Mirum Pharmaceuticals, Inc.

Ladies and gentlemen, welcome to the Miro Pharmaceuticals Report's first quarter 2023 financial results and profile business update. My name is Glenn and I'll be the operator for today's call. If you would like to ask a question during the presentation, you may do so by pressing star 1 on the telephone keypad. I'll now hand you over to your host, Andrew McKibbin, to begin. Andrew, please go ahead.

Thanks, Glenn, and good afternoon, everyone. I'd like to welcome you to Miriam Pharmaceuticals' first quarter 2023 conference call. I'm joined today by our President and CEO, Chris Peets, our Chief Operating Officer, Peter Radovich, and our Head of Research and Development, Pam Bigg. Earlier today, Miriam issued a news release announcing the company's results for the first quarter 2023. Copies of this news release and SEC filings can be found in the Investors section of our website. Full details and updates from the quarter can be found in our news release and 10Q issued today. Before we begin, I'd like to remind you that during the course of this conference call, we will be making certain forward-looking statements about Merrim and our programs based on management's current expectations, including statements regarding Merrim's current and future business plans, development programs, and regulatory expectations, strategies, prospects, market opportunities, and financial forecasts and guidance. Merrim is under no duty to update these statements, and they are subject to numerous risks and uncertainties, and actual results could differ materially from the results anticipated by these statements. Andrew Barber, Investors agreed the risk factors set forth the miriams 10 K, for the year ended December 31 2022 and any subsequent reports filed with the SEC with That said, I like to turn the call over to Chris Chris.

Chris Van Orden, Thank you, Andrew and good afternoon to everyone joining us on the call today. Chris Van Orden, it's been another exceptional quarter for miriam as we continue to advance our leadership position as a high growth rare disease company focused on life changing medicine. Our clinical, regulatory, and business achievements in the first quarter, with total revenue of $31.6 million, are driven by our team's passion and expertise in addressing urgent unmet needs for patients with rare disease. With our five-part strategy to become a global leader in rare disease in place, we're pleased with the progress we've already made in 2023. First, we've continued to build on the successful launch of Live Marley and Allergy Syndrome in the U.S. tracking well on our guidance of 50% year-over-year net product sales growth, driven by new patient starts. Second, our international business is also building well, with a recent launch in Germany and early access programs in France and other international partner markets. We look forward to additional launches around the globe later this year and into 2024. Third, we've accomplished an important step in our strategy to expand the label for Lidmarli, In the first quarter, we announced label expansion to include patients three months and older. In addition, we submitted a supplemental NDA and European equivalent with our positive Livmarli PFIC phase three data. Our team is preparing for the December 13th PDUFA date and is excited about bringing Livmarli as a new treatment option advancing care for PFIC patients. We also anticipate providing top line data from the EMBARQ study in biliary atresia in the second half of this year a third potential indication for Livmarly. And fourth, in advancing into adult indications, we are conducting potentially pivotal studies for Velixibet in primary sclerosing cholangitis and primary biliary cholangitis, and look forward to providing interim updates from these studies in the second half of this year. In the fifth part of our strategy, we continue to evaluate opportunities across rare diseases to leverage Mirim's industry-leading capabilities. We also recently took a significant step towards enabling our strategy with convertible note financing of approximately $316 million aggregate principal amount. This financing enabled the repurchase of the nearly 10% royalty committed to our prior royalty investor and added additional growth capital to the balance sheet. We were excited to see the high level of interest in supporting our strategy in this well oversubscribed transaction. We continue to project that our balance sheet provides three plus years of runway beyond cashflow breakeven. We have started 2023 off with great momentum, and I'm excited about what the Mirim team is poised to achieve this year and beyond as we provide patients with life-changing medicines. And with that, I'll pass the call over to Peter to discuss our commercial business in more detail before Pam gives an R&D update.