyay. Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please note that we assume no obligation to update these forward-looking statements, even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties in addition to the inherent limitations of such forward-looking statements. Also, the discussion on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within the earnings release found on our Web site at zimmerbiomet.com. With that, I'll now turn over the call to Bryan. Bryan?
Bryan Hanson:
Thanks, Cole. And I want to say again thanks for joining the call today. We delivered, as probably everyone has seen already with press release, a pretty strong quarter for Zimmer Biomet in third quarter with better-than-expected revenue growth driven by improved performance across all of our geographies and across all of our businesses. Our team remains focused and engaged in our key priorities and we continue to make progress in each of these critical areas. Although there is clearly still much to be accomplished, I’m pleased with the team’s momentum thus far. In terms of supply, we have been able to meet customer demand and improve service levels, which further enhances the confidence of our sales teams around the world putting them back on the offense. We still have plenty of opportunity to decrease the complexity and increase the efficiency of our supply chain, but again to give team credit, I’m happy with the progress thus far. Our quality remediation efforts at the Warsaw North Campus remain on track. We continue to keep the FDA updated on our progress and are highly confident in our path to full remediation. To instill further confidence in our progress, we have engaged independent third parties to conduct comprehensive mocked audits of our remediation work and the feedback has been positive. Additionally, we are seeing the benefits of our global rollout of the Quality Begins With Me program, which is focused on driving the solid and sustainable quality culture. This program supports an environment of empowerment and accountability for all of our manufacturing team members ensuring that every individual feels personal ownership of the quality process. Progress we are making in quality remediation is also within the free-up engineering time and allows many of these R&D members to shift back toward innovation. This gives us increased confidence in the robustness of our technology pipeline as we move into 2020 and beyond. Our innovation focus has also shifted moving much more aggressively toward enabling technology around the implant, such as robotics, mini robotics, informatics and operating room efficiency. Although the implant will always be at the center of what we do, our goal is to provide a complete ecosystem that is both customer and patient centric. To this end, we are excited about recent launches like ROSA Knee, mymobility developed in partnership with Apple, our Walter mini robotic platform, the Signature ONE Planner for upper extremities and increased focus on our efficient care pre-surgical planning process. Relative to mission and culture, we’ve continued to focus on communicating and driving the mission of the organization as it is the primary reason we all wake up in the morning to come to work. Every team member is essential to driving our mission which is to alleviate pain and improve the quality of life for people around the world, and our team members take pride in knowing that our products improve a patient's life every 10 seconds; that’s 24 hours a day, seven days a week. We are also relentlessly focused on driving a winning ZB culture. We recently rolled out our culture of promises. These promises of shaping tomorrow, igniting collaboration and focusing to win are inspiring and actionable. Each comprises a set of practices to empower the team at every level in the organization to collaborate and innovate with an emphasis on the future, while working with clarity and focus to maximize our impact today and to deliver on our commitments. Speaking of delivering on commitments, let’s turn to third quarter results. All three of our geographies performed well with strong performance in Asia-Pacific and EMEA and improving performance in the Americas. Relative to our businesses, we are pleased with the performance of the knee franchise this quarter with solid results across all three regions. I know that everyone is interested in hearing more about ROSA Knee, so to give you a bit more color, ROSA capital sales were strong in the quarter and accelerated from Q2. Our ROSA Knee customer pipeline continues to grow and is very strong and the feedback remains extremely positive. To provide some context around ROSA's contribution to the third quarter global knee number, while ROSA was a strong contributor to the quarter, more than half of the overall growth came from other new products inside the knee and our base knee business. Even though we're early in the process, the team is very pleased with the ROSA launch and the overall momentum we are seeing in the robotics market. In addition, we recently received FDA clearance for the Persona Revision system, now rounding out our flagship Persona Personalized Knee offering. Our S.E.T. business delivered solid growth in the quarter, again fueled by growing confidence from the sales force due to supply stability, new product launches across these businesses, increased traction in the specialized sales channel and a much more intense operating mechanism focused on driving results in this space. We will continue to prioritize innovation and accelerate the expansion and investment in our specialized sales channel in order to further increase our focus and traction in these higher growth S.E.T. markets. I’d like to congratulate our dental team for another positive momentum quarter. The team’s focus on strategic priorities, execution and culture, along with target investment in key areas continue to drive the business forward. We still have much to prove in this business, but I’m happy with the current momentum and the performance of the dental team. Relative to our Spine & CMF business, although we did see improvement from Q2, we continued to perform below market in the quarter. As we have previously stated, we don't expect to see real momentum shifting in this business until sometime in 2020. The primary drivers for this shift will be working through the final steps of our channel consolidation in spine and leveraging our new product pipeline, including the recently launch of the TrellOss titanium 3D printed interbody system, the upcoming launch of robotics with ROSA, spine and Walter and the recently approved Tether system. Actually, the FDA approval of the Tether, an innovative treatment for young patients with scoliosis, was a highlight in the quarter for the spine business. This approval marks the culmination of multiple years of cooperation between the FDA and Zimmer Biomet and represents the first approval for humanitarian use device in spinal pediatrics in the last 15 years. So as you can see, we’re making steady progress shaping the future of this organization. We have built the strong foundation and with every quarter, we have continued to reduce the risk in the business and further our progress toward reshaping Zimmer Biomet for sustained success. And with that, I’ll turn it to Suketu to get further into the numbers of the quarter.
Suketu Upadhyay:
Thanks, Bryan. To reiterate, we had solid revenue growth in the quarter but also saw strength in earnings and cash flow generation. I'll provide some highlights on our third quarter financial results and unless otherwise noted, the numbers I will be discussing are on a constant currency basis. Net sales totaled $1.9 billion in the quarter, a reported increase of 3% over the prior year and an increase of 3.9%, excluding the impact of foreign currency changes. As we’ve previously noted, the first half headwinds from billing days was offset in the third quarter and there's no material impact on our growth rate from billing days differences for the full year. During the quarter, we had solid results across all geographic regions. Our Asia-Pacific team delivered strong performance with 8.8% sales growth driven by continued strength in emerging markets and across our Knee and S.E.T. segments. Our Europe, Middle East and Africa team also had strong a quarter with 4.8% revenue growth led by S.E.T. and improvements across our Knee and Hip franchises. Developed and emerging markets within EMEA both performed well due to healthy market growth and as a result of some tender wins. The Americas increased 2.3%, reflecting improved performance across most of our product categories driven by new product introductions, supply stability and commercial execution. Our Knee franchise grew 4.9% with solid performance across all geographic regions. Hip grew 4.3% and our S.E.T. and Dental businesses grew 6.2% and 3%, respectively. Our Spine & CMF revenues decreased 1.3% in the quarter. As it relates to revenue in the fourth quarter, foreign exchange rates have been a headwind since our last guidance update and we now expect the impact of foreign exchange in the full year to be closer to the high end of our range. Also, while revenue growth may be lumpy from quarter-to-quarter, our continued supply stabilization, improved execution, a new product introduction give us greater confidence in our ability to deliver consistent constant currency sales growth in line with our weighted average market growth of 2% to 3%. Moving to the income statement. We reported GAAP diluted earnings per share for the quarter of $2.08. After accounting for special items, our adjusted diluted earnings per share were $1.77. A reconciliation of reported earnings per share to adjusted earnings per share is included in this morning's press release. Adjusted gross margin the quarter was 72.4%, an improvement of about 80 basis points from the prior year, which was aided by a number of items, including a medical device tax refund that we referenced last quarter. Gross margin the quarter was broadly in line with the first half of 2019, despite seasonally lower revenues. Adjusted operating expenses in the third quarter were higher than the same period last year, driven by increased investments across R&D and commercialization efforts, including spending on new product launches and sales force expansion. Adjusted operating margin was 26.5% for the quarter, about 90 basis points ahead of prior year driven by gross margin and the adjusted effective tax rate was 16.5%. All of this translated into 8% plus growth in adjusted earnings per share demonstrating good earnings leverage on revenues. Operating cash flow accelerated in the quarter to $578 million and our free cash flow was $425 million. During the quarter, we paid $49 million in dividends and paid down just over $300 million of debt as we continue to make progress in delevering the balance sheet. Relative to our capital structure in light of upcoming maturities and market conditions, we may look to opportunistically refinance debt to optimize our liquidity profile and cost of capital. Before I turn it over to Bryan, I’d like to reiterate that we are pleased with our performance in the quarter and our previous guidance remains unchanged. And with that, I’ll turn the call back over to Bryan.
Bryan Hanson:
Thanks, Suketu. Before we move into Q&A, I also want to take some time to say that this is clear to me and I think really to the team here that our team members in general have a really high energy right now, the engagement is high and the focus to win is there, and I'm confident as a result of that it’s going to allow us to move forward and progress in the right manner. This is one of the primary reasons why our confidence level is very high around consistently and durably delivering 2% to 3% top line growth through 2020. And for many other reasons and I want to make sure I’m clear on this, over time I also see a pathway for acceleration beyond 2% to 3% without the need for M&A. This will take time but the pathway is clear to this team. Of course, our goal at the right time, in the right spaces and for the right returns is to further enhance this organic revenue growth with inorganic activity focused on increasing our growth rate and increasing our weighted average market growth rate. And with that, I’m going to turn it back to Cole and we can jump into the questions.
Coleman Lannum:
Thanks, Bryan. Before we start the Q&A session, I want to remind you to please limit yourself to a single question with a brief follow-up if needed. Feel free to put yourself back in queue afterwards. I promise we'll get through as many questions as we possibly can. With that operator, can we please have the first question?
Operator:
Thank you, sir. Ladies and gentlemen, at this time we will now begin the question-and-answer session. [Operator Instructions]. Our first question comes from Larry Keusch with Raymond James.
Larry Keusch:
Thank you. Good morning, everyone. Bryan, just given the announcement of the Wright acquisition by Stryker yesterday, could you talk a little bit about positioning of Zimmer’s extremity business and any touch on the growth and investment strategy there?
Bryan Hanson:
Yes, absolutely. It’s not surprising to me that we saw that activity out in the market. Let’s face it. When we think about our S.E.T. businesses, we’ve been talking from the very beginning that this would be an area of concentration for us. For the most part, we have lower penetrations in these markets. They’re faster growth than our core large joints markets and as a result of that they’re attractive. So not surprised to see others move in that direction as well. We’re going to continue our focus as well. A fact is if I look at the S.E.T. business overall for the quarter, it was pretty good performance for us. And to be honest that needs to continue. We need to continue to see at least market growth if not the high end of market growth in our S.E.T. businesses to be able to allow us to get scale in these spaces and ultimately as a result of that increase our weighted average market growth. So you will absolutely see us continue to focus here. And we’re going to focus in a number of elements. First and foremost, we have to make sure that we keep our supply stability in place. As I think everybody probably remembers, it took us a little longer to get supply stability here because we focused on large joints first, but we haven’t now and that is absolutely increasing the morale of the organization and that needs to stay there. We’re going to be launching new products. We already have. We’re going to continue to do so. We have a full pipeline. And these new products I think as everybody knows also drives morale and traction in the field sales organization. That’s going to be an element of focus for us. And I got to tell you, with some of the new team members that we have, this idea of changing the operating mechanisms to be much more disciplined and much more focused, much more transparent on whether you are or not performing in the area will drive accountability in the space. And then a big one we’ve been talking about, which I think we’re making advances on were to be the specialized sales organization, so we have focus. I got to say I think personally we still got some work to do here. To me specializing the sales organization is just step one. You also have to make sure that you have the right compensation structure in place and right operating mechanisms so that those specialized sales reps actually stay focused. A lot of times what you see is that when large joints takes off, those specialized reps go back to large joints because they can make more money there. We can’t allow that to happen through our compensation scheme and also our operating mechanisms. So again, I see the S.E.T. space particularly with extremities being very attractive. We will continue to focus in this area and I’m not at all surprised to see the activity that we just heard about.
Larry Keusch:
Okay, great.
Coleman Lannum:
Thanks, Larry. Go ahead, Larry.
Larry Keusch:
I was just going to say just to clarify there just robotics in extremities, is that a focus for you guys?
Bryan Hanson:
We haven’t gotten into specifics there, but one could certainly look at robotics application in large joints and believe that there would be an opportunity for us to move those applications to other areas. I don’t want to get into the specifics obviously for competitive reasons, but there would be no reason to believe that robotic applications or informatics couldn’t benefit extremities as well.
Coleman Lannum:
Thanks, Larry. Next question please, operator?
Operator:
Our next question comes from Steven Lichtman with Oppenheimer.
Steven Lichtman:
Thank you. Good morning. I imagine you’ll get a lot of knee questions understandably. I did want to ask about hips. It had a nice pop I thought sequentially even in taking into account the extra selling day. Can you talk, Bryan, about that franchise? What’s driving it and your outlook for that hip business overall?
Bryan Hanson:
Yes. I was thinking the same thing. I know we get a bunch of knee questions and ROSA questions and everything else, so I appreciate the hip question out of the gate. I appreciate that, Steve. So I’d say is I’m pretty happy with the hip performance in the quarter. Obviously we had the day benefit. We have different billing days which benefitted all our businesses. I’m not going to repeat that over and over again, but it helped. But even without that, it was a solid hip quarter for us. And we like to see those. It’s interesting that when I look at the hip business, over the last number of quarters what I found is it’s a little bit lumpy. We’ve had some quarters that have been on the low end of market growth, even some below, some right square in the middle and some above. But I think generally speaking, the way I view the hip business for us is to be growing at market, which is that kind of low-single digits market growth. What could change that over time would be really two things that we’re going to be concentrating on. Number one and this is more real time is the launch of the Avenir Complete which I think everybody knows at this point is the new short stem colored version of the Avenir as surgeons [ph] know and love that can be used more for that anterior approach procedure in hip. That actually is one of the fastest growth subcategories of hip, so obviously that’s a reason why we’re going to be concentrating in that area. So as we get more traction with that launch, more education for surgeons so that they can do that procedure well and ultimately begin to drive scale with that product launch, that’s going to help us get strength in hip over time. I never want and I’m not going to speak to specifics will be the eventual application in ROSA that would also be applied to hip. I think the combination of more scale in that anterior approach procedure, a ROSA-launched application that will be coming in the future, combination of those two things will allow us to get to that upper end of hip growth if not above the overall market growth in hip. But I want to be clear. In the short term, I’d be thinking about our hip business, that market growth and the longer term as we launch some of those other products and build scale that I referenced potentially above market growth.
Coleman Lannum:
Thanks for that, Steve. Lauren, next question please?
Operator:
Our next question comes from Chris Pasquale with Guggenheim.
Chris Pasquale:
Thanks. Congrats on a nice quarter. Bryan, you mentioned the knee growth was really multifaceted beyond just the impact of ROSA. I was hoping you can give us a little bit more color on some of the drivers there? How much of an impact is Persona Cementless having on your business at this stage and how meaningful an addition is the new Revision system?
Bryan Hanson:
Yes. First, I’ll hit the Revision system. We didn’t have revenue in Q3 on the Revision system, but what’s interesting is that there was a lot of hype around the Revision system coming, and that’s important because it drives excitement in the field. Because there are a lot of surgeons that had been waiting to move to Persona until they felt comfortable we would have a Persona Revision system. So the fact that it didn’t provide any revenue didn’t change the fact that it did create some hype in the marketplace in Q3. So outside of that I’d just say, the major reasons for the strong performance in knee that we saw, number one, and I’m going to keep repeating this because I think it’s really important. We are seeing the morale of the commercial organization shift and shift in a meaningful way. And that puts them back on offense which is exactly where we need them to be, hence our new products. Obviously ROSA was a big part of the quarter. I already referenced that in the prepared remarks and it continues to be an engine for us, will be an engine for us as we move forward. And then all of the Persona launches that we’ve had, not just in the Revision system we just talked about but our Partial Persona and our Cementless Persona were very important parts of our total package there. And then again, I’m going to just keep repeating this as well. We have a much more disciplined approach to driving the operating mechanism of running the commercial organization. And that is creating an environment where we do what we say. And if we don’t do what we say that there’s accountability to that, there’s transparency to it. So all those things kind of came together to be able to drive a strong quarter. I do want to reference when I think about Cementless since you asked about that. The fact is we’re getting great feedback on all of our new products and we are getting great feedback on the Cementless version of Persona as well. And over time I expect to significantly increase the penetration of Cementless knees with the goal of achieving similar penetration rates to some of what our competitors have been saying they’ve been able to do. I think ROSA being out there given the accuracy in the cut should increase our ability to get Cementless penetration. And I think just the shift and focus by the sales organization is going to drive it as well. I do want to make sure that I just clarify something. When I talk about the penetration of Cementless moving to these higher percentages, it is the Persona Cementless, so it would be a percentage of the Persona family not the total knee but clearly it is a growth driver that we’ll be leveraging inside the knee.
Coleman Lannum:
Thanks for that, Chris. Next question please?
Operator:
Our next question comes from Pito Chickering with Deutsche Bank.
Pito Chickering:
Thanks, guys. It looks like I’ll be the leadoff on the ROSA questions. Thank you for giving us those details on the call. If half the worldwide growth of knees came from ROSA, that implies that $15 million of ROSA sales. So looking at America knee growth, does that mean that U.S. consumables was about 384 million or flat year-over-year? And then embedded within guidance, how should we think about ROSA sales in fourth quarter versus core America’s consumable growth?
Bryan Hanson:
Yes. So we didn’t say half. I just want to make sure that I clarify that that we said less than half of the global knee revenue came from ROSA. So again, a material impact to the quarter but it was less than half of the total revenue number. And I don’t want to get into specifics of sub-region, growth profiles and certainly don’t want to give any predictions of what we do in the fourth quarter. I think probably the most important thing though to think about when we think about ROSA is that the demand is high. I’m very excited about what we’re seeing in the field. I’ve mentioned a number of times in my entire career in med tech, I’ve seen certain product launches really get the attention of the market and shape things. It’s only been a handful of times. This is one of those times. This is exactly what we’re feeling. It’s early days, but there is no question the demand of ROSA is very high. And the beautiful thing about this is that as we place more ROSA systems, which will happen over time, you get this annuity revenue, you get the instruments revenue, you get the service revenue, you get pull-through of competitive implants as well and that’s exciting because it gives us a more predictable view of what our knee franchise is going to be able to do over time. So I’m pretty excited about what we’re seeing so far. I do want to make sure that I clarify something though and this is just something that truly is becoming more clear to all of us. The annuity revenue stream that I just talked about, it does take time to materialize after you make placements of ROSA, sometimes a quarter or even two quarters to really get a good trend going from those placements. So I truly expect that the base knee business will take some time to create positive inertia as a result of the ROSA placements and ultimately that’s got to offset some of the negative inertia that we have from our competitor getting there much earlier than we did. So as much as I’m very enthusiastic about the demand for ROSA, it will take time to have that resulting impact on our base knee business. But again, couldn’t be more happy with what we’re seeing right now. It was an important part of the quarter and we would expect it to continue to accelerate into 2020.
Coleman Lannum:
Thanks for that, Pito. Next question please?
Operator:
Our next question comes from Kristen Stewart with Barclays.
Kristen Stewart:
Hi, guys. Thanks for the question. I just wanted to ask a question on just margins. I know this quarter you had a bit of a benefit from FX hedges flowing through gross margins. You also had the benefit from the medical device rebate tax. How should we just think about margins as we look ahead? I know the device tax could eventually come back. I’m not sure how that would eventually flow through the impact. I don’t know if it will even hit next year or if that’s something that would hit the year after just depending upon how the inventory kind of flows through. How should we just think about kind of trends looking ahead? I know you guys have talked about trying to see some level of operating margin improvement next year, although I think you’ve said gross margins next year could see some pressure. Just trying to gauge, I know you don’t want to give 2020 guidance obviously, but just directionally how are you thinking about margins maybe even not so much next year but also just looking ahead as you guys think about just the cost structure of the company? Thanks so much.
Bryan Hanson:
Thanks, Kristen, for I think the longest question I’ve ever heard on an earnings call. Let me turn it over to Suke.
Kristen Stewart:
I learned that from listening to you, Cole.
Suketu Upadhyay:
Hi, Kristen. It’s Suke. Good to talk to you again. So let try and take your question. I’ll start with the near term and then weave it into 2020 commentary. So I think the first thing to understand is where the company’s come from? And I think if you look back over the last four years, the company has contracted gross margins and operating margins close to the 400 to 500 basis points. So as we think about gross margin within the quarter and actually over the last several quarters, it’s great to see that we’re actually stabilizing even in the backdrop of continued price erosion that the industry faces. Our gross margin was better than prior quarter or prior year I should say by about 80 basis points for many of the reasons that you talked about. And the good thing is that it flowed through down into operating margins which were about 90 basis points ahead. In fact, this is the first quarter in several quarters where we’ve actually shown operating margin expansion. So again, given where the company has been, I think this is a good proof point. It is one quarter and we got many more to prove that consistently over time, but we’re really happy with the progress that we’ve made in sort of stabilizing supply and now starting to pivot towards efficiency. As we think about the rest of the year into the fourth quarter, as we said, we’re going to maintain our overall guidance range. And so our view on gross margin, operating margins are consistent that ultimately underpinned that guidance update that we gave at the last quarter, so no material changes there. As we think about 2020, our commentary is consistent with what we said before. While gross margins are a bit better this year and we feel really good about that, a lot of good progress, there are some headwinds as we move into 2020. We’ve talked about a few things there which are some of the cost increase and investments in getting to stabilization in supply ultimately get capitalized on the balance sheet and flow through cost of goods sold as that inventory turns. And as you know we have close to a year of an inventory which is another challenge and an opportunity we have in front of us. But those defer or capitalized cost will flow through at a higher level into 2020, so that’s a headwind. We have the medical device tax one-time gain in this quarter that will not repeat next year. Of course, pricing erosion continues to be a headwind into next year. And FX hedge gains this year will be stable. So you won’t see that as a tailwind or a headwind, but you won’t see that as a tailwind as you saw in '18. Now having said that, there are a number of tailwinds as we go into next year. One, Bryan talked a little bit about Cementless, right, and we have other products that from a mix perspective have the benefit to gross margin. So we see that as a positive. We’re also in process and also kicking off a number of cost-down initiatives across our manufacturing network and our supply chain. So that will start to yield benefit over time. However, in 2020 specifically, those headwinds more than offset the tailwinds. However, beyond 2020, we would start to see those tailwinds become more prominent. So that’s a little bit of gross margin commentary. Again, very consistent with what the company has had before. Now despite gross margin headwinds into 2020, we still project that we’d be in a situation where we can generate some modest or slight level operating margin enhancement primarily driven by better revenue growth and more consistent revenue growth in that 2% to 3% range. Now having said that, we are also very excited about many of the new products we’ve launched, the morale in the company, the opportunity to accelerate top line, if we see the right opportunities to invest at a higher level to accelerate the top line, we may chose to reinvest that margin enhancement in 2020 to grow the top line, because we all know that driving long-term durable above market growth rate is the best path to margin expansion. So, again, our commentary on 2020 gross margins – sorry, operating margins remain consistent with where we were. So thanks for the question. A great quarter. Hopefully, we string a lot more of these together in the future.
Coleman Lannum:
Thanks for that, Kristen. Next question please?
Operator:
Our next question comes from Kyle Rose with Canaccord.
Kyle Rose:
Great. Thank you very much for taking the question. Bryan, I just wanted to circle back on the S.E.T. business. I appreciate the color in the previous answer, but I guess maybe just help us understand what stage of the investment cycle are you in with respect to the specialized sales force in the S.E.T. business? And then any plans to potentially accelerate those investments just given you’ve got some potential market disruption over the course of the next 12 to 18 months with the acquisition?
Bryan Hanson:
Yes, you’re reading our minds I think on that one. I would say we’re in the early innings of a robust look at specialization done the right way, because as I referenced before, it’s not just specialization, it has to be in tandem with better compensation structures so that you’ve got the right incentives in place and the right operating mechanisms to ensure that you keep that focus. So I’d say we’re early innings and we are moving as far as we possibly can to get to the late innings. And we do believe that just by the very nature of integrations in our space that there will be some disruption in the extremities market and we certainly want to make sure that we take advantage of that.
Coleman Lannum:
Thanks for that, Kyle. Next question please?
Operator:
Our next question comes from Josh Jennings with Cowen.
Josh Jennings:
Hi. Good morning. Thanks for taking the questions. I was hoping Bryan just to get a little bit more about how the ROSA launch has evolved and any incremental color you can share just about how you build out the sales force, any items around placements versus capital sales? And then just what should we expect in terms of the data accrual pathway, any cadaver data that should be coming out soon or anything that we – acute data that we could see from any of the early adopters at AAOS? Sorry, a multipart question but thanks for taking it.
Bryan Hanson:
Yes, no problem at all. ROSA obviously is a big focus for all of us and we’re all very focused on making sure it goes well. I would just tell you that generally again the feedback has been positive. We’ve been very aggressive in adding commercial infrastructure. When I think about ROSA and I think about capacity, I think about it in manufacturing, I think about it in commercial footprint, I think about it in education capability and in service. All those things need to be in place so that we can move aggressively to play through robotic systems in the correct way. And I can tell you that we’ve been moving very fast in each of those buckets to make sure we have the right capacity. Just from an example, just in a very short period of time we’ve added another 60 reps that are dedicated to selling capital not just ROSA Knee, but other parts of our capital as well, but a lot of their focus right now is in ROSA Knee. We’ve done a lot to train surgeons too, believe me. We’ve been increasing our capability through the semis that we have that can go to your location and train you and other hard locations where you can get the training done as well. And so we’ve gotten now in the hundreds of surgeons that have been trained, which is a very important part of moving the needle forward. And now we have close to 2,000 cases that have been done out in the real world with ROSA and that feedback continues to be strong. So again, very happy with the progress that we’re making so far in building the capacity to do this the right way, and we fully expect that to continue as we move into 2020. This will be one of the primary growth engines of the organization. We will absolutely make sure that we do it right.
Coleman Lannum:
Thanks for that, Josh. Next question please?
Operator:
Our next question comes from Jeff Johnson with Baird.
Jeff Johnson:
Thank you. Good morning, guys. Can you hear me okay?
Coleman Lannum:
Yes, Jeff. Go right ahead.
Jeff Johnson:
All right, great. Good morning. So, Bryan, I wanted to focus maybe on pricing. In the quarter it was down a little bit more than we’ve seen in both the Americas and on a global basis. With especially the mix of knee products we’re seeing launched, our assumption had been and still is that pricing should actually get maybe a little bit better for you guys going forward. But just wanted to check kind of more your forward outlook on pricing I guess but also some explanation on what happened in the third quarter? Thank you.
Bryan Hanson:
Yes. I really try to stay away from thinking too much about what happens in an individual quarter on pricing. There’s just so many different variables involved in it. If we got all worked up about a specific quarter up or down, we’d be wasting a lot of our time. What I would tell you is that I don’t see anything fundamentally from a pricing perspective in knee or otherwise that has me concerned. I still think of that 2% to 3% being pretty consistent overall for our business with negative pricing pressure. I would agree with you though and again it’s going to take time to be able to prove this out, but one would assume as we get better at placing robotic systems, as we get better at doing longer-term contracts with the ZB Connect organization that we put in place which is really a corporate sales organization, one could assume that at some point with those contracts in place you could stabilize pricing and potentially begin to offset some of that headwind. I don’t want to get ahead of us here. I don’t want to get over our skis on that, but that would certainly be a focus of the organization to try to retard some of that pricing pressure by doing longer-term contracts that are good for us and good for the customer.
Coleman Lannum:
Thanks for that, Jeff. Next question please?
Operator:
Our next question comes from Craig Bijou with Cantor Fitzgerald.
Craig Bijou:
Good morning, guys. Thanks for taking the question. Maybe a follow up on the acquisition that was announced yesterday. You guys have said that as you’re stabilizing the business, you’re at least now more willing to look at M&A. So if the business is stabilizing, you’re paying down some debt. So I want to get your thoughts on what you’re seeing out there in the market, namely availability of assets, valuations? And then how we should expect you guys to use M&A to bolster the existing businesses through tuck-ins or even potentially expand the offerings beyond your core today?
Bryan Hanson:
Okay. Well, I’m glad that somebody saw that acquisition out there, so we appreciate you bringing that up. So what I’ll tell you is I’ve been pretty clear from the beginning. I think the team has in general that we really wanted to get into M&A but do it in a way that was logical. First and foremost, we wanted to make sure that we stabilize the core business. That was an important part. You don’t want to distract an organization when they’re trying to get their feet underneath them. And the fact is we’ve done that. We do feel that we’re moving in the direction of stabilizing the core business. We’ve also assembled what I would define as a much stronger M&A team and have begun to establish a new M&A process and an integration playbook or workbook, if you will. And then we’re moving in the right direction when it comes to paying down our debt ratio. So when you just combine those things, it clearly states that we’re in a better position today to be able to look at active portfolio management than we were even six months ago. So one would expect us to be much more focused in this area as we move forward. What I’d also say is let’s face it. As a team, as ZB in the past, we have not had the best track record when it comes to M&A and I certainly feel that we have the right team in place today, the right process to change this, but our preference out of the gate is to kind of the test the team with tuck-in acquisitions in spaces that we actually have the right to win. Now once we’ve proven that we can accomplish these types of acquisitions, then we’d start to think about potentially larger acquisitions or more diversified acquisitions, things that would diversify us further into new spaces. But that said, as a caveat, I just want to make sure that you know if the right asset that was larger or more diversified than what I’m referencing came along, it has strategic fit, it had good return metrics, we would certainly look at it. But the plan would be to do those tuck-ins, test the system a bit and make sure that we play in areas that we have a higher chance of winning. Suke, do you have anything --?
Suketu Upadhyay:
Yes, I was just going to say, Craig, just building off of what Bryan said, I think the company’s capital structure supports that view as well. We continue to make progress in paying down debt and delevering the balance sheet. Our very strong stable cash flows as a company also put us in a position to give us strategic flexibility. And as Bryan – we often look at does the deal potentially meet strategic hurdles, financial hurdles but then we also look very closely at the overall leverage impact of those transactions and we’d want to make sure that anything we enter into gives us the glide path to maintain that investment grade over a reasonable period of time.
Bryan Hanson:
If you think about obviously the deal you were referencing kind of tongue and cheek, that’s obviously a bit bigger of a bite than we’d be looking to take out of the gate. Clearly, a space that we’re interested in but that wouldn’t be the size or scope of a bite that we would take right out of gate here.
Craig Bijou:
Thanks for the color, guys.
Coleman Lannum:
Thanks, Craig. Next question please?
Operator:
Our next question comes from Bob Hopkins with Bank of America.
Bob Hopkins:
Thanks and good morning. So, Bryan, I was wondering if I can just get you to comment a little bit on your core hip and knee markets because even excluding the selling day, it seemed like all of the four largest players in orthopedics saw a nice underlying organic acceleration in hip and knee growth in Q3. And I’m just wondering, is there anything going on in the market worth commenting on or is this just a strong economy and good utilization? Any thoughts there I appreciate it.
Bryan Hanson:
It’s so hard to say. First of all, thanks for the question. What I’ve almost trained myself to do and my team is to not pay too much attention to an individual quarter and the momentum that we might see. I can do the math the same as you by looking at all the other players and what they present in a quarter. But there are just so many other variables associated with why somebody’s quarter might look the way it does that I try not to get too caught up in something that looks negative in the quarter or something that looks positive in a quarter. So I’m not really reading much into it to be honest. I truly do believe that the market growth is stable. It was a pretty strong quarter for all of us. If that happens again in the fourth quarter and the first quarter and the second quarter, then we have a trend. But otherwise I’ve seen these up quarters and then down quarters and people get all worked up about them. But I just don’t want to burn the time or the effort associated with that because until you get a few of them together, it doesn’t really mean anything to me anyway.
Coleman Lannum:
Thanks for that, Bob. Next question please?
Operator:
Our next question comes from David Lewis with Morgan Stanley.
David Lewis:
Good morning. Just had a quick follow up for Suke and then one for Bryan, I’ll ask them both together. Suke, one thing that was absent for your 2020 earnings comment was just SG&A. This is the first time in almost two years that SG&A is down year-over-year. It’s obviously a glimpse of what higher revenue can do. Any reason that would reverse – that trend would reverse in 2020? And then, Bryan, if I take kind of stock out of your tenure at the business, your commentary on spine and dental from a year and a half ago to today, it’s almost sort of reversed a bit and I wonder if you could sort of juxtapose how you’re seeing the strategy now look for these two businesses? Thanks so much.
Suketu Upadhyay:
So, David, thanks for the questions. So first on SG&A, year-over-year we are higher as you mentioned. This is on a seasonally lower revenue base, so of course commissions et cetera are going to be lower. So you should expect in the third quarter a lower SG&A number. But again, we were in line or slightly ahead on an absolute dollars basis versus the prior year. We expect that to ramp up into the fourth quarter, one, because of higher revenues again from seasonality but also we’re investing I would say in a much bigger way against some of this growth drivers that Bryan talked about both in knee as well as beyond knee in some of the ecosystem that surrounds that key implant, but also within our S.E.T. business. So again, we expect that overall SG&A profile to accelerate as we move into the fourth quarter. And then we’re not giving specific guidance into 2020. We do expect parts of the business there will be increases in spend, but we’re also looking for resource allocation shifts. So we may chose to de-prioritize other parts of the business so that we can invest in higher growth, higher margin opportunities. We’re going to constantly look for G&A efficiencies to help fund that increased investment. So again, I’m not going to give too much guidance on 2020 and what the SG&A profile would look like, but the one thing I can say with confidence is we’re going to invest in a bigger way against those growth drivers to accelerate that top line.
Bryan Hanson:
All right. And on the spine and dental business, what I would say is that they really did kind of start in the same place from our perspective. Both were struggling negative growth and both had new leadership and they were focusing on putting a game plan in place that would allow stabilization and eventually positive revenue growth. So both had the same plan. What I would tell you is that we probably, at least I did, underestimated how complicated to being able to roll the spine plan out would be, particularly when you’re talking about channel dyssynergies that occur when you make significant changes. So if I just take spine first and foremost, I would say that’s really been the thing that has retarded our ability to get back to flat growth and then to market growth. I feel at least good that we improved from Q2 when we look at Q3 and we continue to perform below market though, and certainly I believe not at our best. We’re working through the channel consolidation that we talked about and finished towards the end of this year, but we still have work to do there. We just need to make sure that channel continues to gel. I know we’re going to launch our new products. We haven’t had a lot of new product launches in this space in a while and that is something that needs to come, and quite frankly we delayed some of that from a ROSA perspective because we wanted to double down in ROSA Knee. So we fully expect now with robotics like ROSA coming in, with Walter coming in, with the TrellOss titanium interbody that we just launched that’s a limited launch, but that was a gap in our portfolio, with the Tether technology that we just go approval on, these should be the things that allow this organization to begin to stabilize as we move into 2020 hopefully get back to market growth. That would be the way that I would look at spine. If I think about dental, the less complicated space than spine, you have less risk of dyssynergy. There’s always risk, so I don’t want to diminish what this team has had to deal with, but the fact is it’s just less complicated, less dyssynergy risk in this business and the team’s done a nice job and they really have focused with the limited assets they have in the right areas. They’ve driven a culture of accountability and they’ve shown that they can perform. Now at the end of the day, I still look at that business and say we have a ways to go, we’re still below market. So I’d like to see them show durability and positive growth, that’s the first step. And then the second step is over time get to market growth and show durability in that. So that’s really the big difference between the two and gives you a bit of backdrop in each of the businesses in the way I’m thinking about.
Coleman Lannum:
Thanks for that, David. Next question please?
Operator:
Next question comes from Robbie Marcus with JPMorgan.
Robbie Marcus:
Thanks for taking the question and congrats on the nice quarter. Bryan, you’ve done a great job stabilizing the business. Next step is to get back to market growth. What are the steps that you still need to complete before we can start to see the margin expansion down the P&L? Is that – you made it pretty clear it’s not next year. Is that something we could see in '21 and what the drivers to really get there?
Bryan Hanson:
Yes. What I would tell you is the most important driver to being able to drive margin expansion is top line growth. You haven’t heard it being coupled the way we talk about it on this call, but top line growth is the gift that keeps giving when you talk about leveraging the P&L. So that will come. Obviously, we already feel like we’re in that 2% to 3%. That’s a big difference from where we were before and that does help drive margin. The other pieces are just going to be the good old fashion cost down. We haven’t had a lot of focus in our manufacturing organization to take cost down. We’ve only had the headwinds. We’ve had no push against those headwinds and that’s something that has changed. It takes a while for that work to capitalize into our gross margin number, but that will be coming. And then we’re also going to be looking at our organization to say, are we spending in the right areas? The fact is, we spend a lot of money and we haven’t been as judicious or disciplined in the way we spend that money. So you’re going to see certain categories that are very interesting to us that have high weighted average market growth opportunities where we think we have the right to win, we’re going to be doubling down in spend and we’re going to be taking from areas that don’t have those same opportunities, so kind of a mix shift that occurs there as well. So it isn’t just increasing spend to get growth, it’s being smarter about how we spend the money we already have. So all those things I think will contribute. And the fact is, one of the strategic pillars that we have as an organization is to be a top quartile performer in total shareholder return. That does not happen without margin expansion. So just know as we get passed 2020, we will have our eye very focused on margin expansion because it is a very important part of the equation to deliver one of our strategic commitments.
Coleman Lannum:
Thanks for that, Robbie. Next question please?
Operator:
Our next question comes from Larry Biegelsen with Wells Fargo.
Shagun Singh:
Thank you so much. This is Shagun in for Larry. Bryan, I wanted to talk about supply levels. The current supply levels are factored into your 2019 guidance, but you haven’t negated that you will be supply constrained on ROSA for some time. So can you give us an update on supply, which products continue to be impacted, what steps are you taking to expand the supply for ROSA TKA in 2020? And then will there be sufficient supply for ROSA ONE Spine beginning next year, especially as you try to meet larger orders for ROSA TKA? Thank you so much.
Bryan Hanson:
Yes, I appreciate the question. So what I would just tell you is that I don’t view supply in any way, shape or form as a barrier for us to deliver the commitments that we have put out there. We’re going to over achieve those commitments, by the way, if things go the right way. I would just tell you that with ROSA in particular, I don’t see any supply constraints at this point. We put a governor on how we’re approaching the market because we want to make sure that we do this smart, that we learn what the flaws may be in the way we educate when we bring ROSA to the marketplace. So we put a governor on how we’re going to market, but it’s not because of capacity constraints. So I just want to make sure that I’m clear on that. As a matter of fact, I’d go further to say I hope we have a capacity problem in 2020 because that would mean that we’re doing very, very well in the marketplace. So I don’t see capacity from a manufacturing perspective and/or the other variables associated with commercial infrastructure, education, service levels, I don’t see those things being an issue for us with ROSA and I don’t see them being a major barrier for us in any product category.
Coleman Lannum:
And, Shagun, I want to make sure we’re very clear. Consistent with what Bryan just said, we’ve never said that capacity was an issue for ROSA. So that may be what some people have speculated out there, but this is not a change from anything we’ve said all along. We’ve never said that that’s going to be an issue.
Bryan Hanson:
Again, I hope it’s an issue in 2020. That will be very good for all of us.
Shagun Singh:
Thank you.
Coleman Lannum:
Next question please?
Operator:
Our next question comes from Richard Newitter with SVB Leerink.
Richard Newitter:
Hi. Thanks for taking the questions. Just going back to the margin expansion commentary for 2020, I appreciate and totally understand why top line is paramount and why you’d invest. I guess I just want to make sure I’m understanding. If you see opportunity to accelerate or the investment to ultimately drive higher top line, is that a comment to suggest that that would potentially lead to a situation where there’s no margin expansion or just the limited margin expansion guidance that you have out there for 2020 is inclusive of the potential for kind of accelerated investment? Thanks.
Bryan Hanson:
I’d just comment and Suke, if you want to provide any additional color. I think the original way you’re looking at it is correct. We’re looking at marginal margin expansion in 2020. But if we see an opportunity to be able to invest and drive revenue growth rate up in the short term, we’re going to take advantage of that. That is the thing you should want, that is the thing that we want, because that’s the only sustainable way to drive margin over time. We can easily cut cost and that can give you a lot of margin expansion in 2020, but that would the absolute wrong thing to do because the top line growth and accelerating that top line growth is the way to do it sustainably. So if we have opportunity in 2020 to be very clear to be able to invest and drive short-term growth, we will do that and forego margin expansion in 2020 with the idea that that gives us the runway to a do it sustainably and really being to show that traction in 2021.
Coleman Lannum:
And, Rich, let me clarify again. Again, that’s consistent with what we’ve said along. We’ve talked about potentially getting margin expansion in 2020. We’ve also every single time given the caveat that even if we do that, it would be relatively small given the pressures that we’ve talked about on gross margin. So I don’t think that should come as a surprise to anyone. Next question please?
Operator:
Our next question comes from Matt Taylor with UBS.
Young Li:
Hi, guys. This is Young Li for Matt. Thanks for taking our question. I appreciate the comment earlier on the 2,000 ROSA cases. Can you maybe just talk broadly about the utilization rate within ROSA accounts? Are you seeing deep penetration within the accounts, signs of pull through, any type of color would be really helpful?
Bryan Hanson:
Yes. So what I would just say is just do a correction here. It’s been well more than 1,000 cases that we’ve had on the real world with ROSA so far out of the gate, and again feedback has been very strong. What I would say is we’re learning. Utilization rates were all over the place. It depends on how long the system has been in, how focused the surgeon is that we’re bringing it in is on using it in his cases or her cases. So I’d just say it’s too early to say what the utilization rate we think is actually going to be. But we’ve seen so far is pretty consistent with what our competitor has talked about. That just gives you some feel for it. What I would say as we continue to move forward, we’ll get a better understanding of that utilization. I would expect that over time as people get used to the system that we would actually see more utilization than what’s out there today, because one of the primary things that frustrate surgeons with robotics is typically robotics slows them down in the surgical procedure and as a result of that they don’t get the same throughput, which means they don’t use all the time because they want to make sure that they have patients moving through the operating room. Just like a factory, you’ve got the fixed expenses, you want to move the patient through because that’s how the surgeons make money and the hospital makes money. Our robotics system actually makes that easier because it doesn’t change as much as the workflow and allows the surgeon to conduct a product basically in the same time they had before the robotics system, but just more accuracy now. So again, too early to tell but I would expect our utilization to look pretty good over time.
Coleman Lannum:
Thanks for that, Young. Next question?
Operator:
We’ll take our next question from Rick Wise with Stifel.
Rick Wise:
Good morning, Bryan. Maybe with a bunch of the specific questions asked, I’d focus on the turnaround itself. You’re driving obviously a significant turnaround at Zimmer with significant cultural and operational change. And at a high level, I’m sort of curious, where do you think we are in that process? It seems like in multiple fronts you’re well ahead; spine more work to do, but maybe from here you could highlight some of the specific operational work to be done in terms of – and I’m just throwing out some ideas, answer it as you will, the manufacturing footprint, the ability, the possibility of working capital reduction, just the whole operational excellence process that I assume over time will also lead to enhanced cash flow, more available capital elsewhere. Just that whole theme as you contemplate what you’re trying to make happen in Zimmer? Thanks so much.
Bryan Hanson:
Absolutely and I appreciate the question. So what I would tell you is that we still have to make sure that a lot of the things that we’ve changed actually gel. The fact is when you’ve had an organization that has been struggling for as long as Zimmer Biomet has, it takes a lot of change. The only way you’re going to actually fix it, moving in the right direction and truly shape it for success to make significant change, and we have. And so just to give you a couple of examples of those things that we still need to get some time, but we’re moving in the right direction. We’ve got to give it some time. It’d be the number of new leaders that I have in the business. You think about the number of new leaders that I’ve brought in, 70% plus of my team is new, that same thing is happening below them. So we need to make sure that those individuals settle in. They show durability in driving this kind of increased effectiveness and I’m just going to call this maniacal focus on delivering what we say we’re going to deliver. That’s a cultural shift for the organization that we’ll take. So I just got to see that happen. A lot of these people have been here less than a year, so I need to make sure that they’re getting traction. We’ve also changed the structure of every one of our regions in every one of our businesses, and again less than a year ago. So we need to make sure that that gels and that we continue to drive success with it. And we’ve got a bunch of new products that we’ve launched. We had to get the new product engine going. That was a big part of the variables in this equation. It’s happening. We’re still in the early phases of those launches. It’s going well, but they need to go through that full launch phase and they need to continue to perform the way they are performing today. Those are a lot of things. Another big one is I feel really good about where we are with quality remediation in the North Campus. But the fact is the only square part that counts is when the FDA comes back in and they tell us that they love what we’ve done. Now we think we’re in a position to be able to make that happen, but that’s still something that’s got to gel. As we continue to progress through those in parallel, we’re now working on things that you’re talking about. We’re moving away from this idea of supply stability and moving to efficiency in supply. And when I look at the network of manufacturing facilities we have, we’ve got to attack that. We got to do it in a smart and strategic way to understand what the footprint should look like and over time we need to reduce the footprint to make sure that we have the right organizational structure and footprint to be able to support what we need. I also look at this business, this is what’s nice as being an outsider to orthopedics coming in and I will get the inefficiency associated with the amount of inventory that we have and the amount of inventory we write off every year in E&O, hundreds of millions of dollars every year that impacts my P&L. We are going to attack that. We’re putting teams in place now to understand why is the DOH the way it is, how do we start to bring that DOH down through systems and different business models and ultimately as a result of that start to get the benefit of reducing the E&O, because that will help our P&L. So know for sure that we’re already beginning to pay attention to those facets of the business and we see opportunity. There’s no question. It’s going to take time to get after it, because we still have to have these other parts of the business gel that we’ve been moving forward on, but we’re already starting action in those areas.
Suketu Upadhyay:
Rick, this is Suke. Just to build on what Bryan said, we sort of summarize all that to the entire organization through four key pillars which is ultimately aimed at being a top quartile performer. And so we look at that and we speak to the organization about revenue acceleration, where do we need to invest, what markets, what categories that have high market growth rates, where the products that are going to take us above weighted average market growth. Then we look at margin expansion. Bryan talked about how do we declutter the supply chain, through SKU rationalization, through better optimization of our footprint, through other efficiency and value engineering type ideas, but also through SG&A and taking our very fragmented sort of operating base and start to gain some more efficiencies out of that. The third level we then talk about is free cash flow yield. So how do we improve the cash flow generation on our earnings? And Bryan talked about one of the biggest opportunities that we’re attacking is around working capital and specifically on inventory and just how much we have out there and the opportunities to even get to a peer level of working capital would free up and liberate a lot of additional free cash flow that would give us optionality in filling portfolio gaps. And then the last metric that we look at and that the organization basis decisions on is ROIC. And so it’s not only the elements that Bryan talked about but it’s summarized very succinctly and lived by, by the organizational process for key metrics.
Coleman Lannum:
Operator, we got time for one last question, then we need to wrap please.
Operator:
Our final question comes from Mike Matson with Needham & Company.
Mike Matson:
Hi. Good morning. Thanks for fitting me in. So, Bryan, I think you mentioned that you think that Zimmer can grow over the 2% to 3% WAMGR without doing M&A. So just curious what would drive that? Is that primarily robotics? Is it share gains? Is it something else? Thanks.
Bryan Hanson:
Yes, it’s a great question. So first and foremost, we have to see and I believe we will because of the structure we’re putting into place and the morale change, but we have to see the Americas improve. And just general, if I think about geographically speaking, the Americas has to improve. It’s 62% of our business. It has to move in the right direction. Underneath that, the things that we’re going to be highly focused on is getting our knee franchise above market. And I really do believe it’s going to take time for all the reasons that I mentioned before, but we can get durably the knee market – our knee business to grow above market. That has to happen. It’s got to happen through new product launches, particularly around ROSA, but also the ecosystem that we’re building in and around it and then just traction and focusing on the fastest growth submarkets. You’ve got Cementless, you’ve got Partial and you’ve got robotics; very attractive submarkets of knee where we have very good launches and morale boost inside of those. Another big one is S.E.T. with specific focus in extremities. The fact is we have to get that durably in mid-single digits. That’s the market growth. We have to be able to be there consistently. We haven’t proven that in the past. We’re moving in the right direction. We have new products. We have the specialization of the sales organization. We’re changing the comp structure. We’re making sure that we have better operating mechanisms. But those things must happen. If I can just get knee above market, we can get S.E.T. at market. I can keep hip right around that market growth and I can get some slightly improvement in spine and dental staying where it is, that can get us above that 2% to 3% growth. I don’t want to offer this up today. I really want people thinking as you model 2020, 2% to 3% is the right place to be. But I absolutely see a pathway to get above 2% to 3%. I think just a backdoor here. If you go back – I don’t think I mentioned this, but you go back to 2015, we’ve only had three quarters as a company, as Zimmer Biomet, including this one where we were above 2% growth. That’s going all the way back to 2015. So let us just get used to being able to do the 2% to 3% durably. And once we do that, we’re not going to be happy with that. Obviously, we’re going to move north of it. That will come through things that I just mentioned. And very soon with the right targets, with the right returns, we’ll add to that our M&A to be able to boost traction in that area.
Coleman Lannum:
Thanks for that, Mike. And with that, we’re going to conclude the call. Really appreciate everyone joining us. Also really appreciate that everyone, with the exception of one person, complied with the one question-only rule. I’ll talk to that person offline. But thanks to everyone because of that we were able to get a lot of questions in. As a reminder, a replay of the call will be available later today for a review on our Web site at zimmerbiomet.com. And we’ll able to take your questions as needed. Have a great day and great week. Bye-bye.
Operator:
Thank you again for participating in today’s conference call. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet Second Quarter 2019 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today, July 26, 2019. Following today's presentation, there will be a question-and-answer session. At this time, all participants are in a listen-only mode. [Operator Instructions] I would now like to turn the conference over to Cole Lannum, Senior Vice President, Investor Relations and IRO. Please go ahead, sir.
Coleman Lannum:
Thank you, operator, and good morning. Welcome to Zimmer Biomet’s second quarter earnings conference call. I'm joined by Bryan Hanson, Suketu Upadhyay, and Dan Florin. Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please note that we assume no obligation to update these forward-looking statements, even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties in addition to the inherent limitations of such forward-looking statements. Also, the discussions on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within the earnings release found on our website at zimmerbiomet.com. With that, I'll now turn over the call to Bryan. Bryan?
Bryan Hanson:
Thanks, Cole. Before we actually get into the quarter and any news of the back half of the year or beyond when don’t we just go ahead and address the elephant in the room. I'm sure we have had a lot of people talking about the CFO transition. People have been writing quite a bit about it, even some people thought that may be the CFO transition might signal that we didn't have confidence in our guidance. This morning has already proven that's not to be the case. This truthfully is just Dan's intent to spend more time with his family and who are we to get in the way of that aspiration, really that truly is what it is. Dan was kind enough to give us enough notice, me specifically, to be able to really set this up in an orderly way. Without that time you can't have a proper transition. You can't plan to organize this thing in a way that is not disruptive, and Dan gave us that opportunity. That's really what this is all about. You know, the good news is, because we have done this an orderly fashion, I get the great opportunity to have an earnings call with two CFOs by my side and my IR guy. So I'm pretty much don't even need to be here today. So I'm looking forward to this call. I think I can actually relax on this one. Suketu, I just want to say to you, welcome to the team, brand-new on the team. This is your first call obviously as CFO of Zimmer Biomet. Important day for us and important day for you. I can tell you that Suketu I had a feeling he would during the interview process, but the guy's jumped right in. It's just been a handful of weeks, but he is already getting to know the finance team and the broader leadership team. He is digging into the short-term financials to make sure that he feels comfortable with where we are, so a lot has been done in a very short period of time. I'm pretty confident the guy doesn’t sleep. I know that he is going to be a great cultural fit as a result of that, fitting in quite well with leadership team. I know that through the interview process and it's playing out already. Again, early days, but strong so far, and I think everybody knows that this guy brings a wealth of experience to our organization. He has been a finance leader and just general leader for many years and clearly has a lot of experience in the healthcare space, which is going to be extremely applicable Zimmer Biomet. Given that you've had a few weeks, why don’t we give you an opportunity maybe to just say a few words on your first impressions and that will start the business.
Suketu Upadhyay:
Thank you, Bryan. I'd like to thank you and the rest of the team for all the introductions over the last couple of weeks and all the support in bringing me up to speed. My early observations are all very positive and if anything I think surprises to the upside. One, I think we've got a leadership team and more broadly than that an organization that has an aligned view of the strategies and the priorities of the company. Two, I've seen an organization that has a bias for action and that's really around patient centricity and value creation. And I think third, what I've seen is we clearly have a very strong corporate conscious to do things the right way operationally, from a compliance standpoint, and with the patient always in the center of deal. So far the transition with Dan is going really well. I want to thank him for his counsel and his support. He has built some very high quality teams within the company and beyond that he is leaving a very positive and enduring legacy in many areas and many aspects of the company. I look forward to reconnecting with many of you and for those of you that I have not had the chance to work with me yet I hope to do that in the very near future. And all I can say is, I really look forward to driving value and being part of the team.
Bryan Hanson:
Excellent, first words spoken as CFO is a [indiscernible] to the investment community. Welcome again to the team and we're looking forward to some big things from here. And it would remiss if I didn’t say a few words about my man Dan sitting across me right now. I'd just say first of all this guys, I think everybody knows is a phenomenal leader. He has done so much for this organization over the years and truthfully from the very beginning, even in the interview process quite frankly, this guy has been there for me. Truly has been what I would just define is my right hand from the very beginning. I think it's important not just to look at the capability as the finance leader and the leadership that he has provided ZB, but also the fact that this guy has high integrity. He is an authentic leader and he proves that to me every day. I would say Dan, we've made some pretty difficult decisions over the past year and a half, anywhere from talent decisions to structure, to culture, I mean you name it across the board some of these quite frankly were not easy decisions, not for me and certainly not for you. I know that they were probably more personal for you than they were for me because you've been with the business longer, but what I would say is you never let that get in the way. This guy through and through has made the right decisions for the right reasons for the organization and I am 100% confident we would not be where we are today without your leadership. So I want to thank you again on behalf of all of ZB for your leadership over the years as CFO, as interim CEO and I want to personally thank you for the counsel that you provided me over the last year and a half. This is officially, I'll put in here quotes "your last call as CFO of Zimmer Biomet." I'll be a little emotional for you, it is for me, and I want to give you an opportunity to say a couple of words.
Daniel Florin:
Thank you, Bryan and really thank you for your kind remarks, very humbling. And I really want to thank you for your friendship and your incredible leadership of this great company. It is palpable [ph] the difference that you have made and your leadership has made. And it's evident in the turnaround progress that we're making. So thank you for all that you have done for me and for the broader ZB community. It's been a real privilege working side-by-side with you over the past year and a half and I look forward to helping you and the management team in the coming months on some critical projects. So thank you from the bottom of my heart, thank you. I appreciate it man.
Bryan Hanson:
And the good news is, just to make sure we calm everybody down, although Dan does want to spend time with his family and again I'm very supportive of that, he is being gracious enough to give us time to make sure this transition goes well, the pass off responsibilities in an orderly way to Suketu and to stay on and as you just said, work on some key projects that we have. So anyway, again Dan, thanks so much, I appreciate it. Why don’t we go ahead and jump into the quarter now? So looking then at Q2, the team delivered another quarter of improving financial results with revenue growth driven by better performance in all geographic regions, as well as across most of our businesses. This morning we updated our guidance to reflect our increasing confidence in the ZB turnaround and our commitment to investing for growth. Our people are focused and engaged at a level that I personally haven't seen since I joined the company. We're seeing real progress in the business and while we still have work ahead of us, I'm truly excited by our momentum. In terms of supply, we continue to drive efficiency throughout our supply chain to ensure that we meet increased demand for our products and drive confidence in our sales team. Our quality remediation efforts at our Warsaw North Campus remained on track and we continue to keep the FDA updated on our progress. We are highly confident in our progress and path to full remediation. Additionally, we have now rolled out our culture program called "Quality Begins With Me" at all of our sites and we are building a sustainable quality culture as a result. We're excited by several key new product introductions this year and we are seeing the benefits of our engineering teams turning from quality remediation back to innovation to support what is becoming a robust pipeline in 2020 and beyond. Inside of these new product introductions, we are executing against our strategy to deliver an ecosystem of customer centric solutions, including our ROSA robotics platform and mymobility our digital health platform developed in partnership with Apple and our flagship Persona Partial and Cementless, as well as Knee System offering a more personalized solution for our patients. We've also increased accountability and strengthened ZB spirit across the organization as a result of our new structure, new leadership team, and through our relentless focus on culture and connection to our mission. This is evidenced by a recent team member survey were more than 80% of respondents feel confident or very confident in Zimmer Biomet's future, strategy and leadership and feel the company is much better positioned today than a year ago. Moving to our second quarter results, we benefited from continued strength in the Asia-Pacific region, another solid quarter in EMEA and improved performance in Dental, S.E.T., in the Americas particularly in the knee business. We are excited to report the best growth rate we've had in knees in the last three years. This is the result of continued strength in Asia-Pacific and improving growth in EMEA and most notably in the Americas. We are beginning to see the benefits of increasing confidence from the sales organization, better sales execution driven by more disciplined and rigorous operating mechanisms and our new product launches, particularly with critically with persona partial and Cementless, as well as ROSA Knee. Specifically related to ROSA Knee even though we are in limited launch, system revenue did provide a benefit in the quarter, which we are confident will be further enhanced as we enter Q3 and beyond. Importantly, even when excluding ROSA sales in the quarter, our global knee business delivered positive growth, accelerated growth sequentially, and further narrowed our gap to market and it did all of this despite a tough comp in the quarter. Speaking of new product launches, all the launches are delivering as planned or better. Since everyone is highly interested in ROSA, I'd like to take a minute to tell you how the limited launch is progressing. The ROSA knee system is receiving very high marks out of the gate and feedback from surgeons is very positive. While the overall number of placements in the second quarter remained relatively small, it's clear we have a solution that is attractive to our surgeon partners as evidenced by the surgeon feedback we received from the hundreds of procedures that we've performed since launch. Most importantly though, demand is strong and it is growing daily. As expected, the internal and external energy around robotics is clear and as a result we intend to increase our investment in robotics as it relates to both research and development and commercial infrastructure. This increased investment will begin in the second half of the year which Dan will discuss later in the call. Our S.E.T. business showed solid growth in the quarter as a result of supply stability which continues to grow sales force confidence, increased traction in the specialized sales channel that we've invested in and new product launches across the business. Moving into the back half of 2019 we will accelerate the expansion of the investment in our specialized sales channel in order to further increase our focus on these high-growth S.E.T. markets. We also saw continued improvement from our dental business which has been gaining traction over the last few quarters. In fact, this is the best quarter for Dental since the Zimmer Biomet merger four years ago. Though there is still much work to accomplish, the focus on strategy, investing resources in priority areas, operational improvements and enhanced culture, have brought new energy to this business. While we saw broad improvements across our organization, we continue to see pressure in Bone Cement in line with our expectations, albeit at the lower end of the 10 million to 15 million per quarter we referenced in the past. We also experienced growth deceleration in our Spine & CMF business in the quarter. Although we're not happy with our growth rate here, much of the sequential deceleration from Q1 is due to difficult comps. As we begin to retire some of the comp challenges, work through the final steps of our channel consolidation in spine, and fully launch a number of new products including ROSA spine and Walter, which will occur in the first half of 2020, we certainly expect to see improvement across this business. So as you can see, we have a lot going on and we are making strong and steady progress. We have built a solid foundation over the last 18 months and have dramatically reduced the risk in the business. As a result, we have updated our 2019 full-year financial guidance to reflect our believe that we will achieve our weighted average market growth rate six months ahead of schedule beginning in the third quarter of this year. We intend to build on the momentum and execute against our plan to accelerate revenue growth, drive margin expansion and increase free cash flow, all with an eye toward significantly increasing shareholder value. And with that, I'll turn the call over to Dan to go through the numbers.
Daniel Florin:
Thank you, Bryan. I will provide highlights on our second quarter financial results and go into a bit more detail on the updated 2019 guidance provided in this morning's press release. Net sales totaled $2 billion in the quarter, a decrease of 0.9% from the prior year period with an increase of 1.2% on a constant currency basis. As we noted previously, while there is no impact on our growth rate from billing day differences for the full-year, there was about a day of headwind in the first half which was spread fairly evenly across the quarters. During the second quarter, we have solid results across all geographic regions. Our Asia-Pacific team delivered strong performance with 4.7% sales growth, while our Europe, Middle East, and Africa team increased sales 1.9%. Americans increased 0.1% reflecting improved performance across the majority of our product categories. Importantly, despite tougher comps, this represents sequential improvement of 100 basis points compared to our first quarter growth rate in the Americas region. As Bryan noted, we saw improved performance in several product categories during the quarter. Our Knee franchise grew 2.5% on a constant currency basis with solid performance across all geographic regions. In addition, S.E.T. and Dental businesses on the same basis grew 4.3% and 1.7% respectively. Moving to the income statement, we reported a GAAP diluted earnings per share for the quarter of $0.65. After adjusting for special items, our non-GAAP adjusted diluted earnings per share were $1.93. Reconciliation of reported earnings per share to adjusted earnings per share is included in this morning's press release. Included within special items, we recorded a $70 million one-time non-cash charge in the quarter related to the termination of certain in process R&D projects. This reflects the progress we are making to prioritize our internal R&D portfolio and focus our engineering resources on the opportunities that are most closely linked to our mission and have the greatest market potential with the highest financial return. Adjusted operating margin was 27.4% for the quarter and in line with our expectations. The adjusted effective tax rate for the quarter was 17.5% as expected. Operating cash flow for the quarter amounted to $301 million and our free cash flow was $161 million. During the quarter we paid $49 million in dividends and paid down $115 million of debt. Moving to our updated 2019 full-year guidance, starting with revenue, we now expect 2019 reported growth to be in a range of flat to positive 0.5%. Included in our reported growth range is a negative impact of foreign exchange which we now expect will reduce reported sales between 125 and 175 basis points at current rates. The impact of FX on sales should be much smaller in the second half compared to the first half of 2019. We expect to deliver growth in line with our WAMGR on a constant currency basis during the second half of this year which is six months ahead of schedule and we also expect to see sequential improvement in every product category versus the first half of 2019. To help you with your models, there are two factors that will impact the quarterly revenue phasing for the second half of 2019. First, the majority of the headwind from billing day differences in the first half which was about a day will be offset in the third quarter of 2019. Again, there is no impact from billing day differences on the full-year. Secondly, remember that in the fourth quarter of 2018 we received a one-time revenue benefit from a rebate adjustment in our EMEA region which creates a tougher comp for overall revenue growth in the fourth quarter of this year. Turning to EPS we are narrowing our full-year 2019 adjusted diluted earnings per share expectations to a new range of between $7.75 and $7.90 per share. Included in this updated range we now expect our adjusted tax rate to be between 16.5% and 17.5% as we continue to execute on certain tax planning activities. The upside from tax will allow us to increase our investments in the areas that Bryan highlighted during his prepared remarks. Specifically, enhance sales specialization in our S.E.T. business, expanded and accelerated commercial infrastructure to support the launch of ROSA Knee, as well as additional investments in R&D. As you look to update the components of operating margin for the second half, while operating expenses will increase for these investments, you should expect our gross margin rate in the second half to step up in over the first half. This improvement in gross margin was assumed into our original guidance and is driven primarily by anticipated refunds of prior period medical device excise taxes which will impact the third quarter. Therefore we are updating our operating margin for the full year 2019 to be between 27% and 27.5%. With that, I'll turn the call back to Bryan. Bryan?
Bryan Hanson:
All right, thanks Dan. And before we move into Q&A, I want to say again that I'm pleased with the significant progress the team has been making. Compared to early last year when we began this journey, Zimmer Biomet truly feels like a different company. The energy inside of our organization is real. I'm excited that our second quarter results, as well as our updated 2019 guidance demonstrates the progress of our turnaround and our enthusiasm for the future. And with that, I'm going to turn it back to Cole to get into the questions.
Coleman Lannum:
Thanks Bryan. Before we start the Q&A session I want to remind you again to please limit yourself to a single question with a brief followup if and only if needed. Feel free to put yourself back in queue afterwards. I promise we'll get through as many questions as possible that way. With that operator, may be please have the first question?
Operator:
Thank you, sir. [Operator Instructions] We'll take our first question from Raj Denhoy with Jefferies.
Raj Denhoy:
Great, thank you and good morning and Dan I just want to add my congratulations on the next phase here. You know, I want to focus on the U.S. Knee growth if I could. You know, obviously it was the best growth we've seen in a couple of years here. You mentioned a couple of drivers there, ROSA, some mixed benefit from new products, but what I wanted to get at was underlying volumes and where you think you are from a share perspective and have you sort of stemmed the share losses you've seen or where is that tracking in your mind?
Daniel Florin:
Yes, Raj. So what I would say is we definitely closed the gap to market in the quarter. You know the momentum was real pretty much across the board and we're excited about closing that gap and at the same time we still feel like we've got real headroom here. You know, 2.5% may be the best we've had in a few years, but we really do believe there is even more potential in the knee arena. So we had a number of things go right. I mean I just kind of walked through them. You know, we don’t want to discount the value of increasing confidence and morale in the commercial organization. When I think about supply, if you look at our current position in supply, it's significantly better than when were at our worst. I would say we had somewhere in the neighborhood of four days of backorder at the worst of this supply issue, we're down to a day. And as I said in the past, the organization would have a delayed response to getting back to steady-state supply would take a while for the organization to feel confident after some of the posttraumatic stress disorder they had at the beginning, but I do believe we're there. The organization confidence level is high and their posture around offenses is good as I've seen. So that was a major contributor in the quarter and that's the gift that keeps giving, so that's an important one. Also we're seeing increased discipline in the way that we manage the commercial focus of our organization, particularly in the Americas. We're really making sure that we have an increased operating mechanism discipline focusing the organization around segmentation better than we have in the past, really being data-driven as a result of that and driving increased accountability. That also played a role and that is also a gift that will keep giving. And there's the new products as you mentioned, I mean obviously we've got ROSA Knee coming out of the gate pretty strong, still limited launch, but feeling really good about it. Persona family of launches is doing quite well also. So it's a combination of those things that that are really driving the momentum and that is allowing us as a result to close the gap to market, but we may be happy about that, but we're not going to be satisfied until we're above market.
Coleman Lannum:
Thanks for that Raj. Next question please?
Operator:
Our next question comes from Joanne Wuensch with BMO Capital Markets.
Joanne Wuensch:
Good morning and thank you for taking the question. Your commentary on the second half of the year would imply increased confidence. What is giving you that increased confidence and how do we think about that then rolling into 2020?
Bryan Hanson:
Well, it’s a number of things actually that I just talked about. I mean, if I'm going to break it down into its simplest form, the thing that gives me most confidence and the things we need to see happen in the back half and beyond, I really - I’ll make very simple, two things, we need to see the knee franchise continue to improve, you know that is the number one most important thing. But we also need to make sure that if that occurs we don't let things slip from our focus perspective and S.E.T. So if we get the knee franchise continuing in the progress that we've got and we make sure S.E.T. continues with the traction it’s getting, those are the things that need to happen to have the confidence we do in the back half and into 2020. Couple of the sub-elements of that that make me confident that we're positioned well, for both of these, whether it be knee or S.E.T., one of the primary things is this confidence that I just talked about. The confidence level is high in the organization, supply is where it needs to be, people are more confidence that if they need a product they are going to get it. And again, as I said before, that hasn’t always been the case in this organization and it means a lot. The second one is that, discipline. You know that operating mechanism discipline that we have to drive accountability. You say something, you will do something in this organization, you will accomplish it and that operating mechanism also ensures that we have the discipline to stay focused in S.E.T. even when large joints start to do well. And the final thing which is kind of obvious for both of these is new products. We have new products across both platforms and we are going to take advantage of those and then the thing in S.E.T. that is different is we are increasing or doubling down in our specialization in sales organization. And you know, on top of that you've got to be more than just specialized. You also have to make sure that you have the compensation structure to ensure that the focus remains in S.E.T. even when large joints takes off. And so, those are the things that need to happen in the back half. We have confidence they are going to happen and those will be the areas that we focus most heavily on, both in the back half of 2019 and into 2020.
Coleman Lannum:
Thanks for that Joanne. Operator, next question please?
Operator:
We'll take out next question from Matthew O'Brien with Piper Jaffray.
Matthew O'Brien:
Good morning, thanks for taking the question. I’m sure you’ll get a bunch of ROSA questions here in a minute, but I was curious about the commentary on investments in the back half. I think beyond which you had been anticipating, can you, without giving away too much to your competitors, talk a little bit about where that may be allocated between maybe more sales reps, more marketing and R&D, and are those incremental investments designed to get you above the WAMGR in 2020 and beyond? Thank you.
Bryan Hanson:
Yes, you know, it's interesting because when we think about increasing our weighted average market growth, you know, we've talked a lot in the past and people always asked questions about when are you going to do active portfolio management to drive your weighted average market growth up? What we’re saying is, eventually we'll get to that, but right now there are opportunities for us to do that in the businesses we are playing in by shifting resources. As an example, if you look at overall knees it's not that exciting of a growth business or growth market. But when you look at the sub-elements of certain categories like robotics, like cementless, there's clearly opportunity for outweighed growth. So we want to make sure that revising our investment to those areas, that’s number one, right? So the whole goal of this is, choose those submarkets that are most attractive, bias investments to those which would be R&D, commercial investments and others, and that’s exactly what we’re doing. The second piece of it is though, we’re actually getting better feedback even than what we expected. And as a result of that, we want to lean into the investment and make sure that we are increasing investment in research and development, to be able to fill some of the gap areas that we have in robotics, but I think more importantly to move ahead. You know, we don't want to just fill gaps that exist in robotic applications today. We want to be able to bring a more integrated ecosystem of robotics that will differentiate us beyond what other players have. And so that’s where some of that R&D money is going. In addition to that, to be able to be prepared for the demand that we’re seeing, we want to make sure that we have the right commercial infrastructure. That’s not just sales teams, that service, that’s education, that’s everything that we need to be able to rollout ROSA in an effective manner. That’s what we’re seeing, we’re seeing an opportunity to invest in a higher growth submarket, and we’re seeing an opportunity to respond to better demand than what we expected.
Coleman Lannum:
Thanks for that, Matt. Next question please?
Operator:
Our next question comes from Matt Miksic with Credit Suisse.
Matt Miksic:
Hey, good morning. Thanks for the question. I just wanted to followup on the Raj’s question on the knee business in the quarter if I could. You mentioned a lot of things went well and the numbers clearly, you know the best you've delivered in a long, long time. But just a couple of things in that list of things that went well is, maybe just clarification on closing the gap versus narrowing the gap to market, and you know where you wound up with press fit [ph] mix that was a bigger driver you talked about the past, and then just this 8% average of that you’ve been delivering in APAC growth has been very, very strong and just in the overall knee business if you could maybe elaborate on those that would be super helpful?
Bryan Hanson:
Yes, so I'd just first say on Asia-Pacific, it is a juggernaut in our business for sure and the thing is every time I get out to the Asia-Pacific region and spend time with that team, they continue to give me confidence that they can continue that type of performance. So I truly do feel that that is in fact the case. They’ll continue to drive strong performance in their business. But we’re also seeing and probably most importantly, when you look at the knee franchise the Americas pick up you know, we’re seen some good life in the Americas and that needs to continue. It needs to actually grow, but we haven't been able to say that for a very long time and that's an important part of this equation. And same with EMEA, I mean, right now we've got all of our regions improving. Asia-Pacific is staying where they have always been and I would assume that all three will continue that momentum. When I look at cementless, clearly this is a focus for our organization. Robotics and cementless, two of the most important areas of focus for us in knee, they are great because they give us an opportunity to be able to get a mixed benefit as you referenced. I’m not going to get into the specifics about the percentage that we think we’re going to get penetration of cementless or robotics, I’m not going to get into specifics relative to how much of our growth is going to be dependent upon that. But guaranteed we will be heavily focused on making sure that we get that mix benefit leveraging those technologies. And not just those, mymobility fits into that category as well. So we have cementless, we have robotics, we have mymobility. These are all technologies that are very attracted to our surgeon partners and our providers. And as a result of that, we can get an up-sell in the procedure without having to get a new customer, a new patient and truly just upgrading the procedure. So we bring real value to the patient and the surgeon and we get to get the uptick and mixed benefit for the organization. At the same time, I’m feeling more confident that those same values that we can bring to the surgeon also give us an opportunity to take competition as well right? To truly take competitive share. So I’m going to go after that mixed benefit for sure with friends and family, but I truly do think we’ve got an opportunity to leverage those same technologies to be able get competitive share as well.
Coleman Lannum:
Thanks for that Matt. Next question please?
Operator:
Our next question comes from Matt Taylor with UBS.
Matt Taylor:
Hi, thank you for taking the question. I just wanted to ask about your decision here to reinvest or double down in S.E.T. and make some investments with the savings that you got from tax. And the question I want to ask is, is this just something that we’re going to see in the second half or can you talk a little bit about how those investments will play out into 2020, and when do you start to see more of the payoff from them? Any color on those investments and what we should expect from them would be super helpful?
Bryan Hanson:
Yes, it’s - they’re really, most of the investment on the S.E.T. side will be around commercial infrastructure, specialization of the sales organization, not as much in this situation on the R&D side of the equation. We do feel like we've got a good portfolio of products being launched in the category, but we want to make sure that we have that disciplined specialization to help drive it. So that’s; where you’re going to see most of the investment. Now the good news is, that type of investment typically has a much shorter turnaround from a payback perspective. So I would say relatively quickly we could start to see the dividends associated with that investment and we’re already seeing it with the specialization that we have. The key piece to this though and I referenced it a little bit, is we need to make sure that we also have the compensation structure and the operating mechanisms in place to ensure that the 'specialized resources' don't all of a sudden do a stage left and go to large joints when that business is taking off. And I seen that, but we've put specialization in place and we find whenever large joints moves that specialization starts to move towards large joints, because that’s where the money can be made. We have to make sure that we don't just put phase 1, specialization in place, we have to put the operating mechanisms in place to hold that group accountable and we got to put the compensation scheme in place to make sure that they're dedicated to that specialization. So, net-net, when you put an organization in place the expense doesn't go away. I mean, it’s going to continue into 2020 obviously. But the dividend associated with that expense should also come pretty quickly.
Daniel Florin:
I would also add Bryan that the improvements in supply that we have had in S.E.T., you know, S.E.T. was hit pretty hard with supply as well, gives us confidence that the supply will be there. So it’s the right time to add to that specialized sales force. You combine that with the new products that are coming and it is the right time to do that.
Coleman Lannum:
Thanks for that Matt. Next question please?
Operator:
Our next question comes from Ryan Zimmerman with BTIG.
Ryan Zimmerman:
Thank you, can you hear me?
Coleman Lannum:
Yes Ryan, go right ahead, we can hear you.
Ryan Zimmerman:
Thank you. So you’ve changed over, I wanted to talk about spine for a second, you’ve changed over the sales force a little bit within spine and recognizing that you anniversary in the fourth quarter Bryan, what is your assessment of that spine sales force today and how do you see that segment performing upon the completion or the lapping of those comps? And you know if spine is going to be dilutive to your WAMGR over time and how should we think about that? Thank you.
Bryan Hanson:
Well, what I would tell you is, I feel good about the leadership team changes that we've made in spine. I feel good about the decisiveness of that newer organization relative to what we should do on channel, those are tough decisions. I think anybody who knows this space, when you're making a significant decision to consolidate channel there's always risk associated with that, but truthfully I’d rather take the risk, do the right thing for the channel and make sure that we take advantage of it in the future. So I feel good about all the decisions that have been taken. I feel good about the fact that we’ve moved through a lot of the channel consolidation. Now it’s just making sure that that channel jells and ensuring that we’ve chosen the right distributive partners to double down on and that will just take some time to determine whether that is in fact the case. The bigger things from my perspective to be able to see a change in momentum in this business is as I referenced, we really do need to get past some of the tough comps that we have. We've got to see this channel begin to jell. And I think that's going to take another couple of quarters for that to happen and we got to launch, from a full launch perspective some of the key products. You know, ROSA Spine is there, but to be honest we put that a little bit on the backburner to make sure ROSA Knee is ahead of the game. But now we've got to redouble our efforts to get ROSA Spine moving in the first part of 2020. Walter, I think is a great application that we can use to complement ROSA or by itself for spine applications which is a bionic arm that is independent of ROSA, but allows a kind of a mini robotics platform for spine procedures. And then we've got some gap filling products that we’re going to be launching as well that will come into full launch in the first part of 2022. So to me, do I feel good about the decisions and the team? I'm going to need to see the results as we get into 2020. You know, the variables are in place for a successful equation. If they can deliver on that equation and solve the equation, we should see positive momentum in 2020. I fully expect that that business can absolutely be a positive to our growth rate, but they have to prove it and until they do, it’s still a – you know we’re still testing it.
Coleman Lannum:
Thanks for that Ryan. Next question please?
Operator:
Our next question comes from Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
Good morning, thanks for taking the question. Dan, congratulations on your retirement and Suke, I look forward to working with you. So I’ll ask a ROSA question. Bryan, maybe if you could give us some color on some of the early feedback on ROSA total knee, who were the early adopters, the demand of that you're seeing, and your ability to meet that demand? Thanks for taking the question.
Bryan Hanson:
Yes, it’s, you know, I’ll tell you, part of the equation of having the confidence now to say that we’re going to be at that weighted average market growth six months early does come from the feedback that we’re receiving on ROSA. It is one variable in the equation. I don't want to put everything on ROSA, but it's a pretty big variable in the equation. And it’s early. We've had, as I said, hundreds of procedures that have been completed and the feedback that we’re getting from those procedures is very positive. So, I would just say the people that are actually using this system are feeling very good about the capability of the system and reliability of the system. That to me is one of the most important inputs that we’re going to get. Any time you launch a new product, you are going to get feedback. You are going to get positive feedback and you're going to get constructive feedback. I would just say that the positive is significantly outweighing the constructive in this situation. And any of the things that we’re seeing relative to constructive are more around training, making sure they have a more robust training platform so that people are ready to use this system. That's why you do a limited launch right? To learn these things, get the feedback, and adjust. But pretty much across the board every day that goes by the more feedback that we get the higher the confidence level is that we have the right system. So, again I feel, I feel very confident that we're heading down the right path and that the things are moving in the right direction. Ultimately, we still have to make sure that we commercialize effectively and move from this limited launch to full launch, but all our systems are positive at this point.
Unidentified Analyst:
Thank you.
Coleman Lannum:
Thank you, Larry. Next question please?
Operator:
Our next question comes from David Lewis with Morgan Stanley.
David Lewis:
Good morning. Maybe just a question for Dan. Dan, there was - two dynamics have been weighing on investors here the last couple of quarters. One is obviously growth and we clearly gained growth acceleration this morning. The second is actually earnings. So I guess, Dan, when I think about reinvestment in 2019, how does that alter the picture for '20 can you deliver leverage earnings next year or are there additional investments not captured by Street numbers needed to get to that 2% to 3% top line number next year? And congrats as well to both of you.
Daniel Florin:
Thanks David. Well first, if you just look at our performance on gross margin in the second quarter, the second quarter gross margin was in line with our expectations, a little bit better than the first quarter. I've talked about the foreign currency hedging gains that are in the P&L this year. In 2018 we had FX hedge losses. We got gains this year, so that creates a tailwind here in 2019. We're obviously, Dave we're not going to give guidance for 2020. We've talked in the past qualitatively that gross margin in 2020 will remain under pressure and when you think about what the manufacturing and quality teams have been through over the past two or three years, the focus clearly has been on quality remediation and supply recovery and you're seeing the benefits of that focus as we're describing on the top line acceleration. So the offset to that is, that same team has not been as focused on cost takeout in COGS. So the good news is, we're now pivoting towards that and going to sustain quality remediation and service of course. We've built a very strong operational excellence team in the manufacturing organization. Ken Tripp and his leadership team are doing an excellent job of implementing much more rigorous operating mechanisms through the plants. All of that says, we're starting to build up the momentum to get after cost reduction in gross margin, but that will take some time to materialize and then come through the P&L. So again gross margin, the takeaway is, it's going to remain under pressure. Now the flip side is, as that revenue accelerates, it does give us the opportunity to make the investments that we're describing, but that incremental growth, particularly in Knees is a very positive mix and we believe creates enough dry powder to help us think about 2020. And as we've said in the past, sitting here today, we remain committed to some level of operating margin expansion in 2020.
Coleman Lannum:
Thanks for that, David. Next question please?
Operator:
Our next question comes from Bob Hopkins with Bank of America.
Bob Hopkins:
Oh great, thanks and hi, good morning. I wanted to ask my question about U.S. knee growth, such a critical driver and obviously nice to see the improvement. And I realize that both capital and volumes contributed this quarter, but I'm just curious to hear whether the improvement in U.S. Knees in Q2 over Q1 was driven more by capital or by volumes? I'm just wondering, directionally, can you give us a sense as to which was the bigger contributor?
Bryan Hanson:
Well, I don't know that I'm going to get into specifics about the percentages or anything else, but as I said, ROSA is still in limited launch. So, we only placed a limited number of systems in the quarter, but it did play a part in the performance. But I think probably the most important takeaway Bob on this one is, even though it did play a part in the overall growth, even if I took it completely out, this was a really strong quarter in knees. It really was, and the fact is we accelerated versus Q1 even with the tougher comp. We definitely had positive growth and as I mentioned before we closed the gap without capital to the market growth and again this is all despite a tougher comp coming into the quarter. And I think most importantly on the ROSA side is, the fact is, our confidence in the system as I said, is growing and I fully expect because of that confidence in what we're seeing from our customers that it's going to play a bigger part, more material part in Q3 and Q4. And I think you know this, Bob because you asked the question before, the real benefit of the ROSA placements isn't necessarily the capital injection you get in that moment, it's the revenue annuity that you get as a result of the disposables, the service arrangements that we have, and also the implant pull-through. And so, as we begin to place these, we're going to be able to put more of an algorithm around net revenue annuity and build our confidence in what the future revenue growth of knee should look like. And so, that's the thing that gets me most excited about this. We can bring real value to our customers and patients and obviously increase the ability for us to get that revenue annuity as a result of placing ROSA.
Coleman Lannum:
Thanks for that Bob. Next question please?
Operator:
Our next question comes from Amit Hazan with Citigroup.
Amit Hazan:
Good morning. Thanks very much. I wanted to maybe kind of focus a little bit more on specific surgeon feedback. You talked about it in general a couple of times, but I'm curious what aspects are doctors most interested in so far on ROSA? And where are the areas of push back, if you can be honest about that from a surgeon perspective on the technology side, so far in the learning curve that would be - some color on that would be great? Thanks.
Bryan Hanson:
So what I would say, I'll start with the areas of pushback, which we have been relatively limited. They've been around the education needed to ensure that somebody understands how to get the registration correct on the patient, right? So you've got to get the patient registered to the system. So the system knows where the patient is and we need to make sure that the training allows people to do that effectively. Where we've had slip ups is where that training wasn't effective enough and as a result of that, someone didn't understand how to do the registration and because of that they had to go back to doing the procedure, the good old-fashioned non-robotic way, that's an easy fix for us truthfully. On the positive side of things, we knew out of the gate was that people would like the fact that they can use our implants. We are the preferred implant of any other company. We have the number one share position. Persona is a very attractive implant and people want to gravitate to it. So being able to use the implant, they know and love with the robotic system is very important to them and it is meaningful in the decision that they make on which robotic system, they're going to buy. The other pieces is, as we've said before, we've really wanted to in the design characteristics of the system to be able to allow people to really keep the surgical flow that they're used to. And so, as a result of the way we set the design of the system up, we were able to keep a very similar surgical flow and as a result of that in very short order, be able to do a robotic procedure in the same time that they were able to do a non-robotic procedure. That's really important for high volume surgeons. And by the way, that's exactly who we want to go after. The highest volume surgeons you could get on robotics is better for everybody. The other thing is, we have this dynamic tracking, which once you do have the patient registered with the system, if for whatever reason that patient or robotic system moves, our system can actually track the movement and keep you in line with where you need to be. Other systems can't do that. That's a really important feature. And then the final one is, a lot of the surgeons, don't want to have to do CT scans to be able to do the pre-surgical plan. It's more radiation than is needed for the patient. It's another step that isn't typically needed and it's costly for the system. We don't have to have that when we do pre-surgical planning for our robotic system. You can use regular 2D x-rays. We then use an algorithm and turn it into a 3D image and as a result of the 3D image you can do your pre-surgical planning with typical x-ray. So, those are pretty big differences that we have that the competition doesn't have. I've heard a lot of people say, and it does frustrate me that, well, it's not quite as good as the market leader, but it's a good enough system. I think it's completely the opposite. The feedback that we're getting is that it is a better system than what's out there and people are excited about that. And so, I truly do believe these variables that I just referenced do absolutely put us in a position to compete well.
Dan Florin:
Yes. There will be an opportunity over time for more of you to see ROSA in action and then you will be able to draw your own conclusions about some of the things that can really do it. I'm looking forward to that timing.
Bryan Hanson:
Yes. And I would just say one other thing too is, people are questioning whether or not with x-ray technology using this algorithm for 3D presurgical planning, so that we get the accurate cuts without controlling the saw-blade and in fact we're seeing is, we're getting more accurate cuts and people are pretty excited about that. At the end of the day, again traction feels very positive right now, and it gives me more confidence that even though we're going to have a great opportunity to get this mix shift in our own swim lane with surgeons that are using our implants today, I also truly believe that ROSA gives us an opportunity to go after competitive business. So we're going to get that mix benefit. We're going to make sure that our surgeons have access to robotics, but 100% guarantee we're going to go after competition here as well.
Coleman Lannum:
Next question please?
Operator:
Our next question comes from Mike Matson with Needham & Company.
Mike Matson:
Good morning, thanks for taking my question. Bryan, you've talked about your desire to pursue M&A to increase your WAMGR over the longer term, but it just seems like given the growth in a lot of the orthopedic markets and segments, there may be sort of a limit to how fast you can really grow if you still stick within orthopedics. So I guess I just wanted to take your temperature on your willingness to diversify and maybe do deals that are outside of orthopedics? Thanks.
Bryan Hanson:
Quickly, I would say on that, and then I'll get into little more of this, my preference would be to stay into the categories we already play and begin to try to double down in near adjacencies type plays, tuck-in type acquisitions to be able to build scale in areas we already play that are faster growth. So, I would be less interested at least in the short term to completely get into a new space right now. I think we have plenty of opportunity to be able to build scale in areas that we already play in and have a right to win and improving ourselves. So that will be the first thing. But just before I even get into to this idea of M&A, we will stay focused and I'd just say, yes I would like to use the word maniacally focused on ensuring that we do drive the near-term priorities. We are beginning to see stabilization in the base, we cannot lose that, as stabilization in the base has to be, there has to be our number one priority. But we're feeling better about that, there's no question. We are also working down our debt leverage now as we said that we would. We're being very focused on getting that debt leverage in the right place. Combination of those two things, more confidence in the core, getting the debt leverage where it needs to be, gives us better position now to be able to think about active portfolio management than in the past. But I don't want people to think that we're waiting to go buy companies to be able to drive our weighted average market growth up. As I've said before, we're already doing this. We're selecting the fastest growth submarkets that we play in today and we are systematically moving dollars to those growth drivers. That means, research and development, that means patient education, that means commercial infrastructure, and eventually when the time is right and asset is attractive from a returns perspective and it fits our strategy BD&L will file that as well.
Coleman Lannum:
Thanks Mike. Next question please?
Operator:
Next question comes from Richard Newitter with SVP Leerink.
Richard Newitter:
Thank you. I just wanted to ask another followup on ROSA, but more specifically what exactly is the - I don't want to use the word delay, I'm not sure if you had always intended to move into a full launch more in the first half of '20. But it feels like the ROSA one Spine product is getting pushed out a little further. Can you elaborate on what exactly, the prioritization issue was there and how we should be thinking about that rollout from either a sales force expansion ramp or is there a technological component to this that you need to redo on the system? Thanks.
Bryan Hanson:
Yes, it's a good question. What I'd say, first of all, is that we, from a commercial standpoint, we're leveraging the same commercial organization. So, we're building this robotics sales organization, it would have a component of it that would sell spine, brain or knee. So, we're able to leverage some of the brain infrastructure that we already had in robotics and we're just expanding that to be able to service each of these platform, so it's not so much on the commercial side. But the fact is, we did the, the limited launch, we came out with ROSA Spine and in that feedback process we received information on things that we could do to enhance the system, not necessarily the system itself, but the instruments around the system, and so we've been working on those enhancements and that's part of the reason for the delay. The other part is, when you're looking at getting these off the line, it's one line, whether it's a ROSA Brain, or ROSA Spine or ROSA Knee, it's coming off the same manufacturing line and we have biased our focus and resources to ensuring that ROSA Knee gets out of the gate strong. So that's just, we really have, we made sure that we, for all the right reasons focused a lot of our attention and getting those systems out first, But believe me, we have every intention of taking advantage of ROSA Spine and we truly do believe ROSA Spine is going to be an element of the turnaround of that Spine business, and we look at the first part of 2020 to start to move into that full launch.
Richard Newitter:
Thank you.
Coleman Lannum:
Thank you, Rich. Next question please?
Operator:
We'll take our next question from Robbie Marcus with JPMorgan.
Robbie Marcus:
Thanks for the question. Maybe just to followup on Richard's question here on Spine, this was one area of the business that came in a little weaker than expected this quarter. Can you help us understand some of the trends that are going on there, geographic differences, and how you expect this to trend for the balance of the year? Thanks.
Bryan Hanson:
Yes, truthfully, when I look at the overall Spine & CMF business, no one can be happy with the growth rates that we saw in the quarter. The only thing that gives me a little solace on this and should you as well, is that that deceleration as I've said from Q1 to Q2, was really a big portion of it was comps. I'm certainly not happy with the performance. We need to make sure that we do a better job there, but comps did play a pretty big role in that deceleration from Q1. That said, the thing that I would be most concerned about and I'm sure you are is, when are we going to see this thing turnaround. And as I've said before, I think first and foremost, we have to make sure that that commercial organization is gelling and that we have selected the right distributor partners. We made – we know the algorithmic decision and tribal knowledge decision on which distributors should be the ones that we land on, now we've got to make sure those are the right ones, and that's going to, that's going to take a little bit of time. Second piece is, we just talked about ROSA Spine, but we have applications in Walter, which is a mini robotic solution that can be by itself or it can be a complement to ROSA. We need to make sure that we launch that effectively as well and then we have some gap filling technologies, that we just haven't had in the bag, which has hampered our ability to be successful here that we're going to be launching as well towards the back half of 2019 and full launch into 2020. So, those are the things that need to come together for us to have success. And we're making the investment to do these things. We've got the team in place that says they can get it done. I've got to see it happen. And I wouldn't expect to see any inflection in this business that would necessarily say that you should expect as negative as Q2, but I wouldn't expect to see any inflection in this business until we get into that first part of 2020, probably even into the second quarter.
Coleman Lannum:
Thanks for that Robbie. Operator, we're going to try to get two or three more questions in for the part of the hour. Next question please?
Operator:
Up next we have Rick Wise with Stifel.
Rick Wise:
Good morning, everybody. I have a question for Suke. Good to speak to you again, welcome. Dan is a tough act to follow. He has done a lot of the heavy lifting in this initial turnaround phase. Maybe Suke you could just talk to us, one about to your initial impressions coming in? But more importantly, your priorities, the opportunities for this next phase, if you will, of the relay race to turn them around, get them up back on track, whether it's growth, or margins, or cash, what are your priorities? What should we be looking for from you as you stepped into the job? Thank you so much.
Suketu Upadhyay:
Yes, good morning, Rick. Thanks for the question. It's good to hear from you again, and you're right, there are big shoes to fill with Dan. He has done a lot as part of the overall turnaround and I feel fortunate to be joining at this inflection point. And as you said, Dan, along with the rest of the team under Bryan's leadership they have done a lot of heavy lifting already, but there is more work to do. And if I think about where the priorities are going forward, for me, just very tactically and acutely, there is a lot to learn about this business as well. It's a complex business with a lot of moving parts, especially in the backdrop of continuing to move beyond stabilization to growth. Two, I've got to get deeper into the organization to learn more about the teams and continue to build that relationship with the leadership team and more broadly into the organization, and really start to understand the culture, but then start to shape the culture as Bryan has been doing for the last several months. From a priority standpoint, the company has already gotten a number of initiatives in flight, and those initiatives, as Bryan has talked about, are hyper-focused on what I see is the key value driver of the company. One is around revenue growth across all the franchises. Two, it's around driving a leveraged P&L and margin expansion. Three, I think it's around making sure we have a top quartile free cash flow margin, as it relates to sales over time. And fourth, continuing to prioritize things that drive a very high and improving return on invested capital. So, I'm going to be spending my time on those initiatives that are aimed towards those four key metrics and we'll continue to evolve those as the market evolves and as our priorities evolve. But, I'm really excited and that's kind of how I see it, it's pretty basic, it's about blocking and tackling, and as I said, I think many of these things are already in flight, and that's where I'm going to spend my time.
Coleman Lannum:
Thanks, Rick. Operator, I know all the attendees have to get off at the bottom of the hour, they probably have a lot of oars to put in. So, let's just have one more question please and then we're going to wrap up.
Operator:
Up next we have Vijay Kumar with Evercore ISI.
Vijay Kumar:
Congrats guys on a nice quarter. A quick one from me, the investments that you've mentioned on the capital sales force, can you maybe qualitatively comment on is that, is that capital of sales force, is it doubling or tripling from these levels? Thank you.
Bryan Hanson:
I wouldn't get into specifics there, but I would just say that it's a significant increase in commercial infrastructure to make sure that we feel that we have the capacity, not from a manufacturing standpoint, but the commercial capacity to handle demand. And we will - again the beautiful thing about adding commercial infrastructure, if you've got your demand signal, right, which we think we do, there is a very quick payback on that. Also I want to make sure that I clarify that the capital sales organization is solely focused on getting the capital sold and placed and they are not going to have to be on an ongoing basis in the procedure. We truly believe that through the design requirements of our system that we have a system that does not have to have a separate representative in the operating room to run the system. We can use the implant rep to be able to do that. So the capital organization will be expanded to be able to drive the capacity for supporting the demand of the capital and our implant rep will be the one that will take over once the capital has been placed to make sure that this system runs well inside the procedure.
Vijay Kumar:
Thanks, Bryan.
Bryan Hanson:
Yes, thank you.
Coleman Lannum:
Thank you, Vijay. And with that, we're going to cut it off. I know there are number of other people in queue. As we've always done, if you didn't get a question in today because of lack of time we'll get to you at the top of the list for next time. Really, I want to appreciate your joining us. I know it's a Friday and it's been a long earnings week. As a reminder, you can listen to a replay of this call. It will be available later today for review. You can see that or listen to that on our website at zimmerbiomet.com. Have a great day. We will be talking to some of you later on today. Have a great weekend. Bye-bye.
Operator:
Thank you again for participating in today's conference call. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet First Quarter 2019 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today, April 26, 2019. Following today's presentation, there will be a question and answer session. At this time, all participants are in a listen-only mode. [Operator Instructions] I would now like to turn the conference over to Cole Lannum, Senior Vice President, Investor Relations and IRO. Please go ahead, sir.
Coleman Lannum:
Thank you. And good morning. Welcome to Zimmer Biomet’s first quarter earnings conference call. I'm joined by Bryan Hanson, our President and CEO, and our CFO, Dan Florin. Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. And, of course. actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please note that we assume no obligation to update these forward-looking statements, even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties in addition to the inherent limitations of such forward-looking statements. Also, the discussions on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within the earnings release found on our website at zimmerbiomet.com. With that, I'll now turn over the call to Bryan. Bryan?
Bryan Hanson:
Thanks, Cole. And thank you to everyone for joining us this morning. I'm going to provide a quick overview of our first quarter results, followed by an update on our short-term priorities. Dan will then provide additional color on our overall financial performance for the quarter. First quarter results were slightly above our expectations and, probably more importantly, further supports our ongoing confidence that we are making real progress in reshaping the business and positioning ZB for success. We delivered solid revenue growth, with another strong performance from our Europe, Middle East and Africa and Asia-Pacific region and continued improvement from our Dental business, which has been gaining traction over the last few quarters. We also continue to meet our short-term operational goals on our roadmap to go on offense in the back half of the year. importantly, we made further progress in positioning the organization to durably deliver our weighted average market growth of 2% to 3% in 2020. Our short-term priorities for ZB remain unchanged. They are supply recovery, shifting to supply efficiency; quality remediation, moving to best-in-class quality; new product launches, shifting to providing customer-centric solutions; and continued optimization of our talent structure; and then, finally, relentlessly driving a winning One ZB mission and culture. And I'm going to spend a little bit of time giving you an update on each of these priorities. Relative to supply, during the first quarter, we continued to shift our focus from supply stability to initiatives aimed at increasing our overall supply chain efficiency. And as we stated, supply is not a barrier to meeting our financial commitments or stated turnaround timeline. We see continued progress in our ability to regain the full trust of our commercial organization as we move to offense and focus on winning new business. Two catalysts in the quarter outside of product supply and new products that have helped drive field base enthusiasm were our 2019 sales kickoff meetings and the AAOS meeting in March. In both of these events, it was clear that our sales team is gaining both trust and confidence in their ability to win and in the support they are receiving from the ZB leadership team. Specific to quality, at Zimmer Biomet, everything we do is guided by our commitment to patient safety, quality and integrity, which is a primary principle of our mission. We made good progress on quality remediation in the first quarter. We remain on track to complete our detailed remediation plan on the Warsaw North campus by the end of the year, and we will be ready for reinspection within that timeframe. Going forward, we'll continue to shift our focus from quality remediation to building best-in-class quality systems and culture to ensure the sustainability of those changes throughout the organization. Relative to new products, 2019 will be an important year for Zimmer Biomet's pipeline and commercial strategy. In March, we showcased our latest products and offered a preview of our next-generation solutions at the annual AAOS meeting. We saw keen interest in both the existing and new technologies across our entire portfolio. There was a high level of energy at the booth this year from all of our key stakeholders, including surgeon customers, investors and our team members. We even had the FDA participate in a tour of the booth, providing an excellent opportunity for us to share our newest products and solutions with one of our key regulating bodies. The rollout of our ROSA robotics platform was clearly a major focus at AAOS. Over the past several months, we secured a number of important regulatory clearances for knee, brain and spine applications for our ROSA platform. We're now the only company that has robotic offerings across all of these areas. With respect to ROSA Knee, although it's early in the limited launch process, we have completed cases in all three of our geographic regions, and the response has been extremely positive. Through the surgical cases performed to date, our confidence is increasing that we can deliver all of the benefits of robotics that our customers have come to expect, while also allowing them to quickly obtain time neutrality in the surgical procedure with minimal disruption to surgical flow. We have seen tremendous interest from physicians and institutions, and that feedback increases our confidence that we have the right platform for growth in the second half of 2019 and well beyond. In addition to advancing our traditional products and portfolio, at AAOS, we also highlighted our integrated ecosystem of solutions. For example, and as I've mentioned previously, we have a unique opportunity to position Persona, ROSA robotics and mymobility, a digital health platform developed in partnership with Apple, to offer a more personalized and comprehensive robotic procedure and overall patient experience. With reference to our optimization of talent and structure, we have made good progress on our goal to become a more agile and results-driven organization. We continue to enhance the organization with new talent, to broaden expertise across the business and are receiving very good internal feedback on our new organizational structure that supports streamlined reporting and decision-making. Zimmer Biomet feels like a different company compared to a year ago, and you could definitely feel that at the AAOS meeting. We owe much of that success to open dialogue and transparency with the team. And as such, directly connecting with our team members will stay a top priority in 2019 as we continue to benefit from the energy and focus around the One ZB corporate mission and culture. We will continue holding mission ceremonies around the globe and let team members at every level know that leadership is behind them, and that we are as excited about the future as they are. These were our priorities in 2018 and will continue to be our focus areas throughout 2019. As we have consistently communicated, 2018 and 2019 are part of a two-year effort to reshape Zimmer Biomet and position us for offense and, ultimately, allow for durable weighted average market growth by 2020. As we enter 2020, our focus will shift to our new strategic pillars, which we introduced earlier this year. First, we will become the best and preferred place to work. We will make sure that people want to come to work every day because they believe in the organization and understand their direct connection to the mission, culture and strategy. Second, we will establish Zimmer Biomet as a trusted partner with all of our stakeholders, including customers, regulators, team members and investors. We want all of our stakeholders to know that they can count on us to do what we say and, importantly to do it in the right way. Third, we aspire to be a top quartile performer in terms of total shareholder return. As we continue to stabilize the business and begin to deliver consistent growth in 2020, we will be well-positioned to execute against a five-year plan that will accelerate revenue growth, drive margin expansion and increase free cash flow. Over time, as we execute in each of these areas, we will increase our financial flexibility and our ability to maximize shareholder value. And with that, I'll turn it over to Dan.
Daniel Florin :
Thank you, Bryan. Our financial performance in the first quarter was a bit better than our expectations. Also, as noted in this morning's press release, our full-year 2019 guidance is unchanged from what we provided during last quarter's call. Net sales totaled $2 billion in the quarter, a decrease of 2.1% from the prior-year period, with an increase of 0.7% on a constant currency basis. As we noted in our January call, while there is no impact on our growth rate from billing day differences for the full year, the first half of the year has about a day of headwind which is offset in the second half. The billing date headwind in the first half is spread fairly evenly between Q1 and Q2, but in the second half, the majority of the benefit will be realized in Q3. As Bryan noted, we delivered solid results in our O-US region. Within the quarter, our Asia-Pacific team delivered another strong performance with 5.6% growth, while our Europe, Middle East and Africa team increased sales by 1.5%. Meanwhile, the Americas region declined 0.9%, which was in line with our expectations. Consistent with previous comments, we expect our year-over-year revenue growth to accelerate in the second half of this year, driven primarily by contributions from recently launched new products. Moving to the income statement, we reported a GAAP diluted earnings per share for the quarter of $1.20. After adjusting for special items, our non-GAAP adjusted diluted earnings per share were $1.87. A reconciliation of reported net earnings to adjusted net earnings is included in this morning's press release. Adjusted operating margin was 26.6%, which was in line with our expectations for the quarter and gives us confidence in our full-year guidance of 27% to 28%. Net interest expense was $58 million, reflecting continued benefits from debt paydown. In addition, gains from our ongoing cross currency swap program were particularly strong in the quarter. The adjusted effective tax rate for the quarter was 17.5%, which is in line with our expectations and full-year guidance range for 2019. Operating cash flow for the quarter amounted to $284 million and our free cash flow was $182 million. In the quarter, we paid $168 million related to a patent litigation matter, which we discussed during our fourth-quarter call. This payment was included in our full-year free cash flow guidance of $1.1 billion to $1.3 billion. During the quarter, we paid down $110 million of debt and we continue to expect to use the majority of our 2019 free cash flow to reduce debt throughout the remainder of the year. With that, I'll turn the call back to Bryan. Bryan?
Bryan Hanson :
Thanks, Dan. we moved into Q&A, I want to say again that I am pleased with the steady progress the team has been making, our level of confidence has never been higher and our team members are more focused and engaged than at any point since I joined the company. This quarter, we delivered solid growth in important categories and geographies, while driving steady progress against our short-term objectives. We will stay relentlessly focused on those priorities as we continue to reshape Zimmer Biomet and position the business to drive growth in the back half of this year and into 2020 and well beyond. And with that, I'll turn it back to Cole to get into the questions.
Coleman Lannum :
Thanks, Bryan. Before we start the Q&A session, I want to remind you again to please limit yourself to a single question with a brief follow-up if and only if needed. Feel free to put yourself back in queue. Afterwards, I promise we'll get through as many questions as possible that way. With that, operator, may we please have the first question?
Operator:
Thank you, sir. [Operator Instructions]. We'll take our first question from Robbie Marcus with J.P. Morgan.
Robbie Marcus:
Good morning. And thanks for the question. Bryan, you hit on this a bunch of times in your presentation. I think for everyone who was at the AAOS analyst meeting that you held along with you and your team, it was pretty clear that Zimmer Biomet is making progress and you feel good about the business here. Can you just run through exactly what it is that gives you confidence here? Which of the business lines do you think is making the biggest progress forward? And how much of that confidence is driven by ROSA which, by all accounts, had positive physician feedback at the unveiling? Thanks.
Bryan Hanson:
Yeah. Thanks, Robbie. Yeah, I would agree. That's why stating it – and I think to your point, if you were there at the AAOS meeting, no matter who you were, it was palpable the level of energy that we had around our booth, around our technologies and just the general energy level of the team. So, it gives me increased confidence that we're absolutely heading down the right path. And I kind of break it down probably into two areas. The more objective side of things would be that we're delivering the financial commitments that we're making as a team. That's important, right? There was a lot of risk early on in this process. We've been burning down that risk and we've been delivering on our financial commitments. That is probably the most objective measure of whether or not the new culture that we're driving, the One ZB mission and culture is actually gaining traction. So, that would be the objective measure and that gives us confidence we can continue to do that. More from a, I guess, objective standpoint, we've done a lot of work around our primary focus areas. And I truly do believe that that's going to start paying dividends and we're feeling it already. You could feel it at the AAOS meeting. We are, every quarter that goes by, retiring risk associated with supply stability, with quality remediation and launching our new products. Obviously, you saw that again at the AAOS, ROSA being a big part of that. One ZB mission and culture, I know I talk about it a lot, but it's gaining traction. And I think it was very apparent at AAOS. People are feeling energized beyond a year ago. And I think the new talent and the structure that we put into place is making people feel better about the energy level in the leadership team, particularly the connection between the leadership team and the commercial organization, which I think was very apparent at AAOS. So, those are softer side of things. A little more subjective, but you can just feel it. People are ready to win. And I think what's important – and again, some people kind of laugh at me when I say this, but there is a real belief that we are going to win. People truly do believe it's going to happen. And there's this kind of mantra that's going around, and it was very heavy at AAOS from our team that this is the year that we prove everybody wrong that doubted that we could return as an organization to where we used to be. You just picture that in a locker room heading out to a game where you're going to prove everybody wrong, and that's basically what we have right now across this entire organization. And it just feels good. It feels right. And the plan is coming together. So, the energy you felt at AAOS is real, and it's taking us down the path that we thought it would. But we're just as excited either way.
Robbie Marcus:
Thanks a lot.
Coleman Lannum:
Thank you, Robbie. Next question please.
Operator:
We'll take our next question from Matt Taylor with UBS.
Matthew Taylor:
Good morning. Thanks for taking the question. So, Bryan, I wanted to get some of your updated thoughts on ROSA. There is a lot of investor focus on that. You had a good showing at AAOS. And talk about a lot of leads that you generated. So, I don't know if you can comment on how some of those leads are converting or the interest you're seeing or any color on how we should expect this to roll out during 2019 would be helpful?
Bryan Hanson:
Yeah. Absolutely, Matt. So, we did receive a lot of leads. That was one of the things we're most excited about at AAOS. It was a dramatic change from a year ago at AAOS. We had less than 100 leads a year ago. And the AAOS this time, we had basically 2,000 leads. Now, the hard work begins. Once you get the leads, you've got to actually do the disciplined work to make sure that you're segmenting those leads and getting on top of them, which we are. And a decent portion of those were, as one would expect, on Rosa. So, I would just say, on ROSA specifically, since that's your question, it's obviously very early in the game. We just launched the product. We're just in limited launch. But I can just tell you, the initial response and just general interest level in the system is very positive, as positive as I've ever felt in a product launch. It's not necessarily a surprise to us. We had a specific development process that allowed significant engagement with surgeons along the way. I don't know if people are familiar with it, but it was the Agile method of development for the system. What this basically means is you do quarter sprints from a development perspective and each quarter you're bringing in surgeon partners to be able to look at what you've done, basically beat you up on what they don't like, and then could do another quarter sprint to make those corrections. What I like about it is you're getting constant surgeon feedback and you're also creating urgency every quarter because you're in a sprint every quarter. So, it's a great development process. So, I guess, what I'm saying here is it's not a surprise to us that it is being well received because we had surgeon engagement throughout the entire development plan. What I would tell you, though, now that it's being used and used across all of our geographic regions, in real-world, we're getting same feedback around the design principles that we put into place. Some of the things that we're hearing consistently is that people do like the fact that they do not have to use CT for preoperative planning. Let's face it, you don't have to have CT in the patient journey today unless you're using certain robotic systems. So, it disrupts the patient journey and people would prefer not to do that if they can help it, while still getting the accuracy which is again the feedback that we're getting. Others have told me in that CT area that they don't want to expose patients to unneeded radiation. So, they like it for that reason. Big one that I'm hearing is on surgical flow. This is one of the design principles. We wanted to make sure that high-volume surgeons could use robotics in every procedure and it would not slow them down. And we're hearing that real-world. It's happening. In a very short order, using the robotic system, they're getting to time neutrality in the procedure, which is a big deal. Remember, we want to focus on high-volume surgeons because we get that mix benefit every time a surgeon uses the robotic system. Other things that we're hearing is around the accuracy data that we're sharing with our surgeons, extremely accurate system even using x-ray imaging for preop planning. And we don't talk much about it, but you think about the genesis of the robotic system, it started in brain, which has intense need for accuracy. So, we have something called dynamic tracking which allows the robotic system to stay registered with the patient even when the patient with a robotic system is moving. That's a big deal. Because if the knee moves in a procedure, our robotic system knows where it is versus the knee and still provides the accuracy in the cut. Other systems don't do that. So, we're getting feedback on that now as well. People didn't recognize the value of it, but we're clearly hearing that. Probably the biggest one that was obvious to us is that surgeons get to use any system they know and love. So, they can keep the knee system they love, they've been using forever, they have trust in and use the ROSA robotic system with that. So, again, my enthusiasm is pretty high probably hearing it. You certainly heard it at AAOS. It's growing as a result of the feedback that we're getting. I do want to couch it, though. I'm a pretty enthusiastic person when I talk about new technologies. You're going to hear the same thing from my people. I've already seen some of you go out and talk to surgeons. You're hearing that from surgeons. But this was expected. It was expected. It's good to know that we're validating that expectation, but that enthusiasm, that response from our surgeons was assumed in whatever guidance we've provided in that turnaround time line we're talking about in 2020. So, I want to make sure you're not mistaking my enthusiasm for something that says we're going to change our guidance or we're going to change our view of the turnaround. It was already incorporated into it. But out of the gate, couldn't be happier.
Matthew Taylor:
Thank you for all the color.
Coleman Lannum:
Thanks, Matt. Next question please. Our next question comes from Pito Chickering with Deutsche Bank.
Pito Chickering:
Good morning. Thanks for taking my question. You talked about having sort of price and mix issues relative to some competitors. If you look into 2020 and get back to 2%, 3% market growth, how much of that revenue is coming from positive mix shifts from new products like cementless knee or ROSA and how much of that cut [ph] is coming from capturing lost market share?
Bryan Hanson:
You want to make sure that I understand your question. You're asking how much of the revenue growth that we see on a go-forward basis would come from share gain, actual volume, procedure gain or mix shift? In other words, getting higher price points. Okay, I got you. Without getting too specific, what I would tell you is that when we think about the turnaround of the business, it's, obviously, multifactorial. We're going to have a bunch of different things that will drive it. But, definitely, one of the big variables associated with our driving revenue growth will come from revenue mix shift as a result of bringing new technologies into the market that are higher price point than previous technologies and/or add incremental disposable cost to the procedure because of the value that they bring. So, I'm not going to get into the specifics of what level of penetration we're going to get in robotics or cementless or those types of technologies and not even talk about the percentage of the overall growth. But just know that will be a material part of our growth on a go-forward basis. That mix benefit you get when you bring new technologies in. What we love about this is, with these technologies that bring real value for our patients and our customers, you don't have to have a new patient, you don't have to have – convert a new surgeon. You just need to have the same surgical procedure, with the same patient, with the surgeon you've always had upsold to better technology. And when that occurs, you get more share of wallet. You get more revenue per that procedure. And that is absolutely something that we're going to concentrate on. At the end of the day, it is the path of least resistance. There is less change that needs to occur in that path. So, it will be something that we concentrate on. At the same time – as I said, it's multifactorial – we're definitely going to pursue converting business. We're going to try to convert the other guy's business. But even if we stayed – I guess, the point is, even if we stayed in our swim lane, which is a pretty wide swim lane, by the way, we have a real opportunity to drive revenue growth just through that mix of revenue shift.
Pito Chickering:
Great. Thanks so much.
Coleman Lannum:
Thank you, Pito. Next question please.
Operator:
We'll take our next question from Vijay Kumar with Evercore ISI.
Vijay Kumar:
Hey, guys. Thanks for taking the question. Bryan or Dan, I just want to go through the guidance, the first half versus second half. Some helpful commentary here. So, the guidance for the year, on a constant currency basis, 50 to 200 basis points. That's the range. You just did 70 basis points in Q1, inclusive of [indiscernible]. That includes 100 basis points of impact from days, the one half versus second half. Just looking at the comps, it feels like first half is going to be flattish organic. The days itself should give you guys, back half, at least 150 to 200 basis points, the first half versus second half. And should we be thinking about new product contribution over and above that. And as we think about new products, would you be giving us a system placement numbers on ROSA, et cetera, going forward? Thank you.
Bryan Hanson:
So, we're not going to give – just the last question first, I guess, we're not going to give a lot of detail relative to surgeon training, system placements, those types of things. Not because we don't want to divulge it to you, but more than anything, we just don't want to send any clear messages to our competition on the level of traction we are or not getting with that system. So, I just wouldn't expect that level of disclosure from us when we talk about robotics. When I think about the back half of the year, there's a couple of things that are happening when you move from first half to second half. The first half of the year, we have a negative headwind on the billing day, which we've talked about which is pretty evenly split between first quarter and second quarter that reverses in the back half. And as Dan mentioned in the prepared remarks, there's probably a little more benefit in the third quarter than the fourth quarter. But, certainly, that's a positive movement as we come into the back half as you referenced. We're going to continue to have bone cement headwind in the first half and we'll have that in the second half as well. Should start to wane more in the fourth quarter because you're going to have some of that already built into the comps from prior year, but that would be another element that we would consider in the back half. And then, when we move from limited launch to more full launch in the back half, that's obviously a benefit. So, yes, all three of those things, particularly on the billing day change and the limited launch moving to full launch, should be thought of, and included in, the expectations for the back half of the year. Remember, though, that all of this is captured in a very clear message that we're sending that, by 2020, we expect all these things to come together and allows us to deliver 2% to 3% which is our weighted average market growth in a consistent way. So, you can just kind of work the math on what we would need to be doing when we exit the back half of the year to be able to make that more predictable.
Vijay Kumar:
Thanks.
Coleman Lannum:
Thanks, Vijay. Next question please.
Operator:
Our next question comes from Steven Lichtman with Oppenheimer.
Steven Lichtman:
Thank you. Good morning, guys. Bryan, again, I was wondering if you could talk a little bit more about the shift to manufacturing efficiency that's underway. What are the opportunities that you see to gross margin expansion? I know that you're targeting that more so in 2020 as the benefits flow through COGS.
Bryan Hanson:
What I might do is maybe just kind of hit the top-end view of the activity around it and then, Dan, if you want to provide color beyond that, no problem. We've talked a lot about this as an organization. We have not had a lot of focus unfortunately over the past few years on cost down, real discipline in margin expansion in our manufacturing facilities because we've been over-indexing on quality remediation, we've been over-indexing on making sure that we have supply. So, unfortunately, that's where the energy is going, not on disciplined cost-down in manufacturing. Now, as we brought the new leadership in to operations, we've been building that muscle and the function, actually adding people around operational excellence, to be able to get after those types of projects. That team really just got put into place at the end of 2018, just starting to get traction and get a pipeline of projects in the first quarter here in 2019. And the real goal is to look at the obvious – look at the obvious areas of opportunity to drive margin expansion. That's what they're focusing on. Just regular, good old fashioned cost down, looking at our suppliers to be able to drive efficiencies there. Eventually, we'll get into footprint consolidation, but that takes time. We'll get into value engineering and those types of elements as well. But we are finally getting more discipline around the team in place, the pipeline of projects to put in place to be able to get after margin expansion and the operating mechanisms to ensure that it occurs. Now, just to set the right expectations, this will take a while for those projects to get in to play, start to materialize and then capitalize into the gross margin impact that we have. Remember, it's a year or so of capitalization for us. But I'm excited to see the momentum. I'm excited to see the team in place. It's just going to take a while. First and foremost, we need to make sure that these projects begin to offset the headwinds. We have pricing pressure every year. We have raw material increases every year and these projects need to begin to offset those first and then get after actual margin expansion.
Daniel Florin:
This is Dan. I guess what I would add to that, as Bryan was saying, gross margin is multifactorial, right? You've got pricing. You've got cost. You've got mix benefit. And in my prepared remarks, I talked about, in Q1, the foreign currency hedge gains that we experienced. So, when you think about our gross margin rate in 2019, we are going to see some benefit to that rate as a result of our foreign currency hedging program. You should expect, really because of that, to see our gross margin rate in 2019 to be slightly higher than 2018, again, really driven by that FX hedge gains. And we've talked a lot about investing in SG&A on the other side of that. So, it kind of offsets that elevated gross margin rate. With respect to – as Bryan was saying, the manufacturing cost, our manufacturing costs remain under pressure. Have a lot of confidence in the new team for getting after it. It will take time to spin up those programs and execute to those. And then, it will take time to come through the P&L. But, again, the message is the team is managing through that, and all of that is inside of our guidance.
Steven Lichtman:
Thanks, guys.
Coleman Lannum:
Thanks, Steve. Next question please.
Operator:
We'll take our next question from Josh Jennings with Cowen.
Josh Jennings:
Hi. Good morning. Thanks for taking the question. I wanted to follow up on Steve's questions just on margin expansion, but kind of moving down the P&L. I think, Dan, you committed to some level of margin expansion in 2020. I know we're a little bit early here to talk about 2020, but I was hoping you could just help us understand some of the puts and takes with that commitment as we get into next year. And just how dependent on volume growth is margin expansion in 2020 in terms of getting back to that average weighted market growth rate of 2% to 3% on the top line? Thanks for taking the questions.
Daniel Florin:
Sure, Josh. We're obviously not going to give 2020 guidance here. We are confident that our operating margin expansion for 2020 is as real today as it was at AAOS when we mentioned it in prior quarters. And just know it will be a full program that looks at operating margin expansion. There is opportunity to continue to invest in the business, while driving margin expansion. So, I wouldn't get too hung up on the geography of that in the P&L. Just know that it's an area that we're focused on and we don't see it as mutually exclusive with growing the business either. Based on what we're telling you about top line acceleration back half of this year and our growth expectations towards our WAMGR in 2020, that gives us an opportunity to drive some leverage, but at the same time taking some productivity initiatives and driving those through 2020. I think the last piece I would say is there is a real opportunity in the spirit of the portfolio management that we've talked about of taking existing spending and just making sure it's pointed at the right places to drive our WAMGR out. And there is a nice opportunity to do that. So, we're focused on this in a big way as well as growing the business and delivering on our new product launches.
Coleman Lannum:
Thanks, Josh. Next question please.
Operator:
We'll take our next question from Chris Pasquale with Guggenheim.
Chris Pasquale:
Thanks. Bryan, I was curious how the reception has been so far to Persona cementless. And is that a product that you guys expect to ramp relatively quickly because of the increased comfort surgeons have gotten with cementless implants over the past few years or do you think your customers are going to want to see more of a track record with that specific implant?
Bryan Hanson:
Yeah, thanks. So far, so good, I've got to tell you. Again, it's relatively early on still, but we're getting great traction. And I can think the fact that cementless is taking off with other companies, that's leading the path, if you will, and the confidence level is higher and the acceptance is higher as a result of that. Sometimes, it's okay to be second to the party because you get to take advantage of who got there first. And that is exactly what is happening. I do believe that people have immediate confidence with our cementless option because, remember, it's Persona, which they have grown to know and love, it's one of the best, most personalized knee systems you can get at a reasonable cost, is giving the anatomical correctness and the size options that you've got, but it also has Trabecular Metal, which has just been studied and known to have some of the best bone in-growth you're going to get with the material on an implant. So, it's a combination of those two things in the Zimmer Biomet that is giving people the confidence to move in that direction. So, we're as excited as we've ever been with cementless and we expect to continue to move down the path of getting conversions there. We haven't given specifics relative to the expected penetration of our cementless versus just the total knee, but we certainly believe that we've got a lot headroom there still.
Chris Pasquale:
Thanks.
Coleman Lannum:
Thank you, Chris. Next question please.
Operator:
Up next, we'll go to Craig Bijou with Cantor Fitzgerald.
Craig Bijou:
Great. Good morning. Thanks for taking the questions. Appreciate your comments on the supply side. And then, Bryan, looking ahead to 2020 and as the business continues to accelerate, I wanted to ask you, what's your level of concern or how should we think about potential risk that you'll have enough supply to meet the demand for, say, the four new products – four new knee products? And maybe, more specifically, as the industry is trending towards cementless, do you have any concerns if cementless ended up being 10% of your knees in 2020 that you can actually meet that demand?
Bryan Hanson:
So, I would tell you, just given some of the supply issues that we've had in the past, our discipline and operating mechanisms around ensuring that capacity planning is done appropriately is probably never been more acute or more focused. I personally have a weekly call with my team to talk about where we are with capacity planning, with the processes and how we're doing relative to certain metrics that we have in place on improving our service levels to customers. So, there's an intense focus, as one would imagine, on ensuring that we get it right relative to the forecast, that we get the demand planning signal correct in manufacturing facility and, ultimately, the capacity would be there. I feel very confident that we have the capacity planning in place with all new products to ensure that we can deliver on the financial commitments that we've talked with some headroom. We're not going to take the chance of not having that headroom. What I would tell you is that we still need to move to a better, more automated process. It's still pretty manual. That's one of the things from a systematic standpoint that we're doing this year, rolling out a more integrated business development planning process that will create a more automated, end-to-end demand planning process that we don't have today. But the level of work, attention from the senior-level parts of the organization on this demand planning process is probably more aggressive than I've ever seen anywhere for good reason, obviously.
Craig Bijou:
Thanks.
Coleman Lannum:
Thank you, Craig. Next question please.
Operator:
We'll take our next question from Larry Keusch with Raymond James.
Larry Keusch:
Thanks. Good morning, everyone. Bryan, I just wanted to touch on one item here sort of bit strategic. So, now that the business – there are signals in the business that is beginning to stabilize and I know you guys are always looking at all facets, but when is it appropriate to start thinking about getting active in M&A or portfolio pruning. Just trying to calibrate sort of expectations for when that really becomes a major focal point for you guys as I assume you're really not focused right now on just sort of stabilizing the business, getting supplied, getting new products out there. And then, just quickly, secondarily, I was just trying to get a sense of the impact of the bone cement in the first quarter. Really just trying to understand what the underlying constant currency growth of the business is.
Bryan Hanson:
I got you. So, I'm just going to hit the bone cement first because it's a shorter of the two. Bone cement was pretty much – even though the other category looked a little better than I think what some people expected, bone cement was right in the sweet spot that we had referenced, between that $10 million and $15 million. It was on the lower end of that, but it was in that range. The only reason why other looked a little better than that is because we had some literally other categories of other do a little better and offset it. But I would want you to continue to think about bone cement headwind in that $10 million to $15 million range. That would be an important key message there. When I think about this idea of more active portfolio management, I just want to make sure that I continue to say this because it's for me personally from a discipline standpoint and to my organization and a good reminder for you guys as well. We will be, what I always like to say, maniacally focused on our near-term objectives throughout 2019. We've laid those objectives out very clearly, that they are a part of 2018, part of 2019. I just don't want the organization to lose focus in those areas. It's very easy to start chasing other things because they're exciting, but we just need to be back to the basics, disciplined, delivering on supply, making sure that we get the quality movement that we need, transitioning the new products to more total solutions, driving that One ZB mission and culture, and ensuring that the talent structure begin to gel. Those will be the focus areas. At the same time, Dan alluded to this, we're not just sitting and waiting to drive our weighted average market growth up. Even in areas that we already play in, like knee, that is a relatively low growth area, we're already shifting resources, focus and mind share to the fastest growth submarkets of knee. Robotics as an example, cementless as an example. If I take the same view of spine, spine overall is not an overly attractive space, but if you look at MIS, you look at robotics, you look at cervical disc, those are very attractive submarkets. So, as we become more disciplined, which we're already doing, not just selecting markets, but also selecting the more attractive submarkets and then move R&D, commercial infrastructure, commercial focus, training and education and, eventually, business development because that's where we want to go. My preference would be to focus on stability of the core and then begin to move more aggressively into business development in those areas that are going to be attractive to our WAMGR. So, I guess, short story is, we're going to make sure we stabilize the business, but as we continue to do that, particularly as we come into 2020, you're going to see us be more aggressive in business development to be able to drive WAMGR up with a precursor that we need to make sure that anything we pursue is strategically relevant to us and we can bring good returns for you and for us.
Larry Keusch:
Great, thanks.
Coleman Lannum:
Thanks, Larry. Next question please.
Operator:
Our next question comes from Bob Hopkins with Bank of America.
Bob Hopkins:
Thank you very much. Just one quick question on ROSA. Really on the capacity front. I'll limit it to kind of 2019. So, I guess, the one question is, how much of a limiting factor is capacity. Just maybe qualitatively, can you give us here a sense of where you are on capacity for ROSA broadly. I am speaking for both total knee and for spine.
Bryan Hanson:
Yes. I would say that you are the best at extracting information that I don't want to give. I've got to prevent you [ph] ask a question. You've asked me this a few times. What I would tell you is that I probably – you said more than I already should relative to capacity on ROSA Knee, in particular. So, I probably won't speak any more to it because I don't want to send any clear messages to my competition. I think the simplest way to say is that I feel very confident that we have the capacity required to deliver the financial guidance we provided and absolutely to be able to deliver what we have provided you for 2020. And believe me, with the level of interest that we're getting in the ROSA system, particularly on the knee side right now, just given where we are in that launch process, we're putting a lot of effort into making sure capacity is not something that's going to keep us from taking advantage of that technology. Same thing for spine, by the way. The beautiful thing about the robotic platforms that we have is that they're very similar, whether it be brain, whether it be spine, whether it be the knee application, they're coming off the same line. So, we have the opportunity as we scale up to ensure that we have the capacity for all three of the robotic solutions that we provide. So, I guess, short story, robotic capacity is not going to be something – let's hope we're complaining about robotic capacity. That will be a good signal.
Bob Hopkins:
Great. Thanks, Bryan.
Coleman Lannum:
Thank you, Bob. Next question please.
Operator:
Our next question comes from Rick Wise at Stifel.
Frederick Wise:
All right. Good morning, Bryan. Can you maybe give us a little more color on the ortho market as a whole? I was curious, was first quarter – we have three big players reporting so far. Was first quarter market growth worldwide as you expected generally? Our read is that worldwide hip/knee market was in the 2-percent-ish range, maybe a tad slower than a year ago. So far, it seems like hips are growing faster than knees. Just wondering what that says about your view of the 2019 market backdrop as a whole and as you're thinking about the rest of the year. Thanks.
Bryan Hanson:
Yeah, absolutely. I've said it a lot and it is because I truly do believe it. I don't really put a lot of weight into what happens in a single quarter. There's just too many moving variables. It could be – for any organization, positive or negative comps, they could be running through with billing day differences. There's just a lot of things that could happen inside of an individual quarter. But just if I break it down based on the way we've analyzed it, I don't really see any material impact, up or down, to the quarter so far, the first quarter. And certainly, from our assumptions that we built into 2019 as we put on our guidance, we pretty much expect 2019 to look a lot like 2018 and 2017. There is always slight variation, obviously. But we're expecting 2019 to look pretty similar to 2018 to be honest now. Hoping we're wrong and the volume is better than that. That would, obviously, be a positive for us. But I'm not seeing anything that would indicate to me that we're going to see any kind of a material increase or decrease to volumes. They look pretty consistent to me.
Frederick Wise:
Thanks.
Coleman Lannum:
Thank you, Rick. Next question please.
Operator:
We'll take our next question from David Lewis with Morgan Stanley.
David Lewis:
Thanks. Just one question from me. Bryan, I want to come back to ROSA. And I think you've been very clear that, competitively, we're not get the information we want as it relates to utilization, system number, things like that. I wonder if you could just share with us how you're going to sell the system, whether it's going to be usage based or capital sale? And I'll tell you the reason I ask. I think there is a lot of enthusiasm around ROSA. And to the extent that investors believe you're going to sell this as a capital sale, that's going to drive near-term revenue expansion for the business a lot faster than potentially a usage-based agreement and that's going to lead to a disconnect towards the back half of the year and into 2020. So, of all the details I think we need, the one that would be most helpful is how you're going to sell the system, capital versus usage, and any mix dynamics you can give us as it relates that or early feedback you're getting from customers as it relates to how they want to purchase the system would be super helpful. Thanks.
Bryan Hanson:
Yeah, absolutely. And, obviously, it's dynamic. It depends on the customer that you're speaking to. And we've been a little more transparent here, obviously. It's been pretty well noted that when you look at the robotic pricing, the list pricing that we have, it's over $1 million. That's been very clear. It's out there. At the same time, we're going to be – we're going to give a number of options for our customers to acquire a system. We're going to be flexible based on the business needs or requirements of that customer. You've got to remember that our primary focus is really to drive the robotic procedure. The capital sale is fantastic. Love to get it. Anybody would like to have that. It's a nice pop in the beginning. But driving robotic procedure adoption is the annuity that all of us want, right? It should be. It should be the most important thing. By doing so, I actually believe that we're going to increase the accuracy of the procedure for the patient and the surgeon, which is the obvious mission-centric reason for doing this. And then, we'll automatically, as a result of that, benefit from the mix benefit associated with the robotic case because of the disposable pricing and some of the halo effect you get on your implants. So, again, that will be our primary focus, is to push robotic procedure adoption. So, we're going to be flexible with our customers when it comes to making robotics attractive. At the same time, we're going to ensure that we capture the fair return for the value that we're providing. Let's face it, again, there's a benefit to coming second to market here. The market is clearly speaking to us. And it is clearly indicating that a premium is expected, should be expected for the value that robotics brings. And we're not going to let that premium go. We may be second to advance here, from my perspective anyway, but we have a great robotic system that's getting great reviews from our customers and we are going to make sure that we don't come in at a discount to the market. So, when you think about capital purchases from us and the price point that we have, we shouldn't be thinking about us because we're second coming in at lower than the market premium that already exists. I'd say the same thing for the disposables. We haven't given specifics here, but we truly do believe there is value in using robotics. The market is speaking to us, saying that they're willing to pay a premium. And one should expect that our disposable premium would be similar to what the market is bearing right now. We don't see any need to come in at a lower price point. We think we've got a competitive solution and we don't have to do that.
Coleman Lannum:
Thanks, David. Next question please, operator.
Operator:
We'll take our next question from Larry Biegelsen with Wells Fargo.
Lawrence Biegelsen:
Good morning. Thanks for taking the question. Bryan, I wanted to ask about a business that I don't think has come up on the call yet. That's the S.E.T. business. The questions around that are, one, what's the status of the Sidus stemless shoulder rollout and what are your expectations for that business? That's a higher growth segment of orthopedics. So, what are your expectations for that? Thanks for taking the questions.
Lawrence Biegelsen:
Yeah. We've been happy with some of the progress that we're making in S.E.T. as a whole. Obviously, when you think about S.E.T., not all the subsegments of S.E.T. are created equal in our mind. One of the more attractive subsets of S.E.T. would be that upper extremity shoulder is – obviously, it's an area that we focused in the past. We have good market share and we expect to continue to focus. And the stemless shoulder that we have is an attractive option. We talked a lot about in the knee looking at robotics or cementless as an opportunity to increase share of wallet or get that revenue mix benefit even with the same patient, even with the same surgeon. The Sidus stemless shoulder is the exact same thing. We've got an opportunity to bring a unique solution or a better solution to our patient and to our customer and, as a result of that, get an increase in price point for that stemless shoulder. And, certainly, that is what we're doing. And the response so far to our technology has been very good. It's one of our major focus areas in the shoulder area and overall set and we're going to continue to focus on it. We're not going to give specifics relative to the penetration of it, but just know any area that we have that we can sell to get an upsell relative to the share of wallet we get in the procedure will be a concentration for us.
Lawrence Biegelsen:
Thank you.
Coleman Lannum:
Thank you, Larry. Next question please.
Operator:
We take our next question from Kristen Stewart with Barclays.
Kristen Stewart:
Hi. Thanks for squeezing me in and really excited that the call had no drops so far. Hope I don't jinx this. But I was wondering if you could comment at the outcome of the pricing dynamics in the quarter. It did look like pricing did dip down a little bit below the levels from 2018 that we saw. And I appreciate that there's always this volatility in price quarter to quarter. So, I don't want to make too much of anything over one singular point. But how do you just think about pricing going forward for the overall business? And how do you kind of think about that as you're looking ahead? At what level of gross margins do you think you can kind of come back at since – the hope would be, with all the cost initiatives that you're starting to work on, that obviously margins could potentially move higher. I just want to make sure that that's kind of how we should be thinking about it or is it just kind of running to standstill because of the price environment? Thanks.
Daniel Florin:
Kristen, it's Dan. Pricing in the quarter, frankly, was right in line with what we expected. 2.6%, very consistent with where we've been in 2018 and 2017. 2018, in the fourth quarter, we did have that rebate adjustment in Europe that – so if look solely at Q4 of 2018, it's little bit of an artifact inside of that that lowered the price decline. But 2.6% for total ZB, very consistent with where we've been. So, there was nothing across products or geographies that was really out of trend. And we continue to view that as the price erosion going forward. Certainly, as Bryan was describing, the new products that we're launching come at price points. So, we're clearly going to be looking for positive mix on a go-forward basis. There's clearly that opportunity. But in terms of like-for-like price declines, in the aggregate, very consistent. I think with respect to pricing and gross margin, just a brief comment there. That is an annual headwind against gross margin. So, as Bryan was referring to, just to keep gross margin flat, you need to be taking aggressively cost out of your manufacturing cost base or you're losing ground. And as we get further into 2019 and start talking about 2020 and beyond, we'll provide more color. But the point there is you have to be aggressively taking cost out just to stay even. And we're going to look to drive positive mix as a benefit to gross margin over the long run.
Coleman Lannum:
Thanks, Kristen. Next question please.
Operator:
Our next question comes from Jeff Johnson with Baird.
Jeff Johnson:
Thank you. Good morning, guys. Bryan, maybe back on geographical comment. Asia-Pac has been solid now for three years running for you guys. Just how do you feel about the consistency of that going forward? And is the way to think about the improving growth rate overall for the company that that holds steady and then the Americas growth is what kind of improves over the coming quarters as a mix driver of the improved growth? Thank you.
Bryan Hanson:
Yeah. So, what I would say, I'd like to see all geographies, all businesses improve. I don't care how good they are right now. I think there's an opportunity for us as we roll out new products, as we change the culture of the organization, as we change the discipline of the organization and kind of this accountability – extreme accountability culture we're trying to try drive. I think everybody can go up. So, I'll just state that right out of the gate. I think what I love most – and I'm just going to give a shout out to the Asia-Pacific team. That's the mentality of that team. Even with the performance that they have had, they're happy about it, but they're never satisfied. They've never satisfied with what they're delivering. It doesn't matter if it's over market growth. They're always looking for ways to be able to drive it even further. And that gives me confidence that that Asia-Pacific team will continue to deliver. You're always going to have quarters that are up and down, anomalies in the quarter. When I think about that APAC team, the leadership capability, their proven track record, I have confidence they're going to continue to deliver for us. At the same time, I have confidence that we're seeing that same level of traction across all of our businesses and regions. I truly do believe we're getting into a place now that gives us an opportunity for any one of our businesses or regions to be able to perform. And that's when success occurs when we have that durability across the businesses and we have that ability for one to help the other in a specific quarter. It's that balanced selling that will really drive the durability of our overall growth. So, I truly do believe that Asia-Pacific will continue to do what they've been doing, but I fully expect the other regions and businesses to do the same.
Jeff Johnson:
Thank you.
Coleman Lannum:
Thanks. Operator, we're getting close to bottom of the hour. Let's see if we can get at least a couple more quick ones in please. Next question.
Operator:
Thank you. Our next question comes from Kyle Rose with Canaccord Genuity.
Kyle Rose:
Great. Thank you very much for taking the question. I just wanted to circle back on ROSA here. And, I guess, just starting off, I guess, how would you characterize the low-hanging fruit, meaning interested accounts that want to buy a robot in the near term? And then, secondly, the other major robotic player that's frequently talked about robots in a competitive account, presumably at 40% market share for Zimmer. Some of those accounts that the competitive robots have gone into are probably historical Zimmer accounts. So, when I think about your first second year robot placements, you expect to see more de novos or new robotic customers? Do you expect to see competitive swap-outs or just accounts buying multiple different types of robots? How do you expect this market to evolve over the course of the next one to two?
Bryan Hanson:
Sure. What I would tell you, just first of all, our strategy is going to be, first and foremost, as we've done better account segmentation, is to focus on what we're defining as platinum accounts. And a platinum account would be – and there's more than 700 of them that we have just in the US alone, for instance. Platinum account is where it's a high-volume account. So, it's got be a very high-volume account where we have the largest share position in that account. Those will be the accounts that we go to first to be able to get a robotic position because, in the past, those very accounts, if they wanted to move towards robotics, it couldn't be us because we didn't have that solution set. So, when you do hear our competitor talk about placing in competitive accounts, those are probably the types of accounts that they're talking about. Our first goal is to make sure that we stabilize those accounts, we bring robotics in. And even where we have the lion's share of the business, there's still upside, we make sure that we get after that additional upside as well. So, the platinum accounts where we have high-volume, we have high share will be where we go first. Once we get through the limited launch and get into full launch, deeper into full launch, we'll be looking at gold accounts which should be high-volume accounts where the other players have more share than we do. And certainly be looking particularly in those accounts where the high share players don't have robotic solutions, that will be the next tier of our focus. The beautiful thing that we have here is that we've got very low penetration of robotics in overall surgical procedures today. So, anyone who has a good robotic solution and the implants to surround it, really has an opportunity to benefit from increased adoption of robotics. We think we're going to be able to differentiate because we're not just bringing robotics, we're bringing robotics with mymobility, which is that digital health platform backed by Apple. We're connecting that with Persona, which is a more personalized implant. So, we really do believe that kind of this connected ecosystem that we're providing is unique to us and will continue to benefit us or will start to benefit us.
Coleman Lannum:
Thanks, Kyle. Let's see if we can squeeze two more in here really quickly, operator. Next question please.
Operator:
We'll go to Richard Newitter with Leerink.
Richard Newitter:
Thanks for squeezing me in. Bryan, just a quick question to follow-up on the last one on robotics. How can you leverage your ROSA Brain robotic platform footprint, particularly on the spine side, now that you're approved in spine to kind of target accounts? Can you remind us what the installed base is for brain in the US and worldwide? And how does that potentially provide you leg in the door for robotics in spine in particular?
Bryan Hanson:
First of all, thank you for asking about ROSA Brain because that's where it all started. And it absolutely is a benefit and a catalyst to us when we think about the spine side. I was just in an account two nights ago having dinner with some folks. They were looking at bringing in three robotic solutions for the spine side of their business. We're not even thinking about us because we just got approval. They were thinking about two other players that are out in the marketplace. But I also found out that they were looking at bringing in a brain system as well. And so, when they found out that we have one unit that provides both the brain application as well a spine application, with small hardware changes and software changes, but one unit, it became very attractive to that individual. And they kind of stopped in their tracks, are now going to look at our solution to see if it's something they might want to move forward with, so this idea of leveraging ROSA Brain and its percent penetration in the neuro area is a real opportunity for us. I truly believe that we have over 100 units placed around the globe, something like 140 units placed around the globe. It is the gold standard when you're talking about robotics inside of neuro. And again, the beautiful thing about this is it was actually designed, the ROSA system, for brain. And the intense accuracy you need for brain is now also applying to the accuracy that we're getting because it was designed for that for both spine as well as for knee. When you think about spine in particular, active tracking in a spine procedure is really important. You're placing a pedicle screw in a spine procedure. And for whatever reason, that robotic system somehow gets unregistered with the patient, you put that screw in places you don't want it to go. With active tracking, whether you move the patient, whether you move the robotic system, the robotic system always knows where the patient is and you're going to place the screw where you're supposed to place it. That's a big deal. When I talked to this guy about this at dinner the other night, he was surprised to hear about the two applications and one robotic system and loved this idea of active tracking. So, again, I think we can absolutely take advantage of the fact that we have a combined system between brain and spine, and that's obviously the intent of the organization is to do that.
Coleman Lannum:
Okay, Rich. We're going to try to get one more question in even though we're past the bottom of the hour. This will be the last one. Last question please.
Operator:
And our final question comes from Mike Matson with Needham & Company.
Michael Matson:
Hi. Thanks for squeezing me in. Looked like spine and CMF growth improved a little. Just wonder if you can comment on that. Is it spine? Is it CMF? Is it both? Thanks.
Bryan Hanson:
Yeah. Absolutely. If I look at that overall business, clearly, over the past few quarters, we've seen a little bit better strength. Strength is relative, obviously, given some of the performance previously, but certainly improvement. What I would tell you is that we still have work to do in the spine side of that group, still work-in-process is the way that I would define it. We're very enthusiastic about the new team, the new channel structure that we have in place. Some of the new technologies that we're going to be launching to differentiate ourselves would be spine, robotics, the ROSA robotics program and Walter which we have not talked a lot about today. But the combination of robotics in ROSA form and in the mini robotics in Walter, combined with our implants in devices, really does provide a unique solution for us. And we're excited about that. But the real driver of the growth that we've seen in that business has been CMF or craniomaxillofacial business. They've – just across the board. That team continues to execute. Very excited about what they're doing. But a big part of it, kind of the leading pieces in the cranial business is the ROSA Brain. I think people do forget that we have platforms across all three applications for robotics. And we are getting traction there. And the fact is, even though we have 140 units or so placed throughout the world, it's still significantly underpenetrated. And just to describe the benefit here, when you get a ROSA Brain procedure for an epileptic patient, you're going to place depth electrodes to find out where the seizure is happening in the brain. If you don't have a robotics system, if you don't have ROSA, that's a six-hour-plus procedure. It's extremely tedious. It's very complex. With ROSA, it takes it down to two hours or less. So, it is a dramatic change for patients and surgeons. That's why it's getting the adoption and we still have room to go. So, we're excited about that system. And as you previously referenced, it does give us a foothold in once we get a ROSA system in, the one ROSA unit to be able to leverage that to get spine in as well.
Coleman Lannum:
And thanks for that, Mike. And thanks for everyone. Like I say, we went a little bit over today because we had a lot of stuff we wanted to get out. I know it's been a long earnings week for all of you, so we appreciate your patience. So, thanks for joining us. Just a quick reminder, a replay of this call will be available later today. You can review it on our website at zimmerbiomet.com. And we'll be available to take questions. It will be a busy day. So, best way to reach us is via email. Have a great day. Have a great weekend. Thanks for participation. Bye-bye.
Operator:
Thank you again for participating in today's conference call. You may now disconnect.
Operator:
Good morning, ladies and gentlemen and welcome to the Zimmer Biomet Fourth Quarter 2018 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today, Friday, February 1, 2019. Following today's presentation there will be a question and answer session. At this time, all participants are in a listen-only mode. [Operator Instructions] I would now like to turn the conference over to Cole Lannum, Senior Vice President, Investor Relations and IRO. Please go ahead, sir.
Cole Lannum:
Thank you, operator, and good morning, everyone. Welcome to Zimmer Biomet’s fourth quarter and full year 2018 earnings conference call. I'm joined by Bryan Hanson, our President and CEO, and by our CFO, Dan Florin. Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. Now, actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please note that we assume no obligation to update these forward-looking statements, even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties in addition to the inherent limitations of such forward-looking statements. Also, the discussions on this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within the earnings release found on our website at zimmerbiomet.com. With that, I'll now turn over the call to Bryan. Bryan?
Bryan Hanson:
Thanks, Cole and thank you to everyone for joining us this morning. Today I'd like to provide a little color on our fourth quarter and full year results, as well as an overview of the progress we are making on our short-term priorities. Dan will then spend time talking about the financials in more detail and provide color around our 2019 expectations. Looking at the business from an operational perspective, we generated 1.6% revenue growth for the quarter. Overall, the team is encouraged that we closed the fourth quarter strong in several product categories and geographies. We delivered solid o-US results, driven by strength in our Asia Pacific and Europe, Middle East, and Africa regions. The quarter also benefited from improved growth in our global Spine & CMF business. When looking at the full year 2018, there are a few things I'd like to point out. First of all, our overall growth rate improved from 2017 to 2018, driven mainly by global large joint performance improved growth in both our Americas and EMEA regions and steady outperformance from our APAC region. And inside the year, revenue growth improved from the first half to the back half of the year. In fact, the last two quarters in 2018 were the best quarters we've had in global large joints in the last two years, which allowed us to reduce the gap to market in 2018. And obviously, although, none of us should get too excited about 1% growth, we are clearly making progress consistent with our turnaround timeline. Additionally, during 2018, we made significant progress across all of our communicated short-term priorities
Dan Florin:
Thank you, Bryan. I will provide highlights of the fourth quarter financial performance and then go into a bit more detail on the 2019 sales and earnings guidance included in our press release this morning. Net sales totaled $2.1 billion in the fourth quarter, an increase of 0.1% over the prior year period with an increase of 1.6% on a constant currency basis. As Bryan noted, we delivered solid results in both Asia Pacific and in our Europe, Middle East, and Africa region. Within the quarter, our EMEA region increased sales by 4.7%. Note that the EMEA region benefited from top line rebate adjustments. But even excluding these adjustments, the region still reported a growth rate of nearly 3% for the quarter, its best performance in almost two years. Our Asia Pacific region, delivered another strong quarter with sales growth of 7.2%; while our Americas region declined 0.9% reflecting tougher comparisons in the quarter. In addition, our Spine & CMF business increased sales by 3.1% on a constant currency basis, achieving its highest growth rate in the last three years. With regard to pricing in the quarter, we experienced an overall decline of 2%. However, when you adjust for the rebate benefit in our EMEA region, pricing was in line with our historical norms. Moving to the income statement. We reported a GAAP diluted loss per share for the quarter of $4.42. After adjusting for special items, our non-GAAP adjusted diluted earnings per share were $2.18. A reconciliation of reported earnings per share to adjusted net earnings per share is included in this morning's press release. Of note, we recorded a one-time non-cash charge of $4.78 per share related to goodwill impairment of our Spine and EMEA reporting segments. In addition, we recorded a non-cash accrual of $0.59 per share related to a negative development in a previously disclosed litigation matter. As usual, operating margin for the fourth quarter was seasonally strong at 29.3%. For the full year, operating margin came in at 27.9%, which was in line with our expectations. The adjusted effective tax rate for the quarter was 16.5%, which brings our full year adjusted effective tax rate to 18%. Operating cash flow for the quarter amounted to $380 million and our free cash flow was $260 million. For the year, operating cash flow was $1.7 billion and free cash flow was $1.3 billion. We paid down $250 million of debt in the fourth quarter bringing our full year debt paydown to just under $1.2 billion. During 2018, we reduced our adjusted net debt leverage ratio to 3.2. Now, let me turn to our 2019 guidance. In our press release this morning, we highlighted a number of specific items which should help you in your modeling. Starting with revenue, for 2019, we expect reported growth to be in a range of negative 0.5% to positive 0.5% which brackets the current consensus estimates. Included in our reported growth range is the negative impact of foreign exchange, which we expect will reduce reported sales between 100 and 150 basis points. Importantly, there are two factors that will impact quarterly revenue phasing; foreign currency and billing days. First, based upon today's rates, virtually all of the negative foreign exchange impact will be realized in the first half of the year weighted much more heavily in the first quarter as compared to the second quarter. In addition, while there is no significant impact from billing days for the full year, there is about a day of headwind in the first half of the year which is offset in the second half. On an operational basis, we expect our growth rate in 2019 to be better than our performance in 2018, reflecting progress toward achieving our two-year turnaround goals. Turning to profitability, we expect operating margin for the full year to be between 27% and 28%, reflecting the investments we are making to launch our new products. If you look across the quarters, the phasing of our reported sales will have a direct impact on operating margins and earnings. Therefore you should expect the first half operating margin to come in closer to the lower end of the range with the second half closer to the higher end of that range. We expect our adjusted tax rate to be between 17% and 18% and we expect adjusted diluted earnings per share to be between $7.70 and $7.90. For 2019, we expect to generate free cash flow between $1.1 billion and $1.3 billion. Note that this range includes the potential one-time payment of approximately $170 million for the litigation matter that I mentioned earlier. If you adjust for this potential one-time payment, we expect our free cash flow to be at or above the amount we generated in 2018. We expect to continue using the majority of our free cash flow to pay down debt and achieve our leverage goals. Finally, you should expect interest expense to come in between $230 million and $240 million with the quarterly number falling throughout the year as we continue to reduce our debt levels. And with that I'll turn the call back to Bryan. Bryan?
Bryan Hanson:
Okay. Thanks Dan. And before we move into Q&A, I just want to say that I'm very pleased with the progress we've made as a team. Our performance was better in 2018 than 2017 and we expect 2019 to be better than 2018. While we're halfway through the turnaround timeline, importantly, we have retired more than half the risk associated with that plan. Although, we still have a lot of work to do, we have a team that's ready to launch important new solutions for our customers and deliver on our near-term commitments to transition the organization to full offense and prepare for 2020 and beyond. And now I'd like to go ahead and turn the call back to Cole, so we can get started on the Q&A.
Cole Lannum:
Thanks, Bryan. Now, before we start the Q&A session, I want to remind you to please limit yourself to a single question with a brief follow-up, if and only if needed. Feel free to put yourself back in queue afterwards, and I promise we will get through as many questions as possible that way. With that operator, may we please have the first question?
Operator:
Thank you, sir. [Operator Instructions] We will take our first question from Joanne Wuensch with BMO Capital Markets. Please go ahead.
Joanne Wuensch:
Good morning. And thank you for taking the question. I think one of the things that we've been talking to investors about is how this AAOS will be different for you than last year or the year before that particularly with the launch of ROSA. Could you give us an idea of how you plan on launching ROSA into the market and what we can expect this year?
Operator:
Ladies and gentlemen, one moment while we check for technical difficulties. And Mr. Lannum, you are live.
Cole Lannum:
Hi, everybody. Well, that was interesting. Sorry for that. Right now we were closing up. Our line went dead, but now we're back with you again. Thanks for your patience. Operator I believe you queued up the first question. Did you say that was coming from Joanne?
Operator:
Joanne Wuensch with BMO Capital Markets.
Coleman Lannum:
Joanne. Thanks everyone for your patience. Joanne, please go right ahead. We're all here.
Joanne Wuensch:
Thank you. The question was just so good that I broke the system. Anyway, this year's AAOS is positioned to be very different for you than last year or the last couple of years. And a lot of investors are focused on the launch of ROSA and how you plan to roll it out not just in March, but throughout the rest of this year. Could you give us an idea of what to expect at AAOS and what to expect from ROSA?
Bryan Hanson:
Yes, Joanne. Thanks for the question. The – I don't think it was you. I think it was Cole pressed and hung up on us. But AAOS will be very different for us coming up and one of the things that we're going to be doing differently at the conference is to have an investor meeting. I think its a couple hours, Cole, what we’re thinking about. And the idea behind that would be to give a view of both our spine as well as the orthopedic businesses. We'll have both of our Group Presidents that manage those businesses at the event. It will give you an opportunity to get to know them in the investor meeting, and we'll have breakout sessions where we'll get into some of the more meaningful technologies that we'll be launching in 2019 or have already launched. ROSA, obviously, will be one of those things that we talk about, very likely both in orthopedics as well as spine and probably even at least reference to some extent what we're doing in brain. But it would not be the only thing. So again we expect it to be a much different feel, AAOS this year. And certainly we want to make sure that we spend additional time with our investors to give them visibility to our team and probably very importantly for everyone more insight into the innovations that we have.
Cole Lannum:
And Joanne since you brought that up, let me also note and put a plug into this. We've sent the invitation out. Anyone who's on the call who has not got the invitation send me an e-mail and let me know. And it is very important that everyone preregister because we've already gotten a pretty overwhelming response to that meeting. We want to make sure there's enough room for everyone. So please if you're planning on coming, let us know. And thanks for the question. Operator, next question please.
Operator:
We will take our next question from Mike Matson with Needham & Company.
Mike Matson:
Hi, good morning. Thanks for taking my question. I guess, I would just like to follow-up on Joanne's question about the actual robot launch. I understand you're going to have some investor events there. But can you just talk about how you're actually going to launch it? Are you going to be willing to place robots in exchange for increased implant sales? Are you building a capital sales force? And how should we think about the impact on your growth in 2019 and 2020? Thanks.
Bryan Hanson:
Yeah, absolutely. I'm not going to get into specifics relative to our placement strategy whether it be associated with ASP, the types of arrangements we might have outside of just direct sale. But just know that one of the primary focus points of robotics for us is to be able to drive share obviously. So we're an implant company that will be the primary focus of the organization. But clearly we believe robotics is an important factor associated with being able to more share implants. What I would say is we're going to -- as we've been saying pretty much all along, we're going to do a limited launch out of the gate. We want to be very disciplined in our approach to launching a new robotic system to make sure that we do it right. We have the right education. We have the right service levels. And we will do that limited launch for let's call it six months. Post that limited launch is when we move into full launch. And that's when the organization gets unleashed and we utilize that technology in that full launch status. And in the guidance that we provided for 2019 that is already assumed inside the guidance. So I guess just generally speaking though, I'm excited. One of our competitors presented just recently here and talked about the continued strength in robotics. That's perfect. I love to hear it because we're just about to launch our robotic platform in a market that is surging. And when you think about it and the under-penetration of robotics in general, when you think about the number of surgeons that are doing procedures today with our implants, there's very good opportunity for us and we couldn't be more excited about the fact that robotics is getting good traction. And we're excited about our launch.
Mike Matson:
Thank you.
Cole Lannum:
Operator next -- okay, thank you. Next question please.
Operator:
Our next question is from Raj Denhoy with Jefferies.
Raj Denhoy:
Hi, good morning. Maybe Dan I could ask about the gross margin in the quarter. It was a little bit better. And I know there's some seasonality there, but when you think about the comments you've made now about moving beyond being supply constrained and the quality issues starting to fade, maybe you could offer some guidance or some insight into how gross margin should trend here in 2019.
Dan Florin:
Sure Raj. Well, as we said in our prepared remarks and you just referenced, Q4 is typically our highest operating margin quarter due to the seasonally strong sales volume. And that seasonally strong sales volume also benefits gross margin rate. And if you look just back over history, you'll see not only operating margin, but gross margin rates for the company being usually the strongest in the fourth quarter. And really the primary reason for that is that we're able to leverage certain fixed cost components that are inside of the cost of goods line, all right? So, that's why it's probably better to look at gross margin for Zimmer Biomet on a full year basis which for 2018 was 72%. So, as we look out to 2019 and contemplated in our guidance, our guidance of operating margin 27% to 28%, while we're not going to get specific line item detail inside the 27% to 28%. As we've been saying, you shouldn't expect margin expansion until 2020. And really when you think about gross margin and operating margin in 2019, the reasons for that include the continued higher production costs that we've been talking quite a bit about, but also the investments that we're making in our sales channel and the investments that we're making to support the new product launches that we're very excited about. So, again, I think for 2019, as we've been describing, no operating margin growth. You'll see that in 2020 and our guidance contemplates that.
Raj Denhoy:
Great. So…
Cole Lannum:
Yes, go ahead.
Raj Denhoy:
No, I was just going to ask. So, we should assume that both gross margin and operating margin should be flat in a sense. So gross margin could potentially tick-up as you noted with better sales. But you'll probably be spending a bit more in SG&A, I guess, to keep that gross -- excuse me -- to keep the operating margin flat. Is that the way to think about it?
Dan Florin:
Well, I mean the guidance provide the range. And inside of that there's obviously moving parts through the P&L. But I think that the message we're sending is that 2019 is a year of continued investment and topline acceleration in the back half and margin expansion is more of a 2020 story and beyond.
Raj Denhoy:
Okay, great. Thank you.
Cole Lannum:
Thanks Raj. Next question please.
Operator:
Our next question is from Bob Hopkins with Bank of America.
Cole Lannum:
Good morning Bob.
Bryan Hanson:
Maybe there's a technical difficulty.
Cole Lannum:
Yes, Bob, are you on the same line that we're on? Are you there? Okay, operator, could you go to the next question please and if Bob…
Bob Hopkins:
No, sorry, I'm here. I apologize. Can you hear me okay?
Cole Lannum:
No problem. Yes, we can hear you Bob. Go ahead.
Bob Hopkins:
So, super. I just wanted to ask one quick question and I'm going to keep it high level this time. I wanted to ask a question Bryan on U.S. knee market share. Because as trying to gauge the stability of your knee franchise and as outsiders, all we can really look at is, kind of, relative revenue growth rates in knee. So, it's hard for us to understand sort of volume share given that mix can have such a big impact on revenue growth. So, my question is this, kind of, what do you think the Zimmer U.S. market share is in knees exiting 2018? And how does that compare to where you were a year ago? And again, the reason I'm asking the question, I'm trying to get a real sense as to sort of the true stability of your knee franchise over the course of 2018 in the U.S. where I assume you have the best data. Thank you very much.
Bryan Hanson:
Okay. I appreciate the question, Bob. So I've been thinking a lot about this as well. I'm just going to try to paraphrase what it is you're asking. But I think what you're looking for is, if you look at share you can either look at it from a dollar perspective or you could look at it from a unit or procedure perspective. And what I would say is that, either way if you look at where we are in 2018, whether you look at it for procedures or units or you look at it in dollars, we have closed the gap to market. It doesn't matter which way you look at it, we have definitely closed the gap to market. But inside of that, I believe that our unit gap or procedure gap is actually lower than the dollar gap and always has been. And let me just kind of explain why I'm saying that, because I've been spending a lot of time on this, so it's a good question actually. Really, three reasons or kind of factors for share loss for the company that I see. The first one is kind of the obvious, right? I mean, you lose a surgeon to the competition. This is something that would impact both unit share as well as dollar share. It may not be exactly, because the price points might be slightly different, but they impact of both. The other one would be, losing our patients to the competition's surgeon. And what I mean by that, if a surgeon's doing -- if a patient's doing an elective procedure and they decide to do research on where they're going to get that procedure done. And they decide they want to go to a robotic surgeon that's no longer a patient that's going to my surgeon it’s going to be somebody else's surgeon. That also impacts both unit and dollar share. The third one is this idea of competitors that are increasing their revenues due to mix. Whereas in the same procedure they had with the same surgeon, they're just increasing the share of wallet they're getting in that procedure. Those are all three things that are happening. I really do believe we are losing surgeons and we're not winning the churn game right now. I do believe we're losing patients to our competitors' surgeon. But I think by far, the biggest contributor to share loss is third category, that our competitors are doing a very good job of going right to the surgeons they have in the procedures they already have and upsell in robotics in cementless and other areas. And so, for that reason, I actually think that the unit share loss that we've had is not as substantial as the dollar share loss. And the reason why I think it's important and I think it's kind of -- probably it's getting to your question, the fact is one of the biggest contributors to mix benefit inside of the space that we play is robotics. And you got robotic surging right now and here we come with our robotics platform. And let's not forget that when you look at the largest number of surgeries being done today in knees, it's our implants. It's our surgeons doing those procedures. And we're about to provide them an opportunity to have access to robotics in that largest segment of knees globally. So that's pretty exciting. Don't get me wrong here. We're going to go after every single one of these areas to be able close our gap to market and begin to get back to market or above. We're going to try to convert competitive surgeons. We're going to market directly to patients with a personalized robotic approach, using our mymobility app backed by Apple, which has very strong consumer demand. But I think our biggest opportunity to close the gap is to be able to get the mix benefit in the procedures we already have with the surgeons that we already have. So we're pretty excited about it obviously.
Cole Lannum:
Thanks, Bob. Thanks for the succinctness of the question. Could we have the next question, please? Next question operator, please.
Operator:
Our next question is from Kyle Rose with Canaccord.
Kyle Rose:
Great. Thank you very much for taking the questions. Can you hear me all right?
Bryan Hanson:
Yes.
Kyle Rose:
So Bryan for the last 12 months and including this morning, you noted the importance of regaining the trust of both the sales force and the physician customers to really be able to go back on the offensive. Can you talk to us and just kind of give us an update on where both of those stand exiting 2018 moving into 2019? And what specifically needs to happen over the course of 2019 to get you to the position where you want to be exiting the year to get to 2% to 3% topline growth in 2020? Is it as simple as just hitting launch and your product availability, milestones or are there other things that need to happen across the course of the year?
Bryan Hanson:
Probably just depending on which constituent you're talking about. But if you talk about surgeons, I think it's exactly what you just said. We've got to be able to continue to provide the product when they need it and what they want. And we need to bring these new product launches to market in a flawless manner. And my belief is, with the supply coming in, in the way it is with the new product launches that we have coming, I have a lot of confidence that our surgeons will build confidence in our organization throughout 2019. So that to me is as soon as we are supposed to do which I fully expect we will, our sense is we're going to see increased confidence from our surgeons and we're going to delight them in 2019. From a internal team member perspective, I think there's more that goes into it. Obviously having supply is first step. No question. You got to make sure that we can deliver what our commercial organization needs, but also it's the support that.[Technical Difficulty]...
Operator:
Ladies and gentlemen please standby. Mr. Lannum you are live.
Cole Lannum:
Hi, thanks again everyone. We're certainly going to have to talk to our AT&T folks after this and we apologize for the continued snafus. Let's go back. Bryan you were responding to the question.
Bryan Hanson:
Yes. I don't know for sure where I dropped off. But I think I was talking about how we get the trust and confidence of our team members at this point. And what I was saying is, it goes beyond just supply. Obviously that's a foregone conclusion. New products will absolutely contribute to the feeling that they have and the confidence they have in the organization. But the big one is to make sure that the leaders of the organization including myself; Ivan Tornos who now runs the orthopedics business is directly engaged with that commercial organization. So they know the leadership is behind them. The leadership understands the value they bring to the table and that nothing happens until they sell something. So we'll be the support that they're looking for. The compensation scheme is in place to make sure that we're driving offense versus defense. The other thing that I would say is, we just have all of our kickoff meetings. I was able to attend some of them. Obviously I was at the Americas kickoff meeting which is our largest. And the energy that I felt in those meetings was better than I've ever felt. And I'm not talking about this environment in any meeting I've ever been in. It was definitely a situation, where the team was there. We had bigger presence than we've ever had at that meeting around the world, and people are walking out the door excited about 2019. Now they've got to deliver but the energy coming out of that meeting gives me the confidence that the organization's moving in the right direction relative to trust.
Cole Lannum:
So, Kyle hopefully you heard between the first part and the second part enough of that complete answer and again, everyone, thanks for your patience. Operator, next question please.
Operator:
Our next question is from Richard Newitter with the SVB Leerink.
Richard Newitter:
Thanks for taking the questions. Just to focus a little bit on the international strength we've been seeing here for a couple of quarters. My question is, how sustainable is this? And as you answer that, can you maybe talk about some of the headwinds and tailwinds we should be considering that you face in APAC and EMEA? Thanks.
Bryan Hanson:
Yeah. Yeah. So first of all, I would be completely remiss, if I didn't congratulate both regions. APAC just continues to be a force and overachieve versus market and they did not disappoint us again in Q4. And it's just been a phenomenal year for that team and we fully expect that they'll continue to perform well coming into 2019. So, just congratulations to that team once again. In EMEA, it hasn't been as strong this year, but the fourth quarter was fantastic. And I got to tell you, I really want to call that team out, because in the face of leadership changes that are pretty material the whole – the actual leader of the region has changed, and we've changed the structure of the team. And in the face of that, which could have been disruptive, they delivered their best quarter in the last two years. So they're clearly benefited from the rebate adjustment when you look at the whole number that Dan talked about in the prepared remarks. But the fact is, it was still even outside of that, the best growth rate they've had in some time. So I'm happy about the performance. What I would tell you, is if I look at EMEA specifically, I would fully expect when you look at the full year 2018 for their performance to be better in 2019. I'm not necessarily saying it's going to look exactly like the fourth quarter. But when you look at the full year, I would fully expect them to be better in 2019. And so for Asia-Pacific, again, I think we're going to continue to see strength. And with EMEA, I think we're going to see improvement 2018 to 2019.
Richard Newitter:
Thanks.
Cole Lannum:
Thanks, Richard. Next question, please.
Operator:
Our next question is from Glenn Novarro from RBC Capital Markets.
Glenn Novarro:
Hi. Good morning. Thanks for taking my question. You guys highlighted your debt leverage at 3.2 times. And my question is that, a number that you feel comfortable with to start diving back and start doing acquisitions? And the reason I'm asking is your goal is to get to 2% to 3% market growth by next year. But I know you don't want to stop there. I know, you want to be above that in the years thereafter. So talk about, where the leverage is and talk about how important M&A is to getting to higher growth rates and the timing as to when we could start seeing M&A? Thank you.
Bryan Hanson:
So, Glenn, why don't I take a shot just at the top line kind of answer to this and then Dan I'll pass over to you with more specifics on the debt leverage. What I'd tell you is that clearly our goal on the debt ratio is to be lower than what we are right now. And as Dan mentioned, we're going to continue to use a lot of our cash to be able to buy down that debt. At the same time, if there are targets that are attracted to us and make financial sense and strategic sense to the organization and we think it provides good shareholder returns that we would certainly look at those targets today. If I have everything done perfectly and sequentially as I would like, my preference would be to wait to the back half of 2019 to really start to do any type of real BD&L, because BD&L as much as it is beneficial, it can absolutely be distracting. And I want the organization to stay maniacally focused on the short-term objectives that we've laid out between 2018 and 2019. So, if I can lay it out perfectly, I want to start moving more into active BD&L towards the back half of 2019 or 2020 and stay very focused our short-term objectives until then. But I -- just so we don't surprise anybody, if an opportunity ever came about, if something came out opportunistically in a period shorter than that and we thought it made sense, we would certainly take a look at it. But Dan why don't you...
Dan Florin:
Sure. I would just add Glenn that when you think about our financial flexibility and what we're trying to accomplish on the leverage side, it fits perfectly with the timing that Bryan just described. In other words, we're entering 2019 at 3.2 times. Goal has been to make progress beyond that net leverage in that three times type range or better. And I think that based on our guidance that we provided, the free cash flow that we'll generate in 2019, we said the majority of that will go towards that paydown. I think that fits perfectly with what Bryan just described on the strategic front and the BD&L side of things. So, we're excited about the ability to as we enter 2020 to have financial flexibility and firepower to do the things -- to supplement the organic growth of Zimmer Biomet.
Glenn Novarro:
Okay, great. Thank you.
Cole Lannum:
Thank you for the question Glenn. Next question please.
Operator:
Our next question is from Matt Miksic with Credit Suisse.
Matt Miksic:
Hi, good morning. Thanks for taking the question. So, I'll focus if I could just on Bryan your comments on growth and the gap to market -- closing the gap to market, which I take to mean the degree to which you're growing below market, kind of, narrowing that growth gap if I understand it correctly. So, if the U.S. market is growing maybe 2%, the U.S. knee market, say, and your Americas knee growth is down 1.5% to 2%. My question is now that supply issues are kind of behind you as you talked about in your prepared remarks no longer a challenge to growth, when should we expect to see you sort of get to that market or exceed that market growth rate over the next several quarters? And how does that work?
Bryan Hanson:
Yes. So, the way you're reading my description of our gap to market is accurate. Unfortunately, it's not talking about the gap above market; it's talking about the gap closing below market. But the way we've been describing it is that this two-year kind of reshaping and positioning for offense is to allow us in 2020 in a durable manner to be able to get to market. That's the weighted average market growth that we've been describing in that kind of 2% to 3% in 2020. So, if you kind of just read into that knee being a very large portion of our business that would indicate that our expectation would be that we would continue to see share unfortunately in 2019. But in 2020, that would no longer be the case. And the thing that gives us confidence in that is that we got innovation coming that we have not had in a long time. And most of that gets into full swing and full launch in the back half of 2019 which gives our organization, that commercial channel that we were just talking about, the opportunity now to go on full offense.
Matt Miksic:
Just to clarify, I guess, if I could. So, the supply -- the return to supply is sort of a component, but not sufficient in your view to start rolling that back -- start rolling those share losses back. It will be the products. It will be the ROSA launch. All of these things together kind of maybe in the back half. Is that -- am I hearing that right?
Bryan Hanson:
100% read that. If you think about the comment that I made when -- it was Bob's question I believe. Bob's question on unit versus dollar market share, one of the biggest contributors to revenue growth right now in our space is increasing the mix, right? So in other words, you getting a higher share of wallet inside a procedure you already have. That comes through new technology, not just flat recovery. It comes by keeping the surgeons you have, obviously, being able to supply them but being able to upsell because of better technology and get more share of wallet through those procedures. That doesn't really happen for us in full swing until we get into the back half of 2019. So it is an extremely important component for us to get back to market or potentially exceed market.
Dan Florin:
And certainly the full launch of cement -- Persona cementless, which is happening now; and then Persona Revision in the back half of the year both at premium price will contribute towards that.
Bryan Hanson:
Yes, I agree.
Matt Miksic:
Okay, great. Thank you.
Cole Lannum:
Thanks for the question Matt. Next question please.
Operator:
Our next question is from David Lewis with Morgan Stanley.
David Lewis:
Good morning. Bryan, just one for me and maybe I'll shift focus to spine. So this is an area where you had a fair amount of enthusiasm last year. It was mostly targeted on your confidence sort of the spine integration and distributor transition that was ongoing. Obviously it was better quarter here in the fore. So two related questions are, one, how confident are you feeling in that and continue to improve in the spine business in 2019? And there's been a lot of commentary robotics and knee on this call, but obviously the debate in spine for 2019 will be robotics and spine. Where are you with spine robotics? And how important is that as a factor here in 2019? Thank you.
Bryan Hanson:
Yeah, yeah, thanks. So real quick, just on the spine piece on ROSA. We are waiting for FDA approval on that. And I don't want to give a specific time line, but it would be great to have that before AAOS. There's a possibility of that. But we do think that sometime in the second quarter we will have it. The hope is we get it before and we can talk a little bit more about it AAOS. So that just gives you a little sense of where we are with spine, but we have submitted the approval or the request. I also want to call out I mean this is the best quarter. I think Dan said it in his prepared remarks that it's best quarter we've had in a few years in this combined business. And it's a testament to the team getting the job done. I also want to make sure that it's clear that it was both businesses that had a better quarter. Spine continues overall to be negative for us, and I don’t know if we've ever called that out. But it is negative for us overall, but it improved. So we've talked about that gap to market before, the gap to market reduced, but it's still a negative number. But it did improve, which is a big part of that improvement in the fourth quarter. And then the CMF business continues to show strength and had a really strong close to 2018. And a portion of that, which we haven’t really been talking much about was our sales in ROSA, Brain. So remember it's not just ROSA Knee application, it's not just the spine application, we also have an application in brain and we had pretty good sales in the fourth quarter. And that helped the number as well. So overall congratulations to the team. Best quarter in a while. And I feel like we've got the right leadership, we've got the right structure in place. And we've got a nice product portfolio that's coming in 2019. So, when I look at that total business, I'll be very surprised if we don't do better in 2019 than we did in 2018.
Cole Lannum:
Thanks for the question, David. Next question operator please.
Operator:
Our next question is from Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
Good morning. Thanks for taking the question. I wanted to focus on ROSA for total knee since that's such an important product for you guys. So my question is Bryan or Dan around how de-risked do you think the full launch in six months? How broad is the limited launch going to be? Are you confident you've kind of worked out the major kinks? And if you could give us any color on how many implants have been done so far and what you think the unique features and benefits are of the system that would be helpful? Thank you for taking the question.
Bryan Hanson:
Yes. So I don't want to get too much into the unique feature set associated with ROSA. We've talked a lot about it probably even more than I would like to be honest. Because in reality anything we're seeing here, it goes right to our competition. Until we are actually getting more in the full swing of the launch, why would we do that? I will tell you that, you're going to get much more insight on what we believe the value is of ROSA for our surgeons, which is the most important constituent that we have. And you're going to see that at AAOS. What I would -- just say generally speaking is, I think we have a very competitive robotic system. One of the key things that we try to focus on is to be able to get high-volume surgeons to be able to use robotics. Remember, when we talk about the play here, there's an opportunity for share of wallet gain in every robotic case. Every robotic case provides an opportunity for better mix. So the better throughput we can get on our robotic system, the better off we are as an organization to take advantage of that mix. And high-volume surgeons just historically...[Technical Difficulty]
Operator:
Ladies and gentlemen please standby. Mr. Lannum you are live.
Cole Lannum:
Okay. Third time's a charm and sorry about that again. We're going to continue where we left off.
Bryan Hanson:
So this is reminiscent of our supply problems in 2016 and 2017. No longer our supply problems going forward. But I think I was just getting into thing around high-volume surgeons. High-volume surgeons typically had stayed away from robotics because it slows them down and they can't keep the volume of patients that they'd like to have. Our goal is to eliminate that, to be able to get all the accuracy that we get with robotics, but not change the flow of the procedure in a way that would reduce the throughput they could get on patients. That's a big deal because high-volume surgeons is who we want because you get mix benefit for every procedure. So just, that will be all, I'd say about the differences of us versus the competition. You'll see more AAOS. I feel like we're in pretty good shape relative to confidence in being able to roll this out effectively. Remember, we're not new to robotics. We have the brain robotic system that's been out in the market. We have over 100 units out in the world today. We understand the service associated with these units. We understand the education that's required and we have expertise in the organization that is not new to robotics. So that gives me a lot more confidence than if we were organization launching our first robotic system.
Larry Biegelsen:
Thank you.
Cole Lannum:
Thank you, Larry. Next question, please.
Operator:
Our next question is from Isaac Ro with Goldman Sachs.
Isaac Ro:
Good morning, guys. Thank you. Wanted to ask a question related to the guidance specifically with regards to spending that you're doing on the supply and quality remediation work. Just curious, what's baked into the guidance? I think you guys have called for flat margins more or less. And I'm wondering within that, if the spending on quality supply remediation is going to be flat up or down and in what area? Just any context there to help us think through what's going on under the hood would be great? Thank you.
Dan Florin:
Sure, Isaac. Well, first let's talk about within the adjusted earnings per share guidance, which was $7.70 to $7.90. What I was describing before, the operating margin of 27% to 28%, inside of that operating margin continues to assume pressure at the cost line, as we've been describing. So meet those elevated production costs, the capitalization of those costs and to expect that pressure to continue through 2019 with improvement coming in 2020. So that's on the adjusted P&L side of the house. Within our cash specials is where we've been capturing the pure remediation costs for quality remediation. And as we continue to progress on that program as we prepare for a FDA inspection by the end of 2019 that quality spending – that quality remediation spending will be ramping down as we progress through 2019. So in our free cash flow that does contemplate a reduction and a ramp-down in quality remediation spending, which I think is a good setup for 2020 in terms of again cash specials continuing to ramp down. Also, within the free cash flow is investment in new product launches. So the instrumentation, the inventory associated with all the new products that's all contemplated inside our free cash flow range as possible as well. So, again, just to reiterate within the adjusted P&L, continued pressure of the gross margin line for the reasons we've discussed. And then on the cash flow guidance, an expectation that quality spend will be ramping down.
Isaac Ro:
Got it. Thank you.
Cole Lannum:
Thank you, Isaac. Next question, please.
Operator:
Our next question is from Amit Hazan with Citigroup.
Amit Hazan:
Thanks very much and good morning. I want to come back to guidance for a second and just set-up the top line as a question for you and try to gauge, if this is indicative of increased confidence or if I'm reading too much into it. But if I kind of take the upper end of your ex-FX guidance, you obviously get to about 2% growth so you're into that 2% to 3% weighted average market growth. And we talked before in the past – recent past about bone cement being an impact of 50 to 75 basis points. And so that gets you well into kind of the mid-range of your weighted average market growth. So that seems to be an increased confidence versus what you guys were talking about in the last few months of 2018. Just help me out in thinking about that and whether that's the case or whether I'm reading too much into it?
Dan Florin:
I think one thing – one thing I will mention to you Amit is, what you're doing there is you're taking the very high-end of our ranges, and that's fair. I mean, that's within the range. But your assumptions would be that everything goes, right and push us to the high-end of the range, that's certainly a possibility. But I think in order to do that you need to also understand that range is a range and there are things that could push us to lower in that realm as well.
Bryan Hanson:
Yeah. But I think the – when you look at the performance in the back half, when you look at all the things we're stating relative to the innovation pipeline that we have not had in a while as an organization, and you look at some of the momentum, we're getting relative to the way the field is reacting to what they're seeing. It does give us confidence. I mean, fact is we're halfway through the two-year timeframe that we referenced, but as I said in my prepared remarks, I truly do believe we retired more than half the risk. It doesn't mean there aren't still challenges ahead of us. It doesn't mean that there's not a lot of things we still need to do. But the fact is we're feeling as bullish as we have. But we've given you a range for a reason. As Cole said, there are things that we think can help us get to the top end of that range, but there are also things that we need to manage through as we roll out the year to ensure that we don't move to the bottom end of that range. So, we've really spent a lot of time trying to give you a balanced view of what we think we can do in 2019. So, I hope you're reading into this more confidence as I'm feeling it. But the range is still reflective of that confidence.
Cole Lannum:
Hope that helps Amit. Next question please.
Operator:
Our next question is from Rick Wise with Stifel.
Rick Wise:
Good morning Bryan, hi Cole. Is product portfolio optimization a priority for you Bryan? Maybe it's a question for you and Dan. When I think about optimizing the business and typically in turnaround many times redundant product lines, older product lines are involved in the turnaround, SKU reductions phasing out the older products, making room for the newer ones, all of which I assume would benefit over time throughput margins, working capital, cash flows, et cetera. How are you thinking about that? And where are you in that kind of a process? And just what impact would that kind of a process have on growth, outlook, execution, et cetera? Thank you.
Bryan Hanson:
Yes. You're right on. I mean it is an important part of what we need to do as an organization. They're in for a number of reasons. But if I just think about supply and I think about quality just thinking about those vectors by themselves. As we begin to rationalize over time the portfolio, we clearly have an opportunity to increase our service levels from a supply perspective. The fewer categories we have, the better supply guarantee we're going to be able to provide, and the better service levels we're going to have. From a quality perspective, as you start to reduce SKUs, obviously, you have less risk in holds, in recalls, in process of getting ready to approvals. So, all those things benefit the organization and guarantee when we talk about moving from just supply stability to truly getting into supply efficiency this is on the radar. I don't want to scare anybody though at the same time because whenever I talk about this, everybody gets scared that we're going to do this and we're going to risk topline. That is not going to happen. Topline is the primary focus of the organization, but over time, we have got to be more disciplined relative to the portfolio optimization that we have. The other thing that's going to drive us in this direction is we will be a more focused organization. There's no more shotgun. It will be a rifle approach this year. We need to make sure that we look at the very specific areas that could drive mix benefit in our business and make sure that the organization collectively is focused in those areas. That gives us an opportunity to clearly start driving momentum in those specific areas. It gives us an opportunity to get better signals to the operations team so that we have better demand planning and ultimately directs traffic in specific areas, so we get better results. So, for all those reasons that I see us moving more in this direction, I just don't want anyone to be concerned that we're going to move too aggressively here and risk the topline.
Rick Wise:
Thank you.
Cole Lannum:
Thank you, Rick. Look, folks we're coming up on the bottom of the hour and I want to -- we need to wrap it up pretty soon. But I know we had a couple of lates here. Operator, let's try to see if we could sneak two more questions in and then we'll wrap it up. Next question please.
Operator:
Our next question is from Bruce Nudell with SunTrust.
Bruce Nudell:
Good morning. Thanks for taking the question. Bryan, I just want to talk about the mix benefits associated with the robot and assure that I'm thinking about this right. So just in the context of about a $5,000 implant you have $250 to $500 of robotic disposables. Going forward past that, you've got added value both in terms of planning and robotic technician support which helps stabilize the price. And then going forward beyond that, you have robots facilitating higher-end products like cementless knees and ultimately, bicruciate. So am I thinking about that right? And then also might the robot, when it's broadly used across the industry might we see real stabilization in knee pricing?
Bryan Hanson:
I'm not going to -- so I wouldn’t verify the specific elements relative to the disposable value or anything like that. But all the elements that you just referenced are exactly in line with the way we're thinking about mix inside of robotics. And my guess is, anybody else in robotics is thinking about it the same way. Another factor associated with this beyond just mix that I don't want to lose, because I do believe that we have an advantage is when we talk about Persona which is personalized medicine. It is personalizing the knee and anatomically speaking and size-wise for the patient. We start talking about personalized robotics with digital platforms that have the consumer appeal of Apple that is a pretty unique solution that we can begin to communicate to patients who do their homework on these procedures and potentially begin to deal in some of those patients to our surgeons. That will definitely be an area that we concentrate on. So it's not just robotics, not just mix. We clearly want to take advantage of that because we think there's a real opportunity and the elements that you referenced are exactly right. But we don't want to lose the other either.
Bruce Nudell:
Thanks so much.
Cole Lannum:
Sure, absolutely. Thanks. And let's do one last question, operator, and then we need to wrap up after that. Next question, please.
Operator:
Our last question will be from Kristen Stewart with Barclays.
Kristen Stewart:
Hi, everybody. Thanks for taking my call. Bryan, I know I kind of touched on this last quarter, but I wanted to get your updated thoughts. Just, as you're thinking about the longer-term kind of earnings power of this company, how should we think about how you're framing this? It sounds like from the guidance, the second half from an operating margin perspective will be towards the upper end of the range. It sounds like gross margins could be in a position to start to maybe expand again in 2020. Not to kind of get too far ahead, but how should investors just kind of think about what type power this company has today, absent any M&A?
Bryan Hanson:
Yes. So, -- I think it's a great question. So, first of all, you're thinking about it exactly right. We communicated pretty clearly; we don't expect margin expansion in 2019. I think the range indicates that. We've been saying that all along, but we would expect to start to see movement in that direction in 2020. And very clearly as we say that the three pillars of the organization, one of those pillars is going to be top-quartile performance for total shareholder return that would indicate that we clearly believe, not just topline, but also margin expansion and increasing cash flow are all things that this organization is capable of doing. Because there's no way that we can have that as a primary pillar of the organization if we didn't think in each of those categories we can improve. And I do believe that the stabilization that we've been talking about just in the businesses that we play in today is very real the target that we should have in 2020. But when I think about the mix benefits of some of these categories, if things go well, we can get deeper penetrations and things like robotics or cementless or see the stemless which all have premiums in those procedures, then there is that opportunity even without acquisitions to outperform the market. Now, my feeling is going forward, we want to do both if we want to durably be a contender for top-quartile performer in total shareholder returns. But don't think that today given the portfolio, if things go right, we wouldn't have a chance of outperforming market.
Kristen Stewart:
Thank you.
Cole Lannum:
Thanks for that Kristen. Thank you, Kristen. With that, we're going to close it down. Just as a couple of quick notes before we wrap-up. First of all, the sign of a good team is someone who can react quickly when something unexpected goes along. So, hopefully we were able to come back and still work through and answer most of your questions. If for some reason, and again, I apologize for the technical snafus, that was not the case, please do come back to me and -- so we make sure we could help you understand what's going on. As a reminder, a replay of this call is going to be available later today. You can review it on our website zimmerbiomet.com. And have a great Friday and a great weekend everyone. Bye, bye.
Operator:
Ladies and gentlemen, thank you again for participating in today's conference call. You may now disconnect.
Executives:
Cole Lannum - Investor Relations Bryan Hanson - President and Chief Executive Officer Dan Florin - Chief Financial Officer
Analysts:
Amit Hazan - Citigroup Bob Hopkins - Bank of America Josh Jennings - Cowen & Company Rick Wise - Stifel David Lewis - Morgan Stanley Isaac Ro - Goldman Sachs Robbie Marcus - JPMorgan Craig Bijou - Cantor Fitzgerald Steven Lichtman - Oppenheimer Larry Biegelsen - Wells Fargo Glenn Novarro - RBC Capital Markets Larry Keusch - Raymond James Kristen Stewart - Barclays Richard Newitter - Leerink Partners Matthew O'Brien - Piper Jaffray Vijay Kumar - Evercore ISI Stan Fediuk - SunTrust Chris Pasquale - Guggenheim
Operator:
Good morning, ladies and gentlemen and welcome to the Zimmer Biomet Third Quarter 2018 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today, October 26, 2018. [Operator Instructions] I would now like to turn the conference over to Cole Lannum, Senior Vice President, Investor Relations and IRO. Please go ahead, sir.
Cole Lannum:
Thank you and good morning. Welcome to Zimmer Biomet’s third quarter earnings conference call. I am joined by our President and CEO, Bryan Hanson and our CFO, Dan Florin. Before we get started, I would like to remind you that our comments during this call will include some forward-looking statements and of course actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please note that we assume no obligation to update these forward-looking statements even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties in addition to the inherent limitations of such forward-looking statements. Also the discussions on this call will include certain non-GAAP financial measures. The reconciliation of these measures to the most directly comparable GAAP financial measures is included within the earnings release found on our website at zimmerbiomet.com and we urge you to take a look at those. With that, I will now turn the call over to Bryan. Bryan?
Bryan Hanson:
Thanks, Cole and I just want to say thanks again for everyone joining us this morning. Overall, we feel pretty good about Q3. We delivered constant currency revenue of 2.3% and I can tell you pretty much across the board when I talked to our team members. We are all encouraged by the progress we are making in a number of areas and I will get into those in a second. But before I do that with the idea of being fully transparent on the quarter our results actually look a little better than they actually are for a couple reasons. First of all and I think this is probably pretty clear to everyone, we had a pretty easy third quarter comp, which buoyed revenue growth in the quarter obviously and unfortunately that will not continue in the fourth quarter. We have a much more challenging comp in the fourth quarter. In addition to that, we experienced notable timing benefits in the quarter with regard to both tenders and capital sales on the tender front that happened both in Asia-Pacific for us as well as EMEA and on the capital side it was mainly in our S.E.T. business, either way that those buoyed the third quarter results and will come as a result of that with some pressure to the fourth quarter. Good news is we have banked the revenue, which is the most important thing. So even though you are going to move those between quarters, I would much rather have the sale. So as much as we are happy with the third quarter, I believe it’s important to highlight these factors, because I think very importantly, I don’t want my team or you to get too excited that we appear to be at a weighted average market growth for the business. While we are pleased with the progress we are making, we clearly are not declaring victory and until we sustainably deliver that performance, we won’t. And I still firmly believe this should be a 2020 expectation. So, I guess the overall takeaway should be that our recovery timeline remains on track, but we are going to see some atypical quarterly timing and revenue facing here in the back half. So, my net message is on maintaining the sense of cautious optimism as I expressed in the second quarter and feel good that we are progressing in the right areas. So with that, I would like to provide an update on the short-term priorities that we have been concentrating on since I joined the organization. Turning first to quality remediation, what I want to say here is that anytime we think about quality remediation, I want to be clear that the number one priority we have as a business than I personally have is patient safety. So as we think about our process in remediation, we will always have patient safety first and foremost on our mind. If I think about the activities specifically, our ongoing efforts remain on track and we continue to keep the FDA updated on our progress. And as we have stated before at this time, our quality remediation does not restrict our ability to produce or ship products out of our factories and as a result of that would not have an impact on our supply recovery sustainability. And importantly, we also continue to believe that with the work that we have in front of us this will not put us in a position that will materially impact our financial forecast or projections. In the area of supply specifically we are still not exactly where we want to be, but we are making progress and we are going to remain diligent in this area because we want to make sure that our service levels continue to come up, but our progress in this area continues to increase. And as a result of that our comprehensive supply will not be a barrier to accomplishing our 2018 guidance and I think even more importantly our turnaround timeline is higher than ever. Throughout 2019 though what we need to do is to start shift away from our manufacturing folks focusing on just triaging of product supply and begin to focus more diligently on the rigorous approach to reducing costs in our manufacturing facilities, which will eventually lead to margin expansion for the business. On the commercial side of the business we have continued to build momentum. The combination of stronger sales force engagement, this improving supply that I just talked about, the introduction of new products, all of those pieces coming together are giving our sales organization the traction they need and the traction that we need to be able to keep the organization on pace with the recovery. Relative to new product introductions specifically, we are pleased to see the traction our newly released products are getting pretty much across the board with our surgeons. Notably, we are happy with the growth of Persona Partial Knee which is an important space for us and we are seeing very good uptake on the more recently released Persona TM Tibia. By the way we have now surpassed 1,300 cases in our limited launch process and we feel are getting very positive surgeon feedback. Our two largest upcoming commercial projects which I get questions on all the time, the Persona Revision system and the Rosa robotics knee application are progressing well versus timeline and as a matter of fact both are waiting on regulatory approval. Regarding Rosa knee specifically, we are excited to be ahead of schedule to perform our first case in Australia. In other areas of innovation earlier this month we announced an exciting new collaboration with Apple and Zimmer Biomet mymobility. This technology as you probably have already heard there are some of the media launches that we have had on this, is really a digital platform that allows the knee and hip patients to be better connected to their caregivers. This is throughout the entire episode of care and what’s unique about it is you can do this by using the Apple Watch in the iPhone that the patient would have. What we are going to do inside of this is to make sure that we also have a study that will look at the clinical outcomes as a result of using this technology. This will cross thousands of patients that will participate in the study and as a result of this will be one of the largest evidence gathering clinical studies in orthopedics history. I can tell you through this study and in collaboration with Apple, we absolutely look at changing the patient journey for knee and hip procedures and I think ultimately as a result this will set of new standard in digital healthcare for our space. As these and other new products expand our clinical offerings, I feel even more confident that our portfolio’s capability will be there to differentiate us from the competition and ultimately as a result of that help to drive the future growth of the business. Because our primary goal is in fact driving revenue growth, I want to stress that we will continue to invest in appropriate growth initiatives and that we expect those investments to increase over the next several quarters not decrease. These initiatives are already having an impact and will be crucial to achieving the goals that we have for consistent at-market or better growth by 2020. In addition, we continue to look aggressively at active portfolio management opportunities that further diversify our portfolio and ultimately as a result of that bring up the weighted average market growth of our business. Turning to our culture building initiatives, we have been on an absolute tear relative to this area. We have held mission ceremonies with thousands of our team members over the past six months since we launched the new mission. And I would say that these are very impactful. We come in do a mission ceremony and present in person the mission and guiding principles of this organization. To-date we have met with nearly half of the organization to personally engage with them on the one mission, one culture focus of this business. As much I am happy about that progress, I look forward to reaching every team member with this important message over the coming quarters. So overall, though we still don’t clearly have a lot of work ahead of us, we have made great progress, pretty much across everyone of our top priorities. And so with that, I am going to turn the call over to Dan to get into our financials.
Dan Florin:
Thank you, Bryan. To start off, in addition to Bryan’s comments about our third quarter performance, I would like to point out a few other items that will impact your models. First, I want to highlight a couple of headwinds affecting our revenues including some specific pressure on our other revenue line in addition to the foreign exchange. There are also a couple of items below our operating income that will benefit us over the next several quarters as we expect both our net interest expense and our effective tax rate to come in lower than previously expected. Turning first to revenues, our results will be impacted by disruption related to the pending termination of our U.S. distribution agreement with a bone cement supplier. This matter is still evolving and is currently in litigation. At this time, we anticipate the termination of this distribution agreement may have a negative impact of between $10 million and $15 million per quarter on our other revenue line beginning in the fourth quarter. Importantly, we are actively working to mitigate this issue by transitioning our customers to our internally produced bone cement, but we still expect the net impact will be a revenue headwind over the next several quarters. Regarding FX, the strengthening U.S. dollar over the last several months will continue to put pressure on reported revenues and earnings. To put this in perspective, while our organic revenue growth in the third quarter was above our expectations, the negative FX impact was about 100 basis points worse than previously expected and we expect a similar impact for the next several quarters. Turning to items below operating income, as you model our net interest expense, you should expect modest declines from the $68 million that we reported this quarter. In addition, we have taken advantage of further tax planning opportunities, which is primarily why you see the third quarter tax rate coming in lower than expectations. Because of this, we now expect the tax rate for the full year to be below our prior guidance range. While the points I just discussed will likely move some specific line items in your models, we do not expect dramatic changes to 2018 earnings. In other words, the positive effect of tax and interest will largely offset the negative FX impact that we are seeing in 2018. Turning now to our detailed third quarter results, net sales totaled $1.837 billion, an increase of 1.3% over the prior year period, which represents an increase of 2.3% on a constant currency basis. On a similar basis in the Asia-Pacific region, our sales increased by 7.6%, Americas sales increased by 1.7%, and our Europe, Middle East and Africa sales were flat. Moving down the income statement, GAAP diluted earnings per share for the quarter were $0.79, adjusted earnings per share were $1.63, adjusted operating margin came in at 25.6%, including an adjusted gross margin of 71.6%. A reconciliation of reported net earnings to adjusted net earnings is included in this morning’s press release. These adjusted results exclude $247 million of expenses in the quarter, approximately $148 million of which are non-cash charges primarily related to intangible amortization. The adjusted effective tax rate for the quarter was 16.5%, which brings our year-to-date adjusted effective tax rate to 18.6%. Operating cash flow for the quarter amounted to $484 million and our free cash flow was $345 million. Year-to-date free cash flow totaled $1.49 billion. We paid down $300 million of debt in the quarter bringing our year-to-date total debt pay-down to $900 million. With that, let me turn the call back to Bryan.
Bryan Hanson:
Thanks, Dan. As you have just heard, we are pleased with our progress and I think more importantly and more broadly that the entire Zimmer Biomet team is coming together as one Zimmer Biomet and I can’t stress enough how important that is for us to be able to have sustained performance in the business. And overall, our achievement in the third quarter even though it looked a little better than it was clearly is showing that we have confidence that we are on track with our turnaround and ultimately positioning the company for long-term value creation. And so with that, I am going to go ahead and turn it back over to Cole and move into Q&A session.
Cole Lannum:
Thanks, Bryan. Before we start the Q&A session, I want to remind everyone once again to please limit yourself to a single question with a brief follow-up if needed in the past, I think that’s worked very well to get as many as people in and as many questions as we possibly can do and that’s our goal today. Obviously feel free to put yourself back in queue afterwards, I promise we will get through as many questions as possible and we get to you if we can. With that operator, may we please have the first question?
Operator:
Thank you, sir. [Operator Instructions] And our first question comes from Amit Hazan with Citigroup. Please go ahead.
Amit Hazan:
Great. Thanks. Good morning, guys. So just a question maybe start with gross margin considerations for ‘19 and ‘20 leverage, thinking about leverage from volumes and costs, if I adjust the negative price headwinds, it does appear as though you’ve had some positive volumes really all year in hips and knees, and if that's so, does that potent better gross margin next year? Just trying to get a sense of where volume growth needs to be for you to start seeing leverage? And then relatedly, when do you expect to start seeing the benefit from the rigorous approach to reducing costs in manufacturing facilities that you mentioned, can that be a 2019 event? Thanks.
Dan Florin:
Okay, Amit. This is Dan. Let me first start by saying that we’ve talked extensively about the pressures on gross margin and the fact that we expect those pressures to continue through 2019. And that the primary driver of that is the same driver, which is elevated production costs predominately out of the North Campus facility. And recall that we’ve talked about not only the incurrence of elevated production costs that is tied together with the quality remediation work that we're doing in that factory and the fact that our accounting policy is such that we capitalize those costs and they flow through the income statement as we sell that inventory. So, there's about a one-year lag between incurrence of variances and getting the full impact in the P&L of those variances. So that works the same way as we drive cost improvement. So, as we drive cost improvement, it goes on the balance sheet and then it takes a full-year before that’s fully through the income statement. So, that's why there is a delayed impact from benefit and a delayed impact from incurrence. So, as we sit here through 2019, we’re still going to be incurring the full run rate of those elevated costs throughout 2019. Now our new Head of Operations, Ken Tripp continues to bring in additional resources and as that team triages away from focus on supply recovery, the team will start to pivot towards significant cost reduction activity. We expect that pivot to occur next year, and so I would not expect any gross margin benefit in 2019 through those efforts, that’s more of a 2020 impact to the income statement.
Bryan Hanson:
Thanks, Amit. Next question, please.
Operator:
Our next question is from Bob Hopkins with Bank of America. Please go ahead.
Bob Hopkins:
Oh, great. Thank you. Can you hear me okay?
Bryan Hanson:
Yes.
Dan Florin:
Yes, Bob.
Bryan Hanson:
Loud and clear, Bob.
Bob Hopkins:
Great. Thanks. Thanks, good morning. So, I’ll just lay my questions out here. So quickly for Bryan, I was wondering, if you could just touch on two good things for us. Just maybe for you specific on when you think the supply issues will be fully behind you and also I heard some comments on the robot, but just to be clear when do you expect the full launch of the robotic platform for Total Knee? And then for Dan, the one thing I’d love you touch on is that, when you think about the things you’ve got affecting the income statement going forward, you've got tax rate and your spending and clearly currency is an impact, but the Street is modeling roughly 3.5% earnings growth for 2019, do you think the Street is accurately capturing all those moving pieces? Thanks very much?
Bryan Hanson:
Alright, great. So, Bob, I want to go and get started on the more than one question that you asked.
Dan Florin:
We’ll discuss that after.
Bryan Hanson:
But let me start with the – with supply. I think first of all, I want to be very clear and just kind of reiterate something I've been saying, I absolutely do not see supply as being a barrier to achieving our 2018 targets that we have and I think probably even most importantly, to getting to our turnaround timeline, so, I don't see supply as being a barrier to these things. At the same time, I’m not happy with where we are. The fact is, we need to continue to focus on bringing up our service levels to our customers. We need to be best-in-class in this area. And I got to say, to be able to do that, what I want to hear is my sentiment from the sales organization begins to match some of the backorder reduction in the inventory building that we’re doing and until I get that sentiment at a place where everybody feels confident that they have the inventory they need to go after offensive situations, we’re not there yet. So that’s where we are. In addition to this, we've got to start spending a little more time evaluating the portfolio that we have. One of the best things about our portfolio was the scale. It’s absolutely unmatched. It’s the best portfolio largest portfolio out there, but the promise we have had is it also inhibits our ability to have best-in-class service levels. The fact is we have got to start reducing the size of the portfolio, because it creates a very complex supply chain for us. And I am not going to say that we are going to be able to just out of the gate, because we still have to focus on our short-term priorities, but we have got to look at reducing the number of product families we have, because the number of SKUs attached to those product families is extremely cumbersome. And by the way when we do this, not only does it help service levels, it also has peripheral impact to other financial benefits and efficiencies for the organization. So again, I don’t feel like that we are ever going to where I want to be on service levels until we start to call back the portfolio that we have. And as Dan mentioned before, it is critical though that as we come into 2019, this whole triaging activity that we have around making sure supply is there, has gotten to be shifted. That focus has got to be shifted to cost reduction activities, because as Dan mentioned, the capitalization cycle says that once you start those projects, you don’t get full advantage of them for a year. So 2019 has got to be that pivot period for us to be able to get after cost reductions and stop focusing so much on this triaging of product supply. So on the robot, I mentioned that we are ahead of schedule actually and I will give you a little more color on that. We actually had 5 cases that we were able to do in Australia and I want to be clear that this is the beginning now right of us getting out and actually doing cases, actual surgical cases and this is ahead of schedule. There is no question, it’s ahead of schedule. First of all, I just want to say that when I referenced ahead of schedule, I want to be clear. That gives me confidence that the overall project is on track that we don’t have a lot of risk in the project, but I wouldn’t get too excited about the fact that it’s ahead of schedule. I have said in the past whether we limited launch in the fourth quarter or the first quarter, it doesn’t really make the big difference to the rollout plan and I don’t think it will have a material impact on our revenue results, but I am pretty happy with the fact that we are ahead of schedule right now, because that clearly tells us we are in the right place and now we are waiting on regulatory approval in the U.S. Also, little more color on the procedures in Australia. We did 5 procedures in one surgical day with one surgeon, so think about that, that’s 5 procedures which is pretty decent low for a surgeon in a typical surgeon, surgery day with one surgeon and that would speak to the efficiency that we are looking to bring to the table with our robotic system and this is the first time if the surgeon has used the system in the operating room. So not only are we ahead of schedule, but that’s a pretty good stat that we feel good about. The thing I do want to concentrate on though in answering your question specifically is I do want to think about this as being kind of a back half full launch of 2019. This is consistent with what I have been saying we are going to have the full product portfolio in the back half of 2019 that then positions the sales organization to go on 100% offense and then ultimately that keep us in line with that 2020 turnaround, which is where we are going to be at weighted average market growth consistently. And I think that’s important. One of the things I will say though is that full offense that I am talking about I don’t expect this to be in full offense with a similar portfolio offering as everybody else. I truly do believe as we continue innovations like the collaboration with Apple as we leverage the differentiation we already have with things like Persona and we have that full product portfolio, I believe that we are going to be differentiated versus our competition and we are going to bring more ammunition to the pipe. At the end of the day, we are not here to play, we are here to win and I truly do believe this portfolio is going to position us to do that.
Dan Florin:
And Bob, with respect to 2019, first and foremost to be clear we are not providing 2019 guidance on today’s call, we will do that in the coming months. But let me try to provide some color to help folks with their models. First, with respect to revenue at current FX rates as we look to 2019, there will be more than 100 bps of headwinds on reported revenues in 2019 versus 2018 and I mentioned the bone cement transition that also will be a bit of a headwind for the next several quarters as I said in my prepared remarks. On the positive side, as Bryan just said, continued supply recovery, the important new launches that we have coming all feed a growing momentum in the base business. With respect to earnings per share for 2019, again some headwinds and some positives; first, with respect to headwinds just relative to our last earnings call if you look at the combination of foreign currency and the bone cement issue together those represent about a $0.15 per share headwind for 2019, with probably more than half of that coming in the first half of the year. I spoke to gross margin earlier that will continue to be pressured through 2019 as well for the reasons I have discussed and importantly we are going to continue to invest in the business for growth as we have been talking about. Now on the positive side, again relative to our last earnings call, we do anticipate lower interest expense and a slightly lower tax rate through 2019, which will make up for some of that incremental EPS pressure coming from FX and bonus amount. And we will continue to work through the other moving parts in the 2019 financial model. And when you put that all together for the reasons that I have stated, I would not expect operating margins to expand in 2019, but again we will provide more specifics when we provide 2019 guidance.
Cole Lannum:
Thanks. Next question please.
Operator:
Our next question is from Josh Jennings with Cowen & Company. Please go ahead.
Josh Jennings:
Hi, good morning. Thanks gentlemen. I was hoping to just follow-up Bryan on your comments about portfolio rationalization and just to get a sense of have you taken advantage of some supply constraints to begin the rationalization of the portfolio, I think you are coming up on the third year anniversary just pass through the anniversary of the Biomet acquisition and just wanted to hear some more details around how you are going to pursue that process and does that risk your return to the weighted average market growth that you are pursuing? Thanks for taking the question.
Bryan Hanson:
Yes. Josh I appreciate the question. So it wouldn’t risk our Pursuit of that weighted average market growth if we do it the right way. Here is – first of all we have reduced certain SKUs already, we are just not anywhere near where we need to be. In reality we have got to be cautious at how fast we pursue it because let’s say we have had supply issues as an organization for all the reasons that we have referenced in the past, the worst thing we can do right now when we have been stressing our surgeon partners because of the supply issue is the start taking away products they know and love. And so we do have a sequence this thing appropriately, get to that place where we feel confident that supply is in good shape that our field sales organization feels the same way as well as our surgeon partners. And at that point we begin the process of removing families that don’t make sense anymore with the strategy that we have. But to do those concurrently it would put too much pressure on our ability to service our customers and I think we frustrated customer right now, that’s the reason why we are pacing it. I just throw it out there because it is something we will have to tackle as an organization to be able to get to the service levels that I would expect of our organization. So that’s kind of where we stand with it right now, it’s something we are going to pursue we just got to sequence it in the right way.
Cole Lannum:
Next question please.
Operator:
Our next question is from Rick Wise with Stifel. Please go ahead.
Rick Wise:
Good morning. Let me start with – I will just ask my three questions as well, FDA basically Bryan what’s next, where are we, are you feeling encouraged that the progress you are making there. And maybe a question for Dan, Dan obviously free cash flow, debt pay down as the priority, maybe just help us think in broad terms about free cash flow driving initiatives and how we might think about if u are generating a couple of billion and round numbers of free cash flow this year, what that might look like in ‘19 and beyond? Thank you.
Bryan Hanson:
Alright and great, Rick. I will start with the FDA, really nothing more than what I had in my prepared remarks. The fact is we are diligently pursuing the remediation activities that we need to put in place. We are on track with the timeline that we would have expected for that remediation. We continue to put patient safety first and foremost in our mind. I just want to make sure that I say that, if we ever feel that we have a risk to patients that would change the trajectory of that remediation. Certainly we don’t feel that way and that’s why we feel we are on track. So and again to the extent that we can we are trying to keep the FDA informed with everything that we are doing and make sure that we stay as close to them as possible. But I guess that’s really all I have to say. We are on track with the remediation timeline and we feel confident with where we are in that process.
Dan Florin:
And Rick with respect to free cash flow and debt paydown, year-to-date, our free cash flow is $1.049 billion. So, good free cash flow for the first three quarters of this year, so we’re on track to deliver free cash flow in line with the guidance that we provided at the beginning of the year. And clearly, our priority as we’ve been saying in terms of what we do with that free cash flow is to pay down debt and pay the dividend, that's really the – where our focus is. We’ve talked also in the past about capital allocation first-and-foremost to pay down debt to get leverage inside of three times, we’ve talked a lot about that. And we have a host of free cash flow initiatives that we've been executing last year, this year and we’ll continue to do so, everything from basic working capital improvements to productivity of instrumentation and those will continue certainly as we look at our cash thresholds particularly the quality remediation burn rate. We expect that to start to wind down through next year that will be a source of free cash flow as well. So, we still feel as part of the turnaround that we’ve talked about that our increased financial flexibility will start to show itself exiting next year.
Cole Lannum:
And Rick, you threw out a number of a couple of billion in free cash flow in line with what Dan just said, while I look forward to the day when that is the correct number. I just want to clarify here that Dan’s comment earlier on our free cash flow expectation for the year, which remains unchanged is $1.2 billion to $1.35 billion, just a little bit south of the $2 billion number that you threw out there. Operator, next question please.
Operator:
Our next question is from David Lewis with Morgan Stanley. Please go ahead.
David Lewis:
Good morning. So, just questions for Bryan and they’re all kind of centered around growth. So, Bryan I'm just trying to align a couple of messages. You’ve talked about not being able to sustainably grow 2% to 3% until 2020, but you're also making progress. So, my way of math is next year's numbers should be somewhere between 2% and 3% on the high-end obviously not going to get there, but better than the growth rates you're putting up in 2018. Could you just talk about the messaging for the fourth quarter, first of all, is that likely to slow from the third quarter, and is it a reasonable assessment to think about 1.5% to 2% next year is somewhere between 18 and 2% to 3%. And then related to that, this particular quarter spine was the only business, frankly, that didn’t take a step forward. Can you just sort of talk to us about the distributor challenges in spine and how they may reverse themselves next year? Thanks so much.
Bryan Hanson:
Sure.
Cole Lannum:
Before we get there, I want to remind people again, guys, one question per caller, please don’t make me come in and do this anymore. It really helps. Bryan, please continue.
Bryan Hanson:
Okay. So David, just maybe I’ll start with the revenue growth discussion. So, in the fourth quarter you're accurate. I think what we’re trying to get everybody to recognize is that we will likely see less growth or we’ll see less growth in the fourth quarter revenue growth rate than we did in, in Q3. So your assumption there is accurate, that is the message we’re trying to send. Lot of that has to do with the timing that we referenced and also the cement issue that Dan talked about. When I think about beyond that we haven't given any guidance at this point beyond 2018, but I want to continue to reference the fact that I do believe that the turnaround would require us to be in that 2% to 3% consistently. I expect that to happen in 2020. And obviously, if we’re saying that would happen in 2020 consistently then it would be some number below that in 2019. We haven't given specific guidance, but when the time is right, we will. Relative to the spine distributor, a situation I think we’re progressing pretty well to be honest. Just remember, we have a complete restructuring of the channel that is ongoing as we’re delivering the numbers that we are. So, what the risk would have been inside of this is as you’re doing it, you actually see a deceleration in that growth. And the fact that we’re maintaining the growth rates that we are tell us that we’re kind of driving down the street changing the fan belt at the same time and it's working. And so I’m pretty happy with the progress that the team has put into place. And I expect as we work through the end of this year, we’ll be in a place we need to be with the sales channel. And the hope is from that point we can begin to accelerate, but the fact that we're staying where we are while we’re making all of these changes is actually a positive thing. Dan?
Dan Florin:
Yes, I have nothing to add. I mean, I agree with what Bryan said with respect just to reiterate the fact that our revenue guidance for 2018 remains unchanged other than updating our FX assumptions is the only thing I would add to what Bryan just said.
Cole Lannum:
Thanks. Next question please.
Operator:
Our next question is from Isaac Ro with Goldman Sachs. Please go ahead.
Isaac Ro:
Good morning. Thanks. Bryan, just want to try and get a little clarification on your comment to the beginning of the call with regards to the timing benefits you got from some of the tendering capital sales items. Could you maybe try and quantify a little bit what that meant to the quarter, so that as we look at next year we have the right comp in mind? Thank you.
Bryan Hanson:
Yes. So, I purposely didn’t give a specific number there, but I will give you some color around it. Dan referenced the fact that in the fourth quarter we are going to be challenged a bit on the cement side of our business just given the distribution change that’s happening. You referenced that would be between $10 million and $15 million. What I would tell you was that when I think about the comps, not the comps, but when I think about the timing issues for both tenders and capital, if I combine those it’s a number smaller than that, it’s a number smaller than that. So, the benefit that we received in Q3 is something under that range and the pressure that we will receive in Q4 will be the same thing, something under that range.
Isaac Ro:
Thank you.
Cole Lannum:
Thank you. Next question please.
Operator:
Our next question is from Robbie Marcus with JPMorgan. Please go ahead.
Robbie Marcus:
Great. Thanks for taking the question. Bryan, when you took over the CEO role at Biomet Zimmer, you said that part of the challenge was regaining the trust of your physician users, but also the internal sales force. Can you kind of give us an update on where both of those stand, because there are key components to the turnaround story? Thanks.
Bryan Hanson:
Yes. I appreciate the question, Robbie. So, I think we are moving well. One of the things that I referenced in my prepared remarks is we have got a few things working in our favor when we look at the commercial organization and as a result of that, our surgeon population as well. We are getting better engagement with the commercial team. There is no question that, that engagement is increasing and it’s being felt across the board. I will say that this is a continuous improvement game and will never be where I want us to be, but if I just think of where we are now from an engagement standpoint with the sales organization versus when I started, I think anyone you ask would say that it’s better and I would say much better than it was, but we will not stop there, we will continue to make sure that we improve in that area. And then of course outside of engagement, supply recovery certainly helps put a positive in the sales reps arm in new products. We have been on track with the new products that we have been referencing. We have been on time. And when you are on time with new products that gives the sales organization alike to what they need to drive the organization forward. And I think the combination of those things is really what’s changing the engagement and the feeling that you have in the commercial organization. We are not where we want to be. We still have opportunity for improvement, but it’s definitely moving in the right direction. And I would say the same with our surgeon partners.
Cole Lannum:
Thanks, Robbie and thanks for sticking to the one question. Next question please, operator.
Operator:
Our next question is from Craig Bijou with Cantor Fitzgerald. Please go ahead.
Craig Bijou:
Thanks. Good morning, guys. Just want to ask on the recon market, so if we collectively look at you guys and maybe some of your competitors that have already announced the recon market books may look a little bit better in Q3 and recognizing that comps are little bit easier. So just wanted to see what your general thoughts on the overall market, did you see any improvement in the market and anything else pricing or anything else that you saw for the ortho market in the quarter?
Bryan Hanson:
Yes. It’s – I usually try to stay away from many of these strength or weakness from a market perspective in a quarter. The fact is we delivered a little better results than we expected in the quarter. Some of that was due to the timing that I referenced before. Some of it is just natural momentum in the business that we are getting based on the other things that I have referenced. But there isn’t anything in particular that I am hearing from my sales organization that would indicate that we saw strength that would be unusual in the quarter. I really do think that for all organizations it was a relatively easy comp in the quarter that made the market look a little stronger than maybe it actually was, but again nothing that I saw in the quarter, I think Dan you probably feel the same way that would indicate to us that there is unusual strength that we could count on moving forward.
Dan Florin:
Yes, I agree. And just with respect to pricing, pricing continues to be very stable. So pricing for Q3 for us was a negative 2.4%, which was in line with if you look back to full year 2017 was negative 2.5% and Q2 was negative 2.5% as well, so very stable price declines in that 2.5% type range.
Craig Bijou:
Thanks guys.
Cole Lannum:
Thank you. Next question, please.
Operator:
Our next question is from Steven Lichtman with Oppenheimer. Please go ahead.
Steven Lichtman:
Thank you. Hi, guys. I just want to follow-up on spine, you talked about the distributor work you are doing. Can you update us on the state of the pipeline there, but you have a number of things coming out in 2019, I think ROSA on spine, perhaps in expandable cages, can you just give us your overall state of the pipeline within spine? Thanks.
Bryan Hanson:
Yes. I would tell you as you said, the new products is everything for an organization and that to have the channel in the right structure as we exit this year, we are going to be able for the first time to actually have in a while to have a kickoff meeting with the spine organization. And I’d tell you when you have a kickoff meeting with an organization that’s ready to go and you introduced new products that there is serious energy that comes out of that and that’s what we expect to be able to do. One of the biggest things that people are excited about obviously is to be able to bring robotics to spine. We are still on track with what we have been saying. We are also waiting on regulatory approval for that spine application for ROSA. And for that reason, we are still on track with what we have been expecting, but yes, we have got new products coming, we have got the channel in the right place and we are going to have our first kickoff in a while with that team coming up here in the beginning of the year.
Cole Lannum:
Thanks, Steve. Next question please.
Operator:
Our next question is from Larry Biegelsen with Wells Fargo. Please go ahead.
Larry Biegelsen:
Good morning, guys. Dan, I wanted to ask about the implied Q4 guidance, just maybe you can help me with some numbers here. I am getting to about negative 2% reported FX, about negative 2% and flat constant currency at the midpoint? And then on EPS, the range is relatively wide, $0.20, so why such a wide range should we be thinking about the midpoint at this point? Thanks for taking the questions.
Cole Lannum:
So, Larry, let me jump in there. I mean, let me be clear on this. We have been clear all year. We are not going to give specific quarterly guidance nor should you ever assume a midpoint being a more likely number than any other number in the range. While offline I am more than happy to take you through all the different puts and takes that we have talked about publicly here and get you through the numbers. We are not going to speak to specific numbers or answering questions about guiding to a specific number in a quarter, we are just not going to go there.
Bryan Hanson:
And I would just add, agree with Cole and we have provided a fair bit of information that should enable you to model Q4 revenue and EPS for that matter. And just to reiterate that our revenue guidance remains unchanged other than updating our FX assumptions for the year.
Cole Lannum:
Yes, Bryan. I think Bryan specifically had talked about the number of things that affected the third quarter, will affect fourth quarter. I think directionally we are giving you a lot of color here. And in fact we are giving you a lot of color about 2019 in an environment where we are not even giving specific 2019 guidance yet, but I think we are going to draw the line there and not get anymore specific qualitatively, okay. Next question please.
Operator:
Our next question is from Glenn Novarro with RBC Capital Markets. Please go ahead.
Glenn Novarro:
Hi, good morning. Just wanted to clarify, Bryan, the 2% to 3% goal weighted – to get back to 2% to 3% revenue growth by 2020, can you get there through the internal pipeline, it sounds like you may need some acquisitions to get there and if so will you be in a position to do acquisitions in 2019? Thank you.
Bryan Hanson:
Yes. Thanks, Glenn. So no, I think that the 2% to 3% is with the current pipeline. I feel that’s our weighted average market growth. It is what we should be able to get to with our current pipeline. In reality, I would like to see us with the current pipeline be able to do more than, to be able to take share. But what you can count on typically is that you should at least be able to be at your weighted average market growth if you are firing on all cylinders if not higher. When I talk about active portfolio management, it’s because I don’t like the idea of our weighted average market growth being 2% to 3% and the active portfolio management would be focused on getting us in the spaces that are higher growth rate than that build scale in those spaces and ultimately as a result of that increase, our weighted average market growth. So that active portfolio management would be fully intended to get us above the 2% to 3% growth rate.
Glenn Novarro:
Okay, great. Thanks, Bryan.
Cole Lannum:
Thank you, Glenn. Operator, can we have the next question please?
Operator:
Our next question is from Larry Keusch with Raymond James. Please go ahead.
Larry Keusch:
Thank you. Good morning, everyone. Just two questions here. Just you referenced and this is not the first time obviously, but you have referenced increase in investment spending as you move forward. So maybe just talk a little bit about where that investment is going and perhaps, Bryan, some broader thoughts on your innovation engine and how you are thinking about that? And then the second question is just how do you differentiate growth in the total knee application versus sort of any of the other technologies that are sitting out there?
Bryan Hanson:
Okay, great. So when I talk about the investment spending, I am not going to obviously give too any specifics, because I don’t want to make it clear to my competition, where we are going to be spending our time and effort, but it’s pretty consistent broadly with what I have said in the past. Part of that will go to research and development. Part of it will go to our selling and marketing organizations to make sure that we have specialization where needed. So we can drive traction in those faster growth submarkets that we play in and ultimately diversify our growth, so that will continue. But remember as we do launch ROSA as we do try to get additional traction with this collaboration with Apple, that does require spend and that will – when I talk about increasing those investment when we come into 2019, that’s exactly what I am talking about, to launch those appropriately, to be able to get the traction that we need in the field, we need to make sure that we are increasing the spend in those areas, so that’s what I talk about, those are the areas of concentration and that’s the reason for the increased investment. When I think of ROSA differentiation, we have been trying to stay away from speaking too much about telegraphing our talk track associated with what our system is going to do versus anybody else’s. But I think you can get a clue from what I talked about earlier, which is the first surgeon doing procedures with the system brand new, did 5 cases in a typical surgical day. That would tell you something about I know the way that the robotic system will work with the current flow of a procedure. And that will be one of the biggest things that we talk about, won’t get into other things, but just know that, that will be one of the primary things we concentrate on is being able to use robotic system without dramatically disrupting the surgical flow, which is a big deal.
Cole Lannum:
Thanks. Next question, please.
Operator:
Our next question is from Kristen Stewart with Barclays. Please go ahead.
Kristen Stewart:
Hi, good morning everybody. I was just wondering if you could maybe just talk to the big picture from a operating margin perspective. I think on a year-to-date basis you are running around 27.4%, you have talked about seeing some pressure for 2019. I am just curious on how you think about much longer term outlook. Your old colleague over at Baxter clearly has done a great job of improving operating margins. Do you think that there is a similar opportunity here as you look out across the different levers to really generate significant operating margin expansion over maybe the next 3 to 5 years?
Bryan Hanson:
So I am wondering who you are talking about over there at Baxter.
Cole Lannum:
Yes, there are a lot of people. You talked about the ex- Goldman Sachs sell-side analyst or who is that okay?
Kristen Stewart:
Yes, I heard it all David Roman that was responsible for.
Bryan Hanson:
David is doing a great job over there. So obviously, Kristen, given the history that I have with the individual you are talking about, there is similar playbook that we would put in the place here. I don’t know that the opportunities are as readily available as maybe what you have seen there, but there is always opportunity in the business, 100%. And one of the key areas we are going to be concentrating on would be in gross margin. As Dan referenced, we are going to continue to see some pressure as we come into 2019, because all of these costs that we have haven’t quite capitalized in yet, but as we turn the machine on and we start to get after cost reduction in our manufacturing facilities, there is no way that, that doesn’t begin to translate into margin expansion. That will be one of the primary areas we concentrate on. So it will come. In addition to that, we will look at stuff below gross margin, OpEx to make sure that we are truly doing zero-based budgeting that we understand why we are spending and where we are spending and we will look to be able to reduce costs where it makes sense. One of the primary things it allows you to do that is to get better focused on growth drivers, we are not as focused as I would have liked us to be as an organization in selecting the markets, they are going to matter most to us, getting our path to leadership inside of those markets and then differentially spending in those areas. Once we do that that will by default allow us to decrease spending in areas that don’t fit those growth driver categories. With just that mix shift alone and the efficiency we get out of that focus will drive operating margin expansion. So, I am not committing to it overnight that we have already given some color on this, it was going to take some time, but there is clearly opportunity in the organization over time.
Dan Florin:
And I would just add that in addition to all of that as the revenue growth accelerates that natural opportunity to leverage our fixed overhead structure is a big opportunity as well, so plenty of opportunity over time as Bryan just said.
Cole Lannum:
Pretty soon, you will be talking to the people of Chicago and comparing them to the ones in Zimmer Biomet. Next question please.
Operator:
Our next question is from Richard Newitter with Leerink Partners. Please go ahead.
Richard Newitter:
Hi, thanks. I wanted to ask a question on ROSA, so I appreciate your pending FDA clearance for spine in the application. So I am just curious about when it’s ready for commercial launch, should we be thinking of a spine application and the knee application potentially available at some point in the same skin of the platform or are customers going to have to buy separate robots for separate applications? And then also if you could within that answer or comment on your willingness to pursue volume-based contracts as some your competitors have mentioned that they are doing with their robotics platforms? Thank you.
Bryan Hanson:
So out of the gate, well, I want to be clear on, we are waiting on regulatory approval for both the knee and spine applications. They are two different units today. So with spine that will be in the same chassis if you will with brain. So, our brain application and spine application will be in the same robotic system. I think probably everybody knows, but we are already marketing on the brain side. That system is already out and we are actively selling those units. And once we get regulatory approval on the spine side, that unit will also have the capability to do spine procedures as well. Out of the gate, the knee system will be separate. There is an opportunity clearly for us to be able to combine all three applications in one unit. The benefit associated with that is that you are going to get better return on invested capital for accounts, because you are going to get more volume out of the same unit. We are not doing that out of the gate, we are going to be assessing the value of doing that in the future. And if it makes sense, we could certainly make that happen. Relative to the way we are going to commercialize, the robotic system, I don’t want to get too much into our plan here, because I don’t want to telegraph anything, but just we are not in the business of robotic sales, we are in the business of market share. And so we are going to approach the platform in a way that brings the most value to our customers and brings the most value to Zimmer Biomet.
Dan Florin:
I would also like to add just really a shout out to our team that has made this possible, just remember, we acquired MediTech in September of 2016. So in just over a 2-year time period, we are launching ROSA knee with our ROSA spine coming and just tremendous effort by our team. I don’t want to shout them out for the great job that they are doing. We are excited about 2019 on robotics.
Cole Lannum:
Operator, next question. Thanks, Rich. Next question please.
Operator:
Our next question is from Matthew O'Brien with Piper Jaffray. Please go ahead.
Matthew O'Brien:
Good morning. Thanks for taking the question. Just as far as when I look at your performance, the Americas hip number was quite good. But S.E.T., when you back out, I think the benefits you got from the order in the quarter might have been a little bit lighter than I might have thought given how good that market is. So, is this a function of the productivity at the North Campus getting a little bit better on the hip side, still maybe a little bit pressured on the S.E.T. side of the business and if that’s true, is this the kind of snapback we can expect once you get back to more regular productivity out of that facilities?
Bryan Hanson:
So let me try to hit this. So on the hip side, we are couple of things there, if you call it out, we had a pretty easy comp that benefited the number, but we aren’t seeing progress. We have supply recovery, which is helping our field sales organization. We have a grade hip line and being able to have that supply, have our sales organization, utilize the supply is translated into benefit in hip for us. Certainly, in the quarter, you don’t expect those quarters moving forward, because it wasn’t an easy comp that made it look as good as it was. But we are seeing momentum in hip. On the S.E.T. side of the business what I would say is, it is probably a little more hindered on the supply side than hips and knees. But in reality we are still on our trajectory to be able to get improvement in S.E.T., particularly versus first half and second half. We need that improvement that overall growth rate improvement, I like to see it every quarter, but I am going to look at it as, because you always got time in between quarters. We need that improvement to continue and we expect that it will. So we have other product launches in the S.E.T. categories that we would expect to continue to help us. And as we have said before some of that investment that we have been making is specialization in those areas which again should allow us to continue that improvement of revenue growth as time moves on. I am not happy with where we are even let’s call it even if we are looking at the growth rate in the quarter we are in, that was buoyed by comps, we are still not in market growth rate. So we have real opportunity here, real headroom that we need to make sure that we continue to take advantage of.
Cole Lannum:
Thanks. Operator we are coming up on the bottom of the hour, we would look to try to get at least two more questions if we can. Next question please.
Operator:
Our next question is from Vijay Kumar with Evercore ISI. Please go ahead.
Vijay Kumar:
Thanks for taking my question. So maybe one quick one on the distributor termination you guys spoke about, Dan I just want to make sure I heard the numbers correct, so this is $0.10 to $0.15 impact for next year, but there was also some impact for Q4, so is that – does that mean that $0.03 to $0.04 impact in Q4 in the low end of the guidance which implies $2.14 EPS for Q4, you are reiterating that $2.14 number inclusive of this incremental headwinds? Thank you.
Bryan Hanson:
Let me start Vijay, on the guidance numbers I would refer you back to the press release where we have clearly stated which numbers we are reiterating, which ones we are not. What we are not going to do is more interpolate additional numbers based on that, again more than happy to take you through the math offline if needed, but we are not to go through specific numbers down the call as I have said earlier. With that let me turn over to Dan, I think...
Dan Florin:
Sure. Yes. I would just reiterate that what I said is that for the fourth quarter, you should expect the bone cement issue to be size of between $10 million to $15 million of negative impact in revenue in Q4 and that will continue until we anniversary out of that. Now we are doing a lot to mitigate against that number plus that’s our best estimate at this point in time. The second thing I will just reiterate is when I talked about 2019 I said that’s the combination of FX and the bone cement would be a $0.15 headwind on 2019 that we are looking to 2019 earnings, that’s right, yes. And that’s relative to our last earnings call, right, so $0.15 per share next year that will work to offset to the extent possible.
Vijay Kumar:
That’s helpful guys. Thank you.
Cole Lannum:
Thank you, Vijay. Next question please.
Operator:
Our next question is from Bruce Nudell with SunTrust. Please go ahead.
Stan Fediuk:
Hi, this is Stan Fediuk on the line for Bruce Nudell. Thank you for taking my quest. Given the competitors recent move into robotics and spine, do you share the view that a closed system robotics and spine will result in greater pull through of the entire product line, greater ASP and stability and put pressure on lower tier players who don’t have a robotic system?
Bryan Hanson:
I would personally never say it that way. But I do think that having a robotic system whether it would be in spine, whether it would be in brain, whether it would be in orthopedics, recon, I think is a must to have. I think if they are going to be a real player in any of those spaces, you better ensure that you have got a robotic platform that brings some value to the equation. I think it will table stakes to play in my opinion.
Cole Lannum:
And operator, I think we have got time for one more question. Let’s try to do one more question before we wrap up.
Operator:
Our last question will be from Chris Pasquale with Guggenheim. Please go ahead.
Chris Pasquale:
Thanks. Good morning guys. I appreciate you squeezing me in. Hips was a bright spot again this quarter, can you talk about the sustainability of the strength there and maybe contrast the acceleration we have seen in the U.S. hips with the shallower recovery in knees, is the difference in momentum there related to the portfolio, the bigger impact of robotics or would you point to something else?
Bryan Hanson:
I don’t know that I have any more specific comments on hips side of the business. I think we saw – we are seeing traction. Our supply recovery is in place on the hip side. We have a great portfolio. Sales organization is getting traction as a result of it. I just wouldn’t expect Q3 to be a number that you are going to see anytime soon, because the comp was a real benefit to us.
Dan Florin:
Yes. And I would just add to that, that the strength of our portfolio deserves above market growth sustainably as we have just not – we have not been delivering that mainly due to supply and as supply is recovering, you are seeing that in the hip number, but again just to reiterate Q3 was up against an easier comp. But as we look for the future, we are very – feel really good about our hip portfolio and what the team can do with that.
Bryan Hanson:
Yes. I did want to, if I didn’t get a chance to, but the cement thing I do want to spend just a little bit more time on that. We have quantified it obviously in the $10 million to $15 million range in fourth quarter and that’s going to continue into 2019, sorry about the train in the background, but I just want to give some additional color on that. I mean, it’s really frustrating that it’s happening right now, because the fact is our recovery is in full swing. The momentum we have in the business feels right and to have something like this come in that creates a material headwind is beyond irritating. As Dan said though, we are not going to just sit idly by and let this thing just leak from us, we do have an internal bone cement, we will be and already have plans in place to be able to try to pursue this business and stop that leakage, but until we actually get traction on that execution, we want to be very clear this is a real headwind for us that we are going to have to deal with. The good news is it’s a relatively small category. So I don’t expect any peripheral impact associated with this. In other words, cement is not going to have this kind of negative pull-through effect on our recon business. That’s just not going to happen. As a matter of fact eventually, the size and scale of our recon business is probably an opportunity for us to recapture some of this business that we lose over the short-term. And I think probably the most important thing I want to call out here is regardless of the negative impact we have on losing this distribution right here, the fact is we are still on track with the recovery and though it maybe a pain point for us in 2019 and in the fourth quarter of 2018, it is not going to get in the way of that recovery that we have talked about in 2020. It’s a finite thing. It has a beginning and an end. It’s a distribution agreement that’s lost, it’s going to hurt us and then it’s going to annualize out and it’s gone. So I just want to make sure that, that’s clear. I am frustrated by it. It’s a real headwind for us, but it is something that will start and finish and it’s not going to get in the way of the recovery.
Cole Lannum:
So with that everyone, thank you. I know it’s in the middle of early season and it’s a Friday. We really appreciate your time this morning. Appreciate you joining us. As a reminder, a replay of the call will be available later today to review on our website at zimmerbiomet.com. Have a great day and great weekend. Talk to you soon. Cheers. Bye-bye.
Operator:
Ladies and gentlemen, thank you again for participating in today’s conference call. You may now disconnect.
Executives:
Cole Lannum - Senior Vice President of Investor Relations, IRO Bryan Hanson - President and CEO Dan Florin - Chief Financial Officer
Analysts:
Mike Mattson - Needham & Company Bruce Nudell - SunTrust Chris Pasquale - Guggenheim Glenn Novarro - RBC Capital Markets David Lewis - Morgan Stanley Matthew O'Brien - Piper Jaffray Larry Biegelsen - Wells Fargo Richard Newitter - Leerink Partners Rick Wise - Stifel Isaac Ro - Goldman Sachs Robbie Marcus - JP Morgan Joanne Wuensch - BMO Capital Markets Vijay Kumar - Evercore ISI Raj Denhoy - Jefferies Craig Bijou - Cantor Fitzgerald Kyle Rose - Canaccord Jeff Johnson - Baird
Operator:
Good morning, ladies and gentlemen, and welcome to the Zimmer Biomet Second Quarter 2018 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today, July 27, 2018. [Operator Instructions] I would now like to turn the conference over to Cole Lannum, Senior Vice President, Investor Relations and IRO. Please go ahead, sir.
Cole Lannum:
Thank you, and good morning. Welcome to Zimmer Biomet's second quarter earnings conference call, Friday edition. Joining me this morning is our President and CEO, Bryan Hanson; and our CFO, Dan Florin. Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please note that we assume no obligation to update these forward-looking statements even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties, in addition to the inherent limitations of such forward-looking statements. Also the discussions during this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within the earnings release found on our website zimmerbiomet.com. With that, I'll now turn over the call to Bryan. Bryan?
Bryan Hanson:
Thanks, Cole, and thanks to everyone for joining us this morning. Before we get into specific update on our short-term initiatives, our Q2 results and update to 2018 expectations, I would like to just spend a minute on my view regarding our progress as a company and team. As you may remember during our fourth quarter call, I described the business is having more risk than opportunity due to the status of our supplier recovery efforts and quality remediation work as well as our culture building process. On our first quarter call I changed my prospective to a more balanced view of risk and opportunity. Thanks to the early progress we made on the supply recovery milestones and meaningful engagement with the broader organization focused on culture building, including very specific interactions with the field sales organization. As we come into Q3, my current position is one of cautious optimism fuelled by further progress on supply recovery, field execution improvements as reflected by the team's overall Q2 revenue performance and continued traction around the one mission, one culture focus of this Zimmer Biomet team. It's important to recognize that my current sentiment takes into account the headwinds of excess pressure we need to offset and the continued heightened state of risk we must manage while executing our quality remediation efforts. There is fairly much work to be done but I like the progress that has been made and look forward to the team driving towards continued traction. With that said, let me provide a bit more detail for each of our previously stated short-term priorities, which are the ongoing quality remediation, our supply recovery efforts, new product introductions and our culture enhancement activities. Turning first to the status for quality remediation. As we communicated previously and also shared publicly, we submitted our comprehensive response to the FDA's 43 observations stemming from the re-inspection of the Warsaw North Campus. Although we currently have no additional information to share, I want to reiterate that none of the FDA's observations identified a specific issue regarding the performance of any particular product. As a result the facility continues to manufacture its full range of products at this time. At Zimmer Biomet, patient safety is our first and guiding priority, completing our quality remediation to the highest standards of the matter utmost important that we take very seriously. Execution of our remediation plans is progressing with the sense of urgency. However fixing these issues in the right way takes time. I remain confident in the people and the processes we have in place and I can assure you that we will continue to appropriately resource and staff this important work and we will keep the FDA updated on our progress. With regard to supply we’re happy with our progress but we are not completely satisfied with where we are versus our internal steady-state goals. We still have important work to do with regard to manufacturing and quality remediation, which is why we're going to stay diligent in these efforts. That's said, our progress toward a steady supply environment is real and contributed to our performance in Q2 and increases our confidence that supply will not be a barrier to accomplishing our 2018 guidance and the turnaround timeline we previously communicated. Now turning to our new product launches, we continue to have confidence in the products we have already launched and the timelines for the pipeline products still to come. For example, we are very excited about our most recent additions to Persona family, including the Partial Knee system and our most recently launched TM Tibia system, which will be in full launch later this year. Both of these new offerings have gone under very strong clinical feedback resurgence thus far. We also look forward to products launching at the end of the year including the limited launches of the Persona Revision system and the total knee applications for rROSA robotics platform. As a reminder, the combination of steady state supply in the full launch -- and importantly stating the full launch of these differentiated technologies will allow our sales organization to truly go on full offence. In addition to positioning our organization to deliver sustained organic growth, we are committed to active portfolio management to drive diversify growth and enhanced shareholder value. Zimmer Biomet's trusted brand, scale and expertise afford us an opportunity to build leading positions and faster growth of categories. On the culture front, we continue to strive for higher levels of engagement with Zimmer Biomet's team members worldwide. As part of that effort, over the last quarter, I told several mission ceremonies with thousands of our team members to share with them our new mission and guiding principles. Our plan is to reach every team member with this important message regarding the one mission, one culture focus of this organization. We also recently completed a comprehensive employee engagement survey, which has provided us with a clear picture of our strengths and opportunities for improvement within our workplace, as well as a baseline for measuring the progress of our future culture building initiatives. We're encouraged to be most about our results without our team members are overwhelmingly ready and willing to go above and beyond in their roles the global stronger, more innovative company. As CEO, I'm energized by their personal commitment as we work together on the path to future success. With that, I'll turn it over to Dan to go through our financial results in more detail.
Dan Florin:
Thank you, Bryan. Before we get started I'd like to note that this quarter, we are changing the presentations of our GAAP income statement to provide additional transparency. We no longer will use the special items, operating expense category, instead, we will now provide more specific details on the items formally in that category. Importantly, there is no change to our historical or future GAAP or non-GAAP earnings per share. Turning to our performance. Net sales totaled $2,008,000,000 in the second quarter, an increase of 3% over the prior year period, which represents an increase of 1% on the constant currency basis. On a similar basis, in the Asia Pacific region, our sales increased by 5.4%, while our Americas sales increased by 0.9%, and our Europe, Middle East and Africa sales decreased by 1.8%. Our adjusted gross profit margin came in at 71.9%, reflecting a benefit from mix, offset by continued incremental manufacturing and inventory costs as well as the impact of price declines. Our GAAP diluted earnings per share for the quarter were $0.90. Our adjusted results exclude $265 of expenses in the quarter, approximately $110 million of which are cash outflows for quality remediation, business integration and other items. The non-cash charges are primarily related to intangible amortization. Adjusted operating profit in the quarter amounted to $562 million or 28% of sales. Our adjusted effective tax rate for the quarter was 18.9%. Adjusted diluted earnings per share for the quarter were $1.92. A reconciliation of reported net earnings to adjusted net earnings is included in this morning's press release. Operating cash flow for the quarter amounted to $393 million and our free cash flow was approximately $300 million. Our year-to-date free cash flow totaled $704 million. I would like to now turn to our updated 2018 guidance. We now believe that our organic revenue growth for the year will be slightly better than discussed last quarter. However, we are updating our revenue growth guidance to a new range of between 1% and 2.5%. This new range assumes an annual positive impact from foreign currency of between 100 and 150 basis points. This is less of a positive impact on our previous estimates due to the recent strengthening of the U.S. dollar. Given the modest improvement in our base business, we should be able to largely offset the earnings impact of foreign currency, which is about $0.10 per share in the second half of 2018, without affecting our ability to continue making focused investments into R&D and our commercial organization to help accelerate future revenue growth opportunities. Therefore, our original 2018 adjusted earnings per share guidance of $7.60 to $7.80 remained unchanged. It's important also remind you that we continue to expect the third quarter to be hit fairly hard by normal business seasonality. Due to continued strong cash flow performance primarily attributable to increased accounts receivable collections, we are updating our free cash flow guidance to a new range of between $1.2 billion and $1.35 billion. With that, let me turn the call to Bryan.
Bryan Hanson:
Before we're going to Q&A, I just want to reiterate the fact that our second quarter results reflected improved overall performance, as well as continuing progress on our operational and manufacturing goals. I want to emphasize that our second quarter achievements strengthened our confidence that we are focused on the right immediate priorities and that over the long term we are well-positioned to client back in the positive market share of growth. As I've said before, our turn around will take time to complete, and we won’t declare success until we’re consistently delivering top line growth at or above market rates with a competitive operating margin. From where we stand today, I can tell you we still have a lot of work to do to achieve these goals. But as we enter the second half of 2018, I’m encouraged by the progress we're making and I’m confident that we're building a strong foundation to deliver sustainable, long-term growth and ultimately value creation. With that, I’m going to turn it back to Cole, so we can enter into the Q&A.
Cole Lannum:
Thanks, Bryan. We try to reserve the majority of the time on the call this morning for your questions. Before we get into the Q&A session, I would remind you to please limit yourself to a single question with a brief follow-up if needed. I really appreciate if you'd respect the process. Please don’t make me have to cut you off. You can still free to put your step back into queue, if you further questions after that. And that will allow us to get into as many different questions as possible. With that Lauren, may we please have the first question.
Operator:
[Operator Instructions] Our first question comes from Mike Mattson with Needham & Company.
Mike Mattson:
Bryan, it sounds like you're planning to take sort of a portfolio management approach here at Zimmer similar to what you did at Covidien. And I guess what I'm wondering is Covidien had a kind of much wider mix of businesses when you look at growth and margins and things like that. And at Zimmer, it seems like there is more consistent margins and growth rates across the various businesses. So that's the first part of my question. If you can just maybe comment on how you can implement that here. And then the second thing would be just with regard to M&A, are you looking at opportunities more within the existing markets? Or would you consider going more of a diversification drop similar to what strikers done within the recent years? Thanks.
Bryan Hanson:
Yes, absolutely Mike. I just want to make sure the first part of your question I understood, could you just give me a little more color around what you are referencing there?
Mike Mattson:
Yes, so I mean you've talked about portfolio management in order words shutting maybe lower margin, lower growth businesses, why you are looking to acquire things that are higher growth and higher margin. In the businesses like Covidien, there was more of a fix of -- we had some really low margin, low growth businesses and really high margin and high growth businesses. So could you please review that, it seems like the businesses is here of more similar. So that's my question essentially?
Bryan Hanson:
I got you. Understood. So when I think about active portfolio management, I guess first and foremost is, it is another opportunity for us to be able to drive consistent shareholder value. Clearly, organic growth is the primary focus of the organization and we have to get to a place where we are at market of better. But I want to be able to compliment that by ensuring that we're waiting into businesses and markets that are more attractive in the places we're in today. And let me just kind of really put an explanation mark on that. First and foremost, I'd like to scale in some of the areas that we already play in that have better growth profiles in some of our larger businesses. Some of that would be in the set businesses obviously. So our first area of focus will be to add scale in areas where we already play in faster growth sub markets where we have an opportunity to take advantage of the brand that we have in the commercial organization to be able to drive attraction in those places. And ultimately as a result of that, bring our weighted average market growth up. So that will be the first kind of leg of this process. I really want to make sure that we're doubling down in spaces we already play in, build more scale and make sure that we increased the weighted average market growth, and there is plenty of opportunities to do that. I'm not at all opposed as we go into the active portfolio management process and we have more fire power to do so in diversifying the business even beyond some of the areas that we currently play. Again with an eye towards driving the mission of the organization, making sure that it's economically attractive for us to do so and drive shareholder value with an eye towards that increase weighted average market growth. So that's kind of that the phased approach that I would see. It's double down in areas where we already play and drive scale, drive weighted average market growth up and then potentially diversify outside of the spaces as well. Relative to divestitures, which I think is really the first part of your question there. It isn’t just the margin profile that we would look at; it would be really mission alignment. It would be our ability to win in the space given our capabilities versus maybe others that might find our business is more attractive. And the fact is, we love all of the businesses and that we have, not all of them are going to be invested in equally and not all of them have the same opportunity for us. And if any of our businesses are attracted to others of third-parties, that see more value in them than us and they are not critical to our mission, we would contemplate divestiture assuming that we can take those proceeds and apply them to the areas I talked about in the beginning here. So that’s the way we’re going to take the approach. It will be similar playbook that what we have done previously at Covidien and what we done at Medtronic as well. But that ultimately, as you said, we don't have that real difference in margin profile in our businesses. So the margin profile will be one of the primary things we look at.
Cole Lannum:
Thanks, Mike. Next question please.
Operator:
Our next question is from Bruce Nudell with SunTrust.
Bruce Nudell:
Bryan, just looking at major joint market year to date, it looks like it's around 1%, last year is around, and historically, people have thought of major choices 3%. Is there something secular going on? And if there is, is that putting more alacrity in your diversification efforts? Thank you so much.
Bryan Hanson:
Sure. First of all, nothing that's happening right now would have changed our opinion or aggressiveness or stance on diversification. As I wouldn’t read anything into what you may be seeing relative to large joints market growth. And to be honest, as we said in the first quarter as well, because there was a lot of discussion around, are you seeing pressure on volumes in the first quarter, we really aren’t. The fact is when you work the numbers based on everybody's performance over the last two quarters. Clearly, what you're saying about the growth rates is accurate. But what’s interesting about it is you’re not really hearing any company complaining about this market growth. And what's interesting for me too is I’m not hearing my own organization complaining about volumes out in the marketplace as a reason why they can't obtain or drive past the goals that we set. So that tells me that even though we’re seeing maybe a little more pressure than normal, please stay it on the math. We’re not actually seeing an impact in our ability to drive the goals that we have for the year. So, again, I don’t want to read too much into the market growth over the last two quarters. I think it is not a perfect science in the first place associated with looking at these things in a view add up to the major players and there are differences in a lot of things to go into those numbers that I don’t always stated their perfect science on this. But at the end of the day, it's not going to change our opinion on how quickly we’re going to look to diversify. The diversification is a strategy that we had and we will continue to move forward. And again anything that we've seen relative to market growth in large joints does not change our opinion in what we’re going to be able to accomplish this year or beyond that.
Cole Lannum:
Next question please.
Operator:
Our next question comes from Chris Pasquale with Guggenheim.
Christopher Pasquale:
Bryan, can you give us some more color on the supply situation and where things stand today relative to what you were hoping? When you talked about being back to full capacity by the start of 3Q, are there particular categories where you're in good shape today, but others where you still having issues or is it broader than that?
Bryan Hanson:
Thanks, Chris. I'd say, I don’t want to speak to specific categories just for competitive reasons, but and I'm just kind of pretty transparent person. I'm pretty happy with progress that we didn’t hit all the goals that we had set for the first part of Q3, some of its split. And so with that that's won't be transparent with that. That's said we've obviously made great strides in making progress here. And ultimately we're seeing that reflected in the results in Q2. And we're going to, obviously, we’re seeing it in our cautious optimism here because we're seeing supply is not going to be a barrier for us to accomplish what we said in 2018 and we turnaround itself. But before I get into any more detail, I do want to just call out a couple of groups and team members that we have that have made this a reality. Again we're not where we want to be, but the progress is real. And our manufacturing team has done a yeoman's work here. I spent a lot of time on the floor talking to folks that are actually working on the manufacturing floor. I guess that these people are putting in a lot of time, a lot of extra hours to get this company back to where it needs to be. Again still work to be done. But the attitude and work ethic of these folks is absolutely inspiring. When I'm having a bad day, I will go out to the floor, and talk to some of those folks and it turns my day around. So I want to make sure that I call them out because they've been a big part of the progress that we've made. And the group is our sales organization. I've spent a lot of time in the field talking not just to the territory leaders and not just to the reps, but also the folks that are running operations in the field. Again all of these individuals are doing significant work to make sure that the product that we do have gets the surgeons that fills the cases and takes care of the patients. And that is extra work that they are doing everyday in the supply constrained environment. So I appreciate what they're doing. It's a big part of why we are able to get the performance we did in Q2. But here is the thing that I really want to concentrate on, steady stage in our supply is the first step, and we are making progress towards it. Certain brands that are lagging behind but we'll catch those. The most important thing now is to be able to get to steady state and sustain it because at the end of the day steady state supply has to translate into incremental revenue, accelerated revenue. One of the things that we've been doing now is really to find internal city organization. What do you mean by steady state? And beyond the obvious stuff back order recovery and safety stock levels and those types of things. We're also starting now a sentiment survey from our commercial organization. How do they feel about where we are with supply? Because ultimately until they feel confident we are not going to get the revenue acceleration that we are looking for. This is part of process of saying, we're not where we want to be yet. In the Q2 survey that we did just three very simple questions. First one is do we get make progress from the previous quarter. The second one is do you feel confident now with the supply you have, the service to your customers? And the third one is are you ready given the supply and situation to go after competitive surgeons? And in this Q2, we got a pretty good response on was their improvement. We've got a neutral response on can I supply my current surgeons, which tells me that they feel like they can, but haven't been doing it long enough for them to feel comfortable yet. And there was a negative response in the scale that we have and being able to go after competitive surgeons. And again that tells me we're not where we need to be. Because what they are telling us is until I know for a fact that I can supply my current surgeons, I'm not going to take on the additional risks they go after material of new business. And that's where we've got to get. So what I say we still got to make progress here. It's not just getting to steady state, it's maintaining it and getting the sentiment that the sales organization to shift and move to revenue acceleration.
Operator:
Our next question comes from Glenn Novarro with RBC Capital Markets.
Glenn Novarro:
Bryan, a question on the North facility observation. So fewer observations this inspection relative to the last, but they were eight repeat observations and this is made some investors worried at the North facility could receive a warning letter. So could you provide your view on the repeat observations? How fixable are these observations? And your confidence that the remediation plan on the observations will be acceptable to the FDA? Thanks.
Bryan Hanson:
Well, what I would say first is I don't want that get into any specifics relative to any of the observations or how I feel about the observations. We've been pretty transparent in the entire process relative to our quality remediation and interaction that we've had with the FDA. So everything that we provided in our responses to the observations is public. We make sure that you could see that. Not every company would do that, we did it. And so I think you've got what you need in the public domain on how we feel about the observations and our responses to those. What I would tell you is, I think, this is really important. I just want to reinforce that JD as well as myself, we take our commitment to quality and ultimately patient safety very, very seriously. It is the commitment that we make as an organization as a matter fact the new mission that we created. Our monetary right now around the world communicating this mission live and in color to our team members isn’t just an inspirational mission. There are principals inside the mission that define who we are going to be. We are and we’re going to continue to be. One of the primary principles talks about quality, patient safety and conducting ourselves with integrity period. These are not just words in a mission statement. These are things that we will actually define ourselves by. And when I present to the organization and these mission ceremonies, we talk extensively about what that means to each and every one of us. So I just want to make sure that that's clear. Relative to where we are right now, I feel good about the responses that we've had with these observations. I’m 100% committed as is the team to resourcing appropriately to quality remediation in the North campus. I do not like to have an open checkbook policy on anything. But in this particular situation it is an open check book. If resources are needed, the resources are retained and we’re going to move this thing forward. So again, I don’t want to comment on anything specifically. We don't -- we can’t relative to respond into the observations. And now it's just -- the process has just got unfold.
Cole Lannum:
Next question please, operator.
Operator:
Our next question comes from David Lewis with Morgan Stanley.
David Lewis:
Bryan, I wanted to ask about the status share across the business. And specifically, where is share better, where is loss more pronounced? I wonder how is it trending at customers that have historically been through higher Zimmer customers versus where your share has been lower. At this point, how much of your share loss you think is supply related versus the product positioning? Thank you.
Bryan Hanson:
I tell you it's always tough to actually speak specifically to the reasons where we have deficiencies in share. When I say share, I think, what you're talking about is just growth versus market growth and that's specifically where our current stage is relative to overall market share, but a lot of our categories that's basic. We have been growing below market. And that's the very thing that we're concentrating on is a matter of fact we define the turnaround in this organization as overall getting back to market or above market growth in a sustained way. That will require us in our major categories to be able to get to market growth and sustain it. Now we're making progress. And I think some of the progress that we've made in certain categories has everything to do with the fact that we have a great sales organization that is prepared to sell. We have a combination of Zimmer portfolio and the Biomet portfolio, which is second to none. We've been saying that all along. We just got to be over supply it. And the fact is we have the manufacturing team increased the capability in supplying that product. So all those things coming together on some of the culture building as well, has been able to help us start to close the gap where we've had gaps in our performance versus market. We're not there yet and we're clearly not there. I mean that's basic even though we beat our expectations in the second quarter, we're far from being at overall market growth. We need to get there. That's the goal. The things that need to happen for us to feel confident that we can do it is that steady state supply, what we maintain it and we get that sentiment of the sales organization up and translated into revenue growth. We forgot to launch the new products where we have product assets we've talked about in the past and get those in the full launch that needs to happen. And then ultimately we got to continue to drive the culture of the organization to make people believe we can win. And those are the things that we have to accomplish to be able to ensure that when you ask this question in the future, we can confidently and comfortably say we are at market or better in the major categories that we have.
Cole Lannum:
Thanks David. Laura, next question please.
Operator:
Our next question comes from Matthew O'Brien with Piper Jaffray.
Matthew O'Brien:
Bryan, there has been a lot of discussion on the call about diversification or maybe into the faster growth areas, you've got very good free cash flow, the leverage ratio, I think, is less then 3x now. But you've got this manufacturing issue. So is that the biggest gaining factor to you going out and doing some more deals need to get you into faster growth areas that are already in or other areas? Is that something where we should think of you getting more aggressive maybe six to nine months after you feel better about where manufacturing is at?
Bryan Hanson:
John, first of all I just made a quick correction that we're not yet from a leverage perspective under 3. It was still 3, slightly above 3. The goal would be to be below 3 and we expect to be able to do that in 2019. But John, what I would tell you is in a perfect world if you are sequencing this, we would do exactly what you just said. We would focus first on our short-term priorities as we've previously stated. Those short-term priorities would get us to the point where we were steady state as a business, which would mean in the spaces that we already play with the businesses that we already have in our major segment that were growing at or above market. Once that's stabilized, then we would start to get into more active portfolio management. But in reality, what we know is you can put best way plan never survives first contact with the enemy, right. And so that plan, in the realistic world, says if we are opportunities in spaces that we know are attractive to us become available and opportunistically we can wait into those we're not going to ignore them. And we do have the fire power now to do smaller tuck-ins. And so if those opportunities become available to us, even if we haven't gotten to the place where we're defining our business as steady state, we would take advantage of those opportunities, if again they maybe on extent and we thought they could drive shareholder value and importantly we drive the mission for the organization. So if we can sequence it perfectly would be the way you said putting the real world, it doesn’t always happen that right.
Cole Lannum:
Thanks, Matt. Next question please.
Operator:
Our next question comes from Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
So by my math the guidance implies about one 1% to 1.5% constant currency growth in the second half. The question is do you expect that sequential improvement in the constant currency growth rate in Q3 and Q4? And what are you assuming now for resolving the supply constraints are not drivers that any response by to Chris' question earlier. Thanks for taking the questions.
Bryan Hanson:
Dan, why don't you take the first part of the question? And then I'll handle the second one.
Dan Florin:
Sure. So Larry the second half implied constant currency growth rate about 1% as you are suggesting. The Q3 to Q4, we’ve not given specific guidance on the phasing of Q3 to Q4. The comps are different. The seasonality has been difficult to the nail precisely Q3 to Q4. But feel good about that about 1% second half constant currency growth that’s implied in our guidance.
Bryan Hanson:
One lab that you would expect that giving typical seasonality Q3 would be more pressure than Q4. What I would say on the supply recovery, I think why I want to answer it is, there's work to be done in certain brands, but we feel confident given where we already are. And that where we nowhere going to exit in Q3 that this is not going to get in the way of us delivering what we just said in 2018 and will absolutely not getting the way if the turnaround time that we've communicated in the past. To me the most important thing at this point is to get the sentiment of the organization up to be the sales organization so that the translating that supply into revenue acceleration. But again I just want to reiterate, we do not see supplies being a barrier to our ability to deliver what we said.
Cole Lannum:
Thanks Larry. Next question please.
Operator:
Our next question comes from Richard Newitter with Leerink Partners.
Richard Newitter:
Just wanted to focus on the S.E.T. business. This was a little bit representative narrowly of underperformance relative to our forecast was, obviously, your recon was better. I'm just curious, with respect to an earlier question that was asked how much is supply versus product gaps driving that within the S.E.T. business. Can you talk a little bit about whether that's more impacted perhaps from a supply issue relative to recon? And I'm also going to just ask if you can comment on the stemless shoulder launch. I would have thought if it's not supply that might have helped that division. Thank you.
Bryan Hanson:
So first of all stemless shoulder going well. As a matter of fact we're just talking to shoulder surgeon last night at dinner, and that he was commenting how excited he is about the launch. He is using the product already and he has had very good results. So I would just tell you that we remain confident and comfortable with our expectations around our stemless shoulder in just the shoulder space in total. What I would say is you're accurate. The S.E.T. business -- first of all, not all of our brands are impacted equally relative to the speed at which were recoveries supply. And in the second quarter, the S.E.T. business was pressured a little more than large joints when it comes to supply recovery. So that was part of -- some of the performance of the business in the quarter. But the other thing too is we decide some timing quite frankly of capital that will benefit us in the back half of the year that just didn’t translate into the second quarter, so that's some of it as well. In the final pieces, we've actually has some good convergence in the set business. I'm not going to speak specifically to where, but across the S.E.T. business. And a lot of that's not going to translate until Q3 and Q4. So I feel good about our progress in S.E.T. I feel good about the supply recoveries we come into Q3. And I think what you're going to see in S.E.T. is our ability in the back half to have better performance than we did in the first half.
Cole Lannum:
Next question please.
Operator:
Our next question comes from Rick Wise with Stifel.
Rick Wise:
Maybe highlight some if you would give us little more color on the challenges you are facing in the EMEA region. You called out the weakness there. Maybe help us understand some of the softness drivers. Is there a specific geography? What's the pathway timeline for recovery? Is it a small fix? Is it portfolio? Is it people? Anything to help us understand find that would be helpful.
Bryan Hanson:
So what I would say is if I may, it was a little wider than what we have contemplated for the second quarter not dramatically. So to be honest, that a little wider than what we had thought. And a few reasons that I would point to you, I think, first of all, supply constraint was renowned in Q2. It probably impacts Europe a little more than other areas just given the tendering process that occurs to be able to get in certain tenders and win those tenders you have to have a full portfolio available. It has been always the case and other regions in the world. So it does intend them maybe a little differently strictly depending on where you are in Europe. That's one thing. The other is we have some tender timing, not lost tenders, but just tender timing that's going to push us towards the back half of the year where we thought we're going to get those earlier in the year and that's real. And then noticed being honest, we had Katarzyna lead the organization. She has been in place for a long time. Whenever you have a senior leadership shift like that, there's always a risk for some level of disruption. And so I don’t want to say that there isn't that. I don’t see it is being material. But the fact is -- that there's some level of disruption that you got to assume is happening. At the same time I've spent a lot of time in Europe with the team underneath Katarzyna and we have strong players. I have a lot of confidence in the team. I feel very confident that they are going to continue to be able to steward the business, and I don't see us having a falling knife situation here at all. At the same time I don't necessarily believe we're going to see a quick turnaround either. I would say that the back half of the year was look pretty similar to the first half of the year when we're talking about that region of the world. So again not a major concern. It's not far-off of our expectations in what we assumed so far of the year. And the performance of EMEA throughout the rest of the year has already contemplated in the expectations that we just provided.
Cole Lannum:
Laura, can we have the next question please.
Operator:
Our next question comes from Isaac Ro with Goldman Sachs.
Isaac Ro:
Quick question just as a follow-up to [Indiscernible] Bryan can you talk just a little bit about how much time you're spending when it comes to recruitment whether it would be in sales force or leadership team? Just kind of adjusted in the progress there some of the things that you're doing there put into place that the people who you want maybe are harder for us to see on the outside. Thank you so much.
Bryan Hanson:
For me it’s a big part of what we need to do in the organization is just to increase this kind of one Zimmer Biomet mission and culture. And I don’t want to -- sometimes people put this as a secondary thing, but to me, culture and mission any organization is absolutely critical -- it's absolutely critical. We have great people in his organization. I don't need a wholesale change of leadership or folks in the organization, I have confidence in the team. What we need to do is to create a framework. And in an environment where these individuals can perform and the way that I know they can. And talking about the mission of the organization, getting people excited about the culture of the organization he fact that it's one team, one five goes long way to unleashing the capability of the people we already have on this team. So I just don’t want there to be a sense out there the investment community or anywhere else that we don't have the team members needed to be able to make this business turnaround. I feel confident that we do. We just got to create an environment that allows them to do it. At the same time, in certain critical areas, we have added talent from outside the organization that I think will help increase the capability of the organization that turn things around. Our Head of Operations, as I said in the past, is new. That individual is bringing additional people in that I think will help us in capabilities where we have certain gaps today. Again not that we don’t have a great team already but we’re adding additional capabilities that I think will only help. We’ve done the same thing in our portfolio management strategy area. We upgraded talent there. We’re going to continue to do that. And my senses will continue to see additional folks come onboard underneath Rachel and that gives me more confident that we are going to have a sound strategy and even more focus in this organization to ensure that we're applying our resources to the areas that kind of bring the most value to the organization and ultimately our shareholders. So we’re making changes in addition where we need to but make no mistake. We have a very good team and we’re creating the environment where that team can be unleashed.
Isaac Ro:
A follow up on …
Cole Lannum:
No, no. Isaac, one question. Get back into queue and we will put you back in the queue if we have time. Okay? Next please.
Operator:
Our next question comes from Robbie Marcus with JP Morgan.
Robbie Marcus:
Dan, two very quick financial questions for you. One on EPS spacing for the back half of the year. Historically, Zimmer had a drop of 15% in EPS from second quarter to third quarter. How are you thinking about that with this year? And then maybe just give us an update on I know your FX hedges will flow through gross margin. What are you thinking of the impact gross margin in the '18 and '19? And any color on EPS impact form FX next year would be great? Thanks.
Dan Florin:
Sure, Robbie. So first on phasing Q3 to Q4, it's certainly appropriate to look back over the past number of years and look at that seasonality its significant in our business and you see it every year. In particular, when you look back at Q3 of last year from an earnings perspective, recall that we made some bonus accrual adjustments in Q3 of last year, which was a benefit to the P&L as we trued up those bonus accruals. So we came into this year from a full year guidance perspective and talked about that as a significant year-over-year headwind and there is a significant item in Q3 about the headwind. So I think, as you model Q3 versus Q4 just know that inside of Q3, you've got this big credit in Q3 of last year that won't be there in Q3 of this year because thus far we're performing. So while I'm not going to give you the precise phase in Q3 and Q4, I would just remind you to look back at revenue seasonality of the corresponding OpEx that is expect various variable and then just know that the prior year Q3 had that credit inside of it. With respect to hedges, in my prepared remarks, I talked about a total FX headwinds earnings of about $0.10 in the second half of the year, given the sharp move in the U.S. dollar since our call in April, so that movement about 5% strengthening of the U.S. dollars while we have a very robust hedging program, the sharpness of that move really prevents us from completely offsetting that in the P&L. So the $0.10 headwind would have been significantly worse if we didn’t have a heading program. And the offset for the heading program will flow through 2019 as well. So last piece would be when you think of gross margin 2018 to 2019, we've talked a lot about the headwinds in 2018, we talked about the incremental production costs that were still incurring, the capitalization policy that's associated with that. And therefore when you think about '19 versus '18 you're still going to have a bit of a headwind on the gross margin rates due to pricing and then also that that incremental pause that would still be followed through the P&L.
Cole Lannum:
Robbie, let me add one more thing on the sequencing thing. You mentioned the 15% number. I won't be clear and Dan just had said this as well. There is a mean of necessary we're going to have an exact 15% kind of impact. We're not going to talk about specifics there. It could be higher than that, it could be lower than that. I think the reason why it's important to know that we pointed out is a lot of people on the street have got that right. It's very, very straight forward it's how it happens every single time, a lot of surgical oriented companies see that seasonality shouldn’t be a big deal. And if you want those people than you are in a good shape. We have already receive three people out there though that may have not fully understood this SG&A dynamics again we're talking about and we just going to highlight this so that when you do the models you go back you take a look at that you understand that's SG&A in particular comp has a real impact there. And of course happy to go through all this offline with anyone if there is any confusion on that okay. Thanks a lot Robbie. Next question.
Operator:
Our next question comes from Joanne Wuensch with BMO Capital Markets.
Joanne Wuensch:
I want to fast forward to a year from today. And I think, everyone on this call understands that this is a shift, a progress, a gradual improvement, pick any out to you want. But a year from today what is a win and what will you be saying or could be saying that will be deemed to disappointment? And the second question to that is when you think you stop losing market share?
Bryan Hanson:
Well, the sister question is kind of buried in the first question anyway. So what I would tell you is a year from today, I hope we're not saying anything, that’s a disappointment to where we thought we would be. Here is the imperfect timing actually to be a year. A year from today what we need to be saying and this is our short-term objective is number one we have gotten to the place where steady state in our supply has been maintained in the sentiment of our organization, particularly the commercial organization, realizes this and does not have concerns with pursuing new business as result of supply constrains. That has to be in place. Second piece that we talked about, we've got to launch the products that we've been openly communicating are important to the portfolio to get our reps back on full offense and we need to get them into full launch, which by the way around the year from now would be the timeframe that we should be in full launch of that full portfolio. So if we’re at that place with supply recovery and we continue to make progress on the culture of the organization, particularly, again, around our commercial organization, I think we’re in a position to begin to go on through often. Now what I do know about being in a position going to offense and actually realizing it, there's typically some period of lag between that. We’ve got to build up your bolt-in of offensive opportunities and ultimately translate that bolt-in build in into convert the business. So my feeling is as we’re coming into a year from now, those three things will be happening and will be able to talk about the offensive position that we’re in. And then ultimately, as we've talked about the turnaround to the business, we want to be at or above market growth in a sustained way and we truly do we believe that can happen in 2020.
Cole Lannum:
Thank you, Joanne. Operator, can we have the next question please.
Operator:
Our next question comes from Vijay Kumar with Evercore ISI.
Vijay Kumar:
Maybe going back to the guidance question. So I just want to understand the 3Q in 19 comments where it's a 3Q, obviously, there is seasonality. And what I think, I think there is also days impact make the composite easier supplies coming back up on. And I just want to understand how all of those things ready together. And I think relative to that the FX impact for 19 at current levels. I think, on the last call we said that we expect the operating leverage. I just wanted to understand that is still impact right given where rates are currently? Thank you.
Dan Florin:
Sure. I would just say that our guidance for the second half of the year takes into account everything that you just said. It takes into account the comps from the prior year, takes into account in improving some live situation that Bryan is referring to and the FX movements. So that’s all factored into the second half guidance. With respect to 2019 operating margin and Bryan talking about the comments on this as well, we’re going to stay focused on delivering what we’re talking about here in the back half of 2018 first and foremost. We’re going to see how that goes. And we will continue to have a bias for investment in areas that deliver returns from a growth profile perspective. So when we look out next year as we go through our budgeting process and see how the year is progressing, we'll look for additional opportunities to invest to drive growth. And I think it's fair to say that if we see opportunities to do that we will priority over that relative to driving operating margin expansion.
Bryan Hanson:
I don’t know if I have anything material to add, well said. I mean to me, I think to us as an organization and probably to you as well, the primary goal of this organization has got to be to get revenue growth up and get it up in a sustained way. That will be the primary focus, and that will be our Northstar. When we accomplished that then we can truly look at operating margin expansion, but I would give up on operating margin expansion in the short-term to be able to drive revenue growth. And when we do see those opportunities, where we getting traction in areas where we're making investment? We will double down in those areas and continue to push even if it impacts our ability to get that modest expansion we've been talking about in 2019 for margin.
Cole Lannum:
It's a good point. I'm glad that you brought it up Vijay. Operator, next question please.
Operator:
Our next question comes from Raj Denhoy with Jefferies.
Raj Denhoy:
Maybe a two-part question Bryan. The first would be on new products. You mentioned the importance there but you did have some launches in the quarter Partial Knee, the Tibia was out there and then you have two slated three year. And so what is now baked in there just from the --let's call the partial launch of those products and guidance. And the second question would just be on portfolio management. Dental was below our expectations. Just wondering what the strategy is there and what the company contemplate potentially a spin or a divestiture of that asset going forward? Thanks again.
Bryan Hanson:
So first of all when I think about the new product launches, I think the primary thing that I'm looking forward here just across the board, you forget for a minute new product which is across the board. Are we as an organization doing what we say we're going to do? It is very important to me. It's one of the culture pieces that we want to have as one Zimmer Biomet. When we say we're going to do something we do it. And if we get any challenges in the process we pivot inside of those and we make sure that we ultimately accomplish what we said how to accomplish. That's one of the things that I'm really concentrating well in the organization. And we're sending that message loud and clear. What I'm happy about on the new product side as we are delivering on what we committed. We've been hitting pretty much on target, all product launches that we had committed to. And I'm taking about internal commitments to timelines not just the external commitments that we've made to you. And we're delivering on the expected revenue growth associated with those new products. I'm not going to get into specifics. We just know that the revenue growth that we expect from those products is coming to bear. And ultimately it is built into the guidance and expectations that we set for the back half of the year and beyond. So I feel really good about that. I feel solid about where we are. Relative to specific new products, across the board where we've launched, the response from surgeons is extremely positive. I just can't wait on the cement less side to get the full launch because the response associated with that product so far is extremely positive. And full launch is becoming at the end of the year. And it's not remembered just about the revenue associated with that individual products, it's the potential pull through of other categories and our ability to get back to market using other categories. This new product gives energy to the sales organizations and ultimately gives energy to our surgeon partners. So again I'm very happy with what we see thus far. I mean we still have a lot to do. We get major products we still have to launch, but every indication is that we're still on track to delivering those limited launches as we've been communicating. Specifically dental, I would agree that the dental market is a tough market for us right now. It remains very competitive. And we've been, as we've previously stated, making changes within the dental organization to senior management. We're continuing some of those changes within the dental organization to try to position us to be able to compete in a more holistic way. The key thing that we put in the place to stabilize we got to stabilize that was dropping for equipped. We want to at least stabilize that drop and then try to move into a position of growth. Fairly we haven't got to the second phase of that plan. We have stabilized little wonder where we want to be in the second quarter, but it's not in consistent with previous quarters. The real goal for us there what to use the momentum of that new team and begin to get traction in the dental business. That's where we are with the dental business.
Cole Lannum:
Thanks to ask me although I would note that sounded suspiciously like more than one question that you asked, but I'll note that for you after the call. During the time shifts, I’m real quick, we’re going to have time for maybe two or three more questions we're going to try to get them through if we can. Operator next question please.
Operator:
Our next question comes from Craig Bijou with Cantor Fitzgerald.
Craig Bijou:
I wanted to ask on the spine stemless business. You guys obviously saw pretty good step up there in the quarter. So just wanted to see what the driver was there? And then maybe your overall thoughts on the spine market and the growth profile of your specific business going forward?
Bryan Hanson:
Yes, so I would say, I'm, again pretty happy with where we are right now with that segment of our business. Big part of it is we've just made, I just talked about the dental business, we've made some management changes and some structural changes to that segment of our organization. We got some new team members in almost across-the-board in spine. But also in other categories of our business that I think are setting a really strong strategy. They began to implement a channel strategy that provides risk because there's change in the channel strategy that is needed, but progressively moving that forward and having good success so far as indicated by the Q2 number. And we continue to feel confident that we’re going to be able to deliver what we expect in the back half. So I’m excited that some combination of a new team, new products that we’re launching and a channel strategy that we’re putting in the place that's all coming together to be able to allow that business to perform that plan or even slightly better.
Cole Lannum:
Thanks for that. Operator, next question please.
Operator:
Our next question comes from Kyle Rose with Canaccord.
Kyle Rose:
Earlier in the call you talked about the rose in the application coming on track for launch. Just want to see if you can frame that out in terms of how you really define a control launches 10 robust to 20 robust? Is it similar customers? Is it competitive customers, the DeNovo robot users versus experienced robot users? And then just on the second part, from a rose prospective is when you anticipate the reengaging the spine market with the robotic application?
Bryan Hanson:
I'll start with that one first. The goal would be to have a limited launch either right at the time or just right behind the rose in the application for spine. So spine would follow directly the rose in the application. And when we define limited launch, we don't get into specifics about how many robotic systems, what kind of revenue are we talking about in limited launch, the whole idea behind limited launch is to learn. Particularly, when we’re talking about a robotic system, we want to roll this out in a safe and effective manner. We want to make sure that we have the right train that goes along with it and want to learn as we go. Are there any mishaps associated with product launch that we have and if so how do we correct those one a go forward basis. That usually takes us 5 to 6 months. And that's what we would expect probably that the further out piece of that and we’re talking about the robotic systems plus about six months post the time that we limited launch. And to me again, I like to concentrate on individual products because they are important, and certainly when we talk about robotics indeed it is an important area for us. But most important for me is to have that full portfolio that allows us to go on full offence. And to have a robotics platform that complements what I truly believe that the best knee system in the marketplace allows us now some differentiation versus everybody else. The others may have a robotic system but they certainly don't have the Persona Knee System that we have with a personalized capability that brings to the table. And it also differentiates us because with robotics and the segmentation we had in these kind of good, better, best also provides us with some differentiation at that time because much of that like to rose the platform. I like that the fact that we're going to have robotics. I think the bigger story is it is a piece of the puzzle that will allow us to be differentiated first to their competition.
Cole Lannum:
Thanks for that. We are coming up at the bottom of the hour. We just got suite one more quick question. And then we're going to call it operator. So last question please.
Operator:
Our final question comes from Jeff Johnson with Baird.
Jeff Johnson:
Bryan, that was hopeful to comment on the timing around the robot. But wondering on fetus just when do you think full launch there when will instrument set has to be built? You don’t talk things like that on that. And then on the revision knee, same question, is about a six month after last year prelim launch that we should expect instruments that the kind of the whole commercial launch then on the revision as well?
Bryan Hanson:
So on fetus, we're already in full launch. We've entered full launch. And again as that been out -- I've been lucky enough to be with a couple of really exceptional shoulder surgeons and have seen shoulder procedures. I have not yet seen a fetus procedure. But I just got the offer last night from the surgeon that I talked to visit his site and see a fetus procedure. But I can tell you that each of the shoulder surgeons that I spent time within the operating room, are excited about the technology. So we're in full launch and it is being accepted well. As far as revision goes, again, as group referenced, we're looking at a limited launch at the end of the year. I would give that same timeline when we build-up our capabilities to go in the full launch, learning as much as we can, build the supply that we need to be able to go to full launch and that would be towards the middle of 2019. And I would say again, the folks that have seen the revision system really I like it. We haven't gone in limited launch yet, but people have had exposure to it and the exposure to that system is governing very positive responses. And remember, when we do launch revision, it's an important category for us that product is important product for us. But ultimately there are folks that are sitting on the side line that would likely use persona but are waiting for a revision system, so not just the importance of launch in revision, but it's also getting some of the folks on the sideline into the Persona again.
Cole Lannum:
And we're going to wrap it with that. Really appreciate the vast majority of you -- keeping to the one question on the call. We got through bunch of you and I hope this has been helpful. Really appreciate you joining us on the call. A replay of the call will be available later today on our website. And of course the IR team will be available throughout the day to answer any follow-up questions you may have. Have a great Friday and a great weekend. Take care. Bye-bye.
Operator:
Thank you, again, for participating in today's conference call. You may now disconnect.
Executives:
Cole Lannum - Senior Vice President of Investor Relations, IRO Bryan Hanson - President and CEO Dan Florin - CFO
Analysts:
Isaac Ro - Goldman Sachs Amit Hazan - Citigroup Glenn Novarro - RBC Capital Markets Kristen Stewart - Deutsche Bank Larry Keusch - Raymond James David Lewis - Morgan Stanley Bob Hopkins - Bank of America Matthew O'Brien - Piper Jaffray Larry Biegelsen - Wells Fargo Richard Newitter - Leerink Partners Robbie Marcus - JPMorgan Joanne Wuensch - BMO Capital Markets Vijay Kumar - Evercore ISI Raj Denhoy - Jefferies
Operator:
Good morning, ladies and gentlemen. And Welcome to Zimmer Biomet First Quarter 2018 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today, April 26, 2018. Following today's presentation there will be a question-and-answer session. At this time, all participants are in listen-only mode. [Operator Instructions] I would now like to turn the conference over to Cole Lannum, Senior Vice President of Investor Relations and IRO. Please go ahead, sir.
Cole Lannum:
Thank you and good morning. Welcome to Zimmer Biomet's First Quarter Earnings Conference Call. Joining me today is our President and CEO, Bryan Hanson as well as our CFO, Dan Florin. Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please note that we assume no obligation to update these forward-looking statements even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties, in addition to the inherent limitations of such forward-looking statements. Also, the discussions during this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included within the earnings release found on our website zimmerbiomet.com. In addition to the earnings release issued this morning, we have posted a quarterly presentation on our website to supplement the content we'll be covering on this morning's call. With that, I'll now turn the call over Bryan. Bryan?
Bryan Hanson:
Thanks, Cole, and thanks to everyone for joining us on the call this morning. Since joining Zimmer Biomet, one of my highest priorities has been keeping a robust dialogue with all of our key stakeholders. That's why I've spoken with roughly 5,000 of our global team members through a number of valuable forums, including meeting with almost 20% of our regional distributors in the field. In addition, I've had pleasure of sitting down individually with more than hundreds of our surgeons and other customers around the globe. These discussions have highlighted our present opportunities, helped to clarify some of our key challenges and have helped to confirm our priorities for 2018. A lot of my takeaways for these interactions have been positive. I feel better, for example, about this daily progress we're making on supply recovery and quality remediation. Though we still have more work to do in these critical areas in order to further mitigate risk. In addition, I'm even more confident in the enthusiasm and commitment of our global teams, including our best in class sales organization, along with the continued commitment that our customers have to Zimmer Biomet. That said, I'm also gaining better clarity on our inefficiencies, as well as a much deeper understanding of where the organization needs to improve. Some examples of this include gaps in our demand planning, portfolio management and resource allocation processes, as well as a lack of manufacturing automation. Addressing these and other areas of potential improvement represent a critical priority for the entire Zimmer Biomet team. Based on all the input I've received over the past four months, it's clear to me that Zimmer Biomet is well positioned to move back into positive market share growth. That said, it's also clear to me that this will likely be a two year turnaround. As an organization, we will define success in this process is consistently delivering topline growth at market rates or better with the ability to expand margins commensurate with that growth rate. We believe our end markets are currently growing at approximately 3%. My interactions with our stakeholders have also highlighted their capability gaps we need to address within the organization. I've raised this important issue with the board on behalf of the entire leadership team to ensure Zimmer Biomet has the right capabilities in place at all levels of the company. To that end, I'd like to discuss some of the recent additions and changes I've made to the leadership team since I joined. Since I'm sitting across Cole right now, I'm going to start with him. We've welcomed Cole Lannum as Senior Vice President of Investor Relations, as I'm sure many of you know. In addition, Ken Tripp recently joined Zimmer Biomet from Cardinal Health and has assumed the role of Senior Vice President of Global Operations and Logistics. I'm also pleased to announce that Rachel Ellingson, the former Head of Strategy for St. Jude, will be joining us as the Senior Vice President of Strategy. I've also been augmenting our reporting structure to encourage a more inclusive and responsive organization that is more deeply in tune with the needs of the business. Consequently, the following individuals now report directly to me. Aure Bruneau, who is Group President of our Spine and CMF businesses, Pedro Malha, who is the Group Division Head of our Dental business, and Angela Main, our Chief Ethics and Compliance Officer. I'm excited about the changes we've made over the past four months, and I will continue to focus on ensuring that we have the right capabilities and leadership in place. I would now like to provide you with an update a number of the priority areas I've outlined in our fourth quarter call. These include enhancing Zimmer Biomet's culture, our ongoing quality remediation, our supply recovery efforts, new product launches to complete our portfolio and our investments to drive growth. Turning first to our culture building efforts. We want to ensure that Zimmer Biomet is and will continue to be a great place for our team members to work. We have, therefore, continued to conduct a strong cadence of engagement activities over the course of the first quarter, which will positively impact both our corporate teams, as well as our global sales organization. As an example, during the quarter, we redrafted the company's mission and guiding principles, which define our collective goals and values as a combined company. These will be rolled out to our entire global organization as part of our ongoing efforts to drive stronger culture of one Zimmer Biomet. As part of that effort, during the first quarter we conducted a comprehensive workforce survey to give us insight into how we performed in many areas of employee engagement. This information will allow us to focus our attention on areas that matter most to the organization, and importantly because we want to be a metric-driven organization in everything we do, this will provide a baseline to ensure the actions we take are actually improving engagement. We recognize that building a cohesive company with winning culture is a continuous process, and we are committed to receiving feedback and taking action to improve in this area. On the quality front, while we don't usually provide this level of detail regarding FDA inspections at our manufacturing sites, I can confirm that earlier this week the FDA concluded an inspection at our Warsaw North Campus. By way of background, the FDA last inspected this facility in late 2016 and we're currently in the process of executing against our approximately two year remediation plan. As a result, we were expecting the FDA to conduct this re-inspection to evaluate the progress we're making in addressing these previous From 483 observations. In this latest inspection, the FDA issued additional observations and will submit our formal response over the coming weeks. As part of our ongoing quality remediation efforts at the Warsaw North Campus, we'll focus intently on addressing these new observations. This latest inspection confirmed that quality remediation progress has been made, but we still have work to complete, and we're obviously, not satisfied with the current state of our quality system at the Warsaw North facility. Unfortunately, there is no quick fix, but our team is working tirelessly to make the necessary improvements. We take these matters very seriously and remain fully committed to the comprehensive quality remediation effort at the Warsaw North site and we'll continue to keep the FDA updated on our progress. This will remain a top priority for the company. In the areas of supply recovery, we remain focused on restoring appropriate supply of key brands within our knee, hip and S.E.T. categories. Our operations teams continue to increase production levels of these brands and we remain confident that we have the right activities in place. At this time, we believe we're still on track with our goal of restoring supply in substantially all of our key brands by the beginning of the third quarter. On our fourth quarter call, I commented that I believe these supply recovery milestones represented more risk than opportunity. Sitting here today, I'm more confident in that time line that we do need to continue to execute at a high level. As I monitor our progress, my confidence comes from three important factors. First, our supply recovery efforts have continued on-schedule and without interruption over the past quarter second. Second, we've also de-risked some of our key recovery milestones as time has progressed. And finally, we will benefit from the recent additions of high level leadership and operations. That said, there's still a number of critical risk elements we absolutely need to manage. These include ensuring we receive consistent volumes from external automated suppliers in the second quarter and beyond, continued talent retention and stability at our Warsaw North Campus facility and very importantly, successfully executing our ongoing quality remediation plan at the Warsaw North Campus, including fully addressing all observations from the FDA inspections. In summary, on a supply momentum [ph] thus far and my confidence level is higher than a quarter ago, but we clearly still have risk and have to sustain our intense effort. In the area of new product innovation, we have been focused on addressing gaps in our portfolio with products such as the Persona Partial Knee, the Persona TM Tibia Knee and the Persona Revision Knee. Earlier this month, we are also pleased to receive the FDA clearance of the next generation ROSA robotics Brain application. This clearance represents the first in a series of regulatory and commercial milestones in the rollout of the ROSA robotics portfolio, including a total knee application we plan to introduce via a limited launch by the end of this year. Additionally, in the important shoulder reconstructive space, during the quarter, we announced the first surgical case utilizing our recently FDA cleared Comprehensive Augmented Baseplate. In addition to the first U.S. surgery utilizing our Sidus Stem-Free Shoulder. We have been receiving positive feedback on the products we have already launched and we are confident that the commercial introductions plan for the second half of the year will be drivers of future growth. And at this time, absent any unexpected development, we believe we are on pace to meet our time to market projections for those products. As a reminder, we do not expect to have full launch of these products, including the Persona Revision Knee and the ROSA Total Knee Application until mid 2019. At which time, our sales team should be able to truly go on offence. Finally, we have mentioned to you before, we have taken proceeds from the U.S. tax reform legislation and have begun making investments into areas that will drive growth in the business. Generally these investments fall into two major categories. First, we have made specific investments in R&D, both in terms of new product development, as well as enhancements to the commercialization efforts of new product launching this year. The second area of investment is in the commercial organization, where we continue to invest in the expansion and specialization of our sales channel. Clearly there is still a lot of hard work in front of the Zimmer Biomet team, but I am very proud of the team's efforts to date and its daily progress that we have made in executing against our key priorities thus far. In a moment Dan will review our first quarter results, as well as our full year 2018 financial guidance. Broadly speaking, I want to emphasize that although we are currently seeing negative year-over-year sales growth, we do expect to accelerate our topline performance to market growth rates or better over the next 18 to 24 months. We will continue taking the necessary actions to close our gap to market and drive sustained shareholder value. Again, this include successfully driving our ongoing quality remediation efforts, restoring the supply of impacted products, equipping our sales force with a new products to get back on the offensive and executing on our ongoing investments to drive revenue growth. Now I'm going to turn the call over to Dan. Dan?
Dan Florin:
Thank you, Bryan. Net sales totaled $218 [ph] billion in the first quarter, an increase of 2.3% over the prior year period, with a decrease of 1.5% on a constant currency basis. These results reflect the impact of one less billing day in the quarter. On a similar basis, in the Asia Pacific region, we increased sales by 2.6%, while our America sales decreased by 2% and our Europe, Middle East and Africa sales decreased by 3%. As expected, our adjusted gross profit margin came in at 72%, which was 320 basis points lower than the prior year period due to continued incremental manufacturing and inventory costs primarily at our Warsaw North Campus facility, as well as the impact of price declines and the negative year-over-year impact of foreign currency. In the quarter, we recorded pretax charges of $267 million in special items, which included approximately $100 million of cash outflows for quality remediation, business integration and other items. The non-cash charges primarily related to intangible amortization. Our diluted earnings per share for the quarter were $0.85. Adjusted first quarter 2018 figures in the earnings release exclude the impact of the special items that I previously mentioned. Our adjusted operating profit in the quarter amounted to $572 million or 28.3% of sales. Our adjusted effective tax rate for the quarter was 20%. Adjusted diluted earnings per share for the quarter were $1.91 on 204.6 million weighted average fully diluted shares outstanding. A reconciliation of reported net earnings to adjusted net earnings is included in this morning's press release. Operating cash flow for the quarter amounted to $490 million, inclusive of the previously mentioned cash special items and our free cash flow was $403 million. Free cash flow exceeded our expectation, primarily due to the timing of certain capital expenditures and accounts receivable collections. Please note that in March, we borrowed $400 million under our revolving credit facility and issued $750 million of senior notes. The $1.150 billion in proceeds were used to repay senior notes on April 2. Due to the timing of these events, we have temporarily higher-than-normal cash and debt balances as of March 31. Our net debt of approximately $9.3 billion at March 31st is approximately $270 million lower than December 31, 2017. I'd like to now turn to 2018 guidance. In our press release this morning, we highlighted a number of guidance items, which should help you and your modeling as you think through 2018 and beyond. We expect full year reported sales to increase between 1.5% and 3.5%. Note that these numbers include a positive impact from foreign exchange of between 200 and 300 basis points, which will be more favorable in the first half of the year compared to the second half. Excluding the impact of foreign exchange, we expect our operational growth to be approximately flat, turning slightly positive in the back half of the year. Looking at profitability, we expect operating margin to be between 27.5% and 28.5%. It is important to note that while we are pleased with the progress we are making in the consistency and volume of production from our Warsaw North Campus facility, we continue to incur increased levels of manufacturing and quality cost in that plant. As a reminder, a significant amount of these costs become capitalized into the inventory base and released to the P&L as that inventory is sold, meaning that the gross margin headwind will continue for about a year after those costs are incurred. Further, over the past 18 months, the operations team has been solely focused on quality remediation and supply recovery and not focused on driving productivity initiatives. Other items impacting our operating margins include the growth investments funded by U.S. tax reform and the incremental expense from our incentive compensation programs compared to the prior year. It is important that you take these items into account as you model 2018 and beyond. We expect our adjusted tax rate to be between 18.5% and 19.5% for 2018, and we expect adjusted diluted earnings per share to come in between $7.67 and $7.80 per share. For 2018, we expect free cash flow generation to come in between $1.1 billion and $1.3 billion with the majority of that being used for debt repayment in 2018. As you think about your models, I want to help you with a couple more items. You should expect interest expense to come in at approximately $300 million, significantly below last year as we are benefiting from the continued reduction in our debt levels. In addition, weighted average fully diluted shares outstanding should be slightly above the average levels you see in the first quarter. To summarize, our focus in 2018 is on continued progress and quality remediation and supply recovery, as well as launching several key new products and investing in programs to drive topline growth. While our operating margin is pressured this year for the reasons I've outlined, we expect modest margin expansion in 2019 and we are committed to further expansion in the future as our topline accelerates. With that, I'll turn the call back to Bryan.
Bryan Hanson:
Thanks, Dan. While our first quarter performance continues to reflect supply related headwinds, as well as our ongoing quality remediation work, we remain deeply confident in the foundation of our business. And while there is some ongoing risk and much work remains to be done, we continue to be pleased with the steady progress we are making in these areas. With that, I'll turn the call back to Cole, who will take us into Q&A.
Cole Lannum:
Thanks, Bryan. Before the Q&A session, I would remind you to please limit yourself to a single question with a brief follow up if needed. Feel free to put yourself back in the queue if you have further questions and that will us to get to as many people as possible. With that, operator, may we please have the first question?
Operator:
Thank you, sir. [Operator Instructions] Our first question comes from Isaac Ro with Goldman Sachs.
Isaac Ro:
Good morning, guys. And thank you. Wanted to focus on the gross margin commentary, could you give us a sense of trajectory, you know, your prior quarter guidance had called for, I think, 72% to 73%. You're at the low end of the range of that prior guidance range this quarter. Should we expect the gross margin trajectory to decline as the year progresses, because I just want to make sure we reconcile that to score up with the EPS guidance that you just gave us? Thank you.
Dan Florin:
Sure, Isaac. So in January, we did give a range of 72% to 73% on the gross margin. So today, while we're not providing specific gross margin guidance, we did provide guidance on operating margins, which does provide some indication that the gross margin rate remains under pressure throughout 2019 and that's really due to two factors, as I said on the prepared remarks. The first one is we've been incurring the elevated production costs in the North Campus since early 2017, and these elevated costs will continue through this year even after supply is fully recovered. These costs are capitalized into the inventory base and flow through the P&L as the inventory is sold. So we began seeing these costs in the P&L in the second half of 2017 and will continue through this year and also into next year. The second element is the lack of productivity initiatives that I described, so we're not getting any offset against pricing declines, for example. So those headwinds will continue through the year and I think that it's fair to assume that the gross margin will stay under pressure relative to the - what we posted in Q1.
Isaac Ro:
Okay. I understood. Thank you.
Cole Lannum:
Thanks, Isaac. Next question please.
Operator:
Our next question comes from Amit Hazan with Citigroup.
Amit Hazan:
Great. Thanks, good morning. So just curious what's your assessment of the U.S. hip and knee market in the quarter? So far I realized not everyone has reported, but just in terms of growth and more importantly what are you assuming for U.S. market growth in hips and knees in your 2018 guidance? Thanks.
Dan Florin:
Sure, Amit. This is Dan. So consistent with our expectations based on what we've seen from one competitor and ourselves, we believe the U.S. large joint market decelerated by about 100 basis points relative to the Q4 growth rate. Of course, we won't know the full market model until everybody reports. I would characterize it as the U.S. market was down a bit more than we expected. The U.S. hip market declined a little less than expected, but in the aggregate about what we expected. So we pegged the U.S. hip and knee market about 1% during Q1 compared to just over 2% in Q4. I think that it's important not to get too concerned about quarterly fluctuations. If you look over the past three years the U.S. knee market has average about 3% growth and the hip market about 2% growth. So nothing in Q1 surprised us and we continue to view the market as quite stable.
Amit Hazan:
So just to confirm then on that second part…
Dan Florin:
Go ahead.
Amit Hazan:
Yeah, on the second part of my question then, are those the growth rates that you're assuming for the year basically in your guidance. Is it the last three year trend?
Dan Florin:
At this point, Amit, we're assuming similar growth rates to what was seen in 2017.
Amit Hazan:
Thanks.
Cole Lannum:
Thanks, Amit. Next question please.
Operator:
We'll take our next question from Glenn Novarro with RBC Capital Markets.
Glenn Novarro:
Hi, thanks. Good morning, guys. Bryan, can you provide a little bit more color on the new 483 observations at the North Campus received. And do these new observations in any way impact the supply recovery that sounds like you're still on track to get back to normal by the beginning of 3Q? Thanks.
Bryan Hanson:
Yeah. I mean, no problem, Glenn. So first of all, what I would say is I doing want to get into obviously too much detail relative to the 483s. But I will tell you this. Obviously, this is brand new. We just got the outcome this week, so this is hard off [ph] to press. And we're still working through the information where we see from the FDA. And believe, we're not just looking at this internally, we also have our external advisers taking a look at it with us as well. But what we know now, based on what we see today, we obviously felt comfortable giving you the FY '18 guidance that we just gave you. And inside of that guidance, obviously, we have some assumptions around when we're going to see supply recovery and we feel comfortable with those. That said, I think this is really important that I say this, you know, for us the primary focus will always be patient safety. If at any time, we think that we're putting patients at risk, which, obviously we don't, but if we do, that we're going to take the right actions to make sure we take care of those patients. I do want to just maybe take a second though and just pull up a little bit. When I think about our FY '18 guidance and really the color we're putting in place for 2019, it's not just quality remediation, it's a variable. That is clearly one of the variables we considered, but it's also just supply recovery for any reason. Timely product launches that we need to have and get those to scale, which we define as full launch is very important. And I really do believe we're going to need to see a shift in the culture and the engagement of this organization. So just no, it's not just the quality remediation we're taking into account. All of those variables, risks and opportunities and that really has what guided us through the guidance we just gave you.
Glenn Novarro:
And can you just as a follow-up, can you give us at least a number of observations you received. Were they less than the last time, any additional color? Thanks.
Bryan Hanson:
I think the only the color I'd provide is really we want to work through these and keep in mind it's fresh. It is less than the previous time the FDA was in. But to me it doesn't matter, In fact is we have observation, at any level of observations I want to take them extremely seriously. We don't mess around when it comes to quality. Any observation is not a good thing, and we are going to tackle it as aggressively as we would even if that was more. It doesn't matter if it's less or not to me, I want to tackle these things extremely aggressively.
Glenn Novarro:
Okay. Great. Thanks, Bryan.
Cole Lannum:
Thanks, Glenn. Next question please.
Operator:
Our next question comes from Kristen Stewart with Deutsche Bank.
Kristen Stewart:
Hi. Thanks for taking my question and thanks for the updated schedules within the press release, they are really helpful. I just wanted to touch on some of the color that you had from the 2019 comments. I want to make sure I understand those correctly. So if I'm hearing you are right, we should continue to see gross margin pressure extending into 2019 as some of the capitalized costs are realized through the P&L. And then you had also commented, I believe that you do expect to see some operating margin expansion. So maybe just touch on how much - how you're thinking about the reinvestments there and the commitment towards seeing operating margin expansion in 2019? Thanks.
Dan Florin:
Kristen, this is Dan. So we're obviously not giving guidance here for 2019, I want to make that quite clear. But I do think it's fair to assume that cost of goods productivity is not a driver of operating margin expansion in 2019 for the reasons that I described. So the drivers of modest operating margin expansion as we think about them today really starts with acceleration and sales growth, particularly our expectation that U.S. sales growth would accelerate. And with that sales growth acceleration we would expect to see some favorable product mix impacting gross margin. We also expect while we're making the investments here in 2018 that will start to bear fruit on the topline and we should be able to drive slight SG&A leverage without hurting our ability to invest into the business for growth. So given the potential of modest operating margin expansion, some financial leverage, I would tell you that we would be disappointed if we didn't have some amount of earnings per share growth in 2019.
Bryan Hanson:
And Kristen remember too though part of the message today on 2018 for which we are giving guidance is that those operating margins need to come down from where the street is right now. Once the street gets those into the appropriate realm, that's based off of which Dan is talking about we think we're going to expand.
Kristen Stewart:
Okay. That's helpful. I'll jump back in the queue.
Cole Lannum:
Thank you very much Kristen. Next question please.
Operator:
We'll take our next question from Larry Keusch with Raymond James.
Larry Keusch:
Okay. Thanks. Good morning, everyone. Bryan, you mentioned in your prepared comments that you've been out on the road meeting stakeholders. I guess I just wanted to get some impressions of sort of what you're hearing from customers you indicated you met with surgeons. And I guess, along with that, how do you set the sales force morale and retention at this point and things that needs to be done to make sure that, that organization stays in place?
Bryan Hanson:
Yeah. I'd say - I've been really pleased with the amount of connections that I have been able to make in a relatively short period of time, not just with the customer base and surgeons, but also with the commercial teams as I've already referenced. And I got to say, of course, it could be who my sales organization is spending to, but the surgeons that I'm talking to and there is been quite a few of them as I mentioned feel very confident about our business. They are frustrated that we're in our own way, obviously. But there's a real commitment to this business. There is a real sense that we do have the right product portfolio as we've combined Zimmer and Biomet with the new products coming as well. So I get this real desire to seize Zimmer Biomet win in a real comfort level and confidence in the product that we already have. So that's what I'm feeling from the surgeon customer base. I don't want to diminish the fact that we're disappointing them, and we are, and I hear about that as well. But what my general sense is that people are committed to us, and we are not seeing more churn than we would typically see from our surgeons. Now we're also not on the offense because we have the product supply issues, so even though we're not losing as many more surgeons than we typically would, we're also not feeling the funnel with new surgeons because we're not in the offense. So I just want to be pretty clear on that. From a sales perspective, I'd say just a fact that I've been in the field around the world visiting with our either direct reps or distributor reps, there is a comfort level that I'm going to be paying attention in the senior leadership team, as a result of that will be paying attention to them. And even just that attention alone seems to have an extra skip in the step of the commercial organization. And I do get a lot of emails, a lot of text messages when the folks that I talked to, they are saying that they are energized more than they have been in the past. I also do believe from our retention standpoint, we're so close now to supplier recovery. We're so close now to this new culture that we want to bring to Zimmer Biomet. It would be crazy for people that have hung this long to leave now. So that's just my general feeling on it.
Larry Keusch:
Okay, great. Thanks very much. I appreciate the thought.
Bryan Hanson:
No problem, Larry.
Cole Lannum:
Thank you, Larry. Next question please.
Operator:
The next question comes from David Lewis with Morgan Stanley.
David Lewis:
Good morning. I got two related questions, both kind of around cost and levers. The first thing is for Dan, the second for Bryan. So Dan, for us today the single best biggest incremental information, sort of incremental investment, I wonder if you just talk about what's new over the last three months from either the operating investments or reinvestment of the business and non-GAAP spending and sort of the pacing of the next several quarters? And then for Bryan, thinking about the profile this business, I think your commentary base suggest you get back to market growth around 3% by 2020, 18 to 24 months from now. When you get there, what's the commitment to leverage earnings for this business? What's your philosophy around leverage earnings and what investors can expect? Thanks so much.
Dan Florin:
Okay, David. First on the investments, so I think you're referring to taking the benefit of tax reform and reinvesting in the business. So, really two categories of investments, and I can tell you that there's really not much of that in the Q1 results. So part of the margin, the operating margin pressure on the back half is because we're investing above the line, but we're getting our benefit below the line. And the investments in the business, as Bryan said in his prepared remarks, our focus really in two areas. The new products, so both products that are in the pipeline, as well as the new products that we're launching and making sure that we get the full value as we launch those new products. And then the second investment is in the commercial organization. And for competitive reasons, we're not going to get into the specifics of what those investments are, but just know that we're going to invest in the commercial channel. I think the second part of your question really has to do with the cost of goods and as I described before, we continue to incur those elevated costs in the North Campus. Those began in 2017. And as I said in my prepared remarks, that will continue to be a drag in the P&L through next year. And it is not the case that one supply is fully restored, as those costs go away. I think it's important to people understand these are mainly variable cost to produce parts out of the North Campus. And those variable costs are elevated because of what we had to do in terms of interim process controls and additional inspection because of the 483s. So those costs are there in the North Campus, and over time, we're going to drive productivity initiatives. Certainly, the addition of key operations talent from Ken Tripp who has a track record of delivering productivity across the network, and be very focused on that. The first and foremost, of course, is quality remediation and supplier recovery.
Bryan Hanson:
And I think on that just - kind of draft of what Dan just said. Just recognize that when supply recovery occurs, it doesn't mean that we get an immediate drop in cost in Warsaw, I just want to make sure if that's clear because to continue to operate in Warsaw in any way, shape or reform even when supply recovery is in place is still going to be elevated. As we said, we're going to get to tackling those costs and reducing them but because of the capitalization, you don't get full effect of those cost reductions for 12 months. But we will be something we're absolutely going to be concentrating on, but I just want to make sure it's clear. Those elevated costs don't go away just because of supply recovery happens. So David, on your second question, I just want to be clear, absolutely. I mean, we're in the game to drive leverage in the P&L. At the end of the day, we have aspirations to be a top quartile performer and total shareholder return. And to do that, you've got to have revenue growth for a certain level and you absolutely got to be able to tie leverage in the P&L. That will be a focus for the organization. I do want to make sure that I provide some clarity though around - when I talk about 18 to 24 month turnaround, what does that mean? I think first and foremost, is I've already said, it means we will consistently, I think, consistently is a really important word here, deliver growth rates at or above the market that we're playing. Our weighted average market growth, we say right now is about 3%. Now to me consistently means I want to do it for the full year. So 2020 is that fiscal year that I feel we're going to get that accomplished. Two things kind of inside of that that I think are really important takeaway. First one is, if everything goes right and our job as leadership team is to try to make sure it goes right, we will absolutely have the opportunity to have quarters before 2020 at or above market growth. I just wouldn't consider that consistently until we get it for full year and I think that first full year, as I said, is 2020. I also want to say that once we do these short term things to stabilize the business, I want to quickly get to active portfolio management. Hiring Rachel is the first step in that direction, but believe me, it is high on my mind, I'm not a very patient person around the type of thing. So I don't want to make sure that we get to active portfolio management with the intent of acquiring businesses or potentially divesting businesses that will allow us to increase our weighted average market growth. First and foremost, those decisions have to be supportive of our mission, they have to - need all the financial metrics that we have, but we're going to be very focused on increasing the weighted average market growth of this business. So you can think about what I would say for sure, if we do the things that I want to do that 18 months to 24 months from now, the portfolio will not look the same. And guaranteed one can assume that the moves that we make will increase our weighted average market growth and give us the potential to grow above 3% when we do that turnaround. So I just wanted make sure I am very clear on that, that we've got the remediation stuff done, we've got to make sure that we get in place, but portfolio activity will be something we're going to be concentrating on.
Cole Lannum:
Thanks, David. Next question please, operator?
Operator:
We'll take our next question from Bob Hopkins with Bank of America.
Bob Hopkins:
Thanks very much for taking the question and good morning. So I've got two questions. First, Bryan, sorry to harp on this, but I just wonder if you could explain a little bit more detail why you are confident the supply will be coming back beginning of third quarter despite the fact that you're talking today about additional FDA observations in the North Campus? Just what specifically increases your confidence?
Bryan Hanson:
Yes, Good to talk to you, Bob. I would say, let me think if I am half ready, I absolutely feel more confident than a quarter ago and I'm really trying to gauge what I'm saying here versus the last time that I talked to everybody publicly on this. I do feel more confident, and there is basic reasons why and it sounds simple. But every day that goes by that we don't have a mishap [ph] in the facility, it takes us off our schedule. And I'm going to say a material mishap because it happens all the time. But if we don't have a material mishap that gives me more confidence that we're moving in the right direction. And just to put this into context, face value, every day that goes by that we don't have an issue, we burn down risk associated with the project time line, with the complexity of the project. And so just getting through the days without an issue burns down risk just by the very nature of moving through time because it reduces the complexity of the project and it gets us through these major project milestones. I also feel and not that it has happened yet, because it's brand new, but I also feel that having key talent like Ken Tripp and the other people that will be coming into the organization is going to help us in this area. And I would say not just with supply recovery, but I also think that as was mentioned before, really moving to that next phase, which is a very disciplined approach to removing costs from the entire footprint that we have in operations. We need to see that. Now unfortunately, as we've already referenced, once you get to the point, there is a delay in realizing that benefit because the way it was capitalized. But the fact is we got to get moving. And so that new talent is going to help us with stabilization, but also get to the point we start to cost reduce. And I would say this inside as well, I'm very pleased that Adrian Furey who was running operations with us before is staying with the organization. This is big win. Ken Tripp coming in, Adrian's moving with his family after an [indiscernible] back to Ireland. He's staying at a high level position within the organization with all the brainpower and capability that he has that is a big win for the organization. Now the risk to this, right on the supply recovery piece and which you're calling out is not done yet, right. We've gotten the external suppliers moving. We've gotten through B&Bs. Remember before I was very worried about the process, the zero process of B&B, we're through that. But I still need to see consistent volumes coming from those automated suppliers. And so far they are there, but every month that goes by that we have those, my confidence level grows. We've stabilized the workforce in Warsaw. But I'd say right now, we can't take our eye off the ball. Crazy as it sounds, this is a very difficult place to hang on the talent, the talent war in Warsaw is real and we need to make sure that we keep our eye on the ball and continue to keep folks in that factory. And you just mentioned, the biggest thing that we've got to keep an eye on here is quality remediation. And although we're making progress, we're absolutely not there yet. The fact that we got additional observations tells us that. So we need to be very vigilant in absorbing what the FDA has given us, ensure that we get on top of it and remediate. But that is a single biggest risk at this point, obviously, supply recovery. So I feel better about our position, there's no question about it, but I'm absolutely not naive around the risk that is still in front of us.
Bob Hopkins:
Very helpful. Thank you so much for the detailed response. And then one quick product question as a follow-up, can you just talk a little about what happened to hips in EMEA this quarter and maybe a little bit on the shoulder launch side. Hips in EMEA seemed to be a little light, just - was there anything particular going on there?
Bryan Hanson:
Not really, to be honest with you. As we have mentioned before, we thought we'd see a little bit of lightness in the U.K. That came to fruition. In general, we feel pretty confident. The fact is whenever we see after the first quarter and beyond is built into the FY '18 guidance we just gave. So our confidence level in the EMEA business is still there.
Bob Hopkins:
Great. Thank you very much.
Cole Lannum:
Thanks Bob. Next question please?
Operator:
Our next question comes from Matthew O'Brien with Piper Jaffray.
Matthew O'Brien:
Good morning. Thanks for taking the question. I'll ask both together, primary and then a follow up together here. So first of all, on the revenue guidance for the year, you just came off of your toughest comp of the year. And then as I look at the rest of the year on a two year stack basis, you're actually assuming things get even worse than what you saw here in Q1 constant currency. Can you help us understand why that would get worse, given the new launches, et cetera? Are you just trying to ultra conservative, is there something on the sales force side that we need to be paying attention to? And then as a follow-up, Bryan, you mentioned portfolio management given your background, bringing somebody from St. Jude, are you interested in going outside of the traditional musculoskeletal space as Zimmer Biomet has really focused on historically? Thank you.
Dan Florin:
Matt, I'll take the first one. So first with respect to the constant currency revenue trajectory, in Q1, we had the billing day impact which was just over 100 basis points. So embedded in our guidance is some acceleration on a constant currency basis as we progress through the year. I mentioned back half of the year turning positive. I think the main issue there as we talked about before is as the supply gets healthy in July, you know, that delayed effect of revenue acceleration. So our guidance assumes full supply by July, the impact of - a delayed impact of revenue acceleration and continued momentum in hips and then we get the cementless [ph] benefit as well. So there is - our expectation is acceleration in the back half of the year. It is quite modest because of that delayed acceleration. Just know that we're driving hard to continue to outperform that, but we feel good about how the year is set up.
Bryan Hanson:
I just want to just comment on that too. You mentioned is it just conservative, we really don't believe that. We think it properly balances the risk and reward that we have as we move into the back half. Dan is 100% right, the more that I travel with our sales reps, I can definitively tell you, there is a lack of trust even with me and they feel connected to whatever may be. There is a lack of trust what we say relative to supply recovery. And there is kind of objectivity and subjectivity. So objectively, we're improving array and we get supply recovery. We're going to be objectively be there. Subjectively, any slight miss that we've been normal course of businesses in supply is going to be exacerbated in mind of sales representatives, they're going to slow down. So this risk of delay in driving revenue once the supply recovery comes is absolutely real. I've seen it every time we're talking to sales reps, just want to make sure that you hear that for me. On the portfolio management side, here is my thoughts on this and I'll let train if it goes through here. We are going to do two things. Number one, we're going to concentrate on getting deeper position in areas that we already play that happen to be a more attractive from a market growth perspective, where we think we can bring value, and where we think we can bring value So there's no question we're going to double down on areas we're already in, that are more attractive from the market growth standpoint and continue to increase our position there. But we will certainly look at if the opportunities are right and if I feel the mission will hit the financial metrics areas that are outside of the spaces that we play to diversify business and bring our weighted average market growth rate up. I'm not solely committed to either one of those, we will do both.
Cole Lannum:
Thanks Matt. Next question please.
Operator:
Our next question comes from Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
Good morning. Thanks for taking the question. So Bryan, I wanted to focus my question on the new product introductions. So you're launching a lot of important new products, I think five to six new ones. So from your perspective, which of the most impactful and why? And I had specific questions on ROSA which the streets obviously hyper-focused on the total EMEA [ph] application. So what's your confidence in the second half 2018 limited launch, what are the steps you need to get there? And I don't think you guys disclosed kind of cutting mechanism. Are you ready to kind of disclose at this point? Thanks for taking the questions.
Bryan Hanson:
No, obviously, I'm not going to provide any more information on ROSA's feature set that Dan already provided for competitive reasons. But I do feel confident right now. I mean, there's nothing that's indicating that we won't get to limited launch by the end of the year. Obviously as I referenced before, with an assumption that we do hit the time line there would be a time lag between that limited launch and full launch which should be more in the mid-'19 time frame. But we're feeling good about where we are in the process. And let's face it, we have some history here. It's not like this is our first robotics system. We had one in the brain, we're going to move into the spine and also in the knee. So there is a theme that is confident in the area and has the history of being able to get products to market on time. So that's specific to ROSA. So just in general, I don't want to pick a specific product out and say this is the most important. I think it is the combination of the products that we have and I kind of think about it when I pull back and give the product development and we spend a lot of money in R&D. We need to be productive with that money. And I first like to look at do we have the right portfolio mix that we're going to bring into market. And I can tell you firsthand, as I've been out talking to our sales reps, as I've been out talking to our customers. I'm hearing directly from them that what's coming in the pipeline is exactly what they're looking at - looking for and we're going to delight our surgeon customers with this, but very importantly we're going to fill the product gaps that we have particularly in the knee space. So when I think about knee I'm very excited about launching things like Partial, cementless, revision, all in Persona family, which I personally believe is the best knee implant in the marketplace. It really does give you an option to personalize the knee size for the patient. And that's just the whole premise behind the technology. So once we round that line out, will not only have the best implant, but we're going to have the full portfolio, particularly when ROSA key application comps. I think the thing that I always wanted to squeeze and pause on is that you know, fact is we're not going to have that full portfolio because I really do think the full portfolio is what's important here, ready to go, fully and offense someday 2019 with an assumption that we had time line that we currently have with product launches. I also don't want to discount the steps we're doing at S.E.T. now our S.E.T. business is a focus for us. So the Comprehensive Baseplate, Sidus Stem-Free Shoulder, jogger stitch in sports I mean, people aren't talking about that. That's an exciting product in sports and other products that we're going to launch, plus the specialization of that of our sales organization is going to be an opportunity for future growth for us as well. So I'm excited about the product launch and activity we have in front of us. I just want to make sure that everybody enthusiasm is properly focused on that kind of mid 2019 as that real offense of goal mode.
Larry Biegelsen:
Thank you.
Cole Lannum:
Thanks. Next question please.
Operator:
We'll take our next question from Richard Newitter with Leerink Partners.
Richard Newitter:
Hi. Thank you. I'm not sure if I missed it, but can you just update us on where you are with the ROSA robot on spine applications and the launch there? And then free cash flow into '19, you talked about earnings growth and some operations and capitalize cost that are going to flow through the P&L and take a little longer to materialize. I guess, we should still though from a free cash flow standpoint, see some acceleration ahead of that kind of leverage to earnings growth. Is that the right way to think about it? And can 2019 be a meaningful free cash flow, kind of acceleration here? Thanks.
Dan Florin:
Rich, let me take the free cash flow question first. So as I said, the guide for 2018 free cash flow is between $1.1 billion and $1.3 billion and our intention today is to use the majority of that to pay down debt. With that, what it will enable us to do is take our leverage ratio down from the year-end 2017 level. Looking beyond 2018, our financial flexibility will increase as we continue to make progress and our free cash flow yield, particularly in the back half of 2019 and certainly, into the 2020, just based on earnings growth, but also based on a decrease in cash special. So for example in 2017, our cash flows were about $0.5 billion. That comes down slightly in 2018 and then we expect that to come down even further in 2019. So I'd say the combination of earnings growth, better working capital management, we're already seeing that in the accounts receivable side and then a reduction in cash special, it's a combination of all that will increase our free cash flow yield.
Bryan Hanson:
Great. And on the second question relative to the spine application of ROSA. First of all, you should think about it. What I'm excited about is being able to leverage the ROSA platform, not just in brain, not just in spine, but also in knee and potentially other places as well. Knee is important because we're making significant investments in the robotic platform, and we will continue to do that. And as you have applications off of that platform that you can use, there's real value in return invested capital on that. So that excites me. Brain, we just said was proved that activity right now. The community there couldn't wait for that. I'm very excited. It's a relatively small, but it is an important application of the technology. Spine is pretty similar time frame to the knee application that I referenced. We're looking at around fourth quarter where we get limited launch as we move in 2019, will move into full launch and then I already talked about the knee application. But again, I think the key takeaway here is each of these applications we believe will be beneficial in their individual areas with the fact that eventually, we can leverage the same platform for multiple applications is a real benefit.
Richard Newitter:
Thank you.
Cole Lannum:
Thank you. Next question, operator, please.
Operator:
Our next question comes from Robbie Marcus with JPMorgan.
Robbie Marcus:
Great. Thanks for taking the question. Bryan, as I hear your comments about whether or not you have the right portfolio going forward, the two businesses that stand out to me is underperforming are dental and spine. So maybe you could give us your latest thoughts on how the dental business fits in at Zimmer. And then what you're seeing in terms of integration for LDR and spine and your outlook for the 2018 market? Thanks.
Bryan Hanson:
Great. Thanks, Robbie. So first of all, let me just talk about dental. Obviously, when we think about any kind of portfolio moves, I'm sure that you know that we wouldn't talk about anything that's active or even contemplated, so I'm not going to speak specifically about dental as being the target or not being a target for divestiture. I will say just broadly speaking, as I mentioned before, I'm very eager to move into the phase of active portfolio management. Rachel, again, being on the team is a perfect example of my aggressiveness to try to move in that direction. She is fantastic, by the way, if you haven't met her, I'm sure you will meet her over the coming months or a number of you will. Our goal is to move into that active portfolio management and I don't want to give specifics on where we're going to go. But the whole intent is to drive initially the organization forward, is to ensure that we have the financial metrics that we need to jump, make sure we have jump those hurdles. And we need to increase the weighted average market growth of this business, period whether this new divestiture or acquisition with the ultimate goal of driving increased shareholder value. That's really where we are. So I won't say anything more about any specific targets or anything else. Relative to the spine business though, I'm committed to spine, I'm committed to spine. Do I like the performance that we have right now? No. 55:37[Audit Start]Here's what I would say, we have a great new team. I'm not just talking about Lori running that business now collectively spine and CMF and Thoracic. We have a lot of leadership changes that we've seen in spine, all the way down to the sales leadership a number of new people have come in at a senior level of sales that are extremely capable and have a lot of history in spine that I think they're going to bring value. So now not only do we have the right portfolio, I truly believe we have the right team. There's a lot of stuff we need to the right now with channel strategy, typically with the LDR acquisition, we're moving rapidly through that right now and any disruption that we think that will come from that is built into the guidance that we already gave you. But make no mistake, we are committed to spine, we have the right portfolio, we now have the right team, we have opportunity there.
Robbie Marcus:
Thank you.
Cole Lannum:
Fantastic. Thanks. Next question please.
Operator:
Our next question comes from Joanne Wuensch with BMO Capital Markets.
Joanne Wuensch:
Good morning and thank you for taking the question. Can we revert back to S.E.T. a little bit? This strikes me as a business where the end markets are growing faster than hip and knee and yet I would love to understand how you get sort of back to that market growth rate and how much of the pressure that we're seeing right now is products versus sales force versus maybe something else?
Bryan Hanson:
Yes. I mean, what I would say just, specifically is S.E.T., Sports, Extremities, Trauma subcategories of that are very attractive. We want to land on of those areas what are going to be a primary growth engines that we have as a business to make sure that we're doubling down relative to investment. We already see a lot of investment going into those businesses. We're already seeing commercialization changes to be able to specialize, and we are fully committed to driving growth in those more attractive areas. So in don't want to give any more color than that. I don't think that there's any reason at all that in the areas that we concentrate, we can't get market and quite frankly, I don't see - because of our low penetration in those spaces any reason why we can't be above market growth in those areas.
Dan Florin:
Yes, Joanne, I would just add that S.E.T. is a product group that has been impacted by the supply issues out of the North Campus. So inside of that, there's a number of fast-growing key legacy Biomet sports Medicine, Extremities, Trauma products that come out of that facility. The good news is, as Bryan has said, we're restoring to full supply on those products as well and I think that bodes well for the future growth rate. But the end markets are very strong, supply is recovering, we're investing in specialization and good things to come in S.E.T.
Bryan Hanson:
And really, even in certain categories today, growth rate is pretty good.
Dan Florin:
Yeah.
Joanne Wuensch:
As my follow-up, how do you define the market growth rate?
Bryan Hanson:
For S.E.T. you mean?
Joanne Wuensch:
Yes, please. Your hips and knees is 2% to 3%. Is S.E.T. 5% to 6%?
Dan Florin:
Yes. I'd peg it in that 5% to 6%. It's unlike hips and knees given the number of players on S.E.T., it's less precise market model, but that's how we think about it, about 2x the growth rate of large joints.
Joanne Wuensch:
Terrific. Thank you so much.
Dan Florin:
There's certain categories in that, that are even higher, some lower, some higher, but in aggregate, I would agree to that by mid single-digits.
Cole Lannum:
Thanks, Joanne. Operator, we're coming close to the bottom of the hour. We're trying to get two more questions and really quickly if you guys can go fast. So next question, please.
Operator:
We'll take Vijay Kumar with Evercore ISI.
Vijay Kumar:
Thank you guys for squeezing me in. So maybe my two quick ones are, one, may be when you look at the organic growth guidance for the fiscal year, can you comment on the cadence because we had negative 150 bps in Q1 and I believe that has a days impact as well. So should we be thinking about positive organic by Q4 and that offset sort of what we're seeing in Q1? And second assuming the positive organic, that continues into fiscal 2019. Should we be expecting margin expansion in 2019? Thank you.
Dan Florin:
Vijay, with respect to the organic or constant currency growth rate projection for the balance of the year, I did comment that we do expect positive growth in the back half of the year compared to the negative growth in Q1 even on a day adjusted basis. That's the first point. Second point, I commented that we do expect some modest operating margin expansion in 2019. And with that, our expectation is to see some amount of earnings per share growth in 2019 as well.
Vijay Kumar:
Thank you, guys.
Cole Lannum:
Thanks, Vijay. And operator, one last question, please.
Operator:
And we'll take our final question from Raj Denhoy from Jefferies.
Raj Denhoy:
Thank you. Bryan, maybe high-level question for you. As I'm sure you can appreciate the last couple of years is kind of been death by a thousand cuts for investors on Zimmer in terms of the earnings side, right? Now you've given us guidance, $7.60 to $7.80 this year, kind of modest operating margin expansion next year. And so, I guess, what I'm trying to get at is your level of confidence in those numbers, in terms of this the bottom year? Can investors now expect that this is the base upon which are going to build or there's some risk in these numbers?
Bryan Hanson:
Yes. Thanks, Raj, for the question, number one, and good to talk to you on the phone. Here's what we really try to do, this is the reason why we delay giving you guidance until now versus the beginning of the year. We really wanted to take the opportunity to go through all the things that need to happen to be able to get the 2018 guidance to be materialized. And I think even more importantly than that, the things that need to happen to eventually to get to the turnaround that we referenced. And we're trying to be as balanced as we possibly can in that calculus. I mentioned it before, you got to have quality remediation comp, you've got to have supply, can't have slippage on that if you do have slippage it can't be by much you got to translate that into revenue recovery as well. You've got to have new products on time and that scale and you've got to make changes in culture. All those things have variability to them. And we've really try to take into account what level of variability we can have, theI impact those things will have on the business and then give you a balanced view of what we think we can do from a guidance perspective. So it's a level that we can, we've given you what we truly do believe is a realistic view of what this business can do, not just in 2018, but also with the color we've given you in 2019.
Dan Florin:
And Raj, let me add something, I think it's important we try to give you a lot of color on this. On the revenue side, we think people are pretty close, there might be some sequencing issues as Dan discussed on some of his color upfront, it is going to be accelerating throughout the year. We need to get some of the - these things behind us before we'll see some of that acceleration. But the real thing that I think people need to work on and the reason, quite frankly, why the range was below where current consensus is on EPS was on the profitability side and operating margin. I think we've given you a lot of color there, but there are at least some people on the street that are just too optimistic on the operating margin numbers, and they need to come down. Hope that helps.
Raj Denhoy:
That super help. That's helpful. Appreciate. Thank you.
Dan Florin:
Thanks, Raj.
Cole Lannum:
Okay. With that, folks, we're going to wrap up. I just want to say, first of all, I really appreciate the cooperation. We were able to get, by my count, 14 questions in on the call and I appreciate everyone cooperating and then trying to be quick on this, so we can get to as many as possible. From our standpoint, there will be a replay of this call later on today on our website. And if you have any follow-up questions, we will be travelling. But the best way to reach Derek, Bob, and myself is by email, so send us an email throughout the day. Enjoy the rest of your week. Talk to you soon. Bye-bye.
Operator:
Thank you, again, for participating in today's conference call. You may now disconnect.
Executives:
Derek Davis - IR Bryan Hanson - President and CEO Dan Florin - CFO
Analysts:
Mike Weinstein - JPMorgan Bob Hopkins - Bank of America David Lewis - Morgan Stanley Matt Taylor - Barclays Kristen Stewart - Deutsche Bank Joanne Wuensch - BMO Capital Markets Richard Newitter - Leerink Partners
Operator:
Good morning. I would like to turn the call over to Derek Davis, Interim Vice President, Investor Relations. As a reminder, today’s call is being recorded. Mr. Davis, you may begin your call.
Derek Davis:
Thank you and good morning. Welcome to Zimmer Biomet’s Fourth Quarter and Full Year 2017 Earnings Conference Call. Joining me today is our President and CEO, Bryan Hanson as well as our CFO, Dan Florin. Before we get started, I would like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties. Also, the discussions during this call will include certain non-GAAP financial measures. Reconciliation to these measures to the most directly comparable GAAP financial measures, are included within the earnings release found on our website. In addition to the earnings release issued this morning, we have posted a quarterly presentation on our website at investor.zimmerbiomet.com, to supplement the content we will be covering this morning. With that, I’ll now turn the call over Bryan.
Bryan Hanson:
Thanks, Derek. Good morning and thank you for joining us today on my first earnings call as President and CEO of Zimmer Biomet. Since joining the company six weeks ago, I’ve had the pleasure of beginning a dialog with our key stakeholders, including many of our customers and distributors, senior Zimmer Biomet leadership and team members from around the globe. I’ve also connected with a number of our investors in addition to analysts who follow our stock. Candor and transparency have been important parts of this process and having an active and continuous dialog allows me to integrate a broad range of perspectives in developing our plans to lead Zimmer Biomet to higher levels of innovation, commercial success and profitability. Through these meetings, I’ve been gaining deeper insight into Zimmer Biomet’s operations and opportunities, both what we’re doing well today and importantly where we need improvement. Overall, my initial impressions have reaffirmed our rationale for taking the job as well as my confidence that my background aligns well with the work that the Zimmer Biomet team does and what needs to be done to position the company for improved performance. In speaking with our stakeholders, it’s clear that Zimmer Biomet is working from a strong foundation that includes the industry's broadest portfolio, a robust commercial pipeline, meaningful market share in key end markets and world class sales teams. By virtue of those strengths, we also have the potential to go beyond our share of leadership and large joints to drive diversified growth in a number of attractive markets, such as sports medicine, extremities and trauma. Our global scale and depth of portfolio also position us to continue expanding access to our solutions in under penetrated patient subset in global markets. In terms of our innovation capabilities, Zimmer Biomet is uniquely positioned to leverage platform technologies across our entire portfolio, including advanced proprietary materials and surgical robotics applications. As a company, we plan to build on this foundation. We will have an unwavering emphasis on patient safety and quality excellence, creating an engaged and innovative workplace and working to position the company to deliver top quartile total shareholder returns. And on a personal level, I've been inspired by the way surgeons have expressed their confidence in our portfolio and in our people. Zimmer Biomet’s 90-year reputation has been built on serving the needs of patients and surgeons and that resonates with my own values. All of that said, I'm not naive about the company's current challenges. I'm committed to turning Zimmer Biomet’s performance around with a deliberate emphasis on rebuilding revenue momentum in the near term as well as execution that leads to value creation. To get us there, I plan to draw on what I've learned from leading and building large global medical technology businesses. Working closely with the management team at Zimmer Biomet, we have been reviewing the 2018 operating plan to clearly define our go-forward strategies in a number of key areas. Although our review of the operating plan is ongoing, we have identified several immediate opportunities to improve Zimmer Biomet’s operational execution and address certain near term challenges. First, we will continue completing our quality remediation efforts at the Warsaw North Campus. Our teams have been undertaking this focused work over the past 13 months for the benefit of input from expert consultants. To support the success and quality compliance of our manufacturing network, we will also continue investing in the development of a best-in-class quality management system. Second, in order to return to offense and accelerate sales recapture, we will remain focused on fully restoring the supply of certain key brands within our knee, hip and SET categories. To that end, our teams continue to make progress on increasing the production levels of these products, which have been supply constraint due to quality remediation requirements and the non-automation of the North Campus. I reviewed the team's detailed plans for revenue acceleration through supply recovery and I'm confident as I said before that we have the right overall strategy in place. As I've dug into the details with the team, I see both opportunities and risks associated with the milestones within our schedule. My sense at this time is that these milestones represent more risk than opportunity. We will provide more details on our progress in this area when we provide full year guidance on our Q1 earnings call. Turning to our commercial strategy, our immediate priorities are to restore supply, engage with the sales channel and return to offense. I carried a sales bag when I started my career, which means I absolutely understand the vital role of the commercial team. Zimmer Biomet’s leadership is fully committed to reconnecting and rebuilding trust with our sales forces as they engage with our customers. In addition to sales recapture, we will also be focused on the significant number of commercial releases we have scheduled in 2018, including the critical additions of cementless and revision systems for our Persona knee family as well as the limited launch of the robotic application for knees. We have stressed to our commercial leaders that these new product introductions must be launched with excellence to ensure that they are catalysts for growth and share recapture. Last but not least, we are currently focused on gaining a deeper understanding of Zimmer Biomet’s culture. Together, we will build a cohesive company where our team members are engaged and valued, feel accountable for delivering on our commitments and act with a sense of urgency. Looking to 2018 and beyond, we will be focused on improving the predictability and consistency of our top line growth, which is a commitment to shareholders that I take very seriously. While I recognize that there is a lot of hard work in front of us, I’m confident that with the focused execution of our immediate goals, target investments in this business and a strong culture, we will raise our performance to a higher level and drive sustained shareholder value. With that, I want to turn now to the fourth quarter results. On a consolidated basis, we delivered improved top line growth in the fourth quarter. Our results benefited from several tailwind events in the quarter, including stronger than expected underlying US market growth, which likely reflected a step up in procedures due to insurance dynamics and a recovery from the Q3 hurricane impact. In addition, we experienced an acceleration in growth of our already solid performing Asia Pacific business, which benefited in the quarter from strong distributor orders. Consolidated fourth quarter net sales were $2.074 billion, an increase of 3% over the prior year period and 1.5% on a constant currency basis. Billing day differences provided a slight tailwind to the year-over-year growth. In the Asia Pacific region, we delivered a strong 7.2% quarterly sales growth and our Americas region grew 0.8% in the quarter. In Europe, Middle East and Africa, our revenues were relatively flat at a minus 0.3%. Full year net sales for 2017 were 7.824 billion, an increase of 1.8% over 2016 results on a constant currency basis, which included approximately 130 basis points of contribution from the LDR acquisition. From a market perspective, fourth quarter US knee and hip procedural volumes were quite strong. We estimate that US knee and hip increased around 2.5% during Q4 compared to flattish in Q3. With regard to pricing, we experienced negative pressure of 2.9% during the fourth quarter and negative 2.5% for the full year. Knee sales were flat compared to the prior year and were slightly better than our Q3 growth rate, due primarily to the stronger US market and increased demand for our Persona Partial knee system, which has continued to garner positive feedback. Despite the improved growth rate in Q4, we believe that the gap between our Americas knee growth and the overall market continued to widen in the fourth quarter. Looking forward, we will remain focused on restoring full supply of our knee product line as well as launching a number of important new products to drive future growth and narrowing our gap to market. Hip sales increased 1.6% during the fourth quarter and were driven by our strong performance in the Asia Pacific region where we had double digit sales growth. Although we improved quarterly sales of our Taperloc G7 and Arcos systems, supply constraints continued to limit our ability to meet the demand of these high growth brands. SET sales grew 4.6% over the fourth quarter of last year with numerous products across this category contributing to growth. We drove solid quarterly sales of our surgical portfolio and within upper extremities, we saw strong demand for the comprehensive shoulder during the quarter. Since November, we have received several FDA clearances in this subcategory and we are particularly excited about the US clearance of our Sidus shoulder. However, while we are encouraged that demand for these key brands remains high, we must restore supply before we can fully capitalize on these opportunities. As we work to resolving supply constraints that are a headwind on our SET performance, we will continue to invest in the success of these higher growth businesses. Turning to our dental business, sales were relatively flat during the fourth quarter. While dental sales in both the Americas and Asia Pacific region grew challenges from the restructuring of our dental sales organization in certain key Western European markets continued to impact our performance. We remain focused on our commercial and product initiatives to position this business for a sustainable growth. During the fourth quarter, sales of our spine, Craniomaxillofacial and thoracic businesses increased by 0.5%. While we benefited from strong demand of our Mobi-C Cervical Disc, our spine business continued to underperform due to revenue dissynergies related to our US spine sales force integration. We continue to work to resolve the impact of these dissynergies, including recent senior leadership changes and we expect to realize the benefit of cross-selling opportunities in the future. Our CMF and thoracic business contributed sales growth during the fourth quarter, with continued strong demand for thoracic products, driven by our SternaLock and RibFix Blu brands. With that, I'll turn the call over to Dan who will review our fourth quarter results in greater detail as well as our first quarter 2018 sales and earnings guidance. Dan?
Dan Florin:
Thank you, Bryan. I'll provide details on our fourth quarter financial performance and then cover sales and earnings guidance for Q1, 2018. As Bryan covered, our net sales in the quarter increased by 3.0% over the prior year period with an increase of 1.5% on a constant currency basis. Our adjusted gross profit margin was 72.7% for the quarter, in line with our expectations. This was 190 basis points lower than the prior year period due to continued incremental manufacturing and inventory costs, primarily at our Warsaw North Campus facility as well as the impact of price declines. Our operating expenses were higher than provided in our original Q4 guidance due to incremental spending on critical projects in our R&D portfolio as well as investments in our commercial channel. We also incurred additional expenses related to planning and implementing strategies related to US tax reform legislation. Our R&D expense was 4.6% of revenue at $95 million, essentially in line with the prior year. SG&A expenses were $771 million dollars in the fourth quarter or 37.1% of sales, which reflects lower non-sales force incentive based compensation expense compared to the prior year. In the quarter, we recorded pretax charges of $668 million in special items, 150 million of which were cash outflows for quality remediation, business integration and other items, the non-cash charges related to intangible amortization, certain legal matters and the goodwill impairment write off related to our spine business unit. Our diluted earnings per share for the quarter were $6.16, which includes a one-time tax benefit of approximately $6.40, resulting from the recently enacted US tax reform legislation. This adjustment is reflected in the income tax line and has been removed from our adjusted earnings. Adjusted fourth quarter 2017 figures in the earnings release also exclude the impact of the other special items that I mentioned. Adjusted operating profit in the quarter amounted to $644 million or 31% of sales, which was 130 basis points lower when compared to the prior year period, driven by the previously described decline in gross margin. Our adjusted effective tax rate for the quarter was in line with our expectations at 23.4%. Adjusted diluted earnings per share for the quarter were $2.10, a decrease of 1.9% from the prior year period on 204.1 million weighted average fully diluted shares outstanding. A reconciliation of reported net earnings to adjusted net earnings is included in this morning's press release. Operating cash flow for the quarter amounted to $403 million, inclusive of the $150 million of previously mentioned cash special items and our free cash flow was $275 million. During the fourth quarter, the company repaid $300 million of debt, bringing the total 2017 debt repayment to $1.25 billion. I'd like to now turn to Q1 2018 guidance. For the first quarter, we expect revenues to be in a range of $1.955 billion dollars to $1.995 billion, which includes approximately 300 basis points of favorable foreign exchange impact. On a constant currency basis, our revenue is expected to decline within a range of negative 4% to negative 2%. As a reminder, we have one less billing day in the quarter compared to the prior year quarter, which is negatively impacting these results. This headwind will reverse in quarters two through four, so that for the full year 2018, there is no net billing day impact. The step down from our Q4 revenue growth rate is due to a number of factors, including the impact of one less billing day, an assumption that the worldwide orthopedics market will soften somewhat from the Q4 growth rate, our expectation of a slower growth rate in our Asia-Pacific region in light of a very strong fourth quarter performance, which benefited from distributor orders as well as a temporary reduction in elective procedures in the UK. Regarding North Campus production, we expect our Q1 production output to be at least at the level we achieved in Q4. While we are not providing full year guidance today, I would like to share some details to help your models. We expect improvement from our Q1 sales growth rate as the year progresses, driven by the normalization of billing days, increasing supply levels as we progress through the year, enhanced commercial execution and to a lesser extent, the contribution from new product launches. Importantly, these new product launches should create momentum for our sales teams as we exit 2018 and enter 2019. Turning to EPS, for Q1 and the full year, our gross margin rate will be in a range between 72% and 73%, likely towards the lower end of that range in Q1 and improving slightly in subsequent quarters. Our gross margin rate will be a significant headwind for us in the first half of 2018 compared to the first half of 2017 and then should normalize in the second half of 2018, as we anniversary into the North Campus variances. We will continue to invest in critical areas on the commercial side of the business with a bias towards investments that drive near-term growth as supply recovers as well as core R&D initiatives, including the knee and robot projects previously mentioned. As we continue to assess our 2018 operating plan, there will likely be further changes to our investment profile. As a result, our first quarter projected diluted EPS is in the range of $0.73 to $0.88. After the elimination of amortization, inventory step up and special items, our adjusted diluted EPS is expected to be in the range of $1.84 to $1.91. This guidance assumes a first quarter effective tax rate in the range of 19% to 20%. In addition to my prior comments on gross margin, to help you with your P&L models, you should expect our full-year adjusted effective tax rate to be in the same range as Q1 between 19% and 20%. To be clear, we plan to reinvest the tax savings into the business to drive top line growth. Further, as we mentioned earlier this month at a conference, we have a year-over-year expense headwind on non-sales force performance based compensation programs. This headwind, which approximates $35 million is a result of not paying out full bonuses in 2017 due to shortfalls in operating performance. The majority of that expense is recorded in SG&A. We expect our Q1 2018 free cash flow to be in the range of $250 million to $300 million. As a reminder, our goal is to allocate substantially all of our free cash flow towards debt repayment. Finally, please note our guidance does not include any impact from other potential business development transactions or unforeseen events. With that, I’ll turn the call back over to Bryan. Bryan?
Bryan Hanson:
Thanks, Dan. Before we move to Q&A, I just want to take a minute and thank Dan. Over the last six months, he decided to not just have the hat of CFO, but also become CEO of the organization and I can tell you from talking to people, his leadership during that time really made people feel confident about the business. I just want to say thank you for the effort that you put in over the last six months and for the time that we've already spent together and I look forward to working with you. With that, I'll turn the call back to the moderator who will begin the Q&A portion of our call.
Operator:
[Operator Instructions] And our first question will come from Mike Weinstein of JPMorgan.
Mike Weinstein:
Bryan, as a starting point before we kind of get into the details of the business and some of the comments, [indiscernible] in the feedback that you've gotten from the commercial teams, from the distributors and reps, as you've had some early meetings with them, I know you've been traveling around a fair amount early on, kind of what you've heard on their view on the business, what the current state morale is and their relative enthusiasm for the changes that have already taken place and what's to come? Thanks.
Bryan Hanson:
So I've spent as much time as I possibly can with the commercial team so far, had an opportunity to spend a lot of one-on-one time with folks in the field. As I think you know, I've met with you before. And really, it's kind of a hand-in-hand, let's go visit the customer, let’s go to cases and let me live the life that you've got in that day that I’m there. And I got to tell you that, that combined with the recent kickoff meeting that we had for the Americas where there were a couple of thousand sales representatives there, I've had really good exposure early on to the organization. The first thing I would say is that we, no doubt in my mind, have the best sales organization in the industry. I feel very confident about that. This is a team that that is engaged with the surgeons, it’s extremely knowledgeable about the space, has energy around, what it is they think we can do. And so, so I'm very confident that we've got the right team. But what I see inside of it though and what I'm hearing from the organization is there has been, what I would define as a, maybe a lack of focus from senior leadership and engagement with the sales organization. They felt a little orphaned if you will and that’s going to change. It's changed already. I feel like just the time that I spent with them has been getting out pretty quickly, it’s spreading almost like a wildfire if you will the news of the time I’ve been in the field and I had an opportunity to spend about an hour, presenting to that broad team at the kickoff meeting and I can tell you that my enthusiasm on the stage was fueled by the enthusiasm that I felt from the audience and what they were hearing. And so I got to tell you that we're early on in this, but I believe we've already made as a senior management team, with the focus we've had with the commercial organization an impact. So to sum it up, I think we've got a great team. I think that we've got to work on the morale and the engagement and we've already begun that process, but I feel real confident about the team.
Dan Florin:
This is Dan. I'll just add to that briefly. Having been to a number of these sales meetings before, I can tell you the energy, enthusiasm and excitement of our sales team is off the charts compared to where it's been and the energy in the room was -- people were just using it with enthusiasm and Bryan did a terrific job and really connected with the sales team.
Mike Weinstein:
That's good to hear. Let me follow up on the supply side. Bryan, your comments, is that with -- I think you said the milestones represent more risk right now maybe than opportunity, could you just update us on where you are on supply coming out of the North campus and maybe set expectations for the year in terms of the cadence, so when you think you'll see products and when you'll be in a better position to go on the offensive?
Bryan Hanson:
So I'm going to give you kind of a comprehensive view of this thing because obviously I've been thinking a lot about it. So I apologize for probably a longer winded answer here. But I think, first of all, it's important recognize, I think Dan said it earlier that our performance out of that factory has stayed consistent with our expectations. So right now, we're consistent with what we've been saying. And I want to be real clear, the strategy that I see for the supply and recovery and really the comprehensive project plan that we see around this is sound. I have confidence in it. I do feel that the timeline we've communicated in the past, at the end of Q2, recovery is a possibility. So I just don't want to take that off the table. I do feel that's a possibility. That said, I do think there's more risk probably in a timeline than opportunity. And let me just give you an explanation for this and I kind of bifurcate my thinking on this in two different ways. The first piece that I think about is just the raw project plan, the risk of actually achieving a timeline of recovery, so that plan itself. And the second piece is what I define as kind of the delay that I think we're going to see in translating that recovery, that product recovery into accelerated revenue growth. Right? So those are kind of the pieces that I break this up and let me just first hit these, the supply piece. Again, I think that there are key milestones that we have in front of us that I think both have risk and opportunity in them, but the complexity of the project just tells me, just given my history with projects like this that most people believe inside of these timelines that things are going to go as planned and I put that in kind of air quotes. What I've learned over the years and I think most people have that run these complex projects is things never go as planned and unplanned events always occur. And as a results of just knowing that and kind of the spicy sense if you will and looking at it, I believe there's more risk than opportunity in the timeline that we see. So it just comes down to the complexity, history with projects like this, you usually see more slippage than you do see people pulling it in. That's the first piece. The second piece is really a thing that we probably most care about, which is how do we then take the supply recovery and turn that into or translate that into actual acceleration of revenue growth. And I think it's going to be more delayed than what maybe you're thinking and maybe even what I thought when I came in and a lot of this is as a result of the time I’ve been spending with the sales organization. And so here's my sense on this, this is kind of on two fronts. One, there's just a lack of trust right now from the sales organization for corporate. We have given them timelines that we have failed on and they've gone out through the information they have received from us, approach the customer only to have to pull back again. And so that lack of trust is going to create a situation where even when we have supply available, they're going to wait, they're going to wait. They've been defending their surgeons through logistics hoops they've been jumping through. They're going to wait with this new inventory, defend their surgeons without having to jump through those hoops and when they feel really confident that those surgeons are in place and intact, then they're going to go on the offensive. And when you think about this, and I’ve been in sales and I understand the process, it isn't a light switch that occurs. You've got to go out now and build the trust of folks because they haven’t been on the offensive, right, you've got to build the trust of other surgeons, you've got to build your offensive bullpen and then ultimately as a result of that bullpen, you start converting business. So there's a delayed impact of supply recovery as a result of that. So I just want to make sure that that's clear in the way that I'm thinking about it now and as I've gotten more educated on the topic and spent time with our reps. Again, I'm not going to give you specifics right now because that's going to come in our first quarter earnings call with guidance, but I will give you just kind of the way I'm thinking about it right now and you should be thinking about it the same way. I see this as a gradual revenue recovery into 2019. And if you're thinking about it in that way, I think it's the right way to put a lens on this and as we get smarter on the topic and burn down some of these risks through the milestones, we'll give you more insight, but that's where my thinking is right now.
Mike Weinstein:
And just before I let others jump in, I assume the FDA has not been in yet for re-inspection.
Bryan Hanson:
They have not and obviously that's a very material milestone that we're paying attention to.
Operator:
Our next question will come from Bob Hopkins of Bank of America.
Bob Hopkins:
My first question, I just wanted to follow up on some of the things that Mike was talking about as it relates to your comments about risk versus opportunity. And I just want to be very clear on your pipeline and whether or not to comment on risk versus opportunity, what that might imply for some of the things you guys have been talking about for a while now, specifically, could you comment on the timelines for cementless, for Persona revision, for the robotic platform, are those affected by the potential for more risk and opportunity as it relates to the North campus?
Bryan Hanson:
So I’ll give you just kind of my broad thinking on this, because obviously again this is a vector that I've been spending a lot of time on and I feel really good about the product pipeline that we've gotten. And as I said before, I've been out with stakeholders a lot and you can have the general managers and the marketing folks who rate people and give you a feel for whether or not we've got the right products in the pipeline. But what really sells it for me is when I go talk to surgeons who know about the pipeline and I talk to our sales reps who ultimately have to sell the pipeline and both those stakeholders are selling it, we've got the right pieces inside of the product portfolio and they're excited about getting those in the field as quickly as they can. I feel pretty confident about the timelines that we have. There's always in these things as you get closer to the end launch date, you get some slight slippage, but I don't see anything material there. The key to it though is this, right? When you look at just taking knee as an example, because it’s a big franchise for us, we've got the partial knee out now, using Persona technology which is getting great traction, it's a big first step in the right direction. We’ve got cementless coming up in the timelines we've communicated are ones that we still feel comfortable with. We’ve got revision and then robotics come in as well. That to me is a full portfolio that we need to truly get back on the offensive, all right, truly get back on the offensive. The key thing though is it's not the limited lines. That's where you're doing the learning. Really for me is when we get those out, get through the limited launch, get into full launch, that's when you've got full capacity with the bag and the way you should be thinking about that particularly with revision and robotics is the full launch will come anywhere from four to six months after a limited launch, which put us close to the middle of 2019. So if you're thinking about full capability, full bag in that very important segment for us in the knee, that comes around mid-2019. It doesn't mean we won’t get an opportunity to take advantage of the stuff that launches in between that, but the fully loaded for bear, attitude from the sales representatives will come in that mid-2019 timeframe.
Bob Hopkins:
And then just one other question I wanted to ask is a little bit more on -- centered on the fourth quarter and the comments on the first quarter and the guidance. Could you maybe help us sort of quantify some of the tailwinds that you benefited from in Q4 that you think will fall off in Q1? But I think you mentioned Asia, the hurricane, maybe the market softening a little bit, just I also assume there's probably a little bit of conservatism in those numbers as well. So maybe just talk -- help us quantify some of the things that helped you in Q4 that you don't think will be there in Q1.
Bryan Hanson:
So I'm going to pass it to Dan, but I just want to make a comment. I really do believe as we look at that Q4 to Q1 that this is a realistic number. I just want to make sure that that's clear. I see this as a realistic number with balance on both sides, but realistic in the view that we have on it. And Dan can speak to some of the specifics around it.
Dan Florin:
So Bob, in our prepared remarks, we talked about Q4 benefiting from a strong US market, which we had anticipated coming in for the quarter and then ended up being even slightly stronger than we initially guided to. So based on our models, we think knees are close to 3%, hips close to 2%, something in that range. So clearly a strong US market in hips and knees and shoulders and really procedurally across the board in the fourth quarter and difficult to precisely quantify how much of that’s the hurricane. We came into the quarter signaling that could be as much as 30 basis points. I'd probably stick with that type of an estimate. In terms of strength in the US market, we call that Asia-Pacific. Asia-Pac, really since the merger closed, continues to post above market growth on a consistent basis. The team is driving excellent execution in Japan, China, other countries as well. The stocking orders or the distributor orders in the fourth quarter also did benefit us. And then dental actually was stronger than we had expected on Q4. Now, as we approach Q1, we bring in a lot of factors. We do our best at looking at the past number of years in terms of seasonality from a stronger than expected Q4 and what that may look like in Q1. So as we said in the prepared remarks, where our assumption is that the worldwide orthopedic market does step down a little bit more than normal into Q1, as a result of the strength in Q4. So that's an element. We talked about the billing day differences, the Asia-Pac step down because of the absence of distributor orders in Q1 and the UK, the NHS announcing that they were going to push elective procedures out through February due to some capacity constraints that they have over there. And the last part would be, based on the strength of Q4, I think it's fair to assume that our field inventory levels on high running brands are really still depleted. And that will recover as the year progresses. So hopefully that gives you a sense of the tailwinds and the headwinds in to Q1.
Operator:
We will now move to David Lewis of Morgan Stanley.
David Lewis:
Just a quick clarification on Bob’s question, there is a lot of factors Bryan and Dan that vary from fourth quarter to first quarter. The one factor that does not appear to be a headwind, fourth to first is some change in the supply related dynamics. It sounds like fourth to first, supply is either at or better than it was in the fourth quarter. Is that a fair way of thinking about it?
Dan Florin:
Yes. That’s a good assumption. To me, it’s a non-variable when you look at the difference between Q4 and Q1.
David Lewis:
And then Bryan, kind of a strategic and financial question for you. I mean, if you got the guidance the first quarter and obviously it doesn't reflect necessarily all 2018, your gross margin is pretty close to what we thought. There does appear to be a little more incremental SG&A investments, some of that was compensation, which we knew about, but it does appear that you are going to reinvest in this business. Could you share with us a little bit about where you think that reinvestment needs to go? I think most investors are supportive of you doing it. Any thoughts you have on where you think it's needed I think could be helpful for people and then I had one quick follow up for Dan or you.
Bryan Hanson:
So I am 100% on the same page. We've got to have investment. We -- as an organization, we’ve been chasing the bottom line because we've had top line misses. And as a result of that, just obvious thing that we should have been doing to invest for growth is to have them happen in those moments, for all the right reasons, but the impact of that is negative now because we've got some catchup that we need to do. The things that we're going to be concentrating on is obviously investing for growth as a primary vehicle for growth. There is going to be two kind of pieces to this. We're going to have a biased near-term growth I think you guys would want that as well, but inside of it we’re still going to make sure that we earmarked money for research and development. We've got to spend more on research and development and bring on innovations that don't just help us in the near term, but also help us in the longer term. So, some of the money will go to R&D and unfortunately, there will be a longer tail to the impact of that from a revenue recognition standpoint. But that will be where some of the money goes. The rest of the money is going to focus on the commercial organization, which is really where we can invest, take advantage of the portfolio we already have and I see that in just broader investments in commercial structure to be able to have more feet on the street, some of those being specialized so that we can take advantage of the opportunity in SET, but a lot of it will be focused on just driving incremental feet on the street, focused on driving the portfolio we already have and taking advantage of the new products that we're going to be launching and very importantly, beginning to diversify our growth engines in to sports extremities and trauma.
David Lewis:
And then just last question for me is just, this quarter is sort of remarkable within hips and knees for a couple of reasons. One, it's the strongest hip and knee quarter you posted in a year, but it's also against the strongest pricing headwind I think you've seen in two years. I think you’ve talked about the factors of that hip and knee momentum that may not occur in the first quarter, but Dan or Bryan, what is that pricing number, 3.5% in hips and knees, was that sort of mix related in the fourth quarter and how do we think about that number heading into 2018?
Bryan Hanson:
Dave, we've seen fluctuations quarter-to-quarter on price declines. So at a company level, negative 2.9% in the fourth quarter, Q3 was negative 2.1%, so actually below the average. So second half was down 2.5%, first half was down 2.5%. So we're not concerned about that. We're still operating in that type of a range. Clearly when you get some distributor orders, you get some customer mix that comes into that map, but overall we still see price decline in the band that we've been experiencing recently.
Operator:
Our next question will be from Matt Taylor of Barclays.
Matt Taylor:
So I just wanted to follow up on that pricing question. I was curious because of the magnitude of this quarter. Do you think that your supply constraints are impacting your ability to get price or negatively impacting price at all or is this just within a regular band variance?
Bryan Hanson:
Yeah. We're definitely looking at it right now as a -- just a variation that occurs, probably more due to mix. If you think about APAC for instance with the strength that we saw in the quarter, for the same products in APAC, you typically get a little lower price and so that mix, I'm sure, has some play in to the quarter, but we're not looking at this as something that’s sustained or that we're worried about increasing over the next 12 months. And when I think about the supply constraints, I don't feel that the organization is putting price reductions in place to retain customers, which I think is what you're asking. So I don't feel that that's happening right now and we've got pretty good controls over pricing flexibility in the field and our confidence level that that's not occurring.
Matt Taylor:
And just to follow up on the supply discussion, we noticed that you had taken off extremities from the watch list in the presentation, you didn't mention that they were constrained. I guess my question is can you talk about some of the lines of product that have improved or not improved and just remind us sort of where you are constrained now.
Bryan Hanson:
Yeah. Just quickly that might have been just an oversight, the extremities as we've been talking about, continue to be constrained as a result of the North campus. So I'm not sure what we missed that, but that would be consistent with what we said before. It is still impacted and what I would say is that generally, the way I think about supply recovery is this and again this is coming from direct interaction with the field. Even though we're getting rolling recoveries, certain categories are getting more healthy than others. The sales organization is still waiting to get the full recovery. They still are concerned when we have other issues with other products that we're going to creep into the spaces that we've already recovered, because we've had lapses like that in the past. So it kind of goes back to that trust piece. Even though things are recovering, they’re waiting for full -- truly a full comprehensive product recovery before they go on the offensive. So, I think we're not seeing the translation yet even in those areas for recovery, because people are waiting to get it all there so they know they can go on the offensive. A perfect example of that, Dan maybe you can provide the Oxford in what you’ve heard on –
Dan Florin:
Sure. Yeah. I think Bryan’s point is an important one, which is that lack of trust in the field, the hesitancy to go on offense and the need to have the full bag in order to truly drive offense. So, there are brands out of the North campus that we've restored to full supply as we expected, but the translation to revenue acceleration and that timeline that Bryan is talking about is an important distinction. Part of that is trust, part of it is the duration of the supply situation, but still feel very optimistic that out over time, we're going to bring all of the supply and new products together to drive that acceleration into 2019.
Matt Taylor:
You want to give maybe the specific examples, because I think it really kind of remains true with even telling the sales organization, we're in full supply in Oxford and seeing a delay.
Bryan Hanson:
Sure. Yeah. With Oxford, we’re at full supply in Oxford, entering the fourth quarter. We're excited to have the Persona partial knee in there as well. So now you've got a full bag of mobile bearing and fixed bearing in the partial knee space. But still even with that full supply of Oxford, saw some delay in terms of the revenue uptake on Oxford. It's taking longer than we expected to see that accelerator. So that’s I think a proof point of what we're describing.
Operator:
We will now move to our next question and that will be from Kristen Stewart of Deutsche Bank.
Kristen Stewart:
Just kind of I guess big picture for you, I guess to what extent, I guess, are you still excited about costs taking kind of a life of its own, I kind of feel what extent do you still feel very optimistic about the future for Zimmer, because I feel like this -- you've kind of pointed out a lot more of the risk factors. So maybe if you could take a step back and talk about maybe some of the things that you've kind of come in and looked at Zimmer, the pluses and the minuses, since taking over the helm six weeks ago that you might be more excited about longer term as you look at the company more strategically over the next several years? Is it just kind of your view of looking at Zimmer from an orthopedic Company, can you maybe talk about how you may look at Zimmer from shaping the company more directionally? Is it diversification? Is it just getting the company back to -- are you satisfied with a low single digit growth rate? Can you just talk more directionally over kind of a longer term perspective?
Bryan Hanson:
Yeah. So Kristen, first, I'm going to correct you. This is Zimmer Biomet, not Zimmer and I think it's important because one of the key things that I'm going to be concentrating on is culture in this organization in some of the things that are in a way of that culture creation right now is we just haven't yet become a fully integrated new organization. There's still camps of Zimmer and Biomet and we need to create the Zimmer Biomet, forget the legacy companies. And sorry to do that, but I think I would be remiss in not doing that because I know that my own team is listening right now. So that was a focus from them. So just to give you a sense for, I kind of like to think about things that I experience over the last month that maybe I didn’t like as much as I would have expected and then things that I like more than what I expected. And then maybe I can kind of distill that to say, based on those things, how am I feeling about accepting the job and the future of the company. I’ll start with the negative and finish it with the positive. The things that I probably experienced in a more negative way than I expected is just the complexity and the challenges, the scope of the challenges associated with quality remediation and supply recovery. It's more complex than I think I assumed when I came in. So that would be on the negative side obviously. The culture gap, which was kind of what I was just referencing on the Zimmer Biomet discussion we just had is wider than I expected. And I got to tell you that this organization, because of what they've been through, throughout the organization, is fatigued. I can feel the fatigue in the organization and when the culture is not rock solid, that fatigue is exponential, right? And I think that's the issue that I'm seeing and that was -- it's probably not as good as I was even hoping. So those would be the things that on the negative side I’ve experienced over the last 30 days or so. On the positive side, we’ve got great employees and I’ve spent a lot of time in skip level meetings, one-on-ones, just walking around, popping in people's cubicles, spending time out in the sales organization, spending time in our factories. We have a solid team in the sales organization as I think I've said already is even better than I thought. We have a first class sales organization. I didn't. Like I said, that’s a surprise, but it's a relief, right. The portfolio is very attractive. I thought that coming in, but I'm hearing from our surgeons partners that we have the deepest, broadest portfolio in the industry that is the access to what obviously and they're very excited about the portfolio of products we're going to launch, so that my confidence level there is higher than it's ever been. This kind of surgeon loyalty and again I've spent time specifically with surgeons and the stickiness associated with that customer is better than I've ever seen in any business that I've been with. And so that’s a surprise on the positive side. Here's one of, maybe a little softer, but it is really important to me, the employees that I've met feel very open to me, most desire a different form of leadership, a more inspirational positive form of leadership and this is something that I love to bring. And so I'm not feeling any resistance at all to it. I'm feeling an acceptance of it and that obviously is one of the things that I was hoping for, but I'm realizing and it’s still kind of, it’s still these things. I feel and I think the takeaway has got to be this. The cadence of recovery may not be what you were hoping for, but my confidence level right now is better than ever that this business is going to get turned around, I’m 100% confident it's going to happen based on what I'm seeing. And to answer your question further, once we get to that stability place and we get our fair share of the market where I already play in, then I do want to take a step back and take a look to say, are we in the right markets to allow for a better weighted average market growth and ultimately through that weighted average market growth, allow us to grow in that mid-single digit growth rate at some point in the future, because that's the only way you're going to get to double digit EPS growth on a consistent basis. And so I don't want to go there yet. I'm not always patient, but right now I'm trying to be patient, put that on the back burner. Let's get to health first and then ultimately let’s take a look at the portfolio and make the right decisions. So hopefully that answers your question.
Kristen Stewart:
And then just one for Dan I guess and maybe you I guess in terms of just the guidance, what is the main sticking point or what's the main catalyst in terms of determining what the investment trigger is going to be? Is it mainly just what the right level of spend is for the remediation? Is that why they’re hesitant to push off into the first quarter to get 2018 guidance in terms of giving why not a wide range for 2018 and set a no range for 2018 since you’re giving SG&A and gross margin guidance?
Bryan Hanson:
I will just give you my viewpoint on it, Kristen and then Dan, he will provide any color. When I look at this as I’ve mentioned, there are a lot of moving pieces and parts right now, pretty material events that need to happen here over the relatively short term. And until we get through some of those and in either one burn down risk as a result of passing those milestones or experience risk, I think that we just want to be cautious in giving you guidance until we get a little smarter on those topics. And the only thing that's going to make us smarter beyond the assumptions that we made is actually pushing through the milestones and experiencing the good or the bad. And when we get to the earnings call after Q1, we're going to be a lot smarter on that topic. And so we're really just trying to enable guidance for you that is more realistic and more informed and that's the reason why we’re delaying. There isn't a specific thing. There are a number of things that are pushing us in that direction. And Dan, I don’t know if you have any other color around it?
Dan Florin:
Well, Kristen, I would just say that we've tried to give you some markers on certain elements of the P&L so that you can reflect those in your models. Look, I would expect that the consensus estimates for both revenue and EPS are probably going to come down after today in light of what we have shared, but that does not diminish at all the long term opportunity that Bryan has talked about.
Operator:
We will now take a question from Joanne Wuensch from BMO Capital Markets.
Joanne Wuensch:
Can we also take a look at what the milestones are or the steps are in our near term that will increase our confidence in giving the guidance or just over the next 12 months. I feel like we have some sweeping verbiage on execution in North Campus facility and supply, but is there a way to get just a little bit more granular on what really needs to be checked off?
Bryan Hanson:
Yeah. Probably, one of the and I'm not going to get into too much detail, but I think just probably when we think about supply recovery, which I think all of us would agree is one of the most important components of that revenue acceleration we've been talking about, the first and foremost, you've got to again kind of bifurcate the activities that we've got in place, one of these is taking those processes that are most important to us with high volume products that are non-automated in the North campus and moving them to contract manufacturing that ultimately have a more automated process, proven track record of supplying products like these for others in the industry and transitioning that volume to them. Just inside that one piece, that has to go right, this is not just one or two codes, these are families of codes. There's a lot of the SKUs that have to go through this process. There is a verification, and validation process that ensues. And there's nothing you can really do to speed this up. It's time sequence because a lot of it would be like fatigue testing for instance for an implant, but you can get through a million different iterations or movements with this product to check speed testing, find out that it fails, because you got to get 5 million. Then you got to find out why it failed and restart the whole process. So verification and validation is something that sounds very easy and ultimately we will absolutely get through it, but things always go wrong inside of that and you got to restart the clock as a result. So one of the biggest things that I'm focused on is what is our target dates associated with families that we have that we're moving out on that verification and validation timeframe, when do we think that should close, right? And so when we hit those and we passed them and that will be, we should hit all of those before the quarter earnings call. And so we'll get a lot smarter on whether or not we had major issues or not. That's just one example of things that need to go right to be able to get that supply recovery because the only pathway to full capacity is through that contract manufacturing. On the other side of the coin, when you look at our factory in the North Campus and one of the big things that Mike mentioned is, the FDA still has to come in and sanction what it is we're doing with suppliers -- and with the quality remediation. We have a great team working on this. We've been working on it for a month. We're spending a lot of money in this area and a lot of effort of senior management and we have consultants that I think are some of the top notch folks in the industry following us on this and giving us their unbiased view of whether or not we're achieving what we said. But at the end of the day, the FDA has got to come in and look at what we're doing and agree with us. If they for whatever reason come in and disagree and there are further things we have to take action on with remediation, that could impact our ability to supply product out of that North Campus. These are just two examples of pretty significant things that we just got to have time to tell us whether we're on the right track. There are many others. I want to oversimplify, but those are pretty big milestones.
Joanne Wuensch:
And then a little bit more of a specific question. Can you pull apart a little bit what's going on in your spine and CMF franchise, as it relates to LDR and then the broader market?
Bryan Hanson:
So if I kind of break those businesses up, within spine and CMF, obviously two different businesses, but CMF is actually doing pretty well. That's a solid team that we have, good strategy that continues to deliver results and really help that overall franchise out. So, I’d just say, kudos, let’s keep doing what we’re doing over there and get more of it. On the spine side, I think we've got all kinds of opportunity in spine. This is an amalgamation of different acquisitions over time, LDR being the most recent and where we're falling down right now is, the channel integration is not going as planned and we're experiencing, as we said in the comments, dissynergies associated with that channel integration. And just to be honest, we had to make some changes at the senior leadership team for that organization. We think we've got the right team in place right now. Now, got to get focused on reversing some of these dissynergies and getting a better channel strategy in place. I do believe that can happen. It’s going to take time because just looking at it, it's not anywhere where we needed to be and that we've got to unwind some of the things that have occurred there. But at the end of the day, when that gets past us, we have a very full portfolio that's exciting for our customers and exciting for our sales reps. We just don’t have the channel strategy to implement it right now.
Operator:
And that question will come from Richard Newitter of Leerink Partners.
Richard Newitter:
I was hoping to just on the outlook that you plan to provide next quarter and I appreciate you don't want to go too far in advance of yourself, but maybe just the question is a little bit more on the process. Coming off of a period here, where we haven't been able to fully bank on kind of the given timelines or thresholds that you provided, what's going to change in the way that you approach kind of the under promises over deliver and within the context of you seem a lot of things that are out of your control, how should we be thinking about when you do provide that outlook? What kind of bottoms up processes you need to change at the organization so that you feel confident that whatever you do provide, we can kind of take at face value?
Bryan Hanson:
So some of the things that I've learned over the years and I've been blessed by working with two very good companies, Covidien with a lot of time there and Medtronic more recently. And on the Covidien side, there is a level of discipline and rigor that I received from my old boss and mentor [indiscernible] and that rigor and discipline will be something that we put in place here and I'm not saying it doesn't exist, but the level of focus that I will have with this team in putting a process together that allows us to feel more confident in the guidance that we give will be something that we do. And not new to me and there is a process that I'm used to following and we're going to make sure that we bring that here. And we've got good people to be able to do it. It's just a -- it's a level of discipline and rigor that I've seen that I want to make sure that we have here as well. So that's one piece and I think it would be helpful, we’re obviously not ready to give 2018 guidance, certainly not anything beyond that, but I do want, again with this idea of full transparency, I want to give everyone a view of kind of what I'm thinking about this right now and I kind of again think about it in three major components that we've got to get in front of us here. The first one as I've already talked about is supply recovery and I don't want to forget that supply recovery is the first step. The second step is translating that supply recovery into actual revenue acceleration, right? And I’ve talked a little bit about why I think some delays could occur there, but that's got to happen. It's got to be supply recovery acceleration as a result. Second piece is, we’re going to launch these products, excellent product pipeline that I’ve talked about and we got to get to full launch as quickly as we can. I'm seeing that as being somewhere in the mid-2019 timeframe but that has to happen and we've got to do it effectively, right? And then the second -- the third piece to me is really around this idea of culture shift. I know that people consider it soft. It is a very important thing to me and right now, we have gaps in the culture and we've got to enhance the culture. So those three things need to happen. I just think logically about those from supply recovery and resulting acceleration, that's going to happen later in the year guys. It's later than what you've been thinking, because translating that into revenue growth is going to take longer than maybe what you're assuming. I already said the pipeline is really full swing in mid-2019 and anyone who's done any kind of a culture change knows that it takes time. We're having immediate impact in this area. We're going to get quick results out of the gate, but to make it sustainable, it's just going to take time. It's a continuous improvement game. So when I just kind of put all those things together, I think realistically the way we should be thinking about this is a gradual recovery towards market growth if you will through 2019. So think about it in that way. That's where I am. I'm going to get smarter on this topic. I'm going to learn more as we go and the very things that we just said as we burn down risk areas, but this is the way I'm thinking about it today. Some of you may have a hope for a faster recovery than that and I get it and potentially maybe it can be, which is based on everything that I'm seeing right now, I'm setting the expectation that I think is realistic that that's probably not probable. Okay. It is likely going to be what I just said. It would be a gradual recovery through 2019. So hopefully that helps provide color, at least in the way we're thinking about the business right now.
Bryan Hanson:
Okay. I think that’s the last question. I like to -- we just threw a pot at you in a very short period of time. Some of it probably stuff you didn't want to hear, didn’t expect to hear. At the end of the day, the whole idea behind this from my perspective and Dan’s is, we want to be as transparent with us as we possibly can and that was the intent of the conversation today. Let you know what we know, up to a reasonable point obviously. We didn’t get to this place overnight and you shouldn't expect us to be able to recover from it any time soon. It's going to take some time to get there. That said, based on everything I've learned, I am more confident than ever that this business is going to turn around. Although the pacing may not be what you expected or hoped for, I'm 100% confident that the end game is going to be something you're going to be very happy about. So thanks so much. I appreciate you joining the call today. I'm looking forward to connecting with you between now and earnings call, I’m sure, through various events, but really looking forward to connecting on the first quarter earnings call as we give guidance for 2018. Thanks so much.
Operator:
And thank you again for participating in today’s conference call. You may now disconnect.
Operator:
Good morning. I would like to turn the call over to Matt Abernethy, Vice President, Investor Relations and Treasurer. As a reminder, today’s call is being recorded. Mr. Abernethy, you may begin you call.
Matt Abernethy:
Thank you. Good morning and welcome to Zimmer Biomet’s Third Quarter 2017 Earnings Conference Call. I am here with our Interim CEO and our CFO, Dan Florin. Before we start, I would like to remind you that our discussions during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties. Also, the discussions during this call will include certain non-GAAP financial measures. Reconciliation to these measures to the most directly comparable GAAP financial measures, are included within the earnings release found on our website. In addition to the earnings release issued this morning, we have also posted a quarterly presentation on our website at investor.zimmerbiomet.com, to supplement the content we will be covering this morning. With that, I’ll now turn the call over Dan.
Dan Florin:
Thank you, Matt. Our third quarter results fell short of our expectations, driven by external and internal factors. These factors included softened domestic market conditions, the impact of the hurricanes and the Indian knee price reduction, as well as the pace of our supply recovery and the related delay in sales recapture within our U.S. business. We know that Zimmer Biomet can and must perform at a higher level and significant work continues to ensure that we deliver on our commitments to our customers and our stockholders. During today’s call we will provide our insight into what drove the sales and production shortfalls within our U.S. business. In addition to our detailed plans to get our performance back on track, we will also provide an update on our production and sales recapturing initiatives to improve our near and long term results with respect to our U.S. business. Finally, we will discuss U.S. market conditions and our global performance by product category. First, I want to take a moment to acknowledge the communities affected by the devastation of hurricane Harvey, Irma and Maria. We are thankful to report that all of our team members in the affected regions are safe. During the third quarter our revenue was impacted by these storms, resulting in approximately $5 million of headwind. Regarding our production at our Puerto Rico facilities, where we primarily manufactured some hip and trauma products, like many, we have encountered problems of mainly consistent power causing a more gradual return to full production than originally anticipated. Given the continued instability of infrastructure in Puerto Rico and current safety stock levels, we now expect some minor sales disruption in the fourth quarter and into 2018. Additionally, the government of India initiated a significant knee price adjustment during the quarter. This action has caused much disruption in the India market, resulting in a headwind of $5 million for the third quarter. Turning to our results, we achieved net sales of $1.818 billion excluding approximately 30 basis points of contribution from the LDR Holding Corporation acquisition. Third quarter 2017 revenues decreased by 1.1% from the third quarter of 2016, representing a decrease of 1.5% on a constant currency basis. Our results were negatively impacted by approximately 130 basis points due to having one less billing day through the quarter. On a constant currency basis, our Asia Pacific sales increased by 5.2%, while sales in the Europe, Middle East and African region decreased by 0.4% and sales in the Americas decreased by 3% compared to the prior year quarter. Let me now take you through our plans in greater detail. During the third quarter we made good progress in the execution of our quality remediation plan at the Warsaw North Campus and we remain on track to achieve the key milestones laid out in our Form 483 responses provided to the FDA in December 2016. These efforts will continue through 2018 as we have previously highlighted and will remain a key focus of our entire company. On the production front at our Warsaw North Campus, we achieved lower than anticipated production output of several key brands due to inconsistent yields from certain more complex manufacturing prophecies, as well as increased attrition beginning in August among our temporary direct labor workforce in Warsaw. This resulted in third quarter output being below our targeted level. . Reaching targeted and consistent output for certain manufacturing prophecies has proven difficult due to the added quality compliance measures, including in-process monitoring implemented as part of our remediation plans. Given these challenges we have accelerated our planned dual sourcing strategy for the previously mentioned manufacturing processes, which we expect will provide additional capacity starting in the second quarter of 2018. Within the current manufacturing environment we continue to make ongoing engineering process improvements, including targeted investments into equipment and key technical expertise to improve process constancy and output. As it relates to staffing, we have implemented new strategies to provide resource stability for the Warsaw North plan, including temp to direct hiring, to ensure we attract and retain the required skilled labor in Warsaw. We remain intently focused on resolving these challenges. For brands not impacted by the previously described process complexity, we expect to clear back orders and replenish safety stock consist with prior expectations, resulting in full supply by the end of the fourth quarter. For those brands attached to the more complex processes, we expect both backorders and safety stock levels to improve over the coming quarters, achieving full supply on all products during the second quarter of 2018. I would now like to turn to our sales recapture program in the United States. The production shortfall is directly impacting our ability to fully meet case demand and go on offence. During the third quarter we continued to experience low inventory levels across key brands within our knee, hip and S.E.T categories. Supply is the foundation to enable our sales recapture program and as supply improves, we expect the logistical burden on our sales forces to decrease, allowing us to better serve all of our customers and go back on offence. During the interim, our sales forces has focused on products that have not been impacted by temporary supply challenges, such as our market leading Persona Knee System, which recorded strong growth during the quarter. We also launched our Persona Partial Knee System, which is realizing positive momentum due to encouraging market acceptance. In addition, we have enhanced our customer engagement and responsiveness with chartered internal teams to ensure customers are bring appropriately communicated with as we work through production and supply initiatives. We also continue to make investments into our specialized sales forces and sales rep incentive programs to accelerate growth. Our global commercial organization and team members worldwide have shown tremendous resiliency and I am proud on their hard work and dedication. We know what we need to do and our team is working diligently to achieve our objectives. While the pace of our production and sales recovery has not met our expectations, I am encouraged by my interactions with many of our surgeon customers who continue to place their confidence in our portfolio, our pipeline and our people. As I alluded to earlier, a number of factors in the Musculoskeletal Market have impacted our results, including the previously mentioned effect from the hurricane and the knee price action by India. Further, we saw moderate step-down in knee and hip procedural volumes in the United States. Based upon those who have already reported, we estimate that third quarter U.S. Knee and hip market to be flat to positive 1% on a day adjusted basis, which was lower than our expectations. These quarter-to-quarter market fluctuations appear to have driven by U.S. insurance dynamics causing more variability in the timing of procedural volume and contributing to our lower than anticipated third quarter sales. We view these market fluctuations as temporary and believe underlying market demographics point to a sustainable global knee and hip market growth rate up between 2% and 3%. With regard to pricing, we experience negative pressure of 2.1% during the third quarter. Turning now to performance by product category, as a reminder the growth rates I quote are on a constant currency basis and have not been adjusted for the 130 basis point impact from one less billing date during the quarter. Our third quarter knee sales decreased 1.7% from the prior year quarter, reflecting positive volume and mix of 0.8% and negative price of 2.5%. We continue to drive strong knee growth in the Asia Pacific region, where we generated approximately 4% constant currency sales growth, inclusive of the effects of the price action in India. We were also pleased with our sales results in the Europe, Middle East and Africa region. In the Americus our knee franchise was impacted by a softened U.S. market, as well as the headwinds I mentioned earlier related to supply shortfalls, which limited our ability to accelerate revenues. As we continue to work aggressively on resolving these near term challenges, we remain focused on a number of important development products to drive future growth. As I mentioned earlier, in September we announced the launch of the Persona Partial Knee system, which provides us with the ability to participate in the important fixed bearing segment of the partial knee market and complements our clinically trusted Mobile Bearing Oxford Partial Knee. The Persona Partial Knee also represents our first significant jointly developed new products since the Zimmer Biomet combination. We also continue to make steady progress towards the planned launch of our Persona TM Tibia Cementless Knee and the clinical evaluation of our Persona Revision system in the second half of 2018, as well as the clinical evaluation of our ROSA robotics platform for knee replacement application. In addition to these development projects, after reaching the milestone of over 500,000 Persona Knee procedures, our knee teams showcased the clinical success and versatility of our Persona Knee system to hundreds of surgeons at a global webcast surgical education event. The webcast was very well received and provided continued optimism for the future success of our Persona platform. Third quarter hip sales decreased 1.7%, reflecting positive volume and mix of 0.8%, a negative price of 2.5%. While we continue to achieve solid sales of our G7 Acetabular System, our Taperloc Complete Hip Stem and Arcos Modular Femoral Revision System; our hip performance remained challenged by supply constrains. As we focus on fully restoring production levels and closely engaging with accounts impacts by the temporary supply disruption, we will continue to pursue improved growth across our comprehensive hip portfolio, along with several important development projects. Now turning to our S.E.T product category; revenue increased by 1.1% over the prior year quarter. Our specialized sales forces delivered solid sales of our Gel-One and Subchondroplasty treatments, as well as our Quattro Link Knotless Anchors, the A.L.P.S. Total Foot System and our IntelliCart System for fluid waste management. Our surgical team had another quarter of strong execution and sales growth as a result of their dedicated sales channel and broad product offering. However, our overall S.E.T sales growth was challenged due to supply constraint that limited our ability to drive offense within our Sports Medicine, Extremities and Trauma portfolios. We remain focused on restoring supply levels across the entire range of our S.E.T offerings. In addition, we plan to introduce several new products in 2018, including our comprehensive Shoulder Augmented Baseplate, as well as a Stemless Shoulder offering, which we expect to be important growth catalyst. Our third quarter dental sales decreased by 4.4%. We continue to restructure our dental sales organization, specifically in some key Western European markets, which we expect to positively impact sales performance in 2018. Our dental business remains focused on executing both commercial and portfolio initiatives to shape the business for sustainable long term growth. Revenue from our Spine, Craniomaxillofacial and Thoracic category increased by 0.3% over the prior year quarter. We continue to belief from sales of our market leading Mobi-C cervical disc, however our spine performance came in below our internal exceptions due to near term revenue dis-synergies related to the commercial integration of our U.S. spine sales force. We are working diligently to mitigate these disruptions and to enable optimal cross selling through increased training and investment into working capital. Among our Craniomaxillofacial and Thoracic offerings we achieved another solid quarter of growth, supported by sales of our Trauma One Plating System and SternaLock Blu and SternaLock 360 primary closure systems, as well as our RibFix Blu Thoracic Fixation System. I will now turn to our third quarter financial details before providing additional information related to our fourth quarter sales and earnings guidance. Our adjusted gross profit margin was 73% for the quarter and was 210 basis points lower than the prior year period, due primarily to lower gains from our cash flow hedging program, additional manufacturing costs at our Warsaw North Campus manufacturing facility and the impact of price declines. Gross margin was lower than anticipated, due primary to regional and product mix of our third quarter revenues. Our R&D expense was 5% of revenue at $91 million, a slight decrease from the same period in the prior year. We continue to prioritize R&D spending on what we believe are the most impactful programs, including our important knee programs, our robotic applications novel case fulfillment approaches and Zimmer Biomet Signature Solutions among others. SG&A expense was $695 million in the third quarter or 38.2% of sales, 150 basis points lower than the comparable period in the prior year and consistent with 2017 trends. In the quarter we recorded pretax charges of $328 million in special items, which include $188 million of non-cash amortization, inventory step-up and a good will write-off related to one of our small non-core businesses. Special items also included $50 million of quality remediation expense and $90 million of integration expense and other items. Our diluted earnings per share for the quarter were $0.48 versus $0.78 in the prior year period. Adjusted third quarter 2017 figures in the earnings release exclude the impact of the special items that I just mentioned. Adjusted operating profit in the quarter amounted to $542 million or 29.8% of sales, which was 40 basis points lower when compared to the prior year period, driven by the previously described gross margin decline, partially offset by SG&A improvements. Our adjusted effective tax rate for the quarter was in line with our expectations at 23.2%, an increase of 210 basis points from the third quarter of 2016. Adjusted diluted earnings per share for the quarter decreased 3.9% from the prior year period or negative 0.6% excluding the impact of foreign exchange to $1.72 on 204 million weighted average fully diluted shares outstanding. A reconciliation of reported net earnings to adjusted net earnings is included in this morning’s press release. Operating cash flow for the quarter amounted to $463 million, which reflects $111 million of cash expenditures, primarily for quality remediation initiatives and integration activities. Free cash flow in the third quarter was $344 million, $142 million higher than the third quarter of 2016. During the third quarter the company paid down $490 million from our term loan and increased our borrowings by approximately 21.3 billion yen for our Japanese loan vehicle. Therefore when combined with our activities for the first half of 2017, gross debt reduction during 2017 has been $950 million. I’d like to turn now to our updated guidance. As a result of the previously described pace of supplier recovery of certain key brands manufactured at our Warsaw North Campus facility and the related impact on sales recapture, primarily in the U.S., we are adjusting our fourth quarter and full year revenue and earnings outlook. For the fourth quarter we expect revenues to be in the range of $2.10 billion to $2.50 billion, which includes approximately 175 basis points of favorable foreign exchange impact. On a constant currency basis, our growth rate is expected to be in a range of negative 1.8% to positive 0.2%, inclusive of a 20 basis point contribution from selling day impact compared to the prior year period. Therefore, our billing day adjusted constant currency growth rate is now expected to be in the range of negative 2.0% to 0%. For the full year 2017 our estimated revenue growth is now expected to be in a range of 1% to 1.5% over the prior year. Foreign exchange is now expected to increase revenues by 0.1%. Taken together, constant currency revenue growth over 2016 is expected to be in the range of 0.9% to 1.4%, inclusive of 120 basis points of acquired revenue from the LDR acquisition. In dollar terms, our full year 2017 revenues are expected to be in a range of $7.760 billion to $7.800 billion. Our expected dollar range is down from our previous guidance range of $7.800 billion to $7.870 billion, with favorable foreign exchange partially offsetting the reduction in our constant currency growth rate. Turning to EPS, the earnings flow-through from our lower sales expectation will again have a disproportionately negative impact on our fourth quarter profitability due to the regional and product sales mix, which is only partially offset by favorable currency adjustments versus our previous outlook. Additionally, we continue to invest in critical areas such as specialized sales forces, sales incentive programs, core R&D initiatives, including the knee and robot projects previously mentioned and sales support cost to maximize customer engagement. We will also continue to incur incremental manufacturing and distribution costs, primarily in the Warsaw North Campus facility. These increased manufacturing costs are expected to continue to have a negative impact on gross margin throughout 2018, until we implement our dual sourcing strategy and more efficient and automated manufacturing and quality control processes. Our fourth quarter projected EPS is in the range of $0.94 to $1.08. After the elimination of amortization, inventory step up in special items, our adjusted EPS is expected to be in the range of $2.08 to $2.14. This guidance assumes the fourth quarter effective tax rate of approximately 23.5%. As a result, full year earnings are now estimated to be within a range of $3.80 to $3.93. Special items for 2017 are estimated at approximately $1.260 billion. This is an increase of $25 million from our previous guidance, which is driven by the previously mentioned goodwill write-off, partially offset by lower integration costs. We expect investments in our quality remediation program for 2017 to be consistent with previously stated amounts. We expect our full year adjusted effective tax rate to be approximately 22% as we continue to execute important initiatives that will benefit our future effective tax rate. Excluding the impact of amortization, inventory step up and special items, we are reducing our full year 2017 adjusted earnings per share guidance to a range of $8.01 to $8.07. This EPS range represents approximately 0.5% to 1.5% growth over the prior year or 4% to 5% growth when excluding the impact of foreign exchange. We expect free cash flow to be in the range of $1.125 billion and $1.225 billion. We expect to continue prioritizing our free cash flow in the fourth quarter towards debt repayment, continuing our path towards reduced leverage. Finally, please note our guidance does not include any impact from other potential business development transactions or unforeseen events. Before we move on to our Q&A, I want to provide an update on our board search to select our next CEO. The process is ongoing and our board continues to make good progress, as it is committed to a thorough and timely search process. In closing I’d like to reiterate that we are not satisfied with our current results. Looking forward, we are focused on addressing our production challenges, to allow for greater sales recapture and to enable our sales teams to go back on offence. We will also continue to leverage Zimmer Biomet’s diversified portfolio and a strong pipeline. The new products scheduled for release over the coming 18 months provides further optimism for getting our performance back on track and improving our growth profile. With that, I’ll open it up to questions.
Operator:
Thank you, sir. [Operator Instructions] Our first question comes from Bob Hopkins with Bank of America.
Bob Hopkins:
Thanks and good morning. So it seems to me looking at this release these are our two big changes. One is the remediation supply issues taking longer and the second one is just that the U.S. market is weaker. Before I get to those two, which will be my two questions, I just wanted to clarify, in the third quarter what was your organic growth, organic revenue growth adjusting for selling days, LDR and weather. I just want to make sure I have that number, because it’s not 100% clear from the release.
Dan Florin:
Sure Bob. So on a constant currency day adjusted basis backing out the LDR contribution its negative 0.2% and we described in the release or in my prepared remarks rather, that the impact of the India knee price cut and the hurricane impact is about, call it 50 basis points. So adjusting for that, call it a 0.3% Q3 performance.
Bob Hopkins:
Okay, great, thank you. I’m sorry if I missed that in the slide or something. So the two things I really wanted to focus on was one, on the remediation supply side, your pushing back your guidance for when you think it will be completely behind you. What is the one main reason why you are doing that? One main reason for the adjustment and can you quantify what you think the supplier issue, how much its impacting growth right now?
Dan Florin:
You know Bob as I said in my prepared remarks, the production output in the third quarter fell below our expectations, which means we did not make progress on reducing the backorder that we expected to, and really as I said, the drivers being a level of process inconsistency in certain core manufacturing or complex manufacturing processes, as well as the increased attrition in the temporary workforce. So a combination of those two factors led to the shortfall in [Audio Gap] production output. So I described what we’re doing about that and in terms of the impact of that on the Q4, you know the point I would make is that our prior Q4 guide assumed we’d be entering the quarter in a healthier supply situation and we had order of magnitude 200 to 250 bps of comp adjusted acceleration in the fourth quarter, really predicated on the assumption of having the supply to go on offense. So that’s the biggest driver of the takedown in Q4.
Bob Hopkins:
Okay, I’m sure someone will follow-up on the attrition question, but I wanted to get your views on the U.S. hip and knee market. Most of the folks that have reported so far has seen a little bit of weakness, but your calling out a couple of specific things and reasons why you think the market is slower and I was wondering if you could just develop that a little bit more, because some of the growth rates we’re seeing are you know growth rates that are, the week as its seen in sometime. So could you just kind of go in a little more detail on what you think is going on with the U.S. hip and knee market. Thank you.
Dan Florin:
Sure. So based on what’s been reported we estimate the Q3 U.S. knee and hip market was somewhere between flat to 1% on a day adjusted basis in Q3, which was below our expectations. Our expectations had been more in the 2% to 3% range. Q3 is always the slowest from a seasonality perspective and has been the least predictable over the past several years. So we view this as more of a quarter-to-quarter demand dynamic as opposed to any systemic change in the outlook for hip and knee performance and market growth in the U.S. So we continue to believe that 2% to 3% global knee and hip market growth rate is sustainable and you know based upon underlying demographics. So we’re not concerned about the ebb and flow quarter-to-quarter. We still believe in the long term tail of demographics and 2% to 3% global U.S., global hip and knee market growth rate.
Bob Hopkins:
Okay, great. Thank you very much.
Operator:
Our next question comes from Mike Weinstein with JPMorgan.
Mike Weinstein:
Thank you, and maybe I’ll just pick up of where Bob left off there. So the comment in the prepared remarks about U.S. insurance dynamics impacting the end market growth, what are you referencing there?
Dan Florin:
Well, I think it’s just what we’ve seen Mike is a lot of volatility quarter-to-quarter and I am referring to you know the higher prevalence of high deductable plans, which tends to cause people to have elective procedures on later in the year. It’s just more difficult to predict. I don’t think we have enough data points.
Mike Weinstein:
This is nothing, but [Cross Talk] impacting the third quarter.
Dan Florin:
That’s correct.
Mike Weinstein:
Okay. And then could you spend Dan just a couple of minutes on the dual sourcing strategy and what you’re doing there?
Dan Florin:
Sure. So I’m referring to a number of more complex manufacturing processes that are in the North Campus, where despite a lot of excellent work by the engineers and that work continues, it’s obvious that we need more capacity on these particular production lines. For obvious reasons I don’t want to get into the weeds on what exactly those processes are, but in fact what we are doing in addition to optimizing inside the four walls of the North Campus, which we’ll continue to do, we’re also looking on the outside, a combination in our current network or with vendors, they add capacity for those particular production activities. So that’s what we mean by dual sourcing. So we’re accelerating that timeline to look for additional capacity that we need and that increased capacity should also as we continue to make improvements on the processes lead to more process and output consistency.
Mike Weinstein:
Okay, and then last item on your comment on the CEO search, I recognize there is a limitation just to what you can say. You wanted to add anything relative to your thoughts on timing?
Dan Florin:
No Mike, I would just say that you know as you can appreciate, I am not going to provide specific detail on the board’s process, just that the process is ongoing and our board continues to make good progress and as we’ve always said, we’re committed to a thorough and timely search process.
Mike Weinstein:
Understood, thank you.
Dan Florin:
You’re welcome.
Operator:
Our next question comes from David Lewis with Morgan Stanley.
David Lewis:
Good morning. Dan you just – a few quick ones here. Just starting this kind of fourth quarter guidance and getting a sense of how conservative you think that number is, it still implies by our math some acceleration in the momentum in the business into the fourth quarter and that has not happened in several quarters. So can you just give us a sense of what drives that underlying momentum acceleration into the fourth quarter and I have a couple of quick follow-ups.
Dan Florin:
Well as I said before David, the prior guidance assumed much more significant acceleration predicated on full supply. What our Q4 guidance is not assuming is any of the Q3 market softness spilling into the Q4. In other words, our Q4 guidance is assuming a U.S. hip and knee market based upon historical seasonality Q3 to Q4, so we’ve not layered that expectation on top. So I think the underlying guide in Q4 is assuming similar production levels to Q3, a market that’s tied to historical seasonality and the type of progress on these non-affected brands that I described in my prepared remarks. In other words we are making progress on certain products coming out of the North Campus, which helps – put that in the hands of the sales force to drive some growth and then the last part would be, you know we’re very excited about the Persona Partial Knee and that will continue to have impact in the ensuing quarters.
David Lewis:
Okay, but if the market does not get better in the fourth quarter, this guidance theoretically could be at risk, said another way.
Dan Florin:
Well, our assumption about the U.S. hip and knee market for Q4 is a 2% to 3% type year-on-year market growth.
David Lewis:
Okay, that’s very helpful. And then Dan, just two questions around earnings. The first question is cost dynamics in the quarter. If I take your revenue reduction for the fourth and I assume a pretty good drop through, you know you get kind of – you know $0.20 is the reduction for the fourth quarter roughly. I get kind of half that from a high margin product sales drop through. Is the other half coming from the cost of higher employee wages to keep them in their seats and the dual sourcing? Is that a decent way of thinking about it. It’s sort of half increased cost and half about the top line drop through.
Dan Florin:
You know the drop through on the sales is more than what your modeling, you know because the take down from the prior guidance is focused on the U.S. market, so that EBIT drop through on the mix of sales is more significant than the half that your describing. You know I’d probably put of the takedown between the organic sales and the FX change. You know inclusive of the mix I just described that’s about in the neighborhood of $0.12 of the take down and the balance being tied to incremental cost of goods, the combination of higher production costs and inventory charges tied to the North Campus performance.
Matt Abernethy:
Let me clarify the organic component of the take down David is around $65 million, but the offset of the FX benefit around $20 million.
David Lewis:
Okay, that’s very helpful. And then Dan I know its early, but if we think about it, there’s a lot of consternation about what the 2018 could be last quarter and is it a decent way of thinking about next year? Do you still believe this business; you know A can grow modestly in 2018. Can you leverage the business growths 1% next year? Is that a decent way to think about core earnings growth? One way I am thinking about it is if the core business grows 1%, you lever earnings 1% and you get currency, you kind of come out at $8.20, $8.30 for next year. I just wondered if you just think about how this business can grow over the next 12 months. Thanks so much.
Dan Florin:
You know David, I’d say that we are going to provide 2018 guidance in early 2018. We have to see how the year closes and then go through our normal process, taking into account production, sales trends, gross margin etcetera and the investment needs and form thoughts more fully on 2018. I think it’s important to point out that gross margins will continue to be pressured until we increase our U.S. sales growth and optimize the production of the products that are currently produced in the North Campus. So we have planned to do both of those things, but in terms of the gross margin profile, you know if you look at the gross margin profile in the back half of this year as revised, I think that’s the right way to think about gross margin rate for next year. We’ll continue to drive value creation programs across the enterprise. First and foremost top line growth is at the top of the list.
David Lewis:
Okay, thank you very much Dan.
Dan Florin:
You’re welcome.
Operator:
We’ll go to Chris Pasquale with Guggenheim.
Chris Pasquale:
Thanks, good morning. Alright Dan, you never mentioned the close of the deals during the quarter but the legacies in your portfolio continues to struggle a bit there. How close do you think we are seeing that segment turnaround? Is it just a matter of lapping the impact of some rep turnover or do you need something else like new product flow to get it going in?
Dan Florin:
Sure Chris. You know first we’re very excited and continue to be very excited about the Mobi-C product line. In addition we expect the recent enhancements to our vitality system and the future robotic spine application to be key enablers to future spine momentum. Certainly the recent results have been impacted by the market on the one hand, but probably more so the sales disruption and the channel integration. So you know at this point in time we continue to evaluate and I would say fine tune our sales structure to make sure that we’re positioned for long term spine success. I think we have the portfolio that we need. We have a lot of talent in the sales channel and we’re going to continue to look to fine tune that and make sure that we’re getting that type of performance that equals the potential that we have.
Chris Pasquale:
Okay. S.E.T. was such a bright spot last year and has taken a couple of steps back. I know that the Warsaw North issues are a big piece of that. But can you talk about the outlook for the business heading into next year and maybe in particular focus on that stem of shoulder launch. How that compares to the competitive product that’s on the market today and how you think about that market opportunity?
Dan Florin:
Sure. So year-over-year growth slowdown was attributable to more difficult comps, but also really for the first time seeing the cumulative impact on momentum due to supply constrains. So we’ve been describing that from the North Campus. There is certain Biomet Sports Medicine, upper extremities and trauma products that come out of the facility. Importantly Chris S.E.T. remains a strategic growth driver for the company. It’s a very important exciting market for us. We’re clearly focused on improving supply first and foremost in shoulders, sports med and trauma. We’re continuing to invest in specialized sales forces in the S.E.T. category. I think the results of surgical are an excellent proof point of what that can do from a performance perspective and then you’re right, the launch of the new products in 2018, that includes the Stemless Shoulder, as well as the Comprehensive Augmented Baseplates. So you know we’re the market leader in shoulders and getting the Comprehensive Augmented Baseplates out into the markets, an important addition, and we’re very excited about the Stemless Shoulder. We think that’s going to compete very nicely with the other stemless products that are out in the market. Next question.
Operator:
We’ll take our next question from Kristen Stewart with Deutsche Bank.
Kristen Stewart:
Hi, thanks for taking the question. Just going back to the gross margin question and gone looking ahead to 2018, how long do we think that or how long do you think that the gross margins will continue to be pressured by some other costs?
Dan Florin:
Kristen, sure, sure. The gross margin pressure, the two contributors here in 2017 relative to prior guidance are the sales mix that I was describing earlier, less U.S. sales than expected and then secondly the production costs and related inventory costs out of the North Campus. So the sales mix will improve as we accelerate U.S. growth. The cost of goods from the North Campus as I described is going to persist through 2018 and frankly until we’re, as I described, until we’re into a more automated environment with validated processes and more process consistency in combination with the added capacity. Those are the elements that are needed really to drive improved costs and more consistent output.
Matt Abernethy:
And to add on that, you know our expectations on what we have communicated previously, that program and the positive benefit on gross margin would start translating into benefit in 2019 and 2020.
Kristen Stewart:
Okay, and I appreciate you don’t want to give any sort of color on 2018 in terms of the specific guidance, but are there any other puts and takes that you can give us just to help frame 2018 at this standpoint?
Dan Florin:
Kristen as I said, I really want to see how we close Q4, see what kind of momentum we have exiting the year and then monitor the progress that we’re making on our dual sourcing strategy and the engineering improvements inside the North Campus. That will inform our view on production output, which is so critical to getting full supply into the hands of our great sales force to drive growth. So I’d rather wait until our guidance early next year.
Kristen Stewart:
Okay, that’s fair. Thank you.
Dan Florin:
You’re welcome.
Operator:
Our next question comes from Steven Litman with Oppenheim.
Steven Litman:
Thanks. Hi guys. First of all, I was wondering if you could just frame for us about what percent of the recon business falls into the more complex products that are still supply constrained versus those that you feel that you are in a better position from a supply perspective?
Dan Florin:
Steve I – you know without getting into the exact quantification of that, I would tell you that a lot of the brands that come out of the North Campus, which of course is you know a Biomet facility, a lot of those brands were in fact faster growing product lines and it stands knees, hips, sports extremities and trauma. So it’s a significant facility for Zimmer Biomet. The complex processes without getting into the weeds on what those exactly are do impact a significant number of those brands and I think that the quantification of that is apparent in the impact it’s having on our performance and our revised guidance.
Steven Litman:
Okay, got it. And then Dan just a couple of products for next year. Can you talk to how much you think not having cementless has also impacted knee growth and how that may be important for the back half of next year? And then I know on Rose, obviously a lot of talk about getting into knees, but you’re not really fully rolled out in spine yet. Is that also targeted for mid to back half of next year?
Dan Florin:
Sure. We’re very excited about the pipeline for 2018 and we’re excited about what percent of partial knee will do for us in 2018, we’re excited about getting the cementless Persona out and we’ve had a competitor talk about cementless being as much as 20% of their knee mix that comes at a nice price point, so we’re very excited about getting that out into the market middle of next year and we think that product will perform very well and then we’ve also talked about getting the Persona revision system out into the market. So a lot of really important Persona product launches next year. On the ROSA side we’re on the knee application. Continue to make progress in accordance with the timeline that we’ve described before and then keep in mind that the Medtech where the platform is currently approved for brain and you know we’re very excited about that opportunity. So our craniomaxillofacial business, which is one of our best performing divisions in the company continues to drive good growth. It’s under very capable leadership and that same leadership is overseeing the brain and spine ROSA development program. So on the ROSA Spine, the expectation is middle of next year to be out in the market. We think that product and application will compete very favorably with the other spine robotic systems that are currently in the market.
Steven Litman:
Okay, thanks Dan.
Dan Florin:
You’re welcome.
Operator:
Our next question comes from Matt Taylor with Barclays.
Matt Taylor:
Hey, good morning, thanks for taking the question. I guess the first thing I wanted to circle back on was when you are talking about normalized 2% to 3% market growth here in Q4, can you comment on whether you are seeing that through the first month of the quarter or are you seeing any continued insurance dynamics or other soft spots that would cause the Q4 market growth to be lower?
Dan Florin:
Matt, our 2% to 3% U.S. market assumption is based upon historical norms. So what I was describing before is that we stuck with that assumption about the market and did not add on top of that the softness in Q3. So I’m not going to comment on inter-quarter months, but I’d say at this point the 2% to 3% U.S. knee and hip growth is the right way to think about it based on historical norms.
Matt Abernethy:
And just to add to that Matt is usually the big bowl of some procedures pushes into November and December, so near term read is obviously difficult, but there is no indication that we are aware of that, that’s pointing to something other than what we communicated.
Matt Taylor:
Okay and then when we think about the improvements that you can make going forward to your ability to produce some of these key brands, you talked about 2Q ’18 as being really the turning point when you’d be able to have full supply. So can you just clarify it, does that mean that if you are going to really take until the third quarter for you to go back fully on offence or can we see that kind of early in the second quarter? I just wanted to get little bit more specific on the timing.
Dan Florin:
Yeah Matt, from a timing and recovery perspective, it’s a rolling recovery okay. So during Q4 here we’ll be making continued progress on certain brands; Q1, Q2 we’ll continue to make progress and that incremental progress is critical and meaningful, because what means is that our sales force can then gradually move away from being the case logistics people that they have been to more higher trust that the products will be there and then going on offence and not only servicing existing accounts, but going after new business that we know is out there for us. So it’s a rolling improvement. Some brands will continue to get healthy through Q1. My comment about Q2 was in the vein of having full supply ready to go on offence across all brands with our engineering improvements and duel sourcing strategy contributing to that pace of recovery. So you know, that’s the comment relative to Q2 and that sets us up well for thereafter.
Matt Taylor:
Okay, thanks very much guys.
Operator:
Our next question comes from Kaila Krum with William Blair.
Kaila Krum:
Hey guys, thanks for taking our questions. First, I got this to start off; what percentage of your surgeon customers today would you say are waiting on the sidelines sort of prior to a complete supply recover here? Is it 20%, is it a third, is it as much as half; just any sense for that would be helpful.
Matt Abernethy:
Sure. You know I spent a fair bit of time in the field over the past quarter and continue to be impressed by the talent of our sales force, the belief of our sales force and our surgeons with respect to Zimmer Biomet. That’s critical and gives me confidence that over time as supply recovers, that we are going to get the accelerated growth that we know is out there and I’m confident that we are going to deliver on that. It is the case that surgeons are frustrated. They believe in Zimmer Biomet, they believe in their sales rep and you do have instances where we are able to fully supply surgeons and it is the case that you have other surgeons that are sitting on the sidelines waiting for the full range of SKUs available across our product family before they entrust their business act to us. So that’s where our focus is. I’d also add that the lack of full supply tampers our ability to bring on new surgeons at the top of the funnel so to speak. So we know the ticket is full supply, that’s why we are focused on it and as that supply picture improves I have no doubt that our sales team will run with that and make good progress.
Kaila Krum:
Okay, thanks, that’s helpful. And I guess just, you said we are going to reach supply stability by the end this year with a portion of the products and the rest by the second quarter of ’18. I guess what sort of visibility do we have into that recovery at this time, and what gives you confidence in that statement made?
Dan Florin:
Well, with the guidance takedown that’s embedded in our Q4, it tells you that production is the biggest barrier. So our assumption about production output for Q4 is that production is similar to Q3 levels and what gives us confidence on the recapture, which again is more of a exiting this year and gradually through next year, is tied to what I was describing before in terms of the interactions with surgeons and our sales force and their beliefs in the portfolio. So we know what we need to do. Its tied to production of the North Campus, but it’s also you know our team is executing very well with Persona and I mentioned good growth in the quarter on Persona; I mentioned the educational event that we did on Person where we had hundreds of surgeons attending that, demonstrating the versatility of both the implants and the instrumentation of Persona. So I know that our sales team is going to make a lot of progress with the Persona platform. And then on the production side of the house, the key is really as I described process consistency. So reducing the variability in those processes, getting redundant capacity out to either vendors of elsewhere in our network as duel source capacity; that’s a combination of those two areas.
Kaila Krum:
Thanks guys.
Dan Florin:
You’re welcome.
Operator:
Our next question comes from Matthew O'Brien with Piper Jaffray.
Matthew O'Brien:
Thanks for taking the question and good morning. Just for starters on the guide down for Q4 by my math, you know net of currency its about $40 million guide down. I’m assuming a majority of that is related to these complex products that you can’t manufacture. So first of all, is that math about right and then secondly, is that roughly what we should expect in Q1 as far as the headwind that would will face in that business, maybe tapering down a little bit and then tapering down even more into Q2 next year.
Dan Florin:
So Matt, the Q4 takedown, you have the right net number. I think organically the number is north of that. The organic takedown as Matt mentioned before is more like $65 million with some favorable currency in the range of $20 million. So it’s the organic takedown is north of the 200 basis points. And you know I’d say the organic take down of 300, call it, call half of that being tied to supply and lack of offence. We also had dialed in Q4 guidance, prior guidance and acceleration in spine and as I mentioned before, we’ve removed that from the guidance based on current performance as we need to drive improved performance in the sales channel and then to a lesser extent the impact being the India knee price, which we expect that to be a drag on Q3 as well.
Matthew O'Brien:
And as the manufacturing push out goes, Dan how comfortable are you with you know the timeline that you’ve laid out now of Q2 next year being you know completely finished with this issue and how, you know all inclusive or how broad is the plan that you put in place to ensure that that will be the definitive moment where all this issue is behind you from a production perspective, be it the duel sourcing etc. and then how does FDA fit within that timing?
Dan Florin:
Well Matt, we as I said in my prepared remarks, we continue to make good progress on the quality remediation in the North Campus. So we are very much on track with the remediation plan that we laid out for the FDA at the end of last year. So we feel really good about our progress there. You know it’s been roughly a year since the FDA inspected the facility. We don’t know exactly when FDA will come back in, but we will be prepared for them when they do. With respect to the production recovery and the timeline, you know operating this plant under the manual interim process control environment leads to greater variability and inherent risk that’s associated with the output and it is what it is. What I am confident about is that the engineers are focused on the right areas for improvement. We brought in technical experts from the outside to help in that regard and we are also working closely with outside vendors who have certain capabilities, speculative confidence that they are going to be able to help drive that added capacity. So that’s what gives us the confident to lay out the timeline that I just laid out Matt.
Matthew O'Brien:
All right, thank you.
Dan Florin:
You’re welcome.
Operator:
Our next question comes from Bruce Nudell with SunTrust Robinson Humphrey. Bruce, we are unable to hear you. Please check your mute function.
Bruce Nudell:
Hi Dan, could you hear me know?
Dan Florin:
Yes Bruce, good morning.
Bruce Nudell:
Yeah, good morning. You know post the Zuk divestiture, you had about 39% just in share. It looks to be about 36% now. Just given any lingering issues with supply that caused permanent customer defections, and perhaps sales force defections as well as a lack of a robot, where do you think you guys will add some tone, and you know how much of that is due to the lack of a robotic solution?
Dan Florin:
You know Bruce I would say that based on the early, well both the limited release and now the full release of the Persona Partial Knee systems, we are extremely confident in that platform and I personally talked to surgeons who have used the makeover for Uni Knees and are excited to use the Personal Partial Knee system. Those are surgeons that have had excellent success with the Personal Primary System and our excited about using the Personal Partial Knee. So we believe that we will win back market share that we lost as a result of this divestiture.
Bruce Nudell:
And you know but just more broadly, where do you think you know knee share will stabilize and where will you kind of – how much of that 39% did you get back.
Dan Florin:
Well our efforts, you know we have internal goals to recover all of the loss business of Zuk. We have again – the feedback is very positive on the Persona Partial Knee. So as we have full supply across all of our knee systems, we are in a good spot with Personal Primary, but as we get healthier on Vanguard and as we launch the cementless Persona and the Revision knee, our goal is to first and foremost get back to market growth. You know we’ve been seeding share; that needs to stop. Supply in the pipeline into the hands of the sales force will enable that and first and foremost we are focused on closing the gap to market, then putting up a string of quarters at market growth and then above market growth thereafter. So it’s a whole string of things that we know we need to execute on better and that will lead to market share gains.
Bruce Nudell:
And I guess my follow-up is, you know this is the first time I’ve heard the company talk about expectations for the worldwide major joint market at 2% to 3%; it was always closer to 3%. I’m sure that wasn’t taken lightly, and how does the impact the boards perceptions, the necessity to move away from hips and knees?
Dan Florin:
Well, to win Bruce for Zimmer Biomet we need to perfume in hips and knees and that, you know our performance in hips and knees in the Asia Pacific region has been excellent and that performance in Asia Pacific is really driven by the team and they’ve not been as dependent on the North Campus products as much as the U.S. markets. But the team has done extraordinarily well and we expect them to continue to do so. The EMEA growth in the quarter for knees was quite good. So the 2% to 3% I would just tell you that we are still of the belief this is an attractive market. The demographic tailwinds are real, so we are committed to growing hips and knees. For us to win, we need to perform really well there. At the same time, we’ve talked a lot about the S.E.T category; you know 21% of our sales mix today, why we are very excited to continue to perform there. It was hampered by supply this quarter, that will improve over time and we’ll look to continue both organically and inorganically to add to the S.E.T bag. It’s a critical driver for us and last piece being spine, so my comments about spine and our potential to drive accelerated performance there. So it’s really across the portfolio where we need to perform.
Bruce Nudell:
Thanks so much. Bye.
Dan Florin:
All right Lauran, we have time for one last question.
Operator:
We’ll go to Joanne Wuensch with BMO Capital Markets.
Joanne Wuensch:
Thank you very much for talking the question. Could you qualitatively discuss what’s going on with the sales force? How you are thinking about keeping them in place motivated and making sure that they see there is a turning point in this process?
Dan Florin:
Absolutely Joanne. I mentioned the amount of the time that I’ve personally been spending in the field and that includes direct time with our sales leadership for the orthopedics business and as well as a good piece of our spine sales force. So in a nutshell, we continue to post them regularly on the updates with respect to supply. On top of that, we are placing a tremendous focus on all of our team members on supporting our sales channels globally. I think importantly we’ve seen relatively stable levels of attrition; so a net neutral performance from a headcount standpoint of the channel in the United States here in Q3. So I think that is indicative of a sales force that continues to believe in Zimmer Biomet, continues to believe in our products and our pipeline and a lot of high touch with them and communication will be necessary as we continue to move forward. So I believe we got the best sales force in the industry. We need to fully equip them with all the tools they need to win, that’s where our focus is.
Joanne Wuensch:
Thank you and as for my second question, it’s going to sound so mundane given everything going on. SG&A was nicely down as percentage of revenue year-over-year. Are there still expense synergies to be had by the combination of these two companies?
Dan Florin:
Joanne, we’ve described here in 2017 synergies in the neighborhood of $225 million, and leading to $310 million cumulative, okay. So you know that, the integration synergies are on track through 2017. So as I described we’ll continue to look at other value creation opportunities across the enterprise. We know that first and foremost it starts with top-line performance and acceleration. And then last bit on SG&A, you know our SG&A percentage includes the depreciation of our instrument placements, which is part of obviously a growth investment for us, so we continue to invest in the working capital and instrumentation necessary to drive growth.
Joanne Wuensch:
Okay, thank you very much.
Dan Florin:
So, thank you everyone for your attendance today and we look forward to speaking with you on the fourth quarter call. Thank you.
Operator:
Thank you again for participating in today’s conference call. You may now disconnect.
Executives:
Matt Abernethy - Vice President, Investor Relations and Treasurer Dan Florin - Interim Chief Executive Officer and Chief Financial Officer
Analysts:
Bob Hopkins - Bank of America Matt Taylor - Barclays Mike Weinstein - JPMorgan David Lewis - Morgan Stanley Joanne Wuensch - BMO Capital Markets Richard Newitter - Leerink Partners Larry Biegelsen - Wells Fargo Glenn Novarro - RBC Capital Markets
Operator:
Good morning. I would like to turn the call over to Matt Abernethy, Vice President, Investor Relations and Treasurer. As a reminder, today’s call is being recorded. Mr. Abernethy, you may begin.
Matt Abernethy:
Thank you. Good morning and welcome to Zimmer Biomet second quarter 2017 earnings conference call. I am here with our Interim CEO and our CFO, Dan Florin. Before we start, I would like to remind you that our discussions during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties. Also, the discussions during this call will include certain non-GAAP financial measures. Reconciliation to these measures to the most directly comparable GAAP financial measures, are included within the earnings release, which is available on our website at investor.zimmerbiomet.com. With that, I will now turn the call over to Dan.
Dan Florin:
Thanks, Matt. Before I discuss our results for the quarter and outlook for the remainder of the year, I want to take a minute to thank David for his contribution to Zimmer Biomet for the past 16 years. During David’s tenure, the company became a global industry leader and made tremendous progress, establishing a world class portfolio of technologies, solutions and personalized services and we wish him success going forward. I am honored to serve as interim CEO as well as by this opportunity to lead such a talented and dedicated team. Since stepping into this role, I have been closely engaged with Zimmer Biomet’s board, the management team, commercial leadership and other team members across the organization. While we have a lot of hard work ahead, I am encouraged by the team’s commitment to ensuring that we capture the promising opportunities in front of Zimmer Biomet. With respect to the CEO search process, the board has retained a leading executive search firm to identify and evaluate external candidates for the permanent CEO role. That process is ongoing and the board is committed to moving diligently and swiftly. I have communicated to the board that I am committed to leading the company in the interim capacity as long as necessary. During the second quarter, we achieved net sales of $1.945 billion, an increase over the prior year quarter of 1.1%, which included approximately 240 basis points of contribution from the LDR acquisition. Our results were negatively impacted by approximately 100 basis points as a result of having 1 less billing day during the quarter. On a constant currency basis, net sales increased 2.1%, including a solid 6.8% sales increase in our Asia-Pacific geography and 2.5% sales growth in the Americas. Our continued strong growth in the Asia-Pacific region was the result of focused commercial execution and a historically low level of product mix out of the Warsaw North Campus. Our sales in the Europe, Middle East and Africa region decreased 1.8% on a constant currency basis compared to the prior year quarter. However, we recorded positive growth on a selling day adjusted basis. As we have highlighted previously, there are two primary factors that contributed to top line results being below our expectations. First, production delays within certain key brands impacted our ability to reduce back orders at the targeted rate. Second, sales recapture from previously affected customers in the United States was impacted by our delayed production output. As a consequence of lower than anticipated second quarter results as well as updated assumptions on production levels and sales recapture, we are revising our 2017 sales and earnings guidance, which I will detail later in my remarks. I would like to now spend a few minutes providing more detail on our key focus areas to address these challenges going forward as well as some of the initiatives already underway. During the quarter, we delivered production consistency with significantly less disruption than we saw in the first quarter. Notably, we delivered the highest quarterly output on record from our Warsaw North Campus manufacturing facility, allowing for some of our brands to achieve the full production levels that we had previously anticipated. However, reaching full production of certain brands has proven to be more challenging than initially anticipated due to the complexity of validating certain material types and production processes as well as ensuring quality control with regard to sourcing. This resulted in lower than anticipated supply availability of these brands during the second quarter and we have therefore updated our expectations for the second half of the year. We continue to make progress meaningfully reducing back orders on many of the brands manufactured at the Warsaw North Campus and we expect to continue building safety stock of these products through the third quarter. For those brands that were delayed in the second quarter, we anticipate that we will substantially reduce back orders through the third quarter and early into the fourth quarter. Importantly, we expect to reach sufficient safety stock levels across our entire portfolio as we exit 2017. Clearing back orders allows us to more fully meet the existing customer demand and we expect that achieving sufficient levels of safety stock will enable us to return to greater sales offense and bring on new customers. While we are disappointed that the timeline for recovery of certain product lines has extended beyond our initial expectations, our cross-functional teams continue to execute well and we are focused on restoring adequate supply in line with these new timelines. We continue to more broadly invest in manufacturing and quality enhancements across our entire network and I will address these investments in further detail when I review our financial performance and guidance. Now, turning to our sales recapture program, on prior calls, we have discussed headwinds associated with our ability to fully meet existing customer demand. These same factors carried into our second quarter. We still see an opportunity to recapture this business, but we expect that this will occur at a slower pace than previously anticipated as a result of the supply delays that I have described. We have established focused initiatives to deeply engage with our customers, sales forces and team members in order to more fully meet existing customer demand. Fully restoring product supply is the first step in this process, with enhanced commercial execution and customer engagement being the other key elements to our renewed growth program. We continue to make investments in and offer incentives to our sales forces and commercial team, enabling us to work closely with our customers and prioritize growth opportunities as we progress through the year and into 2018. Our global sales forces and team members have shown tremendous resiliency through these past several quarters and I am proud of their collective efforts. I can assure you that we are not going to stand still waiting for our new CEO to arrive. We know what we need to do and we have an incredibly talented team that wants to win. As we look forward, the clinical heritage of our products, our strong innovation pipeline and our best-in-class sales forces gives the board and our entire management team confidence in the promising opportunities in front of Zimmer Biomet. As I will discuss in a moment when I walk through our business results, we have delivered ongoing, market leading growth in the Asia-Pacific region and we have substantially completed our commercial integration with LDR Spine, both of which reinforce our confidence in the fundamental strength of our global business. We are confident in our ability to remedy recent challenges and are eager to get back on the offensive and do what we do best. As we continue to work through this process, we are approaching our challenges head on to ensure we get back on the right track. During the second quarter, we continued to observe steady market demand across the globe. With regard to pricing, we experienced negative pressure of 2.6% during the second quarter. The slight sequential increase in pricing pressure from the first quarter to the second quarter was attributable to certain markets in the Asia-Pacific region. Before I review our performance by category, I will remind our listeners that as previously mentioned our net sales were negatively impacted by approximately 100 basis points, resulting from 1 fewer billing day during the quarter. Our knee net sales decreased 1.3% from the prior year quarter, reflecting positive volume and mix of 1.5% and negative price of 2.8%. While we continue to achieve solid results in the Asia-Pacific region, supply challenges hampered our growth in the Americas as well as in the Europe, Middle East and Africa region. By focusing on fully restoring product supply of certain brands manufactured at our Warsaw North Campus, along with the further development of our strong product pipeline, we are positioning the company for improved knee performance. During the quarter, our limited launch of the Persona Partial Knee received excellent early clinical feedback from surgeons. We expect to begin the full commercial launch of this product later this quarter. We have also continued to execute our Persona TM Tibia cementless knee and Persona revision development projects with initial launches expected in the second half of 2018. In support of our flagship total knee brands, during the quarter, we announced the commercial availability in certain European markets of our X-PSI guides, the world’s first CE Mark surgical planning system that enables patient-specific implant positioning using a guide that is manufactured from 3D anatomic models generated from x-ray images. Importantly, this next generation system offers economic value in health care by replacing MRI and CT scans with standard x-ray technology. Turning to our hip category, our sales decreased 0.2% from the prior year quarter, reflecting positive volume and mix of 2.4% and negative price of 2.6%. We continue to see strong demand for the G7 Acetabular system, including our proprietary 3D printed OsseoTi Porous Metal Technology, as well as the Taperloc Complete Hip Stem and Arcos Modular Femoral Revision System, although these positive trends were offset primarily by supply shortfalls at the Warsaw North Campus. Additionally, we have received regulatory clearance in the U.S. to market our clinical graphics technology for femoroacetabular impingement. This platform enhances our hip preservation portfolio with 3D range of motion simulation software designed to inform treatment decisions. Turning to our S.E.T. product category, we delivered 3.6% year-over-year sales growth. This performance was driven in large part by our surgical business and sports medicine offerings such as Gel-One, Subchondroplasty and Quattro Link, as well as our A.L.P.S. Plating System within our foot and ankle portfolio. Our growth was partially offset by supply constraints on certain product lines. Fully restoring product supply remains a key priority, along with continued expansion of our specialized sales channels. Our second quarter dental sales decreased 5.7%, primarily due to headwinds in certain European markets where we restructured our dental sales organizations for long-term success. Importantly, we had positive dental sales growth in the United States during the quarter. We also recently appointed a new General Manager to lead our Dental business. Together with our focus on enhanced product positioning, targeted commercial strategies and strong execution, we believe that we will be better positioned for improved performance in this attractive market. Turning to our spine, craniomaxillofacial and thoracic category, sales increased 33.5% during the quarter. As in recent quarters, we continued to benefit from strong demand for the Mobi-C Cervical Disc. With the integration of our U.S. spine sales force now substantially completed, we expect to begin capitalizing on the significant cross-sell opportunities that the LDR combination provides. Among our craniomaxillofacial and thoracic offerings, we achieved another strong quarter of growth. We continue to be pleased with the ongoing sales of our SternaLock Blu and SternaLock 360 primary closure systems as well as the RibFix Blu Thoracic Fixation System. I will now turn to our other second quarter financial details before providing additional information relating to our third quarter and full year 2017 sales and earnings guidance. Our adjusted gross profit margin was 74.3% for the quarter and was 70 basis points lower than the prior year period, due primarily to the impact of price declines, additional manufacturing costs at our Warsaw North Campus manufacturing facility and lower gains from our cash flow hedging program, particularly associated with the Japanese yen and the euro. Our R&D expense was 4.6% of revenue at $90.1 million, consistent with the same period in the prior year. As previously highlighted, we continue to prioritize R&D spending on what we believe are the most impactful programs, including our important knee programs, robotic applications and Zimmer Biomet Signature Solutions, among others. Adjusted selling, general and administrative expenses were $748 million in the second quarter or 38.3% of sales, 50 basis points higher than the comparable period in the prior year. The negative variance was driven by a full quarter impact from our 2016 strategic acquisitions, including LDR, Medtech, CD Diagnostics and others, which negatively impacted SG&A expense by 60 basis points. We also incurred higher freight costs in the quarter due to expedited product shipments and continued investments in our specialized sales force. These increases were offset in part by continued savings in various SG&A expense categories stemming from synergy capture initiatives. In the quarter, we recorded pre-tax charges of $331 million in special items, which include $192 million of non-cash amortization, inventory step-up and in-process R&D impairment charges, as well as $54 million of quality remediation expense and $85 million of integration expense and other items. Our diluted earnings per share for the quarter were $0.90 versus a loss of $0.16 in the prior year period. Adjusted second quarter 2017 figures in the earnings release exclude the impact of the special items that I just mentioned. Adjusted operating profit in the quarter amounted to $613.5 million or 31.4% of sales which was 120 basis points lower when compared to the prior year period. Our adjusted effective tax rate for the quarter was 19.5%, a decrease of 520 basis points from the second quarter of 2016. The second quarter tax rate was consistent with previous quarter’s guidance and is primarily due to the favorable resolution of various tax matters, which will have future benefits on our effective tax rate. Adjusted net earnings increased 4.3% or 9.7% excluding the impact of foreign exchange to $424.6 million for the second quarter. Adjusted diluted earnings per share for the quarter increased 3% over the prior year period or 8.4% excluding the impact of foreign exchange to $2.08 on 203.7 million weighted average fully diluted shares outstanding. A reconciliation of reported net earnings to adjusted net earnings is included in this morning’s press release. Operating cash flow for the quarter amounted to $440.5 million, which reflects $120 million of cash expenditures for our synergy program and quality remediation initiatives. Capital expenditures for the quarter totaled $116.9 million, including $86.2 million for instruments and $30.7 million for property, plant and equipment. Our free cash flow in the second quarter was $323.6 million, which was $63 million higher than the second quarter of 2016. During the quarter, the company retired a $500 million senior note, which matured in early April. Additionally, we fully repaid the $400 million drawn from our senior credit facility that had been previously used to bridge our senior note retirement. Therefore, when combined with our first quarter activities, gross debt reduction during the first half of 2017 was $650 million. I’d like to now turn to our updated guidance. As a result of the previously described manufacturing remediation efforts related to certain brands manufactured at our Warsaw North Campus facility, as well as slower than expected sales recapture, primarily in the U.S., we are adjusting our third quarter and full year revenue and earnings outlook. For the third quarter, we expect revenues to be in the range of $1.815 billion to $1.845 billion, which reflects a negative impact from foreign exchange of 0.5%. On a constant currency basis, our growth rate is expected to be in the range of negative 0.5% to positive 1.0% inclusive of a 30 basis point contribution from the LDR acquisition, as well as an approximately 130 basis point negative impact from fewer billing days when compared to the prior year period. Therefore, our billing day adjusted growth rate excluding the contribution of the LDR acquisition is now expected to be in the range of 0.5% to 2.0%. This compares to 0.7% in the second quarter. Regarding the fourth quarter, based upon our current expectations for supply recovery and timing of sales recapture, we are anticipating a billing day adjusted growth rate in the range of 1.0% to 3.0% over the prior year period. Note that the projected weighted average billing day impact on our fourth quarter growth rate is a favorable 20 basis points and that we fully anniversary out of the LDR acquisition during the third quarter. Current foreign exchange rates would have a favorable impact of 80 basis points in the fourth quarter. Therefore, for the full year 2017, our estimated revenue growth is now expected to be in the range of 1.5% to 2.4% over the prior year. Foreign exchange is now expected to decrease revenues by 0.3%, a 90 basis point improvement from previous guidance as the dollar has weakened versus many currencies. Taken together, constant currency revenue growth over 2016 is expected to be in the range of 1.8% to 2.7%, inclusive of 120 basis points of acquired revenue from the LDR acquisition. In dollar terms, our full year 2017 revenues are expected to be in a range of $7.800 billion to $7.870 billion. Our expected dollar range is down from our previous guidance range of $7.835 billion to $7.915 billion, with favorable foreign exchange partially offsetting the reduction in our constant currency growth rate. Turning to projected full year 2017 earnings, we have three primary factors influencing our earnings for the remainder of 2017
Operator:
Thank you, sir. [Operator Instructions] Our first question comes from Bob Hopkins with Bank of America.
Bob Hopkins:
Thanks and good morning. Can you hear me okay?
Dan Florin:
Yes, Bob. Good morning.
Bob Hopkins:
Good morning, Dan. So, two questions, one on 2017 and then one looking out a little bit. So first on 2017, just to be clear, so are you saying that the supply issues will be behind you exiting 2017? And then also in 2017, can you quantify the total incremental investment that you are making versus your previous guidance?
Dan Florin:
Sure, Bob. First, with respect to the supply issue, we are saying that by the end of this year, we will have basically cleared back orders, restored safety stock levels to normal levels, which enables our sales force to not only fulfill existing customer demand, but also to start going after new business, which has been a missing piece of our performance. So certainly the expectation is that during Q3, as we have described, we will continue to make progress on all brands. There are these certain brands with more complex remediation and manufacturing processes associated with them, which will lag a bit, but even those certain brands we expect to be in a good shape by the end of 2017. The incremental costs and the changes compared to the prior guidance really has to do with the production costs that we are incurring in the North Campus. There is no change to the remediation cost and the programs associated with that. That remains at approximately $210 million here in 2017. So, the incremental costs to prior guidance that’s included in our adjusted P&L relate to the manufacturing variances out of the North Campus and that’s an incremental $30 million in this new revised guidance.
Bob Hopkins:
Okay, that’s very helpful. And then sort of the obvious follow-up to that is looking out a little bit longer term and how we should think about those incremental expenses, you are revising your 2017 guidance down, that’s obvious in the press release. What I am curious about is do these investments continue into 2018? And when we preliminarily at least think about 2018, can you grow earnings high single-digits in 2018 or are these expenses going to kind of limit growth more to maybe mid single-digits in 2018, again preliminarily?
Dan Florin:
Sure. So first, let me just talk a little bit about the production environment in the North Campus and what’s driving those incremental costs and then what’s the path to recovery, if you will, from a cost profile perspective. I think the way I would describe our approach with the North Campus production is to remediate first and optimize later. And so what I mean by that is we have certainly prioritized our remediation activities on the North Campus, per the commitments we have made to the FDA and we are operating that facility under what we call interim process controls. And I think it’s important to realize that these interim controls include a significant number of manual production and quality control processes and monitoring systems and that’s resulted in significantly higher variable costs of production. So, the end state solution is to implement processes with inherently more process capability and consistency and this will take some time. In addition, the lesson we have learned, we need to create redundant capacity in the network to avoid single points of failure with respect to customer order fulfillment. So as I said in my prepared remarks, the incremental costs will be with us through 2018. And as we think about 2018, we will provide the official guidance, of course, later this year. But I would describe it as this way, Bob. We are certainly prioritizing our investment to restore full product supply to make the progress we need on the production and quality enhancements that I have described and prioritizing investments to drive growth. Now that said, we do have levers available to us, value creation opportunities, whether it be in the COGS area or the SG&A area. But again, we are prioritizing our investments towards growth and production and quality enhancement. So, our goal will continue to be to have a levered P&L next year, growing earnings per share faster than sales, the details of that forthcoming however.
Bob Hopkins:
Great. Thank you. I will get back in queue. Thanks.
Dan Florin:
You are welcome.
Operator:
Our next question comes from Matt Taylor with Barclays.
Matt Taylor:
Hi, good morning. Thanks for taking the question. So, I guess I wanted to understand some of the assumptions in your 2017 guidance. You touched on a few of them in the prepared remarks in response to the first question. But can you talk a little bit more about your customer recapture assumptions and how you think the supply delays are impacting your ability to recapture customers? And maybe within that, what are you doing on the hiring front in terms of the sales force?
Dan Florin:
Sure, Matt. So in developing our guidance, we have considered as best possible about the risks and opportunities. First and foremost, associated with the production, both volume and mix out of the North Campus to clear back orders and replenish safety stocks. The assumptions along the timing and success rate of recapturing lost business and the timing of going back on offense to bring on new surgeon customers have also been updated. They are inherently linked, of course, with production. Healthy product supply will ensure that we are not missing cases. And importantly, free up our sales rep time from being in the mode of case logistics experts to getting back on offense and winning, an important element that’s one of those I would describe as indirect impacts of the supply issues. With respect to recapture, we are seeing instances where some surgeons are waiting to move their business back to us until they see a full product offering with a steady flow of supply for a period of time. So while we’re getting healthy on certain brands of a particular family, if there is other sub-segments of that family that have not yet healthy on supply, we are seeing instances where the surgeon customer maybe waiting to flip the business back over to us. So that’s why getting full supply across the full spectrum of parts is so critical to that recapture assumption. In terms of going back on offense, again, we’ve been prioritizing existing customers and have not been able to bring in new customers to offset some of that natural churn of surgeon activity that takes place in the normal course of business. So bottom line, Matt, we are in the early stages of getting healthy on supply and then experiencing what that recapture rate looks like. What we are doing to ensure that the sales teams are ready to run with that full supply is looking at rolling in some incremental incentives on win back and growth. So that’s all in motion. But really first and foremost starts with getting healthy on supply. And then lastly, with respect to the field force and headcount, we had another quarter of net positive adds in total to the sales channel.
Matt Taylor:
Okay, that’s helpful. And just one follow-up on the pipeline, you have a number of knee products and some other products like in shoulders that you have talked about launching over the next 18 months, let’s say. How are these issues impacting those timelines, if at all?
Dan Florin:
As you said, Matt, we have some critical new products that are in the pipeline, particularly in the knee portfolio that are going to fill critical gaps in the portfolio. And we will be launching the Persona Partial Knee, a full commercial launch, later this quarter. And just to remind folks, the Persona Partial Knee replaces the fixed bearing knee that had to be divested as part of the merger. So, that’s an important segment of the partial knee market that we have not been participating in. The early clinical feedback on that product is excellent and we have high hopes for Persona Partial Knee. So again, that will launch later this quarter. We also called out the Persona TM cementless knee, again, a very important sub-segment of the knee market, a fast growing sub-segment of the knee market. So that will be launching in the second half of 2018. That brings with it impactful mix and new business opportunities. So that remains on track with that time frame as does the Persona revision in the pipeline, second half of 2018. We have been without a revision system to the Persona. That’s a critical new product launch. The robotic application on the total knee application, that program, high priority program, we continue to move that forward in line with our original expectations. So broadly speaking, with respect to how we are prioritizing R&D resources, it is the case that we have had to move some engineering capability over towards the remediation program. What we have been doing is taking another look at the critical R&D list and focusing that list down, narrowing it to the most critical R&D programs and then ensuring that those critical programs are fully staffed, they have got full support of all supporting teams and driving those to keep those programs on track.
Matt Taylor:
Okay, thank you very much.
Dan Florin:
You’re welcome.
Operator:
Our next question comes from Mike Weinstein with JPMorgan.
Mike Weinstein:
Thank you and good morning, Dan. I was hoping you could spend a minute on a couple of items that you kind of briefly mentioned here. So, one was the incentive program you are putting in place for the existing sales reps to a) recapture accounts and b) go on the offensive. Is that program in place? Is that a 2018 program or is that something for the balance of the year?
Dan Florin:
That program is for the balance of the year, Mike. I am not going to get into the details of it, but just broad strokes. I mean our existing comp program incentivizes growth, just to be clear on that. So what we are looking at is incremental incentives to make sure that the sales teams are again ready to run as full supply is restored. So, those are new programs that we will be rolling out that specifically reward growth and win back or recapture of lost business and with the full intention of restoring momentum in the field.
Mike Weinstein:
Okay. And then the second item is you have commented on the call like you have in other calls that the net sales force is up globally. I know that you have been building out your dedicated sales force in new categories, where prior to the acquisition, Zimmer didn’t have one. Can you just talk a little bit about where you are in that process in the various areas, obviously trauma, extremities?
Dan Florin:
Sure, sure. So, the comment in terms of adds to the channel was a U.S. comment, but it holds true globally as well. So, it has been a key focus and remains a key focus for us, Mike, to continue to build out focused sales forces and specialized reps, particularly in categories in the S.E.T. category. So within surgical, throughout the – since the merger closing, we have been adding dedicated salespeople within surgical, that will continue. The surgical team continues to do an excellent job with some new products, an excellent job on commercial execution. Within sports medicine, the same playbook, let’s add specialized sales reps that can focus on sports only. We have added reps along the way, and we will continue to add sports med reps throughout the future. The sports med category and then the trauma category and the extremities category, those three areas in particular have been impacted by the North Campus production disruption. So in general, it is clearly our intent to continue to build out and add more dedicated sales reps. We are pacing that as we sit here today in accordance with that supply recovery, but make no mistake, it’s our clear intent to continue to invest in focused sales reps.
Mike Weinstein:
And on the core recon sales force, what has the turnover looked like?
Dan Florin:
Yes, the attrit rate is normal, Mike, with respect to everything the team has been through, I think is a remarkable testament to their belief in our portfolio and our belief and the belief that we are going to restore full supply. So I would describe that build as kind of normal course. The real incremental investments are in the specialized sales force. But the core recon sales force in the U.S. is stable. They are anxious to get supply, needless to say. And look, a big part of supply, whether it’s the direct impact of supply or indirect impact of supply, the key next step is to, of course, get full supply and start restoring trust, trust within our sales force, trust within our surgeon base that they no longer – there is a day where they will no longer have to worry about product being available. And we know that day is coming. Again, we want to make sure we have the right people, the right quantities of people, the right incentives in place to catch that and run with it.
Mike Weinstein:
Understood. Thanks. That’s helpful, Dan.
Dan Florin:
Thanks, Mike.
Operator:
We will take our next question from David Lewis with Morgan Stanley.
David Lewis:
Hey, good morning. Dan, I want to focus on a couple of issues. The first is visibility. The second is on some of these costs that you walked through. So can we just talk about visibility into the back half of the year? I guess specific question is your third quarter guidance doesn’t imply much improvement when you sort of adjust for the comp. So how does that fit with sort of moderately improving supply dynamics into the third quarter? But as you look into the fourth quarter, you actually do get that acceleration in momentum. So I guess the question is, why don’t you see it in the third quarter? And frankly, what’s your visibility in that more material fourth quarter acceleration? How confident are you in these numbers?
Dan Florin:
Sure, David. As we look at the recovery on supply, one of the real lessons in Q2 and we have brought this – these learnings into Q3 and Q4 is the importance of having the full bag ready to go. And I mentioned before that again, it’s early days but there is some indication that surgeons maybe waiting to give us back our Vanguard business, for example, until we have all variants of Vanguard ready to go. And while we are healthy in many brands, there are other brands that are lagging behind. So the approach we have taken with this guidance to account for kind of the state of the state or the dynamics that we are dealing with is number one, we have broadened the range as you see from what we have done historically. And we have looked at the timing of getting healthier across all those brands. And that’s – so that’s what we have contemplated in the Q3 guide. So even though the comp is easier year-on-year, the business momentum is built on a sequential go forward basis and that’s how we have approached Q3, again, with a wider range, the 0.5% to 2% pegged against what we just did at 0.7%. So, that’s reflective of the pace of production, the mix, the recapture. And all of our dashboard clearly indicates that we expect all brands to be healthy mid-Q4, which again enables not missing existing accounts or cases and going back on offense and acquiring new business. So I think the bottom line is that we firmly believe in the opportunity that’s still there, David and our guidance for the back half reflects some momentum building throughout the second half. And we have widened the range from where we have been before just to account for the dynamics. So, on the upper end of that guide, that’s indicating that we land the production volume and mix, the sales force catches it and runs and executes really well.
David Lewis:
Okay. So in the interest of not being cute, it’s sort of if you build it, they will come, you are building in the third quarter and the customers come back in the fourth. Does that sort of paraphrase it?
Dan Florin:
I mean, we are still looking to win business during Q3, David. So – but to your point, it’s certainly a more modest growth rate relative to what we expect in Q4. So yes, we will be building momentum through Q3 and start really landing those – that new business in Q4.
David Lewis:
Okay. And then just on cost, Dan, I wanted to – I know you talked about these things sort of broadly, but I want to see if we could pencil you again on sort of what these costs are. And obviously, we don’t have all the math here. But if at the midpoint, you are lowering kind of $0.30 and maybe $0.10 of that is the adjusted for selling day revenue reduction, I kind of come up with $0.20 of sort of underlying reinvestment, so that’s about $60 million or so. Is the way to think about that $30 million of sort of gross margin from the plant and then $30 million of sort of SG&A reinvestment? And if I think about those two buckets, Dan, how do those play out in ‘18? Do we still have the $30 million of gross margin expense through the end of ‘18, but we sort of get back some of that $30 million SG&A reinvestment? Thank you.
Dan Florin:
Sure, David. I think the – just listening to your question, I think the math around the revenue takedown is off a bit. Now and it’s really because when you think about the revenue takedown is really skewed towards some of our most profitable products and really concentrated in the United States. So the drop-through to EBIT on that revenue takedown is more significant than what you are modeling there. So, it’s clearly well above our corporate average, in other words. So I think that’s, for modeling purposes, something to take into account. And that’s a takedown for all the reasons that we have described that we expect that to turn around. So, as we think about through 2018, recovering that growth particularly in the United States, the drop-through on that turns back around, right. So that comes back in our favor in 2018 as we restore momentum in the U.S. channel. So, that’s a big element in terms of the EPS takedown. The variances as described, a total in the 2017 P&L, it’s a total of about $60 million that’s in the P&L from a variance perspective, an incremental $30 million, thinking about that next year that – assume that, that’s in the P&L next year. So then back to your question about what other levers do we have, we want to make these investments whether they are incentives or training and education programs, sales support costs, keeping these critical R&D programs moving ahead as well. As we exit this year and think about guidance for next year, we have a line of sight to additional levers to pull on. Of course, I have a point of view on that. When the new CEO comes in, I will review that with the new CEO and we will decide how we want to approach 2018 from a reinvestment perspective.
David Lewis:
Okay, thanks, Dan.
Operator:
Our next question comes from Joanne Wuensch from BMO Capital Markets.
Joanne Wuensch:
Good morning and thank you so much for taking the question. Understanding that all of the changes that have happened regarding your CEO search are relatively fresh, do you have a sense of timing? Do you internally or does the board internally have a view towards, okay, we should probably be doing this before year end or something of that sort?
Dan Florin:
Sure, Joanne. As I said in the prepared remarks and in our release, the board has retained an executive search firm, so that firm is now in place. As described, the board is looking for a proven growth-oriented leader with a strong background both operationally and strategically. So clearly, we are moving forward with a sense of urgency, but there is no defined timetable. The board is willing to take its time to find the right candidate. So that’s really the – that’s the plan and we are off to a strong start.
Joanne Wuensch:
Okay. And then to get into some more of a line item idea, can you discuss what’s happening in your spine business? It’s a little over a year since you purchased LDRH. That appears to be integrated. But what is going on in broadly the spine market and your business within it? Thank you.
Dan Florin:
Sure. So, I think importantly, you are right, we have anniversaried here in July with the acquisition of LDR. The commercial integration, meaning the sales force integration of that channel is largely complete. And similar to the orthopedic sales channel, that’s a critical – it’s a critical asset. It’s a critical part of the integration and getting that right is mission-critical. It’s taken us the full year to do that. I think in the past, we have described how we have oriented the channel to make sure that we have full coverage of our full spine portfolio. So we have got representation across the full surgeon base. The Mobi-C product line continues to perform exceedingly well. We have very high hopes for Mobi-C. It’s clearly a differentiator. The non-Mobi-C part of the portfolio has been challenged with the integration. So, there has been some level of dis-synergies as we have been integrating the channel. So, our expectations – with the channel complete, our expectations is that in the fourth quarter of this year, we have a global spine business on an apples-to-apples basis that’s growing and contributing to overall Zimmer Biomet growth.
Joanne Wuensch:
Thank you very much.
Dan Florin:
You’re welcome.
Operator:
Our next question comes from Richard Newitter with Leerink Partners.
Richard Newitter:
Thanks for taking the questions. Dan, the first one is on the recapture side and then my second one is on the manufacturing. On the recapture, you indicated that – well, I was hoping you could just breakout for us, of those customers that have been supply impacted, what percentage are in this kind of, we want to come back, but we want to wait for a thorough portfolio availability versus those that you have identified that are probably kind of trialed and out of the Zimmer camp?
Dan Florin:
Rich, it’s still really early days to fully know the answer to that question. I will just say that we have clear line of sight to the surgeon level in terms of where we have been gaining business, where we have been losing business, surgeons that have been added to the funnel or lost, so to speak, in the funnel. So, clear line of sight to where that business and opportunity is. So, without getting into the weeds on that, we still have high confidence that surgeons again want to use our product. We have described it as the broader issue is the case where surgeons have moved some of their business to a competitor, because of our inability to fully supply them. So we are referring to that as kind of borrowed market share. So, our ability to recapture that is critical. We are still confident we are going to be able to do that with a full supply. And again, that aspect of being on offense is a critical part of the growth and momentum story as well, just making sure that we are able to attract new surgeons while at the same time serving existing customers.
Richard Newitter:
Okay, thanks. And then in response to an earlier question, I think it was David’s question, what gives you confidence kind of in the ramp or what maybe you miscalculated when you gave guidance on the manufacturing remediation efforts and where you would be by the second quarter into the third quarter last time? It sounded like it was a little bit more you maybe miscalculated this issue of what it would take for customers who wanted to come back online to actually come back online. That seems more on the demand side. But on the manufacturing side, you are also running a little bit behind your schedule. So I guess my question is why should we have confidence that you are kind of – by end of 4Q 2017, these manufacturing issues are behind you, where you kind of had that timeline planned out before? Has anything changed in your planning processes, the team that’s in place that’s overseeing this? What can you say to give us confidence that you have got the right kind of target here?
Dan Florin:
Sure, sure. We have obviously been learning a lot through this, okay. I described before the approach to the North Campus is first and foremost to remediate the plant and then to optimize it. I think just taking a step back a little bit, just to remind people that the Biomet Warsaw facility has historically had an excellent FDA track record, producing products for decades with a strong and lengthy clinical heritage. And the plant has operated in a particular manner for decades, with established manufacturing and quality processes. And look, we are on a journey to remediate those processes and also raise the plant up to more contemporary quality standards. And without a doubt, the journey has been more complex than we anticipated. So I think I want to acknowledge that due to the ongoing remediation work and interim process controls in the North Campus, of course, there’s some risk of future disruption in production. We believe we have a strong grasp on the issues, Rich, and we’re implementing the appropriate solutions. We are running the plant under these interim controls with more manual production and quality control. So kind of the inherent risk is above normal. And I think we’ve learned from that. Our updated timetables, I believe, account for that as we look through the journey in the back half of the year. And there is – we have made changes from a personnel perspective. I believe strongly we have the right team in place with the right focus and the team is doing everything possible to meet these revised dates.
Richard Newitter:
Thank you.
Dan Florin:
You’re welcome.
Operator:
And we will take our next question from Larry Biegelsen with Wells Fargo.
Craig Bijou:
Hi, guys. It’s Craig on for Larry. Thanks for taking the questions. I want to start with top line growth progression. Obviously, Q3, you expect an acceleration, Q4, an acceleration on – the sequential acceleration on top of Q3. So just want to think about 2018 and is that 2% the right way – could it be thought of as a jumping off point for 2018? And then also just wanted to see, is 4% that you have mentioned before, before some of the production issues, is that still the right long-term target growth for the company?
Dan Florin:
Sure, Craig. We absolutely believe 4% is the right long-term top line growth rate for the company. The Q4 range of 1% to 3%, the high-end of that range says that we have executed commercially and manufacturing wise in the right manner. That opportunity exists to exit in that, take the midpoint, 2%, to your point. So, the path to 4% is absolutely clear to how we deliver that. And it first and foremost starts with better performance in the U.S. with respect to hips and knees. And again with full supply, with a sales force ready to run, that’s our goal through 2018. And the importance of the new product flow that’s going to be coming into that channel starting later this quarter with Persona Partial Knee and then the cementless and revision Persona coming later next year is an important part of that. You combine that momentum with the S.E.T. category, a spine business, as I said that we expect to contribute to growth in the fourth quarter and carry that momentum into 2018. So 4% is clearly the goal. We still believe that’s very achievable. One other point with respect to production feeding that and the North Campus is I just want to make the point about the importance of the buffer inventory that we will be building in the back half of this year and how important that is to restoring trust in the channel. With safety stock inventory or buffer inventory, that really does protect the field from disruptions from a production perspective. So that’s why we have been so focused on clearing back orders, building safety stock, getting back on offense. That safety stock buffer is a critical part of the equation.
Craig Bijou:
Thanks. That’s helpful. And as a follow-up, Dan, you have talked about the spine business quite a bit. And with the management change upcoming with respect to the spine business and the dental business, I just wanted to see if there is any change in strategy going forward. I know at times, there has been discussion about potentially divesting the dental business. So, just wanted to get a sense for if there is any change in the spine or dental strategy?
Dan Florin:
Craig, I would tell you that our strategic priorities and objectives are unchanged, accelerated top line growth with full product supply and with strong commercial execution, while at the same time making progress on our production and quality enhancement program and then moving ahead with the critical R&D programs that we have talked about. Management and the board frequently discuss and evaluate many strategic alternatives
Craig Bijou:
Great. Thanks for taking the questions.
Dan Florin:
You’re welcome.
Matt Abernethy:
Lauren, we have time for one more question.
Operator:
Our next question comes from Glenn Novarro with RBC Capital Markets.
Glenn Novarro:
Hi, good morning, guys. Thanks for taking the question. Hey, Dan. Can you just give us a quick update on how the dialogue is going with the FDA regarding the 483s on the North Campus? There are a number of 483s. Where are you in kind of the remediation effort, kind of checking the box off on the observations? And it seems to me though that even with all the observations, you are still going to be getting approval out of these facilities given the timelines you have given, for example, on some of the Persona products. So that’s my first question. And I had a quick follow-up.
Dan Florin:
Sure, Glenn. We continue to communicate with the FDA regarding the status of the corrective actions and remediation work for the North Campus. So, that process is ongoing. The team is making excellent progress, consistent with our responses to the 483s. And we will keep all stakeholders up-to-date with appropriate disclosures in our periodic filings. Sorry, go ahead.
Glenn Novarro:
Well, I was going to say at this point, one of the concerns we often hear from the investors is could this lead to a warning letter? Can you comment on your thoughts there?
Dan Florin:
It’s hard to predict, Glenn, what the ultimate outcome is. We continue to communicate with the FDA on the progress we are making towards that remediation plan that we have detailed out. So we are kind of heads down, executing that remediation plan and moving forward.
Glenn Novarro:
Okay. And then just my last follow-up, you talked about supply constraints in the S.E.T. segment. Are those products coming out of the Warsaw plant or is this a different plant?
Dan Florin:
No, they are coming out of the North Campus, the Biomet Warsaw facility. So specifically, across legacy Biomet sports medicine, legacy Biomet extremities, upper extremities and then certain trauma products are – come out of that North Campus. So yes, that is impacting the S.E.T. growth rate on a temporary basis.
Glenn Novarro:
Okay, great. Thank you.
Dan Florin:
You’re welcome, Glenn.
Dan Florin:
So thanks, everyone. Thanks for joining the call today and we look forward to giving you an update on our progress on our third quarter conference call. Thank you.
Operator:
Thank you again for participating in today’s conference call. You may now disconnect.
Executives:
Robert Marshall - VP of IR and Treasurer David Dvorak - CEO, President and Director Daniel Florin - CFO and SVP
Analysts:
Robert Hopkins - Bank of America Merrill Lynch Michael Weinstein - JP Morgan Chase & Co David Lewis - Morgan Stanley Craig Bijou - Wells Fargo Securities Joanne Wuensch - BMO Capital Markets Glenn Novarro - RBC Capital Markets Steven Lichtman - Oppenheimer Kyle Rose - Canaccord Genuity Matthew O'Brien - Piper Jaffray Companies
Operator:
Good morning. I would like to turn the call over to Bob Marshall, Vice President, Investor Relations and Treasurer. As a reminder, today's call is being recorded. Mr. Marshall, you may begin your call.
Robert Marshall:
Thank you, Mariah. Good morning, and welcome to Zimmer Biomet's First Quarter 2017 Earnings Conference Call. I'm here with our CEO, David Dvorak; and our CFO, Dan Florin. Before we start, I would like to remind you that our discussions during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties. Also, the discussions during this call will include certain non-GAAP financial measures. Reconciliations of these measures to the most directly comparable GAAP financial measures are included within the earnings release, which is available on our website at investor.zimmerbiomet.com. With that, I'll now turn the call over to David.
David Dvorak:
Thanks, Bob. This morning, I'll review our first quarter results, including key highlights from our performance. Dan will then provide additional financial details and our updated guidance. Zimmer Biomet delivered first quarter top line growth and earnings results that were consistent with our expectations coming into the year. In concert with our sales execution, we advanced the ongoing commercialization of differentiated technologies, solutions and services across our industry-leading musculoskeletal portfolio. In March, we showcased several of our most innovative offerings at the Annual Meeting of the American Academy of Orthopaedic Surgeons. These included solutions from our knee business such as our Vanguard Individualized Design total knee replacement and Persona Medial Congruent Bearing as well as a preview of our future robotics total knee platform. From our comprehensive hip portfolio, we featured our G7 Dual Mobility Construct and our unique hip preservation offerings. We also highlighted technologies that address faster-growing categories within the musculoskeletal market such as our Quattro Link knotless anchor for soft tissue repair and our broad range of deformity-correcting foot and ankle solutions. Additionally, our comprehensive Vault Reconstruction System was very well received. This advanced shoulder solution features the first commercially available patient-matched glenoid implant and integrates with Zimmer Biomet's unmatched range of intelligent instrumentation options. Importantly, we capitalized on this global medium by getting our stakeholders an in-depth look at Zimmer Biomet Signature Solutions, our suite of end-to-end clinical services and digital technologies for musculoskeletal practices. We generated positive feedback from clinicians and representatives from institutions who are interested in pursuing Zimmer Biomet Signature Solutions to drive enhanced patient outcomes, clinical efficiencies and cost savings across the entire episode of care. We look forward to further developing and commercializing Zimmer Biomet Signature Solutions in 2017 and beyond. Before turning to our sales performance, I'll provide an update on the product availability of certain legacy Biomet brands as well as our ongoing investments into manufacturing and quality excellence. First, from a manufacturing perspective, as described on our January call, we have continued to implement operational process improvements at our Warsaw North Campus manufacturing facility as part of our ongoing regulatory compliance-enhancement efforts. As we implemented these process adjustments during the quarter, we experienced a greater-than-expected number of temporary and occasional production delays. While our overall production throughput improved during the quarter, these delays resulted in lower-than-expected levels of finished goods and strained inventory availability of key brands throughout the quarter. While these impacts have been more profound and challenging than initially expected, the dedicated efforts of our team members across multiple functional areas supported steady first quarter sales results and, importantly, resulted in an improved and more consistent production output in recent weeks. This progress supports our confidence in our ability to restore adequate supply and accelerate growth during the second half of 2017. As we discuss often, our long-standing commitment to quality is a top priority for our company and the surgeons and patients who rely on our products every day. Consistent with this objective, during the quarter, we continued to more broadly invest in the harmonization and optimization of our global manufacturing and quality systems. Against the backdrop of this ongoing work, we achieved net sales of $1,977,000,000, an increase over the prior year quarter of 4.5%, which included approximately 220 basis points of contribution from the LDR acquisition. Embedded within these global results, our Asia Pacific business delivered a solid 5.9% increase in sales as our Americas region accelerated sales by 4.7% and our Europe, Middle East and Africa region generated 3.1% sales growth over the prior year quarter. Prior to discussing the performance of each of our product categories, I'll provide a brief comment on market conditions. During the first quarter, global musculoskeletal markets continued to demonstrate stable growth, in line with prevailing trends we have observed over the past several years. With regard to pricing, we experienced negative pressure of 2.3% for the first quarter, which was also consistent with our expectations. Turning now to our knee business. We increased sales by 0.6% over the prior year quarter, reflecting positive volume and mix of 3.0% and negative price of 2.4%. Our Asia Pacific business increased sales by 3.1% as our Europe, Middle East and Africa region grew sales by 0.9%, and revenues were flat in the Americas compared to the prior year quarter. We continued to successfully drive the growth of Persona The Personalized Knee System, our flagship total knee, that has now been utilized in more than 500,000 procedures since its commercial introduction in 2012. We also achieved noteworthy sales of our trusted Oxford Partial Knee system, which leverages more than 4 decades of clinical success. Our knee team is really focused on transitioning our new Persona partial knee into full commercial launch during the second half of the year. This latest addition to the Persona product line will complete our partial knee portfolio with a fixed-bearing design that incorporates anatomic compartment-specific solutions and precise efficient instrumentation. Our hip business increased first quarter sales by 2.4%, including positive volume and mix of 5.6% and negative price of 3.2%. Our Asia Pacific region led hip sales growth with a strong 8.9% increase over the prior year quarter as we grew revenues by 2.7% in the Europe, Middle East and Africa region and sales were flat in the Americas. Our Taperloc complete hip system drove steady growth as well as our G7 Acetabular System and our recently launched G7 Dual Mobility Construct. We also increased sales of the Arcos femoral revision system and premium constructs, leveraging our proprietary 3D-printed OsseoTi Porous Metal Technology and vitamin E-infused advanced bearing materials. During the quarter, our Europe, Middle East and Africa hip team hosted over 1,000 orthopedic hip surgeons and leading clinicians at a premier event held by the Zimmer Biomet Institute. This global congress was an invaluable opportunity to present the full breadth of our best-in-class hip portfolio while reaffirming our commitment to offering world-class medical education and surgical training. As we look to the balance of the year, we remain fully confident in the opportunities for growth within our knee and hip businesses while we continue to focus on supporting these trusted brands with greater supply readiness. Turning to our S.E.T. product category. We delivered a solid 6.5% increase in sales, including good performances from each of our geographic segments. During the quarter, we generated strong growth with our differentiated surgical portfolio, highlighted by the sales of our IntelliCart system, which significantly advances fluid and smoke waste management technology in the OR suite. Within our sports medicine business, we continue to drive the growth of our proprietary Gel-One Cross-linked Hyaluronate injection and Subchondroplasty Procedure. From our extremities portfolio, we've enjoyed the benefit from strong demand for our market-leading comprehensive total shoulder system. And the ongoing success of our trauma business was reinforced by noteworthy sales of our A.L.P.S Proximal Humerus Plating System as well as steady demand for our NCB Periprosthetic femur plating system and DVR cross-linked distal radius plating system DVR Crosslock Distal Radius Plating System. We believe our diversified S.E.T. offerings, supported by our specialized commercial organizations, position this important category for ongoing sustainable growth. Our dental sales growth was flat compared to the prior year quarter. This stabilizing performance was supported in part by the sales acceleration of our hybrid surface T3 implant. We remain confident in our ability to optimally position our broad dental portfolio of advanced implant technologies, regenerative solutions and multitiered offerings for this evolving global sector. Turning to our spine, craniomaxillofacial and thoracic category. We increased sales by 32.1%. Building on our progress from recent quarters, we remain focused on executing our spine sales force integration, which will position this business to meaningfully contribute to our consolidated top line growth as 2017 progresses. Our success in these ongoing efforts can be seen in the continued sales acceleration of our Mobi-C Cervical Disc prosthesis, a leading offering for a growing global market. We also capitalized on the demand for our innovative new spine offerings such as the Vitality Spinal Fixation System for degenerative and complex thoracolumbar procedures. Importantly, during the first quarter, our spine portfolio continued to garner clinical validation and industry recognition. The International Society for the Advancement of Spine Surgery recently awarded its Best Clinical Paper for 2017 to a 7-year study on the Mobi-C Cervical Disc prosthesis. This study demonstrated that Mobi-C patients experienced less radiographic adjacent segment pathology compared to those receiving traditional cervical discectomy infusion. Outcomes such as these further validate our ongoing confidence in the future of our spine business. Among our craniomaxillofacial and thoracic offerings, we achieved another strong quarter of growth with the SternaLock Blu and SternaLock 360 primary closure systems as well as the RibFix Blu Thoracic Fixation System. We look forward to the continued positive performance of these differentiated clinical solutions. With that, I'll turn it over to Dan.
Daniel Florin:
Thank you, David. I will review our first quarter performance in more detail and then provide additional information related to our second quarter and full year 2017 sales and earnings guidance. Our total revenue for the first quarter came in at $1,977,000,000, an increase of 4.5% constant currency compared to the first quarter of 2016 and 2.3% constant currency excluding acquired revenue from the LDR transaction. Consistent with our guidance, we recorded slightly less than half of an extra billing day in the quarter as compared to the first quarter of 2016 due to the timing of Easter, which added approximately 70 basis points to the growth rate in the quarter. Net currency impact for the quarter decreased revenues by 0.7% or $12.6 million. The negative currency impact for the quarter was related to the ongoing relative strength of the U.S. dollar versus the euro and the British pound. Our adjusted gross profit margin was 75.2% for the quarter and 50 basis points lower when compared to the prior year due primarily to the impact of price declines and lower gains from our cash flow hedging program particularly associated with the Japanese yen. R&D expense was 4.6% of revenue at $91.1 million, 10 basis points higher than the same period in the prior year. This added expense reflects the inclusion of pipeline activities from acquired companies such as LDR and Medtech, partially offset by a shift of quality and regulatory experts to ongoing remediation efforts at our Warsaw manufacturing facilities. Adjusted selling, general and administrative expenses were $760.8 million in the first quarter or 38.5% of sales, 80 basis points higher than the comparable period in the prior year. The negative variance was driven by increased freight costs due to expedited product shipments and the ongoing absorption of the acquired business expense infrastructure as well as investments in our specialized sales force, offset in part by continued savings in SG&A expense categories stemming from our synergy capture initiatives. In the quarter, we recorded pretax charges of $287 million in special items, which include $169 million of noncash amortization and inventory step-up charges as well as $35 million of quality remediation and $83 million of integration and other items. Our diluted earnings per share were $1.47, an increase of 172% from the prior year. Our current year earnings benefited from a onetime $70 million tax item related to an internal restructuring. Adjusted first quarter 2017 figures in the earnings release exclude the impact of these special items, including the onetime tax benefit. Adjusted operating profit in the quarter amounted to $635.7 million or 32.1% of sales, which was 150 basis points lower when compared to the prior year period. Our adjusted effective tax rate for the quarter was 21.5%, a decrease of 430 basis points from the first quarter of 2016. The reduction is related to the favorable resolution of various international tax matters, which will have ongoing benefit to our effective tax rate. Adjusted net earnings were $433.4 million for the first quarter. Adjusted diluted earnings per share increased 6.0% or 11% excluding the impact of foreign exchange to $2.13 on 203.1 million weighted average fully diluted shares outstanding. A full reconciliation of reported net earnings to adjusted net earnings is included in this morning's press release. Operating cash flow for the quarter amounted to $275.4 million, which included $109 million of cash expenditures for our synergy program and quality remediation initiatives. Capital expenditures for the quarter totaled $129.5 million, including $86.4 million for instruments and $43.1 million for property, plant and equipment. Free cash flow in the first quarter was $145.9 million, which was essentially flat with the first quarter of 2016 and in line with our expectations when adjusting for the timing of certain working capital initiatives. During the quarter, the company repaid $150 million on our term loan. Also during the quarter, the company borrowed $400 million from our senior credit facility to bridge the retirement of a $500 million senior note which matured on April 1. Therefore, gross debt reduction during the first quarter and the first week of April amounted to $250 million. I'd like to now turn to guidance. As a result of lower-than-expected manufacturing output of certain legacy Biomet brands during Q1 that David described and taking into account the resultant diminished product availability entering the second quarter, we are adjusting our view of the second quarter and full year revenue and earnings outlook. We expect to have sufficient inventory as we progress through the second half of the year to enable our commercial teams to drive accelerated growth, albeit with a slight downward adjustment of 25 basis points to our previously guided second half growth rate, which now approximates 3.5% constant-currency growth. For the second quarter, we expect revenues to be in a range of $1,940,000,000 to $1,960,000,000, which reflects a negative impact from foreign exchange of 2.2%. On a constant-currency basis, our growth rate is expected to be in a range of 2.4% to 3.4%, inclusive of a 240 basis point contribution from LDR as well as approximately a negative 100 basis point impact from fewer billing days compared to the prior year. Therefore, the midpoint of our Q2 guidance range is similar to our Q1 performance on a billing day adjusted basis. For the full year 2017, our estimated revenue growth is now expected to be in a range of 2.0% to 3.0%. Foreign exchange is now expected to decrease revenues by 1.2%, which is a 30 basis point improvement from our previous guidance as the dollar has weakened modestly versus many currencies. Taken together, constant-currency revenue growth is expected to be in the range of 3.2% to 4.2%, inclusive of 120 basis points of acquired revenue from the LDR transaction. In dollar terms, revenues are now expected to be in a range of $7,835,000,000 to $7,915,000,000. Our expected range is down slightly from our previous guidance range of $7,855,000,000 to $7,930,000,000, which - with favorable foreign exchange partially offsetting the reduction in our constant-currency growth rate. Turning now to full year 2017 earnings. Although our expected dollar revenue range has decreased slightly, the mix impact of operational growth versus foreign exchange impact has a negative impact on our profitability. Additionally, we are incurring incremental manufacturing and distribution costs to maximize production flow while, at the same time, maintaining critical investments in sales channel specialization, innovative research and development programs and medical training and education. Special items for the year are now estimated at $550 million, an increase of $20 million from previous guidance. This includes a $40 million increase in quality remediation costs, which are now estimated at $210 million. Notwithstanding these items, we are increasing our earnings per share guidance due to the onetime benefit of the previously mentioned tax item recorded in the first quarter. We now estimate our reported earnings per share to be within a range of $4.68 to $4.88. However, excluding the impact of inventory step-up and the special items, we are revising our 2017 adjusted earnings per share guidance to a range of $8.50 to $8.60. This EPS range represents 7% to 8% growth over the prior year or 12% to 13% excluding the negative impact of foreign exchange. Our estimated free cash flow range remains unchanged at $1,250,000,000 to $1,400,000,000. Finally, our Q2 expected EPS is in the range of $0.95 to $1.05. After the elimination of inventory step-up and special items, our adjusted EPS range is in the range of $2.08 to $2.13. Our Q2 guidance contemplates the resolution of certain tax matters, which drives a 100 to 200 basis point improvement in our Q2 ETR from Q1. We still expect our full year adjusted ETR to approximate 22.5%. Finally, please note that our guidance does not include any impact from other potential business development transactions or unforeseen events. With that, I'll turn the call back to David.
David Dvorak:
Thanks, Dan. Our achievements during the first quarter have built on the foundations we've laid for improved supply chain throughput and enhanced manufacturing systems. These efforts, along with the contributions from our expanded global spine business, are positioning Zimmer Biomet to deliver stronger, broad-based sales acceleration in the second half of the year. We remain confident in the promising opportunities within the global musculoskeletal market. As we look to the balance of 2017, we'll remain focused on driving sustainable growth through innovation at every level of our global business, guided by our long-standing framework for value creation. And now I'd like to ask Mariah to begin the Q&A portion of our call.
Operator:
[Operator Instructions]. We'll take our first question from Bob Hopkins with Bank of America.
Robert Hopkins:
Can you hear me okay?
David Dvorak:
We can, Bob.
Robert Hopkins:
Great. So first question is I just want to make sure I have a good understanding of what's driving the change in guidance. So I guess, for Dan, first of all, it looks to me like organic revenue growth guidance is coming down by about 50 basis points. Is that all due to these production delays related to the supply issues?
Daniel Florin:
Yes, it is, Bob.
Robert Hopkins:
Okay. And then same question on the earnings side. The change in earnings - on adjusted earnings, is that all related to the increased costs associated with this?
Daniel Florin:
The adjustment to earnings is a combination of the revenue reduction, so the earnings drop-through impact of the revenue reduction combined with the incremental production costs, particularly in the North Campus.
Robert Hopkins:
Okay. And then, David, I just wanted to kind of ask a bigger-picture question on the production delays. So can you just take a step back for us and give us a sense as to what really is the root cause of these issues on the legacy Biomet side and just on the supply side generally? And I just would love it if you could give us a little better understanding of what also the incremental issue is this particular quarter and how long is this going to take to resolve. So I think it'd be really helpful just to give people some perspective as to kind of how we got here.
David Dvorak:
Sure, Bob. Well, as we explained in the last call, we have been working through the integration process to harmonize and optimize our quality and manufacturing systems as part of the integration. Those efforts as it relates to the Warsaw North Campus were greatly accelerated as a consequence of both internal audit findings as well as the FDA's inspection that concluded in the fourth quarter of last year. So we had a pretty fluid situation in the fourth quarter leading into the beginning of this year. We've made accelerated changes to those operations. And obviously, in addition to implementing operational improvements at the facility as part of these regulatory compliance enhancement efforts, we were focused on ensuring that the production was coming back up to satisfy, in a prioritized way, existing customer demand and then working towards replenishing safety stocks that would allow us to go back on offense. Because some of these key brands that come out of that facility provide us with some of our best competitive opportunities, so they're a very important set of brands and strategically relevant to the acceleration of the top line. And so it really is a matter that is focused on that facility. And as we got into the beginning of the year and production began to accelerate back up, it just took us longer to ramp that production back up. You can understand why we'd be operating with an abundance of caution, most importantly, with the interest of the patients that are served by these products in mind. These are high-quality products. We want to make sure that we're putting them out without any compromise, and so the monitoring processes are very sensitive. The implementation of these processes, as I said, this was done on a very accelerated basis for obvious reasons, and it just took us longer to ramp up that production in the first quarter than we originally anticipated. As we exited the quarter and in most recent weeks, those production levels have been brought up to a point where we're going to be able to begin to more fully satisfy existing customers and, as the second quarter progresses, work towards replenishing those safety stocks. So in the summer months, we expect, in particular, to make a lot of progress on that front and to put ourselves in a position then to not only fully satisfy existing customer demand but then go back on offense.
Robert Hopkins:
From where you sit right now, when do you think this is completely behind you?
David Dvorak:
No, I wouldn't say that it's completely behind us, but I think we have better visibility, Bob, on the matter than we did 3 months ago. As I said, the output has risen to levels that allow us to work down the back orders. As those back orders are brought down, some of the cases with existing customers that were currently missing we will regain. That will take us through the second quarter. But then as we exit the second quarter and work into the second half of the year, we do believe that we'll be putting this behind us.
Operator:
And we'll take our next question from Matthew O'Brien with Piper Jaffray.
Matthew O'Brien:
Just to follow up a little bit on Bob's question. As far as your customer base goes, have you seen - at this point, it's a couple of quarters where you've had some of these manufacturing issues. Do you have any sense for your ability to retain share within your customer base given the shortfall in terms of product availability? And what are some of the programs that you're putting in place in order to retain some of these customers as you work through these issues?
David Dvorak:
Yes. I would tell you that the teams have done an excellent job of moving product around and being very responsive to the customer demand. There are instances where we aren't able to satisfy those demands in particular cases, but you should think about it predominantly as instances where we're missing cases with existing customers. But the larger relationship is maintained, and that is part of the reason we have such a high degree of confidence that, as these production flows begin to replenish stocks out in the field, that we'll be regaining those cases. So that's more the matter that's in front of us. And we think it's very achievable to regain those cases, and we'll begin to do that here in the latter part of the second quarter.
Matthew O'Brien:
Okay. And then a follow-up question. I'm looking at - it looks like in the knee and the hip business that the pricing pressure you saw this quarter is the highest that I can find over the last kind of 5 quarters. Understanding Q1 of last year was a little bit lighter than you've been seeing. So are you - that modest elevation in some of the pricing pressure you're seeing in hips and knees, is that a direct result of this manufacturing issue, you're having to give up a little bit more price? And do you think you'll - this will be a level that you may have to continue to deal with over the next couple of quarters?
David Dvorak:
It really isn't related. The slight uptick in price pressure was more geographically focused out of the Europe, Middle East and Africa businesses and, in particular, 2 or 3 countries where we have large share. And those are market-driven price-down efforts in those markets, and so that was really the dynamic that led to the incremental price pressure sequentially.
Matthew O'Brien:
Okay. Should we expect this level of pricing pressure for the next couple of quarters?
David Dvorak:
Well, I think that this is really consistent with our guidance, and nothing's changed for 2017 on our perspective as to what price is going to look like.
Operator:
And we'll take our next question from Mike Weinstein with JPMorgan.
Michael Weinstein:
My question relates to Lotus and [indiscernible]. So when Lotus relaunches later this year, you're going to have the challenge of bringing a product back to market that's been off the market for 6 months. Can you just give us your thoughts on where you think the balance between the 2 settles out for you as it relates to 2018? What do you think respective positions are of those 2 products in Europe?
David Dvorak:
Mike, it was difficult to make out your question if you are directing that our way. [Technical Difficulty].
Operator:
Hearing no response, we'll continue to David Lewis with Morgan Stanley.
David Lewis:
Can you hear me?
David Dvorak:
We can, David.
David Lewis:
Okay. A couple of quick questions here. Dan, I want to start with you on margins. Can you give us a better picture of the factors sort of weighing on margins here both for the quarter and the year? And I guess I'm trying to better understand the dynamic of synergy progress relative to remediation. And sort of what is your confidence for the balance of the year that we have a good handle on this remediation costs given they sort of accelerated here in the quarter?
Daniel Florin:
Sure, David. First, with respect to the integration synergy program, that remains solidly on track. We have described that as an incremental $85 million of benefit in 2017. So that continues to be on track, and the Q1 instalment, very consistent with our expectation. The incremental production costs and I also mentioned in my prepared remarks some incremental distribution costs as we've expedited shipments around the world, the combination of those 2 is the big change. Keeping in mind we're still delivering very strong ex-FX earnings per share growth on an adjusted basis. So I'd say what's changed, consistent with the commentary on the production throughput, it's just costing us more to produce those products out of the North Campus. That will change over time. As we continue to make progress on these operational process improvements, there's no question that the cost to produce products out of the facility will normalize out over time. But we have dialed that in for the remainder of 2017. We've dialed in the incremental distribution expenses, and then we've gone back through and looked at some other productivity initiatives and looking to tightly manage discretionary spending. And you put all of that together, and that's where we landed on earnings guidance.
David Lewis:
Okay. You remain confident that these remediation issues at this elevated level represents the ceiling on the cost for this year?
Daniel Florin:
Yes, David. And keep in mind - so what I just described is included in our adjusted earnings per share, the incremental production costs. Included in that would be some incremental quality inspection. In addition to that, with respect to the remediation activities of the 483 observations, we've also increased that estimate, and that's included in special items. And our prior estimate was $170 million, and we've increased that by $40 million to reflect the additional work that's taking place there. That's included in the special items in our GAAP P&L.
David Lewis:
Okay. And David, just a follow-up question for you, if I could. The thesis for most investors on Zimmer is they want to see that steady incremental organic acceleration. I think, to be fair, over the last few quarters, there's a bit of a "1 step forward, 2 steps back" effect. So I think - what I think most investors would really like to hear is a couple of things, number one, this really is about manufacturing and it has nothing to do with sales attrition and nothing to do with competition. Maybe you could comment on that. And then, once again, I think what they really want to hear is your confidence that when the company says, "We're going to be making these slow steady progress forward," it's now going to be steps forward and not steps back. And maybe you could help us with your conviction on that as we head over the next 2 or 3 quarters.
David Dvorak:
Yes. First, to confirm, David, it is all about that production facility. We have - we believe that even within the first quarter to second quarter, you can think about that production facility impacting the top line growth at an estimated 150 to 200 basis points. And so quite literally, as those products roll out, everything that we make is going to get sold, and you're going to see the elevated top line off of that. There is no under - any other underlying root cause of the top line performance that we've been discussing. And I would tell you that not only are we confident based upon the progress that we're making on the production side in the recent weeks that we're going to be able to fill that demand to a much greater extent by the end of Q2 and moving into the second half of the year, we were really optimistic about some of the other growth drivers we've been working hard to create, including the integration of the spine sales channel and create success with the Mobi-C products. So our vision for the second half of the year is you're going to see this work through. Our large joint business is going to be positively impacted by our progress in this regard. We'll continue to perform well on the S.E.T. category, and we're going to be adding another cylinder to that growth with an integrated spine channel with the best-in-class cervical disc product, Mobi-C.
Operator:
And we'll take our next question from Mike Weinstein with JPMorgan.
Michael Weinstein:
Sorry about that earlier. I was trying to jump back and forth between 2 calls. So I think David asked the right question there. It does feel to everybody like it's 1 step forward, 2 steps back. So what - how do we get to a point where, from an investor standpoint, we have enough confidence that these issues are really behind you in 3 months and that you really will get the second half reacceleration that you're talking about? What can you do from - for the investor base here to give us some confidence that these issues at Warsaw and the issues before them are going to be a thing of the past?
David Dvorak:
Mike, I would just reiterate that the visibility that we have exiting the quarter and in the most recent weeks as to those production levels, the solutions to that, it's really as simple as once the field inventory gets bled down and they're - even with extraordinary efforts, there is no ability to move product around the covered cases with existing relationships, you're going to start missing some of those cases. And that's what transpired in Q1, and we're going to be working our way out of that issue as we exit Q2. So we have very good line of sight as to the product that's flowing out of that facility now, and we can map out precisely what cases we're missing and the status of those relationships. And when you bring those lines together, you see this problem resolving as we exit Q2 and move into the second half of the year. Thereafter, it's a dynamic of not only fulfilling existing customer demand by virtue of the enhanced production levels that we're seeing currently but then rebuilding safety stocks that allows us to go back on the offense and compete very effectively with this great product portfolio for competitive business.
Daniel Florin:
Mike, this is Dan. I would also add that Q1 - I think the right way to think about this is that the Q1 production throughput delays has pushed our time horizon out by approximately 2 months in clearing back orders and replenishing safety stock and getting back on offense. And importantly as David said, in recent weeks, we've reached production throughput out of that campus to levels that are necessary to fuel that. So we've already demonstrated in the past couple of weeks the level of output necessary to fuel that growth. Now there's a time lag between coming out of the facility, getting through terminal sterilization and then pushed out to the field, having complete sets and then going on offense. Those are the - that time lag. But I think it's really important that we have, in fact, been performing, from an output perspective, to the degree that we need to, to fuel the second half growth.
Michael Weinstein:
And David, where does the FDA fit in on all this? I assume the FDA hasn't yet been back on the Warsaw facility for reinspection.
David Dvorak:
Yes. As we provided the update during the last call, we obviously take these matters, as evidenced by everything we're doing, very, very seriously. And we've developed a comprehensive remediation plan to fully address the issues cited by the FDA, and we're going to continue to communicate with the agency as we execute that plan. We're going to take the necessary steps to address these gaps in that operation. And I would tell you we also would express that we remain confident in the quality and safety efficacy of these products. So it just is an ongoing process, Mike, at this point in time, and we'll keep everyone up to date with any appropriate disclosures as that process unfolds.
Operator:
And we'll take our next question from Larry Biegelsen with Wells Fargo.
Craig Bijou:
It's Craig on for Larry. Can you hear me?
David Dvorak:
We can.
Craig Bijou:
I guess, David, for you, just given some of the commentary about rebuilding the safety stock and going back on the offensive, I wanted to ask about - when looking at '18, is it fair to assume that you guys can accelerate on the 3.5% growth you expect in the second half?
David Dvorak:
We think that, that - you should think about that as a base as we exit 2017 and move into 2018. No doubt, there are opportunities to go beyond that. But obviously, work to do and operating plans to be developed before we get specific about that, Craig.
Craig Bijou:
Okay, that's helpful. And I wanted to ask on - with the display of ROSA at AAOS, I wanted to get your view on the place robotics will have in the overall hip and knee market for the next couple of years. I mean, if you step back from the competitive dynamics, just robotics in general, is it going to be a tool just for surgeons that may be placed in a niche market? Or do you see it as a bigger treatment shift?
David Dvorak:
Yes. I think consistent with our discussions and our innovation strategies over the past decade, I would maybe start by characterizing robotics in a broader way into intelligent instrumentation. And I would tell you that as it relates to intelligent instrumentation, more broadly defined, we believe that it's going to be the predominant way, ultimately, that these procedures are done and, frankly, the standard of care. And that includes everything that we've been doing from a navigation platform through custom jigs, the Signature offering, the legacy Zimmer PSI offering. We've done this across various anatomical sites, knees most extensively. We have the iASSIST technology in that space, eLIBRA for soft tissue balancing, preoperative planning systems. And these technologies are going to converge in ways that satisfy 3 conditions, improve the quality of care, take cost out of the procedure and enhance the throughput of patients. So I think, again, those are the key value drivers. As we develop those technologies in a portfolio fashion that we're focused on, we think that robotics can have an appropriate place within that. I don't think that, that one tool out of the box is going to be the total answer, rather I think it's going to be a portfolio of technologies that address the needs and create value across those 3 dimensions. And so we're really enthusiastic about the broad portfolio that we've assembled. We've been at it for 10 years, and I think it's one of the reasons that as we previewed potential opportunities to bring the ROSA platform into a knee procedure, we think that we can go at that in a differentiated way and leverage all the work that we've done over the last decade, along with our new team members from Medtech, to make a difference in that space. And so I don't know how to break robotics out of a broader portfolio of intelligent instrument solutions that will become the future. But a decade from now, I think that these procedures are going to predominantly utilize these intelligent instrumentation procedures, and I suspect, across various anatomical sites, robotics can be part of that portfolio.
Operator:
And we'll take our next question from Joanne Wuensch with BMO Capital Markets.
Joanne Wuensch:
Can you hear me now?
David Dvorak:
We can, Joanne.
Joanne Wuensch:
At one stage, you had put up a slide that showed sort of an aspirational growth of 4% organic revenue. Do you believe that is still attainable with the current product - the portfolios that you have? And can you give us an idea of what your time frame might look like to reach that?
David Dvorak:
Yes. We absolutely are confident in that capability. We - you reflect back on each of these entities on a stand-alone basis, and for the prior 2 years, before any deal work began, they were performing in the mid-4s on a stand-alone basis. And the portfolio has been greatly enhanced by virtue of the combination. So we're very confident in being able to achieve that goal. And look, our expectation is going to be to exit the year consistent with what we're forecasting, in kind of that midpoint of 3.5% in the second half of the year, and that puts us on a nice path towards the number.
Joanne Wuensch:
Okay. And my second question has to do more with expenses. Obviously, there's a lot in getting everything sort of fully on track. I'm going to assume most of that's running through SG&A. Should we think of your 38.5% in the first quarter as a go-forward rate? Or will you be able to manage that down throughout the year?
Daniel Florin:
Joanne, first, most of the incremental costs that we're incurring beyond our original guidance is actually up on the gross margin line. So the incremental production variances flow through cost of goods sold. The distribution expense that I referred to is in SG&A. But essentially, our gross - or SG&A profile remains on track to migrate back towards the original guidance levels that we have provided. So we'll - that's where a lot of the instalment of the synergy capture is flowing through, and that enables us to move closer towards 37.5% on a full year basis.
Operator:
And we'll take our next question from Glenn Novarro with RBC Capital Markets.
Glenn Novarro:
Can you hear me okay?
David Dvorak:
We can.
Glenn Novarro:
I just had a follow-up on ROSA and then a question on free cash flow. So at AAOS, you talked about ROSA being launched at AAOS in 2019. But in 2018, I think we're all assuming that the Mako launch is in full swing. So what keeps the Zimmer surgeon from migrating to the robot? I know, Dave, you talked a lot about you offer more than the robot. But I'm curious, does the promise of the robot in 2019 keep the Zimmer surgeon from migrating? And are you still confident that ROSA could be launched at AAOS in 2019?
David Dvorak:
Sure, Glenn. That is the track that we're on. We expect to move into clinical evaluation state in the second half of 2018 that would lead to the achievement of that objective of 2019 academy launch in earnest. But in the meantime, we're excited about continued penetration with our intelligent instrumentation offering. We did almost 100,000 cases, as I rattled off just a bit ago, the various technologies within our current portfolio, and that continues to grow. We had a great receptivity on the Signature Solutions front to help better manage the end-to-end episode of care. And again, back to the 3 value drivers of enhanced clinical outcomes, workflow efficiencies and then increased patient throughput, that's what that program is all about, and that's what our intelligent instrumentation offering is all about. So all of that, in addition to the fact, Glenn, that we have some exciting product introductions within that category that are going to make a difference, some of which we've discussed, such as the Persona partial knee that moves into a full release in the second half of this year, and others that we haven't discussed at this point in time but are going to be highly relevant to that same time period that you referenced. And in the aggregate, it puts us in a position to be very comfortable that we're going to compete effectively in our market-leading knee space.
Glenn Novarro:
Okay, great. And just, Dan, on the free cash flow, the guide there is unchanged even though we're taking down adjusted sales and EPS. So can you maybe talk through the puts and takes in the free cash flow for 2017?
Daniel Florin:
Sure. So the free cash flow guide of $1.25 billion to $1.4 billion, as you said, we're retaining that. And really, despite the earnings takedown, as we look at other working capital and operational levers we have available to us at this point in time, we remain confident that we can deliver free cash flow within that range. I think it's important to just remind you that in the current year, there is still significant special items. We've increased the quality remediation spend up to $210 million. In addition to that, there's incremental Biomet integration expenses and other integration activities. So we're still committed to our long-term goal of $2 billion of free cash flow. So within our 2017 guide, there is still hundreds of millions of dollars that should dissipate over time as we work towards that $2 billion long-term goal.
Operator:
And we'll take our next question from Steven Lichtman with Oppenheimer & Co.
Steven Lichtman:
First question is just on the specialized sales forces. How are you looking to grow that overall footprint in 2017? And maybe just an update on how you're seeing the development of the specialized sales forces as a driver of S.E.T.
David Dvorak:
Yes. We haven't disclosed the specific numbers, but it's a key area of focus for us. I mean, between the large joint business versus the other categories, our sales adds are predominantly focused on the non-large-joint categories because we have such a large footprint and an existing capability on a global basis within the large joint section. So it's substantial. We made a lot of progress in the design of the organizational structure at the time of the integration and had a lot of success last year with adds and expect to make another meaningful installment in 2017.
Steven Lichtman:
Okay. And then - and just a second question, Dan, just to further clarify your comments about a couple of months delay in terms of the ramp. So it sounds as though you are seeing the acceleration or ramp of production over the last several weeks. It's just simply a couple of months later than you would have thought, and that's what's sort of pushing it out a little bit. Is that the way to think about your 2-month comment?
Daniel Florin:
That is exactly the right way to think about that, that, importantly, we're currently - in the past couple of weeks, we've seen throughput out of the facility at the levels necessary to clear back orders, to meet existing customer demand, replenish those safety stocks and then get back on offense.
Operator:
And we'll take our next question from Kyle Rose with Canaccord.
Kyle Rose:
Can you hear me all right?
David Dvorak:
We can.
Kyle Rose:
Great. So I just wanted to ask about the pipeline. Obviously, you showcased a lot of products at AAOS. But there's - with the manufacturing and some of the remediation plans going on, I just wanted to understand what, if any, impact the work on that side of the house has impacted some of the timing and cadence of product development launches over the coming 12 to 24 months.
David Dvorak:
Yes. It has caused a reprioritization, but there are - the key products that are in the pipeline now move forward. Many, many products are either in early launch or about to get launched, and I would tell you that notwithstanding the reprioritization, we still have a very robust pipeline. The expectation is still approximately 40 new product launches within fiscal year 2017.
Kyle Rose:
Great. And then just one housekeeping question. I know you disclosed the pro forma growth number excluding the contribution of LDR, but just wondering if you could give us the overall underlying organic growth number for the quarter excluding all acquisitions.
Daniel Florin:
So the - we'll start with, in my prepared remarks, described the constant-currency all-in number of 2.4% to 3.4%, with LDR contributing 2.4%. So ex FX, ex LDR, 0% to 1%. And then we had the billing day headwind of 100 basis points. This is in our Q2 guide. So that 1% to 2% is indicative of the organic growth rate. The other acquisitions are having some impact. We're very pleased with how those products are performing, but I think the right way to think about our organic growth is as we're disclosing it.
David Dvorak:
With that I'd like to - I'm sorry. With that, I'd like to thank everyone for joining the call today and for your continued interest and support for Zimmer Biomet. We look forward to speaking with you on our second quarter conference call. I'll turn it back to you, Mariah.
Operator:
Ladies and gentlemen, that concludes the Zimmer Biomet , Inc. First Quarter 2017 Earnings Conference Call. You may now disconnect. Thank you for using AT&T Teleconference.
Executives:
Bob Marshall - VP, IR and Treasurer David Dvorak - CEO Dan Florin - CFO
Analysts:
David Lewis - Morgan Stanley Mike Weinstein - JP Morgan Bob Hopkins - Bank of America Merrill Lynch Matt Taylor - Barclays Josh Jennings - Cowen & Company Glenn Novarro - RBC Capital Markets Joanne Wuensch - BMO Capital Management Larry Biegelsen - Wells Fargo Bruce Nudell - Suntrust
Operator:
Good morning. I would like to turn the call over to Bob Marshall, Vice President, Investor Relations and Treasurer. Mr. Marshall, you may begin your call.
Bob Marshall:
Thank you, Anna. Good morning and welcome to Zimmer Biomet’s Fourth Quarter 2016 Earnings Conference Call. I’m here with our CEO, David Dvorak; and our CFO, Dan Florin. Before we start, I’d like to remind you that our discussions during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties. Also, the discussions during this call will include certain non-GAAP financial measures. Reconciliations to these measures to the most directly comparable GAAP financial measures are included within the earnings release, which is available on our website at investor.zimmerbiomet.com. With that, I’ll turn the call over to David.
David Dvorak:
Thanks, Bob. This morning, I will review our results for the fourth quarter and full year, as well as key highlights from our performance. Dan will then provide additional financial details and discuss our 2017 guidance. As we reflect on 2016, our accomplishments reinforce our confidence that Zimmer Biomet remains well-positioned to maximize long-term value creation for our stockholders. Throughout the year, we made strategic investments to further broaden and diversify our musculoskeletal portfolio, including the introduction of more than 50 new clinical technology solutions and services. These commercial introductions have both enhanced our core offerings and expanded our presence across the full continuum and episode of care. Investments in our spine business in 2016 have added differentiated technologies such as the Mobi-C cervical disc prosthesis, which positions us to increase our share in the $10 billion global spine market. Among other exciting additions, we also strengthened our presence in sports medicine with the strategic acquisition of Cayenne Medical, which has expanded our offering of soft tissue repair and reconstructive solutions to address the $18 billion S.E.T. market. And importantly, as we noted in mid-December, during the fourth quarter, we continued to make progress towards enhancing and improving our supply chain, and manufacturing and quality systems. We anticipate continued progress towards the replenishment of safety stocks on key cross-sell products throughout the first half of 2017, which will position us for accelerated top-line growth during the second half of the year. Looking ahead, we remain committed to clinically relevant innovation and commercial excellence as key drivers of our growth. We’ll continue billing out our specialized global sales forces in 2017 to capture growth opportunities in attractive market categories. To that end, we look forward to extending the release of Zimmer Biomet Signature Solutions in 2017. This integrated offering is the first suite of end-to-end services, uniquely designed to enhance patient outcomes in musculoskeletal procedures while capturing pre-operative efficiencies and care episode cost savings. And as part of Zimmer Biomet’s Signature Solutions, we will remain focused on the expansion and enhancement of our industry-leading intelligent instrumentation options, which in 2016 were utilized in nearly 100,000 procedures worldwide. Before I review our performance, I’d like to briefly comment on fourth quarter and full year market conditions. During 2016, global musculoskeletal markets exhibited stability with the slight acceleration in the fourth quarter. With regard to pricing, we experienced negative price pressure of 2.0% for the fourth quarter and 1.5% for the full year, consistent with our expectations and prevailing trends over the past several years. I would also like to note that we had approximately one less billing day in the quarter, compared to the fourth quarter of 2015, which reduced our consolidated growth by approximately 140 basis points. The billing day difference is varied by geographic segment with the Americas and Europe, Middle East and Africa regions each having one less billing day. There was essentially no impact in the Asia Pacific region. The impact of this billing day difference is not reflected in the growth rates I’ll be providing by segments and category. During the fourth quarter, we drove improved top-line growth across our portfolio, finishing the year with the revenue performance more in line with our original expectations for 2016. Our solid performance was supported by the reacceleration of our core knee and hip categories, as well as the ongoing strength of our S.E.T. category in Asia Pacific sales region. Consolidated net sales were $2.13 billion for the fourth quarter, an increase over the prior year period of 4.4%, including approximately 230 basis points with contribution from the recently acquired LDR Holding Corporation. Our performance in the U.S. accelerated by 320 basis points on a comparable basis, relative to the third quarter, which supported a 5.3% sales increase in the Americas over the prior year period. In the Asia Pacific region, we also delivered 5.3% quarterly sales growth and our revenues increased by 1.5% in Europe, Middle East, and Africa. Full year sales for 2016 were $7.680 billion, an increase of 3.4% over 2015 constant currency adjusted pro forma results, which included approximately 110 basis points of contribution from LDR. Zimmer Biomet’s knee business grew sales by 1.8% in the fourth quarter, reflecting positive volume and mix of 3.7% and negative price of 1.9%. These results were supported by contributions from each of our sales geographies, led by the Asia Pacific region, which delivered solid 5.2% revenue growth over the prior year period. Our Europe, Middle East and Africa region grew sales by 2.9% over the prior year period, and sales increased by 0.6% in the Americas region. Importantly, focused execution within our knee supply chain and commercial teams during the quarter allowed us to make progress towards meeting a significant market demand for Persona, the Personalized Knee System. In addition, we continued to achieve sales growth across our complete port folio of knee solutions, highlighted by the exceptional performance of our Oxford Partial Knee System and solid results for our Orthopedic Salvage System. Going forward, we will continue diversifying our knee offerings with differentiated new technologies to further complement this market-leading portfolio. Hip sales increased by 2.9% in the fourth quarter, including positive volume and mix of 5.2%, and negative price of 2.3%. Our Asia Pacific region delivered noteworthy hip growth during the quarter, increasing sales by 7.1% over the prior year period. We grew sales by 2.4% in the Europe, Middle East and Africa region and by 1.7% in the Americas. Our improved hip growth was highlighted by the ongoing strength of our G7 Acetabular System, including the successful expanded introduction of the G7 Dual Mobility Construct as well as the Taperloc Complete Hip Stem and the Arcos Femoral Revision System. We were also pleased by market demand for hip constructs to leverage our proprietary OsseoTi Porous Metal Technology and Vitamin E infused advanced bearing materials. As we continue working to accelerate our global hip performance, we remain bullish on our broad and clinically proven portfolio of personalized hip solutions. Our S.E.T. business completed a noteworthy 2016, with solid fourth quarter results, delivering a 6.6% year-over-year sales increase. Our surgical business has continued to benefit from our growing emphasis on sales force specialization. In sports medicine, demand for our proprietary Subchondroplasty procedure and Gel-One Cross-linked Hyaluronate injection remain strong. Our upper extremities portfolio also continued to deliver growth with increased demand for the comprehensive Total Shoulder System and the Nexel Total Elbow. And in trauma, our progress throughout the quarter and full year were supported by the steady sales performance of versatile and trusted solutions such as our NCB Periprosthetic Femur Plating System, AFFIXUS Hip Fracture Nail System and DVR Crosslock Distal Radius Plating System. We believe our global S.E.T business will continue to meaningfully contribute to our long-term growth. Our dental category sales decrease 8.6% compared to the prior year period. We are working to improve our dental performance in 2017. The global dental implant market remains an attractive opportunity with the mid single-digit growth rate profile. We’ll remain focused on innovating and repositioning our dental portfolio including the commercialization of multi-tiered offerings for the evolving global marketplace. Spine, craniomaxillofacial and thoracic sales increased by 29.1% for the fourth quarter, with stable underlying spine performance in total, and continued growth in CMF and thoracic. Within our spine business, the Mobi-C Cervical Disc prosthesis continued to deliver excellent sales growth in the quarter. This highly differentiated product is now the most widely covered device for one and two level cervical disc replacement by commercial health insurers in the United States. We’ve also been pleased with the ongoing acceleration of our innovative Vitality Spinal Fixation System and all-inclusive pedicle screw platform for complex thoracolumbar procedures. As we finalize the integration of the commercial channel in 2017, we believe our spine teams will be well-positioned to capitalize on these and other promising opportunities among our competitive spinal offerings. Turning to craniomaxillofacial and thoracic, this business completed the year on another quarter of solid growth. Our SternaLock Blu and SternaLock 360 primary closure systems continued to drive growth as well as the RibFix Blu Thoracic Fixation System. In 2017, we look forward to introducing differentiated expansions to our craniomaxillofacial and thoracic portfolio. With that, I’ll turn it over to Dan, who will continue this discussion in greater detail as well as review our guidance. Dan?
Dan Florin:
Thank you, David. I will review our fourth quarter performance in more detail and then provide additional information related to our first quarter and full-year 2017 financial guidance. As David discussed, we were pleased with the sequential improvement of our global large joint business, along with continued steady performance by our S.E.T. business, which posted 8% constant currency day rate growth. While product supply constraints remain, our performance in the quarter reflects excellent coordination and execution by our operations and commercial teams to effectively deploy inventory and instrument sets to fulfill strong demand from our existing customer base. We were also able to deliver an incremental $10 million of international tenders and distributor stocking orders that had previously been forecasted for the third quarter. Transitioning now to the balance of our fourth quarter financial performance, our adjusted gross profit margin was 74.6% for the quarter, which was 100 basis points lower when compared to the prior year adjusted results. The decrease was driven by the impact of fewer gains from our cash flow hedging program due to unfavorable year-over-year contract effective rates as well as average selling price declines, offset in part by a reduction in the medical device tax expense recognized in the quarter as compared to the prior year period. Selling general and administrative expenses were $756 million in the fourth quarter at 37.6% of sales, a 20 basis-point increase compared to the prior year period. As anticipated, ongoing investments in our specialized sales forces, and medical training and education programs combined with the inclusion of our recent acquisitions, offset the benefit of SG&A cost synergies in the quarter. I’m pleased to report that we met our commitment of delivering cumulative net EBIT merger synergies of $225 million by the end of 2016. In the quarter, the Company recorded pretax charges of approximately $523 million in special items, primarily related to the Biomet acquisition and integration related expenses. Adjusted fourth quarter 2016 figures in the earnings release exclude the impact of these charges which include $243 million of non-cash amortization inventory step-up and brand rationalization charges; $145 million related to integration activities; a net $53 million of debt extinguishment costs; and $38 million of quality remediation expenses. A full reconciliation of reported net earnings to adjusted net earnings is included in this morning’s press release. Adjusted operating profit in the quarter was $650.7 million or 32.3% of sales, a 140 basis-point decrease when compared to the prior year period due to the lower gross margin rate as well as the expected impact from acquisitions, somewhat offset by Biomet cost synergies. Net interest expense and other for the quarter totaled $94.5 million, consistent with expectations. Adjusted net earnings were $434.1 million for the quarter, an increase of 1.3% compared to the prior year period. Adjusted diluted earnings per share increased 2.4% to $2.14 on 202.5 million average outstanding fully diluted shares. Excluding the unfavorable impact of foreign currency, adjusted diluted earnings per share increased approximately 6% in the quarter. Our adjusted effective tax rate for the quarter was 22% due to a favorable mix of geographic earnings and profits, as well as some discrete items. Our reported effective tax rate for the quarter was negative 103%, due primarily to favorable discrete items. The Company had approximately 200.6 million shares of common stock outstanding as of December 31, 2016, a decrease from 202.7 million shares outstanding as of December 31, 2015. Operating cash flow for the quarter totaled $627 million, an increase of 42% over $441 million in the fourth quarter of 2015. This result includes $105 million of cash expenditures for acquisition integrations and initiatives related to our synergy program. Free cash flow in the fourth quarter was $478 million, which was $167 million higher than the fourth quarter of 2015. Our full year of free cash flow of $1.1 billion was in line with our guidance. Capital expenditures for the quarter totaled $149 million including $94 million for instruments and $55 million for property, plant and equipment. During the quarter, the Company repaid $310 million in total on our term loan and certain of our outstanding U.S. dollar senior notes, bringing the year-to-date repayment total of Biomet acquisition debt to $1.01 billion. Our gross leverage ratio at December 31st was 3.8 times. I would like to turn now to our guidance. I will provide revenue and earnings per share guidance for both the first quarter and the full year. Additionally, I will review our guidance for operating and free cash flow in 2017. Moving now to our market assumptions for 2017, we believe the musculoskeletal markets in which we participate will grow approximately 3%, similar to 2016 when global market conditions remains relatively stable. With regard to price, we forecast a decline of approximately 2%, consistent with the range experienced over the last several years. As David mentioned earlier, we expect to make substantial progress in remediating supply constraints during the first half of this year as we prioritize production for key cross-sell brands, clear our back orders and restore safety stocks. As part of our effort to implement certain regulatory compliance enhancements, we are making operational process improvements in one of our major production facilities. As such, effective products may experience temporary and occasional distribution delays while we implement and validate these enhanced processes and generate the necessary supporting records. Our continued progress towards restoring full supply expected during the second quarter will enable our commercial teams to service existing customers and also resume executing against the full potential of our broad and diverse portfolio. As such, we expect constant currency year-over-year revenue growth to improve as we progress through 2017, particularly in the second half of the year. Now, turning to our guidance for the full year. We estimate revenue growth to be in the range of 2.2% to 3.2%. Foreign exchange is expected to decrease revenues by 1.5%, primarily driven by the strengthening U.S. dollar. Taken together, constant currency revenue growth is expected to be in the range of 3.7% to 4.7%, inclusive of 120 basis points of contribution from the LDR transaction. In dollar terms, revenues are expected to be in the range of $7.855 billion to $7.930 billion. Regarding Biomet net EBIT synergies, we remain confident in realizing our cumulative target of $350 million by mid-2018 with approximately $310 million of cumulative net benefit achieved by year-end 2017. This reflects $85 million of incremental synergies in the 2017 P&L, compared to 2016. As you move down the income statement for 2017, assuming currency rates remain near recent levels, we expect our adjusted gross margin rate to be approximately 75%. This takes into account, the impact of approximately 100 basis points of lower year-over-year effective rates on our foreign currency hedges, in line with our recent disclosures. This headwind is expected to be partially offset by net synergy benefits and cost of goods along with the full annual P&L benefit realization and the suspended medical device excise tax. The incremental benefit to gross margin during the year is estimated at $30 million, which we are reinvesting in R&D, our quality excellence initiative and other programs to drive longer-term growth opportunities. We expect R&D expense for the year to be approximately 4.5% of sales to support our goal to drive differentiated innovation across the continuum and episode of care. SG&A is expected to be approximately 37.5% of sales, compared to 38.2% in 2016, as we continue to realize efficiencies from our synergy initiatives and also further leverage expected revenue growth. Assuming interest rates remain near recent levels, we expect net interest and other expense to be in the range of $335 to $340 million. This incorporates our planned debt repayments throughout 2017 and the benefits associated with our balance sheet activity during 2016. We anticipate an adjusted effective tax rate to be approximately 22.5%, which represents a reduction compared to the 23.5% rate in 2016. This reduction is driven by projected manufacturing and sales geographic mix as well as a realization of several tax integration initiatives expected during the year. We anticipate the full year diluted weighted average shares outstanding to be approximately 204 million shares including the impact of anticipated dilution from employee equity program. The Company is not forecasting or intending to repurchase shares during 2017. Pretax non-cash intangible amortization is expected to be approximately $600 million for the full year 2017. Additional charges include estimated inventory step up of $50 million and special items of approximately $530 million. Therefore including these charges, our full year diluted earnings per share are expected to be in the range of $4.37 to $4.67. Excluding these charges, full year adjusted diluted earnings per share is expected to be in a range of $8.50 to $8.68. This represents adjusted earnings per share growth of between 7% and 9% over 2016. Adjusting for foreign exchange, adjusted earnings per share growth is expected to be in a range between 12% and 14%, which compares to 17% growth in 2016 over 2015 results on a similar basis. Turning to cash flow, we anticipate 2017 operating cash flows to be in a range of $1.75 billion to $1.9 billion. Significant areas of investment included in our operating cash flows are $310 million of outflows in support of our Biomet synergy program and other acquisition integration activities, as well as approximately $170 million of cost to harmonize and optimize our supply chain and manufacturing and quality systems. Total capital expenditures for the year are expected to be approximately $500 million inclusive of instrument capital of $330 million. Free cash flow is therefore expected to be in a range of $1.250 million to $1.400 million. Our guidance assumes that we will continue to delever our balance sheet with planned repayments during 2017, exiting the year with a leverage ratio that keeps us on pace, toward our goal of approximately 2.5 times at the end of 2018. The Company anticipates that substantially all of its free cash flows will be used to facilitate our deleveraging goals alongside maintaining our dividend program. Regarding guidance for the first quarter, we estimate revenue growth to be in a range of 2.4% to 3.4%. Foreign exchange is expected to decrease revenues by 1.3%. Taken together, constant currency revenue growth is expected to be in a range of 3.7% to 4.7% inclusive of 220 basis points of contribution from the LDR transaction. In dollar terms, revenues are expected to be in a range of $1.950 billion to $1.970 billion. The first quarter revenue estimate contains approximately 150 basis points of headwind from our supply constraints. However, as I noted earlier, we expect this headwind to abate as the year progresses. Therefore, estimated constant currency growth rate for the second half of the year is expected to be in a range of 3% to 4.5%. Also in the first quarter, we expect gross margin and operating expense margin ratios to be similar to those embedded in our full year guidance. Our adjusted effective tax rate in the quarter is expected to be approximately 23%. Diluted shares outstanding are estimated to be in a range of 203 million to 203.5 million shares for the quarter. Pretax non-cash intangible amortization is expected to approximately $150 million. Additional charges include estimated inventory step-up of $20 million and special items of approximately $150 million. Therefore, including these charges, diluted earnings per share are expected to be in a range of $0.91 to $1.01. And finally, excluding these charges, we expect adjusted earnings per share to be in a range between $2.08 and $2.13. David, I’ll turn the call back over to you.
David Dvorak:
Thanks, Dan. In 2016, Zimmer Biomet continued to enhance our leadership position through the execution of a consistent strategy that emphasizes growth through innovation, in addition to commercial and operational excellence, and disciplined capital management. Guided by these priorities, Zimmer Biomet is uniquely positioned to drive long-term growth and value for our stockholders, while delivering life changing clinical solutions that meet the unique needs of patients, providers, and healthcare systems. And now, I would like to ask Anna to begin the Q&A portion of our call.
Operator:
Thank you. [Operator Instructions] And we’ll go first to David Lewis from Morgan Stanley.
David Lewis:
David, I want to kind of start with the key question, which is sort of the fourth quarter performance and some of the third quarter disconnect. So, I think in third quarter, you said your hope was to stabilize your share I think in the first quarter and get back to market growth in the second quarter. But, by our math, you basically held share in the fourth quarter, but there were some tenders and maybe some third quarter pull-through. So, could you sort of talk about this notion of sort of getting back to sort of in line with market grow by the second quarter, even though you did a little better in the first quarter and your confidence in getting there over the next couple of quarters? And then I have a couple of follow-ups.
David Dvorak:
Yes, we had executed well in the fourth quarter. And the communications and coordination between those supply chain operations, logistics, leaders, teams and commercial channel, David, was very well done in the quarter. That obviously led to a strong performance sequentially from Q3 to Q4 in some key areas, the large joint reconstructive business improved in a significant way, closed the gap relative to market in the case of knees, probably exceeded the market on a global basis in the case of hips. S.E.T. continued to perform very well. Asia Pacific continued to perform very well also. There is about a $10 million tender that otherwise would have landed in our Q3 numbers, but for the supply challenges ultimately was fulfilled in Q4. So, you can adjust those two quarter numbers as well as relevant jump off point from Q4 into 2017 accordingly. And then also, it appears that the market stepped up, round number is 100 basis points in large joints; and obviously with our share of the large joint market that were daunted [ph] to our benefit in the fourth quarter. So, I would think of our Q1 guidance as being a consistent performance subject to the market and the tender adjustment that I just mentioned in Q4 as we entered 2017. And we continue to make progress on the supply front. So that’s going to position us to replenish the safety stocks in some of these key cross-sell brands in the first half of the year and position ourselves for accelerated growth in the second half of the year.
David Lewis:
Okay, very clear, David, and just maybe two quick follow-ups. The S.E.T.’s franchise for you, that was the real highlight in the back half of 2016. Can you talk about your confidence and S.E.T.’s momentum in 2017 and the perhaps ability for spine to start to show that kind of momentum. And then for Dan just on non-GAAP adjustments, a little heavier in the fourth quarter, can you just talk us about charges in 2017 relative to 2016 and the ability to generate free cash expectations? And I’ll jump back in queue. Thanks so much.
David Dvorak:
Thanks, David. I’ll take the first question. The S.E.T. business performance, as you said, improved sequentially from the beginning of 2016 through the end of the year. And when you adjust for billing days in the case of the fourth quarter, that performance is around 8%. So, we did have a really nice performance in the second half of the year. And we think that that is sustainable as it relates to S.E.T business’s strong product portfolios by virtue of the combination of Zimmer with Biomet, skilled allows us to build out specialized sales forces which we began in 2016 in earnest and will continue in 2017. And then, a strong pipeline of products, all of that augmented by some of the bolt-on acquisition deals that we did such as Cayenne in 2016. So, we like the runway. And it’s important to note that when you add up the markets that those businesses serve, it’s about an $18 billion portion of the $50 billion musculoskeletal market. So, it will be a growth driver into the future for us. And we’re just as optimistic as we complete the commercial channel integration in 2017 of the LDR acquisition that we’re going to be in a position with a much stronger spine portfolio to position that business similarly going forward.
Dan Florin:
And then, David, in terms of special charges for 2017, in my prepared remarks, I talked about just over $500 million of cash special items which should be outside of the amortization and inventory step-up. The biggest components inside of that would be continued spend related to the Biomet integration, our synergy program, as well as the integration of our 2016 acquisition. So, think of that in the neighborhood of about $300 million in 2017. That will substantially step down in 2018. And then, the other component in 2017 is tied to the quality remediation program, which has about $170 million of spend associated with it in 2017.
Operator:
Next, we’ll go to Mike Weinstein with JP Morgan.
Mike Weinstein:
Thank you, and hope you guys have a good morning. I wanted to start if we could, just on the cadence of expectations in 2017. I think you laid it out pretty much as we were expecting. Although I think, I would say, it’s a little bit better. The first quarter, effectively, you’re guiding to 1.5% to 2.5% organic; and then the expectation is that you get to 3% to 4.5% in the second half of the year. So, number one, do I have that right? And then, second, on the second quarter, should we assume that the 150 basis-point headwind that you highlighted in the first quarter from the ongoing supply constraints will be fully resolved? So, how do we think about 2Q? Thanks.
Dan Florin:
Okay, Mike. First, you have the first quarter, correct, so excluding LDR, 1.5% to 2.5% [indiscernible] as well. So, that’s correct. And the 3% to 4.5% growth in the back half of the year does obviously reflect acceleration as a result of the supply improvement. I characterized the second quarter as having some residual supply impact, but not as much that the 150 basis points that we have in the first quarter. So, some improvement as we progress through Q2. We’re not giving the sales range for Q2, but you can expect some acceleration in Q2 relative to Q1
Mike Weinstein:
Understood. And then, the second topic, I think that everybody would like to touch on would be the Warsaw facility in the 483s. David, you made some indirect reference to it. Can you just talk about the efforts there including the expected spend in order to help us off some of these issues in 2017? Thanks.
David Dvorak:
Sure, Mike. Obviously, the manufacture and distribution of the highest quality products is the top priority for our organization. And as part of the integration and our ongoing quality excellence efforts, even apart from the integration, we have been and continue to work to harmonize and optimize our manufacturing and quality systems. So, the observations that came out recent inspection in Q4 in the Warsaw north facility, so legacy Biomet facility, those matters are ones that we take very seriously. We have submitted our written response to the Form 483 observations and developed immediately and are already executing remediation plans to fully address those issues. That work will continue into next year. And I would tell you that the reference that Dan made to some of the expenditures include our efforts to harmonize and optimize those quality systems and fully address those observations. So that installment is part of the $170 million that Dan referenced for 2017. And as I said that work on a broad basis that facility included but not exclusively that facility, will continue on in 2018.
Mike Weinstein:
So that $170 million to optimize the supply chain, how much of that runs through the P&L?
Dan Florin:
So, Mike, what we’re doing is to the extent we are incurring remediation expenses, that’s running through as a special charge to the extent we are making permanent investments in the quality infrastructure and manufacturing overhead infrastructure; that’s running through the adjusted P&L.
Operator:
We’ll go next to Bob Hopkins with Bank of America - Merrill Lynch.
Bob Hopkins:
So, two questions. I wanted to follow up on Mike’s question but before that I wanted to make sure that I ask David a bigger picture question, heading into AAOS this year because obviously there has been a lot of discussion in the marketplace around Stryker’s make a robotic system. And so, I just want to get your updated views on robotics for total knees. Has your opinion on the knee for Zimmer Biomet to have a robotic knee, changed since last year’s AAOS? I just want to get an update from you on that topic, since it’s such a point of interest for investors?
David Dvorak:
Yes. Bob, we continue to make significant investments and be very engaged in the development of intelligent instrumentation. We started that journey over 10 years ago with the acquisition of ORTHOsoft. And as I referenced in my prepared remarks this morning, in 2016, our portfolio of intelligent instrumentation were deployed in nearly 100,000 cases. So that includes signature, patient specific instruments, our ISS technology, our e-liver [ph] technology et cetera. Last year’s acquisition of Medtech with their ROSA robotics platform adds just another tool in technology to our kit. And to the extent that there are anatomical sites that that technology can be applied to in a manner that satisfies three key conditions in our view, improves the quality of the outcome; enhances the efficiencies from a cost standpoint; and drives throughput, patient volume through those providers’ ORs, then those would be applications that we would look to develop and commercialize off of that ROSA platform. So, you can rest assure that to the extent that those conditions are satisfied through our internal development that any other anatomical site would be serviced with that technology. And going forward, as I said, I think that these technologies are going to be big difference makers. I think the reproducibility and enhancing the patient outcomes and patient satisfaction levels are going to be well-served. And what I just described is all underneath the broader end-to-end set of services and suite that we refer to as Zimmer Biomet Signature Solutions. And I would point you to this year’s academy in March because we’re going to have a further unveiling of those offerings as we move into a broader commercial launch of the Signature Solutions platform.
Bob Hopkins:
So, two quick follow-ups, one, just to clarify. So, does that mean that you are developing a robot for total knees? And then, as the other follow-up I wanted to ask was just back on the original question. I just wanted to get your view, David, on just generally how comfortable are you that the 483 won’t lead to further regulatory action? And is that $170 million all kind of -- should we view that as all incremental capitalized spending addressing this issue or are there other things captured with that $170 million? Thank you.
David Dvorak:
So, on the former, obviously, Bob, if we have an internal development project in the specific area, we’ll reveal that when it make sense from a competitive standpoint, and we are prepared to begin the marketing of any application or technology. So that will come with time to the extent that there is a launch in an application in that particular anatomical site. We are comfortable that we have the right remediation plan, the right quality excellence plan that we are engaged in executing. No one can give absolute assurance as to what follow-on activities may come from any agency, but we believe in the plan, we are communicating openly with the agency, and we’ll continue to do so until all those issues are fully addressed. And the spend category, it’s part of a broader quality system and operational harmonization effort, but there is a significant amount of spend on that particular site within that number.
Operator:
We’ll go next to Matt Taylor with Barclays.
Matt Taylor:
So, I guess the first thing that I wanted to just follow up on was looking at the spending that you’re making around the programs with regards to harmonizing and optimizing the supply chain. I guess, could you just reconcile how that compares to disclosures at the end of the third quarter? And you talked about a few things that were necessary to really catch up in terms of supply and harmonize your ability to demand forecast and really prevent the issues that happened in the third quarter from happening again. I guess, I’m just trying to discern sort of A, how that implementation went; and then B, kind of what’s new or what’s the new learning and spending area that’s occurred over the last 90 days since your prior initiatives were started?
Dan Florin:
Sure, Matt. This is Dan. First, with respect to Q3, the Q3 impact had nothing to do with the remediation activity and in the North Campus. So, the Q3 supply issue was in fact a combination of supply chain integration. We talked about the lack of an integrated demand planning and production planning system combined with a significant mix shift of key cross-sell brands, and that disconnect of supply and demand resulted in the Q3 miss. We’ve continued to make excellent progress on implementing better processes and tools to enable a best in class supply chain. We are not complete yet, but we are making really good progress with that. So that was really the Q3 issue. Embedded in our Q4 guidance, we did contemplate some impact from the FDA inspection. And as David has described, we have now submitted our responses; we’ve quantified the cost to remediate that; we’ll update our disclosures accordingly. We had disclosures back in November as well as December with respect to that FDA inspection and we’ll update our disclosures in our periodic filings. So the $170 million as David just said is substantially -- there is a substantial element of that that’s tied to that remediation, and that will continue into 2018.
Matt Taylor:
Okay. I think that’s clear. And then, I guess secondly, when you talk about the revenue progression through the year, you mentioned once you have close to full supply in 2Q, you can start to execute on the portfolio again. I guess, I’m wondering after the shortage and having to service your existing customers, not go after new ones. I mean, how much does that hamper your ability to capture some of that share in future periods? And maybe, you could talk a little bit about once your supply is fully free, how you think you’ll do relative to some of the other competition out there?
David Dvorak:
Sure. I’m highly confident, Matt, in our ability to compete as we restore those safety stocks. And some of those product lines will get to that position sooner rather than later; some of them that pushes out into deeper into Q2. And this is a general matter, we would see in the weeks and months ahead the beginnings of that prospect funnel filling back up and then ripening into competitive conversions as we enter the second half of the year. So, it really is a continuum as opposed to snapping a line at the end of Q2 and only then beginning to redevelop and refill that competitive funnel of opportunities. So, as we look forward, Dan’s references to some of the improvements that have already been implemented, that’s really outside of the North Campus supply challenges we’ve seen pretty significant improvement. Those product lines are already in a position where we can go after competitive business. And as we do the further work on the North Campus and restore that supply, we’re going to be well-positioned for the second half of the year. And the thing I would tell you is just in a reiteration in response to your question is we have supreme confidence in our ability with this combined product portfolio as well as some of the new product launches that have taken place in 2016 and are in the initial stages of launch during 2017 to do very well in the marketplace across all these categories.
Operator:
We’ll go next to Josh Jennings with Cowen & Company.
Josh Jennings:
I was hoping you could just possibly give an update on the ability [ph] of the sales force. And just looking at just making sure that the attrition rates have been normal and that the kind of hiccup in Q3 in the supply constraint didn’t lead to any abnormal attrition rates.
David Dvorak:
We continue to be net adder on the sales force side, Josh, through the end of the year. So, had a lot of success throughout 2016 in building out the specialized sales forces and saw a lot of stability in those sales forces across the globe. So, nothing unusual by the way of natural attrition rates and ongoing hiring that netted to a positive position through the fourth quarter.
Josh Jennings:
Fantastic, thanks for the update. And just follow-up question is just on the organic growth trajectory in the back half. I was just hoping, Dan, you could possibly parse out just the LDR contribution. And clearly there is an acceleration but with LDR turning into organic growth that’s a nice contributor I assume in the second half and heading into 2018. But, if you could just talk about that LDR transition and organic growth and the contribution in the second half, that would be great. Thanks again.
Dan Florin:
Sure, Josh. Certainly, the LDR portfolio has been performing extremely well and Mobi-C in particular driving solid growth. We do expect that growth to continue through -- in the foreseeable future; it’s a very exciting product, it’s a meaningful contributor to our spine portfolio. We’ve been breaking out the impact of the acquired revenues. And we do expect that to move the needle on a combined Zimmer Biomet spine basis for many periods to come. So, in the back half for the year that contribution is in the range of 100 basis points roughly. And I think it’s a real door opener for the rest of the Zimmer Biomet spine portfolio. And we’re very excited about it; we’re very excited about the sustainability of Mobi-C growth, the cross-sell opportunity as we continue to integrate those sales forces, the teams are excited to have that in our bag, the full bag, and we view that as a terrific growth driver in the $10 billion spine market.
Operator:
We’ll go next to Glenn Novarro with RBC Capital Markets.
Glenn Novarro:
Two questions; one, Dave, you talked about the market accelerating in the fourth quarter. Is there anything that you could point specifically that led to the acceleration? Was it just heightened seasonality? Some have thought, maybe there would be a pull forward of cases in December, because patients think they may be losing their insurance with repeal of reform; so, any specific commentary that you can give us? And does this create for example a bigger hockey stick in the fourth quarter of 2017? And then, I have follow-up.
David Dvorak:
Sure, Glenn. It’s yet to be determined, honestly. I think that it is the case that we saw strong demand in Q4 and if anything accelerated demand in the final month of the quarter. Only anecdotal evidence at this point as to what created that demand, I think that the full employment obviously contributes to it. I don’t that -- I think it would be premature to determine that this is sort of an enhancement to the seasonality of the business as much as anything, it could be just the way the holidays fell in December, creating more productive second half of December operating weeks across the globe. And we’ve seen that where the holidays fall in the middle of the week, breaking up each of those two final weeks of the year on the large showing [ph] side for these elective procedures seem to be the case on the spine side as well that led to a really robust demand in the month of December. But I think that it’s smart for us all to let this year play out before we draw a conclusion about whether the seasonality is shifting even in a more profound into Q4, because of high deductibility plans and higher co-pays et cetera along with theories that are out there.
Glenn Novarro:
Okay. And then, the fourth quarter of this year will just be a hockey stick, just because of the easy comps. Correct?
David Dvorak:
Well, the fourth quarter of this year obviously will be up against more challenging comps to the extent that there was anything that was unique to 2016 along with the description that I just provided. I think in our case, we’re going to be well-positioned, because we have replenished stock, and we’re in a better position with secure cross-sell product lines and safety stocks rebuilt to go after the offensive opportunities that we have, Glenn. So, we’re looking to accelerate the topline growth in the second half of the year but not so much based upon prior year comps.
Glenn Novarro:
Okay. And then just lastly, pricing was very stable from 3Q to 4Q in knees and hips. And I know there is always the concern about CJR impacting pricing. So, maybe provide some color as to why pricing is staying so stable and any concerns from CJR as it continues to get rolled out over the next 12 months?
David Dvorak:
We never have expressed significant concerns as to what impact CJR may have on price mix. We’ve said all along, we feel like the dynamics have already been in place that lead to in instances that there is an outlier, high price regression to the mean for that price and greater transparency of pricing across the nation and frankly across the globe. So, I don’t think that the CJR implementation has changed those dynamics. And if anything, our experience in 2016 seems to be consistent with that. And obviously, we’re forecasting similar pricing impact in 2017, Glenn. So, we don’t see any significant impact flowing from CJR in that regard.
Operator:
Next, we’ll go to Joanne Wuensch with BMO Capital Management.
Joanne Wuensch:
Good morning and thank you for taking the questions. Couple of things; can we pull forward a little bit the impact of the FX hedges in the fourth quarter and what exactly you’re guiding for, for the impact in 2017?
Dan Florin:
Sure. The impact in the fourth quarter, Joanne, was 100 basis points on about $20 million year-over-year of a decline in the fourth quarter. Next year, we characterize that as 100 basis points of headwind on total gross margin rate. So, I think you can do the math on the magnitude of that impact year-on-year.
Joanne Wuensch:
And my final two questions; one is, in Washington, there is a lot of interesting things going on, but as it relates to your business, is there anything you want to draw our attention to? And then, the second one also is AAOS coming up, what should we be looking for there? Thank you.
David Dvorak:
Yes, I’ll maybe grab a couple of topics that we’re obviously paying attention to. ACA, repeal and replacement, we’re paying a lot of attention to that. The obvious benefit that is out there is a full repeal of the medical device tax. We’re in the second year of the suspension at this point in time. We get the question often times, Joanne, as to whether or not we would expect some kind of a volume decline to the extent that the ACA was repealed and not fully replaced, and that’s in excess to care question obviously. And all along, our measurements would indicate that volume might have been positively impacted by tens of basis points. And so, we don’t see that as being a significant risk to our volumes going forward. And another question that we get often times is CJR and what happens in that regard with any potential reforms or repeals of the ACA. We think that those end-to-end episode of care reimbursement models, whether it’s in a public or a private setting, our innovation and the go-to market strategy that is probably here to stay in some form, one can speculate as to what the specific form might be as it relates to Medicare in the United States. But, our Signature Solutions offering is geared towards enhancing patient outcomes and driving efficiencies and in the implementation or delivery of that care across the entire episode of care. And I would point you to that particular area of our exhibit space of the academy in reference to your second question, because we have a lot of exciting announcements and a lot of incredible progress and significant customer interest and demand for that set of offering. So, please join at the academy in March, and we’ll walk you through and get little bit more granular with you about what we are intending to do in 2017 by the way of an installment there.
Dan Florin:
And Joanne, maybe just with respect to tax reform, certainly the details are very limited at this point in time, but based on our review of what’s being proposed, the Company’s ongoing U.S. operations, we believe we experience a net tax benefit by virtue of the reduction in U.S. corporate income tax rates. And then even factoring in the border adjustment, when we look at our U.S. revenues, the sources of that production, we’re a slight net exporter, meaning we produce more in the U.S. sold in the U.S. relative to what’s imported for sale in the U.S.
Operator:
We’ll go next to Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
Just two quick ones here. David, could you help or David -- sorry, could you help bridge the Q4 growth to the Q1 guidance? So, adjusting for the tender, you did about 3% in Q4, the guidance is 1.5% to 2.5%; just why the deceleration in Q1? And just to be crystal clear, you talked about occasionally some distributor delays that would end in the second quarter, just trying to understand is that due to the 483 at the Warsaw facility? And just lastly, David, how do you want us to think about dental returning to growth, how long -- how will that progress through 2017? Thanks for taking the questions, guys.
Dan Florin:
Sure, Larry. On the first of those, the reconciliation to the midpoint of the Q1 guidance of 2% is just as you described, you can think about it in the big picture manner as a half point of that reconciliation relating to the tender and a point -- 100 basis points relating to the market step-up from Q3 to Q4 and a reasonable market expectation growth rate for Q1. So, 100 basis points, plus the 50 basis points is the right way to think about the 3.5 to the midpoint of 2.0% for Q1 Larry. Next question was…
Larry Biegelsen:
The 483, I’m just trying to separate out the Q3 issues that you had and the 483 at the Warsaw facility. You talked about it in your prepared remarks as occasionally having some distributor delays, but you’d have full supply in the second quarter. Those distributor delays related to the 483 at the Warsaw facility and you expect that to be completely. You don’t expect any impact from the 483 on your supply after the second quarter or you’ll be back to full supply in the second quarter? I’m just trying to parse out the 483 from the issues in the third quarter because it sounds like they’re different issues. And then, the last one David, sorry for the long question, but just dental, just the progression there. Thanks.
David Dvorak:
Sure. So, as it relates to the North Campus and Warsaw operations there, our mix of matters that are contributing to the supply challenges coming out of the North Campus including remediation to fully address the observation that are articulated in the Form 483. So, your reference to the product flow, it is manufacturing, logistics, the distribution of those products that come out. And in an abundance of caution, the application of these interim controls, as we’re revalidating certain processes is what leads to some of that choppiness. Now, product is flowing out of the facility. We’re going to continue to be in a hyper care state in an abundance of caution until those revalidations are completely executed. That will take some time. But as the months progress in the first half of the year, we expect the distribution of those products to even out and those safety stocks to be rebuilt. And that positions us to grow those important product lines in the second half of the year. As it relates to dental, we continue to be attracted to that market, as I referenced. We see that market as being one that has the opportunity to grow mid single digits. It’s a bit higher growth in some of the so called value sub-segments of the market. We historically have not had any significant presence in that market; we need to develop one. And we’re repositioning the broad product portfolio that we have by virtue of the combination to do a better job of getting after that that market opportunity. And we expect to make progress in 2017, but look for that’s a show up an improved topline second half of the year and as we exit 2017.
Operator:
We’ll take our last question from Bruce Nudell with Suntrust.
Bruce Nudell:
I’m just looking at your revenue guidance. It’s actually kind of tight, so from the midpoint to top and bottom is about 0.5%. And could you just put that in context of your expectations for the hip and knee market, which is about 60% of revenues and your share position in it as well as the continued strength in S.E.T.?
David Dvorak:
Bruce, maybe just to clarify…
Bruce Nudell:
Yes. It just seems like you have a pretty tight revenue range. And it looks like, so it must presume pretty -- that almost 3% hip and knee market and maybe a little bit under market growth and continued strength in S.E.T. Are those reasonable assumptions?
David Dvorak:
Yes, they’re reasonable assumptions for the first half of the year with an acceleration contemplated in the second half of the year; and so, as Dan referenced an assumption that the overall musculoskeletal market roundabout 3% in 2017. And we’re obviously guiding below that in the first half of the year and above that -- at or above that in the second half of the year with our 3% to 4.5% guide for the second half of the year. And so that’s the progression that we see. And I do think that with the portfolio that we have that we would expect as get into the second half of the year to accelerate even in large joints to above market growth rates and then have that further augmented by continued good performance coming out of S.E.T. in the beginnings of realization of the opportunity that we have and have described in the spine market as well, Bruce.
Bruce Nudell:
Perfect. And just back to Bob’s question about Mako, I mean amongst the major players worldwide, you have 40% knee share. And so, clearly, very important franchise to you guys. And my presumption is Stryker’s going to do local studies where they show relative to Stryker implants done freehand with Mako, improved motion after the case, less blood loss, less pain, better stability, better discharge rates. What are you guys doing with your intelligent instrumentation and perhaps even your robotic programs to be ready to counter that kind of individual site type of data that’s likely to emerge from the Stryker effort?
David Dvorak:
Good question, Bruce. And I would just point you back to the Personalized Solutions and Signature Solutions efforts. And we will walk through in a very comprehensive way, the interconnectivity of early patient engagement, optimize pre-operative practices that include the use of our intelligent instrumentation devices in a manner that is consistent with the surgical philosophies that different surgeons may subscribe to and then all the way through tell a rehab service to optimize the patient outcome and drive down the cost of the delivery of care. And we’re really excited about this portfolio. We think that this is the set of strategies that we’ve assembled that is going to be responsive to both patient demands, provider demands and healthcare systems around the globe, and believe it’s a very comprehensive response.
Bruce Nudell:
Perfect. And just to sneak one, selling days in 2017?
David Dvorak:
Yes. I think overall, they washed out consistent with 2016.
Bruce Nudell:
Thanks so much.
David Dvorak:
Thank you, Bruce. So with that, I’d like to thank everyone for joining the call today and for your continued interest and support for Zimmer Biomet. We look forward to speaking with you on our first quarter conference call. I’ll turn it back over to you, Anna.
Operator:
Thank you again for participating in today’s conference call. You may now disconnect.
Executives:
Robert Marshall - VP, IR and Treasurer David Dvorak - CEO Dan Florin - CFO
Analysts:
Bob Hopkins - Bank of America Merrill Lynch Matthew O'Brien - Piper Jaffray Mike Weinstein - JPMorgan David Lewis - Morgan Stanley Larry Biegelsen - Wells Fargo Matt Miksic - UBS Joanne Wuensch - BMO Capital Markets Matt Taylor - Barclays Richard Newitter - Leerink Partners Glenn Novarro - RBC Capital Markets
Operator:
Good morning ladies and gentlemen. I would like to turn the call over to Bob Marshall, Vice President, Investor Relations and Treasurer. As a reminder, today’s call is being recorded. Mr. Marshall, you may begin your call.
Robert Marshall:
Good morning and welcome to Zimmer Biomet's third quarter 2016 earnings conference call. I'm here with our CEO, David Dvorak and our CFO, Dan Florin. Before we start, I'd like to remind you that our discussions during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties. Also the discussions during this call will include certain non-GAAP financial measures. Reconciliations to these measures to the most directly comparable GAAP financial measures are included within the earnings release, which is available at our website at investor.zimmerbiomet.com. With that, I'll now turn the call over to David.
David Dvorak:
Thanks Bob. This morning, I will review our third quarter financial results, as well as provide an overview of some of our new technologies and solutions, and the focused actions we are taking to drive sustainable growth. Dan will then provide additional financial details and discuss our updated guidance. Zimmer Biomet’s third quarter revenue performance was highlighted by the acceleration of our S.E.T. category, and ongoing strength in our Asia Pacific region. However, consolidated sales were below our expectations on weaker than anticipated results from our large joint and dental categories. Overall, broad demand for our differentiated portfolio remained high throughout the quarter, particularly for our focus cross-sell products. Variable commercial performances by our sales teams were in part caused by unanticipated supply constraints related to our transitioning supply-chain infrastructure. This resulted in shortfalls that needed implants and additional instrument sets to fully exploit sales opportunities in key product categories. In response to this challenge, we have accelerated work to enhance certain aspects of our supply-chain infrastructure as we harmonize and optimize our sourcing, manufacturing and quality management systems. Through these efforts we expect to improve our demand fulfillment in the coming months. As a consequence of these supply constraints, we project fourth-quarter sales results to be similar to those of the third quarter. However as we look ahead, we remain confident in our ability to successfully reaccelerate our revenue growth in 2017. As I mentioned, demand for our expansive portfolio of differentiated and clinically proven musculoskeletal technology, solutions and services has never been stronger. Our global sales organizations remain stable and have in fact achieved a third consecutive quarter of net personnel additions. These teams remain focused on delivering high-quality personalized solutions to our customers and their patients. To that end, during the quarter we consummated a number of strategic external development transactions to expand our musculoskeletal portfolio and capabilities while continuing to deliver leveraged earnings-per-share. By joining together with LDR Spine in mid-July we now possess a leading position in the attractive global market for cervical disk replacement. Additionally, our recently completed acquisition of Medtech SA provides us with current brain and spine robotic technology, and positions us to identify and develop additional applications for the ROSA robotics minimally invasive platform. This differentiated technology supports our strategy to offer the industry’s most comprehensive range of intelligent instrumentation options. Also during the quarter we acquired new clinical solutions that extend our reach across the continuum of care, spanning from state of the art 3-D range of motion simulation software to an innovative telerehabilitation platform. These portfolio additions are designed to support healthcare providers in personalizing musculoskeletal treatment. Importantly, these assets further strengthen our Zimmer Biomet’s Signature Solutions offering, which is designed to assist hospitals and medical practices to seamlessly transition to value-based healthcare models. With our end to end clinical services, proprietary technologies and analytical tools we are enabling healthcare providers to maximize productivity and patient engagement across the entire episode of care. As have previously communicated, the rollout of Zimmer Biomet’s Signature Solutions comes in an opportune time when an increasing number of healthcare providers are striving to comply with bundled payment models by placing a greater emphasis on the quality and cost effectiveness of knee and hip replacement service lines. Before I review the performance of each of our sales categories, I would like to comment on third quarter market conditions. We noted overall global market stability during the quarter. In addition, we believe that while the US market demonstrated some softness during the summer months, it strengthened towards the end of the quarter. With regard to pricing, we experienced negative 1.9% of pressure, which was in line with expectations and consistent with trends in recent years. Against this backdrop, Zimmer Biomet delivered third quarter consolidated net sales of $1.83 billion. This performance represented 3.5% of constant currency growth over the prior year quarter of which the recently acquired LDR Holding Corporation contributed 190 basis points. Embedded within these results, we achieved solid 6.4% top line growth in the Asia-Pacific region, while growing sales in the Americas by 3.7% and by 0.9% in the Europe, Middle East and Africa region. Zimmer Biomet’s knee business was flat on a global basis in the third quarter reflecting positive volume and mix of 1.9% and negative price of 2%. Our 2.6% sales growth in the Asia-Pacific region was offset by our results in the Americas, where sales decreased by 0.9%. Our knee revenues increased by 0.3% in the Europe, Middle East and Africa region as compared to the prior year quarter. Despite continuing attractive growth rates during the quarter for Persona, the Personalized Knee System, our sales execution on this leading cross selling opportunity was limited by the supply issues I just mentioned. The Oxford Partial Knee also delivered solid sales results during the quarter. Additionally, we were pleased to announce the commercial launch of our Vanguard Individualized Design total knee replacement system. This first of its kind total knee construct supports our soft tissue preservation focus and market leadership with independent medial and lateral polyethylene bearing that simplify soft tissue preservation and balance. We are committed to driving focused execution in support of stronger knee results in future quarters with this exceptional portfolio. Third-quarter hip sales grew by 0.6% reflecting positive volume and mix of 3.0% and negative price of 2.4%. We grew revenues by a solid 5.9% in the Asia-Pacific region, while sales were flat in the Americas. Hip sales decreased by 1.4% in the Europe, Middle East and Africa region compared to the prior year quarter. Within this overall performance we continue to drive the sales growth of our Taperloc Complete System and Arcos Modular Femoral Revision System, as well as offerings that leverage Zimmer Biomet’s proprietary Vitamin E-infused advanced bearing materials. We were also pleased with the commercial traction of the recently introduced G7 Dual Mobility Construct. We are well positioned to build on these successes in future periods by leveraging the industry’s most comprehensive range of hip solutions. Turning to our S.E.T. category, we achieved a healthy 7.8% increase in global revenues, supported by solid results in all geographic segments. In our surgical business, we have been pleased with the ongoing progress of our growing specialized sales channel and the commercial success of our diversified offerings for the OR suite. Our Sports Medicine results were once again driven by our proprietary Subchondroplasty procedure and Gel-One Cross-linked Hyaluronate Injection. Similarly, our extremities business continued to leverage our market-leading upper extremities portfolio, including the Comprehensive Total Shoulder System and the Nexel Total Elbow. Lastly, we delivered ongoing improvement in trauma with third quarter sales being led by our AFFIXUS Hip Fracture Nail System and NCB Plating system. We expect that our S.E.T. product category will remain an integral component of our sustainable revenue growth platform with innovative clinical solutions that meet the needs of surgeons, patients and healthcare institutions. Dental sales decreased by 7.6%, which was below our expectations. Nonetheless, we achieved good performances from the 3i T3 Implant system and the recently introduced aesthetic implant system. Looking forward we expect to more fully capitalize on this and additional future product launches as we enhance our multitiered offerings to address an evolving dental marketplace. Our spine, craniomaxillofacial and thoracic category sales increased by 23.9% on a constant currency basis in the third quarter, which represented approximately 1% organic growth. Following our recent LDR acquisition, we are making good progress we the initial phases of integration throughout our spine commercial organization. Among our spine offerings, we have been encouraged by the sustained revenue performance of the Mobi-C Cervical Disc prosthesis. Last week we announced that Mobi-C is now the most widely covered device for one and two level cervical disc replacement by commercial health insurers in the United States. In addition, we also continued to deliver growth with the Vitality Spinal Fixation System. We are well positioned to continue to bolster the competitiveness of our spine business with an expanded portfolio and strengthening sales channel. With regard to our craniomaxillofacial and thoracic business we continue to be pleased with the ongoing strong sales growth of the SternaLock Blu and SternaLock 360 primary closure systems, as well as the OmniMax MMF System. With that, I will turn it over to Dan, who will continue this discussion in greater detail as well as review our updated revenue and earnings guidance. Dan?
Dan Florin:
Thank you, David. I will review our third quarter performance in more detail and then provide additional information related to fourth quarter and full-year 2016 sales and earnings guidance. Our total revenues for the third quarter were $1.833 billion, an increase of 3.5% adjusted constant currency when compared to the third quarter of 2015, and 1.6% excluding the contribution from the LDR acquisition. The net currency impact for the quarter was a positive 60 basis points or $11 million on consolidated revenue results. We had an immaterial difference in billings days in the quarter as compared to the third quarter of 2015. Third-quarter revenue was below our expectations primarily due to execution issues within our large joint supply-chain, which led to degradation in order fulfillment rates late in the quarter as well as our performance in dental. As noted by David, customer demand was strong in the quarter but certain aspects of our supply-chain integration impacted our ability to effectively respond to shifting product mix, most notably within our knee and hip portfolios. As a consequence, we underestimated demand for certain key cross-sell brands within our existing customer base leading to a depletion of our safety stocks and also affecting our ability to capitalize on new customer opportunities. We are working diligently to enhance our supply-chain processes and execution, particularly in the areas of demand forecasting, global inventory tracking and asset deployment systems while we replenish our safety stock levels. However, these issues have some carryover effect into the fourth quarter, which I’ll address shortly in the context of our updated Q4 guidance. Turning now to the balance of our third quarter results, our adjusted gross profit margin was 75.1% for the quarter and 110 basis points lower when compared to the prior-year, due mainly to the impact of ASP declines, as well as lower foreign currency hedge gains, which we have been recently highlighting. The company's R&D expense was 5.2% of revenue at $95.6 million, reflecting investments from our recently acquired businesses, as well as our Zimmer Biomet Signature Solutions program. Adjusted selling, general and administrative expenses were $727.7 million in the third quarter or 39.7% of sales which was 40 basis points higher than the comparable period in the prior year. As anticipated, ongoing investments in our specialized sales forces and medical training and education programs combined with the inclusion of our recent acquisitions offset the benefit of SG&A cost synergies in the quarter. We remain on track to deliver cumulative net EBIT merger synergies of $225 million by the end of 2016. In addition to the Biomet synergies, we are also laying the foundational elements for synergy capture in 2017 from our recent acquisitions. In the quarter, the company recorded pre-tax charges of $355 million in special items, primarily related to the Biomet and LDR acquisitions, including $181 million of non-cash amortization and inventory step-up charges as well as approximately $140 million of acquisition and integration-related expenses. Adjusted third quarter 2016 figures in the earnings release exclude the impact of these charges. A full reconciliation of reported net earnings to adjusted net earnings is included in this morning's press release. Adjusted operating profit in the quarter amounted to approximately $553 million or 30.2% of sales, which was a decrease of 200 basis points when compared to the prior-year period due to the reduction in gross margin, as well as expected impacts from acquisitions. Net interest expense and other non-operating expense totaled $94.6 million. Adjusted net earnings were $362.4 million for the third quarter, an increase of 7.1% compared to the prior-year period. Adjusted diluted earnings per share increased 9.1% to $1.79 on 202.9 million weighted average fully diluted shares outstanding. Our adjusted effective tax rate for the quarter was 21.1% which reflects a year-to-date true up to recognize the tax benefit associated with the noted product mix shifts coming from tax efficient supply-chain jurisdictions as well as certain other items. Our year-to-date adjusted effective tax rate is 24%. Operating cash flow for the quarter amounted to $353 million, which included $161 million of cash expenditures for acquisition costs, integration activities, and initiatives related to our synergy program. Capital expenditures for the quarter totaled $150 million, which included $94 million for instruments and $56 million for property, plant and equipment. Our free cash flow in the third quarter was approximately $202 million compared to $16 million in the third quarter of 2015. Ongoing working capital initiatives and improvements are expected to keep the company on track with full year cash flow generation of approximately $1.1 billion. During the quarter, the company repaid $200 million on our term loan, reflecting $700 million of debt repayment since the beginning of this year. Additionally during the quarter, the company consummated its new five-year $1.5 billion multi-currency senior credit facility along with a new $750 million term loan to finance the LDR transaction. As a result, gross debt increased by $550 million in the quarter. I would like now to review our guidance. As we look to the fourth quarter, revenue growth is expected to be in the range of 1.6% to 2.6%. Foreign exchange is estimated to decrease revenue by approximately 30 basis points. Therefore reported revenue is expected to be in the range of $1.960 billion to $1.980 billion. Fourth quarter constant currency growth on a day adjusted basis is expected to be in a range of 3.3% to 4.3%, or 1.0% to 2.0% excluding the contribution from LDR. On a similar basis, the company had previously estimated revenue growth for the quarter in a range of 5.8% to 6.8%, or 3.5% to 4.5% excluding LDR. As a reminder, we have one less billing day as compared to the prior year. Our fourth quarter adjusted earnings per share on a fully diluted basis is now expected to be in a range of $2.08 to $2.13. Turning to the full year 2016, we now estimate revenue to be in a range of $7.630 billion and $7.650 billion, or an increase of approximately 27% on a reported basis or 2.4% to 2.7% on an adjusted pro forma basis in each case as compared to the prior year. The adjusted pro forma revenue guidance range is inclusive of approximately 110 basis points of contribution related to the LDR transaction. We now expect foreign currency translation to decrease full year revenue in 2016 by approximately 30 basis points compared to our previous estimate of 50 basis points with the Japanese yen strengthening against the US dollar and a stabilized euro partially offset by the weakening British pound. Therefore full year revenue growth excluding the impact of the LDR acquisition on a constant currency adjusted pro forma basis is now expected to be in a range of 1.65% to 1.9%. Previously the company estimated full year revenue growth to be in a range of 2.5% to 3.0% on a similar basis. Turning to the full year P&L, after updating our assumptions to reflect our recent performance, acquisitions, a lower expected tax rate, as well as foreign currency exchange rates and the associated operating margin implications, our full-year adjusted diluted earnings per share is now expected to be in a range of $7.90 to $7.95, an increase of approximately 15% over the prior year. Our full year reported earnings per share are expected to be in a range of $1.50 to $1.60 after giving effect to our year-to-date results and anticipated special items in the fourth quarter. Special items are largely associated with non-cash amortization, costs incurred to capture net synergy targets and acquisition-integration expenses. Finally please note that our guidance does not include any impact from other potential business development transactions or unforeseen events. With that, I will turn the call back over to David.
David Dvorak:
Thanks, Dan. Although we were naturally disappointed with these third quarter results, I want to reiterate our confidence in Zimmer Biomet’s market-leading and diversified portfolio as a driver of sustainable long-term growth. We are fully focused on restoring product supply and positioning our commercial teams to deliver on high market demand as we enter 2017. More broadly, we remain committed to creating meaningful partnerships to drive efficiencies across musculoskeletal healthcare with innovative technologies, services and solutions that improve the lives of patients. And now I would like to ask Kareen to begin the Q&A portion of our call.
Operator:
[Operator Instructions] We will take our first question from Bob Hopkins with Bank of America.
Bob Hopkins:
Hi, good morning. Can you hear me okay?
David Dvorak:
We can Bob. Good morning.
Bob Hopkins:
Good morning. So, thanks for taking the question. First a question for Dan and then a question David for you, so Dan, first just on the quantification side, can you give us a sense as to the impact of this sourcing supply issue on Q3 revenue growth and the anticipated impact on Q4 revenue growth and just maybe a sense of how long this will last into 2017, and does this impact earnings outlook for 2017 growth?
Dan Florin:
Sure Bob. First with respect to the quantification of the impact as David said in his prepared remarks as well as mine very important to note that customer demand remains very strong. So that is a real positive and our current supply chain not being fully integrated did hamper our ability to respond effectively to this shifting product mix, and while not anticipated we understand the root causes, we understand the fixes that are necessary and we are highly confident in our ability to implement those changes. It will take several months to make those corrections. In terms of sizing impact for the quarter it is not a perfect science but I would roughly anticipate or estimate that to be about 100 basis points of impact due to the supply issues in the third quarter. We have a very robust backlog of demand and with respect to the impact in the fourth quarter I would size that even slightly above that 1% impact.
Bob Hopkins:
Okay. And then just as a follow-up to start, does this compromise your ability to grow earnings 10% in 2017, and then David for you maybe just a little bit more color on when did this sourcing issue start to manifest and maybe just describe a little bit more exactly what this is, is it only in knees, why only in the US, just a little bit more detail would be really helpful. Thank you.
Dan Florin:
I think Bob, the manifestation was really as the quarter progressed and late in the quarter the science became clear that we had a pretty significant product mix with the lack of visibility on a forward basis that allowed our supply chain to respond obviously if we fully integrate on the operations front. We're going to have a much more agile supply chain and be able to respond to these kinds of demands in a much shorter time period as we are in international state now, we just did not have the ability or the force side. So, part of this is forecasting systems part of it is just operational execution and lead times for these products but primarily driven by the large joint demand, if you think about the cross-sell product categories, you're going to be aligned with the biggest opportunities that we had. And probably on the forecasting side the most significant underestimation was the demand for those same products with existing customers. And so, it cost us to have the step back to make sure that we're redoubling our efforts to serve this existing customers and as we've referenced that took away from some of the authentive opportunities that we have. But please don’t construe that to be a lack of demand. We know that we have significant opportunities to gain competitive accounts and business and as we restore the supply chain, we'll get after those opportunities and reaccelerate our top line momentum. And then Bob just coming back to your 2017, I would just say that 10% earnings growth in 2017 off of 2016 remains our goal.
Bob Hopkins:
Just how long does this last into 2017, Dan, and that's my last question?
Dan Florin:
I would see some tail effect into the first quarter of 2017, Bob.
Bob Hopkins:
Okay. Thanks a lot for answering, thank you.
Operator:
We'll move on to Matthew O'Brien with Piper Jaffray.
Matthew O'Brien:
Good morning. Thanks for taking the question. Just to follow up a little bit on Bob's question. Is it fair to say that this really is more focussed in just a few areas within large joints from a product perspective and you were seeing such demand for those products that you just weren’t able to kind of meet that demand and as you were kind of integrating and seeing some of these sales disruptions that, that was really the issue or was it more broad-based kind of a cross different products?
Dan Florin:
It was focussed on the key cross sell products very much. So if you think about the Persona system, the demand is very high for that system. The host of cross sell product opportunities that we have on the legacy Biomet hip portfolio, would be another significant example. And then the third category I would say to a lesser degree but still having an impact on the upper extremity side, the comprehensive shoulder system. So, those are all market leading systems and the demand within existing customers as well as competitive accounts is very strong.
Matthew O'Brien:
Okay. And the as a follow-up. On the retention of business side of things, as we get into 2017. And I know you said the demand has been really strong for the products and you feel good about that but just now that you have this hiccup, how do you grab that momentum back which you were seeing and feel comfortable that you can get back to those kind of market growth rates you've been talking about in '17 and beyond.
Dan Florin:
Yes. We're passively working towards addressing the supply issues and I would tell you that the forward visibility of addressing those supply issues combined with the known activities that we have on opportunities that we have for competitive accounts gives us that plan. And the confidence as we on our 2017 that we'll reaccelerate the top line.
Matthew O'Brien:
Right. Thank you.
Operator:
We'll move on to Mike Weinstein with JPMorgan.
Mike Weinstein:
Thank you. Pardon me guys, that I'm still struggling a bit this so. David, explain to me why this wouldn’t have been obvious until in the quarter?
David Dvorak:
Yes. I think that the lack of visibility that we have with forecasting systems safety stocks were burning down. It just became a more profound issue as the quarter progressed. In retrospect we look back and we kind of understand why some of those demand signals weren’t as timely but that's in retrospect. So, we just got to a point as the quarter progressed where we had the shift to limited supply both inventory and instruments to service existing accounts and it took away from the offensive opportunities that we could capitalize on, Mike.
Mike Weinstein:
Okay. And so, sorry I can picture that that you're working down your excess by than you get late in the quarter and you're finding yourself short on product. But if the quantification is right and with a 100 basis points, that still suggests that overall it would have been light which you were expecting to do in the quarter. So, is the quantification accurate, do you think you would have been call it 2.5% organic head in this happen. And that's the case that it's obviously wasn’t your goal for the quarter for the back half of the year.
Dan Florin:
Yes, Mike, this is Dan. I think the other component was the dental performance in the quarter being below our expectation. And at our expectation level, you'd be 3% or thereabouts plus, had dental perform to our internal expectations. I think also with respect to the supply changes to indicate or give a little more colour on the fixes that are coming along. We've been integrating all the back office functions, the supply chain is extraordinarily complex. However, importantly we do have new tools coming online beginning this quarter with integrated global inventory data warehouses which did not exist at that part of the visibility fix that we lacked. We had some interim processes in place that enhanced. They were not as robust as we needed them to be. We also have integrated demand planning tools and production planning tools coming online next quarter. So, those are key foundational elements to the supply chain that are coming online and critical to the fix.
Mike Weinstein:
That and Dan, just one question on the financial side. The tax benefit that we saw this quarter that got you to the EPS numbers, just what should we assume on tax going forward to that's the same amount.
Dan Florin:
Mike, we're at 24% year-to-date. Embedded in our fourth quarter guidance is the tax rate that is just slightly below that and we absolutely believe that to be sustainable. And as we discussed, we see a path to further reduce that over the coming years.
Mike Weinstein:
Understood. Thank you, guys.
Operator:
We'll move on to David Lewis from Morgan Stanley.
David Lewis:
Good morning. I just had a few quick questions here. Dan, just to give the fourth quarter's sort of follow-on to Mike's question. We think about the fourth quarter guidance versus our expectations to sort of down two points. The supply chain is one point. To the incremental point of organic growth depression in the fourth quarter is that conservatism continuation to the dental trends. Can you just square the fourth quarter like you just did in the third?
Dan Florin:
Sure, David. The 1% was the Q3 impact. The Q4 impact as I said is going to be above that, so think of that probably closer to 2% impact to the fourth quarter. So, I'd say that that’s the quantification on the top line impact from the supply chain issues.
David Lewis:
Okay. And then just two more quick ones. Then the third quarter, obviously margins were important in the stories in top 10% is the goal for next year. Gross margins were okay in the third quarter but obviously SG&A spending was higher. Can you just talk about again why third quarter margin compression was so severe and so what the implications are for the fourth quarter?
Dan Florin:
Sure. I would say that in the third quarter, the SG&A margin which decreased or SG&A increased as a percentage of sale 50 basis points. You have to keep in mind the LDR acquisition and the impact of that. So, as David said, we're very pleased with the top line acceleration of Mobi-C. At the same time we've inherited the cost structure and as the team looked to integrate LDR in Zimmer Biomet spine, you'll begin to see leverage come from that integration that’s not in the third quarter, you'll start to see that in the fourth quarter and certainly more significantly as we progress through 2017. So, that leverage from integrating our acquisition is a big contributor to the growth in operating margin next year. Combined with our other growth investments that we've been making during the course of the year, the medical training and education, the specialized sales forces which are driving that SET growth that David described. And then further investments in our Signature Solutions platform which David described as well all which are critical to long-term sustainable growth.
David Lewis:
Okay. And then just one quick one for David. David, I am sorry to keep jumping back on this horse but it's -- was this a situation where you have a Zimmer business and a Biomet business, you have initiatives to shift that mix, and you so for example the Zimmer knee and a Biomet knee, at the end of the quarter more physicians than you expected for one knee over the other, I hate to oversimplify this, but I'm just trying to give a dearth to the sets of how this could happen and how it could happen quickly. And then related David, I would say how is your supply chain and manufacturing with critical parts at this merger. What could you say to investors that give them a confidence that you really feel this is an isolated issue? Thank you, I'll turn back in queue.
David Dvorak:
Sure, David. It is very much the case where we underestimated the degree to which existing customers were ultimately going to be desirous of some of these key focus brands and for the reasons that we've outlined and the fixes that we have in place to address those issues that Dan just referenced for highly confident that we're going to be able to address those supply chain deficiencies and be able to get after the offensive opportunities with a new competitive business and accounts. So, I guess what I would want to focus you on as well, David, is that demand is a terrific problem to have. We're disappointed that we didn’t foresee that demand because it's taken us away from being able to run the kind of offense that we would otherwise be able to run. But these aren’t product GAAP issues. We've got an incredible portfolio and in the natural state of one of these integrations, a complex integration which we would of course seen this. We've got the right fixes in place to get after it. The supply chain will respond and we'll get back, in offensive mode as the month's progress here and have a high degree of confidence and the team's capability to swipe the opportunities that are out ahead of us.
Operator:
We'll move on to Larry Biegelsen with Wells Fargo. Please go ahead, sir.
Larry Biegelsen:
Good morning. Thanks for taking the questions, guys. Can you hear me okay?
David Dvorak:
We can.
Larry Biegelsen:
Great. David, I heard you talk about accelerating growth in 2017. When do you expect to be back to market growth and that 4% target that as you laid out earlier this year and I had to follow-up. Thanks.
David Dvorak:
Yes. We absolutely foresee at or above market growth in 2017 as Dan said. There is likely to be a little bit of a carryover effect of the supply challenges at the beginning of the year. But we would see the year progression quarter-to-quarter throughout 2017 and accelerating growth in light of effect that we will have these supply issues behind us. And we'll provide this specific guidance beyond that, Larry, when we get to the January call.
Larry Biegelsen:
Perfect. And then on dental. Could you give us a little bit more colour on what the issues were? I know you had a recall in the past and you were supposed to return to growth in the second half, I think in 2016. And so, when do you expect to return to growth there and in the past you explore strategic alternatives for dental. Can you talk about whether that is still strategic or as in requirement? Thanks for taking the questions.
David Dvorak:
You're welcome. We believe that there are good value creation opportunities within the dental market. As we've referenced in the past, strategically each of legacy Zimmer and Biomet have been focussed on the so called premium market and we have significant opportunities and we're working to develop the strategies and then execute those strategies increasingly to get after those various market segmentations including the value segment. As the business stands now, commercial execution is key. I would tell you that we had a pretty stable Q2 to Q3 performance within the America's had some drop off outside the United States. And so the team is very focussed on showing up the commercial execution on a global basis. We have a terrific regenerative portfolio for cross sell opportunities. And we would expect to see sequential improvement. I would anticipate that we get into a growth mode but not before 2017. So, we expect to see improvement sequentially from Q3 to Q4 and then get into a growth mode as we're on our 2017.
Larry Biegelsen:
Thanks for taking the questions.
David Dvorak:
Sure.
Operator:
Moving on to Matt Miksic with UBS.
Matt Miksic:
Hi, thanks. So, I had one question on the Medtech Robot platform. And then I'm sorry to say one follow-up on this inventory issue. But on Medtech, David, you mentioned positioning you to potentially explore other applications over time. Can you talk a little bit about where and when and how long something like that you think would take particularly on the large joint side if that's something that you're thinking about. And then as I mentioned I have a follow-up.
David Dvorak:
Yes. The development of any applications for us Matt, on the minimally invasive technologies and soft tissue preserving technologies and the broader portfolio of intelligent instrumentation is going to be driven by proven clinical benefit in a cost efficient way that also addresses the provider's capability on throughput front. And so, those are really the three preconditions, any anatomical site is fair gain for that, but our broad portfolio of intelligent instrumentation puts us in a position to be able to bring the right technologies and converge the right technologies whether those are preoperative planning integrating and or interoperative execution set of technologies in an optimised way. So, this is a piece of the portfolio we think it will become an increasingly important piece of the portfolio but just a piece of the portfolio and we want to bring the right tool to address the issue in a cost effective way. So, as far as forecasting that out, we would expect continue to drive the convergence of these innovative technologies and in the operating periods to come at. And we give updates at appropriate points when applications are developed and gotten at the point where we're doing limited launches moving towards full launches of those other applications. Right now, the Rosa Robotics technology is focussed on brain and spine applications.
Matt Miksic:
Okay. So, this isn’t one of you competitors had a toning application they were working on and talking about probably for at about a couple of years before it finally began to reach the market. Should we sit in a -- do we not expect that kind of plan to land us -- to the pipeline for us a little bit?
David Dvorak:
You shouldn’t expect this to layout our internal innovation pipeline. That’s right, Matt.
Matt Miksic:
Okay, that's fair. I think I get that. So, on the not to kind of speed that works on this supply chain issue, but it has I don’t think we've ever, I'm trying to think of an example that we see like this north be it. And you've managed to a number of large launches and ads and flows between preferred products before. Maybe I remember there was something about before the Biomet the others, something that you were tackling as on your supply chain kind of been a lean out working capital get more efficient. I don’t know if this has anything to do with, greater reliance on preop planning and the visibility that gives in the supply chain. But is this get -- is this sort of an unfortunate consequence of some of your efforts to get more efficient and one step forward and we'll expect to, one step back and two steps forward. Or just some colour would be very helpful on how this how we got here.
David Dvorak:
Yes. I understand your question, Matt. And I would tell you that it's much more simple than that. This is much more simple in regard to appropriate forecasting in having forward visibility. So, the system fixes and infrastructure that Dan referenced earlier during the call are the solutions here. It isn’t driven at all by any kind of innovative go to market or demand signal and transformation, nor is it driven by any kind of consolidation of the portfolios in the form of rationalization. So, I wouldn’t want people to misconstrue that the, yes it’s a complicated operation because these are large product lines and manufacturing facilities. But there isn’t anything other than blocking and tackling that fixes this problem we know we need to do to address it.
Matt Miksic:
Okay, thank you.
David Dvorak:
You're welcome.
Operator:
We'll move on to Joanne Wuensch with BMO Capital Markets.
Joanne Wuensch:
Good morning. Can you hear me okay?
David Dvorak:
We can, Joanne. Good morning.
Joanne Wuensch:
Good morning. Thank you for taking the question. You were able to quantify the tailwind or the impact in the third and the fourth quarter, the commenting that is going to roll into the first quarter. How should we think about that quantification and is there an all clear signal where we don’t have to worry about this anymore?
David Dvorak:
Yes. We wouldn’t expect it to accelerate as we move into next year. So, I think that that quantification that we provided as far as the Q4 impact would be the high water mark and expect it to dissipate as we move into in through 2017, Joanne.
Joanne Wuensch:
Okay. And then it was mentioned if I recall, that the average selling price is or the price pressure may have been somewhat higher than normal during the quarter. Could you please address that?
David Dvorak:
Yes. We just have a little bit of a not pick but consistent with expectations. Primarily as far as the geographic segments go and the America's and Asia Pacific. But nothing that we didn’t anticipate coming into the year or nothing that we didn’t anticipate even coming into the quarter. Part of that Asia Pacific uptick is obviously the biannual adjustments in Japan.
Joanne Wuensch:
Okay. Thank you, very much.
David Dvorak:
You're welcome.
Operator:
Matt Taylor with Barclays has our next question. Please go ahead.
Matt Taylor:
Hi, thanks for taking the question. Can you hear me okay?
David Dvorak:
We can, Matt. Good morning.
Matt Taylor:
Good morning. So, I just wanted to understand from your customers point-of-view, elevated the supply issue that basically they're asking for inventory like Persona and you have to tell them that they have to wait a few weeks. Or can you help us characterize that so we can get the impact on your customers look the risk that you lose anybody because of the [indiscernible]?
David Dvorak:
That risk will be minimised. I mean, this is part of the reason that has any of those signals we receive back we back off of some of the offense of deployments to make sure that we're taking care of the existing customers. So, that's the priority. It's a good question. And I would tell you that our entire organization is very focused on addressing any of those desires with the historic customers for the business side of legacy, Zimmer or Biomet.
Matt Taylor:
Then on the fixes that you have with forecasting in the moment. Can you give us a sense of, what are the kind of long holes in the tent there. I like to give some upside or downside to your expectation, that will be $3 in a two months.
Dan Florin:
Matt, this is Dan. If I mention some of the fixes being a global inventory data warehouse that is in user acceptance training as we speak. So, we expect that to come online in the coming weeks. That immediately gives us the type of global visibility to finish goods in inventory levels around the US and around the world. That's critical to that comes online in the coming weeks. The so I think we're very low risk of that going purely based on the testing that's been done today. The integrated demand planning tools come online shortly after the new year and based on the learnings over the past few months, needless to say a lot of focus on the process for that and then the deployment of these tools were we're deploying our approve tool. So confident that we're going to be able to get that up and running without a glitches. Importantly over the past month, we significantly ramped up production levels but given lead times from vendors and production lead times that just takes time to build inventory and replenish those safety stock levels. But all of the above were aggressively dealing with and have been for the past several weeks.
Matt Taylor:
Okay. Thank you.
Operator:
We'll move next to Richard Newitter with Leerink Partners.
Richard Newitter:
Hi, thanks for taking the questions. Maybe just to turn away from the supply issues for a moment. You mentioned some initiatives to try to tell your solution a bit more to the bundle payments that we're seeing take hold of the CJR. You acquired this respond well business. Can you talk a little bit about how we can expect these types of solutions to just fit into your overall strategy and how we should expect them to generate sales or what the business model is there?
David Dvorak:
Sure, we take the form of much broader and deeper partnerships with the hospital customers. And I would tell you the discussions that we've had which to-date have been focussed primarily on large academic institutions have been very positive. So, we would enter into a deep partnership that could include risk sharing in an appropriate manner to optimise the quality of care for patients. And as well address the economic pressures that are on these customers as they get transitioned over to a more value base system. To do that well, obviously, it requires an end-to-end management in the episode of care. And that's where the patient engagement tools become so important. Prehab is important, education, patient surgeon communications, obviously a really bright light has been shining as of late. Because of CJR, the post discharge cost that are incurred and that’s where the teller rehabilitation and leveraging technologies that lead to a better patient outcome, but do that on a cost effective way can become so meaningful. So, that product portfolio across the continuum of care including these services and solutions including our couple of decades of experience through our Accelero consulting services that help lean out processes and ensure that the quality of care is raised and it's done efficiently and throughput is drive through these systems is what signature solutions is all about. And as I said, it’s a message that's really resonating. I think they were in a unique position as we participate in over 1.5 million procedures across the globe on just the large showing side alone to understand what best practises can be transferred from one institution to another. And then ultimately with the appropriate structure on an end-to-end basis. We're going to be able to along with our hospital customers draw data that will lead to continuous improvement and refinements of how the care is delivered. So, we love the opportunity. We think that we can be a big part of the solution for the hospitals going forward. And the deeper partnerships in the Zimmer Biomet Signature Solutions is the umbrella that allows us to bring those solutions to the customers.
Richard Newitter:
Okay. And just one follow up on LDR. I think Dan, you had mentioned, leveraging that acquisition into the fourth quarter in a more meaningful in '17 as a reason for confidence and operating profit growth through acceleration. I guess my question just there is, do you -- what's your confidence level that you're going to be able to maintain the salesforce in what always is tricky with spot acquisitions and what level of confidence do you have that we won't see any surprises kind of for that business to potentially alter that margin outlook. Thanks.
Dan Florin:
Sure. And we will do nothing to impede the momentum of Mobi-C. We can assure you that the opportunity is really keeping mind that the Zimmer Biomet spine business still in the process of being integrated, you bring LDR into that and that and now we have an opportunity to further design the right or structure for robust growth in the right level of supporting infrastructure. So, it's really you have to think about Zimmer Biomet LDR all emerging together in from a back office perspective and so forth. But we will do nothing to impede the growth. In the LDR portfolio and then capitalize on the cross sell opportunities that exist between the Zimmer Biomet portfolio with Mobi-C. Very exciting and how the confident in our ability to drive the top line while delivering on the integration and the synergies.
David Dvorak:
Cray, we have time for one additional question.
Operator:
Thank you. We'll take that from Glenn Novarro with RBC Capital Markets.
Glenn Novarro:
Hi. Two questions. One, back into the temper you guys were on the conference trail and you highlighted the FX headwinds for 2017 on the EPS line. So, can you give us an update on the FX impact in terms of EPS for 2017 and what are the offsets? And I have a follow-up.
David Dvorak:
Sure, Glenn. The impact on 2017 is still the same and we've characterized that roughly in the neighbourhood of a 4% headwind to EPS growth next year. And that's still the case. We continue to feel good about the Biomet synergies which offset that. And then some of the other activities that will be driving to work towards that 10% goal that I described before. So, nothing had changed in that regard.
Glenn Novarro:
Okay. And then, just on the salesforce back at AAOS, there was a lot of chatter about the Zimmer reps and resume's out in the field. But Dave, I think on the call you said that you were a mid-adder of sales reps this quarter. So, can you quantify and where is this coming. Is it coming particularly in knees and hips? Thanks.
David Dvorak:
Sure Glenn. We have been a mid-adder as you said in the first quarter of this year, in the second quarter of this year and again in the third quarter of this year. And it's across all product categories Glenn, if there is a lot of focus obviously consistent with as we've been talking about building up the specialize salesforces and so the non-large showing categories as well had be recipients of the continuous filled out of the salesforce. And I think that you're just beginning to see the science of the productivity of those specialized salesforces is evidenced by the continued improvement of the SET category. And that was global improvement as is our build out of the specialized sale force, since it's very much a global offense and strategy.
David Dvorak:
So, with that, I'd like to thank everyone for joining the call today and for your continued interest and support for Zimmer Biomet. We look forward to speaking with you on our fourth quarter conference call. I'll turn the call back to you, Careen.
Operator:
Thank you, sir. And thank you again for participating in today's conference call. You may now disconnect.
Executives:
Mike Marshall - VP of IR and Treasurer David Dvorak - CEO Dan Florin - CFO
Analysts:
Bob Hopkins - Bank of America Merrill Lynch Craig Bijou - Wells Fargo Securities Mike Weinstein - JPMorgan David Lewis - Morgan Stanley Young Li - Barclays Capital Kyle Rose - Canaccord Genuity Joanne Wuensch - BMO Capital Markets
Operator:
Good morning. I would like to turn the call over to Bob Marshall, Vice President, Investor Relations and Treasurer. Mr. Marshall, you may begin your call.
Mike Marshall:
Thank you, Sara. Good morning and welcome to Zimmer Biomet's second quarter 2016 earnings conference call. I'm here with our CEO, David Dvorak and our CFO Dan Florin. Before we start, I'd like to remind you that our discussions during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please refer to our SEC filings for a detailed discussions of these risks and uncertainties. During our call, we will compare revenues on a constant currency adjusted pro forma basis. This means revenues for the prior-year periods have been adjusted to reflect the inclusion of Biomet revenues and the impact to the previously announced divestiture revenues. Additionally, expense ratios and related margin analysis through operating profit will be computed on the basis of an adjusted pro forma financials, as revised, adjusted in all periods for inventory step-up and other inventory and manufacturing-related charges, special items, intangible asset amortization, financing and other expenses related to the Biomet merger and current tax adjustments, as applicable. Reconciliations to non-GAAP financial measures discussed during our call to the most directly comparable GAAP financial measures are available on our website at, investor.zimmerbiomet.com. With that, I'll now turn the call over to David.
David Dvorak:
Thanks Bob. This morning, I will review our second quarter financial results and key highlights from our performance as well as the ongoing development and expansion of our musculoskeletal portfolio. Dan will then provide additional financial details and discuss our updated guidance. Before I launch into these topics, however, I would like to take a moment to reflect on the one-year anniversary of the formation of Zimmer Biomet. Throughout this past year, we've continued to be guided by our long-standing value creation framework which focuses on investing for sustainable growth, driving operational efficiencies and redeploying capital in a disciplined matter. We successfully integrated and leveraged the combined expertise and cultures of the two organizations, while executing on a highly complementary portfolio of technologies, services and solutions. Our financial results have provided the tangible proof points that Zimmer Biomet reflects our initial vision of an ideal fit. Our Company has reached an important inflection point, having successfully reestablished top-line momentum by beginning to capture the promise of the attractive cross-selling opportunities inherent in our merger, in addition to successfully delivering on our synergy commitments. We're now poised to move forward with our plans which include the acceleration of our commercial and innovation strategic priorities. These priorities are designed to further enhance and sustain our growth well into the future. Consistent with this progress, Zimmer Biomet generated solid revenue acceleration in the second quarter, again above the top end of our expectations, further validating our strategies to achieve above-market revenue growth by the close of 2016. Our steady advance towards this goal demonstrates the increasing productivity and focused execution of our commercial organization and for the balance of the year, will continue to exploit the opportunities presented by our differentiated musculoskeletal portfolio. Turning briefly to market conditions, in the second quarter, the demand across the globe for musculoskeletal solutions continued to grow at a steady pace, in line with our expectations and consistent with recent quarters. With regard to pricing, we experienced negative price pressure of 1.2% in the quarter, consistent with broader trends throughout 2016. Against this backdrop, Zimmer Biomet delivered second quarter consolidated net sales of $1.93 billion which represented an increase of 65.6% on a reported basis and 4.5% adjusted compared to the prior-year quarter. We increased sales in each of our segments, with Americas up 3.6%, Europe, Middle East and Africa regions growing 4.5%; and the Asia-Pacific region delivering 8.2% growth. Within our consolidated results, Zimmer Biomet's knee category grew sales 5.0% in the second quarter, reflecting positive volume and mix of 6.5% and negative price of 1.5%. Our U.S. knee business continued to deliver solid results which contributed to a sales increase of 3.0% in the Americas. We also achieved strong revenues in markets across the Asia-Pacific and Europe, Middle East and Africa regions, where we increased sales over the prior-year period by 9.6% and 7.1%, respectively. As anticipated, the cross-selling opportunities of our market-leading knee portfolio continue to drive growth, led by the ongoing sales performance of premium reconstructive systems such as our flagship Persona, the Personalized Knee System and the Vanguard 360 Revision Knee System. In addition, during the quarter, we marked the 40th anniversary of the launch of the Oxford Partial Knee, the most widely used and clinically proven partial-knee replacement in the world which has been used in more than 600,000 surgeries across 50 countries and featured in more than 280 published studies. And, as part of our commitment to continuous product innovation, during the second quarter, we released a series of next-generation enhancements to our OSS orthopedic Salvage System. Advancing this unique solution for salvage revision procedures and oncologic applications. As we look to the second half of the year, we will further leverage the commercial opportunities of our knee portfolio for the ongoing growth of this important category. Turning to our market-leading hip business, we accelerated consolidated sales growth to 3.2% in the second quarter, including positive volume and mix of 5.4% and negative price of 2.2%. Hip revenues grew, 8.1% in the Asia-Pacific region; 3.6% in Europe, Middle East and Africa; and 1.5% in the Americas compared to the prior-year quarter. The second quarter progress of our hip category was led by our innovative Taperloc Complete System and our comprehensive revision portfolio in addition to our Vitamin E-infused advanced bearing materials, Vivacit-E and E1. During the quarter, our sales channel focused on increasing the adoption of differentiated recent additions to our hip offerings, including the Echo Bi-Metric Microplasty Stem and the Arcos One-Piece Revision System. We also continue to gain traction with the G7 Dual Mobility Construct. This unique solution is designed to achieve stability with optimal range of motion and is compatible with a full line of fixation options within our G7 Acetabular System. We plan to further deliver hip growth in the second half of the year, backed by a diversified portfolio of solutions that address a broad spectrum of clinical challenges and surgical approaches. Importantly, we increased our S.E.T. revenues by an impressive 7.2% in the second quarter, supported by the positive U.S. performances of every business within this category. In Surgical, our sales were again strengthened by our offerings for the OR suite, led by the Transposal Fluid Waste Management System and the ATS Automatic Tourniquet System. From our Sports Medicine portfolio, we continue to deliver attractive growth, with our joint preserving Gel-One Hyaluronate Injection and the Subchondroplasty procedure in addition to a solid initial quarter of results for our Quattro Link Knotless Anchors and XTRAFIX System from our recently expanded line of Advanced Soft Tissue Repair and Reconstruction Solutions. Within our market-leading extremities business, we have been pleased with the ongoing sales performance of our Comprehensive Total Shoulder System and the Nexel Total Elbow. And through the increased productivity of our trauma commercial teams, we sequentially improved our trauma performance, with steady sales of our AFFIXU.S. Hip Fracture Nail System and a Natural Nail System. Going forward, we plan to continue accelerating growth in our SET category as part of our global strategy for a diversified and sustainable revenue platform. Zimmer Biomet dental sales decreased 0.8% in the second quarter, representing a stabilizing sequential performance that had set the stage for expected growth in the second half of the year. In addition to benefiting from the increased harmonization of our dental commercial channel, during the second quarter, we successfully resolved a supply disruption associated with a voluntary product action that occurred in the fourth quarter of 2015. We also continued to improve sales acrossed our dental portfolio, including our market-leading regenerative solutions. From our dental commercial pipeline, we've been pleased with the ongoing U.S. launch of the 3i T3 Short Implant designed for challenging vertical grafting procedures and the 3.1 millimeter diameter aesthetic implant for narrow anterior sites. We will remain focused on the improvement of our dental business in the second half of the year, leveraging our scale, expertise and competitive portfolio of dental solutions. Our spine, craniomaxillofacial and thoracic category increased sales 1.4% over the prior-year quarter. Our craniomaxillofacial and thoracic team continues to grow sales of our recently launched RibFix Blu System and OmniMax MMF System, while delivering strong results with our TraumaOne and SternaLock Blu Systems. In our spine business, we continued to deliver steady revenues with the Polaris Spinal System as well as the Timberline Lateral Fusion System, an offering which we enhanced during the quarter with valuable expansions. Our spine results were also supported by sales of our recently launched Vitality Spinal Fixation System. Going forward, we're well-positioned to capture the opportunities resulting from our acquisition of LDR Spine. By joining together with this successful and innovative international spine company, we're enhancing the scale, portfolio and capabilities of our global spine business, including an immediate leadership position in cervical disc replacement, the fastest growing segment of the $10 billion spine market. We have also gained a number of valuable new offerings to expand our minimally invasive technologies. In addition, earlier this month, we acquired a controlling share of French surgical robotics innovator, Medtech SA, including its Rosa Robotics Platform for a range of minimally invasive brain, neurological and spinal procedures. This advanced combination of robotics technology, with surgical navigation, will further diversify our spine and CMF portfolio as well as bolster our strategy to offer the industry's broadest range of intelligent instrumentation options. Furthermore, we see significant potential to leverage this platform technology for additional anatomical sites in the future. Upon acquiring the remaining Medtech shares in the coming months, our integration priorities will focus on building a strong foundation to support the expansion of this platform technology across our musculoskeletal portfolio. We will prioritize future application development and ensure that R&D resources are expanded appropriately. We will also ensure the key capabilities and support functions, such as manufacturing and quality systems, are built out in a manner that will support our growth plans. These and other highly complementary transactions, in combination with the diversified internal pipeline, are accelerating our strategies for delivering sustainable longer term revenue growth across all musculoskeletal markets. The ongoing expansion of our personalized technologies, services and solutions also allows us to play a meaningful role in transforming healthcare by addressing the evolving needs of the sector. To that end, earlier this week, we were pleased to unveil our latest offering, Signature Solutions. This comprehensive suite of clinical services and technologies is designed to assist hospitals and medical practices to seamlessly transition to value-based healthcare models by maintaining excellent patient outcomes while maximizing procedural and cost efficiencies across the entire episode of care. Built on our nine decades of musculoskeletal expertise, Signature Solutions will combine Zimmer Biomet's established consulting platform with a strategically curated suite of technologies and services that drives improvement across every aspect of the healthcare value equation. We will initially offer Signature Solutions to musculoskeletal service lines that select academic facilities in the United States, leading the way for a broader release scheduled for 2017. Importantly, we expect the expansion of Signature Solutions to coincide with an increased focus on knee and hip replacement at U.S. facilities participating in Medicare's CJR payment model. Through innovative service-driven offerings such as this, we're deepening our commitment to advancing standards of musculoskeletal care and enhancing our partnerships with healthcare stakeholders. With that, I will turn it over to Dan, who will continue this discussion in greater detail as well as review our revenue and earnings guidance. Dan?
Dan Florin:
Thank you, David. I will review our second quarter performance in more detail and then provide additional information related to our second-half and full-year 2016 sales and earnings guidance. Our total revenues for the second quarter were $1.934 billion, an increase of 4.5% constant currency compared to the second quarter of 2015 on an adjusted pro forma basis. The net currency impact for the quarter on revenue was not material to consolidated results. We had just over one additional billing day in the quarter as compared to the second quarter of 2015 which contributed approximately 190 basis points of growth in the quarter on a consolidated basis. The billing day differences varied by geographic segment with the Americas and EMEA having one and two extra billing days, respectively. There was essentially no impact in the Asia-Pacific region. Our adjusted gross profit margin was 75% for the quarter and 80 basis points lower when compared to the prior-year adjusted pro forma results, due to the impact of unfavorable foreign currency and price declines. The Company's R&D expense was 4.6% of revenue at $88.6 million. Adjusted selling, general and administrative expenses were $732 million in the second quarter or 37.8% of sales which was 220 basis points lower than the comparable period in the prior year on an adjusted pro forma basis. SG&A leverage was again driven by our synergy initiatives, partially offset by ongoing investments in our specialized sales forces around the globe as well as additional medical training and education programs. We remain on track to deliver cumulative net EBIT merger synergies of $225 million by the end of 2016 which is ahead of our expectations at the time of the merger closing and consistent with our full year of guidance. In the quarter, the Company recorded pre-tax charges of $430 million in special items, primarily related to the Biomet acquisition, including $307 million of non-cash amortization and inventory step-up charges as well as integration-related expenses. Adjusted second quarter 2016 figures in the earnings release exclude the impact of these charges. A full reconciliation of reported net earnings to adjusted net earnings is included in this morning's press release. Adjusted operating profit in the quarter amounted to approximately $630 million or 32.6% of sales which was an increase of 160 basis points when compared to the prior-year period. Net interest expense and other non-operating expenses totaled $89.6 million in the quarter. Our adjusted net earnings were $407.1 million for the second quarter, an increase of 47% compared to the prior-year period. Adjusted diluted earnings per share increased 27.8% to $2.02 on 201.9 million weighted average fully diluted shares outstanding. Our adjusted effective tax rate for the quarter was 24.7% which included approximately 70 basis points of benefit from the early adoption of a new tax accounting rules for stock-based compensation. With the early adoption of the new accounting standard we also revised our Q1 tax rate by 50 basis points which resulted in an incremental 0.01% or $0.01 to earnings per share in the first quarter. Operating cash flow for the quarter amounted to $380 million which included $101 million of cash expenditures for integration and initiatives related to our synergy program. Capital expenditures for the quarter totaled $118 million, including $72 million for instruments and $46 million for property, plant and equipment. Our free cash flow in the second quarter was approximately $262 million compared to $115 million in the second quarter of 2015 and was in line with our expectations. During the quarter, the Company repaid $100 million on our term loan, reflecting $1 billion of debt repayment since the closing of the Biomet transaction one year ago. I would like to now review our guidance. I will provide updated revenue and adjusted earnings per share guidance for the full year as well as our expectations for the second half of the year. Our guidance reflects continued accelerating sales momentum, consistent with our prior expectations plus the addition of exciting new technologies, such as the LDR portfolio which we believe positions us well for sustained above-market growth for years to come. For a full-year 2016, we now estimate revenues to be in a range of $7.68 billion to $7.715 billion or an increase of approximately 28% on a reported basis and 3.0% to 3.5% on an adjusted pro forma basis, in each case as compared to the prior year. The adjusted pro forma revenue guidance is inclusive of approximately 100 basis points of contributions related to the LDR transaction. We now expect foreign currency translation to decrease revenue in 2016 by approximately 0.5% compared to our previous estimate of 1.0%, with the Japanese Yen strengthening against the U.S. Dollar, partially offset by the weakening British Pound. Therefore organic revenue growth, on a constant currency adjusted pro forma basis, is now expected to be in a range of 2.5% to 3.0%. Previously, the Company estimated full-year revenue growth to be in a range of 2.0% to 3.0% on a similar basis. Turning to the full year of P&L, after updating our assumptions to reflect our recent acquisitions and planned strategic investments as well as foreign currency exchange rates, our full-year adjusted diluted earnings per share is now expected to be in a range of $7.90 to $8, the achievement of which would mark our fifth consecutive year of expanded adjusted operating margins. Our reported earnings per share are expected to be in a range of $1.50 to $1.75 after giving us back to our year-to-date results and anticipated special items in the second half. Special items are largely associated with non-cash amortization, costs incurred to capture net targets and acquisition-integration expenses. As we look to the second half of the year, revenue growth is expected to be in a range of 4.0% to 5.0% for both the third and fourth quarter with one less billing day in Q4 compared to the prior year, a 150 basis point headwind. Foreign exchange is estimated to decrease revenue in both quarters by about 30 basis points. Reported revenue is expected to be a dollar range of $1.830 billion to $1.850 billion for the third quarter and $2.010 billion to $2.030 billion in the fourth quarter. Constant currency growth on a day adjusted basis is expected to be in a range of 4.3% to 5.3% for the third quarter and 5.8% to 6.8% for the fourth quarter. Excluding the impact of the LDR acquisition, constant currency day-rate growth is expected to be in a range of 2.5% to 3.5% and 3.5% to 4.5% for Q3 and Q4, respectively. Working down the P&L, during the second half of 2016, we expect gross margins to be a range of 75.0% to 75.7%, consistent with the first half of the year. R&D and SG&A as a percentage of sales are expected to increase from the first half of the year to reflect recent acquisitions and planned strategic investments. We now estimate R&D expense to be in a range of 4.7% to 5.2% of sales in the second half and SG&A expense to be in a range of 37.5% to 39.5%. We expect higher expense ratios in Q3 and lower in Q4 to properly reflect seasonality. The effective tax rate in the second half of the year is expected to be approximately 25%. To wrap up, we expect Q3 adjusted earnings per share to be in a range of $1.76 to $1.80 and Q4 to be in a range of $2.11 to $2.17. Finally, please note that our guidance does not include any impact from other potential business development transactions or unforeseen events. David, I will turn the call back over to you.
David Dvorak:
Thanks, Dan. Zimmer Biomet sales performance in the first half of 2016 demonstrated the effectiveness and coordination of our industry-leading commercial organization, reinforcing our confidence for exiting the year at above-market growth rates. In addition to promising opportunities across our portfolio, we will continue bringing differentiated new products to market in 2016, including technologies, services and solutions that represent compelling value in the evolving healthcare environment. These internal developments from our R&D pipeline will be joined at the second half of the year by new offerings from our recent acquisitions which further enhance our portfolio's leadership position. And now I would like to ask Sara to begin the Q&A portion of our call.
Operator:
[Operator Instructions]. Mr. Bob Hopkins from Bank of America. Please go ahead with your question.
Bob Hopkins:
So congrats on the progress this quarter; nice to see. I've got a couple, first, a clarifying question just for the guidance because obviously, there's a lot of moving parts here in terms of selling days and pro forma numbers. Dan, in Q1 of this year organically, you grew 1.2% on a same-day selling basis. I think that number for Q2 is 2.6%; is that right?
Dan Florin:
2.5%, Bob. Yes.
Bob Hopkins:
Okay. So 2.5%. So 1.2% and then 2.5% and then the guidance for Q3 and Q4 on the same basis is 2.5% to 3.5% and then 3.5% to 4.5%; is that right?
Dan Florin:
That's correct.
Bob Hopkins:
Okay, so 1.2% going to 2.5% and then up from there and then up from there again. Okay. And then just on a selling day basis in Q1, just so we have it correctly, I think you said in the Americas, there was one extra day and in EMEA, there were two?
Dan Florin:
In Q2, that is correct. One extra day in the Americas, two extra days in EMEA.
Bob Hopkins:
More substantively, I was just wondering if you could talk a little bit about U.S. hip and knees. Obviously, across the organization, you had nice acceleration in growth. On a selling day basis, if there was one spot where I thought there might be a little momentum, it was maybe U.S.-Americas business for hips. So I'm wondering, David, if you could just elaborate on what's going on in the Americas? Is U.S. strong and then maybe some of the other territories in Americas a little bit weaker? Just maybe talk about the U.S. hip market and the U.S. knee market separate from the other Americas. Thank you.
David Dvorak:
Sure, Bob. We continue to make progress in closing the gap to market in both large joint categories in the United States, probably more substantial progress sequentially from the first quarter to the second quarter in hips but that stands to reason relative to some of the product launches that have already come out this year, we're finding a lot of traction with strengthening our revision line. As we talked about in the past, the Biomet portfolio greatly shores up some of the gaps that we had on the legacy Zimmer side and the commercial teams are taking advantage of that on the hip side. We probably saw an earlier recovery of the Knee business on the U.S. front and then that was sustained sequentially from Q1 to Q2. So we feel good about the momentum. We have a lot of opportunity going forward. Both large joint categories in the United States and obviously, these are categories that have performed quite well outside of the U.S. for us, particularly the Knee business over the course of the last couple of quarters now.
Bob Hopkins:
How about the tone of the U.S. market though for hips and knees, now that we have seen a bunch of players report? What is your view on Q2 market growth trends for U.S. hips and knees?
David Dvorak:
I don't see there being a substantial adjustment to the pace. Obviously, these demands are consistent in the global markets, quite stable in that regard as it relates to the U.S. in particular. You have a little bit of a shift from Q1 to Q2, just on billing days and I think that everyone Bob talks about the billing days in absolute terms because that's the cleanest way to talk about it. But you have to be careful about not acknowledging that there are some shifts in billing day mix from Q1 to Q2 and if Easter hits at a particular point in time and Good Friday gets pushed from Q1, Q2, back and forth from one year to the next that can have some dynamics. So I think you're better off measuring the pace and stability of that U.S. market across the longer period rather than just isolating transition from Q1 to Q2.
Operator:
[Operator Instructions]. Mr. Larry Biegelsen from Wells Fargo. Please go ahead with your question, sir.
Craig Bijou:
It is actually Craig on for Larry. I wanted to start at Medtronics Analyst Day, Medtronic talked about, for the first time publicly, introducing lower price knee and hip implants. There are also a couple of other players that are looking to go the less expensive implant route. And I know within CJR, it's been talked about numerous times that the focus is going to be on post-acute care savings. But you're going to have these companies that are going to the hospitals with less expensive implant offerings so I did just want to get your thoughts on how that model could impact the industry and if you guys have a, would have a response to that?
David Dvorak:
Sure Craig. I think that there's nothing new in that announcement. Obviously, across the globe, we compete against a large number of companies, some of whom are taking that segment of the market by way of focus and if anything, I would tell you that we're better positioned than ever because of the Zimmer Biomet combination. We have not only the capability to position our systems at a price point to meet the clinical needs and the demands of customers to match anyone but we're doing that with clinically proven products that have been out for, in the case of NexGen, 20 years and our service capabilities at the same time, with our scale, can deliver that product in a cost-efficient way, in a manner that meets the service needs of those customers as well. So nothing new in the way of that announcement, obviously, we take any launch seriously. We pay a lot of attention to the competitive environment and do that in a very respectful manner because that leads us to running the business in a more confident fashion but there isn't anything about that particular announcement that we find to be game-changing relative to the marketplace. I would go on, I guess Craig to tell you that I think to the extent that the value-based models are going to become more significant in a U.S. market and this is the case in some of the OU.S. markets that we have operated in for a long, long time. If someone grabs a product to save a few dollars and ends up with a clinical problem and remember the patients at the same time, they're becoming much better educated and their expectations for a return to the lifestyle that they have a vision with respect to getting to, is better informed than ever. Using the wrong product, ending up with the wrong patient result, the reputational damage and quite soon, the economic consequences of doing that are going to be dialed in at a much more significant way. So again, proven clinical technologies are going to be more important in the environment that we're going to be operating in rather than less and I think that whether it's surgeons or hospital administrators, they are going to be making business decisions in accordance with that environment in which they are operating.
Craig Bijou:
And then just on the Medtech acquisition or the investment in the subsequent acquisition, I wanted to ask your thoughts about you mentioned, well, obviously spine, the spine application from Medtech and then potentially moving into other anatomical areas. So I want to ask, from a strategic point of view, why robotics works in spine and some of the other anatomical areas but may not work in hip and knee, as you've spoken numerous times about one of your competitors and the robot that they acquired. So I just wanted to understand some of the differences between the different segments within broader ortho.
David Dvorak:
Sure. This is all part of a decade-long effort that we've had underway to offer the marketplace with the broadest array of intelligent instruments and as we've said all along, we're agnostic as to the form that, that technology takes but what's important to us is to create value with these technologies and think about that in three key areas. First and foremost, is to improve the quality of outcomes. Secondly, to ensure that, that technology is efficient and creates value for our customers. And then thirdly and this is going to become increasingly important in the value-based world that we're going to be operating within, is patient volume capture. So that means the clinical outcome can't go backwards. The cost of the technology can't be positioned in a way where it doesn't provide the customer with a return and it certainly can't prolong a lot of times or the terms of those ORs in a manner that the cost of the patient volume to decline in that important service line for the customers. So with all of that, by way of background, we obviously in Patient-Specific Instruments and iASSIST and eLIBRA, et cetera and the more traditional navigation have made significant investments and do thousands and thousands of procedures that are supported by those technologies. To the extent that robotics can augment where it is a value creator, the cases that are being done, then that is enough for it is worth putting forth and we believe that it will create value. Now, this is a technology that is very well advanced, the better part of a couple of decades of effort that have gone into it. And it really augments and complements what we've been doing out of our Montreal operations for over a decade, what they've been doing for two decades as ORTHOsoft, the navigation of the development of the iASSIST technology. So very complementary; it will be integrated into those technologies but it has to create value. The Medtech Group has done a good job of taking that technology forward, addressing technical challenges that existed when we looked at similar technologies over the last many years and that is the difference maker to us. So it has the potential of being leverageable across other muscular skeletal sites but obviously, at the start point, we'll focus on the current applications and the beginnings of the launch in the spine space and do that in a way where we make sure that we're getting the foundation right to ensure that we don't have hiccups or hit speed bumps as we roll out those technologies and the applications across various anatomical sites. So if you look at spine, specifically, obviously the success rates, patient satisfaction rates are quite different than knees and hips. And this is one of the things that we can do along with LDRs, Mobi-C along with LDRs, minimally invasive technologies and implants to provide a better patient outcome. And so we will be focused in those areas first and then over time to the extent that we can create value with this technology in other areas, you should expect to see those applications get launched as well, Craig.
Operator:
Mr. Mike Weinstein from JPMorgan. Please go ahead with your question, sir.
Mike Weinstein:
So David, when I look at your 2Q performance and the acceleration that we're seeing in the business, part of what, I think, impresses me most is what we're starting to see in the SET business this quarter and if you think about the second half of the year and the guidance for the sequential acceleration in the top line growth of the Company, is SET the number one driver; is that how we should think about it?
David Dvorak:
It is broad-based, Mike. I would tell you quite literally, across every business unit, we expect and have opportunities to accelerate the growth so we would expect to sustain that level and perhaps pick up the pace even within SET because we love our opportunities there and yet we see opportunities in the other product categories, just the same. At SET side, we talked about this at the point of announcing the Biomet combination and again, these were business units where, in market subsegments where we had lower share, we had scale challenges and some product gaps, Biomet was in the exact same position and it really was a complementary fit when you brought those product lines together, the product pipelines together. And importantly, the capability given the competitiveness of that combined portfolio in each of those product categories to justify building out more specialized sales forces. I tell you that, that is just now what you're starting to see the benefit of and that's a big difference maker so you've got this competitive bag and historically organizations that were primarily driven by generalist and are in the future and you're starting to see good results of this going to be driven by sales force specialization where appropriate. It is going to continue to be a growth engine for us. I think what you will see is, spine will take that form as we get through the LDR integration as well.
Mike Weinstein:
David, the timing of creating these specialized sales forces in trauma and maybe just to clarify, so it's trauma, upper and lower extremities, sports medicine, where you going to have specialized sales forces? And what is the timing of having those in place?
David Dvorak:
In all of those areas and then at a group like surgical, obviously, we're already there with spine, dental, so anything that's non-large joint, you should expect some form of specialization, whether those are product specialists or outright direct reps that are focused exclusively on those product categories. And obviously, the product category and the geography will dictate the level of specialization but they exist today. It was one of the things that we drove, Mike, in the integration early on is to make critical decisions that would optimize our performance across all of these product categories. And since then, we've been adding more specialized reps to each of these categories and we're up on a net basis substantially in the non-large joint categories; in fact, we're up on a net basis, both Q1 and Q2 on the large joint side, too. So this is just the beginning of driving this momentum and we're really enthusiastic about what we're seeing.
Mike Weinstein:
David, I think just on this topic, I think probably a lot of people don't appreciate the challenge in some those businesses historically for Zimmer of competing with companies that have specialized organizations, whether it's trauma or in extremities. Ones that were -- had larger footprints or were able to make those investments before seem to have the upper hand a lot of times in those markets relative to where Zimmer which was working off a smaller footprint in some of those markets. But obviously, this very large reconstructive presence. That moved to the specialized effort by Zimmer is a big change and should have a big impact on the business, I would think.
David Dvorak:
I think that is right, Mike and I think it was something that was undervalued at the time that we announced the deal. We articulated that is a strategy but understandably, people want to see you get far enough into executing that strategy and putting some results on the scoreboard before they can fully value it. This is installment one here in Q2 for the new Zimmer Biomet for these kinds of results.
Operator:
Mr. David Lewis from Morgan Stanley. Please go ahead with your question, sir.
David Lewis:
Just a couple of questions, maybe I will start with Dan. So Dan, you increased guidance for operating expenses in the back half of the year. It does sound like from the commentary most of that was tied to LDR but I guess, just thinking about the accelerating revenue and the drop through to the bottom line in the back half of the year, it sounds like you certainly believe organic growth will accelerate. Are there other investments that we should be thinking about you making to grow the business in the back half that would prevent drop-through in margin progression back half this year into 2017?
Dan Florin:
Sure, David. I think, first, importantly, as we said in our prepared remarks, with the Biomet integration, solidly on track and accelerating revenue growth that it really does put us in a position to make important strategic investments and certainly, the LDR acquisition being part of that effort so very excited to have LDR in our spine portfolio. It's a big opportunity for us to transform our spine business. As you know, as an independent company, LDR was generating operating losses which we're absorbing in the second half of the year and as we eliminate redundancies and integrate the back office, et cetera, we will grow that business and that will begin to turn. As we said at the time of the deal announcement, the transaction is expected to be neutral to net income in 2017. So for the back half of 2016 and the full year of 2016, we're delivering on towards the high end of our original EPS guidance while also making strategic investments like LDR, like Medtech, Signature Solutions which David referred to on top of specialized sales forces and medical training and education. So Those are the types of investments that we're able to make while delivering on our EPS and we think that is the smart investment to make and really positions us well going into 2017 with that accelerating topline.
David Lewis:
And then David, just thinking about your comments on growth, both on a conference call for LDR as well as this morning, I don't want to put the cart before the horse here, we're only halfway through the year and organic growth is moving in the right direction. It just seems like when you're talking about relative to the other businesses, first half of the year was Recon stability; second half of the year was all the improvement other businesses like SET and spine. It just feels like if this momentum continues over the next two quarters, you should exceed the top end of your organic guidance range and I guess, I'm trying to take your qualitative momentum commentary with the guidance. You think there's a lot of momentum, I think if that carries forward, you do better than the top end of the guidance. Is this just baby steps or is there anything you can think of, either in Recon or other businesses that potentially are headwinds in the back half of the year that we may not be thinking about relative to the momentum that looks obvious?
David Dvorak:
There really isn't anything that is significant in our minds. Obviously, the world's a dynamic place but we're lining up the sequential quarters of improvement. It's a big business so points of growth are meaningful numbers. I think we're being prudent about the pace of improvement, David, between now and the end of the year and what's really important to us is to make sure that we're doing this methodically so that it leads to a sustainable and durable growth rate on the topline as we exit 2016 and into 2017. Again, you look at the clean view of the organic growth rate that we spoke about and you've got nice steps that are contemplated for both Q3 and Q4 and then that creates a nice jump off point for 2017 which is absolutely consistent with what we came into the year, articulating we would accomplish.
David Lewis:
Okay and then David, just one last thing on just the environment. Relative to pricing, it was a little worse this quarter but frankly, it's still tracking at lower rates than we've seen over the last few years. Are we at a new normal level for pricing that is a little better or is it just simply too early to tell? Thank you and I'll jump back in queue.
David Dvorak:
Sure, David. I think it's too early to tell, notwithstanding the fact that it is the case that over the course of the last three quarters, we've been on the lower end of the range of what we've seen for the last 2.5 years. The 2.5-year range for us, at least, has been pretty tight. It has been minus 1, to minus 2, so three quarters in a row, closer to that minus 1 but that's not a refinement that I would tell you is something that you ought to set into your thinking for the market that we're operating with and the only other thing I would tell you is, it is the case with this broad portfolio that we have a lot of opportunities to position products and technologies and proven projects and technologies that, that. meet those customer demands. So that obviously helps us manage price and I'm optimistic that whatever the market environment takes us to, that we're going to be in a nice position to perform at a good level in that context that we're operating within.
Operator:
Mr. Matt Taylor from Barclays. Please go ahead with your question, sir.
Young Li:
This is actually Young Li in for Matt. I guess first on the spine business, just the LDR acquisition, is scale becoming even more important as hospitals consolidate vendors and do you now believe you have the scale to effectively compete? If not, how much bigger do you think you need to get? Thanks.
David Dvorak:
Yes, we absolutely are in a position with the LDR combination to compete effectively in the marketplace. I think that scale does matter. Scale matters as it relates to the completeness of one's product portfolio. It matters relative to your capability to build out a first-class sales force on a global basis. It matters in your ability to continuously reinvest in the business, research and development and avoid product gaps and have a nice mix of the more me-too oriented products so you don't have a hole as well as some of the things that are more aggressively going after addressing unmet needs. The Medtech acquisition would be an example of the latter, the Mobi-C products within the LDR portfolio would be a good example of the latter. So we're absolutely in a position where we're going to be able to compete effectively. I do think that it is going to become increasingly the case where, with the consolidation of customers and their desire to eliminate large numbers of vendors and consolidate themselves, that the one-stop shop provider. And not only are we going to be to do that, but spine business, we're doing that across musculoskeletal service lines as a whole. And I think that you'll see a continuing trend towards that within the marketplace and it obviously plays to our advantage.
Young Li:
Maybe a macro question just on market conditions. You mentioned it's grown at a steady pace. I heard your comments to some of the questions earlier as well but can you just maybe comment on how sustainable this trend can be?
David Dvorak:
I think very sustainable. If you bump around from one quarter to the next, like I said, there can be some billing day differences, someday mix differences but look, at the end of the day, though, population globally is aging. The need for these procedures is growing, that is unmistakable. This is in the case of large joints. The only solution for someone in advanced stage osteoarthritis in these procedures work and that underlying demand is just not going to change. You can forecast out the numbers and see how that percentage of the population that's aging and the period where there are more likely to need a total joint is going to continue to grow for years to come. So to us, that's the basis upon which we make our business decisions as opposed to bumping around from one quarter to the next with minor variations and growth rates. The dynamics are quite stable; the union or the unit demand, the pricing environment that we've been in and to the extent that there is going to be any change in the United States market, for example, the movement towards a more value-based environment for reimbursement, we're going to have the broadest of service offerings and the most cohesive capability to come in and partner more deeply with our customers to help them address their needs across that episode of care. So we like the operating environment.
Operator:
Mr. Kyle Rose from Canaccord. Please go ahead with your question, sir.
Kyle Rose:
I echo the statements on a strong Q2. Wanted to touch a little bit more on a macro perspective in the U.S.. I think about two years ago, certainly less, as Zimmer launched the be Z23, the outpatient-focused programs. I wondered if you could give us updates on not necessarily that program specifically but just as the development of the outpatient market. Where you think that could shift for the next three to five years, just from a percent of procedures moving to the outpatient. And then also saw that at CMS, in their proposed rule, is opening up commentary for potentially allowing for reimbursement of total joints in the Medicare population. So just s any thoughts on the macro overall and then what that could potentially mean if CMS does cover it moving forward?
David Dvorak:
Sure, yes, the concept of that program, as you'll recall, Kyle, is healthy patient, sick knee. So if you think about it whether it's that particular setting or the broader movement towards value-based reimbursement, these are all driven by the same trends, aging population, these providers of the solutions being pushed to do it more cost effectively than ever. And I think that our Z23 Program, Signature Solutions, are specifically designed to shape that solution and we've had good success with that program. We're ready to expand that program and do more with it and it is very integrated into our Signature Solutions offering because it is meeting the same demands that these customers are facing. So it just stands to reason that for the right patient, that the capability to get them in and out of the hospital, to avoid the potential of high-risk consequences or readmissions in the form of nosocomial infections. They can be more pervasive in an acute care setting, they got to be doing those procedures outside of the acute care setting. There are many, many patients where you're not going to be able to do that for the foreseeable future so I think that the providers understand that, that is an opportunity. It is a message that has resonated well with the surgeons. It is a small percentage today; it's going to grow. I hesitate to predict where that lands. I think that, that really needs to be driven by the way the patients present. And I think that's part of the work that needs to be done is to very carefully refine which patients are qualified for that setting and those that aren't but again, the data that we're going to be able to generate over a reasonable time period with our Signature Solutions effort is going to be part of what allows us to make those informed decisions and to continuously refine the model because it's end to end, so we will be building data in through the Z23 program, Signature Solutions and that's going to allow diagnosis and care pathway decisions to be made on a better informed basis than those decisions have ever been made in the past.
Kyle Rose:
And then just last one on just M&A thoughts, we've seen a couple of tuck-in acquisitions and then with Cayenne and the Medtech, the Rosa deal, but some bigger ones as well with LDR, just talk about your appetite for continued investments over the back half of the year and what we should expect?
David Dvorak:
We think that we've done a nice job of landing meaningful transactions to continue to execute our strategy and to us, we do that strategic planning work and identify areas where we can create value in areas of need and irrespective of whether that ends of being solved or addressed through internal or external development, that it's all part of the same program. And it just so happened that many of those efforts came together in that Q2 time period and as Q2 closed out, we moved into Q3 so I wouldn't expect that pace to be continuing into the second half of the year but we're always going to be evaluating these opportunities. We've got terrific chances to get after building out the innovation pipeline and executing on that and I think that, that is going to carry us into 2017 nicely. And as we digest those and look forward obviously, you get past a year, year-and-a-half and the cash that we're going to be generating as a business is going to put us in a great position to go on and do more, including potentially significant ones. But I think you ought to think about us as feeling good about what we have under the umbrella right now and focused on exploiting the opportunities that have come with the deals that we've done over the last couple of years largely.
Mike Marshall:
We have time for one additional question.
Operator:
Mr. Joanne Wuensch from BMO Capital Markets. Please go ahead with your question.
Joanne Wuensch:
Two questions, actually. I just want to confirm that the change in the tax accounting adds about $0.04 to the year; is that the right way to think about it?
Dan Florin:
JoAnne, this is Dan. For the first half of the year, it adds $0.03, a $0.01 in Q1 and $0.02 in Q2. We would estimate the back half to be about an incremental $0.01 so that's about right, $0.04 for the full year.
Joanne Wuensch:
And then I was really interested in your commentary regarding sales force buildout, not just in your specialized targeted sales forces but also in your large joint that you've seen increases. Can you qualitatively talk about how your sales force looks this year versus this time last year, when everybody was worried about defections and departures? Thanks.
David Dvorak:
Very stabilized foundationally, JoAnne, across the globe. And obviously we have a long period of time between signing and consummating the Biomet deal to do that planning work but then you're standing by aggressively until the deal closes and I think our commercial leaders did an outstanding job in the second half of 2015 of executing those plans. And it created some significant opportunities as we appointed leaders then to sort out the product portfolio and the customers being covered by reps to start to build greater emphasis in the non-large joint categories where appropriate and we took advantage of that opportunity. And then we started to build the pipeline of recruiting of new reps that would be able to fully exploit the opportunities, particularly outside of large joints. So that pipeline got built towards the end of last year, those positions were brought on and obviously, it takes time for those reps to become productive. So I think in Q2, you're just seeing the early signs of that productivity. It's going to continue into the second half of the year but this is going to be a dynamic that is forever for us with the critical mass scale, competitiveness of our portfolios across all product categories and our innovation pipeline and capability to make a difference with service lines, like Signature Solutions, going forward, integrating all of this. We're going to continuously build out that sales force and that's going to be a real strength for the organization going forward on a global basis. So the local leaders are going to make these decisions as to what level of specialization they need because they're closest to the opportunity and the customers and where it makes sense because it is a less populated environment for the call point is overlapping. And then we will have the same rep going after that business to the extent that the call point is more separated and it is a highly populated area. You should expect to see us with more specialization in those markets. But we've made tremendous progress in this regard in both the first and the second quarter and we'll continue to execute that plan going forward.
David Dvorak:
Thanks again, Joanne. So with that, I would like to thank everyone for joining the call today and for your continued interest and support for Zimmer. We look forward to speaking with you on our third quarter conference call. I'll turn it back over to you, Sara.
Operator:
Thank you again for participating in today's conference call. You may now disconnect.
Executives:
Robert Marshall - Vice President, Investor Relations and Treasurer David Dvorak - President and Chief Executive Officer Daniel Florin - Senior Vice President and Chief Financial Officer
Analysts:
Young Li - Barclays Bob Hopkins - Bank of America David Lewis - Morgan Stanley Joanne Wuensch - BMO Capital Markets Mike Matson - Needham & Company David Roman - Goldman Sachs Matt Miksic - UBS Raj Denhoy - Jefferies
Operator:
Good morning. I would like to turn the call over to Bob Marshall, Vice President, Investor Relations and Treasurer. Mr. Marshall, you may begin your call.
Robert Marshall:
Thank you. Good morning, and welcome to Zimmer Biomet's first quarter 2016 earnings conference call. I'm here with our CEO, David Dvorak; and our CFO, Dan Florin. Before we start, I'd like to remind you that our discussions during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements, due to a variety of risks and uncertainties. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties. During our call, we will compare revenues on a constant currency adjusted pro forma basis. This means revenues for prior-year periods have been adjusted to reflect the inclusion of Biomet revenues and the impact of the previously announced divestiture remedy. Additionally, expense ratios and related margin analysis through operating profit will be computed on the basis of adjusted pro forma financials, as revised, adjusting all periods for inventory step-up and other inventory manufacturing related charges, special items, intangible asset amortization, financing, and other expenses related to the Biomet merger and certain tax adjustments as applicable. Reconciliations of the non-GAAP financial measures discussed during our call to the most directly comparable GAAP financial measures are available on our website at investor.zimmerbiomet.com. With that, I'll now turn the call over to David.
David Dvorak:
Thanks, Bob. This morning I'll review our first quarter financial results, including key highlights from our performance. Dan will then provide additional financial details and discuss our updated guidance. We'll state all sales rates in constant currency terms and all earnings results on an adjusted basis. We're pleased to report that Zimmer Biomet's revenue was on the high-end of our first quarter expectations coming into the year, which further supports our confidence in achieving sequential improvement as we progress through 2016. Our comprehensive portfolio of musculoskeletal solutions and services provides a broad range of new opportunities for our sales channel, including a strengthened presence in a number of faster-growing product categories. Together with the increased stabilization and focused execution of our commercial teams, we remain on pace to exit the year at or above market growth rates. As we look to the future, Zimmer Biomet will continue to drive our established leadership with clinically proven devices and therapies, advanced surgical technologies and comprehensive consultative services. The strong combination of our broad portfolio, pipeline and unmatched musculoskeletal expertise allows us to play a leadership role in defining the future of healthcare through partnership opportunities with hospitals, surgeons and their patients. We'll bolster our portfolio throughout 2016 with strategic internal and external development opportunities. Our planned commercialization schedule includes over 50 new product launches this year, of which we've completed a dozen in the first quarter. These product launches included expansions to our market-leading knee and hip reconstructive systems, which I'll discuss in a moment. Our ongoing commercial introductions provide a firm foundation for sustainable revenue growth. Global musculoskeletal market conditions remain stable in the first quarter, with continued strength in United States and the Asia Pacific region. While there were ongoing challenges in certain emerging markets, these conditions were relatively consistent with recent quarters and in line with our expectations. With regard to pricing, we experienced price pressure of negative 0.9% in the quarter, consistent with our expectations. For the balance of the year, we continue to expect price pressure of approximately negative 2% when factoring in anticipated dynamics such as the bi-annual price adjustments in Japan. Against this backdrop, Zimmer Biomet delivered consolidated net sales of $1.9 billion for the first quarter, an increase of 67.8% reported and 1.2% adjusted over the prior-year period. Our first quarter performance was highlighted by ongoing sequential sales growth for our U.S. reconstructive business, which posted a 180 basis point improvement. Our overall sales in the Americas increased by 1.8% and by 3.6% in the Asia Pacific region, while our revenues decreased by 1.5% in the Europe, Middle East and Africa region. Importantly, Zimmer Biomet knee business increased sales by 3.5% in the first quarter, reflecting positive volume and mix of 4.8% and negative price of 1.3%. We accelerated our U.S. knee performance, which contributed to a 3.3% year-over-year sales increase in the Americas. We also maintained strong revenues in the Asia Pacific region, where we delivered solid growth of 7.2%. Our knee sales increased by 1.9% in the Europe, Middle East and Africa region over the prior-year period. In the quarter, our knee results were driven by our leading cross-sells, Persona, The Personalized Knee System, The Vanguard 360 Revision Knee System and the Oxford Partial Knee System. We were also excited to announce two commercial releases that expand the capabilities of our knee portfolio. Our OsseoTi Tibial Sleeves augments are a cutting-edge porous metal technology that adds to the breadth of the trusted Vanguard 360 Revision Knee System. We also introduced the Persona Medial Congruent Bearing, an innovative expansion of the Persona Knee System designed to recreate a more natural feeling knee by maximizing joint stability throughout the full range of motion. We'll continue to pursue growth with our knee portfolio, which combines market leading reconstructive systems with advanced surgical planning tools and intelligent instrumentation to offer patient and surgeons an extensive range of personalized solutions. Sales from our hip business increased by 0.5% in the first quarter, including positive volume and mix of 2.2% and negative price of 1.7%. Our hip revenues grew by 2.9% in the Asia Pacific region, increased by 1.3% in the Americas and decreased by 2.2% in the Europe, Middle East and Africa region compared to the prior-year period. In the quarter, we were pleased with the growth of our Taperloc Complete System as well as our revision portfolio and solutions that leverage our vivacity and E1 Vitamin E infused advanced bearing materials. We also expanded the G7 Acetabular System with the introduction of the G7 Dual Mobility construct and strengthened our options for the rise in adoption of the anterior supine surgical approach with the introduction of the Echo Bi-Metric Microplasty stem. These product additions along with the balance of our comprehensive hip portfolio continue to position this business for renewed growth. Turning to our SET category. Revenues increased 0.2% over the prior-year period. Strong U.S. sales of our A.T.S., Automated Tourniquet System, contributed to the growth of our surgical business in the Americas. And we were encouraged by the solid results of our surgical power tools and certain overseas geographies. The steady growth of our Extremities business, most notably in the Americas and Asia Pacific region also added to our SET revenues. Our SET results were negatively impacted in the quarter by our Trauma performance. We expect to deliver improved growth in the second half of the year with our Trauma business, supported by the increased stabilization and productivity of our commercial channel. Within Sports Medicine, we continue to be pleased with steady sales of our joint preservation treatments, Gel-One Hyaluronate and the Subchondroplasty Procedure, which was expanded in 2015 to address the growing foot and ankle market. And earlier this week, we announced that we've entered into a definitive agreement to acquire Arizona-based Cayenne Medical. This acquisition, which remains subject to customary closing conditions, will enhance our Sports Medicine capabilities and add a successful portfolio of soft tissue repair and reconstructive solutions for knee, shoulder and extremities procedures. Our dental sales decreased by 6% in the first quarter, due primarily to headwinds associated with the voluntary product action in the fourth quarter. We expect supply to fully recover by the end of the second quarter. We also continue to make good progress with the ongoing harmonization of our dental commercial channel. Backed by our broad dental portfolio, we're focused on achieving improved results in the second half of year for this business. First quarter sales from our spine, craniomaxillofacial and thoracic category decreased by 1% from the prior-year period. Our craniomaxillofacial and thoracic team delivered noteworthy growth in the quarter and they continue to generate strong sales of our TraumaOne and SternaLock Blu systems. Additionally, they made great progress with the recently launched RibFix Blu System and the OmniMax MMF System. In spine, our commercial teams continue to stabilize throughout the first quarter, which supports our confidence for an expected return of growth later this year. We also achieved sales growth for innovative offerings across our spine portfolio, including the Timberline Lateral Fusion System and the Virage OCT Spinal Fixation System. Looking to the future of this business, we're excited for the opportunities represented by our commercial pipeline and focused sales channel. With that, I'll turn it over to Dan, who will continue this discussion in greater detail as well as review our increased revenue and adjusted earnings guidance. Dan?
Daniel Florin:
Thank you, David. I will review our first quarter performance in more detail, and then provide additional information related to our second quarter and full year 2016 sales and earnings guidance. Our total revenues for the first quarter were $1,904 million, an increase of 1.2% constant currency compared to the first quarter of 2015 on an adjusted pro forma basis. The company recorded the same number of billing days in the quarter as compared to the first quarter of 2015. Net currency impact for the quarter decreased revenues by 1.6% or $30 million. The negative currency impact for the quarter was related to the ongoing relative strength of the U.S. dollar against many international currencies. Our adjusted gross profit margin was 75.7% for the quarter and 30 basis points lower when compared to the prior year adjusted pro forma result, due to the impact of foreign exchange and price decline, mostly offset by gains from our cash flow hedging program and a reduction in the expense recognition of the medical device excise tax. The company's R&D expense was 4.5% of revenue at $85.7 million. As David noted, we commercially launched a dozen new products in the first quarter and we expect to continue to that pace throughout the balance of this year, with introductions coming from across the entirety of our product categories. Adjusted selling, general and administrative expenses were $716.9 million in the first quarter or 37.7% of sales, 130 basis points lower than the comparable period in the prior year on an adjusted pro forma basis. The positive variance was driven by continued savings in SG&A expense categories, stemming from synergy capture initiatives, which were partially offset by ongoing investments in our specialized sales force, in addition to medical education and training program. We remain on track to deliver cumulative net EBIT synergies of $225 million by the end of 2016 per our original full year guidance. Synergies realized in the first quarter were in line with our expectation. In the quarter, the company recorded pre-tax charges of $393.6 million in special items, primarily related to the Biomet acquisition as well as integration-related expenses. Adjusted first quarter 2016 figures in the earnings release exclude the impact of these charges, which includes $285 million of non-cash amortization and inventory step-up charges, as well as $109 million of integration and other costs. A full reconciliation of reported net earnings to adjusted net earnings is included in this morning's press release. Adjusted operating profit in the quarter amounted to $639.1 million or 33.6% of sales, which was flat when compared to the prior-year period. Net interest expense and other non-operating expense totaled $90.7 million. Adjusted net earnings were $404.3 million for the first quarter, an increase of 51.5% compared to the prior-year period. Adjusted diluted earnings per share increased 29.9% to $2 per share on 202 million weighted average fully diluted shares outstanding. Our adjusted effective tax rate for the quarter was 26.3%. The company had approximately 200.7 million shares of common stock outstanding as of March 31, 2016, increasing from 172.8 million shares as of March 31, 2015, due primarily to the Biomet transaction. During the quarter, the company invested $415.5 million to repurchase 4.2 million shares. Our share repurchase activity during the quarter was expanded relative to our original guidance and this provided approximately $0.02 of EPS benefit in the quarter. Operating cash flow for the quarter amounted to $265.2 million, which included $85 million of cash expenditures for integration and initiatives related to our synergy program. Capital expenditures for the quarter totaled $112.7 million, which included $85.1 million for instrument and $27.6 million for property, plant and equipment. Free cash flow in the quarter was $152.5 million, which was essentially flat with the first quarter of 2015 and in line with our expectation. During the quarter, the company repaid $400 million on our term loan, leaving $2,100 million outstanding at March 31. And this reflects $900 million of repayment, since the closing of the Biomet transaction. With that, I'd like to now turn to our guidance. I will provide updated revenue and adjusted earnings per share guidance for the full year and expectations for the second quarter. For 2016, we now estimate our adjusted pro forma revenue growth to be in the range of 2.0% to 3.0% on a constant currency basis. This update is reflective of our confidence in the ongoing progress of our cross-selling initiatives and increasing sales channel productivity. Foreign exchange is now expected to decrease revenue by 1% compared to our previous estimate of 2%, with the U.S. dollar weakening modestly across most currency pair. Taken together, reported revenue growth for the year should be in a range of 1.0% to 2.0% or a range of $7,525 million to $7,600 million. For modeling purposes, we will have you update the fully diluted share count estimates to reflect the noted acceleration and timing of share repurchases embedded in our prior guidance. We now anticipate the diluted weighted average shares outstanding for the full year to be approximately 202 million shares. Therefore, after updating our assumptions for foreign exchange and our fully diluted share count, our full year adjusted diluted earnings per share is now projected to be in a range of $7.85 to $8. Our guidance takes into account our noted investment into our sales channel specialization, innovative research and development program and medical education and training to drive sustainable longer-term growth. Our guidance reflects approximately 100 basis points of forecasted operated margin expansion over the prior year on an adjusted pro forma basis. Now, turning to the second quarter. Including the benefit of slightly more than one extra billing day, which equates to about 180 basis points, we expect constant currency revenues to increase between 3.0% and 4.0%. At this time, assuming currency rates remain where they have been during the first month of this quarter, we anticipate foreign currency translation will decrease our reported second quarter revenues by approximately 1%. Taken together, reported revenue growth will be in a range of 2.0% to 3.0% for the quarter. Therefore, revenue will be expected to be in a range to $1,885 million to $1,905 million. Lastly, we expect second quarter adjusted earnings per share to be in a range between $1.93 and $1.98. Finally, please note that our full year guidance reflects the anticipated contribution from our recently announced acquisition of Cayenne Medical, assuming that the transaction closes in the second quarter, which in total represents about 10 basis points of topline growth for the full year. However, our guidance does not include any impacts from other potential business development transaction or unforeseen event. With that, I'll turn the call back over to David.
David Dvorak:
Thanks, Dan. We look forward to building on Zimmer Biomet's first quarter performance throughout the balance of 2016 as well as maintain our progress towards exiting the year at or above market growth rates. We'll continue capitalizing on the growing strength of our commercial organization and our comprehensive musculoskeletal portfolio. And lastly, we'll also remain focused on sustaining our earnings performance and driving operating margin leverage in 2016, while continuing to meet our financial commitments and exercising disciplined capital allocation. And now, I'd like to ask Cleona to begin the Q&A portion of our call.
Operator:
[Operator Instructions] We will now take our first question from Matt Taylor from Barclays.
Young Li:
This is Young Li in for Matt. I guess to start off, I was wondering if you can maybe talk about some of the initial CJR feedback or experience. Any impact since the program officially started earlier in the month? Understand that various players in the system had time to prepare for it. But is there anything surprising or notable so far that you would like to call out?
Daniel Florin:
Well, I would tell you that, Young, first of all we're excited about the opportunity that CJR provides. Going back a decade now we've been building out a comprehensive set of not only implant solutions, but services in a comprehensive nature in anticipation of a world that would be more consistent with what CJR is contemplating, that is how do we go about developing deeper partnerships with customers to bring higher quality of care in the most cost-efficient way possible. Our acquisition going back nine years ago of Accelero and the services they bring to their patient flow are focused exclusively on that area. And we've been able to bridge technologies and still more services to help develop those partnerships and build out a comprehensive care package that gets into patient engagement earlier in that episode of care, all the way through post acute care with rehabilitative services. And coming back to your question, that last area is probably where the light is going off in our customer conversation, with realizations that as much as 40% of the cost of care is incurred post acute, so the rehabilitation end of joint replacement. I would tell you that the customers are in different places right now, and their level of developing plans that are truly going to be responsive to the economic model that they're going to be living within going forward, so the early adopters and more progressive thinkers have been very sophisticated and were far long in developing key partnerships and enhancing their capabilities to be prepared for that day. Others are coming to grips with the reality that over time their world is going to shift away from fee-for-service. But in any event, we feel like we have a lot to offer with a full portfolio of solutions and services in that context. And it is the case, I do believe that as I was just referencing, that it's caused more energy on the customer part to be focused over to the post-acute care dimension of delivering the total joint solution.
Young Li:
I guess regarding the trauma weakness in the quarter that you called out, can you go into a little bit more detail as to what drove that? Is it impact from weather or any weakness in geographies you want to call out?
David Dvorak:
I don't think that this is much of a market dynamic as it is us rebuilding momentum and focus within the commercial execution side. We have a very strong portfolio. It is the case that weather and other external drivers can impact the trauma market, but I don't think that that usually measures up to be anything more than 100 basis points or 200 basis points. So we are highly confident as we continue to build out specialized sales force within that category on a global basis, that is, and continue the cross-selling training on the product side, that we're going to show material improvements in that business unit as we progress through 2016.
Operator:
Our next question comes from Bob Hopkins from Bank of America.
Bob Hopkins:
Two questions; one thing that really struck me was your guidance for revenue growth in the second quarter. You were calling for some very nice acceleration there. And I was wondering if you could just talk about some of the things that you see really driving that acceleration in the second quarter versus the first? Is that on the hip and knee side, is it across the portfolio? I assume a little bit of it's in dental. Just maybe talk about the really nice acceleration you expect in Q2?
David Dvorak:
We referenced just so you have an apples-to-apples comparison sequentially, Bob, the impact of billing days. So there is an enhancement by virtue of billing days in the second quarter, but notwithstanding that, we showed continued progression in our forecast as we displayed from Q4 to Q1 and we just believed that everything that we're doing to stabilize the sales force, to invest in the non-large joint categories, in particular, with expansion of that sales force, the cross-training, the medical training education events, all of that is building towards the progress in each of the product categories. And so I would tell you that it is very broad-based. Quite literally every geographic segment and every product category is anticipated to improve sequentially between now and the end of the year. And it's one of the reasons that we have such strong confidence in that progression is there isn't a single category that's driving it. Rather, every category is expected to prove in each quarter between now and the balance of the year. And I think that we're seeing it earlier probably in large joints and it stands to reason that that would be the case with the size of the business and those portfolios and the historic culture being ultra-focused on large joints and knees in particular. So I think knees is out ahead even within large joints of hips, but we are seeing the same signs of continued improvement in hips. And then I would tell you that the SET category is expected to show some very material improvement beginning in the second quarter and continuing into the second half of the year. It's driven by the cross-sell primarily, but we're starting to lace in, as we begun to emphasize some of the new product introductions too. And as we get into the second half of the year, we'll see some of the early signs of traction with those product launches that went out in the first quarter.
Bob Hopkins:
And then one other quickly I want to touch on is just EMEA, is there an action plan. That seemed to be one area in the large joint side that was a little weaker. So maybe is there an action plan to sort of turn that a little bit? And maybe just talk about the prospects for EMEA as you look forward the rest of the year?
Daniel Florin:
Yes. You're right. And this is one where we've seen excellent historic progress and generated great results over a long time period and so that team are the proven leaders and winners within that market. So we have all the talent that we need, and in an enhanced portfolio I think it's probably a geographic segment that has had more work to do on the integration front. And if you think about integrating within those jurisdictions, you have work councils and some external pacing items that sort of create inhibitors to getting after the cross-sell opportunity, for example. We're pushing through those consistent with our plans, and I think that what you saw in Q1, Bob, was the consistent performance, if not on large joints, a bit of sequential improvement from Q4 to Q1. And we expect to see another step in that direction and a pretty significant step up in the SET category. So we have good visibility to improve performance and that ought to stair step in Q2, Q3 and Q4 within EMEA.
Operator:
Our next question comes from David Lewis from Morgan Stanley.
David Lewis:
I wanted to start off on a financial question for Dan on earnings. I guess, Dan, a couple of things going on here. One, solid quarter, obviously better than our expectations, a little bit. You also have currency going for you, specifically with the yen. And then look, given that you're holding the line on cost and driving synergies, and you had this improving revenue outlook, it just seems to me like with that increased drop through, earnings guidance is a little on the conservative side. So can you walk me through any headwinds I could be missing? So I just feel like better quarter, better guide, better currency, the guide could have come up more. I appreciate it's early in the year, but there're factors that we're not missing that suggest that we have some earnings headwinds?
Daniel Florin:
David I wouldn't call them earnings headwinds, I call them intentional investment to drive topline growth. Smart investments focused at topline growth. So as we have indicated, for example, on the medical device tax, the suspension of that, the reinvestment of that, that's embedded in our guidance --it's still embedded in our guidance. And then as we look at the balance of the year, with respect to the currency tailwind, we do see opportunities to continue to make investment in our areas of focus such as specialized sales forces, medical education and training globally, but also importantly in the emerging market to sustain that growth. Our R&D programs, investing in personalized solutions and consultative services that add value across the continuum of care that David spoke about, enhanced instrument deployments to further drive cross-sell, and things of that nature. So as we look at the opportunity to reinvest, we're keenly focused on proper drop-through of better earnings, but also reinvesting that where it make sense to reinvest.
David Lewis:
So it's safe to assume you're feeling pretty good about your earnings and cash flow visibility right here?
Daniel Florin:
Yes.
David Lewis:
And then, David, another obviously thing that we're not expecting was this early in the year to raise your confidence in your organic numbers or constant currency numbers for the business on the top line. Our sense is there's two dynamics going on here, in the first quarter. One is, the market certainly feels a little better in reconstruction, based on some of your peers, but it also does appear on the margin you're narrowing the gap from a competitive share loss. Can you sort of talk to us about those two dynamics? How you feel about the market how you feel about narrowing your share gap?
David Dvorak:
Sure, David. Both of those dynamics are very accurate. We have seen, particularly in the U.S., a step-up in large joints. I think that the EMEA market is healthier than what we're currently experiencing as we were just responding to the prior question on that front. So the market is healthy in large joints and we know that we have big opportunities in other product categories as well. The focus on the large joint categories we have been improving our performance sequentially even above the rate of the improvement in the market growth rates, and so over a 100 basis points of GAAP closure in large joints as a whole, and that's been driven both by U.S. and o U.S. knee improvement. We see the U.S. knees improving about 70 basis points relative to market performance; o U.S. knees improving about 160 basis points relative to market. And U.S. hips as well going from Q4 to Q1 improved about 120 basis points, so those GAAP closures are really important measures, as you referenced, but it's always nice to be participating in a robust market itself. And both of those factors contribute to the visibility that we have to improve the performance and close the GAAP, and as a consequence raise our guidance for the full year to the 2% to 3%.
Operator:
Our next question comes from Joanne Wuensch from BMO Capital Markets.
Joanne Wuensch:
One of the things that we've been seeing a lot has been sort of that strength in the overall market for medical devices. And again, I apologize if you have gone into this already, is that what you're witnessing also? And if so, do you have a theory why?
Daniel Florin:
I think that the fundamental demographic drivers, Joanne, I think we are seeing healthy markets stable. There is a bit of an offset obviously as everyone else has been discussing relative to certain of the emerging market. The Latin America headwinds are still real consistent with expectations coming into the year. The Q4 and Q1 have been healthy markets in the developed countries and we certainly have benefitted from them. We look to benefit to a greater extent as the quarters progress in 2016 with our execution.
Operator:
We will now take our next question from Mike Matson from Needham & Company.
Mike Matson:
I was just wondering if you could maybe give us an update on where you stand with the efforts to develop your specialized sales forces. I know you've been focusing more on that since you completed the merger with Biomet?
Daniel Florin:
Sure. We have a good pipeline and we've made progress even in the first quarter in that regard. Mike, right now, outside of large joints on a global basis, we have round numbers 2,000 sales reps exclusively focused in the other categories. And between now and the balance of the decade, we look to expand that sales force in a material fashion and 2016 represents our first installment. So you could measure our plans in the hundreds in that regard. In 2016, we're tracking consistent with that plan. Step one was obviously the second half of 2015 to make the integration steps and stabilize those sales forces. We've rebuilt the pipeline of talent and that talent is coming to fruition, so we're in a net add position as of Q1 even, and we will look to accelerate that for the balance of the year. So I feel like we're executing those plans very well and we're already seeing some of the early signs of traction. It's part of what gives us confidence and accelerated topline growth between now and the balance of the year.
Mike Matson:
And then just in the trauma business, this seems like a market where having scale and breadth is really critical, and I was just wondering now, with Biomet products in the mix, do you feel like you've got the critical mass to really compete against the leaders DePuy and Stryker?
David Dvorak:
We absolutely are confident that we do. We have the existing portfolio to complete effectively. And you're right, scale does matter and in this category, the level ones and the level twos demand, comprehensive portfolios, and it's tough to be a niche player in that phase. And the combination greatly enhances our competitiveness within trauma. The other thing that it does is, and it's consistent across some of the other non-large joint categories for us, it puts us in a position to continue to innovate in a more diversified way and get after some of the higher risk, higher return projects to address on that needs in that category. And so rest assured that not only do we expect to execute with the current portfolio in an effective manner, but our pipeline is going to be more diverse than it's ever been and the scale gives us that opportunity. So we would look to address on that needs and push out really to establish ourselves as true innovators within the trauma space in due time.
Operator:
Our next question comes from David Roman of Goldman Sachs.
David Roman:
I wanted just to start with a comment you made in response to a prior question regarding reinvesting some of the better expected top line performance, as well as the earnings upside in Q1. Can you maybe give us a little bit more detail on where those dollars are going, whether that's on the sales and marketing side, or R&D? When you would expect us to see a return on that incremental investment?
Daniel Florin:
I responded earlier in terms of the types of investments, so there were clearly be a focus on the R&D line. So you can expect to see our spend at the R&D line to improve or to expand sequentially as we progresses through the year and that's a fairly broad base sort of investments focused on large joints, SET, programs aimed at our personalized solutions portfolio as we discussed. You'll also see in the SG&A categories some reinvestment, medical education and training, so that takes the form of training new surgeon around the world, capitalizing on the opportunity that the cross-sell investments in med ed in emerging markets, and specialized sales force, as David just mentioned adding hundreds of incremental focused sales rep particularly in the SET categories, and things of that nature. So I think you'll see it mainly in the R&D line, but also in SG&A as we progress through the year.
David Roman:
And then maybe a broader question for David. You've had three quarters since the Biomet transaction was completed, now under your belt. You have seen an improvement in your revenue growth rate. Maybe you could just help us think about what you observed over the past several quarters, and any learnings that you think will inform your go-forward investments that gets you back to that market growth rate, because clearly things are getting better, but still sitting below that 3% level. So what are you seeing in your experience thus far, and are there any changes you're making on your go-forward strategy to help accelerate the pace of getting back to market growth?
David Dvorak:
Sure, David. I think we have an opportunity, because of the pendency period that was prolonged for 14 months between signing and closing to do extensive planning. And the teams took advantage of that time and developed extraordinarily detailed integration plans to go after the topline opportunity as well as the operating expense opportunities, and it's pretty clear based upon our execution that we've been able to, if anything, retrieve and realize the operating expense synergies in an accelerated fashion as evidenced by last year's performance in that regard. I think to your question, you end up with the best visibility one can have in planning those topline opportunities and now we're in a stage where we're executing it. So we're making refinements and part of what Dan is outlining, by the way of reinvestment, would include something like the products that are going, and beyond, in theory having a cross-sell opportunity, we're realizing success. We're up in production. We're ordering more instruments. And so that's a good example of the reality. With any new product launch, and as we referred to it as sort of the mother of all product launches, you end up having some surprises both negative and positive, and where we see the positive surprises, we're going to fuel that growth. So we've got a stable channel. We're on a net basis adding sales reps in an intelligent way relative to our opportunity to make sure that our coverage is going to exploit fully the broad bag that we have, and then we're dialing it up in medical training and education and instruments and inventory where we see the growth opportunities because of early traction in the sales force. And that visibility is extraordinarily helpful. It gives us line of sight, as to sequentially between now and the end of the year, what we think we can do.
David Roman:
Can I sneak one more quick one in here? Dan, what does it all mean for the cash flow profile of the business, and if you're upping medical training, inventory, et cetera, are you still comfortable with the cash flow guidance you provided last quarter or does this still -- do some of these initiatives soak that up? And then I'll drop.
Daniel Florin:
David, we're still comfortable with the previous cash flow guidance that we provided both on an operating and free cash flow basis.
Operator:
Our next question comes from Matt Miksic from UBS.
Matt Miksic:
I hope I haven't asked a question here that's already been covered, but David, I'd love to get your sense on some of the pricing trends we're seeing in the market have been more favorable. I think at the lower end of your range, it's not the first quarter I think for you and some other folks that reported some similar trends. And I would just love to get a sense of what you think is driving that, or not to diminish less of your pricing, but is it possible that it has anything to do with your year-over-year SKU for SKU calculations with the deal? Any color would be helpful. And I have one follow-up.
Daniel Florin:
We're comfortable with the consistency of the calculation and the visibility that's provided. We had had a successful quarter in managing the business in this regard in Q4, and as you know another successful quarter in Q1 of 2016. Some of it has to do with just our forward visibility to contracts and renewals and what's in the pipeline. And so we came into the year expecting minus 2. We continue to expect something closer to that in subsequent quarters. Q2, Q3 and Q4 of 2016, and contributing to that potential uptick relative to where we were in Q1 is going to be the biannual price adjustment in Japan, which comes online here at the beginning of the second quarter, so that's sort of been quantified. It's consistent with most of the past adjustments, say, in mid-single digits based upon our product mix. So you can look at that as being the potential for round numbers, a 20 basis points uptick on a consolidated basis, but I think that we're managing the business intelligently. I mean one of the benefits of the combination is the capability with this broad portfolio to product position, and with the breadth of the portfolio and the capability to tier these products and better match the demand, the needs of customers, it puts us in a better position to maintain pricing on premium technologies, for example, across the globe, that is. And with the increased transparency on pricing across the globe, that's a big asset. So it's a good new story. The teams are taking advantage of that opportunity, but again, its two good quarters in that regard and we don't want to call it a stronger trend at this point in time. That probably does cause us to moderate a bit the negative 2% price expectation coming into the year, but we think that we're going to edge above up the 0.9 that we experienced in Q1, as we move into Q2 and beyond.
Matt Miksic:
That's helpful. I appreciate why we wouldn't necessarily want to get too excited about pricing, given where we've been, but that is encouraging. And I had one follow-up on the subject that you talked about, I think earlier in the Q&A, on bundling. Coming out of AAOS, it struck me that, yes, most of the costs that could come out of this bundled payment push, and we're early in that understanding, that is downstream after post-op and rehab, et cetera. But it also strikes me that you've talked about, I think some of your other larger orthopedic competitors have talked about stepping into the void for some of these networks, to help them understand and deal with managing those downstream costs, which are often out of the hospital or with third-party partners. And so I'd love to understand how you see that playing out in terms of sort of the value you're providing and the benefit that you would hope to get from that sort of expanded relationship in networks, as you sort of team up to get your arms around or get their arms this change?
David Dvorak:
It's a big dynamic and a big opportunity, Matt. And it's so consistent with our focus on musculoskeletal care, up and down the continuum and across the episode of care with systems, solutions and services. And this has been our strategy going back for the better part of a decade. So we really do believe, we're uniquely positioned, and these conversations and the partnership that we're entering into reflected that, the breadth of our portfolio and our commitment to developing these partnerships in a manner that adds value is going to be long-term and deep. I will tell you, every one of those conversations is validating to the work that we've done. As I said, over the last decade, I think that you can envision a day where it's very much the case that the end-to-end patient engagement is something that we're more deeply involved with. And as a consequence of the data and insight that we glean in partnership with customers that are progressive thinkers in this regard that we're mining that data, creating the right treatment algorithms, and the right clinical and economic support that announces where the unmet needs are and the opportunities for continuous improvement on both clinical and economic basis. And that's our vision. And there are a lot of customers across the globe that share that vision. And I think that, again, there are limited numbers of companies that can sit at the table with the offerings that we have to bring value to that conversation and be able to follow through and deliver. So we're excited about the opportunity and you're going to hear a lot more from us going forward on that front.
Matt Miksic:
And just if I could, so to speak -- I'm still on the line here?
David Dvorak:
You are.
Matt Miksic:
Thanks for that. The difficult part for us, I think, in looking at that engagement is the value exchange. Clearly, I think you can provide value to your larger customers in a way that a smaller player can't and a less broad provider can't. And I guess, how do we think about not to be all about share and compliance and penetration, but how does Zimmer benefit from this over the long term? Is it contracting? How should we think about it?
David Dvorak:
I think its deeper partnerships, Matt. And I think that one doesn't want to take too superficial of a view and jump to the monetization of that relationship, rather I think it needs to be about value creation. And if there is true value creation opportunity, we believe that there is true value creation opportunity through those deeper partnerships, there is going to be plenty of opportunity to sharing that upside and broader relationship up and down. Again, that continuum of care and that episode of care, and you can envision from the point of diagnosis and joint preservation through sports medicine, partial, total, revision, salvage, and the large joint, biological solutions, interventions that make sense both clinically and economically, we are convinced that there is value to be gathered for both parties and all the other stakeholders, and most importantly patients. And if we get that right, we're going to be able to figure the rest of it out. So that's the mindset that we have in entering into those relationships. A lot of flexibility and agility to get after making a difference for patients, and that's going to redound all the other stakeholders benefits. And we're sure that we'll participate that in an appropriate way.
Robert Marshall:
Cleona, we have time for one additional question.
Operator:
And our final question comes from Raj Denhoy from Jefferies.
Raj Denhoy:
Wonder if I could ask two questions. You did note the gap in joints in the market has certainly improved, which was great to see. But some of the other business, the other 40% of the business continued to lag a bit. And I know you've described your plans for getting those back up. But perhaps you could just describe whether the integration of those businesses has proven to be a bit more challenging perhaps than the large joint side? Is there anything to that or is it really just taking a bit longer?
David Dvorak:
I think it's just timing to get after the opportunity more than anything, Raj, as it relates to the SET businesses. The opportunity that we have with this combination to materially enhance the focus from a commercial standpoint is one that we're taking advantage of. And we're going to start to see in the short-term, as in Q2, some of the benefits in the SET categories. And then you jump outside of the SET categories, down we had a unique event with a field action back in Q4. As we've referenced, we were working through that challenge and Q1 will be out of that challenge by the end of Q2, and that's going to help enhanced the performance of the dental business. And then as we noted all along, the commercial integration on the spine side was known to be more challenging. And so we're going to like the result, but that one is going to take a quarter or two longer than the large joint. So we're tracking very consistently with what our integration plans contemplated, Raj. And the teams are doing an excellent job from our perspective on the execution front.
Raj Denhoy:
Just one last one, just on cash use. The cash flow over the next several years is going to be pretty significant for you guys as well as your access to cash. And in the quarter you did a small deal, but you also bought back a lot of stock. And so really just curious how you were thinking about the balance between those two efforts as well as perhaps paying down debt a bit sooner? Whether your thinking has evolved or really where it stands right now?
Daniel Florin:
Raj, I would say that our thinking on that remains as it has been, which is we continue to be interested in smart business development opportunities with a strategic focus remaining on musculoskeletal. We'll remain discipline in that regard. We'll look for targets that leverage our sales channel to drive sustainable growth and maximize shareholder value. And we'll also stay focused and show sustainable and solid returns within a reasonable time horizon. So I wouldn't think of any shift in that regard. We're still very focused on driving improvements in our free cash flow yield out overtime that will continue to be a focus, and that gives us a lot of flexibility as we progress looking at debt pay down, M&A activity, dividend payment and so on and so forth. So we will stay very disciplined as we always have been. End of Q&A
David Dvorak:
With that, I'd like to thank everyone for joining the call today and for your continued interest and support for Zimmer Biomet. We look forward to speaking with you on our second quarter conference call, which is scheduled for 8:00 AM on July 28. So I'll turn the call back to you, Cleona.
Operator:
Thank you, again, for participating in today's conference call. You may now disconnect.
Executives:
Robert Marshall - Vice President, Investor Relations and Treasurer David Dvorak - President and Chief Executive Officer Daniel Florin - Senior Vice President and Chief Financial Officer
Analysts:
David Lewis - Morgan Stanley Robert Hopkins - Bank of America Merrill Lynch Michael Weinstein - JP Morgan Chase & Co. David Roman - Goldman Sachs Larry Biegelsen - Wells Fargo Securities, LLC Joanne Wuensch - BMO Capital Markets Matthew Keeler - Credit Suisse Glenn Novarro - RBC capital markets Matt Taylor - Barclays Capital
Operator:
Good morning. I would like to turn the call to Bob Marshall, Vice President, Investor Relations and Treasurer. Mr. Marshall, you may begin your call.
Robert Marshall:
Thanks, George. Good morning and welcome to Zimmer Biomet’s fourth quarter 2015 earnings conference call. I’m here with our CEO, David Dvorak, and our CFO, Dan Florin. Before we start, I like to remind you that our discussions during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements, due to a variety of risks and uncertainties. Please refer to our SEC filings for detailed discussions of these risks and uncertainties. During our call, we will compare revenues on a constant currency adjusted pro forma billing day basis. This means revenues for prior year periods have been adjusted to reflect the inclusion of Biomet revenues and the impact of previously announced divestiture remedies, with growth rates measured on a per billing day basis. Additionally, expense ratios and related margin analysis through operating profit will be computed on the basis of adjusted pro forma financials, as revised, adjusting the all periods for inventory step-up and other inventory manufacturing related charges, certain claims, special items, intangible asset amortization, financing, and other expenses related to the Biomet merger and certain tax adjustments as applicable. Reconciliations of the non-GAAP financial measures discussed during our call to the most directly comparable GAAP financial measures are available on our website at investor.zimmerbiomet.com. In addition, we have posted to our website updated combined historical financials, as revised, along with adjusted pro forma revenue guidance. With that, I’ll turn the call over to David Dvorak.
David Dvorak:
Thanks, Bob. This morning I will review our fourth quarter and full-year financial results, as well as key highlights from our performance. Dan will then provide additional financial details and discuss our guidance for 2016. In June of 2015, we joined together two innovative companies and began executing our plans to expand our leadership position in musculoskeletal. Our combination provides significant growth opportunities with a highly complementary portfolio of product and service offerings as well as an enhanced ability to improve operating margins and drive free cash flows. The early success of our execution of these plans is reflected in our strong earnings performance. In the second half of 2015, we over-delivered against our initial net synergy targets, further validating our confidence and the effectiveness and accretive value of our combined organization. Notably, in 2015, we generated our fifth consecutive year of adjusted operating margin expansion. During the fourth quarter, we substantially completed the integration of our global commercial organizations. These actions have included the appointment of proven sales leaders and experienced sales representatives, in addition to product cross-training activities to ensure appropriate emphasis on our market-leading large joint reconstructive businesses, as well as an enhanced focus on faster growing non-large joint categories. Based upon our significant progress, we’re confident in our ability to drive sequential revenue improvement as we progress through 2016. Turning to market conditions, in the fourth quarter, global musculoskeletal markets demonstrated stability with sequential strength in the United States, offsetting a degree of softness in emerging markets and certain countries within the European, Middle East and Africa region. With respect to pricing, we experienced price pressure of negative 1.3% in the quarter. Our resulting price decline for the year of 1.9% was in line with our expectations. Moving on to our performance, Zimmer Biomet achieved stable global revenue growth in the fourth quarter with sequential improvement in the United States alongside continued solid results in the Asia-Pacific region. Consolidated net sales for the fourth quarter were $1.93 billion, an increase of 58.1% reported or an increase of 0.5% over the prior-year period adjusting for billing day differences. Importantly, our large joint reconstructive and S.E.T. categories in United States delivered 240 basis points of sequential year-over-year improvement compared to our flat sales results in the third quarter; more broadly, revenues in the Americas region increased by 0.5% in the fourth quarter. In the Asia-Pacific region, we delivered 4.0% sales growth, and our sales decreased by 1.5% in the Europe, Middle East and Africa region. Full-year sales for 2015 on an adjusted pro forma basis were $6.0 billion, an increase of 1.1% over 2014. Zimmer Biomet’s knee business grew sales by 2.2% in the fourth quarter, reflecting positive volume and mix of 4.1% and negative price of 1.9%. Our knee results were led by improved performance in the United States and an ongoing strong contribution from the Asia-Pacific region, which delivered 8.2% growth over the prior-year period. Our Americas segment increased revenues by 1.4%, and our Europe, Middle East and Africa region grew knee sales by 0.6%. Our commercial teams achieved this result with the portfolio of solutions that meet the personalized needs of each patient, while addressing surgeon and hospital preferences. Knee sales growth was driven mainly by Persona, The Personalized Knee System, a leading cross-sell opportunity, but was also supported by the strong market demand for the Vanguard 360 revision knee system, as well as the bicruciate preserving and clinically proven Oxford Partial Knee System. Sales from our hip business decreased by 0.6% in the fourth quarter; including positive volume and mix of 1.6% and negative price of 2.2%. Our Asia-Pacific region revenues increased by 0.7% and hip sales decreased by 0.8% in the Americas as a positive performance in the United States was offset by Latin America results. Our Europe, Middle East and Africa sales decreased by 1.0% from the prior-year period. In future quarters, we will continue to pursue growth with our broad hip portfolio, including our G7 Acetabular System, Taperloc Complete Microplasty stems and the Arcos Femoral Revision System. Turning to our SET product category, sales in the fourth quarter increased 1.6% over the prior year period. We achieved solid results with our Sports Medicine, Surgical and Extremities portfolios, which were offset somewhat by our Trauma sales performance. The ongoing growth of our sports medicine offerings is highlighted by our Gel-One Cross-linked Hyaluronate and Subchondroplasty treatments. In Surgical, our sales were supported by the performance of our Transposal Fluid Waste Management System and A.T.S. Automatic Tourniquet System, which continue to expand our presence in the operating room suite. Within Extremities, we’re addressing a broad range of clinical situations and surgeon preferences as evidenced by the commercial success of our comprehensive Total Shoulder System and the Nexel Total Elbow. In future quarters, we’ll leverage our specialized sales-force and robust Trauma portfolio for improved results, with innovative solutions such as the DVR Crosslock Distal Radius Plating System, the AFFIXUS Hip Fracture Nail System and the Natural Nail System. Worldwide dental sales decreased by 6.7% in the fourth quarter. Our dental category experience revenue headwinds due to a supply disruption related to a voluntary field action in response to a packaging issue. We are in the process of remediating this matter and we expect to do so fully by the close of the first quarter, which will help position us to reestablish our momentum in dental in the second-half of the year. We remain encouraged by the early success of our cross-selling activity, particularly with our market-leading regenerative product line as we progress through the integration of this business. Zimmer Biomet spine, craniomaxillofacial and thoracic category revenues decreased by 2.0% from the prior year period. Our craniomaxillofacial and thoracic team continue to deliver strong growth, driven by steady demand for our TraumaOne and SternaLock Blu Systems as well as growing acceptance of our RibFix Blu System. With regard to spine, we successfully completed the integration of our U.S. spine commercial channel with anticipated near-term revenue dyssynergies slowing our growth in the quarter. We believe this business is well-positioned for accelerated performance in 2016, with a more comprehensive portfolio of innovative spinal solutions including the Virage OCT Spinal Fixation System, the Polaris Spinal System and the Timberline Lateral Fusion System. With that, I’ll turn it over to Dan, who will continue this discussion in greater detail, as well as review our guidance. Dan?
Daniel Florin:
Thank you, David. I will review our fourth quarter performance in more detail, and then provide additional information related to our first quarter and full-year 2016 sales and earnings guidance. Our total revenues for the fourth were $1.934 billion, an increase of 0.5% constant currency compared to the fourth quarter of 2014 on an adjusted pro forma billing day basis. Net currency impact for the quarter decreased revenues by 4.4% or $90 million. The negative currency impact for the quarter was related to the ongoing strength of the U.S. dollar against many international currencies. As David reviewed, we were encouraged to have substantially completed the integration of our commercial teams, which contributed to the sequential improvement of our reconstructive and S.E.T. performances in the United States, which increased over a flat year-on-year growth rate in the third quarter to 2.4% this quarter, in line with our expectations. However, we did have some unanticipated headwinds, including decelerating market condition in certain emerging and southern European countries, as well as the dental field action which David referenced. These conditions led to our overall constant currency sales growth coming in at the bottom of our guidance range. Our adjusted gross profit margin was 75.6% for the quarter and 20 basis points less when compared to the prior-year adjusted pro forma results due to the impact of foreign exchange and price declines mostly offset by gains from our cash flow hedging program. The company’s R&D expense was 4.4% of revenue at $85.9 million and 20 basis points higher when compared to the prior-year period. Adjusted selling, general and administrative expenses were $723.6 million in the fourth quarter or 37.4% of sales, an improvement of 170 basis points over the comparable period in the prior year. We continue to achieve process and operational efficiencies in the fourth quarter through the ongoing implementation of initiatives designed to capture synergies. In the quarter, the company recorded pretax charges of approximately $533 million in special items, primarily related to the Biomet acquisition and integration related expenses. Adjusted fourth quarter 2015 figures in the earnings release exclude the impact of these charges, which include $380 million of non-cash amortization and inventory step-up charges as well as $120 million of integration costs. A full reconciliation of reported net earnings to adjusted net earnings is included in this morning’s press release. Adjusted operating profit in the quarter amounted to $652.4 million or 33.7% of sales, a 120 basis point improvement over the prior-year period. Net interest expense for the quarter amounted to $88 million, consistent with expectations. Adjusted net earnings were $428.3 million for the fourth quarter, an increase of 39.2% compared to the prior year period. Adjusted diluted earnings per share increased 17.4% to $2.09 on 205.2 million average outstanding diluted shares. These adjusted earnings per share are inclusive of approximately $0.03 of share-based compensation. Adjusted diluted earnings per share for the year increased 7.8% to $6.90 on 189.8 million shares. Our adjusted effective tax rate for the quarter was 23.8%. The company had approximately 202.6 million shares of common stock outstanding as of December 31, 2015, increasing from 169.7 million as of December 31, 2014 due primarily to the Biomet transaction. During the quarter, the company invested $150 million to repurchase 1.4 million shares. As of December 31, 2015 approximately $450 million remained available under the existing share repurchase authorization. Operating cash flow for the quarter amounted to $433.2 million, an increase of 22% over the fourth quarter of 2014. This result includes $114 million of cash expenditures for integration and initiatives related to our synergy program. Free cash flow in the fourth quarter was $303.7 million, which was 12% higher than the fourth quarter of 2014. Capital expenditures for the quarter totaled $129.5 million, which included $80.4 million for instruments and $49.1 million for property, plant and equipment. During the quarter, the company repaid $350 million on our term loan bringing the repayment total in 2015 to $500 million. Our gross leverage ratio at December 31 was 4.0 times. I’d like to now turn to our guidance. I will provide revenue and adjusted earnings per share guidance for both the first quarter and the full-year. Additionally, I will review our expectations for free cash flow in 2016. Beginning with our market assumptions for 2016, we believe that the musculoskeletal markets in which we participate will grow approximately 3%. We expect global market conditions to remain stable in 2016, when compared to the full-year 2015. Price is forecasted to be approximately negative 2% consistent with the last several years. For 2016, we estimate our adjusted pro forma revenue growth to be in a range of 1.5% to 2.5% on a constant currency basis. Foreign exchange is expected to decrease revenues by 2.0% primarily driven by the euro and Australian dollar along with certain emerging market currencies. Taken together, revenue growth for the year should be in a range of negative 0.5% to positive 0.5% or a range of $7.415 billion to $7.490 billion. As David outlined, with the integration of our commercial organization substantially complete, we expect constant currency year-over-year revenue growth to improve sequentially as we progress through 2016. In terms of quarterly revenue phasing, we expect first quarter constant currency growth of 0.5% to 1%. And I would guide you toward market growth rates, as we progress through the second-half of 2016. We will drive revenue acceleration across multiple product categories with offerings such as Persona, The Personalized Knee System; The Oxford Partial Knee; Gel-One Cross-linked Hyaluronate; Knee Creations Subchondroplasty; and the Arcos Modular Femoral Hip Revision System; additionally supported by a cadence of new product launches. We expect to realize increasing sales-force productivity over the course of the year, driven by added stability and specialization in our global sales organizations, and supported by the benefits of our medical education and training programs. As you move down the income statement for 2016, assuming currency rates remain near recent levels, we expect our gross margin ratio to be between 75.5% and 76%. This takes into account anticipated gains on foreign currency hedges, principally from the euro and Japanese yen. I would like to note that the company won’t realize the full annual P&L benefit from the suspended medical device excise tax in 2016, because it was largely treated as an inventoriable cost. The portion that provides relief to the P&L during the year amounts to approximately $20 million and we intend to reinvest this benefit in R&D to accelerate our innovation and growth opportunities. We expect R&D expense for the year to be in the range of 4.5% to 5.0% of sales. SG&A is expected to be approximately 37% of sales as we continue to realize efficiencies from our synergy initiative and further leverage revenue growth. Assuming interest rates remain near recent levels, we expect net interest and other expense of $365 million. This incorporates our debt repayment plan throughout 2016. We anticipate and adjusted effective tax rate to be approximately 26%, which is in line with our final full-year rate for 2015. We anticipate the diluted weighted average shares outstanding for the first quarter to total approximately 204 million shares and in a range of 203 million to 204 million shares for the full year. This share count considers additional share repurchases plan during 2016; therefore, full-year adjusted diluted earnings per share is projected to be in a range of $7.80 to $7.95. Given our early success in capturing cost savings, we remain on pace to deliver our net operating EBIT synergy target of $350 million by the end of year-three with approximately $225 million of cumulative net benefit achieved by year-end 2016. As I stated earlier, we expect revenues to increase between 0.5% and 1.0% on a constant currency adjusted pro forma basis when compared to the first quarter of 2015. At this time, assuming currency rates remain where they have been during the first month of this quarter, we anticipate foreign currency translation will decrease our reported first-quarter revenues by an estimated 2.5%. Therefore, we expect first-quarter revenues to be between 1.5% and 2.0% below the prior-year period, or a range of $1.870 billion to $1.880 billion. We expect gross margin and operating expense ratios to be similar during the first quarter, as those realized in the fourth quarter of 2015. Our adjusted effective tax rate is expected to be between 26.5% and 27%. Therefore, we expect first-quarter adjusted earnings per share to be in a range between $1.90 and $1.95. Turning to cash flow, we anticipate full-year 2016 operating cash flows to be in a range of $1.65 billion to $1.75 billion, inclusive of approximately $290 million of expenditures in support of our synergy program. This compares to full year 2015 of $863 million. This includes total capital expenditures for the year, which are expected to be in a range of $550 million to $575 million. Instrument capital is expected to be in a range of $300 million to $325 million in support of our cross-sell initiative, as well as new product introductions. Traditional PP&E is expected to be approximately $250 million, including $105 million necessary to rationalize facilities and ERP systems, as well as optimize our manufacturing and logistics network. Free cash flow is therefore expected to be in a range of $1.075 billion to $1.020 billion for the year. Our guidance assumes that we will continue to delever our balance sheet with planned debt repayments of approximately $1 billion. Exiting the year with a leverage ratio of approximately 3.5 times on a gross basis or just under 3.0 times on a net basis. We intend to return excess cash to our stockholders through our share repurchase and dividend programs. Free cash flow in excess of these capital allocation programs is assumed to be held in cash and cash equivalents or other investments. For modeling purposes, intangible amortization expense for the year is estimated to total approximately $600 million. And finally, please note that our guidance does not include any impact from other potential business development transactions or unforeseen events. David, I’ll turn the call back over to you.
David Dvorak:
Thanks, Dan. As we approach the opportunities of the year ahead, the substantial completion of our commercial integration combined with our broad and highly complementary portfolio, positions our business for accelerated top-line growth. In addition, we have supplemented our product offerings with an enhanced R&D investment that is 60% greater than existed within either stand-alone company. During 2016, we expect to release the cadence of differentiated products, technologies and services across the entirety of our musculoskeletal portfolio. Taken together with our demonstrated approach to discipline capital allocation, we’re committed to accelerating revenues and sustaining operating margin and earnings-per-share growth through the balance of the decade. And now, I’d like to ask George to begin the Q&A portion of our call.
Operator:
Thank you, sir. Ladies and gentlemen, we will now take your questions. [Operator Instructions] Our first question is from David Lewis with Morgan Stanley. Please go ahead.
David Lewis:
Good morning.
David Dvorak:
Good morning.
David Lewis:
So just two questions, I’ll start with Dan and then one for David. So, Dan, I think the one thing about guidance that stands out to us, obviously is the EPS guide looks strong, obviously confidence at the high-end of the range, rather materially above the Street. So can you drill down on this, this early in 2016, obviously, what are the factors that give you the confidence in that earnings visibility in 2016? And then a quick follow-up for David.
Daniel Florin:
Sure, David. What gives us confidence is really the integration and synergy program and the progress that we continue to make and the clear line of sight that we have to the synergy opportunity as we progress through 2016. If you recall, at the time of the merger announcement, we announced $135 million of net EBIT synergies in year one. And then, during the Q3 call, we raised that to $155 million and stayed with the $350 million by year three. As we look at 2016, we see $225 million of cumulative net EBIT synergies in the P&L and we have good line of sight to that. So that’s what gives us strong conviction and the ability to deliver on that synergy, along with the ability to see sequential improvement on the top line and the flexibility we have with our capital allocation.
David Lewis:
Okay. Thanks, Dan. And, David, I think investors are getting more confident earnings, but obviously to move the multiple the organic growth has to go higher. I think from our math the picture of the fourth quarter were sort of one still of stability. And so how do you move from stability in the fourth quarter to sort of improvement in the - throughout 2016 and sort of what provides you the confidence that we’re going to get that that steady organic progression here? Thank you.
David Dvorak:
Right. David, I think it is appropriate to characterize the fourth quarter performance as you did. And yet, I would tell you that the progress that we made on the commercial channel integration was very, very significant. Probably the most important element of the integration as a whole, as Dan said, we - and you referenced, we have a high degree of confidence in our ability to deliver on the operating synergies. But with the progress that we made in the fourth quarter to a point sales leaders across the globe, intermediary management level and clarify the roles of reps in all product categories, through compensation plans, the bags that they are going to be carrying, the territories that they’re going to be selling to, targets for them for 2016. All of that clarity and visibility along with a really aggressive effort to get people trained up on products that - six months ago they weren’t at all familiar with, because they didn’t have in their bag. That sets us up to make the progress that we’re referencing in 2016. So - and then we’re already seeing the beginnings of the cross-sell coming to fruition, as well we had some very successful kickoff meetings with further product training education, and I would tell you that the attendance, from a surgeon-perspective, our medical training education program show a big acceptance and interest in learning about the new products, technologies to ensure their safe and efficacious use, so all of that gives us visibility that we’re going to push out sequential improvement each quarter of 2016. And stands to reason relative to what we were a year ago that that would be the case with the certainty that comes with the progress I just described to you. Furthermore, the revenue dysynergies will begin to anniversary out as we get into the latter part of the year and so you can picture a line graph where the cross-sell is accelerating through the year. And the revenue dysynergies as you get to the back part of the year begin to anniversary out. And as a consequence we’d expect to hit market growth rates in the second half of the year, and then exit the year at or above market growth rates.
David Lewis:
Okay. Thank you very much, David.
David Dvorak:
You’re welcome.
Operator:
Thank you. And our next question comes from Bob Hopkins with Bank of America Merrill Lynch. Please go ahead.
Robert Hopkins:
Thank you and good morning.
David Dvorak:
Good morning.
Daniel Florin:
Good morning.
Robert Hopkins:
So just to really to follow-up on that, because you definitely agree that there is really nice progress being made here with cash flow and earnings. So I just want to drill down a little bit more on the prospects for revenue growth improvement, so a couple of quick things. First, it sounds like this is the case, but can you just confirm, David, that the level of sales-force turnover that you’re seeing is kind of as you expected, I just would love to get a specific update there? And then, also in your 2016 revenue growth guidance, are you assuming that Southern Europe and emerging markets improve or are you assuming they kind of stay the same? And then, lastly and probably most importantly, I was wondering if you could just kind of drill down a little more specifically on, what are the product lines that you think are most likely to drive acceleration over the course of 2016? What are the things that you have the most confidence in? Thank you.
David Dvorak:
Sure, Bob. I think that to take them in order, the sales-force turnover is very consistent with our expectations. We had described to you that with a fairly normal cadence of turnover in 2015. But what had transpired in the first-half of the year was a slowing of the hiring, particularly in the case of the independent distributorships. That began to correct out as the months progressed. And now we’re entering 2016 with an expectation that that will net one another out and we’ll get into positive growth. In particular, emphasis is going to be placed upon the non-large joint to bring more sales-force specialization, because we have all the necessary ingredients from the product portfolio to compete very effectively in some of those faster growing markets. And a lot of room for growth and runway based upon our market share. So we’re enthusiastic about that. So consider the sales force to be stable and we would look 2016 to bring net gains and sales force representation. The presumption on the emerging markets and sort of the certain countries within Europe that we referenced in our comments is at steady state, probably more of what we would expect to see or what we experienced in the second half of 2015 continuing into 2016. And there’s been a lot of discussion around, Latin America in particular we’ve experienced that in full. In our case, our business in China is held up more strongly than what it sounds like other people are commenting on. And we continue to believe that will perform strongly. But even that business has slowed down. We’re still in a growth mode in China. So those emerging markets have gone from historically strong mid- to upper-teen growth quarter-to-quarter, to sort of double-digit growth by the middle of last year into low single-digit growth. And we’d expect that picture to improve, because we’re going to be anniversarying out of some of those downward trends, so more than that dictates that. As far as the products go, it’s a long list, but I could rattle off the top of my head some of the ones that we’re already seeing, a lot of interest and uptake on Persona, is it’s doing really well, obviously taking that product into the legacy Biomet customer accounts. I would tell you that within the knee category, we’re seeing a lot of interest in Oxford at this point in time. And that’s an opportunity for us. In light of the divestiture that’s pretty special. We are doing very well with Gel-One. We’re doing very well with Subchondroplasty. We’ve talked to you in the past about the hip products that are additive, mostly coming from the legacy Biomet side that had been performing quite well. And that’s a business unit that we need to shore up that concludes revision on the side of the hips. The comprehensive shoulder is doing very well on the Extremities side. And I would add in some of the complementary aspects of the product portfolio within Trauma. Distal Radius Plating, which was a space that legacy Zimmer was not hardly present at all-in. We’re going to do very well with that product. That’s a pretty good list for you.
Robert Hopkins:
Yes. I appreciate the detail. I’ll leave it at that. Thanks very much for the help.
David Dvorak:
You bet. Thanks, Bob.
Operator:
Thank you. And our next question is from Mike Weinstein with JP Morgan. Please go ahead.
Michael Weinstein:
Good morning, guys. Thanks.
David Dvorak:
Good morning, Mike.
Michael Weinstein:
So my first question is pricing got better in the fourth quarter. Your pricing was down 1.3% versus 1.9% for the year. And then, you guided to down 2% for 2016. So was there something in the fourth quarter that was an anomaly on the pricing front, or is there a reason to think that pricing will do better than what you’re guiding to? Thanks.
Daniel Florin:
Sure, Mike. You’re right. We had experienced the last two years of very tight range within tens of basis points right around that two-number consistently. So the year actually ended on a positive note. And when you pull it altogether, minus 1.9% for the year is on the low-end, really at what we had guided to coming into the year. It was a good quarter. I think that the teams are doing a nice job in particular of positioning these products. The broader portfolio creates opportunities to ensure they were matching the customer need, customer ability. And I think that this is going to be a sustained feature of the broader portfolio that comes with the combination. That said, one quarter - a trend does not make. And we just want to be smart about our guiding going forward. I think that the 2% number is the right way to think about price down in 2016. And remember that, although we’re anniversarying out of - at the end of Q1, the biannual adjustment, which got spread off over two years in Japan, we’ll re-enter that world come April 1, with the next round. So all of that in, I think that that approximate 2% down is the right way to think about 2016, Mike.
Michael Weinstein:
Okay. And then just two clarifications; so one, David, you talked about part of the math on growth acceleration in the back-half as you’ll have easier comps. You said that the attrition on your reps was normal. So what is it that you see as being easier in the back-half of the year relative to the first-half in terms of was there in the back-half of the year was your lost business that you’ll anniversary on or lost territory managers that you anniversary on? And then, just to clarify your view of market growth and getting to market growth in the back-half of the year, is that 2.5% to 3%? Is that better than that, would love to nail you down on that? Thanks.
Daniel Florin:
Sure, Mike. I think about that market growth rate in round numbers of 3%. And the sequential improvement really isn’t driven by anything in particular by way of anniversarying, I guess, out of a loss in a particular area, as much as it is just running the offense that we have at this point in time. I mean, it’s true that the math is advantageous to produce growth rates based upon the performance of the company in the second-half of last year. And you’re able to have full access to those numbers to understand that dynamic, but we’re focused on taking what we believe to be the industry-leading product portfolio and executing. And remember that as we built this channel out across the globe, we picked the most successful leaders. In the U.S. we’ve referenced this before; on average those selected leaders were growing their business at 300 basis points above those that were not selected to take the business forward. So we have a lot of experience at the rep level, proven leadership at the territory level and with this product bag and running the offense that we expect to run, we’re just going to be driving ourselves back into that market growth rate. So think of that that second-half as 3% and then, of course, with the presumption that we’re communicating that every quarter we’re going to improve that we ought to be exiting the year at or above that 3% rate going into 2017.
Michael Weinstein:
Okay. Perfect. Thank you, guys.
David Dvorak:
Thank you.
Operator:
Thank you. And our next question is from David Roman with Goldman Sachs. Please go ahead.
David Roman:
Thank you and good morning, everybody. I want to just to start on the pipeline side of the story. And one of the elements clearly that was sort of sitting under the hood at Biomet is just the degree to which I think at the time of the acquisition they were on pace to develop a fairly decent cadence of new products. So maybe you could sort of talk to us about where you are with respect to integrating the pipeline products like the Biomet XP Knee and maybe some of the products in the Sports Medicine side, and when we can sort of get an update on how those rollouts are progressing.
David Dvorak:
We have a couple of dozen products that we expect to launch this year David and just as the visibility to the existing product portfolio has become clear as we’ve been able to get around and talk to various stakeholders, I would tell you that the pipeline is just as impressive by virtue of the combination. And so, the thing I would tell you is that as we move those products into full commercial release, we’ll be communicating those, we’ll update you in the conference calls, we’ll be putting our press releases to highlight those product and solution releases. And we’d look to do a bit of a preview at the academy this year too. We just want to be smart about the pace of communicating that. But it is the case that it is across all product categories. It’s an impressive pipeline and that really isn’t the basis for the sequential growth. That plan is really built more fundamentally off of the existing bag. But I would tell you that we think that this product pipeline is going to set us up well, as we get back to market and beyond growth rates to sustain that performance going forward.
David Roman:
Okay. So I’d just ask a follow-up on that and then combine it with a financial question. So is it the right way to think about it, David, and that the execution around the sales-force and the integration what drives you back to market growth and the pipeline that you just referenced, and on which we’ll get more detail, is what drives you towards that 4% plus that you presented in January, is it 2020 goal? And then, on the financial side, Dan, it looks like from your guidance that your conversion from net income to operating - adjusted income to operating cash flow is roughly a 100% which is obviously a pretty good number. Is that the right type of ratio to think about on a go-forward basis?
David Dvorak:
So, David, I’ll respond to the first part. I would - maybe a subtle adjustment to the way you framed the response. I would tell you that the existing product portfolio puts us in a position to get back to market growth and then above market growth rate. And I see the pipeline is sustaining that above market performance thereafter.
Daniel Florin:
David, with respect to operating cash flow in relationship to adjusted net earnings, certainly, 2015 and to a lesser extent 2016, cash flow has been weighted down by integration related cost as well as the merger cost themselves. So I think that you will absolutely see us kind of return to a normalcy in correlation between adjusted net earnings and our operating cash flows. So that’s the right way to think about it.
David Roman:
Okay. Thank you very much.
Daniel Florin:
Thank you.
Operator:
Thank you. And our next question is from Larry Biegelsen with Wells Fargo Securities. Please go ahead.
Larry Biegelsen:
Good morning. Thanks for taking the questions.
David Dvorak:
Good morning.
Larry Biegelsen:
First, obviously, you showed a stability in Q4, but there is a narrative out there that the disruptions might manifest few quarters after the deal-close, as contracts start expiring that you signed as part of a retention program. So, David, can you lay people’s concerns that maybe that will come to fruition? And I had a follow-up, thanks.
David Dvorak:
Sure, Larry. There really aren’t any such contracts. I think that to the extent that there were any kind of state plan that was more in the Biomet side, and those would have been geared towards retention through closing. So we’ve already transitioned the business. We’re running as one entity. And I would tell you further more that to the extent the third-party arrangements that we’re into as part of the distribution channel, with those we’ve had great success in solidifying those contracts, getting those things executed and those include any compensation plan that we carry forward. So that is seamless from 2015 and 2016. And we don’t see risk along the lines of what you’re questioning.
Larry Biegelsen:
That’s helpful. And then for my second question, maybe it would be helpful to hear your updated thoughts, David, on robotics. Obviously, one of your competitors seems to be getting a little more traction there, as well as custom implants. And at Biomet, I believe, you talked publicly about having custom implants before the acquisition. So an update on that program and how much of a priority that is for you? Thanks for taking the questions.
David Dvorak:
Sure, Larry. I think that the opportunity to drive enhanced quality in a cost efficient way is an area of focus for us from an innovation standpoint. It’s been an area of focus for us through both internal and external development over the better part of the last decade. And we’re happy with our progress. The portfolio of preoperative and intraoperative technologies that we’ve assembled and continue to expand is strong. It includes proprietary technologies like iASSIST as well as Signature PSI eLIBRA for soft-tissue balancing. And we think that there is a wonderful value proposition for that set of technologies. But we’re mindful in a way that we’re developing these technologies to ensure that there is in fact a proven clinical benefit and it’s delivered in a cost efficient way. And in the evolving healthcare market that we’re looking to serve and the partnerships that we want to create, that it will be deeper than ever with these customers, to ensure that they’re bringing about an enhanced level of quality in the patient care, that they deliver at the same time, that they’re managing costs in an optimized way. We think that that’s the right recipe. So we think that there is a need and an opportunity to improve. We think that, for instance on the large joint side, to drive towards more reproducible use of these systems; the alignment, placement soft-tissue balancing; all areas that we’re very much focused on, we just think that it needs to take the form of clinical proven cost-efficient solutions. And so that’s what we’ve been focused on and what we’ll continue to focus on. We’re really agnostic as to the embodiment of that technology, so long as it meets those needs. With respect to - you referenced custom solutions; we have built out a wonderful portfolio of personalized solutions. Our interventions we can help clinicians irrespective of where that patient is in the disease state along the continuum of care. And then, wherever that plot point is on the continuum of care for that particular patient, we want to offer the most personalized solution. So when you apply that to our portfolio, everything from early intervention, joint preservation solution, such as Gel-One and Subchondroplasty through partial knee replacements, for instance, with Oxford into a total knee solution whether it’s Vanguard or Persona, The Personalized Knee System. That’s a system that offers approximately 17,000 permutations. So we did extensive work to identify anatomical differences and designed a system that would address any of those anatomical differences with clinical significance. And so, there really is a mass customization strategy that’s worked very well to leverage off of the heritage and clinical proof points of the legacy systems and ensure that we’re bringing about improved patient outcomes without incurring the risk of going backwards. We referenced Biomet’s custom solutions. It is the case that the Vanguard Select is a custom solution. So as I described to you, the mass customization approach that we took with Persona, there are going to be instances where a patient’s anatomy is such an outlier or in oncology context, bone void context, deformities, you need a true custom solution. And I’m sure that our company has done more of that in the musculoskeletal space than anyone, including the solutions that Biomet has provided. And that isn’t just in large joints. We do terrific work. I was just down a week ago in our craniomaxillofacial group. And they’ve done some, quite literally, life-saving solutions for patients on a true custom basis. So across all of our product lines, we have active efforts and existing solutions in that regard.
Larry Biegelsen:
Thanks for taking the questions guys.
David Dvorak:
You bet, Larry.
Operator:
Thank you. And our next question comes from Joanne Wuensch with BMO Capital Markets. Please go ahead.
Joanne Wuensch:
Good morning. And thank you for taking the question. Spine was lagging this particular quarter or getting a lot of different results out of different manufacturers. And I was curious, if you could provide a little bit of color on what you’re seeing. But more - what does it take for you to get that back more towards a market growth rate?
David Dvorak:
Sure, Joanne. I think that that’s one where as we indicated going back a quarter, the expectation was we were going to see some revenue dyssynergies by virtue of the integration. We’ve completed that integration. All of the independent distributors are signed up at this point. United States is a strong channel and the product portfolio is stronger than either entity had quite obviously. So whether it’s MIS with the legacy Zimmer PathFinder system or lateral access approach with Timberline and the implant technologies, and we’ve got some exciting launches to come yet in 2016 on that front; so that a sales-force that’s ready to go. I don’t think that we’re going to be talking about that hitting back to market growth for very long before we’re past that point. We’re taking share. I expect that to happen in 2016.
Joanne Wuensch:
All right. That’s helpful. And then, this is a boring question, so forgive me. Tax rate, is there a way that this could be managed? Thank you.
David Dvorak:
We give, Dan, all the boring questions.
Daniel Florin:
Thanks, Joanne.
Joanne Wuensch:
Any time.
Daniel Florin:
It’s actually a very important issue for us, and one that we are very focused on - over the past year we’ve been focused on establishing a way to repatriate cash from offshore to the U.S. in a tax efficient manner. And we did that through structuring alongside the merger transaction. So that was really a critical near-term priority that’s complete at this point. And as we come in here to 2016, coordinating efforts with our head of manufacturing and supply chain, we see a path towards a lower future adjusted effective tax rate. It takes some time to put the building blocks in place to accomplish that. But we’re very focused on it, and expect to see improvements in the years to come. Not in 2016, but beyond that we see a path towards a lower effective tax rate.
Joanne Wuensch:
Terrific. Thank you.
Daniel Florin:
You’re welcome.
Operator:
Thank you. And our next question comes from Matt Keeler with Credit Suisse. Please go ahead.
Matthew Keeler:
Hey, guys. Thanks for taking the questions. I guess, just to start on - you highlighted strong growth in Asia and mentioned that China had been a point of strength relative to some of your competitors. What do you attribute that, is it sort of different business mix or do you think you’re actually taking share there?
David Dvorak:
Well, we’ve had strong performance for a long, long time in that market. So I would expect, we continue to perform well relative to the market, Matt. But I think it’s also fair to point out that the mix of the business is likely different. Some of the companies that are reporting out have business segments and sectors that we don’t operate within, that it sounds like might be more materially impacted by what’s happening in a macro economic sense within that marketplace particular. For instance, the capital goods side is not that prominent for our businesses. It’s more of a traditional orthopedic business that we’re focused within the Chinese marketplace. So I would expect that business for us to continue to perform well, but as I said, it did slowdown relative to its historic growth rates.
Matthew Keeler:
Got it, thanks. And just my follow-up, your Americas growth in knee has got a little better. I think in hips it was relatively consistent with last quarter. Just any color you can provide on how you see that market and can you give us any context around the impact of LatAm on Americas’ hips and knees in the quarter?
David Dvorak:
Yes. It was fairly substantial within the quarter. Now, we’re seeing the fact that that scheme of things, it’s not a large business, just because the downturn has been pretty dramatic in Latin America. As you said, within the United States market, we took a sequential step forward just in growth rates in both the large joint categories, but closed the gap to a greater extent in knees. And, Dan, you may be able to provide a little bit more clarity on the Latin America breakout.
Daniel Florin:
Well, I think that as David said in the U.S. on these good progress, closed the gap to market, not at market growth rates based on our model for the fourth quarter. But importantly, began to close that gap. Some work to do on hips. But as we talked about on the pipeline side and the cross-sell opportunity, we see a path towards closing that gap to market first-half of the year, and then, working our way back above market. The Latin America piece, as David said, is not that significant. But the declines are significant in a place like Brazil, which is enough to create a headwind at the Americas level. And then, quite frankly at the consolidated level as well. And back to the earlier question, our guidance for 2016 on Latin America assumes a very similar environment in 2016 as we’ve seen here in 2015.
Matthew Keeler:
Okay. Thanks.
Daniel Florin:
You’re welcome.
Operator:
Thank you. And our next question is from Glenn Novarro with RBC capital markets. Please go ahead.
Glenn Novarro:
Hi, good morning, guys.
David Dvorak:
Good morning.
Glenn Novarro:
Your EPS guide for 2016 came in well ahead of our expectations. And if I look at the two biggest changes within the P&L, at least relative to our thinking, it’s in the gross margin as well as in the SG&A ratio. So, Dan, I’m wondering if you can provide us a bridge as to what’s getting us to the higher gross margins for 2016, and as well as a bridge to what’s getting us to a lower SG&A ratio. Any specifics would be helpful. Thanks.
Daniel Florin:
Sure. With respect to the gross margin rate, our assumption is that 2016 actually is quite similar to 2015. And now there’s a lot of moving parts within that ability to hold the gross margin rate. There is the impact of foreign currency through the translation, but then there is also the benefit of the cash flow hedges that flow through the gross margin line as well. On top of that, the synergy program, we do start to begin to see some level of benefit at the COGS line by virtue of the integration. And that’s also contributing to kind of a flattish overall gross margin. And I think the other important point while, foreign currency, the impact to the 2016 P&L remains significant as that was in 2015. And so the foreign currency headwind, their earnings is in the neighborhood of $0.15 or $0.16 of headwind on EPS. The other important point, as we are planning to reinvest the medical device tax. And so we account for that up in COGS. So there is the shift out of COGS into R&D in our 2016 guidance.
Glenn Novarro:
And then, just can you comment a little bit on SG&A, because at least relative to our model, the SG&A ratio is coming in below what we were forecasting; so any specifics there that you can call out? I know that you said on the call that the cost savings are right on track. But at least to us it seems like maybe cost savings are coming a little bit quicker. Thanks.
Daniel Florin:
You’re right. The SG&A progress is predominantly related to the integration and the synergy program. So I quoted accumulative $225 million in 2016. And that’s really focused bit in COGS and more proportionally in the SG&A area. That’s the main driver.
Glenn Novarro:
Okay. Great. Thank you.
Daniel Florin:
You’re welcome.
Robert Marshall:
George, we have time for one additional question.
Operator:
Thank you, sir. Our next question comes from Matt Taylor with Barclays Bank. Please go ahead.
Matt Taylor:
Hi, thanks for taking the question. Can you hear me okay?
David Dvorak:
We can.
Matt Taylor:
Great. So two questions that are kind of related; one is, I just wanted to understand, I guess, where you are on the synergies. And given that you had already raised the net guidance once and you’re progressing pretty well here, can you talk to any potential to actually raise that number again and outperform your pre-tax synergy guidance?
Daniel Florin:
I’ll take that Matt. I think we’ve communicated before. First and foremost, we’re really pleased with the progress we’re making. The teams have done a terrific job driving that. It’s not been easy, but the teams been executing extremely well. And that manifests itself in that range, up to that 155 in year one. Importantly, to the extent that we’re able to exceed what we’ve communicated, we - first and foremost, we would look to reinvest that back into the business and in towards driving top-line growth. So I think that’s the right way to think about it.
Matt Taylor:
Okay. And then, Dan, you’ve mentioned a couple of times in the past kind of general comments on how you would approach getting your tax rate down over time. Can you talk about any specifics around that strategy? Because I noticed in your guidance you really don’t have a lot of tax leverage but you’re still significantly higher than peers.
Daniel Florin:
Yes, we are. And driving - the elements necessary to drive our tax rate down, frankly, first and foremost, begins with where you manufacture your products. And so, with the merger we have an opportunity to take a fresh look at our sourcing strategy in that regard, as well as where intellectual property is housed and so forth. And that’s why there is no quick fix to do that, but we do see a roadmap to drive the tax rate down. It’s something that we were successful with on legacy Biomet and there’s opportunity here on Zimmer Biomet to drive the same type of reduction. It will just take some time.
Matt Taylor:
Okay. Thanks a lot, guys.
David Dvorak:
Thanks, Matt. So with that I’d like to thank everyone for joining the call today and for your continued interest and support for Zimmer Biomet. We look forward to speaking with you on our first quarter conference call, which is scheduled for 8 AM on April 28. I’ll turn the call back to you, George.
Operator:
Thank you, sir. Ladies and gentlemen, thank you again for participating in today’s conference call. You may now disconnect.
Executives:
Bob Marshall - Vice President, Investor Relations, Treasurer David Dvorak - President and Chief Executive Officer Dan Florin - Chief Financial Officer
Analysts:
Bob Hopkins - Bank of America Merrill Lynch Mike Weinstein - JPMorgan Craig Bijou - Wells Fargo Securities Joanne Wuensch - BMO Capital Markets David Lewis - Morgan Stanley David Roman - Goldman Sachs Glenn Novarro - RBC Capital Markets Matt Keeler - Credit Suisse William Plovanic - Canaccord Genuity
Operator:
Good morning. I would like to turn the call over to Bob Marshall, Vice President, Investor Relations and Treasurer. Mr. Marshall, you may begin your call.
Bob Marshall:
Thank you, George. Good morning and welcome to Zimmer Biomet's third-quarter 2015 earnings conference call. I'm here with our CEO, David Dvorak, and our CFO, Dan Florin. Before we start, I'd like to note that our results reflect the same number of billing days in the current-year quarter as in the prior year. During our call, we will be comparing revenues on an adjusted pro forma basis. This means that the revenue per prior year period has been adjusted to reflect the inclusion of Biomet revenue, and the impact of previously announced divestiture remedies. Additionally, expense ratios and related margin analysis through operating profit will likewise be compared to pro forma financials, as revised, which include Biomet results for the same period in the prior year adjusted in both year periods for inventory step-up and other inventory manufacturing related charges, certain claims, special items, intangible asset amortization, financing, and other expenses related to the Biomet merger and certain tax adjustments. I would also like to remind you that our discussions during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements, due to a variety of risks and uncertainties. Please refer to our SEC filings for a detailed discussions of these risks and uncertainties. Finally, the discussions during this call will include other certain non-GAAP financial measures. Reconciliations of these measures to the most directly comparable GAAP financial measures are included within the earnings release, which is available on our website at investor.zimmerbiomet.com. With that, I'll now turn the call over to David.
David Dvorak:
Thanks, Bob. This morning, I will review our third quarter financial results and highlights from our performance. Dan will then provide additional financial details, as well as discuss our updated guidance. I'll state all sales in constant currency terms measured against prior year adjusted pro forma financials and all earnings results on an adjusted basis. Let me begin by highlighting some of our important achievements during the quarter. The company made great strides across all geographies by accomplishing significant commercial integration milestones. We largely completed the appointment of our global sales leaders during the quarter, and we expect to substantially complete all commercial integration efforts by the end of this year. As evidenced by our sequential sales improvement in the Asia-Pacific and Europe, Middle East, and Africa regions, as well as in several product categories, we have already begun to see the benefits of the progress we have made on our sales channel integration. Going forward, we will continue to execute our detailed cross selling plans, in order to leverage the depth and breadth of our musculoskeletal portfolio of solutions. During the quarter, we also began to execute our well defined road maps to capture the net operating synergies inherent in this merger. Our progress to-date is reflected in our adjusted earnings out performance, and continued delivery of expanded operating margins. I would now like to comment on market conditions and pricing during the quarter. Musculoskeletal markets in general continue to demonstrate stability, consistent with the prior two fiscal years. In terms of pricing, Zimmer Biomet experienced modestly negative pricing pressure, consistent with our prior expectations. Our resulting price decline in the third quarter was 2.1%. In this context, Zimmer Biomet accelerated revenue growth in several geographies and product categories. Consolidated net sales for the third quarter were $1.76 billion, an increase of 59.3% reported, or 0.7% against strong prior year adjusted pro forma results. Our Asia-Pacific business delivered 4.7% growth in the quarter, and our sales increased by 1.7% in the Europe, Middle East and Africa region. Revenues in the Americas decreased by 0.7%, reflecting flat sales in the United States, and the impact of macroeconomic issues in Latin America. Turning to our product categories, sales from Zimmer Biomet's knee business increased in the third quarter by 1.7%, reflecting positive volume and mix of 4%, and negative price of 2.3%. The strength of our combined knee portfolio is already evident by this quarter's robust performance in key overseas geographies. Our Asia-Pacific business delivered strong 9% growth over the prior year period. Our Europe, Middle East and Africa region grew sales by 6%, and our Americas segment recorded a sales decrease of 1.8%. Our sales growth continued to be led by Persona, the personalized knee system, and the clinically trusted Vanguard complete knee system, as well as our Vanguard 360 revision knee system. We also drove sales of our bicruciate preserving arthroplasty options, including the clinically proven Oxford Partial Knee and our new Vanguard XP Total Knee System. Sales from our hip business decreased by 0.3% in the third quarter, including positive volume and mix of 2.3%, and negative price of 2.6%. Our Europe, Middle East and Africa sales increased by 1.2%, compared to the prior year period. Our Asia-Pacific region sales decreased by 0.3%, and our Americas segment recorded a sales decrease of 1.1%. We're encouraged by our consolidated sequential revenue improvement, supported by the solid growth of our multi-bearing G7 and Continuum Acetabular Systems. In addition, the ongoing performance of our Taperloc Complete Microplasty stem and Avenir Hip System demonstrates how our comprehensive hip portfolio meets the rising demand for contemporary surgical techniques, such as the anterior supine approach. Turning to our SET product category, sales increased 1% over the prior year period. Our extremities business achieved high single-digit sales growth with solid performances in all geographies, due primarily to steady demand for the comprehensive Total Shoulder System. This growth was partially offset by the performance of our Surgical business, and to a lesser extent, trauma. We continue to be excited about the promising growth of our sports medicine business, where we're achieving ongoing traction with our Gel-One hyaluronic acid offering, and our minimally invasive Subchondroplasty joint preservation treatment. In the quarter, we announced the release of this innovative biologic solution for foot and ankle indications, representing our expansion into an attractive new clinical market. Worldwide dental sales decreased by 0.9% in the quarter. Our positive performances in the United States and Asia-Pacific region were offset by slower sales in the Europe, Middle East and Africa region, and the balance of the Americas. Looking to future quarters, our dental sales channel will remain focused on bringing critical scale and improved execution to all segments of this category, with a product portfolio that offers a breadth of implant systems and best-in-class regenerative solutions. Zimmer Biomet's Spine, CMS, and Thoracic category revenues increased by 0.3% over the prior year period. Our Spine sales teams continue to prepare to exploit our cross-selling product opportunities, which include the Timberline Lateral Fusion System and the PathFinder NXT Pedicle Screw System. We expect these commercial opportunities will help to offset anticipated sales to synergies inherent in our U.S. Spine integration in particular. In the quarter, a healthy double-digit growth rate for our craniomaxillofacial and thoracic business was driven by demand for our TraumaOne and SternaLock Blu Systems, as well as growing market acceptance for our recently launched RibFix Blu System. With that, I'll turn it over to Dan, who will continue this discussion in greater detail, as well as review our guidance. Dan?
Dan Florin:
Thank you, David and good morning. Our total revenues for the third quarter were $1.762 billion, a 59.3% increase as reported, compared to the third quarter of 2014. On an adjusted pro forma basis, total constant currency revenues increased 0.7% over the prior year, reflecting sequential growth from Q2. This is despite a relatively tough comp of 4.7% adjusted pro forma growth in the prior year quarter. Net currency impact for the quarter decreased revenues by 6%, or $113 million. The negative currency impact for the quarter related principally to our Japanese yen, euro, and Australian dollar denominated revenues. Our adjusted gross profit margin was 76.2% for the quarter. The margin ratio improved 70 basis points when compared to the third quarter of 2014. Ongoing but consistent price declines were offset by continuing gains from our cash flow hedging program, along with positive results from our manufacturing network. R&D expense in the quarter was $83 million or 4.7% of net sales. Our R&D teams have made good progress in reviewing and prioritizing projects within the combined portfolio, while also redirecting redundant project dollars towards innovative programs that address unmet customer needs. Selling, general, and administrative expenses were $692 million in the third quarter, and at 39.3% of sales, were 200 basis points below the prior year period. This reduction in SG&A as a percentage of sales is primarily reflective of cost savings from our synergy program, and to a lesser extent, efficiencies currently embedded across a number of spending categories, which provide future opportunity to fund additional organic growth initiatives. The cost synergy savings realized in the quarter included the benefit of certain actions that were implemented earlier in the quarter than previously projected. As such, we are updating our net synergy target for the first 12 months post close to $155 million, compared to the previous amount of $135 million. Approximately $15 million of the $20 million in accelerated year one savings were realized in Q3, with the remainder expected in Q4. The accelerated timing of these year one synergy initiatives does not impact our year three EBIT run rate synergy commitment of $350 million. In the quarter, the company recorded pretax charges of $439 million in special items, which primarily consist of amortization expense of $123 million, inventory step up charges related to the Biomet merger of $127 million, and approximately $140 million in integration related costs. Our adjusted third quarter 2015 figures in the earnings release exclude the impacts of these charges. Our adjusted operating profit in the quarter amounted to $567 million. At 32.2%, our adjusted operating profit to sales ratio was 270 basis points higher than the prior year third quarter. Net interest expense for the quarter amounted to $89 million, which was higher than the same prior year quarter, and reflects the incurred debts associated with the Biomet transaction. Adjusted net earnings were $338 million for the third quarter, an increase of 35.5% when compared to the Zimmer standalone adjusted net earnings from the prior year. Adjusted diluted earnings per share increased 13.1% to $1.64 on 205.7 million average outstanding diluted shares. At $0.11, reported diluted earnings per share decreased 89.1% from the prior year third quarter reported EPS of $1.01. Our adjusted effective tax rate for the quarter was 28.2% and 30.2% on a reported basis. The company had approximately 203.7 million shares of common stock outstanding as of September 30, 2015, an increase as compared to the 169.3 million as of September 30, 2014. The increase is due primarily to the 32.7 million shares issued in connection with the Biomet transaction. Operating cash flow for the quarter amounted to $151 million compared to $256 million in the third quarter of 2014. The decrease was driven primarily by integration expenses tied to our synergy program of $102 million, and final expenses related to the merger transaction of $225 million. Free cash flow in the third quarter was $15 million, reflecting CapEx spending of $136 million, which was comprised of $82 million for instruments, and $54 million for property, plant and equipment. During the quarter, we repaid $150 million on our term loan from funds on hand in the United States. The outstanding balance on the term loan as of September 30th was $2.850 billion. I would like to now turn to our guidance for 2015. In our earnings release this morning, we updated the company's expectations for full year 2015 revenues and earnings. Implicit in this guidance is a stable to slightly improved revenue performance in the fourth quarter, relative to our growth rate in Q3 after adjusting for billing day shortfalls expected in that quarter. Revenue growth for the fourth quarter is expected to be in a range of 0.5% to 1.5% on a constant currency adjusted pro forma day rate basis. I would remind you that the fourth quarter will have one-half less billing day, in consolidation, which is inclusive of two fewer billing days in the EMEA region, due to an accounting change that we made earlier this year for certain of our international entities. Adjusting for the one-half less billing day difference, which negatively impacts the growth rate by approximately 75 basis points, our adjusted pro forma constant currency growth is expected to be in a range of negative 0.25% to positive 0.75%. Taken together with an expectation of foreign exchange impact of negative 4.5%, our reported revenue for the fourth quarter is expected to decrease between 3.75% and 4.75%. The company now forecasts full year revenues to increase between 1% and 1.5% constant currency, on a comparable adjusted pro forma basis when compared to 2014. The resulting full year revenues would therefore be approximately $6.01 billion. We now expect the gross margin ratio for the full year to be at the high end of the previously guided range of 75% to 75.5% and within that range in the fourth quarter. Our guidance for R&D is now approximately 4.5% for both the fourth quarter and the full year. We now expect SG&A as a percentage of revenues to be below the low end of the previous range of 38.5% to 39% for the full year and between 37% and 37.5% for the fourth quarter. Moving down the income statement, net adjusted interest expense guidance remains unchanged, while the estimated full year tax rate is now expected to be approximately 26.5%. Our previous guidance had been in a range of 26.5% to 27%. Taken together with year-to-date performance, the fourth quarter's adjusted tax rate should be approximately 25.5%. We expect fully diluted share count for the fourth quarter should be approximately 206 million shares, and approximately 190 million for the full year. I would like to note that given the significant movement in fully diluted share count during 2015, the full year adjusted earnings per share results will differ from the simple arithmetic sum of each quarter's adjusted earnings. Our full year adjusted EPS guidance range reflects cumulative adjusted net income, divided by the full year diluted share count of 190 million shares. Turning now to capital allocation, as noted in our press release this morning, the company is reinstating its previously suspended share repurchase program. The program that authorized the repurchase of shares up to $1 billion was temporarily suspended in April of 2014, when the Biomet merger was announced. As a reminder, the company has $599.5 million of share repurchase authorization remaining as of September 30, 2015. Full year 2015 adjusted and fully diluted earnings per share guidance has been updated, and exceeds the high end of our previous range of $6.65 and $6.80. We now forecast adjusted fully diluted earnings per share to be in a range of $6.83 to $6.87 on the 190 million fully diluted share count. Our adjusted EPS for the fourth quarter is expected to be in a range of $2.02 and $2.06, again using a 206 million fully diluted share count. Before turning the call back over to David, I want to inform you that late in the quarter, we identified errors in legacy Zimmer's accounting for certain accruals, and our Q2 accounting of product line divestitures. The errors impact several prior operating periods. The company assessed the applicable guidance issued by the Securities and Exchange Commission and the Financial Accounting Standards Board, and concluded that these misstatements were not material to Zimmer Biomet's historical consolidated financial statements. However, due to the low Q3 reported net income of $22.2 million, the company concluded that correcting these prior period errors in the current quarter would have been material to the Q3 consolidated statements for GAAP earnings. As a result, the company is revising prior period financial statements to reflect the proper timing of these adjustments, along with all previously determined immaterial adjustments in their respective periods. To be clear, we are not restating any previously issued filings, rather we are making immaterial revisions to the prior periods. The most notable revision is a downward adjustment of $0.05 of adjusted earnings per share recorded in the first half of 2015. Importantly, the impact of this revision on 2015 adjusted fully diluted earnings per share has been considered within today's updated guidance. Further, it has no impact on our view of the performance of the business. A reconciliation of the revision amounts and timing from 2013 to 2015 is available on our Investor Relations website, and is included in Form 8-K that we filed today. Lastly, as a reminder, we will be providing detailed 2016 financial guidance during our fourth quarter earnings call in January. David, I'll turn the call back over to you.
David Dvorak:
Thanks, Dan. As a global leader in musculoskeletal innovation, Zimmer Biomet is uniquely positioned to anticipate and serve the needs of an evolving healthcare environment. We're excited about the progress of our teams and the course of our global integration and we will remain focused on capturing the synergies of this merger at every level. Together, we're accelerating the company's growth strategies, while generating attractive stockholder returns. And now, I would like to ask George to begin the Q&A portion of our call.
Operator:
[Operator Instructions] Our first question comes from Bob Hopkins with Bank of America Merrill Lynch. Please go ahead.
Bob Hopkins:
So David, it looks like you're doing a really good job on the cost side. I wanted to focus my question on kind of sales growth and sales force retention and integration progress. So I guess the way I would ask the question is, when you look at the Q4 guidance, adjusting for days, it looks like the sales growth in Q4 is maybe a little lighter than Q3. Can you just talk a little bit about why that is? And more broadly, how are things going in terms of sales force retention and turnover? Are the turnover rates what you expected? Just a little more color in what is going on with the integration so far.
David Dvorak:
Sure, Bob. Obviously in the third quarter, our focus was on appointment of sales leaders out in the field. These were steps that we were unable to take prior to close, although we had very detailed plans. And so it's been an execution quarter where we have done a lot across the globe to clarify future leaders and then allow those individuals to form their teams all the way down to the rep level. So some of that second half piece that is clarification of territories, compensation plans, product bags, is work that is ongoing and we expect to be substantially complete with all of that work by the end of the year. Now, that said, we're already seeing positive traction, having made these leadership appointments and that's evident in our performance, in the OUS markets in particular. There are pockets and product categories within the United States market where that is already evident. Retention rates have been consistent with expectations. Obviously, when these decisions are made, one expects a little bit of an impact in that regard, and so we did see an expected uptick. But we're also seeing a pipeline of new sales positions and hiring activities picking up and so all of that bodes very, very well as we finish out 2015 and move into 2016. This positions us extraordinarily well to take advantage of the cross-sell opportunities, and so we expect to see a bit of that retrieved in the fourth quarter here, and then sequentially throughout 2016, more and more of that will be realized on the cross-sell opportunity. What we're forecasting really is stability, Bob, sequentially, from Q3 to Q4. There's a billing day impact that causes three-quarters of a point headwind in our constant currency growth rate. But when that's factored in, our sales guidance range contemplates stability to potentially a little bit of an uptick from Q3 to Q4.
Bob Hopkins:
Okay. Thank you for that. Then as a follow-up, I realize this is a slightly shorter-term oriented question, but can you walk us through, relative to the guidance that you gave last quarter, why the revenue growth guidance is down a little bit this quarter? Maybe just put that into context for us, just what changed? For Dan, I was just wondering, you guys previously had said, regarding 2016, that earnings growth would be 15% to 20% higher than 2015, I believe. And so does that still hold, relative to this higher 2015 number? Thank you.
David Dvorak:
Sure, Bob. Let me take the first of those. The consistency expected in Q4 and what we saw in Q3 across all the primary businesses is noted and I think that the only significant change that exists relative to our view of the market falls in the category of emerging markets. And I think that this is something that others have seen. It is macro economically driven. It obviously impacted our Americas performance most prominently, because we saw the biggest downturn in our Latin America business out of the emerging markets. Frankly, we saw less of a downturn in Asia-Pacific and hence the stronger performance was contributed in that regard. And then more of a flattish emerging market performance in the EMEA businesses, consistent with our overall performance there. So that headwind, particularly in Latin America, but across the various emerging markets, is the reason for the tweak to the guidance from Q3 to Q4. Everything else is tracking absolutely consistently with our plans and expectations.
Dan Florin:
And, Bob, with respect to 2016, certainly our performance in 2015 gives us strong confidence with respect to 2016. As I mentioned, we will provide detailed guidance in our January call. Importantly, our 2016 operating plan is well underway, and within that context, we will make decisions about resource allocation and funding of growth initiatives. And as you said, we have express confidence in EPS, 15% to 20% off the prior EPS range of $6.65 to $6.80. The analyst community has collectively construed that as 15% growth off of the high end of that range of $6.80, which yields something in the $7.82 range. I would say that's probably a good way to think about it for where we are right now and we will provide the detailed guidance in January. And, again, as we have spoken about, as 2016 progresses, the cross-sell opportunity is realized. We will be working towards achievement of market growth rates, as we progress through 2016.
Bob Hopkins:
Very helpful. Thank you.
Operator:
[Operator Instructions] Our next question comes from Mike Weinstein with JPMorgan. Please go ahead.
Mike Weinstein:
Thanks. And just a quick follow-up there, is that basically you're comfortable with the current Street consensus for 2016?
Dan Florin:
That's correct.
Mike Weinstein:
Okay. David, the -- I've been trying to track what some of the actions you guys have taken to-date and it feels like a lot of what you have done on the sales front is consolidate sales management, while leaving the actual sales personnel intact. Is that -- A, is that accurate; and B, my question is, as you go into a distributor or go into a territory where you're direct, particularly on the distributor side, and you say to the distributor, hey, the Biomet distributor or in the other case the Zimmer distributor has a better presence in this territory, better market share, we're going to give responsibility for this territory to this other distributor, but we're going to keep your sales people, we're going to keep your reps. How does that work? And how is that not immediately disruptive to that business in that territory? If you can just walk through those conversations, that would be great.
David Dvorak:
Mike, those decisions are unique and very fact and circumstance oriented. It can be a situation where you end up continuing to work with each of those sales leaders, but generally speaking, the scenario that you paint is a true one. You have two sales leaders. You're going to select one, configure a territory that is going to be historically the strongest sales leader performance wise, their growth track record, their capability to select talent and execute the commercial plans has been superior. I will tell you, in the case of those leaders selected, that differential is between them and the non-selected. In the U.S. recon SET channel is about a 300 basis point difference. So it's substantial. And it's really a benefit of the combination to be able to select from a pool of competent sales leaders and select the best-of-the-best to take the organization forward. Now that said, we said from the beginning that we were continuing to preserve the sales representative positions, and that holds true through our integration plans. The comprehensive product portfolio puts us in a position where we need all of those sales positions to fully realize the opportunities that we have out in the marketplace. These were obviously sales positions that were busy and fully occupied, and servicing customers prior to the deal and they continue to do so. So it's a matter of transitioning over those sales reps into the go forward structure, whether that's a hybrid or an independent sales model, and it's different in different geographies, and take those sales reps, integrate them into one team, cross train them on the other company's products bag and start to go after running the execution of the offense. So that's the state we're in now. And I would tell you, it's going very well and probably the overarching reason is we had good plans, we had good sales and other leaders executing those plans. But at the sales rep level, they're enthusiastic about the product portfolio. As they get exposed through these cross-training efforts and gain deeper knowledge of that product portfolio, they see their opportunities going forward to grow their businesses and continue to make a good living. So the execution has gone very smoothly, and the pipeline build for the cross sell opportunities is creating nice visibility, and we believe it will be expressed on the scoreboard as we move into 2016.
Mike Weinstein:
Okay. Just one follow-up for Dan. The reinstatement of the share repurchase authorization, can you just help us with how you want us to think about that, given the debt on the balance sheet from the acquisition? How aggressive do you want to be? And obviously recognizing as well that you will have access to a fair amount of OUS cash shortly. How aggressive should we think about a buy-back over the next 12 months?
Dan Florin:
Sure, Mike. In December, we will have access to -- we will complete the intercompany loan transaction, which opens up the access to our OUS cash. That has always been a necessary step, so we're on target for that in December. We have reinstated the program. So the table has been set. I would tell you, certainly in our January guidance we will give explicit details on what our plans are in 2016. But I would just ask you to think broadly about our capital allocation policy as it has always been, which is being very disciplined in the deployment of that capital, considering the returns and our weighing options for the best use of those excess funds. I would say that our priorities include funding our organic growth initiatives, funding our synergy program given the return profile of that, maintaining our dividends in proportion to earnings, and deleveraging the balance sheet that meets our leverage goals. M&A that meets our financial hurdles, and then share repurchases to the extent we have excess cash, and those returns are attractive at that point in time. So that's how I would think about it, and that's how we're approaching it as we come into 2016.
Mike Weinstein:
Okay. Great. I'll let someone else jump in. Thanks, guys.
Operator:
The next question coming from Larry Biegelsen with Wells Fargo Securities. Please go ahead.
Craig Bijou:
Actually it's Craig on for Larry. First question, I wanted to talk about the Americas business. I appreciate the color on the Latin American weakness, but I did want to talk about the flat U.S. growth. How does that compare to the pro forma growth you saw in Q2? And then, how do you see that progressing sequentially, relative to some of your comments on the whole company growth?
David Dvorak:
Sure, Craig. That sequentially from Q2 to Q3, that's a slight decline in Americas and a substantial contributor to that decline again, were the Latin American markets. But we would expect that core Americas business and the U.S. business in particular to show stability to slight improvement as we move into the fourth quarter.
Craig Bijou:
And then, I mean in terms of 2016, is it a similar -- I guess the question is, do you expect increased disruption, at least in Q4, or maybe early 2016, or do you see a sequential improvement like you do on the worldwide growth?
David Dvorak:
Yes. Sequential improvement throughout 2016 is the way to think about it at this point in time and it can be different in different product categories. As we noted, the expectations for this synergy is because of the inherent nature of the integration on the U.S. Spine side is more profound than it is on the large joint or SET business. But certainly the large joint SET business having clarified roles and responsibilities down to the rep level by the end of this quarter and moving into 2016, we would expect thereafter to realize the cross sell benefits, and show sequential improvement throughout that year.
Craig Bijou:
Okay. Thanks. That's helpful. Just as a quick follow-up, Dan, is there any preliminary P&L color that you can give for 2016? Maybe relative to the guidance that you provided for 2015?
Dan Florin:
Craig, I would go back to the earlier comments relative to our previous comments of 15% to 20% off of the prior guidance. Our earnings performance in 2015 increases our confidence with respect to earnings in 2016, but I would point to what seems to be the Street consensus that is out there as an area that we're comfortable with, currently.
Craig Bijou:
Okay. Thanks, guys, for taking the questions.
Operator:
Our next question comes from Joanne Wuensch with BMO Capital Markets. Please go ahead.
Joanne Wuensch:
You said in part of your prepared remarks that there were certain regions that you're seeing the benefits of the combined organization. Can you talk about what those regions are, what you're seeing, and then how do you leverage that to the places that not happening in yet?
David Dvorak:
Sure, Joanne. I think, most prominently you can see the sequential improvement and strong performance, likely market share gain performance, already in the overseas markets, both Asia-Pacific and Europe, Middle East and Africa. And what's noteworthy there is, in a big business with a leadership position, we grew our knee business in Asia-Pacific upper single digits, and in Europe, mid single digits and those are share gain numbers in both of those markets. So some of that opportunity is dependent upon the channel structure and the cadence of the integration plans, we're able to get after those opportunities sooner. I think what it does though, is validates that the combined company product offering is extraordinarily strong. And as we get deeper into the integration and moving towards a more offensive execution mode as a company in other jurisdictions, most importantly the United States, among the geographies, then we're going to start to realize those benefits in that important market, as well.
Joanne Wuensch:
That's helpful. As a follow-up, we've been spending almost all of the last year and a half talking about the merger between the two companies and the benefits, and worrying about the dis-synergies. If we look forward next year, can we think about new products, or is there something that you can start to highlight to frame that out for us? Thank you.
David Dvorak:
That's a good point. The short term opportunity, and it's the reason that we have all probably been over indexed on it is, the existing product offering really represents the mother of all launches for both sides, the legacy Zimmer and the legacy Biomet side because they're picking up new products that are innovative. They may be gap filling for that respective sales rep and so there's a lot of energy around that to get that moving. But I would tell you it's equally exciting to us as we have come together and prioritized the pipeline of innovative products, to look ahead and see what we have to launch. We're extraordinarily excited about how that comes together. I think you're going to see an incredible cadence of new offerings, by virtue of the combination. What it allows us to do in the intermediate to longer term is to repurpose dollars into more differentiated innovation, and get after it in a more aggressive way addressing unmet clinical needs because of the scale that we have as a business, not just in large joints, but in the other product categories that are oftentimes faster growing markets. So we will highlight for you, as we move into full commercialization of some of those products. There are a few of them that are really important that are on a more limited release at this point in time. And we will come back to you, Joanne, and highlight those as we move those into full launch. Don't want to get out of that process for obvious competitive reasons, but it's a powerful pipeline, and it's going to be a quick pace of cadence, and sustain that top line growth as we get that restored in the intermediate and long-term.
Joanne Wuensch:
Thank you very much.
Operator:
Our next question is from David Lewis with Morgan Stanley. Please go ahead.
David Lewis:
David, it sounds kind of reading through all this commentary, that you're starting to see stabilization in your core business here in the early days of the merger. But obviously EMEA is a bit slower. So we have heard this comment from several orthopedic providers. Do you have a sense of whether this EMEA slowdown is tied to distributor destocking and what I'm specifically asking is do you have decent enough visibility on underlying demand to feel decent about your fourth quarter assumptions?
David Dvorak:
Yes. We do. And we have very good visibility in those markets, David, as to what was happening in Q2, with the pending close moving into Q3 and the stabilization appointment of sales leaders irrespective of the channel structure in those geographies. As it relates to the emerging markets that market did slow down in EMEA and I would tell you it moved more towards a flattish growth number. We continued to have nice growth coming out of Asia-Pacific, and we can disaggregate what of that is integration related versus seemingly market. And then there's no doubt that when it comes to the Latin American emerging markets, that there was a substantial slowdown, and we would expect that to continue because of the macroeconomic underpinnings to it.
David Lewis:
Okay. And then just going back to the buyback here for a second. Dan, a lot of -- what I heard in response to Mike's question was more of a tempered approach to the buyback. Not all companies, but a lot of companies kind of look at two factors in thinking about the buyback. Business visibility, and obviously relative valuation of the stock. I think most people would agree that the valuation is somewhat compelling. It sounds like from David, the business visibility is sort of returning. So am I reading you correctly that the approach to the buyback is more tempered because it seems like a more opportune time to be less tempered and more aggressive? Thank you.
Dan Florin:
David, I would say that we are looking at that within the context of the 2016 operating plan. And we'll -- as we look at excess funds, we get that cash access to OUS creates that opportunity. We will be disciplined, I guess is the right way to think about it and opportunistic, when it makes sense. I would leave it at that. The table is set, and we will proceed accordingly.
David Lewis:
Okay. Thank you very much.
Operator:
Our next question is from David Roman with Goldman Sachs. Please go ahead.
David Roman:
I want to maybe just to go into some of the details of the businesses and go back to the SET franchise. I think in your prepared remarks, you said extremities grew in the high single digits. So maybe you could help just dissect for us in a little bit more detail what is happening in the Trauma and Surgical franchises? And then specifically what are some of the factors we should be monitoring to bring the growth rate of that business up, perhaps to something closer to what you're seeing in the extremities franchise?
David Dvorak:
Yes. A lot of that is just germane to the cadence of our integration efforts in general, David. But we did see a strong performance, and some pretty substantial sequential improvement, as it relates to the extremities business. That's a leadership position business for us, so obviously very, very important. And it is an early sign of how powerful the combined product portfolio is going to be in that category. Executing on some of those opportunities in the other categories embedded within SET, we're expecting to take a bit more time. But I would tell you that we have good visibility in the coming quarters to improvement in those categories, too. And our expectation here is to work that business from where it is to up to mid single digits, and ultimately to high single digits in growth, because of the nature of those categories. So, right now we have to improve our performance in categories like Surgical and Trauma in particular, and those businesses were slightly down. More so in Surgical's case than Trauma. But, again, I think that as we move through and develop a more focused sales force effort at the sales rep level on a global basis, we have got the scale and the comprehensive nature of the product portfolio justifies those specialized sales forces across the globe to exploit the opportunities and bring more focus to those markets. And it's a major premise to the combination itself.
David Roman:
Okay. That's helpful. Maybe just a follow-up on R&D spending. I know you have talked about in the past taking the two companies' R&D dollars and combining them and reallocating resources to higher-growth areas, which you talked about in your comments. But if I just simplistically take the R&D in the quarter and multiply by 4 that is $40 million on a run rate basis lower than where the combined entities were doing, I think it's something close to $370 million or so. Is that more a factor of timing, of allocating those dollars, or are you seeing opportunities within R&D to see some cost savings as you kind of go through the integration plan? And to what extent could that represent upside to the three-year synergy targets that you have provided?
David Dvorak:
Yes. It is not a targeted area for synergy, David. It really is an area that we would expect to be more at that prior combined run rate that you noted, as opposed to what's reflected in Q3. That said, this is an area where obviously we were walled off from open sharing of pipeline projects until the close. So those teams are just getting into the hard work to examine those projects, and so as a consequence, there just is a moderation of spend that you ought to expect to see step back up and reflect something more towards the sum of those two line items pre-close.
David Roman:
Okay. Great. Thank you very much.
Operator:
Our next question comes from Glenn Novarro with RBC Capital Markets. Please go ahead.
Glenn Novarro:
I wonder if you could elaborate a little bit more on the accelerated cost savings that you saw in the third quarter. I'm assuming this is mostly headcount, but was this mostly in SG&A? And as a follow-up to that, do you think that you can accelerate the cost synergies and savings entering year two? And then I had a follow-up on the gross margin.
Dan Florin:
Sure, Glenn, this is Dan. With respect to the synergies this quarter, importantly these were programs already on the road maps. We were just able to pull the trigger on those earlier than contemplated. So that brings an incremental benefit to calendar '15 and the first year post closing. I think maybe by way of example, think about a duplicate office lease agreement that was in place and our original projections perhaps had that termination of that lease set for October, but we were able to terminate that in August. And that couple of months of savings, by virtue of that lease was pulled into 2015. So that's why it doesn't affect the run rate. That lease is worth a certain amount on an annualized basis. That's unchanged, as we move forward. So it really was a timing issue, an acceleration of planned for initiatives on the synergy front. I would also say -- we're very confident in the $350 million year three run rate synergies. I would also say to the extent that there is further opportunity to exceed on the synergy side, we're going to be very smart about reinvesting that over performance on synergies into growth initiatives. Back to the theme of getting the top line accelerated, getting back to market growth rates, above market growth rates, we will invest in those areas, and make prudent decisions about what we drop through versus invest on any over performance on the synergies moving forward.
Glenn Novarro:
Thanks. And just quickly on the gross margin, it looks like 4Q guide, the gross margin sequentially may be down from the third quarter. Is that purely a function of the less selling or less billing days in the fourth quarter, or was 3Q elevated because of currency? I'm just trying to understand the slight down tick in the gross margin from 3Q to 4Q.
Dan Florin:
Sure. In the fourth quarter, the gross margin is expected to come down slightly, primarily due to less gains on our foreign currency hedge contracts. So as those gains will start to step down from the Q3 level as we progress in Q4 and into next year. And that will put some pressure on the gross margin rates, beginning in Q4, and then progressing through next year.
Glenn Novarro:
Okay. Great. Thanks, Dan.
Operator:
Our next question is from Matt Keeler with Credit Suisse. Please go ahead.
Matt Keeler:
I guess just a follow-up on the last question. Can you give us a sense of what the magnitude of FX benefits has been year-to-date, and what that implies for a drag next year?
Dan Florin:
Sure, Matt. From an earnings per share perspective, foreign currency has been a significant headwind in 2015. So when you account for the translation loss of revenue, and the impact that has on reported earnings in U.S. dollars despite our hedging gains, there is still a significant FX impact at the EPS line and that impact is in the neighborhood of 7% of EPS headwind. That's the magnitude from an EPS dollar perspective. From a rate -- a margin ratio perspective, less impactful. But on a dollar basis, it's that type of significant. So if rates were to hold where they are today, and we look out through 2016, and we will provide more color in January on this. As I just mentioned, the dollar benefit of our FX hedge gains does decrease in 2016 relative to 2015 and that will create some pressure at the margin rate line, as well as from an EPS dollar perspective. And that will all be fleshed out in January in that detailed guidance.
Matt Keeler:
Thanks. That's helpful. And just back to LatAm, I'm wondering, were there businesses that were affected more than others, or was it broad based? And then could you give us a sense of combined Zimmer Biomet, sort of what the Americas exposure is to LatAm?
David Dvorak:
Yes. The business is not a large business in the scheme of things. But the downturn was significant in the context of the quarter, and is anticipated to continue in Q4. So it really is across all product categories within the Americas unit, so you can't isolate any single product category and its influence. I would tell you that the emerging market as it represents our total consolidated revenues, is somewhere in the 7% to 8% range, and it's probably less significant just by sheer size, in the context of Americas relative to the other two geographic segments.
Matt Keeler:
Okay. Thanks. That's helpful. Thanks for taking my questions.
Bob Marshall:
George, we have time for one additional question.
Operator:
And our final question comes from William Plovanic with Canaccord Genuity. Please go ahead.
William Plovanic:
Just a clarification, I think a lot of people have tried to circle around this Latin America issue. If you looked at your U.S. total joint business, just the U.S., separated out from the Americas, would that have been flat up or down year-over-year? And then my second question is really more of a broad based question with the CCJR in mind and bundling long-term. Do you see any advantage to becoming a more vertically integrated player in orthopedics, adding call points, distribution into the office or rehab channel, given the size of the product offering at this point? Thank you very much.
David Dvorak:
Sure. If one disaggregates the revenue source within Americas and backs out Latin America, our business would have been on the U.S. front, flat to slightly positive in the quarter. And let me come back to CCJR. I do think that there's a lot of opportunity, and we've been innovating in a manner to exploit those opportunities. Thematically, we believe that finding innovations that address unmet clinical needs and help providers, payors, HCPs deliver care in a way that enhances the quality of the outcome, at the same time that the costs are managed more efficiently, is where the world needs to go. And we think that proposals like CCJR are just expressions of that reality. So we feel like, if anything on a combined basis, we're uniquely positioned to address those demands in that evolving health care environment. And rest assured that both from clinical as well as service and solution innovations, that we would look to be an integrator and a more comprehensive provider of solutions in that context.
William Plovanic:
Great. Thank you. And just for clarity, it was total joint, so knees and hips in the U.S. was flat to slightly positive year-over-year?
David Dvorak:
Yes. Large joints would have been slightly negative. All product categories, excluding Latin America, would have been flat.
William Plovanic:
Great. Perfect. Thank you very much.
David Dvorak:
So with that, I would like to thank everyone for joining the call today, and for your continued interest and support for Zimmer Biomet. We look forward to speaking with you on our fourth quarter conference call which is scheduled for 8:00 AM on January 28, 2016. I'll turn the call back to you, George.
Operator:
Thank you, sir. Ladies and gentlemen, thank you again for participating in today's conference call. You may now disconnect.
Executives:
Bob Marshall - Vice President, Investor Relations, Treasurer Jim Crines - Retiring Executive Vice President and CFO David Dvorak - President and Chief Executive Officer Dan Florin - Chief Financial Officer
Analysts:
Janne Wuensch - BMO Capital Markets Bob Hopkins - Bank of America/Merrill Lynch Mike Weinstein - JPMorgan David Lewis - Morgan Stanley Craig Bijou - Wells Fargo Securities David Roman - Goldman Sachs Richard Newitter - Leerink Partners William Plovanic - Canaccord Genuity
Operator:
Good morning. I would like to turn the call over to Bob Marshall, Vice President, Investor Relations and Treasurer. Mr. Marshall, you may begin your call.
Bob Marshall:
Thank you, Ben. Good morning, and welcome to Zimmer Biomet's Second Quarter 2015 Earnings Conference call. I'm here with our CEO, David Dvorak; our CFO, Dan Florin; and Jim Crines, Retiring Executive Vice President and CFO. This morning we'll be discussing the recently announced closure of our combination with Biomet. We will also briefly cover Zimmer's second quarter 2015 financial results. Additionally, the company has posted a slide presentation highlighting reported changes and selected combined historical financials on our Investor Relations website. Before we start, I’d like to remind you that our discussions during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements, due to variety of risks and uncertainties. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties. Also, the discussion on this call will include certain non-GAAP financial measures. Reconciliations of these measures to the most directly comparable GAAP financial measures, are included within the earnings release, or found on our website at investor.zimmerbiomet.com. With that, I'll now turn the call over to Jim.
Jim Crines:
Thank you, Bob. I will make some brief remarks on second quarter results, and then turn the call over to David and Dan. With respect to our sales commentary for the Zimmer legacy product categories, I will provide quarter over prior year quarter changes, absent acquired Biomet revenue and adjusted to reflect fewer selling days for certain international markets in the current year quarter. Pro forma comparisons to the prior year quarter can be found on the Investor Relations section of our corporate website. Turning now to our results. Zimmer experienced a price decline of 2% in the quarter, which is consistent with our expectations coming into the year. Total revenues for the second quarter were $1.168 billion, a 5.7% constant currency increase, compared to the second quarter of 2014. Net currency impact for the quarter decreased revenues by 7% or $83 million. Acquired revenue from the Biomet transaction contributed 5% or $60 million in the quarter. Therefore Zimmer standalone sales increased 0.7% or 1.2% on a like-billing day basis in the quarter. During the quarter, excluding acquired revenue and on a billing day adjusted basis, the company grew Knees at 2.7%; Hips and Extremities each decreased 0.6%; Dental revenues grew 0.7%; Trauma as well as Surgical and other sales were flat; and Spine sales increased 5%. Geographic sales also absent acquired Biomet revenue and on a billing day adjusted basis were as follows. Americas, plus 0.5%; Europe, Middle East and Africa grew 1% and Asia-Pacific increased 3.7%. Our adjusted gross profit margin was 76.4% for the quarter. A favorable geographic segment mix of revenues, together with foreign currency hedge gains and favorable year-over-year comparisons with regard to manufacturing variances, were partially offset by the impact of negative price. The company's R&D expense compared to the prior year increased 7.1% or $3.4 million on a reported basis to 4.4% of net sales. Selling, general and administrative expenses were $445.1 million in the second quarter, and at 38.1% of sales were 120 basis points above the prior year. During the quarter, the company reported certain non-recurring pre-tax expenses, including $465 million of charges relating to the Biomet merger and $90 million of special items and certain claims. Additionally, pre-tax amortization expense in the quarter was $34.9 million. Adjusted second quarter 2015 figures in the earnings release exclude the impact of these charges. Adjusted operating profit in the quarter amounted to $395.3 million. At 33.8%, our adjusted operating profit-to-sales ratio was 160 basis points higher than the prior year second quarter. This marks the eighth quarter in a row with operating margin improvement. Adjusted net interest expense for the quarter amounted to $18.7 million, which was unfavorable when compared to the prior year quarter due to the inclusion of acquisition-related debt and adjusted earnings, following the Biomet merger. Our adjusted effective tax rate for the quarter was 25.9% and was 20 basis points favorable, when compared to prior year. Adjusted net earnings were $278.7 million for the second quarter, an increase of 2.8% compared to the prior year. Adjusted diluted earnings per share increased 0.6% to $1.59 on a 175.6 million average outstanding diluted shares. The company recorded a loss per share of $0.91 on a GAAP or reported-basis for the quarter. The loss is due principally to expenses incurred during the quarter in connection with the Biomet merger. This compares to the prior year second quarter reported EPS of $1.03. Operating cash flow for the quarter amounted to $186.8 million, a decrease of 26.5% from $254.1 million in the second quarter of 2014. Cash outflows in the second quarter related to the merger transaction amounted to $108 million. Depreciation and amortization expense for the second quarter amounted to $99.6 million. Free cash flow in the second quarter was $114.8 million; $44.7 million lower than the second quarter of 2014. We define free cash flow as operating cash flow less cash outlays for instruments and property, plant and equipments. Capital expenditures for the quarter totaled $72 million, including $41.6 million for instruments and $30.4 million for property, plant and equipment. As expected, as of June 30, our gross debt was $12.05 billion or 4.1x our trailing 12-month adjusted EBITDA and our net leverage ratio including cash on hand and short-term investments was 3.5x adjusted trailing 12-month EBITDA. As this is my final investor call, I just want to say that it has been a pleasure to work with all of you, and be part of the dedicated and highly talented team of people here at the company for the last 15 years. As I step out of this role, I look forward with excitement at the value creation opportunities this new team will be pursuing with the same tenacity that drove past accomplishments at both companies. David, I'll now turn the call over to you.
David Dvorak:
Well, thanks for your many contributions to the company over the years, Jim. This morning, I'll focus my comments on some of the key value creation opportunities presented by our landmark combination with Biomet. In short, the synergies inherent in this merger will accelerate the execution of our primary commercial and innovation growth strategies, while at the same time enabling the company to generate extremely attractive financial results. By virtue of possessing a significantly broadened and truly comprehensive portfolio of innovative musculoskeletal solutions, Zimmer Biomet is in an excellent position to accelerate top line growth over the course of our global integration, principally through a host of cross selling opportunities between our two legacy portfolios. Our integration teams have already achieved key milestones in support of these commercial opportunities, including the implementation of critical sales infrastructure and the completion of initial product trainings, which have supported our ability to begin deploying specialized commercial teams in key product categories and geographies. We expect to substantially complete our commercial integration by the end of this year, including the appointment of just over 2,000 specialized sales representatives concentrating in non-large joint sales opportunities, a number that we aim to further expand significantly throughout this decade. Our vision is to build the most highly specialized and effective musculoskeletal commercial team in the industry. Consistent with that goal, we selected sales leaders with proven track records and designed compensation plans that reward growth. We expect to begin realizing the benefits of our integrated sales channel, as well as these commercial opportunities in the form of sequentially accelerating revenue growth, as we exit 2015 and progress through 2016. As a leader in the nearly $50 billion musculoskeletal industry, Zimmer Biomet's portfolio of solutions offers unparalleled anatomical coverage, as well as reach across the full continuum of care from minimally-invasive and biologic joint preservation technologies, to partial, total, revision and salvage arthroplasty systems. I’d like to take this opportunity to highlight a number of the complementary portfolio offerings that our sales organization will be aggressively leveraging. Our market-leading Knee business continues to be led by Persona, the personalized knee system, and our clinically trusted Vanguard and NexGen knee systems. In addition, our impressive knee lineup includes the Vanguard Select and Vanguard 360 revision system. Finally, our portfolio is further differentiated by our bicruciate preserving arthroplasty options, including the clinically-proven Oxford Partial Knee, and our new Vanguard XP Total Knee System. In Hips, our offerings address the full-range of patient anatomy and surgical philosophies. Our Taperloc Complete Microplasty stem and Avenir Hip System for example, meet the rising demand for minimally invasive techniques that incorporate the anterior supine surgical approach. Our portfolio is also complemented by the Arcos Femoral Revision System, and our multi-bearing premium cup options featuring the G7 and Continuum Acetabular Systems. Within our newly formed SET product category, we see our Sports Medicine business as a particularly attractive source of quick wins across our sales channel. Joining our early intervention Gel-One and Subchondroplasty treatments, the JuggerKnot Soft Anchor System marks our expansion into this fast growing market. We're bullish on the union of our complementary extremities portfolios, highlighted by the cross-selling opportunities represented by the comprehensive Total Shoulder System, which commands a wide clinical audience in a rapidly growing market and the Nexel Total Elbow. Our growth prospects in the Foot and Ankle category are also extremely promising, including the Trabecular Metal Total Ankle, the Phoenix Ankle Arthrodesis Nail system, and the A.L.P.S. Total Foot Plating System. Backed by a broad portfolio of solutions, we'll bring heightened focus to this attractive market. For our focused trauma sales teams, immediate opportunities include the ePAK Single-Use Delivery System, featuring the DVR Crosslock Distal Radius Plate, as well as the Cable-Ready Cable Grip System. Our Surgical business also stands to benefit from the enhanced focus and sales force specialization we're leveraging to drive our broadened clinical portfolio. Zimmer Biomet also positions a diversified dental business offering critical scale to address the faster growing value-market segment with our line of PI branded offerings, in addition to our range of Encode custom abutments and a market-leading regenerative portfolio. Turning to our Spine category. As a combined company, we're building on a successful cadence of commercial releases from 2014. This global business offers a differentiated pipeline and a comprehensive portfolio that address minimally invasive procedures with our PathFinder NXT Pedicle Screw System, as well as lateral access surgeries with the Timberline Lateral Fusion System. Finally, we're very excited about our innovative and rapidly expanding craniomaxillofacial and thoracic businesses, as well as our opportunities to benefit from sales channel and expertise within the bone healing business. In support of our longer term growth targets, we’ll use our scale to enhance the differentiation of our innovation pipeline and to accelerate the pace of our future commercial introductions. With research and development resources that are nearly 80% greater than our standalone capability, we will aggressively pursue innovations to address unmet needs and create new market adjacencies to expand our leadership in musculoskeletal healthcare. With that, I'll turn it over to Dan, who will this continue this discussion in greater detail, as well as review our guidance. Dan?
Dan Florin:
Thank you, David. Good morning, everyone. It's a pleasure to be here with you today. I'm looking forward to serving our new company in the role of Chief Financial Officer and building upon the successes achieved by my predecessor, Jim Crines. First of all, I want to thank Jim for all of his support during this transition period, and I wish him the very best in his future endeavors. Today, I'm going to walk you through a brief summary of the synergies and accretions associated with our merger, followed by my comments on the prevailing market and pricing conditions and our 2015 guidance. As incoming CFO, I'm fully committed to maintaining the value creation principles, which have made Zimmer and Biomet leaders in musculoskeletal healthcare and which have formed the pillars to this deal namely, growth through innovation and outstanding service, operational excellence and prudent capital deployment. Accelerating our top line growth, as David has outlined, in combination with execution on our cost synergies and operational excellence plans will result in leveraged earnings growth and increase cash flows to both reinvest in growth initiatives and return capital to stockholders. Our fully staffed integration management teams are now hard at work, driving a disciplined global plan encompassing over 400 distinct projects across our commercial, functional and business units, with more than 7,000 relevant process milestones. Our new management team has significant merger integration experience, and we are leveraging many of the operating disciplines, playbooks and governance structures from Zimmer's successful acquisition of Centerpulse. Turning now to deal synergies. We continue to project net annual pre-tax operating earnings synergies of $135 million in the first year and $350 million by year three, post close. Recall that these net synergies are comprised of cost savings, somewhat offset by the EBIT impact of the product line divestitures and estimated revenue dis-synergies net of cross-selling benefits. We expect to realize the bulk of the cost synergies through the elimination of SG&A redundancies, as well as strategic sourcing and shared services initiatives, optimization of our manufacturing and distribution network and deployment of lean principles across the enterprise. Initial savings will be heavily weighted to the SG&A line on the P&L. We continue to expect adjusted earnings per share accretion in the range of $0.95 to $1.05 over the first 12 months post-closing, with approximately one-third of this number to be realized in 2015. As Bob noted at the beginning of the call, we have posted a presentation on our Investor Relations website that provides an explanation of our reporting changes, as well as selected combined pro forma historical sales results and financials. Within those schedules, we’ve provided a view of the past six quarters of constant currency revenue growth, based on our new product categories and geographic segments, which will be utilized beginning with our third quarter 2015 results. We've also included a reconciliation of Zimmer Biomet combined net sales to combined net sales to divestitures that were completed in order to finalize our merger. Lastly, we’ve provided a combined historical earnings statement from net sales to adjusted EBIT, including the adjusted margin analysis through the first quarter of 2015. We hope you find the pro forma information useful for your modeling. As you update your models, you'll note that there is a new sales category called SET, comprised of Surgical, Sports Medicine, Extremities, Foot & Ankle and Trauma with joint preservation technologies included in Sports Medicine. This product category comprises approximately $12 billion of the nearly $50 billion musculoskeletal market and is estimated to grow in the mid-single-digit range over the next few years. With the combination, the SET category now represents approximately 20% of our revenue base, and we're investing in growth drivers such as specialized sales forces and innovative products that compete aggressively in this space. As you'll see in the pro forma revenue schedules, for the first three quarters of 2014, Zimmer Biomet's combined quarterly revenue growth within the 3% to nearly 5% range, which we believe reflects at-or-above market performance during this period. Beginning in the fourth quarter of 2014 and continuing into 2015, combined growth rates began to decelerate to the 2% to 3% range, and eventually flat performance in Q2. We believe this reflects an absence of investment and offensive measures by our sales channels during the pendency period of the merger closing. With the merger now closed and our channel integration plans being executed, coupled with the strong portfolio and cross-sell opportunities that David outlined, we are optimistic that we will get back to at-or-above market growth rates as we progress through 2016. Turning to market and pricing conditions. We have seen ongoing but stable price pressure for the last several quarters. We believe the growth outlook for the global Knee and Hip markets will remain consistent throughout 2015 in the low-single-digit range. Procedural demand in our view, continues to be driven primarily by favorable demographics and growing utilization of musculoskeletal healthcare in emerging markets and under-penetrated developed markets. Moving now to our guidance. We are reaffirming our full-year 2015 pro forma revenue guidance of a constant currency growth rate of between 1.5% and 2%. As noted, the pro forma adjustments reflect the inclusion of Biomet revenues and the removal of revenue from the divested product lines for the comparable post-merger closing period in 2014. The impact from currency for the full-year is projected to decrease revenues by approximately 6%. Therefore reported revenue should be in a range of minus 4% to minus 4.5%, which in dollar terms is between $6.015 billion and $6.05 billion. We are also updating our full-year 2015 adjusted diluted earnings per share to be in a range of $6.65 to $6.80. Previously we had estimated full-year adjusted diluted earnings per share to be in a range of $6.60 and $6.80. It is important to note that the fully diluted average share count that should be used for the full-year diluted EPS calculation is estimated at 190.5 million shares, which includes shares issued to complete the transaction and does not assume any share repurchases. I'll now provide some details on guidance for the second half of 2015. We expect constant currency pro forma revenue growth on a day-rate basis to be between 1% and 2%. On an adjusted basis for the second half of 2015, we expect our gross margin to be in the range of 75% to 75.5%. We intend for our research and development expense to be in a range of 4.5% to 5% of sales. SG&A expense should be in a range of 38.5% to 39%. And adjusted net interest expense is expected to be $185 million. The adjusted effective tax rate is estimated to be between 26.5% and 27%. The fully diluted share count for the second half is approximately 206.5 million shares. Adjusted diluted earnings per share would be in a range of $3.45 and $3.60. Combining this range with the first half performance and applying the full-year diluted share-count of 190.5 million shares, you arrive at our full-year guidance of $6.65 to $6.80. For modeling purposes, please remember to reflect the expense to sales ratios and corresponding margins to account for the seasonality that occurs between the third and fourth quarters. Third quarter adjusted diluted earnings per share are projected to be in a range of $1.52 and $1.57. Finally, I want to provide a few comments on full-year cash flow. Cash flow from operations for the year is expected to be between $650 million and $700 million, which includes $430 million of costs related to the merger transaction and approximately $250 million of costs to realized synergies. We expect to spend approximately $500 million on instruments and property, plant and equipment in 2015, inclusive of approximately $60 million of integration-related items. Free cash flow, which we define as operating cash flow less cash outlays for instruments and PP&E is estimated to be between $150 million and $200 million. Please note that our guidance does not include any impact from potential business development activities or other unforeseen events. David, I'll now turn the call back over to you.
David Dvorak:
Thanks Dan. Zimmer Biomet now stands as one global leader. And with our increased scale in musculoskeletal diversification, we're able to anticipate and address the needs of the evolving global healthcare landscape. Our strategic vision continues to focus on delivering a compelling value proposition for patients, healthcare providers and our stockholders. And now, I'd like to ask Vince to begin the Q&A portion of our call.
Operator:
Thank you, sir. Ladies and gentlemen, we will now begin the question-and-answer session. [Operator Instructions] Analysts are allowed to ask one question and one follow-up question. One moment please for our first question. And our first question is from the line of Joanne Wuensch with BMO Capital Markets. Please go ahead.
Joanne Wuensch:
Thank you very much for taking my question. Since you're in the early stages of the integration, could you please walk us through a little bit of what you're experiencing that will help you or give you confidence that your growth rate will reaccelerate as we enter 2016?
David Dvorak:
Sure, Joanne. I think that the advantage that we’ve had of the long pendency period was we were able to develop extremely detailed methodical plans. And so when day one rolled around, our teams were extraordinarily well prepared, and that includes the plans that Dan outlined with respect to the different work streams and milestones that we're tracking. So we have a lot of details and capability to track and respond to anything that was not embedded in the plans. But with respect to the acceleration opportunities, the cross-sell is one of our primary areas of focus, and that opportunity starts with putting the right sales talent in place. I would tell you that that was a very pleasant surprise as we went through the experiencing of drawing out the best from both organizations. We have extraordinarily talented commercial leaders that had been appointed. And those individuals are putting their management teams and then sales rep appointments together. All of that work is expected to be substantially complete by the end of this year, and we're well on our way. Also we’ve been able to put in place all of the infrastructure necessary to facilitate the cross-sell opportunities. We had some opportunities to pre-build inventory in key product categories, to pre-train sales reps in key product categories, and so this offense is starting to ramp up. Clearly, that takes some time for that pipeline to rebuild and the momentum will be restored. And we're expecting to see terrific progress through the balance of the year that's going to set us up nicely for 2016 to get after those opportunities.
Joanne Wuensch:
And as my follow-up before I get to that, first I wanted to say thank you, Jim. It's been a pleasure to work with you. But the second question is, your guidance you called out, it does not include any potential business development. Should we think of you now that the deal has closed, as still looking or in a pause mode until you fully incorporate it? Thank you.
Jim Crines:
Let me just say thanks, Joanne. As I said, I very much appreciate working with you and the rest of the analyst community, but I'll let Dan respond to the question on capital deployment.
Dan Florin:
Great. Thanks Joanne for the question. Certainly we continued to be very active evaluating business development activities. We have a terrific business development organization, always looking for opportunities to drive growth. And we feel having leverage of about 4x that Jim described is not an impediment to that. We'll continue to be disciplined in terms of capital allocation. Zimmer has an excellent track record of being disciplined, and will continue to do so as we progress. But we'll continue to look for tuck-in opportunities, M& A activities. We believe strongly the cash flow generation of the combined enterprise, provides us the opportunity to do that, while we look to delever the balance sheet, grow EBITDA and reinvest in growth initiatives organically as well.
Joanne Wuensch:
Thank you.
Operator:
Thank you. Our next question is from the line of Bob Hopkins with Bank of America/Merrill Lynch.
Bob Hopkins:
Thanks, and good morning, and also good luck to Jim in your future endeavors. So thanks for taking the questions. I've got just two. I want to focus on revenues. Obviously one of the reasons why the stock has lagged a little bit is concern about revenue growth. So my first question is, can you talk a little bit about why you had to lower revenue growth guidance at the time of the deal close? And do you think that the level of dis-synergies that you originally thought about and talked about might now be higher than you originally thought? That's my first question. Thank you.
David Dvorak:
Sure. Bob, I think that it was clear that the pendency period was more extended than we originally anticipated. And naturally with the lack of clarity during that prolonged period of 14 months, you're going to lose some of that offensive momentum. All of that is very addressable. And the plans that we have in place with the appointments of the leadership, as I said, the infrastructural implementation and cascading that through the field organization puts us in a great place to restore that momentum as we work through the balance of the year. So I think it's more just the extended pendency period rather than anything at all fundamental changing. That's very temporary in the scheme of the underlying strategy for this combination, and we're quite confident that that's going to get addressed, so nothing fundamental whatsoever has changed by virtue of that.
Bob Hopkins:
So your thoughts on dis-synergies are not different than they were originally?
David Dvorak:
Not at all.
Bob Hopkins:
Okay. And then secondly, I just wanted to ask you to try to be very clear. I want to be clear about what you’re saying about 2016. So I think you said that you expect accelerating growth over the course of the year, but when do you think you can get back to market levels of revenue growth? And what specifically will drive the improved growth outlook as you look into 2016, especially when you consider things like U.S, knees right now still struggling in the negative 3% to 4% territories? I just want to be as specific as we can about what the drivers are in 2016 that will improve growth?
David Dvorak:
Well, just to clarify, to start with Knees are at-or-slightly above market on the legacy Zimmer side. I think that holds true for the legacy Biomet side also. The Hip category requires some attention, but I think with the complementary aspects of the portfolios, we’re going to be able to bring that attention to it and put that on a better course, Bob. But if you think about the dynamics that are going to go into what we generate by way of top line growth, you have the circumstances that you described coming into the closing, the opportunities that I'm outlining this morning to reaccelerate the top line growth and these are businesses that going back just to the point of announcement through the majority of 2014 together were generating 3% to 5% growth. And so that quite clearly is an opportunity for these businesses. And that's on a standalone basis. So you put these portfolios together, pick the best of the best in sales leaders, train up the sales reps for those opportunities, leverage the relationships that exist at the surgeon level for cross-selling and that's going to be extraordinarily powerful. And that's not a temporary synergy by virtue of the combination. That's going to be a sustainable synergy. And we'll talk a little bit more I suspect, before we're done with the Q&A about the product portfolio and the go-forward pipeline opportunities. So if you look at the restoration of that momentum, as I said, speed is important but getting it right in the field integration, the plans that we have allow us to do both. By the end of this year, we're going to have the right sales team set up and at a full clip going into 2016. And so then what has to happen is that momentum has to be restored and the cross-sell opportunities have to be ramping up to a point where they're offsetting any of the natural fallout as far as dis-synergies go on the top line. That's going to occur sequentially. We’re going to see improvement throughout 2016. And so the comment that I would make to you by a way of answer is, tough at this point to pinpoint the particular month, but you’re going to see sequential improvement throughout 2016. And we're confident that we're going to get back to or even above market growth rates as the year progresses.
Bob Hopkins:
Great. Thank you.
David Dvorak:
You’re welcome.
Operator:
Thank you. Our next question is from the line of Mike Weinstein with JPMorgan. Please go ahead.
Mike Weinstein:
Good morning, and thanks for taking the question guys. And Jim, obviously we've known each other a long time, so it's been fantastic working with you. I do want to start just on the combination of the sales organizations. And David, we had talked prior to the close about getting some better visibility on your plans for combining the distributors and sales reps and what that might start to look like. So can you, A, start to maybe talk a bit about that today in terms of where you are in that process? And B, can you talk about retention. Have you lost any notable distributors in the U.S. or what your rep retention looks like? And then C, what you're doing financially to try and get people to stay? Thanks.
David Dvorak:
Sure, Mike. To start with an overview of the structure, this is an organization that will be led by the best of the best. If one looks at the legacy leaders across the globe, I think a lot of times these discussions end up becoming focused immediately on United States market, but across the globe, we're selecting the best territory managers, the best country managers, the best sales managers supporting those level leaders. And then as we said from the beginning retaining the sales rep positions. This is a really powerful organization in the thousands of numbers, and numbers at the sales rep level and it provides us with an extraordinary opportunity to develop more specialized sales forces in the non-large joint areas, which is something that we'll begin implementing through this integration process and continue to grow in the years to come. So we’re well on our way, Mike. Those leadership positions obviously at the executive level and the next couple of levels down within the organization were all appointed pre-close and well before pre-close. So they were able to put their plans together next level down. And all of those execution plans are cascading down to the rep level as we speak. As I said, for the amount of work to be done and the size of that channel to do that in the coming several months and be locked down going in 2016 is a big task, but it's the right priority for the organization. And with those appointments is going to come certainty and clarity, so that people are going to be very offensive minded and began to start to take advantage of the cross-sell opportunities that exists, both at the product and at the surgeon level. The compensation opportunities are terrific. There isn't a better bag in the industry. And irrespective of product category area of focus, these sales reps are going to have wonderful opportunities, not only with the product category bag that exists at this point, but the pipeline that exists, and then the opportunities for greater differentiation on the R&D side, because the scale that we have across the entire portfolio. So people are excited about it. The tone is very positive. I would also tell you that these are leaders that have, in many cases, 10, 20, 30 years of experience. So these transitions are not new to them. They have a lot of experience in just managing the channel. I'd also tell you, Mike, that when you look at these leaders that are chosen on average in the United States for example, the selected leaders have a compounded annual growth rate that's hundreds of basis points above those that are not selected at that level of the organization. And so this is the best of the best. They know how to put these organizations together and run that offense, and we're going to be hitting our stride in short order.
Mike Weinstein:
So let me circle back to David. So can you just tell us the picture you're setting first off, is one where you’re consolidating sales management and then leaving the reps and distributors in place. Can you talk about retention at this point and what that looks like, and what you expect that to look like, and how long you're financial incentivizing people to stick around, so we can get a sense of kind of what the window of risk looks like?
David Dvorak:
Yes, I think that the retention has been excellent. These attrition rates have been quite consistent with historic levels. It may tick up single-digit percentage points as we go through this process, and this is what we would expect to continue to see, but I don't it going beyond that. And the leadership appointments down to the management level in the field will be taking place very early on, and in many instances, have already been accomplished in different territories and will be done at the sales rep level as these months progress. So I don't anticipate any significant uptick in attrition rates, Mike.
Mike Weinstein:
Okay. Thank you, David. I'll let some others jump in.
David Dvorak:
Sure.
Operator:
Thank you. Our next question comes from the line of Matt Taylor with Barclays Capital. Please go ahead.
Unidentified Analyst:
Hi, this is actually Young Li [ph] in for Matt Taylor. Thanks for taking our questions. The first question is, I guess, actually maybe on M&A. It's a question on robotics. So one of your competitors reported pretty good robot sales this quarter and there is interest in medical robots among other companies in med tech. Just wondering if you can talk about your level of interest in this area?
David Dvorak:
Well, we're very interested in the underlying premise to those technologies and we’ve been added for a long time with both internal/external development efforts in that regard. Our portfolio of patient-specific instruments including legacy Biomet Signature technology, preoperative planning systems and templating systems, our iASSIST technology, our eLIBRA technology are all consistent with the goal of making these procedures as reproducible and heightening the outcomes in a very cost effective way. That's been the mission that we've been on for many years and we've made terrific progress and feel good about where our programs are going to take us in that regard. To the extent that technologies can achieve those same objectives, preferably that are smaller, faster, cheaper, preferably ones that integrate into the natural workflow for the surgeon and drive OR efficiencies as opposed to affecting some of those key areas in a negative way, then we'd be interested in any other technologies. And so, we're going to continue to be very open-minded, but we like the portfolio of technologies that we've been developing, and what we have underway to continue to progress in that area.
Unidentified Analyst:
Okay, thanks. And regarding the CMS proposal to bundle hip and knee reimbursements, it's been talked about a lot before, but can you just remind us what your expectations are in terms of impact on price and if you're working with payors to maybe mitigate some of that impact?
David Dvorak:
I don't see that is having any significant impact on price. I think that the pricing environment that we’ve been operating in has all of the drivers embedded in it that are the underlying reasons for that proposal. I think that the proposal in many ways, as well as the delivery modifications that are embedded within the ACA in general are consistent with what we all have to be mindful of. Again, we're trying to develop deeper partnerships with our customers, the surgeons and providers to bring about a better patient outcome in a cost efficient way, and that more expansive end-to-end definition that's embedded within that proposal is the right concept. There are elements of that proposal that should be modified. We ought to make sure that we're not stinting healthcare, especially when the delivery of healthcare and access, especially when you look at the measurement period on the back end of 90 days. These are procedures that are often times appropriately measured in years as far as success rates. And so we should be careful about how we set those proof [ph] programs up, but the concept of ensuring that the cure is coordinated in a patient-centric way and is mindful of the overall cost is an appropriate one from our perspectives. The innovations that we have underway and the opportunities that we have with our field service organizations to contribute positively to that endeavor are immense, and it's a big part of our strategy going forward. So I think it's in alignment with how we ought to be thinking about improving patient care in general, and I don't see it having any impact of significance on the pricing environment
Unidentified Analyst:
Very great. That's very helpful. Thank you.
David Dvorak:
You’re welcome.
Operator:
Thank you. Our next question is from the line of David Lewis with Morgan Stanley. Please go ahead.
David Lewis:
Good morning. Just one historical question for Dave or Dan. I guess, the stated objective when you did the deal for the balance sheet was debt repayment, and now we have a situation where what I'm hearing is your conviction in long-term deal accretion is actually higher post-initial announcement. Dave, you mentioned this morning that the dis-synergy investments were unchanged, yet obviously as you know, the stock is lower. So I guess the question is for Dan or for David. Why does aggressive share repurchase now not make more sense than aggressive debt repayment?
Dan Florin:
David, this is Dan. As we progress through the rest of 2015 and continue to gain traction on integration and confidence in the execution of that integration, which we do have full confidence in, we'll continue to evaluate capital deployment. So certainly to drive the integration and the synergies, we need to spend some cash to do that. There is a nice return on that investment. As per my earlier comments, you look back at a track record of Zimmer in terms of capital allocation. It's a terrific track record, returning nearly 70% of free cash flow to stockholders in the form of dividends and share repurchases. So going forward, we're focused on executing the synergy program, accelerating the top line growth, driving improvements in our free cash flow yields back to historical levels. We see that type of opportunity. With that enhanced cash flow generation, we'll continue to look at what makes sense on a go-forward basis. So we'll go through a detailed operating plan for 2016, look at cash needs and weigh those trade-offs. So it's certainly something that we'll continue to evaluate. We'll also over time look at a deliberate attempt to delever the balance sheet. We have been able through this inter-company loan transaction that the tax team executed has opened up that pipeline to OUS cash, so that's been a critical initiative that's behind us. The access to that cash begins late this year. So at that point in time, we'll have cash available to make those decisions. And then out over time, as we build free cash flow, have access to that OUS cash, I think that gives us a lot of flexibility to look at both organic growth capital, if you will, external opportunities and then return of capital to stockholders.
David Lewis:
Okay. That's very helpful, Dan. I guess the other second question I have is just revenue trend as you described have obviously lagged, but margins have trended much better. So where are you seeing primary success that's driving that underlying performance? And as you go through the integration, how confident are you that we see a continuation of these up margin trends? Thank you.
Dan Florin:
Sure. Certainly as we’ve progressed through the integration plans and we start to realize those synergies, keep in mind there will be a ramp up of those synergies over time. As you see in our second quarter performance, the gross margin rate is benefiting from the gains on the foreign exchange contracts. And keep in mind that as we bring Biomet into the fold and start layering the Biomet cash flows into the Zimmer hedging program, that will take time to gain traction. So in the back half of 2015, while the hedge contracts will continue to contribute in a relatively consistent basis from a dollar standpoint as we bring the Biomet revenues into that as a percentage of sales, the contribution of the FX gains will be lower. So that does put some pressure, if you will, on the second half gross margin rate relative to the first half and that's embedded in the guidance that I just provided. But the underlying ability to drive operating margin improvement is real by virtue of the synergy plans that we have. And importantly, the mix benefits of premium technologies on the Biomet side as we continue to drive growth there. So the cross-sell opportunities - a number of those cross-sell opportunities are focused in the premium technologies that the Biomet portfolio brings to bear day one.
David Lewis:
Thank you very much.
Dan Florin:
You’re welcome.
Operator:
Thank you. Our next question is from the line of Larry Biegelsen with Wells Fargo Securities. Please go ahead.
Craig Bijou:
Hi guys, it's actually Craig on for Larry. Thanks for taking the questions. I have a couple of questions on EPS, and just starting with 2016 EPS. I think on the last call, you mentioned that we could see 15% to 20% growth on 2015 EPS. So firstly, are you still comfortable with that range? And second, is the accelerating top line growth, could that potentially lead to upside to 2016 EPS growth?
Dan Florin:
Craig, this is Dan. Certainly based upon everything that I’ve seen and analyzed to-date, including the details of our synergy and integration program, I am confident that we can deliver earnings per share within that range, a range of $6.65 to $6.80. I'm confident in that regard. With respect to the top line, the opportunities that David has outlined, in terms of the acceleration of growth through 2016, is embedded within that assumption. So yes, at this point in time, we’re confident in the ability to deliver that EPS growth in 2016.
Craig Bijou:
Okay, thanks. And then just as a quick follow-up. When you think about EPS growth beyond 2016, I know in the last call, I think Jim mentioned that the 8% to 10% management goal for EPS growth. And I wanted to ask looking out in 2017, 2018 are the synergy - I guess, are the synergies necessary to hit that 8% to 10% growth, or could the synergies from the deal be incremental to the 8% to 10%?
Dan Florin:
Sure. So later this year - first with respect to 2016, we'll be providing official guidance in January for 2016. So our stated goal of confidence in that EPS growth is what we're shooting for, our operating plan will be geared towards the achievement of that. And then in January, we'll give you the official guidance for 2006 team. At the same time, in the upcoming months, the new management team will be going through the strategic planning process looking out beyond 2016. And certainly as we think about EPS opportunity at the combined enterprise of the 8% to 10% type range, we feel confident based on what we know right now of the combined portfolio that we can deliver in that range. And as we go through the strategic planning process, we'll look for opportunities to exceed that. But at this point in time, I'd say we're comfortable in that range. And as we talked about 2016 guidance in January, we can give you an update on our thinking longer term.
Craig Bijou:
Great. Thanks for taking the questions.
Operator:
Thank you. Our next question comes from the line of David Roman with Goldman Sachs. Please go ahead.
David Roman:
Thank you, and good morning, everybody. I know there aren’t a lot of questions on the deal, so I was hoping to ask a couple of questions on the underlying businesses. Maybe you could, David or Dan, give us a little bit more color on what's going on in both the Trauma and Dental businesses? And maybe Trauma and Extremities more specifically, given that those are end-markets that look to be growing quite a bit faster than the growth you're generating right now, and any factors that maybe influencing the trends in your business and any product launches that could be drivers of an uptick on a go-forward basis?
David Dvorak:
Sure. I think that the Trauma business - I think we have significant opportunities in that regard, David. When you look at the complementary aspects of that portfolio, we immediately gravitate towards a couple of the key areas. The Distal Radius product category is one that we have not had much of a presence in on the Zimmer side historically. The product offering is first rate on the Biomet side. The Cable-Ready System is strong on the Zimmer side. That's a big cross-sell opportunity into that pipeline. Also, sales force specialization is going to be meaningful. We've got a channel that historically has been more oriented toward the large joint side of the business and we're going to be breaking out sales rep specialization to bring greater emphasis. So you've got more emphasis at the sales rep level, a more comprehensive portfolio that puts us in a position to compete very effectively in level-1 level trauma centers, where we haven't had as much of a presence [Technical Difficulty], and that's going to add up to a big opportunity to expand our market share. So that's a good example of what this deal brings into these smaller business categories for us where we had subscale businesses, and now are sort of in a sweet spot where we have critical mass, a broad portfolio are in a very competitive position and are very confident that we're going to be in a share gain mode. And I would say the same thing about Dental. You're essentially doubling the size of those product categories by virtue of this combination. And so our capability to do well at the premium, as well as the value level within the dental market across the globe is greatly enhanced by this combination. And then you add some other areas including the legacy Zimmer dental regenerative portfolio, which is an industry-leading portfolio that the legacy Biomet reps are going to be able to sell into. So great opportunities in both, and I think you're going to start to see some of the benefits as we progress through 2016 in those categories.
David Roman:
That's helpful, thank you. Then maybe a follow-up on one of your prepared comments. I believe in your prepared remarks you said that the opportunity to sort of invest in innovation would increase by about 70%. That sounds like just adding the Biomet R&D to the existing base Zimmer R&D, but over time, are there opportunities to see leverage on that line given that there might be some duplicative efforts within the two companies and sort of quote R&D synergies and are those included at all in the $350 million number?
Dan Florin:
Yes, the number was in that range. It was 80%. And it is - the math that you describe, as far as the measure by dollars that the capabilities are obviously diverse. It's between these organizations. So there is a positive impact in that regard. There is opportunity to repurpose those resources, and from our perspective go after a more differentiated research and development portfolio, both with internal and external development focused on the musculoskeletal space. And that's logical relative to the portfolios that we're bringing together and the need to continue to maintain the vitality of those go-forward systems, but to be able to invest in some higher risk, higher reward differentiated projects. At the same time, they're going to be very directly in addressing the unmet needs and getting after some of the opportunities to improve care and address the cost challenges that the customers face. So that's really exciting to us. I would tell you that it is not an area where we’re looking to pull down our spend. So it is indeed to be a targeted area for expense synergy, if anything, I think that we're going to see big opportunities and potentially to expand our commitment in the research and development areas in absolute dollar spend in the coming years.
David Roman:
Got it. I appreciate all the perspective. And Jim, best of luck in your future endeavors.
Jim Crines:
Thank you.
Operator:
Thank you. Our next question is from the line of Richard Newitter with Leerink Partners. Please go ahead.
Richard Newitter:
Hi. Thanks for taking the questions. And good luck to you, Jim. I was hoping that you could talk a little bit more about the SET business. I think that was something you said was now 20% of your revenue base that you see having potential to grow in the mid-single-digit range. Just wondering if you’d go over some of the opportunities there. The faster growing products or the product areas you're most excited about and how long you think - is that an area where you think you could maybe get acceleration faster than some of the other areas of your business, or is that the right way to think about it? Thanks.
David Dvorak:
Sure. We are extraordinarily excited about the opportunities within that subset of the business. These are faster growing markets. And as I was describing earlier, these are markets that you can generally characterize as being ones where we've had businesses that have had some scale challenges historically. And those scale challenges create some headwinds both in commitments that you can make from an R&D spend, as well as the sales force build out, medical training education, other important ingredients to running these businesses successfully, and to do that in a profitable way and a value creating way from a stockholder perspective. So they really validate a major premise to this combination of the first instance. And I think you're going to see our performance in a direction that's consistent with that. I would tell you that I think that there are some big immediate opportunities in that cross-sell list, but those are consistent in the large joint areas too. So I don't think that they're differentiated in that regard. Good examples and opportunities across every one of the product categories is just that SET bunch of businesses have that - have the advantage of getting to scale, have the advantage of enhance sales force specialization being built into our plans, and reinvestment in that regard. And they're also operating in traditionally faster growing markets to begin with. So when you add all that up, we see that 20% portion of our business being very augmented to - and enhancer to our top line growth rates. So that mid-single-digit growth rate is sort of a short-term perspective, as to where we expect that business to get to. I would tell you that our aspiration is to drive it much, much higher than that.
Richard Newitter:
Thanks. And maybe just one follow-up for Dan. As you think about the sequential growth acceleration trajectory that you laid out for ‘16, can you tell me, what’s your implied assumption there on pricing trends for the year ahead? Do you assume it doesn't get any worse than where we are today, or are you embedding some incremental cushion for more - further erosion from where we stand today, and do you still think you can do sequential growth acceleration moving through the year in that situation?
Dan Florin:
We've seen, as we discussed, very stable rate of decline on pricing over the past three or four quarters. Our assumption, as we look out to 2016 is consistent with that assumption, based on what we've seen. And so at this point in time, we're not assuming any break in trends from that perspective.
David Dvorak:
Vince, we have time for one additional question.
Operator:
Thank you, sir. Our last question comes from the line of William Plovanic with Canaccord Genuity. Please go ahead.
William Plovanic:
Great. Thanks. Good morning, and thanks for taking my question. The first is just to go back on distribution. What are you doing specifically with the overlapping territories at the rep level? Are you retaining reps, are you repurposing them for Extremities? I’m kind of - you've made a lot of comments in general [ph]. I'm just wondering if we could get some specifics from you, and then I have a follow-up. Thanks.
David Dvorak:
Yes. Just to reiterate, William, we're retaining reps. There are too many opportunities by virtue of this combination from a product portfolio standpoint to be able to afford to lose good reps, so we're retaining the reps. And look, we're looking to leverage their strengths and the product portfolio strengths in the best way possible. And that means what they've done well historically is what we would continue to want see them leverage. And areas where they've done less well, we're going to look to augment. And so there are going to be opportunities for enhanced specialization, as all of that is designated, but we're going to make intelligent decisions driven by the people that are closest to the facts and circumstances that allow them to make informed judgments about that. But the tone is very, very upbeat among the sales force. They see the opportunity and I think fundamentally know that this isn't just a temporary opportunity on the front-end but rather that what we're able to build into the future and the pipeline and solutions that we're going to be able to lever is going to be a differentiated set and a comprehensive set. So that bodes very well for the success that we’re looking to have in those conversations as we complete this integration by the end of the year on the commercial side.
William Plovanic:
Okay. And then just, now that the merger is finally complete. Are there any assets that you view is really not core to the combined company?
David Dvorak:
We see opportunities for all these assets to contribute to value creation at this point in time. And that doesn't mean that we're going to be overly rigid and cease to evaluate portfolio decisions going forward. It's about value creation. At this stage, our expectation is that all these assets are going to contribute and we're going to work real hard to help the leaders make those contributions. And to the extent that that view changes at some point in time, then we're going to make the decisions in the best interest of the stockholders that now we're really enthusiastic about the opportunities and synergies, by virtue of this portfolio coming together. We think that there is a real strategic advantage to the musculoskeletal focus that we have from an R&D standpoint, from an operations standpoint, from a go-to-market strategy standpoint. If anything, the evolving healthcare market is going to make that more important. And we think that we can be more impactful in helping shape those solutions going forward by virtue of these assets.
William Plovanic:
Okay. And then, Jim, just thanks for all of your support over the years. I appreciate it. Thank you.
David Dvorak:
Great. So I'd like to thank everyone for joining the call today and for your continued interest and support for Zimmer Biomet. We look forward to speaking with you on the third quarter conference call, which is scheduled for 8:00 AM on October 29 later on this year. With that, I'll turn the call back to you, Vince.
Operator:
Thank you, sir. Ladies and gentlemen, thank you again for participating in today's conference call. You may now disconnect.
Executives:
Robert J. Marshall - VP, Investor Relations and Treasurer David C. Dvorak - President and Chief Executive Officer James T. Crines – EVP of Finance and Chief Financial Officer
Analysts:
Robert A. Hopkins - Bank of America Merrill Lynch Matthew C. Taylor - Barclays Capital Inc. Michael Weinstein - J.P. Morgan Chase Glenn J. Novarro - RBC Capital Markets Richard S. Newitter - Leerink Partners, LLC David H. Roman - Goldman Sachs & Co. William J. Plovanic - Canaccord Genuity David R. Lewis - Morgan Stanley & Co. LLC Lawrence H. Biegelsen - Wells Fargo Securities, LLC Craig W. Bijou - Wells Fargo Securities, LLC
Operator:
Good morning, I would like to turn the call over to Bob Marshall, Vice President, Investor Relations and Treasurer. Mr. Marshall you may begin your call.
Robert J. Marshall:
Thank you Julie. Good morning and welcome to Zimmer’s Q1 2015 earnings conference call. I'm here with our CEO David Dvorak and our CFO Jim Crines. As a reminder our earnings release and related financial information is available on our investor relations website at investor.zimmer.com. A replay of this call will also be made available on our website. Before we start, I would like to remind you that our discussions during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties. Also, the discussions during this call will include certain non-GAAP financial measures. Reconciliations of these measures to the most directly comparable GAAP financial measures are included within the earnings release, which is available on our web site. Additionally all sales variances will be stated on a constant currency day-rate growth basis. The results in the company’s earnings release this morning reflect constant currency growth rate including the extra billing days in the first quarter of 2015 that resulted from the change in our interim quarter end closing convention for the majority of our international reporting unit from March 25 to March 31 that’s referenced on our previous earnings call. With that, I'll now turn the call over to David Dvorak. David.
David C. Dvorak:
Thank you, Bob and good morning, everyone. Before I review our first quarter financial results I would like to take a few moments to share our vision for the future of Zimmer Biomet. I’ll then discuss our first quarter performance and Jim will provide further financial details. As Bob has just noted I’ll state all sales variances on a constant currency day-rate basis and all earnings results on an adjusted basis. During the first quarter we were pleased to announce that the European Commission and the Japan Fair Trade Commission granted clearance of Zimmer’s planned combination with Biomet. We now expect to close the transaction during the month of May as we work towards clearance from the U.S. Federal Trade Commission. If we've communicated previously the rationale behind this merger has always been about enhanced scale and the opportunity to accelerate the pace of innovation across our musculoskeletal portfolio. We think that in the wake of this historic combination we’ll be well positioned to capitalize on future growth opportunities. Zimmer Biomet’s comprehensive and diversified portfolio of musculoskeletal conditions will offer more scalable and predictable revenues as well as immediate cross selling opportunities. Our enhanced scale and broadened product portfolio will also enable us to enter exciting new products categories such as sports medicine as well as continuing to expand our participation in key emerging markets around the globe. There are also a number of financial and operational synergies connected with this transaction that are highly consistent with Zimmer’s longstanding value creation framework. Moreover, we're confident in the organization’s ability to execute effectively on a combined basis following the closure of the deal creating and returning value to our stockholders over the long-term. Against the backdrop of these transformational changes, we remain a company fuelled by innovation and driven by our passion to restore mobility, alleviate pain and improve quality of life for patients around the world. Our combined research and development teams will leverage our enhanced resources to efficiently and cost effectively bring the new generation of musculoskeletal technologies and broad clinical solutions to market. Turning now to our performance. In the first quarter, Zimmer continued to produce steady sales growth in several geographies and product categories while meeting our financial commitment and delivering expanded operating margin leverage. Consolidated net sales for the first quarter were $1.13 billion, an increase of 1.7% and our earnings per share were $1.58 a decrease of 1.3% from the prior year period. Our sales increased by 1.3% in the Americas, by 2.1% in Europe, Middle East and Africa region, and our Asia Pacific business delivered 2.6% growth over the prior year period. In the first quarter, we saw global musculoskeletal markets continue to demonstrate stability consistent with trends in the previous two years. Zimmer experienced a price decline of 2.2% in the quarter which was consistent with our expectations coming into the year. Turning to our product categories, first quarter sales for our leading knee business increased by solid 3.9% reflecting positive volume and mix of 6.7% and negative price of 2.8%. Our Americas segment reported a sales increase of 4.3% while the Asia-Pacific region delivered 4.1% growth and our Europe, Middle East and Africa business grew by 2.8% over the prior year period. The quarter was marked by steady gains for Persona, the personalized knee system, which we continue to successfully position in concert with our advanced intelligent instrument offerings including iASSIST, the personalized guidance system, patient specific instruments, and the eLIBRA soft tissue balancing system. We’ll continue to broaden and differentiate our knee portfolio including our growing line of early intervention solutions along with a continuum of care such as our Gel-One cross link Hyaluronate treatment and our expanded Zimmer knee creation Subchondroplasty offering. It is also important to note that this year marks the 20th anniversary of our leading next gen knee replacement system with more than 5 million implantations completed to-date. Patients around the world continue to benefit from the safe joint flexion and restored natural kinematics that the next gen system offers. Just as next gen marked a major step forward for total knee replacement two decades ago, we intend to continue setting the pace for innovation in the years ahead. Turing to Zimmer’s hip business, sales decreased by 0.6% in the quarter reflecting positive volume and mix of 2.1% and negative price of 2.7%. These results include a sales increase of 1.3% in Asia-Pacific, 1.4% increase in Europe, Middle East and Africa, and 3.2% decrease in the Americas. As we focus our U.S. execution in the quarters ahead, we expect that premium constructs will continue to drive penetration and deliver improved growth. These offerings include the Continuum Acetabular system which leverages platform Zimmer technologies such as Trabecular Metal material and our Vivacit-E vitamin E-infused bearing material, which recently completed 100 million cycles of wear testing and continues to demonstrate ultralow wear properties. And notably, since receiving regulatory clearance in several European markets last November, the Synovasure diagnostic test for periprosthetic joint infection has already delivered promising early sales results. In extremities, Zimmer recorded growth of 3.1% in the first quarter. Our sales for this business continue to be driven by the performance of our Trabecular Metal reverse shoulder, which now features our platform Vivacit-E advanced bearing material. We also continued our growth into anatomical adjacencies with premium solutions. The Trabecular Metal total ankle system continues to perform well and the Nexel Total Elbow is attracting a growing number of surgeons seeking the clinical advantages of Vivacit-E. Zimmer dental sales decreased by 5.7% in the first quarter. A stable performance in the U.S. was offset by challenging sales comparisons in the Asia Pacific region owing to stocking patterns of our distributor network in Japan and accelerated growth of the China market in the prior year period. However we continue to gain traction with our value based offerings designed in the PI Branemark philosophy in key European markets. Looking forward we will continue to focus our execution behind building sales of our market leading dental regenitive portfolio as well as our premium Trabecular Metal dental implants, Zimmer Trauma grew sales by 3.4% in the first quarter, we continue to achieve steady sales results from our differentiated trauma portfolio including sales of the Zimmer Natural Nail family and the Zimmer NCB Periprosthetic Locking Plating System. Trauma is a particularly exciting opportunity concerning our pending combination with Biomet, as we seek to leverage our enhanced resources to accelerate the development of proprietary innovation that are clinically and economically relevant for the global trauma market. Zimmer Spine delivered solid 5.4% growth over the prior year period building on the success commercialization of a dozen new solutions in 2014 including the Virage OCT Spinal Fixation System, Optio-C Anterior Cervical System and our expanded line of Puros Demineralized Bone Matrix grafting solutions. These innovative new offerings are driving growth and enhancing the diversification and competitiveness of our signed portfolio as we execute on our broadened portfolio we will continue to advance proven strategies and sustain our focus on promising market adjacencies such as minimally invasive surgeries. Zimmer Surgical and other sales were flat in the first quarter and included a solid performance by our surgical power tools in the Asia Pacific region and bone cement products in certain European markets. We also achieve steady growth in our wounded solutions particularly in the United States. As we move forward and away from challenging sales comparisons in the prior operating periods we will continue to grow our presence in the operating room suite through the expansion of these and other clinically relevant solutions that meet the needs of our surgical customers. With that I will now ask Jim to provide further details on the first quarter and our updated guidance. Jim?
James T. Crines:
Thank you, David. This morning I will review our first quarter performance in more detail and then provide additional information related to our standalone earnings guidance as well as anticipated accretion and synergies connected with the pending merger with Biomet. Total revenues for the first quarter were $1.13 billion an increase of 1.7% on a constant currency day rate basis when compared to the first quarter of 2014, net currency impact for the quarter decreased revenues by 6.8% or $80 million, our adjusted growth profit margin was 75.8% for the quarter favorable to prior year by 90 basis points after adjusting for non-cash amortization expense. Foreign currency hedge gains together with favorable mix of products in geographic revenues and cost savings from our operational excellence initiatives were offset in part by higher excess in obsolescence charges and the impact of negative price. The company’s R&D expense increased 2.2% or $1 million on a quarter basis to 4.3% of net sales when compared to the prior year. Selling, general and administrative expenses were $425 million in the first quarter and 37.5% of sales with 80 basis points below the prior year quarter after adjusting for non-cash amortization expense. The company continues to make strides in driving efficiencies throughout its operating units in administrative as well as commercial functions. In the quarter, the company recorded pre-tax charges of $87 million in special items and $3.9 million and cost of products sold pertaining to global restructuring, quality and operational excellence initiatives, and recent acquisition. The company also recorded $20.4 million in non-cash amortization charges during the quarter, adjusted first quarter 2015 figures in the earnings release exclude the impact of these charges. Adjusted operating profit in the quarter amounted to $386.2 million at 34% our adjusted operating profit to sales ratio is 150 basis points higher than the prior year first quarter after adjusting for non-cash amortization expense. This marks the seventh consecutive quarter of year-over-year operating margin improvement reflecting the ongoing progress we’ve made with our operational excellence programs as well as a positive impact of hedge gains and mixed benefits associated with the number of new products introductions across our broad portfolio of musculoskeletal solutions. Adjusted net interest expense for the quarter amounted to $12 million, which was flat when compared to the prior year quarter. This excludes $28 million of acquisition related finance charges, adjusted net earnings worth $272.8 million for the first quarter, a decrease of 0.6% when compared to the prior year. Adjusted diluted earnings per share decreased 1.3% to a dollar and $1.58 on 172.9 million average outstanding diluted shares. Our adjusted effective tax rate for the quarter was 26.6% and was 200 basis points higher when compared to prior year, due principally to the impact of foreign currency translation on foreign source earning as well as the exclusion of non-cash expenses in adjusted earnings. Our reported effective tax rate in the quarter was 23.7% at $1.2 reported diluted earnings per share decreased 20.9% for the prior year first quarter repeated EPS of $1.29. Operating cash flow for the quarter amounted to $92 million, a decrease of 52% from $188.8 million in the first quarter of 2014. The decrease was driven primarily by the settlement of a pre-issuance hedge associated with our recently completed senior notes offering. Those inventories were $1.2 billion at the end of the first quarter, an increase of $48 billion from December 31, 2014. As I have noted on previous calls, the increase is due primarily to the support of ongoing commercialization of new product offerings as well as the affects of placing more inventory into distributor hospital consignments. Adjusted inventory days on hand finished the quarter at 389 days as compared to 334 days at the prior year quarter end. As of the end of the first quarter, net receivables increased $869.8 million from $939.1 million in the first quarter of 2014 or 7% lower than in the prior year. Our adjusted trade accounts receivable days sales outstanding finished the quarter at 64 days, one day improved when compared with the prior year. Depreciation and amortization expense for the quarter amounted to $89 million. Free cash flow in the first quarter was a net outflow of $9.3 million; $113.3 million lower than the first quarter of 2014. We define free cash flow as operating cash flow less cash outlays for instruments and property, plant, and equipment. The decrease in free cash flow was driven by lower operating cash flows as I’ve just noted as well as our continuous investment in support of the ongoing large of new products through increased instrument deployments as we expand commercialization of newer products globally. Capital expenditures for the quarter totaled $96.8 million, including $62.4 million for instruments and $34.4 million from property, plant, and equipment. I would now like to make a fuel remarks regarding guidance. As indicated in our release, we anticipate closing the pending Biomet transaction in the month of May. Upon closing, we will provide additional details regarding our expected full-year performance inclusive of Zimmer standalone and in combination with Biomet for the balance of the year. As such, I will provide a few updates to the numbers I have previously communicated. Before returning to the financial guidance specifically, I want to reiterate the company’s perspective on the market and general pricing dynamics. We continue to view the global knee and hip markets, the growing in low single digits for the full year, market growth drivers including the ageing of the global population, positive outcomes associated with joint replacements and other musculoskeletal procedures, and increasing utilization in emerging markets resulting in consistent trends in procedure demand in our view. We also continue to forecast a relatively stable global pricing environment with expectations of price for Zimmer to be down between 2% and 3% as compared to the prior year. Turning back to guidance, as indicated in our release we now project full-year 2015 adjusted diluted earnings per share for Zimmer on a standalone basis to be in the range of $6.30 to $^.40. We expect foreign currency translation will decrease our reported revenues for the full-year year by 6.5% to 7%, because our hedging program only offsets the impact of currency used on earnings, our updated guidance reflects further strengthening of the U.S. dollar against other currencies since our last earnings call. Lower anticipated earnings and profits from our international units has to further effect of changing the anticipated mix of those earnings and profits in favor of higher tax domestic operating unit, we therefore now anticipate the adjusted effective tax rate for Zimmer on a standalone basis to be approximately 27% for the full-year. A similar rate is expected for the combined enterprise post closing this compares with previous guidance of 26% to 26.5%. Turning to synergies and accretion associated with a pending Biomet merger as indicated in our release, we now expect accretion of $0.95 to $1.05 and adjusted diluted earnings per share in the first 12 months following the close of the transaction. This change is related to increased foreign exchange headwind associated with the acquired revenue of Biomet. Additionally, assuming the transaction close in May, we would anticipate approximately one-third of the accretion to be realized in calendar year 2015. After extensive integration planning which has been ongoing since the announcement of the pending merger with Biomet, we now expect net annual operating synergies to reach $350 million by year three post close. This compares with prior guidance of $270 million, with this in mind and assuming the pending merger transaction is closed no later than the end of May, we would expect revenues to grow organically between 1.5% and 2.5% over pro forma 2014 revenues or between $6.17 billion and $6.2 billion. This revenue number includes our expectations for divestiture remedy; we anticipate the diluted weighted average shares outstanding for 2015 to be between 193.5 million and 194 million shares including the shares issued to consummate the Biomet transaction. Together with the anticipated synergies, we would expect calendar year 2015 adjusted diluted earnings per share to be in a range of $6.60 to $6.80. For 2016 modeling purposes there are certain timing issues to consider. Only a modest amount of the $135 million in year one post, post synergies are reflected in the calendar year 2015 earnings guidance. That is due to the lag in capturing projected cost synergies in contrast to the immediate negative effect to the anticipated remedies. Those remedies generally take the form of product line divestitures which will result in an immediate loss of revenue and associated operating earnings. As we indicated in our last call synergies realization will be more heavily weighted to the back half of first 12 months post closing and accelerate into subsequent operating periods. As a result this anticipated phasing as well as the announced increase of projected synergies we expect the growth rate and adjusted diluted earnings per share beyond calendar year 2015 to also accelerate. As an example, 2016 adjusted diluted earnings per share should grow at mid teens or higher rate compared to 2015 guidance of 650 to 680. Lastly for 2016, you should be using a fully diluted weighted average share count of approximately $209 million. Finally, please not that other than Biomet our guidance does not include any impact from potential business developmental activities or other unforeseen events. David, I'll now turn the call over to your.
David C. Dvorak:
Thanks Jim. Zimmer made good progress in the first quarter of 2015 which would not have been possible without the dedication of our team members around the globe. In addition to achieving steady global revenues and driving ongoing commercial releases, we've been fully committed to integration anticipation of our pending combination with Biomet. Our new company will be forged in the principles and best practices that have made both Zimmer and Biomet leaders in the musculoskeletal healthcare. On that basis we look forward to continuing to serve the global healthcare community with innovative solutions and compelling value. And now I would like to ask Julie to begin the Q&A portion of our call.
Operator:
[Operator Instructions] if you can please limit yourself to one question and one follow-up question. The first question comes from Bob Hopkins from Bank of America, please go ahead.
Robert A. Hopkins:
Great, thank you. Can you hear me okay?
David C. Dvorak:
We can Bob. Good morning.
Robert A. Hopkins:
Great. Good morning. So, the first question I want was is just on the actual Biomet deal. It seems like the FTC is taking longer than you initially thought. I was wondering if you could give a sense as to why and is the reason that they want to wait until their remedies are actually executed?
David C. Dvorak:
Well, there are differing requirements in different jurisdictions. It is the case that for instance, in Japan you can come to an agreement as to what the divestiture needs to look like and then subsequent to the closing of the primary transaction execute on that, whereas it’s a more concurrent requirement with the closing in jurisdictions like Europe and the United States. But to back up a little bit on the status, Bob, in general, we’re very pleased to have received the clearances from both the European Commission and Japan FTC. As you know that we’re focused on the US FTC, but I would add that we’re encouraged by the substantial progress we’re making to complete the final steps there as well and it is our expectation that we’re going to get the transaction closed in May. And maybe just add a little bit more color to that. In the scheme of the overall transaction, this category is coming up very consistent with what we anticipated in our diligence work pre-execution of the deal and I think we’re going to land in a very good place and it just took a little bit longer than we thought.
Robert A. Hopkins:
But the main reason, just to be clear, for it taking a little bit longer than you thought is the process around remedies, is that a fair statement?
David C. Dvorak:
That’s correct.
Robert A. Hopkins:
And then as a follow-up, on the guidance, two quick things. One, just doing some quick math here. It looks like what you’re comfortable with for calendar 2016 is something below $8 a share. So, one, is that correct? And also Jim, could you just highlight the different buckets of what’s changed in the guidance since you last communicated to us at the end of the Q4 call in terms of either specifics on FX or synergy or financing costs, you talked about tax rate. Just wondering what changed and if my math is right that you’re kind of comfortable for now a little bit below $8 for 2016?
David C. Dvorak:
So, I guess, first of all, yes, we’re comfortable with something below $8, but 2016 obviously based on the mid-teens or higher, sort of, growth rate expectation. Understanding, Bob, that there is a lot of work to do between now and 2016 in developing operating plans which is what we would typically be doing before providing a more detailed guidance, which will come, eventually. And then with respect to what has changed is really two things, I guess, well, maybe three, the timing. So, the realization of the synergy is, obviously, the basing of the actions that have to occur to capture those synergies doesn’t happen until obviously we close the transaction. To the extent that there’s been a slight delay in our expectations with respect to when the transaction would close, the opportunity we have to capture those synergies just gets deferred. Secondly, the headwind associated with foreign currency translation is the other most - really the most significant change and that’s reflected both in the update that we’ve provided on the standalone guidance as well as the $0.10 take-down and the accretion expectations for the first 12 months post closing. The one other change you I think mentioned as well is the fact that we are anticipating relative to our original modeling a somewhat higher effective tax rate and that really is a result of both the effect of foreign currency translation is having on the foreign earning, post Zimmer and Biomet as well as on the fact that the interest cost associated with the deal financing significantly below what we had originally anticipated. So if you go back to the original deal model we would have had a more significant tax shelter in the U.S. associated with the deal financing and those - that really covers the three things that I said that are impacting on the change in the outlook.
Robert A. Hopkins:
I just one more and I will let others jump in here, but could you give us - what was the FX hit on the combined company in Q4 versus the FX hit now because the guidance before was including some other things like you said for Biomet it was $0.30 offset by $0.20 of savings from interest and then Zimmer was $0.20 net of hedging. Can you just give us a sense as to how much currency is a headwind now versus the beginning of the year?
David C. Dvorak:
Sure, well on a standalone basis it is another $0.05 or so a quarter obviously with take down of $0.20 and that is a combination of the FX as well as the pressure we are seeing with respect to the effect of tax rate and on Biomet it is a little more than the $0.10 take down because there is an offset in the form of some interest savings relative to what our expectations were prior to launching the senior notes.
Robert A. Hopkins:
Very good. I will get back in queue. Thank you.
Operator:
Thank you. The next question comes from Matt Taylor from Barclays. Please go ahead.
Matthew C. Taylor:
Hi thanks for taking the question. I just wanted to ask you guys about the closing here, you are saying May now instead of April. Can you just talk about the last steps for closing in the U.S. and what is your guidance imply when you’re talking about the lower growth for the year in terms of U.S. divestiture? Can you talk about what it looks like versus Europe or Japan?
David C. Dvorak:
There really isn’t too much more to add Matt to the status of the clearances, it’s U.S. focused at this point in time and we do anticipate receiving FTC clearance in the United States and being able to bring the transaction to close in the month of May.
James T. Crines:
Yes, and with respect to the divestitures when we quote the 1.5% to 2% constant currency growth expectation for the top line that is over pro forma 2014 revenues so where that is really an apples and apples comparison we stripped out the anticipated divested revenues out of 2014, and then where the divestiture, the divested revenues hasn’t impacted obviously on the accretion expectations and nothing has changed with respect to the impact that those divested - product lines divestitures are going to have in relation to accretion. What has changed as I said is the foreign currency headwind that we’ve now factored into the updated guidance on accretion.
Matthew C. Taylor:
And maybe just taking a step back if you think about the guidance that you’ve provided along for the transaction conceptually I guess number one, are you seeing any disruption with the combination around the corner and do you still expect that you can grow in line with the market and faster than the market after the merger closes?
David C. Dvorak:
We absolutely do Matt being that we characterize the progression from the point of close integration beyond this guidance is consistent with that in line with market in the initial stages accelerating above market is we get deeper into executing these plans, so no changes whatsoever it come of our integration plan, I would tell you that the intermediate to longer term I think there would be opportunity is even greater to create value by virtue of this combination and that should be reflected in the intermediate to long term on the top line?
Matthew C. Taylor:
Great, thank you very much.
David C. Dvorak:
You are welcome. Operator Thank you the next question comes from Mike Weinstein from JP Morgan. Please go ahead.
Michael Weinstein:
Hi good morning guys, just want to start with the quarter Jim can you just outline for us the impact of difference in selling days outside the U.S. think you had couple more days this quarter than you had the year ago?
James T. Crines:
That is very Mike so that accounts for about 2.5 points of growth on the top line and that is why the all the growth rate that we quoted in our comments had been adjusted to strip out the effects of the extra billing days to help you have an opportunity to go back through the transcript will get the day rate growth both consolidated and by product category.
Michael Weinstein:
Okay. That’s very helpful thanks Jim. So, let me just circle back now on the 2015 implied guidance, you know, Bob asked the question. Are you basically endorsing something below $8, but maybe just to be a little bit clearer that because the mid teens are better growth could apply anything from $7.50 all the way up to $8? Do you want to be any tighter relative to that band just to street expectations or corporately release that?
James T. Crines:
Well, you know, at this stage, again, to the extent that we haven’t done, you know, the bottom up operating plans for 2016, it’s right to think about a wider range perhaps then to put a finer point to it. You know, something in the order of 15% to 20%, but I think you’ll get beyond that. The range gets to be a bit too wide.
Michael Weinstein:
Yes, understood. Let me just ask the last question, maybe then just on the comment you made about pro forma revenue growth and I think what you said was 1.5%, 2% revenue growth, and correct me if I am wrong, pro forma once the deal is closed. That’s what included the impact to divestiture. So, are you saying that the divestiture is way down to 1.5% to 2% or that’s adjusted for the divestitures?
James T. Crines:
Adjusted. So, it’s1.5% to 2.0% and we’ve taken out…
Michael Weinstein:
Apart.
James T. Crines:
Yes, we’ve taken out what we anticipate will be the divestiture revenues out of the base.
Michael Weinstein:
So, you…
James T. Crines:
Yes.
Michael Weinstein:
So, that basically would imply pro forma growth pretty consistent with what the company is doing right now?
James T. Crines:
That’s correct and understand, you know, with the deal is now anticipated to close in May. I mentioned that there is a lag capturing cost synergies. There’s also a lag in capturing the cross selling opportunities. Those will wrap up over time and that’s reflected in that top line expectation for calendar year 2015.
Michael Weinstein:
Okay and one last question I’ll sneak in. So, are you at a point where you can give us a little bit more in terms of what you’re doing with the sales organization to maybe tie up some of the better reps and distributors post close?
James T. Crines:
We have very well-developed plans, but wouldn’t want to start articulating anything, you know, specific in advance of the closing and the execution of those plans, Mike. I think in that area though, it’s probably worth noting that our stability within the sales force is quite good on a global basis. We’re not seeing accelerated attrition rates and I think we are going to enter the period to execute this plan in a very good position.
Michael Weinstein:
Great. Thank you guys.
David C. Dvorak:
Appreciate it.
James T. Crines:
You’re welcome.
Operator:
Thank you. The next question comes from Glenn Novarro from RBC Capital Markets. Please go ahead.
Glenn J. Novarro:
Hi! Good morning guys. One of the things you did this morning is you raised your net annual sales synergy guidance from $270 million to $350 million and in the guidance there is an assumption for sales dis-synergies near-term plus costs savings. So, can you walk us through what’s changed, are the dis-synergies a little bit greater and the cost saving is a little bit greater, serving as an offset. Just a little bit more clarity there.
David C. Dvorak:
Yeah, Glenn I think that we haven’t provided a breakout. You’re right to reference that synergy number as a net number, but just to give you a directional response. It is more related to opportunity on the expense synergy side than any change in assumption on revenue dis-synergy.
Glenn J. Novarro:
Okay, and what are you saying from a cost savings point of view today that gives you more confidence that it would come in greater?
David C. Dvorak:
Well, we obviously had the ability over the last many months to get access to a lot more information and bring teams together and do a lot more detailed planning and it’s really with that information and the process that we’ve been executing to on the development of these plans that clarify the opportunity and we feel very, very confident in the opportunity, the plans that have been developed, and in our capability to execute and realize those savings.
Glenn J. Novarro:
Okay, and then just one quick on the end market. Your hip number relative to our expectations came in a little bit light, but so did some of the competition as well and I know from year-to-year, some years knees do better than hips and so forth. Do you have a feel for why maybe hips have come in a little bit lighter to start off the year and then as a follow up, do you have a view on robotics coming out of AAOS, you heard more than robotics, you heard Smith & Nephew and J&J doing some partnering. Just your view on robotics going forward as well?
James T. Crines:
I think that the worldwide hip market does look like it has stepped down a bit from what it came in at for the entire year 2014; I wouldn’t over read that one quarter data point. However, it felt to us though more of that was driven in the United States we had a little bit of a step down market growth rate wise as well noted in Asia Pacific but I don’t see any major trend that is driving that that would be indicative what one should anticipate for the balance of the year and would still try to take more towards an expectation of 2015 is going to look a lot like 2014 and 2013 overall with respect to robotics again we very much believe in innovating our way that improves the quality of care and outcomes and at the same time does so in economically responsible in responsive way to various stakeholders within the system for several years now. We have been developing technologies that we believe are smaller, cheaper, faster to bring about better clinical solutions and reproducible solutions in a cost efficient way and continue to believe that those platform technologies including our high assist and patient specific instruments in soft tissue balancing systems pre operative planning systems and then as I mentioned these inter-operative technologies are going to be able to serve customers and patients very well in that regard. So we think that the need is there, our solution and strategy within that space is a bit different approach and we are very confident that we are on a great track to deliver value to those stakeholders. We don’t think that going backwards in procedure time for example for changing the work flow in a fundamental way is going to lead to better patient outcomes and in fact those patients outcomes could be said in reverse relative to current capabilities and that is one area that one is going to have to be mindful of but it’s an exciting area for innovation in general and we like our platform technologies and the strategies that we have in place and we are executing to.
Glenn J. Novarro:
Okay, thank you.
David C. Dvorak:
You’re welcome.
Operator:
Thank you. The next question comes from Rich Newitter from Leerink Partners. Please go ahead.
Richard S. Newitter:
Hi thanks for taking the question. I just was wondering just going back to the timing of the deal, I know that you feel confident in the deal closing in the May but I’m just curious how should we or how can you help us get comfortable that the deal close in May is in fact the right time when previously it was April and then before that you were very confident that it was 1Q, 2015 just maybe help us get a better feeling that May is in fact probably the last potential push out or is that even a fair conclusion to draw?
David C. Dvorak:
We are confident in closing in the month of May and I guess that the fact these split would emphasize with you is that we have regulatory filings across the globe as it relates and you’re trying to estimate the specific timing for close with a lot of variables in that equation originally we are now down to the point where we have one jurisdiction and you should assume that we are pretty knowledgeable about what is outstanding within that jurisdiction and what our path forward the optionality to address any issues that are open within United States and so it’s a shorter list, we’re very knowledgeable and well positioned to address what needs to get addressed and on that basis are expressing a high degree of confidence that we’re going to get it done in May.
Richard S. Newitter:
Got it. And then just one follow-up, I was on another call earlier, so if someone asked this, I apologize but just we’ve also have heard from some competitors that are attempting to move down a more value implant route there has been talk of value implants. can you provide your thoughts on how the market may or may not accept this type of offering and what is Zimmer and Biomet’s competitive response should it actually begin to take off? Thanks.
James T. Crines:
Well I think that the positioning of technologies and the solutions, one needs to make sure that we are innovating in a way and delivering value to a system that is going to increasingly become cost conscious and has for the last many years. The data points that I think are worth emphasizing is the stability of the pricing environment, it’s a pretty narrow bandwidth in our experience over the last not just quarter or two but couple of years, by way of price experience, we’re continuing to maintain price and retrieve mix opportunities for our premium technologies and all those price points. And the last point that I think is worth emphasizing is that competition is healthy if we can prove out value for the premium technologies then those prices won’t be held but that’s a fair challenge that should be placed on anyone that’s operating within these marketplaces. It’s going to be the case, however, that if one of these so called value implant providers cause harmful effects to patient outcomes that with the movement away from fee for service in jurisdictions like the United States and the cost of re-admissions or complications in those cases being internalized relative to the provider they are going to care deeply about making sure that they get a right for the patient as they should. So if someone is out to save a little bit of money in exchange for not delivering the right kind of patient outcome, the economic system is going to penalize that provider in a material way in a much more significant manner than it has historically. So we like the clinical results, the quality systems, the attention to detail in the design, manufacture, and commercialization of these solutions living this world and are highly confident that we understand what the stakeholders and customers expectations are and how to partner even more deeply with those providers to bring about a great patient outcome in a cost effective way in the future. And if anything are even more excited about our opportunity and confident in our capability to contribute to that to that equation by virtue of the Biomet combination.
Richard S. Newitter:
Thank you.
David C. Dvorak:
You’re welcome.
Operator:
Thank you. The next question comes is from David Roman from Goldman Sachs. Please, go ahead.
David H. Roman:
Thank you. Good morning, everybody. I want to switch back to the business a little bit and ask a couple of product line questions. And specifically, I was hoping you could just give us a little bit of an update on the trauma business given what has been some fluctuation in the growth rate in the past couple of quarters that looked to have stabilized, but maybe help us understand the opportunities there going forward. And then secondly, spine, I think you are now going on three pretty solid quarters particularly in the United State. Could you may be just help us understand what are the drivers underpinning that turnaround and can we see that growth continues as the comparisons get harder in the back half of this year?
James T. Crines:
Sure. With respect to trauma we stepped backwards a little bit initially over the last few quarters and our U.S. performance maintained pretty solid performance in the OUS markets and there sort of a simple answer to the progress that we’ve made, we’ve invested in our product portfolio an innovation the Zimmer Natural Nail line is an example of that, the NCB periprosthetic plating system is another good example of that. Our XtraFix system showing up that capability on the external fixation has lead us to a much more competitive portfolio more recently just a radius platting system getting launched and we’ve really rounded out our portfolio and put our commercial teams in a better position to compete. And the other half of that is sales force specialization and focus and I think that we’ve advanced more rapidly in the OUS markets, in the U.S. markets. But I think we’re beginning to catch up in the U.S. markets. When you look at the platform that we’ve created on the Zimmer side and add to that which is a substantial ad what Biomet possesses by way of product portfolio, all the does is enhance our capability to win and take share within the trauma space post closing the deal. It also enhances our capability to build out sales forces that are specialized within the trauma marketplace wherever that makes sense to do so geographically across the globe. So, it’s one of the areas among several sports, medicine, extremities, trauma, surgical, where this combination and the scale are going to greatly enhance our growth opportunities and I’m very confident that were you going to see is those businesses collectively picking up our overall top line performance as we get deeper into the integration and executing the cross-sell opportunities and the build out of the commercial team. Spine is a similar story. You know, it was all about investing and innovation. We had about 12 launches in 2014. There is a lot of a runway with those launches in the pipeline and the Zimmer side is rich. The person were picking up through the Biomet combination are very, very complimentary to the Zimmer portfolio. So, day one, we’re going to end up with a very competitive offering on the core fusion side and some really terrific innovations within the pipeline, and again, a stronger than ever sales Force team on a global basis. So, I would expect us to continue to perform very well. You know, obviously, have more visibility to the Zimmer spine business at this point in time, but I’m highly confident in our ability to sustain those attractive growth rates or if anything accelerate on the Zimmer side going forward for our spine business.
David H. Roman:
Okay, that’s helpful and maybe just as a follow-up on the P&L, Jim. I know in your prepared remarks you talked about some of the drivers of gross margin. Can you maybe just go into a little bit more detail just on how much of that is hedging, where it’s hedging gains versus performance in the underlying business and then presumably foreign currency rates hold where they are, that has benefit becomes a headwind as you analyze that. So, the underlying gross margin of the business probably being a little bit lower, than that [7.5%, 8%] [ph] the year quoting for this quarter?
James T. Crines:
Okay, well so let me start with the foreign currency hedge gains that were recognized in the quarter. We recognized, David, $28 million in cash flow hedge gains in the quarter compared to approximately $5 million in the prior year quarter. You know that’s a detail that we provide in our periodic disclosures. You’ll be able to track, you know, what’s getting recognized and what we expect to recognize over the next 12 months. That difference year-over-year, by itself about two points of improvement in the ratio, but that is offset by approximately 130 basis points related to higher access and obsolescence charges in the quarter compared to the prior year quarter. The higher charges you know, charges were driven by ongoing commercialization in new products as well as the effect of placing more inventories into distributor and hospital consignments and a product recall as well in the quarter that higher-level of charges in the quarter is expected to moderate going forward.
David H. Roman:
Got it. Okay. Thank you very much.
James T. Crines:
You’re welcome.
Operator:
Thank you. The next question comes from Bill Plovanic from Canaccord. Please go ahead.
William J. Plovanic:
Great. Thanks. Good morning. Can you hear me okay?
James T. Crines:
We can Bill, good morning.
William J. Plovanic:
Good morning. So, actually just a point of clarification if I could. As you discuss divestitures, you’ve already divested the European assets and then as you look at what you know what you have two divest in Japan and then, you know, there’s a range for which you were you looking at in the US. I was just wondering if you could provide nominally the combined Biomet/Zimmer, you know, what was that on a nominal basis whether an exact or a range, it’s just to help us for modeling. Then, secondly, when you talked about closure in many you know, should we think late May or June 1 or May 1. How should we think about that in the model?
James T. Crines:
Sure. Well, first of all, I don’t want to at this stage because, you know, we haven’t closed the transaction or completed the divestitures even in Europe. Although, we have, obviously, signed definitive agreements, we have still yet to close. You know, that’s a detail, Bill, that were just going to hold off providing until the transaction closes but one we understand that will need to be provided once it does close and then your other…
William J. Plovanic:
Just for the closing day, should we - you’re talking about May. When in May should we…
James T. Crines:
Yeah. Well, I’ll just share with you the basis for some of the internal modeling that we’ve done and further guidance, you know, that we’ve provided, just a bit naked a little simpler for us; maybe for you as well the end of May.
William J. Plovanic:
Okay. Great. That’s all I had. Thank you.
Operator:
Thank you. The next question comes from David Lewis from Morgan Stanley.
David R. Lewis:
Good morning. I thought I’d come back to the 16 synergies for a second. So, you have a couple of dynamics. You’re obviously raising long-term synergy numbers around 20%, but the 16 number obviously is falling below a lot of the consensus expectations and you talked about a few issues FX, tax, and timing, but tax and FX seem largely accounted for. So, the biggest factor seems to be timing and I’m trying to figure out is this deal close timing or the realization of synergy timing because it feels like the latter, but could you give us a lot more detail on that second piece if it truly is the realization of synergy timing because it doesn’t seem like a four to six week delay in the deal would move the number in 2016 that dramatically. So it must be on the backend, but it’s hard to understand exactly what that is and if you could give us more detail that would be great, and a quick follow-up.
James T. Crines:
I should tell you, David, that it is deal close timing. You know, as you know, we’ve reiterated our expectations for synergies in the first 12 months following the closing of the transaction at $135 million. So, that’s not changed and then we’ve actually increased, as you said, the guidance for total synergies by years three to $350 million from $270 million. Now, it is the case that, that additional $80 million will come later, not in the first 12 months obviously, but it will come in years two and three following the closing of the transaction. In reference to an earlier question, I talked about the three things that have really changed relative to the earlier expectations. Europe, one is timing, one is the currency head win, the tax rate is the other thing that has changed. I will say and this is a reason we’ve provided detail in our scripted comments that when we look at some of the analyst models that are out there that it does seem as if in many cases the average share count is getting understated for 2016. I think that’s something to look at. Again, we’ve provided on this call very specific guidance on what we’re expecting to see in the average share account remembering that we’ve put the share repurchase program on hold. We’re going to be issuing another 32 million shares to consummate the transaction and then beyond that we’re going to continue to see an increase, you know, until such time that we put the share repurchase program back in place and in average shares associated with the employee equity incentive program.
David R. Lewis:
Okay and then maybe just - may be a quick question on ‘15 guidance for a second. I know there was currency tailwinds and some other obsolescence and the inventory headwinds, but it does seem like there was 70 bips of underlying margin improvement and that particular margin for me, Jim, in the first quarter; dinner, why would that not help to offset some of the incremental Fx and tax pressures in ‘15? It looks like that would have, you know, maybe offset at least half the $0.10 or $0.15 incremental ‘15 headwind.
James T. Crines:
Well, again, it’s the $80 million of currency headwind in the quarter and that’s high margin revenue. So, while the hedging program is effective and, at least, partially offsetting the effect of that, it just doesn’t fully offset it, and some of this, as well, has to do with where, you know, what’s happening. Where there is very significant currency headwinds, for example, is in some of the emerging markets and in those markets while we do hedge, we don’t hedge to the same level because the cost of hedging is so expensive with respect to those currencies.
David R. Lewis:
Okay but should the underlying margin performance, you know, if there was underlying improvement in the first quarter, should we expect that improvement to sustain itself throughout the remainder of the year or not?
James T. Crines:
Yes. Now, we’ll continue to see that through the remainder of that is reflected in the updated guidance that we provided.
David R. Lewis:
Okay. Thank you very much.
James T. Crines:
Sure.
David C. Dvorak:
Julie, we have time for one additional question.
Operator:
Okay. Thank you. The last question comes from Larry Biegelsen from Wells Fargo Securities. Please go ahead.
Craig W. Bijou:
Hi guys. It’s actually Craig on for Larry. Thanks for squeezing us in.
David C. Dvorak:
Sure.
Craig W. Bijou:
I just wanted to quickly ask about EPS growth beyond 2016, I know you provided guidance of mid-teens or higher in 2016 and then just wanted to know for the combined company what should we expect from EPS growth?
James T. Crines:
I'll just reference the longer term, what we have talked about in the past and continue to focus to put together our longer term strategic plans and that is to drive in the range of 8% to 10%growth in adjusted earnings per share over the long-term. Obviously with the combination and now the updated guidance that we provided on synergies in the near-term that growth rate is going to be higher but long-term as I said you know we've put together our five year plans, strategic plans, the management team is going t0o be focusing on what it need to do to drive that earnings growth in a range of 8% to 10%.
Craig W. Bijou:
Okay thanks and then just as a follow-up the tax rate, you mentioned the tax rate increasing in 2016 and just want to see where that goes in 2017 and beyond. Can you get back down to what your original thoughts were on the combined tax rate?
James T. Crines:
That’s a very good question, there are a couple of things that we - there is a lot of tax planning that is already underway with respect to the combined - the anticipated closing of the transaction. And I will tell you that that has been more focused on what the combined enterprise can do to get access to the cash that’s going to be accumulating offshore and there are some things that we will be able to do that will enable us to access quite a bit of cash that’s going to be accumulating offshore something in the range of $3 billion to $4 billion overtime. And that obviously is going to provide the management team with some opportunity to do some things that could potentially drive leverage on the bottom-line including getting ahead of share repurchase program back in play at some point accelerating the debt repayments during the leverage ratio inline with something that is more inline with what you would expect to see for an investment grade credit. And then we will be pivoting to once the deal is closed some tax planning initiative that will focus on what the enterprise can do to drive down the effective tax rate overtime. We know that that’s going to involve among other things moving manufacturing source in some cases sourcing more of the demand that’s offshore from our offshore manufacturing facilities and do believe that that’s going to provide opportunity to bring that effective tax rate down.
Craig W. Bijou:
Is that something that’s going to happen immediately after close? Can you start seeing the benefit?
James T. Crines:
Well the planning will certainly happen immediately, but the steps that it will take to actually realize the benefit will take more time, because particularly when you are talking about changing sourcing within our own network, we certainly have control of that but that takes time, those manufacturing transfers take time and then it take time to show up in the P&L to the extent that that inventory - the tax benefit will be recognized as inventory that’s getting sourced from new locations is getting so.
James T. Crines:
Okay. Thanks for taking the questions.
David C. Dvorak:
I would like to thank everyone for joining the call today and for your continued interest and support for Zimmer. We look forward to speaking to you on our second quarter conference call, which is scheduled for 8:00 AM on July 30, 2015. With that, I'll turn the call back to you, Julie.
Operator:
Thank you again for participating in today's conference call. You may now all disconnect.
Executives:
Bob Marshall - VP of IR David Dvorak - CEO Jim Crines - CFO
Analysts:
Mike Weinstein - JPMorgan Jon Demchick - Morgan Stanley Bob Hopkins - Bank of America Matt Taylor - Barclays Larry Biegelsen - Wells Fargo Securities Bill Plovanic - Canaccord Genuity Joanne Wuensch - BMO Capital Markets Mike Matson - Needham & Company Glenn Novarro - RBC Capital Markets
Operator:
Good morning. I would like to turn the call over to Bob Marshall, Vice President, Investor Relations and Treasurer. Mr. Marshall, you may begin your call.
Bob Marshall:
Thank you, Julie and good morning and welcome to Zimmer's Fourth Quarter 2014 Earnings Conference Call. I'm here with our CEO, David Dvorak and our CFO, Jim Crines. Before we start, I would like to remind you that our discussions during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties. Also, the discussions during this call will include certain non-GAAP financial measures. Reconciliations of these measures to the most directly comparable GAAP financial measures are included within the earnings release, which is available on our website at investor.zimmer.com. With that, I'll now turn the call over to David.
David Dvorak:
Thank you, Bob. Good morning, everyone, and welcome to our earnings call for the fourth quarter of 2014. This morning, I'll review our fourth quarter financial results, providing commentary on 2014 and highlights from our performance. Jim will then provide additional financial details. I'll state all sales in constant currency terms and all earnings results on an adjusted basis. In the fourth quarter and throughout 2014 Zimmer delivered solid sales growth across several key product categories as well as in the Europe, Middle East and Africa region and the Asia Pacific region. Consolidated net sales for the quarter were $1.22 billion, an increase of 2.4% and our earnings per share were $1.71, an increase of 3% over the prior year period. Full year sales for 2014 were $4.67 billion, an increase of 2.4% over 2013 and our earnings per share were $6.06, an increase of 5.4%. Turning to each of our geographic regions, in the fourth quarter our Europe, Middle East and Africa business increased sales by 6.9% over the prior year and our Asia Pacific business delivered impressive 8.4% growth. Our sales decreased by 1.6% in the Americas on challenging comparisons in the prior year period, both largely to the exceptional market growth rate experienced in U.S. procedural volumes in 2013 attributable to factors related to the implementation of the Affordable Care Act. Before reviewing the performances of each of our product categories, I’d like to first comment on market conditions. We saw global musculoskeletal markets demonstrates stability in the fourth quarter despite soft and macro economic conditions in certain geographies supporting our confidence for 2015 and beyond. While increased procedural demand in the fourth quarter of 2013 resulted in challenging sales comparisons in the Americas, we believe that the steady performance of this market over the last two years signals a stable demand for musculoskeletal solution including premium technologies. With respect to pricing, we experienced price pressure of negative 2.4% both in the quarter and for the full year consistent with our expectations. Against this backdrop, Zimmer’s market leading knee business increased sales by 2.5% in the fourth quarter, an overall steady performance reflecting positive volume and mix of 5.6% and negative price of 3.1%. The Europe, Middle East and Africa region delivered 6.1% growth, the Asia Pacific region increased sales by 6.2% and America sales were flat against prior year growth of 10.7%. Throughout the fourth quarter, focussed execution expanded the ongoing growth of our knee business in key overseas geographies while supporting the stable domestic performance. We continued to accelerate global sales for Persona, the personalized knee system, our flagship total knee which is build on the clinical legacy of our proven next gen knee replacement system with design innovations to offer enhanced fit, feel and function. Persona was also designated, or designed in concert with our next generation suite of intelligent surgical instrument systems, including patient-specific instruments, the iASSIST Personalized Guidance System and the eLIBRA Soft Tissue Balancing System. Our fourth quarter growth in knees was also supported by the ongoing commercial expansion of our early intervention and joint preservation solutions, including our Gel-One single injection Hyaluronate treatment and the Zimmer Knee Creations' Subchondroplasty joint preservation procedure. Turning to hips, in the fourth quarter we increased sales by 0.6% reflecting positive volume and mix of 3.2% and negative price of 2.6%. Sales increased by 3.7% and the Europe, Middle East and Africa region increased by 6.2% in the Asia Pacific region and decreased by 4% in the Americas. As in previous quarters our performance was led by growing sales for premiums solutions such as the Continuum Acetabular System, BIOLOX delta heads and product offerings leveraging Vivacit-E, our advanced Vitamin E infused bearing material. In 2014, our hip business also made important progress with respect to innovations that we believe offer compelling value to the evolving healthcare market. By way of example, in 2014 Vivacit-E hip liners completed more than 90 million cycles of laboratory ware testing without oxidation or strength reduction making Vivacit-E the only hip replacement technology laboratory tested to mimic the number of walking steps and long term in Vivo environment a patient will typically experience during their life time following hip replacement. Results such as these have supported Vivacit-E commercial growth as well as its acceptance in the clinical and payer communities reinforcing our confidence in this platform technology. And in November our innovative Synovasure molecular diagnostic test became eligible for sale in several European countries. Synovasure is the first test of its kind specifically designed for the diagnosis of periprosthetic joint infection and offers clinician’s rapid and accurate results. Looking forward, we’ll focus on continuing to strength our global position in hips by leveraging innovative technologies such as these which further enhance the value of our personalized solutions. Our Extremities business delivered 6.2% growth in the fourth quarter, highlighted by impressive double digit performances overseas. Our Europe, Middle East and Africa business reported 19.4% growth over the prior year period, the Asia Pacific region delivered a 20.5% sales increase and our Americas business grew by 1.4%. Our outstanding results overseas were again driven by our highly successful shorter replacement portfolio led by the Trabecular Metal Reverse Shoulder. The Nexel Total Elbow and Trabecular Metal Total Ankle also delivered promising growth in 2014 and we plan to continue building on those performances. Turning to our trauma business, sales increased by 3.7% in the fourth quarter with our Europe, Middle East and Africa sales increasing by an impressive 11.7%, the Asia Pacific region delivering 5.7% of revenue growth and our Americas segment reporting the sales decrease of 1.7%. We continue to position our comprehensive range of trauma solutions which were led in the fourth quarter by strong sales for the Zimmer Natural Nail family and NCB Periprosthetic Plating System. The recently released Distal Radius Plating System also delivered promising early results. In 2015 and beyond, we plan to focus our U.S. execution for improved growth in trauma, while continuing to expand our footholds in key global markets. Zimmer spine business delivered impressive 9.1% growth in the fourth quarter, a performance which was accelerated by a cadence of innovative new product launches throughout 2014. In the fourth quarter, the Virage OCT spinal fixation system and the Optio-C interior cervical system continued to expand our customer base in the global spine market while driving volume and mix growth. We also achieved strong sales with our expanded biologics portfolio including new additions to our line of Puros Demineralized Bone Matrix Grafting products as well as implant systems leveraging Trabecular Metal technology. Looking forward, we plan to continue launching innovative portfolio additions to further enhance the value we offer to spine surgeons and their patients. Dental sales grew by 9.3% over the fourth quarter of last year. Our legacy portfolio led steady in the Americas while European sales were aided by our value based offerings designed in the P-I Branemark philosophy. Zimmer dental also continued to benefit from the stable performance of our market leading regenerative portfolio premium Trabecular Metal Dental Implants and custom milled Zfx CAD/CAM digital dentistry solutions. Sales for Zimmer Surgical and other category decreased by 1.9% in the quarter. We continued to face challenging domestic sales comparisons for this business stemming from the outstanding capital sales growth of our Transposal fluid waste management system in 2013. Nevertheless, we achieved steady revenue growth across several categories of our differentiated surgical portfolio in the quarter. There were strong sales of our surgical blade and power tools including standout performances in several key European markets. The A.T.S. Family of Automated Tourniquet Systems also continued to deliver promising growth. As the impact of prior year sales comparisons taper in early 2015, our global sales force will focus on driving its steadily improving topline in the year ahead. Looking forward, we intend to sustain Zimmer’s focus on growth in 2015 as we embark upon a new chapter of our company’s history by combining with Biomet. This landmark transaction which we continued to expect to close later this quarter marks an unprecedented expansion of our global organisation. Our combined company to be named Zimmer Biomet will possess a more comprehensive and diversified musculoskeletal portfolio for our customers, including attractive cross selling opportunities. Moreover, this merger will significantly enhance our innovation pipeline allowing us to more rapidly and costs effectively bring innovative new clinical solutions and integrated services to market. There are also a number of compelling operational synergies that will support our ability to execute effectively on a combined basis. Our joint planning teams have collaborated diligently over the last nine months to map out the seamless integration of our two organisations. We look forward to closing this transaction so that we may begin to realize the significant promise of this historic merger. With that, I’ll now ask Jim to provide further details on the fourth quarter and our guidance. Jim?
Jim Crines:
Thank you, David. I will review our fourth quarter performance in more detail and then provide additional information related to our first quarter 2015 sales and earnings guidance for Zimmer on a standalone basis. Our total revenues for the fourth quarter were $1,223 million [ph], a 2.4% constant currency increase compared to the fourth quarter of 2013. Net currency impact for the quarter decreased revenues by 3.8% or $47.5 million. The negative currency impact for the quarter related to the recent strengthening of the U.S. dollar against many international currencies which I will address in more detail in my guidance comments. Our adjusted gross profit margin was 74.4% for the quarter, an 80 basis point improvement over the fourth quarter of 2013. During the fourth quarter, we anniversary through charges related to the medical device excise tax. Together with lower inventory obsolescence and gains from our currency hedges, these improvements were modestly offset by manufacturing variances and negative price The company's R&D expense was flat when compared to the prior year. Zimmer remains committed to producing a pipeline of new and innovative products that will meet the needs of stakeholders and the evolving healthcare environment and help drive growth in future operating periods. Selling, general and administrative expenses were $459 million in the fourth quarter and at 37.5% of sales, were 90 basis points below the prior year. SG&A as a percentage of sales was 39% for the full year an improvement of 70 basis points. In the quarter and for the full year Zimmer continued to achieve process and operational efficiencies which have created opportunities to both invest in future growth as well as expand margins for the benefit of stockholders. In the quarter, the company reported pre-tax charges of $197.9 million in special items pertaining to global restructuring, quality and operational excellence initiatives, certain litigation and recent acquisitions. Adjusted fourth quarter 2014 figures in the earnings release exclude the impact of these charges which include $59.5 million related to quality and operation excellence initiatives in manufacturing logistics of sales, a $70 million provision pertaining to a patent infringement suit, $12 million connected with certain other litigation matters and $56.4 million in integration and other cost. Adjusted operating profit in the quarter amounted to $404.6 million, 33.1% or adjusted operating profit ration was 170 basis points higher than the prior year fourth quarter. Net interest expense for the quarter amounted to $12.5 million, which was flat when compared to the prior year quarter. Adjusted net earnings were $295.6 million for the fourth quarter, an increase of 2.4% compared to the prior year. Adjusted diluted earnings per share increased 3% to $1.71 on a 172.4 million average outstanding diluted shares. These adjusted earnings per share are inclusive of approximately $0.05 of share-based compensation. At $0.91, reported diluted earnings per share decreased 33% from the prior year fourth quarter reported EPS of $1.36. Our adjusted effective tax rate for the quarter was 24.6%, lower than prior year but in line with the expectation when we consider the global mix of our earnings and profits. Our reported effective tax rate for the quarter was 19.4%, as the majority of restricting and other special items charges are incurred in high tax jurisdictions. The company had approximately 169.7 million shares of common stock outstanding as of December 31, 2014, flat from 169.8 million as of December 31, 2013. Operating cash flow for the quarter amounted to $354.2 million, an increase of 18% over $300.2 million in the fourth quarter of 2013. The increase is driven primarily by improved collections of accounts receivable in certain European countries and the collection of an insurance recovery pertaining to prior period product liability claims. Net inventories were $1.169 million at the end of the fourth quarter, a decrease of $8.5 million from September 30, 2014. Adjusted inventory days on hand finished the quarter at 337 days an increase of 52 days as compared to the prior year quarter. As of the end of the fourth quarter, net receivables decreased to $912 million from $937 million in the fourth quarter of 2013 or 2.6% from the prior year. Our adjusted traded accounts receivable days sales outstanding finished the quarter at 64 days, a decrease of one day when compared with the prior year. Depreciation and amortization expense for the fourth quarter amounted to $92.6 million. Free cash flow in the fourth quarter was $270.5 million; $20 million higher than the fourth quarter of 2013. We define free cash flow as operating cash flow less cash outlays invest for instruments and property, plant and equipment. During the full year, the primary drivers for the increase in free cash flow include the insurance recovery reference to my earlier comments. Strong cash collections in our Europe, Middle East and Africa operating segment, and lower litigation related payments offset impart by ongoing investment in capacity-related projects as well as payments relating to certain tax position. Capital expenditures for the quarter totalled $83.7 million, including $34.5 million for instruments and $49.2 million for property, plant and equipment. I'd like to turn now to our guidance. I will provide first quarter guidance for Zimmer on a standalone basis. Additionally I will provide an updated on our expectations for accretion in adjusted cash earnings per share for the first full year following the expected closing of the Biomet transaction. We will provide full year 2015 guidance for the combined company after that transaction has been concluded. Moving on to our market assumptions for 2015, we believe that full year knee procedures will grow in the low to mid single-digits. We expect global market conditions will remain relatively stable in 2015 when compared to the full year 2014. In our earnings release this morning, we announce that the Company expect first quarter 2015 revenues to increase between 1.5% and 2.5% on a constant currency and building their bases when compared to the first quarter of 2014. At this time, assuming currency rates remain where they had been during the first month of this quarter, we anticipate foreign currency translation will decrease our reported first quarter revenues by an estimated 6%. Additionally, due to a change in our interim quarter end closing convention for certain international reporting units which is described in a periodic filing. The first quarter will reflect up to five additional billing days for those units which has the effect of adding an estimated 3% to our consolidated revenues for the quarter. Therefore on a constant currency basis with the additional billing days, we expect first quarter revenues to grow between 4.5% and 5.5%. On a reported basis taking into account the effective foreign currency translation, our revenues are projected to be between 1.5% and 0.5% below the prior year. I’d like to make the few additional remarks regarding the significant currency headwind we are facing as a result of recent move in currency rate in relation to the U.S. dollar. As we described in detail in our periodic filings we managed currency risk with derivative financial instruments, which has the effect of reducing potential volatility and the dollar value of cash flows. Over time our hedging program which has been in place and just spin off in 2001 has been refined and enhanced to include cost averaging, extended durations and emerging market currencies. And from a management perspective has been effective in reducing short term volatility and cash flows. While our program is effective in reducing volatility and cash flow, anticipated teams on hedge contract will release the earnings over the course of 2015 will also offset in part the impact of recent currency moves on earnings. As a consequence management expect to maintain necessary ongoing strategic investments of product development in sales and marketing. The anticipated reduction of volatility in the short term that would otherwise has impacted our expectations for 2015 will give us time to folks in other operating leverage that will drive sustained, long term growth in top and bottom line. Returning to guidance specific to the first quarter, we expect pricing to be minus 2% and minus 3% when compared with the first quarter of 2014. As you move down the income statement assuming currency remain at recent levels, we expect our gross margin ratio to be between 73.5% and 74%. This takes into account anticipated gains on foreign currency hedges principally from the Euro and Japanese Yen. We expect R&D expense for the quarter to be approximately 4% to 4.5% of sales, SG&A is expected to between 38.5% and 39% of sales for the quarter as we continue realize efficiencies from our global operational excellence initiatives to further level revenue growth assuming variable rates remained at recent level. We expect interest and other expense of around $14 million, similar to the net expense realized to our each quarter of 2014. We anticipated an adjusted effective tax rate to be between 26% and 26.5%, which is above our final full year rate for 2014. The increase is mainly attributable to the anticipated change in the mix of our global earnings and profit. We would anticipate that diluted weighted average share outstanding for the first quarter to be between 173 million and 173.5 million shares. You will note that our share repurchase program remains on hold pending the Biomet merger. In preparation for our pending merger with Biomet we are moving to an adjusted cash earnings per metric. We will add back amortization to our existing adjusted EPS in the first quarter of 2015. We expect amortization during this first quarter to be $24 million or approximately $0.10 per share after tax. Therefore 2015 first quarter adjusted diluted earnings share are projected to be in the range of $1.58 to $1.60. As indicated in our release we expected to report pre-tax charges of approximately $107 million within the first quarter of 2015 operating period pertaining to amortization, global restructuring, quality and operational excellence initiatives, interest and other expenses related to the Biomet transaction and other recent acquisitions. Therefore to arrive at our anticipated reported GAAP earnings per share you should subtract these charges of approximately $0.46 per share on an after tax basis. I would now like to provide an updated accretion and adjusted cash earnings per share in the first 12 months following the close of the Biomet merger. First of all, we remained confident in our previously disclosed net operating earnings synergy target of $270 million by year three. With the $135 million achieved within the first 12 months, we would expect that the chasing of these targeted net synergies to favor the back half of the first 12 months due to a structured transition planning that avoiding our necessary disruption. In addition after taking into account the effect of recent currency rate movements on the anticipated acquired earnings of Biomet as well as the favorable impact of now lower expected interest rates and acquisition related debt, we expect the accretion from the Biomet pending merger transactions have contribute $1.05 to $1.15 in the first full year following the close of the transaction. The previous range was from $1.15 to $1.25. We will provide more detailed guidance for the combined company after the closing of the merger with Biomet. Finally please note that our guidance does not include any impact from other potential business development transactions from unforeseen. David, I'll turn the call back over to you.
David Dvorak:
Thanks, Jim. Throughout 2014 Zimmer delivered on our commitment to drive growth through the focused commercial execution of a comprehensive and innovative portfolio of solutions for the evolving healthcare market. Our broad-based approach to product design and business innovation has positioned Zimmer to act on a transformational opportunity to enhanced our global scale by combining with Biomet. By bringing together two highly complementary companies in the muscular scale of space we’ll accelerate our shared vision of leading the industry by delivering exceptional value to healthcare providers, their patients and to our stockholders. And now, I’d like Julie to begin the Q&A portion of our call.
Operator:
Thank you, sir. [Operator Instructions] The first question comes from Mike Weinstein. Please go ahead.
Mike Weinstein:
Good morning, gentlemen. Thank you for taking the questions. I want to just try and dig into the FX commentary Jim just a little bit, the part where you talked about the net impact of FX were Biomet not hedged versus the reduced borrowing cost is very clear, I understand the $0.10 swing there but the commentary on Zimmer pre-Biomet was a bit confusing. So can you maybe just talk a bit about the impact of FX on Zimmer pre-Biomet in 2015 as we think about our models? And then in the context of that answer, can you talk a little about the FX hedging program because I'm aware that you had these long dated hedges. I just want to get a better sense of when they roll off and what impact that has not only on 2015 but on 2016? Thanks.
David Dvorak:
Sure. Maybe to frame it out a little more clearly, Mike. On a standalone basis for the full year, we’ll be expecting for Zimmer to somewhere in the range say $6.20 to $6.30 and adjusted earnings per share, that’s using our prior metric; you would add another $0.40 to that for the adjustments to get to the cash earnings major. And then if you add the $1.05 to $1.15 of accretion that we’ve provided yet assuming the transaction that close at beginning of the year, we’d be looking at for the combined enterprise at a range of 755 to 775, and as indicated that takes into account the headwind associated with currency not only on the acquired earnings of Biomet but also on Zimmer standalone earnings. And just to be specific about that headwind. With respect to the acquired earnings of Biomet its about $0.30 of headwind, but that’s going to be offset by about $0.20 of savings in interest on the acquisition related debt. With respect to Zimmer standalone earnings, yes, may there’s about $0.20 of headwind and that’s net of hedge gains that will be release earnings in 2015. And then as far as the hedging programs goes, as I indicated in my comment we with the refinements we made in that program over time, those hedges extend that as far as 24 months or more. As we described in the past the focus of that program is to hedge cash flows associated with intercompany transaction which turns as proxy but not necessarily a perfect proxy for the operating earnings connected with international operating unit. And the other thing to understand is we never fully hedge so the $0.20 that I reference with respect to the Zimmer standalone earnings as I said is net of hedge gains and if not for the hedging program would be frankly a multiple of that number.
Mike Weinstein:
Jim that’s incredibly helpful. I really appreciated. So only just follow-up there, so the Zimmer standalone you said 6.20 to 6.30 and that’s before-- that’s on GAAP basis the cash would be 6.60 to 6.70 on a standalone and then the $1.05 to $1.15 that’s first 12 months and obviously did you like some close yet. Do you want the street to have that full $1.05 to $1.15 that’s got to the $7.55 to $7.75 in the 2015 modelling assuming the closing ledger this quarter right on January 1?
Jim Crines:
That’s an excellent point Mike. As I said, you know, providing this – the guidance that I provided assumes that closing at the first of the year and that’s obviously not the case and for modelling purpose people need to be careful about what they including calendar 2015, because just as you pointed out, the accretion guidance is for the first 12 months following the closing of the transaction and again as I indicated in my remarks the other thing have to be thoughtful of it the fact that that accretion is going to favor the back half of the first 12 months following the close of the transaction just given the time that it takes to take the actions that are necessary to drive those synergies.
Mike Weinstein:
Okay. So just to make sure the contacts – the way to look at it is more prorated and obviously back half loaded for the $1.15 to $1.25 still unacceptable that $1.05 to $1.15 – don’t expect the full $1.05 to $1.15 obviously to flow through in 2015 that maybe the last three quarters of 2015 and the first quarter 2016 lane?
Jim Crines:
That’s right.
Mike Weinstein:
Okay. Perfect. Thanks. I'll drop and let others jump in.
Operator:
Thank you the next question comes from [Indiscernible] from Morgan Stanley. Please go ahead.
Jon Demchick:
Good morning. This is actually John – for David.
David Dvorak:
Hi, John.
Jon Demchick:
I had a quick follow-up on some of the information that you gave, Mike’s question. The main thing was really just trying to figure out what interest rate you guys are assuming that the new Biomet debt will be able re-finance that?
Jim Crines:
Yes. You could assume at this point and obviously we haven’t gone to market yet but we will certainly before the closing of the transaction, somewhere in the range of 3.5 of 3.75 on the acquisition debt.
Jon Demchick:
Okay, very helpful. And further I guess the real question. In December there is some news about the European Commission and needing to divest you know one Knee, one Elbow brand in Europe and then one total knee brand across two specific European countries. I was wondering if you could provide any additional detail to the size and allocation of these products and if not if you can discuss how these divestitures related to your expectations and what you think that means to you heading into FTC approvals in the U.S.?
David Dvorak:
Sure John as we stated previously the discussions with the regulators are tracking quite consistently with the anti-trust analysis that we performed prior to entering into the merger agreement. As you point out, last month relative to the European Commission we disclosed the proposed remedy package that includes the three pieces that you just referenced and we continue to work with the European Commission to finalize the remaining details for remedy package. We also continue to make progress as it relates to the U.S. and Japan although we are not in a position to provide any specifics on that we would do so as appropriate moving forward and all of this work leads us to reiterating what we said upfront that we still continue to expect to be in a position to close the merger before the end of the first quarter here.
Jon Demchick:
Thank you very much.
David Dvorak:
You’re welcome.
Operator:
Thank you. The next question comes from Bob Hopkins from Bank of America. Please go ahead.
Bob Hopkins:
Well thanks can you hear me, okay.
David Dvorak:
We can, Bob, good morning.
Bob Hopkins:
Great, good morning. So just a follow up on Mike’s question and your very helpful commentary about the $7.55 to $7.75 and as you just discussed there is a difference between closing and the beginning at the end of the quarter, you know we calculate that the difference is roughly $0.25 to $0.30 so you would subtract about $0.30 from that $7.55 to $7.75 range. I just want to check with you if that is math that you agree with?
Jim Crines:
Yes you know Bob they are colors that added color we’ll obviously be able to provide after the transaction closes in terms of what the expectations are so. Particularly with respect to the synergies which you know as we point out you know but still as we indicated back in April we are expecting $135 million in EBIT synergies in the first 12 months following the close, but again, you know those are going to be somewhat back-end loaded in those first 12 months, which you are doing is not unreasonable but again, just be mindful of the fact that as I said that synergies are going to be back-end loaded.
Bob Hopkins:
Right. So we missed one, you know one quarter of the synergy level or perhaps it’s a little bit more than the $0.30. Okay just trying to try – to a good number for the combined entity for 2015 relative to the information that you are providing. So two of the really quick things, one, Jim can you just give as far as theQ1 guidance is concerned that $1.58 to $1.60 what is the like-for-like number in the year ago period and then I also wanted to get your views on the U.S. hip number of minus 4% in the quarter that was sort of the one particular weak spot and just wanted to see if you could highlight what you think went on there in a little more detail?
Jim Crines:
So I said I think first quarter adjusted EPS you know in the prior year was $1.50 and you would add that roughly that had $0.10 to that you can say that the cash you know earnings measure so that the year-to-year comparison you are looking at to hit the similar sort of expectations for bottom line adjusted cash EPS and keep in mind that you know that includes about $0.05 of headwind related to currency ,there is another say couple of pennies of headwind related to the tax rate which will be higher in 2015 relative to2014. I will say with respect to the tax rate that there will be opportunities to reduce that overtime, but it requires changes in sourcing that to take time and then finally – given the fact that we put our share repurchase program on hold there is obviously no leverage you know on those bottom line expectations associated with any share ahead [ph] very little or no leverage associated with share repurchases.
David Dvorak:
Bob as it relates to the U.S. performance in the hip category that is an area that we look to improve upon moving forward obviously remember that that’s of of a difficult comparison we were in mid single digit growth in the U.S. or there are about in 2013 fourth quarter, so a lot of that sluggishness is driven by the math of the prior year terms. That said, you know we are obviously pushing more focus naturally with the Persona launch on the knee side and we need to energize the sales force and create more focus on the hip side, the product portfolio is very competitive as evidenced by the stronger performance of U.S. within that category. So the opportunity is clearly there.
Bob Hopkins:
Great. Thanks for the help
David Dvorak:
You’re welcome.
Operator:
[Operator Instructions] the next question comes from Matt Taylor from Barclays. Please go ahead.
Matt Taylor:
Hi, thanks for taking the questions, can you hear okay.
David Dvorak:
We can, good morning.
Matt Taylor:
Good morning, thanks. Great. So I just wanted to ask a question about your synergy targets. So you mentioned that you are confident in the 270 number and gave the 135 for the first 12 months. I guess if there is one area that people maybe concerned about is commercial disruptions. So the question is kind of a two part, but really around A; what you think on the commercial side and can you give us any update on your integration planning and how your expectations around commercial outcomes and revenue growth are evolving here as you move towards close? And then two, if we saw upside to the 270, where do you think that could come from?
David Dvorak:
Maybe I’ll take the first part and Jim can respond to the second Matt. I – this has been a multiple month process for us and the tough news about that is it’s long time to have one of these combination spending, the good news side of it is the capability to plan forward has been extraordinarily and both teams on the Biomet and the Zimmer side have done a terrific job of engaging in those planning processes in a manner that I think puts us in an excellent position to move into the execution phase upon closing. And the commercial teams are no exception at all to that we have very detailed plans by territory we made some of the statements upfront because of the nature of the opportunity that we have for cross selling and pulling the product offerings together that we were going to retain every sales position and we stand by that commitment and I would tell you if anything as we get into the detailed planning and the cross selling opportunities get fully characterised, I think those opportunities are every bit as big as what we initially thought and both the revenue the synergies that naturally are going to be part of the integration and the revenue synergy side by virtue of the media [ph] cross sell opportunities are factored into our synergy number that we provided, so that 135 after year one and 270 by year three number is a net number and obviously we continue to be very comfortable that revenue synergy opportunities offsetting some are all the revenue the synergies and then the straight expense synergy element to that nets out to those numbers that we’ve been talking about. And the detailed plans exist is well in the same manner for the operational synergy elements of it, so maybe Jim you could comment on other opportunities beyond…
Jim Crines:
Matt, I would tell you that there will be opportunities beyond the $270 million and we’re getting good visibility to that through the planning process that’s underway. And you know they come in any number of areas including first of all the cross selling opportunities that we’ll have. I think they can very easily be more significant that you know we are planning for at this point. So it’s a question of getting the sales channels trained, getting instrument investments in place, getting the surge in training program up in running that will support those opportunities. There will be, there may not be in the first three years, but we are putting longer term plans in place that would tell you with respect to manufacturing, there will be opportunities to drive some significant savings in manufacturing cost overtime as we sort of rationalise the manufacturing plant network and look to source product from the most optimal notes within that network. And then the you know the other major sort of source of opportunity will be just getting the right structure in place and you know as you know we’ve had experience in working through a very discipline and some layers you know processed in the past that was very instrumental you know when we kicked off were going to improve programs and getting Zimmer on a standalone basis on the right track in just terms of having the right organization in place with the right spend in some layers drive speed at decision making and efficiency. So we are excited about the opportunities ahead
Matt Taylor:
Thanks. Thanks a lot for the details.
Operator:
Thank you. The next question comes from Larry Biegelsen from Wells Fargo Securities. Please go ahead
Larry Biegelsen:
Hi, good morning. Thanks for taking the question. Just two questions from me. First, we know you are focussed on paying down debt as quickly as possible. How should we think about the paydown in terms of years and you know related to that how are you going to use the $3 billion of U.S. cash – gaining to access to that have a favourable impact on accretion in the – and I had one follow up.
Jim Crines:
Larry, this is Jim. First of all the bank, syndicated bank facility that we have in place has a term structure to it. And it requires that first end of that we paid down in each of the first three years I think 15 in the fourth year and the balance in the fifth year. So that’s $3 billion of the total acquisition financing. So we at the very least you know will be paying $300 million down in the first year and potentially more. The – I would tell you when we had talked about that publicly that among other activities you know we’ve been involved in planning in -- planning process that would enable us to get access to the cash being generated at offshore. I believe there is an opportunity to kind of get access to several billion dollars over the next say, five or more years and that will provide the opportunity to perhaps get a share repurchase program reinstated to otherwise might have been able to and you know we’ll provide the management team with an opportunity to head potentially to drive higher accretion.
David Dvorak:
I would tell you that just in terms of how you may be thinking about long term growth in adjusted EPS, that the longer term plan that the management team is putting together with the flip side of combined company, you know we are targeted at the very least growing bottom line earnings in a range of say 10%.
Larry Biegelsen:
That’s very helpful. And second for me you gave underlying Zimmer EPS guidance for 2015 before the impact earlier, should we think about the Q1 sales guidance of 1.5% to 2.5% as represented of the full year 2015, is that kind of what’s implied in the EPS guidance you gave us earlier and I’ll drop next.
David Dvorak:
Well again you know that additional color will be provided after the close of the transaction but it’s fair to say that there’s an expectation that the revenues for the combined entities on a proforma basis, we’ve got to take whatever rent [ph] are required out of the base year but on a proforma basis the expectation would be there will be about a growth sales lets say in at least low single digit.
Larry Biegelsen:
Thanks for taking the questions.
David Dvorak:
Sure.
Operator:
Thank you. The next question comes from Bill Plovanic from Canaccord Genuity. Please go ahead.
Bill Plovanic:
Hi great, thanks, good morning. Thank you for taking my questions. Really if I could I just like to focus on Asia Pac in Japan. I mean you put up a very solid quarter over there and I’m curious how much of the Asia Pac was driven by Japan and then you know obviously when your competitors saw some challenges, how sticky do you think that business will be?
David Dvorak:
Well we’ve been performing well for a good number of quarters in the Asia Pacific geographic segment and Japan is obviously our largest business within that segment. But I would tell you that the growth is very broad based and we’ve done well in other important markets including Australia we’ve done very well in important emerging markets, importantly China in that regard which is a very big business for us over there and a very strategic business as well. So it is broad based and I think as a consequence of that geographic diversity within the region we feel very comfortable that this is a segment that’s going to continue to perform well for us, so if what you are getting at is how much of that is driven by Japan and is that one time I would tell you that I don’t feel like there’s any element of that within Japan that isn’t sustainable for us with the team that we have in place and I don’t feel like there’s an element of Japan driving the regions performance that would cause the regions positive performance to not be sustainable either. We are in a good place within that market and I felt just strongly about Europe, Middle East and Africa’s performance.
Bill Plovanic:
And then for Jim just on the guidance the 620 to 630, you mentioned you had a 20%, $0.20 FX headwind for Zimmer in 2015. Does that 620, to 630 include that headwind?
Jim Crines:
It does. Yes that’s right.
Bill Plovanic:
Okay. Great. Thanks.
Jim Crines:
Okay.
Operator:
Thank you. The next question comes from Joanne Wuensch from BMO Capital Markets. Please go ahead.
Joanne Wuensch :
Good morning and thank you for taking the question. I want to circle back a little bit to what we may think about full year revenue growth to look like on a constant currency basis. Biomet management on their previous their last call briefly mentioned some early the synergies and I think when I speak with investors that topic comes up very frequently recognizing that longer term there obviously are many synergies to be had.
David Dvorak:
Well just in general our expectations as we said in the beginning Joanne is that on a combined basis to grow after market in the range that Jim provided a couple of questions ago is consistent with that. Right now, I think it’s the case for Jim on a standalone basis where we are obviously performing very strong outside the U.S. and there are categories where we are making the right kinds of improvements within the United States, other categories such as hips where we have more work to do. So you know it could be the case that there are some puts and takes to our performance relative to market growth rates once we consummate the transaction and are performing on a combined basis, but we would still expect the combined company in the initial years to perform at market and we believe that we have opportunities where sales for specialization and the innovation pipeline across all opportunities as we progress through the early stages of the execution, integration and get sort of towards the back part of that three year phased integration approach to be able to accelerate to above market rate growth. I guess maybe if – can causes [ph] me to want to just highlight one other point which is there’s a lot of focus about the product category mix and we feel strongly about the strength in the musculoskeletal diversification that comes with this combination. If you look at the non large joint segments, round numbers it will step down as a percentage of the combined company revenues from what Zimmer has on a standalone basis, its 70% to on a combined basis about 60% from large joints or hips and knees. And then we were going to have excellent scale opportunities to be leveraged in other product categories including some of the faster growing areas such as sports medicine, extremities and trauma. So that’s a big opportunity as well to shift the mix by product category to faster growing areas and that’s going to help our topline growth rate. We are very optimistic about our build to realize that potential.
Joanne Wuensch:
Thank you. That fits in perfectly with my second question which is you really did great in spine and dental during the quarter. And selling your products are helping there, but I’m trying to understand since it’s such a change in the previous quarter trajectory, if there was stocking in there or if we just sort of think of this as the start of a new product cycle for those segments?
David Dvorak:
Yes, I think that – true Joanne I think it’s a – it is a bit of a mix of when you describe as it pertains to dental because some of that business is a bit lumpier with stocking distributor orders, but it also is driven by new product introductions. We have a strong regenerative portfolio that we continue to build out and strengthen them, we are completing the Trabecular Metal Dental Implant offering and that’s a premium technology that’s going to help us continue to take share in that market we believe we have the launching in earnest really of the value based implant which is a segment that we’ve had less presence in and a very important segment of that within dental and then we continue to make good progress on our digital dentistry offerings and so we have a lot of product launches and innovations that are hitting the right places within that market. And so I think that our progress there is bright and the future is bright. When you look at the spine performance, we probably had ten or a dozen important product launches in 2014, so that’s the culmination of several years of hard work by that team. We’re rounding out our portfolio, we’ve got a lot of traction in that regard and I would tell you the pipeline in that respect is very full as well, so it’s a game changer for us in the sense of the distribution channel can focus exclusively on Zimmer products as opposed to wrapping other company products as we round up that portfolio and I just think if that’s going to create momentum to sustain a nice top line growth opportunity for us and continue to be able to reinvest and maintain that momentum going forward. So, again we are really optimistic about our opportunities in that $9 billion market and it will end up post closing doubling the size of that business combined with the Biomet spine business, so that’s going to create more opportunity.
Joanne Wuensch :
Thank you.
David Dvorak:
You’re welcome
Operator:
Thank you. The next question comes from Mike Matson from Needham & Company. Please go ahead.
Mike Matson:
Thanks. I just wanted to ask a question that’s actually sort of not related to the merger with Biomet. So you know just based on some of the discussions I’ve had with people in the industry, channel checks, etcetera it sounds like the Persona Knee and I guess just the newer knees in general are seeing some pushback from hospitals because it sounds like what I’m hearing is that both you guys in J&J have tried to get pricing a little bit of a pricing premium and that’s made it difficult to drive the penetration of those new knees. So I’m just wondering if you know do you think things have changed for the industry in terms of new product launches to the point where it is much harder to drive those and command a little bit of a premium?
David Dvorak:
There’s no doubt over the last you know five, ten years the capability to realize benefit from mix has become more challenging. That said, I would tell you that market checks are not consistent with the experience that we’ve had with the Persona launch. Either in the penetration of that product or ability to realize a premium for it and to hold that premium, so we’ve been successful in pricing that the way we think it should be priced, there are variance of the Persona system it is a big system that includes cemented, non cemented and we are working towards other elements in the small type phase launch of the Persona system but we’re continuing to be optimistic and quite confident about our ability to execute the premium prices for the element of the technology that we think were in it.
Mike Matson:
But I guess I just like to challenge out a little because you know looking at the growth rate in knees I mean there hasn’t been much of a differential between the growth that you guys have been putting up and you need a business and change it as well, in fact in some cases we’ve seen better growth in hips from those companies despite having a newer product on the knee side.
David Dvorak:
Well if you look at the performance that we were generating going back pre Persona launch there’s several 100 basis points of transition over and we clearly have been growing at above market rates with their needs for several quarters now since the launch really took hold, so you know that’s a big business for us. We are about a quarter of the market in knees currently and so it takes a lot to move that needle but Persona has moved that needle so we are quite satisfied with the product itself and the execution on the commercial side.
Mike Matson:
Okay, thanks. And then just you know the growth rates have slowed I guess for both you and Biomet and so I was wondering if you and do you believe that there has been any disruption ahead of the deal you had spent sort of a long time coming and that’s probably created some uncertainty among employees and sales people.
David Dvorak:
Well naturally I mean there’s a long tendency period but I think if you look at the company’s overall performance Zimmer’s that is you see a stable performance I think that in markets where you are reliant upon an independent distributor network that uncertainty could lead to a pause on certain actions in investment in particular but I would tell you we’ve been tracking the attrition rates very carefully and have not seen a spike up in that so I think that we are entering the closing period for planning and moving towards consummating the deal and then to the execution of the integration in a very good position to create moment momentum right out of the blocks.
Mike Matson:
All right. Thank you.
David Dvorak:
Welcome.
Bob Marshall:
Julia, we have time for one additional question.
Operator:
Thank you. The last question comes from Glenn Novarro from RBC Capital Markets. Please go ahead.
Glenn Novarro:
Hi. Thanks for squeezing me in here. Two broader questions on the overall U.S. knee and hip market and I apologize if you've already addressed this. I've been jumping around conference calls this morning. If I look at the U.S. market in the fourth quarter, Biomet, J&J, Stryker, you guys all came in a little light. I understand it's a tough comp, but I'm wondering if you have any other thoughts or commentary as to why maybe 4Q did come in a little light across the board, at least relative to Street expectations. Is there any chance -- because 3Q came in better -- is there any chance maybe we pull forward some cases in 3Q? So commentary there. And then, in your prepared remarks, you said your outlook for knees and hips for 2015 was up, but can you -- is that U.S? Is that worldwide? Is that units? And then any guidance on pricing for 2015? Thanks
David Dvorak:
The knee and hip markets on a global basis have performed in a very consistent manner over the last couple of years. If you look at its probably closer to 3% growth rate in 2013 and that was positively impacted most importantly by the uptick in the U.S. hip and knee business market within the fourth quarter of 2013. The growth rate for knees and hips on a global basis in 2014 looks like it is close to that same number, maybe 2.5% as opposed to 3 the close to that same number and I think that you’re just going to see stability around that kind of a number on a global basis. The real difference maker in the quarter itself, the fourth quarter of 2014 that is – is infact the U.S. business where you know those markets look like they were growing not just at low single digits but upper single digits in the prior year comparison that is the fourth quarter of 2013. For Zimmer’s business we grew hips mid-single digits and we grew knees low double digits in that quarter and so you just run through the map on that front, Glenn it really does produce a market comp that is much of the explanation for why the market looks a little bit choppy maybe going from Q3 to Q4, but I think overall you want to focus on kind of a two year trend along the lines of what I was describing at the beginning of the reply.
Glenn Novarro:
Okay. And then the guide or your assumptions for 2015, again, you gave it to me, gave it to us on the call I just want a little more clarification, knee and hip growth is going to be up according to commentary is that U.S. worldwide and what was the pricing assumption for 2015?
David Dvorak:
Glenn, I think that the overall musculoskeletal market is probably what we were intending to reference with something that approaches mid-single digits because you have some faster growing subsets right within the musculoskeletal market. I think that the growth rate for knees and hips I would estimate along the lines of what I was just describing you know kind of a net 3 percentish range. And then as it relates to price we guided for the first quarter in a very consistent manner with going into 2014 expecting minus 2% to minus 3%. We ended the year at minus 2.4% so we don’t see that climate changing in any material way in the first quarter and you could extrapolate that as a view as to what we would expect to see in 2015 at this point.
Glenn Novarro:
Okay. Great. Thank you.
David Dvorak:
You’re welcome.
David Dvorak:
So with that I’d like to thank everyone for joining the call today and for your continued interest and support for Zimmer. We look forward to speaking to you on our first quarter conference call which is scheduled for 08:00 am on April 30. With that, I’ll turn the call back to you Julie.
Operator:
Thank you again for participating in today's conference call. You may now all disconnect.
Executives:
Bob Marshall - VP of IR David Dvorak - CEO Jim Crines - CFO
Analysts:
Bob Hopkins - BofA Merrill Lynch Matt Miksic - Piper Jaffray Mike Weinstein - JPMorgan Matt Taylor - Barclays Capital Joanne Wuensch - BMO Capital Markets David Roman - Goldman Sachs Kristen Stewart - Deutsche Bank Derrick Sung - Sanford C. Bernstein & Company David Lewis - Morgan Stanley
Operator:
Good morning. I would like to turn the call over to Bob Marshall, Vice President, Investor Relations and Treasurer. Mr. Marshall, you may begin your call.
Bob Marshall:
Thank you, Britney and good morning everyone. Welcome to Zimmer's Third Quarter 2014 Earnings Conference Call. I'm here with our CEO, David Dvorak and our CFO, Jim Crines. Before we start, I'd like to remind you that our discussions during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties. Also, the discussions during this call will include certain non-GAAP financial measures. Reconciliations of these measures to the most directly comparable GAAP financial measures are included within the earnings release, which is available on our website at investor.zimmer.com. With that, I'll now turn the call over to David.
David Dvorak:
Thank you, Bob. Good morning, everyone, and welcome to our earnings call for the third quarter of 2014. This morning, I'll review our third quarter financial results, providing commentary on the year's progress to date and highlights from our performance. Jim will then provide additional financial details. I'll state all sales in constant currency terms and all earnings results on an adjusted basis. Zimmer drove solid topline growth across several key product categories and geographies in the third quarter notably, accelerating U.S. knee sales over a strong performance in the prior year. Consolidated net sales for the quarter were $1.11 billion, an increase of 3.1% and our earnings per share were $1.35, an increase of 8% over the prior year period. In the third quarter, Americas sales grew by 1% year-over-year, while Europe, Middle East and Africa increased by 5.7%, and the Asia Pacific region grew 6.9%. These results reflect focused execution amid a stable global market for musculoskeletal solutions, with some modest acceleration in certain geographies. With respect to pricing, we experienced price pressure of negative 2.2% in the third quarter, increased global market penetration of new products, positive long-term clinical validations of our legacy products in key international markets and the natural cycle of contract renewals and renegotiation in the United States all contributed to a sequential improvement and negative price trends by 60 basis points and thanks to the ongoing success of our operational excellence initiatives in the quarter, we once again expanded operating margins and accelerated earnings growth. We also made progress with integrations planning for our pending combination with Biomet. We continue to be excited about the compelling strategic and financial rational, underlying this combination. In addition to commercial and operational synergies, our combined entity will posses enhanced capabilities and resources for research and development, allowing us to more rapidly and efficiently bring a broad portfolio of musculoskeletal products, technologies and services to market. We remain focused on integration planning efforts around the transaction, which we expect to close in the first quarter of 2015. Turning now to our product categories, Knee sales for the third quarter increased 6.3%, which we believe was an above-market performance, reflecting positive volume and mix of 9.2% and negative price of 2.9%. Our Americas segment reported a sales increase of 5.7%, while Europe, Middle East and Africa grew by 9.8% and the Asia Pacific region delivered 3.8% growth compared to the prior year period. Throughout the quarter, our focused execution drove solid sales of our next gen knee replacement system in European markets and supported the achievement of milestone sales for Persona, the personalized knee system, which has now surpassed the total of 100,000 implantations since its commercial introduction. As we've communicated in previous quarters, the Persona system offers unprecedented level of anatomic fidelity and next generation features and is supported by Zimmer's intelligent instrumentation systems, including patient-specific instruments, the iASSIST Personalized Guidance System and the eLIBRA Dynamic Knee Balancing System. We also continue to be excited about the steady growth of our joint preservation portfolio, including our single injection Gel-One Cross-linked Hyaluronate treatment and the Knee Creations' Subchondroplasty procedure. Earlier this month, we strengthened this growing biologics portfolio of differentiated treatments early joint disease through the acquisition of Cambridge Massachusetts-based ETEX Holdings, Incorporated and its innovative line of solutions. Zimmer's hip business recorded a sales increase of 2.7%, reflecting positive volume and mix of 5.2% and negative price of 2.5%. These results include a 0.2% sales decrease in the Americas; a sales increase of 2.8% in Europe, Middle East and Africa; and an impressive 9.7% increase in the Asia Pacific region. We continue to position a comprehensive hip portfolio, for long-term growth opportunities and in the quarter, we achieved above market performances in several key overseas markets. Global sales were led by premium solutions such as our Continuum Acetabular System and BIOLOX delta Ceramic head offering. We also delivered steady growth in the Americas with our M/L Taper and TM Primary Stems as well as the Avenir Müller Hip Stem in the European markets. Our legacy hip portfolio continues to demonstrate excellent performance as evidenced by an impressive level of clinical and scientific validation. Zimmer continues to achieve favorable ratings by the United Kingdom's Orthopedic Data Evaluation panel with 10 of our major hip brands having now obtained a Class A 10-year rating. Additionally, in ongoing extensive laboratory testing, Zimmer's Vivacit-E Vitamin E Highly Crosslinked Polyethylene liners have been evaluated for more than 90 million cycles of wear testing. We believe this to be the first and only hip replacement technology to demonstrate long-term wear resistance, surpassing the number of walking steps a patient will typically take during their life time following total hip replacement surgery. Turning to extremities, Zimmer recorded a sales increase of 2.5% in the third quarter. Competitive pressure continue to present a headwind for our shoulder business in the U.S., which somewhat offset our double-digit growth in the Europe, Middle East and Africa and Asia Pacific regions. We'll continue leveraging our differentiated shoulder portfolio including the Trabecular Metal Reverse Shoulder and the Patient Specific Instrument shoulder system and innovative surgical platform that further enhances our position in this rapidly growing segment of the shoulder arthroplasty market. We'll also continue to drive sales contributions from our more recently introduced products in our extremities portfolio such as the Trabecular Metal Total Ankle system and the Nexel Total Elbow, both of which feature advanced proprietary bearing technologies. Zimmer dental sales decreased by 2% in the third quarter. Our stabilizing performance in the Europe, Middle East and Africa region was offset by challenging year-over-year sales comparisons for our Asia-Pacific business and regenerative portfolio. We expect that these headwinds in the quarter will normalize in future operating periods and will continue to focus on leveraging our comprehensive dental portfolio for improved growth. Zimmer trauma sales decreased 0.6% in the third quarter with an impressive 9.4% sales increase in the Asia Pacific region, offset by a 5.5% sales decrease in the Americas and a 0.7% decline in Europe, Middle East and Africa. Although we faced challenge in prior year comparisons in Europe, Middle East and Africa, we continue to achieve encouraging growth in the Asia Pacific region and steady adoption of our core offerings, including rising sales of the Zimmer Natural Nail family. In building on the recent launch of the Distal Radius Plating System in the United States, in the third quarter we introduced this versatile fracture system in certain European markets. We intend to position our differentiated trauma offerings for improved growth in the future as we continue expanding our footprint in major trauma centers around the globe. Zimmer spine delivered 6.4% sales growth over the prior year, which we believe is an above market performance. The growth of this global business continues to validate our efforts and focus on core fusion solutions. As we execute on an innovative and increasingly competitive spine portfolio, released in the second quarter of 2014, the Virage OCT spinal fixation system has already succeeded in expanding our footprint in posterior fixation surgeries, while supporting volume and mix growth for other Zimmer spine products used in the same procedures. We've also been pleased with the ongoing commercialization of the Optio-C interior cervical system. Our next generation modular cervical device, which in the third quarter received an additional 510-K clearance from the FDA for its allograft application. Sales for Zimmer's surgical and other category decreased by 4.4% in the quarter. We continue to face challenging sales comparisons in the U.S. stemming from the exceptional performance in capital sales of our differentiated Transposal fluid waste management system in the prior year. However, we drove noteworthy sales across a number of major product lines, including consumable and wound debridement products as well as skin graft solutions. We also continue to achieve healthy growth in capital sales of the A.T.S. family of Automatic Tourniquet Systems, which feature advanced proprietary pressure sensing technology designed to achieve higher levels of safety, reliability and convenience. We look forward to continuing to drive this differentiated portfolio for growth in future quarters. With that, I'll now ask Jim to provide further details on the third quarter and our guidance. Jim?
Jim Crines:
Thank you, David. I will review our third quarter performance in more detail and then provide additional information related to our updated 2014 sales and earnings guidance. Before I start, I would like to note that our results reflect the same number of billing days in the current year quarters than the prior year. Our total revenues for the third quarter were $1,106,000,000, a 3.1% constant currency increase compared to the third quarter of 2013. Net currency impact for the quarter decreased revenues by 0.2% or $2 million. The negative currency impact for the quarter related principally to our Japanese yen-denominated revenues, partially offset by positive currency translation associated with our euro-based revenues. Our adjusted gross profit margin was 73.4% for the quarter. The margin ratio declined 10 basis points compared to the third quarter of 2013. In the third quarter, we recognized approximately 80 basis points of charges related to the medical device excise tax. This headwind, along with ongoing but more moderate price pressure was effectively offset by manufacturing efficiencies, as well as modest incremental gains from our cash flow hedging program and reduced year-over-year excess and obsolescence changes. The company's R&D expense decreased 6.7% or $3.3 million to 4.2% of net sales when compared to the prior year. The decrease in R&D expense continues to reflect focused efforts on our quality and operational excellence initiatives and related dedication of resources. Selling, general and administrative expenses were $443.5 million in the third quarter and at 40.1% of sales, were 70 basis points below the prior year. The continuous improvement in this ratio reflects our ongoing commitment to administrative and operational excellence. Our global strategic sourcing initiative as well as go-to-market and distribution optimization efforts continue to drive improved productivity and year-over-year savings in certain spend categories. In the quarter, the company reported pretax charges of $66.9 million in special items; $3.8 million in cost of products sold pertaining to global restructuring, quality and operational excellence initiatives and recent acquisitions; and $10.5 million of interest and upfront financing cost associated with the pending Biomet transaction. Adjusted third quarter 2014 figures in the earnings release exclude the impact of these charges. Adjusted operating profit in the quarter amounted to $321.9 million or 29.1%. Our adjusted operating profit-to-sales ratio was 100 basis points higher than the prior year third quarter. The continued expansion of operating margin demonstrates the organization's commitment to create value through the achievement of operational efficiency goals along with the growth and capital allocation dimensions embedded within our value creation framework. Net interest expense for the quarter amounted to $13.3 million, which was flat when compared to the prior year quarter. Adjusted net earnings were $232.6 million for the third quarter, an increase of 7.8% compared to the prior year. Adjusted diluted earnings per share increased 8% to $1.35 on a 171.7 million average outstanding diluted shares. These adjusted earnings per share are inclusive of approximately $0.05 of share-based compensation. At $0.96, reported diluted earnings per share increased 6.7% from the prior year third quarter reported EPS of $0.90. Our adjusted effective tax rate for the quarter was 24.7%, which is 70 basis points favorable when compared to the prior year due to a favorable change in estimate associated with certain income tax returns that were finalized in the quarter. Our reported effective tax rate for the quarter was 27.3%, due mainly to certain non-deductible expenses connected with the pending Biomet merger. The company had approximately 169.3 million shares of common stock outstanding as of September 30, 2014, a decrease compared to the 170.5 million as of September 30, 2013. Operating cash flow for the quarter amounted to $255.7 million, a decrease of 12.6% from $292.7 million in the third quarter of 2013. The decrease was driven primarily by higher tax payments relative to the same period prior year as well as increased inventory investments in support of higher field consignments in global new product launches. Net inventories were $1.2 billion at the end of the third quarter, an increase of $30.3 million from June 30, 2014. As I just noted, the increase is connected with the ongoing global commercialization of new product offerings, as well as the effects of placing more inventory into distributor and hospital consignments. Adjusted inventory days on hand finished the quarter at 348 days as compared to 284 days at the prior year quarter end. As of the end of the third quarter, net receivables increased to $947.6 million from $898.9 million in the third quarter of 2013 or 5% above the prior year. Our adjusted traded accounts receivable days sales outstanding finished the quarter at 71 days, two days improved when compared with the prior year. Depreciation and amortization expense for the third quarter amounted to $90.9 million. Free cash flow in the third quarter was $172.5 million, $33.5 million lower than the third quarter of 2013. We define free cash flow as operating cash flow less cash outlays for instruments and property, plant and equipment. The decrease in free cash flow was driven by decreased operating cash flows, as I've just noted as well as increased instrument investments in support of the ongoing launch of new products. Capital expenditures for the quarter totaled $83.2 million, including $50.9 million for instruments and $32.3 million for property, plant and equipment. I'd like to turn now to our guidance for 2014. In our earnings release this morning, we updated the company's expectation for 2014 revenues and now forecast revenues to increase approximately 2.25% constant currency when compared to 2013. We now expect foreign currency translation to decrease our reported 2014 revenues by approximately 0.75% for the full year. Therefore, on a reported basis, our revenues are projected to be approximately 1.5% above 2013 results. As we anniversary through the recognition of medical device excise tax during the fourth quarter, coupled with ongoing savings from our operational excellence programs we would expect the gross margin ratio for the year to remain between 73% and 74%. Our guidance for R&D, SG&A and interest expense for the full year also remains unchanged. However, as you refine your models for the fourth quarters, please consider the seasonally lower expense ratios typically experienced in the fourth quarter. Moving down the income statement, the estimated full year tax rate is now between 25% and 25.5%. The previously guided fully diluted share count of 172 million shares to 173 million shares is more likely to be toward the lower end of that range as exercises some employee stock option are lower. In the fourth quarter, we would expect fully diluted shares to be just above 172 million shares. Full year 2014 adjusted diluted earnings per share guidance has been updated to approximately $6.05, taking into account our updated expectations for full year revenue growth. As indicated in our earnings release, to arrive at our anticipated reported GAAP earnings per share, you should subtract total charges for special items and certain claims of $250 million and $70 million of Biomet transaction-related expenses on a pretax basis or approximately $1.40 per share. Before I finish, I would like to make a few modeling comments relating to our proposed combination with Biomet. I want to reiterate that the previously announced guidance regarding accretion and adjusted cash earnings per share applies to the first 12 months following the closing of the deal. With that in mind, we continue to expect accretion and adjusted cash earnings per share to be $1.15 and $1.25 on approximately 207 million fully diluted shares. To arrive at this fully diluted share count, and the 32.7 million shares comprising the equity portion of the consideration for the deal through our projected pending diluted share count of approximately 173 million as well an additional 1.3 million shares anticipated to the issue pursuant to our employee equity programs. Finally, please note that our guidance does not include any impact from any unforeseen events. David, I'll turn the call back over to you.
David Dvorak:
Thanks, Jim. Zimmer's third quarter was highlighted by solid sales across key products and geographies. Our performance continues to be driven by innovative systems such as the Persona need, which incorporates premium technologies that we leverage across our differentiated portfolio, including Trabecular Metal technology in the Vivacit advanced bearing material. For the balance of 2014 we'll be committing significant energy to the ongoing integration planning for our pending combination with Biomet, while continuing to deliver a compelling value proposition, the patients providers and healthcare institutions in the 45 billion musculoskeletal market. And now I'd like to ask Britney to begin the Q&A portion of our call.
Operator:
Ladies and gentlemen, we will now begin the question-and-answer session. (Operator Instructions) Our first question comes from the line of Larry Biegelsen with Wells Fargo Securities. Please go ahead.
Unidentified Analyst:
Hi guys, it's actually Craig on for Larry.
David Dvorak:
Hello Craig.
Unidentified Analyst:
Just I guess, I'll start with the implied -- the implied growth by my math is about 2% in Q4 and I just wanted to know and it seems like a bit of a slowdown, especially some of the -- given some of the acceleration you saw in re-con and then some of the seasonality trends that we expect. So I just wanted to know what headwinds or what factors make that number seems conservative to us at least?
David Dvorak:
Well I think that you point out the seasonality trends and I think that's the thing to focus on. We wouldn’t expect our performance to fall off relative to the market and these categories the positive trends will continue by product category and by geography and we look to continue to improve the sales execution in the Americas in particular. But as you reflect back on the fourth quarter of 2013, it was a pretty significant procedural shift into their quarter and that really was the area that one has to be careful about as we look to project Q4 market growth rates within the United States on the large joint side in particular.
Unidentified Analyst:
Okay. Thanks. And if I can as a follow-up just ask on pricing, obviously you guys -- pricing improved during the quarter and I appreciate the color on some of the timing of contracts, but other competitors have seen pricing pressure increased during the quarter and throughout the year. So I just wanted to get your sense of how we should look, how we should look at that going forward?
Jim Crines:
Sure Larry, this is Jim.
Unidentified Analyst:
Craig.
Jim Crines:
Craig, sorry.
Unidentified Analyst:
We have a problem.
Jim Crines:
Yes, yes. First of all we're really pleased with the sequential 60 basis point improvement in negative price in the quarter. We continue to believe our commercial teams are doing a good job with managing the pressure. As David indicated, there are a number of factors contributing to the [rate] (ph) we saw in the trend. As an example, as we establish higher market penetration with new products, including most importantly the Persona knee system, we tend to see more stability in prices because these new platforms are being introduced with tighter price bands compared with our more established legacy products. As you know we're operating in a market environment that does not allow for the kind of variations we might have experienced in the past. With regard to contract renewals, we have had to deal with our fair share of demand letters from our U.S. based hospital customers. In our case the total value of price concessions by quarter across all contract renewals has come down sequentially from one quarter to the next beginning with the second quarter. Now we may see an increase in demand letters in coming quarters, we certainly expect price pressure is going to continue in this market, but still a positive trend in this quarter and one we believe is helped by increased market penetration of new products. And then lastly, I would just point out that we saw improvement in all geographic segments in the quarter as compared with the second quarter and in this context, we believe the continued positive long-term clinical validation supporting our legacy products, which is demonstrated in registry data, is helping us in key international markets.
Unidentified Analyst:
Great. Thanks guys.
David Dvorak:
You're welcome, Craig.
Operator:
Thank you. Our next question comes from the line of Bob Hopkins with BofA Merrill Lynch. Please go ahead.
Bob Hopkins - BofA Merrill Lynch:
Thanks and good morning.
David Dvorak:
Good morning.
Bob Hopkins - BofA Merrill Lynch:
So, on the Biomet transaction, thanks for the detail, I just wanted to ask two things. First sort of qualitatively I was wondering David, if you could comment on how the integration is going generally or how the early part of the integration is going generally? Are you having good conversations with the distributors? Just your confidence level and then may be Jim more quantitatively I appreciate your comments on the synergies and the share count and frankly that's the kind of thing that I think a lot of people are modeling and as I see the street consensus for 2015 on a cash basis, assuming that Biomet closes in Q1, is in the high $7 area, $7.80, $7.85 somewhere in that range. And I was just wondering if you could comment on is that a number that you are -- is that a range that you're relatively comfortable with at this point, given the -- given what you're seeing in the business today.
David Dvorak:
I'll pick up with the first part of your question Bob. This is David. We're very, very pleased with the integration planning as it relates to the combination. I'll tell you that the chemistry of the Group has been terrific. The energy level has been extremely high. We've had opportunities and part of this is enhanced by the sort of the co-location benefit of the headquarters, but I would tell you globally leaders have set a very good tone, a very constructive tone of the integration planning work and that's cascaded down as these teams have expanded. At all levels of the organization I think that part of that is just a credit to the leadership and the Biomet leaders in particular, I want to applaud their efforts. It's very commendable the approaches they take, but I would tell you that the other element of it that one can't fake at some level, is just the underpinnings and premises for the deal are unmistakable to folks as they get into the planning and look at the benefits of combining these portfolios, combining the R&D efforts, the strength of the combined distribution channels and on and on, one can clearly see that this is going to be a leadership position that can make a big difference for all stakeholders involved. And that is establishing the positive tone in combination with the approach that the leaders are taking. So we're right on track if not ahead of the planning efforts relative to what we were anticipating or looking to achieve going back to the announcement date in April and on the distribution side in particular, that you referenced/ I think that's not really well because at the sales level they can see the benefits of the combined portfolios and they can understand the logic to the combined R&D efforts and what a difference that can make in the environment that we're going to be operating in and the differentiated opportunity that we're going to have to provide better solutions to enhance patient outcomes and to do that in an increasingly cost efficient for the customers and help shape how those solutions are delivered to the marketplace. So all is on track if not ahead of schedule and then I would tell you that the tone and the attitudes are even more positive than what I had hoped for.
Jim Crines:
And Bob, this is Jim. Understanding that we have not provided top and bottom line guidance for calendar year 2015, we'll do that the closing of the deal for the combined enterprise. Ahead of that, we would plan to continue to provide guidance on Zimmer on a standalone basis. I will say that we understand there is a wide range of estimates that are out there for the combined enterprise, some of which may assume that the closing takes place early in the first quarter, other that may assume the closing take place later in the first quarter and that range will certainly tighten as we provide more specific guidance. I am not at all uncomfortable. I think by and large the analyst community has taken the $1.15 to the $1.25 in accretion and cash earnings per share and build that into the assumptions that they're making at this stage.
Bob Hopkins - BofA Merrill Lynch:
Okay. So there is nothing that you would point out that would things that we would need to consider as modeling in that sort of a range. Do you think we're missing any major piece as it just comes down to the timing of the close and so I am just trying to get a sense from you, are there things that you think we're not considering that we should be?
David Dvorak:
Well again, the timing of the close is a pretty big assumption of whether or not you assume it's going to be at the beginning or the end of the first quarter and we provided a bit more detail on average shares in my scripted comments. It's not something we had done earlier and are doing that in an effort to provide as much sort of detailed support as we can at this stage.
Bob Hopkins - BofA Merrill Lynch:
Okay. Great. I'll leave it at that. Thanks very much.
David Dvorak:
You're welcome, Bob.
Operator:
Thank you. Our next question comes from the line of Matt Miksic with Piper Jaffray. Please go ahead.
Matt Miksic - Piper Jaffray:
Thanks for taking the questions. One, a couple, just one clarification and then one follow-up. You talked a little about pricing in the quarter, and some of the trends that sort of affected this year so far. And I think Craig mentioned some of the other commentary that we've heard throughout the year. But I'd love to get your sense as to, is the stability that you're seeing with, I'm assuming Persona, some of your new products, and sort of the -- I don't know, maturation of the hospital networks in the U.S. and their cost control strategies that we've seen evolve over the last years, is that something that you expect to be converging downward from where the pricing pressure that you're seeing? Or is this low 2% pricing pressure something you see as sustainable? I know it's kind of a difficult thing to predict, but maybe just in terms of new activity, changes in the way hospitals are buying, is there anything that you're seeing that would indicate that this is not a sort of sustainable range over the long term? And then I have one follow-up.
David Dvorak:
We would see that the current trends as being stable and nothing environmentally changing in a material way Matt that would cause us to at this point believe that the future shorter and intermediate term will look materially different. If you reflect back on the guidance that we came into the year in our January call, we said that we were expecting 2% to 3% negative price in the year and Q1 was minus 2.3%, Q2 was minus 2.8%, Q3 minus 2.2%. So very tight within that band and more importantly and substantively to your question, the activities that surround those dynamics are consistent with expectations. So holding to that same band for the balance of this year, will give you some specific guidance and color as we get into next year and provide 2015 guidance, but nothing that we see right now would cause us to believe that the environment is going to change dramatically.
Matt Miksic - Piper Jaffray:
That's great. Thank you, David. And a follow-up for Jim, if I could. You mentioned a few, it sounded like a handful of sort of positives in the gross margin line. But the margin was in fact down a touch year over year. If you could just maybe help us understand how those factors kind of added up to a slight decline, and what we can expect kind of heading into the end of the year?
Jim Crines:
Sure, well understand coming into the year, we're taking into 80 basis points of headwind associated with the medical device excise tax. So the positive things that I mentioned that efficiencies, we're getting out of our operational excellence initiatives the slightly higher gains on hedge contracts as well as lower excess and obsolescence starters in the quarter -- third quarter this year compared to the third quarter of last year all helped to offset that 80 basis points of headwind, so that the gross margin ratio was only down 10 basis points compared to the prior year.
Matt Miksic - Piper Jaffray:
And then heading into the end of the year, any seasonal expectations you can sketch out for us.
Jim Crines:
Well I would tell you we're obviously taking -- we've increased our guidance with respect to the currency headwind for the fourth quarter. That does typically result in somewhat higher gross margin ratio as we realize gains on hedge contract and a lower topline on -- reported topline on our international revenues. That together with what we were just talking about in terms of more moderate price pressure, I would tell you sort of contribute to gross margin expectation for the fourth quarter that would put us toward the high end of the range of what we're guiding to for the full year.
Matt Miksic - Piper Jaffray:
Got it. Thank you, Jim. Thank you, David.
Jim Crines:
Welcome.
David Dvorak:
You're welcome, Matt.
Operator:
Thank you. Our next question comes from the line of Mike Weinstein with JPMorgan. Please go ahead.
Mike Weinstein - JPMorgan:
Thank you. Let me start with the 2% to -- sorry, the 2.25% revenue guidance for the year. Maybe just give us your thoughts, and obviously you're not guiding yet, but if you think about the Company pro forma for Biomet. Biomet grew just this last quarter organically if you adjust for their acquisition, slightly faster than that. Can you just talk about how you think about revenue growth at this company pro forma? And then I was hoping you could spend a little bit of time on the money you're setting aside to lock in distribution. If you could tell us a little bit more about that, and how expensive it will be, that would be great. Thanks.
Jim Crines:
Sure. Mike, this is Jim. I would just go back to the guidance we provided when we announced the deal and expectation that in the short term, the combined enterprise we would expect to be growing in line with market understanding that there could very well be some disruption. The sales channels are getting integrated, but just believe that we have significant opportunities with respect to cross selling that can offset any revenue loss that we might experience as the sales channels are being integrated. Now as what the market growth will be globally in 2015, we'll provide some color on that when we come out with 2015 guidance somewhere in the range of low to mid single digits, but will be more specific about that when we come out with that guidance in January.
Mike Weinstein - JPMorgan:
And then on the money set aside, I think in the proxy, Jim or David, whoever wants to take this. I think there was $87 million set aside for what I think it was classified as distributor and management retention. Can you just talk about how extensive basically the pay-to-stay will be, and the agreements that you are coming to with some of the distributors? What is the one-year agreements, two-year agreements? If you could give us some visibility on that, that would be great?
David Dvorak:
Sure, and all integration planning is ongoing at this point in time Mike. I think that the disclosure that you're referencing the plans that were put in place by Biomet and so that disclosure is a specific I guess there's anything that is out there publically. Those were programs that were designed really pursuant to the negotiation process and the diligence process and we were very supportive of, but Biomet management and Board's decision to put those programs in place, I think that they continue to serve that entity well from whatever we can see within the market place. The balance of the cost of those integrations are just lumped up at this point in time and the best estimates that we had at the time of the announcement Mike is what the integration cost would be and just -- we put that out there as just being a certain multiple of the anticipated net synergy benefits. But we will be able to firm up those numbers as we lock down the plans and I would be really confident that by the time the closing rules are around, we're going to be able to give you a really specific guidance as to what the all-in integration numbers are going to look like and the pace of retrieving the benefits of the synergies etcetera.
Mike Weinstein - JPMorgan:
Okay. I would just say that as you guys get closer to it, if you could try and give the street just some visibility into the types of agreements you're reaching with the distributors and that would obviously help us gain some comfort in the synergy risk that everybody's been talking about.
David Dvorak:
Yeah. Noted Mike we'll do that consistent with the lockdown of those plans okay.
Mike Weinstein - JPMorgan:
Perfect. Thank you, guys.
David Dvorak:
Thank you.
Operator:
Thank you. Our next question comes from the line of Matthew Taylor with Barclays Capital. Please go ahead.
Matt Taylor - Barclays Capital:
Hi. Thanks for taking the question. I wanted to ask one just about the integration and the performance this quarter. So I guess one of the trends in the quarter and recently, is some of those non-recon businesses that you have, have been growing more slowly. The hip and knee businesses had a pretty good quarter this quarter. But you referenced before you see a lot of cross-selling opportunities, and I guess can you talk about the differences that you see between combining the large recon business versus combining some of those other ones? Do you expect more commercial synergies at those other businesses that may be sub-scale at Zimmer and Biomet?
David Dvorak:
Yeah that’s a great question. I would tell that if you look at the portfolios, there are significant opportunities in all product categories Matt. I think that the complementary natures within large joints might from the outside world appear to be a bit more nuance because both of these companies have fairly comprehensive portfolios to begin with. But those nuances can make a big difference to the sales force as well and I’ll tell you some of the product fares that we've had consistent with the diligence and integration planning have revealed opportunities that have the sales forces on both sides very excited within the large joint side. It really takes on a bit of different dimension when you get into the smaller business that your reference however because those businesses for each company have been challenged by scale historically and when you bring the product portfolios together on day one, you have some really significant enhancements whether material gaps that get filled. But then very, very importantly there are kind of couple of big benefits to the combination as it relates to those business that include the capability to have much more scale or R&D pipeline so the cadence of what's going to come out of the development effort is going to be much, much more regular for those smaller business. We're going to be able to get to the point where we have scale very competitive portfolios and then we were reinvesting in those portfolios and keeping the sales force engaged, excited, and getting out of ahead rather than filling gaps, which is kind of the trap the end up stuck within subscale. So I think that dynamic changes in a very material way. And then secondly, the thing I would point you to just the capability to build out specialized sales forces at the rep level for instance in those different product categories, which again historically because of the scale challenges has been difficult for either company to do fully. But we really do see our way towards being able to build out specialized sale forces of the rep level wherever that makes sense wherever that customer call point justifies that kind of an investment. So that's going to put us in a much stronger position. The combined product bag and the focused sales force is going forward.
Matt Taylor - Barclays Capital:
Thanks. And just a follow-up on price. I think everybody assumes that pricing will stay down, or potentially get a little bit worse in the future. Do you see any scenario where in large joint recon, for example, pricing could get better because of either new products and mix, or because pricing has been down for the last five years.
David Dvorak:
Well I think that you could see some evidence of some anniversarying out of some of those trends that have created the pressure. I just think it's premature to project things going into positive territory. I think that the stability message is the one that we would use or refrain at this point in time, but the scenario that you put out there is a possibility of some point in the future.
Matt Taylor - Barclays Capital:
Okay. Thanks a lot.
David Dvorak:
You are welcome.
Operator:
Thank you. Our next question comes from the line of Joanne Wuensch with BMO Capital Markets. Please go ahead.
Joanne Wuensch - BMO Capital Markets:
Good morning. And thank you for taking the question. You had some really outsized growth rates in certain regions, if you could just comment on that. In hips it was up almost 10% in the Asia-Pacific region, in knees, EMEA up almost 10% also. What's going on there?
David Dvorak:
Those teams are really doing a great job Joanne with sales execution. So largely the same portfolio, same competitors, the local dynamics can be a bit difference, but I don’t think those should be categories as being material. Those sales teams are just doing an excellent job on the execution side and that is in the first quarter that we have seen that. In Q2 you saw the same very strong knee performance coming out of Europe, Middle East and Africa as well as the very strong hip performance coming out of Asia Pacific. So those cross earnings are the types of things that we wanted to transfer back to other markets and I think the big positive that one should take away from that and this is what we communicate internally to the teams is you have the portfolio necessary to compete effectively. But look, some of the trends that you saw within the United States Market sequentially from Q2 to Q3 show some important improvement in these categories as well, a pretty significant step up in knees for example and slight improvement in hips. So we are going to keep working forward and try to post some numbers on the broad that look consistent with that high-end performance for Asia Pacific on hips and the high end performance for EMEA on knees.
Joanne Wuensch - BMO Capital Markets:
And then in terms of the merger, could you remind us of when the deadlines are for various regulatory rulings? And then if there's any way to give us some qualitative update on how those conversations are going that would be appreciated. Thank you.
David Dvorak:
Sure. The timelines that we put on and updates publically are what there is to say about that formally. You know there is a bit more of a formalized chronology that's been put out between now and the coming weeks and through the month of March even in the case of the European filing. The U.S. process is ongoing a little bit more of a rolling basis. We're making a good progress and I think I would just say by way of general characterization is that process is tracking absolutely consistently with the diligence that we did prior to announcing the deal and what we are articulated at the time of the deal announcement back in April. So everything is running on course and from a timing prospective consistent with our expectations leading us to just reiterate that we have the belief that we will close the deal in first quarter of 2015.
Joanne Wuensch - BMO Capital Markets:
Thank you.
David Dvorak:
You're welcome.
Operator:
Thank you. Our next question comes from the line of David Roman with Goldman Sachs. Please go ahead.
David Roman - Goldman Sachs:
Good morning, everybody. And thank you for taking the questions. I was hoping to start with the spine business because that was, if I look across the drivers of the acceleration this quarter, knees was certainly a call-out, but spine also was a very nice pick-up. David, if I go back to your comments on the success you're having with Virage and the pull-through you're getting, could you maybe just put that in a little bit more context about where you are and sort of the full building out of your spine product portfolio? And whether you're at a point that the product bag is competitive, and we can see this type of trajectory continue?
David Dvorak:
Sure David. First when we just say we're thrilled to get a question this quarter on spine. We're really proud of the team. This is the team that’s been together for several years. They are the ones that develop a very intelligent strategy and approach to running that business and importantly to what they were going to focus on by way innovation. Largely that team has been focused from a development effort on the core fusion market and they’ve just been methodically and dogged in executing those plans and at the same time strengthening the distribution channel. So I believe that what you saw in Q3 is a shape of things to come by the spine division. And we're probably in the mid innings of building that portfolio out at this point David and you're seeing just the beginnings of the benefits of them executing that strategy with these products rolling out. We have about a dozen product launches this year. So a really robust pipeline that has been a combination of pure internal and some mix of external development through licensing and distributional arrangements, but the primary drivers have been the internal projects that include projects like Virage and the benefit of those systems is obvious, right. You strengthen the outer body and it shores up you capability to get the inner body device within those procedures and increasingly that team is positioning itself to become much, much more competitive in sought of the teaching institutions and academic centers because we are shoring up our deformity and conflicts in trauma offerings. That will continue and I would say that over the course of the next 12 to 24 months those programs will continue to produce very important launches that will complete round up the core fusion line. So I think we're in a really good position to start posting consistently positive above market growth numbers and I think it's just going to get stronger in the next 12 to 24 months.
David Roman - Goldman Sachs:
That's helpful. And then maybe just a follow-up on sort of the broader macro. At least the analysis that we've looked at on your core business would suggest that the volume growth that the industry and you have posted over the past couple years is probably below what you would think the normal demographic trends would support. And I understand that there's some hesitancy to call out a broader turn in utilization, but as we look at the data points that have surfaced this quarter, whether it's your numbers, your key competitors, some of the hospitals, etcetera, the environment does look to be getting better. So I was just hoping to get your perspective on what it would take to get you more constructive on a sustainable turn whereby we can start to see volume growth reflect more of the demographic nature of the categories you serve?
David Dvorak:
Yes and I think that you could certain see that in what we articulated happened and we were able to drive within the market on the knee side for instance David within the quarter. I think some of the hesitancy on that is understand from everyone’s prospective just the seasonality shift that may be going on primarily within the United States market, but even though U.S. where there are national healthcare systems that are either dialing up or down procedure rates because of our security measures or disciplines in that regard. You get a little bit of lumpiness. So that said, we've had really consistent and good performance in the OUS markets. So I think that the underlying procedural demand for the solutions is just unmistakable and may be a topic that hasn’t come up in this call, but you can certainly see that in the emerging markets. We continue to perform very, very well in the emerging markets and those penetration rates are low growing classes of folks that are going to be future patients within those markets expanding infrastructure that deliver those solutions and so we're going to be big part of providing those solutions to customers going forward in the important emerging markets. So I think that the dynamics are all positive and I just think it’s a matter of stringing some quarter together from a market growth rate that allows people to become increasingly comfortable that the aging population, the fact that per late stage osteoarthritic patients this is the only solution out there and it works really well and its cost effective for the systems. All of that lines up well for the continued health within these markets that we serve.
David Roman - Goldman Sachs:
Okay. I appreciate all the prospective. Thank you very much.
David Dvorak:
You're welcome
Operator:
Thank you. Our next question comes from the line of Kristen Stewart with Deutsche Bank. Please go ahead.
Kristen Stewart - Deutsche Bank:
Hi, thanks for taking the question. I was wondering if you guys could update us on just -- I guess it's a two part question, the FDA outstanding warning letters, where do we stand with that? And then kind of as a parallel to that, the special items that you guys are reporting. If I look back to the last couple years, it's steadily increased from $75 million to now you're expecting $250 million. How much of those, I guess, special items are really going towards resolving some of the FDA warning letter issues? And maybe just some more clarity on how should we think about that number going forward, since the trend is seemingly increased over the last couple years?
David Dvorak:
So I’ll pick up on the first part of the question, Kristen this is David. The reference to warning letters, pleural, is incorrect. We have a pending warning letter out of the Ponce Puerto Rico facility. We're putting a lot of effort into addressing those concerns. Any of the follow-up inspections that take place that result in Form 43 inspectional observations are the top priority for the company as it relates to our quality and operational excellence efforts. And we have a lot of focus and good work that's been done there. We're communicating that progress to the FDA on a very regular basis and I am quite optimistic that we're on a very positive track towards resolving any of those outstanding issues going forward. I think importantly beyond the reference to the warning letter is just -- this is a core value for the company. It is the top priority to ensure that we have the right quality systems at the foundation of our business and we've made tremendous progress in the last couple of years in particular on that front. And that really is going to be enabler going forward for continued not only quality, but operational excellence improvement. It's going to support the financial returns ultimately, but it has remained every aspect of our business and I think that we have the right level of focus and the right effort underway to not only resolve that, but get the company up with the right kind of foundation for the future.
Jim Crines:
And Kristen this is Jim. With respect to the actual spending as you point out, we coming into the year indicated that we anticipated spending around $250 million on quality and operational excellence initiatives as well as some ongoing spend associated with certain of improved initiatives. Slightly more than half of that spend is connected with the quality and operational excellence efforts across all of our manufacturing sites. So although as David pointed out, the warning letter is connected with a single facility where taking the approach to upgrade our quality systems across all dimensions of our quality system, production and process control, design controls, controls around design transfer across all of our facility. So it’s a very significant effort, a large project. We've got a very capable leader who is a member of our operating community who is overseeing the entire effort and expect that spend will begin to taper off towards the end of 2015. So it will carry over into 2015, but begin to taper off towards the end of 2015.
Kristen Stewart - Deutsche Bank:
By taper off, does that -- I assume it doesn't go away. So we should expect some continued costs, I guess, looking you out for the next couple years? Is that fair or…
Jim Crines:
I think it's fair to say that it will be reduced significantly by the end of 2015 going into 2016.
Kristen Stewart - Deutsche Bank:
Okay. Thanks very much.
Jim Crines:
You're welcome
Operator:
Thank you. Our next question comes from Derrick Sung with Bernstein Research. Please go ahead.
Derrick Sung - Sanford C. Bernstein & Company:
Hi, thanks for taking my questions. I think we're all trying to get kind of a sense of the industry landscape and what that will all look like post consolidation. One of the perspectives that we haven't heard too much from is, what's the hospital customers are thinking and telling you about the impending consolidation. And so I was just wondering if you could maybe share some color on your conversations with the hospitals and the hospital administrators, and what they would say about the impending merger that you're going to be undergoing
David Dvorak:
Yeah I think that the conversations we've had in that regard have been positive at this point. We probably have had more conversations at the surgeon level or I’ve been involved in more conversations at surgeon level and necessarily the administrative level. But here is the thing that the administration and increasingly as time progresses the surgeons care a lot about providing better solutions to the patients but finding a way to do that in an increasingly cost effective way and I'll tell you the message that resonates with the administration side deeply is how can we develop deeper and deeper partnership than we had historically to bring those solutions about an increasingly cost effective way. The broad musculoskeletal portfolio and innovation within system but as well comprehensive solutions and integrated services is of high interest to the administrative leaders within those institutions. And that's an area where I think we're going to be able to put a lot more effort and a lot more resources behind and look to collaboratively construct solution and service offerings that can achieve objectives on both of those fronts. Provide better patient solutions and do that in an increasing cost effective way and it just makes sense when you think about some of the reforms that are taking place, pick a market around the world but here in the United States, the reforms that are being driven by the ACA with the delivery model changes whether it's ACO or bundling give these administrators much more of a reason to become in tuning advance of readmission charges and complications coming back to impact their P&Ls. And I think that this is a good thing. I think it's going to be a good thing for patients because it's going to allow us to come in these more comprehensive partnerships to provide the solutions and to work towards a common goal of getting it right for that patient in short, medium and the long term.
Derrick Sung:
Great. Thanks. That's helpful. And as a follow-up, just wanted to put your views of the global market trajectory in the context of the accretion from the Biomet deal that you're guiding to. So I guess Jim, how sensitive is that accretion guidance that you're providing to whether the global markets end up growing in the low single digits versus the mid single digits? And maybe just any additional color you can provide to us on your global view of the markets would be helpful. Thanks.
David Dvorak:
Sure. We said with the announcement I pointed out earlier our expectation is that combined enterprise will be able to grow in line with market in the short term and again will give sort of more specific color on what we think that is in our fourth quarter call towards the end of January. If this is a market although we would acknowledge that this is a market that has grown and you know as we've said in a range of low to mid single digit. As you will know this is a high margin business. There is certainly opportunity as you're growing at the higher end of that range for the accretion to be at the higher end of the range that we guided to. But I would tell you that within that range, we're very comfortable with $1.15 to $1.25 accretion and adjusted cash earnings per share because at the end of the day it's really a function of the acquired operating earnings as offset by the interest cost on the financing and the dilution associated with the additional shares that are getting issued in connection with the transaction. So as long as Biomet continues to perform the way that they have into the close and the acquired operating earnings are somewhere in line with what we sort of expect them to be as we put that model together and we've no reason to believe at this point that they won't be. I think Derrick, I would tell you we continue to have a high degree of confidence around the guidance that we've provided on accretion.
Derrick Sung - Sanford C. Bernstein & Company:
Okay. Thanks Jim. That's helpful.
Jim Crines:
You bet.
Bob Marshall:
Britney, we have time for one additional question.
Operator:
Thank you, sir. Our next question comes from the line of David Lewis with Morgan Stanley. Please go ahead.
David Lewis - Morgan Stanley:
Good morning. Maybe just two quick questions. First Jim just a question on margins. If you look at this quarter it's been five consecutive quarters of EBIT margin improvement. So I just wonder what's the sustainability of that trend and sort of your ability to complete your cost program as you head into Biomet. And a related to that margin question, I've a follow-up for David as well. The gross margin has not been a source of upside to you, but given the pricing environment, is flat GM is sort of the best we can hope for. So those two questions on margins and then I've a follow-up for David.
Jim Crines:
Sure. We're going to continue to drive hard on the operational excellence initiative side. There is still a lot of work to do I would tell you David and then a lot of opportunity in front of us and if nothing else, those programs, specifically those associated with manufacturing have to offset the impact of any price erosion that we continue to experience on the topline. And we have confidence that they will, but we believe that the opportunity could very well go beyond that to the point where particularly as we see more stability in pricing trends, we could potentially see some expansion of the gross margin. With respect to operating cost, some of what we're doing, some of what we had planned in the way of innovating improvement initiatives to drive towards the $400 million of savings by 2016 as a standalone enterprise we will get -- we will get incorporated into and added on to the synergy targets that the teams are driving across for the combined enterprise. So we have as we pointed out I think at the time of the announcement, I think good visibility to exactly where we will be going into the close and good visibility into where those additional opportunities around what we need to do to drive towards more efficiency in the administrative functions as well as in the operating functions.
David Lewis - Morgan Stanley:
Okay. And then David, just a quick question on FTC, over the last several years the FTC you’ve become increasingly coordinated, but they obviously are independent entities, but you’ve been clear in this first quarter '15 close, no change in timeline, but I think a lot of investors are sort of focused on what we're going to hear this year. So what's the likelihood would we hear something from the FTC before we hear from the EU in the first quarter on any possible remediation. Thank you.
David Dvorak:
Yes, I think they were just -- the process, the way that it has worked from the point of initiation just naturally sets up a circumstance where the U.S. process is ahead of the EU process and so it's more likely that we will progress to the point of clarification in the U.S. than the European side of things as far as the forecast between now and the balance of the year, but obviously we'll keep you posted as we make progress. Again things are cracking very consistently with our original analysis and nothing has changed in the many months that we either were evaluating this area of the deal or executing our plans to seek those clearances. So we're very optimistic that we're going to land where we need to land and in getting the deal closed in the first quarter of 2015.
David Lewis - Morgan Stanley:
Great. Thank you very much.
David Dvorak:
You're welcome. And with that, I would like to thank everyone for joining the call today and for your continued interest and support for Zimmer. We look forward to speaking to you on our fourth quarter conference call, which is scheduled for 8:00 AM on January 29, 2015. I'll turn the call back to you Britney.
Operator:
Thank you, sir. And thank you again for participating in today's conference call. You may now disconnect.
Executives:
Robert J. Marshall - Vice President of Investor Relations and Treasurer David C. Dvorak - Chief Executive Officer, President and Director James T. Crines - Chief Financial Officer and Executive Vice President of Finance
Analysts:
Matthew Taylor - Barclays Capital, Research Division William J. Plovanic - Canaccord Genuity, Research Division Robert A. Hopkins - BofA Merrill Lynch, Research Division Derrick Sung - Sanford C. Bernstein & Co., LLC., Research Division Richard Newitter - Leerink Swann LLC, Research Division Michael N. Weinstein - JP Morgan Chase & Co, Research Division Lawrence Biegelsen - Wells Fargo Securities, LLC, Research Division Jonathan Demchick - Morgan Stanley, Research Division Matthew S. Miksic - Piper Jaffray Companies, Research Division
Operator:
Good morning. I would like to turn the call over to Bob Marshall, Vice President, Investor Relations, and Treasurer. Mr. Marshall, you may begin your call.
Robert J. Marshall:
Thank you, Regina. Good morning, and welcome to Zimmer's Second Quarter 2014 Earnings Conference Call. I'm here with our CEO, David Dvorak; and our CFO, Jim Crines. Before we start, I'd like to remind you that our discussions during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties. Also, the discussions during this call will include certain non-GAAP financial measures. Reconciliations of these measures to the most directly comparable GAAP financial measures are included within the earnings release, which is available on our website at investor.zimmer.com. With that, I'll now turn the call over to David.
David C. Dvorak:
Thank you, Bob. Good morning, everyone, and welcome to our earnings call for the second quarter of 2014. This morning, I'll review our second quarter financial results, providing commentary on the year's progress to date and highlights from our performance. Jim will then provide additional financial details. I'll state all sales in constant currency terms and all earnings results on an adjusted basis. In the second quarter, Zimmer recorded solid sales gains across various categories of our differentiated portfolio of musculoskeletal solutions, most notably in key overseas markets. Consolidated net sales for the quarter were $1.18 billion, an increase of 0.9%. And our earnings per share were $1.49, an increase of 4.2% over the prior year period. In the second quarter, Americas sales declined by 2.7% year-over-year, while Europe, Middle East and Africa increased by 4.9%, and the Asia Pacific region grew 6.9%. I'd like to remind you that these results include the consolidated impact of 1 less billing day in the quarter. We sustained healthy traction overseas, inclusive of strong performances in key emerging markets. In the second half of the year, we'll heighten our focus on improving U.S. performance by leveraging our comprehensive portfolio of clinically proven solutions, as well as our robust pipeline of new and recently commercialized products. Those familiar with Zimmer's value creation framework will know that we're dedicated to consistently creating and returning value for our stockholders. In keeping with that strategy, Zimmer once again delivered against our financial commitments in the second quarter of 2014, while increasing the quarterly dividend and expanding operating margins relative to the prior year period. Our operational excellence programs also continued to drive disciplined expense management as highlighted by the ongoing successes from our strategic sourcing initiatives. And as part of Zimmer's ongoing commitment to quality improvement, we continue to fund enhancements of all aspects of our quality management system. As we've communicated in previous quarters, this focused work will continue as part of our quality and operational excellence agenda. Before discussing our results in greater detail, I'd like to first comment on market and pricing conditions. In the second quarter, underlying global market dynamics were stable and generally consistent with sequential seasonality experienced in previous operating periods. Turning to pricing, Zimmer experienced a price decline of 2.8% in the quarter, which was in line with expectations coming into the year. The sequential movement from the first quarter of 2014 was largely attributable to the anticipated biannual Japanese price adjustment. Turning now to our business units. Knee sales for the second quarter increased 3.5%, reflecting positive volume and mix of 7.3% and negative price of 3.8%. Our Americas segment reported a sales increase of 0.5%, while Europe, Middle East and Africa grew by an impressive 9.4%. And the Asia Pacific region delivered 5.3% growth compared to the prior year period. Our strong results in the Europe, Middle East and Africa region were supported by new market introductions of Persona, the personalized knee system, which continues to gain commercial traction and competitive conversion at a premium price point across the globe. We've also been extremely pleased with the notable overseas performance of our market-leading, clinically proven NexGen knee replacement system. In addition, Zimmer continued to leverage our intelligent instrumentation portfolio in the second quarter, including the iASSIST Personalized Guidance System, Patient Specific Instruments and our digital templating solutions. These advanced offerings are designed to enhance intraoperative precision and efficiency, while delivering ongoing economic and operational benefits to orthopedic service lines. Lastly, our early intervention portfolio continued to achieve sales growth and increase adoption, in line with our expectations. The performance of these products, most notably Gel-One and Subchondroplasty, continue to validate our investments into early stage intervention and joint preservation. Zimmer's hip business grew sales by 0.4% in the second quarter, reflecting positive volume and mix of 3.4% and negative price of 3.0%. These results include a 1.9% sales decrease in the Americas; a sales decrease of 0.8% in Europe, Middle East and Africa; and an impressive 7.8% sales increase in the Asia Pacific region. Our strong performance in the Asia Pacific region was led by the M/L Taper Hip Prosthesis with Kinectiv Technology, the Continuum Acetabular System and BIOLOX delta Ceramic heads. We believe that the ongoing contribution of these and other premium constructs will create additional growth opportunities in future periods in part by leveraging differentiated technologies such as the Avenir hip system, VIVACIT-E advanced bearing material and the Synovasure biomarker test for periprosthetic joint infection. Zimmer's extremities business recorded growth of 5.2% in the second quarter, led by strong performances in the Asia Pacific and Europe, Middle East and Africa regions with 19.4% and 18.0% sales growth, respectively. Despite facing challenging sales comparisons in the United States, as well as competitive product launches which drove some trialing of other systems, extremities continued to benefit from robust sales of our Trabecular Metal Reverse Shoulder System. Together with this leading upper extremity solution, which now includes a Patient Specific Instruments platform, our recent introductions into new anatomical sites are broadening our offerings in this fast-growing category. These exciting products include our Nexel Total Elbow system, featuring VIVACIT-E and the differentiated Trabecular Metal Total Ankle system. Zimmer dental sales decreased by 1.4% in the second quarter. We experienced steady demand across our broad dental implant offerings, including the Trabecular Metal Dental Implant, and solid performances from our leading regenerative product lines. Growth of 4% in the Americas was offset by continued softened demand for premium solutions in Europe, which slowed our overall growth this quarter. However, the ongoing introduction of our P-I-branded, value-based offerings across Southern Europe tempered the impact of this market transition. Trauma sales rose 6.4% in the second quarter, with our Americas segment reporting a sales decrease of 3.6%; Europe, Middle East and Africa growing sales by 14.9%; and the Asia Pacific region delivering 17.9% growth. Our impressive results overseas were driven by strong performances across all major market segments, led by the Zimmer Natural Nail family, NCB Periprosthetic Plating System and the XtraFix External Fixation System. As we look to future quarters, we'll remain focused on the commercialization of strategic portfolio additions, including the existing launch of the Zimmer Distal Radius Plating System, a versatile trauma system with comprehensive instrumentation designed to conform to a broad range of patient anatomy. Zimmer spine sales decreased by 4.4% from the prior year period. This business continues to expand its diversified portfolio, and in the second quarter, bolstered its core fusion offerings with the 510(k) clearances and commercial launches of the Optio-C interior cervical system and the Virage OCT spinal fixation system, both of which have experienced promising early results. Combined with solid performances in key Asia Pacific and European markets, we believe that Zimmer spine is well positioned for growth in the second half of 2014. Turning to our surgical and other category. Zimmer posted a sales decline of 9.9% for the quarter. It's worth noting that after normalizing our results to account for the exceptional performance in the capital sales of our differentiated Transposal fluid waste management system in the prior year, our surgical business continued to post solid results. Sales of both the Transposal system and its higher-margin consumables have remained in line with our execution plan. Our overall results were also bolstered by strong sales of the A.T.S. family of automated tourniquet systems, surgical consumable products and surgical power equipment, highlighted by our Universal Power System surgical instruments. As we look to the rest of the year, we'll continue to leverage this differentiated portfolio for improved growth. Before I close, I'd like to now make some comments about our planned combination with Biomet. As we communicated in April, this transaction will enhance our position in the $45 billion musculoskeletal industry. It will also allow us to offer a broader, more comprehensive portfolio of musculoskeletal solutions across the continuum of care, with both cross-selling opportunities and a revenue mix that is more diversified and predictable. In the weeks following our April announcement, we finalized important financing details of this $13.35 billion acquisition and met a number of key integration planning milestones to finish the quarter on track and on schedule with the process of closing this transaction. Having worked closely with the leadership of Biomet over the course of the second quarter, we've gained invaluable exposure to their highly talented and committed business teams. This experience has heightened our confidence in the value we'll be able to create and deliver as a combined entity. Concerning the ongoing antitrust review of the proposed merger with Biomet, as we announced earlier this month, we received the second request from the U.S. Federal Trade Commission. We're in the process of complying with the request and will continue to work closely with the FTC as it conducts its review of the proposed transaction. With regard to the review in Europe, we've been providing requested information to the European Commission and plan to file the merger notification in the near term. We continue to expect the transaction to be clear and remain confident in our anticipated timeline to complete this combination during the first quarter of 2015. With that, I'll now ask Jim to provide further details on the second quarter and our updated guidance. Jim?
James T. Crines:
Thanks, David. I will review our second quarter performance in more detail and then provide additional information related to our updated 2014 sales and earnings guidance. Our total revenues for the second quarter were $1,183,000,000, a 0.9% constant currency increase compared to the second quarter of 2013. As David noted in his comments, we had approximately 1 less billing day in the quarter on a consolidated basis. Underlying growth rates would be approximately 1% higher on a consolidated basis and nearly 1.5% higher in the Americas. Net currency impact for the quarter increased revenues by 0.2% or $2 million. The positive currency impact for the quarter related principally to our euro-denominated revenues, partially offset by negative currency translation associated with our Japanese yen and Australian dollar base revenues. Our adjusted gross profit margin was 72.6% for the quarter. The margin ratio declined 70 basis points compared to the second quarter of 2013. In the second quarter, we recognized approximately 70 basis points of charges related to the medical device excise tax. Increased pressure from price, coupled with the recognition of negative manufacturing variances associated with our quality and operational excellence programs, were partially offset by ongoing benefits from our cash flow hedging program and reduced year-over-year excess and obsolescence charges. The company's R&D expense decreased 12.6% or $7 million to 4.1% of net sales when compared to the prior year. The decrease in R&D expense continues to reflect focused efforts on our quality and operational excellence initiatives and related dedication of resources. Selling, general and administrative expenses were $456 million in the second quarter, and at 38.5% of sales, were 70 basis points below the prior year. The improved ratio reflects the ongoing benefits from our operational excellence programs, including, among other things, strategic sourcing of indirect supplies and services, as well as the establishment of shared services, leveraged across multiple reporting units. In the quarter, the company reported pretax charges of $64.7 million in special items; $9.6 million in cost of products sold pertaining to global restructuring, quality and operational excellence initiatives and recent acquisitions; and $10 million of interest and financing costs associated with the pending Biomet transaction. Adjusted second quarter 2014 figures in the earnings release exclude the impact of these charges, which include $55.4 million related to quality and operational excellence, initiatives to manufacturing logistics and sales; and $28.9 million in integration and other costs. Additionally, in the quarter, we increased our provision for certain claims related to the Durom Acetabular Component by $21.8 million before taxes. This reflects an increase in the total estimated viability for projected worldwide claims related to Durom, offset by anticipated insurance recoveries. Adjusted operating profit in the quarter amounted to $355.4 million. At 30%, our adjusted operating profit-to-sales ratio was 50 basis points higher than the prior year second quarter. The continued expansion of operating margin reflects our ongoing financial commitment to our stockholders through disciplined execution of our growth and operational excellence, goals and objectives. Net interest expense for the quarter amounted to $12.9 million, which was favorable when compared to the prior year quarter. Adjusted net earnings were $254.7 million for the second quarter, an increase of 4.6% compared to the prior year. Adjusted diluted earnings per share increased 4.2% to $1.49 on a 171 million average outstanding diluted shares. These adjusted earnings per share are inclusive of approximately $0.05 of share-based compensation. At $1.03, reported diluted earnings per share increased 15.7% from the prior year second quarter reported EPS of $0.89. Our adjusted effective tax rate for the quarter was 25.8%, which is 60 basis points favorable when compared to prior year due to higher mix of earnings from lower tax jurisdictions. Our reported effective tax rate for the quarter was 25.5%, as the majority of restructuring and other special items charges are incurred in higher tax jurisdictions. The company had approximately 168.8 million shares of common stock outstanding as of June 30, 2014, an increase over the 167.8 million as of March 31, 2013. Operating cash flow for the quarter amounted to $254.1 million, an increase of 34% from $189.7 million in the second quarter of 2013. The increase is driven primarily by favorable accounts receivable trends in our Europe, Middle East and Africa operating segments and lower tax payments relative to the same period prior year. Net inventories were $1,147,000,000 at the end of the second quarter, an increase of $21.3 million from March 31, 2014. The increase is due primarily to the support of ongoing global commercialization of new product offerings, as well as the effects of going through a direct sales model in certain Eastern European markets. Adjusted inventory days on hand finished the quarter at 304 days, an increase of 20 days as compared to the prior year same quarter. As of the end of the second quarter, net receivables increased to $950 million from $943 million in the second quarter of 2013 or 1% over prior year. Our adjusted traded cash receivable days sales outstanding finished the quarter at 69 days, flat when compared with the prior year. Depreciation and amortization expense for the second quarter amounted to $91.3 million. Free cash flow in the second quarter was $159.5 million, $51 million higher than the second quarter of 2013. We define free cash flow as operating cash flow less cash outlays for instruments and property, plant and equipment. The significant increase in free cash flow was driven by increased operating cash flows, while still supporting the ongoing launch of new products through rolling instrument deployments. Capital expenditures for the quarter totaled $94.6 million, including $62.6 million for instruments and $32 million for property, plant and equipment. I'd like to turn now to our guidance for 2014. In our earnings release this morning, we updated the company's expectation for full year 2014 revenues and now forecast revenues to increase between 2% and 3% constant currency when compared to 2013. We continue to expect foreign currency translation to decrease our reported 2014 revenues by approximately 0.5% for the full year. Therefore, on a reported basis, our revenues are projected to be between 1.5% and 2.5% above 2013 results. For the third quarter, we expect revenues to increase between 2% and 2.5% constant currency and between 2.5% and 3% on a reported basis when compared to the prior year. We expect to recognize gains on hedge contracts in the second half and continue to see positive comparisons related to inventory obsolescence charges and manufacturing variances. Consequently, our guidance for the gross margin ratio for the year remains unchanged and is expected to be between 73% and 74%. Our guidance for R&D, SG&A and interest expense for the full year remains unchanged. However, as you refine your models for the third and fourth quarters, please consider that seasonally higher ratios typically experienced in the third quarter. We expect our SG&A ratio in the third quarter to be in a range of 40.5% to 41%, while R&D expenses as a percentage of sales is likely to be at or near 4.5% for the quarter. Moving down the income statement, the estimated full year tax rate remains at 25.5%. The previously guided fully diluted share count of approximately 172 million shares is now expected to be in a range of 172 million to 173 million shares, due to higher expected employee stock option exercises. Full year 2014 adjusted diluted earnings per share guidance has been updated to be within a range of $6 to $6.10, taking into account our updated expectations for full year revenue growth, as well as a slight increase in the fully diluted share count. As indicated in our earnings release, to arrive at our anticipated reported GAAP earnings per share, you should subtract total charges for special items and certain claims of $250 million and $70 million of Biomet transaction-related expenses on a pretax basis or approximately $1.35 per share. Taking into account the seasonality associated with the third quarter and other factors, third quarter adjusted diluted earnings per share are expected to be in a range of $1.29 to $1.31. Finally, please note that our guidance does not include any impact from any unforeseen events. David, I'll turn the call back over to you.
David C. Dvorak:
Thanks, Jim. In the second quarter, Zimmer achieved solid sales across a number of product categories and geographic regions that are vital to our growth plan. We're also able to return significant value to our stockholders by successfully executing on the ongoing commercialization of new clinically relevant product offerings, realizing the benefits of our operational excellence agenda and demonstrating prudent stewardship for capital. As I mentioned earlier, we're very excited about our planned combination with Biomet. By leveraging the best of both companies, our combined entity will possess an organizational talent advantage that will distinguish us in our industry. Our vision for this combination is to enhance our position as a leading musculoskeletal innovator, identifying new growth opportunities through a number of attractive portfolio additions and shaping future solutions for the evolving healthcare industry. And now I'd like to ask Regina to begin the Q&A portion of our call.
Operator:
[Operator Instructions] Our first question will come from the line of Matt Taylor with Barclays.
Matthew Taylor - Barclays Capital, Research Division:
I just wanted to ask 1 on the deal here. So first of all, can you update us as to whether there's been any change in your views of the net synergies or where they may be coming from with regards to the transaction? And then also, wanted to ask if you could provide any more color on what these subsequent requests have been about and why you're still confident in the timing?
David C. Dvorak:
Yes, on the first part, Matt, there hasn't been a change in the view of our net synergies. We're developing the detailed plans, and we're very confident in what we expressed at the point of the initial announcement of the combination. With respect to the regulatory process as well, the analysis that was the basis for our decision to move forward remains very much in line with what we're experiencing. We see this as being an aspect of the process that is absolutely manageable. We're confident that we're going to get the transaction cleared and look to consummate the combination in the first quarter of 2015. So everything on both fronts is tracking very consistent with the analysis that led to the execution and announcement of the deal in the first instance.
Matthew Taylor - Barclays Capital, Research Division:
And then you called out pricing in your comments certainly in line with the guidance for the year, but towards the higher end. I guess, number one, why did you feel like you needed to explicitly call that out? And are there any other areas of weakness or strength over the next several periods that you would note from a pricing or mix perspective that could change that dynamic?
David C. Dvorak:
Yes, I think that the dynamics have been pretty consistent. As we've said, we're very transparent and provide a fair amount of granularity on the pricing every quarter, Matt. And as we said, the sequential decline from about 2.3% to 2.8% in our case was principally driven by the biannual adjustment that was anticipated in Japan that came in within a range of what was expected. So we're right about at the midpoint of what we guided to back in January. Our expectation was for the full year on price, which was a range of minus 2% to minus 3%. And I think that probably in the short term, commercial execution of new product launches and taking advantage of the mix opportunities are the area for us to focus on to offset some of the price pressure. But again, the price pressure has been pretty consistent.
Operator:
Your next question will come from the line of William Plovanic with Canaccord Genuity.
William J. Plovanic - Canaccord Genuity, Research Division:
Just on the acquisition, one thing I'd like to ask is how were you thinking about the peripheral businesses and the disruptions in those channels? As we look at what's going on in knees and hips, you said you'll keep that distribution in place, but how should we think about the peripheral businesses?
David C. Dvorak:
Yes, we're going to put plans together that are directed and focused on unique aspects of each of those businesses. It's the case as we've had discussions with people that some of the fear around the distribution channel, I think, is more premised upon what one has seen through combinations outside of the large joints side. And so we need to learn from those lessons, both ones that we'd experienced in the past, as well as ones that others have experienced. I think the historic track record on the large joints side is quite good on combining the distribution channels and retaining the momentum of the businesses. So we're going to look at developing these plans unique for each of those business units, and we'll take a bit different approach as necessary and as is consistent with our longer-term vision as to how we want those channels to be structured to make sure that we're growing at or above market in each product category in each of the geographic segments.
William J. Plovanic - Canaccord Genuity, Research Division:
Okay. And then just on the trends in the business in general. We've seen you're the fourth player to report thus far. It seems like Q1 was slow. It was weather and maybe back-end loading due to ACA. As Q2 rolls out, it looks like it's not coming back to the length that we had thought it would. Do you think there's a different type of seasonality in the market today? Do you think the market maybe is slowing a bit? How should we think about this?
David C. Dvorak:
Yes, I don't think that the market is slowing. I think that the market is in a range of something that should properly be characterized as stable, certainly across the global markets, that's the case. Within the United States, which has obviously been the area of a lot of focus coming out of the fourth quarter 2013 with the uptick that we saw, I do think that you're going to see some shift in seasonality. We clearly saw that as far as a percentage of revenues for the total year that were generated in Q4. That was a bit of an outlier. And I do think that you're going to see some of that shift be retained in 2014. It's a bit of a question as to how much or whether or not that trend will even continue further, but it was something that we saw in the fourth quarter. As you look at the sequential patterns from Q1 to Q2 in 2014, they're actually pretty consistent with historic trends. So again, on a global basis, this is a stable market. And I think that as we get into the second half, we'll all gain insight as to how much of that seasonality shift is permanent, whether or not that's going to continue as an expanded trend.
Operator:
Your next question will come from the line of Bob Hopkins with Bank of America Merrill Lynch.
Robert A. Hopkins - BofA Merrill Lynch, Research Division:
So first question is really on the performance in the quarter and then a little bit on the guidance. So I'd love to ask you to comment on a couple things. One, just broadly, why are you lowering the revenue guidance? What's going on in the business that was different than you thought 30 days ago? And also, Jim, if you could comment on why gross margins were weak this quarter relative -- especially relative to Q1. I'm just trying to understand that a little bit better. And then, finally, to get it all in, in one thing, on the selling day issue, not to nitpick, but last quarter, you said you had an extra half day, now it's an extra full day. I just wanted to kind of reconcile that.
David C. Dvorak:
Yes. On the last of those, I think we said we had an extra half day in the first quarter. What we said in Q2, Bob, was that we had 1 less billing day, okay. So with respect to the guidance, a lot of that is just math relative to where we've been for the first half of the year. We came in with the midpoint of 4%. We're now revising to 2.5%. A lot of that is just the reality of the U.S. performance in Q2 and the consolidated results in Q2 and what it would take to do performance-wise in the second half of the year to push up towards that midpoint of 4%. So we're guiding at 2% to 3%. And if one does the math, there's obviously some sequential improvement in growth rates that is embedded in the potential for that guidance for the second half of the year. But it's another quarter of insight. Some of that is market, but I think we've got some work to do, frankly, in the United States to fully exploit the opportunities that we have with the new product introductions. In the second quarter, we did a better job of exploiting those opportunities outside the United States as is evidenced by, for instance, the strong performance in knees within the Europe, Middle East and Africa geographic segments and the strong performance in hips within the Asia Pacific region. So the portfolio is there, and we're going to redouble our efforts to focus on taking advantage of what the market gives us in the United States in the second half of the year and hope that we generate some positive trends in our performance sequentially into Q3 and Q4. You want to grab the margin question?
James T. Crines:
Sure. Bob, this is Jim. Just on the gross margin question, we guided coming into the year a gross margin ratio at 73% to 74%. We're still guiding to that same range. So we had good visibility coming into the year as to what the opportunity would be on gross margin and, frankly, still have good visibility to how we're going to achieve that. In the second half, as I indicated, the lower anticipated manufacturing variance is really the principal difference in getting from kind of where we are in the second quarter to where we expect to be in the second half of the year. There's also some differences, some favorability and hedge gains second half relative to the first half. But I would tell you, the more significant contributor to the difference in gross margin ratios between both the first and second quarters, as well as the step-up from second quarter into the second half, have to do with manufacturing variances. And those are largely connected with the operational and quality excellence initiatives that we have underway. Those variances -- negative variances were largely incurred in the second half of last year, that's why we had good visibility as to how they were going to impact on this year. Those are largely amortized off now through the first half of the year. And we have visibility now to the actual variances that were incurred in the first half that will impact on the second half and why we feel confident in the step-up we're anticipating in the second half of the year relative to the second quarter.
Robert A. Hopkins - BofA Merrill Lynch, Research Division:
And then on the Americas business, is that a little early Biomet disruption, you think? Or is there something else going on?
David C. Dvorak:
I don't at all believe that. If you look at the announcement date, we announced the transaction and our entering the agreement for the transaction on the 24th of April. And so you essentially had 2 months. And we're just not seeing signs of that, Bob. I think that this is for us to improve our performance relative to the opportunity we have with the product bag and the new product introductions. And so, as I said, big area of focus for us in the second half of the year.
Operator:
Your next question will come from the line of Derrick Sung with Sanford Bernstein.
Derrick Sung - Sanford C. Bernstein & Co., LLC., Research Division:
Question. Just a follow-up on the performance in Americas. Is the launch of the Persona knee -- I know there were higher expectations for that or relatively high expectations for that going to the year, and that was going to be a big growth driver. Is that one of the areas that you're looking to improve upon or maybe the one area that isn't quite meeting your expectations versus what you thought about going into the year? And then last -- on the call last quarter, you talked about your expectations that the combined Zimmer-Biomet organization would be able to grow sort of revenues at market post integration, including kind of any sort of revenue dis-synergies. Is that still your view, given kind of your new outlook on your business? Or has that changed also?
David C. Dvorak:
Sure, Derrick. The launch of Persona continues to be a success story for us. We've got some other categories in some of the legacy knee business that we need to improve our performance upon, but we're tracking in a consistent manner with expectations on the capability to take that system into competitive accounts and not only get trialing but convert business. So the promise of Persona is unchanged relative to the prior conversations and discussions we've had. And as far as the go-forward view as to -- on a combined basis, we absolutely believe that we're going to be able to, in the initial stages, grow the combined business at market. And obviously, as we complete the integration post-closing in the quarters, an operating period or 2 thereafter, we would expect to accelerate above market growth rates within the musculoskeletal industry.
Derrick Sung - Sanford C. Bernstein & Co., LLC., Research Division:
Okay. And on the deal, now that you've had a chance to look more deeply kind of into the financial aspects of it, et cetera, are there any tax opportunities that maybe you didn't call out on -- when you announced the deal that might be available? I'm thinking in terms of perhaps intercompany loans or any sort of rationalization or optimization of the manufacturing footprint that might leave any tax opportunities in the integrated business?
James T. Crines:
Derrick, this is Jim. I think it's fair to assume that we have teams that are very focused and working with outside subject matter experts kind of helping us identify where those opportunities are to either drive a lower effective tax rate for the combined entity going forward and/or just as importantly, determine how we might be able to get access to the cash that's going to be accumulating offshore connected with the businesses overseas and the revenues and profits that are being generated overseas. And so there's a real focus on it, a dedicated effort. Smart people with a lot of expertise that are going to continue to work the issues and determine how we can optimize both the effective tax rate, as well as our -- the opportunity to access the cash flow that's going to be -- or the cash that's going to be accumulating offshore. But beyond that, I'm not -- we're not at a stage where we could provide any more specific guidance.
Derrick Sung - Sanford C. Bernstein & Co., LLC., Research Division:
Okay. And if I could just slip one quick one in. Could you give us a sense for the contribution of Gel-One this quarter in the early intervention portfolio? You mentioned it was kind of tracking few expectations. I think a couple quarters ago, we were kind of in that $5 million to $10 million range. And maybe give us a sense for where we are with that launch.
James T. Crines:
Yes, we continue to pick up share with that product really, frankly, very pleased with the progress that we're making. There's more opportunity in front of us, and that team is focused on taking full advantage of those opportunities to get that product listed on formularies where it's not currently listed on formularies, just as 1 example. I don't want to and we don't want to get into providing brand sales information on these calls. We have hundreds of brands, Derrick. So I know as much as you're interested in for the tracking how that particular one is doing, I'm not going to provide any more specific information than that.
Operator:
Your next question will come from the line of Richard Newitter with Leerink Capital.
Richard Newitter - Leerink Swann LLC, Research Division:
I was just hoping just going back to the lowered top line guidance, David, if you could maybe talk a little bit about how much -- I appreciate maybe you're revising it to see what happened, play out in the second quarter. But how much of the step-down can you attribute specifically to kind of a change in your view of the pricing kind of environment and what you saw in 2Q in the first half versus kind of volumes? Can you maybe parse that out a little bit?
David C. Dvorak:
Yes, I wouldn't say that any significant portion of it is based upon a revised view of pricing. Again, if you go back to the January call, we provided some specific visibility to what we're anticipating for the year, and that was a range of negative 2% to negative 3%. We're bang on in the middle of that halfway through the year. So that really doesn't impact our go-forward view. So you pull that out to volume and mix, and both of those are highly related to our commercial execution. And coming out of Q2 here that we're going to focus on, obviously, for improvement in the United States commercial execution.
Richard Newitter - Leerink Swann LLC, Research Division:
Okay. And then just kind of adding onto an earlier question that was asked. With respect to kind of the longer-term outlook post the Biomet deal, assuming it goes through on time, as you think it will, the question I have is does the -- perhaps a slightly lowered growth rate for some of your core recon businesses heading into that transaction impact what you think the kind of top line dis-synergy impact could be and how that impacts the potential for the cost synergies to offset that and lead to your net synergy number? Or is all of that fully intact and you feel confident that you can regain through execution whatever, perhaps, you didn't do as well as you wanted to do in 2Q?
David C. Dvorak:
Yes, we're confident. We're confident. We've got all the necessary ingredients, talent in the field, the right product offerings, a whole variety of terrific new products and innovative solutions that either are launched or are in the process of being launched. So we're going to be in good shape as we consummate the combination and move forward. And I think that the other side, on the Biomet side, they're doing good work and continuing their strong momentum. So our goal is, obviously, independent of one another, to maintain the momentum so that we hit that start line and -- with good boat's feet. And I think that I'm very confident at this point that we're going to be able to achieve that objective and then take it forward from there.
Richard Newitter - Leerink Swann LLC, Research Division:
And just one last one, on the competitive trialing that you called out in the shoulder arena, can you just describe kind of what you're hearing? And is this -- are they generally coming back to you? Or what's the feedback then? Do you feel confident that that's transient?
David C. Dvorak:
Well, I think that there are just a lot of new systems and the number of players within that space has broadened in a pretty significant way over the course of the last operating period or 2. So we've enjoyed a nice position historically within that market. And we have some important new innovations, including the PSI offering for upper extremities. We continue to drive nice gains and growth with our Trabecular Metal Reverse Shoulder. And suffice it to say that we have some other things in the pipeline that are going to help us ensure that the trialing doesn't become a permanent conversion in the go-forward quarters, okay.
Operator:
Your next question will come from the line of Mike Weinstein with JPMorgan.
Michael N. Weinstein - JP Morgan Chase & Co, Research Division:
I wanted to follow up a couple of items. First, I want to follow up Bob's question just on the gross margins. Jim, you talked about the benefit of your hedging program. It showed up a little bit this quarter. It sounds like it'll be there in the back half of the year. Could you quantify what impact that will have in the back half of the year? And then as those hedges roll over, does that become a headwind for 2015? How should we think about that?
James T. Crines:
I guess if you look at the year-to-year comparisons, Mike, it's a modest improvement year-to-year. But in absolute terms, it's probably somewhere in the range of 40 -- short of 40 basis points in terms of contribution in each of those quarters, in Q3 and Q4. And yes, going into next year, and we know, with the hedging program, what it does is provides protection for an operating period or sometimes a little more than an operating period. And we have that much time to get whatever sort of things we need to get in place, whether it's adjustments in pricing or reductions in standard costs to offset whatever decline we might otherwise see in gross margins as a consequence of currency changes. So it's only a headwind to the extent that we don't offset it with cost savings and/or price changes. And then as I pointed out to Bob, you understand as well, I think everybody understands, the headwind associated with the medical device tax in this year's numbers, which will not have, obviously, going into next year because it'll be fully -- obviously, fully reflected in the margin as we get through the end of this year.
Michael N. Weinstein - JP Morgan Chase & Co, Research Division:
Let me shift gears, and I know you mentioned some of this earlier, but I just want to understand the strategy around distribution, particularly in U.S., the 2 U.S. recon sales force. So it sounds like, David, the plan for now is to try and keep everybody in place for some period of time post-closing. Can you just help us understand, one, the cost of a program like that? I know we've seen it in other companies. So how much will you invest in order to retain distribution for some period of time? And then two, how long do you think that period of time is? Is there a point which, is it year 2 in which we would expect to see greater integration of the U.S. distribution system?
David C. Dvorak:
Yes, I think I would tell you that from a starting point, we've made the statements and commitments to retain all of the sales positions for both entities. And that's really important because from our perspective, we're going to have a broader set of solutions and offerings in order to fully leverage the cross-selling opportunities that come with this combination. We're going to need all of that sales talent, and there's a pretty extraordinary level of sales talent in both sides of these organizations. So the design of that distribution channel, all of that work is in process at this point in time, with the leadership teams having been established. And in the coming weeks, months, they're going to continue to make good progress on that front, but it's premised upon retaining the sales positions and fully leveraging all of the products and solutions the combined entity will possess. So that is the fundamental value creator from the company's perspective on a combined basis. It's also the primary value creator from the customers' standpoint, and will align the sales folks' opportunity to do really well economically in accordance with achieving the objective and realizing the full potential.
Michael N. Weinstein - JP Morgan Chase & Co, Research Division:
So I'm sorry, but coming back to the question, do you know what the cost will be of retention? So you're going to put a retention program in place. Do you have at this point an estimate what that cost would be? Is that something that is in the P&L? Or is that something that is outside the P&L, Jim?
James T. Crines:
Yes, Mike, this is Jim. As we indicated when we made the announcement, we anticipate spending somewhere in the range -- somewhere in the order of $400 million on costs to integrate. So that would -- within it, would be an estimate of what we expect to spend on both retention and integration. And it would be separated out, if you will, excluded to arrive at our cash earnings measure.
Operator:
Your next question will come from the line of Larry Biegelsen with Wells Fargo.
Lawrence Biegelsen - Wells Fargo Securities, LLC, Research Division:
I just wanted to come back to the assumption for the Biomet deal. So how should we think about the accretion from the Biomet deal in the first year? Is it still the $1.15 to $1.25? And how should we think about the base EPS that's offered for 2015? The midpoint of your EPS guidance for this year is about 5%. So how should we think about kind of the underlying EPS growth for '15? And then I have a follow-up.
James T. Crines:
No change in the expectations with respect to year 1 accretion, so still in a range of $1.15 to $1.25. As you pointed out, midpoint of our guidance for 2014 EPS on an adjusted basis is $6.05. And we haven't, at this stage, obviously, given guidance for 2015 EPS for Zimmer on a standalone basis. So you'll have to make whatever assumptions you feel sort of appropriate with respect to what kind of growth. We're going to continue to run the business, and we would certainly continue to run the business the way we have been over the past number of years, driving leverage, earnings growth off of the top line opportunity that still view to be somewhere in the range of low to mid-single digits. So that hopefully provides you with at least a little bit of direction on how to think about the expectation that we have for the combined entity for 2015.
Lawrence Biegelsen - Wells Fargo Securities, LLC, Research Division:
That's very helpful. And I just wanted to come back to pricing. If we take a step back and we look at the pricing trends for you and your competitors in hips and knees over the past few years, it looks like there has been a degradation in pricing from about 2% in 2011, 2.5% in 2012 and '13, and about 3% or so this -- thus far in '14. Is that a fair assessment of the pricing environment? And can you -- Jim, in the past, you've talked about kind of pricing pressure going forward and this kind of reversion to the mean, if you will. Where are we in that process? And what can you tell us to give us confidence that we won't see further degradation, let's say, over the next year or so?
James T. Crines:
Sure. Well, as we've talked about over the past couple of operating periods, we continue to experience some pressure, particularly at the high end of our price curves. And particularly in the U.S. market, which has traditionally, just in terms of healthcare service providers, has been a somewhat fragmented market. It's becoming a lot less fragmented, obviously, with hospitals consolidating, large integrated networks coming together and doing their purchasing across those entire networks. That will continue, but we have been able to provide very clear guidance on what our expectations are. That guidance really hasn't changed. It's been typically in that range of around minus 2%, minus 3%. We do know, with respect to the consolidated sort of outlook and we'll again provide some guidance when we get to that point with respect to 2015. But at least in 2015, we will again anniversary out of the Japan biennial price cuts. So that'll provide at least a bit of a tailwind as we get into the back half of 2015. It's hard to say sort of exactly when we would expect to see those pricing trends, particularly within the U.S. market, begin to stabilize. But the strategies that we're developing and the tactics that'll be deployed within the U.S. market will certainly be directed at bringing more stability, if you will, particularly as we provide concessions to account at the higher end of the curve.
Operator:
Your next question will come from the line of David Lewis with Morgan Stanley.
Jonathan Demchick - Morgan Stanley, Research Division:
This is actually Jon Demchick for David. I know it's been covered a bit on the call, but I wanted to try and jive some of the comments about seasonality and then also sales guidance. I mean, it sounded like you guys weren't expecting a change in the seasonal trends, which push sales higher in the back half. But it looks as though when you adjust for the day, growth is expected to be organically stable in the back half relative to the first half. Are there any specific headwinds that you expect in the second half offsetting the increased seasonality that we typically expect? I mean, it sounded like pricing wasn't necessarily the culprit here.
David C. Dvorak:
No, there aren't. I think that the toughest thing to predict is off of last year's uptick, how much of that seasonality shift that we saw last year will become baked into 2014 and future periods and as a consequence, a permanent seasonality shift as opposed to more of a onetime acceleration in Q4 from 2013.
Jonathan Demchick - Morgan Stanley, Research Division:
Very helpful. On the Biomet transaction, just had a couple quick questions. Was there any timing of expectations on complying with the second request? And then also, what was going into the $70 million of additional expenses related to Biomet? I mean, is that just financing? Or is there anything else there?
David C. Dvorak:
Yes, everything that we've had by way of experience on the regulatory submission process and ultimately path towards clearance is very consistent with the due diligence that we conducted leading up to the announcement of the transaction. So nothing at all out of line with expectations, and the work streams are moving forward and the teams on both sides are being very responsive to the request. So we, again, would just express confidence that the transaction will be cleared and that from a timing standpoint, the expectation continues to be the first quarter of 2015.
James T. Crines:
Yes, and just with respect to the $70 million, the majority of that is related to the financing, which covers, at this stage, both the bridge financing, as well as the bank syndication, which is done in the credit facility. As well, there's some significant fees associated with the integration planning process, which is underway, legal fees associated with the application process here in the U.S. and in Europe, as well as some financial advisory fees associated with the process we'll go through to begin to value the entity that we're acquiring. So that covers what's included in the $70 million.
Operator:
Our final question will come from the line of Matt Miksic with Piper Jaffray.
Matthew S. Miksic - Piper Jaffray Companies, Research Division:
So one on just the tone and the growth that you saw in the quarter, maybe for David. Appreciate the color on the stability of the market. You mentioned you have -- I thought you said you had some work to do in the U.S. to kind of exploit the Persona launch maybe more effectively. If the market's improving sequentially here in Q2, what is it you think that created the challenge in the U.S.? And what kind of things can you do to sort of reinvigorate the growth behind that launch here in the second half? And then I have a follow-up.
David C. Dvorak:
Yes, I think that what I was expressing is that the Persona launch continues on track, Matt, and consistent with our expectations. I, in response to one of the prior questions, was referencing the fact that the legacy business needs to be strengthened and our support for that business. So some of that is probably, naturally, a high level of focus and energy on the Persona launch executing well on that front and needing to ensure that at the same time, we're taking advantage of the opportunities that we have in other product categories, as well as providing a high level of attention and focus on the legacy business, including the NexGen business, importantly within the knee category. So it's blocking and tackling on the commercial execution side that is going to lead to the improvement that we look to drive in the second half of the fiscal year. And I don't think that there's anything related to the deal announcement of significance, and I don't think that there's any big unknown in relation to that. So I think we know what we need to do.
Matthew S. Miksic - Piper Jaffray Companies, Research Division:
So we look at these big knee system launches like Persona, it's like a 3-year, maybe a 4-year product cycle to fully kind of roll it out and execute it, and this is year 2. And just from what you're saying, it sounds like there's nothing in particular that's different about what you needed to do this year than last year. Is that fair? Is this just continued execution?
David C. Dvorak:
Yes, I think that, that's right. And I think that if you look at our performance sequentially last year, it improved as the year progressed. I think that in the rhythm of the operating period, there's a little bit of a bolus of activity on the front end of the year to get the compensation plans and instrument set deployments launched that are part of the operating plan year. We've done that. We would expect to get those turns up and to start retrieve some of the benefits from those first quarter and second quarter activities and hopefully get on a track that looks a lot like the sequential improvement that we saw in the second half of 2013 within the United States. I mean, there's no doubt that we continue to track fine relative to the market, above market performance on a global basis in the knee category and likely a bit above market performance in the United States as well.
Matthew S. Miksic - Piper Jaffray Companies, Research Division:
And then the follow-up on the deal, the Biomet deal. I just wanted to push you a little bit on, I know that you are confident in the messaging that you're sending down to distribution. But I guess I know that this did not factor into your comments on guidance, the change in guidance. But should we not expect some distraction? Should we not expect some -- given that these are, in many cases, third-party distribution, so help me understand a little bit about how we should be thinking about the pace of the business or -- heading into that acquisition.
David C. Dvorak:
Yes, I think there are always going to be dynamics that relate to the alignment in management across the different aspects of the business, Matt. And whether it's a distraction because of a big launch in a large joint category on one side or the other, or some other dynamic taking place, whether it's an internal organizational matter or something more significant like this combination. But look, winners are going to react as winners do. They're going to step up and perform in those circumstances, and we're going to see that prevail. We're going to see people that believe in the promise of this combination and the capability not only to cross-sell upon the day of closing, but the broader promise of being able to innovate in a truly differentiated way because of what this combination brings and want to be part of that. And I am absolutely confident that at the rep level and the territory leader level, we're going to put together a team of talent that is going to be unmatched in the industry. And whether or not there's some bump and grind along the way to getting there, one would expect that there would be some of that, but that's our responsibility to manage it. And again, the closer I get to the talent, I know our group and learn more about the Biomet group, I'm absolutely convinced that the capability resides within that channel. And we're going to act in a manner that's consistent with the articulation of the promise of this combination and the manner to bring that out. So we're very confident, Matt, that we're going to land in a good place. So with that, I'd like to thank everyone for joining the call today and for your continued interest and support. We look forward to speaking with you again on our third quarter conference call, which is scheduled for 8 a.m. on October 23. I'll turn the call back to you, Regina.
Operator:
Thank you, again, for participating in today's conference call. You may now disconnect.
Executives:
Bob Marshall - VP, IR & Treasurer David Dvorak - CEO Jim Crines - CFO
Analysts:
Bob Hopkins - Bank of America Merrill Lynch Mike Weinstein - JP Morgan Matthew Taylor - Barclays Capital David Roman - Goldman Sachs David Lewis - Morgan Stanley Matt Miksic - Piper Jaffray Derrick Sung - Sanford Bernstein Joanne Wuensch - BMO Capital Markets
Operator:
Good morning. I would like to turn the call over to Bob Marshall, Vice President, Investor Relations and Treasurer. Mr. Marshall, you may begin your call.
Bob Marshall:
Thanks, Toni. Good morning. I'm here with the CEO, David Dvorak; and our CFO, Jim Crines who discussing this morning’s announcement regarding the combination of Zimmer Biomet. We will also briefly cover Zimmer’s First Quarter 2014 financial results announced separately this morning. We will be using a presentation this morning which is available on our website for download and is also currently available on the SEC's website as exhibit 99.2 to the Form 8-K we filed this morning. Before we start, I'd like to remind you that our discussions during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties. Also, the discussions during this call will include certain non-GAAP financial measures. Reconciliations with these measures to the most directly comparable GAAP financial measures are included within the earnings release, which is available on our website at investor.zimmer.com. With that, I'll now turn the call over to Jim who will provide an overview of our quarter results and guidance before passing call to David to discuss the Biomet transaction. Jim?
Jim Crines:
Thank you Bob. I know you’re all anxious to hear more about the announcement, we issued this morning regarding our definitive agreement with Biomet. I will therefore keep my comments in our first quarter performance brief. Our total revenues for the first quarter were $1.161 billion a 3.2% constant currency increase compared to the first quarter of 2013. Net currency impact for the quarter decreased revenues by 1.2% or $14 million, our adjusted gross profit margin was 74.4% for the quarter, a more favorable mix of products and geographic revenues together with foreign currency hedge gains, cost savings from our operational excellence initiatives and reduced excess and obsolescence charges effectively offset the impact of negative price and increased head wind for the medical device tax in the quarter. The company’s R&D expense decreased 11.1% or $6 million on a reported basis to 4.1% of net sales when compared to the prior year. Selling, general and administrative expenses were $464 million in the first quarter and at 40% of sales were 50 basis points below the prior year. We continue to make significant progress in realizing savings from our operational excellence programs while continuing to invest in selling, distribution and marketing cost in support of the commercialization of a number of new products. In the quarter the company recorded pretax charges of 45.9 million in special items and 7.7 million in cost of product sold pertaining to global restructuring, quality and operational excellence initiatives and recent acquisitions. Adjusted first quarter 2014 figures in the earnings release exclude the impact of these charges. Adjusted operating profit in the quarter amounted to $352 million at 30.3%; our adjusted operating profit to sale ratio was 100 basis points higher than the prior year first quarter. A significant improvement in our adjusted operating margin in the quarter reflects to the progress we have made in restoring growth to certain geographic markets and higher margin product categories within our musculoskeletal portfolio. Net interest expense for the quarter amounted to $12.5 million which was favorable when compared to the prior year quarter. Adjusted net earnings were $258.1 million for the first quarter an increase of 7.2% compared to the prior year, adjusted diluted earnings per share increased 6.4% to a $1.50 on a 171.8 million average outstanding diluted shares. At a $1.29 reported diluted earnings per share increased 0.8% from the prior year first quarter reported EPS of a $1.28. Our adjusted effective tax rate for the quarter was 24.1% and was 70 basis points favorable when compared to prior year due to the recognition of a tax benefit relating to an international reorganization of certain of our subsidiaries. I would like to turn now to guidance for Zimmer as a standalone enterprise for 2014 which in many respects is unchanged from prior guidance but in one fact it has impacted [technical difficulty] change first discussing revenues in other operating measures. In earnings release this morning we reiterated that the company expects full year of 2014 revenues to increase between 3% and 5% constant currency when compared to 2013. We continue to expect foreign translation to decrease our reported 2014 revenues by approximately 0.5% for the full year. Therefore on a reported basis our revenues are projected to be between 2.5% and 4.5% above 2013 results. For the second quarter reflecting seasonality consistent with the prior year as well as the loss of a billing day we expect revenues to increase between 2% and 3% both on a constant currency and on a reported basis when compared to the prior year. As a result of the pending transaction announced this morning we have suspended our share repurchase program in order to preserve capital for funding of the acquisition. Consequently we now expect the fully diluted share count to be approximately a 171.5 million shares in the second quarter and approximately a 172 million for the full year. This compares with our prior guidance for diluted weighted average shares outstanding for 2014 of approximately 169 million shares. The higher share count has the effect of lowering our expectation for full year adjusted diluted earnings per share by approximately $0.10. The company now expects fully year 2014 adjusted diluted earnings per share to be within a range of $6 to $6.20. Prior full year guidance had been in the range of $6.10 to $6.30. As previously indicated to arrive at our anticipated reported GAAP earnings per share and you should subtract total charges for special items of $250 million pretax or approximately $1.10 per share. Taking into account our lower anticipated hedge gains in the near term as well as the higher share count second quarter adjusted diluted earnings per share are expected to be in the range of $1.46 to $1.49. Finally our guidance does not include the anticipated cost associated with the impacts from the jointly announced pending transaction with Biomet or other unforeseen events. David I will now turn the call back over to you.
David Dvorak:
Thanks Jim. Good morning everyone and thanks for joining us this morning. I’m excited to talk with you about the announcement we issued this morning regarding our definitive agreement with Biomet. This milestone combination creates a leading innovator in the musculoskeletal industry that we believe will deliver significant benefits to patients, providers and all of our healthcare stakeholders. Together we will be better positioned to shape solutions for the evolving healthcare industry. Let me start with an overview of the terms of the transaction which is on slide 5 of the document that Bob referred to. Under the merger agreement Zimmer will acquire Biomet for a combination of $10.35 billion in cash and aggregate number of shares of Zimmer common stock valued at $3 billion. Upon completion Biomet shareholders will own approximately 16% of the combined company and will have two representatives on the Board which will be expanded accordingly. The transaction is not contingent upon financing which is fully committed. Finally the transaction is expected to close in the first quarter of 2015 subject to customary approvals. Turning to slide 7, Biomet’s financial and operational profile will bring significant value to Zimmer and is highly consistent with the value creation framework that we used to guide our strategy. Many of you on this call have probably heard us discuss our value creation framework and you can see that this combination is consistent with the guiding principles illustration by the three pillars of our strategy, growth, operational excellence and prudent capital allocation. This combination is certainly about growth, together the combined company will be more competitive in our knee and hip franchises with a more diverse revenue base to increase scale and faster growing markets in adjacent categories. We will also gain meaningful entry into sports medicine and we will have a research and development teams that will power and enhance innovation. Operationally these complimentary businesses are ideal partners; together we will accelerator our opportunity to transform the business model to meet the needs to meet the needs of the evolving healthcare industry. At the same time we expect to achieve approximately $270 million synergies by 2017 with approximately $135 million anticipated in the first year. Additionally we expect to source the funding necessary to grow and deliver anticipated double digit accretion to adjusted earnings per share to our stockholders. This transaction is also consistent our disciplined approach to mergers and acquisitions. In the near to medium term we will focus free cash flow on debt repayment and dividends and then suspend share repurchases as Jim mentioned. We expect a strong cash flow to enhance the combined company’s future financial flexibility and to allow us to continue to support necessary capital investments as well as maintain a stable dividend of 15% to 20% net income following the closing of the transaction. Jim will discuss our anticipated capital structure profile in more detail, however with Biomet we will generate increased cash flows through working capital efficiencies that come with scale which positions us well to pay down the debt overtime so that we can maintain and improve our investment grade credit ratings. This next series of slides beginning of slide 8 take a deeper dive into how we expect to be able to shape our musculoskeletal solutions are developed and delivered. Our success will be in our ability to leverage the combined experience and capabilities of both companies. To offer more personalized solutions that benefit patients across the continuum of care. Our combined company will be supported by a research and development spend capability of approximately $360 million and will immediately benefit from a combined portfolio of innovative solutions as well as efficiencies gained from combining each companies respective R&D effort. Over the longer term our combined R&D spend will allow us to more rapidly bring to market a broad portfolio of musculoskeletal products, technologies and services. And do so more efficiently than ever before. This includes game changing solutions in category such as early intervention and joint preservation, personalized devices, intelligent instrumentation as well as value based offerings for emerging markets. In short this combination allows for the development of clinically relevant solutions for our patients while equally important creating efficiencies for providers and payers. Overall we’re bringing together the best of the best to create new solutions that address stakeholder challenges in the evolving healthcare environment. Moving to slide 9, our combined portfolio in innovation capabilities underscore how Zimmer and Biomet will create a leader in the $45 billion musculoskeletal industry. We will have enhanced diversification and strong scalable platforms in faster growing sports medicine, extremities and trauma product categories. This together with enhanced scale and other categories will benefit the full spectrum of our key constituents and address current market demands while also growing the market in other category such as knees, hips, surgical spine and dental. Slide 10 underscores the strengths and advantages of our combined workforce. We’re excited that this combination will allow us to bring together the best talent in the industry committed to medical training and education. Both companies have strong sales force teams to achieve cross selling opportunities as early as day one. We believe it will be better positioned to deliver business model innovations that benefit providers and patients. With the right mix of solutions together we can provide cost effective ways to reduce complications and readmissions and it will benefit the overall market and result in an increased patient satisfaction. We’re further dedicated to maintaining a long term commitment to our combined skilled labor force. Our expertise in manufacturing will remain critical to our ongoing success and bring life to the innovations we develop. Of course we expect all of these benefits to enhance value for our stockholders. As we outline on slide 11, the combined company will have solid fundamentals through a more diversified and predictable revenue mix and generate significant cash flow. We expect double digit accretion to adjusted earnings in the first year following closing. In addition return on invested capital from the transaction is expected to exceed cost of capital by the end of year three with enterprise return on invested capital expected to exceed the weighted average cost of capital in year one. With that I will turn it over to Jim who will take you through more a detailed on the pro forma financial profile combined portfolio as well as our integration plans.
Jim Crines:
Thanks David. Slide 13, shows a pro forma business mix by category for the combined company. A pro forma combined revenue footprint on a full year 2013 basis was $7.8 billion with $4.62 billion Company from Zimmer and 3.14 billion from Biomet. Through this combination we will enhance the scale and competitiveness of all of our product franchises with each product category measuring no less than 500 million in size in three of our franchises with over 1 billion plus [ph] of revenue. Knees will be the company’s largest category accounting for 37% of the combined businesses pro forma revenue or 2.8 billion on a 2013 basis. The combination of Zimmer and Biomet will create a broad portfolio of solutions and the latest advances in the knee arthroplasty by combining best in class implants and intelligent instrumentation. Our combined hip business will be the company’s second largest category on a revenue basis making up 26% of the overall business or 2 billion in revenue. This transaction gives us a platform for industry leading innovation and new growth in this area as well as a more complete portfolio to address the continuum of care. The third largest category of the combined company will be sports medicine, extremities and trauma which together will comprise 15% of the overall business and 1.2 billion of 2013 combined revenue. By combining Biomet’s emerging sports medicine business with Zimmer’s highly differentiated early intervention devices we will be better able to offer competitive and attractive solution to customers. We will also benefit from strengthening our presence in emerging markets and an extended portfolio that covers upper and lower joints which will position us to grow our extremities and trauma business going forward. In the surgical, biologics and other category this combination allows for increased cross selling of surgical and other devices through combined global reconstructing sales channels and together with Biomet we expect to establish critical mass in both spine and dental that will position the company to compete effectively and gain share in these important markets. As you can see from slide 14, this combination creates an even compelling opportunity for our stakeholders as the second largest player in the global musculoskeletal industry with the 17% share of overall revenues. We believe this will enhance our competitiveness while leaving room for new growth in this $45 billion industry. Slide 16 provides an overview of the operating earning synergies, we expect to realize from this combination. We expect to achieve approximately 270 million of net annual synergies by the third year of post-closing which represents approximately 8% of acquired revenue. In addition we anticipate approximately 135 million of synergies in the first year. This is consistent with precedent medical device acquisition synergies and it's in-line with the synergies we achieved through our acquisition of Centerpulse. These operating synergies take into account anticipated effects of the transaction on revenues considering the cross selling opportunities together with potential disruption as the two companies are integrated. We expect revenues to grow in-line with the market in the short term post combination and when the integration is complete we would expect all categories to be growing ahead of their respective markets given the breadth of scale and the global reach of a combined sales channels. Key sources of synergies from the combination include cross selling opportunities, strategic sourcing, advanced manufacturing, simplifying instrument designs, consolidated distribution and logistics, streamline development initiatives and the elimination of redundant corporate costs. Now I would like to spend a few minutes addressing our integration approach. We recognized the Zimmer and Biomet have highly recognizable and well respected names and following a closing of the transaction the combined company will conduct business under a consolidated name that will leverage the strength of both brands. As David said earlier, this transaction is about achieving scale, innovation, synergies and growth. Slide 17, outlines in detail our key objectives of proposed high level timeline for our integration plans. We will soon establish a joint steering committee that will oversee this process across all aspects of the business as we prepare for day one success and steady state operations. We intend to capture deal value and ensure optimal execution through proactive involvement by both Zimmer and Biomet management [technical difficulty]. We’re confident in our ability to successfully integrate this transaction and we have a track record of successfully integrating companies both large and small including the major integration with Centerpulse as well as the integrations of multiple other acquisitions. While we’re on the topic of integration and before I turn the call back over to David, with the confirmation of this deal we intend to exclude amortization of intangible assets in deferred transaction related financing cost from our adjusted earnings measure post combination. For purposes of measuring the anticipated accretion on the transaction we first added back approximately 90 million of intangible asset, amortization on a pretax basis or approximately $0.40 per diluted share on an after tax basis to Zimmer’s standalone full year adjusted earnings. I will now pass the presentation back over to David for some concluding remarks.
David Dvorak:
Thanks Jim. Before we take your questions I would like to briefly recap the announced merger. We continue to adhere to our core value creation strategy to focus on growth, operational excellence and prudent capital allocation. Biomet is a perfect fit for us and the transaction is directly in-line with the strategy to create significant value and provide attractive growth and profitability over the long term. Zimmer and Biomet will create an innovation leader in the $45 billion musculoskeletal industry with a more comprehensive and scalable portfolio of solutions and cross selling opportunities. We will have enhanced musculoskeletal diversification and strong scalable platforms in faster growing sports medicine, extremities and trauma product categories. All of this increased scale will provide significant operating efficiencies and will benefit all constituents and address the evolving healthcare environment. Zimmer’s and Biomet’s market growth prospects coupled with strong cash flow will support our ongoing commitments to debt repayment and dividends. Finally all of these actions will be led by experienced management teams from both sides, with an impressive track record of successful execution and integration. We look forward to entering this exciting new chapter of our company’s history and working with the Biomet team to advance our shared goals of driving innovation to benefit stakeholders. With that I will now turn the call back over to Toni for questions.
Operator:
(Operator Instructions). Your first question comes from the line of Bob Hopkins with Bank of America Merrill Lynch.
Bob Hopkins - Bank of America Merrill Lynch:
So couple of questions I would love to ask here, first of all I want to make sure we ask the question on FTC in terms of what kind of conversations you’ve had on that front and specifically I would love to know what you think your combined market share in the United States in hips, knees and shoulder you know post-closing of the transaction.
David Dvorak:
Bob. I would tell you that we had the benefit of experts reviewing that subject matter, obviously. We're very well advised and I think the important thing to keep in mind is that this is a $45 billion industry. We’re quite confident that we will complete the transaction and at this point in time believe that the transaction be consummated in the first quarter of 2015. The market share numbers are publically available; you understand that our market share in general in most markets in knees is in the mid-20s. Biomet’s is double digits to lower teens, and in hips, our market share is closer to 20%, their market share is in similar range and that’s applicable to most geographies but as I said we’re quite confident that we’re going to be able to move through that process and that the transaction at this point in time is contemplated to be closed as of the first quarter of 2015.
Bob Hopkins - Bank of America Merrill Lynch:
And then in terms of two quick follow-ups, one I just wanted to make sure I have the earnings guidance correct. So you’re saying that in the first full year post the close double digit accretion relative to a cash EPS number and I was wondering if you could be a little bit more explicit on the double digits, I mean is that 10% to 15% or is that more, that’s one thing and then the other thing I like to ask about is relates to the guidance is on the synergies and the synergies seem to me to be about 7% of the combined companies operating expenses which seems a little late. I would expect that there might be even more synergies given that you guys are both located in the same town and then financial I was wondering are you contemplating sort of the normal hip and knee disruption that we have seen in previous mergers of maybe a little bit over 1% just would love a comment on those things and then I will drop. Thank you.
Jim Crines:
Just to be sort of more specific on what we mean by double digit accretion in a range and you’re right that it's on a something more akin to a cash earnings measure is what I indicated in my remarks, post the combination we will be adding back amortization of intangible assets as well as amortization of transaction related to financing fees to arrive at our adjusted earnings measure. We are anticipating in the range of 15% to 20% and more specifically accretion in the range of a $1.15 to a $1.25 in the first year. That does and the synergies the 270 million by the third year, 135 million by the first year. That does take into account both the cross selling opportunities that we feel are substantial with respect to the combination and anticipated disruption that will occur as a consequence of integrating the two companies on the top line. We’re not going to be more specific than that. I would just tell you as I indicated in my remarks that post the combination we would expect the top line revenues to be growing in-line with the market and then once we get through the integration we have the opportunity for all of those product categories to be growing ahead of the market. As I said given the enhanced scale and competitiveness of those various product portfolios.
Bob Hopkins - Bank of America Merrill Lynch:
And then on the synergy side just the 7% number?
Jim Crines:
I would tell you, David talked about, we see significant opportunity to be reinvesting in innovation that will include not just the sort of traditional products innovation that these companies within this industry are better known for but as well it is going to be very focused on taking advantage or the opportunity to invest more money in business model innovation. So I think it's fair to believe that the synergy opportunities are significant but as I said the combination is going to present us with an opportunity to reinvest some of those synergies and that as well is something we have taken into account in the 270 million that we have guided to.
Operator:
Your next question comes from the line of Mike Weinstein with JP Morgan.
Mike Weinstein - JP Morgan:
As a starting point can you just clarify during what Biomet’s (indiscernible) are assuming that touches about $6 billion. It sound like you’re not assuming their debt with the cash that Biomet will use to pay down their debt. So can you just clarify what balances you will be taking along?
Jim Crines:
I will tell you -- sorry Mike, somewhere in the neighborhood of net debt of estimated at around $5.5 billion that we would assume in pay down following the combination.
Mike Weinstein - JP Morgan:
And so that is not that you want to get balance sheet, I just want to make sure this is clear. So the you’re not paying, you’re not assuming that your (indiscernible) Biomet will be used to pay down that debt.
Jim Crines:
That set will be refinanced. Out of the total value 13.35 billion, as we indicated 3 billion of that will be consideration will be provided in the form of Zimmer shares and the balance in cash. So the 5.5 billion of debt that we’re going to be assuming will effectively get refinanced through the combinations.
Mike Weinstein - JP Morgan:
So you will be assuming 5.5 billion of debt and walk me through the (indiscernible) of cash comes from?
Jim Crines:
Sure. So it will come from a combination of senior notes, so it will be through the financing that we will raise which will be comprised of a combination of senior notes somewhere in the neighborhood of around 7.5 million of bond financing and 3 billion in the form of syndicated term loan.
Mike Weinstein - JP Morgan:
You’re expecting your closed offering to be about 11 billion, is that what you’re suggesting?
Jim Crines:
That’s correct. So if you take that over 10 billion that I referenced and add the 1 billion of debt that they have already on our balance sheet, total debt is somewhere north of 11 billion for the combined period.
Mike Weinstein - JP Morgan:
And you’re not assuming you'll be able to use any of your O-US cash limited cash on your balance sheet that majority is outside the U.S. is that correct?
Jim Crines:
We will be able to access somewhere between 0.5 billion to a 1 billion of offshore cash and that will go towards covering some of the -- towards funding for the combination as well as paying for some of the transaction cost associated with it, the combination.
Mike Weinstein - JP Morgan:
And then last question, just thought process on this. If I look at the first quarter activity, you bought back a lot of stock in the first quarter it looks like it's about $400 million in stock. So it didn’t look like you spent the quarter thinking about acquiring Biomet, it looks like you went along with your normal operating plan and that this came together relatively recently. Can you just talk David about what drove the decision to do this? It sounded like something that management was not inclined to do as recent recently as six months ago, conversations with the Street.
David Dvorak:
I will tell you this is very consistent with the strategic plans that we have developed over the last several operating periods Mike and the complimentary nature of these businesses allows us to accelerate many of the initiatives that are common to the two entities and so strategically this is a fit that can be seen going back sometime as these things go circumstances arise in a confluence of events that bring us to the point of actually having the capability to combine the entities and those processes once they get going can happen and need to happen in a fairly accelerated fashion. So I think you’re right, over the last several weeks it has been a concentrated effort and the perspective on what we’re going to do consistent with our disciplined capital allocation changed quite recently.
Operator:
Your next question comes from the line of Matthew Taylor with Barclays Capital.
Matthew Taylor - Barclays Capital:
I just wanted to I guess understand, you talked a little bit about some of the revenue and P&L synergies, just from a high level can you help us understand how this impacts some of the R&D projects and how you will approach selling some of it combined portfolio, are you going to kind portfolio that you’re going to kind of cheery pick some of the best products and shelf some of the other ones or should we generally view the comments about some of the pipeline activities as on track?
David Dvorak:
We will leverage the capabilities of both organizations. I think there is mutual respect for the innovation, skill sets within both of these organizations and culture as it relates to innovation. So if you think about the combination of these businesses with concentrations in various product categories and the way innovation has been conducted over the course of many years within medical devices is -- there is an element of that innovation that is committed to incremental advancements and those will always continue whether it's in the form of line extensions or the like, what this transaction allows us to do it on a combined basis is continue incremental innovation and yet have a broader portfolio and array of innovative solutions that are going to be game changing, broader in the form of joint preservation and early intervention technologies and advance the cause in preoperative and interoperative technologies that can help change the way these solutions are delivered and the efficiencies with which these solutions are delivered. So on a combined basis we’re going to be able to get after rapidly addressing more of the current unmet needs and then as Jim and both referenced in a more comprehensive way partner with other stakeholders in the healthcare industry in a manner that allows them to improve patient care and at the same time do that in a cost effective manner. So we’re going to be able to do all the things that we have done historically on a standalone basis but when combined more of it and on an accelerated basis across a broader span of the innovation opportunity and the scope of addressing the problems and challenges that other stakeholders face in an evolving health care market.
Matthew Taylor - Barclays Capital:
And just on your synergy commentary. I wanted to understand you gave us targets of 135 and 270 and talked about reinvestment, could there be upside to those synergies, are those numbers are really targeting and you would probably reinvest some of that upside if you were tracking ahead of schedule.
Jim Crines:
Yes I would just tell you that we have a very high degree of confidence in our ability to deliver on the 135 million and the 270 million. I would also acknowledge that we do believe over the long term there are going to be some significant balance sheet related cash flow synergies that are not sort of fully reflected if you will and what we anticipate to be able to achieve in the way of deleveraging over the short term. So to the extend we can execute as well on those opportunities, that’s going to provide some more opportunity for us to pay down the debt perhaps a little more quickly and drive some additional sort of accretion in bottom-line earnings.
Operator:
Your next question comes from the line of David Roman with Goldman Sachs.
David Roman - Goldman Sachs:
I want to just start with David you have made a couple of references to the quote evolving healthcare landscape, could you maybe be a little bit more specific on where exactly you see your markets going and then how this combination makes you more competitive in that marketplace than what you would have been otherwise?
David Dvorak:
Sure I think the theme to that really is we need to work in closer relationships with providers, surgeon’s integrated healthcare systems whether they are private or national and their orientation across the global. In a matter that allows us together provide better patient outcomes and solutions but at the same time do that cost effectively. This portfolio of existing products, technologies allows us to engage in those discussions and partner in ways that we believe is going to be very comprehensive and deep and to help work together towards addressing any of the challenges that exists whether it is a patient outcome challenge or a cost efficiency challenge. So for instance in the patient paradigm or algorithm to the extent that we can partner with a healthcare institution and ensure that the right intervention strategy and solution is offered to that surgeon in treating the patient irrespective of where they are in the disease state or continuum of care, all the way up through joint replacement or revision that’s a real advantage to the systems, to the extent that we can more intelligently deliver those solutions through preoperative planning systems or assist within our operative technologies to ensure that procedure goes as best as it possibly can and complications are avoided, readmissions are mitigated that’s a real advantage to that system as well as the patients. And when we refer to a comprehensive portfolio it isn't merely just the product portfolio on a traditional sense, we’re able to put together integrated services and comprehensive solutions that will enable us to partner with the other stakeholders and later bring those solutions about in a cost effective manner.
David Roman - Goldman Sachs:
And then as you kind of think about that full patient continuum of care that you referenced from early intervention to full joint replacement, is there a piece of that treatment paradigm that you really think you’re missing right now and is that something that Biomet brings to you and is there any way to sort of quantify maybe clinical revenue synergy from being able to capture a greater percentage of the patient for treatment?
David Dvorak:
I think there are absolutely platform technologies that Biomet possess that are complimentary to the ones that we possess and are continuing to develop. So it's going to be an accelerator when we are able to put those technologies and services and solutions together and I think in other dimension I neglected to state in response to the first part of your question David it's just the fact that we know that the industry that we’re serving is going to consolidate the hospital system et cetera, so they are going to be looking for saving as well by partnering with fewer vendors that can offer a fuller portfolio of solutions and that’s going to be an advantage along with these integrated services. So by way of example I would tell you that an acquisition that we did 7 or so years ago that is ORTHOsoft, that is headquartered in Montreal, they've done a terrific job of advancing preoperative technologies as well as intraoperative technologies and if you think about the deployment of these solutions, an preoperative that helps the hospital, the surgeon, the OR staff as well as this company yet the right implant, instrument set et cetera into the treatment path and then allow in a most efficient way that procedure it takes place in the OR and optimize that patient outcome and minimize the reprocessing costs and central sterilization et cetera which is what that solution base is all about that we have been developing and again Biomet is been developing services that are very complimentary to that, that can create a lot of value for everyone.
David Roman - Goldman Sachs:
Last one, just in that context we hear about cross selling and I think some companies dub it size and scale or bundling. How do you prevent the conversation from being about price and to what extent do you think I guess the scale you’re gaining here and the more consolidated nature of the hip and knee market can arrest some of the pricing decline we have seen accelerate over the past several quarters.
David Dvorak:
And I think what we’re talking about is putting together integrated solutions that have a value proposition associated with them, so by addressing unmet clinical needs, by minimizing readmissions by helping reduce infection those have incredible value creation opportunities associated with it and innovating in those regards is going to be rewarded in the marketplace.
Operator:
Your next question comes from the line of David Lewis with Morgan Stanley.
David Lewis - Morgan Stanley:
Jim, I just want to come back to a comment you made earlier about the accretion and potential disruption. I think you said that your earnings accretion does forecast some assumption for disruption, but I can't remember if it was David or yourself who mentioned that in the intermediate term you expect to grow in-line with market in your core franchises and then faster than the market in the future, which implies that you're not assuming much disruption in the near term. Can you just reconcile the revenue statement with the earnings statement?
Jim Crines:
Sure. Again I did say with respect to the revenues that in the aggregate and if you’re taking all of the various product categories we would expect in the short term post-combinations that total revenues would be growing in-line with the overall market. And then as we complete the integration our belief very firmly that we’re going to have the opportunity for all of those product categories to be growing above market. So that’s sort of in-line growth expectation for the short term as I said does take into account some anticipated disruption as we work through the integration which will impart be offset by some significant cross selling opportunities that we have as and we have talked about both in our scripted remarks and in responses to some of the questions that has been raised.
David Lewis - Morgan Stanley:
Maybe just two quick follow ups. The first interesting thing Jim for me on this transaction is you had about $200 million left on a Zimmer specific restructuring, which you were well on your pace of completing and you're talking about this transaction of having synergies of about $270 million. Can you help us understand what happens to that $200 million, is that number fully maintained? Are there opportunities to roll in Biomet into some of the ongoing activity there and maybe accelerate that $270 million number?
Jim Crines:
So I think you’re right to assume that $200 million is fully maintained. The initiatives have already been mapped out so that the project teams are assembled, the work plans are in place that they have been and continue to execute and will continue to execute obviously through the closing of this transaction and we have talked about the fact that with respect to what it takes to get from what we have already achieved that of the total $400 million that we’re targeting. The latter half of that much of that is in the manufacturing area, it gets -- take some time for that to work through the P&L and it first shows up in lower inventory cost and then eventually shows up in the P&L. So that $200 million if you reference David is fully maintained in with respect to the expectations going forward.
David Lewis - Morgan Stanley:
Just quick one for David. Just more strategic and I'll jump back in queue. David wrong, right, or indifferent, everyone's going to look to Centerpulse as the referenceable transaction for this deal, and I wonder if you could share with us just if you compare sort of the environment then versus now, the asset you're acquiring then versus now, maybe you could share sort of challenges and maybe some concerns if there are any about why Centerpulse is and is not a good referenceable transaction for this deal. Thank you.
David Dvorak:
Sure. Well I think it's a referenceable transaction with respect to the experience on integrating companies that if you look at the size of that integration relevant to where Zimmer was as a standalone entity after the spinoff back in 2003, it's relatively comparable. There is a lot of institutional knowledge and experience that resides in Zimmer today that led that transaction including Jim and I were both personally involved and highly involved in the integration, and the thing that I would say is differentiated in this regard is that the Biomet team has a terrific skillset in that regard, and a great success rate. So we’re going to partner and the steering committee and leadership to develop integration plan in a very specific way, will be balanced and representative of both organizations and as successful as Centerpulse was I’m very optimistic that this transaction will be, will come together and will take the best of the best in processes and capabilities for both of these organizations and create an even stronger entity on a combined basis. So very optimistic about how we’re going to be able to run this integration.
Operator:
(Operator Instructions). Your next question comes from the line of Matt Miksic with Piper Jaffray.
Matt Miksic - Piper Jaffray:
Couple follow-ups here. You talked about a bunch of different angles of the transaction, but Jim, I just wanted to understand, you mentioned that there are some potential further sort of cash and working capital oriented synergies with the combined organization. And I just want to understand whether those are included in your initial estimates or if things like distribution synergies or hubbing or field level kind of efficiencies of instruments and working capital are in your estimates or not at this point?
Jim Crines:
Well some of what you reference would be included in the estimated operating earning synergies, the 270 million but not at this stage reflected Matt in cash flow, it's not fully reflected in cash flow synergies to the extent that we’re going to be able to lower the amount of capital we have tied up in inventory and instrument. So that something that has to be sort of more specifically mapped out as a team has the opportunity over the next many months to get into more detailed integration planning.
Matt Miksic - Piper Jaffray:
And then again, clarification on your thoughts on some of the dissynergies. We all know that these kinds of transactions can lead to some attrition or loss of business between the two organizations. But when you talk about growing with the market it sounds like if I can read through your comments that we have two businesses that individually we would expect to be growing above market for reasons having to do with product cycles or momentum or whatever, and during this period of integration you're sort of ratcheting that back to with market to be reaccelerated again post integration. Is that a fair way to look at the growth expectations?
Jim Crines:
That’s exactly the -- precisely the right way to look at it.
Matt Miksic - Piper Jaffray:
And then finally, there were some different geographic elements of the Centerpulse deal compared to the Biomet deal in terms of complementary nature of the different kinds of organizations out there at the time. But I don't know how much detail you're willing to get into at this point, but I'd love to understand what the different characteristics are of the U.S. distribution footprint. We think of Biomet as being kind of maybe more present in the community setting and Zimmer perhaps more is present in the academic setting traditionally. Love to understand how those two organizations sort of start coming together over time and your thoughts on that would be very helpful.
David Dvorak:
Yes. I think there is a lot of complimentary aspects of the distribution channel and not just limited to the United States, OUS markets as well Matt and if you look at the product categories that is in fact the case, we haven't focused as much on what this does to us from a scale standpoint and the non-large joint categories but it's a significant difference maker when you look at the faster growing markets of sports medicine, extremities and trauma for instance and then as well we were talking about doubling the size of spine business, doubling the size of the dental business and again there is a very complimentary aspect to some of those business distribution channels for instance. Biomet’s dental business is very strong in certain OUS markets where we are relatively absent. So there is going to be a lot more to be able to talk about in that regard as we move forward Matt but we see it as a terrific opportunity as well as big dimensions of cross selling capabilities with the relationships that exist across those various markets and you take a business unit like our surgical business that really isn't fully built out and Biomet’s portfolio and we’re going to be able to cross sell those products successfully into those accounts and relationships. And as Jim referenced earlier some of the earlier intervention and joint preservation technologies that are part of our portfolio are going to be successfully sold into their sports medicine. So I think there are going to be wonderful opportunities with a broader portfolio, the leverage of those relationships and capabilities across the globe and across the various product categories.
Operator:
Your next question comes from the line of Derrick Sung with Sanford Bernstein.
Derrick Sung - Sanford Bernstein:
Starting with the transaction, I was wondering if you could give us any color on whether this might have been any kind of -- any sort of competitive bidding process involved with the deal and if there might be any provisions within the deal to prevent a competitive bidder from stepping in.
Jim Crines:
We have obviously as the securities fillings -- there will be a full element of disclosure embodied in those documents and the background of the process and I don’t want to speak on behalf of the Biomet organization in that regard Derrick, but you'll gain whatever insights that disclosure will reveal about the background and process here. Suffice to say that transaction agreements provide support from the major sponsors and that disclosure will be very specific as well but we’re very confident in the ability to consummate the transaction.
Derrick Sung - Sanford Bernstein:
And as you think about your portfolio and the portfolio that Biomet has, there's obviously a lot of overlap there in your hip and knee categories, but there are obviously some differences here, and I was wondering if you could talk about what aspects perhaps of the Biomet portfolio you're most excited about. Obviously they're coming out with their bicruciate knee. And then longer term, do you envision continuing to basically have two sort of lines of offerings if you will, or is there a longer-term opportunity to maybe streamline your product portfolio as the integration unfolds?
David Dvorak :
I think that the comprehensive nature of the portfolio is pretty recognizable if you move up and down the continuum of care Derrick. I think that as we have expressed there are early intervention technologies and joint preservation technologies for example our Gel-One product on the front end of that continuum of care and there are sports medicine products and technologies on the front end of that continuum all the way through comprehensive revision systems and salvage systems. So you can line that up, plot whatever point on that continuum you’re most interested in and you’ve a terrific offering when this come together that I think is going to really be a difference maker for the customers that we’re partnering with. So I think that that is an incredible benefit that’s going to be seen as very valuable from the customer’s perspective.
Operator:
Your final question comes from the line of Joanne Wuensch with BMO Capital Markets.
Joanne Wuensch - BMO Capital Markets:
Just a simple question. Have you put contracts in place to hold people into place? And how are you dealing with employees at this stage? Warsaw can be seen as a small community. Thank you.
David Dvorak:
Sure Joanne. We will be very proactive on that front, there will be programs put in place to address any of the risks that you just referenced. I think that overall as it relates to your second question, Warsaw, this transaction cements Warsaw as at a global basis the musculoskeletal innovation capital of the world and we’re going to be able to accelerate the planning and upon consummation of the deal accelerate the integration efforts to leverage the fact that the value systems are very common, the geography is going to be beneficial. The commitment customers and enhancing the quality of life for patients provide such a common bond and platform to bring these organizations together that we're extraordinarily confident in our ability to address the risks and leverage the opportunities that this combination represents.
Joanne Wuensch - BMO Capital Markets:
Thank you very much and congratulations.
David Dvorak:
Thank you Joanne. So with that I would just state that we very much look forward to speaking with you on our second quarter conference call which is scheduled for 8 a.m. on July 24. I will turn the call back to you Toni.
Operator:
Thank you for your participation in today’s conference call. You may now disconnect.