Fresenius Se & Co

Hello, everyone. Welcome to our year-to-date NQ3 earnings call and webcast. The presentation was emailed to our distribution list earlier today and is available on Fresenius.com. On slide two 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 CR. Today, I'm delighted to be joined by Mike and Sarah, who will take you through the EBIT guidance rate and the disciplined execution that drove the continued performance this quarter. As usual, the call will last approximately one hour, with the presentation taking around 25 to 30 minutes, with the remaining time for your questions. To give everyone the chance to participate, please limit your questions to one to two only. We can always come back for a second round if needed. And with that, I will now hand the call over to Michael.

Yeah, thank you, Nick, and welcome to everyone joining us on a very, very busy day. You know, exactly three years ago, we hit the reset button and then embarked on the 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 and 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 here 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 CABI 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. You know, 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 and 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 Kavi. In pharma, we have further focused and simplified the business with the successful divestment of the Calier 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 for essential medicines and technology. It also recognizes the more than one billion we have invested over the several years to strengthen our capabilities and support for the U.S. healthcare system. We will continue with U.S. investment to support the healthcare 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 three 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 access 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 Denusomab, a key milestone was achieved with CMS issuing permanent and product-specific billing codes, the HCPCS 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 tie-in vials to European countries from our MAP science plant in Argentina. We've 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 healthcare solutions. CABI remains at the forefront of innovation, operational excellence, and patient care. Now let's take a closer look at our resilient and very strong foundation. Our highly cash-generative pharma business continues 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 medicine list, underscoring our critical role in healthcare 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 break-even, marking its transition into a scalable, fully operational platform. With MapScience, 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 MapScience 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 molecules. Starting with Tayana or Totsilizumab 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 Atulthi, our Ustekinoma biosimilar, we anticipate incremental sales in Q4 following our exclusive U.S. distribution agreement with Civica Script. As for our Denusoma, we already achieved sales, little sales in Q3. This is the only biosimilar to offer a subcutaneous 120 milligram pre-filled 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 Denusumab products. This allows the medicine to be dispensed at the pharmacy as a substitute for the reference product, creating greater access for patients and healthcare 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. While 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 in 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 two 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 rejuvenating. 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 Carby's elevated profitability, while our established farmer 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, you know, by and large supportive. However, for 2026, the projected DOG 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 two parameters previously used. This new percentage is broadly in line with the historical median. The one-time invoice surcharge of 3.25% with public insurance is an encouraging development. It is effective between November 1st, 2025 and October 31st, 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 remains committed to advancing medical innovation and improving patient outcomes. For example, in Berlin and Wiesbaden, lung cancer centers are pioneering the use of innovative robot-assisted bronchoscopy systems. The cutting-edge technology enables earlier and more accurate diagnosis, often unlocking opportunities for life-saving curative treatments, marking a true paradigm shift in pulmonology. In Spain, Kiran Salud continues to demonstrate its strong focus on research and innovation with 285 new clinical trials initiated year to date, including 159 in phase one and phase two. This just reinforces its position As a leader in clinical innovation with best-in-class healthcare professionals and state-of-the-art hospitals, we remain the top choice for patients seeking exceptional care. I am 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 colleagues should be very proud, and we are one 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 Sarah.

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%, a nice acceleration from Q2. Kavi'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 two out of three quarters in 2025. Two effects came into play. Our strong operating results combined with a significant year-over-year decrease in interest expense of 35 million euros. Following our Q3 financing activities and with a continued focus on interest expense management, we now expect 330 to 340 million euros 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 three times net debt EBITDA was within our self-imposed target corridor of two and a half to three times. More deleveraging is expected before year end. Kabi had a strong quarter with a successful and disciplined execution on launch pipeline and rollout. This resulted in some contributions already materializing in Q3, that were initially only expected in the fall 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 remained the primary driver of performance. Biopharma in particular stood out with an impressive 37% organic growth. Nutrition delivered 7% growth, demonstrating the attractiveness and structural strength of this business, despite the impact of the keto 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 K2 effects. Three factors contributed to the performance. First, the growth factor significantly expanded their EBIT margin year-over-year to 15.9%, moving close to CABI's structural margin range of 16% to 18%. Second, and excellent profitability at Parma 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 relief payments and the recent 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 admission 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 relief payments. The performance program is progressing and has achieved over half of the around 100 million euro 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, the margin shows 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 ambitions. Operating cash flow in Q3 was driven in particular by Carbi, contributing approximately 440 million euros, a great achievement. Helios delivered a robust and reliable Q3 cash flow of around 330 million euros, despite a very tough prior year comparison. Proceeds from our pro-rata sale of resilience medical care shares are included in the cash flow bridge under acquisition and amounted to approximately 30 million euros in the quarter. As of today, we have sold approximately 1.5 million shares in conjunction with FMC's ongoing share buyback. LTM cash flow numbers are testament to the reliability of our cash generation with 2.2 billion euros 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 two 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 place on cash flow. The leveraging 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 capitalized 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 2026. We issued two 500 million euro bonds with attractive coupons and concurrently repaid early a 500 million euro bond with a coupon of 4.25% maturing in May 2026. At the same time, we signed a new 400 million euro loan agreement with the European Investment Bank, which will be used to support our R&D activities and selected CapEx investments. These activities demonstrate our commitment to managing within our self-imposed leverage corridor of 2.5 to 3 times net debt 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 de-risking 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 third surge for publicly insured patients, which came into effect on 1st 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 payments. In Spain, Q4 is typically the strongest quarter of the year, but this is against a tough prior year comparison. CAVI will continue to absorb the adverse effects from Cato 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 decide 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 also raising our full year EBIT guidance. Based on the good momentum and disciplined execution in the first nine months, we now expect group EBIT growth at constant currency to be in the range of between 4% to 8%. Remember that guidance is that constant exchange rates adjusted for translation effects. We continue to expect ethics volatility in Q4, and if current rates persist, revenue and EBIT will each be adversely impacted by approximately two percentage points. In summary, our disciplined execution and strong operational momentum have provided as 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, Sarah. 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 healthcare spending driven by aging populations, the prevalence of chronic diseases, and the demand for advanced treatments align perfectly with our strength. These dynamics present a unique opportunity for Fresenius to deliver innovative solutions, improve patient outcomes, while helping to advance cost-effective healthcare systems. Our strategy remains centered on being a trusted partner to healthcare 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 enhanced patient care. Beyond scale, innovation is central to our strategy. We are investing in AI and digital transformation to enhance clinical decision-making, streamline workloads, and improve patient experiences. These next generation capabilities will strengthen our leadership in medical quality and innovation. Our performance in the year today reflects strong execution across our businesses. Presenius 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.

We're now starting the question and answer session. If you'd 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 comes from Oliver Metzger of the BHF. Please go ahead.

Yeah, good afternoon. Thanks a lot for taking my questions. The first one is on carb and particularly on 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 is still some consolidation ongoing. And 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? Thank you.

Yeah, 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, you know, we were able to demonstrate catering underlying demand and, you know, 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 Cato can be catered. But outside of that one, you know, I mentioned in my speech three new launches worldwide. basically, you know, up-pick in Europe on 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.

Maybe I can take the huge 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 the case?

The market share gains is difficult to tell from one 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.

Yeah, clear. No, thank you very much.

Thanks.

The next question comes from Hassan Al-Bakil from Barclays. Please go ahead.

Good afternoon, Michael, Sarah, and Nick. Thank you for taking my questions. I will squeeze in three, 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 a 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, you know, for the broader growth factors, given, you know, the strength in growth factor margin, but also underlying CAR-B margin. despite higher corporate costs in Carby and, of course, Quito. And then finally, on German hospital reimbursement, the surcharge is clearly one 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? Thank you.

Yeah, I think let's start with the last one. I think this is crystal ball. We go one year to the other and there have been, how should I say, there 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 priorities than, let's say, public health topics. So I don't think this is a precursor for the next years to come. On nutrition, 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.S. again. a small base but the base keeps growing every quarter and it will be already a nice base going into the next year and And it has a nice margin conversion with the three 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 in the last couple of days, also positive for Q4, winning a big private research hospital in the U.S. on not only Ivonex 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. This is 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 nine 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 at Q4 does not mean anything in the speed and the dynamics of the underlying momentum is in any ways jeopardized. On the contrary, it keeps accelerating. Yet on Q4, it's a year end and we need to look at a lot of And this will decide whether one thing falls on one 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, you know, trend drivers, and that is positive. Also in Q4, there is biopharma, which is going to expand. Now, to which extent You know, we have to work hard on that one. Q3, biopharma already was a great uptake vis-a-vis Q2. Q2 was, what was it, 195 million, and now we had 228 or 29 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's 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.

Very helpful. Thank you.

The next question comes from Oliver Reinberg from Kepler-Chevreau. Please go ahead.

Oh, yes, thanks very much for taking my questions. Two from my side, please. 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 a clearly more favorable pricing. We're going to see the further ramp-up of biosimilars, and average and average nutrition also should do well. So can you just talk about what are the kind of headwinds that are to be called out for next year and the color here would be great. And secondly, just on AI, I mean, there's a lot of talks on 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 already playing a kind of larger role today and how significant could this be going forward? Thank you.

Yes, Oliver, I'll try again with the guidance. I think this will be a recurring theme. But the difference is to, you know, let's say the last two 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 not only the end markets are, but the whole geopolitical, geoeconomic frameworks. When we started the year with our outlook, there was no talk about tariffs. Then the new administration started and you had the feeling the world is going to collapse with tariffs. We always tried to stick with the facts. 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, tie in, working nicely over the course of the first nine months. We expect more in Q4. We expect more in going into 2026. Into 2026, the Nuzo map and Ustekino map are just being launched, you know, in Q4. This is, by the way, also a factor for Q4 where we land, 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, you know, 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, you know, 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 generic cycles. There will be on the medical technology side, we're actually very satisfied with what we see on the medtech side also in, you know, margin improvement over the course of the last three years. quarters. And this was driven, we have said it in the calls before, by the adaptive nomogram, which is software. Now, you know, 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 Sarah will make sure that the whole organization is disciplined on cost and the and cash and then we'll take it from there and upgrade update you on the guidance when we go into next year again because it's the beginning of the year we'll be very very transparent with the assumptions and obviously uh i wouldn't say more conservative but because it's the beginning of the year and then we'll go step by step so is it So AI, sorry, Oliver, AI. Yeah, 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 technologies. agents with partners into our processes. Kavi 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, you know, 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, these are all how should I say, little pilot projects we have. And so this does not entail huge investment, 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 Kiran Salute, 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 outcomes. So we have a few, let's say, functionalities and even agents on that side, but the impact there is obviously one of the key levers to drive also the margin up going forward.

Go ahead, Paul. Thank you, Michael.

The next question comes from Hugo Solvay from the NPA Paribas. Please go ahead.

Hi, hello. Thank you for taking my questions. I have three, please. First, maybe, Michael, on the biosimilar, the FDA draft guidance on interchangeability, which you qualified as promising. What could be more concurrently 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 seen a V on biosimilar still, sorry. We've seen a V cutting prices of Humira in Q3. Or do you think this may impact the penetration of non-originator branded products? And lastly, maybe one for Sarah, a quick clarification on the ProRata share sales alongside Fresenius Medical Care share buyback. Could you confirm your selling equivalent of what your stake is and what what the proceeds from that sales are used for. Is it to lower leverage further? Thank you.

Hi. Maybe let me start with the last one, straightforward. Yes, it's pro rata. So in the end, we will maintain our share. uh relative shareholding in fmc um and actually i mean that funding goes into uh lowering our our leverage and into our overall capital allocation yeah 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 the whole tariff discussion, whether it's deregulation on biosolids, We're playing exactly into these themes with our portfolio also going into next year. And it has been already discussed prior, but, you know, having enough clinical or scientific evidence so that you don't need to do a phase three 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 proof of the data there. 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 the NUSO map, you need an extra study. So it's an extra burden, a special name for that study. This is also emitted. 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 competitive market. The manufacturing process is a complex process. You need bioreactors. You need to be competitive concurrently. and so therefore you also need to have a nice manufacturing platform and then the commercialization also in the last only couple of three quarters four 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 Veronica Dubajova from CT.

Please go ahead. Hi, Michael, Sarah, Nick, thank you for taking my questions. I have two, please. The first one 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, Sarah, you've remarked that you are now very, very close to the 16% to 18% corridor for CABI 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 that by a similar business that's driving the surprise or anything else, if you can kind of give us some color? And I guess as you fast forward, how are you thinking about that copy midterm margin guidance, especially for growth vectors, 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 that you're going to laugh at me but 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 cliff for your helios profitability as we move into 2027 so i wanted to give you guys an opportunity to touch up on 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. Thank you.

Hi, Veronica. 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 prior, we always had changes in regulations. We always had, 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. 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 a DOG inflator and people assumed DOG inflator to be similar to last year. Now, as Michael alluded to, It was a very particular situation in which the decision or in which the discussion on the DRG inflator came about that it was not between the two kind of data points, the five point something and the three point 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, you're 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 undefined, 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 perspectives, 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, 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 a 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 Veronica, probably what is also behind the question for your clients and hopefully our investors, are we afraid of the regulatory, you know, going up and down and so on and so forth in a business which we actually deem as very reliable and stable? And Sarah 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'll 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're ready to, you know, have the best capacity utilization of our, in essence, infrastructure assets. And with the help of digitization, which we see in Spain works, you know, navigate patients through complex and less complex cases. Now, with regards to where is the CABI margin band, well, this is also something we got to look at that one 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 a 15% to 17%, and the margin of the overall CABI business was below that margin band. If you look at the makeup of the CABI, 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 for the last two years, three 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, you know, 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 pickup in Q3, Q4. And then we will come up with what lies beyond that one in the end of 26 or 27. Ivonex, 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 IV and X 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 TAIEN this year and will be driven by TAIEN next year by Denuso Map, by Ustekino Map, by Still Adalimo Map, by MapScience, their partners selling Bevacizzo Map, Pembolizzo Map. 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, sorry, could I, if you like, Veronica, happy to give you some feedback on Q3, which indeed was a good one, 15.9% margin. You know, if you look at it, it derives from really the volume of top-line development. We have seen in pieces 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 three participants left, so if we can encourage them to stick to one to two, then hopefully we can be finished in the next 15 to 20 minutes. So I think Graham Doyle at UBS, over to you, please.

Graham, questions? Oh, yeah. I am not on mute. You're good. You're good. You're good. Okay, perfect. Thanks, guys. Yeah, I can stick to two. Michael, just on the sequential improvement in biopharma, just to 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 years? Is that something that you could do? Thank you. You want to start with the second one?

If I got it correctly on investments, you mean for the overall group? Yeah, for overall groups. Exactly, exactly. Look, I think, and I wouldn't make it on the third charge to be very honest, because we said if you take third church plus what's currently in debate on the DRG, you're not too far off from what we're seeing in this year's DRG. But coming back to what Michael said is we see a very strong momentum in all our businesses. We see a lot of positive momentum on the CAVI side, but we also, with the company program coming to fruition and some annualization effects in 26, there should also be some positive effects 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 the leveraging will remain core, but at the same time, we balance that with deliberate investments. And, you know, maybe even Q4, if I look at the momentum we currently see and where we are on the Carby side year to date, maybe we may take some decisions to, you know, do some incremental investments also in Q4, because in the end, It's about fueling our pipeline with StepUp and R&D, with StepUp and CapEx, and with StepUp and other investments. And we are prepared to do that.

Yes, and then, Graham, I can make it short so that the others have time. You know, the 40 may be a bit too high-fetched. I mean, already going from Q2, as I said, which was the 40, there will be incremental sequential growth, but 40 may be too high. Perfect. Thanks a lot, guys. Really appreciate it.

The next question comes from Falco Friedrichs from Deutsche Bank. Please go ahead.

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

Yeah, well, we can make that one 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 Sarah 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 Q4, which we took a deliberate decision to take it into Q4 and rather give the capacity to commercial batches. That is in essence by QC in Q3.

Thank you.

The next question comes from David Edlington from JP Morgan. Please go ahead.

Great. Thank you. Maybe related to the last question really. The year-to-date margin for CARB is 16.6 and yet you kept the 16 to 16.5% full year range. You've pulled out some needs for investment, potentially, I'm guessing, on the R&D side in Carby. Is that why you haven't increased the range for the full year and maybe just some help around how we should be modelling that quarter margin?

Thanks. So I think... if you look at where we stand today, I think how we had a very strong performance in terms of, in terms of margin, but you know, it's the underlying momentum we were seeing, which is strong. Now, if you look at Q4, as Michael said, there is a, it's 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, And then as the business turns to year end, obviously, there are, you know, topics whether we post the batch end of December or beginning of January doesn't really change the underlying momentum or the success of the business. And of course, around year end, you have customers wanting something from us, not wanting something. You have suppliers wanting something from us or not wanting something from us. You have final settlements, final invoices, and so on. So it's just a quarter which, you know, 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 Sarah left it. You know, look at the business, Look at the underlying momentum, which is in each and every individual business. This is a strong momentum which is going to carry also in 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 folks in Paris tomorrow.