Edwards Lifesciences (NYSE:EW) CEO Michael Mussallem yesterday said the company believes the FDA could approve its next-generation Sapien 3 transcatheter aortic valve implant this year.
"Based on the strength of the Sapien 3 data presented at [the American College of Cardiology’s annual meeting], the very positive clinician feedback about the valve’s performance and the encouraging discussions with the FDA, we believe it’s becoming more likely that we will obtain U.S. approval of our latest-generation valve this year," Mussallem said during a conference call discussing the Irvine, Calif.-based company’s 1st-quarter results.
Thirty-day results for more nearly 1,600 high- and intermediate-risk patients treated with Sapien 3 "demonstrated the lowest all-cause mortality and stroke rates of any of our Partner studies as well as excellent results on other key metrics. And while this was only 30-day data, the outcomes are encouraging for the future of the therapy and eventual expansion of the approved indication," Mussallem said.
CFO Scott Ullem said a 4th-quarter approval for the Sapien 3 valve is expected to add only about $10 million in sales in the 1st few months.
"If we receive approval in the 4th quarter, we would not expect to see any upward lift from Sapien 3 until 2016," Ullem said.
Edwards more than doubled its profits for the 3 months ended March 31, posting net income of $123.4 million, or $1.12 per share, on sales growth of 13.0% to $590.3 million, compared with the same period last year. Analysts on Wall Street were looking for adjusted earnings of $1.05 per share.
"For the quarter, we experienced strong performance across all product lines and regions, again led by significant growth in transcatheter heart valves sales," Mussallem said in prepared remarks. "Our newest innovative products helped us strengthen our global leadership positions and, most importantly, we believe even more patients with serious needs are benefiting from our technologies than ever before."
Edwards boosted the lower end of its 2015 earnings outlook, saying it now expects to report adjusted EPS of $4.10 to $4.30, compared with prior guidance of $4.00 to $4.30. The company held to its prior full-year sales forecast of $2.3 billion to $2.5 billion. Second-quarter earnings are expected to be between $1.00 and $1.10 on sales of $580 million to $620 million, Edwards said.
EW shares traded down -1.6% to $139.67 apiece today in early activity.
