NASDAQ: ELGX December Innovation that Empowers

Transcription

1 NASDAQ: ELGX December 2014 Innovation that Empowers

2 Safe Harbor This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, statements relating to the growth of the EVAR market and Endologix s participation therein, Endologix guidance on revenue, financial results, cash use and growth, Endologix successfully developing, obtaining approval and marketing and selling its products under development, regulatory processes and timelines, growing its direct sales force in the US and Europe, training of physicians, and progress and completion of clinical trials. Endologix intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Exchange Act and the Private Securities Litigation Reform Act of These statements are based on the current estimates and assumptions of Endologix's management as of the date of this presentation and are subject to risks, uncertainties, changes in circumstances and other factors that may cause actual results to differ materially from the forward-looking statements made in this press release. Important factors that could cause actual results to differ materially from forward-looking statements include, but are not limited to, the ability of Endologix to timely and successfully complete clinical trials and to obtain and maintain required U.S. Food and Drug Administration and other regulatory approvals of its products, the scope and validity of intellectual property rights applicable to its technology, the ability to recruit and maintain sales personnel in Europe, competition from others, changes in reimbursement policies, unexpected litigation expenses, and additional factors that may affect future results which are detailed in Endologix's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 3, 2014 and in Endologix's other periodic reports filed with the Securities and Exchange Commission. Endologix undertakes no obligation to revise or update information herein to reflect events or circumstances in the future except as may be required by law, even if new information becomes available. 2

3 ELGX Investment Highlights Large Market Opportunity $1.6 billion worldwide market Market potential $3.3 billion Growth Drivers Innovative new product pipeline Sales force expansions Positive clinical evidence Attractive Financial Profile Double digit sales growth Gross margins > 70% ~$101M in cash at Sept 30,

4 Abdominal Aortic Aneurysm (AAA) Affects 5-6% of the population over the age of 65 (mostly men) Approximately 170,000* worldwide procedures in 2013 Reimbursement and screening programs in place Endovascular Repair EVAR Open Surgical Repair VS Minimally invasive catheter based therapy Short procedure times 1-2 day hospital length of stay Includes EVAR and Open Surgical Repair. Market size based on Company estimates Extremely invasive High mortality and morbidity Long operating and recovery times

5 AAA Market Segments by Patient Anatomy Complex AAA Market 36% <10mm 64% 10mm Traditional AAA Market Diagnosed AAAs by Aortic Neck Length (Distance from the lowest renal to top of Aneurysm) Karthikesalingam A, et al. Eur J Vasc Endovasc Surg (e-published Aug 1) 5

6 2015 EVAR Market = $1.6B Complex AAA Market 29% Penetration 8% CAGR $363M $1,250M Traditional AAA Market 75% Penetration 4% CAGR Global Market <60% Penetrated *Market Size, Penetration and CAGR Based on Company Estimates 6

7 Complex AAA Market Represents Significant Growth Opportunity EVAR + Snorkels $72M 5% FEVAR $152M 9% EVAR Off-Label $139M 15% 71% Unpenetrated $1,245M Potential Current Complex Market <30% Penetrated *Market Size and Penetration Based on Company Estimates 7

8 $3.3B AAA Market Opportunity Complex AAA Market Traditional AAA Market $1.6B $1.7B Significant Growth Potential in Both Traditional and Complex Market Segments *Market Size and Penetration Based on Company Estimates 8

9 Competition EVAR EVAS Crowded Market Similar Products AFX is only Device that Preserves the Bifurcation Only Technology that Seals the Entire AAA 9

10 Endologix EVAR System Anatomic Fixation Preserves the Bifurcation No Gate Cannulation Profile = 17F & 9F Sheaths Next Gen AFX Planned for 2H

11 Endoleak Rate Endoleak Rate AFX Clinical Evidence Type IA Endoleaks Hostile Necks Type II Endoleaks 12% 10% 11% 40% 34% 34% 8% 7% 7% 30% 6% 4% 4% 20% 17% 2% 10% 5.5% AFX AFX Low Rate of Endoleaks 1. AbuRhama et al, J Vasc Surg 2011; 54: year 2. Stather et al. Endovascular Aortic Aneurysm Repair in Patients with Hostile Neck Anatomy. JVS 2013;20: >30 days 3. Torsello et al, J Vasc Surg 2011; 54: year AFX: Independent Core Lab Evaluation by Syntactx, R. Motaganhalli et al, Midwestern Vascular G. Torsello et al, J Vasc Surg epub 2014 Cordis Incraft Innovation Trial, 1-y results 2 Ovation Prime IFU 3 E. Cieri et al, J Vasc Surg 2014; 59: year AFX Arthurs et al. Endograft Apposition at the Proximal Aortic Neck Predicts Aneurysm Sac Regression. Presented at the Western Vascular 2014 Annual Meeting. September, 2014

12 The 1 st ever prospective, randomized, multicenter study comparing AFX to other commercially available EVAR devices 800 patients in 80 U.S. centers Each center randomizes AFX to one other EVAR device Primary Endpoint is treatment success at 1 year and freedom from MAEs, endoleaks and secondary interventions Enrollment expected to begin Q

13 The 1 st and Only Device that Seals the Entire Aneurysm (EVAS) Designed to reduce endoleaks and secondary interventions Broad Anatomical Applicability Simple, Predictable Procedure IDE Enrollment Completed 179 patients, 30 centers Continued Access Planned for 2015 Expect PMA approval late 2016 CE marked

14 Clinical Evidence YR FU N=300 2 YR FU N=300 3 YR FU N=300 4 YR FU N=300 PHASE 2 Enroll N=200 1 YR FU N=200 2 YR FU N=200 1 YR FU N=180 2 YR FU N=180 3 YR FU N=180 4 YR FU N=180 CONTINUED ACCESS Enroll N=200 1 YR FU N=200 2 YR FU N=200 3 YR FU N=300 Cumulative Nellix Patients 0-1 YR FU N= YR FU N= YR FU N= YR FU N=880 Enroll Clinical Study N=800 1 YR FU N=800 2 YR FU N=800 14

15 EVAS Global Registry Includes Much More Complex AAAs than Other Studies 20% 17.0% EVAS Global Registry 15% ENGAGE Registry GREAT Registry 10% 5% 0% 2.2% 1.5% Neck Length <10mm 9.0% 6.0% Neck Angle >60 0.0% 5.7% 3.5% 2.5% 0.5% 0.1% 0.0% Chimney Procedure Rupture or EVAR Repair 15

16 Overall Endoleak Rates at 6 months 45.0% 40.0% 40% 42% 35.0% 30.0% 25.0% 20.0% 15.0% 10.0% 9% 12% 13% 14% 17% 20% 5.0% 1% 0.0% Nellix Registry Zenith IDE Endurant IDE Powerlink IDE Talent IDE Type IA, IB Type II Type III/IV Undetermined Aorfix IDE Excluder IDE Incraft CE Study Ovation IDE EVAS Forward Global Registry: Mean follow-up 6 months 1-year results shown for Aorfix and Incraft (6 month data not reported) 16

17 Complex AAAs: EVAS Approaches Nellix w/snorkels* Paravisceral System* Alternative to FEVAR and potential to treat more patients Endobag and polymer sealing around branch stents More clinical work planned in 2015 Design still in development and testing Targeting 4 branch capability Clinical work planned in *Potential concepts shown. Neither approach is currently approved for clinical or commercial use.

18 ELGX Product Portfolio Complex AAA Market Traditional AAA Market Paravisceral 36% <10mm 64% 10mm Nellix AFX Solutions for all AAA Patients 18 18

19 Global Sales Force Over 450 years of EVAR experience Highly trained aortic specialists Provide direct clinical support U.S. 93 sales reps & clinical specialists growing to ~100 by end of 2014 ; 18% growth in 2014 Europe 28 sales reps & clinical specialists growing to ~32 by end of 2014; 28% growth in 2014 Other International Markets Distributors in Japan & Latin America 19

20 2015 Growth Initiatives NORTH AMERICA AFX Clinical Data Nellix CAP AFX3 Launch PEVAR LEOPARD Sales Force Expansion LATIN AMERICA Limited Nellix Introduction VELA Launch EUROPE Nellix Launch VELA Launch Sales Force Expansion ASIA PACIFIC AFX Launch in Japan Limited Nellix Introduction 20

21 ELGX Investment Highlights Large Market Opportunity $1.6 billion worldwide market Market potential $3.3 billion Growth Drivers Innovative new product pipeline Sales force expansions Positive clinical evidence Attractive Financial Profile Double digit sales growth Gross margins > 70% ~$101M in cash at Sept 30,