The Fresenius Management SE Supervisory Board has unanimously appointed Sara Hennicken (41), currently Senior Vice President Global Treasury & Corporate Finance at Fresenius, to become the company’s new Chief Financial Officer as of September 1, 2022. She will succeed Rachel Empey (45), who joined the Management Board of Fresenius as CFO on August 1, 2017 and will leave the company at her own request at the end of August.

Sara Hennicken joined Fresenius in 2019. Previously, she spent 14 years in investment banking, including nine years at Deutsche Bank, lastly as Managing Director and Senior Client Executive in Corporate Finance Coverage before moving to Fresenius. Between 2005 and 2010 she worked for Citigroup in Frankfurt and London. Sara Hennicken studied economics in Germany and in the United States.

Rachel Empey said: “The good and trusting collaboration with my colleagues in the Management Board, and with my team has been personally fulfilling. Fresenius is a great company with outstanding prospects; together we have moved the company forward. The last years have been very intense, and challenging, yet also a great and very enriching experience. So, leaving was not an easy decision for me, but now I am looking forward to the next chapter of my life. I personally brought Sara Hennicken on board in 2019, and I know my duties and tasks are in good hands with her. I’m very happy for Sara and wish her a lot of luck, success and happiness in her new position, with the additional responsibility she will be taking on.”

Wolfgang Kirsch, Chairman of the Supervisory Board of Fresenius, said: “Rachel Empey further developed Fresenius’ finance department and made it ready for the future. During her time here – part of which was heavily impacted by the pandemic – she also set in motion important changes and improvements in her other areas of responsibility, such as IT. On behalf of the entire Supervisory Board, I want to thank her for all her contributions and hard work. In Sara Hennicken, we have an innovative, young and yet highly experienced financial expert from within the company who will assure continuity in this area but also bring in new ideas. She is ideally qualified for this position. Together with our CEO Stephan Sturm and her other Management Board colleagues, she will contribute to the future success of our healthcare group.”

Stephan Sturm, CEO of Fresenius, said: “I’m sorry that Rachel is leaving our company. Over these last years, we always worked well together, very collegially and with great trust, and I especially valued her as a sparring partner during our discussions about the company’s growth strategy. But, of course, I respect her decision, and wish Rachel all the very best for this new chapter of her life. At the same time, I am very much looking forward to working with Sara, who will enrich our management team with her personality, experience and ideas. We will be working together even more closely than before to create the optimal foundations for financing our healthy growth, and the sustainable success of our company.”

Sara Hennicken said: “I am very happy about the confidence and trust being placed in me, and greatly looking forward to the new tasks ahead. As a globally active healthcare company, Fresenius makes an important contribution to society with which I can very much identify. Over the past years, I’ve been able to realign my department and modernize our financing structure. The excellent group-wide collaboration with my colleagues has been especially valuable. In my new position I want to build on this, for the benefit of our company.”

Fresenius Kabi and the U.S. based company Cerus Corporation signed a new agreement for the production of systems for pathogen inactivation in blood components. The collaboration will help expanding access to pathogen-reduced blood components to patients. For many years, Cerus and Fresenius Kabi have collaborated regarding medical products specializing in pathogen inactivation for platelets and plasma. Since market launch of Cerus’ INTERCEPT systems, more than 11 million units have been in use worldwide.

Calcium Gluconate in Sodium Chloride Injection is now available in ready-to-administer non-DEHP, non-PVC containers, complementing the company’s existing vial presentations in the United States. Fresenius Kabi now has the broadest portfolio of Calcium Gluconate in Sodium Chloride Injection products available from any manufacturer in the United States.

• First steps in executing Fresenius Kabi’s “Vision 2026” growth strategy
  • Acquisition of majority stake in mAbxience significantly enhances Fresenius Kabi’s presence in high-growth biopharmaceuticals market 
  • Ivenix adds next-generation infusion therapy platform to transform product offering 
• Combined, these acquisitions will meaningfully increase the company’s scale over the next years and accelerate the Group’s growth 
• Acquisitions combined are expected to be broadly neutral to Group cash earnings per share¹ in 2022 and accretive by 2023 
• Transactions expected to close by mid-2022

¹ earnings before amortization and integration costs

Stephan Sturm, CEO of Fresenius, said: “Through these acquisitions we are further strengthening and leveraging Fresenius Kabi's position, as both perfectly complement the company's growth businesses in biopharmaceuticals and medical technology. We will continue allocating capital in a targeted manner to rigorously pursue the recently presented growth strategy of our health care Group which has defined Fresenius Kabi as top priority. In this way, we are creating even better conditions for providing ever better medicine to ever more people. At the same time, we create meaningful value for our shareholders.”

Michael Sen, CEO of Fresenius Kabi, said: “Expanding our MedTech business and broadening our presence in Biopharmaceuticals are key to our Vision 2026 program. Today’s announcements fit squarely into our plans. With the acquisition of Ivenix, we add the next generation infusion therapy platform; we complement and strengthen our existing infusion therapy offering and we create a superior portfolio for the US market. With mAbxience, we are making a step-change in our biopharmaceuticals profile. This is a highly complementary transaction in terms of biologics pipeline, manufacturing capabilities and the business model. mAbxience is two businesses in one company. mAbxience and Ivenix as portfolio advancements are good for patients, good for healthcare providers and our company.”
 

Acquisition of a majority stake in mAbxience significantly enhances Fresenius Kabi’s presence in high-growth biopharmaceuticals market

• Delivers on core growth vector “Broaden Biopharma” of “Vision 2026”
• Provides access to expertise and capabilities in one of the fastest-growing areas of healthcare, positioning Fresenius Kabi for accelerated medium- and long-term growth
• Follows a convincing industrial logic focused on a global, end-to-end vertically integrated biopharmaceuticals footprint
• Creates a strong partnership with excellent growth potential in attractive biosimilars market
• Comprises high-growth biologics Contract Development and Manufacturing (“CDMO”) market with three state-of-the-art biologics manufacturing facilities in Spain and Argentina
• Provides access to a highly cost competitive biologics manufacturing capacity with significant cost synergies expected for Fresenius Kabi’s biosimilars portfolio

Fresenius Kabi announced today that it has agreed to acquire a stake of 55% of mAbxience Holding S.L. (”mAbxience”). The purchase price will be a combination of €495 million upfront payment and milestone payments, strictly tied to the achievement of commercial and development targets.  The contractual provisions also include a put / call option scheme regarding the current owners’ remaining shares in mAbxience (45%).

mAbxience is a leading international biopharmaceutical company, focused on the rapidly developing biosimilars market. The company was founded in 2010 by Dr. Hugo Sigman and Dr. Silvia Gold as the biotechnology division of Insud Pharma S.L. mAbxience has established itself as a leader in the development and manufacturing of biological drugs, with two commercialized biosimilar products (Rituximab and Bevacizumab) and a mid-single-digit number of molecules across immunology and oncology expected to be launched globally in the years 2024 to 2029. This is supported by internal R&D laboratories and state-of-the-art manufacturing facilities in Spain and Argentina. In addition to highly competitive production costs for the internal programs, the manufacturing platform allows mAbxience to offer third party biological CDMO services, including a recent contract with AstraZeneca to produce the drug substance for its COVID-19 vaccine in Latin America. The company currently employs approximately 600 staff and generated sales of approx. €255 million in 2021. 

The acquisition of a majority stake in mAbxience follows Fresenius Kabi’s recently unveiled Vision 2026 strategy, delivering on one of the core growth vectors – to “Broaden Biopharma” – by expanding along the value chain and further enhancing the existing Fresenius Kabi biosimilars pipeline. 

Fresenius Kabi expects, through its in-house biosimilars programs and through its investment in mAbxience, to capture an overproportionate share of the underlying rapid growth in the biopharmaceutical market. Fresenius Kabi’s footprint in biopharmaceuticals will be significantly strengthened by broadening its biosimilars portfolio and by gaining access to the distinctive manufacturing capabilities of mAbxience. It will also allow Fresenius Kabi to provide end-to-end integrated biopharmaceutical solutions for customers from its state-of-the-art facilities.

mAbxience operates three state-of-the-art facilities for the production of biologic drug substance. This addresses a critical gap in Fresenius Kabi’s value chain, adding flexible, single-use biologic drug substance capacity that can be leveraged to provide competitive cost of production for the enlarged biosimilars portfolio. This manufacturing capability also offers end-to-end integrated biopharmaceutical solutions for customers and thus establishes a strategic foothold for Fresenius Kabi in the fast-growing biologic CDMO sector, complementing the existing small molecule API and fill & finish operations.

Once completed, the transaction is expected to deliver material operating and cost synergies for Fresenius Kabi, primarily driven by leveraging mAbxience’s manufacturing capabilities for Fresenius Kabi’s existing biosimilars business. 

The transaction remains subject to regulatory approvals and other customary closing conditions and is expected to close by mid-2022.
 

Ivenix strengthens Fresenius Kabi’s MedTech business and accelerates growth

• Delivers on core growth vector “Expand MedTech” of Vision 2026
• Provides next-generation infusion therapy platform for U.S. market
• Complements Fresenius Kabi’s global infusion therapy offering
• Provides Fresenius Kabi with key capabilities in hospital connectivity and creates new options for growth of MedTech business
• Significant scale and growth synergies expected

Fresenius Kabi announced today that it has agreed to acquire Ivenix, Inc. („Ivenix“), a specialized infusion therapy company. The purchase price will be a combination of US$240 million upfront payment and milestone payments, strictly linked to the achievement of commercial and operating targets.

Ivenix is a privately held company based in North Andover, Massachusetts, USA. The company has developed the technologically most advanced infusion system including a large volume pump (“LVP”) with administration sets, infusion management software tools, applications and analytics to inform care and advance efficiency. The Ivenix Infusion System’s innovative design and architecture sets a new standard in infusion safety, simplicity and interoperability. The system is centred around the patient and clinician and is designed to reduce infusion-related errors and drive down the total cost of ownership. After having received the U.S. Food and Drug Administration’s (FDA) approval, the Ivenix Infusion System was successfully launched in late 2021.

Ivenix’ Infusion System provides access to attractive growth potential for Fresenius Kabi in the large and growing infusion therapy market. The combination of Ivenix’ leading hardware and software products with Fresenius Kabi’s offerings in intravenous fluids and infusion devices will create a comprehensive and leading portfolio of premium products, forming a strong basis to enable sustainable growth in the high-value MedTech space.  

The transaction is subject to regulatory approvals and other customary closing conditions and is expected to close by mid-2022. 

Financing and implications on Group financials

mAbxience is expected to be accretive to Group cash earnings per share (earnings before amortization and integration costs) right after closing. Ivenix is expected to be neutral to Group cash earnings per share in 2025 and accretive from 2026 onwards. 

Combined, these acquisitions are expected to be broadly neutral to Group cash earnings per share in 2022 and accretive as of 2023. 

The transactions are currently expected to be financed by cash flow and available liquidity. 

Conference Call 

A telephone conference on the acquisition of a majority stake in mAbxience Holding S.L. and the acquisition of Ivenix, Inc. will be held on March 31, 2022 at 1:30 p.m. CEST (7:30 a.m. EDT). All investors are cordially invited to follow the conference call in a live broadcast over the Internet at www.fresenius.com/investors. Following the call, a replay will be available on our website.

The European Commission (EC) has granted Fresenius Kabi the marketing authorization for Stimufend®, the company’s pegfilgrastim biosimilar, for all approved indications of the reference medicine. Stimufend® stimulates the growth of certain white blood cells, which are essential to prevent or fight infections, a common life-threatening risk in patients receiving myelosuppressive chemotherapy. This is the company’s first approved biosimilar molecule used in oncology and its second biosimilar approved in Europe, expanding its autoimmune disease and oncology focused product portfolio. 

Dr. Carla Kriwet (51) will become the new CEO of Fresenius Medical Care, the world's leading provider of products and services for individuals with renal diseases, on January 1, 2023. The Supervisory Board of Fresenius Medical Care Management AG unanimously appointed her to succeed Rice Powell (66), who in accordance with the company’s age limit for Management Board members is stepping down when his contract ends on December 31, after 10 years heading the company. Like Rice Powell, Dr. Carla Kriwet will also be a member of the Management Board of Fresenius Management SE. Helen Giza, Chief Financial Officer of Fresenius Medical Care, will enter a new five-year contract, and in addition to her current positions as CFO and CTO will assume the position of Deputy CEO.

Dr. Carla Kriwet was most recently CEO and President of BSH Hausgeräte GmbH, a company with €15.6 billion in sales, 62,000 employees and 40 production plants around the world. From 2013 to 2020 she was with the health technology company Royal Philips N.V. in the United States, since 2017 as a member of the company’s Executive Board. At Philips she headed the Connected Care division, which includes the business areas Patient Care and Monitoring Solutions as well as Healthcare Informatics.

Previously, Dr. Carla Kriwet was a member of the Executive Board of the non-governmental organization Save the Children Germany in Berlin, and Chief Sales & Marketing Officer at the medical technology company Drägerwerk in Lübeck, Germany. Between 2003 and 2010 she held various management positions in the strategy department and in the Healthcare division of Linde AG, lastly as Head of Linde Healthcare Europe. Before that, she spent six years with the Boston Consulting Group, where, among other responsibilities, she headed consulting projects in healthcare. Dr. Carla Kriwet started her career in project management at ABB Daimler-Benz Transportation in India in 1995, after working as a volunteer for an SOS Children’s Village in Burundi and studying business at Switzerland’s University of St. Gallen, where she graduated with a doctorate degree.

Rice Powell joined Fresenius Medical Care in 1997, and as CEO of Fresenius Medical Care North America was appointed to the Management Board of Fresenius Medical Care in 2004. He has been the company’s CEO since January 1, 2013. Under his direction, Fresenius Medical Care significantly extended its global leadership, identifying emerging business areas such as value-based care and home dialysis early and then expanding successfully into them.

Rice Powell said: “After 25 years with this company, and a full decade as CEO, I look back with a lot of gratitude and pride at what we achieved during this time. Our products and services are more important than ever to our patients, and a fundamental part of their lives. As the world’s only provider of the full range of innovative therapies and products for people with renal diseases, we have outstanding prerequisites for our continued success. I want to thank all my colleagues – on the Management Board, the management team, and everyone in all our facilities worldwide – for their untiring efforts and support over the years. I’m very happy to know that our company will be in good hands in the future.”

Stephan Sturm, Chairman of the Fresenius Medical Care Management AG Supervisory Board and CEO of Fresenius, said: “I am very thankful to Rice Powell for his highly dedicated service over many years, and for his important contribution to our success. He played a key role in shaping Fresenius Medical Care, initiated future-looking developments and set in motion the necessary transformation of the company. On behalf of the entire Supervisory Board and the Management Board of Fresenius, I wish Rice all the very best for the next stage of his life, with more time for his family and hobbies. At the same time, I am very much looking forward to working with Dr. Carla Kriwet. I have come to know her as a highly skilled and bold manager with a lot of experience in the healthcare industry, clear ideas and a lot of empathy. People’s health and well-being are very close to her heart, and something she has worked for over the years in different organizations and constellations. I’m certain that working closely with Helen Giza, and together with the entire management team, she will successfully shape the transformation now underway and manage the challenges, not least those created by the pandemic, embrace with enthusiasm the numerous growth opportunities before us, and lead Fresenius Medical Care to continued success.”

Dr. Carla Kriwet said: “I am very much looking forward to taking on this new position and working together with my new colleagues. I fully identify with the vision of making the lives of the patients who have put their trust in us a little more worth living every day. And I’m convinced that bringing ever better medicine to ever more people goes hand in hand with economic success. Early in my professional development, I found my way into the healthcare business and have remained very closely connected to it ever since. Fresenius Medical Care is a globally active, leading and unique company that still has tremendous potential. I want to do my part to leverage this potential for the benefit of patients and employees, and in doing so also add shareholder value.”

The Supervisory Board of Fresenius SE & Co. KGaA will propose that the next Annual General Meeting on May 13, 2022 elect Dr. Christoph Zindel, 60, to the Supervisory Board. If elected, he will also join the Supervisory Board’s Audit Committee. As announced last year, Klaus-Peter Müller, 77, will leave the Supervisory Board at the end of the Annual General Meeting and turn over the Audit Committee’s chairmanship to Susanne Zeidler, 61. The next regular election of all shareholder representatives is scheduled for the 2025 Annual General Meeting.

Dr. Zindel has been a member of the Siemens Healthineers Managing Board since October 2019. He began his career as a practicing physician in surgery, internal medicine and nuclear medicine, before moving into the healthcare industry in 1998 as a Segment Manager at Siemens Healthcare. There he held various management positions in the magnetic resonance-tomography business division. After three years in the U.S., lastly as head of the Business Unit Hematology and Urinanalysis at Beckman Coulter in Miami, he returned to Siemens Healthineers in 2015 and headed the Business Line Magnetic Resonance. In 2018, Dr. Zindel was appointed President Diagnostic Imaging.

Klaus-Peter Müller has been a Member of the Supervisory Board of Fresenius SE (today Fresenius SE & Co. KGaA) and its Audit Committee since 2008. From 2010 until 2021 he also belonged to the Supervisory Board of Fresenius Management SE. A highly regarded financial expert, Klaus-Peter Müller worked at Commerzbank AG from 1966 to 2008 and served from 2001 to 2008 as Chief Executive Officer.

Wolfgang Kirsch, Chairman of the Supervisory Board of Fresenius, said: “Dr. Christoph Zindel has a background in medicine, extensive international experience and comprehensive knowledge of the healthcare industry. This makes him an outstanding addition to our Board. As for Klaus-Peter Müller, on behalf of the Supervisory Board I want to thank him for his long connection with Fresenius and his many important contributions to our success.”

Fresenius Kabi announced today that it has received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for its wireless Agilia® Connect Infusion System which includes the Agilia Volumetric Pump and the Agilia Syringe Pump with Vigilant® Software Suite-Vigilant Master Med technology. Both pumps are the first to be cleared by following TIR101 standards, which were developed by the Association for the Advancement of Medical Instrumentation (AAMI) in 2021. The product offering for hospitals and clinics enables the centralized distribution of drug libraries, warehousing of infusion data for reporting and analysis, and wireless maintenance and calibration of devices. The clearance is an important milestone for the company’s infusion therapy business in the U.S.

• Creation of new company combines strengths of three leading value-based care specialists
• Execution on strategic expansion along the renal care continuum significantly expands Fresenius Medical Care’s total addressable market in the U.S. from around $50 billion to around $170 billion
• Establishing independent and integrated value-based care offering in-line with FME25 plan of refining and further growing future Care Delivery segment in the U.S.  

Fresenius Medical Care, the world's leading provider of products and services for individuals with kidney diseases, announced today it has entered into a binding agreement to create an independent new company that combines Fresenius Health Partners, the value-based care division of Fresenius Medical Care North America, with InterWell Health, the leading physician organization driving innovation in the kidney care space in the U.S., and Cricket Health, a U.S. provider of value-based kidney care with a leading patient engagement and data platform. 

The merger brings together Fresenius Health Partners’ expertise in kidney care value-based contracting and performance, InterWell Health’s clinical care models and strong network of 1,600 nephrologists and Cricket Health’s tech-enabled care model that utilizes its proprietary informatics, StageSmart™️ and patient engagement platforms to create an innovative, stand-alone entity poised to transform kidney care.

Rice Powell, CEO of Fresenius Medical Care, said: “This effort is an important next step in executing Fresenius Medical Care’s growth strategy 2025 to further expand along the renal care continuum and to refine and grow our future operating model in Care Delivery in the U.S. as part of the FME25 transformation. In bringing together the expertise and competence of three leading partners we will be broadening our offer and adding significant value to patients with chronic kidney disease all over the U.S.” 

Bill Valle, CEO of Fresenius Medical Care North America and of the future Care Delivery segment for Fresenius Medical Care, said: “With leading capabilities, scale, and reach, the new company will be well positioned to transform kidney care and health equity in the U.S. This includes reducing hospital admissions and readmissions, slowing disease progression, increasing transplant referrals and rates, accelerating the transition to home dialysis, and improving clinical outcomes and quality of life for patients with lower overall costs for payors.” 

The new company, which will be fully consolidated by Fresenius Medical Care as the majority owner and operate under the InterWell Health brand, is valued at $2.4 billion. The merger will create an independent entity that expands into the $120 billion CKD stage 3 to 5 market. The new company targets to engage and manage the care of more than 270,000 people with kidney disease by 2025 and to manage around $11 billion medical cost in the same year. Bringing together the experience, data, technology, algorithms and network in a unique way, will drive growth and increase leverage of the combined assets resulting in continuously improving operating profit margins on medical cost under management and enhance return on invest capital in this asset-light business. 

The closing of the transaction is subject to regulatory review. Depending on the progress of such review, the company currently anticipates the transaction could close in the second half of 2022. Any book gains arising at closing of the transaction are not expected to be material on Fresenius Medical Care’s earnings and will be treated as a special item. Fresenius Medical Care expects that this part of the execution on its growth strategy 2025 will support the achievement of its financial 2025 targets.

• Business development significantly impacted by COVID-19 in 2021, effects are expected to continue into 2022
• Decline in excess mortality in the fourth quarter 
• 25th consecutive dividend increase to 1.35 EUR proposed
• Implementation of strategic priorities on track 

Rice Powell, Chief Executive Officer of Fresenius Medical Care, said: “Throughout 2021, COVID-19 has significantly impacted our patients’ and employees’ lives as well as Fresenius Medical Care as a company. 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


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.