Abiomed shares dip on Q1 release, despite FDA IDE win

Shares in Abiomed (NSDQ:ABMD) fell today after the medical device maker missed the Street’s expectations for its 2nd quarter, despite touting an FDA IDE win for a trial of its Impella CP heart pump.

The Danvers, Mass.-based company posted profits of $8.9 million, or 21¢ per share, on sales of $103 million for the 3 months ended September 30. That amounts to bottom-line growth of 14.7% on sales growth of 34.8% compared with the same period in 2015.

Earnings per share and revenue were just below consensus on The Street, where analysts expected to see sales of $103 million and earnings per share of 24¢.

“This quarter’s historical achievement with Japanese PMDA approval reflects years of regulatory execution. Additionally, today we are announcing significant new milestones: Impella heart pumps assigned to heart assist system implant, MS-DRG 215 and FDA approval for our feasibility STEMI study, “DTU”, for a new patient population. I am proud of our team’s ability to consistently accomplish our strategic initiatives and execute our tactical plan as Abiomed builds the field of heart recovery,” CEO Michael Minogue said in prepared remarks.

The company said it is maintaining previously released 2017 revenue guidance of $435 to $445 million, with GAAP operating margins between 18 and 20%.

ABMD shares are trading at $100.75 as of 3:09 p.m. EDT, down approximately 9.7%.

The company touted an FDA IDE win, gaining approval for a prospective feasibility study of its Impella CP heart pump for unloading the left ventricle prior to primary percutaneous coronary intervention in patients presenting ST segment elevation myocardial infarction without cardiogenic shock.

“As clinicians and scientists, we appreciate the FDA’s approval of this feasibility study. And we are excited to further investigate whether mechanically reducing the workload of the heart before reopening a blocked coronary artery reduces myocardial damage and the subsequent development of heart failure,” Dr. Navin Kapur said in prepared remarks.

The trial will explore the feasibility and safety of the device, and lay the groundwork for a future trial looking to measure the impact unloading could have on infarct size related to reperfusion injury.

“The majority of patients with large myocardial infarction involving the front wall of the heart develop congestive heart failure within five years. The process of reperfusion with primary PCI should be investigated with new therapeutic strategies targeting myocardial reperfusion injury, which may improve clinical outcomes for patients,” Dr. William O’Neill said in a prepared statement.

Currently, Abiomed’s Impella heart pumps are not approved for use in STEMI patients without cardiogenic shock, the company said. The STEMI patient segment “is contributing to the growing heart failure population and represents a potential new patient indication that may benefit from Impella pump unloading the left ventricle,” the company added.

The prospective, multi-center feasibility study is slated to enroll up to 50 patients at 10 sites with an expected initiation date in the 1st half of 2017, and a length of 18 months. Primary endpoint for the study will be infarct size as a percent of left ventricular mass at 30 days post-PCI.

“Abiomed is committed to investing in innovative research to improve patient outcomes. We believe that reducing heart muscle injury is the key to recovering hearts, avoiding heart failure, improving patient quality of life and reducing health care costs,” CEO Minogue said in a prepared release.

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