Agreement to Acquire Spinal Kinetics, Inc. March 15, 2018

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Transcription:

Agreement to Acquire Spinal Kinetics, Inc. 1 March 15, 2018

2 SAFE HARBOR STATEMENT AND USE OF NON GAAP MEASURES

WHY SPINAL KINETICS? The Spinal Kinetics M6 artificial discs further round out Orthofix s portfolio by filling the most significant gap in our Spine Fixation product line 3

4 SPINE FIXATION PORTFOLIO

Orthofix will acquire Spinal Kinetics, Inc. by merger DEAL SUMMARY Orthofix will pay $45 million cash at closing plus potential milestone payments of: $15 million, payable upon receiving U.S. FDA approval $15 million, payable upon achieving trailing twelvemonth revenue of $30 million worldwide $30 million, payable upon achieving trailing twelvemonth revenue of $50 million worldwide Closing anticipated to be Q2 2018, subject to customary closing conditions Note: All milestones must be achieved within 5 years of the closing date 5

STRATEGIC RATIONALE Positions Orthofix as a mid to high single digit growth company Fills the most significant product gap in the Orthofix Spine Fixation portfolio Cervical disc replacement is a high growth segment of the spine market No product or sales force duplication Proven cervical and lumbar discs with over 54,000 implanted since launch in 2006 Motivates the current sales force and attracts new sales talent Stand alone acquisition with low integration risk Leverages current momentum, management team, sales force and balance sheet 6

U.S. CERVICAL DISC MARKET U.S. Cervical TDR Market Forecast 2017 U.S. Cervical Disc Market Share $M $350 Globus 2% NuVasive 2% $300 $250 $200 $150 Medtronic 19% 17% Centinel Spine* 40% $100 $50 $- 2017 2018E 2019E 2020E 2021E LDR/Zimmer 33% Zimmer Biomet 37% Source: SmartTRAK 2017 Actuals Source: SmartTRAK 2017 Actuals *Recently sold by DePuy/Synthes 7

ABOUT SPINAL KINETICS Company Established in 2003, based in Sunnyvale, CA Experienced management team and manufacturing expertise 2017 OUS revenue of approximately $15 million The M6 is a top selling disc in Europe Leading spine surgeon KOLs involved in clinical evaluation and U.S. trial Technology Innovative technology first artificial disc designed to match the physiologic characteristics of a natural disc Closely matches biomechanical loaddisplacement curves of natural discs Completed single level clinical trial comparing M6 C to cervical fusion in 258 patients PMA modules submitted 2017, expect U.S. FDA approval mid 2019 Issued and pending U.S. patents covering the technology 8

CURRENT ARTIFICIAL DISC TECHNOLOGY Currently marketed discs are based on artificial hip ball and socket technology Artificial Hip Artificial Disc Ball and socket designs do not anatomically match natural disc movement 9

KEY ATTRIBUTES OF A NATURAL DISC Anatomic Structure Nucleus for compression Annulus for motion control in all planes with Progressive resistance Annulus Nucleus pulposus Physiologic Motion 6 Degrees of Freedom Independent motion in all planes and axes Dynamic Center of Rotation variable with spinal level & during motion 10

KEY ATTRIBUTES OF A NATURAL DISC The M6 is designed to mimic the physiologic characteristics of a natural disc Natural Disc M6 Artificial Disc 11 Annulus Nucleus

PIVOTAL STUDY OUTCOMES 60 55.4 Mean NDI Score M6 C 8 7.3 Mean Neck Pain VAS M6 C 50 7 6 40 5 30 4 20 10 21.4 14.5 11.6 11.1 13.6 3 2 1 2.1 1.3 1.4 1.3 1.4 0 Pre Op Week 6 Month 3 Month 6 Month 12 Month 24 0 Pre Op Week 6 Month 3 Month 6 Month 12 Month 24 NDI = Neck Disability Index VAS = Visual Analogue Scale 12 Source: The Spine Journal 17 (2017) S89 S110. Title: M6 C Artificial Cervical Disc: Two Year Follow Up at Five IDE Investigational Centers

EXPECTATIONS Projected Adj. EBITDA & EPS accretive within 12 months of U.S. approval Projected deal Adj. ROIC to exceed cost of capital within 24 months of U.S. approval 2018 Stand Alone Orthofix 2018 Spinal Kinetics Impact* 2019 Spinal Kinetics Impact** Sales of $450 to $455 M Adj. EBITDA of $89 to $91 M Adj. EPS of $1.76 to $1.84 Sales of $8.0 to $9.0 M Adj. EBITDA of ($3.0) to ($3.5) M Adj. EPS of ($0.16) to ($0.18) Sales of $16.0 to $18.0 M Adj. EBITDA of ($3.0) to ($5.0) M Adj. EPS of ($0.14) to ($0.22) 13 * Assumes May 1, 2018 closing date ** Assumes July 1, 2019 PMA approval

THANK YOU NASDAQ: OFIX WWW.ORTHOFIX.COM INVESTOR RELATIONS MARK QUICK markquick@orthofix.com ORTHOFIX INC. 2018 14