Annual Report 2023

Annual Report 2023

About this report

2023 Annual Report including the Annual Financial Statements for the year ended December 31, 2023

This Annual Report is filed with the Dutch Authority for the Financial Markets (Stichting Autoriteit Financiële Markten, AFM). The following main items included in our annual report on Form 20-F for the year ended December 31, 2023 (2023 20-F) filed with the United States Securities and Exchange Commission (SEC) on or about the date of this Annual Report have not been included in this Annual Report:

  • Form 20-F cover page;
  • Item 7 – Major Shareholders and Related Party Transactions;
  • Item 10E – Taxation;
  • Item 16E – Purchases of Equity Securities by the Issuer and Affiliated Purchasers
  • Item 16G – Corporate Governance;
  • Report of Independent Registered Public Accounting Firm in respect of Internal Control over Financial Reporting for the SEC filing;
  • Report of Independent Registered Public Accounting Firm in respect of the PCAOB audits of the 2023 financial statements for the SEC filing;
  • Exhibits; and
  • Signatures.

The following main sections of our Annual Report have not been included in our 2023 20-F:

  • Shareholder Letter;
  • Outlook 2023;
  • Statement of the Board of Directors;
  • Risk Appetite and Control;
  • Share Classes and Principal Shareholders;
  • Non-Financial Information;
  • The Company Financial Statements under section Financial Statements (prepared pursuant to Dutch law);
  • Independent auditor’s report - Report on the audit of the financial statements 2023 included in the Annual Report with respect to the AFM Filing; and
  • Glossary.

Certain defined terms

argenx SE (herein argenx or the Company and, together with its subsidiaries, the Group, we or us) is a European public company (Societas Europaea) incorporated under the laws of the Netherlands with its statutory seat in Rotterdam, the Netherlands. It is publicly listed in Belgium and the United States of America (the U.S.). The applicable regulations with respect to public information and protection of investors, as well as the commitments we make to securities and market authorities, are described in this Annual Report.

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 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 U.S., Japan, Europe, the United Kingdom (UK), Israel, mainland China (Mainland China) and Canada for the intravenous treatment of generalized myasthenia gravis (gMG). We have now commercialized VYVGART 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 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 commercialized VYVGART SC in the U.S. (as VYVGART HYTRULO) and in Germany. Pricing and reimbursement discussions for VYVGART SC remain ongoing in multiple other countries, including in the EU and Japan (as VYVDURA).

For both VYVGART and VYVGART SC, we are aiming for further approvals and we are working to expand commercialization in other jurisdictions.

Where not specified, references in this Annual Report to VYVGART should be read as references to VYVGART and/or VYVGART SC, including VYVGART HYTRULO in relation to the U.S. and VYVDURA in relation to Japan, depending on the context.

Basis of preparation of our audited consolidated financial statements

Our audited consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS), as issued by the International Accounting Standards Board (IASB) and adopted by the European Union (EU). Accordingly, our consolidated financial statements are presented in this Annual Report in U.S. dollars. All references in this Annual Report to “$,” “US$,” “U.S.$,” “U.S. dollars,” “dollars” and “USD” mean U.S. dollars and all references to “€,” “EUR,” and “euros” mean euros, unless otherwise noted. Throughout this Annual Report, references to ADSs mean American depositary shares (ADSs) or ordinary shares represented by ADSs, as the case may be.

Forward-looking Statements

This Annual Report contains certain forward-looking statements. A forward-looking statement is any statement that does not relate to historical facts or events or to facts or events as of the date of this Annual Report or that are derived from our management’s beliefs and assumptions based on information currently available to our management. Forward-looking statements are generally identified by the use of forward-looking words, such as “anticipate”, “aspire”, “believe”, “can”, “continue”, “could”, “estimate”, “expect”, “hope”, “intend”, “is designed to”, “look forward to”, “may”, “might”, “objective”, “plan”, “potential”, “project”, “predict”, “seek”, “should”, “target”, “will” or other variations or the negative of such terms, or by discussion of strategy, although not all forward-looking statements contain these identifying words. These statements relate to our future results of operations and financial positions, prospects, developments, business strategies, plans and our objectives for future operations, results of clinical trials and regulatory approvals, and are based on analyses or forecasts of future developments and estimates of amounts not yet determinable. These forward-looking statements represent the view of management only as of the date of this Annual Report, and we disclaim any obligation to update forward-looking statements, except as may be otherwise required by law. The forward-looking statements in this Annual Report involve known and unknown risks, uncertainties and other factors that could cause our actual future results, performance and achievements to differ materially from those forecasted or suggested herein.

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 maintain manufacturing arrangements for our products and product candidates;
  • the scope and duration of protection, including any exclusivity period, we are able to establish and maintain for intellectual property rights covering our products and product candidates, platform and technology, including our intention to seek patent term extensions where available;
  • our estimates regarding expenses, future revenues, cash burn, capital requirements and our needs for additional financing;
  • our financial performance, including potential volatility in the price of our ordinary shares and ADSs;
  • the rate and degree of market acceptance of our products and product candidates, if approved;
  • the potential benefits of our current collaborations, including the possibility to access partner technology platforms or capabilities;
  • our plans and ability to enter into collaborations for additional programs or product candidates;
  • our plans and ability to enter into new distribution partnerships;
  • the impact of government laws and regulations on our business;
  • our expectations with respect to the timing and amount of any dividends;
  • our plans regarding our supply chain, including our reliance on third parties, including CMOs; and
  • the implementation of our diversity, equity and inclusion policy, including our goal to further improve diversity on our board of directors (Board of Directors).

These include changes in general economic and business conditions. You should refer to section “Risk Factors” of this Annual Report for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Annual Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

You should read this Annual Report and the documents that we reference in this Annual Report and have filed as exhibits to the Annual Report completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

Information regarding market and industry statistics contained in this Annual Report is included based on information available to us that we believe is accurate. Forecasts and other forward-looking information obtained from this available information is subject to the same qualifications and the additional uncertainties accompanying any estimates of future market size, revenue and market acceptance of products and services.

In addition, statements that include “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Annual Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements.