Fresenius Medical Care AG (FME) Earnings Call Transcript & Summary

Ladies and gentlemen, thank you for standing by. I'm Natalie, your Chorus Call operator. Welcome and thank you for joining the Fresenius Medical Care Expert Call on Innovation in the Renal Care Continuum. [Operator Instructions]. I would now like to turn the conference over to Dominik Heger. Please go ahead.

Thank you, Natalie. We would like to welcome all of you to the Fresenius Medical Care Expert Call series 2021 in which we address 3 different topics over the course of this year. After our March event about mapping a digital future for kidney care, we present you today our second expert call about innovation in the renal care continuum. I do want to apologize that we had to move the call by 1 hour. Thank you very much for your flexibility. Therefore, we appreciate even more that you join us today. For those who are joining via telephone today, you can find the slide pack on our website under Investors, Events & Presentations, Meet the Management. As always, I'm somehow forced to start out the event by mentioning our cautionary language that is in our safe harbor statement on Slide 2 of the presentation. For further details concerning risks and uncertainties, please refer to this document as well as to our SEC filings. The purpose of our company is to create a future worth living for patients worldwide every day. Innovating for our patients is key in this respect. I'm thrilled that we could win Dr. Olaf Schermeier, our Chief Executive Officer for Global Research and Development, to give you some deeper insights today into how this area will further drive the future of kidney care. Please be aware that this call as well as the following Q&A session will not cover the financial background, related costs or revenue questions. Furthermore, I would like to ask for your understanding that we will only answer any questions related to R&D today. We will release Q3 earnings on the 2nd of November and then are outstandingly happy to discuss the operational business performance. We really like to focus in this 1 hour on the topic of innovation in the renal care continuum. And now I'm quiet and will hand over to Olaf. The floor is yours.

Thank you, Dominik. Good day and good afternoon, everyone, and a warm welcome also from my side. My name Olaf Schermeier. As mentioned, I'm Fresenius Medical Care CEO for Global Research and Development. I'm really pleased today to guide you through some of our exciting projects and activities in the area of innovation. So as mentioned by Dominik, innovating products and continuously improving therapies are really intrinsic elements of Fresenius Medical Care's vision. And as we are the world's only truly global and vertically integrated dialysis provider, so innovation is embedded as an integral part of our corporate strategy. So I assume that at least some of you will recall the strategy visual that we introduced at our Capital Markets Day in 2020. And this chart shows the 3 focus areas in which FMC intends to drive and grow its business in the medium term. These 3 areas, the renal care continuum, the critical care and the complementary assets, they will also serve as the basis for my presentation today. So talking about the renal care continuum. This includes all areas of our core dialysis business. Here, we are continuously enhancing our portfolio of products in order to provide patients with high-quality treatments in both the value as well as the premium segment. So we see enormous potential in leveraging our unique data assets across the entire renal care continuum to map a digital future for comprehensive kidney care. Our unique positioning allows us to establish new digital care models, both in in-center and also in-home dialysis. So our data analytics and predictive modeling skills make us the company of choice also in value-based care models. Talking about critical care. We have expanded our offering with the Xenios acquisition some time ago. And during the pandemic, we experienced high demand for our Novalung ECMO portfolio. And we have gained approval in multiple geographies, including the United States, and we expect significant growth. NxStage is our key asset to fulfill the promise of enhancing home care but also an important technology which further broadens our product offerings for patients in critical conditions. With NxStage, we are also providing our digital agenda, having therapy systems connected through our connectivity backbones. This is an important element of our advanced and unique digital ecosystem that is focusing on full device connectivity of all our systems. Talking about complementary assets. We are focusing on the quality of life of our patients. Here, we are also leveraging our core competencies to expand also beyond dialysis care. Fresenius Medical Care wants to be the leader of change in providing these new therapy options, and this will allow us to establish new market segments, business models and revenue streams. With that, I move to Slide #4. In order to be able to treat our patients in the best possible way, alongside the entire renal care continuum, it is key to understand their needs and the needs of our customers. Today, I want to guide you through a typical journey of a patient suffering from chronic renal disease. I want you to know we understand these challenges emerging in each of the different segments of the patient journey. I want to also give you insights on how we are addressing these challenges, needs and potential hurdles. Let's start with pre-ESRD segment. Typically, patients with chronic kidney disease have a history of disease when getting diagnosed. They suffer from comorbidities such as diabetes or cardiovascular disease. The issue is pre-ESRD stages are often undetected since CKD does not hurt so you don't recognize that. Therefore, CKD is often diagnosed far too late, which makes it hard to prevent or at least to slow down the disease, and therefore, an easy detection is really key when it comes to developing new tailored therapy approaches and services, and this underlines the importance of a comprehensive disease management. So we really need to break the silos by not just focusing on CKD and instead covering the mentioned comorbidities as well. Besides CKD, an acute kidney injury, of course, can also result in ESRD and the patient needing dialysis on a permanent basis. At this point, this should only be mentioned for the sake of completeness. I will talk about critical care later when we get to the critical care part of the presentation. Talking about home dialysis. This gives overall much more flexibility to the patient and how they live their lives despite their illness. They can dialyze during nights, and they do not need to be transported to a clinic several times a week. But even in home, that is a setting the quality of life of the ESRD patient can be limited. So it's really affordability of the home dialysis treatment and the patient compliance, these both present significant challenges. So you got to understand that dialysis therapy is much more complex than other treatments that found their way into the patient home so far. Older patients and their care partners at home sometimes fear of making mistakes. So as a consequence, that might lead -- such a mistake might lead to bleeding or infections such as peritonitis, which then again negatively impacts therapy outcomes. So it has to be really -- our goal is to tackle these challenges in order to further enhance the quality of life for these patients at home as long as possible. So the early detection of CKD also helps us here as it prevents patients from crashing into dialysis and instead allows enough time to educate patients on home dialysis. So when patients who suffer from certain or multiple comorbidities cannot be treated in a home environment and for them, it's really safer to get dialyzed in center. Here, again, the cost burden for health care systems is a key driver for innovation. We are mostly focusing on all elements of the value chain. This starts with the reduction of product cost but also the automation of manual work processes and work steps also through improved therapy outcomes then resulting in lower hospitalization rates. And with that, of course, it's -- personalized care, patient-centric therapies and also individual care management are key. Towards the right side of this patient journey, we see the transplantation. This, of course, would be the best and preferred option for most ESRD patients, allowing them basically to live their life almost normal. But we all know transplant waiting lists are getting longer and longer every day due to demographic change and an increasing number of ESRD patients. And unfortunately, getting a transplant does not necessarily promise therapy success. So in addition to the immune response of the patient and rejection, the lifestyle of the patient impacts the lifetime of the transplant. So we want to really tackle both the global organ shortage as well as the limited lifetime of the graft. Let us continue on Slide 5, please. So as mentioned, the majority of CKD patients are not aware of their disease. So an early detection is therefore key in order to provide tailored therapies and delay the progression of the disease. So with our Fresenius Medical Care venture, we are sourcing external innovation with strategic investments in early-stage companies. This approach is complementing our corporate activities in CKD and in dialysis, and I will further elaborate on this and some examples when we talk later about our complementary assets. In the middle part of the slide, you see our data solution. So patient data has become the fuel of our industry. With Fresenius Medical Care data solutions, we are leveraging our therapy and health data pools, and this helps us to provide a more individualized comorbidity management and treatment. So let me mention 2 examples here. By using AI for CKD progression and cardiovascular risk assessment, we can already today predict disease progression as a basis for individualized therapies. Another example, we are working on a CKD patient management program in order to slow down progression and to reduce complications as well as hospitalization. With Unicyte, we are following a more disruptive approach as regenerative medicine and stem cell therapies, and they have the potential to delay the progression of CKD 3B2-5 by restoring the kidney function. Unicyte is applying human liver stem cell-, so called HLSC, derived nano extracellular vesicles, so-called nano EVs or also micro vesicles, and they are used in chronic kidney disorders. So we have really strong preclinical data that indicates the efficacy of these nano EVs, preventing renal fibrosis. We expect the clinical trial application submission for the first-in-human study already next year. By expanding into earlier CKD stages and the area of regenerative medicine, we are following a complementary approach. So these new therapies will come with new business models and new revenue streams. Overall, we do see significant growth potential in renal care segments also beyond dialysis. And this will, however, not limit our expansion in our core business. And with that, I'd like to move to Slide #6. So out of the 3.6 million dialysis patients worldwide, an increasing number of patients undergo dialysis at home. We believe that there's significant potential to grow in this segment. However, this requires both easy-to-use but also affordable home therapy systems. And as mentioned, costs are not the only limiting factor here. We have to address the patient compliance and monitoring. Therefore, a connected home environment is key to grow in-home dialysis and to enable best-in-class therapies and an improved quality of life for the patient. The NxStage technology is a key strategic enabler for our home dialysis expansion when it comes to integrated water purification, the size of the device, patient centricity and ease of use of the system. And next to me is our digital solution for home hemodialysis. This complements our connectivity infrastructure and thereby further drives the implementation of our advanced and unique digital ecosystem. And this allows us again to apply predictive models and personalized patient management. In PD, I'm glad to inform you that just a few days ago, the 510(k) for our all-new PD cycler, [ VersiPD ] has been submitted and accepted for review by the U.S. FDA. You see it on the bottom left of the slide. And with some pride, I want to say that [ VersiPD ] is the smallest, the lightest, the quietest, the smallest pumping APD cycler in the world. It's extremely easy to learn, intuitive to use and digitally enabled to improve the patient experience. And talking about affordability now as a challenge. I would like to mention the launch of another new PD cycler. It's the SILENCIA PD cycler that you see in the middle of the page. With this reliable, super quiet and low-cost and easy-to-use APD cycler for developing countries, we make dialysis at home affordable also in these low-income countries and see major growth potential in this value segment of the market. We have already performed thousands of treatments with this new system and have seen excellent results. Only in a fully connected environment we will be able to realize the full potential of home dialysis. This is why we have established Kinexus. It's a home connectivity platform that includes all home treatment modalities and systems. Kinexus is a secure and cloud-based solution that connects patients and clinicians. Therefore, it provides the basis for applying analytics, AI and machine learning but also predictive models in order to create actionable insights for better patient care. And we have some more information around that on Slide #7. So by implementing the full device connectivity of all our systems, we believe we can transition to smart dialysis machines with data-based solutions, especially in the home dialysis setting. The combination of the various data pools provide new opportunities to improve the patient experience on the one hand, but also therapeutic outcomes. So Kinexus was just recently launched, and we have already scaled up permanent connectivity to more than 14,000 home patients by today. And with its most advanced cloud-based architecture, we have reached significant milestones in bidirectional connectivity, data security and privacy. To conclude the topic of connectivity, let me briefly outline how the innovations mentioned here lead to improve therapy outcomes and economics. So digital enablement allows us to personalize therapeutic options more quickly. In doing so, we can better manage the fluid status and other complications. We can prevent hospitalizations and allow patients to stay on home therapies longer. In addition to these cost savings and quality of life improvements, software as a service creates additional revenue potential, and in value-based care settings nephrologists will find value in the digital infrastructure and predictive analytics to services which prove both clinical efficacies and therapeutic outcomes. For example, models which can tell physicians when the best time to transition a patient from PD to home HD will enable a smooth transition. And using AI to better manage alarms and equipment maintenance not only improves the experience for the doctor and his staff but also for the patient. With that, I'll continue on Slide #8. So most dialysis patients receive HD treatment in an in-center setting. And here, we want to address market needs not only by reducing cost of the product side but also by tackling the total cost of care. That's really the personalized prescription, which is an important lever here and anemia management, in particular, a great example. So anemia management with ESAs is a challenging task in hemodialysis patients since their response to treatment varies highly. Fresenius Medical Care has developed a virtual trial environment to optimize anemia management and thereby reduce costs significantly. So this approach uses the collection of virtual representations of real patients, we call them avatars, in which trials based on different types of ESA can be simulated. This allows a rapid and effective comparison of different ESA algorithms with respect to cost and attainment of hemoglobin levels. Besides anemia, we are driving further projects that address the optimization of the individual prescription and management towards personalized care and drug prescription. Reducing the total cost of ownership is an important driver for the development of our global HD platform. Let me mention just one example here. Our new global platform, [ 5008S Diamond ] will soon become available in the United States. It enables saline-free dialysis, new therapy options and offers a high level of automation, thereby the system reduces overall cost per treatment and saves time for the clinical staff. And when I talk about platform, there's more than just the machine. It's the machine that comes with a number of new components such as bloodlines, dry concentrates, dialyzers and also disinfectants. Let's move to dialyzers. Our new dialyzer, FX Coral has just been launched at the EDTA this year. It combines all the great features of our FX line with an enhanced hemocompatibility membrane, and we have done more than 1 million treatments already. Various studies proved superiority. As we are leaning on existing manufacturing lines, we are now able to ramp up really fast and are seeing a fast adoption of the new technology. At our 2020 Capital Markets Day, we have also introduced the Optiflux Enexa dialyzer, and I'm pleased to provide you an update today. With the transformative membrane surface technology of Optiflux Enexa, we were able to improve the characteristics of filter membranes by adding new compounds to the spin mass and thereby successfully increase hemocompatibility. It is our ultimate goal to provide heparin-free outpatient hemodialysis treatments via the therapy system and to reduce hospitalization rates triggered by heparin intolerance and bleeding events after treatment. As a first step, Optiflux Enexa is 510(k) cleared by the FDA for commercial use in the United States. And we have completed clinical studies both for safety and for confirming the efficacy. I'm really happy to report that the initial study results for heparin-free dialysis are very promising. With the launch of this product, we are confident to not only set new industry standards but also to innovate the way we treat dialysis patients. With that, let's move to Slide #9. Global organ shortage is a major hurdle in transplantation. In the U.S. alone, 96,000 patients are on the waiting list for kidney transplant, and the actual transplant market is even bigger, 435,000 patients that are not on the waiting list today but they could be eligible for a kidney transplant. With our investment into eGenesis, we are addressing the global organ shortage as well as the identified market potential. So the gene editing and genome engineering company, eGenesis, is developing a multiplex platform based on CRISPR-Cas9 technology, and it aims to enable the safe and effective transplantation of renal organs from pigs into humans. With these xenografts, we see the potential to establish a completely new product market, but there's more to come. Another piece of the puzzle is to build our vertical integration model also in kidney transplantation and thereby use opportunities provided by service business models. To this end, we have recently expanded the capabilities of our global medical office. As part of our holistic approach to kidney therapy, we have created the position of head of transplantation medicine. This is supposed to further drive our efforts to expand access to and understanding of transplant medicine. Granted xenotransplantation is not around the corner, but we expect to see global medical trials in humans in the next 5 to 10 years. So if the test results are positive, this would create additional business opportunities for Fresenius Medical Care and change the medical landscape significantly. Other organs such as heart and lungs would be affected by such a step as well. I'll continue on Slide #10. Our critical care business has continued to flex to meet the needs of the pandemic. 1/4 of all patients hospitalized with COVID-19 develops acute kidney injury, and especially at the beginning of the pandemic, this led to an increased demand for our acute care products. To prevent misinterpretation, I would like to point out that the proportion of patients who then require permanent dialysis after the COVID diseases over is much, much lower. At Fresenius Medical Care, we have an extensive and deep knowledge in extracorporeal treatment, and we are leveraging this expertise not only to further expand but also to further personalize the therapy offerings to patients in critical conditions. And this will enable us to address different patient segments also beyond dialysis. I would like to highlight 2 new therapy systems for our critical care portfolio here. The first one is Xenios i-cor. So that's a synchronized pulsatile cardiac support system. It's really our answer to addressing the medical need for cardiogenic shock and high-risk percutaneous coronary intervention treatments. Different to the constant pressure of the regular ECMO therapy, this new and innovative technology respects the physiology of the cardiovascular system. That's avoiding working against the patient's heart. This is done via an ECG-triggered pulsatile support in the diastole only and thereby imitating the natural pulse of the human heart. By introducing our new technology, we are able to address the treatment for the globally growing cardiovascular disease market, in particular cardiogenic shock and acute myocardial infraction. After completing 2 clinical trials, we started rolling out this treatment in selected European countries. Another highlight is the great success of our multiFiltrate pro platform. The strong growth in acute dialysis products in 2020 has been followed by continued strong growth in '21 globally. The pandemic allowed us accelerated market access in China by accelerating approvals and an even faster registration process in the U.S. With this, we have placed a large number of devices into the markets, which sets the base for our future global growth. Additional drivers for growth were not only the unfortunate COVID-19 pandemic, but also the possibility to combine lung support via carbon dioxide removal in combination with [ MFT pro]. Overall, the reliability and usability and the broad therapy offering covering kidney, liver, lung, sepsis therapies as well as desensitization in pre- and post-transplantation patients, together with our citrate calcium anticoagulation approach are really key success factors for these therapies in the critical care. With that, I move on to Slide #11. So most of our patients not only suffer from renal disease but also from a number of comorbidities such as diabetes, cardiovascular or liver disease or even cancer. And in order to expand our therapy offerings accordingly and implement a holistic approach, non-renal products become an important driver for our future product portfolio. We are looking for those complementary assets where we can create value add either by leveraging our core competencies directly or where the asset would increase the value of our existing network. In doing so, we always keep our patient-focused approach in mind. FMC Ventures, as mentioned, our venture fund is a key instrument to get access to these promising technologies. I would like to mention at least some examples here. Mental health company Tridiuum is about using digital tools for further optimizing the behavioral treatment process. And the goal is to improve patient compliance and managing comorbidities also beyond CKD. In the area of cardiovascular disease, we have a stake in a provider of renal decongestion system called Magenta, which reduces renal venous pressure. Equally impressive to me personally is another portfolio company, Vectorious, that develops implantable medical sensors that are able to monitor heart pressure changes already before symptoms. With that, I move to Slide #12 for a brief summary. So I hope that my remarks have provided you with an interesting insight and have underlined how large the variety of internal and externally sourced innovations are driving Fresenius Medical Care growth in all areas of our strategy. And as the leading and only vertically integrated provider in the market, we truly understand the challenges and needs of our patients and customers in the renal care continuum. Our deep expertise and long-standing experience enables us to innovate in the dialysis market in order to leverage growth potentials, reduce cost of care and most important, improve the treatment quality. Outside of our core business in critical care and also in complementary assets, our patient centricity and the personalization of care as part of our increasingly holistic therapy approach are important drivers for innovation. With that, I come to an end of my prepared remarks, and I'm looking forward to answering your questions. Back to you, Dominik.

Thank you, Olaf, for the great update and insights and fascinating innovations that are in the pipeline or just launched. I know that R&D is a bit outside the comfort zone of most of the capital market participants, so you might need to explain more. And with that, I hand over to Natalie to open the Q&A.

[Operator Instructions] The first question is from the line of Lisa Clive from Bernstein.

Just a few questions. Number one, in terms of the heparin-free approach to dialysis and some of the other things that you're trying to do to improve basically the clearance as well, I know Baxter has a dialyzer in the market in the U.S. which is supposed to be able to take away -- take out the larger molecules better. Could you talk about that and whether that's also an area of focus for Fresenius Medical Care, sort of pros and cons of that approach? That would be helpful.

So thanks, Lisa, for the question. Absolutely. So I think the whole topic of removing middle molecules and larger molecules and the overall clearance has been a topic since quite some time. This is why many markets have adopted so heavily HDF. At the same time, there are also some risk associated with that. If you open the port of your dialyzer too much, you also take out the good stuff. So there are things like albumin, as an example, you've got to be careful that you do not remove too much. So putting this into perspective, what you typically do when you're designing a dialyzer membrane, you modify the port size to a level that you keep albumin inside of the patient, let this one not leak out. How are you doing that? You typically have your fiber material that is polysulfone or polyethersulfone, sorry for becoming technical now, and you add some solvent to the spin mass, which is typically PVP. And the question of how much of the solvent you put in, you can modify port size. So this is not really rocket science. It is a very regular engineering process. The art is to find the right cutoff that you open the port size not too much. So this is all about the magic of designing such a membrane. The key for us is always making sure we do not take out too much albumin of these patients. When you talk about the heparin-free that you referred to, this is something that's using a completely different approach. So opening port size that is smaller, larger, this has been going on for a long time because it's typically playing around with the manufacturing process. When we are talking about the heparin-free treatment, we are going to a completely different approach because we add a new compound, a new polymer into that spin mass. We call this polymer Endexo. That's basically -- yes, it's a polymer that is modifying the surface -- the inner surface of the membrane in a way that it becomes somehow inert or basically components of the blood cannot attach to the surface anymore, so-called platelets. With that understanding that there are -- is around 1.2 square meters of membrane surface the blood is passing through, it is super crucial that this surface has the right condition. So with our Endexo we are able to modify this in a way that we are super hemocompatible. And with that, we see a significantly reduced tendency of the blood to start the clotting cascade, which is basically the process where the clot starts to happen, the coagulation starts to happen. And this is why significant amounts of heparin have been administered. As said, we have just done some initial trials of that, but we are convinced that these trials look so far very, very positive. Sorry for the long answer to a short question.

No, that's helpful. And then this isn't quite a question for you because it's really not an R&D problem, but the early detection of CKD is clearly something that would be great to be able to do. But how do you -- how can you do it seeing as you're a dialysis provider who often doesn't see these patients until it's already too late?

Yes. I think there are basically 2 main components to that. First, you got to make sure that you have the network because, as you exactly said, if you have the patient in your dialysis clinic, this is too late. But to utilize the network of nephrologists, which we do, in fact, have, this is opening up this channel exactly, right? So the second one is much more difficult, and this is what is the right technology to detect these early stages of CKD. And there's a variety of technologies under development. Some are based on biomarkers. Some others are based on analyzing the analytics or even some of the mentioned apps where basically the behavior of certain patients is analyzed and you try to find some patterns. With that, you can then identify these patients earlier than you can do this today. But a lot of this is -- you're absolutely right, is not mature enough to be a finished product. However, there's a lot of research ongoing to get there.

And maybe a small add-on from the non-R&D technical side. The contracts -- some of the contracts like the one we announced with Humana, where we work with the nephrologists and the Humana patient population for early detection, we have already 20,000 patients under management for CKD. So that is -- that goes in that direction. Lisa, you're right, once they are in the clinic, nothing to do about CKD management anymore.

The next question is from the line of Oliver Metzger from ODDO BHF.

The first one is on market potential. So you've described that basically above 90% identify CKD too late. So it would be interesting to know your view about how would the market expand if just the patients become more aware about CKD detections earlier. So in a perfect world, patients go through PD, followed by HHD and then entering in-center HD at one point of time, so mortality should also be lower. So just a few comments on that, please. My second question is one point which was basically not described in your presentation is about the point of genetic disposition, which was mentioned by Frank Maddux , I think, in a similar format 1 year ago. But in my view, it fits perfectly also into this presentation. So it would be great if you can just give your view on that and how R&D progresses for genetic disposition.

Oliver, so we won't talk about market potential. But of course, you're absolutely right, the earlier you go in CKD management, the longer you can push out patients moving to end-stage renal disease. And you can ensure with the right medication like with SGLT2 inhibitors. Should they finally come to the market and support what they say they should be doing, you will have, as Frank also outlined, way healthier patients from a cardio system, and we will have more patients actually progressing to end-stage renal disease because they don't die of cardio disease before. So we will have more and healthier patients as a consequence of that in the very much future, I would say, so not next year. But I think that's all we can say to that from a market potential perspective. And for the second, I would hand over to Olaf.

Yes. Thanks, Oliver. Absolutely. So the whole topic of genome sequencing for the patients is one of the big topics. And you're absolutely right, Frank elaborated on this in his expert call. We try to keep the overlap as small as possible between the 2 presentations that's why I didn't bring it up again. It is something that is ongoing, that is super fascinating, and it adds simply another puzzle piece to the overall analytics of the data sets that we are basically analyzing with our team. So we have a lot of the existing patient data based on diagnosis, based on the various types of sensors we are regularly applying, based on the blood samples we are getting regular from these patients. But at the same time, to put this into perspective with the sequencing of the genome of the specific patient gives a completely different insight on predicting the progression of the disease. This also refers, by the way, to Lisa's questions earlier on. So how can these earlier stages of CKD better detect? And if so, how can you prevent or how can you predict also the progression of this disease moving forward?

The next question is from the line of Tom Jones from Berenberg.

The first one is quite a general one really. You've given us an awful lot of information about different areas of R&D and different opportunities. But for us analysts that need to go away and sort of boil this down into something that we can stick in our models, what are the top 3 things going on within your R&D effort at the moment that really get the company excited and really are the big things within FMC? And then the second question just really, I guess, pertains to the critical care business. If I look at your sister company, a lot of the products that they make are quite similar to some of the products you make. So it would be helpful to kind of understand how the 2 organizations leverage each other's capabilities and spending, I guess, both from a development and perhaps even from a commercial perspective.

Thanks, Tom. Great questions. So for the -- you ask an engineer for the top 3 technologies, you talk for 2 days, but I will try to limit it to 2 minutes. So what I feel are currently within our space the most exciting technologies, I would really start with the data. This is where we put the biggest investment in since we have so much of these data more than anyone else, and we can read so much in terms of patterns, in terms of the progression of the disease. We can read technical data. We can predict maintenance of a certain system. There is so much more, and we're exploring more and more every day. So this is my top one. The second one is really new membranes. And I think this heparin-free sounds maybe small but it is huge. It's such a burden for the patient. It's something where the tendency to bleed not only right after the treatment but hours after is so high, the cross-effects are so high. And this has been with dialysis since ever. If we can reduce this to an acceptable limit or what we currently are aiming for, to eliminate it completely, this would be really a game changer in dialysis. And it would be, quite frankly, in HD, probably the biggest ones since the last 25 years. I think the third one that I would mention here just from my perspective was really the launch of the 6008 system. It's a fully integrated cassette-based system. This has also not happened before, and we see an incredible excitement of our users to use it. Moving forward, the cost of treatment in the in-center setting, the majority of these costs will be driven by personnel. It will not be the cost of the disposable. It will not be the drugs anymore. To the large extent, it will be the personnel. And the more we can automate, the more we can simplify, the more we can standardize, this, I think, is really adding the biggest value in the internal setting, which today accounts for 90% of the treatments roughly. Over the years, this might be reduced to some degree, but still will be a major part of the treatment. And therefore, this is what we are aiming for. To your second question, we are trying to leverage a number of synergies with FSE. I think we -- here, to be very clear, we are talking about Fresenius Kabi. They have a number of products that use some technologies or products where there is synergy. And there, we are leveraging as much as we can. Take for example solution bags as one. So we are talking not only on the R&D side, but we are also talking on the manufacturing side. We are leveraging also the infrastructure if it makes sense. When it comes really to approaching customers into the clinic, there is -- overlap is not as big anymore, as you might think. We have analyzed it here and there. There are, from time to time, also some areas where we are working together, but this is overall limited as we see it today. There are obviously, on a collegial base, a lot of interaction when it comes critical care with our Helios clinics and also the Quirónsalud clinics in Spain. So the easy access to the care setting always been on our mind. It is very straightforward when it comes to our dialysis clinics. It has not been so easy for critical care settings. Since they are operating so many of these hospitals in Europe, this gives them easy and very straight access for our engineers but also scientists to learn with the user.

Perfect. That's very helpful. And just a quick follow-up on -- you mentioned your heparin-free product is in initial trials. When very roughly, if all goes to plan, should we expect to launch this product? Is this a kind of '23, '24 story? Or are we looking kind of late '20s for it?

So as I said before, we have actually registered the product. We are currently in the process of making sure we can manufacture it in larger quantities. So we expect to see the first sales of this product either this year or early next year in limited quantities. However, this is nothing you can scale up from day 0. And at the same time, we are -- as you referred to the study, we have basically concluded 2 studies. The first was safety. The second was efficacy. And as I said, the results are very promising.

The next question is from the line of Jo Walton from Crédit Suisse.

This may be my little bit of ignorance here, but how often do patients change -- I'm a patient. I've been recommended to have home dialysis. I -- recommended such and such piece of equipment. Where does the patient choice come into this? Do the patients understand this? Is it a question of just getting the scientists -- or the nephrologists to work with you? And do they have a sense where they would be back to the nephrologist or -- Fresenius nephrologists and they would look to say, "Well, you might have one innovation one day, but within a year or so, the other one will have it and so you stick within the panel of products?" Or do you see big changes potentially in market share? I mean perhaps using the heparin-free, do you -- does anybody else have a heparin-free due to come on the market in the next 5 years or so?

Yes, Jo. Thanks very much for these questions. So overall -- let's start maybe with the second question. Heparin-free is nothing that anyone else has today as a product business. However, what we typically do, we are not limiting these products to our own centers . So we are selling to third-party products -- third-party providers the same as for our own, and we are also making a big difference. So other large providers get access to our technology. When it comes to the selection process, this is, in fact, very different from country to country. There are some countries where -- especially in Asia Pacific where you have PD-first approach, for example, on day 1, you drop into dialysis -- or you need dialysis, the modality of choice is home. Only if there are very, very good reasons, you are transferred to the in-center setting. And there are other places where this is very much the discretion of the nephrologist. Other countries now, especially where patients become more and more empowered, this is where -- and the United States is one of these examples, where this choice is more and more one also to be owned by the patient. Then the question what is the system of choice. There are obviously large networks, take -- InterWell Health being one of them. It's a large network of nephrologists, and there is know-how available. What is the right product? What is the right modality of choice for the individual patient? And typically, it's a decision that is taken between the nephrologist and the patient together.

Next question is from the line of David Adlington from JPMorgan.

Also again on the heparin-free potential. I just wondered how much heparin is used in a typical treatment and therefore, how much the new platform could potentially save a center.

David, it depends, again, very, very much on the country. There are some countries where this is very much commoditized and other countries where you have more high-quality, high-cost heparin. The typical -- in developed countries and high-volume countries, you could typically calculate with a number of around EUR 1 to EUR 2 for the heparin administration. This is just the drug. Of course, there's process cost associated with this. So you need to pay the syringe if there's not a prefilled syringe. You need to store it somewhere, and you need to document it somewhere. And someone needs to do the work, like a nurse. I do not have an exact number, and this, of course, depends very much on the country it is used in.

The next question is from the line of James Vane-Tempest from Jefferies.

I have 2, if I can, please. Firstly, which are the innovations in development do you think will best support the company's efforts in value-based care to manage patient risk most effectively? And the second question is just on Slide 11 with the external innovations. Just wondering which ones you're most excited about and is the greatest opportunity for the company.

Yes. Thanks. Great questions. So value-based care, from my perspective, there are a lot of smaller technologies contributing to this. This is more the evolutionary approach of step-by-step innovations. From my perspective, biggest step here is the analytics -- the predictive modeling of the data and the analytics of the data. We have so many of these patient data, and we can by now already predict the progression so much better and with that, also predict what is the right prescription and what is the right treatment of this specific patient. This is not only limited to renal care, but also to treat the comorbidity. So from my perspective, this is the one thing to have an eye on, to make sure that enough data is available, that enough data is sensed. That requires also a lot of sensors either in the center or at the patient's home to actually get this insight and then have the right predictive models available to make sure we get the insight to know what is the best treatment for this specific patient to keep him or her out of the hospital. So when it comes to the most fascinating external innovation, only from my perspective, there's one clear #1, which I think has a lot of risk but huge opportunity. And this is, again, the xenotransplantation that I referred to before. So this ability to kind of revitalize xenotransplantation, which has been deemed dead, what, 15 to 20 years ago, revitalize this technology by the CRISPR-Cas technology, modifying the genome of the pig in a way that the immune reaction of the human body is significantly lower compared to where it was in the past. And with that, if this is successful -- and at least in nonhuman primates, it has been proven to be successful to some degree. If this can be proven in clinical studies, this would lead to basically unlimited supply of organs with a function that could, in principle, mimic the function of the human kidney. If this is coming true, and I hope that I will still be able to be part of that, this could be a huge step for the whole patient population and basically provide a much different life to many of the patients we are currently treating with dialysis.

There are no further questions at this time. So I hand back to Dominik Heger for closing comments.

Okay. So thank you very much for the active participation despite it being a bit more of a complex topic than what we normally discuss. Thank you for your interest. And Olaf, again, thank you for spending the time with us. That was great. And with that, we will close it. Thank you very much.

Thank you.

Ladies and gentlemen, the conference has now concluded, and you may disconnect your telephone. Thank you for joining, and have a pleasant day. Goodbye.