DANVERS, Mass., Aug. 1, 2013 (GLOBE NEWSWIRE) -- Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today reported first quarter fiscal 2014 revenue of $42.7 million, up 10% compared to revenue of $38.8 million in the same period of fiscal 2013, and a first quarter fiscal 2014 GAAP net loss of $1.7 million or a loss of $0.04 per diluted share, compared to GAAP net income of $3.1 million or $0.08 per diluted share in the prior year period.
Financial and operating highlights during the first quarter of fiscal 2014 and fiscal year to date include:
- Fiscal first quarter worldwide Impella® revenue totaled $38.7 million, up 12% compared to revenue of $34.7 million during the same period of the prior year. U.S. Impella revenue grew 7% to $35.4 million from $33.0 million in the prior year with U.S. Impella patient usage up 12%.
- An additional 27 hospitals purchased Impella 2.5 during the quarter, bringing the total to 775 customer sites. As part of Abiomed's continued Impella CP™ launch, an additional 66 hospitals purchased Impella CP, bringing the total number of Impella CP U.S. sites to 172. Impella 2.5 and Impella CP unit inventory at hospitals averaged 2.4 units, equal to the prior sequential quarter.
- Gross margin rate for the first quarter of fiscal 2014 was 79.6% compared to 80.8% in the first quarter of fiscal 2013. There were 191 Impella AIC consoles placed during the quarter compared to 163 in the same period of the prior year.
- Income/(loss) from operations for the first quarter fiscal 2014 was a loss of $1.3 million, compared to a gain of $3.6 million in the prior year period. Compared to the prior year, the loss included $2.6 million of incremental legal expenses related to the Department of Justice subpoena, shareholder lawsuit and derivative action, $1.2 million of higher stock compensation expense and $0.6 million of incremental expense for the medical device tax.
- Cash, cash equivalents, short and long-term marketable securities totaled $88 million as of June 30, 2013, which remained unchanged from March 31, 2013. The Company continues to have no debt and a U.S. federal net operating loss carry-forward of approximately $190 million as of March 31, 2013.
- Abiomed announced in May the publication of the Protect II Cost Effectiveness Study in American Health & Drug Benefits Journal, demonstrating the cost effectiveness of Impella.
- Abiomed also announced that the Netherlands has approved new reimbursement coding and payment for the Impella product. The new coding allows for hospitals to receive funding for the use of the Impella technology in a broad set of clinical indications of heart disease through the process known as Diagnosis Treatment Combinations (Diagnose Behandeling Combinaties; DBCs), similar to the Medicare Diagnosis-Related Group (DRG) system in the United States.
- Abiomed also announced in June that the U.S. District Court of Massachusetts dismissed the derivative lawsuit that was filed in February 2013.
- There were several Impella-related sessions at the 22nd Annual Meeting of the Japanese Association of CardioVascular Intervention and Therapeutics (CVIT 2013) in Kobe, Japan, which took place July 11-13. Abiomed anticipates Japanese PMDA approval for Impella by the end of the year, with reimbursement to follow within 6 – 12 months.
- In July, the 15,000 th U.S. patient was treated with Impella.
- The Company has also received written notification that the U.S. Food and Drug Administration (FDA) has reviewed Abiomed's proposed premarket approval application (PMA) Shell for modular review of the Impella 2.5 System. The FDA has confirmed that the Agency agrees with Abiomed's proposed Shell and that the company may begin submitting modules.
"We are on track to achieve our fiscal year revenue guidance and set new records in patient utilization. We are investing for success in our training, regulatory approvals and product portfolio," said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. "We are pleased to report today that the FDA has recently approved our PMA Shell for our Impella modular submission."
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