Investor Presentation

Transcription

1 Investor Presentation July 11 th, 2017 Empower surgeons to enhance clinical outcomes and simplify surgeries bringing real time digital technology into the Operating Room

2 Stephane Bette becomes CEO Pierre Jérôme Co-founder, CEO and Board Director 25 years of experience in the medtech industry (Europe and USA): Medtronic Sofamor Danek, Boston Scientific, SpineVision sales & marketing, business development, general management Alan Olsen Chairman of the Board Founder of Danek (now Medtronic Spine) 25 years experience Investor and Board director in Medtech Master degree in Management from the INSEEC School of Business Bordeaux, France Stéphane Bette Co-founder, CTO, US GM and Board Observer 20 years of experience in spine (Europe and USA): Sofamor Danek R&D, SpineVision founding employee, VP R&D and US GM Master degree in Mechanical Engineering (ENSAM), Post-graduate in Biomechanics (LBM) Maurice Bourlion Board Director and SAB Member Co-invented Dynamic Surgical Guidance and Electro-Conductive Shock Wave Lithotripsy Extensive experience in R&D, international marketing and business development in the medtech industry Manuel Lanfossi Chief Financial Officer Pierre Guyot Board Director Joined SpineGuard in March years of experience in finance, M&A and strategic planning, 17 in life sciences (Dade-Behring, ev3) 30 years of experience in the international healthcare industry, Until 2014, Pierre was the CEO and a member of the board of directors of Mölnlycke Health Care Transition effective on July 13 th, PJ remains at SG s Board of Directors With focus on strategic partnerships and international business 2

3 Accelerate path to profitability 1 2 PediGuard legacy solid business foundations DSG enabled solutions for spine implant placement 3 Cutting edge pipeline in spine and beyond PediGuard legacy solid business foundations DSG enabled solutions for spine implant placement Cutting edge pipeline in spine and beyond Full line of single use smart drilling probes for spine fusion >55,000 surgeries performed and 10 clinical publications Cleared in EU, USA, Brazil, Russia, Japan, China where we just signed a DA with XR Medical 7.5m revenue in 2016 with 22% CAGR and 85% GM. 16% growth 1H17 Strong footprint in the US and France, 40+ distributors WW Disruptive innovation within $7bn spine fusion market Partnership distribution strategy, 2 non-exclusive partners CE marked & FDA cleared, now in alpha launch Fit with reimbursement schemes Replicable business model Robotic surgery real-time safety feedback loop X-Ray Free Navigation Bone Quality Measurement Non Spine: Ortho recon., Trauma, Maxillo-Facial, Dental: just signed Adin Efficient legacy business, deploy smart screw & trigger deals 3

4 SpineGuard core technology: Dynamic Surgical Guidance (DSG ) Enabling technology to secure implant placement in bony structures External electrode Local electrical current Bipolar sensor Internal electrode The bipolar sensor: local real-time measurement and transcription of electrical conductivity 4

5 PediGuard : Single use DSG drilling probes for Spine Cervical Straight Curved Cannulated Threaded Thoraco Lumbar Launched in 2016 Complete range for Spine Next step: addition of digital signal visualization and recording 5

6 Clinical value established via 10 peer reviewed publications Alternative techniques Rate of poorly positioned screws Sensitivity 1, PediGuard vs. EMG Conventional method Surgical navigation max 32% Significant benefits in terms of accuracy 84% 50% 98% High reliability EMG (Electromyograph y) 15% min max 6% 5% min max 5% 1% min PediGuard Best in class accuracy 25-30% reduction in radiation exposure 15% less time inserting screws Data resulting from systematic review of the specialized scientific literature with all references listed at the end of SpineGuard s clinical brochure Lumbar EMG Thoracic EMG Thoracic & Lumbar PediGuard 6

7 DSG brings solutions to all stakeholders Patients Surgeons Hospitals Less risk of neurological and vascular consequences associated with misplaced screws Reduced risk of exposure to radiation, which can be especially beneficial in young patients Minimized chance of infection from reduced use of ancillary equipment Operator is in complete control of surgical procedure without the need for any input from professionals outside the surgical field Decreased risk of health hazards associated with repeated exposure to radiation Real-time feedback helps surgeons significantly minimize potential complications Enhanced resident and fellow learning environment Financial accountability of hospitals when corrective surgery is required No investment in specialized personnel or equipment Reduces operating time and easy integration with no change in surgical workflow procedure Minimizes risk of patient litigation resulting from medical error Convenience of ready-to-use instruments with no maintenance and sterilization A compelling value proposition for the entire healthcare system 7

8 Marketing leaning on KOLs, clinical data & education SAB 8

9 Legacy business update USA & France: HQ in Paris & San Francisco - Direct through independent sales agents and strong field presence Rest of the world: Indirect via national stocking distributors, focus on top 10 countries Direct organization Strong management team driven by co-founder 3 regions led by a sales manager and product specialist 15 employees primarily in sales & marketing Tools in place to answer changes driven by HC reform >30 users in France (18 CHUs) Good momentum in Europe Education effort toward Russian surgeons mitigated by economic context Japanese distributor faced difficulties with their implant line Coverage ~80 agencies ~130 accounts Distribution agreement signed with XR Medical mid-june National and regional contracts signed with US Hospital systems (HCA, Spartan, ) National Distribution Agreement with OrthoPediatrics for Pediatric Institutions Change of distributor in Brazil with new regulatory strategy Large tender in Gulf countries Former Stryker executive team Backed by Blackstone Focus on education Upfront and commitment on minima Leveraging our solid foundations in selected countries 9

10 Q2-09 Q3-09 Q4-09 Q1-10 Q2-10 Q3-10 Q4-10 Q1-11 Q2-11 Q3-11 Q4-11 Q1-12 Q2-12 Q3-12 Q4-12 Q1-13 Q2-13 Q3-13 Q4-13 Q1-14 Q2-14 Q3-14 Q4-14 Q1-15 Q2-15 Q3-15 Q4-15 Q1-16 Q2-16 Q3-16 Q4-16 Q1-17 Q2-17 A qualitatively steady growth of adoption revenue: 7.5m up 18% vs with 8,603 units sold 1H17: 16% growth at 4.2m and 4,264 units sold US +18 French teaching institutions have adopted PediGuard Over 55,000 surgeries performed worldwide (half in the US) Legacy business model delivering sustained double digit growth 10

11 Poorly-placed screws induce major risks and costs Biomechanical Neurological Hemorrhagic Cost implication Poorly-positioned screws may require a 2 nd surgical procedure Pseudarthrosis: poor fusion Paralysis if the spinal cord is breached Neurologic consequences if the nerve roots are touched Fatal hemorrhaging if the aorta is punctured Complications that are difficult to detect Based on 3 US economic studies, the additional cost for revision surgeries to correct misplaced screws ranges Screw misplacement: 15-32% Complication rate: 2 to 11% Revision rate due to screws at risk for the aorta: 2-6% From $17,650 to $27,677 OR teams exposed to excessive radiation doses and aware of its danger Long-term biological effects Spine surgery 10 to12x more exposure to X-ray than with other surgical procedures Healthcare reforms seek risk elimination & procedure efficiencies Data resulting from systematic review of the specialized scientific literature with all references listed at the end of SpineGuard s clinical brochure 11

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13 A large market in need of innovation and differentiation Orthopedic surgery > $40 billion Spine surgery ~$10 billion Vertebral fusion ~$7 billion (2/3 are screws) ~400 comparable screw systems on a mature and ultracompetitive market Surgery Pedicle screw market split CAGR Annual number of procedures Open degenerative Minimally-invasive surgery 62% 12% +3% +10% >700,000 Deformities 8% +5% >80,000 Trauma & tumors 8% +2% >80,000 Posterior cervical 8% +7% >80,000 Dynamic stabilization 2% +15% ~ 20,000 Spine Fusion: Over 1 million surgeries and 5 million screws to secure Sources : William Blair, Spine Technology Summit and I-DATA 13

14 DSG Screw deployment Partnership with Neuro France Implants 1 st surgeries in Europe Development process Partnership with Zavation Design validation 1 st surgery in the US Regulatory process 75 LR surgeries performed so far Preparing for launch at NASS in October Unique combination of a bipolar sensor and a pedicle screw in just one device. 14

15 DSG enabled Pedicle Screw unmatched value Clinical value Economic value Strategic value Ultimate accuracy improved success rates Fits with existing reimbursement landscape for pedicle screws Adaptable to various pedicle screw instrumentations Enhanced screw purchase/anchorage Clinical workflow efficiency skip steps save time and cost Clear pathway to commercialization Minimizes radiation exposure More defensible price vs. legacy screws in a >1m procedural market in Spine alone Highly differentiated scope to capture market share aggressively DSG Screw, one of the best new spine technologies for 2016 (Orthopedics This Week Spine Technology Award) 15

16 Emerging spine robots: a clear opportunity for DSG Medtronic/Mazor Mazor X J&J / BrainLab Stryker - MAKO Globus Excelcius News: CE marked Jan 2017 Zimmer - Rosa Tinavi Ti Robot News: CFDA cleared in Nov 2016 KB Medical AQ rate 16

17 DSG value for robotics demonstrated 17

18 Dental: 3 targeted indications for 8M procedures 18

19 Broadening our technology scope X-RAY FREE NAVIGATION Novel ultrasound technology Complete DSG for a full guidance solution in MIS and open surgery 100% X-ray free approach 2 patent applications Partnership with a leading ultrasonic transducer manufacturer BONE QUALITY MEASUREMENT Assess precisely the local bone quality / density Overcome DEXA scans lack of accuracy Allow surgeons to make intra-op decisions on treatment 2 patent applications Opportunities beyond Spine Bringing new solutions to unmet clinical needs 19

20 Wrap up 4 Robotic safety loop in Spine Other non Spine applications Bone Quality Measurement X-Ray Free navigation High potential pipeline 3 Drill for Dental Implants Leverage DSG platform via deals 2 DSG Enabled screws for Spine Deploy smart screw 1 Full range of PediGuard smart drilling probes in Spine Optimized legacy business A clear strategy to establish DSG as standard of care, drive growth, reach profitability and create shareholders value 20