The Danvers, Mass.-based company reported profits of $69.2 million, or $1.51 per share, on sales of $221.6 million for the three months ended Dec. 31, 2019, for a bottom-line gain of 54.3% sales growth of 10.5% compared with Q3 2019.
Earnings per share were $1.51, 42¢ ahead of The Street, where analysts were looking for sales of $227 million.
“Abiomed remains steadfast on our goal of creating the new field of heart recovery and becoming the standard of care for circulatory support for high-risk PCI and cardiogenic shock,” president and CEO Michael Minogue said in a news release.
“Today, we are announcing the start of the next wave of clinical studies designed by the true experts in the field with the best practice protocols derived from 15 years of clinical experience and studies. In the history of the company, I feel most confident now about the strength of our innovation, clinical outcomes with protocols and field teams. We will remember this time and recognize the opportunity to propel us forward on our path for Class I guidelines for percutaneous unloading heart pumps called Impella,” Minogue said.
The company in a press release said it was negatively impacted by two critical studies that suggested potentially serious complications involving its Impella heart pumps in November last year.
“The Circulation publication is misleading because the authors manipulated a subset of 4% of our patients over a 10-year observational database and did not disclose the analytical methods to other researchers and waived the Institutional Review Board because the study was determined to not be ‘human subjects research,'” Minogue said during an earnings call. “Both the publication and the other presentation from nearly the same authors contain factual inaccuracies that demonstrate a lack of knowledge of the totality of the Impella data and FDA regulatory process. The Circulation paper and NCDR presentation, both excluded the sickest IAB patients who were escalated to other therapies and all ECMO patients which is the treatment most utilized at the authors’ hospitals.”
The company revised its 2020 revenue guideline to be in the range of $846 million to $877 million and maintains its GAAP operating making guidance for the fiscal year 2020.
Shares in ABMD were down -7.89% to $175.69 apiece in early morning trading.