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

Bill Sibold: Okay. Thank you for the questions. Let me see if I can get through them all here. Look, we aren’t providing anything with patient numbers or initiations or anything at this point. So it’s just too early. I think it’s pretty clear in the call that I’m really pleased with the way things are progressing with the launch. Our focus is right now is really this wiring the system. If we don’t build a strong foundation, we will not be able to push through high volumes of patients in the future. A lot of companies make the mistake that they just try to chase getting patients on drug without preparing the practice, the payers and the whole system for being able to handle the flow, and we’re focusing on that. However, we are still having patients come through, which is really great.

So I’m very pleased where we are. I’m looking forward to as we get through the next quarters of being able to further wire and also to give you a report out on just how things are going. Your next question was about the expectations for revenues. Mardi, do you want to take that one?

Mardi Dier: Yes. So Akash, just to be really clear what we said, we said because of the time to wire the system and the time for prescriptions to be filled for the first 6 months, which we estimate on average 60 days. So we think that comes down to 30 days after 6 months, that 2Q sales will be modest. And that sales for the year will really be back-end loaded for Q3 and Q4. We haven’t given a number for that. We haven’t given guidance on that. But we are, we have validated and where the Street is at an average of consensus that we feel confident with. So that’s the message regarding revenues for 2024. And then the step at it.

Bill Sibold: I think, look, I guess we’ll find out more this year about if anyone manages to show the same impressive efficacy results that we have by hitting on both primary endpoints. Let’s see. So look, looking ahead to the future. regardless of what happens, what they show, I think you have to come back to the facts. The facts are, first of all, that there’s an incredibly high unmet need. There’s 315,000 patients, so there’s a lot of patients. And up until March I think there was not an approved therapy. Now what was the therapy that was approved? Rezdiffra. And look at that profile. Efficacy hit on both endpoints, greater than 80% of patients have a stop or reverse fibrosis. So the response is deep, and the response is wide.

So we have an effective product that happens to be a once-a-day pill that has been shown to be well tolerated and safe. So we’ve got a profile which is really a fantastic profile. I mean it’s every kind of drugmakers dream is to have a once-a-day pill for a serious disease. And I’ll take that profile and we will compete against anyone, especially since we’re at the beginning of the market, we’re not talking about a zero-sum game here, where market shares are all locked in place and one person is going to lose share, one person that’s going to gain it. We’re hopeful that there’s going to be other products in NASH because it helps to grow the market. And we think that with our profile, which is still emerging. Look, we only had — we’ve got a proven a 52-week data, and we saw this as a 54-month study.

We think some of the — our best days are ahead actually in showing what this product can do. So will they force a product for the patient to go through a GLP-1, I don’t know. We’ll see what they do. But I think that on our profile alone, there is a very compelling reason for patients to be on Rezdiffra. So we’re extremely confident under any scenario of what anyone else shows in data.

Operator: And our next question will be coming from Jon Wolleben of Citizens.

Jon Wolleben : Wondering if you could talk about the patient services you’re providing and if you’re expecting patients to start on paid therapy after those 60 to 30 days or if there’s going to be a lot of free drug in the system?

Bill Sibold: Okay. So Jon, thanks for the question. You mean the types of services that we’re going to offer or do you want more specifically how we see that mix of patients.

Jon Wolleben : I guess the latter is more informative, but if you could speak to the first — the former as well.

Bill Sibold: Yes. Look, so we’ve put together a very comprehensive patient support group. We think that’s really important. We think it’s important that the first interaction that they have with the product through patient support is important and establish as kind of a long-term relationship, hopefully helps them navigate any challenges they may have along the way. Through Madrigal patient support They get co-pay assistance, et cetera. If they are underinsured or have no insurance, they can qualify potentially for our patient assistance program to receive free drug, et cetera. So it’s important not only on the front end but also as you look over the long term, establishing that long-term relationship and helping through any kind of adherence challenges somebody may have.

So we fundamentally believe that a strong patient support services group is important. And we think that we’ve got really a great one that we’ve started. Regarding kind of free drug and so forth, look, you’ve heard me say before that as you look through kind of that first year, you’ve got patients that are — some are going to be on free drug. We’ll have a bridging program, et cetera. So it’s a little bit choppy if you’re thinking of it from a gross to net perspective for that first year. What we’ve committed to the community is this whole notion of equitable access. We don’t want to — we want to be able to provide product to patients who need it. So we’ve focused on affordability for patients. If you’re a commercial patient, you can have a $10 co-pay.

The challenge right now is with Medicare, since we missed the window for ’24, we’re now talking about what will happen in ’25. So those Medicare patients are either going to have an opportunity through their own plan if they’ve made a midyear decision or some of them are going to have to wait for 2025. So we’re going to try to help those patients. We’ll look to see if there’s alternatives for them such as charitable foundations, et cetera. And in the end, if they can’t get it through other means and they have a high unmet need will provide a free product. So we will have free patients. But that’s not where we are today. We have patients that are coming through the system and they’re paid prescriptions. So we feel like we’re in a really good place, but we’re always going to have this balance of some patients for structural reasons, won’t be able to get drug through that means we’re going to help those patients.