Edwards Lifesciences, an Irvine, Calif.-based manufacturer of cardiovascular devices and critical-care monitoring equipment, reported an increase in first-quarter earnings driven by strong sales of its transcatheter aortic valve replacement device.
The positive numbers come after Sapien 3, the company's latest transcatheter valve, was shown to be superior to surgery in intermediate-risk patients, according to study results presented at the American College of Cardiology Conference earlier this month. The Sapien 3 is approved for use only in patients who would otherwise be at high-risk for open-heart surgery.
The company now expects its 2016 sales to reach between $2.7 billion and $3 billion, thanks in part to the earlier-than-expected expansion of approved indications for use of Sapien 3.
CEO Michael Mussallem said the company remains on track to submit final intermediate-risk data sets to the FDA and is expecting a launch of Sapien 3 to the intermediate-risk market in the fourth quarter.
“We think (transcatheter valve replacement) is a $5 billion opportunity in just a few years,” Mussallem said. “There's more and more evidence to believe that's real, and we're on a pathway to clearly get intermediate risk and just a few years out think we'll be successful for a low-risk trial.”
Edwards reported $143 million in profit during the first quarter, up 16% from the same period the year before. The company reported $697.3 million in quarterly sales, up 18% from last year.
Worldwide sales of transcatheter heart valve therapies were $367.8 million, up 37% as more U.S. hospitals adopted the technology but also thanks to the Sapien 3 launch, according to Edwards. Nearly 60% of the company's transcatheter valve therapy sales are in the U.S.
Surgical heart valve therapy sales were down 0.5% at $195.9 million. The discontinuation of “nonstrategic” cannula products—tubes that are used to remove fluid—offset increased sales of surgical heart valve units.
Sales of critical-care products increased 7% year over year to $133.6 million.
Edwards invested almost 19% more in research and development in the first quarter of this year than in 2015.