TAVR growth helps Edwards post strong second quarter financial results

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Edwards Lifesciences raised its full-year sales and adjusted earnings per share guidance for 2016 after posting increases in sales and earnings during the quarter that ended June 30.

For the quarter, sales increased 23.1 percent compared with the same period last year to $759.3 million, including a 48.7 percent increase to $418.6 million in the transcatheter heart valve therapy division.

The company’s adjusted earnings increased 33 percent to $0.76 per share, while its GAAP earnings increased 13.7 percent to $0.58 per share.

In the U.S., sales in the transcatheter heart valve therapy division increased 71.5 percent to $246.4 million.

In June 2015, the FDA approved Edwards’ Sapien 3 transcatheter aortic valve replacement (TAVR) device for high-risk patients with severe aortic stenosis.

Edwards CEO Michael A. Mussallem said in a news release that TAVR procedure growth exceeded the company’s expectations. He also said the company had received “consistently positive” feedback from clinicians with regards to an observational study of the Sapien 3 in intermediate-risk patients.

Results of that study were presented at the American College of Cardiology’s scientific session in April. During that trial, patients who received the Sapien 3 had lower rates of death and strokes compared with a group that underwent surgical valve replacement.

For the quarter, Edwards reported a 2.6 percent decrease in sales to $198.7 million in its surgical heart valve therapy division. The company said that it had temporarily suspended production of surgical mitral valves, which affected sales. However, Edwards added that sales of surgical aortic valves increased during the quarter.

Based on its first half results, Edwards said it expects full-year sales to be at the high end of the $2.7 billion to $3.0 billion range it previously reported. The company also expects adjusted earnings per share of between $2.78 and $2.88.

“We are very pleased with our strong performance achieved through the first half of this year,” Mussallem said in a news release. “As patients and clinicians increasingly prefer TAVR, and based on the substantial body of compelling evidence, we remain as optimistic as ever about the long-term growth opportunity represented by transcatheter therapies. Overall, we remain committed to aggressively investing in structural heart disease and critical care technologies. We are confident this will result in more patients being treated with our innovative therapies and continued strong organic growth.”