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 October 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  x     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 October 31, 2023, argenx SE (the “Company) issued a press release and investor presentation, 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, 333-258253 and 333-274721).

 

 

EXHIBITS

 

Exhibit   Description
     
99.1   Press Release dated October 31, 2023
     
99.2   Investor Presentation dated October 31, 2023

 

 

 

 

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: October 31, 2023 By:  /s/ Hemamalini (Malini) Moorthy
    Hemamalini (Malini) Moorthy
    General Counsel

 

 

 

 

Exhibit 99.1

 

 

argenx Reports Third Quarter 2023 Financial Results and Provides Business Update

 

-      $329 million in third quarter global net product sales

 

-      On track to submit VYVGART® Hytrulo sBLA for CIDP by year-end 2023

 

-      Results from the ADVANCE-IV study published in The Lancet

 

-      Management to host conference call today at 1:30 pm CET (8:30 am ET)

 

October 31, 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 third quarter 2023 financial results and provided a business update and outlook for the remainder of the year.

 

“We continue to prioritize patient impact with VYVGART and VYVGART Hytrulo, broadening our two gMG products into earlier treatment lines and new geographies. VYVGART has now been used in thousands of patients over multiple treatment years, and its unique clinical profile has built patient trust and physician confidence in the brand,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “There is a significant opportunity before us to transform autoimmunity across multiple indications with VYVGART. Based on the successful ADHERE trial, we are ready to file the sBLA by the end of 2023 to bring our first-in-class FcRn blocker to CIDP patients as quickly as possible. We are also on track with two near-term pivotal readouts and an ambitious plan forward over the coming years as we continue to execute and drive innovation within our FcRn portfolio and across immunology more broadly.”

 

THIRD 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 seven countries or regions (U.S., Japan, EU, UK, Israel, China, Canada) for generalized myasthenia gravis (gMG). VYVGART Hytrulo (subcutaneous (SC) injection) was approved in the U.S. in June 2023. argenx is planning for multi-dimensional expansion to reach more patients with gMG and other severe autoimmune diseases through additional global regulatory approvals.

 

·Generated global net product revenues (inclusive of both VYVGART and VYVGART Hytrulo) of $329 million in the third quarter of 2023

·Health Canada approved VYVGART on September 21, 2023, marking the seventh global approval for gMG

 

 

 

 

 

 

·European Commission (EC) approval of SC efgartigimod for gMG expected in fourth quarter of 2023 following positive recommendation from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)

·Japan approval decision regarding SC efgartigimod for gMG expected by first quarter of 2024

·Japan marketing authorization application (MAA) filed for VYVGART for primary immune thrombocytopenia (ITP); approval decision expected in first quarter of 2024

·U.S. supplemental Biologics License Application (sBLA) for VYVGART Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) on track to be filed by end of 2023

·China approval decision regarding SC efgartigimod for gMG expected by end of 2024 through partnership with Zai Lab

 

Efgartigimod Research and Development

 

argenx is solidifying its leadership in FcRn blockade and demonstrating the broad potential of efgartigimod by advancing its clinical development programs of IgG-mediated autoimmune diseases. By 2025, efgartigimod is expected to be approved, in regulatory review or in development in 15 severe autoimmune diseases

 

·Topline data from ADVANCE-SC (ITP) expected in fourth quarter of 2023; results from ADVANCE-IV study were published in The Lancet in September 2023

·Topline data from ADDRESS (pemphigus) and GO/NO GO decision from BALLAD (bullous pemphigoid) both expected around year-end 2023

·GO/NO GO decision expected from 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 first half of 2024

 

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.

 

·Topline data from Phase 2 ARDA study of empasiprubart (ARGX-117) in multifocal motor neuropathy (MMN) expected in 2024

·Phase 1 study of ARGX-119 ongoing in healthy volunteers; subsequent Phase 1b trial planned to assess early signal detection in patients with congenital myasthenic syndrome (CMS) 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.

 

 

 

 

 

THIRD QUARTER 2023 FINANCIAL RESULTS

 

argenx SE

 

UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS

 

   Three Months Ended
 September 30,
   Nine Months Ended
 September 30,
 
(in thousands of $ except for shares and EPS)  2023   2022   2023   2022 
Product net sales  $329,097   $131,329   $816,432   $227,325 
Collaboration revenue   692    6,652    3,047    9,262 
Other operating income   10,050    8,508    31,275    26,565 
Total operating income  $339,839   $146,489   $850,754   $263,152 
                     
Cost of sales  $(35,999)  $(10,264)  $(78,358)  $(16,646)
Research and development expenses   (191,755)   (236,681)   (553,119)   (515,568)
Selling, general and administrative expenses   (191,930)   (108,181)   (503,079)   (336,845)
Loss from investment in joint venture   (743)   -    (2,623)   - 
Total operating expenses   (420,427)   (355,126)   (1,137,179)   (869,059)
                     
Operating loss  $(80,588)  $(208,637)  $(286,425)  $(605,907)
                     
Financial income  $30,049   $8,007   $67,078   $13,740 
Financial expense   (231)   (785)   (626)   (2,916)
Exchange gains/(losses)   (32,509)   (39,609)   (23,345)   (92,991)
                     
Loss for the period before taxes  $(83,279)  $(241,024)  $(243,318)  $(688,074)
Income tax (expense)/benefit  $10,637   $5,982   $47,437   $17,096 
Loss for the period  $(72,642)  $(235,042)  $(195,881)  $(670,978)
Loss for the year attributable to:                   
Owners of the parent  $(72,642)  $(235,042)  $(195,881)  $(670,978)
Weighted average number of shares outstanding   58,128,233    55,203,655    56,512,254    54,049,119 
Basis and diluted loss per share (in $)   (1.25)   (4.26)   (3.47)   (12.41)
Net increase/(decrease) in cash, cash equivalents and current financial assets compared to year-end 2022 and 2021            $993,035   $48,813 
Cash and cash equivalents and current financial assets at the end of the period            $3,185,583   $2,385,541 

 

 

 

 

 

 

DETAILS OF THE FINANCIAL RESULTS

 

Total operating income for the third quarter and year-to-date in 2023 was $339.8 million and $850.8 million, respectively, compared to $146.5 million and $263.2 million for the same periods in 2022, and mainly consists of:

 

·Product net sales of VYVGART for the three months ended and nine months ended September 30, 2023, were $329.1 million and $816.4 million, compared to $131.3 million and $227.3 million for the same periods in 2022.

·Other operating income for the third quarter and year-to-date in 2023 was $10.1 million and $31.3 million, respectively, compared to $8.5 million, and $26.6 million for the same periods in 2022. The other operating income for the three and nine months ended September 30, 2023, primarily relates to research and development tax incentives and payroll tax rebates. Other income also includes $0.7 million in royalty revenue from VYVGART sales in China.

 

Total operating expenses for the third quarter and year-to-date in 2023 were $420.4 million and $1,137.2 million, respectively, compared to $335.1 million and $869.1 million for the same periods in 2022, and mainly consists of:

 

·Cost of sales for the third quarter and year-to-date in 2023 was $36.0 million and $78.4 million, respectively, compared to $10.3 million and $16.6 million for the same periods in 2022. The cost of sales was recognized with respect to the sale of VYVGART and VYVGART Hytrulo.

·Research and development expenses for the third quarter and year-to-date in 2023 were $191.8 million and $553.1 million, respectively, compared to $236.7 million and $515.6 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 third quarter and year-to-date in 2023 were $191.9 million and $503.1 million, respectively, compared to $108.2 million and $336.8 million for the same periods in 2022. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the commercialization of VYVGART and VYVGART Hytrulo in the U.S., EU and Japan, and personnel expenses.

 

Financial income for the third quarter and year-to-date in 2023 was $30.0 million and $67.1 million, respectively, compared to $8.0 million and $13.7 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 losses for the third quarter and year-to-date in 2023 were $32.5 million and $23.3 million respectively, compared to $39.6 million and $93.0 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 third quarter and year-to-date in 2023 was $10.6 million and $47.4 million of tax benefit, respectively, compared to $6.0 million and $17.1 million of tax benefit for the same periods in 2022. Tax benefit for the nine months ended September 30, 2023, consists of $23.8 million of income tax expense and $71.3 million of deferred tax income, compared to $15.0 million of income tax expense and $32.1 million of deferred tax income for the comparable prior period.

 

 

 

 

  

 

Net loss for the three and nine-month periods ended September 30, 2023, was $72.6 million and $195.9 million, respectively, compared to $235.0 million and $671.0 million over the prior year periods. On a per weighted average share basis, the net loss was $3.47 and $12.41 for the nine months ended September 30, 2023 and 2022, respectively.

 

Cash, cash equivalents and current financial assets totalled $3.2 billion as of September 30, 2023, compared to $2.2 billion as of December 31, 2022. The increase in cash and cash equivalents and current financial assets resulted primarily from the closing of a global offering of shares, including a U.S. offering, which resulted in the receipt of $1.2 billion in net proceeds in July 2023, partially offset by net cash flows used in operating activities.

 

EXPECTED 2024 FINANCIAL CALENDAR

 

·February 29, 2024: FY 2023 financial results and business update

·May 9, 2024: Q1 2024 financial results and business update

·July 25, 2024: Q2 2024 financial results and business update

·October 24, 2024: Q3 2024 financial results and business update

 

CONFERENCE CALL DETAILS

 

The third quarter 2023 financial results and business update will be discussed during a conference call and webcast presentation today at 1:30 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.

 

Belgium 32 800 50 201
France 33 800 943355
Netherlands 31 20 795 1090
United Kingdom 44 800 358 0970
United States 1 888 415 4250
Japan 81 3 4578 9081
Switzerland 41 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, 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, 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 to execute and drive innovation within its FcRn portfolio and across immunology; its plans for multi-dimensional expansion to reach more patients with gMG and other autoimmune diseases through additional global regulatory approvals; advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the (1) expected EC approval of SC efgartigimod for gMG in the fourth quarter of 2023, (2) expected approval decision regarding SC efgartigimod for gMG in Japan by the first quarter of 2024, (3) expected MAA for VYVGART for primary ITP approval decision in Japan in the first quarter of 2024, (4) expected filing of the sBLA for VYVGART Hytrulo in CIDP by the end of 2023, (5) expected approval decision regarding SC efgartigimod for gMG in China by end of 2024 through its partnership with Zai Lab; (6) expected topline data from ITP in the fourth quarter of 2023, (7) expected topline data from ADDRESS and the GO/NO GO decision from BALLAD around year-end 2023, (8) expected GO/NO GO decision from ALKIVIA in the second half of 2024, (9) expected topline dtaa from ALPHA in the first quarter of 2024 and RHO in the first half of 2024, (10) expected topline data from Phase 2 ARDA study of ARGX-117 in MMN in 2024, (11) planned Phase 1b trial to assess early signal detection in patients with CMS and ALS and (12) planned nomination of a new pipeline candidate in 2023; continued investment in its Immunology Innovation Program to foster a robust innovation ecosystem and drive early-stage pipeline growth; and 2023 business and financial outlook and related plans, 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 collaborations 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.

 

 

 

Exhibit 99.2

 

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Third Quarter 2023 Financial Results and Business Update October 31, 2023

Forward Looking Statements This presentation has been prepared by argenx se (“argenx” or the “company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or the company or any director, employee, agent, or adviser of the company. This presentation does not purport to be all-inclusive or to contain all of the information you may desire. Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the company’s own internal estimates and research. While argenx believes these third-party studies, publications, surveys and other data to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent source has evaluated the reasonableness or accuracy of argenx’s internal estimates or research and no reliance should be made on any information or statements made in this presentation relating to or based on such internal estimates and research. The contents of this presentation 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 launch of VYVGART for generalized myasthenia gravis (gMG) and expansion strategy to reach more patients with VYVGART through additional regulatory approvals; the safety profile and efficacy of VYVGART, the advancement of ARGX-117 and ARGX-119 to clinical proof-of-concept; the planned SC approval and June 20th PDUFA date; its ability to transform gMG treatment for patients; its anticipated clinical data readouts, including in chronic inflammatory demyelinating polyneuropathy (CIDP), immune thrombocytopenia (ITP), pemphigus vulgaris (PV), postural orthostatic tachycardia syndrome (POTS) and multifocal motor neuropathy (MMN); the therapeutic potential and patient treatment experience of its product candidates, its strategy to expand access to treatments through engagement with physicians, payors, and patient communities; expected filing of the sBLA for VYVGART Hytrulo in CIDP by the end of 2023; pending regulatory reviews of SC efgartigimod for gMG in China, Canada, Europe, and Japan; expectations about its pipeline progress; its collaborations and their potential benefits; the intended results of its strategy and its collaboration partners', advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals; and its 2023 business and financial outlook and related plans. 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 effects of the COVID-19 pandemic, inflation and deflation and the corresponding fluctuations in interest rates; 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 collaborations 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. This presentation contains trademarks, trade names and service marks of other companies, which are the property of their respective owners. 2

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Driving Sustained Growth Across the Business Consistent Execution + Perpetual Innovation Reaching More Patients Geographic Expansion Pioneer FcRn Class of Medicines Broaden Immunology Pipeline Double-digit growth quarter over quarter Approval in Canada Filing of CIDP sBLA by EOY GO decision in MMN 3

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What FcRn Leadership Looks Like Today 4 20 presentations demonstrating neuromuscular leadership Consistent Efficacy Favorable Safety Deep FcRn Expertise MG-ADL, QMG, QoL, MSE TEAEs mild to moderate Unique target modulation >1,000 Patient Years of safety data across indications Real-world experience in ~6,000 patients

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5 q2w = every other week Adult Chronic or Persistent ITP patients 2 weeks screening Mean platelet count <30x109/L Stable concomitant ITP therapy allowed Stratification: splenectomy, concomitant ITP therapy 0 Visit Fixed weekly dosing Weekly or q2w dosing based on platelet count thresholds Week 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Patients randomized 2:1 to receive VYVGART Hytrulo or placebo (24 weeks) Fixed weekly or q2w dosing based on week 15 Primary endpoint: Sustained platelet count (≥50×109/L) in ≥4/6 visits between weeks 19 and 24 Stringent endpoint in line with regulatory feedback, addressing platelet count variability Secondary and exploratory endpoints center around extent of disease control to illustrate real-world viability Topline data expected 4Q 2023 ITP ADVANCE-SC Trial Primary Endpoint

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1-3 weeks Screening Efgartigimod weekly SC Placebo weekly SC Pemphigus vulgaris (PV) and foliaceus (PF) Moderate-to-Severe Disease (PDAI activity score ≥ 15) Newly Diagnosed and Relapsing Prednisone starting dose 0.5 mg/kg/day with ability to adjust Active tapering to start from sustained CR or EoC Concomitant prednisone Randomization (2x1) 30 weeks Primary endpoint is proportion of PV patients achieving CRmin* within 30 weeks N=222 (PV and PF) PF patients capped Followed by Open Label Extension study CR=complete clinical remission; CRmin=complete remission on minimal therapy; EoC=end of consolidation; SC=subcutaneous. 6 Pemphigus ADDRESS Trial: Topline data expected around YE 2023

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7 Steady Cadence of Upcoming Data Readouts ITP-SC: Topline data expected in 4Q 2023 Pemphigus: Topline data expected around year-end 2023 Bullous Pemphigoid (BP): GO/NO GO decision expected around year-end 2023 Post-COVID Postural Orthostatic Tachycardia Syndrome (PC-POTS): Topline data expected in 1Q 2024 Sjogren’s Syndrome: Topline data expected in first half 2024 Myositis: GO/NO GO decision expected in second half of 2024 Multifocal Motor Neuropathy (MMN): Topline data from Phase 2 (empasiprubart) expected in 2024 clinical

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Q3 2023 Product Net Sales of $329M Third Quarter 2023 Finance Summary (in millions of $) Q3 2023 Q2 2023 QoQ % Growth US 280 244 +15% Japan 15 13 +15% EMEA 26 12 +128% China 7 - n/a Total 329 269 +22% Product Net Sales by Region 21 75 131 173 218 269 329 2022 Q1 2022 Q2 2023 Q2 2023 Q1 2022 Q3 2022 Q4 2023 Q3 +54 (+257%) +56 (+75%) +42 (+32%) +45 (+26%) +51 (+23%) +60 (+22%) Three months ended Nine months ended (in millions of $) September 30 September 30 2023 2022 2023 2022 Product net sales 329 131 816 227 Other & collaboration rev 11 15 34 36 Total operating income 340 146 851 263 Total operating expenses (420) (355) (1,137) (869) Operating loss for the period (81) (209) (286) (606) Financial inc / (exp) (3) (32) 43 (82) Loss before tax (83) (241) (243) (688) Tax 11 6 47 17 Loss for the period (73) (235) (196) (671) Summary P/L Cash reflects cash, cash equivalents and current financial assets. Total Operating Expenses include Cost of Sales, R&D, SG&A and Loss from investment in joint venture. Financial income / (expenses) includes financial income / (expenses) and exchange gains / (losses). Table in $’m and impacted by rounding. Ended third quarter 2023 with cash of $3.2B 8 Table in $’m and impacted by rounding.

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9 Geographies Indications Presentations Pre-filled syringe CIDP BP Pemphigus ITP gMG Myositis US Japan EMEA UK China Future geographies Future presentations Multi-dimensional Expansion to Reach Autoimmune Patients Globally 15 indications by 2025 POTS Sjogren’s Canada

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10 Optimizing Core Launch Strategies Reaching Broader gMG Population Continued shift into earlier lines First Hytrulo policies published Driving brand loyalty among prescribers IN $ COMBINED NET 816 VYVGART M & HYTRULO SALES YTD Hytrulo contributing to expansion Hytrulo launch driven by VYVGART-naïve patients Policies in line with IV 88% of key target prescribers reached since launch

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11 Today 1 Innovating on the Patient Experience Future product presentations providing flexibility in HOW and WHERE patients are treated Single 30-90 second Injection Effective Safe Future 2 Second Generation Future Generations Exclusive collaborations with HALO and Elektrofi on formulation Exploring autoinjector and additional formats to optimize patient experience More details early next year 3 Exploring autoinjector and additional formats to optimize patient experience Pre-filled Syringe (PFS) Ongoing development in BE/HF studies Aim to support self-administration1 Future Generations Exclusive collaboration Collaboration on formulation Note: Self administration expected on label in Europe and Japan

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12 Reaching gMG Patients Across the Globe APPROVALS COMPLETE U.S. JAPAN EUROPE UK ISRAEL CHINA CANADA DEC 2021 JAN 2022 SEPT 2022 MAR 2023 APRIL 2023 JUNE 2023 SEPT 2023 APPROVALS COMPLETE U.S. JUNE 2023 APPROVALS PENDING JAPAN EUROPE CHINA BY Q1 2024 Q4 2023 2024

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Bringing Hope to Patients of New Treatment Option Advancing Hytrulo in CIDP I was the type of woman that would run first thing in the morning before work, and then CIDP hit, and it was like hitting the wall at a hundred miles an hour. Crystal Living With CIDP Largest Global CIDP Trial New standard set for innovative trial design Unlocking New Disease Biology Insights IgG shown to play significant role in underlying biology of CIDP Potential new treatment modality First Innovation in 30+ Years 13 99% rollover into OLE On track to file sBLA in 2023 with launch targeted in 2024

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14 Our mission continues… Humility Innovation Excellence Co-Creation Empowerment


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