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. Welcome to the Sandoz Q1 2026 Sales Update. 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/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 sales 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 Q1, followed by an update on the business. Remco will give more detail on the net sales performance, as well as guidance for 2026. Following the wrap-up of the presentation, we'll be happy to take your questions. 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. 2026 is a landmark year for Sandoz as we celebrate three milestones that tell the story of affordable medicines. This month, we marked the first of these. 20 years ago, Omnitrope was approved in Europe as the world's first ever biosimilar. With this approval, Sandoz didn't just develop a medicine, we pioneered a new industry and laid the foundation for expanding patient access to vital biologics worldwide. We continue to build on that strong legacy, drawing on decades of experience that firstly made us the global leader in generics, including life-saving antibiotics. In biosimilars, whilst remaining focused on sustainable and profitable growth through portfolio expansion and disciplined execution. Please turn to Slide five.
Turning to our quarter one performance, we delivered sales growth in line with our expectations, and importantly, the fundamentals of our 2026 trend roadmap are strong. We achieved 3% growth at constant currencies and when excluding the impact of adverse dynamics in the anti-infective B2B business, sales growth amounted to 5%. Our biosimilar portfolio continued to perform strongly with net biosimilar sales up 18%, including an exceptional biosimilar growth in International and North America, as well as further double-digit biosimilar growth in Europe. Total North America sales were very strong, with growth of 12%. From a business perspective, we continued to build momentum. We made strong progress on key launches, including Wyost and Jubbonti in the U.S. and Europe, as well as Afqlir in Europe.
Alongside the excellent progress we are making in building our biosimilar hub in Slovenia, we appointed Armin Metzger to focus our biosimilar development, manufacturing, and supply activities under one roof. This will drive faster decision-making, greater vertical integration, and improved launch readiness across the expanding biosimilar pipeline. We also advanced our strategic partnership with Samsung as we strengthened our biosimilar pipeline Finally, there were a number of positive regulatory decisions in the period, including for Eflornithine in the U.S. Based on this strong underlying start to the year and the visibility we have across the business, we are confirming our full year guidance today. We continue to expect mid to high single-digit net sales growth at constant currencies in 2026, alongside core EBITDA margin expansion of around 100 basis points. Now, let's look at the sales performance in more detail, starting with Slide six.
Quarter one represented an yet another quarter of accelerated growth, with biosimilars representing 31% of our total net sales. The underlying performance was strong, with the shift towards biosimilars continuing to increase the quality of our top line. Generic sales declined by 3% due to a number of factors. Firstly, we actively rationalized our portfolio, particularly in the international region, while we also continued to reduce the list of our partners that we use. Secondly, there was adverse phasing of sales, again, mainly in international. Thirdly, our European business was impacted by the effect of a mild season on the sales of antibiotics and over-the-counter cough and cold medicines. Finally, there were the adverse dynamics in our anti-infective B2B business. Remco will take you through these details in a moment. Please turn to Slide seven.
While biosimilars are the key growth engine for our business, generics remain a strong and essential foundation for sustainable growth, providing stability, scale, and reliable cash generation to support our long-term strategy. Our attractive generics pipeline covers around two-thirds of loss of exclusivity and is centered on oral solids and injectables. We continue to execute on consistent value creative launches and medicines such as rivaroxaban and estradiol illustrate how we can convert pipeline assets into tangible market opportunities. I want to reiterate that Europe remains dependent on a handful of global antibiotic suppliers. We continue to 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. Now let's turn to the biosimilar performance in the quarter on Slide eight. Firstly, we delivered strong performance from both Hyrimoz and Pyzchiva.
Hyrimoz continues to demonstrate strong growth, especially in Europe, with our global market share increasing. We continue to see strong expansion in biosimilar participation. We are well-positioned to benefit from this trend. Looking at Pyzchiva, we continue to see rapid and sustained market adoption in Europe. Sandoz's market share has grown quickly, making us the number one ustekinumab biosimilar across the continent. Importantly, ustekinumab biosimilar penetration has significantly outpaced historic adalimumab. Pyzchiva's sales are predominantly in Europe, with a contribution from North America remaining subdued to date due to the level of competition. Please turn to Slide nine. Let me now turn to Tyruko and Omnitrope. Starting with Tyruko, we are very pleased with the continued rate of adoption in Europe. We expect further sales growth.
Since launch, our market share has been stable, reflecting the strong clinical and economic value proposition of Tyruko as the only biosimilar approved in Europe for relapsing remitting multiple sclerosis. The recent launch in the U.S. has been encouraging, with a focus on naive rather than switch patients. We expect additional launches across more markets this year. Omnitrope continues to demonstrate exceptional stability and resilience in a highly competitive category, and we've maintained our leading global market share for this 20-year-old biosimilar. Overall, both medicines showcase the strength and diversity of our portfolio. Tyruko as the only alternative to the originator brand, and Omnitrope as a reliable long-standing leader in its class. Please turn to slide 10. Let me now highlight the strong progress that we're already making with Wyost, Jubbonti, and Afqlir.
Starting with Wyost and Jubbonti, we've established a robust commercial footprint in the U.S., building a 62% biosimilar share for Jubbonti and a 50% share for Wyost. We've secured broad U.S. provider access early on, alongside important wins with key players, enabling rapid uptake. In Europe, the launch has gone very well, rolling out into 27 countries on the first day, and I'm pleased with the early launch progress in Brazil and Australia. Turning to Afqlir, the European rollout is well underway, with launches completed in 19 markets, supporting improved patient access whilst contributing to a more sustainable healthcare system. Strategically, Afqlir plays a critical role in expanding our presence in the $15 billion global ophthalmology market for medicines that inhibit the VEGF. In the U.S., we're looking forward to the launch in quarter four.
Overall, being first to market with these medicines has given us a powerful head start, and the early uptake confirms that our strategy is working. We are well-positioned to continue to build momentum as access, adoption, and paid coverage expand across the regions. Please turn to slide 11. This slide highlights the depth and quality of Sandoz's industry-leading biosimilar pipeline, which is a cornerstone of our long-term growth strategy. In the near term, we have several assets in regulatory review. Looking further ahead, our clinical development portfolio includes major immunology and oncology assets such as Keytruda, Opdivo, and Ocrevus biosimilars to some of the most widely used biologics today. Finally, we have a significant number of additional assets in early development, and it's important to recognize how powerful the extended partnership with Samsung is.
Overall, this pipeline underscores our position as the global biosimilar leader with the scale, capabilities, and focus required to consistently bring high quality biosimilars to market and to capture a meaningful share of the approximately $320 billion opportunity over the next decade. Please now turn to slide 12. I'm very proud of the agreement that we recently signed with Samsung, reaffirming Sandoz as a leading partner of choice. The agreement will help us further strengthen the biosimilar pipeline ahead of our golden decade and accelerate patient access. Sandoz will commercialize the biosimilar to ENTYVIO, addressing a $6 billion opportunity. Samsung will lead development and manufacturing, while Sandoz will be responsible for regulatory, commercialization, and market access. The agreement also paves the way for collaboration on up to four other biosimilar assets.
Strategically, this partnership reinforces our commitment to building a significant share of the global biosimilar LO opportunity, particularly in high-value therapeutic areas. This partnership demonstrates how we leverage targeted collaborations to expand the pipeline efficiently, accelerate access for patients, and enhance long-term value creation while maintaining disciplined capital allocation and execution focus. With that, I hand over to Remco on slide 13.
Thank you, Richard, and hello, everyone. Please turn to slide 14. Turning to our top-line performance, the key drivers behind our Q1 net sales performance were strong biosimilar momentum and strong execution in North America. Net sales increased to $2.8 billion, representing 11% headline growth and 3% growth in constant currencies, impacted by the movements in the price of penicillin API, meaning an underlying net sales growth of 5%. Volume growth was a clear positive, contributing 7%, reflecting strong biosimilar demand. This was partly offset by a price impact of 4%. Foreign exchange provided an additional 8% tailwind. Overall, this performance reflects exceptional biosimilar execution and strong underlying fundamentals, which provides a good growth profile for the rest of the year.
Please turn to slide 15. Looking at the business mix, biosimilar sales increased to $0.9 billion, reflecting strong volume growth and continued uptake of newly launched medicines, resulting in biosimilar growth of 18%. Generic net sales were broadly stable overall, with an underlying decline of around 1% at constant currencies, excluding the impact of adverse dynamics of our anti-infective B2B sales. As you may remember, Asian suppliers engaged in price dumping for key penicillin APIs, including some that we sell to other businesses. This had a significant impact on the value of these sales, though we anticipate a materially smaller impact in the rest of the year. Looking at the regions, underlying Europe sales were up by 4% when excluding anti-infective B2B sales.
Biosimilar sales grow double digits. The generic performance reflected the mild seasons conditions and factors such as healthcare policy changes in France. International sales were mixed with an outstanding biosimilar performance, offset by generic sales that were impacted by the phasing of sales and the pruning of our portfolio. North America sales really stood out based on an exceptional biosimilar performance. Let's have a look at the balance sheet on slide 16. Last month, we further strengthened our balance sheet by issuing CHF 550 million in dual tranche bonds with six and 10-year maturities, while also extending our $2 billion revolving credit facility to March 2031. These actions significantly enhanced our liquidity profile, extended our debt maturity profile to 2036, and supported the refinancing of upcoming maturities.
Financing costs remain very attractive, with annual interest rate on gross debt expected to stay below 4%, and we continue to strengthen our investment-grade rating. I was very pleased to see that Standard & Poor's recently revised their outlook on Sandoz to positive. The strong capital structure gives us increased financial flexibility to support growth and execute our strategy. Please turn to slide 17. Let's move to guidance for the full year. We continue to expect net sales to grow by a mid to high single-digit percentage in constant currency, supported by the positive impact of our recent launches. The core EBITDA margin is targeted to increase by around 100 basis points, weighted towards the second half of the year. We continue to anticipate price erosion in the low to mid single-digit percentage range.
Outside of guidance, we now expect a 4 percentage point tailwind to net sales from currency movements based on recent spot rates and average rates in the quarter. Our prior assumption was a 2 percentage point tailwind. We still do not expect a material impact from currency movements on the core EBITDA margin this year. With that, I hand back to Richard. Please turn to slide 18.
Thank you so much, Remco. I'd like to now wrap up the presentation on slide 19 before we go to questions. To conclude, our Q1 performance was in line with our expectations, with underlying results driven by biosimilars momentum and strong execution in North America. This confirms that our strategic focus is translating into tangible results. The fundamentals of our 2026 roadmap remain strong. Our launches are going well, and we're accelerating access through our extended partnership with Samsung, which significantly enhances the breadth of our biosimilar pipeline and access for patients. Thank you for listening. Please turn to slide 20, and I'll 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 raise hand function in the Zoom app or via the telephone, press star nine. Thank you. A moment for the first question, please. Our first question comes from Sophia Graeff Buhl-Nielsen with JPMorgan. Please unmute your line.
Good morning. Thanks for taking my question. One on the guidance. Just could you outline further what gives you confidence in an acceleration in the top line growth through the remainder of the year despite the tougher base and also the annualization of the launch for denosumab in the U.S.? Just on denosumab in the U.S., you've highlighted the high market share you have with Washington County. How do you see the growth of these assets developing in the U.S. in the coming quarters given additional competition in the market?
Thank you, Sophia. Good to hear from you. Perhaps if I do the second question first, and then I'll pass to Remco. You can turn and talk about the acceleration that we expect in the second half of the year. The market share is that's the 66% of the available biosimilar. There's still a significant proportion to take of the originator asset. I think we're well-positioned. I think we had a nice runway. We took a leadership position by being first to market. We had the PICs code early on, and we've leveraged that relationship. Anticipate further gains in market share as we go out through the rest of this year. I'm really delighted with the performance that the U.S. team have delivered.
Remco, do you want to talk about?
Yeah
guidance?
Hey, Sophia. Good morning to you as well. Remco here.
Yeah, we have seen in Q1, we had a formidable biosimilar growth of 18%, and we expect this biosimilar growth to continue also in Q2, Q3, and Q4 in a very positive way based on the launches we have and still other things we have in the pipeline. As you have seen that the Q1 sales in generics were impacted by some incidentals. We have been pruning the portfolio a bit in international. We had the impact of the B2B price dumping by the Chinese. As you know, that started in the summer last year. By the second half of this year, this should have faded through the system.
The impact we have in Q1 on the generics, we expect as of Q2 that will mostly disappear. Therefore, for the full year, we stick to our outlook for mid to high single guidance. This was always what we expected. I think we gave the guidance in this regard. We're very happy with the Q1 results it stands, and we stand fully behind our full-year results.
Thanks very much.
Our next question comes from Victor Floc'h with BNP Paribas. Please unmute your line.
Hi. Thanks so much for taking my question. Maybe one only on the different, like, generics headwinds that you faced over the quarter. Maybe any chance you can discuss the portfolio rationalization you've mentioned in international? What's expecting to into this rationalization, and what should we expect for the midterm? Can you so maybe quantify the phasing in international, and how should we expect the growth in international, like, over the coming quarters? Finally, any comments would be helpful on the market dynamic in Germany and the policy changes you've mentioned in France. Thanks so much.
Thank you, Victor. I think the second question about Germany. Was that correct? I'll take it. Yeah. Let's talk generally. We have a large portfolio. I think something like 29,000 SKUs across our business. We are always constantly looking at pruning or moving out non-profitable or margin dilutive assets, and particularly in international as we've streamlined the business. I think we've exited a few smaller markets. We've cleaned it up, and it's ongoing. Really the impact was Q1 a little bit into Q2. It won't have a broader impact beyond that. I don't really see that continuing much more beyond this quarter. I think Remco covered the sort of the headwinds and the tailwinds.
I think really a lot of the headwinds wash out in Q1, particularly the Chinese dumping and the B2B, the cold season in Europe. Then really we see the generics business stabilizing and then strong momentum building and continuing in the biologics. In terms of Germany, I think the question here relates to the potential changes in terms of tendering into the sick funds. We've had very good access to the German government. The team have done a phenomenal job. That legislation won't come until really until 2028, I think the current guidance. Actually in the medium long term, I see this as a positive. What that means is that access is gonna be driven far more aggressively.
As we expand our pipeline over the next few years, I see that as a significant growth driver, additional growth driver to the German market. Very pleased, but I think we're still working, but delighted with the relationship that we've been able to build with the local government in terms of that policy.
Our next question comes from Charlie Haywood with BofA. Please unmute your line.
Hi. Charlie Haywood, Bank of America. Thanks for taking the question. Is it just one on phasing for the year? I think obviously 2Q, you're still getting some slight B2B headwinds, and you just alluded to their slight rationalization headwinds as well. Is it sort of fair to think 2Q is still slightly down, and then you're thinking of a better second half, or as in slightly softer and a better second half? On that as well, just the phasing of FX in the year, I think +4% surprised many people. How should we think of the phasing of that through 2Q, 3Q, 4Q? Any color there would be appreciated. Thank you.
Thank you, Charlie. I'm gonna hand that one to Remco.
Charlie, good morning. Thank you for that question. Correct. As Richard gave a little bit more details on the GX. As we currently see, we see Q2 at a better top line than we had in Q1. Correct. That it's not something which fully weighs for H2. For H2, we would still expect a higher full H2 versus a full H1. You should expect as of Q2 an higher top line growth number. The FX, you saw an impact of 8% in Q1, and we guided for 4% for the full year.
There should be still also in terms of the phasing, relatively more material impact in Q2 and then becoming less in H2 of this year because also then the whole FX impact is phasing out. Of course, we're happy with that because it impacts as well the absolute amount of EBITDA and EPS and net income. You've also seen that in terms of the EBITDA margin, we're able to manage the FX. The margin has no impact on the margin. Perhaps also to comment because some of you might then also ask the phasing of the EBITDA over the year. We expect still a step up in the EBITDA margin in the guidance of 100 basis points.
Of course, when the sales is a little bit more weighted through the second half of the year and also the margin improvement comes from the leverage on our cost base, it should be a little bit higher benefit in H2, but we still expect a very good benefit in H1 to come in. Everything here fully on track.
Our next question comes from Shyam Kotadia with Goldman Sachs. Please unmute your line.
Hi there. Thank you for taking my questions. The first one I have is on generic semaglutide. It looks like one of your competitors got the Health Canada approval yesterday for generic Ozempic. Just wanted to see if there's any update from your end in terms of timing of approval and launch, or is the expectation here still that it's the second half 2026 launch? Yeah, any updates you have as well on the potential Brazil and Mexico launches would be appreciated. Any color you could provide on the device or the approach, because it looks like, I guess, Dr. Reddy's going with the chemical synthesis approach. That's the first question. The second one is just on the biosimilar launches.
I think the key ones you flagged this year is EYLEA in the U.S. in 4Q, and then Lucentis in Europe. Are there any others that we should be aware of over that 2026, 2027 period? Because I can see you've got some insulins and some legacy oncology products like Herceptin and Avastin in your pipeline. When could we expect them? Thank you.
Okay. First of all, good morning, Shyam. Thank you, folks, so much for getting the 1st GLP question. That was a little bit later than I was expecting. Thank you. Look, I'm not gonna say anything particularly new to what I've already said before. We're extremely confident of launching in Canada and Brazil in probably the second half and the latter part of this year. That remains unchanged. We will see. I think it's an exciting opportunity. Mexico, I think, is actually a little bit later because the patent situation in Mexico is different. It's very much, I guess, Brazil and Canada this year and then a number of markets as you go into next year, Turkey and a number of other markets around the world. Fascinating opportunity.
Again, as we get more color, clearly we'll give you more information as that evolves. In terms of launches, I think the Afqlir launch I'm particularly excited about. I think it's actually a nice opportunity in the U.S. We've obviously got approval, so we're well positioned to launching that in Q4. That'll actually create some nice momentum as we go into 2027. As you rightly say, there's a number of more local assets, so things like insulins, et cetera, that we'll launch in specific geographies. We tend not to disclose in local assets because it gets so complicated. We normally only talk about the bigger assets. That said, I think, you know, I know a theme we get asked a lot is, you know, how you see 2027, 2028 shaping up.
I think with the underlying momentum in the business, I think we could expect that growth momentum to continue into 2027 and 2028. Again, we'll discuss that perhaps a little bit closer to the time.
Our next question comes from Simon Baker with Rothschild & Co Redburn. Please unmute your line.
Thank you. Thank you for taking my questions. Two if I may please. Just going back to one of the earlier questions, in terms of the impact of rationalization, if you could give us any sort of quantification of that, the magnitude of that would be very handy. Secondly, a question on Hyrimoz share, but it's broader than that. It's more of a sort of conceptual question. If we look at the global share for Hyrimoz, it's been pretty stable over the last few quarters at sort of 20% ±1. I'm assuming if one looks regionally or at the country level, there's a lot more movement there.
I'm just wondering if you could either for Hyrimoz or more conceptually, generally for biosimilars, how is your market share changing at beneath the surface there? Do we see much movement at a lower level that averages out so you end up with a reasonably stable global share? Any sort of thoughts on how we should think about that specifically to Hyrimoz, but going forward, would be really handy. Thanks so much.
Thank you, Simon. Perhaps if I take the second question first, I'll put the first question to Remco. It's a good question, and I think I touched on it in my presentation. If you look at ustekinumab, what's interesting with usta, the penetration accelerated and the market expanded faster as we launched that. We saw, particularly in Europe, this really the adoption happening. I think, A, what it's telling you is the payers and physicians are much more ready to accept biosimilars opening up the market and driving momentum. I think part of the problem with Hyrimoz is that the IQVIA data in the U.S. is pretty useless because the PBMs don't actually want to disclose the data or give the data to IQVIA. It's actually very difficult to get a stable view.
You know, globally, 20% share of the biosimilar market. I think that's a strong foundation. We're seeing faster adoption of biologics when we bring. Certainly in Europe, we see a very strong expansion of that market post-launch for quite a period afterwards. The U.S. does have a slightly different dynamic. If you look at adalimumab, actually the number of patients on adalimumab has gone down, as the originator effectively has used rebating to force patients onto newer assets. That will be illegal in Europe, but that somehow is acceptable in a U.S. environment, and that's just the nature of the business. Again, pleased with the position that we've got, and strong momentum underlying.
Let me take the other question. Good morning, Simon. Yeah, I don't think it's appropriate to go in too much detail. I'll still try to help you as much as I can. If you would take international generics growth, it normally should be in the low single digits. Correct? A couple of factors influencing this, which is one, the B2B, correct, which we give some indications about. Of course, we have the pruning and the phasing and a bit of the soft cough and cold. That combination explains roughly the delta between the number which has been published and the normal trend which we would have, right? We should be without that under normal trend.
Europe had an impact a little bit less on the B2B. Still the Covid gold season also impacted. There is no phasing of pruning in the European portfolio applicable. In the U.S., this pruning and the one-offs is not applicable. With that, without giving you any specifics, still helps you to give some idea of where it's coming from, and you can do your own homework.
Right. Thanks so much.
Our next question comes from James Gordon with Barclays. Please unmute your line.
Morning, everyone. James Gordon from Barclays. Thanks a lot for taking the questions. Two questions, please. First one was 2027 and 2028 outlook. I heard some encouraging comments about top line momentum continuing into 2027. Do you think there is a scenario where you might still be able to do sort of on the medium-term trends or mid-single-digit top line in 2027 and 2028 before the golden decade of launches really kicks off in 2029? You still it would be sort of more likely that there is some deceleration? Given that, what would be the appetite to do some in-licensing this year to boost things a bit inorganically in 2027 and 2028 before things kick off? That would be the first question, please. The second one, got to ask something else on generic sema.
Yeah, the Dr. Reddy's got approved, but I think it was not all doses. Is that like that's some sort of regulatory issue? Might that impact you as well that it would not be all doses, or do you think you would hopefully get all doses approved? More generally on generic Sema , we have seen some very low cost launches in India. I think there is eight generics and the vial form is about $14, which is a very low price. I know India is not one of the markets you are going for, but is that a negative that suggests that very low cost generics are going to come in the West and this would not be an attractive market for Sandoz because the prices can obviously plummet?
Is it a bit positive because you're actually going to source this very low cost material and that means you can really do well in the West? How to interpret these really low prices?
Thank you so much, James. I mean, look, let's talk about 2027 and 2028. Look, I mean, we signal 2027 and 2028 more about this is a period where there's actually just very relatively few LOEs. Doesn't necessarily imply that Sandoz won't continue to grow in 2027 and 2028. First of all, I think we need to separate those two things. There's a lot of small molecule launches. Obviously, we've not put semaglutide in, into our guidance either at this point. Clearly, we're going to launch that. There's a lot of good tailwinds going from 2027 into 2028. Launching aflibercept in the U.S., that will obviously contribute nicely in 2027. I think there's a number of areas.
We've not given guidance. I think we originally said, "Look, when we get to 2020, 2028, that would be in aggregate mid to mid-high single digits." I think that we always said it won't necessarily be a straight line, but I think the direction of travel is clear. Certainly, we would expect 2027 and 2028 to continue growing. I think we'll give guidance when it's appropriate to do so. Semaglutide, look, it's early days. I stand by what I said earlier. I think we're confident that we would bring presentations to Canada and to Brazil this year. I think it's an exciting opportunity. That remains unchanged. Look, the Indian generic market, if you looked at any product in the Indian generic market, there's a wide range of pricing.
I would never draw an analog from Indian pricing of generics into any other market in the world. It's a unique market. It has unique dynamics. You know, I'm confident this is gonna be a really interesting product. I still stand by my comments. I think certainly in the first parts of the first few years, I think this is gonna be more about availability of supply than oversupply and commoditization. I think demand for this product will be substantial, and particularly in markets like Brazil, where these are really predominantly much more out-of-pocket, more, I guess, consumer-like markets. I think there's a phenomenal opportunity. Stand by that. I think we will discuss it more, no doubt, during the year. Let's see how that evolves.
Our next question comes from Nicolas Pauillac with Kepler Cheuvreux. Please unmute your line.
Hi, guys. Thanks for taking my question. Maybe two, let's say macro level question from me. The first one will be that since the beginning of the Q1 season, we saw a lot of comment from the pharma CEOs about the impact of MFN and trying to say that Europe will have to step up in term of pricing if they want to continue to see new innovative drugs. You guys that are sitting on the other hand, how do you think about the MFN impact for Europe and especially on biosimilars? Do you think it's a good opportunity to, I don't know, secure more market share and get a bit of a win on pricing there too? That would be the first one.
The second one is also macro level, but just it's been, let's say, almost two years since we had the first of phase III waivers. How does that translate now when it comes to discussion on licensing deals? For instance, the new deal you did with Samsung Biologics. Do you see some change on the financials or is it still the same as what you would have signed, let's say, two years ago?
Okay. No, first of all, thank you so much for the question. MFN, honestly, I think, you know, from Sandoz point of view, zero impact on MFN. I think what's interesting, I mean, we're getting very good access to. I met more ministers of health and prime ministers and chancellors over the last few months than I have in the rest of my life. I'm not sure that's a very good or bad thing, governments wanna talk to us. I think they recognize that we're very much part of the solution rather than part of the problem. I mean, fundamentally, Europe is getting older, sicker, and poorer. We're very much part of that solution.
As an industry, we supply something like 80% of the drugs at about 25%-30% of the cost. That also then positions us extremely well for this golden decade. You know, as Sandoz really leverages this incredible opportunity with something like $350 billion of biologics coming off patent and about $300 billion of small molecules. That's more than this industry's ever seen in the history of this industry. I think Sandoz is in such a strong position. That partly answers your second question is, you know, now is how we accelerate our pipeline. I think when we started this journey seven years ago, I think we had six products in the pipeline. Clearly, we've launched quite a few of those now, but now we have, what, near 32, growing.
You know, that's really, really exciting. Clearly, in relation to your question, the cost of developing these drugs is going down. It's still significant. It's still probably $100 million a throw. We're encouraged with that direction. I think as we then leverage that scale that we've got, improving efficiency, then effectively we can bring more assets, as we invest in our pipeline and partnering. I'm very pleased. I think it creates a great opportunity for patients and a fantastic opportunity for Sandoz.
Our next question comes from Urban Fritsche with ZKB. Please unmute your line.
Yes. Good morning, everybody. This is Urban Fritsche from ZKB. A couple of more big picture questions as well. In recent weeks, we heard about the Amneal-Kashiv and the Sun Pharma Organon business combinations, driven clearly also by biosimilar opportunities. I would be wondering about your thoughts on this announcement, and do you see this more as a one-off event, or is this the beginning of a consolidation wave, and what does it mean for Sandoz? Is question one. Then question two, big pharma in general is very efficient for good reasons in developing extension strategies for their big brands. Have you seen any major shifts of timelines for your potential launches in your biosimilar pipeline portfolio?
No. Okay. Look, first, thank you so much for your questions, Urban. If anything, I think the Sun Organon deal validates a lot of the things that we've been saying. You need scale. You know, Sandoz has a leadership position in the majority of the markets in which we operate. We're the largest player in Europe, you know, fast, it's accelerating biosimilar player in the U.S., aspiring to be the number one player in the U.S. I think it's about scale, capability and execution. And I think it reaffirms that. I think it's an interesting move. It's a little bit going back to sort of 10, 20 years ago where you saw some consolidation.
I think the benefit that Sandoz has is already at scale a little bit, but I think it reaffirms the position that we've taken and the strategy that we're deploying. In terms of big pharma, look, this story's as old as the hills. You know, as long as I've been in this industry, which is, which is quite a while, they've always been looking at either formulation changes, patent dances, whatever. Nothing's new. I think we've not seen any material changing to our pipeline. Again, you know, we're fortunate. This isn't about one or two products. You know, today we have 32 assets. We're covering about 60% of that $350 billion. Clearly, there's opportunities to improve that over the next few years, which completely de-risks any delays.
This is never normally about one product and one market. As we see from our launches, you know, we've just launched denosumab in Europe. We're in 27 markets. filgrastim, again, a significant number of markets at launch, and then continuing afterwards. I think we're nicely positioned, many markets, many launches.
Our next question comes from Christopher Richardson with Jefferies. Please unmute your line.
Hi. Thanks very much for the question. Just a quick one on historical market shares for the disclosed biosimilars. They've all changed. I was just wondering if you could clarify how that recognition or reporting standards changed and if you saw any material change in trends. Just if you could quickly clarify the pricing pressure seen in Germany for Pyzchiva and whether we should expect this to spread to other regions or other biosimilars. Thanks very much.
Okay. I mean, I don't think anything specific in Germany in Pyzchiva. I think it's the point I made earlier was that we expect the sick funds to change some of their purchasing in 2028. I don't see a necessarily an unusual dynamic. Again, Germany, we're in a very nice position because what's unusual about Germany, particularly for products like Pyzchiva, is that pharmacy chains don't exist in Germany. They're all mom and pop pharmacies, and we have a very strong relationship. Even when we win a formulary, we get strong leakage over into the pharmacy network. I think that positions us extremely well. Again, when you look at the performance of Pyzchiva, we've taken a leadership position pretty much now across the whole of Europe, and we're very pleased with the performance.
Sorry, your second question was market share data. I mean, we're happy to come back to you. I mean, I think the challenge, as I alluded to earlier on, is the U.S., and clearly last year, the PBMs stopped reporting the sale of a number of biologic assets to IQVIA, which sort of means you have to sort of build an analog. That's really the only significant change that I've seen over the last couple of years. I know it's made certainly looking at the U.S. market a little bit more tricky.
Our next question comes from Thibault Boutherin with Morgan Stanley. Please unmute your line.
Thank you very much. Just a couple of question on the Samsung agreement. Can you just give us any color that you can on the economic sharing here? Is the Stelara deal a good blueprint for the five biosimilars that you signed? Well, with Stelara you're not, in the U.S. you're not booking revenues, you're booking royalties. Any details helping us to understand, you know, the margin contribution of these biosimilars would be helpful. Just second question on Tyruko market share. In Europe have been stable for a number of quarters. If you could just help us understand the dynamics here and how you expect this to evolve going forward. Thank you.
Okay. Thank you Thibault. Sandoz, this is a very different deal structure to the ustekinumab deal. That was a straight in-licensing deal. This is much more a partnership and development. Which is why I did make the point that we were taking responsibility for the regulatory work, the market access work, and all the commercialization. Much more, I guess, an equal partnership rather than a straight in-licensing. Clearly more attractive and accretive to our business. I think it's a very different model. You can't really draw the same parallels. I think the nature of those two deals was very different. Tyruko, we've always said, you know, in the U.S. our targeting are naive patients, and that's going exactly to plan.
In Europe we're pleased with the switches that we've taken and continue to win share. Again, this was always going to be a build rather than a bang. These patients, you know, really need a lot of support. Physicians need support. It's a great product. Clearly we see no likelihood of a competitor anytime soon. We will continue to deliver and work with customers to grow the product.
Our next question comes from Natalia Webster with RBC. Please unmute your line.
Hey there. Thanks for taking my questions. A few follow-ups for me please. Firstly, on denosumab, you reported the 62% and 50% biosimilar shares. Are you able to comment a bit more on how you expect this to evolve with the additional biosimilar entrants and how you're thinking about volume gains versus pricing erosion through the year? Secondly, on aflibercept, are you able to talk more on how you're looking at potential contribution from the upcoming U.S. launch in 2027, factoring in the expanded label but also Amgen's head start there? Finally, on margin, you mentioned you're still expecting the H2 weighting given the operating leverage. Are you still expecting that 130 basis points of improvement coming from mix for the full year as you indicated previously?
Beyond the operating leverage and mix, are there any other phasing impacts to call out here? Thank you.
Thank you, Natalia. Perhaps if I let Remco go first to take the third question and I'll do the first two then.
Natalia, good morning. No, in terms of the structure of the improvement of the margin, nothing has changed. It comes from two elements. From margin improvement, being bio being a larger part of the portfolio and that continues as you see this year. The second is the leverage over our particularly our marketing, sales and G&A expenses. That continues. That is the case in H1 we expect to be the case. We expect that the case to be also in H2. What I just made a comment is that relatively the sales growth is a bit higher in H2 than H1. You have a little bit more impact of the leverage and therefore the margin is a little bit more weighted for H2. That's the only difference. For the rest, everything is the same. Back to you, Richard.
Thank you. On denosumab, I think partly you said, look, there's still an awful lot market to go at. Even though clearly competitors are coming into the market. We're also, in a sense I'm less concerned about volume share, it's about value share. Here is keeping control of ASP, making sure that we don't lose control of the discounting and the rebating. We're very thoughtful about the channels and the partners that we work with. We're not trying to solve everybody's problem. Really I think there's still momentum that we can create in that business and do that in a way that is sustainable and value creating, rather than necessarily chasing this to the bottom and winning volume share.
Really this to me is a value game, not a volume game, over the next few years. Afqlir, I think it's too soon to call. You're absolutely right. I think it's a super great opportunity. We're delighted with the performance that we've seen in Europe. Really, you know, that the team have really knocked it out of the park, I must say. I think as we go and look at taking that learning, applying it to the U.S., I think that plus with Cimerli now coming back into the U.S. market, it puts us in a very nice position to bring that market into really late 2026, really I think the impact will flow through into 2027.
Our next question comes from Beatrice Fairbairn with Berenberg. Please unmute your line.
Hi. Thank you for taking my questions. I just had a quick one on whether or not you had or are expecting any inflationary impact on input costs such as, you know, energy or freight. If so, how do you plan to mitigate this? Secondly, you've discussed the active portfolio rationalization in the international generics business. Can I just check whether or not this portfolio rationalization process is expected to be extended in kind of any significant way or kind of impact to other regions as well? Thank you.
Yeah, look, I mean, on the rationalization, I mean, look, as I said earlier, we have something like 29,000 SKUs and we launch I don't know how many thousand SKUs a year. In a sense, it's a discipline and an ongoing thing that happens in the business. Clearly, if you have pro-products and particular lines that are underwater or dilutive, we either challenge in terms of looking at raising pricing or end of day pruning. That's an ongoing process. I think in international, we want to be much more targeted and specific about certain markets and certain products. As you see then, really the business focus in international is accelerating then the biologics. Again, I was particularly proud with what the team had delivered in the first quarter.
You saw strong momentum coming in the biologics and then really less focus on very value destroying small molecules in that. In terms of input costs, I think we're nicely positioned. I mean clearly we're sitting on a good inventory. We've got good API levels. In a sense that cost there, and we've hedged our energy. We have a good, nice long-term hedge in our manufacturing site. In the short to midterm, I don't see any significant inflationary inputs. Beyond that, look, clearly air fuel's gone up, shipping costs are going up, but that's true to everybody. That's not clearly not a Sandoz specific position. I think we're well-positioned. I know there's some debate, particularly in the U.K. media about possible supply disruptions.
At the moment, we're tracking it very carefully. Certainly we're comfortable at the moment in our ability to maintain supply to patients, particularly given our strength in Europe. We'll see. I guess your guess is as good as mine in terms of how long this thing's going to continue. We will see.
Our last question comes from Florent Cespedes with ODDO BHF. Please unmute your line.
Can you hear me?
Yes, we can.
Good. Thank you very much. Florent Cespedes speaking from ODDO BHF. Just to come back, a follow-up question on the pruning strategy. Do we have to understand that you did something, it's business as usual. It's something that you may extend and maybe do more rationalization on the international or on other territories. And if you have some proceeds and capital gains from this strategy, do you confirm that it will be excluded from the operating profit guidance? That's my first question. Second question on the generics business. Just to come back on the second half of the year, do you confirm that you should have more new launches in the second half of the year on the generics business?
Last question, I know it's pretty small, business, but in the U.S., generic business, any comments on the performance here, and if you continue to be focused on the more profitable, products rather than the products which are, let's say, facing a tough competitive landscape? Thank you.
Thank you so much, Florent Cespedes. Perhaps if I just talk about the generics and the U.S. Look, I think the generics business in the U.S. did extremely well. We're very pleased with the performance the U.S. team delivered. It's still an attractive market. I think there we've always said, look, it's much more about specific opportunities. Obviously we gave Paclitaxel was a good example, I think last year, and then there's been a number of others that we've launched, ferumoxytol, et cetera, et cetera. There's been some very attractive launches that have performed extremely well in the U.S., and we will continue to look to do that and file. Our ambition in the U.S., no desire for us to be the number one generic player in the U.S.
Clearly, our main growth driver is biologics and are executing extremely well in the U.S., I think we're doing that. From a broader GX timetable, I mean, I think our guidance here really is, look, we expect the headwinds of generics will wash out particularly Q1 into Q2. As we get into Q3, Q4, that will stabilize and then continue to potentially grow. It is always launches. I mean, we've got something like 400 generic projects ongoing at any one time. There's so many launches, it's very difficult. It's not normally one big specific generic launch. You know, I think really we've tried to explain why Q1 into Q2, why that washes out as we go into the second half of this year.
With the strong underlying growth we're seeing in biologics continuing to deliver and support the overall business. I think that's really how I view it. Remco?
Yeah. Perhaps add your question on the pruning, huh. It's a bit of repeat what Richard already said. The biosimilars is really we want to double-digit growth. We have done that. We will continue that. That will also happen in international. Generics is a quite broad portfolio, we just have any other company and responsibility to look at our portfolio. If there are certain parts of the portfolio which will make sense to discontinue, we will discontinue that. You saw relatively a bit more impact in Q1, but it's something we have done also in the last years. There's a relative more impact in Q1 and the rest of the year we will expect or H2 expect less of this impact to happen. That's all.
There's no one-off related income or cost related to this pruning. This is just an adjustment of the portfolio. That's all.
Good. Thank you very much. Very clear.
Thank you.
I think that was the last question. Just wanted to thank everybody for your time this morning. I think, you know, pleased with the first quarter exactly as we'd expected it to come. Delighted with the momentum that we're seeing in biologics, particularly strong call-out performance in the U.S. and international. Excited about the momentum we're building throughout the rest of this year. Again, confirming our guidance, look forward to talking to you again shortly.