BioCryst Pharmaceuticals, Inc. (BCRX)
Q1 2010 Earnings Call
April 28, 2010 11:00 am ET
Robert Bennett - IR
Jon Stonehouse - CEO
Bill Sheridan - CMO
Stuart Grant - CFO
Charles Duncan - JMP Securities
Bret Holley - Oppenheimer
Steve Byrne - Merrill Lynch
Bill Pottery - DFL
Steven Harr - Morgan Stanley
Ren Benjamin - Rodman
Joseph Schwartz - Leerink Swann
Michael Murphy - New World Investor
BioCryst Pharmaceuticals, Inc. Q4 2009 Earnings Call Transcript
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Welcome to today's BioCryst first quarter 2010 conference call. Today's call is being recorded. At this time for opening remarks and introduction, I'll turn the call over to Mr. Robert Bennett. Please go ahead, sir.
Thank you and good morning. Welcome to BioCryst first quarter 2010 financial results conference call and corporate update. Today's press release are available on our website at biocryst.com. At this time, all participants are in a listen-only mode. Later we will open up the call for questions. Instructions for Q&A will be provided at that time.
Joining me today on the call are Jon Stonehouse, our Chief Executive Officer; Bill Sheridan, our Chief Medical Officer; and Stuart Grant, Chief Financial Officer.
Before we begin, I'll read a formal statement regarding risk factors associated with today's call. Today's conference call will contain forward-looking statements, including statements regarding future results, unaudited and forward-looking financial information and the company's performance or achievements. These statements are subject to known and unknown risks and uncertainties, which may cause our actual results, performance or achievements to be materially different from any future results or performance expressed or implied in this presentation.
You should not place undue reliance on the forward-looking statements. For additional information, including important risk factors, please refer to BioCryst's documents filed with the SEC, which can be found on our company website.
Following an overview of Q1 results and developments by Jon Stonehouse and Stuart Grant, Bill Sheridan will then discuss the interim results from the first part of our BCX4208 Phase 2a study in patients with gout. Then we will open up the call for Q&A.
With that, I'll turn the call over to Jon.
Thanks Rob. Good morning and thanks for joining us today. Since our year-end 2009 call on February 4th we continued to execute our plan to build an enduring successful biopharmaceutical company. Our primary focus remains on transforming our pipeline by advancing our late stage development programs and by initiating new clinical programs over the next few years. The positive results announced today from the first part of our BCX4208 gout study represent an important step forward.
In addition our II i.v. peramivir Phase 3 studies in hospitalized patients intended to support US filing are proceeding as plan. Assuming flu infection rates were turned to adverse levels during the upcoming southern and northern hemisphere season the two studies should reach their enrollment target during the first half of 2011.
We are continuing discussions with the FDA and HHS regarding other studies or data analysis that could provide additional evidence of efficacy for the peramivir development program.
In the first quarter we received a final regulatory milestone of $7 million from Shionogi associated with the marketing authorization of peramivir as well as the first royalty payment from Shionogi for their initial sales of RAPIACTA in Japan of $700,000.
The January launch in Japan coincided with the period of very low flu incidence and this royalty for the quarter reflects the low flu activity. What’s important is that RAPIACTA is now on the market in Japan and we have a strong partner that’s well prepared to compete in this important market, when flu picks up again and inevitably it will.
Lastly we are on track to report top line data from our four clinical studies during 2010. These includes two BCX4208 gout studies, the on going monotherapy dose-ranging study and a combination study of BCX4208 and allopurinol as well as II forodesine oncology studies, the Pivotal CTCL and exploratory Phase II CLL study. We look forward to sharing our results later this year.
I would like to turn it over to Stuart to cover our financials.
I will keep my comments regarding the recent quarter results and our cash position brief. From a financial perspective, we are on track to deliver our cash guidance for the year and that will support the clinical program we are outlining for you today.
Key contributors to the quarter, $26.1 million of revenue, it includes $10.7 million under the HHS development contract for peramivir, the $7 million Shionogi in milestone impairment, John mentioned and $6.4 million in collaboration revenue from the sale of peramivir API to Shionogi and Green Cross.
Total revenues in last year's quarter were $4.4 million. R&D expenses were up due to a second consecutive quarter of peramivir Phase III development activity and BCX4208 gout trial cost as well as $6.3 million from the same process of the peramivir API for a partner Venezia.
G&A expenses were higher mainly due to consulting fees related to supply chain and process optimization projects. G&A expenses supporting planned activities are expected to trend down from the Q1 level for net loss of $2.6 million, compared to $9.3 million in the same quarter last year. The use of cash during the first quarter was 4.8 million and our outlook cash use of between $25 million and 30 million for 2010 remains unchanged.
Now, Bill, our Chief Medical Officer will talk about the BCX4208 gout results.