argenx (NASDAQ:ARGX) used its fourth-quarter earnings call to highlight positive Phase 3 data in ocular myasthenia gravis (MG), continued commercial momentum for VYVGART, and its first year of annual operating profitability.
Phase 3 ADAPT OCULUS hit primary endpoint in ocular MG
Chief Medical Officer Luc Truyen said the company’s Phase 3 ADAPT OCULUS trial was designed as the first registrational study in ocular MG, enrolling patients with MGFA Class I disease who had meaningful, measurable eye symptoms without evidence of generalized MG and who were on stable background therapy.
Truyen said the study met its primary endpoint, with VYVGART high-titer producing a statistically significant improvement versus placebo at Week 4 (p=0.012). Patients treated with VYVGART had a mean 4.04-point improvement versus a 1.99-point improvement on placebo, with “clear improvements” in diplopia and ptosis. He added that VYVGART was well-tolerated and showed no new safety signals, consistent with its established safety profile. The company said it plans to present broader data at an upcoming medical meeting and intends to file a supplemental BLA (sBLA) with the FDA based on the results.
Management outlined MG label expansion plans and timelines
Chief Operating Officer Karen Massey said the company views the ADAPT OCULUS results as a “meaningful opportunity” to broaden VYVGART’s reach in MG alongside progress in seronegative MG. She reiterated that the seronegative MG PDUFA date is May 10 and said the company sees “a clear path” to expanding the label into ocular MG as well, with the goal of achieving what she described as the broadest MG label.
In Q&A, Massey referenced prior company estimates that seronegative MG could expand the addressable population by about 11,000 patients and ocular MG by about 7,000 patients, noting the ocular figure represented those believed eligible for VYVGART based on market research rather than the entire ocular MG population.
Executives also addressed the possibility that treating ocular MG earlier could delay progression to generalized disease. Truyen said the company plans to collect long-term data, noting that epidemiological data suggest a high percentage of ocular MG patients progress to generalized MG. He said the open-label extension is expected to provide more than two years of follow-up, but cautioned that the dataset would be non-controlled, meaning any claim about delaying progression may need to come through publication, real-world evidence, or further regulatory discussions.
VYVGART commercial update: patient growth, PFS uptake, and CIDP access
Massey said 2025 was a strong year of execution, with approximately 19,000 patients globally. She attributed part of the growth to the successful launch of a prefilled syringe (PFS) for self-injection, and she said VYVGART is “leading the growth of biologics” in both MG and CIDP.
Chief Commercialization Officer Sandrine Piret-Gerard, who said she joined the company recently, reported that the company ended the fourth quarter with more than 4,700 prescribers, including about 1,000 new prescribers since the PFS launch. She described VYVGART as the “fastest-growing and number one prescribed biologics in MG,” stating that six out of ten MG patients starting a biologic begin with VYVGART and that 70% of VYVGART patients are coming from oral therapies.
In CIDP, Piret-Gerard said the company remains early in its launch trajectory and is focused on evidence generation, patient activation, and prescriber adoption. She noted that the PFS reduces administration burden and said the company secured a UnitedHealthcare coverage expansion in the fourth quarter, bringing covered lives for PFS to more than 90%. Massey added that about 85% of CIDP patients using VYVGART are still switching from IVIG, though the company is starting to see some use beyond that switch population as experience grows.
Executives also said they anticipate typical first-quarter “seasonal dynamics” such as reverifications and winter storms, pointing to a similar pattern seen previously.
Pricing and payer expectations for new MG sub-indications
During Q&A, CFO Karl Gubitz said argenx expects broad access for seronegative and ocular MG, while noting that payer discussions still need to occur. He said the company assumes “a similar price as MG,” and cited $225,000 as the net price to argenx.
On timing, Massey said the company expects it typically takes about two quarters after approval to update payer policies and contracts before seeing a meaningful commercial contribution from a new label expansion, though the first step is filing “as soon as we can” based on the ocular data.
Financial results: $4.2B full-year net sales and first annual operating profit
Gubitz said product net sales were consistent with the company’s January pre-announcement: $1.3 billion in the fourth quarter and $4.2 billion for full-year 2025, representing 90% year-over-year growth. Fourth-quarter regional product revenue included $1.1 billion in the U.S., $63 million in Japan, $110 million in the rest of the world, and $26 million in products supplied to Zai Lab in China. He said U.S. product net sales grew 68% year-over-year in the quarter, with gross-to-net adjustments and net pricing in line with the prior quarter.
Total fourth-quarter operating expenses were $955 million, up $149 million from the third quarter. Cost of sales was $150 million, and Gubitz said the year-to-date gross margin was consistent at 11%. Combined R&D and SG&A expenses totaled $2.7 billion for the full year, which he said was in line with prior guidance.
argenx reported operating profit of $367 million in the fourth quarter and $1.1 billion for the full year, marking its first year of annual operating profitability. Gubitz said tax reflected a net benefit due largely to non-recurring items and favorable foreign exchange movements, and he guided to an effective tax rate in the low-to-mid teens going forward. Profit was $533 million for the quarter and $1.3 billion for the year. Cash, cash equivalents, and current financial assets were $4.4 billion at quarter-end, up more than $1 billion over the year.
Looking to 2026, Gubitz said operating expenses are expected to continue growing at a similar percentage rate as in prior years, with much of the growth in R&D. He also said the company expects revenue growth to exceed operating expense growth over time, supporting expanding operating margins.
About argenex (NASDAQ:ARGX)
argenx (NASDAQ: ARGX) is a biotechnology company focused on the discovery, development and commercialization of antibody-based therapeutics for severe autoimmune and neuromuscular diseases. The company uses its proprietary SIMPLE Antibody platform to generate differentiated antibodies and engineered Fc regions, and it pursues mechanisms that modulate the neonatal Fc receptor (FcRn) to reduce pathogenic IgG levels. Argenx’s research and development activities span target identification, preclinical development and late-stage clinical programs aimed at addressing unmet needs in immunology.
The company’s lead product, efgartigimod (marketed as Vyvgart), is an FcRn antagonist developed to reduce circulating IgG antibodies and treat IgG-mediated disorders.
