Mirum Pharmaceuticals, Inc.

Good afternoon. Thank you for attending the Miriam Pharmaceuticals fourth quarter and year-end 2022 financial results and business update. My name is Matt, and I'll be your moderator for today's call. All lines will be muted during the presentation portion of the call for an opportunity for questions and answers at the end. If you would like to ask a question, please press star 1 on your telephone keypad. I would now like to turn the conference over to our host, Andrew McKibbin, Vice President of Investor Relations and Finance. Andrew, please go ahead.

Thanks, Matt, and good afternoon, everyone. I'd like to welcome you to Miriam Pharmaceuticals' fourth quarter and full year 2022 conference call. I'm joined today by our president and CEO, Chris Peets, our chief operating officer, Peter Radovich, our head of R&D, Pam Vig, and our CFO, Ian Clements. Earlier today, Miriam issued a news release announcing the company's results for the fourth quarter and full year 2022. Copies of this news release and SEC filings can be found in the investor section of our website. Full details and updates from the quarter can be found in our news release and 10K issue 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 Miriam and our programs based on management's current expectations, including statements regarding Miriam's business plans, development programs, strategies, prospects, market opportunities, and financial forecasting guidance. Miriam 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. Investors should read the risk factors set forth in Miriam's 10-K for the year ended December 31st, 2022, and any subsequent reports filed with the SEC. With that said, I'd like to turn the call over to Chris. Chris?

Thank you, Andrew, and good afternoon to everyone joining us on the call today. In 2022, Miriam made remarkable progress growing into our leadership position as a high-growth rare disease company focused on commercializing life-changing medicines. And while we are all excited about our Q4 quarter-over-quarter sales growth of 48%, we are just getting started. Our clinical, regulatory, and business achievements during the year, with net product sales for Livmarley of $75 million, provide a strong base from which we will rapidly grow our business. We have put in place a five-part strategy to become a global leader in rare disease. First, build on the successful launch of Live Marley and Allergy Syndrome in the US. Live Marley is the first and only treatment in Allergy Syndrome to provide early improvements with long-term impact. And we are still early in making Live Marley available to the addressable Allergy Syndrome patient population. In the second half of last year, we expanded our field presence and investment in the US and now anticipate 50% growth in US Live Marley sales in 2023. This is driven by the MIRIAM team and the tremendous potential of Live Marley for patients, which was highlighted this year by data showing that in allogel syndrome patients who had an itch-low response with Live Marley, 88% of them remained event-free at six years. Now second, grow Live Marley in markets outside the United States. Following European approval in December, we have already launched in Germany, with France to follow shortly, and further launches around the globe later this year and in 2024. Third part of our strategy, expand the label for Livmarly. At the end of last year, we presented Livmarly PFIC Phase III data. This is the largest study conducted in this devastating disease, covering the widest range of PFIC types. In addition to impressive reductions in serum bile acids and pruritus, we saw placebo-controlled improvements in various markers of liver health namely bilirubin and growth, a first I've seen reported for IVAT clinical studies. We have submitted our SMBA and are excited about bringing this strong data profile to prescribers and patients. On our third potential indication for Livmarly, we have also made good progress in the EMBARQ study in biliary atresia and expect to announce data in the second half of this year. Fourth, apply our expertise in IVAT inhibition to expand into adult cholestatic liver disease. Building on earlier iBAT inhibitor data and primary sclerosing cholangitis and primary biliary cholangitis, we are conducting potentially pivotal studies for Velixibat and these two underserved indications. And finally, the fifth part of our strategy, expand our development pipeline for business development activities. We are evaluating a number of interesting opportunities across rare and orphan diseases to leverage Miriam's industry-leading rare disease capabilities. We entered 2023 with great momentum, and I am excited by what the Mirim team can achieve in the near future, providing patients with life-changing medicines that they've been waiting for. 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. Peter?