IRVINE, Calif., Nov. 30 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation , the world leader in products and technologies to treat advanced cardiovascular disease, today will provide investors with information on the initiatives expected to drive sales growth and profitability in 2006 and beyond, during its 2005 Investor Conference at its corporate headquarters in Irvine, Calif. Included will be presentations on Edwards’ near-term growth initiatives, market expansion opportunities and longer-term programs in minimally invasive and percutaneous heart valve therapies.
“Edwards Lifesciences’ leadership in advanced cardiovascular technologies, and our long history of successfully commercializing market-leading heart valve and critical care innovations, provides a solid foundation from which to launch our new, market-expanding growth initiatives,” said Michael A. Mussallem, Edwards’ chairman and CEO.
During the conference, Edwards’ management also will communicate the company’s outlook for financial performance in 2006, including projected sales of $1.02 to $1.06 billion, or 8 to 10 percent underlying growth, which excludes the impact of foreign exchange and discontinued businesses. Additionally, the company expects to grow net income 12 to 15 percent, increase its gross profit margin by more than 150 to 200 basis points and generate free cash flow (cash flow from operating activities minus capital expenditures) of $140 to $150 million.
Among the specific topics to be discussed at today’s event are (in order): - Heart Valve Therapy -- Edwards will highlight developments in its broad line of market-leading replacement heart valves and repair products. “Our premier PERIMOUNT tissue valves are continuing to gain share, enabling us to further extend our leadership position in the heart valve market,” said Mussallem. “Specifically, the demonstrated superior performance of our PERIMOUNT Magna aortic valve, along with our unmatched product pipeline, will drive an underlying growth rate of 10 percent again in 2006. We are confident that these products will enhance Edwards’ role as the global heart valve therapy leader for years to come.” Edwards also will be discussing its newest heart valve technology, the Ascendra system for the minimal access, beating-heart surgical replacement of a patient’s aortic heart valve. Surgeons using this novel system, which includes Edwards’ proprietary Cribier-Edwards aortic valve, performed the Trans-Apical Placement, or “TAP” procedure, in which a suture-less, stent-mounted aortic valve is surgically delivered through a mini-incision in the chest. - Percutaneous Valve Initiatives -- In addition to developing new advances in surgical heart valve therapies, Edwards leads the industry with the most comprehensive portfolio of percutaneous heart valve technologies intended to treat patients through catheter-based systems. “We are very enthusiastic about our portfolio of percutaneous valve technologies, which offer treatment options to patients who are not surgical candidates, and have the potential to substantially expand the overall heart valve therapy market,” Mussallem said. Edwards’ percutaneous aortic valve replacement program continues to make good progress. “We remain confident that we will receive approval to resume our U.S. clinical trial by the end of the year, which will include our new custom retrograde delivery system and 26 millimeter valve,” said Mussallem. - FloTrac -- Building upon its decades-long global leadership in hemodynamic monitoring systems with its Swan-Ganz line, Edwards’ FloTrac minimally invasive monitoring system continues to generate clinician excitement and will enable expansion of the critical care market, as well as contribute meaningful growth in 2006. - Peripheral Vascular Platform -- “Clinician feedback on LifeStent is very positive, and the early results from our RESILIENT clinical trial, which seeks to assess LifeStent’s ability to address the unique clinical demands of treating superficial femoral arteries, are quite favorable. We expect to launch new products and report additional RESILIENT trial results in 2006,” said Mussallem. - Financial Outlook -- In addition to providing additional details that comprise the Company’s financial goals for 2006, Edwards’ management will reiterate its confidence for achieving its previously stated financial goals for the fourth quarter of 2005 and its ability to meet or exceed its 2005 financial goals.
Other members of Edwards’ management team presenting at the conference include:
Keith A. Reisinger, corporate vice president, Technology, and J. Alex Martin, president, North America, who will discuss Edwards’ Heart Valve Therapy platform and product pipeline; Stanton J. Rowe, corporate vice president, Percutaneous Valve Interventions (PVI), Donald E. Bobo, Jr., vice president and general manager, PVI -- Repair, and Larry L. Wood, vice president and general manager, PVI -- Replacement, who will provide updates on the company’s three percutaneous heart valve initiatives; Stuart L. Foster, corporate vice president, Technology & Discovery, Carlyn D. Solomon, vice president, Corporate Strategy and general manager, Cardiac Surgery Systems, and Mark S. Harty, vice president and general manager, Critical Care, who will discuss Edwards’ Peripheral Vascular platform Cardiac Surgery Systems platform, and Critical Care platform, respectively; and Corinne H. Lyle, Edwards’ chief financial officer, who will discuss expectations for the fourth quarter of 2005 and present the company’s guidance for full year 2006. Guest Speakers Provide Clinical Perspective
Opening the conference yesterday evening was Alain G. Cribier, M.D., chief of cardiology, Hopital Charles Nicolle, Rouen, France, who detailed his development and clinical experience in percutaneous aortic valve replacement. Today’s portion of the conference will feature presentations by cardiac surgeon Steven F. Bolling, M.D., professor of surgery, section of cardiac surgery, University of Michigan, Ann Arbor, Mich., who will discuss the changing role of the cardiac surgeon; and Maurice E. Sarano, M.D., professor of medicine, and cardiovascular diseases and internal medicine consultant, Mayo Clinic, Rochester, Minn., who will provide his perspectives on identification and early intervention in untreated heart valve patients.
Webcast Information
The Edwards Lifesciences 2005 Investor Conference can be accessed via live webcast at www.edwards.com/InvestorRelations/EventCalendar.htm beginning at 11:00 a.m. Eastern Standard Time on November 30, 2005. The webcast will also be archived after the conference concludes at www.edwards.com/InvestorRelations/Presentations.htm.
About Edwards Lifesciences
Edwards Lifesciences, a leader in advanced cardiovascular disease treatments, is the number-one heart valve company in the world and the global leader in acute hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards focuses on specific cardiovascular opportunities including heart valve disease, peripheral vascular disease and critical care technologies. The company’s global brands, which are sold in approximately 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, Fogarty, LifeStent, PERIMOUNT and Swan-Ganz. Additional company information can be found at http://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 are subject to substantial risks and uncertainties including, but not limited to, the ability to launch new, market-expanding technologies; the ability to achieve 2006 financial goals including $1.02 to $1.06 billion in sales, a 150 to 200 basis point increase in gross profit margin, net income growth of 12 to 15 percent excluding the impact of special items and option expensing, and free cash flow of $140 to $150 million; the ability to meet or exceed 2005 financial goals; the ability to sustain double-digit underlying sales growth in 2006 and maintain global leadership for years to come; the ability to successfully commercialize the Ascendra valve replacement system; the potential for percutaneous valve technologies to substantially expand the overall heart valve therapy market and the ability for Edwards to resume or continue clinical studies of these programs; the ability to successfully complete the RESILIENT clinical trial and its impact on LifeStent sales; the ability of FloTrac to contribute meaningfully to growth in 2006; and more generally, the ability to obtain regulatory approvals for and market new products; the ability to generate and maintain sufficient cash resources to increase investments in the company’s businesses, repay debt or repurchase shares; the success and 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; technological advances in the medical field; product demand and market acceptance; changing conditions in the economy in general and in the healthcare industry; 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, 2004. These 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. Actual results or experience could differ materially from that expressed or implied by forward-looking statements.
Ascendra, Cribier-Edwards, FloTrac, GeoForm, IMR Etlogix, Magna, Optiwave 980, PERIMOUNT Magna, PERIMOUNT Theon and ThermaFix are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, Carpentier-Edwards, Cosgrove- Edwards, Fogarty, PERIMOUNT, and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the U.S. Patent and Trademark Office. LifeStent is a trademark of Edwards Lifesciences AG and is registered in the U.S. Patent and Trademark Office.
Edwards Lifesciences Corporation
CONTACT: Investor, David K. Erickson, +1-949-250-6826, or Media, Barry R.Liden, +1-949-250-5070, both of Edwards Lifesciences Corporation
