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Abiomed Reports Record U.S. Impella Utilization for First Quarter of Fiscal 2011

^{Published on 2010-08-04 12:15:29 - Market Wire}
 

DANVERS, Mass.--([ BUSINESS WIRE ])--[ Abiomed, Inc. ] (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today reported first quarter fiscal 2011 revenue of $22.0 million, up 11% compared to the same period of fiscal 2010.

"The first quarter of fiscal 2011 was highlighted by continued growth of the Impella commercial platform, strong enrollment in the Protect II trial and positive operational performance"

Total commercial U.S. Impella revenue, including initial site stocking orders and reorders, totaled $15.5 million, a 48% increase compared to $10.5 million in the first quarter of fiscal 2010. Commercial U.S. Impella reorders of $13.7 million were up 114% from $6.4 million in the first quarter of fiscal 2010 and represented 88% of commercial U.S. Impella revenue.

Worldwide Impella revenue totaled $16.6 million, up 38% compared to revenue of $12.0 million in the prior year.

Financial and operating highlights during the first quarter of fiscal 2011 include:

• Approximately 595 U.S. commercial patients were treated with Impella(R) 2.5, 5.0 or LD, a 74% increase compared to approximately 341 commercial patients in the first quarter of fiscal 2010.
• 49 patients were enrolled in the Protect II study, for a total of 390 patients completed, or 60% of the 654 patients required.
• An additional 24 U.S. hospitals purchased Impella 2.5 for commercial use during the quarter, bringing the total to 437 commercial customers, as compared to 47 hospitals added in the first quarter of fiscal 2010.
• Gross margin rate for the first quarter of fiscal 2011 was 76%, compared to 75% in the first quarter of fiscal 2010.
• Non-Impella revenue was $5.4 million for the first quarter of fiscal 2011, 32% lower than $7.9 million in the first quarter of fiscal 2010. The decline in non-Impella revenue was attributed partially to the Companya™s restructuring of its surgery business and the exiting of distributors in Europe.
• GAAP net loss for the first quarter of fiscal 2011 was $6.0 million, or $0.16 per share, compared to a GAAP net loss of $7.8 million, or $0.21 per share for the first quarter of fiscal 2010.
• Non-GAAP net loss, which is described later in this press release for the first quarter of fiscal 2011 was $3.7 million, or $0.10 per share versus non-GAAP net loss of $5.7 million or $0.16 per share, in the first quarter of fiscal 2010.
• Cash, cash equivalents and short-term marketable securities totaled $54.9 million at June 30, 2010 compared to $58.3 million at March 31, 2010.
• At EuroPCR in May 2010, Abiomed announced latest results from USpella, a U.S. multicenter, observational registry of Impella 2.5(R) patients. The full presentation can be viewed [ here ].

aThe first quarter of fiscal 2011 was highlighted by continued growth of the Impella commercial platform, strong enrollment in the Protect II trial and positive operational performance,a said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. aOur strategy is moving forward as we go deeper into existing U.S. Impella sites, training to independent use and expanding applications while amassing an extensive body of clinical evidence for hemodynamic support and heart muscle recovery.a

The Company will host a conference call to discuss the results on Wednesday, August 4, 2010, at 8:00 a.m. ET. Michael R. Minogue, Chairman, President and Chief Executive Officer and Robert L. Bowen, 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 800.599.9829; the international number is 617.847.8703. The access participant code is 75175627. A replay of this conference call will be available beginning at 11 a.m. ET on August 4, 2010 through 11:59 p.m. ET on August 18, 2010. The replay phone number is 888.286.8010; the international number is 617.801.6888. The replay access code is 23715383.

ABOUT ABIOMED

Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support to acute heart failure patients across the continuum of care in heart recovery. Our products are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping of the heart. For additional information please visit: [ www.abiomed.com ].

USE OF NON-GAAP MEASURES

In addition to financial measures prepared in accordance with generally accepted accounting principles (GAAP), this earnings announcement also contains non-GAAP financial measures of net loss and net loss per share, in each case excluding, where appropriate, stock-based compensation, intangibles amortization and other costs, expenses or income, all as further detailed in the financial tables accompanying this earning announcement, which management believes are useful supplemental information to management and investors regarding the performance of the companya™s business operations, provide a greater transparency with respect to key metrics used by management in its decision making, facilitate comparisons of results for current periods and assist in analyzing future trends. We believe that the inclusion of these non-GAAP financial measures in this earnings announcement helps investors to gain a meaningful understanding of our core operating results and future prospects, and can also help investors who wish to make comparisons between us and other companies on both a GAAP and a non-GAAP basis, particularly with respect to stock based compensation expenses. The non-GAAP financial measures included in this earnings announcement are not meant to be considered superior to or a substitute for results of operations prepared in accordance with GAAP. In addition, the non-GAAP financial measures included in this earnings announcement may be different from, and therefore may not be comparable to, similar measures used by other companies. Although certain non-GAAP financial measures used in this release exclude the accounting treatment of stock based compensation expense and other items outlined in this release and above, these non-GAAP measures should not be relied upon independently, as they ignore the contribution to our operating results that is generated by the incentive and compensation effects of the underlying stock based compensation programs.

FORWARD-LOOKING STATEMENTS

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, regulatory approvals, anticipated future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, 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 Annual Report filed on Form 10-K. 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.

Abiomed, Impella, iPulse, BVS5000, AB5000, AbioCor and the Abiomed logo are all trademarks of Abiomed. Other company and product names may be trademarks of their respective owners.