7/30/2026

speaker
Operator
Conference Operator

Good morning, and thank you for standing by. Welcome to Magical Pharmaceuticals' second quarter 2026 earnings conference calls. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will have to press star 11 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference call is being recorded. I would now like to introduce Ms. Tina Ventura, Chief Investor Relations Officer. Please go ahead.

speaker
Tina Ventura
Chief Investor Relations Officer

Good morning, everyone, and thank you for joining us to discuss Madrigal's second quarter 2026 results. 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 Sibold, Chief Executive Officer, Dave Soergel, Chief Medical Officer, and Mardi Dier, 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.

speaker
Bill Sibold
Chief Executive Officer

Thanks, Tina, and thank you all for joining. Before we review our second quarter results, let me remind you why we're so excited about MASH and why we believe Magical is uniquely positioned to lead this market. The market fundamentals are exceptional. MASH is a high unmet need disease with the potential for decades of growth given today's low diagnosis and treatment rates and a rapidly expanding patient population. We are at the forefront of one of the most attractive growth opportunities in the industry. We also have what we believe is the foundational therapy. Resdifra is the first approved medicine for MASH, a liver-directed, once-daily oral medication with demonstrated efficacy across each MASH subgroup and an outstanding real-world profile. Add to that our commercial execution, our experienced team, and our industry-leading pipeline. We believe Magical is exceptionally well-positioned to lead in MASH today and define where this market goes over the long term. Slide 4 summarizes how we're executing on our two strategic growth priorities, maximizing the value of ResDifera and advancing our pipeline. ResDifera continues to exceed expectations as we steadily add patients quarter over quarter. Over the last 12 months, ResDifera has generated nearly $1.3 billion in net sales, reinforcing its mega blockbuster potential. We're also strengthening the long-term value of the franchise. A key pillar of that strategy has been to build a robust patent estate. Last year, we secured our pivotal 2045 F2F3 patent. This month, we build on that foundation with three additional patents, two that reinforce our protection in F2F3 and one supporting our potential F4C indication. As we've done successfully to date, we'll continue pursuing IP that protects the future of RISDFRA. And because we believe Red Differ is the foundational therapy in what will become a large specialty market, we're investing behind it. In less than a year, we've built what we believe is the industry-leading MASH pipeline, adding more than 10 programs. We now have four clinical stage assets following the initiation of the Phase I study of our oral GLP-1 last month. Each of our programs is designed to build on ResDifera's foundation and extend our leadership in MASH for years to come. We've accomplished a tremendous amount in a short period of time, but we're just getting started. Our team continues to execute on these priorities to strengthen the leadership position we've established. Let's move to our Q2 results, where I'll provide an update on ResDifera. Dave will discuss our pipeline, and Mardi will close with a review of our financials. Turning to slide six and net sales, we are continuing to see strong demand for ResDifera. Second quarter 2026 net sales were $364 million, representing year-over-year growth of 71%. This performance continues to reinforce that ResDifera is tracking in line with, and in many cases exceeding, the best-in-class specialty launches we compare ourselves to. Our strong performance is a result of successful launch execution. It's driving our near-term results and building the foundation for the long-term growth. We have effectively wired the system to build a broad and durable prescriber base. And importantly, prescribers continue to tell us that ResDiffer is performing even better in the real world, and that experience is translating into action. Today, our target specialists are prescribing risdifera more often, which is driving greater deaths across our prescriber base. That growing depth combined with broad first-line commercial access, risdifera's differentiated profile, and strong patient adherence continues to drive patient growth. That's why we've steadily added patients ending the second quarter with more than 49,000 active patients on risdifera, more than double a year ago. Importantly, Momentum remains strong as we progress through the third quarter, where we surpassed the 50,000 patient milestone earlier this month, a significant accomplishment in any launch. One of the things we're most excited about is how quickly this market is developing, as shown on slide 8. From year-end 2023 to year-end 2025, the U.S. addressable market has grown nearly 50%. from 315,000 diagnosed F2, F3 patients at our target specialists to 460,000. That's remarkable growth in just two years, and it's being driven by exactly what you'd expect in a new therapeutic category. Greater disease awareness, increasing diagnosis, more patients being referred to specialists, a growing urgency to treat, and increased investment by multiple companies. We have continued to see strong market growth again this year and expect the MASH market to expand at a double-digit pace for the foreseeable future. In fact, we see parallels between MASH and other large chronic disease markets like rheumatoid arthritis, IBD, and psoriasis, as shown on slide 9. Each started with one or two therapies and evolved into markets supporting more than a dozen products and more than $20 billion in annual sales. We believe that MASH will follow the same path and that Rizdifera has a stronger profile than the first products that launched in any of those categories. And today, we're only about 10% penetrated in a market with a roughly 10% diagnosis rate. Think about that. 10% of 10%, that's 1% of the total potential market. Yet even from that starting point, as shown on slide 11, ResDiffra is already generating north of a billion dollars in trailing 12-month net sales. That's why we're so excited about the future. We are still at the beginning of what we believe will become one of the largest specialty markets in the industry, where we have a first-to-market medicine with a best-in-disease profile. Everything I've discussed so far speaks to the strength and opportunity of ResDifera in F2-F3 MASH, but there is another significant unmet need ahead of us in well-compensated MASH cirrhosis, or F4C, as noted on slide 12. It's an untapped market with no approved therapies and a much higher urgency to treat. With approximately 245,000 patients under specialist care in the U.S., we believe F4C could double ResDifera's opportunity. We have an event-driven outcome trial underway in F4C that, if positive, is expected to support expansion into this indication and support full approval across F2 to F4C. And we see the market evolving beyond these initial stages as noted on slide 13. Like other complex chronic diseases, treatment will evolve to include multiple mechanisms, combination regimens, and increasingly personalized approaches. That's why we've strategically invested in building the industry-leading MASH pipeline. ResDifera gives us a foundation no one else has, allowing us to thoughtfully add complementary mechanisms that can provide even more efficacy, broaden patient reach, and define the next generation of MASH therapies. And one of the reasons we believe ResDifera is foundational is what we've heard consistently from prescribers over the last two years of launch. They not only value its liver-directed efficacy, well-tolerated profile, and once-daily dosing, but appreciate that ResDifera works across each patient subgroup in clinical practice. That breadth and consistency across patient subgroups is exactly what you want in a foundational medicine, and it's unique to ResDifera. Dayton will talk more about this in his section and share key data demonstrating where it differs broad efficacy. So with that, I'll turn it over to Dave.

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