As part of our financial disclosure we report revenue from our custom 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 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 on-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 & toxicological studies;
phase I and phase II projects includes GMP manufacturing of the API for phase I and II clinical trials, including stability studies, process and analytical development as well as regulatory documentation;
phase III projects includes GMP manufacturing of an API for the use in phase III clinical trials, including process validation (manufacturing of PPQ batches) and analytical methods validation as well as regulatory documentation (NDA filing support).
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 at 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.).