Overview
2025 was a transformative year for argenx as we advanced our mission to deliver innovation to patients. Our commercial execution reached new heights with the successful expansion of VYVGART, the first-in-class FcRn blocker, which now offers three administration options, including self-injection with the PFS. The PFS launch began in the U.S. in April of this year, followed by the EU and Japan.
This evolution reflects our commitment to innovating the patient experience in our two blockbuster indications and pursuing the broadest label for our medicines. The commercialization of the VYVGART franchise generated global product net sales of $4.2 billion in 2025 as compared to $2.2 billion in 2024.
Beyond commercial achievements, we continued to execute on a pipeline with breadth and depth, reinforcing our leadership in immunology. We announced positive topline results from the ADAPT SERON clinical trial of VYVGART in Seronegative gMG, further expanding the potential reach of VYVGART. In December of this year, we filed the Seronegative gMG supplemental BLA in pursuit of the broadest MG label of any biologic. In January 2026, the FDA has accepted for priority review a supplemental BLA for VYVGART for the treatment of adults with Seronegative gMG. The application has been granted an expected PDUFA date of May 10, 2026.
Additionally, we showcased innovation through our R&D webinar highlighting adimanebart (ARGX-119), a first-in-class agonistic antibody targeting and MuSK to promote maturation and stabilization of the neuromuscular junction, with advancement in CMS. These programs underscore our strategy of entrepreneurial clinical development and commitment to addressing unmet needs across a spectrum of autoimmune and neuromuscular diseases.
Looking ahead, in 2026 our teams will strive to continue delivering VYVGART to as many patients as possible. We also expect results to be delivered on four registrational readouts in 2026 and two more in 2027:
- Topline results expected in the first quarter of 2026 for Ocular MG (ADAPT OCULUS) with efgartigimod
- Topline results expected in the third quarter of 2026 from ALKIVIA clinical trial evaluating three myositis subsets IMNM, ASyS and DM with efgartigimod
- Topline results expected in the fourth quarter of 2026 for EMPASSION clinical trial (MMN) with empasiprubart
- Topline results expected in the fourth quarter of 2026 for primary ITP (ADVANCE-NEXT) with efgartigimod
- Topline results from UNITY clinical trial (SjD) expected in second half of 2027 with efgartigimod
- Topline results from EMVIGORATE clinical trial for empasiprubart (CIDP) expected in second half of 2027
Our Vision 2030 sets the goal to have five new molecules in Phase 3, ten labeled indications, and 50,000 patients on treatment by 2030. It provides a clear roadmap for scaling impact on patients, physicians, and the innovation ecosystem we’re shaping. Achieving this vision will be driven by our core competencies: building winning molecules, entrepreneurial clinical development, and delivering a differentiated patient experience. We plan to continue to prioritize innovation, expand global access, and leverage partnerships to accelerate growth.
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, our ecosystem of partnerships and clinical expertise, we have advanced several candidates into late-stage clinical development, and we currently have multiple programs in the discovery stage. argenx continues to target one Investigational New Drug (IND) application per year in generating a world-class pipeline.
We enter the next phase of our ambitious innovation agenda with a solid balance sheet, providing financial strength and flexibility to invest confidently in our pipeline and global expansion. As of December 31, 2025 and December 31, 2024, we had cash and cash equivalents amounting to $3.5 billion and $1.5 billion, respectively; in addition to current financial assets of $0.9 billion and $1.9 billion, respectively.
As outlined in “Section 6.1.1 Consolidated Statements of Financial Position”, the Company held total assets of $8.7 billion as of the year ended December 31, 2025, compared to $6.2 billion as of the year ended December 31, 2024. The main reason for the material change in balance sheet total is the operational growth of the Company in the period.
For the year ended December 31, 2025 the Company recorded a second year of profitability with$1,292 million compared to our first annual profit for the year ended December 31, 2024 in the amount of $833 million. This was the Company’s first year of operational profitability. As of December 31, 2025, we had accumulated losses of $0.3 billion.
We expect our expenses to continue to increase as we continue to execute registrational and proof-of-concept studies across efgartigimod, empasiprubart and adimanebart, as well as the continued investment in our IIP. We anticipate that our expenses will increase if and as we execute on our research and development activities, pre-commercial and commercial activities and various other activities.
We are actively engaged in the maintenance, expansion and protection of our intellectual property portfolio, including litigation costs associated with defending against alleged patent infringement claims or enforcing our IP rights against third parties. 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.