argenx, a global leader in immunology dedicated to enhancing the lives of individuals grappling with severe autoimmune disorders, has unveiled its financial results for the first quarter of 2024 along with a comprehensive business update.
Tim Van Hauwermeiren, Chief Executive Officer of argenx, expressed, “The team at argenx has made significant progress executing across the ambitious plan we set out at the beginning of the year. We are driven by our commitment to provide patients with the broadest gMG product offering that consistently delivers on safety and efficacy. VYVGART SC played a key role in our growth over the quarter, expanding the breadth of our prescriber base and reaching new patients.”
Key Highlights from Q1 2024 and Recent Business Updates:
Expanding Reach with VYVGART:
- VYVGART, a first-in-class antibody fragment targeting the neonatal Fc receptor (FcRn), has gained approval in over 30 countries globally for the treatment of generalized myasthenia gravis (gMG) and in Japan for primary immune thrombocytopenia (ITP).
- Global net product sales, inclusive of both VYVGART and VYVGART SC, amounted to $398 million in Q1 2024.
- VYVGART has secured approval in Japan for the treatment of ITP, marking its first global approval for this indication.
- Multiple regulatory decisions regarding VYVGART and VYVGART SC are anticipated in 2024, including approvals for gMG in various countries.
- Regulatory submissions for VYVGART SC for chronic inflammatory demyelinating polyneuropathy (CIDP) are underway or planned in multiple regions.
- Further development of VYVGART SC prefilled syringe for gMG and CIDP is progressing positively, with an FDA submission expected in Q2 2024.
Advancements in Pipeline:
- argenx is making significant strides in advancing its immunology pipeline, with several pipeline-in-a-product candidates progressing.
- Decision announced to advance efgartigimod in primary Sjogren’s disease (SjD) to Phase 3 following analysis of Phase 2 RHO study data.
- Topline data from Phase 2 ALPHA study of efgartigimod in post-COVID-19 postural orthostatic tachycardia syndrome (PC-POTS) is expected in Q2 2024.
- Full Phase 2 topline data from ARDA study of empasiprubart in multifocal motor neuropathy (MMN) is anticipated in 2024.
- Phase 1b/2a trials of ARGX-119 to assess early signal detection in patients with congenital myasthenic syndrome (CMS) and amyotrophic lateral sclerosis (ALS) are expected to commence in 2024.
Drive for Long-Term Pipeline Growth:
- argenx continues to invest in its discovery engine, the Immunology Innovation Program (IIP), to drive sustainable pipeline growth.
- Four new pipeline candidates have been nominated through the IIP, further bolstering argenx’s commitment to innovation in immunology.
Financial Highlights for Q1 2024:
- Total operating income for Q1 2024 amounted to $413 million, reflecting significant growth compared to the same period in 2023.
- Product net sales, collaboration revenue, and other operating income contributed to this increase.
- Total operating expenses for Q1 2024 were $506 million, primarily driven by cost of sales, research and development expenses, and selling, general, and administrative expenses.
- Despite increased operating expenses, argenx remains committed to managing costs efficiently, with combined Research and development and Selling, general and administrative expenses expected to be less than $2 billion for the full year 2024.
Looking Ahead:
- The company anticipates continued growth and progress across its pipeline and commercialization efforts.
- A conference call and webcast presentation discussing the first quarter 2024 financial results and business update will be held today at 2:30 PM CET/8:30 AM ET.
- Interested parties can access the webcast on the Investors section of the argenx website, with dial-in numbers provided for participation.
