Edwards Lifesciences reported an increase in quarterly sales of its transcatheter heart valves but lowered its outlook for 2013.
Overall net sales for the quarter increased 8.2 percent, to $496.7 million, compared with the same period last year. Sales of transcatheter heart valves totaled $169.7 million for the quarter, a 39.7 percent growth rate over the first quarter of 2012.
According to Irvine, Calif.-based Edwards, the growth was driven by the ongoing U.S. launch of the Sapient valve used in transcatheter aortic valve replacement (TAVR).
The Sapient valve was approved by the FDA for the treatment of inoperable patients with severe aortic stenosis on Nov. 2, 2011. The agency added approval for the valve to be used in high-risk aortic stenosis patients in October 2012.
The Surgical Heart Valve Therapy product group reported sales of $198.1 million, a 2.7 percent decline from the first quarter of 2012. The Critical Care product group sales were $128.9 million for the quarter, a 3.9 percent decrease from the first quarter last year.
Domestic and international sales for the first quarter were $227.9 million and $268.8 million, respectively.
"The ongoing adoption in the U.S. drove global transcatheter valve [THV] growth of 40 percent," said Michael A. Mussallem, chairman and CEO, in a release. He cited positive clinical results and advances in the product pipeline but also said that global sales in the quarter across product lines were below expectations. “[W]e are lowering our 2013 guidance primarily to reflect a slower start to the year and an updated foreign exchange impact."
He said Edwards now projected 2013 transcatheter valve sales to grow 25 to 30 percent, with expected sales of $670 million to $750 million, of which $350 million to $400 million would be in the U.S. In the fourth quarter of 2012, he had said the expectation was for transcatheter valve sales to grow by up to 45 percent in 2013, with sales up to $790 million globally and $440 million in the U.S.
The company reported a net quarterly income of $144.9 million compared to net income for the same period last year of $65.1 million. The quarter ended March 31.