Fresenius Aktie

Good afternoon, and welcome to the conference call of Fresenius Investor Relations, which is now starting. Now I hand you over to Nick Stone, Head of Investor Relations.

Thank you, [indiscernible]. Hello, everyone. Welcome to our half year and Q2 '26 Earnings Call and Webcast. The presentation was emailed on distribution last night following the [indiscernible] announcement and is available on fresenius.com. On Slide 2 of the presentation, you will find the usual safe harbor statement, unless stated otherwise, will comment on our performance using Constant Exchange Rates or CER.

[indiscernible] from a position of operational strength with another excellent quarter of greater full year guidance and clear evidence of the structural step up in earnings quality that we've been building towards. I'm very pleased to be joined by Michael Sen, who will take you through the results and what they mean for the continued delivery for future for Fresenius. As usual, the call will last approximately 1 hour, with the presentation taken around 30 minutes with the remaining time to your questions. To give everyone a chance to participate, please limit your questions to 1 to 2. We can always come back for a second round, if needed. And with that, I'll hand over to Michael to explain how today's results reflect a stronger, higher-quality prevalence with greater strategic flexibility.

Well, you said it all. Thank you, Nick, and welcome to everyone joining us today. I'm very pleased to report another excellent quarter for Fresenius. We delivered strong operating performance, high-quality growth continued earnings progression, improved margin expansion and higher returns. From this position of operational strength, we are raising our full year core EPS growth guidance to between 10% and 15% at constant currency.

Sara and I will take you through the key operational and financial highlights in a moment, but let me start with the main message from the quarter. Q2 is another clear proof point that future Fresenius is delivering. We are converting operational momentum into earnings growth, higher returns and stronger financial and strategic flexibility. Importantly, this is not simply about 1 strong quarter. It reflects the consistency of execution we've built across the group, and this is important, the structurally higher quality profile of Fresenius today.

Compared with 2022, Fresenius now has a stronger earnings base and more resilient cash generation profile. [indiscernible] growth vectors are scaling and contributing more visibility to earnings, while Helios continues to demonstrate resilience in a changing regulatory environment. Together, this is improving the quality and durability of our performance. This is exactly what our rejuvenated agenda was designed to achieve a more focused Fresenius with a higher-quality business mix, disciplined capital allocation and increasing exposure to innovation-led growth.

When we talk about a structural step up, this is visible in measurable outcomes, double-digit EBIT and core EPS growth, improving margins, rising returns and leverage at the lower end of our target corridor. So the message today is clear. Fresenius is stronger, more focused and better position than it was at the start of our transformation. We are delivering better outcomes for patients, creating long-term value for shareholders, and gaining greater strategic flexibility for the future.

Our second quarter performance shows how operational momentum is translating into financial results. Core EP has increased by 14% at constant currency, significantly ahead of top line growth and reflecting continued earnings across both Kabi and Helios. EBIT increased 10% at constant currency while group EBIT margin improved by 60 basis points to 12.3%. Our return profile continued to strengthen with ROIC reaching approximately 7%, around 200 basis points above the reset level in 2022 when we started the transformation journey.

At Kabi, our growth vectors delivered 12% organic growth and reached a margin of nearly 18%, demonstrating that scale is increasingly translating into profitability. What we started in 2021 with Vision 2026 is turning Kabi into a higher-quality health care business with a more visible innovation-led and stronger future earnings contribution. Importantly, Fresenius now has multiple platforms delivering biopharma, nutrition and met, contributing growth scale and margin improvement simultaneously. Together, these platforms now represent a meaningful and increasingly important contributor to earnings growth and future value creation.

At Helios, margin remained firmly within the structural target range at 10.6%, demonstrating the resilience of our care provision platform, despite continued external uncertainty beyond health care regulations. This is also a function of our systems being the market leader. Against this broad-based performance, we decided to raise our full year core EPS growth guidance. This upgrade reflects the breadth of the performance and the improved earnings profile of Fresenius today with a future Fresenius at work.

The quarter shows clear operating leverage across the group and strengthens our confidence in the full year outlook across Fresenius we are turning disciplined execution into sustainable value creation. Now let's move to our businesses. Let's start with Fresenius Kabi. We continue to strengthen our position as an increasingly innovation-driven health care company moving into higher-margin growth areas while expanding our pipeline capabilities and future growth opportunities. A key enabler of our progress is the increasing strength and the domain expertise of our business leaders a core pillar of rejuvenate.

In France, we further strengthened our pipeline through 7 new in-licensing agreements signed during the first half of this year. enhancing our future product portfolio. Let me briefly address the recent routine FDA inspection at our U.S. manufacturing sites, while our Grand Island and Wilson plants received voluntary action indicated a VAI status, our Melrose Park site has received official action indicated status. We are working closely and constructively with the FDA to address the observations and implement the necessary corrective actions.

The facility remains fully operational and based on our current assessment, we do not currently expect any material impact on production, supply or our full year financial performance. In biopharma, we are increasingly demonstrating what investors have been looking for from Fresenius. A repeatable, scalable growth platform with strong commercial performance successful launches, expanding market shares and rising profitability across multiple molecules and geographies.

And this quarter, we achieved another important milestone with the U.S. and EU regulatory submission acceptance of vedolizumab, a biosimilar candidate for the treatment of moderate to severe Ulcerative Colitis or Crohn's disease, we now expect a regulatory decision next year. In addition, this week's FDA approval of our rituximab biosimilars further expands our U.S. biopharma portfolio. These development support our long-term growth ambitions. Commercially, performance in Q2 was driven by continued momentum from our in-market molecules, particularly tag-in and the strong pickup of our denosumab disimilar following the launches last year.

This reflects the intense effort of SunGen and his leadership team around the world, particularly in the U.S. In Nutrition, we are accelerating our focus on innovation and evolving our portfolio toward higher-value solutions. We launched the Prisma range in Europe a new ready-to-use free chamber bag for nemonatal and pediatric parenteral nutrition supporting some of the most vulnerable patient populations. We also opened our new Nutrition innovation center at our headquarters, strengthening our capabilities and supporting the development of next-generation therapies.

Congratulations to Mark, Sebastian and the team on this import on their accordant step for this nutrition business. In MedTech, we accelerated the commercial rollout of our Ionix Smart comp in the U.S., delivering strong execution with installations at leading health care providers, including Mayo Clinic and SSM Health. At the same time, we enhanced the capabilities of our products and esthetic depth monitor a noninvasive brain activity monitoring solution with improved WiFi connectivity and system integration capabilities, further expanding its value proposition and commercial potential.

Thanks to [ Mathis ], who hit the ground running and the Medtech team for building a more differentiated platform for growth. So you see strong team, great outcome. Now let's turn to our biopharma business. As our fastest-growing platform, biopharma is playing an increasingly important strategic role within Kabi and Fresenius. The strong momentum we continue to see across all major regions further validates our investments and reinforces our confidence in the significant long-term growth opportunity ahead. This progress is clearly reflected across our in-market portfolio.

Tim, our totilithmum biosimilar continues to gain market share sequentially reaching 44% in the top 5 EU countries and 30% in the U.S., highlighting clearly our commercial strength and capabilities. [indiscernible] biosimilar is now launched in 18 markets worldwide, further expanding our global footprint. With Bomintra, we have established a leadership position in several key European markets and reached a market share of 11% across the EU 5. We have also seen encouraging early uptake in the U.S. despite a competitive market environment, this represents another successful launch and demonstrates that our biopharma platform is gaining scale and delivering repeatable launch success across multiple molecules.

Turning to our care provision platform, Helios. In Germany, the approval of the Gicsa Stabilization Act provides a constructive framework now for continued reimbursement growth. I will share our perspective on this one in a moment. Across Helios, we continue to invest in innovation to improve patient outcomes and to strengthen our clinical leadership. At our [ Light See Heart Center ], a 15-year research program has demonstrated how enhanced recovery protocols and innovation can meaningfully improve patient outcomes after cat cardiac surgery.

In Spain, [indiscernible] continues to strengthen its position as a leading research platform with almost 1,500 active clinical trials and more than 400 new studies initiated in 2025. We also established a new chair for robotic surgery together with [indiscernible] Carlos, reinforcing our commitment to research and education in advanced surgical technologies and helping generate evidence on improved outcomes, patient experience and health care efficiency, all embedded with artificial intelligence. Quironsalud continues to invest in innovative technology that delivers measurable value for patients. Under now Christian Pablo's leadership, Helios will continue to advance our clinical leadership and innovation agenda. Now let's stay with TVs for a moment and provide our perspective on the GigaPower Stabilization Act and its implications for our German hospital business in 2027.

We know that investors continue to focus on the future of reimbursement of the reimbursement environment in Germany. The key message today is straightforward. Our outlook for our hospital business remains unchanged. The improved Act provides a constructive framework for continued reimbursement growth and is more favorable than the earlier draft [indiscernible]. While the temporary surcharge expires at the end of October, we expect the impact to be substantially mitigated through higher reimbursement rates, continued volume development operational improvements and accelerated cost and efficiency measures. As a result, we remain committed to Helios' structural EBIT margin ambition of 10% to 12% and continue to expect EBIT growth in 2027.

Through Christian's leadership, we will continue to improve the operational performance of our care provision platform. He and his team are fully committed. The first half of the year confirms that Fresenius is executing consistently across the group. Our growth vectors are scaling profitably Biopharma is becoming a more significant earnings contributor and Helios continues to demonstrate resilience and operating leverage. These developments give us confidence to raise our full year EPS growth guidance and reinforce our conviction in the medium-term trajectory of the businesses. And with that, I'm happy to turn it over to Sara.

Thank you, Michael, and welcome to everyone joining today's call. Q2 was an outstanding quarter for Fresenius. The key message is clear. We are consistently converting operational momentum into earnings growth, reflecting the structural step-up in our businesses. Organic revenue increased by 6%, also a nice quarter-over-quarter acceleration. This converted into 10% constant currency EBIT growth supported by strong operating leverage and continued productivity gains across the businesses.

EBIT margin expanded by 60 basis points year-on-year to an excellent 12.3% and with both Kabi and Helios contributing to this improvement. The tax rate of 24.8% was lower year-on-year and in line with our full year expectations. Our significant deleveraging in recent years continued to benefit the interest line, supporting 14% core EPS growth at constant currency. This underscores our consistent execution and durable earnings momentum. Operating cash flow was strong, and I will discuss this in more detail shortly.

Finally, leverage remained stable at 2.6x net debt-to-EBITDA despite the dividend payment during the quarter. Turning to Fresenius Kabi. Q2 was a strong proof point that future Fresenius is delivering durable results. Organic revenue increased by 7% at the upper end of the structural growth band. This was driven by the continued scaling of the growth vectors with a 12% organic revenue growth. Within the both sectors, biopharma continued its momentum with organic revenue growth of 38% in the quarter, demonstrating the increasing importance of biosimilars as sustainable growth engine for Kabi and Fresenius.

In Medtech, organic revenue increased by a strong 11%, reflecting Ionix large volume pump installations at several leading hospital system providers. This brings organic growth to 7% in the first half of 2016, which is also a reasonable assumption for the second half of the year. In Nutrition, organic revenue increased by 5%, driven by all regions outside of APAC, was still partly impacted by the overall soft economic environment in China and the remaining hero volume-based procurement effect. This effect was fully annualized next quarter.

Pharma organic revenue increased by 1%, with strong commercial execution outside the U.S. and good volume growth partially compensated by pricing pressure in the U.S. This strong top line led to an excellent 17% EBIT margin at Kabi, reflecting strong operating performance and further productivity gains. Both sectors delivered a margin of 17.9%, up 360 basis points year-on-year and for the first time, within our upgraded structural margin band. As Q2 benefited from some favorable mix, including milestones and phasing, the first half margin remains the better proxy for the current underlying level. The pharma EBIT margin this quarter stood at 18.9% and reflected some costs associated with manufacturing adjustments.

Year-to-date, the EBIT margin was around 20% and which remains a reasonable assumption for the second half of the year. Turning to Elo. Organic revenue increased by 5%, with a strong EBIT margin of 10.6% and fully in line with our structural ambition for the business. EOS Germany delivered 6% organic revenue growth, driven by positive pricing and inpatient emission growth partly offset by case mix development. EBIT increased 16% at constant currency with the EBIT margin up 80 basis points to 8.3% and supported by continued cost management and the searcher for publicly insured patients.

At Helios Spain, organic revenue increased by 3%, supported by increased activity levels, positive pricing and continued growth in our occupational risk prevention centers. reduced activity levels in Colombia weigh on top line growth. increased 5% at constant currency with a 14% EBIT margin, reflecting continued positive operating leverage. Q2 operating cash flow was strong at EUR 344 million, driven by excellent cash conversion, particularly at Kabi. On a last 12-month basis, operating cash flow from continuing operations reached EUR 2.8 billion, more than EUR 500 million above the prior year level. It demonstrates the focus and structural step-up in cash generation.

Free cash flow for the last 12 months amounted to EUR 1.6 billion, this includes the dividend payment made in Q2 and around EUR 290 million of proceeds from the pro rata sale alongside Fresenius Medical Care share buyback. Cash conversion remains excellent with the last 12 months cash converted rate at 1.2, once again, above 1. Stepping back from the quarterly numbers, further reinforces a key message. Fresenius performance is now translating into stronger earnings, higher returns and a stronger balance sheet leading to a structural step-up in our financial metrics. ROIC reached 6.9% in Q2, an improvement of around 200 basis points since we launched reset in 2022. It's the highest level achieved this decade.

Our CapEx assumption of around 5.5% of revenue reflects targeted investments in future growth under rejuvenate while maintaining our discipline on capital allocation. We remain firmly committed to a strong balance sheet and our investment-grade credit rating. Our leverage target corridor of 2.5x to 3x net debt to EBITDA supports that commitment. The successful EUR 1 billion bond issuance in early July demonstrates our strong access to capital markets and the proactive refinancing approach.

Strong earnings, robust cash conversion and a strong balance sheet gives us the strategic flexibility to invest in profitable growth. Any optionality related to our Fresenius Medical Care stake is incremental to this position. We will continue to invest with a clear focus on returns. We remain committed to our 6% to 8% ROIC ambition, and we expect further improvement over the mid- to long term as we strengthen our growth sectors. Let me conclude with our guidance and outlook. Based on strong broad-based performance and the excellent contribution from our growth vectors, we are increasing full year core EPS growth guidance at constant currency from 5% to 10% to now 10% to 15%.

The updated guidance reflects the strong first half delivery and our current view on second half phasing. For Kabi's EBIT margin, we now expect to be at the upper end of the 16.5% to 17% range. We are also updating our interest expense assumption, which we now anticipate being slightly below the prior year. If the exchange rates remained at the spot rate of 30th of June, we would anticipate a slight positive impact of less than 1% on reported revenue, EBIT and net income for the full year. Looking ahead to the second half, the usual detailed phasing assumptions are included in the appendix. But let me highlight 3 points.

First, at Kabi, we expect to see consistent top line development and the cat effect fully annualizing from Q3 onwards. Second, at Helios, we expect the usual Q3 seasonality in spend. Q4 faces a tough comparison, particularly in Spain, in Germany, remember the surcharge for publicly insured patients run from November 25 to October 26. And third, a more technical comment share price performance after 30th of June may create potential catch-up effects in long-term incentive time accounting as we move through the year.

Overall, we see a [indiscernible] change in performance. Q2 is another proof point and reinforces the strength and consistency of our execution. We are raising core EPS guidance on the back of a strong first half delivery. And with that, I hand it back to Michael.

Yes. Thanks, Sara. So rejuvenate is translating into measurable operating and financial outcomes, stronger growth higher margins, improved returns and a healthier balance sheet. Investors rightly want continued evidence, clarity and consistency, and our objective remains straightforward. To keep delivering quarter after quarter and create sustainable long-term shareholder value. Over the last few years, Fresenius is fundamentally repositioned itself around 3 powerful health care platforms, biopharma, med tech and care provision. We have moved beyond managing individual businesses and/or dispersed geographies -- we built focused platforms capable of capturing long-term structural growth opportunities. Much of our growth acceleration and profitability improvement has been driven by the growth vectors. We have pivoted. These businesses are no longer emerging opportunities. They are becoming material contributors to Fresenius' growth and margin profile.

In biopharma, we have demonstrated our ability to successfully build derisk and scale the platform. We have established a strong foundation and management team delivered proof points and created a business that is positioned to participate in the next generation of biologic therapies. Looking ahead, our ambition is clear to double sales and reach an EBIT margin of around 20% by 2030. We Exceeding our ambitions will require further R&D investment in the early-stage pipeline and potential business development.

In Nutrition, we're accelerating growth through differentiated products and innovation that address evolving patient needs in med tech, innovative solutions such as IVX and the plasma nomogram bring differentiated technology to customers and are strengthening our position in attractive expanding markets. Put simply, our portfolio is increasingly aligned with higher growth areas of health care. Importantly, we are not managing these businesses around today's products only.

We are positioning Fresenius to benefit from secular growth trends and to proactively address paradigm shifts, including next-generation modalities such as antibody drug on gets, ADCs, bispecifics and other advanced technologies. At the same time, health care is becoming increasingly consumer-driven, with patients playing a more active role in treatment, prevention and health care choices. The patient is gaining agency across our platforms, we are aligning our portfolio with where health care demand is moving, not where it has been. We are also broadening our access to innovation beyond existing businesses.

Our recently announced Fresenius Venture initiative strengthens our health care ecosystem, expands our access to emerging technologies and business models and create additional avenues for long-term growth. Our capital allocation priorities remain clear: first and foremost, we continue to invest in the business, strengthening the growth vectors, which can generate sustainable, profitable growth and create long-term value. At the same time, we have significantly enhanced our financial and strategic flexibility with leverage reduced to approximately 2.6x net debt to EBITDA with additional optionality from the value embedded in our F&E stake.

We have earned the right to play by transforming Fresenius into a more focused company with stronger platforms, deeper expertise and a healthier balance sheet. We are now reinforcing our ability to win, not only in today's health care but in tomorrow's by building scale in attractive health care markets and investing for the next decade. And with that, we're going to take your questions.

[Operator Instructions]. Over to you, Nick for the first question.

Can we take the first question, please, from Hugo BNP Paribas.

Just a quick question on the updated upgraded EPS growth guidance. That implies a wide range of outcome for EPS growth in H2 from plus 5% to plus 15%. Can you maybe discuss phasing in Q3 and in Q4 and whether you see either Q3 or Q4 coming below or above that 5%, 15% range? And given you've we've seen performance nicely compounding since the beginning of the year to what extent you see EPS growth carrying into 2027?

And then my second question, just a quick clarification. Michael, you mentioned that you continue to expect EBIT growth and EBIT margin within the 10% to 12% range for Helios in 2027. Am I right to also understand that you expect Helios margin to progress year-on-year in 2027. Thank you.

Well, thanks. I could make it short and say '27, we'll get there when we get there. We didn't even have the budget. I think we gave you a very directional clear data points on how to think about '27, and that is against the whole discussion we had in the last couple of months. But it seems to be a nice maybe Sara put some light on the Q3, Q4 EPS development for the full year. And therefore, for the half, it should be already clear.

Yes. Happy to do so. And look, I think. As you know, not a huge kind of quarter-on-quarter because there are always some phasing in between. And as I look at sometimes I much more prefer to look at H1. And I think you read that or you listened to that in the comments I just made. And so if I look for the second half, I -- there are some distinct quarter descriptions. And I think the seasonality in Spain certainly want to pick up in -- and outside that, if I go now for Kabi, we will see consistent or we expect to see consistent top line development as we have seen throughout the first half of the year. You will see the two effect fully annualizing. You will see more launches and ramp up to come. If you look at Helios, I already touched on Quironsalud and I think it's fair on Helios, the Q4, but that also moves for Kabi.

Q4 for us was a very strong quarter last year. There was a lot of stories nicely aligned on the Q4. And so Q4 will be a tough comp on a year-over-year basis. However, for me, it's more important to see the momentum we have operationally in the businesses currently running. And I think the first half gives us a really nice kind of optimistic perspective for the full year, which is why we upgraded the core EPS guidance.

Can we take the next question from Hassan please?

A couple, please. Firstly, a follow-up on guidance. Just a high-level question, Michael. Can you talk about what has positively surprised you the most in the first half to allow you to raise guidance in substantial way. What are the key assumptions for the top end of guidance? I appreciate the strong top line at Kabi, but on an unchanged margin assumption for the year, should we think this is more of a floor. And then secondly, it does continue to look like the Fresenius and Fresenius Medical Care performance is continuing to diverge, do you have any updated thoughts on your investment post the second quarter and the revenue dynamics and really better utilizing the capital and reinvesting it into your growth businesses, which are doing better than expectations yet again.

Thank you, Hassan. Let's start with the second one. I mean vis-a-vis our stance towards FMC, nothing has changed. This is just investment, nothing else. Don't manage that one operationally. It's not in our core numbers, giant. It's an investment. And obviously, like any investor, we follow how the investment is doing. We also heard, let's say, the operational deviation in the last quarter. So if this is operational, there's also things to be done. But you heard Sara and myself also talk that it is more or less a cash and cash equivalent.

But that is always a function as to what is the value on the other side, but also a function and there maybe our tone is becoming more confident because I always said it depends on the maturity also of our company as to when and how we deploy capital. We started Rejuvenate 2 years ago. going into innovation-led growth, starting more on the organic front investing in R&D, starting investing into in-licensing and the big message today is this is a structural shift. This is a step up. The growth vectors, the platforms are scaling by scaling contributing, why are they contributing because they are leading in the marketplace. They are picking up share.

They have been very well recepted by customers. And therefore, whenever we see opportunities to scale that even more, that was almost my last chart. Then we have, let's say, several routes to do that. Obviously, we will be disciplined, but the balance sheet alone allows for things to do, but that is not the only route. And then we need to see what are ticket sizes and the like. I think on the outlook, Sara alluded to the Look, at the end of the day, what is really encouraging is that broad-based performance across, in this case, all 6 businesses.

And even if I take the pharma business, then I take that first half, and then it's also completely in line. We were actually not how should I say, surprised in a sense that we didn't expect things to happen. But at the beginning of the year, when we were discussing and you guys were telling us whether we are too conservative on guidance or not, we told you a few things need to happen. And if they happen, they will contribute. But we also said it is predicated on sales, i.e., we always said, this is a volume gain this year. And that volume game is working. If you look at biopharma, the 38% to at the beginning of the year that there will be competitors coming into the market in this calendar year, which they are we have a backyard to defend, but it's not only the backyard to defend, we can play offense.

In the U.K., we have 75% market share. EU5, we mentioned the market share. What is then unfolding very nicely is denosumab. Also here, we told you that we have a differentiated product in the oncology space, primarily on Bomintra with a prefilled syringe. Now we may have that, but does the customer also buy takes 2 to tango. Obviously, we see we are tanking. That's why these things are working -- but a couple of months ago, you always make a weighted average kind of thing. And here, many things have worked. And the momentum made us materially shift the to 10% to 15%. And now to [indiscernible], it's still 500 basis points between 10 and 15, but it's also a shift to the upper end of the other guidance.

So in there, it is again a function and Sara alluded to already Q4, maybe tougher comps. But it is also a question of the dynamics of the market. Currently, we see this thing is going on engines. By the same token, we may also decide maybe to also invest into even future growth, and this is what we're balancing.

can we take our next question from [indiscernible].

Thanks. So maybe just, Michael, on biopharma, like a nice sequential improvement there. It's really good to see. But I'm just thinking tie-ins obviously been a great driver of growth and kind of core to the franchise for a while now. How diversified do you think this is going to be in 12 months' time when you think of denosumab vedolizumab. And you've got -- have you got a sense as to how much more diverse bond you could be maybe in sales split? And just following up on that then, given the talk around where balance sheet leverage is -- could you be more maybe aggressive in the right word, but could you be a bit more frequent in terms of some of the deals you do to really booked what's a super exciting portfolio?

Goodness, Someone is listening. Look, on the bio, we probably have, let's say, a plan or a makeup even for beyond next year. That's why we came to this -- what was the capital market education exercise in December, where there must have been some cases for us telling you we're going to double in revenue and going to go to the 20%. So -- we now currently have 11 products on 8 molecules in the market. Metui is coming. We now can commercialize this in the U.S. Now again, it's the same kind of thing. How is the pickup? How is the market responding then others are on the regulatory approval. We'll see when they come, how long we can ride also, let's say, a very strong market position of Tien as to when do we believe there is peak sales, which we will not tell you, obviously.

But it is encouraging that the first couple of months of densa is really, really, really picking up. And in the U.S., we are actually only at the beginning, and this is already a market where more people are in the various segments. So we're going to build on that one. And yes, this was my last message. And even when I said Q4, we're not going to gear that whether we're going to get to the upper end of the guidance. We're going to gear that what is good for the business and how do we invest? And yes, we have means now to maybe go beyond what we have been saying, but that is also a question of opportunities.

Can we take our next question from Oliver Reinberg from Olivier Kepler, please.

Also two from my side. First, thanks very much for the color on the margin band for Helios this was reiterated. I just want to discuss Spain a bit. If we look at the margin performance of Spain over the last years, there hasn't been much progress we are starting even below the pre-pandemic level. I fully appreciate there has been many moving parts, but I just wanted to get your understanding of the confidence of margin improvement potential in Spain. And is it fair to assume that the margin improvement at Gileus, over the next, say, 2 or 3 years is more gates to Spain than for Germany? That would be question number one.

And secondly, on this OAI status at Neves Park, any chance to get a bit of more color what that means? I know that you talked about no major financial impact in 2026. Does it also apply for 2027? And is there a certain risk that this may impair your ability to launch your products?

Let me -- let me give you some color on Helios and more specifically on Spain. I think -- I mean, look, we delivered a 14% margin in Q4. I think that's a very strong margin overall. And I think we have all been very satisfied with the margins have contributed and printed very consistently over the last quarters. What we said on the Capital Markets Day is that on the hospital side, and now I'm more on the hospital in general, that includes Spain and Germany, it's a 4% to 6% top line growth and that we will grow EBIT at that level or slightly above that.

But that the margin potential is not like with the both factories where we do see that upside where we do see that next lag. It is more making sure that those 2 businesses run as resilient and stable as they are. And as such, I like and appreciate the stability and the level at which the Spanish colleagues are pushing their margin through the quarters. So also to your question on the 10% to 12%, which is and remains our kind of Fresenius framework margin ambition. You see where Germany stands today. You, I think, have seen the bridge we work through. I think that gives you an indication to where the medium-term potential could line.

And maybe to add, the way we have always been portraying our businesses, the care delivery, but also the pharma business, which we and now others also call base business. These are very resilient, robust, predictable businesses. These businesses are not geared for internal margin expansion. They are more geared towards -- they need to have the highest margin in the sector because they are market leader, the earnings if they grow organically, will thereby grow automatically, if the margin is stable and you grow, then earnings will grow, earnings will equal cash earnings as that one gives you the stability in the balance sheet for them, the other growth vectors to really scale. That is the logic of that one.

And maybe on the OAI, Look, as I said in my script, First of all, we know that many FDA inspectors are out in the sector. There's a backlog to be worked after COVID. So many companies are getting visits. We have had that OAI status, which means there is work to do. There's upgrades to be done, which we, by the way, also welcome because it gives us an opportunity to embed new technology when it comes to automation, digitization using data for predictive decision factory shop floor because that reduces the, let's say, aero probability of human errors.

But what is more important is that we are broadly based in the U.S. We have a manufacturing network in the U.S. So if one factory with a few lines has some or we can still play within the network. And that's why for now, we said 26%. There is no impact to be expected '27. It's the same with any other business. This has nothing to do with we need to do our budget first, and then we know what the numbers in total are. The third thing I would want to mention that this is important. This is not the Fresenius of a couple of years ago, which is largely predicated to generics in the U.S. generics plays a big role, and that's why we said we still have a manufacturing network for playing with. We have solutions now in the U.S. with Wilson picking up.

I didn't mention it in the speech, but we are still picking up market share here, we have a nutrition business in the U.S., which has been growing very nicely, and we want to again see launches in Q4 in the U.S. And we have the biopharma business. So the makeup is a totally different one to put it into perspective.

Can we take the next question, please, from Veronika from Citi.

I'm going to keep it to two as well. The first one is on the biosimilars business and tell me if my math is wrong, but looking at the performance in Q2, it does seem to me like we are fast approaching the midterm 20% margin target in that business. Just curious if you can sort of talk to whether my math is correct and how you feel about the from here and maybe just the balance that you see for investments versus margin accretion on a go-forward basis. That would be my first question.

And then my second question is on the really impressive growth rate in med tech and whether you feel that, that double-digit growth is durable? Or is there some phasing here that we need to consider through the remainder of the year?

You want to take that?

Yes, Veronica. So on Medtech, I think I already alluded to in my speech where the medtech growth in Q2 was nicely driven by substantial installations around the Avenixpump. And if I look at the full year of 2026, I think that the first half growth number is a better kind of approximation for what is ahead of us for the rest of the year. But I think what it shows you, and let me readers that is what the vet is doing. And it's the installation but then it continues, right? It's a continuous business and a continued revenue stream. And so it's really nice to see those installations happening in driving.

Yes. And even if you take what you Sara just said the first half, this is an impressive number. this is 7.2%. So if they can get to the 7.2% in the second half, which again means selling a few conus if you saw is and set and everything and keep installing the pump. But what you see with those two examples, slowly but steadily it's shining through the numbers, what our strategy is. Having that smart pump, great customer reception now doing the job on the installation and building out the installed base.

Over the course of the next quarters and hopefully years we will then report to you how the installed base is growing because the installed base is then the precursor for the recurring revenue offset and software. By the same token, we're going to work on bringing down the cost per pump. And I think IR also spread the news from recently scientific paper where they were comparing infusion pumps across the board, across the market and Ionix really stood out because it reduces the cognitive workload of of nurses and reduces the era. Now to your point of biosimilars, well, this has been an extraordinary great quarter with a 38% growth. But in absolute terms, Q3 and Q4, they need to deliver.

And even in absolute terms, we may have to step up, which we see good momentum with the molecules we have in the market. As it stands -- it is out in the open, what we said, doubling the revenue and getting to the 20% margin. But what I also said coming to more Graham's question is we also need to think beyond. So then that means thinking about what drives value, and that is obviously a function of pipeline of maybe further investments into capacity and maybe having another molecule in an adjacent therapeutic area like with [indiscernible] it is ophthalmology. So we will also talk about investment. This is not a margin maxing game for the next 3 years, and then we get to 22% margin and then go home. This is more or less what comes beyond and how do we create sustainable value until 2035.

Can we take the next question, please, from [indiscernible].

Just one left for me, please. And just end on pharma, format a dip in margins in Q2 on manufacturing adjustments. Just wanted to clarify, is this related to the Melrose Park situation? And maybe you could keep on what's going on there? And how should we think of margins from here?

Yes. Happy to take that. Look, I think taking the first -- the second piece first. If you think about margins, I would focus again on the first half. And that is what I would look for if I go into the second half and look at the sustainability of the Pharma margins throughout the year. I think we made that comment on Q2. I mean it's -- as Michael just said, we have capital manufacturing network. And in Q2, we had some kind of smaller manufacturing adjustments, but that was on the European manufacturing site has nothing to do with regulatory topics. But with more demand-driven adjustment in one of the lines.

Can we take our next question, please, from Ollie Metzger from Oddo, please.

Yes. First one is a clarification because you said for FY '20, you expect EBIT growth at Helios -- is -- would you say the same also for Germany in isolation? Second question is on farmers. So you added some 7 molecules in the in-licensing deals. So first part, can you remind us about your overall pipeline farmer. And second, when the 7 additional molecules are expected to be commercially relevant.

Yes, commercially relevant they're going to be in the next coming years. This is the in-lice thing we set for this year, I think roughly a double-digit -- low double-digit number on molecules. We launched a little less than the year before. By the way, in Q2, we didn't launch in the U.S. We didn't launch any molecule, which will come now in Q3 and Q4, which will support Q3 and Q4 in pharma. That's why as Sara said, the proxy is take the first half and take a rule for the second half on pharma. And only on look on Helios, everything has been set. This is a sector -- we have sector margin bands. This is a company to be managed with all assets and this is the outcome.

[indiscernible] I'm conscious of the fact we've got about 3 minutes left. So if I can ask the remaining analysts to keep their questions short, we'll try and do the same trying to get a thought on within an hour. So James, if we [indiscernible] come objectives, please.

Two if I can, please. Firstly, you highlighted on returns, obviously, there's been 5 quarters of improvement. And you're now at the midpoint of that 6% to 8% target range and now at the low end of your leverage range. So you talk about improvements over the mid to long term, but can you describe what the business needs to look like to be doing 8%? Because the reality is hospitals are capital intensive, which elects a drag to what you can achieve in Kabi and you're making other investments. So when would there be a natural ceiling in then actually have to prioritize returns. And I've got 1 quick follow-up, if I can.

Well, not sure whether I would follow your assumption. Yes, hospitals are capital intense, but they also have an operating contribution because the operating cost is mostly personnel costs and the like. And by the way, there are also other funding mechanisms, which we also talked about funds in Germany, how you can help on investing and CapEx. So taking the entire portfolio as such. This is the ROIC bandwidth. And don't forget that we also disclose without the goodwill. I think this is then what you see as the operational improvement. So we don't see anybody holding back the other one in -- I mean, look at for the first half CapEx to depreciation, I think this is a, I think, even below 70% or something. So for a 6% growth company, there's a log room.

Yes. A second one is just the -- so the 11.5% group margin. I mean mathematically can be delivered at the lower end of the Helios and the Kabi guidance. So I guess with raising Kabi to the upper end, so just curious rightly that unchanged and not perhaps say 11.5% to 12%, given you have a 0.5 point range for Kabi. So are there any higher corporate costs and perhaps specified a reason for the higher EPS guidance case I missed it.

Yes, it's very easy because we don't manage like that. We manage from business all the way to what then people consider the bottom line. which is the EPS growth. The EBIT corporate margin was just as reference point to help you guys because we went to core EPS guidance here for the first time. It is very clear. The business happens transactional in the market, in the business. This is why we then have margin bands for the businesses to help you model that 1 and to understand how we manage. And then on top, we manage the entire company, and that's the bottom line. Anything in between is random. I can shift corporate costs from left to right, from up to down, but view it as a kind of a floor and then we're going to get there.

We will take the next question from Aisyha, Morgan Stanley, please.

I can be quick. So the question was just on China. Just wondering, as you annualize the key to VBP headwinds this quarter, how do you feel about the risk of potential VBP in the remainder of your nutrition portfolio in China? And maybe equally how did your China Nutrition business ex Kito develop in the quarter?

Well, the Q3 will be in the first clean next quarter, there was some spillover last year going into Q2 because those who want the tender couldn't deliver. So we deliver it. And so Q3 will be the first kind of very clean quarter. On China, everything remains what we said China is important and big as it is as in the market, also in the mid- to long term, doesn't move the needle for us in the entire group. We do not expect growth in China out of many reasons. The volume-based tendering is there to stay.

I said in the last call, they are even making it volume-based tendering 2.0 that there is no arbitration between or you kind of arbitrage between national and regional there is, again, budgetary constraints from the hospital. They call it yellow lining. But we are not dependent on that 1 than got like other companies who got their performance moved by China. So on Nutrition, we expect growth in China, if at all, at in 2027 with out-of-pocket payment products. This is where we are banking on in China to get away from the budgetary constraints segments, which are out of pocket. So China flattish development for the second half.

Two questions to go. So Anna, Bank of America over to you, please.

I'll try and be quick. I wanted to ask on the Kabi margin, which was obviously really strong in H1 and now you're pointing to the upside of the guide. Just what are the potential moving parts that could drive that in 2H to above the guidance, maybe any areas you've been conservative? And then secondly, shifting to Helios Germany. I really appreciate that bridge that you guys laid out into 2021 margins. I wanted to ask on that volume and price up. It looks like million to $30 million.

Is that helped by growth and efficiencies from the clustering initiative. Is that something that you could have ongoing every year? Just any more color on how to think about the sustainability of that would be super helpful. for squeezing in.

Look, I think on the Helios, I think we said to that bridge, what we wanted to say. And it would not -- we didn't put a ruler on to give you a EUR 30 million up or down in 2027, right? I think what was true is that, that system of incremental price increase will continue to persist and will be there. And what's also holding true is that volume remains for us a key focus. And that through initiatives, we want to attract and retain more patients into our clinics. We have the right network. We have the right referral system, and we will continue working on that to make sure we get the volume.

Don't forget, as the largest network as a network, you have totally different effects, you can levers to play with an individual hospitals. Procurement power network effect, if you automate something, if you standardize something, you can scale it immediately through your network. On the guidance, I would -- look, this is not about us being conservative. And then one thing I said we will not gear it that we get to the upper end at the end of the year. This is running a business. We have great momentum in the businesses.

So if the businesses continue to deliver great momentum, great top line grade earnings conversion, then we will see how much we get to the upper end of that thing. By the same token, if we read the newspaper, there are a few topics which are also not getting easier with regards to input costs, the secondary effects of the Middle East were oil prices, so derivatives of that one feedstock granulates and so on forth. That is, by the way, all baked in. This is not additionally -- and this is -- these are things which maybe are for many other companies, headwinds to rather adjust the guidance to somewhere else. We have baked that one in, and that's it.

Super. So last question from Falko [indiscernible] Deutsche bank, please.

I'll keep it to one. If on the rituximab approval news, could you add some color on how financially meaningful this could potentially become for your biosimilar business? And whether you see this as a potentially larger opportunity.

Yes. Well, a, I think we need to put to into perspective. First of all, I think it's not a secret to the market that we are a little later ER than expected because this is not an inbound molecule. This is with a partner, and they also had to work on getting the regulatory approval. That means there are some folks already out there on rituximab. So it will be a more crowded space. But nevertheless, if you have a platform and have another additional molecule. This is an advantage vis-a-vis the customer.

But I see this more in '27, late and beyond we'll get -- first of all, we have the approval, and we need to get the [indiscernible] in order to charge and everything. So there's a few steps still to be taken before you then commercialize. And on the commercialization, I would always do some sort of an incremental costing. But the -- what we see in the U.S. with our biopharma team has tremendously achieved under the leadership there is that we changed our go-to-market on a key account management basis and on a, let's say, pricing and terms and condition basis.

And with a key account, you always talk about what is the breadth of your portfolio a key account management is always different to individual transaction because it's based on deeper relationships and trust. So therefore, it is an important thing, but it is coming a little later than expected, but it's now there. Still a few steps to go and it will add value.

And given that there are no further questions, we can conclude today's call. So thanks everyone for their participation. And obviously, with Mike and Sara, we'll look forward to meeting you in the coming days and weeks. And with that, we shall get you all a very good day.

We want to thank Fresenius and all the participants for taking part on this conference call. Goodbye.

Good afternoon, and welcome to the conference call of Fresenius Investor Relations, which is now starting. May I hand you over to Nick Stone, Head of Investor Relations. .

Thank you, Valentina, and hello, everyone. Welcome to our Q1 2026 earnings call and webcast. The presentation was e-mailed to our distribution list earlier today and is available on fresenius.com. On Slide 2 of the presentation, you'll find the usual safe harbor statement. Unless stated otherwise, we'll comment on our performance using constant exchange rates. Today, I'm pleased to welcome Michael and Sara, who will present the results of another quarter of competitive growth. As usual, the call will last approximately 1 hour with the presentation taking around 30 minutes with the remaining time for your questions. We can always come back for second round if needed. And with that, I will now hand the call over to Michael.

Thank you, Nick, and welcome to everybody joining us today. I am -- we are pleased to report an excellent start to 2026, fully in line with our expectations, building our great momentum and reconfirming our full year guidance. As always, Sara and I will walk you through the key operational and financial highlights of our individual businesses within Kabi and Helios in a moment.

Rejuvenating action means that our next strategy phase of future Fresenius is in full suite with greater focus, speed and sharper execution 2026 is all about accelerating our performance and building a resilient health care company for the future by upgrading our core with targeted investments scaling our platforms and further elevating our performance.

It's about being consistent quarter after quarter and team Fresenius is fully aligned. We keep doing what we're doing but do it even better. The first quarter demonstrates that Fresenius is better prepared than ever delivering strong results in a market dominated by geopolitical tensions and global uncertainty, which continue to shape the operating environment.

Recent developments in the Middle East are a clear reminder that volatility is no longer temporary. It has become a constant taking center stage in the boardroom. Over the past few years, we have fundamentally reshaped our company, simplified our structure, strengthened our balance sheet and build more agile and competitive operating businesses.

Consequently, we have a different organizational and leadership maturity level, which provides resilience and flexibility to navigate uncertainty while staying firmly on core to deliver on our future Fresenius ambition. This is impressively reflected in our Q1 performance, which once again proved we delivered on our commitments. Core EPS grew by 13% in constant currency, clearly outpacing top line growth, driven by operating strength and nice operating leverage and we've been achieving this while investing in innovation, if you look at the OpEx development.

Our Kabi business remains a strong performer with growth vectors moving closer to our recently upgraded structural margin band of 17% to 19%. Helios delivered a strong EBIT margin of 10.5% with double-digit EBIT growth in Germany and Spain, a great achievement. Our balance sheet continues to strengthen with net debt-to-EBITDA improving to 2.6x.

We're now moving towards the lower end of the self-imposed leverage corridor, which in turn enhances our strategic and financial flexibility in a challenging macro environment. Future present is delivering and encouragingly, this was most recently recognized by S&P Global Ratings, which revised Fresenius' credit outlook from stable to positive.

This reflects a lot of hard work over the past several years and demonstrates our commitment to delivering long-term profitable growth and balance sheet strength while positioning the company for future innovation-led growth. The S&P rating marked the best credit position in our history, which is a testament to the strong progress Fresenius has made.

Acknowledging today's challenging operating environment, I remain confident in Fresenius' resilience and adaptability. Today, we are reconfirming our full year 2026 guidance with great confidence based on this quarter's performance with 5% organic top line growth and strong 13% EPS growth at constant currency.

Now let's dive deeper into our core businesses with Kabi and Helios, both of which delivered very strong performances during the quarter. At Kabi, we are accelerating new product launches and innovation to further strengthen our market leadership position. In pharma, we continue to expand our IV therapy portfolio in the U.S. converting our pipeline into commercial launches most recently with a new premix ready-to-use, ready-to-administer solution in our freeflex bag. Generic drugs and biosimilars currently remain largely sent from U.S. tariffs. We continue to double down on our pipeline and launch excellence, while further strengthening local for local value chain by diversifying suppliers and sources, mitigating risk and building supply networks to ensure long-term success.

In Nutrition, we are maintaining a strong pace, expanding geographically and accelerating our innovation pipeline. In Q1, we completed 2 new global launches in enteral nutrition to support patients with additional nutritional leads, including those at high risk of malnutrition. And we also launched a new product to address the specific dietary needs of dialysis patients.

In parenteral nutrition, we continue to gain market share in the U.S. And within just a few years, Fresenius Kabi has established itself as the leading provider of liberty emulsions. Overall, our Nutrition business continues to deliver attractive growth with highly accretive margins. In MedTech, we secured a multiyear contract with a major French GPO in infusion, an important commercial win. And we achieved another milestone in Q1 with Class III CE certification for our blood bag systems under the medical device regulation in Europe.

Now let's turn to Biopharma. We continue to see excellent momentum across all regions with our launch portfolio, broad portfolio starting this year very strongly. Tyenne, our tocilizumab biosimilar continues to gain sequential market share with 40% and 27% in the top 5 EU countries and the U.S., respectively. Given our early launch, we secured many exclusive contracts in both Europe and the U.S., giving us a meaningful head start and supporting continued share momentum.

Otulfi our Ustekinumab biosimilar has now launched in 16 markets worldwide. In France, we see encouraging momentum, including the introduction of our substitution and contract wins, including the country's largest retail pharmacy, where Otulfi positioned as the #1 product. In addition, and that is part of the press, our U.S. team recently secured a contractual agreement for Otulfi with a large federal buyer.

With denosumab, we are currently positioned in the top 3 across selected EU markets and have reached 8% market share in EU 5. Most recently, we achieved regulatory approval in Canada, further underscoring the strong consistent progress we are making. Next, let's focus on the highlights in our care provision business. Fresenius Helios where performance was positively impacted by increases in inpatient admissions and pricing. We also continue to speed up innovation and digitization to improve operations in our core businesses.

In Germany, we are accelerating the adoption of technology and AI through our recently announced strategic partnership with SAP. Together, we invested in Avelios Medical, a state-of-the-art hospital software developer, which will enable us to build an open, interoperable and AI-enabled digital ecosystem. Through this investment, we are targeting innovative software that will improve clinical workflow, efficient support and ultimately productivity.

At Quironsalud, we continue to advance medical excellence and quality with 14 hospitals now recognized in the 2026 world's best hospital ranking, a phenomenal achievement. In addition, a peer review publication in the New England Journal of Medicine Catalyst demonstrated clearly that value-based cost for operators consistently outperform traditional public hospitals across quality, efficiency, patient satisfaction and cost per capita.

This demonstrates that you can scale profitability within Universal Health Systems while improving access for lower income population, reinforcing our confidence in the long-term resilience of our model. Let me spend a moment on the current German regulatory environment, which obviously remains key in investor conversations. And let me use this opportunity to separate the wheat from the chaff. The German health care system is under increasing pressure.

Structural inefficiency, rising deficits in public health insurance and many hospitals operating at a loss are driving the need for report. Policymakers acknowledge the challenge and are responding with measures focused on outcome quality, efficiency and spending discipline, including income-oriented expenditure controls. So if you take it through tomorrow's environment favors scale, quality and excellence, strength that differentiate Helios.

We are further executing our cluster strategy, concentrating complex medical services center of excellence while maintaining strong regional network. Helios continues to be Germany's most efficient hospital operator. We're utilizing digitization and AI to achieve additional productivity and efficiency improvement, all while enhancing care delivery and patient outcomes. The newly proposed regulations accelerate our strategy, enabling Helios to emerge as a long-term champion, delivering quality, scale and innovation.

It's an opportunity for us that reinforces our established competitive advantage. We can work with the current and future regulatory environment we are part of the solution, and we're going to thrive through it. And our ambition vis-a-vis our business remains and prevails. As I mentioned, we are operating in a more volatile geopolitical environment with the situation in the Middle East, the most recent example. However, given our resilient operating model, the direct impact on Fresenius remains limited and manageable.

Our balanced portfolio and active measures to create a more agile operating model have proven highly effective, even allowing us to increase R&D investment this quarter while also improving gross margin despite continued uncertainty. On Supply and Logistics, we have largely maintained operations through proactive rerouting and disciplined inventory management. We're also doubling down on local for local manufacturing to further strengthen resilience and flexibility.

Obviously, we're closely monitoring the situation, including potential secondary effects such as higher material input costs, and we're also taking the necessary actions to secure supply chain providing continuity while mitigating risk. On energy, we are well protected with an active hedging strategy for 2026 and 2027 that we continue to review given the dynamic situation.

Overall, this again underscores the strength of our operating model, diversified exposure resilient supply chain and disciplined risk management. We remain focused on execution while remaining agile in this operating environment. Across Fresenius, our businesses, all our businesses are structurally resilient, not just cyclically defensive, but strategically positioned to perform through digital disruption and geopolitical volatility.

Our products are system critical and essential, highly regulated and deeply embedded in health care assistance and patient care. Combined with our vertically integrated manufacturing footprint and local for local supply chain, this creates a strong moat and reliable cash generation. As Europe's leading private hospital operator, we provide critical health care infrastructure digitalization and AI further strengthen our ability to drive efficiency while simultaneously improving patient outcomes.

At its core, this remains a highly differentiated nonreplicable business defined by human touch. Together, Fresenius benefits from 3 layers of protection, a mission-critical role in health care, high real asset entry barriers and defensive growth characteristics. This resilience reinforces not limit growth. Our growth vectors are contributing increasingly to earnings, while our stable cash flows continue to fund investment and transformation. That combination resilience and growth is central to rejuvenate as we upgrade our core and scale our platforms.

With this, over to Sara.

Thank you, Michael. A warm welcome to everyone joining today's call. Q1 marks an excellent start to the year for Fresenius. The print demonstrates the continued operating strength of our core businesses and the resilience of our financial performance, fully in line with our expectations for 2026.

We delivered solid organic revenue growth of 5% and within our guidance range and in line with the expected full year phasing we outlined. EBIT grew by 6% at constant currency with a margin of 11.8%. And both Fresenius Kabi and Fresenius Helios drove this strong performance. I will come back to the operating companies in more detail in a moment. Core EPS increased by an excellent 13% at constant currency. The factors drove this. First, operating strength and nice operating leverage in our core businesses. Second, a year-on-year reduction in interest expense; and third, a lower Q1 tax rate.

A technical remark on core EPS. In addition to Fresenius Medical Care, we also adjusted for [indiscernible] which was part of the former Vamed and is reflected in the equity result. In Q1, we had a substantial positive contribution from a divestment on their end. Operating cash flow was very strong, especially compared to historical patterns.

On the back of a nice cash conversion, leverage improved further to 2.6x net debt to EBITDA, which is firmly at the lower end of our self-imposed target corridor. Turning to Fresenius Kabi, we saw continued strong operating momentum and disciplined execution with a good start to the year across all KPIs. Organic revenue growth reached 6%, fully in line with our full year indication and the expected phasing for 2026.

We expect to ramp up over the course of the year as we continue to execute several launches and rollouts. Both factors delivered 8% organic growth. Biopharma was the driving force here supported by strong volumes and further in ramp-up. Nutrition developed in line with our structural growth ambition despite the [indiscernible] in China. Importantly, all other regions and product groups performed well in the quarter. MedTech grew against the strong prior year base. Organic growth in pharma at 3% was driven by positive development in Europe, strong volume growth and lower pricing pressure in the U.S.

Kabi's EBIT margin reached a strong 16.7% despite delivered and targeted R&D investments, particularly at Med science, as well as the [indiscernible] headwind and some negative impact from U.S. tariffs. Beyond top line growth, the strong margin reflects improved operating leverage and continued cost efficiency. EBIT was up 4% at constant currency in the quarter.

Both factors delivered a 40 basis point margin expansion year-on-year to 15.7%, primarily driven by significant improvements in Med Tech. On pharma, please keep in mind the elevated prior year margin also helped by the positive onetime effect, which creates a tough comparison. Helios delivered a solid top line performance against strong comps in both Germany and Spain, yield margins picked up year-over-year to 10.5% in which is at the upper end of the full year indication.

In Germany, organic growth was at 3%, mainly price-driven. The good inpatient admission growth we saw in the first quarter was partially offset by case mix as expected. As a reminder, the 3.25% surcharge for publicly insured patients is recorded as other income below the revenue line. If we included it in revenue, our organic growth for the first quarter would be close to the upper end of the structural growth plan.

EBIT grew an excellent 10% at constant currency. The EBIT margin of 8.3% implied a 60 basis point expansion year-on-year. In Spain, organic growth of 4% reflects stable underlying business dynamics with solid activity levels, positive pricing and continued growth in the ORP business. Political backdrop in Colombia, some would adversely impacted the top line. EBIT growth of 10% at constant currency against the strong higher comparison was driven by solid top line translating into operating leverage with additional support from a smaller divestment.

At around EUR 390 million, we achieved excellent operating cash flow in the first quarter, especially compared with historical patterns. This was driven by phasing effects at Helios as well as a strong underlying performance and successful working capital management at Kabi. The strong Q1 helped us achieve an excellent EUR 2.9 billion in operating cash flow over the last 12 months. This clearly demonstrates our continuous improvement as we execute our disciplined and focused cash management approach.

Free cash flow for the last 12 months totaled EUR 1.4 billion, including EUR 218 million in proceeds from our pro rata sales alongside the Fresenius Medical Care share buyback. This is now completed. In Q2, our proposed dividend payment of EUR 1.05 per share will be reflected in free cash flow. Our successful cash conversion continued in the first quarter with the last 12 months cash conversion rate of 1.2.

Fresenius is now much stronger and more resilient company also financially. For me, this starts with a substantially strengthened balance sheet, since 2022, we have reduced net debt by EUR 3.5 billion or more than 25%. That's why we can now benefit from a significantly improved interest line. Over the same year, leverage decreased by 120 basis points, firmly placing us at the lower end of our target corridor of 2.5 to 3x net debt to EBITDA.

Remember, this is before the dividend payment next month. We remain very comfortable with our trajectory for the remainder of the year and continue to target this range by year-end. The rating agencies have recently acknowledged our progress and strong commitment to an investment-grade credit rating. S&P upgraded its outlook for Fresenius resulting in the company's best credit position ever.

Our improved leverage provides significant strategic flexibility meaning we can and will invest in long-term profitable growth by upgrading our core and scaling our platforms as part of our rejuvenate agenda even and despite a challenging operating environment. That's the balance sheet, but our financial resilience equally materializes in our P&L and cash flow performance.

Also here, we have paved the way for targeted investments and the size of opportunities from a position of strength. Over the past years, Fresenius has become a leaner and more agile organization. In a challenging dynamic environment, we respond quickly and effectively to changes by focusing not only on risks, but also on opportunities. A key element of this resilience is driving structural productivity.

In 2025, Helios over delivered on their performance program compensating for the meaningful energy relief headwind. At the same time, Fresenius Kabi is a fantastic job in driving structural productivity improvements across the business on their side. Importantly, these measures are not one-offs. They are sustainable in nature. Improving operating leverage today will benefit tomorrow's performance, and both operating companies are well positioned to deliver business excellence throughout 2026 and in the years ahead.

Finally, we remain highly focused on generating strong and reliable operating cash flow. Cash conversion is a central element of our financial framework. After 2 years with a cash conversion rate above 1, we expect it to be slightly below 1 for the full year, also reflecting our growth tractor. Our disciplined cash management provides the basis for allocating capital to our strategic priorities of investing in future growth while ensuring attractive shareholder returns and maintaining a strong balance sheet.

So in conclusion, our Q1 performance is fully in line with our expectations and the strong start to the year underpins our confidence to reconfirm our full year guidance. To date, we have not seen a material financial impact from the Middle East conflict. Our direct exposure to the region is limited and energy supply largely hedged for 2026 and beyond. That said, the situation is fluid. The duration of the conflict will influence potential second order effects from the supply and pricing of input materials.

As laid out in today's presentation, Fresenius has the operating and financial resilience. We have trained the muscle to drive structural productivity while seeking opportunities. and demonstrated last year when we had to compensate for significant macro headwinds, proof of what we can achieve. FX continued to affect reported numbers and if exchange rates remain as at 31st of March, we would expect an annual adverse impact of approximately 1% on revenue, EBIT and net income, respectively.

Turning to expected savings for the full year. We continue to expect ramp-up at Kabi. The Cape effect started during Q2 last year, but please remember that the full effect will only annualize in Q3. Helios Germany surcharge remains in place until the end of October. As always, our guidance does not reflect any potential extreme scenarios from a fast-moving macro and geopolitical environment. As the year continues, we look forward to keeping you updated on our progress.

And with that, I hand it back to Michael.

Yes. Thank you, Sara. Look, Rejuvenate is well underway. And given the strength and the maturity of our organization today, we are well positioned to navigate the current environment. We have repeatedly demonstrated our ability to execute and the resilience of our operating model. For example, in fiscal '25, we twice upgraded our guidance despite significant headwinds. At the same time, we further strengthened the quality of our portfolio and materially improve our financial profile. Combined with increased performance momentum and renewed agility, this gives us the flexibility to seize opportunities as they arrive. We're now operating out of a position of strength. Our excellent results this quarter provides another clear proof point.

More than 3 years ago, our priority was clear, stabilized Fresenius, simplify the structure and rebuild credibility. That phase is now largely complete. Today, under Rejuvenate, our focus has shifted -- we're accelerating performance and building a business that grows consistently, profitably and with discipline. We're not looking to be labeled as a compounder today. What matters to us is execution over the coming quarters and delivery against our commitments. I am very confident in this both in terms of delivery and on our near- and long-term prospects.

Rejuvenate is about innovation-led growth. We are expanding through platforms with substantial growth potential as we continue to scale. Our advantages include unique capabilities such as injectable small molecules and biologics extensive regulatory access and deeply embedded hospital relationships. We are deliberately allocating capital to deliver long-term profitable growth, doubling down on our attractive biosimilars pipeline ahead of what other label gold and age of loss exclusivity and leveraging our expertise in preparation for future relevant modalities.

Fostering our leadership in clinical nutrition by providing even more targeted, more specialized products to patients globally. -- adding specialty pharmaceutical products that deliver clear value to patients, providers and health care systems. All of these drive durable volume-led growth in structurally resilient nondiscretionary spend market. We're not betting on a single product. We are building strategic infrastructure and system critical health care services.

At the same time, we also manage our structures. We prioritize clarity of complexity with every business playing a defined role in the portfolio without ideology. We run Helios for margin discipline and free cash flow with a clear commitment to best medical quality and patient satisfaction. It is not our growth engine, but it will continue to grow steadily in volume and price contributing to steady earnings growth. We remain ready to act on structures and opportunities when value can be created.

The deconsolidation of FMC is a clear example that this discipline is real and not theoretical. Capital allocation is central to how we operate. every euro we invest must meet clear return thresholds. If it does not, it is literally returned. This discipline is reflected both in where we invest and where we deliberately choose not to invest. With our 3 platforms, we are well positioned to deepen our impact and advance our mission to save and improve human life through affordable, accessible and innovative health care products and the highest quality of clinical care.

With that, let's move to Q&A.

[Operator Instructions] The first question comes from Graham Doyle from UBS.

Obviously, really solid quarter given the backdrop. Just a couple. So firstly, just on the guidance and sort of the trajectory as we go through the year. It is early days, but you've obviously done a 13% and the guide is 5% to 10%. Is there any reason you'd expect growth to materially decelerate as you go through the year? Or is it just a case being cautious?

And then the second question is just around the balance sheet, which is clearly materially deleveraged versus when you took over in late 2022, given where the share price is, what sort of flexibility is there to perhaps do something around buybacks?

Yes, Graham thanks for that one. If we start with the latter one, and I got to say, Sara is the guardian, the custodian also of the balance sheet and then capital allocation. And I heard the CFO also encouraging innovation-led growth. So if we think about the use of capital, I would -- in the packing order, probably your option would be way back. But that's what it is because we have much better alternatives.

On the guidance, you said it. It's early days, but I would also like to draw everybody's attention to our tone. This was a great first quarter outside world remains volatile. I mean a couple of days after our last earnings call, the war broke out in the Middle East nobody saw that coming. And suddenly, we are all confronted with that one. When we look at what we can control and what we see and where we have visibility, already Q2 is very encouraging already on the growth progress.

You may have heard that I said hot of the press, this new contract on Otulfi with the federal. So there are many data points, which make us confident for Q2. And yes, as we said from the outset, that's why we emphasize the numbers are fully according to our own expectations with the ramp-up we wanted to have operationally, obviously, and there is work to do. But I think we are on a very good path. The first month is under the belt. Also that one looks good. And as we move on, we would rather compound execution.

And once it gets more tangible, then we turn it around. It's much better. It's more comfortable.

The next question comes from Hugo Solvet from BNP Paribas.

I have 2, please. First, Michael, you alluded to that VA contracts. When going on the via website, I can find a $140 million contract annually for renewal every year for 4 years. Could you confirm this is the contract that you're referring that your teams have secured? And second on Elior Spain, there's been a bit of noise recently. Can you maybe expand a bit on the contribution of private public partnership in Spain. Where do you come from a sales and profitability perspective? And when or if some of them will be expiring in a distant future.

Yes. Let's start with the latter one. Don't expect anything in the near term, midterm or whatever, the next couple of quarters, maybe not maybe even years, we will not probably maybe even decades will not be talking about that one. I referred to noise in Spain. There is a lot of noise. It's not like Germany, but you have a social government, but you also need to consider as always, the federal level, and then the at the state level and then you even have the city level. So we feel very comfortable. There's some noise on public-private partnerships. We'll see whether it passes at all and what changes in there.

And by the way, it's only a fraction of hospitals. I mean, we got, what, 63 hospitals over there. So it is looking at the number of hospitals, I'm not really worried. The other one was on the contracts for you said VA, I didn't say VA, I said federal. And yes, it's a nice contract, the neighborhood you said is fine. It's EUR 440 million. What for me is stunning or very -- let's say, very positive on that one. It's, first of all, a big contribution to the value driver in the pharma, biopharma business in the U.S., which is a very important market on a very competitive molecule because it is Otulfi.

And that is also a function, again, Rejuvenate. We have a great leadership team over there. a new leadership team. It's actually a female leadership team on the go to market. And we can see that she and her team are really hitting it off. What makes me even more happy is that also on the pharma side, last year, we have been opening up this customer segment, which I would call federal customer segment was primarily in the past, we were very much focused on the B2B hospital via GPOs, which will be the dominant and the lion's share. But this is also rejuvenated opening up new channels, new customer segments and if I look, by the way, maybe we'll disclose that in one of the quarterly meetings, what is the uptake in the customer segment federal, it is actually nice. So it works on both ends.

The next question comes from Aisyah Noor from Morgan Stanley.

My first one is on the Nutrition business, which I believe Exito has been doing already closer to the high single-digit growth for a few quarters now. With the product launches that you plan this year. Is there a chance this actually hit double-digit growth in the second half or fourth quarter?

And is this kind of assumption perhaps embedded within the copy growth guidance range here? And then my second question is on Helios Spain, maybe a financial one for Sara. I believe you recorded a onetime sale of a hospital asset here. Could you quantify the financial impact of this transaction on sales and EBIT for the quarter? And do you anticipate any more exits in the coming quarters?

Sure. Happy to start with that one. It was actually a minority holding we have in more of an investment company. So it was not core to us. And the majority owner decided to sell, and we sold a long it was small. If I take it out of my EBIT, I'd probably be in the range of between Q1 last year and Q1 this year in terms of margin. So nothing to be excited if so wanted to disclose for transparency.

Yes. And on the nutrition one, I think that may be a little bit too far fetched, but I would want to reinforce, let's say, the narrative I heard in your question. This is a very strong business a very resilient, very high entry barriers. And you rightfully pointed out, I mean we saw the 4.1% growth in Q1, against the backdrop of Q2, which was meaningful because we had the full quarter. Even in quarter 2, as Sara alluded to, there will still be some keto effects yet they want to compensate for that one.

And I would expect also their growth rate, particularly in Q3, Q4 to go up. And this is also a function, first of all, technically out of the keto effect, but also the new product launches. I mentioned in my speech, 2 are there. So we're going to ramp them up. You have the integral, if you so wish of those 2 and then Q3, Q4, three more are coming. We said are targeting 5 new launches in Nutrition. So another three are coming to further bolster growth. More towards Q3, Q4 and then obviously, given, again, momentum going into '27.

And I would also expect that Q4 will be stronger than Q3 in terms of growth rate.

The next question comes from Hassan Al-Wakeel from Barclays.

So firstly, on Helios Germany. Sara, when we met earlier in the year, you talked about the potential for other measures to help offset the surcharge loss in '27 over and above the 1.14 base rate adjustment should inflationary pressures persist. As things stand today, this looks to be offset by the 1% discount from the draft bill. So I wonder if you still stand by your comment and whether you view consensus expectations of a small margin decline in Helios Germany, 27% as reasonable, again, based on what you see today?

And then secondly, maybe another 1 for you on cost inflation. I appreciate you are hedged on energy for this year. Can you talk to the extent to which you're hedged for next year and also the impacts you're seeing on other cost bucket inflation and any mitigating measures you're taking for this year, but increasingly into '27?

Sure. And happy to start with your last question. So as I said, for 2026, we are significantly hedged on the energy side. For 2027, we will also have hedges in place in quite a substantial manner, actually. And that goes across electricity and gas I think what is a little bit harder to judge from a current perspective because also the situation still remains a bit fluid is those, I would say, second order effects in terms of supply chain.

And that goes to inflation on plastics like [indiscernible], but also on logistics. If I talk about logistics, of course, we have longer-term contracts and sales, some of which give a natural hedge to any shorter-term price inflation, some where we are a little bit more kind of vulnerable. However, for us, the growth rate, we feel comfortable there. The longer the conflict actually drags and the higher the overall inflationary environment. Obviously, we are not immune against both secondary or effects. However, I think what we've done consequently, since a couple of quarters now look into that supply chain resilience and stability and double down on secondary suppliers, making sure our supply chains are in order and intact. So overall, let's see how that situation pans out, but I think we tackle it from a position of resilience and strength.

When I talk about Helios Germany, I think you said for 2027 was likely there will be a wash between what's currently ongoing on regulation in terms of the additional EUR 1.14 billion versus the reduction of 1 -- what I meant back then, and I think that still holds true, and I think the whole hospital reform maybe last week end of the stabilization export hospital reform exactly tackle that. We need structural reforms.

We need digitalization. And actually, we also would love to see a certain angle of deregulation. Because in the end, I think what those reforms will do, they will reward the most efficient and highest-quality hospital platform. And so I do believe we have measures we can draw on be it to the clusterization effect, be it through the focus of care we provide through the clusterization making use of actually the infrastructure we have and if you so wish, making that more productive, looking both digitalization efforts across the hospital.

And again, I think, in particular, if you look at digitalization, it's a huge difference on whether you run 1 hospital or you run a hospital system because as you roll out digitalization, there is a lot you can do for quality, but also for efficiency. And so I do believe we have a lot of levers to pull. You know 2020 size was a year where they set up a company program and delivered more than EUR 100 million of savings that was on procurement and going back that was also on medical processes and digitization, and that's a rule we will, of course, continue going and driving forward.

Hassan, if I may, add to more strategic aspects of both questions. Obviously, it's absolutely right what Sara said. But I have been talking a lot about resilience and better quality. These are not just words for the script just to give you a little bit of a flavor, this -- first of all, remind everybody this is not an energy-intense business, on the hospital side, this is the whole question on which you guys have and others have on the reform.

It is very much, of course, not most driven. It's a service business. So it's not an energy-intense business. Also Kabi in its manufacturing as such is not an energy-intense business. There may be input materials are alluded to, for example, where oil is the feedstock, granulates and the like and obviously, freight costs. Now bigger picture, we also have local for local. So the more we build on local for local, the more we build on local manufacturing, supply qualification, supplier base, logistics, warehouses, hubs, obviously, we do not have to go over the ocean.

That is one hedge. The second thing is we -- from what we see today, we can all work with even on our scenarios on secondary effects because the business is growing. And the business is growing with nice gross margins, particularly in growth vectors. And with growth factors, for example, biopharma is even less exposed to those whole energy-related things, so I want to remind everybody on the whole Kabi business, for example, that I see -- we have earnings visibility, and we feel confident with the resilience concurrently being growth.

They are reinforcing each other. And then again, what I said, it is Central and system. And on the German hospital thing, also don't forget, Sara alluded to that, we have that network effect. The fact of the matter is that most of the hospitals are in red ink and the budget the physical federal budget is growing, and that is what they try to tackle with new law. And in essence, what is and remains intact is the volume is growing in that business.

Procedure growth is intact. Volume growth is there. We just have to pick it up whilst others may be struggling with the new regulation since they are underfunded anyways, they may even ultimately go out of business. So our investments into digitization, networks effect, clustering strategy is all there to then be ready to pick up those patients. And once we optimize the network, the cluster strategy, we can guide patients as to where they need to be in order to get capacity utilization.

The second thing, also the reimbursement, the pricing is intact, show me one business on the planet where other than maybe grids and utilities, where you automatically buy a regulatory framework, get a price per procedure. We don't have to fight with no product, no innovation. Now yes, there are a few regulatory changes and puts and takes and so on and so forth. I would say, by and large, in the long run, on average, the increase in price in percent matches the increase in costs. By the way, the base is higher on the price, which is already good. And then we have levers.

First of all, as I said, volume -- and the second, all efficiency measures, and we can run you through very much detail on all the efficiency measures we can take. So I want to just take off the table that there is any clip in '27 on beyond. Other than that, we would have upgraded our financial framework to the downside.

The next question comes from David Adlington from JPMorgan.

They're actually almost all been answered. But -- maybe just on energy cost, maybe just push you a little bit further, Sara. Obviously, you said it's pretty much fully hedged for '26, but maybe you could just quantify the exposure for '27 either your total energy spend or how much of that is hedged would be useful apart from that all out today.

Yes. I mean, I think as Michael said, on the energy bill overall, I think we're not energy intense per se. So it is something we look at. It is something-- and also maybe on hedging to give you a little bit of more perspective there. We talk about advanced purchases, right. And so we're rolling them and we are rolling them in half upto 36 months and make use of the market opportunity we're seeing. And if I look at 2027, it's also way above the 50% hedging ratio. So depends a little bit if you do double click on electricity and gas, and that depends a little bit between Helios and Kabi, overall, it's way above those 50% and closer to 2/3 actually.

Perfect. And then maybe just on the contract you secured the federal contracts you secured. How accretive is that to margins? And if you anticipating that when you gave your margin guidance?

David, can you just repeat that? Sorry, the line drop down.

Yes. On the federal contract that you've won, I just wondered how accretive that was some margins and was that considered, so.

We don't disclose individual contracts, but I can go into the very integrity nitty-gritty details of the fundamentals of cost accounting because if it's an incremental contract, it will be accretive if you build on fixed costs. So -- but look, individual contracts, we do not disclose. We appreciate you trying.

The next question comes from Oliver Reinberg from Kepler.

First question would be on Helios, the Q1 margin, which expanded in Germany by 60 basis points. I think I would exclude the surcharge, it was probably down by 140 basis points. Now I understand that the pricing ex surcharge may not fully cover kind of inflation, but you're also obviously ramping up your kind of efficiency program. So I just wanted to get your thoughts on the kind of Q1 Helios margin? And then secondly, I think in the U.S. IV generics, you talked about a more friendly competitive landscape.

So can you provide some kind of more color, and finally, just on the German health care reform, you talked about the kind of volume opportunity that is going to arise from the consolidation. I wonder is there also any kind of new opportunities now to strike contracts with healthcare insurance on.

Maybe let me take the surcharge question. I mean, for me, the question is not with the surcharge fee there or not be there. The question is the top line or is it other income? And if it were to be a top line, how if you look at it compared to last year, the DRG last year, it was around 6%. If you combine surcharge plus DRG, it's as well around 6%-- so if I look at that, the surcharge being top line, then obviously, my margin drop is not that material, if I were to exclude that.

Oliver, can you repeat your question on IV U.S. What was it?

Sure. My understanding from your prepared remarks was that you talked about a more friendly pricing environment in U.S. generics, but I haven't misunderstood that. So just wondered if you can provide more color on that.

So U.S. generics, I think -- are you referring to -- so Q4, we have seen quite a bit of price pressure on U.S. generics. And in Q1, we're actually seeing that there is lower price pressure on the U.S. generic side, I think conceptually, however, we continue to expect for 2026 continued price pressure in the low to mid-single digits. So I don't think that the environment will change quickly. However, having said that in Q1, indeed, we did see a lower price pressure.

Yes. Maybe when you meet competitive landscape, let me highlight another point. According to IQVIA data, last month was the tenth month in a row, where we have been the #1 with roughly 19.5% market share in the U.S. with our broad portfolio. So when we talk about competitiveness, it is that broad portfolio geopolitically or from a national policy point of view, we are manufacturing in the U.S. and thereby solving the problem of drug shortage. And we also launched -- we talked about launch excellence.

We also launched 2 products or launch more products in 2 areas in anaesthetics notes in analgesia and that is in these 2 areas. And by the way, if I also look at the competitive landscape during the earnings season, I think we did pretty good overall in the U.S., if you look at the growth rate in the largest and most profitable market, it is amazing how we grew 8% year-over-year with the entire portfolio, not IV generic.

The next question comes from Oliver Metzger from ODDO BHF.

Yes. One on Helios Germany. So you reported a negative case mix effect, which comes made from the hybrid DRGs, -- is this a trend which you expect to continue out for the next quarters? Or is it a specific Q1 effect? Second question about in pharma. You reported a better momentum in Europe, its pretty [indiscernible] comment on Europe specifically, but can you remind us how big roughly Europe for you in summer? And what are your expectations for.

We see more indication in creator hybrid DRG. However, and I think that goes exactly to the point Michael mentioned, using our infrastructure and making sure that we capture a good share of hybrid and that we capture that strong activity, both which was at 5% in Q1. I think this is what will generate the additional revenue top line in terms of volume.

Yes. On Europe, Europe in general did good. We had at a 9% growth rate and pharma also was good. I mean it was we always said that the average rate of pharma is 2% to 3%. Europe was at 4.5%. Obviously, we are the leader also not only a pharma and solutions. We are the leader, the clear market leader on solutions. And we are even increasing in our footprint and investing in that one. By the way, we also saw some pricing power -- it's not only price decreases across our portfolio, depending on the individual product we use. So I guess also in Europe, our strategy local-for-local is paying dividends.

Okay. Great. Just to clarify. So it means pharma the Solutions business was more supportive in Europe versus injected the generics. That's correct, ones, isn't it?

Pharma is injectable generics. We don't differentiate between those 2. This is 1 segment because the customer also buys both -- so that Pharma & Solutions grew by 4.5%.

The next question comes from Falko Friedrichs from Deutsche Bank.

I have 1 question on the health care reform as well. Given that it aims to generate further savings beyond 2027, just to clarify, is your statement that you don't see a cliff or a meaningful headwind to your Helios margin in 2027 and would be able to launch efficiency measures? Is that also valid for 2028 and beyond?

Yes. I mean I think what we outlined is how we're going to drive is structural. And so what we do this year will be there next year and will be there the year there. So I think it's the leverage we have from the infrastructure we have, which we will continue to invest in, in particular on the digitalization front and which will provide the uptick in 2017 and beyond, and that includes explicit '28 and '29. And also, let me remind you because there is also the prospect reform, and there was that amendment passed in March of this year.

And that also includes the EUR 50 billion on the transformation fund. I think that's an important angle. That's EUR 50 million for 10 years, so that makes EUR 5 billion. Yes, big number. And it starts this year. And obviously, as you can imagine, I mean, it's for project-related CapEx to actually manage that overarching transformation, which the government set out. Now obviously, our ambition is to launch a number of projects, and we have already applied number of projects, which will help to facilitate investing where we think the future of digitalization and procedural growth will go.

And obviously, we aim to capture more than our market share.

And Falko, maybe I think you and some of the colleagues may play even a very special role because Germany is also your home country in explaining what's happening here. Let me dissect it again. The fact of the matter is there is a need for structural reform, too many hospitals, too many in reading, too many too many things. There is already a law in place this KHAG [indiscernible] which is, let's say, the smaller version of the later of [indiscernible] This thing is already in place, and this is targeting a structural reform with quality metrics, life to scope and not everybody is allowed to do everything and so on and so forth.

All of that works completely in our favor. We're actually even doubling down in optimizing the structure. So don't forget that on that law is already there, and that is the primary target. And then you have the fund, which Sara mentioned, didn't see that in any report, which will help us 1 way or the other because it's money. And then third is now that stabilizing for the payers where, in essence, if we make it short, I'd say we can work with that. We will strive through that 1 without being very well positioned and we don't -- I mean, the 2 yeses you just heard is something money can't buy because this was not scripted. Nobody will fall off any cliff.

What we would be loving to have from the German government is more deregulation that, in essence, we could even double down on digitization and AI across our networks because their data security laws and federal laws between Hess and Berlin and all of these things are still in a way. And I don't give us hope. Hope is not a strategy, but we're also talking to them that they will also come to terms that, that is the actual kicker to get the cost out of the system, which will again also work in our favor.

So I think that was our last question. So [indiscernible] saying you a job, maybe Mike any final remarks you'd like to leave.

Yes. Thank you. Usually, I make it short, but this time, I want to reiterate because these were very intense weeks also in the run-up to the quarterly earnings call, I had some investor exposure, and I get the questions and, to some extent, nervousness on the German hospital reform, but that's why we were reiterating and highlighting the fact, the strength and that we're moving the ambition not change, not in the midterm, short term, not anyways. We're going with confidence.

Don't forget our portfolio, this is a volume-led -- we said at the beginning of the year when we talked about the guidance, everything is volume led on the Kabi side. Obviously, the factories need to be full. And on the other one, the factories for the hospitals need to be full -- we have clear growth matters in very attractive areas. I was calling another company, which was talking about the golden age of biosimilars with the LOEs, which you see.

We do not have, like other alternatives, maybe a 1 trick pony. This is a nice portfolio when logic is always 1 is very strong and resilient or free business is actually very highly cash generative and then fund the growth. We are growing. If you look at the quality of earnings, -- we did spend year-over-year, roughly 150 basis points on OpEx both. It was not only R&D, but also S marketing and selling. I was talking about new customer segment. So we deliberately invested 150 basis points, yet our gross margin also increased by 150 basis points, which tells you new products, new innovation are gaining traction. When it comes to the German hospital reform, Volume growth is almost a given.

The pricing environment is constructive. All those numbers, all those morning you hear is not about cutting anything. It is about maybe limiting the growth, and I talked about the equilibrium and how that works. Energy costs, Sara went through it in detail. I think this is very good. And then innovation-led growth. Biopharma nutrition, I like the question on Nutrition. We talked about the ramp-up Q2 biopharma already the good sign with the VA contract. Medtech having had a very strong quarter on profitability. Sara alluded to that one. By the way, a lot of rollout installations coming -- so with that one, clear capital allocation discipline, we have a very strong balance sheet, very, very strong balance sheet.

We know how to drive productivity, productivity now bolstered with growth, which is totally different than what we have 3.5 years ago. We needed to work for the growth, but we need to be relentless on productivity. Now we are as relentless to productivity, but we now we can cater concurrently growth. We have a nice balance sheet we have room for expansion, and we have an even monetary items.

With that one, I'll leave you with that.

Thanks very much. Take care, and we'll look forward to catching up on the voting for days and weeks.

We want to thank Fresenius and all the participants for taking part on this conference call. Goodbye.

Good afternoon, and welcome to the conference call of Fresenius Investor Relations, which is now starting.

May I hand you over to Nick Stone, Head of Investor Relations.

Thank you, Valentina. Hello, everyone. Good morning, good afternoon, wherever you are. Welcome to our full year and Q4 2025 earnings call and webcast. Presentation was e-mailed to our distribution list earlier today and is available on fresenius.com.

On Slide 2 of the presentation, you'll find the usual safe harbor statement. Unless stated otherwise, we'll comment on our performance using constant exchange rates, or CER.

Today, I'm pleased to welcome Michael and Sara, who will present another competitive performance, followed by an overview of the full year '26 guidance and the underlying components.

As usual, the call will last approximately 1 hour with a presentation taken between 35 to 40 minutes and remaining time for your questions. To give everyone a chance to participate, please limit your questions to 1 to 2 and we can always come back for a second round as needed.

And with that, I will now hand the call over to Michael to kick things off.

Yes, very well. Thank you, Nick. Welcome to everybody joining us today. Sara and I will review our 2025 operational and financial highlights. We will also go into more detail on our individual businesses within Kabi and Helios.

2025 was a great year for Fresenius. A year in which we delivered an excellent operating performance despite significant macroeconomic headwinds. 2026 will be all about accelerating performance and ultimately creating sustainable value. 2025 has been a pivotal year. We launched the next phase of our #FutureFresenius strategy, REJUVENATE, and it kicked off with really great momentum. We have sharpened our strategic paradigm, upgrade our core, scale our platforms, elevate performance.

Over the past three years, we have fundamentally reshaped Fresenius, becoming a stronger, simpler, and more resilient company. We've taken meaningful steps to enhance our position as a relevant player in the health care ecosystem of the future. This is now paying back in a highly volatile macroeconomic and geopolitical environment. Fresenius is in great shape, and we will continue to take the right steps to have the company in its best form to seize future opportunities.

In 2025, we delivered another year of strong and consistent execution. Our businesses contributed strong organic growth. Core EPS grew double-digit for the second consecutive year, clearly outpacing top-line growth, demonstrating nice operating leverage. Our balance sheet is now significantly stronger, with net debt-to-EBITDA at 2.7. We are now well within our self-imposed and improved rich corridor, more than 100 basis points better than 2022. This gives us enhanced strategic flexibility in a challenging macro environment.

All in all, 2025 reflects sustained progress quarter after quarter, year after year. We closed the year on a really strong note, achieving our upgraded guidance with 7% organic revenue growth and 6% EBIT growth at constant currency. Our Future Fresenius transformation continues to deliver meaningful value for all stakeholders. We've made the option faster, leaner, and more resilient. Return improvement and deleveraging remains central to value creation. Importantly, the transformation is energizing our teams across the company. Engagement is rising. Our shared sense of purpose is stronger than ever.

I'm pleased to announce that we are proposing a 5% increase of our dividend to EUR 1.05 per share for 2025. A clear token for our improving financial strength and commitment to delivering long-term value to our devoted shareholders.

Our focused assets are delivering tangible results and position us well for 2026. Across Kabi, we're advancing a strong wave of new product launches and innovations, leveraging our globally leading market positions. At Pharma, pipeline remains a priority, supported by the ramp-up of our Wilson, North Carolina site, further strengthening our IV fluid supply and US operational footprint. In a rapidly changing world order, we double down on our More in America campaign, exemplified by our new partnership with Phlow Corp. to establish a fully domestic end-to-end supply chain for essential medicines. We're fully focused on getting the business right. The trend towards a, let's call it, certain de-globalization means that we're also looking at our global value chains, it will set up our supply chains for the future.

Our nutrition business earns attractive, highly accretive margins, supported by innovation and targeted investments into attractive growth opportunities outside the VBP tender business in China. In MedTech, we're looking for sustained momentum from several contributions, one of them being Ivenix rollout, the most innovative pump in the market, which we expect to be a meaningful driver of incremental growth in 2026.

Biopharma remains a powerful growth vector, where we expect to remain on a double-digit growth trajectory, building on a strong finish in 2025. Our focus will be on commercial execution with continued rollout of our recently launched products, in particular tocilizumab, ustekinumab, and denosumab.

At Helios Germany, we benefit from our solid progress on our cluster strategy. Supported by volume growth and positive pricing effects, we're focusing on further efficiency improvements and optimization to sustain profitable growth. Helios Germany needs to step up in this regard.

In Spain, growth is driven by occupational health and positive volume and pricing effects, backed by our ongoing digitization efforts. We enter 2026 with real momentum, strong drivers across the portfolio, and a clear path to continued growth and value creation. However, macro volatility persists, highlighted by last week's U.S. Supreme Court ruling. Tariffs remain fluid, but Fresenius is well-positioned with 90% of group revenues unaffected by U.S. tariffs and 70% of our U.S. medicine produced domestically. We saw a structural organic revenue growth acceleration over the last 3 years, driven exactly by what we labeled growth vectors at Kabi and our rigorous strategy execution.

Looking at 2026, we anticipate continued dynamic organic growth, and we expect continued operating leverage, with EPS growing significantly faster than the top line. REJUVENATE is about innovating our portfolio, about keeping our portfolio young and relevant. The progress of our Kabi portfolio demonstrates this impressively. More than EUR 0.5 billion of fiscal 2025 revenue already comes from new products. If you look back some years, you clearly see how far we've come in reinvigorating an innovation mindset in Fresenius. I'm convinced that innovation is paying back, and the new products are impressively demonstrating that by being accretive to Kabi's structural margin back.

Let's turn to Biopharma, a core engine of our REJUVENATE agenda and a key catalyst of our performance acceleration. We continue to see excellent momentum in our of in-market molecules across all regions, despite some anticipated competitive pressure, closing the year on a very strong note. Tyenne, our first-to-market tocilizumab biosimilar, is charging ahead as the fastest-growing product in its class. [indiscernible] continues to accelerate month after month, proving the strength of our first-mover advantage and the durability of demand.

We continue to see nice market share growth, with 37% market share in EU4, plus the U.K., and 17% in the U.S., which is supported by multiple PBM and health plan contracts, many of them exclusive. Our ustekinumab biosimilar, Otulfi, delivered incremental uptake in Q4, supported by the launch of our 45-milligram single-dose vial, which provides dosing flexibility for pediatric patients.

Adoption continues to build, strengthened by our exclusive U.S. distribution agreement for our unbranded ustekinumab with CivicaScript, under which we completed first deliveries in December. In addition, we just recently received a positive EMA opinion for our auto-injector presentation. This is, all in all, excellent news. Our denosumab biosimilar is progressing as planned. In the U.S., we have signed more than 100 contracts since launch, with all major hospital and clinic GPOs contracts now executed. In Europe, we closed the year with solid commercial progress, including the launch of our denosumab portfolio, where we continue to differentiate with our unique prefilled oncology syringe, a key competitive advantage validated by exactly the contracting momentum I've been mentioning.

Looking ahead, we expect this momentum into 2026 and beyond, as existing contracts increasingly convert into prescription and the broader tailwinds behind biosimilar adoption continue to strengthen. The performance of our recent launches gives us confidence in exactly that story. As highlighted in our Biopharma Meet the Management event, our marketed portfolio and pipeline put us on a clear path to double revenue by 2030, while progressing toward an EBIT margin of around 20%. This will be driven by further launches, deeper penetration, and continued cost efficiencies across the portfolio. And beyond this ambition, we see meaningful additional upside supported by our early-stage pipeline and our ability to bring new molecules to market with speed, quality, and global scale.

Let's [indiscernible] care provision business, Fresenius Helios, where we are elevating patient care with next-level digital tools and AI. Investing in digital and connected solutions are central to our strategy, driving better outcomes, higher efficiency and staff satisfaction, and ultimately, an improved patient experience. With the two largest private care networks in Germany and Spain, we are uniquely positioned to shape data-driven, patient-centric, and cost-efficient health care. During REJUVENATE, we are steadily expanding digital technologies across our hospitals, leveraging our distinctive strength, direct patient access, rich clinical data, and deep medical expertise.

A prime example is Casiopea, our digital health ecosystem in Spain, now serving roughly 9 million active users and capturing nearly all medical activities to create what we would call a seamless and connected patient journey, leading to positive results for patients in terms of medical outcomes and experience. Beyond this, we are rolling out AI-supported diagnostics, including rapid stroke and colon cancer detection. These initiatives make care smarter and more patient-centric, improving outcomes and reducing treatment times.

Our systems consistently deliver medical quality above market benchmarks. In Germany, for example, we improved yet again, with now 92% of cases in 2025 exceeding market average quality performance. Combined with best-in-class clinical teams and state-of-the-art hospitals, Fresenius Helios continues to be the top choice for patients seeking exceptional care. Our strategy of upgrading the core and scaling our platforms is moving Fresenius into higher growth, higher value segments, unlocking new profit pools, fostering innovation-led growth while lowering exposure to price pressures.

For Fresenius Kabi, this is exactly what Vision 2026 set in motion. Over the past 3 years, Kabi has delivered meaningful top-line expansion and substantial margin improvement, enabling us to raise our EBIT margin ambition to 17% to 19%. This progress has been fueled by a stable and resilient pharma business and the increasing contribution of our 3 growth vectors: Biopharma, Nutrition, and MedTech.

Biopharma continues to scale rapidly. Nutrition is contributing accretive growth with targeted new product launches, while MedTech is benefiting from continuously improving margins and strong demand for our [indiscernible] products. Together, these businesses are expanding our mix towards more specialized, higher-value segments with structurally strong underlying economics.

At the same time, our care delivery platform, Fresenius Helios, provides predictable, stable cash flows that strengthen our balance sheet and support disciplined investment in our growth areas. That being said, Helios needs to step up even further to set up the organization for sustainable, long-term operational excellence and success. While Kabi is leading with structural enhancement and margin expansion, Helios is not yet delivering in line with our expectations. Closing this gap is a clear management priority for 2026 and beyond.

REJUVENATE is now fully underway, and when you look at where we began our #FutureFresenius journey just over three years ago, it's clear how far we've come. We continue upgrading our core, modernizing our operating model, streamlining our footprint, and lifting execution across all businesses. It's the principle of keep doing what we are doing, but doing it even better.

Equally important is how we can scale our platforms. This is where REJUVENATE truly will unlock value. Across our biopharma, MedTech, and care provision platforms, we see opportunities to step into new value pools that build directly on our strengths in critical and chronic care.

Our anchor remains the patient, often the patient in the ICU, the OR, the ER, or in other high-acuity settings. And we are exploring selected adjacencies that means expanding to what lies left and right of the core, broadening our impact along the care continuum. This includes strengthening and renewing our portfolio, pursuing selective in-licensing, expanding geographically, such as the U.S. rollout of our parenteral nutrition, and exploring high-value adjacencies in specialized injectables, next-wave biosimilars, Nutrition innovation, and connected MedTech solutions.

These measures are elevating our performance and position Fresenius for being stronger, more innovative, and more relevant, also in terms of growth and value creation in the years ahead.

With that, I'll hand it over to Sara.

Thank you, Michael. A warm welcome to everyone joining today's call. We closed 2025 with an outstanding fourth quarter. Our performance accelerated across all relevant KPIs. Q4 delivered an excellent top line with 9% organic growth, driven by both operating companies. EBIT grew by 13% at constant currency, fueled by Kabi's continued powerful operating performance and the expected strong acceleration [indiscernible]. Our bottom line momentum further accelerated with 16% growth in core EPS. This reflects the combined effect of consistent operating strength and substantially lower interest expense. Q4 saw a sequential increase in tax rate due to provisions in income tax liabilities. For the full year, the tax rate was well in line with our expectations. My highlight of the quarter is our operating cash flow, which exceeded EUR 1.3 billion.

Our strong cash conversion supports the deleveraging, bringing us well within our self-imposed target range of 2.5 to 3x net debt-to-EBITDA. Overall, we are looking at a very successful financial year, 2025. We have delivered an excellent operating and financial performance in [indiscernible] of rising geopolitical uncertainty and despite meaningful macro effects. Our results and phasing also played out just as we set out at the beginning of the year. I am very proud of the entire team for Fresenius for this achievement.

Kabi delivered their strongest quarter in terms of absolute revenue in history, achieving 10% organic growth. Growth vectors were up 16% in Q4. With 97% growth, Biopharma continues to be the main driver here, fueled by further ramp-up of Tyenne and the uptake of Otulfi. Nutrition grew 5% organically. Strong underlying growth in European and international markets more than offset the impact from Keto volume-based procurement in China. MedTech delivered 5% organic growth, showing a consistent performance across all regions and segments. In Pharma, organic growth of 2% was driven by Europe, with good volume and price mix. In the U.S., volume growth more than compensated for pricing pressures. Argentina hyperinflation, the resulting price effects benefited the top line in Q4, but significantly less pronounced than in the previous year.

Kabi's EBIT margin for the fourth quarter reflected planned investment and year-end effects as expected. Against these effects, and despite the Keto impacting China, Q4 margin remained on prior year level, demonstrating the underlying strength of the business. This was driven by ongoing growth factor margin expansion, reaching 15.4% in Q4, as well as by a meaningful improvement in operating leverage and productivity gains.

Q4 was an outstanding quarter for Helios, in line with the phasing we had laid out. Organic growth was very strong at 8%, significantly exceeding the structural growth bands. EBIT margin stood at an excellent 11.7% at the top end of the structure margin band. [indiscernible], as expected in our phasing.

Helios Germany grew 6% organically, driven by good admission growth and positive pricing. EBIT growth significantly accelerated both on a sequential and year-over-year basis. This was due to several well-flagged effects. The significant ramp-up of the performance program during Q4, the 3.25% surcharge for publicly insured patients in November and December, and a softer prior year base as Q4 represented the first quarter in 2024 without energy relief contributions to EBIT.

Helios Spain reported excellent organic growth of 11%, driven by increased activity levels and year-end payer settlements. The EBIT margin of 15% reflects some year-end effects as well as the good top-line development. Our excellent operating cash flow stand out as a highlight for me for the quarter, but also for the full year. Both operating companies maintained strong cash conversion during Q4, with Kabi continuing their disciplined approach to CapEx and net working capital, and Helios very successfully driving receivables collection. As a result, our cash conversion rate for the full year stood at 1.1 for the second year in a row, a direct outcome of our stringent cash focus. Helios cash conversion rate of 1.2 in financial year 2025 underscores its characteristic as a reliable cash generator for the group. Kabi, at 1.0, was also perfectly in line with our cash conversion ambition.

Last 12-month free cash flow includes proceeds from the FMC divestment in Q1 2025, as well as from the pro rata sale alongside the FMC share buyback. In total, these proceeds amounted to around EUR 560 million over the last 12 months.

We enter 2026 with strong foundations and remain focused on our priorities. This is what we have on our financial agenda for the year. As in the past, we continuously review our ambitions, building a stronger, more agile, and innovative Fresenius. A more mature organization allows us to leverage financial flexibility from our sustainably strengthened balance sheet. We will do all of that while maintaining a strict focus on returns and bottom line.

The Fresenius Financial Framework is a living framework that evolves with our business and that provides a yardstick to measure our performance against our ambitions. 12 months ago, we raised and narrowed Kabi's structural EBIT margin bands. Today, we are further raising the bar to 17% to 19%. Consistent margin expansion over the past years, the rigorous execution on structural productivity, and the overall increased level of maturity gives us the confidence to do so.

Looking ahead for 2026 and beyond, we expect continued progress, driven by several key factors. First, further margin improvement in our growth vectors as our strategy unfolds. In 2025, they expanded their margin by another 130 basis points. Second, Kabi's ability to innovate and successfully launch new products across all business units will provide the basis to drive the next leg of profitability. Third, we remain focused on enhancing our operating leverage and are targeting further productivity gains across the business. The pharma segment will continue to provide a resilient foundation, and we expect it to maintain a margin of around 20%. By 2026, we expect an EBIT margin of 16.5% to 17%, based on our strong operating momentum.

Fresenius had made remarkable progress in strengthening the balance sheet. In two years, we've reduced net debt by around EUR 3 billion, representing around 1/4 of our net debt. This has been achieved primarily on an organic basis, driven by a stringent focus on cash and a strong earnings performance. Having regained financial flexibility, we now have strategic optionality as we advance our REJUVENATE agenda.

What does that mean in terms of capital allocation? Firstly, we remain committed to investing for long-term profitable growth, upgrading our core and scaling platforms. This includes, for example, enhancing production capabilities, strengthening our digital infrastructure, fostering R&D and innovation, while also investing strategically in our pipeline and portfolio. This is guided by strict return and disciplined capital allocation requirements. Our CapEx outlook reflects that with around 5.5% of revenues for 2026, up from 4.4% last year.

Second, we remain committed to delivering attractive shareholder returns and propose a dividend of EUR 1.05 for full year 2025. This represents a 5% increase year-over-year, with distribution at 37% of core net income towards the upper range of our [indiscernible].

Last, but certainly not least, our priority is maintaining a strong balance sheet, keeping our leverage well within the target range of 2.5 to 3x, and staying fully committed to our investment grade rating. This means strong discipline on capital allocation and cash conversion.

REJUVENATE sets us on a clear path for future profitable growth to generate value to our stakeholders. Two KPIs, which nicely complement each other to measure this, are EPS growth and return on invested capital. On EPS, we continue to see strong momentum, delivering another year of double-digit bottom-line growth, with Core EPS increasing 12% for the full year.

Three things are driving this. First, during Revitalize, we have built our muscle of operational excellence and efficiency, which we continue to exercise. In 2025, the organization again delivered substantial EBIT savings. At Kabi, productivity gains have become part of the DNA. Helios also delivered on its performance program in 2025, which was initiated just 12 months ago.

Second, with REJUVENATE, we are further building our muscle to identify and leverage growth opportunities. This also explains our resilience in 2025 against the tough macroeconomic backdrop. Third, our focus on cash and deleveraging reduced our net interest expense by more than EUR 100 million last year.

Regarding return on invested capital, this is deeply embedded in our financial framework, financial steering, and beyond. It introduces a long-term perspective, given its slower moving nature. In the last two years, we've seen a 140 basis points improvement, demonstrating that we have transformed Fresenius into a return-focused organization. This focus will not change. Despite increased financial flexibility, we will carefully evaluate all investment opportunities with the same rigor, ultimately, with a view to delivering long-term value creation.

Now turning to the guidance for 2026. We expect 4% to 7% organic revenue growth for the group. Core EPS growth at constant currency is expected to be within the range of 5% to 10%. Core EPS is defined as earnings per share before special items and excluding any contribution from our stake in FMC. Given we have structurally strengthened Fresenius' earnings base and have become a more mature organization. We believe the time is right to move from EBIT to a Core EPS growth guidance. This change demonstrates our commitment to shareholder value creation, while aligning with how the market values the company.

Before I finish, as an additional help, let me share building blocks of our outlook and indications for the segment. Kabi will continue to build on its strong operating momentum in 2026. We are expecting a ramp-up over the course of the year as rollouts and launches are being executed. The key to effect in China will annualize from Q2 onwards. The 3.25% surcharge for publicly insured patients will benefit Helios until end of October '26. Throughout '26, we will continue to make targeted investments aligned with our REJUVENATE agenda.

We are operating in a rapidly changing geopolitical and macroeconomic environment that is giving rise to a new world order. This shift is driving greater complexity in global regulation, supply chains, and trade frameworks. We are closely evaluating the potential implications of the recent Supreme Court ruling on tariffs, but since the situation is still developing, this cannot be fully reflected in the current guidance. Our focus is proactively preparing for the future while managing short-term uncertainty.

Thus, for Kabi, we expect mid to high single-digit organic growth and an EBIT margin between 16.5% and 17%. For Helios, we expect mid-single-digit organic revenue growth and an EBIT margin between 10% and 10.5%. As a result, EBIT margin for the group is expected to be around 11.5%. Based on a much stronger balance sheet and with some refinancing needs in mind, we expect that interest expenses remain in line with the previous year. Our tax rate is expected within the range of 24% to 25%.

FX effects will have an impact on our 2026 results, assuming spot rates as of December 31 remain unchanged, this would have a negative effect of around 1% on reported revenue, EBIT, and Core EPS. As the year continues, we look forward to keeping you updated on our progress.

And with that, I hand it back to Michael.

Yes. Thank you, Sara. Now let's take a step back and look at health care systems and the dynamics of health care systems more structurally. Globally, health care systems are under increasing pressure. They were built for a bygone era. The structures that worked well in the 20th century can no longer fully address the challenges of the 21st, from demographic shifts and rising chronic disease to workforce shortages and a more fragile supply chain environment.

In this environment, health care is increasingly recognized as critical infrastructure. Reliability, security of supply, and resilience are becoming just as important as efficiency and cost, a shift that strongly supports Fresenius' positioning, and we need to continue to invest for future success. We play a system-critical role through essential medicines, generics and biosimilars, and health care infrastructure that expands access to high quality, affordable care and supports health care systems sustainably.

Our diversified portfolio and local-for-local operating model provide meaningful resilience and flexibility. Our global footprint and production network help limit exposure and strengthen health care security, particularly in key markets like the U.S.

At the same time, innovation is key. Building a digitally enabled operating system is essential to improving both efficiency and outcomes. We're investing in digitalization, AI, and next-generation capabilities to enhance clinical decision-making, streamline workflows, and give time back to care teams, enabling systems to do more without proportionally increasing costs. We also believe in a pragmatic approach to innovation, rooted in an ecosystem, trying new models, scaling that works, and embedded successful solutions into everyday care. This mindset allows us to modernize the operating model while staying focused on quality, reliability, and disciplined execution.

As we look to 2026 and beyond, our focus is on building a resilient health care franchise for the future, leveraging scale, innovation, and resilience to deliver sustainable, profitable growth and long-term value for patients, partners, and shareholders.

And with that, we're happy to take your questions.

[Operator Instructions] The first question is from Hassan Al-Wakeel from Barclays.

I have a couple of questions, please. First, on Helios, your guidance assumes around EUR 100 million to EUR 150 million of incremental EBIT at the midpoint of the range in 2026. On our math, this is less than the incremental benefit from the surcharge. Can you help us understand the offsets, associated costs, as well as how you think about the margin trajectory, excluding the surcharge in 2026, also in 2027, as this rolls off? Second, for the group, your flat margin guidance sees much of the expansion at Helios and Kabi eroded by a corporate cost line, which is increasing quite significantly, again, at the midpoint.

Can you talk through some of the projects that you have planned here, and the duration of some of these projects, and where you see the corporate cost line approaching, over the next 2 to 3 years?

Yes. Thank you, Hassan. I'll start with your second question, and then we'll lead to the second one, and Sara can give you the details then on the Helios as such, but this will be an embedded part of an overall answer because I guess, your, especially second answer, is on many people's mind. Let me first of all, start by really the big picture. We had a very strong finish in Q4, and we are very confident going into 2026 and beyond with everything we have in place. I'll go into detail on that one, but that one is the base case. We are operating in an environment which is facing unprecedented change. We had the Supreme Court ruling last week, we see other regulatory topics in the U.S. PBM reforms.

Don't forget, when there is a, let's say, a new geopolitical world order, other geographies are also taking measures. There's a lot of uncertainties out there, but still, we feel very well positioned. This uncertainty obviously needs to be also somehow encountered, not in terms of money or a number, but as the sentiment, going with our very strong business into '26 and '27. When I look at '26, and I get your math on Kabi is there, Helios is there, what is on the corporate cost line? I think this is way too much a technical view. We need to come by the business, and then we'll see how that translates into a technical model.

When I start with Kabi, by the way, we didn't guide, these are indications or these are numbers from our Financial Framework, which is a performance management tool. The outlook is on the group. When we say 4% to 6% and 16.5% to 17%, if they were to achieve that, they have plans and measures and actions behind that ambition, you need to consider we are now in an innovation-led phase. A lot is dependent on the top-line development. Not like a couple of years back ago, the IV generics and solution business only. We have parallel shifted the growth trajectory, 200, 300 basis points to 6%, 7% in the last couple of years. That means innovation needs to come and the sales needs to be done.

In Kabi, I would say, if I would choose a header, this is a volume game. The volume needs to come, the volume which will then turn into operating leverage, and the volume comes through launches. The volume comes through working and converting, where we have frame contracts into pull-through. The volume comes by implementing the supply chain, which then can cater the contracts. A lot of things need to happen. We'll probably go business by business later on. Biopharma, nutrition is coming with 12 launches during the course of the year. We have increased our capacity in generics and in nutrition. Now, that capacity is ready to cater the markets, but it still needs to hit, let's say, the accounting books until we need to journalize revenue. When it then does hit the revenue, then you will see operating leverage.

Let's assume, which is not our base case, the revenue is only moving up slowly. This management team is ready to take cost management items and go into the cost. That would be not the desired outcome, but we are ready to do that. Depending on that one, we will see where Kabi lands, and we could do the same story on Helios. You get to a corporate cost line, which either is also reflecting, let's say, the challenge which they have and back on the operational business, and then we'll take it from there.

On the Helios, maybe?

On the Helios, let me try and also give you a little bit of a more comprehensive answer on this, on this one, and maybe ground you in where our jumping off point for 2025 was, right? If you look at the DRG and pricing related jump off point for 2025, that was roughly 5.9%. Going into 2026, that DRG inflator is set at 2.98% -- from 5.9% to 2.98%. Then comes the surcharge for 10 months of 3.25%. If you calculate that roughly, we're landing at around the same level in terms of price tag compared to 2025, with one exception, and that's more a technical effect, that part of that price increase will sit under other income, i.e., just below the revenue line.

If you look into 2026, you assume the price tag roughly the same. You look, obviously, our cost base is going to increase as well. There's nothing out of the ordinary and nothing out of the kind of exaggerated. Still, what you will see is some wage increase. We will also need to cater for the increase in activity by increasing some of the staff levels in pockets here and there. You will also see on the other side, on the complement to that the company program obviously is also yielding some benefits. That there is a company program, 2026, where we continue to seek structural productivity also on the Helios Germany side. Overall, that for me is a very balanced perspective going into 2026.

There is one other topic, if you look at it, there is hybrid DRGs. They were introduced in 2024. It's fair to say there is another leg of rollout in 2026. There will be shifts between the traditional or classic DRG into that hybrid DRG. Overall, we remain very confident that with the indications we have given you in terms of margin improvement for Helios overall, we will hit this. Now, obviously, you would also want to know 2027, how that will all unfold. We're starting off with a DRG of around 3%, we know that the 3% for this year, that was a very specific situation.

Normally, you have that most favored nation clause, which is always saying if the DRG is set as the higher of either the increase in cost in the hospital or what you see in terms of increase in the rates of the public health authority insurance plans. For 2027, we expect that most favored nation clause to be reinstalled. Outside of that, there has already been the confirmation that the state-based case value will be reimplemented, and that's 1.14%. If you want, that is a little bit half of the delta between the most favored nation price point for 2025, which was the 3%, or precisely the 2.98%, and the 5.17%.

Again, 2027, I don't expect that there is a lot of disruption in the system itself. Bottom line, while there may be movements in the buckets of remuneration, we expect to see there is price increases in the system. There will also be some cost increases in the system. We continue to focus onto our company program, for 2026, I think we have given you a really nice margin expansion perspective on Helios.

The next question comes from Oliver Metzger from ODDO BHF.

The first one is a very quick one. Does the exceptional strong growth of the 97% Biopharma consist of any one-off effects or pull forward effects, which could mean that Q1 might be softer from an absolute perspective? Second question is about the growth composition in Helios Germany. You reported an increase of 4% for the inpatient treatments, which is a great confirmation that you gain market share. Simultaneously, I see that the ambulatory treatments grew just by 1%, which appears, to a certain extent, counterintuitive to the overall trends to treat more patients outside the clinics.

It would be great to hear your thoughts about this, and also how you think about the ambulatory trajectory for next year, also in the context of the digitalization and efficiency activities you're doing, and also the lower described invasiveness.

Yes, Oliver, I'll start with your Kabi question on bio. Well, they had a very strong Q4. Particularly by the U.S. I was very pleased to see that under the special distribution agreement with CivicaScript, we did see the first revenue postings. That was very high. If you have a higher jump-off point, you already are a little bit, how should I say, more uphill when it comes to Q1. In Q1, there may be in the neighborhood of, I don't know, EUR 6 million milestone payment year-over-year, which will be lacking from MAP Science, but that is only a Q4, Q1 kind of topic.

Over the biosimilars business is expected to grow again meaningfully in '26. Obviously, there had been a high growth rate in '25, which was 50%. You can't get to 50% anymore. This incremental high growth, I wouldn't call it flat now, but it has a different incremental number. You know, there are lots of molecules. We have Deno, we have Uste, we have Tyenne and many others. As I said, the pull-through and everything has to come. Don't forget, this goes a little bit, again, to Hassan's question. For example, on Tyenne, other competitors are also now coming to market. Actually, two. One of them, I think the TPP is inferior. I would say the other one has a strong TPP. Whilst we have enjoyed exclusivity, now it's more defend exclusivity, that all has to work. That one on the biosim.

The Helios?

Yes. Happy to take the Helios. I think for us, if you look at the business and where the revenue come from, the vast majority of that is still inpatient. The number I focus on is really the inpatient, and there, the 4%, as you said, is a really nice growth trajectory. You can see that Q4 accelerated in terms of activity in the hospital. For now, and also going into 2026, while we expect Hybrid-DRG to take a higher share, we expect that the traditional DRG still remains the lion's share in terms of contribution to our revenue. Now, how the Hybrid-DRG will fold out in terms of how many cases will be moving, I think, that we will see as the year unfolds a little bit.

There been, let's say, hernia repair or urology, which have been on the menu already in 2025. They got some broadening in terms of existing indications. Then there were some new, like cardiovascular interventions. I think for 2026, what you will see the main part is coming from the inpatient, hospital setting.

The next question comes from Veronika Dubajova from Citi.

I have two, please, and apologies if I've missed this a little bit. Just let me go back to your comments around what happened in Germany and sort of maybe the slower progress that you're making on the structural works there. If you can maybe talk through what is it that's not going to plan and what you need to do to improve that. Just a quick question, if I can ask around the Kabi margin on the corridor. If I look at the '17 to '19, 80% to 85% of the business is already or, you know, given the guidance you've given us, should be operating at 20%. How should we be thinking about the progression in medical devices?

Yes. Maybe just to put the statement into perspective, I think that fits very well in what Sara outlined on the overall '25, '26 Helios kind of buckets they are moving. I absolutely get it and that these are really a lot of moving buckets on the regulatory front, and we'll do the utmost that you understand everything where it moves from A to B. What we were emphasizing in the speech on Germany is that the efficiency program, which by the way, did not only have cost benefits, it was an EBIT program. The EUR 100 million was actually executed, we would say, to plan. They brought home what they have been saying.

Having done a few of these programs myself in the past, I looked at it. I started the first one in 2001. Usually you also sometimes actually have a buffer operationally, internally. What has happened is, with the DRG inflator, what Sara said, there was a change. That's why I call it a wash in San Francisco. They took the lower end, and then they have to surcharge. At the end of the day, it would have been the same if they had taken the higher end. It was a more complicated way of doing things.

That being said, we want the business to be resilient enough to counter these effects, therefore, we want them to double down on their efforts to structurally improve the whole cluster strategy, for example, to further build on consolidating the administration things. Then obviously to manage the patient flow in order to manage the case mix, because we have not talked about the case mix, so Sara did talk about BVR, that case mix is also one element which contributes to the margin. Kabi, well, it's nice, the math you did with the 20%. I don't know how you get there because you got the growth vectors and you got the pharma business.

I got to say, looking at last year, I'm very satisfied that we saw improvement from all the businesses. If you are hinting that there's a culprit with MedTech, over the last 3 years, meaningfully improved their margin by a couple of 100 base points. Where you may be too aggressive on the optimistic side, maybe on the biosimilars business, because don't forget, this is also a highly competitive business, where it's not a generics, but it's similar to generics. Once you hit the market, it's going to be very competitive and the prices are contested by competitors. That's why the strategy was being fully vertically integrated. Okay?

The next question comes from Hugo Solvet from BNP Paribas.

Congrats, Michael, on continuing the journey until 2031. That's a great news. First question on biosimilars. I'm curious to hear what's the feedback from your latest discussion in Washington on biosimilar development timelines and adoption initiatives. Have discussions accelerated as we approach the midterm elections, and what are your thoughts on the risk that significantly lower costs could lead to more competitions or lower the barriers to entry? Second, maybe more for Sara, but on pharma, is there any idle capacity cost that we should think about for the Wilson ramp-up in 2026? On price pressure in pharma, has it been deteriorating a bit more or stable in recent months?

Yes. Thank you, Hugo, also for your kind words. Look, on biosim, that's why I was mentioning it. I think all we see, particularly in the U.S., is headed in the right direction. You had the FTC enforcement, and you had, you have the PBM reforms. At the end of the day, this is the whole intent, to have a more transparent, fairer, market-driven approach, actually to increase competition so that end customers, end consumers get the lower price. That does not necessarily mean when I say get the lower price, that immediately there's incremental price pressure. Today, the whole system via PBMs is based on high list prices and rebates, and the co-pay of the individual patient in the U.S. is also based on that list price.

The incentive is the higher the rebate on Part D. The higher the rebate is, the more, business there is for the middleman. If you change that system to the net effective cost or the net pricing, then this will change. This is been experiencing already in contracts where we had this direct channel, direct health plans, special distribution deals, on branded ones, and so on and so forth. We feel that is headed into the right direction. Also, this whole topic about interchangeability and also getting rid of phase III clinical trials.

That being said, I'm not. This is the whole, I would say, deregulation effort of the administration.

That being said, I'm not worried that this will now attract a lot of competitors into the market, because at the end of the day, you, as I always say, you will only survive if you have a fully integrated value chain and if you have a good pipeline, if you are great in developing molecules, great in manufacturing at the most competitive cost, and great in distribution channels. You need to be able to orchestrate all of that one. If somebody wants and tries to play in that market, you still have some entry costs on patent litigation. On average, people say it's depending on the molecule, EUR 30 million or something like that. You need to invest already into that one. I think it's headed into the right direction.

Maybe because I, before I hand it over to Sara, maybe on Veronika's question on the margin for Kabi. What I would also emphasize is that we are investing also in innovation, and that is what you need to do. I was actually surprised when an investor in San Francisco asked me, "What is the leakage in the business?" When I asked, "What is the leakage?" She said, R&D. R&D is not the leakage. R&D is securing your future. If you don't have R&D and molecules in the next 3, 4, 5, 6, 7, 8, 9, 10 years, you're going to be out of business. You also see investments going into OpEx.

Yes. And now happy to take the question on U.S. pharma. You heard Michael saying it's a volume game, right? It's fair to say in 2025, we have seen a price pressure, and 2025 was a volume game. Let me qualify that a little bit. You also know that we have taken on stream, the extensions in Melrose Park and Wilson.

If you look at Wilson and Solutions, for example, we have seen quite a nice ramp up in 2026, and we have seen a 2025, and we will continue to see a nice ramp up in 2026, adding to that volume ramp up and that volume topic, which we will continue seeing from '25 into '26.

If you talk about price pressure, per se, Q4 was probably a little bit more pronounced the rest of the year, '25. If you look at Q1, however, we see that price pressure kind of lifting a little bit and being less tense than it was in Q4. Overall, however, we don't expect that to go away, and we believe that it is a, whatever, single digit, middle single digit, price pressure point we will be seeing for 2026 as well. How can you then be successful? It's, like Michael said, it's portfolio and pipeline, and in 2025 we've been quite successful with our 15 launches and building on that one, but it's also the reliability of supply. I think there we also struck really nice wins, and winning awards from our customers. In the end, it's the volume which needs to come and the customers which need to be happy with your supply and your reliability and your portfolio, and that's how you manage the price.

By the way, why are we confident on that one? There is market share to be gained, and we have seen market share gains on solutions because we're talking about Wilson and solutions. We want to pick up more. Again, that then needs to work. If that works, then it gets volume. Market is there to be picked up because as you probably know much better, many customers may want to diversify their supplier base.

The next question comes from Philip Omnou from JPMorgan.

Just a quick one on Helios Spain. You guys mentioned seeing some benefit from payer settlements. Just wondering, are you able to share a bit more color on that? Perhaps give us an idea of the year-on-year impacts that you saw on revenue and margins.

Yes. Happy to do so. Maybe again, let me take a quick step back, because if you look at Q1 in particular, I think it's always worth looking at the full year rather than to go quarter by quarter. What you will see is you have a relatively seasonally weak Q4. There is a Q3, sorry, there is a holiday period. People, patients tend to be not around, but also, other people tend to be not around, and that is being picked up with high activity levels in Q4. Q4 tends to be the strongest quarter. If you look at the margin in Q4, for Q4 '24, that was high and there was a really significant growth year-over-year from '23 to '24.

Now if you look at '25 again, you see that Q4 is a really strong quarter with a really attractive margin and also on top line. Part of that, also in '24, but also in '25, is payer settlement, is final negotiations on topics. If you wish, the prior to year-end clean up in many ways. You will have in Q4 a little bit more year-end effect on the Q1 side. This is nothing new. I think you can see that has been a consistent theme. It's not for me, if you so wish, a one-off is something which you see on a more regularly evolving base.

The last question comes from Falko Friedrichs from Deutsche Bank.

Two questions, please. Firstly, with the, your leverage ratio now at 2.7x, so comfortably inside your target corridor and your clear dividend policy, what are your capital allocation priorities for this year, and could bolt on M&A already be an option for you in 2026? Second question, could you briefly remind us on how you were exposed to tariffs last year? More in general and completely irrespective of whether they're going to increase or decrease now after the Supreme Court ruling.

I'll start with the second one. Then Sara, which I think she already outlined nicely in her speech, but Falko will repeat it again. Not so sure on the M&A, we'll answer that one, but the general principle. On the tariffs, first of all, I'm grateful that you mentioned it, because yes, we also had tariffs last year. We were not completely immune, particularly on the, let's say, MedTech arena. The Biopharma, pharma, parts of nutrition were exempted, but that was also a process of being in a very constructive dialogue with policy decision makers. Therefore, if you, if even if you take, a like for like, then you would have a full year annualized tariff impact going into '26.

How that then changes with the new ruling, we will have to see.

Yes. And if you look at capital allocation priorities, you already mentioned yourself the dividend and shareholder return, as well as the strength of the balance sheet. It's fair to say, over the last years, we have gained that financial flexibility, that with REJUVENATE, we can now also step up in terms of investing into our own growth. We have more opportunities than we probably have funding for, but I think the important thing is, with REJUVENATE, it's the growing our platform and upgrading our core, and that really means investing into R&D, investing into innovation, investing into our digital backbone, but also investing into portfolio and pipeline. The line between organic and small inorganic for me is a little bit blurred.

If you think about pipeline, you can develop yourself the molecules, and then you spend money on R&D, but you can also in-license, and then you spend money outside. I think for me, the more important point is that we spend the money in order to safeguard future profitable growth and in order to safeguard returns for the long term. We will decide project by project, with a view on those two, whether it makes sense to invest more into our funding, our own innovation, or whether we go to the outside and in-source certain things. Overall, with REJUVENATE, we have kicked off the next leg, if you so wish, of fostering that investment. It's also reflected in a higher CapEx of 5.5% of revenue.

Just to be clear, it's not only CapEx where we will need to spend and invest. A lot of it is also OpEx going into R&D or going straight into the cost line as well.

Martina, can we take one last question of Anna Ractliffe, Bank of America [indiscernible].

Sure.

This is maybe a bit of a topic change, but I was curious a little bit about MedTech. I appreciate the commentary that Ivenix is driving a decent amount of the MedTech growth in 2026, but I wanted to see how much share gain is embedded into that estimate, and how do you see Ivenix growing compared to other areas that have been strong, like the Nomogram and cell and gene therapy? Just any color on those moving pieces would be great.

Yes. Yes. First of all, let's say the market and the customer feedback is phenomenal on Ivenix, and it is ramping up. Where I always keep the horses a little slow is this is not for the overall company or even for overall Kabi, the, let's say, financial catalyst driving the top line. When I look at, first of all, the contracts we won, the quality of contracts we won, this is just amazing. Also, the customer feedback we received, then the installations, which are ramping up, and then obviously, concurrently, the cost per pump, which is being in-sourced, if you so wish, this is all going well.

This is a huge market, and there's a lot of share to be grabbed, but we don't want to be, in brackets, too greedy at early innings to grab too much share, whilst we need to still stabilize the rollout. We have very, which is good, luminaries, but by the same token, demanding customers, for example, Mayo Clinic, which means there is a lot of connectivity work into the system, primarily Epic, in their system as well. The second thing is that depending on which hospital you have and what kind of procedures they have, for example, if they have transplant, then you need other or more sophisticated sets. The portfolio of sets needs to also follow the installation of the pumps, which is good because that's recurring revenue, by the way.

This is all, that's why I'm giving you the qualitative answer, working well. The Nomogram was great. It started, Q3, Q4, and we expect that this is one of the drivers for them for '26. I would say even a bigger driver, given that we're talking about once, exactly as Sara said, the R&D was spent. Now, if we sell that, the larger, bigger gross margin comes in, and we hope to enjoy the Nomogram on an annualized basis.

Ladies and gentlemen, that was the last question. The over to Michael for any closing remarks.

Yes. Well, thank you. Thank you for your questions. We thought these are very fair questions and a very good conversation in these really unprecedented times. Again, what it means that we go into innovation, into adjacencies, is that what you have seen in the last three years. We have shown you how much the growth vectors. Which was the innovation of the former years, if you so wish, have contributed in terms of share of EBIT and even on the top line, EUR 500 million, it's EUR 0.5 billion with 20% margin. In a way, we're trying to move, and that is what scale platform means, get into these new value pools, which then cater exactly this incremental revenue and margin and margin expansion.

Therefore, you need innovation and investment in every shape and form, whether it is in licensing, whether it is partnerships, whether it is R&D, whether it is bolt-on acquisition. That is what we're playing because we need to be sustainable in the long term. The second thing is, I think, or I hope we explained a little bit the moving parts on the guidance. If you have an innovation-led growth and you have increased your capacity, the load and the volume on the capacity for operating leverage needs to come. We are confident that it will come because many things are backed by contracts. We have great visibility, so the margin for error there is not huge, but it can -- customers pull through when they pull through.

Supply chains need to work when they need to work, and this is at the beginning of the year, where we may be having exactly a stance of what needs to come, where we will update and upgrade you once we get there. When we are seeing that on that path, we're making good progress on the top line, we will qualify the outlook even more and/or adjust.

With that, thank you very much.

We want to thank Fresenius and other participants for taking part on this conference call. Goodbye.

Good morning, everybody. I'm David Adlington. I head up the research group for JPMorgan in London for Medical Devices and Services. It's my pleasure this morning to introduce Michael Sen from Fresenius SE, and then we'll follow up the presentation with some Q&A. Michael, thank you very much.

So good morning, everybody, and thank you, David. Thanks for having us. I think it's a wonderful opportunity to come together at the JPMorgan Healthcare Conference. We've been talking about that one that it is the industry gathering, a lot of stuff going also around the conferences, meeting periods. But I would also say there could not be any better time for this conference. And that's why I'm delighted to say, "We're committed to life", which is our brand claim. And even the title introducing a health care company even so it might sound very easy is exactly what we're talking about. It's about health care. We got everything in our portfolio. We have our own system as some people say. So we have got hospitals. We have pharmaceuticals. We have medical technology. We have a lot of innovative products and services. So we're really encompassing the entire spectrum.

And why do I say it's great to come together because timing is everything. What do I mean with timing is everything? Timing is everything because the world is changing, as we know. Therefore, it's great to come together here in the U.S. I would say there's a new world order. But what really emerges as a theme globally is that health care is a key element for resilience, for wealth and also for security.

So that being said, after the safe harbor statement, if we look at the great trends, which all are known to everybody in that -- at that conference, but these trends are emerging and are being magnified as we speak, and we dissected it into these 3 trends, the longevity trend. Yes, people are getting older, but the chronic disease patterns are rising. We're getting older, but not healthy getting older. There will be a massive, massive workforce challenge. And obviously, most systems, especially in Westernized country, are inefficient. That is well known.

By the same token, a lot of things are happening in science, in regulatory framework exactly addressing this one. And Fresenius, that's why I said it's a health care company, is very well positioned. And why did I say timing is everything because the journey we have been embarking on for the last 3 years is now paying off that we are in a position to actively seize these trends and to really contribute solving these challenges.

Let me give you just a very concrete example. If you say health care systems are so inefficient. If you look in the U.S., 90% of the drugs prescribed are generics, but it's only roughly 10% of the cost. So that means if you are a generics provider, and we are a highly specialized IV generics provider, if we dissect the numbers and the data, we do not seem to be the problem. On the contrary, we are the solution. For example, in the U.S., which is in drug shortage, to play a vital role and essential role to addressing exactly this challenge. So from this very big flight height, you can go to very, very concrete examples.

And then timing because our company now is a much stronger, a much more focused and more simple company. And this is the makeup of our business. On the left side, you see what we call Fresenius Kabi. This is, I sometimes call it, the industrial side, the product side. On the right-hand side, it is our services business, our care delivery business, which is the largest European hospital chain, the largest chain in Spain called Quirónsalud and the largest chain in Germany, Helios. And then the 4 businesses, very individual pharma and solutions, biopharma, biosimilars, I think a theme which is getting a very positive undercurrent, I would say, currently, nutrition and MedTech. And all in all, this is the focus portfolio we've been working on the last 3 years, and it has yielded real good outcome, which I'll tell you in a minute.

If we double-click and this is the industrial business, the Kabi business, we call it base business and growth vectors. I labeled this at some point in time, 3 plus 1. All these businesses, as you can see on the chart, are in very good market positions. All markets are growing, and all businesses have potential for further incremental organic growth. You see the sizes depicted on that one.

And the pharma business, IV generics and fluid solutions. And that is very important because solutions is a very sticky business, which helps us get into the conversation with customers and then come with our very broad IV generics portfolio. You see #1 in IV drugs and then #3 in fluids, also in this country, gaining traction, gaining market share, very stable business. The growth is, as it is 2% to 3% in the market, but it is highly margin accretive if you see the 22% and highly cash generative, which gives us the stability. It's not a cash cow. We keep investing into that business. This is exactly the business where we, also with the current administration here in the U.S., are in conversations saying, this is the essential part we cater to this country as in other countries. And then we have the so-called growth vector they grow higher.

Nutrition, 46% market growth, and we probably are at the upper end of how the market grows. We have an enteral and parenteral nutrition business. It is -- this is the numbers for the first 3 quarters. For the full year, it's roughly a EUR 2.5 billion business, growing between 4% to 6% and highly, highly margin accretive.

Medical technology business, which is primarily infusion therapy and transfusion therapy on the transfusion side, for example, very innovative fields like cell and gene therapy. We disclosed the press release only this morning, how we work together an ecosystem. And on the infusion therapy side, it's obviously pump and solutions around that. And that very well fits together with the pharma IV generics, pharma and fluids. So customers here can buy an entire bundle, an entire solution.

Biopharma, the latest kid on the block, it's primarily biosimilars. And when I was standing at the conference a couple of years back, it was an investment case. It was an investment case where we're only spending R&D. There was -- if you only spend R&D, there's no profitability. There was hardly any sales. We didn't enter the market in the U.S. Now we are, probably in 2025, a little shy of EUR 1 billion. In 2026, we're going to reach the EUR 1 billion in sales. It is obviously driving incremental profit, by the way, so are the other growth vector businesses. But this one, obviously, at a larger scale when you take the percentage points of the incremental margin expansion.

And I really feel also in these 3 days, David, that there is a very positive undercurrent with also other companies that the adoption, the diffusion of biosimilars, for example, in the largest market in the U.S. is picking up. You see the sign new target. Right in December, we had an educational session on biosimilars, and we said until 2030, we're going to double our revenues on that one. If it's roughly EUR 1 billion in '26. Well, it's going to go to EUR 2 billion or more. And it will probably then have the potential to reach a profitability of 20%. Now the key theme has been, is that too conservative? This was based on the current pipeline we have. This is a short glimpse.

And if we go to the hospital business, our own system, Germany largest player, Spain largest player. And they are very 2 distinct businesses. And I think, meanwhile, the market also gets closer to these businesses because these are highly regulated businesses as they are care providing businesses, care delivery businesses. But that highly regulated business is a very stable business. It's a resilient business. It's a stable business. And if you manage to keep the margin at the high level where they are margin leading and grow organically, this will automatically lead to earnings growth. And obviously, the earnings here equal very much cash earnings.

And in Germany, if one thing stands out is and we will still drive structural changes there in Germany and increase efficiency. But if you measure our hospital against all quality standards in Germany, by more than 90%, we are leading the pack. So this is all about clinical outcome and quality. And Spain, I dare to say also in the U.S., Quirónsalud is the most innovative hospital chain in Europe. This is a hospital chain, which is building on the digital platform. Now it's about the adoption of AI. We have a lot of agents in action here. And therefore, you see also the difference in margins. Spain is really a high-margin care delivery business. And as I said, earnings equal cash earnings, and you see the size of those 2 businesses.

Now the last 3 years, and this is just a proxy, we've done a lot. I was asked yesterday, what has changed at Fresenius. We called it Future Fresenius because everything changed. But here, this is just a proxy how we cleaned up the portfolio to get to a better performance to focus ourselves as a management resources and create a much simpler company. This is what we did. We deconsolidated Fresenius Medical Care, went out of a lot of businesses. And this is what it did to the financial outcome.

Q1 to Q3, 6% growth, EPS growth of 14%, net debt-to-EBITDA at 3.0. And you also see where we came from. And then at that time, 3 years ago, net debt-to-EBITDA was going already towards the 4 and beyond. Operating margins were going down. You see the operating growth -- organic growth rate was going down. And so there was a focus of not only cleaning up the portfolio and taking out costs, which we did very successfully, but in all these individual business concurrently focusing on innovation.

And this is what it has done. If you look at the -- especially the growth vectors, that's why they were called growth vectors. It was about incremental innovation in med tech, in nutrition and then biosimilars commercializing this one, launching this one, getting it to the market, you see the contribution of the growth vectors here. I won't go the slide in detail, but you see that strategy seems to be working out also in numbers. Obviously, this is what you like. This is what we like that the share price has developed quite nicely in the last 3 years also vis-a-vis the entire sector because we believe this is the individual path we took on the equity story. And now we are ready in this new world, in this new environment to grab even more opportunities.

This is also important because 3 years ago, we also changed our incentive system. The Management Board in their long-term incentive, we are incentivized on the share price. We introduced share ownership guidelines for the Management Board. So we have to hold equity in a specific amount. And now we are introducing that for the entire leadership team. Now you say this is very normal for any any high-performing company. Yes, it is, but it was not the case in our company. So we introduced this 3 years ago. That's why we also love that development.

Now this is what you get when you manage everything. You start from the top line. You saw how organic growth has been going up. Then we have been focusing on margin expansion. So operating margin went up concurrently, and we have our IR team with me, but also our CFO. So we were very adamant on asset management or net working capital, on CapEx, on cash flow delivery. That's why also cleaning up the portfolio by then focusing concurrently on the interest rate line item.

And you see in '23, this was the year -- the first year we took over, EPS growth -- even though operating income was going up, EPS growth was going down. And the reason was only in that year, we had year-over-year a drag of more than EUR 300 million on the interest rate line item. We turned that around. So last year, it was 14% EPS growth. This year, for the first 3 quarters, it's also 14%. And even we don't have the full close yet. We still need a couple of days. But I think it's fair to say that it will be double digits. So this is significantly how we drove the bottom, bottom line by concurrently being very disciplined on capital allocation, capital deployment, and that's why returns have also going -- have been going up and that's why you see the ROIC without the goodwill being also nice.

Now last year, when I was standing here, this is our clear plan. This is our clear direction for the entire company for all managers, leaders, and this is not just management consulting BS. This is really something which guides us. And now we are in the rejuvenate phase. Rejuvenate phase means we can play offense. Rejuvenate phase means the incremental revenue, the incremental margin expansion is driven by new products. Rejuvenate means we have a lot of new leaders and managers who have been coming in, in the last 2, 3 years with a lot of industry domain expertise. Rejuvenate means we want to upgrade the core. We defined what the core is, those 6 businesses. And we say to our team, keep doing what you've been doing, but do it even better. So in essence, that means execution.

By the same token, now we are in a position to scale our businesses. When you will look at our balance sheet in a minute, you will see we now have firepower in the balance sheet. We now have even monetary items by deconsolidating Fresenius Medical Care. We now have the maturity in the overall organization to scale the platforms. That does not necessarily mean we go immediately into huge M&A endeavors. We will be very focused on capital deployment and capital allocation. But it means we can allocate and deploy incremental capital. And for me, incremental capital deployment means R&D, means CapEx, means partnering, means in-licensing, means maybe also bolt-on M&As to scale the platform and then elevate the performance. And this is what we're going to do.

At the industrial business, in order to scale that, it is all about the pipeline. The pipeline on the pharma business, on the biopharma business. And when we talk about nutrition, it's about formularies. So we call it the pipeline is the lifeline. So this is working endeavors in R&D, in development, but also on in-licensing. At Helios, and particularly in Spain, it is all about digitizing and implementing AI. And then, obviously, when you do this one, you can capitalize on trends, which we outlined also on the right-hand side. And with that one, we can double down on our mission, which we believe is really, really, really essential these days. It's about cost-efficient medicine, innovative therapies and access to health care.

And now I'm open for Q&A.

Great. Maybe just to kick off here, a big picture question. You've been CEO now for what, just over 3 years. You had a lot to do both strategically and operationally when you joined. Firstly, on the strategic side, have you now finished with divesting or even closing businesses down? And then with the balance sheet, you've touched on it in the presentation, but with the balance sheet getting back to a healthy position, should we start to think about adding to the business again? And if so, what are you thinking about from that point of view?

Yes. On the big picture, if you say strategy as in portfolio, I think the big, big portfolio moves as in the focus, it's done, there may always be smaller things when we exit maybe a country with a factory or exit a hospital or something like that, which we do currently in Germany that we clean up the structure. But the bigger portfolio move, this is the focus. This is the core. That's why it is called the upgrading core.

And as I said, we are now with the Rejuvenate in a much better position. Last year when we were here, the target on the leverage was 3 to 3.5 and the company has not been able to get into that target range for 7.5 years. So last year, we managed to get in there. And concurrently, we tightened that range and said the new range is 2.5 to 3. So our CFO in the first row, if she's smiling, it will probably look like that '25, we will be in that very target corridor. And that is what I meant. This gives us room to deploy incremental capital for these core businesses.

And as I mentioned, the incremental capital is for me, R&D. It is CapEx when we talk about, for example, growth CapEx with new factory lines. This is one example. The other one is obviously also in-licensing when we talk about our pharma business, when we talk about our biosimilars business, you saw on the biosimilar side, we did in-license last year also vedolizumab. We in-licensed Eylea, aflibercept and concurrently have 6 molecules in the market. So yes, there is room for incremental capital deployment, which needs to yield returns.

Perfect. And then just to clear off another question I get asked quite a lot when I'm out on the road seeing investors. Maybe you could just point towards the synergies between Kabi and Helios and could you see a situation where the businesses are further split?

Look, if you look at the business, the group as it is, I mean, there's always this, let's say, theoretical question on synergies or our business is better off alone. But the group is the group and had a balance sheet. And that balance sheet, the net debt to EBITDA was at the height. I think it was 4.2, 4.3. So you need businesses to generate cash flow.

So the logic of this focus, which we currently have was to have businesses from a strategic point of view, which are in growth areas. All of these businesses are in growth areas, have a leading position, have a runway for growth and have enough barrier for entry, if you so wish. And all of these businesses have that. The second thing is all of these businesses should have and have the potential for organic growth. And if you then come from the hospital business, which is in revenue quite sizable and say the earnings are stable earnings, very stable earnings, equal cash earnings, you already get a very stable base as in cash flow.

On top of that, you then have the big IV generics business. It's not a high-growth business, but it's a very resilient business. It's a very essential business. Again, very cash generative. So that already gives you a huge bedrock to build on in the balance sheet and then the growth vectors are the increment. And we are currently and will be in the next foreseeable future, not in a phase where any of the businesses holding back the others in terms of outpacing growth. So we have, with the new balance sheet, enough room to deploy capital to even further grow revenue, earnings and returns.

Perfect. Okay. Let's move on to Kabi, which in itself is still a relatively broad business with pharma, nutrition, MedTech and biopharma. Maybe before we dip into that, I'm just wondering in terms of what you're expecting in terms of impact on volumes in the U.S. from the changes we're seeing in Medicare, Medicaid and the expiration of ACA subsidies this year and into next year?

Well, all these businesses primarily in IV generics and fluids since we are also highly vertically integrated, which is one of our key propositions, that's why we have a cost competitive position, is that we are banking on volume. And we will be also banking on volume. We've got our management team also sitting here in the back from the U.S. in the U.S., and we will play a vital role. The role we play in the U.S. is that we have a very, very broad portfolio. We know by a fact that the country is still in drug shortage, and we cover roughly 70% of the FDA essential medicine list, which is we sometimes call it drug shortage list. And therefore, we play an essential role.

And concurrently, also at this conference, visiting customers, the breadth of our portfolio makes us so relevant that you don't have to always interact with onesies, twosies companies. And then we have a whole supply chain here in the country. We're manufacturing roughly 70% of what we sell here, here in this country. We call it Mak in America. And therefore, we will see volume growth in IV fluids, particularly. We opened up a plant 1.5 years ago in Wilson, North Carolina, and the capacity utilization just goes up.

Perfect. Let's move on to IV drugs and fluids. It's one of the more mature business within the Kabi portfolio. You obviously got the growth vectors in addition. It was a business that enjoyed several years of super margins a few years ago because a lot of competition were out. They've now come back, margins have come down, but still pretty healthy. It is, by definition, a more commoditized area of the business, how do you feel about the balance between not very much growth and some pricing pressure and how you can grow or maintain margins over time?

Yes. It is a commoditized business. But if you look at the impact it has on the whole clinical workflow, it is a highly relevant business. I mean last year, when there was the hurricane here in the country and then the competitor had to -- had his challenges with one factory, you saw that immediately almost on the entire planet, there was a shortage of IV fluids because capacities were directed towards the U.S., that meant there was a shortage in Europe and so on and so forth. And there is almost no surgical procedure you can run without IV fluids. Think about gastroenteral surgical prostate procedures. On average, you need 9 liters of fluids. For procedure where in Europe, you can charge roughly EUR 9,500 per procedure. I don't know what you charge here, probably more. And therefore, it is highly relevant and the players you have in the market are at capacity. And therefore, it is a very important and a very sticky business and helps us to complement the entire portfolio.

Perfect. Let's move on to the growth vector at Kabi. Maybe firstly, on nutrition, you pointed towards kind of 4% to 7% annual growth there. You're already #1 market share by decent chunk. How do you continue to drive that level of growth?

That's why we dissected these businesses into these individual business lines. Nutrition is an innovation-driven business. The generics is -- once it hits the market, the prices only go down. That's the nature of generics. In nutrition, it's all about innovation. It's about new formularies. It's about going into new segments. We launched a lot of products in 2025. That's why you saw nice growth rates. Despite the Chinese Keto effect, we have been growing very nicely. Actually, without the Keto effect, on a comparable basis, probably the nutrition business would have grown by 8%.

That means new formularies hitting the market, new segments. We launched products in the pediatric space. We broadened the portfolio in terms of taste. We broadened the portfolio in terms of clinical use for high-calorie usage and dosage forms. And you get more and more clinical and scientific evidence that nutrition plays a key role on the clinical pathway and leads to better clinical outcomes. For example, on oncology treatment, if you get the night right nutrition, you get to better outcomes, and that obviously helps the business. And geographically, you know we can still grow quite nicely in the U.S., for example.

Perfect. I mean you mentioned Keto there, which has also been a challenge for your Chinese business. Are there any other areas we should be worried about VBP or any other Chinese initiatives to take cost out of system?

I think it would sound like a broken record when I say, look, my stance on China did not change for, I got to say, now almost 2 years. This is not a short-term market we will be banking on. It is still, let's say, in transition. Midterm, long term, obviously, the fundamentals also speak for an attractive market, but VBP is there to stay. This is the way how this country is going to procure and get to cost savings, which doesn't mean you cannot cater other segments. You can. But obviously, then you need to differentiate because on the VBP, you don't need a promotional sales force. On the other ones, you need one. You can change your tiering of hospitals. You can drive innovation, which is then only maybe later being a part of VBP. But this is how the market is changing.

Therefore, in 2025, we saw primarily by Keto contraction, the market is, for us, it's roughly 8% of the overall kind of thing. But in '26, we will expect some growth on the nutrition side because we are opening a factory in Wuxi on three-chamber bags. But by and large, fundamentally I do not change my mind on China.

Perfect. And then change gears to MedTech point towards higher growth at 8% to 10%. From the outside, that's sometime to think that is like a more mature business than with some stronger competition. How do you grow at that sort of rate with that sort of backdrop and competition?

No. Well, this is also by innovation and new products. You know that we have the Ivenix pump out there. This will be, let's say, a meaningful contributor to the incremental growth we expect in 2026. And this is a very innovative pump. It's the most innovative pump in the market. It's a smart infusion system on a large volume pump.

By the same token, other functionalities and applications, for example, software, we have the -- on the plasma side, the Adaptive Nomogram, which is a software which helps you to optimize plasma collection in plasma collection centers. Q3, Q4, very nice sales and margin on that one. We expect to have the full year contribution in '26. And then, again, little steps like this morning where we announced we are partnering on cell and gene therapy, where everybody is working on optimizing the whole production and value chain of cell and gene. These are all these little steps because it's a smaller business, which then yield growth.

Perfect. And then just on Ivenix. I mean that's a business you acquired some years ago. And the rollouts -- I just wondered how the rollout is progressing relative to your expectations and what's been the biggest challenge you face there.

Yes. The rollout is according to our expectation. Also the challenges are according to the expectation. Three years ago, when we acquired that, that was more or less a start-up business. They had a fully registered pump, FDA clearance, but no industrial scale. So we decided to industrial scale that. That means we took over the production because the cost per pump at that point in time was way too much. But if you professionalize that, industrialize that, we in-sourced the manufacturing, we built out the professional supplier network, and this is all according to plan. So in the last 3 years, the cost per pump came down tremendously and will further go down.

Then, how was the reception in the market? It is actually outstanding because it's an innovative pump. But now expectation to the challenges, we always said we do not want to place too many pumps too fast in the market in wanting to build out an installed base because like with every MedTech product, when it's new, there will be some challenges, there will be some child sickness patterns, and we had some. And then if you have a too large installed base out there, it is obviously then getting costly.

In our case, you could do that with software patches. We have a very, very demanding customer, which is good, which is Luminare with Mayo Clinic because they're interoperability, their integration into their IT system keeps us on our toes, but that means if you can satisfy a customer like that, you can satisfy many other big players in the U.S. So everything is going according to plan, including the challenges.

Perfect. And then on biopharma, you mentioned the education event just before Christmas. You pointed towards doubling revenues by 2030 and taking margins to 20%. Margins in '25 are going to be sort of mid-teens-ish, up from just about positive in '24. You're getting a lot of operating leverage in that business as your fixed costs and your revenue is growing very fast. The 20% on the margins in 2030 doesn't seem particularly stretching given that high level operating leverage. Is that just you being conservative again? Or should we be thinking about some cost or some mix impacts?

No. I think in this case, we really need to differentiate. Unfortunately, that industry and that business is not a financial model. That industry is still in early innings, as I call it. I sometimes call it, it's at the beginning of the S-curve. In the U.S., biosimilars have only picked up in the last 2 to 3 years. EU had a little bit of a head start of 6, 7 years, but only picked up here. And only look at what we've been learning in the last 2 years how to commercialize this in this country. Two years ago, there was only one molecule, adalimumab for Humira, EUR 22 billion market, a lot of players going in there and everybody thought if you're not on the national formularies of the 3 PBMs, you're dead. Then we said, let's try other sales channels. So we managed to contract directly with health plans, the EVO deal with Blue Cross Blue Shield, California.

Now meanwhile, we have 6 molecules in the market with TYENNE, a totally different molecule. TYENNE, peak sales originated sales, EUR 3.5 billion, but we are first to market. And the incremental sales, obviously, is driving the profitability. And then now we have ustekinumab and denosumab in the market. And on ustekinumab, we have that very special, we call it, special distribution deal with Civica. Civica has more than 100 million lives under management and a lot of health plans. So this was, again, a totally different commercial model. Then on the regulatory front, the U.S. is probably going to get rid of the Phase III clinical study, which is a positive signal for me. So we will expect more dynamics in the coming years, and therefore, it's very hard to have a crystal ball.

And the second argument would still be next to the operating leverage, you need R&D. Because one thing also to be a sustainable, we want to be a biopharma powerhouse player that means full vertical integration, you need a pipeline. And for the pipeline, you need R&D development or in-licensing, which is also then an investment, but also keeps other players maybe out of that space.

Perfect. You mentioned that the change in the regulatory environment in the U.S., that could potentially reduce your costs and time to market. But at the same time, it does the same for potential competition. How are you feeling about the balance there between time to market, but also the impact on the longer-term market dynamics?

I'm not so worried about the competitive dynamics. For me, this is just the positive sign, the regulatory environment that this new modality, the biosimilar, which is an innovative therapeutic modality for oncology and autoimmune, for example, that the regulatory environment goes into the right direction. I wouldn't overemphasize that this already has such an impact on the competitive dynamics. It's still, if you want to go into that space, it already starts with the patent litigation on the originator, and that already costs you $30 million to $40 million -- roughly on average, $30 million to $40 million per molecule. So this is already the first barrier of entry.

The second thing is even though you don't have a Phase III clinical study, your data in your clinical studies beforehand need to be robust. So the capability of developing molecules because this is not a generic, this is a biologic, right, developing molecules needs to be there, and we believe only a few player can do that, and we want to be a powerhouse.

Perfect. And then switching gears just to Helios. I just want to touch on Germany in the time we've got. 2025, you had some margin headwinds as the energy subsidies, support roll off -- rolled off. We actually got some tailwinds going into 2026, particularly the surcharge. I think it's EUR 4 billion surcharge across the industry. How should we be thinking about that top line -- those top line tailwinds into '26? And how much of that is likely to drop through into the margin?

Yes. Let me take still the opportunity to reflect a little bit on '25, even though you don't know the numbers yet, but you probably -- you have the consensus or your report or what have you, going into 2025, we were facing a lot of headwinds. There was the energy relief on the German hospital, which you just mentioned. We always said it's in the neighborhood of roughly EUR 150 million headwind. The key to effect the VBP in China headwind, we set roughly 80 basis points. And then on top, even some tariffs and FX and then look at where probably the number will come out, it doesn't look too bad.

Now going into '26 on Helios Germany, I would not go fully overboard with the surcharge and everything. I can make it short because of time, I would say it's a wash. There is a 12-month surcharge by the same token, the Ministry of Health has taken EUR 2 billion out of the system again, which he wants to save in the hospital system. So basically, it's in a wash. So I would just take the normal DRG-inflator, which is more at the lower end. And then we have to work on the case mix and still on our efficiency program. So not going overboard as in volume and price and then revenue and drop through.

Don't get too excited on the margins, David, I think is what you're saying.

No. Nope.

Perfect. And then finally, we had obviously, Helen here yesterday giving a more cautious outlook for Fresenius Medical. Obviously, you still retain your stake there? Any latest thoughts in terms of your thoughts of the stake?

No. We are a shareholder, nothing more. It's an investment company. If you look at the -- I think it's more important to l at the history of what we've been doing with medical care. When we started 3 years ago, it was almost thinkable beforehand that Fresenius would be there without Medical Care, then we deconsolidated that one. After deconsolidation, only -- it was only March last year that we already reduced our stake. Then Medical Care said they're going to do a share buyback. We said we're going to go in lockstep to keep the reduction. And then I said it's an investment company. So -- and I even said this is a monetary item for our scaling, our core business.

By the same token, management has a clear plan. I obviously saw the reaction of the market in the last 2 days. It is clear that the volume, whereas the volume growth, I think this is what you've been asking. This is what we've been asking. But by the same token, innovation has been coming up with HVHDF and so on and so forth. So there's value creation potential there. This is always the trade-off, how much value creation is there opposed to immediately selling off or something like that, which we didn't do. We didn't do 3 years ago. And that's why we could -- if you look at the exchangeable, the exchangeable was locked in at, I think, EUR 53 price per share.

Perfect. Great. And that takes us to time. Thanks very much.

Thank you.

Hello, everyone. Welcome to the Inaugural Conference Call and Webcast as part of our new Meet the Management series. Today, we're kicking off with a deep dive into Biopharma. The presentation was e-mailed to our distribution list earlier today and is available on fresenius.com.

On Slide 2 of the presentation, you'll find the usual safe harbor statement. Unless stated otherwise, we'll comment using constant exchange rates or CER. In preparation for this call, we asked our investor and analyst research panel about the priority expectations, forgive me.

In short, you told us that you wanted more details on pipeline insights and competitive position, including time lines, scale of pipeline opportunity and differentiation relative to peers. You also asked about the growth drivers and long-term value creation, including greater transparency, revenue and margin impact with a clear growth road map, which we've addressed in the presentation and supplementary materials.

Today, I'm delighted to be joined by Michael Sen, Pierluigi, Sang-Jin Pak, and the broader Biopharma team. We will now take you through our ambitions and the agenda on Slide 3 in more detail.

Today's call will last approximately 90 minutes with the presentation taking around 45 minutes with the remaining time for your questions. To give everyone the change to participate, please limit your questions to one to two. We can always come back for a second round, if needed.

Lastly, let me please take the opportunity to thank Otto, Felix and Mara from the Investor Relations team, plus the broader Biopharma team for their significant efforts in preparing for this event.

And with that, I will now hand the call over to Michael. Please go ahead.

Thank you, Nick, and welcome to everyone joining us today. Fresenius' powerful mission and vision motivates us every day. At the heart of what we do lies an unwavering commitment to providing the highest quality in clinical care, ensuring that every patient receives the best treatment possible.

Our vision propels us forward. We strive to be the trusted, market-leading healthcare company uniting cutting-edge technology with genuine human care. Combining both allows us to shape therapies that push the boundaries moving healthcare to new heights.

I am particularly inspired by the dedication of Team Fresenius, who makes this mission and vision a reality. Together, we will continue to innovate, improve and expand our reach to the benefits of patients globally.

The global healthcare sector is growing, and it is undergoing an unprecedented transformation driven by technological advancements, demographic shifts and evolving patient needs. We, Fresenius, are in a fantastic position to address these major structural challenges in healthcare. As we face a significantly aging global population, people are spending more years in poor health. Consequently, healthcare spending in terms of GDP will increase across geographies.

Let's take the U.S. as an example. Healthcare spending is headed in one direction only, projected to crossing the $5 trillion mark in 2024 based on CMS data. At an expected growth north of 8%, this is the biggest increase we have seen in decades.

Now let's dig a little deeper. Although generic and biosimilar prescriptions account for 90% of prescriptions in the U.S., they account for only 17.5% of the country's spending on prescription drugs according to the Association of Accessible Medicines.

In other words, costly brand name products account for the bulk of pharmaceutical spending. The generics and biosimilars industry bring costs down. Hence, we are part of the solution with our relevant products and services.

This is future Fresenius, a company that can capitalize on exactly these trends I just laid out. It is a much stronger, simpler and focused healthcare company stronger by focusing on the core and deepening our businesses. Our core is two-fold.

On the, what I call, product side, the four businesses within Fresenius Kabi, IV Generics & Fluids as the big Generics & Fluids as the basis and underpinning business and then the three attractive growth vectors, Biopharma, Nutrition and MedTech.

And on the Care Provision side, our Helios businesses, where we hold leading market positions with our hospital networks in Germany as well as in Spain. This new setup enables us to benefit from changing healthcare needs and translates this one into great financial traction. The focus of today is on our ever more relevant growth vector, Biopharma.

From my talks with many of you over the last quarters, I am convinced that today's event comes exactly at the right time. We will give you more clarity on our positioning and our ingredients to win in this highly attractive market.

We have started the next phase, Rejuvenate, and this phase has kicked off with great traction and focus and will guide us for the next few years. This phase is all about upgrading the core, scaling our platforms, to elevate our performance. This means bringing new products and innovations to market, focusing on the needs of patients and customers and infusing fresh energy into our leadership and management teams to deliver further value, expand ecosystems, and create more opportunities.

Biopharma is at the core of our Rejuvenate agenda, positioned as the next frontier for growth and patient access. As a leader in innovative healthcare products and highest quality patient care, we are expanding our biosimilars business to delivering value for payers and patients. We made the deliberate decision to leverage Biopharma as the next frontier for growth and patient access.

First of all, because of its dynamic and highly attractive growing market, we see that the adoption and patient access is ever increasing quarter-by-quarter. At the same time, the importance of biologics is just evident. As just laid out, payers are under significant pressure to save, and we are playing right there with our portfolio of biosimilars.

Annual savings in the EU and U.S. are expected to grow to EUR 100 billion by 2030. We are thus part of the solution to reduce global healthcare spending, a fantastic position to be in, combining relevance with economic success and good news for patients everywhere.

Biopharma is an absolute success story for Fresenius. Past the acquisition of only a handful of molecules from Merck, we derisked the business and built a fully vertically integrated powerhouse.

We have now 11 marketed products across 9 molecules in a globally balanced setup. Our differentiated portfolio and R&D function, combined with state-of-the-art manufacturing and an excellent commercial function gives us the right to win in that very marketplace. This is translating into excellent financial progress and also momentum.

In the first 3 quarters, the Biopharma business contributed more than EUR 600 million of sales with a growth rate in constant currency north of 30%. Profitability-wise, we have seen already last year that we were EBIT breakeven. And this year, we are already looking at the structural EBIT margin for Kabi from below.

Fantastic financial progression. And as you will see later by Pierluigi and the team, there is more to come. Thus, we will allocate capital in this attractive growth vector to spur further growth. To be clear, not via a multibillion-dollar transaction, but much rather, we will focus on further in-licensing capacity extension and in-house R&D developments. That is what I meant with upgrading the core.

This is our renewed management team. This is part of our Rejuvenate agenda, infusing fresh blood, fresh pair of eyes into the organization, such as with Sang-Jin, who joined us from Samsung as President of Biopharma, a great team that will lead you through the presentation over the next hour.

So in conclusion, Fresenius is well positioned to seize opportunities in the highly attractive Biopharma market. Our Biopharma asset has the right ingredients to win over the next years. With a strong presence in Biopharma underpinned by robust secular growth trends, we are committed to sustaining our momentum and driving long-term profitable growth and of course, shareholder value. These dynamics present a unique opportunity for Fresenius to deliver innovative solutions that improve patient outcomes, while helping to advance cost-effective healthcare systems.

Our strategy remains centered on serving patients with the best products and being a trusted partner to healthcare providers worldwide. By allocating capital to our Biopharma growth vector, we will spur further profitable growth. As focus now turns to 2026 and, of course, beyond, we are committed to leveraging these strengths to deliver long-term sustainable growth, creating value for patients, partners and, of course, shareholders.

Now let me hand it over to Pierluigi and Sang-Jin.

Thank you, Michael, for the introduction, and hello to everyone attending today's call. It is a great opportunity for me to provide you with more details about our Biopharma exciting business and the opportunity ahead.

I will now give you a short overview of what we have already achieved, but most importantly, why we are convinced about our future success and our confidence in delivering 2030 ambitions.

Afterwards, Sang-Jin and the team will give you more details on the attractive biosimilars market and will elaborate on our unique fully integrated setup with the right levers to win and ultimately create value.

Let me move to the next slide. And before we go into the specifics of Biopharma, I want to go back to the CMD we had in May 2023, when together with my team, we shared details on the Fresenius Kabi performance turnaround. I remember quite vividly that at the end of the presentation, the first two questions were about our confidence and ability to execute such a transformation.

Looking back, we now see a tremendous track record. Not only have we demonstrated rigorous operating execution, but also consistent positive results, meeting or exceeding expectations quarter-after-quarter. And I believe that we have proven to you that we can deliver on our commitments.

If you look at the 2023 CMD targets we laid out, we delivered both on revenue and EBIT expectations for Biopharma. As a reminder, we previously said that our ambition was to multiply our revenues by 3x or 4x by 2026 and achieve EBITDA breakeven in 2024.

In fact, we multiplied sales by approximately 4x versus our 2022 base year, 1 year earlier, and we achieved EBIT breakeven in 2024, and that's, I believe, it's quite great performance. And therefore, over the past 3 years, Biopharma has played a pivotal role in driving the strong and positive performance development that we saw for Kabi overall and for Fresenius.

Kudos to my Biopharma team for these great achievements and naturally, a key driving factor behind the performances has been the quality of our new Biopharma leadership team.

We selected a new BU President with Dr. Sang-Jin Pak. And we strengthened the overall leadership team with important external hires who brought significant experiences from across the sector. We now have a winning team who I believe is ready to deliver on our newly announced ambition.

Let's have a look at our great financial progression. For Fresenius Kabi overall, our EBIT margin trajectory has been excellent over the last 3 years. We improved our Kabi overall margin from 13.8% in '22 to 16.6% in the first 9 months of 2025. And while pharma is the resilient part in our portfolio, we delivered a strong increase in the growth vectors profitability. We improved, in fact, the margin significantly from 8.5% in 2022 to more than 15% in the first 9 months of 2025.

More specifically, Biopharma delivered the most significant margin improvement. We invested significantly in our pipeline, reduced cost and advanced our technical network. We are now reaping the benefits of our strategic and capital allocation decisions, and we continue to scale our business to make it fit for the future.

As mentioned, with the new leadership team, we significantly advanced the maturity level of the organization, while also delivering successful regulatory approvals, launches and commercial successes across the globe.

So, why do we think that we have the right to win in this exciting market? Because along the three pillars of the Biopharma value chain, we are very well positioned with a distinctive, competitive and integrated value proposition. Firstly, we have a differentiated and robust portfolio with a proven R&D engine. We aim to significantly expand our pipeline with 15 potential new medicines, enabled by our two strong in-house R&D engines at Fresenius Kabi and mAbxience.

In addition, we will supplement our pipeline through strategic in-licensing opportunities, ensuring we have the best mix between internal and external opportunities in order to deliver the best possible return on investment. We also scale in development in our platform approach enable fast to market and efficient commercial execution across multiple new medicines.

Secondly, we manage a fully integrated and cost competitive manufacturing network, which is anchored on mAbxience. Progressively integrating and internalizing drug substance manufacturing to mAbxience ensures supply reliability, quality and increasing cost competitiveness over time. Through this integrated setup, we can scale efficiently and expand mAbxience coverage through targeted capital allocation and future investments, tech transfers and network optimization. And our demonstrated ability to manage this complexity represents, in my view, a meaningful differentiation and a source of potential competitive advantage over the long term.

Lastly, we have balanced global commercial access with an established presence in more than 35 countries worldwide. We'll continue to build on our strong Europe heritage by leveraging our commercial infrastructures and payer access, but we'll also expand the coverage in the U.S., and we'll keep leading selectively in international markets such as LatAm, where we have leading positions in 2 out of the top 3 markets, namely Brazil and Argentina. And this broad footprint is a strength and ensures also resilience for future long-term profitability growth.

There is also one specificity that I believe represents a significant differentiation compared to our competitors. That is our presence -- global presence with our three business units across the globe. And that gives us recognized reputation and strong presence that we can also leverage when it comes to Biopharma. And together, these three pillars define how we compete and how we believe we'll keep winning in this space, and they also provide the structure for the presentation that we'll follow.

Now we go to the important slide where we are stating our ambition for 2030. So we are now increasing the ambition. And today, we are announcing our new 2030 ambition, which is, first of all, we aim to double our revenue from today's base. And this will be driven by further launches and by increasing also penetration and market share with our medicines.

And second, we are aiming to achieve an EBIT margin of around 20% by 2030. And this is broadly equivalent to our highly profitable pharma business. And the main lever for this margin improvement are to keep driving continuous improvement in costs, but also to keep scaling our portfolio in globally attractive margin.

With that, I hand over to Sang-Jin and the team to share more details and give you more color on how we plan to transform this commitment into a reality.

Thank you, Michael and Pierluigi, for setting the stage. It's great to be here. We have the strength, capabilities and levers to double our sales and double the number of molecules in our portfolio by 2030. When we look at the building blocks to reach this ambition, the path is clearly laid out. The significant increase will be largely driven by the continued strength of our existing and highly relevant business.

The core engine is the compounding growth across our nine in-market molecules: tocilizumab, adalimumab, denosumab and ustekinumab are driving a large share of this excellent momentum. These products are still in the ramp-up phase with accelerating strong adoption curves ahead, expanding access and increasing share across key markets. This gives us a consistent, reliable foundation for growth with great visibility ahead.

On top of that, we are constantly adding new launches, which are already in late-stage development or secured through confirmed and licensing. This includes aflibercept, vedolizumab, etanercept, and nivolumab. These are significantly derisked with clinical development near completion, scale-up transfers and tech transfers underway and commercial pathways clearly laid out and defined.

In this context, we see a CAGR of around 15% through 2030. The portfolio is already built. The assets are funded and the highly motivated team is rigorously executing. Beyond the 2x ambition, we see further significant upside potential. Our early-stage pipeline, including six new assets already in development and fully financed will hit the market beyond 2030.

Hence, we are confident in delivering not only on our short-term ambitions, but also on our long-term growth momentum. This is how we double our portfolio, double our revenue and reach above 20% EBIT margins by 2030.

Looking at the highly attractive market environment, we see strong tailwinds supporting our ambition. These are exciting times. We are moving into the strongest LoE cycle the industry has ever experienced with a 6x market expansion to EUR 180 billion by 2035. Even in the years 2026 and '27, which globally have a lower number of LOEs, we expect to continue our double-digit growth trajectory. We operate with a globally diversified and well-balanced footprint across Europe, LatAm and the U.S. Hence, we naturally capture LoE windows that are staggered across different regions. This minimizes our exposure to temporary years with lower LoEs in certain regions.

For the short term, we plan meaningful launches, including aflibercept and vedolizumab, which are expected to maintain our great momentum. For the early 2030s, we see further significant upside potential beyond our 2x ambition.

The market momentum is not only driven by LoEs. Biosimilar adoption has entered a new phase of momentum due to favorable regulatory shifts. Adoption is accelerating globally. In the U.S., we finally see a significant acceleration driven by increasing payer familiarity, stronger incentives and broader acceptance by prescribers and health systems.

Importantly, most molecules continue to grow for several years after launch. We are also seeing this pattern across our own in-market portfolio. Tocilizumab is still gaining traction each month; adalimumab remains a stable anchor; and ustekinumab is accelerating with interchangeability designations. These adoption curves give us sustained tailwinds from assets already launched, a major contributor to the predictability and durability of our growth outlook.

We are seeing a great performance of our Biopharma franchise. In fact, we are the fastest-growing top 7 biosimilar player. This momentum is fueled by our consistent and broad-based execution across our nine marketed molecules. Being the fastest growing among the largest competitors underlines two points for me.

First, our operating model works end-to-end from R&D and manufacturing to commercial execution. Second, we consistently gain market share in highly contested mature markets, which is one of the strongest validators of our competitiveness.

What differentiates us is that we operate as a fully integrated biosimilar powerhouse from drug development to drug substance and drug product manufacturing, all the way to commercialization in more than 35 countries. We have built a platform and reached critical scale for future success.

Today, we run 15 pipeline products, 3 drug substance sites and a flexible network capable of producing millions of units across vials, pre-filled syringes and auto-injectors. Because we manage the full value chain, we control quality, cost, supply reliability and speed. Our ingredients to win in biosimilars are a strong and differentiated portfolio, cost-leading manufacturing and a world-class commercial execution. Our entire operating model is built around these three pillars, and this is why we're consistently delivering today and will also do so in the future.

We have established a broad and competitive portfolio with 11 marketed products across 9 molecules. Importantly, the vast majority of the molecules were developed in-house, demonstrating the strength of our R&D engine.

Our brands now span immunology, oncology and endocrinology, showing that we can both launch and scale across very different therapeutic areas. Adalimumab remains an anchor; tocilizumab is accelerating strongly; and denosumab is differentiated with a pre-filled syringe offering.

Pegfilgrastim, bevacizumab, pembrolizumab and rituximab complement this space and add diversification across markets and channels. This breadth, combined with proven execution, gives us a strong platform to double the portfolio by 2030 and maintain sustained growth well beyond.

Looking from the portfolio to the supply side of the business now. In biosimilars, drug substance represents roughly 3/4 of total manufacturing cost. Because we have internalized the DS manufacturing through mAbxience, we operate from a structurally advanced cost base compared to the broader industry.

Vertical integration allows us to optimize productivity, scale efficiently and continuously reduce costs through process improvements. It also makes our supply chain more resilient and agile, an increasingly important differentiator as competition intensifies and payers put more pressure on pricing. This manufacturing advantage is one of the key reasons why we are convinced that we are very competitive and will win in highly contested markets like the U.S. and Europe. This will ultimately lead to further expanding margins toward our 2030 ambition.

Our commercial model is balanced and well diversified across Europe, LatAm and the U.S. In Europe, we have a deeply established direct sales presence in more than 20 markets, coupled with strong payer access and tender excellence. This allows us to consistently secure leading positions at launch. In LatAm, we are the leader in Brazil and Argentina, supported by strong regulatory environments and local manufacturing. These markets also act as incubators for early launches, enabling us to build real-world evidence and execution muscle ahead of global rollouts.

And in the U.S., we are scaling rapidly with high double-digit revenue growth year-over-year 2024 to '25. We are applying innovative approaches in contracting and distribution and are deliberately expanding our footprint in a market that will represent more than half of the global biosimilar industry by the mid-2030s. This global balance significantly derisks our revenue and enhances our growth resilience.

The biosimilar landscape is evolving quickly. Regulatory frameworks are shifting literally as we speak with Phase III waivers accelerating timelines and market dynamics changing as odd substitution and payer-driven contracting intensify cost pressure. We have prepared for this shift ahead of the wave. We already achieved approximately a 40% reduction in cell line and process development time, giving us a meaningful speed advantage.

Our cost leadership driven by DS internalization and a platform approach ensures we remain competitive even as prices decline. And our direct payer access, especially in Europe and increasingly in the U.S. positions us well in more centralized and value-driven purchasing models.

Barriers to entry in biosimilars remain high. Even after Phase III streamlining, total development time will still be around 6 to 8 years compared to 7 to 9 years before, which is fundamentally different from generics where development takes only 1 to 2 years. This level of complexity and long-term commitment creates a natural entry barrier, and we have all the capabilities needed to win in this environment.

To summarize, we operate in one of the most attractive categories of the pharmaceutical industry, and we have built a business with the right fundamentals to win. The biosimilar market is growing strongly, and we are perfectly positioned with a balanced portfolio, a growing pipeline and a globally diversified commercial footprint.

Over the last 6 years, we have established a true end-to-end powerhouse with proven capabilities in R&D, cost-leading manufacturing and commercial execution across all major regions. These capabilities give us the strong conviction that we will double our portfolio, double our sales and reach around 20% EBIT margin by 2030. Our clear strategy, rigorous execution and strong momentum across our in-market and upcoming launches gives us significant upsides beyond 2030.

And with that, I'm pleased to hand over to my colleagues, who will take you through the levers why Fresenius has the right to win.

Good afternoon. I'm Michael Hammer, leading portfolio and business strategy for Biopharma. I'm joined by my colleague, Fabrice Romanet, our Head of R&D.

In this section, we'll demonstrate how Fresenius Kabi is rejuvenating its biosimilar portfolio to drive long-term profitable growth. Our goal is to show you how our capabilities, track record and strategic priorities are building confidence in our long-term portfolio execution.

Our portfolio rejuvenation is designed to deliver sustainable long-term growth. We've built a highly competitive portfolio and pipeline covering approximately EUR 200 billion in originator sales. Our proven R&D engines leverage complementary in-house hubs alongside selective in-licensing, which gives us the confidence to achieve our goal of delivering more than two new clinical development projects per year.

Over the past 3 years, we have already demonstrated our portfolio speed and differentiation, outpacing many peers in the number of U.S. FDA approvals. Unlike key peers whose portfolios rely heavily on in-licensing, Fresenius Kabi's pipeline is predominantly in-house developed, which in turn supports margin accretion and maintain strategic control.

Let's first examine the biosimilar market. This is set for significant expansion, expected to grow six-fold by 2035. Nearly 300 molecules will face loss of exclusivity over the next decade, representing a major growth driver. More than 60% of these loss of exclusivity sales come from oncology and immunology, areas where Fresenius Kabi has deep therapeutic experience and know-how. Our expertise in these areas position us strongly for upcoming launches, while we selectively expand into other attractive or adjacent segments to maximize long-term profitable growth.

Building on this opportunity landscape, let's look at how we select and execute our portfolio strategy. Firstly, we start with over 1,000 biologic opportunities, narrowing the universe to between 15 to 30 pipeline candidates that can be prosecuted based on several important dimensions.

For example, cost, target product profile, originator global sales and competitive density. A cross-functional team uses a proprietary approach to identify the right opportunities to progress further as we actively develop our portfolio for the future. Each year, our goal is to advance more than two projects into development, ensuring a steady flow of innovation with our immediate focus on monoclonal antibodies.

Our current disciplined approach leverages synergies between immunology and oncology and enables portfolio expansion through both in-house development and strategic collaborations. However, as part of our active portfolio management and as new technologies emerge, we will continue to keep under evaluation other modalities, for example, biobetters, bispecifics or antidrug conjugates.

Let's compare our portfolio size and composition versus peers. Our portfolio includes nine marketed medicines and nine molecules in development, doubling our launch products in the coming years. Peers report similar numbers, but not all potential new medicines are disclosed in early-stage pipelines and many are in-licensed. Fresenius Kabi's strength is substantial in-house development with strategic oversight across the value chain.

Now let's zoom in on our marketed portfolio and pipeline in more detail. We now include six further early-stage candidates, bringing our total to 24. This coverage of EUR 200 billion in originator sales spans immunology, hematology, oncology and respiratory to include marketed products, registrational, clinical and pre-clinical candidates.

Our complementary Fresenius and mAbxience portfolios offer a broad and balanced pipeline, expanding to meet evolving market prescriber and patient needs.

With this strong foundation, I'll now hand over to my colleague, Fabrice Romanet, our Head of R&D, who will take you through our exciting R&D engines and technical capabilities.

Thank you, Michael. It's a real pleasure to be here. Our two R&D engines, Fresenius and mAbxience complement each other, increasing portfolio breadth and competitive strength. Fresenius has a track record in developing high-quality biosimilars for highly regulated global markets, focusing on immunology, while mAbxience brings oncology specialization, large-scale production and expertise in navigating diverse regional regulations.

Together, we cover the entire value chain from lab scale to clinical development until manufacturing and registration with global regulators, integrating feedback from our commercial organization to ensure our target product profiles to meet evolving market prescribers and patient needs. These unique characteristics serve as a catalyst for potential strategic in-licensing, providing access to late-stage clinical medicines with proven data, thereby accelerating development.

In addition, our IP expertise also enables timely and defensible launches. Let's see how these engines translate into successful commercial launches. With over 15 years of biosimilar development expertise, we have launched 9 medicines and have 15 more in the pipeline. Our early-stage hubs in Eysins, Switzerland; and Leon, Spain, excel in small-scale state-of-the-art R&D, while scale-up hubs in Garin, Monro and Leon drive process validation and large-scale production.

After pre-clinical chemistry manufacturing and control stage, our internal capabilities allows us to design robust clinical trials that meet the latest and highest global regulatory standards. We leverage our in-house pharmacokinetic and biostatistics seasoned expertise.

Our track record is clear. 8 U.S. FDA BLA approvals between 2022 and 2025, one of the highest amongst peers. We are recognized as a leading voice in shaping regulatory guidelines to support innovation and patient access.

Next, I will highlight how our technical development enables differentiated and fast-to-market launches. Biosimilarity demonstration is first and foremost about CMC analytical similarity. It all starts in the lab, striving for the best cell clone producer with the highest quality combined with the strongest productivity. Our technical development capabilities spanning cell line development, state-of-the-art technologies and digital system enable us to select optimal cell clones and establish efficient CMC blueprints.

Integrated CMC and intellectual property experts ensure high-quality manufacturing and formulation, while our platform approach for device importantly reduces cost and enhances patient usability. The impact is substantial, faster cycles, right first-time quality and launch readiness differentiation.

Let me share a couple of examples of success. Our denosumab biosimilars, Conexxence and Bomyntra exemplify our ability to turn R&D innovation into competitive advantage.

Our first wave launch secured early market entry with differentiation through a latex-free and unique pre-filled syringe in oncology. This approach prevents allergic reactions and positions Fresenius Kabi as a solo bidder in key commercial tenders, demonstrating our leadership in product innovation and commercialization.

Speed is equally important as shown in our next example. Our first-to-market launch of Tyenne, our tocilizumab biosimilar, highlights R&D speed and agility. Parallel clinical trials for subcutaneous and intravenous formulations means we serve a broad market, including hospital and outpatient settings. We move fast and smart, ensuring our biosimilars are designed in constant dialogue with global regulators and health authorities to meet high development and regulatory standards.

We accelerate the delivery of our trials, our study reports and all important steps prior to the final delivery of the regulatory dossier. This achievement underscores our ability to deliver biosimilar rapidly and effectively with early to market entry.

In addition to our leading in-house R&D capabilities, we strategically identify opportunities to in-license potential new medicines to complement our internal pipeline. A recent example in our partnership with Polpharma Therapeutics is the in-licensing of their vedolizumab biosimilar to further strengthen our presence in immunology, while harnessing existing relationship with key prescribers. We have a proven track record in biosimilar development with a demonstrated ability to achieve regulatory approvals, while adopting IP strategy to deliver launch excellence. These skills combined with a collaborative, agile, fully vertically integrated business unit makes us the partner of choice for Biopharma collaboration.

Let's now look at the evolving regulatory paradigm. Regulatory expertise is essential for continuous and reproducible success. Fresenius has been a leading company in the evolution of the regulatory guidelines, collaborating with global regulators and health authorities to deliver successful policy changes.

For example, the recent waiver of clinical efficacy studies across Europe, U.S. and Canada. We anticipated this evolution and prepared for the increasing focus on CMC analytics and Phase I pharmacokinetic studies. We are increasing our speed of cell line and process development by 40%, leveraging our 15 years of CMC experience with thousands of lab-scale batches and associated data.

Our expertise in biostatistics, data management and clinical operation has delivered more than 10 robust Phase I studies. Our active dialogue with global regulators and health authorities continues as we seek to further harmonize approval frameworks, while maintaining our competitive edge with AI-powered regulatory databases.

In summary, Fresenius rejuvenated portfolio and pipelines covered EUR 200 billion in originator sales. Our proven R&D engines, complementary in-house hubs and strategic in-licensing are significantly contributing to our success. We consistently deliver speed and differentiation as seen most recently in our Tyenne, Conexxence and Bomyntra launches.

Our governance, milestone-driven KPI and culture of performance and accountability underpin our confidence in delivering our ambitions of achieving long-term profitable growth.

Let me hand over to Yannick Sorlet, SVP, Technical Operations, Supply Chain and Project at Fresenius Kabi; and Jurgen Van Broeck, CEO of mAbxience.

Many thanks, Fabrice. Hello, I'm Yannick Sorlet, and together with my colleague, Jurgen Van Broeck, we will guide you through the ambitious cost leadership program we are driving at Fresenius to create significant value for the Biopharma business unit.

At Fresenius Biopharma, we believe in the power of a vertically integrated manufacturing platform, which is the primary strategic driver of significant cost reduction for our biosimilars. Our operating model is based on in-sourcing of all the manufacturing steps from drug substance to fill and finish operations.

We have already achieved significant cost reduction in production for recently launched biosimilars through in-sourcing to our manufacturing sites, including our primary drug substance manufacturing platform, mAbxience.

In parallel to in-sourcing of additional products or manufacturing steps, we are driving additional COGS reduction through other initiatives in the next couple of years along the manufacturing and supply value chain.

On top, we continue to invest into building additional state-of-the-art manufacturing capacity to support our longer-term profitable growth and sustain cost leadership position for the future.

Our current manufacturing footprint and technology is industry-leading, enabling us to cover a broad variety of biologic products and all manufacturing steps. mAbxience operates as our internal platform for drug substance manufacturing with three sites, two with mammalian cell culture and one with microbiological fermentation, with several independent production lines each, while our biosimilar fill and finish site is located in Austria.

We plan to invest more than EUR 300 million by 2030 in new production lines in our existing DS and fill and finish manufacturing sites with the aim to double existing capacity in some technology and steps and in-source more products and volumes in the future.

Together with increasing the capacity and enhancing the technology, we are also maximizing the potential of economy of scale to enable another major reduction in cost of production within next 5 years.

Further reduce COGS, we have developed an ambition program with diverse and complementary initiatives. Along with our main strategic pillar of vertical integration, we are optimizing our manufacturing technology and scale, the productivity of our production processes and the efficiency and effectiveness of our supply chain to outperform competition in terms of speed, reliability and agility.

We have clarity on how to get the best-in-class COGS and are confident that we are doing the right thing to deliver significant savings through these initiatives. While we have demonstrated our capability of managing a complex network of both internal and external sites, we will continue our journey to internalize all manufacturing steps from API to finished product manufacturing.

Since this year, we have established a fully integrated manufacturing and supply chain for tocilizumab, which will deliver several million euros savings per year versus supply from Merck. Our capacity coverage target is to progress towards 80% internal and 20% external manufacturing in longer terms.

I will now hand over to Jurgen Van Broeck, who is going to tell us more about all the ongoing mAbxience biosimilar manufacturing cost reduction initiatives.

Thank you, Yannick. As CEO of mAbxience, I will now elaborate on how we are increasingly taking a key role and as the manufacturing platform for Fresenius Biopharma, while driving cost leadership.

How? Well, first, the internal manufacturing gives significant more supply reliability and less supply complexity. Constant structured efforts to increase process productivity and efficiency impacts cost of goods of the tech transfer products in the short term. The increase of scale which will be realized in the planned capacity expansion generates a midterm COGS improvement and production flexibility.

Lastly, several initiatives are analyzed to further drive supply agility whilst being cost effective. We are not waiting for increased scale to optimize the cost of goods of the products. Continuous productivity efforts through improving yield, raw material costs and cell productivity are already delivering for key products. For example, for bevacizumab, we have already significant improvements, and this is already in the market.

In terms of increasing supply agility, we mentioned already that this is key in a dynamic biosimilar market, a 1/3 lead time reduction through further implementation of lean manufacturing principles and production and on the other hand, through optimization of the supply chain itself. This needs to be realized in the coming years.

Our integrated manufacturing platform needs to be at the forefront of innovation and manufacturing potential. We are building a future-ready platform to deliver long-term profitable growth. Therefore, a mid- to long-term plan was created to understand the capital investment required to achieve our ambition. We will continue to invest in automation and digitalization, including AI, while assessing the return on investment from potential geographic footprint expansion and the adoption of new advanced manufacturing technology. These initiatives are already in the planning.

To conclude, we are operating a cost-leading manufacturing platform across the full value chain, including drug substance, drug product and finished product, along with global certification. This expertise supports our goal to becoming a global leader in biosimilars. We have already achieved significant COGS reduction through the benefit of full vertical integration from drug substance to finished product manufacturing.

We'll continue targeting additional COGS reduction through product and process optimization initiatives on capacity, productivity and supply chain efficiency. With our end-to-end manufacturing network now established, we are investing more than EUR 300 million over the next 5 years to further expand capacity and drive long-term profitable growth.

I will now hand over to Sang-Jin Pak and Molly Benson, our SVP, Commercial for U.S. to talk about our third value creation pillar, commercial excellence.

Thank you. You have just heard how our portfolio, our R&D engine and our manufacturing sale come together. The next natural question is, how do we translate all of this into commercial impact? And that's exactly what our balanced commercial footprint across geographies delivers and what Molly and I will detail in this part.

We achieved commercial excellence by executing successfully across key regions by using a targeted go-to-market strategy molecule-by-molecule and by derisking our revenue streams through our commercial network and selected partners with milestone payments.

Another way to look at the expected doubling of our revenues is through the lens of our commercial model mix, which shows how we want to balance between direct sales and out-licensing over time. Historically, a significant portion of our Biopharma revenues came through out-licensing partnerships, reflecting the way we scale mAbxience while building our own commercial network.

As this network expands, a growing share of our revenues will come from our own sales engine across different markets and channels. This shift will increase margins whilst reducing our dependency on milestone payments.

Looking ahead, direct Fresenius sales are expected to account for the clear majority of our EUR 1.6 billion in expected revenues for 2030. This reflects the impact of the commercial excellence we are now embedding across regions. Out-licensing will remain part of our model, use selectively in markets where partners can accelerate access, extend reach or complement our capabilities. But the overall direction is clear, a deliberate shift towards a higher share of direct sales as we scale our own global commercial presence.

Our commercial model is balanced and diversified across Europe, Latin America and the U.S. In Europe, we have a deeply established direct sales presence in more than 20 markets, coupled with strong payer access and tender excellence. This allows us to consistently secure leading positions at launch.

In Latin America, we are the leader in Brazil and Argentina, supported by strong regulatory environments and local manufacturing. These markets also act as incubators for early launches, enabling us to build real-world evidence and execution muscle ahead of global rollouts.

In the U.S., we are scaling rapidly with high double-digit revenue growth year-over-year 2024 to 2025. We are applying innovative approaches in contracting and distribution, and we are deliberately expanding our footprint in a market that will represent more than half of global biosimilar industry by the mid-2030s. This global balance significantly derisks our revenue and enhances our growth resilience.

Europe is where our integrated commercial model is already fully operational and at scale. We have a direct presence in more than 20 European markets, covering both public and private provider systems. This gives us deep access to procurement structures and clinical stakeholders.

Our regional key account teams engage directly with decision-makers, supported by long-standing relationships across a broad network of partnered hospitals. In total, we have partnered with over 25 leading hospitals and hospital purchasing groups for tocilizumab.

We also benefit from a clear competitive edge in tenders. Our pan-European tender framework harmonizes processes and systems across countries, allowing us to compete with speed and consistency. We have defined tender playbooks, including best practices and training. Combined with our expertise in multi-country and multichannel bidding, this creates a strong platform for upcoming tenders. And this year alone, we won 40 tenders in Europe.

Performance management is another differentiator. Our analytics solution brings together external sales data and internal customer-facing metrics to help us allocate resources precisely, refine our messaging and focus actions where they have the greatest impact. This disciplined approach is already reflected in our commercial results, most notably a 32% market share in tocilizumab biosimilars with Tyenne.

Overall, our results in Europe demonstrate the effectiveness of our scalable integrated commercial model and how it can be replicated as we expand our direct presence in other geographies.

We have achieved a level of commercial excellence in two of the most important LatAm markets: Brazil and Argentina. And have demonstrated capabilities that we will leverage in other markets.

First, Brazil and Argentina serve as incubator markets. The IP and legal environments allow for early, low-risk launches, giving us the opportunity to gain commercial experience ahead of global rollouts. Both markets also benefit from strong fundamentals. We are among the largest Biopharma markets in LatAm and the public health system covers the majority of the population in Brazil.

We have engaged in Brazil for more than 40 years and thus built a robust value chain and trust. The Brazil public market allows for productive development partnerships. This is a 10-year supply agreement, which guarantees us minimum 40% of the public market.

In Argentina, we also hold a strong market position. This is supported by our ability to leverage the local manufacturing sites that Yannick presented earlier. In addition, our experience operating within Argentina's dual national provincial tender structure has been a major driver of our tender excellence capabilities.

Managing tenders across two parallel systems, national and provincial has required a high level of coordination, which we're now applying across other tender-driven markets. Brazil and Argentina will continue to serve as key capability hubs as we expand our direct commercial model and accelerate launches in additional markets in LatAm and worldwide.

So, I will now turn over to Molly to lead us through the U.S.

Thank you, Sang-Jin. Hello, everyone. My name is Molly Benson, and I am the Senior Vice President of the U.S. Biopharma organization. The U.S. market for biosimilars continues to be an attractive and growing market. If you take a look at the number of molecules that will be losing exclusivity in the next 5 and 10 years, it is significant. Not only does the loss of exclusivity make it an attractive opportunity for growth, but also due to the complexity of the reimbursement and a strong interest for the need for change by plans, providers and patients. In addition, there is an increased attention to policy for cost savings and the need to support biosimilars in the U.S.

These three factors, the number of loss of exclusivity in molecules, the need for change to reduce complexity and reimbursement and the increased attention to policy are aligned to our commitment to biosimilars as an organization.

Looking at our showcased Tyenne. Tyenne is the first and leading biosimilar in this class and is available both in IV and subcu. Our market share has grown to 14% through September. And when you include our partner agreements, the market share is now over 18%. This is a proof point of how we gain momentum while launching first to market in a very short time period.

The reason Tyenne is a highlight is because it is the fastest-growing pharmacy benefit biosimilar in the immunology space in the U.S. At the same time, the launch of Tyenne also expanded the market 15% year-over-year, which demonstrates the unmet need for access to the tocilizumab therapy. Our access coverage also continues to expand in 2026 from parity to exclusive coverage.

The U.S. Biopharma organization is committed to biosimilars being a long-term sustainable solution for affordable and accessible medicines in the U.S. We have the opportunity to bring our portfolio strength with a molecule-by-molecule strategic approach to adapt to the business needs of the market.

There are three pillars of our go-to-market approach. First, individual contracting. We have the ability to learn from our launches and adapt to our customer needs. This includes provider and payer initiatives with innovative agreements to increase share. An example would be with our adalimumab-aacf molecule that grew 74% year-over-year with the success of alternative agreements.

Second, access execution. As mentioned, we have the opportunity to bring a customized strategy to the market. It gives us the ability to optimize our life cycle management for a long-term and sustainable approach in the market and grows our opportunity to develop partnerships. An example with Tyenne and our increased formulary coverage with payers now covering over 70% of the U.S. market.

And third, evolving our capabilities. As the market evolves, so must we. We have evolved our internal skill sets to adapt to the market with a hybrid approach. This gives us the ability to flex with our field and marketing pull-through initiatives based on molecule market and life cycle, an example of how we activate our internal teams to support payers and providers with education and resources to optimize pull-through.

We have demonstrated the ability to bring value and volume to the market quickly with our alternative and innovative agreements. For example, with Evio, which is a pharmacy solutions entity that was created by six owner plans, we have agreements expanding our biosimilar coverage to over 20 million members across multiple regional players.

Also, Cost Plus is another organization that is committed to affordable and accessible medicines in which we now have multiple products added to their formulary to bring value and volume.

And with CivicaScript, which is a fully transparent distributor created by Blue Shield organizations across the nation covering over 100 million lives, we have announced an exclusive distribution agreement on our unbranded ustekinumab. These are just a few examples of how we have evolved and adapted to the market and customer needs.

In summary, it is an exciting time for the U.S. biosimilars market, and we have a long-term commitment to the success of biosimilars. The U.S. market is an attractive and growing market, which aligns with our path forward. We will continue to expand our portfolio strength with a molecule approach to evolve the business, and we have demonstrated the ability to adapt, innovate and grow based on the market and customer needs.

With that, I will hand it back over to Sang-Jin. Thank you.

Thank you, Molly. Let me summarize how we achieve commercial excellence. We execute successfully across key regions with deep payer access in EU and leadership in Latin America, while gaining traction in the U.S. and scaling access in other regions. We have a targeted go-to-market strategy molecule-by-molecule, which has proven successful, for example, with the first-to-market launch of our leading tocilizumab biosimilar. And we will continue to de-risk our revenue streams through our commercial network and selected partners with milestone payments.

What you have seen today is a Biopharma powerhouse with a clear value creation strategy, a differentiated portfolio and R&D engine, a vertically integrated manufacturing footprint and a commercial model that wins across regions. The market opportunity ahead of us is significant, and we are ready to capture it. The path forward is defined. The levers are in place, and we are well positioned to deliver on our ambition of doubling Biopharma revenue by 2030 with around 20% EBIT margin. We know exactly what we need to do, and we are already doing it.

Thank you for your attention, and we look forward to your questions.

Thanks, Sang-Jin. Great presentation by you and the team. We're going to begin the Q&A session. Firstly, I just want to remind everybody that this event is being recorded. Similarly, questions can also be submitted in writing via the web. For the sell-side analysts that have joined the call, that have dialed in, obviously this is a simultaneous conference call. So, you can also ask your questions live via the audio line.

[Operator Instructions] So, we're going to take our first question actually from the webcast. And this question, in effect, is asking, why does it make sense for Fresenius to be in biosimilars? What is the overall strategic rationale? And how different will the business look in 3 years from now, considering the loss of exclusivity in peak year sales in the next several years compared to 2030?

So maybe Michael will come to you in the first instance, please.

Yes. Thanks, Nick, and welcome, everybody, again. And also thanks for the first question after what I would call a really deep and interesting presentation, which will give you a lot to chew on and also for Q&As, not only today but going forward.

Look, from what we've been seeing, I could make it very short by saying, because we are the best owner of such an asset in a highly, highly attractive and vibrant market. Obviously, it is also fitting with our vision and mission that we want to deepen of providing highest quality and cost-efficient products to patients around the world and help healthcare systems to be much more efficient and get to much better outcomes.

But what we've been seeing here today in the presentation, how vibrant it is. And if you look at what has changed in the last 2 years, it is an evolving structurally attractive market when you only look at the loss of exclusivity and the need worldwide for, for example, oncology and immunology drugs.

By the same token, having a vibrant, attractive structural market we are very well positioned. This was what it was all about, that we have the capabilities through the entire value chain, what Sang-Jin called as building a bio powerhouse. And that is the strategy that also in terms of resources, we're going to double down. And for the overall company, it is even great because next to our biosimilars business, we also have other growth vectors.

So the future looks quite bright, I would say, if you are well positioned in this attractive market and how will it look like in the next couple of years. I think this is exactly what we alluded to. The direction of travel is clear, the momentum only going upwards.

Thank you, Michael. We're actually going to take our next question from Veronika at Citi. So Veronika, over to you.

Excellent. I hope you guys can hear me okay.

Absolutely.

I have a couple of sort of financial questions. Apologies for bringing it back to the EPS number at the end of the day. But just want to understand, I guess, the degree of conservatism, if that's the right term in the guidance that you've given when it comes to revenues. Obviously, you've exceeded your targets. I don't know, Michael and Pierluigi, if you can talk about the process through which you've kind of built this assumption of doubling the revenues.

And I guess as you think about it, to what extent do you think the risks are balanced to the upside versus the downside, if you can maybe talk through that process, just to give us some degree of confidence around that number.

And then my second question is just on the margin target. Obviously, my understanding is you're already looking at profitability that's in the low to mid-teens from a margin perspective. Obviously, 20% is terrific. But I think the slide said 20% by 2030. So I'm curious as to what the shape of that margin curve looks like. Do we -- could we get there a lot sooner than 2030? What are the pulls and pushes? And that will be it for me.

Michael, do you want to take the first question?

Yes. Veronika, look, we've been expecting exactly that question and maybe even with the undercurrent, which you've been given. Look, this is, for us, more important to give you the direction of travel, the direction and, let's say, the trajectory of the development of the business. And I think this is net-net-net, all positive. Now this industry is still in the making. A lot of things happening, Sang-Jin was talking about, Molly was talking about, for example, on the only regulatory front in the U.S., for example, a lot of changes only in the recent past.

Also, what you need to do when it comes to the whole development piece. So, a lot of things still need to happen in the industry as such when it comes to payers, when it comes to regulators, when it comes to the adoption of, for example, new and innovative commercial vehicles. So, in such an industry to even make a statement, I would say that is pretty bold and very self-confident. That is not a mature industry, which we have been witnessing for the last 20, 30 years.

So, I think what we've been laying out is with the things we have in our own hands, which is be great in development, be very cost competitive on manufacturing and then be very close to the customer and then manage the complexity overall, but also other things which are happening outside of the market, that is the direction of travel, and that is the puts and takes.

So, it's not wise and prudent to take a ruler and do a normal earnings conversion kind of thing in an industry like that. But I would say it is very bold, because it's net-net-net, very, very positive. And if the adoption and everything works out fine, then there is obviously opportunity for more. It was more important to say this is the clear direction, not hitting a landing point in '31. If this is more, it's going to be more, and we will update you along the way.

Thanks, Michael. I think it's fair to say those comments would probably also apply to Veronika's second question on margin. So, rather than repeat ourselves, I suggest we lean on those. Can we come to the next question from Oliver at ODDO. So Oliver, over to you, please.

So first, for clarification. So you talked about doubling the portfolio. Is it based on the -- sorry, doubling revenues? Is it based on the existing portfolio? Or does this doubling also include the new product?

And second, about the manufacturing process. So, on one slide, you shared that mAbxience operates at around 75% of the industry cost base. So it would be great to have a little more flesh to the bone. So, how it is calculated? Is it just due to your own manufacturing? Or are there other cost advantages?

Okay. Yes. Thanks, Oliver. Well, exactly, Michael. We'll come to Sang-Jin on the manufacturing, please.

Yes. So I think for the first question on, is this coming from our currently marketed molecules or are there any new molecules involved as well in the doubling until 2030? So in that timeframe and in that forecast, we have nine marketed molecules. The main drivers are tocilizumab, but also adalimumab, denosumab, ustekinumab, pegfilgrastim, and so on. And there are nine late-stage launches that are also contributing to the sales. And namely, I can mention aflibercept in ophthalmology, but also vedolizumab, which also launches at the end of the decade and will contribute to this.

Thanks, Sang-Jin. Shall we take our next question, which is -- let me do sort of a couple from the webcast. So, Falko Friedrichs at Deutsche Bank, you did ask a question with regards to phasing of the revenue margin development. I guess we've already sort of touched on that based on Veronika's question.

So the next part of your question was around how competitive is the market environment for in-licensing deals. And then the other part of your question is really, sort of, clearly, there's a lot of companies that are out there looking at these transactions. So, I guess it's our confidence and ability to fundamentally be the partner of choice in terms of ensuring that we gain access to these attractive deals and what does it take to win.

So maybe, Sang-Jin will come to you from an on-the-ground perspective.

Yes. Maybe first comment I want to make is that we have a balanced mix that enables us to secure first wave potential and sale and launches. And so, we don't rely only on in-licensing opportunities, but also we have an in-house development machine with two R&D engines that enable us to launch first to market. The in-licensing opportunities, we take very seriously. And yes, the competition is high. But just recently, we have actually managed to in-license two molecules, which are very promising.

I mentioned already aflibercept, and the second one, vedolizumab from Polpharma. And so we are very confident that with our commercial footprint and our proven track record that we are a very attractive partner for potential in-licensing partnerships.

Maybe let me add on that one because, Falko, your first question was the same like Veronika, and there will be a couple of these as we have expected after the first kind of comments.

What you hear already Sang-Jin saying is, when I say travel of direction, it is clear that we have been laying out with everything we know today. That means that is pretty much when you come to risk and opportunities, de-risked from the molecules we know and have today. And everything which is then in outer years, obviously has a bigger uncertainty. That's why I said it is a very bold statement. I don't like the word conservative, but you can label it as you want. A bold statement de-risked with everything we have today.

The second thing what Sang-Jin just said is, it is about that we will go molecule-by-molecule. We are very well positioned for the in-licensing, gave you the logic of how we do it, but we do not need to do every deal. It needs to be very attractive for us. And then we're going to put in one molecule after other in the pipeline.

Thanks, Michael. Can we take our next question from David Adlington, please, at JPMorgan. David, over to you.

Given the recent update on the U.S. regulatory environment in terms of reducing costs and times to market, I just wondered how that influenced your thinking about the competitive market, both in terms of numbers of competitors and also pricing over the medium term.

Thanks, David. Sang-Jin -- David, sorry, do you have a second follow-on?

No, that's -- the other one has been asked.

All right. Perfect.

Yes. So in terms of the recent policy changes that we've seen, especially on the clinical Phase III trial waiver, but also the simplification of interchangeability. That, of course, has two impacts.

Number one, it can reduce the timing of the development time lines. And currently, it was somewhere between 7 to 9 years, and probably we can shape it off by 1 or 2 years.

Second, it will also reduce the cost of the clinical development, because the Phase III trials are now not needed anymore. And that, of course, could invite smaller players, more players to enter the market. But we believe that there are still high entry barriers to this market, because you still have the 6 to 8 years of development timeline. So the returns on your investment will only come after a long period of time.

You have high CapEx investments. You need to have analytical requirements. You need to have expertise in regulatory authorities and what the demands are from their side. And so you need a lot of expertise and capabilities, and a lot of investment cost. And so, not everybody is able to successfully navigate through this.

And so we believe with our now mAbxience end-to-end vertically integrated manufacturing setup, we are now able to cover the full value chain from development to manufacturing all the way to global commercialization. So, we are very well positioned in order to thrive in this new environment, whereas probably smaller players who only cover maybe one part of the value chain will be disadvantaged.

I want to just have a quick comment on what Sang-Jin just said. One element which really distinguishes ourselves versus the competitors is also the fact that we have a very strong global coverage from a commercial standpoint. Thanks to the other three business units. And this, I believe, it is really a distinctive strength, because we can also leverage the infrastructure -- commercial infrastructure that we have across the globe, including the U.S. and therefore, the strong recognition and perception that we have as a reliable player across the globe.

Thank you, Pierluigi. Okay. I'm just going to pick up a couple of comments on the webcast. So maybe, Sang-Jin, if I can come to you, just maybe a comment around how we think about the evolution of biosimilar pricing. What are we seeing potentially from sort of an erosion in competition perspective? I guess, really, how does this compare to what we've seen previously? And then, if I can also fold into that a little bit, I guess, linking back to sort of some of the comments around the pipeline and obviously, the role of business development. Can you also just comment on the early-stage pipeline, which has obviously got the focus around immunology and oncology, but where might we look to go potentially in the future?

Right. So, I think we can see significant price erosions and also increased competition, but we cannot say definitely that it has translated into uniform price pressure across the whole portfolio. So, there are still molecule-by-molecule, very profitable niches and pockets of differentiation.

I want to give you two examples. Number one, of course, our bestseller tocilizumab, which is in a market with probably about 2 or 3 other competitors. So it is fairly niche, and we are first to market. So we were able to do a lot of contracts in those key geographies.

The second one is around differentiation. And our denosumab biosimilar, especially for oncology called Bomyntra has a differentiating factor that no other biosimilar has. We're the only ones with a pre-filled syringe of the 120 milligrams. And therefore, we're unique. And we've now seen already the first success in the U.K. where we won the national tender with this.

So in terms of pricing, yes, it is competitive. But unlike small molecule generics, because that's always the next question that's coming, is it going exactly the same direction and already mentioned? No, the CapEx investments are different. The development lead times are much longer and the entry barriers are much higher. So there will be in the future, more and more specialized players such as us, probably with a fully vertically integrated manufacturing network that will be successful in the future.

A quick comment on pipeline in the future. I guess it's fair to say you're going to be agnostic, but maybe you want to correct this.

Yes. I mean, it's true that we started to focus on immunology and oncology, but we are a therapeutic area agnostic and we are very opportunistic with where we place our bets. What's more important for us is the potential to be first-to-market, then that we have the most competitive cost of production and that within our vertically integrated network and that it fits well with our regional geography go-to-market strategies. And so in the future, we will be in ophthalmology, but also in hematology and respiratory. Just to name a few.

Super. Thanks, Sang-jin. I'm just going to pick up one question, which is, again, sort of with regards to the timing of loss of exclusivity relative to sort of the '26, '27 period related to the doubling of revenue.

Look, I think it's fair to say, as we've already said, that this is very much about what we already have in our hands, which gives us the confidence to deliver on our ambition to 2030. So yes, you're right, there is a, shall we say, trough period in terms of loss of exclusivity, but the 2030 ambition is not contingent on that. And as we've already alluded to, there's also business development upside beyond our 2030 ambition.

If I sort of come back to a webcast question, which is a little bit more broad, which is looking at capital allocation, maybe, Michael, I can ask you in terms of how do we balance investment at the group level. And then maybe Pierluigi, sort of, a comment around how you think of capital allocation at a Kabi level. And then there I say it, Sang-jin, maybe just how you think of it from a biosimilars in terms of R&D capacity and how you prioritize those investments at a business unit level to ensure future long-term success. So maybe, Michael, group perspective first, please.

Yes. Thanks, and I'm grateful for the question because that gives us the opportunity to show what our operating model is. Although we have these different layers, it is not 3x capital allocation decisions with a full degree of freedom. It is more or less when we started the journey on future Fresenius that we said capital allocation as to where the money will flow on the group is the primary task of the Management Board.

If you look at our financial framework, Fresenius financial framework, there is the growth on revenue and the margin bands for the businesses. Within that, obviously, they can allocate what I would rather call resources on a business unit level and Kabi manages the operations between the businesses, and Pierluigi can allude to that one. But where the capital goes is clearly the task of the Management Board.

And now we have determined the core with the six businesses we have, all businesses, all six businesses, and we went into one of them quite deeply today, are in very attractive positions and have runway for growth.

The second thing, what the group did achieve over the course of the last 3 years, we have the degree of freedom that we delevered without, for example, selling FMC stake. Now when it comes to capital allocation, as is what Sang-Jin and the team were alluding to the EUR 300 million capacity expansion, that is obviously baked into their plans and now he can decide between R&D and manufacturing and Pierluigi will manage them together with all the three other businesses that we get the highest yield on the assets which are deployed.

But the key thing is, it will be key to double down in resources. That's why in Rejuvenate, we said scale platforms. We need to scale with capital contribution. Capital contribution can be R&D, capital contribution can be CapEx, Capital contribution can be in-licensing and can be even more. The good thing is we have the balance sheet today, and we will remain committed to what the financial framework said, that is the 2.5x to 3x on the net debt-to-EBITDA, the ROIC, which is there, where we need incremental improvement. It is hardwired with our long-term incentive. And the biggest driver, obviously, is the operational businesses getting progress, and then we can talk about whether the EUR 2 billion and the 20% is conservative or not, but this is the way it works.

Pierluigi?

I would just iterate what Michael said that we have a pretty robust methodology when it comes to resource allocation within Fresenius Kabi, making sure that we drive allocation to generate sufficient returns, attractive returns for each of the business units based on their potential. And certainly, for Biopharma, which is why we are here today, we are making sure like the EUR 300 million CapEx that we will happen over the next 5 years that we have what it takes in order to continue to drive this business successfully, competitively and make sure that we're going to stay as a long-term successful player beyond 2030.

Anything you want to add, Sang-Jin?

Actually, I think everything was said already and that we have a very rigorous metrics and measurements of how to decide strategically and financially which pipeline products we invest in.

But I want to maybe just add that we have those two complementary R&D engines. And we very rigorously look at first-to-market opportunities. We look at the full target product profile, and we look at competitive cost of production, which means a simplified supply chain. And if these are given, then these can be candidates for in-licensing pipeline.

Just because you mentioned the cost of production, maybe I can come back to you with a question again from the webcast, which is looking at the average development costs, small molecules relative to biosimilars today, anything in terms of estimation in terms of how much this potentially could fall given the recent draft guidance from HHS with regards to potential move for the Phase III and obviously interchangeability relaxation. So, any comment you can make there would be grateful.

So the first comment is, yes, the development costs will decrease by the level of the Phase III clinical study, but it's still different molecule-by-molecule, right? We are seeing, for example, in the oncology space, where you still need to buy -- where you needed to buy the reference product, which is very costly and expensive. There might be a greater cost saving versus, let's say, in immunology in the pharmacy benefit space. But it's molecule-by-molecule, it's different.

And I think the cost savings are one on the one side, but I think the lead times are very important. And with these cost savings, I think now all of a sudden, we are able to target molecules which are smaller in size of the peak year sales of the originator. And therefore, we can now develop biosimilars for indications where previously there was no other alternative. And I think that's a good thing for patients, but also for payers.

But maybe let me reiterate, because we're going to get this question also all over during the roadshows. I think what Sang-Jin mentioned before, it is really important to understand a biosimilars business is not a small molecule business. It's just not. It's a completely different modality. Through the entire value chain, you need totally different capabilities in development, you need capabilities and you need the resources.

Resources means financial resources. We talked about what kind of efforts it already starts with patent litigation and so on and so forth. And then I think Fabrice gave you a nice picture of what it takes during the development process. The manufacturing is a totally different one. This is not process manufacturing like in small molecules. This is bioreactors. This is living organism. This is a different rigor on quality and everything.

And then it comes to the commercialization, which is also different. And by the way, the -- let's say, the deregulation efforts of the administration, which we fully obviously endorse and acknowledge will not lead to any commoditization of biosimilars but rather will push the diffusion and adoption with everything else, which is being -- needs resources and capabilities being intact. And therefore, we are betting on what Sang-Jin and the team calls powerhouse of Biopharma.

I think can I also just throw another comment, which I think is also important, even though the costs are coming down from a development perspective, we've also got to recognize, obviously, there is still going to be the IP litigation costs, which will continue to be a barrier or hurdle to entry.

Conscious of time, before we come to you to wrap, Michael, there was a question I just want to pick up on ROIC, and it's a very simple one, which is we're not going to disclose ROIC at a biosimilar level. But just as a reminder, remember, from a group perspective, we talk about capital efficiency in the range of 6% to 8%. I think it's also important to acknowledge that, that very much reflects some of the legacy challenges for the group. And as a consequence, if you adjust for goodwill, we're much closer to sort of the 12% mark. So I just wanted to address that because that was a question on the webcast.

But maybe, Michael, now that we've concluded the Q&A, if I can come to you for some closing remarks, please.

Yes. First of all, that we did display the ROIC without the goodwill was a suggestion of you guys from the market saying, why don't you display that? Because we -- I think we can all agree value is only created by incremental value creation going forward. The goodwill is the goodwill we have to carry. And therefore, if you only look at even within -- with the goodwill, the increment which the company has been delivering in the last 3 years, and Pierluigi just said, he's going to be hard-nosed on making sure that the EUR 300 million investment in Biopharma will yield its not only planned but really desired outcome. That is the way we manage. So future value comes from incremental value going forward with or without the goodwill.

But now let's wrap it up. I think, first of all, thanks a lot. It's December, I know, for the questions and the interest following not only our journey on the company, but today, this what we call very educational session on biosimilars. What you have seen, and that is true for biosimilars, but the good news, it's equally true for all other five core businesses we have.

The fundamentals we see in today's world when it comes to asset allocation, the stuff is not economically sensitive. This is healthcare. So, the underlying growth drivers are intact and are very much driving the growth, and we want to get our fair share of the procedure growth. And it's also not in an arena where it's a lot of, let's say, wishful thinking of what can happen or not happen with AI. This is real.

We showed you what is real in there, what is our ambition going forward, de-risked with everything we have in the pipeline today. It is an attractive market. It is a vibrant market. Maybe we'll come back in 2 or 3 years and do it again. And I'll bet there will be a lot of change. I will also predict there will be a shakeout of players. We want to double down and create what they call a Biopharma powerhouse by launching and scaling.

We have the R&D machine and told you how capability-driven, resource-driven that really is and that we have the right pipeline, good questions of in-licensing versus own development. You saw what it takes. If it's price sensitive, price competition is there, then you better have your costs under control when it comes to cost of goods sold, you've got a glimpse. We have a manufacturing platform. We have a manufacturing machine. By the way, and this is also what Pierluigi is driving now, a lot of digitization and AI can help to bring down the cost there, in a setting where you still need to be capable of really delivering on that manufacturing platform.

And then the commercial excellence, Pierluigi also highlighted globally, we can even hinge on infrastructure-wise on the other businesses, but then very tailored, very tailored individual geographies, even in the U.S., spreading what Molly said with new innovative kind of access models. And that's why 2x revenue, EBIT margins 20% direction of travel, I still believe it's bold. It's net-net-net positive because it's de-risked by what we have. Obviously, we need to deliver on what we have.

We need to work on it. We need to deliver in the next couple of years. But it stays that vibrant and all fundamentals lead to healthcare system needing to be more efficient. That is a key contributor. Who knows we can even be in a position to deliver more. We are excited, watch this space. Merry Christmas, Happy New Year. Over to you, Nick.

Nothing more to add apart from thank you very much, everyone. As Michael said, enjoy the holidays, and we'll see you all in January.

Good afternoon, and welcome to the conference call of Fresenius Investor Relations, which is now starting. May I hand you over to Nick Stone, Head of Investor Relations.

Thank you, Valentina. Hello, everyone. Welcome to our year-to-date and Q3 earnings call and webcast. The presentation was e-mailed to our distribution list earlier today and is available on fresenius.com.

On Slide 2 of the presentation, you'll find the usual safe harbor statement unless stated otherwise, we will comment on our performance using constant exchange rates or CER.

Today, I'm delighted to be joined by Michael and Sara, who will take you through the EBIT guidance raise and the disciplined execution that drove the continued performance this quarter.

As usual, the call will last approximately 1 hour with a presentation taken around 25 to 30 minutes with the remaining time for your questions. To give everyone a chance to participate, please limit the questions to 1 to 2 only. We can always come back for a second round, if needed.

And with that, I will now hand the call over to Michael.

Yes. Thank you, Nick, and welcome to everyone joining us on a very, very busy day. Exactly 3 years ago, we hit the reset button and then embarked on a new strategic and transformative journey to deliver a step change in performance with what we call future Fresenius.

This transformation was about simplifying our structure, sharpening our focus and instilling a performance-driven mindset. But it wasn't just about operational changes. It was about rebuilding the portfolio, reshaping our culture and fostering accountability, a cultural power driving us forward.

Fast forward to today, and we have started the next phase, Rejuvenate. This has kicked off with great traction and focus and will guide us for the next few years. This phase is all about upgrading the core, scaling our platforms and as a result, elevate our performance to deliver profitable long-term growth.

This means, in essence, bringing new products and innovations to market, focusing on the needs of patients and customers and infusing fresh energy into our leadership and management teams to deliver further value, expand ecosystems and create more opportunities for the company. At the start of the year, we committed to delivering incremental revenue and earnings growth through new products and services, and our performance year-to-date demonstrates our continued momentum.

Future Fresenius continues to deliver. I am pleased to share with you yet another strong quarter driven by the resilience and consistency of disciplined execution across Kabi and Helios. Despite ongoing macroeconomic volatility and geopolitical tensions, we have maintained transparent market communication our adaptive and focused strategy has proven effective in navigating these challenges.

Now let's turn to the third quarter highlights. After an excellent start to the year, I'm pleased to announce that following the Q2 organic revenue guidance upgrade, we're now raising our full year EBIT growth guidance from 3% to 7%, to 4% to 8%. The upgraded guidance represents the success of our future Fresenius strategy and is based on the excellent momentum we have seen year-to-date.

Encouragingly, we see sustained strength in our bottom line with core EPS growing by an impressive 14%, significantly outpacing top-line growth. This performance reflects strong market position and top-line growth yielding margin expansion, and we expect this momentum to continue.

Kabi is an ongoing key driver of our profitability, achieving an excellent 16.7% EBIT margin. We see broad-based performance across all Kabi segments with particular strength from newly launched products and continued pipeline progress, particularly in our IV generics and biosimilars. Great job by the team.

Helios delivered another good quarter, maintaining a solid EBIT margin, demonstrating the resilience of its operations. In addition, based on the strong cash flow delivery in the quarter, we are now back in our self-imposed target corridor that we have tightened at the beginning of the year.

Now let's take a closer look at our core businesses, starting with Kabi. In pharma, we have further focused and simplified the business with the successful divestment of the Calea Home Care business in Canada. In the U.S., I am pleased Fresenius was recognized for supply and service excellence. These recognitions demonstrate our unwavering commitment to ensuring supply continuity for essential medicines and technology.

It also recognizes the more than $1 billion we have invested over the several years to strengthen our capabilities and support for the U.S. health care system. We will continue with U.S. investment to support the health care system to deliver affordable and life-changing medicines for patients.

In Nutrition, we continue to enhance our globally leading portfolio and strengthening our position in this fundamentally attractive market through innovation and differentiation. In Q3, we delivered 3 new product launches focused on patients with high energy and protein needs in MedTech, we announced our leadership of the EASYGEN consortium a collaboration with industry and academia aimed at accelerating CAR-T cell therapy manufacturing reducing costs and improving patient at across Europe. This initiative underscores our commitment to advancing cutting-edge therapies and technologies.

Now turning to biopharma. Again, we are increasing sales quarter-over-quarter as more medicines launch into key markets. For denosumab the key milestone was achieved with a CMS issuing permanent and product-specific billing codes, the HCPCS Q-codes. This is an important step forward in expanding access to high-quality biologic medicines, while driving broader adoption and ensuring more patients benefit from these innovative cost-effective treatments.

Another major milestone was the first delivery of Tyenne vials to European countries from our Map Science plant in Argentina. We have now largely completed the technology transfer delivering a fully vertically integrated supply chain and manufacturing platform to support Cayenne. This marks a step-up upgrading our core to deliver efficiency and increased capability showcasing the benefits of a vertically integrated platform.

All these advancements underscore our commitment to patients around the globe to deliver accessible, innovative and high-quality health care solutions. Kabi remains at the forefront of innovation, operational excellence and patient care.

Now let's take a closer look at our resilient and a very strong foundation. Our highly cash-generative pharma business continued to deliver strong and stable performance. Year-to-date, we have successfully launched 12 products with a total of 15 launches expected for the full year.

As part of Rejuvenate, we are further optimizing our cost of goods sold, streamlining our network and strategically investing to further scale this high-margin platform. With a globally leading portfolio and a local for local approach, we deliver essential medicines to patients worldwide. In the U.S., we supply 70% of the FDA's essential medicines list underscoring our critical role in health care in the U.S. with stable organic growth, highly accretive margins and an attractive cash generation, pharma remains a strong contributor to our balance sheet and a profitable foundation for sustainable long-term growth.

Now double-clicking on biosimilars, we continue to see strong growth momentum, really strong growth momentum. Last year, the business reached EBIT breakeven, marking its transition into a scalable, fully operational platform. With Map Science, we have built a robust development and manufacturing platform, demonstrating our ability to quickly advance molecules from development through regulatory approval and into the market.

Our biopharma franchise has now 11 products launched and marketed globally. As previously outlined, a key advancement of biopharma is the integration of Map Science to deliver a dedicated development and manufacturing platform, including contract manufacturing. For biopharma, we will continue to upgrade the core and scale the platform to deliver further simplification and drive increased efficiencies as we strive to become a global leader.

Now let's look at some of our recently launched medicines or molecule, starting with Tyenne, our tocilizumab biosimilar, we continue to make great progress leveraging our first-mover advantage. We continue to see excellent market share growth development, which is supported by multiple PBM and health plan contracts, many of which are exclusive.

Turning to Otulfi, our ustekinumab biosimilar, we anticipate incremental sales in Q4 following our exclusive U.S. distribution agreement with CivicaScript. As for our denosumab, we already achieved sales -- little sales in Q3. This is the only biosimilar to offer a subcutaneous 120-milligram prefilled syringe for oncology indications delivering a key differentiation from even the originator and competitors. This product profile really strengthens our competitive position.

In addition, we are pleased to have recently received FDA interchangeability designation for both denosumab products. This allows the medicine to be dispensed at the pharmacy as a substitute for the reference product, creating greater access patient and health care professionals.

Also the FDA's recent draft guidance aimed at streamlining the biosimilar approval process and broadening interchangeability designations in the U.S. is a promising development for patients and payers. But it may have not fundamentally changed the existing framework, we see this as a further support for market growth and expect the U.S. biosimilar landscape to continue evolving positively. For the remainder of the year and into next, we expect the portfolio momentum to continue as contracting agreements convert into prescriptions so watch this space.

Over the past 2 years, what we labeled as in growth factors, they have delivered an impressive 37% EBIT on a CAGR basis and year-to-date, we've achieved an exceptional 18% year-over-year EBIT growth. This performance is underpinned by new products and new innovations, which we will continue to upgrade and scale as part of Rejuvenate.

The growth vectors are performing in line, if not even better than initially envisioned when we launched Future Fresenius. Not only are they driving accelerated top-line growth, but they are also significantly advancing our margin profile. At the same time, our structural improvements to the cost base continue to support margin expansion. The growth vectors, the key drivers behind Kabi's elevated profitability, while our established pharma portfolio remains a strong, resilient and profitable foundation.

Looking ahead into 2026 and beyond, we expect this positive trajectory to continue key drivers here are the increasing contributions from biopharma, sustained product momentum and upcoming innovations in Nutrition, the step up in MedTech profitability, all underpinned by our resilient pharma business.

Now let's turn to the Q3 highlights in our care provision platform, Helios. Overall, the German reimbursement environment continues to be, by and large, supportive. However, for 2026, the projected DRG inflator is anticipated to be approximately 3%, which is lower than initially expected due to a methodology change that favored the lower parameter versus the corridor of the 2 parameters previously used.

This new percentage is broadly in line with the historical median. The onetime invoice surcharge 3.25% with public insurance is an encouraging development. It is effective between November 1, 2025 and October 31, 2026, and is a clear positive supporting several years of previous hospital cost inflation. We continue to remain optimistic about government reimbursement in the coming years, even though recent events would seem to prioritize rather fiscal over health care policy.

At Helios Germany, we remain committed to advancing medical innovation and improving patient outcomes. For example, in Berlin and [indiscernible] in lung cancer centers are pioneering the use of innovative robot-assisted bronchoscopy system. The cutting-edge technology enables earlier and more accurate diagnosis, often unlocking opportunities for life-saving curative treatments, making or marking a true paradigm shift in pulmonology.

In Spain, Quirónsalud continues to demonstrate its strong focus on research and innovation. With 285 new clinical trials initiated year-to-date, including 159 in Phase I and Phase II. This just reinforces its position as a leader in clinical innovation with a best-in-class health care professionals in state-of-the-art hospitals we remain the top choice for patients seeking exceptional care.

I'm excited by our continued EPS momentum through structural cost savings we laid the foundation for transformation. Now in Rejuvenate, we're building on that strong foundation by upgrading the core, scaling our platforms and elevating performance to drive long-term profitable growth. Productivity is no longer just about cost side. It's fueled by growth, new products, innovation and serving the market.

The results speak for themselves from minus 13% EPS growth in fiscal '22, we hit the reset button to double-digit growth today. The transformation has been, I would say, remarkable. My [indiscernible] should be very proud, and we are 1 team, and I would like to say thank you to our entire team.

In the year-to-date, EPS increased by a powerful 14%. This is impressive and has been driven by the continued execution of our future Fresenius strategy, further operational progress and a benefit from reduced interest expenses. Our strong EPS growth is significantly outpacing top-line growth, highlighting our ability to sustainably improve returns and to deliver shareholder value.

We expect this positive trend to continue as we close out the year. The EPS momentum generated by rejuvenate is evident as our growth vectors continue to deliver further profitability improvements. For example, biopharma is gaining significant traction with momentum accelerating going forward.

With that, I'll hand it over to Sara.

Thank you, Michael, and thank you all for joining. Let's start with our financial highlights. Consistent strong organic sales growth, sequentially increase in EBIT growth and a meaningful EPS improvement.

Looking at the top line, Q3 was another strong quarter with 6% organic revenue. Our consistent delivery demonstrates the strength of our business as well as the structural demand for the system critical products and services we offer. EBIT growth was in line with revenue growth at 6% and a nice acceleration from Q2.

Kabi's excellent performance has offset the expected and well flagged Q3 effects at Helios. My KPI this year is our core EPS growth. In Q3, we grew EPS by an impressive 14% and achieved another quarter of double-digit growth, making it 2 out of 3 quarters in 2025. 2 effects came into play. Our strong operating results, combined with a significant year-over-year decrease in interest expense of EUR 35 million.

Following our Q3 financing activities and with the continued focus on interest expense management, we now expect EUR 330 million to EUR 340 million of interest expense for the full year. Our tax rate for the quarter was 24.7%, in line with our expectations for the full year. The leverage ratio at 3x net debt to EBITDA was within our self-imposed target corridor of 2.5x to 3x. More deleveraging is expected before year-end.

Kabi had a strong quarter with a successful and disciplined execution on launch pipeline and rollouts. This resulted in some contributions already materializing in Q3, that were initially only expected in Q4 of this year. Organic revenue grew by 7%, placing it at the upper end of the structural growth range with some additional benefits from pricing effects in Argentina.

The growth vectors remain the primary driver of performance. Biopharma in particular, stood out with impressive 37% organic growth. Nutrition delivered 7% growth, demonstrating the attractiveness and structural strength of this business despite the impact of the key to volume-based tendering in China. Pharma sales increased by 2% organically, relative to a strong prior-year base.

In Q3, Kabi delivered an excellent EBIT margin of 16.7%. This represents roughly 80 basis points on margin expansion year-over-year, including the absorption of the Keto effect. [indiscernible] contributed to the performance. First, the growth factor significantly expanded their EBIT margin year-over-year to 15.9%, moving close to Kabi structure margin range of 16% to 18%.

Second, an excellent profitability at pharma with a margin of 22%. And third, the strong operating leverage due to the disciplined execution and further incremental structural productivity improvements across all business units.

Over to Helios. Our hospital business continues to deliver strong organic top-line growth at 5%. Year-to-date, revenue grew by 6% organically, which is at the upper end of the structural growth band. We delivered solid profitability with an EBIT margin of 7.5% despite the loss of energy release payments and the fluctuations in Spain. Year-to-date, the EBIT margin is at 9.1%.

At Helios Germany, we achieved solid organic growth of 4%, driven by strong acquisition growth and positive pricing effects, balanced by somewhat lower case mix points. This performance also needs to be viewed against the strong prior year base, which included some favorable technical revenue reclassifications.

From an EBIT perspective, margins stood at 8%. And as a reminder, Q3 '24 included the final energy release payment. The performance program is progressing and has achieved over half of the around EUR 100 million target year-to-date. Further significant progress is expected in Q4 with potentially some spillover into next year.

Helios Spain achieved strong organic growth of 7%, driven by a favorable mix of activities and pricing as well as a strong performance in the occupational risk prevention business. With operating leverage at work, the EBIT margin in Spain reflects the usual summer dip. Nevertheless, at 6.6% in Q3 and the margin showed a 20 basis point increase year-over-year. Year-to-date, Helios Spain has delivered a strong margin of 11.3%.

Moving to our cash flow. Again, a strong performance, especially against the backdrop of a tough prior-year comparison. We continue to deliver on our cash conversion ambition. Operating cash flow in Q3 was driven, in particular, by Kabi, contributing approximately EUR 440 million, a great achievement. Helios delivered a robust and reliable Q3 cash flow of around EUR 330 million despite a very tough prior-year comparisons.

Proceeds from our pro rata sale of Fresenius Medical Care shares are included in the cash flow bridge under acquisitions and amounted to approximately EUR 30 million in the quarter. As of today, we have sold approximately 1.5 million shares in conjunction with FMC's ongoing share buyback. ACM cash flow numbers are a testament to the reliability of our cash generation with EUR 2.2 billion in operating cash flow.

When considering free cash flow for the last 12 months, note that dividend suspension in 2024 influenced the prior-year LTM number. Over the past 2 years, we have made significant progress in reducing our leverage by approximately 100 basis points. This deleveraging has been a key driver behind the acceleration of our EPS growth highlighting the focus we've tried on cash flow. Deleveraging remains one of our top priorities within our capital allocation framework. At the same time, we are balancing this with targeted investments aligned with our strategic agenda and strict return criteria to upgrade the core and scale our platforms and ultimately, to create value and deliver long-term profitable growth.

On the financing side, we adopted a forward-looking perspective and capitalize on attractive market windows. With the successful transactions in September, we proactively addressed our refinancing needs for 2025 and most of the first half of '26. We issued 2 EUR 500 million bonds with attractive coupons and concurrently repaid early a EUR 500 million bond with a coupon of 4.25% maturing in May '26.

At the same time, we signed a new EUR 400 million loan agreement with the European Investment Bank, which will be used to support our R&D activities and selective CapEx investments. These activities demonstrate our commitment to managing within our self-imposed leverage corridor of 2.5x to 3x net debt to EBITDA.

With that, let's wrap up Q3 and take a look at Q4, where we expect an acceleration of earnings growth. As mentioned, positive phasing effects have helped our Q3 performance thereby derisking the expected acceleration to some extent. At Helios, we expect a further increase in EBIT contribution due to the performance program in Germany.

In addition, we anticipate to start receiving the surcharge for publicly insured patients, which came into effect on first of November. At the same time, we expect the usual year-end topics, including reimbursement settlements, which may affect EBIT. The fourth quarter will also reflect a year-over-year comparison without energy relief payment.

In Spain, Q4 is typically the strongest quarter of the year, but this is against a tough prior-year comparison. Kabi will continue to absorb the adverse effects from Keto, as well as macroeconomic headwinds, which includes some effects from U.S. tariffs, particularly for MedTech.

However, the strong product launch execution combined with our successful productivity measures, has resulted in an excellent EBIT margin year-to-date. The operational momentum is expected to continue. Given this context, we may deliberately decided to make some incremental investments during Q4, such as in R&D. This aligns well with Rejuvenate to upgrade our core and scale our platforms.

Taking all of this together, what does it mean for our full year guidance. Following our Q2 revenue upgrade, we're now raising our full-year EBIT guidance. Based on the good momentum and disciplined execution in the first 9 months, we now expect group EBIT growth at constant currency to be in the range of between 4% to 8%. Remember that guidance is at constant exchange rates, adjusted for translation effects. We continue to expect FX volatility in Q4, and if current rates persist, revenue and EBIT will each be adversely impacted by approximately 2 percentage points.

In summary, our disciplined execution and strong operational momentum has provided us well for the remainder of the year, with continued focus on delivering sustainable growth, driving productivity and maintaining financial discipline, we are confident in our ability to achieve our upgraded guidance and create long-term value.

Thank you for your attention. And with that, I'll hand back to Michael.

Well, thank you, Sara. As we look ahead, Fresenius is very well positioned to seize the opportunities, which also lie ahead with a strong presence in attractive markets underpinned by a robust secular growth trend, we are committed to sustaining our momentum in driving long-term profitable growth and shareholder value.

Global macro trends, such as rising health care spending driven by aging populations, the prevalence of chronic diseases and the demand for advanced treatments aligned perfectly with our strength. These dynamics present a unique opportunity for Fresenius to deliver innovative solutions prove patient outcomes, while helping to advance cost-effective health care systems. Our strategy remains centered on being a trusted partner to health care providers worldwide.

While we are not entirely immune to external challenges like tariffs or our diversified portfolio and our local-for-local approach provides resilience. Additionally, our strong European hospital business bolstered by Germany's hospital reforms positions us to capitalize on these favorable developments. As Europe's leading hospital provider, we leverage clustering and thereby benefiting from economies of scale, while optimizing our operations and enhance patient care.

Beyond scale, innovation is central to our strategy. We are investing in AI and digital transformation to enhance clinical decision-making, streamlined workloads and improve patient experiences. These next-generation capabilities will strengthen our leadership in medical quality and innovation. Our performance in the year-to-date reflects strong execution across our businesses. Fresenius is now a more focused and agile organization ready to capture the opportunities that lie ahead.

As focus turns to 2026 and beyond, we are committed to leveraging these strengths to deliver long-term sustainable growth creating value for patients, partners and shareholders.

With that, ladies and gentlemen, we'll open up for Q&A.

[Operator Instructions] The first question comes from Oliver Metzger, ODDO BHF.

Yes. The first 1 is on Kabi in particular in Nutrition. So surprising was a quite strong performance in Q3. So was the Keto impact just lower than expected? Or has the remaining business performed better than thought?

Second question on Helios Germany. So in the market, there's still some consolidation ongoing. And yes, there's always this, let's say, quarterly volatility, but can you talk about the volumes? Do you see still the typical 2% volume growth? Or do you recognize just an uptake due to market share gains as we see plenty of hospitals going out of the market?

Yes. Oliver, let's start with the Kabi question. I could make it easy and say yes, the rest performed and performed much not better, but we were able to demonstrate catering underlying demand. And things have to work on all cylinders. This is what happened -- by the way, even in China, outside the national volume-based tenders, there's still some provincial, some regions left where Keto can be catered.

But outside of that one, I mentioned in my speech, 3 new launches worldwide, basically uptick in Europe on an enteral nutrition. But also the U.S., even though it's a low base, but a very strong performance. We started with lipids. Last call, I said we are now adding other things like amino acids and that all yielded to that great performance, which you saw.

And maybe I can take the Helios Germany question. So if you look at the picture in Q3, we actually had a very good activity. Activity growth actually was around 7% However, we did see some, let's say, less complex cases within that activity, which means that if you look at it from a case mix perspective and case weight perspective, there was a 4.4% growth for Q3, i.e., above your 2%.

Okay. And regarding the market share gains, do you see more volumes apart from case?

Market share gains, it's difficult to tell from 1 quarter to another. I think in general, what we see and what we think should be there is a consolidation in the market. We have overcapacity in the market, and we are under focused on quality. So I hope that with the new regulation, we will get more focus on quality, which brings us to our cluster concept and actually hopefully reduces the overcapacity we're seeing and get some kind of productivity into the system as well.

And to maybe add to that one, there is no consolidation opportunity for us. First of all, it doesn't fit our strategy. The second thing is most of the systems or the, let's say, entities, which go out of the system are kind of like broke.

The next question comes from Hassan Al-Wakeel from Barclays.

I will squeeze in 3, please. Firstly, clearly, your guide implies a significant acceleration in Q4. And that has been your consistent messaging year-to-date. But why the wide range with the quarter to go? What are the key pushes and pulls into Q4 and specifically as you head into 2026 on EBIT growth?

Secondly, on the strength in Nutrition at 7%. What are the key drivers here as well as for the broader growth sectors, given the strength in growth vector margin, but also underlying Kabi margin despite higher corporate costs in Kabi and, of course, Keto.

And then finally, on German hospital reimbursement, the surcharge is clearly 1 way the hospital sector is being supported. But does the lower DRG for '26 leave you concerned about the possibility of a similar DRG inflator beyond next year with no surcharge?

Yes. I think let's start with the last one. I think this is crystal ball. We go 1 year to the other, and there have been -- how should I say, this was a very special political situation, where the German government and especially the Minister of Health, let's put it in my words, was under some pressure to rather compromise on fiscal priority than, let's say, public health topics. So I don't think this is a precursor for the next years to come.

On Nutrition that we already alluded to, there's a lot of new products which came to market. And as I said, in China, overall, obviously, the entire numbers have been contracting because Keto was missing, but everything else in all the other regions was firing on all cylinders, especially the U.S. is, again, a small base, but the base keeps growing every quarter. And it will be already a nice pace going into the next year, and it has a nice margin conversion with the 3 chamber bags.

And as I said, now amino acids. And next year, there will be more portfolio amendments to the solution we have. And maybe I'll share later on even a great news, which happened in the last couple of days, also positive for Q4, winning a big private research hospital in the U.S. on not only Ivenix pump, but nutrition, dedicated sets and so on and so forth in the U.S.

Now on the guide, I think it is -- you mentioned it correctly. It is, I think, important to differentiate between the absolute momentum we have and the momentum is just great. And it will continue from an underlying business dynamics in all our businesses, primarily, obviously, Kabi, and we can go through each and every individual business, where the underlying fundamental dynamics in the market, us bringing new products, new innovations in the market, rolling out, expanding will obviously -- we saw it in the first 9 months will happen in Q4 and will go beyond Q4.

So a Q4 close is a year-end close and it's not a cliff. So whatever happens that Q4 does not mean anything in the speed and the dynamics of the underlying momentum is in any way jeopardized. On the contrary, it keeps accelerating. Yet on Q4, it's a year-end, and we need to look at a lot of things -- and this will decide whether 1 thing falls into 1 side or the other side. And then we talk about, I don't know, 10 basis points in the guide. So I would not overemphasize or put too much effort into where exactly we navigate into that guide. There we will update you, but rather look at the underlying trend drivers and that is positive.

Also in Q4, there is biopharma, which is going to expand. Now to which extent, we have to work hard on that one. Q3 biopharma already was a great uptake vis-a-vis Q2, what was it, EUR 195 million, and now we had EUR 228 million or EUR 229 million. And in Q4, even more uptake. So if it all happens, if it happens. If it doesn't happen, it's not falling off a cliff, but it then pushed out to the next year. So this is the moving parts I would kind of like frame the guide. I think there's too much overemphasis on a short-term finding a data point.

The next question comes from Oliver Reinberg from Kepler Cheuvreux.

2 from my side, please. And the first, I wanted to get a bit of color for next year. I mean, I understand, obviously, the guidance will only be provided in February. But I was wondering if you can just talk about the head and tailwinds. I think there's sometimes a bit of excitement building on German Helios obviously facing clearly more favorable pricing. We're going to see the further ramp-up of biosimilars and IV Generics Nutrition also should do well. So can you just talk about what are the kind of headwinds to be called out for next year? Any color here would be great.

And secondly, just on AI. I mean there's a lot of talks on the workflow. You also touched on I was just wondering, can you just give a flavor to what extent does AI also provides a kind of cost savings opportunity in new kind of processes? Is that only playing in kind of a larger role today? And how significant could this be going forward?

Yes. Oliver, I'll try again with the guidance. I think this will be a recurring theme. But the difference is to, let's say, the last 2 years, we're not just leaving you with saying we're going to get there when we get out in February. Obviously, a lot of things can change from now to February. Look at how dynamic the -- not only the end markets are, but the whole geopolitical, geoeconomic framework.

When we started the year with our outlook, there was no talk about tariffs. Then the new administration started and you have the feeling the world is going to collapse with tariffs. We always try to stick with the fact and always be very transparent with you guys as to where we stand and what the impact is. Now where we stand today is different than a couple of months ago because at least there are statements out there that generics and biosimilars may be exempted, but there are still tariffs, which we even absorb in the upgraded guidance.

So what I'm trying to say is there's a lot of moving parts in the regulatory and geopolitical environment, nobody knows what's going to happen. Then we need to have our budget, which we have next week. But again, coming to the big underlying momentum, biosimilars, Rejuvenate, Tyenne, working nicely over the course of the first 9 months. We expect more in Q4, we expect more in going into 2026.

Into 2026, denosumab and ustekinumab, are just being launched in Q4. This is, by the way, also a factor for Q4 where we lend whether it's, I don't know, x million or x plus million, that doesn't matter because the momentum will come next year. This is a full commercial focus on the biosimilar team next year on really on the market and commercialization because there's no new regulatory approval, where we have to work on the documents and so on and so forth.

Nutrition, I said in the U.S. next to what we have now, there will be more elements as in attachment to the portfolio right now. I can talk about compounding, for example. So things are happening, but they need to be then obviously executed. There will be, again, launches on the IV generics side. There will be on the medical technology side, we're actually very satisfied with what we see on the MedTech side also in margin improvement over the course of the last 3 quarters, and this was driven, we have said it in the calls before by the adaptive nomogram, which is software.

Now there will be an annualized kind of impact of the adaptive nomogram going into Q1, Q2 next year. So a lot of exciting things are happening. Obviously, especially Sara we will make sure that the whole organization is disciplined on cost and cash. And then we'll take it from there and update you on the guidance, when we go into next year, again, because it's the beginning of the year, we'll be very transparent with the assumptions. And obviously, I wouldn't say more conservative, but because it's the beginning of the year and then we'll go step by step.

That was it?

AI, sorry, AI. Yes, AI is a topic. Look, we need to differentiate between the industrial side and the hospital side. In the industrial side, I think like many companies, we are embedding AI and AI functionalities and AI agents, with partners into our processes. Kabi has a big program being implemented on further increasing commercial excellence, better managing the sales force, data-driven AI plays a role in there.

We talk about having a few AI pilot projects, which, by the way, are then funded by a central innovation budget, when it comes to speeding up on regulatory approval that plays a role as we move now having a real development machine on biosimilars, but the same holds true for reg affairs on IV generics. So AI can help you there on the documents and all these kind of stuff.

Also in tech ops, when we talk about enhancing the manufacturing product, these are all how should I say, little pilot projects we have. And so this does not entail huge investments. But we are trying it out and on these pilot projects, probably we're going to see the benefit. Where for us, it plays a more nuanced role is on the care delivery side.

There, it is not only about the productivity, efficiency as such with the efficiency, for example, with Quirónsalud, applying AI on doctor-patient conversations. We have a tool called scribe. We are freeing up resources and thereby are able to increase the throughput of patients and concurrently get to better clinical outcome. So we have a few, let's say, functionalities and even agents on that side, but the impact there is obviously 1 of the key levers to drive also the margin up going forward.

The next question comes from Hugo Solvet from BNP Paribas.

I have 3, please. First, maybe, Michael, on the biosimilar, the FDA draft guidance on interchangeability, which you qualified as promising. What could be more concretely the potential impact from lower R&D requirement in the U.S. for your biosimilar business model. Is that a pull forward of sales of profitability? Or will you be keen to reinvest more to gain scale?

Second, we've into biosimilars, sorry, we've seen cutting prices of Humira in Q3? Or do you think this may impact the penetration of non-originator or branded products?

And lastly, maybe 1 for Sara, a quick clarification on the pro rata share sales alongside Fresenius Medical Care share buyback. Could you confirm your selling equivalent of what your stake is? And what the proceeds from that sales are used for? Is it to lower leverage further?

Maybe let me start with the last 1 straightforward. Yes, it's pro rata. So in the end, we will maintain our share relative shareholding in FMC. And actually, I mean, that funding goes into lowering our leverage and into our overall capital allocation. So I think we are fully focused on getting free cash flow up and thereby creating additional headroom for be it lowering our leverage or doing targeted investments into our business.

The second one was a little hard to hear again, I didn't get it 100%. But on the first one, yes, it is a positive development, which we see in the U.S., by and large, all the developments in the U.S., whether it's as a whole tariff discussion, whether it's a deregulation on biosimilars. We're playing exactly into these themes with our portfolio also going into next year.

And it has been already discussed prior, but having enough clinical or scientific evidence so that you don't need to do a Phase III clinical studies, obviously helps to increase the time to market. That is what it's all about. And obviously, to speed up the whole process, make it less complex, less burdensome because there's already a proof of the data.

And the interchangeability, it's a good one. I wouldn't overestimate, but it's just another data point where today, if you want to get interchangeability designation, which we, by the way, have on denosumab you need an extra study. So it's an extra burden, a special name for that study. This is also admitted. So that means that marketplace is very, very, very vibrant.

So yes, if there is any change on R&D, we will immediately reinvest it into the pipeline, into the portfolio. Our strategy is clear to be a fully vertically integrated player. Our biosimilar team calls it a biosimilar powerhouse. And that means you need to have a really robust pipeline, and there is much more coming. The decisive point is the manufacturing because it is a very also a competitive market.

The manufacturing process is a complex process. You need bioreactors. You need to be competitive concurrently, and therefore, you also need to have a nice manufacturing platform. And then the commercialization, also in the last only couple of 3 quarters, 4 quarters has seen many, many changes from national formularies on PBMs. Now we were going to direct health plans we may be going to direct employer plans. We have special deals like the direct distribution deal with Civica, which is a new animal. So we view all of this as you know, opening up the adoption and diffusion of biosimilars.

The next question comes from Veronika Dubajova from Citi.

I have 2, please. The first 1 is just on the profitability of the growth vectors, which obviously, I think is running much better than many of us expected. And I think, Sara, you remarks that you are now very, very close to the 16% to 18% corridor for caveat to have as a whole.

Just curious if you can elaborate on what has been the source of the kind of upside this year from your perspective? And is this that we're starting to hit better profitability in devices? Is it that biosimilar business that's driving this surprise or anything else, if you can kind of give us some color. And I guess as you fast forward, sort of how are you thinking about that Kabi midterm margin guidance, especially for growth factors given the progress that you are making this year in spite of the Keto headwind. So that's kind of my first question.

And then my second question, you're going to laugh at me, I'm not going to ask about 2026. I want to ask about 2027. There has been a lot of debate about whether the invoice surcharge creates a meaningful risk for your Helios profitability as we move into 2027. So I wanted to give you guys an opportunity to touch upon how you're thinking about the benefit from the surcharge when we move into '26 and then how that unwinds into 2027. And I guess simplistically, what your degree of comfort is with the Helios expectations that are in consensus right now for 2027? You are welcome to shut me down, but I got to try.

Veronika, I'm happy to take a go at your 2027 question. I think, first of all, it's fair to say, if you look at the German reimbursement schemes, you have seen that probably since 2019 or even in prior, we always have changes in regulation. We always have during COVID, it was gotten to an extreme, obviously. But since then, we have always had different pockets of funding because we are navigating in an industry which is structurally underfunded hospitals in Germany are actually in the red. So I think there are always some extra pockets as an add-on. I think if you appreciate when the whole topic on surcharge came, it was a surcharge on the DRG inflator and people assume DRG inflator to be similar to last year.

Now as Michael -- actually, as Michael alluded to, it was a very particular situation in which the decision -- in which the discussion on the DRG inflator team about that it was not between the 2 kind of data points, the 5-point something at the 3 points that they opted for the lower end. I think that was a very -- there was a decision taken in a special situation.

Now where does it leave us? Simply and I only go from a pricing perspective now simply if you take the surcharge and what may most likely become the DRG inflator, you are close to where we are this year around in terms of math. Now does that leave us with a cliff because the surcharge will go away. I would say that so far, we have always experienced that as we operate in a sector which is chronically under financed that there will be new pockets opening we hope, I think that is our institutional expectation that we see regulation, which gives us more clarity and longer-term perspective because obviously, we are navigating an environment, which is not helpful to have those pockets shifting year-over-year.

But I think also you can rely on, if you look at the Helios performance, we have managed that quite well historically. Irrespective of what those reimbursement schemes were, I think we were the ones, who were relatively adaptive to it from the start. So bottom line, am I concerned about the cliff? No, I am not. There will be other pockets of value and funding because they need to be in the structure we currently operate in.

Yes. I think that was a very perfect answer, and Veronika, probably what is also behind the question for your clients and hopefully, our investors, are we afraid of regulatory going up and down and so on and so forth in a business which we actually deem is very reliable and stable, and Sara just gave the answer.

The fact of the matter is that roughly 80% of German hospitals are in red ink. So either they support the whole system via these mechanisms or they will go out of business, and then we will catch the patients. And we have the cluster concept, and that is why we are hitting so much on driving our program irrespective of regulatory changes that we are ready to have the best capacity utilization of our in essence, infrastructure assets and with the help of digitization, which we see in Spain works, navigate patients through complex and less complex cases.

Now with regards to where is the Kabi margin band, well, this is also something we've got to look at that 1 when we go out next year or maybe the year after or in between, this is an involvement I really wanted to remind everybody where we started. We started with the 15% to 17%, and the margin of the overall Kabi business was below that margin band. If you look at the makeup of the Kabi EBIT contribution today, it's almost half-half growth vectors versus the base business, which is also contributing and growing. So that has been the strategy all along and will remain the strategy.

The only point now in rejuvenate is this new innovative things which we have on for the last 2 years, 3 years, even are now coming to market. Let's go through them one-by-one. Medical technology or MedTech, of course, they have a program, which is a competitiveness program, they call it above and beyond. But also going on new products, like I said, adaptive nomogram.

Adaptive Nomogram is software and in parts recurring revenue. And it's a new thing, and it's picking up, and there will be a pickup in Q3, Q4. And then we will come up with what lies behind -- beyond that one in the end of '26 or '27. Ivenix, yes, we know that we have, let's say, some homework to do in industrializing that one. But the market demand, the customer demand, the customer feedback is enormous.

I just shared with you that we just received a contract from a large private research hospital in Florida on x amount of Ivenix pump together with solutions, together with Nutrition, together with dedicated and non-dedicated sets, which shows you how we can deepen also on customer engagement with the portfolio we have.

Biosimilars has been driven primarily by Tyenne this year and will be driven by Tyenne next year, by the denosumab, by ustekinumab, by still adalimumab, by Map Science, their partners selling bevacizumab, pembrolizumab. And to some extent, if we really achieve at some point, the fully vertically integrated biosimilar powerhouse, then the milestone payments will play a minor role already in the makeup of the whole thing. Today, they play a minor role compared to what the molecules are catering. So thereby, it remains what we said the dynamics is great.

Maybe, could I -- sorry, if you like, Veronika, happy to give you some feedback on Q3, which indeed was a good one, 15.9% margin. If you look at it, it derives from really the volume of top line development, we have seen in pieces of some nice price development overall, it was a good mix.

There were some milestones on biopharma. And also don't forget, we do have a very strong cost and efficiency discipline in there as well, which also helped the margin this quarter.

We've got 3 participants left. So if we can encourage them to stick the 1 to 2, then hopefully, we can be finished in the next 15 to 20 minutes. So I think Graham Doyle, UBS. Over to you, please. Graham?

Okay. Perfect. Yes, I can stick to 2. Michael, just on the sequential improvement in biopharma, just kind of help us model. You were up kind of $40 million in Q3. Is that sort of what we should be thinking for Q4 just help us to model as we then ramp into next year?

And then the second question is around the German surcharge. Would next year be a good year maybe to do some of these kind of interesting investments and maybe pull forward something from, say, '27 to help kind of smooth the numbers through the year. Is that something you could do?

You want to start with the second one.

If I got it correctly on investments on -- you mean for the overall group. Yes. So overall...

Exactly.

Look, I think on the -- and I wouldn't make it on the surcharge to be very honest, because we said if you take surcharge plus what's currently in debate on the DRG, you're not too far off from what we've seen in this year's DRG. But coming back to what Mike has said is, we see a very strong momentum in all our businesses. We see a lot of positive momentum on the Kabi's side, but we also, with the company program coming to fruition and some annualization effects in '26. There should also be some positive effect on the Helios side.

If you take all of that together, of course, in the context of Rejuvenate, we will step up our investment focus. And I think on capital allocation, I said deleveraging will remain core. But at the same time, we balance that with deliberate investments. And maybe even Q4, if I look at the momentum we currently see and where we are on the Kabi side year-to-date, maybe we may take some decisions to do some incremental investments also in Q4 because in the end, it's about fueling our pipeline with a step-up in R&D with step-up in CapEx and will step up in other investments, and we are prepared to do that.

Yes. And then Graham, I can make it short, so that the others have time, the EUR 40 million may be a bit too high fetched. I mean, already going from Q2, as I said, which was the EUR 40 million. There will be incremental sequential growth, but $40 million, maybe twice.

The next question comes from Falko Friedrichs from Deutsche Bank.

Let me keep it to one. It's on the pharma margin within Kabi trending around 22%. And at the CMD, you said around 20% is a reasonable level for the business. So is 22% the new 20% for this business? Or is this just an extraordinary year and sort of starting next year, we should be eyeing rather than 20% again?

Yes. Well, we can make that 1 short. We said by and large, take a ruler and take 20%. There can be quarters where it's higher. There can be quarters where it's lower. The Q3 number was quite strong, because we decided to go for commercial batches rather than stability batches.

That is what Sara also alluded to R&D type of things, investments in Q4. So stability batches, as you know, are needed for future launches, products, which is future revenue, which will come in which we took a deliberate decision to take it into Q4 and rather give the capacity to commercial batches. That is, in essence, in Q3.

The next question comes from David Adlington from JPMorgan.

Great. Maybe 2 related to the last question, really. The year-to-date margin for Kabi 16.6% and that you kept the 16% to 16.5% full year range. If you pulled out some needs some investments potentially, I'm guessing on the R&D side in Kabi. Is that why you haven't increased the range for the full year? And maybe just some help around how we should be modeling that fourth quarter margin?

So I think if you look at where we stand today, I think how we had a very strong performance in terms of margin, but it's the underlying momentum we are seeing, which is strong. Now if you look at Q4, as Michael said, there is its year-end. So a, yes, we will take the freedom to take potentially some investment decisions. B, there was some more positive phasing in Q3, where things came earlier than initially anticipated.

And then as the business turns to year-end. Obviously, there are topics whether we post the batch end of December or beginning of January doesn't really change the underlying momentum of the success of the business. And of course, around year-end, you have customers wanting something from not wanting something you have suppliers wanting something from us or not wanting something from us. You have final settlement, final invoices and so on. So it's just a quarter which we will diligently work through, but we don't see a change in the underlying momentum.

Okay. That was our last question. Thank you, David. Michael, if there's anything you want to conclude with otherwise...

No, I would want to conclude with reiterating, where also Sara left it, look at the business, look at the underlying momentum, which is in the each and every individual business. This is a strong momentum, which is going to carry also into 2026, and then we'll take it from there.

Super. Thank you very much. We can conclude the call there, and we look forward to seeing you folks in Paris tomorrow.

We want to thank Fresenius and all the participants for taking part in this conference call. Good bye.