DANVERS, Mass., Nov. 01, 2018 — Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart recovery and support technologies, today reported second quarter fiscal 2019 revenue of $181.8 million, an increase of 37% compared to revenue of $132.8 million for the same period of fiscal 2018. Second quarter fiscal 2019 GAAP net income was $50.1 million or $1.09 per diluted share, up 104% compared to GAAP net income of $24.5 million or $0.54 per diluted share for the prior year period.
Recent financial and operating highlights include:
- Worldwide Impella® heart pump revenue for the quarter totaled $175.3 million, an increase of 38% compared to revenue of $127.4 million during the same period of the prior fiscal year.
- U.S. Impella heart pump revenue for the quarter totaled $152.2 million, an increase of 34% compared to revenue of $113.6 million during the same period in the prior fiscal year with U.S. patient usage of the Impella heart pumps up 29%.
- Outside the U.S., Impella heart pump revenue for the quarter totaled $23.1 million, an increase of 67% compared to revenue of $13.8 million during the same period in the prior fiscal year.
- Gross margin for the second quarter fiscal 2019 was 83.6% compared to 83.7% during the same period in the prior fiscal year.
- Operating income for the second quarter fiscal 2019 was $50.3 million, or 27.7% operating margin, compared to $31.7 million, or 23.9% operating margin in the prior fiscal year.
- Second quarter fiscal 2019 GAAP net income was $50.1 million, or $1.09 per diluted share, which benefited from $12.9 million, or $0.28 per diluted share, of excess tax benefits related to employee share-based compensation awards. This compared to GAAP net income of $24.5 million or $0.54 per diluted share for the prior fiscal year, which benefited from $4.5 million, or $0.10 per diluted share, of excess tax benefits.
- The Company’s cash and marketable securities balance as of September 30, 2018 was $410.4 million. The Company currently has no debt.
- In September 2018, a data analysis presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference from Abiomed's Impella® Quality (IQ) Database showed that the utilization of best practices, including early placement of Impella, pre-PCI, led to a 24% relative increase in mean survival for acute myocardial infarction (AMI) cardiogenic shock patients since Impella’s cardiogenic shock FDA post-market approval (PMA) in 2016. The percent of Impella hospitals achieving greater than 70% survival now total 39%, up from 25% prior to the FDA approval.
- Separately at TCT, William O’Neill, MD, medical director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit, presented initial data from the first 104 patients treated with the National Cardiogenic Shock Initiative (NCSI) protocol. After more than 20 years of stagnant shock survival rates at roughly 50%, NCSI has now demonstrated a survival of 77%, with 99% of survivors discharged home with their native heart. The NCSI protocol includes placing Impella pre-PCI, reducing the use of inotropes, and right heart hemodynamic monitoring. NCSI is an independent, physician-led collaboration to improve outcomes in cardiogenic shock.
- The Company announces the STEMI DTU FDA safety and feasibility study will be presented in the Late-Breaking Clinical Trials at 10:00 a.m. CST on November 11th at the American Heart Association (AHA) Scientific Sessions in Chicago. More information is available at the following link: http://www.abstractsonline.com/pp8/#!/4682/presentation/59042.
- Today, the Company announces that it will host a short investor call to discuss the STEMI DTU FDA safety and feasibility study results on Monday, November 12 at 8:00 a.m. EST.
“We have established a strong foundation with our innovation and technology, balance sheet and intellectual property portfolio,” said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed, Inc. “We are executing our plan for sustainable growth while helping to improve patient outcomes focused on native heart recovery.”
FISCAL YEAR 2019 OUTLOOK
The Company is again increasing the low end of its fiscal year 2019 revenue guidance to $765 million to $770 million (up 29% to 30% over the prior fiscal year). This compares to the post fiscal first quarter guidance of $755 million to $770 million (up 27% to 30% over the prior fiscal year) and the Company's initial forecast of $740 million to $770 million (up 25% to 30% from the prior year). The Company is maintaining its fiscal year 2019 guidance for GAAP operating margin in the range of 28% to 30%.
Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com
This release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities and expected regulatory approvals. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.