BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced financial results for the second quarter ended June 30, 2015.
“During the second quarter, we continued to make steady progress in executing our strategy and advancing our programs in order to bring forward an attractive oral prophylactic treatment for HAE and to change the lives of HAE patients,” said Jon P. Stonehouse, President & Chief Executive Officer of BioCryst. “In addition, we were very pleased to close a deal with bioCSL as our commercial partner for our approved influenza treatment RAPIVAB. Not only does this deal put RAPIVAB commercialization in the hands of a flu expert, but it extends our cash runway and allows us to focus on rare diseases.”
Second Quarter Financial Results
For the three months ended June 30, 2015, revenues increased to $25.8 million from $1.5 million in the second quarter of 2014. Revenue in the quarter was primarily due to the partial recognition of the upfront payment to BioCryst resulting from the licensing of RAPIVAB® (peramivir injection), as well as a significant increase in collaboration revenue associated with BCX4430 development as a medical countermeasure for Ebola virus and other filovirus diseases.
Research and development expenses for the quarter increased to $16.5 million from $11.1 million in the second quarter of 2014. The increase in 2015 R&D expenses, as compared to 2014, was the result of increased R&D expenses associated with the Company’s HAE and BCX4430 development programs. The more substantial increase was related to development expenses associated with the HAE portfolio and resulted from higher spending for continued development of avoralstat, formerly known as BCX4161, and expenses for second generation compound development, including BCX7353.
General and administrative expenses for the second quarter 2015 increased to $3.5 million compared to $2.0 million in 2014. The increase was due primarily to deal-related expenses, as well as medical affairs and commercial expenses associated with the approval of RAPIVAB and preparation for commercialization of the Company’s HAE product candidates.
Interest expense related to non-recourse notes payable increased in the second quarter of 2015 to $1.3 million from $1.2 million in the second quarter of 2014. In addition, a mark-to-market loss on our foreign currency hedge of $796,000 was recognized in the second quarter of 2015, compared to a loss of $1.8 million in the second quarter of 2014. These 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. During the second quarter of 2015, we also realized a currency gain of $1.5 millionfrom the exercise of a U.S. Dollar/Japanese yen currency option within our foreign currency hedge.
The net gain for the second quarter of 2015 was $4.9 million, or $0.07 per share, compared to a net loss of $14.6 million, or $0.23 per share, for the second quarter of 2014.
Cash, cash equivalents and investments increased to $132.0 million at June 30, 2015, compared to $114.0 million atDecember 31, 2014. This increase resulted primarily from the RAPIVAB upfront licensing payment received from bioCSL. Net operating cash use for the second quarter of 2015 was $12.0 million, as compared to $6.8 million for the second quarter of 2014. Net operating cash use for the first six months of 2015 was $15.8 million as compared to $11.8 million for the 2014 period. With inclusion of the upfront payment from bioCSL, the Company had cash generation of $21.8 and $17.9 million for the second quarter and six months ended June 30, 2015, respectively.
Year to Date Financial Results
For the six months ended June 30, 2015, total revenues increased to $32.7 million from $4.9 million in the first half of 2014. The increase in 2015 was primarily due to the partial recognition of the upfront payment resulting from the licensing of RAPIVAB by bioCSL and increased collaboration revenue associated with BCX4430 development.
R&D expenses increased to $33.6 million for the first half of 2015 from $20.3 million in the same period of 2014. The increase in 2015 expenses was primarily due to increased spending associated with the Company’s HAE and BCX4430 programs.
G&A expenses increased to $7.6 million for the six months ended June 30, 2015 from $3.6 million for the six months ended June 30, 2014, due primarily to unrestricted grants awarded to the U.S. and international HAE patient advocacy groups, as well as medical affairs and commercial expenses associated with the approval of RAPIVAB and preparation for commercialization of our HAE product candidates.
In the first half of 2015 and 2014, interest expense was $2.6 million and $2.5 million, respectively, and related to the non-recourse notes payable. A mark-to-market loss on our foreign currency hedge of $332,000 was recognized in the first half of 2015, compared to a loss of $3.4 million in the first half of 2014. 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. As noted above, we also realized a currency gain of $1.5 million from the exercise of a U.S. Dollar/Japanese yen currency option during the second quarter of 2015.
The net loss for the six months ended June 30, 2015 decreased to $10.3 million, or $0.14 per share, compared to a net loss of $24.8 million, or $0.40 per share for the same period last year.
Corporate Update & Outlook
- The Phase 1 healthy volunteer study of BCX7353 initiated in May is continuing toward completion. In order to properly characterize the steady state pharmacokinetics of BCX7353, a 14 day treatment cohort will be added to this study. As a consequence, final results of this study are now expected in the fourth quarter. BioCryst anticipates reporting results for safety, tolerability, pharmacokinetics and pharmacodynamics.
- The OPuS-2 (Oral ProphylaxiS-2) clinical trial is proceeding as planned, and BioCryst expects to report results at the end of 2015. OPuS-2 is a 12-week, randomized, three-arm, parallel cohort trial. This study evaluates the efficacy and safety of two doses of avoralstat, 300 mg and 500mg, administered three-times daily compared with placebo. Approximately 100 HAE patients will be enrolled in the U.S. and other select countries.
- Three additional BioCryst discovered novel kallikrein inhibitors have recently been selected to advance into preclinical development. These molecules are approximately two years behind BCX7353.
- In June, BioCryst announced that bioCSL, a global biopharmaceutical company and leader in the treatment of influenza, licensed RAPIVAB and will commercialize RAPIVAB in the U.S. and other territories. Under the terms of the agreement, BioCryst received an upfront payment of $33.7 million from bioCSL, and may receive up to $12.0 million in additional payments related to the successful achievement of certain regulatory milestones. BioCryst will also receive tiered royalties on commercial sales in the U.S. and other territories, as well as royalties on ex-U.S. stockpiling orders. BioCryst retained all rights to pursue U.S. government stockpiling for RAPIVAB.
Financial Outlook for 2015
Based upon development plans and assumptions and our awarded government contracts, BioCryst expects its 2015 net operating cash use to be in the range of $18 to $28 million upon adjusting our previously predicted range for the first six month results, including the $33.7 million upfront payment from bioCSL, and expects its 2015 operating expenses to continue to be in the range of $75 to $95 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. (Original Source)
Shares of BioCryst Pharmaceuticals closed yesterday at $14.27. BCRX has a 1-year high of $16.83 and a 1-year low of $7.85. The stock’s 50-day moving average is $15.29 and its 200-day moving average is $11.65.
On the ratings front, BioCryst has been the subject of a number of recent research reports. In a report issued on June 30, Merrill Lynch analyst Tazeen Ahmad upgraded BCRX to Buy, with a price target of $19, which represents a potential upside of 33.1% from where the stock is currently trading. Separately, on May 11, Oppenheimer’s Akiva Felt maintained a Hold rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Tazeen Ahmad and Akiva Felt have a total average return of 83.5% and 35.6% respectively. Ahmad has a success rate of 66.7% and is ranked #72 out of 3728 analysts, while Felt has a success rate of 62.7% and is ranked #24.
Overall, 2 research analysts have assigned a Hold rating and 3 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $13.50 which is -5.4% under where the stock closed yesterday.
Biocryst Pharmaceuticals Inc is abiotechnology company. The Companydesigns, optimizes and develops novel small molecule drugs that block key enzymes involved in the pathogenesis of diseases.