ARGENX SE Files 20-F Annual Report for Fiscal Year Ended December 31, 2023

Ticker: ARGX · Form: 20-F · Filed: Mar 21, 2024 · CIK: 1697862

Sentiment: neutral

Topics: ARGENX SE, 20-F Filing, Annual Report, Biotechnology, Financials

TL;DR

<b>ARGENX SE submitted its 20-F annual report detailing its 2023 fiscal year performance and operations.</b>

AI Summary

ARGENX SE (ARGX) filed a Foreign Annual Report (20-F) with the SEC on March 21, 2024. ARGENX SE filed its 20-F annual report for the fiscal year ending December 31, 2023. The company's principal executive offices are located at Industriepark Zwijnaarde 7, Building C, B-9052 Zwijnaarde, Belgium. ARGENX SE was formerly known as argenx N.V., with a name change effective February 10, 2017. The filing includes details on various stock option exercise price ranges for members during 2023. Currency risks related to SEK, JPY, GBP, DKK, CHF, and CAD were noted for 2023 and 2022.

Why It Matters

For investors and stakeholders tracking ARGENX SE, this filing contains several important signals. This 20-F filing provides a comprehensive overview of ARGENX SE's financial health, operational activities, and strategic direction for the fiscal year 2023, crucial for investors assessing the company's performance and future prospects. The detailed information on stock options and currency risks highlights potential financial exposures and management strategies, offering insights into the company's risk management practices.

Risk Assessment

Risk Level: medium — ARGENX SE shows moderate risk based on this filing. The company operates in the biotechnology sector, which is inherently subject to regulatory hurdles, clinical trial outcomes, and market adoption risks, as indicated by the various stock option exercise price ranges and currency risks mentioned in the filing.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 20-F to understand ARGENX SE's financial position and potential future performance.

Key Numbers

Key Players & Entities

FAQ

When did ARGENX SE file this 20-F?

ARGENX SE filed this Foreign Annual Report (20-F) with the SEC on March 21, 2024.

What is a 20-F filing?

A 20-F is a annual report for foreign private issuers, equivalent to a 10-K but following international reporting standards. This particular 20-F was filed by ARGENX SE (ARGX).

Where can I read the original 20-F filing from ARGENX SE?

You can access the original filing directly on the SEC's EDGAR system. The filing is publicly available and includes all exhibits and attachments submitted by ARGENX SE.

What are the key takeaways from ARGENX SE's 20-F?

ARGENX SE filed this 20-F on March 21, 2024. Key takeaways: ARGENX SE filed its 20-F annual report for the fiscal year ending December 31, 2023.. The company's principal executive offices are located at Industriepark Zwijnaarde 7, Building C, B-9052 Zwijnaarde, Belgium.. ARGENX SE was formerly known as argenx N.V., with a name change effective February 10, 2017..

Is ARGENX SE a risky investment based on this filing?

Based on this 20-F, ARGENX SE presents a moderate-risk profile. The company operates in the biotechnology sector, which is inherently subject to regulatory hurdles, clinical trial outcomes, and market adoption risks, as indicated by the various stock option exercise price ranges and currency risks mentioned in the filing.

What should investors do after reading ARGENX SE's 20-F?

Investors should review the detailed financial statements and risk factors in the 20-F to understand ARGENX SE's financial position and potential future performance. The overall sentiment from this filing is neutral.

Risk Factors

Key Dates

Glossary

20-F
An annual report required for foreign private issuers with securities traded on U.S. stock exchanges. (Provides comprehensive financial and operational information about the company for the fiscal year.)

Filing Stats: 4,485 words · 18 min read · ~15 pages · Grade level 11.8 · Accepted 2024-03-21 06:22:26

Key Financial Figures

Filing Documents

Item 18

Item 17 Item 18 If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No X (APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE YEARS.) Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes No Table of Contents TABLE OF CONTENTS Page PART I ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS 1 ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE 1 ITEM 3. KEY INFORMATION 1 3.A. [RESERVED] 1 3.B. CAPITALIZATION AND INDEBTEDNESS 1 3.C. REASONS FOR THE OFFER AND USE OF PROCEEDS 1 3.D.

RISK FACTORS

RISK FACTORS 1 ITEM 4. INFORMATION ON THE COMPANY 39 4.A. HISTORY AND DEVELOPMENT OF THE COMPANY 39 4.B. BUSINESS OVERVIEW 40 4.C. ORGANIZATIONAL STRUCTURE 104 4.D. PROPERTY, PLANTS AND EQUIPMENT 105 ITEM 4A. UNRESOLVED STAFF COMMENTS 105 ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS 105 5.A. OPERATING RESULTS 106 5.B. LIQUIDITY AND CAPITAL RESOURCES 118 5.C. RESEARCH AND DEVELOPMENT, PATENTS AND LICENSES 121 5.D. TREND INFORMATION 121 5.E CRITICAL ACCOUNTING ESTIMATES 122 ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES 122 6.A. DIRECTORS AND SENIOR MANAGEMENT 122 6.B. COMPENSATION 130 6.C. BOARD PRACTICES 152 6.D. EMPLOYEES 162 6.E. SHARE OWNERSHIP 163 6.F. DISCLOSURE OF A REGISTRANT'S ACTION TO RECOVER ERRONEOUSLY AWARDED COMPENSATION 163 ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS 163 7.A. MAJOR SHAREHOLDERS 163 7.B. RELATED PARTY TRANSACTIONS 166 7.C. INTERESTS OF EXPERTS AND COUNSEL 168 ITEM 8. FINANCIAL INFORMATION 168 8.A. CONSOLIDATED STATEMENTS AND OTHER FINANCIAL INFORMATION 168 8.B. SIGNIFICANT CHANGES 169 ITEM 9. THE OFFER AND LISTING 169 9.A. OFFER AND LISTING DETAILS 169 9.B. PLAN OF DISTRIBUTION 169 9.C. MARKETS 169 9.D. SELLING SHAREHOLDERS 169 9.E.

DILUTION

DILUTION 169 9.F. EXPENSES OF THE ISSUE 170 ITEM 10. ADDITIONAL INFORMATION 170 10.A. SHARE CAPITAL 170 10.B. MEMORANDUM AND ARTICLES OF ASSOCIATION 170 10.C. MATERIAL CONTRACTS 173 10.D. EXCHANGE CONTROLS 173 ii Table of Contents 10.E. TAXATION 174 10.F. DIVIDENDS AND PAYING AGENTS 191 10.G. 191 10.H. DOCUMENTS ON DISPLAY 192 10.I. SUBSIDIARY INFORMATION 192 ITEM 11.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 192 ITEM 12.

DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES

DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES 194 12.A. DEBT SECURITIES 194 12.B. WARRANTS AND RIGHTS 194 12.C. OTHER SECURITIES 194 12.D. AMERICAN DEPOSITARY SHARES 194 PART II 196 ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES 196 ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS 196 ITEM 15.

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 196 ITEM 16. [RESERVED] 197 ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT 197 ITEM 16B. CODE OF ETHICS 197 ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES 198 ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES 199 ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS 199 ITEM 16F. CHANGE IN REGISTRANT'S CERTIFYING ACCOUNTANT 199 ITEM 16G. CORPORATE GOVERNANCE 199 ITEM 16H. MINE SAFETY DISCLOSURE 200 ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 200 ITEM 16J. INSIDER TRADING POLICIES 200 ITEM 16K. CYBERSECURITY 200 PART III 202 ITEM 17.

FINANCIAL STATEMENTS

FINANCIAL STATEMENTS 202 ITEM 18.

FINANCIAL STATEMENTS

FINANCIAL STATEMENTS 202 ITEM 19. EXHIBITS 202 iii Table of Contents Introduction Unless otherwise indicated, "argenx," "argenx SE," "the Company," "our company," "we," "us", "our" our "Group" refer to argenx SE and its consolidated subsidiaries. We own various trademark registrations and applications, and unregistered trademarks, including VYVGART , VYVGART HYTRULO, VYVDURA , ARGENX, ABDEG, NHANCE, SIMPLE ANTIBODY, ARGENXMEDHUB and our corporate logo. Trade names, trademarks and service marks of other companies appearing in this annual report on Form 20-F ( Annual Report ) are the property of their respective holders. Solely for convenience, the trademarks and trade names in this Annual Report may be referred to without the and symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend to use or display other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship, any other companies. VYVGART (efgartigimod alfa) ( VYVGART ) has been approved in the United States ( U.S. ), Japan, Europe, the United Kingdom ( UK ), Israel, mainland China ( Mainland China ) and Canada for the intravenous ( IV ) treatment of generalized myasthenia gravis ( gMG ). We have now commercialized VYVGART in the U.S., several countries in the European Union ( EU ), Japan, Mainland China (through our partner Zai Lab Ltd ( Zai Lab )), Israel (through Medison Pharma Ltd., Medison ) and Canada (all such countries together including Iceland, Norway and Liechtenstein, the VYVGART Approved Countries ). VYVGART subcutaneous ( SC ) (efgartigimod alfa + hyaluronidase qvfc) ( VYVGART SC ) has been approved in the U.S. as VYVGART HYTRULO ( VYVGART HYTRULO ) and in Japan as VYVDURA ( VYVDURA ) for the treatment of gMG. VYVGART SC has also been approved in the EU and the UK for the treatment of gMG. We have now

Forward-looking statements include, but are not limited to, statements about

Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress, development and results of clinical trials of our product candidates, including new indications, alternative dosing regimens and treatment modalities, including statements regarding when results or interim analysis of the clinical trials will be available or made public; the expansion of our business, including the further development of our sales and marketing abilities and our Immunology Innovation Program ( IIP ), and the value of our pipeline; the potential attributes and benefits of our products and product candidates, including new indications, alternative dosing regimens and treatment modalities, and their competitive position with respect to other alternative treatments; our ability to advance product candidates into, and successfully complete, clinical trials; our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that will enroll in our clinical trials; the commercialization of our products and product candidates, including new indications, alternative dosing regimens and treatment modalities, if approved; the anticipated timing of market authorizations of our products, including new indications, alternative dosing regimens and treatment modalities; the anticipated pricing and reimbursement of our products and product candidates, if approved; our plans to have various programs to help patients afford our products, including patient assistance and co-pay coupon programs for eligible patients; the timing or likelihood of regulatory filings and decisions for any products and product candidates, including new indications, alternative dosing regimens and treatment modalities; our ability to establish sales, marketing and distribution capabilities for any of our products and product candidates that achieve regulatory approval; our regulatory strategy and our ability to establish and

IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS

ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS Not applicable.

OFFER STATISTICS AND EXPECTED TIMETABLE

ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE Not applicable.

KEY INFORMATION

ITEM 3. KEY INFORMATION A. [RESERVED] B. CAPITALIZATION AND INDEBTEDNESS Not applicable. C. REASONS FOR THE OFFER AND USE OF PROCEEDS Not applicable. D. RISK FACTORS Our business faces significant risks, including those described below. You should carefully consider all of the information set forth in this Annual Report and in our other filings with the SEC, including the following risk factors which we face and are faced by our industry. Our business, financial condition or results of operations could be materially and adversely affected if any of these risks occurs. These are not the only risks argenx faces. Additional risks and uncertainties not presently known to argenx or that it currently considers immaterial or not specific may also impair its business, results of operation and financial condition. This report also contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially and adversely from those anticipated in these forward-looking statements as a result of certain factors including the risks described below and elsewhere in this Annual Report and our other SEC filings. See " Cautionary Statement with Respect to Forward-Looking Statements ." Risk Factors Related to argenx's Financial Position and Need for Additional Capital We have incurred significant losses since our inception and expect to incur losses for the foreseeable future. We may never achieve or sustain profitability. Since our inception, we have incurred significant operating losses, totaling $2,405 million of cumulative losses. To date we have commercialized VYVGART for the treatment of gMG. We do not currently have any marketing approvals for any other product candidates or VYVGART in other indications. Our losses resulted principally from costs incurred in research and development, preclinical testing and clinical development of our research programs, and from general and administrative costs associated with commercial roll

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