SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13A-16 OR 15D-16 UNDER THE
SECURITIES EXCHANGE ACT OF 1934
For the month of October 2022
Commission file number: 001-32749
(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 ☐ |
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
Interim Report of Financial Condition and Results of Operations for the three and nine months ended September 30, 2022 and 2021
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FRESENIUS MEDICAL CARE AG & Co. KGaA
FINANCIAL INFORMATION
Management’s discussion and analysis
In this report, “FMC AG & Co. KGaA,” or the “Company,” “we,” “us” or “our” refers to Fresenius Medical Care AG & Co. KGaA or Fresenius Medical Care AG & Co. KGaA 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, 2021 prepared in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board ("IASB”), using the euro as our reporting currency, included in our Annual Report on Form 20-F for the year ended December 31, 2021 (our "2021 Form 20-F").
The term “North America Segment” refers to our North America operating segment, the term “EMEA Segment” refers to the Europe, Middle East and Africa operating segment, the term “Asia-Pacific Segment” refers to our Asia-Pacific operating segment, and the term “Latin America Segment” refers to our Latin America operating segment. The term "Corporate" includes certain headquarters’ overhead charges, including accounting and finance, centrally managed production, production asset management, quality and supply chain management, procurement related to production as well as research and development and our Global Medical Office function, which seek to optimize medical treatments and clinical processes within the Company. 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 FMC AG & Co. KGaA 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.”
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” and similar expressions are generally intended to identify forward looking statements. Although we believe that the 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 even be anticipated, and future events and actual results, financial and otherwise, 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 commercial insurer 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 or repeal the ACA, and changes by regulators to certain reimbursement models, such as the End-Stage Renal Disease (“ESRD”) Treatment Choices model and the Comprehensive Kidney Care Contracting 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, rules regarding the use of government relief funding received in connection with the on-going worldwide severe acute respiratory syndrome coronavirus 2 and the related Coronavirus disease (“COVID-19”) pandemic, other government regulation including, in the U.S., the Anti-Kickback Statute, the False Claims Act, 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”) including our non-prosecution agreement with the U.S. |
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Department of Justice (“DOJ”) and the cease and desist order of the U.S. Securities and Exchange Commission (“SEC”), as well as the Food, Drug and Cosmetic Act and, outside the U.S., inter alia, the European Union (“EU”) Medical Device Regulation, the EU General Data Protection Regulation, 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; |
● | the influence of commercial insurers and integrated care organizations, including efforts by these organizations to manage costs by limiting health care benefits, narrowing their networks, reducing provider reimbursement and/or restricting options for patient funding of health insurance premiums, including potential efforts by commercial insurers to make dialysis reimbursement payments at a lower “out-of-network” rate as a result of the U.S. Supreme Court’s ruling in Marietta Memorial Hospital Employee Health Benefit Plan v. DaVita Inc., No. 20-1641 (Oct. Term 2021), decided June 21, 2022; |
● | the impact of the 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, both of which may be attributable to COVID-19, as well as the impacts of the virus on our patients, caregivers, employees, suppliers, supply chain, business and operations, the uncertainties arising from the development of variants of COVID-19, consequences of an economic downturn resulting from the impacts of COVID-19 and evolving guidelines and requirements regarding vaccine mandates for our employees and the use of government provided COVID-19 related relief and any additional economic relief legislation that may be passed in the countries in which we operate; |
● | our ability to attract and retain skilled employees and personnel shortages which have increased in light of the COVID-19 pandemic and vaccine mandates for certain workers, and risks that personnel shortages and competition for labor, 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 in operations and 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 on our cost savings initiatives and increases due to geopolitical conflicts in certain regions (for example, impacts related to the war in 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 government and internal investigations as well as litigation; |
● | product liability risks and the risk of regulator recalls of our products; |
● | our ability to continue to grow our health care services and products businesses, including through acquisitions, and to implement our strategy targeting the entire renal care continuum, complementary assets and critical care solutions; |
● | the impact of currency and interest rate fluctuations, including the heightened risk of fluctuations as a result of geopolitical conflicts in certain regions (for example, impacts related to the Ukraine War), the impact of the current macroeconomic inflationary environment on interest rates and a related effect on our borrowing costs; |
● | 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 (for example, the Ukraine War); |
● | our ability to protect our information technology systems and protected health information against cyber security attacks or prevent other data privacy or security breaches of our data or the data of our third parties 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; |
● | introduction of generic or new pharmaceuticals and medical devices that compete with our products or services or the development of pharmaceuticals that reduce the progression of chronic kidney disease; |
● | launch of new technology, advances in medical therapies, or new market entrants that compete with our businesses; |
● | 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 (for example, the Ukraine War); |
● | collectability of our receivables, which depends primarily on the efficacy of our billing practices, the financial stability and liquidity of our governmental and commercial payors and payor strategies to delay or thwart the collection process; |
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● | our ability to secure contracts and achieve cost savings and desired clinical outcomes in various 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; and |
● | our ability to implement the transformation of our company structure and to achieve projected cost savings within the proposed timeframe as part of the previously announced FME25 Program, as defined in “Financial condition and results of operations – I. Overview - Company Structure,” below. |
Important factors that could contribute to such differences are noted in “Supplemental information regarding our risk factors” and “Financial condition and results of operations – I. Overview” below, in note 3 d) and note 11 of the notes to the consolidated financial statements (unaudited) included in this report, in note 22 of the notes to the consolidated financial statements included in our 2021 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 public filings which can be accessed at the SEC 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 2021 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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Supplemental information regarding our risk factors
The current global economic climate, specifically as it relates to the Ukraine War, has enhanced the risks described in our 2021 Form 20-F, specifically under “Risk Factors,” and the supplemental information below should be read in conjunction with those risks.
As a provider of life-sustaining healthcare services for dialysis patients, we are continuing to provide dialysis services and to supply our clinics with dialysis products in both Russia and Ukraine to the best of our ability in spite of the current war in the region and notwithstanding extensive economic sanctions imposed on Russia by numerous governments in response to the war. In addition to risks related to the further development of our activities in the two countries, considerable uncertainties arise within this highly dynamic situation, in particular from a possible deterioration of the global macroeconomic outlook. While the direct and indirect impacts related to the Ukraine War are difficult to predict at the present time, the current, significant macroeconomic inflationary environment, including materially increasing energy prices, has resulted in and could continue to lead to, among other consequences, material increases in costs for energy, supplies and transportation. A continued disruption or discontinuation of energy supplies from Russia may increase these impacts and could have additional material adverse effects on our business such as a potential closure of certain of our production sites or significantly increased costs incurred due to a switch to alternative energy sources. Furthermore, we could be impacted by pressure on or material increases in interest rates, particularly if accompanied by more difficult access to capital in the financial markets and currency devaluations as a result of the geopolitical situation. Additionally, the Ukraine War has increased the risk of cyber security attacks against our systems and data. Overall, the aforementioned factors could have a material negative impact on our net assets, financial position and results of operations. While we still consider the Risk Factor “We could be adversely affected if we experience shortages of goods or material price increases from our suppliers, or an inability to access new and improved products and technology” to be a medium level risk in the short-term, we believe that the Ukraine War has increased both the likelihood and potential impact of the risks and exposures described in the 2021 20-F.
At the time of this report and unchanged from our assessment in the 2021 20-F, we have not identified any risks that could jeopardize our continued existence.
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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 care and related services to persons who suffer from End-Stage Kidney Disease (“ESKD”) 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, and 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 150 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, cardiovascular and endovascular specialty services as well as ambulatory surgery center services, physician nephrology and cardiology services and ambulant treatment services. We estimate that the size of the global dialysis market was approximately €79 billion in 2021. 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 chronic kidney disease; 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.
On August 24, 2022, we completed a three-way business combination including Fresenius Health Partners, Inc. (“FHP”), the value-based care division of Fresenius Medical Care North America. The transaction, first announced in March 2022, received regulatory clearance and satisfied other customary closing conditions in the U.S. The new company, which will operate under the InterWell Health brand (“InterWell Health”), creates an innovative, stand-alone entity combining FHP's expertise in kidney care value-based contracting and performance, InterWell Health LLC's clinical care models and network of around 1,700 nephrologists and Cricket Health, Inc.'s tech-enabled care model that utilizes its proprietary informatics, StageSmart™ and patient engagement platforms and will target the management of care for more than 270,000 people with kidney disease with more than $11 billion (€11 billion as of the transaction date) in costs under management by 2025. For further information, see “II. Discussion of measures — Net leverage ratio (Non-IFRS Measure)” below and note 2 of the notes to the consolidated financial statements (unaudited) included in this report.
We have extended the service agreement of Franklin W. Maddux, MD, as Global Chief Medical Officer until December 31, 2027 (previously set to expire at the end of 2022). In connection with that extension, the supervisory board extended Mr. Maddux’s term limit as a Management Board member for the same period. The latter extension required an exception to our self-set age limit for Management Board members, which the supervisory board granted in recognition of Mr. Maddux’s extensive knowledge and the importance of the Global Medical Office in our new business model.
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, 2022, approximately 30% 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 the Centers for Medicare and Medicaid (“CMS”). Legislative changes could affect Medicare 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” (temporarily suspended from May 1, 2020 through March 31, 2022, after which time a 1% reduction became effective from April 1 to June 30, 2022 and the full 2% sequester resumed on July 1, 2022) 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”). Please 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, to encompass substantially all goods and services provided during the dialysis treatment. MIPPA further created |
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the ESRD Quality Incentive Program (“QIP”) which provides that dialysis facilities in the United States that fail to achieve annual quality standards established by CMS could have base payments reduced in a subsequent year by up to 2%. |
● | Additionally, as a result of the Budget Control Act of 2011 (“BCA”) and subsequent activity in Congress, U.S. Sequestration ($1.2 trillion in across-the-board spending cuts in discretionary programs) took effect on March 1, 2013 and is expected to continue through 2030. In particular, a 2% reduction to Medicare payments took effect on April 1, 2013 and continues in force. The 2% sequestration was temporarily suspended several times subsequent to May 1, 2020. In March 2021, President Biden signed the American Rescue Plan Act of 2021 (the “American Rescue Plan Act”) which the Congressional Budget Office has estimated will result in budget deficits that will require a 4% reduction in Medicare program payments for 2022 under the Statutory Pay-As-You-Go Act of 2010 (“Statutory PAYGO”) unless Congress and the President take action to waive the Statutory PAYGO reductions. In December 2021, Congress passed, and President Biden signed into law, the Protecting Medicare and American Farmers from Sequester Cuts Act impacting payments for all Medicare Fee-for-Service claims and extending the sequestration suspension through March 31, 2022 with a 1% reduction effective thereafter from April 1 to June 30, 2022 and a return to the full 2% sequester on July 1, 2022, as noted above. Spending cuts pursuant to U.S. Sequestration have adversely affected our operating results in the past and, with the suspension having been lifted, will continue to do so. |
● | On June 21, 2022, CMS issued a proposed rule for the ESRD PPS rate for calendar year (“CY”) 2023. The proposed base rate per treatment for CY 2023 is $264.09, which represents a 2.4% increase from the CY 2022 base rate of $257.90. The proposed increase of 2.4% is based on a proposed market basket increase of 2.8% partially offset by a proposed 0.4% multifactor productivity adjustment that is mandated by the ACA. CMS is proposing to update the outlier methodology to account for historical trends in spending as well as to better account for the introduction of new and innovative products under the transitional add-on payment adjustment for new and innovative equipment and supplies (“TPNIES”) and ESRD PPS transitional drug add-on payment adjustment (“TDAPA”) policies. CMS estimates that, on average, large dialysis organizations would receive a 3.0% increase in payments in CY 2023 compared to CY 2022 under this proposed rule. The Acute Kidney Injury payment rate for CY 2023 is to equal the CY 2023 ESRD PPS base rate. CMS reviewed three TPNIES applications for CY 2023. CMS estimates total TPNIES payment amounts to facilities in CY 2023 would be approximately $2.5 M. For CY 2023, the proposed pre-adjusted per-treatment amount will be reduced by an average per-treatment offset amount of $9.73. |
● | Under the ESRD QIP, CMS assesses the total performance of each facility on a set of measures specified per payment year (“PY”) and applies up to a 2 percent payment reduction to facilities that do not meet a minimum total performance score (“TPS”). In the CY 2023 proposed rule, CMS proposed to adopt a special scoring and payment policy for PY 2023 of the ESRD QIP to address the issues in the scoring system caused by the impact of the COVID-19 Public Health Emergency on QIP data, including the use of pre-pandemic data from CY 2019 as the baseline period for the PY 2023 ESRD QIP and for subsequent years and proposes a pause on certain measures for scoring and payment adjustment purposes. CMS is also seeking input on potentially adding quality measures for home dialysis, expanding reporting programs to better understand healthcare disparities and including two social drivers of health screening measures. Additionally, CMS proposes to express clinical measure results as rates beginning with PY 2024 ESRD QIP. |
● | On July 15, 2022, CMS announced the CY 2023 proposed rule for hospital outpatient and ambulatory surgery center (“ASC”) payment systems. The proposed rule to update the ASC payment system for CY 2023 generally increases the reimbursement rates for the range of procedures provided in an ASC. The proposed average increase is 2.7% compared to the prior year. CMS proposed to expand the categories of service subject to the prior authorization process within the ASC. For CY 2023, CMS proposed a new ASC payment policy resulting in higher payments when a code combination is more complex and represents a higher cost version of the performed procedures. On July 7, 2022, CMS also updated the proposed Physician Fee Schedule for CY 2023. The proposed CY 2023 Physician Fee Schedule conversion factor is $33.08, a decrease of $1.53 from the CY 2022 physician fee schedule conversion factor of $34.61. |
● | On May 9th, 2022, CMS issued a final rule in which the rules for calculating the accrual of maximum out-of-pocket costs (“MOOP”) were changed. Specifically, CMS specified that, beginning on June 28th, 2022, the MOOP limit in Medicare Advantage, also known as Medicare Part C, plans 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” plans) (after which the plan pays 100 percent of Medicare Advantage costs for Part A and Part B services) must be calculated based on the accrual of all cost-sharing in the plan benefit, regardless of whether that cost-sharing is paid by the beneficiary, Medicaid, other secondary insurance, or remains unpaid (including cost-sharing that remains unpaid because of State limits on the amounts paid for Medicare cost-sharing and dually eligible individuals’ exemption from Medicare cost-sharing). CMS believes the change will result in more equitable payment for Medicare Advantage providers, including dialysis providers, serving dually eligible beneficiaries. |
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 Medicare or commercial reimbursement rates, including under Medicare Advantage plans, or patient access to commercial insurance
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plans, including Medicare Advantage, 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. Additionally, in Marietta Memorial Hospital Employee Health Benefit Plan v. DaVita Inc., the Supreme Court ruled against DaVita, Inc. in favor of a self-funded employer-sponsored health plan that provided only out-of-network dialysis reimbursements to individuals with ESKD. While the Medicare Secondary Payer statute has long been interpreted as requiring private plans to provide for a 30-month coordination period for individuals diagnosed with ESKD (with Medicare serving as the secondary payer), the decision creates the potential that other plans may follow suit in limiting the dialysis benefits offered. While we do not expect this to significantly impact plans for 2023, absent legislative action, the ruling could have implications in 2024 and beyond. In July and August 2022, the Restore Protections for Dialysis Patients Act (H.R. 8594/S.4750) was introduced in both the House and Senate. If passed, it would restore the Medicare Secondary Payer Act’s original intent requiring the 30-month coordination period be available to individuals diagnosed with ESKD. For additional information regarding these regulatory matters, see “Information on the Company—Regulatory and Legal Matters—Health Care Reform” in our 2021 Form 20-F.
For additional information, see “Risk Factors” included in our 2021 Form 20-F.
Premium assistance programs
The operation of charitable assistance programs such as that offered by the American Kidney Fund is receiving increased attention 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.
Participation in new Medicare payment arrangements
Under CMS’s Comprehensive ESRD Care Model (the “Model”), dialysis providers and physicians formed entities known as ESRD Seamless Care Organizations (“ESCOs”) as part of a payment and care delivery pilot program that ended March 31, 2021 which sought to deliver better health outcomes for Medicare ESKD patients while lowering CMS’s costs. Following our initial participation in six ESCOs, we ultimately expanded our participation in the Model to 23 ESCOs formed at our dialysis facilities. ESCOs that achieved the program’s minimum quality thresholds and generated reductions in CMS’s cost of care above certain thresholds for the ESKD patients covered by the ESCO received a share of the cost savings, adjusted based on the ESCO’s performance on certain quality metrics. ESCOs may also owe payments to CMS if actual costs of care rise above set thresholds. As of March 2021, approximately 34,800 patients were aligned to ESCOs in which we participated.
In November 2017, we announced the results from the first performance year from our ESCOs. The results, which cover the period from October 2015 through December 2016, show improved health outcomes for patients receiving coordinated care through the ESCOs. This success was validated by an independent report, which showed a nearly 9% decrease in hospitalization rates for these patients during the same time. In the second performance year (CY 2017) the Company’s ESCOs together generated more than $66.7 M (€59.0 M) in gross savings, an average 3.4% reduction in expenditures per patient. For the third performance year (CY 2018), CMS published the final settlement reports on August 14, 2020. In total the Company’s ESCOs produced more than $66.1 M (€56.0 M) in gross savings, an average 1.9% reduction in expenditures per patient. For the fourth performance year (CY 2019), CMS published the final settlement reports on October 31, 2020. In total, the Company’s ESCOs produced more than $10.8 M (€9.6 M) in gross losses, an average 0.3% increase in expenditures per patient. For the fifth performance year (CY 2020), CMS gave each ESCO the options to (a) extend participation in the program through March 31, 2021, and/or to (b) accept the following financial changes: (i) reduce 2020 downside risk by reducing shared losses by proportion of months during the COVID-19 Public Health Emergency as promulgated under the Public Health Services Act, (ii) cap gross savings upside potential at 5% gross savings, (iii) remove COVID-19 inpatient episodes, and (iv) remove the 2020 financial guarantee requirement. All of our affiliated ESCOs signed amendments to extend participation in the program through March 31, 2021 and 22 of our ESCOs accepted the financial changes related to COVID-19. The Model ended on March 31, 2021. We anticipate that CMS will publish final settlement reports for the last performance year during the fourth quarter of 2022.
We have also entered into value and risk-based care programs with private payors to provide care to commercial and Medicare Advantage ESKD and CKD patients. Under these payment arrangements, our financial performance is based on our ability to manage a defined scope of medical costs within certain parameters for clinical outcomes.
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 ESRD
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Treatment Choices (“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, 2022, 986 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”), will be 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).
On June 28, 2022, CMS proposed refinements to the ETC model, including a change to the requirements related to flexibilities regarding furnishing and billing kidney disease patient education services under the ETC model. CMS has also discussed its intent to publish participant-level performance data.
Pursuant to the Executive Order, the Secretary of HHS also announced voluntary payment models, Kidney Care First (“KCF”) and Comprehensive Kidney Care Contracting (“CKCC”) model (graduated, professional and global), which aim to build on the existing Comprehensive ESRD Care model. The voluntary models create financial incentives for health care providers to manage care for Medicare beneficiaries with chronic kidney disease stages 4 and 5 and with ESKD, 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. Under the global model, the KCE is responsible for 100 percent 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 percent 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. Once implemented, 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. CMS will require these newly accepted KCEs to decide in the fourth quarter of 2022 whether they will move forward during the second performance year to start assuming financial risk as of January 1, 2023.
We are presently unable to predict the effects on our business of the ETC payment model and the voluntary payment models.
8
FRESENIUS MEDICAL CARE AG & Co. KGaA
Company structure
Our operating and reportable segments are the North America Segment, the EMEA Segment, the Asia-Pacific Segment and the Latin America Segment. The operating segments are determined based upon how we manage our businesses with geographical responsibilities. All segments are primarily engaged in providing health care services and the distribution of products and equipment for the treatment of ESKD and other extracorporeal therapies. 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. We do not include income taxes as we believe taxes are outside the segments’ control. Financing is a corporate function which our segments do not control. Therefore, we do not include interest expense relating to financing as a segment measurement. Similarly, we do not allocate certain costs which relate primarily to certain headquarters’ overhead charges, including accounting and finance as well as certain legal and IT costs, because we believe that these costs are also not within the control of the individual segments. Production of products, production asset management, quality and supply chain management as well as procurement related to production are centrally managed. Products transferred to the segments are transferred at cost; therefore, no internal profit is generated. The associated internal revenue for the product transfers and their elimination are recorded as corporate activities. Capital expenditures for production are based on the expected demand of the segments and consolidated profitability considerations. Our global research and development team as well as our Global Medical Office, which seek to optimize medical treatments and clinical processes within the Company, are also centrally managed. These corporate activities do not fulfill the definition of a segment according to IFRS 8, Operating Segments. In addition, certain revenues, investments and intangible assets, as well as any related expenses, are not allocated to a segment but accounted for as Corporate. Accordingly, all of these items are excluded from our analysis of segment results and are discussed below in the discussion of our consolidated results of operations. See note 13 of the notes to the consolidated financial statements (unaudited) found elsewhere in this report for a further discussion on our operating segments.
As announced on November 2, 2021, we entered the next phase of our program focusing on the transformation of our global operating model to strengthen profitability and enable execution on our mid-term strategy (“FME25 Program”): the transformation of our operating model to provide the base for future sustainable growth in the medium-term. In the new operating model, the Company intends to reorganize its business into two global operating segments.
We are consolidating our health care products business, including research and development, manufacturing, supply chain and commercial operations, as well as supporting functions, such as regulatory and quality management, under a global umbrella. The products business will be organized along the three treatment modalities that we serve: In-center, Home and Critical Care. Our global health care services business will be combined into one segment.
Our Global Medical Office will continue to leverage the vertically integrated approach to optimize clinical outcomes for our patients. General and administrative functions will also be globalized using a three pillars model of business partnering, centers of excellence and global shared services.
We expect to complete the implementation of the new model around 2023.
9
FRESENIUS MEDICAL CARE AG & Co. KGaA
II. Discussion of measures
Non-IFRS measures
Certain of the following key performance indicators and other financial information as well as discussions and analyses set out in this report include measures that are not defined by IFRS (“Non-IFRS Measure”). We believe this information, along with comparable IFRS 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.
Constant Exchange Rates or Constant Currency (Non-IFRS Measure)
Our presentation of some key performance indicators and other financial measures used in this report such as changes in revenue, operating income and net income attributable to shareholders of FMC AG & Co. KGaA (or “net income”) includes the impact of translating local currencies to our reporting currency for financial reporting purposes. We calculate these Non-IFRS financial measures at constant exchange rates in our publications to show changes in our revenue, operating income, net income attributable to shareholders of FMC AG & Co. KGaA and other items without giving effect to period-to-period currency fluctuations. Under IFRS, 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.”
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 FMC AG & Co. KGaA 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 FMC AG & Co. KGaA and other items prepared in accordance with IFRS, and |
(2) | Constant Currency changes in revenue, operating income, net income attributable to shareholders of FMC AG & Co. KGaA 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 FMC AG & Co. KGaA and other items prepared in accordance with IFRS. We present the growth rate derived from non-IFRS measures next to the growth rate derived from IFRS measures such as revenue, operating income, net income attributable to shareholders of FMC AG & Co. KGaA 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.
10
FRESENIUS MEDICAL CARE AG & Co. KGaA
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 below (see “Net leverage ratio (Non-IFRS Measure)”). 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 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, | |||||
2022 |
| 2022 | 2022 |
| 2022 |
| 2021 |
| 2021 | |
Total assets |
| 38,406 | 36,070 | 34,724 | 34,367 |
| 33,831 | |||
Plus: Cumulative goodwill amortization and impairment loss |
| 699 | 665 | 641 | 612 |
| 604 | |||
Minus: Cash and cash equivalents |
| (1,114) | (1,025) | (1,173) | (1,482) |
| (1,562) | |||
Minus: Loans to related parties |
| (3) | (1) | (4) | (15) |
| (4) | |||
Minus: Deferred tax assets |
| (328) | (310) | (299) | (315) |
| (374) | |||
Minus: Accounts payable to unrelated parties |
| (828) | (837) | (790) | (736) |
| (706) | |||
Minus: Accounts payable to related parties |
| (81) | (102) | (70) | (121) |
| (94) | |||
Minus: Provisions and other current liabilities (1) |
| (3,488) | (3,222) | (3,188) | (3,319) |
| (3,516) | |||
Minus: Income tax liabilities |
| (242) | (207) | (194) | (174) |
| (224) | |||
Invested capital |
| 33,021 | 31,031 | 29,647 | 28,817 |
| 27,955 | |||
Average invested capital as of September 30, 2022 |
| 30,094 |
|
| ||||||
Operating income |
| 1,609 |
|
| ||||||
Income tax expense (2) |
| (496) |
|
| ||||||
NOPAT |
| 1,113 |
|
|
Adjustments to average invested capital and ROIC
in € M, except where otherwise specified
| September 30, | June 30, | March 31, | December 31, |
| September 30, | ||||
2022 |
| 2022 | 2022(3) |
| 2022(3) |
| 2021(3) |
| 2021(3) | |
Total assets |
| — | 599 | 561 | 549 |
| 652 | |||
Minus: Cash and cash equivalents |
| — | (55) | (52) | (51) |
| (50) | |||
Minus: Accounts payable to unrelated parties | — | (9) | (8) | (8) | (8) | |||||
Minus: Provisions and other current liabilities (1) |
| — | (4) | (4) | (3) |
| (3) | |||
Invested capital |
| — | 531 | 497 | 487 |
| 591 | |||
Adjustment to average invested capital as of September 30, 2022 |
| 421 |
|
| ||||||
Adjustment to operating income (3) |
| (31) |
|
| ||||||
Adjustment to income tax expense (3) |
| 10 |
|
| ||||||
Adjustment to NOPAT |
| (21) |
|
|
11
FRESENIUS MEDICAL CARE AG & Co. KGaA
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, | ||||
2022 |
| 2022 | 2022(3) |
| 2022(3) |
| 2021(3) |
| 2021(3) | |
Total assets |
| 38,406 | 36,669 | 35,285 | 34,916 |
| 34,483 | |||
Plus: Cumulative goodwill amortization and impairment loss |
| 699 | 665 | 641 | 612 |
| 604 | |||
Minus: Cash and cash equivalents |
| (1,114) | (1,080) | (1,225) | (1,533) |
| (1,612) | |||
Minus: Loans to related parties |
| (3) | (1) | (4) | (15) |
| (4) | |||
Minus: Deferred tax assets |
| (328) | (310) | (299) | (315) |
| (374) | |||
Minus: Accounts payable to unrelated parties |
| (828) | (846) | (798) | (744) |
| (714) | |||
Minus: Accounts payable to related parties |
| (81) | (102) | (70) | (121) |
| (94) | |||
Minus: Provisions and other current liabilities (1) |
| (3,488) | (3,226) | (3,192) | (3,322) |
| (3,519) | |||
Minus: Income tax liabilities |
| (242) | (207) | (194) | (174) |
| (224) | |||
Invested capital |
| 33,021 | 31,562 | 30,144 | 29,304 |
| 28,546 | |||
Average invested capital as of September 30, 2022 |
| 30,514 |
| |||||||
Operating income (3) |
| 1,578 |
|
| ||||||
Income tax expense (2), (3) |
| (486) |
|
| ||||||
NOPAT |
| 1,092 |
|
| ||||||
ROIC |
| 3.6% |
|
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, | |||
2021 |
| 2021 |
| 2021 |
| 2021 |
| 2021 |
| 2020 |
Total assets |
| 34,367 | 33,831 | 32,987 |
| 33,159 |
| 31,689 | ||
Plus: Cumulative goodwill amortization and impairment loss |
| 612 | 604 | 602 |
| 598 |
| 583 | ||
Minus: Cash and cash equivalents |
| (1,482) | (1,562) | (1,408) |
| (1,073) |
| (1,082) | ||
Minus: Loans to related parties |
| (15) | (4) | (6) |
| (1) |
| (1) | ||
Minus: Deferred tax assets |
| (315) | (374) | (359) |
| (333) |
| (351) | ||
Minus: Accounts payable to unrelated parties |
| (736) | (706) | (685) |
| (635) |
| (732) | ||
Minus: Accounts payable to related parties |
| (121) | (94) | (102) |
| (105) |
| (95) | ||
Minus: Provisions and other current liabilities (1) |
| (3,319) | (3,516) | (3,528) |
| (3,436) |
| (3,180) | ||
Minus: Income tax liabilities |
| (174) | (224) | (218) |
| (232) |
| (197) | ||
Invested capital |
| 28,817 | 27,955 | 27,283 |
| 27,942 |
| 26,634 | ||
Average invested capital as of December 31, 2021 |
| 27,725 |
|
|
|
| ||||
Operating income |
| 1,852 |
|
|
|
| ||||
Income tax expense (2) |
| (490) |
|
|
|
| ||||
NOPAT |
| 1,362 |
|
|
|
|
Adjustments to average invested capital and ROIC
in € M, except where otherwise specified
| December 31, |
| September 30, |
| June 30, |
| March 31, |
| December 31, | |
2021 |
| 2021 |
| 2021 (3) |
| 2021 (3) |
| 2021 (3) |
| 2020 (3) |
Total assets |
| — |
| 115 |
| 186 |
| 189 |
| 291 |
Minus: Cash and cash equivalents |
| — |
| — |
| — |
| — |
| (3) |
Minus: Provisions and other current liabilities (1) |
| — |
| — |
| — |
| — |
| (6) |
Invested capital |
| — |
| 115 |
| 186 |
| 189 |
| 282 |
Adjustment to average invested capital as of December 31, 2021 |
| 154 |
|
|
|
|
|
|
| |
Adjustment to operating income (3) |
| 12 |
|
|
|
|
|
|
|
|
Adjustment to income tax expense (3) |
| (3) |
|
|
|
|
|
|
|
|
Adjustment to NOPAT |
| 9 |
|
|
|
|
|
|
|
|
12
FRESENIUS MEDICAL CARE AG & Co. KGaA
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, | |
2021 |
| 2021 |
| 2021 (3) |
| 2021 (3) |
| 2021 (3) |
| 2020 (3) |
Total assets |
| 34,367 |
| 33,946 |
| 33,173 |
| 33,348 |
| 31,980 |
Plus: Cumulative goodwill amortization and impairment loss |
| 612 |
| 604 |
| 602 |
| 598 |
| 583 |
Minus: Cash and cash equivalents |
| (1,482) |
| (1,562) |
| (1,408) |
| (1,073) |
| (1,085) |
Minus: Loans to related parties |
| (15) |
| (4) |
| (6) |
| (1) |
| (1) |
Minus: Deferred tax assets |
| (315) |
| (374) |
| (359) |
| (333) |
| (351) |
Minus: Accounts payable to unrelated parties |
| (736) |
| (706) |
| (685) |
| (635) |
| (732) |
Minus: Accounts payable to related parties |
| (121) |
| (94) |
| (102) |
| (105) |
| (95) |
Minus: Provisions and other current liabilities (1) |
| (3,319) |
| (3,516) |
| (3,528) |
| (3,436) |
| (3,186) |
Minus: Income tax liabilities |
| (174) |
| (224) |
| (218) |
| (232) |
| (197) |
Invested capital |
| 28,817 |
| 28,070 |
| 27,469 |
| 28,131 |
| 26,916 |
Average invested capital as of December 31, 2021 |
| 27,879 |
|
|
|
|
|
|
| |
Operating income (3) |
| 1,864 |
|
|
|
|
|
|
|
|
Income tax expense (2), (3) |
| (493) |
|
|
|
|
|
|
|
|
NOPAT |
| 1,371 |
|
|
|
|
|
|
|
|
ROIC |
| 4.9% |
|
|
|
|
|
|
|
(1) | 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. |
(2) | Adjusted for noncontrolling partnership interests. |
(3) | Including adjustments for acquisitions and divestitures made during the last twelve months with a purchase price above a €50 M threshold. |
13
FRESENIUS MEDICAL CARE AG & Co. KGaA
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.
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, reducing debt financing or for repurchasing shares.
For a reconciliation of cash flow performance indicators for the nine months ended September 30, 2022 and 2021 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 (earnings before interest, taxes, depreciation and amortization), 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 7 of the notes to the consolidated financial statements (unaudited) included in this report), |
● | non-cash charges, |
● | impairment loss, and |
● | special items, including: |
i. | costs related to our FME25 Program, |
ii. | the impact from applying hyperinflationary accounting under IAS 29, Financial Reporting in Hyperinflationary Economies (“IAS 29”), in Turkiye (“Hyperinflation in Turkiye”), |
iii. | the impact from the remeasurement of our investment in Humacyte, Inc. (“Humacyte Investment Remeasurement”), |
iv. | the net gain related to the InterWell Health business combination, including the remeasurement gain of our investment, prior to the transaction, in InterWell Health LLC, the impairment of certain long-lived assets belonging to Acumen Physician Solutions, LLC which was transferred to InterWell Health as part of the transaction and certain transaction-related costs (“Net Gain Related to InterWell Health”) (for further information regarding the InterWell Health business combination, see “I. Overview,” above, and note 2 of the notes to the consolidated financial statements (unaudited) included in this report), and |
v. | bad debt expense in Russia and Ukraine and accruals for certain risks associated with allowances on inventories related to the Ukraine War (“Impacts Related to the War in Ukraine”). Although to date the Ukraine War has had minimal impact on our impairment testing of goodwill in the EMEA Segment, as we continue to treat patients and provide health care products to our clinics in those countries, receive reimbursements and generate cash flows, it has had an impact on the valuation of certain assets and receivables as a result of the ongoing hostilities. |
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.
14
FRESENIUS MEDICAL CARE AG & Co. KGaA
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 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, 2022 and December 31, 2021, see “III. Results of operations, financial position and net assets - Financial position - Sources of Liquidity.”
15
FRESENIUS MEDICAL CARE AG & Co. KGaA
III. Results of operations, financial position and net assets
The following sections summarize our 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
Segment data (including Corporate)
in € M
| For the three months ended |
| For the nine months ended | |||||
September 30, | September 30, | |||||||
| 2022 |
| 2021 |
| 2022 |
| 2021 | |
| ||||||||
Total revenue |
|
|
|
|
| |||
North America Segment |
| 3,556 | 3,080 | 10,021 | 8,931 | |||
EMEA Segment |
| 720 | 671 | 2,121 | 2,033 | |||
Asia-Pacific Segment |
| 565 | 501 | 1,588 | 1,458 | |||
Latin America Segment |
| 243 | 178 | 633 | 508 | |||
Corporate |
| 12 | 11 | 38 | 42 | |||
Total |
| 5,096 | 4,441 | 14,401 | 12,972 | |||
Operating income |
|
| ||||||
North America Segment |
| 469 | 446 | 1,113 | 1,242 | |||
EMEA Segment |
| 48 | 79 | 169 | 232 | |||
Asia-Pacific Segment |
| 85 | 86 | 255 | 256 | |||
Latin America Segment |
| 11 | 4 | 16 | 14 | |||
Corporate |
| (141) | (110) | (393) | (341) | |||
Total |
| 472 | 505 | 1,160 | 1,403 | |||
Interest income |
| 16 | 16 | 43 | 45 | |||
Interest expense |
| (92) | (84) | (260) | (259) | |||
Income tax expense |
| (112) | (105) | (242) | (274) | |||
Net income |
| 284 | 332 | 701 | 915 | |||
Net income attributable to noncontrolling interests |
| (54) | (59) | (166) | (174) | |||
Net income attributable to shareholders of FMC AG & Co. KGaA |
| 230 | 273 | 535 | 741 |
Revenue and operating income generated in countries outside the eurozone are subject to currency fluctuations. The table below summarizes the development of the euro against the U.S. dollar, as well as the revenue and the operating income generated in U.S. dollars, as a percentage of the consolidated results, for the three- and nine- month periods ended September 30, 2022 and 2021:
Currency development and portion of total revenue and operating income
| For the three months ended | For the nine months ended | ||||||
September 30, | September 30, | |||||||
| 2022 |
| 2021 |
| 2022 |
| 2021 | |
Currency development of euro against the U.S. dollar | positive impact | relatively unaffected | positive impact | negative impact | ||||
Percentage of revenue generated in U.S. dollars |
| 70% | 69% | 70% | 69% | |||
Percentage of operating income generated in U.S. dollars |
| 99% | 88% | 96% | 89% |
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FRESENIUS MEDICAL CARE AG & Co. KGaA
Three months ended September 30, 2022 compared to three months ended September 30, 2021
Interim consolidated financials
Performance indicators for the interim consolidated financial statements
Change in % | ||||||||||
For the three months ended | Currency | |||||||||
September 30, | translation | Constant | ||||||||
| 2022 |
| 2021 |
| As reported |
| effects |
| Currency(1) | |
|
|
|
|
| ||||||
Revenue in € M | 5,096 |
| 4,441 |
| 15% | 12% | 3% | |||
Health care services | 4,082 |
| 3,530 |
| 16% | 14% | 2% | |||
Health care products | 1,014 |
| 911 |
| 11% | 7% | 4% | |||
Number of dialysis treatments | 13,220,000 |
| 13,297,287 |
| (1%) | |||||
Same Market Treatment Growth (2) | (1.3%) | (2.4%) | ||||||||
Gross profit in € M | 1,359 |
| 1,267 | 7% | 11% | (4%) | ||||
Gross profit as a % of revenue | 26.7% | 28.5% | ||||||||
Selling, general and administrative costs in € M | 990 |
| 731 | 35% | (13%) | 22% | ||||
Selling, general and administrative costs as a % of revenue | 19.4% | 16.5% | ||||||||
Operating income in € M | 472 |
| 505 | (7%) | 10% | (17%) | ||||
Operating income margin | 9.3% | 11.4% | ||||||||
Net income attributable to shareholders of FMC AG & Co. KGaA in € M | 230 |
| 273 |
| (16%) | 8% | (24%) | |||
Basic earnings per share in € | 0.78 |
| 0.93 |
| (16%) | 8% | (24%) |
(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”). |
Health care services revenue increased by 16% as compared to the three months ended September 30, 2021 (+2% at Constant Exchange Rates) driven by a positive impact from foreign currency translation (+14%) and organic growth (+2%), despite impacts from excess mortality rates among patients due to COVID-19 in certain of our operating segments which are further described in the discussions of our segments below.
Dialysis treatments decreased by 1% as a result of negative Same Market Treatment Growth (-1%) and the effect of closed or sold clinics (-1%), partially offset by contributions from acquisitions (+1%). Excess mortality rates among our patients due to COVID-19 contributed significantly to the decreases in treatments and Same Market Treatment Growth.
At September 30, 2022, we owned or operated 4,153 dialysis clinics compared to 4,151 dialysis clinics at September 30, 2021. During the three months ended September 30, 2022, we acquired 2 dialysis clinic, opened 11 dialysis clinics and combined or closed 23 clinics. The number of patients treated in dialysis clinics that we own or operate remained relatively stable at 344,593 as of September 30, 2022 (September 30, 2021: 344,872). Excess mortality rates among patients due to COVID-19 also significantly impacted the number of patients we treated.
Health care product revenue increased by 11% (+4% at Constant Exchange Rates), driven by a positive impact from foreign currency translation as well as higher sales of in-center disposables and renal pharmaceuticals, partially offset by lower sales of machines for chronic treatment (including the effect of a temporary pause in shipping of new dialysis machines in the U.S.) (see note 11 of the notes to the consolidated financial statements (unaudited) included in this report).
Gross profit increased by 7% (-4% at Constant Exchange Rates), primarily driven by a favorable impact from foreign currency translation effects (mainly in the North America Segment), government relief funding available for health care providers affected by the COVID-19 pandemic, which offset certain eligible costs, (North America Segment), favorable foreign currency transaction effects (Asia Pacific Segment, EMEA Segment and Latin America Segment), partially offset by higher personnel expense (primarily in the North America Segment) and inflationary and supply chain cost increases (across all regions).
Selling, general and administrative (“SG&A”) expense increased by 35% (+22% at Constant Exchange Rates), primarily driven by a negative impact from foreign currency translation (North America Segment, Asia-Pacific Segment, Corporate and Latin America Segment), costs related to the InterWell Health business combination in the North America Segment (“InterWell Health Costs”) (see note 2 of the notes to the consolidated financial statements (unaudited) included in this report), costs associated with the FME 25 Program (Corporate, EMEA Segment and North America Segment) and an unfavorable impact from the remeasurement of investments (primarily
17
FRESENIUS MEDICAL CARE AG & Co. KGaA
driven by the Humacyte Investment Remeasurement in the North America Segment), partially offset by increased income attributable to a consent agreement on certain pharmaceuticals in the North America Segment.
Research and development expenses increased by 17% to €61 M from €52 M. The increase was largely driven by a negative impact from foreign currency translation and research and development activities at NxStage Medical, Inc., our subsidiary, and in the field of regenerative medicine.
Income from equity method investees decreased by 17% to €17 M from €21 M. The decrease was primarily driven by lower earnings from Vifor Fresenius Medical Care Renal Pharma Ltd. (“VFMCRP”) and a negative impact from foreign currency translation.
We recorded a remeasurement gain of our prior at-equity investment in InterWell Health LLC in the amount of €147 M (September 30, 2021: €0). For further information regarding the InterWell Health business combination, see “I. Overview” and “II. Discussion of measures – Net leverage ratio (Non-IFRS Measure),” above, as well as note 2 of the notes to the consolidated financial statements (unaudited) included in this report.
Operating income decreased by 7% (-17% at Constant Exchange Rates), largely driven by the combined effects of the items discussed within gross profit, SG&A expense and the InterWell Health remeasurement gain as well as a positive impact from foreign currency translation. We have seen unprecedented challenges in the labor market in the U.S., resulting in staff shortages, high turnover rates and meaningfully higher costs, including higher costs due to an increased reliance on contracted labor. These challenges continue to impact growth, specifically in U.S. health care services where labor constraints have affected our ability to increase treatment volumes. These impacts, combined with the current uncertainty in the macroeconomic environment, driving inflationary cost increases and supply chain constraints, have had an adverse effect on our results of operations during 2022 and we expect them to continue for the remainder of the year.
Net interest expense increased by 12% to €76 M from €68 M, primarily due a negative impact from foreign currency translation, unfavorable effects from foreign currency swaps and lower interest income related to royalty receivables, partially offset by refinancing activities (including the issuance of bonds in prior periods at lower interest rates).
Income tax expense increased by 7% to €112 M from €105 M. The effective tax rate increased to 28.4% from 24.1% for the same period of 2021 largely driven by an increase in the proportionate share of non-deductible expenses as compared to taxable income and higher tax provisions related to tax law changes. Non-tax deductible expenses also increased due to the InterWell Health business combination and hyperinflation in Argentina and Turkiye. The increase in the effective tax rate was partially offset by a larger portion of tax-free income attributable to noncontrolling interests compared to income before income taxes.
Net income attributable to noncontrolling interests decreased by 9% to €54 M from €59 M due to lower earnings in entities in which we have less than 100% ownership, partially offset by a negative impact from foreign currency translation.
Net income attributable to shareholders of FMC AG & Co. KGaA decreased by 16% (-24% at Constant Exchange Rates) as a result of the combined effects of the items discussed above, partially offset by a positive impact from foreign currency translation.
Basic earnings per share decreased by 16% (-24% at Constant Exchange Rates), primarily due to the decrease in net income attributable to shareholders of FMC AG & Co. KGaA described above. The average weighted number of shares outstanding for the period increased to 293.4 M on September 30, 2022 as compared to the prior year period (September 30, 2021: 293.0 M) primarily due to the exercise of stock options.
We employed 122,758 people (full-time equivalents) as of September 30, 2022 (September 30, 2021: 123,528). This 1% decrease was largely due to a prior year increase in production staff due to COVID-19 and a reduction in clinical staff as a result of a decrease in patients in certain regions.
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FRESENIUS MEDICAL CARE AG & Co. KGaA
The following discussions pertain to our operating and reportable segments and the measures we use to manage these segments.
North America Segment
Performance indicators for the North America Segment
Change in % | ||||||||||
For the three months ended | Currency | |||||||||
September 30, | translation | Constant | ||||||||
2022 | 2021 | As reported | effects | Currency(1) | ||||||
|
|
|
|
|
|
| ||||
Revenue in € M |
| 3,556 | 3,080 |
| 15% | 16% | (1%) | |||
Health care services |
| 3,269 | 2,810 |
| 16% | 16% | 0% | |||
Health care products |
| 287 | 270 |
| 6% | 15% | (9%) | |||
Number of dialysis treatments |
| 8,048,664 | 8,152,833 | (1%) |
| |||||
Same Market Treatment Growth |
| (2.5%) | (2.2%) |
| ||||||
Operating income in € M |
| 469 | 446 | 5% | 13% | (8%) | ||||
Operating income margin |
| 13.2% | 14.5% |
|
|
|
(1) | For further information on Constant Exchange Rates, see “II. Discussion of measures – Non–IFRS measures” above. |
Revenue
Health care services revenue increased by 16% (remained relatively stable at Constant Exchange Rates), driven by a positive impact from foreign currency translation (+16%) and contributions from acquisitions (+1%), partially offset by a decrease in organic growth (-1%) resulting from the effects of excess mortality rates among patients due to COVID-19.
Dialysis treatments decreased by 1% largely due to negative Same Market Treatment Growth (-3%), partially offset by contributions from acquisitions (+1%) and an increase in dialysis days (+1%). As of September 30, 2022, 208,275 patients, a decrease of 1% (September 30, 2021: 209,651), were treated in the 2,699 dialysis clinics (September 30, 2021: 2,683) that we own or operate in the North America Segment. Excess mortality rates among patients due to COVID-19 contributed significantly to the decreases in treatments, patients and Same Market Treatment Growth.
Health care product revenue increased by 6% (-9% at Constant Exchange Rates), driven by a positive impact from foreign currency translation, partially offset by lower sales of machines for chronic treatment (including the effect of a temporary pause in shipping of new dialysis machines in the U.S.) (see note 11 of the notes to the consolidated financial statements (unaudited) included in this report), products for acute care treatments and in-center disposables.
Operating income
Operating income increased by 5% (-8% at Constant Exchange Rates), primarily related to government relief funding available for health care providers affected by the COVID-19 pandemic, which offset certain eligible costs, a positive impact from foreign currency translation, the Net Gain Related to InterWell Health and increased income attributable to a consent agreement on certain pharmaceuticals, partially offset by higher personnel expense, an unfavorable impact from excess mortality rates among our patients due to COVID-19 as well as inflationary and supply chain cost increases. We have seen unprecedented challenges in the labor market in the U.S., resulting in staff shortages, high turnover rates and meaningfully higher costs, including higher costs due to an increased reliance on contracted labor. These challenges continue to impact growth and have affected our ability to increase treatment volumes. These impacts have had an adverse effect on our results of operations during 2022 and we expect them to continue for the remainder of the year.
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FRESENIUS MEDICAL CARE AG & Co. KGaA
EMEA Segment
Performance indicators for the EMEA Segment
Change in % | ||||||||||
For the three months ended | Currency | |||||||||
September 30, | translation | Constant | ||||||||
2022 | 2021 | As reported | effects | Currency(1) | ||||||
|
|
|
|
|
|
| ||||
Revenue in € M |
| 720 |
| 671 |
| 7% | (1%) | 8% | ||
Health care services |
| 377 |
| 346 |
| 9% | 1% | 8% | ||
Health care products |
| 343 |
| 325 |
| 6% | (2%) | 8% | ||
Number of dialysis treatments |
| 2,509,378 |
| 2,480,332 | 1% |
| ||||
Same Market Treatment Growth |
| 0.5% | (4.0%) |
| ||||||
Operating income in € M |
| 48 | 79 | (40%) | 1% | (41%) | ||||
Operating income margin |
| 6.6% | 11.7% |
|
|
|
|
(1) | For further information on Constant Exchange Rates, see “II. Discussion of measures – Non–IFRS measures” above. |
Revenue
Health care service revenue increased by 9% (+8% at Constant Exchange Rates), driven by an increase in organic growth, including the effects of Hyperinflation in Turkiye, (+8%) and a positive impact from foreign currency translation (+1%).
Dialysis treatments increased by 1% due to Same Market Treatment Growth (+1%). As of September 30, 2022, 66,293 patients, an increase of 1% (September 30, 2021: 65,336), were treated at the 814 dialysis clinics (September 30, 2021: 816) that we own or operate in the EMEA Segment.
Health care product revenue increased by 6% (+8% at Constant Exchange Rates), primarily due to higher sales of in-center disposables and renal pharmaceuticals (including the effects of Hyperinflation in Turkiye), partially offset by a negative impact from foreign currency translation and lower sales of acute cardiopulmonary products.
Operating income
Operating income decreased by 40% (-41% at Constant Exchange Rates), mainly due to inflationary cost increases (including Hyperinflation in Turkiye), costs associated with the FME 25 Program and lower income from certain equity method investees.
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FRESENIUS MEDICAL CARE AG & Co. KGaA
Asia-Pacific Segment
Performance indicators for the Asia-Pacific Segment
Change in % | ||||||||||
For the three months ended | Currency | |||||||||
September 30, | translation | Constant | ||||||||
2022 | 2021 | As reported | effects | Currency(1) | ||||||
|
|
|
|
|
|
| ||||
Revenue in € M |
| 565 |
| 501 |
| 13% | 6% | 7% | ||
Health care services |
| 256 |
| 239 |
| 7% | 2% | 5% | ||
Health care products |
| 309 |
| 262 |
| 18% | 9% | 9% | ||
Number of dialysis treatments |
| 1,225,891 | 1,201,888 |
| 2% | |||||
Same Market Treatment Growth |
| 2.5% | 3.4% | |||||||
Operating income in € M |
| 85 | 86 | (1%) | 1% | (2%) | ||||
Operating income margin |
| 15.1% | 17.2% |
|
|
(1) | For further information on Constant Exchange Rates, see “II. Discussion of measures – Non–IFRS measures” above. |
Revenue
Health care services revenue increased by 7% (+5% at Constant Exchange Rates), driven by an increase in organic growth (+5%), a positive impact from foreign currency translation (+2%) and contributions from acquisitions (+1%), partially offset by the effect of closed or sold clinics (-1%).
Dialysis treatments increased by 2% mainly due to Same Market Treatment Growth (+2%) and contributions from acquisitions (+1%), partially offset by the effect of closed or sold clinics (-1%). As of September 30, 2022, 33,800 patients, an increase of 1% (September 30, 2021: 33,434) were treated at the 397 dialysis clinics (September 30, 2021: 406) that we own or operate in the Asia-Pacific Segment.
Health care product revenue increased by 18% (+9% at Constant Exchange Rates), mainly due to a positive impact from foreign currency translation as well as higher sales of products for in-center disposables, acute care treatments and machines for chronic treatment.
Operating income
Operating income decreased by 1% (-2% at Constant Exchange Rates), primarily due to inflationary cost increases and higher bad debt expense, partially offset by favorable foreign currency transaction effects and business growth in certain business lines.
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FRESENIUS MEDICAL CARE AG & Co.