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The net loss allocable to common shareholders for the three months endedDecember 31, 2008 was $2.8 million or ($0.07) per share compared to a net lossallocable to common shareholders of $5.6 million or ($0.18) per share for thethree months ended December 31, 2007. The net loss allocable to commonshareholders for the full year 2008 was $23.0 million or ($0.59) per sharecompared 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 year2008 is due to decreased costs involved in the clinical development of theCompany's lead compound cethromycin.
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The Company used approximately $12.2 million in cash in the fourth quarterof 2008 and ended the year with cash totaling $1.5 million. Cash use for thefull year was $24.5 million. Fourth quarter and full year cash use included a$10.0 million milestone payment to Abbott Laboratories associated with thesubmission 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. MichaelFlavin, Chairman and CEO of Advanced Life Sciences. "With the successfulfiling of our NDA for cethromycin, we have advanced our lead product candidatetoward becoming a promising commercial product opportunity in a market that isin need of safe and effective new antibiotics. With the establishment of ourWyeth partnership in the Asia Pacific region, we have laid the cornerstone ofour global commercialization strategy. In addition, the awarding of our multi-million dollar Defense Threat Reduction Agency (DTRA) contract is indicativeof the potential for cethromycin and the significant market opportunity in thebiodefense field."
Continued Dr. Flavin: "As we look forward to the July 31, 2009, PDUFA dateset by FDA for cethromycin, we are realigning our resources and cost structureto focus on our upcoming commercial objectives and intend to raise capital tostrengthen our financial position."
Financial Guidance for 2009
Advanced Life Sciences expects its 2009 cash requirements, excludingmilestone payments that become due upon cethromycin NDA approval, to fall inthe range of $12.0 million and $15.0 million. Cash use in the first quarterof 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, thefollowing initiatives are being undertaken to conserve capital and strengthenthe balance sheet:
Nasdaq Marketplace Rule 4350(b)(1)(B)
The Company's independent registered public accounting firm included anexplanatory paragraph in its report on the Company's 2008 financial statementsrelated to uncertainty in the Company's ability to continue as a goingconcern. We anticipate that our independent registered public accounting firmwill include a similar opinion in its report on the Company's 2008 financialstatements. There can be no assurance that it will be able to secure acommercial partnership or obtain adequate capital funding in the future tocontinue operations and implement its strategy, which would have an adverseeffect on the Company's business and operations.
Conference Call Details
Advanced Life Sciences will host a conference call and live webcast at10:00 a.m. Eastern Time on Wednesday, February 11, 2009 to discuss theCompany's financial results for the fourth quarter and full year endedDecember 31, 2008.
The conference call will be webcast simultaneously over the Internet.Please visit the Investor Relations section of the Advanced Life Sciencescorporate website http://www.advancedlifesciences.com. Alternatively, callersmay participate in the conference call by dialing 888-680-0879 or 617-213-4856(international). The passcode for the conference call is 25253515. A replayof the conference call will be available until February 18, 2009. Callers mayaccess the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888(international), passcode 89150902. Investors are advised to dial into thecall at least ten minutes prior to the call to register. Participants may pre-register for the call athttps://www.theconferencingservice.com/prereg/key.process?key=PNXL8438C. Pre-registrants will be issued a pin number to use when dialing into the live callwhich will provide quick access to the conference by bypassing the operatorupon connection.
About Community Acquired Pneumonia (CAP)
CAP is the sixth most common cause of death in the United States. CAP andother respiratory tract infections are caused by pathogens such asStreptococcus pneumoniae and Haemophilus influenzae. Approximately 5.6million cases of CAP are diagnosed each year in the United States with 10million physician visits, resulting in an estimated total annual expenditureof $2.0 billion dollars for prescribed antibiotics to treat CAP. CAP ispotentially fatal if not treated properly, and the bacteria that cause CAP aredeveloping resistance to current standard of care treatments.
Macrolides and penicillins are currently the front-line treatments forrespiratory tract infections such as CAP. As macrolide and penicillinresistance grows and has the potential to cause more clinical failures, thereis a need for new antibiotics with unique mechanisms of action that canovercome this emerging resistance.
About Cethromycin
Cethromycin has shown higher in vitro potency and a broader range ofactivity than macrolides against Gram-positive bacteria associated withrespiratory tract infections, and, again in in vitro tests, it appears to beeffective against penicillin- and macrolide-resistant bacteria. Cethromycinhas a mechanism of action that may slow the onset of future bacterialresistance. In addition to its utility in CAP, cethromycin is also beinginvestigated for the prophylactic treatment of inhalation anthrax post-exposure. The FDA has designated cethromycin as an orphan drug for theprophylactic treatment of inhalation anthrax post exposure, but the drug isnot yet approved for this or any other indication.
About Advanced Life Sciences
Advanced Life Sciences is a biopharmaceutical company engaged in thediscovery, development and commercialization of novel drugs in the therapeuticareas of infection, cancer and inflammation. The Company's lead candidate,cethromycin, is a novel once-a-day oral antibiotic under review by the FDA forthe treatment of mild-to-moderate community acquired pneumonia. For moreinformation, please visit us on the web athttp://www.advancedlifesciences.com.
Forward-Looking Statements
Any statements contained in this press release that relate to futureplans, events or performance are forward-looking statements within the meaningof the Private Securities Litigation Reform Act of 1995. Forward-lookingstatements represent our management's judgment regarding future events. TheCompany does not undertake any obligations to update any forward-lookingstatements whether as a result of new information, future events or otherwise.Our actual results could differ materially from those discussed herein due toseveral factors including the success and timing of our clinical trials andour ability to obtain and maintain regulatory approval and labeling of ourproduct candidates; our plans to develop and commercialize our productcandidates; the loss of key scientific or management personnel; the size andgrowth of potential markets for our product candidates and our ability toserve those markets; regulatory developments in the U.S. and foreigncountries; the rate and degree of market acceptance of any future products;the accuracy of our estimates regarding expenses, future revenues and capitalrequirements; our ability to obtain financing on terms acceptable to us; ourability to obtain and maintain intellectual property protection for ourproduct candidates; the successful development of our sales and marketingcapabilities; the success of competing drugs that become available; and theperformance of third party collaborators and manufacturers. These andadditional risks and uncertainties are detailed in the Company's filings withthe Securities and Exchange Commission.Operating Expense Analysis: 2008 versus 2007: * Research and development expense. Total research and development expense decreased $10.0 million to approximately $15.7 million for the year ended December 31, 2008 from approximately $25.7 million for the year ended December 31, 2007. The decrease in R&D expense is related to the conclusion of clinical trials and development costs associated with the Company's lead product, cethromycin. * General and administrative expense. General and administrative expense increased $0.3 million to $7.1 million for the year ended December 31, 2008. Fourth Quarter Expense Analysis: 2008 versus 2007: * Research and development expense. Total research and development expense decreased $3.1 million to approximately $0.9 million for the three months ended December 31, 2008 from approximately $4.0 million for the three months ended December 31, 2007. This decrease reflects a reduction in development expenses associated with the completion of clinical trials for cethromycin. * General and administrative expense. General and administrative expense increased $0.4 million to $1.9 million for the three months ended December 31, 2008. This increase reflects costs incurred for pre-commercial activities. 2008 Achievements * The successful submission and filing of the NDA to the U.S. Food and Drug Administration (FDA) for cethromycin in the treatment of mild- to-moderate community acquired pneumonia (CAP); * The signing of a development and commercialization agreement with Wyeth in the Asia Pacific region (excluding Japan), which includes a substantial up-front equity investment as well as milestones and payments based on successful achievement of clinical, regulatory and commercial objectives in specific markets that could potentially exceed $100 million; * The awarding of a DTRA biodefense contract valued at up to $3.8 million to fund the advanced development of cethromycin as a potential broad-spectrum medical countermeasure against bioterror agents such as tularemia, plague and melioidosis; * Establishment of a strategic relationship with Inventiv Health to support pre-commercialization activities; * The completion of a debt transaction increasing our bank line of credit from $4.0 million to $10.0 million to strengthen our balance sheet and help fund commitments associated with our cethromycin NDA submission and pre-commercialization activities; * The implementation of a Standby Equity Distribution Agreement (SEDA) with YA Global Investments, L.P. for the sale of up to $15 million of shares of our common stock over a two-year period; * The publication of a research article in the Journal of Antimicrobial Chemotherapy supporting the additional role for cethromycin as a potential treatment for infections caused by community associated methicillin resistant Staphylococcus aureus (CA-MRSA) as well as presentation of clinical and microbiological data in posters and an oral presentation pertaining to cethromycin at the 48th Annual ICAAC/IDSA Meeting. Cethromycin Objectives for 2009 * Advance discussions with prospective U.S. and E.U. partners for the commercialization of cethromycin; * Initiate clinical trials with Wyeth in the Asia Pacific region in the moderate CAP patient population to support commercialization and build on our regulatory package; * Continue supplemental NDA enabling studies of cethromycin as a broad spectrum biodefense countermeasure under the DTRA contract; * Continue pre-launch activities including manufacturing, strategic marketing, medical education, pricing and reimbursement strategies.
SOURCE Advanced Life Sciences Holdings, Inc.
