Consumers and End-Users (S4)

Ensuring patient health and safety is our top priority. From clinical trials to post-market surveillance, we aim to ensure that our medicinal products are effective in combatting disease while posing the lowest possible risk to patients. At the same time, we recognize that access to healthcare remains unequal. Our strong commitment to health equity includes holistically combining innovation, equitable access and active community engagement to ensure that all individuals – regardless of their geographical, social and economic background – can benefit from our healthcare solutions. This chapter is divided into two subchapters: Health and safety of our patients as well as access to our products and services and access to (quality) information. They describe how we safeguard patient well-being, promote equitable access to healthcare solutions and help patients make informed decisions about our medicinal products.

Definition of consumers and end-users

Our materiality analysis included identifying impacts, risks and opportunities related to consumers and end-users. All consumers and end-users who are likely to be materially impacted by our company were taken into account when describing our strategy and business model. All impacts, risks and opportunities related to consumers and end-users that exceed our materiality threshold are attributable to our Healthcare business sector.

Our Healthcare business sector’s consumers are primarily individuals who acquire, consume, use, or are intended to use our medicinal products and services, such as patients, their relatives or carers. Our primary end-users are adult and pediatric patients who use or are intended to ultimately use our medicinal products and services. End-users also include clinical trial participants (patients or healthy volunteers participating in clinical trials).

Furthermore, our end-users include those who benefit from the information and services we offer, such as people who are made aware of diseases through campaigns and/or who make use of our diagnostic or screening services. The same applies to students or researchers who take part in initiatives to foster health skills in science. Our end-users are particularly vulnerable to health impacts as they are primarily patients or people with medical needs. Medicinal products offer benefits to patients, yet may also pose risks. Consequently, our products may result in some end-users experiencing adverse effects and/or facing an increased risk of undesirable conditions/diseases. Consumers and end-users of our products depend on accurate and accessible product- or service-related information – such as manuals, product labels or package inserts – for healthcare professionals or for themselves to use the product correctly and ultimately obtain the intended effects and minimize adverse effects. In addition, our end-users may also include particularly vulnerable populations, such as children or people who are financially disadvantaged.

Moreover, the range of therapeutic areas in which we aim to improve healthcare and the nature of our business model result in our treatments being provided to consumers and end-users who may be at greater risk of harm due to particular characteristics. Examples of such end-user groups include:

• End-users participating in clinical trials for innovative treatments for severe diseases who may be exposed to risk of harm due to the less-well-characterized efficacy and safety profile of the treatment solutions under investigation.

• Oncology patients who are exposed to cancer drugs that can have inherently harmful effects (adverse effects) due to their mode of action. However, patients being treated for a life-threatening disease like cancer may accept such risk if the treatment is beneficial in combatting the disease.

• Pediatric patients (such as those receiving medicinal products for the treatment of schistosomiasis) are vulnerable end-users.

Our material impacts, risks and opportunities in relation to consumers and end-users (S4 SBM-3)

Patient health and safety

Our strategy to improve patient health

As a science and technology company, we are committed to advancing healthcare and to improving patient health by using our innovations to deliver first-in-class or best-in-class medicinal products that pose the lowest possible risk. The safety of patients treated with our medicinal products is our top priority. We continuously aim to adapt our strategy to address material impacts.

Our focus on innovative solutions and transformative technologies aligns with our strategy to address high unmet medical needs across all our therapeutic areas, thereby driving our organic growth. In addition, we continuously evaluate our R&D pipeline to prioritize investments in areas that best meet patient needs and to focus in particular on complex or rare chronic conditions. Communicating effectively and monitoring our products post launch enable us to mitigate risks associated with adverse effects, underscoring our commitment to patient safety throughout the product life cycle. Our portfolio includes the therapeutic areas of oncology, rare diseases, neurology and immunology, fertility as well as diabetes, cardiovascular diseases, metabolic disorders, and endocrinology. Fundamental Information about the Group contains more details about our healthcare product portfolio. It can be found in the Management Report under Company Profile and Structure/Healthcare.

Clinical trials

Obtaining regulatory approval for our medicinal products involves conducting clinical trials with patients and, if necessary, also with healthy volunteers to investigate the safety and efficacy of our medicinal products. We aim to do so only in countries where we intend to market our medicinal products to ensure accessibility to them after successful market authorization. Clinical trials, which typically involve hundreds of participants, enable us to investigate and provide new treatments to patients, including those living in low- and middle-income countries. Clinical trials may also have a positive impact on participants, who receive potentially life-saving medicinal products in a controlled setting and prior to commercial availability. Before deciding whether to continue developing a medicinal product, we carefully and thoroughly assess all available data to ensure that its potential benefits for patients outweigh its potential risks.

If a medicinal product demonstrates a favorable benefit-to-risk ratio in clinical trials and receives regulatory approval, we launch it commercially. We aim to ensure the safe use of our products on the market by continuously reviewing and assessing safety data updates on them.

In the event that drug candidates fall short of expectations, we set up financial provisions for costs necessary to meet our obligations to trial participants (connected to IRO S4-R-02). As of December 31, 2025, provisions for follow-on obligations in connection with discontinued clinical development programs in the amount of € 80 million are accounted for. Of this amount, € 45 million are additions in fiscal 2025 and payments totaling € 43 million were made, as well as reversals totaling € 69 million. More information can be found under Note (27) Other provisions in the Notes to the Consolidated Financial Statement. Furthermore, impairment losses on intangible assets in the amount of € 223 million were recognized in fiscal 2025 in connection with discontinued development projects in the Healthcare business sector. The further financial consequences of this risk on the next reporting period cannot be estimated at this time.

Ethical and scientific principles

We have established strict company requirements and compliance guidelines to ensure that we conduct clinical trials ethically. The safety, well-being, dignity, and rights of the sick and healthy participants in our clinical trials are our top priority. We ensure patient safety during clinical trials by selecting participants based on eligibility criteria considering known risk factors, such as age and comorbidities. Notably, we only enroll the precise number of patients required to answer the scientific and medical questions posed. Our clinical trials always address issues that are relevant to improving the healthcare that patients receive. We only conduct them if our established methodology indicates that the medicinal product being developed is likely to demonstrate significant therapeutic promise and a positive benefit-to-risk ratio.

Special protection for specific patient groups

We are committed to conducting clinical trials that adequately represent the diverse patient populations that are likely to use our medicinal products after regulatory approval. This ensures that we assess the safety and efficacy of our medicinal products across different patient populations. We achieve this by enrolling a diverse range of participants. Participants vary by a number of factors, including but not limited to age, sex and gender identification, ethnicity, race, religion, socioeconomic background, and disability. A written statement of our commitment to diversity in our trials can be found on our website. In addition, each clinical trial has specific inclusion and exclusion criteria to ensure that only participants likely to benefit from the treatment are selected. This enables us to increase the likelihood that our clinical trials ultimately have a positive impact on the patients and communities who need the medicinal products being tested.

Clinical trials that involve participants from vulnerable populations must be conducted with particular care to ensure compliance with the highest ethical and scientific standards. We therefore only conduct studies involving such populations if scientifically justified and if there is no alternative approach to achieving conclusive results.

Integrating patient perspectives

We are committed to patient-focused drug development that actively involves patients, carers and their representatives. Their valuable perspectives and insights into disease and treatment management help us make more informed decisions at every stage of drug development. S4-2 provides more information.

Governance and compliance in clinical trials

We audit the processes and procedures of our clinical trials on a regular basis to verify their compliance with applicable laws and guidelines. Regulatory agencies also perform inspections for external verification. In addition, we review the safety reports across the entire product life cycle and immediately address any unforeseen risks as applicable. Senior boards, such as our Medical Safety and Ethics Board, oversee emerging safety concerns. In addition, cross-functional teams assess the benefit-risk ratio of each medicinal product and its development strategy, seeking to properly characterize and mitigate risks for our consumers and end-users while increasing the likelihood that the medicinal products will have a beneficial effect.

Early access programs

Our early access programs make some of our investigational medicinal products available for treatment prior to the approval of health authorities. We strictly control access to these programs to ensure the safety and well-being of patients. Patients treated with such products must have a serious or life-threatening disease or condition, have exhausted all other treatment options and be unable to participate in a clinical trial. Moreover, clinical data must sufficiently indicate a reasonable expectation that the patient can have a clinically meaningful benefit and that the medicinal product has an acceptable safety profile for the patient. Internal audit procedures ensure compliance with our standard governing this type of access.

Approved medication for unapproved uses

Additionally, we receive unsolicited requests from physicians to provide access to approved medicinal products for unapproved use, free of charge. We strictly control access to ensure patient safety and well-being. The same conditions regarding patient status and benefit-risk profiles apply as described for the early access programs.

Post marketing

Once the medicinal products receive regulatory approval and enter the downstream value chain, we collaborate with wholesalers and/or distributors as well as pharmacies in the respective countries to deliver our medicinal products. Pharmacies also help to ensure correct and responsible product use. Our medicinal products can be obtained with a prescription to ensure that their use is safe and medically justified. Where applicable, we support patients and end-users by providing educational materials and guidance on safe administration. We periodically hold Patient Advisory Board meetings to learn more about our patients’ perspective. These meetings focus on patient-facing materials, disease journeys, and support programs. S4-2 and S4-3 describe the various ways in which we engage with patients. We also work closely with healthcare professionals and organize Medical Advisory Boards to gain insights from their treatment experience. Their feedback informs our business strategy, including drug development and the design of patient-support programs aimed at improving care.

Ongoing product safety monitoring

As stated in our Code of Conduct, the safety of patients treated with our medicinal products is our top priority. We strive to continuously monitor any treatment-related risks or adverse effects and take the necessary action to minimize them in order to safeguard the interests and the rights of our consumers and end-users of our medicinal products. We have established a pharmacovigilance system in accordance with our legal obligations and international guidelines to ensure that we monitor adverse effects, including those not detected during clinical development. This enables us to identify and communicate them transparently, thereby reducing risks for patients. Our pharmacovigilance encompasses the entire life cycle of a medicinal product: development, market launch, clinical use, and, in some cases, expiration or revocation of regulatory approval.

Our policies related to consumers and end-users (S4-1)

Our human rights commitment

We are committed to respecting the human rights of consumers and end-users in line with the UN Guiding Principles on Business and Human Rights (UNGP), and we expect our employees and our business partners to do so as well. Specific company documents outline the relevant management processes and actions for particular human rights issues such as research ethics, including clinical studies. However, we currently do not explicitly monitor compliance with human-rights-related processes and actions with regards to consumers and end-users. Our commitment to human rights is further reflected in our long-standing participation in the UN Global Compact, which we joined in 2005. We endeavor to prevent the risk of human rights violations to the greatest degree possible, not only at our own sites but also along our entire value chain. More information can be found under Our policies related to consumers and end-users.

We have also adopted a Supplier Code of Conduct, which applies to all providers of goods and/or services to our company (suppliers) and sales intermediates (such as dealers, distributors, wholesalers, agents, and resellers). It defines minimum standards, which suppliers agree to meet, for respecting human and labor rights, occupational health and safety, business integrity, environmental protection, continuous improvement, and supplier management. More information can be found under S2.

We have a Group-wide whistleblowing and complaints system that enables any stakeholder to report – anonymously and free of charge – potential human rights violations or product-related risks. The WHO Patient Safety Rights Charter (2024) considers patient safety to be an important application of human rights norms and standards in healthcare settings. For example, patients have the right to receive safe medication, to be heard when they experience adverse effects related to the use of our products, and to obtain timely, accurate and complete information about how to use our products safely. Our product complaints channel and our pharmacovigilance system address these rights of patients and end-users. If new safety risks are identified, we immediately inform health authorities and relevant stakeholders and take corrective action, including product recalls where necessary. Our complaints system is general and is not limited to cases relating to consumers and end-users. Violations of our Code of Conduct or legal provisions as well as human rights and environmental concerns during clinical studies can be reported via our Group-wide whistleblowing and complaints system.No severe human rights issues or incidents connected to consumers and end-users were reported in 2025.

If our safety risk assessments identify any new safety issues, if safety observations in the downstream value chain require urgent safety measures or if we identify new safety information that could impact the benefit-risk profile of our medicinal products (for example, in the event of a product recall as part of crisis management), we immediately notify the health authorities using the appropriate emergency response procedures. Emergency response procedures include seeking health authority approval for further actions and communicating the information to relevant healthcare professionals. In addition, we promptly share this information with our business partners and clinical trial investigators, enabling them to take proper action where the medicinal product in question is used. More information can be found under Our complaint handling mechanisms.

Our processes for engaging with consumers and end-users (S4-2; S4-3)

We aim to continuously improve our research and development approach and are committed to patient-focused drug development. We actively engage with patients, carers and their representatives as well as patient experts and patient advocacy groups – throughout the drug development process as well as after drugs become available on the market – to understand their needs. Their valuable insights into disease and treatment management help us make more informed decisions that benefit the patients throughout a medicinal product’s life cycle. Our compliance guidelines define how we aim to ensure that our engagement activities take place within an ethical framework. The phases in which we engage with consumers and end-users, as well as the type and frequency of engagement vary by process. We generally work with consumers and end-users or their representatives either directly and/or through credible proxies. We issue press releases that provide updates on development milestones in order to transparently disclose new achievements that have the potential to change the treatment patients receive.

Patient Advisory Boards

Patient Advisory Boards (PAB) are a key source of insights from patients and carers. PABs draw from interviews, consulting agreements, surveys, and qualitative and quantitative research projects involving consumers and end-users. We collect feedback on specific conditions and on the experience of living with diseases. Insights from PABs guide decisions across our Medical, Clinical, Clinical Operations, Digital Health, and Communications functions. They also shape patient-support programs, digital tools, awareness campaigns, company strategies, and the development of patient-facing materials to ensure clarity and understanding. In addition, early input from PABs informs protocol development and execution to help make our clinical trials even more patient-centric. Responsibility for PABs lies with Clinical and Medical functions as well as with Government and Public Affairs. All PAB-related activities follow the guidelines of the European Federation of Pharmaceutical Industries and Associations and our policy, Good Practice and Process Guidance: Engagement with Patients, Patient Opinion Leaders, Carers, Patient and Carer-led Organizations.

Patient 360 program

Our annual Patient 360 summit and our Patient 360 projects enable us to collaborate with suitable patients, carers and patient organizations to find solutions for identified gaps or medical needs. We consult with them by means of e-mail and virtual or in-person meetings. After an advisory board session, we typically conduct a survey to gather feedback and assess the process. We summarize the insights, including concrete recommendations for action, in a report that we share with participants of the session and with relevant internal functions that may benefit from it. Valuable insights gained through the program have, for example, helped us plan and validate patient-engagement initiatives, identify gaps in support for carers of individuals with multiple sclerosis and myasthenia gravis, and co-create a website that provides information to patients and carers. The Director of Global Patient Insights & Advocacy for Neurology & Immunology and the Vice President for Global Patient Insights & Advocacy share responsibility for the Patient 360 program.

Medical Advisory Board

Our Medical Advisory Board serves as a forum in which external healthcare professionals can meet with our business sector’s medical employees to discuss unmet medical needs or evidence gaps. The board, which meets on an ad hoc basis, also enables us to obtain direct feedback from treating physicians. In 2025, the board convened 26 times. We supplement this with patients’ feedback on their treatment experience and patient-reported outcomes. We draw on this information to plan our clinical studies. For example, information might lead us to exercise greater caution when enrolling for trials in a particular country in order to prevent bias, to adjust treatments and patient populations, or to modify biomarker strategies to enhance the value of clinical data and improve patient stratification. Our aim is to deliver higher quality work in meeting patients’ needs during drug development, increase the benefits of drugs, and minimize the risks for participants in clinical studies. The accountability for the Medical Advisory Board meetings lies with the Medical function Heads.

Patient Data Collection System

We run a variety of programs to actively communicate with consumers and end-users of the medicinal products we have in the market. The programs may engage with patients, relatives, carers, and healthcare professionals as well as vulnerable groups, such as children, seniors, and pregnant or breastfeeding patients. Other forms of engagement include market research, digital health monitoring tools, patient support programs, and patient hotlines. Such programs or forms of engagement in which we gather feedback about our medicinal products from consumers or end-users constitute our Patient Data Collection System (PDCS). We use the system to collect information about adverse events raised or other concerns regarding a medicinal product’s safety and efficacy. A PDCS undergoes a certification process to ensure consistent safety practices across all qualified programs. The Head of Global Patient Safety unit oversees the PDCS process.

Individual Case Safety Report Management

Our Individual Case Safety Report Management gives consumers, end-users and healthcare professionals several channels to report adverse events. These channels include e-mail, fax, telephone, webpages, and various programs. Our Healthcare business sector provides employees with basic pharmacovigilance training to enable them to collect and report information on adverse events from all sources. Employees who work in programs or tasks related to patient safety receive additional role-specific training. We have established appropriate procedures for supplier management, the management of pharmacovigilance agreements with our business partners and conduct of audits. The adverse event data we collect inform the outcome of our safety evaluation as well as our decision-making. Individual Case Safety Report Management is overseen by the Head of Global Patient Safety unit and follows the Guideline on Good Pharmacovigilance Practices (GVP), Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products.

Post-Authorization Safety Studies

Once a medicinal product has been approved by the regulatory authority, the authority may request a study to collect further safety data. These Post-Authorization Safety Studies (PASS) create a mechanism by which we can collect safety data recorded or reported by healthcare professionals. The frequency of engagement to healthcare professionals varies depending on the program structure and requirements. Our Pharmacovigilance Advisory Board is involved in the review and endorsement of each PASS. Once approved and initiated, these clinical studies are then tracked in accordance with Good Pharmacovigilance Practices guidelines. Our collection of data through PASS also considers the vulnerable patient groups mentioned in previous paragraphs. PASS findings are published in the catalogues of Real-World Data Sources and Studies. Our Clinical Studies Transparency Officer also enters the relevant information in ClinicalTrials.gov. Accountability for the PASS process lies with the Head of the Global Patient Safety unit.

Up-to-date labeling and product information

Product information documents – such as package inserts, summaries of product characteristics, U.S. prescribing information, instructions for use, and illustrations – provide consumers, end-users, and healthcare professionals with information and labeling about the medicinal products we market. Employees involved in product information and labeling receive role-specific training. Our procedures for medicinal product information are designed to ensure that we update safety information in public portals, on package inserts and in illustrations for all the medicinal products we market. They also aim to ensure that safety information about known product characteristics, indications, ingredients, dosage, storage, warnings, and precautions as well as potential side effects is available to healthcare professionals, consumers and end-users. Package leaflets may include instructions for disposing environmentally harmful ingredients. We regularly review and update our information documents to ensure they reflect the latest safety, efficacy and formulation information. Actual and potential impacts on consumers and end-users of our medicinal products contribute to our product information documents. The Head of the Global Labeling unit is responsible for drug information and labeling.

Safety communications

If our ongoing safety monitoring activities of our medicinal products identify important new safety findings with a potential impact on the benefit-risk profile, we organize the respective safety communication after obtaining the necessary approvals from the relevant regulatory authorities. The safety communication message is delivered to the target group (such as our business partners, healthcare professionals and consumers and end-users) in the appropriate format. Depending on the life cycle of the medicinal product in question and applicable requirements, communication takes the form of a letter, an e-mail, a video, a written statement on a website, or via other internet-based channels such as social media. Safety communication messages disseminated to healthcare professionals are tracked. Employee training for the safety communication processes is covered by role-specific training. The responsibility for such processes lies with the Global Patient Safety unit.

In 2025, we had 3 drug product recalls affecting 446,689 units in total (2024: 5 recalls; 46,465 units).

Our complaint-handling mechanisms

Whistleblowing and complaints system

We have set up a Group-wide complaints system that can be used to report actual and potential violations. A central component of this is our free and anonymous Compliance Hotline. Complaints received via our Compliance Hotline are received by a central and independent team within Group Compliance. This team evaluates the reports and either initiates an investigation directly or, depending on the type, content and nature of the report, may forward the report to the responsible function. If the complaint involves concerns from consumers and end-users regarding medicinal products, the report is forwarded to the appropriate function (for example, the Global Patient Safety unit in case of adverse events) for further follow-up and for initiating appropriate measures. The end-to-end investigation process and remedial action lies within the responsibility of the respective function. Generally, if communication with the reporting person is possible, we would confirm receipt of the report within seven days and aim to provide information on the status of reported concerns within three months after the confirmation of receipt. We do not assess whether consumers and end-users are aware of and trust our Compliance Hotline as a way to raise concern. More information on the Compliance Hotline can be found under corporate culture (G1).

Information and complaint channel

Our general call center 720 serves all customer groups, including healthcare professionals, patients and carers. Contact information, such as phone numbers and e-mail addresses, is provided in the package leaflets or the summaries of product characteristics of medicinal products as well as on the websites of the therapeutic areas. We are legally obligated to be available for reporting adverse events and product complaints, and reconciliation processes are in place for such requests to ensure that all cases are processed appropriately. Our call center services, which may be outsourced, are closely monitored for quality and efficiency and supported by service level agreements with the aim of ensuring high standards. Agents in the call center are subject to knowledge verification and regular training. We regularly review reports and analyses to maintain the availability and functionality of our communication channels. Documenting and tracking adverse event and product complaint reports are integral to our quality management system. We also record and analyze medical information requests to gain insights and assess the recognition and trustworthiness of our call center 720. We do not assess whether consumers and end-users are aware of and trust our call center 720 as a way to raise concerns.

With a centralized follow-up of corrective and preventive actions (CAPA), we help to verify the effectiveness of procedures in connection with complaints. To this end, we carry out regular trend analyses of complaints and their causes in order to identify areas that require improvement. All complaints received are anonymized. Digital systems are used to track complaints, while regular meetings with service providers in accordance with the service level agreements are intended to ensure effectiveness.

Combating product crime

We are committed to combating the illegal counterfeiting of our products. Our Group standard, Illicit Trade & Product Crime Prevention, sets out binding procedures for preventing, identifying and responding to pharmaceutical crime. Implementation is driven by a multidisciplinary team including security personnel and specialists from our Legal, Trademark, Procurement, Patient Safety, Regulatory Affairs, and Quality Assurance functions. This collaborative approach ensures comprehensive coverage and rapid response capabilities across all our operations.

We monitor online pharmacies, e-commerce platforms and social media to detect and remove illicit online listings of our medicinal products. Our investigations – both online and offline – aim to identify and disrupt the availability of illicit products in both legitimate and illegitimate channels. In close cooperation with law enforcement authorities, we support the prosecution of offenders. Our Compliance Hotline, 720 call center and patient safety and product complaint systems are among the channels stakeholders can use to report suspected illegitimate products. We have established processes to ensure rapid and reliable authentication of suspected counterfeit medicinal products. All reports of suspected product-related crime are documented in our central, Group-wide reporting system, enabling us to compile comprehensive intelligence, link incidents and respond more effectively.

We also strive to fulfill regulatory requirements on product serialization and track-and-trace technologies across multiple countries and regions, including clear barcoding of individually and multiple packaged products. This enables supply chain traceability and increases the likelihood that counterfeit products are detected before they reach patients. Our risk-based approach involves adding extra security features to certain products to make them easier to verify as genuine, thereby promoting consumer and end-user safety.

More broadly, we support global initiatives to protect patients, such as the Global Pharma Health Fund (GPHF), a non-profit organization that supplies the GPHF-Minilab^®. This mobile compact laboratory enables users to quickly and effectively test the presence and quantity of 113 different active ingredients, particularly in regions with limited access to healthcare solutions.

Our actions related to consumers and end-users (S4-4)

Our actions in relation to consumers and end-users follow our policies and aim to improve the protection and advance the healthcare of consumers and end-users. Through the following actions, we aim to make progress toward the targets we have set ourselves, which are detailed under S4-5. This primarily affects consumers and end-users, R&D functions and our Healthcare business sector as well as external service providers. Unless otherwise stated, all actions mentioned are to be regarded as ongoing and have no fixed completion date.

Inspections and audits to ensure patient safety

We conduct global internal audits to ensure compliance with legal and further requirements such as Good Clinical or Pharmacovigilance Practices as well as our internal standards, and to verify the effectiveness of protection measures for consumers and end-users. These audits affect our R&D function as well as further Healthcare units and external service providers. We carried out 109 audits in 2025 (2024: 113). Regular quality management reviews with Senior Management involve sharing identified trends and risks from audits and inspections. Internal audits that detect relevant observations trigger a root cause analysis and the definition of corrective and preventive actions, which are checked and approved by the R&D Quality Assurance department. In addition, regulatory authorities check whether we are complying with legal requirements and our internal standards. In 2025, 13 health authority inspections took place (2024: 17). We follow up on the findings of these inspections and take necessary actions to ensure the ongoing compliance of our pharmacovigilance system. All audits were completed without significant safety risks to subjects or impact on subject rights or data integrity that could lead to legal action. In addition, all inspections were completed without legal action by an authority. By conducting audits according to pre-defined audit plans, we ensure that our processes are appropriate and that the safety and rights of our consumers and end-users are at no time at risk. Audits and inspections accordingly also constitute a means to allow us to compliantly develop drugs, mitigating the risks for the company arising from dependencies on our consumers and end-users including liability claims.

Patient Safety Day

The aim of our Patient Safety Day is to raise employees’ awareness of patient safety and the importance of pharmacovigilance in the local subsidiaries. This annual event is held in accordance with the WHO celebration event schedule. The global awareness campaign took place in September 2025, focusing in particular on ensuring safe care for every newborn and every child. We currently have no specific effectiveness tracking in place. Raising awareness of pharmacovigilance helps to protect patient safety, thus reducing the risk of our company being exposed to liability claims regarding pharmaceutical products.

Roles and responsibilities

Our Global Development unit is responsible for clinical development, including clinical studies and the associated management processes (connected to IROs S4-PI-01; S4-PI-02; S4-PI-03, S4-PI-05; S4-R-01; S4-R-02; S4-O-01). The Head of Global Research and Development reports to the CEO of the Healthcare business sector, who is also a Member of the Executive Board. We review the progress of the development of new products based on predefined milestones. Depending on the results of the clinical studies, we decide whether to continue, change or discontinue development. The Human Exposure Group, led by our Chief Medical Officer, carefully evaluates whether it is safe to expose humans to a new investigational drug in a first-in-human study.

For our medications that are endorsed to undergo active clinical development, two internal boards govern the clinical study protocols and operational plans of our clinical studies. The Integrated Protocol Review Committee is responsible for the studies we conduct with products that are in clinical development. The integrated Medical Study Governance Board is responsible for our own studies on products that have already been approved as well as for all studies conducted by independent investigators that are supported by our company (so-called investigator-sponsored studies). Both boards consist of medical and scientific experts as well as managers with many years of experience in clinical research.

We continuously analyze the potential risks for the participants in clinical studies and for the consumers and end-users of our medicinal products after commercial availability. Our Medical Safety and Ethics Board constitutes the most senior decision-making body for ensuring that the usage of our medicinal products across their life cycle is safe and that they exhibit a positive benefit-risk ratio. It also convenes as required to resolve any emerging questions related to patient safety and the benefit-risk profile of our medicinal products and to discuss particular actual or potential negative safety events. Depending on the type of issue, the board might mandate the termination of a trial, the adaptation of a clinical trial protocol, or a product batch recall, among other actions, to ensure the safety of our patients.

Our Global Patient Safety unit is responsible for managing patient safety (connected to IROs S4-PI-01; S4-PI-02; S4-PI-03; S4-R-01; S4-R-02; S4-O-01). The unit analyzes all safety data and assesses the risk profile on this basis, if necessary. If applicable, we inform regulatory authorities, healthcare professionals and patients about new risks, additional risk mitigation measures and potential changes to the benefit-risk profile. Our Healthcare Quality unit handles quality complaints in connection with our medicinal products.

Our Corporate Security team manages all security risks across our organization, including our strategies and initiatives against product-related crime (connected to IRO S4-PI-04). Supported by experts from Legal, Export Control, Supply Chain, Patient Safety, Regulatory Affairs, and Quality Assurance at both global and local levels, they work collaboratively to safeguard our products and patients.

Our targets related to consumers and end-users (S4-5)

Specific information about our target-setting process in relation to the stated target cannot be disclosed. Furthermore, we lack systematic mechanisms to compare our performance with consumer expectations and experiences, and we have not implemented structured processes for collaborative learning and improvement with consumers. For both audits and inspections, we conduct internal learning sessions. Our current approach does not involve direct engagement with consumers and end-users at this stage. In addition, we are looking for ways to improve our understanding of the expectations and experiences of consumers and end-users. We recognize the importance of learning from our achievements and working with consumers and end-users to identify areas for improvement. Our ambition is to systematically identify, manage and report risks associated with consumers and end-users. More information on our actions can be found under S4-4.

Access to our products and services and access to (quality) information

Our strategy to improve health equity

Our company is committed to promoting health equity, a strategic priority aligned with our sustainability strategy. At least half of the world’s population lacks access to essential health services, and approximately 344 million people live in poverty due to health-related expenses. Achieving health equity involves ensuring communities have access to quality care and addressing inequities in health and living conditions. Overcoming this multifaceted challenge requires collaboration among all health stakeholders. Every community deserves a fair chance at achieving optimal health. We help by working to lower systemic barriers and by creating sustainable, long-term solutions and partnerships to improve health outcomes. We integrate a people-centered approach.

Our efforts to promote health equity are guided by our principles: First, we start with people. We continually strive to respond to the needs of patients, carers and communities and always treat them as active participants in, and beneficiaries of, their care solutions. Second, we build through systems. This reflects our understanding of the importance of aligning our actions with global and local health priorities and forging partnerships that foster the integration of health systems over the long term. Third, we sustain through shared value. Promoting health equity is beneficial for our business too. Consequently, we continually look for new ways to embed health equity into our commercial strategy as a growth driver and then to design sustainable and scalable business models to promote it.

A key component of our health equity strategy is enabling access to our medicines in low- and middle-income countries. We adopt a holistic approach in addressing the availability, accessibility, and affordability challenges to access these markets:

• Availability: We drive needs-based research and development, broaden and accelerate registration and responsibly manage intellectual property to accelerate the fastest and broadest access to innovation.

• Accessibility: We support countries in strengthening health infrastructure and services to improve patient access to the best possible care. In addition, we design and execute local advocacy initiatives to improve our products’ accessibility.

• Affordability: We implement innovative mechanisms to ensure equitable and sustainable access to our innovations and established products.

Our medicines’ availability and accessibility depend on a multi-stage process. Our efforts have always been directed toward ensuring that our medicines are readily available and that sustainable financing mechanisms are in place to meet patient needs. One way we ensure affordable access to our healthcare portfolio is by conducting annual price analyses. The purpose is to validate price thresholds and to provide our subsidiaries with guidance on local pricing for the following year. This consistent, data-driven approach combined with equitable pricing initiatives helps our subsidiaries meet their patients’ access needs.

We run programs designed to lower barriers to health equity such as our Systematic Health Access and Patient Enablement (SHAPE) program. Our equitable pricing initiatives aim not only to improve access for underserved populations in low- and middle-income countries (LMICs), but also for patients with affordability challenges in high-income countries. More information on our actions can be found under S4-4.

Besides enabling access to our healthcare portfolio, our global health engagement also encompasses combatting diseases that disproportionally impact populations in LMICs. These include schistosomiasis, a neglected tropical disease (NTD), and malaria. Moreover, we strengthen healthcare systems in LMICs by investing in local R&D, manufacturing, education, and infrastructure.

Our overall efforts focus on reaching underserved populations in LMICs, where we aim to reach over 170 million patients annually by 2030. This includes more than 80 million through our healthcare portfolio and over 90 million through our global health initiatives. S4-5 provides more information on our targets.

Our policies related to consumers and end-users (S4-1)

Our human rights commitment

As stated in our Human Rights Charter, we respect the right to health and are committed to providing high-quality, safe health solutions for all. Our philosophy follows the guidance from the World Health Organization (WHO), which demands “the right to the highest attainable standard of physical and mental health”. We apply the concept of implementing this especially for populations in LMICs as well as for populations with access challenges in high-income countries.

Regarding complaint-handling mechanisms and further details on how we comply with laws and regulations but also international guidelines and principles concerning our products as well as how we report human rights incidents, the same apply as for the health and safety of our patients. More information can be found under health and safety.

Our processes for engaging with consumers and end-users (S4-2)

When planning our activities regarding access to products and services, as well as access to (quality) information, we do not have specific processes in place for involving consumers and end-users. Further information on our processes for engaging with consumers and end-users can also be found under health and safety. We conduct regular stakeholder dialogues with relevant groups, such as payers, payer advisors, patient representatives, and healthcare professionals, to understand the care landscape and the needs of patients and healthcare systems. Our exchange also extends to international organizations, non-governmental organizations, local institutions, and universities. When it comes to addressing global health challenges, we focus particularly on LMICs. Stakeholder dialogue takes place in all phases of the life cycle of our products – from research and development to market launch and post-launch. Engagement takes place through various platforms and in the form of market research projects, roundtables, discussions with stakeholders, education and awareness programs, public consultations, and the involvement of payers. The Member of the Executive Board and CEO of Healthcare is the most senior role responsible for ensuring the engagement.

Our actions related to consumers and end-users (S4-4)

Our actions related to consumers and end-users follow our strategy and aim to improve access to our products and services as well as to (quality) information. In 2025, we served around 108 million patients (2024: 103 million) with our healthcare portfolio, thereof around 70 million patients in LMICs (2024: 65 million). Furthermore, we enabled the treatment of around 75 million people with praziquantel against schistosomiasis (2024: 81 million). The total number of people reached in 2025 amounted to 182 million (2024: 184 million), which we show as a strategic sustainability key indicator (number of people treated with our Healthcare products) under ESRS 2 (SBM-1). Through the following actions, we aim to make progress toward the targets we have set ourselves. Unless otherwise stated, all actions mentioned are to be regarded as ongoing and have no fixed completion date.

In 2025, we allocated € 48 million of operating expenditures (OpEx) to all our actions described in this report related to consumers and end-users to improve access to our products and services as well as to (quality) information. These OpEx are included in the respective lines of the Consolidated Income Statement. For fiscal 2026, we intend to allocate € 31 million of OpEx.

Access to health in low- and middle-income countries

As part of the implementation of our health equity ambition, SHAPE is our long-term, systematic flagship program for improving the availability, accessibility and affordability of our Healthcare medicinal products for underserved patient populations in LMICs. The program includes both existing and upcoming products in our healthcare portfolio. Specifically, we pursue a three-pronged approach that goes deeper, wider and faster. We are going deeper in our collaborative efforts to remove barriers to access in individual countries, including launching equitable pricing strategies and health system strengthening initiatives. We are going wider by making our medicines available in more countries, focusing on those with significant prevalence. And lastly, we are going faster when introducing new products to LMICs, reducing the time between the first global launch and regulatory filings in those countries supported by a streamlined LMIC launch planning process, governance and framework. We anticipate that the implementation and expansion of SHAPE will continue to positively impact our consumers and end-users, leading to more equitable access and further initiatives to strengthen the healthcare system in LMICs.

As of 2025, 15 pilot projects are currently operational in countries such as Argentina, Brazil, Egypt, Indonesia, Mexico, and Peru as well as several other countries in Central America and Africa. In Egypt, for example, we have implemented a SHAPE project for Erbitux^®. The program aims to reduce the prevalence and mortality rates of colorectal cancers by increasing public awareness, providing continuous medical education for healthcare practitioners and supporting diagnosis and treatment. We also collaborate with the Cancer Early Detection Presidential initiative by providing education programs for healthcare professionals.

We continue to drive forward activities in and for LMICs through our health equity and accessibility initiatives that help strengthen local healthcare systems. In this way, we prepare and promote access to our innovations and products for high-burden, non-communicable diseases such as various cancer indications. We adopt a partnership approach to maximize our impact in this complex and challenging environment. This includes the shared value program, which supports our teams in LMICs in implementing initiatives that address health system barriers to patient access through capacity building and training for healthcare professionals. Our stakeholders are patients, health authorities, payers and healthcare providers.

The implementation of our aforementioned initiatives is supplemented by monitoring and evaluation processes. In our SHAPE program, the number of patients is the most important key indicator. This is tracked and evaluated on a quarterly basis. In addition, we continuously monitor the progress of the projects regarding important milestones. At the end of the year, we set and validate annual targets for patient numbers and investment needs to ensure the effective implementation of approved projects.

Eliminating schistosomiasis as a public health problem

We aim to eliminate schistosomiasis as a public health problem by 2030, in accordance with the Neglected Tropical Diseases (NTD) Roadmap 2021 – 2030 of the World Health Organization (WHO). We are committed to the targets of the Kigali Declaration on NTDs, according to which participating companies, governments and private organizations pledge to contain and ultimately eliminate the 21 NTDs, including schistosomiasis. Schistosomiasis, also known as bilharzia, is caused by parasitic worms and affects over 250 million people worldwide, mainly in sub-Saharan Africa. To fight this disease, we have adopted an integrated strategy, which we are implementing in close collaboration with multiple partners worldwide. Our approach is based on four pillars:

• Treatments: As part of our partnership with WHO, we donate up to 250 million praziquantel tablets every year for the treatment of schistosomiasis in countries where the disease is endemic. In 2025, we provided 187 million tablets (2024: 203 million). Based on the treatment guidance of WHO, we estimate that this number of tablets enabled the treatment of around 75 million people (2024: 81 million). Nearly 50 years after its development, praziquantel remains the standard of care for the effective treatment of schistosomiasis around the world. Our target is to reach over 90 million people per year by 2030. As part of the Pediatric Praziquantel Consortium, supported by external funds from Global Health Innovative Technology Fund and the European and Developing Countries Clinical Trials Partnership, we developed arpraziquantel, a new treatment for children aged three months to six years. After the European Medicines Agency issued a positive scientific opinion, in 2024 the WHO included arpraziquantel in its List of Prequalified Medicinal Products. Arpraziquantel dispersible tablets became available in the first African country, Uganda, at the end of 2024; the first preschool-aged children received the medicine in March 2025 under the Consortium’s ADOPT program. This program, which is being conducted in Côte d’Ivoire, Kenya and Uganda, aims to identify routine practices for expanding the new medicine’s use in countries where schistosomiasis is endemic. Arpraziquantel was officially included into the WHO Essential Medicines List in September 2025. We applied for marketing authorizations in five countries in 2025: Côte d’Ivoire, Kenya, Senegal, and Uganda as well as Tanzania, where the authorization was already granted. We also continued our work to ensure large-scale local production and sustainable access to the medication.

• Research and development (R&D): We are advancing R&D for a next generation of drugs and have a promising candidate in the preclinical phase. In addition, our participation in a collaborative effort promotes the development of new and more sensitive diagnostics, which will help enable the transition from mass drug administration programs to target treatments.

• Health education for behavioral change: Health education is a crucial component in behavioral change strategies to control and eliminate schistosomiasis. It aims to modify risky behaviors related to water contact and sanitation practices. This will ultimately reduce disease transmission and improve treatment-seeking behavior. Effective health education for schistosomiasis focuses on increasing knowledge, fostering positive attitudes and promoting the adoption of healthy habits. We implement three collaborative initiatives involving local African institutions to raise disease awareness for prevention as well as to influence national policies.

• Advocacy and partnerships: We intend to make even faster progress in the fight against schistosomiasis. That is why we collaborate with a variety of stakeholders – such as academic institutions, research centers, international organizations, governments, and the private sector – and maintain an ongoing dialogue with the wider stakeholder community, for example through the Global Schistosomiasis Alliance (GSA). In October 2025, we signed a new Memorandum of Understanding (MOU) with the END Fund to strengthen our collaborative efforts to eliminate schistosomiasis. The MOU builds on more than a decade of partnership, to establish a strategic framework for joint initiatives to drive innovation and expand equitable and sustainable access to treatments.

Further information on our targets can be found under S4-5.

We collect various parameters: the demand for praziquantel tablets through WHO, the production and supply of tablets, the number of people reached (school-aged children and adults), and the countries in which they are used are tracked. We continuously monitor the program and outcomes. Final figures are consolidated and assessed on an annual basis. We expect to continue positively impacting our consumers and end-users through the availability of our products via new, diversified mechanisms for sustainable access, to reach people of all ages who are in need. In the light of the significant effects of recent donor funding cuts, such as those from United States Agency for International Development (USAID), we are exploring new strategies and interventions to reduce the prevalence of schistosomiasis infections.

Preventing and controlling malaria to support elimination

According to WHO estimates, almost half of the world’s population is at risk of contracting malaria. The latest annual figures report over 260 million cases of malaria and close to 600,000 related deaths, with around 75% occurring in children under the age of five. Currently, 95% of cases and deaths occur in Africa.

Increasing drug resistance and the need for additional preventive measures render innovations necessary. We have invested in the development of a new medicine to cure and prevent the disease. This medicine has successfully completed Phase IIa clinical trials; the next phase of development is under preparation. The investment in this new health solution aims to create a significantly positive impact from health and socio-economical perspectives in the countries where malaria is endemic. The evaluation of the impact is currently in progress using an integrated model collaboratively developed. We monitor the progress of our activities on an ongoing basis. Reports to governance bodies are submitted upon reaching key milestones, which are used as a basis for making decisions. The development of innovations is complemented by the evaluation of mechanisms that will ensure sustainable and more equitable access to products, once available.

Health education and capacity building

The private sector is a crucial partner in responding to global health threats. We help to ensure that healthcare systems are prepared to address emergencies effectively and to sustainably deliver care to patients in need. In the area of global health, we have established a portfolio of collaborative projects that build up capacity and strengthen healthcare systems in LMICs by investing in four key areas: local research and development, production and supply chains, education and awareness, as well as health infrastructure and training.

We contribute to health equity by building scientific capacity and competencies through our R&D programs with a primary focus on schistosomiasis and malaria. Through technology transfers, we support local production to help countries to become self-sufficient and serve local in-need populations. We build sustainable supply chains of local distributors in Africa through partnership. We also invest in education and behavioral change initiatives to raise awareness on schistosomiasis, through our collaboration with the NALA Foundation in Ethiopia as well as our storytelling approach in Ethiopia, Kenya and Rwanda as examples. We collaboratively develop and implement new approaches and initiatives to strengthen healthcare systems and improve access to, for example, thyroid care in Indonesia, Peru, the Philippines, and in African countries, starting with Kenya.

Equitable pricing approaches

The prices of our products should not be a barrier to accessing treatment. We strive to ensure affordable access to our healthcare portfolio by monitoring the dynamic healthcare environment and markets, pricing and reimbursement systems as well as legal and regulatory guidelines and adjusting our prices where necessary. We have therefore implemented a multitude of equitable approaches including value-based contracting, Patient Access Programs (PAP) and second brands.

We are committed to advancing value-based healthcare through pricing and contracting mechanisms that comply with applicable local laws and regulations. In collaboration with payers, such as health insurance companies, we have developed various product- and market-specific reimbursement and contracting models. These help to provide patients with prompt access to our innovations. In 2025, we continued to implement and maintain innovative risk-sharing agreements, which give patients with multiple sclerosis direct access to Mavenclad^® with agreements in Europe, Latin America as well as the Middle East and Africa. We also implemented an adherence-based agreement for Saizen^® in Spain and value-based contracting for multiple products in Korea.

Our PAPs are self-sustaining commercial programs through which we provide approved medicines to underserved populations in LMICs as well as patients with affordability challenges in high-income countries. In 2025, we operated PAPs for nine of our innovative products in over 20 global markets. In India, for example, we offer a PAP for our oncology drug Erbitux^® through which financial assistance to eligible underprivileged patients in line with local laws and regulations is provided. Since we initiated the program in 2013, it has been made available to approximately over 10,000 patients nationally. In 2025, around 1,500 patients benefited from the program (2024: around 1,500). In the Kuwait and United Arab Emirates, we introduced a patient affordability initiative to provide access to our oncology and multiple sclerosis treatments to patients who cannot afford the cost. This program is carried out in collaboration with third-party providers and charitable organizations. In 2025, 54 patients benefited from this program (2024: 62).

For some of our existing high-quality products, we offer second brands at affordable prices, especially in countries where many patients live on low incomes. Second brands of the beta-blocker bisoprolol (Concor^®) are available at affordable prices in Botswana, Brazil, Chile, Greece, Peru, Poland, Slovakia, and South Africa. Similarly, second brands of levothyroxine (Euthyrox^®) are available in Brazil, Mexico and Peru, and second brands of extended-release metformin (Glucophage^® and Glucophage XR^®) are available in Chile, India, Mexico, Peru, and South Korea.

We expect that the introduction and expansion of our equitable pricing initiatives will continue to have a positive impact on our consumers and end-users over the next 3-5 years and beyond. We monitor the effectiveness of our equitable pricing initiatives on an ongoing basis; mechanisms used to assess the effectiveness vary. For example, the effectiveness of our value-based contracting programs is assessed against pre-set outcomes in the contract, such as financial indicators, performance, and patient adherence-based outcomes. We monitor the outcome of our Patient Access Programs (PAPs) based on patient numbers reached in the respective target populations.

Roles and responsibilities

The member of the Executive Board and CEO of Healthcare has the overarching responsibility for the initiatives related to access to our products and access to (quality) information.

Our Global Health & Health Equity organization is responsible for Group-wide initiatives and programs aimed at developing and providing access to health solutions and driving health equity by creating equitable and sustainable access mechanisms for patients and communities (connected to IROs S4-PI-05; S4-PI-06). Our team works closely with the various sectors to leverage our collective strengths and expertise internally as well as with a large number of international and local partners. Beyond enabling extended access to our healthcare portfolio by leveraging strategic approaches and shared value initiatives, we also focus on diseases that disproportionally impact populations in LMICs by prioritizing efforts for disease control toward the elimination of schistosomiasis as a public health problem, and catalyzing innovations for malaria.

Our Global Value Demonstration, Market Access & Pricing (GVAP) unit sets the prices for the market launch in coordination with the respective franchises and is responsible for the cross-functional global SHAPE program (connected to IROs S4-PI-05; S4-PI-06). It reports directly to a member of our Healthcare Executive Committee. In addition, the GVAP unit systematically evaluates our medicine portfolios and implements equitable access initiatives. Our local subsidiaries are responsible for price management and adapt prices to changing local conditions. This is done in accordance with our pricing governance and the defined price approval process.

Our targets related to consumers and end-users (S4-5)

The measurement of metrics related to consumers and end-users has not been separately validated by an external body.