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What changed in Fresenius Medical Care AG's 20-F2024 vs 2025

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Paragraph-level year-over-year comparison of Fresenius Medical Care AG's 2024 and 2025 20-F annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+1208 added1204 removedSource: 20-F (2026-02-24) vs 20-F (2025-02-25)

Top changes in Fresenius Medical Care AG's 2025 20-F

1208 paragraphs added · 1204 removed · 806 edited across 5 sections

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

95 edited+20 added26 removed135 unchanged
Biggest changeFor the fiscal year ended December 31, 2024, approximately 18% of our consolidated revenues resulted from Medicare and Medicaid (excluding Medicare Advantage) reimbursement. The Medicare and Medicaid programs change their payment methodologies and funding from time to time in ways that are driven by changes in statute, economic conditions, and policy.
Biggest changeThe Medicare and Medicaid programs change their payment methodologies and funding from time to time in ways that are driven by changes in statute, economic conditions, and policy, but do not always keep pace with cost increases. For example, the Budget Control Act of 2011 (BCA) required a $1.2 trillion reduction in deficits through 2021.
For further information, see the table “U.S. patient service revenue” detailing the percentage generated from government reimbursement and private payors in the U.S. in Item 4B, “Information on the Company Business overview.” Any of the following events, among others, could have a material adverse impact on our business, financial condition and results of operations: we may be subject to rejections of or reductions in reimbursement from private payors, including, for example, through their use of lower allowed charges rather than rates based on our billed charges; we may experience a reduction in our ability to obtain and retain commercially insured patients to utilize our health care services; efforts by private payors to continue to control the cost of and/or the eligibility for access to health care services, including relative to insurance products on and off the health care exchanges established by the ACA and potential efforts by employer group health plans and commercial insurers to limit benefits or reduce reimbursement for our services or eliminate reimbursement for some of our services; a portion of our business that is currently reimbursed by private insurers or hospitals may become reimbursed by integrated care organizations, which may use payment methodologies that reduce reimbursement for our services.
For further information, see the table “U.S. patient service revenue” detailing the percentage generated from government reimbursement and private payors in the U.S. in Item 4B, “Information on the Company Business overview.” Any of the following events, among others, could have a material adverse impact on our business, financial condition, and results of operations: we may be subject to rejections of or reductions in reimbursement from private payors, including, for example, through their use of lower allowed charges rather than rates based on our billed charges; we may experience a reduction in our ability to obtain and retain commercially insured patients to utilize our healthcare services; efforts by private payors to continue to control the cost of and/or the eligibility for access to healthcare services, including relative to insurance products on and off the healthcare exchanges established by the ACA and potential efforts by employer group health plans and commercial insurers to limit benefits or reduce reimbursement for our services or eliminate reimbursement for some of our services; a portion of our business that is currently reimbursed by private insurers or hospitals may become reimbursed by integrated care organizations, which may use payment methodologies that reduce reimbursement for our services.
Devaluation of currencies such as the impact from hyperinflationary economies as well as fluctuations in currencies as a result of geopolitical conflicts, unfavorable interest rate changes and worsening economic conditions, uncertainty arising from geopolitical conflicts regarding a possible deterioration of the global macroeconomic outlook, including inflationary cost increases in various markets in connection with deteriorating country credit ratings increase the risk of a goodwill impairment, which could lead to a partial or total goodwill write-off in the affected cash generating units, or have a negative impact on our investments and external partnerships.
Devaluation of currencies such as the impact from hyperinflationary economies as well as fluctuations in currencies as a result of geopolitical conflicts, unfavorable interest rate changes and uncertainty regarding the direction of such changes, worsening economic conditions, uncertainty arising from geopolitical conflicts regarding a possible deterioration of the global macroeconomic outlook, including inflationary cost increases in various markets in connection with deteriorating country credit ratings increase the risk of a goodwill impairment, which could lead to a partial or total goodwill write-off in the affected cash generating units, or have a negative impact on our investments and external partnerships.
There are significant risks associated with estimating the amount of revenues from health care services that we recognize in a reporting period. The billing and collection process is complicated due to a number of factors including insurance coverage changes, geographic coverage differences, differing interpretations of plan benefits and managed care contracts, and uncertainty about reimbursement from payors with whom we are not contracted. Laws and regulations governing Medicare, Medicaid and other federal programs are extremely complex, changing and subject to interpretation. Determining applicable primary and secondary insurance coverage for an extensive number of patients at any point in time, together with the changes in patient coverage that occur each month or changes in plan benefits, requires complex, resource-intensive processes.
There are significant risks associated with estimating the amount of revenues from healthcare services that we recognize in a reporting period. The billing and collection process is complicated due to a number of factors including insurance coverage changes, geographic coverage differences, differing interpretations of plan benefits and managed care contracts, and uncertainty about reimbursement from payors with whom we are not contracted. Laws and regulations governing Medicare, Medicaid and other federal programs are extremely complex, changing, and subject to interpretation. Determining applicable primary and secondary insurance coverage for an extensive number of patients at any point in time, together with the changes in patient coverage that occur each month or changes in plan benefits, requires complex, resource-intensive processes.
In response, many state departments of insurance either allowed or required insurers to mitigate their losses by increasing the 2018 premiums on their ACA plans. Many insurers also mitigated the impact to themselves by “silver loading,” a practice whereby the premiums for silver-level plans were increased to offset the loss of CSR payments.
In response, many state departments of insurance either allowed or required insurers to mitigate their losses by increasing the 2018 premiums on their ACA plans. Many insurers also mitigated the impact to themselves by silver loading, a practice whereby the premiums for silver-level plans were increased to offset the loss of CSR payments.
A failure of any of our single-source suppliers to fulfil their contractual obligations in a timely manner or as a result of regulatory noncompliance or physical disruption at a manufacturing site could adversely affect our ability to manufacture and distribute our products in a timely or cost-effective manner, and our ability to make product sales.
The failure of any of our single-source suppliers to fulfil their contractual obligations in a timely manner or as a result of regulatory noncompliance or physical disruption at a manufacturing site could adversely affect our ability to manufacture and distribute our products in a timely or cost-effective manner, and our ability to make product sales.
In addition, options to restructure the Medicare program in the direction of a defined contribution, “premium support” model and to shift Medicaid funding to a block grant or per capita arrangement, with greater flexibility for the states, have been proposed or considered from time to time.
In addition, options 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 been proposed or considered from time to time.
Any future government shutdown, government default on debt, decline in government revenues during a prolonged economic slowdown and/or failure of governments to enact annual appropriations could have a material adverse impact on our business, financial condition and results of operations.
Any government shutdown, government default on debt, decline in government revenues during a prolonged economic slowdown and/or failure of governments to enact annual appropriations could have a material adverse impact on our business, financial condition, and results of operations.
On a country level, the payor base is characterized by distinct customer or payor groups which can range in volume from a few customers to a considerable amount of customer types which have varying levels of risk associated with default or non-payment of receivables as well as risks for dependencies based upon the competition within low volume customer base environments.
On a country level, the customer and payor mix is characterized by distinct customer or payor groups which can range in volume from a few customers to a considerable amount of customer types which have varying levels of risk associated with default or non-payment of receivables as well as risks for dependencies based upon the competition within low volume customer base environments.
Proposals for legislative reform in these countries are often introduced to improve access to care, address quality of care issues and manage costs of the health care system. In the U.S., there have been efforts to pursue significant changes to existing health care programs, including efforts to repeal or replace the ACA which, while unsuccessful to date, continue.
Proposals for legislative reform in these countries are often introduced to improve access to care, address quality of care issues and manage costs of the healthcare system. In the U.S., there have been efforts to pursue significant changes to existing healthcare programs, including efforts to repeal or replace the ACA which, while unsuccessful to date, continue.
Cyber-attacks or other privacy and data security incidents could disrupt our business and expose us to significant losses, liability and reputational damage. We and our third-party service providers routinely process, store and transmit large amounts of data in our operations, including sensitive personal information as well as proprietary or confidential information relating to our business or third parties.
Cyber-attacks or other privacy and data security incidents could disrupt our business and expose us to significant losses, liability, and reputational damage. We and our third-party service providers routinely process, store and transmit substantial amounts of data in our operations, including sensitive personal information as well as proprietary or confidential information relating to our business or third parties.
Physicians may change their recommendations, which may result in the movement of new or existing patients to competing facilities, including facilities established by the physicians themselves. At most of our dialysis clinics and home programs, a relatively small number of physicians often account for the referral of all or a significant portion of the patient base.
Physicians may change their recommendations, which may result in the movement of new or existing patients to competing facilities, including facilities established by the physicians themselves. At most of our dialysis clinics and home programs, a relatively small number of physicians often account for the referral of all or a sizable portion of the patient base.
These include, in particular, loss or suspension of federal certifications, loss or suspension of licenses under the laws of any state or governmental authority from which we generate substantial revenues, monetary and administrative penalties, product recalls, increased costs for compliance with government orders, complete or partial exclusion from government reimbursement programs, refunds of payments received from government payors and government health care program beneficiaries due to failures to meet applicable requirements or complete or partial curtailment of our authority to conduct business.
These include, in particular, loss or suspension of federal certifications, loss or suspension of licenses under the laws of any state or governmental authority from which we generate substantial revenues, monetary and administrative penalties, product recalls, increased costs for compliance with government orders, complete or partial exclusion from government reimbursement programs, refunds of payments received from government payors and government healthcare program beneficiaries due to failures to meet applicable requirements, or complete or partial curtailment of our authority to conduct business.
There can be no assurance that we can achieve future price increases from private insurers and integrated care organizations offering private insurance coverage to our patients; 8 Table of Contents if legislative or regulatory efforts or litigation to restrict or eliminate the charitable funding of patient insurance premiums are successful, our patients with coverage under publicly funded programs like Medicare may be unable to continue to pay the premiums for that coverage and may become uninsured for dialysis services.
There can be no assurance that we can achieve future price increases from private insurers and integrated care organizations offering private insurance coverage to our patients; if legislative or regulatory efforts or litigation to restrict or eliminate the charitable funding of patient insurance premiums are successful, our patients with coverage under publicly funded programs like Medicare may be unable to continue to pay the premiums for that coverage and may become uninsured for dialysis services.
While the availability of telehealth services is convenient and improves access to medical care, increased reliance on, and utilization of, telemedicine for delivery of health care services could also increase the risk of privacy violations and our vulnerability to data breaches and cyber-attacks.
While the availability of telehealth services is convenient and improves access to medical care, increased reliance on, and utilization of, telemedicine for delivery of healthcare services could also increase the risk of privacy violations and our vulnerability to data breaches and cyber-attacks.
The reserves that we establish in connection with the operation of our value and risk-based care programs are based upon assumptions and judgments concerning a number of factors, including trends in health care costs, expenses, patient hospitalization rates and other factors.
The reserves that we establish in connection with the operation of our value and risk-based care programs are based upon assumptions and judgments concerning a number of factors, including trends in healthcare costs, expenses, patient hospitalization rates and other factors.
If we do not comply with the numerous governmental regulations applicable to our business, we could suffer adverse legal consequences, including exclusion from government health care programs or termination of our authority to conduct business, any of which would result in a material decrease in our revenue; this regulatory environment also exposes us to claims and litigation, including “whistleblower” suits.
If we do not comply with the numerous governmental regulations applicable to our business, we could suffer adverse legal consequences, including exclusion from government healthcare programs or termination of our authority to conduct business, any of which would result in a material decrease in our revenue; this regulatory environment also exposes us to claims and litigation, including “whistleblower” suits.
The DOJ and SEC have accepted the Monitor’s certification and the NPA and SEC Order expired on March 1, 2023 and March 29, 2023, respectively.
The DOJ and SEC accepted the Monitor’s certification and the NPA and SEC Order expired on March 1, 2023 and March 29, 2023, respectively.
Any failure of these measures to mitigate disruptive goods shortages and potential price increases or to allow access to favorable new product and technology developments could have an adverse impact on our business and financial condition.
Any failure of these measures to mitigate disruptive goods shortages and potential price increases or to allow access to favorable new product and technological developments could have an adverse impact on our business and financial condition.
We operate dialysis facilities or manufacturing facilities in many regions of the world, with diverse geographic, societal, political and economic conditions and we are subject to unpredictable events beyond our control such as natural disasters, terrorist attacks, social unrest or public health crises such as epidemics or pandemics from, for example, virus infections.
We operate dialysis and manufacturing facilities and provide other services in many regions of the world, with diverse geographic, societal, political and economic conditions and we are subject to unpredictable events beyond our control such as natural disasters, terrorist attacks, social unrest or public health crises such as epidemics or pandemics from, for example, virus infections.
Risks relating to our business activities and industry If physicians and other referral sources cease referring patients to our health care service businesses and facilities or cease purchasing or prescribing our products, our revenues would decrease. In providing services within our health care business, we depend upon patients choosing our health care facilities as the location for their care.
Risks relating to our business activities and industry If physicians and other referral sources cease referring patients to our healthcare service businesses and facilities or cease purchasing or prescribing our products, our revenues would decrease. In providing healthcare services, we depend upon patients choosing our healthcare facilities as the location for their care.
Life-sustaining health care products are usually not subject to trade sanctions/export controls. However, as a result of the escalation of EU, U.S. and other countries’ trade sanctions targeting Russia and Belarus, certain spare parts and components for our products fall under product categories subject to restrictions.
Life-sustaining healthcare products are usually not subject to trade sanctions/export controls. However, as a result of the escalation of EU, U.S., and other countries’ trade sanctions targeting Russia and Belarus, certain spare parts and components for our products fall under product categories subject to restrictions.
Risks relating to legal and regulatory matters We operate in a highly regulated industry such that the potential for legislative reform provides uncertainty and potential threats to our operating models and results. The delivery of health care services and products is highly regulated in virtually every country in which we operate.
Risks relating to legal and regulatory matters We operate in a highly regulated industry such that the potential for legislative reform provides uncertainty and potential threats to our operating models and results. The delivery of healthcare services and products is highly regulated in virtually every country in which we operate.
We have seen challenges in the labor market, in particular in the U.S., resulting in staff shortages, high turnover rates and meaningfully higher costs, which have and could continue to impact our growth, specifically in U.S. health care services where labor constraints affected our ability to increase treatment volumes.
We have seen challenges in the labor market, in particular in the U.S., resulting in staff shortages, high turnover rates and meaningfully higher costs, which have and could continue to impact our growth, specifically in U.S. healthcare services where labor constraints affected our ability to increase treatment volumes.
Any or all of these factors generally could have an adverse effect on our business, financial condition and results of operations. For further discussion on the impacts to our business in 2024 (see Item 5. “Operating and financial review and prospects III. Results of operations, financial position and net assets”).
Any or all of these factors could have an adverse effect on our business, financial condition, and results of operations. For further discussion on the impacts to our business in 2025 (see Item 5. “Operating and financial review and prospects III. Results of operations, financial position and net assets”).
Foreign Corrupt Practices Act and similar worldwide anti-corruption laws. The U.S. FCPA and similar worldwide anti-corruption laws generally prohibit companies and their intermediaries from making improper payments to public officials for the purpose of obtaining or retaining business. Our internal policies mandate compliance with these anti-corruption laws. We operate many facilities throughout the U.S. and other parts of the world.
FCPA and similar worldwide anti-corruption laws generally prohibit companies and their intermediaries from making improper payments to public officials for the purpose of obtaining or retaining business. Our internal policies mandate compliance with these anti-corruption laws. We operate many facilities throughout the U.S. and other parts of the world.
Risks relating to taxation and accounting There are significant risks associated with estimating the amount of health care service revenues that we recognize that could impact the timing of our recognition of revenues or have a significant impact on our operating results and financial condition.
Risks relating to taxation and accounting There are significant risks associated with estimating the amount of healthcare service revenues that we recognize that could impact the timing of our recognition of revenues or have a significant impact on our operating results and financial condition.
Our global operations are subject to a number of risks, including but not limited to the following: the economic and political situation in certain countries or regions could deteriorate, become unstable, or lead to armed conflict, as exemplified by the Ukraine War; 13 Table of Contents geopolitical factors could intensify fluctuations in exchange rates, currency devaluations, and/or material increases in interest rates (for example, as a reaction from central banks to high inflation), any of which could adversely affect profitability and all of which have been heightened by the Ukraine War; sovereign rating agency downgrades coupled with an economic downturn in various regions or as a result of geopolitical conflicts in certain regions (for example, the Ukraine War) could result in impairment of our goodwill, investments or other assets due to decreases in the recoverable amount of those assets relative to their book value; we could face difficulties in enforcing and collecting accounts receivable under some countries’ legal systems; local regulations could restrict our ability to obtain a direct ownership interest in dialysis clinics or other operations; some countries or economic unions may impose charges or restrictions, such as local content requirements, which restrict the importation of our products or give local manufacturers an advantage in tenders or provide large discounts to providers for certain purchases of our products; potential increases in tariffs and trade barriers could occur affecting both the sale of our products and importation of products and product components, including upon any withdrawal by the U.S. or other countries from multilateral trade agreements, or the imposition of sanctions, retaliatory tariffs and other countermeasures in the wake of trade disputes and geopolitical conflicts and wars in certain regions (for example the Ukraine War); we could experience transportation delays or interruptions or higher energy costs or energy shortages; growth and expansion into emerging markets could cause us difficulty due to greater regulatory barriers than in the U.S. or Western Europe, the necessity of adapting to new regulatory systems, and problems related to entering new markets with different economic, social, legal and political systems and conditions; and we may not prevail in competitive contract tenders.
Our global operations are subject to a number of risks, including but not limited to the following: the economic and political situation in certain countries or regions could deteriorate, become unstable, or lead to armed conflict, as exemplified by the Ukraine War; geopolitical factors could intensify fluctuations in exchange rates, currency devaluations, and/or material increases in interest rates (for example, as a reaction from central banks to high inflation), any of which could adversely affect profitability and all of which have been heightened by the Ukraine War; sovereign rating agency downgrades coupled with an economic downturn in various regions or as a result of geopolitical conflicts in certain regions (for example, the Ukraine War) could result in impairment of our goodwill, investments or other assets due to decreases in the recoverable amount of those assets relative to their book value; we could face difficulties in enforcing and collecting accounts receivable under some countries’ legal systems; local regulations could restrict our ability to obtain a direct ownership interest in dialysis clinics or other operations; some countries or economic unions may impose charges or restrictions, such as local content requirements, which restrict the importation of our products or give local manufacturers an advantage in tenders or provide large discounts to providers for certain purchases of our products; economic uncertainty resulting from the imposition of tariffs and proposals to impose tariffs (including, in each case, reciprocal retaliatory tariffs), and deferrals, modifications, and withdrawals of such tariffs and proposals, as well as actual increases in tariffs and trade barriers could affect both the sale of our products and importation of products and product components, including upon any withdrawal by the U.S. or other countries from multilateral trade agreements, or the imposition of sanctions, retaliatory tariffs and other countermeasures in the wake of trade disputes and geopolitical conflicts and wars in certain regions (for example the Ukraine War); we could experience transportation delays or interruptions or higher energy costs or energy shortages; growth and expansion into emerging markets could cause us difficulty due to greater regulatory barriers than in the U.S. or Western Europe, the necessity of adapting to new regulatory systems, and problems related to entering new markets with different economic, social, legal, and political systems and conditions; and we may not prevail in competitive contract tenders.
Health care products may also be subject to recalls, statutory or regulatory shipping holds and intellectual property rights (for example patents or trademarks) infringement claims which, in addition to monetary penalties, may restrict our ability to sell or use our products.
Healthcare products may also be subject to recalls, statutory or regulatory shipping holds and intellectual property rights (for example patents or trademarks) infringement claims which, in addition to monetary penalties, may restrict our ability to sell or use our products.
Failure to effectively identify, carry out and manage the necessary sustainability and related reporting activities as required or expected, as well as effectually manage the impact of factors beyond our control, could cause us to incur additional costs or damage our brand.
Failure to effectively identify, conduct and manage the necessary sustainability and related reporting activities as required or expected, as well as effectually manage the impact of factors beyond our control, could cause us to incur additional costs or damage our brand.
Health care companies are typically subject to claims alleging negligence, product liability, breach of warranty, malpractice and other legal theories that may involve large claims and significant defense costs whether or not liability is ultimately imposed.
Healthcare companies are typically subject to claims alleging negligence, product liability, breach of warranty, malpractice and other legal theories that may involve large claims and significant defense costs whether or not liability is ultimately imposed.
By virtue of its ownership of approximately 32.2% of our share capital, Fresenius SE therefore has a de facto veto right over any such resolution or resolutions if and when proposed for adoption by our shareholders.
By virtue of its ownership of our share capital, Fresenius SE therefore has a de facto veto right over any such resolution or resolutions if and when proposed for adoption by our shareholders.
A number of the dialysis clinics and health care centers that we operate are owned, or managed, by entities in which one or more hospitals, physicians or physician practice groups hold an interest.
A number of the dialysis clinics and healthcare centers that we operate are owned, or managed, by entities in which one or more hospitals, physicians or physician practice groups hold an interest.
The health care industry experiences continuing consolidation, particularly among health care providers, as well as pressure on reimbursement and increasing costs, which requires us to identify both growth opportunities and efficiencies in the way we operate.
The healthcare industry experiences continuing consolidation, particularly among healthcare providers, as well as pressure on reimbursement and increasing costs, which requires us to identify both growth opportunities and efficiencies in the way we operate.
We could also be required to repay to Medicare, Medicaid as well as other federal health care program amounts pursuant to any prohibited referrals, and we could be subject to criminal and monetary penalties and exclusion from federal and state health care programs.
We could also be required to repay Medicare, Medicaid as well as other federal healthcare program amounts pursuant to any prohibited referrals, and we could be subject to criminal and monetary penalties and exclusion from federal and state healthcare programs.
Additionally, material disruptions in government operations may negatively impact regulatory approvals and guidance that are important to our operations and create uncertainty about the pace of upcoming health care regulatory developments.
Additionally, material disruptions in government operations may negatively impact regulatory approvals and guidance that are important to our operations and create uncertainty about the pace of upcoming healthcare regulatory developments.
An inability to protect our intellectual property in these countries could have an adverse effect on our business, results of operations and financial condition. 14 Table of Contents We conduct humanitarian-related business and provide life-sustaining health care products and services directly or indirectly in sanctioned countries, such as Russia, Belarus, Iran and Syria.
An inability to protect our intellectual property in these countries could have an adverse effect on our business, results of operations and financial condition. 13 Table of Contents We conduct humanitarian-related business and provide life-sustaining healthcare products and services directly or indirectly in sanctioned countries, such as Russia, Belarus, Iran, and Syria.
Global economic conditions as well as disruptions in financial markets could have an adverse effect on our businesses. We are dependent on the conditions of the financial markets and the global economy. In order to pursue our business, we are reliant on capital markets, as are our renal product customers and commercial health care insurers.
Global economic conditions as well as disruptions in financial markets could have an adverse effect on our businesses. We are dependent on the conditions of the financial markets and the global economy. To pursue our business, we are reliant on capital markets, as are our renal product customers and commercial healthcare insurers.
Any or all of these factors, or other consequences of the continuation, or worsening, of domestic and global economic conditions which cannot currently be predicted, could continue to have a material adverse effect on our businesses and results of operations. 17 Table of Contents We could be adversely affected if we experience shortages of goods or material price increases from our suppliers, or an inability to access new and improved products and technology.
Any or all of these factors, or other consequences of the continuation, or worsening, of domestic and global economic conditions could continue to have a material adverse effect on our businesses and results of operations. 16 Table of Contents We could be adversely affected if we experience shortages of goods or material price increases from our suppliers, or an inability to access new and improved products and technology.
A substantial portion of our revenues depends on government health care program reimbursement, and any disruptions in government operations could have a material adverse impact on our business, financial condition and results of operations.
A substantial portion of our revenues depends on government healthcare program reimbursement, and any disruptions in government operations could have a material adverse impact on our business, financial condition, and results of operations.
In certain cases, a resulting dependency on the payment behavior and decision-making of our business partners (for example, a decision to discontinue tender contracts) can affect the collectability of accounts receivable and can adversely affect our business, results of operations and financial condition.
In certain cases, a resulting dependency on the payment behavior and decision-making of our business partners (for example, a decision to discontinue tender contracts or high-volume customer contracts) can affect the collectability of accounts receivable and can adversely affect our business, results of operations and financial condition.
For information on the value-based programs in which we participate, see Item 4B, “Information on the Company Business overview Other health care services Value and risk-based care programs.” Our profitability in our value-based agreements and risk products depends in part upon our ability to negotiate favorable financial terms, to manage a patient’s care, to collaborate with our payor partners, to coordinate with other health care providers, to accurately document patients’ health conditions for risk adjustment, and to find cost efficient, medically appropriate sites of service for our patients.
For information on the value-based programs in which we participate, see Item 4B, “Information on the Company Business overview Value-Based Care” and “— Regulatory and Legal Matters Reimbursement.” Our profitability in our value-based agreements and risk products depends in part upon our ability to negotiate favorable financial terms, to manage a patient’s care, to collaborate with our payor partners, to coordinate and collaborate effectively with other healthcare providers, to accurately document patients’ health conditions for risk adjustment, and to find cost efficient, medically appropriate sites of service for our patients.
Failure to realize the expected cost savings from the FME25 Program within our announced timeframe described above could adversely impact the market for our securities and availability of financing, which, in addition, could limit our future growth, including growth in either our revenues or earnings within our health care services and products businesses.
Failure to realize the expected cost savings from the FME25+ Program within our announced timeframe described above could adversely impact the market for our securities and availability of financing, which, in addition, could limit our future growth, including growth in either our revenues or earnings.
GLP-1 receptor agonist utilization together with sodium-glucose cotransporter 2 (SGLT2) inhibitors in the CKD population suggest a slight increase in the total CKD population and a slight reduction in the ESRD population growth rate that remain materially consistent with the patient population forecasts which do not include the utilization of these drugs.
GLP-1 receptor agonist and sodium-glucose cotransporter 2 (SGLT2) inhibitor utilization in the CKD population suggest an increase in the total CKD population and a reduction in the ESRD population growth rate that remain materially consistent with the patient population forecasts which do not include the utilization of these drugs.
Companies’ ESG activities are facing increased scrutiny from stakeholders such as institutional and other investors, regulatory bodies and non-governmental organizations (NGOs).
Companies’ environmental, social, and governance (ESG) activities are facing increased scrutiny from stakeholders such as institutional and other investors, regulatory bodies, and non-governmental organizations (NGOs).
Continuing consolidation in our industry could adversely affect our ability to find suitable acquisition targets and to increase future growth and product sales. 15 Table of Contents We also compete with other health care companies in seeking suitable acquisition targets and developing our core health care businesses.
Continuing consolidation in our industry could adversely affect our ability to find suitable acquisition targets and to increase future growth and product sales. 14 Table of Contents We also compete with other healthcare companies in seeking suitable acquisition targets and developing our core healthcare businesses.
At December 31, 2024, we had consolidated debt (including lease liabilities as well as debt and lease liabilities included within liabilities directly associated with assets held for sale) of €10,988 M and consolidated total shareholders’ equity of €15,769 M.
At December 31, 2025, we had consolidated debt (including lease liabilities as well as debt and lease liabilities included within liabilities directly associated with assets held for sale) of €10,795 M and consolidated total shareholders’ equity of €14,283 M (€10,988 M and €15,769 M, respectively at December 31, 2024).
For further information, see Item 4B, “Information on the Company Business Overview Regulatory and Legal Matters Reimbursement.” In addition to the foregoing factors, the health care insurance industry is experiencing continuing consolidation among insurers and pharmacy benefit managers, including increasing buyer power and impacts on referral streams.
For further information, see Item 4B, “Information on the Company Business Overview Regulatory and Legal Matters Reimbursement.” 8 Table of Contents In addition to the foregoing factors, the healthcare insurance industry is experiencing continuing consolidation among insurers and pharmacy benefit managers, including increasing buyer power and impacts on referral streams.
In the Marietta case, the questions presented involved whether the health plan violated the Medicare Secondary Payor Act (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.
In the Marietta case, the questions presented involved whether the health plan violated the Medicare Secondary Payor Act (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.
While the positive cardiovascular effects of the drugs, reducing mortality, as well as the progression-delaying effect of the drugs on the CKD population indicate a balanced effect of these drugs on our patient population, we cannot ensure that further developments or changes in population will not lead to a material adverse effect on our business and results of operations.
Considering the positive cardiovascular effects of the drugs, reducing mortality, as well as the progression-delaying effect on the CKD population, the Company sees a balanced effect of the drugs on the patient population. However, we cannot ensure that further developments or changes in population will not lead to a material adverse effect on our business and results of operations.
Our €2 billion syndicated multicurrency sustainability-linked revolving credit facility agreement (Syndicated Credit Facility), which serves as a backup facility, includes a sustainability component, pursuant to which the credit facility’s margin for any outstanding borrowings will rise or fall depending on our sustainability performance.
Our €2 BN syndicated multicurrency sustainability-linked revolving credit facility agreement entered in July 2021 (Syndicated Credit Facility), which serves as a backup facility, includes a sustainability component, pursuant to which the credit facility’s margin for any outstanding borrowings will rise or fall depending on our sustainability performance.
The applicable regulations, which differ from country to country, cover areas that include: regulatory approvals for products or product improvements; regulatory approvals and oversight of clinical and certain non-clinical R&D activities; the quality, safety and efficacy of medical and pharmaceutical products and supplies; the operation and licensure of manufacturing facilities, laboratories, dialysis clinics, ambulatory surgery centers and other health care facilities; product labeling, advertising and other promotion; accurate reporting and billing for government and third-party reimbursement, including accurate and complete medical records to support such billing and, in the U.S., the obligation to report and return overpayments within 60 days of the time that the overpayment is identified and quantified; the discounting of reimbursed drug and medical device products and the reporting of drug prices to government authorities; limits on our ability to make acquisitions or certain investments and the terms of those transactions; the collection, dissemination, access, use, security, protection and privacy of protected health information or other protected data, as well as requirements to report data breaches to regulatory agencies; and compensation of medical directors and other financial arrangements with physicians and other referral sources. 9 Table of Contents Failure to comply with one or more of these laws or regulations may give rise to a number of adverse legal consequences.
The applicable regulations, which differ from country to country, cover areas that include: regulatory approvals for products or product improvements; regulatory approvals and oversight of clinical and certain non-clinical R&D activities; the quality, safety and efficacy of medical and pharmaceutical products and supplies; the operation and licensure of manufacturing facilities, laboratories, dialysis clinics, ambulatory surgery centers, and other healthcare facilities; product labeling, advertising, and other promotions; accurate reporting and billing for government and third-party reimbursement, including accurate and complete medical records to support such billing and, in the U.S., the obligation to report and return overpayments within 60 days of the time that the overpayment is identified and quantified; the discounting of reimbursed drug and medical device products and the reporting of drug prices to government authorities; limits on our ability to make acquisitions or certain investments and the terms of those transactions; the collection, dissemination, access, use, security, protection, and privacy of protected health information or other protected data, as well as requirements to report data breaches to regulatory agencies; and compensation of medical directors and other financial arrangements with physicians and other referral sources.
Our operations in both our health care services business and our products business are subject to extensive governmental regulation in virtually every country in which we operate. We are also subject to other laws of general applicability, including antitrust, anti-bribery and anti-corruption laws as well as sustainability requirements.
Our operations are subject to extensive governmental regulation in virtually every country in which we operate. We are also subject to other laws of general applicability, including antitrust, anti-bribery, and anti-corruption laws as well as sustainability requirements.
Although Fresenius SE no longer controls our Company through ownership of 100% of Management AG, its significant share of ownership, certain provisions of our Articles of Association and certain provisions of our trademark license from Fresenius SE enable Fresenius SE to retain significant influence over the management of the Company.
Business overview Corporate strategy and objectives.” Although Fresenius SE no longer controls our Company through ownership of 100% of Management AG, its significant share of ownership, certain provisions of our Articles of Association and certain provisions of our trademark license from Fresenius SE enable Fresenius SE to retain significant influence over the management of the Company.
We may be subject to breaches of the information technology security systems we use both internally and externally with third-party service providers. 10 Table of Contents Cyber-attacks may penetrate our and our third-party service providers’ security controls and result in the misappropriation or compromise of personal information or proprietary or confidential information, including such information which is stored or transmitted on the systems used by certain of our or their products, to create system disruptions, cause shutdowns (including disruptions to our production plants), or deploy viruses, worms, ransomware, denial-of-service attacks and other malicious software programs that attack our systems.
Cyber-attacks may penetrate our and our third-party service providers’ security controls and result in the misappropriation or compromise of personal information or proprietary or confidential information, including such information which is stored or transmitted on the systems used by certain of our or their products, to create system disruptions, cause shutdowns (including disruptions to our production plants), or deploy viruses, worms, ransomware, denial-of-service attacks and other malicious software programs that attack our systems.
The Restore Protections for Dialysis Patients Act 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 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.
Central European Time (CET). Exchange rates December 31, December 31, 2024 2023 2024 2023 2022 spot exchange spot exchange average exchange average exchange average exchange rate in rate in rate in rate in rate in 1 U.S. dollar 0.96256 0.90498 0.92386 0.92484 0.94962 B.
Central European Time (CET). Exchange rates December 31, December 31, 2025 2024 2025 2024 2023 spot exchange spot exchange average exchange average exchange average exchange rate in rate in rate in rate in rate in 1 U.S. dollar 0.85106 0.96256 0.88499 0.92386 0.92484 B.
Any of these events, in combination or alone, could disrupt our business and have a material adverse impact on our business, financial condition and results of operations. We operate many facilities and engage with other business associates to help carry out our health care activities.
Any of these events, in combination or alone, could disrupt our business and have a material adverse impact on our business, financial condition, and results of operations. 9 Table of Contents We operate many facilities and engage with other business associates to help conduct our healthcare activities.
For information about certain of these pending investigations and lawsuits, see note 25 of the notes to our consolidated financial statements included in this report. 12 Table of Contents Risks relating to internal control and compliance We operate in many different jurisdictions and we could be adversely affected by violations of the U.S.
For information about certain of these pending investigations and lawsuits, see note 25 of the notes to our consolidated financial statements included in this report. Risks relating to internal control and compliance We operate in many different jurisdictions and we could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act and similar worldwide anti-corruption laws. The U.S.
For example, the Budget Control Act of 2011 (BCA) required a $1.2 trillion reduction in deficits through 2021. As a backup, if Congress could not agree on proposals to reach this target, sequestration or across-the-board spending cuts would go into effect (U.S. Sequestration). On April 1, 2013, a 2% reduction to Medicare payments took effect and continues in force.
As a backup, if Congress could not agree on proposals to reach this target, sequestration or across-the-board spending cuts would go into effect (U.S. Sequestration). On April 1, 2013, a 2% reduction to Medicare payments took effect and continues in force.
Should further regulation (such as climate disclosure requirements for entities with operations in California, U.S.) or stakeholder expectations be more stringent in the future, we may experience increased compliance burdens and costs to meet regulatory obligations and we cannot currently estimate what impact existing and future regulations will have on our business, financial condition and results of operations.
Should further regulation (such as climate disclosure requirements for entities with operations in California, U.S.) or stakeholder expectations be more stringent in the future, we may experience increased compliance burdens and costs to meet regulatory obligations and we cannot currently estimate what impact existing and future regulations will have on our business, financial condition, and results of operations. 18 Table of Contents We are subject to risks associated with unpredictable events, such as public health crises and epidemics/pandemics or other significant events beyond our control.
For example, legislation seeking to impose additional income taxes against discriminatory or territorial tax of foreign jurisdictions could have negative effects on the amount of income tax expense which are currently unpredictable.
Additionally, tax legislation in countries in which we operate is subject to constant change and development. For example, legislation seeking to impose additional income taxes against discriminatory or territorial tax of foreign jurisdictions could have negative effects on the amount of income tax expense which are currently unpredictable.
The COVID-19 global pandemic resulted in higher costs incurred to address staffing shortages, implement preventive measures to protect patients, employees and others, as well as a material deterioration of supply chains and the conditions of the global economy and financial markets.
The COVID-19 global pandemic resulted in higher costs incurred to address staffing shortages, implement preventive measures to protect patients, employees, and others, as well as a material deterioration of supply chains and the conditions of the global economy and financial markets. Any such unforeseeable events could have a material adverse effect on our business, financial condition, and results of operations.
While we have been able to obtain liability insurance in the past to partially cover our business risks, we cannot assure that such insurance will be available in the future either on acceptable terms or at all, or that our insurance carriers will not dispute their coverage obligations.
These costs could have a material adverse impact on our business, financial condition, and results of operations. 11 Table of Contents While we have been able to obtain liability insurance in the past to partially cover our business risks, we cannot assure that such insurance will be available in the future either on acceptable terms or at all, or that our insurance carriers will not dispute their coverage obligations.
See note 25 of the notes to the consolidated financial statements included in this report. 16 Table of Contents Our competitors could develop superior technology or otherwise take advantage of new competitive developments that impact our sales.
See note 25 of the notes to the consolidated financial statements included in this report. 15 Table of Contents Our competitors could develop superior technology or otherwise take advantage of new competitive developments that impact our sales. We face numerous competitors, some of whom may possess substantial financial, marketing, or R&D resources.
An increased utilization of bundled pharmaceuticals, as part of the ESRD PPS, or decreases in reimbursement for pharmaceuticals outside the bundled rate may result in a material adverse impact on our results of operations.
An increased utilization of bundled pharmaceuticals as part of the ESRD PPS, the termination or expiration of certain payments made during a limited transitional period following incorporation of a pharmaceutical into the ESRD PPS, or decreases in reimbursement for pharmaceuticals outside the bundled rate may result in a material adverse impact on our results of operations.
Should management fail to meet these outcomes, investors and/or debt providers may not deem us the correct fit for their investment or financing purposes, thereby negatively impacting our share price or our ability to source funding through debt financing.
Considering these expectations, among other aspects, we have incorporated sustainability as a performance target for the compensation of our Management Board. Should management fail to meet these outcomes, investors and/or debt providers may not deem us the correct fit for their investment or financing purposes, thereby negatively impacting our share price or our ability to source funding through debt financing.
Additionally, such failure could expose us to mandatory public disclosure requirements, litigation and governmental enforcement proceedings, material fines, penalties and/or remediation costs, and compensatory, special, punitive and statutory damages, consent orders and other adverse actions, any of which could have a material adverse impact on our business, financial condition and results of operations. 11 Table of Contents If certain of our investments or value and risk-based care programs with health care organizations and health care providers are found to have violated the law, our business could be adversely affected.
Additionally, such failure could expose us to mandatory public disclosure requirements, litigation and governmental enforcement proceedings, material fines, penalties and/or remediation costs, and compensatory, special, punitive and statutory damages, consent orders and other adverse actions, any of which could have a material adverse impact on our business, financial condition, and results of operations.
We are subject to potential changes in tax legislation as well as to ongoing tax audits in Germany, the U.S. and other jurisdictions. We have received notices of unfavorable adjustments and disallowances in connection with certain of these audits. Additionally, tax legislation in countries in which we operate is subject to constant change and development.
Diverging views of fiscal authorities or changes in tax legislation could require us to make additional tax payments. We are subject to potential changes in tax legislation as well as to ongoing tax audits in Germany, the U.S., and other jurisdictions. We have received notices of unfavorable adjustments and disallowances in connection with certain of these audits.
As a result of its share ownership, its de facto veto right over shareholder votes requiring a qualified majority and its representation on our Supervisory Board (including the Chair), Fresenius SE will continue to have the ability to exercise significant influence over the management of our Company in its form as an AG, and the interests and rights of Fresenius SE could deviate from the interests of the Company and its public shareholders. 22 Table of Contents We use “Fresenius” in our name and trademarks under a royalty-free license from Fresenius SE.
As a result of its share ownership, its de facto veto right over shareholders’ votes requiring a qualified majority and its representation on the Supervisory Board (including the chair), Fresenius SE will continue to have the ability to exercise significant influence over the management of the Issuer in its form as a German Stock Corporation ( Aktiengesellschaft ), and the interests and rights of Fresenius SE could deviate from those of the Issuer.
We receive reimbursement for our health care services from both public, government-sponsored payors and private, commercial payors. A large portion of our businesses is reimbursed by government payors, in particular the Medicare and Medicaid programs in the U.S.
A large portion of our businesses is reimbursed by government payors, in particular the Medicare and Medicaid programs in the U.S.
Our health care products business depends on the development of new products, technologies and treatment concepts to be competitive, and for that we need to attract the best and most talented people, especially in R&D.
Our continued growth will depend upon our ability to attract and retain a skilled workforce, including highly skilled nurses, technicians, and other medical personnel. Our healthcare products business depends on the development of new products, technologies, and treatment concepts to be competitive, and for that we need to attract the best and most talented people, especially in R&D.
Our IT systems have been attacked in the past, resulting in certain patient data being illegally published. For information regarding our cybersecurity risk management and governance, see Item 16K. “Cybersecurity.” For information regarding litigation relating to cybersecurity incidents we experienced in 2023, see note 25 of the notes to the consolidated financial statements included in this report.
Our IT systems have been attacked in the past, resulting in certain patient data being illegally published. For information regarding our cybersecurity risk management and governance, see Item 16K.
The present Fresenius SE designees on our Supervisory Board are the Chief Executive Officer and Chief Financial Officer, respectively, of Fresenius SE.
The present Fresenius SE designees on our Supervisory Board are the Chief Executive Officer and Chief Financial Officer, respectively, of Fresenius SE. We use “Fresenius” in our name and trademarks under a royalty-free license from Fresenius SE.
For further information regarding Medicare and Medicaid reimbursement, including new payment models proposed by executive order in July 2019 which are intended to encourage identification and earlier treatment of kidney disease as well as increased home dialysis and transplants, see Item 4B, “Information on the Company Business Overview Regulatory and Legal Matters Reimbursement.” Our patients make decisions about their insurance coverage among options that, depending on their personal circumstances and location, may include Medicare, Medicaid, Medicare Advantage plans, employer group health coverage, exchange plans and other commercial coverage.
For further information regarding OBBBA, see Item 4B, “Information on the Company Business Overview Regulatory and Legal Matters Healthcare reform.” Our patients make decisions about their insurance coverage among options that, depending on their personal circumstances and location, may include Medicare, Medicaid, Medicare Advantage plans, employer group health coverage, exchange plans, and other commercial coverage.
We could be subject to fines and other financial burdens associated with global environmental, social and governance regulations, laws and activities, and we could alienate our patients, employees, customers, partners, investors and the communities we serve. Furthermore, if we do not meet investors’ or certain markets’ ESG standards, the market for our securities could be adversely impacted.
If we are unable to meet applicable legal requirements and/or market expectations with respect to sustainability, both our business and our reputation could suffer. We could be subject to fines and other financial burdens associated with global environmental, social and governance regulations, laws and activities, and we could alienate our patients, employees, customers, partners, investors, and the communities we serve.
Similarly, price increases by suppliers (including from the impact of inflation) and the inability to access new products or technology could also adversely affect our results of operations. In particular, the lingering macroeconomic inflationary environment, together with geopolitical conflicts, have resulted in and could continue to lead to, among other consequences, material increases in costs for energy, supplies and transportation.
In particular, the lingering macroeconomic inflationary environment, together with geopolitical conflicts, have resulted in and could continue to lead to, among other consequences, material increases in costs for energy, supplies and transportation.
If our estimates of revenues are materially inaccurate, it could impact the timing and amount of our recognition of revenues and have a significant impact on our operating results and financial condition.
If our estimates of revenues are materially inaccurate, it could impact the timing and amount of our recognition of revenues and have a significant impact on our operating results and financial condition. For further information regarding our revenue recognition policies, see note 1 k) of the notes to the consolidated financial statements included in this report.
Our ability to make payments on and to refinance our indebtedness will depend on our ability to generate cash in the future, which is dependent on various factors. These factors include governmental and private insurer reimbursement rates for medical treatment and general economic, financial, competitive, legislative, regulatory, and other factors that are beyond our control.
These factors include governmental and private insurer reimbursement rates for medical treatment and general economic, financial, competitive, legislative, regulatory, and other factors that are beyond our control.
FME AG is not subject to any covenant that limits its ability to incur unsecured debt, regardless of our credit rating. If additional debt is added to our current debt levels, the related risks that we now face from our indebtedness could intensify.
FME AG is not subject to any covenant that limits its ability to incur unsecured debt, regardless of our credit rating.

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Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeWe produce and assemble hemodialysis machines and peritoneal dialysis cyclers in Germany and in Mexico. We manufacture and assemble dialyzers and polysulfone membranes in the U.S., Germany, France and Japan. We also produce and assemble hemodialysis machines and dialyzers in China. We manufacture hemodialysis concentrate products and PD solutions at various facilities worldwide.
Biggest changeThe 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.
Value and risk-based care programs We conduct a broad range of value and risk-based care programs spanning CKD and ESRD patient populations with both private and public payors.
We conduct a broad range of value and risk-based care programs spanning CKD and ESRD patient populations with both private and public payors.
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.
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.
ACA provides for broad health care 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 health care 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 health care program waste and fraud and (viii) a 2.3% excise tax on manufacturers’ medical device sales starting in 2013.
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.
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 health care funding systems are mostly seen in New Zealand, Malaysia and Thailand where governments have more direct levers to manage the provision of health care.
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.
Upon receipt of an EC 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.
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.
Failure to comply with a safe harbor does not render an arrangement illegal under the federal Anti-Kickback Statute and, therefore, physician 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.
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.
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 Care Enablement With a focus on quality, costs and availability, we introduced an improved organizational infrastructure with efficient processes and systems over the last several years.
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.
Plants producing products with the Conformité Européene (CE) 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.
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.
Moreover, 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.
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.
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, followed by further discussion and review in risk committees.
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.
A quarterly certification process has been implemented as a formal accountability and responsibility mechanism for countries, segments, shared services centers as well as corporate entities which aims at the accuracy of financial reporting and the associated disclosure controls and procedures.
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.
Trademarks As the owner of trademarks or licensee under 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.
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.
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), which aim to build on the existing Comprehensive ESRD Care model.
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.
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 health care centers, laboratories and manufacturing facilities for health care products, the provision of high quality health care 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.
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 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 health care 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.
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.
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. 79 Table of Contents D. Property, plant and equipment Property The table below describes our principal facilities.
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.
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 health care system financed by taxes. However, during the last decade, health care financing under many social security systems has also been significantly subsidized with tax money.
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.
The Pradhan Mantri National Dialysis Programme launched the Ayushman Bharat Yojana, a national health insurance scheme aimed at providing free access to health care 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 health care.
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.
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 health care coverage and reimbursement, there is a clear trend for volume-based procurement of medical technologies.
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.
The ACA, enacted in 2010, contained broad health care 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 health care 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 health care program waste and fraud and (viii) a 2.3% excise tax on manufacturers’ medical device sales starting in 2013.
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.
With close to €8.0 billion 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.
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.
Subsequently, the central 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.
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.
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 health care centers, renal diagnostic support business and laboratories must be certified by CMS.
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.
Other countries, such as Japan and South Korea, finance health care 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.
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.
These voluntary models create financial incentives for health care 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 health care providers to take on various amounts of financial risk by forming an entity known as a KCE.
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.
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 health care fraud and abuse laws and similar state laws. The 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.
If our employees or their agents or subcontractors, deliberately or inadvertently, were to submit inadequate or incorrect billings to any federally-funded health care 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.
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.
We allocated 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.
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.
Supreme Court reversed the Sixth Circuit decision and held that the employee health plan 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.
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.
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. 24 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, 2024 and our reports for prior years, filed with the SEC and also available on our website www.freseniusmedicalcare.com.
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.
We believe we are also viewed as a valuable strategic health care partner outside the dialysis business due to our experience in managing chronic disease for dialysis patients and our record of improving quality and patient satisfaction and reducing the overall cost of care, and our leadership in advancing innovation and improvement in health care.
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.
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, as well as 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.
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.
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 health care 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.
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.
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. 41 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.
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.
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-competition clauses concerning certain activities in defined areas for a defined period of time.
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.
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.
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.
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 health care service operations.
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.
Patient, physician and other relationships We believe that our success in establishing and maintaining health care 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.
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.
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.” Item 4A. Unresolved staff comments Not applicable 80 Table of Contents
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.” Item 4A. Unresolved staff comments Not applicable 67 Table of Contents
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 health care expenditure in the country.
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.
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. 64 Table of Contents 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.
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.
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; recoupment or required refunding of payments received from government and private payors as well as government health care program beneficiaries because of any failures to meet applicable requirements; a non-appealable finding of material violations of applicable health care or other laws; and changes resulting from health care reform or other government actions that restrict our operations, reduce reimbursement or reduce or eliminate coverage for particular products or services we provide.
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.
Grace & Co., whose sole business at the time of the transaction consisted of National Medical Care, Inc., its global health care 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., 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.
Information regarding authorizations granted by our Annual General Meeting (AGM) to conduct share buy-back 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.
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.
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.
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.
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 health care provider (public or private).
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).
In the Latin America region, health care 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.
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.
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 health care providers and potential referral sources and reimbursement for services and items provided to patients with Medicare, Medicaid and other types of U.S.
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.
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 health care 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.
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.
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 health care coverage, there is no other constitutional provision that justifies this exercise of congressional power.
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.
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 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.
MACRA creates an elaborate scheme of incentive payments and penalty adjustments starting 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.
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.
In the U.S., some states establish regulatory processes that must be satisfied prior to the establishment of new health care centers. Outside the U.S., each country has its own payment and reimbursement rules and procedures, and some countries prohibit private ownership of health care providers or establish other regulatory barriers to direct ownership by foreign companies.
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.
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 ending in June 2027.
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.
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. Other parts of the patent portfolio relate to platform and future technologies, such as digital and data management.
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.
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 health care 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.
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.
ACA includes a provision referred to as the individual mandate that 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.
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.
Global Medical Office Our GMO plays a pivotal role in contributing clinical expertise to the management of our business, 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.
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.
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 health care in Eastern Europe and Asia could present additional acquisition opportunities.
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, and the health care 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 health care laws that may create further restrictions.
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.
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, 2024, 2023 and 2022, see notes 5 a) and 29 of the notes to the consolidated financial statements included in this report. 26 Table of Contents We receive a substantial portion of our Care Delivery revenue from the U.S.
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.
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 note 1 a) of the notes to our audited consolidated financial statements included in this report.
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.
Civil Monetary Penalties Law, including the prohibition on inducements to patients to select a particular health care 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, we are subject to laws and regulations including privacy and data protection.
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.
Two options, the CKCC global and professional models, allow renal health care 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.
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.
(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.
(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.
The analysis of the risk environment 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 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.
Therefore, our Management Board is informed on a monthly basis 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. The Global Internal Audit department is regularly informed about the results of the risk management system.
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.
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. Potential changes impacting our private payors in the U.S.
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 product is currently supplied to over 5,000 dialysis clinics in the U.S. and its territories. 34 Table of Contents Retacrit ® (epoetin alfa-epbx) is a short-acting ESA approved in the US in 2018 for all indications of its reference drug, epoetin alfa.
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.
See Regulatory and legal matters Reimbursement Possible changes in statutes or regulations,” below. 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.
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.
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 renal failure, the predominant treatment method is continuous renal replacement therapy. Over 50%, or slightly more than 1 M acute patients, were treated with this method in 2024 (2023: over 50% or around 1 M).
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).
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 2024 sales to Iran represent approximately 0.05% of our total revenues.
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.
PMG will focus 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.
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.
In Germany, the German Drug Law ( Arzneimittelgesetz or AMG), which implements several EU requirements, is the primary regulation applicable to medicinal products. The provisions of the AMG are comparable with the legal standards in all other European Union countries.
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.
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. Non-U.S.
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.
Several states have certificate of need programs regulating the establishment or expansion of health care facilities, including dialysis centers. We believe that we have obtained all necessary approvals for the operation of our health care facilities in accordance with all applicable state certificate of need laws.
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.
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 health care coverage. The provision became effective in 2019.
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 U.S. Sequestration is independent of Medicare’s annual inflation update mechanisms, such as the market basket update pursuant to the ESRD PPS. 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 been paid separately.
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.
A number of the dialysis clinics and other health care 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.
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.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

138 edited+140 added53 removed60 unchanged
Biggest changeThe following tables show the reconciliation of average invested capital to total assets, which we believe to be the most directly comparable IFRS Accounting Standards financial measure, and how ROIC is calculated: Reconciliation of average invested capital and ROIC (Non-IFRS Measure, unadjusted) in M, except where otherwise specified December 31, September 30, June 30, March 31, December 31, 2024 2024 2024 2024 2024 2023 Total assets 33,567 32,511 33,896 34,336 33,930 Plus: Cumulative goodwill amortization and impairment loss (1) 504 519 565 519 629 Minus: Cash and cash equivalents (1) (1,185) (1,387) (1,112) (1,192) (1,427) Minus: Deferred tax assets (1) (230) (296) (281) (279) (292) Minus: Accounts payable to unrelated parties (1) (906) (779) (793) (748) (775) Minus: Accounts payable to related parties (55) (73) (100) (110) (123) Minus: Provisions and other current liabilities (2) (2,803) (2,671) (3,062) (3,026) (2,936) Minus: Income tax liabilities (1) (222) (227) (189) (280) (231) Invested capital 28,670 27,597 28,924 29,220 28,775 Average invested capital as of December 31, 2024 28,637 Operating income 1,392 Income tax expense (3) (502) NOPAT 890 Adjustments to average invested capital and ROIC in M, except where otherwise specified December 31, September 30, June 30, March 31, December 31, 2024 2024 2024 (4) 2024 (4) 2024 (4) 2023 (4) Total assets (38) (47) (622) (709) Plus: Cumulative goodwill amortization and impairment loss (2) (2) (50) (84) Minus: Cash and cash equivalents 3 5 24 35 Minus: Deferred tax assets 2 2 3 10 Minus: Accounts payable to unrelated parties 2 2 13 12 Minus: Accounts payable to related parties 1 1 Minus: Provisions and other current liabilities (2) 8 7 29 39 Minus: Income tax liabilities 1 3 Invested capital (25) (33) (601) (693) Adjustment to average invested capital as of December 31, 2024 (270) Adjustment to operating income (4) 139 Adjustment to income tax expense (4) (50) Adjustment to NOPAT 89 83 Table of Contents Reconciliation of average invested capital and ROIC (Non-IFRS Measure) in M, except where otherwise specified December 31, September 30, June 30, March 31, December 31, 2024 2024 2024 (4) 2024 (4) 2024 (4) 2023 (4) Total assets 33,567 32,473 33,849 33,714 33,221 Plus: Cumulative goodwill amortization and impairment loss (1) 504 517 563 469 545 Minus: Cash and cash equivalents (1) (1,185) (1,384) (1,107) (1,168) (1,392) Minus: Deferred tax assets (1) (230) (294) (279) (276) (282) Minus: Accounts payable to unrelated parties (1) (906) (777) (791) (735) (763) Minus: Accounts payable to related parties (55) (73) (100) (109) (122) Minus: Provisions and other current liabilities (2) (2,803) (2,663) (3,055) (2,997) (2,897) Minus: Income tax liabilities (1) (222) (227) (189) (279) (228) Invested capital 28,670 27,572 28,891 28,619 28,082 Average invested capital as of December 31, 2024 28,367 Operating income (4) 1,531 Income tax expense (3), (4) (552) NOPAT 979 ROIC in % 3.5 Adjustments to average invested capital and ROIC (excluding Legacy Portfolio Optimization costs) in M, except where otherwise specified December 31, 2024 2024 Adjustment to operating income 136 Adjustment to income tax expense 80 Adjustment to NOPAT 216 84 Table of Contents Reconciliation of average invested capital and ROIC (Non-IFRS Measure, excluding Legacy Portfolio Optimization costs) in M, except where otherwise specified December 31, September 30, June 30, March 31, December 31, 2024 2024 2024 (4) 2024 (4) 2024 (4) 2023 (4) Total assets 33,567 32,473 33,849 33,714 33,221 Plus: Cumulative goodwill amortization and impairment loss (1) 504 517 563 469 545 Minus: Cash and cash equivalents (1) (1,185) (1,384) (1,107) (1,168) (1,392) Minus: Deferred tax assets (1) (230) (294) (279) (276) (282) Minus: Accounts payable to unrelated parties (1) (906) (777) (791) (735) (763) Minus: Accounts payable to related parties (55) (73) (100) (109) (122) Minus: Provisions and other current liabilities (2) (2,803) (2,663) (3,055) (2,997) (2,897) Minus: Income tax liabilities (1) (222) (227) (189) (279) (228) Invested capital 28,670 27,572 28,891 28,619 28,082 Average invested capital as of December 31, 2024 28,367 Operating income (4) 1,667 Income tax expense (3), (4) (472) NOPAT 1,195 ROIC in % (excluding Legacy Portfolio Optimization costs) 4.2 Reconciliation of average invested capital and ROIC (Non-IFRS Measure, unadjusted) in M, except where otherwise specified December 31, September 30, June 30, March 31, December 31, 2023 2023 2023 2023 2023 2022 Total assets 33,930 35,635 34,960 35,501 35,754 Plus: Cumulative goodwill amortization and impairment loss 629 703 644 640 645 Minus: Cash and cash equivalents (1) (1,427) (1,574) (1,363) (1,224) (1,274) Minus: Loans to related parties (1) Minus: Deferred tax assets (1) (292) (304) (314) (307) (313) Minus: Accounts payable to unrelated parties (1) (775) (762) (721) (822) (813) Minus: Accounts payable to related parties (123) (119) (140) (111) (138) Minus: Provisions and other current liabilities (2) (2,936) (3,235) (3,018) (3,007) (3,008) Minus: Income tax liabilities (231) (263) (230) (215) (171) Invested capital 28,775 30,081 29,818 30,455 30,681 Average invested capital as of December 31, 2023 29,962 Operating income 1,369 Income tax expense (3) (508) NOPAT 861 85 Table of Contents Adjustments to average invested capital and ROIC in M, except where otherwise specified December 31, September 30, June 30, March 31, December 31, 2023 2023 2023 (4) 2023 (4) 2023 (4) 2022 (4) Total assets (370) (361) (361) (368) Minus: Cash and cash equivalents 20 20 20 20 Minus: Accounts payable to unrelated parties 5 5 5 5 Minus: Provisions and other current liabilities (2) 16 16 16 16 Invested capital (329) (320) (320) (327) Adjustment to average invested capital as of December 31, 2023 (259) Adjustment to operating income (4) (32) Adjustment to income tax expense (4) 12 Adjustment to NOPAT (20) Reconciliation of average invested capital and ROIC (Non-IFRS Measure) in M, except where otherwise specified December 31, September 30, June 30, March 31, December 31, 2023 2023 2023 (4) 2023 (4) 2023 (4) 2022 (4) Total assets 33,930 35,265 34,599 35,140 35,386 Plus: Cumulative goodwill amortization and impairment loss 629 703 644 640 645 Minus: Cash and cash equivalents (1) (1,427) (1,554) (1,343) (1,204) (1,254) Minus: Loans to related parties (1) Minus: Deferred tax assets (1) (292) (304) (314) (307) (313) Minus: Accounts payable to unrelated parties (1) (775) (757) (716) (817) (808) Minus: Accounts payable to related parties (123) (119) (140) (111) (138) Minus: Provisions and other current liabilities (2) (2,936) (3,219) (3,002) (2,991) (2,992) Minus: Income tax liabilities (231) (263) (230) (215) (171) Invested capital 28,775 29,752 29,498 30,135 30,354 Average invested capital as of December 31, 2023 29,703 Operating income (4) 1,337 Income tax expense (3), (4) (496) NOPAT 841 ROIC in % 2.8 (1) Includes amounts related to assets, and associated liabilities, classified as held for sale (see note 4 of the notes to the consolidated financial statements included in this report).
Biggest changeThe following tables show the reconciliation of average invested capital to total assets, which we believe to be the most directly comparable IFRS Accounting Standards financial measure, and how ROIC is calculated: 69 Table of Contents Reconciliation of average invested capital and ROIC (Non-IFRS Measure, unadjusted) in M, except where otherwise specified December 31, September 30, June 30, March 31, December 31, 2025 2025 2025 2025 2025 2024 Total assets 31,002 30,887 31,291 32,735 33,567 Plus: Cumulative goodwill amortization and impairment loss 379 380 465 494 504 Minus: Cash and cash equivalents (1) (1,599) (1,256) (1,720) (1,079) (1,185) Minus: Deferred tax assets (1) (237) (231) (232) (225) (230) Minus: Accounts payable to unrelated parties (1) (738) (726) (687) (771) (906) Minus: Accounts payable to related parties (85) (92) (48) (106) (55) Minus: Provisions and other current liabilities (2) (2,699) (3,235) (2,496) (2,637) (2,803) Minus: Income tax liabilities (1) (248) (256) (247) (238) (222) Invested capital 25,775 25,471 26,326 28,173 28,670 Average invested capital as of December 31, 2025 26,883 Operating income 1,827 Income tax expense (3) (451) NOPAT 1,376 Adjustments to average invested capital and ROIC in M, except where otherwise specified December 31, September 30, June 30, March 31, December 31, 2025 2025 2025 (4) 2025 (4) 2025 (4) 2024 (4) Total assets (56) (58) (57) Plus: Cumulative goodwill amortization and impairment loss (76) (78) (76) Minus: Cash and cash equivalents 4 5 4 Minus: Deferred tax assets Minus: Accounts payable to unrelated parties 1 1 2 Minus: Accounts payable to related parties Minus: Provisions and other current liabilities (2) 12 13 12 Minus: Income tax liabilities 2 2 2 Invested capital (113) (115) (113) Adjustment to average invested capital as of December 31, 2025 (68) Adjustment to operating income (4) (35) Adjustment to income tax expense (4) 9 Adjustment to NOPAT (26) 70 Table of Contents Reconciliation of average invested capital and ROIC (Non-IFRS Measure) in M, except where otherwise specified December 31, September 30, June 30, March 31, December 31, 2025 2025 2025 (4) 2025 (4) 2025 (4) 2024 (4) Total assets 31,002 30,887 31,235 32,677 33,510 Plus: Cumulative goodwill amortization and impairment loss 379 380 389 416 428 Minus: Cash and cash equivalents (1) (1,599) (1,256) (1,716) (1,074) (1,181) Minus: Deferred tax assets (1) (237) (231) (232) (225) (230) Minus: Accounts payable to unrelated parties (1) (738) (726) (686) (770) (904) Minus: Accounts payable to related parties (85) (92) (48) (106) (55) Minus: Provisions and other current liabilities (2) (2,699) (3,235) (2,484) (2,624) (2,791) Minus: Income tax liabilities (1) (248) (256) (245) (236) (220) Invested capital 25,775 25,471 26,213 28,058 28,557 Average invested capital as of December 31, 2025 26,815 Operating income (4) 1,792 Income tax expense (3), (4) (442) NOPAT 1,350 ROIC in % 5.0 Reconciliation of average invested capital and ROIC (Non-IFRS Measure, unadjusted) in M, except where otherwise specified December 31, September 30, June 30, March 31, December 31, 2024 2024 2024 2024 2024 2023 Total assets 33,567 32,511 33,896 34,336 33,930 Plus: Cumulative goodwill amortization and impairment loss 504 519 565 519 629 Minus: Cash and cash equivalents (1) (1,185) (1,387) (1,112) (1,192) (1,427) Minus: Deferred tax assets (1) (230) (296) (281) (279) (292) Minus: Accounts payable to unrelated parties (1) (906) (779) (793) (748) (775) Minus: Accounts payable to related parties (55) (73) (100) (110) (123) Minus: Provisions and other current liabilities (2) (2,803) (2,671) (3,062) (3,026) (2,936) Minus: Income tax liabilities (1) (222) (227) (189) (280) (231) Invested capital 28,670 27,597 28,924 29,220 28,775 Average invested capital as of December 31, 2024 28,637 Operating income 1,392 Income tax expense (3) (502) NOPAT 890 71 Table of Contents Adjustments to average invested capital and ROIC in M, except where otherwise specified December 31, September 30, June 30, March 31, December 31, 2024 2024 2024 (4) 2024 (4) 2024 (4) 2023 (4) Total assets (38) (47) (622) (709) Plus: Cumulative goodwill amortization and impairment loss (2) (2) (50) (84) Minus: Cash and cash equivalents 3 5 24 35 Minus: Deferred tax assets 2 2 3 10 Minus: Accounts payable to unrelated parties 2 2 13 12 Minus: Accounts payable to related parties 1 1 Minus: Provisions and other current liabilities (2) 8 7 29 39 Minus: Income tax liabilities 1 3 Invested capital (25) (33) (601) (693) Adjustment to average invested capital as of December 31, 2024 (270) Adjustment to operating income (4) 139 Adjustment to income tax expense (4) (50) Adjustment to NOPAT 89 Reconciliation of average invested capital and ROIC (Non-IFRS Measure) in M, except where otherwise specified December 31, September 30, June 30, March 31, December 31, 2024 2024 2024 (4) 2024 (4) 2024 (4) 2023 (4) Total assets 33,567 32,473 33,849 33,714 33,221 Plus: Cumulative goodwill amortization and impairment loss 504 517 563 469 545 Minus: Cash and cash equivalents (1) (1,185) (1,384) (1,107) (1,168) (1,392) Minus: Deferred tax assets (1) (230) (294) (279) (276) (282) Minus: Accounts payable to unrelated parties (1) (906) (777) (791) (735) (763) Minus: Accounts payable to related parties (55) (73) (100) (109) (122) Minus: Provisions and other current liabilities (2) (2,803) (2,663) (3,055) (2,997) (2,897) Minus: Income tax liabilities (1) (222) (227) (189) (279) (228) Invested capital 28,670 27,572 28,891 28,619 28,082 Average invested capital as of December 31, 2024 28,367 Operating income (4) 1,531 Income tax expense (3), (4) (552) NOPAT 979 ROIC in % 3.5 (1) Includes amounts related to assets, and associated liabilities, classified as held for sale (see note 4 of the notes to the consolidated financial statements included in this report).
Some of the statements contained below, including those concerning future revenue, costs and capital expenditures and possible changes in our industry and competition and financial condition include forward-looking statements.
Some of the statements contained below, including those concerning future revenue, costs, and capital expenditures, and possible changes in our industry, competition, and financial condition include forward-looking statements.
Revenue and revenue growth are also benchmarked based on movement at Constant Exchange Rates (Non-IFRS Measures). Operating income Operating income is the most appropriate measure for evaluating the profitability of the operating segments and therefore is also a key performance indicator.
Revenue and revenue growth are also benchmarked based on movement at Constant Exchange Rates (Non-IFRS Measures). Operating income Operating income is the most appropriate measure for evaluating the profitability of the operating segments and therefore is also a key performance indicator. Operating income is also benchmarked based on movement at Constant Exchange Rates (Non-IFRS Measure).
To determine the net leverage ratio, debt and lease liabilities less cash and cash equivalents (net debt) is compared to adjusted EBITDA, which we define as EBITDA adjusted for: the effects of acquisitions and divestitures made during the year with a purchase price above a €50 M threshold as defined in our Syndicated Credit Facility (See note 17 of the notes to the consolidated financial statements included in this report), non-cash charges, 87 Table of Contents impairment loss (including any impairment losses associated with the FME25 Program and Legacy Portfolio Optimization, as defined below), and special items, including: i. costs related to our FME25 Program, ii. the impact from the remeasurement of our investment in Humacyte, Inc. and receivables related to a royalty stream that we are entitled to base on sales made by Humacyte, Inc. in the U.S.
To determine the net leverage ratio, debt and lease liabilities less cash and cash equivalents (net debt) is compared to adjusted EBITDA, which we define as EBITDA adjusted for: the effects of acquisitions and divestitures made during the year with a purchase price above a €50 M threshold as defined in our Syndicated Credit Facility (See note 17 of the notes to the consolidated financial statements included in this report), non-cash charges, 73 Table of Contents impairment loss (including any impairment losses associated with the FME25+ Program and Legacy Portfolio Optimization, as defined below), and special items, including: i. costs related to our FME25+ Program, ii. the impact from the remeasurement of our investment in Humacyte, Inc. and receivables related to a royalty stream that we are entitled to base on sales made by Humacyte, Inc. in the U.S.
Additionally, we plan accelerated capital expenditures in new production facilities as well as into R&D activities for a more globalized product portfolio. Further information regarding our acquisitions, investments and divestitures, see notes 4 and 5 e) of the notes to the consolidated financial statements included in this report.
Additionally, we plan accelerated capital expenditures in new production facilities as well as into R&D activities for a more globalized product portfolio. Further information regarding our acquisitions, investments and divestitures, see notes 3, 4, and 5 e) of the notes to the consolidated financial statements included in this report.
Basic earnings per share growth Percentage growth in basic earnings per share at Constant Currency (Non-IFRS Measure) is a performance indicator to evaluate our profitability. This indicator helps to manage our overall performance. Basic earnings per share is calculated by dividing net income attributable to shareholders by the weighted-average number of outstanding shares over the course of the year.
Basic earnings per share growth Percentage growth in basic earnings per share at Constant Currency (Non-IFRS Measure) is a performance indicator used to evaluate our profitability. This indicator helps to manage our overall performance. Basic earnings per share is calculated by dividing net income attributable to shareholders by the weighted-average number of outstanding shares over the course of the year.
We believe this information, along with comparable IFRS ® Accounting Standards financial measurements, is useful to our investors as it provides a basis for assessing our performance, payment obligations related to performance-based compensation, our compliance with covenants and enhanced transparency as well as comparability of our results.
We believe this information, along with comparable IFRS Accounting Standards financial measurements, is useful to our investors as it provides a basis for assessing our performance, payment obligations related to performance-based compensation, our compliance with covenants, and enhanced transparency and comparability of our results.
The classification of potential impact and likelihood as well as the localization of the risks within the risk matrix are depicted below: 102 Table of Contents Potential impact Description of impact Classification Likelihood Severe Material negative impact Almost certain > 90% to 100 % Major Significant negative impact Likely > 50% to 90 % Medium Moderate negative impact Possible > 10% to 50 % Low Small negative impact Unlikely 0% to 10 % Likelihood Almost Certain Likely 9, 10, 16 Possible 1, 2, 5, 6, 7, 8, 21 3, 4, 14, 15, 18, 19, 20 12, 17 Unlikely 13 11 Low Medium Major Severe High Risk Medium Risk Low Risk 103 Table of Contents Risk Number Risk factor (or other related disclosure) within the report 1 If we do not comply with the numerous governmental regulations applicable to our business, we could suffer adverse legal consequences, including exclusion from government health care programs or termination of our authority to conduct business, any of which would result in a material decrease in our revenue; this regulatory environment also exposes us to claims and litigation, including “whistleblower” suits. 2 If certain of our investments or value and risk-based care programs with health care organizations and health care providers are found to have violated the law, our business could be adversely affected. 3 If we fail to estimate, price for and manage medical costs in an effective manner, the profitability of our value and risk-based care programs could decline and could materially and adversely affect our results of operations, financial position and cash flows. 4 There are significant risks associated with estimating the amount of health care service revenues that we recognize that could impact the timing of our recognition of revenues or have a significant impact on our operating results and financial condition. 5 Any material disruption in government operations and funding could have a material adverse impact on our business, financial condition and results of operations. 6 A dependency on the payment behavior and decision-making of our business partners can affect the collectability of accounts receivable. 7 Changes in reimbursement, payor mix and/or governmental regulations for health care could materially decrease our revenues and operating profit. 8 We operate in a highly regulated industry such that the potential for legislative reform provides uncertainty and potential threats to our operating models and results. 9 We could be adversely affected if we experience shortages of goods or material price increases from our suppliers, or an inability to access new and improved products and technology. 10 If we are unable to attract and retain skilled medical, technical, engineering or key strategic personnel, or if legislative, union, other labor-related activities or changes or employee absenteeism and turnover result in significant increases in our operating costs or decreases in productivity, we may be unable to manage our growth, continue our technological development or execute our strategy. 11 We operate in many different jurisdictions and we could be adversely affected by violations of the U.S.
The classification of potential impact and likelihood as well as the localization of the risks within the risk matrix are depicted below: Potential impact Description of impact Classification Likelihood Severe Material negative impact Almost certain > 90% to 100 % Major Significant negative impact Likely > 50% to 90 % Medium Moderate negative impact Possible > 10% to 50 % Low Small negative impact Unlikely 0% to 10 % Likelihood Almost Certain Likely 9, 10, 16 Possible 1, 2, 7, 8, 13 3, 4, 5, 6, 12, 14, 15, 18, 20 17, 19 Unlikely 11 Low Medium Major Severe High Risk Medium Risk Low Risk 95 Table of Contents Risk Number Risk factor (or other related disclosure) within the report 1 If we do not comply with the numerous governmental regulations applicable to our business, we could suffer adverse legal consequences, including exclusion from government healthcare programs or termination of our authority to conduct business, any of which would result in a material decrease in our revenue; this regulatory environment also exposes us to claims and litigation, including “whistleblower” suits. 2 If certain of our investments or value and risk-based care programs with healthcare organizations and healthcare providers are found to have violated the law, our business could be adversely affected. 3 If we fail to estimate, price for and manage medical costs in an effective manner, the profitability of our value and risk-based care programs could decline and could materially and adversely affect our results of operations, financial position and cash flows. 4 There are significant risks associated with estimating the amount of healthcare service revenues that we recognize that could impact the timing of our recognition of revenues or have a significant impact on our operating results and financial condition. 5 Any material disruption in government operations and funding could have a material adverse impact on our business, financial condition, and results of operations. 6 A dependency on the payment behavior and decision-making of our business partners can affect the collectability of accounts receivable and impact our operating results. 7 Changes in reimbursement, payor mix and/or governmental regulations for healthcare could materially decrease our revenues and operating profit. 8 We operate in a highly regulated industry such that the potential for legislative reform provides uncertainty and potential threats to our operating models and results. 9 We could be adversely affected if we experience shortages of goods or material price increases from our suppliers, or an inability to access new and improved products and technology. 10 If we are unable to attract and retain skilled medical, technical, engineering or key strategic personnel, or if legislative, union, other labor-related activities or changes or employee absenteeism and turnover result in significant increases in our operating costs or decreases in productivity, we may be unable to manage our growth, continue our technological development or execute our strategy. 11 We operate in many different jurisdictions and we could be adversely affected by violations of the U.S.
For the purposes of management compensation, these metrics are also benchmarked at the underlying exchange rates used in the calculation of our incentive compensation targets. 81 Table of Contents We believe that the measures at Constant Currency are useful to investors, lenders and other creditors because such information enables them to gauge the impact of currency fluctuations on our revenue, operating income, net income attributable to shareholders of FME AG and other items from period to period.
For the purposes of management compensation, these metrics are also benchmarked at the underlying exchange rates used in the calculation of our incentive compensation targets. 68 Table of Contents We believe that the measures at Constant Currency are useful to investors, lenders, and other creditors because such information enables them to gauge the impact of currency fluctuations on our revenue, operating income, net income attributable to shareholders of FME AG, and other items from period to period.
We believe operating income margin shows the profitability of each of our operating segments and our company on a consolidated basis. 86 Table of Contents Net income and net income growth As net income represents the profitability of our business after all costs including operating costs, interest income and expense, taxes and the impacts of noncontrolling interests in our subsidiaries, this metric shows our profit for the period after taking into account all aspects of our business.
We believe operating income margin shows the profitability of each of our operating segments and our company on a consolidated basis. 72 Table of Contents Net income and net income growth As net income represents the profitability of our business after all costs including operating costs, interest income and expense, taxes, and the impacts of noncontrolling interests in our subsidiaries, this metric shows our profit for the period after taking into account all aspects of our business.
This indicator shows the percentage of revenue available for acquisitions and investments, dividends to shareholders, debt servicing and reductions in debt financing or for repurchasing shares.
This indicator shows the percentage of revenue available for acquisitions and investments, dividends to shareholders, debt servicing, reductions in debt financing, and for repurchasing shares.
Trend information For information regarding significant trends in our business see Item 5, “Operating financial review and prospects.” 108 Table of Contents IX. Tabular disclosure of contractual obligations The information required by this item may be found in Item 5B under the caption “– IV. Financial position net cash provided by (used in) financing activities.”
Trend information For information regarding significant trends in our business see Item 5, “Operating financial review and prospects.” 102 Table of Contents IX. Tabular disclosure of contractual obligations The information required by this item may be found in Item 5B under the caption “– IV. Financial position net cash provided by (used in) financing activities.”
We calculate and present these financial measures using both IFRS Accounting Standards and at constant exchange rates in our publications to show changes in these metrics and other items without giving effect to period-to-period currency fluctuations. Under IFRS Accounting Standards, amounts received in local (non-euro) currency are translated into euro at the average exchange rate for the period presented.
We calculate and present these financial measures using both IFRS Accounting Standards and at constant exchange rates to show changes in these metrics and other items without giving effect to period-to-period currency fluctuations. Under IFRS Accounting Standards, amounts received in local (non-euro) currency are translated into euro at the average exchange rate for the period presented.
Performance management system” above. Key Performance Indicators The following discussions include our two operating and reportable segments and the measures we use to manage these segments.
Performance management system” above. Key Performance Indicators The following discussions include our operating and reportable segments and the measures we use to manage these segments.
Financial position,” Item 11, “Quantitative and qualitative disclosures about market risk Market risk” and note 26 of the notes to the consolidated financial statements included in this report. 15 Legal and regulatory matters (see note 25 of the notes to the consolidated financial statements included in this report). 16 Diverging views of fiscal authorities or changes in tax legislation could require us to make additional tax payments. 17 As a company with operations spanning around 150 countries, we face specific risks from our global operations. 18 We are subject to risks associated with unpredictable events, such as public health crises and epidemics/pandemics or other significant events beyond our control. 19 Global economic conditions as well as disruptions in financial markets could have an adverse effect on our businesses. 20 If we are unable to meet applicable legal requirements and/or market expectations with respect to sustainability, both our business and our reputation could suffer.
Financial position,” Item 11, “Quantitative and qualitative disclosures about market risk Market risk” and note 26 of the notes to the consolidated financial statements included in this report. 15 Legal and regulatory matters (see note 25 of the notes to the consolidated financial statements included in this report). 16 Diverging views of fiscal authorities or changes in tax legislation could require us to make additional tax payments. 17 As a company with operations spanning more than 140 countries, we face specific risks from our global operations. 18 We are subject to risks associated with unpredictable events, such as public health crises and epidemics/pandemics or other significant events beyond our control. 19 Global economic conditions as well as disruptions in financial markets could have an adverse effect on our businesses. 20 If we are unable to meet applicable legal requirements and/or market expectations with respect to sustainability, both our business and our reputation could suffer.
We utilize this evaluation methodology to ensure that we only make and implement investments and acquisitions that increase shareholder value. Capital expenditures for property, plant and equipment and capitalized development costs is an indicator used for internal management. It influences the capital invested for replacement and expansion.
We utilize this evaluation methodology to ensure that we only make and implement investments and acquisitions that increase shareholder value. Capital expenditures for property, plant, and equipment and capitalized development costs is an indicator used for internal management. The measure influences the capital invested for replacement and expansion.
In the following table, we have listed certain risks and the corresponding risk factor (or other discussion of such risks) within this report as well as our assessment of the reasonable probability and potential impact of these known risks on our results for the FY 2025.
In the following table, we have listed certain risks and the corresponding risk factor (or other discussion of such risks) within this report as well as our assessment of the reasonable probability and potential impact of these known risks on our results for the FY 2026.
The decrease in net cash provided by operating activities in percent of revenue as compared to the year ended 2023 was driven by a negative impact from the phasing of dividend payments received from equity method investments and the absence, in 2024, of the Tricare Settlement, partially offset by a favorable effect from certain working capital items (mainly accounts receivable from related parties and inventories).
The decrease in net cash provided by operating activities in percent of revenue for the year ended December 31, 2024 as compared to the year ended December 31, 2023 was driven by a negative impact from the phasing of dividend payments received from equity method investments and the absence, in 2024, of the Tricare Settlement, partially offset by a favorable effect from certain working capital items (mainly accounts receivable from related parties and inventories).
Results of operations, financial position and net assets Highlights The following items represent notable impacts or trends in our business and/or industry for the year ended December 31, 2024: Legacy Portfolio Optimization We continue to review our business portfolio, specifically with a view to exiting unsustainable markets and divesting non-core businesses and 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.
Results of operations, financial position and net assets Highlights The following items represent notable impacts or trends in our business and/or industry for the year ended December 31, 2025: Legacy Portfolio Optimization and FME25+ Program We continue to review our business portfolio, specifically with a view to exiting unsustainable markets and divesting non-core businesses and 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.
Operating and financial review and prospects IV. Financial position Sources of liquidity.” Capital expenditures We manage our investments using a detailed coordination and evaluation process. The Management Board sets our complete investment budget as well as the investment targets.
Operating and financial review and prospects IV. Financial position Sources of liquidity.” Capital expenditures We manage our investments using a detailed coordination and evaluation process. The Management Board sets our complete investment budget and targets.
Financial condition and results of operations Overview” above. We intend to continue to address our current cash and financing requirements using net cash provided by operating activities, issuances under our commercial paper program (see note 16 of the notes to the consolidated financial statements included in this report) as well as from the use of our bilateral credit lines.
Financial condition and results of operations Overview,” above. We intend to continue to address our current cash and financing requirements using net cash provided by operating activities, issuances under our commercial paper program (see note 16 of the notes to the consolidated financial statements included in this report), as well as from the use of our bilateral credit lines.
For a reconciliation of cash flow performance indicators for the years ended 2024, 2023 and 2022 which reconciles free cash flow and free cash flow in percent of revenue to Net cash provided by (used in) operating activities and Net cash provided by (used in) operating activities in percent of revenue, see “Item 5.
For a reconciliation of cash flow performance indicators for the years ended 2025, 2024, and 2023, which reconciles free cash flow and free cash flow in percent of revenue to Net cash provided by (used in) operating activities and Net cash provided by (used in) operating activities in percent of revenue, see “Item 5.
We do not use financial instruments for trading or other speculative purposes (for financial risks, see Item 11. “Quantitative and qualitative disclosures about market risk Management of foreign exchange and interest rate risks” below as well as note 26 of the notes to the consolidated financial statements included in this report).
We do not use financial instruments for trading or other speculative purposes (for financial risks as well as information regarding vPPAs, see Item 11. “Quantitative and qualitative disclosures about market risk Management of foreign exchange and interest rate risks” below as well as note 26 of the notes to the consolidated financial statements included in this report).
In general, government-funded programs (in some countries in coordination with private insurers) pay for certain health care items and services provided to their citizens. Not all health care systems provide payment for dialysis treatment. Therefore, the reimbursement systems and ancillary services utilization environment in various countries significantly influence our business.
In general, government-funded programs (in some countries in coordination with private insurers) pay for certain healthcare items and services provided to their citizens. Not all healthcare systems provide payment for dialysis treatment. Therefore, the reimbursement systems and ancillary services utilization environment in various countries significantly influence our business.
(Humacyte Remeasurements), iii. certain costs associated with the Conversion, primarily related to the requisite relabeling of our products, transaction costs (such as costs for external advisors and conducting an extraordinary general meeting) and costs related to the establishment of dedicated administrative functions required to manage certain services which have historically been administered at the Fresenius SE group level and paid by the Company through corporate charges (Legal Form Conversion Costs), and iv. impacts from strategic divestitures identified during our Legacy Portfolio Optimization review.
(Humacyte Remeasurements), iii. certain costs associated with the Conversion, primarily related to the requisite relabeling of our products, transaction costs (such as costs for external advisors and conducting an extraordinary general meeting) and costs related to the establishment of dedicated administrative functions required to manage certain services which have historically been administered at the Fresenius SE group level and paid by the Company through corporate charges (Legal Form Conversion Costs), and iv. costs incurred in relation to strategic divestitures identified during our Legacy Portfolio Optimization review.
Performance management system Net leverage ratio (Non-IFRS Measure)” above) and in the amount of €1.0 M and €0.9 M for the twelve months ended December 31, 2024 and December 31, 2023, respectively to include sales or value-added tax and other smaller effects.
Performance management system Net leverage ratio (Non-IFRS Measure)” above) and in the amount of €1.1 M and €1.0 M for the twelve months ended December 31, 2025 and December 31, 2024, respectively to include sales or value-added tax and other smaller effects.
Additionally, daily revenues in the amount of €(0.6) M and €(0.4) M for the twelve months ended December 31, 2024 and December 31, 2023, respectively, are adjusted in relation to amounts related to acquisitions and divestitures made within the reporting period with a purchase price above a €50 M threshold, to increase consistency with the respective adjustments in the determination of adjusted EBITDA (See “— I.
Additionally, daily revenues in the amount of €(0.1) M and €(0.6) M for the twelve months ended December 31, 2025 and December 31, 2024, respectively, are adjusted in relation to amounts related to acquisitions and divestitures made within the reporting period with a purchase price above a €50 M threshold, to increase consistency with the respective adjustments in the determination of adjusted EBITDA (See “— I.
We also develop, manufacture and distribute a wide variety of health care products. Our health care products include hemodialysis machines, peritoneal dialysis cyclers, dialyzers, peritoneal dialysis solutions, hemodialysis concentrates, solutions and granulates, bloodlines, renal pharmaceuticals, systems for water treatment, as well as acute cardiopulmonary and apheresis products.
We also develop, manufacture, and distribute a wide variety of healthcare products. Our healthcare products include hemodialysis machines, peritoneal dialysis cyclers, dialyzers, peritoneal dialysis solutions, hemodialysis concentrates, solutions and granulates, bloodlines, renal pharmaceuticals, systems for water treatment, as well as acute cardiopulmonary and apheresis products.
Because of the non-discretionary nature of the health care services we provide, the need for health care products utilized to provide such services and the availability of government reimbursement for a substantial portion of our health care services, our business is generally not cyclical. A substantial portion of our accounts receivable is generated by governmental payors.
Because of the non-discretionary nature of the healthcare services we provide, the need for healthcare products utilized to provide such services, and the availability of government reimbursement for a substantial portion of our healthcare services, our business is generally not cyclical. A substantial portion of our accounts receivable is generated by governmental payors.
To the extent that increases in operating costs that are affected by inflation, such as labor and supply costs, are not fully reflected in a compensating increase in reimbursement rates, our business and results of operations would be adversely affected. In addition, the U.S.
To the extent that increases in operating costs that are affected by inflation, such as labor and supply costs, are not fully reflected in a compensating increase in reimbursement rates, our business and results of operations would be adversely affected.
However, limited or expensive access to capital could make it more difficult for our customers to do business with us, or to do business generally, which could adversely affect our business by causing our customers to reduce or delay their purchases of our health care products (see “III.
However, limited or expensive access to capital could make it more difficult for our customers to do business with us, or to do business generally, which could adversely affect our business by causing our customers to reduce or delay their purchases of our healthcare products (see “III.
Refinancing risks are limited due to the Company’s balanced maturity profile, which is characterized by a wide range of maturities of up to 2031. Corporate bonds in euro and U.S. dollar form the basis of our mid- and long-term financing instruments. Corporate bonds in euro are issued under our €10 billion debt issuance program.
Refinancing risks are limited due to the Company’s balanced maturity profile, which is characterized by a wide range of maturities of up to 2032. Corporate bonds in euro and U.S. dollar form the basis of our mid- and long-term financing instruments. Corporate bonds in euro are issued under our €10 BN debt issuance program.
The following chart summarizes our significant long-term financing instruments as well as their maturity structure at December 31, 2024: 100 Table of Contents For a description of our short-term debt, long-term sources of liquidity and contractual cash flows (including interest) resulting from recognized financial liabilities and derivative financial instruments recorded in the consolidated balance sheets, see notes 16, 17 and 26 of the notes to the consolidated financial statements included in this report.
The following chart summarizes our significant long-term financing instruments as well as their maturity structure at December 31, 2025: For a description of our short-term debt, long-term sources of liquidity, and contractual cash flows (including interest) resulting from recognized financial liabilities and derivative financial instruments recorded in the consolidated balance sheets, see notes 16, 17, and 26 of the notes to the consolidated financial statements included in this report.
The decrease in research and development expense for the year ended December 31, 2024 as compared to the prior year comparable period was largely driven by lower personnel costs for R&D projects, higher capitalization of development costs and lower costs related to activities in the field of regenerative medicine, partially offset by increased R&D activity.
The decrease in research and development expense for the year ended December 31, 2024 as compared to the year ended December 31, 2023 was largely driven by lower personnel costs for R&D projects, higher capitalization of development costs, and lower costs related to activities in the field of regenerative medicine, partially offset by increased R&D activity.
Goodwill, included in the item “Invested capital,” has a significant impact on the calculation of ROIC. The weighted average cost of capital (WACC), including weighted risk premiums for country risks, was 6.3%. See “— I. Performance management system Return on invested capital (ROIC) (Non-IFRS Measure)” above.
Goodwill, included in the item “Invested capital,” has a significant impact on the calculation of ROIC. The weighted average cost of capital (WACC), including weighted risk premiums for country risks, was 7.0%. See “— I. Performance management system Return on invested capital (ROIC) (Non-IFRS Measure)” above.
Inter-segment eliminations (17) (13) 30 5 25 Corporate (48) (67) (29) (1) (28) Operating income (loss) margin 7.2 7.0 Care Delivery segment 7.8 9.7 Care Enablement segment 4.8 (1.2) (1) For further information on Constant Exchange Rates, see “I.
Inter-segment eliminations (17) (13) 30 5 25 Corporate (48) (67) (29) (1) (28) Operating income (loss) margin 7.2 7.0 Care Delivery segment 8.7 10.9 Value-Based Care segment (1.6) (7.5) Care Enablement segment 4.8 (1.2) (1) For further information on Constant Exchange Rates, see “I.
Divestitures in 2024 mainly related to the divestment of equity investments (including divestitures under our Legacy Portfolio Optimization program) and debt securities. 99 Table of Contents Investments in 2023 were primarily comprised of purchases of debt securities. Divestitures in 2023 were mainly related to the divestment of equity investments (including divestitures under our Legacy Portfolio Optimization program) and debt securities.
Investments in 2024 were primarily comprised of purchases of debt securities and equity investments. Divestitures in 2024 were mainly related to the divestment of equity investments (including divestitures under our Legacy Portfolio Optimization program) and debt securities. Investments in 2023 were primarily comprised of purchases of debt securities.
As of December 31, 2024, our available borrowing capacity under unutilized credit facilities amounted to approximately €3.5 billion, including €2.0 billion under the Syndicated Credit Facility, which we maintain as a backup for general corporate purposes (see note 17 of the notes to the consolidated financial statements included in this report).
As of December 31, 2025, our available borrowing capacity under unutilized credit facilities amounted to approximately €3.3 BN, including €2.0 BN under the Syndicated Credit Facility, which we maintain as a backup for general corporate purposes (see note 17 of the notes to the consolidated financial statements included in this report).
For short-term financing we use our €1.5 billion commercial paper program and bilateral credit lines.
For short-term financing we use our €1.5 BN commercial paper program and bilateral credit lines.
For information regarding litigation exposure as well as ongoing and future tax audits, see note 25 of the notes to the consolidated financial statements included in this report. Net cash provided by (used in) investing activities Net cash used in investing activities in 2024 and 2023 was €85 M and €544 M, respectively.
For information regarding litigation exposure as well as ongoing and future tax audits, see note 25 of the notes to the consolidated financial statements included in this report. 91 Table of Contents Net cash provided by (used in) investing activities Net cash used in investing activities in 2025, 2024, and 2023 was €723 M, €85 M, and €544 M, respectively.
The following table summarizes our available sources of liquidity at December 31, 2024: Available sources of liquidity in M Expiration per period of Less than 1 Total year 1-3 years 3-5 years Over 5 years Syndicated Credit Facility 2,000 2,000 Other unused lines of credit 1,508 938 570 3,508 938 570 2,000 An additional source of liquidity is our commercial paper program, under which up to €1,500 M of short-term notes can be issued on a flexible and continuous basis.
The following table summarizes our available sources of liquidity at December 31, 2025: Available sources of liquidity in M Expiration per period of Less than 1 Total year 1-3 years 3-5 years Over 5 years Syndicated Credit Facility 2,000 2,000 Other unused lines of credit 1,307 997 310 3,307 997 2,310 An additional source of liquidity is our commercial paper program, under which up to €1,500 M of short-term notes can be issued on a flexible and continuous basis.
In order to ensure comparability of line items included in the consolidated balance sheets and consolidated statements of income, trade accounts and other receivables from unrelated parties (including receivables related to assets held for sale) and contract liabilities as of December 31, 2024 are adjusted for a decrease in the amount of €78.5 M and an increase in the amount of €1.5 M, respectively (December 31, 2023: an increase of €65.2 M and €2.0 M, respectively), which represents the impact on these line items from foreign currency translation.
In order to ensure comparability of line items included in the consolidated balance sheets and consolidated statements of income, trade accounts and other receivables from unrelated parties (including receivables related to assets held for sale) and contract liabilities as of December 31, 2025 are adjusted for an increase in the amount of €101.3 M and €3.7 M, respectively (December 31, 2024: a decrease of €78.5 M and an increase of €1.5 M, respectively), which represents the impact on these line items from foreign currency translation.
Consolidated Revenue decreased as compared to the year ended December 31, 2023 primarily driven by the effect of closed or sold operations (primarily related to Legacy Portfolio Optimization), the absence, in 2024, of a settlement agreement in 2023 related to a previous complaint we filed against the U.S. government in 2019 which sought to recover amounts owed to us under the Tricare program (Tricare Settlement) and a negative impact from foreign currency translation, partially offset by an increase in organic growth in both Care Delivery and Care Enablement. 92 Table of Contents Care Delivery The decrease in Care Delivery revenue as compared to the year ended December 31, 2023 was driven by the effect of closed or sold operations (primarily related to Legacy Portfolio Optimization) and the absence, in 2024, of the Tricare Settlement, partially offset by an increase in organic growth.
Consolidated Revenue decreased as compared to the year ended December 31, 2023, primarily driven by the effect of closed or sold operations (primarily related to Legacy Portfolio Optimization), the absence, in 2024, of a settlement agreement in 2023 related to a previous complaint we filed against the U.S. government in 2019 which sought to recover amounts owed to us under the Tricare program (Tricare Settlement) and a negative impact from foreign currency translation, partially offset by an increase in organic growth in both all segments.
During the past fiscal year, the focus of our investing activities was on our health care services business. Financing strategy Our financing strategy aims at ensuring financial flexibility, managing financial risks and optimizing financing costs. Financial flexibility is ensured through maintaining sufficient liquidity.
During the past fiscal year, the focus of our investing activities was on our healthcare products business. Financing strategy Our financing strategy aims at ensuring financial flexibility, managing financial risks, and optimizing financing costs. Financial flexibility is ensured through maintaining sufficient liquidity.
Operating income is also benchmarked based on movement at Constant Exchange Rates (Non-IFRS Measure). 82 Table of Contents Secondary financial performance indicators Return on invested capital (ROIC) (Non-IFRS Measure) ROIC is the ratio of operating income, for the last twelve months, after tax (net operating profit after tax or NOPAT) to the average invested capital of the last five quarter closing dates, including adjustments for acquisitions and divestitures made during the last twelve months with a purchase price above a €50 M threshold, consistent with the respective adjustments made in the determination of adjusted EBITDA (earnings before interest, taxes, depreciation and amortization) below (see “Net leverage ratio (Non-IFRS Measure)”).
Secondary financial performance indicators Return on invested capital (ROIC) (Non-IFRS Measure) ROIC is the ratio of operating income, for the last twelve months, after tax (net operating profit after tax or NOPAT) to the average invested capital of the last five quarter closing dates, including adjustments for acquisitions and divestitures made during the last twelve months with a purchase price above a €50 M threshold, consistent with the respective adjustments made in the determination of adjusted EBITDA (earnings before interest, taxes, depreciation, and amortization) below (see “Net leverage ratio (Non-IFRS Measure)”).
On May 22, 2024, we paid a dividend with respect to 2023 of €1.19 per share (€1.12 per share for 2022 paid in 2023). The total dividend payments in 2024 and 2023 were €349 M and €329 M, respectively.
On May 27, 2025, we paid a dividend with respect to 2024 of €1.44 per share (€1.19 per share for 2023 paid in 2024 and €1.12 per share for 2022 paid in 2023). The total dividend payments in 2025, 2024, and 2023 were €423 M, €349 M and €329 M, respectively.
In 2023, cash was mainly used in the repayment of lease liabilities (including lease liabilities from related parties), the repayment of long-term debt (including the repayment at maturity of bonds in an aggregate principal amount of €650 M), the payment of dividends, distributions to noncontrolling interests and the repayment of short-term debt (including borrowings under our commercial paper program and short-term debt from related parties), partially offset by proceeds from long-term debt and short-term debt (including borrowings under our commercial paper program and short-term debt from related parties).
In 2024, cash was mainly used in the repayment of debt (including short and long-term debt, the accounts receivable securitization program as well as lease liabilities), payment of dividends and distributions to noncontrolling interests. 92 Table of Contents In 2023, cash was mainly used in the repayment of lease liabilities (including lease liabilities from related parties), the repayment of long-term debt (including the repayment at maturity of bonds in an aggregate principal amount of €650 M), the payment of dividends, distributions to noncontrolling interests and the repayment of short-term debt (including borrowings under our commercial paper program and short-term debt from related parties), partially offset by proceeds from long-term debt and short-term debt (including borrowings under our commercial paper program and short-term debt from related parties).
For the year ended December 31, 2024, approximately 78% of our revenue was generated by providing health care services, a major portion of which is reimbursed by either public health care organizations or private insurers. In 2024, approximately 18% of our consolidated revenue was attributable to reimbursements from U.S. federal health care benefit programs such as Medicare and Medicaid.
For the year ended December 31, 2025, approximately 78% of our revenue was generated by providing healthcare services (including insurance services), a major portion of which is reimbursed by either public healthcare organizations or private insurers. In 2025, approximately 16% of our consolidated revenue was attributable to reimbursements from U.S. federal healthcare benefit programs such as Medicare and Medicaid.
We require this capital primarily to finance working capital needs, fund the FME25 Program and acquisitions, operate clinics, develop free-standing renal dialysis clinics and other health care facilities, purchase equipment for existing or new renal dialysis clinics and production sites, repay debt and pay dividends (see “Net cash provided by (used in) investing activities” and “Net cash provided by (used in) financing activities” below) and to satisfy put option obligations to holders of minority interests in our majority-owned subsidiaries.
We require this capital primarily to finance working capital needs, fund the FME25+ Program and acquisitions, operate clinics, develop free-standing renal dialysis clinics and other healthcare facilities, purchase equipment for existing or new renal dialysis clinics and production sites, repay debt, pay dividends, repurchase shares (see “Net cash provided by (used in) investing activities” and “Net cash provided by (used in) financing activities” below), and to satisfy put option obligations to holders of minority interests in our majority-owned subsidiaries (see note 26 of the notes to the consolidated financial statements included in this report).
As of December 31, 2024, we did not utilize the commercial paper program. As of December 31, 2023, we utilized €400 M of the commercial paper program. At December 31, 2024, we had short-term debt from unrelated parties (excluding the current portion of long-term debt) in the total amount of €2 M.
As of December 31, 2025 and 2024, we did not utilize the commercial paper program. At December 31, 2025, we had short-term debt from unrelated parties (excluding the current portion of long-term debt) in the total amount of €17 M.
Business overview.” 89 Table of Contents Presently, there is considerable uncertainty regarding possible future changes in health care regulation, including the regulation of reimbursement for dialysis services. As a consequence of the pressure to decrease health care costs, government reimbursement rate increases in the U.S. have historically been limited and are expected to continue in this fashion.
Sequestration.” Presently, there is considerable uncertainty regarding possible future additional changes in healthcare regulation, including the regulation of reimbursement for dialysis services. As a consequence of the pressure to decrease healthcare costs, government reimbursement rate increases in the U.S. have historically been limited and are expected to continue in this fashion.
The increase in net income attributable to shareholders of FME AG was as a result of the combined effects of the items discussed above. Basic earnings per share increased primarily due to the increase in net income attributable to shareholders of FME AG described above.
The increase in net income attributable to shareholders of FME AG resulted from the combined effects of the items discussed above. Basic earnings per share increased primarily due to the increase in net income attributable to shareholders of FME AG described above.
Dialysis patient growth results from factors such as the aging population and increased life expectancies; shortage of donor organs for kidney transplants; increasing incidence of kidney disease and better treatment of and survival of patients with diabetes, hypertension and other illnesses, which frequently lead to the onset of CKD; improvements in treatment quality, new pharmaceuticals and product technologies, which prolong patient life; and improving standards of living in developing countries, which make life-saving dialysis treatment available.
Dialysis patient growth results from factors such as: aging populations and increased life expectancies; shortage of donor organs for kidney transplants; increasing incidence of kidney disease; better treatment and survival of patients with diabetes, hypertension, and other illnesses, which frequently lead to the onset of CKD; improvements in treatment quality, new pharmaceuticals, and product technologies, which prolong patient life; and improving standards of living in developing countries, which make life-saving dialysis treatment available. 75 Table of Contents We are also engaged in different areas of healthcare product therapy research.
Performance management system Net cash provided by (used in) operating activities in % of revenue” and Free cash flow in % of revenue (Non-IFRS Measure)” above. 97 Table of Contents The following table shows the cash flow performance indicators for the years ended December 31, 2024, and 2023 and reconciles free cash flow and free cash flow in percent of revenue to Net cash provided by (used in) operating activities and Net cash provided by (used in) operating activities in percent of revenue, respectively: Cash flow measures in M, except where otherwise specified 2024 2023 Revenue 19,336 19,454 Net cash provided by (used in) operating activities 2,386 2,629 Capital expenditures (699) (685) Proceeds from sale of property, plant and equipment 14 16 Capital expenditures, net (685) (669) Free cash flow 1,701 1,960 Net cash provided by (used in) operating activities in % of revenue 12.3 13.5 Free cash flow in % of revenue 8.8 10.1 Net cash provided by (used in) operating activities Net cash provided by (used in) operating activities is impacted by the profitability of our business, the development of our working capital, principally inventories, receivables and cash outflows that occur due to a number of specific items as discussed below.
The following table shows the cash flow performance indicators for the years ended December 31, 2025, 2024, and 2023 and reconciles free cash flow to Net cash provided by (used in) operating activities, the most directly comparable IFRS Accounting Standards measure, and free cash flow in percent of revenue to Net cash provided by (used in) operating activities in percent of revenue: Cash flow measures in M, except where otherwise specified 2025 2024 2023 Revenue 19,628 19,336 19,454 Net cash provided by (used in) operating activities 2,681 2,386 2,629 Capital expenditures (915) (699) (685) Proceeds from sale of property, plant and equipment 16 14 16 Capital expenditures, net (899) (685) (669) Free cash flow 1,782 1,701 1,960 Net cash provided by (used in) operating activities in % of revenue 13.7 12.3 13.5 Free cash flow in % of revenue 9.1 8.8 10.1 Net cash provided by (used in) operating activities Net cash provided by (used in) operating activities is impacted by the profitability of our business, the development of our working capital, principally inventories and receivables, and cash outflows that occur due to a number of specific items as discussed below.
Net interest expense remained relatively stable at €335 M from €336 M as a favorable impact from refinancing activities and favorable effects from foreign currency swaps were mostly offset by higher net interest expense on taxes related to a settlement, lower interest associated with receivables related to a royalty stream that we are entitled to base on sales made by Humacyte, Inc. in the U.S., a negative impact from the Third-party Cyber Incident and unfavorable foreign currency translation effects.
Net interest expense remained relatively stable at €335 M from €336 M as a favorable impact from refinancing activities and favorable effects from foreign currency swaps were mostly offset by higher net interest expense on taxes related to a settlement, lower interest associated with receivables related to a royalty stream that we are entitled to base on sales made by Humacyte, Inc. in the U.S., a negative impact from the cyber attack on one of our third party service providers leading to a shutdown of its financial clearinghouse service systems resulting in a delay in claims processing (the Third-party Cyber Incident), and unfavorable foreign currency translation effects.
Financial condition and results of operations Overview We are the world’s leading provider of products and services for individuals with renal diseases based on publicly reported revenue and number of patients treated. We provide dialysis and related services for individuals with renal diseases as well as other health care services.
Financial condition and results of operations Overview We are the world’s leading provider of products and services for individuals with renal diseases, based on publicly reported revenue. We provide dialysis and related services for individuals with renal diseases, including through value and risk-based care programs, as well as other healthcare services.
The key financial risks we are exposed to include foreign exchange risk and interest rate risk. To manage these risks, we enter into various hedging transactions that have been authorized by the Management Board. Counterparty risks are managed via internal credit limits, taking into account the external credit ratings of the respective hedging counterparty.
To manage these risks, we enter into various hedging transactions that have been authorized by the Management Board. Counterparty risks are managed via internal credit limits, taking into account the external credit ratings of the respective hedging counterparty.
The following table shows the reconciliation of net debt and adjusted EBITDA and the calculation of the net leverage ratio as of December 31, 2024 and 2023. Reconciliation of adjusted EBITDA and net leverage ratio to the most directly comparable IFRS Accounting Standards financial measure in M, except for net leverage ratio December 31, December 31, 2024 2023 Debt and lease liabilities (1) 10,988 12,187 Minus: Cash and cash equivalents (2) (1,185) (1,427) Net debt 9,803 10,760 Net income 741 732 Income tax expense 316 301 Interest income (72) (88) Interest expense 407 424 Depreciation and amortization 1,536 1,613 Adjustments (3) 450 409 Adjusted EBITDA 3,378 3,391 Net leverage ratio 2.9 3.2 (1) Debt includes the following balance sheet line items: short-term debt, current portion of long-term debt and long-term debt, less current portion as well as debt and lease liabilities included within liabilities directly associated with assets held for sale.
The following table shows the reconciliation of net debt and adjusted EBITDA and the calculation of the net leverage ratio as of December 31, 2025 and 2024. 88 Table of Contents Reconciliation of adjusted EBITDA and net leverage ratio to the most directly comparable IFRS Accounting Standards financial measure in M, except for net leverage ratio December 31, December 31, 2025 2024 Debt and lease liabilities (1) 10,795 10,988 Minus: Cash and cash equivalents (2) (1,599) (1,185) Net debt 9,196 9,803 Net income 1,191 741 Income tax expense 321 316 Interest income (70) (72) Interest expense 385 407 Depreciation and amortization 1,463 1,536 Adjustments (3) 447 450 Adjusted EBITDA 3,737 3,378 Net leverage ratio 2.5 2.9 (1) Debt includes the following balance sheet line items: short-term debt, current portion of long-term debt, long-term debt, less current portion, and debt and lease liabilities included within liabilities directly associated with assets held for sale.
The €2 billion Syndicated Credit Facility serves as a backup facility and was undrawn at December 31, 2024. 95 Table of Contents The following chart summarizes our main financing debt mix as of December 31, 2024: In our long-term capital management, we focus primarily on the net leverage ratio, a Non-IFRS measure, see “I.
The €2 BN Syndicated Credit Facility serves as a backup facility and was undrawn at December 31, 2025. 87 Table of Contents The following chart summarizes our main financing debt mix as of December 31, 2025: In our long-term capital management, we focus primarily on the net leverage ratio, a Non-IFRS measure, and manage against our self-imposed target of 2.5x - 3.0x (see “I.
We are also engaged in different areas of health care product therapy research. As a global company delivering health care services and products, we face the challenge of addressing the needs of a wide variety of stakeholders, such as patients, customers, payors, regulators and legislators in many different economic environments and health care systems.
As a global company delivering healthcare services and products, we face the challenge of addressing the needs of a wide variety of stakeholders, such as patients, customers, payors, regulators, and legislators in many different economic environments and healthcare systems.
In China, pricing was negatively impacted by volume-based procurement. Operating income (loss) in M Change in % Currency translation Constant 2024 2023 As reported effects Currency (1) Operating income (loss) 1,392 1,369 2 (1) 3 Care Delivery segment 1,190 1,516 (22) (1) (21) Care Enablement segment 267 (67) n.a. n.a.
In China, pricing was negatively impacted by volume-based procurement. Operating income (loss) in M Change in % Currency translation Constant 2024 2023 As reported effects Currency (1) Operating income (loss) 1,392 1,369 2 (1) 3 Care Delivery segment 1,218 1,612 (24) 0 (24) Value-Based Care segment (28) (96) (71) 0 (71) Care Enablement segment 267 (67) n.a. n.a.
As a significant portion of our operations are derived from our businesses in the U.S., the development of the euro against the U.S. dollar can have a material impact on our results of operations, financial position and net assets and the impacts of foreign currency transaction and translation effects are included in the discussion of our key and secondary performance indicators below. 91 Table of Contents Year ended December 31, 2024 compared to year ended December 31, 2023 Results of operations in M Change in % Currency translation Constant 2024 2023 As reported effects Currency (1) Revenue 19,336 19,454 (1) (1) 0 Costs of revenue (14,579) (14,529) 0 1 1 Selling, general and administrative costs (3,143) (3,196) (2) 1 (1) Research and development (183) (232) (21) 0 (21) Income from equity method investees 135 122 11 0 11 Other operating income 760 515 48 0 48 Other operating expense (934) (765) 22 1 23 Operating income 1,392 1,369 2 (1) 3 Operating income margin 7.2 7.0 Interest income 72 88 (19) (1) (18) Interest expense (407) (424) (4) 0 (4) Income tax expense (316) (301) 5 1 6 Net income 741 732 1 (1) 2 Net income attributable to noncontrolling interests (203) (233) (13) 0 (13) Net income attributable to shareholders of FME AG 538 499 8 (1) 9 Basic and diluted earnings per share in 1.83 1.70 8 (1) 9 (1) For further information on Constant Exchange Rates, see “I.
As a significant portion of our operations are derived from our businesses in the U.S., the development of the euro against the U.S. dollar can have a material impact on our results of operations, financial position and net assets and the impacts of foreign currency transaction and translation effects are included in the discussion of our key and secondary performance indicators below. 78 Table of Contents Year ended December 31, 2025 compared to year ended December 31, 2024 Results of operations in M Change in % Currency translation Constant 2025 2024 As reported effects Currency (1) Revenue 19,628 19,336 2 (3) 5 Costs of revenue (14,599) (14,579) 0 4 4 Selling, general and administrative costs (3,033) (3,143) (4) 4 0 Research and development (158) (183) (14) 1 (13) Income from equity method investees 181 135 34 1 35 Other operating income 528 760 (31) (2) (29) Other operating expense (720) (934) (23) 2 (21) Operating income 1,827 1,392 31 (5) 36 Operating income margin 9.3 7.2 Interest income 70 72 (3) (5) 2 Interest expense (385) (407) (6) 4 (2) Income tax expense (321) (316) 2 2 4 Net income 1,191 741 61 (5) 66 Net income attributable to noncontrolling interests (213) (203) 5 4 9 Net income attributable to shareholders of FME AG 978 538 82 (6) 88 Basic and diluted earnings per share in 3.36 1.83 83 (6) 89 (1) For further information on Constant Exchange Rates, see “I.
For our self-set target range for the net leverage ratio and a reconciliation of adjusted EBITDA and net leverage ratio as of December 31, 2024 and 2023, see “Item 5. Operating and financial review and prospects IV. Financial position Financing strategy.” 88 Table of Contents II.
For our self-set target range for the net leverage ratio and a reconciliation of adjusted EBITDA and net leverage ratio as of December 31, 2025 and 2024, see “Item 5. Operating and financial review and prospects IV.
For further information, see note 29 of the notes to the consolidated financial statements included in this report. Revenue in M, except dialysis treatment, patient and clinic data Change in % Currency Same Market translation Constant Organic Treatment 2024 2023 As reported effects Currency (1) growth Growth (2) Revenue 19,336 19,454 (1) (1) 0 4 Care Delivery segment 15,275 15,578 (2) 0 (2) 4 0.3 Thereof: U.S. 12,798 12,665 1 0 1 4 (0.1) Thereof: International 2,477 2,913 (15) (2) (13) 4 1.4 Care Enablement segment 5,557 5,345 4 (1) 5 5 Inter-segment eliminations (1,496) (1,469) 2 0 2 Dialysis treatments 47,617,071 51,654,540 (8) Patients 299,352 332,548 (10) Clinics 3,675 3,925 (6) (1) For further information on Constant Exchange Rates, see “I.
For further information, see note 1 and note 29 of the notes to the consolidated financial statements included in this report. Revenue in M, except dialysis treatment, patient and clinic data Change in % Same Currency Market translation Constant Organic Treatment 2024 2023 As reported effects Currency (1) growth Growth (2) Revenue 19,336 19,454 (1) (1) 0 4 Care Delivery segment 14,003 14,749 (5) 0 (5) 1 0.3 Thereof: U.S. 11,526 11,836 (3) 0 (3) 0 (0.1) Thereof: International 2,477 2,913 (15) (2) (13) 4 1.4 Value-Based Care segment 1,752 1,277 37 0 37 37 Care Enablement segment 5,557 5,345 4 (1) 5 5 Inter-segment eliminations (1,976) (1,918) 3 0 3 Thereof: Care Delivery (3) (480) (448) 7 0 7 Thereof: Care Enablement (3) (1,496) (1,469) 2 0 2 Dialysis treatments 47,617,071 51,654,540 (8) Patients 299,352 332,548 (10) Clinics 3,675 3,925 (6) Member Months 1,534,053 1,330,582 15 Membership 131,750 122,242 8 (1) For further information on Constant Exchange Rates, see “I.
The following table shows a breakdown of our investing activities for 2024 and 2023: Cash flows relating to investing activities in M Acquisitions, investments, Capital expenditures, net, purchases of intangible Proceeds from divestitures including capitalized assets and investments in and the sale of debt development costs debt securities securities 2024 2023 2024 2023 2024 2023 Care Delivery 353 330 37 55 658 195 Care Enablement 332 339 68 82 47 67 Total 685 669 105 137 705 262 The majority of our capital expenditures was used for maintaining existing clinics and centers, capitalization of machines provided to our customers, capitalization of certain development costs, expansion of production capacity and equipping new clinics and centers.
The following table shows a breakdown of our investing activities for 2025, 2024, and 2023: Cash flows relating to investing activities in M Acquisitions, investments, Capital expenditures, net, including purchases of intangible assets and Proceeds from divestitures and the capitalized development costs investments in debt securities sale of debt securities 2025 2024 2023 2025 2024 2023 2025 2024 2023 Care Delivery 321 352 329 49 35 55 226 658 194 Value-Based Care 1 1 1 0 2 0 1 Care Enablement 577 332 339 60 68 82 59 47 67 Total 899 685 669 109 105 137 285 705 262 The majority of our capital expenditures was used for the expansion of production capacity (including the purchase of previously leased facilities), capitalization of certain development costs, capitalization of machines provided to our customers, maintaining existing clinics and centers, and equipping new clinics and centers.
Although we believe our FY 2025 outlook, which we issued in connection with the announcement of our results for the 2024 fiscal year, is based on reasonable assumptions, it is subject to risks and uncertainties that may materially impact the achievement of the outlook.
A summary of such risk assessment is set forth below. 94 Table of Contents Although we believe our FY 2026 outlook, which we issued in connection with the announcement of our results for the 2025 fiscal year, is based on reasonable assumptions, it is subject to risks and uncertainties that may materially impact the achievement of the outlook.
These require that we provide an assessment of the probability and impact of certain risks and uncertainties that could materially affect our outlook. A summary of such risk assessment is set forth below.
These require that we provide an assessment of the probability and impact of certain risks and uncertainties that could materially affect our outlook.
In addition, not all funds depicted by adjusted EBITDA are available for management’s discretionary use. For example, a substantial portion of such funds are subject to contractual restrictions and functional requirements to fund debt service, capital expenditures and other commitments from time to time as described in more detail elsewhere in this report.
For example, a substantial portion of such funds are subject to contractual restrictions and functional requirements to fund debt service, capital expenditures, and other commitments as described in more detail elsewhere in this report.
The dividend payment in May 2025, anticipated capital expenditures and, to a lesser extent, exercises of put options as well as further acquisition payments are expected to be covered by our cash flow, including the use of existing credit facilities and, if required, additional debt financing.
The dividend payment in May 2026, anticipated capital expenditures as well as further acquisition payments are expected to be covered by our cash flow, including the use of existing credit facilities and, if required, additional debt financing. We have sufficient flexibility to meet our financing needs in 2026. V.
Organic growth was supported by value and risk-based care programs, reimbursement rate increases and a favorable payor mix, partially offset by increased implicit price concessions.
Organic growth was supported by reimbursement rate increases and a favorable payor mix, which were offset by increased implicit price concessions.
For the year ended December 31, 2024, approximately 18% of our consolidated revenue was attributable to U.S. federally-funded health care benefit programs, such as Medicare and Medicaid reimbursement, under which reimbursement rates are set by CMS. Legislative changes could affect reimbursement rates for a significant portion of the services we provide.
Significant U.S. reimbursement, legislative matters, and other Medicare payment arrangements A significant portion of healthcare services we provide is paid for by governmental institutions. For the year ended December 31, 2025, approximately 16% of our consolidated revenue was attributable to U.S. federally-funded healthcare benefit programs, such as Medicare and Medicaid, under which reimbursement rates are set by CMS.
Capital expenditures accounted for approximately 4% and 3% of total revenue in 2024 and 2023, respectively. Investments in 2024 were primarily comprised of purchases of debt securities and equity investments.
Capital expenditures accounted for approximately 5%, 4%, and 3% of total revenue in 2025, 2024, and 2023, respectively. Acquisitions in 2025 relate primarily to the purchase of clinics and centers. Investments in 2025 were primarily comprised of purchases of debt securities.
Company structure For a description of our structure, especially as it relates to our operating segments, see “Certain defined terms,” above, as well as note 29 of the notes to the consolidated financial statements included in this report. Significant U.S. reimbursement matters The majority of health care services we provide are paid for by governmental institutions.
Company structure For a description of our structure, especially as it relates to our operating segments, see “Certain defined terms,” above, as well as note 29 of the notes to the consolidated financial statements included in this report.
Care Enablement For the year ended December 31, 2024, Care Enablement recorded operating income as compared to an operating loss for the year ended December 31, 2023, primarily due to a favorable impact from business growth (driven by positive volume and pricing developments which were partially offset by volume-based procurement in China), a favorable impact from Legacy Portfolio Optimization, net savings from the FME25 Program and a positive impact from the remeasurement of receivables related to a royalty stream that we are entitled to base on sales made by Humacyte, Inc. in the U.S., partially offset by inflationary cost increases and unfavorable foreign currency transaction effects.
Care Enablement For the year ended December 31, 2024, Care Enablement recorded operating income as compared to an operating loss for the year ended December 31, 2023, primarily due to a favorable impact from business growth (driven by positive volume and pricing developments which were partially offset by volume-based procurement in China), a favorable impact from Legacy Portfolio Optimization, net savings from the FME25+ Program, and a positive impact from the remeasurement of receivables related to a royalty stream that we are entitled to base on sales made by Humacyte, Inc. in the U.S., partially offset by inflationary cost increases and unfavorable foreign currency transaction effects. 85 Table of Contents Secondary performance indicators and other contributors to profit and loss Costs of revenue remained relatively stable as compared to the year ended December 31, 2023 as increased value and risk-based care program expenses (contract expansion and membership growth) in Value-Based Care, higher personnel expense in Care Delivery and inflationary cost increases were mostly offset by lower costs associated with business growth in Care Delivery (partially offset by higher costs in Care Enablement), the absence, in 2024, of the results of operations for businesses previously divested under Legacy Portfolio Optimization primarily within Care Delivery, net savings from the FME25+ Program and a positive impact from foreign currency translation.
With our R&D activities, we aim to develop innovative products and therapies that not only meet high quality standards and improve clinical outcomes, but are also affordable.
With the R&D activities, Fresenius Medical Care therefore aims to develop innovative products and therapies that not only meet high quality standards and improve clinical outcomes but are also cost efficient.
We could be subject to fines and other financial burdens associated with global environmental, social and governance regulations, laws and activities, and we could alienate our patients, employees, customers, partners, investors and the communities we serve.
We could be subject to fines and other financial burdens associated with global environmental, social and governance regulations, laws and activities, and we could alienate our patients, employees, customers, partners, investors, and the communities we serve. Furthermore, if we do not meet investors’ or certain markets’ ESG standards, the market for our securities could be adversely impacted.
Accounts receivable balances, net of expected credit losses, represented Days Sales Outstanding (DSO) (Non-IFRS Measure) of 63 days at December 31, 2024, a decrease as compared to 67 days at December 31, 2023. 98 Table of Contents DSO by segment is calculated by dividing the respective segment’s trade accounts and other receivables from unrelated parties (including receivables related to assets held for sale) less contract liabilities, converted to euro using the average exchange rate for the period presented by the average daily sales for the last twelve months of that segment, including sales or value-added tax, converted to euro using the average exchange rate for the period.
DSO by segment is calculated by dividing the respective segment’s trade accounts and other receivables from unrelated parties (including receivables related to assets held for sale) less contract liabilities, converted to euro using the average exchange rate for the period presented by the average daily sales for the last twelve months of that segment, including sales or value-added tax, converted to euro using the average exchange rate for the period.
For information regarding other contractual commitments, see note 25 of the notes to the consolidated financial statements included in this report.
For additional information regarding other operating income and expense, see note 5 e) of the notes to the consolidated financial statements included in this report.
Although current and future economic conditions could adversely affect our business and our profitability, we believe that we are well positioned to continue to operate our business while meeting our financial obligations as they come due, and to resume growing our business as macroeconomic conditions improve and headwinds subside.
For information regarding other contractual commitments, see note 25 of the notes to the consolidated financial statements included in this report. 93 Table of Contents Although current and future economic conditions could adversely affect our business and our profitability, we believe that we are well positioned to continue to operate our business while meeting our financial obligations as they come due, and to resume growing our business as macroeconomic conditions improve and headwinds subside.
The decrease in net income attributable to noncontrolling interests was primarily due to lower earnings in fully consolidated entities in which we have less than 100% ownership, partially offset by a favorable impact from Legacy Portfolio Optimization.
For information regarding the impact of Pillar Two tax legislation, see note 5 g) of the notes to the consolidated financial statements included in this report. 86 Table of Contents The decrease in net income attributable to noncontrolling interests was primarily due to lower earnings in fully consolidated entities in which we have less than 100% ownership, partially offset by a favorable impact from Legacy Portfolio Optimization.

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Biggest changeThe annual target values and target achievement are shown in the following table: Long-Term Incentive Target values and target achievement for the Allocation 2021 under the MB LTIP 2020 Target values Actual values Target achievement At Constant Currency Currency Per As translation according to performance 0% 100% 200% reported adjustment plan terms target Annual 2021 Revenue growth 1 % = 6 % 11 % (1.3) % 3.1 % 1.8 % 16 % Net income growth 0 % = 5 % 10 % (16.8) % 2.4 % (14.4) % 0 % 5 % Return on invested capital (ROIC) 5.5 % = 6.0 % 6.5 % 4.9 % % 4.9 % 0 % 2022 Revenue growth 1 % = 6 % 11 % 10.1 % (8.0) % 2.1 % 22 % Net income growth 0 % = 5 % 10 % (30.5) % (6.1) % (36.6) % 0 % 7 % Return on invested capital (ROIC) 5.5 % = 6.0 % 6.5 % 3.3 % % 3.3 % 0 % 2023 Revenue growth 1 % = 6 % 11 % 0.3 % 5.2 % 5.5 % 90 % Net income growth 0 % = 5 % 10 % (25.9) % 1.6 % (24.3) % 0 % 30 % Return on invested capital (ROIC) 5.5 % = 6.0 % 6.5 % 2.8 % % 2.8 % 0 % Overall Target Achievement 14 % 132 Table of Contents Vested amounts (Allocation 2021) The following table shows the amounts that vested in the Fiscal Year from the Allocation 2021 and were awarded within the meaning of Section 162 paragraph 1 sentence 1 AktG: Long-Term Incentive Vested amount from the Allocation 2021 of the MB LTIP 2020 Number of allocated Number of final Fair Value at Performance Overall target Performance Share price at allocation Shares achievement Shares vesting Vested amount in THOUS in % in in THOUS Members of the Management Board in office in the Fiscal Year Helen Giza (1) 1,138 20,941 14 2,932 36.79 121 Franklin W.
Biggest changeFor a description of ROIC and how the measure is calculated, see Item 5, “Operating and financial review and prospects,” above. 124 Table of Contents Vested amounts (Allocation 2022) The following table shows the amounts that vested in the fiscal year 2025 from the allocation for 2022 and were awarded within the meaning of Section 162(1), first sentence AktG: Long-term incentive Vested amount from the Allocation 2022 of the MB LTIP 2020 Number of allocated Number of final Fair Value at Performance Overall target Performance Share price at allocation Shares achievement Shares vesting Vested amount in K in % in in K Members of the Management Board in office in the fiscal year Helen Giza (1) 1,688 32,279 6 1,936 46.04 97 Franklin W.
In accordance with recommendation G.10 of the German Corporate Governance Code (GCGC), the members of the Management Board therefore cannot dispose of the corresponding amounts before four years have passed since the respective allocation.
In accordance with recommendation G.10 of the German Corporate Governance Code (GCGC), the Management Board members therefore cannot dispose of the corresponding amounts before four years have passed since the respective allocation.
Also, the Supervisory Board has adopted a policy that in accordance with applicable regulatory requirements provides that the Company may recover excess incentive-based compensation if it is required to prepare an accounting restatement due to material noncompliance with relevant financial reporting requirements under U.S. federal securities laws.
Also, the Supervisory Board has adopted a policy that in accordance with applicable U.S. regulatory requirements provides that the Company may recover excess incentive-based compensation if it is required to prepare an accounting restatement due to material noncompliance with relevant financial reporting requirements under U.S. federal securities laws.
Based on the degree of the overall target achievement, the number of Performance Shares to vest is determined for each member of the Management Board. The number of Performance Shares may increase or decrease over the performance period.
Based on the degree of the overall target achievement, the number of Performance Shares to vest is determined for each Management Board member. The number of Performance Shares may increase or decrease over the performance period.
The defined benefit pension commitments each provide for a retirement pension and survivor benefits ( Hinterbliebenenversorgung ) as of the time of conclusively ending active work (at age 65 at the earliest) or upon occurrence of disability or incapacity to work ( Berufs- oder Erwerbsunfähigkeit ) or of a full or partial reduction in earning capacity ( Erwerbsminderung ), calculated by reference to the amount of the recipient’s most recent base salary.
The defined benefit pension commitments each provide for a retirement pension and survivor benefits (Hinterbliebenenversorgung) as of the time of conclusively ending active work (at age 65 at the earliest) or upon occurrence of disability or incapacity to work (Berufs- oder Erwerbsunfähigkeit) or of a full or partial reduction in earning capacity (Erwerbsminderung), calculated by reference to the amount of the most recent base salary.
Ropertz u. Dr. Jennessen. Mr. Prescher trained as a registered nurse at Franziskus Hospital in Mönchengladbach, Germany. DR. MANUELA STAUSS-GRABO became a member of the Supervisory Board on January 26, 2024. Dr. Stauss-Grabo has been Senior Vice President and Head of Clinical Research in the Global Medical Office of the Company since 2024. From 2015 to 2024, Dr.
Ropertz u. Dr. Jennessen. Mr. Prescher trained as a registered nurse at Franziskus Hospital in Mönchengladbach, Germany. DR. MANUELA STAUSS-GRABO became a member of the Supervisory Board on January 26, 2024. Dr. Stauss-Grabo has been Senior Vice President and Head of Global Clinical Research in the Global Medical Office of the Company since 2023. From 2015 to 2023, Dr.
Benefits from third parties Unless otherwise stated in this Compensation Report, no benefits were awarded or promised to the members of the Management Board by a third party in the Fiscal Year with regard to their activities as members of the Management Board, and compensation awarded to members of the Management Board for management activities or supervisory board mandates in companies of the Company’s group is offset against the compensation of the respective member of the Management Board.
Benefits from third parties Unless otherwise stated in this Compensation Report, no benefits were awarded or promised to the Management Board members by a third party in the fiscal year with regard to their activities as Management Board members, and compensation awarded to Management Board members for management activities or supervisory board mandates in Group companies is offset against the compensation of the respective Management Board member.
In order to determine the number of Performance Shares to be allocated to the relevant Management Board member, the relevant allocation amount was divided by the value per Performance Share determined in accordance with IFRS 2 and considering the average price of the Company’s shares over a period of 30 calendar days prior to each relevant allocation date.
To determine the number of Performance Shares to be allocated to the relevant Management Board member, the relevant allocation amount was divided by the value per Performance Share determined in accordance with IFRS 2 and considering the average price of the Company’s shares over a period of 30 calendar days prior to each relevant allocation date.
With respect to the amount paid in Germany, it was agreed with the aforementioned Management Board members that due to varying tax rates in both countries, the increased or lower tax burden to such members of the Management Board arising from German tax rates in comparison to U.S. tax rates will be balanced or will be paid back by them (net compensation).
With respect to the amount paid in Germany, it was agreed with the aforementioned Management Board members that, due to varying tax rates in both countries, the increased or lower tax burden to such Management Board members arising from German tax rates in comparison to U.S. tax rates will be balanced or will be paid back by them (net compensation).
After the final determination of the overall target achievement, the number of Performance Shares to vest is multiplied by the average price of the Company’s shares over the 30 calendar days preceding the relevant vesting date in order to calculate the corresponding amount received from the Performance Shares to vest.
After the determination of the overall target achievement, the number of Performance Shares to vest is multiplied by the average price of the Company’s shares over the 30 calendar days preceding the relevant vesting date in order to calculate the corresponding amount received from the Performance Shares to vest.
The amount of the base salary is set out in the individual service agreements of the members of the Management Board. In line with standard local practice, the base salary is generally paid in twelve monthly installments for members of the Management Board resident in Germany and in biweekly installments for members of the Management Board resident in the U.S.
The amount of the base salary is set out in the service agreements of the Management Board members. In line with standard local practice, the base salary is generally paid in twelve monthly installments for Management Board members resident in Germany and in biweekly installments for Management Board members resident in the U.S.
Prescher, who are employee representatives, see Item 16D, “Exemptions from the listing standards for audit committees.” The primary function of the Audit Committee is to assist FME AG’s Supervisory Board in fulfilling its oversight responsibilities, primarily through: overseeing FME AG’s accounting and financial reporting processes, the performance of the internal audit function and the effectiveness of the internal control system; overseeing the auditing of FME AG’s financial statements; overseeing FME AG’s sustainability related objectives and the auditing or assurance of the Company’s sustainability reporting required by law; overseeing the independence and performance of FME AG’s outside auditors; overseeing the effectiveness of our risk management system; overseeing the effectiveness of our systems and processes utilized to comply with relevant legal and regulatory standards for global health care companies; overseeing our relationship with Fresenius SE and its affiliates as well as overseeing related party transactions generally; reporting by FME AG’s outside auditors directly to the Audit Committee; and performing such other functions and exercising such other responsibilities as are required to be performed or exercised by audit committees by applicable law or as may be delegated to the Audit Committee by the Supervisory Board.
Prescher, who are employee representatives, see Item 16D, “Exemptions from the listing standards for audit committees.” The primary function of the Audit Committee is to assist FME AG’s Supervisory Board in fulfilling its oversight responsibilities, primarily through: overseeing FME AG’s accounting and financial reporting processes, the performance of the internal audit function and the effectiveness of the internal control system; overseeing the auditing of FME AG’s financial statements; overseeing FME AG’s sustainability related objectives and the auditing or assurance of the Company’s sustainability reporting required by law; overseeing the independence and performance of FME AG’s outside auditors; overseeing the effectiveness of our risk management system; overseeing the effectiveness of our systems and processes utilized to comply with relevant legal and regulatory standards for global healthcare companies; overseeing our relationship with Fresenius SE and its affiliates as well as overseeing related party transactions generally; reporting by FME AG’s outside auditors directly to the Audit Committee; and performing such other functions and exercising such other responsibilities as are required to be performed or exercised by audit committees by applicable law or as may be delegated to the Audit Committee by the Supervisory Board.
The investment obligation under the SOG may be satisfied by acquisition of shares or American Depositary Shares (ADSs). For simplification purposes, the number of shares and ADSs have been combined in the following table.
The investment obligation under the SOG may be satisfied by acquisition of shares or American Depositary Shares (ADSs) representing shares. For simplification purposes, the number of shares and ADSs have been combined in the following table.
Horizontal comparison (peer group) In order to assess the appropriateness of the Compensation System 2024+ and the individual compensation of the Management Board members, the Supervisory Board conducts a horizontal review of compensation amounts and structures (external comparison).
Horizontal comparison (peer group) In order to assess the appropriateness of the Compensation System 2024+ and the individual compensation of the Management Board members, the Supervisory Board conducts a horizontal review of the respective compensation amounts and structures (external comparison).
The maximum compensation limits the benefits that a member of the Management Board can receive as compensation for a fiscal year, irrespective of when the actual payment accrues.
This maximum compensation limits the benefits that a Management Board member can receive as compensation for a fiscal year, irrespective of when the actual payment accrues.
Kuhnert is a member of the Board of Directors of Döhler Group SE, a global producer and provider of technology-based ingredients and ingredient systems for the food and beverage industries based in Darmstadt, Germany. He is also a member of the supervisory board of MEWA Textil-Service SE, Germany, and maxingvest GmbH & Co. KGaA, Germany. 111 Table of Contents MR.
Kuhnert is a member of the Board of Directors of Döhler Group SE, a global producer and provider of technology-based ingredients and ingredient systems for the food and beverage industries based in Darmstadt, Germany. He is also a member of the supervisory board of MEWA Textil-Service SE, Germany, and maxingvest GmbH & Co. KGaA, Germany. 105 Table of Contents MR.
See Item 16G, “Corporate Governance.” Instead, as a German publicly-held company, we prepare a Compensation Report in accordance with the requirements of the German statutory provisions referred to below. Set forth below is a convenience translation of the Compensation Report of FME AG for the fiscal year 2024, substantially in its entirety.
See Item 16G, “Corporate Governance.” Instead, as a German publicly-held company, we prepare a Compensation Report in accordance with the requirements of the German statutory provisions referred to below. Set forth below is a convenience translation of the Compensation Report of FME AG for the fiscal year 2025, substantially in its entirety.
The target achievement of the Relative TSR is determined based on the percentile ranking of the TSR performance of the Company in comparison to the TSR performance of companies in one or more comparison groups determined by the Supervisory Board. In general, STOXX® Europe 600 Health Care and S&P 500 Health Care indices are determined as comparison groups.
The target achievement of the Relative TSR is determined based on the percentile ranking of the Company’s TSR performance in comparison to the TSR performance of companies in one or more comparison groups determined by the Supervisory Board. In general, STOXX® Europe 600 Health Care and S&P 500 Health Care indices are determined as comparison groups.
Furthermore, the compensation for the members of the Supervisory Board and its committees was changed with effect as of July 1, 2024 and increased moderately overall in order to appropriately take into account the further increased demands regarding the responsibilities of the Supervisory Board and certain Supervisory Board committees as well as the corresponding increase in time expenditure.
Compensation of the Supervisory Board The compensation for the members of the Supervisory Board and its committees was changed with effect as of July 1, 2024, and increased moderately overall to appropriately take into account the further increased demands regarding the responsibilities of the Supervisory Board and certain Supervisory Board committees as well as the corresponding increase in time expenditure.
The total proceeds from the Performance Shares (the amount that can be earned under an allocation) are capped at 400% of the relevant allocation amount. The proceeds from the Performance Shares (after taxes and duties) are transferred to a bank, which uses them to purchase shares of the Company on the stock exchange.
The total proceeds from the Performance Shares (i.e., the amount that can be earned under an allocation) are capped at 400% of the relevant allocation amount. The proceeds from the Performance Shares (after taxes and duties) are transferred to a bank, which uses them to purchase shares of the Company on the stock exchange.
Hennicken had been a member of the supervisory board of Management AG since September 1, 2022). She is also a member of the supervisory board of Fresenius Kabi AG since September 1, 2022 and, after having served as its Chair, became its Deputy Chair on March 8, 2023. Ms.
Hennicken had been a member of the supervisory board of Management AG since September 1, 2022). She is also a member of the supervisory board of Fresenius Kabi AG since September 1, 2022 and, after having served as its Chair, became its Deputy Chair on March 8, 2023. Since December 14, 2022, Ms.
Shervin J. Korangy (Deputy Chair), Ms. Sara Hennicken and Ms. Pascale Witz. The Nomination Committee recommends suitable candidates to the Supervisory Board for its proposals to the General Meeting for the election of Supervisory Board members or, if required, for judicial appointment of shareholder representatives on the Supervisory Board.
Korangy (Deputy Chair), Ms. Sara Hennicken, and Ms. Pascale Witz. The Nomination Committee recommends suitable candidates to the Supervisory Board for its proposals to the General Meeting for the election of Supervisory Board members or, if required, for judicial appointment of shareholder representatives on the Supervisory Board.
Continued compensation in cases of sickness All Management Board members have received individual contractual commitments to obtain continued compensation in cases of sickness for a maximum of twelve months; after six months of sick leave, insurance benefits may be offset against such payments.
Continued compensation in cases of sickness The Management Board members have received individual contractual commitments to obtain continued compensation in cases of sickness for a maximum of twelve months; after six months of sick leave, insurance benefits may be offset against such payments.
The Compensation Report includes individualized and comprehensive information on the compensation within the meaning of Section 162 paragraph 1 AktG awarded and due to current and former members of the management board and of the supervisory board in the Fiscal Year and benefits within the meaning of Section 162 paragraph 2 AktG awarded or promised to members of the management board.
The Compensation Report includes individualized and comprehensive information on compensation within the meaning of Section 162(1) AktG awarded or due to current and former members of the Company’s Management Board and Supervisory Board in the fiscal year and on benefits within the meaning of Section 162(2) AktG awarded or promised to Management Board members.
If such covenant becomes applicable, the member of the Management Board will receive, for a period of up to two years, non-compete compensation amounting to half of the respective annual base salary for each year the non-competition covenant is applied.
If such clause becomes applicable, the Management Board member will receive, for a period of up to two years, non-compete compensation amounting to half of the respective annual base salary for each year the non-competition clause is applied.
As of December 31, 2024, there were no outstanding balances of erroneously awarded incentive-based compensation to be recovered from the application of the policy to a prior restatement. Our Incentive-based Compensation Recover Policy is included as Exhibit 97 to this Report.
As of December 31, 2025, there were no outstanding balances of erroneously awarded incentive-based compensation to be recovered from the application of the policy to a prior restatement. Our Incentive-based Compensation Recover Policy is included as Exhibit 97 to this Report.
(2) Member of the Nomination Committee. (3) Member of the Compensation Committee. 110 Table of Contents (4) Member of the Audit Committee. (5) Member of the Mediation Committee. For information regarding the Supervisory Board committees, see “Board Practices,” below. Shareholder representatives MR.
(2) Member of the Nomination Committee. (3) Member of the Compensation Committee. (4) Member of the Audit Committee. (5) Member of the Mediation Committee. 104 Table of Contents For information regarding the Supervisory Board committees, see “Board Practices,” below. Shareholder representatives MR.
This means that more than one tranche of the Long-Term Incentives could be earned in certain years and is therefore deemed to have been awarded. This applies, for example, to the 2019 allocation under the Management Board Long Term Incentive Plan 2019 (MB LTIP 2019) and the 2020 allocation under the MB LTIP 2020, which each vested in 2023.
This means that more than one LTI tranche could be earned in certain years and is therefore deemed to have been awarded. This applies, for example, to the 2019 allocation under the Management Board Long-Term Incentive Plan 2019 (MB LTIP 2019) and the 2020 allocation under the MB LTIP 2020, which each vested in 2023.
Sorensen holds an M.D. degree from Harvard Medical School, an MS in Computer Science from Brigham Young University and a BS in Biology from the California Institute of Technology. Since August 2023, Mr. Sorensen is a member of the Board of Directors and the Chief Science Officer of RadNet, Inc. Mr. Sorensen has been President of DeepHealth, Inc.
Sorensen holds an MD degree from Harvard Medical School, an MS in Computer Science from Brigham Young University and a BS in Biology from the California Institute of Technology. Since August 2023, Mr. Sorensen is a member of the Board of Directors and the Chief Science Officer of RadNet, Inc. Mr. Sorensen has been President of DeepHealth, Inc.
Information on the target values and the respective performance target achievement will be disclosed after the end of the performance period in the Compensation Report for the relevant fiscal year. 149 Table of Contents C.
Information on the target values and the respective performance target achievement will be disclosed after the end of the performance period in the Compensation Report for the relevant fiscal year. 140 Table of Contents C.
Sen was a member of the Management Board of Siemens AG, where he was responsible for the health care business Siemens Healthineers and for Siemens’ energy business. Prior to that, he was Chief Financial Officer of E.ON SE. At the start of his professional career, Mr.
Sen was a member of the Management Board of Siemens AG, where he was responsible for the healthcare business Siemens Healthineers and for Siemens’ energy business. Prior to that, he was Chief Financial Officer of E.ON SE. At the start of his professional career, Mr.
Therefore, the compensation of the members of the Management Board made a significant contribution to promoting the business strategy and the long-term sustainable development of the Company and the group. Business performance and economic environment See Item 5, “Operating and financial review and prospects,” above.
Consequently, the compensation of the Management Board members made a significant contribution to promoting the Company’s business strategy and the long-term sustainable development of the Company and the Group. Business performance and economic environment See Item 5, “Operating and financial review and prospects,” above.
However, all orphans’ pensions and the surviving spouse’s pension, taken together, may not exceed 90% of the Management Board member’s pension claim. 142 Table of Contents If the Management Board member leaves the Management Board before reaching the age of 65, the rights to the aforementioned benefits survive.
However, all orphans’ pensions and the surviving spouse’s pension, taken together, may not exceed 90% of the Management Board member’s pension claim. If the Management Board member leaves the Management Board before reaching the age of 65, the rights to the aforementioned benefits survive.
At the same time, it provided effective incentives for the long-term value-creation of the Company taking into account the interests of patients, shareholders, employees and other stakeholders as well as compensation practices in relevant comparable markets.
At the same time, the compensation provided effective incentives for the Company’s long-term value creation taking into account the interests of patients, shareholders, employees and other stakeholders as well as compensation practices in relevant comparable markets.
The number of Performance Shares to vest for each Management Board member depended on the achievement of the performance targets. 130 Table of Contents Functioning The functioning of the MB LTIP 2020 is shown in the following diagram: The Supervisory Board defined for each performance target the specific target values that lead to a target achievement of 0% (lower threshold), 100% and 200% (cap).
The number of Performance Shares to vest for each Management Board member depended on the achievement of the performance targets. 122 Table of Contents Functioning The functioning of the MB LTIP 2020 is shown in the following chart: The Supervisory Board defined for each performance target the specific target values that lead to a target achievement of 0% (lower threshold), 100% and 200% (cap).
Link to strategy The three performance targets revenue growth, net income growth and return on invested capital (ROIC) were selected because they provide effective incentives that the Company’s investments achieve a certain return and thus promote long-term, profitable growth and an attractive total return for shareholders.
Link to strategy The three performance targets revenue growth, net income growth and return on invested capital (ROIC) were selected because they provide effective incentives that the Company’s investments achieve a certain return, thereby supporting long-term, profitable growth and an attractive total return for shareholders.
In the Fiscal Year, there was no reason for the Supervisory Board to make use of this cap option. 123 Table of Contents In addition, there is a maximum amount of total compensation for each member of the Management Board (maximum compensation).
In the fiscal year, there was no reason for the Supervisory Board to make use of this cap option. In addition, there is a maximum amount of total compensation for each Management Board member (maximum compensation).
Changes in the value of the shares after their acquisition are not taken into account for purposes of the fulfillment of the investment obligation under the SOG. 140 Table of Contents The shareholdings notified to the Company as of the end of the Fiscal Year of the members of the Management Board in office in the Fiscal Year as well as the status of the fulfillment of the SOG are shown in the following table.
Changes in the value of the shares after acquisition are not taken into account for purposes of the fulfillment of the investment obligation under the SOG. 132 Table of Contents The shareholdings notified to the Company as of the end of the fiscal year of the Management Board members as well as the status of the fulfillment of the SOG are shown in the following table.
The allocation amount for the Performance Shares equaled 135% (multiplier of 1.35) of the relevant base salary of the respective Management Board member.
The allocation amount for the Performance Shares equals 135% (multiplier of 1.35) of the relevant base salary of the respective Management Board member.
Changes to the remuneration in the Fiscal Year The Company’s 2024 AGM resolved with a majority of around 99.49% of the votes cast to amend the corresponding provisions of the Articles of Association with effect from July 1, 2024.
Changes to the remuneration in previous year The Company’s 2024 AGM resolved with a majority of 99.49% of the votes cast to amend the corresponding provisions of the Articles of Association with effect from July 1, 2024.
Disclosure of a registrant’s action to recover erroneously awarded compensation During 2024, we did not have an accounting restatement that required recovery of erroneously awarded incentive-based compensation pursuant to our incentive-based compensation recovery policy.
F. Disclosure of a registrant’s action to recover erroneously awarded compensation During 2025, we did not have an accounting restatement that required recovery of erroneously awarded incentive-based compensation pursuant to our incentive-based compensation recovery policy.
In compliance with the requirements of the German Stock Corporation Act and the recommendations of the GCGC, it is ensured that compensation is commensurate with the duties and performance of each Management Board member and the Company’s situation, is geared toward the long-term, sustainable development of Fresenius Medical Care and does not exceed customary compensation without any special justification.
The Supervisory Board in compliance with the requirements of the German Stock Corporation Act and the recommendations of the GCGC also ensures that the compensation is commensurate with the duties and performance of each Management Board member and the Company’s situation, is geared toward the long-term, sustainable development of Fresenius Medical Care, and does not exceed customary compensation without any special justification.
Share ownership As of December 31, 2024, no member of our Supervisory Board or our Management Board beneficially owned 1% or more of our outstanding shares, according to the most recent information available.
Share ownership As of December 31, 2025, no member of our Supervisory Board or our Management Board beneficially owned 1% or more of our shares, according to the most recent information available.
The shares acquired in this way are subject to a holding period of at least one year. In accordance with recommendation G.10 of the GCGC, the members of the Management Board can therefore only dispose of this Long-Term Incentive after a period of at least four years.
The shares acquired in this way are subject to a holding period of at least one year. In accordance with recommendation G.10 of the GCGC, the Management Board members can therefore only dispose of the LTI after a period of at least four years.
As a result, compensation awarded or due to Management Board members is usually lower in the first years of their Management Board activity than in subsequent years. The vesting periods for the various Long-Term Incentives included in the following table are not identical.
As a result, compensation awarded or due to Management Board members is usually lower in the first years of their Management Board activity than in subsequent years. The vesting periods for the various LTIs included in the following table are not identical.
The target achievement for the sustainability target and the individual, equally weighted sustainability sub-targets are shown in the following table: Short-Term Incentive Sustainability target achievement in the Fiscal Year in % Target achievement per sustainability sub-target Sustainability target achievement Patient Satisfaction (50%) Employee Satisfaction (50%) 120.00 100.00 110.00 Overall target achievement The degree of the overall target achievement for the Short-Term Incentive is determined based on the weighted arithmetic mean of the target achievement level of each performance target.
The target achievement for the sustainability target and the individual, equally weighted sustainability sub-targets are shown in the following table: Short-term incentive Sustainability target achievement in the fiscal year in % Target achievement per sustainability sub-target Sustainability target achievement Patient Satisfaction (50%) Employee Satisfaction (50%) 120.00 110.00 115.00 121 Table of Contents Overall target achievement The degree of the overall target achievement for the STI is determined based on the weighted arithmetic mean of the target achievement level of each performance target.
GREGORY SORENSEN, M.D., became a member of the Supervisory Board of the Company on May 20, 2021. Until effectiveness of the Conversion, he was also a member of the supervisory board of Management AG since May 2021. Mr.
GREGORY SORENSEN, MD, became a member of the Supervisory Board of the Company on May 20, 2021. Until effectiveness of the Conversion, he was also a member of the supervisory board of Management AG since May 2021. Mr.
This generally applies accordingly if members of the Supervisory Board hold their office in the Supervisory Board or in a committee of the Supervisory Board or hold the office as chairperson or deputy chairperson only during a part of a full fiscal year.
This in general applies accordingly if members of the Supervisory Board hold their office in the Supervisory Board or in a committee of the Supervisory Board or hold the office as Chairperson or Deputy Chairperson only during a part of a fiscal year.
The retirement pension in principle amounts to 30% of the pensionable income. The aforementioned percentage increases by 1.5 percentage points for each full year of service, up to a maximum of 45%. The pensionable income is determined on the basis of the average base salary in the last five years before the occurrence of the insured event.
The retirement pension in general amounts to 30% of the pensionable income. The percentage increases by 1.5 percentage points for each full year of service, up to a maximum of 45%. The pensionable income is determined based on the average base salary in the last five years before the occurrence of the insured event.
The following applies to each performance target: If the lower threshold of a target value is not exceeded, the target achievement is 0%. If the upper target value is reached or exceeded, the target achievement is 150%. Target achievement in the range between two adjacent target values is generally determined by linear interpolation.
The following applies to each performance target: If the lower target value is not exceeded, a target achievement of 0% applies. If the upper target value is reached or exceeded, a target achievement of 200% applies. Target achievement in the range between two adjacent target values is determined by linear interpolation.
Stauss-Grabo obtained a diploma in Biology from Julius-Maximilians University in Wuerzburg, Germany, and a Ph.D. in Pharmacy from Phillips-University in Marburg, Germany. 112 Table of Contents Management Board Each member of the Management Board is appointed by the Supervisory Board for a maximum term of five years and is eligible for reappointment thereafter.
Stauss-Grabo obtained a diploma in Biology from Julius-Maximilians University in Wuerzburg, Germany, and a PhD in Pharmacy from Phillips-University in Marburg, Germany. 106 Table of Contents Management Board Each member of the Management Board is appointed by the Supervisory Board for a maximum term of five years and is eligible for reappointment thereafter.
The aforementioned amounts in euro for the maximum compensation are identical to those under the Compensation System 2020+.
The aforementioned amounts in euros for the maximum compensation are identical to those under the Compensation System 2020+.
In the Fiscal Year, the fringe benefits awarded or due to the Management Board members under their individual service agreements consisted mainly of the private use of company cars, the payment of a mobility allowance or the use of rental cars, housing, rent and relocation payments, reimbursement of fees for the preparation of tax returns, reimbursement of charges, contributions to pension schemes (other than the pension commitments or the cash pension allowance set out herein), contributions to accident, life and health insurances or other insurances as well as tax equalization compensation due to varying tax rates applicable in Germany and the country in which the relevant Management Board member is personally taxable.
In the fiscal year, the fringe benefits consisted mainly of the private use of company cars, the payment of a mobility allowance or the use of rental cars, housing and rent payments, reimbursement of fees for the preparation of tax returns, contributions to pension schemes (other than the pension commitments or the cash pension allowance set out herein), contributions to accident, life and health insurances or other insurances as well as tax equalization compensation due to varying tax rates applicable in Germany and the country in which the relevant Management Board member is personally taxable.
Katarzyna Mazur-Hofsäß 1,064 1.35 1,436 31.54 45,542 5,744 (1) The value per Performance Share as set out herein and relevant for the number of Performance Shares to be allocated is determined according to the plan terms considering the average price of the Company’s shares over a period of 30 calendar days prior to the allocation date and assuming a 100% target achievement for the performance target “Relative TSR”, which is why it may deviate from the Fair Value according to IFRS 2.
Katarzyna Mazur-Hofsäß (4) 1,064 1.35 1,436 39.20 36,643 5,744 (1) The value per Performance Share as set out herein and relevant for the number of Performance Shares to be allocated is determined according to the plan terms considering the average price of the Company’s shares over a period of 30 calendar days prior to the allocation date and assuming a 100% target achievement for the performance target “Relative TSR”, which is why it may deviate from the Fair Value according to IFRS 2.
Manuela Stauss-Grabo 187 n.a. n.a. n.a. n.a. Pascale Witz 299 30 230 10 209 12 187 24 151 Outlook for the compensation for 2025 The Supervisory Board has again set the two equally weighted sub-targets “patient satisfaction” and “employee satisfaction” as the sustainability target for the STI for 2025 and the reduction in market-based CO 2 e emissions as the sustainability target for the LTI allocation for 2025.
Manuela Stauss-Grabo 210 12 187 n.a. n.a. n.a. Pascale Witz 290 (3) 299 30 230 10 209 12 187 Compensation outlook for 2026 The Supervisory Board has again set the two equally weighted sub-targets “Patient Satisfaction” and “Employee Satisfaction” as the sustainability target for the STI for 2026 and the reduction in market-based CO 2 e emissions as the sustainability target for the LTI allocation for 2026.
The Short-Term Incentive rewards the Management Board members for the Company’s performance in the relevant fiscal year. The Short-Term Incentive is linked to the achievement of three financial targets and one non-financial, sustainability-related performance target.
The STI rewards the Management Board members for the Company’s performance in the relevant fiscal year. The STI is linked to the achievement of three financial targets and one non-financial, sustainability-related performance target.
We are exempt from the NYSE rule requiring companies listed on that exchange to maintain compensation committees and nominating committees consisting of independent directors. See Item 16G, “Corporate governance.” D. Employees At December 31, 2024, we had 111,513 employees (total headcount) as compared to 119,845 at December 31, 2023, and 128,044 at December 31, 2022.
We are exempt from the NYSE rule requiring companies listed on that exchange to maintain compensation committees and nominating committees consisting solely of independent directors. See Item 16G, “Corporate governance.” D. Employees At December 31, 2025, we had 109,698 employees (total headcount) as compared to 111,513 at December 31, 2024 and 119,845 at December 31, 2023.
Between 2005 and 2010 she worked for Citigroup in Frankfurt and London. Ms. Hennicken studied economics in Germany and in the United States. MR. SHERVIN J. KORANGY became a member of the Supervisory Board upon effectiveness of the Conversion. Mr.
Between 2005 and 2010 she worked for Citigroup in Frankfurt and London. Ms. Hennicken studied economics in Germany and in the United States. MR. SHERVIN J. KORANGY became a member of the Supervisory Board upon effectiveness of the Conversion. Mr. Korangy became a senior advisor to TPG Inc.
BEATE HAßDENTEUFEL became a member of the Supervisory Board on January 26, 2024. Ms. Haßdenteufel has served as Chair of the representative body for the severely disabled employees at our St. Wendel facility since 2013 and Deputy Chair of the St. Wendel works council since 2012. From 2022 to 2023, Ms.
BEATE HAßDENTEUFEL became a member of the Supervisory Board on January 26, 2024. Ms. Haßdenteufel has served as Chair of the representative body for the severely disabled employees at our St. Wendel facility since 2013 and Deputy Chair of the St. Wendel works council since 2012 and has been a member of the works council since 2006. Ms.
D. in Leadership and Learning in Organizations from Peabody College at Vanderbilt University, an MHA/MBA from the University of Houston at Clear Lake and a Bachelor of Arts from The University of Texas. DR.
He holds an EdD in Leadership and Learning in Organizations from Peabody College at Vanderbilt University, an MHA/MBA from the University of Houston at Clear Lake and a Bachelor of Arts from The University of Texas. DR.
The shares must generally be acquired within four years of the start of the respective service agreement, but no earlier than January 1, 2024, and must be held for a period of at least two years after the end of the respective service agreement.
The shares must in general be acquired within four years of the start of the respective service agreement, but no earlier than January 1, 2024, (build-up period) and must be held for a period of at least two years after the end of the respective service agreement.
Based on this understanding, the Short-Term Incentive is considered to have vested in the year, and is shown in the following tables for the respective years, in which the underlying activity was performed.
Based on this understanding, the STI is considered to have vested in the year and is shown in the following tables for the respective years, in which the underlying activity was performed.
Compensation of the Management Board In accordance with the applicable plan terms, an award in the meaning of this Compensation Report from the Long-Term Incentive to the members of the Management Board is generally made only after expiry of the multi-year vesting period.
Compensation of the Management Board In accordance with the applicable plan terms, an award within the meaning of this Compensation Report from the LTI to the Management Board members is generally made only after expiry of the multi-year vesting period.
For further details see the section “Short-Term Incentive MBBP 2024+.” 115 Table of Contents Long-term incentive target achievement for the performance period ending at the end of the Fiscal Year The performance period of the allocation made in 2022 under the Management Board Long Term Incentive Plan 2020 (MB LTIP 2020) as a long-term variable compensation component (Long-Term Incentive) ended upon the end of the Fiscal Year.
For further details, see the section “Short-term incentive MBBP 2024+.” Long-term incentive target achievement for the performance period ending at the end of the fiscal year The performance period of the allocation made in 2023 under the Management Board Long-Term Incentive Plan 2020 (MB LTIP 2020) as a long-term variable compensation component (long-term incentive LTI) ended upon the end of the fiscal year 2025.
Board practices For information relating to the terms of office of the Management Board and of the Supervisory Board, and the periods in which the members of those bodies have served in office, see Item 6.A, “Directors, senior management and employees Directors and senior management,” above. The Audit Committee of the Supervisory Board currently consists of Dr.
Board practices For information relating to the terms of office of the Management Board and of the Supervisory Board, and the periods in which the members of those bodies have served in office, see Item 6.A, “Directors, senior management and employees Directors and senior management,” above. The Supervisory Board has formed an Audit Committee consisting of Dr.
The Compensation Committee also prepares the regular review by the Supervisory Board of the appropriateness of the compensation system and of the total compensation of the individual Management Board members. The Compensation Committee also reviews the annual compensation report. 150 Table of Contents The Nomination Committee of the Supervisory Board of the Company consists of Mr. Michael Sen (Chair), Mr.
The Compensation Committee also prepares the regular review by the Supervisory Board of the appropriateness of the compensation system and of the total compensation of the individual Management Board members. The Compensation Committee also reviews the annual compensation report. The Nomination Committee of the Supervisory Board of the Company consists of Mr. Michael Sen (Chair), Mr. Shervin J.
Long-Term Incentive MB LTIP 2020 On the basis of the Compensation System 2020+, Performance Shares were allocated in previous years to the Management Board members in office at the time under the MB LTIP 2020 as a performance-based Long-Term Incentive. In the Fiscal Year, the compensation from the Performance Shares allocated for 2021 was earned.
Long-term incentive MB LTIP 2020 Based on the Compensation System 2020+, Performance Shares were allocated in previous years to the Management Board members in office at the time under the MB LTIP 2020 as performance-based LTI compensation. In the fiscal year, the compensation from the Performance Shares allocated for 2022 was earned.
Witz has served on the Board of Directors of Regulus Therapeutics Inc. since June 1, 2017, Horizon Therapeutics from August 3, 2017 until October 6, 2023, and Revvity, Inc. (formerly known as Perkin Elmer Inc.) since October 30, 2017. Employee representatives MS. STEFANIE BALLING became a member of the Supervisory Board on January 26, 2024. Ms.
Witz has served on the Board of Directors of Regulus Therapeutics Inc. from June 1, 2017 until June 25, 2025 and Revvity, Inc. (formerly known as Perkin Elmer Inc.) since October 30, 2017. Employee representatives MS. STEFANIE BALLING became a member of the Supervisory Board on January 26, 2024. Ms.
When conducting the vertical review, the Supervisory Board in accordance with recommendation G.4 of the GCGC also takes into account the development of compensation levels over time.
When conducting the vertical review, the Supervisory Board in accordance with recommendation G.4 of the GCGC also considers the development of compensation levels over time.
As part of a group-wide survey, the company evaluated employee feedback on positive aspects of the working environment as well as opportunities for improvement.
As part of a group-wide survey, Fresenius Medical Care evaluated employee feedback on positive aspects of the working environment as well as opportunities for improvement.
They are also set out in this Compensation Report insofar as they are relevant to compensation awarded or due in the Fiscal Year.
These main elements are also set out in this Compensation Report insofar as they are relevant to compensation awarded or due in the fiscal year 2025.
The Compensation System 2024+ and the Compensation System 2020+ as well as the compensation awarded or due in the Fiscal Year are in each case in accordance with the relevant recommendations of the GCGC in the version dated April 28, 2022.
The compensation components awarded or due in the fiscal year are in accordance with the respective compensation systems. 111 Table of Contents The Compensation System 2024+ and the Compensation System 2020+ as well as the compensation awarded or due in the fiscal year are in each case in accordance with the relevant recommendations of the GCGC in the version dated April 28, 2022.
The Presiding Committee is responsible in particular for administrative matters relating to the Supervisory Board and for various Management Board matters including recommendations to the Supervisory Board on the appointment or dismissal of Management Board members and on the allocation of responsibilities among the Management Board members. The Presiding Committee further reviews and assesses the Company’s corporate governance.
The Presiding Committee is responsible in particular for administrative matters relating to the Supervisory Board and for various Management Board matters including recommendations to the Supervisory Board on the appointment or dismissal of Management Board members and on the allocation of responsibilities among the Management Board members.
Previously, he was a Managing Director at the Blackstone Group, one of the largest global investment firms, which he joined in 1996. During his more than 14 years at Blackstone, he served as both an advisor in the Restructuring/Special Situations business and as an investor in the Private Equity business. Mr.
Korangy co-founded Sight Sciences, Inc., a medical device company. Previously, he was a Managing Director at the Blackstone Group, one of the largest global investment firms, which he joined in 1996. During his more than 14 years at Blackstone, he served as both an advisor in the Restructuring/Special Situations business and as an investor in the Private Equity business. Mr.
Result of the review of the appropriateness of the compensation On the basis of the compensation reviews it carried out in the Fiscal Year, the Supervisory Board came to the conclusion that the compensation of the Management Board is appropriate in terms of both its structure and amount.
Result of the review of the appropriateness of the compensation Based on of the compensation reviews carried out in the fiscal year, the Supervisory Board reached the conclusion that the compensation of the Management Board is appropriate in terms of both its structure and amount.
For this purpose, compensation is deemed to have vested in the year in which the underlying activity has been fully performed and the entitlement to payment of the compensation is no longer subject to any conditions precedent or conditions subsequent. For the Long-Term Incentives shown in this Compensation Report, this corresponds to the year in which they are paid out.
For this purpose, compensation is deemed to have vested in the year in which the underlying activity has been fully performed and the entitlement to payment of the compensation is no longer subject to any conditions precedent or conditions subsequent. For the LTI, this corresponds to the year in which the compensation is paid out.
The allocation amount for the long-term variable compensation of the Chairperson of the Management Board can be set within a range of 105% (multiplier of 1.05) to 200% (multiplier of 2) and for the other Management Board members can be set within a range of 105% (multiplier of 1.05) to 150% (multiplier of 1.5) of the relevant base salary and in general amounts to 135% (multiplier of 1.35).
The LTI allocation amount of the Chairperson of the Management Board can be set within a range of 105% (multiplier of 1.05) to 200% (multiplier of 2) and for the other Management Board members can be set within a range of 105% (multiplier of 1.05) to 150% (multiplier of 1.5) of the relevant base salary and generally amounts to 135% (multiplier of 1.35).
Katarzyna Mazur-Hofsäß Chief Executive Officer for Care Enablement 7,000 Information on compliance with the maximum compensation can be found in the section “Compliance with maximum compensation (Allocations 2021).” 124 Table of Contents Malus and clawback The Supervisory Board is entitled to withhold or reclaim variable compensation components in cases of a Management Board member’s misconduct or non-compliance with his or her duties or internal Company guidelines, considering the characteristics of the individual case.
Katarzyna Mazur-Hofsäß Chief Executive Officer for Care Enablement 7,000 Information on compliance with the maximum compensation can be found in the section “Compliance with maximum compensation (Allocations 2022).” 116 Table of Contents Malus and clawback The Supervisory Board in accordance with the details of the relevant contractual provisions is entitled to withhold or reclaim variable compensation components in whole or in part in cases of a Management Board member’s misconduct or non-compliance with such member’s duties or internal Company guidelines, considering the characteristics of the individual case.
These performance targets form part of the Company’s primary key performance indicators or secondary financial performance indicators and support the execution of the Company’s long-term strategy. 131 Table of Contents The respective weighting of the individual performance targets for the Long-Term Incentive and their link to Fresenius Medical Care’s strategy are shown in the following diagram: Target values and target achievement (Allocation 2021) In the Fiscal Year, the Long-Term Incentive from the allocation for 2021 was earned.
These performance targets form part of the Company’s primary key performance indicators or secondary financial performance indicators and support the execution of the Company’s long-term strategy. 123 Table of Contents The respective weightings of the individual performance targets for the LTI and their link to Fresenius Medical Care’s strategy are shown in the following chart: Target values and target achievement (Allocation 2022) In the fiscal year 2025, the LTI from the allocation for 2022 was earned.
The amount reported here also includes an amount of €320 THOUS (corresponding to 40% of his annual base salary), which Mr. Fischer received in the Fiscal Year as compensation for the insurance contributions that would otherwise have to be paid for the period from October 1, 2023 to September 30, 2024. (7) The fringe benefits of Dr.
The amount reported for the fiscal year 2024 includes an amount of €320 K (corresponding to 40% of his annual base salary), which Martin Fischer received in 2024 as compensation for the insurance contributions that would otherwise have to be paid for the period from October 1, 2023, to September 30, 2024. (6) Dr.

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Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

18 edited+7 added6 removed17 unchanged
Biggest changeFresenius SE has granted to D-GmbH, for our benefit and that of our affiliates, an exclusive, worldwide, royalty-free, perpetual license to use “Fresenius Medical Care” in our names, and to use the Fresenius marks, including some combination marks containing the Fresenius name that were used by the worldwide dialysis business of Fresenius SE, and the “Fresenius Marks” as a trademark in all aspects of the renal business.
Biggest changeFresenius SE has granted D-GmbH for our benefit and that of our affiliates, a worldwide, royalty-free, perpetual license to use the Licensed Marks (including the Fresenius Marks) and/or the “Fresenius” name in our company names and as a trademark for products and services with an intended use or for medical indications in the field of extra-corporeal blood treatment and peritoneal dialysis.
The following descriptions are not complete and are qualified in their entirety by reference to those agreements, which have been filed with the SEC and the NYSE.
The following descriptions are not complete and are qualified in their entirety by reference to those agreements, which have been filed with the SEC.
Services agreements and products For information on our services agreements and products, see note 6 of the notes to the consolidated financial statements included in this report. 154 Table of Contents Financing For information on our related party financing arrangements, see note 6 and note 16 of the notes to the consolidated financial statements included in this report.
Services agreements and products For information on our services agreements and products, see note 6 of the notes to the consolidated financial statements included in this report. Financing For information on our related party financing arrangements, see note 6 and note 16 of the notes to the consolidated financial statements included in this report.
On October 4, 2024, BlackRock, Inc., Wilmington, Delaware, U.S., with respect to attributed voting rights, disclosed pursuant to Sections 33, 34 of the WpHG that 4.34% of the voting rights of the Company and pursuant to Section 38 of the WpHG that instruments relating to 0.16% of the voting rights of the Company were held as of October 1, 2024.
On January 21, 2026, BlackRock, Inc., Wilmington, Delaware, U.S., with respect to attributed voting rights, disclosed pursuant to Sections 33, 34 of the WpHG that 4.74% of the voting rights of the Company and pursuant to Section 38 of the WpHG that instruments relating to 0.34% of the voting rights of the Company were held as of January 16, 2026.
Bank of New York Mellon, our ADR depositary, informed us, that as of December 31, 2024, 38,873,048 ADRs were held of record by 2,121 U.S. holders. Two ADRs represent one share. Exhibit 2.1, “Description of Securities,” provides additional information regarding our ADRs and American Depositary Shares (ADSs).
Bank of New York Mellon, our ADR depositary, informed us, that as of December 31, 2025, 38,572,325 American Depositary Shares (ADS) were held of record by 2,007 U.S. holders. Two ADSs represent one share. Exhibit 2.1, “Description of Securities,” provides additional information regarding our ADRs and ADSs.
In addition, holders of voting securities of a German company listed on the regulated market ( Regulierter Markt ) of a German stock exchange or a corresponding trading segment of a stock exchange within the EU are, under Sections 33, 34 of the German Securities Trading Act ( Wertpapierhandelsgesetz or WpHG), obligated to notify the company of held or attributed holding whenever such holding reaches, exceeds or falls below certain thresholds, which have been set at 3%, 5%, 10%, 15%, 20%, 25%, 30%, 50% and 75% of a company’s outstanding voting rights.
Persons discharging managerial responsibilities include, inter alia, the members of management as well as supervisory boards. 143 Table of Contents In addition, holders of voting securities of a German company listed on the regulated market ( Regulierter Markt ) of a German stock exchange or a corresponding trading segment of a stock exchange within the EU are, under Sections 33, 34 of the German Securities Trading Act ( Wertpapierhandelsgesetz or WpHG), obligated to notify the company of held or attributed holding whenever such holding reaches, exceeds or falls below certain thresholds, which have been set at 3%, 5%, 10%, 15%, 20%, 25%, 30%, 50% and 75% of a company’s outstanding voting rights.
On July 14, 2022, Artisan Partners Asset Management Inc., Wilmington, Delaware, U.S., with respect to attributed voting rights, disclosed pursuant to Sections 33, 34 of the WpHG that 2.99% of the voting rights of the Company were held as of July 12, 2022.
On August 22, 2025, Artisan Partners Asset Management Inc., Wilmington, Delaware, U.S., with respect to attributed voting rights, disclosed pursuant to Sections 33, 34 of the WpHG that 2.99% of the voting rights of the Company were held as of August 19, 2025.
On January 6, 2023, Dodge & Cox International Stock Fund, San Francisco, California, U.S., disclosed pursuant to Section 33 of the WpHG that 3.00% of the voting rights of the Company were held as of January 3, 2023.
On February 28, 2025, Dodge & Cox International Stock Fund, San Francisco, California, U.S., disclosed pursuant to Section 33 of the WpHG that 5.00% of the voting rights of the Company were held as of February 24, 2025.
The Schedule 13G states that Dodge & Cox has sole voting power and sole dispositive power over such shares, and that clients of Dodge & Cox, including investment companies registered under the U.S.
Investment Advisers Act of 1940, is the beneficial owner of 7.4% of the Company’s shares. The Schedule 13G states that Dodge & Cox has sole voting power and sole dispositive power over such shares, and that clients of Dodge & Cox, including investment companies registered under the U.S.
Real property leases For information with respect to our principal properties, see “Item 4.D. Property, plant and equipment.” For discussion of related party leases, see note 6 of the notes to the consolidated financial statements included in this report. Trademarks Fresenius SE continues to own the name “Fresenius” and several marks containing “Fresenius” (hereinafter referred to as Fresenius Marks).
Real property leases For information with respect to our principal properties, see “Item 4.D. Property, plant and equipment.” For discussion of related party leases, see note 6 of the notes to the consolidated financial statements included in this report.
For threshold notifications furnished to us by third parties, see note 20 of the notes to the consolidated financial statements included in this report. 152 Table of Contents We have been informed that as of February 13, 2025, Fresenius SE owned 94,380,382 shares, or 32.2% of our outstanding shares.
For threshold notifications furnished to us by third parties, see note 20 of the notes to the consolidated financial statements included in this report. We have been informed that as of February 13, 2026, Fresenius SE owned 76,814,594, or 26.2%, of our issued shares.
On October 28, 2024, Harris Associates L.P., Wilmington, Delaware, U.S., with respect to attributed voting rights, disclosed pursuant to Sections 33, 34 of the WpHG that 4.95% of the voting rights of the Company were held as of October 23, 2024.
On April 16, 2025, Harris Associates L.P., Wilmington, Delaware, U.S., with respect to attributed voting rights, disclosed pursuant to Sections 33, 34 of the WpHG that 2.98% of the voting rights of the Company were held as of April 14, 2025.
However, under the WpHG, holders of voting securities of a German company listed on the regulated market (Regulierter Markt) of a German stock exchange or a corresponding trading segment of a stock exchange within the EU are obligated to notify a company of certain levels of holdings, as described above.
However, under the WpHG, holders of voting securities of a German company listed on the regulated market (Regulierter Markt) of a German stock exchange or a corresponding trading segment of a stock exchange within the EU are obligated to notify a company of certain levels of holdings, as described above. 144 Table of Contents The Else Kröner-Fresenius-Stiftung is the sole shareholder of Fresenius Management SE, the general partner of Fresenius SE, and has sole power to elect the supervisory board of Fresenius Management SE.
Since we are a foreign private issuer under the rules of the SEC, our directors and officers are not required to report their ownership of our equity securities or their transactions in our equity securities pursuant to Section 16 of the Securities and Exchange Act of 1934.
Commencing March 18, 2026, our directors and officers will be required to report their ownership of our equity securities and their transactions in our equity securities pursuant to Section 16 of the Securities and Exchange Act of 1934 but, because we are a foreign private issuer, they are not required to do so before that date.
See Item 7.B, “Related party transactions Other interests,” below. 153 Table of Contents B. Related party transactions In connection with the formation of FME AG, and the combination of the dialysis businesses of Fresenius SE and W.R.
In addition, based on the most recent information available, the Else Kröner-Fresenius-Stiftung owns approximately 27% of the Fresenius SE ordinary shares. See Item 7.B, “Related party transactions Other interests,” below. B. Related party transactions In connection with the formation of FME AG, and the combination of the dialysis businesses of Fresenius SE and W.R.
This notification obligation applies once the volume of all transactions of such person conducted within a calendar year exceeds a total amount of €20,000. Persons discharging managerial responsibilities include, inter alia, the members of management as well as supervisory boards.
This notification obligation applies once the volume of all transactions of such person conducted within a calendar year exceeds a total amount of €50,000.
On December 16, 2022, Dodge & Cox, San Francisco, California, U.S., with respect to attributed voting rights, disclosed pursuant to Sections 33, 34 of the WpHG that 5.03% of the voting rights of the Company were held as of December 13, 2022.
On July 9, 2025, Dodge & Cox International, San Francisco, California, U.S., disclosed pursuant to Section 33 of the WpHG that 4.98% of the voting rights of the Company were held as of July 3, 2025. According to an amended Schedule 13G filed with the SEC on February 13, 2024, Dodge & Cox, an investment adviser registered under the U.S.
Fresenius SE and Fresenius Medical Care Deutschland GmbH (D-GmbH) entered into agreements containing the following provisions (Trademark License Agreement).
Fresenius SE and Fresenius Medical Care Deutschland GmbH (D-GmbH) entered into the original Trademark License Agreement dated September 27, 1996 (Original Trademark License Agreement), which remains in force after our Conversion and related deconsolidation from Fresenius SE.
Removed
According to an amended Schedule 13G filed with the SEC on February 13, 2024, Dodge & Cox, an investment adviser registered under the U.S. Investment Advisers Act of 1940, is the beneficial owner of 7.4% of the Company’s shares.
Added
On March 7, 2025, Else Kröner-Fresenius-Stiftung, Bad Homburg v.d.Höhe, Germany, with respect to attributed voting rights, disclosed pursuant to Sections 33, 34 of the WpHG that 28.55% of the voting rights of the Company were held as of March 4, 2025.
Removed
The Else Kröner-Fresenius-Stiftung is the sole shareholder of Fresenius Management SE, the general partner of Fresenius SE, and has sole power to elect the supervisory board of Fresenius Management SE. In addition, based on the most recent information available, the Else Kröner-Fresenius-Stiftung owns approximately 27% of the Fresenius SE ordinary shares.
Added
Trademarks Fresenius SE owns the name “Fresenius” and several marks containing “Fresenius” (Fresenius Marks) also after our Conversion and related deconsolidation from Fresenius SE.
Removed
D-GmbH, for our benefit and that of our affiliates, has also been granted a worldwide, royalty-free, perpetual license to use the “Fresenius Marks” in the former National Medical Care non-renal business if it is used as part of a trademark containing the words “Fresenius Medical Care” together with one or more descriptive words, such as “Fresenius Medical Care Vascular Care” or “Fresenius Medical Care Physician Services.” We and our affiliates have the right to use “Fresenius Marks” in other medical businesses only with the consent of Fresenius SE.
Added
The parties agreed to some amendments/clarifications set out in the Long Form of Amendment to the Original Trademark License Agreement dated December 23, 2025 (as amended, Trademark License Agreement).
Removed
Fresenius SE may not unreasonably withhold its consent.
Added
In the field of renal care, the license is generally exclusive. For renal pharmaceuticals exclusivity only applies to pharmaceuticals falling into specific categories. This amended scope of the license shall only be governed by the Trademark License Agreement and reflects the current scope of business of Fresenius SE and the Company.
Removed
Fresenius SE will not use or license third parties to use the Fresenius Marks in the renal business worldwide and will not use the Fresenius Marks alone or in combination with any other words in the US and Canada, except in combination with one or more additional words such as “Pharma Home Care” as a service mark in connection with its home care business.
Added
We and our affiliates have the right to use the Licensed Marks, including the Fresenius Marks and/or the “Fresenius” name outside the field of extra-corporeal blood treatment and peritoneal dialysis only with the consent of Fresenius SE.
Removed
The Trademark License Agreement remains in full force after our Conversion and related deconsolidation from Fresenius SE with some amendments/clarification concerning, inter alia , standards regarding the use of the “Fresenius Marks” (details to be defined in Branding Guidelines jointly developed by Fresenius SE and us), limits on the current and future stand-alone use of the “Fresenius” name by us, 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.
Added
Regardless of whether or not exclusivity applies, Fresenius SE or its affiliates shall not use or license third parties to use the designations “Fresenius Medical Care”, “a Fresenius Medical Care company”, or one of the terms “renal”, “kidney”, “nephro,” or “dialysis” (incl. corresponding translations) as addition to the Fresenius Mark or the “Fresenius” name or any confusingly similar designations. 145 Table of Contents The “Fresenius” Name and Fresenius Marks (details to be defined in Branding Guidelines jointly developed by Fresenius SE and the Company) may only be used by us in combination with Medical Care, any of the terms Kidney, Renal, Dialysis, Nephro, or the addition “a Fresenius Medical Care company”.
Added
In the Trademark License Agreement customary termination rights for Fresenius SE in case of a material breach, in the event of a change of control and in the event we decide to change our legal company name were introduced. Furthermore, reporting obligations were introduced regarding any harmful use of the Licensed Marks and/or the “Fresenius” name.