Good afternoon, everyone. Thank you for joining our 35th Annual Healthcare Conference here at Piper Sandler. Excited to be hosting the team from Madrigal Pharmaceuticals. Joined through the fireside chat with me is Bill Sibold, the current CEO of Madrigal, and this is my first public fireside chat with you. So I'm really honored to get the opportunity to really talk to you. We have lots to cover in the next 25 minutes, so I'm gonna just go from bucket to bucket. But I think the first place to start is sort of just briefly touch on the NASH market, right? So based on the ICD-10 codes, you guys have said there are about 1.5 million NASH patients diagnosed in the US. Could you maybe give us a breakdown, what percentage of them are F2 versus F3? What percentage of that population falls through under the care of hepatology versus gastroenterology? Okay. Well, first of all, thank you for having us. Oh, thanks. Really appreciate it. It's, it's great to be here and see everyone. So, the 1.5 million, yeah, there's about 1.5 million diagnosed- Mm-hmm ... NASH patients, and about 35%-40% are F2, F3. Mm-hmm. And, you know, let me start there and, just remind you, the patient that we're targeting- Mm-hmm ... is NASH with significant fibrosis, F2, F3. Mm-hmm. It's that 35%-40% that we're targeting. Mm-hmm. Now, then, what lies beneath that- Mm-hmm ... and who's approachable- Yeah ... in the specialties that we're calling on? Because we are focused on hepatologists and gastroenterologists. We're still working through the complete epi of how many are sitting exactly in those practices. But when you, if you look at kind of the range of that 35%-40% on the 1.5 million, you're in that, you know, 500,000-600,000, and it's a segment within that. So we think that most of the patients are under the care of one of the specialists. So you have an approachable population, which is- Mm-hmm ... you know, really A, approachable and B, sizable, and that does not include anyone who later progresses from F0- Yeah ... or F1- Mm-hmm ... anyone, any new referrals or any newly diagnosed- Yeah ... patients, right? So, we think that's a good number. And as we get a little bit- Mm-hmm ... closer to launch, what we're gonna do is we're going to really walk through the real key assumptions- Mm-hmm ... epi and so forth. Yeah ... obviously saving price- Mm-hmm ... until we have approval. I think the question... Thank you for that. I think the question also comes up is, this is your—the study was run in F2, F3 patients. The FDA has been clear. Is there less, and you guys have also recognized the ICER pricing, and you have talked about specialty pricing. Is there a chance that as you engage with the agency, there is a price by which you could get, payers would say, a reimbursement for F2 or F3? Is there a potential price that you could be above, but could only be for F3? Like, how do you think the will play out? I guess my question is, what is the... Is there a price that could dictate both F2, F3, or potentially payers could say, "Ooh, that's a little high. Let's just only put the F3s on it? Yeah, look, I'm not. That's not what we're anticipating. Yeah. I mean, I think one of the- Mm-hmm ...one of the things that I've found in coming to the company. Well, two things. One is that- Mm ... it was an exceptional development program. Mm. Incredibly complete. Mm-hmm. I think set a high bar for any other company, any other product trying to enter the NASH space. That's number one. Number two, I'd say the pharmacoeconomic- Mm ... work that's been done- Mm ... has been outstanding as well. I think it's best in class. I think both, both these things are best in class. Mm-hmm. So that puts you in the best position. Mm-hmm ... when you're going in to have conversations with payers, because it's not as though you're waiting. Mm-hmm. You are coming with a data package and supporting- Mm-hmm ... evidence that talks about the value of the product. Mm-hmm. So, you know, we don't anticipate, and this is true, I would... Today, for any product launching, you know, conversations with payers. Mm-hmm ... are, you know, they're never easy conversations. Mm-hmm. Right? It takes a lot of work. Mm-hmm. The better prepared you are, the better result you have, and we feel like we have a very compelling package- Mm ... of information that would lead to F2, F3 patients having access- Mm-hmm ... to the product. Now, you know, clearly, we haven't decided price. You know, I believe very strongly in pricing for the value of the product. I think that, you know, clearly we've shown that if we can prevent some of those expensive downstream effects- Mm-hmm ... And you know, oftentimes, it's not just waiting for liver transplant or liver cancer- Mm-hmm ... or other complications. When somebody moves from compensated to decompensated, the cost of the patient to the system rises like sixfold. Mm-hmm. Yeah. So we're trying to get in those patients that aren't too early, but they've already kind of gone over the cliff- Mm-hmm ... in the sense of they've accumulated this scarring, fibrosis. In this F2, F3, that is a good point of intervention that prevents the long-term- Mm-hmm ... potential impact of cost. Okay. When you discuss with payers, do you see, like, questions around how do you find patients in need? Do they recognize? Because the biggest fear from investors are that payers may require a biopsy for eligibility to be put on therapy. Like, have any of those conversations led to, or do they understand the risks associated with, with biopsy and therefore really recognize that-... really not an optionality. Yeah, look, biopsy really hasn't been part of the conversation. Okay. Right now, it's been about education. Mm-hmm. It's been about education of the disease, education of Mm-hmm ... about, the patients- Yeah Education about our development program, etc. So, you know, there's, there's a lot of learning to be done. Mm-hmm. The world doesn't know so much- Yeah -about NASH. Yeah. Right? Even though, you know, the liver is such an important- Mm-hmm organ, it doesn't get a lot of attention. Yeah. We're starting to put a little bit more attention on it. You know, regarding specifically the biopsy, right now, it's only about 2% of patients- Mm-hmm Have a biopsy to confirm diagnosis. Mm-hmm. You know, a biopsy in itself is not definitive. Mm-hmm. because you have a very thin slice of the liver- Mm-hmm that you're actually looking at, that may not be consistent Mm-hmm with the whole liver. And then reading the slide. Mm-hmm from the biopsy oftentimes can be Mm-hmm challenging as well. Mm-hmm. You know, we do see the world moving towards NIT. Yeah. We think that as they get better and better, and as people think about the sequencing of it, get used to it- Mm-hmm ... and then there's a product that they have to be thinking about afterwards. So there's a solution rather than just the diagnosis. We think that's going to continue to evolve, get better over the years, and that there'll be less reliance on biopsies. So you as a sponsor, you may get the question from the payers if they propose that to you. Do you want physicians to pick their own NITs to diagnose patients and monitor? Or do you, as a sponsor, want a standardized NIT that everybody needs to use to identify and measure progression? Which one would you like to do? Like, would you just let the decision-making be in the hands of the physician, or would you want to kind of set a standardized protocol? Yeah. Well, I think that realistically, it's going to be the community making the decision- Mm-hmm as there's more and more data. Yeah. Right? I think that, in the community right now, people are getting used to- Mm-hmm Using the different NITs. Some people have an opinion about what they prefer. Yeah. Some people are quite happy with Mm-hmm -Fib-4 and FibroScan. Yeah. Others would like to be using ELF, etc. And so I think, you know, this is that, kind of market building- Yeah that I'm talking about, where since there hasn't been a therapy- Yeah ... I don't think some of those, guidelines, pathways have been- Mm-hmm so firmly established. Mm-hmm. There's innovation taking place now as well, where, you know, there may be additional- Mm-hmm - NITs or, combinations of NITs- Mm-hmm -that give- Yeah An answer for the treating physicians. So I think we wanna be a part of that discussion. Mm-hmm. We have a lot of data at AASLD. You know, we presented some of that work- Mm-hmm on NITs and the relationship to biopsies. So, you know, I think it's an evolving field. It's gonna get better and better and more established in time. Mm-hmm. We don't think that out of the gate, that is going to be- Mm a barrier, because each of the physicians- Mm has access to something. Yeah. And so it will refine in time. Yeah. Okay. The other question that we get quite a bit is like prior authorization, right? So as you're seeing payer discussions, let's say you come up with specialty pricing, what would the prior authorization protocol be if there would be one for NASH? Yeah, look, it's a little early to say. Mm-hmm. I would fully expect, though, that we would need prior authorization. You know, in any of the products that I've been associated with- Yeah In the last 11 years, everyone's needed a prior auth. Yeah. I don't consider that- Yeah -a challenge. Also, since we're talking about hepatologists and gastroenterologists, you know, they're actually quite skilled- Mm-hmm at managing the prior auth Yeah ... process and securing access- Yeah to products. And I think in this case, you know, it's really with resmetirom being liver directed- Yeah and them being focused on the liver, I think that it's something that they will feel very comfortable in, advocating for and ushering through the reimbursement process. Okay. What do you envision our prior authorization to be? I don't even know what people could ask for. Like, lose weight? Well, I mean, look, I think that, certainly when we talk to physicians- Yeah ... they've tried that- Yeah with patients. You know, right now, that is indeed the standard of care. Yeah. Go home, lose weight, take care of yourself, and then they come back- Yeah you know, lo and behold, not a lot's happened. Yeah. Yeah, that's helpful. The next question is sort of label, right? So, we talked about how payers are not gonna require biopsy. There's also fear among some investors that because the studies were conducted biopsy-proven NASH, that the FDA could... Like, so far, based on all your regulatory discussions, like, do they understand the risk of biopsy? Do they, do you get the feel that they can visualize biopsy being standardized and needed on a label? Or, like, that's the other thing that most people are looking for. Yeah, look, I think the FDA understands biopsy- Yeah Very well. I think you have to draw a distinction- Mm-hmm -between development- Yeah ... and then, approved products. Yeah. The FDA typically doesn't weigh into- Yeah prescribing to a physician how you should diagnose. Yeah a disease. Especially since, as I was saying before, biopsies are not- Mm-hmm a certainty in Yeah - their results. Yeah, that's right. So, you know, I think that the agency understands that well. Good, that's helpful. And then, I know as of right now, some people are really also nervous. You got Priority Review. You also noted no AdCom. I don't know if we're in that window. What's that window before you can be 100%, like, for sure we're out of the cycle of no AdCom? I don't know if we're there, and I think it's 90 days. 50-55 business days- Okay. of advanced notification you have before Okay an AdCom. Okay. That's it. That's just not specific to our- Okay That's just FDA policy. That's, like, around the same time, like, with... Although I guess, no, it's business days, March twenty-sixth, so we have a little bit. March fourteenth, counting back, it's- Counting back. You know, no one's counting, but Yeah -you know, it's about 72 business days- Okay. -away. All right. Okay, so if we don't hear by end of the year, no AdCom, we are in the clear. Well, I mean, look, you're not, the way I view any review, not specific to resmetirom- Yeah You're in the clear when you have approval. Yeah. Up until that point- Yeah A matter of regulatory review. Yeah. You know, I've had in my experience, where things get wrapped up early- Mm-hmm and when things get, Yeah pushed to the absolute Yeah last minute. So, you know, it's, it's too early to tell. Yeah. But certainly, you know, as we had said- Yeah The FDA indicated to us that there was no AdCom required at that moment. Mm-hmm. And, you know, that they obviously reserved the right to ask for an AdCom. And, we've also committed to the community, obviously, anything material we'll announce, or anything important we'll announce to the community, so. Okay, that's helpful. The other question that now, now fast-forward, like, we talked about potential label, no biopsy, is publication, right? I think the publication, I think a lot of investors recognize publication being present, you can also start engaging with payers, et cetera. Where is the team in that regards on... Is that something that we could expect in 2023 or more like a 2024? We're running out of days in 2023, aren't we? Yeah. It's kind of scary that it's- Yeah ... as late in the year as it is. Yeah. Look, you know, publication's really important. Yeah. This is, I think, going to be a real seminal- Yeah publication for the space, clearly, as a- Mm-hmm ... That's because it is such a robust- Yeah -development plan. Yeah. You know, [inaudible] and team have done just such a great job. It's a very rich source of data. Of course, it's a priority- Mm-hmm but, you know, our number one, two, and three Yeah priority are approval Yeah -in the U.S. Number 4, 5, and 6- Yeah our launch in the U.S. Yeah. So, you know, we think that a publication's important. You know, we've set a very high- Yeah standard for ourselves. Mm-hmm. We want this to be a high-quality publication. It's something that we're working, I would say, very, very hard on. Yeah. It's very helpful. The one other thing, so once I get clients comfortable about approvability, no biopsy onto the label, the part that then they have a challenge is, this is, you're the first to market in a very in a large indication, and you only have, like, less than 4 months left, right? Like, to really build this commercial footprint. So could you maybe, for those investors who would be, like, skeptical that you can do this in such a short period of time, especially of an uncharted territory market- Yeah ... What can you tell them, that I'm doing this and this, and this, and this- Mm-hmm that you may not be aware of, but all of these things tells me that we're going to be successful? So if you could just kind of capture that, I think it would be very, very helpful for clients. Sure. No, glad to. Look, I think you captured it well in saying that it's a wide open market, nobody's launched before, you have all this to do. That's what makes this such a great opportunity. Mm. I mean, I think, believe the notes that you take on your paper- Mm As to what's an attractive market, what's an attractive product, what's an attractive company? And I think you'll find all those. That's the reason why I'm here. I came because I think- Mm This is the single best opportunity in the entire industry, Madrigal, resmetirom, and launching into the graveyard of drug development, NASH. Mm. Finally, somebody cracked it. You know, hit on both endpoints, Priority Review, Breakthrough Designation, great profile, a liver-directed therapy that's shown to be safe, effective, well-tolerated- Mm -convenient. Mm-hmm. Once a pill. Obviously, with the caveats, you know, you know... It's not water you're taking- Yeah either, right? So now you've got this patient population, which doesn't have anything off-label to even use. Mm. You know, most of these diseases that- Mm I've had to launch, and there's always been other products that you would be using as a hope. Yeah. Here, it's go home, lose some weight- Yeah and, you know, we'll Yeah We'll hope that your NASH gets better. But there's not even that. So you've got patients that have nothing. Mm. They are on a bad course. F2, F3, you've kind of started that- Mm-hmm -that cascade, that, pathway, if you will, down to having more- Mm -serious complications. So now you've got, a targeted physician population- Mm-hmm and completely reachable by a Mm -small company. Mm. It's a specialty launch. Yeah. You've got a focused group of patients. You know- Mm We're working in that. Yeah hundreds of thousands- Mm-hmm range. And you've got no competition for, from our measures- Mm-hmm -years. You get to build a market from scratch. So the rush to launch- Mm. You know, we're building not for launch, we're building for peak. And let me explain that. I mean, we have to launch, and o- Mm-hmm Launch is important, but the way you launch is you build the right foundation... You make sure that the physicians are educated, that patients are educated, that there's a clear what the system's wired for them, for a patient to get to a practice, for a patient to get a prescription, for the prescription to be filled, for the patient to be able to have a good experience while on the prescription. We build that, so then volume can start flowing through. Mm-hmm. So the plan is to build that foundation as we get into 2024, and then that's with an eye on the future and how do you build a very significant brand- Mm-hmm. Create a leadership position in the space, and put yourself in a position to build a company around that opportunity. Mm. That is what you should be looking at and believing on a piece of paper. And, you know, yes, there's uncertainty because nobody's done it- Mm. But there was uncertainty in other markets that I've been a part of building. Atopic dermatitis. Mm ... I remember when that was a question mark. I think that's turned out pretty well. Mm-hmm. Right? Yep. That's what people are, I think, missing and have to just believe what the opportunity is. Mm-hmm. That's helpful. I think one of the things, at least we were at the Liver Meeting, I think we asked many, many doctors that were at the Liver Meeting who had an awareness of Madrigal or resmetirom. I think our clients can say the same thing. The survey is very consistent. Everybody wants to use the product and put their NASH patients on it. The only fear that I have is, okay, what is the population of hepatologists that show up at the Liver Meeting? How representative is this population that you're gonna be calling on? So my worry in my head is, I just wanna make sure that all these people that are in this room are called on. So could you maybe, you know, like this mapping that's being done, right? In the calling list and the high prescribing NASH centers, like, can you get this done? Can you figure this mapping out really sufficiently so that as soon as this drug is launched, you can go out there, and suddenly you have some of these centers- Yeah. You have hundreds. Yeah and thousands of patients. Yeah, we can. Yeah. I mean, you know, you know, going back even to the last question, the timing. Yeah. I've never had a run... a launch where it isn't a rush- Yeah ... in the end. You know, but we're very clear now what we want. We know who we're calling on, we know who the target patient- Yeah Is, right? We're, we're building the team. Mm-hmm. We're building a team that has experience in hepatology and gastroenterology, so they know the practices, they know the physicians. Mm-hmm. That gives them an ability to interact immediately with credibility. Mm-hmm. We're training people well. We're hiring, I think, a, you know, a excellent, excellent team. There are enough patients. Mm-hmm. Will we get the targeting 100% right on day one? You never do. Mm-hmm. Because there's people that you didn't know had a lot of patients- Mm-hmm ... that do, and people that you thought, don't. Mm-hmm. You adjust. It is a learning experience- Mm-hmm And you continue to move to what you're learning on a day-by-day basis. Now, we think that we can very accurately- Mm ... target the majority- Mm-hmm of where the patients are very quickly. And so day one, I have absolutely no doubt that we'll be calling on the right physicians. We will adjust that in time, though, and we'll grow that in time as well, as NASH becomes much more of a treatable- Mm-hmm ... disease. When I say treatable, that there is an option to actually treat. Yes. Do you think that... So what have you communicated in terms of the size of your sales force? How do you visualize sort of the cadence of the hiring and, and then being in place? Yeah. So look, we have a stake in the ground March fourteenth. Mm-hmm. That's what we are building our plans around. Mm-hmm. So we have the leadership, sales leadership in place. We are actively hiring, or I should say, interviewing reps. Mm. As the calendar turns. Yeah ... we'll start to add them to the company. So it is... You know, there's no- we're not being tentative. We have every expectation- Mm -that we are going to be March fourteenth, and that's when we wanna have our team deployed and ready for. Mm-hmm. Mm-hmm. Okay. Regarding sizing, you know, we're not giving away the full details on sizing. If you look in specialty launches- Mm-hmm ... they tend to have somewhere between 150 and 250 sales reps. Mm-hmm. you know, we'll provide a little bit more of an update as we get closer. Thank you. Then I think 2020, end of 2022, Madrigal had outstanding data, led to significant share gains. Stock was really strong. Then I think there was a very high anticipation of takeout. And as month by month went by and takeout didn't occur, the stock sort of faded away, faded away. And here, you said, discussed really this exciting opportunity for this product. A lot of clients will say, "Okay, I get it, but if this is really as good as it's supposed to be, why the, why hasn't somebody already acquired them?" Why hasn't that already occurred? Like, why do I need to wait for them to approve this and launch it? You know, so I guess the question here is, how much is the approval a big component of the strategic discussions and partnerships, and what is your vision that you have in terms of- The- You know, is it ex-geographies or? Maybe starting where I've come here to build a great company. Mm-hmm. That's the goal. Yeah. Be leaders in NASH. I believe that resmetirom is a product that you can build- Mm ... a company around, and there aren't many in the industry. Mm-hmm. There aren't many companies that survive long enough to actually execute- Mm ... visions. Mm-hmm. You know, I think we're kind of that one in a thousand- Yeah ... that has a chance. Yeah. My focus, my team's focus will be: how do we create value? How do we build value? How do we get to lots of patients? Mm-hmm. That will make a valuable company. How do we think about what's next in the future? If we're gonna have a great start with resmetirom, are there other things we would add to that? Yeah. We will look at that in time. You know, again, reminding- Mm ... the priorities are approval- Mm-hmm ... and launch. Now, why wouldn't it, why don't companies move? And I, having just been on the big pharma side, you know, when if you look at the other side- Mm ... of the ledger. Mm-hmm ... of the notes I told you to take- Yeah ... graveyard of drug development, product hadn't been filed or accepted, I should say, not approved. Yeah. There's been this kind of cloud over- Mm-hmm ... the world of GLP-1s- Yeah ... of every indication, every industry, everything. So that's enough where someone is going to say, "I don't want... my job isn't to create uncertainty, as, you know, a CEO of a big pharma company." They want more certainty. Yeah. So, you know, it's not a surprise to me that people wouldn't look at any opportunity that isn't, you know, either in an established market and you have a... You're just looking at product profile or whatever. But again, you know, I can't get, I can no longer be in that headspace of what pharma thinks, because I'm now in a smaller company that I think can be a bigger company. My focus, our focus is really gonna be great launch, build a company. Mm-hmm. Beyond that, we can't control the external world. That's great. Well, Bill, I'm super excited for you for 2024. I hope to sit here with you next year and see an approved product, an incredible launch, and celebrate the value that you have created. I wanna say thank you on behalf of all of us here at Piper Sandler. I will look forward to that. Thank you. Thank you very much. Thanks.