Vancouver-based Neovasc posted profits of $865,000, or -10¢ per share, on sales of $28.6 million for the 3 months ended March 31. That amounts to a 900% increase in losses on a -25.4% sales slide, compared with the same period last year.
Neovasc, which won an investigational device exemption from the FDA in October 2014 for the 30 patient Tiara-I feasibility trial, which has enrolled patients at 3 centers in the U.S., Canada and Europe. But the trial isn’t likely to be ready to reveal results at the Transcatheter Cardiovascular Therapeutics conference next fall as expected, Leerink Partners analyst Danielle Antalffy wrote this week.
"To the best of our knowledge, Tiara-I has enrolled 2 patients thus far, 1 in US and 1 OUS," Antalffy wrote. "While it does appear increasingly difficult for NVCN to hit the TCT annual meeting in mid-October for a TIARA-1 data presentation based on current timelines, we do believe the feasibility trial can ramp meaningfully in late 2015 with: (1) Now more centers on board, with management noting the addition of 6 centers, and at least one major center likely to secure regulatory approval in the coming weeks; and (2) More valve sizes, with a 40mm and 45mm possibly available by year-end that will expand the addressable patient population to well over 80% of total mitral regurgitation patients from just ~1/3 of patients addressable today with the currently-available 35mm valve."
The news sent NVCN shares down 4.9% to $7.01 May 12, the day of the earnings release. The stock has dropped another 7.3% to $6.50 per share since then.
CEO Alexei Marko said the company’s top priority this year is "to advance the clinical and regulatory program for Tiara."
"We continue to be encouraged by results to date which support the potential for Tiara as a new therapy for treating this patient population. With patient recruitment now ongoing at centers in Europe, Canada and the United States, we are adding a number of new centers to the trial to facilitate enrollment. We are also accelerating efforts to complete development of 40mm and 45mm sizes of Tiara in order to broaden the eligible patient population from those that can be treated with the current 35mm size. We look forward to continuing to drive this program forwards in order to help address the millions of high risk surgical patients suffering from severe mitral regurgitation," Marko said in prepared remarks.