Sandoz Group AG (SDZ) Earnings Call Transcript & Summary
September 8, 2026
Earnings Call Speaker Segments
Craig Marks
executiveSo before we begin, I'd like to just cover some practicalities. In the event of an emergency, please whatever you do run and also leave the room immediately. If you hear the words at evacuate event staff can be on hand. If you require assistance or notice any issue please alert a member of staff. Now you'll find Wi-Fi details on your badge for easy access in your goodie bag you'll also find a copy of the slides to write on. If you're joining via the webcast, you're very welcome to participate in the Q&A sessions. We have two. Please submit your questions using the Ask a Question function. And finally, please note today's session is being recorded and a replay will be available on the website soon. Now you can see our disclaimer here. Let me briefly walk you through today's agenda. Gilbert Ghostine, our Chairman, will kick off by outlining how we're translating our potential into excellent progress. Richard, our CEO, will then take you through how we will enhance our long-term growth and profitability. He will be followed by Rebecca who will explain why Sandoz is best positioned to make the most of the upcoming loss exclusivity opportunity in biosimilars by accelerating our leading pipeline. And Armin, our President for biosimilar development, manufacturing and supply, we'll focus on how we are scaling biosimilar development and driving vertical integration of our manufacturing and supply network. Now following Armin's presentation, we'll pause to cover any questions you have and then we'll have time for a cup of tea. When we come back, we'll shift to commercial execution with our three regional presidents, Christophe, Peter and Keren for Europe, international and North America, respectively, will bring our world-class commercial engines to life for you. Remco, our CFO, will then take you through how all of this will translate into attractive and sustainable value creation for our shareholders, but even more importantly, into value for the patients we serve. Now Richard will close the presentation, and then we'll move to the final Q&A session where we'll finish, we think, around 5:00 U.K. time. For those in the room, we will be delighted if you could join us for drinks outside. And with that, it's my pleasure to hand over to Gilbert.
Gilbert Ghostine
executiveThank you, Craig, and thank you all for joining us here today. It is an honor to be with you all. Moving from promise to performance. At Sandoz, our ambition has always been clear to improve patient access to medicines around the world. Over the past 3 years, we have sharpened our focus, prioritize the right medicines, strengthened our development engine and built a more resilient scalable supply network. At the same time, we've become more disciplined commercially, capturing the full value of our portfolio. What defines Sandoz is not a single attribute, but a combination of strength that few companies can match. We are a company built on leadership in biosimilars and generics on scientific innovation, on quality and integrity and on a deep commitment to patients. Our Swiss heritage gives us strong foundations, but our impact is global. Every day, our medicines reach millions of people around the world and help health care systems expand access to treatment. At Sandoz, these principles are not independent of one another. Innovation without access has limited impact; scale without quality cannot be sustained; leadership without integrity cannot endure. The strength of Sandoz comes from bringing all of these elements together. That combination has allowed us to build a leading position in biosimilars and generics and has made Sandoz one of the most respected companies in affordable health care. As we look ahead, this strength will become even more important. Health care systems need partners that can deliver innovation, quality, reliability and access simultaneously. We believe Sandoz is uniquely positioned to do that exactly. 2026 marks a special year for Sandoz. It brings together three significant milestones, 20 years of pioneering leadership in biosimilars, 8 years at the forefront of antibiotics and 140 years of Swiss heritage rooted in entrepreneurship. These anniversaries are about more than longevity. They reflect our ability to adapt, innovate and remain relevant in a constantly evolving health care landscape. Over the decades, Sandoz has continuously adapted to scientific advances and societal needs from expanding access to life-saving antibiotics in the mid-'20s century, to scaling complex biologics today. The company has grown alongside breakthroughs in medicine and alongside the patients it serves. This progression is underpinned by a clear and enduring ambition, improving access to high-quality affordable medicines worldwide. While Sandoz began its latest chapter as an independent publicly listed company only in 2023, we stand on the shoulders of giants. The company traces its origins back to 1886 in Basel, a legacy shaped by generations of pioneers, entrepreneurs and creators who laid the groundwork for what Sandoz is today. The three anniversaries we are celebrating this year tell us that story. Over 140 years of heritage gave us the entrepreneurial spirit to adapt and evolve. Our 8 years of antibiotics demonstrate our ability to bring essential medicines to patients at scale, and our 20 years in biosimilars show how we continue to lead in some of the most complex and innovative areas of health care. Together, these milestones are more than markers of our history. They are the foundation of the impact we delivered today and the ambition we have for tomorrow. The reason these milestones matter is not simply because they reflect our past. They matter because of what they enable us to do today. In 2023, we set out to become an independent company. Today, we could proudly say that we have delivered on the commitment we made and most importantly, that we are living up to our purpose of pioneering access for patients. The same strength that allows us to strive for 140 years, lead antibiotic for 80 years and pioneer biosimilars for 20 years are now translating into measurable impact for patients and health care systems around the world. Biosimilars and generics account for around 80% of global prescriptions, yet only about 30% of their total cost. This is why access and affordability matter. In 2025, we reached more than 1 billion patients. We delivered USD 26 billion in health care system savings and generated an estimated $400 billion in broader social impact. Looking ahead, we are significantly raising our ambition. We see a clear path to reaching over $1 trillion in social impact through accelerated portfolio expansion, increasing biosimilars penetration and our expanding global scale. This is ambitious. But after you hear the rest of today's presentation, I believe you will also see it is realistic. Sandoz is not only a growth and a margin story, but also a company uniquely positioned to benefit patients and health care system at an unequaled scale. As we build on our rich heritage and prepare for the opportunities ahead, we have also evolved our leadership team. Since listing, seven members of our Executive Committee have either been appointed or changed positions, bringing additional capabilities in the areas that are critical as we further develop our business. Commercial excellence, biosimilars, manufacturing, supply chain and financial discipline. What you see here is a highly experienced and globally diverse executive committee, bringing together deep expertise across commercial, science, supply network, finance, legal and intellectual property with a strong track record of execution where scale, discipline and operational excellence matter most. The Board fully supports the Executive Committee, and I'm extremely pleased with the performance of the team and the platform they have constructed to deliver this new and exciting phase in our history. The first 3 years were about building the platform. The next decade is about capturing this opportunity. Turning to our Board. All our directors are independent, providing objective oversight and supporting balanced decision-making. This is a Board that combines independent experience and diversity, providing the governance framework, we need to execute our strategy with discipline. I'm honored to serve as Chairman of Sandoz, and at the same time, very proud of the Board we have assembled. I'm also grateful for the strong support it provides Richard and the Executive Committee. With the right governance, the right leadership team and a clear strategy, Sandoz is well positioned to capture significant opportunities ahead. Together, Richard and his team have built a strong platform over the past 3 years. Today, you will hear how we intend to build on that momentum and further accelerate our impact for patients, health care systems and shareholders. And with that, let me hand it over to our best CEO, Richard Saynor. Richard, over to you.
Richard Saynor
executiveA bit hard to live up to. Thank you so much. So it's a real pleasure to be here, and thank you so much, Gilbert, for the introduction. I'm incredibly proud and privileged to be here today. As you heard from Gilbert, since we launched the first ever biosimilar 20 years ago, we have shaped and defined the global biosimilar market. We've built the industry's broadest portfolio, delivering medicines across a range of therapy areas and serving patients globally. Today, we stand at the beginning of our golden decade of opportunity with an unprecedented loss of exclusivity. The originators talk about a patent cliff. Their patent cliff is what we see as Sandoz as golden decade. More importantly, it is the golden decade for people like Cheryl whom you just watched on the video as more patients will have more access to affordable medicines. In the last 3 years, we have established our business credibility, our global scale and the value that we add to patients and the health care systems around the world. Now we can do so much more. We are already a leader in our field, but we can accelerate and amplify that leadership. BIO 100 is how we will meet this huge opportunity. It is a clear strategy for how we will deliver more than 100 biosimilars to the market by 2040, supported by a vast and vertically integrated development, manufacturing and supply engine. This is not just a pipeline aspiration. It is a comprehensive, clear plan that will shape how we will invest, how we will operate and how we will grow over the next decade and beyond. There's only three things that you should leave with today. Firstly, our purpose. This remains the same. We remain driven by our purpose and committed to expanding access to high-quality affordable medicines and driving meaningful benefit for millions of patients like Cheryl. Second, we have a clear ambition to be more that have more than 100 biosimilars in the market by 2040. This scale will enable us to broaden our reach, deepen our presence across therapy areas and drive long-term sustainable growth. And thirdly, along the way to our 2040 ambition, we have a clear delivery plan on how to at least double net sales by 2035 versus last year and deliver a core EBITDA margin above 30%. That margin will be one critical element, although not the only one of our long-term value creation. We are building high-growth biosimilar platform designed to provide differentiated capabilities at scale. The following presentation will show you how Sandoz is in a unique position and how we're turning this ambition into reality. We are focused on two businesses where we have a clear competitive advantage: biosimilars and generics. Together, they create a complementary and resilient platform, combining innovation, scale and cash generation. Critically, we have the proven capabilities to deliver. We have the commercial reach and the financial strength to invest a leading and expanding pipeline, strong development platforms and strategic partnerships, a robust global manufacturing and supply network, deep regulatory and IP expertise and, as I said before, financial strength to continue that investment. This consistent strategy is already delivering. And with the same fundamentals now we can do so much more. Looking ahead, we're significantly raising our vision. As Gilbert already mentioned, we see a clear path to reaching over $1 trillion in social impact, and delivering high-quality affordable medicines to ever more patients. And why do we believe it? Well, the best place to start is our track record. We are the largest pure-play generics and biosimilar company operating at scale worldwide. This scale matters as it gives us the relevance with our customers, leveraging our operations and a strong foundation for future growth. At the same time, we are a true European championship with leadership positions in around 95% of the markets that we serve and a presence in Europe of over 40 markets. This breadth and scale deliver both a huge competitive advantage and a significant expansion potential. Importantly, our growth is consistent and proven. We have now delivered 19 consecutive quarters of top line growth driven specifically by our biosimilar business. In addition, we've delivered strong operating margin expansion, a core EBITDA of 21.7% last year, representing a near 4 percentage point improvement since we became an independent company. Underpinning all of this, we have developed the strongest pipeline in the industry with 39 biosimilars and more than 300 generics, giving us clear visibility on future launches and strong momentum. And finally, our global footprint is comprehensive, serving more than 100 markets. I hope that you will agree that Sandoz has a unique combination of pipeline breadth and commercial scale, backed by a strong financial position. In terms of our sales growth, we started at $9.6 billion in 2023, and we've reduced a compounded growth rate of 7% at constant currencies. Biosimilars continue to be a key driver while our generic business provides scale, resilient and strong cash generation. You can also see the increased contribution and momentum from biosimilars. Our sales growth and increased profitability reflects excellent value drivers. Firstly, pipeline execution, ensuring successful launches. Secondly, the strength of our portfolio with increasing contribution from higher-value biosimilars. Thirdly, a continued focus on operational excellence across the supply chain. And finally, ongoing organizational efficiency as we simplify and scale our business. And we see a clear path to further margin expansion. With around $15 billion in gross sales, we are significantly ahead of our closest competitors. Importantly, this leadership is not concentrated in just one region. It is global, spanning Europe, North America and international markets, reflecting both scale and diversification. But what differentiates Sandoz more than anything else is our end-to-end integrated model. We combine deep capabilities across development, manufacturing, the supply network and business development and then commercialization allowing us consistently to bring biosimilars to market and scale them effectively. We've been building this opportunity for several years now. We've committed to around $1 billion to build a leading fully integrated European biosimilar hub. This was a deliberate strategic decision to invest ahead of the opportunity and create another competitive advantage. This delivers a highly differentiated end-to-end platform spanning technical development drug substance, fill/finish manufacturing, all anchored in Europe. You're going to see this across our footprint with Ljubljana as a core development hub lender for drug substance production, Brnik for injectables and manufacturing and Toulouse as an important development and supply network center, complemented by additional capabilities in Germany and the U.K. We've created this network so that we have control, speed and reliability needed to internalize biosimilar manufacturing and strengthen our capacity for growth. It allows us to accelerate development time lines, ensure availability of supply leading cost and support global launches at scale. This translates directly into value as we will have greater resilience, flexibility of supply, improved margin profile over time. So this now brings us to BIO 100. The slide shows the overall size of the opportunity and how it breaks down into biosimilars compared to generics, including GLP-1s. As I said, whilst originators talk to the patent cliff, we see this as our golden decade. We see a huge step-up in the volume and value of LOEs, particularly in biosimilars, and whilst at the same time, generics continue to provide a broad resilient base, as I said, delivering sustainable cash, customer intimacy and overall generation of support. You'll hear more in detail about how we're positioning ourselves to ride this way from my colleagues. However, I first wanted to cover why now is the right time for Sandoz to introduce BIO 100 to you and provide you with more detail of the opportunity ahead. We're launching BIO 100 now because the window of opportunity is wide open. We believe it is our responsibility to capitalize on this opportunity in the interest of patients, shareholders and stakeholders worldwide. Firstly, there is a significant untapped value, over $300 billion of originator sales are not targeted by Sandoz today. This is clearly an actionable expansion opportunity. Secondly, the environment is becoming more supportive, regulatory streamlining, including the removal of Phase III requirements is accelerating our development time lines and lowering our cost per program. And thirdly, there is an evolving industry focus on biosimilar development, but this remains a complex base requiring capital, scale and technical expertise. The players that can do this are few and far between. And given the sheer scale of LOEs ahead, competitive intensity at an asset level is expected to moderate. To put all this together and the conclusion is clear. This is a unique alignment of market opportunity, favorable regulation and competitive dynamics. Sandoz is perfectly positioned to double down, scale faster and affirm leadership in biosimilars. Today, we have a pipeline that covers about 50% of the LOE value. By third 2035, we plan to have around 70 biosimilars in the market, covering around 80% of available opportunity. And by 2040, we intend to have more than 100 biosimilars, sustainably covering about 80% of the relevant valuable. We're building this engine to deliver this, significantly ramping up internal development from around two assets entering the pipeline per year to around seven by 2035 and up to 10 by 2040. That step-up is critical because it gives us greater control delivers higher margins over time and offers a more attractive returns. These targets are also supported us by being the partner of choice. A great recent example is our deal with Handers that can deliver an additional further 10 assets in key therapeutic areas. So in summary, BIO 100 is not simply an aspiration. It is a structured phased scaling plan with key milestones, delivering coverage and a disciplined buildup of capabilities. It positions Sandoz to translate the originator patent cliff into long-term shareholder and patient value. BIO 100 is the heart of our equity story. We are only a pure play -- we are the only pure play generics and affordable medicines company, offering a global scale. Number one globally with deeper market intimacy, a combination that is critical to drive adoption and win share consistently across regions. We pioneer that within the industry's leading pipeline, not just in size, in quality, but also the disciplined purpose same work protection and acceleration of our pipeline. And Rebecca in a while will take you through that. Importantly, we control more of the value chain through in-house development and a strong partnership model, we combine flexibility and capital efficiency, accelerating delivery while enhancing returns. Underpinning this will be a fully integrated scalable biosimilar manufacturing and supply network, giving us reliability, speed and flexibility and the cost advantages at scale. Add to that, our regulatory and IP expertise, we have a proven track record of successfully challenging weak or duplicative patents. For example, some 89% of cases we challenged with the European patent office are ultimately revoked or amended, enabling around 8 years earlier in terms of patient access. Now it clearly generates huge savings for health care systems and great opportunities for patients. But we also go beyond litigation by tackling complex patent structures such as patent thickets, whilst also engaging directly with policymakers to address the practices, including serial patent litigation. And finally, we have the financial strength to invest with a disciplined capital allocation and a clear commitment to sustainable profitable growth. So this is why we believe Sandoz is in a powerful position to win in biosimilars and that's the why. Now for the what. What will this look like in terms of net sales over the next decade and beyond? Our new midterm outlook from 2025 to 2030 is to accelerate net sales to grow at mid- to high single-digit percentages by 2030. And then to deliver more than GBP 22 billion of net sales by 2035. That is more than double our net sales of 2025, which were just over GBP 11 billion. At the same time, the sales mix will continue to improve. Biosimilars are expected to grow from around 30% of our sales today to around 55% of our sales by 2035, becoming the majority of Sandoz' revenues by then. The number of biosimilars in our portfolio is expected to increase from 13 today to around 30 by 2030 and to around 70 by 2035, providing clear visibility on how this growth is delivered. So this is not just a volume story. It's a deliberate shift towards larger, higher-quality, faster-growing businesses with BIO 100 acting as an engine to drive both scale and value over the next decade and beyond. And it would be remiss not to mention the meaningful opportunity in GLP-1s, an additional growth factor that is not part of the core BIO 100 trajectory. GLP-1s present a significant opportunity, and our approach is phased and disciplined. We will start with early market entries such as Canada and Brazil and other international markets, allowing us to build capabilities establish present and derisk execution. Through 2030, this phase is additive to our group growth. From 2031 to 2035 we plan to move into the major markets, the U.S. and Europe, were GRPs will become a material benefit to Sandoz of sales. Whilst it's too early to make sales forecasts, given the many uncertainties around how this very new, very different market would evolve, we see considerable potential sales upside here over that period. First, selecting the right molecules, i.e., the most competitive with semaglutide our anchor, liraglutide and tedaponite and so forth is critical. These medicines are where we expect we can compete effectively and create value. Secondly, ensuring continuous flexible and competitive supply, this is a key differentiator in this category. And thirdly, delivering timely launches with the right commercial model to capture share quickly and efficiency. GLP-1s provide a meaningful opportunity on top of the core BIO 100 strategy to further enhance our sales growth and drive incremental value. In summary, I want to bring all of this together so that our ambition becomes very clear. Our targets are explicit. Over the next few years, we will build our portfolio resulting in more than 100 biosimilars in 2040, giving us a commanding breadth and depth. This would be around 80% of the biosimilar LOE coverage opportunity by value, which we're systematically capturing the most attractive pools. Along the way, we have more than doubled our net sales by 2035 with GLP-1s as an additional potential source of growth. What underpins this is equally important. And you'll hear from Rebecca about how we're building structural advantages in the way that we accelerate our biosimilar pipeline. And from Armin, you'll hear how we continue to differentiate through development, manufacturing and supply chain capabilities. Later, you will hear from our three regional presidents about how we will leverage our world-class commercial engines translating launches into rapidly increasing market share and the patient access. And finally, you will hear from Remco on how we're stepping up value creation combining growth, margin expansion and other key financial deliverables to provide high-quality returns. This is a commitment with clear milestones, and I am incredibly proud of what we've achieved so far and amazingly excited about what we will deliver for patients, shareholders and stakeholders in the years to come. And with that, I hand over to Rebecca.
Rebecca Guntern
executiveThank you, Richard, and for the introduction, and good afternoon, everyone today in the room. It's a great pleasure to be here at the London Stock Exchange today. I'm Rebecca Guntern, Chief Commercial Officer at Sandoz. Since the spin-off, the last 3 years have been an exciting period of growth. Together with Richard and my colleagues, we've been working hard to deliver on our vision, to be the leading and most valued biosimilar and generic company. We are proud of what we have achieved so far, and we're even more excited about the future. In my 20 years with the company, I have never seen an opportunity as compelling as the one ahead of us. So today's presentation is a key opportunity to get you equally excited about our growth story and how we're going to drive value in the future. I will focus now on one of the most important drivers of our ambition: accelerating the leading Sandoz biosimilar pipeline. Let's dive right in. We are at the start of the largest opportunity in the history of biosimilars and generics. We are entering a uniquely attractive period driven by a record number and value of LOEs. As you can see on the left-hand side, the value of LOE opportunities across biosimilars and generics is expected to increase around 5x, reaching about $1 trillion by 2040. Sandoz is uniquely positioned to translate this opportunity into value. In generics, we are a leading company with global scale, and with over 300 assets in our pipeline, we are targeting a significant LOE opportunity of $450 billion. In biosimilars, our ambition is to extend our lead by addressing an LOE opportunity of $550 billion, supported by a pipeline of 39 assets that already by now leads the industry. So let's start with our generic business. Generics remain core to what we do. They offer scale and a strong platform for growth with attractive financial returns. Indeed, we are the only global pure-play biosimilar and generic company. The two businesses have strong synergies that are central to our competitive advantage. Our generic portfolio strategy is focused on areas where we can compete and win, particularly in oral solids and injectables. Oral solids account for 80% of the LOE ahead of us. That is further supporting our portfolio strategy. Our strong pipeline of more than 300 generics provides a steady flow of planned launches over the coming years, translating into an LOE coverage of 70%. This strategic focus is already translating into delivery with recent successful first-to-market launches, including nintedanib, dapaglifloxine and sitagliptin. Before I move to biosimilars, let me take a moment to share with you our GLP-1 ambition. GLP-1s represent an additional meaningful long-term growth opportunity for Sandoz. We're approaching it with the same pioneering mindset and discipline that has underpinned our leadership in biosimilars and generics. Our ambition is clear. We want to be a leading player in expanding access for GLP-1 treatment for more than 2 billion patients around the globe. Our initial focus is on semaglutide and on launches in selected early markets, starting with Brazil and Canada. This will be followed by launches in major markets in Europe and the U.S. From 2036, and beyond, we plan to continue strengthening our position through next-generation product launches. We have already made significant progress. We have received our first GLP-1 approval in Brazil, for the indication of type 2 diabetes in July this year. We're now aiming for a Q4 launch. Weight management is anticipated to follow. With only digit percentage of patients getting access to GLP-1 treatments across indications, Brazil offers substantial headroom for market expansion and a great opportunity to improve access tailored by market, complemented by in-house manufacturing capabilities, pen device expertise and fill-finish capacity. This approach is designed to provide scale in a market where demand, capacity and market access dynamics matter most. Finally, our preferred commercial partner position and patient-first approach set us up to have strong go-to-market strategies and local access pathway. Note that our opportunity is not simply to compete for share within today's market. Our opportunity is to play a leading role in expanding the overall size of the market and those total access to GLP-1 treatments over the next decade. Today, less than 2% to 3% of 2 billion patients are getting access to GLP-1 treatment. We estimate a market expansion in patient number in the range of 2 to 7x depending on market maturity and treatment affordability. The combination of market expansion, portfolio breadth and commercial strength is what gives us confidence to lever on our long-term GLP-1 ambition. Let me now turn to biosimilars, where I will spend most of my time today. Biosimilars are the single biggest opportunity and the major driver of our growth trajectory. This is a space we know exceptionally well. Sandoz is the pioneer of biosimilars, and 20 years on, we are the leading biosimilar company globally with 19% market share and a diversified portfolio of 13 in-market products. There are two key points I would like to highlight. First, as you can see on the left-hand side, we have proven time and again our ability to successfully launch products across regions. Today, eight of our 13 biosimilars are ranked either #1 or #2 globally, demonstrating the breadth and competitiveness of our portfolio. Second, we are leading at scale across their optic areas, market archetypes and regions. It shows that we can consistently bring a wide range of biosimilars to market and execute well. Our diversified portfolio reduces reliance on a single product and provides a balanced risk profile. In summary, we combine scale, proven execution and diversification. That is what underpins our leading global position today. As I always like to say, it is no coincidence that we are the global leader. We have worked diligently over decades to get there. However, we can never be complacent. As the global leader with an industry-leading pipeline, we must remain very ambitious and very focused to stay consistently ahead of the competition. This slide demonstrates our BIO 100 ambition, as already outlined by Richard to expand from 13 assets today to more than 100 assets by 2040, creating the broadest and most competitive biosimilar portfolio in the industry, targeting an LOE coverage of about 80%. We have a clear plan to get there. First, through disciplined and rigorous pipeline selection, focusing on the most attractive and commercially relevant assets. Second, by combining in-house development with strategic partnerships. This allows us to scale faster by managing risk and capital efficiently. And third, by leveraging our strong commercial platform. As I shared before, we have consistently demonstrated our ability to translate launches into leading market positions. In essence, BIO 100 is all about building on a success story with sustained global leadership in biosimilars, reinforced by a rapidly expanding pipeline. Let me talk briefly about another development that could significantly and materially benefit Sandoz. Recent moves towards regulatory streamlining worldwide are a major structural tailwind for biosimilars and a clear accelerator for our BIO 100 ambition over and above the LOE opportunity. What's changed is not the underlying science. It is the regulatory thinking. With Phase III efficacy trials no longer required, development time lines and development costs can be reduced substantially. This allows us to redeploy capital into additional assets, expand our pipeline faster and ultimately bring more biosimilars to more patients sooner. In other words, regulatory streamlining significantly increases both the speed and the scale of what we can achieve to BIO 100. Indeed, recent progress on streamlining will play a key role in addressing a critical remaining gap in the biosimilar landscape, the biosimilar void. To illustrate this, over the next few years, more than 60 biologics will lose exclusivity, many with no biosimilars yet in late-stage clinical development. This is a clear and significant opportunity where Sandoz can lead. As streamlining makes more molecules economically viable, you may see some smaller assets in our pipeline that will have the advantage of limited competition. Why does this matter? By targeting these gaps, we can accelerate access for patients, reduce health care costs and further strengthen our leadership in biosimilars. Our advantages in commercial scale, balance sheet strength and vertical integration in manufacturing compared very favorably to many competitors. The key to successfully realizing this opportunity is a rigorous pipeline selection framework. This slide shows how we bring discipline and scalability to process. First, we filter for attractive opportunities now focusing on products with over $0.5 billion in LOE sales. The fact of regulatory streamlining have reduced it to that level. Second, we refined based on operational feasibility and longevity assessment, including make versus buy decisions, ensuring we allocate capital efficiently and build the right balance of in-house and partnered assets. We also assess IP feasibility early on, providing visibility on the timing and likelihood of market entry and helping us to focus resources on opportunities with the clearest path to value creation. Third, we select the assets based on commercial value, risk and strategic fit ensuring a high-quality pipeline. In short, BIO 100 is not about pursuing every opportunity. It is about selecting the right assets to drive sustainable, high-quality growth. In the coming slides, I will show how this framework helps us to build our BIO 100 ambition. Let me now quantify the opportunity behind the ambition. This chart shows the biologic LOE landscape over time and the opportunity this creates for Sandoz. A quick word on how to read it. The dark blue segments represent the LOE value already covered by our current pipeline. While the lighter blue segments show the additional opportunity enabled by BIO 100 and the white portions represent LOE opportunities that exceed the BIO 100 opportunity. Directly below, you can see the corresponding number of assets in each period. Again, split between our current pipeline and the incremental BIO 100 opportunity. Let me highlight a few key messages. First, sheer scale of the opportunity. Our current pipeline already addresses an LOE opportunity of approximately $250 billion through 2040. BIO 100 expands that by $200 billion, those almost doubling the LOE value we will pursue. Second, BIO 100 adds more than 50 assets to our existing leading pipeline of 39 assets. Combined with the 13 biosimilars in market today, this creates a pathway to more than 100 biosimilars by 2040. Third, it materially increases the share of the biologic LOE opportunity we can address. Beyond 2035, as many of these biologics are still being developed, and the LOE landscape evolves, our ambition remains to steadily maintain coverage at around 80%. Ultimately, BIO 100 is much more than a pipeline expansion exercise. It gives us access to a deep an evolving pool of biologic opportunities and create sustainable long-term growth, expanding well beyond 2035. So this slide now provides a more qualitative look at how we designed the BIO 100 ambition. First, modalities, monoclonal antibodies will remain core, covering around 60% of the value, complemented by emerging technologies such as ADCs and other modalities. Second, therapeutic area. Most of the opportunities are in oncology and immunology. Together, these account for roughly 80% of the total and represent some of the largest and most attractive assets losing exclusivity. We can leverage our strong market presence and established commercial capabilities and infrastructure for future launches. And third, development type. BIO 100 will be driven primarily to in-house development, complemented by partnerships for acceleration. Let me share our approach in more detail. BIO 100 is explicitly designed to increase the in-house share over time, up to 70% are targeted to come from in-house development. This is our default approach because it delivers the best economics and allows us to fully leverage our end-to-end capabilities. We will continue to prioritize in-house until capacity is fully used. The remainder will be delivered through strategic core development partnerships and targeted BD&L. Development partnerships are critical to accelerate pipeline expansion in a capital-efficient way beyond internal capacity. Great examples are the recent strategic co-development agreements with Samsung and Hermes. These will be complemented by targeted in-licensing deals used to selectively capture near-term opportunities. So taking a step back, let me now help you to size the BIO 100 opportunity for Sandoz, starting with volume. There are 3 key drivers: First, market expansion. Biosimilars are not just substituting originators. They enable earlier treatment and broader patient access. While the range of market expansion outcome has been wide, we estimate an average expansion of around 10% to 20%. Second, biosimilar penetration. This is essentially the adoption rate, which rises significantly by market archetype and channels. Europe continues to lead U.S. driven by more favorable pricing, reimbursement and market regulations, including incentives. We expect an average biosimilar penetration rate of around 60% to 80%. Third, our market share with [indiscernible] This is where execution really matters. Share is driven by the level of competition and by the launch timing, but critically also by our commercial scale and capabilities. Based on our past performance, we would expect an average share of around 20% to 30%. Then on price, the key factor is the discount to the originator. We assume peak sales typically occur several years aftermarket formation, and pricing at that point reflects the net discount in a competitive biosimilar market. We assume a price discount of at least 65%. Overall, this would translate to an approximate 5% share of the total value for Sandoz. So when we put this all together, the BIO 100 opportunity is not just the function of originator size. It is the result of access-driven market expansion, adoption dynamics execution on market share targets and disciplined pricing. Let me now illustrate how Sandoz wins impact is using the Hyrimoz launch in Europe as a case study. Hyrimoz targets Humira. Historically the largest biologic globally with close to $18 billion in peak sales in a market characterized by intense competition. What you see on the left side is the critical dynamic since the introduction of biosimilars in 2018, driven by broader and earlier patient access the adalimumab market in Europe expanded by roughly 90% in volume. Biosimilar penetration increased consistently, reaching around 80% by 2025, mainly driven by fast adoption in tender markets, but also share of voice markets like Germany. Sandoz captured meaningful sustainable share of around 20% despite increasing competition. This demonstrates two key capabilities: first, our ability to win share in a highly competitive market, where success is determined by scale, access and commercial strength. Second, our strength in sustaining share over time, even as more competitors are entering. And we're seeing a similar playbook developing in the U.S. where we have now reached #2 position in adalimumab. So how will we ramp up BIO 100? In the near term, our focus is on execution. We will ramp up development and manufacturing capabilities as well as strategic partnerships, which will build the foundation to reach around 30 assets by 2030. To put this into perspective, since the launch of our first biosimilar in 2006, we have launched 13 products. Over the next 5 years, we plan to launch 17 and meaning we would more than double our in-market portfolio by 2030. By 2035, we plan to further expand our global leadership position by reaching our goal of 70 end market products. Beyond 2035, the focus shifts to sustaining and expanding our leadership further. We expect to reach 100 launches by 2040 with even more expansion into emerging technologies. Armin will talk more about how we will get there and the preconditions for success. So let me close by bringing it all together. We will remain relentless in our focus on what matters most: delivering excellence for patients and expanding access to high-quality medicines around the world. We have a clear road map establishing Sandoz as a sustainable long-term leader by 2035. We're building our next chapter of leadership in biosimilars with a pipeline designed to cover around 80% of LOE by value and more than 100 biosimilars in our portfolio by 2040. But perhaps most importantly, we have the capabilities, the commercial platform and the execution track record to turn this ambition into reality. Sandoz stands alone as the only global integrated pure-play company across biosimilars and generics. That's why we are so strongly positioned to shape the next era of affordable medicines, delivering sustainable growth, strengthening our leadership for years to come and continuing to pioneer access for patients more than ever before. And with that, I would like to hand over to my colleague, Armin.
Armin Metzger
executiveThanks, Rebecca, and welcome, everyone. My name is Armin Metzger, and I'm responsible for our end-to-end biosimilar development and manufacturing, all the way from early development through to manufacturing and supply. To put it simply, my team takes our pipeline and develops and manufactures those assets. most delight to join Sandoz around 6 months ago. It's a true honor to hold this key position in the company that is doing more than any other to redefine affordable health care. And it's a pleasure to be with you all day to talk about our plans to make this all happen. I would like to focus now on how we are going to translate the by 100 ambition into reality. Specifically, I want to explain why our biosimilar development, manufacturing and supply chain platform can be unique, competitive advantage. In biosimilars, success is not just about the pipeline. It's about execution at scale, supply reliability and cost leadership. Actually, 6 months ago, like you, I looked at Sunday investment decisions on the outside, and I was really impressed how the foundation was set to achieve those objectives. At the core of the model, we are creating a full vertical integration. As our in-house network comes online, we are going to be in full control of the end-to-end value chain from development to drug substance manufacturing to fill and finish. Our setup is flexible with significant capacity and building opportunities for further expansion and the network spanning Slovenia, France and Germany. This will be a true European geopolitical stronghold producing reliably and at competitive cost. I'm looking forward to a site visit in November and we will show many of you our new fit for purpose biosimilar development and manufacturing facilities in Slovenia. This, along with our acquired site in France, provides an excellent platform across both had batch and continuous manufacturing. Of course, we can't and we won't do everything ourselves. We will continue to work with third parties where appropriate. For instance, our recent agreement with Helios to commercialize up to 10 additional biosimilars. As Rebecca already said, our in-house capabilities will be complemented by strategic partnering to ensure that we optimize our overall use of resources in light of rapidly expanding demand. The map here shows our integrated European biosimilar hub. Some are still under construction. But I will take you through the time lines in a moment. Once completed, it's going to be a fully integrated along the value chain, geopolitically resilient, anchored in Europe and designed from the ground up to operate at significant scale. Importantly, it will allow us to serve all major global markets and launch many new medicines cost effectively. Let's look in more detail at the fully integrated end-to-end biosimilar engine we are building and how that will support a distinct sustainable advantage. So how we do turn our biosimilar development capabilities into a true competitive edge to ensure success of BIO 100. As a disclaimer at this point, I'm focusing today on our development, manufacturing control set up. But of course, we will continue to benefit from our strong clinical and regulatory functions, which are equally essential for our biosimilar business. Back to the slide. Along the top row, you can see our key development locations across Europe, each with a clearly defined role. Ljubljana is our core hub for CMC development particularly for fed batch development. There's a huge step-up in our biosimilar development capabilities, covering drug substance, drug product and analytics. Toulouse complement this and complement is a very important word here, complement with CMC development for continuous manufacturing. Holzkirchen, Germany focusing on analytical characterization, clinical bioanalytics and bio assay development. And Cambridge adds device development capabilities. Note that Dave, our Head of Device Development Cambridge is here with us today. As I mentioned earlier, and Rebecca also stressed it. All this will be complemented by our strategic partnerships with, for example, Samsung Bioepis, providing additional external development capabilities and capacity. Overall, the in-house share is increasing over time. This integrated and strategic lip forward in the scale of and access to development capability is one key reason while I'm confident in our ability to deliver BIO 100. That development engine that seamlessly connects into our industrial scale supply network also benefits from geographic proximity. Turning to the manufacturing side. In Lendava, we will produce soon drug substance at large scale using stainless steel fed-batch technology. In Toulouse, we will operate continuous manufacturing technology. Along with them, as announced earlier today, will give us disposable fed batch capacity for our low to medium volume products. And for fill and finish, Ljubljana covers those while our new site in Brnik completes the value chain with syringes, cartridges and auto-injectors. By the way, all this could be eventually also used for GLP-1 fill and finish operations. This is not just a network of individual sites and technologies. It's a fully coordinated end-to-end ecosystem that for us is the ideal platform to deliver. Let me go into a bit more detail on the newest part of the network, the new kid on the block. As we announced this morning in Ljubljana, next our development center, we are building an 8,000-liter disposable set batch drug at facility, around $300 million of investment due to the operational from 2029. This will do two things. It expands clinical and commercial production capacity for our low to medium volume drug substance products, and it puts drug substance production right next to the development side, taking real-time out of tech transfers. Note, this is advanced disposal feedback technology to Ljubljana for us an important bridge technology for biosimilar platform, complementing our in-house high-volume platform in Landover and the continuous capabilities we have in to lose for low to medium volume production. A key point is that our hub is already built, being built and funded. In Ljubljana, our new state-of-the-art, digitally integrated by a similar development center was recently opened. Alongside it, we are building our disposal fed batch, drug facility, while next to the park in Brink, we will finish construction of the aseptic side in 2028. In Lendava 120,000 liter stainless steel drug substance center completes construction this year and will start validation for commercial production in 2027. In Toulouse, the development center is already up and running with continuous manufacturing on the same timetable. All the sites will use state-of-the-art, digitally integrated systems and will follow, of course, the highest quality standards. So timing works for us. We're already beginning to feel the positive effects of regulatory streamlining on our biosimilar development programs and major LV opportunities are kicking in. Volumes will ramp up and the capacity for growth will exist with our network, significantly reducing execution risk and supporting delivery of our programs. Bring development and supply in-house is one of the most important levers for value creation in our model. Today, as is the case for many other industry players, a large part of biosimilar development and manufacturing is externally sourced. What we are doing in Sandoz is fundamentally changing that with a clear ambition to move between 50% and 70% in-house development and around 60% in manufacturing. The real benefit of our financials will be filled in the 2030s and is aligned with our new midterm outlook that Remco will take you through later. By creating and expanding this in-house capabilities and development, we will decrease development costs and provide greater production flexibility, allowing us to prioritize, accelerate or adopt programs based on market dynamics. In the near term, external partners will continue to help us bridge capacity and share investment. But over time, we will shift towards owning the critical capabilities, which we significantly improved returns. On the supply network side, the impact will be even more direct, lower product costs, through in-house capabilities, higher supply flexibility, which is critical and tender-driven markets and ultimately, greater competitiveness in pricing and access. At the same time, we retain flexibility team to access adjacent technologies through selective partnerships. So when you bring both sides together, this is a fully integrated operating model. This shift to in-house is structurally margin attractive, will enable us to grow faster compete more effectively and expand margins over time. All of this will translate into clear financial outcomes over time. We expect near-term benefits from procurement as well as sourcing and productivity improvements across development and our supply network. From 2030, the impact becomes more structural for in-sourcing, vertical integration and scale. So the internalization is not only about control. It's also a key lever for lowering costs, improving supply resilience and strengthening our long-term economics. Diving deeper into manufacturing. We are going to go from making none of our biosimilars volume, which was the post-spin of status quo to making the majority. Along with significant scale of the facilities, A key differentiator is our three technology drug substance platform. Disposed of the fed batch at 2,000 to 4,000 liters in Ljubljana, gives us the flexibility to run moderate volume products and clinical batches on the same platform. Stainless steel fed bad at 15,000 liter in Lendava will deliver significant reliable output for our highest volume product at low cost per gram. Continuous manufacturing in Toulouse will provide higher yields for appropriate molecules with their technology at limited cost and with more output per unit of bioreactor volume. By leveraging this complementary set of technologies across our network, we can allocate products to the most appropriate platform and optimize manufacturing performance. This approach will enhance operational flexibility allow us to respond efficiently to evolving demand profiles and support cost competitiveness. So what does all this mean for our cost base? The network I've just described doesn't only give us more control. It changes the economics of biosimilar supply as the effect builds over time. Three things will drive it. First, top line growth. As BIO 100 volumes come through, we will absorb more output across the same asset base, scale and the flexibility of products between our three drug technologies will keep as utilization high as portfolio expense. That flows straight through to unit cost. Second, continued discipline on working capital. We will keep inventory and planning tight across the network, so that growing volumes do not tie up more cash than they need to. And third, productivity, process optimization, better yields and procurement excellence across a much larger in-house space. This will be steady compounding improvement rather than one-off steps. Put those together, and the application is clear. Significant unit cost reduction from 2030 and a structurally lower cost of cost of goods sold to the decade that follows. The step change will come as the network reaches scale. Remco will take you through what means this for our margins later. We've also put in place a range of extensive capabilities to support delivery of BIO 100. We will drive cost competitiveness from early development and accelerate our speed to market through in-house efficiencies, while increasing our flexibility via selective partnering. On the right, you will see that we are going to combine supply reliability, specialized know-how and disciplined cost control within a scalable network. Together, this capability will create an end-to-end model from cell line development to commercialization, presiding Sandoz as a leading biosimilar company with the ability to scale based on substantial and high diversity development and manufacturing capacity. So to conclude, the foundation of our future success is already largely in place. We have actively invested to support growth with a fully integrated European network already increasingly in place. This is about ensuring scale, reliability and efficiency across our key markets. By 2030, we will move into the next phase, optimizing how we develop and manufacture biosimilar medicine. Here, the focus will be on achieving the right balance between internal and external development and manufacturing. By combining in-house capabilities with targeted external partnerships, we can accelerate speed to market while maintaining disciplined source resource allocation. By 2035, the model will have evolved further with greater in-house strength including leading manufacturing capacity capabilities that deliver significant benefits. At this stage, we will have leveraged our internal capabilities to accelerate growth turning our integrated platform into a sustainable competitive advantage. The 2030 will be the decade when the full benefit of the in-house network come through with greater control, faster execution and stronger value creation. In summary, this is a multistage process that starts with building the foundation, progresses to optimizing the model and concludes by fully realizing the value of an integrated self-reinforcing network. And with that, thank you for your attention, and I would like to invite Richard, Rebecca and Craig back on stage, and we will pause here so that people in the room and through the webcast can ask questions about what you have heard so far before we go to a short break. Thank you.
Craig Marks
executiveThanks, Armin. So bearing in mind, for those online, you can't see, but it's is more people than a U2 concert here. So we really should have charged and we have over 1,000 people online right now. So we're expecting quite a few questions. This is the shorter of the two Q&A sessions. But feel free to put your hands up. What I would say for those in the room, if you can make yourself very visible because the lights are really bright, so just so we can see you. If you let us know your name, where you're from that would be great. So as I said, we'll take questions for the webcast and moderate through the iPad. But maybe, I think, James, you had your hand up, James.
James Vane-Tempest
analystIt's James Van-Tempest from Jefferies. Two, if I can, please, just on the growth drivers. Firstly, how much of the value growth from biosimilars is from the larger products to give us a sense of product concentration versus the smaller opportunities with the removal of the requirement for Phase III? And then my second question is if you have an aspiration to double the business, excluding GLP-1s by 2035, how much of that can be underwritten from current business and pipeline versus expected new pipeline and business development in the outer years give a sense in terms of to bridge what can be delivered from the business today?
Richard Saynor
executiveThank you so much, James. Perhaps if I take the first question for be, do you want to have a stab at the second -- on the growth drivers. So look, so growth is in a sense, it's more effective for me as a function of competition. If you look at a product like denosumab, I think we have 7 competitors in the U.S. And clearly, it's been a very attractive growth driver. We've taken a leadership position both in Europe and in the U.S. I think a smaller asset, and it goes back in Slide 33 in Rebecca's presentation gets into the slightly counterintuitive view. A question I get a lot is, are we going to get more competition? I think perversely, we see less competition, particularly in the small and midsized assets. You see this describing IQ describe it as a biosimilar void. So I think you see a materially lower number of competitors. So actually, I think over time, there's a significant value opportunity from some of the more modest assets. And I guess the best proof point is Omnitrope. We launched it 20 years ago. It's still one of our largest products and the one thing I guarantee, it's never going to go off patent. So it continues to drive value. So I think it's going to be a combination very hard to predict. But I do think, perversely, we're seeing this reduction in competitive intensity rather than increasing. Rebecca?
Rebecca Guntern
executiveYes. So thank you, James, for the question. I think 1 big strength of the BIO 100 ambition, which we just presented is actually diversification of the pipeline across the operating areas, across different technologies and also size, right, different sizes of the products. And I think this is keeping us a great risk profile, which is very, very balanced and really reduces the, I would say, reliability on dependency on a single asset or a single market. So actually, this is a core strength. And of course, why the larger products will contribute a large portion of growth we actually benefit and will benefit also from the smaller assets, which Richard just explained because we expect limited competition. Cetuximab, which we just signed with is a fantastic example, right? It's a midsized asset. And actually, what we're seeing currently is there's very limited competition. So we do believe we're going to create great access in this product, but also long-term value.
Richard Saynor
executiveThere's also still some lungs to your point, the existing or if you look at [indiscernible it's one of my big frustrations. We launched in 2017 in Europe. We still haven't launched it in the U.S. because the U.S. courts perceived that it had a patent expiry in 2030. That is still an asset that's going to create value for us as a company. It just happens to be 10 years later, more than 10 years later than we first launched it in Europe. And similarly, I could say exactly the same with [indiscernible] So I think there's still momentum on growth. And then you'll hear from Peter later on a lot of the portfolio that we're still currently launching in Europe, we're still yet to launch in international markets. And on top of that, I think there's a formula, I think this is Page 35 on Rebecca's slide that actually, we try to think about how we could explain to everybody how to model the market expansion element and how that value creates. And I think the gain our existing portfolio has a significant opportunity to do that. So there's still a lot of land left in there -- a lot of legs left in the portfolio that we have existing as well.
James Gordon
analystJames Gordon from Barclays. I know we haven't heard from Remco yet, so I won't ask on margins yet, but I will have a question there. So a couple of questions on biosimilars. One was, can you talk about the flex on the mid- to high single-digit sales outlook, it's quite a wide range. I assume the flex really is in biosimilars. And Slide 38 was useful in terms of talking about some of the factors to get to our peak. But is the key flex from really about the competitive question, and it might be that there's not as much competition in some of the smaller biosimilars. But if the outlook is as strong as you described, it sounds like, why wouldn't lots of companies want to go for this? Is that the key flex whether we get lots of new players coming in maybe from Asia trying to go after some of the western markets. So what are you assuming about more competitive intensity when you build this out? That would be the first question, please. The other two are quicker, which would be when you talk about the peak, how quickly do you think that fades away because you can get some really big numbers, but did they stay there for a long time? Or do you think they erode from that peak quite quickly? And then finally would be -- so it sounds like a sustained double-digit biosimilar growth CAGR all the way out to 2030? But how linear is that? Could there be a big slowdown in that in '27 and '28 and then it gets really exciting? Or do you think -- could you do double-digit biosimilar growth for the next couple of years as well?
Richard Saynor
executiveThree great questions. If I start with the sustained growth, I think, look, if you look at the last 3 years, we've consistently delivered sustainable growth out of those biosimilars. And they're still launch -- I mean, we'll look to launch aflibercept later in the year in the U.S. So there's still -- and then clearly, I mean, I'll get Rebecca to comment on some of the launches that bridge to 2030. So I think there's some very nice momentum in the existing portfolio and clearly some of those deals. So I don't -- I'm not too concerned. I think there's some very nice momentum. And in many ways, part of the reason we're here is that we committed to delivering 30% of our net sales from biosimilar by 2028. Clearly, we've done that nearly 3 years early. So the momentum and the access. And also, I think the bit we consistently underestimate is the expansion of the market as we serve more patients. Biosimilar effect, honestly, I don't see it so much. It goes back to the Slide 33. I think the IQVIA this biosimilar void, this $500 million to $1 billion assets, do I expect to see 10 competitors? No. Do I expect to see one or two? Yes, maybe. Are we good at competing, I think, absolutely. I think we have a strong platform in Europe. You'll hear from Christophe and Keren and Peter in a little while. I think we've built a strong commercial moat. And also Sandoz is unique. A lot of our competition maybe are in-licensing a portfolio. They're losing the flexibility that Armin heard. We have a great front engine. We have a great IP capability. We're building the manufacturing. We have partners that want to work with it. We're pretty unique. And so competition, we're used to it, the way that works, actually, I think I'll see less going to my other one. Do you want to talk about peak, Rebecca?
Rebecca Guntern
executiveYes. Maybe just quickly on '27 because you asked to comment on the '27, I think an important driver of our biosimilar growth is actually also that you have, of course, the in-market portfolio, and we have proven this in the past, right? If you look at the European performance, even in years, and there was 2, 3 years without launch, we continuously to grow the business based on market expansion based on the formula we presented because you see this broader and early access for patients, which is then driving volume, which is driving at the end of your top line. And '27, '28, don't forget, we just had recent launches with tanezumab in Europe and the U.S. We're still going to see the aflibercept launch in Q4 this year happening in the U.S. So we will have benefit of exactly those launches also translating into '27 and even, I would say, '28 in the case of Europe and beyond. So there is growth momentum. There are big LOEs to come. We will launch insulins in Europe with Christophe, we're going to launch potential pertuzumab in those time frame. So there's a couple of really exciting opportunities for us to grow the business and drive patient access '27, '28. And then, of course, post '28 it's an exciting period to step in with the big oncology launches coming to the plate. And I think we have a lot of opportunities to build on our existing strong commercial platform to drive incremental growth. Then on the peak sales, I think it depends. What we try to do with this value creation slide, is to help you and hope you found it useful. The way we think about value creation, right? And you saw three metrics, which are on volume, which is this market expansion the penetration, the adoption rate and then the market share. And then, of course, you have at the end, the price. So peak side depending on the market archetype, the product, the therapeutic area. If you take Omnitrope, I think we have not yet seen peak, right, 20 years in a row because we're still growing. We're still expanding the market and driving access. While, of course, in other oncology assets, you may see these peak sales 5 to 7 years post in-market formation, so that's why we are giving ranges in this value creation because there is not the one-size-fit-all formula depending on the asset.
Craig Marks
executiveYes. I'm just going to take one from the webcast, if that's okay. This is Joris from Octavian. Hi Joris, good to hear from you. I've touched on these, so whether you have any other comments. So for the 26 to 30 period, you have 10 biosimilars in development to target LOE opportunities with a further four planned under the BIO 100 ambition. Can you provide more detail on when exactly you expect to launch these next biosimilars?
Richard Saynor
executiveAgain, there's a slide in the backup that highlights -- and again, it's the LOE, so don't get misled. And that's -- I mean, I know we laugh a little bit about aflibercept, there's an 11-year gap between first launch and last launch. So it's not as though we launch everything on 1 day all over the world. And that's just the nature of the business. So the slide shows, I guess, were the first market -- regulated market formation, the first large market. But clearly, there's value creation for years afterwards. And I think that gets underappreciated a little bit. So there is a very good slide. We've tried to disclose as much as we can without me getting into too much trouble in terms of my colleagues are disclosing that, making our competitors life any easier, but there should be enough detail in the backup there for you.
Craig Marks
executiveOkay. It's difficult to see you guys, but we'll go to...
Unknown Analyst
analystJust a question on CapEx. Since the spin-off plan, the CapEx plan, I think, for the period, I think it was $23 billion, $28 billion, it was $23 billion. there was a ramp up of $1 more billion that's been announced since then there was the Evotec deal and to the recent announcement for the manufacturing facility in Slovenia. So just with this sort of additional CapEx that you've announced over the period, how much of the Bio 100 is covered with that capacity? And if you could comment in general on the capital intensity you're expecting for the business as you want to expand the number of biosimilar market to 100 versus next. Yes, that's next to 2030.
Richard Saynor
executiveThank you so much. I mean I'll ask Remco to comment briefly, but effectively, you've just summarized most of his presentation. So perhaps if I don't know if you want to add anything, Remco, other than I'd rather let Remco perhaps cover quite a lot of that in detail and if it's not adequately covered, perhaps then we could come back to you right at the beginning for the next session. Is that okay, Craig?
Craig Marks
executiveWe have some more of the question directly to your left.
Florent Cespedes
analystGood afternoon. Florent Cespedes from BHF. Two quick questions. First, regarding the U.S. market. So you are very strong in Europe. You have great ambitions. So could you maybe share with us how you will increase your presence in the U.S. market, which is very relevant for biosimilars? Second question, a quick one on GLP ones. Are you planning to also develop the oral formulation of semaglutide or pillars well when it will be off patent or will you remain focused on the injectable formulations?
Richard Saynor
executiveFirst of all, thank you so much for your questions. Again, I'll let Keren -- I don't want to steal Keren's presentation again. I think exactly to your point. I mean I'm very delighted how the U.S. business is performing. I mean you're seeing great execution, but I really don't want to steal Keren's thunder, so I'll let her onto that. GLP, we're a generic and biosimilar company in a sense, of course. Our job is to develop copies. We're pretty agnostic. As you've seen in our filing, I think our portfolio of GLPs is very broad, both oral and injectable. We would look to be at market formation for both injectables and orals for Europe. Obviously, we just filed -- had a fast file accepted in the U.S. for tirzepatide. This is the joy in a sense, I'm a relatively agnostic on products. molecule. Our job is to deliver the broadest possible portfolio to patients.
Rebecca Guntern
executiveYes, the strategy is hybrid, right? So we have in-house development, and we will launch our own semaglutide post 2030 which we are also investing now very targeted manufacturing capacities and fill and finish. As Armin has then we can leverage Brnik. And then we have a huge portfolio of assets, which we're also going to look into in-house development beyond semaglaidetercipatide where we got the approval from FDA. And fundamentally, I think it's bringing those assets to patients. And of course, we're going to target those for formulations and injectables to really reflect the customer needs, and I would say, the evolving markets you currently see.
Craig Marks
executiveRight. Can we take 1 from the webcast. So this is Nicolas from Kepler. Good to hear from you, Nicholas. The second question on profitability, may well suggest that, that's covered by Remco in the second half of the session. So on the first is around IP. So when it comes to patent litigation, I believe you've mentioned you had an 89% win rate in Europe. Any color on what the rate would be in the U.S. and the rate in the larger assets, so $10 billion-plus peak sales as we'd expect much higher patent tickets on the massive LOE coming early next decade.
Richard Saynor
executiveIt's a great question. I'm looking at my general counsel. I don't know the specific actually on the percent in the U.S., I think we certainly, we win more than we lose, which is good. Ingrid, I don't know if you want to comment?
Unknown Executive
executiveYes. So I think it's -- we need to differentiate because the system is very different between the U.S. and Europe. So comparing the numbers would not give a clear answer. What we can say is that our litigation track record on both sides in the U.S. and Europe is very strong. We are very committed to continue doing that. And then in addition, as I heard patent ticketer litigation, I think we are really the thought leader in the industry when it comes to challenging these patent tactics and these what we see as abusive behavior. And we will continue doing that because we are fully committed to also be the voice for patients and accelerate the excess for them.
Simon Baker
analystSimon Baker from Rothschild. Two quick ones for me, please. Just picking up on something you said, Rebecca, your -- your slide on thinking about the value generation was very comprehensive. The one bit that was missing was something you just mentioned, which was the time to peak is about 5 to 7 years. I just wonder if you could give us any idea of how that varies by region and by therapeutic area was 5 to 7 a reasonable estimate for the piece the whole piece. And then on the GLP-1 opportunity, I believe at the moment, all of the API manufacturing is outside your network presumably as that opportunity develops, you'll start to bring that in-house. What's the capacity at the moment? Because if this -- if this market really does become 2x to 7x peak or [ 2,000 ] volumes at peak, it could be colossal. So I wonder if you could sort of talk us through how big this could be and how much of that scale is an advantage of going to Sandoz given the difficulty of replicating manufacturing at that sort of volume.
Richard Saynor
executiveI'll take the GLP and then Rebecca, I'll pass to you on -- we're not an API manufacturer. I mean we want to be clearly vertically integrated in [indiscernible], we have no intention of being vertically integrated in peptide. There is plenty of peptide availability in terms of a number of suppliers that we work with. Where I do think we have a unique position is really certainly in injectable still finished. So we have numerous partners that we're working with. And as well as Armin described, we're building injectable capacity in Brnik, which, again, certainly as we look to launch in some of the regulated markets, we would leverage in combination with a number of strategic partners. But to be absolutely clear, I don't see a point where we would want to get into industrial manufacturer of GLP-1 peptides. There are plenty of suppliers out there that we can work with, who are investing in building capacity. Do you want to pick on peak sales?
Rebecca Guntern
executiveSo on the peak sales, I said, it depends, right, on product and therapeutic areas. It's not every time, 5 to 7 times. In Europe, of course, we benefit really from a very favorable biosimilar adoption framework. So in a sense, what you would see, adalimumab in Europe, we launched in 2018 that the product is still growing, meaning it's more than 5 to 7 years post LOE that the product is still growing. And I think we see the same as I was mentioning also in bacteria. So it really depends. And the most important part of the entire value creation, if you think about why we are here is the market expansion. And this is really the broad range where you see up to 100%. And I brought the example of adalimumab, which was doubling actually access for patients. We do see the same, by the way, in pegfilgrastim, infliximab, where we're really driving and doubling market expansion over time. So which means in Europe, this peak sales could go endlessly, periodically, right? I mean there is not in that end. And also in the U.S., I mean, we saw some great examples where we really see continuous adoption rate because it takes a bit more time, right? It's more gradual than what you would see in Europe with the benefit that also here, especially in the medical benefit part that is really driving continuously access, but they have different dynamics. And then last but not least, don't forget the international markets, for us, a huge opportunity to drive access and expand the market. In many cases, in markets we're seeing patients not even have access to biologic treatments as of today. So another huge opportunity for us to drive access. And there, we have a very customized approach market by market and depending on the current maturity.
Richard Saynor
executiveBut I think as you land -- I mean, again, back to peak sales are going to be 12 years after we first launched it. I mean how do -- and clearly, you had this very -- and as you launch potentially 10 products a year, the momentum that builds in terms of cash generation, value generation, the ability to accelerate is, I think, really a huge opportunity for us over the next decade.
Craig Marks
executiveOkay. We'll take the last one before the break. Harry?
Harry Thomas Sephton
analystIt's Harry Sephton from RBC. So my first question is on your top-down view of the biosimilars market and specifically that price discount, which you set at about 65%. Now much of your pipeline is in very high priced oncology products, which are much more expensive than some of the originators of your current biosimilar portfolio. So my question is whether that price discount that we've seen historically with some of these products actually holds going forward when you see a product like KEYTRUDA which in the U.S. is $200,000 a year to treat, whether we still see that level of price decline or actually is meaningfully higher, especially as some of the development costs have come down. And then my second question is on the Helio still. So one interesting portion of that was the Halozyme assets. Now your portfolio has a number of subcutaneous products. My question is whether you have good line of sight that the regulatory framework actually allows to use that endless enzyme for your subcutaneous products and whether that could be a meaningful competitive advantage.
Richard Saynor
executiveI think probably the second part, you probably answered your own question. I mean in a sense -- maybe I get Armin to comment on that. And the first, in a sense, we don't price our products from cost. It's basically is a function of competition. In the case of pembro, if there's a lot of competitors in a sense, the market will set the price based on the level of competition. I mean, the 65% in a sense is a slightly historical view. I mean, clearly, if there's lower levels of competition, we price it to be attractive to drive access, but also sustainable to us as a business. So in a sense, it's a guide. It can't be a rule, but I think historically, it's around about that sort of figure. Equally, if we launch a lot more smaller assets with lower levels of competition, then clearly, we wouldn't expect to give away on a drug like pembro. I think you probably give more because you're going to see more competition. Oncology assets tend to be more tender-driven through hospital-based poo-procurement. Retail assets tend to be more fragmented, but it's a guide. I mean really it's more, I guess, a function of competition. I don't know -- Armin?
Armin Metzger
executiveSure. Thanks for the question. Yes, indeed, we have a couple of programs in the pipeline. And of course, enzyme is very important. But I think it's a question a lot of different countries, regulatory processes, how much you can use certain enzymes from different manufacturers. Of course, the bid is in our program on. Therefore, that's value to our pipeline, right? So definitely.
Rebecca Guntern
executiveOn the pricing, I think one other part, which is important is even in the most competitive markets and if you take adalimumab, it's at the end, still not on price only, right? I mean we're winning in this highly competitive market, not only because of pricing, but because of portfolio breadth, trust a brand access, I think, contracting tender capabilities when it comes to Europe and tender market. So this is how we have built a BIO 100 assumption, right? I mean we did a level asset-by-asset level analysis to exactly what Richard said. What is the future competition looking like? So we built it really on a very detailed plant and also taking into account what we have seen on the recent, I would say, the highly competitive launches. So I feel really confident on how we have built the BIO 100 ambition. And again, price is one of the criteria to win.
Richard Saynor
executiveOkay. Thank you. So just to add, we have some colleagues outside Dave and James from the Cambridge site if you want to have a look at some of our devices, including some of the potential GLP-1 devices, heaven forbid, are outside. So when you're grabbing a cup of tea I know they'd be delighted to show you some of our device technology. Just the device, obviously, it's not free GLP-1s. A lot of chocolates, which is bar...
Craig Marks
executiveJust so you know, Richard just massively stole my thunder because I was going to say exactly that. So we are going to come back and restart at 25 past. Thank you for your time and thank you for listening. Thanks. [Break]
Craig Marks
executiveSo welcome back, everyone. I hope you had a good break. And before we start, I'd like to play a second video that reinforces once again the critical importance of biosimilar access. [Presentation]
Richard Saynor
executivePowerful work from Gustavo. Access for me doesn't mean when we celebrate the first person who gets this life-changing drug, we celebrate when the last person gets this drug. In other words, everybody who needs it has access. So now let's talk about what we -- at Sandoz will do to get these critical medicines to the people who need them region by region. You'll see from the following three presentations that we have a very well diversified and balanced geographic footprint. Europe, our champion have represented the majority of our sales last year, followed by international and then North America, both roughly similar in size. In biosimilar alone, we generated over $3 billion in net sales last year, now about 1/3 of our total net sales. All regions are expected to continue to see strong biosimilar growth over the next decade. In Europe, our scale and deep local presence gives us a strong market penetration rate and high conversion rates, supporting expected market growth rates of around 15% in biosimilars and 5% in generics. In our international markets, we benefited from disciplined market and pipeline execution, continuously expanding patient access. Here, we anticipate market growth rates of 19% in biosimilars and 4% in generics. And in North America, our broad portfolio and our commercial strength positions us as a partner of choice, particularly with strong market growth prospects of 23% in biosimilars and 11% in generics. You'll now hear more details from our three regional presidents on how we committed to deliver on the BIO 100 ambition representing Europe will be Christophe Delenta; representing international will be Peter Steneico, and for North America, you'll hear from Keren Haruvi. Finally, Remco will take you through how BIO 100 will translate into attractive and sustainable value creation. I will close the presentation and then we'll move on to the final Q&A, finishing around 5:00, ready for drinks outside. Okay. So Christophe, over to you.
Christophe Delenta
executiveThank you, Richard, and good afternoon, everyone. It's really my pleasure to be here with you today. My name is Christophe Delenta. I'm the President of Sandoz Europe. And over the next 10 to 15 minutes, I'd like to walk you through our European business, what makes it special and how we will contribute to realizing BIO 100. As you have heard previously from Richard, Europe plays a central role within Sandoz as we represent over half of Sandoz net sales. It is a stable foundation from which we operate in the rest of the world. You can see that in our numbers, we have delivered 21 consecutive quarters of growth in Europe, consistently supporting Sandoz's overall performance. And that is all thanks to our team-wide commitment to delivering on purpose with strong execution supported by distinctive market expertise. While biosimilars are the key growth engine, our generic business remains the backbone of our European platform, providing scale, resilience, trusted customer relationships and broad patient access. So today, I'd like to begin by sharing how region Europe has built a world-class commercial engine, leveraging scale and portfolio strength to expand access and capture new opportunities across the markets. So let me start with the big picture. We are Europe's leading biosimilar engineering company with 11% market share, roughly twice the size of our nearest competitor, and we continue to expand that lead year-on-year. From an external market perspective, we operate in a large, attractive and growing sector. The European biosimilar market alone is worth USD 18 billion in 2025, and is set to grow by 15% per year over the next decade, creating a significant and sustained opportunity for us. What differentiates Sandoz Europe is the strength of our commercial platform across 40 countries and the associated expertise that allows us to succeed equally across all the three market archetypes so tenders, share of voice and substitution. This footprint gives us critical reach and proximity to local customers and patients. Indeed, we are not only the overall regional market leader. We hold leading positions in almost all individual European markets. We have strong go-to-market capabilities, leading in first-to-market execution with strong market access and commercialization excellence. These capabilities allow us to consistently capture new opportunities that translate into purpose-driven impact at scale. Last year, we delivered 455 million treatments to patients across Europe. That's the equivalent to about one treatment for everybody living in the 27 countries of the European Union because that is what we really mean when we talk about world-class commercial engine, that we combine scale, growth and execution to drive patient access and performance. It's also the reason why Region Europe is at the center of our BIO 100 ambition. As the largest Sandoz region, accounting for over half of global sales, our growth is critical to overall Sandoz success. We'll continue to provide the greatest absolute growth and will, therefore, always be the foundation for success through BIO 100 and also beyond. To repeat, the fundamentals here are highly attractive. We see the European biosimilar and generic market growing from roughly USD 75 billion in 2023, to over USD 180 billion by 2035. But what is particularly important is the mix biosimilars are the key growth engine with a projected market growth of 15% per year, while generics continued to grow steadily at mid-single digits per year. As you can see on the right side of the slide, we look at a market that is expected to grow strongly and become more biologic driven, which plays directly to our strength. Growth is expected to be driven by three structural trends. The first one is a larger wave of biologic expiries of up to 15 molecules by 2035. The second one is a generic loss of exclusivity pipeline, which will secure our growth in generic. And the third 1 is ongoing biosimilars launches that will lift the biosimilar contribution from 21% in 2025 to around 39% in 2035. Now turning to our performance over the last few years. This slide shows that we are already well on track. As you can see, European net sales increased from approximately USD 5 billion in 2023 to around $6 billion in 2025, representing 6% annual constant currency growth and 9% volume growth, with biosimilar growing 15% per year, more than twice as fast as the overall business. The steady growth underpinned by a constantly improving product mix reinforces our leadership position and gives us confidence as we start to execute on BIO 100. Now digging a little bit deeper, you see here that our biosimilar market share has now reached 28% driven by both the continuous strong performance of our 13 in-market biosimilars and our proven leadership in biosimilar launches, one of our key competitive advantages. Note that we successfully recovered share after previously growing slightly below the market. When we launch a biosimilar regardless of competitive density in the market, we typically achieve a #1 or #2 position, consistently demonstrating our ability to execute at scale and speed. Thanks to our launch preparedness and capabilities, we are now with 9 out of 13 launched biosimilar being #1. Coupled with over 86% tender win rate, we are the #1 biosimilar company in Europe, and now with 28% biosimilar market share, demonstrating clear evidence of both commercial strength and excellence in market access. Moreover, we anticipate a wave of five launches in the next 24 months, which will further reinforce our leadership and support continued growth. Let's look into more details at our two most recent launches, Afqlir and Wyost and Jubbonti. With Afqlir, success started well before launch. We combined IP strategy, a differentiated formulation, manufacturing readiness and country-specific execution to achieve first-to-market availability across Europe. In tender markets such as the U.K., we translated early availability into rapid contract wins. In substitution-based markets, we ensure broad supply and pharmacy confidence from day one. And in physician-driven markets, we engage customers early and focus on reliability of supply and execution. The result was a rapid leadership update with a biosimilar market share of around 80% for the region. And we see the same play when it comes to Wyost and Jubbonti. Despite a highly competitive environment, rapid launch preparation enables day one availability across multiple countries while our broad European footprint allowed us to execute simultaneously across different market archetypes. This resulted in a strong early market position across both osteopath and oncology segment despite intense competition. This proven and repeatable launch model continues to deliver market-leading position, and I'm confident that we will continue to perform consistently well as we execute on BIO 100. Now this is an important slide, so I will spend a little bit more time on it. In addition to launch excellence, two other key differentiators are what we call our local market intimacy and our local execution model. It's a model that is easy to describe, but extremely hard to replicate successfully. It's like the old adage, think global, but act local. What sets us apart is our ability to consistently take what is the major barriers for most of our competitors, the sheer complexity of the European market and turn it into a competitive advantage. As I explained earlier, we have built commercial platform based on all three market archetypes and we win at every level from tenders with health care or government organizations through share of votes with prescribers to substitution at pharmacy level. All of this enabled by our competitive COGS as well as capabilities built over time through deep stakeholders' relationship and best-in-class market access. Importantly, these archetypes continue to evolve. We see increasing elements of pharmacy substitution in markets such as France or Switzerland, while procurement mechanisms in Germany are becoming more structured. We view this development as a continuation of trend we already manage across Europe rather than a fundamental change in the competitive landscape. Because we operate successfully across all three archetypes today, we are well positioned to adapt our model as the market will continue to evolve. For example, in the U.K., success is often driven by tender execution and supply reliability. In France, market access increasingly depends on the ability to execute at pharmacy level. And in Germany, physician engagement remains critical, while procurement mechanisms continue to evolve. And in most of the countries, we have an end-to-end approach. We are one of the few companies with the capability to support both prescriber engagement and pharmacy execution, helping ensuring patient access from prescription to dispensing. Our strength comes from being able to win across all three environments rather than trying to apply or adapt a single commercial model to different market frameworks. Finally, on the right-hand side of the slide, you can see the impact of two tangible biosimilar examples. Both pegfilgrastim and adalimumab biosimilars have demonstrated rapid biosimilar uptake driven double-digit growth ensure significant health care system savings and help us to deliver on our purpose pioneer access for patients. So we have talked about launch excellence and our strong local affinity. Our scale and heritage are also significant competitive advantages for us in Europe, supporting sustainable growth and leadership in our home markets. So Europe's health care system face budget pressure, fragmented market dynamics and evolving regulation, posing significant commercialization barriers. In this environment, scale, local presence and end-to-end capabilities really matter. Our strengths extend beyond commercial execution and include IP strategy, regulatory expertise, manufacturing reliability and supply network execution allowing us to consistently launch and scale biosimilars across Europe. All of which brings me back to my main point, why Europe is the foundation of our BIO io 100 strategy? As Europe is the largest Sandoz region, it is the engine for all of our future growth plans. As I mentioned before, it is the absolute growth that matters because this translates into patient treatment and also into absolute sales. Now to how we will get there? We already operate at significant scale across more than 40 countries with above market growth and a clear #1 position in both biosimilars and generics. At the same time, we are building for the future. So the targeted expansion from 13 in-market biosimilars globally today to more than 100 by 2040 is supported by an increasingly broad biosimilar pipeline, which has recently expanded to 39 assets and with the potential to increase up to 46. This will be done through our cooperation with [ Elias ]. This does not require a complete transformation or significant expansion of our existing commercial organization. Our existing teams already manage a field force of over 2,300 sales reps. They already engaged with the relevance to customers and stakeholders daily. As a result, each additional biosimilar can increasingly leverage the same commercial platform, creating attractive operating leverage as the portfolio expands. So in Europe, BIO 100 is a highly focused progression from a position of strength and heritage today. We are already set up for success, thanks to our scale, our existing #1 position in biosimilars and our proven ability to execute across all three market archetypes. This is the solid foundation that I believe will allow us to carry on winning as the market develops and grows. Until 2030, the focus will be on expansion and the next five launches will be an important proof point. Unlike some recent launches where we benefited from first-to-market positions several upcoming products will enter more established competitive market. Our focus, therefore, extends beyond launch timing along and will include leveraging our scale, market access capabilities, customer relationship and execution excellence to continue gaining leadership position. In the affordable medicine industry, leadership is defined less by individual product and more by the depth and the breadth and continuity of the portfolio we build. By 2035, the ambition is clear to accelerate Sandoz as Europe's leading and most trusted biosimilar angering company, not just by size, but by consistency of execution, reliability and value delivered to health care systems and obviously, to patients. Thank you very much for listening. And with that, let me hand over to Peter, who will take you through how we plan to continue our success in the international region.
Peter Stenico
executiveThank you, Christophe, and good afternoon, everyone. It's a pleasure being here today. My name is Peter Stenico. I'm the President of Region International, the second of our three world-class commercial engines worldwide. I have spent 25 years with Sandoz from seeing Omnitrope come to market in 2016, to launching multiple biosimilars across Europe and Germany, and this experience has given me a firsthand perspective on how we have built, scale and let in that space. Our international markets represent a significant and highly attractive growth opportunity, powered by expanding access, rising demand for affordable medicines and rapidly evolving health care systems around the world. All this is made possible, thanks to a highly experienced, passionate and fantastic team in Region International. In the next few minutes, I'll walk you through how we are scaling our platform, accelerating our growth and how we intend to further strengthen our leadership in both biosimilars and generics across these markets. Our international business is a focused, scalable platform with a strong history of growth and even stronger growth prospects. In 2025, the similar market in our region was worth USD 3 billion and is set to grow by 19% per year in coming years, a clear tailwind for sustained expansion. We are highly selective in how and where we deploy capital, focusing on the most attractive markets, i.e., those where our capabilities best set us up to succeed and make a difference for patients. We have a direct presence in more than 20 countries and an additional 30 markets are served through a capital-light distributor model. We have a leading position across our core markets with well-established commercial infrastructure and the proven ability to maximize global scale with highly tailored localized execution. Our strong position translates into impact at scale as the region reached around 280 million patients annually while helping to improve access and strengthen health care systems. All in all, this is a disciplined high-growth platform, combining sharp market focus and strong local execution, backed by a strong global pipeline to drive sustained value creation. International is shifting structurally towards the higher-value segment of biosimilars, and we are well positioned to capture that upside at scale. The overall market is expected to grow from around USD 70 billion in 2023 to more than USD 140 billion by 2035 with a particular focus on biosimilars which are expected to grow by 19% per year. Biosimilars have historically represented a smaller share of overall sales compared with our European markets in the U.S. This has largely reflected structural market dynamics, including varying levels of health care system maturity and a slower pace of biosimilar adoption. Today, however, we are seeing a clear inflection point. Health care stakeholders are increasingly focused on expanding patient access and improving system sustainability. These dynamics, together with the volume of LOEs over the next decade and the strong growth trajectory of Region International markets is creating a more favorable environment for biosimilars in international markets with total biosimilar sales expected to reach $17 billion by 2035. Biosimilar growth in our market is clearly reflected in our financials with sales up 27% per year over the past 3 years, significantly outpacing generics and accounting for 21% of our total sales today. Crucially, this has translated into consistent commercial performance, and we are #1 in biosimilars across the region, giving us both scale and diversification across key molecules and therapy areas. Our biosimilar market share in the region has expanded to around 14%, clearly ahead of competitors, supported by a strong track record in tenders. And over the past 5 years, we have translated market share gains into clear regional leadership. Interestingly, our market share is growing, thanks to both new launches such as Wyost and Jubbonti, and long-term assets like Omnitrope. On the next slide, let me dive deeper into Omnitrope as an example that highlights how we win consistently and across our markets. Over the past 4 years, we doubled our market share in Omnitrope across region from 16% to 32%, gaining significant ground against incumbent competitors. This success has been driven by a unique combination of local execution and global scale. In our markets, we build preference to a targeted physician engagement, comprehensive patient and caregiver support programs and market-specific pricing strategies tailored to both share of voice and tender markets. At the same time, our global supply network and in-house development capabilities ensure reliable access, device innovation, strong patient adherence. These are clear differentiators in a competitive set of markets. And the outcome is a proven scalable model that consistently delivers growth, expand patient access and sustains our leadership position even after substantial time on the market with a given asset. Our ability to turn regional complexity into true competitive advantage allows us to establish new brands as well as keep growing in long-standing assets such as Omnitrope. With 12 in-market assets across more than 50 countries, our breadth across markets and products, create durable leadership position that we continue to build on. We do not apply a one-size-fits-all approach. We are disciplined in where and how we deploy capital, combining scale and flexibility in over 20 markets with a direct presence, complemented by capital-light distributor model across 30 additional countries. We constantly review our footprint to ensure we can compete effectively and make a difference for patients. At the same time, we remain open to innovative partnership models, further enhancing our ability to scale efficiently and with speed. Our global scale is amplified by strong local customer trust, and a tailored go-to-market model. I will now take you through some examples in the following slides. We hold #1 positions across Australia, Japan and Brazil, each underpinned by locally tailored execution models. In Australia, we lead with breadth and first-to-market execution, supported by a strong presence across both retail and hospital channels. Our position as the #1 biosimilar player in Australia with 11 molecules commercialized across community and hospital channels gives us deep customer relations, strong distribution capability and illustrates our proven launch execution, combined with one of the industry's strongest biosimilar pipelines, Australia is well positioned to remain an important growth market for Santos over the coming decade. Over in Japan, we combine strong customer relationships across the broad spectrum of stakeholders, including prescribers, co medicals and pharmacists with targeted partnerships allowing us to maximize reaching a more complex substitution environment. By 2030, we aim to have over 10 biosimilars on the market in Japan, commercialized jointly with strong local partners to extend our reach. And now in Brazil, success is driven by a dedicated specialty model and long-term government partnerships that give us access and scale. Sandoz Brazil, therefore, holds a strong position in the local health care sector with a broad portfolio coverage among nationwide retail partners, established relationships with major nonretail specialist channels and the relevant presence in the public market through public private technology transfer agreements, tenders and strategic alliances. On the following page, I'll give a practical example of how Sandoz translate by a similar scale in the tangible patient impact in Brazil, one of our most important region international markets. In Brazil, we have built a productive development partnership with the Ministry of Health, combining long-term supply with progressive technology transfer to local manufacturing. This model delivers three things: first, access. We bring biologic therapies to patients who would otherwise not be able before private care. Second, system strengthening -- we support the development of long-term public health care infrastructure and know-how. And third, scalability. This is not a one-off. We have proven that this is a repeatable, sustainable model to expand similar access. You can see the impact clearly with adalimumab. Since the introduction of the PDP, the number of treated patients has increased by approximately 45% from 58,000 to 84,000 with over 25,000 additional patients gaining access. Today, around 30% of public demand is covered by Sandoz. This is exactly how we think about biosimilars, not just as a treatment opportunity but is a long-term access platform, creating value for patients and health care systems. So far, I took you through our track record for our footprint and portfolio. Now looking into the future, we are a critical turning point. Over the past 20 years, we have successfully delivered 57 launches across our largest biosimilar markets. Over the next 5 years, we expect to double that number. With health care systems and regulatory frameworks maturing in our region, complemented by the appropriate internal regulatory strategies and commercial capabilities we are now well positioned to accelerate our growth going forward. And our strategy is already taking effect. To give you some examples, last year, we launched Wyost and Jubbonti, first to market in Australia and in Brazil. For the first time in 20 years, we launched a biosimilar international region in the same year as Region Europe. Going forward, this will become the norm. This year, we received approval for [ Truco ] in Mexico in 30 days, and Jubbonti in Egypt in 45 days, leveraging fast track and reliance procedures. These achievements highlight that over the last two decades, we have built the commercial, regulatory and operational engine required to operate impactfully. With that foundation firmly in place today, we are now well positioned to capture a substantial market opportunity and extend our leadership over the coming years. Now to bring it all together on one slide, the road map to how Sanders International region will be a key driver of incremental value with the context of BIO 100 strategy. First, we start today from a position of strength. Across Sandoz International, we are the #1 player in biosimilars, and number two, when we combine biosimilar and generics. Second, our global scale is amplified by strong local customer trust and a tailored go-to-market model. And third, we are highly disciplined in how we prioritize launches across countries, aligning each asset with the most attractive markets to maximize value. Over the next 5 years, our end market portfolio will expand significantly, and more importantly, we are increasingly launching those assets first to market, reinforcing our competitive edge and increasing our patient impact. Our ambition for 2035 is to be the clear market leader, but it doesn't stop there. We also want to drive higher adoption of biosimilars to further increase patient access and to expand the market. We are looking at roughly doubling international regions biosimilar penetration in the next 10 years with key markets like Australia, going from 26% today to 51% by 2035, and Japan increasing penetration from 15% today to 51% by 2035. So in closing, what we said is in the International Region look like in 2035. We expect to have extended market leadership based on a high-growth platform with the capabilities to translate Sandoz global scale into clear local leadership. The international region is not simply participating in Bio100 opportunity. We are one of the key engines that will convert that opportunity into sustainable growth, attractive returns and lasting value for patients and health care systems. With that, I'll hand over to Keren to walk you through our third regional commercial engine, North America.
Keren Haruvi
executiveThank you, Peter. Good afternoon, everyone. Every day, millions of patients depend on medicines that can improve and extend their lives. Yet for many, access remains a barrier. Expanding access to the medicines they need at the cost they can afford is what drives my team every day. I'm Keren Haruvi, President of North America. It's a privilege to be here and a moment I approach with both pride and humility. Over the past several years, the team in North America has remained firmly focused on doing what we said we would do. We delivered consistent growth, advanced our position in the market and most importantly, build capabilities that are increasingly difficult to replicate in one of the world's most complex health care markets. The one message I want you to take away today is that the question is no longer whether we can win. We have already demonstrated that we can. The question now is how we can replicate that success across the next wave of biosimilars consistently and at scale. North America, the world's most dynamic and competitive health care market stands as a core growth engine for Sandoz. The region represents 22% of our global net sales, serves approximately 140 million patients annually and Sandoz ranked second in the region across the biosimilar and generic markets. That scale did not happen by accident. It reflects a focused strategy, disciplined execution and a deeper understanding of what it takes to win in this market. Our success in the region is built on a focused portfolio strategy. Biosimilars drive growth, while generics provide stability, scale and a strong foundation. The biosimilar market in North America is highly attractive, growing at approximately 23% and representing one of the most significant growth opportunities of the next decade. In the U.S., approval does not automatically translate into adoption. Access is fragmented across pharmacy benefit managers, payers, providers and health system, and uptake is shaped by formulary design, reimbursement dynamics and provider confidence. To capitalize on this opportunity requires the capability to convert access into adoption through market access expertise, trusted customer relationships and disciplined execution. Approvals create opportunity. Adoption creates value. The biosimilar market is at its inflection point. Biologics today account for a disproportionate share of health care spending, yet access remains limited. In the U.S. today, approximately 2% of patients receive biologic medicines, while those treatments account for roughly 50% of total drug spend. At its core, this reflects one of the largest opportunity in health care today, expanding access to advanced therapies while improving the sustainability of the health care system. We are also seeing encouraging momentum across the broader environment. Policymakers are increasingly focused on affordability, payers are under growing pressure to manage specialty drug spend and the U.S. health care system already understands the value of competition through decades of generic adoption. But as the U.S. experience shows, access and adoptions are not the same thing. Take Humira, the largest loss of exclusivity in history. Despite multiple biosimilar launches, adoption is taking time. 6 months after 10 companies launched, biosimilars have captured just 1% of total adenumab share. One year later, biosimilars still accounted for less than 20% of total volume across channels. And even into 2025, Humira continued to retain a majority share in key markets. The lesson is clear. Market entry alone does not guarantee adoption. In contrast, markets like Canada demonstrates what is possible when barriers to biosimilar adoptions are removed, when transition policies are aligned, biosimilars adoption has been faster and penetration has increased significantly. Our responsibility and opportunity are clear, but success will still depend on execution. That means accelerating adoption through policy engagement, partnerships, customer education and disciplined commercial execution to ensure biosimilars deliver on their full potential because we are not waiting for the market to evolve. We are actively shaping it. Let's turn to our recent performance. Since 2023, total net sales from biosimilars and generics have increased by an average of 7% per year. Biosimilars have been the key growth driver, expanding from $500 million to $800 million, a 36% CAGR. At the same time, our generic business has remained broadly stable at around $1.6 billion, reflecting disciplined portfolio management in a more mature and competitive market. What you see here is the evolution of our portfolio with biosimilars becoming an increasingly important growth driver in North America, while generics continue to provide scale and resilience. What is also important to mention is that since 2022, we have successfully stabilized the generic business in the U.S. after multiple years of decline. Our results demonstrate that we are well positioned for future growth, and our recent performance gives us confidence that we are already making meaningful progress and impact. Strong performance in both the U.S. and Canada now makes Sandoz the third biosimilar player in the region. This reinforced that we are not only competing at scale, but we are also leading with many of the biosimilars we have launched. Across key biosimilars, including adalimumab and denosumab, we have achieved leading positions, demonstrating that we can translate launches into competitive share gains in highly dynamic markets. This reflects our access capabilities, customer relationships and disciplined execution. But the largest growth opportunity remains in the U.S. and winning there requires more than strong position today. It requires understanding how decisions are made, how adoption happens and how to convert market complexity into sustained growth. To understand how we win in the U.S., it's important to recognize that the U.S. is not a single market. It is 2 access system operating side by side. On one side is the pharmacy benefit channel, where access is largely controlled by pharmacy benefit managers through formulary decisions that shape patient access and prescription volume. Winning here requires strong contracting, formulary access and reliable supply at scale. In the medical benefit channel, medicines are administered by physicians or infusion centers and adoption happen across a highly fragmented provider landscape with more than 20,000 sites of care. Winning here requires reimbursement confidence, trusted customer relationship and local execution along with reliable supply. What sets Sandoz apart is our ability to compete across both channels. We don't view this complexity as a barrier. We view it as a competitive advantage. We've built the capabilities, relationships and expertise required to navigate both markets at scale. Let me bring the U.S. model to life through 2 examples. On the pharmacy benefit side, TYMoz, our adalimumab biosimilar, showed how we can expand access at scale in a crowded U.S. market. When traditional access pathway were constrained by originator contracting and formulary dynamic, we took a different approach. By introducing private label, we created an additional access to patients, expanding both reach and market share. This was made possible by strong customer partnerships, reliable supply, and disciplined execution. On the medical benefit side, Wiz and Qvantig, our denosumab biosimilar show what it takes to lead in a fragmented market. Success required expertise in IP, disciplined launch execution, a deep understanding of the provider landscape, reimbursement support and reliable execution across many sites of care. Together, these capabilities allowed us to move quickly, establish an early leadership position and demonstrate our ability to win. The question is no longer whether we can win. The question now is how we replicate that success across the next wave of biosimilars consistently and at scale. So what makes us successful? It starts with our people, a team with deep market expertise, trusted customer relationships and the ability to win in one of the world's most complex health care market, all grounded in our purpose of pioneering access for patients. Three capabilities define how we compete. First, a commercial mindset. We see complexity not as a constraint, but as an opportunity to create new pathway to access. Private label and Sandoz Direct are a great example of how we've turned that mindset into action. Second, agility. In a constantly evolving market, success requires speed, adaptability and decisiveness. And third, execution because strategy creates value only when it is delivered consistently, launch after launch, customer by customer, patient by patient. Everything we do is focused on one goal, expanding patient access at scale. Bio100 is not simply about launching more biosimilars. It's about scaling the model we have already proven to win consistently across the next wave of biosimilars. As our portfolio expands, the capabilities we have built become even more important. We will continue to build on our leadership in the region through scale, supply reliability, disciplined execution and ongoing policy and regulatory engagement that helps us remove barriers to biosimilar adoption. At the heart of Bio100 is a simple goal, turning portfolio breadth into greater patient reach and sustainable growth. We have the capabilities, experience and focus to become the leading biosimilar company in the market. As we look ahead, we have a clear road map to set the industry standard for biosimilars in North America with defined strategic ambition at each stage. Today, we are already a leading player. We have delivered consistent pipeline execution, pioneered new models to expand access and build the customer relationships and local market expertise required to win. By 2030, our ambition is to become the leader in biosimilars. That means advancing a leading pipeline, scaling a proven operating model and being the partner of choice. By 2035, our ambition is to be the market leader in the region with the largest biosimilar portfolio, strong customer partnerships and North America serving as a strategic growth engine for Sandoz. What matter most is the patients we reach. Every few seconds, a new patient starts on a standard medicine. That is the impact behind everything I shared today. Thank you, and I will hand over to Remco.
Remco Steenbergen
executiveThank you, Keren, and hello, everyone. It's great to have you with us today. It's my pleasure to walk you through how Sandoz will transform these ambitious plans which have just heard into reality. My colleagues have already highlighted the progress we have made since we became independent. I want to highlight what this means for us from a financial perspective and why it matters as we prepare to deliver on our next chapter in Bio100. As you can see on this slide, we have had strong sales growth and through sustained operating leverage, we expanded our core EBITDA margin and driven strong levels of cash. The return on invested capital has increased above our expectations, and we have driven material core earnings per share growth at the same time as strengthening our balance sheet. To summarize, we have been disciplined in our execution and absolutely laser-focused on our strategy, which has translated directly into clear value for Sandoz and therefore, the patients we serve. Now let me outline what this looks like at the business and regional level. From a business perspective, I would like to share with you how we performed across both our biosimilar and generic businesses. Between '23 and '25, net sales increased on average by 7% biosimilars were the key driver with annual growth of 21%. Importantly, we reached our 28 ambition of 30% of net sales coming from biosimilars 3 years earlier than planned in 2025. That achievement underlines both the market demand and our successful execution, including such launches as Hyrimos, PSiva, Wyost & Jubbonti. With a market share of 19%, we remain a clear global leader in biosimilars. At the same time, our generic business has continued to be strong and resilient, growing in line with the market at around 2% and providing a unique foundation for our biosimilar growth. With a market share of 4%, we are 1 of the top 2 generic companies globally. So overall, we are combining high-growth biosimilars with a strong generic business, driving both the scale and the quality of our growth. As you have heard from our regional presidents, our geographic track record also underlines the strength of our biosimilar and generic portfolio, with the former as the key engine of growth across every geography. As you have heard from Christophe, Europe delivers the majority of our sales and remains our most established market, growing from $5 billion in '23 to around $6 billion last year. That translated into a 6% CAGR overall, with 15% for biosimilars, again, for the period '23 through '25, reflecting continued market expansion and our ability to grow our leadership position. In International, an overall annual average growth of 8% and 27% growth in biosimilars for the period '23 through '25 also shows the incredible potential for this region with Bio100. But North America is where we see the most pronounced momentum with a 36% biosimilar CAGR, driving 7% overall growth for the period '23 through '25. This reflects the strength of our execution in both the U.S. and Canada with strong recent launches, increasing physician adoption and ultimately improved access for patients. Now turning to the future and the impact we believe we will have with Bio100. Today, our pipeline covers around 50% of biologic LOEs by value. With Bio100, we intend to increase that coverage to around 80%. This is a real change in scale, meaningfully benefiting patients and health care systems all around the world and positioning us to fully capture the upcoming wave of biologic LOEs. In the next few years, a significant part of these new launches will be enabled through business development and licensing, allowing us to move quickly and secure attractive assets. Over time, however, our international pipeline will become -- sorry, our internal pipeline will become the main contributor, reflecting the strength we have built in development capabilities and platform expertise with targeted benchmark cost levels for development and manufacturing. Now I want to focus on how we will translate this momentum into long-term growth. As Richard said earlier, we expect to more than double our net sales by 2035 versus last year. By that time, biosimilars would represent the majority of our net sales. Looking further ahead, we are targeting to increase our biosimilar global market share from around 90% currently to around 20% to 40%. At the same time, our generic business will remain very important and cash generative, and we expect to grow in line with the generic market. So what you see here is the transformation of our business from a generic-led portfolio to a biosimilar-led growth company. In addition, we also expect to see a step change opportunity for GLP-1s by 2035, which, as Rebecca said earlier, is too early to quantify now. To be clear, this long-term GLP-1 ambition is over and above the doubling of net sales by 2035 through Bio100. Now let me break this down a little bit further by first looking at the midterm outlook. I'm delighted that we are today confirming an unchanged 2028 outlook. This includes the expectation for net sales to grow by a mid-single-digit percentage at constant currencies through '28 with a core EBITDA margin in the range of 24% to 26% by that time. But as of today, we're also extending the lens beyond '28. With our new midterm outlook, we expect net sales growth to accelerate to a mid- to high single-digit CAGR from '25 through 2030. This will be back-end loaded. The core EBITDA margin is also expected to expand further to within a range of 25% to 27% by 2030. To be clear, the new 2030 midterm outlook includes GLP-1s. Our dividend policy will remain unchanged with dividends expected to increase to a range of 30% to 40% of core net income from 27% in '25. Strong capital discipline will continue with investments in Bio100 expected to pay off not only in terms of higher growth, but also in terms of increased core ROIC, which is targeted to be in the range of 16% to 18% by 2030 versus 14.5% last year. Upfront funding is set to be followed by accelerated growth. Bio100 is about deliberately investing an additional USD 2 billion to USD 2.5 billion over the coming 5 years, investing in our pipeline, portfolio capabilities and manufacturing assets to unlock even more value-accretive growth. But 2030 is not the endpoint. In fact, this is when it scales will really get interesting. We are targeting to more than double our '25 net sales by 2035, plus GLP-1 related sales that are expected to be material, but again, are too early to quantify now. That means double-digit growth in the 2030s, which will be accompanied by targeted core EBITDA margin of at least 30% and targeted core ROIC of at least 20%. We believe that this is an attractive high-growth, high-quality earnings profile, which we see as a real opportunity for Sandoz and our shareholders. For those of you who are thinking this is ambitious, but how realistic is it? Let me point out that between now and 2030, we have multiple well-identified levers that support increase in core EBITDA margin. First, price erosion is expected at a mid-single-digit percentage, reflecting the increasing size of the biosimilar launches over the coming years. But more than offsetting this, we see strong tailwinds from the mix of sales. Second, we expect to deliver further operational improvements and procurement savings each year, which should result in efficiency gains and reduce costs. Third, with our top line increasing significantly, operating leverage is expected to further improve as we absorb operational expenses more efficiently. We expect these SG&A costs to decline as a percentage of sales, reinforcing the margin trajectory. Finally, we are making targeted disciplined D&R investments while benefiting from regulatory streamlining. Some of these investments will continue to be capitalized in line with our existing accounting policy, but it means that D&R as a percentage of sales is expected to remain broadly in line with current levels. Now the 2030s is where the real step change cost of goods sold opportunity begins, reflecting in-house vertical integration of biosimilar development and manufacturing, as Armen outlined earlier. As of the 2030s, we'll have biosimilar development and manufacturing operating at scale in-house, strengthening by the multiple new biosimilar development, drug substance and fill/finish sites in Slovenia and by the -- just Evotec acquisition. This means greater control, faster execution and importantly, capturing more of the value chain in-house. With these sites, we will be driving ongoing process optimization, continually improving yields with proportionately fewer third-party additional costs. And finally, scale. As we grow, we intend to unlock significant capacity advantages, allowing us to produce more efficiently and support future pipeline expansion at limited incremental cost. So we intend to structurally redefine our cost base and strengthen our long-term competitive advantage. That's the real impact of Bio100 from 2030. Now turning to one-off costs. As you can see, this peaked in '24 at around USD 700 million and expected to decline to around USD 300 million this year. This is expected to reduce to around $200 million in '27 and around $100 million in each of the years thereafter. This reflects the final phase of the transformation and separation programs, the completion of the simplification and transformation of our supply network and organizational structure and the implementation of new state-of-the-art IT systems. Next year, we still expect around USD 100 million of IT separation costs from our former parent company and around USD 100 million for transformation programs, which we expect to continue around this level in the years thereafter. As such, we expect only limited one-off costs going forward. For completeness, this excludes legacy litigation costs and software implementation cost accounting impact. Now turning to CapEx. As you have heard from Armin, we have already significant investments underway in Slovenia. You see that reflected in our CapEx expectation of around USD 1.1 billion for this year. We expect similar annual U.S. dollar capital investments for each of the years over the midterm, which means that CapEx should decline as a ratio to net sales from this year's 9%. With Bio100, we will see better asset use, higher throughput and more efficient tech transfers, allowing us to absorb growing volumes within our existing footprint. In terms of free cash flow, as I mentioned earlier, versus our prior plan, we intend to spend around USD 2 billion to USD 2.5 billion more, mostly in D&R, but also partly on further manufacturing expansion. And again, this includes the benefit from regulatory streamlining. At the same time, we intend to continue our very disciplined working capital management. Therefore, free cash flow is expected to grow by around a further 50% by 2030 versus last year. Consequently, a further reduction in the ratio of net debt to core EBITDA is expected by 2030. Overall, this underpins a clear plan of investments in Bio100 while ensuring growing cash generation and continued deleveraging. This slide brings together the 3 pillars that underpin our financial strategy. disciplined capital allocation, improving quality returns, core ROIC and financial resilience. Our Bio100 priority for capital is clear. We're going to reinvest into our biosimilar business for accelerated growth. At the same time, we remain selective on business development, focusing on value-accretive opportunity. All of this will be complemented by a progressive dividend policy. What we'll do is anchored in maximizing capital efficiency. We will be focused on driving the further step-up in core ROIC over the midterm, supported by Bio100 and continued margin expansion, while maintaining strict discipline on working capital. Finally, financial resilience will remain key, and our track record shows that we do this well. Our model is built on sustained cash generation, a clear commitment to maintaining an investment-grade rating and a strong balance sheet that gives us the flexibility to invest and grow. Moving on, I want to take you through more details of our plans to increase core ROIC as set out on the prior slide. We have a very deliberate focus on quality growth and investment discipline. On growth and profitability, we're accelerating our shift towards biosimilars, where we see structurally higher returns. At the same time, vertical integration in biosimilars will deliver significant long-term benefits, and we expect further operating leverage as OpEx costs grow slower than net sales. On invested capital, we are focusing on deploying capital with discipline. Investments into the biosimilar pipeline will benefit from regulatory streamlining, of vertical integration will further enhance efficiently. Importantly, our generic business will continue to act as a cash engine. Therefore, we are targeting to improve the speed and the quality of growth through a better business mix and drive higher margins, disciplined capital deployment and resilient cash management, resulting in a structural step-up in core ROIC. The strong growth and the higher core ROIC combined are intended to deliver excellent long-term value creation. Bringing this all together, what you see is a company with proven leadership and targeting clear acceleration ahead. Since the spin, we have performed consistently well, driven by our strong and sustained growth in biosimilars across every region. At the same time, I hope you see that we're providing clear visibility, confirming our 2028 outlook while providing a new and exciting midterm outlook for 2030 as well as significant ambitions for 2035 and beyond. With Bio100, we will be doubling down by targeting a portfolio of more than 100 biosimilars supported by increased absolute D&R investments and opportunities enabled by regulatory streamlining. And we are optimizing our supply network. With all of this, we expect to drive enhanced top line growth, profitability and ROIC. Now before I hand back to Richard to close this out, I have to say that as a CFO, it's incredibly rare in a career to be in this position, presenting to you with this company with a proven track record at this moment in time when we have an unprecedented commercial opportunity ahead of us. And if you get this right -- correction, when we get this right, it will mean we can make affordable health care reality for countless patients. This is a moment which is not lost for me or any of us. Richard, over to you.
Richard Saynor
executiveThank you, Remco. You'll be glad to know. I'll just take a couple more minutes to get us over the finish line. This could not be a better time for Bio100 and patient access. Firstly, there is a huge patient access need as biosimilars and generics represent the vast majority of prescriptions worldwide, but only account for around 30% of their total cost. These medicines are affordable and are core for health care provision, supporting scalable adoption. Secondly, there's an exceptional market opening. We are entering an unprecedented wave of loss of exclusivity for biologics with over $300 billion up to 2040, creating a once-in-a-generation opportunity. Good, development and manufacturing, regulatory streamline is now a significant tailwind for Sandoz and is now combined with the first-rate supply chain capabilities with capacity. Together, this creates a uniquely attractive environment and timing that positions Sandoz perfectly to scale growth while expanding patient access faster than ever before. In case I wasn't already clear, Bio100 is not just an ambition. It is a clear strategic road map. We start from a position of strength today with a deep biosimilar portfolio and a proven global platform. From here on in, it's about disciplined execution, building our launch engine to get around 30 biosimilars in the portfolio by 2030, then scaling investment as we plan to expand by around 70 by 2035 and then over 100 by 2040. I said at the beginning that there are only really 3 messages that I should leave you with today: purpose, ambition and delivery. Our purpose remains the same. We are remaining driven by our commitment to expand access to high-quality affordable medicines and drive meaningful benefit for more than 1 billion patients. We have a clear ambition to have more than 100 biosimilars in market by 2040. And along the way, we have a comprehensive delivery road map on how it leads to double our net sales by 2035 versus last year and deliver a core EBITDA margin of above 30%. Finally, I would like to take this opportunity to acknowledge our 22,000 colleagues who have been and will be the ones that bring this opportunity to life. All of us are united with a clear purpose, pioneering access for patients because by pioneering access, we expand it. And as Gilbert said right at the beginning, this is anchored in strong values, collaboration, ambition, accountability and openness. Together, this gives us a highly aligned, motivated organization ready to deliver on our Bio100 targets. And we're making the most of this upcoming golden decade for our colleagues and our shareholders and most of all, the billions of people like Cheryl and Gustavo who have the basic right to affordable health care. Thank you. Now we'll be happy to take your questions.
Craig Marks
executiveOkay. Same format as before. Wow, look at the hands up. That was amazing in terms of the hands up rates.
Richard Saynor
executiveI'm going to start with Harry because I was conscious Harry, did we answer your question, because I think that was...
Harry Thomas Sephton
analystHarry Sephton from RBC. It's actually going back to the CapEx point, which I think Thibault raised earlier. So you previously talked about CapEx spend really peaking in 2026. You're now saying that, that absolute level of CapEx is going to carry forward. That has quite a meaningful impact on free cash flow going forward. So I just want to challenge what's changed that means you've got a higher capital intensity going forward.
Remco Steenbergen
executiveSo Harry, thank you for the question. As I said, Bay 100 requires to additionally invest about $2 billion to -- and that is partly in the NR, and that is partly related to CapEx. So the manufacturing will have to ramp up as you go to the 80% LOEs. The CapEx also include part of the development costs, which are capitalized. So that's also included because that's also more than we originally had foreseen. So as a percentage, it comes down as an absolute amount, it will stay roughly flat rather than go slightly down.
Craig Marks
executiveJames?
James Gordon
analystJames Gordon from Barclays. One question was on the top line. So if I look at the slide, you've given a projection out to 2030 for what the group is going to do, which is mid- to high single digit. And you also said what proportion is going to be biosimilars. But if I back that out, it looks like then that generics would be growing at about 4% versus about 2%, which is what you've done in the last couple of years. I know that the IQVIA projections, they look like it's faster growth, like about 5% growth in the generics market. But I think that's gross without the pricing headwind, which you face. So is that right that the guidance is assuming you're going to do better in generics now because you're going to take more share or the market is going to change? Or am I misinterpreting that? That's the first question, please. So what to put in our models for the generics growth rate for the next few years? The other one was on margins. So on gross margin, I think you previously said biosimilars were something like 20 percentage points higher gross margin and then there's a shift to selling more biosimilars and then you're going to get better making biosimilars. So there should be quite a big uplift there. But if I look at Slide 96, it looks like much of the benefit there is followed up by pricing headwinds. So is that the right interpretation that there's not much gross margin benefit from that sort of mix shift to 2030, and it's really a 2030 to 35%, we get that benefit once the Slovenia side is going?
Craig Marks
executiveDo you have another question?
Remco Steenbergen
executiveSo there's one element on the growth, as you asked, right? There's one, the market growth which is shown in and underlying is what we expect of our own growth. We expect biosimilar to growth in the double digit. There's no change from what we had before. It might even accelerate a little bit. GX, the market numbers you see is including GLP-1. But these are estimates from the market expectation, correct? So we would expect still low single-digit growth of the GX market, excluding GLP-1 and the GLP-1s will come on top of. We have guided for 2030 for mid- to high single digit, including GLP-1. I would say that without GLP-1, we would also probably sit in the mid- to high single-digit kind of growth range. So the biosimilar is really picking up along the way. The range of biosimilar being in gross margin higher than the average of the group that's higher than generics, it's on average still correct. The only thing we have to still keep in mind that it's very different if it's a partnered biosimilar asset or it's an own development asset. So in the shorter years when we have partnered assets, we share the cost, but we also share the profit with the other party. And then net-net, the gross margin is not to the same level when it's fully in-house. In terms of the EBITDA improvement, yes, price erosion is not low single digit, mid-single digit, but we have also seen and we see that the first half of this year, biosimilar grows really a lot and you launch a new product. Of course, in the first year, the price erosion significantly. So that's not so much a margin topic. It's just an inherent implication of launching a lot of biosimilars. Procurement savings, we still expect to continue, right, but not completely offset the 5%. The mix impact will really remain significant, and therefore, net-net, we expect the benefit on the gross margin, and we expect that over the coming years through 2030. Of course, in 2030, when the vertical integration comes in, and we do a lot in-house, we expect significant benefit on our cost prices. And in principle, the gross margin should go more up, but then depends as well what the price erosion is in the 30s, and that's too early to say. However, net-net, we still expect to come to at least the 30% by 35%. How much is then the equation of how the price erosion during that time comes out and the competitive environment.
Richard Saynor
executiveAnd also bear in mind, we'll be transferring a number of the assets that we currently take from our parent into our own network with a corresponding improvement in COGS over time, but that doesn't really kick in until the other side of 2030.
Remco Steenbergen
executiveAnd perhaps the last part is also what the regional presidents clearly indicated. The infrastructure we have on marketing and sales, but also general administrative costs, they should benefit in percentage vis-a-vis the top line very clearly. And that benefit comes then on top of the gross margin and both should drive the EBITDA margin up over time. It's just a mathematical equation.
Craig Marks
executiveThanks, James. I'm going to take a question from the webcast, if that's okay.
Victor Floch
analystSo this is from Victor at BNP Paribas. So it's a U.S. question. You recently said that you wouldn't rule out investing in additional capacity outside Europe in response to the potential threat of U.S. tariffs on generics. With the new investment in Slovenia announced this morning, should we take this as a sign that you remain fully committed to expanding your European manufacturing footprint? Or are investments outside Europe still on the table?
Richard Saynor
executiveYes. The simple answer, I'll let Keren comment about the U.S. I mean we have a clear road map in Europe. The U.S. is clearly as a single market, the single most important growth market. I mean the industry is the largest biosimilar market in the world. So clearly, it's a significant opportunity. I'll let Keren comment about the conversation we're having. We clearly have good dialogues with the U.S. I think if you take a step back, generics and biosimilars account for 90% of all the drugs dispensed in the U.S. or about 11% of the cost the vast majority is supplied overseas. I think in terms of sustainability of health care, it's a critical part, and we're aligned with the administration in terms of how we think about it. But Keren?
Keren Haruvi
executiveAbsolutely aligned with the administration. I think we strongly believe that generics and biosimilars should be exempted from tariff. So far as an industry, we did a very good job. So we would not manufacture in the U.S. just as an answer for tariff, but we are absolutely thinking, as Richard said, is a critical market that we will continue to have the conversation and find a path. It needs to be sustainable and makes sense. So we'll continue to work on that, but absolutely committed to this market.
Beatrice Fairbairn
analystBeatrice Fairbairn with Berenberg. You've talked about moving from a reliance on external CMO supply to about 6 in-house manufacturing. What do you view as the key risks for this? And how conservative you've been about the ramp-up assumptions for this internal capacity? And then if I may, would you give us a bit more of a quantification about how much of your margin expansion target is driven by this ramp-up?
Richard Saynor
executiveThat's a great question. Armin, give Armin the microphone.
Armin Metzger
executiveYes. Thank you for the question. I mean, currently, we are ramping up the capacity on our various sites. I don't know where I should look at actually here. Maybe I stand... So we are currently ramping up. We are building up. We're starting tech transfer. So basically, it's purely execution risk, what we say. Now we have experience in tech transferring. So we are doing it. Actually, we start with products. We take transfer in-house, which we see there is a lower risk of failure because we know the molecule very well. It maybe not the most complex molecule. So we're doing it step by step. So this is what we see. basically, it's rigorous execution, it's performance management, getting a good knowledge transfer from our contract manufacturer that we transfer, but it's normal business actually. And we are in the process of starting it as we speak now on the drug substance side, continued with the drug product side. The second part I didn't get actually acoustically, sorry, of the question. What was the second part of the question? Well, that's a question of from whom we check transfer basically and what technology we transfer. Let's say, on an average contract manufacturer basis, you can have on the truck product side on the finish side, 30% to 50% benefit of the internal cost. Of course, if you be on the truck up, it can be it varies. But actually, for us, important that we can leverage our scale, right, because the alone doesn't save the cost challenge basically. It's about how we utilize our various platforms in the most efficient way, and this basically drives the cost down.
Craig Marks
executiveCharlie at the back.
Charlie Haywood
analystCharlie here with Bank of America. Two questions on sales growth. The first one is to double your sales growth from 25% to 35% implies a roughly 7% sales CAGR. And if we take the midpoint of your mid- to high 25% to 30% sales guide, that would imply maybe 7% to 8% sales CAGR in the 2030 period. You guide to double-digit sales growth beyond 2030. So does that suggest 25% to 30 sales growth closer to the lower end of that to closer to mid? Or does that actually imply upside to the outer year target, i.e., doubling a bit more upside there? And then second one, just on sales phasing, so 25 to 30 mid- to high single digits. I think this year, you're looking at mid-high. I think the implied '27, '28 commentary is mid. And then to get to a mid-high, you're looking at maybe high for '29 and '30. On the moving parts to get to high single digits, is that upside to '29 and '30? Or could we actually see upside to '27 and '28?
Richard Saynor
executiveI think I understood the question. I'm going to let Remco try and answer that one. I mean we can't win. We've given directional guidance to 2035, and you're asking for levels of accuracy.
Remco Steenbergen
executiveThank you, Charlie. I think you did the math very correctly, right? We have guided at least 2x by 2035, right? And we said mid- to high through 2030. We expect double digit through to 2035, and that would be at least doubling. So you can draw your own conclusions. from this and then GLP-1 will come on top of. And if you do the math also based on the molecules and the launches and the different market share, you will see that you will come in a similar equation there. We have guided mid- to high. I've said as well that it is more backloaded, correct? So that also gives already the answer question. It's too early to say on '27, '28, correct? We will give the guidance at the beginning of next year. How that will pan out? Is it mid? Is it mid to high? We will have to see what is. But for the moment, it's indeed, we say backloaded. But thank you for the very good quick math you did, but we are aligned.
Craig Marks
executiveOkay. I'm just going to take one from the -- for the webcast. You might have to bear with me because it's Nicolas from Kepler, and I think he's paid by the word because it's quite long. So I'll try to paraphrase as much as I can. So this was his second question we didn't get to in the first half. So the first question is about manufacturing upside, I believe, but in one of the slides, you mentioned you'd be able to have a significant unit cost reduction from 2030. Any way you can quantify that if we were to compare it to some of your previous comments on biosimilar profitability? If maybe I can squeeze the last one probably for Christophe. I'd be curious to know if you have received any changes in the discussion with the different administrations in Europe since all the MFM noise started. Is there any risk that EU countries would potentially further reduce the price of off-patent drugs, mostly biosimilars to free some additional budget for innovative drugs also, do you see any upside in the mid- to long-term potential from your full EU production footprint when it comes to winning in Europe, more from a European sovereignty angle again as the U.S. is trying to pull the industry there. In brackets, sorry for the question length.
Richard Saynor
executiveChristophe, do you want to have a go at that first part? And then I think we partly answered some of that on the manufacturing side. I mean, clearly, look, it depends also as we define our own pipeline with cell lines, all of those things, there's a lot of opportunities to expand margins. I think Armin covered the bulk of that question. So Europe?
Christophe Delenta
executiveSo the discussion on the MFN and the prices is more about how can we accelerate the penetration of the biosimilar to generate the savings that we are generating today. So you think about generating savings, it's around $10 billion, I mean, today annually from the biosimilars we are launching. And this will be what will be used to obviously accept the launch and the prices for the new -- for the innovators and the innovative products. We do not see prices declining beyond what we have observed in the last 5 years. So no accelerating trend here. Nonetheless, what we see is a shift in archetypes in some of the countries, as I said before. When it comes to protecting the European manufacturing, tomorrow, we'll have the European Procurement Act being disclosed. we believe that most of what we have advocating for in the critical medicine A, meaning favoring European production in the tenders, for example, having a single slot from European productions and the medicines will be there. So this is moving on the right direction, and it will help not only to preserve our European autonomy for the biosimilars, but I'm thinking also for our anti-infective plant in Kunda and moving forward, a definite advantage for us as we will produce in Europe, most of our biosimilars.
Richard Saynor
executivePerhaps 2 builds on that. Interestingly, MFN, I mean you see a number of originators questioning whether they're going to launch assets in Europe. Actually, the sort of philosophical opportunity for us, I think, in the mid- to long term, that we need to get our head around a little bit. Price in most European markets is not a function of the regulator, it's a function of competition. And that's nothing different to today. So if there's 10 competitors, you're competing in a very different way to no competitors. So I think in the majority of European markets, and let's be clear, as we bring Bio100, that is where the European governments can deliver savings. That's a huge opportunity to bring massive savings and access to patients across Europe. Quite honestly, kind of scrape a little bit more out of the 30% that -- the money on the table is really sitting with the originators and the patent cliff.
Craig Marks
executiveShyam, at the front.
Shyam Kotadia
analystShyam From Goldman Sachs. I had a question on going back to the subcu point. So you've got a fair few subcu biosimilars in your pipeline with KEYTRUDAQLx and you've also got other formulation for EYLEA HD. So I just wanted to check, once that compound patent goes up, is that an appropriate time for you to go after it? Or would you need to wait for the actual formulation patents for KEYTRUDA-QLx or EYLEA HD to go off end of 2039, early 2040s? That's the first question. And how does that differ in Europe, U.S. And then the second one, I think you touched on it a bit anyway, but before, I know you mentioned like being a European-focused company and launching in the U.S. was like an optionality and opportunity. Now with Bio100 and regulatory streamlining, are you planning to launch all your pipeline biosimilars in both territories? Or will you be selective still in the U.S.
Richard Saynor
executiveYes. I guess, look, I'll comment on the EU focus first. Let's be clear. My point was more about -- we talked about eanoceptembrel. Of course, we're going to launch in the U.S., but there's always that degree of uncertainty around the U.S. because you've got to go to court, and there's always a question mark whenever you go to court. Of course, the vast majority of Bio100, we will launch in the U.S., either through the strategic partnerships. You've seen the deal terms there or through our clearly for our own development. So absolutely. But I just -- I think it's a subtle shift to say, look, we've got a very clear runway when we launch in Europe. And clearly, the U.S. becomes the opportunity. I think historically, everyone is sort of over-indexed to the U.S. It's just that uncertainty around the patent framework. We tend not to disclose too much about what we're doing in terms of patent because I don't want to make -- I don't think we disclosed a lot in terms of our pipeline, but there is a limit. So that's probably the limit about where we would disclose in terms of what we intend to do with things like subcu and the patent strategy around that. I'm getting a hands up from Ingrid so clearly, I've heard the right thing.
Craig Marks
executiveI think we've got maybe a couple of minutes past 5:00 because there's still plenty of hands going up. James on the front.
James Vane-Tempest
analystJames Vane-Tempest from Jefferies. First of all, just to come back to the double-digit growth in 2030, which is an acceleration. Just wondering how much of that can be delivered from visibility today versus further new pipeline and business development. So as new deals are announced, you essentially know what that means versus your guidance? Second question is, clearly, you're expecting to maintain the level of investments aiming for more than 100 biosimilars in your portfolio by 2040. So how should we think about the phasing to more than 30% margins over time in 2035, given a 25% to 27% range in 2030? And is that sustainable? And then my final question is, it's great to have a longer-term vision, but I was interested in, I guess, your framework and philosophy to regulatory changes, just given how much of that can happen unexpectedly given the long-term framework you've given. So I guess on the positive side, in Europe, there's a Critical Medicines Act, which clearly could be beneficial if that expands. I know it's mainly directed at anti-infectives at the moment, but it could be expanded into other areas. But on the flip side, you've got the Urban Wastewater Management directive. So how are you thinking about sort of managing both the pros and cons of the regulatory framework in your guidance?
Richard Saynor
executiveOkay. Perhaps if I take the third, Remco can take the phasing, and I'm going to pass to Rebecca for the growth drivers beyond 2030. So have we planned in the growth drivers? I'll give you a moment to think about it. Yes. I guess just a couple on -- it's not really the -- it's the regulated, but it's actually the PA framework that drives it, not the regulatory framework. So I don't see clearly as the regulators think about that. But also bear in mind, the next wave of things like ADCs, bispecifics, trispecifics, we're having very constructive conversations with the regulators in that space. So again, I think that's what's driving it. I'll perhaps get Christophe to comment on urban wastewater because actually I think there's as much an opportunity as a risk there, which is interesting. And then I'll pass to Remco. Christoph, do you want to talk about European wastewater?
Christophe Delenta
executiveSo about the European wastewater, I mean, if we think about the cost, I mean, today, it's extremely hard to understand exactly what will be the cost for pharmaceutical industry and the cosmetics. If you've seen the news from last Thursday on the 3rd of September, the general advocate has issued her opinion against the EPR scheme, which is the extended producer responsibility, which we're allocating the quaternary treatment costs to cosmetics and pharmaceutical industry. So today, we are in a good position, and we are waiting to see whether the European Court of Justice will follow the Advocate General and a new the EPR scheme.
Richard Saynor
executiveI mean also against the whole industry. So it's not aimed at Sandoz. And also bear in mind, as Remco discussed, in a sense, by -- into the 2030s, we become predominantly a biologics company, which it tends to be more value-driven rather than volume driven. So I think at the moment, it's philosophically, it's a volume tax. It's not a value tax. And as we become more and more of a value portfolio company, that exposure also shift. But I think to be fair, it's one thing that's a level playing field across the whole industry. But clearly, we're working hard to help regulators and government understand the implications of that. And we've never been in a such better position, right, since it started.
Remco Steenbergen
executivePerhaps first on the growth drivers and then Rebecca will add. So our growth is always our existing business plus the new launches, correct? And you can see also in '29, '30, there are significant launches, which are coming in. And of course, they contribute to the double-digit growth in the years thereafter. I'm sure Rebecca can be a little bit more specific. With regard to the margin improvement, we like to be very boringly consistent in the sense that SG&A, correct as a percentage of sales every year should benefit the margin. And as well on the gross margin, we have every year a job to do with the mix improvement and the procurement savings and the prices to make also some improvement there. So I don't see it's a significant step-up in one way or another. Of course, you can argue that in the 30s, particularly on the manufacturing, we will get some benefit. But also there, when you -- when we ramp up the sites, correct, this benefit when you come to a full leverage of the site and the site that will also take a little bit of time. So when we start ramping up in '29, it probably has some ramp costs in '29 and '30 and we're not full and as of 31 that will come in. But also then with scale, that will better multiply. But that's why we are quite confident that the 25% to 27% over a 5-year period should at least hit 30% by '35. Rebecca?
Rebecca Guntern
executiveYes. Maybe adding in terms of 2030 to 2035, I mean, you saw the numbers.
Richard Saynor
executiveWe can't see you. We can hear you.
Rebecca Guntern
executiveNo. Listen, we go from 30 products in 2030 to 70, so which means we're going to add 40 launches. And of course, not all the launches start by 2030. So you have a phasing up of those launches. We're seeing a huge LOE between 2030 and 2035 with you know the exam like KEYTRUDA and some of the bigger oncology launches, but also in immunology, and we will continuously look for partnered assets across this period. Fundamentally, the dynamics we monitor currently, right, and consistently in a sense, if we would see that competitive landscape is changing, this would, of course, be in favor of what we currently think the growth rate and the ambition is going to be. And we think conservatively in terms of pricing. So we believe we have a strong plan in place. We might see upside depending on competitive landscape.
Craig Marks
executiveWe'll take a few more, I think, before we close out. So just one from the webcast. So Joris has come back with -- and this is definitely for you, Remco. So you indicated that delivering the Bio 100 ambition requires additional investments in the range of USD 2 billion to USD 2.5 billion. Could you help us think about the expected timing and composition of that spend? Specifically, if I can say it, how should we think about the split between CapEx versus OpEx?
Remco Steenbergen
executiveOf course, we will not spend $2 billion to $2.5 billion in one single year. You can be short of that. So that will be equally spread over the coming 5 years. Most of that $2 billion to $2.5 billion, as I said before, is to be spent in development. So about, let's say, 2/3 of that and 1/3 is going in manufacturing. The manufacturing part clearly gets capitalized. On the development in the overall portfolio, there's also a part which gets capitalized, but that you have to see in the context that bio as part of the total DNR goes up. So relatively also our capitalization goes a bit up. So you can't only link that to the $2 billion to $2.5 billion.
Craig Marks
executiveI'm struggling to see the top. So do you want to take a pick at the top. Simon?
Simon Baker
analystSimon Baker from Rothschild & Co Redburn. Two quick ones. I'm conscious of the time. Can you just give us an update on where we are with interchangeability in the U.S.? How important is that to unlocking biosimilar penetration within the U.S.? And how successful has it been ex U.S. where it's more established? And then a quick one for Remco. Obviously, the COGS is sensitive to the proportion of group revenues, which are biosimilars. But how sensitive is COGS to the mix within biosimilars beyond ownership? So are there any meaningful differences we should think about between therapeutic areas, between size? Are these smaller opportunities, lower gross margin, higher gross margin about the same? Any sort of color you can give on the sensitivity of biosimilars themselves to the gross margin?
Richard Saynor
executiveKeren, something we've not talked about for a while, actually interchangeability.
Keren Haruvi
executiveIndeed. I would say, generally speaking, that it's getting less and less important. I think the FDA recognized that it should not be a decision-maker for the physicians, and it's not part of the label anymore. Congress is working to change the legislation around it. So there is a lot of support. It didn't happen yet, but we're optimistic. I would say from a commercial perspective, there is still people that believe that interchangeability is something different than what it is. The reality is just allowing the pharmacist to change the product if the prescription does not say a specific biosimilar. So in medical benefits, we don't see an impact, and we did -- and we never saw an impact. I would say in pharmacy benefit, the perception is that there is a benefit, but we were very successful with adalumab, and we got our interchangeability 1.5 years after we've been in the market. So I would say it's something that people consider becoming less and less important. And honestly, the other attributes of the product, the patient service and everything around the product are much more critical other than...
Richard Saynor
executiveI would say rest of world is relevant I mean it's not a conversation that we have anymore. Remco, I mean...
Remco Steenbergen
executiveYes. We approach it more from a margin perspective overall. And as I said before, biosimilars, which we fully develop ourselves have a gross margin, which is higher than the average. If we partner, it is lower, but also we have lower costs because we don't develop and we share the profitability. If you think about the different biosimilars, the larger and the smaller one of the cost of goods sold per unit, I don't think that's the real driver of the gross margin. The driver is really the discount, which -- and that depends on the competitive intensity. So we expect indeed that with smaller assets, we will have less competitive intensity, and we will have a higher margin, much less related to the cost of goods sold per unit.
Richard Saynor
executiveAnd also, I think bear in mind, if you take a drug like Omnitrope, it's 20 years old, it behaves like an originator product. No one is likely to ever develop. I could be wrong, but I can't see anyone ever developing a biosimilar to a drug like Omnitrope. And so in a sense, the terminal value on a product like that is very significant. And it's continuing. It's probably still one of our largest assets. It continues -- and I could say the same with a number of other biologics. So in a sense, they don't decay in the same way that small molecules do. They have much longevity. And then you don't -- it's much harder then for new competitors to come into those markets. So as we add more and more assets, you build this foundation of business that is highly accretive.
Craig Marks
executiveOkay. Before we go to the last question, and I hand over to Richard for final remarks, I'd just encourage you to have a look at the slides in your goody banks along with the chocolates because it's in the appendix. It does show that the full range of assets we're looking to target. So there's comprehensive pipeline slides in the back. And also, it shows a calendar of all of the events and the corporate access we're looking at over the next few weeks or so. Let's go to the last question. Let's go with that. Right in the center, I think in the center.
Urban Fritsche
analystUrban Fritsche From ZKB. So question to Keren and Christoph and Peter and the second one. So in the U.S., I mean, we have several favorable changing regulatory environment. But on the other hand, we have the very protective behavior of the originators. So a situation like Humira, is that something which is still possible to some extent, at least in the U.S.? Or is that history?
Keren Haruvi
executiveWell, I'm very optimistic. And I do think that there is a lot of opportunity. I think it's clearly that we are the solution for a lot of the challenges that we have in the health care system in the United States. I think still more policy is required, and we are working hard to provide it, but things like biosimilar first and other ideas that we have in mind. But we absolutely will continue to shape the market. I think also Humira, yes, it took time, more time than we want, but already 60% of the market without -- if you look without private label, 60% of the market is already biosimilars. So we're absolutely progressing.
Richard Saynor
executiveI mean, the patent reform, you're seeing great work there, PBM reform. The FTC is looking at the behavior of a number of the originators in the marketplace. So you're seeing a shift when 3 biologics in the U.S. cost more than all of the generics and biosimilars, which supply 90% of the patients, something is wrong. So I think there's a huge opportunity for that change. And to be fair, the administration, they see the huge disparity. So I think we're sitting on a position of opportunity with the pipeline that we have and the relationship that Keren and the team have built. So I think we're extremely optimistic.
Urban Fritsche
analystOkay. And then maybe to Christophe and Peter, I mean, you mentioned you are the leader in biosimilars in Europe, international. So you're also the one to go after. So in terms of competitors, what do you think where are competitors really picking at you, where are they trying to pick up? And how do you defend yourself?
Christophe Delenta
executiveThank you very much for the question. And indeed, we see -- and we have competition as well in Europe. And this has been the case forever, right? Now as I said before, Europe is a mix of different archetypes, right? We have tender, share of voice and substitution. The one that is the easiest to go for price sake is obviously the tender archetype, right? And we see competition coming our way in this tender archetype gaining share based on the volumes that they can gain. Our response is quite simple. The first thing is, as I said, Europe is 40 countries. It's 3 archetypes. We have a model that is built to be successful in all 3 archetypes. And when it comes to tender, obviously, cost of goods are important, supply reliability are important. And just to give you an example, aflibercept in the U.K., we were supposed to have many competitors. Today, we have 80% share, and we have been awarded as a backup supply -- national supply in the U.K. by the NHS, right? So it shows that it's not only the price that matters. It goes way beyond the price and we need to be good at all the different items rather than just the price.
Peter Stenico
executiveAnd maybe I take it international. International, we have a very selective play, right? We think on which are the markets we want to play in where we have a good commercial presence, which is 20 direct markets and then 30 markets where we have a distributor model. So in those 20 markets, which are very diverse among each other. I mean I mentioned Australia, Japan and Brazil as examples, we have really strong local customer intimacy and presence in order to be able to compete. The example I gave in Brazil with the PDP is an important one. We have that relationship, the experience, the portfolio and the breadth of the portfolio to succeed in that. But that's only one side of the coin, right? I think for international, what's really important -- so one side is the market share we're having and the competition. The other side, which is really important, is the overall biosimilar acceptance. In international, we are still a bit behind Europe in terms of biosimilar acceptance, biosimilar penetration, but that is changing now rapidly. We see a real shift in the acceptance of biosimilars in large markets like Australia, Brazil, especially also Japan. Japan is the third largest biologics market and has the lowest biosimilar -- or one of the lowest biosimilar penetration today. This will change, thanks to a new law that is being implemented, which will push double penetration over the next years. So I think apart from having a discussion on shares against competitors, it's also about really providing more access for patients and reaching more patients by better biosimilar penetration in international.
Richard Saynor
executiveAnd also, I go back to Page 33 on Rebecca slide, the biosimilar void. I think it's 2 parts. going back to what I just said, do you think a lot of the local competitors are going to develop a biosimilar to human growth hormone? No. So in a sense, there's an opportunity for that to continue to grow. You're sitting here with a huge number of assets coming off LOE. Of course, some of them will get competition, but do I expect them -- so I think it's this unique combination. And I think then as we move perhaps to a close, it's a nice segue to say what's unique about Sandoz? We've had this global scale. We have pedigree in terms of delivery. We've consistently executed across that pipeline. We're now sitting with a golden decade that the originator industry sees as this patent cliff. We see as our patent opportunity. We're investing. We're vertically integrated, and we have a commercial scale. So I think in a sense, this is now an execution story. It's an incredibly exciting time. Hopefully, we've given you a flavor of what we want to do over the next few years. I'm incredibly proud of the colleagues and the team that are here and the 23,000 people around the world -- and thank you again for your questions. Happy to have a drink in the corner, no doubt we'll have to continue the conversation. I'm here as the management team are here. So happy to continue the conversation over a glass of wine or a cold beer. And Remco, team, Gilbert, our colleagues, thank you so much, and thank you all of you for your active participation and questions.
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