Fresenius SE & Co. KGaA

Fresenius SE & Co. KGaA

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Q4 FY2025 · Earnings Call TranscriptFebruary 25, 2026

Operator

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

Niklas Stone

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 emailed to our distribution list earlier today and is available on fresenius.com. On slide 2 of the presentation, you will find the usual safe harbor statements.

Unless stated otherwise, we'll comment on our performance using constant exchange rates, or CER. Today, I'm pleased to welcome Michael and Sarah, 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 the presentation taking between 35 to 40 minutes, and remaining time for your questions. To give everyone the chance to participate, please limit your questions to one or two in the first instance, and we can always come back for a second round as needed.

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

Michael Sen

Yes, very well. Thank you, Nick, and 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 Future Fresenius strategy, #FutureFresenius, 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 3 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 healthcare 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 2.7x. We're now well within our self-imposed and improved leverage 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 organization faster, leaner, and more resilient. Return improvement and deleveraging remain central to value creation.

Importantly, the transformation is energizing our teams across the company. Engagement is rising, and 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 €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 delivery remains a priority, supported by the ramp-up of our Wilson, North Carolina site, further strengthening our IV fluids 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 FloCorp 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 deglobalization, means that we're also looking at our global value chains and 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, 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 US Supreme Court ruling. Tariffs remain fluid, but Fresenius is well positioned with 90% of group revenues unaffected by US tariffs and 70% of our US 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.

We expect continued operating leverage, with EPS growing significantly faster than the top line. #FutureFresenius is about innovating our portfolio, about keeping our portfolio young and relevant.

The progress of our Kabi portfolio demonstrates this impressively. More than half a 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 band.

Let's turn to Biopharma, a core engine of our #FutureFresenius agenda and a key catalyst of our performance acceleration. We continue to see excellent momentum in our portfolio 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. Uptake 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 UK and 17% in the US, 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 mg single-dose vial, which provides dosing flexibility for pediatric patients.

Adoption continues to build, strengthened by our exclusive US 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 ustekinumab autoinjector presentation.

This is, all in all, excellent news. Our denosumab biosimilar is progressing as planned.

In the US, 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 to continue into 2026 and beyond as existing contracts increasingly convert into prescriptions and the broader tailwinds behind biosimilar adoption continue to strengthen. The performance of our recent launches gives us confidence in exactly that trajectory.

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 towards an EBIT margin of around 20%. This will be driven by further launches, deeper penetration, and continued cost efficiencies across the portfolio.

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 turn to our 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 healthcare.

Through #FutureFresenius, we're 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're 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 three 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 innovative 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. #FutureFresenius is now fully underway.

When you look at where we began our Future Fresenius journey just over 3 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 #FutureFresenius 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. 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 US 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 Sarah.

Sarah Hennicken

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 at Helios.

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 revisions 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 €1.3 billion. Our strong cash conversion supported the deleveraging, bringing us well within our self-imposed target range of 2.5 to 3.0x 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 times of rising geopolitical uncertainty and despite meaningful macro effects.

Our results and phasings also played out just as we set out at the beginning of the year. I'm very proud of the entire Team 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 US, volume growth more than compensated for pricing pressures.

Argentina hyperinflation and the resulting price effect 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 investments and year-end effects, as expected.

Against these effects and despite the keto impact in China, Q4 margin remained on prior-year level, demonstrating the underlying strength of the business. This was driven by ongoing growth vector 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 band.

EBIT margin stood at an excellent 11.7% at the top end of the structural margin band, also here, 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 performance standout 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 months 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 €560 million over the last 12 months. We enter 2026 with strong foundations, and we 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 band.

Today, we are further raising the bar to 17% to 19%. Consistent margin expansion of 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%.

For 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 2 years, we've reduced net debt by around €3 billion, representing around one-quarter of our net debt. This has been achieved primarily on an organic basis, driven by stringent focus on cash and a strong earnings performance.

Having regained financial flexibility, we now have strategic optionality as we advance our #FutureFresenius 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 €1.05 for full year 2025. This represents a 5% increase year-on-year, with distribution at 37% of core net income towards the upper range of our policy.

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 3.0x, and staying fully committed to our investment-grade rating. This means strong discipline on capital allocation and cash conversion.

#FutureFresenius 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 #FutureFresenius, 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 #FutureFresenius, 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 €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 2 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've structurally strengthened Fresenius' earning 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, and as an additional help, let me share building blocks of our outlook and indications for the segments. Kabi will continue to build on its strong operating momentum in 2026.

We're expecting a ramp-up over the course of the year as rollouts and launches are being executed. The keto 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 #FutureFresenius 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 the 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 31st 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.

With that, I hand it back to Michael.

Michael Sen

Thank you, Sarah. Now let's take a step back and look at healthcare systems and the dynamics of healthcare systems more structurally.

Globally, healthcare 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, healthcare 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. We need to continue to invest for future success.

We play a system-critical role through essential medicines, generics and biosimilars, and healthcare infrastructure that expands access to high-quality, affordable care and supports healthcare 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 healthcare security, particularly in key markets like the US. 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 embed 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 healthcare franchise for the future, leveraging scale, innovation, and resilience to deliver sustainable, profitable growth and long-term value for patients, partners, and shareholders. With that, we're happy to take your questions.

Operator

We are now starting the question-and-answer session. If you like to ask a question, please press star followed by one on your touch-tone telephone.

The operator will announce your name when it's your turn to ask a question. In case you wish to cancel your question, please press star followed by two.

The first question is from Hassan Al-Wakeel from Barclays. Please go ahead.

Hassan Al-Wakeel

Thank you. Good afternoon.

I have a couple of questions, please. Firstly on Helios, your guidance assumes around 100 to 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, but then also in 2027 as this rolls off?

Then secondly, 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?

Thank you.

Michael Sen

Thank you, Hassan. I'll start with your second question, and then we'll lead to the second one, and Sarah 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 yours, 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're 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. Then 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 US, 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, but 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 2027.

Now 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, and 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, and 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 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. The volume comes through launches, the volume comes through working and converting where we have framework 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 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. Now let's assume, which is not our base case, the revenue is only moving up slowly, then this management team is ready to take cost measures, 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.

Then 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?

Sarah Hennicken

On the Helios, let me try and also give you a little bit of a more comprehensive answer 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%.

Now going into 2026, the DRG inflator is set at 2.98%. From 5.9% to 2.98%.

However, 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 technical effect, that part of that price increase will sit under other income, i.e.

just below the revenue line. Then if you look into 2026, you assume the price tag roughly the same, and then 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, 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 which, if you look at it, there is hybrid DRGs.

They were introduced in 2024. It's fair to say there's 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 and how that will all unfold. We're starting off with a DRG of around 3%, and 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 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 reinstated.

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 points 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 on to our company program.

For 2026, I think we have given you a really nice margin expansion perspective on Helios. Next question.

Hassan Al-Wakeel

Very comprehensive. Thank you.

Operator

The next question comes from Oliver Metzger from ODDO BHF. Please go ahead.

Oliver Metzger

Yes, good afternoon. Thanks a lot for taking my questions.

The first one is very quick one. Does the exceptional strong growth of a 97% in Biopharma consists of any one-off effects or pull-forward effects, which could mean that Q1 might be softer from an extra 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 trend to treat more patients outside the clinics. 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 digitization and efficiencies activities you're doing and also the lower described invasiveness.

Thank you.

Michael Sen

Oliver, hi. I'll I'll start with your Kabi question on on bio.

They had a very, very strong Q4, particularly by the by the US. I was very pleased to see that under the special distribution agreement with CivicaScript, we did see the first revenue postings.

That was 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, 6 million milestone payment year-over-year which will be lacking from Mabxience, but that is only a Q4 a Q1 kind of topic. Overall, the 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. There are lots of molecules.

We have Deno, we have Uste, we have Tyenne, and many others, and as I said, the pull-through and everything has to come. Yet, don't forget, and disclose 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 defended exclusivity, and that all has to work. That one on the biosim.

The Helios?

Sarah Hennicken

Yep. 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.

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 unfold in terms of how many cases will be moving, I think that we will see as the year unfolds a little bit.

There have been let's say hernia repair or urology, which have been on the menu already in 2025. There 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.

Oliver Metzger

Thank you.

Operator

The next question comes from Veronika Dubayova from Citi. Please go ahead.

Veronika Dubayova

Hey, guys. Good afternoon.

Hope you can hear me okay, and thanks for taking my questions. I have two, please, and apologies if I've missed this a little bit, but just want to 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. Then just a quick question if I can ask around the Kabi margin corridor.

Sort of if I look at the 17% to 19%, 80% to 85% of the business is already, or, given the guidance you've given us, should be operating at 20%. How should we be thinking about the progression in medical devices?

Thanks so much.

Michael Sen

Maybe just to put the statement into perspective, I think that fits very well in what Sarah outlined on the overall '25, '26 Helios kind of buckets they're 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 100 million was actually executed, we would say, to plan. They brought home what they have been saying.

Now having done a few of these programs myself in the past, I looked at it, I started the first one 2001. Usually you also sometimes actually have a buffer, operationally, internally.

Now what has happened is with the DRG inflator, what Sarah 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 the surcharge.

At the end of the day, it would have been the same if they had taken the higher end, but 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, and then obviously to manage the patient flow in order to manage the case mix, yeah, because we have not talked about the case mix, or Sarah did talk about the BVR, that case mix is also one element which contributes to the margin. Kabi, yeah, 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're hinting at there's a culprit with MedTech, MedTech, over the last 3 years, meaningfully improved their margin by a couple of hundred basis 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 once 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 with being fully vertically integrated. Okay?

Operator

Next question, please. The next question comes from Hugo Solvet from BNP Paribas.

Please go ahead.

Hugo Solvet

Hi. Thank you for taking my questions.

Congrats, Michael, on continuing the journey until 2031. That's 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? What are your thoughts on the risk that significantly lower cost could lead to more competition or lower the barriers to entry?

Second, maybe more for Sarah, 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?

Thank you.

Michael Sen

Yeah. Thank you, Hugo, also for your kind words.

Look, on biosim, that's why I was mentioning, I think all we see, particularly in the US, is headed in the right direction. You had the FTC enforcement, and 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. The copay of the individual patient in the US is also based on that list price.

The incentive is the higher the rebate on I'm talking about 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 has been experiencing already in contracts where we had this direct channel, direct health plans, special distribution deals, unbranded 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, and 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, $30 million or something like that.

You need to invest already into that one. I think it's headed into the right direction.

Maybe before I hand it over to Sarah, maybe on Veronika's question on the margin for Kabi, what I would also emphasize is that we are investing also in innovation. 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?

He 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 investment going into OpEx.

Sarah Hennicken

Yeah. Now happy to take the question on US 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 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 will continue to see a nice ramp-up into 20 We have seen in 2025, and we'll 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 into '26. Now if you talk about price pressure per se, Q4 was probably a little bit more pronounced than 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 it's portfolio and pipeline, and in 2025, we have been quite successful with our 15 launches and building on that one.

It's also the reliability of supply. I think there we also stroked really nice wins and winning awards from 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. That's how you manage the the price.

Michael Sen

By the way, why are we confident on that one? There is market share to be gained.

We have seen market share gains on solutions because we're talking about Wilson and solutions, and we want to pick up more. Again, that then needs to work.

If that works, then it gets volume. Market share is there to be picked up because, as you probably know much better, many customers may want to diversify their supplier base.

Next question, please.

Operator

The next question comes from Falko Friedrich from Deutsche Bank. Please go ahead.

Falko Friedrich

Thank you. Two questions, please.

Firstly, with your leverage ratio now at 2.7x, 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?

Thank you.

Michael Sen

I'll start with the second one, and then Sarah, which I think she already outlined nicely in her speech, but Falko, we'll repeat it again. Not so sure on the M&A.

We will 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, even if you take a like-for-like, then you would have a full-year annualized tariff impact going into '26. Now how that then changes with the new ruling, we will have to see.

Sarah Hennicken

Yeah. 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 #FutureFresenius 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 #FutureFresenius 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 because 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.

Then we will decide project by project with a view on those two whether it makes sense to invest more into funding our own innovation or whether we go to the outside and insource certain things. Overall, with #FutureFresenius, we have kicked off the next leg, if you so wish, of fostering that investment is also reflected in a higher CapEx of 5.5% of revenue.

However, 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.

Michael Sen

Valentina, could we take one last question as Anna Lizzul of Bank of America sneaked in at the very end? Guys, line up, please.

Operator

Sure. Anna, your line is open.

Please go ahead.

Hi. Thank you so much for squeezing me in.

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. Thanks again for taking my question.

Michael Sen

Yeah. 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 insourced, 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 Clinics, 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 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 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 Sarah 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.

Great.

Operator

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

Michael Sen

Yeah. 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 3 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, 500 million, half a 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 investments 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're confident that it will come because many things are backed by contracts. We have great visibility.

The margin for error there is not huge, but customers pull through when they pull through. Supply chains need to work when they need to work.

This is at the beginning of the year where we maybe 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.

Operator

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