CHICAGO, Feb. 11 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. , a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases, today announced its financial results for the fourth quarter and full year ended December 31, 2008.
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The net loss allocable to common shareholders for the three months ended December 31, 2008 was $2.8 million or ($0.07) per share compared to a net loss allocable to common shareholders of $5.6 million or ($0.18) per share for the three months ended December 31, 2007. The net loss allocable to common shareholders for the full year 2008 was $23.0 million or ($0.59) per share compared to a net loss allocable to common shareholders of $32.5 million or ($1.12) per share for 2007. The decrease in the net loss for the full year 2008 is due to decreased costs involved in the clinical development of the Company’s lead compound cethromycin.
The Company used approximately $12.2 million in cash in the fourth quarter of 2008 and ended the year with cash totaling $1.5 million. Cash use for the full year was $24.5 million. Fourth quarter and full year cash use included a $10.0 million milestone payment to Abbott Laboratories associated with the submission of the New Drug Application (NDA) for cethromycin.
“2008 was a transformative year in Advanced Life Sciences’ history, marking our transition from a development-stage to a pre-commercial company, working toward the market launch of our first product,” said Dr. Michael Flavin, Chairman and CEO of Advanced Life Sciences. “With the successful filing of our NDA for cethromycin, we have advanced our lead product candidate toward becoming a promising commercial product opportunity in a market that is in need of safe and effective new antibiotics. With the establishment of our Wyeth partnership in the Asia Pacific region, we have laid the cornerstone of our global commercialization strategy. In addition, the awarding of our multi- million dollar Defense Threat Reduction Agency (DTRA) contract is indicative of the potential for cethromycin and the significant market opportunity in the biodefense field.”
Continued Dr. Flavin: “As we look forward to the July 31, 2009, PDUFA date set by FDA for cethromycin, we are realigning our resources and cost structure to focus on our upcoming commercial objectives and intend to raise capital to strengthen our financial position.”
Financial Guidance for 2009
Advanced Life Sciences expects its 2009 cash requirements, excluding milestone payments that become due upon cethromycin NDA approval, to fall in the range of $12.0 million and $15.0 million. Cash use in the first quarter of 2009 is expected to fall in the range of $1.5 million and $2.0 million. The cash use will be applied toward cethromycin NDA regulatory support, pre- commercial activities and general operating expenses.
As the Company transitions towards commercialization of cethromycin, the following initiatives are being undertaken to conserve capital and strengthen the balance sheet:
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The Company’s independent registered public accounting firm included an explanatory paragraph in its report on the Company’s 2008 financial statements related to uncertainty in the Company’s ability to continue as a going concern. We anticipate that our independent registered public accounting firm will include a similar opinion in its report on the Company’s 2008 financial statements. There can be no assurance that it will be able to secure a commercial partnership or obtain adequate capital funding in the future to continue operations and implement its strategy, which would have an adverse effect on the Company’s business and operations.
Conference Call Details
Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Wednesday, February 11, 2009 to discuss the Company’s financial results for the fourth quarter and full year ended December 31, 2008.
The conference call will be webcast simultaneously over the Internet. Please visit the Investor Relations section of the Advanced Life Sciences corporate website http://www.advancedlifesciences.com. Alternatively, callers may participate in the conference call by dialing 888-680-0879 or 617-213-4856 (international). The passcode for the conference call is 25253515. A replay of the conference call will be available until February 18, 2009. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 89150902. Investors are advised to dial into the call at least ten minutes prior to the call to register. Participants may pre- register for the call at https://www.theconferencingservice.com/prereg/key.process?key=PNXL8438C. Pre- registrants will be issued a pin number to use when dialing into the live call which will provide quick access to the conference by bypassing the operator upon connection.
About Community Acquired Pneumonia (CAP)
CAP is the sixth most common cause of death in the United States. CAP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae. Approximately 5.6 million cases of CAP are diagnosed each year in the United States with 10 million physician visits, resulting in an estimated total annual expenditure of $2.0 billion dollars for prescribed antibiotics to treat CAP. CAP is potentially fatal if not treated properly, and the bacteria that cause CAP are developing resistance to current standard of care treatments.
Macrolides and penicillins are currently the front-line treatments for respiratory tract infections such as CAP. As macrolide and penicillin resistance grows and has the potential to cause more clinical failures, there is a need for new antibiotics with unique mechanisms of action that can overcome this emerging resistance.
About Cethromycin
Cethromycin has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections, and, again in in vitro tests, it appears to be effective against penicillin- and macrolide-resistant bacteria. Cethromycin has a mechanism of action that may slow the onset of future bacterial resistance. In addition to its utility in CAP, cethromycin is also being investigated for the prophylactic treatment of inhalation anthrax post- exposure. The FDA has designated cethromycin as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, but the drug is not yet approved for this or any other indication.
About Advanced Life Sciences
Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and inflammation. The Company’s lead candidate, cethromycin, is a novel once-a-day oral antibiotic under review by the FDA for the treatment of mild-to-moderate community acquired pneumonia. For more information, please visit us on the web at http://www.advancedlifesciences.com.
Forward-Looking Statements
Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our management’s judgment regarding future events. The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise. Our actual results could differ materially from those discussed herein due to several factors including the success and timing of our clinical trials and our ability to obtain and maintain regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, future revenues and capital requirements; our ability to obtain financing on terms acceptable to us; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers. These and additional risks and uncertainties are detailed in the Company’s filings with the Securities and Exchange Commission.
CONTACT: Joe Camp of Advanced Life Sciences Holdings, Inc.,
+1-630-754-4352, jcamp@advancedlifesciences.com
Web site: http://www.advancedlifesciences.com//
