DANVERS, Mass., May 2, 2013 (GLOBE NEWSWIRE) -- Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today reported fourth quarter fiscal 2013 revenue of $43.7 million, up 17% compared to revenue of $37.3 million in the same period of fiscal 2012, and fourth quarter fiscal 2013 GAAP net income of $3.7 million or $0.09 per diluted share, compared to GAAP net income of $2.6 million or $0.06 per diluted share in the prior year. For the full fiscal year 2013, total revenue was $158.1 million, up 25% compared to $126.4 million for fiscal year 2012, and GAAP net income was $15.0 million or $0.37 per share, compared to GAAP net income of $1.5 million or $0.04 per diluted share in the prior year.
Financial and operating highlights during the fourth quarter of fiscal 2013 include the following:
- As previously announced on April 17, 2013, fiscal fourth quarter worldwide Impella® revenue totaled $39.3 million, up 22% compared to revenue of $32.3 million during the same period of the prior year. Full year worldwide Impella revenue totaled $140.3 million, up 31% compared to $106.9 million for fiscal year 2012.
- Fiscal fourth quarter U.S. Impella revenue grew 22% to $36.5 million from $29.9 million in the prior year. Full year U.S. Impella revenue grew 32% to $131.3 million from $99.1 million in the prior year.
- An additional 30 hospitals purchased Impella 2.5 during the quarter, bringing the total to 748 U.S. Impella customer sites. As part of Abiomed's continued controlled Impella CP launch, an additional 55 hospitals purchased Impella CP™, bringing the total number of Impella CP U.S. sites to 106.
- Gross margin rate for the fourth quarter fiscal 2013 was 79.8% compared to 81.8% in the prior year. For the full fiscal year, gross margin rate was 80.0% compared to 80.6% in the prior year.
- Operating margin rate for the fourth quarter fiscal 2013 was 9.5%, compared to 7.9% in the prior year period. For the full fiscal year, operating margin rate was 10.4% compared to 1.2% in the prior year.
- Cash, cash equivalents, short and long-term marketable securities totaled $88.1 million as of March 31, 2013, an increase of $2.4 million from December 31, 2012. 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, 2012.
- Abiomed announced in February that it received a close-out letter from the Food and Drug Administration (FDA) Office of Compliance with respect to its previous FDA warning letter dated June 10, 2011. The close-out letter stated that the FDA Office of Compliance has completed its evaluation of the corrective actions taken by Abiomed in response to the previously disclosed FDA warning letter and that the concerns cited in that letter appear to have been addressed.
- In February, an economic study on the use of percutaneous ventricular assist devices (pVAD) was published in the February edition of The Journal of Managed Care Medicine ( JMCM), "A Budget Impact Model to Estimate the Cost Dynamics of Treating High-Risk Heart Failure Patients with Advanced Percutaneous Cardiac Assist Devices: The Payer Perspective." Additionally, in May, the PROTECT II cost-effective study was published in the American Health and Drug Benefits Journal.
- Abiomed also announced several reimbursement milestones in March, including recent Impella coverage decisions from national payers including Humana, UnitedHealthcare, Independence Blue Cross and Capital BlueCross. The recently updated coverage decisions include new Impella policies in the payers' commercial and/or Medicare Advantage plans.
- In April, Abiomed also announced the enrollment of the first patient in RECOVER RIGHT, an Investigational Device Exemption (IDE) study of Impella ® RP (Right Peripheral). The Impella RP is a percutaneous heart pump that is implanted through a single access site in the patient's leg and deployed through the venous system, across the right side of the heart without requiring a surgical procedure. The RECOVER RIGHT clinical study, which received FDA IDE approval to begin in November 2012, will enroll 30 patients that present with signs of right side heart failure and are being treated in the catheterization lab or cardiac surgery suite.
"We are proud to report another record quarter and record fiscal year in both number of patients supported and total revenue," said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. "Our company has transformed into a resilient commercial organization, that is profitable, debt free and expanding the number of exclusive regulatory approvals, breakthrough innovative products and geographical reach."
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