Shares in Abiomed (NSDQ:ABMD) fell nearly 13% this morning after the company issued revenue guidance that missed Wall Street expectations.
The Danvers, Mass.-based company said in an SEC filing that it expects sales of $221.6 million for the third quarter of its fiscal 2020 year, which ended Dec. 31, 2019. While that figure is 10% higher than Q3 2018 revenues, it fell below the analyst consensus of $226.6 million.
Abiomed is forecasting full-year FY 2020 revenue of $846 million to $877 million, which would put it 10% to 14% ahead of the previous fiscal year, but below analysts’ consensus of $885.8 million.
Shares of ABMD took a 20% hit Nov. 18 after new research suggested potentially serious complications involving the company’s Impella heart pumps. Abiomed maintains that the research was flawed and said today that it is taking steps to increase the publications of real-world evidence for mechanical circulatory support. The company also said it is:
- Creating a dedicated faculty of circulatory support physician experts to conduct education and training on PCI and hemodynamic support.
- Starting a multi-city road show in Q4 to review with physicians Impella’s current clinical data, FDA studies and best practices that support Impella’s indications for high-risk PCI, cardiogenic shock and right heart failure.
- Working with medical societies and hospitals “to communicate the audited and published results from seven FDA studies, five on-going FDA post-approval studies, and independent physician-led initiates such as NCSI, the INOVA heart team approach, and The Shock Working Group. These studies demonstrate improved outcomes with our best practices for high-risk PCI, cardiogenic shock and right heart failure,” the company said.
Abiomed also cited data that reveal lower or comparable event rates for stroke, vascular complications and major bleeding with Impella as compared to IABP and ECMO.
“Abiomed remains focused on our goal of creating the new field of heart recovery and becoming the standard of care for circulatory support. This is an ambitious goal that certainly has challenges with the diffusion of any new break-through innovation, and we are taking specific actions to address these challenges. The long-term outlook for Abiomed remains intact and we are working with physician experts to clarify and educate the community on Impella best practice protocols and clinical outcomes,” said company president & CEO Michael Minogue. “Our product innovation has never been better with the launch of Impella CP and Impella 5.5 with SmartAssist. We have our best-ever clinical outcomes with our protocols for high-risk PCI, cardiogenic shock and right heart failure.”
Abiomed won clearance for the Impella RP in September of 2017, and it remains the only device with FDA premarket approval for right-side heart support. Much like the company’s flagship Impella heart pump, the Impella RP is threaded into the heart via the femoral artery in the thigh. But unlike previous Impella models, all designed for the heart’s left ventricle, the Impella RP is designed to access the heart’s right ventricle via the vena cava.
The next post-approval study report on Impella RP is due March 20, 2020. The FDA said it will continue to post interim results from the ongoing study on the post-approval studies webpage.
