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spk10: Good day, and thank you for standing by. Welcome to Matagroup Pharmaceuticals' first quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. As a reminder, today's conference is being recorded. I would now like to introduce Ms. Tina Ventura, Chief Investor Relations Officer. Please go ahead.
spk12: Thank you, Lisa. Good morning, everyone, and thank you for joining us to discuss Madrigal's first quarter 2024 earnings call. We issued a press release this morning. There's also a supplementary slide deck that accompanies this webcast that we'll post immediately following the call on the investor relations section of our website. On the call with me today is Bill Sibbel, Chief Executive Officer, and Marty Deer, Chief Financial Officer. They'll provide prepared remarks, and then we'll take your questions. We're shooting to keep today's call to about 45 minutes. Please note, we'll be making certain forward-looking statements today. We refer you to our SEC filings for discussion of the risks that may cause actual results to differ from the forward-looking statement. With that, I will now turn the call over to Bill.
spk03: Well, thanks, Tina. Good morning, and thanks to everyone for joining the call today. Before we begin, I wanted to take a moment to acknowledge Dr. Stephen Harrison, who passed away at the end of April. Becky and I attended his Celebration of Life last week, Stephen was a leader in the field and a great partner with Magible as our principal investigator for the Maestro NASH trial. He worked closely with Becky and had the same tenacity and determination to bring ResDifera through clinical development and ultimately FDA approval as the first medicine approved for NASH. We're grateful for his years of dedication that advanced this field, and our thoughts go out to his family, friends, and colleagues. I know that many of you listening to our call today knew Stephen well. I'll now move to our earnings call and an update on the business. We are off to a terrific start in 2024 and have made substantial progress against our goal to establish Magigal as the clear leader in NASH. We achieved US FDA approval on March 14th. This followed the landmark publication of our phase three trial in the New England Journal of Medicine. Following approval, our field teams were deployed and Magigal patient support program was up and running. In April, we started shipping product to our specialty pharmacy network, and most importantly, patients started receiving ResDifera. From a supply perspective, we are confident in our ability to fully meet demand. As we work to expand our leading position in NASH, we're also focused on maximizing the value and future growth of ResDifera. To that end, so far this year, we submitted ResDifera for approval in Europe Our MAA was validated, and we expect a decision in the first half of 2025. We continue to advance the Meister NASH outcomes trial in F2, F3 patients, and we have the potential to provide first-in-disease outcomes data years ahead of others. We continue to enroll our outcomes trial in NASH patients with cirrhosis to expand the eligible patient population, which has the potential to double the res differ opportunities. And finally, we raised $690 million in gross proceeds from our public offering. As of March 31st, we had $1.1 billion in cash on our balance sheet, enabling us to fully resource the launch. So, we've accomplished a great deal through the first quarter of this year, and are laser-focused on a successful U.S. launch of ResDifera. You've heard my enthusiasm since I joined Magical. about this opportunity, the clear unmet need, the product profile, and the strong label. And my reason to believe has only been reinforced with the launch. I've been out in the field since approval, engaging with the community, and the feedback has been overwhelmingly positive. My sample size isn't small. I've met with more than 100 prescribers at their offices, in the field with our reps, at our speaker trainings, and at conferences. And as I think back on the launches that I've led in my career, I haven't seen this level of anticipation for any new drug launch that I've been part of. I'm more confident today that ResDifera will be a significant success for Madrigal and especially for the patients that have been waiting for this therapy. Much of the positive feedback has been about the ResDifera product profile. On slide four, as we discussed on our approval call, Resdifera has a best case label that positions it as a foundational therapy in NASH. We have a great indication statement. Resdifera is indicated in NASH patients with moderate to advanced fibrosis, exactly the patients we studied in our trials. There is no biopsy requirement. It's a liver-directed, oral, once-daily pill with simple weight-based dosing. And there are no contraindications, no box warnings, and no monitoring requirements beyond standard of care. We have the enviable position of being the first to market in NASH, which we believe will give us a strong and sustainable competitive advantage. First to market medicines usually achieve and maintain higher market share versus subsequent entrants. We intend to take full advantage of this opportunity, positioning ourselves for long-term leadership. As we're first to market with the product profile that's incredibly strong, as you can see, on slide five. It's a liver-directed medicine that has set a high bar for efficacy, the only medicine to achieve statistically significant results on both endpoints in phase three, NASH resolution and fibrosis improvement. Importantly, ResDifera stops or improves fibrosis in more than 80% of patients after only 52 weeks or one year of therapy. It's well tolerated with safety data in more than 2,000 patients And we've resourced the launch the right way to build toward our aspirations for peak sales. So while Madrigal, the company, might be launching its first-ever medicine, our commercial and medical leaders are veterans. Each has more than 25 years of industry experience and have launched dozens of blockbuster medicines. Our field team averages nearly 20 years of experience with strong hepatologist and gastroenterologist relationships. We have the team, the talent, and the resources to make this launch a success. With this product profile and first-marked advantage, as seen on slide 6, we believe ResDifera will be positioned as the foundational therapy for NASH patients with F2S3 fibrosis, now as the only FDA-approved medicine for NASH and for many years to come. The unmet need is significant and it's urgent. There are 315,000 F2F3 patients diagnosed today under care of the specialists we are calling on who need a liver-directed, well-tolerated therapy like resgifera that will stop or reverse their disease. These patients are on the cusp of cirrhosis, are at a 10 to 17 times higher risk of liver-related mortality, and don't have time to wait. Our trial in F4 patients with well-compensated cirrhosis is underway to expand ResDifera's indication to even more severe patients. Let's move to the ResDifera launch progress on slide 7. As we discussed on our approval call in March, over the first 12 months of launch, we are focused on wiring the system. With a first in disease medicine, it's about spending the necessary time up front with physicians and their office staff to create the care pathways for patients. This work builds the strong foundation needed to support the future volume of prescriptions we expect. We are making great progress. ResDifera has been added to the Compendia and subsequently to many electronic medical record systems so that it can be more efficiently prescribed. Our field team was trained on the ResDifera label post-approval, enabling them to start calling on their target physicians. Our teams are educating providers on the disease and ResDifera, as well as the operational aspects of prescribing and ensuring access for patients. This often takes additional calls up front to familiarize all key staff at the practice with these details and address their questions. This process will become more and more established as we progress through the year, particularly as commercial payers continue to make ResDifera coverage decisions and as physician offices become educated on those payer requirements. And we expect full Medicare coverage in place beginning early next year, which is another step towards having patients flow more efficiently through the offices. So to evaluate our early progress, we are measuring a number of leading indicators as seen on slide 8. It's about targeting the right doctors with the right level of frequency to build the breadth and depth of prescribers needed to achieve our aspirations. The metrics so far are very encouraging, especially since we're less than a month out from when product was shipped. We are driving breadth and depth. Our sales team has already reached more than 80% of their top physician targets. There is remarkable interest and our reps are getting access to physicians that typically don't see reps. They are engaging with the staff to ensure that many of those wiring the system activities I just discussed are completed to allow an office to more efficiently prescribe risdifera. And as payers increase their coverage of risdifera and physician offices build their understanding of the coverage requirements, the volume and pace of prescriptions will increase. We are targeting the right physicians. 75% of prescriptions to date are coming from our top targets. We are driving our efforts from the top down as well as from the bottom up. Wiring the system extends beyond individual practices to the large health systems, the IDNs, GI supergroups, the really large systems across the country. We have an experienced team that has strong relationships across these key accounts, and they are all interested in establishing care pathways for NASH patients that are at various stages of implementation. This means that a physician, through their EMR system, has a clear guideline to identify, diagnose, and treat their NASH patients with moderate to advanced fibrosis. Importantly, these pathways filter down to the associated individual practices. Another proof point that not just at a practice level, but at a system level, the launch is progressing well. We are educating healthcare providers on ResDiffra to drive clinical conviction for the medicine. We've held speaker training meetings, a national broadcast, symposia at conferences and local programs across the country. There is phenomenal interest to attend these meetings. More than 1,200 prescribers attended the national broadcast, a very high turnout compared to industry benchmarks. We are engaging with payers. To that end, coverage is in place for 30% of commercial lives, tracking right in line with our goal to achieve 80% by year-end. Our reimbursement team continues to have active dialogue with payers with a focus on the Comprehensive ResDiffer Clinical Data Set and the use of non-invasive tests, or NITs, as a means for patient identification and monitoring. We expect many of the larger plans, to begin to cover ResDifera in the months ahead as they work through the typical P&T committee processes and determine prior authorization criteria. The criteria we're discussing with payers and what we are seeing in early coverage are generally aligned with our label. We also expect medical societies, such as the AASLD, to publish updated NASH treatment guidelines that will include ResDifera and help reinforce for both physicians and payers how and when to use the medicine. Of course, we know you're interested in patient numbers, and we'll share more details on patients on our next quarterly call. What we've seen to date is really encouraging. Patient growth is accelerating, which correlates well with the leading indicators we just described, and the progress our team is making as we continue to call on more prescribers, spend time with the staff, and activate more accounts. The positive momentum we're seeing is also confirmed by market research, as noted on slide nine. 90% of physicians familiar with ResDifera believe it offers high clinical utility. More than 80% are enthusiastic about ResDifera's final label and cited its efficacy, no biopsy requirement, and simple dosing as the top three reasons. And in our most recent wave of research with our top physician targets, 78% of respondents said they have prescribed or intend to prescribe risdifera within the next one to two months. Spherics, an independent market research firm, reported similar findings with more than 75% of providers expecting to prescribe risdifera within six months of launch. We're engaging diagnosed patients in a very targeted way as well. Our direct-to-patient disease education campaign on slide 10 has been underway for a little over a year now to provide patients with NASH information and resources. Post-approval, the team is now focused on activating those patients to ask their doctor about ResDifera. Patients are engaged, and 50% of those who registered on the site have downloaded a doctor discussion guide. In addition to the US launch of ResDifera, we are making progress in other areas that will extend our leadership. including maintaining our scientific presence at key medical meetings. On slide 11, you can see we are building on our strong HEOR foundation with additional publications. At the recent AMCP scientific meeting, we received recognition for our abstract that showed NASH patients were progressing even more rapidly than we thought to advanced liver states like cirrhosis, liver cancer, liver transplant, and death. In fact, of those that progressed, 80% progressed directly to decompensated cirrhosis instead of cirrhosis as one would expect. The results are particularly impactful because this data is from an Optum database, which includes commercially insured patients that are likely receiving better care and are of higher socioeconomic status compared to NASH patients in other care settings. The annual cost per patient that's was two-fold higher when compared to those that didn't, with the cost gap increasing over time. The conclusion? Therapies like resdifera that help stop or improve fibrosis may help alleviate the financial burden of NASH. We will also have a strong presence at the upcoming DDW meeting in D.C. later this month and at the EASL Congress in Milan in June, where 11 abstracts have been accepted. As I referenced at the start of the call, we look to further differentiate and expand the ResDifera label with data from the outcomes portion of our pivotal phase three Maestro NASH trial and our Maestro NASH outcomes trial in well-compensated cirrhosis for F4 patients. As noted on slide 12, these studies will allow us to generate outcomes data years in advance of any potential competitor outcomes data, expand our indication, and further extend our leadership in NASH. Maestro NASH Outcomes is an event-driven trial enrolling approximately 700 F4 patients with a composite primary endpoint that assesses conversion to decompensated cirrhosis. There is an even higher urgency to treat F4 patients because of their elevated risk of developing serious and costly liver-related complications. Data from this study is anticipated in the 2026-2027 timeframe, and an indication in the F4 patient population could double the opportunity for res differ in the U.S. The potential for maestro NASH outcomes trial is supported by data we've shown to date in 180 patients with compensated NASH cirrhosis studied in the Phase III maestro NAFLD I and maestro NAFLD OLE trials. Before passing it over to Marty to cover the financials, let me wrap up with a brief summary of the launch. It's really remarkable how much we've accomplished in such a short period of time. We were able to achieve FDA approval in March with a best-case label and a first-to-market medicine. We had product in the channel in April, and our teams are out in the field executing. The feedback we're hearing from our customers is overwhelmingly positive. There is high interest, they have the patients, and they are prescribing ResDifera. I'm really encouraged by the early progress so far and even more confident today in the blockbuster potential of this medicine. I'll now turn the call over to Marty.
spk11: Thank you, Bill. The press release we issued earlier today contains our full financial results, so I'll provide a few highlights for the first quarter of 2024. As we discussed on the launch call, initial RISDFRA shipments to our specialty distribution network began in April, so we recorded no RISDFRA revenue for the first quarter. As Bill discussed, there is good momentum with the launch, and given the need to wire the system early on and our expectation for it to take 60 days on average to fill a prescription through the first six months of launch, we expect revenue to be weighted to the back half of the year, with modest sales in the second quarter. We are still in the early days of the Rezifra launch and would afford to share more about our progress in the coming quarters. R&D expenses for the first quarter of 2024 were $71 million compared to $62 million for the first quarter of 2023. This increase was related to timing of manufacturing, headcount growth, activities in our medical affairs group, and stock compensation expense. We would anticipate a relatively steady level of R&D expense for the rest of the year. SG&A expenses were $81 million compared to $16 million for the first quarter of 2023 and an increase sequentially from $47 million in the fourth quarter of 2023. This significant increase is as expected due to the scale-up of our commercial operations in anticipation of the March FDA approval of Rosifra. We hired the field team in January and February, so the second quarter will be more reflective of a full quarter of spend. Moving to our balance sheet, we announced an oversubscribed public offering that grossed $690 million for the company and further strengthened our financial position. Our net cash balance as of March 31, 2024 stood at $1.1 billion. Note that the green sheet from the offering was executed in early April and therefore an additional $86 million in net cash will be recognized in the second quarter. We are fully resourced to support a successful multi-year launch of BirthDipRest. Now I'll turn the call back over to Tina.
spk12: Thanks, Marty. Let's move into the Q&A portion of the call. We'd ask that you limit your questions to one, as our goal is to wrap up the call by 845. So Lisa, please provide instructions for the Q&A session.
spk10: Thank you. If you would like to ask a question, please press star 11 on your telephone. You will then hear an automated message. advising that your hand has been raised. We also ask that you please wait for your name and company to be announced before you proceed with your question. One moment while I compile the Q&A roster. Our first question today will be coming from Yasmin Hamani of Piper Sandler. Your line is open.
spk08: Good morning, team. Thank you for the updates. And maybe before I go with my question, I want to express my sincere condolences to you and the entire team of Madrigal for Dr. Stephen Harrison. He will be greatly missed of what he has done for the space. On my question, I guess, team, it would be wonderful if you could maybe highlight whether there is heterogeneity in the pair's discussions or if it seems that majority of the payers are aligned in terms of their requirements of just simple blood-based tests. If you could just talk about how many payers you have spoken with, the heterogeneity, et cetera, and I'll move back into the queue.
spk03: Thanks, Jez. Thanks, Jez. Thanks for the question. Thanks for the comments about Stephen. Look, regarding the payer discussions, First of all, I think it's still really early. We're out having conversations. Remember, we've been having conversations for a year with the payers, and I can tell you some of the themes. Some of the themes are, first of all, from a clinical perspective, there is tremendous interest in ResDifera in NASH. People are aware of the unmet need. They're very aware the payers are at the cost that NASH patients have to them. So great interest in learning about the product. learning about our outcomes, just learning about our approach. And the reason why I say the approach, what's resonated very well with payers is the fact that we're focusing on 315,000 patients. We are focused on those that are diagnosed that are in the office of specialists, which is also important for them. So that has been the starting point of all of our conversations. And whether it be a regional or a national player, we're out meeting with them. P&T committee meetings have been scheduled. We're getting some reads early on as you heard in the prepared remarks. We're at about 30% of covered lives now, commercial covered lives, well on the way to our target of 80% by the year end. And I would say that at this point, you know, There's no real surprises that we're having in these conversations, especially with the bigger plans. You know, we expect to get this resolved. Patients are still getting drugged. That's really the great thing. While this is going on, patients are moving through. We're getting prescriptions. Prior authorizations are required. Medical necessity in some cases. So, you know, right where we are right now is where I would expect to be. I'm happy with 30%. We're well on the way to the 80%. You know, there's always going to be some outliers that I talked about even before we launched. We're seeing a little bit of that, but, you know, that's certainly by no means the trend. Great.
spk12: Thanks, Yaz. Lisa, next question, please.
spk10: Thank you. And our next question is coming from Ellie Merle of UBS. Your line is open.
spk00: Hey, guys. Thanks for taking the question. You mentioned that 75% of prescriptions have been written by top targets. Can you give us any color on what proportion of your top physician targets have written a prescription? And then just in terms of the prescriptions that have been written, can you give us any color on physician feedback on the medical exception process? And are most physicians going through medical exceptions at this point when they prescribe ResDifera? Thanks.
spk03: Thanks, Ellie. So on the latter, I would say that most are going through medical exception at this point. That's completely what we would expect. In fact, if any aren't going through medical exception, that would be more of a surprise because, you know, there just isn't the established pathways yet. So just to give you the layout, the prescribers and where we're seeing, where we're focusing and where we're seeing the prescriptions. So the universe of physicians is about 14,000. Our target is physicians are about 6,000 of that and that's where we've said that we've seen we've had great success in seeing those physicians the reps have been out and had interactions sometimes you know a couple or three interactions with those high prescribers we and this is exactly what you'd expect in any launch is that those target physicians should drive the majority of your prescription and in this case we're really encouraged by the 75% of the prescriptions coming from that group. We haven't said how many have prescribed or anything yet, but these are all some stats as we get further along into the launch. Again, we've only had product out in the market for less than a month. It's still really, really early and difficult to project from such a short period of time, but all leading indicators, and that's why we went with the leading indicators, are very supportive of things going really, really well for us.
spk12: Great. Thanks, Ellie. Lisa, next question, please.
spk10: Thank you. And our next question will be coming from Lisa. Your line is open.
spk09: Hi. Thanks for taking the question. I wanted to ask about the VA along the lines of an earlier question about heterogeneity. and wanted to understand their requirement for a liver biopsy. And can you talk about how you interpret that, what you can do to lift that, and also what percentage of the 350,000 patients are part of the VA? Thank you so much.
spk03: Thanks for the question, Lisa. And, you know, look, the VA is pretty particular, right, in that if you're going to launch a product inside of a budget year, it's difficult because they have a fixed budget. And that requires congressional approval every year. So any changes to the budget are actually kind of problematic for them. So, you know, look, we are disappointed in the decision. It certainly isn't great for patients. It certainly is counter to any guideline that's been written anywhere that says the use of NITs is adequate. And that's certainly what we believe the field is. So, however, you know, the facts are the facts. That's where we are at this point. Now, as we look forward to 25 and it's a new budget year, you know, we're going to be working with the VA to have that corrected. You know, we think that certainly the guidelines and the medical community and certainly the patient community is on our side to have that happen. But, you know, this is just one of those things, as I said, as for the 12 months that you're wiring the system, sometimes you have to rewire portions of it. And in this case, this is one of those examples where just, you know, based on the number of those reasons, we find that that's the decision that they made.
spk11: Yeah. Makes sense. Sorry, Lisa, just adjusting in terms of the number of patients that the VA covers. It's very small. Perfect. So when we do a chronic mix and we have that 10% that's Medicaid and VA patients, it's in the single digits. So it's not going to be a large impact at this point, particularly in 24. Good.
spk12: Thanks, Lisa.
spk10: Thanks.
spk12: Lisa, next question, please.
spk10: Thank you. And our next question is coming from Jay Olson of Oppenheimer. Your line is open.
spk06: Oh, hey, congrats on the launch progress and thanks for taking the question. Can you just talk about some of the work you're doing to prepare for launch in the EU and also what your strategy is for launching in the EU and how that may impact your operating expenses? Thank you.
spk03: Okay. Jay, thanks for the question. We're really excited, as we said in the call, about the opportunity to expand geographically. And the EU is certainly a very interesting market for us. We announced in the first quarter, obviously, that we had filed. We're now working through the strategy for the EU. And this is the way we're making all decisions in the company. We're looking at one, three, five years from now. And where do we want to be? Where are we today? The realities of where we are today versus what we think we're going to grow and become. We want to be the leading company in NASH, period. We think that's achievable. And we think that obviously that's going to come not only through ResDifera, but we'll develop a pipeline and that's going to be geographic expansion as well. So we're working through those details. A little early for us to report out on them. We'll come back to you on a later call and be more specific about what we're doing in Europe. But it's an exciting moment for us to be able to expand globally, and we look forward to reporting out to you on it.
spk11: Yeah, the only comment I would make, Jay, because we are early in our decision-making there and mapping out the expenses, that the investment that we would make, the payback would be would be within the one to two years. That's how we look at, you know, our strategic decision making. So there would be an impact likely if we get approval in 25 and going into 26, but then it should pay itself back. And that's just looking at Europe specifically. Clearly the U.S. launch will cover a lot of the spend there in the EU. Great.
spk12: Thanks, Jay. Lisa, next question, please.
spk10: Thank you. And our next question is coming from Ritu Barrow. of TD Carlin. Your line is open.
spk07: Good morning, guys. I want to dig in a little further about the non-invasive algorithm for preauthorization that may be coming together in your insurance discussions. You know, per Yasmin's question, are you finding that things are mostly blood-based? Are you finding that there's a blood-based plus an imaging and, you know, which imaging is being preferred? And then how could that ultimately affect time to fill or how could these be affected by ASLB guidelines? Thank you.
spk03: Ritu, thank you very much for the question. Really appreciate it. And look, you know, it's still early in the process. Generally, payers are evaluating a menu of the NITs. There isn't 100% consistency across, and I think you've heard me mention even the community is still working through what's the best sequence, what's the best combination of NITs. I think that the guidelines have started to help with that. I think pending guidelines will hopefully, again, provide additional comments on NITs. Regarding the availability, and I think you kind of hinted to that, We don't see that as a limitation at the moment. Certainly any of the decisions that we've seen, the physicians in the area certainly seem to have access to those types of NITs. Between blood and imaging, I would say it's typically a combination of blood and imaging. But as we have more final decisions and we have trends, we'll be able to report out to you what that looks like. We're really excited about updated guidelines. We know the community's working on them. I think one of the things we have to remember, the guidelines are pretty set. What you need to do now is put ResDifera into those guidelines. So we're not expecting wild differences, we're just saying they've been void of a treatment before, now you'll be able to put ResDifera in there. But, you know, so I guess the conclusion is still early. We're seeing the gamut, if you will, of NITs. And it doesn't appear to be any kind of barrier to access to these where the decisions have been made. So physicians can test them. And this will be a continue to evolve field as I think the community kind of really, now that they have a product, Thanks about how to use NITs, how to sequence and combine.
spk12: Great. Thanks, Ritu. Lisa, next question, please.
spk10: Thank you. And our next question will be coming from Thomas Smith of Levery Partners. Your line is open.
spk13: Hey, guys. Good morning. Thanks for taking the questions and congrats on the early launch progress. I wanted to follow up on some of the early payer coverage and specifically on the VA decision. Do you expect to still have any read-through to how any other commercial or government plans are likely to cover ResDFRA, at least with their initial coverage policy decisions? And then, how important are updates to the treatment guidelines with respect to the payer discussions? Have you received any feedback from payers suggesting that this could help drive either more favorable coverage or less restrictive prior auth coverage? Thanks.
spk03: Great, Thomas. Thanks for the question. You know, first of all, Don't think there's a read-through there. You know, we're having independent conversations with each payer. And as I said, with the payers, especially the larger players that we're speaking with, there is a true, true acceptance of the seriousness of the disease, an appreciation for the clinical data, and an appreciation for how we're approaching the launch. So I think that they're independent decisions. I mean, people, you know, these payers all... make their own independent decisions. So we don't see the read-through. And the second question was the guidelines. Look, I think the guidelines are important. And as I said in the previous question, the guidelines that are in place are already being referred to. I think it will be helpful for the physician community and the payer community, though, to have updated guidelines that do contemplate Reddifera and provide a little bit more direction about how you would use it, when you would use it, et cetera. So we know that the various bodies are working on it, and we're hopeful that we'll see at least something draft in the not-too-distant future.
spk12: Great. Thanks, Tom. Next question, please, Lisa.
spk10: Thank you. And our next question. will be coming from Akash Tarari of Jefferies. Your line is open.
spk01: Hey, thanks so much. So do we have any early color on the patient enrollment forms? Are they exceeding your internal expectations? And when we think about rewiring of the system, Bill, you previously indicated we should not expect to see any significant revenues for ResDifera in 2024. Is that still the case? I just want to make sure we're clear on what expectations are going to be. And then maybe if I could sneak this in, if semaglutide shows a fibrosis benefit that's in line with resifra in its upcoming phase three trial, do you expect ULP1s to be step-headed by pairs ahead of your product? And would that affect your internal launch projections for next year? Thank you.
spk03: Okay. Thank you. Thank you for the questions. Let me see if I can get through them all here. Look, we aren't providing anything with patient numbers or initiations or anything at this point. It's just too early. I think it's pretty clear in the call that I'm really pleased with the way things are progressing with the launch. Our focus right now is really just wiring the system. If we don't build a strong foundation, we will not be able to push through high volumes of patients in the future. A lot of companies make the mistake that they just try to chase getting patients on drugs without preparing the practice payers and the whole system for being able to handle the flow. And we're focusing on that. However, we are still having patients come through, which is really great. So I'm very pleased where we are. I'm looking forward to, as we get through the next quarters, of being able to further wire and also to give you a report out on just how things are going. Your next question was about the... Expectation for revenue. Oh, expectation for revenue.
spk01: Marty, do you want to take that one?
spk11: Thanks. Yes. So, Akash, just to be really clear of what we said, we said because of the time to wire the system and the time for prescriptions to be filled for the first six months, which we estimate on average to be 60 days, but we think that comes down to 30 days after six months, that 2Q sales will be modest and that... sales for the year will really be back and loaded for Q3 and Q4. We haven't given a number for that. We haven't given guidance on that, but we are, we have validated and said where the street is as an average or consensus that we feel confident with. So that's the message regarding revenues for 2024.
spk03: And then the step at it. I mean, look, you know, I guess we'll find out more this year about if anyone manages to show the same impressive efficacy results that we have by hitting on both primary endpoints. You know, let's see. So, look, looking ahead to the future, you know, regardless of what happens, what they show, I think you have to come back to the facts. The facts are, first of all, that there's an incredibly high unmet need. There's 315,000 patients, so there's a lot of patients. and up until March 14th, there was not an approved therapy. Now, what was the therapy that was approved? Resdifera, and look at that profile. Efficacy, hit on both endpoints, greater than 80% of patients have a stop or reverse fibrosis. So the response is deep, and the response is wide. So we have effective product, that happens to be a once-a-day pill that has been shown to be well-tolerated and safe. So we've got a profile which is really a fantastic profile. I mean, it's every kind of drug maker's dream is to have a once-a-day pill for a serious disease. And I'll take that profile, and we will compete against anyone. especially since we're at the beginning of the market. We're not talking about a zero-sum game here where market shares are all locked in place and one person's going to lose share, one person's going to gain it. We're hopeful that there's going to be other products in NASH because it helps to grow the market. And we think that with our profile, which is still emerging. Look, we got approved on 52-week data, and we saw this as a 54-month study. We think some of our best days are ahead, actually, in showing what this product can do. So will they force a product, force a patient to go through a GLP-1? I don't know. We'll see what they do. But I think that on our profile alone, there is a very compelling reason for patients to be on Renzifera. So we're extremely confident under any scenario of what anyone else shows in beta.
spk12: Great. Thanks, Akash. Lisa, next question, please.
spk10: Thank you. And our next question will be coming from John Wolleman of Citizen. Your line is open.
spk02: Hey, thanks for taking the question. I'm wondering if you could talk about the patient services you're providing and if you're expecting patients to start on paid therapy after that 60 to 30 days or if there's going to be a lot of free drug in the system.
spk03: Okay, so John, thanks for the question. Do you mean the types of services that we're going to offer, or do you want more specifically how we see that mix of patients?
spk02: I guess the latter is more informative, but if you could speak to the first or the former as well.
spk03: Yeah, look, so we've put together a very comprehensive patient support group. We think that's really important. We think it's important that the first interaction that they have with the product through patient support is important and establishes kind of a long-term relationship, hopefully helps them navigate any challenges they may have along the way. Through Madrigal patient support, they get co-pay assistance, etc., If they are underinsured or have no insurance, they can qualify potentially for our patient assistance program to receive free drug, et cetera. So it's important not only on the front end, but also as you look over the long term, establishing that long-term relationship and helping through any kind of adherence challenges somebody may have. So we fundamentally believe that a strong patient support services group is important and we think that we've got really a great one that we started. Regarding kind of free drug and so forth, You know, look, you've heard me say before that as you look through kind of that first year, you've got patients that are, some are gonna be on free drug, will have a bridging program, et cetera. So it's a little bit choppy if you're thinking of it from a gross to net perspective for that first year. You know, what we've committed to the community is this whole notion of equitable access. You know, we don't want to, we want to be able to provide product to patients who need it. So we've focused on affordability for patients. If you're a commercial patient, you can have a $10 copay. You know, the challenge right now is with Medicare, since we missed the window for 24, we're now talking about what will happen in 25. So those Medicare patients are either going to have a opportunity through their own plan if they've made a mid-year decision, or some of them are going to have to wait for 2025. So we're going to try to help those patients. We'll look to see if there's alternatives for them, such as charitable foundations, et cetera. And in the end, if they can't get it through other means and have a high unmet need you know we'll provide a free product so we will have free patients but you know that's not where we are today we have patients that are coming through the system and they're paid prescriptions so we feel like we're in a really good place but we're always going to have this balance of some patients for their structural reasons won't be able to get drugs through that means we're going to help those patients but we're going to try to keep things in very much in sync between the various types of patients, whether you're insured, uninsured, commercial, Medicare. So that kind of is a little bit of more flavor around it rather than a real specific number that I'm giving you. But, you know, expect all those components, especially you'll see in this first 12-month period.
spk12: Great. Thanks, John. Lisa, it looks like we have time for one more question, please.
spk10: Okay. One moment, please. Our next question is coming from Andrea Tan of Goldman Sachs. Your line is open.
spk04: Thanks for squeezing us in. Maybe one question here on the prescriptions that have come through. Just wondering if you're able to speak about the dynamics that you're seeing to date. Is that generally one prescription per specialist or maybe multiple prescriptions per specialist? Thanks so much.
spk03: Thanks, Andrea. It varies, right? I mean, everyone starts with one, so to speak, or actually some have started with more than that. you know, one of the things we expect to see is in this top 6,000 or this target 6,000 is it's going to go beyond one and that they're going to go pretty deep, actually, because we know they have the patience and we know that there's a lot of favorable belief about res differa. So over time, you know, we're going to see, again, this notion of breadth and depth, and it's going to be concentrated in that top 6,000. So still pretty early. I mean, look, again, you know, What we found is that the physicians, until drugs available, weren't giving a lot of thought to how they were going to process all their patients. Now that drugs are available, they're making it part of their pathway in their practice, and that takes a little bit of time to think how they're going to do it. But we're really encouraged. Patients are being prescribed. Patients are getting on drugs. So we're kind of fulfilling our promise. We're trying to change lives here. And it's really exciting. And maybe I'll just end on that and say, this is a really great and exciting opportunity. As you heard me say, I'm more excited about the opportunity now than I was six months ago or three months ago. And it's just, I can't tell you how much fun it is to be out there with product that's so meaningful in a disease that has had absolutely nothing and we get to set the bar for all others that come there's you know it's rare that you get an opportunity to be the first one to establish how do you engage with companies what's the expectation you set for patient services and everything along the way we have that opportunity as the leader and our intent is to go out there and we are leading like leaders you know First launch, but we have a really experienced team. We know what we're doing. We have the resource. We have the product. The opportunity is there. It just takes time to get it right, build the foundation as we wire the system, and we'll put ourselves in a great position to win and be the leader in the space.
spk12: Thanks, Andrea, and thanks, Lisa, and thank you all for your time and interest today. This concludes our call. A replay of the webcast will be available on our website in approximately two hours. So thank you so much for joining us.
spk10: Ladies and gentlemen, thank you for your participation in today's conference. You may now all disconnect. Have a wonderful day.
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