Mirum Pharmaceuticals, Inc.

Hello and welcome to the MIRIN Pharmaceutics Report's first quarter 2025 financial results. My name is Carla and I will be coordinating your call today. During the presentation, you can register to ask questions by pressing star followed by one on your telephone keypad. If you change your mind, please press star followed by two. I would now like to hand you over to Andrew McKeown, Senior Vice President of Strategic Finance and Investor Relations to begin. Andrew, please go ahead when you're ready.

Thanks, Carla, and good afternoon, everyone. I'd like to welcome you to Miriam Pharmaceuticals' first quarter 2025 conference call. I'm joined today by our CEO, Chris Peets, our President and Chief Operating Officer, Peter Radovich, and Eric Buerkle, our Chief Financial Officer. Joanne Kwan, our Chief Medical Officer, could not be with us today as she's at a medical conference in Europe. Earlier today, Miriam issued a news release announcing the company's results for the first quarter 2025. Copies of this news release and SEC filings can be found 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. These statements represent our judgment as of today and inherently involve risks and uncertainties that may cause the 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-Q and the subsequent SEC filings for more information. With that said, I'd like to turn the call over to Chris. Chris?

Thanks, Andrew, and good afternoon, everyone. I'd like to start off by highlighting the tremendous progress Merim has made in the first quarter of 2025. We continue to deliver across our key strategic objectives, furthering the growth of our commercial medicines and advancing our high-impact pipeline. We are excited to share the details of another record-breaking quarter for Merim, with total revenues reaching $111.6 million, or 61% growth over the first quarter last year. Further, given how strong the year has started across the commercial business, we are updating our full-year revenue guidance to be $435 to $450 million. This increase is driven by robust growth from all three of our commercial medicines and highlights the Merum team's continued strong commercial execution. In addition, I'm happy to report we've received three important regulatory approvals since the start of the year, adding growth drivers to the business. First, Cetexly was FDA-approved for the treatment of CTX in February, and we've begun promotional efforts to reach this underdiagnosed community. Second, Livmarli was approved in Japan for Pfeffik and Allergil syndrome through our partner, Takeda. And most recently, a convenient single-tablet form of Livmarli was approved by the FDA. These milestones highlight our commitment to reach more patients globally. Our pipeline continues to make great progress as well. starting with the VISTA study of Elixabat and PSC, we are getting close to completing enrollment and now expect to achieve this in the third quarter of this year, with top-line data expected in the second quarter of 2026. As a reminder, both the VISTAs and Vantage studies successfully passed the dose selection interim analysis last year and are now in the confirmatory portions of the studies. As an example of what impact iDOT inhibitors can have in PSC, I'd like to highlight a recent presentation earlier this week at DDW of a case series of PSC patients receiving merolixibat through our Compassionate Use Program. Encouragingly, we saw reductions in serum bile acids, and all patients had a two-point or greater reduction in pruritus. PSC remains a condition with no approved therapies, and these results build on our conviction for the potential of elixibat to bring life-changing results to patients in need. Now, looking ahead, this Friday at EASL, we are also excited to present the updated 28-week interim data from the Vantage study in PVC, where Velixibat has been granted breakthrough designation. In this analysis, we show the rapid, deep, and statistically significant improvement of pruritus on Velixibat we shared last June is durable through the full 28-week study. In this updated interim analysis, Velixibat showed a 3.8-point reduction from baseline and a 2.5-point placebo-adjusted reduction in pruritus. We're excited to advance this program through the confirmatory portion of the study, and we continue to expect enrollment completion next year. And finally, for the balance of the pipeline, we remain on track to initiate our Phase II study for MRM3379 and Fragile X syndrome this year, as well as complete enrollment of our Liv-Marley EXPAND trial in 2026. 2025 is set to be another year of meaningful growth for Miriam as we continue to advance our commercial portfolio and pipeline. With strong execution and financial discipline, we are well positioned to continue our leadership in rare disease. And with that, I'll turn it over to Peter to give a brief update on the commercial business. Peter?