Edwards Lifesciences Corp.’s fast-growing Sapien replacement heart valve could hit the U.S. in October, the company said last week as part of its first-quarter earnings report.
Sapien doesn’t require major surgery for implantation and already is sold in Europe with expected 2011 sales of about $340 million.
The valve, which is inserted via a catheter, could see U.S. sales of $20 million to $25 million this year, according to Edwards.
“Our anticipated launch of Sapien in the U.S. and its global expansion should position the company for accelerating revenue growth,” Chief Executive Michael Mussallem told investors and analysts on a quarterly conference call last week.
“Domestic launch of Sapien will dominate (Edwards) for the rest of the year,” said Lawrence Neibor, an analyst with Milwaukee-based investment bank Robert W. Baird & Co., in a note to clients.
The October timetable for Sapien suggests growing confidence in obtaining Food and Drug Administration clearance for the device. Up to now, Edwards only had projected a late 2011 U.S. launch.
“We are comfortable with management’s view on the (FDA) approval path for Sapien and think (Edwards) remains on track for an approval,” Paul Choi, a Brooklyn-based analyst with San Diego investment bank Caris & Co., wrote in a report.
Regulators still need to convene a panel on Sapien.
Edwards anticipates having a “panel here over the next few months,” Mussallem said.
The company is forming a U.S. sales and training group for Sapien, the chief executive said.
“We’ve filled most of the key leadership roles and are continuing to add field resources,” Mussallem said.
Sapien’s rollout is set to include training for doctors and clinical teams “to achieve high levels of procedural success from the very start,” he said.
Edwards expects to invest about $40 million to debut Sapien in the U.S.
In the first quarter, Sapien sales in Europe were $72.7 million, up 86% from a year earlier.
Total first-quarter sales for Edwards grew 19% to $404.5 million, above Wall Street’s estimate of $384.5 million.
The company’s first-quarter profit was $63.9 million, up 34% from a year earlier and topping Wall Street’s expectation of $50.6 million.
Expectations for Sapien and rival valves are high since they could open up the market to more patients who aren’t candidates for open heart surgery.
The market for catheter valves could hit $2.3 billion by 2015 with Edwards holding 64% at $1.5 billion, according to analyst Jason Mills of Canaccord Genuity, the investment banking arm of Toronto-based Canaccord Financial Inc.
Early Lead
Edwards is considered to have a lead over rivals, including Medtronic Inc., whose CoreValve was developed in Orange County and also is sold in Europe. CoreValve isn’t expected in the U.S. until mid-decade.
The company also upped its overall 2011 sales projection last week.
Edwards now expects yearly sales of $1.66 billion to $1.74 billion, up from a prior forecast of $1.59 billion to $1.67 billion, according to Mussallem.
New Space
The company’s growth has spurred need for more space. Edwards recently signed a lease for 50,689 square feet of office space at 19520 Jamboree Road in Impac Center, according to real estate sources.
It’s unclear exactly how Edwards plans to use the space. The company is based nearby at McGaw and Red Hill avenues.
