PHILADELPHIA, March 14, 2012 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE Amex:HEB) announced its financial results for the fiscal year ended December 31, 2011. The net loss for 2011's twelve month period (including non-cash effects) was approximately $9,015,000 or $(0.07) per share as compared to a net loss of $13,136,000 or ($0.10) per share for the same period in 2010. This year-to-year decrease in net loss of $4,121,000 (31%) was impacted by the fair value revaluation of the estimated liability related to certain redeemable warrants resulting in a non-cash gain of $2,425,000 in 2011, as compared to a non-cash gain of $879,000 in 2010.
If the non-cash effect of the required revaluation of the estimated liability related to certain redeemable warrants were excluded from the financial results, the resultant net loss for the twelve month period of 2011 would be approximately $11,440,000 as compared to a net loss of $14,015,000 for the same period in 2010, resulting in a net loss decrease of approximately $2,575,000 or 18%. The favorable variance between 2011 and 2010 was contributed to by a decrease of operating expenses for $2,066,000 and sale of tax net operating losses for $2,272,000, partially offset with a reduction of $1,759,000 in interest income.
Cash, cash equivalents and marketable securities were approximately $34,391,000 as of December 31, 2011. Net cash used in operating activities for the twelve months ended December 31, 2011 was $10,096,000 compared to $11,886,000 for the same period in 2010, a decrease of $1,790,000 or 15%.
We own and operate a 43,000 sq. ft. Federal Drug Administration (FDA) approved facility in New Brunswick, NJ that is designed to produce Alferon®, and Ampligen®. Alferon N Injection® is an FDA approved commercial product and Ampligen® is an experimental product in advanced clinical testing. In December 2011, our Board of Directors reevaluated its enhancement project to focus on converting this facility to provide for a high volume, cost effective manufacturing process for three products: Alferon N Injection®, Alferon® LDO (a low does oral form of Alferon®) and Ampligen®. In this regard, the Board approved an increase in the project commitment from $4.4 million to $6.5 million. The project is now in an active construction phase with approximately $1,695,000 spent to-date and financed through a Margin Account Loan with an effective interest rate of 2.75%. The Company has actively pursued cost savings, including the location and acquisition of equipment from major U.S. pharmaceutical manufacturers that have recently curtailed or eliminated certain manufacturing activities in the U.S. As a result, Management estimates a cost savings on equipment purchased of approximately $827,000 for the project to date.
In January 2012, Hemispherx requested from the FDA an additional extension to file a response to the Complete Response Letter regarding its pending Ampligen New Drug Application (NDA) which was thereafter granted. The Company is currently conducting an open-label treatment protocol in the U.S. for the potential treatment of Chronic Fatigue Syndrome (CFS). We believe that continued efforts to understand existing clinical and preclinical data, coupled with the development of new data, will ultimately support a re-filing of an amended NDA. Thus, the Company is pursuing the filing of an amended NDA in response to FDA comments in the Complete Response Letter of November 25, 2009.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen® and Alferon® LDO) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. The planning, completion, results or submission of clinical trials do not imply that any study product will ever be approved commercially for the studied or other treatment indications.