Investor Presentation

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1 Investor Presentation February 2015

2 General Disclaimer This presentation contains forward-looking statements about the Company s business and prospects. Such forward-looking statements are based on numerous assumptions regarding the Company s present and future business strategies and the environment in which it will operate in the future, which may not be accurate. Such forward-looking statements also involve known and unknown risks, uncertainties and other factors which may cause the Company s actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical facts included in this presentation, including, without limitation, those regarding the Company s financial position, business and regulatory strategy, plans and objectives of management for future operations (including development plans and objectives relating to our products), are forward looking statements. They can generally be identified by the words believe, expect, anticipate, intend, will, may, would, could and plan and similar expressions. Risk factors include, among others, risks associated with development and commercialization of the Company s products, uncertainties related to the U.S. FDA approval process, the outcome of clinical trials, market acceptance of the Company s products, its ability to manage growth, the competitive environment in relation to its business area and markets, its ability to enforce and protect its patents and proprietary rights, and other factors, including those described in the Section 4 Risk Factors of the Company s 2011 Registration Document Update (Actualization du document de reference) filed with the Autorité des marches financiers (the AMF ) in France on August 27, 2013 under number R The Company does not undertake and expressly disclaims any obligation to update or revise any of these forward-looking statements, whether to reflect new information, future events or circumstances or otherwise. The forward-looking statements in this document speak only as of its date. If you wish to obtain further information about STENTYS, please refer to our website This presentation does not constitute an offer to sell, or a solicitation of an offer to buy, STENTYS shares. 2

3 Management team Gonzague Issenmann, MSc, MBA Chief Executive Officer & Co-founder Co-founded STENTYS and has been leading its development Formerly at Cordis, Johnson & Johnson INSEAD, MBA, Ecole Centrale Paris Stanislas Piot Chief Financial Officer Background in Investment Banking & Equity Capital Markets Previously CFO of Ipsogen Graduate of finance and economics at the University Paris II 3

4 STENTYS: the emerging coronary stent player Large market driven by growth in acute care $7 billion market by the end of the decade, with more than half in AMI* Unique and differentiated technologies Self-Apposing stent adapts to varying diameter vessels to solve problems of malapposition observed with conventional stents MiStent SES unique drug-delivery technology with bioabsorbable coating slows downs disease progression Excellent clinical results in key indications APPOSITION program in AMI showed lowest mortality rate in 1,000 patient trial and faster arterial healing than balloon-expandable stents DESSOLVE program showed very low number of repeat-procedures compared to market leading workhorse stents Company built for growth Three major product launches in the next 12 months Global and fast-increasing distribution network Demonstrated ability to acquire new technology and sign strategic deals *Acute Myocardial Infarction or heart attack 4

5 Company journey 35 employees in 10 countries HQ in Paris, France and Princeton, NJ Company co-founded by J. Séguin, founder of CoreValve FDA approval for US BMS trial Successful 36.4m rights issue CE Mark on BMS/PES IPO on Euronext Paris Launch of STENTYS SES Launch of MiStent Launch of new generation delivery system Results of APPOSITION III at 2 years and APPOSITION IV CE Mark on SES stent Development Regulatory Market Preparation Expansion 5

6 Coronary stent market: a shift to acute treatment $5 bn $6 bn $7 bn $2 bn $ 3 bn $ 4 bn Heart attack (acute myocardial infarction or AMI) Treatment by drugs (thrombolitycs) Stents replace drugs Emerging markets Source: Company estimates based on various market studies, Including MedMarket Diligence 6

7 Innovations will keep driving market dynamics $5 bn $6 bn $7 bn Bare metal stents Drug eluting stents $2 bn Specialty stents INNOVATIONS Bare Metal stents Drug eluting stents Self-Apposing Bioresorbable Source: Company estimates based on various market studies, including MedMarket Diligence 7

8 STENTYS coronary stent portfolio offers solution to all patient needs Specialty stents For patients with vessels where the diameters varies along its length or over time, such as in AMI Conventional stents For all other patients, best and latest 3 rd generation drugeluting stent (DES) SES: Sirolimus-eluting Stent 8

9 STENTYS Self-Apposing Stent Self-expanding nitinol stent designed to appose to artery wall, completely and continuously Disconnecting struts for side-branch access Bare or Sirolimus-eluting with biostable polymer Disconnectors along the stent Disconnectable interconnector Disconnection 9

10 Imprecise Stent Size Selection during AMI increases risk of re-clotting and heart attack 2 Artery contracts/ presence of thrombus Implantation Artery Relaxes 3 / thrombus disappears Normal Stent too LARGE Artery Clot Stent too SMALL VESSEL INJURY MALAPPOSITION Gap Malapposition 2 Causes of Early Stent Thrombosis in Patients with ACS 3 APPOSITION I trial demonstrated 19% vessel growth between 0 and 3 days 10

11 Self-Apposing stent solves the sizing dilemma and adapts to the vessel 3 Artery contracts/ presence of thrombus Implantation Artery Relaxes/ thrombus disappears Normal Artery Clot 3 APPOSITION I trial demonstrated 19% vessel growth between 0 and 3 days 11

12 STENTYS SES indications Clinical Indication: Vessel diameter varies over time Anatomical Indication: Vessel diameter varies over its length Acute Coronary Syndrome Bifurcation By-pass grafts Large vessels Ectatic vessels Tapering vessels 12

13 STENTYS clinical trials Vessel diameter varies over time Vessel diameter varies over its length APPOSITION Program: 5 trials over 1,500 patients enrolled OPEN Program: 2 trials 265 patients enrolled ADEPT trial: 60 patients Acute Coronary Syndrome Bifurcation By-pass grafts SIZING registry: over 700 patients enrolled SIZING registry: over 700 patients enrolled SIZING registry: over 700 patients enrolled Large vessels Ectatic vessels Tapering vessels 13

14 APPOSITION IV: Faster healing than conventional DES DESIGN: Prospective, randomized, twoarm, multi-center study OBJECTIVE: To compare the endothelization of the STENTYS SES with a balloon-expandable DES in AMI ENDPOINTS: Late malapposition (9 months) Strut 4 and 9 months MACE up to 12 months STENTYS Sirolimus OCT & QCA at 4 months 150 STEMI patients Medtronic RESOLUTE OCT & QCA at 9 months Clinical FU at 12 months Stents with all covered struts at 4 months Balloon Expandable Stent 4 m STENTYS Stent 4 m 40,0% STENTYS P= ,0% 31,6% 3,8% 0,0% Resolute Late Lumen Loss at 9m: 0.04mm Presented by Dr. van Geuns at PCR

15 Strategic acquisition for next-generation delivery system Acquired from Cappella Inc. Clinically proven Replicates Conventional Stent Implantation Technique small balloon inflation splits open the stent-containing sheath. Current generation Next generation Launch scheduled for H

16 Strategic distribution agreement with Micell Technologies Micell Technologies: US cardiovascular company that developed technology to enhance the performance of medical devices with innovative drug-delivery systems. Private company shareholders include St Jude Medical and GE Long-term distribution agreement 5-year exclusivity on distributing MiStent SES worldwide (excluding United States, Canada, China, South Korea and Japan) MiStent SES is already CE Marked Partnering on DESSOLVE III post-market study 16

17 Drug Polymer Redefining Drug Delivery to Match Vessel Response to Injury Hours Days Weeks Months Thrombosis Inflammation Proliferation Extracellular Matrix Production Short Term Polymer presence to help protect from Thrombosis. Controlled, gradual and sustained drug release to minimize inflammation and cellular proliferation 17

18 Drug Elution (days) A new category: Sustained Drug Release with Short Term Polymer Presence Polymer delivers Drug Bubble Size represents Strut Thickness 250 MiStent Biomatrix & Nobori Synergy Orsiro Polymer elutes Drug Polymer Presence (days) 18

19 MiStent SES: the best 3 rd generation stent Cobalt Chromium Thin strut (64µm) stent design on a low profile, highly deliverable system PLGA Absorbable Polymer Coating (9.6µm) designed to be cleared off the stent in days and from the tissue within 90 days Crystalline sirolimus designed to provide sustained drug release up to 9 months 19

20 % Target Lesion Revascularization Cross-Study Comparison: Slower Disease Progression, low rate of repeat procedures ,4 2,7 4,6 1,3 1,3 0, Time (Months) 5,4 2,0 Abbott Xience (Spirit III) MiStent DESSOLVE I+II pooled (150 patients) 8,6 20

21 Direct sales structure in place Marco Gario International Sales Director Italy CM Northern Europe Switzerland CM Germany CM Poland CM Int. Sales Support France CM Product Specialist 1 Sales Rep Sales Rep Sales Rep Sales Rep Product Specialist 2 21

22 Over 30 countries to date Europe Middle East South America Denmark France Serbia Romania Egypt Jordan Argentina Sweden Germany Italy Poland Tunisia Turkey Chile Spain Finland Austria Switzerland Asia UK Norway Netherlands Greece Koweït Saudi Arabia Hong Kong Singapore Czeck Republic Estonia United Arab Emirates Malaisia 22 22

23 Below The Knee: the peripheral opportunity DESIGN: Prospective, non-randomized, single-arm, multi-center trial OBJECTIVE: To evaluate the immediate and long-term outcome of the Paclitaxel-Eluting STENTYS Stent System in < 50 mm lesions Primary Endpoint: Primary patency at 12 months (under angiography, verified by Core Lab) Inclusion Criteria: Rutherford class 4 or 5 Independent monitoring: FMRP Principal Investigator: Dr Bosiers 70 patients enrolled in 5 European clinical sites Clinical follow-up at 6 months Clinical and angiographic follow-up at 12 months Results at 12 months Primary Patency 73% Freedom from TLR 79% Survival 89% Freedom from amputation 99% Presented by Dr M. Bosiers at LINC

24 Financial summary at end-2014: revenues & cash position Revenues Sustained revenues growth in 2014 : up 13% vs to 3.9m Sound cash position: 18.6m at 31 December

25 Financial summary: P&L Thousands of Euro 30/06/ /06/2013 Sales 1,935 1,638 Revenues 1,935 1,638 COGS -1, Research expenses - 4,227-1,774 Sales & Marketing expenses - 2,784-3,146 G&A expenses -1,523-1,244 Current Operating result (before Payment in shares) -7,778-5,461 Payment in shares APPOSITION V Accrued expenses (Non Current Provision) - 5,328 Operating result (after Payment in shares) - 13,339-5,809 Financial result Net Profit/(Loss) - 13,190-5,693 APPO V costs recorded during HY 2014 represent 2.4m To respect FDA clinical trial commitments, a 5.3m provision has been recorded 25

26 Financial summary: Consolidated Balance Sheet Thousands of Euro 30/06/ /12/2013 Cash and equivalent & other current financial assets 23,081 31,872 Current assets 4,801 4,637 Non current assets 4,742 3,591 Total assets 32,624 40,100 Shareholders equity 22,294 34,676 Financial debts 1,122 1,297 Other liabilities 9,208 4,127 Total liabilities and shareholders equity 32,624 40,100 Strong cash position: 23.1m Non current assets increase due to Cappella Peel Away acquisition ( 1m) Other liabilities take into account the provision for the FDA trial commitments Inventory depreciation: 0.97m Short term Provision: 2.13m Long term Provision: 2.26m 26

27 Financial summary: Cash Flow Statement Thousands of Euro 30/06/ /06/2013 Cash used in operating activities -8,003-5,894 Cash used in investing activities Cash provided by financing activities Net increase/(decrease) in cash - 8,791-6,576 Effect on exchange rate changes 0 0 Cash at the end of the year/period 23,081 39,054 27

28 STENTYS BTK STENTYS SES 18-Month Objectives & Planned News Flow H E H E H E Continued commercial launch of the Sirolimus-eluting Self- Apposing stent in EU Launch of next generation delivery system Continued product registration and launch outside EU MiStent SES Launch of MiStent SES Start of DESSOLVE III clinical trial Continued product registration and launch outside EU CE Mark for BTK indication Selection of distributors in EU and Middle East Launch of additional stent sizes 28

29 Gonzague Issenmann Chief Executive Officer and Co-Founder Stanislas Piot Chief Financial Officer Tel: INVESTOR RELATIONS: Europe: NewCap, Dusan Oresansky / Pierre Laurent stentys@newcap.fr US: LifeScience Advisors, Andrew McDonald andrew@lifesciadvisors.com

30 Appendix

31 Share Information ISIN: FR Ticker: STNT - CAC PME Listing place: Euronext Paris (Compartment B) Number of outstanding shares: 11,721,371 Share price: 6.34 (12 February 2015) 12-month low/high: month average trading: 110,235 shares a day J. Séguin / G. Issenmann 4% Bpifrance Participations 7% SEP 5% Omnes 2% Sofinnova 9% Market capitalization: 74.3 million Liquidity contract: Gilbert Dupont (Paris) Free float 73% 31

32 Experienced international leadership Gonzague Issenmann Chief Executive Officer Formerly at Cordis, Johnson & Johnson Co-founded STENTYS and has been leading its development since Holds an MBA degree from Insead Stanislas Piot Chief Financial Officer Background in Investment Banking, Equity Capital Markets Previously CFO of Ipsogen Graduate of finance and economics at the University Paris II Marco Gario International Sales Director.Previously STENTYS Country Manager Italy Over 20 years in Marketing and Sales functions Dr René Spaargaren, MD Chief Medical Officer Previously at ev3 as VP of International Clinical Affairs Served for seven years ( ) with Boston Scientific Served for three years ( ) with Medtronic Luc Morisset Director of Regulatory Affairs Over 20 years of experience in EU regulatory affairs Previous roles at Ministry of Health (France) and MedPass Graduate of Compiegne University (UTC), degree in biomedical engineering Hikmat Hojeibane Chief Technology Officer More than 19 years experience in R&D in the medtech industry Previous roles at Johnson & Johnson, B Braun, CR Bard, Cryocath Specialised in the development of advanced stent and catheter technologies 32

33 Board of Directors Michel Darnaud Chairman President of the Sorin s Cardiopulmonary and Intercontinental business 30 years of industry experience in medical technology Marie Meynadier Independent board member CEO of Eos Imaging 25 years experience in IT and lifesciences innovation Electrical Engineering, Sup Telecom Paris, PhD at Ecole Normale Supérieure Paris Antoine Papiernik Sofinnova Partners Started career in private equity in the Caisse des Dépôts group Initial investor and active board member in a many EU/US companies MBA from the Wharton School of Business, University of Pennsylvania Dr Michael Lesh, MD Independent board member Founder and CEO of Middle Peak Medical Founded three successful medical device companies since 1997 Served on the Board of Directors of several medtech companies Dianne Blanco Independent board member CEO of Orteq Sports Medecine Former President of the Baxter European division MBA from the Northwestern University Kellogg Graduate School of Management Gonzague Issenmann Chief Executive Officer Formerly at Cordis, Johnson & Johnson Co-founded STENTYS and has been leading its development since Holds an MBA degree from Insead 33

34 Support from world s most prominent cardiologists Scientific Advisory Board and US advisors Raoul Bonan, MD Associate Professor of Medicine, Montreal University, Canada Roxana Mehran, MD MD at NewYork-Mount Sinai Co-director of the Clinical Trial Center at the CRF Stefan Verheye, MD Senior Interventional Cardiologist at the Antwerp Cardiovascular Institute, Middelheim Hospital, Belgium Maurice Buchbinder, MD Professor of clinical medicine, Stanford University Martin Rothman, MD Professor of Interventional Cardiology, Director of Cardiac Research & Development, The London Chest Hospital, UK Martin Leon, MD NewYork-Presbyterian Hospital at Columbia University, NY Chairman of the CRF Eberhart Grube, MD Chief of cardiology,university Hospital Bonn, Germany Consulting professor of medicine at Stanford University Patrick W. Serruys, MD Chief of interventional cardiology at the Thoraxcenter-Erasmus University, Rotterdam, The Netherlands Alan Yeung, MD Chief (Clinical), Division of Cardiovascular Medicine, Stanford University School of Medicine, CA Thierry Lefevre, MD Head of interventional cardiology and research at ICPS Jacques Cartier, Massy, France Gilles Montalescot, MD Head of the Cardiac Care Unit at Pitié-Salpétrière Hospital in Paris Donald Cutlip, MD Cath lab Director, Cardiovascular Institute at Beth Israel Deaconess Medical Center, Boston, MA 34

35 Intellectual Property: A Strong Barrier to Entry 51 patents filed with broad claims and worldwide coverage USA France EU Japan Canada Other Total STENTYS Cappella Peel Away Total IP protection: A self-expanding stent in heart attack (mesh size + artery size) Disconnecting stent Split sheath 35

36 Stents have 2 very different indications 1. Chest pain (angina) Chest pain (angina) Cholesterol plaque = artery narrowing Slowly evolving condition (chronic) Stents widen arteries Provide pain relief Narrowed artery Stent widens artery Heart attack (acute myocardial infarction) 2. Heart attack (acute myocardial infarctio Acute blood clot: artery blocked Imminent death: emergency intervention Stents restore blood flow Patient saved, but at risk of heart attack recurrence Clot 36

37 Stent Sizing in AMI: A Recognized Concern 1 Operators performing primary PCIs in STEMI should be aware of the importance of selecting an appropriate stent size. Most patients with STEMI have some degree of coronary spasm and, thus, intracoronary administration of nitrates is recommended before starting the coronary angiographic sequence used for stent size selection. The presence of thrombus can also lead to stent undersizing (or otherwise suboptimal deployment), which is a frequent cause of re-stenosis or stent thrombosis in reallife practice. 1 European Society of Cardiology Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation (European Heart Journal doi: /eurheartj/ehs215) 37

38 Causes of Early Stent Thrombosis in Patients with ACS OBJECTIVE: to investigate the histopathology of early Stent Thrombosis (ST) in Acute Coronary Syndrome (ACS) patients with DES or BMS implantation. METHODS: Histologic cross-sections prepared at 3 mm intervals were evaluated for stent thrombosis which was defined as platelet-rich fresh thrombus occupying >30% of the lumen area. Independent lab and statistical analysis: CVPath (R. Virmani) 67 lesions from 59 patients presenting with ACS and dying within 30-days (CVPath Human Autopsy Stent Registry) Early ST N=37 (19 DES and 18 BMS) Histological assessment No thrombosis N=30 (18 DES and 12 BMS) 35% 30% 25% P=0.008 P=0.004 P< % 15% 10% Malapposition Medial Tear Necrotic Core Prolapse 5% 0% Malapposition Medial tear Necrotic Core prolapse Thrombosis Control M Nakano et al. JACC doi: /j.jacc

39 APPOSITION I DESIGN: Prospective, non-randomized, single-arm, multi-center trial OBJECTIVE: To evaluate the safety and performance of the STENTYS self-expanding coronary stent system in AMI ENDPOINTS: Stent apposition and expansion after 3 days MACE during hospitalization 30 days Independent monitoring: Medpass Core lab: Cardialysis Statistical analysis: INSERM U970 (Paris) 25 patients enrolled between March 2009 and October 2009 in 5 European clinical sites 25 patients with STENTYS stent IVUS at 0 and 3 days Angiographic and IVUS follow-up at 6 months Post-PCI IVUS image of STENTYS stent in AMI patient IVUS image 3 days after procedure in this patient : 19% increase in reference lumen area Results: IVUS at baseline and 3 days Mean Reference area (distal) (mm²) +19% Mean Stent area (mm²) +18% Mean Lumen area (mm²) +17% Minimum Lumen area (mm²) +19% p<0.02 G. Amoroso et al. EuroIntervention 2011;7:

40 APPOSITION II: Malapposition Eliminated DESIGN: International, prospective, randomized, two-arm multi-center trial OBJECTIVE: Demonstrate superiority of STENTYS over conventional stents in artery apposition in AMI patients ENDPOINTS: Stent strut malapposition at 3 days measured by newest imaging technology (OCT) MACE during hospitalization 30 days and 6 months 80 STEMI patients between 12/09 and 06/10 in 10 European sites STENTYS stent Invasive follow-up at 3 days (QCA, OCT) VISION / DRIVER Clinical follow-up at 30 days and 6 months Patients with severe malapposition at 3 days 30% Stentys 20% 10% p< % Control Balloon Expandable Stent - Day 3 STENTYS Stent - Day 3 0% 0% RJ van Geuns et al. JACC Cardiol. Intv. 2012;5(12):

41 APPOSITION III: low cardiac complication rates at 2 years DESIGN: Prospective, nonrandomized, single-arm, multi-center trial OBJECTIVE: To evaluate the safety and performance of the STENTYS stent in routine clinical practice in large population of STEMI patients ENDPOINTS: MACE at 30 days, 12 and 24 months 1002 patients enrolled in 50 European clinical sites Clinical follow-up at 30 days Clinical follow-up at 1 year Hierarchical MACE 30 days 1 year 2 years Death 1.2% 2.0% 2.3% Re-AMI 1.0% 1.2% 2.0% Clinically driven TLR 1.3% 6.1% 6.9% Total 3.5% 9.3% 11.2% Presented by Maik Grundeken, M.D., from Amsterdam Medical Center at TCT

42 APPOSITION III: Comparative Studies 7% 6% Cardiac Death at 1 Year 5% 4% 3.9% 3% 2% 2.0% 1% 0% Pooled analysis conducted by the ACTION Study group (Prof. G. Montalescot) on 15 studies representing 19,767 patients since

43 Open I DESIGN: Prospective, non-randomized, single-arm, multi-center trial OBJECTIVE: To evaluate the safety and feasibility of the STENTYS DES and BMS in bifurcated lesions ENDPOINTS: Procedural success 30 days and 6 months Events adjudicated by CEC Independent monitoring: Medpass Core lab: Cardialysis 63 patients enrolled between September 2007 and August 2009 in 9 European clinical sites 60 patients with STENTYS stent: 33 patients with STENTYS BMS 27 patients with STENTYS DES Clinical follow-up at 30 days Clinical follow-up at 3 months 3 patients not stented Angiographic and IVUS follow-up at 6 months Results (Number of MACE after 6 months) DES Cardiac Death 0 Q-wave Myocardial Infarction 0 Baseline angiogram Angiogram after treatment of bifurcation lesion 6-month follow-up angiogram Non-Q-wave Myocardial Infarction 0 Clinically driven TLR 1 S. Verheye et al. EuroIntervention 2011;7:

44 Open II DESIGN: Prospective, non-randomized, single-arm, multi-center trial OBJECTIVE: To evaluate the long-term safety and efficacy of the STENTYS PES stent in bifurcation lesions in routine clinical practice. Primary Endpoint: MACE at 6 months Events adjudicated by CEC Independent monitoring: IKKF Principal Investigators: Dr Naber, Prof. Mudra 217 patients enrolled in 21 European clinical sites 208 patients analyzed Clinical follow-up at 6 months Clinical follow-up at 12 months 4 patients outside criteria 5 patients not stented P=0.81 MACE according to balloon technique ( Kissing ) No Final Kissing Final Kissing Results (MACE after 6 months) Cardiac Death 0.5% Emergent CABG 0% Target Vessel MI 4.3% Clinically driven TLR 5.3% Total 10.1% Presented by Dr C. Naber at TCT

45 ADEPT - SVG DESIGN: International, randomized, prospective, multi-center, two-arm clinical study OBJECTIVE: To compare the STENTYS BMS with the STENTYS DES(P) in Saphenous Vein Grafts (SVG). ENDPOINTS: In-stent late lumen loss at six months postprocedure MACE at 30 days and 6 months Independent monitoring and Core Lab: Diagram, Zwolle, The Netherlands 57 SVG patients in 5 EU clinical sites STENTYS BMS QCA at 6 months OCT sub study Clinical FU at 1, 6 and 12 months STENTYS DES(P) Results (MACE after 6 months non hierarchical) Cardiac Death 1.8% Emergent CABG 1.8% Target Vessel MI 3.5% Clinically driven TLR 5.3% Total 10.5% Presented by Dr Ijsselmuiden at EuroPCR