Aug 04 2015
DANVERS, Massachusetts—Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today reported first quarter fiscal 2016 revenue of $73.4 million, an increase of 50% compared to revenue of $48.8 million for the same period of fiscal 2015. First quarter fiscal 2016 GAAP net income was $8.9 million or $0.20 per diluted share, compared to GAAP net loss of $1.7 million or a loss of $0.04 per diluted share for the prior year period.
Financial and operating highlights during the first quarter of fiscal 2016 include:
• Fiscal first quarter worldwide Impella® revenue totaled $68.8 million, an increase of 53% compared to revenue of $45.0 million during the same period of the prior fiscal year. U.S. Impella revenue grew 60% to $63.7 million from $39.9 million in the prior fiscal year with U.S. Impella patient usage up 62%.
• An additional 15 hospitals made initial purchases of Impella during the quarter, compared to 24 new hospital sites in the prior year period, bringing the installed customer base to 973 sites. As part of Abiomed’s continued Impella CP® launch, 54 new hospitals purchased Impella CP, bringing the total number of Impella CP U.S. sites to 694.
• An additional 15 sites made initial purchases of the Impella RP during the quarter, bringing the total number of Impella RP U.S. sites to 23.
• Gross margin for fiscal first quarter 2016 was 85% compared to 80% in the first quarter of fiscal 2015. Margins were boosted by favorable product mix and Euro exchange rates as well as increased factory utilization.
• Fiscal first quarter income from operations was $15.0 million, or operating margin of 20% compared to a loss from operations of $1.5 million in the prior year period.
• Cash, cash equivalents, short and long-term marketable securities totaled $156.4 million as of June 30, 2015, compared to $146.0 million at March 31, 2015. The Company continues to have no debt.
• In June, Abiomed announced that it received confirmation from the United States Department of Justice that it has closed its investigation into the company’s marketing of the Impella® 2.5 device without pursuing any enforcement action.
• On July 15, Abiomed hired Michael Tomsicek as the new Chief Financial Officer and Vice President. Former Abiomed CFO, Robert Bowen, retired on July 31.
• On July 31, Centers for Medicare and Medicaid Services (CMS) reconfirmed Impella reimbursement and payment. This marks more than eight years of review and validation of appropriate payment and confirms that existing Impella MS-DRG mapping (215-221) will remain unchanged in the ICD-9 to ICD-10 transition on October 1, 2015.
“After a full quarter of FDA approval for high-risk PCI with Impella 2.5, we feel that our customer education and training efforts are truly making an impact on our business,” said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed. “Our license to become the standard of care has transformed into a reality and I’m proud of the discipline and execution we have demonstrated to get to this phase of the Company’s financial and regulatory success.”
FISCAL YEAR 2016 OUTLOOK
The Company is increasing its fiscal year 2016 guidance for total revenue to be in the range of $300 million to $310 million, an increase of 30% to 35% from the prior year. This new range compares to the previous estimated range of $285 million to $295 million. The Company is updating its fiscal year guidance for GAAP operating margin to be in the range of 14% to 16%.
The Company will host a conference call to discuss the results on Tuesday, August 4, 2015, at 8:00 a.m. EDT. Michael R. Minogue, Chairman, President and Chief Executive Officer; Michael Tomsicek, Vice President and Chief Financial Officer, will host the conference call.
To listen to the call live, please tune into the webcast via http://investor.abiomed.com or dial (855) 212-2361; the international number is (678) 809-1538. A replay of this conference call will be available beginning at 11 a.m. EDT August 4, 2015 through 11:59 p.m. EDT on August 6, 2015. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 84865758.
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.
For further information please contact:
Director, Investor Relations
Director, Corporate Communications