UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549


FORM 6-K


REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the Month of July 2024

Commission File Number: 001-38097


ARGENX SE

(Translation of registrant’s name into English)


Laarderhoogtweg 25
1101 EB Amsterdam, the Netherlands

(Address of principal executive offices)


Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F       Form 40-F  

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): 



 

argenx SE

On July 25, 2024, argenx SE (the “Company) issued a press release and unaudited first half-year financial results for 2024, which are further described in an Unaudited Interim Report for the Six Months Ended June 30, 2024, copies of which are attached hereto as Exhibits 99.1 and 99.2, respectively, and are incorporated by reference herein.

The information contained in this Current Report on Form 6-K, including Exhebit 99.1 and Exhebit 99.2, shall be deemed to be incorporated by reference into the Company’s Registration Statements on Forms F-3 (File No. 333-258251 and S-8 (File Nos. 333-225375, 333-258253, and 333-274721), and to be part thereof from the date on which this Current Report on Form 6-K is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

 


EXHIBITS

Exhibit

Description

99.1

Press Release dated July 25, 2024

99.2

Unaudited Interim Report for the Six Months Ended June 30, 2024

101.INS

Inline XBRL Instance Document

101.SCH

Inline XBRL Taxonomy Extension Schema Document

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document

104

Cover Page Interactive Data File (formatted as Inline XBRL)


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

ARGENX SE

Date: July 25, 2024

By:

/s/ Hemamalini (Malini) Moorthy

Hemamalini (Malini) Moorthy

General Counsel


Ex* reflects cash, cash equivalents and current financial assets

hibit 99.1

Graphic

argenx Reports Half Year 2024 Financial Results and Provides Second Quarter Business Update

$478 million in second quarter global net product sales

First CIDP patients treated with VYVGART® Hytrulo following June 21st FDA approval

On track to begin four additional registrational studies across efgartigimod and empasiprubart by end of 2024

Management to host conference call today at 2:30 PM CET (8:30 AM ET)

July 25, 7:00 AM CET

Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced its half year 2024 results and provided a second quarter business update.

“We were excited to unveil our ambition for the future of argenx – Vision 2030 – last week, outlining our plan to develop and deliver continued and sustainable innovation for patients,” said Tim Van Hauwermeiren, Chief Executive Officer, argenx. “We are already delivering on this promise with impressive commercial execution throughout the first half of the year, expanding our patient reach in MG, and launching in CIDP with our broad FDA label. Our development pipeline is stronger than ever, driven by our unique innovation engine. And we are well-positioned to capture the sizeable growth opportunity before us as we seek to reach earlier-line MG patients over the next 12-18 months with potential label expansions and a pre-filled syringe.”

Vision 2030

During its R&D Day on July 16, 2024, argenx unveiled its ‘Vision 2030’ as part of its long-term commitment to transform the treatment of autoimmune diseases by strengthening its leadership in neonatal Fc receptor (FcRn) biology, investing in its continuous pipeline of differentiated antibody candidates, and scaling in a disciplined way to ensure innovation remains core to the argenx mission. ‘Vision 2030’ includes the following goals:

50,000 patients globally on treatment with an argenx medicine
10 labeled indications across all approved assets, including VYVGART franchise and potentially empasiprubart and ARGX-119
Five new molecules in Phase 3 development indicating ongoing investment in internal discovery engine, the Immunology Innovation Program

Reaching 50,000 Patients Globally

VYVGART (efgartigimod alfa-fcab) is a first-in-class antibody fragment targeting FcRn and is now approved for both intravenous use and subcutaneous injection (SC) (efgartigimod alfa and hyaluronidase-qvfc) 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.

Generated global net product sales (inclusive of both VYVGART and VYVGART SC) of $478 million in second quarter of 2024
National Medical Products Administration (NMPA) approved VYVGART SC for treatment of gMG in China through Zai Lab on July 16, 2024
Additional VYVGART regulatory decisions on approval expected for gMG in 2024, including in Switzerland, Australia, and Saudi Arabia
Launched VYVGART Hytrulo in CIDP in U.S. with first patients injected in July

Multiple VYVGART SC regulatory submissions under review or planned for CIDP, including:
oRegulatory submissions completed in China, Japan, and Europe with decisions on approval expected in 2025
oRegulatory submission filing in Canada by end of 2024
Announced plan to evaluate VYVGART in ocular MG with registrational study (ADAPT OCULUS) to start by end of year; OCULUS to support label-expansion strategy into broader MG populations along with ongoing ADAPT SERON study in seronegative MG
Regulatory submission filed and under regulatory review for VYVGART SC pre-filled syringe (PFS) for gMG and and CIDP

Advancing Pipeline to Achieve 10 Labeled Indications by 2030

argenx continues to demonstrate breadth and depth within its immunology pipeline, advancing multiple pipeline-in-a-product candidates. argenx is solidifying its leadership in FcRn biology, with efgartigimod currently in development in 15 indications. argenx is also advancing its first-in-class C2 inhibitor, empasiprubart, which is being evaluated in multifocal motor neuropathy (MMN), delayed graft function (DGF), dermatomyositis (DM), and CIDP. In addition, argenx is evaluating ARGX-119, a muscle-specific kinase (MuSK) agonist in both congenital myasthenic syndrome (CMS) and amyotrophic lateral sclerosis (ALS).

Registrational studies ongoing of efgartigimod in thyroid eye disease (TED)
Advancing development of efgartigimod in primary Sjogren’s disease (SjD) with Phase 3 study to begin by end of 2024
Following alignment meeting with FDA, confirmatory study of VYVGART (IV) in primary ITP to start by end of 2024 to enable registration in U.S.
Topline data from seamless Phase 2/3 ALKIVIA study evaluating efgartigimod across three myositis subsets (immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and DM expected in fourth quarter of 2024
Update on BALLAD study development plan evaluating efgartigimod in bullous pemphigoid (BP) expected by end of 2024
Proof-of-concept studies ongoing with efgartigimod in membranous nephropathy (MN) and lupus nephritis (LN) with studies expected to initiate this year in antibody mediated rejection (AMR) and systemic sclerosis (SSc)
Phase 3 study of empasiprubart for MMN to initiate in fourth quarter of 2024
CIDP nominated as fourth empasiprubart indication, recognizing opportunity to bring multiple innovative treatments to patients
Phase 1b/2a studies of ARGX-119 to assess early signal detection in patients with CMS and ALS to start by end of  2024

Investing in Immunology Innovation Program to Support Five New Molecules in Phase 3 by 2030

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 new class of medicine; ARGX-121, a first-in-class molecule targeting IgA;  ARGX-109, targeting IL-6, which plays an important role in inflammation, and ARGX-220,  a first-in-class sweeping antibody for which the target has not yet been disclosed.

Phase 1 studies of ARGX-213 and ARGX-121 expected to start in second half of 2025
Investigational new drug (IND) applications for ARGX-220 and ARGX-109 on track to be filed by end of 2025


SECOND QUARTER 2024 FINANCIAL RESULTS  

argenx SE

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS

Three Months Ended

Six Months Ended

June 30,

June 30,

(in thousands of $ except for shares and EPS)

2024

2023

2024

2023

Product net sales

 

$

477,635

$

269,313

$

875,918

$

487,335

Collaboration revenue

-

1,237

2,718

2,355

Other operating income

 

11,793

10,485

23,305

21,225

Total operating income

$

489,428

$

281,035

$

901,941

$

510,915

 

 

Cost of sales

$

(52,383)

$

(24,024)

$

(95,561)

$

(42,359)

Research and development expenses

 

(225,286)

(195,509)

(450,255)

(361,364)

Selling, general and administrative expenses

(255,699)

(161,977)

(491,694)

(311,149)

Loss from investment in joint venture

 

(1,521)

(1,619)

(3,313)

(1,880)

Total operating expenses

$

(534,889)

$

(383,129)

$

(1,040,823)

(716,752)

 

 

Operating loss

$

(45,461)

$

(102,094)

$

(138,882)

$

(205,837)

 

 

Financial income

$

38,933

$

20,441

$

77,828

$

37,029

Financial expense

 

(572)

(207)

(1,084)

(395)

Exchange gains/(losses)

(7,903)

(2,001)

(27,215)

9,164

 

 

Loss for the period before taxes

$

(15,003)

$

(83,861)

$

(89,353)

$

(160,039)

Income tax benefit/(expense)

 

$

44,069

$

(10,507)

$

56,822

$

36,800

Profit/(loss) for the period

$

29,066

$

(94,368)

$

(32,531)

$

(123,239)

Profit/(loss) for the period attributable to:

 

Owners of the parent

$

29,066

$

(94,368)

$

(32,531)

$

(123,239)

Weighted average number of shares outstanding

 

59,490,437

55,828,239

59,400,217

55,690,873

Basic profit/(loss) per share (in $)

0.49

(1.69)

(0.55)

(2.21)

Diluted profit/(loss) per share (in $)

 

0.45

(1.69)

(0.55)

(2.21)

Net increase/(decrease) in cash, cash equivalents and current financial assets compared to year-end 2022 and 2023

(77,497)

$

(195,580)

Cash and cash equivalents and current financial assets at the end of the period

 

3,102,347

$

1,996,968

DETAILS OF THE FINANCIAL RESULTS

Total operating income for the three and six months ended June 30, 2024 was $489 million and $902 million compared to $281 million and $511 million for the same periods in 2023, and mainly consists of:

Product net sales of VYVGART and VYVGART SC for the three and six months ended June 30, 2024, were $478 million and $876 million compared to $269 million and $487 million for the same periods in 2023.
Other operating income for the three and six months ended June 30, 2024 was $12 million and $23 million compared to $10 million and $21 million for the same periods in 2023. The other operating income for the three and six months ended June 30, 2024 and 2023, primarily relates to research and development tax incentives.

Total operating expenses for the three and six months ended June 30, 2024 were $535 million and $1,041 million compared to $383 million and $717 million for the same periods in 2023, and mainly consists of:


Cost of sales for the three and six months ended June 30, 2024 was $52 million and $96 million compared to $24 million and $42 million for the same periods in 2023. The cost of sales was recognized with respect to the sale of VYVGART and VYVGART SC.
Research and development expenses for the three and six months ended June 30, 2024 were $225 million and $450 million compared to $196 million and $361 million for the same periods in 2023. The research and development expenses mainly relate to external research and development expenses and personnel expenses incurred in the clinical development of efgartigimod in various indications and the expansion of other clinical and preclinical pipeline candidates.
Selling, general and administrative expenses for the three and six months ended June 30, 2024 were $256 million and $492 million compared to $162 million and $311 million for the same periods in 2023. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the commercialization of VYVGART and VYVGART SC, and personnel expenses.

Financial income for the three and six months ended June 30, 2024, was $39 million and $78 million compared to $20 million and $37 million for the same periods in 2023. The increase in financial income is mainly due to an increase in interest income coming from an increase of cash, cash equivalents and current financial assets as a result of the July 2023 financing round.

Exchange losses for the three and six months ended June 30, 2024, were $8 million and $27 million compared to $2 million exchange losses and $9 million of exchange gains for the same periods in 2023. 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, 2024, was $44 million and $57 million of income tax benefit, respectively, compared to $11 million of income tax expense and $37 million of income tax benefit for the same periods in 2023.

Net Result for the three and six months ended June 30, 2024, was $29 million profit and $33 million loss compared to $94 million and $123 million loss for the same periods in 2023. On a per weighted average share basis, the basic profit was $0.49 and diluted profit was $0.45 for the three months ended June 30, 2024, compared to a basic and diluted loss of $1.69 for the same period in 2023. On a per weighted average share basis, the basic and diluted loss was $0.55 for the six months ended June 30, 2024, compared to a basic and diluted loss of $2.21 for the same period in 2023.

Cash, cash equivalents and current financial assets totalled $3.1 billion as of June 30, 2024, compared to $3.2 billion as of December 31, 2023. The decrease in cash and cash equivalents and current financial assets result from a net cash flows used in operating activities.

FINANCIAL GUIDANCE

Based on its current operating plans, argenx expects its combined research and development and selling, general and administrative expenses in 2024 to be less than $2 billion. argenx updated its cash burn guidance and now expects to utilize less than $500 million of net cash* iin 2024 on anticipated operating expenses as well as working capital and capital expenditures.


EXPECTED 2024 FINANCIAL CALENDAR

October 31, 2024: 3Q 2024 financial results and business update
February 27, 2025: Full-year 2024 financial results and 4Q 2024 business update

CONFERENCE CALL DETAILS

The half-year 2024 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 and replay may be accessed on the Investors section of the argenx website at argenx.com/investors.

Dial-in numbers:

Please dial in 15 minutes prior to the live call.

Belgium32 800 50 201

France33 800 943355

Netherlands31 20 795 1090

United Kingdom44 800 358 0970

United States 1 800 715 9871

Japan81 3 4578 9081

Switzerland41 43 210 11 32

About argenx

argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker, globally in the U.S., Japan, Israel, the EU, the UK, China and Canada. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, X/Twitter, Instagram, Facebook, and YouTube.

For further information, please contact:

Media:

Ben Petok

bpetok@argenx.com

Investors:

Alexandra Roy (US)

aroy@argenx.com

Lynn Elton (EU)

lelton@argenx.com


Forward-looking Statements

The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “advance,” “aim,” “anticipates,” “continue,” “expect,” “expand,” “plan,” or “seek”  and include statements argenx makes regarding its Vision 2030 plan to develop and deliver continued and sustainable innovation for patients; its long-term commitments; its Vision 2030 goals, including having 50,000 patients globally on treatment with an argenx medicine, 10 labeled indications across all approved assets, including VYVGART franchise and potentially empasiprubart and ARGX-119, and five new molecules in Phase 3 development indicating ongoing investment in the immunology innovation program; its growth opportunity; its plans to reach earlier-line MG patients over the next 12-18 months with potential label expansions and a pre-filled syringe; the advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the anticipated timing of four additional Phase 3 registrational studies across efgartigimod and empasiprubart, the expected timing of additional VYVGART regulatory decisions on approval for gMG, including in Switzerland, Australia, and Saudi Arabia, the expected timing of additional VYVGART SC regulatory submissions under review or planned for CIDP, including decisions on approval in China, Japan, and Europe and a regulatory submission filing in Canada, the anticipated timing of the initiation of a Phase 3 study for efgartigimod in primary Sjogren’s disease (SjD), the anticipated timing of a confirmatory study of VYVGART (IV) in primary ITP,  the anticipated timing of topline data from Phase 2/3 ALKIVIA study evaluating efgartigimod across three myositis subsets, the anticipated timing of an update on BALLAD study development plan evaluating efgartigimod in BP, the anticipated timing of proof-of-concept studies for efgartigimod in AMR and SSc, the anticipated timing of the initiation of a Phase 3 study of empasiprubart for MMN, the anticipated timing of the initiation of Phase 1b/2a studies of ARGX-119 to assess early signal detection in patients with CMS and ALS, the anticipated timing of the initiation of Phase 1 studies of ARGX-213 and ARGX-121; its investigational new drug applications for ARGX-2220 and ARGX-109 expected to be filed by the end of 2025; its 2024 research and development and selling, general and administrative expenses and operating expenses; its 2024 cash burn; and its goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the results of argenx's clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements in products and product candidates; the acceptance of argenx's products and product candidates by patients as safe, effective and cost-effective; the impact of governmental laws and regulations on our business; disruptions caused on our reliance of third parties suppliers, service provides and manufacturing; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

i reflects cash, cash equivalents and current financial assets


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MANAGEMENT REPORT

1.

MAIN EVENTS IN THE SIX MONTHS OF 2024

FIRST QUARTER OF 2024

See refer to our Q1 2024 press release

SECOND QUARTER OF 2024 AND RECENT BUSINESS UPDATE

“We were excited to unveil our ambition for the future of argenx – Vision 2030 – last week, outlining our plan to develop and deliver continued and sustainable innovation for patients,” said Tim Van Hauwermeiren, Chief Executive Officer, argenx. “We are already delivering on this promise with impressive commercial execution throughout the first half of the year, expanding our patient reach in MG, and launching in CIDP with our broad FDA label. Our development pipeline is stronger than ever, driven by our unique innovation engine. And we are well-positioned to capture the sizeable growth opportunity before us as we seek to reach earlier-line MG patients over the next 12-18 months with potential label expansions and a pre-filled syringe.”

Vision 2030

During its R&D Day on July 16, 2024, argenx unveiled its ‘Vision 2030’ as part of its long-term commitment to transform the treatment of autoimmune diseases by strengthening its leadership in neonatal Fc receptor (FcRn) biology, investing in its continuous pipeline of differentiated antibody candidates, and scaling in a disciplined way to ensure innovation remains core to the argenx mission. ‘Vision 2030’ includes the following goals:

50,000 patients globally on treatment with an argenx medicine
10 labeled indications across all approved assets, including VYVGART franchise and potentially empasiprubart and ARGX-119
Five new molecules in Phase 3 development indicating ongoing investment in internal discovery engine, the Immunology Innovation Program

Reaching 50,000 Patients Globally

VYVGART (efgartigimod alfa-fcab) is a first-in-class antibody fragment targeting FcRn and is now approved for both intravenous use and subcutaneous injection (SC) (efgartigimod alfa and hyaluronidase-qvfc) 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.

Generated global net product sales (inclusive of both VYVGART and VYVGART SC) of $876 million in the first six months of 2024
National Medical Products Administration (NMPA) approved VYVGART SC for treatment of gMG in China through Zai Lab on July 16, 2024
Additional VYVGART regulatory decisions on approval expected for gMG in 2024, including in Switzerland, Australia, and Saudi Arabia
Launched VYVGART Hytrulo in CIDP in U.S. with first patients injected in July
Multiple VYVGART SC regulatory submissions under review or planned for CIDP, including:
oRegulatory submissions completed in China, Japan, and Europe with decisions on approval expected in 2025
oRegulatory submission filing in Canada by end of 2024
Announced plan to evaluate VYVGART in ocular MG with registrational study (ADAPT OCULUS) to start by end of year; OCULUS to support label-expansion strategy into broader MG populations along with ongoing ADAPT SERON study in seronegative MG
Regulatory submission filed and under regulatory review for VYVGART SC pre-filled syringe (PFS) for gMG and CIDP

2

Advancing Pipeline to Achieve 10 Labeled Indications by 2030

argenx continues to demonstrate breadth and depth within its immunology pipeline, advancing multiple pipeline-in-a-product candidates. argenx is solidifying its leadership in FcRn biology, with efgartigimod currently in development in 15 indications. argenx is also advancing its first-in-class C2 inhibitor, empasiprubart, which is being evaluated in multifocal motor neuropathy (MMN), delayed graft function (DGF), dermatomyositis (DM), and CIDP. In addition, argenx is evaluating ARGX-119, a muscle-specific kinase (MuSK) agonist in both congenital myasthenic syndrome (CMS) and amyotrophic lateral sclerosis (ALS).

Registrational studies ongoing of efgartigimod in thyroid eye disease (TED)
Advancing development of efgartigimod in primary Sjogren’s disease (SjD) with Phase 3 study to begin by end of 2024
Following alignment meeting with FDA, confirmatory study of VYVGART (IV) in primary ITP to start by end of 2024 to enable registration in U.S.
Topline data from seamless Phase 2/3 ALKIVIA study evaluating efgartigimod across three myositis subsets (immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and DM expected in fourth quarter of 2024
Update on BALLAD study development plan evaluating efgartigimod in bullous pemphigoid (BP) expected by end of 2024
Proof-of-concept studies ongoing with efgartigimod in membranous nephropathy (MN) and lupus nephritis (LN) with studies expected to initiate this year in antibody mediated rejection (AMR) and systemic sclerosis (SSc)
Phase 3 study of empasiprubart for MMN to initiate in fourth quarter of 2024
CIDP nominated as fourth empasiprubart indication, recognizing opportunity to bring multiple innovative treatments to patients
Phase 1b/2a studies of ARGX-119 to assess early signal detection in patients with CMS and ALS to start by end of 2024

Investing in Immunology Innovation Program to Support Five New Molecules in Phase 3 by 2030

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 new class of medicine; ARGX-121, a first-in-class molecule targeting IgA;  ARGX-109, targeting IL-6, which plays an important role in inflammation, and ARGX-220,  a first-in-class sweeping antibody for which the target has not yet been disclosed.

Phase 1 studies of ARGX-213 and ARGX-121 expected to start in second half of 2025
Investigational new drug (IND) applications for ARGX-220 and ARGX-109 on track to be filed by end of 2025

2.FINANCIAL HIGHLIGHTS

Total operating income for the six months ended June 30, 2024, was $902 million compared to $511 million for the same period in 2023, and mainly consists of: 

Product net sales of VYVGART and VYVGART SC for the six months ended June 30, 2024, were $876 million compared to $487 million for the same period in 2023. 
Other operating income for the six months ended June 30, 2024, was $23 million compared to $21 million for the same period in 2023. The other operating income for the six months ended June 30, 2024 and 2023, primarily relates to research and development tax incentives.  

Total operating expenses for the six months ended June 30, 2024 were $1,041 million compared to $717 million for the same period in 2023, and mainly consists of: 

Cost of sales for the six months ended June 30, 2024, was $96 million compared to $42 million for the same period in 2023. The cost of sales was recognized with respect to the sale of VYVGART and VYVGART SC. 

3

Research and development expenses for the six months ended June 30, 2024, were $450 million compared to $361 million for the same period in 2023. The research and development expenses mainly relate to external research and development expenses and personnel expenses incurred in the clinical development of efgartigimod in various indications and the expansion of other clinical and preclinical pipeline candidates. 
Selling, general and administrative expenses for the six months ended June 30, 2024, were $492 million compared to $311 million for the same period in 2023. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the commercialization of VYVGART and VYVGART SC, and personnel expenses. 

Financial income for the six months ended June 30, 2024, was $78 million compared to $37 million for the same period in 2023. The increase in financial income is mainly due to an increase in interest income coming from an increase of cash, cash equivalents and current financial assets as a result of the July 2023 financing round. 

Exchange losses for the six months ended June 30, 2024, were $27 million compared to $9 million of exchange gains for the same period in 2023. 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 six months ended June 30, 2024, was $57 million of income tax benefit compared to $37 million of income tax benefit for the same period in 2023. Income tax benefit for the six months ended June 30, 2024, consists of $16 million of current income tax expense and $73 million of deferred tax benefit, compared to $23 million of current income tax expense and $59 million of deferred tax benefit for the comparable prior period. 

Loss for the six months ended June 30, 2024 was $33 million compared to $123 million for the same period in 2023. On a per weighted average share basis, the basic loss per share was $0.55 and $2.21 for the six months ended June 30, 2024 and 2023, respectively.  

Cash, cash equivalents and current financial assets totalled $3.1 billion as of June 30, 2024, compared to $3.2 billion as of December 31, 2023. The decrease in cash and cash equivalents and current financial assets result from net cash flows used in operating activities. 

3.RISK FACTORS

We refer to the description of risk factors in the 2023 annual report, pp. 97-143 as supplemented by the description of risk factors in our annual report on Form 20-F filed with the U.S. Securities and Exchange Commission, pp. 1-39. In summary, the principal risks and uncertainties faced by us relate to: our financial position and need for additional capital, commercialization of our products and product candidates, including new indications, government regulations, development and clinical testing of our products and product candidates, dependence on third parties, business and industry, intellectual property, our organization and operations.

We also refer to the description of our financial risk management given in the 2023 annual report, pp. F40-F44, which remains valid.

4.FORWARD-LOOKING STATEMENTS

The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “advance,” “aim,” “anticipates,” “continue,” “expect,” “expand,” “plan,” or “seek”  and include statements argenx makes regarding its Vision 2030 plan to develop and deliver continued and sustainable innovation for patients; its long-term commitments; its Vision 2030 goals, including having 50,000 patients globally on treatment with an argenx medicine, 10 labeled indications across all approved assets,

4

including VYVGART franchise and potentially empasiprubart and ARGX-119, and five new molecules in Phase 3 development indicating ongoing investment in the immunology innovation program; its growth opportunity; its plans to reach earlier-line MG patients over the next 12-18 months with potential label expansions and a pre-filled syringe; the advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the anticipated timing of four additional Phase 3 registrational studies across efgartigimod and empasiprubart, the expected timing of additional VYVGART regulatory decisions on approval for gMG, including in Switzerland, Australia, and Saudi Arabia, the expected timing of additional VYVGART SC regulatory submissions under review or planned for CIDP, including decisions on approval in China, Japan, and Europe and a regulatory submission filing in Canada, the anticipated timing of the initiation of a Phase 3 study for efgartigimod in primary Sjogren’s disease (SjD), the anticipated timing of a confirmatory study of VYVGART (IV) in primary ITP,  the anticipated timing of topline data from Phase 2/3 ALKIVIA study evaluating efgartigimod across three myositis subsets, the anticipated timing of an update on BALLAD study development plan evaluating efgartigimod in BP, the anticipated timing of proof-of-concept studies for efgartigimod in AMR and SSc, the anticipated timing of the initiation of a Phase 3 study of empasiprubart for MMN, the anticipated timing of the initiation of Phase 1b/2a studies of ARGX-119 to assess early signal detection in patients with CMS and ALS, the anticipated timing of the initiation of Phase 1 studies of ARGX-213 and ARGX-121; its investigational new drug applications for ARGX-2220 and ARGX-109 expected to be filed by the end of 2025; its 2024 research and development and selling, general and administrative expenses and operating expenses; its 2024 cash burn; and its goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the results of argenx's clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements in products and product candidates; the acceptance of argenx's products and product candidates by patients as safe, effective and cost-effective; the impact of governmental laws and regulations on our business; disruptions caused on our reliance of third parties suppliers, service provides and manufacturing; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

STATEMENT OF THE BOARD OF DIRECTORS

We hereby certify that, to the best of our knowledge, the unaudited condensed consolidated interim financial statements of argenx SE as of and for the six months ended June 30, 2024, prepared in accordance with IAS 34 “Interim Financial Reporting” as issued by the IASB and as adopted by the European Union, gives a true and fair view of the assets, liabilities, financial position and total comprehensive income of the Company and the undertakings included in the consolidation as a whole, and that the management report includes a fair review of the development and performance of the business and the position of the Company and the undertakings included in the consolidation taken as a whole, together with a description of the principal risks and uncertainties that they face.

On behalf of the Board of Directors

Tim van Hauwermeiren, CEO

5

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

ARGENX SE

UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION

As of

June 30,

December 31,

(in thousands of $)

    

Note

    

2024

    

2023

ASSETS

 

  

 

  

 

 

  

Noncurrent assets

 

  

  

 

Property, plant and equipment

 

$

36,931

 

$

22,675

Intangible assets

 

141,774

 

125,228

Deferred tax asset

14

174,626

97,211

Research and development incentive receivables

 

91,237

 

76,706

Investment in joint venture

6,599

9,912

Prepaid expenses

47,327

47,327

Other non-current assets

4

34,276

39,662

Total noncurrent assets

 

  

532,770

 

418,721

Current assets

 

  

  

 

  

Inventories

5

$

326,460

$

310,550

Prepaid expenses

 

179,420

 

134,072

Trade and other receivables

6

652,875

496,687

Research and development incentive receivables

 

2,686

 

2,584

Financial assets

 

1,664,100

 

1,131,000

Cash and cash equivalents

 

7

1,438,247

 

2,048,844

Total current assets

 

4,263,788

 

4,123,737

TOTAL ASSETS

 

  

$

4,796,558

 

$

4,542,458

The accompanying notes form an integral part of these unaudited condensed consolidated interim financial statements

6

As of

June 30,

December 31,

(in thousands of $)

    

Note

    

2024

    

2023

EQUITY AND LIABILITIES

 

  

 

 

  

 

 

  

Equity

 

8

 

  

 

  

Equity attributable to owners of the parent

 

 

  

 

  

Share capital

 

 

$

7,118

 

$

7,058

Share premium

 

 

5,747,441

 

5,651,497

Translation differences

128,935

131,543

Accumulated losses

 

 

(2,437,375)

 

(2,404,844)

Other reserves

 

 

816,128

 

712,253

Total equity

 

 

$

4,262,247

 

$

4,097,507

Non-current liabilities

 

 

 

Provisions for employee benefits

 

 

1,581

 

1,449

Lease liabilities

28,107

15,354

Deferred tax liabilities

14

4,994

5,155

Total non-current liabilities

  

34,682

21,958

  

  

  

Current liabilities

 

  

 

 

Lease liabilities

5,853

4,646

Trade and other payables

 

10

 

479,829

 

414,013

Tax liabilities

13,947

4,334

Total current liabilities

  

499,629

422,993

  

Total liabilities

 

  

 

$

534,311

 

$

444,951

TOTAL EQUITY AND LIABILITIES

 

  

 

$

4,796,558

 

$

4,542,458

The accompanying notes form an integral part of these unaudited condensed consolidated interim financial statements.

7

ARGENX SE

UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS

Six Months Ended

June 30,

(in thousands of $ except for shares and EPS)

    

Note

    

2024

    

2023

Product net sales

11

$

875,918

$

487,335

Collaboration revenue

2,718

2,355

Other operating income

    

    

23,305

    

21,225

Total operating income

 

  

 

901,941

 

510,915

Cost of sales

(95,561)

(42,359)

Research and development expenses

 

12

 

(450,255)

 

(361,364)

Selling, general and administrative expenses

 

13

 

(491,694)

 

(311,149)

Loss from investment in joint venture

(3,313)

(1,880)

Total operating expenses

(1,040,823)

(716,752)

Operating loss

 

 

$

(138,882)

 

$

(205,837)

Financial income

 

 

77,828

 

37,029

Financial expense

(1,084)

(395)

Exchange gains/(losses)

 

 

(27,215)

 

9,164

  

  

Loss for the period before taxes

 

 

$

(89,353)

 

$

(160,039)

Income tax benefit

 

14

 

$

56,822

 

$

36,800

Loss for the period

 

 

$

(32,531)

 

$

(123,239)

Loss for the period attributable to:

Owners of the parent

(32,531)

$

(123,239)

Weighted average number of shares outstanding

 

  

 

59,400,217

 

55,690,873

Basic and diluted (loss) per share (in $)

 

 

(0.55)

 

(2.21)

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

8

ARGENX SE

UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

Six Months Ended

June 30,

(in thousands of $)

    

Note

    

2024

    

2023

Loss for the period

    

    

$

(32,531)

    

$

(123,239)

Items that may be reclassified subsequently to profit or loss, net of tax

Currency translation differences, arisen from translating foreign activities

(2,608)

762

Items that will not be reclassified to profit or loss, net of tax

Fair value gain/(loss) on investments in equity instruments designated as at FVTOCI

4

(5,682)

(1,688)

Other comprehensive loss, net of income tax

(8,290)

(926)

Total comprehensive loss attributable to:

Owners of the parent

$

(40,821)

$

(124,165)

The accompanying notes form an integral part of these unaudited condensed consolidated interim financial statements.

9

ARGENX SE

UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS

Six Months Ended

June 30,

(in thousands of $)

    

Note

    

2024

    

2023

Operating loss

 

  

 

$

(138,882)

 

$

(205,837)

Adjustments for non-cash items

 

  

 

  

 

  

Amortization of intangible assets

 

 

4,956

 

43

Depreciation of property, plant and equipment

 

 

3,667

 

2,661

Provisions for employee benefits

 

 

143

 

138

Expense recognized in respect of share-based payments

 

9

 

102,381

 

102,083

Fair value gains on financial assets at fair value through profit or loss

(445)

Loss from investment in joint venture

3,313

1,880

Other non-cash expenses

8

 

  

 

$

(24,859)

 

$

(99,032)

Movements in current assets/liabilities

 

  

 

  

 

  

(Increase)/decrease in trade and other receivables

 

6

 

(97,612)

 

(68,057)

(Increase)/decrease in inventories

5

(16,072)

27,240

(Increase)/decrease in other current assets

 

 

 

(45,821)

 

(62,500)

Increase/(decrease) in trade and other payables

 

10

 

76,710

 

(616)

Movements in non-current assets/liabilities

(Increase)/decrease in other non‑current assets

 

4

 

(18,139)

 

(11,603)

(Increase)/decrease in non-current prepaid expense

(47,327)

Net cash flows used in operating activities, before interest and taxes

(125,793)

(261,894)

Interest paid

(157)

(78)

Income taxes received/(paid)

1,294

(23,465)

Net cash flows used in operating activities

 

  

 

$

(124,656)

 

$

(285,436)

Purchase of intangible assets

 

 

(21,500)

 

Purchase of property, plant and equipment

 

 

(811)

 

(479)

Purchase of current financial assets

7

(1,108,410)

(267,196)

Sale of current financial assets

7

568,410

780,331

Interest received

48,552

27,361

Investment in joint venture

 

 

 

(13,000)

Net cash flows from / (used in) investing activities

 

  

 

$

(513,759)

 

$

527,017

Principal elements of lease payments

 

 

(3,604)

 

(2,182)

Payment of employee withholding taxes relating to restricted stock unit awards

(1,792)

(604)

Proceeds from exercise of stock options

8

45,470

65,074

Net cash flows from financing activities

 

  

 

$

40,074

 

$

62,288

Increase/(decrease) in cash and cash equivalents

 

  

 

$

(598,341)

 

$

303,868

Cash and cash equivalents at the beginning of the period

 

  

 

$

2,048,844

 

$

800,740

Exchange gains/(losses) on cash and cash equivalents

 

 

$

(12,256)

 

$

5,960

Cash and cash equivalents at the end of the period

 

  

 

$

1,438,247

 

$

1,110,567

The accompanying notes form an integral part of these unaudited condensed consolidated interim financial statements.

10

ARGENX SE

UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY

Attributable to owners of the parent

   

   

   

   

   

Share-based

   

   

Total

  

  

payment and

equity

 

 

 

income tax

Fair value movement on

attributable

 

deduction on

investment in equity

to owners

Share

Share

Accumulated

Translation

share-based

instruments designated

of the

Total

(in thousands of $)

capital

premium

losses

 

differences

payments

as at FVTOCI

 

parent

equity

Balance year ended December 31, 2022

 

$

6,640

4,309,880

(2,109,791)

129,280

535,247

(57,557)

2,813,699

2,813,699

Loss for the year

(123,239)

(123,239)

(123,239)

Other comprehensive income / (loss)

762

(1,688)

(926)

(926)

Total comprehensive income / (loss) for the year

(123,239)

 

762

(1,688)

(124,165)

  

 

(124,165)

Income tax benefit from excess tax deductions related to share-based payments

1,396

1,396

1,396

Share-based payment

 

102,651

102,651

  

 

102,651

Exercise of stock options

 

58

65,016

65,074

  

 

65,074

Ordinary shares withheld for payment of employees’ withholding tax liability

(604)

(604)

(604)

Balance year ended June 30, 2023

 

$

6,698

 

$

4,374,291

 

$

(2,233,029)

 

$

130,042

$

639,294

$

(59,245)

 

$

2,858,051

  

 

$

2,858,051

Balance year ended December 31, 2023

 

$

7,058

 

$

5,651,497

 

$

(2,404,844)

 

$

131,543

$

771,725

$

(59,472)

 

$

4,097,507

  

 

$

4,097,507

Loss for the period

(32,531)

(32,531)

(32,531)

Other comprehensive income / (loss)

(2,608)

(5,682)

(8,290)

(8,290)

Total comprehensive income / (loss) for the period

(32,531)

 

(2,608)

(5,682)

(40,821)

  

 

(40,821)

Income tax benefit from excess tax deductions related to share-based payments

7,013

7,013

7,013

Share-based payment

 

102,544

102,544

  

 

102,544

Exercise of stock options

 

60

97,736

97,796

  

 

97,796

Ordinary shares withheld for payment of employees’ withholding tax liability

(1,792)

(1,792)

(1,792)

Balance year ended June 30, 2024

 

$

7,118

 

$

5,747,441

 

$

(2,437,375)

 

$

128,935

$

881,282

$

(65,154)

 

$

4,262,247

  

 

$

4,262,247

Please refer to note 8 for more information on the share capital.

The accompanying notes form an integral part of these unaudited condensed consolidated interim financial statements.

11

ARGENX SE

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

1. General information about the company

argenx SE (the Company) is a Dutch European public company with limited liability incorporated under the laws of the Netherlands. The Company (COC 24435214) has its official seat in Rotterdam, the Netherlands, and its registered office is at Laarderhoogteweg 25, 1101 EB Amsterdam, the Netherlands.

argenx SE is a publicly traded company with ordinary shares listed on Euronext Brussels under the symbol “ARGX” since July 2014 and with American Depositary Shares listed on Nasdaq under the symbol “ARGX” since May 2017.

2. Basis of preparation

The unaudited condensed consolidated interim financial statements for the six months ended June 30, 2024 have been prepared in accordance with IAS 34 ‘Interim Financial Reporting’ as issued by the IASB and as adopt