BioCryst Pharmaceuticals, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Biochrist third quarter 2020 earnings call. At this time, all participants are in a listen-only mode. After the speaker 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 any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, John Bluth at Biochrist. Thank you, and please go ahead.

Thanks, Samantha. Good morning, and welcome to BioCrisp Third 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'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. Good morning, and thank you all for joining us. We are 28 days from our PDUFA day with Orla Deo, and we are ready to launch. Charlie and Megan will review the details around our readiness, but suffice it to say, we've been getting ready for this day for many years, and it's so exciting to be less than a month away from bringing our oral once-daily medicine to HAE patients who've been waiting. In addition, our partner in Japan, Tori Pharmaceuticals, is ready to launch. Late last week, we were informed of a recommendation for approval by a PMDA review committee, and we expect an approval decision by the Japanese Ministry of Health in December. While the market is much different from the U.S., This is also very exciting as Orladeo will be the first prophylactic treatment approved for HAE patients in Japan. In Europe, we were excited to announce last week that the MHRA has granted us a positive scientific opinion under their Early Access to Medicine Scheme in the UK. This allows HAE patients and physicians in the UK to gain experience with Orladeo prior to approval. We expect European approval early next year, and launch preparations by our team in Europe are well underway. Our plan is to make Orladeo available to patients around the world. To that end, we've started planning for the next wave of countries to gain approval and bring this oral once-a-day medicine to patients. Our company is transforming. Having a product that we believe can generate over $500 million in global peak sales about to enter the market and a pipeline right behind it with our oral factor D inhibitor for multiple complement-mediated diseases enables us to create sustainable value for years to come. We have many major milestones in the coming months, but perhaps the most important is the U.S. approval of Orladeo. To share more details on how we are prepared for a successful launch, I'll now turn the call over to Charlie and Megan.