|Edwards Lifesciences' shares fell nearly 10% despite growth in sales of its Sapien valve.--Courtesy of Edwards Lifesciences|
Edwards Lifesciences ($EW) remains atop the synthetic heart valve scrum, but the company's tepid growth projections have alarmed investors, and Edwards' shares fell almost 10% on Tuesday as it again forecast earnings below expectations.
The third quarter's $496 million is an 11% jump over the same period last year, but U.S. sales of Edwards' banner Sapien valve have been slower than expected since the device's stateside launch, and European sales have changed little this year despite Edwards winning a German injunction over Medtronic ($MDT) and its rival CoreValve.
Now, with Boston Scientific ($BSX) about to make European landfall with its Lotus implant and Medtronic inching toward FDA approval for CoreValve, Edwards is under the gun to make the most of what could be its waning days of transcatheter aortic valve dominance.
The company is still expecting up to $2.1 billion in revenue on the year, and Edwards set its fourth-quarter earnings-per-share guidance at between 81 cents and 85 cents, but those figures apparently weren't enough to satisfy investors, and Edwards' shares fell nearly 10% to $72.21 overnight, settling at around $73 by midmorning Tuesday.
Unimpressive goals and investor malaise are nothing new for Edwards, which watched its shares tank about 20% back in April when it slashed its full-year sales projections by about 5% "to reflect a slower start to the year," CEO Michael Mussallem said. That move set off alarms among analysts and investors, and Edwards has had its every move scrutinized ever since.
Still, the California devicemaker charted some victories in the third quarter, securing an expanded FDA approval for its first-generation Sapien, winning the agency's blessing to start studying the Sapien 3 in the U.S., beating out Medtronic in German court and locking down Japanese reimbursement for the Sapien XT.
Now, of course, it's up to Edwards to translate those milestones into an impressive sales performance.
- read Edwards' results