Annual Report 2025

Annual Report 2025

Company Profile

General

At argenx, we are defining the future of immunology with an entrepreneurial mindset, bringing together agility, focus, and a collaboration in all that we do. We are a global, commercial-stage, entrepreneurial science company. Our co-creative discovery engine, the Immunology Innovation Program, is powered by partnerships between leading disease biologists and our antibody engineers, enabling us to advance with urgency a robust pipeline of differentiated therapies for severe diseases. We are committed to accelerating innovation, breaking down barriers to access, and building lasting trust through transparency and evidence. Our dynamic pipeline and evidence-driven approach position argenx to deliver sustainable growth and long-term value for patients, healthcare providers, and investors alike.

We developed and commercialized the first approved FcRn blocker and we are evaluating efgartigimod in multiple serious autoimmune diseases. We are also advancing our second and third assets, empasiprubart, a complement 2 (C2) inhibitor and adimanebart, a muscle-specific kinase (MuSK) agonist, both of which are now in Phase 3 clinical trials.

Our legal and commercial name is argenx SE. We were incorporated under the laws of the Netherlands on April 25, 2008, as a private company with limited liability (besloten vennootschap met beperkte aansprakelijkheid). From incorporation until August 28, 2009, our research and development activities were initially performed in the Netherlands, then Belgium, by argenx N.V. and its legal predecessors. Since August 28, 2009, all our research and development activities have been performed by our wholly-owned subsidiary, argenx BV, under a license provided by argenx N.V. Throughout this time, argenx BV assigned all resulting intellectual property to argenx N.V. On May 28, 2014, we converted to a Dutch public company with limited liability (naamloze vennootschap). On April 26, 2017, we converted to a Dutch European public company with limited liability (Societas Europaea or SE). On May 5, 2017, we transferred the legal ownership of all intellectual property rights of argenx SE to argenx BV, effective retroactively as of January 1, 2017. As a result, since January 1, 2017, (i) argenx BV holds all legal and economic ownership of our intellectual property rights, and (ii) the research and development agreement between argenx SE and argenx BV has been terminated.

Our official seat is in Amsterdam, the Netherlands, and our registered office is at Laarderhoogtweg 25, 1101 EB Amsterdam, the Netherlands. We are registered with the trade register of the Dutch Chamber of Commerce under number 24435214. Our European legal entity identifier number (LEI) is 7245009C5FZE6G9ODQ71. Our telephone number is +31 (0) 10 70 38 441. Our website address is www.argenx.com. This website is not incorporated by reference in this Annual Report. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at www.sec.gov. The registered agent for service of process in the U.S. is CT Corporation System, with an address at 111 8th Avenue, New York, NY 10011.

Our ordinary shares are listed on the regulated market of Euronext Brussels in Belgium under ISIN NL0010832176 under the symbol “ARGX” since 2014 and ADSs, each representing one ordinary share in argenx (or a right to receive such share), are listed on the Nasdaq Global Select Market (Nasdaq) under the symbol “ARGX” since 2017.

argenx SE is the parent entity of the Group and the sole shareholder of:

  • argenx B.V., a private company with limited liability (besloten vennootschap/société à responsabilité limitée) incorporated under the laws of Belgium, having its registered seat in Zwijnaarde, Belgium and its address at Industriepark-Zwijnaarde 7, 9052 Zwijnaarde, Belgium. argenx B.V. is the sole shareholder of:

    • argenx Australia Pty. Ltd., incorporated under the laws of Australia, having its registered office and address at Level 14, 2 Riverside Quay, Melbourne VIC 3006, Australia;

    • argenx Austria Services GmbH, incorporated under the laws of Austria, having its registered office and address at Graben 19, 4th & 5th floor Vienna A-1010 Austria;

    • argenx Benelux B.V. (prior to October 31, 2022 known as argenx IIP BV), incorporated under the laws of Belgium, having its registered seat in Zwijnaarde, Belgium and its address at Industriepark-Zwijnaarde 7, 9052 Zwijnaarde, Belgium;

    • argenx Biotechnology (Shanghai) Co., Ltd., incorporated under the laws of China, having its registered office and address at Room 301-3, No. 481-479 Ping Xing Guan Road, Jingan District, Shanghai, China;

    • argenx Brasil Produtos Farmacêuticos Ltda, incorporated under the laws of Brazil, having its registered office in Sao Paulo, Brazil and its address at Estrade da Lagoinha, 489 – Bloco 4, Bairro Lagoa CEP 06730-000, City of Vargem Grande Paulista, Sao Paulo, Brazil;

    • argenx Canada Inc., incorporated under the laws of Ontario, having its registered office in Ontario, Canada and its address at 6220 Highway 7, Woodbridge, Ontario, Canada, L4H4G3;

    • argenx France SAS, incorporated under the laws of France, having its registered office in Issy-les-Moulineaux, France and its address at 24 rue Gouverneur Général Félix Éboué, 92130 Issy-les-Moulineaux, France;

    • argenx Germany GmbH, incorporated under the laws of Germany, having its registered office in Munich, Germany and its address at Konrad-Zuse-Platz 8, 81829 Munich, Germany;

    • argenx Italy S.r.l., incorporated under the laws of Italy, having its registered office in Milan, Italy and its address at Largo Francesco Richini 6 CAP, 20122 Milan, Italy;

    • argenx Japan KK., incorporated under the laws of Japan, having its registered office in Tokyo, Japan and its address at HULIC JP Akasaka Building 2-5-8, Akasaka, Minato-ku, Tokyo, 107-0052, Japan;

    • argenx Netherlands Services B.V., incorporated under the laws of the Netherlands having its registered office at Laarderhoogtweg 25, 1101 EB Amsterdam, the Netherlands;

    • argenx Spain S.L., incorporated under the laws of Spain, having its registered office in Madrid, Spain and its address at Paseo dela Castellana 200, Planta 8a, Oficina 819, 28046 Madrid, Spain, with the branch office: argenx Spain S.L. – Sucursal em Portugal, organized under the laws of Portugal, having its registered office and address at Palácio Sottomayor, Rua Sousa Martins, nº1, 1º esquerdo 1050 217, Lisboa, Portugal;

    • argenx Switzerland, S.A., incorporated under the laws of Switzerland, having its registered office in Geneva, Switzerland and its address at Rue du Pré-de-la-Bichette 1, 1202 Geneva, Switzerland;

    • argenx UK Ltd., incorporated under the laws of the UK, having its registered office in Gerrards Cross, UK and its address at Spaces Gerrards Cross Chalfont Park, Building 1 Gerrards Cross, SL9 0BG, UK;

    • argenx US, Inc., incorporated under the laws of the state of Delaware, U.S., having its registered office in Wilmington, Delaware and its address at 33 Arch Street, Boston, Massachusetts 02110 and;

    • Broteio Pharma B.V., incorporated under the laws of the Netherlands, having its registered office at Laarderhoogtweg 25, 1101 EB Amsterdam, the Netherlands.

The following chart provides an overview of the Group as of the date of this Annual Report. Percentages refer to both the share of capital and voting rights.

argenx Corporate Legal Structure

argenx Corporate Legal Structure (graphic)

Overview

Our Medicines

VYVGART and VYVGART HYTRULO is a first-and-only immunoglobulin G (IgG) Fc-antibody fragment that targets the FcRn. It is approved for the treatment in three indications, including gMG and CIDP globally and ITP in Japan (as VYVDURA).

Our Pipeline

  • efgartigimod is an IgG1 antibody Fc fragment that has been engineered for increased affinity to FcRn compared to endogenous IgG. Efgartigimod selectively reduces IgG by blocking FcRn-mediated IgG recycling without impacting antibody production or affecting other parts of the immune system. It is approved in three indications, including gMG, CIDP and ITP, and is being evaluated in more than ten additional serious autoimmune indications.

  • empasiprubart (C2 inhibitor) is a novel complement inhibitor targeting C2, blocking the function of both the classical and lectin pathways while leaving the alternative pathway intact. We believe empasiprubart has the potential to be a pipeline-in-a-product candidate and is being evaluated in two indications currently in Phase 3 clinical trials.

  • adimanebart (MusK agonist): adimanebart is an agonist SIMPLE ANTIBODY™ to the MuSK receptor with potential in multiple neuromuscular indications. It is currently in clinical trials for CMS (Phase 3 clinical trial) and SMA (Phase 2).

  • Earlier Stage Programs:

    • Two future FcRn molecules are progressing: ARGX-213, an FcRn-targeted antibody engineered for half-life extension and sustained IgG reduction, and ARGX-124, a first-in-class FcRn pipeline candidate.

    • ARGX-109 (targeting IL-6) and ARGX-121 (a first-in-class molecule targeting immunoglobulin A (IgA)) are also progressing.

    • Entered into a research collaboration with Tensegrity Pharma, including an option for future acquisition, to advance Tensegrity’s lead program TSP-101 in autoimmune disease and other indications.

    • Three new molecules expected to enter Phase 1 clinical trials in 2026, including ARGX-118, a first-in-class molecule targeting Galectin-10, ARGX-125, a first-in-class bispecific antibody, and TSP-101, targeting Fn14.

  • In addition to our wholly-owned pipeline, we have candidates that emerged from our IIP that we out-licensed to a partner for further development and for which we have milestone, royalty or profit-share agreements. These candidates include, amongst others: cusatuzumab (anti-CD70 antibody – OncoVerity), ARGX-112 (LP-0145 – anti-IL-22R antibody – LEO Pharma), ARGX-114 (AGMB-101 – agonistic anti-MET antibody – Agomab) and ARGX-115 (ABBV-151 – anti-GARP antibody – AbbVie).

Immunology Innovation Program (IIP)

Our IIP is the engine behind our robust and expansive pipeline. By fostering deep, ongoing collaboration between leading academic researchers and our in-house antibody engineers, we aim to translate breakthrough science into first-in-class therapies across multiple indications. This co-creation model has enabled every candidate in our wholly owned and partnered pipelines to emerge from IIP collaborations, underscoring our ability to identify and advance novel targets with speed and precision.

Our approach is designed for scale and sustainability: we run parallel development programs, optimize trial design for efficiency, and maintain a relentless focus on unmet patient needs. This strategy has delivered measurable results – accelerating our path to profitability, driving strong commercial growth, and positioning argenx as a leader in immunology innovation. By integrating the aspirations of patients and the insights of healthcare professionals into every stage of discovery and development, we are not only building a differentiated pipeline but also setting new standards for impact and value creation in the sector.

We bring to the collaboration our unique suite of antibody discovery and antibody engineering technologies and experience in clinical development to complement our partners’ expertise in disease and target biology. Our suite of technologies includes amongst others our SIMPLE ANTIBODY™ platform technology and NHANCE™, ABDEG™, POTELLIGENT®, and DHS mutations that focus on engineering the Fc region of antibodies in order to augment their intrinsic therapeutic properties.

Our Suite of Technologies

  • SIMPLE ANTIBODY™ platform technology: Our proprietary SIMPLE ANTIBODY™ platform technology, based on the powerful llama immune system, allows us to exploit novel and complex disease biology targets. The platform sources antibody variable regions (V-regions) from the immune system of outbred llamas, each of which has a different genetic background. The llama produces highly diverse panels of antibodies with a high human homology, or similarity, in their V-regions when immunized with targets of human disease. Our SIMPLE ANTIBODY™ platform technology allows us to access and explore a broad target universe while potentially minimizing the long timelines associated with generating antibody candidates using traditional methods.

  • NHANCE™, ABDEG™, POTELLIGENT®, and DHS mutations focus on engineering the Fc region of antibodies in order to augment their intrinsic therapeutic properties. In addition, we obtained a non-exclusive research license and option from Chugai Pharmaceutical Co., Ltd. (Chugai) for the SMART-Ig® (“Recycling Antibody” and part of “Sweeping Antibody”) and ACT-Ig® (Antibody half-life extending) technologies. These technologies are designed to enable us to expand the therapeutic index of our product candidates, which is the ratio between toxic and therapeutic dose, by potentially modifying their half-life, tissue penetration, rate of disease target clearance and potency.