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 2023

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 27, 2023, argenx SE (the “Company) issued a press release and unaudited first half-year financial results for 2023, which are further described in an Unaudited Interim Report for the Six Months Ended June 30, 2023, 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 the exhibits hereto, is incorporated by reference into the Company’s Registration Statements on Forms F-3 (File No. 333-258251 and S-8 (File Nos. 333-225375 and 333-258253).

 


EXHIBITS

Exhibit

Description

99.1

Press Release dated July 27, 2023

99.2

Unaudited Interim Report for the Six Months Ended June 30, 2023

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 27, 2023

By:

/s/ Hemamalini (Malini) Moorthy

Hemamalini (Malini) Moorthy

General Counsel


Exhibit 99.1

Graphic

argenx Reports Half Year 2023 Financial Results and Provides Second Quarter Business Update

-$269 million in second quarter VYVGART® (efgartigimod alfa-fcab) global net product sales

-VYVGART® Hytrulo now available in the U.S. with first vials shipped in July

-Global VYVGART expansion continued with commercial launch in Italy and distribution agreement with Handok in South Korea

-Topline results from ADVANCE-SC and ADDRESS expected in fourth quarter of 2023

-Management to host conference call today at 2:30 pm CET (8:30 am ET)


July 27, 2023

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 2023 financial results and provided a second quarter business update.

“We are thrilled to see the momentum continue across all aspects of our business, with a catalyst-rich first half of the year. For another quarter we saw consistent revenue growth with VYVGART, delivering on our promise to bring transformative change to the treatment of gMG and reaching more patients through global approvals and the launch of our SC offering. Now with the positive ADHERE data, we have strengthened our conviction in the potential of VYVGART for CIDP patients but also more broadly across IgG-mediated autoimmune diseases, motivating us to explore the full extent of the opportunity. Our ambition level is high and we are positioning argenx for long-term growth with VYVGART, empasiprubart, and our pipeline of immunology solutions. It is time to raise the bar for patients on what a treatment can offer and we are more inspired than ever in our pursuit to do so,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

SECOND QUARTER 2023 AND RECENT BUSINESS UPDATE

VYVGART Expansion

VYVGART is a first-in-class antibody fragment targeting the neonatal Fc receptor (FcRn) and is now approved globally in six countries or regions (U.S., Japan, EU, UK, Israel, China) for generalized myasthenia gravis (gMG). VYVGART Hytrulo was approved by the U.S. Food and Drug Administration (FDA) on June 20, 2023, and is the first subcutaneous (SC) injectable for gMG. argenx is planning for multi-dimensional expansion to reach more patients with VYVGART through additional global regulatory approvals.

Generated global net VYVGART revenues of $269 million in second quarter of 2023
Launched VYVGART Hytrulo in U.S. and shipped first vials in July
Launched VYGART in Italy in July following successful completion of reimbursement negotiations
VYVGART approval decision in Canada expected in third quarter of 2023
Approval decisions of SC efgartigimod expected in Europe in fourth quarter of 2023, Japan by first quarter of 2024, and China by end of 2024
Marketing authorization application (MAA) filed in Japan for VYVGART for primary immune thrombocytopenia (ITP); approval decision expected in first half of 2024
Entered into VYVGART commercial and distribution agreement with Handok in South Korea


Efgartigimod Research and Development

argenx is solidifying its leadership in immunology innovation by expanding the scope of IgG-mediated autoimmune diseases in development and further demonstrating the potential of FcRn blockade in ongoing clinical trials. By the end of 2023, efgartigimod is expected to be approved, in regulatory review or in development in 13 severe autoimmune diseases.

Announced positive topline results from ADHERE of VYVGART Hytrulo for chronic inflammatory demyelinating polyneuropathy (CIDP)
oPrimary endpoint met (p=0.000039); VYVGART Hytrulo demonstrated 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in risk of relapse versus placebo
o67% of patients in open-label Stage A demonstrated evidence of clinical improvement (ECI), indicating IgG autoantibodies play significant role in underlying biology of CIDP
oSafety and tolerability profile consistent with confirmed safety profile of VYVGART
o91% (226/249) of eligible patients continued to ADHERE+ open-label extension study
Topline data from ADDRESS (pemphigus) and ADVANCE-SC (primary immune thrombocytopenia) studies expected in fourth quarter of 2023
GO/NO GO decisions expected from BALLAD (bullous pemphigoid) in first quarter of 2024 and ALKIVIA (myositis) in second half of 2024
Topline data from ALPHA (post-COVID postural orthostatic tachycardia syndrome (PC-POTS)) expected in first quarter of 2024 and RHO (Sjogren’s syndrome) in second half of 2024
Studies ongoing in membranous nephropathy (MN) and lupus nephritis (LN) through Zai Lab collaboration
Registrational study in thyroid eye disease (TED) and proof-of-concept studies in ANCA-associated vasculitis (ANCA) and antibody mediated rejection (AMR) in kidney transplant to start in fourth quarter of 2023

Pipeline Progress

argenx is advancing a robust portfolio of innovative clinical programs, including empasiprubart (C2 inhibitor) and ARGX-119 (muscle-specific kinase (MuSK) agonist). Both programs have the potential to be first-in-class opportunities for multiple severe indications.

Initiated second dose cohort in Phase 2 ARDA study of empasiprubart in multifocal motor neuropathy (MMN)
oIndependent Data Monitoring Committee recommended study continuation based on favorable safety profile observed in first dose cohort
oEarly efficacy signals support proof-of-concept in MMN
oSecond cohort to evaluate next dose of empasiprubart based on efficacy signals observed in first cohort
oTopline results from both first and second cohorts expected in 2024
Phase 2 studies of empasiprubart in delayed graft function (DGF) on track to start by end of year and dermatomyositis in first quarter of 2024
Phase 1 study of ARGX-119 ongoing in healthy volunteers; subsequent Phase 1b trial to assess early signal detection in patients with congenital myasthenic syndrome and amyotrophic lateral sclerosis (ALS)

Immunology Innovation Program

argenx continues to invest in its discovery engine, the Immunology Innovation Program, to foster a robust innovation ecosystem and drive early-stage pipeline growth. argenx expects to nominate one new pipeline candidate in 2023.


SECOND QUARTER 2023 FINANCIAL RESULTS

Three Months Ended
June 30,

Six Months Ended
June 30,

(in thousands of $ except for shares and EPS)

2023

2022

2023

2022

Product net sales

 

$

269,313

$

74,833

$

487,335

$

95,996

Collaboration revenue

1,237

361

2,355

2,610

Other operating income

 

10,485

9,989

21,225

18,057

Total operating income

281,035

85,183

510,915

116,663

 

 

Cost of sales

(24,024)

(5,010)

(42,359)

(6,382)

Research and development expenses

 

(195,509)

(126,919)

(361,364)

(278,887)

Selling, general and administrative expenses

(161,977)

(127,798)

(311,149)

(228,664)

Loss from investment in joint venture

 

(1,619)

-

(1,880)

-

Total operating expenses

(383,129)

(259,727)

(716,752)

(513,933)

 

 

Operating loss

$

(102,094)

$

(174,544)

$

(205,837)

$

(397,270)

 

 

Financial income

20,441

4,912

37,029

5,733

Financial expense

 

(207)

(1,178)

(395)

(2,131)

Exchange gains/(losses)

(2,001)

(46,169)

9,164

(53,382)

 

 

Loss for the period before taxes

$

(83,861)

$

(216,979)

$

(160,039)

$

(447,050)

Income tax (expense)/benefit

 

$

(10,507)

$

8,229

$

36,800

$

11,114

Loss for the period

$

(94,368)

$

(208,750)

$

(123,239)

$

(435,936)

Loss for the period attributable to:

 

Owners of the parent

$

(94,368)

$

(208,750)

$

(123,239)

$

(435,936)

Weighted average number of shares outstanding

 

55,828,239

54,802,339

55,690,873

53,449,915

Basis and diluted loss per share (in $)

(1.69)

(3.81)

(2.21)

(8.16)

Net increase/(decrease) in cash, cash equivalents and current financial assets compared to year-end 2021 and 2022

 

(195,580)

260,665

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

1,996,968

2,597,393

DETAILS OF THE FINANCIAL RESULTS

Total operating income for the second quarter and year-to-date in 2023 was $281.0 million and $510.9 million, respectively, compared to $85.2 million and $116.7 million for the same periods in 2022, and mainly consists of:

Product net sales of VYVGART for the three months ended and six months ended June 30, 2023, were $269.3 million and $487.3 million, compared to $74.8 million and $96.0 million for the same periods in 2022.
Other operating income for the second quarter and year-to-date in 2023 was $10.5 million and $21.2 million, respectively, compared to $10.0 million, and $18.1 million for the same periods in 2022. The other operating income for the three and six months ended June 30, 2023 primarily relates to research and development tax incentives and payroll tax rebates.

Total operating expenses for the second quarter and year-to-date in 2023 were $383.1 million and $716.8 million, respectively, compared to $259.7 million and $513.9 million for the same periods in 2022, and mainly consists of:

Cost of sales for the second quarter and year-to-date in 2023 was $24.0 million and $42.4 million, respectively, compared to $5.0 million and $6.4 million for the same periods in 2022. The cost of sales was recognized with respect to the sale of VYVGART.


Research and development expenses increased by $68.6 million and $82.5 million for the three months and six months ended June 30, 2023, to $195.5 million and $361.4 million, respectively, compared to $126.9 million and $278.9 million for the same periods in 2022. 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 second quarter and year-to-date in 2023 were $162.0 million and $311.1 million, respectively, compared to $127.8 million and $228.7 million for the same periods in 2022. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to commercialization of VYVGART in the U.S., EU and Japan, and personnel expenses.

Financial income for the second quarter and year-to-date in 2023 was $20.4 million and $37.0 million, respectively, compared to $4.9 million and $5.7 million for the same periods in 2022. The increase in financial income is mainly due to an increase in interest income on current financial assets and cash and cash equivalents attributable to higher interest rates.

Exchange gains/losses for the second quarter and year-to-date in 2023 were $2.0 million of exchange losses and $9.2 million of exchange gains, respectively, compared to $46.2 million and $53.4 million  of exchange losses for the same periods in 2022. Exchange gains/losses are mainly attributable to unrealized exchange rate gains or losses on the cash, cash equivalents and current financial assets position in Euro.

Income tax for the second quarter and year-to-date in 2023 was $10.5 million of tax expense and $36.8 million of tax benefit, respectively, compared to $8.2 million and $11.1 million of tax benefit for the same periods in 2022.

Net loss for the three and six month periods ended June 30, 2023, was $94.4 million and $123.2 million, respectively, compared to $208.8 million and $435.9 million over the prior year periods. On a per weighted average share basis, the net loss was $2.21 and $8.16 for the six months ended June 30, 2023 and 2022, respectively.

Cash, cash equivalents and current financial assets totalled $2.0 billion as of June 30, 2023, compared to $2.2 billion as of December 31, 2022. Cash and cash equivalents and current financial assets decreased primarily as a result of net cash flows used in operating activities. The cash position as of June 30, 2023, excludes the $1.3 billion in estimated gross proceeds from the global equity offering, which closed on July 24, 2023.  

With the closing of this transaction, argenx will review its cash burn expectations and provide an update accordingly.

UPCOMING FINANCIAL CALENDAR

October 31, 2023: Q3 2023 financial results and business update
February 29, 2024: FY 2023 financial results and business update

CONFERENCE CALL DETAILS

The second quarter 2023 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. A replay of the webcast will be available on the argenx website.

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 1 888 415 4250

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 in the U.S., Japan, Israel, the EU, the UK and China. 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, Twitter, and Instagram.

For further information, please contact:

Media:

Erin Murphy

emurphy@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 “believes,” “hope,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should” and include statements argenx makes regarding its plans for its global commercial expansion of VYVGART to reach more patients; continued investment in its Immunology Innovation Program to foster a robust innovation ecosystem and drive early-stage pipeline growth; the therapeutic potential of its product candidates; the intended results of its strategy and its collaboration partners’, including ongoing studies through its collaboration with Zai Lab; advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the (1) expected topline data from registrational ADDRESS and ADVANCE-SC studies in 2023, (2) expected GO/NO GO decisions from its BALLAD and ALKIVIA trials in 2024, (3) expected topline data from its ALPHA and RHO trials in 2024, (4) timeline of registrational and proof-of-concept studies in ANCA-associated vasculitis and antibody mediated rejection in kidney transplant, (5) potential of empasiprubart and ARGX-119 to be first-in-class opportunities for multiple serious indications and timeline of studies and results thereof and (6) planned nomination of a new product development candidate in 2023; the timing and outcome of regulatory filings and regulatory approvals, including the anticipated regulatory approvals of VYVGART in Canada and Japan and approvals of SC efgartigimod in Europe, Japan and China, and the number of autoimmune diseases for which efgartigimod is expected to be approved, in regulatory review or in development by end of 2023; and 2023 business and financial outlook and related plans, including the anticipated release of updated cash burn expectations and the timeline of future releases of financial results and business updates. 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 inflation and deflation and the corresponding fluctuations in interest rate; regional instability and conflicts, such as the conflict between Russia and Ukraine, argenx’s expectations regarding the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; argenx’s reliance on cllaborations with third parties; estimating the commercial potential of argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. 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.


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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

    

2023

    

2022

ASSETS

 

 

 

  

 

 

  

Noncurrent assets

Property, plant and equipment

$

14,676

 

$

16,234

Intangible assets

189,857

 

174,901

Deferred tax asset

138,767

79,222

Other non-current assets

4

39,232

 

40,894

Research and development incentive receivables

59,976

 

47,488

Investment in joint venture

12,443

1,323

Prepaid expenses

5

47,327

Total noncurrent assets

$

502,277

 

$

360,064

Current assets

 

 

  

 

  

Inventories

6

$

201,112

$

228,353

Prepaid expenses

 

 

138,825

 

76,022

Trade and other receivables

 

7

 

353,232

 

275,697

Research and development incentive receivables

 

 

1,377

 

1,578

Financial assets

 

8, 18

 

886,401

 

1,391,808

Cash and cash equivalents

 

9, 18

 

1,110,567

 

800,740

Total current assets

 

 

$

2,691,514

 

$

2,774,197

TOTAL ASSETS

 

 

$

3,193,791

 

$

3,134,261

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

2

As of

June 30,

December 31,

(in thousands of $)

    

Note

    

2023

    

2022

EQUITY AND LIABILITIES

 

 

 

  

 

 

  

Equity

 

 

  

 

  

Equity attributable to owners of the parent

 

10

 

  

 

  

Share capital

 

 

$

6,698

 

$

6,640

Share premium

 

4,374,291

 

4,309,880

Translation Differences

130,042

129,280

Accumulated losses

 

 

(2,233,029)

 

(2,109,791)

Other reserves

 

 

580,049

 

477,691

Total equity

 

 

$

2,858,051

 

$

2,813,699

Non-current liabilities

 

 

 

Provisions for employee benefits

 

 

$

1,011

 

$

870

Lease liabilities

8,044

9,009

Deferred tax liabilities

8,894

8,406

Total non-current liabilities

$

17,949

$

18,285

Current liabilities

 

 

Lease liabilities

$

3,198

$

3,417

Trade and other payables

12

309,985

295,679

Tax liabilities

4,608

3,181

Total current liabilities

$

317,791

$

302,277

Total liabilities

 

 

$

335,740

 

$

320,562

TOTAL EQUITY AND LIABILITIES

 

 

$

3,193,791

 

$

3,134,261

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

3

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

2023

    

2022

Product net sales

    

13,14

$

487,335

    

$

95,996

Collaboration revenue

2,355

2,610

Other operating income

 

21,225

 

18,057

Total operating income

 

510,915

 

116,663

Cost of sales

(42,359)

(6,382)

Research and development expenses

 

15

(361,364)

 

(278,887)

Selling, general and administrative expenses

 

16

(311,149)

 

(228,664)

Loss from investment in joint venture

(1,880)

Total operating expenses

(716,752)

(513,933)

Operating loss

 

$

(205,837)

 

$

(397,270)

Financial income

 

37,029

 

5,733

Financial expense

(395)

(2,131)

Exchange gains/(losses)

 

9,164

 

(53,382)

Loss for the period before taxes

 

  

$

(160,039)

 

$

(447,050)

Income tax benefit

 

17

$

36,800

 

$

11,114

Loss for the period

 

  

$

(123,239)

 

$

(435,936)

Loss for the period attributable to:

Owners of the parent

(123,239)

(435,936)

Weighted average number of shares outstanding

 

  

55,690,873

 

53,449,915

Basic and diluted loss per share (in $)

 

(2.21)

 

(8.16)

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

4

ARGENX SE

UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME AND LOSS

Six Months Ended

June 30,

(in thousands of $ except for shares)

    

Note

2023

    

2022

Loss for the period

    

$

(123,239)

    

$

(435,936)

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

Currency translation differences, arisen from translating foreign activities

762

(2,993)

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

18

(1,688)

(16,006)

 

 

Other comprehensive loss, net of income tax

 

$

(926)

 

$

(18,999)

Total comprehensive loss attributable to:

 

$

(124,165)

 

$

(454,935)

Owners of the parent

 

(124,165)

 

(454,935)

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

5

ARGENX SE

UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS

Six Months Ended

June 30,

(in thousands of $)

    

Note

    

2023

    

2022

Operating loss

 

  

 

$

(205,837)

 

$

(397,270)

Adjustments for non-cash items

 

  

 

 

  

Amortization of intangible assets

 

 

43

 

389

Depreciation of property, plant and equipment

 

 

2,661

 

2,671

Provisions for employee benefits

138

137

Expense recognized in respect of share-based payments

 

11

 

102,083

 

76,634

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

(4,256)

Loss from investment in joint venture

1,880

 

 

$

(99,032)

 

$

(321,695)

Movements in current assets/liabilities

 

 

  

 

  

(Increase)/decrease in trade and other receivables

 

 

(68,057)

 

(71,152)

(Increase)/decrease in inventories

6

27,240

(26,636)

(Increase)/decrease in other current assets

 

 

(62,500)

 

(25,119)

Increase/(decrease) in trade and other payables

 

 

(616)

 

(33,251)

Movements in non-current assets/liabilities

(Increase)/decrease in non‑current prepaid expenses

(47,327)

(Increase)/decrease in other non‑current assets

 

 

(11,603)

 

(7,244)

Cash flows used in operating activities

$

(261,894)

$

(485,097)

Interest paid

(78)

(505)

Income taxes paid

(23,465)

(8,911)

Net cash flows used in operating activities

 

 

$

(285,436)

 

$

(494,513)

 

 

  

 

  

Purchase of property, plant and equipment

 

 

(479)

 

(183)

(Increase)/decrease in current financial assets

8

(234,244)

Purchase of current financial investments (1)

(267,196)

Sale of current financial investments (1)

780,331

Interest received

 

 

27,361

 

2,082

Investment in joint venture

(13,000)

Net cash flows (used in) / from investing activities

 

 

$

527,017

 

$

(232,345)

 

 

  

 

  

Principal elements of lease payments

(2,182)

(2,224)

Proceeds from issue of new shares, gross amount

 

10

 

 

760,954

Issue costs paid

(843)

Exchange gain from currency conversion on proceeds from issue of new shares

10

410

Payment on employee withholding taxes related to restricted stock unit awards

(604)

Proceeds from exercise of stock options

10

65,074

49,979

Net cash flows from financing activities

 

 

$

62,288

 

$

808,276

Increase/(decrease) in cash and cash equivalents

 

 

$

303,868

 

$

81,418

Cash and cash equivalents at the beginning of the period

 

  

 

$

800,740

 

$

1,334,676

Exchange gains/(losses) on cash & cash equivalents

 

 

$

5,960

 

$

(48,806)

Cash and cash equivalents at the end of the period

 

  

 

$

1,110,567

 

$

1,367,288

(1) Due to the change in the maturity of the current financial assets during current year, the presentation has been changed from net basis to gross basis

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

6

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

Attributable

 

deduction on

Other

to Owners

Share

Share

Accumulated

Translation

share-based

comprehensive

of the

Total

(in thousands of $)

Capital

Premium

Losses

 

Difference

 

payments

 

income

 

Parent

Equity

Balance year ended December 31, 2021

 

$

6,233

 

$

3,462,775

 

$

(1,400,197)

 

$

131,684

 

$

373,019

$

(39,290)

 

$

2,534,224

  

 

$

2,534,224

Loss for the period

 

$

 

$

 

$

(435,936)

$

$

$

$

(435,936)

$

(435,936)

Other comprehensive income / (loss)

(2,993)

(16,006)

(18,999)

(18,999)

Total comprehensive income/(loss) for the period

(435,936)

(2,993)

(16,006)

(454,935)

(454,935)

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

3,957

3,957

3,957

Share-based payment

 

 

 

  

 

76,935

76,935

  

 

76,935

Issue of share capital

294

 

760,659

 

  

 

760,953

  

 

760,953

Transaction costs for equity issue

(781)

(781)

(781)

Exercise of stock options

 

76

 

49,842

 

  

 

49,919

  

 

49,919

Balance period ended June 30, 2022

 

$

6,603

 

$

4,272,495

 

$

(1,836,133)

 

$

128,691

 

$

453,911

$

(55,296)

 

$

2,970,271

  

 

$

2,970,271

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

Total loss of the period

 

$

  

 

$

  

 

$

(123,239)

$

  

 

$

  

$

  

 

$

(123,239)

$

(123,239)

Other comprehensive income / (loss)

762

(1,688)

(926)

(926)

Total comprehensive income/(loss) for the period

(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 period ended June 30, 2023

 

$

6,698

 

$

4,374,291

 

$

(2,233,029)

 

$

130,042

 

$

639,294

$

(59,245)

 

$

2,858,051

  

 

$

2,858,051

Please refer to note 10 for more information on the share capital.

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

7

ARGENX SE

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

1. General information about the Company

argenx SE 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, 2023 have been prepared in accordance with IAS 34 ‘Interim Financial Reporting’ as issued by the IASB and as adopted by the European Union. The unaudited condensed consolidated interim financial statements should be read in conjunction with the annual financial statements for the year ended December 31, 2022.

All amounts herein are presented in thousands of $, unless otherwise indicated, rounded to the nearest $ ‘000.

The unaudited condensed consolidated financial statements have been approved for issue by the Company’s Board of Directors (the “Board”) on July 25, 2023.

3. Significant accounting policies

There were no significant changes in accounting policies, critical accounting judgements and key sources of estimation uncertainty applied by us in these unaudited condensed consolidated interim financial statements compared to those used in the annual consolidated financial statements as of December 31, 2022.

4. Other non-current assets

As of

June 30,

December 31,

(in thousands of $)

    

2023

    

2022

Non-current restricted cash

$

1,762

$

1,736

Non-current financial assets held at fair value through profit or loss

 

21,715

 

21,715

Non-current financial assets held at fair value through OCI

 

15,756

 

17,443

Total other non-current assets

 

$

39,232

 

$

40,894

Please also refer to note 18 for more information on the financial instruments.

5. Non-current prepaid expense

Non-current prepaid expense is related to prepaid inventory. Please also refer to note 6 for more information on inventory.

8

6. Inventories

As of

June 30,

December 31,

(in thousands of $)

    

2023

    

2022

Raw materials and consumables

 

$

113,128

 

$

126,046

Inventories in process

 

58,806

 

65,016

Finished goods

29,178

37,291

Total inventories

 

$

201,112

 

$

228,353

The cost of inventories, which is recognized as an expense and included in the “cost of sales” on the unaudited condensed consolidated statements of profit or loss, amounted to $42.4 million for the six months ended June 30, 2023 (compared to $6.4 million for the six months ended June 30, 2022).

As a result of the detection of a latent defect in the second quarter of 2023 in drug substance batches produced in 2022 at one of the facilities awaiting approval, the Company has decreased inventory with an amount of $47.3 million. The discovered latent defect comprises an error in the concentration of an excipient in the final formulation, which disqualifies the material for commercial use and causes the Company to write-down its value. The Company has obtained the commitment from the supplier to replace the drug substance from these batches in the coming years, which is reflected in the recognition of a non-current prepaid expense amounting to $47.3 million.

Included in inventory are products which could be used either for commercial activities, or for in-house preclinical and clinical programs, non-reimbursed pre-approval programs and clinical programs carried out by Zai Lab.

7. Trade and other receivables

Trade and other receivables are composed of receivables which are detailed below: