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:

4.1Product 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 API material to the market once approved by regulatory authorities. 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 relentless 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 with product development, 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 of 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 2023

Excluding the contribution of revenue associated with the coronavirus pandemic, PolyPeptide recorded growth of 36.6% in 2023, exhibiting peptide-driven momentum emerging from its active custom projects pipeline. The Group thereby benefited from the robust customer demand and from its capacity expansion efforts, which it continued during the reporting period with capital expenditures of EUR 54.9 million and an increase of its work force by 5.5% average full-time equivalents (FTEs).

Throughout 2023, PolyPeptide remained committed to meeting the needs of its customers. It phased out the bulk of its coronavirus-related business, which together with the peptide-driven momentum resulted in a shift within the revenue mix. In a tougher funding climate during 2023, the Group observed some customers adjusting their drug development priorities, particularly for early-stage projects in the second half of the year. With 35 (2022: 47) custom projects acquired during 2023 with existing and new customers, and with other projects being completed, discontinued, or paused, the active custom projects pipeline at the end of 2023 included 204 (220) active custom projects, with 29 (30) projects in phase III and 41 (37) projects in phase II of clinical development, reflecting the progression of the later-stage projects.

In 2023, the Group also continued to strengthen its offering for maturing peptide-based API’s, submitting 6 Drug Master Files for Generics (Gx) in new markets and 14 new authorizations for customers to reference PolyPeptide’s Gx filings.

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 2022 and 31 December 2023.

In the context of revenue growth and the challenges associated with increased manufacturing volumes during 2023, the overall on-time-in-full delivery performance (OTIF) was 85% (2022: 92%). The net promoter score (NPS), which results from interviews with over 100 customers as part of PolyPeptide’s annual customer survey, was 62.5 in early 2024 (early 2023: 70), still considered strong (scale range from -100 to 100). To ramp up and further strengthen its capabilities, the Group launched and partly implemented targeted organizational changes and process improvements in 2023.

PolyPeptide has undergone 2 regulatory and 66 customer GMP audits in 2023, 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.

4.2Green 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 business strategy with a vision of positioning itself at the forefront of environmental sustainability in its area of activity. Innovation 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, its Green program continues its focus 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 chapter below).

In 2023, the Group updated its global EHS policy statement, under which it pursues the implementation of an integrated EHS management system, including the implementation and certification of the EHS management systems at all manufacturing sites under ISO 14001. As of the reporting date, four of the six manufacturing sites had been ISO 14001 certified.

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 the sustainability in manufacturing. This includes projects in different stages of development, partly 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.

Efforts 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. A new research initiative was launched in 2023 to boost the volumetric capacity of the solid phase reactors by a chemical modification of the resin support.

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 2023

To reduce solvent (particularly dimethylformamide (DMF)) consumption in upstream processes, in 2023, the Group broadened the application of its washing concept by percolation also to smaller manufacturing equipment. In 2023, the Group’s overall solvent consumption was 2.6 metric tons relative to kg manufactured products³, 23.5% lower than in 2022 (3.4 metric tons/kg), benefitting from the systematic application of its innovative washing concept. Percolation deployment in 2023 was 84%, defined as kg of DMF used by solid-phase peptide synthesis (SPPS) projects with percolation implemented, relative to the overall DMF consumption of all SPPS projects.

Efforts to replace DMF with greener solvents were continued with a specific focus on process performance and robustness. PolyPeptide resolved technical challenges related to precipitation by replacing the coupling agent used in production, securing the scale up and the reliability of the process. The use of greener solvents as an alternative to DMF was integrated in several development projects in 2023, during which 12.5% of new development projects started with green solvents⁴. PolyPeptide is committed to continuing its efforts to replace hazardous substances and integrates respective efforts in close collaboration with customers in early stages of the drug development process.

In 2023, the Group’s overall water consumption was 137.6 ML, with the increase versus 2022 (124.7 ML) driven by the higher manufacturing time.

The Group also completed a study related to solvent recycling or downcycling, respectively, identifying suitable applications in other industries with lower quality requirements related to DMF. Together with an external partner, it also set up a pilot-scale infrastructure for the recovery of the solvent acetonitrile, used in downstream processes.

In 2023, PolyPeptide started a collaboration with a biotech company to broaden the technology portfolio with a biochemical manufacturing approach that uses less or no solvents. Furthermore, it signed a scientific collaboration agreement to support one of its innovation projects with the potential to significantly enhance the performance of SPPS.

The implementation of the Group’s Green chemistry program requires continued close collaboration across functional teams, with customers, suppliers and other stakeholders. As a consequence, in early January 2024, PolyPeptide further strengthened its respective management capabilities with the appointment of a Green Program Manager as part of the Group’s EHS organization. 

4.3Climate change mitigation

Based on the results of a Group-wide carbon footprint assessment completed in 2023 in accordance with the Greenhouse Gas (GHG) Protocol, PolyPeptide plans to formalize its climate strategy in 2024. Its approach to Climate change mitigation is closely connected to its Green chemistry efforts.

Impact

According to the carbon footprint assessment completed in 2023 with data from 2022, most of PolyPeptide’s impact on the climate occurred indirectly upstream and downstream from its operations (Scope 3). Within Scope 1 and 2, greenhouse gas (GHG) emissions differed by manufacturing site, subject to the scale of their respective activities and local conditions, such as the availability of electricity from renewable, less greenhouse gas intensive energy sources. Local conditions also impacted emissions within Scope 3, for example due to differences in the treatment of waste, including the availability of re- or downcycling capabilities. Within Scope 3, “capital goods” mainly related to the Group’s capacity expansion represented the main source of emissions, followed by “purchased goods”, primarily linked to increasing manufacturing volumes. The third relevant category within Scope 3 was the disposal of “waste generated in operations”.

Risks and opportunities

PolyPeptide is experiencing increasing customer expectations related to climate matters, new legislative and regulatory requirements, and rising energy prices over the long-term. The Group’s commitment related to Green chemistry (see above) is an integral part of the Group’s efforts to mitigate the adverse impacts on the environment and the climate, particularly from growing manufacturing volumes.

The effective mitigation of its climate impact and transparent reporting towards its stakeholders protects the Group’s customer value proposition and reputation. Reducing emissions and increasing energy efficiency may result in cost savings in the future.

Approach

PolyPeptide’s approach to Climate change mitigation and Green chemistry is designed to effectively optimize its environmental impacts. Innovation efforts at Group level are thereby combined with local initiatives.

Ambition

PolyPeptide seeks to limit its climate impact through its Green chemistry efforts and by continuously increasing energy efficiency as well as enhancing the share of renewable, less greenhouse gas intensive energy in its energy mix. Based on the Group-wide carbon footprint assessment completed in 2023, the Group will develop and launch a greenhouse gas emission reduction program in 2024, on which it plans to publicly report in 2025. 

Policies and commitments

PolyPeptide plans to formalize and to deploy a climate strategy in 2024 with actionable plans for each manufacturing site, consistent with Switzerland’s ambition under the Paris Climate Agreement. The Group is subject to the Swiss ordinance on climate disclosures brought into force as of the beginning of 2024, which provides for the binding implementation of the recommendations of the Task Force on Climate-related Financial Disclosures (TCFD). Consistent with these requirements, the Group plans to publish its first climate report as integral part of its Annual Report in 2025.

In 2023, PolyPeptide updated its EHS Group Policy Statement, incorporating the commitment to limiting its climate impact by increasing the part of renewable, less greenhouse gas intensive energy used for its manufacturing activities, continuously enhancing energy efficiency, and implementing a CO2 reduction program. The EHS Group Policy Statement also includes commitments related to applying the principles of green chemistry and to promoting circular waste management (see section 4.2 Green chemistry).

As part of its commitment, the Group participates within the framework of CDP’s climate change program, scoring a “B-" rating⁵ in 2023, and improved versus the “C” rating achieved in 2022. This complements the sustainability rating by EcoVadis, where PolyPeptide strives for a Group-wide rating, building on the existing “bronze” and “silver” ratings for the manufacturing sites.

Responsibilities

The oversight of Climate change mitigation at the Board level rests with the Audit and Risk Committee. Responsibilities for implementation are delegated to the Director Global EHS, who reports to the Global Director Operations. The Global Director EHS coordinates relevant climate-related matters with the Green Steering group and leads the EHS managers at the manufacturing sites, who are part of the local leadership teams, also reporting to the corresponding Site Director.

Management of impacts, risks and opportunities

With the Group-wide carbon footprint assessment completed in 2023, the Group gained comprehensive insights into the drivers and composition of its greenhouse gas emissions, also for each of the manufacturing sites and the differences between them. The findings serve as a base to define global and local initiatives as part of the formal climate strategy to be prepared and approved in 2024 and to be implemented over the coming years. The Group will thereby build on local experience and knowledge. For example, the Braine site joined a regional initiative to support Belgium’s strategy against global warming. A long-term action plan was implemented with goals set for 2023 versus the baseline from 2010, which the site in Braine over-achieved, thereby improving energy efficiency by more than 20%⁶.

A focus of PolyPeptide will be on technical innovation in the context of Green chemistry, which will require infrastructure investments and enhanced process standardization. The Group thereby seeks collaboration with its customers, as some of the concepts require their early integration into the drug development process.

Measures at the level of the manufacturing sites are subject to the scale of their respective activities and local conditions. Each site adheres to EHS requirements, possibly in combination with customized concepts, for example related to energy or waste management. Where possible, the sites strive to cover their needs for electricity from renewable, less greenhouse gas intensive energy sources, which is already the case for the two main manufacturing sites in Europe.

PolyPeptide requires its suppliers to acknowledge and comply with its Supplier Code of Conduct. This includes the commitment of suppliers to operate in an environmentally responsible and sustainable manner to minimize adverse impacts on the environment, particularly, to conserve natural resources, to avoid the use of hazardous materials where possible and to be engaged in activities that reuse and recycle. This also aims to contribute to reducing PolyPeptide’s Scope 3 greenhouse gas emissions.

Achievements and challenges in 2023

PolyPeptide progressed its efforts in 2023, finalizing its first Group-wide carbon footprint assessment as planned (see below). Based on the findings and with the improved understanding of the drivers of greenhouse gas emissions, PolyPeptide held initial workshops at the level of the manufacturing sites to identify suitable mitigating actions as part of the climate strategy to be formalized and deployed in 2024.

In 2023, the Group completed the energy efficiency program at its manufacturing site in Braine, over-achieving set goals according to the 2010 baseline.

In 2023, PolyPeptide invested significant resources to support the gathering, consolidation and reporting of relevant information required for the carbon footprint assessment as well as the external sustainability ratings. With continuously increasing requirements, the Group continues to develop and strengthen its internal reporting infrastructure.

The total electricity consumption of the manufacturing sites in 2023 amounted to 32,239 MWh (2022: 31,398 MWh). Of this, 17,417 MWh were purchased from renewable, less greenhouse gas intensive energy sources (2022: 16,856 MWh). The Group’s overall energy efficiency improved to 16.1 MWh/kg manufactured product (2022: 22.1 MWh/kg), driven by the increased utilization of its facilities.

Building on the initial work completed in 2022 at the three European manufacturing sites, PolyPeptide completed in 2023 with external support its inaugural global carbon footprint assessment, following the GHG Protocol, for the entire Group. The Scope 3 category “capital goods” represents the main source of emissions of the Group, followed by “purchased goods”, mainly linked to the volume of solvents used in production. The third relevant category is disposal of the “waste generated in operations”, with differences between the sites mainly emerging from their wastewater management.

The findings in 2023 for the Group confirmed the results from the footprint assessment conducted in 2022 for the European manufacturing sites and the importance of Green chemistry as part of the Group’s approach to climate change.

4.4Supply chain engagement

PolyPeptide relies on an international network of suppliers for goods and services. The Group actively seeks to work with them to ensure and promote sustainable business and responsible human rights practices within its supply chain. In 2023, it developed and published a Group-wide Supply Chain Policy on Child Labor to reinforce its commitment to complying with all applicable laws and regulations on Child Labor.

Impact

PolyPeptide maintains a network of over 440 direct raw material suppliers around the globe. In 2023, 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 damages 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 the direct engagement help PolyPeptide to mitigate supply chain risks, ensure operational resilience and to 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, should a supplier identify 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 safeguard and to promote responsible human rights practices by implementing and continuously advancing its due diligence approach.

Policies and commitments

With its Supplier Code of Conduct, which is based on the United Nations Global Compact and has been in force since 2017, PolyPeptide took a proactive approach to supply chain engagement. The document 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 2023 to reflect developments in Swiss law as well as its continued efforts on corporate responsibility. The amended supplier approval process now 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 CFO. 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 2023 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 first analysis in 2023 in relation to Child Labor (as defined in its Global Supply Chain Policy on Child Labor). PolyPeptide came to the conclusion 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 2023 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 2023

In 2023, PolyPeptide strengthened its supply chain engagement by rolling out its updated Supplier Code of Conduct and the new Global Supply Chain Policy on Child Labor, which was accompanied by internal communications and training.

PolyPeptide introduced 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 the risk-based prioritization.

As part of its due diligence process, PolyPeptide uses the services of an external 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. With regard to human rights and/or Child Labor issues, no violations were detected as of 31 December 2023. 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.

4.5People

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 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 result in fines, harm PolyPeptide’s reputation 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 protect 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 trainings in compliance with GMP requirements 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. 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 & 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 Operations. 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, two of the manufacturing sites have been issued an ISO 45001 certification. Through a targeted gap analyses, PolyPeptide plans to expand the ISO 45001 certification program to further sites including by sharing of best practices across the Group and continued harmonization between the manufacturing sites.

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 2023

With continued business growth, PolyPeptide increased its employee base by 5.5% average FTEs in 2023. 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 2023, the Group incurred eleven lost time injuries (LTI) (2022: 11), resulting in 0.14 lost working days per employee (2022: 0.8). As part of PolyPeptide’s commitment, the Group continued in 2023 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.

The Group progressed in 2023 with the implementation of its EHS agenda towards an ISO 45001 and expects additional manufacturing sites to be certified in 2024. It updated its EHS Group Policy Statement to anchor its aspirations across the manufacturing sites.

More than 1,000 employees took part in the employee engagement survey 2023, yielding a participation rate of 89% (2022: 74%). The overall engagement score was 3.6, on a scale from 1 to 5, with 5 being the highest and 1 being the lowest (2022: 3.7). The survey revealed that “relationships with colleagues and managers” and “meaningful participation” as strengths of PolyPeptide’s workplace culture, while “feedback and communication”, “workplace and tools”, and “health” scored lower. The specific results of the engagement survey were made available to the respective teams in order to further develop employee engagement.

The launch of a new Group-wide intranet platform has improved internal communications and cooperation, giving employees instant access to news, information, and tools across the Group.

In 2023, the average number of employees in FTEs was 1,202 compared to 1,139 in 2022. 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 2023 was 71% (2022: 72%), representing all employees in Belgium, Sweden, and France that are covered by collective agreements.

4.6Business 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 and compliance, 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.

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 the principles for PolyPeptide’s position 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.

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. 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 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 Corporate Compliance Committee (CCC) is responsible for promoting corporate compliance, including the protection of data privacy, 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 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 laws, rules, policies, and guidelines, subject to the nature of the issue. 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 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 cyber security. 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 cyber security 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 U.S. to combat harassment, discrimination, and retaliation.

Achievements and challenges in 2023

In 2023, the Group made continuous progress with its business ethics and compliance programs. It continued to develop the role of the CCC launched in 2022 and updated its whistleblower programs and whistleblower e-learning with active communications. It updated its Supplier Code of Conduct and released a new Global Anti-Corruption and Anti Bribery Policy as well as a Group-wide Supply Chain Policy on Child Labor to take into account changes in Swiss law and 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 2023, PolyPeptide had no significant instances of non-compliance with laws and regulations. The Group’s whistleblower hotlines received two reports in 2023, which were both withdrawn based on subsequent developments. Nevertheless, the matters were investigated under the direction of external specialists and could not be substantiated. The reports were subsequently closed and summarized to the Executive Committee and the Audit and Risk Committee.

Comprehensive efforts were undertaken to refine the Group’s approach to ESG in compliance with new and emerging legal requirements.

There were no legal actions during the reporting period regarding anti-competitive behavior or violations of anti-trust, pending or otherwise. There are also no incidents of corruption and, consequently, no responding actions to be reported.