The European debt crisis, a delayed reimbursement decision and summer vacations conspired to reduce expected 3rd-quarter sales for Edwards Lifesciences (NYSE:EW), sending its share price plunging on Wall Street.
The Irvine, Calif.-based medical device company said it now expects Q3 sales of $448 million, down from its prior guidance of $465 million to $485 million for the quarter.
EW shares opened today at $89.56, down 16.6% from yesterday’s close. Shares were trading at $87.17 as of about noon today, down 2.7% on the day and 18.8% from yesterday’s close.
Sales of Edwards’ flagship Sapien transcatheter aortic valve implant are also expected to miss expectations, at $124 million for the 3 months ended Sept. 30.
"In Europe, austerity measures tempered procedural volumes, resulting in underlying1 sales comparable to the same period a year ago. In the U.S., we are pleased with the overall progress of the launch, with training of commercial sites continuing as planned and procedural success rates remaining high," CEO Michael Mussallem said in prepared remarks. "However, under the provisions of the National Coverage Decision (NCD), there was no reimbursement for inoperable patients without femoral access. A clinical protocol that would allow reimbursement for this sizable group of patients was expected earlier; it is now anticipated in the next several weeks. Additionally, due to the requirement that a full heart team be present for every procedure, summer vacations had a more pronounced effect."
Saying he expects a "strong rebound" during the 4th quarter, Mussallem added that an expected FDA approval for an expanded indication for the Sapien valve for high-risk heart disease patients should goose Q4 sales.
"Assuming this FDA approval happens early this quarter, for full-year 2012, we expect to achieve the low end of both our current global [transcatheter heart valve] sales guidance of $550 million to $600 million, and our U.S. THV sales guidance of $240 million to $260 million. We remain enthusiastic about the potential of this transformative technology to improve the lives of many of the patients who suffer from severe aortic stenosis," he said.
