Abiomed touts CE Mark for Impella Connect, posts Street-beating FY2019 Q3 earnings

Abiomed (NSDQ:ABMD) said today that it won CE Mark approval in the European Union for its Impella Connect cloud-based Impella heart pump console and released fiscal year 2019 third quarter earnings that topped expectations on Wall Street.

The Danvers, Mass.-based company said its Impella Connect is a cloud-based platform that allows physicians and hospital staff to view the Impella console remotely, as long as they have an internet connection.

“Impella Connect is an extremely valuable resource that allows me, as well as allied health professionals and nursing staff, to have direct visualization of data from the Impella console and to closely monitor patients on hemodynamic support, in real time,” Dr. Rajeev Narayan of the Vassar Brothers Medical Center said in a prepared statement.

The system has already won FDA premarket approval, and is in a limited market release in the US, Abiomed said, with 36 hospital sites already using the technology. The first European center slated to use the technology is Hamburg, Germany’s University Heart Center.

“Impella Connect is a technological advancement which represents the next frontier of heart recovery products. Impella Connect, along with our 24×7 onsite and on-call support, enables physicians, nurses and ICU staff to increase productivity, improve patient outcomes, and help patients return home with their native heart,” prez & CEO Michael Minogue said in prepared remarks.

In its earnings release, Abiomed posted profits of approximately $44.9 million, or 97¢ per share, on sales of approximately $200.6 million for the three months ended December 31, for massive bottom-line growth of 233.6% while sales grew 30.2% compared with the same period during the previous year.

Earnings per share were just ahead of the 94¢ consensus on Wall Street, where analysts expected to see sales of approximately $196 million, which the company also topped.

“We are proud of our 100,000th patient milestone and we will continue to grow the field of heart recovery and improve patient outcomes by partnering with our customers to use real-world data to identify and validate best practices and protocols. We remain focused on disciplined execution and sustainable growth so that even more patients around the world can benefit from heart recovery,” prez & CEO Michael Minogue said in a press release.

The company lifted its full fiscal year 2019 financial guidance, expecting to post sales of $780 million, up from previous guidance of between $765 million and $770 million.

Abiomed added that it also updated its GAAP operating margin expectations from between 28% and 30% to between 29% and 29.5%.

Shares in Abiomed have risen 6.4% so far today, at $361.35 as of 11:26 a.m. EST.

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