Akebia Therapeutics Announces Amendment of License Agreement with Vifor Pharma in Preparation for Potential Vadadustat Launch

On February 22, 2022 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, and Vifor Pharma Group (Vifor Pharma), reported that the companies have amended and restated the terms of their license agreement, pursuant to which Akebia Therapeutics, Inc. (Akebia) granted Vifor Pharma an exclusive license to sell vadadustat, Akebia’s investigational oral therapeutic for the treatment of anemia due to chronic kidney disease (CKD), to Fresenius Medical Care North America and its affiliates (including Fresenius Kidney Care Group LLC) and other entities in the United States, subject to vadadustat’s approval by the U.S. Food and Drug Administration (FDA) (Press release, Akebia, FEB 22, 2022, View Source [SID1234608790]). Vadadustat’s Prescription Drug User Fee Act (PDUFA) date is March 29, 2022.

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The new agreement further supports Akebia’s commercialization strategy ahead of a potential first-in-class U.S. launch for vadadustat which, as previously noted, provides access to up to 60% of U.S. dialysis patients through existing Vifor Pharma relationships. Previous agreements between the companies granted Vifor Pharma an exclusive license to sell vadadustat, if approved by the FDA, to Fresenius Kidney Care Group for use solely within its dialysis facilities and certain other third-party dialysis facilities in the U.S. The new agreement further expands this license to also include additional independent dialysis organizations.

"Vifor Pharma shares our commitment to bring innovative treatments to people living with kidney disease, which has been a cornerstone of our longstanding relationship," said John P. Butler, Chief Executive Officer of Akebia. "As we approach vadadustat’s PDUFA date and potential launch, we are thrilled to clarify the agreement, which we believe will enable our companies to get vadadustat to dialysis patients more quickly."

In consideration for the extension of Vifor Pharma’s customer group, Vifor Pharma agreed to an additional equity purchase of $20 million. Further, Vifor Pharma will contribute $40 million for use as working capital to partially fund Akebia’s costs of manufacturing vadadustat to support commercialization in the U.S. following FDA approval; such working capital to be refundable over time.

Under the terms of the amended and restated agreement, Vifor Pharma will accelerate payment of the previously agreed upon $25 million milestone to Akebia. Akebia will retain approximately 66% of the profit, net of certain pre-specified costs. Akebia will share the profit with Otsuka pursuant to the License and Collaboration Agreement between Akebia and Otsuka in the U.S.

Akebia has retained all rights to commercialize vadadustat, in collaboration with Otsuka, in the non-dialysis dependent market and to the remaining dialysis organizations representing approximately 40% of the U.S. dialysis market, following FDA approval.

Fresenius Medical Care delivers on 2021 guidance, targets return to earnings growth in 2022

On February 22, 2022 Fresenius Medical Care, reported Throughout 2021, COVID-19 has significantly impacted our patients’ and employees’ lives as well as Fresenius Medical Care as a company (Press release, Fresenius, FEB 22, 2022, View Source [SID1234608787]). Although excess mortality among our patients in the fourth quarter has moderated, the accumulated impact of COVID-19 weighed heavier on our earnings development than we had anticipated in the beginning of 2021. Given these challenging headwinds, we are proud that we have continuously been there for our patients and, on the back of this, were able to deliver on our 2021 guidance. Despite the ongoing impact of the pandemic and an increasingly inflationary cost environment, we target to return to earnings growth this year. At the same time, we will continue to execute on the key priorities of our Strategy 2025, advancing on our transformational FME25 program as well as progressing on our Sustainability agenda."

1 2021: costs related to the FME25 program; 2020: impairment of goodwill and trade names in the Latin America Segment
2 Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA

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Implementing strategic priorities

Based on its Strategy 2025, Fresenius Medical Care aims to capture further growth potential along the Renal Care Continuum and beyond – by leveraging its core competencies and offering sustainable solutions with innovative products and services of the highest quality and at reliable costs. To this end, the company is continuing to steadily drive forward its strategic priorities.
Fresenius Medical Care aims to build sustainable partnerships with payors worldwide to support the transition from a fee-for-service to a pay-for-performance system. In Value-based Care models, the Company contributes to creating medical value while ensuring that care remains affordable.

Fresenius Medical Care´s longstanding experience in Value-based Care and the largest database of CKD (Chronic Kidney Disease) patients in the industry enables the use of proprietary predictive models to slow kidney disease progression and reduce hospital admissions. In 2022, the Company expects to grow the number of its ESRD (End-Stage Renal Disease) and CKD patients receiving care in Value-based Care arrangements from more than 20,0000 patients at the end of 2021 to around 80,000. The significant increase compared to the previous year will be mainly driven by the start on 1 January 2022 of the Comprehensive Kidney Care Contracting options (CKCC) of the Centers for Medicare and Medicaid Services (CMS) in the U.S. Across all Value-based Care arrangements, Fresenius Medical Care expects to be managing risk for more than USD 6 billion in medical expenses in 2022.

To further enhance the quality of life for its patients and increase their choice of available treatment options, Fresenius Medical Care remains committed to further expanding its home dialysis offerings. In 2021, the Company provided around 15% of its dialysis treatments in the U.S. in a home setting and has thus already achieved its target originally set for 2022.
Based on its strategic business planning, Fresenius Medical Care has set a new aspirational target for the expansion of home dialysis: By 2025, the Company aims to perform 25% of all treatments in the U.S. at a patient’s home.

Fresenius Medical Care’s commitment to Sustainability is not only incorporated in its vision and mission but also reflected in its strategy. To shape operations, integrate sustainability principles into business activities and assume even greater accountability, the Company is consistently advancing its global sustainability activities. In 2021, Fresenius Medical Care reached further important milestones in focus areas such as patients and employees, environmental protection, combating bribery and corruption, and respect for human rights. More than ever, Fresenius Medical Care continues to actively drive progress of its Sustainability agenda.

As part of the FME25 program, Fresenius Medical Care is transforming its operating model into a simplified structure with two global operating segments – Care Enablement and Care Delivery, thus providing the basis for the acceleration of innovation for our patients and future sustainable profitable growth.

Helen Giza, Chief Financial Officer and Chief Transformation Officer of Fresenius Medical Care, said: "We continue to move at pace on the overall implementation and execution of our transformation program, focusing on unlocking shareholder value, creating the basis for future sustainable profitable growth and shaping the organization to the new operating model. An important step in that direction was the recent naming of the next level of leaders in the new organization."

The Company is committed to implementing necessary changes in a socially responsible way, and to following applicable consultation procedures with works councils and other workplace representative bodies in good faith.

Fresenius Medical Care expects to implement its new global operating model around 2023 and the savings initiative to be largely completed by 2024. With the transformation of the operating model, the annual cost base shall be reduced by EUR 500 million by the end of 2025. One-time costs of FME25 are expected to amount to approximately EUR 450-500 million. In 2021, costs incurred for FME25 amounted to EUR 63 million in the program.

For 2022, the Company expects FME25-related one-time costs of approximately EUR 175 to 245 million and has included EUR 40 to 70 million of sustainable EBIT savings in its outlook.

Decrease in COVID-19-related excess mortality

Despite the global spread of the Omicron variant, which resulted in a significant increase in infection rates in many countries, COVID-19-related excess mortality among Fresenius Medical Care’s patients decreased in the fourth quarter of 2021 and amounted to around 1,800 (Q1 2021: ~3,200; Q2 2021: ~1,900; Q3 2021: ~2,9003). Thus, excess mortality accumulated to approximately 9,800 patients in FY 2021 and approximately 20,100 since the start of the pandemic.

The overall estimated adverse effect of accumulated COVID-19-related excess mortality on organic growth in the Health Care Services business amounted to around 290 basis points in the fourth quarter and 280 basis points in the full year 2021.

As of year-end 2021, approximately 81% (U.S.: ~80%) of Fresenius Medical Care’s patients had been at least partially vaccinated; 58% (U.S.: ~57%) of all fully vaccinated patients had already received a booster vaccination.

3 Historical excess mortality updated for late entries

Revenue and earnings development affected by COVID-19

Revenue in the fourth quarter increased by 6% to EUR 4,647 million (+3% at constant currency, +2% organic).

Health Care Services revenue increased by 6% to EUR 3,621 million (+3% at constant currency, +2% organic). This was mainly driven by a positive exchange rate effect as well as organic growth, which was achieved despite the adverse impact of COVID-19 and a lower reimbursement for calcimimetics.

Health Care Products revenue increased by 3% to EUR 1,026 million (+1% at constant currency, +1% organic), mainly driven by a positive exchange rate effect as well as higher sales of machines for chronic treatment, home hemodialysis products and in-center disposables, partially offset by lower sales of products for acute care treatments.

In the full year, revenue declined by 1% to EUR 17,619 million (+2% at constant currency, +1% organic). Health Care Services revenue decreased by 2% to EUR 13,876 million (+2% at constant currency, +1% organic), mainly due to a negative exchange rate effect, partially offset by organic growth, which was achieved despite COVID-19 and a lower reimbursement for calcimimetics, as well as higher contributions from acquisitions. Health Care Products revenue remained stable and amounted to EUR 3,743 million (+2% at constant currency, +2% organic). Higher sales of machines for chronic treatment, home hemodialysis products and renal pharmaceuticals were offset by a negative exchange rate effect and lower sales of products for acute care treatments.

Operating income decreased by 3% to EUR 449 million in the fourth quarter (-7% at constant currency), resulting in a margin of 9.7% (Q4 2020: 10.5%). Operating income excluding special items, i.e. the impairment of goodwill and trade names in the Latin America Segment in 2020 and costs incurred for FME25 in 2021, declined by 25% to EUR 492 million (-28% at constant currency), resulting in a margin of 10.6% (Q4 2020: 14.9%). The decline was mainly due to a remeasurement effect on the fair value of investments, higher labor costs, the adverse COVID-19-related net effects and inflationary materials cost increases. These effects were only slightly mitigated by an improved U.S. payor mix, in particular due to an increased number of patients with Medicare Advantage coverage.

In the full year, operating income decreased by 20% to EUR 1,852 million (-17% at constant currency), resulting in a margin of 10.5% (FY 2020: 12.9%). Operating income excluding special items declined by 23% to EUR 1,915 million (-21% at constant currency), resulting in a margin of 10.9% (FY 2020: 14.0%). This was mainly due to adverse COVID-19-related net effects, inflationary materials cost increases, higher labor costs, and the remeasurement effect on the fair value of investments. These effects were slightly mitigated by an improved U.S. payor mix, in particular due to an increased number of patients with Medicare Advantage coverage.

Net income2 increased by 29% to EUR 229 million in the fourth quarter (+23% at constant currency). Excluding special items, net income declined by 29% to EUR 263 million (-32% at constant currency), mainly due to the mentioned negative effects on operating income.

In the full year, net income decreased by 17% to EUR 969 million (-14% at constant currency). Net income excluding special items declined by 25% to EUR 1,018 million (-23% at constant currency).

Basic earnings per share (EPS) increased by 29% to EUR 0.78 (+23% at constant currency) in the fourth quarter. EPS excluding special items declined by 29% to EUR 0.90 (-32% at constant currency).

In the full year, EPS decreased by 16% to EUR 3.31 (-14% at constant currency). EPS excluding special items declined by 25% to EUR 3.48 (-23% at constant currency).

Cash flow development

In the fourth quarter, Fresenius Medical Care generated EUR 669 million of operating cash flow (Q4 2020: EUR 584 million), resulting in a margin of 14.4% (Q4 2020: 13.3%). The increase was mainly due to improved working capital including contributions from FME25 and U.S. federal relief funding, partially offset by continued recoupment of the U.S. government’s payments received in 2020 under the CARES Act and lower tax payments related to COVID-19 reliefs in the prior year. In the full year, operating cash flow amounted to EUR 2,489 million (FY 2020: EUR 4,233 million), resulting in a margin of 14.1% (FY 2020: 23.7%). The decline was mainly due to the U.S. government’s advanced payments received in 2020, the partial recoupment of these payments in 2021 as well as other COVID-19 relief, including lower tax payments in North America segment in the previous year.

Fresenius Medical Care generated EUR 400 million of free cash flow4 (Q4 2020: EUR 283 million) in the fourth quarter, resulting in a margin of 8.6% (Q4 2020: 6.4%). In the full year, free cash flow amounted to EUR 1,660 million (FY 2020: EUR 3,197 million), resulting in a margin of 9.4% (FY 2020: 17.9%).

4 Net cash provided by / used in operating activities, after capital expenditures, before acquisitions, investments, and dividends

Regional developments

In North America, revenue increased by 6% to EUR 3,156 million in the fourth quarter (+1% at constant currency, 0% organic). A positive exchange rate effect was largely offset by the adverse COVID-19 impact on both the Health Care Services and Health Care Products businesses along with associated downstream effects. In the full year, revenue decreased by 3% to EUR 12,088 million (stable at constant currency, 0% organic).

Operating income in North America decreased by 25% to EUR 402 million in the fourth quarter (-29% at constant currency), resulting in a margin of 12.7% (Q4 2020: 17.9%). The decline was mainly due to a remeasurement effect on the fair value of investments, higher personnel expense, the adverse net impact of COVID-19 and costs related to FME25. This was only partially offset by an improved U.S. payor mix, in particular due to an increased number of patients with Medicare Advantage coverage. In the full year, operating income declined by 22% to EUR 1,644 million (-20% at constant currency), resulting in a margin of 13.6% (FY 2020: 17.0%).

Revenue in the EMEA region increased by 2% to EUR 732 million in the fourth quarter (+2% at constant currency, +2% organic), mainly driven by organic growth in the Health Care Services business, which was achieved despite the negative impact of COVID-19. In the full year, revenue remained stable and amounted to EUR 2,765 million (+1% at constant currency, +1% organic).
Operating income in EMEA decreased by 42% to EUR 77 million in the fourth quarter (-42% at constant currency), resulting in a margin of 10.6% (Q4 2020: 18.7%). The decline was mainly due to a favorable impact from equity method investees in the previous year, inflationary cost increases, adverse COVID-19-related effects and costs related to FME25. In the full year, operating income decreased by 25% to EUR 309 million (-25% at constant currency), resulting in a margin of 11.2% (FY 2020: 14.9%).

In Asia-Pacific, revenue increased by 7% to EUR 552 million in the fourth quarter (+5% at constant currency, +4% organic). This was mainly driven by organic growth in both the Health Care Services and Health Care Products business as well as a positive exchange rate effect. In the full year, revenue grew by 6% to EUR 2,010 million (+7% at constant currency, +7% organic), thus exceeding EUR 2 billion for the first time.

Operating income decreased by 12% to EUR 94 million in the fourth quarter (-12% at constant currency), resulting in a margin of 17.0% (Q4 2020: 20.6%). The decline was mainly due to inflationary cost increases and adverse COVID-19-related effects. In the full year, operating income grew by 2% to EUR 350 million (+3% at constant currency), resulting in a margin of 17.4% (FY 2020: 18.1%).

Despite a significant headwind from exchange rates and the adverse impact of COVID-19, Latin America revenue increased by 10% to EUR 195 million in the fourth quarter (+17% at constant currency, +20% organic). This was mainly driven by strong organic growth in both the Healthcare Services and Healthcare Products business. In the full year, revenue grew by 3% to EUR 703 million (+16% at constant currency, +15% organic).

Due to the impairment of goodwill and trade names in the Latin America Segment that impacted earnings in the previous year, operating income for the region improved by 99% to EUR -2 million in the fourth quarter (+99% at constant currency), resulting in a margin of -0.8% (Q4 2020: -105.0%). In the full year, operating income increased to EUR 12 million, resulting in a margin of 1.7%.

Patients, clinics and employees

As of December 31, 2021, Fresenius Medical Care treated 345,425 patients in 4,171 dialysis clinics worldwide. At the end of 2021, the Company had 122,909 employees (full-time equivalents) worldwide, compared to 125,364 employees as of December 31, 2020.

25th consecutive dividend increase to be proposed

Consistent with Fresenius Medical Care’s commitment to drive shareholder returns while striving for dividend continuity, the Company proposes a dividend of EUR 1.35 per share to the Annual General Meeting in May 2022. This proposal would result in the 25th consecutive dividend increase. The Company believes that the fundamental drivers of its business and growth remain unchanged, despite the unprecedented but temporary effects of the COVID-19 pandemic.

Outlook

Fresenius Medical Care expects revenue and net income to grow at low to mid-single digit percentage rates in FY 2022.5
These targets are based on the following assumptions:

COVID-19
accumulated excess mortality to impact operating income by EUR 100 million compared to the level of 2021
staff shortages are anticipated not to cause significant disruptions in production, distribution and dialysis operations
Macro-economic inflation and supply chain costs to impact operating income by EUR 50 million
Labor costs for 2022 are expected to be around EUR 100 million in excess of the 3% base wage inflation assumption
Any potential further government support is assumed to be applied to manage the unprecedented labor market situation if costs exceed the above labor costs assumption.
FME25 savings are expected to contribute EUR 40 to 70 million to operating income
Remeasurement effects on the fair value of investments are expected to be volatile but neutral on a full year basis
Based on current projections, Fresenius Medical Care confirms its mid-term targets that are based on the Company’s mid-term strategy. Until 2025 the Company expects compounded annual average increases in the mid-single-digit percentage range for revenue and in the high-single-digit percentage range for net income.6 Fresenius Medical Care expects FME25 savings to mitigate the ongoing negative effects of COVID-19.

5 These targets are based on the 2021 results excluding the costs related to FME25 of EUR 49 million (for Net Income). They are based on the outlined assumptions, in constant currency and exclude special items. Special items include further costs related to FME25 and other effects that are unusual in nature and have not been foreseeable or not foreseeable in size or impact at the time of giving guidance.

6 These targets are in constant currency and exclude special items.

Press conference

Fresenius Medical Care will hold a virtual press conference to discuss the results of the fourth quarter and full year 2021 on February 22, 2022 at 10:00 a.m. CET / 4:00 a.m. ET. The press conference will be webcasted on the Company’s website www.freseniusmedicalcare.com in the "Media" section. A replay will be available shortly after the conference.

Conference call

Fresenius Medical Care will host a conference call to discuss the results of the fourth quarter and full year 2021 on February 22, 2022 at 3:30 p.m. CET / 9:30 a.m. ET. Details will be available on the Fresenius Medical Care website www.freseniusmedicalcare.com in the "Investors" section. A replay will be available shortly after the call.

Please refer to our statement of earnings included at the end of this news and to the attachments as separate PDF files for a complete overview of the results of the fourth quarter and full year 2021. Our 20-F disclosure provides more details.

ChromaDex to Report Fourth Quarter 2021 Financial Results on Wednesday, March 9, 2022

On February 22, 2022 ChromaDex Corp. (NASDAQ:CDXC) reported that it will hold a conference call on Wed. March 9, 2022 at 4:30 p.m. ET to discuss its financial results for the fourth quarter ended December 31, 2021 (Press release, ChromaDex, FEB 22, 2022, View Source [SID1234608785]). The financial results will be reported in a press release after the close of regular stock market trading hours on the same day as the conference call.

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Investor Conference Call:

ChromaDex management will host an investor conference call to discuss the fourth quarter results and provide a general business update on Wed., March 9, at 4:30 p.m. ET.

Participants should call in at least 10 minutes prior to the call. The dial-in information is as follows:

Webcast link: ChromaDex Fourth Quarter 2021 Earnings Conference Call

The conference call will be broadcast live and available for replay here and via the investor relations section of the Company’s website at www.chromadex.com.

A replay of the conference call will be available from 7:30 p.m. ET on March 9, 2022, to 11:59 p.m. ET on March 16, 2022.

Myricx Pharma Announces Senior Team Expansion with Appointment of CMO, and Heads of Biology and Bioinformatics

On February 22, 2022 Myricx Pharma (‘Myricx’), a drug discovery company focused on developing small molecule inhibitors that selectively target the human N-myristoyltransferases (NMT) in cancer, reported expansion of its senior team with the appointments of Zahid Bashir as Chief Medical Office (CMO), Richard Rutter as Head of Biology and Francesco Falciani as Head of Bioinformatics (Press release, Myricx Pharma, FEB 22, 2022, View Source [SID1234608367]).

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With an initial focus in multiple oncology indications Myricx is developing a pipeline of novel proprietary inhibitors of human N-myristoyltransferases (NMT). The new appointments reflect the Company’s progress as it advances its lead programmes through preclinical development and IND-enabling studies.

Zahid Bashir, MB BS, MSc is a highly experienced clinical development consultant in the fields of oncology and haematology. He brings over 15 years’ clinical and drug development experience to Myricx. Recognised for his success in planning, leading and executing clinical and drug development programmes for pharma and biotech companies, his relevant responsibilities include Roche, GSK, Kite Pharma, BMS and AstraZeneca. He has gained extensive experience throughout all phases of clinical development and successfully brought multiple novel drugs including cell and gene therapy products to cancer patients. Full bio HERE.

Richard Rutter, PhD is an experienced pharmacologist and drug discovery biologist with over 20 years in the pharma and biotech industries. He was a Director of Biology at the GlaxoSmithKline Neurodegeneration Research Unit in Singapore and a member of the R&D leadership team managing a portfolio of preclinical programs from early target identification through to candidate nomination. He has also held the role of CSO at Auspherix Ltd and is a co-founder of NRG Therapeutics. Full bio HERE.

Francesco Falciani, PhD is a specialist in developing novel computational approaches in systems biology and the application of these techniques to complex biological systems. He has over 30 years of experience working in both academia and industry. He holds an Honorary Professorship in integrative Systems Biology at the University of Liverpool where until 2021 he served as a Director of the University’s Computational Biology facility. Before establishing his career in academia, Francesco worked at GlaxoWellcome as Bioinformatics Group Leader and was Head of Target Discovery at Lorantis Ltd. Full bio HERE.

Welcoming the new senior team members to the company Roberto Solari, PhD, Chairman, Chief Executive Officer and Co-founder said:

"We are delighted to welcome Zahid, Richard and Francesco to the Myricx leadership team. As we progress our novel NMT inhibitors towards IND enabling studies and expand our proprietary pipeline of targeted cancer therapies for precision medicine their collective skills and experiences will be invaluable in strengthening our clinical development, biology and bioinformatics capabilities."

Myricx is a start-up from two of the UK’s leading biomedical research organisations and is pursuing NMT inhibition in a variety of indications with an initial focus in oncology. The Company is exploiting novel breakthrough discoveries that are backed up with very high. quality chemistry. Myricx identified that inhibition of NMT results in specific cancer cell killing via an unexpected and unique mechanism. The Company has discovered that its NMT inhibitors are proving to be highly effective in the treatment of MYC-driven cancer models.

Fresenius delivers a strong finish to the year meeting its improved 2021 guidance – Strategic evaluation shows path to accelerated growth

On February 22, 2022 Fresenius, reported that our mission is to protect people’s health (Press release, Fresenius, FEB 22, 2022, View Source [SID1234608366]). Fulfilling that mission has rarely been as difficult as during this pandemic. But we have done our part and have lived up to our responsibility. In business terms, too, 2021 was challenging yet successful: We delivered a strong final quarter and fully met our targets for the year. In 2022 we expect continued profitable growth, despite rising inflation and the ongoing burdens caused by the pandemic. In our cost and efficiency program, we have made faster than expected progress. This is an important factor enabling us to confirm the medium-term targets we set well before the pandemic, giving us all the more reason to look ahead with optimism."

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Path to accelerated growth
Fresenius has defined a strategic path to pursue accelerated profitable growth and hence to sustainably strengthen the Group and each of its business segments by tapping new sources of capital and prioritizing segment capital allocation. All our stakeholders continue to benefit from the advantages of the Group’s current structure, which offers stability through diversification as well as efficiency through economies of scale, access to attractive debt financing and tax savings.

All of Fresenius’ business segments have excellent market positions and ample meaningful growth opportunities. Properly balancing the objectives of all our stakeholder groups requires an even more targeted approach to capital allocation. While Fresenius continues to believe in the virtues of vertical integration, the Company is keen to gradually re-balance the relative weights of its products and service businesses.

Primarily based on its superior profitability and excellent growth prospects, Fresenius Kabi is defined as top priority. With respect to Fresenius Medical Care, which has been particularly hard hit by the pandemic, the transformation program FME25 is expected to result in ever improving profitability and accelerated growth, driving improved valuation for Fresenius’ controlling stake. For Fresenius Helios and Fresenius Vamed, smaller inorganic growth opportunities will continue to be financed from Fresenius Group funds. For larger growth opportunities, Fresenius is open to value-enhancing external equity investments at the level of these business segments. An equity increase on Group level would then be redundant and is hence not foreseen.

By setting this course, Fresenius will accelerate the growth of each of our business segments for the benefit of all stakeholders.

"We are moving Fresenius ahead at speed, with a measured and well-managed transformation of our company. All our business segments have strong market positions, and great growth potential. We intend to harness this potential – guided by clear strategic priorities that will combine additional sources of more dynamic growth with the advantages of a broad business structure. Fresenius remains a diversified healthcare group, with a sharper profile, that will be active in wide-ranging and very exciting areas of medicine," said Stephan Sturm, CEO of Fresenius.

FY/22 Group guidance
For FY/22, Fresenius projects sales growth1 in a mid-single-digit percentage range in constant currency. Net income2,3 is expected to grow in a low-single-digit percentage range in constant currency. Implicitly, net income2 for the Group excluding Fresenius Medical Care is expected to grow in a low-single-digit percentage range in constant currency.
Without further acquisitions, Fresenius projects an improvement of the net debt/EBITDA4 ratio (December 31, 2021: 3.51×5) into the self-imposed target corridor of 3.0x to 3.5x by the end of 2022.

Assumptions for guidance FY/22
COVID-19 will continue to impact Fresenius’ operations in 2022. The extent of the impact on the Group is to a large degree dependent on the vaccination coverage in Fresenius’ relevant markets and the potential evolution of new virus mutants.

Fresenius closely monitors the development of the COVID-19 pandemic and the associated various containment measures enacted in the Company’s relevant markets. Fresenius expects COVID-19 case numbers to decline from spring 2022 onwards and consequently the number of elective treatments and staff availability to improve. A possible significant deterioration of the situation associated with further containment measures that could have a significant and direct impact on the health care sector without any appropriate compensation is not reflected in the Group’s FY/22 guidance.

1 FY/21 base: €37,520 million
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
3 FY/21 base: €1,867 million; before special items; FY/22: before special items
4 At LTM average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures; excluding further potential acquisitions; before special items; including lease liabilities
5 At LTM average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures; before special items; including lease liabilities

For a detailed overview of special items please see the reconciliation tables on pages 21-25 in the PDF.

Headwinds from cost inflation are reflected. However, Fresenius expects no significant acceleration of inflation effects and supply chain challenges versus the current environment. The Management Board assumes an unchanged corporate tax rate in the United States.

Furthermore, the assumptions for Fresenius Medical Care’s FY/22 guidance are also fully applicable to Fresenius Group’s FY/22 guidance.

All of these assumptions are subject to considerable uncertainty.

Cost and efficiency program leading to significantly higher savings
Fresenius has successfully completed the first phase of its cost and efficiency program aiming to further safeguard the Group’s medium-term targets and to sustainably enhance profitability. This has led to initial cost savings of ~€20 million and one-time expenses of ~€80 million in 2021. Given the good progress, especially driven by the accelerated implementation of initiatives, Fresenius significantly increases its savings target and now expects cost savings of at least €150 million p.a. after tax and minority interest in 2023. Initially, more than €100 million p.a. after tax and minority interest were projected. For the years thereafter, a further significant increase in sustainable cost savings is expected. The savings will be achieved by all four business segments and the corporate center.

Fresenius anticipates that achieving these sustainable efficiency improvements will require up-front expenses of more than €200 million in 2022 and further expenses of around €100 million in 2023, in each case after taxes and minority interest. No further significant expenses are expected thereafter. In line with previous practice, these expenses are classified as special items.

Growth targets for 2020 – 2023 confirmed and specified
Based on the anticipated positive contributions from the cost and efficiency program as well as the attractive growth opportunities across all business segments, Fresenius expects Group earnings growth to meaningfully accelerate until 2023. The company hence confirms its medium-term targets set in 2019 despite the ongoing challenges posed by COVID-19. At the same time, Fresenius specifies its expectations and now anticipates Group organic sales growth to reach the bottom to middle of the targeted 4% to 7% compounded annual growth rate (CAGR) and Group organic net income1,2 growth to be at the bottom end of the 5% to 9% CAGR during 2020 to 2023. Due to the COVID-19 pandemic, Fresenius now expects small and medium-sized acquisitions to contribute an incremental CAGR of less than 1% to both sales and net income growth.

29th consecutive dividend increase proposed
Consistent with Fresenius’ stated policy, the Management Board of Fresenius will propose to the Supervisory Board a dividend increase of 5% to €0.92 per share for FY/21 (FY/20: €0.88). Provided the proposal is approved by the Supervisory Board and the Annual General Meeting, this will be the 29th consecutive dividend increase.

The Management Board will propose a scrip dividend to the Supervisory Board, thereby giving shareholders the option to receive their dividend (except for the tax portion of the dividend) in the form of new Fresenius shares. The Else Kröner-Fresenius-Foundation has informed Fresenius that it intends to fully participate in the scrip dividend.

Fresenius to be climate neutral by 2040
Fresenius has set a climate target for the Group complementing its existing sustainability targets and programs. The company aims to be climate neutral by 2040 and to reduce 50% of absolute scope 1 and scope 2 emissions by 2030 compared to 2020 levels. Fresenius will continuously assess scope 3 emission impacts for inclusion in targets. Further information at View Source and in today’s separate press release at View Source

1 Net income attributable to shareholders of Fresenius SE & Co. KGaA
2 Before special items

For a detailed overview of special items please see the reconciliation tables on pages 21-25 in the PDF.

5% sales growth in constant currency
Group sales increased by 7% (5% in constant currency) to €9,966 million (Q4/20: €9,304 million). Organic growth was 4%. Acquisitions/divestitures contributed net 1% to sales growth. Currency translation increased sales growth by 2%. Excluding estimated COVID-19 effects1, Group sales growth would have been 5% to 6% in constant currency.

In FY/21, Group sales increased by 3% (5% in constant currency) to €37,520 million (FY/20: €36,277 million). Organic growth was 4%. Acquisitions/divestitures contributed net 1% to sales growth. Currency translation reduced sales growth by 2%. Excluding estimated COVID-19 effects1, Group sales growth would have been 5% to 6% in constant currency.

5% net income2,3 growth in constant currency
Group EBITDA before special items decreased by 2% (-5% in constant currency) to €1,846 million (Q4/202: €1,886 million). Reported Group EBITDA was €1,868 million (Q4/20: €1,854 million).

In FY/21, Group EBITDA before special items decreased by 4% (-2% in constant currency) to €6,854 million (FY/202: €7,132 million). Reported Group EBITDA was €6,825 million (FY/20: €7,100 million).

Group EBIT before special items decreased by 7% (-9% in constant currency) to €1,166 million (Q4/202: €1,251 million). The decrease is primarily due to COVID-19 related headwinds at Fresenius Medical Care. The EBIT margin before special items was 11.7% (Q4/202: 13.4%). Reported Group EBIT was €1,123 million (Q4/20: €1,024 million).

In FY/21, Group EBIT before special items decreased by 8% (-6% in constant currency) to €4,252 million (FY/202: €4,612 million). The decrease is primarily due to COVID-19 related headwinds at Fresenius Medical Care. The EBIT margin before special items was 11.3% (FY/202: 12.7%). Reported Group EBIT was €4,158 million (FY/20: €4,385 million).

1 For estimated COVID-19 effects in Q4/21 and FY/21 please see table on page 19 in the PDF.
2 Before special items
3 Net income attributable to shareholders of Fresenius SE & Co. KGaA

For a detailed overview of special items please see the reconciliation tables on pages 21-25 in the PDF.

Group net interest before special items improved to -€120 million (Q4/202: -€159 million) mainly due to successful refinancing activities. Reported Group net interest improved to -€122 million (Q4/20: -€156 million).

In FY/21, Group net interest before special items improved to -€504 million (FY/201: – €654 million) while reported Group net interest improved to -€506 million (FY/20: -€659 million).

The Group tax rate before special items was 23.1% (Q4/201: 24.1%) while the reported Group tax rate was 24.2% (Q4/20: 29.4%). In FY/21, the Group tax rate before special items was 22.6% (FY/201: 23.1%) while the reported Group tax rate was 22.8% (FY/20: 24.2%).

Noncontrolling interests before special items were €283 million (Q4/201: €335 million) of which 90% were attributable to the noncontrolling interests in Fresenius Medical Care. Reported noncontrolling interests were €260 million (Q4/20 reported: €203 million).

In FY/21, noncontrolling interests before special items were €1,033 million (FY/201: €1,248 million) of which 91% were attributable to the noncontrolling interests in Fresenius Medical Care. Reported noncontrolling interests were €1,001 million (FY/20 reported: €1,116 million).

Group net income2 before special items increased by 5% (3% in constant currency) to €521 million (Q4/201: €494 million). The increase is driven by the strong development of Fresenius Kabi’s Emerging Market business, a good performance at Helios Germany, an excellent finish to the year by Fresenius Vamed and the favorable net interest development. Excluding estimated COVID-19 effects3, Group net income2 before special items would have grown 3% to 7% in constant currency. Reported Group net income2 increased to €499 million (Q4/20: €410 million).

In FY/21, Group net income2 before special items increased by 4% (5% in constant currency) to €1,867 million (FY/201: €1,796 million). Excluding estimated COVID-19 effects3, Group net income2 before special items would have grown 6% to 10% in constant currency. Reported Group net income2 increased to €1,818 million (FY/20: €1,707 million).

1 Before special items
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
3 For estimated COVID-19 effects in Q4/21 and FY/21 please see table on page 19 in the PDF.

For a detailed overview of special items please see the reconciliation tables on pages 21-25 in the PDF.

Earnings per share1 before special items increased by 5% (2% in constant currency) to €0.94 (Q4/202: €0.88). Reported earnings per share1 were €0.90 (Q4/20: €0.73). In FY/21, earnings per share1 before special items increased by 4% (5% in constant currency) to €3.35 (FY/202: €3.22). Reported earnings per share1 were €3.26 (FY/20: €3.06).

Continued investment in growth
Spending on property, plant and equipment was €690 million corresponding to 7% of sales (Q4/20: €856 million; 9% of sales). These investments served primarily for the modernization and expansion of dialysis clinics, production facilities as well as hospitals and day clinics. In FY/21, spending on property, plant and equipment was €2,032 million corresponding to 5% of sales (FY/20: €2,398 million; 7% of sales).

Total acquisition spending was €278 million (Q4/20: €251 million). In FY/21, total acquisition spending was €1,085 million (FY/20: €902 million) mainly for the acquisition of the Eugin Group at Fresenius Helios which has been consolidated since April 1, 2021, and the acquisition of dialysis clinics at Fresenius Medical Care.

Strong cash flow development in Q4/21
Group operating cash flow increased by 26% to €1,749 million (Q4/20: €1,390 million) with an improved margin of 17.5% (Q4/20: 14.9%) mainly due to stringent working capital management. The good operating performance at Helios Spain, Fresenius Vamed and Fresenius Kabi also contributed to the positive development. Free cash flow before acquisitions and dividends increased to €1,075 million (Q4/20: €590 million). Free cash flow after acquisitions and dividends increased to €841 million (Q4/20: €329 million).

In FY/21, Group operating cash flow decreased to €5,078 million (FY/20: €6,549 million) with a margin of 13.5% (FY/20: 18.1%) mainly due to the U.S. government’s advanced payments received in 2020 and the partial recoupment of these payments in 2021 at Fresenius Medical Care.

Free cash flow before acquisitions and dividends decreased to €3,061 million (FY/20: €4,183 million). Free cash flow after acquisitions and dividends decreased to €1,193 million (FY/20: €2,478 million).

1 Net income attributable to shareholders of Fresenius SE & Co. KGaA
2 Before special items

For a detailed overview of special items please see the reconciliation tables on pages 21-25 in the PDF.

Solid balance sheet structure
Group total assets increased by 8% (4% in constant currency) to €71,962 million (Dec. 31, 2020: €66,646 million). The increase is mainly due to currency translation effects, acquisitions as well as the expansion of business activities. Current assets increased by 11% (8% in constant currency) to €17,461 million (Dec. 31, 2020: €15,772 million) driven by the increase of cash and cash equivalents, trade accounts receivables and inventories. Non-current assets increased by 7% (3% in constant currency) to €54,501 million (Dec. 31, 2020: €50,874 million).

Total shareholders’ equity increased by 13% (7% in constant currency) to €29,288 million (Dec. 31, 2020: €26,023 million). The increase is due to currency translation effects as well as the good net income development. The equity ratio was 40.7% (Dec. 31, 2020: 39.0%).

Group debt increased by 5% (2% in constant currency) to €27,155 million (Dec. 31, 2020: € 25,913 million). Group net debt increased by 1% (-1% in constant currency) to € 24,391 million (Dec. 31, 2020: € 24,076 million).

As of December 31, 2021, the net debt/EBITDA ratio increased to 3.51×1,2 (Dec. 31, 2020: 3.44×1,2) driven by COVID-19 effects weighing on EBITDA.

1 At LTM average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures; including lease liabilities
2 Before special items

For a detailed overview of special items please see the reconciliation tables on pages 21-25 in the PDF.

Business Segments

Fresenius Medical Care (Financial data according to Fresenius Medical Care press release)
Fresenius Medical Care is the world’s largest provider of products and services for individuals with renal diseases. As of December 31, 2021, Fresenius Medical Care was treating 345,425 patients in 4,171 dialysis clinics. Along with its core business, the Renal Care Continuum, the company focuses on expanding in complementary areas and in the field of critical care.

• Business development significantly impacted by COVID-19 in 2021, effects are expected to continue into 2022
• Decline in excess mortality in the fourth quarter
• Return to earnings growth in 2022 targeted

Sales increased by 6% (3% in constant currency) to €4,647 million (Q4/20: €4,400 million). Currency translation increased sales growth by 3%. Organic growth was 2%. Acquisitions/divestitures contributed net 1% to sales growth.

In FY/21, sales decreased by 1% (increased by 2% in constant currency) to €17,619 million (FY/20: €17,859 million). Currency translation decreased sales growth by 3%. Organic growth was 1%. Acquisitions/divestitures contributed net 1% to sales growth.

EBIT decreased by 3% (-7% in constant currency) to €449 million (Q4/20: €462 million) resulting in a margin of 9.7% (Q4/20: 10.5%). EBIT before special items decreased by 25% (-28% in constant currency) to €492 million (Q4/20: €657 million), resulting in a margin of 10.6% (Q4/20: 14.9%). The decline was mainly due to a remeasurement effect on the fair value of investments, higher labor cost, the adverse COVID-19-related net effects and inflationary materials cost increases. These effects were only slightly mitigated by an improved U.S. payor mix, in particular due to an increased number of patients with Medicare Advantage coverage.

1 Before special items
2 Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA

For a detailed overview of special items please see the reconciliation tables on pages 21-25 in the PDF.

In FY/21, EBIT decreased by 20% (-17% in constant currency) to €1,852 million (FY/20: €2,304 million) resulting in a margin of 10.5% (FY/20: 12.9%). EBIT before special items decreased by 23% (-21% in constant currency) to €1,915 million (FY/20: €2,499 million), resulting in a margin of 10.9% (FY/20: 14.0%).

Net income1 increased by 29% (23% in constant currency) to €229 million (Q4/20: €177 million). Net income1 before special items decreased by 29% (-32% in constant currency) to €263 million (Q4/20: €372 million) mainly due to the mentioned negative effects on operating income. In FY/21, net income1 decreased by 17% (-14% in constant currency) to €969 million (FY/20: €1,164 million). Net income1 before special items decreased by 25% (-23% in constant currency) to €1,018 million (FY/20: €1,359 million).

Operating cash flow was €669 million (Q4/20: €584 million) with a margin of 14.4% (Q4/20: 13.3%). The increase was mainly due to improved working capital including contributions from FME25 and U.S. federal relief funding, partially offset by continued recoupment of the U.S. government’s payments received in 2020 under the CARES Act and lower tax payments related to COVID-19 reliefs in the prior year. In FY/21, operating cash flow was €2,489 million (FY/20: €4,233 million) with a margin of 14.1% (FY/20: 23.7%).

For FY/22, Fresenius Medical Care expects revenue2 and net income1,3 to grow at low- to mid-single-digit percentage rates in constant currency4. For the underlying assumptions please see Fresenius Medical Care’s press release at View Source." target="_blank" title="View Source." rel="nofollow">View Source

For further information, please see Fresenius Medical Care’s press release at View Source." target="_blank" title="View Source." rel="nofollow">View Source

1 Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA
2 FY/21 base: €17,619 million
3 FY/21 base: €1,018 million, before special items; FY/22 before special items
4 These targets are based on the 2021 results excluding the costs related to FME25 of €49 million (for net income). They are based on the outlined assumptions (View Source), in constant currency and exclude special items. Special items include further costs related to FME25 and other effects that are unusual in nature and have not been foreseeable or not foreseeable in size or impact at the time of giving guidance.

For a detailed overview of special items please see the reconciliation tables on pages 21-25 in the PDF.

Fresenius Kabi
Fresenius Kabi offers intravenously administered generic drugs, clinical nutrition and infusion therapies for seriously and chronically ill patients in the hospital and outpatient environments. The company is also a leading supplier of medical devices and transfusion technology products. In the biosimilars business, Fresenius Kabi develops products with a focus on oncology and autoimmune diseases.

• Good performance in Q4 supported by COVID-driven demand, not expected to continue through 2022
• North America with positive organic sales and EBIT growth despite supply chain challenges
• Asia-Pacific with anticipated organic sales decline due to price effects in China post successful participation in NVBP tenders
• Separate reporting of Biosimilars sales starting Q1/22

Sales remained on previous year’s level (decreased by -2% in constant currency) at €1,823 million (Q4/20: €1,815 million). Organic growth was -1%. Divestitures reduced sales growth by 1%. Positive currency translation effects (2%) were mainly related to the appreciation of the U.S. dollar and the Chinese yuan against the Euro.

In FY/21, sales increased by 3% (4% in constant currency) to €7,193 million (FY/20: €6,976 million). Organic growth was 4%. Negative currency translation effects of 1% were mainly related to the weakness of the U.S. dollar.

Sales in North America increased by 7% (organic growth: 2%) to €589 million (Q4/20: €549 million) driven by COVID-19 related extra demand. In FY/21, sales in North America decreased by 5% (organic growth: -2%) to €2,258 million (FY/20: €2,376 million).

Sales in Europe decreased by 2% (organic growth: 0%) to €664 million (Q4/20: €680 million) mainly due to the high prior-year base. In FY/21, sales in Europe increased by 3% (organic growth: 3%) to €2,544 million (FY/20: €2,458 million).

1 Before special items
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA

For a detailed overview of special items please see the reconciliation tables on pages 21-25 in the PDF.

Sales in Asia-Pacific decreased by 8% (organic growth: -13%) to €395 million (Q4/20: €428 million) due to the anticipated negative price effects from successful participation in NVBP (National Volume-Based Purchasing) tenders as well as the exceptionally high prior-year base. In FY/21, sales in Asia-Pacific increased by 10% (organic growth: 8%) to €1,643 million (FY/20: €1,497 million).

Sales in Latin America/Africa increased by 11% (organic growth: 12%) to €175 million (Q4/20: €158 million) due to ongoing COVID-19 related extra demand. In FY/21, sales in Latin America/Africa increased by 16% (organic growth: 23%) to €748 million (FY/20: €645 million).

EBIT before special items increased by 18% (12% in constant currency) to €279 million (Q4/201: €236 million) with a margin of 15.3% (Q4/201:13.0%). The excellent performance is primarily due to COVID-19 related extra demand, and cost savings in the Asia-Pacific region, mainly in China. The ongoing competitive situation, supply chain challenges, the flow-through effects of tenders in China were headwinds. There were broadly offsetting one time effects across the regions. In FY/21, EBIT before special items increased by 5% (7% in constant currency) to €1,153 million (FY/201: €1,095 million) with a margin of 16.0% (FY/201: 15.7%).

Net income1,2 increased by 20% (13% in constant currency) to €178 million (Q4/201: €148 million). In FY/21, net income1,2 increased by 7% (8% in constant currency) to €778 million (FY/201: €730 million).

Operating cash flow increased by 9% to €335 million (Q4/20: €307 million) with a margin of 18.4% (Q4/20: 16.9%) mainly due to a healthy operational performance. In FY/21, operating cash flow increased by 5% to €1,203 million (FY/20: €1,143 million) with a margin of 16.7% (FY/20: 16.4%).

For FY/22, Fresenius Kabi expects organic sales3 growth in a low-single-digit percentage range. Constant currency EBIT4 is expected to decline in a high-single- to low-double-digit percentage range. Both sales and EBIT outlook include expected COVID-19 effects.

Starting Q1/22, the sales of the Biosimilars business will be reported on a quarterly basis.

1 Before special items
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
3 FY/21 base: €7,193 million
4 FY/21 base: €1,153 million, before special items, FY/22 before special items

For a detailed overview of special items please see the reconciliation tables on pages 21-25 in the PDF.

Fresenius Helios
Fresenius Helios is Europe’s leading private hospital operator. The company comprises Helios Germany and Helios Spain (Quirónsalud) and the Eugin Group. Helios Germany operates 90 hospitals, ~130 outpatient centers and 6 prevention centers. Quirónsalud operates 49 hospitals in Spain as well as 88 outpatient centers and ~300 occupational risk prevention centers. In addition, the company is active in Latin America with 7 hospitals and as a provider of medical diagnostics.

• Sales growth at Helios Germany driven by increasing admissions and acquisitions
• Helios Spain with strong organic sales growth; EBIT growth influenced by exceptionally high prior-year base
• Separate reporting of Fertility Services starting Q1/22

Sales increased by 9% (9% in constant currency) to €2,882 million (Q4/20: €2,637 million). Organic growth was 5%. Acquisitions contributed 4% to sales growth. In FY/21, sales increased by 11% (11% in constant currency) to €10,891 million (FY/20: €9,818 million). Organic growth was 7%. Acquisitions contributed 4% to sales growth.

Sales of Helios Germany increased by 7% (organic growth: 4%) to €1,745 million (Q4/20: €1,637 million) primarily driven by increasing admissions. Acquisitions contributed 3% to sales growth. In FY/21, sales of Helios Germany increased by 6% (organic growth: 2%) to €6,733 million (FY/20: €6,340 million). Acquisitions contributed 4% to sales growth.

Sales of Helios Spain increased by 9% (9% in constant currency) to €1,084 million (Q4/20: €999 million). Organic growth of 9% was driven by the continuous high level of treatment activity and a consistently high level of demand for the occupational risk prevention services as well as good contributions from Latin America. In FY/21, sales of Helios Spain increased by 16% (17% in constant currency) to €4,021 million (FY/20: €3,475 million). Organic growth was 15%. Acquisitions contributed 2% to sales growth.

1 Before special items
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA

For a detailed overview of special items please see the reconciliation tables on pages 21-25 in the PDF.

EBIT1 of Fresenius Helios increased by 3% (3% in constant currency) to €339 million (Q4/20: €328 million) with a margin1 of 11.8% (Q4/20: 12.4%). In FY/21, EBIT1 of Fresenius Helios increased by 10% (10% in constant currency) to €1,127 million (FY/20: €1,025 million) with a margin1 of 10.3% (FY/20: 10.4%).

EBIT1 of Helios Germany increased by 9% to €171 million (Q4/20: €157 million) with a margin1 of 9.8% (Q4/20: 9.6%) driven by the positive business development as well as the compensation for COVID-19 related revenue shortfalls. In FY/21, EBIT1 of Helios Germany increased by 2% to €613 million (FY/20: €602 million) with a margin1 of 9.1% (FY/20: 9.5%).

EBIT1 of Helios Spain increased by 2% (3% in constant currency) to €162 million (Q4/20: €159 million) with a margin1 of 14.9% (Q4/20: 15.9%). EBIT growth was influenced by the exceptionally high prior-year base. In addition, higher costs for personnel, personal protective equipment and selected medical products, among others, had a negative impact.
In FY/21, EBIT1 of Helios Spain increased by 22% (24% in constant currency) to €514 million (FY/20: €420 million) with a margin1 of 12.8% (FY/20: 12.1%).

Net income1,2 increased by 1% to €227 million (Q4/20: €225 million). In FY/21, net income1,2 increased by 9% to €728 million (FY/20: €666 million).

Operating cash flow increased to €609 million (Q4/20: €434 million) with a margin of 21.1% (Q4/20: 16.5%) driven by the positive business development as well as stringent working capital management. In FY/21, operating cash flow increased to €1,204 million (FY/20: €1,149 million) with a margin of 11.1% (FY/20: 11.7%).

For FY/22, Fresenius Helios expects organic sales3 growth in a low- to mid-single-digit percentage range and constant currency EBIT4 growth in a mid-single-digit percentage range. Both sales and EBIT outlook include expected COVID-19 effects.

The Eugin Group contributed €133 million to sales and €19 million EBIT in 2021, with first-time consolidation effective April 1, 2021. Starting Q1/22, sales and EBIT of the Eugin Group will be reported under "Fertility Services" on a quarterly basis.

1 Before special items
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
3 FY/21 base: €10,891 million
4 FY/21 base: €1,127 million, FY/22 before special items

For a detailed overview of special items please see the reconciliation tables on pages 21-25 in the PDF.

Fresenius Vamed
Fresenius Vamed manages projects and provides services for hospitals and other health care facilities worldwide and is a leading post-acute care provider in Central Europe. The portfolio ranges along the entire value chain: from project development, planning, and turnkey construction, via maintenance and technical management to total operational management.

• Strong finish to the year with excellent organic sales and EBIT growth
• Project business recovering – back to the typical phasing with a strong Q4
• Rehabilitation business developing steadily despite continuous COVID-19 impact; technical service business remains robust

Sales increased by 30% (29% in constant currency) to €748 million (Q4/20: €577 million). Organic growth was 29%. In FY/21, sales increased by 11% (11% in constant currency) to €2,297 million (FY/20: €2,068 million). Organic growth was 11%.

Sales in the service business increased by 12% to €415 million (Q4/20: €372 million). Sales in the project business increased by 62% to €333 million (Q4/20: €205 million), driven by the good operating performance across all regions. In FY/21, sales in the service business increased by 10% to €1,580 million (FY/20: €1,435 million). Sales in the project business increased by 13% to €717 million (FY/20: €633 million).

1 Before special items
2 Net income attributable to shareholders of VAMED AG

For a detailed overview of special items please see the reconciliation tables on pages 21-25 in the PDF.

EBIT1 increased by 69% (69% in constant currency) to €66 million (Q4/20: €39 million) with a margin1 of 8.8% (Q4/20: 6.8%). This significant recovery is due to the good business performance in all regions. In FY/21, EBIT1 more than tripled (248% in constant currency) to €101 million (FY/20: €29 million) with a margin1 of 4.4% (FY/20: 1.4%).

Net income1,2 increased to €49 million (Q4/20: €25 million). In FY/21, net income1,2 increased to €67 million (FY/20: €2 million).

Order intake was €319 million in Q4/21 (Q4/20: €648 million) and €1,290 million in FY/21 (FY/20: €1,010 million). As of December 31, 2021, order backlog was at €3,473 million (December 31, 2020: €3,055 million).

Operating cash flow increased to €128 million (Q4/20: €74 million) with a margin of 17.1% (Q4/20: 12.8%) mainly due to an improved working capital development. In FY/21, operating cash flow increased to €151 million (FY/20: €78 million) with a margin of 6.6% (FY/20: 3.8%).

For FY/22, Fresenius Vamed expects organic sales3 growth in a high-single to low-double-digit percentage range and constant currency EBIT4 to return to absolute pre-COVID-19 levels (FY/19: €134 million). Both sales and EBIT outlook include expected negative COVID-19 effects.

1 Before special items
2 Net income attributable to shareholders of VAMED AG
3 FY/21 base: €2,297 million
4 FY/21 base: €101 million; FY/22 before special items

For a detailed overview of special items please see the reconciliation tables on pages 21-25 in the PDF.

Conference Call
As part of the publication of the results for FY 2021, a conference call will be held on February 22, 2022 at 1:30 p.m. CET (7:30 a.m. EST). All investors are cordially invited to follow the conference call in a live broadcast over the Internet at View Source Following the call, a replay will be available on our website.