Edwards Lifesciences Corp. said Wednesday its third-quarter profit grew 8 percent, but the company trimmed its guidance for the full year because of a delay in regulatory approval for a new product.
Edwards' net income increased to $51.6 million, or 43 cents per share, from $48 million, or 40 cents per share, one year ago. The company said it earned 38 cents per share excluding one-time costs and benefits. Revenue rose 18 percent to $412.7 million from $348.9 million.
Analysts expected the company to report a profit of 39 cents per share on revenue of $404.3 million, according to estimates compiled by FactSet.
Edwards said revenue from its heart valve therapy business rose 23 percent to $246.1 million. That included a 69 percent jump in revenue from its transcatheter heart valve business, which brought it $82.6 million in revenue. Surgical heart valve revenue rose 8 percent to $163.5 million.
Critical care revenue rose 14 percent to $126.7 million. Cardiac surgery system sales rose 13 percent to $26.9 million and vascular revenue edged down to $13 million.
Edwards is waiting for a decision from the Food and Drug Administration on its Sapien heart valve, which is designed to replace diseased valves. Sapien can be threaded into place through one of the body's major arteries, which would make it an option for patients who are too sick to have open heart surgery. The agency is due to make a decision in October, but on Monday, an FDA panelist said the valve won't be approved until April.
The company said it expects $20 million to $25 million in sales of Sapien in the first three months after it is approved, and $150 million to $250 million in sales in the first 12 months.
Edwards said it now expects to earn between $1.97 and $2.02 per share for 2011, down from its previous estimate of $2.01 to $2.07 per share. It narrowed its revenue forecast to a range of $1.68 billion to $1.72 billion, from $1.66 billion to $1.74 billion. The company said its profit in the fourth quarter will be between 57 and 62 cents per share, but acknowledged that delay in the approval of Sapien would affect its results.
Analysts expect Edwards to report a full-year profit of $2.04 per share and $1.7 billion in revenue, and they expect income of 62 cents per share in the fourth quarter.
Edwards shares lost $2.37, or 3.4 percent, to $67.79 on Wednesday. The stock was unchanged in aftermarket trading.