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"The 2008 second quarter marked a significant advance for Anesiva as weintroduced Zingo(TM) in the U.S. pediatric hospital market," said Michael L.Kranda, president and chief executive officer. "In addition, I'm pleased toreport that our Phase 3 trials of Adlea(TM) for the management of acute painfollowing total knee replacement surgeries and bunionectomy surgeries arenearing full patient enrollment. As a result, we anticipate releasing top-linedata from both trials in the fourth quarter of this year."
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"While we continue to make progress in our current commercial and clinicalinitiatives, I am conducting a full strategic review of the company'sprograms, timelines and resource allocations," Mr. Kranda said. "Based on theresults of this evaluation, in early September I intend to present acomprehensive forward-looking plan for Anesiva's growth as a company focusedon the late-stage development and commercialization of novel products thataddress unmet needs in the treatment of pain." Mr. Kranda was appointedAnesiva's president, chief executive officer and member of the board ofdirectors in June 2008.
Second Quarter 2008 Financial Results
Total operating expenses in the second quarter of 2008 were $22.1 million,including $1.6 million in non-cash stock-based compensation, compared to totaloperating expenses of $14.7 million, including $2.4 million in non-cash stock-based compensation, in the second quarter of 2007. For the six months endedJune 30, 2008, total operating expenses were $43.9 million compared to$27.4 million for the six months ended June 30, 2007, and include $3.2 millionand $4.5 million in non-cash stock-based compensation in the 2008 and 2007periods, respectively.
Operating expenses during the quarter primarily related to the continueddevelopment and commercial preparations to launch, Zingo, a fast-acting,needle-free, local anesthetic, for the pediatric indication. Additionaloperating expenses related to the ongoing development of Adlea, which is beingevaluated in Phase 3 trials for the treatment of acute pain following totalknee replacement surgeries and bunionectomy surgeries.
For the second quarter of 2008, the net loss was $21.9 million, or $0.54per share. In the second quarter of 2007, the net loss was $13.8 million, or$0.51 per share. The net loss for the six months ended June 30, 2008 was $43.4million, or $1.08 per share, and for the six months ended June 30, 2007, thenet loss was $25.5 million or $0.93 per share.
As of June 30, 2008, cash, cash equivalents and investments were$48.7 million compared to $90.8 million at December 31, 2007. The companybelieves it has sufficient resources to fund anticipated expenses for theremainder of 2008 and into 2009.
Commenting on the initial Zingo launch, Nancy E. Donahue, senior vicepresident, sales and marketing, said, "While it is too early to providemeaningful sales metrics as we are just six weeks into the launch, initialqualitative feedback from healthcare providers who have used Zingo suggeststhat they are very pleased with its performance and ease of use. We continueto conduct training sessions for selected healthcare providers to advocate forbetter venous access pain management for their pediatric patients, to growmembership in RNVoice, and to experience increased visits tohttp://www.manageivpain.com."
About Anesiva and its Diverse Pipeline of Pain Products
Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to bethe leader in the development and commercialization of novel pharmaceuticalproducts for pain management. The company's first commercial product,Zingo(TM), is available in the U.S. for the reduction of pain associated withperi
