BioCryst Pharmaceuticals, Inc. (BCRX)
Q4 2009 Earnings Call
February 4, 2010 11:00 am ET
Robert Bennett - IR
Jon Stonehouse - CEO
Bill Sheridan - CMO
Stuart Grant- CFO
Charles Duncan - JMP Securities
Bret Holley - Oppenheimer & Co
Ren Benjamin - Rodman
Steve Byrne - Banc of America/Merrill Lynch
Steve Brozak - WBB Securities, LLC
Michael Smith - Leerink Swann
Charles Duncan - JMP Securities
Don Bennett - Los Angeles City School
Michael Murphy - New World Investor
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Thank you and good morning. Welcome to BioCryst fourth quarter and full-year 2009 financial results conference call and corporate update. Today's press release and accompanying slides 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 your 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, 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 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.
This morning Jon Stonehouse will provide an overview of highlights and progress during 2009 and anticipated news flow and events during 2010. And Bill Sheridan will provide a clinical program update and Stuart Grant will conclude with the financial results and a review of our balance sheet and cash use outlook, before we open the call up for Q&A.
With that, I'll turn the call over to Jon.
Thanks, Rob. Good morning and thanks for joining us today. Over the last year, BioCryst has made substantial progress towards the goal of becoming an enduring successful biopharmaceutical company, where success is measured by moving our drugs to the market. We have transformed BioCryst from a discovery focused company to one with its first, full market approval, product sales revenue and an advanced pipeline that includes an increasing number of late stage clinical development programs.
Here is how we're building the company. Our primary focus is on peramivir approval to treat hospitalized flu patients in the U.S., as a key mid-term value driver. We have broadened our development portfolio by initiating a program for gout, an important and growing disease, where BCX4208 may address an unmet treatment need. The secondary stock offering and stockpiling strengthened our balance sheet and provided a long runway to support investment in your programs. And finally, our peramivir inventory and established partnerships have positioned us well to support any new stockpiling opportunities.
In January, we were excited to report the first-ever approval of a BioCryst discovered drug, our partner Shionogi has already begun the commercial launch of peramivir under the trade name RAPIACTA in Japan for the treatment of influenza. This approval came in advance of our expectations from Phase III data in mid-July to filing in late October to approval and price listing in January. Shionogi and the health authorities in Japan both moved very fast.
The pace of this filing and approval underscores once again the need for an intravenous antiviral for influenza. This approval creates a recurring revenue opportunity for BioCryst in the form of double-digit royalties on net sales, as well as potential commercial milestones up to $95 million. Shionogi estimates that over 10 million Japanese citizens annually are treated with influence antivirals. Shionogi has committed to manufacture around 700,000 doses over the first quarter. The Japanese government has also established a goal to increase its antiviral stockpile to cover up to 50% of its population or about 60 million people, creating an additional opportunity for peramivir in Japan.
Other recent highlights include the Green Cross filing for peramivir approval in South Korea in December. A total of six countries have now approved, ordered, or authorized use of peramivir during this flu season, including a $22.5 million order from the U.S. government.
BioCryst was awarded an additional $77.2 million by HHS to fund the Phase III program of IV peramivir. Enrolment is complete for the forodesine pivotal study in CTCL. And last, but certainly not least, a Phase II study of BCX4208 in patients with gout was initiated. This is a large and important market opportunity with approximately 2.5 to 3 million gout patients in the U.S. alone.
Now I'd like to turn it over to our Chief Medical Officer, Bill Sheridan, who will update you regarding our clinical programs.
Thanks, Jon. In late 2009, we initiated two Phase III studies of i.v. peramivir for patients hospitalized with influence. One study compares standard of care of peramivir, the standard of care for placebo, and it's been conducted primarily outside the United States. Enrollment is underway in this study and we are continuing to make progress in activating the required total number of study sites.