Fresenius Medical Care AG & Co. KGaA (FMS) Q3 2024 Earnings Report, Transcript and Summary

Ladies and gentlemen, welcome to the report of the Third Quarter 2024 of Fresenius Medical Care Conference Call. I'm Sandra, the Chorus Call operator. I’d like to remind you that all participants will be in listen-only mode and the conference is being recorded. A replay will be available on the company's website. The presentation will be followed by a Q&A session. [Operator Instructions] The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Dominik Heger, Head of Investor Relations. Please go ahead.

Thank you, Sandra. I would like to welcome everyone to our earnings call for the third quarter of 2024. Thank you for joining us today. I'll start by mentioning our cautionary language that is in our safe harbor statement, as well as in our presentation and in all the materials that we have distributed earlier today. For further details concerning risks and uncertainties, please refer to these documents as well as to our SEC filings. The call is scheduled for 60 minutes. We have prepared a presentation and we'll have time for your questions after the prepared remarks. We would like to limit the number of questions to two in order to give everyone the chance to ask a question. Let me now welcome Helen Giza, CEO and Chair of the Management Board; and Martin Fischer, CFO of Fresenius Medical Care. Following the prepared remarks, we are happy to take your questions. Helen, the floor is yours.

Thank you, Dominik, and welcome, everybody. Thank you for joining our presentation today and for your continued interest in Fresenius Medical Care, which we appreciate even more given the attention to the U.S. elections today. Before I start with details on the quarter, it's important for me to say a few words upfront. I'm continuously inspired by the dedication of our employees around the world who go above and beyond to ensure our patients receive the life-sustaining dialysis treatments they need and with the highest level of care, irrespective on how much effort, challenge and difficult the environment around them is. We see what continued in the Ukraine and Russia, and more broadly in the Middle East and other crisis areas. Also, the U.S. faced some severe weather events, including Hurricane Beryl in Texas in July and Hurricanes Helene and Milton, impacting the Southeastern United States this fall. In anticipation of these hurricanes, we mobilized command centers a week in advance to begin the coordination with our local teams, doctors, hospitals and local authorities. We worked closely with patients to find alternative appointment times where patients could receive life-sustaining dialysis treatments before and immediately after the storms. Thanks to the tremendous response by our team, we were able to get our patients the treatment they require. Many thanks to the teams around the world who did an outstanding job in all these situations. I'll now begin my prepared remarks on Slide 4. The third quarter marked another period where our clear focus on improving operational performance and continued momentum in our company transformation directly resulted in strong improvement in our financial performance and meaningful progress towards our 2025 group margin target. Across both of our operating segments, we are realizing important progress as well as demonstrating our industry-leading capabilities. Beginning with Care Delivery, in the third quarter, we reached an important and reassuring milestone as underlying same market treatment growth in the U.S. turn positive. While the volume development is positive, it remains muted in the U.S. due to still elevated mortality. We continue to work on the volume pieces that are in our control, such as streamlining the admissions process and reducing missed treatments. As a result of these efforts, in the third quarter, we recorded improvement in cancellation rates and lower missed treatments. In our international business, we saw same market treatment growth accelerate to 3%, demonstrating that underlying trends for our industry worldwide remain intact. We like how the future of our international portfolio shapes up following the significant progress we made on our portfolio optimization. And as a result, we are more focused on growth markets with attractive returns. As already mentioned, thanks to the excellent hurricane disaster response by our teams, we were able to provide our patients their treatments and minimize miss treatments. In the third quarter, hurricanes and weather-related events only had a negative impact of 5 basis points on treatment volumes due to our strong disaster preparedness and quick response. I'm proud to say that our continued focus on quality of care as part of our day-to-day clinic operations has not wavered either. Fresenius Medical Care dialysis centers in the U.S. routinely rank amongst the safest and highest-quality dialysis centers in the country as measured by the CMS 5-Star Quality Rating System. In the just recently published rating for 2023, 65% of our dialysis centers in the U.S. received a weighting of 3-stars or higher. This was higher than the nationwide averages, which found fewer than 60% of all dialysis centers received similar 3-star or higher ratings. Earlier in October, it was reported that InterWell, our value-based care business achieved best-in-class quality performance in the first year of the U.S. government CKCC program. InterWell operated 10 of the top 10 and 17 of the top 20 highest scoring kidney contracting entities based on results recently published by the Center for Medicare and Medicaid Innovation. These results are a testament to the incredible partnership with our physician partners and our leading efforts to deliver value-based care initiatives and opportunities to the market. We believe this further strengthens InterWell's position as a partner of choice for nephrologists, payers and patients in the future. While these results demonstrate our industry-leading efforts to deliver value-based care, we must also acknowledge that value-based care is still a relatively nascent industry with lumpy and at times volatile financial returns. CMS also announced the final ESRD PPS reimbursement increase for 2025 just last Friday. While the 2.7% increase is slightly better than the draft rule, it is still below what we would have liked to see given the inflationary pressures on our industry. It is in line with our moderate assumption for reimbursement increases in our 2025 margin outlook. Our Care Enablement business has continued to achieve improving returns through the third quarter and has maintained the significant margin progress realized in the first six months. Solid volume growth as well as continued execution of targeted pricing initiatives and significant contributions from our FME25 program supported the strong performance. As expected, we did experience a greater negative price impact in China related to the implementation of volume-based procurement. This developed in line with our assumptions, and China remains an important and attractive market for our product business. Beyond our pricing initiatives, the continued optimization of our supply chain and manufacturing footprint remains a critical focus of our FME25 program. At the same time, we are focused on the future, ensuring we are strategically positioned to leverage our industry-leading capabilities and maximizing opportunities. We are fully on track with our preparations for the launch of our HDF enabled 5008X machine in the United States at the end of next year with full commercial launch in 2026, and we have seen strong interest at the American Society of Nephrology Congress at the end of October. While the 5008X will not need IV solutions for operations, we are also today benefiting from our vertically integrated business model. Thanks to our Care Enablement team stepping up after the hurricanes impact, on one of our competitors' production site, we had no interruptions in supply due to access to our own IV solution and PD products for our patients. As a consequence, we were not only able to accept more new PD patients at the end of the quarter in Care Delivery, but additionally, we were able to help other dialysis providers with access to products from our production. Moving to Slide 5. Turning to our specific third quarter developments. We delivered organic revenue growth of 2%, with positive contributions from both Care Delivery and Care Enablement. As mentioned, our underlying U.S. same market treatment growth turned positive in the quarter with 0.2% growth when adjusted for the exit of acute contracts. This also includes a 5 basis point negative impact from the hurricanes. Both segments realized both increased operating income and increased operating income margins. Care Delivery extended well into its target band for 2025 and Care Enablement improved its margin significantly year-over-year. This was supported by strong contributions from the execution of our FME25 program. FME25 contributed EUR64 million in additional savings resulting in EUR173 million by the end of the third quarter. We are well ahead of the targeted EUR100 million to EUR150 million for 2024. And with this acceleration, we now expect to achieve already in 2024 around EUR200 million. This confirms how well we are on track to achieve our target of EUR650 million in sustainable savings by the end of 2025. In line with our disciplined financial policy, we further reduced our net financial debt and improved our net leverage ratio to below our target corridor, which Martin will speak about later. Given our year-to-date performance through the third quarter and development against our assumptions to date, we confirm our revenue growth outlook and heighten our previous operating income outlook towards the upper end of our range with 16% to 18% growth for full year 2024. I'll now hand you over to Martin to take you through the third quarter financial performance in more detail.

Thank you, Helen, and welcome to everyone on the call. I will recap our third quarter financials beginning on Slide 7. In the third quarter, we achieved organic revenue growth of 2%, supported by both Care Delivery and Care Enablement. On an outlook base, revenue decreased by 0.7%, and our revenue development was negatively affected by divestitures, resulting from the successful execution of our portfolio optimization plan. The divestitures realized through the third quarter negatively impacted growth by 230 basis points. As you might recall, we decided not to adjust our numbers in the current financial year for the divestitures we are closing this year. We absorbed this impact in our guidance range for the year. Moving to operating income. On an outlook base, we saw an increase by 10%, driven by the improved performance of both segments. This resulted in a meaningful higher margin of 9.8%. With that, we are approaching our 2025 target margin band of 10% to 14%. Divestitures realized so far had a neutral effect on operating income margin. Special items during the quarter largely offset each other. Moving to Slide 8. This slide provides an overview of the 90 basis points group margin improvement. On the left, you see how we get from the reported third quarter 2023 operating income to the starting point of our outlook base by adjusting for special items and 2023 divestitures. In the middle, the chart shows the quarterly contribution by segment, including, intersegment eliminations and corporate. Both operating segments contributed positively. The impact on the progress we made in our Care Enablement transformation efforts stands out in particular. Last quarter, we explained that we entered into virtual power purchase agreement for renewable energy, so-called vPPAs. This is an important step towards our goal of becoming carbon neutral in our operations by 2040. vPPAs do introduce a degree of volatility to the earnings development due to the required quarterly evaluation of the embedded derivatives that then flows through the P&L. While vPPAs had a small positive earnings impact in the second quarter of EUR6 million, in the third quarter, vPPAs had a negative impact of EUR24 million on our corporate line. On the right, special items for the quarter included negative onetime costs associated with the FME25 program, which were partially offset by positive onetime effects from the Humacyte remeasurement and legacy portfolio optimization. Turning to Slide 9. In Care Delivery, the 2% revenue decline in the third quarter specifically reflected a negative 330 basis points impact from divestitures closed this year. Our underlying Care Delivery business contributed positive organic revenue growth in the third quarter. In the U.S., revenue increased by 1% on an outlook base driven by growth in our value-based care business, an overall increase in underlying treatment volumes and improved reimbursement rates and payer mix. This was partially offset by implicit price concessions. Thanks to a strengthened Care Delivery international portfolio, our international business contributed a very solid 4% organic growth supported by accelerated same-market treatment growth of 2.9% and higher reimbursement rates. Shifting now to operating income. In the third quarter, Care Delivery recorded an increase of 5% and a 70 basis point margin improvement, resulting in a margin of 11.2%. This is well within our 2025 target margin band. Positive business growth development was driven by price and volume effects as well as the phasing of a consent agreement on certain pharmaceuticals. While the phasing varies within a year, on a full year basis, we expect this to be broadly neutral. Business growth development was partially offset by negative contributions from the value-based care business. While value-based care is a positive contributor in the first half, unfavorable financial developments within the CKCC program had an adverse impact on business growth of around EUR40 million in the quarter. As mentioned in the past, there is some earnings volatility of this business and nine months in, we now assume a negative contribution of value-based care to operating income of EUR20 million to EUR40 million for the year. FME25 savings were a relatively smaller contributor for Care Delivery as the majority of the programs initiative is focused on global G&A functions and our Care Enablement segment. Finally, the labor headwind in the third quarter was driven by higher personnel expenses, which were in line with our expectations. Next on Slide 10. In the third quarter, Care Enablement realized 4% organic revenue growth. This was primarily driven by solid volume development across all geographical regions. Continued pricing momentum outside China added to this positive development. As expected, the extended rollout of volume-based procurement in China negatively impacted the pricing development. This was in line with our expectations and is factored into our outlook for the full year. Turning to operating income now. Care Enablement achieved a significant increase, nearly quadrupling from the prior year quarter three. Accelerated savings from FME25 were the biggest contributor of operating income growth. A solid contribution from business growth was driven by positive volume and pricing development. This was partially offset by negative pricing effects related to volume-based procurement in China and impact from foreign currency transaction. Inflationary cost increases developed in line with our expectations. Care Enablement already achieved significant margin progress in the first half of the year, and it is positive to see the business maintaining its momentum through the third quarter, while absorbing the negative effects from volume-based procurement. The strong brokers today puts us well on track to achieve our 2025 margin targets. Moving to Slide 11. In the third quarter, operating cash flow increased mainly due to the recovery of the cash impact following the cyber incident at Change Healthcare. With this strong quarter, we have partially caught up on the delayed collections in the first nine months. For the first nine months, the decrease in free cash flow was additionally affected by the phasing of dividend payments received from equity method investments as well as income tax payments for current and prior year periods, particularly in the U.S. Both our total debt and lease liabilities as well as total debt and lease liabilities and net debt and lease liabilities have further decreased compared to the prior year third quarter. And as a result of our commitment to a disciplined financial policy and positive EBITDA development, our net leverage ratio improved to 2.8 times. This is a great achievement, and it is below our self-imposed target corridor of 3 times to 3.5 times net debt-to-EBITDA. Our priorities have not changed. In line with our current strategic ambitions through 2025, deleveraging remains our top capital allocation priority. As we continue to execute our portfolio optimization plan, we will use the proceeds to further reduce debt and strengthen our balance sheet. We want to ensure that our company is in good financial health as we start to prepare for our future strategy. With that, I hand over to Helen.

Thank you, Martin. I'll pick it back up on Slide 13 with an update on our outlook. Overall, and despite some headwinds like vPPAs and lower contributions from value-based care, we are well on track to deliver against our positive outlook for this year. We expect to realize further improvements in our operational performance and transformation efforts in the fourth quarter. Therefore, we confirm our revenue outlook for full year 2024 and heighten our expected operating income growth towards the upper end with 16% to 18%. When we compare our assumptions, which we initially shared back in February against the development after nine months, we are broadly in line with our expectations in phasing. The biggest deviations from our initial assumptions were the successful acceleration of our FME25 savings program, which compensated for the more muted U.S. volume growth, negative contribution from our value-based care business as well as the impact from vPPAs. Just as a reminder that in last year's Q4, we entered into a favorable settlement agreement with the U.S. government. The Tricare settlement positively impacted Q4 revenue by EUR191 million and Q4 operating income by EUR181 million and was not reported as a special item. We excluded this effect from the 2024 outlook base. We are also confirming our 2025 margin outlook of 10% to 14% group margin. The quarter once again demonstrated that we are on track with our turnaround and that we deliver on what we said. Both Care Delivery and Care Enablement are meaningfully progressing towards the 2025 target margin bands. Our transformation momentum continues positively. For 2025, we are still unpacking the full impact of the new rules of binders moving into the bundle. We still have elevated mortality and a flu season ahead of us as well as some other moving parts like vPPAs, value-based care volatility and the volume increase from volume-based procurement in China, just to name a few of the moving parts. Therefore, we have decided that we do not tighten our 2025 target range today. As every year, in February, we will share the detailed outlook and the corresponding assumptions for 2025. Meanwhile, rest assured that my ambitions for 2025 remain rock solid, deliver as promised. And finally, as we approach the end of 2024 and everyone starts arranging their calendars for next year, I do want to highlight that we plan to host our next Capital Markets Day on June 17 in London. We hope many of you will be able to attend. So please save the date and look out for future communications from Investor Relations in the coming weeks. This concludes my prepared remarks. I'll now hand it back to Dominik to start the Q&A.

Thank you, Helen and Martin, for your presentation. Before I hand over for the Q&A, I would like to remind everyone to limit your questions to two. If we have remaining time, we can go another round. With that, I hand it over to Sandra to open the Q&A, please.

We will now begin the question-and-answer session. [Operator Instructions]

Thank you. And the first caller is Richard Felton from Goldman Sachs.

Thank you very much. Thanks for taking my questions. My first one is on the medium-term margin guidance, please. So obviously, still quite a wide range heading into 2025. Should we assume that the decision not to narrow the range at this stage does indicate you still see a path to getting into the upper half of that 10% to 14%? That's question one. Question two, also on the topic of margin and specifically on the Care Enablement business. This year, making very good progress improving profitability, but I suppose, still quite a big gap up to the lower end of the 2025 target. Could you remind us of some of the levers you've got to keep up the momentum on margin progression for that part of the business? Thank you.

Thanks, Richard. I think I'll tackle both of those. On the medium-term margin, as you can appreciate and what I tried to provide color on, there's still a lot of moving parts. And as we've seen this year, every quarter informs us, I think, particularly on the volume and mortality, we are currently in -- probably next deep into our budget discussions for next year already. So we feel with a few more data points, we'll be able to guide that accordingly and we will do so in February. Obviously, we recognize there are still wide ranges out there, but we want to be able to provide the right color in February with a few more data points. On your second question on margin for CE, we're thrilled with the progress we are making there. And as you can see, meaningful development over the course of this year. We've always said that CE would be back-end loaded because of the kind of the size and scale of many of the FME25 programs particularly around manufacturing footprint and so on. So again, we have a range out there as we get more color on that in February, we'll be able to kind of advise that, that range accordingly. But again, you can expect that to be back-end loaded. And as we're still standing behind those margin targets, I think you can expect us to see continuous progress on that through 2025.

Thank you, Helen.

The next question comes from Victoria Lambert from Berenberg. Victoria, line is yours.

Thanks for taking my question and thanks for providing the like-for-like impact from the hurricanes in Q3. You said it was about 5 basis points. What is the expected impact from hurricanes in Q4 just given the timing of Hurricane Milton? And then just on the Care Enablement margins, what benefit can we expect in Q4 from FMC being able to step in and supply the PD machines? And will this benefit next year as well? Thank you.

Thanks, Victoria. I think I'll take those two. On the hurricane, we're still kind of quantifying what the impact is on the hurricanes for Q4 that we could expect it to be similar, maybe slightly lower level. Obviously, we were impacted but back up and running pretty quickly, but we'll provide more color on that when we get to full year. And then on the CE benefit, obviously, we are seeing increased demand from the CE product side for PD products where obviously, I'm packing some of that in real time. I don't have anything I can speak to today in terms of sizing but I think we'll take that into account when we do the kind of the business development growth numbers for 2025 and we'll be able to scale it accordingly once we have a little bit more dissolidified. But obviously, happy to help out and kind of work through the increased demand from PD and on the CE projects business.

Okay. Good. Next question comes from Robert Davies from Morgan Stanley. Robert?

Yes. Thanks for taking my question. My first one was just around the issue of, I guess, the growth progression, the same market treatment growth. And just if you could provide any color in terms of what you're seeing on the excess mortality side, it has obviously been a big sort of discussion topic over the year. Just be curious of what your view of where we sort of stand on that and how that would impact the sort of outlook over the next sort of three to six months. The other one was just where we are in terms of sort of clinic closures? Anything additional since the last quarter that you've identified for potential clinic closures that wasn't in the original plan or anything left to go? Thank you.

Thanks, Robert. On your same market treatment growth, obviously, we're still talking about small numbers here. We did see the underlying progression in the quarter Obviously, though, as you can appreciate, September was hit by the hurricane impact. So small numbers on small numbers. On the excess mortality, we still see that elevated. And I think that's the number that we are obviously closely watching in terms of our kind of -- we're all saying that we expect the growth to return back to normal levels once the excess mortality numbers kind of stabilize. So again, I think that's why we're watching this every month and every quarter to be able to provide color on our growth expectations for next year. On your clinic closures, it's kind of a little bit of a complex answer because where we have growth opportunities in certain parts of the country. we are kind of investing in opening new centers. So I think net-net, we opened 11 centers this year, but that's only where we were at full capacity. And where we have underutilized capacity or clinics that are not performing, we are looking on a case-by-case basis if there's more to close. I don't expect that to be a big, big program, but every quarter, we are looking at those clinics and kind of teeing up handfuls of clinics to close, where that makes sense. But I think we're being very selective in where we invest, but also where we close as well.

Maybe just one quick follow-up. Just in terms of where you are in terms of those new clinic openings in terms of getting staffing and headcount because obviously, labor inflation was a bigger issue maybe a year ago. Are you having any issues in terms of getting new dialysis nurses into the clinics in terms of cost or difficulty in finding them? Thank you.

Yes. Thank you. Taking your third question. In terms of open positions, we actually came down in the quarter from 3,500 to 3,300. The mix of nurses and PCTs has stayed pretty stable. So we're filling more nurse positions, which is great than PCTs. So I'd say labor is pretty stable. I mean clearly, we're still through some hotspots in terms of where we do have some constrained clinics and trying to do what we need to with staffing, but that number has come down significantly over the course of the year. So overall, managing labor quite well, I would say.

Thank you very much.

Thank you, Robert. And the next question comes from Hugo Solvet from Exane BNP. Hugo, the line is yours.

Thanks, Dominik. Hi, guys. Thanks for taking my questions. I have a couple. First, thank you, Helen, for the details on the volume progression during the quarter. Just a quick clarification. I think in previous calls, you mentioned that we potentially expect an exit rate in FY 2024 of about 2% to 3%. Do you still think that this could be possible? And lastly, I'm sorry if I missed that, Martin, in your comments. Can you maybe quantify the impact of the consent agreement on pharmaceuticals in the quarter? That would be helpful. Thank you very much.

Thanks, Hugo. I'll take your first question, and Martin can take your second. We stay confident in the underlying fundamentals of the industry that when we see the normalization of mortality and the normalization of the funnel that we do expect to return to that kind of 2% to 3% pre-COVID growth rate. Obviously, as we see, we are across the industry still seeing elevated mortality I think the timing of that is something that we are kind of obviously watching. But there's nothing to say that once that normalizes, we don't return. We had always said that, that was an exit way for 2025. So more of a kind of a normalization rate for 2026. And I think that's why, obviously, as I talk about guidance and tightening those ranges for '25, kind of really thinking through what do those volume trends continue to progress through the next few months and quarters here. But the improvement in mortality, obviously, is something that we are looking for as well as the normalization of the CKD funnel.

Yes. And Hugo, perhaps on the margin development for Care Delivery in quarter three. Main drivers were positive price and volume effects. And then we saw the phasing of the consent agreement that you mentioned. This was this year in quarter three. Last year, we had that in quarter four. So that is, from our perspective, over the full year, more or less neutral. And when you look in quarter three, you had then the consent agreement positivity. Also, as outlined in the presentation, partially offset by the volume-based care topic.

Thank you very much.

Thank you. The next question comes from Oliver Metzger from ODDO BHF Bank. Oliver, the line is yours.

Yes. Thank you. Good afternoon. First question is on your updated EBIT guidance. So I like the narrowing, but it is still a big range given there's just 1 quarter to go. So how do you think about it? Is it more the mid -- you look for the midpoint and you've added 1 percentage point to each site as a safety margin? Or have you worked on the updated guidance with different scenarios for the lower and upper end? The second question is on FME25. It's good to see that your saving progress is ahead of expectations. So is it, on the one hand, a kind of pull-forward effect? Or do you see some additional savings which might be -- and Martin, I remember you commented in the past that you won't expand FME25, but do you still see some additional saving potential, which might come on top for 2025. Thank you.

Thanks, Oliver. Yes, let me take those questions. On EBIT guidance, it is clearly, as we do every quarter, a bottoms up build of what we see through the year-to-date and what we expect for, as you say, just a couple of months left in this quarter. It is not just taking the midpoint. We do have sensitivities of one thing going one way, positive or negative. So overall, clearly, that's why we have a range, and we're watching things that could go as headwinds or tailwinds. So we've narrowed it. We feel confident in what we need to deliver, but obviously, that 1% either way, it's not just a -- let's take the piece in the middle. On FME25, I'm thrilled with the progress we're making here. And clearly, the acceleration and the momentum is good to see. We're not thinking of that, as you rightly said, of expanding the FME25 program. We're still committed to delivering that EUR650 million. Some of these are initiatives that are delivering earlier than we had first thought. So that's great. As I've shared with many of you while we've been on the road, increasingly, as we think about the culture shift and strategically how we run the business, we are thinking more about kind of not a new concept, but the concept of continuous improvement where we are looking to drive efficiencies to offset kind of the inflationary headwinds that we see. So outside of FME25, clearly, we're still working on the turnaround and driving efficiency improvements. And I think that shouldn't need big programs like we've gone through the past few years in the future, but just more this mindset of trying to drive that continuous improvement. And obviously, when we give the guidance for 2025, we can provide more color to that kind of in February.

Okay. Thank you. Very, very quick follow-up on this. So do you see from now a higher saving potential by 2025 compared to the FME25 saving aspiration?

No, we're still saying we save EUR650 million for FME25 through 2025.

Okay. Thank you very much.

Thank you, Oliver. The next question comes from Sezgi Oezener from HSBC. Sezgi, the line is yours.

Hi. Thanks for taking my question. I will also have two, please. One, very [indiscernible] one maybe, but the other income that you have in this quarter seems quite strong. What are the underlying factors from that? And the second one is on this consent agreement on the pharma side that you've mentioned. What's the outlook going forward? What are some of the deciding factors behind it? And yes, what's the impact you're estimating, if any, beyond 2024.

So thank you, Sezgi. Let me start with the other operating income one. So there is a couple of effects that we see in the year-over-year improvement here. On the one hand side, you have the special items like Humacyte remeasurement and the legacy portfolio optimization positively impacting this. And then you have FX exchange topics in here as well and also the consent agreement on the pharmaceuticals that we mentioned in the CD business is showing up in that line as well. So that should give you a bit of a flavor of the underlying driving factor. And then on the consent agreement itself, this is a topic that we normally have throughout the year. As I mentioned before, it is a phasing topic, which is why it shows up in quarter three this time. Last year, it was in quarter four. And on a full fiscal year basis, we see this broadly neutral, and it is not an underlying driver of our improvement. I hope this helps and answers.

Thanks very much.

Thank you. The next question comes from Giang Nguyen from Citi.

Hi, guys. Thanks for taking my questions. My first question is back on the U.S. volume growth. Could you quantify the headwind from elevated mortality in the quarter, please? And also, given your progress on new patients, does it make you more confident now? Just looking at the trends from here, do you expect this progression to continue in sort of the next quarter so Q4 and Q1 next year? And then on top of that, how are you feeling about your relative momentum versus peer this quarter?

Thanks, Giang. I think I may have you repeat the third part of that question. But let me start by talking about the U.S. volume growth and the elevated mortality. We had called out in half one that we had seen about 60 basis points of increased mortality impact from flu and COVID, and we're still seeing the overall mortality number higher than what we had seen pre-COVID. So for the quarter and the rest of the year, we're assuming similar levels. Obviously, what that looks like for 2025, we still need to shape that once we see the numbers coming in for Q4 when we give guidance in February. And obviously, when we get to February, we will quantify it accordingly. I think the other piece, and I mentioned this in my talk outline, was the kind of the flu season and seeing if we get some insight into how that flu season for 2025 is translating. Obviously, it was a later flu season this year. In terms of new patients, our improvement, I'd say, is -- while we're excited to see the positive volume, there is a piece there that is kind of new patient -- net new patient inflow, and obviously, a piece that's due to the work that we are doing on improving a lot of our processes. So overall kind of treatment volumes coming up. And I think the last part of your question was about momentum compared to the competition. I think we're all talking about improvements in small numbers. And I think we see -- we're all seeing the market quite similar. But obviously, pleased with our operational performance and progression this quarter, particularly. And I think that just shows that the work that we are doing and what we are doing in rebuilding and turning around our Care Delivery U.S. business is paying off. And I think it's a great inflection point for us.

Thank you. And I just have a quick follow-up question, if I may. And this is to do with a different topic, which is the PD business in the U.S. Can this opportunity or this hurricane situation change in any way your structural thinking around this PD business? And when you said you would be able to help other providers, is it based on some sort of a long-term -- new long-term contract? Or is it on a more ad-hoc basis? Thank you.

Obviously, we have been quite vocal over the last couple of years that our PD business in the U.S. is a loss-making business, and we are doing a lot of work on that to turn that profitability around. And some of that is part of the CE FME25 program. Obviously, for PD, we supply ourselves, and we already have contracts where other dialysis providers. So I think to the extent that we have more patients that we can serve on PD that benefits our Care Delivery business as well as our Care Enablement business, and to the extent that we are entering into extended contracts on new contracts with other providers, obviously, that benefits the Care Enablement products business. So that work is continuing, and we are kind of -- as I mentioned, we will give color on that and how we see the volume progression for Care Enablement when we give the outlook for 2025.

Thank you.

Thank you. The next question comes from David Adlington from JPMorgan. David, the line is yours.

Thanks, everybody. So maybe just it would be great to get your thoughts on the inclusion of the oral drugs in the bundle next year, and how much of a tailwind that might bring you, but also your thoughts in terms of whether it actually gets them active? And maybe just any update you got in terms of the timing of the pharma companies' appeal against that? Thank you.

Hi, David, happy to take that question. Obviously, we're still unpacking the language in the ruling. It's still not final, but that came out on Friday, which obviously starts to give color into what that reimbursement for it will be. We're thinking -- I think -- we're not just -- the orals in the bundle obviously don't just impact our FKC clinic business. It also impacts pharma and pharmacy business. So we -- say we're unpacking that in real time. We are, right now, we're thinking that it's neutral to positive. We'll frame that again in -- when we get to guidance and we get a final rule in February. But yes, a lot to work through there. In terms of your question on what pharma companies are doing and what maybe our industry is doing, I think there's still a fair amount of discussion in D.C. regardless of whether it goes into the bundle or stays out of the bundle, I think where we have to be prepared regardless for either option, come January 1 because if something does change, one way or the other, we're unlikely to know until kind of probably the lame-duck season in February -- sorry, December, December. Maybe I'm thinking that we will be -- have an election announcement by February. So yes, I think, look, the rule it's still in draft form, and we'll figure out what that means for us as well as the absolute timing on the ruling.

Perfect. And then maybe just a quick follow-up. You obviously wanted to start this year expecting to narrow the guidance for next year, the 10% to 14% guidance as it went for the year and you've now pushed that back out to February. Do you think your visibility has reduced as the year is going on? Or has it maintained the kind of a steady trajectory? And if most of that visibility is just down to the lack of volume growth?

Great question. I think we've got pretty detailed bridges of how we saw the moving parts of the margin band, both for Care Delivery and Care Enablement. I would say, the transparency that we now have a new operating model is terrific and actually gives us more insight into the moving parts, that I think we can -- we have a better degree of forecasting them than we ever have. So -- but as you can appreciate, there's many, many moving parts, volume being one of them. So as I mentioned in the -- I wasn't trying to just throw the laundry list out there of all the things we're balancing, but there truly is a laundry list of all the things that we're balancing, whether it be volume growth, value-based care, value-based procurement, binders in the bundle, reimbursement, all of these things, plus positives and negatives, we are weighing up in real time. And I think it can easily be the difference between the one end or the middle of a range. So we just don't want to tighten something or give something prematurely as there's still many, many moving parts. And as you said at the beginning of the year, I'd love to have been in a situation where there weren't some -- many moving parts to watch, but clearly, the volume piece of this and our own turnaround and transformation efforts weigh into all of that. So I appreciate you all bearing with me. I'd rather -- as you all know, I'd rather be giving something that is definitive where we have as much data in real time, considering all the different moving pieces that we're dealing with.

That’s great. Thank you.

Thank you, David. The next question comes from Marianne from Bank of America. Marianne, the floor is yours.

Thank you for taking my question, and good afternoon. I just have one quick one. On your leverage ratio now that you have reached below your target range. Just wondering if you had any idea on how you think about capital allocation going forward? Anything special that has come up in your discussions?

Yes. Martin, do want to take that?

Yes. Happy to take that. So first of all, we are very happy that we reduced our leverage ratio by 0.4 points and 0.3 comes from debt reduction, 0.1 comes from EBITDA improvement. And we will continue to deploy our capital to further reduce debt in line with our priorities that we set. And as I outlined in the prepared remarks, we are strengthening our balance sheet on purpose. And until 2025, that's our core focus.

Yes. And Marianne, maybe I would just add to Martin's comments. We clearly want to align our new capital allocation priorities to our new strategy. I don't want to be changing that around or kind of anybody speculating on what that means until we have done kind of a clear articulation of our strategy in post-2025, and the capital allocation will be aligned with that, and that's what we'll get to share when we do the Capital Markets Day on June 17. My plug for Dominik there.

Very clear. Thank you very much.

Thank you, Marianne. The next question comes from Falko Friedrichs from Deutsche Bank. Falko, the line is yours.

Thank you. I have two questions, please. Firstly, outside of COVID and the flu, are there any other reasons that explain the sticky excess mortality that just doesn't really want to come down? And then secondly, and I'm sorry if I missed that point. Is it fair to assume that the same-store treatment growth should improve further in the fourth quarter over the third quarter? And are trends in October, have they been supportive of that? Thank you.

Yes. Thanks, Falko. Yes, look, on the mortality, I don't think there's anything further to kind of -- that we can explain on that outside the -- it remains elevated in the current patient population and the flu and COVID numbers. But obviously, the other piece of this, and we've continued to say, we don't -- we truly don't believe it's the impact from new drugs because those numbers are pretty small and the fallout rate is high, but its normalization of the CKD funnel, which obviously impacts the inflow of patients. So I think that's something, obviously, that we are continuing to work through and watch. On the Q4 trend for same market treatment growth, as I mentioned, in Q3, every month, we saw a small sequential improvement. Obviously, it's dampened by the hurricane number. And as you can imagine, when you got 20 basis points of growth and 5 basis points is hurricane, you can see the impact that, that has on any given month. But we are expecting that underlying positive trend to continue through Q4 and consistent with the range we've given of 0 to 0.5% of volume for the full year. So we're kind of encouraged by the underlying progression there, recognizing they're still small numbers.

Okay. Thank you.

Good. The next question comes from Sezgi Oezener from HSBC. Welcome back. Sezgi?

Oh, sorry. Thanks for taking the question as well. I just wanted to ask about why you have decided not to adjust your 2024 base for the divestments going forward? Is it because they're coming towards an end? Or is there a different reason that makes it different from 2023 position?

Martin, do you want to take that?

Yes, I'll take, that's okay. So when we outlined our portfolio optimization plan, we were very specific about the scope of those. And hence, since we shared that transparency, we also said we will build the effects of the ones as we plan them into our guidance and absorb them. And therefore, every quarter, when we are calling out the effect from divestiture with the 330 basis points you saw this time for the Care Delivery, this is how we are progressing. And we are pushing to also complete that list and are executing well and are well on track to do so. And for 2025, we have not adjusted -- we have not decided yet how we're going to adjust that. It also depends on the timing of the final executions of the closing on a couple of transactions.

Thanks very much.

Thank you. The last caller is Christian Ehmann from Warburg Research. Christian, the floor is yours.

Thank you for taking my question. I have just one. Considering that we are now at plus 3% same market treatment growth, and you stated before that you expect those to return to 2% to 3% over the next years. What kind of factors play into this assumption? Thank you very much.

Yes. Hi, Christian. Obviously, we're moving from what is currently in this quarter, 0.2% to still our underlying expectation that this though the market does resume to pre-COVID levels. Obviously, the elevated mortality plays into that as well as the normalization of the CKD funnel. We obviously -- we recognize we have transplant numbers that are very consistent year-over-year that -- and the drug impact that we don't feel is having an impact either. So truthfully, it's the kind of reduction in mortality as well as the inflow of patients from the -- sorry, the inflow of patients from the CKD funnel. In terms of the international growth, we're very -- we're thrilled with what we're seeing there. I mean, obviously, that was a significant cleanup of the portfolio where we had exited a lot of countries over the past two years here. So there, we're seeing 2.9% same market treatment growth. We do see in Europe and other parts of the world that the mortality has come back down to pre-COVID levels. That's also what gives us the confidence that the U.S. mortality should come back down. It's clearly just taking longer. But I think on the international side, it's a much more focused effort on countries that we see significant improvement in growth and operational performance, but the volume is looking really good there and thrilled with the performance of the CDI or the Care Delivery International team. So thank you.

Thank you very much.

Thank you. So we do not have any further questions, have three minutes left. So we'll not fill those. You're lucky. Thank you for joining and your interest and the many questions, highly appreciated, and we'll hope to see you or some of the listeners on the road in the next couple of weeks. Thank you. Take care.

Thanks, everybody. Have a good day.

Thank you. Take care.

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