Mirum Pharmaceuticals, Inc.

Hello and welcome to the Mirum Pharmaceuticals first quarter of 2024 financial results and business update. My name is Terry and I'll be the conference operator today. All lines have been placed on mute to prevent any background noise. There will be an opportunity to ask questions today and you can do this by pressing star followed by one on your telephone keypads. I will now hand the call over to Andrew McKibben, Vice President of Investor Relations to begin. Please go ahead.

Thanks, Terry, and good afternoon, everyone. I'd like to welcome you to Merum Pharmaceuticals' first quarter 2024 conference call. I'm joined today by our CEO, Chris Peets, our President and Chief Operating Officer, Peter Radovich, our Chief Medical Officer, Joanne Kwan, and Eric Bierkult, our Chief Financial Officer. Earlier today, Merum issued a news release announcing the company's results for the first quarter 2024. Copies of this news release and SEC filings can be found in the investor section of our website. 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 expectations. 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. Investors should read the risk factors set forth in Miriam's 10Q for the quarter ended March 31st, 2024, and any subsequent reports filed with the SEC. With that said, I'd like to turn the call over to Chris. Chris?

Thanks, Andrew, and good afternoon to everyone. 2024 is tracking to be another year of significant growth for us, and I'm very pleased to highlight our progress across key strategic objectives to grow the commercial business, expand the indications of our commercial medicines, and advance Velixivet to market. We continue to build value while delivering on our commitment to create and commercialize life-changing medicines for rare disease. First, driving growth across our commercial medicines. Total net product sales this past quarter were $68.9 million, representing a 137% increase from the first quarter of 2023. Livmarli continues its strong performance. Newly diagnosed and prevalent patients continue to come to treatment in both the U.S. and internationally. And we are well positioned to meet our full year revenue guidance of $310 to $320 million, driven by continued demand increases across all medicines, international launches, and contribution from the PFIC approval. Second, we are also making significant progress towards expanding the impact of our potentially life-changing medicines through new approvals and label expansions. In March, we announced the U.S. approval of Livmarli and PFIC, an important milestone for Merim and the PFIC patient community. This approval represents the culmination of years of dedication from patients, researchers, and our team. We are excited to be able to bring Livmarli to this community, particularly those patients with rare genetic types of PFIC. The pivotal data was also just published this week in the Lancet, highlighting the improvements in itch, bile acids, bilirubin, and growth seen with Livmarli treatment. And we're off to a great start with positive reception post-approval. We've also made great progress preparing our upcoming NDA submission for Keen et al. for the treatment of CTX. And third, we are advancing Velixibet and PSC and PBC, which are more common adult cholestatic settings, where we can apply the scientific and regulatory insights from the Livmarli program to address bile acid accumulation in patients suffering from these diseases. This quarter, we will be taking an important step in advancing the program with our interim analyses of the in the VISTA's PSC and Vantage PBC studies, which are scheduled in June. We see both indications of significant opportunities as there are no approved therapies for PSC and no approved therapies to treat cholestatic pruritus in PBC. In summary, we continue to make excellent progress across our core strategic objectives, supported by a strong underlying financial position that will allow us to further execute on upcoming opportunities. And with that, I'll turn the call over to Peter to discuss our commercial business.