Edwards Lifesciences

Transcription

1 Edwards Lifesciences Heart Valve Therapy Donald E. Bobo Corporate Vice President, Surgical Heart Valves 1

2 Strong Outlook for Surgical Heart Valve Therapy Global patient trends and innovation expected to drive a surgical procedural CAGR of 3%-6% through 2019 Aging global populations Emerging markets Expanding tissue valve segment High-value products Increased confidence in our strategy to extend leadership Elite and improved MIS procedures Long-term evidence for the robustness of the PERIMOUNT design GLX advanced tissue platform Targeting improved options for younger patients 59 The Surgical Business Gained Momentum During EW Underlying Growth Estimate of 3%-5% Product Innovations Launched ; Anticipating CE Mark for Elite Advanced GLX and ZETA Programs Pericardial Portfolio Approved in China Evidence Investments Built Extensive Clinical Data Strengthened Weight of Evidence with 25 Year PERIMOUNT Data Sales & Operations Increased Unit Share*; Held ASPs Completed Singapore Mfg Expansion Responded to FDA Observations in CSS Draper Facility *Based upon internal full-year global estimates. 60 2

3 Going Forward, We Expect Surgical Growth of 3-6% Global Surgical Heart Valve Industry Revenue CAGR Growth Drivers CAGR 3% - 6% Emerging Markets Growth Surgical Pipeline Innovation Headwinds TAVR Substitution Legacy Product Price Pressure <65 + Better Options for Younger Patients Growing Elderly Population ~ Patient and Economic Trends Prioritize Our Strategic Investments Strategic Investment Areas Global Surgical Heart Valve Revenue CAGR Expanding Global Access <65 + Pipeline Innovation CAGR 4% - 6% ZETA GLX EDWARDS INTUITY Elite <65 + Differentiated Evidence Increased TAVI Indications on Surgical Valves Economics ~ Advancing Surgical Innovation Tissue Expansion <65 + into 25-Year Durability Data ViV Registry Younger Patients Growing Elderly Population <65 + Valve Patient Commercial Innovation Access Initiative The Elite valve system, GLX and ZETA are investigational and are not available for commercial sale in the U.S. 62 3

4 Patient-Centric Innovation Drives Adoption Mechanical Valves Porcine Valves Pericardial Valves Advanced Platforms 100% Starr-Edwards CEBP SAV Duraflex PERIMOUNT Magna Magna Ease GLX ZETA Edwards Surgical Valve Sales Mix 0% 1965 ~2020 Patient Benefits Life-Saving Quality of Life Durability Performance MIS Options for Younger Patients The valve system, GLX and ZETA are investigational and are not available for commercial sale in the U.S. 63 Edwards Innovations Target Lifetime of Care Options for Patients Advanced Valve Platforms SAPIEN XT EDWARDS INTUITY Elite Innovating PERIMOUNT Platform Base Pericardial Valves Magna Ease PERIMOUNT + PERIMOUNT Magna Magna Ease GLX Porcine Valves Phasing-Out CEBP SAV Duraflex Porcine The Elite and SAPIEN XT valve systems, GLX and ZETA are investigational and are not available for commercial sale in the U.S. 64 4

5 GLX Advanced Tissue Platform Designed to Offer Performance and Ease-of-Use Benefits Platform Objectives Ultra Durability Improved Anti-Calcification Patient GLX Ease of Use Pre-Packaged Pre-Mounted Physician 10 Years in Development ~300 Patients Treated Efficiencies Glutaraldehyde Eliminated Hospital GLX is investigational and not available for commercial sale in the U.S. 65 GLX Advanced Tissue Platform Enables New Surgical Growth Opportunities GLX Aortic Conduit GLX Magna Ease Conduit Aortic Valve Conduit GLX Magna Ease Conduit Aortic Valve Conduit Launch Timing First Pre-Assembled Tissue Conduit for Aortic Root Surgery Estimated Global Potential of ~$100M Expanded Reach Designed for Younger Patients GLX Younger Older Building Clinical Evidence Animal Study Animal Study Targeted Benefits: Animal Study Extended Durability GLX and ZETA are investigational and are not available for commercial sale in the U.S. Europe ~300 Patients Europe US Improved Long-Term Hemodynamics 66 5

6 ZETA Targeting a Lifetime of Care Option for Patients Built Upon the GLX Advanced Tissue Platform Should Accelerate Mech-to-tissue Conversion Globally Vision is to Broaden Tissue Valve Therapy for Younger Patients Global Patient Age-Wave Goal is to Further Enable VIV Mech Tissue TAVR TAVI Younger Mature Elderly Emerging Markets Developed Regions GLX and ZETA are investigational and are not available for commercial sale in the U.S. Goals Elite For Physicians For Patients For Hospitals Less Invasive, Simplified Procedures Less Trauma, Faster Recovery Shortened LOS, Higher Efficiency The valve system is investigational and not available for commercial sale in the U.S. 68 6

7 Clinical Experience Increases Confidence Clinical Trials Mounting Clinical Evidence ~1,500 Patients Enrollment On-Going TRITON Trial Data 1 Procedural Success Mean Valve Gradient Surgery Duration Respiratory Failure Renal Failure Hospital Length of Stay 97% 8.9 +/- 3.6mmHg High Confidence The valve system is investigational and not available for commercial sale in the U.S. TRITON patient sample of n=~300 (as of December, ). 69 Clinical Experience Increases Confidence Clinical Trials Anticipated Benefits Simplified MIS Reduced Complications ~1,500 Patient Enrollment Improved Procedural Efficiency Differentiated Procedural Outcomes High Confidence 70 7

8 Formal Reimbursement Received in Germany German Reimbursement Reimbursement will increase in January 2014 by ~$4,000 INTUITY clinical evidence established our price range Revised pricing combined with the new DRG should support adoption 15,000 10,000 5,000 Anticipated INTUITY EU Price Range ($US) INTUITY Range Commercial Valve Range 71 Commercialization Update EDWARDS INTUITY Pilot Learn Evidence 2014 Elite Launch Convert Scale Limited Clinical Launch Strong Clinical Interest High Procedural Success Rate Building Clinical Evidence Full Commercial Launch CE Mark Pending Broad Global Launch Favorable Reimbursement (Germany) 72 8

9 Key Milestones and Commercialization Plan Key Milestones Elite CE Mark Trial Enrollment Commercial Registry Enrollment Reimbursement Enrollment Regulatory / Clinical IDE Enrollment Clinical Registry Commercialization Gen I Elite Elite Elite Key Milestones and Anticipated Timing Elite EU Launch TRANSFORM IDE Trial enrollment complete GLX Platform COMMENCE IDE Trial enrollment complete Timing Q2 Q4 Q4 Roll-Out Undertreated Patient Access Initiative Q2 Launch of Minimally Invasive Procedural Enablers ThruPort Knotting System Next-Gen EndoVent with Pacing Next-Gen QuickDraw Cannula Q2 Q4 Q4 The valve system and GLX are investigational and are not available for commercial sale in the U.S. 74 9

10 Edwards Lifesciences Investor Conference 12/9/ Singapore Expansion Complete Significant Increase in Valve Capacity 75 A Growing Surgical Segment Plus Our Investments Should Drive Attractive Growth Global Surgical Industry Outlook Surgical Investments CAGR 3% - 6% Evidence Headwinds Headwinds TAVR Substitution TAVR Substitution Legacy Product Price Pressure Legacy Product Price Pressure INTUITY 2020 ~2019 Pipeline ZETA GLX 76 10

11 Our Investments Should Extend Leadership Global Surgical Industry Outlook CAGR 3% - 6% Extending Edwards Surgical Leadership Competitors Headwinds TAVR Substitution TAVR Substitution Legacy Product Price Pressure Legacy Product Price Pressure ~ Edwards Surgical Valve Leadership Outlook 77 Surgical Sales Growth Outlook Underlying Global Surgical Sales Growth ~2% ~5% 1H 2H* owth Drivers Gro 4% 7% Unit Gains 2014* 2014 Overview Tailwinds Elite Commercialization Advancing New Programs to Address Under-treatment Expanding Tissue Conversion Annualization of Competitive Launch No New Major Competitive Launches Headwinds Hospital Economic Pressures Undisciplined Competitor Pricing Increasing TAVR Activity * 2H and 2014 full-year estimates