Edwards Lifesciences (EW) to Outline FY12 Outlook; Guides EPS, Revs In-Line

Edwards Lifesciences Corporation (NYSE: EW), 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.

From the release:

"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). The Street sees sales of $2.01 billion.

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 Street is at $2.00). The company will also detail its expectations for 2012. Excluding special items, Edwards expects 2012 earnings per share of $2.70 to $2.80, versus the consensus of $2.78.

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