Shares of Edwards Lifesciences (NYSE:EW) got a little boost on Wall Street after the company posted a 67% spike in Sapien sales during its 1st quarter.
The Irvine, Calif.-based med-tech titan posted $459.2 million in sales during the 3 months ended March 31, a 13.5% increase from he $404.5 million in revenues posted during the same period last year.
"This quarter was highlighted by an impressive 1st full quarter of Sapien commercialization in the U.S.," chairman & CEO Michael Mussallem said in prepared remarks.
"Maintaining a high level of acute procedural success in this new therapy is our first priority, and we are pleased with the high rate that has been achieved," he added.
The news sent EW shares up 4.2% to $76.39 in after-hours trading as of about 6 p.m. today.
Edwards’ 1st quarter profits increased about 2% to $65.1 million, or 55¢ earned per diluted share. Excluding 1-time items, the company posted profits of 53¢ per share, beating Wall Street’s estimates by 5¢.
The company saw growth in most of its business units, including surgical heart valves, cardiac surgery systems and critical care. Only vascular products saw a mild decline of 3.3%.
The big winner, of course, was the transcatheter heart valve unit, which saw a $48.8 million increase, representing a 67.2% leap in sales. The devices won FDA clearance in November 2011 to treat U.S. patients too sick to undergo open-heart surgery, making it the 1st transcatheter aortic valve replacement system commercially available in the U.S.
Rival TAVI maker Medtronic (NYSE:MDT) expects its CoreValve system to hit the U.S. in 2014.
Despite the early results for the newly approved Sapien system, Edwards guided cautiously on transcatheter heart valve sales for the year ahead. The company has a June panel date with the FDA to consider a wider indication for the Sapien system to treat higher-risk patients.
"For 2012, we are lowering the range of our projected overall THV sales by $30 million given an estimated 1 quarter delay in the expected approval of Sapien for high-risk surgical patients in the U.S., current market dynamics in Europe, and the effect of current foreign exchange rates," Mussallem said in a statement. "Although the near term THV sales outlook has lowered our overall 2012 expectations, we remain as optimistic as ever about the long-term growth opportunity represented by transcatheter valves."
"We now expect full year sales at the low end of our original range of $1.95 billion to $2.05 billion, which is approximately 20% underlying growth," Mussallem added. "Excluding special items, we now expect full year 2012 net income growth of approximately 30% and diluted earnings per share of $2.58 to $2.68."
