BioCryst Pharmaceuticals,Inc. (BCRX): BioCryst Reports Third Quarter 2007 Fin...

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Thursday, 11/08/2007 12:34:36 PM

Thursday, November 08, 2007 12:34:36 PM

BioCryst Reports Third Quarter 2007 Financial Results and Corporate Update
7:00a ET November 8, 2007 (PR NewsWire)
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced financial results for the third quarter ended September 30, 2007.

Key Operating Results

The Company reported revenues of $20.5 million in the third quarter of 2007, compared to $1.8 million in the third quarter of 2006. The net loss for the quarter ended September 30, 2007 was $11.0 million, or $0.32 per share, compared to a net loss of $15.6 million, or $0.53 per share, for the quarter ended September 30, 2006.

As of September 30, 2007, the Company had cash, cash equivalents and investments of $102.2 million.

Third Quarter 2007 Financial Results

Collaborative and other research and development revenues increased in the third quarter of 2007 to $20.5 million compared to $1.8 million in the same period last year. The increase is primarily due to revenue recognized from the contract with the U.S. Department of Health and Human Services (DHHS) for the development of peramivir and the continuing amortization of deferred revenue from our collaborative agreements.

Research and development ("R&D") expenses were $29.7 million in the third quarter of 2007, compared to $16.7 million in the third quarter of 2006. The increase in R&D expenses is primarily attributable to an increase in clinical trial related expenses, manufacturing costs for our lead drug candidates and costs related to an increase in the personnel supporting the advanced development of our drug candidates.

General and administrative ("G&A") expenses were $2.6 million for third quarter of 2007, compared to $1.6 million for the third quarter of 2006. The increase in G&A expenses is primarily due to an increase in personnel related costs as a result of increased headcount, including an increase in the non- cash share-based compensation expense for the quarter and an increase in professional fees.

Year-to-Date 2007 Financial Results

Collaborative and other research and development revenues increased for the nine months ended September 30, 2007 to $43.1 million compared to $4.1 million in the same period of last year. The year-to-date increase is primarily due to revenue recognized from the contract with DHHS for the development of peramivir and the continuing amortization of deferred revenue from our collaborative agreements.

R&D expenses were $64.9 million for the nine months ended September 30, 2007, compared to $35.9 million for the same period in 2006. The increase in R&D expenses is primarily attributable to an increase in clinical trial related expenses, manufacturing costs for our lead drug candidates and costs related to an increase in the personnel supporting the advanced development of our drug candidates.

G&A expenses were $7.0 million for the nine months ended September 30, 2007, compared to $4.5 million for the same period in 2006. The increase in G&A expenses is primarily due to personnel related costs, including an increase of $1.2 million in the non-cash share-based compensation expense for the period, and an increase in professional fees.

The net loss for the nine months ended September 30, 2007 was $26.8 million, or $0.86 per share, compared to a net loss of $33.6 million, or $1.15 per share for the same period last year.

Recent corporate and financial highlights -- Continued development of intramuscular (i.m.) peramivir clinical trial In September, BioCryst reported preliminary results from a phase II study of the intramuscular formulation of peramivir. The study was designed to determine if this formulation of peramivir could reduce the duration of symptoms in subjects with acute influenza. While the results of the trial indicate that a single dose of peramivir demonstrated a treatment effect over placebo, the improvement was not statistically significant. The Company continues to receive and analyze data from this recently completed trial. In addition, the Company is carrying out additional PK studies to support this analysis. Armed with the further analysis and following discussion with the FDA, the Company is planning to initiate the pivotal program in time to take advantage of the upcoming influenza season. -- Continued development of intravenous (i.v.) peramivir Phase II clinical trial In July, BioCryst initiated a Phase II clinical trial of i.v. peramivir for the treatment of hospitalized subjects with severe influenza. The trial is designed to compare the efficacy and safety of i.v. peramivir to orally administered oseltamivir in subjects who require hospitalization due to acute influenza. BioCryst plans to continue the trial in the northern hemisphere during the 2007/2008 influenza season. -- Initiation of oral forodesine HCl pivotal clinical trial In October, BioCryst enrolled the first patient in a pivotal Phase II clinical trial of oral forodesine HCl in patients with cutaneous T- cell lymphoma (CTCL). The multinational trial is being conducted in accordance with a Special Protocol Assessment (SPA) agreement between the FDA and BioCryst granted earlier this year. -- Initiation of oral BCX-4208 Phase IIa clinical trial In July, BioCryst and Roche initiated the first Phase II clinical trial to evaluate BCX-4208. The study, led by Roche is designed to evaluate the compound in patients with moderate to severe plaque psoriasis. -- Completion of $65.3 million financing In August, BioCryst completed a $65.3 million private placement financing with a group of existing BioCryst stock holders. The offering was composed of approximately 8.3 million shares of BCRX common stock, as well as warrants to purchase an additional approximately 3.2 million shares.

"During the third quarter, we continued to lay the groundwork needed to bring our products to market," said Jon P. Stonehouse, President and CEO of BioCryst. "We made progress with our peramivir, forodesine HCl and BCX-4208 clinical programs and gained added financial flexibility through the completion of a private placement to a group of existing BCRX stock holders."

Conference Call and Webcast

At 10:00 a.m. Eastern Time today, BioCryst will host a conference call and live webcast. BioCryst management will discuss the company's third quarter results and provide an update on the company's programs and business results.

To access the webcast via the internet, log on to http://www.biocryst.com. Please connect to the website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. Alternately, please call 1-800-860-2442 (U.S.) or 1-412-858-4600 (international). Telephone replay will be available. To access the replay, please call 1-877-344-7529 (U.S.) or 1-412-317-0088 (international) and dial the participant passcode 413134#. The webcast will be archived on http://www.biocryst.com

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