argenx Announces Q1 2024 Financial Results and Business Update

Argenx SE, an international immunology firm, has reported its financial performance for the first quarter of 2024 and provided business updates. The company, listed on Euronext and Nasdaq under the ticker ARGX, is steadfast in its mission to improve the lives of individuals afflicted by severe autoimmune diseases.

CEO Tim Van Hauwermeiren highlighted the substantial advancements made by the argenx team in the current year, underscoring their dedication to delivering safe and effective treatments. A major contributor to their recent success is VYVGART SC, which has expanded the company's prescriber base and reached new patients, positioning argenx for continued success.

In the first quarter of 2024, global net product sales reached $398 million. The U.S. Food and Drug Administration (FDA) is currently reviewing a supplemental Biologics License Application (sBLA) for CIDP, with a target action date set for June 21, 2024. Moreover, argenx plans to submit a filing for a pre-filled syringe (PFS) in the second quarter of 2024. A conference call to discuss these updates will be hosted by management.

VYVGART (efgartigimod alfa-fcab), a pioneering antibody fragment targeting the neonatal Fc receptor (FcRn), has become the first FcRn antagonist approved for two indications. It is authorized for the treatment of generalized myasthenia gravis (gMG) in over 30 countries and for primary immune thrombocytopenia (ITP) in Japan. Notably, VYVGART SC is approved in the U.S., Japan, and Europe, making it the only gMG treatment accessible as both an intravenous (IV) and subcutaneous (SC) injection.

Argenx has seen significant achievements with VYVGART, including approval in Japan for ITP in March 2024, marking the first global approval for this condition. Additional regulatory decisions for VYVGART and VYVGART SC are anticipated in 2024 across several countries, including Switzerland, Australia, Saudi Arabia, South Korea, and China. The FDA is also reviewing a prefilled syringe for gMG and CIDP, with a submission expected in the second quarter of 2024.

Argenx is advancing a diverse pipeline, with plans to conduct registrational trials for multiple programs, including empasiprubart in multifocal motor neuropathy (MMN) and efgartigimod in Sjogren's disease. The company is dedicated to understanding the FcRn mechanism further, with Phase 2 data points expected this year. Argenx aims to bring new molecules to the clinic rapidly, building on their promise of innovation.

The pipeline also includes empasiprubart, with Phase 2 studies in progress for MMN, delayed graft function (DGF), and dermatomyositis (DM). Additionally, argenx is developing ARGX-119, a muscle-specific kinase (MuSK) agonist, for congenital myasthenic syndrome (CMS) and amyotrophic lateral sclerosis (ALS).

Financially, argenx reported total operating income of $413 million for the first quarter of 2024, a significant increase from $230 million in the same period in 2023. This includes product net sales of $398 million, collaboration revenue of $3 million, and other operating income of $12 million. However, total operating expenses rose to $506 million from $334 million, primarily due to increased costs of sales, research and development expenses, and selling, general, and administrative expenses.

The company reported a net loss of $62 million for the first quarter of 2024, compared to a $29 million loss in the same period the previous year. On a per-share basis, the net loss was $1.04, up from $0.52 in the first quarter of 2023. Cash, cash equivalents, and current financial assets totaled $3.1 billion as of March 31, 2024.

Going forward in 2024, argenx expects its combined research and development and selling, general, and administrative expenses to be under $2 billion. The company anticipates using up to $500 million in net cash for these expenses, working capital, and capital expenditures.

Argenx has scheduled its financial updates for the rest of the year, with quarterly results and business updates to be announced on July 25 and October 31, 2024.