BioCryst 2010 third quarter revenue increases from $10.5 million to $12.0 million

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced financial results for the third quarter and nine months ended September 30, 2010.

“We are making strong progress in building BioCryst towards sustainability, on a foundation of new product approvals, advances in key development programs and emerging opportunities from our discovery engine”

Recent Highlights

• BioCryst's partner Shionogi & Co., Ltd. received approval for an additional indication for use of intravenous (i.v.) peramivir to treat children and infants with influenza in Japan, where it is marketed under the commercial name RAPIACTA^®.
• In August, Green Cross Corporation received regulatory approval for i.v. peramivir under the commercial name PeramiFlu^® in Korea to treat patients with influenza.
• In September, BioCryst announced positive results from its Phase 2 study of BCX4208 alone and in combination with allopurinol for the treatment of gout. Lower doses of BCX4208 combined with allopurinol demonstrated synergistic effects in serum uric acid (sUA) reduction.
• In September, BioCryst reported results from two oral forodesine studies which demonstrated its clinical activity against cutaneous T-cell lymphoma (CTCL) and chronic lymphocytic leukemia (CLL).

"We are making strong progress in building BioCryst towards sustainability, on a foundation of new product approvals, advances in key development programs and emerging opportunities from our discovery engine," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst Pharmaceuticals. "The market authorizations obtained by our partners, the advancement of the gout program and the decision to move forward with BCX4161 as a potential novel treatment for hereditary angioedema all enhance our ability to create value over the short- and long-term."

Third Quarter Financial Results

For the three months ended September 30, 2010, total revenues increased to $12.0 million compared to $10.5 million for the three months ended September 30, 2009. This $1.5 million increase was driven by higher revenue from the contract with the Department of Health & Human Services (HHS) for the continued development of i.v. peramivir, offset by lower revenue from the Company's collaboration with Shionogi & Co., Ltd.

Research and development (R&D) expenses increased to $19.2 million for the third quarter of 2010 from $18.2 million in the same quarter of last year. This increase was driven by higher development costs of $2.8 million associated with the BCX4208 program for the treatment of gout, partially offset by decreases in development costs of $1.9 million associated with the forodesine and peramivir clinical programs.

General and administrative (G&A) expenses increased to $3.8 million for the third quarter of 2010 from $3.1 million in the same quarter as last year. This increase was primarily due to higher consulting fees and personnel related costs.

The Company's net loss for the three months ended September 30, 2010 was $10.9 million, or $0.24 per share, compared to a net loss of $10.6 million, or $0.28 per share for the three months ended September 30, 2009.

Year to Date Financial Results

For the nine months ended September 30, 2010, total revenues increased to $45.7 million compared to $19.7 million for the nine months ended September 30, 2009. This $26.0 million increase was driven primarily by a $12.4 million increase in revenue from the contract with HHS, as well as the receipt of a $7.0 million milestone payment from the Company's partner, Shionogi and the sale of $6.4 million of peramivir active pharmaceutical ingredient (API) to collaborators Shionogi and Green Cross Corp. during the first quarter 2010.

R&D expenses increased to $58.9 million for the first nine months of 2010 from $40.7 million in the same period as last year. The $18.2 million increase was primarily due to an increase of $6.5 million in development costs associated with the peramivir program, $6.3 million of manufacturing costs related to production of peramivir API for Shionogi and Green Cross Corp., $6.3 million in higher development costs associated with the BCX4208 program and $1.0 million in higher pre-clinical program costs. These increases in R&D expenses were partially offset by a decrease of $2.1 million in development costs associated with the forodesine program.

G&A expenses increased to $10.8 million for the nine months ended September 30, 2010 from $7.8 million for the nine months ended September 30, 2009, primarily due to increases in consulting fees and personnel related costs.

The net loss for the nine months ended September 30, 2010 was $23.7 million, or $0.53 per share, compared to a net loss of $28.6 million, or $0.75 per share for the nine months ended September 30, 2009.

As of September 30, 2010, the Company held cash, cash equivalents and securities of $72.0 million, a decrease of $22.2 million as compared to December 31, 2009.

During the August 2010 quarterly update, we projected 2010 cash use to be within, but at the high end of its previous guidance range of $25 to $30 million. Initiation of the modified Phase 3 program for peramivir will lead to a ramp up in development expenses during the fourth quarter of 2010. This creates a timing effect on our 2010 cash use, as these expenses will be reimbursed by HHS during the first quarter of 2011. As a result, we now expect our cash use for 2010 to be approximately $33 million.

Clinical Development Update & Outlook

• The Phase 2 study to evaluate the efficacy and safety of BCX4208 alone and in combination with allopurinol in gout patients met its primary endpoint related to sUA reduction. A dose-response was demonstrated for both BCX4208 and allopurinol, and the combination of BCX4208 and allopurinol was shown to be superior to either drug alone in sUA reduction. In five of these nine combination groups, 80 percent or more of the patients achieved a sUA concentration of less than 6 mg/dL. Combinations of lower doses of BCX4208 with allopurinol showed synergistic effects in sUA reduction. The doses of BCX4208 alone and in combination with allopurinol evaluated in the study were generally safe and well-tolerated.
• In the pivotal Phase 2 study of 200 mg once-daily forodesine in the treatment of CTCL, eleven percent of late-stage patients (Stage IIB to IVA) achieved a partial cutaneous response. An interim analysis of the ongoing exploratory Phase 2 study evaluating 200 mg of forodesine twice-daily in 25 patients with CLL showed that three patients demonstrated a confirmed partial response to forodesine. Final results from this study are expected later in 2010, and the Company plans to present these results at an upcoming medical meeting. BioCryst is exploring the interest level of potential partners as a possible path forward for the future development of forodesine in the U.S.

• BioCryst has submitted a contract modification to HHS/Biomedical Advanced Research and Development Authority (BARDA), to include an additional efficacy study and Government funding to complete the Phase 3 development of i.v. peramivir. Start-up activities for the upcoming flu season have been approved by HHS/BARDA under the existing contract and are underway.
• BioCryst has recently presented new clinical safety and influenza B virologic data for i.v. peramivir at two medical meetings, ICAAC and IDSA.
• BioCryst is finalizing plans for a 12 week, randomized, controlled study of BCX4208 as add-on therapy in gout patients who have failed to adequately respond to allopurinol. The 200+ subject study is expected to begin enrollment in early 2011. The Company also plans to initiate a long-term safety study in 2011.
• During BioCryst's Investor Day event in September, the Company announced plans to conduct additional pre-clinical development activities to support the advancement of BCX4161 as a potential novel plasma kallikrein inhibitor for the treatment of hereditary angioedema.

Source: http://www.biocryst.com/