For the six months ended June 30, 2010, total revenues increased to $33.7 million compared to $9.1 million for the six months ended June 30, 2009. This $24.6 million increase was driven primarily by a $9.8 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 & Co., Ltd. (Shionogi), and the sale of $6.4 million of peramivir active pharmaceutical ingredient (API) to collaborators Shionogi and Green Cross Corporation during the first quarter 2010.
R&D expenses increased to $39.7 million for the first half of 2010 from $22.5 million in the same period as last year. The $17.2 million increase was primarily due to an increase of $7.4 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, as well as higher development costs associated with the BCX4208 program. In addition, personnel related costs and general operating expenses were modestly higher during the first six months of 2010 as compared to the same period in 2009. These increases in R&D expenses were partially offset by lower development costs associated with the forodesine program.
G&A expenses increased to $7.0 million for the six months ended June 30, 2010 from $4.8 million for the six months ended June 30, 2009, primarily due to increases in consulting fees and personnel related costs.
The net loss for the six months ended June 30, 2010 was $12.8 million, or $0.29 per share, compared to a net loss of $18.0 million, or $0.47 per share for the six months ended June 30, 2009.
As of June 30, 2010, the Company held cash, cash equivalents and securities of $81.2 million, a decrease of $13.1 million as compared to December 31, 2009.
BioCryst expects its 2010 cash use to be within, but at the high end of, its previous guidance range of between $25 and $30 million. This is due in part to lower than expected royalty income as a result of the mild flu activity following approval in Japan. In response, the Company has taken action to reduce costs, while maintaining momentum within its clinical programs. This outlook may change depending on the timing of payments from HHS related to the peramivir program.
Clinical Development Update & Outlook
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) in January, and BioCryst expects to report data from the study in the second half of 2010. The Phase 2 single-arm, open-label study evaluating 200 mg of forodesine twice-daily in patients with chronic lymphocytic leukemia (CLL) has reached its enrollment target of 26 patients and is ongoing. The Company expects to report data from this study in the second half of 2010. Enrollment in the Phase 2 study to evaluate the efficacy and safety of BCX4208 alone and in combination with allopurinol in gout patients is proceeding, and the Company expects to announce top-line results from this study by the end of 2010. The Phase 3 development program of i.v. peramivir is ongoing, with investigator sites enrolling patients in the southern hemisphere. Additional studies to provide further evidence of the efficacy of i.v. peramivir in patients with influenza are under discussion with the U.S. Food & Drug Administration and HHS.SOURCE BioCryst Pharmaceuticals, Inc.