Fresenius Kabi announced today it has introduced Cyclophosphamide for Injection, USP, a generic substitute for Cytoxan, for use in treating several forms of cancer. The introduction adds another life-saving treatment to Fresenius Kabi’s broad oncology portfolio that offers lower-cost options for treating a wide range of cancers.

For more information, please see the website of Fresenius Kabi.
 

The Fresenius Group achieved a sound climate-rating from the non-profit organization CDP of B. Further, our joint efforts as healthcare Group in increasing ESG reporting transparency and coordinated climate-related protection measures resulted in an improved water-ranking of B-. CDP is one of the most renowned climate and environmental rankings in the capital market. Investors use the annual results to evaluate climate protection activities and climate-related risks and opportunities of the companies assessed. As a healthcare Group, we have a special responsibility both to ensure the quality of our products and services, and protecting health and environment.

mAbxience, a Fresenius Kabi majority-owned Group, today announced a CDMO agreement with Biosidus for the manufacture of the ingredient agalsidase beta used in the treatment of Fabry disease. Under the agreement, mAbxience will be responsible for the manufacture of the active ingredient, which is developed by Biosidus as a biosimilar of Fabrazyme®.

This agreement strengthens mAbxience position in the CDMO sector and demonstrates its ability to collaborate in the development and manufacture of complex, high-value treatments. 
 

Fresenius Kabi announced today the immediate availability in the U.S. of Posaconazole Injection, a generic substitute for Noxafil®*, for the treatment or prevention of serious fungal infections. It is the newest addition to the company’s portfolio of more than 30 anti-infective molecules.

For more information, please see the website of Fresenius Kabi.

*Noxafil® is a registered trademark of Merck Sharp & Dohme LLC.
 

Fresenius has signed the World Economic Forum's Zero Health Gaps Pledge ahead of this year's World Economic Forum in Davos. This commitment to promoting equal opportunities in healthcare is part of the Global Health Equity Network (GHEN) to advance a shared vision of equitable healthcare in line with the UN Sustainable Development Goals (SDGs).

Improving people's health and advancing patient care is Fresenius' corporate purpose and therefore also an important part of the company's ESG strategy.

The full press release is available in the "Media" section of the website.
 

mAbxience, a Fresenius Kabi majority-owned Group, today announced a strategic licensing agreement with Intas Pharmaceuticals Ltd for Etanercept biosimilar to target autoimmune diseases. Under the agreement, mAbxience will develop, manufacture, and supply the Etanercept biosimilar from its state-of-the-art, Good Manufacturing Practices (GMP)-approved facilities, and Intas will receive the rights to commercialize in more than 150 countries, including Europe and the United States.

This collaboration demonstrates mAbxience’s commitment to addressing the pressing need for innovative and affordable treatment options for autoimmune diseases. 

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 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.

• 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.

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