Annual Report 2023

Annual Report 2023

Definitions

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 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

a

  • AAV

    ANCA-associated vasculitis

  • 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

  • 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 Financiële Markten)

  • Agomab

    Agomab Therapeutics NV

  • AKS

    the U.S. federal Anti-Kickback Statute

  • Alexion

    Alexion Pharmaceuticals, Inc.

  • 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 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

  • 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.

  • 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

c

  • 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

  • Chugai

    Chugai Pharmaceutical Co., Ltd.

  • 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)

d

  • DCC

    Dutch Civil Code (Burgerlijk Wetboek)

  • DCGC

    the Dutch Corporate Governance Code 2022

  • Deloitte

    Deloitte Accountants B.V.

  • DFSA

    Dutch Financial Supervision Act (Wet op het financieel toezicht)

  • DGF

    delayed graft function

  • DHS

    dehydrated hereditary stomatocytosis

  • 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

e

  • ECDRP

    European Commission Decision Reliance Procedure

  • ECL

    expected credit loss

  • EEA

    European Economic Area

  • Elektrofi

    Elektrofi, 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 2000/12/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. Securities Exchange Act of 1934, as amended

f

  • 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

g

  • 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-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

h

  • Halozyme

    Halozyme Therapeutics, 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

i

  • 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

  • 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

j

  • Janssen

    Janssen Pharmaceuticals, Inc.

  • Johnson & Johnson

    Johson & Johnson Innovation, Inc.

k

  • KPI

    key performance indicator

l

  • 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

m

  • 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.

  • 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

n

  • 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

o

  • OCI

    other comprehensive income

  • OFPs

    organizations for financing pensions

  • OIG

    the Office of Inspector General

  • OLE

    open-label extension

  • OncoVerity

    OncoVerity, Inc.

  • OpEx

    operating expenditure

p

  • 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. 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

q

  • QA

    quality assurance

  • QMG

    quantitative myasthenia gravis

r

  • 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. Hoffman-La Roche AG

  • RSUs

    restricted stock units

s

  • 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. 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

    Sjögren’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™

t

  • Targacept

    Targacept Inc.

  • 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-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

  • U.S.

    the United States of America

  • U.S. 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

    Université 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

v

  • 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. (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™

w

  • we, us or our

    argenx SE together with its wholly owned subsidiaries and, as applicable, its former wholly owned subsidiaries

z

  • 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