SOUTH SAN FRANCISCO, Calif., Nov. 1 /PRNewswire-FirstCall/ -- Anesiva, Inc. today reported financial results for the third quarter ended September 30, 2007 and provided an update on the significant progress made in both the commercialization plans for Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal injection system and its clinical development programs for Adlea(TM), the company's long-acting non-opioid analgesic drug candidate.
"This was an exceptional quarter for Anesiva as we gained U.S. FDA approval of our first drug, Zingo, successfully completed a Phase 3 trial in adult patients to expand the label for Zingo, and announced our development plan for approval of Adlea for the broad product label of management of post-surgical pain associated with orthopedic surgeries," said John McLaughlin, chief executive officer of Anesiva.
Third Quarter 2007 Financial Results
Total operating expenses in the third quarter of 2007 were $16.0 million, including $2.1 million of non-cash stock-based compensation, compared to total operating expenses of $12.7 million, including $2.6 million of non-cash stock-based compensation, in the third quarter of 2006. For the nine months ended September 30, 2007, operating expenses were $43.3 million compared to $42.7 million for the nine months ended September 30, 2006.
The operating expenses during the quarter primarily related to the continued development and commercial preparations to launch the company's lead product candidate Zingo, a fast-acting, needle-free, local anesthetic. Additional operating expenses related to the ongoing development of Adlea, which has been shown in numerous clinical studies to provide site-specific, moderate-to-severe pain relief for weeks to months following a single application.
For the third quarter of 2007, the net loss was $16.1 million, or $0.58 per share. In the third quarter of 2006, the net loss was $11.9 million, or $0.59 per share. The net loss for the nine months ended September 30, 2007 was $41.6 million, or $1.51 per share, and for the nine months ended September 30, 2006, the net loss was $40.3 million or $2.04 per share.
As of September 30, 2007, cash, cash equivalents and investments were $54.5 million compared to $62.8 million at June 30, 2007. Common shares issued and outstanding totaled 28.0 million at September 30, 2007.
Updated Financial Guidance for 2007
Anesiva provided an update to its financial guidance for the full year 2007. The company reduced the range of its expected net loss by $5 million and increased the range of its cash, cash equivalents, and short term investments by $5 million:
At this time, revenue projections are not included in the company's financial guidance for 2007.
Conference Call Details
Anesiva will conduct a webcast conference call with the investment community at 4:30 p.m. EDT, today, November 1, 2007 to discuss the third quarter 2007 results and to review the company's progress and future outlook. Interested parties can listen to the live audio webcast by dialing 877-886-3540 (international dial: 706-643-9304) or by logging on to http://www.anesiva.com and going to the Investor Information page. For those unable to participate via the Internet, a 24-hour replay will be available for seven days after the call by dialing 800-642-1687 (international dial: 706-645-9291) and giving the following pass code: 21417682. The webcast will be available until the company's next quarterly financial results conference call.
About Anesiva and its Diverse Portfolio 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 one FDA-approved product, Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal injection system, to reduce pain associated with peripheral venous access procedures in children three to 18 years of age. Zingo also met all of its primary endpoints in a Phase 3 clinical trial in adults to expand its label indication for adults of all ages. The second product in Anesiva's pipeline, Adlea(TM) (formerly 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. For more information about Anesiva's leadership in the development of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to http://www.anesiva.com.
Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: the timing and results of our clinical trials, whether Anesiva is able to manufacture its products on commercially reasonable terms, whether Anesiva can secure FDA approval for the use of Zingo in adults, and the degree to which Zingo gains market acceptance. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva's quarterly report on Form 10-Q for the quarter ended June 30, 2007.
Anesiva undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.
CONTACT: Paul Goodson, Sr. Dir., Investor Relations, +1-650-246-6898,
investors@anesiva.com, or Jennifer Cook Williams, Investor Relations,
+1-650-246-6963, investors@anesiva.com, both of Anesiva, Inc.
Web site: http://www.anesiva.com/
