Transcatheter heart valves sales bolster Edwards FY11

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Edwards Lifesciences, a developer of heart valves and hemodynamic monitoring, has reported an increase in net income in the fiscal year of 2011, compared with 2010, and a slight decrease in net income for the 2011 fourth quarter over the previous year's fourth quarter.

For the 2011 fiscal year, the company booked a net income of $236.7 million, compared with $218 million for the same period in 2010. Net income growth for the year was 8.6 percent. The net sales for the 12 months of 2011 increased 16 percent to $1.68 billion.

The Irvine, Calif.-based company recorded a net income for the fourth quarter, ending Dec. 31, 2011, of $63.1 million, compared with a net income of $64.8 million for the same period in 2010. Also, the fourth quarter net sales increased 9.6 percent to $430.2 million compared with the same period last year.

For the 2011 fourth quarter, the company reported heart valve therapy sales of $256.6 million, representing 13.4 percent growth over last year. Underlying sales grew 12.5 percent. Transcatheter heart valve (THV) sales were $93.2 million, a 42.7 percent increase over 2010. Also, the total THV commercial and clinical sales in the U.S. were $17.1 million. 

"We continue to project full year 2012 THV sales of $560 to $630 million, including $200 to $260 million of sales in the U.S., which translates to a 70 to 90 percent underlying sales growth rate," Michael A. Mussallem, chairman and CEO, said in a statement.

Surgical heart valve sales were $163.4 million this quarter, a 1.6 percent increase over 2010 last year. Outside the U.S., sales grew 7.2 percent, driven primarily by sales of premium products in Asia. In the U.S., sales declined this quarter “due to the 2011 introduction of a competitor's product, combined with estimated flat procedural volumes,” according to Edwards.

Critical care sales were $133.3 million for the quarter, representing 4.5 percent growth over last year. Driving the growth this quarter were sales of advanced monitoring products, including EV1000 monitoring hardware and FloTrac. 

Cardiac surgery systems sales increased to $27.2 million for the quarter, representing 8 percent growth over the 2010 fourth quarter. Vascular sales were $13.1 million, down slightly from the same quarter in 2010.

Domestic and international sales for the 2011 fourth quarter were $154.7 million and $275.5 million, respectively.

Selling, general and administrative expenses were $163.4 million for the quarter, or 38 percent of sales, compared with $142.4 million in the prior year. This 14.7 percent increase was driven primarily by U.S. transcatheter launch-related investments.

Research and development expenses for the fourth quarter grew 8.6 percent to $60.7 million, or 14.1 percent of sales. This increase was primarily the result of additional investments in the company's transcatheter valve programs.

Domestic and international sales for the 12 months were $605.6 million and $1.07 billion, respectively.

“For the first quarter of 2012, we project total sales of $440 to $460 million and continue to expect full year sales of $1.95 to $2.05 billion," Mussallem added.