Novartis AG (NVS) Q4 2025 Earnings Call Transcript

Good morning, and good afternoon, and welcome to the Novartis Q4 Full Year 2025 Results Release Conference Call and Live Webcast. Please note that during the presentation, all participants will be in listen-only mode, and the conference is being recorded. After the presentation, there will be an opportunity to ask questions by pressing star 1 and 1 at any time during the conference. Please limit yourself to one question and return to the queue for any follow-ups. A recording of the conference call, including the Q&A session, will be available on our website shortly after the call ends. With that, I would like to hand over to Ms. Sloane Simpson, Head of Investor Relations. Please go ahead, Madam.

Thank you, Sarah. Good morning and good afternoon, everyone, and welcome to our Q4 2025 earnings call. The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties, and other factors. These may cause actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. Please refer to the company's Form 20-F on file with the U.S. Securities and Exchange Commission for a description of some of these factors. The discussion today is not a solicitation of a proxy nor an offer of any kind with respect to the securities of Avidity Biosciences or SPINCO. The parties have filed relevant documents with the U.S. SEC, including a proxy statement for the transactions and a registration statement for the spinoff. We urge you to read these materials that contain important information when they become available. Before we get started, I also want to remind our analysts to please limit yourselves to one question at a time, and we'll cycle through the queue as needed. With that, I will hand over to Beth.

Terrific. Thank you, Sloan, and great to be with everyone today. With me in the room are Harry Kirsch, our Chief Financial Officer, and Mukul Mehta, our Chief Financial Officer-designate, who will be taking over for Harry in mid-March. So let's dive into the results, and when we start on slide five, Novartis delivered high single-digit growth, as you saw earlier this morning, and importantly, we achieved our 40% core margin goal two years ahead of plan, and I think that demonstrates the strong operational performance of the company. On the full year, our sales were up 8%. Core Opink was up 14%. As I mentioned, the 40.1% core margin, $21.9 billion now on Core Opink, significant growth over the years. On quarter four, sales did decline, impacted by both the growth to nets, which we'll talk about a bit more, as well as the Entresto LOE. And Core Opink is up 1%. We did have some important pipeline highlights, which we'll cover over the course of the call, but I think there's a few I wanted to highlight up front. First, remibrutinib. We achieved the submission in the most common type of Sindhu that was based on positive phase three results as well as interactions with the FDA, and we'll have the remaining readouts for the two other subtypes of chronic inducible urticaria over the first half of this year. And with Colabrasiv, we now have a path forward for both the EU and the U.S. I'll go through that data and the path forward on a future slide. Overall, we met our upgraded full-year 2025 guidance. We expect to grow in 2026 through the largest patent expiry in Novartis history, which I think demonstrates the strong performance we have on our key growth brands as well as our pipeline replacement power. Moving to slide six, the growth drivers in the quarter continue their strong trajectory, as well as on the full year. Here you see the full year numbers. You can see Cascali was up 57% on the full year. Kasimta was up 36%. Semblix up 85%. Suvicto on the PSMA 4 launch having dynamic growth as well. We'll talk about each of these brands in turn. Overall, 35% growth in this portfolio. And this is the portfolio that will carry us through the end of the decade, as well as with many of these brands taking us into the mid-2030s. Now, moving to slide seven. On Quescally, we grew 57% on the year to $4.8 billion, outpacing the market for CDK4.6. Now, when you look at the chart on the lower left, our growth was 44% in Q4. When you remove the U.S. RD adjustments, our global sales grew at 54%, and our U.S. sales growth was at 62%. So, in our view versus the consensus, the entire miss really came from these one-time RD adjustments. We remain fully confident on the $10 billion peak sales outlook for the brand. And what's underpinning that confidence is the very strong volume growth we're seeing across geographies. When you look at the middle panel, U.S., EBC, NBRX is now above 60% and holding steady. I think that really demonstrates the strong preference providers have for Kiskali, particularly in settings where we are uniquely positioned. And in Germany, we have over 80% in BRX share in the early breast cancer setting, which I think shows, again, this early strong performance for the launch in Germany, which we hope to carry over now to other ex-US markets. So, going to the last panel, I already went through many of the key elements, but I think I wanted to also note that EBC NBRX share is leading in both the overlapping and the exclusive population. Outside of the U.S., we have important launches in Italy and Spain coming up in 2026. And finally, we continue to bolster the data profile for Kisgali, both with data that we recently presented at San Antonio and Esmo. We'll continue to follow up these patients over the long run, and that should allow us to continue to have mature OS data over time, which we think will continue to bolster the portfolio. So very excited. Kisgali continues to have the outlook to be the largest brand in Novartis' history. Now moving to slide eight. Casenta grew 36% to $4.4 billion on the year. You can see a continued steady performance of this brand, driven by the continued expansion of the B-cell class within MS. In the U.S., we had 27% growth in quarter four. Importantly, we see increasing adoption in naive patients, which are now 50% of our NBRXs now in first line. Outside of the U.S., we are leading now in NBRX share on 9 out of 10 of the major markets that we track. And the core opportunity we see ex-US going forward is to continue to expand B-cell therapies in the 67% of patients who are not on B-cell therapies and receiving disease-modifying therapies in MMS. So, we continue to generate additional value for Kesemta. We continue to progress also our every two-month formulation for Kesemta. So, I think we're on a solid track with this brand to fully achieve our peak sales guidance of $6 billion plus. Now, moving to the next slide. So, Victo now really showing dynamic performance with the PSMA4 launch, 42% constant currency growth. We reached $2 billion in sales now overall globally. And that strong performance was driven primarily in the U.S., where we continue to see strong uptake in the pre-taxing setting. Sales grew 75%. We saw a 4x increase in our PSMA share since approval, now reaching 16% in that setting. We also see continued growth across provider settings, including the highest growth in community, where we now have over 790 treatment sites. Outside of the U.S., importantly, we've secured approvals in Japan and China, which also allowed us to continue to drive that ex-U.S. strong growth, and we expect that growth to accelerate now with the Japan and China launches upcoming. Now, the next phase for Pluvicto, as we expect to kind of get to the peak of the PSMA-4 population over the course of this year, will be the launch in the hormone-sensitive setting, which adds about 75% additional patients to the patients we already have from the vision and PSMA-4 population. That SNDA has been submitted to the FDA, as well as the NMPA in China and PMDA in Japan. We have the right foundation for that launch to be, we think, a rapid uptake with two-thirds of eligible hormone-sensitive patients already with existing treaters or providers. So, the capacity is well-established. I did want to flag as well that we have new manufacturing sites that are coming online in California, in Florida, as well as in Japan and China. We have over 440 treatment sites now outside of the U.S. as well. So, we've really taken this to scale, which positions us well for the Plavicta launches, ongoing Ludathera business, as well as our future RLT portfolio. Now, moving to slide 10. Lectio reached blockbuster status in the quarter, an important milestone for this brand as we continue that steady trajectory that we often see for cardiovascular launches, 57% growth on the full year, 46% on the quarter. In the U.S., we continue to outpace the overall advanced lipid lowering market, and our real focus is increasing depth in the health systems we've prioritized where there's strong capabilities within the buy-and-build setting, strong interest in getting patients to goal, also focusing more on specialty areas as we've guided in the past. We saw 33% growth in the setting versus the prior year. Now, a key milestone for us outside of the U.S. will be the NRDL listing, which we achieved in China and is now already now started in the first part of January. As you have heard on previous calls, we have had very strong uptake in China in the private setting. And now with the NRDL listing, the early signals are very strong for rapid uptake in the China market for Lectio. So we're quite excited about that, and it's a key focus area for us in 2026. We continue to build the evidence base for Lecquio, important publications in various journals, mostly focused on adherence rates, as well as our ability to drive LDL-C down to goal, regardless of which background therapy patients are on. Now, moving to slide 11. Semblix had another strong quarter. We've reached, again, blockbuster status with this brand, and we have NBRX leadership in the U.S. and Japan, 87% growth in Q4. Now, if I could focus your attention on the middle panel, in the U.S., we've reached 41% NBRX share now across all lines of therapy, and we plan to continue to grow that. But the most important thing for us now is to drive the growth in the first-line setting where we're trending ahead of our plan. We're already now in the mid-20% range in the frontline setting. We want to drive that up. And I think as we've now secured broad access, we have the opportunity now to continue to make Semlis the medicine of choice on the frontline for patients with TML. And now, outside of the U.S., we also continue to have our leadership in the third-line setting with 72 percent share across the major markets that we track. The early-line indication is now approved in 60 countries, and we've already just launched in Germany, and we expect to get other EU markets online in the front line with launches expected in 2027. I think one ex-U.S. market to note, which I think shows the ability we have to drive assemblates outside of the U.S., is in Japan, where we already have 45% front-line market share, NBRX share, and 74% second-line NBRX share. So, really strong outlook, confident in the $4 billion-plus outlook for this medicine. Now, moving to slide 12. Cosmetics grew 8% overall in the year, getting to $6.7 billion. On the steady march up to our $8 billion peak sales guidance, you can see the 11% growth on the quarter. In the U.S., we had 9% growth. That was driven by a higher demand we saw both in hydro adenitis and in IV. Right now, we're the number one prescribed IL-17 across indications, and that's really because of the strong access that we have, frontline access. NHS now, we're the NBRX leader in naive patients with 51% share and 47% overall. And, you know, the naive market is two and a half times the switch market. Certainly, we've seen our competitor get traction in the switch market, but we're very much focused in that naive market where we have a really strong position. And the IV is also steadily advancing, 8%, steady growth, 200 new accounts. We expect that to continue over the coming years. Outside of the U.S., no major changes, continued very strong growth, leading originator biologic in the EU and China. And overall, we would forecast Cosentix to have, on average, mid-single-digit growth over the coming years as we get to that $8 billion peak sales potential. I did want to also flag that we have completed the submission with the U.S. FDA for polymyalgia rheumatica, and so we're excited about that as an additional launch now for Chrysantix, and we're also on track to file in the EU and Japan in the first half. The movement is slide 13. Our renal portfolio has continued its rollout, I think, with steady progress. And separate from that, we also have amended our Zika-Kaibar phase three protocol, which I wanted to talk about in a bit more detail. Starting with our renal portfolio, our IGAM portfolio contributed 50% of the NBRX market growth for its prior year, driven equally by Van Raffia and Pupulsa. So I think we see steady uptake across these two brands. Also, in C3G, FabHalta continued steady adoption across the top accounts, and we hope to see that accelerate now over the course of 2026. And outside of the U.S., FabHalta is now approved in C3G in 45 countries. VanRafia had its EU submission. So I think across these three brands, we have the opportunity to continue to build out a strong position. We do expect to be able to provide the full data set on the Fabhalta EGFR readout in IGAN soon, and also move forward with the filing for full approval in IGAN for Fabhalta. And we also expect, I should also note, the VADRAFIA full EGFR data set in the first half. On Zika-Kaibar, we have made the decision in order to optimize the overall label positioning and the competitive positioning to align our UPCR readout with the interim EGFR readout, which we expect in the first half of 2027, and we expect that to support our BLA for a full approval. This was a decision based on an analysis of the phase one and two data. We think we have the opportunity to be second to market with both proteinuria and the EGFR benefit. And so that, I think, is going to hopefully position us well to have a fourth renal agent in our portfolio. We also have combination trials underway because we certainly see the opportunity in having a hemodynamic agent, having a fibhalter, and having a Zika-Kybar, the opportunity to use combinations to optimize care for these patients. Now, moving to slide 14. Rapsida is a U.S. launch, which is obviously something we're very closely tracking. It's delivering encouraging results. We are optimistic with already what we're seeing in the early days for this launch. We see strong demand with an encouraging mix of patients, both patients who are post-antihistamines as well as post-biologic failure. We have a strong and positive response from allergists and dermatologists. The sampling and bridge program has over 2,000 HCP starts, and I think that when we benchmark that versus other highly successful dermatology launches, it's right in line with some of the most successful dermatology launches. We're also seeing early access wins. I think access will be now the gating factor. Every few months, we expect to bring on additional access on board. That will allow a steady pickup in sales over the course of the year, with more of a steady pickup in the second half of the year. I think for that second half, I would encourage everyone to watch as we get that access together. And as a reminder, I think you all know well, clean safety, no box warnings, no contraindication, no required routine lab monitoring, no liver safety issues in the label, fast relief across a broad population as fast as two weeks. Anecdotally, we hear reports as fast as a day or two days, patients are starting to see benefits. And it's the ordinary oral therapy approved by FDA who remains symptomatic despite antihistamine therapy. Now, moving to slide 15. Now, Rapsido is one of these brands that we hope over time can become one of the largest brands in Novartis' history. This is an opportunity over multiple indications. I mentioned CSU, a launch, Sindhu, now positive data that we have in hand for one type, two more types coming, an HS readout in 2028. We have positive food allergy data, which we'll be presenting in Q1 of this year, and that's leading us to now initiate a broad phase three program in food allergy. We are on track for the RMS readouts, second half of this year, but really mid of this year is the opportunity that we have to read out the two RMS studies, SDMS and Myasthenia Gravia, ongoing. So, when you take that together, you really clearly have an opportunity with a medicine with a clean safety profile and strong efficacy as an oral option to have a significant long-term sales potential. Now, moving to slide 16. Now, in Visma, which we haven't had as much attention, but it's something we continue to believe has a significant overall sales potential, total potential for this brand across the IV and IT of $3 billion plus. This is a U.S. approval that brings the one-time gene therapy to children's two years and older. It's a broad label across patients who are non-sitters, sitters, and walkers. No AAV9 antibody titer limit for this treatment. There's a strong value proposition, single administration, durable efficacy, solid safety profile. So we see a multi-blockbuster opportunity for this brand. 7,500 children, teens, and adults have not been treated yet with Zolgensma IV. We also have an extensive experience in the U.S. and ex-U.S. with this medicine. Outside of the U.S., we've already been approved in the UAE one day after the FDA approval, and Europe and Japan submissions are completed. And as a reminder, for Zolgensma, actually, our sales are larger outside of the U.S. than in the U.S., so there's certainly a significant opportunity ex-U.S. for Sysma. Now, moving to slide 17. As I mentioned in the first slide, collaborative, we read out in the quarter four the 96-week data from the Phase III Manifest Program, which both on safety and efficacy has now given us a path forward to, we believe, get this medicine registered, assuming successful regulatory and clinical trial Phase III trials. In that study, we showed deep and durable responses and a comparable safety profile to ruxolitinib and myelofibrosis. You can see the data here on the left in terms of the spleen response. When you look at the data that we presented, we had a deep and durable spleen volume reduction for the spleen volume, 35% reduction landmark, 91.5% versus 57.6%. We also saw sustained improvements in symptom scores and anemia. We had two times as many patients reaching goal with the spleen volume reduction and the TFS50. So we believe this medicine has disease-modifying potential. We saw improvements in bone marrow pathology on the anemia. There is importantly now from a mortality standpoint, fewer deaths and progressions observed with palabrasib and ruxolitinib versus ruxolitinib alone, and the overall safety now has proven comparable with ruxolitinib, including comparable leukemic transformation rates, which was one of the topics that was holding this program back. So, with this data set, we have now an agreement with the EU to file in 2026 based on this data, and in the U.S., China, and Japan, we'll be starting a new phase three study focused on patients who have high TSS 50 at baseline, where we believe we have the data set now to show we can achieve the regulatory milestone to ultimately get approval. Now, moving to slide 18. I did want to also take a moment to mention our impact on global health. As I think many of you know, Novartis has been in global health for nearly 100 years working on malaria and other neglected tropical diseases. With our CoARTEM medicine 25 years ago, we started a real sea change in the treatment of malaria, reaching now well over a billion patients with CoARTEM. And now, with the recent data we presented in November, we have the opportunity to bring the first new malaria medicine, novel medicine, so it's Coartem, in 25 years. This is KLU156, scannoplicide plus lumifantrine. It disrupts the parasite's internal protein system. Very positive data here you see on the adjusted basis, 99.2% cure rate versus 96.4% versus a five-day course, A three-day course, opportunity to block transmission, a very solid safety profile. So we're quite excited to bring this forward as part of our mission in global health. Moving to slide 19. Now, taken together, very good year for us from a pipeline standpoint in 2025. You can see we've met the vast majority of our milestones and trial starts, and I think that really shows the strong execution machinery we have now in R&D as a company, very aligned across research and development and strong execution across our global development organization. And turning to slide 20... For 2026, we're on track for seven pivotal readouts with the potential to strengthen the midterm outlook that we're guiding to, including the mid-single-digit sales growth we expect in the 2030s. A few particular readouts which I haven't mentioned, which I'll call out. On the left side, you can see Pella Carson for CVRR. We do expect a readout middle of this year. It will be second half, but it will be middle of this year, which, if positive, would allow us for a U.S. submission this year. We also are on track for our submissions for Yonalimab and Sjogren's disease, as well as the Delzoda DMD UF submission, which, assuming the closure of the Avidity deal, would also happen in the first half of this year. Number of pivotal readouts. I mentioned Paul Carson. There will be the Yonalimab readouts in hematology, which could have significant potential to drive that brand to very large long-term potential. Of course, remebrutinib, as well as the Deldiceran DM1 Phase 3 readout, again, assuming the closure of the avidity. We also have the additional readout of the Dux4 interim data readout as well, which could support accelerated launch in FSHD. However, that we would characterize as an upside case. And then a number of key study initiations you can see on the right-hand side of the chart. So another exciting pipeline year to continue to bolster our long-term growth profile. Now, moving to slide 21, I will hand it over now to Harry.

Yeah, thank you, Vaz. Good morning, good afternoon, everybody. I now walk you through our financial results for the fourth quarter and the full year of 2025, which, as Vaz mentioned, was very strong despite mid-year significant U.S. generic entries. And as always, my comments refer to growth rates in currencies unless otherwise noted. So on slide 22... 2025 marked another year of excellent execution. So over the last five years, as you can see here, we delivered an 8% sales average growth rate and a 15% core operating income average growth rate, driven by strong commercial execution. A great late stage readout and disciplined productivity programs. This translated on the right side into more than a thousand basis points of core margin expansion in constant currencies. And as you can see, reported currencies allowed us to reach our midterm core margin target of 40% two years earlier than planned. As you may recall, we initially planned for 2027. Now we have achieved it in 2025. With this result, I hope you agree, but I believe we have really elevated the company to a new level of sales performance, margin profile, and as I'll discuss later, pre-cash flow generation. On slide 23, just a quick summary. You see that we have delivered our full-year guidance in 2025 after upgrading twice throughout the year, and we guided to high single-digit sales growth, and we delivered 8%. For co-operating income, we guided to low teens and achieved 14%, and this is a strong result in the year, as I mentioned, where U.S. generic entries for Entresto, Promacta, and Tersigna happened, And it speaks really for the momentum of our priority brands, as Martha really laid out, as well as disciplined cost management. Turning to slide 24. So here are a few more details. For the full year, we delivered the described solid top and bottom line growth, record a core margin, and record free cash flow, almost $18 billion. The core margin in the year improved by 210 basic points to 40.1%, and core EPS rose 17% to $8.98. Free cash flow grew 8% to $17.6 billion. Now, for the quarter on the right side here, as expected, the U.S. generics had an impact, which we see in QOrder 4, and then Mukul will lay it out, first half of next year, or 2026, but then again back to growth. Anyway, sales declined 1%, whilst cooperating income increased by 1%. And the results were a little bit noisy due to some U.S. R.D. adjustments. A positive impact in quarter four of 2024, so last year financially, and a negative impact this year in quarter four 2025, mostly on generic brands. So excluding this adjustment, underlying quarter four sales growth would have been positive 3%. As said, the vast majority of the growth to net adjustments were Entresto and other generic brands like Promacta in the U.S. Core EPS in a quarter, $2.03, up 2%. Now on slide 25. You can see our continued progress on free cash flow generation, which reached $17.6 billion all-time high for the company in 2025. I think it shows you also, beside the financial, the power of being a pure-play pharma company. As you know, many years back with even six businesses or even before the Alcon and Sandospin, these numbers were usually the $10 to $12 billion range. And now, this is the earnings power of a focused and very successful pharma business. We remain, of course, focused on ensuring that a growth and co-operating income translates into high-quality earnings and strong cash flow generation. This robust cash flow allows us to reinvest in the business, pursue bolt-on acquisitions, and continue to return attractive capital to the shareholder through growing dividend and share buybacks. On page 26, a quick reminder on our unchanged capital allocation strategy. As you see, we continue to execute our balanced shareholder-friendly capital allocation in 2025. We invested more than $10 billion in R&D, an 8% increase for a year, announced four acquisitions, 10 licensing deals, strengthening our key platforms, and pipeline across all of our four therapeutic areas. On returning capital to our shareholders, we completed our $15 billion share price program in early July, and we launched a new up to $10 billion program, targeted to be completed by the end of 2027. Approximately $7.7 billion of that remains to be executed. In addition, we distributed $7.8 billion in dividends during the first half of 2025. Now, speaking of dividends... Turning to slide 27, we are proposing a dividend of 3.70 francs per share, a 6% increase in Swiss francs and even double digits in dollars. And it's our 29th consecutive dividend increase in Swiss francs since company creation 96. And including years following the Sandoz and Alcon spins when we did not rebase the dividend at all. This reflects our long-term and long-standing commitment to a growing dividend in Swiss francs per share. That concludes my remarks. Before handing over, I'd like to briefly acknowledge that this will be my final earnings call as CFO of Novartis. It has been a privilege to serve this role the last 13 years. And to work alongside VAS and so many other great colleagues to help guide the company through a period of significant transformation and performance improvement. I'm very pleased to hand over to Mukul, a longtime colleague. In fact, we both started maybe at different stages of our career in 2003 at Novartis and very intensively worked together, especially the last 10 years. So with that, I turn over to Mukul to take you through 2026 guidance.

A big thank you to you, Hari, for everything. It is an honor to step into the role that you're leaving me with, and I look forward to getting to know everybody on the line in the months to come. If you can go on slide number 29, please. For 2026, we expect sales to grow low single digits and core operating income to decline low single digits, and this reflects the 1% to 2% points of core margin dilution related to the average deal that we had previously indicated. Importantly, in 2026, we will be growing top lines through a period of highest GX impact in our company's history. At the same time, we will make sure that we continue to invest in R&D, we fund our launches appropriately, while driving forward with the productivity improvement plans that the company has. As previously noted, we expect to close the avidated yield in the first half of 2026. Looking ahead, we remain very confident in our 5% to 6% sales CAGR in the 25-30 period, and we expect to return to 40% plus core margin in 2029, as laid out in our capital market style. For 2026, we expect core net financial income expenses to be around $1.7 billion. This is higher than the 25 levels, and this is largely due to the anticipated funding costs related to the abidity deal, which we have previously indicated is primarily going to be debt funded. We also expect co-tax rate to remain around 16.5%. Moving to slide 30, please. As we have indicated as well, 2026 is going to be a year of two halves. We continue to expect strong volume growth from our priority plans throughout 2026. But we have to understand that for the first half of the year, we will have a tough prior year base with Interesto, ProMarket, and the Cigna generics having entered the U.S. market mid-2025. With that, we expect the first half of the year sales to decline low single digit and co-operating income to decline low double digit. Additionally, Q1 will be impacted by the 2% Positive gross net impact that we have in the base Q125, which will weigh on the quarter-on-quarter growth rate in Q1. That said, in the second half of the year, we expect a clear improvement, with sales growing mid-single digit and core operating income growing mid-to-high single digit. This takes us to our full-year guidance of low single digit on top line. Moving to slide 31, please. If exchange rates remain as at their late January levels, we expect a positive two to three percentage point impact on our full year sales and a positive one percent point impact on co-operating income. And as a reminder, which Harry has conveyed previously, we publish updated FX estimates monthly on our website. So that concludes my remarks, and I hand it over back to us.

Yeah, thank you, Mikul. I want to take a moment as well to acknowledge Harry Kirsch's incredible contributions to Novartis over 23 years. Over my tenure as CEO, now entering my ninth year, Harry's been by my side as we've transformed the company to a pure play, and I think unlocked really outstanding shareholder returns, outstanding financial performance. But probably less visible is the strength of the finance organization Harry's built, as well as the culture he's created in the company around productivity, financial discipline, and operational excellence. He'll sorely be missed, but will continue his legacy in the years to come. And a big welcome to McCool, who I've known for many, many years. He'll be a great addition to the team and continue the strong track record of Novartis Finance in delivering strong operational execution. Now, moving to the next slide, I do want to take a moment to build on Mikul's comments on our confidence in our 5% to 6% sales trigger to 25% to 30%. That includes the impact of Entresto in 2026, as well as the U.S. MFN agreement's impact. You can see in the chart, we do expect some generic impact, so a lot of that is front-loaded in the early part of the five-year trajectory here. A number of brands where we believe we can drive dynamic growth in the middle column. And then lastly, a strong set of athletes that we've probabilized in our pipeline. This ranges from Yonalimab, our various Pluvicto, and Actinium, PSMA, Pellicarsin, as well as the Avidity assets amongst others that give us the opportunity to not only hopefully deliver the 5% to 6%, But if we're successful on those pipeline assets, we could even drive higher growth in the period. Moving to slide 34, and in closing, strong performance in 2025. We delivered the guidance that we outlooked and got to our 40% core margin early. Our priority brands continue to outperform, and that's what's going to drive our growth through the second half of 26 and then through the five years to come. We're advancing the pipeline meaningfully in 2020. We advanced it meaningfully in 2025, but seven pivotal readouts this year. And we're confident in that mid- to long-term growth guidance. So, with that, we can close this section and move to questions. So, operator, we can open the line. Thank you.

Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. And to withdraw your question, please press star one and one again. Please stand by while we compile the Q&A roster. Thank you. We'll start with our first question, and this is from Sash and Jane from Bank of America. Please go ahead.

Hi there. Thanks for taking my questions, and perhaps I'll just kick off with thanking Harrod for his support and insight over the years. The questions, I guess, will add on Remy. You talked about avoiding liver monitoring in MS, given no high's law. Competition recently has been vocal at avoiding monitoring in the label. When monitoring has been involved in the studies, it could be difficult. So why don't you just give us any colour on FDA conversations around this topic? And where the monitoring of studies picks up events that require dose changes. And then a quick follow-on on efficacy, any color on what you're targeting on relapse or a progression given we have no phase two to go off here.

Yeah, thanks, Sachin. So, I think first on liver, I think we should first take a step back and note that we already have an approval and an approved label without any liver safety discussion in the label, which just points to the fact that remybrudinib structurally does not have the off-target toxicities we believe that the structures of some of the other molecules do, and so that we didn't have any of that in the existing CSU label. I think I have an abundance of caution given the findings of the other competitors. FDA asked us for limited liver monitoring to our understanding that's more limited than the liver monitoring that our competitors have had to add to their programs. And our full plan is assuming that we – and as we've seen today, no liver signals in our study. We fully plan to advocate to FDA that we should stick to the current label and in the absence of any information to really – any data to really change the current label with respect to that. You might also note that for, you know, in general, for competitors, when there is a Heislaw case, at least to our understanding, whether it's one, two, three cases, That generally leads to REMS programs, leads to monitoring, does lead to warnings and precautions, just given the safety risk that that creates for patients who have alternative therapies. And in RRMS, there's numerous alternative therapies, so safety is absolutely paramount. So I think that's our overall perspective on the safety. We're very confident in overall Remy's safety, and assuming two positive Phase III trials this summer, the potential for this to be a very significant medicine. Now, with respect to efficacy, I think it's very fair to point out we don't have phase two data. We went to phase three based on the findings that we saw from competitors. But I think given that we know that we hit the target very well at 25 milligrams BID, and we move up to 120 milligrams BID in the study, we think we'll definitely have strong target saturation. We think the molecule is very well designed. We look at the PK and the PD of the molecule. So that gives us confidence that assuming the class is effective against RMS, we will have a compelling profile from an efficacy standpoint, and with the safety profile and with the fact that we're established now in the market having already launched should give us a strong value proposition. Thanks, Dustin. Next question. Thank you.

Thank you. We'll take our next question today, and this is from Simon Baker, Rothschild and co-Rithburn. Please go ahead.

Thank you for taking my questions. Kira, if I may, please. Firstly, just continuing on remebrutinib. I'd go off on Sutton's question. I just wondered if you could give us your updated thoughts on the commercial opportunities here in MS, because it – It kind of feels like that your enthusiasm for Remy in MS has increased over time, that a couple of years ago there was talk of almost MS being sort of playing second fiddle to CSU. So just updated perspectives on your thoughts on the commercial opportunity. And then moving on to Pella Carson, you've now guided to a 2H26 readout. Given this is an event-based study, could you just give us any thoughts on potential risks and risk mitigation for this, what appears to be significantly lower event rate? Does this run the risk of creating additional noise in the study, or is that more than offset by the powering assumptions and the design that you've built in there? Any thoughts on that would be very helpful. Thanks so much.

Yeah, thanks, Simon. So, first on the commercial opportunity, I think it's really going to be, you know, data-driven. I think our base case assumption is that an oral drug will struggle to have the same level of efficacy as monoclonal antibodies, but in hitting the B-cell pathways in MS. And because of that, you know, that still B-cell monoclonal antibodies will be the dominant class, but there will be a number of patients that would want an oral option and who don't want to go through injectable therapy. I mean, as I noted in my slide, still 25% of patients in the U.S. and 65% outside of the U.S. are on DMTs that are not, and are not on B-cell, injectable B-cell therapy. So there's a large market there on its own. And then I think it will depend if the efficacy and safety profile overall, particularly the efficacy profile in the case of Remy in our hand, is compelling enough to have a broader market. So I think we'll certainly see based on the data. But even if we take it as a given that there is a large B-cell monoclonal class out there, there is a large marketer opportunity beyond that, which we think is important. And that, of course, the question is, with the brain-penetrant properties of our molecule, does that lead to other opportunities, either in SDMS or in the control of RMS that provides another dimension? And that will all be data-driven as well. So, in this case, I'll exceptionally take the second question, but if everyone can limit themselves to one question. Pella-Carson, so we expect a mid-year readout. You know, the study is going to completion in terms of the number of events that we had originally outlined. We had powered up the study, you'll recall, during the process of the phase three. So we feel like we're adequately powered to demonstrate both at the 70 milligram per DL cutoff and the 90 milligram per DL cutoff, the CVRR that we're targeting. And so I don't think there's necessarily any risk associated with going in full. I think what it does indicate is that the event rates are lower than what we had modeled from the published literature, and I think that's just something that is just the reality now that we've found. We suspect it has to do with the fact that we've really optimally managed these patients for all other risk factors. Particularly LDL lowering. And I think that, of course, has an impact on event rates as well. So we'll see and we're excited to see this data and hopefully creating an entire new class of medicines that can help a whole group of patients that have no other option. And so I think with a positive study, we have the opportunity to give these patients a hopeful solution against sudden cardiac death and some of the other things that can happen for patients with elevated LT little a. Great.

Thank you very much.

Next question, operator.

Thank you. And the next question today is from Matthew Weston, UBS. Please go ahead.

Thank you very much. Can I also add my thanks to Harry for all his support, and best of luck for the future, Harry. Vas, Kiskali is building into a fantastic and highly profitable medicine for Novartis. And I guess the only challenge is it has an LOE just after your 2030 time window. What are the options in-house to extend the franchise further in breast cancer? And given the third data that we've seen from a competitor, what other options are there from BD that could potentially, or is oncology, I should say, a category where BD looks like somewhere you should supplement the Novartis pipeline?

Yeah, so I think there's actually two questions in there, but I'll also take both of these, Matthew, because it's you, Matthew. With respect to Kiskali, you know, I think right now we got to a mid-2031 with the pediatric exclusivity that we would expect for this brand in the U.S. I think it's longer outside of the U.S. depending on the market. Our core goal at the moment is our CDK2, CDK24, and CDK4 programs, all of which now are in the clinic, and we're advancing as fast as we can to see which of these medicines can provide either additional benefiting in the post-Ciscali setting or either in combination, and we'll see what we ultimately learn. Of course, we also are advancing our radioligand therapy portfolio. We have two HER2 RLTs now in the clinic. Those will be important to watch, as well as the Neobomacin RLT as well in breast cancer. So, a number of shots on goal, and I think those will all be very important for us to continue to lifecycle manage, as you rightfully point out, beyond the mid-2030s. I always think about it as a full-year 2032 effect for this brand. Now, I think with respect to BD and M&A, I think absolutely. I mean, we see amongst our therapeutic areas that clearly oncology is one we'll have to focus on, so we'll continue to focus there. As we have, I would say we've had just more opportunities and traction in the last years in cardiovascular, immunology, and neuroscience. You've seen us do a large number of deals in those spaces. But we'll continue to see, and of course, it's a high priority to continue to build oncology now that we have the scale we're building from Samblix, Pluvicto, Kittali. And so if we find good opportunities, good assets, we'll certainly go after them. Next question.

Thank you. Next question is from Peter Viddelt, BNP Paribas. Please go ahead.

Yeah, thanks. Peter Viddelt, BNP Paribas. Faz, just on Rapsido and Unalimab, given we're now in an MFM world, how should we be thinking about ex-US launch plans for what are clearly most significant assets? I'm basically just pushing my life to see how specific you're comfortable being about. Changing in the rest of the world launch strategies for important assets like Raphilo and Unite on the map. Thank you.

Yes, I think this is high on our minds. We're working through our strategies here on Rapsido. Given that it's already launched, of course, we would be exposed on the first pillar of the MFN approach, which is on the Medicaid rebate. It's more limited, and I think there we can manage. We think we have good options to manage the ability to launch Rapsido globally. Of course, we'll have tighter pricing corridors, but that's something we think we can manage. Unalumab is more complex as we get to launches in 2027 in the G7-plus countries. There, of course, it's on the entire market of U.S. net price, not just Medicaid. And so we're working through strategies. Absolutely, it's our aspiration to get these medicines launched in all of these markets, given to patients that need them. But we certainly can't adversely affect the U.S. market. And so we're just going to have to be thoughtful about looking at where are there opportunities to price appropriately for the value that Yonalimab brings. Given the PPP adjustments and some of the other elements of how pricing is looked at, are there things we can do to manage this? It's all in the works. I think we'll have a better sense over the course of this year on Yonalimab, but on Rapsido, we feel confident we have a way forward to get a global launch moving ahead. Thank you. Next question.

Thank you. Next question is from Steve Scala from TD Cowan. Please go ahead.

Thank you so much. I'm Pella Carson. Novartis has said previously that a delay in the Horizon trial readout would stem either from overestimating the baseline risk or underestimating the treatment effect. Do you have a sense of what is at work here? I would think the baseline risk, if it were overestimated, would question the value of lowering LPA in the first place. And I would think that Novartis should have a better handle on treatment effect based on early studies. So any color of... So Novartis' view at this point would be helpful. Thank you.

I wish we knew, Steve. Honestly, I can only give you an opinion. I can't actually give you facts because we're completely blinded and we have no data-based insights. You know, we believe that we have appropriately... We've estimated the baseline risk, and that's up to many rounds of looking at it. So, it might be that that baseline risk is more prominent at higher LP little a threshold. I think, in my mind, it really comes down to what LP little a threshold are we appropriately thinking about the baseline risk and how at. And this is, again, I think, no way to know if this is correct, but my assumption is that at lower LP little a levels, there could be more interactions with LDL and other risk factors, and that LPA becomes more dominant as you get to higher LP little a levels. And because the risk goes up almost linearly to the higher LP little a, that becomes the dominant risk factor. And so, the studies obviously have some portion of patients at the 70 to 90 to 70 to 100. We've, I think, announced in our papers that, you know, overall our median is 108. So, you know, that's kind of our best guess in terms of the risk profile and how we've estimated. Obviously, we would love for this to be that our treatment effect is larger than we expect, and that would be the reason for this, but there's just no way to know that at this time. Thank you. Next question.

Thank you. Next question comes from Richard Vosser, J.P. Morgan. Please go ahead.

Hi. Thanks for taking my question. Just a question on Itfisma. Just how should we think about the ramp of that product in the U.S. and ex-U.S.? I could imagine that there are some patients that are potentially waiting for the therapy. So, have you seen warehouse patients, and how should we think about the launch? Thanks so much.

Yeah, thanks, Richard. In general, for gene therapies, we see often a pretty fast ramp as we get through the kind of prevalent… pool of patients, and then it kind of comes down to a more steady state. And I think over the next two to three years, we would expect really at Visma to penetrate the majority of the kind of relevant patient pool that it has, and then come back down, as we saw with Zolgensma, more to a steady state because of the nature of the one-time therapy. So I think relative to other brands, the ramp will be on the faster side. It won't be in six months, but I think over the first few years, we'll get to peak relatively quickly and then come down from there. And we do have, I think, warehouse patients. We do have patients that we really understand. We also have strong access, we think, in many markets. And as we build that access forward, I think that will really allow us to maximize the medicine. Next question.

Thank you. And next question is from Graham Perry from City. Please go ahead.

Great. Thanks for taking my questions. So reiterate the best wishes for Harry, of course. And then a question on Kiskali and the outlook for the year. So how much of the gross to net impact that was impacting fourth quarter carries through into the next year because of a different channel mix versus how much is one off? And so to what extent does that give you an easy base for comparison in 2025 into 2026? And then any thoughts you have on the risk that oral serbs might pose to encroaching on CDK4-6 combinations in the adjuvant setting? Thank you.

Thanks, Graham, and great to have you back. On Qiskali, you know, I think the higher growth to NETS, we believe, is a one-time effect where we saw higher Medicare utilization than we had forecast in 2025. We do expect that the early breast cancer launch continues to accelerate and our mixed shifts to younger and younger patients that this will net out back towards where we had historically expected. And I think we should be fine from that point forward. And Harry wants to add something.

Hi, Graeme. Thank you very much. And by the way, everybody for your nice words. So, you know, one thing to note is that actually in quarter one of 25, we had a positive growth to net, as Mukul pointed out. So in quarter one, that's a higher base, you know, due to one-timers. As Vaz mentioned, the quarter four, what we have noted here, out of period adjustments. So if you take that out, it's really the true quarter four performance. And then the quarter four of 26, there should be a bit of a lower base because of this negative this year. But overall, basically, these growth to net adjustments are all out of period. So one-timers and the underlying is what you see.

And then with respect to the oral SIRS, you know, we've had a lot of discussion, and we feel confident that when we look at the profile of Castelli and what we hear from physicians, that physicians want a CDK4-6 inhibitor for patients who can benefit, and they, of course, need to look for an endocrine therapy option. Certainly, the oral SIRS now have the opportunity over time to become the standard of care endocrine therapy option. We already know that roughly half of patients in the early breast cancer setting in the U.S. are already now on a CDK4-6, and as we continue to penetrate that base of patients, we think that the opportunity will be CDK4-6 plus the choice of historical endocrine therapy or the oral SIRS, and that's how this market will play out. At the margin, could there be some physicians who choose an older endocrine therapy plus a CDK4-6 or an oral CERD and not a CDK4-6? Certainly, that dynamic will happen, but we don't expect that to be the predominant approach in the U.S. or in any of the other core markets. That's what gives us confidence in the $10 billion-plus guidance that we have and are sticking to. Next question.

Thank you. Next question today is from Seamus Fernandez at Guggenheim Securities. Please go ahead.

Oh, thanks very much, and I just would echo. Harry will miss you for sure. Vaz, hoping you could maybe give us your thoughts on the overall food allergy opportunity. You know, within your overall portfolio, obviously, Zolaire has done extraordinarily well in this space with, you know, excellent growth opportunities. Just hoping to get your perspective on that as well as the opportunity that you see potentially within your broader portfolio, not just for the BTK, but beyond. Thanks so much.

Yeah, thanks, Seamus. You know, we've had a long history looking at food allergy. It goes back to a medicine some of you will remember called QGE031, which was a high affinity IGE, F-E-I-G-E, that was supposed to be a follow-on for Zolaire. In the end, we weren't able to show a stronger effect than Zolaire has ultimately shown in food allergy. So we know the space well. You know, once we saw the Phase 2 data for remebrudinib and food allergy, I think it changed our perspective to really think now, how could we build this out to be a significant market opportunity? So we'll be sharing that data, as I mentioned, in the coming month or two. And, you know, with that data set and now the agreement with FDA on how to advance into Phase 3 studies, we see the option for a safe oral medicine to be able to hopefully be given broadly to patients. And you know that a lot of the patients that have food allergies that are most interested or at risk to be treated are children. And so versus ongoing injections, having an oral high-efficacy safe option we think would be pretty compelling. So I think overall we see food allergy as a multibillion-dollar opportunity, certainly with the potential to make something major out of this. We're going to obviously run through the Phase 3 program. We're excited to share the Phase 2 data as well. And then beyond that, now we are evaluating are there other opportunities within the pipeline earlier at Novartis and, of course, externally, as always, to see can we further bolster our food allergy portfolio. So I think it's definitely a shift, but something we're getting quite excited about. Next question.

Thank you. Next question is from James Gordon at Barclays. Please go ahead.

Hello, James Gordon from Barclays. Thanks for taking the question. The question was on Fella Carson and what a win now looks like. So you talked about a potentially lower event rate, but where is the latest magnitude of FTC bar? Because I think the original design was a 20% benefit in the broader population, a 25% benefit in a narrow population, with a longer study and maybe some other tweaks. Is that still the minimum? Is there a possibility that you could actually have a benefit for either of those groups that were statistically significant but didn't quite hit that hurdle? So would that still be a product with strong commercial prospects?

Yeah, thanks, James. So, you are correct. It is a 20% power for 20% in the 70 mg per DL group and 25% for the 90 mg per DL group. We can win on the study with a relative reduction that's lower than that, and so certainly there is the opportunity to win with CVR in the mid-teens. I think we'd have to evaluate, I think, for patients who have no other option, and if we were to win at that lower level, what would be the right approach to bring it to market? And that's something we'll have to see based on the data. But that's certainly something we'd have to look at. Of course, we hope for a much higher CVR impact, either at the lower cutoff or the higher cutoff, but we're going to ultimately have to be data-driven. There were no other changes, though, from a protocol standpoint, from a study design standpoint. Everything is as it was when we originally started the study with respect to powering, etc. Thank you. Next question.

Thank you. Next question is from Michael Doughton from Jefferies. Please go ahead.

Thank you. Question for Harry, please, given it's your last time with us, and thank you. Harry, the SG&A expenses for fourth quarter were extremely tight, very good performance there, helped you to gear the margin underlying terms. As I think about the margin for 2026, obviously you do have the avidity dilution, but if that SG&A control continues, I struggle to see how you're going to get as much dilution, especially if avidity doesn't quite close as quickly as maybe it could. So can you just talk about the repeatability of that SG&A performance in the fourth quarter into 2026?

Yeah, thank you, Michael. Actually, any 2026 question is kind of from Mukul, so I will hand over in a second. But, you know, historically, we always had quite an increase in quarter four. So we took this year to say, look, this is inefficient, you know, to have such a peak in a quarter where you have, you know, one to two weeks of Christmas and you have also the U.S. Thanksgiving and so on. It shouldn't be actually a big peak here. So we took that in order to even a bit out. And overall, we will continue, and Mukul, of course, will drive productivity programs. But avidity, just one thing. I mean, the day before quarter three earnings, when we took you all through the avidity deal, we said it would be a 1% to 2% margin point dilution effect, given the unusual high development cost per the next two to three years of a late-stage development product with a very Expensive medicine from a COX, especially when it is under contract manufacturing. So not everybody has figured this into the consensus. It's okay when people don't follow everything we say, but we have mentioned it to you. And one to two points, if you say one and a half, it's pretty much what you get when you have a low single-digit increase on sales and a low single-digit decrease in cooperating income. So we feel we have implemented exactly that. Without Avidity, it would have been unchanged margin, basically. But Mukul, what do you think?

Yeah, no, Harry said it all. I think it's a short answer, a short add-on to the answer that Harry gave was the SG&A cost control productivity plans within the organization. It's something that we as a company feel very proud of and what has been achieved in the last four or five years. And as we go into our next five-year journey, this will absolutely continue going forward. There is a certain bit of margin dilution that we had predicted, and that's the reason that we gave clarity on H1, H2, because if you look at how once the GX for this year are going to come off the base, we actually see co-operating income starting to grow, and that kind of sets the base or sets the expectations for what to expect of our P&L in the next four years to come.

Thank you both. Next question?

Thank you. We'll take the next question, and this is from Thibault Bousserin from Morgan Stanley. Please go ahead.

Yes, thank you. Just a question on Cosantics and the dynamic in the HS market. It looks like the shares have been stabilizing for some time between Cosantics and the main competitor in terms of NDRX and Total Script. So, from here, is it fair to assume that both drugs should grow in line with the market? And I think the last issue is to say the HS market should expect a growth around 15%. So, just want to know if it's the type of growth that you're still seeing today.

Yeah, thanks for the question, Thibault. So, you rightfully point out we've seen stabilization in the overall NBRX share in the market. As I noted, we're kind of in this 48% to 50% range, and then we see the two other medicines splitting the remainder. We're doing very well in the naive population, and then in the switched segment, we see our competitor performing very well. So I think that's kind of the dynamic. We've seen that dynamic kind of stabilize now. So we would expect that dynamic to continue going forward. So I think both all brands will grow based on the market. Now, clearly, the market potential here is quite large. It's just a matter of how effective we are at getting patients to come in to get treatment. So we continue to see this kind of $3 to $5 billion market opportunity, but could it be larger if we were able to mobilize with two competitors and potentially more future competitors coming in, the market growing faster, certainly? And we, of course, want to capitalize on that. And that's part of the reason why we, you know, study Rapsido in HS, because we see the opportunity here to build this market, hopefully with a high efficacy safe oral to then go make the market even larger. So something we'll continue to work to build and hopefully get more of these patients who are kind of lost to treatment, probably were on a TNF, ultimately not successful, get those patients back into the medical home and back on therapy. Next question.

Thank you. Just a reminder, if you would like to ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. We will now take the next question. This is from James Quigley from Goldman Sachs. Please go ahead.

Great. Thank you for taking my questions. And my thanks and congrats to Harry as well for the next chapters. My question is on the LP-A portfolio. So as you showed in the slide, you started a new trial, a phase two trial for DII-235. Firstly, what are the dosing intervals? Are you going to be testing for that drug? And secondly, at the meet-the-management event, as you were saying, if Horizon were positive, that could then lead a decision to move some of the longer-acting LP little-A straight into Phase 3. So are there other assets in the portfolio that you're holding back, waiting for Horizon to move into Phase 3? Is this phase to a function of a push-out in Horizon, or is it just you want to see more data beforehand before making a final decision here on which assets to take forward? Thank you.

Yeah, thanks, James. So, for DIA-235, our partner, Argo Biosciences, I think publicly released that this is – has had, you know, already strong data in the early Phase 2 study and has a potential for an annual dosing interval. And we are prepared to move that study – that program directly into Phase 3 based on the Horizon data set. So, there's no change in our plan. I don't – there might be different things happening between our studies and their studies, et cetera. Our strategy very much is based on the Horizon readout to then, based on the data we've seen with DIA-235 on an annual dosing interval, to move that forward then into late-stage studies. We do have, of course, a range of other programs, earlier stage as well, on a range of cardiovascular assets. We've talked about that in the past, HMG-CoA reductase, annual PCSK9, of course, the angiocensin-2-sirRNA, and then combination programs as well that we're working on, both at the six-month interval and at the one-year interval. And so, both because we need the lifecycle to manage Lectio, but also be prepared that the horizon is positive to be ready to come with what we think will be the preferred market option. We want to be ready for all these eventualities.

Great, thank you.

Thank you. And the next question is from Peter Verdelt, BNP Paribas. Please go ahead.

Thanks, people at BMP. Just a follow-up for you, Val, on the pipeline. Just on this basket of cell therapy programs in autoimmune, I think some of them do read out next year. Just wondering if you've got it in the top of your head in terms of which ones, which indications, and perhaps a general temperature check on your behalf in terms of your level of enthusiasm for these programs. Thank you.

Yeah, thanks, Peter. We remain, you know, enthusiastic. We have a huge effort internally on YTB as a first instance, currently in pivotal studies, aligned with FDA over four indications. And then with follow-on programs that are now in proof-of-concept studies in three, four additional indications as well, and then additional exploratory work that's ongoing. And then behind that, tri-specific and bi-specific monoclonals also to explore, can there be alternative options for certain patient groups in the immune reset? I think the first readouts we'll have will be in SLE lupus nephritis. That's building off of the data we presented last year on 2023 or 2024 patients where we showed, I think, pretty spectacular results for those patients in terms of rewinding the progress of their disease other than the permanent damage that had happened to the kidneys. And so, quite exciting data. That's allowed us, I think, to move forward on that study quite quickly, but we also are advancing all the other programs. And some of them, if we're fortunate, might even be able also to read out next year, depending on enrollment patterns and enrollment timelines. So, we're advancing these as fast as possible. Depending on the program, many of them have alignment with FDA that we can file off of a single arm and then continue on to provide data on randomized data sets. Others need the randomized upfront, so that all varies based on indication. But I think a lot of the enthusiasm and focus inside the company.

Thank you. Thank you. We'll now take the next question, and this is from Michael Luchten from Jefferies. Please go ahead.

Thank you for the follow-up. Vas, just on Semblix, you helpfully provide the shared data across lines of therapy for the product. It looks like it's plateauing in first line in the U.S. a little bit over the last few quarters. What's stopping the momentum to continue?

Yeah, thanks, Michael. So we have looked into that. One thing to note is the data is very noisy because with CML, it's a rare disease. Most physicians only see one or two patients, and so the data here always is getting restated. Overall, our view based on our internal assessments is we continue to see steady share growth on the frontline setting. Actually, I would say our frontline share growth is ahead of our plan and our original planning assumptions. And so we see the opportunity here to really continue to grow. We have really strong broad access. One of the biggest things we're trying to overcome is perception that we don't have strong access to get that access perception to where we want it to be. And then, of course, as we've outlined in the past, you do have Levek loyalists out there who want to stay with a product that they've used for a long period of time. That will be more of a refractory group. But to get from the mid-20s up to the 40% to 50% share range is absolutely what our ambition is, and we see a path to get there. Thank you. Next question, or I think this might be the last question, Operator.

Thank you. So the last question today is from James Quigley from Goldman Sachs. Please go ahead.

Hello, thank you for taking a follow-up. I've got one quick one on Zyger-Kaibart. The data has been pushed out a little bit in order to have the EGFR data on the label at launch, but as you think about the strategy here with your other assets, whether you had the UPCR data first and then adding the EGFR data, is this a case that the data were quite close together so it was worth having a delay, just trying to understand the rationale here versus the other mechanism, Or is there something around the Ziger-Kaibart mechanism that could lead to stronger benefit on EGFR relative to UPCR? Thank you.

It's a great question, James. I think when we looked at the number of competitors entering in the anti-April space, we asked ourselves, given we already have a strong portfolio in the nephrologist's office, what would give us the most compelling data package to kind of cut through all of the various launches that are ongoing? And we felt coming right away with hopefully the second medicine with a full approval, clear proteinuria reduction, and EGFR benefit would give us, you know, a very compelling proposition. We theoretically, assuming everything goes as we hope, we would have three medicines in IGAN with EGFR outcomes benefit across Subhalta, Van Raffia, and Zygachibar, and that would give us a very compelling proposition. So we thought that was prudent, given that the time that passes here is three quarters, it's not the end of the world, and then we would have a much more compelling data set to provide to FDA.

Got it. Thank you.

All right. Well, thank you all very much for joining the conference call. We'll look forward to keeping you up to speed, and we wish you all a great, great 2026. Thank you.

Thank you. This concludes today's conference call. Thank you for participating, and you may know.