Abiomed (NSDQ:ABMD) shares are up sharply this morning on news of an agreement with the FDA on the indication for its Impella 2.5 heart pump, which the company now expects to win pre-market approval in early 2015 without an appearance before an FDA advisory panel.
The federal watchdog agency’s Circulatory Devices panel recommended in late 2012 that devices like Abiomed’s flagship Impella 2.5 device be subject to the FDA’s most stringent PMA protocol. The pump had been allowed on the U.S. market via the FDA’s less-stringent 510(k) clearance protocol.
In July Abiomed said it expected to win PMA approval in March 2015, but today the Danvers, Mass.-based medical device company said it reached an agreement with the FDA on the indication for the Impella 2.5 and now believes the agency will grant approval without another Circulatory Devices panel meeting by February or March next year.
The news sent ABMD shares up 16.5% to $29.73 apiece as of about 10 a.m. Eastern this morning, close to their 52-week high of $30.77.
Abiomed also reported fiscal 2nd-quarter results that beat sales expectations and profit growth of nearly 263%, compared with the same period last year. Profits for the 3 months ended Sept. 30 were $3.8 million, or 9¢ per share, on sales of $51.9 million, for a top-line increase of 17.1%.
"Abiomed achieved the highest quarterly revenue to date at $51.9 million, and has now grown top-line revenue by double digits, year over year, for 20 straight quarters," chairman, president & CEO Michael Minogue said in prepared remarks. "Abiomed’s investment in clinical research, new products and patent portfolio, along with our disciplined approach in execution continue to provide Abiomed the opportunity to become the new standard of care and recognized leader in percutaneous circulatory support."
The company boosted the lower end of its sales guidance for fiscal 2015, to $209 million to $212 million from prior guidance of $205 million to $212 million, and reiterated its expectation for operating margins of 1% to 4%.
Leerink Partners analyst Danielle Antalffy said the indication for high-risk percutaneous coronary intervention patients is "the best-case scenario," in that it includes emergent shock patients who make up about 44% of Impella patients. High-risk patients account for another roughly 44%, Antalffy wrote this morning in a note to investors.
Abiomed said it will file for PMA supplements for its Impella 5.0 and Impella CP devices once the Impella 2.5 wins its PMA.