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Fresenius today announced that its operating company, Fresenius Kabi, is now offering Epinephrine Injection, USP, in 30 mg per 30 mL multi-dose vials in the United States. Following the introduction of the first generic version of Epinephrine, USP, in a 1 mg per mL vial for U.S. customers in December 2024, the product launch expands Fresenius’ offerings of Epinephrine Injection. Epinephrine Injection 30 mg per 30 mL is a prescription medicine used for emergency treatment of allergic reactions (Type 1), including anaphylaxis, in adults and pediatric patients and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. In line with #FutureFresenius, Fresenius Kabi has invested more than $1 billion to expand and modernize advanced U.S. pharmaceutical production and distribution facilities. Epinephrine Injection is manufactured in the U.S., reflecting the company’s commitment to domestic production. More than 70% of the pharmaceuticals that Fresenius Kabi sells to U.S. customers are formulated, filled and packaged in the U.S.

Fresenius continues reducing complexity and optimizing utilization in the production network of its Operating Company Fresenius Kabi in line with its Vision 2026 and #FutureFresenius: Today, Fresenius Kabi and EMS have signed an agreement to transfer the ownership of Fresenius Kabi's production site in Anápolis, Brazil, to EMS. The multinational pharmaceutical company has a strong presence in Latin America and will take over the generic injectables production plant, the development center, and the warehouse as well as full staff and will continue production. The transaction is subject to customary closing conditions, including merger approval.

Fresenius has completed the divestment of Vamed’s international project business to Worldwide Hospitals Group (WWH), that was announced in February 2025. The divestment is part of Fresenius’ structured exit from its Investment Company Vamed and enables Fresenius to further increase focus and management capacity on the ongoing progress of its core businesses Fresenius Kabi and Fresenius Helios, in line with #FutureFresenius.

Fresenius today announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence®** (denosumab-bnht) and Bomyntra®** (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug Administration (FDA). The denosumab biosimilars are approved for all indications of the reference products Prolia®* (denosumab) and Xgeva®* (denosumab), respectively. Additionally, Fresenius’ operating company has reached a global settlement with Amgen, allowing the launch of these biosimilars in the US from mid-2025 and in Europe later end of November 2025 subject to regulatory approval. The FDA approval and the global settlement agreement with Amgen are the latest developments in Fresenius’ continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Growing the company's (Bio)Pharma platform is a substantial cornerstone of #FutureFresenius. *Prolia® and Xgeva®* are registered trademarks of Amgen Inc. **Conexxence® and **Bomyntra® are registered trademarks of Fresenius Kabi Deutschland in selected countries. Read the full press release here. Please click to see full Prescribing Information for Conexxence®. Please click to see full Prescribing Information for Bomyntra®.

Today, Fresenius published its 2024 Annual Report. As already announced in February, the healthcare group grew profitably in the past year and achieved its outlook, which was raised twice, through consistently good business performance. Group revenue before special items increased to €21.5 billion, with organic growth of 8%. Fresenius was also able to reduce net debt by €2 billion in 2024. “Our #FutureFresenius program, which we launched at the end of 2022, is having an impact. The “new” Fresenius is much more focused. We are concentrating on Fresenius Kabi and Fresenius Helios. These are growing profitably and under their own steam,” said Michael Sen, Chairman of the Management Board of Fresenius. “Growth, higher margins, more cash, lower debt – all this has created value: From the beginning of October 2022, when we prepared the ReSet, until February 28, 2025, the share price rose by 76%.” For the first time, the Annual Report includes a sustainability report in accordance with the European Sustainability Reporting Standards (ESRS). This replaces the Non-financial Report of previous Annual Reports and expands and supplements reporting topics and details. In addition, the ESRS report, like the financial report, is audited externally. The 2024 Annual Report is available in German and English as a PDF file and as an online version. Further publication and event dates for 2025: · 04/24/2025: Publication of Sustainability Highlights Magazine · 05/07/2025: Publication of the financial results for Q1 2025 · 05/23/2025: Annual General Meeting · 08/06/2025: Publication of the financial results for Q2 2025 · 11/05/2025: Publication of the financial results for Q3 2025

Fresenius announced today that its Operating Company Fresenius Kabi’s ustekinumab biosimilar Otulfi® (ustekinumab-aauz), developed by Formycon AG, is now available in the United States and European Union. Otulfi® is an ustekinumab biosimilar for the reference product Stelara® (ustekinumab). In February 2023, Fresenius Kabi and Formycon entered a global commercialization partnership for the ustekinumab biosimilar covering key global markets. In September 2024, U.S. FDA and EC approval for both subcutaneous and intravenous formulations was received. Otulfi® is indicated for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis in the U.S. Being Fresenius’ fourth biosimilar on the market, the company continues the growth path of its BioPharma platform in line with #FutureFresenius.

Fresenius, via its operating company Fresenius Kabi, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to its Adaptive Nomogram, an alternate algorithm that will be available in the Aurora Xi Plasmapheresis System. The Adaptive Nomogram enables an average 11.6% increase in plasma collection per donation while maintaining safe and effective operation. This enhanced capability will allow plasma centers to improve collection efficiency. Plasma-derived therapies are essential for treating a wide range of conditions, including immune deficiencies, bleeding disorders, and neurological diseases. By increasing plasma collection efficiency, Fresenius Kabi reinforces its commitment to improving access to these critical therapies. The clearance received for the Adaptive Nomogram is another milestone in line with #FutureFresenius.

Fresenius, through its operating company Fresenius Kabi, is broadening its growing biopharma portfolio through a new licensing agreement with South Korea’s SamChunDang Pharm (SCD). Under the agreement, Fresenius Kabi will exclusively commercialize SCD’s aflibercept biosimilar candidate in the U.S. and several countries in Latin America. Aflibercept is used to treat a range of ophthalmic disorders, including wet age-related macular degeneration. Under the agreement, Fresenius Kabi will commercialize the proposed aflibercept biosimilar, a vascular endothelial growth factor receptor (VEGFR) Fc fusion protein, in the US, Brazil, Argentina, Chile, Paraguay, Colombia, and Mexico after successful approval by respective health agencies. SCD is responsible for the development, manufacturing, and supply of the drug. Fresenius Kabi is an operating company of Fresenius that specializes in (bio)pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions. SCD is based in South Korea and specializes in developing generics and biosimilars for global markets. Aflibercept is a proposed biosimilar referencing Eylea®, an anti-VEGF for the treatment of ophthalmic conditions such as wet age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR). Eylea is commercialized by Regeneron in the US and by Bayer in other countries. “With the commercialization of the aflibercept biosimilar, we are broadening our product portfolio with a treatment option for ophthalmic diseases. In alignment with our #FutureFresenius strategy, this marks another significant milestone for Fresenius Kabi in fulfilling our strategic objective of enhancing access to biosimilars for patients globally,” said Dr. Sang-Jin Pak, Fresenius Kabi’s President of Business Unit Biopharma. "We are thrilled to have finalized this agreement and are eager to move forward with the commercialization of our aflibercept biosimilar candidate upon approval. The combination of SCD’s specialized expertise in ophthalmology and Fresenius Kabi’s global commercial strength creates a robust foundation to support our shared objective of improving patient access to more affordable treatment options in ophthalmology," says Mr. Chun In Seok, Chief Executive Officer at SCD. *Eylea® is a registered trademark of Regeneron.

Fresenius, through its operating company Fresenius Kabi, announced today that Epinephrine Injection, USP, is now available in the United States as the first generic version of Epinephrine in a 1mg/1mL vial for U.S. customers. Epinephrine Injection, USP is a prescription medicine used to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock; for emergency treatment of allergic reactions including anaphylaxis and for induction and maintenance of mydriasis during intraocular surgery. In line with #FutureFresenius, Fresenius Kabi has invested more than $1 billion in recent years to expand and update its U.S. pharmaceutical production as well as distribution facilities. More than 70 percent of the product units shipped in the U.S. by Fresenius Kabi are drugs listed on the FDA’s Essential Medicines List.

Fresenius, via its operating company Fresenius Kabi, and Ori Biotech, a leader in cell and gene therapy (CGT) manufacturing technology, have entered an agreement to provide the integration of the IRO® platform with Fresenius Kabi’s upstream and downstream processing technologies. The successful integration of these leading technology platforms provides a streamlined, closed workflow for cell therapy manufacturing that can reduce process steps, tube- and bag-based transfers, and operator touch time. This collaboration underscores Ori Biotech and Fresenius Kabi’s shared commitment to driving innovation and developing widespread patient access to life-saving cell and gene therapies. All to help bring cell and gene therapies to market faster and more efficiently, in line with #FutureFresenius.

mAbxience, a Fresenius Kabi majority-owned group, and Egis have entered a strategic commercialization agreement for two biosimilar candidates in key Central and Eastern European markets. Fresenius Kabi, an operating company of Fresenius, continues to reinforce its biopharma business and strategic network through this new agreement with Egis. This directly underscores the mutual commitment of both companies to broadening access to essential, high-quality biosimilar therapies in markets where affordability and accessibility are critical. The agreement strengthens Fresenius Kabi’s presence in Central and Eastern Europe and reaffirms its dedication to drive innovation and accessibility of life-saving treatments in global healthcare, all in line with #FutureFresenius.

Fresenius, via its operating company Fresenius Kabi, and Cellular Origins, a TTP Company, have entered an agreement to develop integration strategies for Fresenius Kabi’s portfolio of Cell Therapy Technologies within Cellular Origins’ Constellation™ automation platform. The agreement aims to leverage each company’s expertise in cell and gene therapies (CGTs) for digitally and physically integrating Fresenius Kabi’s suite of cell therapy processing technologies within Cellular Origins’ CGT robotic manufacturing platform Constellation™. Initial focus will be on integration of the Cue® Cell Processing System for automated small volume processing. Driving innovation by building momentum in cell and gene therapy, is a further milestone of #FutureFresenius.