Annual Report 2022

Annual Report 2022


The following explanations are intended to assist the general reader to understand certain terms used in this Annual Report. The definitions set out below apply throughout this Annual Report, unless the context requires otherwise.

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  • 2021 General Meeting

    annual general meeting of shareholders held in 2021


  • AbbVie

    AbbVie, Inc.

  • 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

  • AChR

    anti-acetylcholine receptor

  • AChR-AB+

    AChR antibody positive

  • ADCC

    antibody-dependent cell-mediated cytotoxicity

  • ADS

    American Depositary Share

  • AFM

    the Dutch Authority for the Financial Markets (Stichting Autoriteit Financiële Markten)

  • AgomAb

    AgomAb Therapeutics NV

  • AKS

    the U.S. federal Anti-Kickback Statute

  • 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 or the Company

    argenx SE

  • Article 8 CDR

    Commission Delegated Regulation (EU) 2021/2178 of 6 July 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 with IQVIA

  • ASyS

    anti-synthetase syndrome

  • AV

    anti-neutrophil cytoplasmic antibody-associated Vasculitis


  • B-cell

    B-lymphocyte producing a specific antibody

  • BioWa

    BioWa, Inc

  • BioWa Agreement

    non-exclusive license agreement

  • BLA

    biologics license application

  • 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.

  • BP

    bullous pemphigoid


    the U.S. Biologics Price Competition and Innovation Act

  • Broteio

    Broteio Pharma B.V.

  • Broteio Agreement

    collaboration with Broteio


  • C2

    component 2

  • CapEx

    capital expenditure

  • CBA

    a collective bargaining agreement

  • CDR

    complementary determining region

  • CEO

    chief executive officer

  • cGMPs

    current good manufacturing practices

  • CHMP

    Committee for Medicinal Products for Human Use

  • Chugai

    Chugai Pharmaceutical Co., Ltd.

  • CIDP

    chronic inflammatory demyelinating polyneuropathy

  • Climate Delegated Act

    Commission Delegated Regulation (EU) 2021/2139 of 4 June 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

    Centers for Medicare & Medicaid

  • 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

  • CRO

    contract research organization

  • CTA

    clinical trial application


  • DCC

    Dutch Civil Code (Burgerlijk Wetboek)

  • DCGC

    the Dutch Corporate Governance Code 2016, dated December 8, 2016

  • Deloitte

    Deloitte Accountants B.V.

  • DFSA

    Dutch Financial Supervision Act (Wet op het financieel toezicht)

  • DGF

    delayed graft function

  • DHS

    dehydrated hereditary stomatocytosis

  • DM



  • ECL

    expected credit loss

  • EEA

    European Economic Area

  • Elektrofi

    Elektrofi, Inc.

  • Elektrofi Agreement

    collaboration and license agreement with Elektrofi

  • EMA

    European Medicines Authority


    ENHANZE technology

  • ENHANZE License Agreement

    in-license agreement with Halozyme, Inc.

  • Enterprise Chamber

    the Dutch Enterprise Chamber of the Amsterdam Court of Appeal (Ondernemingskamer van het Gerechtshof te Amsterdam)

  • 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


    elements to assure safe use

  • EU

    European Union


    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 2000/12/EC of the European Parliament and of the Council and repealing Council Directive 93/22/EEC (MiFID II)

  • EU Taxonomy Regulation

    Regulation (EU) 2020/852 of the European Parliament and of the Council of 18 June 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088

  • Exchange Act

    the U.S. 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


    Food and Drug Omnibus Reform Act

  • FSS

    Federal Supply Schedule

  • Fujifilm

    FUJIFILM Diosynth Biotechnologies Denmark ApS


    fair value through other comprehensive income


    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)

  • Genpharm

    Genpharm Services FZ-LLC

  • Genpharm

    partnership agreement with Genpharm Services FZ-LLC

  • 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, Inc.

  • 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


    the U.S. federal Health Insurance Portability and Accountability Act of 1996


    the Health Information Technology for Economic and Clinical Health Act of 2009

  • HRSA

    Health Resources and Services Administration


  • IAVI

    International AIDS Vaccine Initiative

  • 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


    Inflammatory Neuropathy Cause and Treatment

  • IND

    investigational new drug



  • IRA

    Inflation Reduction Act

  • IRB

    institutional review board

  • I-RODS

    Inflammatory Rasch-built Overall Disability Scale

  • ISTs

    immunosuppressive therapies

  • ITP

    immune thrombocytopenia

  • IV


  • IVIg

    intravenous IgG

  • IWG

    International Working Group


  • Janssen

    Janssen Pharmaceuticals, Inc.


  • KPI

    key performance indicator


  • LEI

    European legal entity identifier number

  • LEO Pharma

    Pharma LEO Pharma A/S

  • LEO Pharma Collaboration Agreement

    collaboration agreement 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

  • MAD

    multiple ascending dose

  • 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

  • Medison

    Medison Pharma Ltd.

  • Medison Agreement

    exclusive distribution agreement with Medison Pharma Ltd. To commercialize efgartigimod in Israel

  • Medison Multi-Regional Agreement

    multi-regional agreement with Medison Pharma Ltd. to commercialize efgartigimod in 14 countries

  • MET

    mesenchymal-epithelial transition factor

  • MG

    myasthenia gravis

  • 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

  • NDA

    new drug application

  • NHI

    National Health Insurance

  • NHSA

    National Healthcare Security Administration

  • NK

    natural killer

  • Non-FAMP

    Non-Federal Average Manufacturer Price

  • NYU

    New York University

  • NYU and LUMC Agreement

    collaboration and exclusive license agreements with NYU Langone Health and LUMC


  • OCI

    other comprehensive income

  • OIG

    the Office of Inspector General

  • OncoVerity

    OncoVerity, Inc.

  • OpEx

    operating expenditure


  • PAA

    pre-approval access program

  • PBM

    pharmacy benefit managers


    Post-COVID-19 Postural Orthostatic Tachycardia Syndrome

  • PD


  • PDAI

    pemphigus disease area index


    Prescription Drug User Fee Act

  • PF

    pemphigus foliaceous

  • Pharmaceutical and Medical Device Act

    the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices

  • PHSA

    the U.S. Public Health Service Act

  • 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


  • PMDA

    Pharmaceuticals and Medical Devices Agency (Japan)

  • POTELLIGENT License Agreements

    non-exclusive license agreements for POTELLIGENT CHOK1SV with BioWa and Lonza

  • PRC

    the People’s Republic of China

  • PREA

    Pediatric Research Equity Act of 2003, as amended

  • Primary SjS

    Sjögren’s syndrome

  • PRV

    Priority Review Voucher

  • PV

    pemphigus vulgaris

  • PVAS

    pemphigus vulgaris activity score


  • QA

    quality assurance

  • QMG

    quantitative myasthenia gravis


  • RDL

    Reimbursable Drug List

  • Relevant Regulatory Authorities

    the MHRA, EMA, FDA, MHLW

  • REMS

    risk evaluation and mitigation strategy

  • Roche

    F. Hoffman-La Roche AG

  • RSUs

    restricted stock units


  • SC


  • SEC

    the U.S. Securities and Exchange Commission

  • Securities Act

    the U.S. Securities Act of 1933, as amended

  • Shire

    Shire AG, now known as Shire International GmbH

  • Shire Agreement

    collaboration agreement with Shire AG, now known as Shire International GmbH

  • SLE

    systemic lupus erythematosus

  • Sopartec

    Sopartec S.A.

  • System

    Lonza Sales AG’s proprietary glutamine synthetase gene expression system known as GS Xceed™


  • 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-β

    transforming growth factor beta

  • TIS

    total improvement score

  • 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

  • UCHealth

    University of Colorado Health

  • UCL

    Université Catholique de Louvain

  • UK

    the United Kingdom


    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


    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 concluded with VIB

  • V-regions

    antibody variable regions



  • VYVGART Approved Countries

    U.S., Japan, all 27 EU Member States plus Iceland, Norway and Liechtenstein


  • 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

  • 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