argenx SE ADR 2025年年度报告和过渡报告

TABLE OF CONTENTS A.[RESERVED]B.CAPITALIZATION AND INDEBTEDNESSC.REASONS FOR THE OFFER AND USE OF PROCEEDSD.RISK FACTORS ITEM4.INFORMATION ON THE COMPANYA.HISTORY AND DEVELOPMENT OF THE COMPANY B.BUSINESS OVERVIEWC.ORGANIZATIONAL STRUCTURED.PROPERTY, PLANTS AND EQUIPMENT A.OPERATING RESULTSB.LIQUIDITY AND CAPITAL RESOURCESC.RESEARCH AND DEVELOPMENT, PATENTS AND LICENSESD.TREND INFORMATIONE.CRITICAL ACCOUNTING ESTIMATES F.DISCLOSURE OF A REGISTRANT’S ACTION TO RECOVER ERRONEOUSLY AWARDEDCOMPENSATION146 ITEM7.MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS146 A.MAJOR SHAREHOLDERS146B.RELATED PARTY TRANSACTIONS149C.INTERESTS OF EXPERTS AND COUNSEL150 A.OFFER AND LISTING DETAILSC.MARKETSB.PLAN OF DISTRIBUTIOND.SELLING SHAREHOLDERSE.DILUTIONF.EXPENSES OF THE ISSUE ITEM10.ADDITIONAL INFORMATION A.SHARE CAPITAL151B.MEMORANDUM AND ARTICLES OF ASSOCIATION151C.MATERIAL CONTRACTS154D.EXCHANGE CONTROLS154 E.TAXATION154F.DIVIDENDS AND PAYING AGENTS169G.STATEMENT BY EXPERTS169H.DOCUMENTS ON DISPLAY169I.SUBSIDIARY INFORMATION170ITEM11.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK170ITEM12.DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES171A.DEBT SECURITIES171B.WARRANTS AND RIGHTS171C.OTHER SECURITIES171D.AMERICAN DEPOSITARY SHARES171PARTII173ITEM13.DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES173ITEM14.MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USEOF PROCEEDS173ITEM15.CONTROLS AND PROCEDURES173A.DISCLOSURE CONTROLS AND PROCEDURES173B.MANAGEMENT’S ANNUAL REPORT ON INTERNAL CONTROL OVER FINANCIALREPORTING173C.ATTESTATION OF THE REGISTERED PUBLIC ACCOUNTING FIRM174D.CHANGES IN INTERNAL CONTROL OVER FINANCIAL REPORTING174ITEM16.[RESERVED]174ITEM16A.AUDIT COMMITTEE FINANCIAL EXPERT174ITEM16B.CODE OF ETHICS174ITEM16C.PRINCIPAL ACCOUNTANT FEES AND SERVICES174ITEM16D.EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES175ITEM16E.PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATEDPURCHASERS175ITEM16F.CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT175ITEM16G.CORPORATE GOVERNANCE176ITEM16H.MINE SAFETY DISCLOSURE176ITEM16I.DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENTINSPECTIONS176ITEM16J.INSIDER TRADING POLICIES176ITEM16K.CYBERSECURITY177PARTIII178ITEM17.FINANCIAL STATEMENTS178ITEM18.FINANCIAL STATEMENTS178ITEM19.EXHIBITS178 Introduction Unless otherwise indicated, “argenx,” “argenx SE,” “the Company,” “our company,” “we,” “us”, “our” our “Group”refer toargenx SEand its consolidated subsidiaries. We own various trademark registrations and applications, and unregistered trademarks, including but not limited toVYVGART®, VYVGART HYTRULO™, VYVDURA®, ARGENX™, ABDEG™, NHANCE™, SIMPLEANTIBODY™, ARGENXMEDHUB™, MG UNITED™, SHINING THROUGH CIDP™ and our corporate logo.Trade names, trademarks and service marks of other companies appearing in this Annual Report are the property of theirrespective holders. Solely for convenience, the trademarks and trade names in this Annual Report may be referred towithout the®and ™ symbols, but such references should not be construed as any indicator that their respective ownerswill not assert, to the fullest extent under applicable law, their rights thereto. We do not intend to use or display othercompanies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship, any othercompanies. VYVGART®(efgartigimod alfa) (VYVGART) has been approved in the U.S., Japan, the European Union (the EU), theUnited Kingdom (UK), Switzerland, Israel, mainland China (Mainland China), Canada, South Korea and United ArabEmirates for the intravenous treatment of generalized myasthenia gravis (gMG). We have now commercializedVYVGART in the U.S., several countries in the EU, Japan, Mainland China (through our partner Zai Lab Ltd (Zai Lab)),Israel (through our Medison Pharma Ltd. (Medison)) and Canada. VYVGART is now also approved and launched in Japan for the treatment of ITP. VYVGART subcutaneous (SC) (efgartigimod alfa + hyaluronidase qvfc) (VYVGART SC) has been approved in theU.S. and China as VYVGART HYTRULO™ (VYVGART HYTRULO), in Japan as VYVDURA®(VYVDURA) and inthe EU and the UK as VYVGART for the treatment of gMG. VYVGART SC has also been approved in Israel for thetreatment of gMG. We have now commercialized VYVGART SC for gMG in the U.S. and China (as VYVGARTHYTRULO), in Japan (as VYVDURA) and in several countries in the EU (as VYVGART). Pricing and reimbursementdiscussions for VYVGART SC remain ongoing in multiple other countries, including more countries in the EU. VYVGART SC has now also been approved in the U.S., China and Japan for the treatment of chronic inflammatorydemyelinating polyneuropathy (CIDP). We have now commercialized VYVGART SC for CIDP in the U.S. and China(as VYVGART HYTRULO) and in Japan (as VYVDURA). For both VYVGART and VYVGART SC, we are aiming for further approvals and we are working to expandcommercialization in other jurisdictions. Unless otherwise specified, references in this Annual Rep