Health & Fitness
Health and Fitness
Health and Fitness 
Fri, December 12, 2008
Thu, December 11, 2008
Edwards Lifesciences : Edwards Lifesciences Projects 2009 EPS Growth of 15 to 19 Percent
NEW YORK, NY--(Marketwire - December 11, 2008) - Edwards Lifesciences Corporation (
"We anticipate 2009 will be a very successful year for Edwards Lifesciences as we plan to deliver increasing profitability and continued investment in future growth," said Michael A. Mussallem, chairman and CEO. "We expect to extend our leadership in our core franchises with underlying sales growth of 10 to 12 percent, although the LifeStent divestiture and recent changes in foreign currencies will reflect minimal growth in reported sales. Sales of our market expanding transcatheter valves are expected to grow to $75 to $95 million in 2009."
During the conference, Edwards' management also will present the company's financial goals for 2009, including total sales between $1.24 billion to $1.30 billion, a gross profit margin of 68 to 70 percent, earnings per share growth of 15 to 19 percent, excluding the impact of special items, and free cash flow of $160 million to $170 million. "We currently expect our hedging program to neutralize the foreign currency impact on our bottom line, resulting in projected earnings of $2.93 to $3.03 per share, which represents 15 to 19 percent growth," said Mussallem.
Among the specific topics to be discussed at today's event are: -- Transcatheter Heart Valve Therapy -- Edwards has enrolled the first patient in the clinical study of its next generation Edwards SAPIEN XT transcatheter valve in Europe, which offers a smaller delivery profile and state of the art valve design. In the U.S., enrollment in the PARTNER pivotal trial has met year-end projections and overall timing for completion remains on track. Additionally, the company plans to broaden its presence in Europe and expand into a number of international markets in 2009. -- Heart Valve Therapy -- Edwards expects to strengthen its leadership position with the launch of several new products, including the U.S. introduction of its PERIMOUNT Magna Ease aortic valve. Together with transcatheter valve sales, Edwards expects to generate 14 to 16 percent underlying Heart Valve Therapy sales growth in 2009. -- Critical Care -- Building upon its decades-long global leadership in hemodynamic monitoring systems, Edwards recently invested in additional technology for its FloTrac minimally invasive monitoring system to drive future growth. The company will also discuss its exciting new growth opportunity for continuously monitoring blood glucose levels in hospitalized patients. -- Financial Outlook -- The company will reaffirm its earnings guidance for the fourth quarter of 2008, which will result in a full year earnings per share growth rate of approximately 20 percent. Edwards will also detail its financial expectations for 2009. Other members of Edwards' management team attending the conference include: Thomas M. Abate, corporate vice president, chief financial officer and treasurer; Donald E. Bobo, Jr., corporate vice president, Heart Valve Therapy; Carlyn D. Solomon, corporate vice president, Critical Care; Patrick B. Verguet, corporate vice president, Europe; and Larry L. Wood, corporate vice president, Transcatheter Valve Replacement.
Guest Speakers Provide Clinical Perspective
Also speaking at the conference are interventional cardiologist Dr. Alec Vahanian, Head of the Cardiology Department at Bichat University Hospital in Paris, France, and Dr. Joseph E. Bavaria, Vice-Chief, Division of Cardiothoracic Surgery at University of Pennsylvania in Philadelphia, who will detail their clinical experiences with transcatheter aortic valve therapies.
LifeStent PMA Application Transferred
Edwards also announced today that it has received an approvable letter from the FDA for the LifeStent product line and has completed the transfer of its PMA application to C.R. Bard, Inc., which purchased the line in January 2008. In exchange, Bard has paid Edwards $23 million of the previously negotiated $50 million milestone payment. The remaining $27 million will be paid upon receipt of the PMA, which is expected in 2009.
Webcast Information
The Edwards Lifesciences 2008 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 11, 2008. The webcast will also be archived on the Edwards website after the conference concludes.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies. In 2008, Edwards celebrates 50 years of partnering with clinicians to develop life-saving innovations. The company's global brands, which are sold in approximately 100 countries, include CardioVations, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz. 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 include, but are not limited to, the company's ability to achieve financial goals for sales, gross profit margin, net income, earnings per share and free cash flow; regulatory approval of new products in, and competitive dynamics associated with, the company's heart valve therapy product line; the continued adoption and sales of the FloTrac system; the timing and progress of clinical studies relating to the company's transcatheter valve technologies 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.
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 creating new market opportunities for its products and the timing of new product launches; 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, 2007.
Edwards, Edwards SAPIEN XT, and Magna Ease are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office. CardioVations is a trademark of Edwards Lifesciences AG and is registered in the United States Patent and Trademark Office.
LifeStent is a registered trademark of C.R. Bard, Inc.