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(as VYVGART HYTRULO), Japan (as VYVDURA), the UK and all 27 EU Member States plus Iceland, Norway and Liechtenstein for VYVGART SC VYVGART HYTRULO VYVGART HYTRULO we, us or our argenx SE together with its wholly owned subsidiaries and, as applicable, its former wholly owned subsidiaries Zai Lab Zai Lab Ltd ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 Definitions | 394 Zai Lab Agreement collaboration agreement with Zai Lab Ltd, relating to an exclusive out-license for the development and commercialization of efgartigimod in Greater China Zai Lab Payments $75.0 million upfront payment under the collaboration with Zai Lab Ltd in the form of 568,182 newly issued Zai Lab shares calculated at a price of $132.0 per share, a $75.0 million guaranteed non-creditable, non-refundable development cost-sharing payment and a $25.0 million milestone payment in connection with FDA approval of VYVGART ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 Definitions | 395 Contact us via argenx.com/contact-us You can find the annual report 2023 online at reports.argenx.com/2023
Tax Treaty Convention between the Netherlands and the U.S. for the avoidance of Double Taxation and the Prevention of Fiscal Evasion with respect to Taxes and Income, dated December 18, 1992 as amended by the protocol of March 8, 2004 UCHealth University of Colorado Health UCL Universit Catholique de Louvain UK the United Kingdom UK GDPR legal framework adopted by the United Kingdom substantially equivalent to the Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016, on the protection of natural persons with regard to the processing of personal data and on the free movement of such data UPCR urine protein creatinine ratio USPTO the United States Patent and Trademark Office UT Agreement an exclusive in-license with the Board of Regents of the University of Texas System UT BoR the Board of Regents of the University of Texas System UT Southwestern University of Texas Southwestern Medical Center VIB VIB vzw VIB Agreement collaboration agreement entered into with VIB V-regions antibody variable regions VYVDURA VYVDURA VYVGART VYVGART VYVGART SC VYVGART subcutaneous VYVGART Approved Countries (i) U.S., Japan, UK, Mainland China, Canada, Israel and all 27 EU Member States plus Iceland, Norway and Liechtenstein for VYVGART for gMG, and (ii) the U.S.
Taxonomy Environmental Objectives the six objectives included in the EU Taxonomy Regulation, being: (i) climate change mitigation, (ii) climate change adaption, (iii) sustainable use of protection of water and marine resources, (iv) transition to a circular economy, (v) pollution prevention, and (vi) protection and restoration of biodiversity and ecosystems TCA trade and cooperation agreement between the European Union and the United Kingdom formally applicable since May 1, 2021 TEAE treatment emergent adverse events TED Thyroid eye disease TGF- transforming growth factor beta TIS total improvement score ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 Definitions | 393 Transparency Directive Directive 2004/109/EC of the European Parliament and of the Council of December 15, 2004, on the harmonization of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market and amending Directive 2001/34/EC and the rules and regulations promulgated pursuant thereto, as amended by various directives including 2013/50/EU U.S. the United States of America U.S.
Securities Act of 1933, as amended Shire Shire AG, now known as Shire International GmbH Shire Collaboration Agreement collaboration agreement entered into with Shire AG, now known as Shire International GmbH SjD Sj gren's disease SLE systemic lupus erythematosus Sopartec Sopartec S.A. System Lonza Sales AG's proprietary glutamine synthetase gene expression system known as GS Xceed Targacept Targacept Inc.
Hoffman-La Roche AG RSUs restricted stock units sBLA supplemental Biologics License Application SC subcutaneous SC subcutaneous SEC the U.S. Securities and Exchange Commission SEC Climate Rules final rules adopted by the SEC on March 6, 2024 aimed at enhancing and standardizing climate-related disclosures related to climate-related risks, Scope 1 and Scope 2 greenhouse gas emissions and climate-relateed financial metrics Securities Act the U.S.
Public Health Service Act PIL Code Belgian Code of private international law Pillar Two the project, worked on by the OECD in recent years, aimed at reforming the international tax system by, among other matters ensuring large multinational enterprises pay a minimum level of tax in each of the jurisdictions in which they operate Pillar Two Directive Directive (EU) 2022/2523 on ensuring a global minimum level of taxation for multinational enterprise groups and large-scale domestic groups in the Union PIP pediatric investigation plan PK pharmacokinetic PMDA Pharmaceuticals and Medical Devices Agency (Japan) pMN primary MN POC proof-of-concept POTELLIGENT License Agreements non-exclusive license agreements for POTELLIGENT CHOK1SV with BioWa and Lonza PREA Pediatric Research Equity Act of 2003, as amended PRR partial renal response PSU performance share unit PV pemphigus vulgaris PVAS pemphigus vulgaris activity score QA quality assurance ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 Definitions | 392 QMG quantitative myasthenia gravis RDL Reimbursable Drug List Relevant Regulatory Authorities the MHRA, EMA, FDA, MHLW REMS risk evaluation and mitigation strategy rHuPH20 recombinant human hyaluronidase PH20 Roche F.
OpEx operating expenditure PAA pre-approval access program PBM pharmacy benefit managers PC-POTS Postural Orthostatic Tachycardia Syndrome Post-COVID-19 PD pharmacodynamic PDAI pemphigus disease area index PDUFA Prescription Drug User Fee Act PF pemphigus foliaceous PFIC passive foreign investment company Pharmaceutical and Medical Devices Act the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices PHSA the U.S.
Johnson & Johnson Johson & Johnson Innovation, Inc. KPI key performance indicator LEI European legal entity identifier number LEO Pharma Pharma LEO Pharma A/S LEO Pharma Collaboration Agreement collaboration agreement entered into with LEO Pharma A/S LN lupus nephritis Lonza Lonza Sales AG LUMC Leiden University Medical Center Lundbeck H Lundbeck A/S MAA marketing authorization application mAb monoclonal antibody MADs multiple ascending doses Mainland China mainland China MAR Regulation (EU) No 596/2014 of the European Parliament and of the Council of April 2014 on market abuse (market abuse regulation) and repealing Directive 2003/6/EC European Parliament and of the Council and Commission Directives 2003/ 124/EC, 2003/EC and 2004/72/EC, and the rules and regulations promulgated pursuant thereto MBA Master's of Business Administration Medison Medison Pharma Ltd. ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 Definitions | 390 Medison Agreement exclusive distribution agreement entered into with Medison Pharma Ltd. to commercialize efgartigimod in Israel Medison Multi-Regional Agreement multi-regional agreement entered into with Medison Pharma Ltd. to commercialize efgartigimod in 14 countries MET mesenchymal-epithelial transition factor MG myasthenia gravis MG-ADL Myasthenia Gravis Activities of Daily Living MHLW Ministry of Health, Labour and Welfare MHRA Medicines and Healthcare products Regulatory Agency MMN multifocal motor neuropathy MN membranous nephropathy MRC QA Medical Regulatory and Clinical QA MSE minimal symptom expression Multi-Product License a non-exclusive multi-product in-license agreement with Lonza MuSK muscle-specific kinase Myositis idiopathic inflammatory myopathies Nasdaq the Nasdaq Global Select Market Nasdaq Listing Rules the listing rules of the Nasdaq Global Market NDA new drug application NEO named executive officer NFRD Directive 2014/95/EU of the European Parliament and 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 NHI National Health Insurance NHSA National Healthcare Security Administration NK natural killer NMJ neuro muscular junction Non-FAMP Non-Federal Average Manufacturer Price NRDL national reimbursement drug list NYU New York University NYU and LUMC Agreement collaboration and exclusive license agreements with NYU Langone Health and LUMC OCI other comprehensive income OFPs organizations for financing pensions ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 Definitions | 391 OIG the Office of Inspector General OLE open-label extension OncoVerity OncoVerity, Inc.
Handok Handok Inc. Handok Agreement an VYVGART commercial and distribution agreement entered into with Handok Hatch-Waxman Act the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 HGF hepatocyte growth factor HHS U.S. Department of Health and Human Services HIPAA the U.S. federal Health Insurance Portability and Accountability Act of 1996 HITECH the Health Information Technology for Economic and Clinical Health Act of 2009 HRSA Health Resources and Services Administration IAVI International AIDS Vaccine Initiative IDMC Independent Data Monitoring Committee IFRS International Financial Reporting Standards, as issued by the International Accounting Standards Board, and as adopted by the European Union IgA Immunoglobulin A IgD Immunoglobulin D IgG Immunoglobulin G IgM Immunoglobulin M IIP Immunology innovation program IL-22R interleukin-22 receptor IMM irreversible morbidity or mortality IMNM immune-mediated necrotizing myopathy IND investigational new drug ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 Definitions | 389 IQVIA IQVIA LTD IRA Inflation Reduction Act IRB institutional review board I-RODS Inflammatory Rasch-built Overall Disability Scale ISMS Information Security and Management System ISRs injection site reactions ISTs immunosuppressive therapies ITC Belgian Income Tax Code ITP immune thrombocytopenia IV intravenous IVIg intravenous IgG IWG International Working Group Janssen Janssen Pharmaceuticals, Inc.
Securities Exchange Act of 1934, as amended Fc antibody region interacting with cell surface Fc receptors FCP federal ceiling price FcRn neonatal Fc receptor FDA U.S. Food and Drug Administration FDCA the U.S. Federal Food, Drug, and Cosmetic Act FDORA Food and Drug Omnibus Reform Act FSS federal supply schedule FTT Financial Transaction Tax Fujifilm FUJIFILM Diosynth Biotechnologies Denmark ApS FVTOCI fair value through other comprehensive income FVTPL fair value through profit or loss GARP glycoprotein A repetitions predominant GARP Agreement a collaboration and exclusive product license agreement with UCL and its technology transfer company Sopartec GARP License exclusive, worldwide commercial in-license for use of certain GARP-related intellectual property rights owned by UCL and the Ludwig Institute for Cancer Research GCC Gulf Cooperation Council, comprising Saudi Arabia, Kuwait, the United Arab Emirates, Qatar, Bahrain and Oman GCPs good clinical practices GDPR Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016, on the protection of natural persons with regard to the processing of personal data and on the free movement of such data General Meeting any general meeting of shareholders of argenx SE (i.e., any annual general meeting and any extraordinary general meeting) Genmab Genmab A/S Genpharm Genpharm Services FZ-LLC Genpharm Agreement partnership agreement entered into with Genpharm Services FZ-ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 Definitions | 388 LLC Global Anti-Bribery and Corruption Policy our Global Anti-Bribery and Corruption Policy GloBE Rules model rules in respect of Pillar Two GLPs good laboratory practices gMG generalized myasthenia gravis Greater China Mainland China, Hong Kong, Taiwan and Macau Group argenx SE together with its subsidiaries GSK GlaxoSmithKline plc Halozyme Halozyme Therapeutics, Inc.
Elektrofi Agreement collaboration and license agreement entered into with Elektrofi EMA European Medicines Authority ENHANZE ENHANZE technology ENHANZE License Agreement in-license agreement entered into with Halozyme, Inc. Enterprise Chamber the Dutch Enterprise Chamber of the Amsterdam Court of Appeal (Ondernemingskamer van het Gerechtshof te Amsterdam) Environmental Delegated Act Delegated Regulation (EU) 2023/2486 of June 27, 2023 e-Privacy Directive Directive 2002/58/EC of the European Parliament and of the Council of July 12, 2002 Equity Incentive Plan the equity incentive plan as adopted by our Board of Directors on December 18, 2014, which was approved by the General Meeting on May 13, 2015, and amended by the General Meeting on April 28, 2016, and November 25, 2019, and the Board of Directors on December 18, 2019, November 5, 2020, December 15, 2021 and on February 27, 2023 ESG environmental, social and corporate governance ETASU elements to assure safe use EU European Union EU-IFRS International Financial Reporting Standards and the interpretations issued by the IASB's International Financial Reporting Interpretation Committee as adopted by the European Union Euronext Brussels the regulated market operated by Euronext Brussels SA/NV, a regulated market within the meaning of Directive 2014/65/EU of the European Parliament and of the Council of May 15, 2014, on markets in financial instruments amending Council Directives 2004/39/EC, Directive 85/611/EEC, 93/6/EEC and Directive 2000/ ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 Definitions | 387 12/EC of the European Parliament and of the Council and repealing Council Directive 93/22/EEC (MiFID II) EU Taxonomy Legal Framework the EU Taxonomy Regulation, the Climate Delegated Act, the Environmental Delegated Act, the Article 8 CDR and ancillary legislation currently applicable to us EU Taxonomy Regulation 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 Exchange Act the U.S.
DFSA Dutch Financial Supervision Act (Wet op het financieel toezicht) DGF delayed graft function DHS dehydrated hereditary stomatocytosis ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 Definitions | 386 Dividend Received Deduction deduction of 100% of the gross dividend received from taxable income DM dermatomyositis DPO data protection officer Draft 2024 Remuneration Policy the Company's draft 2024 remuneration policy, which expected to be published in draft form on or around March 21, 2024 DSA donor specific antibodies ECDRP European Commission Decision Reliance Procedure ECL expected credit loss EEA European Economic Area Elektrofi Elektrofi, Inc.
CIDP chronic inflammatory demyelinating polyneuropathy Climate Delegated Act Commission Delegated Regulation (EU) 2021/2139 of June, 4 2021 supplementing Regulation (EU) 2020/852 of the European Parliament and of the Council by establishing the technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to climate change mitigation or climate change adaptation and for determining whether that economic activity causes no significant harm to any of the other environmental objectives CMOs contract manufacturing organizations CMS Congenital myasthenic syndrome or Centers for Medicare & Medicaid, as the context dictates Code of Conduct our Code of Business Conduct and Ethics COMP European Medicines Authority's Committee for Orphan Medicinal Products Concerned Member States the competent authorities of all European Union Member States in which an application for authorization of a clinical trial has been submitted COO chief operating officer CPRA California Privacy Rights Act of 2020 CRmin minimal dose of steroids CRO contract research organization CRR complete renal response CSRD 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 CTA clinical trial application CTR EU Regulation No 536/2014 of the European Parliament and of the Council of April, 16 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (clinical trials regulation) DCC Dutch Civil Code (Burgerlijk Wetboek) DCGC the Dutch Corporate Governance Code 2022 Deloitte Deloitte Accountants B.V.
BP bullous pemphigoid BPCIA the U.S. Biologics Price Competition and Innovation Act Broteio Broteio Pharma B.V. Broteio Agreement collaboration agreement entered into with Broteio C2 component 2 CapEx capital expenditure CBA collective bargaining agreement CCPA California Consumer Privacy Act of 2018 CEO chief executive officer CFO chief financial officer cGMPs current good manufacturing practices CHMP Committee for Medicinal Products for Human Use ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 Definitions | 385 Chugai Chugai Pharmaceutical Co., Ltd.
ALS amyotrophic lateral sclerosis Amgen Amgen, Inc. AML acute myeloid leukemia AMP average manufacturer price AMR antibody-mediated rejection Annual Report this annual report argenx Activities the argenx activities identified as core activities for the purposes 8.3 ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 Definitions | 384 of the EU Taxonomy Legal Framework, such activities being research and development and marketing of pharmaceutical products and wholesale thereof argenx or the Company argenx SE Article 8 CDR Commission Delegated Regulation (EU) 2021/2178 of July 6, 2021 supplementing Regulation (EU) 2020/852 of the European Parliament and of the Council by specifying the content and presentation of information to be disclosed by undertakings subject to Articles 19a or 29a of Directive 2013/34/EU concerning environmentally sustainable economic activities, and specifying the methodology to comply with that disclosure obligation Articles of Association our current articles of association Asset Development Agreement the asset development agreement entered into with IQVIA ASyS anti-synthetase syndrome AV anti-neutrophil cytoplasmic antibody-associated Vasculitis B-cell B-lymphocyte BioWa BioWa, Inc BioWa Agreement non-exclusive license agreement entered into with BioWa BLA biologics license application Board By-Laws the rules adopted by our Board of Directors that describe the procedure for holding meetings of the Board of Directors, for the decision-making by the Board of Directors and the Board of Directors' operating procedures Board of Directors consisting of our executive director(s) and our non-executive directors.
AbbVie Collaboration Agreement the collaboration agreement with AbbVie, Inc. to develop and commercialize ARGX-115 (ABBV-151) as a cancer immunotherapy against the novel target GARP ACA the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 Accounting Directive Directive 2013/34/EU AChR anti-acetylcholine receptor AChR-AB+ AChR antibody positive ADCC antibody-dependent cell-mediated cytotoxicity ADSs American depositary share AFM the Dutch Authority for the Financial Markets (Stichting Autoriteit Financi le Markten) Agomab Agomab Therapeutics NV AKS the U.S. federal Anti-Kickback Statute Alexion Alexion Pharmaceuticals, Inc.
The definitions set out below apply throughout this Annual Report, unless the context requires otherwise. Term Definition 2021 Remuneration Policy 2021 remuneration policy 2023 20-F Form 20-F for the year ended December 31, 2023 2023 General Meeting annual General Meeting was held on May 2, 2023 2024 General Meeting the Company's annual General Meeting that will take place on May 7, 2024 AAV ANCA-associated vasculitis AbbVie AbbVie, Inc.
Signed on behalf of argenx SE 8.2 ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 Management Confirmations | 383 Definitions The following explanations are intended to assist the general reader to understand certain terms used in this Annual Report.
This Annual Report, particularly section 2 Risk Factors states the material risks, as referred to in best practice provision 1.2.1 and the uncertainties, to the extent that they are relevant to the expectation of our continuity for the period of 12 months after the preparation of this Annual Report. The aforementioned statement does not in any way limit the relevance or applicability of the Risk Factors set out in this Annual Report to the aforementioned period of 12 months.
We confirm that we expect that our existing cash and cash equivalents and current financial assets will enable us to fund our operating expenses and capital expenditure requirements through at least the next 12 months. On the basis of the current state of affairs, it is justified that the financial reporting is prepared on a going concern basis; and iv.
This Annual Report provides sufficient insights into any failings in the effectiveness of the internal risk management and control systems, with regard to the risks as referred to in best practice provision 1.2.1 of the DCGC, as is further substantiated in section 2 Risk Factors, and section 3 Corporate Governance . ii. The risk- and control systems described herein, particularly in paragraph 3.9.5 Financial Risks and Controls provide reasonable assurance that the financial reporting does not contain any material inaccuracies; iii.
Operating and Financial Review Article 2:392 DCC/RJ 410 Auditor's opinion Attached to the 2023 Annual Report included herein Articles of association on the distribution of profits Articles of Association on Profits, distributions and losses List of subsidiaries Company Profile Group Structure Decree on contents of board report (Besluit inhoud bestuursverslag), Article 2:391 sub 5 DCC Corporate governance code comply-or-explain Dutch Corporate Governance Code, Comply or Explain Main elements of financial management & control systems in connection with the company's financial reporting Financial Risks and Controls Functioning of the general meeting General Meeting and Voting Rights Composition and functioning of the board of directors and its committees Board of Directors Non-Executive Directors Article 10 Decree Takeover Directive (Besluit artikel 10 overnamerichtlijn), Capital structure General description of the Company and its Share Capital 8.1 ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 Cross Reference table for annual reporting requirement | 382 Source of Requirement Topic Location Article 2:391 sub 5 DCC Principal shareholders Share Classes and Principal Shareholders Particular shareholder rights and limitations thereof General Meetings and Voting Rights Procedure for appointment of board members Management Structure Procedure for amending the articles of association Amendment of Articles of Association Authority of the board of directors to issue or acquire shares Issue of Shares Acquisition of Shares in our Capital Material arrangements, to which the company is a party, in relation to a public offer Anti-Takeover Provisions RJ = Guidelines on Annual Reporting (Richtlijnen voor de Jaarverslaggeving) Management Confirmations With due regard to best practice provision 1.4.3 of the DCGC, we confirm that: i.
Source of Requirement Topic Location Article 2:391 DCC, RJ 400, RJ 405 Report on the Company's activities Shareholder Letter Presentation of the Group Corporate structure General Description of the Company and its Share Capital Board of Directors report Corporate Governance Primary risks and uncertainties Risk Factors Risk appetite & control Risk Appetite & Control Analysis of financial condition and results Operating and Financial Review Information on research and development activities Our Products and Product Candidates Collaborations and Licenses Forward looking paragraph 2024 Outlook Compensation statements and remuneration report Remuneration Report and Compensation Statement RJ 430 Key figures, ratios etc.
TAXONOMY-NON-ELIGIBLE ACTIVITIES EUR % OpEx of Taxonomy-non-eligible activities (B) 479,934 100 Total (A + B) 479,934 100 ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 EU Taxonomy | 380 Glossary 8.1 Cross Reference table for annual reporting requirement 382 8.2 Management Confirmations 383 8.3 Definitions 384 8 argenx Annual Report 2023 Glossary | 381 8 Glossary Cross Reference table for annual reporting requirement The following list of cross references identifies where each item required for us to disclose in our yearly financial report can be found in this Annual Report.
TAXONOMY-ELIGIBLE ACTIVITIES A.1 Environmentally sustainable activities (Taxonomy-aligned) EUR % Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL % Y; N; N/EL Y; N; N/EL 0 N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0 N/EL N/EL 0 N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0 N/EL N/EL 0 N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0 N/EL N/EL OpEx of environmentally sustainable activities (Taxonomy-aligned) (A.1) 0.00 0 N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0 Of which Enabling N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0 N/EL Of which Transitional N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0 N/EL ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 EU Taxonomy | 379 2023 Substantial contribution criteria DNSH criteria (Do no significant harm) A.2 Taxonomy-eligible but not environmentally sustainable activities (Taxonomy-non-aligned activities) EUR % EL; N/EL EL; N/EL EL; N/EL EL; N/EL EL; N/EL EL; N/EL % 0 EL N/EL N/EL N/EL N/EL N/EL 0 0 EL N/EL N/EL N/EL N/EL N/EL 0 0 EL N/EL N/EL N/EL N/EL N/EL 0 OpEx of Taxonomy-eligible but not environmentally sustainable activities (not Taxonomy-aligned activities) (A.2) 0 0 0 Total (A.1 + A.2) 0 0 B.
Research and development only undertakings related to OpEx are listed in the consolidated financial statements, included in footnote 19, Research & development expense. Proportion of OpEx from products or services associated with Taxonomy-aligned economic activities disclosure covering 2023 2023 Substantial contribution criteria DNSH criteria (Do no significant harm) Economic activities Code(s) OpEx Propor-tion of OpEx Climate change miti-gation Climate change adap-tation Water Pollu-tion Circular eco-nomy Biodi-versity Climate change miti-gation Climate change adap-tation Water Pollu-tion Circular eco-nomy Biodi-versity Mini-mum safe-guards Propor-tion of taxo-nomy-aligned (A.1.) or eligible (A.2.) OpEx, year 2022 Cate-gory (ena-bling activity) Cate-gory (transi-tional activity) A.
Our denominator for calculation of OpEx KPIs, covering non-capitalized costs such as research and development, building renovation, short-term lease, maintenance and repair, and day to day service of plant, property and equipment during the financial year (as listed in Annex I, point 1.1.3.1 of Article 8 CDR), totals $859.5 million across research and development only, as the remaining topics defined are not currently part of operational expenditure.
TAXONOMY-NON-ELIGIBLE ACTIVITIES EUR % CapEx of Taxonomy-non-eligible activities (B) 147,903 100 Total (A + B) 147,903 100 ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 EU Taxonomy | 378 OpEx Eligibility and Alignment We have concluded that as eligibility for the argenx Activities is nil, alignment related to OpEx is also considered to be nil and totals 0%.
TAXONOMY-ELIGIBLE ACTIVITIES A.1 Environmentally sustainable activities (Taxonomy-aligned) EUR % Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL % Y; N; N/EL Y; N; N/EL 0 N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0 N/EL N/EL 0 N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0 N/EL N/EL 0 N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0 N/EL N/EL CapEx of environmentally sustainable activities (Taxonomy-aligned) (A.1) 0 N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0 Of which Enabling N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0 N/EL Of which Transitional N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0 N/EL ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 EU Taxonomy | 377 2023 Substantial contribution criteria DNSH criteria (Do no significant harm) A.2 Taxonomy-eligible but not environmentally sustainable activities (Taxonomy-non-aligned activities) EUR % EL; N/EL EL; N/EL EL; N/EL EL; N/EL EL; N/EL EL; N/EL % 0 EL N/EL N/EL N/EL N/EL N/EL 0 0 EL N/EL N/EL N/EL N/EL N/EL 0 0 EL N/EL N/EL N/EL N/EL N/EL 0 CapEx of Taxonomy-eligible but not environmentally sustainable activities (not Taxonomy-aligned activities) (A.2) 7,135 18 0 Total (A.1 + A.2) 7,204 18 0 B.
Proportion of CapEx from products or services associated with Taxonomy-aligned economic activities disclosure covering 2023 2023 Substantial contribution criteria DNSH criteria (Do no significant harm) Economic activities Code(s) CapEx Propor-tion of CapEx Climate change miti-gation Climate change adap-tation Water Pollu-tion Circular eco-nomy Biodi-versity Climate change miti-gation Climate change adap-tation Water Pollu-tion Circular eco-nomy Biodi-versity Mini-mum safe-guards Propor-tion of taxo-nomy-aligned (A.1.) or eligible (A.2.) CapEx, year 2022 Cate-gory (ena-bling activity) Cate-gory (transi-tional activity) A.
Our denominator for calculation of CapEx KPIs, covering tangibles and intangible assets during the financial year (as listed in Annex I, point 1.1.2.1 of Article 8 CDR) totals $68 million. Non-financial undertakings related to CapEx are listed in the consolidated financial statements, included as additions in footnote 4, Property, plant and equipment and footnote 5, Intangible assets.
TAXONOMY-NON-ELIGIBLE ACTIVITIES EUR % Turnover of Taxonomy-non-eligible activities (B) 1,226,316 100 Total (A + B) 1,226,316 100 ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 EU Taxonomy | 376 CapEx Eligibility and Alignment We have concluded that as eligibility for the argenx Activities is nil, alignment related to CapEx is also considered to be nil and totals 0%.
TAXONOMY-ELIGIBLE ACTIVITIES A.1 Environmentally sustainable activities (Taxonomy-aligned) EUR % Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL Y; N; N/EL % Y; N; N/EL Y; N; N/EL 0 N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0 N/EL N/EL 0 N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0 N/EL N/EL 0 N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0 N/EL N/EL Turnover of environmentally sustainable activities (Taxonomy-aligned) (A.1) 0 N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0 Of which Enabling N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0 N/EL Of which Transitional N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0 N/EL ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 EU Taxonomy | 375 2023 Substantial contribution criteria DNSH criteria (Do no significant harm) A.2 Taxonomy-eligible but not environmentally sustainable activities (Taxonomy-non-aligned activities) EUR % EL; N/EL EL; N/EL EL; N/EL EL; N/EL EL; N/EL EL; N/EL % 0 EL N/EL N/EL N/EL N/EL N/EL 0 0 EL N/EL N/EL N/EL N/EL N/EL 0 0 EL N/EL N/EL N/EL N/EL N/EL 0 Turnover of Taxonomy-eligible but not environmentally sustainable activities (not Taxonomy-aligned activities) (A.2) 7,135 18 0 Total (A.1 + A.2) 7,204 18 0 B.
We have concluded that as eligibility for the argenx Activities is nil, alignment related to turnover is also considered to be nil and totals 0%. Our net turnover KPI denominator, covering product net sales and collaboration revenue (as listed in Annex I, point 1.1.1 of Article 8 CDR), totals $1.2 billion. Non-financial undertakings related to turnover are included in the consolidated financial statements, under footnote 15, Product net sales and footnote 16, Collaboration revenue. ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 EU Taxonomy | 374 Proportion of turnover from products or services associated with Taxonomy-aligned economic activities disclosure covering 2023 2023 Substantial contribution criteria DNSH criteria (Do no significant harm) Economic activities Code(s) Turnover Proportion of Turnover Climate change miti-gation Climate change adap-tation Water Pollu-tion Circular eco-nomy Biodi-versity Climate change miti-gation Climate change adap-tation Water Pollu-tion Circular eco-nomy Biodi-versity Mini-mum safe-guards Propor-tion of taxo-nomy-aligned (A.1.) or eligible (A.2.) Turnover, year 2022 Cate-gory (ena-bling activity) Cate-gory (transi-tional activity) A.
Future EU Taxonomy disclosures We are committed to the continued and ongoing assessment of our taxonomy eligibility on an annual basis and note that the required disclosures under the EU Taxonomy Legal Framework will keep evolving. Turnover Eligibility and Alignment Since the argenx Activities are EU Taxonomy non-eligible activities, they are not included in our turnover key performance indicators (KPI).
All of the activities mentioned in this paragraph will hereinafter be referred to as the argenx Activities. Following a thorough analysis of the EU Taxonomy Legal Framework, we do not consider the argenx Activities to be in scope of the Climate Delegated Act or the Environmental Delegated Act. We have concluded that the argenx Activities qualify as EU Taxonomy non-eligible 7.3.2 ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 EU Taxonomy | 373 economic activities and that they do not substantially contribute to any of the Taxonomy Environmental Objectives.
In this context, we, as a commercial-stage biopharmaceutical group, define the research and development and marketing of pharmaceutical products and wholesale thereof as the core of our business activities. We define activities such as the manufacturing or the transport of our pharmaceutical products to our clients as underlying activities necessary to conduct our core business activities.
According to the Dutch national transposition of the NACE code, the more specific level of the NACE code for our main activity is NACE 72.11 Research and experimental development on biotechnology; and - NACE 46.46 Wholesale of pharmaceutical and medical goods. Our assessment of taxonomy-eligibility is focused on economic activities, defined as the provision of goods or services on a market, thus (potentially) generating revenues.
The sectors covered include energy, selected manufacturing activities, transport and buildings. Our assessment methodology for 2023 is listed below and is based on the EU Taxonomy Legal Framework applicable as of January 1, 2024. Companies are required to identify if their activities are eligible under the EU Taxonomy Regulation. On the basis of Commission Delegated Regulation (EU) 2023/137 amending Regulation (EC) No 1893/2006 of the European Parliament and of the Council establishing the statistical classification of economic activities NACE Revision 2, our main activities are: - NACE 72.10 Research and experimental development on natural sciences and engineering.
Compliance with the EU Taxonomy Regulation In 2023 we performed a reassessment of all potential taxonomy-eligible economic activities, including all Taxonomy Environmental Objectives, listed in the Climate Delegated Act and the Environmental Delegated Act, based on our activities as a biopharmaceutical group for the current year's activity. The Climate Delegated Act focuses on those economic activities and sectors that have the greatest potential to achieve the Taxonomy Environmental Objectives.
These delegated acts were published in the Official Journal on November, 21 2023 and apply as of January 1, 2024 for annual reporting periods occurring in 2023. As such, these requirements have been taken into account in this annual report. In this section we present our compliance with the EU Taxonomy Regulation, the Climate Delegated Act, the Environmental Delegated Act, the Article 8 CDR and ancillary legislation currently applicable to us (the EU Taxonomy Legal Framework).
This includes Delegated Regulation (EU) 2023/2486 of June 27, 2023 (the Environmental Delegated Act). These delegated acts updates to the mandatory reporting templates, set out technical screening criteria for additional activities for the first two environmental objectives; climate change adaptation and climate change mitigation. These delegated acts also introduce technical screening criteria and relating reporting obligations for activities pursuing the remaining four environmental objectives; (i) sustainable use and protection of water and marine resources, (ii) transition to a circular economy, (iii) pollution prevention and control, and (iv) protection and restoration of biodiversity and ecosystems (together with the first two environmental objectives, hereinafter referred to as the Taxonomy Environmental Objectives).
On March 9, 2022, the EU Commission adopted a complementary climate delegated act including, under strict conditions, specific nuclear and gas energy activities in the list of economic activities covered by the EU taxonomy. It was published in the Official Journal on July 15, 2022 and became effective in January 2023. 7.3 7.3.1 ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 EU Taxonomy | 372 On June, 27 2023, the Commission adopted final delegated acts, supporting the EU Taxonomy Regulation.
The EU Commission further adopted the Commission Delegated Regulation (EU) 2021/2178 of July 6, 2021 supplementing Regulation (EU) 2020/852 of the European Parliament and of the Council by specifying the content and presentation of information to be disclosed by undertakings subject to Articles 19a or 29a of Directive 2013/34/EU concerning environmentally sustainable economic activities, and specifying the methodology to comply with that disclosure obligation (the Article 8 CDR), which also became effective in January 2022.
The EU Commission has adopted a catalogue of economic activities that can be taken into account for these objectives. On April 21, 2021, the EU Commission adopted the Commission Delegated Regulation (EU) 2021/2139 of June 4, 2021 supplementing Regulation (EU) 2020/852 of the European Parliament and of the Council by establishing the technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to climate change mitigation or climate change adaptation and for determining whether that economic activity causes no significant harm to any of the other environmental objectives (the Climate Delegated Act), which became effective in January 2022.
The EU taxonomy framework will develop over time. Article 9 of the EU Taxonomy Regulation identifies six environmental objectives: (1) climate change mitigation; (2) climate change adaptation; (3) the sustainable use and protection of water and marine resources; (4) the transition to a circular economy (5) pollution prevention and control; and (6) the protection and restoration of biodiversity and ecosystems.
Each of these positions is characterized by a high impact across the organization, leading a global and cross functional team and having a global reach. We estimate that as of December 31, 2023, 58% of our workforce were female and 42% were male (compared to 63% female and 37% male as of December 31, 2022). EU Taxonomy Introduction to the EU Taxonomy Regulation The EU Taxonomy Regulation entered into force on July 12, 2020 and establishes the general framework for determining whether an economic activity qualifies as environmentally sustainable for the purposes of establishing the degree to which an investment is environmentally sustainable.
As 7.2.7 ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 NFRD | 371 at December 31, 2023 and December 31, 2022, our Company leadership team consisted of 31 persons, comprised of a mix of 19 males and 12 females, (61%/39% respectively). Our leadership consists of all full time employees reporting directly to our CEO, as well as all (other) leaders of our largest functions and projects.
Of the directors who chose to disclose their gender, the Board of Directors contained five male directors and three female directors (non-executive directors), translating into a 55.55% male/331/3% female balance for our full Board of Directors (compared to five males and three females (non-executive directors) (55.55%/331/3%) as of December 31, 2022) and a 62.5% male/37.5% female balance for our non-executive directors (compared to 62.5% male/37.5% female as of December 31, 2022).
We aim to have an equal gender balance in our Board of Directors and in our Company leadership (including functional leaders and project leaders). The outcome of those policies, results of the Diversity, Equity and Inclusion Policy As at December 31, 2023, our Board of Directors consisted of nine directors, including one executive director and eight non-executive directors.
We will continue to implement our diversity, equity and inclusion policy by seeking new ways to improve and support diversity, equity and inclusion in our company. Diversity targets We aim to foster an inclusive work environment in support of our strategic plan and priorities. We continue to raise the bar in this regard, and to commit to measures and goals designed to support our maturing company culture.
Our onboarding program is designed to promote inclusion by building a strong social fabric across teams, functions and geographic locations. Furthermore, all employees are encouraged to participate in a personal development program aimed at building on their individuals strengths to benefit the broader team. We offer opportunities for promotion, training and career development solely based on job-related, appropriate criteria such as skills, competencies, experience, aptitude and enthusiasm and giving account to each individual's experience, ambitions and capabilities.
We value our fair, inclusive recruitment process, which is standardized across the organization and focuses on pre-identified what counts' factors. The process involves a diverse group of colleagues from across the organization, who are provided with training to recognize any existing biases. Recruitment decisions are based on a group evaluation of available candidates, ensuring different perspectives.
Everyone has a voice and is encouraged to contribute to the benefit of our common goals, irrespective of race, ethnicity, age, gender or cultural background. Good ideas as well as real concerns are taken seriously, regardless of who brings them forward. How our diversity, equity and inclusion policy is being implemented. Our diversity, equity and inclusion policy is implemented in the way we recruit, develop and promote our employees and Board of Directors.
Fostering an inclusive work environment where everyone feels safe and encouraged to contribute leads to better work outcomes and supports high levels of employee commitment and retention. We aspire to be a consciously global company. Our success is built on, and dependent on true collaboration in cross-functional and often cross-regional teams in which open communication is encouraged and safeguarded.
Acknowledging and benefiting from different perspectives promotes diversity of thought and empowers innovation. It also contributes to our commitment to improve lives of patients, wherefore we need teams with a healthy mix of contrasting perspectives and backgrounds that reflect the diverse communities we serve. We recognize that our people are our greatest strength.
We believe that a diverse workforce enhances our overall performance and success. We take pride in creating and sustaining a culture and environment where each of us can excel. We bring together people with diverse backgrounds experiences and functional expertise. By doing so, we broaden the scope of ideas and creativity essential to developing and delivering innovative therapies to patients.
Employees can raise any concerns they may have regarding potential violations of our policy confidentially or anonymously (to the extent allowed by law), including in relation to violations of our Code of Conduct on human rights related topics. Non-financial key performance indicators In fiscal year 2023, we did not identify any breaches of our Code of Conduct or our Global Anti-Bribery and Corruption Policy in relation to anti-corruption or anti-bribery matters. ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 NFRD | 370 Insight into our diversity, equity and inclusion policy and practices Policies pursued, including due diligence processes We value diversity among our colleagues as an integral component in building a sustainable growth platform.
We established the argenx COMPASS Helpline in order to maintain oversight over compliance with our Code of Conduct and other of our company policies including in relation to potential violations in the area of anti-bribery and anti-corruption, and to increase compliance and ensure our colleagues know where to go with questions on the Code of Conduct and its application.
We have recruited a dedicated legal and compliance team to support and monitor compliance with relevant rules and regulations. Furthermore, all employees are trained annually on our Code of Conduct, including its provisions on anti-bribery and anti-corruption. Accepting, and committing to, the contents thereof is expected of all newcomers to argenx.
How these risks are managed To avoid even the suggestion of a conflict of interest, we conduct all interactions with healthcare professionals with the utmost integrity, scrupulously adhering to government and industry body regulations, as well as enforcing our own strict internal guidelines. We have designed and implemented a targeted compliance program consisting of a body of codes, policies and procedures, which we actively and regularly train all relevant personnel on.
Because many of our healthcare professional are also our customers, there is the risk that patients and others might perceive potential conflicts of interest, even when none exist. Failure to comply with applicable healthcare laws and regulations may lead to enforcement including civil and administrative penalties, fines or criminal prosecution and may cause us to incur significant costs and harm to our business and reputation.
Outcome of those policies In fiscal year 2023, we did not identify any breaches of our Code of Conduct or our Global Anti-Bribery and Corruption Policy in relation to anti-corruption or anti-bribery matters. Principal risks We may be subject to healthcare laws, regulation and enforcement. Our failure to comply with these laws could harm our results of operations and financial conditions.
All arrangements (or reimbursement of expenses) for travel, lodging, and meals that are provided to healthcare professionals or government officials relating to their performance of services must be consistent with Company policies. We ensure that that we avoid even the perception of improper influence by refraining from offering gifts or other items of value.
Business relationships must not be created as a disguised means to induce or reward healthcare professionals or government officials to prescribe, purchase, or recommend argenx products. 7.2.6 ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 NFRD | 369 - The selection of healthcare professionals or government officials must be based on their qualifications, expertise, capabilities, experience and other appropriate criteria directly related to the identified need. - A written contract must be executed prior to the commencement of the services that accurately describes the nature of the services and the basis for remuneration. - All compensation to healthcare professionals or government officials must reflect fair market value for the services provided. - Meetings or events organized or sponsored by argenx involving healthcare professionals or government officials services must be held at appropriate venues that are conducive to the purpose of the meeting or event.
We exercise care when entering into arrangements with business third parties, including distributors, suppliers or others who are operating on our behalf. As a general rule, we are committed to never doing anything through a business intermediary that we are not permitted to do ourselves. In addition, whenever we hire a healthcare professional or a government official as a consultant, advisor, investigator, speaker, or in any other capacity, we require the following requirements to be met: - There must be a documented legitimate business need for the services on the part of argenx.
Bribery Act that are international in scope. - Avoiding inappropriate influence. We are committed to conducting business that is free from the influence of corruption. No employee, or anyone working on our behalf, should ever directly or through an intermediary offer or give anything of value to anyone to obtain an improper business advantage, nor should anyone representing argenx accept anything of value from a third party in return for preferential treatment. - Third parties.
We are committed to adhering to all international and local laws and regulations that cover bribery and corruption everywhere we operate. Accordingly, our employees and those acting on our behalf are responsible for knowing and complying with the laws and regulations that apply to their job roles and the countries in which they do business. This is particularly important in the area of bribery and corruption, where a number of countries have implemented laws, such as the Foreign Corrupt Practices Act and the U.K.
We never offer, promise, or provide anything of value to improperly influence a business decision or for the purpose of obtaining or retaining business. Our Code of Conduct and our Global Anti-Bribery and Corruption Policy, which applies to our employees as well as consultants (including ad hoc contractors) working on behalf of argenx, sets forth the following minimum standards that apply to every interaction in every market in which we operate even if these standards are higher than those practiced by others and even if this may mean giving up certain business opportunities: - Compliance with local and international laws and regulations.
Non-financial key performance indicators In fiscal year 2023, there were no alleged breaches of our Code of Conduct on the topics of human rights or alleged forced labor or child labor. Matters with respect to anti-corruption and bribery Policies pursued, including due diligence processes We do not tolerate bribery or corrupt conduct, either in our direct business dealings or by a third party acting on our behalf.
Outcome of those policies In fiscal year 2023, there were no alleged breaches of our Code of Conduct on the topics of human rights or alleged forced labor or child labor. Principal risks We have assessed our activities to date and did not identify specific risks of violations of human rights in relation to our business activities and as such we have not identified the risk of violations of human rights as principal risk for argenx. 7.2.5 ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 NFRD | 368 How these risks are managed In order to maintain oversight over compliance with the our Code of Conduct and other company policies including in relation to potential violations in the area of human rights, and to increase compliance and ensure our colleagues know where to go with questions on the Code of Conduct and its application, we have established the argenx COMPASS Helpline, where our employees can raise any concerns they may have regarding potential violations of our policy confidentially or anonymously (to the extent allowed by law), including in relation to violations of our Code of Conduct on human rights related topics.
Our Code of Conduct includes our commitment to respecting the human rights of all people and ensure fairness in the workspace. All our personnel is trained annually on our Code of Conduct including its provisions on respecting human rights. Accepting, and committing to, the contents of the aforementioned Code of Conduct is expected of all newcomers to argenx.
When selecting our business associates, we strive to work with third parties who share our commitment to respecting and improving human rights, and we do not conduct business with any individual or company that participates in forced, bonded or indentured labor or involuntary prison labor, the exploitation of children (including child labor), harsh or inhumane treatment or threat of any such treatment or any form of modern slavery or human trafficking.
Matters with respect to human rights Policies pursued, including due diligence processes We commit to compliance with international labor standards as well as applicable labor and employment laws, wherever we operate. This includes prohibiting child labor and forced labor, upholding the right to freedom of association, and eliminating discrimination at work.
Employees can raise any concerns they may have regarding potential violations of our Code of Conduct confidentially or anonymously (to the extent allowed by law) through our COMPASS Helpline, including in relation to violations of our Code of Conduct on environmental matters or in relation to violations of our Animal Welfare Policy. Non-financial key performance indicators At the date of this Annual Report, for the fiscal year ended December 31, 2023, we have not identified any material breaches of our Code of Conduct in relation to environmental matters, and we have not identified any material breaches of our Animal Welfare Policy.
We train all personnel involved in research activities with live animals, on our Animal Welfare Policy. The COMPASS Helpline enables us to maintain oversight over compliance with our Code of Conduct and other Company policies including in relation to potential violations in the area of environmental matters, and to increase compliance and ensure our colleagues know where to go with questions on the Code of Conduct and its application.
How these risks are managed We comply with environmental laws and regulations that are related to our specific work and responsibilities and offer training to our employees depending on their area of work. In addition, we have a dedicated safety advisor and facility manager supervising compliance with environmental law on our premises. All employees receive health and safety training relevant to their specific job role.
For these activities we require, and have obtained, the necessary environmental and biohazard permits from the responsible governments, required by us for the manner in which we use said facilities. We may become exposed to liability and substantial expenses in connection with environmental compliance or remediation activities. Our personnel could breach the animal welfare commitments set out in our Code of Conduct or our Animal Welfare Policy.
Principal risks We have assessed our activities to date and did not identify specific risks of material environmental violations and as such we have not identified environmental risks as principal risks for argenx. Our primary research and development activities take place in our facilities in 7.2.4 ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 NFRD | 367 Zwijnaarde, Belgium.
Outcome of those policies All employees have accepted and are trained (and retrained annually) on our Code of Conduct, and accepting, and committing to, the contents thereof is expected of all newcomers to argenx. At the date of this Annual Report, for the fiscal year ended December 31, 2023, we have not identified any material breaches of our Code of Conduct in relation to environmental matters.
We conduct our activities within the environmental regulatory framework set out by those jurisdictions in which we operate in and have obtained all required environmental licenses and permits. With the goal of mitigating the risk of failure to obtain any required environmental permits or licenses, or of losing granted permits or licenses we may need to operate our business, we regularly evaluate the requirements of such environmental permits and licenses to ensure continued compliance.
Compliance, audits and certification of all third parties is overseen by a management-level animal welfare committee, who are responsible for organizing regular lab visits in the EU. Where we are unable to perform in-person audits at our U.S.-based academic collaborators, or elsewhere, our audits are performed virtually. We do not currently have an environmental policy.
Our Animal Welfare Policy requires us to perform due diligence on third party collaborators who engage in research activities on our behalf, by reviewing their external certification on this topic (such as Association for Assessment and Accreditation of Laboratory Animal Care International certification) or if they have not (yet) been certified, by performing our own confirmatory due diligence through reviews and/or interviews or written questions and answers to gain comfort that the standards applied are at the same level as our internal standards on this topic.
We cannot replace all animal experiments in the foreseeable future, but we continuously review the welfare and use of animals and develop procedures that reduce or replace animal experiments. If we engage in research using live animals, we follow all applicable laws and regulations, and argenx policies. We commit to treating research animals in a humane and responsible manner, in accordance with Code of Conduct and our Animal Welfare Policy.
We are committed to expanding and developing our sustainability initiatives in the future. Given the present state of scientific knowledge, it is not possible to examine the complex interactions in a living organism solely by the use of modeling or performing experiments in cell cultures and tissue samples. Research using living animals remains essential in the discovery, development and production of new medicines.
In an effort to do this we: - comply with environmental laws and regulations that are related to our specific work and responsibilities. - encourage colleagues to respect the environment and natural resources available to us by taking sustainability steps like limiting energy use, reducing waste, and recycling. - have awareness and training programs to teach our employees how to deal with different waste systems.
Our voluntary employee turnover rate for fiscal year 2023 was 5% and our involuntary employee turnover rate for fiscal year 2023 was 2%, both numbers we believe to be below industry averages. ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 NFRD | 366 Environmental matters Policies pursued, including due diligence processes argenx is dedicated to conducting its 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 colleagues, business partners, and surrounding communities as well.
We pay close attention to creating an environment that supports the further development of the talents of our key people, including through our personal development plan program. Non-financial key performance indicators At the date of this Annual Report, for the fiscal year ended December 31, 2023, we have not identified any material breaches of our Code of Conduct in relation to social or employee matters.
We offer competitive remuneration packages and share-based incentives in the form of an Equity Incentive Plan in which all employees are offered the opportunity to participate. We perform periodic benchmark analyses with an external service provider to ensure the competitiveness of the compensation offered to our key personnel in comparison to other (reference group) companies.
We have set-up a specific helpline reachable through different channels including by phone, also anonymously, to report any suspected potential violations. Also, to mitigate the risks of non-compliance with our Code of Conduct in relation to employee and social matters, we require all new employees to confirm their acceptance and adherence to the Code of Conduct and we train existing and new employees annually on our Code of Conduct and our Speak-up Policy.
We revised our Whistleblower Policy into our new Speak-up Policy to comply with Directive (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of EU law, which policies (jointly our Speak Up and Anti-retaliation Policy) enables and encourages our employees to speak up and report any suspected violation of our Code of Conduct, and to protect employees from retaliation.
How these risks are managed In order to maintain oversight over compliance with the our Code of Conduct and other company policies including in relation to potential violations in the area of employee and social matters, and to increase compliance and ensure our colleagues know where to go with questions on the Code of Conduct and its application, we have established the argenx COMPASS Helpline, where our employees can raise any concerns they may have regarding potential violations of our policy confidentially or anonymously (to the extent allowed by law).
Principal risks Our employees and relevant third parties may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could have a material adverse effect on our business. Our future growth and ability to compete depends in part on our ability to retain key personnel and recruit additional qualified personnel.
Outcome of those policies All employees have accepted and are trained (and retrained annually) on our Code of Conduct, and accepting, and committing to, the contents thereof is expected of all newcomers to argenx. At the date of this Annual Report, for the fiscal year ended December 31, 2023, we have not identified any material breaches of our Code of Conduct in relation to social or employee matters.
Once informed, we will take all measures required to stop any such behavior and to deal appropriately with the person or persons involved. The matter will be treated with discretion and diligence. We strictly prohibit retaliation or retribution against anyone who in good faith reports a concern about harassment, discrimination, or other issues, or cooperates with an 7.2.3 ar Gr g oup enx Factors Risk Go Corporate vernance Capital Share Financial Review Statements Financial Non-Financial Information argenx Annual Report 2023 NFRD | 365 investigation into alleged harassment and discrimination, even if the initial concern is ultimately determined to be unfounded, as is further set out in our Speak-up Policy.
We will protect any colleague who in good faith believes they are victims of harassment or discrimination. This includes actions that can reasonably be considered offensive, intimidating or discriminatory, including sexual harassment, power harassment and bullying, whether physical, verbal or visual. We encourage colleagues to speak up against any incident that could be viewed as harassment or discrimination and to support those affected.
We encourage respect of the individual, their integrity and their dignity, by ensuring that the working environment and relations between colleagues are free of discrimination and harassment, whether based on race, religion, color, political convictions, sex, language, pregnancy, ethnic or national origin, civil state, social status, sexual orientation, handicap, age or otherwise.
We monitor compliance with these standards through a number of policies which we regularly train relevant employees on. We operate a personal development program in which we encourage all employees to participate. We operate short-term and long-term incentive plans to encourage attraction and retention of qualified personnel. We take a stance against all forms of discrimination and commit to promoting diversity, equity and inclusion as set out in our Code of Conduct and in our diversity, equity and inclusion policy.
Our Code of Conduct sets out core principles for the way we commit to important employee and social matters, including our commitment to maintaining the highest scientific and ethical standards in our research and development activities and complying with all internationally accepted standards that apply to our clinical trials, including the ICH Guidelines for Good Clinical Practice and the ethical principles articulated in the Declaration of Helsinki, as well as applicable local laws and regulations.
We believe open communication is critical to guaranteeing a positive work environment and our ultimate success. We understand that to make a difference we need to foster a culture of openness, where colleagues are encouraged to share their thoughts and ideas because diversity of thought leads to and empowers innovation. We actively listen to our colleagues and make sure all voices are heard.