DANVERS, Mass., Feb. 6, 2013 (GLOBE NEWSWIRE) -- Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today reported third quarter fiscal 2013 revenue of $38.3 million, up 19% compared to revenue of $32.2 million in the same period of fiscal 2012, on record quarterly patient usage, up 26% compared to the same period of fiscal 2012. Abiomed also reported third quarter fiscal 2013 GAAP net income of $2.7 million, or $0.07 per diluted share, compared to GAAP net income of $2.9 million, or $0.07 per diluted share in the same period of fiscal 2012.
Recent financial and operating highlights include the following:
- Fiscal third quarter worldwide Impella revenue totaled $33.5 million, up 21% compared to revenue of $27.7 million during the same period of the prior year. U.S. Impella revenue grew 22% to $31.1 million from $25.5 million in the prior year.
- As projected, an additional 23 hospitals purchased Impella 2.5 during the quarter, compared to 37 new Impella 2.5 sites in the same period of the prior year, bringing the total to 718 U.S. Impella customer sites.
- Following a market evaluation of the Impella CP™ in Europe during the second quarter of fiscal 2013, Abiomed began a controlled Impella CP launch to select U.S. customer sites in September 2012. As part of this launch, 34 hospitals purchased Impella CP during the third quarter, bringing the total number to 46 U.S. Impella CP customer sites.
- Gross margin rate for the third quarter of fiscal 2013 was 78.7% compared to 80.5% in the third quarter of fiscal 2012. The decline was largely due to costs related to capacity expansion initiatives and start up of the Impella CP production.
- Cash, cash equivalents and short-term marketable securities totaled $85.7 million as of December 31, 2012. During the quarter, the Company repurchased 800,000 shares of stock for $10.7 million. Net cash provided by operating activities less capital expenditures totaled $7.3 million for the quarter.
- In November, the Center for Medicare and Medicaid Services announced the valuation of the three new dedicated Category I Current Procedure Terminology (CPT) codes for Impella, which became effective January 2013. The total for all three CPT codes, which apply to the insertion, repositioning and removal of Impella percutaneous devices, is $833.
- Also in November, Abiomed received U.S. Food & Drug Administration (FDA) Investigational Device Exemption (IDE) approval enabling the use of the Impella RP in a pivotal clinical study called RECOVER RIGHT. This study will collect safety and effectiveness data on the percutaneous use of the Impella RP and will be applied towards the submission of a Humanitarian Device Exemption (HDE).
- In December, Abiomed announced the 515i FDA panel recommendation of a Class III status for the temporary ventricular support devices in the non-roller type cardiopulmonary bypass blood pump category. Abiomed continues to market the Impella family of heart pumps under the existing 510(k) clearances while working with FDA to submit the necessary clinical data under the Post Market Approval (PMA) application process.
"We are excited to announce that we achieved a record quarter for patient utilization, which reflects the continued growth in physician demand for Impella," said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. "We are also encouraged by the strong interest in the Impella CP launch and awareness surrounding the new CPT physician payment codes for Impella that went into effect in the beginning of 2013."