All right, we can get started. 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 us here. It's a real pleasure to spend some time. You know, look, I'm seven weeks into the new job, and I have to say, you know, I've been waiting for that moment where I say, "You know, 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.
You've got a company that, against all odds, has brought forth an incredibly robust, a 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, you know, that's as good as it gets in this industry. You know, 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 sets you forward. I'd much rather build a company around a great asset than to just, you know, be dabbling over years with a pipeline and hope that something hits.
So, you know, the chance to build the one in a thousand that makes it is really what drew me here.
Mm-hmm. Exciting. Maybe tell us a bit about your experience at Sanofi and particularly, you know, the experience that you can leverage in launching resmetirom and MASH.
Yeah. I had a long stay at Sanofi, and, you know, it goes back to 2011, and I came on board to build a multiple sclerosis franchise. This was just after the purchase of Genzyme, so I was always in the Genzyme business unit. And, you know, we went from about $1.5 billion in sales to $16.5 billion last year, 48 consecutive quarters of double-digit growth, 11 launches. And, you know, 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, you know, I look at a lot of the parallels, and, you know, it's.
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 and say: How would you approach this launch in MASH? So for me, it's more of the experience of, you know, what to ask, how to think about what are 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, you know, it starts with having the right, first of all, you know, right product. You need a great product, and then you need the right, people to put in place.
And so we're in this stage now where we're building a team that is going to be capable of launching, you know, a truly, truly great asset.
Mm-hmm. Uh-huh, absolutely. And look, there's a lot of controversy over the size of the MASH market opportunity. How are you thinking about it? And you know, you mentioned your excitement about the market opportunity and joining Madrigal. And yeah, I mean, what are people getting wrong? What gives you confidence in the size?
Well, you know, 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, you know, it starts to get that reputation of kind of that sepsis market or scleroderma, et cetera, where there's been, you know, just this track record of failure. So I think, you know, people absolutely understand the unmet need. You know, when we talk to physicians about the unmet need, they don't have anything for the patients. You know, 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's been there, it's very hard to visualize that market developing.
Until there's a product that's approved and grows and shows there's a market, others are gonna 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. 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. You know, just thinking, you know, the potential size of the market, you know, we're taking a specialty approach to this. So we're gonna be focused on hepatologists and gastroenterologists, where there's patients that have MASH with significant fibrosis, which is an F2, F3 type of patient.
You know, we know in talking to the clinicians that they have practices full of these people. Now, just to give you some ideas of the numbers, there's, you know, about 1.5 million diagnosed MASH patients in the United States. And about 35%-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 gonna 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's a it is a certainly a high unmet need market, nothing there.
As the first therapy, I think, you know, we really get to set the tone.
Mm-hmm. And I guess, where do you see resmetirom fitting, particularly across the different patient segments, physician populations, and first treatment in MASH, but there are GLP-1s, and so how do you see resmetirom fitting in that context?
Yeah, look, so I mean, we're gonna be very specific for these most in-need patients, these F2s, F3s that have significant fibrosis. That's where we did the clinical trials, right? And, you know, that's where the data supports the use of the product. You know, we don't think just everyone should get it. We're not looking at that earlier, you know, F1, F0 type of patient. It's just, you know, this is patients that you have significant fibrosis, and you're on that pathway to then moving to F4, you know, well-compensated cirrhosis, and then decompensated, and that is, you know, your next stop is transplant, bad cardiovascular outcome, liver cancer. Not a good path to be on.
So we really wanna 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. I think that that's a, 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, once we launch the product. Now, 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. You know, 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.
You know, there's been, I would say, a lot of discussion, obviously, about GLP-1s in the broader context of not only weight loss, but, you know, downstream effects to other industries, even. You know, a few things I'd say, you know, we're liver-directed. We, resmetirom works on the liver. GLP-1, the hope is, you know, you take away weight, and therefore, you ultimately have an effect on the liver. I think there's always gonna be a need when, you know, you have a patient that's already in this kinda 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-1s, you know, you do have a dosing titration schedule 20 weeks+ . 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, you know, that's, I think, gonna 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 gonna be focused on, you know, these patients that are already there at the clinicians. And just, you know, some of the numbers as well, there's about 110 million obese Americans. And if you look at any of the potential forecasts of the GLP-1 class, if you call it $100 billion, that could represent 10%-20% penetration.
So you've got 80 million-90 million obese people that still have all the potential risk factors that could ultimately lead to things like type 2 diabetes, lead to MASH. So I look at it that this is a big enough market. There's enough people coming in that are gonna end up with MASH in that F2, F3 significant fibrosis designation, that we're, as the first mover, really in a great place to build a market and take advantage of that.
Mm-hmm. Absolutely. And, maybe just, I know you joined seven weeks ago?
Yeah.
So I know launch preparations are probably more of a, you know, planning stages now. But I guess as you approach your launch preparation, what are your top priorities? And you know, what are you most focused on in terms of across education, building a sales force, and, you know, planning that out?
Yeah, I mean, look, you know, pre-launch, first thing is get approved. That is really the objective, which I'm, you know, 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, focus on hepatologists and gastroenterologists, focus on patients with significant liver fibrosis, F2, F3. Now we build the team around that. And, you know, we're just taking the steps that you take to, in advance of a, you know, March 14th PDUFA date.
So, you know, 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, you know, that's where I can rely upon the experience of having prepared for, you know, 11 different launches. What's the right sequencing and timing? And so, it starts so with what's the right team to be ready to launch the product.
How are you thinking about diagnosis? I think you mentioned, what, 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. You know, 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 non-invasive 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, you know, 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.
I think that when you look at today, it's gonna be different than post-approval, where people say, "Now I'm gonna 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's only gonna get better and better utilizing the various tools like MRE, MRI-PDFF, ELF test. And where we are today versus three years and five years, I think it's gonna 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's a therapy in that mix? And I think that's what you're gonna see evolve. And again, you know, 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 MASH and work with the community to find that path forward.
Mm-hmm, absolutely. You alluded to this before, but, you know, where do you think physicians are, maybe breaking it down between hepatologists and gastroenterologists, which you said are, you know, gonna be your target prescribers? Where do you think they are in terms of awareness and seeing MASH as a disease that needs, you know, drug intervention.
Yeah.
Versus saying, "Hey, go home and diet and exercise," or, "Hey, here's, you know, a GLP-1?"
Yeah, look, I think there's a very high awareness in the physician community of MASH, 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, you know, 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, you know, nervousness, disbelief, and it's, they don't wanna 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, you know, they just can't put their hands around it. So I think, you know, 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'll be kind of a system well wired to process patients for resmetirom.
Mm-hmm. The patients that are, I guess, diagnosed.
Mm-hmm.
Somewhat and under care right now, what does this look like, you know, after a theoretical launch? I mean, is there a group of, you know, patients, and maybe we can debate the size, that's, say, waiting, you know, and, you know, eagerly.
Yeah.
Wanting something?
I mean, it's a little bit, it's a little bit. This is where you gotta look at the specifics of the disease. This isn't a symptomatic disease where someone's walking around. You know, like, if you have somebody, for instance, most recently, with eosinophilic esophagitis, you can't eat, 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, feeling the effects of the disease until it's too late. And, you know, if you become decompensated cirrhotic, it's miserable, and it's a, it's, it's a really bad outcome. I think there's been a reticence to even tell patients how bad the outcome could be.
You know, 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.
Mm-hmm. How large of a sales force do you think you need?
Well, look, it's a specialty-sized sales force. I'm not getting into the absolute specifics, but, you know, it is something that, as a company our size, we can, I think, target extremely, extremely well, with the physicians that have the, the, we think that, you know, the bulk of the patients that are most in need.
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.
Yeah, we don't expect that a biopsy would be required. You know, I think especially, so if you, if you look at the AASLD starting this week, you know, one of the presentations we have, it looks at the NITs and their how good they are at both kind of diagnosis and watching kind of and monitoring the progress of a patient with MASH. So I think it's just not practical to expose a patient to the risk associated with a liver biopsy. It's you know it's something that, you know, it's not pleasant for the patient. The accuracy is not definitive, it's not great.
The use of NITs, as you know, 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. We're not anticipating that that is gonna 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. Now, I think, you know, as I said, it's gonna take some time for not the development of technology, but how do people feel best about sequencing and blending the use of NITs to have, you know, the most accurate results.
Mm-hmm. Have you had any initial conversations with payers?
Yeah, payer, 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. You know, it's one of those things, until you're confronted with the disease, you know, you don't think about it too much. You, you know, 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, you know, I'd say that they've been constructive, discussions to date. Look, I think the reality is, there's no product that launches that, you know, you don't have, long discussions with payers about, right?
Mm-hmm.
You know, I think it always is better, a couple things: one, that you have an innovative product that works. You have an innovative product that if it shows cost effectiveness, certainly helps you. You know, there was an ICER report that was that came out earlier that I think you know really spoke to the benefit of resmetirom. And there aren't too many products that have the ability, especially pre-launch, to have assembled enough information that you have, you know, such a good report. So, you know, we're gonna. We, I, 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, you know, some, you know, tension associated with it.
Mm-hmm. Anything surprising so far?
Since joining?
Or with the payers.
With the payers?
Yes, maybe that, too.
No, I would say no, nothing surprising. It's just, you know, it. There's nothing surprising. It just takes time, right?
Mm-hmm.
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. You know, the one 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, you know, that is helpful. You know, 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, gonna be extremely, have us looked upon favorably.
Other surprises, you know, I'd say the surprise is that being this far into it, I'm more excited than I was when I started on day one and made the decision. I have absolutely no doubt that this is just a unique, incredible opportunity, and I've just had a great time.
Mm-hmm. Great.
Mm.
Love to hear it. Maybe philosophically, and also perhaps, you know, after presumably 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 that in the label that could affect how you would 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 for thinking about pricing?
Well, I guess a couple things. First of all, from a label perspective, you know, it's too early to make any comments on the label. From a pricing perspective, we will announce price upon approval.
Mm-hmm.
We're still looking at it. You know, again, as I said, this is a specialty launch focused on patients in most need, and I really believe that, you know, a medicine should be priced based on the value that it provides. So, you know, it's hard to find a real comparator to this product, you know, because there isn't really a good comparator to it right now. But, you know, I think I'm, you know, really optimistic that we'll land on kind of the right price, but you'll have to wait until we get to launch.
Mm-hmm. Okay, understood.
You can keep asking, though. Everyone's been asking it, and the same question, the answer is the same. So, just we're not too far away. I mean, March 14th is really just around the corner.
Mm-hmm. How are the regulatory interactions with the FDA going? And any color you can give us on the process of where you are?
Yeah, look, I mean, you know, we announced the priority review. We announced that PDUFA was March 14th, that no Ad Com was necessary at that point. So I would say all I would you know, summarize is that regulatory conversations have been productive. And I don't have any other real details than that.
Mm-hmm.
What I will also say is that we're planning for success. You know, all the launch planning that I'm doing and the building, we're building around the March 14th date. So, you know, as I said, I think it's a highly approvable product. You know, again, you know, I think the one question you may ask is, you know, what about any cycle extensions and so forth? Look, that's an FDA review timing issue more than anything. You know, 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.
You know, kind of your guess is as good as mine, but my approach is to plan on March 14th.
Mm-hmm. Absolutely. I know when the filing was accepted, it was said that the FDA is not planning to have an Ad Com.
Yep.
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.
Yeah. I mean, look, I think the best thing to do is always be prepared, right? You know, you do yourself no favors if you have hope as a strategy. I always believe in prepare. If they change their mind and they want to do that, you know, we'll be ready. If they, you know, don't wanna have one, that's fine, too. It's always good practice for the team.
Mm-hmm. Is it possible you get an Ad Com? 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, you know.
Okay.
Let's see.
I apologize. I'll stop asking now.
No, I mean, look. I don't have the, I really don't have anything else that can provide any.
Mm-hmm.
Yeah, any, any direction.
Mm-hmm. Going back to the conversation about biopsies.
Yes.
A question I get a lot is, will there be a biopsy requirement in the label or something that specifies, you know, something that indicates the diagnosis is done via biopsy?
Yeah. I think that would be highly unlikely. You know, it's just, I don't think FDA typically wants to tell doctors how to diagnose and do their job. So, you know, certainly not expecting it, and as similarly, not expecting that it's a part of reimbursement criteria or any utilization management criteria. But, you know, I, it just, gee, biopsies themselves are certainly not perfect indicators of disease severity. I think what you're gonna find again, is through the use of these NITs, you're gonna be able to get a lot closer to the precision of what's the status of the patient's liver or their MASH, in this case. So I think, you know, that's why I don't think biopsies are gonna be practical or pragmatic.
Now, as far as within clinical studies, you know, 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.
Mm-hmm.
You know, let's you know, keep an eye out for that, but not from a label perspective that we can see.
Mm-hmm. Are there any aspects of the label that you think could impact, say, the commercial opportunity or things we should be focused on that, you know, maybe bookends of, you know, here's one scenario that would be really great from a label perspective, and here's something we hope doesn't happen? Okay, you're probably not gonna answer this, but just gonna try.
Well, it's, y ou know, I appreciate the ask. Look, it's, you know, that will be a matter of label discussion and reviews. You know what? So as I think about the label, you know, you go back to the clinical trial data from MAESTRO-NASH, and we hit on both endpoints of MASH 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. You know, the facts are the facts from the study, and I think, you know, we're very encouraged by the safety that we've seen in the trials.
So, you know, to me, those are, you know, efficacy and safety are really the two key areas. And so, you know, 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, you know, after, sometime after, March of next year, be able to go into, you know, all the detail about the label and, and, and, what it means and doesn't mean.
Great, looking forward to it. You have a study in F4 ongoing.
Mm-hmm.
Maybe tell us a little bit about that study and how that's going?
Yeah, 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. You know, we're very encouraged by those results. We've read them out at a couple of meetings previously. You know, 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, you know, how quickly patients progress, that will lead to the ultimate readout. It's enrolling now. I think, you know, 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, you know, we think that, a nd that's why 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, you know, they're the more in need, you know, significant MASH, and then you move into that cirrhotic patient, which is, you know, essentially, it's just a different population that I would say, you know, essentially kind of doubles the size of the number of patients that you have potential to treat. So, you know, we'll continue to enroll. It's event-driven, and we'll be able to report back on it when complete.
Mm-hmm. Any comments on how we should think about timing?
No, I mean, event-driven, it's kinda hard to tell.
Mm-hmm.
You know, you're a couple of years at least, as you're looking out.
Between that outcome study and the biopsy-based.
Yes.
Which do you think come first?
You know, look, I would tend to think that it is the OUTCOMES, the cirrhotic study that we talked about.
Mm-hmm.
But, you know, that's why we have the two. So we're in this, you know, kind of rare position of having two trials that can be racing against each other. And again, you know, we can't affect the biology in the sense that when you have events, you're gonna have events. The other trial we know is 54 months, so a little bit of a wait there.
Mm-hmm.
But, you know, again, what a, y ou know, I have to say again, the, 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 gonna make it that much harder for next companies to try to match the data set that we have. Again, taking advantage of the first mover advantage. When you look at, you know, some of these programs that are reading out in phase II, you know, they got a long way to go. We might be getting full approval by the time they're getting, you know, potential for accelerated approval.
Mm-hmm.
If that is even available to them.
Mm-hmm. Absolutely.
Yeah.
And in the cirrhotic patients, there's conversation of, 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, you know, cardiometabolic parameters as well, but, like, how should we think about the potential to improve fibrosis potentially in this patient population?
Yeah. 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, you know, that's why we're doing this study. We don't think it's too late. Decompensated, that's a different group.
Mm-hmm.
I mean, you are now on a glide path to a very, very bad outcome. But there's still, y ou know, the remarkable thing about the liver is it is kind of that, that one organ, if you will, that can regenerate. And, you know, while there's still enough function there, if you can, you know, provide a therapy that can help it come back, you know, really, that's, that's, that's why we're, that's why we're optimistic.
Mm-hmm.
You know, there actually is data from that NAFLD-1 that, yeah, is encouraging.
Yeah. Yeah, exciting. Outside of the U.S.
Yeah.
How should we think about your potential commercial strategy there?
Yeah. So look, I would, you know, I'd reiterate, our focus, number one, is approval in the U.S. Number two, is launch in the U.S. You know, we are, you know, 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, when we have an update. But, you know, you know, for me, I've just come from running a global business. You know, one of the, the biggest markets that we had was, you know, China, actually, for DUPIXENT. You know, I'm very much, used to, launching products around the world.
So, with that, have a good sense of, you know, who does it well, what, you know, you can do as a company, what you can do with partners, et cetera. So what we've just, you know, 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.
Mm-hmm. Philosophically, the structure of a Sanofi Regeneron commercial collaboration, you know, would you think that that would make sense in the, in the MASH space?
How so?
You tell me.
Well, boy, now, you know, you're bringing me back to where I was. I mean, look, that was an interesting collaboration and very productive collaboration. You know, I think that there are pros and cons with any partnership, right? You know, 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 spent on kind of your primary objectives.
So, you know, I think that when you do consider partnership, and this is a general, this isn't a 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 gonna work together in the future. And spelling out in, like, complete certainty upfront, who's gonna do what, when, and how, so that you avoid any conflict later on. So, you know, 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, you know, just really diligent upfront to make sure you do it right, is just, I cannot overemphasize the importance of that.
So, you know, I'm gonna be taking that as we evaluate what is the best thing for us to do as a company.
Mm-hmm. Understood. We're heading into AASLD this weekend.
Mm-hmm.
What should we expect from you guys? And, you know, what are the key things that you're looking for, both, you know, from your own data sets, but also, you know, from the industry broadly as we head into the meeting?
Yeah, it's an exciting meeting. This is my first AASLD, so, you know, I'm kind of, you know, just excited to see, you know, what's the how does the meeting look? What's it all about? I was out at ACG in Vancouver, a few weeks ago now, and, you know, this is really a meeting where our presence is going to be felt. I've, you know, had a look at all of our plans. It's gonna 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 gonna be showing that I think is gonna be instrumental to the community understanding.
And, you know, 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 gonna be our meeting. That's really it. It's a little bit of a Madrigal launch, if you will.
Okay.
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, you know, we're personally, myself as well, engaging with a ton of the community. So hearing firsthand, that's gonna drive a lot of how we think about these final, you know, four months, five months pre-launch, right? I mean, you have all the boxes that you check, and as you, 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, you know, lean you a little bit this way, a little bit that way.
You know, one of the things that I want to establish is, as a company, we are gonna listen to the community, partner with the community, to really make sure that, as partnership implies, on the same side of the table, looking ahead towards the future to how do you solve this problem for so many patients. So this is an opportunity of a leadership opportunity for us. You know, we have symposia that'll take place, et cetera, but, you know, we will, I think, demonstrate what's to come, which is leadership in the MASH space for many years.
Mm-hmm. Well, that's very exciting.
Mm-hmm.
Maybe just to close out, what do you think is most underappreciated about Madrigal?
Yeah. What's most underappreciated about Madrigal? I think it starts with there is this lack of being able to see the opportunity in MASH by, I think, I still think with the investment community, because it's been a series of so many disappointments, and sooner or later you say, "Gee, I'm." You know, "You have to, you have to prove to me before I really believe." And I think there's a little bit of, you know, Madrigal, it's a small company. How is it that this is the, this, 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.
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 gonna be a market? You know, 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, you know, the Sanofi Genzyme business unit. And, you know, so I think that's what's underappreciated at the moment, you know?
But we are going to be able to organize ourselves, resource ourselves, especially with the recent $500 million raise that we did. We're gonna be ready to go. Now, it's not gonna 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, you know, we're gonna be ready to go, and we don't have a lot of time, but it's fun, and we're attracting great people that wanna get on board this, I think, really wonderful journey that we're on, but the new chapter is gonna be turned.
Mm-hmm. What do you think is the biggest challenge commercially?
Biggest challenge commercially. Look, I think that it is just time, right? The biggest challenge is, you know, March 14th is around the corner. You know, I've literally, you know, just arrived seven weeks ago, so it's just, you know, accelerating all of our planning to make sure that we are 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. When we, I'm not suggesting we're behind, but, you know, you're building for a game that doesn't even exist yet, which is the treatment of MASH. So that just adds a few more complexities to say, "Okay, it's, you know, 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 gonna be there, but, you know, you always wanna 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.
Mm-hmm. Great. Well, thank you so much for the time. Very much looking forward to a hopefully successful drug launch.
Thank you.
And approval.
Thank you.
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.