On October 22, 2026 argenx SE (Euronext & Nasdaq: ARGX), the immunology innovation company, reported its third quarter 2026 results and provided a business update.

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"The story of argenx is one of continued innovation, growth and impact," said Karen Massey, Chief Executive Officer. "VYVGART is the foundation of our business and continues to deliver strong performance across gMG and CIDP, with significant opportunity still ahead as we reach more patients, expand into new indications, and advance the next wave of FcRn medicines. The positive results from our Phase 3 ALKIVIA study further reinforce the potential of VYVGART beyond neurology, and underscore how much more it can deliver for patients. The upcoming Phase 3 readout for empasiprubart in MMN, the advancement of FB102, and progress across our emerging immunology pipeline are bringing the next chapter of argenx into focus as we build a global immunology innovator positioned for durable growth and value creation well beyond Vision 2030."

Vision 2030

argenx remains on track to achieve its ‘Vision 2030’ anchored in the ambition to treat 50,000 patients globally with its medicines, secure 10 labeled indications, and progress five pipeline candidates into registrational development by 2030.

Realizing the full potential of VYVGART and advancing FcRn leadership

VYVGART (IV: efgartigimod alfa-fcab; SC: efgartigimod alfa and hyaluronidase-qvfc) is the first-and-only approved treatment for all adult patients living with generalized myasthenia gravis (gMG). It is also approved for chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and primary immune thrombocytopenia (ITP) in Japan. Building on VYVGART’s leadership in MG and CIDP, argenx is progressing multiple label and indication expansions, exploring VYVGART’s potential in additional autoimmune diseases through proof-of-concept studies, and advancing next-generation FcRn molecules and delivery modalities.
•Generated $1.7 billion in global product net sales in the third quarter of 2026, representing 54% year-over-year growth and 13% quarter-over-quarter growth
•Submitted a Supplemental Biologics License Application (sBLA) for VYVGART in ocular myasthenia gravis (oMG) to the U.S. Food and Drug Administration (FDA)
•sBLA for VYVGART and VYVGART Hytrulo in pediatric gMG accepted for priority review by the FDA, with a PDUFA target action date in February 2027
•VYVGART Hytrulo autoinjector expected to launch in second half of 2027 for all approved indications
•Reported positive Phase 3 ALKIVIA results with consistent and clinically meaningful treatment effects observed across immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM); sBLA for VYVGART Hytrulo in IMNM on track for submission by year-end 2026, supported by Breakthrough Therapy Designation, with plans to conduct an additional registrational study in DM.
•Topline results from Phase 3 ADVANCE-NEXT study in primary ITP expected in first half of 2027
•Phase 3 VitaliThy studies in Graves’ disease ongoing;
•Advancing the future FcRn portfolio, including Phase 3-ready ARGX-213, designed for monthly dosing, and ARGX-124 currently in Phase 1 development

Advancing empasiprubart, argenx’s second pipeline-in-a-product opportunity

Empasiprubart (anti-C2) is argenx’s second pipeline-in-a-product opportunity and is being evaluated in Phase 3 studies in multifocal motor neuropathy (MMN) and CIDP, with additional Phase 2 studies exploring its potential in other indications and in combination with VYVGART in gMG.

•Topline results from the Phase 3 EMPASSION study (MMN) expected in December 2026
•Topline results from Phase 3 EMVIGORATE and EMNERGIZE studies in CIDP anticipated in the second half of 2027
•Phase 2 ADAPT-Forward platform study in gMG ongoing, evaluating empasiprubart as an add-on to efgartigimod and as monotherapy to support combination development pathway

Delivering next wave of immunology innovation

Beyond the FcRn portfolio and empasiprubart, argenx is advancing a differentiated immunology pipeline that includes FB102 (CD122), adimanebart (MuSK), ARGX-121 (IgA), ARGX-109 (IL-6), TSP-101 (Fn14), ARGX-118 (Galectin-10) and ARGX-125 (undisclosed target), together with additional candidates emerging from the Immunology Innovation Program. These programs support argenx’s ambition to build multiple pillars of sustainable growth beyond Vision 2030.

•Advancing FB102 to Phase 3 in celiac disease based on positive Phase 2 results, with ongoing programs in alopecia areata and vitiligo and potential across other autoimmune diseases
•Phase 3 study of adimanebart in congenital myasthenic syndromes (CMS) expected to begin in 2026; Phase 2 in spinal muscular atrophy (SMA) ongoing
•Phase 2 study of ARGX-121 in IgA nephropathy (IgAN) ongoing
•Advancing Phase 1 development of TSP-101, ARGX-118 and ARGX-125

THIRD QUARTER 2026 FINANCIAL RESULTS
argenx SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS
Three Months Ended Nine Months Ended
September 30, September 30,
(in millions of $ except for per share data) 2026 2025 2026 2025
Product net sales $ 1,721 $ 1,127 $ 4,534 $ 2,866
Other operating income 30 24 71 60
Total operating income $ 1,751 $ 1,151 $ 4,605 $ 2,926
Cost of sales $ (165) $ (109) $ (431) $ (301)
Research and development expenses* (503) (359) (1,432) (1,001)
Selling, general and administrative expenses (598) (336) (1,370) (937)
Total operating expenses $ (1,266) $ (805) $ (3,233) $ (2,240)
Operating profit $ 486 $ 346 $ 1,372 $ 686
Financial income $ 45 $ 43 $ 137 $ 118
Financial expense (1) (1) (3) (3)
Exchange gains/(losses) 8 (2) (11) 74
Profit for the period before taxes $ 538 $ 386 $ 1,495 $ 875
Income tax expense $ (32) $ (42) $ (151) $ (116)
Profit for the period $ 506 $ 344 $ 1,344 $ 759
Profit for the period attributable to:
Owners of the parent $ 506 $ 344 $ 1,344 $ 759
Weighted average number of shares used for basic profit per share 62,735,385 61,371,508 62,370,746 61,147,873
Basic profit per share (in $) 8.07 5.61 21.54 12.41
Weighted average number of shares used for diluted profit per share 64,886,406 66,441,326 64,578,235 65,944,952
Diluted profit per share (in $) 7.80 5.18 20.81 11.51

DETAILS OF THE FINANCIAL RESULTS
Total operating income for the three and nine months ended September 30, 2026 was $1.8 billion and $4.6 billion, respectively, compared to $1.2 billion and $2.9 billion, respectively, for the same periods in 2025, and mainly consisted of:
•Product net sales of VYVGART for the three and nine months ended September 30, 2026, were $1.7 billion and $4.5 billion, respectively, compared to $1.1 billion and $2.9 billion, respectively, for the same periods in 2025.

•Other operating income for the three and nine months ended September 30, 2026 was $30 million and $71 million, respectively, compared to $24 million and $60 million, respectively, for the same periods in 2025. The other operating income in these periods primarily related to research and development tax incentives and payroll tax rebates.
Total operating expenses for the three and nine months ended September 30, 2026 were $1.3 billion and $3.2 billion, respectively, compared to $0.8 billion and $2.2 billion, respectively, for the same periods in 2025, and mainly consisted of:
•Cost of sales for the three and nine months ended September 30, 2026 was $165 million and $431 million, respectively, compared to $109 million and $301 million, respectively, for the same periods in 2025. The cost of sales was related to the sale of VYVGART.

•Research and development expenses for the three and nine months ended September 30, 2026 were $0.5 billion and $1.4 billion, respectively, compared to $0.4 billion and $1.0 billion, respectively, for the same periods in 2025. The research and development expenses mainly related to advancing efgartigimod, empasiprubart, adimanebart and FB102 across multiple registrational studies, plus early-stage pipeline and preclinical programs.
•Selling, general and administrative expenses for the three and nine months ended September 30, 2026 were $0.6 billion and $1.4 billion, respectively, compared to $0.3 billion and $0.9 billion, respectively, for the same periods in 2025. The selling, general and administrative expenses mainly related to professional and marketing fees linked to the global commercialization of the VYVGART franchise, and personnel expenses. Selling, general and administrative expenses for the three- and nine-month periods ended September 30, 2026 included approximately $150 million of acquisition-related expenses associated with the Company’s acquisition of Forte Biosciences Inc.
Financial income for the three and nine months ended September 30, 2026 was $45 million and $137 million, respectively, compared to $43 million and $118 million, respectively, for the same periods in 2025.
Exchange gains/losses for the three and nine months ended September 30, 2026 were an $8 million gain and an $11 million loss, respectively, compared to a $2 million loss and a $74 million gain, respectively, for the same periods in 2025.
Income tax for the three- and nine-month periods ended September 30, 2026 and 2025 is detailed below:
Three Months Ended
Nine Months Ended
September 30, September 30,
(in millions of $) 2026 2025 2026 2025
Current tax expense
$ (129) $ (52) $ (359) $ (122)
Deferred tax benefit
97 10 208 6
Income tax expense $ (32) $ (42) $ (151) $ (116)

Profit for the three- and nine-month periods ended September 30, 2026 was $0.5 billion and $1.3 billion, respectively, compared to $0.3 billion and $0.8 billion, respectively, for the same periods in 2025. The basic profit per share was $8.07 for the three months ended September 30, 2026, compared to $5.61 for the same period in 2025. The basic profit per share was $21.54 for the nine months ended September 30, 2026, compared to $12.41 for the same period in 2025.

Cash, cash equivalents and current financial assets1 consisted of $2.6 billion in cash and cash equivalents and $1.1 billion in current financial assets which totaled $3.7 billion as of September 30, 2026 after paying approximately $2.1 billion for the acquisition of Forte Biosciences Inc., net of acquired cash, compared to $3.5 billion in cash and cash equivalents and $0.9 billion in current financial assets which totaled $4.4 billion as of December 31, 2025.

FULL YEAR EXPECTATIONS

Combined R&D and SG&A expenses are now expected to be approximately $4 billion for 2026, including the Forte transaction-related costs.

EXPECTED FINANCIAL CALENDAR
•February 25, 2027: Full-year 2026 Financial Results and Fourth Quarter 2026 Business Update
•April 29, 2027: First Quarter 2027 Financial Results and Business Update
•July 22, 2027: Half Year and Second Quarter 2027 Financial Results and Business Update
•October 21, 2027: Third Quarter 2027 Financial Results and Business Update

CONFERENCE CALL DETAILS
The third quarter 2026 financial results and business update will be discussed during a conference call and webcast presentation today at 2:30 PM CET/8:30 AM ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors.

Participants can access the conference call by dialing 800-590-8290 (United States and Canada) or 240-690-8800 (International). Country specific dial-in numbers are listed below:
Belgium 32 2290 4635
France 33 172 001717
Netherlands 31 20 795 2683
United Kingdom 44 203 393 1560
Japan 81 3 4520 9761
Switzerland 41 43 210 51 68

Use the access code 3810049 to join the call. Please dial in 15 minutes prior to the live call.

A replay of the webcast will be available on the argenx website.

(Press release, argenx, OCT 22, 2026, View Source [SID1234673666])