On May 05, 2016 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) reported financial results for the first quarter ended March 31, 2016 (Press release, BioCryst Pharmaceuticalsa, MAY 5, 2016, View Source [SID:1234511974]).

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"We are currently working through the start-up activities for the APeX-1 trial of BCX7353 for prevention of angioedema attacks in HAE patients and are targeting the end of the year to report results," said Jon P. Stonehouse, President & Chief Executive Officer. "In addition, we are conducting a Phase 1 clinical pharmacology study in healthy volunteers to determine if we are able to meaningfully increase exposure and get to a twice-daily oral dosage form of avoralstat. We expect to report results from this study this summer."

First Quarter Financial Results
For the three months ended March 31, 2016, revenues decreased to $4.8 million from $6.8 million in the first quarter of 2015. The decrease was primarily due to lower collaborative revenue associated with BCX4430 development under the advanced development contract with the Biomedical Advanced Research and Development Authority (BARDA/HHS) awarded in March 2015. In the first quarter of 2015, the Company recorded $537,000 in RAPIVAB revenue, representing drug sold under the sell-through revenue recognition methodology. No RAPIVAB revenue was received in the first quarter 2016 as RAPIVAB commercialization is now being handled by Seqirus UK Limited (Seqirus).

Research and Development (R&D) expenses for the first quarter of 2016 increased to $20.6 million from $17.1 million in the first quarter of 2015. The R&D expense increase in 2016 resulted primarily from higher development costs associated with the Company’s hereditary angioedema (HAE) programs, as well as ongoing post approval clinical trials of RAPIVAB in both pediatric and elderly/high risk influenza patient populations.

General and administrative (G&A) expenses for the first quarter of 2016 decreased to $3.2 million compared to $4 .1 million for the first quarter of 2015. G&A expenses decreased in 2016 due to a significant reduction in unrestricted grants, as well as the elimination of marketing and commercial consulting expense in 2016, as RAPIVAB is now being commercialized by Seqirus.

Interest expense, which is primarily related to non-recourse notes, was $1.5 million in the first quarter of 2016 and $1.3 million in the first quarter of 2015. Also, a $2.8 million mark-to-market loss on the Company’s foreign currency hedge was recognized in the first quarter of 2016, as compared to a $464,000 mark-to-market gain in the first quarter of 2015. The change in the dollar/yen exchange rate between the quarters resulted in a $3.2 million increase to the Company’s net loss for the first quarter of 2016 as compared to 2015. These gains and losses result from periodic changes in the U.S. dollar/Japanese yen exchange rate and the related mark-to-market valuation of our underlying hedge arrangement.

The net loss for the first quarter of 2016 was $22.8 million, or $0.31 per share, compared to a net loss of $15.2 million, or $0.21 per share, for the first quarter 2015.

Cash, cash equivalents and investments totaled $78.9 million at March 31, 2016. Net operating cash use for the first quarter of 2016 was $22.4 million, as compared to $3.8 million for the first quarter of 2015. The first quarter of 2016 is expected to be the largest cash consumption quarter of the four quarters in 2016, and BioCryst expects to remain within previously issued cash use guidance.

Clinical Development Update & Outlook
BioCryst expects to report results of the APeX-1 clinical trial of the once-daily, second generation HAE compound, BCX7353, for prevention of angioedema attacks in HAE patients by year end.

A Phase 1 clinical pharmacology trial testing multiple avoralstat formulations is ongoing in healthy subjects with the aim to develop a twice-daily dosage for HAE patients. Pharmacokinetic results are expected this summer.

BioCryst has completed the Phase 1 clinical trial of single and multiple ascending doses of its broad spectrum antiviral BCX4430 administered by intramuscular (i.m.) injection in healthy volunteers. BCX4430 by i.m. injection was generally safe and well tolerated through doses up to 10mg/kg daily for seven days, the maximum dose planned in the trial.

Nonclinical experiments are continuing with BCX4430 in a model of Zika virus infection in interferon-receptor-deficient mice. Studies conducted to date have shown improved survival with dosing delayed up to 7 days after virus challenge, reduction in viral titer in the blood, and development of protective immunity in surviving animals. This research has been conducted in collaboration with Utah State University and NIAID.

In January, BioCryst submitted a New Drug Submission (NDS) for RAPIVAB in Canada, seeking approval for the treatment of acute uncomplicated influenza in adult patients.

Financial Outlook for 2016
Based upon development plans and our awarded government contracts, BioCryst expects its 2016 net operating cash use to be in the range of $55 to $75 million, and its 2016 operating expenses to be in the range of $78 to $98 million. Our operating expense range excludes equity-based compensation expense due to the difficulty in reliably projecting this expense, as it is impacted by the volatility and price of the Company’s stock, as well as by the vesting of the Company’s outstanding performance-based stock options.