BIOCRYST REPORTS THIRD QUARTER 2001 FINANCIAL RESULTS
Net income for the quarter ended September 30, 2001 was $417,000, or $0.02 per diluted share, compared to a net loss of $980,000, or $0.06 per share, for the same period last year. As of September 30, 2001, the Company had cash, cash equivalents and investments of $57.0 million.
Revenues for the nine months ended September 30, 2001 were $10,554,000, compared to $5,736,000 for the nine months ended September 30, 2000. The net loss for the nine months ended September 30, 2001 was $8,000, or $0.00 per share, compared to a net loss of $3,648,000, or $0.21 per share, for the same period last year. After the cumulative effect adjustment required by SAB 101, the net loss for the nine months ended September 30, 2000 was $9,736,000, or $0.56 per share. The increase in revenues in the first nine months of 2001 was primarily due to the change in accounting estimate following Ortho-McNeil and RWJPRI's termination of the agreement with BioCryst.
During the quarter, BioCryst continued preparations to move forward in the United States and complete a Phase III clinical trial of once-a-day orally administered RWJ-270201 that was initiated in February 2000 in Europe. Following discussions with the U. S. Food and Drug Administration (FDA) in August, BioCryst is planning to initiate a multicenter, Phase III clinical trial to assess the safety and efficacy of RWJ-270201 to treat viral influenza in patients during the 2001-2002 flu season in the United States.
In addition, during the quarter, the license agreement to develop and market products to treat and prevent viral influenza was officially terminated by BioCryst, Ortho-McNeil and RWJPRI. Ortho-McNeil indicated that this business decision was not related to safety or efficacy of the drug, but that other of its drug development programs were of a higher priority. Meanwhile, BioCryst is seeking a new corporate partner to facilitate the final development and potential commercialization of RWJ-270201.
The Company will sponsor a conference call at 10:00 am EDT on Wednesday, October 24, which is open to the public. Interested investors can listen to the call live over the Internet from the investor relations website at www.biocryst.com or http://www.videonewswire.com/event.asp?id=1566 or by dialing 1-800-946-0715, and providing the passcode number 460813.
Founded in 1986, BioCryst Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development of pharmaceuticals for the treatment of viral, inflammatory/autoimmune and cardiovascular diseases and disorders. BioCryst's most advanced drug candidate, RWJ-270201 (formerly known as BCX-1812), is a neuraminidase inhibitor designed to treat and prevent viral influenza.
These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, BioCryst's plan to move forward with Phase III development of RWJ-270201; BioCryst's ability to obtain a corporate partner to continue development and potential commercialization on acceptable terms, if at all; progress with respect to continuing Phase III development; and developments with respect to clinical trials and the regulatory approval process. Even if BioCryst continues certain Phase III clinical trials of RWJ-270201, we do not know when, if ever, it will complete all the required Phase III clinical trials, or when, if ever, it will receive FDA or foreign regulatory agency approvals for, or when, if ever, marketing of RWJ-270201 will begin. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include, without limitation, that the Company may not be able to: (i) continue Phase III or future development of RWJ-270201, (ii) license our proprietary influenza neuraminidase inhibitor, RWJ-270201, to a new corporate partner to facilitate final development and potential commercialization, (iii) complete an agreement with such a corporate partner on favorable terms or at all, or (iv) continue research and testing of our RWJ-270201. In addition, the Company can give no assurance as to timing by which an agreement may be signed, or that an agreement will result in future milestone or royalty payments, products may be cleared for marketing, that RWJ-270201 will be safe or effective, that required regulatory clearances can be obtained from the U.S. Food and Drug Administration or foreign regulatory authorities. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst's most recent Annual Report on Form 10-K, which identifies important factors that could cause the actual results to differ materially from those contained in the projections or forward-looking statements.
