Madrigal Pharmaceuticals, Inc. Q1 FY2025 Earnings Call

Thank you, Tawana. Good morning, everyone, and thank you for joining us to discuss Madrigal's first quarter 2025 earnings. We issued a press release this morning and have a slide deck that accompanies this webcast, which we'll post on the Investor Relations section of our website right after the call. On the call with me today is Bill Sibold, Chief Executive Officer; and Mardi Dier, Chief Financial Officer. They'll provide prepared remarks, and then we'll take your questions. We plan to keep today's call to about 45 minutes. Please note on slide two, we will be making certain forward-looking statements today. We refer you to our SEC filings for a discussion of the risks that may cause actual results to differ from the forward-looking statements. With that, I will now turn the call over to Bill on slide three.

Thanks, Tina. Good morning, and thanks for joining. Today I'll provide an update on the significant momentum we continue to build with the US launch of Rezdiffra. I'll briefly recap the impressive two-year F4c data we shared on our last earnings call, which has since been selected as a late-breaking oral presentation at the EASL Congress in Amsterdam next week. We plan to review this data in an investor webcast following EASL on Tuesday, May 13th. And I'll close with a review of our strategy to expand our leadership position in MASH. But before we move to the quarter, I want to take a moment to recognize Becky Taub, Madrigal's Founder and a driving force behind the development and ultimate approval of Rezdiffra. As we announced in April, Becky is taking on the new role of Senior Scientific and Medical Advisor and she will continue to serve on our Board of Directors. And we are very pleased that Dave Soergel joined us on April 21st as our new Chief Medical Officer succeeding Becky. Becky's vision, pioneering work, and relentless drive led to the development and approval of the first ever FDA-approved medicine for MASH. This is a landmark achievement in our industry and one that has already changed the lives of thousands of patients. It's also changed Madrigal. We transformed from an R&D focused company to a fully integrated commercial stage organization. Dave brings more than 20 years of leadership experience in metabolic and cardiovascular disease drug development spanning both biotech and large pharma. He was most recently the EVP and Global Head of Cardiovascular, Renal and Metabolism Development at Novartis where he was overseeing 10 late-stage clinical development programs. We believe Dave is the right leader to take the reins at this critical juncture and build on the foundation Becky created. Along those lines, I'd also like to highlight the recent addition to our Board of Directors, Jackie Fouse. Jackie brings a depth of experience from her leadership roles at several successful biotechs including Agios and Celgene. I look forward to working with her as we continue to grow the company. Now let's turn to slide four and Rezdiffra's first quarter 2025 performance. We're a little more than 12 months into the launch of Rezdiffra and what a difference a year makes. We've gone from zero approved MASH treatments and no market infrastructure to securing FDA approval in March 2024. Launching with the best-case label and a world-class team, achieving over 80% commercial payer coverage, helping lay the foundation, practice by practice to build the infrastructure required for patient treatment, treating more than 17,000 patients who previously had no options and generating $317 million in net sales in our first 12 months on the market. By any measure, this is an exceptional launch, and we know that because we're benchmarking ourselves against some of the most successful specialty medicine launches in the past decade. Whether it's patient growth, depth and breadth of prescribing, payer coverage, or net sales, we're performing at or near the top. But the most exciting part? We're just getting started. As we enter year two, we're bringing the same intensity and focus on execution that got us here, and we believe the best is still ahead. This momentum carried us into another impressive quarter, with first quarter 2025 net sales of $137 million, up 33% quarter-over-quarter despite the typical headwinds we see in Q1 across the industry. Our patient support and field teams did a great job navigating those dynamics to keep patients on therapy. And we're continuing to generate strong demand and steadily add patients into the second quarter, driven by the urgent need Rezdiffra addresses, its compelling product profile, and the exceptional execution of our team. In addition to net sales, we continue to make great progress on key performance indicators that are driving our launch. First on patients, as shown on slide five. We ended the first quarter of 2025 with more than 17,000 patients on Rezdiffra, up from 11,800 patients at the end of the fourth quarter of 2024. This figure represents patients actively on therapy, accounting for any discontinuations, making it the most rigorous and meaningful metric to track sustained treatment adoption. And when we compare it to other top-tier specialty launches, we're adding patients at a rate that's consistent with those benchmarks. And yet we're still in the very early innings of this launch. Only about 5% of the 315,000 diagnosed F2-F3 MASH patients who are currently under the care of our target prescribers are being treated with Rezdiffra. We also see that awareness is driving action. Our disease and product education efforts are preparing patients to have better conversations with their MASH specialists about their care. We remain focused on those 315,000 patients, which represents a highly attractive specialty market. Looking ahead, the stated efforts of the next entrant are focused on expanding the market to many multiples of our initial target market. We believe that the strength of Rezdiffra's efficacy and attractive real-world profile positions it for leadership in either scenario, creating multiple paths to success for Rezdiffra in the years ahead. Moving to slide six, in our progress on physician penetration. Across the many launches I've led, one thing is clear. Building a strong base of prescribers early in the launch is one of the best indicators of long-term success. That's why the pace at which we've added new prescribers has been so encouraging. In just a year since approval, 70% of our 6,000 top targets have prescribed Rezdiffra. This level of penetration puts us at the high-end of the benchmarks we track and shows we built a strong foundation of healthcare providers who believe in Rezdiffra and are seeing the benefits. Achieving this type of uptake this quickly is the result of the work we've been doing since day one. Wiring the system for a first in disease launch like Rezdiffra is no small feat. We built and deployed a world-class team. We educated physicians on a disease that had no approved therapies. We partnered with payers to secure broad access and worked hand in hand with practices to help create the infrastructure needed to support sustained prescribing. As a result, more and more practices are integrating Rezdiffra into their standard of care. We're driving the same momentum as we establish a strong base within our 14,000 total targets to support the significant peak sales potential we expect. At the end of the first quarter of 2025, approximately 50% of the 14,000 target prescribers had prescribed Rezdiffra, up from 40% at the end of the fourth quarter of 2024, reflecting a growing and durable foundation. Our in-office support and cross-functional field engagement are not only driving breadth, they're also driving depth. We are steadily turning new writers into repeat prescribers and seeing more prescriptions written per provider that has consistently increased quarter over quarter as well. Rezdiffra's broad uptake is being driven by its attractive real-world profile. A medicine's profile often diminishes once it enters the real world. With Rezdiffra, we hear the opposite. Physicians and patients continue to highlight meaningful improvements they see on the efficacy measures that matter most to patients such as liver stiffness, liver fat, liver enzymes, LDL, and triglycerides. And our Phase 3 data demonstrate that Rezdiffra halts or improves liver stiffness in 91% of patients. As a once-daily, well-tolerated pill with simple dosing, it's also easy to take. We're seeing strong early signs of adherence with rates that are comparable to other well-tolerated oral therapies. We believe Rezdiffra's liver-directed mechanism, strong efficacy, and attractive real-world profile will translate well from F2-F3 MASH patients to those with F4c or compensated MASH cirrhosis as noted on slide eight. As MASH progresses, it can lead to cirrhosis marked by significant liver damage, loss of liver function, liver cancer, and death. Many F4c patients also experience clinically significant portal hypertension or CSPH, a major consequence of cirrhosis that's responsible for its most severe complications such as ascites, variceal bleeding, and hepatic encephalopathy. The risk of progression is striking. F2-F3 patients face a 10 to 17-fold increase in liver-related mortality compared to patients without fibrosis. For F4, that number jumps to a 42-fold increase. That's why we are evaluating Rezdiffra in 845 F4c patients in MAESTRO-NASH OUTCOMES, a large Phase 3 double-blind placebo-controlled trial evaluating progression to liver decompensation. We expect data from this trial in 2027. Last quarter we shared two-year data from the open label active treatment arm of our MAESTRO-NAFLD-1 trial in F4c patients. These results demonstrated Rezdiffra's ability to reduce liver stiffness, a key predictor of adverse liver-related events. Turning to slide nine, let me quickly recap the two primary efficacy findings. Patients saw a mean reduction of 6.7 kilopascals in liver stiffness at two years, which was statistically significant as compared to baseline. For context, physicians used the Bavino rule of 5 to stratify risk in MASH cirrhosis, so a 6.7 kPa reduction suggests that many patients are moving into a lower risk category. 51% of patients achieved a greater than or equal to 25% reduction in liver stiffness. As published in JAMA, this level of reduction is associated with a lower risk of progression to end-stage liver disease, essentially a reversal of cirrhosis. These results and additional insights will be presented at the upcoming EASL Congress on May 10 by Dr. Naim Alkhouri, Chief Academic Officer at Summit Clinical Research and the Director of the Steatotic Liver Disease Program at the Clinical Research Institute of Ohio. This abstract was accepted as a late-breaking oral presentation and one of the most important findings we'll highlight is Rezdiffra's impact to reduce liver stiffness measures and other biomarkers that are linked to a reduction in risk of CSPH. Importantly, CSPH is the cause of many adverse liver-related outcomes that mark the progression from compensated to decompensated cirrhosis. Preventing these devastating outcomes is the central goal of treating liver disease. As I mentioned earlier, we'll also be hosting a brief investor webcast on May 13 to review the data and discuss the evolving MASH cirrhosis landscape. Dr. Alkhouri will join us for that discussion, and we hope many of you will tune in. The expansion to treatment of F4c is a key pillar of our long-term MASH leadership strategy, as shown on slide 10. While we continue to execute a successful US launch in F2-F3, we're advancing efforts to expand Rezdiffra's indication to F4c. Our Phase 3 MAESTRO-NASH OUTCOMES trial is in alignment with FDA guidance for clinical trial design in cirrhosis patients. We expect to have data years ahead of the competition and first-mover advantage in this segment of the market as well. If approved, this could potentially double Rezdiffra's market opportunity. We're also preparing to bring Rezdiffra to patients outside the US. We remain on track for a mid-year regulatory decision in Europe. And if we receive a positive outcome, we plan to launch in Germany in the second half of the year. Beyond Europe, we're evaluating additional high-priority global markets. At the same time, we're focused on building the right pipeline beyond Rezdiffra. We're in the enviable position of delivering a first-in-disease medicine to patients today. And now we're looking to extend that leadership with a portfolio of differentiated assets. We're actively evaluating opportunities across multiple mechanisms and stages of development. And as I mentioned earlier, we're excited to have Dave Soergel on Board as our new Chief Medical Officer to help lead our pipeline development efforts. With that, let me briefly recap our first quarter progress on slide 11. We're off to a great start in year two of our launch. We generated $317 million in net sales over the last 12 months and are seeing continued momentum into the second quarter. Physician adoption continues to build with 70% of our 6,000 top targets now prescribing Rezdiffra. We're expanding our leadership in MASH with compelling two-year F4c data, two pivotal outcome trials underway and a potential EMA approval on the horizon, we believe Rezdiffra is well on its way to becoming the foundational therapy across F2 to F4c period.

Yes. Thank you, Bill and good morning. I want to highlight how Madrigal is doing in the current macroeconomic landscape. We are in a strong position as a commercial stage biotech with a first-in-class medicine addressing a significant unmet need, supported by a US-based supply chain. Rezdiffra is manufactured in the US and its intellectual property is also based there. Regarding our financial results, for the first quarter of 2025, net sales reached $137.3 million, which is a 33% increase from the fourth quarter of 2024. This quarter showed strong demand, with inventory levels within our anticipated two to four weeks. As previously mentioned, we expect some variability in gross to net during the early stages of the launch, and the team managed the first quarter well. In 2025, we anticipate the gross to net discount will rise and intensify throughout the year as we start contracting with payers, aligning with our expectations. This is already reflected in our projected strong year-over-year net sales growth in 2025. Research and development expenses for the first quarter of 2025 were $44.2 million, down from $71.2 million in the first quarter of 2024. This reduction was mainly due to changes in accounting for inventory costs after FDA approval of Rezdiffra in March 2024 and lower clinical trial expenses. Looking forward, we expect R&D spending to remain similar in 2025 compared to 2024. Selling, general and administrative expenses for the first quarter of 2025 were $167.9 million, an increase from $80.8 million in the first quarter of 2024. This rise of $87.1 million was primarily due to increased activities related to the commercial launch of Rezdiffra, which included a rise in headcount and stock compensation expenses. We anticipate SG&A expenses will continue to grow in 2025, particularly heading into the second quarter as we invest in the US launch and prepare for our launch in Europe. On our balance sheet, we finished the first quarter of 2025 with $848.1 million in cash, cash equivalents, restricted cash, and marketable securities. With this robust cash position, we are well-equipped to support the ongoing launch of Rezdiffra in the US and our planned launch in Europe in the latter half of this year.

Thanks, Mardi. Let's move into the Q&A portion of the call. Tawana, please go ahead and provide instructions for the Q&A session.

Hey guys, thanks for taking the question and congratulations on the quarter. Just curious to go a little bit more in depth on your expectations for the growth trajectory for Rezdiffra, particularly when sema's label is expanded to include MASH. Do you expect to see new patients at a similar rate? And can you just elaborate on sort of how you see the growth from there? Thanks.

Eli, thanks. Yeah. It was a great quarter. We're really excited about it. And as we said, we've continued that momentum into Q2. As we look towards the potential approval of sema, as we pointed out on one of the slides here, we have a couple of different views of how the market is going to evolve. Clearly, they're talking about a market which is multiples the size of our 315,000 patients. Our efforts to date have really been focused on the 315,000. So, there's plenty of patients when you consider where they're at about 5% penetration today. So, we see really years of growth in this market ahead. Sema is only going to accelerate diagnosis and add to that 315. As I said, our efforts are around the 315. We believe there's a great market there. There's even a greater market if what they do happens, which makes, as I said, multiples of the 315. So, a long way of saying, we feel really comfortable with our profile. We believe ours is the winning profile, and we believe that we can grow through their potential approval and launch.

Yeah. And maybe, Eli, I'll jump in here and just add a little bit. As Bill said, we expect this momentum of growth to continue into Q2. So, we do expect good quarter-over-quarter growth and also the same for 2025, robust growth for 2025. And I would just give the commentary here for both the quarter and for the year, we expect consensus to narrow and move up a little bit.

Thanks, Bill. Thanks, Mardi. Next question, please.

Hi, everyone. Good morning and congratulations on the quarter. Bill, could you just talk us through your expectations around payer reauthorization requirements that you might be seeing right now? And how are you thinking about the persistency of these patients to continue on Rezdiffra beyond this first year? Thanks so much.

Thanks, Andrea. So, reauthorizations are part of the process for every medicine. So, we're not really concerned about that. Most of the policies require a 12-month reauthorization, and that's in line with most drugs. Typically, it ends up being at kind of provider discretion or requires stabilization or some kind of measure on one of the NITs. So, we don't see that as an issue, specifically because we're hearing such great results from physicians and patients that have been on the drug. In fact, I said a lot of products when they launch, they typically don't live up to the well-controlled clinical trial environment that may show a certain level of efficacy. They end up declining a little bit. We're seeing absolutely the opposite in our case. We have physicians and patients coming back and saying, we're really seeing efficacy across a bunch of parameters and exceeding expectations in that sense, which leads to the persistency piece, which is because it's a well-tolerated oral, we would expect persistency to be very good like other well-tolerated orals. So, we feel we're in a really great spot because of the profile of the product and what the one-year results are of seeing such strong real-world experience.

Great. Thanks, Andrea. Tawana, next question please.

Good morning, everyone. Thank you for the question and congratulations on this quarter. My inquiry relates to Europe. I understand you are making progress with the CHMP documents as they are released. Could you update me on your response to their inquiries? I believe you requested an extension of the review period. What is the reason for needing additional time to respond? Also, as you continue discussions regarding the Rezdiffra label, could you explain how Europe's approach to non-invasive testing differs from the FDA's? It appears they might be moving towards accelerated acceptance. Does this influence the label that Rezdiffra may receive in Europe? Thank you.

Okay, Ritu, that's a lot to cover. I'll do my best to remember everything. The questions we're receiving are all anticipated. We're still on schedule for our mid-year actions. It's important to note that this is the first MASH product ever approved in Europe, and agencies are taking their time to ensure they understand everything and create the best possible label, which will serve as the basis for all future MASH labels. We're very pleased with the progress of the review. As I mentioned, we expect approval and plan to launch later this year. Regarding NITs, it's interesting to note that Europe had over a year to adapt to the idea of a MASH product. As we discussed last year, physicians in the US were somewhat skeptical about the possibility of approval due to the numerous failures before us. Conversely, with the US approval, Europe now has greater certainty. The steps they've taken since last year's EASL guidelines are actually quite advanced compared to the US. From an NIT standpoint, we believe there are sufficient installed NITs for us to launch effectively. However, similar to the US, additional NITs will need to be introduced as we launch the new product, and we need to rethink how we diagnose and stage patients accordingly. In many respects, the EU is ahead of the US in this regard, which we believe is crucial at this moment. We have EASL next week, and we're excited to engage directly with many physicians and gather their feedback on how their preparations are going. I was impressed last year, and I'm confident they're even further along now, which is what our teams are currently indicating.

Thank you.

Great. Thanks, Ritu. Next question, please.

Hey, thanks so much. Can you talk about your relative confidence in showing an outcomes benefit on hepatic events in F2-F3 versus F4? We're digging this internally, and there's some clear encouraging signals, whether it's the INTERCEPT trial or even Sema in F2-F3, there's almost no correlation we're seeing in F4 between liver fat reduction and actual hepatic events. So, what gives your team confidence the liver stiffness data will actually translate? I really appreciate it.

Thanks for the question. Nice to hear from you. Look, I think that as we showed in the slides today, the 6.7 kPa reduction at two years, we think, is actually quite meaningful. I think the literature supports that. But if we take even a step back further, mechanistically, our MOA, a liver-directed therapy. It's really looked at as kind of the master regulator of fibrosis. And we believe that starting from that point, we have great confidence in the mechanism. Now the data to date with the reduction in liver stiffness in this cohort of patients and we're going to explain more about it next week. I would encourage you to listen in. It gives us further confidence that, that is getting at the heart of the problem, and therefore, we won't have the events that you would without treatment. So, I think everything from the biology to what we've seen early gives us great confidence in our F4c trial that's ongoing that. We have 845 patients. It's a well-sized trial. And we're more encouraged, as I said, by the data that we've talked about today, and we're going to talk about at EASL next week. So yeah, look, like anything else, that's why you do the trials, right? And we'll have to see what results ultimately look like. But so far, we remain extremely confident in the outcome.

Great. Thanks, Akash. Next question, please.

Good morning, team. Congrats on a great quarter. My question is just now that you've had patients for over a year on therapy, have you been able to quantify sort of what the compliance rate is, and sort of as patients are kind of talking like do they feel function better as they're on the drug? So, what is the adherence rate that you're seeing? And how do you think it will be projected moving forward? And I'll jump back in the queue.

Thank you for the question. It's a bit early to determine what adherence will ultimately look like. However, early indications are quite encouraging. This ties back to how well the product is tolerated and its overall profile. One concern people have had regarding this asymptomatic disease is why someone would continue the treatment. Physicians have provided very positive feedback to patients, as they are observing beneficial results across various parameters. This gives patients a compelling reason to stick with the treatment, especially since most are not experiencing significant tolerability issues. We've spoken to many patients, and anecdotally, some are reporting that they feel an improvement. There's a sense of hope among them due to the risks associated with severe liver disease, especially since some have relatives who have undergone transplants or succumbed to MASH. I didn’t expect this to resonate as strongly, but the optimism stemming from having a once-daily pill is surprisingly powerful and contributes to their motivation to continue. We're feeling very positive about this. While it's still early, all indications suggest that we will achieve an adherence rate comparable to that of well-tolerated oral medications.

Great. Thanks so much, Yas. Next question, please.

Hi, thank you for the question and congratulations on a strong quarter. I would like to get more details on two topics. First, could you provide additional information on gross to net for the quarter? Also, regarding the trajectory moving forward, I understand it might fluctuate a bit, but I'm interested in more specific insights. Additionally, concerning GLP-1s, what percentage of your patients are currently using them? How do you anticipate this changing as semaglutide receives label expansion into MASH? Do you foresee any payers starting to favor this as it becomes available later this year? Thank you.

Thank you, Liisa. I have a couple of questions that I believe are on people's minds, so let's address those. To start with the GLP-1 combination, we previously reported that around 25% of patients using Rezdiffra are on a GLP-1, and this increases to about 50% for those who have had prior exposure. GLP-1s have been available for over a decade, yet there remains a significant challenge with MASH as patients are still being diagnosed and progressing. Regarding the potential for a step-through process, it's still early and we need to see the final approval and labeling. However, we have prepared for all possible scenarios and are confident in our ability to grow regardless of the circumstances. This confidence stems from the high unmet needs, along with our strong product profile as a liver-directed, once-a-day pill, which I have referred to as the ideal profile. Ultimately, adherence to medication is crucial; studies are great, but patients need to take the medication for it to be effective, and we believe we are in an excellent position. From a gross to net perspective, we have been very careful. As I've mentioned since the beginning, we have planned for the long term, considering the changing landscape and new market entrants. We started with a strong position by avoiding extensive contracting due to the innovative nature of our product. While the market dynamics can't be ignored, as payers continuously assess changes, we have looked ahead and anticipated competition. We have also established good partnerships with payers, which we intend to maintain. We began contracting in Q2, but it won't happen everywhere at once; it's a gradual process. We are currently on track with our plans for the short, medium, and long term and feel strong about our position. Mardi, could you elaborate a bit on the gross to net dynamics for 2025?

I'm happy to share. As Bill mentioned, we've been very disciplined with our gross to net, and this will remain a key aspect of our business going forward. It's still somewhat unpredictable, which will continue as we launch new products. Our team did an excellent job transitioning from the fourth quarter to the first quarter and managing the various dynamics effectively. For Q1, we are slightly better than expected across the board for gross to net, while staying within the usual range for specialty pharmacy products. As we noted last quarter, we anticipate this will gradually improve throughout 2025, particularly with some of the contracting, although it's not happening everywhere or all at once. As these changes take effect throughout the year, we're in a very positive position with our gross to net, aligning well with our expectations moving forward.

Great. Thanks, Liisa for the question. Next question, please.

Hey, congrats on the impressive launch progress and thanks to Becky for her pioneering efforts successfully bringing Rezdiffra to market. Can you talk about any feedback on the key messages in your DTC campaign, and how that's impacted the launch trajectory? And then with regards to business development, as you look ahead to extending your leadership position in MASH, what sort of complementary assets would you like to add to Rezdiffra?

Great. Jay, thank you for your question. Firstly, regarding direct-to-consumer, the feedback has been very positive. Our aim is to reach primarily diagnosed patients and ensure they are ready to take action when they visit their healthcare provider. The feedback from the community has been strong, and we are encouraged by this response. This initiative is vital because many people are not well-informed about the disease. The major challenge we face is prompting action. We frequently hear heartbreaking stories of patients whose doctors have not taken action or who were unaware of what fatty liver disease entailed, only to return years later to discover they need a transplant. As a company, our mission is to lead the fight against MASH, and we take that responsibility seriously. Education through direct-to-consumer efforts is crucial. As our DTC campaign continues to develop, I encourage you to visit our new website, defusedmash.com, which emphasizes the seriousness of this disease and the need for action. As for your second question about business development, we have made our position clear. We are fortunate to find ourselves in a unique situation. While most companies are seeking great assets for their pipelines, we already have a strong asset and the opportunity to build a pipeline to maintain our leadership. Rarely does one find themselves in this position in the industry, being the first to launch a solution for a challenging disease that has faced development difficulties. We are the pioneers in this field with a product tailored to the problem. However, it’s essential for us to have additional products to extend our leadership. Our focus will be on MASH, and we are exploring new mechanisms of action that are promising or products that could enhance Rezdiffra’s effectiveness. This could help us improve efficacy, reach different patient populations, and more. We are evaluating the entire pipeline, from early to late stages, based on mechanisms we find interesting and beneficial for patients. We will approach partnerships with care, ensuring we maintain financial discipline and make impactful deals that will benefit patients while fortifying our future leadership. We will provide more updates when we have information to share.

Thanks, Jay. Next question, please.

Good morning, team. Thank you for addressing our questions and congratulations on a strong quarter. In reviewing Novo's New England publication from last night regarding ESSENCE, it appears that the benefit from semaglutide is occurring interestingly in low to mid BMI F2 patients rather than in the more advanced F3 patients. I would like to hear your thoughts on how you might be approaching patient segmentation. Your benefit seems more significant in the advanced F3-F4 category. Also, regarding the EU approval launch strategy mid-year, I'm curious about the implications of the F4 data that will be presented at EASL, especially in relation to pricing considering the current discussions about innovations potentially receiving better recognition in EU countries. Thank you once more for your responses.

Thank you for the question. We didn't see anything new; we received the information last night like everyone else. We're reviewing it, but there's really nothing new to report. In a well-controlled trial, you obtain specific results, but the real issue is how these results apply in real-world settings. In practice, GLP-1s face challenges, particularly in maintaining patient adherence and achieving the highest doses. Our perspective on this news hasn't changed. Currently, we're seeing roughly a 50-50 mix of F2 and F3 patients. When a patient visits their physician every six or twelve months, the physician assesses the patient at that point in time. If a patient is marked as F2, the physician might decide to wait a year; during that time, the patient's condition could progress to F3 or beyond. This is why physicians often opt to treat patients regardless of whether they are classified as F2 or F3. We anticipate this mix will continue. We also hope to expand into the F4c category, and we believe we can be the product that transitions patients from F2 to F4c, which is an ambitious yet achievable goal. I'm confident in our positioning and our product profile. Regarding our strategy in Europe and pricing, we are currently conducting a pricing analysis. We believe our product is highly innovative and that this will be acknowledged in Europe. Many patients, particularly those with MASH, have already been exposed to GLP-1s; around 50% of our patients fall into this category. We expect that both treatments can coexist, and we will focus on those patients who require liver-directed therapy. There's significant potential for us within the GLP-1 segment as we are just at the start of this market. Based on my experience, when new entrants join a market, it usually results in substantial market growth, which is clearly a goal for Novo. Consequently, there will be numerous patients available to us, regardless of how the market dynamics change.

Thanks, Mayank. Next question, please.

Hi. Thank you so much for taking my questions and congratulations on the strong quarter. So, I had a couple. A follow-up on gross to net as well, but maybe longer term for 2026 and beyond, as you are having the initial payer contracting discussions for next year. What do you expect in terms of the net pricing evolution for 2026? Do you expect a big step-up compared to 2025 given the sema launch? And just curious as to what you're hearing from the payers, especially given the pricing differential. And secondly, maybe quickly on BD, clearly seems to be a priority, but what exactly is the BD capacity given the ongoing investments in the launch in the US and later Europe? Thank you so much.

All right. Thanks for the question. Maybe I'll start with just a comment on gross to net and then Mardi can provide a little bit more. I mean, look, as I said, you heard me answer earlier, we've taken a long-term view of gross to net. We know with pretty good certainty what the potential market evolution looks like with new entrants, just looking at the pipeline and so forth. It's a little early to comment on '26. Gross to net only goes in one direction. And we've been very disciplined about it. We'll continue to be. We have a very significant value proposition with the product that we have. So, we think that we'll continue to be in a very favorable place from a gross to net perspective. But maybe, Mardi, do you want to comment any more on that or it's still early?

Yeah. It's really too early, Prakhar, so on 2026, but it's all part of our business and it's all part of our expectations. We have ongoing dialogue and good relationships with the payers and we'll talk about that more as the year progresses.

And then regarding BD, as I said, we're not doing a bet-the-company strategy. We're going to be very, very diligent and disciplined about the way we do deals. And Mardi, do you want to comment?

You mentioned capacity, and I agree with Bill's point. We're not risking the entire company. Our cash position is strong, and we are concentrating on expanding our operations in the US and internationally. If we pursue business development, that could impact our cash flow differently. However, at this moment, our cash situation is very favorable.

Thanks. Tawana, it looks like we have time for one more question, please.

Hi, this is Emma on for Andy. Thanks for taking our question and congrats on the quarter you mentioned. You mentioned six abstracts will be presented at EASL next week. I guess, just aside from the late breaker, which is more focused on the F4c data, what are other key findings to look out for? Thank you.

We are excited to present significant data at the upcoming meeting, particularly related to FGF21s in F4c, which has garnered interest. The late breaker will showcase impressive findings, along with six different posters covering a wide range of topics, from addressing unmet needs to detailed results from our claims analysis in Germany. This data will provide insights into the severity of the disease and real-world incidence rates of conditions like HCC. We're looking forward to engaging with the global physician community and have heard there is great anticipation for the discussions we will have. The late breaker is highly anticipated, so stay tuned for updates, and we hope to see many of you at the event as well as on our call discussing the F4c data after EASL.

Great. Emma, thanks for that question. And Tawana, thanks for your time, and thank you all for your interest today. This is now the time we're going to conclude the call. A replay of this webcast will be available on our website in approximately two hours. So, thank you so much for joining us.

That concludes today's conference call. Thank you for your participation. You may now disconnect.