The Leader in the Science of Heart Valves and Hemodynamic Monitoring

Transcription

1 The Leader in the Science of Heart Valves and Hemodynamic Monitoring

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 forwardlooking statements include, but are not limited to, the company s financial expectations for 2010 including sales, gross profit margin, net income, earnings per share and free cash flow; the regulatory approval and sales of heart valve therapy products; the continued adoption and 2010 sales of the Edwards d SAPIEN valve; the timing, progress and results of clinical lstudies including the PARTNER trial and the U.S. approval of SAPIEN; expected sales and enhancements for the FloTrac system; the development of blood glucose monitoring technology; and the impact of foreign exchange and special items on the company s results. Forward looking statements are based on estimates and assumptions made by management of the company and are bli 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, 2008.

3 Edwards Today: The Global Leader in its Core Businesses Global HVT Market* Heart Valve Therapy Largest and most profitable franchise Unmatched product pipeline Transformingg valve treatment Other Edwards Sorin $1.6 ~$1 6 billion Critical Care Technologies MDT Unique global channel Innovating I ti tto address dd unmett needs Over 90% of sales from products with #1 global positions High barriers to entry and strong brand recognition *2009 estimated sales STJ Global Gl b lh Hemodynamic d i Monitoring Market* Other Pulsion ICU x Medical ~$540 million Edwards

4 Edwards Product Lines

5 Edwards is Positioned for Continued Growth in Heart Valve Therapy Global heart valve opportunity is strong and growing Demographics / aging population New technologies will further accelerate growth and expand an underserved market Transcatheter heart valves (THV) have accelerated underlying ggrowth in Europe 14% to 17% projected growth in 2010* Edwards Surgical HVT has extended leadership 2009 product launches fueled strong revenue growth and provides momentum into 2010 Minimally invasive valve surgery will transform surgeon and patient experiences *Estimated underlying sales growth rate

6 New Surgical Product Launches Will Continue to Fuel Revenue Growth Magna Ease: U.S Better implantability with lower profile Premium aortic valve will drive sales growth and market share Magna Mitral Ease: U.S. & EU 2010 Extends Magna Mitral platform to minimally invasive valve surgery procedures Adds best-in-class implantability to performance Physio II: US & EU 2009; Japan 2010 Extends leadership in mitral repair, the largest repair segment Designed to treat t entire spectrum of degenerative disease

7 Minimally Invasive Valve Surgery (MIVS) will Transform Surgeon and Patient t Experiences e Project Odyssey: a new aortic platform leveraging the Magna valve design withprocedural innovation Pre clinical studies underway FIM expected January 2010 Expected value point: $12 $18K Benefits of MIVS: Project Odyssey Faster procedure Small incision Rapid Tissue deployment Potential for shorter recovery time

8 Edwards is Transforming the Treatment of Heart Valve Disease with Transcatheter Heart Valve Therapy A beating heart alternative to traditional surgery for high risk AS patients Approximately 200 centers in 30 countries performing cases High acute procedural success Strong clinician enthusiasm and visibility at major medical meetings U.S. U S PARTNER trial completely enrolled Catheter entrance

9 Edwards is Continuing to Extend its Leadership Position in Transcatheter Heart Valve Therapy Edwards focus has been, and will continue to be, on clinical i l success Estimated 2010 sales of $170 $190 million Formal reimbursement approved in Germany and France; transitional funding elsewhere continues to exist Groundbreaking PARTNER trial going well Confidence in trial design Cohort B data release in 3Q 10 Submit Cohort B PMA in 4Q 10 U.S. approval anticipated in late 2011

10 SAPIEN XT Expands the Treatable Patient Population Increased frame strength at a lower profile Enables access to smaller vessels Europe introduction in 1Q 10 Expand to globalregions throughout the year Expect U.S. IDE trial approval (1Q 10) Commence Japan trial (2Q 10) Edward SAPIEN XT RetroFlex 3 Delivery System Stainless Steel Frame Tissue Leaflets Guidewire Lumen Balloon Material Cobalt Chromium Frame Tissue Leaflets Guidewire Lumen NovaFlex Delivery System

11 The Global THV Opportunity is Large 30 60% of patients with severe aortic stenosis go untreated Transcatheter valve market opportunity expected to exceed $2 billion in 4 to 5 years Increase attributed to: Stronger performance in Europe Continued expansion in rest of world Reven nue (in millions) $2,500 Aortic THV Market Revenue (Global) $2,000 $1,500 $1,000 $500 More optimistic U.S. outlook $0 Assume late 2011 U.S. approval 2008 Assumption (E.U. & U.S. Only)

12 Strong Fundamentals in Place for U.S. Launch Comparison On Day One of Launch Europe United States Patient Experience ~200 Over 20,000 Training Program Early stage Well developed Clinical Data Limited data with short term follow up No randomized trial Mid term data Robust randomized trial # Active Sites 10 Over 25 North America, Over 200 OUS Reimbursement e Not Established Expected

13 Critical Care: Market Leading Technologies Serving a Wide Range of Patients Pulmonary Artery Catheters (PACs) Gold Standard d for complex cases Most trusted hemodynamic monitoring sensor Pressure Sensors Provides highest quality and operational excellence FloTrac System Ease to use, accurate andless invasive Auto calibrates as patient s condition changes 5% 8% projected growth in 2010* Swan-Ganz Catheter t TruWave Disposable Pressure Transducer FloTrac Sensor and 5% 8% j d h i 2010* Vigileo Monitor * Estimated underlying sales growth rate

14 Launching New Line of Sensors and Novel Integrated Monitoring Platform in2010 EV1000 system screens and integrated hardware platform Launch expected in 2Q 2010 EV1000 Integrated Hardware Platform VolumeView catheter for pulmonary conditions VolumeView catheter

15 Edwards is Introducing an Automated Glucose Sensor for the Hospital Evidence mounting that glycemic control can improve clinical i l outcomes in ICUs Glycemic control advocated by many medical societies Current glycemic control methodsare burdensomeand can potentially compromise patient care 2009 Demonstrated accuracy, performance and reliability Accomplishments Received CE Mark 2010 Objectives File for U.S. regulatory clearance Post approval trials in Europe to gain real world experience in a variety of clinical situations Implement system enhancements

16 A Clear Growth Strategy and Strong Financial Performance

17 Edwards Today: The Global Leader in its Core Businesses Focused approach Structural heart disease and critical care technologies Large and growing patient populations with significant unmet clinicalneeds needs Innovation strategy Transform patient care through innovative technologies with clinical superiority Leads to improvements in healthcare economics Active portfolio management Identify additional technologies that are closely aligned with strategy

18 Edwards is Committed to Extending its Leadership Through Innovation ~ $200 Million* Critical Care Technologies Surgical Heart Valves & MIS Transcatheter Heart Valves l Advanced Technologies * 2010 estimated R&D investment 2010 R&D investment is f focused d on emerging i technologies

19 2010 Financial Goals 2010 Financial Goals: Net sales of $1,430 $1,500 million Gross profit margin increase of b.p. Net income growth of 17 19% Free cash flow of $190 $200 million Excludes special items

20 Delivering Bottom Line Growth While Generating Consistent Free CashFlows $250 Net Income $250 Free Cash Flow $200 $200 $150 $150 $100 $100 $50 $50 $0 '04 '05 '06 '07 '08 '09E '10E $0 '04 '05 '06 '07 '08 '09E '10E Dollars in millions; Excludes special items; Adjusted for FAS123(R) option expense prior to 2006

21 Transcatheter Platform Adds Significant Longer Term Revenue Growth EW Global Sales 5 Year CAGR 8% E EW Global Sales 5 Year CAGR 14 18% '03 '04 '05 '06 '07 '08 '08 '09E '10E '11E '12E '13E Excluding special items; assumes current FX rates

22 Edwards Lifesciences... is a global leader in its core franchises has a focused strategy operates in attractive, growing gmarkets is pursuing exciting new growth opportunities is financially strong

23 Helping Patients is Our Life s Work, and