BioCryst Pharmaceuticals reports fiscal 2009 third-quarter results

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced financial results for the quarter and nine months ended September 30, 2009 and provided a corporate update regarding clinical programs and potential emergency use of intravenous (i.v.) peramivir.

"BioCryst has made significant progress in its efforts to enable the U.S. and other governments to acquire i.v. peramivir for use as a potential treatment option during this influenza emergency. The recent Emergency Use Authorization, or EUA, issued by the FDA, was an important milestone. BioCryst is prepared to provide peramivir if requested by the U.S. and other governments," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst Pharmaceuticals. "BioCryst remains committed to completing the U.S. development of peramivir through the traditional regulatory pathway."

"In recent months we have advanced BioCryst's clinical pipeline by starting Phase 3 studies to support U.S. registration of i.v. peramivir and by initiating a Phase 2 study of BCX4208 in patients with gout," said Dr. William P. Sheridan, Chief Medical Officer at BioCryst. "Additionally, we are in the process of completing a portfolio review of our clinical and pre-clinical programs and molecules so that we can optimize our development plan for the mid-term."

Third Quarter Financial Results

For the three months ended September 30, 2009, collaborative and other research and development (R&D) revenues were $10.5 million compared to $8.9 million for the three months ended September 30, 2008. This increase was the result of higher revenues from our contract with the Department of Health and Human Services (HHS) for the development of peramivir and from our collaboration with Shionogi & Co., Ltd. These increases in revenues were offset by a reduction in revenue from our collaboration with Mundipharma International Holdings Limited, as well as lower amortization of deferred revenue from our collaboration arrangements.

R&D expenses increased to $18.2 million for the third quarter of 2009 from $16.0 million for the third quarter of 2008. The higher R&D expenses resulted from an increase in manufacturing costs associated with our peramivir program, offset by reductions in clinical development costs for our peramivir and forodesine programs. In addition, general operating costs as well as personnel related costs were lower in the current quarter of 2009 compared to the same quarter of the prior year.

General and administrative (G&A) expenses increased to $3.1 million for the third quarter of 2009 from $2.5 million for last year's third quarter, primarily due to increases in legal and consulting fees.

Interest income for the third quarter 2009 was $0.1 million as compared to $0.6 million for the same period last year. The decrease was driven by a lower average cash and securities balance as well as a significantly lower yield earned on interest-bearing assets.

The net loss for the third quarter of 2009 was $10.6 million, or $0.28 per share, compared to a net loss of $9.0 million, or $0.24 per share for the third quarter of 2008.

As of September 30, 2009, the Company held cash, cash equivalents and investments of $38.5 million, a decrease of $3.8 million during the third quarter of 2009. This reduction is net of $5.0 million that was returned by HHS relative to the purchase of excess active pharmaceutical ingredient (API). In July 2009, BioCryst indicated that it was in the process of purchasing excess peramivir API from HHS as permitted under the development contract. HHS is completing its review of this excess in light of the peramivir clinical development plan, as well as the calculation for the acquisition cost for the purchase. Pending completion of that review, HHS has returned the payment to BioCryst. HHS acknowledges that at least half of the API is excess. When HHS has completed its review, we will determine the final acquisition process for the API.