argenx Q3 2024 Financial Results and Business Update

Argenx SE, a leading global immunology company based in Amsterdam, reported its financial outcomes for the third quarter of 2024 and provided a business update. The company, renowned for its commitment to enhancing the lives of individuals suffering from severe autoimmune diseases, highlighted significant advancements and performance metrics during this period.

The company's global net product sales reached $573 million in the third quarter, driven primarily by the commercialization of VYVGART (efgartigimod alfa-fcab). This product is a first-in-class antibody fragment targeting the neonatal Fc receptor (FcRn). VYVGART is currently approved for intravenous and subcutaneous administration across several indications globally, including generalized myasthenia gravis (gMG), primary immune thrombocytopenia (ITP) in Japan, and chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S.

Chief Executive Officer, Tim Van Hauwermeiren, emphasized the positive impact VYVGART has had on patients and the company’s expansion within the gMG and CIDP therapeutic areas. He noted milestones such as the reduction in steroid use among patients and the rapidly growing patient base for CIDP treatment, with over 300 patients on therapy by the end of the third quarter.

Argenx's Vision 2030 initiative aims to transform autoimmune disease treatment by leveraging its expertise in FcRn biology. The strategy includes efforts to reach at least 50,000 patients worldwide, develop ten labeled indications, and bring five new molecules into Phase 3 trials by 2030. This vision underscores the company’s commitment to innovation and expanding its robust pipeline of differentiated antibody candidates.

VYVGART has seen several regulatory successes and ongoing reviews, reflecting its global expansion strategy. These include approval for gMG treatment in Switzerland, pending regulatory decisions in Australia and Saudi Arabia, and anticipated review in South Korea by 2025. Additionally, multiple regulatory submissions for VYVGART SC for CIDP are under review in Japan, Europe, and China, with decisions expected in 2025 and a submission in Canada planned by the end of 2024. VYVGART SC is now reimbursed in 11 European countries, with new agreements in France, Luxembourg, and Belgium.

Argenx’s pipeline continues to grow, with efgartigimod in development for 15 indications and empasiprubart, a first-in-class C2 inhibitor, under evaluation for conditions like multifocal motor neuropathy (MMN) and dermatomyositis (DM). The company is also developing ARGX-119, a muscle-specific kinase (MuSK) agonist, for congenital myasthenic syndrome (CMS) and amyotrophic lateral sclerosis (ALS). Several other studies are in progress, including those for thyroid eye disease (TED), primary Sjögren’s disease (SjD), and primary ITP.

Financially, Argenx reported a total operating income of $589 million for the third quarter of 2024, a significant increase from $340 million in the same period in 2023. This growth was fueled by the net product sales of VYVGART, which nearly doubled year-over-year. Research and development expenses also rose, reflecting the company's investment in expanding its clinical and preclinical pipeline. Selling, general, and administrative expenses increased as well, driven by the costs associated with the global commercialization efforts for VYVGART.

The company’s financial health remains strong, with cash, cash equivalents, and current financial assets totaling $3.4 billion as of September 30, 2024. Despite the higher operating expenses, Argenx achieved a net income of $91 million for the quarter, a substantial turnaround from a net loss of $73 million in the third quarter of 2023.

Argenx continues to push the boundaries in immunology through its Immunology Innovation Program (IIP), which aims to sustain long-term pipeline growth. The program has led to the nomination of four new pipeline candidates focusing on various targets crucial to immune system function and disease modulation.

In summary, Argenx SE's third quarter of 2024 was marked by robust financial performance, strategic regulatory advancements, and continued innovation within its pipeline, setting a strong foundation for future growth and impact in the field of immunology.