Overview

Since our inception in 2008, we have focused most of our financial resources and efforts towards developing our SIMPLE ANTIBODY™ Platform and antibody engineering technologies, identifying potential product candidates, establishing process, development and manufacturing capabilities for our product candidates and advancing multiple discovery programs into the clinic. In 2022, we executed on our global launch of VYVGART our first-in-class neonatal FcRn blocker for intravenous use, which is now approved in the U.S., Japan, the EU, Canada, China and other EMEA jurisdictions for gMG.

In 2023, we launched VYVGART SC, the first-and-only neonatal FcRn blocker administered by subcutaneous injection. As of the year ended December 31, 2024, it is now approved in the U.S., Japan, the EU, Canada, China and other EMEA jurisdictions for gMG.

In 2024, we successfully started the sale of VYVGART SC for the treatment of CIDP in the U.S. and obtained approval in China and Japan. The commercialization of VYVGART IV and VYVGART SC generated global product net sales of $2.2 billion in 2024 as compared to $1.2 billion in 2023.

On our research and development, we continue towards advancing a deep pipeline of both clinical and preclinical-stage product candidates for the treatment of severe autoimmune diseases. Leveraging our technology suite and clinical expertise, we have advanced several candidates into late-stage clinical development and we currently have multiple programs in the discovery stage.

As of December 31, 2024 and December 31, 2023, we had cash and cash equivalents amounting to $1.5 billion and $2.0 billion, respectively; in addition to current financial assets of $1.9 billion and $1.1 billion, respectively.

Our Statement of Financial Position shows total assets of $6.2 billion for the year ended December 31, 2024, compared to $4.5 billion for the year ended December 31, 2023. The main reason for the material change in balance sheet total is the operational growth of the Company in the period.

Since our inception, we have incurred significant operating losses. For the year ended December 31, 2024 the Company recorded its first annual profit for the year of $833 million. In 2023, the Company recorded a loss for the year of $295 million. As of December 31, 2024, we had accumulated losses of $1.6 billion.

VYVGART and VYVGART SC are the only approved products we currently have.

We expect our expenses to continue to increase as we continue to execute registrational and proof-of-concept studies across efgartigimod, empasiprubart and ARGX-119, as well as the continued investment in our IIP. We anticipate that our expenses will increase if and as we execute on the following elements.

Research and development activities:

• Execute the registrational study of efgartigimod in three myositis subsets (IMNM, ASyS, and DM);
• Execute the Phase 3 clinical studies of efgartigimod in pediatric, seronegative and ocular MG;
• Execute the Phase 4 study switching CIDP patients from IVIg to VYVGART SC;
• Execute the confirmatory study of efgartigimod in primary ITP;
• Execute the registrational studies of efgartigimod in TED;
• Execute the registrational study of efgartigimod in SjD;
• Execute the Phase 2 study of efgartigimod in LN with our partner Zai Lab;
• Execute the Phase 2 studies of efgartigimod in AMR, SSc and AIE;
• Execute the Phase 3 studies of empasiprubart in MMN and CIDP;
• Execute the Phase 2 studies of empasiprubart in DGF and DM;
• Execute the Phase 1b/Phase 2a studies of ARGX-119 in CMS and ALS, respectively;
• Execute on the launch of Phase 2 study of ARGX-119 in SMA;
• Continue the research and development of our other clinical and preclinical-stage product candidates and discovery stage programs; and
• Seek regulatory approvals for any product candidates, including new indications, that successfully complete clinical trials.

Pre-commercial and commercial activities:

• Continue the build-out of our sales, marketing and distribution infrastructure and scale-up of manufacturing capabilities for the commercial expansion of VYVGART and VYVGART SC and any other product candidate, including new indications, for which we may obtain approval; and
• Expand our global reach enabling us to commercialize any product candidates, including new indications, for which we may obtain regulatory approval.

Other activities:

• Seek to enhance our technology platform and discover and develop additional product candidates;
• Maintain, expand and protect our intellectual property portfolio, including litigation costs associated with defending against alleged patent infringement claims;
• Add clinical, scientific, operational, financial and management information systems and personnel, including personnel to support our product development and potential future commercialization efforts; and,
• Experience any delays or encounter any issues, including failed studies, ambiguous clinical trial results, safety issues or other regulatory challenges.

We expect that the costs of development and commercialization might also increase due to current and future collaborations with research and development partners as well as commercial partners.