BioCryst Pharmaceuticals, Inc.

Good day, and thank you for standing by. Welcome to the Biochrist Pharmaceuticals first quarter 2022 earnings conference 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 one on your telephone. Please be advised that today's conference is being recorded. If you require assistance during the conference, please press star zero. I would now like to hand the conference over to your speaker today. John Blue, Head of Investor Relations at Biochrist.

Thanks, Daniel. Good morning, and welcome to Biochrist's first 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 Guyer, 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 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. We did 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. With nearly $50 million in net revenue in the first quarter of this year, Orla Deo quarterly sales continue to provide us with real-world evidence and confidence quarter after quarter, that we remain on track for no less than $250 million in net revenue this year and a billion dollars in global peak sales. What's particularly important this quarter, as we face the expected headwinds from some payers requiring reauthorization, higher copay deductibles, and the impact of the Medicare donut hole, is that our team still tapped into strong patient and physician demand for Orladeo and produced quarter-over-quarter revenue growth. Orla Dale plays a critical role to our strategy, and the growing revenue stream is creating value by providing evidence our company can discover, develop, and commercialize successful products and by strengthening our financial position. There's plenty of opportunity to capture, too. Charlie will go into more detail on this and talk about the things we're doing to get this important medicine to every HAE patient who wants to try it around the world. And why would they if they had a chance to be controlled on one capsule once a day? So for the remainder of the year, each quarter we expect that there will be steady revenue growth over the previous quarter, culminating with an annual revenue of no less than $250 million. That's more than a doubling of the first year sales and a quarter of the way to our $1 billion peak sales expectation in just the first two years of launch. Based on what we see so far this year and the trajectory we're on, we remain very confident we can achieve these targets. Our pipeline is another important part to our strategy. Our team has made significant progress in the investigation of the serum creatinine increases in patients in our BCX9930 clinical trials since we first identified this a month ago. While the investigation is not complete, we believe dose is the most likely cause of these elevations, and we'll work with regulators to see if there's a path forward to restarting clinical trials. Bill will share more details on this topic. Regardless of the outcome, patient safety is paramount to us in finding a safe and effective factor D inhibitor remains something we are very committed to because we know many patients suffering from complement-mediated rare diseases are waiting. Whether it's 9930 or one of our backups or both, our goal remains to bring a highly competitive oral factor D inhibitor to patients. We will follow the data and make thoughtful decisions on what to invest in and what not to invest in based on how it helps us reach this goal. Time to market, how the competitive landscape changes, and our product profile will also be important factors in our capital allocation decisions. So when you step back and you look at our company in its entirety, you'll see it's a company with a growing revenue stream coming from a product and a team that's showing they can execute and successfully launch a drug that we believe will grow to a billion dollars at peak. We have a pipeline to create even greater value with the goal of bringing more and more products to the market to patients suffering from rare diseases. And we have a discovery platform that has and will continue to discover innovative molecules to fill our pipeline even further. And finally, we have a solid balance sheet to allocate capital to those things we believe create even greater value. When you see all of that, you see meaningful value creation today, and even greater value creation for the future. I'll now turn the call over to Charlie to talk about Orladeo.