A. History and development of the Company General Fresenius Medical Care AG is a stock corporation (Aktiengesellschaft or AG) organized under the laws of Germany, formerly known as Fresenius Medical Care AG & Co. KGaA, a partnership limited by shares (Kommanditgesellschaft auf Aktien or KGaA). FME AG is registered with the commercial register of the local court (Amtsgericht) of Hof (Saale), Germany, under the registration number HRB 6841. Our registered office (Sitz) is Hof (Saale), Germany. Our registered business address, and our principal office, is Else-Kröner-Strasse 1, 61352 Bad Homburg, Germany, telephone +49-6172-609-0. 21 Table of Contents History The Company was originally incorporated on August 5, 1996 as a stock corporation. On September 30, 1996, we completed a series of transactions to consummate an Agreement and Plan of Reorganization entered into on February 4, 1996 by Fresenius SE (then Fresenius AG) and W.R. Grace & Co. which we refer to as the “Merger” elsewhere in this report. Pursuant to that agreement, Fresenius SE contributed Fresenius Worldwide Dialysis, its global dialysis business, including its controlling interest in Fresenius USA, Inc., in exchange for 105,630,000 FME AG ordinary shares. Thereafter, subsidiaries of Fresenius SE merged with and into: ● W.R. Grace & Co., whose sole business at the time of the transaction consisted of National Medical Care, Inc., its global healthcare business; and into ● Fresenius USA, Inc., pursuant to which W.R. Grace & Co. and Fresenius USA, Inc. became wholly owned subsidiaries of the Company and the shareholders of W.R. Grace & Co. and the shareholders of Fresenius USA, Inc. (other than Fresenius SE) exchanged their shares for 94,080,000 FME AG ordinary shares, and 10,290,000 FME AG ordinary shares, respectively. On February 10, 2006, the Company completed the transformation of its legal form under German law from a German AG to a KGaA with the name Fresenius Medical Care AG & Co. KGaA, as approved by its shareholders during the EGM held on August 30, 2005. The Company as a KGaA was the same legal entity under German law, rather than a successor to the stock corporation. As noted in “Certain defined terms” above, on November 30, 2023, the Company’s legal form was changed from a KGaA to an AG having the legal name Fresenius Medical Care AG with Management AG exiting the Company and Fresenius SE ceasing to have control of the Company (as defined in IFRS 10). Information regarding authorizations granted by our Annual General Meeting (AGM) to conduct share buyback programs and reconciliations of any treasury share purchases, repurchases, and retirements under such programs can be found in note 20 of the notes to the consolidated financial statements included in this report. The most recent authorization granted in May 2021 was confirmed at our 2023 EGM. For further information, see Item 16E. “Purchase of equity securities by the issuer and affiliated purchasers” and note 20 of the notes to the consolidated financial statements included in this report. Effective December 31, 2025, pursuant to an agreement signed on October 17, 2025, Fresenius Medical Care Deutschland GmbH purchased the Company’s production sites in Schweinfurt and St. Wendel, Germany, which were previously leased from Fresenius SE and certain of its affiliates (collectively, Fresenius SE Companies), for a total transaction cost of €181 M (including a purchase price paid to Fresenius SE Companies in the amount of €171 M). For further information, see note 6 of the notes to the consolidated financial statements included in this report. On August 24, 2022, we completed a business combination including Fresenius Health Partners, Inc. (FHP), the value-based care division of Fresenius Medical Care North America. The new company, which operates under the Interwell Health brand (Interwell Health) and comprises our Value-Based Care segment, combined FHP’s expertise in kidney care value-based contracting and performance, InterWell Health LLC’s clinical care models and network of around 1,700 nephrologists and Cricket Health, Inc.’s (Cricket) tech-enabled care model that utilizes its proprietary informatics, StageSmart™ and patient engagement platforms. We aim to significantly improve the care of patients with chronic kidney disease and further expand our leading position in value-based care. In the third quarter of 2025, we settled put options held by non-nephrologist investors in connection with the business combination, increasing our ownership of Interwell Health from 75% to 92%. For further information, see note 26 of the notes to the consolidated financial statements included in this report. In December 2023, we completed the divestiture of National Cardiovascular Partners (NCP), comprising 21 facilities providing outpatient cardiac catheterization and vascular laboratory services, which were previously included in the Care Delivery segment of our U.S. healthcare service business. The NCP divestiture was effected as part of our review of our business portfolio, mainly due to exiting unsustainable markets and divesting non-core businesses, as well as the cessation of certain R&D programs to enable more focused capital allocation towards areas in our core business that are expected to have higher profitable growth (Legacy Portfolio Optimization). Additionally during 2025, we divested our renal dialysis clinic facilities in Brazil, Kazakhstan, and Malaysia and select assets of our wholly owned Spectra Laboratories while in 2024 we divested our service businesses in Chile, Ecuador, Sub-Saharan Africa, Türkiye, Guatemala, Curacao, Peru, Colombia, and the Cura Day Hospitals Group in Australia, all in connection with the Legacy Portfolio Optimization plan. Further information regarding our divestitures as well as assets classified as held for sale, see notes 3 and 4 of the notes to the consolidated financial statements included in this report. 22 Table of Contents For further information regarding important events in the development in our business, such as material mergers by us or our significant subsidiaries, acquisitions and dispositions of material assets outside the ordinary course of our business, material changes in the way we conduct our business, material changes in the products we produce and the services we provide, see Item 4, “Information on the Company,” in this Annual Report on Form 20-F for the year ended December 31, 2025 and our reports for prior years, filed with the SEC and also available on our website www.freseniusmedicalcare.com. In furnishing our website address in this report, however, we do not intend to incorporate any information on our website into this report, and any information on our website should not be considered to be part of this report, except as expressly set forth herein. For information regarding our principal capital expenditures and divestitures since the beginning of our last financial year, and information concerning our principal capital expenditures and divestitures currently in progress, see Item 4, “Information on the Company — B. Business overview — Capital expenditures” and “— Acquisitions and investments” as well as Item 5, “Operating and financial review and prospects — III. Financial position — Net cash provided by (used in) investing activities.” The SEC website contains reports, proxy and information statements and other information regarding registrants that file electronically with the SEC. The SEC’s website is www.sec.gov. For additional information regarding the availability of periodic reports and other information concerning us, see Item 10.H, “Documents on Display.” B. Business overview Our business Fresenius Medical Care is the world’s leading provider of products and services for individuals with kidney diseases based on publicly reported revenue. As a vertically integrated medical technology (MedTech) and healthcare service company, Fresenius Medical Care combines medical device engineering and manufacturing expertise with comprehensive patient care. The incidence of kidney disease is increasing worldwide. A significant rise in the drivers of kidney disease, such as obesity, diabetes, and hypertension, has elevated it to a global public health epidemic. According to estimates, the number of people requiring dialysis globally is increasing at a rate of 4% to 5% each year and is expected to reach around 7 M people by 2035. Our care models, technologies, and partnerships position us to meet the growing demand for life-sustaining services and products that are vital to millions of people living with kidney disease worldwide. Kidney patients require therapy, pharmaceuticals, medical technologies, and products that meet their individual needs and preferences, regardless of where they receive treatment, whether in one of our treatment centers, a hospital setting, at home, or when traveling. In the three operating segments, Care Delivery (CD), Value-Based Care (VBC), and Care Enablement (CE), Fresenius Medical Care provides the full spectrum of healthcare services, systems, devices, technologies, products, and pharmaceuticals to deliver high quality care to people living with kidney disease around the globe. Through Fresenius Medical Care’s vertical integration, scope, and scale, we develop, manufacture, and distribute medical devices, systems, pharmaceuticals, and products for kidney care to customers in more than 140 countries (2024: around 150). As of December 31, 2025, we operate 3,601 (2024: 3,675) dialysis centers in more than 30 countries worldwide (2024: around 40), serving 291,902 dialysis patients (2024: 299,352). Fresenius Medical Care manages the world’s largest network of dialysis centers and has 35 production sites in 19 countries (2024: 39 production sites in 19 countries). 23 Table of Contents Our products and services Our products and services for 2025 are shown in the following chart: For information regarding the divestiture of business providing certain of these services during 2025, see note 3 and note 4 of the notes to the consolidated financial statements. In 2025, approximately 4.5 M (2024: 4.3 M) patients worldwide regularly underwent dialysis treatment. Dialysis is a life-saving blood cleansing procedure that substitutes the function of the kidney in case of kidney failure. Healthy kidneys clean the blood of waste products, regulate water levels, and produce important hormones. Chronic kidney failure or end stage kidney disease (ESKD) (also referred to as ESRD) occurs when the kidneys are irreparably damaged and are no longer able to function adequately over a sustained period of time. Many diseases can lead to chronic kidney failure, particularly diabetes, chronic nephritis, or hypertension. There are currently two treatment options for ESKD: kidney transplant and dialysis. For a summary of our revenues attributable to our major categories of activity, split by operating and reportable segments as well as by regions, for the three years ended December 31, 2025, 2024, and 2023, see notes 5 a) and 29 of the notes to the consolidated financial statements included in this report. 24 Table of Contents We receive a substantial portion of our Care Delivery revenue from the U.S. Medicare program and other government sources. The following table provides information for the years ended December 31, 2025, 2024, and 2023 regarding the percentage of our U.S. patient service revenue included in our healthcare service revenue from: (a) the Medicare program, (b) private/alternative payors, such as commercial insurance, Medicare Advantage, and private funds, (c) Medicaid and other government sources, and (d) hospitals. ​ ​ ​ ​ ​ ​ ​ U.S. patient service revenue ​ ​ ​ ​ ​ ​ in % of U.S. patient service revenue ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ 2023 Medicare program 19.0 ​ 22.1 ​ 24.5 Private / alternative payors 72.4 ​ 69.2 ​ 67.2 Medicaid and other government sources 4.7 ​ 4.5 ​ 4.0 Hospitals 3.9 ​ 4.2 ​ 4.3 Total 100.0 ​ 100.0 ​ 100.0 ​ Under the Medicare program, Medicare reimburses dialysis providers for the treatment of certain individuals who are diagnosed as having ESRD, regardless of age or financial circumstances. See “Regulatory and legal matters — Reimbursement.” Dialysis treatment options for ESRD CKD is a global epidemic. The number of patients requiring kidney replacement therapy is increasing worldwide: At the end of 2025, about 5.5 M patients (2024: 5.3 M) underwent dialysis treatment or received a donor organ. Further information can be found in the table below: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Patients with end stage renal disease ​ ​ ​ ​ ​ ​ ​ ​ in M (rounded) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 2025 ​ ​ ​ Share in % ​ ​ ​ 2024 ​ ​ ​ Share in % Patients with end stage renal disease ​ 5.5 ​ 100 ​ 5.3 ​ 100 of which patients with transplants ​ 1.0 ​ 19 ​ 1.0 ​ 19 Of which dialysis patients ​ 4.5 ​ 81 ​ 4.3 ​ 81 In-center hemodialysis ​ 4.0 ​ 72 ​ 3.8 ​ 72 Peritoneal dialysis ​ 0.5 ​ 9 ​ 0.5 ​ 9 Home hemodialysis ​ <0.1 ​ <1 ​ <0.1 ​ <1 ​ A successful kidney transplant is considered the most effective treatment for ESKD, offering those patients a chance for a longer, healthier life. However, the number of organs donated worldwide has been significantly lower than the number of patients on transplant waiting lists for many years. Despite extensive efforts, particularly in regional initiatives, to raise awareness of kidney donation and promote willingness to donate, the global proportion of patients receiving a kidney transplant compared to other treatment methods has remained relatively unchanged and comparatively low over the last ten years. (See “— Regulatory and legal matters — Reimbursement — Executive order-based models” for a discussion of recent proposed changes to the U.S. organ donation system.) The prevalence of CKD varies between regions. There are several reasons for this: ● Countries differ in the demographics of their populations. ● Risk factors for kidney disease, such as obesity, diabetes and hypertension, varies widely. ● The genetic predisposition for kidney disease differs significantly around the world. ● Access to dialysis remains restricted in many countries, meaning that many patients suffering from CKD are not treated and therefore do not appear in available statistics. ● Cultural factors, such as nutrition, play a role. 25 Table of Contents The number of dialysis patients rose worldwide by around 4% to 5% in 2025 (2024: 4% to 5%). For information regarding new drug classes such as GLP-1 receptor agonists or SGLT2 inhibitors and their impact on patient populations, see note 2 a) of the notes to the consolidated financial statements included in this report. Comparison of dialysis treatment methods In 2025, most dialysis patients were treated in one of around 53,000 dialysis centers worldwide (2024: 52,000), with an average of approximately 80 patients per center (2024: 80). However, this figure varies considerably from country to country. Hemodialysis (HD) is by far the most common form of therapy for ESKD. In 2025 89% (2024: 89%) of dialysis patients worldwide received hemodialysis at dialysis centers. During the same period, 11% of dialysis patients worldwide underwent treatment at home (2024: 11%), mostly using peritoneal dialysis. In 2025, 11% (2024: 11%) of all dialysis patients were treated with peritoneal dialysis. Currently, less than 1% (2024: less than 1%) of all dialysis patients globally are treated with home hemodialysis. In the U.S., the share of patients treated at home is higher, with 15% (2024: 15%) receiving home dialysis. See below for brief descriptions of HD and PD. The following chart shows a comparison of in-center and home dialysis: We also provide dialysis services under contract to hospitals in the U.S. on an “as needed” basis for hospitalized ESRD patients and for patients suffering from acute kidney failure. Acute kidney failure can result from infections, sepsis, hypotension, toxins, systemic diseases, trauma, or other causes, and requires dialysis until the patient’s kidneys recover their normal function. We provide services to these patients either at their bedside, using portable dialysis equipment, or at the hospital’s dialysis site. Contracts with hospitals provide for payment at negotiated rates that are generally higher than the Medicare reimbursement rates for chronic in-center outpatient treatments. For acute kidney failure, the predominant treatment method is continuous kidney replacement therapy. Over 50% or around 1.1 M acute patients were treated with this method in 2025 (2024: over 50% or slightly more than 1 M). The number of patients requiring continuous kidney replacement therapy (CKRT) to treat acute kidney failure is set to rise from around 1.1 M patients in 2025 to over 1.5 M per year in 2035. In this field, we have a market share of approximately 30% (2024: 30%). For additional information regarding patient growth in this field, see “— Corporate strategy and objectives,” below. Hemodialysis. Hemodialysis removes toxins and excess fluids from the blood in a process in which the blood flows outside the body through plastic tubes known as bloodlines into a specially designed filter, called a dialyzer. The dialyzer separates waste products and excess water from the blood. Dialysis solution flowing through the dialyzer carries away the waste products and excess water and supplements the blood with solutes which must be added due to renal failure. The treated blood is returned to the patient. The hemodialysis machine pumps blood, adds anti-coagulants, regulates the purification process and controls the mixing of dialysis solution as well as the rate of its flow through the system. This machine can also monitor and record the patient’s vital signs. 26 Table of Contents At our clinics, we provide hemodialysis treatments at individual stations through the use of dialysis machines and disposable products. In hemodialysis treatment, a nurse connects the patient to the dialysis machine via bloodlines and monitors the dialysis equipment and the patient’s vital signs. The capacity of a clinic is a function of the number of stations and additional factors such as type of treatment, patient requirements, length of time per treatment, and local operating practices and ordinances regulating hours of operation. As part of the dialysis therapy, we provide a variety of services to ESRD patients at our dialysis clinics in the U.S. These services include administering erythropoietin stimulating agents (ESAs), which are synthetic engineered hormones that stimulate the production of red blood cells. ESAs are used to treat anemia, a medical complication that ESRD patients frequently experience. We administer ESAs to most of our patients in the U.S. ESAs have historically constituted a material portion of our overall costs of treating our ESRD patients. Peritoneal dialysis. Peritoneal dialysis removes toxins from the blood using the peritoneum, the membrane lining covering the internal organs located in the abdominal area, as a filter. Most peritoneal dialysis patients administer their own treatments in their own homes and workplaces, either by a treatment known as continuous ambulatory peritoneal dialysis (CAPD), or by a treatment known as continuous cycling peritoneal dialysis, also called automated peritoneal dialysis (APD). In both of these treatments, a surgically implanted catheter provides access to the peritoneal cavity. Using this catheter, the patient introduces a sterile dialysis solution from a solution bag through a tube into the peritoneal cavity. The peritoneum operates as the filtering membrane and, after a specified dwell time, the solution is drained and disposed. A typical CAPD peritoneal dialysis program involves the introduction and disposal of dialysis solution four times a day. With continuous cycling peritoneal dialysis, a machine pumps or “cycles” solution to and from the patient’s peritoneal cavity while the patient sleeps. During the day, one and a half to two liters of dialysis solution remain in the abdominal cavity of the patient. The human peritoneum can be used as a dialyzer only for a limited period of time, ideally only if the kidneys are still functioning to some extent. For our home dialysis patients, we provide materials, training and patient support services, including clinical monitoring, follow-up assistance and arranging for the delivery of supplies to the patient’s residence. (See “— Regulatory and legal matters — Reimbursement — U.S.” for a discussion of the ESRD PPS and billing for these products and services.) Care Delivery Our Care Delivery business segment encompasses our global network of dialysis clinics and includes services that address the complex healthcare needs and treatment choices for people living with kidney disease. In 2025, Fresenius Medical Care continued to support the entire spectrum of renal care for CKD and ESKD and are pioneers in dialysis as kidney replacement therapy. With our long history of kidney care and industry expertise, we leverage artificial intelligence (AI), analytics, technological capabilities, and platforms to support early interventions in care. The service portfolio of Care Delivery is shown in the following chart: 27 Table of Contents The Company’s dialysis clinic network comprises our 3,601 worldwide dialysis clinics (2024: 3,675), which provide various forms of in-center kidney replacement therapies. In 2025, we treated 70% (2024: 69%) of our patients in the U.S. and 30% (2024: 31%) internationally outside the U.S. To help improve in-center treatment adherence, the Care Delivery organization initiated many programs to encourage patients to stay with their dialysis treatments as prescribed. For instance, our Fresenius Kidney Care team in the U.S. piloted a program with Uber Health, LLC, (hereinafter referred to as Uber Health) and expanded the partnership nationwide in 2025. Uber Health is a healthcare-focused service by Uber Technologies, Inc., that provides non-emergency medical transportation. The Fresenius Kidney Care team is partnering with Uber Health for this transportation program to provide additional access to care for patients in need of life-sustaining dialysis treatment when other transportation options have been exhausted. As patients choose greater independence offered by home dialysis, two different options of home dialysis therapy – peritoneal dialysis (PD) and home hemodialysis (HHD) – are provided to meet different patient needs. Currently over 85,000 patients globally (2024: over 85,000) perform PD and HHD utilizing product solutions from Fresenius Medical Care. Care Delivery provides different forms of dialysis therapies for people living with ESKD and transplant referral coordination for eligible patients where offered, as illustrated in the following chart. Although our dialysis clinic network is the heart of the Care Delivery segment, the overall Care Delivery portfolio includes a range of services that meet the immediate and long-term needs of individuals living with kidney disease: ● Azura Vascular Care provides outpatient vascular care services to individuals requiring dialysis access management in the U.S. ● Frenova delivers a network of research sites, a diverse patient population, and the expertise to initiate clinical trials rapidly. This subsidiary works with partner sites to enroll suitable patients for renal trials and studies of adjacent conditions. Frenova also offers data analytics and licensing services, with access to one of nephrology’s largest longitudinal databases. ● Fresenius Medical Care Renal Pharmaceuticals produces as well as distributes kidney-disease related drugs and pharmaceuticals and includes our investment in Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP). ● Fresenius Physician Solutions provides practice support for nephrologists in the U.S., including management, development, and technology solutions. ● Fresenius RX pharmacy provides dialysis medications, delivered directly to dialysis centers or to patients at home in the U.S., or even when traveling. ● Spectra Laboratories provides renal-specific laboratory testing and processing. In February 2025, Fresenius Medical Care announced the divestment of select laboratory and testing assets to Quest Diagnostics Inc. The transaction closed in the fourth quarter of 2025 and the transitional process will continue into 2026. For additional information regarding our other healthcare services, see Item 3.D, “Key information — Risk factors and Item 4, “Information on the Company — Regulatory and legal matters — Reimbursement — U.S.” 28 Table of Contents High-volume hemodiafiltration In 2025, Fresenius Medical Care introduced HVHDF into clinical practice, with the goal of establishing it as a new standard of care in the U.S. dialysis industry. This therapy represents a significant opportunity to enhance patient outcomes and expand our presence in the U.S. dialysis market. In Europe and the Middle East, the Company has been treating patients successfully with HVHDF for more than a decade, underscoring its established benefits and potential for broader application. HVHDF is a kidney replacement therapy that combines both convection and diffusion to remove solutes from the body. Unlike conventional hemodialysis, which primarily uses diffusion, HVHDF incorporates high-volume convective therapy, infusing additional fluid and removing larger middle molecules. This therapy gained additional attention in 2023 with the release of the EU-funded CONVINCE study that compares the efficacy of HVHDF against high-flux hemodialysis (HF-HD). Starting in 2018, researchers observed more than 1,300 participants over two-and-a-half years. The results showed a 23% relative risk reduction in the hazard of all-cause mortality for patients treated with HVHDF versus HF-HD, as well as an improvement in patient-reported outcomes. In February 2024, Fresenius Medical Care’s 5008X hemodialysis system achieved a key milestone by becoming the first FDA-approved machine capable of delivering HVHDF in the U.S. Paired with our FX CorAL dialyzer, which was already available in the U.S., the 5008X combines advanced engineering and membrane technologies to enable HVHDF. In May 2025, the Company received FDA 510(k) clearance for the updated hemodiafiltration-capable 5008X CAREsystem. In order to establish HVHDF as a new standard of care in the U.S. dialysis industry, Fresenius Medical Care conducted a limited launch in selected Fresenius Kidney Care clinics in 2025, with a broader commercial launch planned for 2026 and beyond. As part of our long-term strategy, we are committed to replacing the entire installed base at Fresenius Kidney Care with the 5008X CAREsystem by the end of 2030, reinforcing our market leadership and driving adoption of this advanced therapy. Value-Based Care In 2025, Fresenius Medical Care introduced a new operating segment, Value-Based Care, which was previously part of Care Delivery in the U.S., as a key component of our FME Reignite strategy. This segmentation enhances the transparency of financial reporting, offering greater insight into the performance and drivers of each reporting segment. By leveraging Fresenius Medical Care’s vertically integrated structure – encompassing Care Delivery, Value-Based Care, and Care Enablement – the Company aims to accelerate innovation, improve patient outcomes, drive growth, and reduce costs. Value-Based Care drives innovation on the basis of risk-based delivery models that lower care costs by enhancing treatment quality and patient well-being, supporting planned (optimal) dialysis starts and fewer all-cause hospitalizations than the national average in the U.S. Our Value-Based Care entity, Interwell Health, leads the industry for value-based kidney care with three key differentiators: ● Connectivity to our U.S. clinic network ●The largest nephrologist network in the U.S., with over 2,200 physician partnerships ●The most widely adopted nephrology-specific electronic health record system in the U.S. The Value-Based Care segment achieves exceptional clinical outcomes, with optimal start rates over twice as high as the U.S. national average. In the U.S. government’s Kidney Care Choices (KCC) program, the majority of our aligned nephrology practices (called Kidney Contracting Entities or KCEs) are considered “high performers” by the program. Our KCEs contributed 80% of the entire KCC program’s gross savings in 2022 (based on the latest publicly published data available). 29 Table of Contents Care Enablement Our deep understanding of customer needs, combined with our profound engineering expertise, forms the foundation of Fresenius Medical Care’s Care Enablement segment. To effectively serve a wide range of market segments, Care Enablement is organized around three main therapy areas: in-center dialysis, home dialysis, and critical care. Each of these units is responsible for the full product life cycle – from ideation and creation to value generation, supply chain management, and service – through to the end of the product’s life. This comprehensive approach ensures the delivery of innovative and integrated therapies across all care settings. The products in Care Enablement’s portfolio are designed for blood purification as well as organ support and include medical devices for in-center hemodialysis and hemodiafiltration (HDF), dialyzers, concentrates for dialysate preparation, solutions and granulates, bloodlines, water treatment systems, home hemodialysis and peritoneal dialysis cyclers, peritoneal dialysis solutions, renal pharmaceuticals, acute cardiopulmonary products, apheresis products, data processing and analysis systems, and other medical devices. Building on this broad portfolio, Care Enablement applies an integrated business model that combines product innovations with technical service, clinical training, and global commercial execution. By leveraging its global reach, operational excellence, and trusted customer relationships, Care Enablement capitalizes on synergies across the value chain, strengthens long-term partnerships, and drives sustainable growth worldwide. Care Enablement offers healthcare products for acute and chronic kidney organ support in more than 140 countries globally, with a focus on the following therapies: ● Hemodialysis and hemodiafiltration: These are the most common therapies to support ESKD, the last stage of chronic kidney disease, and Care Enablement is recognized as the global leader in this field. Care Enablement provides a wide range of HD and HDF systems in dialysis centers as well as those designed for use at home. Enabled by Fresenius Medical Care’s vertically integrated business model, Care Enablement plays a pivotal role in making HVHDF broadly available also in the U.S.; and by expanding its patented sodium management tool is also advancing precision medicine in dialysis at scale. ● Peritoneal dialysis: In PD the patient’s peritoneum is used as a natural filter. Nearly all peritoneal dialysis is performed at home, and the Care Enablement portfolio includes systems and solutions for CAPD and APD. ● Acute dialysis: In case of a sudden loss of renal function, CKRT is used in intensive care units. Fresenius Medical Care also provides a comprehensive portfolio of products for this setting. Care Enablement’s portfolio includes dialysis systems and dialyzer options for kidney replacement therapies tailored to a wide range of clinical needs including low flux dialysis, high flux dialysis and hemodiafiltration, and offering solutions for diverse operational setups: covering every clinic, dialysis modality, patient segment, and every stage of life. The comprehensive home dialysis portfolio, including both PD and HHD, reflects Care Enablement’s strong commitment to this growing market. Care Enablement is making significant progress in connected health solutions – digitally linking patients and care teams to enable remote monitoring, seamless communication, and more coordinated care – with a strong presence in the U.S. and across other international regions. We also offer extracorporeal therapy options for patients who cannot be sufficiently treated through conventional pharmaceutical regimens, including the removal of metabolic products, toxins, autoantibodies, and immunocomplexes. Our Xenios AG (Xenios) products are used for a wide range of extracorporeal gas exchange and offer a wide range of heart and lung support from partial CO2 removal up to full oxygenation. Xenios’s Novalung® is the first extracorporeal membrane oxygenation system to be cleared for more than six hours of continuous use as extracorporeal life support. 30 Table of Contents For the fiscal year 2025, healthcare products accounted for 22% of our consolidated total revenue (2024: 22%). The following table shows the breakdown of our dialysis product revenues into sales of HD products, PD dialysis products and other healthcare products. The following amounts exclude intercompany product sales: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Healthcare product revenue ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ in € M ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, ​ ​ 2025 ​ 2024 ​ 2023 ​ ​ Total ​ ​ ​ Total ​ ​ ​ Total ​ ​ ​ ​ product ​ ​ ​ product ​ ​ ​ product ​ ​ ​ ​ ​ ​ revenues ​ ​ ​ % of total ​ ​ ​ revenues ​ ​ ​ % of total ​ ​ ​ revenues ​ ​ ​ % of total Hemodialysis products ​ 3,453 ​ 78 ​ 3,391 ​ 80 ​ 3,253 ​ 80 Peritoneal dialysis products 358 8 ​ 358 8 ​ 359 9 Other 603 14 ​ 502 12 ​ 448 11 Total 4,414 100 ​ 4,251 100 ​ 4,060 100 ​ Renal pharmaceuticals We continue to acquire and in-license renal pharmaceuticals to improve dialysis treatment for our patients. Below are the primary renal pharmaceuticals we have acquired or for which we have obtained licenses for use: PhosLo® In November 2006, we acquired PhosLo®, a calcium-based phosphate binder. Phosphate binders keep phosphorus levels in ESRD patients in a healthy range by preventing the body from absorbing phosphorus from foods and assisting the passing of excess phosphorous out of the body. We have received approval of PhosLo® in selected European countries. In October 2008, a competitive generic phosphate binder was introduced in the U.S. market, which reduced our PhosLo® sales in 2009. In October 2009, we launched an authorized generic version of PhosLo® to compete in the generic calcium acetate market. In April 2011, the FDA approved our New Drug Application for Phoslyra®, a liquid formulation of PhosLo®. In 2023, we discontinued the sale of Phoslyra in the U.S., and in 2024 we discontinued the sale of an authorized generic version of PhosLo. Venofer® and Ferinject® In 2008, we entered into two separate and independent license and distribution agreements, one for certain countries in Europe and the Middle East with Vifor (International) Ltd., a subsidiary of Swiss-based CSL Vifor (formerly Vifor Pharma Ltd.) and one for the U.S. (with American Regent, Inc. (formerly Luitpold Pharmaceuticals Inc.)), to market and distribute intravenous iron products; Venofer® (iron sucrose) and Ferinject® (ferric carboxymaltose) outside of the U.S. Both drugs are used to treat iron deficiency anemia experienced by non-dialysis CKD patients as well as dialysis patients. Venofer® is the originator intravenous iron sucrose product, a leading intravenous iron brand in terms of volume worldwide. Ferinject® is a leading intravenous iron therapy with market authorization in 87 countries as of October 2025 and more than 34 million patient years of experience. The first agreement concerns all commercialization activities for these intravenous iron products in the field of dialysis and became effective on January 1, 2009. In North America, a separate license agreement effective November 1, 2008, provides our subsidiary Fresenius USA Manufacturing Inc. (FUSA) with exclusive rights to manufacture and distribute Venofer® to freestanding (non-hospital based) U.S. dialysis facilities and, in addition, grants FUSA similar rights for certain new formulations of the drug. In 2017, Fresenius Medical Care Canada acquired the license to distribute Venofer® for ESRD and all indications in Canada. The license agreement has a term of five years with two additional two-year options. The U.S. license agreement has a term of ten years and includes FUSA extension options. In 2023, the North American agreement with American Regent was renegotiated and extended through December 31, 2028. The international agreement which had a term of 20 years was terminated in 2010 as a consequence of the establishment of Vifor Fresenius Medical Care Renal Pharma Ltd. In December 2010, we announced the expansion of our agreements with CSL Vifor by forming a new renal pharmaceutical company, VFMCRP, with the intention to develop and distribute products focused on addressing distinct complications and areas of chronic kidney disease; renal anemia management, mineral and bone management, kidney function preservation and improvement, conditions associated with kidney impairment and its treatment; and cardio-renal management. FME AG owns 45% of the company, which is headquartered in Switzerland. CSL Vifor contributed licenses (or the commercial benefit in the U.S.) to its Venofer® and Ferinject® products for use in the dialysis and pre-dialysis market (CKD stages III to V). CSL Vifor and its existing key affiliates or partners retain the responsibility for commercialization of both products outside the renal field. With effect as of November 2, 2021, Vifor Pharma Participations Ltd replaced Vifor Pharma Ltd as a shareholder of VFMCRP. 31 Table of Contents Velphoro® As part of the agreement to create VFMCRP, CSL Vifor also contributed the asset Velphoro® (sucroferric oxyhydroxide), a novel iron-based phosphate binder, to the new company (excluding certain rights within Japan). We market the product on behalf of VFMCRP in the U.S. and commercial sales of Velphoro® commenced in the first quarter of 2014 in the U.S. market. In January 2025, the phosphate binder class, including Velphoro® has been integrated into the U.S. dialysis reimbursement bundle with the product being separately billable under a transitional drug add-on payment adjustment (TDAPA) in 2025 and 2026 (see additional information under “— Reimbursement” below). Velphoro® has been approved in 51 countries and commercially launched in 40 countries worldwide and the VFMCRP partner Kissei also received approval from the Ministry of Health, Labour and Welfare in Japan during 2015 for the product which is marketed in Japan under the brand name P-TOL. In China, we received New Drug Approval in February 2023. For further information, refer to note 25 of the notes to the consolidated financial statements included in this report. OsvaRen® and Phosphosorb® In June 2015, VFMCRP, with CSL Vifor, was developed further. In addition to the iron replacement products Ferinject® and Venofer® for use in nephrology indications and the phosphate binder Velphoro® in our shared product portfolio, VFMCRP acquired nephrology medicines commercialized by us, including the phosphate binders OsvaRen® and Phosphosorb®. The transfer of the marketing rights was largely completed during the fourth quarter of 2015, allowing the company to further develop its sales and marketing in key European markets. Since early 2025, these products are currently not being sold subject to further regulatory clearance. Shared product portfolio The core of the VFMCRP model is to in-license products predominantly initiated or used by nephrologists as part of the following areas: renal anemia, mineral and bone and cardio-renal management, kidney function improvement and renal associated conditions in both dialysis dependent and non-dialysis dependent CKD. The in-licensed products are detailed below: Mircera® (methoxy polyethylene glycol-epoetin beta) is a long-acting ESA licensed from F. Hoffmann-La Roche AG since 2015 to treat anemia associated with chronic kidney disease. A cornerstone of VFMCRP’s franchise, Mircera® offers several dosing and administration benefits, making it a market-leading product in this category. The product is currently supplied to over 5,000 dialysis clinics in the U.S. and its territories. Retacrit® (epoetin alfa-epbx) is a short-acting ESA approved in the US in 2018 for all indications of its reference drug, epoetin alfa. Retacrit® is licensed from Pfizer Inc. since 2015 for certain channels, primarily comprising the U.S. non-hospital dialysis market and nephrology office practices. It is the first, and only, biosimilar ESA approved for use in the U.S. Rayaldee® (extended release calcifediol) is the first, and only, oral extended release formulation of calcifediol, a pro-hormone of the active form of vitamin D3, for the treatment of secondary hyperparathyroidism in CKD patients with vitamin D insufficiency. VFMCRP has an exclusive license agreement with OPKO Health, Inc., to co-develop and commercialize Rayaldee® in Europe (except Russia), Canada, Australia and Japan. In 2022, Rayaldee® was launched in Germany and Switzerland. Tavneos® (avacopan) is a first-in-class rare disease treatment for anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV) in adult patients. VFMCRP has licensed Tavneos® worldwide (except in the U.S., China, and other smaller Asian and Latin American countries) from ChemoCentryx, Inc., a wholly owned subsidiary of Amgen Inc. In the licensed territories, Tavneos® has been approved for the treatment of two main forms of AAV in Japan and, in combination with a rituximab or cyclophosphamide regimen, in the European Union (including Iceland, Liechtenstein and Norway), Canada, Great Britain, Switzerland, Australia, Kuwait, Israel, South Korea and Saudi Arabia. The therapy has been launched in over 20 countries across Europe, North America, Asia and the Middle East. Further launches are planned in the coming 36 months. In January 2026, the European Medicines Agency (EMA) has initiated a review of Tavneos® following concerns raised about integrity of data which had been provided with regard to a clinical trial which was the main study supporting the medicine’s marketing authorization in the EU. EMA will now review all available data to assess whether this emerging information has an impact on the balance of benefits and risks of Tavneos®. 32 Table of Contents Korsuva®™/Kapruvia®™ (difelikefalin) is the first product approved in EU and U.S. for the treatment of moderate-to-severe pruritus associated with CKD for adults undergoing in-center hemodialysis. Since 2022, VFMCRP has had a license agreement with Cara Therapeutics, Inc. (Cara) to develop and commercialize Korsuva/Kapruvia worldwide, excluding Japan and South Korea. In April 2025, VFMCRP signed an asset purchase agreement with Cara which included the transfer of all rights for Korsuva/Kapruvia and associated intellectual property. Fresenius Renal Pharmaceuticals and CSL Vifor agreed that both organizations would stop promotion of Korsuva in the US market, in 2024, following the 2023 CMS ruling that phases out the add-on payment after 2026. Neither organization has received a marketing fee since January 2024. Korsuva/Kapruvia is approved in the U.S., the EU, and other countries. Further key launches are expected in the next 12 months. VFMCRP also own the rights to Veltassa® (patiromer), a treatment for hyperkalaemia or elevated potassium levels, outside of the U.S. and Japan. In the licensed territories, Veltassa® was launched in 15 European markets as well as Israel, Saudi Arabia, United Arab Emirates, Kuwait, Australia, Canada (by partner Otsuka Canada Pharmaceutical, Inc.), and Japan (by partner Zeria Pharmaceutical Co., Ltd.). Global Medical Office Our Global Medical Office plays a pivotal role in contributing clinical expertise to Fresenius Medical Care’s management, offering counsel to business leaders while maintaining close communication on the state of medicine and science in kidney disease care with the aim to connect the right care to the right person at the right time by leveraging advanced data analysis and research, as well as providing educational resources for physicians. By providing end-to-end medical-scientific leadership and clinical governance, including the generation and translation of clinical evidence, the Global Medical Office was pivotal in enabling the launch of HVHDF in the U.S. Its coordinated efforts established the clinical confidence and governance framework required to safely initiate HVHDF in U.S. practice, thereby demonstrating the clinical feasibility of implementing HVHDF in the U.S. healthcare setting. The planned rollout of hemodiafiltration therapy across the Company’s U.S. Fresenius Kidney Care dialysis centers represent a critical advancement in kidney replacement therapy (KRT) to patients in the U.S., signifying a breakthrough for the nephrology community. Major markets and competitive position To obtain and manage information on the status and development of global, regional, and national markets, we have developed internal market analysis tools. We use these tools within the Company to collect, analyze, and communicate current and essential information on the dialysis market, developing trends, our market position, and those of our competitors. Except as otherwise specified herein, all market patient and other market data in this report has been derived using our internal market analysis tool. For some of these tools, country by country surveys are performed annually which focus on the total number of patients treated for ESRD, the treatment modalities selected, products used, treatment location, the structure of ESRD patient care providers, and other metrics. These surveys have been refined since inception to facilitate access to more detailed information and to reflect changes in the development of therapies and products as well as changes to the structure of our competitive environment. Questionnaires are distributed to professionals in the field of dialysis who are in a position to provide ESRD-relevant country specific information themselves or who can coordinate appropriate input from contacts with the relevant know-how in each country. The surveys are then centrally validated and checked for consistency by cross-referencing them with the most recent publicly available sources of national ESRD information (e.g. registry data or publications, if available) and with the results of surveys performed in previous years. All information received is consolidated at a global and regional level and analyzed and reported together with publicly available information published by our competitors. New and updated information from countries, along with refinements to internal market analysis tools, may lead to retroactive adjustments of previously made statements and estimates concerning future developments. While we believe the information contained in our internal market analysis tools and competitor publications to be reliable, we have not independently verified the data or any assumptions from which our internal market analysis tools are derived or on which the estimates they contain are based, and we do not make any representation as to the accuracy of such information. According to our estimates, the volume of the global dialysis market grew to around €81 to 85 BN in 2025 (2024: €80 to 84 BN). We estimate the following approximate breakdown for this market volume: around €16 BN (2024: €16 BN) for dialysis products and the remainder for dialysis services (including dialysis drugs). 33 Table of Contents The number of dialysis patients globally is increasing at a rate of 4% to 5% each year to around 4.5 M in 2025 (2024: 4.3 M) and is expected to reach around 7 M people by 2035, according to our estimates. Fresenius Medical Care is a global leader in dialysis care, providing treatment to about 7% of all dialysis patients (2024: 7%). At the end of 2025, we provided dialysis services for 291,902 people in our network of dialysis centers (2024: 299,352). The geographical breakdown according to patients treated can be found in the following chart: Fresenius Medical Care is also the global market leader for dialysis products in general. Products made for use in our own dialysis centers or for sale to third-party customers accounted for a market share of around 35% in 2025 (2024: around 35%). Furthermore, in hemodialysis products alone, Fresenius Medical Care is the leading provider, holding over 40% of the global market share in 2025 (2024: over 40%). Dialyzers for HD are the largest product group in the dialysis market with a worldwide sales volume of around 450 M units in 2025 (2024: 430 M). Approximately 171 M (around 38%) of these were made by Fresenius Medical Care (2024: 175 M or around 40%), giving us the biggest market share, by far. HD machines constitute another key component of our product business. Here, too, Fresenius Medical Care is the market leader. Of the estimated 110,000 machines installed in 2025 (2024: 100,000), around 56,000, or around 50% (2024: 51,000 or around 50%), were produced by Fresenius Medical Care. The Company holds the largest share of the HHD market. In 2025, more than 75% (2024: more than 75%) of all patients performing HHD utilized a dialysis machine from Fresenius Medical Care. Furthermore, Fresenius Medical Care holds a strong position in the market for PD products: Around 14% (2024: around 14%) of all PD patients use products made by the Company. The overall market for dialysis care services in the U.S. is consolidated. Across all market segments, Fresenius Medical Care treats around 37% of all dialysis patients here (2024: 37%). In the U.S., home dialysis is becoming increasingly important. In 2025, about 16% (2024: 16%) of our U.S. dialysis treatments were performed at home. Outside the U.S., the dialysis services business is much more fragmented. With 979 dialysis centers (2024: 1,051) and approximately 86,400 patients (2024: 92,900), Fresenius Medical Care operates the largest network of clinics. 34 Table of Contents Our competitive environment is described in more detail below: Healthcare Services. We operate in a competitive, international market environment and are, therefore, subject to certain trends, risks, and uncertainties that could cause actual results to differ from our projected results. The major trends affecting the markets in which we operate are: the aging population and increased life expectancies, shortage of donor organs for kidney transplants, and increasing incidence and better treatment of and survival of patients with diabetes and hypertension, which frequently precede the onset of ESRD, all of which contribute to patient growth. In the U.S. and other markets in which dialysis is readily available, additional trends are: Trends in the developed markets: ● improvements in treatment quality, which prolong patient life; ● stronger demand for innovative products and therapies; ● advances in medical technology; ● ongoing cost-containment efforts and ongoing pressure to decrease healthcare costs, resulting in limited reimbursement rate increases; ● reimbursement for the majority of treatments by governmental institutions, such as Medicare and Medicaid in the U.S.; and ● challenges in certain labor markets. Trends in the emerging markets: ● increasing national incomes and hence higher spending on healthcare; ● improving standards of living in developing countries, which make life-saving dialysis treatment available; ● consolidation of providers (e.g. hospital chains); ● consolidation of healthcare insurers with pricing pressure on providers; and ● privatization of healthcare providers. Our largest competitors in the dialysis services industry include DaVita, Inc., Diaverum AB, B. Braun SE, U.S. Renal Care, Inc., and Nephrocare Health Services Limited (NephroPlus). U.S. government programs are the primary source of reimbursement for services to the majority of U.S. patients and, as such, competition for patients in the U.S. is based primarily on quality and accessibility of service and the ability to obtain referrals from physicians. However, the extension of periods during which commercial insurers are primarily responsible for reimbursement and the growth of managed care have placed greater emphasis on service costs for patients insured with private insurance. In most countries other than the U.S., we compete primarily against individual freestanding clinics and hospital-based clinics. In many of these countries, especially the developed countries, governments directly or indirectly regulate prices and the opening of new clinics. Providers compete in all countries primarily on the basis of quality and availability of service and the development and maintenance of relationships with referring physicians. 35 Table of Contents Products: We compete globally in the product market which is largely segmented among in-center hemodialysis, peritoneal dialysis, home hemodialysis, and renal pharmaceuticals. Our competitors include: ​ ​ ​ ​ ​ Akebia Therapeutics, Inc. Guangdong Biolight Meditech Co., Ltd. Nipro Corporation Shandong Weigao Blood Purification Products Co., Ltd Ardelyx Inc. JMS Co., Ltd Outset Medical, Inc. Takeda Pharmaceutical Company Limited Asahi Kasei Medical Co., Ltd Mozarc Medical Holding LLC Physidia SAS Toray Medical Co., Ltd. B. Braun SE Nikkiso Co., Ltd. Quanta Dialysis Technologies Inc. Vantive Health LLC Bain Medical Equipment (Guangzhou) Co., Ltd Ningbo Tianyi Medical Appliance Co., Ltd. Sanofi S.A. ​ ​ We have invested significantly in developing proprietary processes, technologies, and manufacturing equipment which we believe provide a competitive advantage in manufacturing our products. Corporate strategy and objectives Introducing the new strategy At its Capital Markets Day in June 2025, Fresenius Medical Care introduced its new FME Reignite strategy. FME Reignite sets the ambition to deliver both industry-leading outcomes and margins with above-market growth, positioning the Company to lead kidney care through exceptional patient care and innovation. FME Reignite is based on three strategic priorities: strengthening our core operations, driving profitable growth and innovation, and developing and strengthening our culture. It reflects a greater focus on our overall portfolio, which has now been reorganized into three reporting segments including Value-Based Care as a new stand-alone segment. Our strategy is guided by our vision of “Creating a future worth living. For patients. Worldwide. Every day.” This takes Fresenius Medical Care from the successful transformation and turnaround phase of recent years to a new chapter of accelerated growth and innovation, designed to build on and strengthen our role as a leader in kidney care. Leveraging the power of vertical integration Vertical integration as the foundation for FME Reignite Vertical integration is at the root of Fresenius Medical Care’s business model and our FME Reignite strategy. It creates a basis to deliver industry-leading treatment, outcomes, and economics across our three operating segments, Care Delivery, Value-Based Care, and Care Enablement, as well as improve patient outcomes, unlock efficiencies, and reinforce synergies across kidney care. The Company is taking vertical integration to the next level and harnessing its capabilities across the different businesses. This means bringing together different parts of our organization with the goal of providing best-in-class products and services for our patients and customers. By doing so, Fresenius Medical Care is uniquely positioning itself to create value through a powerful cycle of innovation and care. 36 Table of Contents Introducing Value-Based Care as a new operating segment As part of the new strategy and in recognition of the growing importance of this field, Fresenius Medical Care introduced Value-Based Care as a separate segment, with the aim of sharpening the segment´s profile and boosting transparency. The segment comprises Fresenius Medical Care´s Interwell Health value- and risk-based care programs with public and private payors in the U.S. to provide long-term care to patients with CKD and ESKD. It leverages vertical integration through the company-wide use of patient and clinic data, treatment insights and medical innovation, and supports practice management and relationships with over 2,200 partner nephrologists, while aiming to reduce total medical cost. Transforming the standard of care with high-volume hemodiafiltration in the U.S. High-volume hemodiafiltration provided by Fresenius Medical Care’s 5008X CAREsystem aims to set a new standard in the treatment of kidney patients and is a good example of the benefits of vertical integration. With Food and Drug Administration (FDA) clearance secured, the Company prepared for commercialization in the U.S. in the course of 2025, with full market launch planned for 2026. HVHDF is supported by extensive international clinical evidence, e.g., the European-funded CONVINCE study, and results in improved patient outcomes compared with conventional hemodialysis. 37 Table of Contents Three key strategic priorities FME Reignite is founded on three levers to implement the strategy throughout the Company: ● Strengthening core operations: By delivering operational excellence with the Company’s core assets in its leading market positions, it will drive scalable, high-quality care to further enhance patient health and increase agility and operational efficiency through more standardized and improved operations as well as focused investments in technology and special programs. ●Driving profitable growth and innovation: By increasing R&D efficiency with a global product platform and products, targeting a new standard of care with the U.S. launch of high-volume hemodiafiltration, growing the clinic network in selected international markets, and driving AI-powered transformation in patient care, we will further drive profitable growth and enhance clinic outcomes and patient safety. ●Developing together and advancing our culture: By focusing on its people, Fresenius Medical Care intends to become the employer of choice in healthcare, attracting, retaining and engaging the best talent with a passion to make an impact, while living its new core values: We care. We connect. We commit. ​ New capital allocation framework Alongside its FME Reignite strategy, Fresenius Medical Care has introduced a new capital allocation framework which allows the Company to balance and achieve three objectives: investing in the core business, optimizing the capital structure, and returning excess capital to shareholders. The framework foresees a dividend payout ratio of 30% to 40%, complemented by a share buyback program with a total volume of €1 BN, which is expected to be completed in less than a year, significantly earlier than originally planned. The Company earmarks annual capital expenditures of around €0.8 BN to €1.0 BN between 2025 and 2030 to drive profitable growth in the core businesses and support innovation. Through 2030, the Company expects to generate operating cash flow of at least €2.5 BN annually to support the capital allocation framework. A strong balance sheet, financial flexibility, and a commitment to a sustainable investment grade rating are key aspects of the financial policy. As part of this consistent focus on our new dividend policy, Fresenius Medical Care lowered its self-imposed target band for the net financial leverage to between 2.5x and 3.0x (previously: 3.0x to 3.5x). This supports our stated goal of enabling attractive returns of excess capital to our shareholders. 38 Table of Contents Portfolio update Overall, Fresenius Medical Care is making strategic decisions about the market segments it invests in and how to ensure success in those segments, ensuring that the portfolio remains aligned with our strategy and supports the future direction of the Company. Measures undertaken to optimize our portfolio in 2025 included the divestment of clinic operations in a few countries, including Brazil, Malaysia, and Kazakhstan. Furthermore, we divested select assets of Spectra Laboratories in the U.S. in the fourth quarter 2025. Integrating sustainability In line with our FME Reignite strategy, sustainability continues to be an integral part of our business approach and supports our efforts across each of our strategic priorities. Sustainability is embedded in the Company’s vision, mission, and strategic planning, reflecting our commitment to addressing global healthcare challenges and maximizing the impact. Fresenius Medical Care manages sustainability risks and opportunities by prioritizing areas such as operational efficiency, customer needs and employer attractiveness. Our strategic sustainability goals are designed to create value for our business and stakeholders, with a focus on advancing care for patients, empowering people to contribute to a sustainable future, and driving sustainable operations and design. Sustainability performance related to patients and employees is directly tied to the short-term incentives for the Management Board and senior executives, while the long-term incentive plan is linked to our environmental performance. For further information, see “— Environmental Management” and Item 6.B, “Directors, senior management and employees — Compensation,” below. Medium-term aspirations The FME Reignite strategy is designed to enable Fresenius Medical Care to enter a phase of accelerated growth and innovation that builds on the Company’s successful turnaround and transformation processes. By leveraging vertical integration within our Company, focusing on our three strategic priorities, and allocating capital in a disciplined way, we aim to achieve superior outcomes for patients, supported by a strong physician network, and create sustainable value for our shareholders. The FME Reignite strategy supports our aspiration to achieve industry-leading profitability with an operating income margin in the mid-teens percentage range by 2030. Customers, marketing, distribution and service We sell most of our products to dialysis clinics, hospitals, and other specialized treatment clinics. A synergistic relationship among our sales, marketing, and R&D personnel enables real-world insights from the field to be incorporated into our product development process. We maintain a direct sales force of trained salespersons engaged in the sale of hemodialysis and peritoneal dialysis as well as acute dialysis products and products for critical care. International sales teams engage directly with healthcare professionals and, together with marketing, represent us at industry events, while our clinical nurses provide support, training, and assistance to customers. We offer customer service, training, and education in the applicable local language, and technical support such as field service, repair shops, maintenance, and warranty regulation for each country in which we sell dialysis products. Our distribution network is designed for efficiency, with products moving from factories to central warehouses, then to regional facilities. We also provide direct-to-patient delivery for home dialysis products and offer direct shipping to healthcare facilities for certain product lines. To maximize our reach, we employ a combination of local sales forces, independent distributors, dealers, and sales agents to ensure our products are accessible worldwide. 39 Table of Contents Sales of dialysis products to Iran We actively employ comprehensive policies, procedures, and systems to ensure compliance with applicable controls and economic sanctions laws. We allocate resources to design, implement, and maintain a compliance program specific to our U.S. and non-U.S. activities. Additionally, our dedication to providing its life-saving dialysis products to patients and sufferers of ESRD extends worldwide, including conducting humanitarian-related business with distributors in Iran in compliance with applicable law. In particular, our product sales to Iran from Germany are not subject to the EU’s restrictive measures against Iran established by Council Regulation (EU) No. 267/2012 of March 23, 2012, as last amended by Council Implementing Regulation (EU) 2025/1559 of July 25, 2025 implementing Regulation (EU) No 267/2012 concerning restrictive measures against Iran, as the Company’s products sold to Iran do not fall within the scope of the EU sanctions and none of the end users or any other person or organization involved is listed on the relevant EU sanctions lists. Because our sales to Iran were and are made solely by our German subsidiaries, the sales are not subject to the Iranian Transactions and Sanctions Regulations, 31 C.F.R Part 560 (ITSR) and are not eligible for licenses from the U.S. Treasury Department’s Office of Foreign Assets Control (OFAC) pursuant to the Trade Sanctions Reform and Export Enhancement Act of 2000. Also, ITSR § 560.215(a) is not applicable in the present case because we do not have a U.S. parent company and are not in any other way owned or controlled by a U.S. person, as those terms are used in ITSR § 560.215(a), and our affiliates involved in Iran-related transactions are also not “owned or controlled” by a U.S. person. That we have a U.S. subsidiary does not cause the ITSR to apply to our Iran-related transactions (because the sales by our non-U.S. affiliates are outside the scope of ITSR §560.215(a)). In any case, OFAC’s public guidance provides that sales of medical devices to Iran by non-U.S. companies are generally subject to humanitarian exceptions under U.S. sanctions targeting Iran. During the year ended December 31, 2025, we sold approximately €11.8 M of dialysis products to an independent distributor. This distributor further distributes the products to other foreign distributors for resale, processing, and assembling in Iran. The products included fiber bundles, dialysis concentrates, dialysis machines, parts, and related disposable supplies. The sales of these products generated approximately €6.8 M in operating income for the year ended December 31, 2025. All such sales were made by our German subsidiaries. Based on information available to us, we believe that most products were eventually sold to hospitals in Iran through state purchasing organizations affiliated with the Iranian Ministry of Health and were therefore sales to the “Government of Iran” as defined in ITSR § 560.304. Our 2025 sales to Iran represent approximately 0.06% of our total revenues. We have no subsidiaries, affiliates, or offices, nor do we have any direct investment or own any assets, in Iran. In light of the humanitarian nature of our products and the patient communities that benefit from our products, we expect to continue selling dialysis products to Iran, provided such sales continue to be permissible under, or excluded from, applicable export control and economic sanctions laws and regulations. Patient, physician and other relationships We believe that our success in establishing and maintaining healthcare centers, both in the U.S. and in other countries, depends significantly on our ability to obtain the acceptance of and referrals from local physicians, hospitals, and integrated care organizations. Our ability to provide high-quality dialysis care and to fulfill the requirements of patients and doctors depends significantly on our ability to enlist nephrologists as medical directors for our dialysis clinics and receive referrals from nephrologists, hospitals, post-acute care facilities, and general practitioners. Medicare program regulations rely on Conditions for Coverage rules for ESRD facilities which require that each dialysis clinic shall have a medical director who is responsible for overseeing the delivery of patient care and outcomes at the dialysis clinic. The medical director must be board-certified or board eligible in internal medicine or pediatrics, have completed a board-approved training program in nephrology, and have at least twelve months of experience providing care to patients undergoing dialysis. We have engaged physicians or physician practices to serve as medical directors for our outpatient dialysis centers, home dialysis programs, and inpatient dialysis service relationships with hospitals. The compensation of our medical directors and other contracted physicians is negotiated individually in arm’s length negotiations and is based on the anticipated workload for each clinic or program the medical director will oversee, as well as any unique market factors such as, for example, the lack of availability of alternative options within the market. The total annual compensation of the medical directors is to be in place for a term of at least one year and the medical directors agree to seek to continue to improve quality, safety, and efficiency. We have developed internal processes with the goal of setting the compensation of our medical directors at fair market value. Almost all contracts we enter into with our medical directors in the U.S., as well as the typical contracts which we obtain when acquiring existing clinics, contain non-compete clauses concerning certain activities in defined areas for a defined period of time. These non-compete agreements restrict the physicians from owning or providing medical director services to other outpatient dialysis centers, but these clauses do not restrict the physicians from performing patient services directly at other locations/areas or referring patients to other facilities. We do not require physicians to send patients to us or to specific clinics. 40 Table of Contents In addition to our dialysis clinics, a number of our other healthcare centers employ or contract with physicians to provide professional and administrative services. We have financial relationships with these physicians in the form of compensation arrangements for the services rendered. We have processes in place to negotiate these contractual arrangements in compliance with federal and state laws applicable to financial relationships with physicians, such as the Stark Law and the Anti-Kickback Statute. A number of the dialysis clinics and other healthcare centers we operate are owned or managed by entities in which we hold a controlling interest and one or more hospitals, physicians, or physician practice groups hold a minority interest. We have granted holders of these minority interests put options or similar rights under which we could be required to purchase all or part of the minority owners’ noncontrolling interests. See notes 1 a) and 26 of the notes to our audited consolidated financial statements included in this report. We also have agreements with physicians to provide management and administrative services at healthcare centers in which physicians or physician groups hold an ownership interest and agreements with physicians to provide professional services at such healthcare centers. Our relationships with physicians and other referral sources relating to these entities must comply with the federal Anti-Kickback Statute and Stark Law. There is a safe harbor under the Anti-Kickback Statute for certain investment interests in small entities. Investments by physicians and other referral sources in these entities have been designed to comply with the federal Anti-Kickback Statute and Stark Law, but they do not satisfy all of the requirements for safe harbor protection under the Anti-Kickback Statute. Failure to comply with a safe harbor does not render an arrangement illegal under the federal Anti-Kickback Statute and, therefore, physician-owned entities that fall outside the safe harbors are not, by definition, prohibited by law but continue to be subject to legal scrutiny. Our contractual and other relationships with physicians and other referral sources are subject to numerous legal requirements. While we operate under procedures and policies regarding compliance with these requirements, and in some respects, we follow the guidance under safe harbors, there is no assurance that our interpretations of legal requirements will always be accurate or that our execution of legal requirements will always be sufficient or complete. We have received civil investigative demands from the U.S. Federal Trade Commission (FTC), the Florida Attorney General, and the Washington Attorney General requesting information regarding our conduct in acquiring medical director services and providing dialysis service, including information related to restrictive covenants such as non-competes with physicians. For further information, see Item 3.D, “Key information — Risk factors” and note 25 of the notes to our audited consolidated financial statements included in this report. Capital expenditures We invested, by operating segment, the gross amounts shown in the table below during the years ended December 31, 2025, 2024, and 2023. ​ ​ ​ ​ ​ ​ ​ ​ Capital expenditures (gross) ​ ​ ​ ​ ​ ​ in € M ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ 2023 Capital expenditures for property, plant and equipment and capitalized development costs ​ ​ ​ Care Delivery 323 355 332 Value-Based Care 0 1 1 Care Enablement 592 343 352 Total 915 699 685 ​ ​ ​ ​ ​ ​ ​ Acquisitions, investments, purchases of intangible assets and investments in debt securities ​ ​ ​ Care Delivery 50 35 55 Value-Based Care 0 2 0 Care Enablement 60 68 83 Total 110 105 138 ​ For additional information regarding our capital expenditures, see Item 5.IV, “Operating and financial review and prospects — Financial position.” 41 Table of Contents Acquisitions and investments A significant factor in the growth in our revenue and operating earnings in prior years has been our ability to acquire healthcare businesses, particularly dialysis clinics, on mutually beneficial terms. In the U.S., physicians and others who own dialysis operations might decide to sell their clinics (or investment interests in their clinics) to obtain relief from day-to-day administrative responsibilities and changing governmental regulations, to focus on patient care, and to realize a return on their investment. Outside the U.S., doctors might determine to sell to us and/or enter into certain relationships with us to achieve the same goals and to gain a partner with extensive expertise in dialysis products and services. Privatization of healthcare in Eastern Europe and Asia could present additional acquisition opportunities. We believe we are also viewed as a valuable strategic healthcare partner outside the dialysis business due to our experience in managing chronic disease for dialysis patients, our record of improving quality and patient satisfaction, reducing the overall cost of care, and our leadership in advancing innovation and improvement in healthcare. For a discussion of our 2025, 2024, and 2023 acquisitions and investments, see Item 5, “Operating and financial review and prospects — IV. Financial position — Net cash provided by (used in) investing activities.” Production We operate modern development, production, and distribution facilities worldwide to meet the demand for our dialysis products and other healthcare products. We have invested significantly in developing proprietary processes, technologies, and manufacturing equipment resulting in a competitive advantage in manufacturing our products. Production facilities and distribution centers are located around the world, with many strategically positioned to reduce transportation cost and facilitate the distribution of products to our customers. The following table describes the countries in which we produce, manufacture or assemble products globally: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Production overview by country ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Home ​ ​ ​ ​ Peritoneal ​ ​ ​ ​ ​ ​ ​ hemodialysis ​ ​ Hemodialysis ​ dialysis ​ ​ ​ Polysulfone ​ ​ ​ products and ​ ​ machines ​ cyclers ​ Dialyzers ​ membranes ​ Bloodlines components China ​ ​ ​ ü ​ ​ ​ ​ ​ ​ ​ ü ​ ​ ​ ​ ​ ​ ​ ü ​ ​ ​ ​ France ​ ​ ü ü ​ ​ Germany ü ü ü ü ​ ü Italy ​ ​ ​ ​ ​ ü Japan ​ ​ ü ü ​ ​ Mexico ü ü ​ ​ ü ü Serbia ​ ​ ​ ​ ü ​ Türkiye ​ ​ ​ ​ ü ​ U.S. ​ ​ ü ü ​ ​ ​ In addition, we manufacture hemodialysis concentrate products and PD solutions at various facilities worldwide. Procurement We manage the procurement of raw materials and semi-finished goods used in the manufacturing of renal products globally. This global approach enables us to: ● enhance the efficiency of our processes, ● optimize cost structures, ● improve returns on our capital invested in manufacturing, ● respond quickly, ● maintain high quality and safety standards, and ● lessen risks in our supply chain to ensure supply availability. 42 Table of Contents Our procurement risk mitigation efforts include the development of partnerships with strategic suppliers through framework contracts, maintaining, where reasonably practicable, at least two sources for all supply and price-critical primary products (dual sourcing, multiple sourcing), incorporating measures to prevent loss of suppliers such as continuous supply chain monitoring, and the creation of risk mitigation strategies to increase supply chain resilience, particularly for primary and secondary suppliers located in countries with unpredictable geopolitical landscapes. Our procurement policy combines worldwide sourcing of high-quality materials with the establishment of long-term supplier relationships. Additionally, we have processes in place to ensure that purchased materials comply with the quality specifications and safety standards required for our dialysis products. We outsource only after we have qualified suppliers, ensuring they meet our requirements. Interactive supplier relationship management and risk management systems connect all our global procurement activities to enhance global transparency, ensure compliance with our Global Code of Conduct for Business Partners, standardize processes, and enable the constant monitoring of our projects and supplier-related activities. With close to €8.0 BN of addressable spend per year purchased from over 70,000 external suppliers, procurement is a function having a significant operational and financial impact on the Company. Effective January 1, 2025, ProCure Medical GmbH (PMG), our subsidiary, commenced operations as our global procurement company. PMG focuses on global category management, strategic sourcing, and supplier partnering in spend areas that we believe provide opportunities to capture incremental value through leveraging our procurement scale and skills above the country and regional levels. Overall, we anticipate that PMG will strengthen procurement’s strategic role within the Company and sharpen alignment with the goals and ambitions of the FME25+ Program. Quality assurance and quality management in dialysis care With a focus on quality, costs and availability, we introduced an improved organizational infrastructure with efficient processes and systems over the last several years. All production sites follow the Lean Manufacturing approach which, in our plants in North America and most of our plants in the European, Middle East and African regions, includes the “Lean Six Sigma” management system. The focus of Lean Manufacturing and Six Sigma is the continuous improvement of manufacturing processes in order to achieve a low defect rate resulting in improved product quality, while reducing manufacturing time. Our production of renal pharmaceuticals and medical devices must comply with current Good Manufacturing Practices under the applicable regulations of the U.S. FDA, the EU, the Brazilian Health Regulatory Agency (ANVISA) and other jurisdictions. See “— Regulatory and legal matters — Product Regulation,” below. We have been successful in the continued harmonization of the major management systems in all manufacturing and development sites outside the U.S., the International Organization for Standardization (ISO)-certified marketing and sales sites in the EMEA region and the EU legal manufacturer under one globally harmonized management system (GMS). The GMS fulfills ISO 13485:2016, ISO 9001:2015 and ISO 14001 standards, the Medical Device Single Audit Program (MDSAP) underlying regulatory requirements, the Medical Device Directive 93/42/EEC as well as Regulation (EU) 2017/745 of April 5, 2017 on MDR, which have been implemented in the design, manufacture and distribution sites outside the U.S. (See also “Regulatory and Legal Matters — Facilities and Operational Regulation” below). Every medical device plant outside the U.S. has a local quality management system (QMS) directed by GMS that is certified either to ISO 13485:2016 and/or ISO 9001:2015 under MDSAP. Our operations in the U.S. continue to be governed under our North American Management System in compliance with U.S. FDA regulations. Where applicable, each site also complies to the Medical Device Directive 93/42/EEC, the MDSAP underlying regulatory requirements and additional national requirements based upon target markets and countries of manufacturing. Plants producing products with the Conformité Européene mark are in compliance with the EU MDR and our product portfolio is in the transition process to obtain EU MDR conformity in line with legal timelines until May 2028. The QMS of each site is reviewed through periodic corporate and local management reviews as well as internal audits. All certified plants have successfully passed the annual ISO 13485, ISO 9001, MDSAP underlying regulatory requirements, external QMS audits and authority inspections for maintaining their required certifications and licenses. Our dialysis clinics work in conformance with the generally accepted quality standards of the industry, particularly the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines from the U.S., the European Renal Best Practice standard and increasingly, Kidney Disease: Improving Global Outcomes (KDIGO), an industry initiative for global clinical practice guidelines. Clinical data management systems are used to routinely collect certain medical parameters, which we evaluate in anonymized form in compliance with these guidelines. 43 Table of Contents At each of our dialysis clinics in the U.S., a quality assurance committee is responsible for reviewing quality of care data, choosing local quality improvement projects and monitoring the progress towards achieving the quality targets which are informed by KDOQI, KDIGO and the Quality Agenda established by the Fresenius Medical Care North America (FMCNA) Medical Office. A rigorous scoring system, Clinical Quality Score, reports trends in outcomes and performance comparison among all levels of the organization. Visual representation of key performance indicators can be viewed in increasing levels of detail to provide transparency of results. We continue to develop and implement programs and tools to assist in achieving our quality goals. These include treatment algorithms based on best medical evidence, outlier management teams, and technology to highlight opportunities for improvement at the dialysis chairside. The Medicare Improvements for Patients and Providers Act of 2008 created the ESRD quality incentive program under which dialysis facilities in the U.S. that fail to achieve annual quality standards established by CMS could have base payments reduced in a subsequent year by up to 2%. These programs blend the CMS quality standard measures with industry baselines in an effort to improve quality of care through a pay-for-performance program that operates as a part of the ESRD PPS. See Item 5. “Operating and financial review and prospects — II. Financial condition and results of operations — Overview.” Outside the U.S., the Care Delivery International (CDI) Clinic Quality Management Department (CQM) is responsible for establishing and maintaining our internal quality management systems in the EMEA and Asia Pacific (APAC) regions. Currently established QMS play a critical role in meeting quality and safety, legal and normative requirements in country organizations and dialysis clinics. As the dialysis industry-related requirements are highly regulated in the EMEA region, the establishment and maintenance of a quality management system is a mandatory requirement to maintain the validity of clinic licenses. CDI QMS performs its scoping procedures according to local legal requirements and Company requirements across EMEA and APAC. As such, both CDI CQM and country quality managers share responsibilities for defining, controlling and mitigating the quality, safety and clinical risks during the audit process as well as ensuring a continuously improving system. The CDI QMS audit program is performed at both the country and clinic level by systems, environmental, health and safety, nursing and medical expert auditors. The audit program has a non-conformity rating strategy focusing on risk assessment and, by utilizing regular audits, our clinical compliance status can be monitored regularly. We use different tools and systems together with CDI QMS to monitor our compliance status and performance of countries and clinics, including performance management tools such as balanced scorecards. In EMEA and APAC, respectively, 601 and 125 dialysis centers clinical and operational performance are measured via the CDI Balanced Scorecard. We also utilize a Power BI tool to monitor non-conformities and respective corrective actions by all levels of the organization. Additionally, regular management and operational review meetings are held at both corporate and country levels to address and respond to risks. Specific to our Value-Based Care operating segment, we partner with payors, the Centers for Medicare and Medicaid Innovation (CMMI), nephrology practices, dialysis clinics, and transplant providers across the U.S. to help improve efficiency, health outcomes, and quality of care for aligned CKD and ESRD patients. Performance in each contract is measured by our ability to meet specific quality metrics, such as optimal starts, patient engagement, and delaying disease progression, as well as our ability to lower the total cost of care, through deploying care management tactics that help avoid hospitalizations and ensure that patients are receiving timely, holistic care and are appropriately connected to a nephrologist. To monitor our progress in meeting Value-Based Care contract performance and quality savings goals, our Value-Based Care segment aligns its company sub-goals to patient outcomes and quality improvement. These sub-goals are routinely assessed and evaluated by all levels of the Company, ensuring Value-Based Care’s focus remains on delivering quality outcomes for patients that lower the total cost of care. In addition, Value-Based Care also uses tactics such as call monitoring, patient surveys and feedback, and data science to monitor and improve the quality of care provided throughout the year as well. Environmental management Environmental management in the healthcare sector involves balancing environmental responsibility with high-quality patient care. Providing patient care and the manufacturing of our life-sustaining products require significant amounts of energy, water, and other resources. We develop strategies that minimize environmental impact while maintaining safety and efficiency. To verify compliance with environmental laws, local regulations, certifications, and internal guidelines, our production sites, distribution centers, laboratories, and dialysis clinics undergo both internal and external audits. Our employees are kept informed about environmental topics through internal articles, workshops, Q&A sessions, and targeted training. The Management Board oversees strategic environmental matters, including the approval of the overarching environmental strategy and global targets. It supervises global environmental policies and receives updates from the Global Head of Sustainability on the implementation of measures and progress toward global targets throughout the year. The Management Board, relevant business units, and global functions support resource allocation, and identify, prepare, and implement sustainability projects at all levels. The Supervisory Board also receives updates during the year on implementation and progress related to the environment. 44 Table of Contents In recent years, there have been price increases and volatility in energy markets that could impact our financial position, for example, through the impact of vPPAs. While energy risks can be managed, they cannot be entirely eliminated, especially given potential supply challenges. Additionally, growing regulatory and market pressures may require a faster transition to renewable energy sources, potentially driving up operational costs. Generating and procuring renewable electricity in the markets where we operate can lead to cost savings, positive cash flows, and operational improvements. Examples include vPPAs, extending energy efficiency projects, and replacing energy sources, such as transitioning from gas to electricity. As a global healthcare company with production sites and clinics worldwide, we could be subject to potential physical risks posed by climate change. These may include floods, storms, heatwaves, droughts, and water stress, which could disrupt operations, affect infrastructure, and impact service continuity. We continue to evaluate the potential financial impact of transition scenarios on our assets and our business model. We anticipate being able to secure access to financing, retain options for asset deployment flexibility, adapt our product and service offerings as market conditions evolve, and develop workforce capabilities aligned with climate transition requirements. This assessment is based on professional judgment, considering our climate targets, including actions such as our renewable electricity purchasing strategy, water strategy, and our forward-looking environmental risks management. We generate and source renewable electricity in the markets where we operate. This can lower costs and improve cash flow. In 2024, we entered into five vPPAs, which are long-term purchase agreements with wind and solar parks. Three sites started producing electricity in 2024. Since January 2025, all sites have been operational and supplied electricity for the entire year. The contracts have terms ranging from 10 to 15 years. For further information regarding the impact of vPPAs on our consolidated financial statements, see note 26 of the notes to the consolidated financial statements included in this report. In 2025, our Management Board extended our climate targets to include a net-zero goal, which has been validated by the Science Based Targets initiative (SBTi). Alongside existing climate targets, we now aim to achieve net-zero across our entire value chain by 2050, based on SBTi criteria. According to our validated net-zero target, we need to reduce our combined scope 1 and market-based scope 2 emissions, as well as our combined scope 3 emissions, by 90% compared to their respective base years by latest 2050. In addition to the long-term target noted above, we have also established near-term and interim targets. By 2030, we plan to reduce our scope 1 and 2 emissions by 50% (457,866 tCO2e) compared to our 2020 base year (915,732 tCO2e) across our global operations. We have set two near-term scope 3 targets, covering six scope 3 categories and over 72.5% of total scope 3 emissions. With the first target we aim to reduce our combined scope 3 emissions from the following three categories by 25% compared to our scope 3 baseline year 2024: fuel- and energy-related activities, business travel, and use of sold products. As a second target, we have set a supplier engagement target to actively involve suppliers in reducing their scope 1 and 2 emissions. We expect the suppliers responsible for 70% of our scope 3 emissions in the three categories – purchased goods and services, capital goods, and upstream transportation and distribution – to set science-based emission reduction targets. Our target covers 1,206,929 tCO2e from these categories (around 39% of scope 3 emissions). In 2025, we verified that 11% of emissions in these categories were covered by suppliers that have set SBTi targets. We remain committed to our more ambitious scope 1 and 2 target established in 2022. We aim to achieve a 90% reduction of our combined scope 1 and market-based scope 2 emissions by 2040 and expect to meet the SBTi validated target ten years in advance. Management Board and managerial staff member compensation has also been directly linked to our emissions targets and its effect on our financial statements is described in note 23 of the notes to the consolidated financial statements included in this report. Management Board compensation is also described in Item 6.B, “Directors, senior management and employees — Compensation,” below. In 2025, our scope 1 and 2 emissions totaled 649,608 tCO2e (2024: 687,439 tCO2e), a reduction of over 29% from our baseline (annual average reduction of 5.8% since 2020). Scope 1 emissions increased by 1.2% and market-based scope 2 emissions decreased by 12.9%. This decrease is mainly due to renewable electricity from our vPPAs. In 2025, the scope 3 emissions covered by our emissions reduction target increased by around 3% compared to our baseline. This is the result of increased sales and the resulting emissions from the use of sold products. Patents and patent licenses As the owner of patents or licensee under patents throughout the world, we currently hold rights in over 7,800 patents and patent applications in major markets. Technologies that are the subject of granted patents or pending patent applications include aspects of our hemodialysis, peritoneal dialysis, and critical care treatment systems, relating to both single-use products and treatment machines. 45 Table of Contents Other parts of the patent portfolio relate to platform and future technologies, such as digital and data management. We believe that our success will continue to depend significantly on our technology. As a standard practice, we obtain the legal protections we believe are appropriate for our intellectual property. Nevertheless, we are in a position to successfully market a significant number of products for which patent protection has lapsed or where only particular features are patented. We believe that even after the expiration of some of our patents, our proprietary know how for the manufacturing of our products and our continuous efforts to obtain targeted patent protection for newly developed upgraded products will continue to provide us with a competitive advantage. From time to time, our patents may be infringed by third parties and, in such cases, we will assert and enforce our rights. Registered patents may also be subject to invalidation claims made by competitors in formal proceedings (oppositions, trials, re-examinations, invalidation action, etc.) either in part or in whole. In addition, technological developments could suddenly and unexpectedly reduce the value of some of our existing intellectual property (see Item 3.D, “Key Information – Risk Factors”). Trademarks As the owner of trademarks or licensee of trademarks throughout the world, we currently hold rights in over 3,600 registered trademarks or trademark applications covering inter alia our key product branding in major markets. Our principal trademarks and corporate names are or comprise the designation “Fresenius Medical Care” which we use stand-alone or together with the V-shaped design element (the FME super-sign) in our corporate logo. The use of the “Fresenius” name in our trademarks and corporate logo is based on a perpetual, royalty-free license from Fresenius SE, our major shareholder. The original Trademark License Agreement dated September 27, 1996 (Original Trademark License Agreement) remains in force after our Conversion and related deconsolidation from Fresenius SE as amended by the Long Form of Amendment to the Original Trademark License Agreement dated December 23, 2025 (Trademark License Agreement). The amended scope of the rights to use the Licensed Marks and/or the “Fresenius” name in the Worldwide Territory for products and/or services in different business fields shall only be governed by the Trademark License Agreement and reflects the current scope of business of Fresenius SE and the Company. Other amendments/clarifications concern, inter alia, standards regarding the use of the “Fresenius” name (details to be defined in Branding Guidelines, jointly developed by Fresenius SE and the Company), limits on the current and future stand-alone use of the “Fresenius” name by us, the introduction of customary termination rights and the introduction of reporting obligations regarding any harmful use of the Licensed Marks and/or of “Fresenius” name. See Item 7.B, “Related party transactions — Trademarks.” The Trademark License Agreement has been filed as an exhibit to this report. Risk management We see risk management as the ongoing task of determining, analyzing and evaluating the spectrum of actual and potential risks arising from our business operations in our environment and, where possible, taking preemptive and corrective measures. Our risk management system provides us with a basis for these activities. It enables management to identify risks that could jeopardize the achievement of our strategic objectives or going concern and to take steps to minimize any negative impact. Accordingly, it is a vital component of our management and governance. Risk management system The main objective of the risk management system is to identify potential risks as early as possible to assess their impact on business activities and enable us, where necessary, to take appropriate countermeasures. Due to the constantly changing external and internal environment, our risk management system is continuously evolving. In the past fiscal year, we expanded our enterprise risk management system to include new functions and segments. In addition, we developed a new training concept to further improve the effectiveness and outcomes of the enterprise risk management system. 46 Table of Contents The organizational structure of our corporate risk management as well as the processes described below are shown in the following overview: ​ ​ The structure of the risk management system is based on the internationally recognized framework for company-wide risk management, the “Enterprise Risk Management - Integrated Framework” of the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Additionally, sustainability-related risk management is part of our risk management system. As part of the risk management system, risk coordinators, utilizing risk management software, assume the task of coordinating risk management activities within our risk management segments, in particular for risk identification and assessment with individual risk owners by means of, among other things, workshops, interviews and queries. These activities relate to existing and potential emerging short-term as well as mid-term risks. Semi-annually, identified risk information is processed by the risk coordinators and reviewed by the respective heads of general and administrative (G&A) functions, which is followed by further discussion and review in risk committees. Subsequently, the corporate risk management function gathers the risks and risk responses from risk management segments, analyzes and discusses them in the corporate risk committee, and communicates the compiled results to the Management Board. The analysis of the risk situation also includes determining the degree of a potential threat to our going concern by aggregating all risks with the aid of a software-supported risk simulation. The Management Board and corporate risk management are promptly informed of new risks that are estimated to be high or develop into high risks in order to ensure appropriate responses (see Item 5. “Operating and financial review and prospects — VI. Risk matrix” regarding the classification of risks). The effectiveness of the risk management system is monitored by the Audit Committee of the Supervisory Board which also receives risk reporting information. Finally, the Supervisory Board is also informed about the risk situation. In addition to risk reporting, standard reporting to management is a crucial tool for managing and controlling risks as well as for taking preventive measures in a timely manner. Therefore, our Management Board is informed monthly about the industry situation, our operating and non-operating business, and the outcome of analyses of our earnings and financial position, as well as of our assets position on a quarterly basis. 47 Table of Contents The Global Internal Audit department is regularly informed about the results of the risk management system. This department determines risk focus areas and audits a selected number of our end-to-end processes, management systems, departments, subsidiaries, and information technology (IT) processes worldwide each year. Determined risk focus areas are audited across all business segments. The department works according to the internationally accepted standards of the Institute of Internal Auditors, which was confirmed by a quality assessment in 2022. The next quality assessment is planned for 2026, based on the revised standards of the Institute of Internal Auditors. The scope of individual audit engagements is risk-focused and involves, among other activities, periodic assessment of the effectiveness of controls (including legal and compliance controls) over business processes, IT security, the reliability of financial reporting, and compliance with accounting regulations and internal policies. Since 2021, Global Internal Audit has conducted third-party audits of selected sales intermediaries to give assurance that business transactions with our products are in accordance with applicable compliance standards. The “objects” to be audited are determined annually based on an audit universe, i.e. a selection model taking various risks and materiality into consideration. This annual audit plan is reviewed and approved by the Management Board and the Audit Committee of the Supervisory Board. All audit reports with material observations are presented to the Management Board. The Global Internal Audit department is also responsible for monitoring the implementation of measures mitigating identified deficiencies. The Management Board is informed about the mitigation status on a quarterly basis. The Audit Committee of the Supervisory Board is also informed of the audit results. In 2025, a total of 24 audits and 15 sales intermediary audits conducted. Risk focus areas were compliance, FCPA, governance and ESG. Nevertheless, it is important to note that a functioning and adequate risk management system cannot guarantee that all risks are fully identified and controlled. For information regarding our risk management processes relating to environmental matters, including climate change, see “— Environmental Management” above. For information regarding our risk management processes relating to cybersecurity, see Item 16K, “Cybersecurity” in this report. Internal control and risk management system for the Company’s accounting process Our internal control system over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of our financial statements for external reporting purposes in accordance with IFRS Accounting Standards as issued by the International Accounting Standards Board (IASB). Our reporting process is designed for reliable recording, processing, and control of financial data and key disclosures. In addition, the Management Board and the departments responsible for preparing the consolidated financial statements discuss key parameters, assumptions, and estimates that substantially affect the externally reported consolidated and segment results. The Audit Committee of the Supervisory Board also reviews current quarterly results and compares them with budgets and projections. The internal control system contains guidelines and instructions designed for the appropriate and accurate recording and presentation of Company transactions within financial reporting. Further control mechanisms aimed at achieving reliable financial reporting and correct recording of transactions within the accounting and the consolidation process include automated and manual reconciliations as well as the organizational separation of certain functions to prevent potential conflicts of interest. Furthermore, several preventive approval steps as well as detective plausibility checks are in place in various core finance and finance-related processes to ensure correct financial reporting. All process owners identify and assess the risks of their respective processes in terms of the implications for accounting and financial reporting. These process owners also determine that corresponding controls are in place to minimize these risks. Changes to accounting standards are discussed on an ongoing basis and considered in the preparation of the financial statements. Employees responsible for financial reporting are provided with regular training regarding changes in accounting standards. The consolidation is performed by a central department. The basis for the consolidation is derived from reporting packages and sub-group consolidated financial statements prepared and submitted by group entities. The preparation of reporting packages and sub-group consolidated financial statements is performed according to central requirements and guidelines. 48 Table of Contents As we are also listed on the NYSE, we are required to adhere to the requirements of the U.S. Sarbanes-Oxley Act of 2002 (SOX). Section 404 of this federal law stipulates that management of companies listed in the U.S. are responsible for implementing and adhering to an effective internal control system to produce reliable financial reporting. Yearly risk assessment and scoping take place to determine entities, processes, and controls which are subject to SOX requirements. The design and operating effectiveness of the internal control system over financial reporting are routinely assessed and considered in the regular testing cycle. Control testing results are regularly discussed with the respective stakeholders and remediation of control deficiencies is monitored. These criteria are also included in the annual audit by our independent registered public accounting firm. A quarterly certification process has been implemented as a formal accountability and responsibility mechanism for countries, segments, shared services centers, and corporate entities which aims at the accuracy of financial reporting and the associated disclosure controls and procedures. The internal control system over financial reporting follows the criteria of the COSO model, Internal Control – Integrated Framework (2013), which was developed by COSO and is recognized as a standard by the SEC. In accordance with the COSO model, the internal control system over financial reporting is divided into five components: control environment, risk assessment, control activities, information and communication, and the monitoring of the internal control system. Each of these components is regularly documented, tested, and assessed. We aligned our internal controls to fulfill the requirements of the COSO model. Our internal review of the internal control system over financial reporting complies with a specific SEC guideline (Guidance Regarding Management’s Report on Internal Control Over Financial Reporting) and is conducted with software support. The global internal control team coordinates the assessment of the controls in scope for assessment, after which the results are consolidated for information and communication to those charged with governance. Based upon this assessment, management evaluates the effectiveness of the internal control system for the current fiscal year. External advisors are consulted for the review as needed. A steering committee meets at least twice per year to review regulatory developments and changes of relevant internal control requirements, to discuss control deficiencies, and derive further measures. In addition, in its meetings, the Audit Committee of the Supervisory Board is informed regularly of the key results of management’s assessment. Internal control systems over financial reporting are subject to inherent limitations, irrespective of how carefully these systems are designed. As a result, there is no absolute assurance that objectives for financial reporting can be met, nor that misstatements will always be prevented or detected. For further information on these requirements, limitations and management’s assessment of the Company’s internal control over financial reporting for 2025, see Items 15.A. and 15.B, “Disclosure controls and procedures” and “Management’s annual report on internal control over financial reporting.” Regulatory and legal matters Regulatory and compliance overview Our operations are subject to extensive governmental regulation by virtually every country in which we operate including, most notably, in the U.S., at the federal, state and local levels. Although these regulations differ from country to country, in general, non-U.S. regulations are designed to accomplish the same objectives as U.S. regulations governing the operation of healthcare centers, laboratories and manufacturing facilities for healthcare products, the provision of high quality healthcare for patients, compliance with labor and employment laws, the maintenance of occupational, health, safety and environmental standards and the provision of accurate reporting and billing for payments and/or reimbursement. In the U.S., some states establish regulatory processes that must be satisfied prior to the establishment of new healthcare centers. Outside the U.S., each country has its own payment and reimbursement rules and procedures, and some countries prohibit private ownership of healthcare providers or establish other regulatory barriers to direct ownership by foreign companies. Any of the following matters could have a material adverse effect on our business, financial condition, and results of operations: ● failure to receive required licenses, certifications, clearances or other approvals for new or existing services, facilities, or products or significant delays in such receipt; ● complete or partial loss of various certifications, licenses, or other permits required under governmental authority by withdrawal, revocation, suspension, or termination or restrictions of such certificates and licenses by the imposition of additional requirements or conditions, or the initiation of proceedings possibly leading to such restrictions or the partial or complete loss of the required certificates, licenses or permits; 49 Table of Contents ● recoupment or required refunding of payments received from government and private payors as well as government healthcare program beneficiaries because of any failures to meet applicable requirements; ● a non-appealable finding of material violations of applicable healthcare or other laws; and ● changes resulting from healthcare reform or other government actions that restrict our operations, reduce reimbursement or reduce or eliminate coverage for particular products or services we provide. We must comply with all U.S., German and other legal and regulatory requirements under which we operate, including the U.S. federal Medicare and Medicaid Fraud and Abuse Amendments of 1977, as amended, generally referred to as the “Anti-Kickback Statute,” the federal False Claims Act, the federal Physician Self-Referral Law, commonly known as the “Stark Law,” the U.S. Civil Monetary Penalties Law, including the prohibition on inducements to patients to select a particular healthcare provider and the federal FCPA, as well as other fraud and abuse laws and similar state statutes, as well as similar laws in other countries. As a global healthcare company, we are subject to laws and regulations including privacy and data protection. These laws and regulations govern, amongst other elements, the collection, use, disclosure, retention, and transfer of personal data. For example, the EU’s General Data Protection Regulation, which became effective in May 2018, imposes substantial worldwide obligations on the processing and disclosure of personal data. Additional requirements are imposed by U.S. federal rules protecting the privacy and security of patient medical information, as promulgated under the Health Insurance Portability and Accountability Act of 1996 and, as amended by the Health Information Technology for Economic and Clinical Health Act (enacted as part of the American Recovery and Reinvestment Act of 2009), among other rules promulgated by individual state legislatures. These laws continue to develop globally and differ from jurisdiction to jurisdiction, which increases the complexity and costs of our global data protection and security compliance programs. Because of varying legal requirements across the world, the Fresenius Medical Care Global Privacy Foundation (the Foundation) establishes a set of requirements to help ensure appropriate use of personal data throughout its life cycle. While the Foundation creates a baseline compliance requirement for all of our subsidiaries and personnel, we are also obligated to comply with the requirements of all applicable local laws that impose other or stricter standards. A number of U.S. states in which we operate have laws that prohibit business entities, such as the Company and our subsidiaries, from practicing medicine, employing physicians to practice medicine or exercising control over medical decisions by physicians (known collectively as the corporate practice of medicine prohibition). These states also prohibit entities from engaging in certain arrangements, such as fee-splitting, with physicians. Additional state and local laws and regulations require us to maintain certain licenses and certifications to operate our facilities and/or manufacture and distribute our products and services. Our merger and acquisition activity, as well our business operations in both products and services, are regulated by antitrust and competition laws in the countries and localities in which we operate. Some of our transactions are subject to prior review and clearance by competition authorities, while others do not require any such review or clearance. Violations of competition laws may result in government enforcement action as well as private lawsuits. We develop and execute strategies in conformity with these laws to drive innovation and appropriate competition in our businesses and we provide regular internal training on appropriate business strategies under the competition laws. In the U.S., a significant number of our patients receive healthcare coverage through federal health care programs, such as Medicare, Medicaid, and the ACA’s individual market exchanges. There can be no assurance that applicable laws, or the regulations thereunder, will not be amended, or that enforcement agencies or the courts will not make interpretations inconsistent with our own, any one of which could have a material adverse effect on our business, reputation, financial condition and operating results. Sanctions for violations of these statutes may include criminal or civil penalties, such as imprisonment, fines or forfeitures, denial of payments, and suspension or exclusion from the Medicare, Medicaid and other federal health programs. In the U.S., some of these laws have been broadly interpreted by a number of courts, and significant government funds and personnel have been devoted to their enforcement because such enforcement has become a high priority for the federal government and some states. We, and the healthcare industry in general, will continue to be subject to extensive federal, state and foreign (i.e., non-U.S.) regulation, the full scope of which cannot be predicted. In addition, the U.S. Congress and federal and state regulatory agencies continue to consider modifications to healthcare laws that may create further restrictions. Proposals to restructure the Medicare program in the direction of a defined contribution, “premium support” model, to shift Medicaid funding to a block grant or per capita arrangement with greater flexibility for the states have previously been proposed and could have significant effects on our businesses. There also continue to be legal challenges to the ACA, and the outcomes and impact of such changes on our business, financial condition, and results of operations are currently impossible to quantify or predict. 50 Table of Contents We maintain a comprehensive worldwide compliance program under the overall supervision of our chief compliance officer. The program includes a compliance staff, a written code of business conduct applicable worldwide and available on our website, training programs, regulatory compliance policies and procedures including corrective action for failure to follow policies, provisions for anonymous reporting of suspected violations of applicable laws or Company policies, and periodic internal audits of our compliance procedures. We operate many facilities throughout the U.S. and other countries in which we do business. In such a widespread, global system, it is often difficult to maintain the desired level of oversight and control over the thousands of individuals employed by many affiliated companies. We rely on our management structure, regulatory and legal resources, and the effective operation of our compliance program to direct, manage and monitor the activities of these employees. If our employees or their agents or subcontractors, deliberately or inadvertently, were to submit inadequate or incorrect billings to any federally-funded healthcare program, or engage in unlawful conduct with physicians or other referral sources or vendors with which we do business, the actions of such persons could subject us and our subsidiaries to liability under the Federal Food, Drug, and Cosmetic Act, Anti-Kickback Statute, the Stark Law, the False Claims Act or the Foreign Corrupt Practices Act, among other laws. See note 25 of the notes to our audited consolidated financial statements included in this report. While we operate under procedures and policies developed in response to the regulatory environment in which we conduct our business, there is no assurance that our interpretations of legal requirements will always be accurate or that our execution of legal requirements will always be sufficient or complete. Any failure to comply with legal requirements could result in repayment obligations, civil and criminal penalties, loss of licenses and certifications required to conduct business, limitations on our operations and greater governmental oversight. Product regulation U.S. pharmaceuticals In the U.S., numerous regulatory bodies, including the FDA and comparable state regulatory agencies impose requirements on certain of our subsidiaries as a manufacturer, distributor and/or a seller of drug products under their respective jurisdictions. Some of the products our subsidiaries manufacture and/or distribute are subject to regulation under the Federal Food, Drug, and Cosmetic Act of 1938, as amended (FDCA) and FDA’s implementing regulations. These products include our peritoneal dialysis and saline solutions, PhosLo® (calcium acetate), Phoslyra® (calcium acetate oral solution), Venofer® (iron sucrose injection, USP), and Velphoro (sucroferric oxyhydroxide). Distribution of PhosLo® and Phoslyra® was discontinued in 2024. Many of these requirements are similar to those for devices, as described below. We are required to register as an establishment with the FDA, submit listings for drug products in commercial distribution and comply with regulatory requirements governing product approvals, drug manufacturing, labelling, promotion, distribution, post market safety reporting and recordkeeping. We are subject to periodic inspections by the FDA and other authorities for compliance with inspections as well as with federal CMS average sales price reporting, medical drug rebate program and other requirements. Our pharmaceutical products must be manufactured in accordance with current Good Manufacturing Practices (cGMP). We are required to provide information to the FDA whenever we become aware of a report of an adverse drug experience associated with the use of one of our drug products that is both serious and unexpected, as defined in FDA regulations and guidance. We are required to notify the FDA of certain product quality issues. In addition, as with the marketing of our medical devices, in order to obtain marketing approval of our drug products, we must satisfy mandatory procedures and safety and efficacy requirements. Furthermore, the FDA prohibits our products division from marketing or promoting our pharmaceutical products in a false or misleading manner and from otherwise misbranding or adulterating them. Finally, if the FDA believes that a company is not in compliance with applicable drug regulations, it has similar enforcement authorities as those discussed below with respect to medical devices, including under the administrative, civil, and criminal penalty provisions of the FDA. Other state and federal regulatory and enforcement agencies have authority to enforce related fraud, consumer protection, privacy, and other laws. Pharmaceuticals outside the U.S. Some of our products, such as peritoneal dialysis and acute dialysis solutions as well as phosphate binders and other orally administered drugs, are considered medicinal products subject to the specific drug law provisions in various countries. The EU has issued several directives and regulations on medicinal products, including a directive on medicinal products for human use, like Regulation (EC) 726/2004 (March 31, 2004) and Directive 2001/83/EC (November 6, 2001), as amended. Each member of the EU is responsible for conforming its law to comply with the latter directive. In Germany, the German Drug Law (Arzneimittelgesetz or AMG), which implements several EU requirements, is the primary regulation applicable to medicinal products. 51 Table of Contents The provisions of the AMG are comparable with the legal standards in all other European Union countries. As in many other countries, the AMG generally provides that a medicinal product may only be placed on the market if it has been granted a corresponding marketing authorization. Such marketing authorization is granted by the licensing authorities only if the quality, efficacy and safety of the medicinal product have been scientifically proven. Medicinal products marketed on the basis of a corresponding marketing authorization are subject to ongoing control by the competent authorities. The marketing authorization may also be subsequently restricted or made subject to specific requirements. The production of medicinal products requires a manufacturing license which is granted by the competent authorities of the relevant EU Member State for a specific manufacturing facility and for specific medicinal products and forms of medicinal products. The manufacturing license is granted only if the manufacturing facility, production techniques and production processes comply with the national drug law requirements, with the principles and guidelines of EU-Good Manufacturing Practice (EU-GMP). International guidelines also govern the manufacture of medicinal products and, in many cases, overlap with national requirements. Material regulations concerning manufacture and registration related to medicinal products have been issued by the European Commission (EC) and the International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The Pharmaceutical Inspection Co-operation Scheme (PIC/S), an international informal cooperative arrangement between regulatory authorities, aims at harmonizing inspection procedures by developing common standards in the field of good manufacturing practices and by providing training opportunities to inspectors. Among other things, the EC, PIC/S and ICH establish requirements for good manufacturing practices, many of which are then adopted at the national level. Another international standard, which is non-binding for medicinal products, is the ISO9001:2015 system for assuring quality management system requirements. This system has a broader platform than EU-GMP, which is more detailed and is primarily acknowledged outside the field of medicinal products, e.g., with respect to medical devices. U.S. medical devices Our subsidiaries engaged in the manufacture of medical devices are required to register with the FDA as device manufacturers and submit listing information for devices in commercial distribution. As a manufacturer of medical devices, we are subject to requirements governing premarket approval and clearance, labelling, promotion, clinical research, medical device adverse event reporting, manufacturing practices, reporting of corrections and removals, and recordkeeping, and we are subject to periodic inspection by the FDA for compliance with these requirements. With respect to manufacturing, we are subject to FDA’s Quality System Regulation (21 C.F.R. Part 820) and related FDA guidance, which requires us to manufacture products in accordance with cGMP, including standards governing product design. The medical device reporting regulations and guidance require that we report to the FDA whenever we receive or become aware of information that reasonably suggests that a device may have caused or contributed to a death or serious injury, or that a device has malfunctioned and a device or similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. FDA regulations also may require us to conduct product recalls and take certain other product corrective actions in response to potential quality issues. In addition, the FDA prohibits our products division from promoting our manufactured products for unapproved or uncleared indications or in a false or misleading manner. We are also prohibited from promoting unapproved or uncleared drugs or devices more generally. Finally, as with our pharmaceutical products, states impose additional requirements on our drug and device manufacturing and distribution activities, including requiring additional state licenses. We are subject to periodic inspections by the FDA and other authorities for compliance with these requirements. In January 2023, SEIU-United Healthcare Workers West, a labor union, submitted a petition requesting that the U.S. FDA issue a recall of certain of our dialysis machines to address certain purported safety matters raised by their petition. The Company believes that the claims raised by the union’s petition are without merit. The FDA has not responded to the petition. If and when the FDA acts on the petition, the Company will respond appropriately. Medical devices outside the U.S. In the European Union, medical devices are subject to their own regulatory requirements. Since May 26, 2021, the Medical Device Regulation (EU) 2017/746 of the European Parliament and of the Council of April 5, 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU have replaced former acts and set out the main regulatory framework. Although the MDR is self-binding in all Member States of the EU, numerous acts of the EC and of national legislation in each Member State are necessary to fully implement the legal provisions. These provisions essentially include higher safety standards to be met by medical devices and, therefore, require a new conformity assessment procedure and re-certification of all medical devices regardless of whether they have already been placed on the market. 52 Table of Contents Originally, the transitional provisions according to Article 120 of the MDR allowed manufacturers until May 2024, at the latest, to continue to place their medical devices on the EU market based on a valid EC certificate according to the former directives and local laws for medical devices. However, on March 15, 2023, the European Parliament published Regulation (EU) 2023/607 (2nd amendment to the MDR), with major relevance for certification and products which are already on the market in compliance with the Medical Devices Directive (MDD). MDD certificates shall be considered valid until end of the new transition dates. We have met all requirements of the 2nd amendment enabling us to continuously place MDD products on the market until December 31, 2027 or December 31, 2028, depending on the specific products’ individual risk class. The corresponding manufacturer’s declaration and confirmation letters by the notified body have been issued accordingly. Conformity of our QMS with the applicable MDR requirements was assessed and confirmed by our notified body during an initial certification audit in 2019 and surveillance audits in 2020 through 2023. During 2024, the MDR recertification audit was successfully passed, followed by the successfully passed surveillance audit in 2025. After the additionally required successful assessment of the submitted technical documentation, the first EU certificate, pursuant to the MDR, was issued mid 2020 by our notified body. For each extension of the product scope of the EU certificate, a review of a sample of the technical documentation from the respective product group is required. Following this step-wise approach, our EU MDR certificates have been extended in 2023, 2024, and 2025, resulting in greater than 97% coverage of those product categories required to certify our product portfolio. In alignment with our product business, one remaining product category is currently in the certification process with our notified body with planned finalization in 2026. According to the current EU regulations, the Conformité Européene mark serves as a general product passport for all Member States of the EU and the European Economic Area (EEA). Upon receipt of an EU certificate for a product according to the applicable conformity assessment procedure, e.g. a certified full quality management system for medical devices according to ISO 13485:2016, and the documented declaration and proof of conformity of our products to the harmonized European norms (Declaration of Conformity), we as the legal manufacturer are able to mark products as being in compliance with the EU requirements. If able to do so, the manufacturer must place a Conformité Européene mark on the products. Medical devices that do not bear the Conformité Européene mark cannot be sold or distributed within the EU. Clinical Research Our subsidiaries engaged in the manufacture and sale of medicinal products and medical devices, when engaged in clinical research involving investigational products, are subject to many requirements governing the conduct of clinical research, including Good Clinical Practice (GCP) standards. Similarly, our subsidiaries involved in the provision of clinical research services may also be subject to those requirements governing the conduct of clinical research depending on the nature of the research involved. FDA and other regulatory bodies’ enforcement action If the FDA or other regulatory bodies believe that a regulated company is not in compliance with applicable laws and regulations, they can pursue various administrative and enforcement actions, including, for example, issuing an untitled or warning letter, initiating a seizure action, or seeking an injunction. Among other things, these actions can result in the assessment of administrative penalties, product recalls and civil or criminal enforcement. Such actions could also lead to additional enforcement by other state or federal government agencies as well as lawsuits by patients or shareholders. On December 4, 2023, the FDA issued a warning letter to us citing several deficiencies of the cGMP requirements of the Quality System regulation and alleging possible corrective and preventive action failures, among other things, in connection with the use of silicone tubing used in certain of our dialysis machines that was previously reported to the FDA. We have responded and continue to update the FDA about continuing remediation efforts. For a description of the status of outstanding FDA warning letters related to our operations, see note 25 of the notes to the consolidated financial statements included in this report. We cannot assure that all necessary regulatory clearances or approvals, including those for new products or product improvements, will be granted on a timely basis, if at all. Delays in or failure to receive clearance or approval or delays in or failures to carry out product recalls may result in liability and reputational harm and may materially adversely affect our operating results. If at any time the FDA or other regulatory bodies believe we are not in compliance with applicable laws and regulations, they could take administrative, civil, or criminal enforcement action, resulting in liability and reputational harm, which could materially affect our operating results. 53 Table of Contents Potential changes impacting our private payors in the U.S. The operation of charitable insurance premium assistance programs such as that offered by the American Kidney Fund (AKF) has received increased attention over the last few years by CMS and state insurance regulators and legislators. The result may be a regulatory framework that differs from the current framework or that varies from state to state. Even in the absence of actions by CMS or state regulators and legislatures to restrict the access that patients currently have to premium assistance programs, insurers are likely to continue efforts to thwart charitable premium assistance by premium assistance programs to our patients. If successful in a material area or scope of our U.S. operations, these efforts would have a material adverse impact on our business and operating results. One such law that was enacted is AB290 in California (U.S.). Upon enactment, we, along with other providers and the AKF, filed suit challenging the validity of the law. Jane Doe, et al. v. Xavier Becerra, et al., 8:19-cv-02105, U.S. District Court for the Central District of California, Southern Division. In December 2019, the court issued a preliminary injunction staying implementation of the law. On January 9, 2024, the court issued a summary judgment decision which, among other things, upheld the provisions limiting reimbursement paid to providers who donate to the AKF when such reimbursement relates to services provided to patients who receive AKF support. On May 9, 2024, the court issued a final judgment, but stayed entry of such judgment while the parties appeal. See “— Regulatory and legal matters — Reimbursement — Possible changes in statutes or regulations” for further information on charitable premium assistance programs. Marietta Memorial Hospital Employee Health Benefit Plan, et al. v. DaVita Inc. et al. No. 20-1641: On November 5, 2021, the U.S. Supreme Court granted certiorari of an appeal by an employer group health plan, the plan sponsor, and the plan’s advisor of the U.S. Court of Appeals for the Sixth Circuit (Sixth Circuit) decision in DaVita Inc.’s favor. The questions presented involved whether the health plan violated the MSPA by “taking into account” that plan beneficiaries are eligible for Medicare and/or by “differentiating” between the benefits that the plan offers to patients with dialysis versus others. On June 21, 2022, the U.S. Supreme Court reversed the Sixth Circuit decision and held that the EGHP for Marietta Memorial Hospital did not violate the MSPA. The Marietta ruling makes it easier for health plans to design plan benefits for Medicare eligible ESRD patients in a way that makes private health insurance relatively less attractive to ESRD patients and Medicare relatively more attractive. The Restore Protections for Dialysis Patients Act, most recently introduced in the U.S. Congress in March 2025 but not enacted, would restore the interpretation of the Medicare Secondary Payer Act prior to the Marietta decision and ensure that patients cannot be discriminated against because of their need for dialysis. We cannot predict whether the U.S. Congress will enact this or any other proposed legislation that would reverse the potential effects of the Marietta decision. As Medicare and Medicaid reimbursement rates are generally lower than the reimbursement rates paid by commercial insurers, a shift of commercially insured patients to Medicare and Medicaid could have a material adverse impact on our business, financial condition, and results of operations. The Marietta ruling may also result in certain EGHPs reducing the benefits offered for dialysis, which could, depending on the number of patients impacted, have a material and adverse impact on our business, financial condition, and results of operation. There can be no assurance that this proposal or any other legislation to address the Marietta decision will be enacted. U.S. ballot initiatives and other legislation Further federal or state legislation or regulations may be enacted in the future through legislative and public referendum processes, which could substantially modify or reduce the amounts paid for services and products offered by us and our subsidiaries, mandate new or alternative operating models and payment models, and/or increase our operating expenses that could present more risk to our healthcare service operations. Ballot initiatives that are successfully introduced at the state level in the U.S. require the vote of state citizens to directly adopt or reject proposed new legislation. These ballot initiatives require a material expenditure of resources by us to participate in public discourse regarding the proposed new legislation underlying the initiatives, which if passed, could further regulate multiple aspects of our operations including, for instance, clinic staffing requirements, state inspection requirements and profit margins on commercial business. Efforts to enact new state laws regarding our operations are continuing. State regulation at this level would introduce an unprecedented level of oversight and additional expense at the clinic level which could have a material adverse effect on our business in the impacted states. It is also possible that statutes may be adopted or regulations may be promulgated in the future that impose additional eligibility requirements for participation in the federal and state healthcare programs. Such new legislation or regulations could, depending upon the detail of the provisions, have positive or adverse effects, possibly material, on our businesses and results of operations. See “— Regulatory and legal matters — Reimbursement – Possible changes in statutes or regulations,” below. 54 Table of Contents Environmental regulation We are subject to a broad range of federal, foreign, state and local laws and regulations relating to pollution and the protection of the environment. These laws regulate, among other things, the discharge of materials into the environment, the handling and disposal of medical and other wastes, remediation of contaminated sites and other matters relating to worker, public and consumer health and safety as well as to the protection of the environment. In addition, the Company uses substances regulated under U.S. and EU environmental laws, primarily in product design as well as manufacturing and sterilization processes. Noncompliance with these regulations can result in significant fines or penalties or limitations on our operations. The applicable environmental, health and safety laws and regulations, and any changes to them or their enforcement, may require us to make material expenditures with respect to ongoing compliance with or remediation under these laws and regulations or require that we modify our products or processes in a manner that increases our costs or reduces revenues. For information regarding our activities in the areas of energy and climate protection, water management, waste management and biodiversity and pollution, see “Environmental Management,” above. Facilities and operational regulation Operational conditions in recent years had an impact on the standard operating practices at our manufacturing facilities, distribution operations, and global clinic network and resulted in changes to these practices through the implementation of additional best practice procedures along with procedures required by the jurisdictions in which we operate. Within our production facilities and clinic network, we defined and implemented further hygiene and infection control measures and precautions in order to maintain sufficient clinical staff and available space to treat all of our patients, including those who are or may be infected with communicable diseases, while not unnecessarily exposing our care teams or other patients to whom we provide dialysis services, and who are among the groups most vulnerable to such infections. Vaccination is the top priority for our clinic network where vaccines for such diseases are available. U.S. Federal, state and local regulations (implemented by CMS, FDA, the Occupational Health and Safety Administration (OSHA), the Drug Enforcement Administration, and state departments or boards of public health, public welfare, medicine, nursing, pharmacy, and medical assistance, among others) require us to meet various standards relating to, among other things, the management, licensing, safety, security and operation of facilities (including, e.g., laboratories, pharmacies, and clinics), personnel qualifications and licensing, the maintenance of proper records, equipment, and quality assurance programs, and the dispensing, storage, and administration of controlled substances. All of our operations in the U.S. are subject to periodic inspection by federal, state and local agencies to determine if the operations, premises, equipment, personnel and patient care meet applicable standards. To receive Medicare/Medicaid reimbursement, our healthcare centers, renal diagnostic support business and laboratories must be certified by CMS. While all of our entities that furnish Medicare or Medicaid services maintain and renew the required certifications, material adverse effects on our business, financial condition, and results of operations could potentially occur if certain of those entities lose or are delayed in renewing a certification. Our operations are subject to various U.S. Department of Transportation, Nuclear Regulatory Commission, Environmental Protection Agency, and OSHA requirements and other federal, state and local hazardous and medical waste disposal laws. As currently in effect, laws governing the disposal of hazardous waste do not classify most of the waste produced in connection with the provision of our healthcare services as hazardous, although disposal of non-hazardous medical waste is subject to specific state regulation. Our operations are also subject to various air emission and wastewater discharge regulations. Several states have certificate of need programs regulating the establishment or expansion of healthcare facilities, including dialysis centers. We believe that we have obtained all necessary approvals for the operation of our healthcare facilities in accordance with all applicable state certificate of need laws. In states that also have certificate of need programs, the licensing requirements are separate and in addition to the need for certificates of need. 55 Table of Contents Non-U.S. We are subject to a broad spectrum of regulation in almost all countries. Our operations must comply with various environmental and transportation regulations in the various countries in which we operate. Our manufacturing facilities and dialysis clinics are also subject to various standards relating to, among other things, facilities, management, personnel qualifications and licensing, maintenance of proper records, equipment, quality assurance programs, the operation of pharmacies, the protection of workers from blood-borne diseases, and the dispensing of controlled substances. All of our operations may be subject to periodic inspection by various governmental authorities to determine if the operations, premises, equipment, personnel, and patient care meet applicable standards. Our dialysis clinic operations and our related activities generally require licenses, which may be subject to periodic renewal and may be revoked for violation of applicable regulatory requirements. In addition, many countries impose various investment restrictions on foreign companies. For instance, government approval may be required to enter into a joint venture with a local partner. Some countries do not permit foreign investors to own a majority interest in local companies or require that companies organized under their laws have at least one local shareholder. Investment restrictions may therefore affect the operating procedures and other characteristics of our subsidiaries and joint ventures in these and other countries. We believe our facilities are currently in compliance in all material respects with the applicable national and local requirements in the jurisdictions in which they operate. Reimbursement As a global company delivering healthcare and dialysis products, we are represented in more than 140 countries worldwide. Consequently, we face the challenge of addressing the needs of a wide variety of stakeholders, such as patients, customers, payors, regulators, and legislators in very different economic environments and healthcare systems. Healthcare systems and reimbursement structures for ESRD treatment vary significantly by country. In general, the government (in some countries in coordination with private insurers) or social and private insurance programs pay for healthcare. Funding is achieved through taxes and other sources of government income, from social security contributions, or a combination of those sources. However, not all healthcare systems provide for dialysis treatment. In some developing countries, only limited subsidies from government, social insurances, or charitable institutions are available, and typically dialysis patients must personally finance all or a substantial share of the treatment cost. Irrespective of the funding structure, in some countries patients needing dialysis do not receive treatment on a regular basis but rather only when financial resources allow. U.S. Our dialysis clinics provide outpatient hemodialysis treatment and related services for ESRD patients. In the U.S., Medicare pays as the primary insurer for Medicare-eligible individuals under many circumstances. Some patients pay for their healthcare services primarily through commercial insurance coverage. For Medicare primary patients, Medicare pays 80% of the prospective payment amount for the ESRD Prospective Payment system items and services. The beneficiary or third-party insurance payors (including employer-sponsored health insurance plans, commercial insurance carriers, including Medicare Advantage, Medicaid Risk plans and the Medicaid program) on behalf of the beneficiary are responsible for paying the beneficiary’s cost-sharing obligations (typically an annual deductible and 20% co-insurance), subject to the specific coverage policies of such payors. Each third-party payor, including Medicaid, makes payment under contractual or regulatory reimbursement provisions that may or may not cover the full 20% co-payment or annual deductible. Where the beneficiary has no third-party insurance or the third-party insurance does not fully cover the co-payment or deductible, the beneficiary is responsible for paying the co-payments or the deductible, which we frequently cannot fully collect despite collection efforts. Medicare’s ESRD Prospective Payment System. Under the ESRD PPS, CMS reimburses dialysis facilities with a single payment for each dialysis treatment, inclusive of (i) all items and services included in the former composite rate, (ii) calcimimetics (as of January 1, 2021), oral vitamin D analogues, oral levocarnitine, ESAs and other ESRD-related pharmaceuticals (other than vaccines and oral-only drugs) furnished to ESRD patients that were previously reimbursed separately under Part B or Part D of the Medicare program, (iii) most dialysis-related diagnostic laboratory tests and (iv) certain other items and services furnished to individuals for the treatment of ESRD. 56 Table of Contents Payment rates vary by both patient and facility. CMS subjects a base ESRD PPS payment rate to case-mix adjustments that take into account individual patient characteristics (e.g., age, body surface area, body mass) and certain co-morbidities. The base payment rate is also adjusted for (i) certain high cost patient outliers reflecting unusual variations in medically necessary care, (ii) disparately high costs incurred by low volume facilities relative to other facilities, (iii) provision of home dialysis training and (iv) wage-related costs in the geographic area in which the provider is located. The Protecting Access to Medicare Act of 2014 (PAMA) provides that rates will be updated by the market basket rate of increase net of multifactor productivity adjustment. The ESRD PPS also provides for: (i) a training add-on payment for home and self-dialysis modalities, (ii) a transitional drug add-on payment adjustment, (iii) a transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES), and (iv) beginning in 2024, for new renal dialysis drugs or biological products used to treat or manage a condition for which there is already an existing ESRD PPS functional category, a 3-year post-TDAPA add-on payment adjustment on all ESRD PPS claims, which provides increased payment following the end of the TDAPA period for those products. New renal dialysis drugs or biological products used to treat or manage a condition for which there is not an ESRD PPS functional category are not considered included in the ESRD PPS bundled payment. Such new renal dialysis drugs or biological products are paid for using the TDAPA. At the conclusion of that TDAPA period, CMS undertakes rulemaking to modify the ESRD PPS base rate, if appropriate, to account for the new renal dialysis drug or biological in the ESRD PPS bundled payment. The post-TDAPA add-on payment adjustment does not apply for these drugs or biological products. On November 20, 2025, CMS issued a final rule for the 2026 ESRD PPS, which CMS projects will increase the total aggregate payments to all ESRD facilities by 2.2%. For CY 2026, the ESRD PPS base rate is $281.71, an increase of $7.89 from the current CY 2025 base rate of $273.82. This amount reflects application of the final CY 2026 ESRD Bundled market basket update of 2.1%, which is the result of a 2.9% market basket increase offset by a 0.8% productivity adjustment, as well as applicable budget-neutrality adjustment factors. CMS notes in the final rule that the 1.0 percent target for outlier payments was not achieved in CY 2024 as outlier payments represented approximately 0.8 percent of total Medicare payments. The final Acute Kidney Injury payment rate for CY 2026 is equal to the CY 2026 ESRD PPS base rate. CMS also finalized a budget-neutral payment increase for ESRD facilities in Alaska, Hawaii, and the U.S. Pacific Territories. CMS also finalized the termination of the ESRD Treatment Choices (ETC) Model effective December 31, 2025. Sequestration of Medicare payments. On August 2, 2011, the BCA was enacted, raising the U.S. debt ceiling and putting into effect a series of actions for deficit reduction. The BCA, in effect, required automatic across-the-board spending cuts for most government programs over nine fiscal years (2013-2021); these cuts were projected to total $1.2 trillion. The first cuts for Medicare payments to providers and suppliers were initially implemented on April 1, 2013. As a result of subsequent legislation, these cuts have been extended through FY 2032. Under the BCA, as amended, the reduction in Medicare payments to providers and suppliers (the U.S. Sequestration) is limited to one adjustment of no more than 2% in each year through 2031, and in 2032 there will be an adjustment of 2% for the first half of FY 2032, dropping to 0.0% for the second half of FY 2032. The U.S. Sequestration is independent of Medicare’s annual inflation update mechanisms, such as the market basket update pursuant to the ESRD PPS. TDAPA and oral-only drugs. PAMA also included a provision addressing ESRD-related drugs with only an oral form, which are referred to as “oral-only” drugs and which have previously been paid separately. Subsequently, the Stephen Beck, Jr., Achieving a Better Life Experience Act of 2014 delayed inclusion of oral-only drugs in the ESRD PPS until January 1, 2025. Under the CY 2025 ESRD PPS Final Rule, oral-only drugs were approved for the TDAPA under the ESRD PPS. CMS will utilize the TDAPA for at least two years to collect utilization data before adding these drugs to the ESRD PPS base rate. The TDAPA is generally based on 100% of average sales price. If ASP is not available, then the TDAPA is based on 100% of wholesale acquisition cost (WAC). If WAC is unavailable, then the payment is based on the drug manufacturer’s invoice. As finalized in the CY 2025 ESRD PPS Final Rule, CMS will apply a fixed increase to the calculation of the monthly TDAPA amount during this transition period for claims that include the applicable new oral-only drugs, to cover the incremental operational costs of making these medications available to patients. At the end of this transition period, CMS will initiate rulemaking to modify the base rate, if appropriate, to account for these drugs in the ESRD PPS bundled payment, as CMS did in the CY 2021 final rule for calcimimetics. 57 Table of Contents In addition to the TDAPA payments for these oral-only drugs, CMS will continue the TDAPA payments for two additional drugs. Effective July 1, 2024, taurolidine and heparin sodium, a catheter lock solution instilled into the central venous catheter at the conclusion of each hemodialysis session, qualified for the TDAPA as a drug or biological product used to treat or manage a condition for which there is an existing ESRD PPS functional category. The TDAPA payment period began on July 1, 2024 and will continue through June 30, 2026, at which point the product will both become outlier eligible and also be included in the post-TDAPA add-on payment adjustment calculation. Additionally, effective January 1, 2025, vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor indicated for treating anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months, qualified for the TDAPA as a drug or biological used for anemia management, an existing ESRD PPS functional category. Vadadustat is eligible for the TDAPA throughout CY 2026 but does not qualify for outlier payments. Revisions to Medicare’s Physician Fee Schedule. The Medicare and CHIP Reauthorization Act of 2015 (MACRA) removed the periodic threat of substantial reductions in payment rates under the Physician Fee Schedule (PFS) that could have, if they had been permitted to take effect, significantly affected our businesses and those of our affiliated physicians. MACRA permanently removed the “sustainable growth rate” provision and in its place specified modest increases in PFS payment rates for the next several years. MACRA creates an elaborate scheme of incentive payments and penalty adjustments that started in 2019 based on 2017 physician performance as reflected in various measures of cost, use of health information technology, practice improvement activities, and quality of care and on possible participation in “advanced alternative payment models,” such as some accountable care organizations. We cannot predict whether this scheme is likely to have material effects on our revenues and profitability in our nephrology, urgent care, vascular, cardiovascular and endovascular specialty services. Through an annual rule-making cycle, CMS revises PFS payment rates to account for across-the-board updates as well as, from time to time, changes in the evaluation of physician work and practice expenses used to set rates for individual services paid under the PFS. While impacts of large changes are usually spread out over several years, such changes have the potential to affect the rates for specific services that are extensively furnished in our physician businesses and hence to affect materially the revenues of those businesses. On October 31, 2025, CMS released the final Physician Fee Schedule for CY 2026. As required by statute, beginning in CY 2026, there will be two separate conversion factors: one for alternative payment model (APM) qualifying participants (QPs) and one for physicians and practitioners who are not QPs. The final CY 2026 qualifying APM conversion factor of $33.57 represents a projected increase of $1.22 (+3.8%) from the current conversion factor of $32.35. Similarly, the final CY 2026 non-qualifying APM conversion factor of $33.40 represents a projected increase of $1.05 (+3.3%) from the current conversion factor of $32.35. The final updates are inclusive of the OBBBA one-time adjustment for 2026. The impacts of the final updates are expected to vary by specialty and site of service. On November 21, 2025, CMS released the CY 2026 final rule for hospital outpatient and ambulatory surgery center (ASC) payment systems. For CY 2026, CMS finalized an update factor to the ASC rates of 2.6%. ESRD PPS quality incentive program. The ESRD PPS’s Quality Incentive Program (QIP) affects Medicare payments based on performance of each facility on a set of quality measures. Based on a prior year’s performance, dialysis facilities that fail to achieve the established quality standards have payments for a particular year reduced by up to 2 percent. CMS updates the set of quality measures each year, adding, revising or retiring measures. Under the ESRD QIP, CMS assesses the total performance of each facility on a set of quality measures specified per payment year and applies up to a 2% payment reduction to facilities that do not meet a minimum total performance score. Beginning with QIP Payment Year (PY) 2027, CMS has removed the Facility Commitment to Health Equity reporting measure, Screening for Social Drivers of Health reporting measure and Screen Positive Rate for Social Drivers of Health reporting measure. CMS also finalized changes to In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems intended to reduce patient and facility burden. CMS has retained the COVID-19 Vaccination Coverage Among Healthcare Personnel measure and summarized responses to its requests for information on Health IT and potential quality measures related to nutrition and wellness. 58 Table of Contents Affordable Care Act. ACA provides for broad healthcare system reforms, including (i) provisions to facilitate access to private health insurance, (ii) expansion of the Medicaid program, (iii) industry fees on device and pharmaceutical companies based on sales of brand name products to government healthcare programs, (iv) increases in Medicaid prescription drug rebates, (v) commercial insurance market reforms that protect consumers, such as bans on lifetime and annual limits, coverage of pre-existing conditions, and limits on waiting periods, (vi) provisions encouraging integrated care, efficiency and coordination among providers (vii) provisions for reduction of healthcare program waste and fraud and (viii) a 2.3% excise tax on manufacturers’ medical device sales starting in 2013. However, pursuant to the Consolidated Appropriations Act of 2016, enacted December 18, 2015, the medical device excise tax was suspended for all sales of such devices in 2016 and 2017. On January 22, 2018, Congress passed a continuing resolution that further extended this moratorium for 2018 and 2019. In December 2019, Congress passed, and President Trump signed, a full FY 2020 domestic appropriations package that permanently repeals the medical device tax. In 2017, Congress considered legislation to “repeal and replace” ACA and may return to these issues in the future. The Biden administration did not support policies that it viewed as undermining ACA access, coverage and payment provisions and issued an executive order to review and examine policies or practices that may undermine the health insurance marketplace or the individual, small group, or large group markets for health insurance in the U.S. The Trump administration rescinded that executive order and has begun to pursue its own policies to address the cost of healthcare, focusing on policies related to lowering the cost of prescription drugs through “most-favored nation” policies and direct negotiations with pharmaceutical companies. The ACA included a provision referred to as the individual mandate, which requires most U.S. citizens and noncitizens to have health insurance that meets certain specified requirements or be subject to a tax penalty. On December 22, 2017, sweeping changes to the U.S. Tax Code were signed into law. Among the provisions included in the law was an amendment to this ACA provision that reduced to zero the excise tax penalty imposed on individuals who do not obtain minimum essential healthcare coverage. The provision became effective in 2019. The Congressional Budget Office estimated in November of 2017 that elimination of the mandate had the potential to decrease the number of individuals with health insurance by approximately 4 million in 2019 and premiums were likely to increase because healthier individuals were likely to opt out of paying for health insurance without the influence of a penalty. On February 26, 2018, the Texas and Wisconsin Attorneys General, leading a 20-state coalition, filed a lawsuit challenging the constitutionality of the ACA in the Northern District of Texas titled Texas and Wisconsin, et al v. United States, et al (N.D. Tex). The plaintiffs argued that because the amendment “renders legally impossible the Supreme Court’s prior savings construction of the Affordable Care Act’s core provision – the individual mandate – the Court should hold that the ACA is unlawful and enjoin its operations.” On December 14, 2018, the Court granted a partial summary judgment finding the individual mandate unconstitutional and the remaining provisions of the ACA inseparable, and therefore invalid, and granted the plaintiffs’ claim for declaratory relief in Count 1 of the amended complaint. On December 30, 2018, the Court issued a final judgment on Count 1, which enabled the decision to be appealed. In December 2019, a three-judge panel from the U.S. Court of Appeals for the Fifth Circuit affirmed a district court ruling that found the individual mandate to be unconstitutional because it can no longer be read as a tax, and there is no other constitutional provision that justifies this exercise of congressional power. The Supreme Court issued an opinion in the case, California v. Texas v. Azar, on June 17, 2021 denying the plaintiffs’ constitutional challenge to the ACA on the grounds that they lacked standing. Pharmaceuticals. We participate in the federal Medicaid rebate program established by the Omnibus Budget Reconciliation Act of 1990, as well as other government reimbursement programs including Medicare Part D Gap, TriCare and state pharmacy assistance programs established according to statutes, government regulations and policy. We make our pharmaceutical products available to authorized users of the Federal Supply Schedule (FSS) of the General Services Administration under an FSS contract negotiated by the Department of Veterans Affairs. Under our license to market and distribute the intravenous iron medication Venofer® to freestanding dialysis clinics, we also are considered, for statutory price reporting purposes, to be the manufacturer of Venofer® (when sold by us under one of our national drug codes (NDCs)), which is reimbursed under Part B of the Medicare program. Our products are also subject to a federal requirement that any company participating in the Medicaid rebate or Medicare program charge prices to Medicare comparable to the rebates paid by State Medicaid agencies on purchases under the Public Health Services (PHS) pharmaceutical pricing program managed by the Department of Health and Human Services (also known as the “340B program” by virtue of the section of the Public Health Service Act that created the program). The PHS pricing program extends these deep discounts on outpatient drugs to a variety of community health clinics and other entities that receive health services grants from the PHS, certain “look alikes,” as well as various other providers. ACA expanded the 340B program to include additional providers. 59 Table of Contents Under the Medicaid rebate program, we pay a rebate to each state Medicaid program based upon sales of our covered outpatient drugs that are separately reimbursed by those programs. ACA increased the minimum federal Medicare rebate percentages, effective January 1, 2010. Rebate calculations and price reporting rules are complex and, in certain respects, subject to interpretations of law, regulation, or policy guidance by us, government or regulatory agencies and the courts. The Medicaid rebate amount is computed each quarter based on our submission to CMS of our current Average Manufacturer Price and Best Price for our pharmaceutical products. The Veterans Health Care Act imposes a requirement that the prices we charge to certain federal entities under the FSS must be no greater than the Federal Ceiling Price, which is determined by applying a statutory discount to the average price charged to non-federal customers through wholesalers. Because the amount the government pays to reimburse the cost of a drug under Part B of the Medicare program is ordinarily based on the drug’s average sales price (ASP), additional price calculation and reporting obligations are imposed on the manufacturers of Part B drugs under that program (to the extent these manufacturers participate in the Medicaid rebate program, from which an obligation to report Part B drug prices flows). Since Venofer® is covered under Part B, we are responsible for compiling and utilizing a wide range of sales data elements to determine the ASP of Venofer® marketed under our NDCs and reporting it to CMS. The Medicare ESRD PPS system incorporates payment for Venofer® at dialysis facilities. Government agencies may make changes in program interpretations, requirements or conditions of participation, and retain the right to audit the accuracy of our computations of rebates and pricing, some of which may result in implications (such as recoupment) for amounts previously estimated or paid which may have a material adverse effect on our operating results. Laboratory tests. Spectra obtains a portion of its revenue from Medicare, which pays for clinical laboratory services provided to dialysis patients in two ways. Payment for most tests is included in the ESRD PPS bundled rate paid to dialysis clinics. The dialysis clinics obtain the laboratory services from laboratories and pay the laboratories for the services. In accordance with industry practice, Spectra usually provides such testing services under capitation agreements with its customers pursuant to which it bills a fixed amount per patient per month to cover the laboratory tests included in the ESRD PPS rate designated in the capitation agreement. Second, the few laboratory tests performed by Spectra for Medicare beneficiaries that are not included in the ESRD PPS bundled rate are billed separately to Medicare. Such tests are paid at 100% of the payment amounts on Medicare’s Clinical Laboratory Fee Schedule (CLFS), although payment rates are further reduced by a 2% sequestration adjustment that remains in place until further notice. PAMA required CMS to substantially revise how payment rates are determined under the CLFS. The new rates, effective January 1, 2018, were determined based on the median of rates paid by private payors for these tests in the period before the new rates took effect. The new rates are effective for most tests for a three-year period, with no updates during that period for inflation or other factors. PAMA provided that rate declines were limited to 10% in each of the first three years. The Continuing Appropriations and Extensions Act of 2026 is the latest in a series of legislation which extended the phase-in of payment reductions. There is no reduction for 2021-January 30, 2026 and payment may not be reduced by more than 15% from January 31, 2026 through 2028. Payment rates for the majority of tests paid on the CLFS were reduced under PAMA. These declines are not expected to directly affect Spectra’s principal source of revenue, payments from dialysis facilities for laboratory tests included in the ESRD PPS. For information regarding our sale of select assets of our wholly owned Spectra Laboratories, see note 4 of the notes to our audited consolidated financial statements included in this report. Coordination of benefits. Medicare entitlement begins for most patients at least three months after the initiation of chronic dialysis treatment at a dialysis center. During the first three months, considered to be a waiting period, the patient or patient’s insurance, Medicaid or a state renal program is generally responsible for payment. Patients who are covered by Medicare and are also covered by an EGHP are subject to a 30-month coordination period during which the EGHP is the primary payor and Medicare the secondary payor. During this coordination period, the EGHP pays a negotiated rate or in the absence of such a rate, our standard rate or a rate defined by its plan documents. The EGHP payments are generally higher than the Medicare payment. EGHP insurance, when available, will therefore generally cover as the primary payor for a total of 33 months, including the 3-month waiting period plus the 30-month coordination period. Any significant decreases in EGHP reimbursement rates could have material adverse effects on our provider business and, because the demand for our products is affected by provider reimbursement, on our products business. 60 Table of Contents Participation in other Medicare payment arrangements. We conduct a broad range of value and risk-based care programs spanning CKD and ESRD patient populations with both private and public payors. Value and risk-based care programs include shared risk arrangements in which private payors or government programs share the savings or losses from reductions or increases in the overall medical spend of a population under management assuming that certain quality thresholds are also met. Full risk arrangements include capitated arrangements and shared saving arrangements in which private payors or government programs reimburse us based on savings generated in the management of such members. Since capitation arrangements often can be recognized as premium revenue and the full medical premium for ESRD beneficiaries generally is very large, capitation programs can drive significant revenue and, when costs are effectively managed, profit opportunities. We participate in value and risk-based care programs with private payors to provide care to commercial and Medicare Advantage ESRD and CKD patients. Under these payment arrangements, our financial performance is based on our ability to manage a defined scope of medical costs within certain parameters for clinical outcomes. Other programs, such as the ESRD Treatment Choices model and the Comprehensive Kidney Care Contracting model, are described in more detail below. Executive order-based models. On July 10, 2019, an Executive Order on advancing kidney health was signed in the United States. Among other things, the order instructed the Secretary of the HHS to develop new Medicare payment models to encourage identification and earlier treatment of kidney disease as well as increased home dialysis and transplants. One of those models, for which the rule was finalized on September 29, 2020 and later amended through finalized changes on October 29, 2021, the ETC model, is a mandatory model that creates financial incentives for home treatment and kidney transplants with a start date in January 2021 and an originally scheduled ending in June 2027. On November 20, 2025, CMS finalized the termination of the ETC model as of December 31, 2025 and modified the duration during which CMS will apply payment adjustments. This model applied both upside and downside payment adjustments to claims submitted by physicians and dialysis facilities for certain Medicare home dialysis patients over the model’s tenure. Participants in this model were based on a random selection of 30% of in certain randomly selected geographic regions (specifically, Hospital Referral Regions) that comprised approximately 30% of adult ESRD beneficiaries in all 50 states and the District of Columbia. As of December 31, 2025, 970 of our U.S. dialysis facilities, representing approximately 35% of our U.S. dialysis facilities, were within the random selection of Hospital Referral Regions and therefore are in areas selected for participation in the model. An initial upside-only payment, Home Dialysis Payment Adjustment (HDPA), was applied for the first three years of the model, beginning in January 2021, in decreasing payment adjustments ranging from 3% in the first HDPA payment year, to 2% in the second HDPA payment year, and to 1% in the final HDPA payment year. This model also includes a Performance Payment Adjustment (PPA) beginning in July 2022. PPA payments will be a combined calculation of home dialysis (home, self-dialysis and nocturnal in-center) and transplant (living donor transplants and transplant waitlist) rates based upon a participant’s historic performance and/or increasingly weighted benchmark data from comparison geographic areas. CMS utilizes a two-tiered approach in PPA scoring to stratify participants with a high volume of beneficiaries who are dual-eligible for Medicare and Medicaid or Low Income Subsidy recipients. On October 31, 2022, CMS finalized refinements to the ETC model, including a change to the improvement in scoring methodology and a change to the requirements related to flexibilities regarding furnishing and billing kidney disease patient education services under the ETC model. CMS also discussed its intent to publish participant-level performance data. These changes did not result in additional estimated savings to the Medicare program. At this time, our payment adjustments from the ETC model have resulted in a net positive adjustment. With the early termination of the ETC model at December 31, 2025, the PPAs will be discontinued, and all dialysis facilities will return to standard Medicare reimbursement rates in 2026. Pursuant to the Executive Order, the Secretary of HHS also announced voluntary payment models, Kidney Care First (KCF) and CKCC models (graduated, professional and global), aim to build on the existing Comprehensive ESRD Care model. These voluntary models create financial incentives for healthcare providers to manage care for Medicare beneficiaries with CKD stages 4 and 5 and with ESRD, to delay the start of dialysis, and to incentivize kidney transplants. The voluntary models allow healthcare providers to take on various amounts of financial risk by forming an entity known as a KCE. Two options, the CKCC global and professional models, allow renal healthcare providers to assume upside and downside financial risk. A third option, the CKCC graduated model, is limited to assumption of upside risk, but is unavailable to KCEs that include large dialysis organizations such as the Company. Under the global model, the KCE is responsible for 100% of the total cost of care for all Medicare Part A and B services for aligned beneficiaries, and under the professional model, the KCE is responsible for 50% of such costs. As of December 31, 2025, we participated in 21 KCEs. Twenty KCEs began assuming financial risk within the first performance year that commenced January 1, 2022, and four began assuming financial risk within the second performance year that commenced January 1, 2023. Subsequently, three KCEs ended performance. The CKCC model is expected to run through 2027. In September 2025, CMS released the performance scores for the 2024 performance year in which the majority of the KCEs organized in Value-Based Care qualified as high performers in various quality metrics. As of December 2025, approximately 52,000 patients were aligned to KCEs in which we participated. 61 Table of Contents Federal surprise billing statute and regulations. The No Surprises Act was enacted on December 27, 2020 as part of the 2021 Budget Act. The No Surprises Act aims to address surprise, balance billing to patients at the national level (many states already had laws regulating balance billing). Effective January 1, 2022, the legislation limits patient payment responsibility for certain unavoidable out-of-network services, prohibits certain providers and facilities (not including dialysis facilities) from balance billing patients for those services, establishes price transparency disclosure requirements for providers and insurers and mandates creation of dispute resolution processes for patients, providers and insurers to address unanticipated medical bills. The Department of Labor, HHS and the Department of the Treasury have collectively issued several Final Rules to implement the requirements of the statute. The statute and regulations have only limited applicability to our business: our ASCs and certain providers of services ancillary to ASC services (such as anesthesia) are subject to certain requirements of the statute and regulations; and our dialysis facilities are subject to certain requirements of the statute and regulations with respect to price transparency for individuals who are uninsured or “self-pay” (i.e., individuals who plan to pay out of pocket without using insurance). Possible changes in statutes or regulations. Further federal or state legislation or regulations may be enacted in the future that could substantially modify or reduce the amounts paid for services and products offered by us and our subsidiaries and/or implement new or alternative payment models for dialysis that could present more risk sharing for dialysis clinics. For example, ballot initiatives introduced at the state level which could further regulate clinic staffing requirements, state inspection requirements and commercial reimbursement rates. Additionally, in response to the COVID-19 pandemic, the federal and state governments implemented wide-ranging, temporary measures that have affected the regulatory and legal landscape in which we operate. These measures included temporary waivers and modifications to certain statutes, regulations, government reimbursement and funding programs and the governments’ enforcement priorities. While the public health emergency has ended, certain of the emergency measures such as certain telehealth services remain in effect. To the extent we rely on such measures, in certain circumstances we could be forced to change our operations if reliance upon those measures that continue to exist is terminated. Non-U.S. A country’s approach to reimbursement and market pricing is markedly influenced by the type of healthcare funding system it employs. In the major European and British Commonwealth countries, healthcare systems are generally based on one of two funding models. The healthcare systems of countries such as Germany, France, Belgium, Austria, Czech Republic and Poland are based on the Bismarck-type system; where mandatory employer and employee contributions dedicated to healthcare financing are required. Countries such as the United Kingdom, Canada, Denmark, Finland, Portugal, Sweden and Italy established their national health services using the Beveridge-type system, which provides a national healthcare system financed by taxes. However, during the last decade, healthcare financing under many social security systems has also been significantly subsidized with tax money. In the Asia-Pacific region, Universal Health Care (UHC) is at varying stages of implementation and, as such, reimbursement mechanisms may vary significantly between countries (including variances at the state, provincial or city level). Tax-based healthcare funding systems are mostly seen in New Zealand, Malaysia and Thailand where governments have more direct levers to manage the provision of healthcare. Other countries, such as Japan and South Korea, finance healthcare through social health insurance mandating citizens to make contributions into a pooled fund. In Taiwan, dialysis costs for all patients with ESRD are reimbursed by national health insurance, with the government covering premiums in the case of low-income citizens. Singapore has a multi-tier system with mandatory medical savings account alongside means-tested subsidies to cover catastrophic illnesses. Indonesia and India continue their effort to achieve UHC amidst system challenges. India has a fragmented and complex payer landscape involving both government and private payors. Out-of-pocket expenses remain a large contribution of the overall healthcare expenditure in the country. The Pradhan Mantri National Dialysis Programme launched the Ayushman Bharat Yojana, a national health insurance scheme aimed at providing free access to healthcare for low-income earners, in 2018. Coverage is expanding, but payors and providers are also increasingly implementing cost containment strategies across the region to manage the rising demand for healthcare. On September 11, 2024, the prime minister approved a major expansion of the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY), whereby all senior citizens aged 70 and above will receive health coverage regardless of their income. As per the latest estimate, dialysis is the most available therapy, accounting for 14% of overall disbursement. South Korea has a universal national health insurance system with a fee-for-service payment scheme in place based on employee taxes, government subsidies, tobacco surcharges and other contributions. For dialysis specifically, a 9:1 ratio exists where the insurance scheme covers 90% of the dialysis costs and 10% must be paid by the patient out-of-pocket. 62 Table of Contents China has achieved UHC by establishing a tiered healthcare system nationwide and a multi-layer medical insurance system (MLMIS) covering approximately 95% of its population. For the MLMIS, the main coverage scheme is Basic Medical Insurance (BMI) composed of employees’ BMI and residents’ BMI (the basic insurance every citizen receives independent of employment status), administrated by the National Healthcare Security Administration (NHSA). The system includes reimbursement for drugs listed in the National Reimbursement Drug List (NRDL) and partial medical services listed in the National Basic Medical Insurance Diagnostic and Treatment Programs. For employees’ BMI, the pooled funds come from employer contribution and employee payroll tax and is much more prominent than the contribution of the residents’ BMI, leading to more comprehensive healthcare coverage. For residents’ BMI, the NHSA merged the insurance schemes for urban and rural residents at the national level in 2019 and began applying the terminology of “basic medical insurance for urban and rural residents” as one statistical item in the NHSA annual report. However, the threshold and compensation level remain different between urban and rural residents. Given the large geographical disparity in terms of economic development and BMI pooled funds, the specific reimbursement policies issued by local Health Security Administration vary, although general guidance of the NHSA is followed. Similarly to national standards of healthcare coverage and reimbursement, there is a clear trend for volume-based procurement of medical technologies. In the Latin America region, healthcare systems are funded by public payors, private payors or a combination of both. For countries such as Argentina, Brazil, Chile, Colombia, Curaçao, Ecuador, Guatemala and Peru, UHC covers ESRD for all citizens, funded by employers as well as individual compulsory contributions. In general, UHC is not yet fully implemented. Even though most countries in the region legally guarantee treatment in practice, access remains uneven. Regional budget limitations and differences in service availability often create significant gaps. Most countries in Latin America in which we operate have differentiated reimbursement between therapies and differences between public and private reimbursement. Value-based healthcare initiatives are starting, but limited due to the many countries that have significant economic constraints. Private insurers complement healthcare coverage, particularly in Argentina, Brazil and Colombia, and may be preferred by patients for a better quality of treatment or convenience. Each payor (public or private) defines its own tariff, subject to a yearly revision to restore the value eroded by inflation. In Colombia, competition bids for lower prices without regard to adjusted tariffs and in Brazil, where public payors represent more than 80% of the share. High inflation and currency fluctuations continue to affect dialysis costs, often without matching adjustments in reimbursement rates. For information regarding our divestitures of businesses in certain Latin American countries, see note 5 e) of the notes to our audited consolidated financial statements included in this report. Remuneration for ESRD treatments widely differs between countries but there are three broad types of reimbursement modalities: global budget, fee-for-service reimbursement and a bundled payment or capitation rate paid at predetermined periods. In some cases, reimbursement modalities may also vary within the same country depending on the type of healthcare provider (public or private). Budget allocation is a reimbursement modality used mainly for public providers in most European countries where the funding is based on taxation and in some of the countries where it is based on social security. Fee-for-service, which used to be the most common reimbursement modality for private providers in European and Asia-Pacific countries, is increasingly being replaced by periodic reimbursement bundles. These include different components of the ESRD treatment and level of payment is linked to certain quality parameters. Additionally, in all countries, operations are increasingly subject to cost management strategies (also due to inflation) as a significant increase in logistic cost, personnel cost, raw materials and other costs are not fully reflected in reimbursement changes. Additionally, many health systems apply health technology assessments methods (a strict analysis on the entry of new products and services), which require additional data, reviews and administrative processes, all of which increase the complexity, timing and costs of obtaining reimbursement for products and services, simultaneously putting continuous downward pressure on available reimbursement. In June 2021, the EU approved the EU Health Technology Assessments Regulation which will fully enter into force in 2025 and is expected to unify and further reinforce the trend. In addressing these cost containment pressures, the Company is developing more expertise in the Health Economics, Market Access and Political Affairs fields in order to respond, counteract and proactively anticipate health system funding changes that impact our business. The main aim of this development is to demonstrate that our products and services create value for patients and for those who pay for healthcare. The Company advocates to encourage a long-term partnership for sustainable healthcare financing and value-based payment programs. 63 Table of Contents Generally, in European countries with established dialysis programs, reimbursements range from €70 to more than €400 per treatment. In Asia-Pacific and Latin America, reimbursement rates can be significantly lower. Where treatment is reimbursed on a fee-for-service basis, reimbursement rates are sometimes allocated in accordance with the type of treatment performed. However, because the services and costs that are reimbursed differ widely between countries, calculation of an average global reimbursement amount would likely bear little relation to the actual reimbursement system in any one country. Hence, country comparison will be relevant only if it includes an analysis of the cost components covered, including their individual costs, services rendered and the structure of the dialysis clinic in the countries being compared. In light of the inflationary environment and geopolitical volatility, the medical device industry is facing significant cost increases which cannot be easily transferred as price increases to healthcare customers that need to operate under a fixed budget. Nevertheless, reimbursement and price increases have been acknowledged and granted in some health systems already and discussions are ongoing in most countries. Anti-kickback statutes, False Claims Act, Stark Law and other fraud and abuse laws in the United States Some of our operations are subject to federal and state statutes and regulations governing financial relationships between healthcare providers and potential referral sources and reimbursement for services and items provided to patients with Medicare, Medicaid and other types of U.S. Government and state government health insurance. Our operations are also subject to federal statutes that govern the relationships and assistance that we may provide to our patients. Such laws include the Anti-Kickback Statute, the False Claims Act, the Stark Law, the Civil Monetary Penalty Law and other federal healthcare fraud and abuse laws and similar state laws. The U.S. Government, many individual states and private third-party risk insurers have devoted increasing resources to combat fraud, waste, and abuse in the healthcare sector. The Office of the Inspector General of HHS (OIG), state Medicaid fraud control units, and other enforcement agencies have dedicated substantial resources to their efforts to detect arrangements and practices that may violate fraud and abuse laws. The government’s ability to pursue actions against potential violators has been enhanced over the past years, by expanding the government’s investigative authority, expanding criminal and administrative penalties, by increasing funding for enforcement and providing the government with expanded opportunities to pursue actions under the federal Anti-Kickback Statute, the False Claims Act, and the Stark Law. For example, the ACA narrowed the public disclosure bar under the False Claims Act, allowing increased opportunities for whistleblower litigation. In addition, the legislation modified the intent standard under the federal Anti-Kickback Statute, making it easier for prosecutors to prove that alleged violators had met the requisite knowledge requirement. The ACA and implementing regulations also require providers and suppliers to report any Medicare or Medicaid overpayment and return the overpayment on the later of 60 days of identification of the overpayment or the date the cost report is due (if applicable), or else all claims associated with the overpayment will become false claims. The ACA also provides that any claim submitted from an arrangement that violates the Anti-Kickback Statute is a false claim. In late 2020, both CMS and the OIG issued final rules that implemented changes to the regulations for the Stark Law, Anti-Kickback statute and Civil Monetary Penalty Law. These rules were aimed at easing the burden of compliance and promoting coordinated care and value-based care. 64 Table of Contents Healthcare reform In response to increases in healthcare costs in recent years, there have been, and continue to be, proposals by the federal government, state governments, regulators and third-party payors to control these costs and reform the U.S. healthcare system. The ACA, enacted in 2010, contained broad healthcare system reforms, including (i) provisions to facilitate access to affordable health insurance for all Americans, (ii) expansion of the Medicaid program, (iii) an industry fee on pharmaceutical companies starting in 2011 based on sales of brand name pharmaceuticals to government healthcare programs, (iv) increases in Medicaid prescription drug rebates effective January 1, 2010, (v) commercial insurance market reforms that protect consumers, such as bans on lifetime and annual limits, coverage of pre-existing conditions, and limits on waiting periods, (vi) provisions encouraging integrated care, efficiency and coordination among providers (vii) provisions for reduction of healthcare program waste and fraud and (viii) a 2.3% excise tax on manufacturers’ medical device sales starting in 2013. However, pursuant to the Consolidated Appropriations Act of 2016, which was signed into law on December 18, 2015, the medical device excise tax was suspended for all sales of such devices in 2016 and 2017. On January 22, 2018, Congress passed a continuing resolution that further extended this moratorium for 2018 and 2019. In December 2019, Congress passed, and former President Trump signed, a full FY 2020 domestic appropriations package that permanently repeals the medical device tax. Throughout the years of the Obama Administration, the Republicans in Congress attempted on several occasions to repeal the ACA, recognizing that any such effort would be rejected by a Presidential veto. Similarly, during the 2016 Presidential campaign, President Trump called for a repeal and replacement of the ACA, though no legislation to repeal the ACA passed during his first term in office. In the 2020 Presidential campaign, President Biden called for further expansions of the ACA, the potential for a reduction in Medicare eligibility age, and a so-called “public option.” In 2021, Congress passed the America Rescue Plan which increased the subsidies available under the ACA’s individual market exchanges to further decrease the cost of coverage. These enhanced subsidies expired at the end of 2025. We cannot predict what actions Congress or current administration will implement to address a potential reduction in insurance coverage as a result of this expiration. In National Federation of Independent Business v. Sebelius, the U.S. Supreme Court affirmed the right of individual states to elect whether or not to participate in the ACA’s Medicaid expansion. As of November 2025, forty states (and the District of Columbia) elected to expand their programs. Because 10 states have so far declined to participate, the number of uninsured individuals is greater than originally expected when the ACA was passed. We cannot predict whether additional states will agree to participate in the expansion in future years, presuming that there is no change in the current law. The first Trump administration and several states led by Republican Governors filed suit to challenge the constitutionality of the ACA and, in particular, its requirement that all U.S. citizens purchase health coverage, known as the “individual mandate.” In December 2019, a three-judge panel from the U.S. Court of Appeals for the Fifth Circuit affirmed a district court ruling that found the mandate to be unconstitutional because, after elimination of the excise tax penalty imposed on individuals who do not obtain minimum essential healthcare coverage, there is no other constitutional provision that justifies this exercise of congressional power. On June 17, 2021, the Supreme Court issued an opinion in the case, California v. Texas, upholding the ACA. For additional information, see “—Reimbursement – U.S. – ESRD PPS quality incentive program” above. The first Trump administration revised regulations to the implementation of various provisions of the ACA and, in 2017, halted CSR payments to insurers, prompting premium increases as insurers were still required to offer reduced cost-sharing to low-income enrollees. Although the Trump administration later sought authority to fund CSRs in its FY 2019–2021 budgets, Congress did not authorize the payments. The Biden administration likewise requested CSR appropriations for FY 2023 and FY 2024, but Congress did not include them. Litigation over the previous administration’s non-payment is ongoing: courts have held the government owes CSRs for 2017 and must determine amounts owed for subsequent years, and the U.S. Supreme Court declined further review in 2021. President Biden’s 2021 Executive Order directed agencies to reverse policies undermining the ACA and suggested renewed support for CSR funding. There continue to be discussions in Congress and within the Trump administration about funding the CSRs, but it is unclear if efforts to appropriate the CSRs will be successful. To encourage health insurers to participate in the public exchanges, the ACA created the Risk Corridors Program, a temporary framework to compensate insurers for unexpectedly unprofitable plans during the ACA’s first three years. Pursuant to a formula, insurers with profits exceeding a certain amount were required to pay to the government a portion of the excess profits, and insurers that experienced higher than expected loses would be reimbursed by the government. Rather than paying the amounts owed, Congress, through appropriations riders, prevented CMS from paying these amounts for each year of the program. On April 27, 2020, the U.S. Supreme Court ruled in Maine Community Health Options v. United States that that the federal government must pay over $12 BN to health insurers that sold consumer policies on public exchanges and had claimed losses under the Risk Corridors Program established by the ACA. 65 Table of Contents In addition, further regulations may be promulgated in the future that could substantially change the Medicare and Medicaid reimbursement systems, or that could impose additional eligibility requirements for participation in the federal and state healthcare programs. Moreover, such regulations could alter the current responsibilities of third-party insurance payors (including employer-sponsored health insurance plans, commercial insurance carriers and the Medicaid program) including, without limitation, with respect to cost-sharing. Changes of this nature could have significant effects on our businesses, but the outcomes and impact of such changes on our business, financial condition, and results of operations are impossible to quantify or predict. On March 31, 2023, the continuous Medicaid enrollment provision of the Families First Coronavirus Response Act (FFCRA) expired. This provision allowed Medicaid beneficiaries to maintain continuous coverage during the COVID-19 pandemic without affirmatively renewing coverage each year. Since the expiration of the continuous enrollment provision of the FFCRA, a number of states have disenrolled Medicaid beneficiaries who have not elected to renew their Medicaid enrollment. These actions by states have resulted in a number of previous Medicaid beneficiaries losing coverage. The One Big Beautiful Bill Act (P.L. 119-21) was signed into law on July 4, 2025. Focused on extending President Trump’s 2017 tax cuts and other domestic policy priorities, the OBBBA includes provisions that limit coverage in Medicaid, Medicare, and the ACA exchanges. Medicaid provisions include approximately $1 trillion in funding cuts to Medicaid through 2034; limits on state-levied taxes on healthcare providers (so-called “provider taxes”) (decreasing from 6% of provider revenues to 3.5% of net patient revenues by 2031) and limits on state-directed payment programs (from average commercial rates to either 100% (ACA expansion) or 110% (ACA non-expansion) of the Medicare payment rates, with certain exceptions), both often used to finance the states’ share of Medicaid spending; increased eligibility verification; limitations on retroactive eligibility; prevention of certain non-citizens from enrolling or receiving benefits under Medicaid; requirement for states to implement cost-sharing for certain populations, and work requirements for certain “able-bodied” beneficiaries (excludes beneficiaries with Medicare Part A/B and with a serious, complex medical condition), among other provisions. Medicare provisions prohibit certain non-citizens from being eligible for Medicare; provide a 2.5% increase in the Medicare Physician Fee Schedule for 2026 as a one-time adjustment; and expand the exemption of certain orphan drugs from the Medicare Drug Price Negotiation Program. The OBBBA also established a $50 BN Rural Health Transformation Program to help fund rural hospitals and other providers over 5 years in an effort to offset decreases in Medicaid funding. ACA-related provisions of the OBBBA limit the availability of premium tax credits for plans through the ACA marketplace to certain non-citizens, shorten the open enrollment period, and eliminate automatic re-enrollment. Overall, the OBBBA includes significant changes involving funding, enrollments, and eligibility. While it is too early to predict the magnitude of the changes or the cumulative effect on the Company, it is important to note that revenues from Medicaid and other government sources (excluding Medicare and Medicare Advantage funds) represented 4.7% of U.S. patient service revenues for the year ended December 31, 2025 (2024: 4.5%). We do not expect the changes resulting from the tax provisions in OBBBA to have a material impact on our effective tax rate or on our cash tax position. C. Organizational structure The following chart shows our organizational structure and our significant subsidiaries as of December 31, 2025. Fresenius Medical Care Holdings, Inc. conducts its business as “Fresenius Medical Care North America.” For additional discussion regarding the Company’s principal subsidiaries, see note 1 a) of the notes to our audited consolidated financial statements included in this report. 66 Table of Contents D. Property, plant and equipment Property The table below describes our principal facilities. We own the land and buildings comprising our principal production facilities in Schweinfurt and St. Wendel, Germany and we lease our corporate headquarters in Bad Homburg, Germany on a long-term basis from Fresenius SE or one of its affiliates. These leases and the purchase of our principal production facilities from Fresenius SE companies are described in note 6, “Related party transactions,” of the notes to the consolidated financial statements included in this report. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Floor area ​ Currently ​ ​ ​ ​ ​ ​ (approximate ​ owned or ​ Lease ​ ​ Location ​ ​ ​ square meters) ​ ​ ​ leased ​ ​ ​ expiration ​ ​ ​ Use ​ ​ ​ ​ ​ ​ ​ ​ ​ Suzhou, China (Changshu Plant) ​ 119,516 ​ leased / owned ​ August 2055 / December 2056 ​ Manufacture of hemodialysis bloodline sets & AV Fistula set, HD dialyzer and peritoneal dialysis solutions ​ ​ ​ ​ ​ ​ ​ ​ ​ St. Wendel, Germany ​ 113,285 ​ owned ​ ​ ​ Manufacture of polysulfone membranes, dialyzers and peritoneal dialysis solutions; research and development ​ ​ ​ ​ ​ ​ ​ ​ ​ Ogden, Utah,U.S. ​ 102,193 ​ owned ​ ​ ​ Manufacture of polysulfone membranes and dialyzers and peritoneal dialysis solutions; research and development ​ ​ ​ ​ ​ ​ ​ ​ ​ Biebesheim / Gernsheim, Germany ​ 65,000 ​ leased ​ December 2026 / December 2028 ​ Central distribution Europe, Asia-Pacific and Latin America ​ ​ ​ ​ ​ ​ ​ ​ ​ L´Arbresle, France 47,765 owned ​ Manufacture of polysulfone dialyzers, special filters, dry & liquid hemodialysis concentrates, empty pouches, injection molding ​ ​ ​ ​ ​ ​ ​ ​ ​ Schweinfurt, Germany 38,100 owned ​ Manufacture of hemodialysis machines and peritoneal dialysis cyclers; research and development ​ ​ ​ ​ ​ ​ ​ ​ ​ Fukuoka, Japan (Buzen Plant) 37,092 owned ​ Manufacture of peritoneal dialysis bags and dialyzers ​ ​ ​ ​ ​ ​ ​ ​ ​ Bogota, Colombia 37,979 owned ​ Manufacture of dry and liquid concentrates, CAPD and APD bags, intravenous solutions, empty Biofine bags ​ ​ ​ ​ ​ ​ ​ ​ ​ Waltham, Massachusetts,U.S. 36,473 leased April 2029 Corporate headquarters and administration - U.S. ​ ​ ​ ​ ​ ​ ​ ​ ​ Enstek, Malaysia 28,778 owned ​ Manufacture of peritoneal dialysis solutions and hemodialysis concentrate ​ ​ ​ ​ ​ ​ ​ ​ ​ Fukuoka, Japan (Buzen Plant) 27,943 owned ​ Manufacture of peritoneal dialysis bags and dialyzers ​ ​ ​ ​ ​ ​ ​ ​ ​ Knoxville, Tennessee,U.S. 27,637 owned ​ Manufacture of peritoneal dialysis solutions ​ ​ ​ ​ ​ ​ ​ ​ ​ Palazzo Pignano, Italy 27,435 owned ​ Manufacture of bloodlines and tubing, office ​ ​ ​ ​ ​ ​ ​ ​ ​ São Paulo, Brazil 20,159 owned ​ Manufacture of hemodialysis concentrate solutions, dry hemodialysis concentrates, peritoneal dialysis bags, intravenous solutions bags, peritoneal dialysis and blood lines sets and warehouse ​ ​ ​ ​ ​ ​ ​ ​ ​ Guadalajara, México 24,234 owned ​ Manufacture of saline, sodium citrate and liquid acids ​ ​ ​ ​ ​ ​ ​ ​ ​ Oita, Japan (Inukai Plant) 24,084 owned ​ Manufacture of fiber bundles ​ ​ ​ ​ ​ ​ ​ ​ ​ Bad Homburg, Germany ​ 15,214 ​ leased ​ December 2026 /December 2029 ​ Corporate headquarters and administration ​ ​ ​ ​ ​ ​ ​ ​ ​ Antalya,Türkiye ​ 22,161 ​ leased ​ December 2037 ​ Manufacture of bloodlines, warehousing and sterilization plant ​ ​ ​ ​ ​ ​ ​ ​ ​ Tijuana, Mexico 22,126 leased May 2029 / September 2026 Manufacturing of NxStage Medical, Inc. (NxStage) System One equipment and related disposables ​ ​ ​ ​ ​ ​ ​ ​ ​ Southaven, Mississippi,U.S. 19,666 leased November 2040 Clinical laboratory testing and administration ​ ​ ​ ​ ​ ​ ​ ​ ​ Rockleigh, New Jersey,U.S. 17,742 leased December 2028 Clinical laboratory testing and administration ​ ​ ​ ​ ​ ​ ​ ​ ​ Reynosa, Mexico 15,746 leased October 2027 Manufacture of bloodlines ​ ​ ​ ​ ​ ​ ​ ​ ​ Vrsac, Serbia 15,365 owned ​ Administration, production and warehouse building ​ ​ ​ ​ ​ ​ ​ ​ ​ Bad Homburg (OE), Germany 10,300 leased / owned December 2026 Manufacture of hemodialysis concentrate solutions / technical services / logistics services ​ We lease most of our dialysis clinics, manufacturing, laboratory, warehousing and distribution, and administrative and sales facilities in the U.S. and other countries on terms which we believe are customary in the industry. We own those dialysis clinics and manufacturing facilities that we do not lease. For information regarding our capital expenditures, see “Item 4.B. Business Overview – Capital Expenditures.”