Madrigal Pharmaceuticals, Inc. (MDGL) Earnings Call Transcript & Summary

Hi. Good afternoon, everyone. Thank you so much for joining us here. I'm Ellie Merle. I'm one of the biotech analysts here at UBS. Very happy to have Madrigal Pharmaceuticals here with us today. Joining us from Madrigal is the new CEO, Bill Sibold, Chief Executive Officer. Thank you so much for joining us during what appears to be a well-attended happy hour. I was told to now call this a fireside chat. And so with that, I'll turn it to you and ask what led to your decision to join Madrigal?

Well, Ellie, first of all, thanks for having me, having us here. It's a real pleasure to spend some time. Look, I'm 7 weeks into the new job. And I have to say, I've been waiting for that moment where I say, "Boy, is this the right thing to do?" And I can tell you, along the whole way, it's getting more and more exciting. I think it's very rare in the industry to have an opportunity where there is a disease of such high unmet need. That has absolutely no solution for it. And you've got a company that against all odds has brought forth an incredibly robust development program, and has a product that in trials appears to be effective, safe, well tolerated and a once-a-day oral and is liver directed in a disease of the liver. So to have a potential to be the first product to launch and to create a market. I think that's as good as it gets in this industry. And kind of my learning over the years is that success is built around great assets in a company. Whether you're the biggest company or the smallest company, a great asset kind of set you forward. And I'd much rather build a company around a great asset than to just be dabbling over years with the pipeline and hope that something hits. So the chance to build one in a thousand that makes, it is really what drew me here.

Maybe tell us a bit about your experience at Sanofi and particularly, the experience that you can leverage in launching resmetirom in the NASH?

Yes, I had a long stay at Sanofi, and it goes back to 2011 and came on board to build multiple sclerosis franchise. This was just after the purchase of Genzyme. So I was always in the Genzyme business unit. And we went from about a $1.5 billion in sales to $16.5 billion last year, 48 consecutive quarters of double-digit growth, 11 launches. And the most interesting one was DUPIXENT. So there was an opportunity to really build a brand -- a significant brand, one of the biggest brands in the industry from scratch. And I look at a lot of the parallels and no launch is the same. And it's kind of the learning from each of the launches that you begin to ask the right questions to say, how would you approach this launch in NASH? So for me, it's more of the experience of what to ask, how to think about, whether the -- how do you look at the unmet need, how do you target what's the right patient, et cetera. So all those learnings is what the plan is to bring to Madrigal. And really it starts with having the right -- first of all, right product. You need a great product, and then you need the right people to put in place. And so we're in the stage now where we're building a team that is going to be capable of launching a truly, truly great asset.

Absolutely. And look, there's a lot of controversy over the size of the NASH market opportunity. How are you thinking about it? And you mentioned your excitement about the market opportunity and in joining Madrigal. And yes, I mean what are people getting wrong? What gives you confidence in the size?

Well, I think that it's been this unmet need market for so many years, and there's been so many attempts. I think there's over 20 programs ahead of ours that have failed. And it starts to get that reputation of kind of that sepsis market or scleroderma, et cetera, where there's been just this track record of failure. So I think people absolutely understand the unmet need. When we talk to physicians about the unmet need, they don't have anything for the patients. They say, go home and change your lifestyle, lose some weight. And so I think what people see is this wonderful unmet need. But because nobody has been there, it's very hard to visualize that market developing. And until there's a product that's approved and grows and shows there's a market, others are going to stay on the sideline. I mean, I think there's a lot of research and development going on there now, but it's certainly not to the extent that it could be. And what we're hearing from physicians as well is they really are hoping we're successful because they know that will lead to additional companies coming in and driving the science forward, which I think is really good. Just thinking the potential size of the market, we're taking a specialty approach to this. So we're going to be focused on hepatologists and gastroenterologists, where there's patients that have NASH with significant fibrosis, which is an F2, F3 type of patient. And we know in talking to the clinicians that they have practices full of these people. Now when -- just to give you some ideas of the numbers, there's about 1.5 million diagnosed NASH patients in the United States. And about 35% to 40% of those have an F2 or F3. So now what our job is to say, well, where are those patients sitting in those practices and to target that way. So we're going to be coming back with a higher level of precision of just what do the numbers look like, who are the target physicians, what do we think is there to be able to give a little bit more clarity. But it is certainly a high unmet need market, nothing there. And as the first therapy, I think we really get to set the tone.

And I guess, where do you see resmetirom fitting particularly across the different patient segments, physician population? And first treatment in NASH, but there are GLP-1s. And so how do you see resmetirom fitting in that context?

Yes. Look, so I mean, we're going to be very specific for these most in-need patients, these F2, F3 that have significant fibrosis. That's where we did the clinical trials, right? And that's where the data supports the use of the product. We don't think just everyone should get it. We're not looking at that earlier, F1, F0 type of patient. It's just this is patients that you have significant fibrosis. And you're on that pathway to then moving to F4, well-compensated cirrhosis and then decompensated and that is -- your next stop is transplant, bad cardiovascular outcome, liver cancer. Not a good path to be on. So we really want to hit patients -- or I should say, target on patients, hit those livers that are starting to have fibrosis in a significant way and prevent the bad outcome. And I think that, that's -- I think it's a pragmatic approach. It matches our study population. It's where there's the high unmet need, and it's those patients that are making their way into the specialist office that understand the liver and understand what to do or they will once we launch the product. And when you say, where does it fit? Well, as the first product, it's going to fit, I think, very well, right? There is nothing else that's going to be approved. Other programs are generating data but they're still a long way from being to market. Now you specifically mentioned the GLP-1s, I think that's interesting. There's been, I would say, a lot of discussion, obviously, about GLP-1s in the broader context of not only weight loss but downstream effects to other industries even. A few things I'd say, we're liver-directed. We -- resmetirom works on the liver. GLP-1, the hope is you take away weight and therefore, you ultimately have an effect on the liver. I think there's always going to be a need when you have a patient that's already in this kind of more serious state. You want something that is going to be work well, work fast, has a track record through clinical development, et cetera. GLP-1, you do have a dosing titration schedule, 20 weeks plus, that's in clinical trials. One of the things we've heard is that it takes longer than that because of tolerability and so forth. So I think that there will clearly be a place if they show effective data in the future. But that's, I think, going to be a little bit more of a how do you try to prevent through dealing with patients that have -- that are overweight, whereas we're going to be focused on these patients that are already there at the clinicians. And just some of the numbers as well, there's about 110 million obese Americans. And if you look at any of the potential forecast of the GLP-1 class, if you call it 100 billion, that could represent 10%, 20% penetration. So you've got 80 million to 90 million obese people that still have all the potential risk factors that could ultimately lead to things like type 2 diabetes, lead to NASH. So I look at it that, this is a big enough market. There's enough people coming in that are going to end up with NASH in that F2, F3 significant fibrosis. The designation that we are, as the first mover really in a great place to build a market and take advantage of that.

Absolutely. And maybe just -- I know you joined 7 weeks ago. So I know launch preparations are probably more of a planning stages now. But I guess, as you approach your launch preparation, what are your top priorities? And what are you most focused on in terms of across education, building a sales force and planning that out?

Yes. I mean, look, prelaunch, first thing is get approved. That is really the objective, which I'm very confident about that. So it is starting to build the team, make sure they have the right people in place, have a clear defined strategy. And as you look at that, I think the strategy is very defined. Specialty launch focused on hepatologists and gastroenterologists, focused on patients with significant liver fibrosis F2, F3, now we build the team around that. And we're just taking the steps that you take in advance of a March 14 PDUFA date. So we have the medical teams that are deployed, sales, leadership and teams ultimately come in, and all the other supporting cast, if you will. So that's where I can rely upon the experience of having prepared for 11 different launches, what's the right sequencing and timing. And so it starts with what's the right team to be ready to launch the product.

How are you thinking about diagnosis? I think you mentioned about 35% of the 1.5 million people that are diagnosed are believed to have F2, F3. What do you think the true number is? And how many of these people are under care right now?

Well, I think that at the moment, when there is no approved product, there isn't the urgency to diagnose. These people have comorbid conditions. They have a list of ICD-10 codes. Is there really a need to have them have another one? I think that as you look at diagnosis as well, the NITs or the noninvasive tests, which are made up of blood tests as well as imaging, et cetera. Right now, there is no completely defined ultimate test or test sequence that says, this is the patient. They're all very accurate and all very good. And it's just people are still deciding what's the best sequencing to use. And I think that when you look at today, it's going to be different than post approval where people say, "Now, I'm going to use these tools." And they already do, that's the way patients are ending up at hepatologists and gastroenterologists. They do something like a FIB-4, which is a blood test. They do a FibroScan, which is essentially an ultrasound, measuring liver stiffness. If they are looking like they have disease, they then get referred. I think that the community is only going to get better and better utilizing the various tools like MRE, MRI-PDFF, ELF test. And where we are today versus 3 years and 5 years, I think it's going to become much better defined. It will be part of guidelines, et cetera. There's already some good guidelines to say when should you be concerned, but what's missing right now is where is the therapy in that mix. And I think that's what you're going to see evolve. And again, as the leaders of the first, we've got an opportunity to really help be a part of that conversation and take a leadership position in NASH and work with the community to find that path forward.

Absolutely. And you alluded to this before, but where do you think physicians are, maybe breaking it down between hepatologists and gastroenterologists that you said are going to be your target prescribers? Where do you think they are in terms of awareness and seeing NASH as a disease that needs drug intervention versus saying, "Hey, go home and diet and exercise or hey, here's a GLP-1?"

Yes. Look, I think there's a very high awareness in the physician community of NASH just because they're confronted with that -- with it so often. And right now, as you say, they don't have a good solution for patients. So I think that there is this -- there's an understanding of it. I think there is anticipation of the first therapy coming through. I think there's a little bit of nervousness, disbelief. And they don't want to get their hopes up too high because they've been disappointed so many times. It's just like, I think, when you look at kind of investors and so forth, it's very difficult to see a market emerge that isn't here yet. And I think physicians, they are -- they know the unmet need that exists. But until there's a drug, they just can't put their hands around it. So I think -- as soon as there's approval, people will begin to really see the patients in their practice more. And I just -- by that, I mean, they'll become more visible. And then ultimately, referral patterns will improve. All the testing will improve, and there will be kind of a system well wired to process patients for resmetirom.

The patients are, I guess, diagnosed somewhat and under care right now. What does this look like after a theoretical launch? I mean is there a group of patients and maybe we can debate the size of say, waiting -- eagerly wanting something?

Yes. I mean it's a little bit -- this is where you got to look at the specifics of the disease. This isn't a symptomatic disease where someone is walking around -- if you have somebody, for instance, most recently with eosinophilic esophagitis, you can't, right? You can't eat or if you've got atopic dermatitis, you're itching all the time. So it's not as though you're feeling the effects of the disease until it's too late. And once -- if you become decompensated cirrhotic, it's miserable, and it's a really bad outcome. I think there's been a reticence to even tell patients how bad the outcome could be. If I sit and I tell you, look, you've got fatty liver and you could have liver cancer or you could have a cardiovascular event or you could need a transplant. That's not so motivating when you then ask me the question, well, what can I do about it? And you're like, well, nothing. So I think that you're going to begin to see just the more conscious effort to educate a patient and we'll be a part of that as well about what are the consequences if you will, and that it would make sense to be on a therapy to prevent or reverse the fibrosis.

Okay. How large of a sales force do you think you need?

Well, look, it's the specialty size sales force. I'm not getting into the absolute specifics. But it is something that as a company our size, we can, I think, target extremely, extremely well with the physicians that have the -- we think that the bulk of the patients that are most in need.

And on the other side of the equation, the payers, maybe we could talk a bit about potential for biopsy being required. And I guess, what we know about it so far and how you're thinking about that?

Yes. We don't expect that a biopsy would be required. I think especially -- so if you look at a AASLD starting this week, one of the presentations we have, it looks at the NITs and there how good they are at both kind of diagnosis and watching kind of -- and monitoring the progress of the patient with NASH. So I think it's just not practical to expose a patient to the risk associated with a liver biopsy. It's something that it's not pleasant for the patient. The accuracy is not definitive. It's not great. And the use of NITs, as we talk about in this upcoming presentation, do a really, really great job of identifying the patients that are most in need and just kind of where they are on the spectrum of things. So we're not anticipating that, that is going to be any kind of a requirement from payers. I think that, that would be a real vote against trying to help people that have a very serious condition. I think as I said, it's going to take some time for the -- not the development of technology, but how do people feel best about sequencing and blending the use of NITs to have the most accurate results.

Have you had any initial conversations with payers?

Yes. Payer conversations have been ongoing a lot of times. Right now, it's just about here's what the unmet need is just so people understand the disease. It's one of those things until you're confronted with the disease you don't think about it too much. You think about the other ones. So we're spending time, making sure they understand that, making sure that to the extent that we can discuss with them the profile of the product, et cetera. So I'd say that there have been constructive discussions to date. Look, I think the reality is there's no product that launches that you don't have long discussions with payers about, right? And I think it always is better. A couple of things: one, you have an innovative product that works. You have an innovative product that if it shows cost effectiveness certainly helps you. There was an ICER report that was -- that came out earlier that, I think, really spoke to the benefit of resmetirom. And there aren't too many products that have the ability, especially prelaunch to have assembled enough information that you have such a good report. So we're going to -- we feel that we have kind of the right tools, if you will, the right data on our side to have productive conversations with the payers. But like anything else, there's not a payer conversation that doesn't have some tension associated with it.

Anything surprising so far?

Since joining?

Or with the payers?

With the payers?

Yes, maybe that's, yes.

No. I would say no, nothing surprising. It's just there's nothing surprising. It just takes time, right? People, they have to have the time to understand, and we've got to be there to be able to tell them the extent of the data that we have. The only thing I'll say is we have a really, really great comprehensive development program. And I think we've set an extremely high bar for all other programs to come. And that is helpful. Data is helpful. And I think that we have data from the clinical trials. We have health economics data that is based on the trial work and outside real-world evidence that is, I think, going to be extremely -- have us looked up upon favorably. Other surprises, I'd say the surprise is that being this far into it, I'm more excited than it was when I started on day 1 and made the decision. I've absolutely no doubt but this is just a unique incredible opportunity and just had a great time.

Great. Love to hear it. Maybe philosophically, and also after assuming where you had some conversations with payers, some maybe with tensions, others maybe that were unsurprising and going as expected. How do you think about pricing and what the considerations would be there? Anything in the label that could affect how you price the drug? And then maybe just any existing therapeutics that you think would be maybe or classes that would be good comparators or basis points when thinking about pricing?

Well, I guess a couple of things. First of all, from a label perspective, it's too early to make any comments on the label. From a pricing perspective, we will announce price upon approval. We're still looking at it. Again, as I said, this is a specialty launch focused on patients in most need. And I really believe that a medicine should be priced based upon the value that it provides. So we -- it's hard to find a real comparator to this product because there isn't really a good comparator to it right now. But I think I'm really optimistic that we'll land on kind of the right price. But you'll have to wait until we get to launch.

Okay. Understood.

You can keep asking. Everyone's been asking this question. The answer is the same. So just -- we're not too far away. I mean, March 14 is really just around the corner.

How are the regulatory interactions with the FDA going? And any color you can give us on the process and where you are?

Yes. Look, I mean, we announced the priority review. We announced that PDUFA was March 14, that no AdCom was necessary at that point. So I would say or I would summarizes that regulatory conversations have been productive. And I don't have any other real details in that. What I will also say is that we're planning for success. All the launch planning that I'm doing and the building -- we're building around the March 14 date. So as I said, I think it's a highly approvable product. Again, I think the one question that you may ask is what about any cycle extensions and so forth? Look, that's an FDA review timing issue more than anything. If you take a look at a lot of the products now, some do, some don't have them. It just depends on, I think, the size of the file and the speed in which FDA can move through it. Kind of your guess is as good as mine, but my approach is to plan on March 14.

Absolutely. I know when the filing was accepted, it was said that the FDA is not planning to have an AdCom at that time. I guess how are you thinking about that from a scenario planning perspective? Do you still prepare in case they change their mind? Or...

Yes. I mean look, I think the best thing to do is always be prepared, right? You do yourself no favors if you have hope as a strategy. I always believe in prepare if they change their mind and they wanted to do that, we'll be ready. If they don't want to have one, that's fine too. It's always good practice for the team.

Is it possible [ you can do ]? I mean how are you thinking about the likelihood of that?

You know what? I really don't have any sense of -- I'm just all I can listen to is what the FDA had said, which is that there wasn't one needed at that time. So let see.

I apologize. I still keep asking that.

No, I mean, look, I don't have -- I really don't have anything else that can provide any direction.

Going back to the conversation about biopsies. A question I get a lot is, will there be a biopsy requirement in the label or something that specifies something that indicates the diagnosis is done via biopsy.

I think that would be highly unlikely. It's just -- I don't think FDA typically wants to tell doctors how to diagnose and do their job. So certainly not expecting it. And similarly, not expecting that it's a part of reimbursement criteria or any utilization management criteria. But it just -- gee, biopsies themselves are certainly not perfect indicators of disease severity. I think what you're going to find again is through the use of these NITs, you're going to be able to get a lot closer to the precision of what's the status of the patient's liver or their NASH in this case. So I think that's why I don't think biopsies are going to be practical or pragmatic. Now as far as within clinical studies, FDA based on the meeting in September, that they had the public meeting seems to be of the opinion that clinical studies will require biopsies. So let's keep an eye out for that, but not from a label perspective that we can see.

Are there any aspects of the label that you think could impact, say, the commercial opportunity or things we should be focused on that maybe [ bookends of ] here's one scenario that would be really great from a label perspective and here's something we hope doesn't have it. Okay, you're probably not going to answer this, but just going to try.

Well, listen, I appreciate the ask. Look, it's that will be a matter of label discussions and reviews. What -- so as I think about the label, you go back to the clinical trial data from MAESTRO-NASH. And we hit on both endpoints of NASH resolution and fibrosis. So efficacy looks really good. Any way you look at the data, it looks strong. So regardless of how the data is presented in the label, the facts are the facts, it works. It seems to work really well. Safety, same thing. The facts of the facts from the study, and I think we're very encouraged by the safety that we've seen in the trials. So to me, those are -- efficacy and safety are really the 2 key areas. And so I'd say, very optimistic but that's a matter of review what the label ultimately looks like. And when we're sitting back here after -- some time after March of next year, be able to go into all the detail about the label and what it means and doesn't mean.

Great. Looking forward to it. You have a study in F4 ongoing. Maybe tell us a little bit about that study and how that's going?

Yes. Look, so it's a study that's enrolling. It's based upon the NAFLD-1 study where we had a cohort of about 180 patients. Well compensated patients with cirrhosis. And we're very encouraged by those results. We've read them out at a couple of meetings previously. It wasn't a placebo-controlled study. So we wanted to go on and do MAESTRO-NASH outcomes, which is the cirrhosis study. It's event-based, so depending on how quickly patients progress, that will lead to the ultimate readout. It's enrolling now. I think the upside of that trial is it would extend our population into this kind of F4 well-compensated cirrhotic patient, and support full approval of the Subpart H approval with MAESTRO-NASH. So we've got that study and then we have the 54-month ongoing MAESTRO-NASH study that will also support full approval. So we think that -- and that's what I'm saying, I think it's a really, really great comprehensive development program that looks at a good range of patients. Now these patients, again, they're the more in-need significant NASH and then you move into that cirrhotic patient, which is essentially, it's just -- it's a different population that, I would say, essentially kind of doubles the size of the number of patients that you have potential to treat. So we'll continue to enroll. It's event-driven, and we'll be able to report back on it when complete.

Any comments on how we should think about timing?

No. I mean, event-driven. It's kind of hard to tell. You're a couple of years at least as you're looking at.

Between that outcome study and the biopsy-based, which do you think come first?

Look, I would tend to think that it is the outcomes, the cirrhotic study that we talked about. But that's where we have the two. So we were in this kind of rare position of having 2 trials that can be racing against each other. Again, we can't affect the biology in the sense that when you have events you're going to have events. The other trial we know is 54 months, so a little bit of a wait there. But again, what -- I have to say, again, kind of the bar that's set by this development program really, really -- first of all, it answers great questions. And then I think it is going to make it that much harder for next companies to try to match the dataset that we have, again, taking advantage of the first mover advantage when you look at the -- some of these programs that are reading out in Phase II. They got a long way to go. We might be getting full approval by the time they're getting a potential for accelerated approval if that is even available to them.

Absolutely. And in the cirrhotic patients, there is conversation is like, does the biology change from F2, F3 to F4? Or is it a continuum? And how should we think about the likelihood of success? I mean you also do improve a lot of cardiometabolic parameters as well. But like how should we think about the potential to improve fibrosis potentially in this patient population?

Yes. Again, I'd go back to the NAFLD-1 study and what we've read out on this cohort of 180 patients. Again, it didn't have a placebo arm, but we were very encouraged by what we saw from a fibrosis perspective, effect on fibrosis. So that's why we will -- that's why we're doing this study. We don't think it's too late. Decompensated, that's a different group. I mean you are now on a glide path to a very, very bad outcome. But there's still -- the remarkable thing about the liver is it is kind of that one organ, if you will, that can regenerate. And while there's still enough function there, if you can provide a therapy that can help it come back really, that's why we're optimistic. There actually is data from that NAFLD-1 that is encouraging.

Yes, yes. Outside of U.S., how should we think about your potential commercial strategy there?

Yes. So look, I would reiterate, our focus, number one, is approval in the U.S. Number two is launch in the U.S. We are really undergoing kind of real strategic review of ex U.S. All those conversations are confidential at this point. It's something that we will update you on when we have an update. But for me, I've just come from running a global business. One of the biggest markets that we had was China actually for DUPIXENT. I'm very much used to launching products around the world. So with that, have a good sense of who does it well, what you can do as a company, what you can do with partners, et cetera. So what we've just -- with me just arriving, it's a good opportunity just to look with a fresh perspective on what the absolute best strategy is for the product and the company.

Philosophically, the structure of a Sanofi, Regeneron commercial collaboration, would you think that would make sense in the NASH space.

Hope so.

You tell me.

Boy, you're bringing me back to where I was. I mean, look -- look, that was an interesting collaboration and very productive collaboration. I think that there are pros and cons with any partnership, right? One of the things that people don't take into consideration with partnerships is the kind of opportunity cost from a management perspective. When you're spending a lot of time trying to work with a partner. And that's good partnerships, bad partnerships. It's just -- there's a lot of time. That's time not spend on kind of your primary objectives. So I think that when you do consider partnership, and this is a general, this is not resmetirom question, this isn't a Madrigal question. This is just in general. You've got to be very certain about what your capabilities are, what the partner brings to the table, who that partner is, how you're going to work together in the future? And spelling out in like complete certainty upfront, who's going to do what, when and how so that you avoid any conflict later on. So based on my kind of years of partnership, not only in my recent past role, but other partnerships I've had, getting it right and being just really diligent upfront to make sure you do it right is just -- I cannot overemphasize the importance of that. So I'm going to be taking that as we evaluate what is the best thing for us to do as a company.

Understood. We're heading into AASLD this weekend. What should we expect from you guys? And what are the key things that you're looking for, both from your own data sets but also from the industry broadly as you head into the meeting?

Yes. It's an exciting meeting. This is my first AASLD. So I'm kind of just excited to see what's the -- how's the meeting look? What's it all about? I was out at ACG in Vancouver a few weeks ago now. And this is really a meeting where our presence is going to be felt. I had a look at all of our plans. It's going to be felt not only from a data perspective. I told you, I think probably the most exciting thing is this NIT data that we're going to be showing that I think is going to be instrumental to the community understanding, and there'll be some efficacy data that we'll talk about there as well to the use of AI and just other readouts that we've had. It's going to be our meeting. That's really it. It's a little bit of a Madrigal launch, if you will. And I say that because no other company has the sheer volume of data, no other company has, I think, a product as meaningful as imminent as us. And we're personally, myself as well, engaging with a ton of communities. So hearing firsthand, that's going to drive a lot of how we think about the final 4 months, 5 months prelaunch, right? I mean you have all the boxes that you check as you're leading up to this point. This is now where those subtle details get decided. And having feedback from the community at this point is really important because it can lean you a little bit this way, a little bit that way. And one of the things that I want to establish is as a company, we are going to listen to the community, partner with the community to really be -- make sure that those partnership implies on the same side of the table, looking ahead towards the future to how you're going to solve this problem for so many patients. So this is an opportunity of a leadership opportunity for us. We have symposia that will take place, et cetera. But we will, I think, demonstrate what's to come, which is leadership in the NASH space for many years.

That's very exciting. Maybe just to close out, what do you think is most underappreciated about Madrigal?

Yes. What's most underappreciated about Madrigal. I think it starts with -- there is this lack of being able to see the opportunity in NASH by, I think -- I still think with the investment community because there's been a series of so many disappointments. And sooner or later, you say, gee, you have to prove to me before I really believe. And I think there's a little bit of Madrigal. It's a small company. How is it that this is -- this small company managed to crack the nut, so to speak. But somebody has to. And a lot of times, it's not just great science, it's perseverance. And the thing that I'm really impressed with this team has stuck with this program over a lot of years, and we are right on the edge now. And I think that, again, it's a little bit of a -- could they really do it? Well, look at the data. The answer is yes. Is there going to be a market? They've attracted somebody who has built big brands in wide open markets or in competitive markets, and we're assembling the team that has done that. So I think it's underappreciated how far we've come and how we've positioned ourselves now to start putting a team in place that isn't treating us like we are a small company. The way I'm approaching this is that there's nothing that I would do differently than if I was launching it from the Sanofi, Genzyme business unit. And so I think that's what's underappreciated at the moment. But we are going to be able to organize ourselves, resource ourselves, especially with the recent $500 million raise that we did, we're ready -- we're going to be ready to go. Now it's not going to be easy just because building any market is never easy. It takes time. You've got to wire the system, you've got to train the physicians. You've got to work with the payers, you've got to have fulfillment all put in place. That's something that I've done. That's something that you can do. So we're going to be ready to go. And we don't have a lot of time, but it's fun and we're attracting great people that want to get onboard this, I think, really wonderful journey that we're on, but the new chapter is going to be turned.

What do you think is the biggest challenge commercially?

Biggest challenge commercially. Look, I think that it is just time, right? Biggest challenge is March 14 is around the corner. I've just -- I literally just arrived 7 weeks ago. So it's just accelerating all of our planning to make sure that we are completely, completely ready. Now the good news is, as I say, we're not entering a competitive market, but I want the teams to be 100% ready to go, and we still have a lot of build to do. We're not -- I'm not suggesting we're behind, but you're building for a game that doesn't even exist yet, which is the treatment of NASH. So that just adds a few more complexities to say, okay, what is the expectation? How do we approach this? How do we approach that? That's the fun stuff. This is the stuff that gets you up every day. And so I'm fully confident we're going to be there. But you always want to have a little bit more time, but a deadline is the best way to get teams focused and prepped and ready to go. And I feel like we have that.

Great. Well, thank you so much for the time. Very much looking forward to hopefully successful drug launch and approval. And thanks for joining us. And thanks for everyone in the room, and I'm sure we will all talk soon.

Great. Thank you very much for having me.

Thank you.