Inhibitex announces net loss of $4.7M for fourth-quarter 2009

Mar 23 2010

Inhibitex, Inc. (NASDAQ:INHX) today announced its financial results for the fourth quarter and year ended December 31, 2009 and provided an update on various corporate developments.

“We are proud of our many accomplishments in 2009 and enter 2010 well-positioned for what we believe will be a transformational year for Inhibitex”

“We are proud of our many accomplishments in 2009 and enter 2010 well-positioned for what we believe will be a transformational year for Inhibitex,” stated Russell H. Plumb, President and CEO of Inhibitex, Inc. “Our Phase II trial of FV-100, which we are developing for the treatment of shingles, passed the midway point in enrollment last month. Pfizer recently advanced a staphylococcal vaccine that contains one of our proprietary antigens into clinical development. We anticipate that INX-189, a nucleotide polymerase inhibitor that we are developing to treat chronic hepatitis C infections, will also enter clinical development in the first half of this year. Over the next twelve months, we intend to complete human proof-of-concept trials for both FV-100 and INX-189. Finally, due to a $23 million financing transaction in the fourth quarter of 2009, we believe that we are adequately funded to achieve these near-term development goals and support our planned operations into 2012.”

Fourth Quarter 2009 Financial Results

As of December 31, 2009, the Company held $37.9 million in cash, cash equivalents and short-term investments. The Company had a net loss for the fourth quarter of 2009 of $4.7 million, as compared to a net loss of $3.5 million in the fourth quarter of 2008. Basic and diluted net loss per share was $0.08 for the fourth quarter of both 2009 and 2008. The increase in net loss in the fourth quarter of 2009 was the result of higher research and development expense, lower revenues from a collaborative license and development agreement and lower net interest income, offset in part by a reduction in general and administrative expense.

Revenue decreased to $0.3 million in the fourth quarter of 2009 from $0.8 million in the fourth quarter of 2008. The $0.5 million decrease was primarily the result of upfront license fees received by the Company in 2007 and 2008 being fully amortized to revenue as of the end of 2008, and to a lesser extent, lower periodic research-associated support fees received by the Company in 2009.

Research and development expense increased to $4.3 million in the fourth quarter of 2009 from $3.6 million in the fourth quarter of 2008, primarily due to a $0.9 million increase in direct costs incurred in connection with the clinical development of FV-100 and the preclinical development of INX-189, offset in part by a $0.2 million decrease in non-direct expenses.

General and administrative expense decreased to $0.7 million in the fourth quarter of 2009 from $1.0 million in the fourth quarter of 2008. The decrease of $0.3 million was primarily the result of a reduction in insurance premiums and other various recurring expenses.

Year End 2009 Financial Results

For the year ended December 31, 2009, the Company reported a net loss of $17.6 million, as compared to $13.2 million for 2008. Basic and diluted net loss per share for the year ended December 31, 2009 was $0.38, as compared to $0.31 for 2008. The increase in net loss and net loss per share in 2009 was primarily the result of higher research and development expense associated with the clinical development of FV-100 and the preclinical development of the Company’s HCV nucleotide polymerase inhibitor program, including INX-189, lower revenues from a collaborative license and development agreement and lower net interest income, offset in part by a reduction in general and administrative expense.

Recent Corporate Developments

FV-100- In January 2010, the Company announced that the independent Data Safety Monitoring Board (DSMB) responsible for reviewing data from the Company’s ongoing Phase II clinical trial of FV-100 met, as scheduled, in early December 2009 after the Company had provided it with complete 30-day follow-up data on the first quartile of patients enrolled in the trial. Based upon its review, the DSMB unanimously recommended that the trial should continue, as originally designed, without modification. The Company anticipates that an interim analysis and a DSMB review of the complete 30-day follow-up data on the first half (50%) of patients enrolled in the trial will be completed shortly. Top-line data from this trial is anticipated in the fourth quarter of 2010.

INX-189- In January 2010, the Company announced it had completed the requisite Good Laboratory Practices (GLP) preclinical studies to support the filing of an investigational new drug application (IND) for INX-189. Based on the results of these studies, an IND and, subject to FDA review, initiation of a Phase I clinical trial of INX-189, continue to be anticipated in the first half of 2010.

Staphylococcal Vaccine - In January 2010, the Company announced that its licensee and collaborator, Pfizer, Inc., had initiated recruitment for a randomized, double-blind Phase I clinical trial to evaluate the safety, tolerability, and immunogenicity of three ascending dose levels of a 3-antigen Staphylococcus aureus (S. aureus) vaccine (SA3Ag) in 408 healthy adults. The vaccine contains an antigen originating from the Company’s proprietary MSCRAMM^® protein platform. Pfizer is responsible for all clinical development, manufacturing and marketing of the vaccine. The Company received a payment of $0.7 million upon the achievement of this milestone and is eligible to receive future regulatory milestones, as well as royalties on any future net sales.

Financial Guidance

The Company provided financial guidance for 2010 based upon the status of its development programs and its clinical development plans for FV-100 and INX-189. The Company currently anticipates that it will have between $14-$15 million in cash, cash equivalents and short-term investments on hand at the end of 2010, and that it has sufficient financial resources to support its planned operations into 2012. This guidance assumes that the Company completes its ongoing Phase II proof of concept trial of FV-100 in 2010 and completes Phase I clinical trials of INX-189 as planned. This estimate does not include the direct costs associated with continuing the clinical development of FV-100 or INX-189 beyond these ongoing or planned clinical trials, or the impact of any other significant transaction or change in strategy or development plans in the future.