BioCryst Pharmaceuticals, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the BioCrisp second quarter 2020 earnings call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I will now like to hand the conference over to your speaker today, Mr. John Bluth of Biochrist. Thank you. Please go ahead, sir.

Thank you, Tamiya. Good morning and welcome to Biochrist's second 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 Stasinski, and Chief Commercial Officer Charlie Geyer. 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 on audited 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 thanks to everyone for joining us this morning. BioChrist is going through a major transformation, and it's happening now. This transformation is from a company primarily focused on R&D to one that's about to launch its first major product this year, start generating real revenue next year, and ultimately leading to global peak sales potential of greater than a half a billion dollars with this first product. HAE patients have been waiting for an oral drug to prevent their attacks and we are excited their wait is nearly over. The transformation continues with a pipeline and a molecule. Our oral factor D inhibitor program led by BCX9930 will fill up our pipeline because of its broad application to complement mediated diseases and many different indications. We have proof of concept in hand for P&H and Bill and his team are driving forward with a plan next year that will run multiple studies in different indications in parallel. And lastly, this transformation is from a company with one key data readout a year to a company with a steady drumbeat of milestones across multiple programs, indications and geographies. Regulatory timelines for Orlodeo are on track, and we expect two approvals this year in the U.S. and Japan, the European approval early next year, and starting with Q1, we will be reporting sales for Orlodeo each quarter beginning next year. On the clinical trial front, we expect data in treatment-naive patients at higher doses with 9930 in the third quarter, and more data by year-end in poor responders. In addition, we expect data from Part 1 of our COVID-19 trial with Galidesivir in Brazil by the end of this quarter. And finally, we expect more clinical progress with 9930 and Galidesivir over the course of next year. We have never been in this spot with so many ways to deliver value to patients and to shareholders. We are laser-focused on the Orladeo approvals and launches and accelerating the Oral Factor De-Inhibitor program. Thanks, John. Thanks, John.