Madrigal Pharmaceuticals, Inc.

Good morning, and thank you for standing by. Welcome to the Magical Pharmaceuticals Third Quarter 2025 Earnings Conference Call. At this time, all participants are in 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'd like to introduce Ms. Tina Ventura, Chief Investor Relations Officer. Please go ahead.

Thanks, Marvin. Good morning, everyone, and thank you for joining us to discuss Madrigal's third quarter 2025 earnings. We issued a press release this morning and posted a slide deck that accompanies 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, and then we'll take your questions. 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.

Thanks, Tina. Good morning and thanks for joining us. We have delivered another excellent quarter as we continue to execute on our strategic priorities. We're maximizing the value of ResDifera and building our pipeline, which sets us up for continued value creation. ResDifera is quickly becoming one of the most successful specialty launches in the industry, with sales now annualizing at greater than $1 billion in only its sixth quarter of launch. More than 29,500 patients are being treated with ResDifera, and more than 10,000 healthcare providers have prescribed it. We've made great progress on our 2026 payer contracting strategy for first-line access. Our new U.S. ResDiffer patent was listed in the Orange Book. It extends ResDiffer's value into 2045. And we're expanding globally with our launch in Germany following European approval. On the pipeline front, we're advancing our Phase III Maestro NASH outcomes trial in F4C, where we could once again be first to market, this time for compensated NASH cirrhosis. We look forward to sharing more from our F4C open label cohort at AASLD later this week. We're executing on our ResDiffer combination strategy, where we completed the transaction of our new oral GLP-1, and we continue to evaluate opportunities to add additional assets to our pipeline through business development. So today, we'll focus on our two key priorities, our top line and our pipeline. Starting with ResDifera's third quarter performance on slide four, we delivered net sales of $287 million, up 35% quarter over quarter. The significant demand we're generating is driven by the positive response to ResDifera from prescribers and patients and the strong execution by our team. As shown on slide five, we ended the third quarter with more than 29,500 patients on ResDifera, up from more than 23,000 patients at the end of the second quarter. This number represents patients actively on therapy, accounting for any discontinuations. As we've discussed since the beginning of our launch, we've been steadily adding patients each quarter, and we expect that to continue going forward. It's incredibly gratifying to see ResDiff are already making a meaningful difference for so many patients, but what's most exciting is that we've only just begun. More than 90% of our 315,000 target population remains untreated. That leaves tremendous room for growth driven by ResDifera's highly differentiated profile and our clear first mover advantage. Moving to slide six in our continued progress on physician penetration. As I've said before, building a strong prescriber base early in a launch is one of the best indicators of long-term success. That's why the pace of adoption has been so encouraging. This quarter, we hit another launch milestone, more than 10,000 prescribers. This breadth achieved this quickly is at the high end of the benchmarks we track, and it reflects the work we've done to wire the system. Looking ahead, our focus will increasingly shift to depth. This metric is already tracking at the high end of best in class launches. We're also continuing to enhance our targeting. While our efforts have mostly centered on hepatologists and gastroenterologists, we're seeing growing interest from endocrinologists. These are specialists with a deep expertise in metabolic health who are interested in res difference mechanism and its potential in MASH. In response, we've expanded our field team to further target this group. These efforts substantially started in the fourth quarter. On slide seven, let's take a look at how we see the MASH market evolving. We see clear parallels between MASH and other large chronic disease markets like IBD, rheumatoid arthritis, and psoriasis. Each of these evolved into multi-billion dollar categories through continuous innovation driven by new mechanisms and tailored treatment regimens that address diverse patient needs. We believe MASH will follow that same path. Today, this market is still in its early stages, essentially where those categories were two decades ago, but with one important difference, ResDifera's profile. As an effective, liver-directed, well-tolerated oral medicine, it far surpasses that of the other first-to-market products in those diseases. We believe this gives us a durable advantage and a unique opportunity to lead and shape the market's evolution, first with ResDifera, and next with the pipeline we are building. So, we welcome new entrants to this evolving market. WGOVI's recent approval in MASH adds momentum to a market that's just starting to take shape. As seen on slide eight, our focus remains on the 315,000 diagnosed patients with moderate to advanced fibrosis. NOVA was targeting a much larger population, which will raise awareness and drive more screening, diagnosis, and treatment. As a reminder, GLP-1s aren't new. They've been available for over a decade and are already used to treat the metabolic comorbidities that oftentimes accompany MASH. As we've reported, about 50% of ResDiffer patients are currently on or have previously been on a GLP-1. We also understand the limitations of GLP-1 monotherapy in MASH. Few patients reach and sustain a therapeutic dose and tolerability remains a real challenge. Real-world data show that 70% of obese patients discontinue within one year. New data to be presented at AASLD show similar discontinuation rates in patients with MASLD. So, looking ahead, we expect ResDiffra to benefit in two ways, as first-line therapy in a market that will expand and from the high real-world discontinuation rates of GLP-1s. We're in a strong position and are confident in ResDiffra's growth potential going forward. As we've already mentioned, it's ResDifera's best-in-class profile that gives us such strong confidence as summarized on slide 9. It is a liver-directed medicine that delivers consistent efficacy across F2F3 fibrosis, BMI, genetic makeup in patient subtypes, including those with type 2 diabetes, who comprise approximately 60% of the MASH population. It's also simple to use. It's a once-daily, well-tolerated pill with no titration requirements. That simplicity matters to providers, to patients, and ultimately to adherence. We continue to see strong adherence consistent with other well-tolerated oral therapies. The seriousness of MASH and ResDiffers compelling profile continue to resonate with payers. Our objective is to provide first-line access to patients, preserving treatment choice for patients and providers. And we're pleased to share an update on slide 10. We're making great progress with our payer negotiations for 2026, which to date have resulted in contracts for broad first-line access, no step-edit requirements, and improvements in utilization management criteria that are better aligned with clinical practice. Overall, the dialogue has been collaborative and productive, and discussions are progressing really well. Payers understand the seriousness of the disease, the unique clinical value of ResDepra, and the importance of access and choice for patients and providers. We've already achieved favorable outcomes with several national payers while continuing constructive dialogue with others. We're encouraged by the progress and expect contracts to be finalized by the end of the year covering the vast majority of commercial lives. Gross-to-net management remains a core component of our strategy and guides how we approach payer contracting. We started contracting in April of this year, and as we've said, It wasn't everywhere and wasn't all at once. In fact, through the third quarter, contracting had a minimal impact on gross to net, reflecting our disciplined approach. Now that we expect to have payer contracts finalized in the fourth quarter for either an immediate or a January 1st implementation, we expect the fourth quarter gross to net to be at the midpoint of the 20% to 30% range we had previously discussed. Starting in the first quarter and continuing throughout 2026, we expect our gross to net impact to be in the high 30% range, which is consistent with other innovative multi-billion dollar specialty medicines. So, objectively, we're in a great position. We are executing on one of the most successful specialty launches in the industry. With less than 10% of our target market treated, the growth opportunity ahead is substantial. We have taken a thoughtful approach to contracting, which provides for outstanding patient access and durable long-term growth. In short, this strategy paves our path to peak sales. Beyond the U.S., we are expanding access to ResDifera as shown on slide 11. We're taking a focused country-by-country approach in Europe and launched in Germany at the end of September. Just like in the U.S., the team is wiring the system for a first-in-disease launch. This requires educating physicians on the risks of MASH and the urgency to treat. We are also driving change in clinical practice to develop processes for patient identification, diagnosis, and use of non-invasive tests. This work happens practice by practice to help develop the infrastructure for sustained adoption. The team is off to a great start, and we anticipate our efforts will start to make an impact in 2026. Now, I'll turn it to Dave to discuss the second pillar of our strategy, expanding our pipeline to extend our leadership and build long-term value. Dave?