SOURCE: Edwards Lifesciences

Edwards Lifesciences

December 13, 2010 08:30 ET

Edwards Lifesciences Projects Double-Digit 2011 Sales Growth and Plans Fourth Quarter U.S. THV Launch

-- Transcatheter Valve Sales of $300 to $340 Million Expected

-- 20% R&D Increase and $40 Million U.S. THV Launch Investment

-- New PARTNER II Trial Design Randomizes to SAPIEN

NEW YORK, NY--(Marketwire - December 13, 2010) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today will provide investors with information on the initiatives expected to result in double-digit sales growth in 2011. During its annual investor conference in New York City, Edwards' management will also discuss the company's strategy for long-term growth, technology pipeline, U.S. transcatheter valve launch and financial goals for 2011.

"We expect 2011 will be a very successful and eventful year for Edwards Lifesciences as we continue to deliver strong sales growth while investing aggressively to drive long-term growth," said Michael A. Mussallem, chairman and CEO. "We project underlying(1) sales growth of 11 to 15 percent as we extend our leadership in our core franchises. Sales of our market-expanding transcatheter valves are expected to grow to between $300 million and $340 million in 2011. We also plan to invest approximately $40 million to prepare for the U.S. launch of our SAPIEN transcatheter heart valve. While this will moderate earnings growth in 2011, it allows us to aggressively address this large unmet patient need." 

During the conference, Edwards' management will also present the company's financial goals for 2011, which include total sales between $1.59 billion and $1.67 billion, a gross profit margin of 71 to 73 percent, net income growth of 6 to 8 percent, excluding special items, and free cash flow of $190 million to $200 million(2). "Our financial strength and global leadership enable us to increase our investment in research and development by 20 percent, which should position us well for the multi-billion dollar opportunity represented by our innovative technologies," said Mussallem.

Among the specific topics to be discussed at today's event are:

  • Transcatheter Heart Valve Therapy -- A number of substantial developments are expected during 2011 in both the commercial and clinical trial settings. Edwards anticipates launching its SAPIEN transcatheter valve in the U.S. during the fourth quarter, pending regulatory approval. Fourth quarter sales in the U.S. are estimated to be $20 million to $25 million, and sales for the first four quarters of the U.S. launch are projected to be $150 million to $250 million. 

    Edwards will also discuss expected modifications to the design of Cohort B of The PARTNER II Trial, which is anticipated to begin enrolling in early 2011. The new design will study Edwards SAPIEN XT compared to SAPIEN in up to 500 patients with severe, symptomatic aortic stenosis using one-to-one randomization. The company expects to complete enrollment in Cohort B by the end of 2011. 

    Additionally, the timing of Cohort A from The PARTNER Trial remains on track and the company anticipates U.S. approval in 2012.

  • Heart Valve Therapy -- Edwards' recent product launches and robust pipeline are expected to fuel continued share gains. The innovative Edwards INTUITY valve system (formerly referred to as Project Odyssey) will expand minimally invasive options for patients, and the company anticipates a European launch in the second half of 2011. Including transcatheter valve sales, Edwards expects to generate 16 to 20 percent underlying Heart Valve Therapy sales growth in 2011.

  • Critical Care -- Building upon its global leadership in hemodynamic monitoring systems, Edwards expects its advanced monitoring products to continue to fuel growth and drive gross profit margin improvement. The company anticipates its new VolumeView system and EV1000 clinical platform will strengthen its medical intensive care unit product portfolio in 2011. Additionally, Edwards continues to make progress on its GlucoClear hospital glucose monitoring system and expects a 2012 launch.

  • Financial Outlook -- The company will reaffirm its guidance for the fourth quarter of 2010, and detail its expectations for 2011. Excluding special items, Edwards expects earnings per share of $1.91 to $1.97 for 2011, which includes the investment for the U.S. launch of SAPIEN. 

Other members of Edwards' management team presenting at the conference include:

Thomas M. Abate, corporate vice president and chief financial officer;
Donald E. Bobo, Jr., corporate vice president, Heart Valve Therapy;
Dr. Frederic Michard, director, Medical Strategy, Critical Care;
Carlyn D. Solomon, corporate vice president, Critical Care; and
Larry L. Wood, corporate vice president, Transcatheter Valve Replacement.

Guest Speakers Provide Clinical Perspective

Also speaking at the conference are interventional cardiologist Dr. Martin B. Leon, Professor of Medicine and Director, Center for Interventional Vascular Therapy at Columbia University Medical Center in New York, and cardiothoracic surgeon Dr. Michael A. Borger, Professor of Medicine, Cardiothoracic Surgery Leipzig University and Associate Director, Leipzig Heart Center in Leipzig, Germany, who will detail their clinical experiences with heart valve therapies.

Webcast Information

The Edwards Lifesciences 2010 Investor Conference can be accessed via live webcast at http://www.edwards.com/investorrelations/investorconference.htm beginning at 9:00 a.m. Eastern Time on December 13, 2010. The webcast will also be archived on the Edwards Web site after the conference concludes.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Additional company information can be found at www.edwards.com.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements can sometimes be identified by the use of words such as "may," "will," "should," "anticipate," "believe," "plan," "project," "estimate," "expect," "intend," "guidance," "outlook," "optimistic," "aspire," "confident" or other forms of these words or similar expressions and may include, but are not limited to, the Company's financial goals or expectations for sales and sales growth, gross profit margin, net income and net income growth, earnings per share and earnings per share growth and free cash flow and other financial expectations; regulatory approval of new products in, and competitive dynamics associated with, the Company's heart valve therapy product line; the timing and progress of clinical studies relating to the Company's transcatheter valve technologies, the development and introduction of new products and the market opportunity for these products; 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 believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. If the Company does update or correct one or more of these statements, investors and others should not conclude that the Company will make additional updates or corrections.

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 include the opportunities for the Company's transcatheter valve programs and the ability of the Company to continue to lead in the development of this field; the Company's success in developing new products, obtaining regulatory approvals, creating new market opportunities for its products and the timing of new product launches; the availability and amounts of reimbursement for the Company's products, the availability of competitive products, the impact of currency exchange rates; the timing or results of pending or future clinical trials; actions by the U.S. Food and Drug Administration and other regulatory agencies; and other risks 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, 2009. 

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN XT, EV1000, GlucoClear, Edwards INTUITY, PARTNER, PARTNER II and VolumeView are trademarks of Edwards Lifesciences Corporation.

(1) "Underlying" growth assumes a constant foreign currency rate in 2010 and 2011.

(2) Free cash flow is defined as cash flow from operating activities less capital expenditures.

Contact Information

  • Investor Contact:
    David K. Erickson
    949-250-6826

    Media Contact:
    Amanda C. Fowler
    949-250-5070