Annual Report 2025

Annual Report 2025

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

    the Company’s 2021 remuneration policy

  • 2025 20-F

    Form 20-F for the year ended December 31, 2025

  • 2025 Extraordinary General Meeting

    the extraordinary General Meeting held on November 18, 2025

  • 2025 General Meeting

    the AGM held on May 27, 2025

  • 2025 Remuneration Policy

    the Company’s 2025 remuneration policy, which was adopted at the 2025 Extraordinary General Meeting

  • 2025 Remuneration Report

    the Company’s 2025 remuneration report and compensation statement

  • 2026 General Meeting

    the AGM to be held on May 6, 2026

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

  • AChR

    anti-acetylcholine receptor

  • AChR-AB+

    AChR antibody positive

  • ADSs

    American depositary shares

  • AFM

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

  • AGM

    annual general meeting

  • AI Act

    Regulation (EU) 2024/1689

  • AIM

    autoimmune inflammatory myopathies

  • AKS

    the U.S. federal Anti-Kickback Statute

  • AML

    acute myleoid leukemia

  • AMP

    average manufacturer price

  • AMR

    antibody-mediated rejection

  • Annual Report

    this annual report

  • argenx or the Company

    argenx SE

  • Articles of Association

    our current articles of association

  • ASyS

    anti-synthetase syndrome

  • Audit and Compliance Committee

    the audit and compliance committee of the Board of Directors

b

  • BCCA

    Belgian Code on Companies and Associations

  • B-cell

    B-lymphocyte

  • Bilateral Shareholders and Stakeholders Contacts Policy

    our policy on bilateral contacts and dialogue with shareholders and stakeholders

  • BITC

    Belgian Income Tax Code

  • 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.

  • BPCIA

    the U.S. Biologics Price Competition and Innovation Act

  • Broteio

    Broteio Pharma B.V.

c

  • C2

    complement 2

  • CapEx

    capital expenditure

  • CBAs

    collective bargaining agreement

  • CEO

    chief executive officer

  • CFO

    chief financial officer

  • cGMPs

    current good manufacturing practices

  • CHMP

    Committee for Medicinal Products for Human Use

  • 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

  • CMC

    Chemistry, Manufacturing and Controls

  • CMIP

    Coupled Model Intercomparison Project

  • CMMI

    Center for Medicare and Medicaid Innovation authority

  • 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

  • Conditions for the Application of the Dividend Received Deduction Regime

    (i) the Belgian resident company holds (A) ADSs representing at least 10% of our share capital or (B) a participation with an acquisition value of at least €2,500,000 which (unless the shareholder is a Small Company) qualifies as “fixed financial asset” (financiële vaste activa). The condition relating to the qualification as “fixed financial asset” applies as of assessment year 2026; (ii) the ADSs representing our share capital have been or will be held in full ownership for an uninterrupted period of at least one year; and (iii) the conditions described in Article 203 of the BITC (relating to the taxation of the underlying distributed income and the absence of abuse), are met

  • COO

    chief operating officer

  • COSO

    Committee of Sponsoring Organizations of the Treadway Commission

  • CREATES

    the Creating and Restoring Equal Access to Equivalent Samples

  • CRO

    contract research organization

  • 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

  • CTD

    Clinical Trials Directive 2001/20/EC

  • 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 2025

  • DEFRA

    Department for Environment, Food and Rural Affairs

  • Deloitte

    Deloitte Accountants B.V.

  • DFSA

    Dutch Financial Supervision Act (Wet op het financieel toezicht)

  • DGF

    delayed graft function

  • DHS

    dehydrated hereditary stomatocytosis

  • Digital Technology

    Digital Technology function, previously known as Business Information System (BIS), is our all-encompassing IT division; driving innovation through data, AI, and strategic partnerships

  • Dividend Received Deduction

    deduction of 100% of the gross dividend received from taxable income

  • DM

    dermatomyositis

  • DMA

    double materiality assessment

e

  • E&C

    Ethics & Compliance

  • ECL

    expected credit loss

  • EEA

    European Economic Area

  • EEIO

    Environmentally Extended Input-Output

  • EFGCP

    European Forum for Good Clinical Practice

  • EMA

    European Medicines Authority

  • ENHANZE®

    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)

  • Environmental Delegated Act

    Delegated Regulation (EU) 2023/2486 of June 27, 2023

  • EPA

    U.S. Environmental Protection Agency

  • e-Privacy Directive

    Directive 2002/58/EC of the European Parliament and of the Council of July 12, 2002

  • EPS

    Profit or loss per share

  • 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, on February 27, 2023, on February 28, 2024, on 30 June 2025 and on 4 March 2026

  • ERM

    Enterprise Risk Management

  • ESG

    environmental, social and corporate governance

  • ESRS

    European Sustainability Reporting Standards

  • EU

    European Union

  • EU-IFRS

    IFRS® Accounting Standards (IFRS) as issued by the IASB and adopted by the EU

  • EU Pharmaceutical Legislation

    Regulations (EC) No. 726/2004, No. 141/2000, or No. 1901/2006

  • 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 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

  • Executive Director

    an executive director in the Board of Directors

  • EY

    EY Accountants B.V.

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

  • Fujifilm

    FUJIFILM Diosynth Biotechnologies Denmark ApS

g

  • GARP

    glycoprotein A repetitions predominant

  • 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)

  • GENEROUS

    GENErating cost Reductions fOr U.S. Medicaid

  • GHG

    greenhouse gas emissions

  • GLOBE

    Global Benchmark for Efficient Drug Pricing

  • GLPs

    good laboratory practices

  • gMG

    generalized myasthenia gravis

  • GMP

    good manufacturing practice

  • Greater China

    Mainland China, Hong Kong, Taiwan and Macau

  • Group

    argenx SE together with its subsidiaries

  • GUARD

    Guarding U.S. Medicare Against Rising Drug Costs

h

  • Halozyme

    Halozyme Therapeutics, Inc.

  • Hatch-Waxman Act

    the U.S. Drug Price Competition and Patent Term Restoration Act of 1984

  • HHS

    U.S. Department of Health and Human Services

  • HIPAA

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

  • HITECH

    Health Information Technology for Economic and Clinical Health Act of 2009

i

  • IASB

    International Accounting Standards Board

  • IEA

    International Energy Agency

  • IFRS

    IFRS® Accounting Standards

  • IgA

    Immunoglobulin A

  • IgG

    Immunoglobulin G

  • IgM

    Immunoglobulin M

  • IIP

    immunology innovation program

  • IMM

    irreversible morbidity or mortality

  • IMNM

    immune-mediated necrotizing myopathy

  • IND

    investigational new drug

  • IPCC

    Intergovernmental Panel on Climate Change

  • IRA

    Inflation Reduction Act

  • IRB

    institutional review board

  • IROs

    impacts, risks, and opportunities

  • ISAE

    International Standard on Assurance Engagements

  • ISMS

    Information Security and Management System

  • ITP

    immune thrombocytopenia

  • IV

    intravenous

  • IVIg

    intravenous IgG

k

  • KPI

    key performance indicator

l

  • LEI

    European legal entity identifier number

  • Lonza

    Lonza Sales AG

  • LTIP

    Long term incentive plan

m

  • MA

    marketing authorization

  • MAA

    marketing authorization application

  • mAb

    monoclonal antibody

  • MAH

    marketing authorization holder

  • 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

  • MFN

    most favored nation

  • MG

    myasthenia gravis

  • MG-ADL

    Myasthenia Gravis Activities of Daily Living

  • MHLW

    Ministry of Health, Labour and Welfare

  • MMN

    multifocal motor neuropathy

  • MN

    membranous nephropathy

  • MSE

    minimal symptom expression

  • 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

  • New Capital Gains Tax

    the capital gains tax on financial assets (such as the ADSs) for capital gains realized as from January 1, 2026 as agreed to be introduced by the Belgian federal government

  • new Product Liability Directive

    Directive (EU) 2024/2853

  • 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

  • NIS2

    Directive (EU) 2022/2555 on Network and Information Security

  • NMJ

    neuro muscular junction

  • Non-Executive Director

    a non-executive director in the Board of Directors

  • Non-FAMP

    Non-Federal Average Manufacturer Price

  • NRDL

    National Reimbursement Drug List

o

  • OCI

    other comprehensive income

  • Ocular MG

    ocular myasthenia gravis

  • OFPs

    organizations for financing pensions

  • OLE

    open-label extension

  • OncoVerity

    OncoVerity, Inc

  • OpEx

    operating expenditure

p

  • PAA

    pre-approval access program

  • PD

    pharmacodynamic

  • PDUFA

    Prescription Drug User Fee Act

  • PFIC

    passive foreign investment company

  • PFS

    prefilled syringe

  • PG&S

    Purchased Goods and Services

  • 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

  • PK

    pharmacokinetic

  • PMDA

    Pharmaceuticals and Medical Devices Agency (Japan)

  • POC

    proof-of-concept

  • PREA

    Pediatric Research Equity Act of 2003, as amended

  • PSP

    Pediatric Study Plan

  • PSU

    performance share unit

  • PTA

    Post-Trial Access

r

  • R&D

    research & development

  • Reference Date

    30 calendar days preceding the 15th day of the month in which the grant of stock option occurs

  • Relevant Regulatory Authorities

    the MHRA, EMA, FDA, MHLW

  • REMS

    risk evaluation and mitigation strategy

  • Remuneration and Nomination Committee

    remuneration and nomination committee of the Board of Directors

  • RSU

    restricted stock unit

s

  • SAAR

    specific anti-abuse rule

  • SASB

    Sustainability Accounting Standards Board

  • SBTi

    Science Based Targets initiative

  • SC

    subcutaneous

  • SEC

    the U.S. Securities and Exchange Commission

  • Securities Act

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

  • Senior Management Team

    the Company’s senior management team consisting of our CEO and senior personnel reporting directly to the CEO

  • Seronegative gMG

    Seronegative generalized myasthenia gravis

  • Significant Stake

    a participation of at least 20% in the company whose shares are being transferred

  • SjD

    sjögren’s disease

  • SMA

    spinal muscular atrophy

  • Small Company

    a small company (kleine vennootschap), being a company that, on the balance sheet date of the last completed financial year, has not exceeded more than one of the following thresholds on a consolidated basis for two consecutive financial years: (i) an average annual number of 50 employees, (ii) an annual turnover excluding VAT of EUR 11,250,000 and (iii) a balance sheet total of €6,000,000 (cf. Article 2, §1, 5°, c)bis of the BITC in conjunction with Article 1:24, §1 to §6 of the BCCA

  • Societas Europaea or SE

    a Dutch European public company with limited liability

t

  • Taxonomy Regulation

    Regulation (EU) 2020/852

  • TCFD

    Task Force on Climate-related Financial Disclosures

  • TED

    thyroid eye disease

  • third-party partner

    includes suppliers and contractors

  • 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

  • TTW

    tank-to-wheel

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

  • UNGPs

    UN Guiding Principles on Business and Human Rights

  • 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

    Board of Regents of the University of Texas System

v

  • VBA

    Value Based Agreements

  • V-regions

    antibody variable regions

  • VYVDURA

    VYVDURA®

  • VYVGART

    VYVGART® (efgartigimod alfa-fcab)

  • VYVGART HYTRULO

    VYVGART HYTRULO™

  • VYVGART SC

    VYVGART subcutaneous (efgartigimod alfa + hyaluronidase qvfc)

w

  • WBCSD

    World Business Council for Sustainable Development

  • we, us or our

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

  • WFH

    Work from Home

  • WTT

    well-to-tank

  • WTW

    well-to-wheel

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