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ANSV
Anesiva
Note: Anesiva released its Q4 2006 results without scheduling a conference for stockholders and analysts. The following information is from their press release.
conference date: February 8, 2006
for quarter ending: December 31, 2006 (4th quarter)
Overview: No surprises. Waiting on FDA approval for Zingo.
"2006 was a tremendous year for Anesiva with the filing of our New Drug Application (NDA) for Zingo(TM) and the robust data observed in the 4975 clinical trials to date," said John P. McLaughlin, chief executive officer of Anesiva. "We are rapidly moving forward with our commercialization plans for Zingo."
"In addition to commercialization of Zingo, we are executing an extensive clinical development program for our promising pain candidate, 4975 for which we anticipate commencing a series of late-stage Phase 2 and 3 clinical studies initially focused on treating pain associated with total knee replacement surgery and osteoarthritis of the knee, as well as expanding testing into two new patient populations for the treatment of pain associated with hip and shoulder surgeries," continued Mr. McLaughlin.
Fourth Quarter and Year-End 2006 Financial Results
Total operating expenses in the fourth quarter of 2006 were $16.2 million, which includes $2.3 million of non-cash stock-based compensation, and in the fourth quarter of 2005 were $15.5 million. For the year-ended December 31, 2006, operating expenses were $58.8 million, which includes $11.3 million of non-cash stock-based compensation, and for the year-ended December 31, 2005 were $36.5 million.
The operating expenses during the quarter primarily related to the continued development and commercial preparation to launch the company's lead product candidate Zingo. Additional operating expenses related to the ongoing development of product candidates including 4975.
For the fourth quarter of 2006, the net loss was $15.3 million, or $0.65 loss per share. In the fourth quarter of 2005, the net loss was $13.1 million, or $2.90 loss per share. The net loss for the year-ended December 31, 2006 was $55.6 million, or $2.69 loss per share, and for the year ended December 31, 2005, the net loss was $33.5 million or $ 16.89 per share. The fourth quarter of 2006 represents the fourth full quarter of combined financial results following the December 15, 2005 completion of our merger between Anesiva and AlgoRx Pharmaceuticals, Inc. The net loss in the fourth quarter of 2005 is after an extraordinary gain of $1.7 million related to the purchase accounting for the merger.
Common shares outstanding at December 31, 2006 were 27.3 million shares, which includes seven million newly issued shares sold in November 2006 to select institutional investors through an over-subscribed registered direct common stock offering completed at market, raising approximately $45 million.
As of December 31, 2006, cash, cash equivalents and short-term investments were $85.1 million compared to $94.9 million at December 31, 2005. The company expects that this will be enough cash to fund the company's activities into 2008. Anesiva will not be providing more specific financial guidance for 2007 at this time. The company recently completed a successful meeting with the FDA enabling the company to define its clinical plan for 4975. Details of the specific clinical trials are currently being finalized, and once that is completed, Anesiva will provide additional financial guidance for 2007.
About Anesiva and its Diverse Pipeline of Pain Products
Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. The company has two drug candidates in development for multiple pain-related indications. An NDA has been submitted for the most advanced product, Zingo. The second product in the pipeline, 4975, has been shown to reduce pain after only a single administration for weeks to months in multiple settings in numerous mid-stage clinical trials for site-specific, moderate-to-severe pain. Anesiva is based in South San Francisco, CA.
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Copyright 2007 William P. Meyers