Sandoz Group Ag S/Adr

Good morning ladies and gentlemen and welcome to the Sandoz call today. I will now pass on to Craig Marks, Head of Investor Relations for his opening remarks.

Thank you and welcome to the Sandoz H1 2026 results call. Earlier today we published a media 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 Saynor, 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 the company's performance in the first half of the year, followed by an update on the business. Remco will give more detail on the financial performance. as well as a recap on guidance for 2026. Following a 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, everybody. It's a pleasure to welcome you all on the call today. Before we turn to our H1 performance, I'd like to take a moment to reflect on the growth of Sandoz. Over recent months, we've continued to strengthen our position as the global leader in affordable medicines and as an increasingly important voice in healthcare policy and medicine security. Alongside the three anniversaries shown on the slide, we're also approaching another important milestone. We are delighted that Sandoz will join the Blue Chip Swiss Market Index in September, less than three years after becoming an independent company. This is a strong recognition of our execution, our colleagues, and our growing relevance in capital markets and investor confidence in our long-term growth prospects. Please turn to slide five. Now, let's look at our performance in the first half. We delivered a strong set of results with excellent progress in our pipeline, business, and financials. We further strengthened our industry-leading biosimilar pipeline through the addition of four in-house assets, bringing our total biosimilar pipeline to up to 36 assets. We also achieved important regulatory milestones, including EU approvals for our insulin biosimilars and US regulatory submission acceptance for our in-house generic tithapotide. In addition, we received regulatory approval for a new semi-glutide treatment option in Brazil, paving the way to expand patient access in this important market. From a business perspective, we continued to leverage our scale and competitive advantages. We moved up to become the number two biosimilar and generic company in North America. We opened our new state-of-the-art biosimilar development center in Ljubljana, and our climate targets were validated by the Science-Based Targets Initiative. These achievements were matched by a strong financial performance that was in line with our commitments. In the first half, net sales increased by 5%, including 7% growth in Q2. Buy-similars reached a record 33% of net sales in the half, while our core EBITDA margin expanded by 90 basis points to 20.9. Management-free cash flow remained strong at around $500 million, despite a significant uplift in capex. Based on our performance in the first half and our confidence in the outlook for the remainder of the year, we are confirming our 2026 guidance today. Taken together, this outlook and these achievements reflect the strength of our business model and our ability to translate execution into sustainable growth and value creation. Now, let's look at the sales performance in more detail, starting with slide six. H1 was another period of strong growth for Sandoz, with top-line momentum led by an outstanding biosimilars performance. Indeed, biosimilars grew by 20% in the first half, increasing to 22% in Q2. We continue to benefit from successful launches and excellent commercial execution across every region. Generics also gained momentum from Q1 into Q2. The modest decline in the first half was largely a result of temporary headwinds in the first quarter, including adverse dynamics in the anti-infectious B2B business. In Q2, low single-digit growth for generics was more in line with the long-term trend. Please turn to slide 7. While biosimilars are the key growth engine for our business, generics are a strong and essential foundation for sustainable growth. Providing stability, access scale, and reliable cash generation to support our long-term strategy. For the period 27 to 36, we have over 300 assets in the generics pipeline, targeting two-thirds of the loss of exclusivity opportunities by value. Our portfolio strategy remains highly disciplined. We focus on the most attractive LOE opportunities, particularly in oral solids and injectables, where our scale, Development capabilities and commercial footprint provide meaningful competitive advantages. At the same time, we continue to convert our generics pipeline into commercial launches. Recent examples for Europe and the US are shown on this slide. We are also making important progress in GLP-1s. In Brazil, Anvisa recently approved Sandoz's first GLP-1 medicine. with the launch of semaglutide planned for later this year. This represents a historic milestone for us, establishing our presence in the GLP-1 market and providing access to one of the world's largest semaglutide markets. Together with our multi-source strategy, this strengthens our ability to participate in what we believe will be one of the most significant growth opportunities in healthcare over the coming years. Now, let's turn to Bioslimmers on slide eight. Starting with Hyramoz, we continue to hold leading positions. Alongside an expansion of biosimilar adoption, we have grown our global market share, and I was pleased to see Hyramoz delivering double-digit net sales growth in the first hour. Turning to Peacejiva, we have quickly established a leadership position in the European Oosterkinnemat market. Today, Peacejiva is the number one biosimilar across major European markets, with a 35% market share. It also grew double digit in the first half. While short-term market dynamics in Germany have created some headwinds for Peace Jiva and Biosimilar pricing more broadly, the underlying performance of our Biosimilars clearly remains very strong. Please turn to slide nine. Let me now turn to Tyruco and Omnitrope We continue to make encouraging progress with Tyruco in the European Nataluzumab market, with market share increasing from 7% at launch to 17% today. Importantly, that share has remained stable over the last few quarters. Looking ahead, we see potential upside from further adoption in Europe, a longer-term ramp-up in the US, and additional launches across Europe and international markets. 2026 marks the 20th anniversary of our first regulatory approval of Omnitro as the world's first biosimilar. Today, it remains the class leader, with a consistently strong market share of more than one third. Please turn to slide 10. Now, let's move on to our most recent growth drivers, starting with Wyest and Jubonti, where the launches have exceeded expectations. In the US, both medicines have quickly established leadership positions after the launch in Q2 last year, with Gibonte achieving a 64% by a similar market share and Waiost 54%. These results reflect broad provider access, strong commercial execution and early wins with key players. The European launch has also been progressing exceptionally well, with rollouts completed across 27 countries on day one, whilst international launches in markets such as Brazil and Australia are also gaining momentum. Turning to Afclare, our Aflibisep biosimilar were equally encouraged. Launch execution across Europe has been strong, and the medicine is now available in 19 markets. With limited competition today, AFCLIR is well positioned to drive broader patient access while supporting more sustainable healthcare systems. Looking ahead, AFCLIR represents another meaningful growth opportunity in 2027 and 2028, supported by US launches in the coming months. Please turn to slide 11. This slide highlights the depth, quality, and scale of our industry-leading biosimilar pipeline. I'm very proud of the progress that we're making. Our biosimilar pipeline now stands at 36 assets. This breadth is unmatched in the industry and provides multiple future growth opportunities across a wide range of therapy areas. Importantly, this is not just about the size of the pipeline. What differentiates Sandoz is our ability to continue to expand our pipeline and convert assets into successful commercial launches. This is creating an increasingly attractive portfolio of market-leading biosimilars. Today, we have five assets either in regulatory review or are yet to launch, six assets in clinical development, and 10 in technical development, with a further 15 in early development. The shape and expansion of this biosimilar pipeline underpin our increasing confidence in the Sandals roadmap. We have multiple assets entering late-stage development A growing number of regulatory milestones ahead and a broad set of future launch opportunities that support our ambitions for the Sandoz Golden Decade. Beyond the medicines we have in the market today, we are investing to ensure we are the leader of the next wave of biosimilar growth. One of the key milestones in the first half was the opening of our new state-of-the-art Biosimilar Development Center in Ljubljana, Slovenia. More than simply a new facility, it is a strategic investment in scientific and technical capabilities that all support our industry-leading pipeline and long-term growth ambitions. It is a huge step up in our development capabilities, and we look forward to showcasing the center to many of you in November. As our biosimilar pipeline becomes larger and more complex, speed, efficiency, and execution become critical competitive differentiators. This center strengthens all three Alongside our growing commercial scale, the benefits of this investment give us greater confidence in our ability to deliver a leading program of launches and capture significant growth opportunities over the coming years. And with that, I will hand over to Remco on slide 13.

Thank you, Richard. And hello, everyone. Please turn to slide 14. Let me start with our strong first half performance. which demonstrate the strength of the Sonders model and our disciplined execution. In the first half, 5% increase in net sales was driven by the very strong performance of biosimilars where sales grew by 20%. This growth was broad-based. All regions contributed with strong results from legacy biosimilars as well as the recent launches. We continued to make excellent progress on profitable growth Core EBITDA increased by 15% and the margin expanded by 90 basis points to 20.9%, supported by an increasingly favorable sales mix, continued operational efficiencies, and operating leverage. The combination of higher operating profitability and stronger core net income drove a 17% increase in core diluted EPS to $1.71. Demonstrating our ability to convert top-line growth into higher earnings growth. At the same time, our cash profile remained strong. Management free cash flow was stable at 503 million US dollars despite additional capital investments to support future growth. Please turn to slide 15. Net sales increased by 10% in US dollars or 5% at constant currencies. taking sales from US$5.2 billion in H1 last year to US$5.8 billion this time. The performance reflected significant volume growth. Biosimilars were the standout contributor. In North America, biosimilar sales grew by 47%, while Europe and international markets also delivered double-digit biosimilar growth. The impact of price erosion was more than offset by strong underlying demand and Enhanced Market Access. The level of erosion primarily reflected shorter market dynamics in Germany and an outstanding buy symbol performance in North America. Currency movements provided the five percentage points tailwind in the first half and touch on our full year expectations in a moment. Please turn to slide 16. Alongside the rapid growth of biosimilars, generics remain a resilient foundation of the business. H1 generic sales were broadly stable, with the performance improving meaningfully in Q2 after one-time headwinds in the first quarter. While residual headwinds remain in generics in the international region, driven by active portfolio regionalization and market dynamics in Brazil and Japan, The Q2 improvement reinforces our confidence in the trajectory of the business and the sustainability of our growth outlook. Please turn to slide 17. Looking at the regions, North America delivered a particularly strong performance, growing by 15% in H1 and even by 18% in Q2. This was mainly driven by the successful launches of Weis and Ubonte, which continue to exceed our expectations and illustrates the commercial potential of our biosimilars platform. European biosimilars were also up double digits while the generics business returned to growth in the second quarter. And international biosimilars continued to gain traction with growth of 19% supported by Rixaton and recent launches. Now let's have a look at the P&L on slide 18. Topline growth was supported by strong buyer-similar momentum and an increasingly favorable sales mix. This helped lift the core gross profit margin to 49.7%, an increase of 50 basis points. At the same time, we generated further operating leverage, supporting a 90 basis point expansion in the core EBITDA margin to 20.9%. Importantly, we achieved these margin expansions while continuing to invest in our pipeline, launches, and future growth opportunities. With core diluted EPS increasing by 17% to US$1.71, we delivered a more profitable growth, combining strong commercial execution with disciplined cost management and increasing operating leverage. Please turn to slide 19. As I mentioned, a number of factors helped to grow the core EBITDA margin. The most significant contributor was business mix. Strong double digits by similar growth increased the share of accretive medicines in our portfolio, contributing around two percentage points to margin expansion. While price erosion is a constant headwind, this was almost offset by continued operating efficiencies, including in manufacturing and supply, as well as support functions. Currency movements continue to have no material impact on our operating margins. Let's now have a look at one-off costs on slide 20. Excluding litigation and some IT expenditures, we had one-off costs of 142 million US dollars in the first half. I continue to expect these one-off costs to amount to around 0.3 billion US dollars over the full year. in line with my previous commentary. Importantly, these costs are trending down significantly from the peak in 2024 as the major separation activities move towards completion. Outside of underlying runoff costs, we announced this week another important step in addressing legacy US generic drug litigation. We have resolved all pending class actions in the US generic antitrust litigation as well as all claims filed by any U.S. federal or state government against the company. The only remaining antitrust claims against the company in the U.S. generic antitrust litigation are those brought by individual plaintiffs who opted out of class settlement. We reached a settlement agreement with 43 U.S. states and territories covering 400 million U.S. dollars spread cash-wise equally over seven years starting in 2027. Resolving all federal and governmental claims. The resolution of these claims requires an additional payment of approximately 50 million US dollars to states that settled earlier. We also entered into a settlement agreement with a putative class of indirect reseller plaintiffs and will therefore pay 28.5 million US dollars in exchange for a full release of all claims. These settlements reflect our commitment to operating with integrity, maintaining strong governance and responsibly resolving legacy matters as we continue to work to expand access to affordable medicines. These settlements do not affect our full year 2026 guidance or midterm output. Please turn to slide 21. Turning to cash, the strong operating performance translated This was achieved despite a meaningful step up in CapEx to around $500 million, as well as higher interest and tax payments, demonstrating the underlying working capital resilience of the business. Be aware that higher interest expense in the first half mainly reflects the coupon payments in March 2026 on recently issued bonds. We continue to expect CAPEX to peak during the current investment cycle this year at around 1.1 billion USD. These are deliberate investments to support our future growth, and the performance of management-free cash flow underlines the resilience and cash-generative nature of our business model. Please turn to slide 22. Our balance sheet remains strong. and provide significant financial flexibilities to support both growth investments and disciplined capital allocation. During the first half, we further strengthened our liquidity position to 2.3 billion US dollars, supported by successful Swiss bond issuance in April earlier this year. Gross debt increased to 5.9 billion US dollars. Strong cash generation, however, largely offset its impact, leaving net debt broadly unchanged at 3.5 billion US dollars. This meant a net debt to core habitat ratio of 1.4 times at the end of the period, down from 1.5 times at the end of last year. Our strengthened balance sheet, improving liquidity and investment grade rating puts us in an excellent financial position to support our ambitions. Please turn to slide 23. We continue to maintain investment grade ratings for S&P and Moody's with both having positive outlooks on Sandoz. Our debt maturity profile is well diversified with an average maturity of around five years, while our average borrowing costs remain below 4%. At the same time, we remain disciplined on leverage, targeting net debt to core EBITDA below two times in the medium term. This combination of financial strength, flexibility, and disciplined capital allocation ensures we can continue investing for growth while maintaining an attractive risk profile and delivering value to our shareholders. Please turn to slide 24. And now finally, let's recap on the guidance for the full year. We continue to expect net sales to grow by a mid to high single digit percentage of constant currencies, supported by the positive impact of recent launches. The core EBITDA margin is targeted to increase by around 100 basis points. We now expect overall pricing to decline by a mid-single-digit percentage in 2026, compared with our previous expectation of a low to mid-single-digit percentage decline. This reflects the near-term dynamics in Germany and North America I mentioned earlier. Outside of guidance, we now anticipate a 2 percentage point tailwind to net sales from currency movement this year, based on recent spot rates and average rates in the period. Our prior assumption was a 4 percentage point tailwind. We still do not expect a material impact from currency movements on the core EBITDA margin this year. Looking beyond this year, we remain highly confident in the outlook for Sandoz in both 2027 and 2028. Recent launches will continue to contribute more meaningfully, and we have a strong pipeline of biosimilar and generic launches ahead. including the rollout of GOP1 in early markets. Importantly, our multi-source GOP1 strategy positions as well to capture this significant market opportunity. With strong business fundamentals and clear visibility on our growth drivers, we are very confident in what Sandoz can achieve. And with that, I'll hand back to Richard. Please turn to slide 25.

Thank you so much, Remco. I'd now like to wrap up the presentation before we go to questions. Please turn to slide 26. To conclude, our business continues to perform strongly across pipeline execution, market position, capability building, and financial performance. We further strengthened our biosimilar pipeline, which now comprises 36 assets, whilst also achieving important regulatory milestones. And we received our first GLP-1 approval A historic milestone for Sandoz. We moved up to become the number two provider of affordable medicines in North America, and I am delighted that we have now opened our state of the art by a similar development center in Ljubljana, further strengthening our long-term development capabilities. Financially, we delivered strong growth, core EBITDA margin expansion, and robust cash generation. And based on our performance in the first half Our confidence in the remainder of the year, we are confirming our full year 2026 guidance today. Taken together, these achievements demonstrate the strength of our business, the momentum across our platforms, and our ability to create sustainable value whilst continuing to pioneer access for patients worldwide. Please turn to page 27. As we look forward, we are focused on delivering sustainable growth and creating value for patients. We're excited by the opportunity to share more about this and our golden decade for biosimilars with you at our Capital Markets Day on the 8th of September in London. Thank you again for listening. Please turn to slide 28 and I will ask the operator to open the lines for Q&A.

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 a question. If you want to withdraw your question, please lower your hand using the raised hand function in the Zoom app or via telephone, press star 9. Thank you and a moment for the first question, please. Our first question comes from Sophia Graf Bull-Nielsen at JPMorgan. Please unmute your line.

Good morning, thanks for taking my questions. Just one on AFCLIR in Europe. Where are you seeing most of the volume come from? Is it mostly from the originator or competitor brands or are you seeing significant uptake in naive patients? And then just what is your expectation for how that volume opportunity might develop or be limited as the originator converts patients to the high dose formulation? I think they were saying yesterday they expect 70% of volume to be on the high dose by the end of the year. and then just on Waston Gibonte in Europe as well. How are you seeing biosimilar market share penetration progress in Europe relative to what we saw in the US for Sandoz? And have you been able to establish a clear lead as you did in the US? Or is the volume competition a lot closer amongst biosimilar peers in Europe? Thank you.

Thank you and good morning. Thank you so much for your question, Sophia. AFCLIR, I mean, look, we're seeing very strong uptake I think what you've seen we clearly took a very strong position in terms of our patent strategy and I think we've been rewarded from that. I really don't you know and really it's a bit early today we need to see the IQVIA data but certainly we're seeing strong uptake broadly in all of the markets that we've launched and I don't really see a massive I mean clearly some patients will migrate to high dose but also this is an opportunity to offer far more patients This medication, so this was in a very expensive medication. So what we're seeing is players in Europe using this as an opportunity to drive access. So it actually goes back to a very core purpose as a company. And similarly, Wyerson-Giubonti, yes, we've taken a very strong lead. I think we're by far the largest player in Europe. Again, we're yet to see the most recent IQVIA data, but very pleased with the performance and uptake of the product.

Our next question comes from Victor Flock at BNP Paribas. Please unmute your line.

Hi, thanks so much for taking my question. Maybe one for Richard on potential U.S. tariff. I believe you flagged this morning constructive dialogue with the U.S. administration and openness to expand your manufacturing capabilities beyond Slovenia, I guess. So should we read that as a commitment to U.S. capex? And should we assume that you need both generics and biosimilar capabilities on the ground locally to comply with U.S. demands? Thank you very much.

Good morning. Thank you, Victor. Yeah, look, I mean, I think as I said this morning, we have a very open dialogue with the administration. I was in Washington actually two weeks ago. I met with quite a number of senior members of the cabinet. I do see opportunities. I think it's too early to say what that would look like. We've always said, look, yeah, I think we're broadly aligned to the US administration. We want to find ways to bring affordable medicines to US patients. Yeah, and I think that's the dialogue that we need to have now. And I think certainly we're talking, I think we want the same thing and I'm optimistic it's way too early to say what that would look like. And so I wouldn't, I couldn't comment on what the specifics would look like, but certainly based on the conversations, I'm very optimistic.

Our next question comes from Charlie Hayward at Bank of America. Please unmute your line.

Hi Charlie Hayward, Bank of America. Thanks for taking the questions. I have one on SEMA and one on ILEA please. So first on SEMA, I know you didn't want to commit too much before approval and it's not part of your 26 guide, but I think some more positive commentary out of yourselves today. So now that you have one approval and potentially decent visibility on the Canada approval, how are you thinking about that potential contribution 27-28? And then on ILEA US launch in fourth quarter, you've got a competitor annualizing at a billion sales, and then you're likely third to market with four or five more coming by the end of 1Q27. And you're clearly excited to see it as well. So what could you point to to help us understand potential differentiation there? Is this dosing device access contracts and any market proxies that you would flag where you've been a long way behind an original player that's formed the buyer's market and you've quickly gained market share? Thank you.

Thank you, thank you, Charlie. Yeah, look, clearly we're pleased with the approval in Brazil. I think certainly for 2026, we never said it would be particularly material, but I think it's a step in the right direction. And we still have the ambition that we would launch in Canada this year as well. It becomes more interesting as you get into 2027, and I guess it's sort of Clearly, we would launch in Brazil. We expect a number of the other international markets, markets like Turkey, et cetera, and clearly Canada flowing through into 27, so it becomes more material and meaningful as we go into 27 and 28. As we've talked many times, it's actually a very difficult product to characterize in terms of how the market will expand, but certainly we're pleased to be participating and excited to be moving forward. In terms of ILEA, I think the key here is We have a phenomenal relationship. Remember, we bought the ophthalmology capability a couple of years ago, really with this product very much in mind. So we have the relationship with the payers and we're well established. I can give you numerous examples where we weren't Thank you very much. Certainly I think it's an attractive opportunity and I think we're very well placed to position the product.

Our next question comes from Sian Cotidier at Goldman Sachs. Please unmute your line.

Hi there, thank you for taking my questions. Just circling back onto the GLP-1 opportunity in Brazil, so you got the approval. I wanted to check if you could provide a little bit more colour on the commercial dynamics, given that there's around five to six players, including Novo's rebranded version that's now approved. It seems like price erosion is more steep than initial expectations, so can volumes offset that? So any colour there would be great, as well as commercials with Adalvo in terms of a profit share, royalties, any colour there would be great. and then my second question is on the other revenues line item. This came in below expectations and looking at the half year report, it seems as though this was due to hardly any profit sharing income. I believe this might relate to Piskiba in the US through your collab with Samsung. So can you talk through what's happening here? Is there some sort of phasing that would unwind in the second half? Thank you.

Okay, thank you, Shane. GLP-1, it's too early to say. I think, look, it's going to be a dynamic market. I think we've always said in a This is an underserved opportunity. Clearly, we have a strategy as we enter that. I think let's get into the market. It'd be something we'll talk about many quarters ahead. I don't really want to disclose our strategy or how I see that market will evolve and make our competition any harder. So let's see, but clearly pleased that we're there. And I think we're now pretty much the only international generic company coming into that market at this point. So we have a strong brand and a strong relationship. And so let's see. I think other revenue, I was just looking at Remco, I'm not sure if you want to comment, Remco, but we might wait.

I think with regard to your question with the profit sharing, etc., there's nothing particular which has happened in H1. I don't have so quickly the answer on the other revenue movement, but there's nothing special to be considered in H1 versus what there was before. There are no major changes.

Thank you.

Our next question comes from Simon Baker at Rothschild & Co Redburn. Please unmute your line.

Thank you for taking my questions. Two for me. Another one just continuing on the SEMU in Brazil theme. About half that market is, we understand, compounded product. I just wanted to give any thoughts on how that affects the dynamic. Does that affect price or will quality? and more broadly on Semo and indeed Tazepatide, Lily and Waters were recently commenting that establishing purity of these chemically synthesized peptides is far from trivial. I don't see that as an issue for Sandoz, but it could be an issue for some of your competitors. So I just wondered if you could The update is on the quality, quantity and sourcing of your peptides in this space. And then secondly, a slightly bigger picture question. As we see repeatedly in this presentation and previous ones, It looks like the market tends to underestimate the longevity of opportunity for an individual buyer similar, that your share stays stable, penetration increases. So I'm just trying to get an idea, and I'm sure this is something you'll discuss more at the CMD, about how long we should think about the duration. Time to peak may not be quite the right phrase, but it feels like it is a multi-year opportunity and some color on what multi-year looks like. If indeed there is one can generalize would be really helpful. Thank you so much.

Thank you so much for your question, Simon. And I think I couldn't have put it better myself. So I'll come back to the moment. Look, semaglutide, I think the compounding in a sense, why is compounding there? It's a reflection that the patients want this product at a lower price point. I think in many ways, with the entry of generics or copies of this product, I think a lot of the compounding will disappear because, quite frankly, the economics don't make sense. You want to have the security of a fully manufactured product and the appropriate supply chain. So I think, actually, I see that as an indication of the opportunity and I expect it to erode pretty quickly as generics enter the market and convert it. Your comments made me smile. I mean, I've been in the industry a very long time. Every originator right from the first original generics has been going around saying generics are poor quality. And then we had that same with biosimilars that how can a biosimilar be the same? I'm sorry, it's the same old shtick that originators always try and disparage this industry. You know, I'm comfortable with the product. I stand behind the products on our quality. And I think it's just a normal response from originators who are desperately trying to hang on to legacy products and legacy shares. So it's not something that unduly concerns me. And I love your question around longevity. This year, Sandoz launched its first ever buyer similar. We created this market as it were. We launched Omnitrope 20 years ago. Today, Omnitrope is still one of our largest products. We are still the leader in that share. and this markets don't go away and I think it's very hard to say what is that longevity but you know I can with it's a high degree of confidence say well no one's ever likely to launch another biosimilar to human growth hormone so patients will need those products and similarly with a lot of the portfolio we have unlike small commodities small molecule commodity generics absolutely there's a very long life cycle and I think that goes back to the fundamentals of the investment case around Sandoz because we bring more biosimilars to the marketplace They're accretive and they continue to deliver year after year. And we're all broadening that portfolio. So again, I think you're right. We will touch on that at the CMD, but I think we're extremely well positioned. And that's exactly why I keep saying this is Sandoz's golden decade as we look forward over the next 10 years.

Richard, if I may add to it, we are often being looked at as an individual biosimilar-biosimilar case. We're not an originator with a few biosimilars. It becomes a whole portfolio together. And there's also no end date. With an originator, there's an end date. For us, there's no end date, which is also forgotten in the equation. If I can add those two things, Richard.

Thanks so much. Very helpful.

Our next question comes from Harry Sefton at RBC. Please unmute your line.

Brilliant. Thank you very much for taking the questions. The first one is on pricing and you called out in your guidance that you're seeing price erosion step up to the mid single digit level rather than low to mid. Can you maybe just expand on that and where you're seeing that pricing and your ability to offset that with volume gains? And then my second question on Denosumab US, it appears that that continues to be a very strong tailwind for you in the US. What is your expectation for the continued market share gains in the second half, and what are you seeing on pricing? It looks like the originator has been a bit more aggressive on rebating there, so any help on the pricing side would be helpful. Thank you.

Remco, do you want to pick the pricing up? Yes, I picked it up. There are two elements which play a role. One, the success in North America. That, of course, sounds strange, the high price erosion, but the bio grows really, really fast in the US, and particularly the early launches attract a relatively higher price erosion percentage. It still doesn't mean that the product isn't profitable because pricing relatively starts high, and then you'll have a steeper price erosion. Now, with that high growth, you've seen a 47%. proportionally it attracts a bit more and more price erosion but indeed the growth which is behind it is more than offsetting it. Second was Germany. Germany at the beginning of the year there were some new pharma substitution rules introduced for the biosimilars for which some tenders came in. They're stopping now through 28 and they're re-looking at it. On the other hand in Germany we had a fabulous growth as well on the volume side so it's more than offsetting it. We are not worried. We see this tendency in different markets around Europe and around the world. So it's a normal part of our business. So we don't see any impact on nor the profitability nor the top line as well. So our guidance is completely unchanged. So for us, nothing special, although I understand it attracts a little bit your attention.

And then on Denosum, I mean, clearly we're going to lap ourselves. So the growth rates naturally will slow down, but we still see good share gains. So I still see it as a growth driver in the second half. And I'm sorry, you know, I've been again, my comment earlier, I've been in generics a long time, originators always fight to try and keep share. It always ends up being a zero sum game for them because their business models are very, very different. You could argue that every single The originators claim that they can defend and they take aggressive pricing. In the end, the industry normally wins out as a generics and biosimilars. So I don't see anything unusual in terms of what they are doing. And I'm clearly delighted that we've taken such a strong leadership position in the US with quite strong competition and still see some growth potential in the second half.

Our next question comes from James Gordon at Barclays. Please unmute your line.

Hello, James Gordon from Barclays. Thanks for taking the questions. A couple of questions, please. One was on Germany. So there have been these headlines about healthcare spending cuts, which you mentioned, and short-term market dynamics. But so is your understanding it's just a one-off hit on biosimilars and then pricing goes back to normal? How will pricing work beyond this? Could there be a longer-term headwind for what you charge for biosimilars in Germany? And do you think there might be any offset in terms of if Germany is trying to save money, could there be more spending on generics and biosimilars as some volume benefit? Or is Germany just going to be a tougher market? Second one was just a clarification on Sema and Cananda where I think you said you hope to be approved by the end of the year. Do you think you're just going to be the one-mig dose or the two-mig dose? Because I think that the approvals so far haven't been the full dose range. And if it's not the full dose range, does that maturely reduce the opportunity because patients want to have the full dose range with the innovator? And then just quickly, finally, would be gross margin. So you're up 50 bps year on year, which look good. But do you think you are going to get much more margin expansion from gross EBITDA margin expansion from gross margin when we're hearing about pricing pressure in Europe and tariffs and in-licensed products with payaways? Is the margin expansion going to be much more about SG&A leverage and gross margin more modest? Or do you think you're going to start to see a step up in gross margin expansion even ahead of Slovenia coming in?

So, Remco, do you want to take the first and third question? Sorry, thank you, James. Thank you for your questions. And then I'll take this, Emma.

James, good to hear your voice again. Good morning to you. Indeed, for Germany, we see this for the moment only as an implication for 26. The standards have continued for 27, 28. Germany is relooking at the process here. Clearly, to save money in the healthcare systems, you need more generics and biosimilars, right? And as that participation of us in the market grows faster, it clearly has a benefit. Germany has different channels. The Tenders is one of them. The Tenders have also big opportunities with regard to volume. We've become a larger player. We can provide also the volume. So these dynamics are something which we see in every market in Europe and we will deal with it. But for the moment, We don't see the price erosion we have seen now in Germany in 26 to continue in 27. We don't see that. On the last question, we see the EBITDA margin improvement to continue year on year through different dynamics. One is the biosimilar part of the portfolio to keep on growing and biosimilars have on average a higher margin. That trend will not change. Secondly, the recovery on our fixed cost structure will still help us in the leverage of the cost. The mix between gross margin and TFC that will vary depending year on year, quarter on quarter of the different dynamics. But both of them will play a role also in the coming years ahead. That's part of our midterm guidance. And I have to say very boringly, it's the same story and nothing has changed here. Richard, over to you for the second.

Yeah, thank you so much. On SEMA, we've not disclosed what presentations. Again, we still have the ambition that we will get an approval and launch in Canada this year. It's also worth pointing out, we're not dependent on one partner, we have a numerous partner strategy. So it gives us more capacity, it gives us more flexibility. And it gives us better confidence in terms of our ability to supply this market. Also bear in mind in Canada, we're in a very strong position, we have an extremely Our next question comes from James Vane Tempest at Jefferies. Please unmute your line by pressing star six and ask your question.

Hi, thanks for taking my questions. Two, if I can, please. It's James and Jeffrey's. I'll leave with the first one and then come with a follow-up. You talked more about there's some negative pricing of mid-single-digit from low to mid. I mean, there's been questions already on Germany, but I was sort of wondering, thinking about buyers' similars, are there any particular you're having to discount more to win share versus what you previously thought, just to kind of raise the pricing pressure this first part of the year?

Nothing more particularly to mention than North America, which always has a higher price erosion when we launch, and just the sheer volume of it makes it in the mix having a bigger impact. Germany, I just explained as well, there's nothing else which is there. You still have to keep in mind there's such a focus on this relatively price erosion which is a bit weird on balance because we look of course at the mix and the profitability on a product by product level and biosimilars are very profitable or let's say more profitable than the generics as part of the portfolio. So we look more at the mix of the products we sell and the profitability of that mix and clearly that's improving. You see that also in our gross margin where we have the The 200 basis points improvement year on year in our profitability. And that's something we expect to continue also in the coming years. So also with what Richard said that before the outlook for 27 and 28, we see a good volume growth. We see this mix to continue in the P&L and therefore we have also a very positive outlook on the profitability and that we expect the margin to continue.

Thank you for your comments on Germany. I mean first obviously this only relates to the SIG funds and actually that the law that was driving substitution has been reversed. I think eventually substitution will arrive in Germany but actually I'm net positive. You look at our pipeline, the depth and breadth of our pipeline means that as we bring more modest sized biologics to the market we see much more rapid uptake and penetration. So actually I could argue It's net benefit to the company overall, and clearly, I think, given the overall strength in the German market. And as Remco says, I tend to not over-index relative price erosions. I know we get a lot of questions, and I understand why. But it's not something I look at so much, because as we launch more biologics, you're naturally starting from a much higher starting point, and you're always going to discount percentage-wise much more. It doesn't materialize when it flows through to the P&L, but I know you all look at it and model it, but I look at it slightly differently.

Thank you. And then just to follow up on your guidance construct and particularly thinking about phasing for this year, business clearly accelerating into Q to 7%. But if we think about then momentum as we move through Q3 and Q4, is an exit rate of 10% reasonable this year, just given the acceleration and the new launches ramping up? and then related to margins you know around 100 basis points and you've done 90 in the first half you know with this sort of momentum you've got in the second half you know what would you needed to have seen to perhaps change this from around 100 basis points to greater than 100 basis points just to sort of help us understand what held you back there uh or is that how we should really be thinking about it this year thank you thank you so much James I'll let Remco answer that James very very very fair questions

What we have said before and also at the beginning of the year, we believe first of all that H2 will have a higher growth than H1, which is of course not a surprise because to end on or mid to high, that is higher than the 5% without quantifying that exactly. So we need to come with a higher point in H2, which we clearly have on the radar screen. But still have to be seen if you think about the phasing in H2 that we expect to be Q4 to be higher than Q3. Something similar as we have seen in H1 between Q1 and Q2. We also have to keep in mind that in Q3 we still expect some headwind from the anti-infectives, which is that we had some anti-infectives headwind in Q1. In Q2, we didn't have much, but there is still some impact of that in Q3, which also makes the Q3 top line growth a little bit lower, although underlying in the quality of the sales, it is there. And then at Q4, we expect a further step up. So we come to the mid to high. I can't comment on an exact percentage, right? That's not how we give the guidance, so sorry about that. With regard to the profitability, Indeed, if you want to come 100 for the full year, it's 90 in H1. The average would be then 110 in H2. We clearly stand behind that. I'd be very confident on the current trend, the way the business is going, the mix is going, that we can make again that step up in line with our commitment. And by the way, that's not something we only expect in 27. Our midterm guidance for 28 stands there in full. So the 24 to 26% stand. So also that trend we expect to continue in each of the coming years. So it's not only a 26, it's also a 27, also a 28. Thank you.

Our next question comes from Nicholas Palak at Kepler Shalhoub. Please unmute your line.

Hi guys, thanks for taking my question. Maybe just a quick follow-up on what was asked before on the long-term profitability of Bioseminar. It would be interesting to have your view on what's this time instead of the revenue generation, What are the profitability of this biosimilar as time passed on? Because I would assume that the competition reduced and so do you get some leverage maybe on HDNA or things like that on this product? And then also when you say that you are looking at the let's say golden decade and so adding new layer of growth on this biosimilar division, is there a point in which you see that there might be some Let me take you a little bit to a higher level, if I may. So we have a generics and a biosimilar business.

They're very synergetic. So the advantage we have with a very high generics business is that we have an infrastructure, commercially, but also for our overhead, our G&A, which we can fully leverage. So it's not that biosimilar attracts a different kind of commercial cost on top of or extra general and administrative cost. And this is a bit of the really good position we have versus any If you start only with biosimilars, you don't have that big infrastructure which you can leverage, which we can. So the margin improvement you have to see over the coming years comes again from biosimilars being a larger part of the portfolio and having on average a higher margin and the whole infrastructure which we can further leverage and also we are driving productivity in different angles. Now what later of course comes with the infrastructure we have with what we all built in Slovenia, You get also that benefit of the full vertical integration over the coming years. And then we get new bio in the portfolio where probably we will have less competition. So all that equation makes us very, very positive over the years to come. And with now quite a nice portfolio of products with 36 in, 13 launched in the market, And there's so much opportunity, correct? We know that with the 650 billion of LOE over the coming 10 years, that can only grow further. And we have a great infrastructure to leverage. And percentage-wise, we also shouldn't forget the faster biosimilar growth, the larger part it becomes of the portfolio. So the average growth will also for the group go up, correct, in the total. So it's all reinforcing it together.

If you then think about the golden decade, I think it's always a little bit counterintuitive, but actually the competitive intensity is going down, not going up. So you've got something like 100 biologics coming on patent in the next 10 years. So the average number of competitors per biologic is maybe one or two. And so, yes, everyone is focused on the denosumabs and the pembros. And we've seen 10 players in denosumab. And I think we've demonstrated our capability to win in those sorts of markets. But also now you see some of the more modest size LOEs, maybe $2 and $3 billion. But we just don't see any competitors or very, very few competitors. So I think leveraging our scale, leveraging that. And I think the other part of your question is that the infrastructure, and Remco touched on it, but broadly we're investing now in capacity in terms of manufacturing, both fed back, large and small, and the continuous manufacturing platforms that we have in France. gives us really the optionality to supply that network. So I think we're in such a nice position with this combination of mature assets and then this strengthening opportunity as we look into our golden decade, which is why we describe this as Sandoz's golden decade, not the industry's golden decade.

Our last question comes from Florence Cespedes at Oddo VHF. Please unmute your line.

Thank you very much for taking my questions. Two quick ones if I may.

First from Remco regarding the slide 20 and the one-offs. Could you have a look

The software costs as well. And regarding the underlying one of costs, we understand that it's clear that you have reiterated that you will record $0.3 billion costs this year. But how should we think about this underlying one of costs going forward? Is it fair to assume that the transformation will be Stable or separation will go down. So any color on this one would be great. And my second question, that's a big picture question for Richard. When we look at the pipeline, the assets on the pipeline, most of the long-term projects are in-house. So is it fair to assume that going forward, this will have a positive impact on the product mix and on the margin? Thank you very much Remco, I'll let you go first and then I'll close.

Thank you, Florent, for this question. First on the underlying one-offs. About 150 million in H1. We guided for the full year around 300 million. We still stand behind that. So nothing changed. And we expect as well in 27 that to go further down, correct, in line with the guidance we have given. So there we deliver exactly what we said. Software has to do with a bit of the strange accounting rules around SAP in the cloud, where somehow that cannot be capitalized and aligned with other companies. The fact that we can't capitalize, we show it separately. It's a similar number for the full year as it'd be last year with our SAP introduction. And that will also remain for the coming years whilst we complete that software upgrade with our SAP systems. The legal element, you have to remind that it's a legacy. It's something which comes from more than 50 years ago. That was also from our predecessors when we were cleaning up that mess. Age one is the big impact and we don't expect at this point in time any material impact in age two.

And thank you for your final question. I think you're absolutely right. Clearly, a larger proportion of our pipeline will come from our own in-house network. I wouldn't say it's an and rather than an all. So clearly, we are really the partner of choice in this industry because we can give share, we have this capability. And also, I think it will increasingly become a moat. It's interesting, a lot of companies claim to be via similar companies, but quite frankly, just in licensing a few products doesn't make you a via similar company. In fact, we have a broad capability in terms of technical development, manufacturing, legal, commercial, really means we are in such a unique position to leverage these huge opportunities as we look forward. So I'm very pleased to see our pipeline expanding. I would still look to continue to work with partners, and that means that we can service more and more portions. But you're absolutely right, clearly it will gain, it's another positive impact Thank you so much. It's been a pleasure to give you our Our performance for H1, I look forward to seeing many of you in London at the Capital Markets Day. Look forward then to giving you more clarity about how we see the business coming. Hopefully you got a sense in terms of our confidence of the business in the second half of this year and also particularly our confidence as we go into 27 and 28. Thank you so much for giving us our time today and good day.