DANVERS, Mass., Oct. 30, 2014 (GLOBE NEWSWIRE) -- Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today reports second quarter fiscal 2015 revenue of $51.9 million, an increase of 17% compared to revenue of $44.3 million for the same period of fiscal 2014. Second quarter fiscal 2015 GAAP net income was $3.8 million or $0.09 per diluted share, compared to GAAP net income of $1.1 million or $0.03 per diluted share for the prior year period.
Today, Abiomed announces that the Company and the Food & Drug Administration (FDA) have agreed on the indication for use for high-risk PCI for the Impella® 2.5 Pre-Market Approval (PMA). Based on the information available to the Company to date, including multiple discussions with the FDA, the Company no longer anticipates the requirement for an FDA panel and expects PMA approval for the safety and effectiveness of the Impella 2.5 by February/March 2015.
Following approval of the Impella 2.5, the Impella® 5.0 and Impella CP® will be submitted as PMA supplements. Until the 515 process is completed, the Impella 5.0 and Impella CP will remain on the market under the existing 510(k) clearances.
The totality of data in the Impella 2.5 PMA submission includes two FDA approved studies: PROTECT I and PROTECT II totaling 472 patients which includes randomized data, 637 new high-risk PCI patients from the U.S. Impella registry, and clinical data from 215 publications, for a total of 1,638 Impella patients. The submission also contains a medical device reporting analysis from approximately 14,000 patients, and comes after six years of real-world U.S. Impella experience with over 24,000 patients treated post 510(k) clearance.
Financial and operating highlights during the second quarter of fiscal 2015 and fiscal year to date include:
"Abiomed achieved the highest quarterly revenue to date at $51.9 million, and has now grown top line revenue by double digits, year over year, for 20 straight quarters," said Michael R. Minogue, Chairman, President & Chief Executive Officer, Abiomed. "Abiomed's investment in clinical research, new products and patent portfolio, along with our disciplined approach in execution continue to provide Abiomed the opportunity to become the new standard of care and recognized leader in percutaneous circulatory support."
FISCAL YEAR 2015 OUTLOOK
The Company is increasing the lower end of its fiscal year 2015 revenue guidance with the new range of $209 million to $212 million from the original range of $205 million to $212 million. The Company is reiterating its fiscal year 2015 guidance for GAAP operating margin of 1% - 4%.
The Company will host a conference call to discuss the results on Thursday, October 30, 2014, 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 (855) 212-2361; the international number is (678) 809-1538. A replay of this conference call will be available beginning at 11 a.m. ET October 30, 2014 through 11:59 p.m. ET on November 6, 2014. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 5150124.
* The Impella RP is the subject of an investigational device exemption (IDE) clinical study and is limited by federal law to investigational use. The Impella RP currently is not available for sale in the United States.
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 press release contains "forward-looking statements," including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, future opportunities and expected regulatory approvals and statements about 2015 financial guidance. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "estimate," "expect," forecast," "intend, "may," "plan," "potential," "project," "target," "will" and other words and terms of similar meaning. These forward-looking statements include all matters that are not historical facts. The Company's actual results may differ materially from those results anticipated in these forward-looking statements based upon a number of factors, risks and uncertainties, 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. As a result of the foregoing, 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 update or revise these forward-looking statements whether as a result of new information, future events or otherwise, unless otherwise required by law.
|Abiomed, Inc. and Subsidiaries|
|Consolidated Balance Sheets|
|(in thousands, except share data)|
|September 30, 2014||March 31, 2014|
|Cash and cash equivalents||$ 17,483||$ 20,916|
|Short-term marketable securities||77,981||55,663|
|Accounts receivable, net||23,072||24,357|
|Prepaid expenses and other current assets||3,310||3,082|
|Total current assets||135,291||117,966|
|Long-term marketable securities||16,473||41,761|
|Property and equipment, net||7,351||6,889|
|In-process research and development||17,198||--|
|Total assets||$ 216,340||$ 205,407|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable||$ 7,616||$ 7,746|
|Total current liabilities||27,134||30,411|
|Other long-term liabilities||210||228|
|Long-term deferred tax liability||7,661||6,415|
|Commitments and contingencies|
|Class B Preferred Stock, $.01 par value||--||--|
|Authorized - 1,000,000 shares; Issued and outstanding - none|
|Common stock, $.01 par value||417||411|
|Authorized - 100,000,000 shares; Issued - 41,831,077 shares at September 30, 2014 and 41,122,695 shares at March 31, 2014; Outstanding - 40,577,134 shares at September 30, 2014 and 39,916,328 shares at March 31, 2014|
|Additional paid in capital||447,433||436,136|
|Treasury stock at cost - 1,253,943 shares at September 30, 2014 and 1,206,367 shares at March 31, 2014||(17,567)||(16,554)|
|Accumulated other comprehensive loss||(5,965)||(730)|
|Total stockholders' equity||175,538||168,353|
|Total liabilities and stockholders' equity||$ 216,340||$ 205,407|
|Abiomed, Inc. and Subsidiaries|
|Consolidated Statements of Operations|
|(in thousands, except share data)|
|Three Months Ended |
|Six Months Ended |
|Product revenue||$ 51,774||$ 44,288||$ 100,434||$ 86,897|
|Funded research and development||164||57||315||118|
|Costs and expenses:|
|Cost of product revenue||9,612||9,027||19,301||17,750|
|Research and development||8,693||7,721||17,755||15,008|
|Selling, general and administrative||29,455||26,199||61,053||54,166|
|Income from operations||4,178||1,398||2,640||91|
|Other income (loss):|
|Investment income, net||36||25||80||41|
|Other (loss) income, net||(39)||6||(28)||(15)|
|Income before income tax provision||4,175||1,429||2,692||117|
|Income tax provision||336||370||562||781|
|Net income (loss)||$ 3,839||$ 1,059||$ 2,130||$ (664)|
|Basic net income (loss) per share||$ 0.09||$ 0.03||$ 0.05||$ (0.02)|
|Basic weighted average shares outstanding||40,448||39,260||40,256||38,971|
|Diluted net income (loss) per share||$ 0.09||$ 0.03||$ 0.05||$ (0.02)|
|Diluted weighted average shares outstanding||42,239||41,337||42,069||38,971|
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