SOURCE: Edwards Lifesciences

Edwards Lifesciences

December 09, 2011 08:30 ET

Edwards Lifesciences Forecasts Strong Sales and Earnings Growth in 2012

U.S. THV Launch Fuels Projected 18 to 22 Percent Underlying Sales Growth; Two New Transcatheter Heart Valve Platforms Debuted; Reaffirms Guidance for 2011

NEW YORK, NY--(Marketwire - Dec 9, 2011) - 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 strong double-digit sales and earnings growth in 2012. 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 2012.

"We expect 2012 will be a transformational year for Edwards Lifesciences as we deliver new life saving technologies to patients around the world," said Michael A. Mussallem, chairman and CEO. "We are investing aggressively to drive breakthrough innovations in heart valve treatment and to build on our legacy as a trusted partner for managing the critically ill.

"We project underlying(i) sales growth of 18 to 22 percent fueled by the launch of our SAPIEN transcatheter heart valve, recently made available to U.S. patients. Sales of our market-expanding transcatheter valves are expected to grow to between $560 million and $630 million in 2012."

During the conference, Edwards' management will also present the company's financial goals for 2012, which include total sales between $1.95 billion and $2.05 billion, a gross profit margin of 73 to 75 percent, net income growth of 35 to 40 percent, excluding special items, and free cash flow of $240 million to $260 million, excluding special items(ii). "Our financial strength and global leadership should enable us to increase our investment in research and development by approximately 14 percent. These investments position us well to serve many more patients with our innovative technologies and generate significant growth for years to come," said Mussallem.

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

  • Transcatheter Heart Valves - A number of substantial developments are expected during 2012 in both the commercial and clinical trial settings. The U.S. commercial launch of the Edwards SAPIEN transcatheter valve is proceeding on schedule, driven by strong interest among clinicians and patients. Transcatheter valve sales in the U.S. for 2012 are projected to be $200 million to $260 million, which are expected to contribute to a global transcatheter underlying sales growth rate of 70 to 90 percent. The company continues to expect U.S. approval of SAPIEN (Cohort A) for high-risk patients in mid-2012.

    The PARTNER II Trial, which is studying the Edwards SAPIEN XT transcatheter valve in an expanded patient population, is currently underway in the U.S. The company now anticipates enrollment in Cohort B of this trial to be completed in January 2012, and continues to expect U.S. regulatory approval in 2014. Enrollment also has begun in PARTNER II Cohort A, which is studying patients with a lower risk profile than those who were enrolled in The PARTNER Trial.

    Edwards will also unveil two new transcatheter valve platforms designed to extend its leadership position in this rapidly growing field. The Edwards SAPIEN 3 is a lower profile balloon expandable valve designed to further reduce paravalvular leak. The Edwards CENTERA valve is a low profile, repositionable self-expanding valve with a motorized delivery system for stable deployment and single operator use. These two platforms are designed to facilitate multiple interventional and surgical delivery approaches. European clinical trials for both of these new products, which are delivered through 14-French eSheath delivery systems, are expected to commence in 2012.

  • Surgical Heart Valve Therapy - Edwards is making substantial investments in new surgical valve technologies designed to extend its leadership and improve patient recovery and outcomes. The innovative EDWARDS INTUITY valve system, which has been clinically evaluated, expands minimally invasive options for patients. During 2012, the company will conduct a commercial registry and economic analysis in order to reinforce the favorable performance and procedural success rates reported thus far.

    Edwards will also unveil GLX, a next-generation tissue technology designed to reduce calcification, enable a smaller valve profile and improve ease of use. European regulatory approval for GLX is expected in 2012.

    Together with sales of Cardiac Surgery Systems products, Edwards expects to generate Surgical Heart Valve Therapy sales of $800 million to $830 million, representing a 3 to 5 percent underlying growth rate.

  • Critical Care - Building upon its global leadership in hemodynamic monitoring systems, Edwards expects sustained growth across this product line driven primarily by the company's advanced monitoring technologies. In addition, the company continues to project share gains in its legacy products in both established and emerging markets. And, Edwards continues to focus on the ease of use of its GlucoClear hospital glucose monitoring system and expects a second half 2012 CE Mark in Europe. Together with sales of Vascular products, Critical Care sales are expected to be $580 million to $610 million, representing 5 to 8 percent underlying growth.

  • Financial Outlook - Edwards will reaffirm its 2011 guidance, which includes earnings per share of $1.97 to $2.02, excluding special items. The company will also detail its expectations for 2012. Excluding special items, Edwards expects 2012 earnings per share of $2.70 to $2.80.

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;
Carlyn D. Solomon, corporate vice president, Critical Care; and
Larry L. Wood, corporate vice president, Transcatheter Valve Replacement.

Guest Speakers to Provide Clinical Perspective
Also speaking at the conference are interventional cardiologist Dr. David J. Cohen, Director of Cardiovascular Research at the Mid-America Heart Institute and Professor of Medicine at the University of Missouri-Kansas City, Missouri, and cardiothoracic surgeon Dr. Gregory P. Fontana, Chairman, Department of Cardiothoracic Surgery at North Shore LIJ Health System/Lenox Hill Hospital, New York, who will discuss their perspectives on heart valve therapies.

Webcast Information
The Edwards Lifesciences 2011 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 9, 2011. 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, Mr. Mussallem's statements; the Company's 2011 and 2012 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, R&D expense, free cash flow and other financial expectations; expectations regarding new transcatheter valve platforms; strategies for long-term growth; and expectations regarding the development and introduction of new products, indications and technologies (including clinical trials, regulatory approvals, and market opportunities) and market share gains. 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 unexpected changes or developments in 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, and creating new market opportunities for its products; quality or manufacturing issues; 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, 2010.

To supplement the consolidated financial results prepared in accordance with Generally Accepted Accounting Principles ("GAAP"), the Company uses non-GAAP financial measures. The Company uses the term "underlying" when referring to non-GAAP sales information, which excludes discontinued and acquired products and foreign exchange fluctuations, and "excluding special items" to also exclude gains and losses from special items such as significant investments, litigation, and business development transactions. Guidance for sales and sales growth rates is provided on an "underlying" basis, and projections for diluted earnings per share, gross profit margin, net income and growth, and free cash flow are also provided on the same non-GAAP (or "excluding special items") basis due to the inherent difficulty in forecasting such items. Management does not consider the excluded items part of day-to-day business or reflective of the core operational activities of the Company as they result from transactions outside the ordinary course of business. Management uses non-GAAP financial measures internally for strategic decision making, forecasting future results and evaluating current performance. By disclosing non-GAAP financial measures, management intends to provide investors with a more meaningful, consistent comparison of the Company's core operating results and trends for the periods presented. These non-GAAP financial measures are used in addition to and in conjunction with results presented in accordance with GAAP and reflect an additional way of viewing aspects of the company's operations that, when viewed with its GAAP results, provide a more complete understanding of factors and trends affecting the company's business. These non-GAAP measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with generally accepted accounting principles. Non-GAAP financial measures are not prepared in accordance with GAAP; therefore, the information is not necessarily comparable to other companies. The Company is not able to provide a reconciliation of underlying sales and sales growth or projected gross profit margin, net income and growth, projected earnings per share guidance and projected free cash flow, excluding special items, to expected reported results due to the unknown effect, timing and potential significance of special charges or gains, and management's inability to forecast foreign currency changes and charges associated with future transactions and initiatives.

Edwards, Edwards Lifesciences, the stylized E logo, Edwards CENTERA, Edwards INTUITY, Edwards SAPIEN, Edwards SAPIEN XT, SAPIEN, eSHEATH, GlucoClear, GLX, PARTNER and PARTNER II are trademarks of Edwards Lifesciences Corporation.

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

(ii) 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:
    Sarah Huoh
    949-250-5070

    Edwards Lifesciences Corporation
    One Edwards Way Irvine, CA USA 92614
    Phone: 949.250.2500 Fax: 949.250.2525
    www.edwards.com