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Operator: 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.
Craig Marks: Thank you, and welcome to the Sandoz H1 2025 Results Call. Earlier today, we published a results announcement and an accompanying presentation on our website, which we'll follow today. You can find these documents at sandoz.com/investors. Joining me today are Richard Saynor, Chief Executive Officer; and Remco Steenbergen, Chief Financial Officer. Please turn to Slide 2. Our results announcement presentation and discussion include forward-looking statements. Please see our disclaimer here. Please turn to Slide 3. Richard will begin today's presentation with a summary of the highlights in the first half of the year, followed by an update on the business. Remco will cover the financial performance as well as our full year guidance. Following a wrap-up of the presentation, we'll be happy to take your questions. With that, I'll now hand over to Richard. Please turn to Slide 4.
Richard Saynor: Thank you, Craig, and hello, everybody. It's a pleasure to welcome you all to today's call, and I'm looking forward to taking you through the strong progress we're making as well as the significant opportunities that lie ahead for Sandoz. Please turn to Slide 5. I'm pleased to provide an update on our strong performance in the first half and the continued execution of our long-term strategy. We delivered 4% sales growth, which on an underlying basis, amounted to 6%. The performance included accelerated sales growth in the second quarter, a period when 30% of our net sales came from biosimilars. Our core EBITDA margin in H1 expanded by 2.5 percentage points, reaching 20%, reflecting an improving sales mix and operating leverage. On the pipeline, we executed all launches successfully, including Wyost and Jubbonti and Pyzchiva in the U.S. and the Pyzchiva auto launch -- auto-injector in Europe. We have additional exciting launches planned for the second half of the year, further strengthening our portfolio and our long-term growth potential. Also we announced the expansion of our manufacturing capabilities in Slovenia, reinforcing our commitment to reliable, high-quality supply for our global markets. You've also seen the recent news of our planned acquisition of Just-Evotec Biologics in-house development and manufacturing capabilities in Toulouse, France. With these bold steps, we're building a leading global end-to-end biosimilars platform from development through to manufacturing and commercialization to fully capture the significant growth opportunities in the biosimilars space. Looking ahead, we remain confident in our midterm outlook. I'm pleased to confirm our full year guidance, namely, mid-single-digit net sales growth at constant currencies and a core EBITDA margin of around 21%. Now let's move to more details of the business performance, starting with Slide 6. Looking firstly at our biosimilar launches, we rolled out Pyzchiva in the U.S. this year. This was an important moment for millions of patients living with chronic autoimmune diseases and reinforces our commitment to broad access to treatment options for patients while helping to build a more sustainable health care system in the U.S. Furthermore, I'm pleased that we launched the Pyzchiva auto-injector in Europe. This was the first ustekinumab biosimilar in Europe commercially available in an auto-injector. The device supports a more comfortable self-administration experience with an accurate automatic dosing and less frequent injection pain, offering the potential for improved adherence to patient treatment plans. I'm also very excited about the launches of Wyost and Jubbonti in the U.S. in June. These were the first and only interchangeable denosumab biosimilars in the U.S. providing new affordable treatment options for over 10 million patients suffering from conditions such as osteoporosis and cancer-related skeletal events. In the second half, we look forward to contributions from several other exciting biosimilar launches, such as denosumab and aflibercept in Europe. And we also have continued ambition to launch natalizumab in the U.S. by the end of the year. Now let's deep dive into the performance of Pyzchiva on Slide 7. This important new medicine continued to make strong progress in the first half following the European launch in 2024. It has now been launched in 24 markets, and we've achieved a leading position in Europe. The auto-injector launch marked another important milestone as we strengthen our leadership in the immunology biosimilar space and reaffirm our commitment to pioneering access across Europe's evolving health care landscape. We're also pleased with the recent Pyzchiva launch in the U.S., which included private label. We look forward to updating you on the progress of this in the future as we move beyond the immediate launch phase. Now please turn to Slide 8. Turning to Hyrimoz, our global market share has been cemented by the ongoing progress of biosimilar penetration, which has now reached over 60%. It is important to note these dates exclude private label, which means actual usage may be even higher. We're seeing very strong momentum in Europe, accompanied by growth in international markets. And in the U.S., Sandoz is leading the biosimilar space, driven by both private label Hyrimoz and our own label, adalimumab. We also benefit from having the broadest payer coverage in the U.S., a key advantage in such a competitive market. Together, these trends position Hyrimoz as a cornerstone of our biosimilar portfolio. Now please turn to Slide 9. Let me now turn to Tyruko, our biosimilar natalizumab, which continues to demonstrate encouraging momentum. Since we started rolling out Tyruko across Europe, this important medication has been growing consistently, achieving a 20% market share. Both tender authorities and health care professionals alike appreciate a more affordable option in the multiple sclerosis space. Looking ahead, we have additional launches planned across Europe in the second half of the year, which we expect will further strengthen our position. As I said earlier, we continue to have the ambition of launching Tyruko in the U.S. before the end of this year. Now please turn to Slide 10. Finally, after almost 20 years since it was launched, we again delivered double-digit growth from Omnitrope, which continues to speak to the sustainability of biosimilars. The performance underlined our continued market leadership, driven by a particularly strong ongoing performance in the international region. Equally important, we have benefited from being a reliable supply partner ensuring where we can consistently meet strong and growing demand. With a 35% global market share, Omnitrope continues to lead in the treatment of growth hormone-related disorders and it remains a core pillar of our biosimilar portfolio. Please turn to Slide 11. Moving now to our pipeline. We announced during the period a collaboration license agreement with Henlius, strengthening our position in oncology and underlining our purpose of pioneering access to patients. As the global leader in generic and biosimilar medicines, we are committed to innovation and dedicating to broadening access to more affordable biologics for patients globally by finding the right balance between leveraging internal capabilities and collaborations and partnerships. This agreement, providing access to ipilimumab, strengthens our leadership position in oncology even further. Now please turn to Slide 12. Today, we have an industry-leading biosimilar pipeline of 27 assets, covering around $200 billion of originator sales. Through a combination of in-house development and partnerships, we've been able to significantly increase the size of our pipeline over recent years. We plan to further increase it. We're also encouraged by the recent movements towards regulatory streamlining such as the recent news on our development of pembrolizumab, ocrelizumab and nivolumab biosimilars. These dynamics have the potential to accelerate approval times and reduce complexity, ultimately benefiting patients and health care systems alike. At the same time, we continue to identify and pursue additional opportunities that will strengthen and expand our pipeline. Please turn to Slide 13. This pipeline of 27 biosimilars is industry-leading, both in the number of assets and the portfolio coverage of the addressable market value. It includes 5 near-term launches and assets in clinical development, 5 assets in regulatory review, 8 in technical development and we have 9 additional assets in early development targeting around $56 billion of originator sales. This is an incredibly exciting pipeline, and we won't stand still. We aim to increase the number of assets even more, supported by the opportunities presented by regulatory streamlining and our growing in-house development capabilities. Now let's turn to Slide 14. Biosimilars is the fastest-growing segment of our pipeline as the needs of patients and health care systems for these critical medicines continues to grow rapidly. As the global leader in the field, we're investing to meet rapidly growing patient demand. We're proud to significantly expand our biosimilar manufacturing capacity in Europe as Slovenia's largest direct foreign investor. This is another major step that will position Sandoz uniquely to capitalize on the unprecedented biosimilars market opportunity over the next decade. We've talked before about our state-of-art development center in Ljubljana and in Lendava, our high-tech drug substance production center. Last month, we also announced the start of the construction of a new state-of-the-art biosimilars production center for sterile product manufacturing in Brnik. I'm delighted by our progress in Slovenia as we build internal capacity and drive biosimilar development. Of course, this was all complemented by our announcement from last week. Please turn to Slide 15. The news of the proposed acquisition of Just-Evotec Biologics in-house development and the manufacturing capabilities in Toulouse, France marks a significant leap in our biosimilar future. The acquisition totaling around $300 million would seamlessly align with our strategic objective of capitalizing on the biosimilar market opportunity. Just-Evotec Biologics has been a key strategic partner for Sandoz since 2023. The proposed acquisition would complement previously announced investments in Sandoz biosimilar manufacturing and development sites and will be fully in line with our strategy to reinforce in-house biosimilar capabilities whilst at the same time create additional strategic flexibility. Following a successful completion, the site will be used to develop and manufacture our biosimilars. Just-Evotec's fully automated and high-throughput technology platform will help us move faster, scale smarter and maintain high quality while keeping costs under control. And I look forward to updating you on the progress of this proposed acquisition. Now let's turn to Slide 16. Turning to our generics business, it continues to be a cornerstone of our company with over 180 launches across markets in the first half of this year from around about 90 different medicines. For example, our generic ferric carboxymaltose is the first-to-market launch in Europe and we target over $500 million of originator sales. Generics at around 70% of our sales ensures continuous scale in the market with limited capital deployment and generation of significant cash flows. In the first half, our generics performance benefited from volume growth that partly reflected recent launches such as paclitaxel. Looking ahead, our second half program is ambitious as we expect more than 3 individual market launches over the full year. Over the longer term, we continue to have an ambitious generics pipeline with more than 400 assets targeting around $220 billion of originator sales over the next decade. And with that, I'll hand over to Remco. Please move to Slide 17.
Remco J. Steenbergen: Thank you, Richard, and hello, everyone. Please move to Slide 18. I'm very pleased to share our strong financial performance in the first half, which reflects momentum and disciplined execution across our business. Firstly, we delivered underlying sales growth of 6% with accelerated sales growth in the second quarter. Next, our relentless focus on operational efficiency is paying off, and the leverage down the P&L drove core EBITDA margin expansion of 2.5 percentage points bringing the H1 margin to 20.0%. We believe a meaningful improvement. Thirdly, core diluted earnings per share reached $1.46 representing growth of 33% at constant currency. Finally, we delivered a strong improvement in cash generation with management cash flow more than doubling to over $500 million, a significant milestone that further enhances our financial flexibility. Overall, these results position us very well for the second half of the year. Please turn to Slide 19. We produced a strong performance in the first half, and we are gaining momentum with further launches to come in H2. While generics provides a strong foundation for our business, the overall performance reflected the increasing contribution from biosimilars and strong execution across our organization. As a result, biosimilars increased as a proportion of total net sales to 29%, compared to 27% in the first half of 2024. When looking at the Q2 performance itself, we hit the 30% target, the milestone that we have achieved earlier than expected. Our regional sales mix has remained broadly unchanged with over half of our business in Europe where we hold a strong leading position. International represents 1/4 of net sales with 21% coming from North America. Now let's dive into the performance of the business on Slide 20. Generics sales increased by an underlying 2% in the first half and by 3% in Q2, reflecting the impact of recent launches, including paclitaxel in North America. Biosimilars delivered very strong underlying growth of 20% in the second quarter and of 17% for the first half. We were very pleased with this performance and strong progress that we are making with our biosimilars overall. Now let's have a look at the performance of our 3 regions on Slide 21. Europe sales grew by 6% in the quarter and in the half year. Strong growth in biosimilars continued, partly reflecting the successful launches of Pyzchiva and Tyruko. Generics momentum also accelerated in the second quarter. International sales grew by an underlying 13% in the quarter and by 8% for the half year due to strong contributions from Hyrimoz and Omnitrope. North America sales grew by 5% in the quarter and by 4% in the half year on an underlying basis. The region benefited from the strong generics performance, and we look forward to the impact of recent launches on the performance in H2, including denosumab. Please turn to Slide 22. In breaking down the sales performance for H1, you can see that volumes contributed 7 percentage points while price erosion returned to a more familiar 3 percentage points. Foreign exchange had no impact during the period. Let's now move to the P&L overview on Slide 23. I'm particularly pleased with the leverage we drove down the P&L in H1, producing strong profitability. Starting from net sales growth of 4% at constant currency, we delivered a 33% increase in core diluted earnings per share. The core gross profit margin of 49.2% represented a decline of around 1 percentage point, reflecting price erosion and some cost inflation, which were partly offset by an improved mix. This, combined with the impact of operating leverage resulted in a core EBITDA margin of 20.0%, which represented a 20% year-on- year improvement in core EBITDA. Core EBITDA adjustments in H1 amounted to $176 million. This compares well to the $309 million in core adjustments in H1 last year. This year, adjustments were driven by anticipated one, of course, related to the separation from our former parent and the rationalization of internal manufacturing sites. For the full year, we're still expecting one-off costs of around $500 million. Please turn to Slide 24. Moving to the core EBITDA margin performance, we drove an increase of 2.5 percentage points from 17.5% to 20.0%. We delivered a favorable product mix that was partly offset by the impact of price erosion. Focus on cost leverage and discipline meant a positive impact on the margin from SG&A and D&R expenses, while foreign exchange movements had only a marginal adverse impact in the period. Please turn to Slide 25. It's worth noting that we anticipated that the core EBITDA margin will further progress in the second half, partly reflecting continued improvements in the sales mix. We also see operating leverage continuing to deliver with OpEx inflation set to remain below net sales growth. The year-on-year uplift in E&R expenses in the second half is expected, however, as we invest in the long-term growth of our pipeline. As a result, we expect our full year 2025 core EBITDA margin to be around 21%, reflecting our ability to drive profitable growth while managing costs. Now let's move to cash generation on Slide 26. To provide more insights on our underlying free cash flow, we exclude one-off items when focusing on management free cash flow. As Richard mentioned, we have continued to invest in our future. CapEx included ongoing investments in our biosimilar facilities in Slovenia and there were also investments in facilities and technology. Importantly, we have not changed our view of midterm CapEx commitments. We have been able to keep our inventory flat in constant currency and limit increase in other working capital items. This led to the doubling in management free cash flow, which also reflected the increase in core EBITDA. Free cash flow of $207 million compared to $21 million generated in the comparative period last year. The improvement was mainly due to increased net cash flow from operating activities, partly offset by higher cash flows used for CapEx. Please turn to Slide 27. Now let's have a look at our balance sheet. Earlier in the year, we successfully strengthened our balance sheet and improved our maturity profile by issuing new bonds to repay the spin-off term loans. At the same time, we signed a new $2 billion revolving credit facility. Both transactions give us continued financial leeway going forward with the annual interest rate on gross debt expected to fall below 4%. A substantial weakening U.S. dollar against the euro and the Swiss franc had an impact on net debt, which ended the period at $3.9 billion. When excluding the impact of foreign exchange, however, net debt was broadly unchanged. Our strong balance sheet and investment-grade credit ratings have placed our company in a very good financial position to support our ambitions. Please turn to Slide 28. I'm pleased to say that we have reiterated our full year guidance today. We continue to expect net sales to grow by mid-single-digit percentage points In constant currencies this year with the core EBITDA margin set to increase this year to around 21%. The guidance is based on 2 key assumptions. Firstly, we continue to expect a return to more normalized levels of price erosion of a low- to mid-single-digit percentage. Secondly, we prudently assume that the announced U.S. tariffs of the EU of 15% will be confirmed as applicable to generics and biosimilars. That will take the total impact this year to around $25 million. Given the anticipated shape of the business in 2026, we would expect an additional $45 million of impact over full year 2026, taking the total impact next year to around $70 million. Outside of guidance, we anticipate that if the latest spot rates were to prevail for the rest of the year, we would see a 2 percentage point tailwind to net sales over the full year. The core EBITDA margin would continue to face a limited adverse impact of less than 50 basis points, which will be in line with what we had in 2024. If you look at currency movements based on average rates in the first half, we would anticipate an immaterial impact on both net sales and on the core EBITDA margin. And with that, I will hand back to Richard. Please turn to Slide 29.
Richard Saynor: Thank you so much, Remco. I'd now like to wrap up the presentation before we go on to questions. Please move to Slide 30. In summary, we've delivered strong results in the first half of the year driven by great execution, our focused strategy and our commitment of our teams across the board. I would like to thank all our colleagues at Sandoz for their fantastic efforts so far this year. As we look to the second half, we're excited about the momentum we've built and the opportunities ahead. With several key launches planned, H2 is shaping up well. In short, we're fully on track to deliver our full year commitments. Looking ahead, we will also continue to invest in long-term opportunities that will shape our future growth even further, centering on biosimilars. For this, please turn to Slide 31. I'd like to conclude our presentation with a reminder of a huge number of opportunities that lie ahead, and these are at the heart of the Sandoz investment case. Today, we have an industry-leading biosimilar pipeline of 27 assets, covering around $200 billion of originator sales. Through a combination of in-house development and partnerships, we've been able to triple the size of our pipeline over recent years. Our investment in and focus on expanding the pipeline is now accompanied by the exciting momentum in regulatory streamlining and the enhancement of our development and supply capabilities. Our generics pipeline has more than 400 assets in development, covering around $220 billion of originator sales. No one single medicine makes up a material amount of our generics sales, so our large scale and robust infrastructure allows us to continually bring new generic medicines to market. And longer term, we also have the significant prospects from GLP-1s. We're placed to take a leading position of all of these opportunities, and I look forward to updating you on our progress. With this, please turn to Slide 32 and I will ask the operator to open the line for Q&A.
Operator: [Operator Instructions] Our first question comes from James Gordon with JPMorgan.
James Daniel Gordon: James Gordon, JPMorgan. First question with semaglutide. So hopefully, now less than 12 months from a Canadian launch. So can you provide an update on timing? And do you have a device or a device you can use [ for ] capacity? and are you also on track to Brazil next year? And where might that launch be as well, please? Second question was just biosimilars in North America was a little bit softer, at least versus consensus for the quarter. How are you thinking about that into H2? Should we see an acceleration already in H2 or is it more like late in the year we get the acceleration? And is there a bit of a pipeline gap for North America or does next year look good for U.S. biosimilars? And if I could just squeeze in a clarification. Other income looked a bit better today even on a core basis and other expense a bit lower. But was there anything one-off there? Or is the H1 number a good guide for H2?
Richard Saynor: Okay. Thank you so much. So semaglutide, I mean, look, we've filed, we would anticipate to launch market formation, again, reminding everybody for the diabetes indication, not for the weight loss indication. We've not given details about the device or volumes. Again, I've always said, look, I see Canada as a bit of an experiment. We'll see how the market evolves. We've got no idea how as prices come down, market expands. And so we'll see as we get there. I mean, clearly, we would anticipate to launch in market formation at some point during 2026, but we'll see when we get there. And similarly, with Brazil and a number of other emerging markets, again, we would anticipate to launch probably late '26, early '27 and see how that evolves again, how elastic this market is going to be. Depending on pricing, we will see. U.S. biosimilars, yes, I think, look, again, we would expect much stronger growth in the second half. Underlying growth actually is very strong. If you strip out the Cimerli impact, I think we were growing about 9% in the U.S. and about 17% in total. So very strong underlying performance. And then clearly, we would give more detail in the deno and ustekinumab launches as we get into the second half of the year. Again, I would sort of caution when we launched adalimumab, it took about 9 months before we started to see an inflection. So these things don't happen quickly. Again, I think we're well positioned. We're pleased with the coverage that we've got. And I think we're well positioned for the second half of the year. I'm sorry, your third question. I was just making notes.
Remco J. Steenbergen: Yes, I can take that. James, Remco here. It was around the other income. Let me answer, and then if you have another question, Richard will pick up again. The other income in H1 was around $20 million. There were different kind of one-offs in there. Last year, it was negative. So the year- on-year comparison is an improvement. Yes, that other income could be a couple tens of millions, plus or minus depending on the half year. Nothing special to be mentioned here.
James Daniel Gordon: So it sounds like in H1, there wasn't anything exceptional that was one-off and H1 is roughly a guide what you do in H2 for this line in the P&L?
Remco J. Steenbergen: At this point in time, yes, something -- what I said, it could be $10 million, $20 million-plus and $10 million, $20-million in the minus depending on the smaller items going on, but nothing special here.
Operator: Our next question comes from Harry Sephton with UBS.
Harry Thomas d'Alton Sephton: Brilliant. So my first one is on the sequential biosimilar performance. Can you say if there are any significant stocking or destocking dynamics in biosimilars across the first quarter and second quarter, especially in some of those new launch markets in Europe? And my second question is on the Evotec proposed acquisition. Now their press release stated that the divestment would be immediately accretive to short, mid- and long-term revenue mix, profit margins and capital efficiency. So I'd like to get your view on why you will be the better owner of this asset and whether it will have any near-term dilutive effects. And then if I can quickly have a third question, just on a clarification. Can you just remind us on how much more you're expecting in terms of separation costs? And are the last of these still expected this year?
Richard Saynor: Perfect. Thank you, Harry. I'll take the first question, and have Remco, I'll let you pick up the Evotec and the separation costs. No. I mean, look, clearly, we had a number of launches in a number of markets, but I don't think anything material in terms of stocking or stock in trade was unusual given those launches. So I wouldn't see any impact to H1, H2 from that going forward. Evotec?
Remco J. Steenbergen: With regard to Evotec, what we have said is that our guidance for '25 and also our midterm guidance is unchanged, correct? At this point in time, what we see if that -- if the nonbinding comes to a binding agreement, what we believe is that clearly, the site would be mostly allocated for us anyway. So it's probably better if we run it and we get all the capabilities internally and therefore also have the flexibility when we talk on the mid, longer term to really capitalize on the capabilities. There's the capabilities on the development side and the capabilities on the manufacturing. And we believe we can handle that all within our current guidance as it stands now. Of course, it's an additional activity we take on our shoulders that we believe we will be definitely a very good owner in order to drive this forward as the largest bio player already now. With regard to the last question, the separation costs, we had $176 million of cost in H1. We still expect around $500 million for the full year. The majority of the $176 million relates to still the IT disentanglement. We continue -- we expect that to continue in H2. We still have transformation costs and also some manufacturing-related restructuring we expect in H2. But also to be mentioned that in H1 we had actually some positive legal benefit coming in. Normally, that's negative. Here also to mention that also when it's positive, it comes in that line item. So many thanks to our legal team here in Sandoz. I hope that answers your questions, Harry.
Operator: Our next question comes from Simon Baker with Rothschild & Co Redburn.
Simon P. Baker: Three quick ones, if I may. Just going back to James' question on obesity, but rather broadening it out. It's clearly been a fairly eventful market recently. So I just wonder how your view of the opportunity has changed in light of what we've seen in terms of the demand, the growth trends in the U.S., issues in international markets, the clear power of prices we see from the compounders in the U.S. Just a sort of an update on how you frame the opportunity from a Sandoz perspective. Secondly, on the regulatory streamlining, you cited the impact on biosimilar pembro, ocrelizumab and nivolumab. Longer term, you've said it will effectively allow you to do more for the same amount of investment. So in the near term, how quickly can you do more if you're spending less on those assets? I'm just trying to think how the costs of development are going to evolve over the coming years, whether you can immediately take advantage of that or whether there's a dip in spend before that manifests itself. And then finally, just a quick one. I know it's been on the slide for a couple of presentations, but Enhertu as a development target, Astra have said that they expect biosimilar penetration for ADCs to be limited because of the sheer complexity of them. I just wonder what your perspective was, Richard, on the competitive dynamics in ADCs. Do you see this as being a market with far fewer players than a traditional biosimilar?
Richard Saynor: Thank you. I'll start with the last question first. I mean, they would say that, wouldn't they? I mean, the originator industry has been saying that since I started in this business. They said that about biosimilars, they said that about pretty much every product that we've launched. I think we are strong in this therapy area. We have the relationships. Payers want the product. I'm very confident that when we bring this product to the market, we will open that market up and serve patients well. Obesity growth trends, look, I think your guess is as good as mine. I think, clearly, this is a highly attractive product. As I said before, in my many years in the industry, I've never known a product where the originators can actually meet the demand at a different price point. So I think really the question behind the question is what is the available capacity, how quickly can that come onstream and how rapidly that market opens up? And I think that's going to be very dependent by the individual markets. Some markets like Brazil are very much out of pocket, and I think has a rapid potential to expand. Other markets will be driven more by government payer frameworks who want to see more whole population treatment patterns going on. It really is too early to say. Originally, when we put -- I think the first Capital Markets Day, we didn't even talk about GLP-1s. I think now every meeting I have I talk about GLP-1s. Clearly, it's evolving. Our focus is clearly to bring to Canada for the diabetes indication, as I say, use that as a test case and then think about how we expand that. And then Europe doesn't really start opening up until 2031 and then the U.S. till the mid-2030s. So this is a long game. And clearly, it's going to be interesting how that plays out. Your question on regulated, yes, I mean, clearly, look, we see opportunities very rapidly. I mean, I think we said -- I said in my presentation I'm very keen that we build on a world-class pipeline already. We have 27 assets. As we see savings and certainly in some of the reduced requirements in Phase III trials, we would look to reinvest that as aggressively as possible to expand our pipeline. We see a significant opportunity to continue to leverage and grow and bring and expand our pipeline over the next few quarters.
Operator: Our next question comes from Florent Cespedes with Bernstein.
Florent Cespedes: Florent speaking from Bernstein. Two big picture questions, please. On biosimilars pipeline, when we look at the slides, we see that for the future, you have a lot of partnerships, not -- much less in-house. So maybe could you elaborate on what could be the impact on the margins on the medium term? That's my first question. And second question, another big picture question on biosimilars. When you look at the penetration market share, it's kind of plateauing over time. So is it -- what could be done to increase your market share? Or is it fair to assume that you will grow first with the further penetration of the biosimilars? So any color on that would be helpful.
Richard Saynor: No, look, 2 important questions so thank you, Florent. In-house, I mean, look, we already -- as we separated from Novartis, we're investing heavily in our own in-house capability, both in Slovenia and clearly with the proposed acquisition of Just-Evotec. That means that then we can continue to expand what we develop in-house because clearly in-house products in the medium and long term are much more accretive. That said, what's becoming very clear as the leader in this space, more and more companies want to work with us. And so it's much more can be capital efficient to bring in other assets that we can continue to leverage. If you look at our performance with ustekinumab, which we partnered with Samsung, already now we've taken the leadership position in Europe, growing very strongly. And now other companies are seeing the benefits that we can come given our scale and capabilities. So still highly attractive. Our job is to bring as many products to patients as quickly as possible. And clearly, by doing that as a combination of in-house and partnership and in licensing and a mix of all 3 is important. In terms of market share, I think it's 2 dimension. I mean, clearly, as other entrants come in, market share dynamics change. But also don't forget the market itself is growing substantially. If you look at the adalimumab market today in Europe, I think it's now more than twice the size in number of patients than it was at market formation. So don't just look at the absolute percentage market, but also look at the size of that market because it's continuing to grow. If you look back at Omnitrope, we launched human growth hormone 20 years ago, now we have a 35% market share, still growing and we're the world's largest supplier of human growth hormone, which, again, I think we've said before, really shows the strength and depth and value creation that biologics bring over a much longer cycle compared to traditional small molecule generics.
Operator: Our next question comes from Thibault Boutherin with Morgan Stanley.
Thibault Boutherin: First question is just on the -- from a strategic standpoint, the balance of geographies. At the time of spinoff, the U.S. was framed as a clear growth driver. I think U.S. framed as being half of the growth opportunities. I think since maybe we saw a bit less growth in the U.S., a bit more ex U.S., ex U.S. is closer to 80% of sales. So since these initial plans, have things changed? And do you do no more expect the growth to be balanced between U.S. and ex U.S.? So should we think basically about the outlook a bit differently from a geographic perspective? That's the first question. And then second question, I just want to broaden a bit the previous question on the adjustments and about earnings quality and basically the free cash flow as well. So you talked about the expectations for second half of the year, but when we think about 2026 and onwards, how should we think about the pace of reduction of adjustments in the future and transitioning from the management adjusted free cash flow measure to a more standardized measure of free cash flow. So basically, the pace of normalization going forward.
Richard Saynor: I'll let Remco pick up those. So thank you so much, Thibault.
Remco J. Steenbergen: Yes, first of all, at the moment of spin, we had a lot of assumptions with regard to the bio growth, the generics growth, the regional growth this year. Clearly, we see that Europe is doing fantastically. So Europe with 50% of the overall is actually contributing 50% of the total. We have now to see what will happen in the coming years. It might be that Europe is continuing on this very, very strong growth. And certainly, that we hope for. That would mean that perhaps the mix in the overall growth over the coming years will change a bit. For us, it's important that the overall company can grow the mid-single-digit growth. And of course, we will try to do better than that. Yes, if that's in a different mix, it's fantastic. If we are a little bit less dependent on the United States, considering the current geopolitical situation and the tariffs, I would say that's not even a bad thing. That's actually a good thing. But it's too early to call that we already changed the overall growth. But certainly, we believe we're in a very good position. With regard to the one-off costs, yes, what we said before is around $500 million this year, then going to around $100 million next year and then it should stop. We're still in that position. We still expect some of the IT changes still to take place next year with regard to SAP systems in our factories, and that will carry some cost. And then after that, it's gone. And then, of course, the managerial free cash flow and the reported free cash flow and the same on the margin would much more convert to a closer number. So no changes from what we said before. We are on track with this. Thank you, Thibault.
Operator: Our next question comes from Joris Zimmermann with Octavian.
Joris Zimmermann: This is Joris Zimmermann from Octavian. Richard, Remco and team, congratulations on this set of numbers. Two, if I may, one on the U.S. biosimilars performance. Here if you could share a bit more flavor to the launch products? So similarly, you said this is on a temporary hold. Is it still the plan to relaunch early next year? And then on Hyrimoz, if I remember correctly, you mentioned increased pricing pressure in the last call. So here, I would be interested in understanding how this has developed. And then the last one on the U.S. biosimilars is concerning Pyzchiva. Can you share a bit more details about the private label deals? Which partners you've closed those deals? And then the last question would be on the manufacturing expansion, so to say, and your announced plans with the additional site in Slovenia and the acquisition of the site from Just-Evotec. If you could just help us understand the difference of the 4 sites a little bit more and how that integrates into your broader plans, also including the Novartis manufacturing capacities that you currently use?
Richard Saynor: Thank you for the comments around our performance. Yes, we're clearly delighted. So thank you. U.S. biosimilar, yes. I mean, similarly, obviously, we're on a pause. Actually, the underlying growth in the business is pretty strong, but that clearly at a headline level distorts the numbers a little bit. We would anticipate to reintroduce that product probably late this year, early next year and then slowly build that up. Hyrimoz, yes, I think, look, clearly, this is a highly competitive market. That said, we're by far, have by far the best payer coverage. We have the leading position in terms of market share with our own product, both branded and unbranded ada. And then clearly, we have the partnership deal, which, again, clearly is subject to price renegotiations. So it's a mixture of those things. We don't break out individual products or individual market pricing, but clearly, this is a competitive market. But I'm pleased in terms of position that we've built. And similarly, with Pyzchiva, we've not disclosed the details, but clearly, this is structurally a different product. This is an in-licensed product from Samsung. So it's a partnership deal rather than a vertically integrated product. In this case, we don't actually book the top line. We only book the income and then clearly we have our own product. Again, it's too early to share in terms of market share assumptions and performance. But again, early indications are we're pleased with the coverage that we have and would expect that to build in the following quarters. So again, we hopefully give you a little bit more color on that on the next earnings call. In terms of manufacturing capacity, I think with the investment in Slovenia, I mean, we have a long history in Slovenia anyway. We have a very good relationship. I think it's a high-quality, relatively low-cost location in Europe. Our ambition there is to build both drug substance and that was the initial announcement in terms of that development capability, which we've also built there. And our most recent addition was drug product, i.e. fill/finish, which can be clearly used for other products as well, potentially GLP-1s in the future as well. So really thinking about a vertically integrated capability, co-locating development and manufacturing in one location to make it as efficient as possible. Our goal there originally was to put potentially a J.POD in from Just-Evotec, transfer a number of assets, which were currently supplied from Novartis as well as using that from development. Obviously, with the potential acquisition of Just-Evotec, that means we then also get additional development capability and also additional manufacturing capacity, particularly centered around the J.POD and continuous manufacturing. I think that then positions us extremely well, both in terms of existing portfolio, but more importantly, for our future portfolio. And in terms of our relationship with Novartis, clearly, we have a long-standing supply agreement with them. If we wish to, we may choose to continue to leverage that capacity in various forms beyond the sites, our sites coming onstream. I think I've always said I want to build security of supply and flexibility of supply. Novartis had been a good partner and potentially we would continue to look at that. But I think we'll have that conversation when we get nearer to the time. But that, in essence, is our manufacturing strategy. Thank you so much for your question.
Operator: Our next question comes from Charlie Haywood with BoA.
Charlie Haywood: Charlie Haywood, Bank of America. First one, your guide implies second half sales acceleration to a sort of 6% constant exchange rate, in line with your first half underlying. Could you talk to the pushes and pulls for that sales growth into '26? I guess, is the second half 6% CER sales rate a good exit rate proxy to think of that '26 growth rate? Or could we even see an acceleration from annualizing biosimilar launches, sema and your Cimerli relaunch? And then the second one, obviously, 20% first half margin, 21% for the full year, how should we think of your annual cadence to your midterm '24 to '26 margin guide by '28? And how much of that margin progression is still driven by post-spin efficiencies versus underlying mix and operating leverage?
Remco J. Steenbergen: Yes. Charlie, the line was not 100% correct, but I think I understood your question, so I will take them. Remco here. So indeed, we had in H1 around 4% sales growth for the full year, we guide mid-single digits. So depending, that is then 5% or 6% because we expect a step-up in H2. You talked indeed in the range from 6% to 8% in H2, that would be mathematically correct. We don't give guidance yet on '26, so I don't comment. But clearly, the midterm guidance is mid-single-digit growth. So that is still what we're striving over the years through '28. And for '26, you have to wait a little bit later in the year. With regard to the profitability in H2, yes, indeed, we expect a step-up in H2 versus H1 to come to the 21%. What is important to keep in mind that in H2 we will step up our D&R expenses versus H2 last year. So also for the others on the call that -- and I'm talking not only in amount, I'm talking also in percentage because we want to make sure that not only we handle the short term, but we also really invest in the longer term. And we have a little bit of an impact on the margin of the FX because of the U.S. dollar-euro impact. So that's also a little bit of step- up versus H2 last year. That corresponds then with around 21% for the full year, and we have to see how that then further develops because we have some fantastic launches planning. But we are very confident with the H1 results under our belt that we can meet our full year guidance. Further out for '26 or '27, '28, we expect a progressive growth on the margin to come to the 24% to 26%. Again, it's too early to say anything on the individual years, but we are really, really confident that we can meet those targets and well on track. So I hope that answers your questions, Charlie, and understood them well.
Operator: Our next question comes from Victor Floch with BNP Paribas.
Victor Floch: Victor Floch, BNP Paribas. So 2 questions on GLP-1 actually. So first of all, Richard, you recently alluded to the fact that Canada being the second largest semaglutide market in the world likely reflects some cross-border business dynamics. So in this context, I was wondering if you expect that the Florida drug importation program could be extended to GLP-1 at some point? And if that could potentially pave the way for more U.S. states to apply? And my second question is still on GLP-1. I'm interested to know if you can confirm if ever the semaglutide API that you source is manufactured through chemical synthesis or same way as the originator through yeast cell production?
Richard Saynor: Thank you very much, Victor. I mean, we've not commented on the manufacturing process in terms of API. So we actually have a couple of partners on that. And again, we can discuss that closer to launch. Your question on -- I mean, again, I think I try to be super cautious in terms of how I view GLP-1s in Canada. A, we were only focusing on the diabetes indication; b, we've got no assumption that we would be shipping cross-border. I have no intention of getting injuncted by anybody. So in all our planning assumptions, it's very much diabetes and very much for Canadian use only. As I said, this is an experiment. We've not put any guidance in terms of numbers, expectation. This is a whole new category and opportunity. I would much rather have a modest expectation in terms of how we view this and then build on it rather than see this as transformational for the business. So I think it's important. I know I get a lot of questions on GLP-1s. But again, we see this very much opportunistically at this point. We'll see how Canada evolves. Clearly, it's a unique set of circumstances given the lack of patent or the failure of the patent there. And then as the various data exclusivity on weight loss and diabetes fall, but again, our focus diabetes for the Canadian market.
Operator: Our final question is from Sidhartha Modi with Barclays.
Sidhartha Modi: Sidhartha Modi from Barclays. Two, if I may. The first one is on Wyost and Jubbonti, which you have launched in the U.S. Obviously, the discount to branded products is much lower compared to what we have seen for Pyzchiva and Hyrimoz. But then this space is very, very competitive and a lot of new entrants would come into the market in the second half. How do you expect the price erosion? And how would you position yourself to defend a large share of market share? That's my first question. And second like recently a lot of manufacturers, branded manufacturers, have been talking about DTC sales. How does that impact Sandoz? And what are your takes on DTC sales from branded manufacturers in the U.S.?
Richard Saynor: First of all, thank you for your questions. I mean, look, we are at the moment with Wyost and Jubbonti, we're the only one with a Q code. We're the only product that technically can be reimbursed. None of our competitors yet have yet got a Q code. I would point to our performance in other biologics. If you look at how we perform both with ustekinumab and it's an in-licensed product; and adalimumab, which is a vertically integrated product; as is denosumab, I think we're extremely well positioned to leverage our commercial capabilities and channel capabilities. Yes, it's a competitive market. We're used to competition. And so -- but in terms of how I expect price erosion, really we'll see how that evolves in the latter part of this year. But certainly, we're in a position, a, to compete in terms of our cost of goods; and b, to execute in terms of our commercial footprint. DTC, it's a fascinating subject. I think, clearly, I'm watching with interest to see how other competitors look at exploring this space. Clearly, I think one of the issues in the U.S. is the middlemen and any mechanism that potentially changes that is interesting. Certainly, something we've not explored at the moment, but it is something that I would watch with interest. Thank you so much for all your questions. Thank you for your time today. And apologies if we started a little bit late, very un-Swiss of us. But thank you so much for your time.
Operator: This concludes today's call. Thank you, everyone, for joining. You may now disconnect.