Led by strong sales of its Impella devices, Abiomed reported on May 3 that its revenue increased 43 percent to $329.5 million during fiscal year 2016 compared with fiscal year 2015. For the fourth quarter, revenue increased 39 percent to $94.0 million, the 26 th consecutive quarter that Abiomed’s revenue has increased by at least 10 percent year-over-year.
Meanwhile, the gross margin increased to 84.7 percent for the full fiscal year and to 84.4 percent for the fiscal fourth quarter 2016. Abiomed’s GAAP net income was $113.7 million for the year and $98.9 million for the fourth quarter.
Revenue from Abiomed’s Impella heart pumps increased 46 percent to $310.1 million for the year and grew 40 percent to $88.6 million in the fourth quarter. In the U.S., revenue for the Impella devices increased 50 percent to $287.2 million for the year and grew 42 percent to $81.8 million for the fourth quarter. Patient utilization in the U.S. increased 45 percent for the year.
In April, the FDA granted Abiomed premarket approval for the Impella 2.5, CP, 5.0 and LD devices to treat patients with ongoing cardiogenic shock following acute MI or open heart surgery. The Impella is the only FDA-approved, percutaneous hemodynamic support device for this patient population.
“It is important to fully comprehend the magnitude of this recent approval,” Abiomed chairman, CEO and president Michael R. Minogue said in a conference call with analysts. “AMI cardiogenic shock is a growing indication that effects multiple age groups and represents one of the highest mortality risks for patients in the hospital. These patients die of organ failure, when their heart is unable to pump enough blood to the body to sustain life. Clinicians are actively seeking new approaches to effectively treat this severely ill group.”
Minogue said Abiomed representatives would train and educate emergency room physicians, intensivists and heart failure cardiologists on the hemodynamic science of heart recovery and unloading the left ventricle, which could help prevent and/or limit the progression of heart failure. He added that Abiomed would also work with hospitals and physicians on protocols to identify these emergency patients with cardiogenic shock. Minogue also noted that only 5 percent of the estimated 100,000 patients with cardiogenic shock are receiving treatment.
The FDA also granted the Impella RP a humanitarian device exemption approval in January 2015 and granted the Impella 2.5 premarket approval in March 2015 for use during high-risk PCIs. For these patients, many are treated at home or in hospice care and are referred to interventional cardiologists for complete revascularization in the cardiac catheterization laboratory with PCI treatments, according to Minogue. He also said only 5 percent of an estimated 121,000 patients are receiving treatment.
“The multitude of educational tools, outreach programs and training initiatives demonstrating the clinical patient benefits and cost effectiveness has had a direct effect on our growth,” Minogue said. “This is an entirely new, minimally invasive treatment paradigm for the heart failure population.”
As of the end of the fourth fiscal quarter, the Impella 2.5 had been placed at 1,039 of Abiomed’s 1,400 targeted hospital sites. In addition, the Impella CP had been placed at 826 hospitals, the Impella 5.0 had been placed at 408 hospitals and the Impella RP had been placed at 80 sites.
Minogue said Abiomed plans on completing the Impella RP postmarketing study during fiscal year 2017 and submit for an FDA premarket approval in fiscal year 2018.
Abiomed CFO Michael Tomsicek said the company’s investment in manufacturing sites allows Abiomed to produce heart pumps at approximately double its current sales pace. Abiomed also hired 11 employees in the U.S. commercial team, which sells the Impella devices.
During fiscal year 2017, Abiomed plans on hiring 10 employees per quarter for its U.S. commercial team.
“The addition of more clinical and commercially focused staff allows us to go deeper in existing accounts and support the use of Impella for all appropriate PCI and AMI shock patients,” Tomsicek said.
For the fiscal year 2017, Abiomed expects revenue of $430 million to $445 million, an increase of 30 percent to 35 percent over 2016. The company also projects GAAP operating margins of 18 percent to 20 percent for the year.