Mirum Pharmaceuticals, Inc.

Good afternoon, and welcome to Merham Pharmaceuticals' fourth quarter and full year 2025 conference call. My name is Elliot, and I'll be your operator today. All lines are currently in listen only mode, and there will be an opportunity for Q&A after management's prepared remarks. I'd now like to hand the conference over to Andrew McKibben, SVP of Strategic Finance and Investor Relations. Please go ahead.

Thank you, Elliot, and good afternoon, everyone. I'd like to welcome you to Merim Pharmaceuticals' fourth quarter and full year 2025 conference call. I'm joined today by our Chief Executive Officer, Chris Peetz, our Chief Medical Officer, Joanne Klon, and Eric Bierkolt, our Chief Financial Officer. Peter Radovich, our President and Chief Operating Officer, is unable to join us today as he's attending an international commercial event. Earlier this afternoon, Merim issued a press release reporting our fourth quarter and full year 2025 financial results. Copies of the press release and our SEC filings are available in the Investors section of our website. Before we start, I'd like to remind you that during the course of this conference call, we will be making certain forward-looking statements based on management's current expectations, including statements regarding Merrim's programs and market opportunities for its approved medicines and product candidates and financial guidance. These statements represent our judgment and knowledge of events as of today and inherently involve risks and uncertainties that may cause actual results to differ materially from the results discussed. We are under no duty to update these statements. Please refer to the risk factors in our latest Form 10-K and the subsequent SEC filings for more information about these risks and uncertainties. With that said, I'd like to turn the call over to Chris. Chris?

Thanks, Andrew, and good afternoon, everyone. 2025 was a year of disciplined execution and growth for Miriam, positioning us for a pivotal 2026. On today's call, we'll recap some of the headlines we announced in January and open the call for questions. In 2025, we delivered $521 million in net product sales, exceeding the upper end of our guidance range. This was made up of Litmarli net product sales of $245 million in the U.S., $115 million internationally, with our bile acid medicines also contributing $161 million. The strong finish was driven in particular by our continued leadership in Allergy Syndrome, accelerating PFIC uptake, and growing demand in our international markets. Building on this performance, we are entering 2026 with confidence and expect to deliver net product sales of $630 to $650 million for the year. Beyond commercial performance, we advanced our pipeline through important clinical and regulatory milestones, including the approval of Citexly for CTX and a tablet formulation of Ligmarly and enrollment completion of the VISTA study of Elixabat and PSC. We also meaningfully expanded our pipeline with the addition of the Phase 3 Brolovitac Program for Chronic Hepatitis Delta Virus, a serious, rare disease with limited treatment options. This addition to the portfolio is an excellent fit with our team and the upcoming potential Zalixibat launch, creating substantial operating leverage. Since the closing of the transaction earlier this year, integration has progressed smoothly, and we welcome a team that shares our focus on disciplined execution and delivering high-impact medicines for patients with rare disease. With the addition of Brilovatug, we now have four potentially registrational clinical readouts expected over the next 18 months in areas of significant unmet need. Beginning in the second quarter, we expect to report top-line data from the Velizabat VISTA study and PFC, as well as interim results from the Azure One study of Brilovatug and hepatitis delta. The broader Azure phase three program continues to enroll well, and we expect full top-line results from both Azure 1 and Azure 4 Phase 3 trials in the second half of the year. We're also seeing continued momentum across our other Livmarley and Velixibat programs. Enrollment in the Phase 3 EXPAND study and additional rare cholestatic conditions, as well as the Vantage study in PDC, continues to exceed expectations. And we expect to report top-line results from EXPAND in the fourth quarter of this year and from Vantage in the first half of next. And finally, the Bloom Phase II study of MRM3379 and Fragile X Syndrome is also on track for data next year. Taken together, Mirim is entering a pivotal phase of growth as a leading rare disease company with multiple commercial medicines and several near-term potentially registrational readouts. Our team's strength continues to be its dedication to understanding patient needs and translating that into important medicines. Through this team's insight and hard work, we have now built a portfolio with over $4 billion in potential revenue. And with that, I'll turn it over to Joanne to walk through our pipeline in greater detail. Joanne.