Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) Q1 2024 Earnings Call Transcript

Bill Sibold: Okay. Jay, thanks for the question. We’re really excited, as we said in the call about the opportunity to expand geographically. And the EU is certainly a very interesting market for us. We announced in the first quarter, obviously, that we had filed. We’re now working through the strategy for the EU. And what we’re looking — and this is the way we’re making all decisions in the company. We’re looking at 1 3, 5 years from now. And where do we want to be? Where are we today, the realities of where we are today versus what we think we’re going to grow and become. We want to be the leading company in NASH, period. We think that’s achievable. And we think that, obviously, that’s going to come not only through Rezdiffra, but we’ll develop a pipeline, and that’s going to be geographic expansion.

So we’re working through those details. A little early for us to report out on them. We’ll come back to you on a later call and be more specific about what we’re doing in Europe. But it’s an exciting moment for us to be able to expand globally, and we look forward to reporting out to you on it.

Mardi Dier: Yes. The only comment I would make, Jay, because we are early in our decision-making there and mapping out the expenses that the investment that we would make, the payback will be would be within the 1 to 2 years. That’s how we look at our strategic decision-making. So there would be an impact likely if we get approval in ’25 and going into ’26 — pay itself back. And that’s just looking at Europe specifically. Clearly, the U.S. launch will cover a lot of the spend there in the EU.

Operator: Our next question is come from Ritu Baral of TD Cowen.

Ritu Baral: I want to dig in a little further about the non-invasive algorithm for pre-authorization that may be coming together in your insurance discussions. Per Yasmeen’s question, are you finding that things are mostly blood based? Are you finding that there’s a blood-based plus an imaging and which imaging is being preferred? And then how could that ultimately affect time to fill? Or how could these be affected by ASLP guidelines?

Bill Sibold: Ritu, thank you very much for the question. Really appreciate it. And look, it’s still early in the process. Generally, payers are evaluating a menu of the NIT. There isn’t 100% consistency across. And I think you’ve heard me mention even the community is still working through what’s the best sequence? What’s the best combination of NITs. I think that the guidelines have started to help with that. I think pending guidelines will hopefully again, provide additional comments on NITs. Regarding the availability, and I think you kind of hinted to that, we don’t see that as a limitation at the moment. Certainly, any of the decisions that we’ve seen, the positions in the area certainly seem to have access to those types of NITs between blood and imaging, it’s — I would say, it’s typically a combination of blood and imaging.

But as we have more final decisions and we have trends, we’ll be able to report out to you what that looks like. We’re really excited about updated guidelines, we know the community is working on them. I think one of the things we have to remember, the guidelines are pretty set. What you need to do now is put Rezdiffra into those guidelines. So we’re not expecting while differences were just they’ve been void of a treatment before, now you’ll be able to put Rezdiffra differ in there. But — so I guess the conclusion is still early we’re seeing the gamut, if you will, of NITs. And it doesn’t appear to be any kind of barrier to access to these in where the decisions have been made. So physicians can test them. And this will be a continued to evolve field as I think the community kind of really — now that they have a product thinks about how to use NITs, how to sequence and combined.

Operator: And our next question will be coming from Thomas Smith of Leerink Partners.

Thomas Smith: Congrats on the early launch progress. I wanted to follow up on some of the early payer coverage and specifically on the VA decision. Do you expect to still have any read-through to how any other commercial or government plans are likely to cover Rezdiffra, at least with their initial coverage policy decisions? And then how important are updates to the treatment guidelines with respect to the payer discussions? Have you received any feedback from payers suggesting that this could help drive either more favorable coverage or less restrictive prior off coverage?

Bill Sibold: Great, Thomas. Thanks for the question. First of all, I don’t think there’s a read-through there. We’re having independent conversations with each payer. And as I said, with the payers, especially the larger players that we’re speaking with, there is a true, true acceptance of the seriousness of the disease and appreciation to the clinical data and an appreciation for how we’re approaching the launch. So I think that they’re independent decisions. I mean people — payers all make their own independent decisions. So we don’t see the read-through. And the second question was the guidelines. Look, I think the guidelines are important. And as I said in the previous question, the guidelines that are in place are already being referred to.

I think it will be helpful for the physician community and the payer community though, to have updated guidelines that do contemplate Rezdiffra and provide a little bit more direction about how you would use it, when you would use it et cetera. So we’re — we know that the various bodies are working on it, and we’re hopeful that we’ll see at least something draft in the not-too-distant future.

Operator: And our next question will be coming from Akash Tewari of Jefferies.

Akash Tewari: So do we have any early color on the patient enrollment form? Are they exceeding your internal expectations? And when we think about rewiring of the system, Bill, you previously indicated we should not expect to see any significant revenues for Rezdiffra in 2024. Is that still the case? I just want to make sure we’re clear on what expectations are going to be. And then maybe if I could sneak this in, if semaglutide shows a fibrosis benefit that’s in line with Rezdiffra and its upcoming Phase III trial, do you expect GLP-1s to be step headed by payers ahead of your product? And would that affect your internal launch projections for next year?