On July 30, 2025 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported its half year 2025 results and provided a second quarter business update (Press release, argenx, JUL 31, 2025, View Source [SID1234654645]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to make meaningful progress towards our Vision 2030, advancing bold innovation that has already reached more than 15,000 patients globally" said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "VYVGART is delivering strong growth across all indications, formulations and regions. We are still in the early stages of capturing the full market opportunity in MG and CIDP, with the recent launch of the VYVGART SC prefilled syringe driving demand from new patients and prescribers. In MG, we are shaping the market as the fastest growing biologic, moving earlier in the patient treatment paradigm, and working toward the broadest possible label. In CIDP, we continue to see consistent patient growth, with ample runway to reach the 12,000 patients in the U.S. who remain inadequately controlled on standard of care. This is just the beginning of the larger growth opportunity ahead. With six registrational and six proof-of-concept readouts expected by the end of 2026, we are executing on our proven innovation playbook that is delivering pipeline-in-a-product opportunities aimed at transforming care for patients with high unmet need."

Advancing Towards Vision 2030

argenx has established its strategic priorities to advance Vision 2030, aiming to treat 50,000 patients globally with its medicines, secure 10 labeled indications across all approved medicines, and advance five pipeline candidates into Phase 3 development by 2030.

Expand global VYVGART opportunity and launch VYVGART SC as prefilled syringe

VYVGART (IV: efgartigimod alfa-fcab and SC: efgartigimod alfa and hyaluronidase-qvfc) is a first-and-only IgG Fc-antibody fragment that targets the neonatal Fc receptor (FcRn). It is approved in three indications, including generalized myasthenia gravis (gMG) globally, primary immune thrombocytopenia (ITP) in Japan, and chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S., Japan, China, and the EU. The VYVGART-SC prefilled syringe (PFS) is now approved for use in the U.S. and EU.

Generated global product net sales (inclusive of both VYVGART and VYVGART SC) of $949 million in the second quarter of 2025
Strong underlying fundamentals across key patient and prescriber metrics with 97% operational growth in product net sales year-over-year from second quarter 2024, and 19% from the first quarter of 2025
First patient dosed in Germany following European Commission (EC) approval for VYVGART-SC (vial and PFS) for CIDP
PFS decision on approval for gMG and CIDP expected in Japan and Canada by end of year
Evidence generation through label-enabling studies:

Topline results expected in second half of 2025 for seronegative gMG (ADAPT-SERON) and first half of 2026 for ocular MG (ADAPT OCULUS)

Topline results expected in second half of 2026 to support FDA submission of VYVGART IV for primary ITP (ADVANCE-NEXT)
Execute 10 registrational and 10 proof-of-concept studies across efgartigimod, empasiprubart and ARGX-119 to advance the next wave of launches

argenx continues to demonstrate breadth and depth within its immunology pipeline, advancing multiple first-in-class product candidates with potential across high-need indications.

Efgartigimod Development

Efgartigimod is being studied across 15 severe autoimmune diseases, highlighting the broad potential of FcRn biology in neurology, rheumatology, and beyond.

Registrational studies are currently ongoing in idiopathic inflammatory myopathies (IIM or myositis), thyroid eye disease (TED), and Sjögren’s disease
Topline results from ALKIVIA study evaluating three myositis subsets (immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS) and dermatomyositis (DM)) expected in second half of 2026
Topline results from two registrational UplighTED studies (TED) expected in second half of 2026
Topline results from registrational UNITY study (Sjögren’s disease) expected in 2027
Proof-of-concept studies ongoing in lupus nephritis (LN), systemic sclerosis (SSc) and antibody mediated rejection (AMR); topline results expected for LN in fourth quarter of 2025, SSc in second half of 2026, and AMR in 2027

Empasiprubart Development

Empasiprubart, a first-in-class, humanized, monoclonal antibody that specifically binds to C2, is currently being evaluated in four indications. These include registrational studies in multifocal motor neuropathy (MMN) and CIDP, and proof-of-concept studies in delayed graft function (DGF) and DM.

Topline results from registrational EMPASSION study (MMN) evaluating empasiprubart head-to-head versus IVIg expected in second half of 2026
Registrational EMVIGORATE study ongoing in CIDP evaluating empasiprubart head-to-head versus IVIg
Topline results expected for DGF in the second half of 2025 and for DM in first half of 2026

ARGX-119 Development

ARGX-119, a first-in-class agonist antibody that targets muscle-specific kinase (MuSK), is being evaluated in congenital myasthenic syndromes (CMS), amyotrophic lateral sclerosis (ALS), and spinal muscular atrophy (SMA).

Registrational study to start in CMS in 2026 following positive Phase 1b proof-of-concept data
Phase 2a proof-of-concept study ongoing in ALS; topline results expected in first half of 2026
SMA proof-of-concept study on track to start by end of year
ARGX-119 R&D webinar to be hosted on September 16, 2025
Advance four new pipeline molecules and generate sustainable value through continued investment in Immunology Innovation Program

argenx continues to invest in its Immunology Innovation Program (IIP) to drive long-term sustainable pipeline growth. Through the IIP, four new pipeline candidates have been nominated, including: ARGX-213, targeting FcRn and further solidifying argenx’s leadership in this biology; ARGX-121, a first-in-class molecule targeting IgA; ARGX-109, targeting IL-6, which plays an important role in inflammation, and a fourth pipeline candidate, a first-in-class sweeping antibody for which the target has not yet been disclosed.

Phase 1 results from ongoing ARGX-109 study expected in second half of 2025, and from ongoing ARGX-213 and ARGX-121 studies expected in first half of 2026
Entered strategic collaboration with Unnatural Products (UNP) to expand argenx discovery capabilities into the oral peptide space. This partnership reinforces argenx’s commitment to enhance the patient experience and advance its pipeline of precision therapies.

SECOND QUARTER 2025 FINANCIAL RESULTS
argenx SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS

Three Months Ended Six Months Ended
30 June, 30 June,
(in thousands of $ except per share data) 2025 2024 2025 2024
Product net sales $ 948,594 $ 477,635 $ 1,738,644 $ 875,918
Other operating income* 18,593 11,793 35,913 26,023
Total operating income $ 967,187 $ 489,428 $ 1,774,557 $ 901,941

Cost of sales $ (110,747) $ (52,383) $ (191,552) $ (95,561)
Research and development expenses (327,697) (225,286) (636,767) (450,255)
Selling, general and administrative expenses (324,902) (255,699) (601,150) (491,694)
Loss from investment in a joint venture (2,780) (1,521) (5,087) (3,313)
Total operating expenses $ (766,126) $ (534,889) $ (1,434,556) $ (1,040,823)

Operating profit/(loss) $ 201,061 $ (45,461) $ 340,001 $ (138,882)

Financial income $ 38,399 $ 38,933 $ 75,517 $ 77,828
Financial expense (1,126) (572) (2,261) (1,084)
Exchange gains/(losses) 48,565 (7,903) 76,003 (27,215)

Profit/(Loss) for the period before taxes $ 286,899 $ (15,003) $ 489,260 $ (89,353)
Income tax (expense)/benefit $ (41,541) $ 44,069 $ (74,433) $ 56,822
Profit/(Loss) for the period $ 245,358 $ 29,066 $ 414,827 $ (32,531)
Profit/(Loss) for the period attributable to:
Owners of the parent $ 245,358 $ 29,066 $ 414,827 $ (32,531)
Weighted average number of shares used for basic profit/(loss) per share 61,084,250 59,490,437 61,034,202 59,400,217
Basic profit/(loss) per share (in $) 4.02 0.49 6.80 (0.55)
Weighted average number of shares used for diluted profit/(loss) per share 65,639,446 63,893,007 65,653,007 59,400,217
Diluted profit/(loss) per share (in $) 3.74 0.45 6.32 (0.55)
*Comparative figures have been presented to be consistent with the one adopted in the current period with respect to the combination of collaboration revenue and other operating income.

DETAILS OF THE FINANCIAL RESULTS

Total operating income for the three and six months ended June 30, 2025, was $967 million and $1,775 million, respectively, compared to $489 million and $902 million, respectively, for the same periods in 2024, and mainly consists of:

Product net sales of VYVGART and VYVGART SC for the three and six months ended June 30, 2025, were $949 million and $1,739 million, respectively, compared to $478 million and $876 million, respectively, for the same periods in 2024.

Other operating income for the three and six months ended June 30, 2025, was $19 million and $36 million, respectively, compared to $12 million and $26 million, respectively, for the same periods in 2024. The other operating income for the three and six months ended June 30, 2025 and 2024, primarily relates to research and development tax incentives and payroll tax rebates.

Total operating expenses for the three and six months ended June 30, 2025 were $766 million and $1,435 million, respectively, compared to $535 million and $1,041 million, respectively, for the same periods in 2024, and mainly consist of:

Cost of sales for the three and six months ended June 30, 2025, was $111 million and $192 million, respectively, compared to $52 million and $96 million for the same periods in 2024, respectively. The cost of sales was related to the sale of VYVGART and VYVGART SC.
Research and development expenses for the three and six months ended June 30, 2025, were $328 million and $637 million, respectively, compared to $225 million and $450 million, respectively, for the same periods in 2024. The research and development expenses mainly relate to:
the clinical development and expansion of efgartigimod in 15 severe autoimmune diseases;
the ramp-up of studies for the development of empasiprubart into MMN, DGF, DM and CIDP;
the investments for ARGX-119 in proof-of-concept studies ongoing in ALS, CMS and SMA; and
other discovery and preclinical pipeline candidates.
Selling, general and administrative expenses for the three and six months ended June 30, 2025, were $325 million and $601 million, respectively, compared to $256 million and $492 million, respectively, for the same periods in 2024. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the global commercialization of VYVGART franchise, and personnel expenses.

Financial income for the three and six months ended June 30, 2025, was $38 million and $76 million, respectively, compared to $39 million and $78 million, respectively, for the same periods in 2024.

Exchange gains for the three and six months ended June 30, 2025, were $49 million and $76 million, respectively, compared to $8 million and $27 million, respectively, of exchange losses for the same periods in 2024. Exchange gains/losses are mainly attributable to unrealized exchange rate gains or losses on the cash, cash equivalents and current financial assets denominated in Euro.

Income tax for the three and six months ended June 30, 2025 and 2024 is detailed below:

Three Months Ended Six Months Ended
30 June, 30 June,
(in millions of $) 2025 2024 2025 2024
Current tax (expense)/benefit $ (41) $ (9) $ (70) $ (16)
Deferred tax (expense)/benefit (1) 53 (4) 72
Income tax (expense)/benefit $ (42) $ 44 $ (74) $ 57
Profit for the three- and six-month periods ended June 30, 2025, was $245 million and $415 million, respectively, compared to a profit of $29 million and a loss of $33 million, respectively, for the same periods in 2024. The basic profit per share was $4.02 for the three months ended June 30, 2025, compared to a basic profit per share of $0.49 for the same period in 2024. The basic profit per share was $6.80 for the six months ended June 30, 2025, compared to a basic loss per share of $0.55 for the same period in 2024.

Cash flow from operating activities for the six months ended June 30, 2025 was $362 million compared to a cash flow used in operating activities for the same period in 2024 of $126 million.

FINANCIAL GUIDANCE

The financial guidance on the combined research and development and selling, general and administrative remains unchanged at approximately $2.5 billion.

EXPECTED 2025 FINANCIAL CALENDAR

October 30, 2025: Third Quarter 2025 Financial Results and Business Update
February 26, 2025: Full-year 2025 Financial Results and Fourth Quarter 2025 Business Update

CONFERENCE CALL DETAILS

The half-year 2025 financial results and second quarter 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. A replay of the webcast will be available on the argenx website.