BioCryst Pharmaceuticals, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Biochrist third quarter 2021 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 keypad. 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 Booth at Biochrist. Sir, please go ahead.

Thanks, Lorenz. Good morning, and welcome to Biochrist's third quarter 2021 corporate update and financial results conference call. Today's press release and accompanying slides are available on our website. Participating with me today are CEO John Stonehouse, CFO Anthony Doyle, Chief Commercial Officer Charlie Geyer, Chief Medical Officer Dr. Bill Sheridan, and Chief R&D Officer Dr. Helen Thackeray. Following our remarks, we will answer your questions. Before we begin, please note that today's conference call will contain certain forward-looking statements, including those 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.

Thanks, John. Three-quarters of the way into 2021, and this has been an amazing year of execution for our company. The successful launch of Orladeo and the rapid advancement of our pipeline are the evidence. Orladeo is our first oral drug to get to the market, and by all measures, including that we did it in a pandemic, we significantly exceeded everyone's expectations prior to launch. We now have a good line of sight to the trajectory of sales and have guided that for the full year we will achieve between $115 and $120 million in net revenue. What's even more exciting is we're just getting started. Charlie will share more color on the launch and what opportunities for continued growth lie ahead. The bottom line is patients with HAE want a once-daily oral medicine to prevent their attacks. The strongest evidence of that is they are switching from injectable therapy even when they're controlled and satisfied with these treatment options. Why? Because they want more. They now see an option to control their disease and the ability to reduce the burden of therapy. Our market research told us this two and a half years ago. We're seeing it play out exactly the same way in the marketplace, and Charlie will share recent surveys that show those attitudes will increase in the future. As we continue the consistent, steady growth of the launch in the U.S. and continue to gain approvals and launch in other countries around the world, our confidence that we will substantially exceed our global peak sales target of $500 million grows stronger every quarter. Orladeo is showing that oral drugs can have a huge impact on the lives of patients with rare disease. But what if we could repeat this over and over again in many different rare disease settings? That's our strategy, and we have a world-class discovery platform that differentiates us through its unique capability to develop potent, specific, and orally bioavailable compounds against very difficult biologic targets. Orlodeo is the first to make it to market from our discovery engine, and our oral factor D inhibitor, BCX9930, is next. Going after factor D as a target allows us not only to bring another oral drug to patients suffering from a rare disease, but there are multiple diseases to treat with an oral factor D inhibitor, as the alternative pathway plays a key role in many complement-mediated diseases. After demonstrating proof-of-concept in PNH patients late last year with 9930, we are now in pivotal studies in PNH and a proof-of-concept study in three nephritis indications. Our pipeline is full and following quickly behind Orladea. There are many more rare diseases to pursue and many patients waiting for any drug, let alone an oral drug, to treat their disease. 2021 continues to be an extraordinary year for Biochrist, and the good news is we're just getting started. Now I'll turn the call over to Charlie for more details on the Orladea launch.