The company also reported revenue of $19.6 million for fourth quarter of fiscal 2009, up 12% compared to revenue of $17.5 million for the fourth quarter of fiscal 2008, and up 13% sequentially, compared to revenue of $17.3 million for the third quarter of fiscal 2009.
Recent financial and operating highlights during the fourth quarter of fiscal 2009 include:
Worldwide Impella revenue was $11.2 million, up 124% compared to revenue of $5.0 million for the fourth quarter of fiscal 2008 and up 26% sequentially, compared to revenue of $8.9 million for the third quarter of fiscal 2009.
Impella US revenue totaled $9.9 million, of which $9.1 million was for sales of Impella 2.5 under 510(k) clearance, up 36% sequentially, compared to revenue of $6.7 million for the third quarter of fiscal 2009.
Approximately 261 US patients were treated with Impella 2.5 under the 510(k) clearance, up 63% from approximately 160 patients treated in the third quarter and up 161% from approximately 100 patients treated within the first four months after the 510(k) clearance in June 2008. For the full year fiscal 2009, approximately 521 US patients were supported with Impella 2.5 under the 510(k) clearance.
During the quarter, over 50% of total Impella 2.5 510(k) revenue was from reorders and reorder rates exceeded 80% of patient utilization.
An additional 66 US hospitals purchased Impella 2.5 for general use, bringing the total to 229 general use customers or 14% of potential 1,700 US hospitals with catheterization labs (cath labs). The average order for new Impella sites was three disposable units.
A total of 95 hospitals are participating in the Protect II study and 43 patients were enrolled, for a total of 223 patients completed in the Protect II study, or 34% of the 654 patients required.
Legacy revenue was $8.4 million, 33% lower than the fourth quarter of fiscal 2008. The fourth quarter of fiscal 2008 legacy revenue included $1.3 million in revenues from the initial hospital start-up of the AbioCor.
On March 30, 2009, Abiomed announced it had received US Food and Drug Administration (FDA) approval of its Premarket Approval Application (PMA) supplement for the AB Portable™ Driver. Additionally, on April 22, 2009, Abiomed announced that it had received US Food and Drug Administration (FDA) 510(k) clearance of its Impella® 5.0 and Impella® LD Circulatory Support Devices.
The GAAP net loss was $8.5 million, or a loss of $0.23 per fully diluted share, compared to a GAAP net loss of $15.0 million, or a loss of $0.46 per fully diluted share during the fourth quarter of fiscal 2008.
The non-GAAP net loss for the fourth quarter of fiscal 2008, after excluding stock-based compensation expense of $1.8 million, intangibles amortization expense of $0.4 million, was $6.3 million, or a loss of $0.17 per fully diluted share, compared to the non-GAAP net loss for the fourth quarter of fiscal 2008, after excluding stock-based compensation expense of $1.1 million, intangibles amortization of $0.4 million, and a non-cash charge of $5.6 million for the change in fair value of the company’s note receivable from World Heart Corporation, which was $7.9 million, or a loss of $0.24 per fully diluted share. The non-GAAP net loss for the full fiscal year 2009, after excluding stock-based compensation expense of $8.8 million and intangibles amortization of $1.6 million, was $21.2 million, or a loss of $0.61 per fully diluted share, compared to the non-GAAP net loss for the full fiscal year 2008, after excluding stock-based compensation expense of $5.4 million, intangibles amortization of $1.6 million, a litigation settlement of $1.2 million, and a non-cash charge of $5.0 million for the change in the fair value of the company’s note receivable from World Heart Corporation, which was $27.7 million, or a loss of $0.85 per fully diluted share.
Cash, cash equivalents plus short and long-term marketable securities totaled $60.9 million compared to $63.8 million at December 31, 2008.
“Fiscal 2009 showcased the US market demand for Impella 2.5 minimally invasive heart recovery technology, demonstrated by its rapid adoption and utilization, during a difficult financial time for our customers,” said Michael R. Minogue, chairman, president and chief executive officer of Abiomed. “We quickly surpassed our fiscal 2009 goal of penetrating 100 hospitals and supporting 100 patients by reaching 229 hospital sites and 521 patients in ten months. In addition, we reduced the cash burn, raised additional funds, and executed on our US regulatory path with four new product introductions over the last 12 months. In fiscal 2010, we are focused on growing shareholder value by further increasing Impella utilization and expanding its clinical utility.”
