BioCryst Pharmaceuticals, Inc.

Thank you all for standing by and welcome to the Biochrist second quarter 2021 earnings conference call. Please note that all participants will be in listen only mode until the question and answer session of today's conference. To ask a question over the phone by that time, you may press the star key followed by the number one. Please also note that today's call is being recorded. I'll now turn the call over to your host, John Bluth. Sir, you may now begin.

Thanks, Jesse. Good morning, and welcome to Biochrist's second 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 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. As you can see in the numbers we reported today with $50 million of revenue, including $28.5 million of Orla Deo net revenue in the second quarter, the Orla Deo launch continues to go very well. We're now in the ninth month of the launch and have a consistent and growing body of evidence from the marketplace that most patients are benefiting and staying on the drug. They are switching from injectable therapies that control their disease because they're achieving the combination of disease control and reduced burden of therapy on Orladeo. The commercial team has done a fantastic job executing despite extremely challenging circumstances. with COVID limiting our ability for face-to-face interactions with our customers in the first half of the year. As you'll hear in more detail from Charlie, our launch success is a direct result of having a drug with the profile patients want, a great plan centered around patient switches, and execution of that plan by an extremely talented and experienced team. This strong start to the Orladeo launch in the U.S. and approvals and launches starting outside the U.S. to get Orladeo to patients around the world give us confidence we'll achieve sales this year of no less than $100 million and puts us on an excellent trajectory to exceed $500 million in global peak sales. A growing revenue stream from Orladeo enables us to continue to invest in our pipeline and advancing other important oral medicines for patients suffering from rare diseases. The best example of this is the BCX9930 program, where in the first half of the year we moved directly from Phase I into pivotal trials in P&H, which we'll begin enrolling later this year. Like HAE, patients with P&H tell us they want an effective therapy with a low burden of treatment. They tell us that the treatment burden with current therapies can be hours in an infusion center. We believe 9930 has the potential to offer a significant benefit to these patients, and we are thrilled that we are entering pivotal trials in this disease. Bill will share an update and our Phase III plans with you shortly. Our goal is to continue growing OrlaDale while in parallel pursuing approvals and launches of 9930 across P&H, renal complement diseases, and many other complement disorders. Biochrist has discovered and developed what is shaping up to be a very attractive pipeline of oral medicines for patients suffering from rare diseases, and we're now demonstrating our commercial rare disease capabilities as well. I'll turn the call over to Charlie to give you more details on the Orladeo launch.