Feb 4 2010
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced financial results for the fourth quarter and year ended December 31, 2009.
"Over the past year, BioCryst has made great strides towards the goal of building an enduring and successful biopharmaceutical company," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst Pharmaceuticals. "Peramivir has delivered the first marketing authorization and first product sales revenue for a BioCryst discovered drug."
Mr. Stonehouse continued, "We ended 2009 with a strong balance sheet and greater financial flexibility to advance our programs. In 2010, we look forward to seeing clinical data from a variety of our ongoing studies."
Fourth Quarter Financial Results
For the three months ended December 31, 2009, total revenues were $54.9 million compared to $34.2 million for the three months ended December 31, 2008. This increase was driven by $22.9 million in product sales, primarily the $22.5 million order of 10,000 courses of intravenous (i.v.) peramivir from the Department of Health and Human Services (HHS), as well as the $7.0 million milestone payment from the Company's partner, Shionogi & Co., Ltd., related to its filing of a New Drug Application (NDA) to seek regulatory approval for i.v. peramivir in Japan. During the current quarter, revenue from the contract with HHS for the development of peramivir for patients hospitalized with influenza also increased as two global Phase 3 studies were initiated. These increases in revenues were offset by lower amortization of deferred revenue from collaborations. Specifically, $26.5 million of previously deferred revenue related to the termination of the Company's collaboration with Roche was recognized during the fourth quarter of 2008.
Research and development (R&D) expenses increased to $31.6 million for the fourth quarter of 2009 from $22.1 million in the prior year period. The higher R&D expenses resulted from an increase in clinical development costs associated with our peramivir program and an increase in manufacturing costs as the Company completed the production of approximately 130,000 courses of peramivir. In addition, clinical development costs increased during the current quarter as the Company initiated a Phase 2 study of BCX4208 for the treatment of gout. These increases were offset by reductions in clinical development and manufacturing costs for the forodesine program. During the fourth quarter 2008, the Company recognized $8.2 million of previously deferred expense from the termination of its collaboration with Roche.
General and administrative (G&A) expenses increased to $3.6 million for the fourth quarter of 2009 from $2.4 million for the fourth quarter of 2008, primarily due to increases in legal and consulting fees.
Interest income for the three months ended December 31, 2009 was $0.1 million as compared to $0.3 million for the same period of last year. The decrease was driven by a lower average cash and securities balance, as well as significantly lower yield earned on interest-bearing assets.
Net income for the fourth quarter of 2009 was $15.2 million, or $0.37 per basic share and $0.35 per diluted share, compared to net income of $10.1 million, or $0.26 per share for the fourth quarter of 2008.
As of December 31, 2009, the Company held cash, cash equivalents and investments of $94.3 million, an increase of $55.8 million during the fourth quarter of 2009. The higher cash position was driven primarily by receipt of $45.7 million in net proceeds from the public offering of BioCryst common stock, as well as $22.5 million of peramivir product sales to HHS.
The sale of 5,000,000 shares of BioCryst common stock was priced at $9.75 per share and the offering closed as planned on November 25, 2009.
Full Year 2009 Financial Results
Total revenues increased to $74.6 million for the year ended December 31, 2009 as compared to $56.6 million for the year ended December 31, 2008. This change was driven by product sales to HHS and the milestone payment from Shionogi during the fourth quarter 2009, as well as higher revenues related to the contract with HHS for the development of peramivir. These increases were offset by lower amortization of deferred revenue from our collaboration arrangements. 2008 revenue included the deferred revenue related to the termination of its collaboration with Roche mentioned above.
R&D expenses decreased to $72.3 million for 2009 from $73.3 million for the prior year due to reductions in clinical development and manufacturing costs related to the forodesine program, lower costs related to toxicology studies and pre-clinical compounds, as well as a decrease in general operating and personnel related costs. These decreases were offset by higher clinical development costs associated with peramivir and BCX4208, as well as an increase in manufacturing and consulting fees for the peramivir program.
G&A expenses increased to $11.5 million for 2009 from $10.4 million for 2008. This increase was primarily due to higher legal and consulting fees.
Interest income for 2009 was $0.3 million as compared to $2.4 million for the prior year, due to a lower average cash and securities balance as well as significantly lower yield earned on interest-bearing assets.
The net loss for the year ended December 31, 2009 was $13.5 million, or $0.35 per share, compared to a net loss of $24.7 million, or $0.65 per share for the year ended December 31, 2008.
For 2010, BioCryst expects cash use to be between $25 and $30 million. Cash use will vary depending on clinical outcomes.
Recent Program Highlights
Peramivir Program
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On January 27, BioCryst's partner Shionogi announced the commercial launch of RAPIACTA (i.v. peramivir) to treat patients with influenza in Japan. This launch occurred less than two weeks following marketing and manufacturing approval for RAPIACTA in Japan.
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In November 2009, BioCryst received an initial order for 10,000 courses of i.v peramivir (600 mg once-daily for five days) with a value of $22.5 million under a newly issued contract with HHS. Under the contract, HHS may place additional orders, up to a total of 40,000 courses of i.v. peramivir.
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BioCryst's partner Green Cross Corporation filed for approval of peramivir in South Korea. Countries that have approved, ordered or authorized use of peramivir during this flu season include the U.S., Japan, Israel, Mexico, Australia and South Korea.
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In January, BioCryst announced two new partners to exclusively represent peramivir for stockpiling opportunities in their territories: Merck Serono for Europe, Russia, Canada and Singapore; and Hikma Pharmaceuticals PLC for the Middle East and North Africa (MENA) region, excluding Israel. Together, BioCryst and its seven regional partners for peramivir cover most of the world's pharmaceutical markets.
Forodesine Program
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In January 2010, the pivotal Phase 2 study for forodesine in the treatment of cutaneous T-cell lymphoma (CTCL) achieved its protocol-specified objective of enrolling 100 late-stage patients (Stage IIB to IVA). The Company expects to report data from the study in the second half of 2010.
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The Phase 2 single-arm, open-label study evaluating 200 mg of forodesine twice-daily in patients with chronic lymphocytic leukemia (CLL) is beyond half way to its enrollment target of 26 patients and is ongoing.
BCX4208 Program
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During the fourth quarter 2009, BioCryst began enrolling a randomized, double-blind, placebo-controlled Phase 2 study to evaluate the efficacy and safety of BCX4208 in subjects with gout. The study's primary objective is to determine the effect of different doses of orally administered BCX4208 on serum uric acid levels in patients with gout. Results from the first part of this study are expected in the second quarter of 2010.
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BioCryst is evaluating alternatives for an additional blinded study to evaluate the efficacy and safety of BCX4208 as an add-on treatment with another urate-lowering treatment for gout that has a different mechanism of action.
Genetics identified as key factor in gout development