Fresenius Medical Care AG, a vertically integrated medical technology (MedTech) and health care company, combines medical device engineering and manufacturing expertise with comprehensive patient care.
During 2024, the company divested its service businesses in Chile, Ecuador, Sub-Saharan Africa, Türkiye, Guatemala, Curacao, Peru, Colombia and the Cura Day Hospitals Group in Australia; and the company plans to sell its renal dialysis clinic facilities and/or networks in Brazil, the company’s bu...
Fresenius Medical Care AG, a vertically integrated medical technology (MedTech) and health care company, combines medical device engineering and manufacturing expertise with comprehensive patient care.
During 2024, the company divested its service businesses in Chile, Ecuador, Sub-Saharan Africa, Türkiye, Guatemala, Curacao, Peru, Colombia and the Cura Day Hospitals Group in Australia; and the company plans to sell its renal dialysis clinic facilities and/or networks in Brazil, the company’s business in Kazakhstan and select assets of the company’s wholly owned Spectra Laboratories, all in connection with the Legacy Portfolio Optimization plan.
The company is structured to meet the growing demand for the life-sustaining services and products that are vital to millions of people living with kidney disease worldwide. Kidney patients are individuals with different needs and preferences who require the right therapy, pharmaceuticals, medical technologies and products no matter where they receive treatment, be that in a clinic, hospital, at home or when traveling.
In the company’s two operating segments, Care Delivery and Care Enablement, it provides the full spectrum of healthcare services, systems, devices, technologies, products and pharmaceuticals required to deliver high-quality care to people living with kidney disease around the globe.
Through the company’s vertical integration, scope and scale, it manufactures and distributes kidney-care related medical devices, systems, pharmaceuticals and products to customers across around 150 countries and operate 3,675 dialysis centers throughout around 40 countries worldwide, serving 299,352 dialysis patients. The company manages the world’s largest network of dialysis centers in terms of the number of people treated and operate 39 production sites in 19 countries.
Products and Services
The company receives a substantial portion of its Care Delivery revenue from the U.S. Medicare program and other government sources.
The company also provides 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. The company provides services to these patients either at their bedside, using portable dialysis equipment, or at the hospital’s dialysis site.
Hemodialysis
At the company’s clinics, the company provides 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, the company provides a variety of services to ESRD patients at its 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. The company administers ESAs to most of its patients in the U.S. ESAs have historically constituted a material portion of the company's overall costs of treating its ESRD patients.
Peritoneal Dialysis
For the company’s home dialysis patients, it provides materials, training and patient support services, including clinical monitoring, follow-up assistance and arranging for the delivery of supplies to the patient’s residence.
Care Delivery
Care Delivery encompasses the company’s global network of dialysis clinics and includes services that address the complex health care needs and treatment choices of kidney patients. The company supports the entire spectrum of renal care for CKD and ESRD and is a pioneer in dialysis as kidney replacement therapy.
Within Care Delivery, the company’s value and risk-based care programs allow for partnerships with payors based in the U.S. and the government to reduce the overall cost of care. With the company’s industry expertise, it leverages artificial intelligence, analytics, technological capabilities and platforms to support early interventions in care.
The Fresenius Kidney Care and Fresenius Medical Care NephroCare (NephroCare) dialysis clinic networks comprise the company’s 3,675 worldwide dialysis clinics which provide various forms of in-center kidney replacement therapies. In 2024, the company treated 69% of its patients in the U.S. and 31% in International.
As patients choose greater independence offered by home dialysis, the company provides different options of home dialysis therapy, such as PD and HHD, to meet different patient needs. The company serves over 85,000 patients globally with its PD and HHD solutions.
Although the company’s dialysis clinic network is the heart of Care Delivery, the overall Care Delivery portfolio includes a range of services that meet the immediate and long-term needs of individuals living with kidney disease.
Pharmacy Services
The company offers pharmacy services, mainly in the U.S. These services include providing renal medications and supplies to the homes of patients or to their dialysis clinics directly from renal pharmacists who are specially trained in treating and counseling patients living with kidney disease. The company also produces and distributes kidney-disease related drugs and pharmaceuticals.
Vascular, Cardiovascular, and Endovascular Specialty Services and Vascular Care Ambulatory Surgery Center Services
The company operates physician office-based vascular access centers, mainly in the U.S. It also develops, owns, and manages specialty outpatient ambulatory surgery centers for vascular care. A patient receiving hemodialysis must have a vascular access site to enable blood to flow out of the patient’s body to a dialysis machine for cleansing and to return as newly cleaned blood to the body. The company’s centers create and coordinate the maintenance of these vascular access sites, helping to ensure maturation before use and good flow of blood. Additionally, the company’s vascular care services provide both cardiovascular and endovascular specialty services. Cardiovascular procedures are similar to the setting of care and scope of services for vascular access procedures discussed above, with a focus on treatment for heart disease, while endovascular surgical procedures are minimally invasive and designed to access many regions of the body via major and peripheral blood vessels and assist in both the maintenance of hemodialysis access and treatment of peripheral artery disease.
Value and Risk-Based Care Programs
The company conducts a broad range of value and risk-based care programs spanning chronic kidney disease (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 credit the company periodic, fixed payments based on expected medical expenses of such members. The company has participated recently in the following value-based programs:
CMS commenced its ESRD Treatment Choices model on January 1, 2021. The ESRD Treatment Choices model is a mandatory model that applies to ESRD facilities and managing clinicians in certain randomly selected geographic regions (specifically, Hospital Referral Regions) that comprise approximately 30% of adult ESRD beneficiaries in all 50 states and the District of Columbia. This model applies both upside and downside payment adjustments to certain claims submitted by participating physicians and dialysis facilities for Medicare dialysis patients over a span of six and one-half years.
A voluntary CMS payment model, the Comprehensive Kidney Care Contracting model, builds upon the discontinued ESRD Seamless Care Organizations model. Under the CKCC model, renal healthcare providers participate by forming an entity known as a Kidney Care Entity (KCE). Through the KCE, renal healthcare providers take responsibility for the total cost and quality of care for Medicare beneficiaries with CKD stages 4 and 5, as well as Medicare beneficiaries with ESRD. In order to participate, KCEs must include nephrologists and transplant providers, and dialysis providers and other third parties are permitted to participate. The voluntary models allow KCEs to take on various amounts of financial risk. 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 the assumption of upside risk, but is unavailable to KCEs that include large dialysis organizations.
Value and risk-based care programs with private payors provide care to commercial and Medicare Advantage ESRD and CKD patients. Under these payment arrangements, the company’s financial performance is based on its ability to manage a defined scope of medical costs within certain parameters for clinical outcomes.
Physician Nephrology Services
The company manages and operates nephrology physician practices in the United States.
Ambulant Treatment Services
The company provides ambulant treatment services to a limited extent in parts of its Care Delivery business outside the U.S., which include comprehensive and specialized health check-up centers, vascular access, and other chronic treatment services.
Other Services
Through the company’s Frenova subsidiary, the company 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.
Additionally, the company’s subsidiary, Spectra Laboratories, provides renal-specific laboratory testing and processing.
High-volume Hemodiafiltration
In Europe and the Middle East, the company has been successfully treating patients with high-volume hemodiafiltration (HVHDF) for over 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 European Union-funded CONVINCE study comparing the efficacy of HVHDF against high-flux hemodialysis (HF-HD).
In February 2024, the company’s 5008X hemodialysis system became the first U.S. Food and Drug Administration (FDA)-approved machine capable of delivering HVHDF in the U.S. Paired with the company’s FX CorAL dialyzer, which is already available in the U.S., the 5008X combines advanced engineering and membrane technologies to make HVHDF possible.
In 2024, 62% of NephroCare patients in EMEA were treated with this dialysis technique. In January 2014, NephroCare clinics in EMEA implemented HVHDF (an infusion volume greater than 21 liters per session) as a new quality key performance indicator for patients undergoing post-dilution HDF.
To establish HVHDF as a new standard of care in the U.S. dialysis industry, the company is planning a limited launch to targeted Fresenius Kidney Care clinics during 2025 and a broader commercial launch in 2026 and beyond. HVHDF is expected to benefit both the company’s Care Delivery and Care Enablement segment operations as it will produce new or updated products and provide treatments to its patients using this new modality.
Care Enablement
Care Enablement includes three product verticals: in-center dialysis, home dialysis, and critical care. Each of these units is responsible for the entire product lifecycle, from ideation and creation to value generation, supply chain management, service, and, ultimately, the end of the product’s life.
Products in the company’s Care Enablement portfolio include dialyzers, in-center HD machines, home dialysis and PD cyclers, PD solutions, HD concentrates, solutions and granulates, bloodlines, renal pharmaceuticals, systems for water treatment, acute cardiopulmonary products, apheresis products, and other medical devices. Care Enablement also conducts MedTech device and pharmaceutical-related research and development (R&D) and includes manufacturing, supply chain, and commercial operations.
The healthcare products the company offers in around 150 countries worldwide focus on the following therapies:
Hemodialysis – The company provides a wide range of HD systems in dialysis centers, as well as for use at home, including machines, dialyzers, bloodline systems, HD solutions, and concentrates, water treatment systems, as well as data processing and analysis systems.
Peritoneal Dialysis – The company offers systems and solutions for CAPD and APD in dialysis centers, as well as for use at home.
Acute Dialysis – The company’s portfolio includes acute dialysis machines, dialysis fluids, hemofilters, plasma filters, adsorbers, and a variety of treatment kits and catheters.
The portfolio includes both dialysis machines and dialyzer options for kidney replacement therapies across a wide range of clinical needs, including low flux dialysis, high flux dialysis, HDF, and HVHDF.
With a comprehensive home dialysis portfolio, including both PD and HHD, the company has a clear focus on this growth market. The company is making significant progress in connected health solutions with a strong presence in the U.S. and ongoing expansion across Europe, the Middle East, and Africa (EMEA).
The company also offers extracorporeal therapy options for patients who cannot be sufficiently treated through conventional pharmaceutical regimens, including the removal of metabolic products, toxins, autoantibodies, and immunocomplexes.
The company is the world’s largest manufacturer and distributor of equipment and related products for hemodialysis and the second largest manufacturer and distributor of peritoneal dialysis products. For the fiscal year 2024, health care products accounted for 22% of the company’s consolidated total revenue.
In December 2016, the company acquired Xenios AG (Xenios), expanding its capability to multi-organ support. The 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 (ECMO) system to be cleared for more than six hours of continuous use as extracorporeal life support.
Renal Pharmaceuticals
The company continues to acquire and in-license renal pharmaceuticals to improve dialysis treatment for its patients. Below are the primary renal pharmaceuticals the company has acquired or for which it has obtained licenses for use:
PhosLo
In November 2006, the company 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 phosphorus out of the body. The company has 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 the company’s PhosLo sales in 2009. In October 2009, the company launched an authorized generic version of PhosLo to compete in the generic calcium acetate market. In April 2011, the FDA approved the company’s New Drug Application for Phoslyra, a liquid formulation of PhosLo. In 2023, the company discontinued the sale of Phoslyra in the U.S.
Venofer and Ferinject
In 2008, the company 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, and one for the U.S. (with American Regent, 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, an intravenous iron brand in terms of volume worldwide. Ferinject is an intravenous iron therapy with market authorization in various countries as of October 2024 and more than 30 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 the company’s 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, the company announced the expansion of its 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, such as 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.
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). Fresenius Medical Care North America (FMCNA) markets 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. Velphoro has been approved in several countries and commercially launched in some 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, the company received New Drug Approval in February 2023.
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 its shared product portfolio, VFMCRP acquired nephrology medicines commercialized by the company, 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.
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 management, 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 symptomatic anemia associated with chronic kidney disease. The product is 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 U.S. 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) licensed 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 combination with a rituximab or cyclophosphamide regimen in Japan, 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 Germany, Austria, Japan, Canada, Great Britain, Switzerland, Luxembourg, France, Spain, Finland, the Netherlands, Italy, Israel, the United Arab Emirates, Saudi Arabia, Kuwait, Ireland, Australia, and Greece.
Korsuva/Kapruvia (difelikefalin) is the first product approved in the EU and the U.S. for the treatment of moderate-to-severe pruritus associated with CKD for adults undergoing hemodialysis. VFMCRP has a license agreement with Cara Therapeutics, Inc. (Cara), to develop and commercialize Korsuva/Kapruvia worldwide, excluding Japan and South Korea. Recently, CSL Vifor entered into discussions with Cara related to a potential acquisition of Korsuva/Kapruvia by CSL Vifor or one of its affiliates. In the U.S., VFMCRP’s rights are for the entire dialysis market. The company’s renal pharmaceuticals team promotes the product to its clinics/prescribers and receives a marketing fee on its clinical sales, as well as group profit (as a shareholder of VFMCRP) for non-Fresenius Medical Care sales. CSL Vifor’s sales team promotes the product to all non-Fresenius Medical Care clinics/prescribers and receives a marketing fee on these sales. In 2023, CMS ruled that it would add to each Medicare Fee-for-Service patient treatment beginning in April 2024 through the end of 2024. Fresenius Renal Pharmaceuticals and CSL Vifor agreed that both organizations would stop the promotion of Korsuva in the U.S. market in 2024. Korsuva/Kapruvia is approved in the U.S., the EU (including Iceland, Liechtenstein, and Norway), Great Britain, Canada, Switzerland, Kuwait, the United Arab Emirates, Singapore, and Australia. The product is available in the U.S., Germany, Austria, Sweden, France, Netherlands, Iceland, Ireland, Switzerland, the U.K., Finland, Norway, Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, the United Arab Emirates, Singapore, Canada, and Luxembourg.
VFMCRP also owns the rights to Veltassa (patiromer), a treatment for hyperkalemia or elevated potassium levels, outside of the U.S. and Japan. In the licensed territories, Veltassa was launched in various European markets, as well as Israel, Saudi Arabia, the United Arab Emirates, Kuwait, Australia, and Canada (by partner Otsuka Canada Pharmaceutical, Inc.).
Competition
Health Care Services
The company’s largest competitors in the dialysis services industry include DaVita, Inc., Diaverum AB, B. Braun SE, U.S. Renal Care, Inc. and Nephrocare Health Services Private Limited (NephroPlus).
Products
The company’s competitors include Akebia Therapeutics, Inc.; Ardelyx Inc.; Asahi Kasei Medical Co., Ltd; B. Braun SE; Bain Medical Equipment (Guangzhou) Co., Ltd; Baxter International, Inc.; JMS Co., Ltd; Mozarc Medical Holding LLC; Nikkiso Co., Ltd.; Nipro Corporation; Outset Medical, Inc.; Quanta Dialysis Technologies Inc.; Sanofi S.A.; Physidia SAS; Takeda Pharmaceutical Company Limited; Toray Medical Co., Ltd.; and Shandong Weigao Blood Purification Products Co., Ltd.
Strategy
The company’s products and health care services are at the core of its strategy.
The company is leveraging its core strategic competencies: developing innovative products, operating outpatient facilities, standardizing medical procedures and coordinating patient care effectively.
Legacy Portfolio Optimization
As part of the company’s strategic execution, the company has made significant progress in its Legacy Portfolio Optimization program, which is a key lever for unlocking value and focusing on core business areas, which involves the review of its assets to assess growth potential and scalability.
In connection with the company’s Legacy Portfolio Optimization program in its Care Delivery segment, the company signed or closed divestments of its activities in all its Latin American markets and the company successfully closed divestments of subsidiaries in Sub-Saharan Africa, Türkiye, and the Cura Day Hospitals Group in Australia in 2024.
In Care Enablement, the company is optimizing its product portfolio by refocusing R&D on future platforms and assessing the strategic fit of its Fresenius Medical Care Ventures portfolio.
Customers, Marketing, Distribution, and Service
The company sells most of its products to dialysis clinics, hospitals, and other specialized treatment clinics. A synergistic relationship among the company’s sales, marketing, and R&D personnel enables real-world insights from the field to be incorporated into its product development process. The company maintains 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 the company at industry events, while its clinical nurses provide support, training, and assistance to customers. The company offers 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 it sells dialysis products.
The company’s distribution network is designed for efficiency, with products moving from factories to central warehouses, then to regional facilities. The company also provides direct-to-patient delivery for home dialysis products and offers direct shipping to healthcare facilities for certain product lines. To maximize its reach, the company employs a combination of local sales forces, independent distributors, dealers, and sales agents to ensure its products are accessible worldwide.
Sales of Dialysis Products to Iran
The company allocated resources to design, implement, and maintain a compliance program specific to its U.S. and non-U.S. activities. Additionally, the company’s dedication to providing 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.
During the year ended December 31, 2024, the company sold 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 and parts, and related disposable supplies. The sales of these products generated operating income for the year ended December 31, 2024. All such sales were made by the company’s German subsidiaries.
Production
The company operates modern development, production and distribution facilities worldwide to meet the demand for its dialysis products and other health care products.
The company produces and assembles hemodialysis machines and peritoneal dialysis cyclers in Germany and in Mexico. The company manufactures and assembles dialyzers and polysulfone membranes in the U.S., Germany, France, and Japan. The company also produces and assembles hemodialysis machines and dialyzers in China. The company manufactures hemodialysis concentrate products and PD solutions at various facilities worldwide. Additionally, the company manufactures bloodlines in Mexico, China, Türkiye, and Serbia. Home hemodialysis products and components are produced in Italy, Germany, and Mexico.
Patents and Patent Licenses
As the owner of patents or licensee under patents throughout the world, the company holds rights in over 9,500 patents and patent applications in major markets.
Trademarks
As the owner of trademarks or licensee under trademarks throughout the world, the company holds rights in over 3,600 registered trademarks or trademark applications covering inter alia its key product branding in major markets.
The company’s principal trademarks and corporate names are or comprise the designation ‘Fresenius Medical Care,’ which it uses stand-alone or together with a triangular ‘F’ figure in its corporate logo. The use of ‘Fresenius’ in the company’s trademarks is based on a perpetual, royalty-free license from Fresenius SE, its major shareholder. The Trademark License Agreement remains in full force after the company’s Conversion and related deconsolidation from Fresenius SE, with some amendments/clarification concerning, inter alia, standards regarding the use of the ‘Fresenius Marks,’ limits on the stand-alone use of the ‘Fresenius’ name by the company, the introduction of customary termination rights for good cause, and the introduction of reporting obligations regarding any harmful use of the Licensed Marks and/or the ‘Fresenius’ name.
Regulatory and Legal Matters
The company must comply with all the U.S., German, and other legal and regulatory requirements under which it operates, 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 health care company, the company is 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 the 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 the company’s global data protection and security compliance programs.
In the U.S., numerous regulatory bodies, including the FDA and comparable state regulatory agencies impose requirements on certain of the company’s subsidiaries as a manufacturer, distributor and/or a seller of drug products under their respective jurisdictions. Some of the products the company’s 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 the company’s 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.
The company’s pharmaceutical products must be manufactured in accordance with current Good Manufacturing Practices (cGMP). The company is required to provide information to the FDA whenever it becomes aware of a report of an adverse drug experience associated with the use of one of its drug products that is both serious and unexpected, as defined in FDA regulations and guidance. The company is required to notify the FDA of certain product quality issues. Furthermore, the FDA prohibits the company’s products division from marketing or promoting its pharmaceutical products in a false or misleading manner and from otherwise misbranding or adulterating them.
The company’s 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, the company is 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. The company is subject to periodic inspection by the FDA for compliance with these requirements. With respect to manufacturing, the company is subject to FDA’s Quality System Regulation (21 C.F.R. Part 820) and related FDA guidance, which requires the company to manufacture products in accordance with cGMP, including standards governing product design.
The company’s 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.
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 the company 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.
The company’s operations are subject to various U.S. Department of Transportation, Nuclear Regulatory Commission, Environmental Protection Agency, and OSHA requirements, as well as other federal, state, and local hazardous and medical waste disposal laws.
The company participates 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. The company makes its 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 the company’s license to market and distribute the intravenous iron medication Venofer to freestanding dialysis clinics, the company is also considered, for statutory price reporting purposes, to be the manufacturer of Venofer (when sold by the company under one of its national drug codes (NDCs)), which is reimbursed under Part B of the Medicare program. The company’s 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.
The Medicaid rebate amount is computed each quarter based on the company’s submission to CMS of its current Average Manufacturer Price and Best Price for its pharmaceutical products. The Veterans Health Care Act imposes a requirement that the prices the company charges 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. Since Venofer is covered under Part B, the company is responsible for compiling and utilizing a wide range of sales data elements to determine the ASP of Venofer marketed under its NDCs and reporting it to CMS. The Medicare ESRD PPS system incorporates payment for Venofer at dialysis facilities.
Some of the company’s 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. The company’s operations are also subject to federal statutes that govern the relationships and assistance that it may provide to its 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.
History
Fresenius Medical Care AG was founded in 1996. The company was incorporated in 1996.
