Edwards Lifesciences 2011 Investor Conference 12/9/2011

Transcription

1 Edwards Lifesciences 2011 Investor Conference EDWARDS LIFESCIENCES Transcatheter Heart Valves Larry L. Wood Corporate Vice President, Transcatheter Valve Replacement 2 1

2 Edwards Lifesciences 2011 Investor Conference Executive Summary Global transcatheter heart valve opportunity continues to be strong and growing Edwards' procedures grew more than 50% in 2011 Expect to add high-risk patients to the U.S. launch in 2012 motivates untreated patients to explore therapy options Edwards extended leadership in 2011 Edwards SAPIEN launched for inoperable patients in the U.S. The PARTNER Trial Cohort A U.S. IDE data published in NEJM The PARTNER II Trial U.S. IDE approved for moderate risk Edwards will continue to aggressively invest Initiate CE Mark trials on two new valve platforms in 2012 Plan a regular cadence of advancing technology Estimated Underlying Sales Growth of 70% - 90% in The PARTNER Trial, Cohort B Confirms Severe, Symptomatic AS has a Dismal Natural Course Post Mortem Study, 1968 Ross and Braunwald. Circulation, Randomized Controlled Trial, 2010 The PARTNER Trial, Cohort B Valvular Aortic Stenosis in Adults Average Course (Post Mortem Data) The PARTNER Trial, Cohort B ITT PMA Control Patients* Survival 100 % survival Months Post Randomization With severe symptomatic AS, survival without intervention is 2-5 years Actual survival for patients with severe, symptomatic AS without intervention was ~25% at 3 yrs *Crossover patients censored at crossover 4 2

3 Edwards Lifesciences 2011 Investor Conference Approximately a Quarter of a Million Americans Have Severe, Symptomatic AS Moderate and Severe Aortic Stenosis (1) (AS) ~1.5 M Severe AS (1) ~500,000 Severe AS, Symptomatic (2) ~250,000 ~1/3 rd Severe ~1/2 Symptomatic (1) Nkomo 2006, Iivanainen 1996, Aronow 1991, Bach 2007 (2) Internal estimates, Freed 2010, Iung 2007, Pellikka The Majority of These Patients Do Not Receive Life-saving Aortic Valve Replacement (AVR) Moderate and Severe Aortic Stenosis (1) (AS) ~1.5 M Severe AS (1) ~500,000 Severe AS, Symptomatic (2) ~250,000 ~1/3 rd Severe ~1/2 Symptomatic Currently Untreated Indicated for surgery (3) SAVR (1) Nkomo 2006, Iivanainen 1996, Aronow 1991, Bach 2007 (2) Internal estimates, Freed 2010, Iung 2007, Pellikka 2005 (3) Bonow

4 Edwards Lifesciences 2011 Investor Conference Edwards Believes Will Motivate Untreated Patients to Explore Options U.S. Severe, Symptomatic AS (~ , Patients) Currently Untreated Indicated for surgery (1) SAVR These untreated patients do not receive intervention for reasons which could include: Too sick to benefit from AVR High risk or inoperable Patient refusal Not currently managed by a cardiologist Undiagnosed With, untreated patients are more likely to be evaluated for therapy (1) Bonow The Introduction of Stimulated Procedure Growth in Europe E.U. AVR Units (SAVR & ) SAVR (E) AVR CAGR % AVR CAGR (E) 6.3% Source: Internal Estimates 8 4

5 Edwards Lifesciences 2011 Investor Conference Edwards AVR Growth Has Been Lifted Even Further with EDWARDS Edwards E.U. AVR Units (SAVR & ) SAVR (E) AVR CAGR % AVR CAGR (E) 2011(E) 13.3% Source: Internal Estimates 9 Formal Reimbursement for in Europe is Expected to Expand Spain Greece Belgium Finland Norway Switzerland United Kingdom Italy Austria The Netherlands Sweden Denmark France Germany Reimbursement in 2011 Spain Greece Belgium United Kingdom Italy Finland Norway Switzerland Austria The Netherlands Sweden Denmark France Germany Reimbursement in 2012 Formal Reimbursement Temporary and/or Case by Case Reimbursement Hospital Budget 10 5

6 Edwards Lifesciences 2011 Investor Conference We Believe Edwards Maintains Leadership Even With Increased Competition Estimated OUS Units* Startup Strategics Edwards *Excludes Japan 11 The SAPIEN Valve Was Approved in the United States on November 2, 2011 INDICATION Transfemoral delivery in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis 12 6

7 Edwards Lifesciences 2011 Investor Conference Edwards is Planning Rigorous Post Approval Studies Two Post Approval Studies (PAS) Planned PAS 1: Continued Follow-Up of Premarket Cohort Follow all patients from The PARTNER Trial and continued access (total ~3,100) Objectives are to describe: - Valve durability at five years - Patient Quality of Life (QOL) outcomes at five years Annual assessment for five years PAS 2: Newly Enrolled Study Follow newly enrolled patients (minimum ~1,100) Objectives are to evaluate: - Learning curve at 50 + sites - Safety and effectiveness - Complications Assessment at 30 days and annually for 5 years Edwards to collect data and report to FDA Ultimately recorded into a national registry 13 Edwards Believes That a Well-Written Written NCD Should Include: Indication Facility Requirements Training Program Inoperable and high risk patients Future indications as they are FDA approved IDE or other qualifying clinical study Multidisciplinary heart team Modified cath lab and operating room or hybrid OR Volume restrictions should be reasonable, as these are not a consistent predictor of quality outcomes* Edwards-provided comprehensive training program Credentialing responsibility retained by hospitals Data Collection All patients enrolled in a audited registry or clinical trial Coverage with Evidence Development for other indications *Khumbhani 2009, Epstein 2004, Garg 2011, Plomondon

8 Edwards Lifesciences 2011 Investor Conference Formalized U.S. Reimbursement is Moving Quickly CMS Timeline Oct Nov Dec Jan Feb Mar Apr May Jun Jul NCD Assessment Begins CMS Issues Proposed NCD CMS Issues Final NCD 30 day Public Comment Period 30 day Public Comment Period In October 2011, new ICD Codes were aligned to the DRGs for surgical AVR, setting the payment rate. A well-written written National Coverage Determination (NCD) would be positive for patients and physicians by insuring uniform coverage nationally 15 First Twelve Months of U.S. Launch Estimated at $150M - $250M $500 Edwards U.S. THV Cumulative Revenue Cumulative Sales (USD, $K K) $250 Cohort A Approval High Risk Patients $0 November Launch Inoperable Patients 0 Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Months After Launch 12 months 2012 U.S. sales estimated at $200M - $260M 16 8

9 Edwards Lifesciences 2011 Investor Conference Edwards is On Track for $20-$25 $25 Million of Sales in the First Three Months Guiding Principle As always, our guiding principle is to ensure excellent clinical outcomes for patients Site A focus on capability and partnership secure a Selection successful heart team on day one and long term Sites demonstrate commitment to a program through an initial stocking order of 8 units Disciplined Training Edwards robust program includes: Didactic session Case observation Simulations Proctoring Clinical specialists will support initial cases Sites with proven volume and procedural success will become eligible for consignment 17 Procedures are Expected to Ramp Steadily as the Launch Progresses Conceptual U.S. Growth by Quarter Procedures 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q

10 Edwards Lifesciences 2011 Investor Conference Reported Sales are Impacted by Stocking and Consignment Cadence Conceptual U.S. Growth by Quarter Reported Sales Procedures 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q Stocking orders boost sales in early launch 19 Reported Sales are Impacted by Stocking and Consignment Cadence Conceptual U.S. Growth by Quarter Reported Sales Procedures 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q Reported sales appear flat in mid-launch due to consignment effect 20 10

11 Edwards Lifesciences 2011 Investor Conference Reported Sales are Impacted by Stocking and Consignment Cadence Conceptual U.S. Growth by Quarter Reported Sales Procedures 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q Reported sales approximate procedure growth in mid Review of The PARTNER Trial PMA Timing The PARTNER Trial, Cohort B PMA Approved 1 Year Follow-Up Complete Q2 November 2, 2011! FDA Submission FDA Panel Q4 Q3 1 year from submission to approval (FDA average is ~550 days) PMA Approval Q4 The PARTNER Trial, Cohort A 1 Year Follow-Up Complete Q4 FDA Submission FDA Panel* PMA Approval* Q2 Q1 Assuming 1 year from submission to approval (FDA average is ~550 days) Q2 *FDA panel has not been scheduled for The PARTNER Trial, Cohort A. Panel and PMA approval timing are Edwards estimates

12 Edwards Lifesciences 2011 Investor Conference The PARTNER II Trial is Approved Symptomatic Severe Aortic Stenosis ASSESSMENT: Operability n~2,000 Operable STS > 4 Total ~ 2,600 patients 2 Parallel Trials: Individually Powered Inoperable n>600 ASSESSMENT: Access ASSESSMENT: Transfemoral Access Transfemoral Transapical 1:1 Randomization 1:1 Randomization 1:1 Randomization Nested Registry Trans AVR Trans AVR femoral SAPIEN apical SAPIEN XT VS VS VS Primary Endpoint: All Cause Mortality and Primary Endpoint: All Cause Mortality and Major Stroke Major Stroke 2 year follow-up 1 year follow-up 23 The PARTNER II Trial, Cohort B Enrollment Continues, Expected Completion January 2012 Symptomatic Severe Aortic Stenosis ASSESSMENT: Operability The PARTNER II Trial, Cohort B Inoperable n>600 Enrollment completion expected January 2012 ASSESSMENT: Transfemoral Access Nested 1:1 Randomization Registry SAPIEN SAPIEN XT VS Primary Endpoint: All Cause Mortality and Major Stroke 1 year follow-up 12

13 Edwards Lifesciences 2011 Investor Conference The PARTNER II Trial, Cohort A was Approved for Moderate Risk Patients on November 7, 2011 Symptomatic Severe Aortic Stenosis ASSESSMENT: Operability Operable n~2,000 STS > 4 ASSESSMENT: Access Transfemoral Transapical 1:1 Randomization 1:1 Randomization The PARTNER II Trial, Cohort A: Trial Design Includes severe, symptomatic moderate risk patients 1:1 randomization against surgery 2 year follow-up Trans femoral VS AVR Trans apical VS AVR Primary Endpoint: All Cause Mortality and Major Stroke 2 year follow-up PARTNER II Cohort A Targets an Expanded Indication ts* % of All Isolated SAVR Patient 30% 25% 20% 15% 10% 5% 0% STS Risk Score for Isolated SAVRs in the U.S. The PARTNER II Trial, Cohort A STS Score ~40% of Total The PARTNER Trial <10% of Total >10 STS National Adult Cardiac Database, 2005 Harvest. Isolated SAVR. 13

14 Edwards Lifesciences 2011 Investor Conference Estimated U.S. Approval for SAPIEN and SAPIEN XT PARTNER Cohort B SAPIEN FDA Review (367 days) Approved PARTNER Cohort A SAPIEN EW Assumed FDA Review 1 Average FDA Review 2 PARTNER II SAPIEN XT Cohort B: NovaFlex+ Only Enroll Patients Cohort A: NovaFlex+ & Ascendra+ 1 Yr Follow Up & File PMA Enroll Patients EW Assumed FDA Review 1 Average FDA Review 2 2 Yr File Follow Up PMA EW Assumed FDA Review 1 Average FDA Review 2 1 Edwards assumes a 12 month or 365 day review/approval time 2 FDA review/approval time averaging over 550 days over past two years 27 Edwards Has a Multi-Faceted Approach to Address Stroke Opportunities to reduce stroke Lower profile delivery systems and device enhancements Patient selection Procedure enhancements The PARTNER II Trial evaluates stroke Protocolized anti-coagulation and anti-platelet regimen Specific pre- and post-operative neurological assessments Standardized Rankin questionnaire In Europe, the PROTAVI trial will study the causes of stroke and evaluate Embrella Evaluate where and when neurological events occur Data could be used to support a U.S. 510(k) clearance Planned initiation Q

15 Edwards Lifesciences 2011 Investor Conference In the U.S., the SAPIEN Platform is Commercial While the SAPIEN XT Platform is in IDE Trial Commercial Device* IDE Trial Enrolling SAPIEN THV SAPIEN XT THV* Provides predictable and precise valve deployment Lower profile, improved delivery and valve design * The Edwards SAPIEN XT valve and the Edwards SAPIEN valve with the Ascendra delivery system are investigational devices and are not available for commercial sale in the U.S. 29 The OUS Offering Features SAPIEN XT, Available in Four Sizes OUS Commercial Offering SAPIEN XT THV* Transfemoral Approach NovaFlex+ with esheath Sizes Available 29mm* 26mm 23mm 20mm* Annulus Size (mm) Japan EU Transapical and Transaortic * Approach Ascendra+* * The Edwards SAPIEN XT valve and the Edwards SAPIEN valve with the Ascendra delivery system are investigational devices and are not available for commercial sale in the U.S

16 Edwards Lifesciences 2011 Investor Conference Building on a Solid Foundation Commercial Device* SAPIEN THV IDE Trial Enrolling SAPIEN XT THV OUS O.U.S. Commercial Offering SAPIEN XT THV U.S. Offering OUS Offering * The Edwards SAPIEN XT valve and the Edwards SAPIEN valve with the Ascendra delivery system are investigational devices and are not available for commercial sale in the U.S. 31 Expect CE Mark Trials on Two New Valve Platforms in 2012 Balloon Expandable Self Expanding Commercial Device* SAPIEN THV IDE Trial Enrolling SAPIEN XT THV OUS O.U.S. Commercial Offering SAPIEN XT THV U.S. Offering OUS Offering * The Edwards SAPIEN XT valve, the Edwards SAPIEN valve with the Ascendra delivery system, the Edwards SAPIEN 3 valve and the Edwards CENTERA valve are investigational devices and are not available for commercial sale in the U.S

17 Edwards Lifesciences 2011 Investor Conference SAPIEN 3 Advances Best-in-Class Design Edwards SAPIEN 3 Valve Ultra Low-Profile Balloon Expandable Platform Designed to further reduce PV leaks Lower profile valve delivered through a 14 Fr esheath Discrete valve that anchors in the annulus Treated bovine pericardial tissue leaflets Dramatically reduced profile for the transapical approach The Edwards SAPIEN 3 System is not available for commercial sale in the U.S. 33 CENTERA is Edwards First Self- Expanding Transcatheter Valve Edwards CENTERA Valve Ultra Low-Profile Self Expanding Platform Motorized delivery system for stable deployment and single operator use Repositionable Delivered through a 14 Fr esheath Discrete valve that anchors in the annulus Treated bovine pericardial tissue leaflets Transfemoral and subclavian approach First-in-Man Experience Completed The Edwards CENTERA Valve System is not available for commercial sale in the U.S

18 Edwards Lifesciences 2011 Investor Conference U.S. THV Litigation Provides 2012 Potential Upside Edwards v. CoreValve appeal decision expected in mid 2012 Federal jury found that Edwards U.S. Andersen transcatheter heart valve patent is valid and Medtronic CoreValve LLC willfully infringes it Both sides appealed Substantial potential damages, future royalties or injunction $74M assessed on 4/1/2010 New THV lawsuits in California initiated in 2011 by both Edwards and Medtronic Outlook Sales outlook of $560-$630 million Includes $200-$260 million of U.S. sales Expected OUS product launches Ascendra+ for SAPIEN XT with a TAo indication mid-2012 NovaFlex+ for 29mm SAPIEN XT mid-2012 PARTNER Cohort A Expect FDA panel meeting in Q Expect approval mid-2012 Japan clinical filing 1H 2012 PARTNER II Complete enrollment in Cohort B January 2012 Begin CE Mark trial in 2012 SAPIEN 3 CENTERA 36 18

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