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Fresenius Kabi announced today it has signed a multiyear agreement under which the Mayo Clinic is expected to purchase 10,000 Ivenix large-volume infusion pumps for its hospitals and clinics in Minnesota, Arizona, and Florida. This is the largest contract for Ivenix pumps Fresenius Kabi has signed to date, testament of the stringent implementation of the company’s Vision 2026 strategy.

Fresenius Kabi announced today it has signed a multiyear agreement under which the Mayo Clinic is expected to purchase 10,000 Ivenix large-volume infusion pumps for its hospitals and clinics in Minnesota, Arizona, and Florida. This is the largest contract for Ivenix pumps Fresenius Kabi has signed to date, testament of the stringent implementation of the company’s Vision 2026 strategy.

January 08

January 08, 2024
San Francisco, USA

42nd Annual JP Morgan Healthcare Conference

  • Fresenius makes use of the governmental compensation and reimbursement payments of up to €300 million (from the current perspective) provided for in the relief package for compensating additional costs caused by the increase in energy prices and implements the associated restrictions.
  • Fresenius subsequently suspends dividend for fiscal year 2023; Fresenius Management Board members and management bodies of other companies covered by the statutory bans cannot be granted bonuses or other variable compensation components for fiscal year 2023.
  • With the combination of the cash inflow of compensation and reimbursement payments and the dividend suspension, Fresenius reduces its leverage ratio (net debt/EBITDA) by around 20 to 25 basis points.
  • Increasing the value of the company is clear priority on the way to #FutureFresenius.

Today, the Fresenius Management Board has decided to make use of the compensation and reimbursement payments for German hospitals in the amount of up to €300 million (from the current perspective) provided for by the "Energy Relief Package" (“Entlastungspaket Energiehilfen“) under the Hospital Financing Act (“Krankenhausfinanzierungsgesetz”) to cover increased energy costs. Today's decision of the Management Board is subject to the approval of the Supervisory Board of Fresenius Management SE, which is expected to decide on this matter on December 6, 2023. Fresenius' use of the compensation and reimbursement payments is subject to far-reaching conditions.

Fresenius therefore implements the related restrictions of the legislator. Fresenius Management Board will propose to the Annual General Meeting 2024 of Fresenius SE & Co. KGaA not to distribute a dividend for the fiscal year 2023. In addition, the Management Board members of Fresenius Management SE and management bodies of other companies covered by the statutory bans cannot be granted bonuses or other variable compensation components in the fiscal year 2023.

The decision is in line with the central objective of the #FutureFresenius strategy: the sustainable development and value enhancement of the company. The cash inflow of compensation and reimbursement payments as well as the dividend suspension will reduce the company's debt and consequently improve the leverage ratio by around 20 to 25 basis points. The reduction in debt will have a positive effect on net interest expense and ultimately on earnings per share. Furthermore, the compensation and reimbursement payments of up to €300 million (from the current perspective) will largely offset the additional costs of Helios Germany in 2023 caused directly or indirectly by the increase in energy prices.

"#FutureFresenius is our guideline for making and implementing strategically important decisions. Against this background, this is the right step for our company. We are strengthening our company’s intrinsic value. The lower level of debt affords us greater flexibility to make even better use of our market opportunities. We act with foresight and keep an eye on the sustainable development of the company and thus the future of patient care," said Fresenius CEO Michael Sen.

Fresenius is of the opinion that the statutory bans provided for in the "Energy Relief Package" („Entlastungspaket Energiehilfen“) are unconstitutional and that Fresenius' fundamental rights have been violated in view of the significant interference in the hospital financing system associated with this. Fresenius is therefore examining whether and in what form legal action should be taken.

In addition to operating performance improvement of the core business, the successfully progressing cost and efficiency program, the simplification of the Group structure through the deconsolidation of Fresenius Medical Care as well as the divestments of non-core businesses within the business segments, the compensation and reimbursement payments and the suspension of the dividend support the long-term strengthening of the Company.

Notwithstanding the legally required suspension of dividend payments for the fiscal year 2023, Fresenius maintains its dividend policy for the future. In line with its progressive dividend policy, Fresenius continues to aim to increase the dividend in line with growth in earnings per share (in constant currency, before special items), or at least maintain the dividend at the previous year's level.

This press release contains forward-looking statements that are subject to certain risks and uncertainties. Future results may differ substantially from those currently anticipated due to various risk factors and uncertainties, such as changes in the business, economic, and competitive situation, changes in legislation, results of clinical trials, exchange rate fluctuations, uncertainties regarding litigation or investigative proceedings, the availability of financing, and unforeseen effects of international conflicts. Fresenius assumes no responsibility to update the forward-looking statements contained in this press release.

  • Fresenius makes use of the governmental compensation and reimbursement payments of up to €300 million (from the current perspective) provided for in the relief package for compensating additional costs caused by the increase in energy prices and implements the associated restrictions.
  • Fresenius subsequently suspends dividend for fiscal year 2023; Fresenius Management Board members and management bodies of other companies covered by the statutory bans cannot be granted bonuses or other variable compensation components for fiscal year 2023.
  • With the combination of the cash inflow of compensation and reimbursement payments and the dividend suspension, Fresenius reduces its leverage ratio (net debt/EBITDA) by around 20 to 25 basis points.
  • Increasing the value of the company is clear priority on the way to #FutureFresenius.

Today, the Fresenius Management Board has decided to make use of the compensation and reimbursement payments for German hospitals in the amount of up to €300 million (from the current perspective) provided for by the "Energy Relief Package" (“Entlastungspaket Energiehilfen“) under the Hospital Financing Act (“Krankenhausfinanzierungsgesetz”) to cover increased energy costs. Today's decision of the Management Board is subject to the approval of the Supervisory Board of Fresenius Management SE, which is expected to decide on this matter on December 6, 2023. Fresenius' use of the compensation and reimbursement payments is subject to far-reaching conditions. 

Fresenius therefore implements the related restrictions of the legislator. Fresenius Management Board will propose to the Annual General Meeting 2024 of Fresenius SE & Co. KGaA not to distribute a dividend for the fiscal year 2023. In addition, the Management Board members of Fresenius Management SE and management bodies of other companies covered by the statutory bans cannot be granted bonuses or other variable compensation components in the fiscal year 2023.

The decision is in line with the central objective of the #FutureFresenius strategy: the sustainable development and value enhancement of the company. The cash inflow of compensation and reimbursement payments as well as the dividend suspension will reduce the company's debt and consequently improve the leverage ratio by around 20 to 25 basis points. The reduction in debt will have a positive effect on net interest expense and ultimately on earnings per share. Furthermore, the compensation and reimbursement payments of up to €300 million (from the current perspective) will largely offset the additional costs of Helios Germany in 2023 caused directly or indirectly by the increase in energy prices.

"#FutureFresenius is our guideline for making and implementing strategically important decisions. Against this background, this is the right step for our company. We are strengthening our company’s intrinsic value. The lower level of debt affords us greater flexibility to make even better use of our market opportunities. We act with foresight and keep an eye on the sustainable development of the company and thus the future of patient care," said Fresenius CEO Michael Sen. 

Fresenius is of the opinion that the statutory bans provided for in the "Energy Relief Package" („Entlastungspaket Energiehilfen“) are unconstitutional and that Fresenius' fundamental rights have been violated in view of the significant interference in the hospital financing system associated with this. Fresenius is therefore examining whether and in what form legal action should be taken.

In addition to operating performance improvement of the core business, the successfully progressing cost and efficiency program, the simplification of the Group structure through the deconsolidation of Fresenius Medical Care as well as the divestments of non-core businesses within the business segments, the compensation and reimbursement payments and the suspension of the dividend support the long-term strengthening of the Company. 

Notwithstanding the legally required suspension of dividend payments for the fiscal year 2023, Fresenius maintains its dividend policy for the future. In line with its progressive dividend policy, Fresenius continues to aim to increase the dividend in line with growth in earnings per share (in constant currency, before special items), or at least maintain the dividend at the previous year's level.

This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, the availability of financing and unforeseen impacts of international conflicts. 
Fresenius does not undertake any responsibility to update the forward-looking statements in this release.

Prof. Iwasaki works on numerous committees, such as the European Molecular Biology Organization and the American Academy of Arts and Sciences. © Yale School of Medicine, EKFS/Vero Bielinski

Prof. Dr. Akiko Iwasaki, Ph.D., is a Sterling Professor of Immunobiology and Molecular, Cellular and Developmental Biology at Yale University in the US. She conducts research on Covid-19 and long Covid. Prof. Iwasaki has led a research group at Yale University that investigates the mechanisms of immune defense in Long Covid, making a significant contribution to long Covid research. Prof. Iwasaki’s research interests also include a number of other topics, such as respiratory viral infections, innate immunity, and autophagy.

Fresenius editor Brigitte Baas speaks with Prof. Akiko Iwasaki, Yale professor and laureate of the Else Kröner Fresenius Prize for Medical Research 2023, about her work.

Professor Iwasaki, an important part of your work focuses on post-acute infection syndromes, including long Covid and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Please explain to our readers what ME/CFS is, how it manifests itself, and how this condition relates to long Covid. 

Prof. Dr. Akiko Iwasaki: ME/CFS is a systemic condition manifested mainly by a variety of different neurological and immunological symptoms and accompanied by chronic fatigue not relieved by sleep or rest. 

Patients with this disorder suffer from exacerbations of symptoms following physical, cognitive, or emotional exertion beyond tolerated limits. These episodes of symptoms worsening may last for several days, weeks, months, or even be associated with irreversible decline.

What symptoms, exactly?

Prof. Iwasaki: Prominent features we commonly observe in ME/CFS include neurocognitive impairment, the so-called "brain fog", unrefreshing sleep, pain, sensory disorders, in technical jargon called sensory paresthesias, gastrointestinal problems like fullness, bloating, abdominal pain, and nausea, as well as various disorders of the autonomic nervous system. 
Up to three-quarters of people with ME/CFS cases report an infection-like episode preceding the onset of their illness, while others report triggers that are apparently non-infectious or that appear to reflect a gradual build-up of symptoms. 

What are the similarities between these two conditions – long Covid and ME/CFS – in terms of their genesis and progression?

Prof. Iwasaki: We have repeatedly found that a proportion of people with post-acute infection syndrome (PAIS) – which is known to be triggered by various pathogens – also meet the diagnostic criteria for chronic fatigue syndrome. 

Similarly, roughly half of patients with long Covid also meet the criteria for chronic fatigue syndrome. They also develop the sustained fatigue states typical of ME/CFS. Therefore, we are very excited to use the EKFS prize funding, to compare the immune phenotypes between ME/CFS and long Covid head-to-head to understand the similarities and differences even better. 
 

"Roughly half of patients with long Covid also meet the criteria for chronic fatigue syndrome."

What other research results have you been able to achieve in the field of long Covid? 

Prof. Iwasaki: I have been working with talented and dedicated collaborators to better understand the underlying pathobiology of long Covid. We are studying the deep immune phenotyping of people with long Covid, comparing it with those who have recovered from Covid, and those who never had Covid and are healthy. After looking at thousands of different factors, we see interesting differences in the immune signatures. For example, people with long Covid have lower levels of circulating cortisol, altered T and B cell responses, and reactivation of Epstein-Barr viruses (EBV). 

And how exactly are you going to use these findings now for your future work? 

Prof. Iwasaki: What we want to do is to extend the analysis to ME/CFS and understand what people with ME/CFS have in terms of their immune phenotypes, which tell us a lot about the history and the story behind how they got there and can help us better understand the underlying pathogenesis of the disease. 

You won this year’s Else Kröner Fresenius Prize for Medical Research, which the Else Kröner-Fresenius Foundation (EKFS) awards to honor outstanding scientists. What does this award mean to you personally? 

Prof. Dr. Akiko Iwasaki: This prize is a tremendous recognition of my team's work on antiviral immune responses, and I am humbled to be among the scientists who have received this prize in the past. But this recognition also speaks volumes about the Else Kröner-Fresenius-Foundation itself, which is boldly and publicly recognizing the post-acute infection syndromes as diseases of worldwide significance. This is a tremendous win for the patients who have advocated for decades to shed light on these diseases, which have historically been ignored and dismissed by the medical and biomedical communities. 

"We want to determine the underlying mechanisms of post-acute infection syndromes. We are considering several potential hypotheses here." © Yale School of Medicine, EKFS/Vero Bielinski

The EKFS prize is endowed with 2.5 million euros. For which research projects exactly will you use the prize money? 

Prof. Iwasaki: We want to determine the underlying mechanisms of post-acute infection syndromes. We are considering several potential hypotheses here, including persistent pathogens, autoimmunity, reactivation of herpesviruses, and inflammatory changes in tissue function. Even if you clear the virus from the nose and throat, there may be a reservoir of virus somewhere in the body that continues to replicate and trigger chronic inflammation. Persistent pathogens in the body are our hypothesis No #1. We have started a clinical trial to see if antiviral treatment can help alleviate long Covid.

What other hypotheses are you investigating? 

Prof. Iwasaki: Our second hypothesis is autoimmunity. There may be a relationship between autoimmunity that is triggered by a viral infection and long Covid. Hypothesis No #3 is the reactivation of latent viruses. We see evidence of EBV reactivation in people with long Covid. Finally, we have shown that even a mild Covid confined to the lung can lead to long-term inflammation in the brain. In my lab at Yale Medicine School, we want to do comparative studies of ME/CFS patients and long Covid patients to find out how exactly these two syndromes are biologically similar. By studying both diseases, we hope to better understand common and different mechanisms of the disease. Together with my team, I will use the EKFS prize money for this groundbreaking research.

To ultimately develop therapies that still do not exist to date. 

Prof. Iwasaki: Yes, that is exactly what we want ultimately: to develop therapies that will help people with long Covid, ME/CFS and other post-acute infection syndromes. 
 

"There is undoubtedly a major danger of misdiagnosing PAIS patients as having a psychiatric disorder"

How exactly do you yourself – or other researchers – develop effective therapies for long Covid and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS for short) from all these findings? 

Prof. Akiko Iwasaki: Before we can develop good treatments, we need to understand the disease very well. We find for example that persistent viruses or viral infections are causing long Covid in a subset of people. Then, by understanding the biomarkers, we can provide antivirals or antibodies to remove the source of the problem. This knowledge can be used to identify and target the triggering virus in ME/CFS patients. If parts of long Covid patients suffer from autoimmunity, by understanding the biomarkers associated with this group, we can begin to treat these people with immune-modifying agents. The same is true for the same biomarkers in ME/CFS. These are some examples of how these findings can help find the right treatments for people with PAIS.

 

And how far along are you and your team, or other researchers as well, here? Are we talking weeks, months, or years before we can get a handle on long Covid and help patients? 

Prof. Iwasaki: Science takes a long time to understand the causes of disease. It will not be weeks or months before we have a handle on long Covid. However, with the efforts of many groups, including ours, we are getting closer and closer to the knowledge we need. In parallel, many clinical trials are beginning to understand empirically which drugs might benefit people with long Covid. It will take a concerted global effort to get there as soon as possible.

Many people still see long Covid as a mental disorder. Even doctors and scientists admit that there may be a psychosomatic component. You have been working intensively on research into long Covid, almost since the outbreak of the Corona crisis. What is your assessment: does the psyche really play a decisive role in the development and course of long Covid? Can psychological factors or a corresponding disposition be used to explain the development of long Covid – or are these just wrong assumptions? 

Prof. Iwasaki: Based on our data so far, immunological factors alone are able to classify people with long Covid vs. those who don't have long Covid with 94% accuracy. This means that we do not need to rely on other explanations, including psychological ones. Clinicians who are unfamiliar with PAIS may resort to a psychiatric or psychological diagnosis. There is undoubtedly a major danger of misdiagnosing PAIS patients as having a psychiatric disorder – because in this case, they may receive the wrong treatment and miss out on the right therapies and medications. This may even be detrimental to their recovery. 
 

"Studies show that vaccination prior to acquiring SARS-CoV-2 reduces the risk of developing long Covid later on by ~30 %"

How well does vaccination actually protect a person against long Covid? 

Prof. Iwasaki: Studies show that vaccination prior to acquiring SARS-CoV-2 reduces the risk of developing long Covid later on by ~30 %. 

The Else Kröner-Fresenius-Foundation supports research projects, which include projects from up-and-coming young scientists. What advice would you like to give to the next generation in science? 

Prof. Iwasaki: My advice to young scientists is to find the area of science that really excites them and devote themselves fully to its pursuit. That applies to any career. But, especially in science, it takes everything you need to begin to chip away at the mystery. In the long run, to be successful at anything, you have to enjoy it and enjoy yourself while doing it. 
I have always been passionate about promoting the next generation of scientists. As a society, if we want to ensure a more sustainable and healthier future, we need to invest in basic science, and to do that, we must invest in the people who will carry out our future science.

In addition to your scientific research, you are teaching at Yale, and you work on numerous committees. But on top, you have another ‘side job' that has made you very well known, especially at the beginning of the pandemic: You are active on X, formerly Twitter, with about 200,000 followers. Why do you think it is right and important to publish on this channel regularly? 

Prof. Iwasaki: I use X to post fact-based information about the virus, the immune system, and the vaccines. I felt the need to speak out on these issues, in the midst of misinformation and disinformation affecting millions of people around the world. As scientists, we have an obligation not only to communicate our own scientific findings, but also to use our expertise to dispel misinformation. I also think representation is important. I am an Asian American woman who is underrepresented as an "expert voice" in the media. I appreciate the opportunity to be one of those voices that provide people with accurate information. 
 

"If we want to increase our productivity in science and medicine, we need a diverse team, including women and underrepresented minorities" © Yale School of Medicine, EKFS/Vero Bielinski

You also advocate for equity and diversity in science. You call for and promote greater participation in science by female academics as well as people with a migration background. Why is this still necessary today – hasn't academia already become more equal? 

Prof. Iwasaki: We still have a long way to go to achieve equality in science. Research shows that a diverse workforce helps enhance creativity, productivity, problem solving, innovation, loyalty, and teamwork. If we want to increase our productivity in science and medicine, we need a diverse team, including women and underrepresented minorities. So even for purely selfish reasons alone, diversity is important to me. Of course, there are a myriad of other reasons why diversity makes sense.

This all sounds like a fulfilling, but also very busy, scientific, and public life. Do you have any spare time at all, and if so, what do you enjoy doing most in your leisure time? 

Prof. Iwasaki: My time away from science is very precious to me. I enjoy most spending it with my family, whether it is going on a trip together or just enjoying a meal together at home. I love spending time with my two teenage daughters and learning from them about the world from their own perspectives. I love spending time with my husband. We enjoy discussing not only science, but everything else from politics to psychology. Whenever possible, I love to visit my parents and my sister and her family in Japan. Even though I left Japan as a teenager, it still forms the core of who I am. I am lucky enough to have another sister who lives in the US, and I get to see her at least once a year. Aside from that, I also enjoy reading novels, watching movies, and doing yoga. 

Contact

Else Kröner-Fresenius-Stiftung
Geschäftsstelle Bad Homburg v.d.H.
Louisenstraße 120
61348 Bad Homburg v.d.H.
kontakt@ekfs.de

  • Deconsolidation is a landmark in the implementation of the #FutureFresenius program and a historic day for both companies
  • Reducing complexity is a prerequisite for greater flexibility as well as more efficient and faster decision-making and the basis for long-lasting economic success
  • Fresenius remains the largest shareholder of Fresenius Medical Care with an unchanged 32 percent of the share capital

Fresenius has successfully completed the deconsolidation of Fresenius Medical Care: The change in legal form was entered in the commercial register on November 30, 2023, and thereby took effect after the Senate of the Bamberg Higher Regional Court had granted Fresenius Medical Care's applications for approval in full. 

"The deconsolidation of Fresenius Medical Care is a landmark in the implementation of our #FutureFresenius strategy and a historic day for both companies. We are reducing complexity and creating the conditions for greater flexibility and more efficient and faster decision-making. Fresenius Medical Care will gain a greater degree of freedom as a result of the deconsolidation. This also means greater responsibility. Both companies can now concentrate on what they do best: working for the well-being of patients in their respective segments," said Michael Sen, CEO of Fresenius. "We are redirecting the company's focus with #FutureFresenius and creating the basis for long-lasting economic success. The solid business performance in recent quarters shows that this is the right path for us."

The shareholders of Fresenius Medical Care had already approved the change in legal form from a partnership limited by shares (KGaA) to a stock corporation (AG) by a majority of more than 99% at an Extraordinary General Meeting held on July 14, 2023. Following the change in legal form, Fresenius Medical Care is no longer part of the consolidated subsidiaries of Fresenius. Fresenius continues to hold 32 percent of Fresenius Medical Care's share capital and therefore remains the company's largest shareholder. With the deconsolidation, Fresenius Medical Care's accounting treatment will change from IFRS 5 to equity method accounting.

Fresenius Medical Care was formed in 1996 from the merger of Fresenius' dialysis division with the U.S. dialysis provider National Medical Care (NMC). The combination of Fresenius' product business and NMC's service business has made the company the world's leading and uniquely vertically integrated dialysis provider. Since then, Fresenius Medical Care has increased considerably in size and value as a result of organic growth and acquisitions: Revenue and the number of patients have increased sevenfold, while the number of employees has increased fivefold.

This press release contains forward-looking statements that are subject to certain risks and uncertainties. Future results may differ substantially from those currently anticipated due to various risk factors and uncertainties, such as changes in the business, economic, and competitive situation, changes in legislation, results of clinical trials, exchange rate fluctuations, uncertainties regarding litigation or investigative proceedings, the availability of financing, and unforeseen effects of international conflicts. Fresenius assumes no responsibility to update the forward-looking statements contained in this press release.

  • Deconsolidation is a landmark in the implementation of the #FutureFresenius program and a historic day for both companies
  • Reducing complexity is a prerequisite for greater flexibility as well as more efficient and faster decision-making and the basis for long-lasting economic success
  • Fresenius remains the largest shareholder of Fresenius Medical Care with an unchanged 32 percent of the share capital

 

Fresenius has successfully completed the deconsolidation of Fresenius Medical Care: The change in legal form was entered in the commercial register on November 30, 2023, and thereby took effect after the Senate of the Bamberg Higher Regional Court had granted Fresenius Medical Care's applications for approval in full.

"The deconsolidation of Fresenius Medical Care is a landmark in the implementation of our #FutureFresenius strategy and a historic day for both companies. We are reducing complexity and creating the conditions for greater flexibility and more efficient and faster decision-making. Fresenius Medical Care will gain a greater degree of freedom as a result of the deconsolidation. This also means greater responsibility. Both companies can now concentrate on what they do best: working for the well-being of patients in their respective segments," said Michael Sen, CEO of Fresenius. "We are redirecting the company's focus with #FutureFresenius and creating the basis for long-lasting economic success. The solid business performance in recent quarters shows that this is the right path for us."

The shareholders of Fresenius Medical Care had already approved the change in legal form from a partnership limited by shares (KGaA) to a stock corporation (AG) by a majority of more than 99% at an Extraordinary General Meeting held on July 14, 2023. Following the change in legal form, Fresenius Medical Care is no longer part of the consolidated subsidiaries of Fresenius. Fresenius continues to hold 32 percent of Fresenius Medical Care's share capital and therefore remains the company's largest shareholder. With the deconsolidation, Fresenius Medical Care's accounting treatment will change from IFRS 5 to equity method accounting.

Fresenius Medical Care was formed in 1996 from the merger of Fresenius' dialysis division with the U.S. dialysis provider National Medical Care (NMC). The combination of Fresenius' product business and NMC's service business has made the company the world's leading and uniquely vertically integrated dialysis provider. Since then, Fresenius Medical Care has increased considerably in size and value as a result of organic growth and acquisitions: Revenue and the number of patients have increased sevenfold, while the number of employees has increased fivefold.

 

This release contains forward-looking statements that are subject to certain risks and uncertainties. Future results may differ substantially from those currently anticipated due to various risk factors and uncertainties, such as changes in the business, economic, and competitive situation, changes in legislation, results of clinical trials, exchange rate fluctuations, uncertainties regarding litigation or investigative proceedings, the availability of financing, and unforeseen effects of international conflicts. Fresenius assumes no responsibility to update the forward-looking statements contained in this press release.

Fresenius Kabi and its license partner Formycon announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for FYB202, a Ustekinumab biosimilar candidate. FYB202 references Johnson & Johnson’s Stelara®*, a human monoclonal antibody for the treatment of immune-mediated disorders.

The FDA submission acceptance underscores Fresenius Kabi’s and Formycon’s unwavering commitment to improving patient access to high-quality biopharmaceuticals worldwide. For more information, please see the website of Fresenius Kabi.

* Stelara® is a registered trademark of Johnson & Johnson

 

Fresenius Medical Care, the world's leading provider of products and services for individuals with renal diseases, resolved a legal dispute with the U.S. government, for accounts receivable in legal dispute, and entered into a final and legally binding settlement agreement today, whereby the company will receive a payment from the U.S. government. 

Fresenius Medical Care had filed a complaint against the United States in 2019. This complaint sought to recover monies owed to the company by the U. S. Department of Defense under the Tricare program, for services on or before January 11, 2023. 

Tricare provides reimbursement for dialysis treatments and other medical care provided to members of the military services, their dependents and retirees. The litigation challenged unpublished administrative actions by Tricare administrators to reduce the rate of compensation paid for dialysis treatments provided to Tricare beneficiaries based on a recasting of invoicing codes. Tricare administrators had acknowledged the unpublished administrative action and declined to change or abandon it.

The now executed settlement agreement resolves the dispute underlying the complaint and concludes the litigation. 

As a consequence of the settlement agreement, both revenue and operating income will be positively impacted. In previous reporting periods, the negative impact related to this matter had not been treated as special item due to its operational nature. Fresenius Medical Care therefore expects a net positive impact on operating income (guidance basis)1 of approx. EUR 175 million in the 4th quarter 2023. 

The company had previously expected in fiscal year 2023 operating income (guidance basis)1 to grow by a low-single-digit percentage rate, compared to previous year (2022 basis: EUR 1,540 million). 

As a consequence of the settlement agreement, Fresenius Medical Care today raises its earnings outlook. The company now expects operating income (guidance basis)1 to grow by 12 to 14 percent in fiscal year 2023, compared to previous year. All other elements of the 2023 outlook, as published, remain unchanged.

In line with its disciplined financial policy, Fresenius Medical Care intends to use the agreed settlement payment to reduce its net financial debt and therefore deleverage the balance sheet.

Operating income, as presented in the outlook, is on a constant currency basis and excluding special items. Special items will be provided as separate KPI (“Operating income excluding special items”) to capture effects that are unusual in nature and have not been foreseeable or not foreseeable in size or impact at the time of giving guidance. These items are excluded to ensure comparability of the figures presented with the Company’s financial targets which have been defined excluding special items.
As described in FME’s public reports for FY 2022, special items included costs related to the FME25 program, the impact of the war in Ukraine, the impact of hyperinflation in Turkiye, the Humacyte investment remeasurement and the net gain related to InterWell Health. Additionally, the FY 2022 basis for the 2023 outlook was adjusted for U.S. Provider Relief Funding. For FY 2023, special items include costs related to the FME25 program, the Humacyte investment remeasurement, the costs associated with the legal form conversion and effects from legacy portfolio optimization.

This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to various factors, including, but not limited to, changes in business, economic and competitive conditions, legal changes, regulatory approvals, impacts related to the COVID-19 pandemic results of clinical studies, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.

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