To report on its material ESG topics, PolyPeptide pursues a structure that allows for integration of the GRI standards’ requirements as well as regulations of applicable jurisdictions. For each material topic, PolyPeptide describes significant risks and opportunities for its business as well as impacts on sustainable development. Moreover, PolyPeptide provides details on its management approach, including selected metrics. For some of these metrics, internal qualitative and quantitative targets have been defined and will be further refined for potential future disclosure, as the Group advances its ESG efforts.

Pursuant to the CO, the Report on Non-Financial Matters must cover environmental matters, in particular the CO2 goals, social issues, employee-related issues, respect for human rights, and combating corruption. As part of the materiality analysis, PolyPeptide identified the material ESG topics, considering their relevance for its business as well as the CO requirements. The six ESG topics identified as material for PolyPeptide can be categorized under the non-financial matters as follows:

4.1 Product responsibility

PolyPeptide’s mission is to help its customers develop products, secure regulatory approvals, and successfully launch and commercialize their products. Through its network of six GMP-certified manufacturing sites on three continents, PolyPeptide strives to meet customer requirements in terms of quality, quantity, and time.

Impact

With its expertise in the development and manufacturing of peptide- as well as oligonucleotide-based active pharmaceutical ingredients (API) and intermediates, PolyPeptide supports the drug innovation efforts of its customers and ensures a reliable supply of material. Its active custom projects and commercial projects portfolio, including generics, covers a broad range of therapeutical areas to the benefit of millions of patients. Its manufacturing and quality processes are designed to protect their safety.

Risks and opportunities

The drug development and manufacturing process contains inherent technical and business risks along the entire life cycle of a product. Flawed operational processes and controls may result in a low delivery performance. Delays in agreed production and delivery schedules and/or lower-than-expected yields from manufacturing can adversely impact the availability of medication for patients.

Advanced process development capabilities, high manufacturing efficiency, and on-time-in-full delivery performance meet customer expectations and support their drug innovation efforts.

Approach

Consistent with applicable regulations, the six GMP certified manufacturing sites of PolyPeptide maintain comprehensive policies and procedures that cover the entire value chain of their operations. In addition, PolyPeptide continuously develops its standards to enhance Group-wide consistency and coordination. Quality is assured at every production stage following the procedures from raw material procurement, testing, and storage through production, packaging, testing, releasing, and finally, delivery of the product to the customer.

Ambition

PolyPeptide aims to be the preferred long-term partner for customers throughout the entire drug life cycle. It seeks to maintain and further develop its pipeline of active custom projects and portfolio of commercial projects, diversified across therapeutical areas. With strong process development capabilities, PolyPeptide seeks to effectively support the development of complex peptide- and oligonucleotide-based API’s and to meet the growing manufacturing volume requirements. With a focus on process design, GMP, and product quality, PolyPeptide strives for high manufacturing efficiency and on-time-in-full delivery performance as a driver for customer satisfaction and financial results.

Policies and commitments

The Group’s goal is to help customers develop products, secure regulatory approvals, and implement successful market launches to benefit patients around the world. PolyPeptide ensures regulatory compliance through its dedication to strict production procedures and product quality standards. The Group’s Quality Manual is the basis for all GMP activities. It defines which regulations are applicable and sets the basis for the policies and procedures to be followed for a specific product or service. An essential element is the Quality Plan, which includes quality performance metrics applicable across the Group.

Responsibilities

The oversight of Product responsibility at the Board level lies with the Innovation & Technology Committee. Responsibilities for implementation and day-to-day management are within the functions of the Director Global Operations and the Director Global Quality, Development, Regulatory Affairs, both reporting to the CEO.

The Director Global Operations is responsible for the Group’s manufacturing network. Each manufacturing site is managed by a Site Director, reporting to the Director Global Operations, with a Head Quality Control as a direct report.

The responsibilities of the Director Global Quality, Development, Regulatory Affairs include Quality Assurance, with a Director Global Quality Assurance as a direct report and a Head Quality Assurance at each manufacturing site.

The Director Global Quality, Development, Regulatory Affairs is also responsible for the Group’s Quality Management System, which is designed to ensure that PolyPeptide consistently provides products and services that meet customer and applicable regulatory requirements. It includes processes for continuous improvement of the organization, its products, services, as well as the quality system itself.

Management of impacts, risks, and opportunities

Compliance with policies, procedures and regulations is PolyPeptide’s main instrument to prevent or mitigate low delivery performance, potentially leading to a lack of availability of medication for patients, and to prevent or mitigate potential adverse impacts of its products. Employees and external partners engaged in the manufacturing process undergo extensive training in compliance with GMP requirements and safety regulations. The individual training includes self-study, classroom teaching, and practical on-the-job training, which is documented. To maintain training levels, PolyPeptide provides regular refresher courses.

PolyPeptide measures and tracks operational performance through a set of metrics, procedures, and internal reports. GMP nonconformities are investigated, including an impact assessment, with reviews and approvals by appropriate individuals in the quality organization. Where needed, the Group takes appropriate corrective and preventative actions. Customers are involved in the process as defined in the respective quality agreements.

With the growing manufacturing volumes from currently strong customer demand, the Group plans to continuously invest to expand its capacities, along with an increase in its workforce. To mitigate potential risks resulting from specific investments, it seeks the active involvement and participation of customers. PolyPeptide is also developing its organization to advance its capabilities.

Achievements and challenges in 2024

PolyPeptide recorded growth of 5.1% in 2024, reflecting the trend towards commercial revenue as well as the progression within its active custom projects late stage development pipeline. Commercial revenue increased by 31.8% and development revenue declined by 23.5% versus 2023. The revenue shares related to large pharma customers as well as metabolic diseases and oncology slightly increased.

The Group completed during 2024 its capital expenditures investment cycle 2021-2024 with capital expenditures of EUR 87.8 million in 2024. Over that period, it increased its work force by 7.4% average full-time equivalents (FTEs).

Throughout 2024, PolyPeptide remained committed to meeting the needs of its customers. With 29 (2023: 35) custom projects acquired during 2024 with existing and new customers, and with other projects being completed, discontinued, or paused, the active custom projects pipeline at the end of 2024 included 201 (204) projects, with 32 (29) projects for phase III and 38 (41) projects for phase II of clinical development. The number of the later-stage commercial projects supported during 2024 was 65 (64).

In 2024, the Group also continued to support its customers for maturing peptide-based API’s. PolyPeptide submitted three Drug Master Files for Generics (Gx) in new markets (2023: 6) and gained 41 new authorizations for customers to reference PolyPeptide’s Gx filings (2023: 14).

Revenue structure by therapeutical areas in %¹

Revenue structure by customer type in %¹

Revenue structure by business area in %¹

Number of active custom projects¹

1 Approximate splits per 31 December 2023 and 31 December 2024.

PolyPeptide continued its growth journey, which included the scale-up of multiple programs with complex molecules and the start of the ramp-up of new manufacturing assets. In this context, the overall on-time-in-full delivery performance (OTIF) was 83%, comparable to 2023 (85%).

Following industry trends, for 2024 PolyPeptide discontinued reporting on the net promoter score (NPS). Going forward, PolyPeptide will put enhanced focus on individual business reviews with customers to align with their needs and ensure satisfaction.

PolyPeptide has undergone five regulatory and 46 customer GMP audits in 2024, and its audit performance has generally remained strong. Continuous improvement is facilitated by the resolution of audit comments, where appropriate actions are taken in close collaboration with customers and authorities.

4.2 Green chemistry

PolyPeptide is dedicated to applying relevant principles of green chemistry to mitigate the adverse impacts on the environment from its manufacturing activities. The Group pursues comprehensive innovation efforts to reduce, recycle, replace, or avoid hazardous solvents used in production.

Impact

The manufacturing of peptide- and oligonucleotide-based API’s requires significant amounts of raw materials, including solvents and water. To improve environmental sustainability, PolyPeptide maintains a comprehensive Green program to reduce, recycle, replace, or even avoid altogether hazardous solvents used in production. The Group’s experts regularly publish on the subject in scientific journals and actively collaborate to advance the industry and to make the manufacturing of patient’s medications more sustainable.

Risks and opportunities

The use of hazardous chemicals in the manufacturing process could potentially harm employees’ health, communities, and the environment. Strict EHS procedures and promoting green manufacturing practices against the backdrop of growing manufacturing volumes help to protect employees, the environment and safeguards communities as well as PolyPeptide’s reputation.

Continuously emerging legal and regulatory requirements along with rising costs for raw materials and energy may adversely impact PolyPeptide’s competitiveness. Its market position could deteriorate if competitors systematically adopt more sustainable manufacturing practices compared to those implemented at PolyPeptide. Adopting innovative manufacturing practices meets the expectations of PolyPeptide’s customers and helps to strengthen the Group’s competitive position and protect its profitability.

Approach

PolyPeptide uses its Green program as a fundamental element of its strategy to be the most innovative CDMO with a vision of positioning itself at the forefront of environmental sustainability. Efforts are coordinated by the Group’s innovation and technology team with implementation efforts by the manufacturing sites.

Ambition

Spearheaded by the Group’s global innovation and technology team, the Green program focuses on the reduction of the quantity of solvents and reagents used relative to manufacturing volumes, the replacement of hazardous chemicals by greener alternatives and the development of solvent recycling opportunities. To promote the use of its innovative technical capabilities, the Group seeks to collaborate with customers in the early product development phase and continues to upgrade its manufacturing infrastructure accordingly.

Policies and commitments

PolyPeptide maintains a Green Master Plan, which was refined during 2023 under the supervision of the Innovation and Technology Committee of the Board of Directors. By striving for the optimized use of chemical substances, the plan also helps to reduce PolyPeptide’s impact on climate change (see separate Climate Report).

Also in 2023, the Group updated its global EHS policy, under which it pursues the implementation of an integrated EHS management system at all manufacturing sites. This includes each site’s targeted certification under ISO 14001 (environmental management) and ISO 45001 (occupational health and safety) during 2025.

As anchored within its EHS policy statement, the Group is committed to promoting Green chemistry in projects from the early development phase, and to setting up production capacities that enable the use of Green chemistry. Furthermore, it is committed to promoting circular waste management by using processes to reduce waste, optimizing waste flows to enable their recycling and recovery, and developing solutions for solvent recycling.

Responsibilities

The oversight of Green chemistry at the Board level rests with the Innovation and Technology Committee. Responsibilities for implementation and day-to-day management are coordinated by the Green Steering group which includes all the relevant functions, including Innovation and Technology, Development, Technical Operations, Engineering, Procurement, and EHS. The Green Steering group is chaired by the Director Global Innovation & Technology, reporting to the CEO.

Management of impacts, risks, and opportunities

The reduced and optimized utilization of chemicals supports the environmental sustainability of PolyPeptide’s manufacturing activities, contributes to the reduction of the Group’s carbon footprint, and mitigates chemical risks for communities. Consistent with its strategic aspiration to lead in innovation, PolyPeptide’s global innovation and technology team maintains and systematically advances a portfolio of projects to improve sustainability in manufacturing. This includes projects in different stages of development, including those with proprietary and protected technologies as part of the Group’s intellectual property portfolio to not only enhance its competitive position, but also to generate benefits for its customers and stakeholders.

Part of the Green chemistry program is the replacement of hazardous solvents by greener substances. Several guidelines can be used to rank the greenness of the selected solvents, based on safety, health, and environmental considerations. As is customary, PolyPeptide used its reasonable discretion for the solvent classification based on its expertise and building on the guidelines published by the Chem21 Consortium. The Group follows local EHS requirements and is in regular contact with authorities.

To save solvents used in production, the Group continues to deploy its patented in-process washing concept by percolation², which was developed by the Group’s scientists. It pursues projects to advance solvent recovery, recycling and downcycling, both in upstream and downstream processes. However, concepts for recycling or downcycling depend on, among other things, the availability of specialized facilities and service providers within a reasonable distance from the manufacturing sites.

Other efforts to manage impacts, risks and opportunities include the evaluation of disruptive technologies, which, if successful, would allow increased throughput and productivity, coupled with the reduction of solvent consumption relative to the manufacturing volumes.

In addition, to progress its innovation efforts, the Group actively collaborates with customers, suppliers, academic institutions, and strategic partners. Where suitable, it shares its innovative concepts and as such helps to advance the industry and local service providers. Concepts for recycling or downcycling depend on, among other things, the availability of specialized facilities and service providers within a reasonable distance from the manufacturing sites.

PolyPeptide tracks the effectiveness of measures to reduce and optimize the utilization of chemicals through a set of metrics, procedures, studies, and collaborations.

Achievements and challenges in 2024

With PolyPeptide’s manufacturing sites in Torrance and in San Diego achieving their ISO 14001 certification in 2024, all manufacturing sites are now certified under ISO 14001. Further, in 2024, the Strasbourg manufacturing site achieved the RSPO (Roundtable on Sustainable Palm-Oil) supply chain certification for its development, manufacturing, and service activities carried out for cosmetic peptides production.

In 2024 PolyPeptide continued its efforts to further optimize solvent consumption (particularly dimethylformamide (DMF)) by further developing its washing concept by percolation in the upstream processes. Percolation deployment in 2024 remained high at 82% compared to 84% in 2023, reflecting fluctuations in the product mix.

In 2024, the Group’s overall solvent consumption was 3.1 metric tons relative to kilogram manufactured product³ (2023: 2.6 metric tons/ kilogram). The increase is driven by the evolution of the product mix in 2024 towards more complex peptide sequences that required more solvents.

Efforts to replace DMF continued in 2024 , whereby 3.1% of new development projects were started with green solvents⁴ (2023: 12.5%). The use of greener solvents is systematically considered in new development project proposals, subject to technical feasibility and customer preferences, both of which drove the year-on-year development. In 2024, PolyPeptide started the construction of a pilot-scale unit and an industrial manufacturing line specifically designed for the efficient and safe use of green solvents at its Strasbourg site, both planned to be operational in 2025.

In line with the Group’s green chemistry program and in anticipation of the future restrictions for the use of PFAS (per/polyfluoroalkyl substance), PolyPeptide advanced its research efforts for PFAS-free SPPS alternatives during 2024, identifying several viable options for industrial applications within green chemistry over the coming years. These research efforts enhanced the proprietary technology portfolio and selected findings have been shared with the scientific community⁵.

In addition to its solvent reduction and replacement efforts, the Group also continued its recycling initiatives, including an industrial offsite recycling program for solvent waste with contractors. Solvent waste is either downcycled for reuse in other industries with lower quality requirements or recycled into high-grade solvent reusable at PolyPeptide.

For the recovery of acetonitrile⁶, several pilot-scale trials were run at PolyPeptide’s site in Torrance, California, during 2024 together with an external partner and are planned to be continued during Q1 2025. If the trials are successful, PolyPeptide is considering designing an on-site recycling solution, complementing its existing off-site recycling practices at the site in Braine-L’Alleud, Belgium.

In 2024, PolyPeptide continued to advance its proprietary manufacturing technology with a research program to increase the throughput of its SPPS infrastructure by increasing the loading capacity of the resin. This included trials to assess the applicability of the concept in an industrial environment for different peptide sequences. In parallel, the academic research collaboration with partner institutions was further pursued.

PolyPeptide continued in 2024 its collaborative efforts, offering customers access to biochemical manufacturing options, complementing its synthetic capabilities.

In 2024, the Group’s overall water consumption was 177.3 ML, with the increase versus 2023 (137.6 ML) driven by the higher manufacturing volumes.

4.3 Climate change mitigation

During 2024, PolyPeptide finalized its climate strategy and transition plan, including Greenhouse Gas (GHG) reduction targets which will be submitted for validation by the Science-Based Target initiative during 2025. The Climate Report includes the Group’s disclosure on climate-related matters in accordance with art. 946b CO (see section Climate Report). 

4.4 Supply chain engagement

PolyPeptide relies on an international network of suppliers for goods and services. The Group actively seeks to work with its suppliers to ensure and promote sustainable business and responsible human rights practices within its supply chain. It has a Group-wide Supply Chain Policy on Child Labor that reinforces its commitment to complying with all applicable laws and regulations on Child Labor.

Impact

PolyPeptide maintains a network of over 430 direct raw material suppliers around the globe. In 2024, the top 100 raw material suppliers together accounted for around 90% of the total material spending. The Group’s main raw material categories constitute starting materials, solvents, reagents, and purification resins. Where feasible, PolyPeptide sources these products regionally, which benefits the environment as well as regional economies and communities. PolyPeptide actively assumes its responsibility to respect human rights, including those pertaining to Child Labor, inside its own operations and across its network of commercial partnerships. Insufficient supply chain engagement, including neglecting human rights, could have adverse effects on stakeholders along the supply chain, particularly workers and may harm the communities from which PolyPeptide sources.

Risks and opportunities

The availability of sufficient supplies is critical for PolyPeptide’s customer value generation. A lack of sufficient planning and controls within its supply chain, including a lack of procedures to ensure responsible and sustainable business practices, might lead to reputational damage and delays or shortages of critical raw materials, capital goods and services, with adverse impacts on PolyPeptide’s delivery performance and consequences for customers and patients.

The adequate diversification of sources, clear specifications and procedures, and direct engagement help PolyPeptide mitigate supply chain risks, ensure operational resilience, and promote ethical behavior and legal compliance along its value chain, ultimately preventing any harm to its reputation.

Approach

Operating within a highly regulated GMP business environment, PolyPeptide maintains procedures to approve and certify critical suppliers. With its Supplier Code of Conduct published on the corporate website, it expects its suppliers to conduct their business in compliance with applicable local, national, and international laws and regulations, contractual agreements, and consistent with internationally recognized environmental, social, and corporate governance standards. The Group commits to providing suitable support, in the event a supplier identifies practices or behaviors that fall short of these expectations.

Ambition

PolyPeptide believes that its suppliers should share its fundamental values and principles related to corporate responsibility. It expects them to conduct their business in compliance with all applicable local, national, and international laws and regulations, contractual agreements and consistent with internationally recognized environmental, social, and corporate governance standards. The Group is committed to safeguarding and promoting responsible human rights practices by implementing and continuously advancing its due diligence approach.

Policies and commitments

With its Supplier Code of Conduct based on the United Nations Global Compact and in force since 2017, PolyPeptide takes a proactive approach to supply chain engagement. The Code is divided into the five core sections Ethics, Labor and Human Rights, Health and Safety, Environment and Management systems. The Group’s suppliers are required to observe and comply with the Supplier Code of Conduct and are encouraged to review their adherence regularly.

The Group updated the Supplier Code of Conduct and published a Global Supply Chain Policy on Child Labor in 2024 to reflect developments in Swiss law as well as its continued efforts on corporate responsibility. The supplier approval process requires, inter alia, an approach to identify and assess any risk of Child Labor.

Responsibilities

The oversight of Supply chain engagement at the Board level is with the Audit and Risk Committee. Responsibilities for implementation are delegated to the Director Global Procurement, who reports to the Director Global Operations. The Director Global Procurement works with the purchasing departments that are part of each manufacturing site’s local management structure.

Management of impacts, risks, and opportunities

PolyPeptide requires its suppliers to acknowledge and comply with its Supplier Code of Conduct and the Global Supply Chain Policy on Child Labor. The instruments that PolyPeptide may use to identify and assess any risks of Child Labor in its supply chain are described in the Global Supply Chain Policy on Child Labor. The Group carries out a risk-based assessment to anticipate, avoid, or mitigate potential or actual adverse impacts associated with its supply chain.

Starting in 2023, with the support of a multinational assurance, inspection, product testing and certification company, PolyPeptide began engaging with selected high-risk tier 1 raw material suppliers through a questionnaire based on ISO 26000. Suppliers are selected using a risk-based approach, focused on any enhanced risks of human rights and Child Labor violations based on, inter alia, the UNICEF Children’s Rights in the Workplace Index. PolyPeptide may further conduct on-site as well as remote audits on a case-by-case basis to verify compliance. In the event of observations or suspicions of actual or potential violations, PolyPeptide will engage with the supplier to create a remediation plan, and in severe cases terminate the relationship.

PolyPeptide’s analysis in 2024 in relation to minerals and metals from conflict-affected areas established that PolyPeptide does not place in free circulation or process minerals containing tin, tantalum, tungsten or gold, or metals from conflict-affected and high-risk areas in Switzerland. PolyPeptide also performed its analysis in 2024 in relation to Child Labor (as defined in its Global Supply Chain Policy on Child Labor). PolyPeptide concluded that it does not offer any products or services for which there are reasonable grounds to suspect that they were manufactured or provided using Child Labor.

For further information on PolyPeptide’s analysis in 2024 in relation to conflict minerals and metals from conflict- affected areas and Child Labor, see section 6 PolyPeptide’s voluntary report on child labor due diligence in its supply chain.

Achievements and challenges in 2024

In 2024, PolyPeptide strengthened its supply chain engagement by rolling out its updated Global Supply Chain Policy on Child Labor, which was accompanied by internal communications and training.

PolyPeptide maintains a uniform supplier screening and onboarding process, starting with a search on a third-party screening interface. The process contributes to the identification of high-risk suppliers and risk-based prioritization.

As part of its due diligence process, PolyPeptide uses the services of a service provider to ensure the effectiveness of its supplier engagement. In 2023, nine selected high-risk tier 1 raw material suppliers (that are among PolyPeptide’s top 100 suppliers) started their participation in assessments, including for human rights and Child Labor issues. As of 31 December 2024, ten selected high-risk tier 1 raw material suppliers have completed the assessments. With regard to human rights and/or Child Labor issues, no violations were detected. Late 2024, five new high-risk tier 1 raw material suppliers were selected to participate in the assessments during 2025. The onboarding process with these newly selected suppliers is ongoing. During 2025, PolyPeptide plans to evaluate options for the next steps with the suppliers that have completed the assessments.

PolyPeptide is committed to expanding and continuously improving the assessment of its supply chain, with a particular focus on any potential new suppliers from high-risk areas before entering into any business relationships. At the same time, PolyPeptide is committed to the ongoing training of relevant employees on the topic of Child Labor to foster awareness within the Group and cooperation with suppliers.

4.5 People

PolyPeptide depends on its employees to run its operations in line with GMP requirements and to develop its project and technology portfolio, and its organization. The Group operates in compliance with EHS regulations and upholds strict principles for a fair, inclusive, and respectful workplace that values safety and work-life balance.

Impact

Through its international manufacturing network, PolyPeptide offers qualified job opportunities, most of which are subject to continued GMP training. The manufacturing process, especially the handling of hazardous substances, entails potential health and safety risks for employees that require specific precautions. In addition, increased production volumes can have an adverse impact on employees’ health and well-being. With its commitment to a safe and healthy workplace, the Group strives to enhance overall employee health and well-being and to prevent accidents, sickness, absences, and mental health issues. The Group continuously invests in the maintenance and growth of its local infrastructure and endorses innovation and the sharing of best practices between its manufacturing sites.

Risks and opportunities

PolyPeptide’s manufacturing processes are complex with a high level of responsibility for employees on the shop floor. Increased production volumes and associated intensified production schedules without adequate protective measures for employees’ health and well-being may lead to more accidents, sickness, absences, and mental health issues. A lack of their technical proficiency may lead to flawed delivery performance, possibly with adverse impacts on the availability of medication for patients. Staff turnover or absences increase operational risks. A lack of compliance with EHS requirements could impact financial performance, result in fines, harm PolyPeptide’s reputation, impact turnover. or impact its licenses to operate.

Adherence to GMP requirements ensures the quality of products and services, while market growth and the continued development of PolyPeptide’s organization provide individual employment and development opportunities.

Approach

Each of PolyPeptide’s manufacturing sites is GMP certified, with established HR and EHS functions as part of the local management organization. Where appropriate, Group-wide procedures ensure global coordination.

Ambition

Attracting and retaining talent with suitable qualifications is critical for PolyPeptide’s success. It strives to offer employees an attractive work environment with development opportunities, and to allow them to manage their work-life balance. It upholds strict principles for a fair, inclusive, and respectful workplace and is committed to protecting people’s health and safety by eliminating hazards and reducing risks. The Group provides training programs in line with GMP requirements and actively develops its organization to manage the expected business growth.

Policies and commitments

All employees engaged in the manufacturing process go through training in compliance with GMP requirements and health and safety regulations. The individual GMP training includes self-study, classroom teaching, and practical on-the-job training, which is documented and subject to regular refreshers.

The Group follows local EHS requirements with an initiative under way to certify the manufacturing sites under ISO 45001 by the end of 2025. Its EHS Group Policy Statement intends to protect people’s health and safety by eliminating hazards and reducing the risks inherent in PolyPeptide’s operations, by identifying and managing psychosocial risks and by creating a pleasant and safe workplace environment where people can develop.

PolyPeptide’s values and commitments are codified in its Code of Business Conduct and Ethics. While not tolerating harassment, bullying, and discrimination, the Group fosters diversity, equity, and inclusion, provides equal employment opportunities, and defends human rights and freedom of association.

Furthermore, PolyPeptide abides by applicable municipal, state, federal, and local employment regulations, including those that cover pay rates, overtime, workplace health and safety, and equal employment opportunities. Employee contracts and handbooks are provided in the local language to ensure accessibility for all employees.

Responsibilities

The oversight of People at the Board level is with the Remuneration and Nomination Committee. Responsibilities for implementation and day-to-day management are with the Chief Human Resources Officer (CHRO) and the Director Global EHS, with the CHRO reporting to the CEO and the Director Global EHS to the Director Global Engineering. They coordinate and implement Group-wide initiatives in collaboration with their colleagues with functional responsibility at the manufacturing sites.

Management of impacts, risks, and opportunities

In addition to individual GMP trainings, the Group provides employees with trainings in compliance with relevant EHS standards and protocols. Regular training is intended to ensure smooth operations, prevent accidents, and promote the health and well-being of employees, with access to medical services as appropriate.

To manage individual performance and development, the Group maintains annual performance evaluation and employee development processes. Line managers are requested to conduct suitable discussions with their team members, supported by Human Resources.

Complementing the incentive structures for its Executive Committee, the Group provides eligible employees with variable compensation, with realized pay levels subject to company performance and the achievement of individual objectives. The objectives thereby depend on the individual areas of responsibilities and typically include financial and non-financial criteria, linked to preset targets.

PolyPeptide continually monitors staff turnover, employee overtime, and absence, and takes site-specific actions where needed. Lost Time Injuries and reported workplace complaints are monitored and investigated with the appropriate remediation measures being taken. With employees leaving the Group, exit conversations or surveys are offered to collect relevant feedback.

Currently, four of the manufacturing sites have been issued an ISO 45001 certification. The certification of the two manufacturing sites in France and Sweden is expected by the end of 2025.

Occasionally, and subject to the risk assessment of new product development or construction projects, PolyPeptide conducts specific risk studies, collaborating with external specialists as necessary, to proactively identify and minimize potential threats to the health of employees or the environment.

Achievements and challenges in 2024

With continued business growth, PolyPeptide increased its employee base by 7.4% average FTEs in 2024. Significant efforts were deployed to ensure the appropriate training for new employees and to instill technical proficiency and operational best practices among the workforce.

In 2024, the Group incurred 14 Lost-Time Injuries (LTI) (2023: 11), resulting in 0.09 lost working days per employee (2023: 0.14). As part of PolyPeptide’s commitment, the Group continued in 2024 its health and safety programs at the manufacturing sites, which included awareness and practical accident trainings. In addition, the sites held practical trainings with emergency responders.

More than 1,000 employees took part in the employee engagement survey 2024, yielding a participation rate of 86% (2023: 89%). The overall engagement score was 3.6, on a scale from 1 to 5, with 5 being the highest and 1 being the lowest (2023: 3.6). The survey revealed “Relationships with Colleagues”, “Meaningful Participation” and “Relationship with Manager” as strengths of PolyPeptide’s workplace culture, while “Feedback and Communication”, “Workplace and Tools”, and “Autonomy” scored lower. The specific results of the engagement survey were made available to the respective teams in order to further develop employee engagement.

A Group-wide intranet platform has been in place since 2023, fostering internal communications and cooperation, giving employees instant access to news, information, and tools across the Group.

In 2024, the average number of employees in FTEs was 1,291 compared to 1,202 in 2023. Breakdowns of the employees by geography, job category, site, age, experience, qualification, and gender are presented in the tables below.

The number of employees covered by collective bargaining agreements by the end of 2024 was 72% (2023: 71%), representing all employees in Belgium, Sweden, and France that are covered by collective agreements.

4.6 Business ethics and compliance

PolyPeptide is committed to ethical behavior and compliance with legal and regulatory requirements. This includes a secure digital environment to protect sensitive data and business information. It requires adherence to its Code of Business Conduct and Ethics, with procedures in place to identify potential wrongdoing and misbehavior.

Impact

PolyPeptide’s commitment to ethical behavior and compliance with legal and regulatory requirements is intended to protect its assets and the interests of its stakeholders, including customers, employees, investors, and suppliers. Its efforts to instill a culture of integrity and responsibility thereby cover partners along the supply chain. PolyPeptide is focused on the needs of its customers to the benefit of patients and strives to ensure that its activities have a beneficial impact on the communities in which it operates. Violations of business ethics and compliance may jeopardize fair market structures and distort competition.

Risks and opportunities

Non-adherence to applicable laws, rules, regulations, ethical standards, internal policies and procedures, or the loss of sensitive data, may put the Group at risk of business interruptions and legal prosecution with adverse impacts on financial performance and reputation.

By demonstrating effective controls, compliance, and a strong commitment to ethical practices, PolyPeptide secures its operational performance and positions itself as a reliable, trustworthy business partner. As part of its innovation efforts, PolyPeptide continues to adapt digital solutions to strengthen operational processes, transparency, and efficiency, including a governance framework for artificial intelligence (AI).

To balance the risk of cyber security malicious events, while complying with regulatory requirements and maintaining customer trust, PolyPeptide has initiated certification of all sites according to ISO27001:2022 Information Security Management Systems. The certification process is estimated to be completed during 2025.

Approach

The Group is subject to comprehensive regulations and stringent quality processes. Its approach to business conduct and ethics is codified in its Code of Business Conduct and Ethics, published on the Group’s website.

Ambition

By requesting adherence to its Code of Business Conduct and Ethics, and with suitable internal policies and procedures, PolyPeptide seeks to ensure ethical behavior and compliance with legal and regulatory requirements. It has procedures in place to identify potential deficiencies, wrongdoing, and misbehavior, with differentiated procedures to assess and remediate infractions. 

Policies and commitments

All employees, including managers and the members of the Board of Directors, are subject to the Code of Business Conduct and Ethics, which emphasizes the Group’s commitment to ethics and compliance, sets forth the basic standards of ethical and legal behavior, provides reporting mechanisms for known or suspected ethical or legal violations, and helps to prevent and detect wrongdoing. Supplementing the Code of Business Conduct and Ethics and the Supplier Code of Conduct, the Global Anti-Corruption and Anti Bribery Policy sets out PolyPeptide’s principles for integrity and against corruption and bribery. It further provides guidance on how to recognize and deal with potential bribery and corruption issues.

Building on its core values of “Innovation”, “Excellence”, and “Trust”, PolyPeptide fosters an agile, open, and collaborative work environment with an atmosphere of honest and open communication. In addition, its whistleblower policies and procedures allow anyone to voice concerns about a possible wrongdoing confidentially and even anonymously, if desired, and without fear of reprisal.

PolyPeptide maintains a set of internal policies and procedures to ensure good corporate governance, including the Global Sanctions and Export Control Compliance Policy and Procedure, the Enterprise Risk Management Policy, the Risk Assessment and Reporting Procedure, a Disclosure Policy, and an Insider Dealing and Market Manipulation Policy.

During 2024, PolyPeptide introduced its Artificial Intelligence Policy as part of the commitment to ethical business conduct and compliance with AI regulations. The newly established governance framework, aligned with existing data privacy and information security frameworks, aims to foster ethical AI practices, transparency, accountability, and regulatory compliance. Key principles of PolyPeptide’s AI governance include ensuring patient safety, ethical application of AI models, transparency, and data security.

The Group maintains an Enterprise Risk Management framework, providing a consistent, Group-wide perspective of identified key risks, presented to, and approved by the Board of Directors. During the 2024 risk assessment process, the Group increased focus on and the integration of sustainability-related topics, ensuring that environmental, social, and corporate governance risks and opportunities as identified in the double materiality assessment process are part of the Company’s risk management and strategic planning processes. Regular internal audits focus on areas including the Group’s control environment, aligned with the strategic priorities and risks identified.

As outlined under section 4.4 Supply chain engagement, PolyPeptide also expects its suppliers to conduct their business ethically and in compliance with applicable local, national, and international laws and regulations, contractual agreements and consistent with internationally recognized environmental, social, and corporate governance standards.

Responsibilities

The oversight of Business ethics and compliance at the Board level is with the Audit and Risk Committee. Responsibilities for implementation are delegated to the General Counsel, who also holds the position of the Group’s Governance, Risk, and Compliance Officer. The Group’s IT organization is under the leadership of the Director Global IS/IT, who reports to the CFO.

The cross-functional Corporate Compliance Committee (CCC) is responsible for promoting corporate compliance, including the protection of data privacy and information security, and identifying potential violations to ethical business conduct. The Group maintains a corporate compliance program to continuously prevent and identify infractions of laws, rules, policies, and guidelines.

While the Board of Directors retains the ultimate responsibility for risk management and for determining the appropriate level of risk that PolyPeptide is willing to accept, the PolyPeptide Management Committee (together with the Audit and Risk Committee) is responsible for ensuring that the operation of the Enterprise Risk Management Framework is sound, including risk management of significant risks through the monitoring of specified actions.

Finally, the Group’s Head of Internal Audit, reporting to the Audit and Risk Committee, plays an instrumental role in ensuring adequate Board oversight with the instillment of effective, compliant, and responsible business practices. The Head of Internal Audit implements an annual audit plan, presented to and approved by the Audit and Risk Committee, and reports findings with best practice recommendations to the Audit and Risk Committee.

Management of impacts, risks, and opportunities

The Group has differentiated legal and compliance procedures in place to prevent or assess and remediate any identified infractions of applicable laws, rules, policies, and guidelines. Its Code of Business Conduct and Ethics is part of the onboarding of new employees and regular trainings, including annual e-learnings.

The PolyPeptide Management Committee, together with the General Counsel and other internal stakeholders, annually conduct a risk assessment and evaluate strategies to address the risks and opportunities identified. A risk assessment report, including the probability and consequences of identified risks, is presented to the Audit and Risk Committee and the Board of Directors annually for a deep-dive discussion.

Observations and corrective actions resulting from internal audits have defined owners and due dates, with the implementation progress of defined actions being systematically monitored and reported.

The Global IS/IT organization monitors and audits the digital environment to detect and respond to any potential threats or breaches that could compromise the confidentiality, integrity, or availability of sensitive data and business information. By providing the necessary infrastructure, software, and support, Global IS/IT supports and facilitates the digital transformation of PolyPeptide’s processes, products, and services.

The Group provides regular digital and, where suitable, on-site trainings on business ethics, compliance, and cybersecurity. Through targeted internal messaging to employees, it seeks to ensure that employees are aware and knowledgeable about relevant standards and procedures, including the whistleblower hotlines operated 24/7 by an independent third party in relevant local languages.

The results of the digital ethics, compliance and cybersecurity awareness trainings are examined for effectiveness and continued improvement. The generally positive feedback and outcomes from the Group-wide e-training efforts demonstrate good acceptance and cultural compatibility of the training programs. Some of the manufacturing sites provide further trainings, for example, in the US, to combat harassment and discrimination.

Achievements and challenges in 2024

In 2024, the Group made continuous progress with its business ethics and compliance programs. Membership of the CCC was expanded to ensure relevant cross-functional representation. PolyPeptide also introduced a governance framework for AI, including the implementation of an Artificial Intelligence Policy, with key principles to ensure an ethical approach to related risks and opportunities. The Group further updated its whistleblower e-learning with active communications. It also updated its Code of Conduct and Ethics with a focus on the topic of conflict of interest and added a new form for reporting potential or actual conflicts of interest. PolyPeptide further updated its Group-wide Supply Chain Policy on Child Labor to reflect its continued efforts to promote corporate responsibility. Further trainings included the Code of Conduct e-learning and the IT-security awareness training.

In 2024, PolyPeptide had no significant compliance violations. PolyPeptide considers significant compliance violations to be those that must be publicly reported.

During 2024, PolyPeptide continued efforts to promote and raise awareness of its whistleblower programs.

The Group received ten whistleblower reports in 2024 (2023: two). During 2024, the investigation for seven reports has been closed and summarized to the Executive Committee and the Audit and Risk Committee, with a summary to the Board of Directors. Four out of seven closed reports were partially or fully substantiated with appropriate actions taken and three closed reports were not substantiated. The investigation for the remaining three reports is still ongoing.

In 2024, there were no legal actions during the reporting period regarding anti-competitive behavior or violations of anti-trust, pending or otherwise.