BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) Q3 2019 Earnings Conference Call - Final Transcript
Nov 06, 2019 • 08:00 am ET
Ladies and gentlemen, thank you for standing by and welcome to the BioCryst Third Quarter Corporate Update. [Operator Instructions]
I would now like to hand the conference over to your speaker today, Mr. John Bluth at BioCryst. Please go ahead, sir.
Thanks very much, Skylar. Good morning and welcome to our call. Today's press releases and accompanying slides are available on our website. Participating with me today our CEO, Jon Stonehouse; Chief Medical Officer, Dr. Bill Sheridan; CFO, Tom Staab; Chief Business Officer, Megan Sniecinski; and Charlie Gayer and Jinky Rosselli from our commercial leadership team. Following our remarks, we'll answer your questions.
Before we begin, I want to direct your attention to Slide 2, which discusses our use of forward-looking statements and potential risk factors regarding an investment in BioCryst. As detailed on the slide, 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 achievement. 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 Jon Stonehouse.
Jon P. Stonehouse
Thank you, John, and thank you all for joining us this morning. We have important new information to share with you today. Clinical results from the 48-week APeX-S and APeX-2 trials and extensive patient, physician, and payor market research. The new clinical results support the meaningful benefit patients are getting from 7353, and the market research supports a very strong willingness from patients to use it. We remain on track to submit our NDA this quarter, our JNDA and MAA in the first quarter of 2020, and to launch next year in the United States. I will also provide a financial update, and we will be happy to take any financial questions in Q&A. You can find our third quarter financial details in today's earnings press release.
As I mentioned, we have a lot of new information to share with you today that's updated our view of the 7353 market opportunity. Bill will review the clinical results in more detail and the data are clear. Over a full year of taking therapy, patients are doing very well on our one capsule once a day oral treatment and having very few breakthrough attacks. We are also sharing with you today the comprehensive market research we conducted with the profile from the 24-week readout of APeX-2. Our team used industry standard data and methods and has quantified a larger HAE population in the U.S. than previously estimated. We also conducted research to understand the current and future view of the treatment landscape.