As part of our financial disclosure, we report revenue from our custom development projects business area, and we occasionally make implicit or explicit reference to the underlying project pipeline as an indicator to measure operational performance. This includes the number of projects in clinical development in total or in categories. Our project count for a given period includes only projects that are invoiced to our customers. Projects with parallel activities at more than one site, or which are transferred from one site to another, or which included multiple peptides or oligonucleotides are counted as one project. The synthesis or one-time manufacturing of small quantities of peptides or oligonucleotides, mostly for research or academic use, is not considered as a project.

Our reference to

• pre-clinical projects includes non-GMP manufacturing for the lead candidate selection, and subsequent non-GMP manufacture of the selected API for pre-clinical and toxicological studies;
• phase I, phase II and phase III projects includes GMP manufacturing of the API for phase I, phase II and phase III clinical trials, including analytical method validation, stability studies, process and analytical development as well as regulatory documentation;

Active custom projects include (i) projects with ongoing manufacturing activities; (ii) projects with ongoing non-manufacturing activities (development, analytical services, regulatory, stability studies); (iii) projects with open orders in the Group’s accounting system pending to be delivered; and (iv) projects that are active on the customer’s end, but not necessarily active at PolyPeptide (i.e., when the customer is conducting pre-clinical or clinical studies, formulation studies, etc.).

Reference to “peptides” is to a chemical entity (CE) with a unique amino acid sequence regardless of production site or manufacturing process. A “pipeline peptide” is a new chemical entity (NCE) in pre-clinical or clinical phase of development and a “commercial peptide” is a NCE commercially approved on the market.

A “commercial project” relates to the manufacturing of commercial peptide or oligonucleotide. This includes therapeutic API or intermediates with regulatory approval, both for the innovator or for a generic drug manufacturer. A commercial project may also include material for diagnostic, cosmetic or veterinary purposes.

“Commercial revenue” is defined as the combined revenue of the business areas Contract Manufacturing and Generics & Cosmetics. “Development revenue” is defined as the revenue in the business area Custom Projects.

A lost time injury (LTI) is a work-related injury due to external causes that requires medical treatment and results in the loss of productive work time.

On time in full (OTIF) reflects whether a shipment / delivery is done on or before the promised shipping date (On Time) and the ordered or more than the ordered quantity is delivered (or within agreed tolerance) (In Full).