ESRS S-Company-specific Innovation[S-Company-specific]

Impacts, risks, and opportunities [SBM-3] Material impacts, risks, and opportunities and their interaction with strategy and business model

Impacts, risks, and opportunities

Within the scope of the materiality analysis, Fresenius has identified the following opportunity related to Innovation:

Approach [MDR-P] Policies adopted to manage material sustainability matters

Policies: focus areas and quality requirements for innovation

Fresenius pursues an integrated approach to innovation. The effectiveness of the processes defined with the innovative approaches as well as controls are subject to the respective specialist department or Operating Company in which the approach was developed. Innovations take place along the value chain on key topics and contribute within own operations to the following topics:

• Improved safety of products and services (see topical standard S4: Consumers and end-users, section Health and safety)

• Improved access to healthcare (see topical standard S4 Consumer and end-users, section Access to products and services)

• Improving treatment options and patient experience through research, telemedicine, and artificial intelligence (AI) (see S-Digital transformation)

• Improved environmental performance through the integration of sustainability aspects into products or processes, e.g., enhanced building climate control or sustainable product development (see topical standards E1 Climate change and E5 Resource use and circular economy).

In these areas, the company is striving for innovations in existing products and care provisions as well as in the development of new therapeutic approaches. Accordingly, you will find details on the respective Group or Operating Company approaches, the associated policies and targets, as well as operational activities and, where applicable, measures in the referenced topical standards. The following section outlines the overarching approach from a Group perspective and highlights strategic elements.

Fresenius takes into account the interests of its stakeholders in the value chain, as stated in the standard ESRS 2 General disclosures or in the referenced topical standards, and selects approaches tailored to market situations and Operating Companies – from independent strategies for research and development (R & D) to active innovation management. External partners, such as research institutions and start-up companies are also involved in this process. Fresenius also wants to meet increasing requirements, particularly driven by regulation, with regard to transparency in the care of critically ill patients, like increased information demand, among other elements.

For this target group, effective therapies in combination with intelligent applications and medical engineering devices, among other things, will continue to be in greater demand in the future – and require suitable product innovations. Last but not least, Fresenius is also working on innovative solutions in registration studies and clinical research projects to create opportunities to improve the quality of treatments.

AI is playing a transformative role in the development and delivery of healthcare solutions. In 2025, Fresenius introduced a new AI governance policy establishing a group-wide framework for the safe and ethical use of AI across the Fresenius Group. For more information on this policy, please refer to S-Digital transformation.

In the defined focus areas, based on the defined markets in which Fresenius is active, and further explained in ESRS 2 standard General disclosures, and the business strategy (Combined Management Report, section The Group’s business model), Fresenius complies with internal quality requirements as well as external regulations and legal requirements for all new or improved products and services. In the field of medical technology, e.g., European directives such as the EU Medical Device Regulation (MDR) apply. For the development and use of AI applications, Fresenius follows the EU Regulation on Artificial Intelligence (Regulation (EU) 2024 / 1689; in short: AI Act), which came into force in August 2024. For digital developments, also the requirements of the European Union’s General Data Protection Regulation (EU GDPR) are observed.

Fresenius uses comprehensive cybersecurity concepts to counter potential risks, such as hacker attacks on sensitive data and systems. Further information can be found in topical standard S4 Consumers and end-users, Privacy section and in the company-specific standard G-Cybersecurity.

Group management of innovation

Innovation is defined as a key topic of the overarching Group strategy. The respective business area strategy is specified by the Operating Companies with the support of functions at Group headquarters. This strategy is used to determine the areas in which innovation can be meaningfully carried out in the long-term in order to make the best possible use of potential for improved healthcare services and products. On the Management Board, the CEO is responsible for the Group’s overall strategy. Operational implementation takes place within the Operating Companies and their businesses. It is anchored in the local organizations and managed by the respective management functions. Responsibility for innovation and R & D is regulated, e.g. via a business allocation plan.

An expert from the Group function reports to the Chief Executive Officer on a daily basis and is also in contact with the entire Management Board through various internal committees. The managers of the Corporate Development function and the specialist managers of the Operating Companies exchange information as required and on an ad hoc basis. As part of the Management Board meetings, the Management Board is informed monthly of relevant developments from the Operating Companies. Information on the Supervisory Board and related procedures for material sustainability aspects are explained in standard ESRS 2 General disclosures.

The Chief Medical Officer as part of the Corporate Development Group function, is responsible for the strategic framework within which innovation takes place globally. The role of Chief Medical Officer is intended to position Fresenius as a leading healthcare company among medical and scientific decision makers. He also advises the Management Board and Operating Companies on medical aspects as well as conceives and implements his own projects. In the reporting year, this included, e.g., implementation projects in the field of cell therapies.

The Innovation Council is responsible for Group-wide innovation projects. The committee has developed an innovation roadmap with a focus on three strategic areas: (Bio)pharmaceuticals, MedTech and Care Delivery. The council comprises representatives from the Operating Companies, as well as the Group Strategy and M & A department. Together, these representatives evaluate and prioritize investment opportunities and drive key development and innovation projects forward within the Group. During the reporting year, the focus was on a feasibility study on advanced devices required in manufacturing of cell therapies.

In 2025, the Innovation Council evaluated specific innovation and digitalization projects across all segments and provided financial support to a small extent.

Projects are included in the sustainability reporting when they reach an appropriate level of maturity, which is assessed on the basis of the following aspects:

• applicability in operational business,

• supporting revenue and earnings targets, and

• contribution to a material aspect of sustainability, provided that the requirements of the ESRS are met as a material activity.

If the funded projects are at an early stage, they are not yet classified as individually presented information contributing to the Group’s sustainability performance. Further reporting on the priorities in innovation of the Operating Companies in general is provided in the Combined Management Report and in the following sections of this company-specific standard.

Product innovations

The Operating Company Fresenius Kabi is working on expanding the product portfolio, e.g., biopharmaceuticals, clinical nutrition, and MedTech, as well as IV (intravenous) generics. Innovation is defined as new substances, devices, software, packaging, or services to be introduced on the market, further development of product formulations or reformulation of existing substances for a new market, and new product formulations (e.g. the product Fresubin PLANT-BASED Drink), as well as the registration and launch of established products in new countries. Fresenius Kabi consistently applies for patents for innovative products and processes. The Operating Company currently holds 1,124 active and published patent families and pursues or holds them in a number of countries in line with sales activities.

Fresenius also includes ecological criteria in its approaches to product innovation. For example, the company uses life cycle assessments for various products in order to understand their environmental impact and continuously improve them on this basis. Further information on this can be found in the topical standard E5 Resource use and circular economy.

In 2024, Fresenius set new trends in cell and gene therapy through its Operating Company Fresenius Kabi and continued these efforts in the reporting year. An agreement was reached with Cellular Origins, a The Technology Partnership (TTP) company, to develop strategies for integrating cell therapy technologies into the Constellation™ automation platform of Cellular Origins. Through this collaboration, the two companies will combine their expertise in the digital and physical integration of cell therapy processing technologies. Initially, they focus on the Cue® cell processing system for automated small-volume processing. This project represents another important step for Fresenius Kabi in promoting innovation within the Group.

Further information can be found in the Fresenius Kabi Research and Development section of the Combined Management Report.

Treatment concepts, health services research, and clinical studies

Innovative treatment concepts are essential for daily work in clinics. The combination of clinical studies and knowledge gained through daily routines provides information on how established treatment schemes can be changed. These options are discussed with experts both from the medical departments and from care. At Fresenius Helios, the focus in terms of innovation is on clinical studies. Comprehensive clinical studies also form the basis for evaluating the effectiveness and safety of innovative solutions. In acute care hospitals, the main focus is on cardiovascular diseases and oncology as well as health services research.

Fresenius conducts clinical trials at many sites, e.g., to determine how effective and safe experimental medicines are and whether medical products are suitable for approval in accordance with internationally applicable ethical and scientific standards. In addition, clinical data is collected, analyzed, and published to improve patient care, optimize care processes, participate in the development of new tools to improve diagnosis, contribute to scientific and medical progress, and evaluate new and already-approved technologies and treatments in everyday care. Based on a clear commitment to evidence-based medicine, the company encourages its employees to engage in scientific and technological research activities.

The aim is for them to grow personally and use their insights to improve the well-being of patients. Patients who agree to participate in a study are closely monitored by qualified medical staff. They also have the opportunity to provide feedback on the process and treatment during regular checkups and consultations. They also have access to all reporting channels available to other patients within Fresenius’ facilities.

The study sponsor is obligated to report and document any irregularities or side effects that occur during the study. In the case of externally commissioned clinical trials, the sponsor is usually the pharmaceutical company that commissioned the trial. For certain clinical trials commissioned by a sponsor, the contract may include a clause committing the sponsor to continue providing the investigational drug to participating patients. This ensures that participants can continue receiving the treatment that has proven beneficial for them in the event of a positive study outcome.

In Germany, the Helios Health Institute (HHI) has been established as a specialized unit for preparation and monitoring of studies. It is responsible for the central study approval for hospitals of Helios in Germany and ensures that all regulatory requirements applicable to research activities, including contractual or data protection requirements, are met as part of the study review. With the final legal, regulatory, and data protection assessment, a recommendation for the medical research project is made to the applicant and the management of Helios clinic.

The Helios Group regulation on research funding specifies the framework conditions within which Helios specifically promotes research projects that are conducted by its own employees and expected to have a high level of benefit for patients.

Departments or clinics have special certifications, e.g., as certified organ cancer centers or as oncology centers of the German Cancer Society. Certification is based on factors such as the quality of treatments or sufficient participation of patients in clinical trials. If an external sponsor selects a Helios clinic for a study, audits are conducted in accordance with the sponsor’s respective guidelines. Likewise, individual Helios clinics in Germany are inspected according to the respective selection procedures for gaining a license as a specialized center of the state authorities.

At Fresenius Helios in Spain, hospitals that form part of the public health network in Madrid are managed through the Instituto de Investigación Sanitaria Fundación Jiménez Díaz (IIS-FJD).

For the other hospitals, research is managed by the Corporate Research and Innovation department with the support of the Research Support Units located in the different hospitals and regions. The department promotes and supports research activities in the hospitals of the Fresenius Helios network in Spain and in the Research Support Units, while establishing the necessary guidelines to ensure that research activities are carried out in accordance with the highest standards and in compliance with all legal and regulatory requirements and best practices in the sector.

In Spain, an updated certification is required for all researchers and teams to conduct a clinical trial. To select a clinic for a study, the sponsor initially audits the infrastructure to ensure compliance with the specific requirements to conduct the clinical trial. As in the case of Helios clinics, if a sponsor selects a Helios Spain clinic, audits are also conducted in accordance with their respective guidelines. Additionally, Fresenius Helios in Spain has developed the prime investigators program, a procedure to select investigators of excellence in the clinical trial environment. The program includes a list of top investigators with accredited experiences in clinical trials which is shared with project sponsors to provide visibility to our investigators.

Monitoring is ensured by audits as well as inspections by state, higher, and regulatory authorities. In case of complaints, appropriate corrective actions are initiated by the respective clinic and reported to the inspecting authority. In 2025, the HHI was certified by TÜV Nord according to ISO 9001:2015. No other external inspections or audits took place.

Throughout the Group, clinical studies are always carried out in accordance with strict legal requirements and international guidelines and frameworks. These include, among other items, the guidelines from the International Council of Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP), requirements of relevant pharmaceutical regulatory authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), as well as the Declaration of Helsinki, and the EU GDPR (see topical standard S4 Consumers and end-users, Privacy section). The primary goal is the protection of patients and ensuring the high quality of the data obtained.

Approval studies for products, e.g., are only conducted in countries or facilities that have the necessary medical and professional expertise to manage the relevant therapeutic area.

The management of new innovation initiatives should be further channeled and improved. For that, a transparent repository of innovation proposals with a traceability register is established. The proposals registered in this repository are evaluated by a committee of experts who assess their viability and prioritize them according to their interest.

Actions [MDR-A] Actions and resources in relation to material sustainability matters

In August 2025, Fresenius announced a collaboration with other companies and academic institutions from eight countries with the goals of accelerating the manufacturing of CAR-T cell therapy, making it more cost-effective, and improving patient access across Europe. Led by Fresenius, the newly launched EASYGEN (Easy workflow integration for gene therapy) consortium will focus on efforts to develop a modular, hospital-based platform capable of manufacturing personalized cell therapies in just a few days, rather than weeks. The project is a public-private partnership, with €8 million in funding provided by the EU through the Innovative Health Initiative (IHI). It leverages technology originally developed by the Cell and Gene Therapy team of Fresenius Kabi, part of Fresenius. The project ends in 2030.

Fresenius receives subsidies of around €1.3 million. Further administrative costs (OpEx) are not budgeted separately. They relate to personnel expenses, for example for the lead of the consortium, within the Group function Corporate Development.

Fresenius is actively involved in cell and gene therapy. Fresenius Kabi provides medical technology for these therapies, including automated cell processing systems such as Lovo and Cue. Fresenius Helios, for example, at its German Helios Hospital Berlin-Buch, has been offering CAR-T cell therapy as a standard treatment for relapsed cases since 2019. The clinic is also conducting clinical trials to further explore the potential of CAR-T therapies. In Fresenius Helios Spanish hospital business, the company has established specialized oncology units that offer CAR-T cell therapy as part of their advanced cancer treatment portfolio, particularly for hematologic malignancies.

At the Bad Homburg site, Fresenius used existing infrastructure to build an innovation center for Fresenius Kabi. The move to the new building is planned for mid-2026.

Once completed, the new building will be used by Kabi’s Nutrition business unit, primarily by the Research & Development Enteral Nutrition department, but also by the Compounding Devices department.

The global product development team is working on the further evolution of the enteral nutrition product portfolio. Specifically, the team has developed a vegan Fresubin sip feed based on soy protein, for example. Product development is now working on a plant-based tube feed, among other things. With the rise in metabolic disorders and chronic diseases such as diabetes, the global demand for special clinical nutrition is expected to increase significantly in the coming years. Since 2014, the Compounding Device unit has mainly been working on the development, production, and marketing of KabiHelp Pro, a compounding device for the production of patient-specific parenteral nutrition. The global rollout of KabiHelp Pro is currently in full swing and is intended to help secure and expand Kabi’s global market leadership in the field of parenteral nutrition.

The KabiLab fulfills sustainability criteria: Parts of the existing building fabric and technical infrastructure will be used, which will significantly reduce CO₂ emissions compared to a completely new building. In the future, photovoltaic panels will supply green electricity, an efficient heat pump will be used to heat the rooms, and rainwater will be stored to irrigate the new green spaces.

Overall construction budget is more than €16 million, which primarily relates to capital expenditure. The building will be consolidated in the balance sheet as property, plant and equipment.

Goals and ambitions [MDR-T] Tracking effectiveness of policies and actions through targets

In the daily dealings with patients and healthcare professionals, the Group is confronted with questions that arise from the use of products and devices or therapies. This feedback is incorporated into the work on innovations and can thus contribute to solving challenges in the healthcare sector. Fresenius therefore strives to maintain and continuously improve these communication channels for feedback. Moreover, successful clinical studies are the basis of products and services because they guarantee safety and effectiveness. They simultaneously drive development and implementation of innovative technologies and treatment concepts. One goal of Fresenius is to keep adding value for customers and patients in the long-term and, e.g., to improve treatment quality as outlined in the topical standard S4 Consumers and end-users.

Fresenius is continuously working to expand its competencies and develop new business areas. The area of digital solutions is no exception. Fresenius’ aim is to develop innovative therapies and solutions for integrated healthcare services, since many stakeholders, especially patients and employees, are directly affected by the changes resulting from the advance of digitalization (see also the company-specific standard Digital transformation). R & D activities are closely linked to digitalization and are an integral part of the growth strategy. However, Fresenius does not conduct fundamental research.

Metrics [MDR-M] Metrics in relation to material sustainability matters

Number of studies and product approvals

In 2025, a total of 1,491 studies (2024: 1,436) were conducted or reviewed in Spain, the majority of which had the goal of improving therapies for patients. The focus was on oncology, hematology, and neurology.

In Germany, 157 study applications were evaluated in the reporting year. The metric includes the number of research applications from Fresenius Helios in Germany that were reviewed in the reporting year. The majority of applications that received a positive assessment were approved for implementation by the clinics.

In pharmaceutical products, Fresenius was also able to launch various new products on the market or introduced improvements in application and additional dosage forms. Further information can be found in the Fresenius Kabi Research and Development section of the Combined Management Report.

At Fresenius Helios in Spain, the research and innovation team monitors the number of clinical studies using a central platform. The amount of funding for clinical research activities results from the projects financed by the EU.

Product approval processes in the pharmaceutical industry are clearly defined by regulatory provisions. Management and controls are documented in the respective company’s internal global SOPs. A detailed description of the methodology of the regulatory process is omitted.