argenx Announces H1 2024 Financials and Q2 Business Update

Argenx SE, a global immunology enterprise headquartered in Amsterdam, released its half-year 2024 results and provided insights on its second-quarter performance, reflecting the company's commitment to addressing severe autoimmune diseases. The first half of 2024 saw significant advances, especially with the recent launch of VYVGART Hytrulo, marking the treatment of the first CIDP patients following the FDA's approval on June 21, 2024.

In Q2 2024, argenx achieved $478 million in global net product sales. This impressive figure underscores the successful commercial execution and expansion of patient reach, particularly in the treatment of generalized myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP). CEO Tim Van Hauwermeiren emphasized the company's strategic vision, "Vision 2030," which aims to sustain innovation and patient care in autoimmune disease treatment.

The company’s "Vision 2030" initiative, revealed during the R&D Day on July 16, 2024, outlines ambitious goals such as having 50,000 patients on argenx medications globally, achieving 10 labeled indications across approved assets, and advancing five new molecules to Phase 3 development. This roadmap focuses on strengthening argenx's leadership in neonatal Fc receptor (FcRn) biology and ensuring sustainable growth by scaling its development pipeline.

VYVGART, a flagship product of argenx, has been a key driver of this growth. Approved for both intravenous (IV) and subcutaneous (SC) injections, VYVGART treats generalized myasthenia gravis (gMG) worldwide, primary immune thrombocytopenia (ITP) in Japan, and CIDP in the United States. The second quarter saw substantial sales from VYVGART and its SC variant, coupled with significant regulatory milestones including the approval of VYVGART SC for gMG in China by the National Medical Products Administration (NMPA).

The business update highlighted multiple regulatory submissions and anticipated decisions for VYVGART. VYVGART is under review or planned for submission in several regions for CIDP, including China, Japan, Europe, and Canada. Additionally, plans for a registrational study evaluating VYVGART in ocular MG are set to launch by the end of the year, further supporting potential label expansions for broader MG populations.

Argenx's robust pipeline reflects its extensive work in immunology. Currently, efgartigimod, the active molecule in VYVGART, is under development for 15 different indications, including thyroid eye disease (TED) and primary Sjogren’s disease (SjD). The company also highlighted advancements in its first-in-class C2 inhibitor, empasiprubart, intended for conditions like multifocal motor neuropathy (MMN), delayed graft function (DGF), dermatomyositis (DM), and CIDP.

The financial results for the second quarter of 2024 show strong performance with a total operating income of $489 million, up from $281 million in the previous year. The increase is attributed mainly to higher product net sales and other operating incomes such as research and development tax incentives. However, the company also reported higher operating expenses totaling $535 million, driven by increased costs associated with sales, research and development, and administrative activities.

Argenx continues to invest significantly in its Immunology Innovation Program (IIP), which has resulted in the nomination of four new pipeline candidates. The company expects to begin Phase 1 studies for ARGX-213 and ARGX-121 by the second half of 2025, with investigational new drug applications for ARGX-220 and ARGX-109 anticipated by the end of 2025.

Despite these advancements, argenx reported a net loss for the first half of 2024, amounting to $33 million compared to a $123 million loss in the same period in 2023. The company’s financial forecast for 2024 suggests combined research and development and administrative expenses will be under $2 billion, with a cash burn of less than $500 million for the year.

Argenx's strategic vision and robust pipeline underscore its potential for long-term growth and continued leadership in autoimmune disease treatment. The company remains on track to initiate four additional Phase 3 registrational studies across efgartigimod and empasiprubart by the end of 2024.