Boston Scientific confirms Lotus valve off the market until 2019

Boston Scientific (NYSE:BSX) CEO Mike Mahoney yesterday confirmed that the company’s entry into the transcatheter aortic valve market, Lotus, will remain off the market for the rest of the year.

Last November news of another Lotus delay pared  $3 billion from Boston’s market capitalization. The Marlborough, Mass.-based company, which recalled the Lotus transcatheter aortic heart valve in February 2017 over issues with its locking mechanism, said it no longer expected the ensuing manufacturing and design specification changes to get the valve back on the market in Europe or allow the final filing in its pre-market approval bid with the FDA by January 2018.

During a conference call yesterday to discuss the company’s fourth-quarter and 2017 results, Mahoney said that, “pending our ability to clear certain technical and regulatory hurdles,” the goal is to get the Lotus TAVR on shelves in Europe and the U.S. in 2019.

“Leveraging that will be helpful because we have a certain amount of commercial infrastructure that’s in place, ready to go there,” CFO Daniel Brennan added, according to a Seeking Alpha transcript.

Boston paused Lotus implantations in October 2016 to investigate a locking mechanism issue but even though that problem was solved by January 2017, the next month the company voluntarily pulled all Lotus devices from global commercial and clinical sites “due to reports of premature release of a pin connecting the Lotus valve to the delivery system.”

By last November Boston had said it no longer expected the ensuing manufacturing and design specification changes to get the valve back on the market in Europe or allow the final filing in its pre-market approval bid with the FDA by January 2018.

Yesterday the company reported that an estimated $861 million tax charge pushed it into the red during the fourth quarter and slashed full-year profits by 70%, but the results still managed to meet or beat Wall Street’s expectations.

Boston Scientific posted losses of -$615 million, or -45¢ per share, on sales of $2.41 billion for the three months ended Dec. 31, 2017, compared with Q4 profits of $124 million, or 9¢ per share on sales growth of 9.9%. Adjusted to exclude one-time items including the tax sting, earnings per share were 34¢, dead in line with The Street, where analysts were looking for sales of $2.38 billion.

Full-year profits were $104 million, or 8¢ per share, on sales of $9.05 billion, for a -70.0% bottom-line slide on sales growth of 7.9% compared with 2016. Adjusted EPS came in at $1.26, again even with analysts, who forecast sales of $9.01 billion.

BSX shares closed down -1.2% at $27.63 apiece yesterday.

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