Expanded use for Edwards' Sapien heart valve faces FDA delay

The good news: Edwards Life Sciences' ($EW) Sapien transcatheter heart valve pulled in $41 million in sales during the company's fiscal 2012 first quarter. It's the first full quarter the device has been on the market since gaining FDA approval in November.

The bad news: the FDA may take at least another quarter to decide whether it will expand Sapien's indication to a larger class of patients.

Sapien's debut sales quarter is noteworthy for a new product designed to improve the standard of care. As a result, Edwards' overall sales of transcatheter heart valves soared to $121.5 million during the quarter, up by more than 67%. But in announcing its first-quarter earnings, Edwards lowered projected 2012 sales for the line by $30 million to between $530 million and $600 million--$200 million to $240 million in the U.S.-- because it expects to have to wait an extra quarter for the FDA to approve an expanded indication for Sapien. (European market dynamics and foreign exchanges rates didn't help, either.)

Investors still liked the news, driving Edwards' stock more than 7.5% higher to $78.97 in early trading April 25. RBC Capital Markets analyst Glenn Novarro said Sapien's sales started off slow and built momentum through the quarter because "physicians and hospitals are embracing the technology," according to Bloomberg.

Right now, Sapien is allowed commercially in the U.S. for patients with limited classes of stenosis who also can't have surgery. Edwards will be taking Sapien before an FDA panel of experts June 13, with a goal of expanding its use for patients with severe, symptomatic aortic stenosis who are at high risk for surgery.

Overall, the company booked $459.2 million in net sales during the quarter, up 13.5% from the $404.5 million a year earlier. The company's surgical heart valve therapy group generated $203.6 million in sales, up 2.7%; critical care sales only jumped slightly, increasing to $134.1 million, up just under 1% from a year ago, driven by advanced monitoring product sales in Europe and the U.S. Overall net income reached just over $65 million, or 55 cents per diluted share, up 3.8% over last year. That beat analyst estimates of about 48 cents per share, Bloomberg said.

(Image of the Sapien transcatheter heart valve courtesy of Edwards Lifesciences)

- read the Bloomberg story
- check out the earnings release