Regulations and Compliance

The Company recognizes the importance of non-financial factors in creating long-term financial value, which involves identifying and mitigating aspects of economic activities that undermine non-financial value, as well as identifying and seizing opportunities to create the long-term value. We are dedicated to conducting our business in a safe and environmentally sustainable manner as part of our commitment to not only improve the lives of patients we hope to serve, but also to positively impact our stakeholders.

The Company encourages the recently increased regulation in this area and does its utmost to comply with applicable regulations to the best of its ability. Currently, we are subject to the Directive 2014/95/EU of the European Parliament and of the Council of 22 October 2014 amending Directive 2013/34/EU as regards disclosure of non-financial and diversity information by certain large undertakings and groups (NFRD), as implemented in Dutch law and the Regulation (EU) 2020/852 of the European Parliament and of the Council of June 18, 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 (EU Taxonomy Regulation) and ancillary delegated regulations. For the financial year ending December 31, 2024, the Company will be subject to Directive (EU) 2022/2464 of the European Parliament and of the Council of December, 14 2022 amending Regulation (EU) No 537/2014, Directive 2004/109/EC, Directive 2006/43/EC and Directive 2013/34/EU, as regards corporate sustainability reporting (the CSRD), as well as the draft Dutch legislation which will become effective to implement same. In conjunction with its advisors, the Company commenced its preparations for CSRD reporting readiness during the course of mid-2023, including a detailed analysis to confirm the scope of additional disclosure which will be required to be made by the Company and updating the Company’s materiality assessment to bring in line with the double materiality approach contemplated by the CSRD (i.e., analyzing the impact of the Company’s business on society and the environment, but also analyzing how sustainability related matters affect the business of the Company). Reporting under the CSRD represents a significant increase to sustainability reporting when compared to the requirements of the NFRD. The Company will report under the CSRD for the first time in its next annual report.

In this section, we make all disclosures required for our compliance with NFRD and the EU Taxonomy Regulation, and ancillary legislation and guidelines applicable to us. In addition to the non-financial disclosures made in this Annual Report, we have published a separate and dedicated report on ESG in 2023, of which an updated version will be published on or around the same date as this Annual Report, in which we give more context as well as additional, voluntary disclosures on ESG and related subjects.