Biocryst reports financial results for first quarter 2013

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced financial results for the first quarter ended March 31, 2013.

“In addition, our Phase 1 clinical trial of BCX4161 in healthy subjects is progressing. We expect to complete this clinical trial and report results this summer. If this trial is successful, we plan to initiate a Phase 2 program in hereditary angioedema patients this year.”

"We are pleased that our recent interactions with the FDA have defined a pathway to file a peramivir NDA for regulatory approval in the U.S.," said Jon P. Stonehouse, President & Chief Executive Officer of BioCryst. "In addition, our Phase 1 clinical trial of BCX4161 in healthy subjects is progressing. We expect to complete this clinical trial and report results this summer. If this trial is successful, we plan to initiate a Phase 2 program in hereditary angioedema patients this year."

First Quarter Financial Results

For the three months ended March 31, 2013, revenues decreased to $3.6 million from $12.2 million in last year's quarter. The decrease in 2013 revenue relates primarily to the one-time recognition of $7.8 million of forodesine-related revenue in 2012, and to a lesser extent, a reduction in 2013 revenue associated with decreased intravenous (i.v.) peramivir development activity.

Research and development expenses for the quarter decreased to $7.4 million from $15.5 million in the first quarter 2012, due primarily to lower development expenses associated with the peramivir, ulodesine and BCX5191 programs, as well as $1.9 million of deferred expenses associated with the one-time forodesine revenue recognized in the first quarter 2012.

General and administrative expenses for the quarter decreased to $1.4 million compared to $1.7 million in 2012, due primarily to a December 2012 corporate restructuring that reduced BioCryst's cost structure and operations.

In the first quarter of both 2013 and 2012, interest expense was $1.2 million and related to the Company's non-recourse notes payable. In addition, a mark-to-market gain on our foreign currency hedge of $2.0 million and $38,000 was recognized in the first quarter of 2013 and 2012 respectively, resulting from periodic changes in the U.S. dollar/Japanese yen exchange rate.

The net loss for the first quarter of 2013 was $4.5 million, or $0.09 per share, compared to a net loss of $6.1 million, or $0.13 per share, for the first quarter of 2012.

Cash, cash equivalents and investments totaled $28.9 million at March 31, 2013, compared to $37.1 million at December 31, 2012. Net operating cash use for the first quarter of 2013 was $8.9 million, as compared to $12.0 million for the first quarter of 2012.

Clinical Development Update & Outlook

• In April, BioCryst held a Type C meeting regarding i.v. peramivir with the U.S. Food & Drug Administration (FDA). At the meeting, the FDA confirmed that BioCryst's proposed peramivir New Drug Application (NDA) content supports a reviewable NDA submission for the indication of acute uncomplicated influenza. The Company has scheduled a pre-NDA meeting to reach agreement on a complete NDA submission.
• BioCryst will announce its future plans under the peramivir advanced development contract upon receiving formal guidance from Biomedical Advanced Research and Development Authority (BARDA/HHS) following its recently completed In-Process Review.
• In March, BioCryst initiated a Phase 1 clinical trial with BCX4161 to support its development as a treatment for hereditary angioedema (HAE). The main objectives of the Phase 1 clinical trial are to demonstrate safety, adequate and consistent drug exposure, and pharmacodynamic effects after oral administration. In addition, BioCryst has identified several second generation oral HAE compounds, and plans to select a lead candidate for preclinical development later in 2013.
• BioCryst is continuing its collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) regarding filoviruses, while seeking additional U.S. Government funding for the further development of BCX4430 as a broad spectrum antiviral medical countermeasure.

Financial Outlook for 2013

Based upon current trends and assumptions, as well as the Company's restructured operations, BioCryst expects its 2013 net operating cash use to be in the range of $22 to $26 million, and its 2013 operating expenses to be in the range of $25 to $35 million. This outlook is unchanged from the guidance provided in February 2013.

Conference Call and Webcast

BioCryst's leadership team will host a conference call and webcast on Tuesday, May 7, 2013 at 11:00 a.m. Eastern Time to discuss these financial results and recent corporate developments. To participate in the conference call, please dial 1-877-303-8027 (United States) or 1-760-536-5165 (International). No passcode is needed for the call. The webcast can be accessed by logging onto www.BioCryst.com. Please connect to the website at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be necessary.

Source: http://www.biocryst.com/