Good afternoon, everyone. Thanks for joining us here today. I'm Richard Maylund. I'm an Associate on the Healthcare Investment Banking Team. It's my pleasure to introduce Madrigal Pharmaceuticals today. We're excited to be here with CEO Bill Sibold. With that, Bill, I'll turn it over to you.
Thanks, Richard. It's a, first of all, a real pleasure to be here. I'd like to thank JP Morgan for having us. This is my first JP Morgan as the CEO of Madrigal, and it's an exciting time for us as we approach a March 14 PDUFA date. A very rare thing in the industry, and to be able to be potentially the first product to be approved in NASH in the United States ever. It's a exciting time for us here. Forward-looking statements. I thought I would start here, to really talk a little bit about the problem that we're trying to solve. You know, NASH is a very, I would say, poorly recognized disease, the severity of it. People don't understand the impact that it has on a patient's life.
And this is, this is Terri, who's become a real patient leader in the NASH community. And unfortunately, the story of Terri is not so different from a lot of people that have NASH. You know, she was told, "You have fatty liver, but don't worry about it," and that's far too often what we hear. Now, despite being told that, she had Fibrosis that was continuing to accumulate over time. She went in and she had gallstones removed, at which time they also detected that she had NASH Cirrhosis. So she was already well down the path of a bad outcome of a disease. She developed ascites, which I don't know if anyone, everyone knows what that is, but that is essentially where fluid overflows into the abdomen from the liver.
She gained 30 pounds in one week and had to have that constantly drained off. Pretty serious. Hepatic encephalopathy, confusion, very difficult for a patient, big impact, and then ultimately had liver cancer. Had a treatment for liver cancer, but ultimately had a liver transplant and is hasn't had the best experience post-transplant. So really, a tragic story. And when you talk to hepatologists, gastroenterologists, too often they have the Terri's on the top of their mind, and they experience this on a frequent basis. Now, Terri, despite all of this, is probably the most positive person you could ever meet, and she was actually inspired a video that we did at numberoneliverfan.com, which was really the inspiration, as I said, was taken from her.
So that's just to level set, because I think it really is important to know what it is that we're trying to talk about here. Oftentimes, we jump right into here's clinical data without a face on it, et c., but this is really somebody. This is what the NASH world looks like. So what's the opportunity? And why is it that I'm here? And it's really, I'm here because of the great opportunity. The opportunity is to build the leading biopharmaceutical company in NASH. I believe that's possible, and the reason why is the following, and I'm gonna go into this in the presentation. First of all, it's a high unmet need disease. You can see that from the previous slide when we were talking about Terri. It's a high unmet disease, and there is no treatment for that disease.
Treatment today consists of go home and modify your lifestyle, lose some weight. You need a great product, or you need a product that is effective, that's been well-studied, that has tremendous evidence to support the use. We have that with Resmetirom, and we'll go into those details a little bit later. Another thing that is somewhat under appreciated in the industry is being first to market. First to market, there are no other therapies. When you have a good therapy and a high unmet disease, is very important. These fundamentals allow us to then do what it is we're going to do, which is an effective specialty launch, and we'll talk a little bit more about that.
One of the requisites of a great launch is having a great team, and that's something that we're well on the way to building as well. I talked about the seriousness of the disease, and a little bit before we review the launch plan, let me just focus in on a couple of things on this slide. It's not only a high burden for patients, but it's a high burden for the system as well, and I'll get into that as well. But with NASH comes an increased risk of Cirrhosis, Liver Failure, Liver Cancer, and Premature Mortality. When you look at the right panel here, NASH patients with significant Fibrosis had a 10x-17 x higher risk of liver-related mortality than those patients with no Fibrosis.
So you can see these, F2 and F3s, and on the bottom, you see that about 22% or one in five patients that are an F3 will progress to Cirrhosis within two years. Now, when you're at this F2 and F3, you've really started on a pathway, which isn't a great one. It means that, you know, your risk level goes up and that it's very difficult to stop that cascade that's occurring. So when you're looking at what is the treatment goal, you really want to be able to stop that negative outcome. And where we're gonna be focusing is in that high unmet need, high-risk patient population. You know, there's been a lot of questions about what's the epi of NASH, and, let me walk you through this. There's about 1.5 million diagnosed NASH patients in the country.
Now, when you look at NASH with significant Fibrosis, which is significant Fibrosis consistent with F2 and F3, that gets you to about 525,000 patients. Now, the next cut that you take is for patients that are being seen by the target specialists that we will be calling on, and that brings you down to 315,000 patients, and you can see the relative break between F2 and F3 there. So it is a sizable population that has a tremendous unmet need, that are in specialist offices that are approachable by Madrigal. So what is it that you're going to want in a therapy for patients like this? And, you know, this is where Resmetirom comes in.
We really see ourselves as becoming the first foundational therapy for NASH with significant Fibrosis. I emphasize foundational in many ways because not only because it's first, but we really believe that's the one that, patients are gonna start with. We believe it could be the one that, patients, you would end up ultimately, wanting to combine with, et cetera. Now, the product profile is very compelling. A liver-directed oral therapy, it's in the pathway of THR beta. This is something which is really, really important to the role of fat metabolism in the liver. Having something which is directed versus an indirect effect on the liver is, again, one of the key attributes that we have of Resmetirom. Efficacy, you need efficacy, and you need safety.
From an efficacy perspective, we're not only resolving NASH but also improving Fibrosis. And I'll show a slide in a moment from some of our clinical data, which is quite important. And we have a favorable emerging safety and tolerability profile, which again, is important when you've got a lot of patients that are potentially candidates for this product, that are gonna be on the product, we think, for a long time as well. Now, the efficacy is one piece of it and the profile of the drug. I think it's in today's day and age, important that you think about your evidence to support value. And we have an extremely, I would say, robust evidence package in that sense.
In fact, for all my years in the industry, I think that this is some of the best HEOR work that I've seen. You know, this is a company that, based upon the great Clinical Data, went ahead and generated and tried to understand the problem that society faces with this disease, et cetera, and the cost to patients and society, and generated really great work. As a result, some of the third-party endorsement here by ICER from a cost-effectiveness perspective put it in the range of $39,000-$50,000 per year. I put that out there because I think it's important that when you are looking at any medication in today's day and age, you have a good sense for what is the value that it brings to society.
So the next question is, is where are we gonna play? I think I gave you that already saying that it's gonna be in this F2, F3, but this is just showing kind of the treatment, or I should say, the disease spectrum, going from no or mild Fibrosis all the way to Cirrhosis. Now, for the no to mild Cirrhosis, pardon me, no to mild Fibrosis, F0, F1, we think this is managed by Cardiometabolic Risk. And how do you decrease that? Our focus is gonna be in this, as again, significant Fibrosis group, and with the treatment goal of being halting or improving Fibrosis and resolving NASH. As I said, it's that progression of Fibrosis which really, really leads to these bad outcomes. Now, as a company, you know, we've...
Our first indication is going to be in this space. However, we are also conducting a trial that's looking more at the well-compensated patient with Cirrhosis. And that opens up another significant portion of patients that are potential for Resmetirom. And that's our outcomes trial that I will talk about in a moment. But there's a very defined targeted population that we will start with, and our clinical development program will allow us, if successful, to move to an even more severe population. So maybe a little bit about the development program, and I think a lot of our confidence in the potential future for Resmetirom lies in, I think, just an outstanding development program that was put together.
You know, when you join a company, and you know, a small company, you wonder, have they done the trials right? Has it been comprehensive? And looking at this development program and really getting to understand it now, it is a really, really outstanding, comprehensive. In fact, it's the most advanced and comprehensive clinical development program in NASH. We have MAESTRO-NASH, which is, what the approval will initially be on with the 52-week, biopsy, study. That will move on to a 54-month outcome study. That's ongoing. We had a MAESTRO-NAFLD-1, which was a large safety study, 1,200 patients. And then we have, also the ongoing MAESTRO-NASH OUTCOMES study, which is in the compensated, well-compensated Cirrhosis patients. So again, really, really well-designed.
It set the bar for everyone else, and when you take a look at the other development programs that are in progress or coming, they're generally based off of the great work that was done by the team here. So maybe on this first slide, I think really important, here are some of the results from our Phase III MAESTRO-NASH trial. You know, the results are really unprecedented. We hit on both of the primary endpoints, and just to remind you, that's the first program ever in the development of NASH to do so. In order to get FDA approval, generally, you had to hit on one. We hit on both. You look at the key secondary endpoint that we hit on LDL cholesterol, quite a profound effect there, too.
So very, very strong data, and this is, as I said, the primary endpoint. Now, you know, let's take a look a little bit more at the depth of response data with patients with biopsies at 52 weeks. So the previous slide was ITT. This is looking at 52 weeks if you've had both biopsies. And what you can see is that, when you look at the NASH resolution or Fibrosis improvement, you had 50% of patients showed either NASH resolution or Fibrosis improvement. And another sign of the depth, when you add no progression of Fibrosis to that, it gets you to 90% of patients. So overall, a very deep and broad response by patients. And it's...
I know it's a question that we've had, in the past, and this begins to explore, just how, profound an effect, there is for patients. Now, this last slide I'll show, on efficacy, this was showing how Resmetirom improved key non-invasive measures of treatment response. So Liver Reduction, Liver Fat Reduction, I'm sorry, is measured by MRI-PDFF, which is considered extremely, extremely sensitive, was highly associated with both NASH resolution and Fibrosis improvement in Resmetirom-treated patients, and you can see in the panel on the right how that's demonstrated. Now, one of the interesting observations here was that the PDFF reduction in placebo patients was associated with an improvement in NASH, but not Fibrosis. So there's a lot of question about what is the value of direct, liver direct therapy versus indirect.
You know, what we believe is that the liver-directed nature of Resmetirom has and allows for that effect on Fibrosis. Now, outside of these measures, compared to placebo, there were demonstrated improvements in liver enzymes, liver fat, liver stiffness, ELF, and as I said before, there was an impact on cholesterol as well. So, I mean, you know, really, when you look across the various metrics and the impact that Resmetirom is having, it's actually quite profound across all these measures. Now, safety is obviously very important, especially when you're talking about a population like this that is on other medications as well, a population that we think is going to be on this drug for more of a chronic nature.
You can see that, across the 80 milligram, 100 milligram, and placebo, the emerging profile is very, very favorable from a safety and a tolerability perspective. Looking at study discontinuations in the 100 milligram arm, they were increased over placebo, and this was during the first 12 weeks. By the end of 52 weeks, actually, placebo discontinuations were higher than the drug treatment arm. The type of AE that was seen mostly were these GI related, so it's reported as diarrhea, but that could be loose stools, and that's the way you categorize it, et cetera. So generally, this was something that was transient in the first two to three weeks and then resolved over time.
So overall, a very nice emerging safety profile and tolerability, and there was no DILI events. So where do we go from here? I think that what you see is we got a great potential with high unmet need disease, a product that works, and a company that I think is extremely well suited to take advantage of this opportunity. Now, I'm gonna just say just a little bit here before getting into what we're doing for launch, just what happened to us in 2023, achieving Breakthrough Therapy and Priority Review, filing a product, which is no minor feat. But we have it under review at the FDA now. I think most companies would be thrilled about that. We certainly are.
And now we're moving into the exciting piece, which is, launch of Resmetirom with our PDUFA, PDUFA date, pardon me, of March 14. And then in the future, you know, we're looking at full approval, plus the compensated Cirrhosis label. So let me just tell you a little bit about 2024 and what we are gonna be working on, in our efforts leading up to launch and the priorities of launch. So, kind of, kind of three key activities: we build the organization, we develop the market, and we execute a specialty launch. You know, first of all, on building the organization, we are, fully green light, hiring sales teams. We are ready to deploy. We are planning for success on March 14, and we will be ready to go.
Now, you know, it's no small feat when you're scaling up a company like this, but we think that we've brought an experienced team in, and the team that we're bringing in, we're not bringing them in for launch, and it's a couple quarters of, you know, trying to do great work. We're hiring people for peak. What does that mean? There's a difference. I think you're launching for essentially a two to three year period. But you need people that have seen what it's like to scale an asset, and that's the type of person that we're bringing in. You know, I have personal experience. I was working in the atopic dermatitis world with Dupixent. I certainly understand what scale looks like, and the people that we're bringing in do as well.
Develop the market, and I do wanna emphasize here that as the first, which is a great benefit, there's also a big responsibility because you're setting the standard for everyone else who follows, and you have to take the time to ensure that there's a pathway for patients not only to get through a physician's office, get a prescription, have the script filled. And that takes work with insurers, takes work with specialty pharmacy, with the company, with the patient, with the practice. We have to wire the system over the next 12 months of post-approval. That takes some time. It's not a bad thing, it's a good thing, but it does take time, and that allows you to kinda open the pipe, so to speak, for patients to get through more efficiently and effectively.
That's why we're hiring the team that has the experience doing that, so that we can very rapidly and effectively do that. I think that there's a lot of work to be done, but it is great work, and I feel we have a great team to do so. Finally, I'll just comment on the execution of a specialty launch. You know, I think that there's been a lot of... or some questions about where is it that you are going to? How are you gonna target? Who are you gonna launch to? And I think, as you can see through this, we're only interested in the patients most in need, these NASH with significant Fibrosis. We aren't trying to spread out to earlier patients.
We think that, A, it's important for us to focus on the patients that are in the most need. I don't think you benefit patients or yourself by trying to go to places where you haven't studied the drug and where you see there, there's a benefit. So it's gonna be targeted on hepatologists and gastroenterologists, and to the who have these 315,000 patients that are currently diagnosed in their practice. So it's a I think really a tremendous opportunity. If you, if you ask me, I don't think there's a better opportunity in the entire industry today. You know, I believe that because, you know, I'll start, and I say this in most of my presentations, that I think this is the greatest industry in the world.
It's the greatest industry in the world because if we do our jobs right, we can help patients that have really bad diseases. We can save lives, we can transform lives, and it's not only the patients, it's everyone who's associated with that patient. This is a huge unmet need. There are patients that are, you know, waiting their whole life for a drug like this. It's a, it's a real pleasure for us to get to launch in this space, and I think it's something that we can be incredibly successful at. And I think, as we wait for March 14, which is, you know, 45 business days away, we are gonna be ready to go. So, with that, maybe I will open it up for Q&A.
Bill, thanks so much. Really great, really informative presentation. We're super excited to have you here today. I guess the first question from me, you've been in your current role a few months now. Can you talk us through the decision to join Madrigal and what led to that?
Yeah. I mean, look, it was. I was in a, I think, a really great role, previously, at Sanofi Genzyme. I think, you know, what I liked about that was there was an ability to help a lot of patients and a lot of different diseases around the world. And so for me to be interested, it was having to have that same criteria to be able to say: How can you help a lot of people? And that's why, you know, this, with it being such a high unmet need and no therapy, that was very attractive. Now, what also was attractive is, I think the reality is, in this industry, great assets determine success of companies, and there aren't so many great assets in the industry.
I was in a position previously where I could survey the world to see, you know, what was really interesting, both internally and externally, and there aren't so many. I think you can build a company around a great asset. I think, you know, for me, observation over the last years has been that if you have a great asset, I'd much rather go back and build a pipeline and other capabilities than wait for, a number of bets on science to, pan out over time. Now, in this case, I'm the benefactor, of, all the hard work that, Becky and her team have done over the years. But there is this potential now that as we launch, we can build that truly leading NASH Company and begin to just extend that leadership.
Great. Thanks so much. Speaking of great assets, can you give us any color on how the FDA interactions are going, and the NDA review progress?
Yeah. So look, I'm not gonna give any play-by-play with the FDA, but maybe a couple of data points. As you heard me mention in the presentation, we're, I think it is 45 business days to PDUFA. FDA needs to give 55 days advance warning for an advisory committee. So we've kind of passed that threshold. So that's encouraging. You know, and as I also said earlier, our plan is around success on March 14. So all of our hiring and scale-up has that date in mind. So, you know, without providing any further details about it, I think that kind of gives a sense for, you know, that things are proceeding towards March 14.
If there's any changes material, we would let people know immediately.
As a follow-up to that, what are you expecting to see on the label? I guess, as part of that question, will biopsy be required to diagnose patients? Also, will patients on the label be limited to the F2, F3, which you studied in phase lll?
Now, look, great question. We don't anticipate that biopsy will be a part of the label. Now, or a part of the indication or the label. Now, the question of, you know, what does that indication statement say? And again, not sure yet, because that's, you know, something that will be clear at the end of the review. Now, I guess you can look at one of a couple of ends of the spectrum. If it's a broader label that includes more than the F2, F3, or if it's something which is narrower, which is more related to F2, F3. Our view is it will not change at all who we target.
So if it's a broad label, we will still only be looking at those NASH patients with significant Fibrosis since that's what we studied, and if it's already narrowed to that, that's fine, too. You know, when we have the data available from our MAESTRO-NASH outcome study in that well-compensated patient with Cirrhosis, and if it shows a positive effect, then obviously the indication... Well, we would update the indication, I guess, at that point, and that would be in our list of targets. But, you know, it's a little early to tell. And one of the challenges, and I know anyone who is, you know, following us, one of the challenges is predicting what does that label look like?
And the reason why it's a bit of a challenge is, since this is the first product to be approved, you don't have anything really to compare to. A lot of times when you're the 4th, 5th in some of these diseases, the 12th, 20th, 25th product in the space, you have a pretty good sense what the label could look like, what the pluses and minuses. Here, you know, the agency's making a decision not only about the label for Resmetirom, but they're thinking ahead as well and thinking about NASH in general. So, I would say, you know, as soon as we have the final label, we'll certainly share it with everyone.
Thanks. Super helpful. Moving on to a question about market sizing and segmentation. Building on what you just presented on the patient epi data, you referred to targeting 315,000 NASH patients with Resmetirom. I think historically, we've heard larger epi numbers of NASH patients. Can you just help us understand the difference?
Yeah, I mean, I think, I think there's a couple things. When you try to apply epi numbers to a population, it certainly. You know, when you've got a country with 350-400 million people, the numbers, the numbers get pretty big. But what we did is wanted to be more rigorous in that we wanted to look and see who already had a coding for NASH. Now, I think that, you know, that's a great starting point. That's the 1.5 million, and since we're only focusing on that NASH with significant Fibrosis, and that takes you down to the 525.
But from our perspective, since we aren't gonna be calling on primary care physicians, et cetera, if the patient isn't being treated by a specialist who understands the disease and the product, then they won't be getting the drug because those are, that's who will be prescribing. So I think that's how we get down to the 315, which is by just being, you know. A huge denominator that doesn't have any real ability to, at least currently be diagnosed, et c. to me, that isn't what should be included in the denominator. This is really the approachable population, we think. Now, over time, things will change. There might be better diagnosis, et cetera. But for right now, that's where we're starting.
And again, you know, this, we very much believe is a specialty launch. The reason we believe it's a specialty launch is because it is a very severe disease. It's a disease that specialists should be treating, and it's a disease that, you know, when I say small enough from a prescriber perspective, that it allows us as a company, I think, to very effectively approach the launch rather than if it was a primary care launch.
Great. Speaking of approaching the launch, so could you just talk a little bit more about the status of your commercial build and how that's going?
Yeah. So, you know, this is the fun part, right? You know, this is, not that the development and things aren't, but for me, who's spent, a lot of years launching products, the build is fun. It's great. And so we have, all of our, kind of leadership, field leadership, and that includes, in on the medical affairs side... plus the sales and commercial side, all of the leadership's in place, and now what we are doing as the final step, it's adding really those sales reps, and other support staff that will support us in the launch. So that is just a scale-up issue. You know, we've had. We're really thrilled with the candidates that we've had, the reps that we've already hired, and, just the general profiles of the employees.
For the reps, you know, for the most part, we're looking at people that have a hepatology or gastroenterology experience. That's just important because they're familiar with how those practices work. They're more familiar, in some cases, if they've been in the Hepatology space with the disease. So that's getting in place. We then start to transition to as soon as we launch the product, we will have, you know, real conversations with payers about obviously, pricing and reimbursement. So that's kind of a to-come, but all of our teams are ready, training, executing.
Thanks. As a follow-up to your response about the market sizing, so how will patients be diagnosed in clinical practice? And I guess, how often, how frequently are patients biopsied to confirm diagnosis?
Yeah. So it's, it's our understanding that about 2%-3% of patients are, have a biopsy. Now, one of the challenges with a biopsy, there's a few. One is it's not definitive. It's not as though, you know, you're, looking for like, you know, basal cell carcinoma or something, right? It is. It's... You only get a thin, thin piece of the liver, and that may not be very representative of the condition of the total liver. So it doesn't happen so often now, and in fact, I would say when you talk to the experts, they're moving away from biopsy. The reason they're moving away from biopsy is because there are other NITs, that are non-invasive, obviously, by definition, that allow them to make the diagnosis with, in their view, certainty.
So typically, it is a diagnosis by using blood tests and by using some kind of imaging. Probably the standard today is there's a blood test, which is just a number of regularly measured items called FIB-4, and FibroScan is probably FIB-4 and FibroScan are probably the two things that are used more universally. Now, there's other imaging technologies, MRI, MRE, et cetera, and there's other blood work that can be done, such as ELF. I think that where we're at right now is we're at really the beginning. There isn't a therapy yet for people to be testing more frequently and really paying attention to kind of these results, because what do you do with them?
You tell somebody, "You're just getting worse," or, "This is what the condition of your disease is." The way I think it will evolve is if you look at where we are at launch versus 3 years and 5 years from now, I think that there will be a much better defined use of how you sequence the NITs, how you mix them together, or if there's anything new that emerges.
You know, again, this is the beginning of the treatment of a disease, and if you look at other specialty diseases, it can take decades for the progression to, A, penetrate into all the patients that are in need. How do you diagnose? How do you treat, et cetera? So, you know, I, I can't emphasize enough how early we are in this treatment. This is the veritable graveyard of drug development, and we are the first to, as you know, we are expecting on March fourteenth, to make it through that minefield, if you will.
Thanks. That's super helpful. I guess a question that everyone has gotten this year: What's your perspective on the potential impact of GLP-1s on Resmetirom use?
Yeah, that's a question I get a few times a day. You know, since I've been at the meeting, I think it's something which is has come up a lot. I mean, you know, if you're... If the airlines are getting a question, I guess it's fair that I get a question as well. So look, the GLP-1s, you know, here's the one big difference. March 14, PDUFA date, and we have clinical data that supports the impact on reversal of Fibrosis and halting Fibrosis. To date, that hasn't happened with the GLP-1. So we will be watching to see what happens this year as the cards are turned over.
But, you know, going back to the one slide that I showed with the efficacy, looking at PDFF as well, where the observation from our trial was that for the placebo patients that had NASH resolution, there wasn't that impact on Fibrosis. Now, what does that say? Does that translate a little bit more into having to be a liver-directed therapy or something unique about our mechanism of action? You know, we think so, but, you know, let's see what happens. Now, I think that you saw on my slide as well, where we're looking at kind of that early-stage NASH. Before there's Fibrosis or significant Fibrosis, you know, maybe that's a reasonable place for a GLP-1 to play to try to prevent the progress to Fibrosis.
I think, you know, also referring back to the presentation, when you've got 22% of patients that are F3, that in two years are going to decline to being patients with Cirrhosis, that doesn't leave you a lot of time to try to have an impact on the Liver. And the one thing that we do know in the GLP-1 trials is you have your dose titration, which takes time, and then time after that for an impact to take place on NASH. So do you really have the time to wait for the weight loss, et cetera, to have an impact and ultimately any impact on NASH? So, you know, from our perspective, you know, we think it's important that any patient-...
Do whatever lifestyle modifications, et cetera, take what they need to, to help them if they are obese. You know, we're certainly supportive of that, but we do believe in the population that we are prioritizing, which is these NASH with significant Fibrosis, that they are in need of a liver-directed therapy quickly. They don't wanna wait for the indirect effect of another medication. So let's see what happens, but, you know, again, remind you, we're first by many years. We have data which is unprecedented, hitting on NASH resolution and reversal of Fibrosis. And our profile, we are a oral, once-a-day, effective in trials, favorable safety profile and tolerability profile. That is a profile which usually takes sometimes decades in a new disease to ever be available, because usually it starts out pretty rough, the first approvals.
We happen to be launching with a profile that is... I would never use the word, ideal, but it's certainly compelling.
Thanks. Is it too early, or can you share any thoughts on potential pricing for Resmetirom?
Well, look, I mean, I think that, as you think about this and what I've said to others, is this is a high unmet need, and the product provides tremendous value. You've seen that in the pharmacoeconomic work that's been done. We're saying this is a specialty launch. With that will be specialty pricing, and we're not certainly in a position to announce pricing yet. We haven't made the decision on pricing yet, but you can also look towards, the work that was done by a third party, ICER, that put us in that, $39,000-$51,000 from a cost effectiveness perspective. So we'll take that all into consideration. Just as a, principle and how I think about pricing, I think you should price, for the value of the medication.
That's something that as we get close, or as we get approval, I should say, we'll make an announcement on what the price is then.
Bill, we have about a minute left, so are there any key messages you want to leave investors with today?
Sure. Well, thank you. So first of all, thank you for being here. Thank you for listening to the story. As I said, I do think this is the single best opportunity in the entire industry because it's all the best parts of the industry. It is a high unmet need. It's innovation that helps a lot of patients, and I think it doesn't get any better than that. Now, I believe that what my role is is to build a great company here, and I think that we have the ingredients to do so. As I said, high unmet need, a product that is fulfilling that unmet need, and the kicker is, if you will, we're first by a long shot.
To have the time to build and set the standard for what's expected in a disease like this is something that doesn't happen too often. I can just say, even personally, from a career perspective, I can't think of a better opportunity to do the good of the industry through Madrigal.
Great. Thanks so much, Bill. And thank you, everyone, for being here today.