Edwards Lifesciences slides on weak 3Q outlook

IRVINE, Calif. -- Edwards Lifesciences Corp. shares fell nearly 16 percent in after-hours trading Monday following a disappointing third-quarter revenue forecast Monday, including weak sales of its Sapien heart valve.

Edwards said government austerity measures hurt its revenue from Europe while U.S. sales are constrained by Medicare coverage issues. It said a decision on broader Medicare reimbursement could come in the next few weeks. The company added that its revenue was also affected by staffing issues, like summer vacations, because full heart surgical teams are required to be present for all Sapien procedures.

The company said its total revenue rose 9 percent to $448 million, well short of its initial forecast of $465 million to $485 million. It said sales of Sapien heart valves totaled about $124 million, including $55 million in U.S. revenue. Both totals fell short of company expectations.

Analysts expected Edwards to report $476.5 million in revenue, according to FactSet.

The Sapien valve is designed to replace diseased aortic valves. The Food and Drug Administration approved the Sapien valve in November, and Medicare agreed to cover Sapien surgical procedures in May. An FDA panel suggested broader marketing approval for Sapien in June.

Edwards anticipates better results in the fourth quarter. The company has forecast $550 million to $600 million in Sapien revenue in 2012, including $240 million to $260 million in the U.S. It said Monday that it will reach the low end of those ranges.

Shares of Edwards Lifesciences skidded $16.67, or 15.5 percent, to $90.74 in aftermarket trading.