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    SEC Form 11-K filed by Fresenius Medical Care AG

    6/27/25 1:51:36 PM ET
    $FMS
    Misc Health and Biotechnology Services
    Health Care
    Get the next $FMS alert in real time by email
    11-K 1 tm2518880d1_11k.htm FORM 11-K

     

     

     

    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    WASHINGTON, D.C. 20549

     

    FORM 11-K

     

    ANNUAL REPORT PURSUANT TO

    SECTION 15(d) OF THE

    SECURITIES EXCHANGE ACT OF 1934

     

    (Mark One)

     

    xANNUAL REPORT PURSUANT TO SECTION 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

     

    For the fiscal year ended December 31, 2024

     

    OR

     

    ¨TRANSITION REPORT PURSUANT TO SECTION 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

     

    For the transition period from __________________ to __________________

     

    Commission file number       001-32749     

     

    A.Full title of the plan and the address of the plan, if different from that of the issuer named below:

     

    Fresenius Medical Care North America 401(k) Savings Plan

    920 Winter Street

    Waltham, MA 02451-1457

     

    B.Name of issuer of the securities held pursuant to the plan and the address of its principal executive office:

     

    Fresenius Medical Care AG

    Else-Kröner Straße 1

    61352 Bad Homburg, v.d. H. Germany

     

     

     

     

     

    fresenius medical care north america 401(k) savings plan

     

     

     

    FINANCIAL STATEMENTS AND SUPPLEMENTAL SCHEDULES

     

    December 31, 2024 and 2023 and

    For the Year Ended December 31, 2024

     

     

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN

     

    FINANCIAL STATEMENTS AND SUPPLEMENTAL SCHEDULES

    AND REPORT OF

    INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

     

    Fresenius Medical Care North America 401(k) Savings Plan (the "Plan") is subject to the Employer Retirement Income Security Act of 1974 ("ERISA").  Therefore, in lieu of the requirements of Items 1-3 of Form 11-K, the following financial statements and schedules have been prepared in accordance with the financial reporting requirements of ERISA.

     

    The following financial statements and schedules are filed as a part of this Annual Report on Form 11-K:

     

    INDEX
         
        Page
     
    REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM 1-2
         
    FINANCIAL STATEMENTS:  
         
      Statements of Net Assets Available for Benefits as of December 31, 2024 and 2023 3
         
      Statement of Changes in Net Assets Available for Benefits for the year ended December 31, 2024 4
         
      Notes to Financial Statements 5-18
         
    SUPPLEMENTAL SCHEDULES*:  
         
      Schedule of Assets (Held at End of Year) as of December 31, 2024 19
         
      Schedule of Delinquent Participant Contributions for the year ended December 31, 2024 20
         
    SIGNATURES:  
         
      Signatures 21
         
    CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
         
      Exhibit Index 22
         
      Exhibit 23.1 - Consent of WithumSmith+Brown, PC 23

     

    *- Other schedules required by Section 2520.103-10 of the Department of Labor Rules and Regulations for Reporting and Disclosure under ERISA have been omitted because they are not applicable.

     

     

     

     

    Report of Independent Registered Public Accounting Firm

     

    To Participants and the Administrative Committee of

    Fresenius Medical Care North America 401(k) Savings Plan:

     

    Opinion on the Financial Statements

     

    We have audited the accompanying statements of net assets available for benefits of the Fresenius Medical Care North America 401(k) Savings Plan (the “Plan”) as of December 31, 2024 and 2023, the related statement of changes in net assets available for benefits for the year ended December 31, 2024, and the related notes and schedules (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the net assets available for benefits of the Plan as of December 31, 2024 and 2023, and the changes in net assets available for benefits for the year ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.

     

    Basis for Opinion

     

    These financial statements are the responsibility of the Plan’s management. Our responsibility is to express an opinion on these financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Plan in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

     

    We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Plan is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purposes of expressing an opinion on the effectiveness of the Plan’s internal control over financial reporting. Accordingly, we express no such opinion.

     

    Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

     

     1 

     

     

    Supplemental Information

     

    The supplemental information in the accompanying Schedule H, Part IV, Line 4i - Schedule of Assets (Held at End of Year) as of December 31, 2024 and Schedule H, Part IV, Line 4a - Schedule of Delinquent Participant Contributions for the year ended December 31, 2024 has been subjected to audit procedures performed in conjunction with the audit of Fresenius Medical Care North America 401(k) Savings Plan’s financial statements. The supplemental information is the responsibility of the Plan’s management. Our audit procedures included determining whether the supplemental information reconciles to the financial statements or the underlying accounting and other records, as applicable, and performing procedures to test the completeness and accuracy of the information presented in the supplemental information. In forming our opinion on the supplemental information in the accompanying schedules, we evaluated whether the supplemental information, including its form and content, is presented in conformity with the Department of Labor’s Rules and Regulations for Reporting and Disclosure under the Employee Retirement Income Security Act of 1974. In our opinion, the supplemental information in the accompanying schedules is fairly stated, in all material respects, in relation to the financial statements as a whole.

     

    /s/ WithumSmith+Brown, PC

     

    We have served as the Fresenius Medical Care North America 401(k) Savings Plan’s auditor since 1999.

     

    Whippany, New Jersey

    June 27, 2025

     

     2 

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN

     

    STATEMENTS OF NET ASSETS AVAILABLE FOR BENEFITS

     

    DECEMBER 31, 2024 AND 2023

     

    ASSETS:  2024   2023 
    Investments, at fair value  $3,176,427,504   $2,796,774,900 
    Stable value investment at contract value   980,609,332    969,588,557 
    Contributions receivable - employer   81,075,294    77,539,988 
    Notes receivable from participants   132,219,515    124,546,030 
    Receivable for securities sold   328,115    105,021 
    Total assets   4,370,659,760    3,968,554,496 
               
    LIABILITIES:          
    Payable for securities purchased   993,663    843,377 
    Accrued administrative expenses   647,224    753,330 
    Total liabilities   1,640,887    1,596,707 
               
    NET ASSETS AVAILABLE FOR BENEFITS  $4,369,018,873   $3,966,957,789 

     

    See accompanying notes to financial statements.

     

     3 

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN

     

    STATEMENT OF CHANGES IN NET ASSETS AVAILABLE FOR BENEFITS

     

    YEAR ENDED DECEMBER 31, 2024

     

    ADDITIONS:    
         
    Participant contributions -     
    Salary deferrals  $273,027,902 
    Rollovers   29,046,322 
    Employer contributions -     
    Matching   80,711,968 
    Defined contribution   363,326 
    Interest income on notes receivable from participants   11,011,710 
    Dividend and interest income   43,699,611 
    Net appreciation in value of investments   436,594,451 
          
    Total additions   874,455,290 
          
    DEDUCTIONS:     
          
    Benefits paid to participants   469,774,533 
    Administrative expenses   2,619,673 
          
    Total deductions   472,394,206 
          
    NET ADDITIONS   402,061,084 
          
    NET ASSETS AVAILABLE FOR BENEFITS, BEGINNING OF YEAR   3,966,957,789 
          
    NET ASSETS AVAILABLE FOR BENEFITS, END OF YEAR  $4,369,018,873 

     

    See accompanying notes to financial statements.

     

     4 

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN

     

    NOTES TO FINANCIAL STATEMENTS

     

    1.            DESCRIPTION OF THE PLAN

     

    Organization - Fresenius Medical Care North America 401(k) Savings Plan (the “Plan”) is sponsored by National Medical Care, Inc. d/b/a Fresenius Medical Care North America (“NMC” and, together with certain entities owned or controlled by, or under common control with NMC, the “Company”) for the benefit of the employees of the Company. NMC is an indirect, wholly owned subsidiary of Fresenius Medical Care AG, a German stock corporation (“Fresenius Medical Care AG”), formerly called Fresenius Medical Care AG & Co. KGaA. The Company is a provider of renal dialysis products and services, and other healthcare products and services.

     

    The administration of the Plan is the responsibility of the Administrative Committee, which is appointed by NMC’s Board of Directors. Fidelity Management Trust Company (“Fidelity”) serves as the trustee and recordkeeper of the Plan.

     

    The following description of the Plan provides only general information. Special provisions may apply for certain participants who joined the Plan pursuant to Company acquisitions. Participants should refer to the Plan document for a complete description of the Plan’s provisions.

     

    General - The Plan is a defined contribution plan covering substantially all employees of the Company who have fulfilled the eligibility requirements outlined in the Plan’s provisions. The Plan is subject to the provisions of the Employee Retirement Income Security Act of 1974, as amended (“ERISA”). A summary description of the Plan is available from the Plan administrator.

     

    Eligibility - An employee becomes eligible for participation in the Plan on the first day of the month following the completion of ninety days of service, subject to further limitations, as described in the Plan document. Temporary employees become eligible to make elective contributions beginning the first of the month after completing one year of service. One year of eligible service is earned by completing at least 900 hours of service.

     

    Participant Accounts - Each participant’s account is credited or charged with contributions, investment income or loss, and administrative expenses. Investment income or loss, including realized and unrealized gains and losses, and expenses are allocated to participants’ accounts based on each participant’s account balance within each fund. Participants determine the percentage in which contributions are to be invested in each fund. Participants may change their investment options as set forth in the plan document. The benefit to which a participant is entitled is equal to the value of the Participant's vested interest in their account.

     

     5 

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN

     

    NOTES TO FINANCIAL STATEMENTS

     

    1.            DESCRIPTION OF THE PLAN (continued)

     

    Participant and Company Contributions - Each participant may contribute from 1% to 75% of his or her eligible earnings on a pre-tax basis or Roth basis, subject to Internal Revenue Code (“IRC”) limitations. Participating employees age 50 and above may elect to make “catch-up” contributions subject to IRC limitations. The maximum additional “Catch Up” contribution was $7,500 for 2024. Participants may also contribute funds from another qualified plan (“rollover contributions”), subject to certain requirements.

     

    The Company makes matching contributions to the Plan at an amount equal to 50% of the first 6% of eligible employee earnings, subject to certain limitations. Company matching contributions commence for participants who have completed ninety days of service as of the first day of the calendar month and must be an eligible employee on the last day of the Plan year. Company matching contributions are funded on an annual basis.

     

    Company Profit Sharing - The Company may make discretionary profit-sharing contributions to the Plan for the benefit of all eligible participants. Employees who have completed ninety days of service for the plan year for which the contribution relates and are employed by the Company on the last day of the plan year for which the contribution relates are eligible to participate in this component of the Plan. Any discretionary profit-sharing contributions are immediately 100% vested and are allocated to eligible participants based on compensation, with participants having ten years or more of service as of January 1, 2002, entitled to a higher profit-sharing allocation. There was no profit-sharing contribution made to the Plan in 2024.

     

    Forfeitures and Uncashed Account Checks - At December 31, 2024 and 2023, forfeited account balances and uncashed account checks totaled $5,697,165 and $5,497,822, respectively. Forfeitures are used to reduce Company contributions and/or offset administrative expenses in the Plan. In January 2025, the Company used $2,660,421 of the forfeiture account balance to reduce Company matching contributions for 2024 that were funded in 2025. In January 2024, the Company used $2,468,423 of the forfeiture account balance to reduce Company matching contributions in 2023 that were funded in 2024.

     

    Unallocated Assets - The Plan holds assets in a revenue credit account which receives deposits as a result of a revenue sharing agreement with Fidelity Management Trust Company. For the year ended December 31, 2024, deposits to the account totaled $2,657,628, which is included in net appreciation in value of investments on the statement of changes in net assets available for benefits. Funds in the account are used to pay ERISA-qualified expenses and/or allocated to participant accounts. For the year ended December 31, 2024, $2,928,978 was used to pay plan expenses. Unallocated assets were $4,167,887 and $4,305,925 at December 31, 2024 and 2023, respectively.

     

     6 

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN

     

    NOTES TO FINANCIAL STATEMENTS

     

    1.            DESCRIPTION OF THE PLAN (continued)

     

    Defined Contribution - The Company may elect to make payments to the Plan referred to as a “defined contribution” for the benefit of all eligible participants. Employees satisfying all of the following requirements are eligible to participate in this component of the Plan: (i) the employee was employed by the Company as of March 9, 2002; (ii) the employee was a participant in the Fresenius Medical Care North America Retirement Plan (“Pension Plan”) on March 9, 2002, and (iii) the employee had completed ten years of benefit service as of March 9, 2002. Employees eligible to participate will receive a defined contribution allocation for a given plan year only after the completion of 15 years of benefit service as long as the employee is employed by the Company on the last day of the plan year for which the contribution relates. Eligible participants are immediately 100% vested in such contributions. The amount of the defined contribution for each eligible participant is actuarially determined and is principally based on the participant’s length of service, level of compensation, projected benefit from the Pension Plan, and the projected benefit from the profit-sharing component of this Plan. Certain actuarial assumptions related to annual compensation percentage increases, annual investment returns and anticipated profit-sharing funding levels are made in determining the defined contribution funding amounts. The amount of the defined contribution for the year ended December 31, 2024, is presented on the accompanying statement of changes in net assets available for benefits.

     

    Vesting - Participants are fully vested in that portion of their account which represents their contributions and the income earned thereon, Company profit sharing contributions, and defined contributions. Participants become 100% vested in the Company’s contributions and earnings thereon upon death, total and permanent disability, or attainment of normal retirement age. Participants terminated prior to January 1, 2007 vest in the employer matching contributions according to the vesting schedule in effect at the time of termination. Otherwise, a participant’s interest in the Company’s matching contributions and earnings thereon vests according to the following schedule:

     

    Period of Service Percentage Vested
    Less than 1 year              0%
    1 but less than 2 years            20%
    2 but less than 3 years            40%
    3 but less than 4 years            60%
    4 but less than 5 years            80%
    5 years or more          100%

     

     7 

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN

     

    NOTES TO FINANCIAL STATEMENTS

     

    1.            DESCRIPTION OF THE PLAN (continued)

     

    Distributions - At termination of employment or the date of disability, the participant is entitled to withdraw his or her vested account balance from the Plan. Any remaining unpaid loan balances at termination of employment are treated as distributions. Terminated employees with account balances of less than $5,000 must withdraw their account balances from the Plan. Terminated employees with participant account balances greater than $5,000 may elect to defer receiving distributions from the Plan until age 73. In certain instances, prior to termination, participants who suffer hardship may (subject to approval by the Administrative Committee and in compliance with ERISA) request a withdrawal from their account balance. In addition, plan participants are eligible to take in service distributions upon attainment of age 59 ½. In the event of a participant's death, the participant's vested account balance shall be distributed as soon as practicable thereafter to his or her beneficiary.

     

    Plan Termination - Although the Plan was established with the intention that it will continue indefinitely, the Company retains the right to discontinue its contributions at any time or to terminate the Plan, subject to the provisions of ERISA. In the event of plan termination, all participants will become 100% vested in their accounts.

     

    2.            SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

     

    Method of Accounting - The accompanying financial statements have been prepared using the accrual method of accounting under accounting principles generally accepted in the United States of America (“U.S. GAAP”).

     

    Investments - Investments are reported at fair value (except for fully benefit-responsive contracts which are reported at contract value). Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants on the measurement date. See Note 5 for discussion of fair value measurements.

     

    As required under U.S. GAAP, the Plan’s investment in a stable value separate account with underlying investments in a fully benefit-responsive investment contract is presented in the statements of net assets available for benefits at contract value. The statement of changes in net assets available for benefits with respect to such contract is also presented on a contract value basis. Contract value represents contributions made, plus earnings, less participant withdrawals and is the relative measurement attributable to a fully benefit-responsive investment contract because contract value is the amount participants would ordinarily receive if they were to initiate permitted transactions under the terms of the Plan.

     

     8 

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN

     

    NOTES TO FINANCIAL STATEMENTS

     

    2.            SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)

     

    Purchases and sales of securities are recorded on a trade-date basis. Interest income is recorded on the accrual basis. Dividends are recorded on the ex-dividend date. Net appreciation (depreciation) includes the Plan’s gains and losses on investments bought and sold as well as held during the year.

     

    Notes Receivable from Participants - Notes receivable from participants are measured at their unpaid principal balance plus any accrued but unpaid interest. Participants may borrow from their vested accounts a minimum of $500 up to a maximum equal to the lesser of $50,000 or 50 percent of their account balance. The loans are secured by the balance in the participant’s account. Loans must bear a reasonable rate of interest. All loans must be repaid within five years unless the proceeds are used to acquire a principal residence, in which case a longer repayment period is allowed. No more than two loans may be outstanding at any time. No allowance for credit losses has been recorded as of December 31, 2024 and December 31, 2023. Delinquent participant loans are reclassified as distributions based upon the terms of the Plan document.

     

    Payment of Benefits - Benefits are recorded when paid.

     

    Administrative Expenses - Certain administrative costs of the Plan are paid by the Company. In addition, certain investment-related administrative expenses are reflected as a reduction in net appreciation (depreciation) in value of investments and are not readily determinable.

     

    Estimates - The preparation of financial statements in conformity with U.S. GAAP requires the Plan administrator to make estimates and assumptions that affect certain reported amounts and disclosure of contingent assets and liabilities. Actual results may differ from those estimates.

     

     9 

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN

     

    NOTES TO FINANCIAL STATEMENTS

     

    3.            PARTICIPANT INVESTMENT OPTIONS

     

    The following table presents a description of the investment options and the fair value (or contract value as appropriate – see Notes 4 and 5) of the investments of each fund option as of December 31:

     

       2024   2023 
    BlackRock Large Cap Blend Index Fund Option - This option invests in the Equity Index Fund F, a collective investment fund offered by BlackRock Institutional Trust Company N.A., that seeks to match the performance of the S&P 500® Index by investing in stocks that make up the index.  $891,265,424   $755,422,355 
               
    BlackRock Mid Cap Index Fund Option - This option invests in the Mid Capitalization Equity Index Fund F, a collective investment fund offered by BlackRock Institutional Trust Company N.A., that seeks to match the performance of the S&P 400® Index by investing in stocks that make up the index.   162,418,850    156,512,720 
               
    BlackRock Small Cap Index Fund Option - This option invests in the Russell 2000® Index Fund F, a collective investment fund offered by BlackRock Institutional Trust Company N.A., that seeks to match the performance of the Russell 2000® Index by investing in a diversified sample of stocks that make up the index.   143,956,335    141,091,942 
               
    BlackRock International Index Fund Option - This option invests in the BlackRock MSCI ACWI EX – U.S. Index Fund F, a collective investment fund offered by BlackRock Institutional Trust Company N.A., that seeks to match the performance of the MSCI ACWI EX – U.S. Index by investing in stocks that make up the index.   79,648,194    79,584,431 
               
    BlackRock U.S. Debt Index Fund Option - This option invests in the U.S. Debt Index Fund F, a collective investment fund offered by BlackRock Institutional Trust Company N.A., that seeks to match the performance of the Barclays Capital Aggregate Bond Index by investing in a diversified sample of the bonds that make up the index.   49,217,923    51,386,619 
               
    BlackRock TIPS Index Fund Option - This option invests in the U.S. Treasury Inflation Protected Securities Fund F, a collective investment fund offered by BlackRock Institutional Trust Company N.A., that seeks to match the performance of the Barclays Capital U.S. TIPS Index by investing in some or all of the bonds that make up the index.   15,186,747    17,214,504 
               
    BlackRock Emerging Markets Index Fund Option - This fund invests in the Emerging Markets Index Non-Lendable Fund F, a collective investment fund offered by BlackRock Institutional Trust Company N.A., that seeks to match the performance of the MSCI Emerging Markets Index by investing in stocks that make up the index.   24,974,974    23,704,285 
               
     MassMutual Stable Value Separate Account Option - This option is designed to provide a stable rate of return, generated from performance of a Core Bond portfolio, that insulates the fund from daily fluctuations in the bond market. The fixed rate of return resets quarterly.                 454,069,974    481,663,282 

     

     10 

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN

     

    NOTES TO FINANCIAL STATEMENTS

     

    3.            PARTICIPANT INVESTMENT OPTIONS (continued)

     

    Target Date Retirement Funds Option - These options invest in a mix of the above underlying funds and are designed for Plan participants expecting to retire around the year indicated in the fund name. The asset allocation strategy of these options generally become increasingly conservative as the target retirement date approaches. The target date options are as follows:          
               
    Target Retirement Income Fund Option   138,537,167    157,058,953 
    Target Retirement 2025 Fund Option   254,631,759    266,141,849 
    Target Retirement 2030 Fund Option   381,440,477    338,112,100 
    Target Retirement 2035 Fund Option   429,670,822    363,732,055 
    Target Retirement 2040 Fund Option   338,769,467    285,786,375 
    Target Retirement 2045 Fund Option   255,958,769    213,917,305 
    Target Retirement 2050 Fund Option   321,824,757    268,602,451 
    Target Retirement 2055 Fund Option   37,802,277    22,202,574 
    Target Retirement 2060 Fund Option   23,901,505    13,306,938 
    Target Retirement 2065 Fund Option   11,879,203    6,455,738 
               
    Vanguard Long Term Bond Index Fund Option - This option is a publicly traded mutual fund that seeks to match the performance of the Barclays Capital U.S. Long Government/Credit Float Adjusted Bond Index.     30,397,222    33,912,197 
               
    Fresenius Company Stock Fund Option - This option invests in Fresenius Medical Care AG company stock. This option was frozen as of June 15, 2015, except for reinvestment of dividends on such stock.   15,861,109    16,910,127 
               
    Self-Directed Brokerage Accounts - This investment option allows participants to establish a plan level brokerage account with Fidelity for the opportunity to invest in common stocks, mutual funds, corporate bonds and other investments.   78,318,569    59,295,880 
               
    Interest-Bearing Cash - This option automatically sweeps  uninvested cash into a deposit account where it earns interest.   17,305,302    14,348,777 
               
    Total  $4,157,036,836   $3,766,363,457 

     

     11 

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN

     

    NOTES TO FINANCIAL STATEMENTS

     

    4. STABLE VALUE SEPARATE ACCOUNT

     

    The Plan provides a stable value separate account option to participants, referred to as the “MassMutual Stable Value Separate Account” or Separate Account Guaranteed Investment Contract (“SAGIC”), consisting of an investment in an underlying guaranteed investment contract. This investment option is designed to provide a guaranteed rate of return with crediting interest rates that reset on a quarterly basis. The crediting interest rates were 3.70% and 3.79% at December 31, 2024 and 2023, respectively. The Plan has entered into a group annuity contract with Massachusetts Mutual Life Insurance Company (“MassMutual”), whereby deposits made by the Plan to the contract are maintained in an account separate from MassMutual’s general investment account thereby insulating the account from liability arising out of other business activities conducted by MassMutual. The separate account invests in a diversified portfolio of fixed income securities, including corporate, mortgage backed, and government and agency bonds and may include derivative instruments. At December 31, 2024, the contract value of the Plan’s investment in the contract was $980,609,332. At December 31, 2023, the contract value of the Plan’s investment in the contract was $969,588,557.

     

    The stable value separate account is considered fully benefit-responsive whereby participants are permitted to make withdrawals at contract value for benefit payments, loans or transfers to other investment options.

     

    If one of the following conditions was present it would limit the Plan’s ability to conduct transactions at contract value.

     

    1)Complete or partial termination of the Plan as notified by the Contractholder/Plan sponsor,

    2)Complete or partial termination of the SAGIC, as notified by the Contractholder/Plan sponsor,

    3)Determination by IRS that the Plan no longer meets Code Section 401(a),

    4)Breach of the SAGIC Contract by the Contractholder with inability to cure within 15 business days of breach.

    5)Market Value Event withdrawals, including but not limited to:

     

    ·Plan’s establishment, activation or material change to a Plan investment fund; change in regulation that will have a material adverse financial effect on MassMutual in the context of the SAGIC Agreement,

     

    ·Removal or transfer of a group of employees from the Plan due to layoff, merger, early retirement package, sale or discontinuance of all or any part of the Plan sponsor’s or Affiliated Employer’s business, etc.

     

    ·Employer directed transfer of assets from the SAGIC to any other fund.

     

    None of the above conditions were present as of December 31, 2024.

     

     12 

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN

     

    NOTES TO FINANCIAL STATEMENTS

     

    4.            STABLE VALUE SEPARATE ACCOUNT (continued)

     

    The Plan administrator does not believe that any events that would limit the Plan’s ability to transact at contract value with the Plan participants are probable of occurring.

     

    5.            FAIR VALUE MEASUREMENTS

     

    Under U.S. GAAP, fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. A fair value hierarchy has been established under U.S. GAAP that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements).

     

    The three levels of the fair value hierarchy are as follows:

     

    Level 1 Observable inputs based on unadjusted quoted prices for identical assets or liabilities in active markets that the Plan has the ability to access.
       
    Level 2 Inputs for assets or liabilities, other than quoted prices included in Level 1, which are either directly or indirectly observable as of the measurement date. Inputs include quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in inactive markets; and inputs derived principally from or corroborated by observable market data by correlation or other means.
       
    Level 3 Unobservable inputs where there is little or no market activity for the assets or liabilities. These inputs reflect Plan management’s assumptions of the data market participants would use in pricing an asset or liability, based on the best information available in the circumstances.

     

     13 

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN

     

    NOTES TO FINANCIAL STATEMENTS

     

    5.            FAIR VALUE MEASUREMENTS (continued)

     

    Following is a description of the valuation methodologies used for Plan assets measured at fair value at December 31, 2024 and 2023.

     

    Fresenius Medical Care AG shares - The Plan’s investment in American Depositary Receipts (ADRs) representing shares of Fresenius Medical Care AG (the parent company of the Plan sponsor), which trade on the New York Stock Exchange, is valued at the ADR’s closing price on the last business day of the Plan year.

     

    Mutual Funds - Shares of mutual funds are valued at quoted market prices, which represent the net asset value (NAV) of the shares held by the Plan at year end.

     

    Self-Directed Brokerage Accounts - Included in the self-directed brokerage accounts account are primarily common stocks, mutual funds, and corporate bonds. Common stocks are valued at end of year using quoted prices on the market on which the individual securities are traded. Certain corporate bonds are valued at the closing price on the market on which the bonds are traded. Corporate bonds traded in the over-the-counter market are valued at the average of the last reported bid and asked prices.

     

    Interest-bearing Cash – This investment is valued at historical cost, which approximates fair value.

     

    The methods described above may produce a fair value calculation that may not be indicative of net realizable value or reflective of future fair values. Furthermore, although the Plan believes its valuation methods are appropriate and consistent with other market participants, the use of different methodologies or assumptions to determine the fair value of certain financial instruments could result in a different fair value measurement at the reporting date.

     

     14 

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN

     

    NOTES TO FINANCIAL STATEMENTS

     

    5.            FAIR VALUE MEASUREMENTS (continued)

     

    The following tables set forth by level, within the fair value hierarchy, the Plan’s investments at fair value as of December 31, 2024 and 2023:

     

       December 31, 2024     
        Level 1    Level 2    Level 3    Total 
    Mutual Fund  $30,397,222   $-   $-   $30,397,222 
    Fresenius Medical                    
    Care AG - Shares   15,861,109    -    -    15,861,109 
    Self-Directed Brokerage Accounts (a)   77,290,279    1,132,428    -    78,422,707 
    Interest-Bearing Cash   17,201,163    -    -    17,201,163 
    Total Investments at Fair value  $140,749,773   $1,132,428   $-    141,882,201 
    Total Investments at Net Asset Value*                  3,034,545,303 
    Total Investments                 $3,176,427,504 

     

       December 31, 2023     
        Level 1    Level 2    Level 3    Total 
    Mutual Fund  $33,912,197   $-   $-   $33,912,197 
    Fresenius Medical                    
    Care AG & Co KGaA- Shares   16,910,127    -    -    16,910,127 
    Self-Directed Brokerage Accounts (a)   58,297,896    997,984    -    59,295,880 
    Interest-Bearing Cash   14,348,777    -    -    14,348,777 
    Total Investments at Fair value  $123,468,997   $997,984   $-    124,466,981 
    Total Investments at Net Asset Value*                  2,672,307,919 
    Total Investments                 $2,796,774,900 

     

    * In accordance with subtopic 820-10, certain investments that are measured at fair value using the NAV per share (or its equivalent) practical expedient have not been categorized in the fair value hierarchy. The fair value amounts presented in this table are intended to permit reconciliation of the fair value hierarchy to the amounts presented in the statements of net assets available for benefits.

     

    (a) - Investments in brokerage accounts of Plan participants choosing the “Self-Directed Brokerage Accounts” investment option. Such investments consist of a variety of classes of common stocks, mutual funds, corporate bonds and other investments as directed by Plan participants.

     

    For the year ended December 31, 2024, there were no transfers among Levels 1, 2 or 3.

     

     15 

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN

     

    NOTES TO FINANCIAL STATEMENTS

     

    The following table for December 31, 2024 and 2023 sets forth a summary of the Plan’s investments with a reported NAV.

     

                 Other  Redemption
       Fair Value   Fair Value   Redemption  Redemption  Notice
    Investments  December 31, 2024*   December 31, 2023*   Frequency  Restrictions  Period
    Equity Index Fund  $1,550,604,658   $1,302,698,374   Daily  None  None
                        
    Russell 2000 Index Fund   290,846,641    264,415,254   Daily  None  None
                        
    Mid Capitalization Equity Index Fund   344,787,918    310,992,951   Daily  None  None
                        
    U.S. Debt Index Fund   253,874,802    245,207,884   Daily  None   None
                        
    Blackrock MSCI ACWI EX U.S. Index Fund   441,356,082    403,492,159   Daily  None  None
                        
    U.S. Treasury Inflation Protection Securities Fund   30,746,298    34,689,646   Daily  None  None
                        
    Emerging Markets Index Non-Lendable Fund   122,328,904    110,811,651   Daily  None  None
                        
    Total  $3,034,545,303   $2,672,307,919          

     

    * The fair value of the investments has been estimated using the net asset value of the investment as a practical expedient.

     

    6.            NOTES RECEIVABLE FROM PARTICIPANTS

     

    Participants may at any time borrow up to 50% (but not more than $50,000) of their vested account balances with a minimum loan amount of $500. Such loans are secured by the participants’ account balances. The loans bear a reasonable rate of interest ranging from 4.25% to 10.75% per annum as of December 31, 2024, and 2023, and generally must be repaid in equal payments in five years or less. A longer repayment period may be allowed for loans granted to purchase a primary residence. In addition, participants borrow from their vested account balance. Plan participants are a party in interest and these transactions are exempt from the prohibited transaction rules.

     

     16 

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN

     

    NOTES TO FINANCIAL STATEMENTS

     

    7.            RELATED PARTY TRANSACTIONS AND PARTY IN INTEREST TRANSACTIONS

     

    The Plan invests in collective investment funds offered and managed by BlackRock Institutional Trust Company N.A. (“BlackRock”). Blackrock is a custodian of certain of the Plan’s investments and, therefore, these transactions qualify as party in interest transactions. Blackrock charged the Plan investment management fees of $586,934 for the year ended December 31, 2024. As of December 31, 2023, $147,499 was payable to Blackrock.

     

    Fidelity charged the plan recordkeeping fees of $1,192,775 for the year ended December 31, 2024, of which $604,723 and $147,499 was payable as of December 31, 2024 and 2023, respectively, and is included in accrued administrative expenses on the accompanying statements of net assets available for benefits. As of December 31, 2023, $3,038 was payable to Principal Trust Company for plan recordkeeping services.

     

    The Plan holds ADRs representing shares of Fresenius Medical Care AG, the parent company of the Plan sponsor. Transactions in such investments are considered party-in-interest transactions as defined by ERISA but are exempt from the prohibited transaction rules.

     

    8.            TAX STATUS OF THE PLAN

     

    The Internal Revenue Service, by letter dated April 30, 2015, determined that the Plan constitutes a qualified trust under Section 401(a) of the Internal Revenue Code (the "Code") and is, therefore, considered to be exempt from Federal income taxes under the provisions of Section 501(a). The Plan has been amended since receiving the determination letter; however, the Plan administrator and the Plan's tax counsel believe that the Plan is designed and is currently being operated in compliance with the applicable requirements of the Code. Accordingly, no provision for income taxes has been included in the Plan’s financial statements.

     

    U.S. GAAP requires Plan management to evaluate tax positions taken by the Plan and recognize a tax liability if the Plan has taken an uncertain position that more likely than not would not be sustained upon examination by the tax authorities. The Plan administrator has analyzed the tax positions taken by the Plan, and has concluded that as of December 31, 2024 and 2023, there are no uncertain tax positions taken or expected to be taken that would require recognition of a liability or disclosure in the financial statements. The Plan is subject to routine audits by the tax authorities; however, there are currently no audits for any tax periods in progress. In addition, there are no tax related interest or penalties for the periods presented in these financial statements.

     

     17 

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN

     

    NOTES TO FINANCIAL STATEMENTS

     

    9.            RISKS AND UNCERTAINTIES

     

    The Plan provides for various investment options in any combination of collective investment funds, stable value separate account, mutual funds and shares of Fresenius Medical Care AG (see Note 3), the parent company of the Plan sponsor. Additionally, Plan participants can invest in a wide array of securities through a plan level self-directed brokerage account. Such investments are exposed to various risks, such as interest rate, market, and credit risks. Due to such risks, it is at least reasonably possible that changes in market values, interest rates or other factors in the near term would materially affect participants’ account balances and the amounts reported in the statements of net assets available for benefits.

     

    10.          DELINQUENT PARTICIPANT CONTRIBUTIONS

     

    The Company remitted certain 2024 participant contributions and loan repayments of $29,124 to Fidelity later than as required by Department of Labor (DOL) Regulation 2510.3-102. The contributions and loan repayments, along with calculated lost earnings, were remitted to the affected participants' accounts during 2025.

     

    11.          SUBSEQUENT EVENTS

     

    The Company and the Plan have performed an evaluation of subsequent events through June 27, 2025 and determined that no significant subsequent events have occurred requiring adjustments to the financial statements or disclosures.

     

     18 

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN
     
    I.D. NO. - 04-2835488
     
    PLAN NO. - 002
     
    FORM 5500, SCHEDULE H, PART IV, LINE 4i -
    SCHEDULE OF ASSETS
    (HELD AT END OF YEAR)
     
    DECEMBER 31, 2024

     

    (a) (b)  (c)    (d)    (e) 
      Identity of Issuer  Description    Cost    Current Value 
      Collective Investment Funds -                   
                          
    * BlackRock Institutional Trust Company N.A.:                   
      Equity Index Fund F   12,503,150   Units    **    $1,550,604,658 
      Russell 200 Index Fund F   3,897,202   Units    **     290,846,641 
      Mid Capitalization Equity Index Fund F   2,120,352   Units    **     344,787,918 
      US Debt Index Fund F   7,594,652   Units    **     253,874,802 
      MSCI ACWI ex - U.S. Index Fund F   12,575,107   Units    **     441,356,082 
      U.S. Treasury Inflation Protected Securities Fund F   1,259,329   Units    **     30,746,298 
      Emerging Markets Index Non-Lendable Fund F   9,090,490   Units    **     122,328,904 
                        3,034,545,303 
                          
    * Fresenius Medical Care AG & Co. KGaA   700,579   Shares (ADRs)    **     15,861,109 
                          
      Mutual Fund -                   
      Vanguard Long-Term Bond Index Fund   444,209   Shares    **     30,397,222 
                          
      Interest-Bearing Cash   17,201,163   Units          17,201,163 
                          
      MassMutual Stable Value Separate Account   Group annuity contract     **     980,609,332 
                          
      Brokerage Link   Brokerage accounts     **     78,422,707 
                          
    * Notes Receivable from Participants   Interest range of 4.25 - 10.75%     -     132,219,515 
                          
      Total                $4,289,256,351 

     

    * - denotes a party-in-interest as defined by ERISA
    ** - participant directed
         
    SEE INDEPENDENT AUDITOR'S REPORT

     

     19 

     

     

    FRESENIUS MEDICAL CARE NORTH AMERICA 401(k) SAVINGS PLAN

     

    I.D. NO. - 04-2835488

     

    PLAN NO. - 002

     

    FORM 5500, SCHEDULE H, PART IV, LINE 4a -

    SCHEDULE OF DELINQUENT PARTICIPANT CONTRIBUTIONS

     

    For the Year Ended December 31, 2024

     

            Total that Constitute Nonexempt Prohibited Transactions     
    Plan Year  Participant
    Contributions
    Transferred
    Late to Plan
       Contributions Not
    Corrected
       Contributions
    Corrected Outside
    VFCP
       Contributions
    Pending Correction
    in VFCP
       Total Fully
    Corrected Under
    VFCP and PTE
    2002-51
     
    2024  $ 29,124 *  $29,124   $-   $-   $- 

     

    * Indicates late participant loan repayments are included

     

     20 

     

     

    SIGNATURES

     

    The Plan. Pursuant to the requirements of the Securities Exchange Act of 1934, the trustees (or other persons who administer the employee benefit plan) have duly caused this annual report to be signed on its behalf by the undersigned hereunto duly authorized.

     

        Fresenius Medical Care North America 401(k) Savings Plan
         
    Date June 27, 2025   By: /s/ Katie Knowlton
          Katie Knowlton
          Member of the Administrative Committee

     

     21 

     

     

    EXHIBIT INDEX

     

    Exhibit No.   Description of Exhibit Internal Page No.   Sequential Page No.  
    23.1   Consent of WithumSmith+Brown, PC   23   26

     

     22 

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    • SEC Form SC 13D/A filed by Fresenius Medical Care AG (Amendment)

      SC 13D/A - Fresenius Medical Care AG (0001333141) (Subject)

      12/7/23 11:45:52 AM ET
      $FMS
      Misc Health and Biotechnology Services
      Health Care