BioCryst Reports Third Quarter 2008 Financial Results and Provides Corporate Update
Friday October 31, 7:30 am ET
BIRMINGHAM, Ala., Oct. 31 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX - News) today announced financial results for the quarter ended September 30, 2008.
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Third Quarter 2008 Financial Results
For the three months ended September 30, 2008, the Company reported collaborative and other research and development revenues of $8.9 million compared to $20.5 million for the three months ended September 30, 2007. This decrease is driven by a reduction in peramivir clinical development costs and associated revenue from the contract with the U.S. Department of Health and Human Services (HHS) for the development of peramivir. Currently, the majority of the Company's revenues are derived from the reimbursement of costs under the contract with HHS.
Research and development (R&D) expenses were $16.0 million for the three months ended September 30, 2008, compared to $29.7 million for the three months ended September 30, 2007. The decrease in R&D expenses is primarily attributable to a reduction in clinical development costs associated with the peramivir program, a reduction in manufacturing costs associated with both the peramivir and forodesine HCl program and a reduction in costs incurred related to the Company's preclinical programs. These reductions were partially offset by an increase in BioCryst's clinical development costs in the forodesine HCl program.
General and administrative (G&A) expenses were $2.5 million for the three months ended September 30, 2008, compared to $2.6 million for the three months ended September 30, 2007.
The net loss for the quarter ended September 30, 2008 was $9.0 million, or $0.24 per share, compared to a net loss for the quarter ended September 30, 2007 of $11.0 million or $0.32 per share.
As of September 30, 2008, the Company held cash, cash equivalents and investments of $67.9 million.
Year-to-Date 2008 Financial Results
Collaborative and other research and development revenues were $22.3 million for the nine months ended September 30, 2008, compared to $43.1 million for the nine months ended September 30, 2007. This decrease is driven by a reduction in peramivir related clinical development costs leading to a reduction in costs and associated revenue from HHS, plus the $4.9 million reserve taken in the second quarter of 2008 for amounts BioCryst previously expected to receive from HHS related to costs incurred in the Phase 3 program in intramuscular peramivir for outpatient influenza. These costs were associated with the Phase 3 program for peramivir that was voluntarily discontinued earlier this year and reimbursement of these costs is under discussion with HHS.
R&D expenses were $51.3 million for the nine months ended September 30, 2008, compared to $64.9 million for the nine months ended September 30, 2007. The decrease in R&D expenses is due to a reduction in the clinical development costs and toxicology costs associated with the peramivir program and a reduction in manufacturing costs associated with both the peramivir and forodesine HCl programs. These reductions were partially offset by an increase in the Company's clinical development costs for forodesine HCl and increases in personnel related costs and professional services.
G&A expenses were $8.0 million for the nine months ended September 30, 2008, compared to $7.0 million for the nine months ended September 30, 2007. The higher expenses were primarily due to an increase in professional fees and personnel related costs.
The net loss for the nine months ended September 30, 2008 was $34.8 million, or $0.91 per share, compared to a net loss for the nine months ended September 30, 2007 of $26.8 million or $0.86 per share.
"As a result of prudent cash control, we reconfirm that the cash burn for the year ended December 31, 2008 will remain at the lower end of $25 to $30 million guidance provided earlier this year," said Stuart Grant, BioCryst's Chief Financial Officer. "We have implemented strategic initiatives, including a recent 20 percent reduction in our workforce, to focus the Company's resources on the execution of our late-stage clinical trials and the development of our most promising pre-clinical compounds. We have full funding of our peramivir program through Phase 2 clinical trials from HHS and a strong cash position that will allow us to execute on our plan without depending on the capital markets."
"We have recently made significant advancements in our clinical programs and are encouraged by the positive peramivir efficacy data reported in the Phase 2 study we conducted in subjects with influenza requiring hospitalization, and the Phase 2 study in subjects with acute uncomplicated influenza conducted by our partner, Shionogi & Co., Ltd.," said Jon Stonehouse, President and Chief Executive Officer of BioCryst. "Over the next year, we have several key value-driving milestones for both our peramivir and PNP programs and remain committed to advancing our products towards market."
Corporate Update
A poster entitled "A Double-Blind, Placebo-Controlled Study of Intravenous Peramivir in Acute Influenza Patients" was presented at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), detailing the results of a Shionogi & Co., Ltd.-sponsored, placebo-controlled, Phase 2 study of intravenous (i.v.) peramivir, a neuraminidase inhibitor, in outpatients with acute, uncomplicated influenza. The study met its primary endpoint of time to alleviation of symptoms for both the 300 mg dose (p=0.0046) and 600 mg dose (p=0.0046) (hazard ratios were 0.681 for 300 mg dose and 0.666 for the 600 mg dose). The median time to alleviation of symptoms was 59.1 hours for those receiving the 300 mg dose, 59.9 hours for those receiving the 600 mg dose and 81.8 hours for those receiving placebo. The study also met all secondary endpoints. Peramivir was generally well-tolerated in the study, with a similar adverse event profile to that of placebo. Shionogi is currently preparing to initiate a Phase 3 program with i.v. peramivir in the outpatient setting.
BioCryst reported results of an exploratory Phase 2 trial of i.v. peramivir in subjects hospitalized for acute serious or potentially life-threatening influenza. The Phase 2 trial compared the efficacy and safety of five days of therapy with either 200 mg i.v. peramivir per day, 400 mg i.v. peramivir per day or 75 mg oral oseltamivir twice a day, in subjects who required hospitalization related to influenza. The primary objective of the study was to evaluate a novel composite endpoint, time to clinical stability, which is comprised of normalization of temperature, oxygen saturation, respiratory rate, systolic blood pressure and heart rate. Secondary objectives of the study included evaluation of viral shedding, mortality, clinical relapse and time to resumption of usual activities. In the primary efficacy population, for all groups combined, the study demonstrated a median of 25.3 hours to clinical stability, a median of 2.0 log reduction in time weighted change from baseline in viral titer, zero mortality, no clinical relapse and a median of 10.8 days of time to resumption of usual activities. There were no statistically significant differences in any of the efficacy endpoints between the three treatment arms. Peramivir was generally safe and well-tolerated at these dose levels. Detailed results will be submitted to an upcoming medical meeting.
BioCryst reported top-line results from the completed Phase 2a trial of BCX-4208 in subjects with moderate to severe plaque psoriasis were consistent with interim findings. BCX-4208, a potent, rationally designed, orally available purine nucleoside phosphorylase inhibitor, met its primary endpoint of safety and tolerability and displayed dose-dependant reductions in peripheral blood lymphocyte counts. The pharmacokinetic and pharmacodynamic results suggest that BCX-4208 may have utility in diseases dependant on T-cells, B-cells or uric acid. The Phase 2a results have been accepted for presentation at the 50th American Society of Hematology Annual Meeting and Exposition (ASH), which will be held in San Francisco, December 6-9, 2008.
The forodesine HCl pivotal trial in cutaneous T-cell lymphoma (CTCL) continues to enroll subjects with CTCL stages IIB through IVA who have failed three systemic therapies. The multinational study is evaluating once daily oral forodesine HCL treatment and is being conducted in accordance with a Special Protocol Assessment agreement between the U.S. Food and Drug Administration and BioCryst. A laboratory study of forodesine HCl in leukemia cells has been accepted for presentation at ASH.
Conference Call and Web cast
BioCryst's management team will host a conference call and Web cast on Friday, October 31, 2008, at 8:30 a.m. Eastern Time to discuss the financial results and recent developments within the Company's programs. To participate in the conference call, please dial 1-800-860-2442 (United States) or 1-412-858-4600 (International). No passcode is needed for the call. The Web cast can be accessed by logging onto biocryst.com. Please connect to the Web site at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be necessary.
About BioCryst
BioCryst is an integrated biopharmaceutical company utilizing crystallography and structure-based drug design to develop a deep pipeline of novel therapeutics targeting major illnesses. BioCryst is currently advancing investigational new drugs discovered in-house in late-stage clinical trials for influenza and lymphoma. In addition, the Company has a pre-clinical portfolio of novel compounds, directed against infectious, cardiovascular, and autoimmune disease targets, to create long-term sustainable value. The Company's strategic alliances with the U.S. Department of Health and Human Services, Shionogi & Co., Ltd., Green Cross Corporation and Mundipharma International Holdings Ltd. validate its scientific foundation and the utility of its product candidates. For more information, please visit the Company's Web site at www.biocryst.com. |
