Fresenius, via its operating company Fresenius Kabi, announced that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Applications (MAAs) for its biosimilar candidates of Prolia® (denosumab) and Xgeva® (denosumab). The two applications include all indications covered by the reference products, respectively, for treating different conditions including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that have spread to the bone, and giant cell tumor of the bone. The EMA Marketing Authorization Applications’ acceptance is the latest development in Fresenius Kabi’s continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Growing the company's Biopharma platform is a substantial cornerstone of #FutureFresenius. Prolia® and Xgeva® are registered trademarks of Amgen Inc.

Fresenius, via its operating company Fresenius Kabi, announced today the immediate availability of its biosimilar Tyenne® (tocilizumab-aazg) in a subcutaneous formulation in the U.S, continuing its (Bio)Pharma momentum. With this launch Fresenius is increasing access to affordable and cost-effective treatment options for use in the treatment of chronic autoimmune diseases. This is another important milestone in accelerating the company’s strong (Bio)Pharma momentum, a substantial cornerstone of #FutureFresenius. Tyenne®, the company’s third biosimilar in the U.S., was launched in an intravenous (IV) formulation in April this year.

Fresenius published its first Sustainability Highlights Report today. In the online report, the company presents its sustainability strategy, ambitions and highlights. In addition, the company reports on Scope 3 emissions for the first time, thereby creating full transparency across the entire value chain.

The rating agency S&P Global Ratings today revised the credit outlook for Fresenius SE from negative to stable. The rating was affirmed at BBB. In particular, S&P acknowledged Fresenius's improved operating performance, its simplified structure and capacity to deliver on its profitable growth plans. "The revised outlook is further proof that #FutureFresenius is paying off. It confirms our focus on profitable growth, liquidity, and capital efficiency. Based on the operational strength of our operating companies Fresenius Kabi and Fresenius Helios, we expect to be within our self-imposed leverage target corridor by year end," said Fresenius CFO Sara Hennicken. Fresenius is rated investment grade by the three leading rating agencies S&P Global Ratings (BBB/stable), Moody's (Baa3/stable) and Fitch (BBB-/stable). The company expects that it will be within its self-imposed leverage corridor of 3.0 to 3.5x net debt/EBITDA by the end of 2024.

Fresenius, via its Operating Company Fresenius Kabi, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for its biosimilar candidate of Prolia® (denosumab) and Xgeva® (denosumab). The denosumab biosimilar is indicated for the treatment of osteoporosis in men and women, including glucocorticoid-induced osteoporosis, and bone loss due to prostate or breast cancer. This BLA submission acceptance is the latest development in Fresenius Kabi’s continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Expanding the company’s Biopharma platform is a substantial cornerstone of #FutureFresenius. Prolia® and Xgeva® are registered trademarks of Amgen Inc.

Fresenius has successfully completed the divestment of its stake in the hospital Clínica Ricardo Palma in Lima, Peru. The sale marks Fresenius’ exit from the Peruvian hospital market and is in line with the company’s announcement to divest certain assets as part of #FutureFresenius.

mAbxience, a Fresenius Kabi majority-owned group, and Teva Pharmaceuticals International have entered a licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications. The agreement covers global markets, including in Europe and the United States. Biosimilars show promising potential in providing more cost-effective alternatives to existing oncology therapies, thereby addressing a critical need in global oncology care. mAbxience will leverage its expertise and its state-of-the-art facilities in Spain and Argentina to develop and manufacture the biosimilar product. #FutureFresenius

Members of the Fresenius Management Board purchased Fresenius shares with a total value of around €1.3 million over the past days as stipulated under the current compensation system. This underlines the commitment of the Management Board to drive the Company’s transformation at full speed. Fresenius is making strong progress in the Re-Vitalize phase of its journey towards #FutureFresenius. In 2024, which is expected to be a year of financial progression, the Company is focusing on deleveraging and pacing cost savings in order to build further earnings growth momentum and unlock value.

Fresenius Kabi and Formycon announced today that they have reached a settlement agreement with Johnson & Johnson for FYB202, a proposed ustekinumab biosimilar to Stelara®* in Europe and Canada. The terms of the settlement are confidential. The agreement falls in line with Fresenius Kabi’s recent milestones in its Biopharma segment. The company has a track record of successful market entries in countries around the world. Fresenius Kabi’s consistently growing biosimilars portfolio is focused on oncology and immunology and set to bringing high-quality, affordable, and accessible treatment options to patients as well as healthcare providers in line with #FutureFresenius. * Stelara® is a registered trademark of Johnson & Johnson