Detailed narrative
Record quarter — VYVGART surpasses $1B in a single quarter
argenx reported total product net sales of $1.13B, up 19% ($178M) QoQ and 96% ($554M) YoY, marking the first quarter VYVGART sales exceeded $1B. By region, US sales were $964M (+20% QoQ), Japan $60M, rest of world $94M (including partner markets), and $9M of product supply to Zai Lab in China.
Management said gross-to-net adjustments and US net pricing were in line with the prior quarter, and PFS is now firmly established as the growth driver across gMG and CIDP.
Profitability and balance sheet
Total operating expenses were $805M (+5% QoQ), with R&D up 9% ($28M) and SG&A up 4% ($11M). Cost of sales was $109M and YTD effective tax rate 13%. Operating profit was $346M and, with $43M of financial income, profit before tax reached $386M; after-tax profit was $344M for the quarter and $759M YTD.
Cash, equivalents and current financial assets ended at $4.3B, a nearly $1B increase since year-start, giving the company a widening aperture for external innovation and BD.
Commercial engine — PFS pulls VYVGART earlier in the paradigm
VYVGART has now reached more than 15,000 patients globally across 3 indications and 3 presentations since first approval 4 years ago. More than half of PFS starters are new to VYVGART, and over 260 prescribers have written their first-ever VYVGART prescription since the self-injection launch.
In MG — where argenx is the #1 and fastest-growing biologic — the share of patients coming from oral therapies rose YoY to 70%, evidence of earlier adoption toward the stated 60,000-patient opportunity and an incremental 25,000-patient biologics-market expansion. In CIDP, 85% of patients are IVIg switches with naive starts emerging, tracking toward a 12,000 not-well-controlled addressable market.
Pipeline expansion — three Phase III assets and disciplined pruning
argenx enters 2026 with three first-in-class Phase III assets: efgartigimod, empasiprubart (C2 blocker) and ARGX-119 (MuSK agonist, now in Phase III for CMS). Management made three disciplined decisions: stopped empasiprubart in dermatomyositis (enrollment challenges); declined to advance efgartigimod into a registrational lupus nephritis study after Phase II; and added Graves' disease as the next efgartigimod indication, moving directly to Phase III.
Next-generation FcRn assets ARGX-213 (long-acting VHH targeting monthly dosing) and ARGX-121 (IgA sweeper) are progressing through Phase I with data disclosures expected soon.
gMG data leadership at AANEM
New long-term ADAPT subcutaneous data showed up to 60% of patients reaching minimum symptom expression (MSE) with 83-85% maintaining it for at least 8 weeks. Steroid-reduction benefit was sustained through 18 months, with over 55% of patients reducing steroids below 5 mg/day.
ADAPT SERON met its primary endpoint with a clinically meaningful, statistically significant MG-ADL improvement at week 4 versus placebo, with benefit accruing across cycles in all three seronegative subgroups (MuSK+, LRP4+, triple seronegative) — supporting a planned label-expansion filing and reinforcing that pathogenic IgG autoantibodies drive disease regardless of antibody status.
Competitive landscape response
Management addressed J&J's announced Imaavy head-to-head vs VYVGART in gMG, arguing the design (four-dose VYVGART vs continuous dosing, endpoint and readout timing) would mainly reprove a known PD difference and not reflect real-world individualized cyclic dosing. On Novartis' positive Sjogren's data for ianalumab and Roivant's positive brepocitinib Phase III in DM, argenx welcomed competition as market-building while positioning efgartigimod as a precision tool going after circulating immune complexes, cautioning that not all FcRn molecules are equivalent.