BioCryst Pharmaceuticals, Inc.

Welcome to the Biochrist second quarter 2022 earnings conference call. My name is Vanessa, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. During the question and answer session, with your question, you can enter the queue by pressing zero, then one. I will now turn the call over to your host, Mr. John Bluth at Biochrist.

Thanks very much, Vanessa. Good morning and welcome to Biocris second quarter 2022 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'll 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. The Orla Dale launch continues to be very strong. Revenue is on track to exceed $250 million this year. New patient starts remain consistently strong now for six quarters in a row. The prescriber base is expanding and deepening. The 96-week data we've begun promoting is resonating with our customers, and the switch data shows Orladeo is maintaining disease control while decreasing disease burden. While the vast majority of our revenue is still from the U.S., sales from Europe are starting to grow, and all of this is good news for HAE patients. This is even more exciting when you realize there's so much more opportunity ahead of us. which leads us to refine our guidance for this year to between $255 and $265 million and continue to track toward $1 billion at peak. Why is this important? Having a meaningful product in the market growing quarter after quarter with very long IP creates an amazing base to build on. In this challenging financial environment, having significant and steady revenue growth is rare, and critically important to creating greater value. Our plan is to repeat this Orladeo success with our pipeline molecules for other patients suffering from rare diseases. Few companies can get one successful product to market, but if you're able to do it again and again, you can compound value. Key elements to getting there are having a strategy to bring therapies forward that patients truly want and being disciplined by following the data and insights gathered objectively to make informed business decisions about when to invest and when not to. Orla Deo's success is a great example of this. Wouldn't it have been nice back in the early days of the program if clinical trials and market research pointed to a clear and straight path to success? But that's not how it played out. There were clear challenges and things that went differently than planned along the way. And we were disciplined in objectively following the data, studying the switch market carefully, and quickly leverage those insights to make the investment decisions that ultimately are paying off today with our successful launch. We use this approach in all our capital allocation decisions, including our pipeline. This disciplined approach is especially important in the current environment. We see the complement area and the ability to bring oral drugs to fill large unmet needs for these rare disease patients as a massive opportunity that includes Factor D and extends even more broadly to include other targets. Our immediate decision is to allocate capital in the redeem and renew studies to see if we're able to achieve our goal of finding a safe and effective dose with BCX9930. If the data from the first small group of patients enrolled supports this goal, we'll continue to allocate capital to the 9930 program. If not, we'll stop its development but still pursue factor D inhibitors as we've already invested in next-generation backups and molecules that we hope will be improvements. With the partial clinical hold now removed, preparations to restart enrollment have begun, and Helen will share more with you on what we know now and how we plan to proceed. We have a successful rare disease launch with Orlodeo growing into a global blockbuster. We have an exciting pipeline of compounds, some you know about and some you don't yet. And lastly, we have substantial capital to make thoughtful capital allocation decisions. This is a unique and very good spot to be in in the current environment. And that brings me back to where I started. The tremendous market success of Orladeo. The steady and consistent revenue growth, discipline and objective decision making on capital allocation and alternative financing sources like the additional debt from Ethereum we recently drew down. are the things that give us confidence we can repeat the Orlodeo success with other molecules and create much greater value in the process. Now I'll turn the call over to Charlie to share additional details on another strong quarter of growth of Orlodeo. Charlie?