BioCryst Pharmaceuticals, Inc.

Good morning, ladies and gentlemen, and welcome to the Biochrist first quarter 2020 earnings call. At this time, all the participant lines are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star, then zero on your touchtone telephone. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Mr. John Bluth at Biochrist.

Thanks, Whitney. Good morning and welcome to BioCrisp First Quarter 2020 Corporate Update and Financial Results Conference Call. Today's press release and slides are available on our website. Participating with me today are CEO John Stonehouse, CFO Anthony Doyle, Chief Medical Officer Dr. Bill Sheridan, Chief Business Officer Megan Snizinski, and Chief Commercial Officer Charlie Gayer. Following our remarks, we will answer your questions. Before we begin, please note that today's conference call will contain forward-looking statements, including those statements regarding future results unaudited and forward-looking financial information as well as the company's future performance and 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 these forward-looking statements. For additional information including a detailed discussion of our risk factors, please refer to the company's documents filed with the Securities and Exchange Commission which can be accessed on our website. I'd now like to turn the call over to John Stonehouse.

Thank you, John, and thank you all for joining us this morning. I hope you're all safe and doing well. We are in an extraordinary position at Biochrist. The company is set to receive three approvals within the next 12 months for Baratrolstat. We expect our first global approval in Japan in the second half of the year. We have a December 3rd PDUFA date from the FDA, and in Europe, our MAA was validated in March, and we expect approval about that time next year. Right alongside these approvals, we have a pipeline and a molecule with our oral factor D inhibitor, BCX9930, for complement-mediated diseases, including PNH. We will share exciting data for 9930 and PNH patients with you for the first time today. Let's start with HAE and the value we expect to create with Baird-Charleston. Patients are experiencing significant benefit in our clinical trials. Both physicians and HAE patients are consistently stating strong demand for our oral medicine in our market research. Based on the clinical response and the customer demand, we expect Baratrolstat will generate peak sales of north of $500 million. And we announced yesterday that we have a new composition of matter patent that will extend our patent protection by four years to 2039. Add to that market potential for 9930 in an established market of more than $4 billion for treatment of complement-mediated diseases, and we see a significant opportunity for even greater value creation. We have built a company focused on discovering, developing, and commercializing oral drugs for rare diseases. We continue to advance our oral rare disease pipeline, which also includes BCX9250 for FOP, and additional discovery programs for other rare diseases. Beyond that, we've always believed our legacy antiviral programs play an important role in public health. Galidesivir is a broad spectrum antiviral in a NIAID-funded trial in COVID-19 patients. The experience and relationships we have developed across the U.S. government over the past decade to support our antiviral programs continue to add value. We have contracts totaling $82 million of government funding for Galidesivir, and we've been able to move quickly with Galidesivir into COVID-19 patients. Patient dosing has begun in our clinical trial in Brazil, and we look forward to generating data to determine if Galidesivir could help in this global health emergency. The disruption of the coronavirus pandemic has impacted every company. While the situation is fluid for the most part, BioQuest continues to maintain its progress and timelines. We're fortunate that the clinical trials and data to support our regulatory submissions for Baratrolstat were already completed at the time of the pandemic. As a result, our regulatory reviews are well underway, and our approval timelines and launch preparation activities remain on track. Charlie and Megan have been building the global commercial and medical affairs teams and drug supply to support our upcoming launches. and they'll provide an update. Then Bill will review our new data with 9930. Anthony will provide a financial review and I will wrap up by sharing our progress with Galidesipir. With that, I'll turn the call over to Charlie.