Sandoz Group Ag S/Adr

Good morning, ladies and gentlemen, and welcome to the Sandoz call today. I will now hand over to Craig Marks, head of investor relations, for his opening remarks.

Thank you and welcome to the Sandoz full year results call for 2025. Earlier today, we published a press release and an accompanying presentation on our website, which will follow on today's call. You can find these documents at Sandoz.com stroke investors. Joining me on today's call are Richard Seynod, Chief Executive Officer, and Remco Steenbergen, Chief Financial Officer. Please turn to slide two. Our results announcement, presentation, and discussion include forward-looking statements. Please see our disclaimer here. Please turn to slide three. Richard will begin today's presentation with the highlights of 2025, followed by an update on the business. Remco will cover the financial performance, as well as the guidance for 2026. Following the wrap-up of the presentation, we'll be happy to take your questions. And with that, I will now hand over to Richard. Please turn to slide four. Thank you, Craig.

And hello, everyone. It is a pleasure to welcome you all on the call today. Our second full year as an independent company was a very successful one, and I'm proud to share our achievements. 2026 is a significant year for us as we celebrate some very special anniversaries that reflect our legacy and our future. 20 years ago, Sandoz pioneered the world's first biosimilar, opening the door to advanced treatments for more patients and setting new standards for access and affordability. 80 years ago, we transformed a brewery into a penicillin factory, making antibiotics more accessible and saving millions of lives. Kundal remains Europe's last major end-to-end producer of penicillins, a legacy of reliability and innovation. And I'm delighted that we're also celebrating 140 years of Sandoz. These milestones are more than history. They are a source of pride and inspiration as we build our future. The reminders of the impact that we have made and the responsibility we carry to continue expanding access for patients everywhere. Please turn to slide five. I am proud of the progress that we made last year when we cemented the fundamentals of our long-term growth potential. Let me take you through the four key areas where we made meaningful steps forward. We advanced our deep, diversified, and industry-leading pipeline last year. Crucially, this pipeline already includes 27 biosimilars, 2025 was also a year of successful launches. We rolled out a number of important medicines like Pistiva in the US, Afclir in Europe and Australia, and Wyest and Gibonte in the US, Europe, Brazil, and Australia. And as the last of our Capital Market Day commitments, I was delighted that we launched Tyruco in the US. On the development and supply side, we completed the acquisition of Just Evotech Biologics Europe at the end of the year. which strengthens our technology base and accelerates our ability to scale next generation biosimilar development and manufacturing. The construction of our biosimilar hub in Slovenia is also progressing very well. And finally, it was a year of strong results across the P&L, cash flow and balance sheet. Net sales grew by 5% to constant currencies to $11.1 billion. Our core EBITDA margin expanded by 160 basis points to 21.7, driven by improving mix of sales, cost control and operating leverage. The return on our invested capital increased to 14.5%, reflecting growth of two percentage points. And finally, we're proposing to increase the dividend per share by one third to 80 cents a share in Swiss francs. Now, let's move to more details of the growth in net sales, starting with slide six. Looking firstly at the full year, net sales surpassed $11 billion for the first time, supported by biosimilar growth of 13% at constant exchange rates. Whilst generics provided a strong foundation for our business, the overall performance reflected the increasing contribution from biosimilars and strong execution across our organizations. Biosimilars now represent 30% of total net sales, marking a significant milestone for our business and one we are proudly achieved earlier than expected. I am proud to say that quarter four represented our 17th quarter of consecutive growth, underlying sales up by 7% and biosimilars representing 31% of the total. Please turn to slide seven. Generics remain a core growth engine for Sandos. Here you can see some examples of the many launches last year, such as iron sucrose, river oxyban and an exoparin sodium. We have more than 400 generic assets in development, targeting an originator market worth around $220 billion. Moreover, we're focused on a significant number of LOE opportunities, particularly in oral solids and injectables. Lastly, our global generic footprint includes four development centers and 15 in-house manufacturing sites, ensuring agility and reliability in supply. It is worth noting that the adverse impact last year on penicillin B2B business, Asian suppliers engaged in significant price dumping for key penicillin APIs, including some that we sell to other businesses. This impacted the sales value of this part of our business in the second half and We expect it to continue impacting our generic performance in the first half of 2026. Furthermore, the recently announced introduction of minimum import prices in India for some penicillin APIs may well divert low-priced supply towards Europe, which continues to depend on Asia for key intermediates. Europe's growing dependency on a handful of global suppliers underpins our call for a fundamental shift in how Europe thinks about antibiotics, the backbone of modern medicine, especially given that they're a key part of the continent's security infrastructure. Please turn to slide eight. Now turning to biosimilars. 2025 was a great year for this key part of our future. We delivered multiple successful launches that reinforced our leadership and execution capabilities. There were two major launches for Peacechiva. Firstly, we launched in the U.S. earlier in the year, which included private label options. Secondly, we introduced the first commercially available auto-injector for ustekinumab in Europe, a major step forward in patient convenience. Next, Tyruco saw strong uptake in Europe and was rolled out across the U.S. in November. We also achieved a significant milestone with Weiss & Giovanti, the first denosumab biosimilars in the U.S., followed by the launch in Europe in quarter four. And finally, AFCLIR entered the European market at the end of 2025 with the U.S. launch anticipated by quarter four this year. And you probably saw the great news last week that the FDA has approved an expanded label for Envisu to include multiple retinal indications. I fully expect these launches to perform strongly and contribute meaningful growth for Sandoz. Please turn to slide nine. Let me now walk you through the continued performance of Peacejiva and Hyramoz across our key markets. Starting on the left, Peacejiva in Europe, we see very solid trajectory. What's particularly encouraging is the sustained increase in biosimilar participation, which continues to expand quarter after quarter. This reflects not only strong underlying market growth, but also the faster uptake of ustekinumab biosimilars compared to what we saw with adalunumab. Alongside the autoinjector rollout last year, we're getting ready for more Beesgiva launches in Europe and international in 2026. Hyramaz continues to demonstrate strong global growth. Our market share remains stable, and we continue to see strong increases in biosimilar participations. we're very well positioned to benefit from this trend. Please turn to slide 10. Now, let me turn to Tyruco and Omnitrope. Starting with Tyruco, we're very pleased with the continued rates of adoption in Europe. Since launch, our market share has grown steadily, reflecting the strong clinical and economic value proposition of Tyruco as the only biosimilar approved in Europe for relapsing remitting multiple sclerosis. Alongside the recent launch in the US in quarter four and additional launches planned across other markets, we expect uptake to further expand as awareness and familiarity grow. Omnitrope continues to demonstrate exceptional stability and resilience in a highly competitive category. We've maintained the leading global market share and we're delighted with the performance, especially in the international region. Overall, Both medicines showcase the strength and diversity of our portfolio. Tyruco as a high-potential launch with accelerating adoption, and Omnitrope as a reliable, long-standing leader in the class. Please turn to slide 11. Let me now highlight the strong progress that we're making with Weist and Javonte. Firstly, in the U.S., our launch execution has been highly effective. we were able to rapidly leverage our commercial footprint that covers more than 80% of the Denosumab market volume to ensure broad visibility and accessibility from day one. We also successfully established average selling pricing, a critical milestone for provider confidence and reimbursement stability. And I want to call out the performance of Wyest and Gibonte in Canada, where we've taken extremely high levels of share across the Denosumab biosimilars. Turning to Europe, the launch of Quarter 4 has been progressing well. Our leadership across both hospital and retail channels has helped us execute with speed and precision. This strong, on-the-ground presence is enabling us to secure access, build awareness, and support physicians as they integrate Weiss and Gibonte into clinical practice. Overall, being first to market with these medicines has given us a powerful head start, and the early update confirms that our strategy is working. We're well positioned to continue building momentum as access, adoption and payer coverage expand across the regions. Please turn to slide 12. Our pipeline is where the next wave of growth begins and is designed for high impact. We're advancing targeted development in key biologics and therapies with a clear focus on areas that matter most to patients and healthcare systems. In the nearer term, we have several assets already in regulatory review. Looking further ahead, our clinical development portfolio includes major immunology and oncology assets, such as Opidivo, Keytruda, Akrivas, and T-Centric, biosimilars to some of the most widely used biologics today. Finally, we have a significant number of assets in early development. This pipeline positions Sandoz to lead in biosimilars for years to come, delivering scale, innovation, and access to patients. Please turn to slide 13. I am delighted by our sustainability progress in the year. In 2025, we serve over 1 billion patients across more than 100 countries, a scale that underscores our global responsibility. Through our portfolio and partnerships, we've delivered $26 billion in savings to healthcare systems. This is a meaningful relief at a time when affordability pressures continue to rise. We've delivered measurable reductions across our emissions footprint, down 18% in Scope 1, 15% in Scope 2, and 1% in Scope 3. We've also submitted our SBTI targets for validation, covering all emissions scopes, reinforcing our commitment to transparent climate action. Finally, on governance and integrity, we strengthened oversight and risk-based controls to ensure swift information decision-making without compromising compliance. And we continue to lead in transparency with open, compliant transfer of value disclosures across more than 36 markets, aligned with global codes and standards. Altogether, these achievements reflect who we are as a company driven by purpose, committed to access, anchored in strong values, and focused on delivering long-term impact for patients, partners, and our people, as well as society. Please turn to slide 14. To secure long-term leadership in biosimilars, we're expanding our pipeline and commercial presence has been accompanied by a significant investment in strategic integration and the expansion of in-house capabilities. I'm excited to say that this year we'll begin to complete the building of our end-to-end European Biosimilars Hub in Slovenia that includes a state-of-the-art technical development centre in Ljubljana, a high-tech drug substance production site in Lendeva and an aseptic production centre in Brinik. These facilities will give us full control over development and manufacturing, ensuring quality and scalability. Secondly, our acquisition of Just Evotech Biologics in Europe at the end of 2025 marked a major step forward. This brought us more capacity for growth, as well as proprietary platforms for integrated development and indefinite license to use Just Evotech's continuous manufacturing technology. Finally, Our overall European buy similar manufacturing network will position us as a unique leader in in-house development and production, strengthening supply security, enabling us to respond quickly to market needs. Together, these investments will allow us to capitalize on the overwhelming buy similar market opportunities that lie ahead. And with that, I hand over to Remco on slide 15.

Thank you, Richard. And hello to everyone. Please turn to slide 16. We delivered strong underlying net sales growth of 6% in 2025, driven by another year of double-digit expansions in biosimilars. Importantly, this momentum was broad-based, with all regions contributing, underscoring the resilience and diversification of our business. Core EBITDA increased by 14%, with the margin expanding by 160 basis points to 21.7%. driven by a favorable mix shift, disciplined cost management, and continued operating leverage. On cash generation, we increased management-free cash flow by $435 million to $1.5 billion, reflecting a strong underlying EBITDA performance. We improved core ROIC by 220 basis points, reaching 14.5%. This uplift reflected an improved operating performance and disciplined capital deployment. It's an important indicator that our strategy is delivering not only earnings growth, but equally also high quality returns. Finally, core diluted EPS grew by 33%, benefiting from the increase in operating profit, reduced financial expenses, and a lower effective tax rate. Please turn to slide 17. Turning to our top-line performance in more detail, our generics business accounted for 70% of the total. The main growth engine, however, continues to be biosimilar, with the results reflecting successful launches and sustained adoption. Regionally, the performance last year was well balanced. Europe remains our largest market, representing 54% of total net sales, and delivering on strong underlying demand across both generics and biosimilars. International markets net sales were 2.7 billion US dollars or 24% of sales, supported by a robust performance in emerging markets and continued expansion of access-driven programs. North America contributed 22% of total net sales. Please turn to slide 18. Over the full year, The 18% underlying biosimilars growth included encouraging contributions from Pischiva and Hyramos in Europe and Omnitrope and Hyramos in international. In North America, Weierstein-Giobonti got off to a flying start. Generics growth of 2% for the full year reflected many successful recent launches, including Paclitaxel in North America, with international performance benefiting from price accretion. In Q4, Biosimilars delivered an even stronger underlying growth of 20% with generic sales up by 2%. Now let's have a look at the performance of our three regions on slide 19. Europe's sales grew by 6% in the year and in the quarter. Strong growth in Biosimilars continued, partly reflecting successful launches over the past two years, including Hyrumos, Pischiva and Tyruco. International sales were up by an underlying 9% in the year and even by 14% in the quarter, with strong contributions from IROMAS and Omnitrope. North American sales grew by 5% in the year on an underlying basis and 2% in the quarter, with the latter period adversely affected by the impact of a one-time gross-to-net generic adjustment in Q4 2024. Please turn to slide 20. In breaking down the sales performance for 2025, you can see that volumes contributed 8%, while price erosion remained at a moderate 3%. Foreign exchange had a positive impact of 2%. Let's now move to the P&L overview on slide 21. Core gross profit increased by 5%, reaching 5.6 billion US dollars. A broadly stable gross profit margin of 50.6%, mainly reflected the favorable movement in the mix of sales offset by price erosion. Core EBITDA growth of 14% at constant currencies was primarily driven by our growth while keeping our SG&A cost in US dollars stable. Going forward, our ambition remains to limit SG&A cost increases to the absolute minimum, while we will support our pipeline through focused and increased DNR investment. Finally, core EPS grew by one-third. Overall, 2025 was a year of strong profitability, underpinned by biosimilar growth and disciplined execution across the business. This positions us well for continued margin expansion and long-term value creation. Please turn to slide 22. Moving to the core EBITDA margin performance, this increased by 1.6 percentage points from 20.1% to 21.7%. The favorable mix of sales benefited the margin by 1.3 percentage points, while price erosion at a 1.1 percentage points adverse impact. We reduced the ratio of OPEX to net sales led by SG&A, reflecting disciplined cost management, and the success of our transformation program. This illustrates the progress we are making in leveraging our cost base. From the P&L, now let's move to cash on slide 23. I was really delighted with the 1.5 billion US dollars of cash we generated last year, which represented a $435 million increase over the previous year. While we exclude one of items when focusing on management-free cash flow, the performance reflected both the strong uplift in core EBITDA and continued discipline in how we manage working capital, particularly inventory. As Richard mentioned, we have continued to invest in our future, with CAPEX in 2025 focused on the Biosimilar Hub in Slovenia. Please turn to slide 24. Last year, we successfully further strengthened our balance sheet and improved our maturity profile. A substantially stronger euro and Swiss franc against the US dollar had an adverse impact on net debt, which ended the period at 3.6 billion US dollars. When excluding the impact of foreign exchange, however, underlying net debt decreased by 200 million US dollars to 3.1 billion US dollars. Our strong balance sheet, improved liquidity, and investment grade ratings placed Sondos in a unique and excellent financial position to support our ambitions. Our net debt to core EBITDA ratio improved to 1.5 times, reflecting continued balance sheet strengthening. Please turn to slide 25. Turning to CAPEX, we invested around 700 million US dollars in 2025. with a majority directed towards manufacturing. This reflects our continued build-out of our development and manufacturing vertically integrated biosimilar capabilities. Looking ahead to 2026, our peak year for CAPEX investments, we expect an outlay of around 1.1 billion US dollars. The largest allocation will again be for strengthening our biosimilar capabilities. As Richard stated before, we expect our development and API biosimilar sites to be completed at the end of 2026, before we move to the tech transfer process. We anticipate completing the construction of our biosimilar full-finish site next year, i.e. 2027. We expect to enhance our biosimilar pipeline through BD&L investments, and we will continue our path to bring our IT infrastructure at required levels. The uplift in IT will enable system upgrades that are designed to drive efficiency, streamline our operations globally, and create a more scalable digital backbone. Please turn to slide 26. One-off costs continue to decline. In 2024, these costs peaked as we completed the bulk of the work related to separation, transformation, and the manufacturing footprint. In 2025, one-off costs declined to around $0.4 billion, reflecting a lower level of separation-related spending and reduced transformation activities. For 2026, we currently estimate the one-off costs to further decline to around $0.3 billion. This means that the one-off costs of $0.7 billion for 2025 and 2026 combined are fully in line with our prior expectations. Please be aware that one-off costs exclude software implementation cost accounting impacts. We're in the process of implementing new future-ready IT systems for Sandoz. Due to the nature of software licenses meeting the accounting definition of software as a service, the related implementation costs do not meet the criteria for capitalization as intangible assets under IFRS. We have not guided for these costs historically, as the assumption has been that such costs can normally be capitalized. These costs were around $50 million in 2025 and are likely to be similar this year. Please turn to slide 27. This year, we expect next sales to grow by a mid to high single-digit percentage in constant currencies, supported by the impact of our recent launches. The EBITDA margin is targeted to increase by around 100 basis points. We expect price erosion of a low to mid single digit percentage. We also anticipate that the adverse dynamics of our penicillin B2B business will unfortunately persist in the first half of 2026. And as a one-off, we incur some costs related to the integration of the JustEvoTech business in France. Outside of guidance, we expect two percentage points tailwind to net sales from currency movements. based on recent spot rates and average rates in January, 2026. We do not expect a material impact from currency movements on the core EBITDA margin. Please turn to slide 28. Our hard work since the spin has led to strong results to date, which position is really well to reach our midterm outlook for 2028, which is unchanged. We have strong momentum, supported by numerous launches across key markets, and there is a clear visibility on the drivers of our margin expansion. And on that happy note, I will hand back to Richard. Please turn to slide 29.

Thank you so much, Remco. I'd now like to wrap up the presentation on slide 30 before we go to questions. I'd like to remind everyone of the huge number of opportunities that lie ahead. The next golden decade presents a tremendous opportunity for Sandoz in both biosimilars and generics. On the biosimilar side, we're targeting more than $320 billion in LOE opportunities, with 27 assets currently in development. These represent approximately $200 billion of originator sales, covering nearly 60% of upcoming LOEs. Combined with the game-changing impact of recent regulatory streamlining, This positions us extremely well to accelerate access and capture more market share. On the generic side, the potential is equally compelling, around $340 billion in LOE opportunities supported by a pipeline of more than 400 assets. These represent another $220 billion of originator sales, or approximately 65% of LOEs over the next decade. And beyond that, we see GLP-1s as a long-term growth driver. Together, these pipelines create a powerful foundation for sustainable growth. Please turn to slide 31. In 2026, we'll continue to strengthen our leadership in affordable medicines by advancing our network, our portfolio and our pipeline. We'll complete the construction of key new biosimilar facilities in Slovenia. And with the strategic acquisition of Just Evotech Biologics, I am confident that we will consolidate our position as the undisputed leader in biosimilars. Vertical integration will give us clearer control over our pipeline development and underscore our unwavering commitment to expanding access to high-quality, affordable biologics for millions of patients worldwide. At the same time, we will continue to focus on accelerating access for patients. One example will be the launch of Envisu in the US by Q4, which represents another key addition to our ophthalmology portfolio. And finally, Flawless execution remains central to how we operate. Across the organization, we're reinforcing capabilities, executing consistently against our strategic priorities, and continue to embed our pioneering culture in everything we do. I am delighted by our progress and by the strong momentum in the business as we move into 2026. I want to express my heartfelt thanks to our colleagues for their dedication and passion which makes such a difference for patients around the world. Thank you so much for listening. Please turn to slide 32 and I'll ask the operator to open the lines for Q&A. Thank you.

Ladies and gentlemen, we will now begin our Q&A session. If you have a question, we ask that you please use the raise hand function at the bottom of your Zoom screen. Or if you have dialed in, please press star nine to enter the queue. Once your name has been announced, you can ask your question. If you want to withdraw your question, please lower your hand using the raise hand function in the Zoom app or via telephone, press star nine. Thank you, and a moment for the first question, please. Our first question is from Charlie Hayward from Bank of America. Please unmute your line and ask your question.

Hi, Charlie Hayward, Bank of America. Thank you for taking the question. It's on the Denosumab Flying Start that you call out. I think data suggests fourth quarter US DenosMap sales trending to around the mid-double digit million dollars per month level. So is that ballpark sensible? And then does your guide reflect an annualization of those fourth quarter levels into 26? Or is there anything we should consider on competition or pricing dynamics that might change that? Thank you.

Good morning, Charlie. Thank you for your question. Yeah, we were delighted with the launch. Obviously, we launched alone in a market. We set our ASP and executed well. I think, look, clearly, we expect volume gains to continue pretty much to that level, if not a little bit higher. But clearly, you've got a significant number of competitors coming in, which will naturally push down the pricing. So, I think the net will probably balance out, but clearly we're delighted with where we've started. We're still seeing strong growth and expect a good performance during 2026.

Thank you. Our next question is from James Gordon from Barclays. Please unmute your line and ask your question.

Hello, James Gordon from Barclays. Thanks for taking the question. First of all, just with GLP-1s, I heard you talk about it being a longer-term growth driver, but no material contribution in 26. So where do you think you now could resolve a launch in Canada? And what's the plan in Brazil? Is the plan still that you could launch with a vial? And longer term, so Novo's oral Regovilog is going well, which is also semaglutide. But will you do oral Sema? So it's got the snack technology and it needs more API. Is that also something that's in your plans or is a product like that not really attractive for a generic company? And the GLP-1 plans you have are just to do injectable. And then the second question was just, well, the quick one, which was just, so you have got one at ADC, you've got in HER2 in development. and you cost to develop ADCs and bispecific bisimilars. Should we think that that's just a start and you're going to do quite a lot of ADCs and bispecifics, or are they still significantly more complicated to develop and more expensive? So in her two is a bit of a one-off.

Great. Good morning, James. Thank you so much. And thank you for getting the GLP in question in early. So, Look, we've not guided because I guess there's so many variables at the moment. We've filed in Canada, Brazil, a number of other markets with one or more partners. Because when we get an approval and we launch a product, we will launch it. I've still said, look, we would look to anticipate to launch it probably in the latter half of this year in Canada. But we're very much dependent on the regulators. And at this point, nobody's got an approved file. Similarly with Brazil. I think in the medium term, yes, it's a very attractive market. But I think I commented before, I've never known a product where I don't really understand how the volume dynamics are really going to play out, given that demand is far greater than the market can supply. So I think it's just prudent that we sort of learn as we go a little bit. And I always said I see Canada and Brazil to a lesser or greater extent as sort of a bit of an experiment in terms of how markets dynamics will grow. As a generic company, yes, we will focus on bringing any product that we think is an attractive market opportunity, whether it's an injectable asset or in the medium term, an oral presentation of semaglutide. We've not disclosed our pipeline in small molecules, but naturally we want to cover ideally about 80% of LOE of any product, certainly in Europe. And that logic, I can't see, or that logic should also apply to GLPs. But I think we're quite a some way from the patent expiring from an oral GLP, and then there's still the dynamic of what that's going to play with the Lilly asset over the next couple of years. So this is really a long journey. We're going to be in it, and we'll share our journey with you as we do it. In terms of ADCs, I think it's less the cost of the development, to be brutally honest. Surprisingly, it's not that technically difficult. You've got to remember, we are a small molecule company and a large molecule company. So our technical ability to link those two things is already embedded, whether it's ADCs, bispecifics or even trispecifics. I think the question is more about the regulatory framework. You've got to remember 20 years ago when we launched the first biosimilar, there wasn't really a regulatory framework about filing and launching your biosimilars. That now has radically changed for monoclonals, and you're seeing that progressing quite quickly. We're working closely with the regulators to find the right path, so we do a reasonable amount of study work. but not an excessive amount of study work. And I think at the moment, that's where the cost is. It's not really the technical development. It's more the studies to satisfy the requirements of the regulators. We've not disclosed the quantum, but certainly, look, it's going to be more expensive than a classic monoclonal. But yes, we would expect to expand to that pipeline over the coming years.

Thank you. Our next question is from Harry Sefton from UBS. Please unmute your line and ask your question.

Brilliant. Thank you very much to take my question. So I just want to touch on slides nine and 10 of the presentation. So given the progress on some of those biosimilars, it looks like that you're hitting more peak market share for those. So I would have implied that the strong guidance for the year is more for the more recent launches of Denosumab, Tyruco and Aflibicept. So would love for you to touch on the progress for Denosumab and Aflibicept in Europe specifically. And then also for Tyruco in the US, given the REMS program that you set up there, what do you expect in terms of the progress or the trajectory of the launch in the US? Thank you.

Good morning. Thank you, Harry. Perhaps I'll start with Taruko first. Look, we're delighted to have brought that product to the market. It was the last piece of the CMD commitment, so very pleased that we delivered that. Our strategy is to, at this phase, to acquire new patients rather than go for converted patients. I think that way... Physicians, clinics really get to work with us and the product. And so that means really the pickup will be incremental rather than switching. So that's very much what we're seeing in the market, that we're adopting new patients as they come on board. Gaining the confidence is well accepted by the clinicians that we're working with. And so we look forward to sort of a stepped growth over the next few years rather than sort of a rapid conversion of the market, which I think this way will be much more sustainable. Deno in Europe performing extremely well. Again, I think the data we take in the leadership position, a strong response from payers and great acceptance of the product. Obviously, I think in the medium term, how we expand that market, not just in the oncology indication, but also for the osteoporosis indication where I think in Europe, because the price differentials are so great, is still an underserved population. So I think there's really nice opportunity to expand and grow that. And then Aflibicept has been a very entertaining journey over the last few months, also with German Court, etc. But really delighted with the launch, probably running a little ahead of where we expected in terms of volumes. And then clearly pleased with the recent IP or PI development. in junctionary reversal in Germany, which again means that we're now back on the market and a number of our competitors are still blocked. So I think we set up extremely well. I'm very pleased with the early positioning of those products. And then your broader shape, I think is directionally right. I mean, look, Oosterkinimab, we're still seeing strong market gains in terms of penetration of the market. Adalunumab is still growing years after LOE. But clearly, the bulk of the growth, you rightly point out, is going to come from our new launches. And I think, you know, we almost get a bit complacent, but we've had a record number of launches into Europe last year with Athli, with Dano, with Ooster, again, with the only one with the auto injector. Obviously, we're just bringing now a Lucentis biosimilar later into this year. So a great set of positioning to set us up well for growth 26 and into 27. So we're built on a solid foundation of the rest of our assets.

Thank you. Our next question is from Victor Flock from BNP Paribas. Please unmute your line and ask your question.

Oh, thanks a lot for taking my question, Victor. So my first question relates to the recent FTC settlements with Express Scripts, which seems to have weakened rebate-driven preferences for highly-priced brands and to some extent favor lower net cost products. So I was wondering whether you see this as a... structurally affecting the biosimilar market in the U.S., and is this directionally aligned with the PBM reforms you've been advocating for over the last few years? And my second question relates to your long-term pipeline with some recent analysis suggesting that some certain originator might be able to delay biosimilar entry longer than expected. leveraging their complex IP situation. And I'm thinking about Keytruda and Semaglutide. So you've been quite vocal in the past regarding the unpredictability of the U.S. market on that front. So I was wondering whether you can discuss whether this impacts your long-term biosimilar plans in the U.S. and whether you continue to call for some reform on this front. Thanks so much.

Okay, thank you so much, Victor. The technical question you brought up, I'm going to have to come back to you, I think, in terms of the rebates and what that impact is. So rather than try and answer that now and take time, we'll come back separately through Craig. I think the broader question, I mean, it's an environmentally, I think we're moving in the positive direction in the US. I mean, clearly, having conversations around PBM reform, patent reform, clear the right moves with the FDA. So I think there is never one solution here, but I think certainly I'm much more optimistic about the direction of travel in the U.S. And again, as I said before, our access to the administration in terms of having a sensible dialogue about delivering sustainable, affordable medicines in the U.S. continues. So I think that's clear. In terms of the long term pipeline, I think it's a fair question. As I've always said, in a sense, we define our biologics pipeline with a European lens to the very point that you make, because there's so much uncertainty. Obviously, we filed against Amgen on Ambro because they've managed to create a 31 year patent life. That case got overturned last week. We're still judging whether we would appeal. And we're all interested now that actually a number of payers are now suing Amgen for abuse of their position as well. So I think there's an environmental shift in the U.S. that this lazy innovation from iterators, particularly in the U.S. market, to prolong and abuse patents is being challenged both at a Congress and a Senate level, but also from the industry and the payer level. So I'm encouraged But certainly it's a challenge. But it doesn't change our strategy because really we define our pipeline from a European point of view where we generally have a fairly clear sense of when we would bring a product to the market. And then the U.S. becomes a fantastic opportunity rather than the other way around. Because if we balance everything on the U.S., you've always going to end up in court. It's part of the process and part of the system. And as you can see, whenever you go to court, there's a degree of uncertainty. Leveraging our foundations, leveraging Europe, and then seizing the significant opportunities in the U.S. has always been our strategy. So hopefully that answers your question.

If I can just ramble here, just to add to it, Craig, in the end of our press release, there's also a table where you see by region the split between generics and biosimilars. And just to reiterate, biosimilars, 3.3 billion out of our 11 billion. That 3.3 billion, 58% is from Europe, 17% is from international, which is 75% of the total, and 25% is from North America. And Europe grew 14% last year in bio. International growth 30%, correct? And on a comparable basis, the U.S. was 19%. So just to reiterate the point of Richard, correct, in the approach, also when you look at the numbers and the materiality, the weight is clearly outside the U.S. with 75% of our bio portfolio.

Thank you. Our next question is from Simon Baker from Rothschild & Co. If you'd like to unmute your line and ask your question.

Thank you for taking my question. Two if I may, please. A couple of big picture questions. Remco, you've given us a lot of quantification of the margin expansion in 26, but I just wonder qualitatively, if you could just give us an update on what's being done, what's to come, um the sort of split between mix and cost savings just a little bit of color on on how things are moving on that would be great and then a question really for both of you possibly um we can see obviously how the regulatory changes um make development more attractive and cheaper for you but i just wonder what it means for the in licensing opportunity um with lower development costs does that potentially mean others were more likely to go it alone? Or alternatively, does it mean that with those low development costs, more people are likely to try and use your global commercial infrastructure? So I just really want to see how the regulatory changes affect the in-licensing side of things. Thanks very much.

Thank you, Simon. Perhaps if I answer your second question first, I think you've answered it yourself in a way. I think that's certainly our view is, look, Yes, it's a reduction in regulatory costs, but it's still significant. You're still talking probably 80 to 100 million dollars per asset and you still need manufacturing capability. And then the bit that everybody forgets is you need a commercial footprint. in tune with the market that can leverage its scale. And that is always the thing. And a lot of companies really struggle from that clinical to commercial setup and then commercial execution. So we're seeing a significant number of partners coming to us, approaching us, wanting to work with us as a global partner. One signature, they get Europe, international Europe, strong capability and the leader in this player. So there's a lot to be said for working with us. So I very much see it as you see it in terms of that opportunity. Remco, do you want to?

Yeah. Thank you for the marketing. Let's go through the different elements. You've seen the low price erosion are relatively low with minus 3%. We still believe low to mid single-digit price erosion to remain. Of course, that also requires work. Clearly, the mix improvement with bio growing double-digit and generics low single-digit, which we expect to continue, it has a mix improvement, but also within generics. We're looking at mix improvement. That is all on track. The thing within the margin where we expect in the coming years to step up is in our cost of goods sold, that the manufacturing savings should pick up versus what you have seen so far. And that is something which we're looking forward for this year. On the DNR expenses, you have a step up of 40 basis points higher expenses. So we are above 1 billion in 2025. That you should expect to continue also in line with what Richard said before. With the golden decade ahead of us, there's so much opportunity. We want to invest in that opportunity in the right way. And with SG&A, I think we have all the opportunity to keep the increases, as I also said at the beginning, very limited. It was a minus 2% increase in 25. It was something similar in 24. And we really target to keep that very low single-digit increase also in the years to come and have that leverage with the top line moving along. We're also investing for the long term in our IT infrastructure in order to keep that SG&A and that infrastructure in place, which should also help significantly on the manufacturing side, because that can also IT-wise deliver also cost savings over the longer term. So all in all, I think we're on track with the only thing you should expect to pick up are the cost of who sold unit savings as of this year. I hope that answers your question, Simon.

Thank you. Our next question is from Urban Fritch from CKB. Please unmute your line and ask your question.

Yes, can you hear me?

Yes, we can.

Yeah, good morning. Thanks a lot for taking my question and congrats on the business progress. A couple of questions coming back to generic SEMA. So it seems like that we will see first the generic SEMA launches in India. While you're not there, my question would be, what can you learn from SEMA? from those first launches? What are you looking for in India specifically to then apply to other countries and your launches? And then a pretty open question relating to the new FDA guidance for the bisimilar approvals. How does that reshape some of those internally? What is already visible and how will it shape going forward?

First of all, thank you so much for the question. Thank you for the feedback, Urban. I guess, look, it's interesting. I mean, for me, from an Indian point of view, two things is, one, the dynamic. So how are patients willing to prepare to pay for this product? So in a sense, it almost behaves like a consumer product rather than a classic pharma product. And how elastic is that at what price point? Yeah. It's more about trying to understand the volume dynamics and the willingness of patients to pay for a product in India. And certainly early days, demand is significantly higher than the originator was selling to that market. And certainly the price points come down. And it's interesting talking to my Indian colleagues who are friends and family in India, just how many people now are wanting or acquiring that drug. The other piece is it's a complicated product. It's a supply chain. It's a cold chain product. So trying to understand how you manage the logistics of managing a high volume cold chain supply product to manage that integrity. So those are really the things that I'm looking at from an Indian point of view. And certainly it's fascinating. Regarding your second question, I don't think, I mean, look, The FDA move, I don't think it's structurally changing Sandoz. It's really thinking about how we run clinical trials and what the right data is. We've always had a good relationship with the FDA and the European regulators. And really, it's all of the regulators moving in the same direction at the same time. Because if only one regulator moved, then it would be a real challenge for us, whereas we're seeing a degree of harmonization in terms of what's expected from phase two trials, et cetera, and the low or no requirement for phase three trials. So it's really more about how we face our trials. And then. question is it's an opportunity because clearly now it's going to cost us less money to develop a biologic which means we can now develop more biologics um and given as we're about to go into a decade with something like 140 biologics coming off patent i'm incredibly excited that we can then potentially serve those millions of patients who today don't have a choice great thanks a lot thank you thank you

Our next question is from Sophia Graf Buell-Nielsen from JP Morgan. Please unmute your line and ask your question.

Good morning. Thanks for taking my questions. So firstly, how significant a growth contributor do you expect biosimilar centres in Europe to be in both 2026 and beyond? Do you expect the dynamics will differ from what we've actually seen in the US context? And then you've touched on this again in a response to a prior question, but how should we think about the pace of the ramp for Waston-Giubonti in Europe this year relative to what we've seen in the US so far? And how do your expectations differ between the oncology and osteoporosis settings for this?

Okay, so first of all, thank you so much for your question, Sophie. I mean, the Lucentis biosimilar, I mean, I guess modest. It's not the biggest launch. I mean, it's a clear and nice addition. It's not in all markets across Europe. So I think we have rights to the majority of markets because this is a co-licensed product with another party. They have the rights to Germany, which is our largest market. So I would say modest, certainly excited to be launching it for all sorts of reasons, but very pleased to be bringing that to the market for the majority of Europe and a number of international markets. And then Dano in Europe, I think it will convert quicker. Naturally, the adoption of biologics in Europe We're extremely well established. We have the relationships. I think the difference between the US and Europe is really the use in osteoporosis. Given pricing pressures in Europe, most patients were generally on things like biphosphonates. I think the opportunity now is the price points come down. to really expand and offer this for osteoporosis as a real opportunity over the next few years. So in short, I think a rapid uptake and a conversion and gain of the oncology market, and then a steady expansion and growth of the osteoporosis market. Whereas the US, I think, have a very different dynamic. Clearly there, the osteoporosis market is larger. And we're taking a significant proportion very quickly. And again, we look to expand it. And again, perhaps a little better than we anticipated in the oncology indication in terms of the conversion. So different markets, different dynamics, but performing well in both. Thank you so much. And I think with that, we will close the session. Thank you so much for your questions and look forward to interacting with you over the next few months and have a great day.