Abiomed (NSDQ:ABMD) said today that the FDA approved the launch of a trial exploring its Impella CP Heart pump’s ability to treat patients undergoing treatment for a STEMI heart attack, and saw shares drop after releasing fourth quarter and full year fiscal 2019 earnings that missed sales expectations on Wall Street.
The Danvers, Mass.-based company said that it plans to enroll 668 patients under treatment for a STEMI heart attack for its ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) pivotal randomized controlled trial.
“The STEMI DTU Pivotal Trial has the potential to improve the standard of care, slow the growing epidemic of heart failure and improve outcomes for millions of heart attack patients. This trial is the first of its kind to focus on ventricular unloading as part of a therapeutic approach for heart attacks without cardiogenic shock and could lead to a paradigm shift in the way heart attack patients are treated worldwide,” co-principal investigator Dr. Navin Kapur of Tufts Medical Center’s CardioVascular Center for Research and Innovation said in prepared remarks.
In the study, half of the patients will be randomized to receive delayed reperfusion after 30 minutes of left ventricular unloading with the Impella CP, while the other half will receive immediate reperfusion, which is the current standard of care.
Researchers in the study aim to test the hypothesis that unloading the left ventricle for 30 minutes prior to reperfusion reduces myocardial damage from a heart attack and leads to a reduction in future heart failure related events. Abiomed said that myocardial damage can lead to an infarct and that every 5% increase in infarct size is associated with
Abiomed said it plans to begin enrollment in October 29, with an expected end date between 2022 and 2023. At six-months post-enrollment closure, the company plans to submit data to the FDA for a new indication based on primary endpoint and safety data.
The primary endpoint in the trial is infarct size as a percentage of left ventricular mass, measured at 3-5 days using cardiac MRI. Secondary endpoints are a composite of the primary endpoint and cardiogenic shock after 24 hours post-enrollment out to 30 days, cardiovascular mortality at 24 months, heart failure requiring hospitalization at 24 months, ICD and CRT placement at 24 months and others.
Abiomed said it expects the trial will cost approximately $25 million to complete with an additional two-year follow up.
“A successful study will transform the treatment of heart attacks and reduce heart failure for hundreds of thousands of patients each year. As a result, it is important to execute with the highest scientific rigor to ensure a successful study concludes with a Class I recommendation to reach 200,000 U.S. heart attack patients and more than 4 million patients outside the U.S.,” prez & CEO Michael Minogue said in a prepared statement.
For its fourth quarter, Abiomed posted profits of approximately $74 million, or $1.60 per share, on sales of $207.1 million for the three months ended March 31, seeing bottom-line growth of 100.7% while sales grew 18.7% compared with the same period during the previous year.
Earnings per share were well head of the $1.08 consensus on Wall Street, where analysts expected to see sales of $218.9 million, which the company missed.
For the full year, the company posted profits of approximately $259 million, or $5.61 per share, on sales of $769.4 million, seeing the bottom-line grow 130.9% while sales grew 29.6% compared with the previous fiscal year.
Earnings per share were ahead of the $5.08 consensus on Wall Street, where analysts expected to see sales of $780.8 million, which the company topped.
“Q4 did not meet our expectations. I take full responsibility for our disappointing performance given a soft March, and we have already initiated a plan of action to correct the course. However, Abiomed had a solid year with 30% growth and improvement in margins. Most importantly, Abiomed’s clinical support, training, and education helped improve patient outcomes in both high-risk PCI and cardiogenic shock. Multiple publications continue to validate the benefits of Impella supported PCI and Impella best practices to help improve survival in cardiogenic shock. I am confident in our innovation and business today as well as long-term outlook for Abiomed. We are creating the new Field of Heart Recovery,” Minogue said in a press release.
The company provided fiscal year 2020 guidance, expecting to see sales in the range of $900 million to $945 million, reflecting growth of between 17% and 23% over 2019.
The quarter was Abiomed’s “first meaningful sales miss” since the first quarter of its 2015 fiscal year, SVB Leerink partner Danielle Antalffy said in a letter to investors.
The company underperformed in both U.S. and international Impella sales, Antalffy said, missing by approximately 5% for each.
Antalffy said that the company would need to “provide a lot of transparency” in its post-earnings call to explain what happened in March, but gave the company and its leadership credit for having delivered 17 “solid beats” over the last 18 quarters.
Shares in Abiomed are down approximately 2.8% so far today, at $269.33 as of 10:35 a.m. EDT.