BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced financial results for the fourth quarter and full year ended December 31, 2012.
"Our team is focused on achieving near-term milestones to rebuild shareholder value. Our primary goal is to advance our potentially ground-breaking oral kallikrein inhibitors for hereditary angioedema. Phase 1 clinical trials for the lead compound, BCX4161, are scheduled to begin in the next few months and we are finalizing lead optimization for our second generation compound," said Jon P. Stonehouse, President & Chief Executive Officer. "Furthermore, we are advancing BCX4430, a broad spectrum antiviral that could fill an important gap in the U.S. Government's medical countermeasure stockpile. Based on BCX4430's efficacy in treating various hemorrhagic fever viruses in animals, this compound could satisfy this important unmet need."
Fourth Quarter Financial Results
For the three months ended December 31, 2012, revenues decreased to $4.1 million, from $5.2 million in the fourth quarter of 2011. This decrease resulted primarily from a reduction in collaboration revenue from a contract with the Biomedical Advanced Research and Development Authority, within the U.S. Department of Health and Human Services (BARDA/HHS), for the development of peramivir.
Research and development (R&D) expenses for the fourth quarter of 2012 decreased to $11.1 million from $14.2 million in the fourth quarter of 2011. In 2012, lower development costs associated with the peramivir and ulodesine programs were partially offset by higher development costs associated with the preclinical BCX5191 and BCX4161 programs.
General and administrative (G&A) expenses for the fourth quarter of 2012 decreased to $1.9 million compared to $2.1 million in the fourth quarter of 2011, largely due to reductions in administrative expenses during 2012 associated with the continued realization of cost containment measures and the Company's restructuring of its operations. Fourth quarter 2012 expenses included a $1.8 million charge related to the corporate restructuring announced in December 2012.
Interest expense related to non-recourse notes was $1.2 million in the fourth quarter of 2012 and 2011. In addition, a $0.8 million mark-to-market gain on the Company's foreign currency hedge was recognized in the fourth quarter of 2012, compared to a $1.1 million mark-to-market loss in the fourth quarter of 2011. These hedge gains and losses resulted from changes in the U.S. dollar/Japanese yen exchange rate related to a foreign currency hedge arrangement entered into in conjunction with the RAPIACTA® royalty monetization transaction.
The net loss for the fourth quarter 2012 was $11.1 million, or $0.22 per share, compared to a net loss of $13.2 million, or $0.29 per share, for the fourth quarter 2011.
2012 Financial Results
For the year ended December 31, 2012, total revenues increased to $26.3 million from $19.6 million in 2011. The increase was due to the recognition of $7.8 million of previously deferred forodesine-related revenue in the first quarter 2012, as well as the recognition of $3.3 million royalty revenue from Shionogi & Co., Ltd. related to RAPIACTA® sales in the second half of 2012. The aggregate revenue increase was partially offset by a decrease in peramivir collaboration revenue from BARDA/HHS due to a reduction of peramivir development activity in 2012, as compared to 2011.
R&D expenses decreased to $51.5 million for 2012 from $57.2 million in 2011. A decrease in 2012 development costs related to the ulodesine and peramivir programs were partially offset by higher BCX5191 and BCX4161 development costs, as compared to 2011. Expenses for 2012 included the recognition of $1.9 million of non-cash, previously deferred expenses associated with the transfer of forodesine development activity to Mundipharma International Holdings Ltd. in the first quarter of 2012.
G&A expenses decreased significantly to $6.8 million in 2012 from $12.0 million in 2011, due to realization of cost containment measures, and the relocation of BioCryst's corporate headquarters in 2011. Total operating expenses decreased to $60.2 million in 2012 from $69.2 million in 2011.
The net loss for 2012 decreased to $39.1 million, or $0.79 per share, compared to a net loss of $56.9 million, or $1.26 per share for 2011.
Cash and investments totaled $37.1 million at December 31, 2012, a $20.6 million decrease from the $57.7 million balance at December 31, 2011. Net operating cash use for the fourth quarter of 2012 was $7.1 million and excludes $0.3 million of collateral received under the Company's foreign currency hedge arrangement. Net operating cash use for 2012 was $36.8 million, which was at the low end of BioCryst's net operating cash use guidance of $37 to $43 million, and total cash use was $38.5 million.
Clinical Development Update & Outlook