Abiomed, Inc. (Abiomed) has reported revenues of $17.3 million for the fiscal third quarter of 2009, up 8%, compared with revenues of $16 million in the year-ago quarter. It reported net loss of $7.7 million, or $0.21 per share, for the fiscal third quarter of 2009, compared with the net loss of $8.3 million, or $0.26 per share, in the year-ago quarter.
Revenue for the nine months ended December 31, 2008 was $53.6 million, up 29% compared to revenue of $41.4 million in the first nine months of fiscal 2008.
As of December 31, 2008, 163 US hospitals had purchased Impella 2.5 for commercial 510(k) use, as compared to 108 hospitals that had purchased Impella 2.5 by the end of the prior quarter, a 51% increase.
Total Impella revenue was $8.9 million, up 112% for the third fiscal quarter of 2009 compared to the same period of fiscal 2008.
Impella revenue recorded during the third fiscal quarter of 2009 included $7.3 million in US sales, of which $6.7 million was for sales of Impella 2.5 sold under 510(k) clearance as compared to $6.2 million from the second quarter of fiscal 2009, representing an 8% sequential growth. Fiscal third quarter revenues of $0.6 million sold under the Protect II and Recover II trials compared to $2.6 million in the second quarter of fiscal 2009.
As of December 31, 2008, 85 U.S. hospitals are enrolling patients in the Protect II study for high-risk percutaneous coronary intervention (PCI) and 18 hospitals had submitted to the IRB or submission was pending. Overall, 180 patients from 49 hospitals were completed or 28% of the 654 patients required.
The assumptions for the Protect II major adverse event rate (MAE) are 20 and 30% for Impella and IABP respectively. At the Transcatheter Cardiovascular Therapeutics (TCT) Conference in October 2008, the Protect II Primary Investigator, William W. O’Neill, University of Miami Health System, stated that the initial aggregate adverse event rates for the trial are tracking in line with the 25% expected rate at 20% completion of the study.
As of December 31, 2008, one patient has been enrolled out of the seven U.S. hospitals that were enrolling patients in the Impella 2.5 Recover II study for acute myocardial infarction (AMI), 10 sites have IRB approval and not yet ready to enroll, and 24 sites have submitted for IRB approval.
Total non-Impella business revenue (BVS 5000, AB5000, iPulseTM, intra-aortic balloon or IAB, AbioCor, service and other) was $8.4 million for the third fiscal quarter of 2009 and decreased $3.4 million or approximately 29% compared to the same period of fiscal 2008.
A total of 771 pumps were shipped during the quarter (excluding IAB disposables) as compared to 676 in the third quarter of fiscal 2008, representing a 14% increase in the number of units shipped. Total disposables, service and other revenue (non-console revenue) comprised approximately 93% of total revenue for third quarter of fiscal 2009.
Gross margin for the third quarter of fiscal 2009 was 74% compared to 76% for the same period of fiscal 2008.
The third quarter of fiscal 2009 GAAP net loss was $7.7 million or $0.21 per share, down from a GAAP net loss of $8.3 million or $0.26 per share during the third quarter of fiscal 2008. Third quarter fiscal 2009 GAAP net loss included stock-based compensation expense of $1.9 million and intangibles amortization of $0.4 million. Fiscal 2008 GAAP net loss included stock-based compensation expense of $1.4 million and intangibles amortization of $0.4 million.
The non-GAAP net loss, excluding stock-based compensation and intangibles amortization expense, for the third quarter of fiscal 2009 was approximately $5.4 million, or $0.15 per share, a decrease compared to the non-GAAP net loss for the third quarter of fiscal 2008 which was $6.5 million, or $0.20 per share.
The net cash used for operating activities for the third quarter of fiscal 2009 was $2.5 million, which included a $1.9 million write down of the Columbia Fund Investments. At December 31, 2008, the Company had cash and short-term marketable securities of $63.8 million.
“Impella 2.5 is now at 76% of the top 50 heart hospitals listed in the US World & News Report, after six months of 510(k) clearance, ” said Michael R. Minogue, chairman, president and chief executive officer, Abiomed. “In addition to our ongoing Impella momentum and customer adoption, we have significantly reduced our cash burn this quarter.”
For the fiscal year 2009, the company believes worldwide revenues will be at the lower end of the previously guided range of $75-80 million.