PolyPeptide is a globally active contract development and manufacturing organization (CDMO) specializing in the development and manufacturing of peptides and oligonucleotides used as intermediates and active pharmaceutical ingredient (API) in therapeutic products. It also produces a range of peptides used in cosmetics. The Group mainly serves pharmaceutical and biotech companies as well as academic institutions.
The Group’s history dates back to 1952, when it began the commercial manufacturing of therapeutic peptides in Malmö, Sweden. Since then, it has manufactured over 1,000 cGMP peptides and has developed into a full-service provider with differentiated technologies and capabilities to manufacture the most complex and innovative peptides. In the United States, the offering includes neoantigen peptides to support personalized cancer therapies. In 2021, the Group added oligonucleotides to its offering given the increasing relevance and substantial R&D investments in this therapeutic modality.
The main business of PolyPeptide is providing expert knowledge in peptide- and oligonucleotide-based API development and manufacturing along the entire life cycle of a drug, supporting initial and clinical phases, as well as commercialization. In the spirit of “start here – stay here”, the Group serves its customers across three business areas, Custom Projects, Contract Manufacturing and Generics and Cosmetics.
In the Custom Projects business area, PolyPeptide generally supports customers in the pre-clinical through clinical stage development with flexible supply. The Group’s pipeline of active custom projects, in particular the projects in the late stage of phase III clinical development, is seen as a driver of growth over the mid-term, as projects shift from development to commercialization. In the Contract Manufacturing business area, peptides and oligonucleotides are manufactured for approved commercial stage therapeutics, at scale, in commercial batches. In the Generics and Cosmetics business area, peptides are manufactured that are either off-patent or used in cosmetics.
The Group operates six cGMP certified sites in Europe, the US and India, adhering to stringent production standards and product quality specifications. Across the business areas, PolyPeptide provides complementary services, including process and analytical development as well as regulatory support.
The Group’s customer relationships are typically long-term in nature, as the Group provides its services in a “start here – stay here” philosophy along the entire life cycle of a drug. It applies a cost-based pricing model throughout its areas of activity and within the framework of master service or commercial supply agreements. As part of its integrated strategy, the Group pursues the continued harmonization of its processes, systems and organization and plans to accelerate the standardization of its operational processes across sites. This will enable it to leverage its manufacturing footprint to the benefit of customers and to strengthen its resilience.
For further details on the footprint and the business model of the company, refer to the chapter Profile.
According to an estimate by PolyPeptide based on third-party market reports published in 2022, the peptide therapeutics market is estimated to grow with a compound annual growth rate (CAGR) of around 10% to approximately USD 65 billion by 2027, driven by, among other factors, the increasing number of expected approvals of new peptide-based therapies and the growth of underlying patient populations. Therapeutic areas continue to broaden and include metabolic disorders, oncology, infectious diseases, orphan diseases, cardiovascular, neurology or gastro-enterology applications. As at the end of 2022, circa 81 peptide-based therapies were approved by the US Food and Drug Administration (FDA), with approximately 250 in clinical development (phases I to III) and approximately 500 in pre-clinical development.
Compared to the market for peptide-based therapeutics, the market for oligonucleotide-based therapeutics is more nascent, but faster growing. Based on market reports published in 2022, PolyPeptide estimates this market to grow with a CAGR of around 18% to USD 9 billion by 2027. As at the end of 2022, circa 15 oligonucleotide-based therapies were approved by the FDA, with approximately 190 in clinical development (phases I to III) and approximately 700 in pre-clinical development.
The Group’s mission is to help customers develop products, secure regulatory approvals and successfully launch and commercialize their products in the market, while being flexible to adapt to the inherent uncertainties of drug development. Building on its core values of “Innovation”, “Excellence” and “Trust”, PolyPeptide aims to be the preferred long-term partner for all its customers, who typically expect their CDMO partners to have deep operational experience and scientific knowledge, coupled with a relentless focus on quality and a high delivery performance.
As a multinational company with 1,219 employees at the end of 2022, PolyPeptide fosters an agile, open and collaborative work environment. In an increasingly competitive labor market, the Group relies on a qualified and engaged workforce to closely collaborate with customers and to ensure a high delivery performance. Attracting the right talent and retaining it, also through appropriate human capital development, is essential for PolyPeptide to grow its business and to implement its integrated strategy.
The integrated strategy of the Group is articulated around four priorities:
Customers first: The Group strives to maintain a high level of customer satisfaction across all relevant dimensions, including scientific expertise, product delivery, customer service, quality, project management and execution. It serves a growing number of customers and continuously invests in its infrastructure, its processes and its workforce to meet customer expectations.
Drive innovation: The value generation of the Group is closely linked to its leading capabilities in providing its products and services effectively, efficiently and responsibly. To that end it maintains a holistic innovation agenda to ensure its manufacturing and analytical capabilities stay at the forefront of technology. In particular, the Group collaborates actively with various universities, start-up companies and scientific institutions to access innovative technologies. An important element is the Group’s ambition to implement green chemistry processes to reduce the environmental impact from manufacturing activities.
Go for growth: PolyPeptide aims to continuously build its high-quality API custom projects pipeline and to serve its customers throughout the life cycle of their products. Given the strength of its late-stage custom projects pipeline, the Group continuously optimizes the utilization of its production infrastructure while building additional capacity to meet expected growth. Upcoming patent expiries provide opportunities to further develop the peptide generics API business. With the decision to enter the emerging market for oligonucleotide-based APIs, the Group aims to address unmet needs of customers, thus unlocking an additional avenue of growth.
Collaborate as “OnePolyPeptide”: The Group maintains a program to continuously optimize internal collaboration, seeking the right balance between local entrepreneurship and global coordination. PolyPeptide seeks to reinforce, continuously improve and harmonize processes, systems and platforms across the Group in areas including, for example, digitalization, automation, cybersecurity, talent management, vendor qualification, risk management and quality systems.
Recognizing the importance of environmental, social and governance (ESG) criteria as part of the daily business conduct, PolyPeptide adheres to fundamental principles of business ethics, corporate responsibility, and compliance. The Group thereby pursues a holistic approach to sustainability that includes reducing its environmental footprint, promoting continued improvement towards business excellence as well as strengthening the company as an employer of choice. It believes that the integration of material ESG topics into its strategy is the most effective way to meet both business needs and stakeholder expectations.
For the visualization of the Group’s integrated strategy, refer to the chapter Profile and for the progress report on its ESG agenda to the chapter Corporate Responsibility.
Scorecard and financial aspiration
The Group maintains a global balanced scorecard for supporting the implementation of its strategic agenda and operational plans and for executive compensation purposes (see Remuneration Report). In addition to the financial targets for revenue and adjusted EBITDA for a given period, the balanced scorecard includes quantitative goals for non-financial criteria. They are annually approved by the Board of Directors and include “on-time-in-full” (OTIF) delivery performance, quality, employee turnover, Environment Health & Safety (EH&S), green chemistry and critical project execution.
In line with the Group’s accelerated capital deployment program for growth launched in 2021 and the increase in the workforce in 2022, the Group aims to consistently grow revenue over the mid-term with a progressive adjusted EBITDA margin.