BioCryst Pharmaceuticals, Inc.

Fourth Quarter 2020 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's 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 would now like to hand the conference over to your speaker today, Mr. John Bluth with Biochrist. You may begin.

Thanks, Daphne. Good morning, and welcome to Biochrist's fourth quarter 2020 corporate update and financial results conference call. Today's press release is 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 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, 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.

Thanks, John. Good morning to all of you, and thanks for joining us. Meaningful value is created by companies that translate great science into clinical benefit and leading to approvals and successful market launches of new medicines that patients are waiting for. And the most successful biotech companies are able to repeat this process of discovery, development, and commercialization across multiple drugs in multiple disease areas. Building this capability doesn't happen overnight, but when you make this transformation, you see real change and real value. That transformation is happening right now at Biochrist. We know patients with rare diseases are waiting for oral treatments despite having injectable therapy to manage their disease. We've heard that for years in HAE and are hearing the same thing in PNH. We've built an exceptional drug discovery platform to go after challenging targets like calocrine inhibitors, factor D inhibitors, and L2 inhibitors. so that we can take this great science, get drug approvals, and finally to the market to put an end to the patients waiting. The approval of Orlodeo in the U.S. and Japan is evidence of this change. Charlie and Megan will describe what we are doing and what we are hearing from customers in the marketplace. And while it's early days in the U.S. launch, they will share why we believe we're off to a good start. Megan will then share with you the even bigger unmet need in Japan for patients suffering from HAE and how Orlodeo can have a big impact as the first approved treatment for preventing attacks. We believe Orlodeo has the potential to generate north of $500 million in global peak sales. Next up is European approval. We expect that approval in Q2, and Charlie will describe how his team in Europe has been preparing for the launch so we can hit the ground running just like we have in the U.S. We also have an increasing body of evidence that we can repeat the success in complement-mediated diseases with our oral factor de-inhibitor. Last year, we shared proof-of-concept data in four P&H patients treated with BCX9930. Bill will update you on the progress of the study and what to expect when we announce the data from a full set of 16 patients, including both treatment-naive patients and C5 inadequate responders. What makes our Oral Factor D program even more valuable and exciting is we plan to go after many complement-mediated rare diseases. Having one molecule to go after many indications could enable us to have several different approvals for many more patients. And finally, you can see the change in our balance sheet. As you will hear from Anthony, capital from our December financing has transformed our company and allows us to put our head down to successfully launch Orladeo around the world and rapidly advance our pipeline. So this transformation is no longer aspirational. It's happening right now, and we're focused on going fast. because we know patients are waiting. Now I'll turn the call over to Charlie to share early insights into our launch. Charlie?