…Cash Position Increases / GMP Manufacturing Capabilities Acquired
Philadelphia, PA, Friday, May 14, 2004: HEMISPHERX BIOPHARMA
FIRST QUARTER 2004 EARNINGS ANNOUNCED
….Cash Position Increases / GMP Manufacturing Capabilities Acquired
Philadelphia, PA, May 14, 2004 – Hemispherx Biopharma, Inc. (AMEX: HEB) announced a loss (including non-cash expenses) for the three months ended March 31, 2004 of $8,042,000 or $0.20 per share compared to losses of $1,617,000 or $0.05 per share for the same period in 2003. This year-to-year loss increase of $6,425,000 is primarily due to non-cash financing costs of $3,851,000 relating to the July, October and January 2004 6% convertible debentures as well as a non-cash stock compensation charge of $1,769,000 resulting from warrants issued in 2003 that vested in the current quarter. These two factors represent 70% of our net loss for the three months ended March 31, 2004. For comparative purposes, excluding our March 31, 2004 losses from these two factors, our losses were $2,422,000 for the three months ended March 31, 2004 compared to $1,559,000 for the same period in 2003 or an increase of approximately $863,000. Revenues were up $242,000 (366%) due to increased sales of Alferon N Injection, offset by increased 1) Alferon division losses of $436,000 2) R&D cost of $103,000 3) G&A cost of $201,000 basically due to legal, accounting and other fees related to the recent acquisition and related debenture financing, and 4) a net of $123,000 increase in other miscellaneous expenses.
Cash and cash equivalents and short-term investments were increased approximately $1,979,000 or 38% and property and equipment increased $3,293,000, during the current quarter. Cash, cash equivalents and short term investments were $7,238,000 as of March 31, 2004. Subsequent to March 31, 2004, additional warrant conversions by the debenture holders resulted in gross proceeds to the company of approximately $2,400,000. The increase in property (GMP certified manufacturing plants) and related manufacturing equipment during the current quarter was the result of completing the acquisition of all of the worldwide rights of Alferon N as well as the FDA approved biological production facility in the New Brunswick, New Jersey on March 17, 2004.
The Company also recently completed the well-controlled, double-blind segment of it’s pivotal ME/CFS Phase III clinical trial for potential use of the experimental immunotherapeutic compound, Ampligen® in the treatment of ME/CFS. Clinical data on the primary endpoint from this study were presented at the 17th International Conference on Anti-Viral Research in Tucson, AZ on May 3, 2004. These data indicate that at the end of the 40-week study, Ampligen improved the primary clinical endpoint by a medically and statistically significant amount compared to placebo. Ampligen is also currently in Phase IIb for treatment of HIV to overcome multi-drug resistance, virus mutation and toxicity associated with current HAART therapies.
Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of viral and immune-based chronic disorders. Its flagship products include Alferon and the experimental immunotherapeutics/antivirals Ampligen and Oragens. These novel proteins, approved for a category of STD infection, and experimental nucleic acids are being developed for globally important chronic viral diseases and disorders of the immune system including HPV, HIV, CFS, Hepatitis and SARS. Its platform technology includes large and small agent components for potential treatment of various chronic viral infections. Hemispherx has approximately 250 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N) and GMP certified manufacturing facilities for its novel pharma product. For more information please visit www.hemispherx.net
Hemispherx Biopharma, Inc.,
Dianne Will, Investor Relations
(518) 398-6222, Fax: (518) 398-6369
HEB's Web Site: 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 Oragens) 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. Clinical trials for other potential indications of the approved biologic Alferon do not imply that the product will ever be specifically approved commercially for these other treatment indications including SARS. The Alferon® asset for overseas sales for a category of STD is currently being acquired by the Company as part of a multi-step purchase contract of inventory, intellectual property, commercial licenses and GMP approved facilities, which house the biological operations.