Madrigal Pharmaceuticals, Inc.

Good morning and thank you for standing by. Welcome to McGregor Pharmaceuticals' fourth quarter and full year 2025 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.

Thank you, Michelle. Good morning, everyone, and thank you for joining us to discuss Madrigal's fourth quarter and full year 2025 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 Sibbles, 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. Today I'll provide an update on the ResDiffer launch where we ended our first full year on the market at nearly $1 billion in net sales and solidified Resdifera as the foundational therapy in MASH. We'll discuss the significant growth in the U.S. MASH market, which is up nearly 50% since the end of 2023 and growing at a double-digit pace. And then Dave will provide an update on our R&D strategy, where we now have more than 10 programs in our pipeline. Before turning to our fourth quarter results, I want to reflect on what we accomplished in 2025 and in just the first six weeks of this year. In a remarkably short period of time, we built the leading company in MASH and assembled a pipeline we believe will help define the future of this category. We continue to execute on a fantastic US launch, extended ResDifera's patent exclusivity to 2045, and initiated our ex-US rollout beginning in Germany. We're advancing our F4C trial for ResDifera, and we're accelerating evidence generation to further differentiate the product. At the same time, we moved quickly to build a high-quality pipeline around res difera, completing three transactions in roughly six months, adding an oral GLP-1, a late-stage DGAT2 inhibitor, and a portfolio of six preclinical siRNA targets, each designed to be studied in combination with res difera. The reason we're moving with this level of urgency is simple. Assets like res difera don't come along often. We have a high-quality, high-growth foundational therapy driving strong top-line performance with patent protection into 2045. When you have an asset like that, you have an opportunity to build a sustainable and durable franchise for the long term. That's exactly what we're doing. ResDiffra gives us a unique ability to pursue combinations, to attract high-quality assets, and to shape the market in ways other companies simply can't. As a result, we are fundamentally a different company today than just six months ago, transitioning from a single asset launch story into a fast-growing biotech with a pipeline designed to extend our leadership for years to come. Let's turn to net sales performance on slide five. We delivered fourth quarter 2025 net sales of $321 million, more than tripling fourth quarter 2024. For our first full year on the market, net sales totaled $958 million, an exceptional launch by any industry standard. That nearly billion-dollar result took a lot of work. We didn't just launch a product. We built a market from scratch. Let's take a second and really think about that. Remember, MASH was long viewed as the graveyard of drug development. No treatments, no market, and skepticism that one would ever exist, particularly with GLP-1s on the horizon. We took a different view. The unmet need was substantial, and demand for an effective therapy was real. We believed in the science and Red's ability to become the standard of care. We built the right team, people who have created categories and launched blockbuster brands, and we got to work. We executed with a long-term mindset, wiring the system practice by practice, educating prescribers, establishing care pathways, expanding prescriber breadth and depth, and securing first-line access through discipline contracting. And we continue to iterate and improve. The results speak for themselves. We were first to market, and that matters. ResDifera, with its liver-directed and differentiated profile, has established itself as the foundational therapy in MASH. The market is real and only beginning to take shape. GLP-1s are here, and as we expected, we're still steadily adding patients. There's room for competition, which we believe will further expand the market, and we are building a pipeline designed to extend our leadership over time. As a result of the foundation we've built and our large base of prescribers, we continue to steadily add patients quarter over quarter as seen on slide seven. Remember, the number we report reflects the net of new starts and discontinuations at the end of each quarter. We continued to steadily add patients ending the fourth quarter with more than 36,250 patients on ResDifera, up from more than 29,500 at the end of the third quarter. That tells us two things. First, ResDifera's profile is exceptional and resonates very well with prescribers and patients. Second, this large and expanding market is capable of supporting multiple therapies. This represents a small fraction of the growing addressable population, and we expect to continue to steadily add patients quarter over quarter going forward. Let me spend a moment on the U.S. MASH market on slide eight. We are still in the early stages of what we expect to become a large specialty market. In just the last two years, the F2, F3 target population of 315,000 representative patients seen by our target specialists has expanded nearly 50% and we expect this market to grow at a double-digit pace for the foreseeable future. ResDifera's approval and increased industry investment across the ecosystem has fundamentally changed the market dynamic, driving increased awareness, diagnosis, referrals, specialist involvement, and patient-seeking care. This is a category in its very early stages where ResDifera is now established as the standard of care. As the market expands, we expect to benefit from its growth, increased penetration, and ultimately the introduction of additional therapies from our pipeline. MASH is a rare opportunity in biotech. Few therapeutic areas offer this combination of scale and high growth potential. That's why we expect MASH to follow the trajectory of other large specialty markets as shown on slide nine, markets that support 10 to 15 plus therapies, and have grown over decades to exceed $20 billion in annual sales. We believe MASH will evolve the same way, with one important difference. We are first to market with a product that has an unmatched profile. As an effective, liver-directed, safe, and well-tolerated oral medicine, it far surpasses the profile of first-to-market products in those other categories. And we continue to hear from our prescribers that ResDiffer is performing even better than expected in the real world. This profile positions us well to expand into compensated MASH cirrhosis, or F4C, the next phase of our growth strategy outlined on slide 11. We believe F4C could double RIS differs opportunity with approximately 245,000 patients, no approved therapies, and a significantly higher urgency to treat. Assuming regulatory approval, we expect to be first to market in F4C. Importantly, our F4C trial focuses on clinically meaningful outcomes, preventing decompensation, rather than relying on biopsy. ResDifera would be the only medicine with outcomes data solidifying it as the standard of care in MASH and supporting full approval across F2 to F4C. Before I turn it over to Dave, I want to briefly outline how we see the MASH market evolving and why Madrigal is uniquely positioned to lead it by building on the pipeline strategy that I described earlier. MASH is a complex, heterogeneous disease. Over time, we expect distinct patient subpopulations to emerge, each requiring different mechanisms, combinations, and sequencing approaches, all anchored by ResDifera. We've seen this evolution before in other diseases, where progress was driven by matching the right combinations to the right patients. That's the model we're pursuing in MASH, and it's why we've moved quickly to add these specific assets to our portfolio. And the reason we can execute on this strategy is our high confidence in the growth potential of Reddifera. We're able to build an industry-leading MASH pipeline because we have an outstanding product, one that is performing exceptionally well today and is positioned for continued strong growth. That strong foundation allows us to develop the next generation of MASH therapies for patients. That's exciting, and it's a true differentiator for Madrigal. Dave, I'll turn it over to you to walk through our R&D strategy.