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View Annual Report Edwards Lifesciences Corporation 2009 Annual Report Edwards Lifesciences Corporation One Edwards Way, Irvine, California 92614 Stronger (800) 4-A-HEART or (949) 250-2500 www.edwards.com Hearts From Innovative Minds the innovative minds at Our Credo Edwards Lifesciences are At Edwards Lifesciences, we are dedicated to providing innovative solutions for people working hard to provide the fighting cardiovascular disease. through patients of tomorrow with our actions, we will become trusted stronger and healthier hearts. partners with customers, colleagues and Our commitment reaches patients creating a community unified beyond today’s technology. In in its mission to improve the quality of life around the world. Our results will partnership with clinicians, we benefit customers, patients, employees are working to discover entirely and shareholders. We will celebrate new approaches in the areas our successes, thrive on discovery and of structural heart disease and continually expand our boundaries. critical care monitoring that We will act boldly, decisively and with determination on behalf of people fighting will save, enhance and preserve cardiovascular disease. Helping Patients is patients’ lives. Our Life’s Work, and Life is Now. Selected Operating Information Twelve months ended December 31, (in millions) 2 0 0 9 2 0 0 8 2 0 0 7 Net sales $ 1,321.4 $ 1,237.7 $ 1,091.1 Cost of goods sold 399.1 419.6 378.2 Gross profit 922.3 818.1 712.9 Selling, general and administrative expenses 508.8 480.6 418.0 Research and development expenses 175.5 139.2 122.3 Operating Statistics As a percentage of net sales: Gross profit 69.8% 66.1% 65.3% Selling, general and administrative expenses 38.5% 38.8% 38.3% Research and development expenses 13.3% 11.2% 11.2% Operating margin (a) 18.0% 16.0% 15.8% (a) Operating margin is calculated by subtracting selling, general and administrative expenses and research and development expenses from gross profit and then dividing by net sales. The information contained in the table above should be read in conjunction with Edwards Lifesciences’ “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Consolidated Financial Statements” found in the accompanying Annual Report on Form 10-K for fiscal year ended December 31, 2009. Safe Harbor Statement This Annual Report contains forward-looking statements within the meaning of the federal securities laws. These statements involve substantial risks and uncertainties that could cause the company’s future business, financial condition, results of operations or performance to differ materially from that expressed or implied by the forward-looking statements. All statements other than statements of historical fact in this Annual Report or referred to or incorporated by reference into this Annual Report are “forward-looking statements.” You are encouraged to refer to the discussion of Risk Factors that may be found in the company’s Annual1 Report 2009 Annual on Form Report 10-K for fiscal year ended December 31, 2009 and other filings with the Securities and Exchange Commission. Selected Consolidated Data For a reconciliation of GAAP to non-GAAP figures, refer to pages 18 and 19 of this report. Net Sales (in billions of dollars) R&D Investment (in millions of dollars) 1.3 175 1.2 139 122 1.1 114 1.0 1.0 103 2005 2006 2007 2008 2009 2005 2006 2007 2008 2009 In 2009, net sales grew to more than $1.32 billion, Edwards continues to invest in the development of exceeding our full year goal of $1.24 to new technologies, including transcatheter valves, $1.30 billion. Over 90% of the company’s sales minimally invasive aortic valve surgery systems and came from products in leadership positions. real-time glucose monitoring. R&D investment grew 26% year-over-year from 2008 to 2009. 2 Edwards Lifesciences Stock Performance* Non-GAAP Diluted Edwards RXP (Morgan S&P 500 Lifesciences Stanley Healthcare Earnings Per Share (in dollars) Products Index) 3.05 $250 $200 2.55 $150 $100 2.06 2.13 $50 1.76 $0 2005 2006 2007 2008 2009 12/04 12/05 12/06 12/07 12/08 12/09 Adjusted earnings per share growth of 19.6% in 2009 Since 2004, Edwards’ stock price has increased 110%, exceeded our full year goal of 15% to 19%. For the outperforming the broader market and our medical second consecutive year, adjusted earnings per share products peer group. Year-over-year appreciation of growth surpassed 19%. EW stock from 2008 to 2009 was 58%. Edwards Lifesciences Corp. 100 101 114 111 133 210 S&P 500 100 105 121 128 81 102 Morgan Stanley Healthcare Products 100 102 112 114 94 107 *Cumulative total return based upon an initial investment of $100 on December 31, 2004, with dividends reinvested. 3 2009 Annual Report A Letter To Cardiovascular Our Stockholders disease is a from global burden encountered by Michael A. Mussallem Chairman & Chief Executive Officer millions of people. Each year, an estimated 500,000 people undergo open-heart surgery to replace or repair their malfunctioning or diseased heart valves and virtually all high- risk patients in the operating room or intensive care unit are candidates for having their cardiac function monitored. 4 Edwards Lifesciences The fight to make a positive difference product introductions in the repair and in the lives of these patients and their replacement segments driving global families requires meaningful innovation to growth. In particular, the introduction enhance today’s technologies. Edwards of a new aortic valve and repair ring Lifesciences’ 50-year commitment to helped lift the U.S. growth rate. In 2009, discovery has led to many of the most on an underlying basis, we gained share advanced heart valve therapies and and grew our global surgical heart valve critical care monitoring technologies in therapy product line by 8 percent, faster the industry. In 2009, we continued to than the market growth rate. build upon this legacy by introducing several new products and furthering our In our transcatheter heart valve product progress in developing new technologies line, the number of valve procedures designed to transform patient care. performed commercially in Europe and abroad more than doubled compared to the Another Successful Year of Growth in 2009 prior year. With surgical and transcatheter In a year of slow economic growth, valves combined, our Heart Valve Therapy Edwards not only continued to build on our franchise grew almost 18 percent on an distinguished track record, but also met or underlying basis. exceeded all of our 2009 financial goals. We achieved total reported sales of $1,321 million, Since receiving CE Mark in 2007, thousands which represents an 11 percent underlying of patients have benefited from the growth rate. We stayed very focused on revolutionary Edwards SAPIEN transcatheter delivering strong growth while improving heart valve. We are pleased to be able to profitability, and in 2009 our gross profit offer this life-saving technology to patients margin reached 69.8 percent. In addition, in over 30 countries whose severe aortic we achieved full year non-GAAP diluted stenosis largely goes untreated. earnings per share growth of 19.6 percent and generated non-GAAP free cash flow of In the U.S., we completed enrollment $178 million, beating our $160 to $170 million of our landmark PARTNER Trial—the goal. Our shareholders were rewarded with a world’s only randomized, pivotal clinical 58 percent increase in share value for 2009. trial of a transcatheter aortic valve— which assures our substantial lead in During 2009, we planned to increase the providing this therapy to a large patient growth of our market leading surgical population. We applaud the trial’s Heart Valve Therapy products, extend our investigators for their significant efforts leadership in Transcatheter Heart Valves in meeting this important milestone, and raise our Critical Care growth rate and for their dedication to the follow- through innovation. up that continues into 2010 and beyond. Assuming a favorable outcome and a one I am proud of the accomplishments we year approval process, we would expect made in surgical heart valves, with major U.S. approval of our Edwards SAPIEN 5 2009 Annual Report transcatheter heart valve in 2011. In Japan, We are fortunate that our strong we completed our first compassionate operating performance and cash flow use cases and look forward to starting a enabled us to continue helping worthy clinical trial in 2010. organizations make a difference, and in 2009 our Board of Directors Building upon this momentum, we made approved a $15 million contribution to excellent progress on our next-generation The Edwards Lifesciences Fund, which Edwards SAPIEN XT transcatheter heart will allow us to have a positive impact valve, which enables access to smaller on our global communities for years to arteries, thereby expanding the treatable come. During the year, the Fund made patient population. In the U.S., we submitted grants of $4.6 million to more than 100 our study design for the Edwards SAPIEN nonprofit organizations. XT valve to the FDA and expect to begin enrolling patients in 2010. This trial, called Ensuring Innovative Minds Help Provide PARTNER II, includes both our new 18 French Patients with Stronger and Healthier Hearts NovaFlex transfemoral and the Ascendra Key to our company’s success is 2 transapical delivery systems. And, our developing innovative and enduring progress continues with the recent CE Mark products that not only fuel top line for the Edwards SAPIEN XT next generation growth, but also enable clinicians to make transcatheter valve and its delivery systems, a positive difference in the lives of the leading to a European rollout in 2010. patients they treat.
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