Sartorius Stedim Biotech

Sartorius Stedim Biotech S.A. is administered by a Board of Directors of eight members, three of whom are independent and one of whom represents employees. Directors are appointed for three-year terms and, except for the employee representative, are elected individually by shareholders at Ordinary General Meetings. The composition reflects controlling shareholder Sartorius AG's aim of a long-lasting balance between shareholder representatives, independent, executive and employee directors. The CEO is the only executive member (14.3% executive, 85.7% non-executive). Women make up 42.9% of the Board (three members) and independent directors 42%, both ratios excluding the employee representative per French rules. The Audit Committee monitors sustainability-related impacts, risks and opportunities and makes recommendations to the Board. At Sartorius Group level, a Corporate Sustainability department under the Group CEO identifies, manages and reports on these matters. The Board defines sustainability strategy and monitors progress; the Audit Committee oversees sustainability reporting. Corporate Sustainability reported to the Committee and Board in Q2, Q3 and Q4 on CSRD and supply chain due diligence. Specific IRO management controls were still being defined and not implemented in the reporting year. The Board self-assesses that it has the necessary skills and expertise. (p.86-87)

In the reporting year, the Board of Directors and the Audit Committee were involved by the Corporate Sustainability department on an ad hoc basis in the planning and execution of the ESRS double materiality assessment and were informed of its results. This included a description of the impacts, risks and opportunities identified as material under SBM-3, together with a presentation of the current management approach regarding policies, actions, metrics and targets, including an assessment of their effectiveness. Any areas of potential and possible measures for the further development of policies, actions, metrics and targets were presented for decision. The implications for corporate strategy and operational planning were also discussed and recorded in the results. In addition, the Board of Directors and the Audit Committee were involved in the planning and execution of the risk analysis performed under the Supply Chain Due Diligence Regulation and informed about its results and the effectiveness of the corresponding risk management system. (p.87)

The remuneration policy for the CEO includes fixed, short-term variable (STI) and long-term variable (LTI) components and meets the French Commercial Code and AFEP-MEDEF Code recommendations. The system is set by the Board on the recommendation of the Remuneration and Nomination Committee. The Employee Net Promoter Score (ENPS) is anchored in the STI with a one-year assessment basis, accounting for 10% of total STI as a cash payment. The ENPS target is an annual score of 35 points, calculated from two employee surveys; target achievement is 100% at the target value, with a minimum of 70% and a cap of 120%, and a linear payout between these. The LTI includes a cash component with a four-year assessment period tied to reducing the CO2eq emission intensity of parent company Sartorius AG, targeting an average annual reduction of 10%. This accounts for 50% of total LTI, with minimum target achievement of 50% (below which payout is zero) and a cap of 120%. The first tranche started January 1, 2022 and will first pay out in 2026 for the 2022 to 2025 period. Non-executive directors had no sustainability-related remuneration components. (p.87-88)

Sartorius Stedim Biotech treats the exercise of due diligence on sustainability matters as a business conduct task. A table maps the core elements of due diligence to the relevant paragraphs of the Sustainability Statement. Embedding due diligence in governance, strategy and business model is covered under ESRS 2 GOV-2, GOV-3 and SBM-3. Engaging with affected stakeholders across all key steps is covered under ESRS 2 GOV-2, SBM-2 and IRO-1, plus the E1, E2, E5, S1 and S2 MDR-P disclosures. Identifying and assessing adverse impacts is covered under ESRS 2 IRO-1 and SBM-3. Taking action to address adverse impacts is covered under the E1, E2, E5, S1 and S2 MDR-A disclosures. Tracking effectiveness and communicating is covered under the corresponding MDR-M and MDR-T disclosures for E1, E2, E5, S1 and S2. (p.88-89)

In the reporting year, the sustainability reporting process consisted of several individual data processes, each organized by data process owners at Group level. The Corporate Sustainability department is responsible for the overall process, its coordination and control, based on the Sustainability Statement Reporting Manual and the principles and standards defined in it, including accounting policies and material internal controls. Internal controls were prioritized on a risk-oriented basis. The most important reporting risks include incorrect or incomplete data delivery. To mitigate these risks, the company has implemented process-specific controls, in particular the four-eye control principle and plausibility checks such as completeness checks and deviation analyses. Implementation of internal controls at all process levels is continuously promoted. Reporting to the Board of Directors and Audit Committee will take place once the corresponding internal control system for sustainability reporting has been established, which will be the next step. (p.89-90)

The company offers a broad portfolio of Bioprocess Solutions, covering filtration, fluid management, fermentation and purification, focused on the production processes of the biopharmaceutical industry. It has a global reach with manufacturing, R&D and sales entities in Europe, North America and Asia, and no bans on major products in specific markets. Its value chain comprises upstream purchased goods and services, its own operations, and the downstream chain of products and services sold. Upstream, it works with roughly 12,000 direct suppliers plus indirect suppliers, mostly smaller companies, with some products such as bioreactors made through contract manufacturing. Own operations include R&D, Corporate Sourcing, Production and Marketing & Sales, with production sites in EMEA, APAC and Americas and sales subsidiaries and agencies in more than 110 countries. Sales are mostly direct, with major accounts handled by a global key account team, plus laboratory retailers and online. Downstream customers are biopharmaceutical corporates and scientific institutions, none exceeding 5% of sales volume, on a business-to-business basis. On sustainability, the company has begun conducting Lifecycle Assessments and Product Carbon Footprints for first products, contributes to Sartorius AG's group climate strategy, and aims to optimize consumables and instruments for resource use and recycling. (p.90-91)

Sartorius Stedim Biotech systematically factors stakeholder requirements and feedback into its strategy process and maintains continuous dialogue with its most important stakeholder groups: customers, business partners and suppliers together with workers along the value chain, and investors. With customers, sustainability matters such as decarbonization, climate neutrality and other standards are discussed through individual dialogues and industry association work (for example BioPhorum, NIMBL, PSCI). The own workforce is engaged on an ongoing basis through works councils, board-level representation, and twice-yearly pulse check surveys whose insights drive improvements via HR and managers. Investors are engaged as part of regular capital market communication, including ESG conferences and calls. Suppliers, business partners and value chain workers are engaged through training, structured queries, risk-based audits, surveys and anonymous whistleblower systems, aiming to align conditions with the Sartorius Code of Conduct for Business Partners. Functions such as Investor Relations, Sales, HR, Compliance and Corporate Sourcing maintain continuous dialogue, with topics bundled by Corporate Sustainability and reported to the Board. Dialogue in the reporting year deepened understanding of climate change mitigation, recycled or renewable materials, renewable energies and PFAS, which were integrated into the double materiality assessment and informed strategic priorities. (p.91-92)

The double materiality assessment identified 22 material impacts and three material risks across the value chain, with no material opportunities in the reporting year, and no material differences between company units or regions. On climate change, actual negative impacts arise across the value chain from energy use in suppliers' production, own operations and product use; no material climate-related physical or transition risks were found, so no separate climate resilience analysis was carried out for fiscal 2024. On pollution, actual and potential negative impacts and financial risks relate to substances of concern and substances of very high concern, including PFAS, with regulatory non-compliance risks. On circular economy, mostly single-use products drive negative impacts in resource inflows, waste and resource outflows. For own workforce, positive impacts on working conditions and equal treatment coexist with potential negative impacts on health and safety and on violence and harassment. For value chain workers, potential negative impacts on working conditions and equal treatment among upstream suppliers were identified, with no positive impacts and no material risks. On business conduct, corporate culture has a positive impact on employee satisfaction alongside a financial risk if the culture becomes unattractive. No measurable financial effects of risks are yet reported; the Board judged the business model and strategy sufficiently resilient qualitatively. This is the first reporting period. (p.92-98)

The process to identify, assess and prioritize material impacts, risks and opportunities was carried out in the reporting year by Corporate Sustainability with Finance & Controlling, based on ESRS and its implementation guidelines, drawing on the company's risk management methods, internal expert knowledge and stakeholder views, on a gross basis. Step 1 identified relevant topics using ESRS, the Taxonomy Regulation and GRI plus stakeholder dialogues, with stakeholders split into users of sustainability statements and affected stakeholders; external experts were not consulted at this stage. Step 2 assessed IROs qualitatively on a one to four scale: actual and potential impacts by magnitude, scope and irreversibility (plus likelihood for potential impacts, except human rights impacts), and risks by severity scaled with likelihood. Assessment was decentralized by departments per unit, then consolidated at Group level. Step 3 applied materiality thresholds. Step 4 validated results through cross-checks, with the Board confirming material IROs. The report also gives topic-specific IRO-1 disclosures for climate (E1, including physical and transition risk analysis under specified scenarios, finding no material climate risks), pollution (E2, guided by REACH), resource use (E5), business conduct (G1), and water and biodiversity (E3/E4, finding no material impacts, risks or opportunities). Results are integrated with Corporate Risk Management. (p.98-105)

An index table summarizes the ESRS disclosure requirements contained in the Sustainability Statement, with page numbers and paragraph references. Reportable disclosures were determined using EFRAG's implementation guide (Data Point List). The company did not identify any immaterial data points and therefore does not make use of the principle of materiality of information. In this first reporting year it concentrated on mandatory disclosures but voluntarily included several social disclosures subject to a one-year transitional period: S1-7, S1-8, S1-11, S1-12, S1-13, S1-14 and S1-15. The index covers general information (BP-1, BP-2, GOV-1 to GOV-5, SBM-1 to SBM-3, IRO-1, IRO-2); environmental information including climate change (E1-1 to E1-9), pollution (E2-1 to E2-6), water and marine resources, biodiversity and ecosystems, and resource use and circular economy (E5-1 to E5-6); social information for own workforce (S1-1 to S1-17) and workers in the value chain (S2-1 to S2-5); and governance information on corporate culture (G1-1), along with the related MDR-P, MDR-A, MDR-T and MDR-M disclosures. (p.106-110)

Sartorius Stedim Biotech states that as early as 2021 it identified important decarbonization levers for reducing greenhouse gas (GHG) emissions on the basis of a GHG emissions screening and initiated actions to reduce them. An ESRS-compliant transition plan for climate change mitigation based on this work will be developed in fiscal 2025. The company does not present a completed transition plan for the reporting year. (Sustainability Statement, page 125)

The company reports that it contributes to the group-wide climate strategy of its parent Sartorius AG to continuously reduce the Group's absolute GHG emissions. The Corporate Sustainability department is responsible for coordinating climate change mitigation. Sartorius Stedim Biotech has not yet developed a comprehensive policy covering general management principles, guidelines and specific responsibilities, explaining that the initial focus was on initiating specific mitigation measures and that prioritization was required due to resource constraints. It is working with internal and external experts to define a formal policy whose main contents will include reducing GHG emissions and increasing energy efficiency through various levers. An important basis for the policy is adapting the database that enables management of measures. The company aims to complete and publish the policy in fiscal 2025. (Sustainability Statement, page 125)

Sartorius Stedim Biotech reports having already undertaken many actions to reduce GHG emissions toward its company-wide climate targets, continued in the reporting year. Examples by lever: energy and infrastructure (gradually converting supply contracts to renewable electricity and installing solar panels on own buildings where sensible); supply chain (dialogue with selected suppliers to reduce emissions, including use of renewable energy); logistics (switching transportation from air to sea in the fiscal year and converting some fixed supply routes to electric trucks with selected partners); eco design for packaging (optimizing size, weight and material, including less GHG-intensive and mono-materials); and eco design for products (projects addressing GHG impact, focusing on alternatives to crude oil-based virgin plastic). The company states it cannot yet report the required MDR disclosures because the action plan is not formalized due to resource constraints, so actions are not yet fully quantified, scheduled or assigned. Beyond taxonomy-aligned OpEx and CapEx, it reports no further climate mitigation operating or capital expenditures. (Sustainability Statement, page 125-126)

Sartorius Stedim Biotech reports that it has not adopted any separate targets related to climate change mitigation as a Subgroup, but is targeting the objectives of its parent company, the Sartorius Group. No standalone base year, milestone years or reduction percentages are set at the Subgroup level. (Sustainability Statement, page 126)

In the reporting year around 179,188 MWh of energy were consumed: 119,868 MWh from fossil sources (66.9%), 790 MWh from nuclear sources (0.4%) and 58,530 MWh from renewable sources (32.7%). Fossil consumption comprised 0 MWh coal, 18,419 MWh crude oil and petroleum products, 43,202 MWh natural gas, 0 MWh other fossil fuels and 58,248 MWh purchased fossil electricity, heat, steam or cooling. Renewable consumption comprised 178 MWh fuel (biomass, biofuels, biogas, hydrogen, etc.), 56,532 MWh purchased renewable electricity, heat, steam or cooling and 1,820 MWh self-generated non-fuel renewable energy. The company generated 37,723 MWh of its own energy, of which 34,686 MWh (92%) was non-renewable and 3,037 MWh (8%) renewable. Energy intensity was 0.0000645 MWh/euro (net revenue basis). About 99% of the business is assigned to high climate impact sector C Manufacturing, so total energy consumption is used in the intensity calculation. Some data are estimated using local methods where meters are unavailable. (Sustainability Statement, page 126-128)

Gross Scope 1 emissions were 13,712 t CO2eq, with 0% falling under a regulated emission trading scheme. Gross Scope 2 emissions were 40,780 t CO2eq location-based and 24,402 t CO2eq market-based. The renewable electricity share covered by bundled contractual instruments was 53% (56,247 MWh); unbundled instruments were 0 MWh. Gross Scope 3 emissions were 527,796 t CO2eq, with all applicable categories reported (no significance analysis yet performed). Main categories: Purchased goods and services 215,106 t (40.8% of total), Use of sold products 112,971 t (21.4%), Capital goods 110,839 t (21.0%), Upstream transportation and distribution 42,036 t (8.0%), Employee commuting 12,155 t, Business travel 11,623 t, Fuel and energy-related activities 8,510 t, End-of-life treatment 6,115 t, Waste generated in operations 4,017 t, Downstream transportation and distribution 3,573 t and Investments 850 t. Total gross GHG emissions were 582,287 t CO2eq location-based and 565,909 t CO2eq market-based. GHG intensity was 0.0002091 (location-based) and 0.0002033 (market-based) t CO2eq/euro. Biogenic CO2 emissions were 249 t (Scope 1) and 1,064 t (Scope 2); Scope 3 not determinable. Only 7% primary data was used for Scope 3. Accounting follows the GHG Protocol. (Sustainability Statement, page 128-133)

Sartorius Stedim Biotech reports that in the reporting period it did not develop any projects for the removal or storage of greenhouse gases, nor did it contribute to any such projects in the upstream or downstream value chain. It also states that it did not purchase or plan to purchase any carbon credits during the period, so no emission reductions or removals were financed or intended to be financed by climate change mitigation projects outside the value chain. (Sustainability Statement, page 133-134)

Sartorius Stedim Biotech reports that no internal carbon pricing schemes were used or implemented in the reporting period. It states there are no internal shadow prices, CO2 fees or CO2 funds that influenced decision-making or provided incentives for implementing climate-related policies and targets. (Sustainability Statement, page 134)

Sartorius Stedim Biotech reports that anticipated financial effects from material physical and transition risks are not relevant at present, as no material risks associated with climate change mitigation were determined in the reporting year. This is consistent with the IRO-1 climate assessment, which found no assets or business activities susceptible to gross physical or transition risks over the short-, medium- or long-term time horizons. (Sustainability Statement, page 134)

Compliance with local legal frameworks and environmental protection regulations is a central component of the Sartorius Code of Conduct, which applies throughout the Group. Sartorius Stedim Biotech aims to go beyond legal requirements and minimize the environmental impact of its activities. Responsibility lies with the sites, where appropriate management systems are in place to ensure legal compliance and promote continuous improvement of environmental performance. These systems regulate the handling of hazardous substances and emergency planning for unexpected events such as sudden pollution, an accident or a natural disaster. Some systems are externally certified to the ISO 14001 standard. Suppliers are required to have an appropriate environmental protection management system and corresponding measures. The current policy is not yet coordinated and monitored group-wide. The company is working with internal and external experts to elaborate and formalize a policy that will include general management principles, guidelines and specific responsibilities. The Group aims to complete and publish the policy in fiscal 2025. (Sustainability Statement, p. 135)

The Group's environmentally sensitive sites pursue environmental protection independently and provide the necessary human and financial resources to prevent pollution caused by hazardous substances. Membrane production requires hazardous substances in larger quantities. At the sites in Goettingen, Germany and Yauco, Puerto Rico, distillation plants enable almost full recycling of solvents from production wastewater for own reuse; unrecycled solvents are disposed of by external service providers. Based on official approvals, purified production wastewater is discharged into the sewage system or undergoes further treatment externally. Sartorius Stedim Biotech ensures transparency locally and centrally regarding purchased hazardous substances. In line with the EU REACH Regulation or equivalent international regulations, hazardous substances are managed and customers are informed about hazardous substances in products. Supplier compliance is monitored through self-assessments and audits under the human rights due diligence system. The measures are continuous, without a specific time horizon. The company is still formalizing its measures, including strategic objectives, financial resources and effectiveness monitoring, so specific financial resources and results cannot yet be reported. (Sustainability Statement, pp. 135-136)

The company has not yet set group-wide targets related to pollution. This is due to the localized control system used to date. In formalizing the pollution prevention policy, the company is working on setting up measurable, time-bound and outcome-oriented targets, including metrics to measure effectiveness for the entire Group. The company has decided not to define group-wide targets at present, as it is concentrating on the core development and implementation of policies and actions that address the main impacts, risks and opportunities relating to environmental pollution, such as the use of hazardous substances. (Sustainability Statement, p. 136)

In the reporting year, the total amount of substances of concern under ESRS generated, used or procured during production (inflow) was 804 t, the majority of which were toxic for reproduction (670 t) or carcinogenic (126 t), with smaller amounts persistent, mobile and toxic (4 t) and specific target organ toxicity, single exposure (4 t). The outflow, meaning substances that left facilities as emissions, products or part of products or services, was 213 t, the largest proportion being carcinogenic (126 t), plus toxic for reproduction (79 t) and other classes. The difference between inflow and outflow mainly reflects that a certain solvent is sent to a recycling company after several usage cycles and then repurchased. Substances of very high concern totaled 13 t for both inflow and outflow, comprising toxic for reproduction (6 t), carcinogenic (3 t) and persistent, mobile and toxic (4 t). Definitions follow the ECHA candidate list and the CLP Regulation. As no standardized database exists, figures were estimated using the purchasing system and involve estimation uncertainty. (Sustainability Statement, pp. 136-137)

In accordance with ESRS, Sartorius Stedim Biotech will not report quantitatively on the anticipated financial effects from pollution-related impacts, risks and opportunities until fiscal 2027, as these disclosure requirements are subject to gradual phasing-in by the legislator. (Sustainability Statement, p. 138)

Sartorius Stedim Biotech describes resource use as a complex challenge for a supplier to the biopharmaceutical industry, requiring it to balance sustainability with quality, safety and efficiency. Single-use plastic products made from primary fossil feedstock, such as bags and filters, reduce contamination risk versus stainless steel systems and speed new therapeutics to market, and they account for around 70-80% of turnover. These products are usually incinerated as contaminated waste at end of life due to legal requirements, so recycling is not currently possible. The Board of Directors reaffirmed its ambitions on sustainable resource use and circular economy in early 2024, focusing on eco-design, decoupling materials from fossil feedstock, increasing recyclability and avoiding operational landfill waste. The company has not yet drawn up a formal policy with management principles, guidelines and specific responsibilities. Due to resource constraints, the Corporate Sustainability department addresses topics sequentially, with an initial focus on climate. A formal policy is being developed in consultation with industry associations, customers, suppliers and the scientific community (page 139).

Sartorius Stedim Biotech reports it is already taking numerous actions to implement its resource use and circular economy approach. It continued product life cycle assessment activities in the reporting year and derived optimization potential for the product design of selected products. It also acted to reduce raw materials consumption and waste in both the value chain and own operations. During the year it investigated the use of bio-based and recycled raw materials, applying an ISCC+ certified mass balance approach that lets sustainable properties be assigned to end products via certificates without necessarily being physically present, calculated across the production chain to ensure traceability. It began certifying certain locations to the ISCC+ standard in the reporting year. Ongoing operational waste management at some relevant production sites covers avoidance, reuse, recycling and other recovery before external disposal by contracted waste companies. The actions have no specific time horizon yet, with expected results including reduced GHG emissions and less pollution. The company is formalizing strategic goals, responsibilities and financial resources, so specific financial resources cannot yet be provided (pages 139-140).

Sartorius Stedim Biotech states it is carefully analyzing the metrics first prepared and presented under E5-4 and E5-5 in fiscal 2024 in order to identify trends and to develop and implement appropriate targets and actions. The company has not yet implemented any targets for monitoring the effectiveness of its resource use and circular economy policies and actions, citing resource constraints. In formalizing its pollution prevention policy, the company reports it is working on setting up measurable, time-bound and outcome-oriented targets, including metrics to measure effectiveness for the entire Group (page 140).

Sartorius Stedim Biotech sources a wide range of raw materials and supplies to manufacture products and packaging, in particular plastic, metal, electronic components and chemicals, plus cardboard for packaging. Materials used are mostly primary plastics from fossil sources. The company does not directly procure critical materials, though purchased electronic components such as chips, semiconductors and batteries can contain critical raw materials including lithium, tungsten and silicon metal, and rare earth metals are processed in electronic components. The total weight of technical and biological materials used to manufacture products and provide services during the reporting period was 17,206 tons, covering both production materials and packaging and additional services. The proportion of biological materials from certified sustainable sourcing could not be determined for the 2024 reporting year, and the company applies the first-three-years facilitation rule to disclose value chain information later. The weight of reused or recycled secondary materials used was 5,210 tons, equal to 30% of total materials used. Metrics rely on material master data and net weights multiplied by purchase quantities, with some estimation for the upstream value chain (pages 140-141).

Sartorius Stedim Biotech categorizes resource outflows into products and waste, with main product categories being consumables and instruments. It does not currently manufacture products explicitly designed on circular principles, and a large part of the portfolio, consumables, is intended for single use and disposal due to legal quality requirements. Electronic products are repairable and durable, and under the WEEE Directive 2012/19/EU old EU appliances are taken back for recycling. Expected durability varies by product group: instruments last 9 years on average and larger biopharmaceutical devices up to 15 years; the industry average is not known. Products had an estimated recyclable content of 12%, relating to the instruments category where adhesive joints are largely avoided, and 21% of packaging is made from recyclable materials. Operational waste amounted to 7,313 t in the reporting year, of which 3,843 t (52.6%) were diverted from disposal and 3,470 t (47.4%) were directed to disposal. Non-recycled waste amounted to 3,470 t, or 47.4% of total waste. None of the waste is radioactive (0%) (pages 141-143).

Sartorius Stedim Biotech reports that anticipated financial effects from resource use and circular economy-related risks are not relevant for the company at present, as no material risks associated with resource use and circular economy were identified in the reporting year (page 145).

Sartorius Stedim Biotech reports total operational waste generated of 7,313 t in the reporting year. Of this, 3,843 t (52.6%) were diverted from disposal and 3,470 t (47.4%) were directed to disposal. Waste diverted from disposal comprised 372 t hazardous waste (0 t reuse, 372 t recycling, 0 t other recovery) and 3,471 t non-hazardous waste (23 t reuse, 3,448 t recycling, 0 t other recovery). Waste directed to disposal comprised 1,374 t hazardous waste (1,237 t incinerated, 0 t landfilled, 137 t other disposal) and 2,095 t non-hazardous waste (639 t incinerated, 678 t landfilled, 779 t other disposal). Non-recycled waste amounted to 3,470 t, accounting for 47% (47.4%) of total waste. By composition, hazardous waste totaled 1,747 t (all other hazardous waste; 0 t radioactive) and non-hazardous waste 5,566 t, split into residual waste 1,424 t, plastic waste 1,157 t, paper waste 1,090 t, waste wood 814 t and other waste 1,081 t (pages 142-143).

Sartorius Stedim Biotech reports identifying actual positive impacts on its workforce that boost satisfaction, loyalty and retention, covering secure employment, working time, adequate wages, social dialogue, freedom of association, works councils, collective bargaining, work-life balance, gender equality and equal pay, training, employment of persons with disabilities, and diversity. Potential negative impacts were identified around health and safety and workplace violence and harassment. Core policy components include the Sartorius Code of Conduct and position papers on Labour and Social Standards and on Workplace Health and Safety, plus a policy statement on respect for human rights referencing the Universal Declaration of Human Rights, the UN Guiding Principles, the OECD Guidelines and the ILO Declaration. The policy statement covers human trafficking, forced labour and child labour, and is publicly available in English. The Corporate Sustainability department owns the position papers and the human rights declaration, while operational management handles implementation. Monitoring uses a three lines model with a Human Rights Officer reporting to the Audit Committee and Board at least annually. The company excludes discrimination on grounds including race, gender, sexual orientation, disability, age and religion, but currently has no specific policy commitments on inclusion or positive action for vulnerable groups (pages 146 to 148).

Sartorius Stedim Biotech reports maintaining constant dialogue with its workforce through an employee survey conducted every six months and year-round employee appraisals led by managers. Works councils have been set up in several Group companies and cover a large proportion of the workforce, enabling participation at operational level. The Group Works Council is involved in discussions on workforce impacts arising from reducing GHG emissions and transitioning to greener, climate-neutral operations. Findings from surveys and employee dialogues feed into the human rights due diligence system, and corporate functions integrated in that system are in day-to-day contact with the workforce, allowing workers' interests to be incorporated when identifying material impacts or agreeing management actions. The Board of Directors holds primary responsibility for taking employee interests into account and ensuring results are incorporated into the company concept. The company notes it has not yet concluded a Global Framework Agreement or comparable agreement with workers' representatives on human rights, and that work is underway on an approach for checking the effectiveness of the due diligence system, including employee involvement. Further information on stakeholder dialogue is provided under ESRS 2 SBM-2 (page 148).

Sartorius Stedim Biotech reports that it will take immediate remedial action in substantiated cases where it has caused or contributed to material negative impacts on its own workforce. There were no substantiated cases in the reporting year and no remedial action was required. The complaint system allows people inside or outside the company to report breaches of laws, standards, regulations and internal guidelines. Various round-the-clock reporting channels are provided, usable in multiple languages and anonymously if preferred, and accessible via the intranet and the public website. The Compliance team can also be contacted in person, via a telephone hotline, by email or through the whistleblower system. The publicly accessible Rules of Procedure for Whistleblowers explain how the process works and how whistleblowers are protected, with confidentiality and protection against retaliation assured, including for workers' representatives who use the channels. Complaints handling is managed by the trained Compliance team, which monitors submitted complaints and tracks implementation of remedial action. All reported cases are documented, reviewed and tracked to ensure the effectiveness of the channels and actions taken (page 148).

Sartorius Stedim Biotech reports actions to manage impacts, risks and opportunities related to its own workforce, partly oriented to local site conditions and not standardized Group-wide. The company states it cannot yet report the required MDR-A disclosures because the action plan has not been formalized due to resource constraints, so actions are not yet fully quantified, scheduled or assigned. Actions cover occupational safety, health and work-life balance, including hazardous substance management, ergonomic equipment, therapeutic help for stress and mental health (not available at all sites), and flextime and hybrid working. Diversity actions include mandatory manager training on unconscious bias covering diversity, gender equality and employment of people with disabilities. Adequate wages are based on fair market pay, with collective agreements in several countries. Social dialogue is supported through global surveys and employee bodies. Training includes mandatory annual performance reviews and local production training. Effectiveness is monitored through employee surveys and metrics such as fluctuation, sickness rate, training and accident figures. The company is a member of the Pharmaceutical Supply Chain Initiative (PSCI), with voluntary PSCI audits conducted annually at five risk-selected sites. HR and EHS&S departments are in charge; detailed resource disclosures cannot yet be provided (pages 149 to 151).

Sartorius Stedim Biotech reports that it has not yet defined any Group-wide, measurable, outcome-oriented targets for managing material negative impacts or advancing positive impacts concerning its own workforce. The company explains that its initial focus is on formalizing a Group-wide policy, specific actions and concrete responsibilities that will provide the basis for corresponding targets and metrics. During the fiscal year, the Group conducted a survey of the current status of relevant metrics to establish a sound data basis. It states it is continuously moving forward with the process for defining targets, working closely with employees and in consultation with worker representatives to ensure future targets meet the actual needs and interests of the workforce. Targets related to material risks and opportunities were not relevant, as no risks and opportunities were identified in the reporting period (page 151).

As of December 31, 2024, Sartorius Stedim Biotech had 9,901 employees (headcount), equating to around 9,766 full-time equivalents. By gender, 61% were male (6,015) and 39% female (3,886), with 0 in the other or not disclosed categories. Significant countries were Germany with 3,077 employees and France with 1,409. A total of 9,271 employees held permanent contracts (5,644 men, 3,627 women) and 630 were temporary (371 men, 259 women); the company had no non-guaranteed hours employees. By region, permanent contracts numbered 6,489 in EMEA, 1,745 in Americas and 1,037 in APAC, with 294 fixed-term in EMEA, 1 in Americas and 335 in APAC. Full-time employees totalled 9,409 and part-time 492. In the reporting period, 1,146 employees left the company (840 voluntary, 255 dismissal, 44 retirement, 7 death in service), a fluctuation rate of 11.2%, mainly from voluntary departures and linked to the Fit for Future program's personnel adjustment and severance measures. Gender data for other and not disclosed categories was estimated using the 2022 German census (pages 151 to 154).

As of December 31, 2024, Sartorius Stedim Biotech reports a total of 430 non-employees, reported as a headcount. These are usually temporary workers, defined as contingent workers who work for but are not employed by the company and are excluded from payroll. The company states that non-employees play an important role in its flexibility and adaptability, allowing the Group to respond to changing market demands and short-term project requirements without permanently expanding the workforce base, which it describes as crucial to maintaining efficiency and responsiveness across geographic regions. Temporary workers are primarily employed at production sites, and at the end of the year this was mainly the case in France. The metric is based on the Group-wide HR system as of December 31 (pages 153 to 154).

As of December 31, 2024, Sartorius Stedim Biotech reports that 53% of all employees were covered by collective bargaining agreements. In the two significant EEA countries, coverage was 82% in Germany and 100% in France, with agreements being country-specific. The company explains that the gap in Germany reflects employees who fall outside a collective agreement based on job characteristics or remuneration level, plus a few companies not bound by agreements. Collective bargaining coverage was 67% in the EMEA region, and outside the EEA it was 6% in APAC and 36% in the Americas, with lower coverage attributed to lower legal labour standards. In addition, 75% of all employees in the EMEA region were represented by workers' representatives at company level, with workplace representation at 100% each in Germany and France. Social dialogue is counted as the number of employees represented by a works council, with Group companies with a works council counted at 100% and those without at 0% (pages 154 to 155).

As of December 31, 2024, Sartorius Stedim Biotech reports that top management comprised 48 people, of whom 34 (71%) were men and 14 (29%) women, with no executives in the other gender or gender not disclosed categories. Top management is defined as the first and second management levels below the Board of Directors. The age distribution of the total 9,901 employees was 15% under 30 years old (1,467), 64% in the 30 to 50 age group (6,331) and 21% over 50 years old (2,103). Age groups follow ESRS definitions: under 30 covers employees aged 29.9 or younger at period end, 30 to 50 covers those aged 30.0 to 49.9, and over 50 covers those aged 50.0 or older. Metrics are based on the Group-wide HR system as of December 31, with the other and not disclosed gender categories estimated using the 2022 German census, giving slight outcome uncertainty in gender disclosures (pages 155 to 156).

As of December 31, 2024, Sartorius Stedim Biotech reports that almost all employees are paid an adequate wage in line with applicable benchmarks. The percentage of employees paid below an adequate wage was 0.10%. The benchmark for adequate wages is based on the respective statutory minimum wages of the countries in which the company operates; where a country benchmark exceeds an employee's annual contractual base salary, that employee is not counted as adequately paid. The metric is based on the Group-wide HR system as of December 31. The company notes it uses the contractually agreed base salary rather than actual salary paid, so factors such as overtime pay are not taken into account in the comparison, which can lead to inaccurate results. It states it is continuously working to improve the data and that an improvement in this case is under evaluation (pages 156 to 157).

Sartorius Stedim Biotech reports that in the reporting year most employees are covered by public programs or company benefits against loss of income due to significant life events, which under ESRS include illness, unemployment, work-related accidents and disability, parental leave and retirement. Coverage rates were 100% for sickness, 100% for unemployment, 91% for employment injury and acquired disability, 100% for parental leave and 92% for retirement. In some countries insurance is not available for all life events: there is no insurance for work-related accidents and work-related disability in Ireland and the United Kingdom. In the USA, statutory retirement insurance is only partially available, with only employees aged over 59 years who have been with the company for more than 25 years entitled. The figures are based on a survey of the consolidated Group companies as of December 31 (pages 157 to 158).

Sartorius Stedim Biotech reports that the percentage of employees with disabilities was 2% in the reporting year. The company uses applicable country-specific definitions and local guidelines to establish which employees have disabilities. The figure is compiled on the basis of the Group-wide HR system and a survey of the consolidated Group companies as of December 31 (page 158).

As of December 31, 2024, Sartorius Stedim Biotech reports that 92% of total employees attended a performance and career development review, comprising 91% of women and 93% of men. The average number of training hours per employee was 18, with women completing an average of 17 hours and men 19 hours. In the other gender and gender not disclosed categories the proportions were 0% because there were no employees in these categories. The global performance and career development review process ran from December 1, 2023 to February 29, 2024. Eligibility covers active core workforce members who joined before October 1, 2023 and remain in the Group at year end, excluding employees on leave at the process start, trainees, employees of companies acquired within the last six months, and those in countries with limited HR system access (currently 14 Sartorius companies). Figures are based on a survey of the consolidated Group companies, with outcome uncertainties noted for reviews and gender data (pages 158 to 159).

As of December 31, 2024, Sartorius Stedim Biotech reports that 35% of its own workforce was covered by a health and safety management system, including systems externally certified to ISO 45001 or a similar standard. There were no fatalities of employees or non-employee workers due to work-related injuries or ill health. The company recorded 63 recordable work-related accidents involving employees and 8 involving non-employees, giving rates of 3.6 and 11.1 per 1,000,000 hours worked respectively. There were 8 cases of recordable work-related ill health of employees. Work-related accidents and ill health resulted in 1,137 days lost of employees. The coverage rate is based on ISO certificates in the customer portal and the number of employees per certified company. Accident and ill-health figures are based on cumulative queries of the consolidated Group companies, with the accident rate based on theoretical rather than measured working hours, giving outcome uncertainty as the rate may actually be higher or lower (pages 159 to 160).

As of December 31, 2024, Sartorius Stedim Biotech reports that 90% of employees were entitled to take family-related leave. Of entitled employees, 17% took family-related leave, comprising 16% of men and 19% of women; in the other and not disclosed gender categories the percentage was 0% because there were no employees in these categories. Family-related leave includes maternity, paternity, parental and carers' leave available under national law or collective bargaining agreements, and only those with full entitlement are counted. The figures are based on a survey of the consolidated Group companies as of December 31 and gender data from the Group-wide HR system, with the other and not disclosed categories estimated using the 2022 German census, giving slight outcome uncertainty in gender disclosures (page 161).

Sartorius Stedim Biotech reports a gender pay gap of 11% in the reporting year, meaning women earn on average 89% of what men earn overall. The company notes this is an unadjusted pay gap under ESRS because factors such as function, responsibility, hierarchy level, education and experience are not included. The ratio of the total annual remuneration of the highest-paid individual to the median total remuneration of all employees was 21%, meaning the highest-paid individual earned 21 times the employee median. Total remuneration includes target amounts for basic annual salary, the 13th monthly salary and short- and long-term bonuses, reflecting annualized pro-rata gross target salary per full-time equivalent. The gender pay gap uses average gross hourly earnings, calculated as total remuneration divided by 52.14 weeks divided by planned weekly working time. Metrics are compiled from the Group-wide HR system as of December 31 and a survey of total remuneration; the company notes changes to weekly working hours during the year and unpaid periods are not reflected (pages 162 to 163).

In the reporting year, Sartorius Stedim Biotech reports a total of 15 complaints submitted in cases of discrimination, including harassment, of which 0 were substantial or partially substantiated, 0 unfounded or unresolved, and 0 still ongoing. An additional 2 complaints were submitted through complaint channels or to national contact points for Multinational Enterprises, both of which were unfounded. There were no fines, penalties or compensation payments in connection with these incidents and complaints. The company was not convicted of violating labour or human rights, was not involved in any case handled by an OECD national contact point or surveyed by the Business and Human Rights Resource Center, and reported no incidents of failure to comply with the UN Guiding Principles, the ILO Declaration or the OECD Guidelines. No severe human rights incidents such as forced labour, human trafficking or child labour were identified, and no related fines, penalties or compensation were reported (0 EUR). The metric is based on a manual aggregation of the reporting channels (pages 162 to 165).

Sartorius Stedim Biotech identified potential negative impacts in the reporting year relating to health and safety and to violence and harassment among suppliers in the upstream value chain. To ensure compliance with human rights, the company operates a due diligence system aligned with the Supply Chain Due Diligence Regulation, covering both its own workforce and value chain workers, with further detail reported in S1-1. The Code of Conduct for Business Partners sets out minimum standards for lawful and ethical conduct, referencing internationally recognized standards including the International Bill of Human Rights, the Universal Declaration of Human Rights, the OECD Guidelines for Multinational Enterprises and the ILO Declaration on Fundamental Principles and Rights at Work. The Code has been binding for new suppliers since 2022 and must also be signed by existing suppliers, requiring safe and non-discriminatory working conditions. It explicitly addresses human trafficking, forced labour, slavery, serfdom and child labour, none of which the company tolerates in its operations or supply chain, with child labour defined per the UN Global Compact and ILO principles. The Corporate Sourcing department is responsible for implementing and monitoring the policy (page 166).

Sartorius Stedim Biotech states that it ensures all processes along the value chain are analyzed and controlled so as to largely avoid and minimize impacts. The company refers readers to ESRS 2 SBM-2 for further information on its processes for engaging with value chain workers about impacts (page 166).

Sartorius Stedim Biotech reports that its general human rights due diligence process covers both its own workforce and workers throughout the value chain. For the general procedure used to remediate negative impacts and manage complaints, including the channels available for value chain workers to raise concerns, the company refers readers to its disclosures under S1-3 (page 166).

In the reporting year the Sartorius Stedim Group took several actions to support high social standards across the supply chain. It conducts supplier evaluations, assessing direct suppliers holistically by geography and industry using recognized external sustainability platforms; suppliers with a risky abstract rating or of strategic or financial importance must complete a sustainability self-disclosure. An increasing number of major suppliers were evaluated this way for social standards. Where increased risk or specific labour and human rights violations are identified, the company runs targeted training programs and works closely with the supplier to remedy problems. As a member of the PSCI, it also uses supplier audits to check high-risk suppliers on site and agree corrective and preventive measures. Expected outcomes include improved working conditions, fewer labour and human rights violations and more sustainable sourcing. Actions are continuous, monitored and documented; specific actions with clear targets and timeframes are to be developed in fiscal 2025. Corporate Sourcing is responsible, with monitoring by Corporate Compliance and the Human Rights Officer. No severe human rights incidents in the value chain were reported. The company cannot yet disclose specific resources allocated, as data collection is not yet implemented (pages 166 to 167).

In the reporting year Sartorius Stedim Biotech had not yet defined any Group-wide measurable, time-bound and outcome-oriented targets for managing negative impacts or advancing positive impacts on value chain workers. The initial focus is on further developing a policy and specific actions, after which a systematic survey of the status quo will be carried out using relevant metrics, which will then be used to develop specific targets and indicators. This is described as an ongoing process carried out in close consultation with value chain workers so that future targets meet actual needs and challenges. The company currently monitors the effectiveness of its policies and actions through regular audits carried out by an external organization accredited by the Group in accordance with the PSCI standard, with audit reports providing a basis for evaluation and continuous adjustment. Targets related to material risks and opportunities were not relevant, as no such risks and opportunities were identified in the reporting period. Under MDR-M, the company notes it did not define any metrics in relation to material value chain worker matters, as the first step focuses on developing Group-wide targets (page 168).

Sartorius Stedim Biotech describes a corporate culture built on the values of sustainability, openness and joy, which shape cooperation internally and interactions with customers, business partners and society. It emphasizes promoting openness and a speak-up culture so employees can contribute improvement ideas and raise concerns. The Group has established leadership guidelines based on active leadership, willingness to change, performance orientation and teamwork, used as a basis for regular managerial training, and its brand promise Simplifying Progress serves as an additional reference point. The company notes the current policy is not yet coordinated and monitored group-wide. Actions include communicating corporate values, which are available on the intranet and shared during onboarding, and continuing the In This Together campaign launched in fiscal 2023, a roughly three-year campaign targeting customers and current and future employees. Managers are treated as decisive in exemplifying culture, supported by mandatory managerial training and twice-yearly employee surveys. The company tracks effectiveness through the Employee Net Promoter Score (ENPS), integrated into the CEO remuneration system with a target annual average of 35 points; scores above 30 are considered very good. The ENPS fell short of target, coming to an annual average of -9.06 points in 2024 (pages 169 to 170).