Edwards Lifesciences 2008 Investor Conference

Transcription

1 Edwards Lifesciences 2008 Investor Conference Welcome David K. Erickson Vice President, Investor Relations

2 Cautionary Statement Presentations and comments made today by the management of Edwards Lifesciences Corporation will include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of These forward-looking statements include, but are not limited to, the company s ability to achieve 2008 and 2009 financial goals for sales growth, gross profit margin, net income, EPS and free cash flow; the regulatory approval and expected sales of heart valve therapy products including Magna Mitral and Magna Ease; the competitive dynamics of the heart valve market; expected sales and product enhancements for the FloTrac system; the timing, progress and results of clinical studies including the PARTNER trial; the market opportunity for transcatheter valve technologies; and the adoption in Europe and expected 2009 sales of the Edwards SAPIEN valve. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward looking statements are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, Clinician Disclosure The following clinicians are consultants to Edwards Lifesciences and have received compensation from the company Alec Vahanian, M.D. Joseph E. Bavaria, M.D.

3 Opening Remarks Michael A. Mussallem Chairman and CEO Increasing Investments for Future While Delivering High-Teens 2009 Earnings Growth Strong growth for Heart Valve Therapy Two new U.S. valves in 2009 Transcatheter valve procedures double Step-up in gross profit margin Strong earnings per share growth Initiate Glucose growth platform Introduce SAPIEN XT platform

4 Edwards Aspirations Edwards will be recognized as a company that Transforms patient care through innovative technology Excels as a trusted partner and global leader through the quality of our work Attracts and engages talented employees Strengthens our communities Creates exceptional shareholder value Edwards Targets Patient Populations With Important Unmet Clinical Needs Strategy Strategy Results Clinically superior, innovative products Structural t heart disease Critically ill patients A focused portfolio Balances near and long term Delivers strong financial results

5 Edwards is a Global Leader in its Core Businesses Heart Valve Therapy An unmatched product pipeline Driving the transformation of valve treatment Critical Care Technologies A unique global channel Innovating to address unmet needs >90% of sales from products with #1 global positions High barriers to entry and strong brand recognition Global HVT Market* Edwards Other $1.6 billion SRN STJ MDT Global Hemodynamic Monitoring Market* Edwards $475 million HSP Pulsion Other *2008 estimated sales Today s Portfolio is Delivering Growth With the LifeStent divestiture and CardioVations acquisition, Edwards portfolio has become more focused The decision to focus is producing early success Initial THV commercial success Alignment of CSS with Heart Valves is producing results FloTrac is improving Critical Care growth 2008 Revenue Growth* HVT CC CSS Total 0% 5% 10% 15% 20% *Estimated underlying sales growth rates

6 Pursuing Transformational Growth Opportunities in HVT and Critical Care Pre-2008 Sharpened focus on Heart Valve Therapy & Critical Care Driven by SAPIEN, FloTrac & CardioVations Pre-2008 Heart Valve Therapy & Critical Care Adding Glucose, SAPIEN XT & Other THV / SHD SAPIEN, FloTrac & CardioVations Pre-2008 Heart Valve Therapy & Critical Care Edwards is Well Positioned for the Current Economic Climate Products Largely non-discretionary procedures / under-treated population Minimal capital equipment sales Customers Procedures primarily government funded Patient population unaffected by job losses Hospital profitability could slow payments Capital Structure Moving to net cash position Strong operating cash flows Available credit facility at very favorable rates

7 The Current U.S. Legislative and Regulatory Environment is Dynamic Reimbursement Pressure on healthcare spending not having near-term effect Financial crisis may limit funding for new technologies lacking evidence of value Wider healthcare coverage is a positive New leadership Congress, HHS, FDA, etc. Greater transparency of clinician / industry relationships Our Strategy Heart Valve Therapy Increase the growth rate of the surgical heart valve franchise Grow global share in core heart valve therapy Expand surgeon involvement with an integrated MIS / Heart Valve Therapy focus Establish transapical as the surgeon s standard of care for high risk patients Extend leadership with robust product pipeline

8 Our Strategy Transcatheter Heart Valves Extend leadership in transcatheter heart valves Grow transfemoral market share in Europe Make SAPIEN XT the transfemoral standard Successfully complete U.S. PARTNER trial Expand THV therapy beyond Europe Build and defend leading IP portfolio Pursue innovative transcatheter mitral solutions Our Strategy Critical Care Increase Critical Care growth rate through innovation Extend FloTrac adoption and market share Introduce leading Glucose platform Add technologies that are closely aligned

9 Our Strategy Cardiac Surgery Systems Align Cardiac Surgery Systems to complement Heart Valve Therapy Expand MIS options for heart valve therapy Identify additional opportunities that are closely aligned Operations Strengthen infrastructure to support growth Attain operational excellence through best-in-class quality system Enhance reimbursement and clinical research expertise Solid Fundamentals Will Drive Sustainable Financial Performance in Financial Goals Net sales of $1,240 $1,300 million Underlying sales growth of 10 12% Gross profit margin of 68 70% EPS growth of 15 19% Free cash flow of $160 $170 million Excludes special items

10 Key Messages Edwards Lifesciences is a global leader in its core franchises has a focused strategy operates in attractive, growing markets is pursuing exciting new growth opportunities is financially strong Conference Agenda Transcatheter Heart Valve Therapy THV Europe and the U.S. PARTNER Trial Larry Wood An Interventionalist s Perspective Alec Vahanian, M.D. Surgical Heart Valve Therapy Global Market Perspective and Product Pipeline Don Bobo A Surgeon s Perspective Joseph E. Bavaria, M.D.

11 Conference Agenda (cont.) Innovations in Critical Care Carlyn Solomon Glucose Monitoring Expanding Hemodynamic Monitoring Leadership Financial Outlook Tom Abate 2008 Update 2009 Guidance Closing Remarks Mike Mussallem AL Longer Term Perspective Helping Patients is Our Life s Work, and

12 Transcatheter Heart Valve Therapy and the PARTNER Trial Larry L. Wood Corporate Vice President Transcatheter Valve Replacement Transcatheter Aortic Valve Program U.S. PARTNER trial update Global market Reimbursement Next generation technology

13 U.S. PARTNER Trial Update PARTNER U.S. Pivotal Trial Overview Yes OPERABLE ASSESMENT Total n= pts Cohort A Cohort B 350 pts No Femoral Access Evaluation Femoral Access Evaluation Yes No Yes No 1:1 1:1 1:1 Randomization Randomization Randomization 490 pts 200 pts Not in Study No TA in Non- Operable Patients Trans femoral VS AVR Control Trans apical VS AVR Control Trans femoral VS Medical Management Control

14 PARTNER U.S. Pivotal Trial Overview Yes OPERABLE ASSESMENT 690 pts Yes Trans femoral Cohort A Femoral Access Evaluation 1:1 1:1 Randomization 490 pts VS AVR Control Trans apical VS No Randomization 200 pts AVR Control Trial Design Non-Inferiority Primary Endpoint: All Cause Mortality at 1 Year Secondary Femoral Endpoints: Functional improvement Access from baseline MACCE and Evaluation expanded safety composite endpoints Evidence prosthetic valve dysfunction Primary Analysis: All SAPIEN vs. All control Additional Analysis: TF vs. TF Control TA vs. TA Control PARTNER U.S. Pivotal Trial Overview OPERABLE ASSESMENT No Trial Design Superiority Primary Endpoint: All Cause Mortality at 1 Year Secondary Endpoints: Functional improvement from baseline MACCE and expanded safety composite endpoints Evidence prosthetic valve dysfunction Primary Analysis: All SAPIEN vs. All control Yes 1:1 Randomization Trans femoral VS Cohort B Femoral Access Evaluation 350 pts No Not in Study No TA in Non- Operable Patients Medical Management Control

15 Transfemoral Procedural Success is Exceeding Expectations 100% % Success 95% 90% 85% 80% 75% irevive/recast REVIVAL LII REVIVE EII PARTNER EU TF Transfemoral Survival Has Progressively Improved h Freedom from Deat Months past Procedure PARTNER EU (Enrolled 4/07-1/08) RECAST (Enrollment 12/04-5/06) REVIVAL II (Enrolled 12/05-11/06) irevive (Enrollment 8/ ) REVIVE II (Enrolled 1/06-12/07) (Presented at TCT 2008)

16 Transapical is on a Path to Become the Surgeons Standard of Care for High Risk Patients Early transapical results lagged transfemoral results Direct comparisons difficult as TA patients have more co-morbidities Surgeon enthusiasm and EU adoption are strong Patient selection and training have improved outcomes in SOURCE data Similar to transfemoral, new delivery systems and accessories will further improve results Transapical Learning Incorporated in PARTNER Trial Design TA patient selection refined Feasibility trials included non-operable patients Currently not ideal for non-operable patients No TA in Medical Management Arm (Cohort B) of PARTNER trial Procedural improvements are transferrable Visualization and training are critically important Approach not always a direct path to the aortic valve Require sites to gain experience with TF prior to beginning TA

17 PARTNER Trial Enrollment Already Meets Year-End Goal of 600 Patients Enrolled To otal Cumulative # of Patient Q1 Q2 Q3 Q4 Forecast Actual Cohort A / B Timing Adjusted Medical Management Cohort B will complete enrollment in February/March 2009 Surgical Cohort A now expected to complete enrollment in August 2009 The gap between the two cohorts has narrowed Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 PARTNER US Enroll Cohort B Enroll Cohort A - TF and TA 1 Yr Follow Up 1 Yr Follow Up

18 The PARTNER Trial is the Right Design There are still unknowns This is not a well studied patient population Many positives since PARTNER trial launch PARTER EU TF survival data at 6 months is excellent Key TA learnings have been incorporated Global procedural success has been above expectations Overall enrollment is on track Based on everything we know today, remain confident in design The Global Market

19 Key Launch Questions Answered There are many high risk patients 30-60% of patients with severe aortic stenosis go untreated 1,2 Indication is high risk (not just non-operable) The procedure is teachable to a broad base of operators Experienced clinicians adopt techniques quickly World class training and proctoring The procedural success rates are being maintained in a commercial setting Procedural success has been better in the commercial release (~95%) Adequate funding has been available 1 Pellikka, Sarano et al. Outcome of 622 Adults with Asymptomatic, Hemodynamically Significant Aortic Stenosis During Prolonged Follow-Up. Circulation Charlson E et al. Decision-making and outcomes in severe symptomatic aortic stenosis. J Heart Valve Dis2006;15: Commercial Procedural Success Exceeds Expectations Combined TA &TF Procedural Success Rate 100% 98% 96% 94% 92% 90% 88% 86% 84% 82% 80% JAN FEB MAR APR MAY JUN JUL AUG SEPT OCT NOV DEC Procedural success Success Baseline U.S. Feasibility Trial Results Procedural Success Rate is defined as the patient leaves the procedure with the device implanted as expected

20 Transcatheter Valves Increase Aortic Valve Procedures in U.S. and EU Aortic Market Units (U.S. + EU only) 250, ,000 THV Mechanical Tissue CAGR: 6% 150, ,000 Mechanical Tissue CAGR: 2% 50, Transcatheter Valve Opportunity Expected to Exceed $1 Billion ($M) $1,400 Aortic THV Market Revenue (U.S. + EU only) $1,200 $1,000 $800 $600 $400 $200 $

21 Reimbursement Major Country Reimbursement Will Likely Be Formalized in Health technology assessments are in process in all major countries Early feedback from regulators is promising U.K. NICE - Clinical Appraisal: device promising with conditions France: highest rating based on evidence of significant improvement and absence of patient alternatives Expect transitional funding to remain in place

22 THV Reimbursement Status in Major EU Countries Country 1 Country 2 Country 3 Country 4 Country Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Hospital Budget Case by Case Reimbursement Transitional Reimbursement Formal Reimbursement U.S. Reimbursement Local coverage established for PARTNER sites Economic and Quality of Life study underway in parallel with PARTNER clinical study Success will be driven by Positive clinical, economic and quality of life results from PARTNER trial Advocacy by both surgeons and interventional cardiologists

23 Next Generation Technology Number of Competitors Little Significant Competitive Progress Over the Past 12 Months 15 Ventor ValveXchange Sorin Sadra Medtronic JenaValve Heart Leaflet ETR Edwards Direct Flow CoreValve Cordis AorTx AorTech ABPS Players 4 Sadra Edwards Direct Flow CoreValve FIM Performed THV Aortic Market 2 Edwards CoreValve CE Mark Received 1 Edwards IDE

24 Number of Competitors Little Significant Competitive Progress Over the Past 12 Months 15 Ventor ValveXchange Sorin Sadra Medtronic JenaValve Heart Leaflet ETR Edwards 5 Direct Flow CoreValve Ventor Cordis AorTx AorTech ABPS Players Sadra Edwards Direct Flow CoreValve FIM Performed THV Aortic Market 2 Edwards CoreValve CE Mark Received Edwards IDE Number of Competitors Little Significant Competitive Progress Over the Past 12 Months THV Aortic Market 15 Ventor ValveXchange Edwards Edwards Edwards Sorin First in Man Feasibility IDE Pivotal IDE Sadra Medtronic JenaValve Heart Leaflet ETR Edwards Direct Flow 5 CoreValve Ventor Cordis AorTx AorTech ABPS Players Sadra Edwards Direct Flow CoreValve FIM Performed 2 Edwards CoreValve CE Mark Received 1 Edwards IDE

25 THV Device Design is Evolving Rapidly Untreated Equine Tissue Bovine Pericardial Tissue ThermaFix anti-calcification process Leaflets matched for both deflection Cobalt-Chromium Frame Bovine Pericardial Tissue ThermaFix anti-calcification process Leaflets matched for both deflection Cribier-Edwards THV Edwards SAPIEN THV 23 and 26mm Edwards SAPIEN XT THV 20, 23, 26 and 29mm THV Delivery is Rapidly Improving Reduced Profile SAPIEN with RF1 SAPIEN with RF2 SAPIEN with RF3 SAPIEN XT with RF4

26 SAPIEN XT Most Advanced THV System Achieve 4-5Fr profile reduction without compromising key valve fundamentals Increased frame strength Expect improved durability from SAPIEN XT SAPIEN XT leverages all of our knowledge and experience from SAPIEN ThermaFix Magna-type design features Implantation technique remains similar SAPIEN XT to Begin European Trial in Fourth Quarter 2008 Start CE Mark trial in Europe in Q Historically, approximately 100 patients followed for 6 months was sufficient Estimate CE Mark approval in first half of Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 PREVAIL EU EU Trial Enrollment Follow Up CE Mark First patient in trial implanted successfully yesterday

27 SAPIEN XT U.S. Trial Plans Targeting Q4 09 to begin U.S. trial Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 PARTNER US Enroll Cohort B Enroll Cohort A - TF and TA 1 Yr Follow Up 1 Yr Follow Up Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 SAPIEN XT SAPIEN XT IDE Trial and 1 Yr Follow Up Pulmonic Opportunity Leverages Aortic Platform Currently in U.S. IDE feasibility study with 3 centers Expect to complete enrollment in first 30 patient feasibility by April 2009 Transition to HDE trial and expect to complete enrollment by year end While this is a relatively small opportunity, it requires only a modest investment

28 Continue to Strengthen and Expand Our THV Intellectual Property European infringement lawsuits proceeding against CoreValve; U.S. trial in 2010 U.S. Andersen claims should be strengthened by our continuation efforts Cribier-Letac portfolio progress One U.S. patent issued Several U.S. and EU patents pending Developing other strong internal THV intellectual property 2009 Key Milestones Continue to drive technology adoption Edwards focus has and will continue to be on clinical success Continue international expansion Goal to double the number of procedures in revenue assumption of $75 - $95 million PARTNER Trial Cohort B enrollment complete in Feb./Mar Cohort A enrollment complete by Aug SAPIEN XT Complete CE Mark trial enrollment by Q2 09 Gain U.S. IDE approval by year-end 2009

29 Helping Patients is Our Life s Work, and Transcatheter Aortic Valve Implantation Alec Vahanian, FESC, FRCP (Edin.) Bichat Hospital, Paris, France Pr Alec Vahanian, FESC, FRCP (Edin.) Bichat Hospital, Paris, France

30 Transcatheter Aortic Valve Implantation Scope of the Problem European Heart Journal (2003) 24(13), doi: /eurheartj/ehl183 Euro Heart Survey A prospective survey of patients with valvular European Heart Journal (2007) 28, heart disease doi: /eurheartj/ehl428 in Europe: the Euro Heart Survey on Valvular Disease Guidelines on the management of valvular l heart disease Bernard Iung, Gabriel Baron, Eric G. Butchart, François Delahaye, Christa Gohlke-Baerwolf Baerwolf, Olaf W. Levange, Pilar Tornos, Jean-Louis Vanoverschelde, Frank Vermeer, Eric Boersma, Philippe Ravaud, and Alec Vahanian Eur Heart The J 2003;24(13): Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology ESC Guidelines Authors/Task Force Members, Alec Vahanian (Chairperson), Paris (France), Helmut Baumgartner, Vienna (Austria), Jeroen Bax, Leiden (The Netherlands), Eric Butchart, Cardiff (UK), Robert Dion, Leiden (The Netherlands), Gerasimos Filippatos, Athens (Greece), Frank Flachskampf, Erlangen Germany), Roger Hall, Norwich (UK), Bernard Iung, Paris (France), Jaroslaw Kasprzak, Lodz (Poland), Patrick Nataf, Paris Percutaneous (France), and Pilar Minimally Tornos, Barcelona Invasive Valve (Spain), Procedures: Lucia Torracca, a Scientific MilanStatement from the (Italy), Arnold Wenink, Leiden American (The Heart Netherlands) Association Council on Cardiovascular Surgery and Anesthesia, Council on Ci Clinical i Cardiology, Functional Genomics and Translational Biology Interdisciplinary i i Eur Heart J 2007;28: Working Group, and Quality of Care and Outcomes Research Interdisciplinary Working Group. Todd K. Rosengart, Ted Feldman, Michael A. Borger, Thomas A. Vassiliades Jr., Marc Gillinov, Katherine J Hoercher, Alec Vahanian, Robert Bonow and William O Neill. Circulation 2008;117; ; originally published online Mar 10, 2008 DOI: /CIRCULATIONAHA Circulation is published by the American Heart Association Greenville Avenue, Dallas, TX, Copyright 2008 American Heart Association. All rights reserved. Print ISSN: Online

31 Prevalence and Impact of Heart Valve Diseases < Age (years) (Nkomo et al. Lancet 2006;368: ) Northern 400 Western 1407 Eastern 1750 Mediterranean 1444 (Iung et al. Eur Heart J 2003;24: )

32 Age in Native VHD 3547 Patients with Native Valve Disease n= (Iung et al. Eur Heart J 2003;24: ) Male The Graying of the World Population by Age, Sex 2030 Age Baby boom Population in millions Female

33 Burden of Valve Diseases in the US Year Disease AS millions millions Natural History of Aortic Stenosis Survival Percent Latent Period (Increasing Obstruction, Myocardial Overload) Onset severe symptoms Angina Syncope Failure Avg. survival Years Age Years

34 > 65 yrs in EU 77 M Prevalence AoS 4% Number 3 M AVR 20% Potential Pool Annual AVR ~ !!!!!

35 Conclusion Surgery was denied in 33% of elderly patients with severe, symptomatic AS. Older age and LV dysfunction were the most striking characteristics of patients who were denied surgery, comorbidity played a less important role. whereas Synthesis of Edwards SAPIEN TAVI Experience Pr Alec Vahanian, FESC, FRCP (Edin.) Bichat Hospital, Paris, France

36 Management of Patients The Team Approach SURGEON CARDIOLOGIST Anesthesiologist Transcatheter Aortic Valve Implantation Imaging specialists (Echo, CT, MRI) Engineer

37 Inclusion Criteria for TAVI After assessment by the Team Severe AS Symptomatic Life expectancy >1year Contra indication for surgery,or High Risk for Surgery : Clinical judgement + EuroScore (logistic) > 20%;STS Score>10% AND/OR Porcelain aorta History of thoracic irradiation Severe thoracic deformity Patent coronary by pass Where Should We Perform? The Ideal Setting Hybrid Room

38 SOURCE REGISTRY Update on 30Day follow-up The SOURCE Registry Post CE Mark multicenter, observational collection of early procedural success and long term follow-up to evaluate, the transition to commercial clinical use under controlled market release conditions with a prescribed training i and proctor program Clinical update as per November 2008 Source Database 34 Contributing sites in Europe 418 patients with complete 30 days clinical follow-up BASELINE DEMOGRAPHIC DATA TF TA All AGE (yrs) 81.9± ± ±7.0 GENDER (female%) 56.6% 53.4% 55.1% EUROSCORE (%) 26.3± ± ±15.5

39 PROCEDURAL SUCCESS SOURCE Registry- Procedural/30 Day Survival

40 SOURCE Registry Functional Improvement by NYHA At 30 days 87% of the patients are in NYHA Class I or II Clinical Results Feasibility Trials

41 1 Year Transfemoral Survival REVIVE II,REVIVAL II (n = 161) Transcatheter Aortic Valve Implantation Coronary Obstruction Rouen = 0 Vancouver = 0.5% Revive/revival = 0.5%

42 Aortic Regurgitation Following TAVI AR Following 23mm Valve Implantation AR Following 26mm Valve Implantation 7.5% 15.0% 36.1% 13.1% 32.5% 33% 45.0% 50.8% REVIVE II & REVIVAL II NYHA Class 12 months n = 32 n = 18 n = 6 n = 7 n = 1 89% had at least one class 12 months

43 REVIVAL II Kansas City Cardiomyopathy Questionnaire Results * p <.001 vs. baseline Percutaneous Aortic Valve Implantation Long-Term Results p=0.15 p=0.88 P< (Webb. Circulation 2007;116: )

44 Management of AS in the TAVI Era 115 Pts with EuroSCORE 20% - STS PROM 10% or CI to Surgery TF TAVI 35 (30%) CI to TF TAVI 80 (70%) Symptomatic Rx 46 (40%) TA TAVI 15 (13%) Conventional AVR 19 (17%) (D.Himbert, ESC 2008) Conclusions Need for better education on this important public health problem TAVI requires a close collaboration between interventionists, echocardiographists, engineers, surgeons, and other specialists Patient t selection should be performed by the team assessing the need for intervention,the risk/benefit ratio of intervention,and the feasibility of TAVI The first steps of TAVI show that these new techniques are feasible and provide improvement in hemodynamics and clinical condition at mid term The clinical results improved over time due to better patient selection and management of the procedure The availability of two approaches increases the number of patients who may receive intervention

45 We are still learning a lot, but I can see a great potential Andreas Gruntzig