Madrigal Pharmaceuticals, Inc. Common Stock 12th Annual Cantor Fitzgerald Global Healthcare Conference
Review the key takeaways and the transcript of this earnings call.
- Madrigal reported $364 million in sales for Q2, placing it among an elite group of companies with blockbuster performance.
- The company crossed 50,000 patients on ResDevra by July, a significant milestone.
- The market for MASH is currently about 10% diagnosed, representing only 1% penetration, indicating a large growth opportunity.
- The target prescriber patient population grew from 315,000 at the end of 2023 to 460,000 at the end of 2025, showing nearly 50% growth in two years.
- Madrigal expects double-digit market growth for the foreseeable future.
- ResDevra has maintained steady patient additions of 6,000 to 7,000 net patients per quarter, even after the launch of competitor Wegovy.
- Real-world evidence shows ResDevra performing better than clinical trials, with physicians reporting high patient satisfaction and tolerability.
- Madrigal has reached over 10,000 prescribers, focusing now on increasing depth of prescribing through time, experience, data generation, and service model refinement.
- The company has excellent payer access with first-line access and no step edits despite the launch of Wegovy, maintaining gross-to-net protection.
- 2026 saw a meaningful increase in contracting and gross-to-net impact, with some additional but smaller impacts expected in 2027, including Medicare contracting.
- Madrigal views GLP-1s as appropriate for some indications but believes ResDevra is the preferred product for MASH due to its profile and real-world adherence.
- The company anticipates robust sales growth for the rest of 2026 and a strong setup for 2027 and beyond, with no specific guidance given yet.
- Upcoming competitive readouts include Inventivo in 4Q and an FGF21 readout in 2027, but Madrigal believes its real-world experience and product profile position it well against competition.
- The F4 cirrhosis (F4C) open-label study with 122 patients showed a 6.7 kilopascal reduction in liver stiffness over two years, with 65% of patients shifting to lower risk categories for portal hypertension.
- The annualized event rate in the F4C cohort was 2-3%, lower than the expected 5-10% natural history rate, supporting positive expectations for the phase three trial.
- The phase three trial is powered for a hazard ratio of 0.5, based on analogs in hepatology and the absence of a standard of care in cirrhosis.
- Madrigal estimates about 245,000 F4C patients in the US, with higher urgency to treat and potential to double the opportunity compared to earlier fibrosis stages.
- A positive F4C readout is expected to have a halo effect on F2 and F3 populations by increasing confidence in the product.
- Madrigal's pipeline includes an oral GLP-1 (Orphaglipron) in first-in-human studies, a DGAT2 inhibitor (Avergastat) licensed from Pfizer, and an siRNA targeting PNPLA3 licensed from Arrowhead, all anticipated to enter phase two studies next year.
- Phase two studies will be designed to evaluate efficacy and tolerability efficiently to decide which assets to advance to phase three, with a capital-efficient approach having spent about $300 million upfront on the pipeline.
- Management defines a mega blockbuster product as one with strong market dynamics and sales like the current quarterly $364 million run rate, indicating ResDevra's potential.
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Transcript
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All right. Welcome everyone to day 2 of Cantor's Global Healthcare Conference. My name is Prakhar Agrawal. I am a biotech analyst at Cantor, and for the next session, we are very excited to host the team of Madrigal. Joining us today, we have the entire management team, Bill, CEO, Marty, CFO, and David, Chief Medical Officer. Thank you so much for taking the time to join our conference.
Thank you. Bill, we can start off with just level setting expectations.
Coming out of 2Q, what were some of the key highlights for you internally on Rezdiffra's performance and things that Street fully didn't appreciate?
Yeah. Well, first of all, thanks for having us, Prakhar. We are really happy to be here. Q2 was a great quarter for us. If you look at it from any of the metrics that we share, starting with $364 million in sales, that puts us in a very elite group. When you take out some of the already mega blockbusters that exist, there's very few companies that could put up a quarter like that, with some differences, and I will get to that in a second. We also announced that we had greater than 49,000 patients. That was the end of Q2, but we also said that we crossed the 50,000 mark in July, which is a big. It is a significant milestone when you cross 50,000.
Now, the other piece, which is really interesting, and this is getting a little bit more to the what's underappreciated, I think that there's still a lack of appreciation for the market dynamics that exist in MASH. That 50,000 and that 364 million, just to put in context, we are in a disease that's about 10% diagnosed today and 10% penetration. That's 1% of the opportunity. We are at the very beginning of what could be a big market, and the market growth dynamics are certainly exceptional. We reported at the end of 2023 that there was about 315,000 patients that were sitting in the practices that we were going to be calling on, our target prescribers, and that number grew to 460,000 at the end of 2025, almost 50% growth in two years.
What we're seeing through the first half of 2026 is very robust market growth that's continuing. We said that we expect double-digit market growth for the foreseeable future, and that's certainly the case. I think the market is treating us at times like it's a mature market where you are in a zero-sum game for market share, et cetera. Instead of looking and saying, "This is a lot like some specialty markets that evolved over 20 to 30 years, RA, psoriasis, IBD," and those have become $20, even $30 billion markets. We feel that that's what's going to happen with the MASH market. The difference, we're the leaders, we have a first-mover advantage, and because of the success of the product, we've now built a pipeline which really leads to longer-term growth and success as well.
I think that it's sometimes you look at something and say, "Is it too good to be true?" Well, this is not too good to be true.
This is true. Yep. There was a big debate that GLP-1s are going to impact the volume, but you've been constantly adding 6,000 to 7,000 net patient adds in the past few quarters.
I feel like since Wegovy's launch, the patient adds have actually accelerated a little bit. What's driving some of that growth? Is it that now being in the market, just increasing the diagnosis rate, treatment rate? Just maybe expand on that.
Yeah. Well, look, a couple things. I think anytime you add a competitor or another launch to a market, it certainly helps with the growth of that market. We are seeing that. As I said, we are seeing a really robust growth continuing with MASH, with diagnosis, and Wegovy has helped that. What it has not done is it has not had any impact on the growth of Rezdiffra, and I think that really comes down to profiles. The Rezdiffra profile, you often hear me refer to it as kind of a holy grail profile, an effective, well-tolerated, safe, once-a-day pill. That has kind of been the gold standard, at least in my 35-year career experience so far, and that is what I think is driving a lot of the uptake of Rezdiffra. People are seeing that it has got a great profile, and even more importantly, the real-world evidence looks really good.
I think we look better than we did in clinical trials. That is the report that we got from physicians constantly are saying, "Patients are doing really well, even better than I would have expected." So all of that leads to this steadily adding comment that we have been making really for a number of quarters now that we have steadily added and expect to continue to steadily add patients, which is what we are going for here. You cannot fight certain dynamics of a new market. Rarely, and in fact, I do not think I have ever seen in my career where first product launches and every single patient just gets treated out of the gates. It takes time. Each physician, each prescriber has to go through their own checklist. They have to make sure they have got the resource to pull through a prescription.
They have got to make sure they know how to identify, how they source, how they create pathways. So it just takes some time. That is why we use benchmarking so frequently in our launch metrics, and on all the key metrics, we are at or near the top of those various metrics against other really successful specialty products.
Got it. You have talked about the increase in diagnosis rate as well since the Rezdiffra launch. I guess, where can it go at peak? Are there any analogs that you look at internally to really understand that, and any further steps you could take to increase that diagnosis?
Yeah. Look, as I said, some of that's just on a gradually you increase that diagnosis rate. Let me start with, that's why we were so specific and have been so specific about what the diagnosed population is that's at our target prescribers. Because that's ultimately what is the opportunity immediately in front of you. I'll get to the diagnosis in a second, but when you look at the 315 growing to 460 and growing well beyond that in itself represents an opportunity, which is a big specialty market if you were not to at all increase the diagnosis rate. So it's a way to give surety that, we have multiple paths to victory, so to speak. Now, when you think about diagnosis rates, it really depends. You look at the real high end, cystic fibrosis is over 75%.
If you look at something like psoriasis, sorry. You have the cirrhosis, psoriasis. Psoriasis after almost 30 years of products on the market is still in the upper 20s, I believe. Now, where do we land? It's not going to be up at the 75% plus just because it's not as visible a disease and so forth. But if you look at just even the lower end of that, you're talking about a population of diagnosed which could exceed 1 million plus people. So that's why us doing the counts and knowing who exactly is diagnosed and already there, and building our approach around that to take advantage of that opportunity is the approach that we've taken. But look, where it's going to land, I'm not sure, but is it going to be a lot bigger than the 460 today? Absolutely. Is it showing signs of that today?
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