株探米国株
英語
エドガーで原本を確認する
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13A-16 OR 15D-16 UNDER THE

SECURITIES EXCHANGE ACT OF 1934

For the month of November 2024.

Commission file number: 001-32749

FRESENIUS MEDICAL CARE AG

(Translation of registrant’s name into English)

Else-Kröner-Strasse 1

61346 Bad Homburg

Germany

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F  ☒

Form 40-F  ☐

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FRESENIUS MEDICAL CARE AG

Interim Report of Financial Condition and Results of Operations for the three and nine months ended September 30, 2024 and 2023

Page

FINANCIAL INFORMATION

Management’s discussion and analysis

Forward-looking statements

2

Financial condition and results of operations

5

Overview

5

Discussion of measures

8

Results of operations, financial position and net assets

14

Recently issued accounting standards

24

Interim Financial Statements (unaudited)

Consolidated statements of income

25

Consolidated statements of comprehensive income

26

Consolidated balance sheets

27

Consolidated statements of cash flows

28

Consolidated statement of shareholders’ equity

29

Notes to the interim consolidated financial statements

30

Quantitative and qualitative disclosures about market risk

57

Controls and procedures

58

OTHER INFORMATION

Legal proceedings

59

Exhibits

60

Signatures

61

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FRESENIUS MEDICAL CARE AG

FINANCIAL INFORMATION

Management’s discussion and analysis

In this report, “FME AG,” or the “Company,” “we,” “us” or “our” refers to Fresenius Medical Care AG or to Fresenius Medical Care AG and its subsidiaries on a consolidated basis, as the context requires. You should read the following discussion and analysis of the results of operations of the Company and its subsidiaries in conjunction with our unaudited interim consolidated financial statements and related notes contained elsewhere in this report and our disclosures and discussions in our consolidated financial statements as of and for the year ended December 31, 2023, prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB), the “IFRS® Accounting Standards,” using the euro as our reporting currency, included in our Annual Report on Form 20-F for the year ended December 31, 2023 (our 2023 Form 20-F).

The term “Care Enablement” refers to our Care Enablement operating segment, which is primarily engaged in the distribution of products and equipment and includes research and development (R&D), manufacturing, supply chain and commercial operations, as well as supporting functions, such as regulatory and quality management. The term “Care Delivery” refers to the Care Delivery operating segment, which is primarily engaged in providing services for the treatment of chronic kidney disease (CKD), end-stage renal disease (ESRD) and other extracorporeal therapies, including value and risk-based care programs. Care Delivery also includes the pharmaceutical products business and the income from equity method investees related to the sale of certain renal pharmaceuticals from Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP), which are used in our clinics to provide health care services to our patients. Our operating segments are determined based upon how the Company manages its businesses and allocates resources with responsibilities by products and services and is aligned to the financial information that is presented on a quarterly basis to the chief operating decision maker.

Our Global Medical Office, which seeks to optimize medical treatments and clinical processes within the Company and supports both Care Delivery and Care Enablement, is centrally managed and its profit and loss are allocated to the segments. Similarly, we allocate costs related primarily to headquarters’ overhead charges, including accounting and finance as well as certain human resources, legal and IT costs, as we believe that these costs are attributable to the segments and used in the allocation of resources to Care Delivery and Care Enablement. These costs are allocated at budgeted amounts, with the difference between budgeted and actual figures recorded at the corporate level. However, certain costs, which relate mainly to shareholder activities, management activities, global internal audit and the remeasurement of certain investments and virtual power purchase agreements, are not allocated to a segment but are accounted for as corporate expenses. These activities do not fulfill the definition of a segment according to IFRS 8, Operating Segments and are also reported separately as Corporate (Corporate). Financing is a corporate function which is not controlled by the operating segments. Therefore, the Company does not include interest expense relating to financing as a segment measurement. In addition, the Company does not include income taxes as we believe taxes are outside the segments’ control. See note 13 of the notes to the consolidated financial statements (unaudited) included in this report for a further discussion on our operating segments.

At an extraordinary general meeting (EGM) of the Company held on July 14, 2023, the shareholders of the Company approved a proposal to change the legal form of the Company from a partnership limited by shares (Kommanditgesellschaft auf Aktien – KGaA) into a stock corporation (Aktiengesellschaft – AG), (the Conversion). Upon effectiveness of the Conversion, which occurred upon registration of the Conversion with the competent commercial register on November 30, 2023, the Company’s former general partner exited the Company, Fresenius SE & Co. KGaA (Fresenius SE) ceased to control (as defined by IFRS 10, Consolidated Financial Statements) the Company and the Company ceased to be a member of the Fresenius SE consolidated group.

The abbreviations “THOUS” and “M” are used to denote the presentation of amounts in thousands and millions, respectively. The term “Constant Currency” or at “Constant Exchange Rates” means that we have translated local currency revenue, operating income, net income attributable to shareholders of FME AG and other items for the current reporting period into euro using the prior year exchange rates to provide a comparable analysis without effect from exchange rate fluctuations on translation, as described below under “Financial condition and results of operations – II. Discussion of measures – Non-IFRS® measures.”

1

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Forward-looking statements

This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). When used in this report, the words “outlook,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “guidance,” “target” and similar expressions are generally intended to identify forward looking statements. Although we believe that the assumptions and expectations reflected in such forward-looking statements are reasonable, forward-looking statements are inherently subject to risks and uncertainties, many of which cannot be predicted with accuracy and some of which might not be anticipated. Additionally, subsequent events and actual results, financial and otherwise, have differed in the past and, going forward, could differ materially from those set forth in or contemplated by the forward-looking statements contained elsewhere in this report. We have based these forward-looking statements on current estimates and assumptions made to the best of our knowledge. By their nature, such forward-looking statements involve risks, uncertainties, assumptions and other factors which could cause actual results, including our financial condition and profitability, to differ materially, positively or negatively, relative to the results expressly or implicitly described in or suggested by these statements. Moreover, forward-looking estimates or predictions derived from third parties’ studies or information may prove to be inaccurate. Consequently, we cannot give any assurance regarding the future accuracy of the opinions set forth in this report or the actual occurrence of the projected developments described herein. In addition, even if our future results meet the expectations expressed here, those results may not be indicative of our performance in future periods.

These risks, uncertainties, assumptions, and other factors, including associated costs, could cause actual results to differ from our projected results and include, among others, the following:

changes in governmental and private payor reimbursement for our complete products and services portfolio, including the United States (U.S.) Medicare reimbursement system for dialysis and other health care services, including potentially significant changes to the Patient Protection and Affordable Care Act of 2010 (Pub.L. 111-148), as amended by the Health Care and Education Reconciliation Act (Pub.L. 111-152) (collectively, ACA) that could result from future efforts to revise, repeal or replace the ACA, and changes by regulators to certain reimbursement models, such as the ESRD Treatment Choices (ETC) model and the Comprehensive Kidney Care Contracting (CKCC) model, which could significantly impact performance under these models in unanticipated ways;
our ability to accurately interpret and comply with complex current and future government regulations applicable to our business including sanctions and export control laws and regulations, laws and regulations in relation to environmental, social and governance topics, the impact of health care, tax and trade law reforms, in particular the Organisation for Economic Co-operation and Development initiatives for the reallocation of taxation rights to market countries (Pillar one) and introduction of a global minimum tax (Pillar two) as well as potential U.S. tax reform, antitrust and competition laws in the countries and localities in which we operate, other government regulation including, in the U.S., the federal Medicare and Medicaid Fraud and Abuse Amendments of 1977, as amended (the Anti-Kickback Statute), the False Claims Act, the federal Physician Self-Referral Law (the Stark Law), the Civil Monetary Penalty Law, the Health Insurance Portability and Accountability Act, the Health Information Technology for Economic and Clinical Health Act, the Foreign Corrupt Practices Act (FCPA), the Federal Trade Commission Non-Compete Clause Rule (if and when it becomes effective) and other similar state laws, and the Food, Drug and Cosmetic Act, as well as the U.S. Securities and Exchange Commission’s (SEC) climate disclosure rules (if and when they become effective) and, outside the U.S., inter alia, the European Union (EU) Medical Device Regulation, the EU General Data Protection Regulation, the EU Taxonomy Regulation, the EU Corporate Sustainability Reporting Directive, the EU Artificial Intelligence Act, the NIS 2 Directive (Directive (EU) 2022/2555), the German Act on Human Rights Due Diligence in Supply Chains, the EU Due Diligence Directive, the two invoice policy, “Buy China” policy, volume-based procurement policies and the Tendering and Bidding Law in China and other related local legislation as well as other comparable regulatory regimes in many of the countries where we supply health care services and/or products.

In the U.S., the interpretation of these statutes and the validity of existing interpretations by the agencies that administer such statutes may be subject to increased uncertainty as a result of the U.S. Supreme Court’s opinion in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce, 603 U.S. (2024) (Loper) in June 2024. Loper overruled the so-called “Chevron Doctrine” under which administrative agencies were accorded significant deference in their interpretation of the statutes they administer. The Loper opinion held that the U.S. Administrative Procedure Act requires courts to “exercise their independent judgment in deciding whether an agency has acted within its statutory authority.” While the effects of the Loper decision will become apparent over the succeeding months and years, it is possible that the decision could result in additional litigation challenging regulations, guidance, and decisions issued by agencies such as the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid (CMS), concern over the enforceability of such regulations until tested in court, challenges to CMS guidance in areas such as coverage billing requirements, coding decisions, add-on payments and procedure categorization and the Medicaid Drug Rebate Program, as well as the validity of advisory opinions and safe-harbor regulations issued by the Office of Inspector General of the Department of Health and Human Services under the Anti-Kickback Statute. Such additional litigation could also result in additional uncertainty regarding such regulations and interpretations due to conflicting interpretations and rulings issued by courts in different jurisdictions. Given the uncertainty created by the Loper decision, we cannot predict its potential impact on our financial condition and results of operations at this time;

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FRESENIUS MEDICAL CARE AG

the influence of private payors (including integrated care organizations, commercial insurance and Medicare Advantage plans, also known as Medicare Part C, offered by private health insurers approved by CMS to provide their members with Medicare Part A, Part B and usually Part D benefits (Medicare Advantage or MA plans), as well as efforts by these organizations to manage costs by limiting health care benefits, narrowing their networks, reducing provider reimbursement, implementing prior authorization requirements and/or restricting options for patient funding of health insurance premiums, including efforts by employer group health plans (EGHPs) and commercial insurers to make dialysis reimbursement payments at a lower rate as a result of the U.S. Supreme Court’s ruling in Marietta Memorial Hospital Employee Health Benefit Plan, et al. v. DaVita Inc. et al. 142 S. Ct. 1968 (2022) (Marietta), particularly if the U.S. Congress fails to enact legislation that would reverse the effects of that decision;
the impact of worldwide pandemics (for example, the severe acute respiratory syndrome coronavirus 2 and the related Coronavirus disease (COVID-19) pandemic), including, without limitation, a significant increase in mortality of patients with chronic kidney diseases as well as an increase in persons experiencing renal failure, the impacts of global viruses on our patients, caregivers, employees, suppliers, supply chain, business and operations, and consequences of economic downturns resulting from global pandemics;
our ability to attract and retain skilled employees and risks that competition for labor, high turnover rates and meaningfully higher personnel costs as well as legislative, union, or other labor-related activities or changes have and will continue to result in significant increases in our operating costs, decreases in productivity and partial suspension of operations and to impact our ability to address additional treatments and growth recovery;
the increase in raw material, energy, labor and other costs, including an impact from these cost increases and/or supply chain impacts on our cost savings initiatives and increases due to geopolitical conflicts in certain regions (for example, impacts related to the war between Russia and Ukraine (Ukraine War)) as well as the impact that inflation may have on a potential impairment of our goodwill, investments or other assets as noted above;
the outcome of litigation as well as government and internal investigations;
launch of new technology, introduction of generic or new pharmaceuticals and medical devices that compete with our products or services, advances in medical therapies, including the increased utilization of pharmaceuticals that reduce the progression of CKD and its precursors, xenotransplantation research and development and new market entrants that compete with our businesses (further information regarding the impact of certain pharmaceuticals that reduce the progression of CKD and our analysis of their impact on our cash flow projections and goodwill sensitivity assessments can be found in note 1 of the notes to the consolidated financial statements (unaudited) included in this report);
product liability risks and the risk of recalls of our products by regulators;
our ability to continue to grow our health care services and products businesses, organically and through acquisitions, including, with respect to acquisitions, the effects of increased enforcement of antitrust and competition laws, and to implement our strategy;
the impact of currency and interest rate fluctuations, including the heightened risk of fluctuations as a result of geopolitical conflicts in certain regions, the impact of the current macroeconomic inflationary environment on interest rates and a related effect on our borrowing costs;
volatility in the valuation of financial instruments connected to energy prices or energy production volumes (such as virtual power purchase agreements (vPPAs)), including the heightened risk of volatility as a result of geopolitical conflicts in certain regions;
potential impairment of our goodwill, investments or other assets due to decreases in the recoverable amount of those assets relative to their book value, particularly as a result of sovereign rating agency downgrades coupled with an economic downturn in various regions or as a result of geopolitical conflicts in certain regions;
our ability to protect our information technology systems and protected health information against cyber security attacks and to prevent other data privacy or security breaches of our data (including data held by our third-party service providers), current and potential litigation arising from cybersecurity breaches and the potential effects on our reputation, customer or vendor relationships, business operations or competitiveness of any cybersecurity incidents we or our service providers may incur, as well as our ability to effectively capture efficiency goals and align with contractual and other requirements related to data offshoring activities;
changes in our costs of purchasing and utilization patterns for pharmaceuticals and our other health care products and supplies, the inability to procure raw materials or disruptions in our supply chain;

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potential increases in tariffs and trade barriers that could result from withdrawal by single or multiple countries from multilateral trade agreements or the imposition of sanctions, retaliatory tariffs and other countermeasures in the wake of trade disputes and geopolitical conflicts in certain regions;
collectability of our receivables, which depends primarily on the efficacy of our billing practices, the financial stability and liquidity of our governmental and private payors, services from third-party clearinghouses, customers and intermediaries as well as payor strategies to delay, dispute or thwart the collection process;
our ability to secure contracts and achieve cost savings and desired clinical outcomes in our value-based care operations and other health care risk management programs in which we participate or intend to participate;
the greater size, market power, experience and product offerings of certain competitors in certain geographic regions and business lines;
the use of accounting estimates, judgments and accounting pronouncement interpretations in our consolidated financial statements;
our ability to achieve projected cost savings within the proposed timeframe as part of the previously announced transformation of our operating structure and steps to achieve cost savings (FME25 Program) as well as the possibility that changing or increasing responsibilities of our employees as a result of this transformation could require additional resources in the short-term;
our ability to improve our financial performance through the divestiture of non-core and dilutive assets; and
our ability to achieve projected price increases for our products and corresponding services.

Important factors that could contribute to such differences are noted in “Financial condition and results of operations – I. Overview” below, in note 11 of the notes to the consolidated financial statements (unaudited) included in this report, in note 25 of the notes to the consolidated financial statements included in our 2023 Form 20-F, as well as under “Risk Factors,” “Business overview,” “Operating and financial review and prospects,” and elsewhere in that report. Further information regarding our efforts to address various environmental, social and governance issues can be found within our Non-financial Group Report available at www.freseniusmedicalcare.com/en/investors/investors-overview/. In referencing our Non-financial Group Report and furnishing this website address in this report, however, we do not intend to incorporate any content from our Non-financial Group Report or information on our website into this report, and any information in our Non-financial Group Report or on our website should not be considered to be part of this report, except as expressly set forth herein.

Our business is also subject to other risks and uncertainties that we describe from time to time in our periodic public filings which can be accessed at the U.S. Securities and Exchange Commission website at www.sec.gov. Developments in any of these areas could cause our results to differ materially from the results that we or others have projected or may project.

The actual accounting policies, the judgments made in the selection and application of these policies, as well as the sensitivities of reported results to changes in accounting policies, assumptions and estimates, are additional factors to be considered along with our interim financial statements and the discussion under “Results of operations, financial position and net assets” below. For a discussion of our critical accounting policies, see note 2 of the notes to the consolidated financial statements included in our 2023 Form 20-F.

Rounding adjustments applied to individual numbers and percentages shown in this and other reports may result in these figures differing immaterially from their absolute values. Some figures (including percentages) in this report have been rounded in accordance with commercial rounding conventions. In some instances, such rounded figures and percentages may not add up to 100% or to the totals or subtotals contained in this report. Furthermore, totals and subtotals in tables may differ slightly from unrounded figures contained in this report due to rounding in accordance with commercial rounding conventions. A dash (–) indicates that no data were reported for a specific line item in the relevant financial year or period, while a zero (0) is used when the pertinent figure, after rounding, amounts to zero.

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Financial condition and results of operations

I. 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. 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 supply dialysis clinics we own, operate or manage with a broad range of products and also sell dialysis products to other dialysis service providers. We sell our health care products to customers in around 140 countries and we also use them in our own health care service operations. Our dialysis business is therefore vertically integrated. Our other health care services include value and risk-based care programs, pharmacy services, vascular specialty services as well as ambulatory surgery center services, physician nephrology practice management and ambulant treatment services. We estimate that the size of the global dialysis market was approximately €81 billion in 2023. 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. 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. 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.

Significant U.S. reimbursement developments

The majority of health care services we provide are paid for by governmental institutions. For the nine months ended September 30, 2024, approximately 26% 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. The stability of reimbursement in the U.S. has been affected by (i) the ESRD prospective payment system (ESRD PPS), (ii) the U.S. federal government across the board spending cuts in payments to Medicare providers commonly referred to as “U.S. Sequestration” and (iii) the reduction to the ESRD PPS rate to account for the decline in utilization of certain drugs and biologicals associated with dialysis pursuant to the American Taxpayer Relief Act of 2012 as subsequently modified under the Protecting Access to Medicare Act of 2014 (PAMA). See detailed discussions on these and further legislative developments below:

Under the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), for patients with Medicare coverage, all ESRD payments for dialysis treatments are made under the ESRD PPS, a single bundled payment rate which provides a fixed payment rate, encompassing substantially all goods and services provided during the dialysis treatment. MIPPA further created the ESRD Quality Incentive Program (QIP) under which dialysis facilities in the U.S. that fail to achieve annual quality standards established by CMS could have base payments reduced in a subsequent year by up to 2%.
Additionally, 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. Additionally, the Statutory Pay-As-You-Go Act of 2010 (Statutory PAYGO) requires that if the Congressional Budget Office determines that Congress has passed legislation increasing the federal budget deficit, a 4% sequester cut for Medicare program payments would become effective. To date, Congress has passed legislation increasing the federal deficit on a number of occasions subsequent to the passage of Statutory PAYGO, but has always acted to prevent such sequestration from becoming effective. Spending cuts pursuant to the U.S. Sequestration have adversely affected our operating results in the past and will continue to do so. 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. Changes in payment methodologies and funding or payment requirements of (without limitation) the ESRD PPS, the Physician Fee Schedule, the Clinical Laboratory Fee Schedule and the Ambulatory Surgical Center Payment System may have material effects on our operating results. We may also experience changes in the interpretation of government regulations by the courts. We have very little opportunity to influence or predict the magnitude of many of those changes.

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On November 1, 2024, CMS issued a final rule for the ESRD PPS rate for calendar year (CY) 2025 which CMS anticipates will result in an increase in total payments to ESRD facilities of 2.7%. The 2.7% increase reflects a 1.0% increase in the base rate per treatment to $273.82, plus additional adjustments for inflation and productivity (as mandated by the ACA) and wage index budget neutrality adjustments. CMS notes that the 1.0% target for ESRD outlier payments was achieved in CY 2023 and expects such payments to represent approximately 1% of the total in CY 2025. Additionally, CMS finalized an additional $0.4601 be added to the base rate to account for Korsuva™, a prescription medication used for the treatment of moderate-to-severe pruritus associated with CKD for adults undergoing hemodialysis. The final Acute Kidney Injury payment rate for CY 2025 is equal to the CY 2025 ESRD PPS base rate. In addition, the final rule confirmed that, effective January 1, 2025, oral only drugs (including phosphate binders) would be reimbursed under the ESRD PPS using the transitional drug add-on payment adjustment (TDAPA), as described in the CY 2016 ESRD PPS final rule (80 FR 69027), and subsequent rules and would no longer be paid for under Medicare Part D, which could have an adverse effect on our business, financial condition and results of operations in future periods. To account for operational costs related to ESRD facilities providing phosphate binders, CMS will provide an additional $36.41 monthly increase to the TDAPA.
Under the ESRD QIP, CMS assesses the total performance of each facility on a set of quality measures specified per payment year and applies up to a 2% payment reduction to facilities that do not meet a minimum total performance score. In the CY 2025 final rule, CMS replaced the Kt/V Dialysis Adequacy Comprehensive clinical measure with a Kt/V Dialysis Adequacy measure topic, which will be comprised of four individual Kt/V measures and scored based on a separate set of performance standards for each of those measures. CMS also removed the National Healthcare Safety Network Dialysis Event reporting measure from the ESRD QIP measure set beginning with PY 2027.
On November 1, 2024, CMS announced the CY 2025 final rule for hospital outpatient and ambulatory surgery center (ASC) payment systems. The final rule updates the ASC payment system for CY 2025 to generally increase the reimbursement rates for the range of procedures provided in an ASC. The average increase is 2.9% compared to the prior year. On November 1, 2024, CMS also issued the final Physician Fee Schedule for CY 2025. The CY 2025 Physician Fee Schedule conversion factor is $32.35, a decrease of $0.94 (or 2.8%) from the CY 2024 conversion factor of $33.29.

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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. However, any significant decreases in reimbursement under Medicare, commercial insurance or Medicare Advantage plans, or in patient access to commercial insurance or Medicare Advantage plans could have material adverse effects on our health care services business and, because the demand for dialysis products is affected by Medicare reimbursement, on our products business. 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 United States Supreme Court’s Marietta ruling makes it easier for health plans to design plan benefits for Medicare eligible ESRD patients in a way that makes commercial insurance relatively less attractive to ESRD patients and Medicare relatively more attractive. The Marietta ruling could also result in certain EGHPs reducing the benefits offered for dialysis, which could, depending on the number of patients impacted, have a material and adverse impact on our business, financial condition and results of operations. In December 2023, a bipartisan group of six members of the House reintroduced the Restore Protections for Dialysis Patients Act (H.R. 6860), which would address the Marietta decision. The bill includes updated language which would restore the understanding 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. In September 2024, a companion bill was introduced on a bipartisan basis in the U.S. Senate (S. 5018). As Medicare and Medicaid reimbursement rates are generally lower than the reimbursement rates paid by commercial insurers, a shift of commercially insured patients to Medicare and Medicaid could have a material adverse impact on our business, financial condition and results of operations in 2024 and beyond. There can be no assurance that this proposal or any other legislation to address the Marietta decision will be enacted. For additional information regarding these regulatory matters, see “Information on the Company—Regulatory and Legal Matters—Health Care Reform” in our 2023 Form 20-F.

For additional information, see “Risk Factors” included in our 2023 Form 20-F.

Premium assistance programs

The operation of charitable insurance premium assistance programs such as that offered by the American Kidney Fund (AKF) has received increased attention over the last few years by CMS and state insurance regulators and legislators. The result may be a regulatory framework that differs from the current framework or that varies from state to state. Even in the absence of actions by CMS or state regulators and legislatures to restrict the access that patients currently have to premium assistance programs, insurers are likely to continue efforts to thwart charitable premium assistance by premium assistance programs to our patients. If successful in a material area or scope of our U.S. operations, these efforts would have a material adverse impact on our business and operating results.

One such law that was enacted is AB290 in California (U.S.). Upon enactment, we, along with other providers and the AKF, filed suit challenging the validity of the law. Jane Doe, et al. v. Xavier Becerra, et al., 8:19-cv-02105, U.S. District Court for the Central District of California, Southern Division. In December 2019, the court issued a preliminary injunction staying implementation of the law. On January 9, 2024, the court issued a summary judgment decision which, among other things, upheld the provisions limiting reimbursement paid to providers who donate to the AKF when such reimbursement relates to services provided to patients who receive AKF support. On May 9, 2024, the court issued a final judgment, but stayed entry of such judgment while the parties appeal.

Executive order-based models

On July 10, 2019, an Executive Order on advancing kidney health was signed in the United States. Among other things, the order instructed the Secretary of the U.S. Department of Health and Human Services (HHS) to develop new Medicare payment models to encourage identification and earlier treatment of kidney disease as well as increased home dialysis and transplants. One of those models, for which the rule was finalized on September 29, 2020 and later amended through finalized changes on October 29, 2021, the ETC model, is a mandatory model that creates financial incentives for home treatment and kidney transplants with a start date in January 2021 and ending in June 2027. This model applies both upside and downside payment adjustments to claims submitted by physicians and dialysis facilities for certain Medicare home dialysis patients over the span of six and one-half years. Participants in this model are based on a random selection of 30% of the Hospital Referral Regions. As of September 30, 2024, 979 of our U.S. dialysis facilities, representing approximately 35% of our U.S. dialysis facilities, are within the random selection of Hospital Referral Regions and therefore are in areas selected for participation in the model. An initial upside-only payment, Home Dialysis Payment Adjustment (HDPA), was applied for the first three years of the model, beginning in January 2021, in decreasing payment adjustments ranging from 3% in the first HDPA payment year, to 2% in the second HDPA payment year, and to 1% in the final HDPA payment year. This model also includes a Performance Payment Adjustment (PPA) beginning in July 2022. PPA payments will be a combined calculation of home dialysis (home, self-dialysis and nocturnal in-center) and transplant (living donor transplants and transplant waitlist) rates based upon a participant’s historic performance and/or increasingly weighted benchmark data from comparison geographic areas. CMS utilizes a two-tiered approach in PPA scoring to stratify participants with a high volume of beneficiaries who are dual-eligible for Medicare and Medicaid or Low Income Subsidy recipients. Possible PPA payment adjustments increase over time and will range from (5%) to 4% in the first PPA payment year (beginning July 2022) for both physicians and facilities and increase to (9%) and 8% for physicians and (10%) and 8% for facilities in the final PPA payment year (ending in June 2027).

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On October 31, 2022, CMS finalized refinements to the ETC model, including a change to the improvement in scoring methodology and a change to the requirements related to flexibilities regarding furnishing and billing kidney disease patient education services under the ETC model. CMS also discussed its intent to publish participant-level performance data. These changes did not result in additional estimated savings to the Medicare program. At this time, our payment adjustments from the ETC model have resulted in a net positive adjustment. In October 2024, CMS released the performance scores for 2022 participants in which the majority of the KCEs organized by Interwell Health, our value and risk-based care subsidiary, qualified as high performers in various quality metrics.

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. 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 Kidney Care Entity (KCE). 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. Under the global model, the KCE is responsible for 100% of the total cost of care for all Medicare Part A and B services for aligned beneficiaries, and under the professional model, the KCE is responsible for 50% of such costs. Applications for the voluntary models were submitted in January 2020. We submitted 25 CKCC applications to participate in the professional model and were also included in four other CKCC applications submitted by nephrologists. All 29 of these KCE applications were accepted in June 2020. Of the 29 accepted applications, 28 KCEs have elected to participate in the implementation period, which started on October 15, 2020, and provided a start-up period during which the KCE is not at financial risk. The KCEs started assuming financial risk at the start of the first performance year on January 1, 2022. Of the 28 KCEs participating in the implementation period, we moved forward with 20 of the KCEs during the first performance year. The CKCC model is expected to run through 2026. For the second performance year in the CKCC model, we submitted 4 additional CKCC applications (3 under the professional option and 1 under the global option) and were also included in one other CKCC application submitted by nephrologists under the global option. All 5 applications were accepted, though we notified CMS that we will not move forward with one of those applications. The accepted KCEs started assuming financial risk as of January 1, 2023. As of September 2024, approximately 54,000 patients were aligned to KCEs in which we participated.

Company structure

For a description of our structure, especially as relates to our operating segments, see “Management’s discussion and analysis” above as well as note 13 of the notes to the consolidated financial statements (unaudited) included in this report.

II. Discussion of measures

Non-IFRS measures

Certain of the following financial measures and other financial information as well as discussions and analyses set out in this report include measures that are not defined by IFRS Accounting Standards (Non-IFRS Measures). 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. Non-IFRS financial measures should not be viewed or interpreted as a substitute for financial information presented in accordance with IFRS Accounting Standards.

Constant Exchange Rates or Constant Currency (Non-IFRS Measure)

Our presentation of some financial measures used in this report such as changes in revenue, operating income and net income attributable to shareholders of FME AG (or net income) includes the impact of translating local currencies to our reporting currency for financial reporting purposes. 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. Once we translate the local currency for the constant currency, we then calculate the change, as a percentage, of the current period calculated using the prior period exchange rates versus the prior period. This resulting percentage is a Non-IFRS Measure referring to a change as a percentage at constant currency. These currency-adjusted financial measures are identifiable by the designated terms “Constant Exchange Rates” or “Constant Currency.”

The primary key performance indicators are presented both in accordance with IFRS Accounting Standards and at Constant Currency. Each of these indicators presented at Constant Currency is considered a non-IFRS measure. 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.

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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. In addition, under our long-term incentive plans, we measure the attainment of certain predetermined financial targets for revenue growth and net income growth in Constant Currency. However, we limit our use of Constant Currency period-over-period changes to a measure for the impact of currency fluctuations on the translation of local currency into euro. We do not evaluate our results and performance without considering both:

(1) period-over-period changes in revenue, operating income, net income attributable to shareholders of FME AG and other items prepared in accordance with IFRS Accounting Standards, and
(2) Constant Currency changes in revenue, operating income, net income attributable to shareholders of FME AG and other items.

We caution the readers of this report not to consider these measures in isolation, but to review them in conjunction with changes in revenue, operating income, net income attributable to shareholders of FME AG and other items prepared in accordance with IFRS Accounting Standards. We present the growth rate derived from non-IFRS measures next to the growth rate derived from IFRS Accounting Standards measures such as revenue, operating income, net income attributable to shareholders of FME AG and other items. As the reconciliation is inherent in the disclosure included within “Results of operations, financial position and net assets,” below, we believe that a separate reconciliation would not provide any additional benefit.

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)”). Additionally, we further adjust ROIC for costs related to Legacy Portfolio Optimization incurred during the last twelve months to increase comparability of the underlying financial figures of certain Management Board compensation performance targets with the Company’s operating performance and to adequately recognize the actual performance of the members of the Management Board. ROIC expresses how efficiently we allocate the capital under our control or how well we employ our capital with regard to investment projects. The 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

September 30,

June 30,

March 31,

December 31,

September 30,

2024

    

2024

    

2024

    

2024

    

2023

    

2023

Total assets

32,511

33,896

34,336

33,930

35,635

Plus: Cumulative goodwill amortization and impairment loss

519

565

519

629

703

Minus: Cash and cash equivalents(1)

(1,387)

(1,112)

(1,192)

(1,427)

(1,574)

Minus: Deferred tax assets(1)

(296)

(281)

(279)

(292)

(304)

Minus: Accounts payable to unrelated parties(1)

(779)

(793)

(748)

(775)

(762)

Minus: Accounts payable to related parties

(73)

(100)

(110)

(123)

(119)

Minus: Provisions and other current liabilities(2)

(2,671)

(3,062)

(3,026)

(2,936)

(3,235)

Minus: Income tax liabilities(1)

(227)

(189)

(280)

(231)

(263)

Invested capital

27,597

28,924

29,220

28,775

30,081

Average invested capital as of September 30, 2024

28,919

 

  

Operating income

1,561

 

  

Income tax expense(3)

(535)

 

  

NOPAT

1,026

 

  

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Adjustments to average invested capital and ROIC

in € M, except where otherwise specified

    

September 30,

    

June 30,

    

March 31,

    

December 31,

    

September 30,

2024

    

2024

    

2024(4)

    

2024(4)

    

2023(4)

    

2023(4)

Total assets

 

 

 

(568)

 

(656)

 

(1,022)

Plus: Cumulative goodwill amortization and impairment loss

(47)

(82)

(84)

Minus: Cash and cash equivalents

 

 

 

16

 

24

 

33

Minus: Deferred tax assets

1

7

13

Minus: Accounts payable to unrelated parties

11

11

18

Minus: Accounts payable to related parties

1

1

1

Minus: Provisions and other current liabilities(2)

 

 

 

20

 

30

 

47

Minus: Income tax liabilities(2)

 

 

 

1

 

3

 

3

Invested capital

 

 

 

(565)

 

(662)

 

(991)

Adjustment to average invested capital as of September 30, 2024

(444)

  

 

 

  

 

  

Adjustment to operating income(4)

54

  

 

  

 

  

 

  

Adjustment to income tax expense(4)

(18)

  

 

  

 

  

 

  

Adjustment to NOPAT

36

  

 

  

 

  

 

  

Reconciliation of average invested capital and ROIC (Non-IFRS Measure)

in € M, except where otherwise specified

    

September 30,

    

June 30,

    

March 31,

    

December 31,

    

September 30,

2024

    

2024

    

2024(4)

    

2024(4)

    

2023(4)

    

2023(4)

Total assets

32,511

 

33,896

 

33,768

 

33,274

 

34,613

Plus: Cumulative goodwill amortization and impairment loss

519

 

565

 

472

 

547

 

619

Minus: Cash and cash equivalents(1)

(1,387)

 

(1,112)

 

(1,176)

 

(1,403)

 

(1,541)

Minus: Deferred tax assets(1)

(296)

(281)

(278)

(285)

(291)

Minus: Accounts payable to unrelated parties(1)

(779)

(793)

(737)

(764)

(744)

Minus: Accounts payable to related parties

(73)

(100)

(109)

(122)

(118)

Minus: Provisions and other current liabilities(2)

(2,671)

(3,062)

(3,006)

(2,906)

(3,188)

Minus: Income tax liabilities(1)

(227)

(189)

(279)

(228)

(260)

Invested capital

27,597

28,924

28,655

28,113

29,090

Average invested capital as of September 30, 2024

28,476

 

  

 

  

 

  

 

Operating income(4)

1,615

 

  

 

  

 

  

 

  

Income tax expense(3), (4)

(553)

 

  

 

  

 

  

 

  

NOPAT

1,062

 

  

 

  

 

  

 

  

ROIC in %

3.7

  

 

  

 

  

 

  

Adjustments to average invested capital and ROIC (excluding Legacy Portfolio Optimization costs)

in € M, except where otherwise specified

    

September 30,

2024

    

2024

Adjustment to operating income

130

Adjustment to income tax expense

56

Adjustment to NOPAT

186

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Reconciliation of average invested capital and ROIC (Non-IFRS Measure, excluding Legacy Portfolio Optimization costs)

in € M, except where otherwise specified

    

September 30,

    

June 30,

    

March 31,

    

December 31,

    

September 30,

2024

2024

2024(4)

2024(4)

2023(4)

2023(4)

Total assets

32,511

33,896

33,768

33,274

34,613

Plus: Cumulative goodwill amortization and impairment loss

519

565

472

547

619

Minus: Cash and cash equivalents(1)

(1,387)

(1,112)

(1,176)

(1,403)

(1,541)

Minus: Deferred tax assets(1)

(296)

(281)

(278)

(285)

(291)

Minus: Accounts payable to unrelated parties(1)

(779)

(793)

(737)

(764)

(744)

Minus: Accounts payable to related parties

(73)

(100)

(109)

(122)

(118)

Minus: Provisions and other current liabilities(2)

(2,671)

(3,062)

(3,006)

(2,906)

(3,188)

Minus: Income tax liabilities(1)

(227)

(189)

(279)

(228)

(260)

Invested capital

27,597

28,924

28,655

28,113

29,090

Average invested capital as of September 30, 2024

28,476

 

  

 

  

 

  

 

  

Operating income(4)

1,745

 

  

 

  

 

  

 

  

Income tax expense(3), (4)

(497)

 

  

 

  

 

  

 

  

NOPAT

1,248

 

  

 

  

 

  

 

  

ROIC in % (excluding Legacy Portfolio Optimization costs)

4.4

  

 

  

 

  

 

  

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

 

  

 

  

 

  

 

  

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FRESENIUS MEDICAL CARE AG

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 2 of the notes to the consolidated financial statements (unaudited) included in this report).
(2) Including non-current provisions, non-current labor expenses and variable payments outstanding for acquisitions and excluding pension liabilities and noncontrolling interests subject to put provisions.
(3) Adjusted for noncontrolling partnership interests.
(4) Including adjustments for acquisitions and divestitures made during the last twelve months with a purchase price above a €50 M threshold.

Net cash provided by (used in) operating activities in % of revenue

Our consolidated statement of cash flows indicates how we generated and used cash and cash equivalents. In conjunction with our other primary interim financial statements, it provides information that helps us evaluate changes to our net assets and our financial structure (including liquidity and solvency). Net cash provided by (used in) operating activities is applied to assess whether a business can internally generate the cash required to make the necessary replacement and expansion of investments. This indicator is impacted by the profitability of our business and the development of working capital, mainly receivables. Net cash provided by (used in) operating activities in percent of revenue shows the percentage of our revenue that is available in terms of financial resources. This measure is an indicator of our operating financial strength.

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FRESENIUS MEDICAL CARE AG

Free cash flow in % of revenue (Non-IFRS Measure)

Free cash flow (which we define as net cash provided by (used in) operating activities after capital expenditures, before acquisitions and investments) refers to the cash flow we have at our disposal, including cash flows that may be restricted for other uses. 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.

For a reconciliation of cash flow performance indicators for the nine months ended September 30, 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 “III. Results of operations, financial position and net assets - Financial position - Sources of Liquidity.”

Net leverage ratio (Non-IFRS Measure)

The net leverage ratio is a performance indicator used for capital management. 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 last twelve months with a purchase price above a €50 M threshold as defined in our €2 billion sustainability-linked syndicated revolving credit facility (Syndicated Credit Facility) (see note 8 of the notes to the consolidated financial statements (unaudited) included in this report),
non-cash charges,
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. (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 the review of our business portfolio, mainly due to exiting unsustainable markets and divesting non-core businesses, as well as the cessation of certain R&D programs to enable more focused capital allocation towards areas in our core business that are expected to have higher profitable growth (Legacy Portfolio Optimization). During the nine months ended September 30, 2024, these impacts are mainly driven by impairment losses resulting from the measurement of assets held for sale (see note 2 of the notes to the consolidated financial statements (unaudited) included in this report) as well as gains and losses from divestitures.

The ratio is an indicator of the length of time the Company needs to service the net debt out of its own resources. We believe that the net leverage ratio provides alternative information that management believes to be useful in assessing our ability to meet our payment obligations in addition to considering the absolute amount of our debt. We have a strong market position in a growing, global and mainly non-cyclical market. Furthermore, most of our customers have a high credit rating as the dialysis industry is characterized by stable and sustained cash flows. We believe this enables us to work with a reasonable proportion of debt.

Adjusted EBITDA, a non-IFRS Measure, is used in our capital management and is also relevant in major financing instruments, including the Syndicated Credit Facility. You should not consider adjusted EBITDA to be an alternative to net earnings determined in accordance with IFRS Accounting Standards or to cash flow from operations, investing activities or financing activities. 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 our self-set target range for the net leverage ratio and a reconciliation of adjusted EBITDA and net leverage ratio as of September 30, 2024 and December 31, 2023, see “III. Results of operations, financial position and net assets - Financial position - Sources of Liquidity.”

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FRESENIUS MEDICAL CARE AG

III. 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 three and nine months ended September 30, 2024:

Legacy Portfolio Optimization

As noted above, we are reviewing 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. During the three and nine months ended September 30, 2024, the impacts from Legacy Portfolio Optimization mainly comprise the items described in iv., above, under “Net leverage ratio (Non-IFRS Measure)” (see note 2 of the notes to the consolidated financial statements (unaudited) included in this report).

Overall, the impacts from Legacy Portfolio Optimization resulted in a positive effect on operating income of €17 M and a negative effect on operating income €141 M for the three and nine months ended September 30, 2024, respectively (negative effect of €53 M and €147 M for the three and nine months ended September 30, 2023, respectively).

FME25 Program

Overall, the costs related to the FME25 Program resulted in a negative impact to operating income of €39 M and €107 M for the three and nine months ended September 30, 2024 (€49 M and €100 M for the three and nine months ended September 30, 2023, respectively). For the three and nine months ended September 30, 2024, recurring savings related to the FME25 Program were €161 M and €405 M, respectively (€97 M and €232 M for the three and nine months ended September 30, 2023, respectively).

In the discussion of our results for the three and nine months ended September 30, 2024 compared to the three and nine months ended September 30, 2023 below, the effects of the costs and savings related to the FME25 Program are presented on a net basis.

Third-party Cyber Incident

On February 21, 2024, one of our third party service providers was subject to a cyber-attack leading to the shutdown of its systems (the Third-party Cyber Incident). As this third party provided us with a range of financial clearinghouse services, the cyber-attack on its systems led to delays in claim processing impacting our consolidated financial statements, primarily affecting accounts receivable balances and cash flows. As of September 30, 2024, the impacts related to the Third-party Cyber Incident have been substantially resolved and are no longer material. See note 1 of the notes to the consolidated financial statements (unaudited) included in this report for further information.

Other Trends

We continue to face significant challenges in the labor market, resulting in meaningfully higher costs. While we have seen signs of a stabilization of the labor market, such challenges are expected to continue in 2024 as we make investments in our employees. Additionally, overall treatments decreased for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 primarily as divestitures in connection with Legacy Portfolio Optimization had a negative impact on overall treatment numbers. Specifically in the U.S., volumes were negatively affected by the cancellation of less profitable acute care contracts contributing to a 0.2% decline in Same Market Treatment Growth (as defined below) for both the for the three- and nine-month periods ended September 30, 2024 in addition to the impacts from divestitures noted above, as indicated in the discussion of our consolidated revenue and operating segment results and in the tables under “Key Performance Indicators,” below.

The following sections summarize our consolidated results of operations, financial position and net assets as well as key performance indicators by reporting segment, as well as Corporate, for the periods indicated. We prepared the information consistent with the manner in which management internally disaggregates financial information to assist in making operating decisions and evaluating management performance.

Results of operations

Revenue and operating income generated in countries outside the eurozone are subject to currency fluctuations. 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.

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FRESENIUS MEDICAL CARE AG

Three months ended September 30, 2024 compared to three months ended September 30, 2023

Results of operations

in € M

    

    

Change in %

For the three months ended

    

Currency

    

September 30,

translation

Constant

    

2024

    

2023

    

As reported

    

effects

    

Currency(1)

Revenue

 

4,760

4,936

(4)

(2)

(2)

Costs of revenue

(3,614)

(3,707)

(3)

2

(1)

Selling, general and administrative expense

 

(756)

(794)

(5)

1

(4)

Research and development

 

(40)

(53)

(24)

0

(24)

Income from equity method investees

 

41

23

82

0

82

Other operating income

191

65

196

(1)

197

Other operating expense

(119)

(146)

(18)

5

(13)

Operating income

463

324

43

0

43

Operating income margin

9.7

6.6

Interest income

17

25

(33)

(4)

(29)

Interest expense

(99)

(114)

(13)

1

(12)

Income tax expense

(117)

(88)

32

(3)

29

Net income

264

147

80

(1)

81

Net income attributable to noncontrolling interests

(51)

(63)

(19)

1

(18)

Net income attributable to shareholders of FME AG

213

84

153

(2)

155

Basic and diluted earnings per share in €

0.73

0.29

153

(2)

155

(1) For further information on Constant Exchange Rates, see “II. Discussion of measures – Non–IFRS measures” above.

Key Performance Indicators

The following discussions include our two operating and reportable segments and the measures we use to manage these segments. For further information, see note 13 of the notes to the consolidated financial statements (unaudited) included in this report.

Revenue

in € M, except dialysis treatment, patient and clinic data

Change in %

For the three months ended

Currency

Same Market

September 30,

translation

Constant

Organic

Treatment

2024

2023

As reported

effects

Currency(1)

growth

Growth(2)

    

    

    

    

    

    

    

Revenue

4,760

4,936

(4)

(2)

(2)

2

Care Delivery segment

3,770

3,974

(5)

(1)

(4)

1

1.0

Thereof: U.S.

3,180

3,221

(1)

(1)

0

0

0.0

Thereof: International

590

753

(22)

(1)

(21)

4

2.9

Care Enablement segment

1,359

1,330

2

(2)

4

4

Inter-segment eliminations

(369)

(368)

0

(1)

1

Dialysis treatments

11,830,895

12,994,191

(9)

Patients

308,216

341,793

(10)

Clinics

3,732

4,014

(7)

(1) For further information on Constant Exchange Rates, see “II. Discussion of measures – Non–IFRS measures” above.

(2)

Same market treatment growth represents growth in treatments, adjusted for certain reconciling items including (but not limited to) treatments from acquisitions, closed or sold clinics and differences in dialysis days (Same Market Treatment Growth).

Consolidated

Revenue decreased as compared to the three months ended September 30, 2023 primarily driven by the effect of closed or sold operations (primarily related to Legacy Portfolio Optimization) and a negative impact from foreign currency translation, partially offset by an increase in organic growth in both Care Delivery and Care Enablement.

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Care Delivery

The decrease in Care Delivery revenue as compared to the three months ended September 30, 2023 was driven by the effect of closed or sold operations (primarily related to Legacy Portfolio Optimization) and a negative impact from foreign currency translation, partially offset by an increase in organic growth. Organic growth was supported by Value and Risk-Based Care Programs, reimbursement rate increases and a favorable payor mix, partially offset by implicit price concessions. As of September 30, 2024, the number of patients treated in dialysis clinics that we own or operate in Care Delivery decreased as compared to September 30, 2023, primarily driven by divestitures in connection with Legacy Portfolio Optimization. Treatments in our Care Delivery segment decreased as compared to the three months ended September 30, 2023, primarily due to the effect of closed or sold clinics (primarily related to Legacy Portfolio Optimization), partially offset by Same Market Treatment Growth. During the three months ended September 30, 2024, we opened 9 dialysis clinics and combined, closed or sold 34 clinics.

U.S.

In the U.S., the decrease in revenue was driven by the effect of closed or sold operations (primarily related to Legacy Portfolio Optimization) and a negative impact from foreign currency translation, partially offset by an increase in dialysis days. Organic growth in the U.S. was supported by Value and Risk-Based Care Programs, an overall increase in treatment volumes, reimbursement rate increases and a favorable payor mix, partially offset by increased implicit price concessions. In the U.S., the number of patients treated in dialysis clinics that we own or operate slightly increased to 205,942 patients (September 30, 2023: 205,887). Treatments increased slightly to 7,886,577 for the three months ended September 30, 2024 as compared to 7,855,731 for the three months ended September 30, 2023 as Same Market Treatment Growth was limited by the cancellation of less profitable acute care contracts (-0.2%). We owned or operated 2,629 dialysis clinics in the U.S. at September 30, 2024 as compared to 2,617 dialysis clinics at September 30, 2023. During the three months ended September 30, 2024, we opened 6 dialysis clinics and combined, closed or sold 5 clinics.

International

In our operations outside the U.S. (International), the decrease in revenue was driven by the effect of closed or sold operations (primarily related to Legacy Portfolio Optimization) and a negative impact from foreign currency translation, partially offset by an increase in organic growth. There were 102,274 patients, a decrease of 25% (September 30, 2023: 135,906) treated in dialysis clinics that we own or operate in International, primarily driven by divestitures in connection with Legacy Portfolio Optimization. Treatments in International decreased by 23% to 3,944,318 for the three months ended September 30, 2024 as compared to 5,138,460 for the three months ended September 30, 2023 driven by the effect of closed or sold clinics (primarily related to Legacy Portfolio Optimization), partially offset by an increase in Same Market Treatment Growth. We owned or operated 1,103 dialysis clinics in International at September 30, 2024 as compared to 1,397 dialysis clinics at September 30, 2023. During the three months ended September 30, 2024, we opened 3 dialysis clinics and combined, closed or sold 29 clinics.

Care Enablement

Care Enablement revenue increased as compared to the three months ended September 30, 2023 primarily driven by higher revenues related to in-center disposables, products for acute care treatments, home hemodialysis products, and acute cardiopulmonary products, partially offset by a negative impact from foreign currency translation. The development was mainly driven by an increase in sales volumes for our products across all of our geographical regions. Pricing momentum outside of China remained positive. In China, pricing was negatively impacted by the rollout of volume-based procurement.

Operating income (loss)

in € M

Change in %

For the three months ended

Currency

September 30,

translation

Constant

2024

2023

As reported

effects

Currency(1)

    

    

    

 

    

    

Operating income (loss)

463

324

43

0

43

Care Delivery segment

419

332

26

(1)

27

Care Enablement segment

61

(1)

n.a.

n.a.

Inter-segment eliminations

(4)

1

n.a.

n.a.

Corporate

(13)

(8)

67

(17)

84

Operating income (loss) margin

9.7

6.6

Care Delivery segment

11.1

8.4

Care Enablement segment

4.5

(0.1)

(1)

For further information on Constant Exchange Rates, see “II. Discussion of measures – Non–IFRS measures” above.

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Consolidated

The increase in our operating income was largely driven by a positive impact from business growth, a favorable impact from net savings associated with the FME25 Program, a positive impact from Legacy Portfolio Optimization and a favorable impact from the phasing of income attributable to a consent agreement on certain pharmaceuticals, partially offset by higher personnel expense, a negative impact from Value and Risk-Based Care Programs, an unfavorable impact from foreign currency transaction effects, an unfavorable impact from the valuation of vPPAs and inflationary cost increases.

Care Delivery

Care Delivery operating income increased primarily as a result of a positive impact from Legacy Portfolio Optimization, a positive impact from business growth and a favorable impact from the phasing of income attributable to a consent agreement on certain pharmaceuticals, partially offset by higher personnel expense and a negative impact from Value and Risk-Based Care Programs.

Care Enablement

Care Enablement operating income increased primarily due to a favorable impact from net savings from the FME25 Program and a positive impact from business growth (driven by positive volume and pricing developments which were partially offset by the rollout of volume-based procurement in China), partially offset by inflationary cost increases and an unfavorable impact from foreign currency transaction effects.

Secondary performance indicators and other contributors to profit and loss

Costs of revenue decreased as compared to the three months ended September 30, 2023, primarily driven by the absence, in 2024, of the results of operations for businesses previously divested under Legacy Portfolio Optimization, lower costs associated with business growth, a positive impact from foreign currency translation and net savings from the FME25 Program, partially offset by increased Value and Risk-Based Care Programs expenses (primarily related to higher memberships), higher personnel expense and inflationary cost increases.

Selling, general and administrative (SG&A) expense decreased for the three months ended September 30, 2024 as compared to three months ended September 30, 2023, primarily driven by net savings from the FME25 Program.

The decrease in research and development expense was largely driven by lower personnel costs for R&D projects and higher capitalization of development costs, partially offset by increased R&D activity.

The increase in income from equity method investees was primarily driven by higher earnings attributable to VFMCRP.

The increase in other operating income was primarily driven by a favorable impact from the phasing of income attributable to a consent agreement on certain pharmaceuticals, higher foreign exchange gains, a positive impact from Humacyte Remeasurements and favorable impacts from Legacy Portfolio Optimization.

The decrease in other operating expense was primarily driven by favorable impacts from Legacy Portfolio Optimization and the absence, in 2024, of the results of operations for businesses previously divested under Legacy Portfolio Optimization, partially offset by higher foreign exchange losses and an unfavorable impact from the valuation of vPPAs.

Net interest expense decreased by 7% to €82 M from €89 M, primarily due to favorable effects from foreign exchange forward contracts and refinancing activities, partially offset by lower interest income associated with receivables related to a royalty stream that we are entitled to base on sales made by Humacyte, Inc. in the U.S. and a negative impact from the Third-party Cyber Incident.

The effective tax rate decreased to 30.6% from 37.6% for the same period of 2023, largely driven by lower tax provisions related to the release of certain valuation allowances and tax law changes, partially offset by a negative impact from Legacy Portfolio Optimization and a lower portion of tax-free income attributable to noncontrolling interests compared to income before income taxes.

Net income attributable to noncontrolling interests decreased for the three months ended September 30, 2024 as compared to the three months ended September 30, 2023, primarily driven by lower earnings in entities in which we have less than 100% ownership, partially offset by a favorable impact from Legacy Portfolio Optimization and a positive impact from foreign currency translation.

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 for the three months ended September 30, 2024 as compared to the three months ended September 30, 2023, due to the increase in net income attributable to shareholders of FME AG described above. The average weighted number of shares outstanding for the period was unchanged at 293.4 M on September 30, 2024 as compared to the prior year period.

We employed 113,079 people (total headcount) as of September 30, 2024 (September 30, 2023: 123,106). This 8% decrease was largely due to the divestiture of certain businesses in connection with Legacy Portfolio Optimization.

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FRESENIUS MEDICAL CARE AG

Nine months ended September 30, 2024 compared to nine months ended September 30, 2023

Results of operations

in € M

    

    

    

    

    

Change in %

For the nine months ended

Currency

September 30,

translation

Constant

    

2024

    

2023

    

As reported

    

effects

    

Currency(1)

Revenue

14,251

14,466

(1)

0

(1)

Costs of revenue

(10,765)

(10,890)

(1)

1

0

Selling, general and administrative expense

(2,303)

(2,351)

(2)

1

(1)

Research and development

(133)

(166)

(20)

0

(20)

Income from equity method investees

103

98

4

0

4

Other operating income

532

258

106

(1)

107

Other operating expense

(552)

(473)

17

1

18

Operating income

1,133

942

20

(1)

21

Operating income margin

8.0

6.5

Interest income

50

61

(18)

(3)

(15)

Interest expense

(306)

(313)

(2)

1

(1)

Income tax expense

(255)

(214)

19

1

20

Net income

622

476

31

(1)

32

Net income attributable to noncontrolling interests

(151)

(165)

(8)

1

(7)

Net income attributable to shareholders of FME AG

471

311

51

(2)

53

Basic and diluted earnings per share in €

1.61

1.06

51

(2)

53

(1)For further information on Constant Exchange Rates, see “II. Discussion of measures – Non–IFRS measures” above.

Key Performance Indicators

The following discussions include our two operating and reportable segments and the measures we use to manage these segments. For further information, see note 13 of the notes to the consolidated financial statements (unaudited) included in this report.

Revenue

in € M, except dialysis treatment data

    

    

    

    

Change in %

    

    

    

    

    

Same

For the nine months ended

Currency 

Market

September 30,

As

translation

Constant

Organic

Treatment

    

2024

    

2023

    

reported

 effects

Currency(1)

growth

Growth(2)

Revenue

14,251

14,466

(1)

0

(1)

3

Care Delivery segment

11,330

11,602

(2)

0

(2)

3

0.4

Thereof: U.S.

9,439

9,344

1

0

1

3

(0.3)

Thereof: International

1,891

2,258

(16)

(2)

(14)

3

2.0

Care Enablement segment

4,020

3,965

1

(2)

3

3

Inter-segment eliminations

(1,099)

(1,101)

0

0

0

 

  

 

  

Dialysis treatments

35,950,704

38,807,179

(7)

 

  

 

  

 

  

 

  

(1)For further information on Constant Exchange Rates, see “II. Discussion of measures – Non–IFRS measures” above.

(2)

Same market treatment growth represents growth in treatments, adjusted for certain reconciling items including (but not limited to) treatments from acquisitions, closed or sold clinics and differences in dialysis days (Same Market Treatment Growth).

Consolidated

Revenue decreased as compared to the nine months ended September 30, 2023 primarily driven by the effect of closed or sold operations (primarily related to Legacy Portfolio Optimization) partially offset by an increase in organic growth in both Care Delivery and Care Enablement.

Care Delivery

The decrease in Care Delivery revenue as compared to the nine months ended September 30, 2023 was driven by the effect of closed or sold operations (primarily related to Legacy Portfolio Optimization), partially offset by an increase in organic growth. 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. Treatments in our Care Delivery segment decreased for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 mainly due to the effect of closed or sold clinics (primarily related to Legacy Portfolio Optimization), partially offset by an increase in dialysis days.

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U.S.

In the U.S., the increase in revenue was driven by an increase in organic growth, partially offset by the effect of closed or sold operations (primarily related to Legacy Portfolio Optimization). Organic growth in the U.S. was supported by Value and Risk-Based Care Programs, reimbursement rate increases and a favorable payor mix, partially offset by increased implicit price concessions. In the U.S., treatments remained relatively stable at 23,299,461 for the nine months ended September 30, 2024 as compared to 23,380,747 for the nine months ended September 30, 2023 primarily as Same Market Treatment Growth was limited by the cancellation of less profitable acute care contracts (-0.2%).

International

In International, the decrease in revenue was driven by the effect of closed or sold operations (primarily related to Legacy Portfolio Optimization) and a negative impact from foreign currency translation, partially offset by an increase in organic growth and an increase in dialysis days. Treatments in International decreased by 18% to 12,651,243 for the nine months ended September 30, 2024 as compared to 15,426,432 for the nine months ended September 30, 2023 driven by the effect of closed or sold operations (primarily related to Legacy Portfolio Optimization), partially offset by an increase in Same Market Treatment Growth.

Care Enablement

Care Enablement revenue increased as compared to the nine months ended September 30, 2023 primarily driven by higher revenues related to in-center disposables, home hemodialysis products, products for acute care treatments and machines for chronic treatment, partially offset by a negative impact from foreign currency translation and lower sales of peritoneal dialysis products. The development was driven by volume increases for our products across all of our geographical regions. Additionally, pricing momentum outside of China remained positive. In China, pricing was negatively impacted by the rollout of volume-based procurement.

Operating income (loss)

in € M

Change in %

For the nine months ended 

Currency

September 30,

translation

Constant

    

2024

    

2023

    

As reported

    

effects

    

Currency(1)

Operating income (loss)

1,133

942

20

(1)

21

Care Delivery segment

937

1,001

(6)

0

(6)

Care Enablement segment

196

(24)

n.a.

n.a.

Inter-segment eliminations

(9)

(12)

(26)

(11)

(37)

Corporate

9

(23)

n.a.

 

n.a.

Operating income (loss) margin

8.0

6.5

 

  

 

  

 

  

Care Delivery segment

8.3

8.6

 

  

 

  

 

  

Care Enablement segment

4.9

(0.6)

 

  

 

  

 

  

(1) For further information on Constant Exchange Rates, see “II. Discussion of measures – Non–IFRS measures” above.

Consolidated

The increase in our operating income was largely driven by a positive impact from business growth, net savings associated with the FME25 Program, a positive impact from Humacyte Remeasurements and a favorable impact from the phasing of income attributable to a consent agreement on certain pharmaceuticals, partially offset by higher personnel expense, inflationary cost increases, unfavorable foreign currency transaction effects and an unfavorable impact from the valuation of vPPAs.

Care Delivery

Care Delivery operating income decreased primarily as a result of higher personnel expense, Legacy Portfolio Optimization, inflationary cost increases and the absence, in 2024, of the results of operations for businesses previously divested under Legacy Portfolio Optimization, partially offset by a positive impact from business growth,  a favorable impact from the phasing of income attributable to a consent agreement on certain pharmaceuticals and net savings associated with the FME25 Program.

Care Enablement

For the nine months ended September 30, 2024, Care Enablement recorded operating income as compared to an operating loss for the nine months ended September 30, 2023, primarily due to net savings from the FME25 Program, a favorable impact from Legacy Portfolio Optimization, business growth (driven by positive volume and pricing developments which were partially offset by the rollout of volume-based procurement in China) and a positive impact from Humacyte Remeasurements, partially offset by inflationary cost increases and unfavorable foreign currency transaction effects.

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Secondary performance indicators and other contributors to profit and loss

Costs of revenue decreased as compared to the nine months ended September 30, 2023 primarily due to lower costs associated with business growth, the absence, in 2024, of the results of operations for businesses previously divested under Legacy Portfolio Optimization, net savings from the FME25 Program and a positive impact from foreign currency translation, partially offset by increased Value and Risk-Based Care Programs expenses (primarily related to higher memberships), higher personnel expense and inflationary cost increases.

SG&A expense decreased for the nine months ended September 30, 2024 as compared to the prior year comparable period driven by net savings from the FME25 Program.

The decrease in research and development expense for the nine months ended September 30, 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 increase in income from equity method investees was primarily driven by higher earnings attributable to VFMCRP.

The increase in other operating income was primarily driven by the impacts from Legacy Portfolio Optimization, a positive impact from Humacyte Remeasurements and a favorable impact from the phasing of income attributable to a consent agreement on certain pharmaceuticals.

The increase in other operating expense was primarily driven by the impacts from Legacy Portfolio Optimization and an unfavorable impact from the valuation of vPPAs, partially offset by the absence, in 2024, of the results of operations for businesses previously divested under Legacy Portfolio Optimization.

Net interest expense increased by 2% to €256 M from €252 M, primarily due to lower interest income associated with receivables related to a royalty stream that we are entitled to base on sales made by Humacyte, Inc. in the U.S and a negative impact from the Third-party Cyber Incident, partially offset by favorable effects from foreign exchange forward contracts.

The effective tax rate decreased to 29.1% from 31.0% for the same period of 2023 primarily driven by lower tax provisions related to the release of certain valuation allowances and tax law changes, partially offset by a negative impact from Legacy Portfolio Optimization and a lower portion of tax-free income attributable to noncontrolling interests compared to income before income taxes.

Net income attributable to noncontrolling interests decreased for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 primarily due to lower earnings in entities in which we have less than 100% ownership and a negative impact from foreign currency translation, partially offset by a favorable impact from Legacy Portfolio Optimization.

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 for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 due to the increase in net income attributable to shareholders of FME AG described above. The average weighted number of shares outstanding for the period was unchanged at 293.4 M on September 30, 2024 as compared to the prior year period.

Financial position

Sources of liquidity

Our primary sources of liquidity are typically cash provided by operating activities, cash provided by short-term debt, proceeds from the issuance of long-term debt and divestitures. 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.

As of September 30, 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 8 of the notes to the consolidated financial statements (unaudited) included in this report).

In our long-term capital management, we focus primarily on the net leverage ratio, a Non-IFRS measure, see “II. Discussion of measures – Non–IFRS measures – Net leverage ratio (Non-IFRS Measure),” above. Our self-set target for the net leverage ratio is 3.0 - 3.5x, which management considers appropriate for the Company. The following table shows the reconciliation of net debt and adjusted EBITDA and the calculation of the net leverage ratio as of September 30, 2024 and December 31, 2023.

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Reconciliation of adjusted EBITDA and net leverage ratio to the most directly comparable IFRS® financial measure

in € M, except for net leverage ratio

    

September 30,

    

December 31,

2024

2023

Debt and lease liabilities(1)

11,218

12,187

Minus: Cash and cash equivalents(2)

(1,387)

(1,427)

Net debt

9,831

10,760

Net income(3)

879

732

Income tax expense(3)

342

301

Interest income(3)

(77)

(88)

Interest expense(3)

417

424

Depreciation and amortization(3)

1,546

1,613

Adjustments(3), (4)

344

409

Adjusted EBITDA

3,451

3,391

Net leverage ratio

2.8

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.

(2)

Includes cash and cash equivalents included within assets held for sale (see note 2 of the notes to the consolidated financial statements (unaudited) included in this report).

(3)

Last twelve months.

(4)

Acquisitions and divestitures made for the last twelve months with a purchase price above a €50 M threshold as defined in the Syndicated Credit Facility (2024: -€32 M; 2023: -€35 M), non-cash charges, primarily related to pension expense (2024: €58 M; 2023: €56 M), impairment loss (2024: €145 M; 2023: €139 M) and special items, including costs related to the FME25 Program (2024: €127 M; 2023: €106 M), Legal Form Conversion Costs (2024: €22 M; 2023: €30 M), Legacy Portfolio Optimization (2024: €101 M; 2023: €128 M) and Humacyte Remeasurements (2024: -€77 M; 2023: -€15 M). See “II. Discussion of measures — Non-IFRS measures — Net leverage ratio (Non-IFRS Measure),” above.

At September 30, 2024, we had cash and cash equivalents of €1,371 M (December 31, 2023: €1,403 M).

Free cash flow (Net cash provided by (used in) operating activities, after capital expenditures, before acquisitions and investments) is a Non-IFRS Measure and is reconciled to net cash provided by (used in) operating activities, the most directly comparable IFRS Accounting Standards measure, see “II. Discussion of measures – Non–IFRS measures – Net cash provided by (used in) operating activities in % of revenue” and “– Free cash flow in % of revenue (Non-IFRS Measure)” above.

The following table shows the cash flow performance indicators for the nine months ended September 30, 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

For the nine months ended 

September 30,

    

2024

    

2023

Revenue

14,251

14,466

Net cash provided by (used in) operating activities

1,554

1,910

Capital expenditures

(459)

(434)

Proceeds from sale of property, plant and equipment

7

4

Capital expenditures, net

(452)

(430)

Free cash flow

1,102

1,480

Net cash provided by (used in) operating activities in % of revenue

10.9

13.2

Free cash flow in % of revenue

7.7

10.2

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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 decrease in net cash provided by operating activities in percent of revenue as compared to the first nine months of 2023 was driven by a negative impact from the phasing of dividend payments received from equity method investments as well as income tax payments for current and prior year periods (particularly in the U.S.). Delays in collections of trade accounts receivable from unrelated parties have been partially mitigated by the substantial resolution of the impacts related to the Third-party Cyber Incident as of September 30, 2024.

The profitability of our business depends significantly on reimbursement rates for our services. For the nine months ended September 30, 2024, approximately 79% 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. For the nine months ended September 30, 2024, approximately 26% of our consolidated revenue was attributable to reimbursements from U.S. federal health care benefit programs such as Medicare and Medicaid. Legislative changes could affect Medicare reimbursement rates for a significant portion of the services we provide as well as the scope of Medicare coverage. A decrease in reimbursement rates or the scope of coverage could have a material adverse effect on our business, financial position and results of operations and thus on our capacity to generate cash flow. See “— Forward-looking statements” and “I. 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 7 of the notes to the consolidated financial statements (unaudited) included in this report) as well as from the use of our bilateral credit lines. We expect that we will have adequate sources of financing available to us. Our Syndicated Credit Facility is also available for backup financing needs. In addition, to finance acquisitions or meet other needs, we expect to utilize long-term financing arrangements, such as the issuance of bonds (see “Net cash provided by (used in) financing activities,” below).

Net cash provided by (used in) operating activities depends on the collection of accounts receivable. Commercial customers and government institutions generally have different payment cycles. Lengthening their payment cycles could have a material adverse effect on our capacity to generate cash flow. In addition, we could face difficulties enforcing and collecting accounts receivable under the legal systems of, and due to the economic conditions in, some countries. Accounts receivable balances, net of expected credit losses, represented Days Sales Outstanding (DSO) (Non-IFRS Measure) of 65 days at September 30, 2024 (December 31, 2023: 67 days).

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. 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 September 30, 2024 are adjusted for an increase in the amount of €67.1 M and €0.8 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. Additionally, daily revenues in the amount of €(0.6) M and €(0.4) M for the twelve months ended September 30, 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 “II. Discussion of measures — Non-IFRS measures — Net leverage ratio (Non-IFRS Measure)” above) and in the amount of €0.9 M and €0.9 M for the twelve months ended September 30, 2024 and December 31, 2023, respectively to include sales or value-added tax and other smaller effects.

The development of DSO by reporting segment is shown in the table below:

Development of days sales outstanding

in days

    

September 30,

    

December 31,

    

    

2024

    

2023

    

Explanation of movement

Care Delivery

57

59

A positive effect from Legacy Portfolio Optimization

Care Enablement

94

97

Improvement of payment collections in certain geographical regions

FME AG

65

67

 

  

Due to the fact that a large portion of our reimbursement is provided by public health care organizations and private payors, we expect that most of our accounts receivable will be collectible.

For information regarding litigation exposure as well as ongoing and future tax audits, see note 11 of the notes to the consolidated financial statements (unaudited) included in this report.

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Net cash provided by (used in) investing activities

Net cash provided by investing activities in the first nine months of 2024 was €34 M as compared to net cash used in investing activities of €448 M in the comparable period of 2023. The following table shows a breakdown of our investing activities for the first nine months of 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

For the nine months ended September 30,

    

2024

    

2023

    

2024

    

2023

    

2024

    

2023

Care Delivery

233

229

26

60

527

63

Care Enablement

219

201

57

59

42

38

Total

452

430

83

119

569

101

The majority of our capital expenditures in the first nine months of 2024 was used for maintaining existing clinics and centers, capitalization of machines provided to our customers, expansion of production capacity, capitalization of certain development costs and equipping new clinics and centers. Capital expenditures accounted for approximately 3% of total revenue in the first nine months of 2024 and 2023.

Investments in the first nine months of 2024 were primarily comprised of purchases of debt securities and equity investments. Divestitures in the first nine months of 2024 were mainly related to the divestment of equity investments (including divestitures under our Legacy Portfolio Optimization program) and debt securities.

Investments in the first nine months of 2023 were primarily comprised of purchases of debt securities. Divestitures in the first nine months of 2023 were mainly related to the divestment of debt securities and equity investments as well as clinics and centers. Acquisitions in the first nine months of 2023 related primarily to the purchase of dialysis clinics.

In 2024, we anticipate capital expenditures around €0.8 billion and expect to limit acquisition and investment spending, while focusing on the organic growth of our business. Our anticipated capital expenditures are driven by the need to position us well to capture growth opportunities as well as to maintain quality levels and patient experience. Additionally, we plan accelerated capital expenditures in new production facilities as well as into R&D activities for a more globalized product portfolio.

Net cash provided by (used in) financing activities

In the first nine months of 2024, net cash used in financing activities was €1,604 M as compared to net cash used in financing activities of €1,113 M in the first nine months of 2023.

In the first nine months of 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, partially offset by proceeds from short and long-term debt.

In the first nine months of 2023, cash was mainly used in the repayment of lease liabilities (including lease liabilities from related parties), the repayment of short-term debt (including borrowings under our commercial paper program and short-term debt from related parties), the payment of dividends and distributions to noncontrolling interests, partially offset by proceeds from short-term debt (including borrowings under our commercial paper program and short-term debt from related parties) and long-term debt.

For further information, see note 8 of the notes to the consolidated financial statements (unaudited) included in this report.

On May 22, 2024, we paid a dividend with respect to 2023 of €1.19 per share (for 2022 paid in 2023 €1.12 per share). The total dividend payment was €349 M as compared to €329 M in the prior year.

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Balance sheet structure

Total assets as of September 30, 2024 decreased to €32.5 billion as compared to €33.9 billion at December 31, 2023. Apart from a 1% negative impact resulting from foreign currency translation, total assets decreased to €32.9 billion primarily due to a decrease in assets classified as held for sale as a result of divestitures in connection with Legacy Portfolio Optimization, goodwill, property, plant and equipment and trade accounts and other receivables from unrelated parties.

Current assets as a percent of total assets decreased to 25% as of September 30, 2024 as compared to 26% at December 31, 2023, primarily as a result of a decrease in assets classified as held for sale as a result of divestitures in connection with Legacy Portfolio Optimization and a decrease in trade accounts and other receivables from unrelated parties, partially offset by a decrease in non-current assets primarily as a result of divestitures and asset held for sale classification in connection with Legacy Portfolio Optimization. The equity ratio, the ratio of our equity divided by total liabilities and shareholders’ equity, increased to 45% at September 30, 2024 as compared to 44% at December 31, 2023, primarily driven by a decrease in debt. ROIC increased to 3.7% at September 30, 2024 as compared to 2.8% at December 31, 2023, primarily driven by an increase in operating income over the last twelve months, including adjustments for acquisitions and divestitures made during the last twelve months with a purchase price above a €50 M threshold. ROIC excluding Legacy Portfolio Optimization costs was 4.4% at September 30, 2024. 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 7.5%. For further information on ROIC, see “II. Discussion of measures – Non–IFRS measures – Return on invested capital (ROIC) (Non-IFRS Measure)” above.

Report on post-balance sheet date events

Refer to note 14 of the notes to the consolidated financial statements (unaudited) included in this report.

Recently issued accounting standards

Refer to note 1 of the notes to the consolidated financial statements (unaudited) included in this report for information regarding recently issued accounting standards.

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Interim Financial Statements

Consolidated statements of income

(unaudited)

Consolidated statements of income

in € thousands (THOUS), except per share data

For the three months

For the nine months

ended September 30, 

ended September 30, 

    

Note

    

2024

    

2023

    

2024

    

2023

Revenue:

Health care services

 

3a

3,722,574

3,927,369

11,192,976

11,468,728

Health care products

 

3a

1,037,588

1,008,868

3,058,146

2,997,003

 

4,760,162

4,936,237

14,251,122

14,465,731

Costs of revenue:

 

Health care services

 

3,015,741

3,102,946

9,034,799

9,161,769

Health care products

 

598,337

604,294

1,730,099

1,728,612

3,614,078

3,707,240

10,764,898

10,890,381

Operating (income) expenses:

 

Selling, general and administrative

 

3b

756,146

793,790

2,303,256

2,351,179

Research and development

 

3c

40,047

53,041

133,433

165,985

Income from equity method investees

 

13

(41,248)

(22,635)

(102,730)

(98,419)

Other operating income

3d

(191,066)

(64,612)

(532,494)

(257,913)

Other operating expense

3d

119,509

145,185

551,261

472,726

Operating income

 

462,696

324,228

1,133,498

941,792

Other (income) expense:

 

Interest income

 

(16,934)

(25,140)

(50,342)

(61,351)

Interest expense

 

99,104

113,857

306,030

313,183

Income before income taxes

 

380,526

235,511

877,810

689,960

Income tax expense

 

116,534

88,450

255,058

214,100

Net income

 

263,992

147,061

622,752

475,860

Net income attributable to noncontrolling interests

 

50,965

62,710

151,738

164,788

Net income attributable to shareholders of FME AG

 

213,027

84,351

471,014

311,072

Basic earnings per share

 

3e

0.73

0.29

1.61

1.06

Diluted earnings per share

 

3e

0.73

0.29

1.61

1.06

See accompanying notes to the interim consolidated financial statements (unaudited).

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Consolidated statements of comprehensive income

(unaudited)

Consolidated statements of comprehensive income

in € THOUS

For the three months

For the nine months

ended September 30, 

ended September 30, 

    

2024

    

2023

    

2024

    

2023

Net income

263,992

147,061

622,752

475,860

Other comprehensive income (loss):

Components that will not be reclassified to profit or loss:

FVOCI equity investments

(4,273)

13,647

Actuarial gain (loss) on defined benefit pension plans

(31,671)

48,267

17,547

32,475

Income tax (expense) benefit related to components of other comprehensive income not reclassified

9,656

(14,445)

(4,694)

(9,537)

(22,015)

33,822

8,580

36,585

Components that may be reclassified subsequently to profit or loss:

Gain (loss) related to foreign currency translation

(560,649)

367,067

(194,220)

(57,236)

FVOCI debt securities

9,544

(6,809)

7,334

(3,523)

Gain (loss) related to cash flow hedges

9,364

(9,901)

2,152

(6,657)

Cost of hedging

(1,509)

(249)

519

28

Income tax (expense) benefit related to components of other comprehensive income that may be reclassified

(2,715)

4,441

(1,338)

2,797

(545,965)

354,549

(185,553)

(64,591)

Other comprehensive income (loss), net of tax

(567,980)

388,371

(176,973)

(28,006)

Total comprehensive income (loss)

(303,988)

535,432

445,779

447,854

Comprehensive income attributable to noncontrolling interests

504

95,667

137,574

172,444

Comprehensive income (loss) attributable to shareholders of FME AG

(304,492)

439,765

308,205

275,410

See accompanying notes to the interim consolidated financial statements (unaudited).

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FRESENIUS MEDICAL CARE AG

Consolidated balance sheets

(unaudited)

Consolidated balance sheets

in € THOUS, except share data

    

Note

    

September 30, 2024

    

December 31, 2023

Assets

Cash and cash equivalents

 

1,370,890

1,403,492

Trade accounts and other receivables from unrelated parties

 

3,243,980

3,471,213

Accounts receivable from related parties

 

4

34,752

165,299

Inventories

 

6

2,099,677

2,179,175

Other current assets

775,904

730,460

Other current financial assets

335,930

244,172

Assets held for sale

2

229,459

507,600

Total current assets

8,090,592

8,701,411

Property, plant and equipment

3,514,961

3,782,780

Right-of-use assets

 

3,462,255

3,671,241

Intangible assets

1,307,990

1,362,327

Goodwill

14,227,152

14,650,008

Deferred taxes

294,306

283,953

Investment in equity method investees

 

13

690,794

642,928

Other non-current assets

138,152

223,576

Other non-current financial assets

784,599

611,584

Total non-current assets

24,420,209

25,228,397

Total assets

32,510,801

33,929,808

Liabilities

Accounts payable to unrelated parties

771,663

762,068

Accounts payable to related parties

 

4

96,579

123,081

Current provisions and other current liabilities

1,546,258

1,617,434

Other current financial liabilities

1,594,658

1,675,556

Short-term debt from unrelated parties

 

7

103,925

456,904

Current portion of long-term debt

 

8

942,868

487,699

Current portion of lease liabilities from unrelated parties

 

573,730

593,033

Current portion of lease liabilities from related parties

 

4

24,789

23,926

Income tax liabilities

179,550

191,265

Liabilities directly associated with assets held for sale

2

55,029

180,624

Total current liabilities

5,889,049

6,111,590

Long-term debt, less current portion

 

8

6,234,448

6,959,863

Lease liabilities from unrelated parties, less current portion

 

3,229,537

3,419,338

Lease liabilities from related parties, less current portion

 

4

94,287

109,649

Non-current provisions and other non-current liabilities

351,725

332,813

Other non-current financial liabilities

564,223

715,660

Pension liabilities

664,050

664,327

Income tax liabilities

44,959

39,747

Deferred taxes

647,580

750,286

Total non-current liabilities

11,830,809

12,991,683

Total liabilities

17,719,858

19,103,273

Shareholders' equity:

Ordinary shares, no par value, €1.00 nominal value, 362,370,124 shares authorized, 293,413,449 issued and outstanding as of September 30, 2024 (December 31, 2023: 293,413,449)

293,413

293,413

Additional paid-in capital

3,377,048

3,380,331

Retained earnings

11,089,992

10,921,686

Accumulated other comprehensive income (loss)

(1,137,978)

(975,169)

Total FME AG shareholders' equity

13,622,475

13,620,261

Noncontrolling interests

1,168,468

1,206,274

Total equity

14,790,943

14,826,535

Total liabilities and equity

32,510,801

33,929,808

See accompanying notes to the interim consolidated financial statements (unaudited).

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FRESENIUS MEDICAL CARE AG

Consolidated statements of cash flows

(unaudited)

Consolidated statements of cash flows

in € THOUS

For the nine months ended

September 30, 

    

Note

    

2024

    

2023

Operating activities

Net income

622,752

475,860

Adjustments to reconcile net income to net cash provided by operating activities:

 

Depreciation, amortization and impairment loss

 

13

1,265,256

1,326,037

Change in deferred taxes, net

 

(119,165)

(89,516)

(Gain) loss from the sale of fixed assets, right-of-use assets, investments and divestitures

 

(38,148)

(30,321)

Income from equity method investees

 

13

(102,730)

(98,419)

Interest expense, net

 

255,688

251,832

Changes in assets and liabilities, net of amounts from businesses acquired:

 

Trade accounts and other receivables from unrelated parties

 

(228,737)

(165,006)

Inventories

 

12,236

(55,633)

Other current and non-current assets

 

(111,148)

55,456

Accounts receivable from related parties

 

129,582

88,971

Accounts payable to related parties

 

(23,882)

(26,501)

Accounts payable to unrelated parties, provisions and other current and non-current liabilities

 

116,245

161,626

Income tax liabilities

 

332,798

380,120

Received dividends from investments in equity method investees

5,151

148,096

Paid interest

 

(276,771)

(285,019)

Received interest

 

48,740

59,079

Paid income taxes

 

(333,425)

(286,927)

Net cash provided by (used in) operating activities

 

1,554,442

1,909,735

Investing activities

 

Purchases of property, plant and equipment and capitalized development costs

 

(458,668)

(434,318)

Acquisitions, net of cash acquired, investments and purchases of intangible assets

 

(18,509)

(21,085)

Investments in debt securities

(64,589)

(98,137)

Proceeds from sale of property, plant and equipment

 

6,504

4,728

Proceeds from divestitures, net of cash disposed

 

502,072

25,566

Proceeds from sale of debt securities

67,445

75,520

Net cash provided by (used in) investing activities

 

34,255

(447,726)

Financing activities

 

Proceeds from short-term debt from unrelated parties

 

182,287

367,783

Repayments of short-term debt from unrelated parties

 

(537,069)

(482,072)

Proceeds from short-term debt from related parties

 

10,204

Repayments of short-term debt from related parties

 

(11,204)

Proceeds from long-term debt

 

40,361

210,567

Repayments of long-term debt

 

(249,723)

(35,198)

Repayments of lease liabilities from unrelated parties

 

(484,526)

(527,693)

Repayments of lease liabilities from related parties

 

(18,666)

(19,196)

Increase (decrease) of accounts receivable facility

 

(22,995)

(92,311)

Dividends paid

(349,162)

(328,623)

Distributions to noncontrolling interests

 

(178,661)

(234,250)

Contributions from noncontrolling interests

 

14,039

29,118

Net cash provided by (used in) financing activities

 

(1,604,115)

(1,112,875)

Effect of exchange rate changes on cash and cash equivalents

 

(24,595)

(48,562)

Cash and cash equivalents:

 

Net increase (decrease) in cash and cash equivalents

 

(40,013)

300,572

Cash and cash equivalents at beginning of period

 

1,427,225

1,273,787

Cash and cash equivalents at end of period

 

1,387,212

1,574,359

Thereof: cash and cash equivalents within the disposal groups

 

2

16,322

21,106

See accompanying notes to the interim consolidated financial statements (unaudited).

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FRESENIUS MEDICAL CARE AG

Consolidated statements of shareholders’ equity

For the nine months ended September 30, 2024 and 2023 (unaudited)

Consolidated statements of shareholders’ equity

in € THOUS, except share data

Ordinary shares

Accumulated other comprehensive income (loss)

Additional

Foreign

Total FME AG

Non-

Number of

No par

paid in

Retained

currency

Cash flow

Fair value

shareholders’

controlling

    

Note

    

shares

    

value

    

capital

    

earnings

    

translation

    

hedges

    

Pensions

    

changes

    

 equity

    

 interests

    

Total equity

Balance at December 31, 2022

    

293,413,449

293,413

3,372,799

10,711,709

(207,210)

(627)

(155,526)

(25,105)

13,989,453

1,459,726

15,449,179

Proceeds from exercise of options and related tax effects

(1,190)

(1,190)

(1,190)

Dividends paid

(328,623)

(328,623)

(328,623)

Transactions with noncontrolling interests without loss of control

6,465

6,465

(11,903)

(5,438)

Noncontrolling interests due to changes in consolidation group

(12,569)

(12,569)

Contributions from/ to noncontrolling interests

(179,689)

(179,689)

Put option liabilities

 

12

65,044

65,044

65,044

Net Income

 

311,072

311,072

164,788

475,860

Other comprehensive income (loss) related to:

 

Foreign currency translation

 

(63,607)

(274)

(811)

(200)

(64,892)

7,656

(57,236)

Cash flow hedges, net of related tax effects

 

(4,544)

(4,544)

(4,544)

Pensions, net of related tax effects

23,145

23,145

23,145

Fair value changes, net of related tax effects

10,629

10,629

10,629

Comprehensive income

 

275,410

172,444

447,854

Balance at September 30, 2023

 

293,413,449

293,413

3,378,074

10,759,202

(270,817)

(5,445)

(133,192)

(14,676)

14,006,559

1,428,009

15,434,568

Balance at December 31, 2023

 

293,413,449

293,413

3,380,331

10,921,686

(765,581)

(4,585)

(192,490)

(12,513)

13,620,261

1,206,274

14,826,535

Dividends paid

(349,162)

(349,162)

(349,162)

Transactions with noncontrolling interests without loss of control

(3,283)

(3,283)

2,689

(594)

Noncontrolling interests due to changes in consolidation group

(23,000)

(23,000)

Contributions from/ to noncontrolling interests

(155,069)

(155,069)

Put option liabilities

 

12

46,454

46,454

46,454

Net Income

 

471,014

471,014

151,738

622,752

Other comprehensive income (loss) related to:

 

Foreign currency translation

 

(130,855)

63

1,451

(50,715)

(180,056)

(14,164)

(194,220)

Cash flow hedges, net of related tax effects

 

2,517

2,517

2,517

Pensions, net of related tax effects

12,853

12,853

12,853

Fair value changes, net of related tax effects

1,877

1,877

1,877

Comprehensive income

 

308,205

137,574

445,779

Balance at September 30, 2024

 

293,413,449

293,413

3,377,048

11,089,992

(896,436)

(2,005)

(178,186)

(61,351)

13,622,475

1,168,468

14,790,943

See accompanying notes to the interim consolidated financial statements (unaudited).

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

1.    The Company and basis of presentation

The Company

Fresenius Medical Care AG (FME AG or the Company) is a German stock corporation (Aktiengesellschaft — AG) registered with the commercial register of Hof (Saale) under HRB 6841, with its business address at Else-Kröner-Str. 1, 61352 Bad Homburg v. d. Höhe, Germany. The Company is the world’s leading provider of products and services for individuals with renal diseases, based on publicly reported revenue and number of patients treated. The Company provides dialysis and related services for individuals with renal diseases as well as other health care services. The Company also develops, manufactures and distributes a wide variety of health care products. The Company’s 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. The Company supplies dialysis clinics it owns, operates or manages with a broad range of products and also sells dialysis products to other dialysis service providers. The Company’s other health care services include value and risk-based care programs, pharmacy services, vascular specialty services as well as ambulatory surgery center services, physician nephrology practice management and ambulant treatment services.

In these unaudited notes, “FME AG,” the “Company” or the “Group” refers to Fresenius Medical Care AG or to Fresenius Medical Care AG and its subsidiaries on a consolidated basis, as the context requires. “Fresenius SE” and “Fresenius SE & Co. KGaA” refer to Fresenius SE & Co. KGaA. “Management Board” refers to the members of the management board of the Company and “Supervisory Board” refers to the supervisory board of the Company. The term “Care Enablement” refers to the Company’s Care Enablement operating segment and the term “Care Delivery” refers to the Care Delivery operating segment. For further discussion of the Company’s operating and reportable segments, see note 13.

At an extraordinary general meeting (EGM) of the Company held on July 14, 2023, the shareholders of the Company approved a proposal to change the legal form of the Company from a partnership limited by shares (Kommanditgesellschaft auf Aktien – KGaA) into an AG (the Conversion). Upon effectiveness of the Conversion, which occurred upon registration of the Conversion with the competent commercial register on November 30, 2023, the Company’s former general partner exited the Company, Fresenius SE ceased to control (as defined by IFRS 10, Consolidated Financial Statements) the Company and the Company ceased to be a member of the Fresenius SE consolidated group. Fresenius SE continues to have significant influence over the Company.

Basis of presentation

The consolidated financial statements and other financial information included in the Company’s quarterly reports furnished under cover of Form 6-K and its Annual Report on Form 20-F are prepared solely in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB), the “IFRS® Accounting Standards”, using the euro as the Company’s reporting and functional currency.

The interim financial report is prepared in accordance with International Accounting Standard (IAS) 34, Interim Financial Reporting, and contains condensed financial statements, in that it includes selected explanatory notes rather than all of the notes that would be required in a complete set of financial statements. However, the primary financial statements are presented in the format consistent with the consolidated financial statements as presented in the Company’s Annual Report on Form 20-F for the year ended December 31, 2023 (the 2023 Form 20-F) in accordance with IAS 1, Presentation of Financial Statements.

The interim consolidated financial statements at September 30, 2024 and for the three and nine months ended September 30, 2024 and 2023 contained in this report are unaudited and should be read in conjunction with the consolidated financial statements contained in the Company’s 2023 Form 20-F. The preparation of interim consolidated financial statements in conformity with IFRS Accounting Standards requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Such interim financial statements reflect all adjustments that, in the opinion of management, are necessary to provide a fair statement of the results of the periods presented. All such adjustments are of a normal recurring nature.

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

On February 21, 2024, one of the Company’s third-party service providers was subject to a cyber-attack leading to the shutdown of its systems. As this third party provided the Company with a range of financial clearinghouse services, the cyber-attack on its systems led to delays in claim processing impacting the Company’s consolidated financial statements, primarily affecting accounts receivable balances and cash flows. As this cyber-attack was pervasive within the health care industry, the U.S. Centers for Medicare & Medicaid Services (CMS) made certain advance payments to providers and suppliers experiencing claims disruptions related to the incident and the third party agreed to provide interest-free advance payments to the Company to mitigate the effect of the incident. As of September 30, 2024, the Company has returned substantially all of the CMS advanced payments and all of the third party interest-free advance payments. The remaining impact on the Company’s consolidated balance sheets and consolidated statements of cash flows is no longer material.

As noted in the Company’s 2023 Form 20-F within note 2 of the notes to the consolidated financial statements, significant judgments and sources of estimation are applied, particularly in relation to revenue recognition, trade accounts and other receivables from unrelated parties and expected credit losses. Upon the substantial resolution of the impacts of the third party cyber incident during the third quarter of 2024, the Company updated its methods, inputs and assumptions (including an assessment of consideration subject to constraint) used to estimate explicit and implicit price concessions. Changes to methods, inputs and assumptions related to the Company’s annual assessment of implicit price concessions in the U.S. Care Delivery segment are based on the best information available to the Company and did not result in a material change in the Company’s estimate of explicit and implicit price concessions.

The Company applies IAS 29, Financial Reporting in Hyperinflationary Economies (IAS 29), in its Lebanese and Turkish subsidiaries due to inflation in these countries. The table below details the date of initial application of IAS 29 and the specific inputs used to calculate the gain or loss on net monetary position on a country-specific basis for the nine months ended September 30, 2024. The ongoing re-translation effects of hyperinflationary accounting and its impact on comparative amounts are recorded in other comprehensive income (loss) within the Company’s interim consolidated financial statements. The subsequent gains or losses on net monetary position are recorded in other operating income and other operating expense, respectively, within the Company’s consolidated statements of income and within other current and non-current assets within the Company’s consolidated statements of cash flows.

Inputs for the calculation of (gains) losses on net monetary positions

    

Lebanon

    

Turkiye

Date of IAS 29 initial application

December 31, 2020

June 30, 2022

Consumer price index

Central Administration of Statistics

Turkish Statistical Institute

Index at September 30, 2024

6,608.0

2,526.2

Calendar year increase

11

%

36

%

(Gain) loss on net monetary position in € THOUS

(63)

8,975

The effective tax rate of 30.6% and 29.1% for the three and nine months ended September 30, 2024, respectively (37.6% and 31.0% for the three and nine months ended September 30, 2023), is recognized on the basis of the best estimate made for the weighted average annual income tax rate expected for the full year and applied to income before income taxes reported in the interim financial statements. Due to the size of the Company’s revenue, it is within the scope of the Organisation for Economic Co-operation and Development’s Inclusive Framework on Base Erosion Profit Shifting (BEPS) Global Anti-Base Erosion Model Rules (GloBE): Global Minimum Taxation (Pillar Two) legislation. The legislation was enacted in Germany on December 15, 2023, the jurisdiction in which the Company resides, and became effective on January 1, 2024. The Company applies the exception not to recognize or disclose deferred taxes in connection with Pillar Two income taxes. Estimated income tax expenses related to Pillar Two income taxes are included within the income tax expense line item in the Company’s consolidated statements of income and do not have a material impact on the Company’s interim consolidated financial statements.

The results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results of operations for the year ending December 31, 2024.

Goodwill as of September 30, 2024 was €14,227,152 (December 31, 2023: €14,650,008), thereof €12,171,616 (December 31, 2023: €12,573,423) in Care Delivery and €2,055,536 (December 31, 2023: €2,076,585) in Care Enablement.

In the first nine months of 2024, the market capitalization of the Company increased by 1% to €11,205,460 at September 30, 2024 (December 31, 2023: €11,137,975) and remains below total FME AG shareholders’ equity, which remained relatively stable at €13,622,475 as of September 30, 2024 as compared to €13,620,261 as of December 31, 2023.

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

Due to the carrying amount of net assets exceeding the Company’s market capitalization, a continued higher level of interest rates and ongoing uncertainties in the macroeconomic environment, the Company reviewed the impacts on the impairment test, which was performed as of December 31, 2023. Additionally, in 2023, a study on glucagon-like peptide 1 (GLP-1) receptor agonists, regarding its effectiveness in treating CKD experienced by diabetic patients was terminated early as a result of the study having met certain prespecified clinical endpoints. The ability to delay CKD or ESRD progression and cardiovascular mortality improvements as a result of the use of these and other pharmaceuticals or treatment modalities could have an impact on our patient population in the future and was included as a consideration for our goodwill impairment test review.

The Company expanded the analysis in 2024 in connection with the annual goodwill impairment test as of October 1, 2023 as performed during the fourth quarter of 2023 and as described in note 2 a) of the consolidated financial statements contained in the 2023 Form 20-F. The Company’s analysis included projections regarding the potential impact of GLP-1 receptor agonists and was expanded to consider the potential impact of sodium-glucose cotransporter 2 (SGLT2) inhibitors on the CKD and ESRD populations, specifically in relation to cash flow projections and goodwill sensitivity assessments. In the Company’s analysis of the population impact model (a computational tool to predict the size and age distribution of future patient populations with kidney disease for the coming decade, based on various public-health scenarios), the sensitivity bands of the various scenarios of GLP-1 receptor agonist and SGLT2 inhibitor utilization in the CKD population suggest a trend towards a slight increase in the total CKD population and a slight reduction in ESRD population that remains materially consistent with the patient population forecasts which do not include the utilization of these drugs.

During the third quarter of 2024, the Company compared the carrying amounts of its group of CGUs, Care Delivery and Care Enablement, to the respective group of CGU’s value in use, using the free cash flows of the group of CGUs considered in the impairment test as of December 31, 2023, and updated its free cash flow projections using the results of the latest available assessments. Cash flow projections were updated to reflect the impacts of divestitures and the classification of certain entities as held for sale during the first nine months of 2024 as disclosed in note 2 as well as the status of current initiatives, without considering any growth and improvement from initiatives related to the transformation of the Company’s operating structure and steps to achieve cost savings (FME25 Program) which have not yet commenced as of September 30, 2024.

The following table shows the key assumptions of value-in-use calculations, which are presented based upon the goodwill impairment tests performed as of September 30, 2024 and December 31, 2023.

Key assumptions

in %

    

Care Delivery

    

Care Enablement

    

September 30,
2024

    

December 31,
2023

    

September 30,
2024

    

December 31,
2023

Average revenue growth in ten year projection period

 

mid-single-digit

mid-single-digit

mid-single-digit

mid-single-digit

Average operating income growth in ten year projection period

 

high-single-digit

high-single-digit

low-double-digit

low-double-digit

Residual value growth

1.00

1.00

1.00

1.00

Pre-tax WACC

9.91

10.53

8.99

8.41

After-tax WACC

7.64

8.09

7.28

6.54

For a detailed description of the impairment test procedure, see notes 1 g) and 2 a) of the consolidated financial statements contained in the 2023 Form 20-F. As of September 30, 2024, the impairment test procedure was performed on our operating segments (Care Delivery and Care Enablement). The assessment did not result in any indication of impairment as of September 30, 2024. Management continues to monitor the situation.

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

As of September 30, 2024, the recoverable amount of the Care Delivery group of CGUs exceeded the carrying amount by €5,702,457 (December 31, 2023: €4,740,257). For the Care Enablement group of CGUs, the recoverable amount exceeded the carrying amount by €4,216,681 (December 31, 2023: €3,285,391). The following table shows the reasonable amounts by which the key assumptions would need to change individually that the recoverable amount equals the carrying amount:

Sensitivity analysis(1)

Change in percentage points

Care Delivery

Care Enablement

    

September 30,

    

December 31,

    

September 30,

    

December 31,

    

2024

    

 2023

    

2024

    

2023

Pre-tax WACC

    

2.36

    

2.10

    

2.74

    

2.27

After-tax WACC

 

1.77

 

1.60

 

2.03

 

1.66

Residual value growth

 

(7.72)

 

(7.26)

 

(6.95)

 

(5.57)

Operating income margin of each projection year

 

(2.43)

 

(2.35)

 

(3.61)

 

(3.02)

(1) The sensitivity analysis is based upon the goodwill impairment tests performed as of September 30, 2024 and December 31, 2023.

On November 5, 2024, the Management Board authorized the issuance of the Company’s interim consolidated financial statements (unaudited).

New accounting pronouncements

Recently implemented accounting pronouncements

The Company has prepared its interim consolidated financial statements at and for the nine months ended September 30, 2024 in conformity with IFRS Accounting Standards that have to be applied for the interim periods starting on or after January 1, 2024. In the nine months ended September 30, 2024, there were no recently implemented accounting pronouncements that materially affect the business.

Recent accounting pronouncements not yet adopted

The IASB issued the following new standard which is relevant for the Company:

IFRS 18, Presentation and Disclosure in Financial Statements

On April 9, 2024, the IASB issued IFRS 18, Presentation and Disclosure in Financial Statements (IFRS 18). IFRS 18 aims to improve how information is communicated in financial statements to give investors a more comparable basis to analyze companies’ performance. The standard introduces three sets of new requirements: new categories and subtotals in the consolidated statements of income, disclosure regarding management-defined performance measures and guidance related to the aggregation and disaggregation of certain information. The consolidated statements of income will be split into three newly defined categories (operating, investing and financing) and will include two newly defined subtotals (operating profit and profit before financing and income taxes). Management-defined performance measures are subtotals of income and expense used in public communication outside the financial statements and communicate management’s view of certain aspects of a company’s performance. Such measures are required to be described in a clear and understandable manner in a single note explaining how the measure is calculated, why it is useful, providing a reconciliation to the most directly comparable subtotal noted above, the income tax and the effect on non-controlling interest for each item disclosed in the reconciliation and how the income tax effect was determined. Lastly, companies must disaggregate items if such information is material and avoid using the label “other” in financial statements. Certain additional details for depreciation and amortization, impairment and other expense classifications may be required. IFRS 18 is effective for fiscal periods commencing on or after January 1, 2027. Earlier adoption is permitted. The standard is expected to impact the Company’s presentation of items within the consolidated financial statements and its notes disclosures once implemented, though the standard is not expected to change how the Company recognizes or measures items in its consolidated financial statements.

Disclosure of Revenues and Expenses for Reportable Segments under IFRS 8, Operating Segments (International Financial Reporting Interpretations Committee Agenda Decision)

In July 2024, the International Financial Reporting Interpretations Committee issued an agenda decision on the disclosure of revenues and expenses for reportable segments under IFRS 8, Operating Segments. Under IFRS 8, companies are required to disclose certain specified income and expense items if such items are included within the segment profit measure that is provided to the chief operating decision maker, regardless of whether such items are provided to the chief operating decision maker separately. The agenda decision further clarifies that additional material items of income and expense included within a measure of segment profit reported to the chief operating decision maker may also need to be disclosed, based on management judgment. The Company is currently evaluating whether the International Financial Reporting Interpretations Committee decision has an impact on segment reporting to date.

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

In the Company’s view, no other pronouncements issued by the IASB are expected to have a material impact on the consolidated financial statements.

2.    Disposal groups classified as held for sale

As of September 30, 2024, the Company’s management committed to a plan to sell its renal dialysis clinic facilities and/or networks in Brazil and Colombia in connection with its Legacy Portfolio Optimization program (as defined below). Each business is currently included in the Company’s Care Delivery segment.

Transactions which remain open as of the date of this report are subject to regulatory approvals or certain other closing conditions, but are expected to be completed within a year from the date of classification as assets held for sale. Immediately before the classification of these disposals as held for sale, an impairment loss was recognized for the agreed-upon divestitures and is included in other operating expenses in the consolidated statements of income (see note 3 for further details). The carrying amounts of the disposal groups for the proposed divestiture of facilities in Brazil and Colombia are recognized at their fair value less costs to sell. The portion of the non-recurring fair value measurement attributable to the Company and its shareholders of €153,266 for these transactions is categorized as level 3 of the fair value hierarchy using the preliminary purchase price.

As of September 30, 2024 and December 31, 2023, the following assets and liabilities were classified as held for sale:

Assets and liabilities of disposal groups classified as held for sale

in € THOUS

    

September 30, 2024

    

December 31, 2023

Cash and cash equivalents

16,322

23,733

Trade accounts and other receivables from unrelated parties

68,570

27,535

Property, plant and equipment

24,255

42,710

Right-of-use assets

 

10,703

 

114,602

Goodwill(1)

89,613

274,543

Other

19,996

24,477

Assets held for sale

229,459

507,600

Accounts payable to unrelated parties

7,820

12,880

Lease liabilities

10,407

128,653

Provisions and other liabilities

36,802

39,091

Liability directly associated with assets held for sale

55,029

180,624

(1)Goodwill was allocated to the disposal groups on a relative fair value basis.

As of September 30, 2024, the accumulated foreign currency translation losses recognized in other comprehensive income related to the disposal groups amounted to €68,391.

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

3.    Notes to the consolidated statements of income

a)    Revenue

The Company has adjusted the prior year financial information below in order to include additional contracts identified during the course of the year ended December 31, 2023 which were subject to certain disclosures in accordance with IFRS 17.

The Company has recognized the following revenue in the consolidated statements of income for the three and nine months ended September 30, 2024 and 2023:

Revenue

in € THOUS

    

Revenue from

Revenue from

    

contracts with

    

insurance

    

Revenue from

    

    

customers

    

contracts

    

lease contracts

    

Total

For the three months ended September 30, 2024

Health care services

3,292,628

429,946

    

    

3,722,574

Health care products

 

1,021,882

15,706

1,037,588

Total

 

4,314,510

429,946

15,706

4,760,162

    

For the three months ended September 30, 2023

Revenue from

Revenue from

    

contracts with

    

insurance

    

Revenue from

    

    

customers

    

contracts

    

lease contracts

    

Total

Health care services

3,570,987

    

356,382

    

    

3,927,369

Health care products

 

988,559

20,309

1,008,868

Total

 

4,559,546

356,382

20,309

4,936,237

    

For the nine months ended September 30, 2024

    

Revenue from

    

Revenue from

    

    

contracts with

insurance

Revenue from

customers

contracts

lease contracts

Total

Health care services

9,986,979

 

1,205,997

 

 

11,192,976

Health care products

3,000,649

 

 

57,497

 

3,058,146

Total

12,987,628

 

1,205,997

 

57,497

 

14,251,122

    

For the nine months ended September 30, 2023

    

Revenue from

    

Revenue from

    

    

contracts with

insurance

Revenue from

customers

contracts

lease contracts

Total

Health care services

10,541,719

 

927,009

 

 

11,468,728

Health care products

2,952,592

 

 

44,411

 

2,997,003

Total

13,494,311

 

927,009

 

44,411

 

14,465,731

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

The following table contains a disaggregation of revenue by categories for the three and nine months ended September 30, 2024 and 2023:

Disaggregation of revenue by categories

in € THOUS

    

For the three months ended

    

For the nine months ended

September 30,

September 30,

    

2024

    

2023

    

2024

    

2023

Care Delivery

    

  

    

  

    

  

    

  

US

3,180,368

3,221,467

9,439,442

9,344,057

International

590,070

752,801

1,890,450

2,258,300

Total(1)

3,770,438

3,974,268

11,329,892

11,602,357

Care Enablement

Total (including inter-segment revenues)(1)

1,359,407

1,330,023

4,019,835

3,965,292

Inter-segment eliminations

(369,683)

(368,054)

(1,098,605)

(1,101,918)

Total Care Enablement revenue external customers

989,724

961,969

2,921,230

2,863,374

Total

4,760,162

4,936,237

14,251,122

14,465,731

(1) For further information on segment revenues, see note 13.

b)    Selling, general and administrative expense

Selling, general and administrative expense recorded in the consolidated statements of income comprises both distribution costs as well as general and administrative expense. Distribution costs are generated in the selling, marketing and warehousing functions of the Company which are not attributable to production or research and development (R&D). General and administrative expense is generated in the administrative function of the Company’s business and is not attributable to selling, production or R&D.

The following table discloses the distribution costs as well as general and administrative expense recorded by the Company for the three and nine month period ended September 30, 2024 and 2023:

Selling, general and administrative expense

in € THOUS

    

For the three months ended 

    

For the nine months ended 

September 30, 

September 30, 

2024

    

2023

2024

    

2023

Distribution costs

200,325

202,256

581,861

605,086

General and administrative expense

555,821

591,534

1,721,395

1,746,093

Selling, general and administrative expense

756,146

793,790

2,303,256

2,351,179

c)    Research and development expenses

Research and development expenses of €133,433 for the nine months ended September 30, 2024 (for the nine months ended September 30, 2023: €165,985) included research and non-capitalizable development costs.

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

d)    Other operating income and expense

The following table contains reconciliations of the amounts included in other operating income and expense for the three and nine months ended September 30, 2024 and 2023:

Other operating income

in € THOUS

    

For the three months ended

    

For the nine months ended

September 30,

September 30,

    

2024

    

2023

    

2024

    

2023

Foreign exchange gains

61,274

42,756

180,984

168,737

Gains on right-of-use assets, from the sale of fixed assets, clinics and investments

14,131

638

20,952

26,212

Revaluation of certain investments

18,107

1,382

79,190

16,350

Income attributable to a consent agreement on foregone profits from the sale of certain pharmaceuticals to non-associated companies

62,369

62,369

Income from strategic transactions and programs

16,079

103,576

Other

19,106

19,836

85,423

46,614

Other operating income

191,066

64,612

532,494

257,913

Other operating expense

in € THOUS

    

For the three months ended

    

For the nine months ended

    

September 30,

September 30,

    

2024

    

2023

2024

    

2023

Foreign exchange losses

74,248

39,691

209,471

194,105

Losses on right-of-use assets, from the sale of fixed assets, clinics and investments

5,881

1,479

8,951

20,148

Expenses from strategic transactions and programs

3,897

66,460

266,327

181,913

Other

35,483

37,555

66,512

76,560

Other operating expense

119,509

145,185

551,261

472,726

Included within the “income from strategic transactions and programs” line item in other operating income are the gains from divestitures of certain businesses in connection with strategic programs such as Legacy Portfolio Optimization, defined below, and the FME25 Program. The amount presented for the three months ended September 30, 2024 primarily relates to the revaluation of certain assets held for sale and the divestiture of certain clinics as part of Legacy Portfolio Optimization. The amount presented for the nine months ended September 30, 2024 primarily relates to the divestiture of Cura Day Hospitals Group in Australia as part of Legacy Portfolio Optimization.

Included within the “expenses from strategic transactions and programs” line item in other operating expense are the proposed divestitures (including associated impairment losses) of certain businesses in connection with strategic programs such as Legacy Portfolio Optimization, defined below, and the FME25 Program. For further information on the proposed divestitures and associated impairment losses, see note 2. Consistent with the Company’s policy to present impairment losses within other operating expense, such costs related to cost of revenues, selling, general and administrative expense or research and development expenses are included within other operating expense. “Expenses from strategic transactions and programs” primarily consist of:

strategic divestiture program expenses identified during the review of the Company’s business portfolio, mainly due to exiting unsustainable markets and divesting non-core businesses, as well as the cessation of certain research and development programs to enable more focused capital allocation towards areas in the Company’s core business that are expected to have higher profitable growth, which included the proposed divestitures identified in note 2, above, the cessation of a dialysis cycler development program and the divestiture of the Company’s service businesses in Chile, Ecuador, Sub-Saharan Africa, Turkiye, Guatemala, Curacao, Peru and the Cura Day Hospitals Group in Australia (Legacy Portfolio Optimization) including related reclassification adjustments of foreign currency translation amounts previously classified within other comprehensive income in the amount of (€14) and €96,962 for the three and nine months ended September 30, 2024 (for the three and nine months ended September 30, 2023, there were no reclassification adjustments);
certain impairment losses in connection with the FME25 Program; and
certain costs associated with the Conversion, primarily related to the requisite relabeling of its 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).

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

Expenses from strategic transactions and programs comprised the following for the three and nine months ended September 30, 2024 and 2023:

Expenses from strategic transactions and programs

in € THOUS

    

For the three months ended

    

For the nine months 

September 30,

ended September 30,

2024

    

2023

2024

    

2023

Derecognition of capitalized development costs and termination costs(1)

 

11

58,298

Legacy Portfolio Optimization

11

58,298

Impairment of intangible and tangible assets(2)

 

897

5,842

3,361

43,290

Legacy Portfolio Optimization

(167)

34,883

FME25 Program

 

897

6,009

3,361

8,407

Impairment resulting from the measurement of assets held for sale

 

(2,340)

52,473

117,837

64,365

Legacy Portfolio Optimization

(2,340)

52,473

117,837

52,473

FME25 Program

11,892

Loss from the sale of business

2,808

111,855

Legacy Portfolio Optimization

2,808

111,855

Other(3)

2,532

8,134

33,274

15,960

Legacy Portfolio Optimization

577

1,775

28,050

2,899

Legal Form Conversion Costs

1,955

6,359

5,224

13,061

Expenses from strategic transactions and programs

 

3,897

66,460

266,327

181,913

(1) Primarily R&D expense.
(2) For the three and nine months ended September 30, 2024 and 2023, the amounts relate primarily to cost of revenues and R&D expense, respectively.
(3) For the three and nine months ended September 30, 2024 and 2023, the amounts relate primarily to selling, general and administrative expense.

For more information on the disposal groups classified as held for sale, see note 2.

e)    Earnings per share

The following table contains reconciliations of the numerators and denominators of the basic and diluted earnings per share computations for the three and nine months ended September 30, 2024 and 2023:

Reconciliation of basic and diluted earnings per share

in € THOUS, except share and per share data

    

For the three months ended

For the nine months ended

    

September 30, 

September 30, 

    

2024

    

2023

    

2024

    

2023

Numerator:

 

  

 

  

Net income attributable to shareholders of FME AG

213,027

84,351

471,014

311,072

Denominators:

Weighted average number of shares outstanding

293,413,449

293,413,449

293,413,449

293,413,449

Potentially dilutive shares

Basic earnings per share

 

0.73

0.29

1.61

1.06

Diluted earnings per share

 

0.73

0.29

1.61

1.06

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

4.    Related party transactions

Fresenius SE is the Company’s largest shareholder and owns 32.2% of the Company’s outstanding shares at September 30, 2024. Under the Company’s Articles of Association, Fresenius SE has the right to appoint two of the six shareholder representatives to the Company’s Supervisory Board. 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. The Company has entered into certain arrangements for services and products with Fresenius SE or its subsidiaries and with certain of the Company’s equity method investees as described in item a) below. The arrangements for leases with Fresenius SE or its subsidiaries are described in item b) below. The Company’s terms related to the receivables or payables for these services, leases and products are generally consistent with the normal terms of the Company’s ordinary course of business transactions with unrelated parties and the Company believes that these arrangements reflect fair market terms. The Company utilizes various methods to verify the commercial reasonableness of its related party arrangements. Financing arrangements with certain equity-method investees as described in item c) below have agreed-upon terms which are determined at the time such financing transactions occur and reflect market rates at the time of the transaction. The relationship between the Company and its key management personnel who are considered to be related parties is described in item d) below.

a)    Service agreements and products

Prior to the Conversion, the Company was party to service agreements with Fresenius SE and certain of its affiliates (collectively, Fresenius SE Companies) to receive services, including, but not limited to: administrative services, management information services, employee benefit administration, insurance, information technology services, tax services and treasury management services. These related party agreements generally had a duration of 1 to 5 years and were renegotiated on an as needed basis when the respective agreement expired.

In connection with and subsequent to the Conversion, the Company entered into transition service agreements with Fresenius SE Companies to receive services, including, but not limited to: administrative and facility management services, employee benefit administration, insurance brokerage, information technology, intellectual property and certain treasury services. These related party agreements have generally been entered into for transitional periods of several months up to 2 years (in some cases with extension options). Additionally, the Company also entered into various service agreements with Fresenius SE Companies to provide services, including, but not limited to, fixed asset accounting services and IT and communications-related services for up to a year.

The Company provides administrative services to one of its equity method investees. The Company also sells products to Fresenius SE Companies and purchases products from Fresenius SE Companies and equity method investees. In connection with, and subsequent to, the Conversion, the Company entered into a limited amount of shared procurement contracts with Fresenius SE Companies for the purchase of products from third parties.

In December 2010, the Company and Galenica Ltd. (now known as CSL Vifor) formed the renal pharmaceutical company Vifor Fresenius Medical Care Renal Pharma Ltd., an equity method investee of which the Company owns 45%. The Company has entered into exclusive supply agreements to purchase certain pharmaceuticals from, as well as into certain exclusive distribution agreements with, Vifor Fresenius Medical Care Renal Pharma Ltd.

Below is a summary, including the Company’s receivables from and payables to the indicated parties, resulting from the above-described transactions with related parties.

Service agreements and products with related parties

in € THOUS

For the nine months ended

For the nine months ended

  

  

    

September 30, 2024

    

September 30, 2023

    

September 30, 2024

  

December 31, 2023

    

Sales of

    

Purchases of

    

Sales of

    

Purchases of

    

    

    

    

    

goods and

    

goods and

    

goods and

    

goods and

    

Accounts

    

Accounts

    

Accounts

    

Accounts

    

services

    

services

    

services

    

services

    

receivable

    

payable

    

receivable

    

payable

Service agreements (1)

  

  

  

  

  

  

  

 

  

Fresenius SE

61

16,217

108

28,405

131

279

10

1,778

Fresenius SE affiliates

627

59,813

2,882

52,224

302

4,432

589

14,299

Equity method investees

5,025

5,694

50

17,984

51,442

Total

5,713

76,030

8,684

80,679

18,417

4,711

52,041

16,077

Products

Fresenius SE affiliates(2)

49,880

16,303

53,689

18,206

16,335

5,159

23,535

9,585

Equity method investees

290,892

337,677

63,036

67,403

Total

49,880

307,195

53,689

355,883

16,335

68,195

23,535

76,988

(1) In addition to the above shown accounts payable, accrued expenses for service agreements with related parties amounted to €23,504 and €5,172 at September 30, 2024 and December 31, 2023, respectively.
(2) Purchases of goods related to Fresenius SE affiliates for the nine months ended September 30, 2023 in the amount of (€13,266) were adjusted to correct for an error in presentation. The adjustment does not have an impact on the Company’s consolidated statements of income for the periods presented.

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

b)    Lease agreements

In addition to the above-mentioned product and service agreements, the Company is a party to real estate lease agreements with Fresenius SE Companies, which mainly include leases for the Company’s corporate headquarters in Bad Homburg, Germany, and production sites in Schweinfurt and St. Wendel, Germany. The leases have maturities up to the end of 2032.

Below is a summary resulting from the above described lease agreements with related parties.

Lease agreements with related parties

in € THOUS

    

For the nine months ended September 30, 2024

    

For the nine months ended September 30, 2023

    

September 30, 2024

    

December 31, 2023

    

Interest

    

Lease

    

    

Interest

    

Lease

    

Right-of-use

    

Lease

    

Right-of-use

    

Lease

    

Depreciation

    

expense

    

expense (1)

    

Depreciation

    

expense

    

expense (1)

    

asset

    

liability

    

asset

    

liability

Fresenius SE

4,943

237

70

6,150

1,004

293

24,646

27,090

29,214

29,017

Fresenius SE affiliates

13,811

1,460

13,361

1,055

91,581

91,986

102,029

104,558

Total

18,754

1,697

70

19,511

2,059

293

116,227

119,076

131,243

133,575

(1) Short-term leases and expenses relating to variable lease payments as well as low value leases are exempted from balance sheet recognition.

c)    Financing

As of September 30, 2024 and December 31, 2023, the Company had outstanding accounts payable related to a cash pooling program with certain equity-method investees in the amount of €23,673 and €26,875, respectively. The interest rates for these cash management arrangements were set on a daily basis and were based on the then-prevailing overnight reference rate, with a floor of zero, for the respective currencies.

d)    Key management personnel

Due to the Company’s previous legal form of a German partnership limited by shares until the effectiveness of the Conversion, Fresenius Medical Care Management AG (Management AG), the Company’s former general partner (General Partner), held a key management position within the Company. In addition, as key management personnel, members of the management board and supervisory board of Management AG, as well as their close relatives, were considered related parties. Upon effectiveness of the Conversion, the General Partner exited the Company and is no longer entitled to reimbursement of the remuneration of its board members (other than outstanding amounts, if any, for service prior to the effective date of the Conversion as set forth below). The members of the Supervisory Board and the newly established Management Board, as key management personnel, as well as their close relatives, are considered related parties of the Company. Also upon effectiveness of the Conversion, the existing service agreements between the General Partner and the members of the management board of Management AG were transferred to FME AG. The Company has also entered into service agreements with new members of the Management Board who joined the Company subsequent to the Conversion. The long-term incentive plans of Management AG applying to the former members of the management board of Management AG established before the Conversion were adopted by the Supervisory Board as compensation plans of the Company. For further information regarding the Conversion, see note 1.

Prior to the Conversion, the Company’s Articles of Association provided that the General Partner shall be reimbursed for any and all expenses in connection with the management of the Company’s business, including remuneration of the members of the General Partner’s supervisory board and the members of the management board of Management AG. The aggregate amount reimbursed to the General Partner was €23,574 for its management services during the nine months ended September 30, 2023. As of September 30, 2024, the Company did not have accounts receivable from or accounts payable to the General Partner. As of December 31, 2023, the Company had accounts receivable from the General Partner in the amount of €89,723 and accounts payable to the General Partner in the amount of €3,141.

40

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

5.    Insurance contracts

The following tables provide reconciliations of the Company’s portfolios of insurance and reinsurance contracts, showing the change in insurance and reinsurance contract receivables (liabilities) as of September 30, 2024 and December 31, 2023. As of September 30, 2024, these receivables (liabilities) are recognized in the consolidated balance sheet within trade accounts and other receivables from unrelated parties (accounts payable to unrelated parties) which were previously presented on a net basis within trade accounts and other receivables from unrelated parties as of December 31, 2023.

Reinsurance contract receivables and liabilities

in € THOUS

    

2024

    

2023

    

Present 

    

Risk 

    

    

Present 

    

Risk 

    

value of

adjustment 

value of 

adjustment 

future cash

for non-

future cash

for non-

 flows

financial risk

Total

flows

financial risk

Total

Reinsurance contract receivables (liabilities) at the beginning of the period

    

53,137

(931)

52,206

23,925

(1,801)

22,124

Incurred claims and other directly attributable expenses

(223,898)

206

(223,692)

(166,161)

825

(165,336)

Changes that relate to past service – changes in the fulfillment cash-flows relating to LIC(1)

(40,438)

(40,438)

1,544

1,544

Claims and other directly attributable expenses paid

(362,548)

(362,548)

(387,949)

(387,949)

Premium revenue

600,813

600,813

583,269

583,269

Foreign currency translation and other changes

62

6

68

(1,491)

45

(1,446)

Reinsurance contract receivables (liabilities) at the end of the period

27,128

(719)

26,409

53,137

(931)

52,206

(1) Changes that relate to past service include premium revenue for past performance years of (€4,987) and €9,038 as of September 30, 2024 and December 31, 2023, respectively.

Insurance contract receivables and liabilities

in € THOUS

2024

2023

Present 

Risk 

Present 

Risk 

value of

adjustment 

value of 

adjustment 

future cash

for non-

future cash

for non-

    

flows

    

financial risk

    

Total

    

flows

    

financial risk

    

Total

Insurance contract receivables (liabilities) at the beginning of the period

27,389

(553)

26,836

20,669

(254)

20,415

Incurred claims and other directly attributable expenses

(225,237)

45

(225,192)

(208,884)

(314)

(209,198)

Changes that relate to past service – changes in the fulfillment cash-flows relating to LIC(1)

3,121

3,121

(2,666)

(2,666)

Claims and other directly attributable expenses paid

(378,459)

(378,459)

(423,377)

(423,377)

Premium revenue

611,974

611,974

642,529

642,529

Foreign currency translation and other changes

(686)

6

(680)

(882)

15

(867)

Insurance contract receivables (liabilities) at the end of the period

38,102

(502)

37,600

27,389

(553)

26,836

(1) Changes that relate to past service include a reduction in premium revenue for past performance years of €1,804 and €7,696 as of September 30, 2024 and December 31, 2023, respectively.

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

6.   Inventories

At September 30, 2024 and December 31, 2023, inventories consisted of the following:

Inventories

in € THOUS

    

September 30,

    

December 31,

    

2024

    

2023

Finished goods

1,211,228

1,232,702

Health care supplies

404,191

451,316

Raw materials and purchased components

349,293

361,804

Work in process

134,965

133,353

Inventories

2,099,677

2,179,175

7.    Short-term debt

At September 30, 2024 and December 31, 2023, short-term debt consisted of the following:

Short-term debt

in € THOUS

    

September 30,

    

December 31,

    

2024

    

2023

Commercial paper program

99,749

399,078

Borrowings under lines of credit

4,013

57,754

Other

163

72

Short-term debt

103,925

456,904

The Company and certain consolidated entities operate a multi-currency notional cash pooling management system. In this cash pooling management system, amounts in euro and other currencies are offset without being transferred to a specific cash pool account. The system is used for an efficient utilization of funds within the Company. The Company met the conditions to offset balances within this cash pool for reporting purposes. At September 30, 2024 and December 31, 2023, cash and borrowings under lines of credit in the amount of €251,613 and €126,836, respectively, were offset under this cash pooling management system. Before this offset, cash and cash equivalents as of September 30, 2024 was €1,622,503 (December 31, 2023: €1,530,328) and short-term debt from unrelated parties was €355,538 (December 31, 2023: €583,740).

Commercial paper program

The Company maintains a commercial paper program under which short-term notes of up to €1,500,000 can be issued. At September 30, 2024, the outstanding commercial paper amounted to €100,000 (December 31, 2023: €400,000).

8.    Long-term debt

As of September 30, 2024 and December 31, 2023, long-term debt consisted of the following:

Long-term debt

in € THOUS

    

September 30,

    

December 31,

    

2024

    

2023

Schuldschein loans

225,964

228,759

Bonds

6,648,399

6,676,465

Accounts Receivable Facility

22,857

Other

302,953

519,481

Long-term debt

7,177,316

7,447,562

Less current portion

(942,868)

(487,699)

Long-term debt, less current portion

6,234,448

6,959,863

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

Accounts Receivable Facility

The Company maintained an accounts receivable securitization program (Accounts Receivable Facility) with a maximum capacity of $900,000 (€768,049 at the date of execution) and an ending term date of August 11, 2024. On May 31, 2024, the Company voluntarily terminated the Accounts Receivable Facility.

The following table shows the available and outstanding amounts under the Accounts Receivable Facility at September 30, 2024 and December 31, 2023:

Accounts Receivable Facility - maximum amount available and balance outstanding

in THOUS

 

Maximum amount available

 

Balance outstanding

    

September 30, 2024

    

September 30, 2024

    

    

    

    

Accounts Receivable Facility

$

$

 

Maximum amount available(1)

 

Balance outstanding(2)

    

December 31, 2023

    

December 31, 2023

    

    

    

    

Accounts Receivable Facility

$

900,000

814,482

$

25,000

22,624

(1) Subject to availability of sufficient accounts receivable meeting funding criteria.
(2) Amounts shown are excluding debt issuance costs.

The Company also had letters of credit outstanding under the Accounts Receivable Facility in the amount of $28,332 (€25,640) at December 31, 2023. These letters of credit are not included above as part of the balance outstanding at December 31, 2023. However, the letters reduced available borrowings under the Accounts Receivable Facility.

Syndicated Credit Facility

The Company entered into a €2,000,000 sustainability-linked syndicated revolving credit facility (Syndicated Credit Facility) in July 2021, which serves as a back-up line for general corporate purposes and was undrawn as of September 30, 2024. On June 2, 2023, the Syndicated Credit Facility was extended an additional year until July 1, 2028, with a maximum available borrowing amount of €1,959,184 in the last year.

9.    Capital management

As of September 30, 2024 and December 31, 2023 total equity in percent of total assets was 45.5% and 43.7%, respectively, and debt and lease liabilities (including amounts directly associated with assets held for sale) in percent of total assets was 34.5% and 35.9%, respectively.

The Company’s financing structure and business model are reflected in its credit ratings. The Company is rated investment grade by Standard & Poor’s, Moody’s and Fitch. On May 17 2024, Moody’s affirmed the Baa3 corporate credit rating and changed the outlook from negative to stable.Standard and Poor’s and Fitch affirmed the BBB- corporate credit rating and changed the outlook from negative to stable on May 23, 2024 and August 2, 2024, respectively.

The Company’s current corporate credit ratings and outlooks from the credit rating agencies are provided in the table below:

Rating (1)

    

Standard & Poor´s

    

Moody´s

    

Fitch

Corporate credit rating

 

BBB-

 

Baa3

 

BBB-

Outlook

 

stable

 

stable

 

stable

(1) A rating is not a recommendation to buy, sell or hold securities of the Company, and may be subject to suspension, change or withdrawal at any time by the assigning rating agency.

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

10.    Share-based plans

With effect from January 1, 2024, the Fresenius Medical Care Management Board Long-Term Incentive Plan 2024+ (MB LTIP 2024+) was introduced as a new long-term incentive compensation plan for members of the Management Board. For members of the management boards of affiliated companies and managerial staff members, the Management Board resolved on the introduction of the Fresenius Medical Care Long-Term Incentive Plan 2024+ (LTIP 2024+), also with effect from January 1, 2024. The MB LTIP 2024+ succeeds the Fresenius Medical Care Long Term Incentive Plan 2020 (MB LTIP 2020) and the LTIP 2024+ succeeds the Fresenius Medical Care Long-Term Incentive Plan 2022+ (LTIP 2022+), under which allocations are no longer made since January 1, 2024. These multi-year compensation plans shall ensure continuous incentivization based on the long-term sustainable success of the Company.

The MB LTIP 2024+ and the LTIP 2024+ are variable compensation plans with long-term incentive effects. Participants of the MB LTIP 2024+ and of the LTIP 2024+ can be allocated so-called performance shares. Performance shares are compensation instruments which may entitle plan participants to receive a cash payment based on the achievement of pre-defined performance targets (further defined below) as well as the Company’s share price development throughout the respective vesting period (Performance Shares). For allocations under the MB LTIP 2024+ which have not yet been effected, the Supervisory Board may instead determine to settle in Fresenius Medical Care AG shares prior to each allocation.

For members of the Management Board, the respective allocation value is determined by the Supervisory Board. For members of the management boards of affiliated companies and managerial staff members, the respective allocation value is determined by the Management Board. The allocation value is determined in the currency in which the respective participant receives his or her base salary at the time of the allocation. Allocation values not denominated in euros are converted by using a fixed foreign exchange rate. In order to determine the number of Performance Shares that each plan participant receives, the allocation value is divided by the value per Performance Share at the time of the allocation, which in turn is determined based on the Company’s average share price over a period of thirty calendar days prior to the respective allocation date and assuming a 100% target achievement for the performance target total shareholder return (TSR) compared to competitors (Relative TSR) which is described below. The number of allocated Performance Shares may change over the performance period, which commenced on January 1, 2024 and ends on December 31, 2026 for all allocations in fiscal year 2024, depending on the degree of achievement of the performance targets.

For allocations in fiscal year 2024, the performance targets are as follows: (i) return on invested capital (ROIC), (ii) Relative TSR and (iii) sustainability measured by the reduction of emissions in CO2 equivalents (CO2e Reduction). The CO2e Reduction reflects the Company’s expressed goal to reduce Scope-1 and Scope-2 emissions by 50% by 2030 compared to 2020 and to achieve climate neutrality by 2040. For all three performance targets, target achievement corridors which will be used for the calculation of the respective target achievements were defined. These corridors were defined by the Supervisory Board for the MB LTIP 2024+ and by the Management Board for the LTIP 2024+. The corridors are identical for both plans.

For allocations in fiscal year 2024, the profitability target ROIC has a weight of 40% within the calculation of the degree of the overall target achievement and is based on the Company’s consolidated, reported and audited financial statements determined in accordance with IFRS and in line with the respective plan conditions. The ROIC target achievement level is determined based on the average of the three annual ROIC figures during the performance period.

For allocations in fiscal year 2024, the performance target Relative TSR is measured on the basis of the TSR compared to European and U.S. peer groups. The target achievement for this performance target is determined using the percentile ranking method. For this purpose, the TSR values of the peer companies within the respective comparison groups over the performance period are ranked and the relative positioning of the Company within the respective comparison group is determined on the basis of the percentile achieved. The performance target Relative TSR is weighted with 40% within the calculation of the degree of overall target achievement.

For allocations in fiscal year 2024, the achievement of the sustainability performance target CO2e Reduction is based on the Non-financial Group Reports (or any successor corporate sustainability reports), such reports being reviewed by an independent auditor, and is measured by the reduction of emissions in CO2 equivalents in comparison to the base year 2020. This reduction is expressed in percent. The sustainability performance target has a weight of 20% within the calculation of the degree of overall target achievement. The applicable target achievement of the sustainability target is calculated based on the average annual achievement in CO2e Reductions. For this purpose, each annual target achievement is weighted equally (1/3 each).

The number of Performance Shares allocated at the beginning of the performance period to the plan participants is multiplied with the degree of overall target achievement to determine the final number of Performance Shares.

Under the MB LTIP 2024+, the final number of Performance Shares generally vests four years after the allocation date. Several payout conditions, such as the continuation of the service relationship (with exceptions, e.g., in the event of occupational disability or retirement), apply. The number of vested Performance Shares is multiplied by the average share price of the Company during a period of 30 days prior to the end of the vesting period. The resulting amount is capped at 400% of the respective allocation value and will be paid out as cash compensation or settled in shares of the Company.

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

Under the LTIP 2024+, the final number of Performance Shares generally vests three years after the allocation date. Several payout conditions, such as the continuation of the employment or service relationship (with exceptions, e.g., in the event of occupational disability or retirement), apply. The number of vested Performance Shares is multiplied by the average share price of the Company during a period of 30 days prior to the end of the vesting period. The resulting amount is capped at 400% of the respective allocation value and will be paid out as cash compensation.

The first allocation under the MB LTIP 2024+ was made during the second quarter of 2024 to the members of the Management Board and, during the third quarter of 2024 to a former member of the Management Board, retroactively as of March 1, 2024. An additional allocation was made as of June 1, 2024, when a new member joined the Management Board. For both allocations, the performance period commenced on January 1, 2024 and ends on December 31, 2026. Under the MB LTIP 2024+, 304,043 Performance Shares with a total fair value of €5,790 were allocated (thereof 266,497 Performance Shares with a total Fair Value of €5,100 to the members of the Management Board). This amount will be amortized over the vesting period, and will be revalued if the fair value changes. The weighted average fair value per Performance Share at the allocation date was €19.04 reflecting all market conditions such as the current target achievement for the Relative TSR target at the respective allocation date. For both allocations, the Supervisory Board decided to settle in cash. As such, the Company accounts for these allocations as a cash-settled share-based payment transaction.

The first allocation under the LTIP 2024+ was made as of July 29, 2024. The performance period commenced on January 1, 2024 and ends on December 31, 2026. Under the LTIP 2024+, 1,805,202 Performance Shares with a total fair value of €41,213 were allocated to members of the management boards of affiliated companies and managerial staff members. This amount will be amortized over the vesting period and will be revalued for changes in fair value. The weighted average fair value per Performance Share at the allocation date was €22.83 reflecting all market conditions such as the current target achievement for the Relative TSR target at the allocation date.

11.    Commitments and contingencies

Legal and regulatory matters

The Company is routinely involved in claims, lawsuits, regulatory and tax audits, investigations and other legal matters arising, for the most part, in the ordinary course of its business of providing health care services and products. Legal matters that the Company currently deems to be material or noteworthy are described below. The Company records its litigation reserves for certain legal proceedings and regulatory matters to the extent that the Company determines an unfavorable outcome is probable and the amount of loss can be reasonably estimated. For the other matters described below, the Company believes that the loss is not probable and/or the loss or range of possible losses cannot be reasonably estimated at this time. The outcome of litigation and other legal matters is always difficult to predict accurately and outcomes that are not consistent with the Company’s view of the merits can occur. The Company believes that it has valid defenses to the legal matters pending against it and is defending itself vigorously. Nevertheless, it is possible that the resolution of one or more of the legal matters currently pending or threatened could have a material adverse effect on its business, results of operations and financial condition.

Beginning in 2012, the Company received certain communications alleging conduct in countries outside the United States that might violate the U.S. Foreign Corrupt Practices Act (FCPA) or other anti-bribery laws. The Company conducted investigations with the assistance of outside counsel and, in a continuing dialogue, advised the Securities and Exchange Commission (SEC) and the United States Department of Justice (DOJ) about these investigations. The DOJ and the SEC also conducted their own investigations, in which the Company cooperated.

In the course of this dialogue, the Company identified and reported to the DOJ and the SEC, and took remedial actions with respect to, conduct that resulted in the DOJ and the SEC seeking monetary penalties including disgorgement of profits and other remedies. This conduct revolved principally around the Company’s products business in countries outside the United States. The Company’s remedial actions included separation of those employees responsible for the above-mentioned conduct. On March 29, 2019, the Company entered into a non-prosecution agreement (NPA) with the DOJ and a separate agreement with the SEC (SEC Order) intended to resolve fully and finally the U.S. government allegations against the Company arising from the investigations that included provisions for penalties and disgorgement, self-reporting obligations and retention of an independent compliance monitor whose certification of the Company’s implementation of an effective anti-corruption compliance program was finalized in January 2023.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.

In 2015, the Company self-reported certain legacy conduct with a potential nexus to Germany to the German prosecutor in the state of Hessen and continues to cooperate with government authorities in Germany in their review of the conduct that prompted the Company’s and United States government investigations. In September 2023, the Hessen prosecutor opened independent disgorgement proceedings against a German subsidiary of the Company relating to the aforementioned conduct in West Africa.

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

Since 2012, the Company has made significant investments in its compliance and financial controls and in its compliance, legal and financial organizations and is continuing to further implement its compliance program in connection with the resolution with the DOJ and SEC. The Company continues to react to post-FCPA review matters on various levels. The Company also continues to be fully committed to compliance with the FCPA and other applicable anti-bribery laws.

In August 2014, FMCH received a subpoena from the United States Attorney’s Office (USAO) for the District of Maryland inquiring into FMCH’s contractual arrangements with hospitals and physicians relating to the management of in-patient acute dialysis services. Thereafter, the USAO conducted an investigation, in which FMCH cooperated, and declined to intervene in the matter. After the United States District Court for Maryland unsealed the 2014 relator’s qui tam complaint that gave rise to the investigation, the relator served the complaint and proceeded on his own by filing an amended complaint, which FMCH moved to dismiss on multiple grounds. On October 5, 2021, on FMCH’s motion, the District Court for Maryland transferred the case to the United States District Court for Massachusetts. Flanagan v. Fresenius Medical Care Holdings, Inc., 1:21-cv-11627 (Flanagan). On December 5, 2022, the Massachusetts District Court granted FMCH’s motion and dismissed the case with prejudice. Relator has filed an appeal.

On October 19, 2023, a subsidiary of the Company was served with a complaint alleging that an employee was terminated in retaliation for raising concerns similar to those raised in the Flanagan litigation. Rowe v. Fresenius Medical Care Holdings, Inc., et al, 3:23-cv-00331, United States District Court for the Eastern District of Tennessee. FMCH will defend itself in the litigation.

In 2014, two New York physicians filed under seal a qui tam complaint in the United States District Court for the Eastern District of New York (Brooklyn), alleging violations of the False Claims Act relating to FMCH’s vascular access line of business. As previously disclosed, on October 6, 2015, the United States Attorney for the Eastern District of New York (Brooklyn) issued subpoenas to FMCH indicating its investigation is now seen to be related to the two relators’ complaint.

FMCH cooperated in the Brooklyn investigation, which was understood to be separate and distinct from settlements entered in 2015 in Connecticut, Florida and Rhode Island of allegations against American Access Care LLC (AAC) following FMCH’s 2011 acquisition of AAC.

On July 12, 2022, after the Court denied the USAO’s motions to renew the sealing of the relators’ complaint, the USAO filed a complaint-in-intervention. United States ex rel. Pepe and Sherman v. Fresenius Vascular Care, Inc. et al, 1:14-cv-3505. On October 3, 2023, the states of New York, New Jersey and Georgia filed a consolidated complaint-in-intervention. The United States’s, the three states’, and relators’ complaints allege that the defendants billed and received government payment for surgery that was not medically necessary. On October 31, 2024, the court granted FMCH’s motion to dismiss the relators’ complaint. FMCH is defending the allegations asserted in the litigation now proceeding.

On November 18, 2016, FMCH received a subpoena under the False Claims Act from the United States Attorney for the Eastern District of New York (Brooklyn) seeking documents and information relating to the operations of Shiel Medical Laboratory, Inc. (Shiel), which FMCH acquired in October 2013. FMCH advised the USAO that, under the asset sale provisions of its 2013 Shiel acquisition, it was not responsible for Shiel’s conduct prior to the date of the acquisition. On December 12, 2017, FMCH sold to Quest Diagnostics certain Shiel operations. Nonetheless, FMCH cooperated in the Brooklyn USAO’s investigation.

On June 14, 2022, the Brooklyn USAO declined to intervene on two relator complaints that underlay the investigation. The relators proceeded with litigation at their own expense against both Shiel and FMCH entities, alleging that the defendants wrongly caused government payers to pay for laboratory tests that were falsely or improperly invoiced and retaliated against relators for objecting to the alleged misconduct. Relator v. Shiel Medical Laboratory, 1:16-cv-01090 (E.D.N.Y. 2016); Relator v. Shiel Holdings, 1:17-cv-02732 (E.D.N.Y. 2017). FMCH reached a settlement in the Relator v. Shiel Holdings, 1:17-cv-02732 and the matter has been dismissed with prejudice. FMCH is defending allegations directed against entities it controls in the remaining matter.

In February 2022, the Company received a formal request for information from the Hessen Data Protection Authority (Hessischer Beauftragter für Datenschutz und Informationsfreiheit or HBDI). The information request relates to specific data processing functions of a few of the Company’s peritoneal dialysis devices. The Company is committed to complying with the HBDI’s request in good faith and cooperating with them, and it is working to provide the relevant information. Additionally, the Company is fully committed to safeguarding and protecting patients’ privacy as per applicable laws and privacy-by-design standards, as well as improving the devices continuously, considering technical, regulatory and privacy requirements.

On January 3, 2023, FMCH received a subpoena from the Attorney General for the District of Columbia related to the activities of the American Kidney Foundation (AKF) that is grounded in anti-trust concerns, including market allocation within the District of Columbia. FMCH’s relationship with AKF was the subject of a previously reported and resolved investigation by agencies of the United States and litigation against United Healthcare. FMCH is cooperating in the District of Columbia investigation.

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

On February 20, 2023, the Company received a statement of claim via the London Court of International Arbitration from its former distributor in Iraq. The Company terminated the distribution agreement in 2018. The former distributor seeks, inter alia, compensation for alleged wrongful termination and “quality issues,” as well as damages for lost profits. Some of the claims are not yet quantified by the former distributor as further information from the Company is requested. The Company has denied the allegations and filed a counterclaim for malperformance under the distribution agreement. The parties have exchanged several rounds of briefs and an oral hearing for the case will take place at the end of 2024. A decision of the arbitral tribunal is expected in 2025.

Four plaintiffs have filed two actions for contestation and annulment (Anfechtungs- und Nichtigkeitsklage) against the resolution adopted at the EGM of the Company on July 14, 2023 approving the Conversion. Based on the motions filed by the plaintiffs, it is unclear whether one of these actions is also directed against the resolution of the EGM on the election of the members of the supervisory board of Fresenius Medical Care AG. Due to these actions for contestation and annulment, the Conversion could not immediately be registered with the commercial register and become effective. This block on registration was overcome by clearance rulings (Freigabebeschlüssen) of the competent court of appeal on October 25, 2023 and on November 28, 2023 which decided in favor of the Company on all points. Thereafter, the Conversion was registered with the commercial register and thereby became effective as of November 30, 2023. Irrespective of the clearance rulings and the effectiveness of the Conversion, the proceedings regarding the actions for contestation and annulment will continue. The proceedings regarding the actions for contestation and annulment, which have been combined by the competent court in the meantime, may take one to several years until a ruling is rendered in the first instance, and another one to several years for each the second instance for the court of appeal and for the third instance for the German Federal Supreme Court if such further appeal to the German Federal Supreme Court is admitted. The actions for contestation and annulment may also be settled at any time by reaching an agreement with the plaintiffs. However, the Conversion will not be reversed under these proceedings, even if one or more of such actions were to be successful. Instead, the plaintiff’s remedies would be limited to damages in an amount which, in the Company’s view, is unlikely to be meaningful.

On April 5, 2024, Fresenius Medical Care Holdings, Inc. received two civil investigative demands (CIDs) from the U.S. Federal Trade Commission (FTC) indicating it was investigating whether FMCH, among others in the industry, has engaged in unfair or exclusionary conduct in violation of Section 5 of the FTC Act in the acquisition of Medical Director services or provision of dialysis services. The CIDs indicate they cover the period from January 1, 2016 to the present and generally request information related to FMCH’s dialysis services, including information related to restrictive covenants such as non-competes with physicians. The Company is cooperating with the investigation.

From time to time, the Company is a party to or may be threatened with other litigation or arbitration, claims or assessments arising in the ordinary course of its business. Management regularly analyzes current information including, as applicable, the Company’s defenses and insurance coverage and, as necessary, provides accruals for probable liabilities for the eventual disposition of these matters.

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

The Company, like other health care providers, insurance plans and suppliers, conducts its operations under intense government regulation and scrutiny. The Company must comply with regulations which relate to or govern the safety and efficacy of medical products and supplies, the marketing and distribution of such products, the operation of manufacturing facilities, laboratories, dialysis clinics and other health care facilities, and environmental and occupational health and safety. With respect to its development, manufacture, marketing and distribution of medical products, if such compliance is not maintained, the Company could be subject to significant adverse regulatory actions by the U.S. Food and Drug Administration (FDA) and comparable regulatory authorities outside the U.S. These regulatory actions could include warning letters or other enforcement notices from the FDA, and/or comparable foreign regulatory authority which may require the Company to expend significant time and resources in order to implement appropriate corrective actions. If the Company does not address matters raised in warning letters or other enforcement notices to the satisfaction of the FDA and/or comparable regulatory authorities outside the U.S., these regulatory authorities could take additional actions, including product recalls, injunctions against the distribution of products or operation of manufacturing plants, civil penalties, seizures of the Company’s products and/or criminal prosecution. FMCH completed remediation efforts with respect to a pending FDA warning letter issued in 2011 and is awaiting confirmation as to whether the letter is now closed. FMCH has responded to a second warning letter issued in December 2023 and has updated the FDA about continuing remediation efforts under that letter. The Company must also comply with the laws of the United States, including the federal Anti-Kickback Statute, the federal False Claims Act, the federal Stark Law, the federal Civil Monetary Penalties Law and the federal Foreign Corrupt Practices Act as well as other federal and state fraud and abuse laws. In Germany, where corporations are not subject to criminal law, management boards of companies must ensure business activities comply with the anti-corruption provisions of the criminal code, sections 331 et seq. (Strafgesetzbuch); breaches by individuals exercising commercial activity are subject to prosecution which can result in corporate fines and/or orders for the disgorgement of profit. Applicable laws or regulations may be amended, or enforcement agencies or courts may make interpretations that differ from the Company’s interpretations or the manner in which it conducts its business. Enforcement has become a high priority for the federal government and some states. In addition, the provisions of the False Claims Act authorizing payment of a portion of any recovery to the party bringing the suit encourage private plaintiffs to commence whistleblower actions. By virtue of this regulatory environment, the Company’s business activities and practices are subject to extensive review by regulatory authorities and private parties, and continuing audits, subpoenas, other inquiries, claims and litigation relating to the Company’s compliance with applicable laws and regulations. The Company may not always be aware that an inquiry or action has begun, particularly in the case of whistleblower actions, which are initially filed under court seal.

The Company operates many facilities and handles the personal data of its patients and beneficiaries throughout the United States and other parts of the world and engages with other business associates to help it carry out its health care activities. While the Company is committed to training its employees and business associates on applicable laws and procedures, investigating concerns and incidents in a timely manner and taking remedial and corrective action (including disciplinary action) as necessary, in such a widespread, global system it may be difficult to maintain the desired level of oversight and control over the thousands of individuals employed by the Company, its many affiliated companies and its service providers or business associates. The Company recognizes that the laws, regulations and interpretative guidance on data privacy are evolving along with potential litigation and enforcement risks, and it continues to review its processes to adapt to those changes. On occasion, the Company or its business associates may experience a breach under the Health Insurance Portability and Accountability Act Privacy Rule and Security Rules, the EU’s General Data Protection Regulation or other similar laws (Data Protection Laws), which may involve certain impermissible use, access, or disclosure of unsecured personal data pertaining to patients, employees, beneficiaries or others. On those occasions, the Company is committed to compliance with applicable notification and/or reporting requirements and to take appropriate remedial and corrective action. Included within the Company’s notification requirements are recent SEC rules that require the Company to report the occurrence of material cybersecurity incidents in a report on Form 6-K. Any such report could trigger litigation arising out of the incident. On September 29, 2023, Cardiovascular Consultants, Ltd. (CCL), a former subsidiary of the Company located in the U.S., became aware that some of its computer systems in the U.S. were affected by a security incident. The Company publicly disclosed information regarding this security breach in a Form 6-K furnished to the SEC, noting that the Company does not expect the incident to have a material impact on its financial condition or results of operations. Subsequently, Fresenius Vascular Care, Inc. d/b/a Azura Vascular Care (Azura), a wholly owned subsidiary of the Company located in the U.S., became aware that some of its files had been affected by the same security incident. There are two putative class action lawsuits pending in connection with this incident: one in Arizona state court against CCL and one in Pennsylvania federal court against Azura. Initially, there were four federal purported class action lawsuits filed against CCL in Arizona, but all four cases were voluntarily dismissed and consolidated with the pending state court case. Similarly, the two purported class action lawsuits filed against Azura were later consolidated. The complaints allege that CCL and Azura breached various duties relating to the safeguarding of confidential patient information and seek injunctive relief requiring that CCL and Azura implement various data protection processes and unspecified monetary damages. None of the actions has received class certification. Under the agreement for the sale of CCL, the Company retains responsibility for defending against these cases. In addition, the Company continues to cooperate with requests for information from the U.S. Department of Health & Human Services’ Office for Civil Rights and state regulatory agencies related to this matter.

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

The Company relies upon its management structure, regulatory and legal resources, and the effective operation of its compliance program to direct, manage and monitor the activities of its employees. On occasion, the Company may identify instances where employees or other agents deliberately, recklessly or inadvertently contravene the Company’s policies or violate applicable law and, in such instances, the Company will take appropriate corrective and/or disciplinary action. The actions of such persons may subject the Company and its subsidiaries to liability under the Anti-Kickback Statute, the Stark Law, the False Claims Act, Data Protection Laws, the Health Information Technology for Economic and Clinical Health Act and the FCPA, among other laws and comparable state laws or laws of other countries.

Physicians, hospitals and other participants in the health care industry are also subject to a large number of lawsuits alleging professional negligence, malpractice, product liability, worker’s compensation or related claims, many of which involve large claims and significant defense costs. The Company has been and is currently subject to these suits due to the nature of its business and expects that those types of lawsuits may continue. Although the Company maintains insurance at a level which it believes to be prudent, it cannot assure that the coverage limits will be adequate or that insurance will cover all asserted claims. A successful claim against the Company or any of its subsidiaries in excess of insurance coverage could have a material adverse effect upon it and the results of its operations. Any claims, regardless of their merit or eventual outcome, could have a material adverse effect on the Company’s reputation and business.

The Company has also had claims asserted against it and has had lawsuits filed against it relating to alleged patent infringements or businesses that it has acquired or divested. These claims and suits relate both to operation of the businesses and to acquisition and divestiture transactions. The Company has, when appropriate, asserted its own claims, and claims for indemnification. A successful claim against the Company or any of its subsidiaries could have a material adverse effect upon its business, financial condition, and the results of its operations. Any claims, regardless of their merit or eventual outcome, could have a material adverse effect on the Company’s reputation and business.

The Company is subject to ongoing and future tax audits in the U.S., Germany and other jurisdictions in the ordinary course of business. Tax authorities routinely pursue adjustments to the Company’s tax returns and disallowances of claimed tax deductions. When appropriate, the Company defends these adjustments and disallowances and asserts its own claims. A successful tax related claim against the Company or any of its subsidiaries could have a material adverse effect upon its business, financial condition and results of operations.

The German tax authorities re-qualified dividends received in connection with intercompany mandatorily redeemable preferred shares into fully taxable interest payments for the years 2006 until 2013, which could lead to additional tax payments in the mid-double-digit million range. Additionally, German tax authorities objected to the Company’s tax returns and took the position that income of one of the Company’s finance entities for 2017 and future periods should be subject to German Controlled Foreign Corporation taxation resulting in potential additional income tax payments in the very low end of triple-digit millions. In both cases, the Company will take any appropriate legal action to defend its position.

The Company is subject to residual value guarantees in certain lease contracts, primarily real estate contracts, for which it is the lessee in the amount of $987,031 (€881,596). As of September 30, 2024, the estimated fair market value of the underlying leased assets exceeded the related residual value guarantees and, therefore, the Company did not have any risk exposure relating to these guarantees.

Other than those individual contingent liabilities mentioned above, the current estimated amount of the Company’s other known individual contingent liabilities is immaterial.

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

12.    Financial instruments

The following tables show the carrying amounts and fair values of the Company’s financial instruments at September 30, 2024 and December 31, 2023:

Carrying amount and fair value of financial instruments

in € THOUS

September 30, 2024

 

Carrying amount

 

Fair value

    

Amortized

    

    

    

Not

    

    

    

    

    

 cost

    

FVPL

    

FVOCI

    

 classified

    

Total

    

Level 1

    

Level 2

    

Level 3

Cash and cash equivalents

1,170,984

199,906

1,370,890

199,906

Trade accounts and other receivables from unrelated parties(1)

3,073,467

86,350

3,159,817

Accounts receivable from related parties

34,752

34,752

Derivatives - cash flow hedging instruments

7,463

7,463

7,463

Derivatives - not designated as hedging instruments

23,440

23,440

23,440

Derivatives embedded in Virtual Power Purchase Agreements (vPPAs)

6,014

6,014

6,014

Equity investments

131,991

77,637

209,628

90,047

78,818

40,763

Debt securities

91,159

341,676

432,835

432,835

Other financial assets(2)

197,979

141,969

101,201

441,149

141,969

Other current and non-current assets

197,979

394,573

419,313

108,664

1,120,529

Financial assets

4,477,182

594,479

419,313

195,014

5,685,988

Accounts payable to unrelated parties(1)

751,509

751,509

Accounts payable to related parties

96,579

96,579

Short-term debt

103,925

103,925

Long-term debt

7,177,316

7,177,316

6,214,324

529,091

Lease liabilities

3,922,343

3,922,343

Derivatives - cash flow hedging instruments

5,425

5,425

5,425

Derivatives - not designated as hedging instruments

11,005

11,005

11,005

Derivatives embedded in vPPAs

23,576

23,576

23,576

Variable payments outstanding for acquisitions

9,692

9,692

9,692

Put option liabilities

1,310,907

1,310,907

1,310,907

Other financial liabilities(3)

798,276

798,276

Other current and non-current liabilities

798,276

44,273

1,316,332

2,158,881

Financial liabilities

8,927,605

44,273

5,238,675

14,210,553

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

Carrying amount and fair value of financial instruments

in € THOUS

December 31, 2023

 

Carrying amount

 

Fair value

Amortized

Not

    

cost

    

FVPL

    

FVOCI

    

classified

    

Total

    

Level 1

    

Level 2

    

Level 3

Cash and cash equivalents

 

1,205,030

198,462

1,403,492

198,462

Trade accounts and other receivables from unrelated parties

 

3,389,314

81,899

3,471,213

Accounts receivable from related parties

 

165,299

165,299

Derivatives - cash flow hedging instruments

 

1,990

1,990

1,990

Derivatives - not designated as hedging instruments

 

20,295

20,295

20,295

Equity investments

 

82,072

71,110

153,182

48,888

72,292

32,002

Debt securities

 

80,145

341,074

421,219

421,219

Other financial assets(2)

 

146,748

112,322

259,070

Other current and non-current assets

 

146,748

182,512

412,184

114,312

855,756

Financial assets

 

4,906,391

380,974

412,184

196,211

5,895,760

Accounts payable to unrelated parties

 

762,068

762,068

Accounts payable to related parties

 

123,081

123,081

Short-term debt

 

456,904

456,904

Long-term debt

 

7,447,562

7,447,562

5,972,767

767,328

Lease liabilities

4,145,946

4,145,946

Derivatives - cash flow hedging instruments

 

4,315

4,315

4,315

Derivatives - not designated as hedging instruments

 

4,890

4,890

4,890

Variable payments outstanding for acquisitions

 

35,751

35,751

35,751

Put option liabilities

 

1,372,008

1,372,008

1,372,008

Other financial liabilities(3)

 

974,252

974,252

Other current and non-current liabilities

 

974,252

40,641

1,376,323

2,391,216

Financial liabilities

 

9,763,867

40,641

5,522,269

15,326,777

(1)

In 2024, trade accounts and other receivables from unrelated parties as well as accounts payable to unrelated parties no longer include insurance and reinsurance contract receivables (liabilities) recorded in accordance with IFRS 17, Insurance Contracts, which are presented in note 5 as such receivables and liabilities are not within the scope of IFRS 7, Financial Instruments: Disclosures.

(2)

As of September 30, 2024 other financial assets primarily include receivables for royalty payments from one of the Company’s equity investments, lease receivables, receivables from sale of investments, deposits, guarantees, securities, notes receivable as well as vendor and supplier rebates. As of December 31, 2023 other financial assets primarily include lease receivables, deposits, guarantees, securities, receivables from sale of investments, vendor and supplier rebates as well as notes receivable.

(3)

As of September 30, 2024 and December 31, 2023, other financial liabilities primarily include receivable credit balances and goods and services received.

Derivative and non-derivative financial instruments are categorized in the following three-tier fair value hierarchy that reflects the significance of the inputs in making the measurements. Level 1 inputs are quoted prices for similar instruments in active markets. Level 2 is defined as using valuation models (i.e. mark-to-model) with input factors that are inputs other than quoted prices in active markets that are directly or indirectly observable. Level 3 is defined as using valuation models (i.e. mark-to-model) with input factors that are unobservable inputs for which little or no market data exists, therefore requiring the Company to develop its own assumptions. Fair value information is not provided for financial instruments, if the carrying amount is a reasonable estimate of fair value due to the relatively short period of maturity of these instruments. This includes cash and cash equivalents measured at amortized costs, trade accounts and other receivables from unrelated parties, accounts receivable from related parties, other financial assets as well as accounts payable to unrelated parties, accounts payable to related parties, short-term debt and other financial liabilities. Transfers between levels of the fair value hierarchy have not occurred as of September 30, 2024 or December 31, 2023. The Company accounts for transfers at the end of the reporting period.

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

Derivative financial instruments

In order to manage the risk of currency exchange rate and interest rate fluctuations, the Company enters into various hedging transactions by means of derivative instruments with highly rated financial institutions (generally investment grade) as authorized by the Company’s management. The Company primarily enters into foreign exchange forward contracts. In certain instances, the Company enters into derivative contracts that do not qualify for hedge accounting but are utilized for economic purposes (economic hedges). The Company does not use financial instruments for trading purposes.

In April 2024, the Company signed several vPPAs with wind and solar energy project developers in Germany and in the U.S. with terms of up to 15 years. The German vPPA contracts have been signed with two developers for a total expected annual electricity production of 124 gigawatt hours (GWh) which is equivalent to around 75% of the electricity consumption used by the Company in the European Union during 2023. The U.S. vPPA contract has been concluded with one developer and the forecasted annual electricity production amounts to 458 GWh which corresponds to around 60% of the electricity consumption used by the Company in the U.S. during 2023. The wind and solar parks are scheduled to become operational in 2024 and 2025. The Company does not have control or any other rights in relation to the usage of the energy-producing facilities. All contracts are designed as non-deliverable for the electricity produced and provide for the delivery of energy attribute certificates, commonly known in the U.S. and Germany as renewable energy certificates and guarantees of origin, respectively. All contracts are analyzed as physical host contracts to purchase the certificates and separable embedded electricity swaps to pay a fixed price for the electricity produced and to receive a variable spot energy price in the respective countries. The host contracts fulfill the “own-use” criteria in accordance with IFRS 9, Financial Instruments (IFRS 9). The derivatives embedded in the vPPAs are recognized separately at fair value through profit or loss. Embedded derivatives with positive fair values are recorded in other non-current financial assets within the consolidated balance sheets. Embedded derivatives with negative fair value are recorded in other non-current financial liabilities within the consolidated balance sheets. The fair value allocated to level 3 is derived from the present value of the expected cash flows from the derivatives. The main valuation parameters include significant unobservable inputs such as electricity future price curves and expected electricity production volumes. A change in the key valuation parameters as of September 30, 2024, would have affected the fair value of the derivatives embedded in vPPAs as follows:

Sensitivities of derivatives embedded in vPPAs to changes in unobservable inputs

in € THOUS

Change in expected electricity prices

Change in expected production volumes

10% increase

    

10% decrease

    

10% increase

    

10% decrease

26,519

(26,506)

 

(1,756)

 

1,756

Changes in the fair value of the derivatives embedded in the vPPAs are recognized in other operating income or other operating expense in the consolidated statements of income. Due to the volatile nature of such instruments which may be considered to be speculative, it is difficult to accurately predict what impact the volatility of unobservable inputs, such as changes in expected energy prices or production volumes, may have on the valuation of such instruments in the future. The estimated fair values of these derivative instruments may fluctuate significantly from quarter to quarter and the price at which these derivatives may ultimately be settled could vary significantly from the Company’s current estimates, depending upon market conditions.

The following table provides a reconciliation of derivatives embedded in the vPPAs at September 30, 2024:

Reconciliation of derivatives embedded in vPPAs

in € THOUS

    

2024

Derivatives embedded in

Derivatives embedded in

the vPPAs - Assets

the vPPAs - Liabilities

Beginning balance at January 1,

 

 

Settlements

 

 

Gain (loss) recognized in profit or loss (1)

 

6,014

 

(24,279)

Foreign currency translation and other changes

 

 

703

Ending balance at September 30,

 

6,014

 

(23,576)

(1)Includes realized and unrealized gains / losses.

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

Non-derivative financial instruments

The significant methods and assumptions used for the classification and measurement of non-derivative financial instruments are as follows:

The Company assessed its business models and the cash flow characteristics of its financial assets. The vast majority of the non-derivative financial assets are held in order to collect contractual cash flows. The contractual terms of the financial assets allow the conclusion that the cash flows represent payment of principal and interest only. Trade accounts and other receivables from unrelated parties (including receivables related to the former Accounts Receivable Facility, see note 8), Accounts receivable from related parties and Other financial assets are consequently measured at amortized cost.

Cash and cash equivalents are comprised of cash funds and other short-term investments. Cash funds are measured at amortized cost. Short-term investments are highly liquid and readily convertible to known amounts of cash. Short-term investments are measured at fair value through profit or loss (FVPL). The risk of changes in fair value is insignificant.

Equity investments are not held for trading. At initial recognition the Company elected, on an instrument-by-instrument basis, to represent subsequent changes in the fair value of individual strategic investments in other comprehensive income. If equity instruments are quoted in an active market, the fair value is based on price quotations at the period-end-date. As necessary, the Company engages external valuation firms to assist in determining the fair value of Level 3 equity investments. The external valuation uses a discounted cash flow model, which includes significant unobservable inputs such as investment specific forecasted financial statements and weighted average cost of capital, that reflects current market assessments as well as a terminal growth rate.

The majority of the debt securities are held within a business model whose objective is achieving both contractual cash flows and selling securities. The standard coupon bonds give rise on specified dates to cash flows that are solely payments of principal and interest on the outstanding principal amount. Subsequently, these financial assets have been classified as fair value through other comprehensive income (FVOCI). The smaller part of debt securities does not give rise to cash flows that are solely payments of principal and interest. Consequently, these securities are measured at FVPL. In general, most of the debt securities are quoted in an active market.

Long-term debt is initially recognized at its fair value and subsequently measured at amortized cost. The fair values of major long-term debt are calculated on the basis of market information. Liabilities for which market quotes are available are measured using these quotes. The fair values of the other long-term debt are calculated at the present value of the respective future cash flows. To determine these present values, the prevailing interest rates and credit spreads for the Company as of the balance sheet date are used.

Variable payments outstanding for acquisitions are recognized at their fair value. The estimation of individual fair values is based on the key inputs of the arrangement that determine the future contingent payment as well as the Company’s expectation of these factors. The Company assesses the likelihood and timing of achieving the relevant objectives. The underlying assumptions are reviewed regularly.

Put option liabilities are recognized at the present value of the exercise price of the option. The exercise price of the option is generally based on fair value and, in certain limited instances, might contain a fixed floor price. The methodology the Company uses to estimate the fair values assumes the greater of net book value or a multiple of earnings, based on historical earnings, development stage of the underlying business and other factors. From time to time the Company engages an external valuation firm to assist in the valuation of certain put options. The external valuation assists the Company in estimating the fair values using a combination of discounted cash flows and a multiple of earnings and/or revenue. Under those limited circumstances in which the put option might contain a fixed floor price, the external valuation firm may assist the Company with the valuation by performing a Monte Carlo Simulation analysis to simulate the exercise price. The put option liabilities are discounted at a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the liability. The estimated fair values of these put options can also fluctuate, and the discounted cash flows as well as the implicit multiple of earnings and/or revenue at which these obligations may ultimately be settled could vary significantly from the Company’s current estimates depending upon market conditions. For the purpose of analyzing the impact of changes in unobservable inputs on the fair value measurement of put option liabilities, the Company assumes an increase on earnings (or enterprise value, where applicable) of 10% compared to the actual estimation as of the balance sheet date. The corresponding increase in fair value of €92,021 is then compared to the total liabilities and the shareholder’s equity of the Company. This analysis shows that an increase of 10% in the relevant earnings (or enterprise value, where applicable) would have an effect of less than 1% on the total liabilities and less than 1% on the shareholder’s equity of the Company.

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Table of Contents

FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

The following table provides a reconciliation of Level 3 financial instruments, excluding vPPAs as disclosed above, at September 30, 2024 and December 31, 2023:

Reconciliation from beginning to ending balance of level 3 financial instruments

in € THOUS

    

2024

    

2023

    

Variable

    

Other

    

Variable

    

    

payments

financial

    

payments

outstanding

assets

    

outstanding

Equity

for

Put option

measured at

Equity

for

Put option

    

investments

    

acquisitions

    

liabilities

    

FVPL (1)

    

investments

    

acquisitions

    

liabilities

Beginning balance at January 1,

 

32,002

35,751

1,372,008

42,793

37,846

1,468,517

Increase

1,900

66

5,051

41,207

4,833

5,232

31,050

Decrease

(23,465)

(10,971)

(2,291)

(3,603)

(42,490)

Reclassifications

90,457

(2)

Gain / loss recognized in profit or loss(3)

7,552

(2,028)

14,657

(14,340)

(3,366)

Gain / loss recognized in equity

 

(40,534)

(28,034)

Foreign currency translation and other changes

(691)

(632)

(14,647)

(2,061)

(1,284)

(358)

(57,035)

Ending balance at September 30, and December 31,

40,763

9,692

1,310,907

141,969

32,002

35,751

1,372,008

(1) Other financial assets measured at FVPL consist of receivables from licensing agreements and receivables from sale of investments.
(2) Receivables for royalty payments from one of the Company’s equity investments were previously recorded as a non-financial asset and were revised as of March 31, 2024.
(3) Includes realized and unrealized gains / losses.

13.    Segment and corporate information

The Company’s operating segments are determined based upon how the Company manages its businesses and allocates resources with responsibilities by products and services and is aligned to the financial information that is presented on a quarterly basis to the chief operating decision maker. The Care Enablement segment is primarily engaged in the distribution of products and equipment, including R&D, manufacturing, supply chain and commercial operations, as well as supporting functions, such as regulatory and quality management. The Care Delivery segment is primarily engaged in providing health care services for the treatment of chronic kidney disease, ESRD and other extracorporeal therapies, including value and risk-based care programs. Care Delivery also includes the pharmaceutical products business and the income from equity method investees related to the sale of certain renal pharmaceuticals from Vifor Fresenius Medical Care Renal Pharma Ltd., which are used in the Company’s clinics to provide health care services to its patients.

The Company’s Global Medical Office, which seeks to optimize medical treatments and clinical processes within the Company and supports both Care Delivery and Care Enablement, is centrally managed and its profit and loss are allocated to the segments. Similarly, the Company allocates costs related primarily to headquarters’ overhead charges, including accounting and finance as well as certain human resources, legal and IT costs, as the Company believes that these costs are attributable to the segments and used in the allocation of resources to Care Delivery and Care Enablement. These costs are allocated at budgeted amounts, with the difference between budgeted and actual figures recorded at the corporate level. However, certain costs, which relate mainly to shareholder activities, management activities, global internal audit and the remeasurement of certain investments and, in the third quarter of 2024, vPPAs are not allocated to a segment but are accounted for as corporate expenses. These activities do not fulfill the definition of a segment according to IFRS 8, Operating Segments and are reported separately as Corporate (Corporate). Financing is a corporate function which is not controlled by the operating segments. Therefore, the Company does not include interest expense relating to financing as a segment measurement. In addition, the Company does not include income taxes as it believes taxes are outside the segments’ control.

Management evaluates each segment using measures that reflect all of the segment’s controllable revenues and expenses. With respect to the performance of business operations, management believes that the most appropriate measures are revenue and operating income. The Company transfers products between segments at fair market value. The associated internal revenues and expenses and any remaining internally generated profit or loss for the product transfers are recorded within the operating segments initially, are eliminated upon consolidation and are included within “Inter-segment eliminations.” Capital expenditures for production are based on the expected demand of the segments and consolidated profitability considerations.

54

Table of Contents

FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

Information pertaining to the Company’s segment and Corporate activities for the three and nine months ended September 30, 2024 and 2023 is set forth below:

Segment and corporate information

in € THOUS

    

    

    

    

    

 

 

Care

 

Total

 

Inter-segment

    

Care Delivery

    

Enablement

    

Segment

    

eliminations

    

Corporate

    

Total

Three months ended September 30, 2024

 

  

 

  

 

  

 

  

 

  

 

  

Revenue from health care services(1)

3,292,628

3,292,628

3,292,628

Revenue from health care products(1)

47,864

974,018

1,021,882

1,021,882

Revenue from contracts with customers(1)

3,340,492

974,018

4,314,510

4,314,510

Revenue from insurance contracts(1)

429,946

429,946

429,946

Revenue from lease contracts(1)

15,706

15,706

15,706

Revenue from external customers

3,770,438

989,724

4,760,162

4,760,162

Inter-segment revenue

369,683

369,683

(369,683)

Revenue

3,770,438

1,359,407

5,129,845

(369,683)

4,760,162

Operating income (loss)

419,447

60,802

480,249

(4,205)

(13,348)

462,696

Interest

(82,170)

Income before income taxes

380,526

Depreciation and amortization

(254,304)

(111,015)

(365,319)

10,787

(17,561)

(372,093)

Impairment loss

7,712

(1,413)

6,299

6,299

Income (loss) from equity method investees

41,248

41,248

41,248

Additions of property, plant and equipment, intangible assets and right-of-use assets (1)

215,996

118,266

334,262

(12,063)

9,133

331,332

Three months ended September 30, 2023

 

Revenue from health care services(1)

3,570,987

3,570,987

3,570,987

Revenue from health care products(1)

46,899

941,660

988,559

988,559

Revenue from contracts with customers(1)

3,617,886

941,660

4,559,546

4,559,546

Revenue from insurance contracts(1)

356,382

356,382

356,382

Revenue from lease contracts(1)

20,309

20,309

20,309

Revenue from external customers

3,974,268

961,969

4,936,237

4,936,237

Inter-segment revenue

368,054

368,054

(368,054)

Revenue

3,974,268

1,330,023

5,304,291

(368,054)

4,936,237

Operating income (loss)

332,143

(1,261)

330,882

1,358

(8,012)

324,228

Interest

(88,717)

Income before income taxes

235,511

Depreciation and amortization

(273,295)

(113,424)

(386,719)

11,399

(17,318)

(392,638)

Impairment loss

(55,212)

(6,086)

(61,298)

(96)

(61,394)

Income (loss) from equity method investees

20,337

2,298

22,635

22,635

Additions of property, plant and equipment, intangible assets and right- of-use assets (1)

163,945

88,018

251,963

(6,891)

5,454

250,526

(1)

These line items are included to comply with requirements under IFRS 8 and IFRS 15 or are provided on a voluntary basis, but not included in the information regularly reviewed by the chief operating decision maker. Additionally, the Company has adjusted the prior period financial information in order to include additional contracts identified during the course of the year ended December 31, 2023 which were subject to certain disclosures in accordance with IFRS 17.

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FRESENIUS MEDICAL CARE AG

Notes to the interim consolidated financial statements

(unaudited)

(in THOUS, except share and per share data)

Segment and corporate information (continued)

in € THOUS

    

    

Care

    

    

Inter-segment

    

    

Care Delivery

Enablement

Total Segment

eliminations

Corporate

Total

Nine months ended September 30, 2024

 

  

 

  

 

  

 

  

 

  

 

  

Revenue from health care services(1)

 

9,986,979

9,986,979

9,986,979

Revenue from health care products(1)

 

136,916

2,863,733

3,000,649

3,000,649

Revenue from contracts with customers(1)

 

10,123,895

2,863,733

12,987,628

12,987,628

Revenue from insurance contracts(1)

 

1,205,997

1,205,997

1,205,997

Revenue from lease contracts(1)

 

57,497

57,497

57,497

Revenue from external customers

 

11,329,892

2,921,230

14,251,122

14,251,122

Inter-segment revenue

 

1,098,605

1,098,605

(1,098,605)

Revenue

 

11,329,892

4,019,835

15,349,727

(1,098,605)

14,251,122

Operating income (loss)

 

936,779

196,296

1,133,075

(8,680)

9,103

1,133,498

Interest

 

(255,688)

Income before income taxes

 

877,810

Depreciation and amortization

 

(781,558)

(340,736)

(1,122,294)

32,286

(53,582)

(1,143,590)

Impairment loss

 

(104,537)

(17,129)

(121,666)

(121,666)

Income (loss) from equity method investees

 

102,730

102,730

102,730

Total assets(1)

 

43,296,775

15,501,825

58,798,600

(37,315,733)

11,027,934

32,510,801

thereof investment in equity method investees(1)

 

690,794

690,794

690,794

Additions of property, plant and equipment, intangible assets and right-of-use assets(1)

 

622,331

298,903

921,234

(39,512)

35,260

916,982

Nine months ended September 30, 2023

 

  

 

  

 

  

 

  

 

  

 

  

Revenue from health care services(1)

 

10,541,719

 

 

10,541,719

 

 

 

10,541,719

Revenue from health care products(1)

 

133,629

 

2,818,963

 

2,952,592

 

 

 

2,952,592

Revenue from contracts with customers(1)

 

10,675,348

 

2,818,963

 

13,494,311

 

 

 

13,494,311

Revenue from insurance contracts(1)

 

927,009

 

 

927,009

 

 

 

927,009

Revenue from lease contracts(1)

 

 

44,411

 

44,411

 

 

 

44,411

Revenue from external customers

 

11,602,357

 

2,863,374

 

14,465,731

 

 

 

14,465,731

Inter-segment revenue

 

 

1,101,918

 

1,101,918

 

(1,101,918)

 

 

Revenue

 

11,602,357

 

3,965,292

 

15,567,649

 

(1,101,918)

 

 

14,465,731

Operating income (loss)

 

1,000,882

 

(24,200)

 

976,682

 

(11,774)

 

(23,116)

 

941,792

Interest

 

 

 

 

 

 

(251,832)

Income before income taxes

 

 

 

 

 

 

689,960

Depreciation and amortization

 

(844,550)

 

(343,897)

 

(1,188,447)

 

30,981

 

(52,841)

 

(1,210,307)

Impairment loss

 

(77,317)

 

(38,317)

 

(115,634)

 

 

(96)

 

(115,730)

Income (loss) from equity method investees

 

91,988

 

6,431

 

98,419

 

 

 

98,419

Total assets(1)

 

42,737,970

 

15,342,444

 

58,080,414

 

(32,212,530)

 

9,766,812

 

35,634,696

thereof investment in equity method investees(1)

 

366,925

 

338,177

 

705,102

 

 

 

705,102

Additions of property, plant and equipment, intangible assets and right-of-use assets(1)

 

567,037

 

304,901

 

871,938

 

(24,155)

 

29,047

 

876,830

(1)

These line items are included to comply with requirements under IFRS 8 and IFRS 15 or are provided on a voluntary basis, but not included in the information regularly reviewed by the chief operating decision maker. Additionally, the Company has adjusted the prior period financial information in order to include additional contracts identified during the course of the year ended December 31, 2023 which were subject to certain disclosures in accordance with IFRS 17.

14.    Events occurring after the balance sheet date

On October 15, 2024, Fresenius Medical Care US Finance II, Inc. redeemed $400,000 aggregate principal amount of bonds (€314,046 as of the date of issuance on October 29, 2014) at maturity.

No other significant events have taken place subsequent to the balance sheet date September 30, 2024 that have a material impact on the key figures and earnings presented. Currently, there are no significant changes in the Company’s structure, management, legal form or personnel.

56

Table of Contents

Quantitative and qualitative disclosures about market risk

The information in note 26 of the notes to the consolidated financial statements included in the Company’s Annual Report on Form 20-F for the year ended December 31, 2023 and in note 12 of the notes to the consolidated financial statements (unaudited) included in this report, is incorporated by this reference.

57

Table of Contents

Controls and procedures

The Company is a “foreign private issuer” within the meaning of Rule 3b-4(c) under the Securities Exchange Act of 1934, as amended (the Exchange Act). As such, the Company is not required to file quarterly reports with the Securities and Exchange Commission (the Commission) and is required to provide an evaluation of the effectiveness of its disclosure controls and procedures, to disclose significant changes in its internal control over financial reporting and to provide certifications of its Chief Executive Officer and Chief Financial Officer under Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 only in its Annual Report on Form 20-F. The Company furnishes quarterly financial information to the Commission and such certifications under cover of Form 6-K on a voluntary basis. While the Company currently expects to adhere to such reporting processes, there can be no assurance that the Company will continue to do so.

In connection with such voluntary reporting, the Company’s management, including the Chief Executive Officer and the Chief Financial Officer of the Company, has conducted an evaluation of the effectiveness of the Company’s disclosure controls and procedures as of the end of the period covered by this report, of the type contemplated by Securities Exchange Act Rule 13a-15. Based on that evaluation, the Chief Executive Officer and the Chief Financial Officer concluded in connection with the furnishing of this report, that the Company’s disclosure controls and procedures are designed to ensure that the information the Company is required to disclose in the reports filed or furnished under the Act is recorded, processed, summarized and reported within the time periods specified in the Commission’s rules and forms and are effective to ensure that the information the Company is required to disclose in its reports is accumulated and communicated to the Management Board, including the Chief Executive Officer and the Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure. During the past fiscal quarter, there have been no significant changes in internal controls, or in factors that could significantly affect internal controls.

58

Table of Contents

OTHER INFORMATION

Legal proceedings

The information in note 11 of the notes to the consolidated financial statements (unaudited), presented elsewhere in this report, is incorporated by this reference.

59

Table of Contents

Exhibits

The following exhibits are filed within this Report:

Exhibit No.

    

10.4

Fresenius Medical Care AG Long-Term Incentive Plan 2024+ (filed herewith).

31.1

Certification of Chief Executive Officer and Chair of the Management Board of the Company Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2

Certification of Chief Financial Officer and member of the Management Board of the Company Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1

Certification of Chief Executive Officer and Chair of the Management Board of the Company Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (this exhibit accompanies this report as required by the Sarbanes-Oxley Act of 2002 and is not to be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended).

32.2

Certification of Chief Financial Officer and member of the Management Board of the Company Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (this exhibit accompanies this report as required by the Sarbanes-Oxley Act of 2002 and is not to be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended).

101

The following financial statements as of and for the three- and nine-month periods ended September 30, 2024 from FME AGs Report on Form 6-K for the month of November 2024, formatted in iXBRL (Inline eXtensible Business Reporting Language) and included in the body of this report: (i) Consolidated Statements of Income, (ii) Consolidated Statements of Comprehensive Income, (iii) Consolidated Balance Sheets, (iv) Consolidated Statements of Cash Flows, (v) Consolidated Statements of Shareholders’ Equity and (vi) Notes to the Consolidated Financial Statements.

60

Table of Contents

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

DATE: November 5, 2024

FRESENIUS MEDICAL CARE AG

By:

/s/ HELEN GIZA

Name:

Helen Giza

Title:

Chief Executive Officer and Chair of the Management Board

By:

/s/ MARTIN FISCHER

Name:

Martin Fischer

Title:

Chief Financial Officer and member of the Management Board

61

EX-10.4 2 fms-20240930xex10d4.htm EXHIBIT 10.4

Exhibit 10.4

Non-MB Long-Term Incentive Plan 2024+ and July Grant 2024”

Annex I to Voting Letter

“Non-MB Long-Term Incentive Plan 2024+ and July Grant 2024”

Management Board of Fresenius Medical Care AG

Fresenius Medical Care AG

Long-Term Incentive Plan 2024+

Page 1/19


TABLE OF CONTENTS

CLAUSE

PAGE

1.

PREAMBLE AND PURPOSE

3

2.

ELIGIBILITY TO RECEIVE PERFORMANCE SHARES

3

3.

PERFORMANCE SHARES

4

4.

GRANT OF PERFORMANCE SHARES

4

5.

PERFORMANCE TARGETS, TARGET ACHIEVEMENT AND PERFORMANCE PERIOD / EXHIBITS

5

6.

VESTING OF PERFORMANCE SHARES

7

7.

SETTLEMENT OF PERFORMANCE SHARES/CAP ON PAYMENTS

8

8.

PERFORMANCE SHARES IN SPECIAL CASES

10

9.

NO TRANSFERABILITY / FORFEITURE

12

10.

TAXES, CONTRIBUTIONS AND OTHER EXPENSES

12

11.

PROCEDURE, ENDING AND ADJUSTMENT OF THE PLAN

13

12.

LIABILITY RISKS, EXCHANGE RISKS AND TAX RISKS

15

13.

TERM OF THE PLAN

15

14.

MISCELLANEOUS PROVISIONS

15

15.

DEFINITIONS

16

Page 2/19


1.

Preamble and Purpose

1.1

The management board of the Company (the Management Board) has decided to establish the Fresenius Medical Care Long-Term Incentive Plan 2024+ (the Plan) to enable the granting of virtual performance-based shares of the Company (the Performance Shares) to the members of the management boards of Affiliated Companies and to managerial staff members (Führungskräfte) of the Company and of Affiliated Companies (each a Participant) as a long-term compensation component. The Plan succeeds the Fresenius Medical Care Long Term Incentive Plan 2022+ and applies to Performance Shares granted from fiscal year 2024 onwards.

1.2

The Performance Shares may entitle the Participants to receive a cash payment from the Company subject to the following provisions. The Plan contains the requirements, terms and conditions as well as the procedures for the grant and settlement of Performance Shares as well as the potential reversal of such settlement (the Plan Conditions).

1.3

The purpose of this Plan is to align the interests of the Participants with the interests of the Company and its shareholders in encouraging the long-term and sustainable growth of the Company. This Plan offers the Participants a competitive and transparent compensation component which combines the long-term benefits for the Participants with the sustained success of the Company.

1.4

Capitalized terms used in this Plan but not defined in the body of the Plan are defined in Clause 15.

2.

Eligibility to receive Performance Shares

2.1

The eligibility of Participants to receive Performance Shares will be finally determined by the Management Board, in each case – i.e., for each grant – in accordance with the terms of this Plan.

2.2

This Plan does not establish and should not be read or construed so as to establish a legal right to receive Performance Shares. Neither the status or possible status of an employee or a member of the management within FME Group as Participant nor the fact that a Participant was granted Performance Shares or any other long-term compensation components in previous periods shall be interpreted as an obligation that Performance Shares shall be granted or, if granted, shall continue to be granted in the future. In particular, granting Performance Shares does not constitute an

Page 3/19


operational practice (betriebliche Übung), even if Performance Shares or any other long-term compensation components have been granted for several successive years.

3.

Performance Shares

3.1

Performance Shares issued under the Plan may entitle a Participant to receive a cash payment from the Company or from an Affiliated Company in accordance with the Plan Conditions.

3.2

A Performance Share is a non-equity, cash-settled virtual compensation instrument. The Performance Shares will not be evidenced by certificates. Without limiting the generality of the foregoing, nothing in this Plan, in particular any grant of Performance Shares, the achievement of any Performance Target for any Performance Shares or the vesting of any Performance Shares, shall entitle any Participant to receive shares of the Company or confer upon or be interpreted as conferring upon any Participant any right or interest whatsoever as a shareholder of the Company or of any other member of the FME Group including, but not limited to, the right to vote at, to receive notice of, or to attend any meeting of shareholders of any member of the FME Group or any other proceedings of any such FME Group member, or the right to dividends or other distributions.

4.

Grant of Performance Shares

4.1

Subject to final determination by the Management Board the Participants will be granted Performance Shares as of 1 January 2024. Performance Share grants may be made twice a year with effect as of the last Monday in July and the first Monday in December (each a Grant Date). The Grant Date can, however, be subject to deviation in case of objective grounds (sachliche Gründe), as may be decided by the Management Board.

4.2

Each Participant will be awarded an individual Grant Value (the Grant Value) in the currency in which the Participant receives his/her base salary (the Grant Currency) from the Company or an Affiliated Company at the time when the Grant Value is determined by the Company. To determine the number of Performance Shares to be granted to the respective Participant (the Number of Granted Performance Shares) the Grant Value denominated in the Grant Currency will then be converted into Euro based on the average Foreign Currency Exchange Rates effectively established over a period of 30 (thirty) calendar days prior to each Grant Date (the FX Rates at Grant Date) and divided by the value per Performance Share at Grant Date. The value per Performance Share will be determined in accordance with IFRS 2 on each respective

Page 4/19


Grant Date, denominated in Euro, and considering the average Stock Exchange Price effectively established over a period of 30 (thirty) calendar days prior to such Grant Date; if a Performance Target (as defined in Clause 5.1) is considered a “market condition” within the meaning of IFRS 2, a target achievement of 100% shall be assumed for such Performance Target for the period starting from the beginning of the Performance Period to the Grant Date. For the avoidance of doubt, the Number of Granted Performance Shares will be rounded up or down to the next closest integer number (e.g., 124.54 will result in 125). The amount of the individual Grant Value shall be determined on the basis of the Participant’s individual performance and the Participant’s responsibilities within FME Group. This determination will be made for each grant at the Management Board’s discretion.

4.3

The grant of Performance Shares will be made without any payment by the Participant.

4.4

The grant shall be communicated to the Participants in text form, i.e., by mail, email or via an online platform. No grant shall be effective unless and until it is communicated to the Participant.

5.

Performance Targets, Target Achievement and Performance Period / Exhibits

5.1

Based on the degree of attainment of pre-determined performance targets (the Performance Targets), the number of Performance Shares attributable to each Participant to vest (the Number of Performance Shares to Vest) can vary from 0% of the Number of Granted Performance Shares to a pre-defined multiple thereof. The Performance Targets and their respective weighting are set out in the respective Exhibits to this Plan, as applicable to the Performance Shares for a particular fiscal year.

5.2

The achievement of the respective Performance Targets in relation to each grant of Performance Shares is measured over a multi-year performance period (the Performance Period).

5.3

The achievement of the Performance Targets for each grant of Performance Shares is determined at the end of the respective Performance Period, as set out in the respective Exhibits to this Plan, as applicable to the Performance Shares for a particular fiscal year, and as soon as the Company’s audited figures for the last year of the respective Performance Period are available (each a Performance Target Achievement).

5.4

The overall target achievement (the Overall Target Achievement) for each grant of Performance Shares is calculated on the basis of the Performance Target

Page 5/19


Achievements, taking into account the weighting applicable to each Performance Target as set out in the respective Exhibits to this Plan, as applicable to the Performance Shares for a particular fiscal year.

Example:

Graphic

5.5

The Number of Performance Shares to Vest is calculated by multiplying the Number of Granted Performance Shares with the Overall Target Achievement.

Example:

Graphic

5.6

The Performance Target Achievement shall be rounded up or down using commercial rounding to the second decimal place of the percentage figure (e.g., 98.1523% will result in 98.15%). The Overall Target Achievement shall be rounded up or down using commercial rounding to the next integer number in percentage points (e.g., 128.352%

Page 6/19


will result in 128%). Similarly, the Number of Performance Shares to Vest shall be rounded up or down using commercial rounding to the next integer number (e.g., 46,437.5 will result in 46,438).

5.7

The definition of, and the degree of attainment for, the respective Performance Targets and the term of the Performance Period are specified in the exhibits to this Plan, as amended from time to time, (the Exhibits) that will be communicated to the Participants for each Performance Period in text form, i.e., by mail, email or via an online platform.

6.

Vesting of Performance Shares

6.1

Vesting Date

Subject to the terms of this Plan, the Performance Shares will vest on the date of the third anniversary of the respective Grant Date (the Vesting Date). Exceptions or modifications may apply in special cases described in Clause 8.

6.2

Additional Vesting Conditions

Subject to the terms of this Plan, the Performance Shares furthermore will vest only on the conditions and insofar as

(a)

the Participant continuously has been in an employment or service relationship with FME Group from the Grant Date to the Vesting Date (the Service Condition). In case the Service Condition has not been fulfilled, the respective Performance Shares are forfeited on the date on which the employment or service relationship of the Participant with FME Group ends. Exceptions or modifications may apply in special cases described in Clause 8 hereinafter; and

(b)

in relation to or in connection with his/her employment or service relationship with FME Group, the Participant has not committed and/or engaged in any relevant violation of laws or regulations or applicable other rules, e.g., policies and standards of FME Group (the Compliance Violations). If FME determines a Compliance Violation, the Management Board has the authority, within its reasonable discretion and in due consideration particularly of the nature and the severity of the Compliance Violation, to decide upon the forfeiture, in whole or in part, of the Performance Shares granted to such Participant. FME shall notify the Participant of the forfeited Performance Shares in a documented form, i.e., by mail, email or via an online platform.

Page 7/19


In addition, with respect to Participants qualifying as “executive officers” within the meaning of the Policy (as defined in Clause 7.4), the Number of Performance Shares to Vest of any Participant may be reduced in connection with, or to effectuate, the Company’s recovery of excess Incentive-based Compensation in accordance with the Policy and Clause 7.4 of the Plan.

7.

Settlement of Performance Shares/Cap on Payments

7.1

One Performance Share carries the entitlement to receive a cash equivalent of the average Stock Exchange Price effectively established over a period of 30 (thirty) calendar days prior to the Vesting Date (the Performance Shares Proceeds). Such cash payment will be made on the Vesting Date, or as soon thereafter as is reasonably practicable. The Participant shall be informed of the Number of Performance Shares to Vest and the corresponding cash payment in text form, i.e., by mail, email or via an online platform.

Example for a Participant to be paid in Euro:

Graphic

7.2

Performance Shares Proceeds are paid to the Participant in the currency in which the Participant receives his/her base salary from the Company or an Affiliated Company in the month of the Vesting Date (the Settlement Currency). For this purpose, the respective FX Rates at Grant Date according to Clause 4.2 shall be applied. The purpose of applying the FX Rates at Grant Date is to mitigate exposure to exchange rate fluctuations between the Grant Date and the Vesting Date. In cases of Extraordinary Developments, the Management Board is entitled to adjust the FX Rates at Grant Date according to Clause 4.2 to the benefit of the Participants and to waive the cap for the payment of the Performance Shares Proceeds pursuant to Clause 7.3.

7.3

Following and based on the determination of the Number of Performance Shares to Vest, each Participant shall receive the Performance Shares Proceeds. The amount of Performance Shares Proceeds paid to the Participant is capped in total at an

Page 8/19


amount equaling 400% of the Grant Value received by the Participant; any exceeding amounts of Performance Shares Proceeds will be forfeited without substitution. Clause 10 and Clause 11.2 remain unaffected.

7.4

Payment of Performance Shares Proceeds to the Participant is made in each case with the proviso (condition subsequent) that with respect to the Participant a Compliance Violation within the meaning of, and pursuant to, Clause 6.2(b) has not been determined conclusively within a period of three years from the day of the payment of the Performance Shares Proceeds. Clause 11.4 shall remain unaffected.

7.5

Application of Incentive-based Compensation Recovery Policy

(a)

In addition to, and not in derogation of, Clauses 7.4 and 11.4, grants of Performance Shares pursuant to this Plan shall be subject to recovery by the Company in accordance with the Fresenius Medical Care Global Incentive-Based Compensation Recovery Policy (the Policy), as the same may be amended, modified or amended and restated from time to time.

(b)

Notwithstanding the provisions of Clause 7.5(a), no portion of the Number of Performance Shares to Vest attributable to a Participant by virtue of the Company’s achievement of non-financial performance targets in whole or in part, for any fiscal year of the Company during the applicable Performance Period or for the applicable Performance Period as a whole (as determined in accordance with the weighting criteria set forth in Clauses 5.3 and 5.4), shall constitute Incentive-based Compensation or be subject to recovery by the Company under the Policy.

(c)

By acceptance of an award of a Grant Value pursuant to this Plan, a Participant acknowledges (i) receipt of the Policy and (ii) that except as provided in Clause 7.5(b), Performance Shares constitute Incentive-based Compensation, and agrees that in the event the Company is required to recover any portion of such Performance Shares Proceeds as excess Incentive-based Compensation in accordance with the Policy, such recovery may be effected by demand for a cash payment in the amount of the excess Incentive-based Compensation Received (as defined in the Policy) by such Participant, by reducing either the Number of Performance Shares to Vest attributable to such Participant constituting Incentive-based Compensation or the amount of Performance Share Proceeds payable on the Vesting Date of such Performance Shares, or by any other method provided for in, or contemplated by, the Policy. In the case of any Performance Shares to vest for which the Overall Target Achievement is determined based on the

Page 9/19


achievement of both Performance Targets that are Financial Reporting Measures (as defined in the Policy) and Performance Targets that are not Financial Reporting Measures, the portion of such Performance Shares to vest recoverable by the Company shall be determined by the weighting criteria assigned to the respective Performance Targets.

(d)

In the event of any inconsistency between the terms of any grant under this Plan and the provisions of this Clause 7.5, this Clause 7.5 shall govern.

8.

Performance Shares in Special Cases

8.1

Retirement

(a)

For the purpose of this Plan, retirement is defined as a case in which the Participant has reached the age of 63 years and his/her employment or service relationship with FME Group ends (the Retirement). In case of Retirement, the Participant’s Performance Shares shall vest on the respective Vesting Date, subject to the fulfillment of the additional vesting condition pursuant to Clause 6.2(b).

(b)

Sentence 2 of the preceding Clause 8.1(a) shall apply accordingly if (i) the Mandatory Retirement Age applicable to the Participant is lower than 63 years, (ii) the Participant reaches this Mandatory Retirement Age and (iii) the Participant’s employment or service relationship with FME Group ends.

(c)

As far as legally permissible, all of those Participant’s Performance Shares which have not yet been settled and paid out according to Clause 7 above are forfeited with immediate effect if the Participant, within twelve months after his/her employment or service relationship with FME Group has ended, engages in activities that, in the reasonable judgment of the Company, are directly or indirectly competitive to FME Group, including entering into any employment or service relationship with any entity or person engaged in activities directly or indirectly competitive to FME Group; if the prerequisites for a forfeiture were present, but the Participant’s Performance Shares have already been settled and paid out, the consequences in Clause 11.4 shall apply to the relevant Performance Shares Proceeds.

8.2

Occupational Disability

In the event of the Participant’s Occupational Disability, Clause 8.1(a) sentence 2 shall apply mutatis mutandis if (i) the Participant provides the Company, or an institution designated by the Company, with suitable evidence of his/her Occupational Disability within three months of the occurrence of the Occupational Disability and (ii) the Participant’s employment or service relationship with FME Group is terminated due to the Occupational Disability.

Page 10/19


If such evidence is not provided within the time limit, the Management Board may declare those Performance Shares to be forfeited which have not yet been settled and paid out according to Clause 7 above.

8.3

Termination of Employment or Service Relationship for other reasons

If a Participant’s employment or service relationship with FME Group has ended for any reason other than those specified in Clauses 8.1, 8.2 and 8.4, all Performance Shares not vested on the date on which the employment or service relationship of the Participant with FME Group ends are forfeited.

8.4

Death

In case of death of a Participant, all Performance Shares granted to the Participant until his/her death shall be deemed to have vested as per the expiration of the date of death. For purposes of calculating the Number of Performance Shares to Vest in the meaning of Clause 5, an Overall Target Achievement of 100% applies. The Heirs of the Participant are entitled to receive the Performance Shares Proceeds that are based on the average Stock Exchange Price effectively established over a period of 30 (thirty) calendar days prior to the date of death if they give evidence of their entitlement to the Company or an office named by the Company within three months after the death of the Participant; otherwise, the Management Board may declare the Performance Shares to be forfeited. The Heirs’ entitlement shall become due immediately upon demonstration of the aforementioned evidence and, if due, shall in any case be paid out before 15 March of the calendar year following the due date.

8.5

Termination for Cause

Notwithstanding Clauses 8.1 (Retirement), 8.2 (Occupational Disability) and 8.4 (Death), all Performance Shares shall be forfeited if FME Group terminates the Participant’s employment or service relationship for cause, or if at the time of leaving, there were grounds which would have entitled FME Group to terminate the employment or service relationship for cause. Such cause or grounds are, in particular, construed to exist in case of a Compliance Violation as defined in Clause 6.2(b).

Page 11/19


8.6

Effect of Change in Status as Affiliated Company

If a Participant is employed by a company which ceases to be or does not qualify as an Affiliated Company, all Performance Shares granted to the Participant shall be forfeited.

8.7

Individual Cases

In individual cases, the Management Board may deviate from the provisions of this Clause 8, taking duly into account the Company’s interests.

9.

No Transferability / Forfeiture

Performance Shares granted under this Plan and Performance Shares inherited according to Clause 8.4 are not transferable. With the exception of inheritance, any transfer, assignment or disposal of Performance Shares, such as the granting of sub-participations therein, pledging, granting usufruct rights (Nießbrauch) or the formation of a trust, shall be void and invalid. The same applies to legal transactions which are economically equal to a transfer, assignment or disposal.

10.

Taxes, Contributions and other Expenses

Performance Share Proceeds are gross proceeds. To the extent permitted by law and subject to relevant internal tax equalization guidelines and/or provisions agreed with the Participant, all taxes and other duties in connection with the Performance Shares shall be borne exclusively by the Participant or his or her legal successors. Any legal obligation of the Company or an Affiliated Company to pay income tax and other taxes or contributions on behalf of the Participant shall remain unaffected. For this purpose, the Company or an Affiliated Company are entitled to withhold the necessary amounts of the Participants’ compensation until taxes and other contributions have been paid in full or to withhold such income tax and other taxes or contributions and pay such withheld amounts over to the relevant taxing authority or authorities in accordance with applicable payroll withholding requirements. Furthermore, the Company or Affiliated Companies are entitled to request payment from the Participant in the amount of the necessary sum which may have to be withheld with respect to the Plan. The Company or an Affiliated Company may make the cash payment to the Participant under the Plan conditional upon, inter alia, of proof of payment of taxes and/or other contributions or upon adequate security provided by the Participant. As an example in this context, reference is made to the provisions of Section 38 (4) of the German Income Tax Act. Participants are responsible for their own tax advice, especially with regard to participation in the Plan.

Page 12/19


The Company or the Affiliated Companies make no representations or warranties as to the existence of any tax liability or otherwise. The Participant will receive a certificate from the Company confirming the financial benefit received. If the Participant is not subject to German tax liability, the above provisions shall apply in accordance with the applicable foreign tax law and/or double taxation treaties.

11.

Procedure, Ending and Adjustment of the Plan

11.1

The Plan shall be interpreted, waived, adjusted or otherwise administered, and may be amended or modified, by the Management Board and all Performance Shares granted to Participants will be approved by the Management Board. Adjustments to the Plan may also be made with regard to Performance Shares which have already been granted; however, if the adjustments are not specifically provided for in this Plan, this may not affect the value of the Performance Shares or the Participant shall be fully compensated for any financial loss suffered. Notwithstanding the foregoing, the Number of Granted Performance Shares shall be proportionately adjusted to take into account any share split or other subdivision of the Company’s outstanding shares by reclassification or otherwise into a greater number of shares or any reverse shares split or other combination or consolidation, by reclassification or otherwise, of the Company’s outstanding shares into a lesser number of shares. Following any such adjustment, the Performance Shares Proceeds payable to any Participant on the Vesting Date shall be calculated with respect to such adjusted number of Performance Shares.

11.2

In case of Extraordinary Developments, the Management Board is entitled to cap the amount of the Grant Value and/or the Number of Granted Performance Shares and/or the Performance Shares Proceeds to be paid to the Participants under the Plan. Furthermore, the Management Board is entitled to determine in certain cases that any extraordinary commercial, tax and/or economic circumstances (including, for the avoidance of doubt, Extraordinary Developments) that may occur during any relevant Performance Period affecting the degree of the Overall Target Achievement in relation to individual grants shall in full or in part be disregarded for purposes of determining the Overall Target Achievement pursuant to this Plan in relation to such grants, based on its reasonable discretion and taking into account the long-term interests of the Company.

11.3

The Management Board is entitled to end the Plan with effect for all Participants at any time. In such case, the Performance Shares already granted to the Participants remain unaffected.

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11.4

If a Participant has engaged in a Compliance Violation according to Clause 6.2(b) that has occurred and/or has been determined conclusively only after the settlement of Performance Shares within the meaning of Clause 7 above, the Management Board is entitled within its reasonable discretion to claim back the Performance Shares Proceeds, in whole or in part, from the Participant in the Company’s name, provided that and insofar as the Performance Shares Proceeds have been paid to the Participant at a point in time that is within a period of three years prior to the day on which the Company makes the repayment claim in text form. For the avoidance of doubt, the Company’s rights pursuant to this Clause 11.4 shall not prejudice any other rights the Company may have against the Participant in relation to any Compliance Violation under or in connection with his/her employment or service relationship with FME Group.

11.5

In general, benefit payments remain subject to a substantial risk of forfeiture until they are paid under Clause 7.1, due to the Service Condition imposed under Clause 6.2(a). In such cases, there is no “deferred compensation” and the constraints imposed by Section 409A of the IRC do not apply. In the case of payments due to Retirement (Clause 8.1), Occupational Disability (Clause 8.2) and death (Clause 8.4), Plan benefits may constitute “deferred compensation”. In those cases, the Plan complies with Section 409A of the IRC by paying benefits on the fixed date and in the fixed form specified in Clauses 8.1 and 8.4, as applicable, thereby complying with Treasury Regulation Section 1.409A-3(a)(4).

The administration of any amounts payable hereunder that constitute “deferred compensation” within the meaning of Section 409A will comply with Section 409A, and this Plan shall be administered, interpreted and construed in a manner intended to avoid the imposition of additional taxes, penalties or interest under Section 409A. The Management Board may exercise its right to adjust the Plan pursuant to Clause 11.1 above in order to preserve the intended tax consequences of the Performance Shares, and avoid the imposition of any tax under Section 409A. Notwithstanding the foregoing, the Participant shall be solely responsible and liable for the satisfaction of all taxes, penalties and interest that may be imposed on or for the account of the Participant or his or her beneficiaries in connection with this Plan (including any taxes, penalties and interest under Section 409A), and the Company or any Affiliated Company shall have no obligation to indemnify or otherwise hold the Participant (or any beneficiary) harmless from any or all of such taxes, penalties or interest.

In the event that any settlement to the Participant is deemed to be an instalment payment of nonqualified deferred compensation under Section 409A, each individual instalment payment shall be deemed to be a separate “payment” within the meaning of Treasury Regulation Section 1.409A-2(b)(2)(iii).

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Other than by taking actions specifically permitted under this Plan, the Participant shall not have the right, directly or indirectly, to designate the taxable year during which a payment shall be made under this Plan.

12.

Liability Risks, Exchange Risks and Tax Risks

12.1

The liability of the Company, its legal representatives, employees and agents – with the exception of liability for injury to life, body or health – is excluded for simple negligence and consequential loss and loss of profit.

12.2

The Company grants no warranty for the general market development and price of the shares of the Company after granting Performance Shares or for any other point or period in time. Therefore, the acceptance of Performance Shares is at the sole risk of each Participant.

12.3

The Company grants no warranty that the tax and contributions deducted in accordance with Clause 10 (Taxes, Contributions and other Expenses) or other tax and contributions payable by the Participants will be charged only on the Performance Shares Proceeds. Depending on a Participant’s personal circumstances, double taxation might occur if the Plan is subject to taxation in several countries. The Participants are advised to obtain advice on their personal tax situation.

13.

Term of the Plan

This Plan will be effective as of 1 January 2024. It shall apply to grants of Performance Shares as of fiscal year 2024. The Plan will terminate following the payout of any Performance Shares Proceeds for the last grant made, or earlier, in the case the Management Board resolves so. Clauses 11.1 and 11.3 remain unaffected.

14.

Miscellaneous Provisions

14.1

This Plan is subject to German law excluding its provisions on the conflict of laws. The German text version of the Plan shall prevail in all cases.

14.2

No provisions contained in this Plan (or in any documents referring to this Plan) transfer to a Participant or possible Participant any right to request the continuation of his/her employment or service relationship with the Company or any Affiliated Company. No employment or service relationship can be deducted from this Plan (or from any documents referring to this Plan), nor shall it have any effect on the right of the Company or any Affiliated Company to change compensation or other benefits of

Page 15/19


such Participant or to terminate his/her employment or service relationship with or without notice. This applies with the proviso that no provision in this Plan or in any document connected therewith will adversely influence any independent contractual right of these persons.

14.3

If any provision of this Plan is invalid or unenforceable, the validity or enforceability of the remaining provisions of the Plan shall not be affected. The same applies if it is ascertained that the Plan is subject to an omission. In these cases, the invalid or unenforceable provision shall be substituted or an omission repaired by such provision which most closely corresponds to the intended purpose of this Plan.

14.4

References and headings attributed to individual Clauses and Sub-clauses of this Plan are solely for the purpose of easier reference. These headings are in no case significant or relevant for the interpretation of the Plan.

14.5

No provision in this Plan leads to or infers a presumption that the authority of the Management Board to issue Performance Shares or approve other compensation connected or not connected to shares granted by any other share based long-term incentive program or any other authority may in any way be restricted.

15.

Definitions

15.1

Affiliated Company means any company within FME Group with the exception of the Company.

15.2

Company stands for Fresenius Medical Care AG, a stock corporation incorporated under the laws of Germany.

15.3

Compliance Violation is defined in Clause 6.2(b).

15.4

Exhibits is defined in Clause 5.7.

15.5

Extraordinary Developments shall mean any kind of extraordinary scenarios in which the market price of the Company’s shares would have lost any reasonably arguable correlation to the Company’s intrinsic enterprise value (such as hyper-inflation); however, no such Extraordinary Development shall be applicable in cases in which the market price of Company’s shares rises (even substantially) as a result of the performance of the Participants.

15.6

Financial Reporting Measures has the meaning as defined in the Policy.

Page 16/19


15.7

FME Group stands for the group of entities including the Company and its affiliated companies within the meaning of Sections 15 et seqq. of the German Stock Corporation Act; for the avoidance of doubt, this does not include Fresenius SE & Co. KGaA and the companies affiliated with Fresenius SE & Co. KGaA within the meaning of Sections 15 et seqq. of the German Stock Corporation Act in any manner other than through the Company.

15.8

Foreign Currency Exchange Rates means the nominal prices of the foreign exchange rates as published by the European Central Bank. If no prices are published by the European Central Bank, the Management Board is entitled to agree on a suitable other form for obtaining the prices.

15.9

FX Rates at Grant Date is defined in Clause 4.2.

15.10

Grant Currency is defined in Clause 4.2.

15.11

Grant Date is defined in Clause 4.1.

15.12

Grant Value is defined in Clause 4.2.

15.13

Heir means the person, the persons, the trust or trusts, which are nominated by a Participant or, if no such nomination is made, is or are entitled by will or the respective applicable law in the event of the death of a Participant, to receive the benefit of the Performance Shares under this Plan. The concept “heir” therefore also includes the executor appointed by will or the administrator appointed by the court, if no heir is named and is in a position to act under the given circumstances.

15.14

IFRS means the “International Financial Reporting Standards” which are issued by the International Accounting Standards Board, as amended.

15.15

Incentive-based Compensation has the meaning as defined in the Policy.

15.16

IRC means the U.S. Internal Revenue Code of 1986, as amended from time to time.

15.17

Management Board is defined in Clause 1.1.

15.18

Mandatory Retirement Age is the age which, when reached or exceeded, causes the mandatory termination of the Participant’s employment or service relationship with the Company or the Affiliated Company as per the employment or service contract or as per the local laws and regulations applicable to the Participant’s employment or service relationship. A termination within the meaning of the preceding sentence shall not be caused (i) in circumstances where the termination of the employment or service

Page 17/19


relationship is the result of a unilateral declaration or a subsequent individual agreement between the Company or an Affiliated Company on the one hand and the Participant on the other hand at a time when the Participant has not yet reached the age defined in sentence 1 or (ii) as long as the Company or an Affiliated Company on the one hand and the Participant on the other hand agree subsequently to continue the employment or service relationship in excess of the age defined in sentence 1. In this respect, the local laws and regulations applicable to the Participant’s employment or service relationship are the laws and regulations of the local employment or service relationship, i.e., the laws and regulations of the country or state in which the Participant regularly performs his/her work in accordance with the rules governing his/her employment or service relationship or, in the absence of contractual provisions or other arrangements regarding the place of work, the laws and regulations of the country or state from which the Participant regularly carries out the predominant part of his/her work in fulfillment of the employment or service relationship; the country or state where the predominant part of the work is regularly carried out shall not be deemed to have changed if the Participant is temporarily employed in another country or state or is performing services in another country or state, e.g., during a global assignment within FME Group. In such cases, the employment or service relationship with the home employer is deemed to be the local employment or service relationship for the purposes of this Plan, even if it is temporarily suspended.

15.19

Number of Granted Performance Shares is defined in Clause 4.2.

15.20

Number of Performance Shares to Vest is defined in Clause 5.1.

15.21

Occupational Disability is a condition in which the Participant is unable, for an indefinite period of time, to exercise his/her current position or a comparable replacement position in an employment or service relationship with the FME Group under normal conditions, due to illness or disability. For the purposes of this Plan, a Participant’s classification as fully disabled by the US Social Security Administration constitutes Occupational Disability. If the Participant and/or the relevant employment or service relationship is subject to German law, only a reduction in earning capacity within the meaning of § 43 SGB VI is relevant.

15.22

Overall Target Achievement is defined in Clause 5.4.

15.23

Participant is defined in Clause 1.1.

15.24

Performance Period is defined in Clause 5.2.

15.25

Performance Shares is defined in Clause 1.1.

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15.26

Performance Shares Proceeds is defined in Clause 7.1.

15.27

Performance Targets is defined in Clause 5.1.

15.28

Plan is defined in Clause 1.1.

15.29

Plan Conditions is defined in Clause 1.2.

15.30

Policy is defined in Clause 7.5(a).

15.31

Retirement is defined in Clause 8.1(a).

15.32

Service Condition is defined in Clause 6.2(a).

15.33

Settlement Currency is defined in Clause 7.2.

15.34

Stock Exchange Price means the closing price (Schlusskurs) of the Company’s shares in the electronic XETRA trading system of Deutsche Börse AG in Frankfurt/Main or a comparable successor system denominated in Euro. If no closing price is set in the XETRA trading system, the Management Board is entitled to replace the closing price by suitable means.

15.35

Treasury Regulation means the income tax regulations, including temporary and proposed regulations, promulgated under the U.S. Internal Revenue Code by the United States Treasury, as such regulations may be amended from time to time (including corresponding provisions of succeeding regulations).

15.36

Vesting Date is defined in Clause 6.1.

Page 19/19


EX-31.1 3 fms-20240930xex31d1.htm EXHIBIT 31.1

Exhibit 31.1

CERTIFICATION PURSUANT TO SECTION 302

OF THE SARBANES-OXLEY ACT OF 2002

I, Helen Giza, certify that:

1.

I have reviewed this report on Form 6-K of Fresenius Medical Care AG;

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;

4.

The company’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:

a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c)

Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d)

Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and

5.

The company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):

a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and

b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.

Date: November 5, 2024

By: /s/ HELEN GIZA

Helen Giza

Chief Executive Officer and Chair of the Management Board


EX-31.2 4 fms-20240930xex31d2.htm EXHIBIT 31.2

Exhibit 31.2

CERTIFICATION PURSUANT TO SECTION 302

OF THE SARBANES-OXLEY ACT OF 2002

I, Martin Fischer, certify that:

1.

I have reviewed this report on Form 6-K of Fresenius Medical Care AG;

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;

4.

The company’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:

a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c)

Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d)

Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and

5.

The company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):

a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and

b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.

Date: November 5, 2024

By: /s/ MARTIN FISCHER

Martin Fischer

Chief Financial Officer and member of the Management Board


EX-32.1 5 fms-20240930xex32d1.htm EXHIBIT 32.1

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C.SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the report of Fresenius Medical Care AG (the Company) on Form 6-K furnished for the month of November 2024 containing its unaudited financial statements as of September 30, 2024 and for the three-month and nine-month periods ending September 30, 2024 and 2023, as submitted to the Securities and Exchange Commission on the date hereof (the Report), the undersigned, Helen Giza, Chief Executive Officer and Chair of the Management Board, certifies, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

(1)

The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

By:

/s/ HELEN GIZA

Helen Giza

Chief Executive Officer and Chair of the Management Board

November 5, 2024


EX-32.2 6 fms-20240930xex32d2.htm EXHIBIT 32.2

Exhibit 32.2

CERTIFICATION PURSUANT TO

18 U.S.C.SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the report of Fresenius Medical Care AG (the Company) on Form 6-K furnished for the month of November 2024 containing its unaudited financial statements as of September 30, 2024 and for the three-month and nine-month periods ending September 30, 2024 and 2023, as submitted to the Securities and Exchange Commission on the date hereof (the Report), the undersigned, Martin Fischer, Chief Financial Officer and member of the Management Board, certifies, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

(1)

The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

By:

/s/ MARTIN FISCHER

Martin Fischer

Chief Financial Officer and member of the Management Board

November 5, 2024