Donald E. Bobo, Jr. Corporate Vice President, Heart Valve Therapy. Surgical Heart Valve Therapy

Transcription

1 Surgical Heart Valve Therapy Donald E. Bobo, Jr. Corporate Vice President, Heart Valve Therapy Celebrating 50 Years of Partnership - Leading 4 Generations of Heart Valve Innovation Mechanical Era Starr-Edwards Porcine Era Carpentier-Edwards Pericardial Bioengineered Era Carpentier-Edwards Pericardial MAGNA Minimally Invasive Era SAPIEN Classic Degenerative MR Physio Tricuspid Classic Tricuspid Functional MR GeoForm

2 Global Heart Valve Therapy Executive Summary Market leading portfolio of tissue and repair products Global heart valve opportunity remains attractive Global conversion from tissue to mechanical Significant opportunity for market expansion Edwards is leading the evolution of this market Expanding market with MIS and transcatheter valves Leading investments in new therapy platforms Edwards is partnering with physicians for the future Advancing procedure training and education initiatives CoreValve ATS Market is Sizeable and Growing Faster - Edwards is the Global Leader SRN MDT Total HVT ~$1.6B 13% Growth Other 2008E Global Total HVT Market Edwards SRN MDT Tissue ~$1B Other CV Edwards Mechanical ~$400M ATS SRN MDT STJ Repair ~$150M STJ STJ MDT STJ Edwards Source: Edwards estimates; displayed growth is FX neutral

3 Tissue Platforms are Driving Growth Traditional drivers of tissue growth have not changed Demographics - aging population Mechanical to tissue conversion Transcatheter valves accelerated market growth in Europe 50% Europe Total HVT Market Revenue Growth 40% 30% 20% Up ~20 pp 10% 0% E Source: Edwards estimates; displayed growth is FX neutral Our Strategy is to Lead, Grow and Transform the Treatment of Heart Valve Disease Lead Surgeon-oriented product innovation Grow Transform Physician-oriented education Preparing for the future Patient-oriented platforms Minimally invasive valves and tools

4 Strategy Drives Market Expansion and Increases Patient Options Population 2014 Europe + U.S. Aortic Population 15,000 10,000 Guidelines/ Treatable 5,000 Open Surgical Tissue THV Tissue 0 Mech Age Source: Edwards estimates Our Focus is Surgical Share Gain and Enabling Market Expansion Edwards HVT Global Sales Trend Reported Revenue ($ in millio ons) THV Tissue Surgical Tissue and Repair Market Expansion Share Gains Surgeon innovation Surgeon education and training Minimally invasive valves and tools E 2009E 14-16% Underlying Growth for both 2008E and 2009E Source: Edwards estimates

5 Lead Surgeon-Oriented Product Innovation Magna Has Become the Leading Valve in the Aortic Segment Edwards Aortic Tissue Sales Driven by Strong Clinical Evidence E MAGNA MAGNA Magna EW MAGNA Sales: EW MAGNA Sales: < $10M > $200M MAGNA upgrade to MAGNA Ease - U.S. launch anticipated in Q Better implantability with lower profile Premium valve driving sales growth and capturing market share in Europe *2003 sales restated at 2008 FX rates

6 2009 MAGNA Mitral Ease Launch Will Build on Magna Mitral Valve Extends the MAGNA Mitral platform to MIS procedures Uniquely designed specifically for the mitral position Best-in-class implantability, performance, and safety U.S. and EU launch of MAGNA Mitral Ease in 2H 2009 Saddle Shape Anterior saddle shape is similar to the Carpentier- Edwards Physio ring Ring Valve Extending Leadership with the Second Generation Physio Ring Physio II - Shape Optimization Designed to treat entire spectrum of degenerative diseases Provides optimal restoration of the diseased valve shape Targets the largest segment of repair EU & U.S. Mitral Procedures Degenerative Functional 32 mm 34 mm 36 mm 38 mm 40 mm Source: Edwards estimates

7 Grow Surgeon-Oriented Services Education Strategy Drives Surgeon Loyalty and Increases Patient Options Education Center of excellence courses Valve summits Symposia Training Simulators Team proctoring and development MIS Procedures Products and preceptor programs Clinical support

8 Transform Patient-Oriented Platforms Transforming the Patient Experience Open Heart Surgery Minimally i Invasive Procedures Transcatheter Therapies Invasive Less Invasive

9 Edwards Lifesciences 2008 Investor Conference Broadest Portfolio of MIS Options Standard Open Heart Approach Port Access Approach Upper Sternotomy Port Access Approach Thoracotomy Broadest Portfolio of MIS Options Standard Open Heart Approach Port Access Approach Upper Sternotomy Port Access Approach Thoracotomy

10 Ascendra - Extending the Standard of Care for High Risk Surgical AS Patients Improve valve placement with better imaging techniques Focus on patient selection and procedure learning curve Enhanced delivery er system stem - Ascendra II Extend platform, additional accessories CAUTION Ascendra is an investigational device. It is limited by United States law to investigational use Heart Valve Therapy Growth Plan Will Exceed Expectations 15% 2008 EW HVT Revenue Growth (Underlying) 10% 8-10% 5% 0% 4-6% 0-2% U.S. Global Global Surgical HVT Surgical HVT Surgical HVT + THV

11 2008 Heart Valve Therapy Growth Plan Will Exceed Expectations 15% 2008 EW HVT Revenue Growth (Underlying) ~15% 10% ~7% 8-10% 5% ~3% 4-6% 0% 0-2% U.S. Global Global Surgical HVT Surgical HVT Surgical HVT + THV Q1: Ascendra launched in Europe Q2: MAGNA launched in Japan Q3: MAGNA Mitral launched in the U.S. Q4: Acquired foundational structural heart IP portfolio 2009 HVT Growth Plan 2009 EW HVT Revenue Growth (Underlying) 15% 14-16% 10% 5% 0% 7-9% 7-9% 5-7% 4-6% % U.S. Global Global Surgical HVT Surgical HVT Surgical HVT + THV 2009 Milestones: MAGNA Ease Launch (U.S. in Q3) Physio II Launch (U.S. and EU in Q1) MAGNA Mitral Ease Launch (U.S. and EU in 2H 2009)

12 30 Days after SAPIEN Implant with Ascendra Ralph Age 70 Edwards SAPIEN recipient *Image courtesy of Joseph E. Bavaria, M.D. Helping Patients is Our Life s Work, and

13 The Evolution of the Cardiac Surgeon Joseph E. Bavaria, MD Roberts-Measy Professor of Surgery Vice Chief: Division of Cardiovascular Surgery University of Pennsylvania Medical Center Penn Cardiovascular Surgery Procedures Breakdown The cardiovascular surgeries performed at PENN Medicine in 2007 reflected a rising trend toward complex, high risk procedures, and are thus representative of the surgical expertise and the increasing presence of technical innovation at Penn. Valve Procedures, n=967 TAP, n=392 Isolated CABG, n=861 *Other Cardiac, n=126 Heart Tx / VAD, n=79 *Cardiac procedures without heart transplant/vad and without aortic aneurysm Lung Tx, n=54

14 Who am I 3000 Standard and Advanced Aortic Valve Procedures (AVR/Aortic Root) 500 Thoracic EndoVascular Aortic Repairs (TEVAR) 40 LVAD s per year (Penn) Partner Transcatheter Valve Trial Site PI Transfemoral TransApical An Unconflicted Physician? University of Pennsylvania Transcatheter Valve Experience 240 Partner Trial Referrals and Evaluations in 1 year 44 Randomized Patients (19 control) 20 Transfemoral 5 Transapical Many Reasons for Non-Randomization (AVR, medical therapy/bav, expired, active follow up, refusal, exclusion, etc)

15 Hybrid OR-The Future How will Transcatheter, e Sapien, and Ascendra Transapical Impact Cardiac Surgery? Answer: Substantially

16 U.S. Population Distribution Population by single year of age and sex, Male population Source: U.S. Census Bureau, Population Estimates Program, July Age Baby boom generation Female population Millions The first baby boomers are Approaching their 60s Many Patients with Severe AS Are Not Surgically Treated 100% Severe AS* Percent of Patients Treated 75% % 25% Untreated Surgically Treated 0% Charlson 2006 Iung 2003 Bouma 1999 US EU * EuroHeart Survey: Single Valve Disease (AS, MR) 1. Charlson E et al. Decision-making and outcomes in severe symptomatic aortic stenosis. J Heart Valve Dis2006;15: Iung B et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. European Heart Journal 2003;24: Bouma B J et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart 1999;82:

17 Multi-Disciplinary Approach The PARTNER Trial JEB performing a Transfemoral Conceptual Transapical Advantages: Patient Characteristics that may favor Transapical Approach Difficult Access Minimal Arch Transit with possible less Stroke Risk More Stable Delivery System

18 Access: No Way! Another Transapical candidate: Posterior View M2S Reconstruction Posterior calcification bilateral

19 D-R Minimal diameters = 8.5 and 8.8 mm: S/P high dose pelvic radiation. Will probably need 26 mm valve. BSA = 2.0 tavr R-M/F-M Tortuous vessels too small for 26mm valve tavr

20 Conceptual Transapical Advantages: Patient Characteristics that may favor Transapical Approach Difficult Access Minimal Arch Transit with possible less Stroke Risk More Stable Delivery System Chest CT Aortic Atheroma Grade J Gutsche, J Bavaria, et al; ATS 2007 Grade II Grade III Grade IV Analyzed from Aortic Valve to 2 cm distal to L subclavian

21 Porcelain Aorta A-P Extensive Cerebral Vessel Calcification off the Aortic Arch Stroke Risk Open AVR

22 Conceptual Transapical Advantages: Patient Characteristics that may favor Transapical Approach Difficult Access Minimal Arch Transit with possible less Stroke Risk More Stable Delivery System Deployment Stability: A matter of Physics!

23 What does this all mean? Cardiac Surgeon Preparation for the future Ultimate t Bailout (Very Important) t) Endovascular/Endocardiac Hybrid OR Suites.. TEVAR, Hybrid Aortic, Hybrid Coronary, Aortic Dissections, and Transcatheter Valves How do Surgeons get the Endo Skill sets? See above, many are already doing it well Junior partners out of training» Present Changes in Training Programs are active! TRAVERCE: TA Feasibility study + - Team approach: Cardiac Surgery, Cardiology, Anaesthesia Communication: Frequent exchange on experience Hybrid OR: One center New procedure: no experience from others (=>intense experimental training) No clear bail-out concepts: (=> e.g. valve in a valve ) C-arm / Cath-lab lab: Two centers

24 1, 0 98 ±2% 0, 8 0, 6 TA- AVI: Leipzig Comparative Survival (n=175) Learning Curve 88 ±3% 73 ±4% Pat ES 37%, STS 13% 71 ±4% 0, 4 0, 2 30 da ays 6 month hs r 1 yea Pat , 2 Pts (CPR) excluded ES 29%, STS 14% 0, Transapical AV - Implantation minimally invasive, off-pump, safe excellent steerability, low stroke risk TRAVERCE: Learning from experience Team: Cardiac Surgery Cardiology Anaesthesia

25 Past: What does this all mean? Referral Patterns Cardiologists (as a group) really didn t understand Heart Valve disease in depth except the ACC/AHA guidelines when to refer to Cardiac Surgery Future: Referral will probably (hopefully for the patient!) go to a multidisciplinary group (or clinic ) that has the knowledge base and expertise to choose the best therapy from all the possibilities. (e.g. the Penn Transcatheter Valve Clinic) The Patient with our Trial Coordinators: It s all about Patients and Choices in all types of Anatomy

26 Thomas Eakins: Gross Clinic and Agnew Clinic Great Progress in 10 years! Thank You Innovations in Critical Care Carlyn D. Solomon Corporate Vice President, Critical Care

27 Edwards Critical Care Serves a Broad Range of Patients & Clinicians Historic Market Growth: 3% to 4% Annually Patients: High risk surgery Cardiovascular disease Complex medical patients, including those with sepsis Shock and trauma patients Pediatric congenital heart disease Clinicians: Anethesiologists i t Intensivists Cardiac Surgeons Critical Care Nurses Source: Edwards estimates Offering a Strong Portfolio of Critical Care Products 2008 Critical Care Sales ~$450 Million Other Oximetry Hemofiltration Pulmonary Artery Catheter FloTrac Hardware, Service Pressure Monitoring

28 Our Focus on Innovation Swan-Ganz Swan-Ganz Oximetry Swan-Ganz Volumetric Advanced SG Combo Advanced SG PreSep Volumetric FloTrac PreSep FloTrac PediSat PediaSat First flowdirected device blood oxygen First to combine to measure the levels and cardiac heart s output pumping capacity (cardiac output) First and only catheter to monitor heart blood volume Breakthrough in continuous cardiac output blood oxygen monitoring First continuous heart blood volume catheter First continuous Venous blood oxygenation sensor First auto - calibrated minimally invasive cardiac output device First continuous pediatric venous blood oxygenation sensor Has Produced a History of Firsts Our Continued Focus on Innovation Will Add New Market Opportunities Swan-Ganz Swan-Ganz Hemodynamic Oximetry Volumetric Monitoring Platform Swan-Ganz Advanced SG Combo Advanced SG PreSep Volumetric FloTrac PreSep PediaSat FloTrac PediSat PediaSat First First auto - First First minimally First continuous continuous First calibrated First continuous auto - invasive First CO heart Venous blood blood continuous minimally pediatric calibrated device continuous adjusting volume oxygenation catheter Venous invasive blood venous minimally blood for pediatric patient sensor oxygenation cardiac output oxygenation invasive cardiac progression venous blood sensor device sensor output device oxygenation sensor Has Produced a History of Firsts

29 Our Continued Focus on Innovation Will Add New Market Opportunities Swan-Ganz Swan-Ganz Hemodynamic Oximetry Volumetric Monitoring Platform Swan-Ganz Glycemic Control in Critically Ill Patients Advanced SG Combo Advanced SG PreSep Volumetric FloTrac PreSep PediaSat FloTrac PediSat PediaSat First First auto - First First minimally First continuous continuous First calibrated First continuous auto - invasive First CO heart Venous blood blood continuous minimally pediatric calibrated device continuous adjusting volume oxygenation catheter Venous invasive blood venous minimally blood for pediatric patient sensor oxygenation cardiac output oxygenation invasive cardiac progression venous blood sensor device sensor output device oxygenation sensor 2009 and increase our revenue growth Benefits of Glycemic Control in Critically Ill Patients Widely Investigated since 2001 We have enough data to justify implementation of programs to monitor and treat hyperglycemia in medical, surgical and trauma ICUs. The discussion these days is where and how we treat. - Dr. James Krinsley, Columbia Univ., 37 th Critical Care Congress 2008

30 Evidence Mounts That Glycemic Control Can Improve Clinical Outcome in ICUs Physiological response to stress Physiological response to aggressive therapy Acute Illness Hyperglycemia Worse clinical outcomes Increased morbidity 30-day increased mortality Increased hospital cost More infections Longer hospital stay Glycemic control is now advocated by many medical society guidelines and quality organizations Evidence Mounts That Glycemic Control Can Improve Clinical Outcome in ICUs Physiological response to stress Physiological response to aggressive therapy Acute Illness Glycemic control is now advocated by many medical society guidelines and quality organizations

31 Evidence Mounts That Glycemic Control Can Improve Clinical Outcome in ICUs Physiological response to stress Physiological response to aggressive therapy Acute Illness Normoglycemia Less morbidity and mortality Improved hospital bottom line by fewer infections and shorter hospital stays Glycemic control is now advocated by many medical society guidelines and quality organizations These Mortality Benefits Can Extend to ICU Patients with Many Types of Conditions Corstjens et al, Critical Care 2006, 10:216

32 Committed to Providing Clinicians with Best In-Hospital Continuous Glucose Sensor Global sales channel 30+ years of knowledge in intravenous catheters and sensors Expertise in clinical education Future implementation on existing products & monitors (Swan Ganz catheters, PreSep, etc.) Deep sensor experience Closest to commercial readiness Performance expected to equal current strip technology Robust IP portfolio Achieve accuracy and performance trusted by clinicians to direct therapy Achieve reliability for several days use Design cost-effective product Gain straightforward regulatory approval Demonstrate technical success Complete clinical studies Demonstrate regulatory success Responsibilities and Financial Impact Global Sales Global Distrib. & Marketing Technical Direction System Development Manufacturing One time Q4 charge Incremental R&D spending Meaningful sales Earnings contributor

33 Glucose Opportunity Summary Glycemic control market for critically ill patients already exists and has upside potential Edwards has repeatedly and successfully introduced monitoring systems Edwards has been investigating glycemic control for 3 years Combining Edwards and DexCom technologies will likely yproduce a leading gproduct Glycemic control in the ICU is a potential growth platform for the company s critical care franchise FloTrac: A Premium Product in a Growing Market FloTrac is the only device to: Use an existing catheter Auto calibrate as patient s condition changes Provide fast, easy setup Business model generates profitable revenue stream Sell disposable Sell monitors Sell service

34 FloTrac Establishes Leadership in 3 Years & Expands the Market Edwards FloTrac Edwards vs. Competition Revenue (millions) High Risk Surgery Enhancement FloTrac Launch E 2009E More Patients, More Parameters, Continued Growth Edwards FloTrac Adaptable Minimally Invasive Hemodynamic Monitor OR & ICU Applicability Enhancement Revenue (millions) High Risk Surgery Enhancement FloTrac Launch E 2009E

35 Critical Care Driving Sustained Growth Revenue (millions) Underlying Revenue Growth Rate ~8% 6-9% 10.4% Critical Care 8.6% 64% 6.4% 3.4% 4.2% 3.2% E 2009E FloTrac Oximetry Hemofiltration Pressure monitoring Excludes discontinued businesses and impact of FX. Summary Edwards has a unique global channel to the critical care market Core products command leading positions FloTrac continues to lead Critical Care growth Glycemic control in the ICU is a potential growth platform Our new technologies are improving our profitability and have the potential to accelerate growth rates toward double-digits

36 Helping Patients is Our Life s Work, and