Madrigal Pharmaceuticals, Inc.

Good morning, and thank you for standing by. Welcome to Madrigal Pharmaceuticals' first quarter 2026 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. As a reminder, today's conference call is being recorded. I would now like to introduce Ms. Tina Ventura, Chief Investor Relations Officer. Please go ahead.

Thanks, Brula. Good morning, everyone, and thank you for joining us to discuss Madrigal's first quarter 2026 earnings. We issued a press release this morning and posted a slide deck to accompany this webcast on the Investor Relations section of our website. On the call with me today is Bill Sibyl, Chief Executive Officer, Dave Sorgel, Chief Medical Officer, and Marty Deer, Chief Financial Officer. They will provide prepared remarks, followed by Q&A. Please note on slide two, we will be making certain forward-looking statements today. We refer you to our SEC filings for a discussion of the risks that may cause actual results to differ from the forward-looking statements. With that, I will now turn the call over to Bill on slide three.

Thanks, Tina. Good morning and thanks for joining us. 2026 is off to a terrific start. We've made impressive progress towards our strategic growth priorities to maximize the value of ResDifera and build our pipeline. ResDifera has achieved blockbuster status, generating more than $1.1 billion in net sales in the last 12 months. That's a billion-dollar run rate in a market that's still in its infancy. Penetration is low, the diagnosis rate is low, unmet need is high, and the market is expanding at a double-digit pace. When you put those fundamentals together, the future growth opportunity is quite remarkable. Competition has helped grow the market, but not at the expense of ResDifera. Beyond F2, F3, MASH, we're advancing our F4C outcomes trial, where an indication expansion could double the opportunity for ResDifera. And because we believe this is one of the most compelling opportunities in the industry, we've moved quickly to build the leading pipeline in MASH. We added to it yesterday with a new siRNA asset that targets a mutation in the PNPLA3 gene, a genetically validated driver of disease in a meaningful subset of patients. When you step back, it is hard to find another opportunity with this combination of market fundamentals and product strength. We have a first in disease approval, a foundational therapy, a rapidly expanding market, and we are building an industry-leading pipeline. We believe Madrigal is exceptionally well positioned to win here and continue to shape the future of MASH. I'll begin with an update on the ResDifera launch, hand it to Dave to discuss our pipeline and R&D strategy, and Marty will wrap up with a review of our financials. Turning to slide five in net sales, first quarter 2026 net sales were $311 million, representing year-over-year growth of 127%. This performance continues to reinforce that ResDiffer is tracking in line with, and in many cases exceeding, the best in class specialty launches we compare ourselves to. Over the last two years, we have wired the system to drive ResDiffer's growth. We built a large and growing prescriber base, secured first line access with commercial payers, and established ResDiffer as the foundational therapy in MASH. Combined with ResDiffer's differentiated profile, and strong patient adherence, our execution has enabled us to steadily add patients quarter over quarter as shown on slide six. We ended the first quarter with more than 42,250 active patients on ResDifera. On a year-over-year basis, patients on therapy increased by two and a half times compared to the first quarter of 2025. That is a significant achievement by any standard, but especially in a market that didn't exist before ResDiffers approval. This momentum reflects strong execution by the team, the clear unmet need in MASH, and continued demand from both prescribers and patients. And importantly, we are seeing that momentum carried into the second quarter. Slide seven shows how quickly the MASH market is expanding. Since launch, we've seen the U.S. addressable market grow nearly 50% from 315,000 patients at the end of 2023 to 460,000 patients at the end of 2025. These are diagnosed F2, F3 patients seen by our target specialists. ResDiffers approval, together with increased industry investment, has helped transform the market by driving greater awareness, referrals, diagnosis, specialist involvement, and more patients seeking care. And yet, this market is still in its earliest stages. The diagnosis rate is just over 10%, and resdifer penetration remains just under 10% of the 460,000 addressable patients. The match market has expanded rapidly, and the opportunity ahead is substantial. That gives us a clear path to peak sales, and we believe no company is better positioned than Madrigal to capitalize on it. But being first in a large and growing market is only part of the story. We have established this leadership position because ResDifera is delivering what the MASH market wants. And that is what slide eight highlights. After two years on the market, three things are clear. First, profile matters. ResDifera is the only approved liver-directed therapy in MASH. It has broad proven efficacy across all patient subtypes and is an oral, once daily, well-tolerated medicine with no titration requirements. In a chronic disease, this profile is a key reason why we continue to see strong persistence and increasing depth of prescribing. Second, real-world performance matters. Clinical trials get a drug approved, but real-world experience determines a product's success. With tens of thousands of patients treated, we've received overwhelming feedback from the community that ResDifera's efficacy continues to exceed expectations in the real world. This includes improvements across liver stiffness, liver fat, liver enzymes, LDL cholesterol, and LP little a. This is the kind of real-world experience that builds confidence with prescribers and helps establish a true standard of care. And third, We have built not only a leading product, but a leading MASH company. We have the right team, the right model, and the right start in a market we developed from the ground up. We have executed one of the best launches in the industry where our differentiated specialty model has set a high bar for anyone launching in this space. And we have learned, refined, and improved our approach along the way. We were first to market and now have a pipeline with more than 10 programs designed to extend our leadership over time. Our leadership is also reflected in our presence at key hepatology, gastroenterology, and endocrinology-focused medical meetings this month, with more than 40 resdifera abstracts being presented. This includes a poster presented at DDW this week where nearly 70% of risdifera prescribers surveyed said risdifera has improved their patient's quality of life and nearly 70% expect to increase their risdifera use over the next six months. Later this month at EASL in Barcelona, we will present additional data that reinforce the breadth of risdifera's effect. That includes a secondary analysis from our Maestro NASH and NAFL D1 trials showing that risdifera reduced LP little a and LDLC in patients with MASH, supporting its potential to reduce cardiovascular risk independent of baseline statin use, along with two real-world data sets that demonstrate ResDiffers' benefit in everyday clinical practice. We believe evidence generation is a strategic advantage for Madrigal. The more we can show prescribers and payers about ResDiffers' performance across clinically relevant endpoints, the more it's solidified as the foundational therapy. Everything we've discussed so far speaks to the strength of risdifera in F2F3 MASH, but there is another significant opportunity ahead of us in well-compensated MASH cirrhosis, or F4C, as noted on slide 10. It's an untapped market with no approved therapies and a much higher urgency to treat. We believe F4C could double risdifera's opportunity with approximately 245,000 patients under specialist care in the U.S. We have an event-driven outcomes trial underway in F4C that, if positive, is expected to support expansion into this indication, as well as support full approval across F2 to F4C. So, before I turn it over to Dave to talk about our pipeline, let me reiterate how rare an opportunity Madrigal has. We were first to launch, we rapidly achieved blockbuster status, and we are still at the very beginning of the development of this market. It's hard to find a comparable opportunity in the industry where the fundamentals are this attractive. And from that position of strength, we are now investing in the next wave of innovation to extend our leadership and define the future of MASH. With that, I'll turn it over to Dave.