Abiomed announces Q2 FY 2021 revenue of $210M

Abiomed, Inc., a leading provider of breakthrough heart support technologies today reported second quarter fiscal 2021 revenue of $209.8 million, a sequential increase of 27% compared to Q1 fiscal year 2021 and a year over year increase of 2% compared to Q2 fiscal year 2020 despite the negative impact of COVID-19. Operating income was $61.3 million up 2%, compared to $60.2 million in the same period of fiscal 2020.

Recent financial and operating highlights include:

• Worldwide Impella heart pump revenue for the quarter totaled $199.7 million, a sequential increase of 29% compared to revenue of $155.4 million during Q1 fiscal year 2021 and a 1% increase compared to revenue of $196.9 million during Q2 fiscal year 2020.

• U.S. Impella product revenue for the quarter totaled $163.2 million, a sequential increase of 29% compared to revenue of $126.2 million during Q1 fiscal year 2021 and a decrease of 1% compared to revenue of $164.7 million during Q2 fiscal year 2020 with U.S. patient usage of the Impella heart pumps up 24% over prior fiscal quarter and down 4% over prior fiscal year.

• Outside the U.S., Impella product revenue for the quarter totaled $36.5 million, a sequential increase of 25% compared to revenue of $29.2 million during Q1 fiscal year 2021 and an increase of 13% compared to revenue of $32.2 million during Q2 fiscal year 2020. European Impella product revenue increased 29% compared to the prior fiscal quarter and 16% compared to the prior fiscal year. Japan Impella product revenue increased 14% compared to the prior fiscal quarter and 5% compared to the prior fiscal year.

• Gross margin for the second quarter fiscal 2021 was 81.5% compared to 83.0% during the same period of fiscal 2020.

• Operating income for the second quarter fiscal 2021 was $61.3 million, or 29.2% operating margin, compared to $60.2 million, or 29.4% operating margin in the same period of fiscal 2020.

• Second quarter fiscal 2021 GAAP net income was $62.2 million, or $1.36 per diluted share, which includes a $8.2 million, or $0.18 per diluted share, gain on our investment in Shockwave and a $7.9 million, or $0.17 per diluted share, of excess tax benefits related to employee share-based compensation awards. This compared to GAAP net income of $13.1 million or $0.28 per diluted share for the prior fiscal year.

• The company generated operating cash flow of $77.2 million in the second quarter. As of September 30, 2020, the company had $735.7 million of cash and marketable securities and no debt.

• At the end of second quarter fiscal 2021, Abiomed has 929 patents and 835 patents pending due to our continued innovation and expanding our global reach.

• In October, at TCT Connect, more than 20 presentations and abstracts were presented validating the benefits of a more complete revascularization with Impella heart pumps in high-risk percutaneous coronary intervention (PCI) patients and the value of Impella protocol-based treatment for survival and native heart recovery in cardiogenic shock and right heart failure patients. Key data presented includes:
  • New PROTECT III study data demonstrates reduced rates of MACCE (composite of death, stroke, myocardial infarction and repeat procedures) compared to the Protect II dataset (15% vs. 21.9%, p=0.035).
  • The Restore EF Study demonstrates the use of contemporary best practices with Impella-supported high-risk PCI enables a more complete revascularization and is associated with significant improvement of left ventricular ejection fraction (45% relative improvement), heart failure symptoms (80% reduction in NYHA Class III, IV), and anginal symptoms at follow up (99% reduction in CCS Angina Class III, IV).
  • Data from the RECOVER III post-market approval (PMA) study of AMI cardiogenic shock (AMICS) patients was presented in two studies. The first study, presented by Hemindermeet Singh, MD, of Ascension St. John Hospital, found an 18% relative improvement in overall survival in the recent cohort (2017 – 2019) versus a pre-PMA cohort (2008 – 2014), indicating increased adoption of the cardiogenic shock best practices, including placing Impella pre-PCI has led to an improvement in overall survival rates. The second study, presented by Tayyab Shah, MD, of the Yale School of Medicine, found that placing Impella pre-PCI in AMICS patients is associated with higher survival, particularly in women, as compared to post-PCI (74% relative survival benefit).
  • Two Impella RP studies find that early identification of right heart failure and early use of Impella RP is associated with significantly higher survival rates. The ongoing PMA post-approval study, RECOVER RIGHT, presented by Mark Anderson, MD, found patients who received Impella RP support within 48 hours of cardiogenic shock onset had a significantly higher survival rate than those who received delayed right-heart support (73% vs. 14%, p<0.001). Another study, presented by Babar Basir, DO, found persistent diastolic suction alarms on the Automated Impella Controller (AIC) and an elevated central venous pressure of greater than 12mmHg can be an early indication of Right Ventricular Failure.

• On October 20, the company hosted a virtual investor meeting to review new clinical data presented at TCT Connect. The virtual meeting included a presentation from Chuck A. Simonton, MD, Vice President and Chief Medical Officer.

• On October 26, the company announced the United States Food and Drug Administration (FDA) granted a 510(k) clearance for Abiomed’s Breethe OXY-1 cardiopulmonary bypass support system.

• On October 28, the company announced the first two patients have been treated with the Impella ECP expandable percutaneous heart pump as part of an FDA Early Feasibility Study. Impella ECP is the smallest heart pump in the world.

“I am proud to report that we achieved our Q2 ‘Yellow’ phase goals and grew sequentially, stabilized revenue in the US and increased revenue double digits outside of the U.S while advancing our regulatory, clinical and engineering milestones,” said Michael R. Minogue, Abiomed’s Chairman, President and Chief Executive Officer. “I am also proud of the Patients First commitment and leadership from our employees and customers to recover hearts and save lives every day.”

THIRD QUARTER 2021 REVENUE OUTLOOK
Similar to the revenue performance in the second quarter of fiscal year 2021, the company anticipates sequential improvement in revenue in the third quarter fiscal year 2021. At this time, the company anticipates third quarter fiscal year 2021 global revenue to be in the range of $221 million to $230 million, representing flat to 4% growth compared to third quarter fiscal year 2020.

EARNINGS CONFERENCE CALL DETAILS
The company will host a conference call to discuss the quarterly results at 8:00 a.m. ET on Thursday, October 29, 2020. The conference call will be hosted by Michael R. Minogue, Chairman, President and Chief Executive Officer and Todd A. Trapp, Vice President and Chief Financial Officer.

To listen to the call live, please tune into the webcast via https://edge.media-server.com/mmc/p/or57h3yj or dial (855) 212-2361; the international number is (678) 809-1538. A replay of this conference call will be available beginning at 11:00 a.m. ET October 29, 2020 through 10:00 a.m. ET on November 5, 2020. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 5992445. BusinessWire