argx-20241231

Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 20-F

(Mark One)

☐REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES

EXCHANGE ACT OF 1934

☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE

ACT OF 1934

For the fiscal year ended December 31, 2024

☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES

EXCHANGE ACT OF 1934

For the transition period from __________ to __________

☐SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES

EXCHANGE ACT OF 1934

Date of event requiring this shell company report __________

Commission file number 001-38097

ARGENX SE

(Exact name of registrant as specified in its charter and translation of Registrant’s name into English)

The Netherlands

(Jurisdiction of incorporation or organization)

Laarderhoogtweg 25

1101 EB, Amsterdam, The Netherlands

(Address of principal executive offices)

Tim Van Hauwermeiren

argenx BV

Industriepark Zwijnaarde 7,

Building C

9052 Zwijnaarde(Ghent)

Belgium

+31(0)10 70 38 441

TVanHauwermeiren@argenx.com

(Name, telephone, e-mail and/or facsimile number and address of company contact person)

Securities registered or to be registered pursuant to Section 12(b) of the Act:

Title of each class:

Trading

Name of each exchange on which registered:

Symbol:

American Depositary Shares, each representing one ordinary share with a nominal value of €0.10 per share

ARGX

Nasdaq Global Select Market

Ordinary shares with a nominal value of €0.10 per share*

Nasdaq Global Select Market*

* Not for trading, but only in connection with the registration of the American Depositary Shares.

Securities registered or to be registered pursuant to Section 12(g) of the Act: None.

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None.

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report:

As of December 31, 2024

60,760,957 ordinary shares were outstanding, including ordinary shares represented by American Depositary Shares.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act

Yes ☒ No ☐

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

Yes ☐ No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such

shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter)

during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See the definitions of “large accelerated filer,”

“accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☒

Accelerated filer ☐

Non-accelerated filer ☐

Emerging growth company ☐

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for

complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. ☐

† The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section

404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☒

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to

previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers

during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

International Financial Reporting Standards as issued

U.S. GAAP ☐

by the International Accounting Standards Board ☒

Other ☐

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.

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 ☒

(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 ☐

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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 but not limited to

VYVGART®, VYVGART HYTRULO™, VYVDURA®, ARGENX™, ABDEG™, NHANCE™, SIMPLE

ANTIBODY™, 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 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, the European Union (the EU), the

United Kingdom (UK), Switzerland, Israel, mainland China (Mainland China), Canada, South Korea and United Arab

Emirates 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 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 the

U.S. and China as VYVGART HYTRULO™ (VYVGART HYTRULO), in Japan as VYVDURA® (VYVDURA) and in

the EU and the UK as VYVGART for the treatment of gMG. VYVGART SC has also been approved in Israel for the

treatment of gMG. We have now commercialized VYVGART SC for gMG in the U.S. and China (as VYVGART

HYTRULO), in Japan (as VYVDURA) and in several countries in the EU (as VYVGART). Pricing and reimbursement

discussions 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 inflammatory

demyelinating 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 expand

commercialization in other jurisdictions.

Unless otherwise 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 China, VYVGART in relation to

the EU and the UK and VYVDURA in relation to Japan, depending on the context.

Our consolidated financial statements are prepared in accordance with the IFRS® Accounting Standards (IFRS) as issued

by the International Accounting Standards Board (IASB).

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.

Cautionary Statement with Respect to 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”, “entail”, “hope”, “intend”, “is designed to”, “look forward

to”, “may”, “might”, “objective”, “plan”, “potential”, “pursue”, “project”, “predict”, “seek”, “should”, “target”, “will” or

other or comparable variations or the negative of such terms, or by discussion of strategy, plans, objectives, goals, future

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events or intentions, although not all forward-looking statements contain these identifying words. These statements relate

to our future results of operations and financial positions, prospects, developments, growth, 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 expressly disclaim any obligation or

undertaking to update, review or revise forward-looking statements (whether as a result of new information, future

developments or otherwise), except as may be otherwise required by applicable law. The forward-looking statements in

this Annual Report involve known and unknown risks, future events, assumptions, uncertainties and other factors that

could cause our actual future results of operations and financial positions, prospects, developments, growth, business

strategies, plans and our objectives for future operations, results of clinical trials and regulatory approvals 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, treatment modalities, and methods of administration, 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 IIP, and

the value of our pipeline;

•the potential attributes, benefits, and side effects 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 demand and commercialization of our products and product candidates, including new indications, alternative

dosing regimens, treatment modalities, and methods of administration, if approved;

•the anticipated timing or likelihood of market or regulatory decisions relating to or of our products, including new

indications, alternative dosing regimens, treatment modalities, and methods of administration;

•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;

•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 flow, capital requirements and our needs for additional

financing;

•our expectation that we will benefit from the Belgian innovation income deduction;

•our financial performance, including potential volatility in the price of our ordinary shares and ADSs;

•the competition we face in our drug discovery, development, and commercialization efforts;

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•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 or maintain current collaborations for additional programs or product candidates;

•our plans and ability to enter into or maintain current new distribution partnerships;

•our long-term growth strategy to develop and market additional products and product candidates, including

efgartigimod for new indications, empasibrubart and ARGX-119;

•the impact of government laws and regulations on our business;

•our expectations with respect to the timing and amount of any dividends (if any);

•our plans regarding our supply chain, including our reliance on third parties, including contract manufacturing

organizations (CMOs); and

•our business strategies, plans, projects, goals and targets and the timing, outcomes and benefits thereof.

These include changes in general economic and business conditions. You should refer to ”Item 3.D — 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.

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Summary Risk Factors

Our ability to implement our business strategy is subject to numerous risks that you should be aware of before making an

investment decision. These risks are described more fully below. These risks include, among others:

•The commercial success of our products and product candidates, including in new indications or methods of

administration, will depend on the degree of market acceptance.

•We face significant competition for our drug discovery and development efforts.

•We will face significant challenges in successfully commercializing our products and additional product candidates

after they are launched.

•Our products and product candidates for which we have obtained or intend to seek approval as biological products,

including for new indications, may face biosimilar competition.

•Enacted and future legislation could impact demand for our products which could impact our business and future

results of operations.

•We are subject to government pricing laws, regulation and enforcement. These laws affect the prices we may charge

the government for our products and the reimbursement our customers may obtain from the government. Our failure

to comply with these laws could harm our results, operations and/or financial conditions.

•We may not obtain or maintain adequate pricing and coverage or reimbursement status for our products and product

candidates.

•If we fail to obtain orphan drug designation or we do not have valid and enforceable patents covering our products

and their uses and product candidates and fail to obtain and/or maintain orphan drug exclusivity for our products or

product candidates, our competitors may be able to sell products to treat the same conditions and our revenue may be

reduced.

•Failure to successfully identify, select and develop our products in other indications, or additional products or product

candidates could impair our ability to grow.

•Failure to successfully develop or obtain marketing approval for our products and product candidates could

negatively impact our business.

•Certain of our clinical trials have not succeeded, and may in the future also not succeed, and even if they succeed, we

may not obtain regulatory approval for our products or product candidates or regulatory approval may be delayed.

•If we decide to pursue accelerated approval for any of our product candidates, it may not lead to faster development

or regulatory review or approval and we may still need to conduct additional clinical trials, which could increase the

expense of obtaining, if at all, necessary marketing approvals.

•Our products and product candidates may have serious adverse, undesirable or unacceptable side effects, and we or

others may identify undesirable or unacceptable side effects caused by any of our products or product candidates

before and after they have received marketing approval.

•If our target patient population is smaller than expected, we are unable to successfully enroll and retain patients in our

clinical trials, or experience significant delays in doing so, we may not realize the full commercial potential of any

products or product candidates.

•We rely, and expect to continue to rely, on third parties to conduct some of our research activities and clinical trials

and for parts of the development and commercialization of our existing and future research programs, products and

product candidates. If our relationships with such third parties are not successful, our business may be adversely

affected.

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•Disruptions caused by our reliance on third parties for our manufacturing process may delay or disrupt our business,

product development and commercialization efforts.

•Accuracy and timing of our financial reporting is partially dependent on information received from third-party

partners, which we do not control.

•We and our third-party manufacturers and suppliers may become exposed to liability, fines, penalties or other

sanctions and substantial expenses in connection with environmental compliance or remediation activities.

•We are subject to healthcare laws, regulation and potential enforcement. The failure to comply with these laws could

harm our results, operations and/or financial conditions.

•Our performance tracked by our Environmental, Social and Governance metrics is subject to risks and the outcomes

may not achieve the anticipated benefits or align with new regulations and stakeholders’ expectations.

•We expect to increase our expenses for the foreseeable future, and we may not be able to raise additional capital, be

profitable or sustain net profitability in the future in order to fund our operations.

•We may become exposed to costly and damaging liability claims and other litigation.

•Our business and operations could suffer in the event of system failures or unauthorized or inappropriate use of or

access to our systems.

•We are highly dependent on public perception of our products.

•We may be unable to adequately maintain, enforce or protect our intellectual property rights in products, product

candidates and platform technologies which could adversely affect our ability to maximize the value for patients in

our marketed products and product candidates.

•Intellectual property litigation could lead to substantial resource diversion or issued patents could be found invalid,

not infringed, or unenforceable if challenged in the applicable patent office or court.

•Our future growth and ability to compete depends on maintaining our culture, retaining our key personnel and

recruiting additional qualified personnel.

•Global geo- and socio-political threats and macro-economic uncertainty and other unforeseen political crises could

materially and adversely affect our business and financial performance.

•Holders of our ADSs have fewer rights than our ordinary shareholders.

•The price of our ADSs may be volatile and may fluctuate due to factors beyond our control. An active public trading

market may not be sustained.

•Claims of U.S. civil liabilities may not be enforceable against us or the members of our Senior Management Team

and our Board of Directors.

•As a foreign private issuer, we are exempt from various rules and regulations that a U.S. domestic public company

would be required to follow, including those requirements under U.S. securities laws and Nasdaq listing standards.

•We may lose our foreign private issuer status which would then require us to comply with the Exchange Act’s

domestic reporting regime and cause us to incur significant legal, accounting and other expenses.

•If we were to be classified as a passive foreign investment company for U.S. federal income tax purposes, this could

result in adverse U.S. tax consequences to certain U.S. holders.


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PART I

ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS

Not applicable.

ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE

Not applicable.

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 Commercialization of argenx’s Products and Product Candidates, Including for New

Indications

The commercial success of our products and product candidates, including in new indications or methods of

administration, will depend on the degree of market acceptance.

Our products and product candidates, including for new indications or methods of administration, if and when approved

and available on the market, may never achieve an adequate level of acceptance by physicians, patients, the medical

community, or healthcare payors for us to be profitable or sustain net profitability in the future. This will depend on a

number of factors, many of which are beyond our control, including, but not limited to:

•consumer perceptions or publicity regarding our business or the efficacy, safety and quality of the products and

product candidates in our profile, our clinical trials for new indications, or any similar products distributed by other

companies, and the prevalence and severity of any adverse effects discovered before or after marketing approval has

been received;

•approval may be for indications, dosage and methods of administration or patient populations that are not as broad as

intended or desired;

•changes in the standard of care for the targeted indications for any product and product candidate;

•relative availability, cost, and convenience of alternative approved therapies;

•labeling may require significant use or distribution restrictions or safety warnings;


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•acceptance by physicians, public health bodies, patients and healthcare payors of each product as safe, effective and

cost-effective; and

•patients continued commitment required to receive periodic in-center infusions.

In addition, because we are developing our products and product candidates for the treatment of different indications,

negative results in a clinical trial evaluating the efficacy and safety of a product or product candidate for one indication,

including by one of our competitors, could negatively impact the perception of the efficacy and safety of such product or

product candidate in a different indication, which could have an adverse effect on our reputation, commercialization

efforts and financial condition.

Moreover, efforts to educate the medical community and third-party payors on the benefits of our products and product

candidates may require significant resources and may never be successful. If our product candidates or methods of use of

existing products or new indications fail to gain market acceptance, this will have a material adverse impact on our

ability to generate revenues. Even if some products achieve market acceptance, they may not be able to retain market

acceptance and/or the market may prove not to be large enough to allow us to generate significant revenues.

We face significant competition for our drug discovery and development efforts.

The market for pharmaceutical products is highly competitive and characterized by rapidly growing understanding of

disease biology, quickly changing technologies, strong intellectual property barriers to entry, and a multitude of

companies involved in the creation, development, and commercialization of novel therapeutics. Many of these

companies are highly sophisticated and often strategically collaborate with each other.

Competition in the autoimmune field is intense and involves multiple mAbs, other biologics and small molecules either

already marketed or in development by many different companies including, but not limited to, large pharmaceutical

companies such as AbbVie, Inc. (AbbVie), Amgen, Inc. , Biogen Inc. , GlaxoSmithKline plc , F. Hoffman-La Roche AG

(Roche) and Janssen Pharmaceuticals, Inc. now part of Johnson & Johnson Innovation, Inc. (Johnson & Johnson). In

addition, these and other pharmaceutical companies have mAbs or other biologics in clinical development for the

treatment of autoimmune diseases.

Currently, our commercial revenue is generated by VYVGART and VYVGART SC in gMG, CIDP and ITP (Japan

only). We face and expect to continue to face intense competition from other biopharmaceutical companies, who have

launched or are developing products for the treatment of gMG and/or CIDP and other autoimmune diseases, including

products that are in the same class as VYVGART, as well as products that are similar to some of our product candidates.

Competition for other (potential) future indications is also fierce, with significant development in almost all of the

indications we are currently developing or planning to develop for our product or product candidates. For example, we

are aware of several neonatal Fc receptor (FcRn) inhibitors that are in clinical development and one FcRn inhibitor,

Rystiggo (rozanolixizumab-noli), which was approved in June 2023. We are also aware that AstraZeneca plc is selling

Soliris and Ultomiris for the treatment of adult patients with gMG who are AChR-AB+ and that UCB is selling Rystiggo

for the treatment of adult patients with gMG who are AchR-AB+ or MuSK-AB+ and Zilbrysq for the treatment of adult

patients with gMG who are AchR-AB+. Roche, Novartis AG, CSL Behring, Grifols, S.A., Curavac, Inc., Takeda

Pharmaceutical Co Ltd, RemeGen Co, Immunovant, Inc., Cartesian Therapeutics, Inc., Horizon Therapeutics plc,

Regeneron Pharmaceuticals, Inc., Alnylam Pharmaceuticals, Inc., Sanofi S.A. and Johnson & Johnson, among others, are

developing drugs that may have utility for the treatment of myasthenia gravis (MG) and/or CIDP. Any negative side

effects or safety concerns from one of our competitors’ products may adversely affect our business.

Competitive product launches may erode future sales of our products, including our existing products and those currently

under development, or result in unanticipated product obsolescence. Such launches continue to occur, and potentially

competitive products are in various stages of development. We could also face competition for use of limited

international infusion sites, particularly in new markets as competitors launch new products. We cannot predict with

accuracy the timing or impact of the introduction of competitive products that treat diseases and conditions like those

treated by our products or product candidates. In addition, our competitors and potential competitors compete with us in

recruiting and retaining qualified scientific, clinical research and development and management personnel, establishing

clinical trial sites, registering patients for clinical trials, as well as in acquiring technologies complementary to, or

necessary for, the development of our products.

There can be no assurance that our competitors are not currently developing, or will not in the future develop,

technologies and products that are equally or more effective, are more economically attractive, and can be administered

more easily than any of our current or future technologies or products.

Competing products or technology platforms may gain faster or greater market acceptance than our products or

technology platforms and medical advances or rapid technological development by competitors may result in our


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products and product candidates or technology platforms becoming non-competitive or obsolete before we are able to

recover our research and development and commercialization expenses. If we, our products and product candidates or

our technology platforms do not compete effectively, it is likely to have a material adverse effect on our business,

financial condition and results of operation.

We will face significant challenges in successfully commercializing our products and additional product candidates

after they are launched.

The commercialization of VYVGART in new indications or other product candidates once approved, or entrance of any

of our products or product candidates into new markets will require us to further expand our sales and marketing

organization, enter into collaboration arrangements with third parties, outsource certain functions to third parties, or use

some combination of each. We have built, and continue to expand, our sales forces in certain of the countries where

VYVGART is approved and plan to further develop our sales and marketing capabilities to promote our products, and

product candidates, including new indications, if and when marketing approval has been obtained in other relevant

jurisdictions.

Even if we successfully expand our sales and marketing capabilities, either on our own or in collaboration with third

parties, we may fail to launch or market our products effectively. Recruiting and training a specialized sales force is

expensive and the costs of expanding an independent sales, marketing and/or promotion organization could be greater

than we anticipate. We could further encounter difficulties in our sales or marketing, due to regulatory actions, shut-

downs, work stoppages or strikes, approval delays, withdrawals, recalls, penalties, supply disruptions, shortages or

stock-outs at our facilities or third-party facilities that we rely on, reputational harm, the impact to our facilities due to

pandemics or natural or man-made disasters, including as a result of climate change, product liability, and/or

unanticipated costs. In addition, recruiting and training a sales force is time-consuming and could delay any product

launch. In the event that any such launch is delayed or does not occur for any reason, we would have prematurely or

unnecessarily incurred these commercialization expenses, and our investment would be lost if we cannot retain or

reposition our sales and marketing personnel.

We have entered into distribution agreements with Medison, Zai Lab, Genpharm and Handok to perform sales and

marketing services in Israel, Central and Eastern Europe, Mainland China, the Gulf Cooperation Council and South

Korea, respectively. Under these agreements, our product revenues or the profitability of these product revenues could be

lower than if we were to market and sell the products that we develop ourselves. Such distribution agreements may place

the commercialization of our products outside of our control, including over the amount or timing of resources that our

distribution partners devote to our products. Furthermore, our distributors’ willingness or ability to comply with and

complete their obligations under our arrangements may be adversely affected by business combinations or significant

changes in our distributors’ business strategies. In addition, we may not succeed in entering into arrangements with third

parties to sell and market our products or may be unable to do so on terms that are favorable to us.

Our products and product candidates for which we have obtained or intend to seek approval as biological products,

including for new indications, may face biosimilar competition.

In the U.S., the Biologics Price Competition and Innovation Act (BPCIA) created an abbreviated approval pathway for

biological products that are demonstrated to be “biosimilar” to or interchangeable with a U.S. FDA-licensed reference

biological product. However, during the 12-year regulatory exclusivity period applicable to reference biological

products, another company may still market a competing version of the reference product if the FDA approves a full

BLA for the competing product containing the sponsor’s own preclinical data and data from adequate and well-

controlled clinical trials of their product.

We believe that any of our product candidates approved as a biological product under a BLA in the U.S. should qualify

for the Biologics Price Competition and Innovation Act 12-year period of exclusivity, as is the case with VYVGART

and VYVGART HYTRULO. The base regulatory exclusivity period for VYVGART and VYVGART HYTRULO is

expected to extend until December 2033 in the U.S. whereas regulatory protection in the EU is expected to expire in

August 2032 in the EEA and March 2033 in the UK. However, in the U.S., there is a risk that this exclusivity could be

shortened due to congressional action or otherwise, or that the FDA will not consider our product candidates to be

reference products for competing products, potentially creating the opportunity for competition by biosimilar products

sooner than anticipated. The same applies to the EU, as there is also a risk that this exclusivity could be shortened due to

legislative actions.

We are aware that some of our competitors may be actively developing competing or biosimilar products for

VYVGART and VYVGART HYTRULO, including for CIDP, for which VYVGART HYTRULO received FDA

approval in 2024. It is possible our competitors will be successful in developing biosimilar or interchangeable products

for our products and product candidates, and the approval of such competing products may lead to substantial

competition in the market, a decrease in sales, or force us to make VYVGART or VYVGART HYTRULO available at

lower prices due to competitive pressures. Moreover, an interchangeable biosimilar product, once approved, may be


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substituted under existing state laws for any one of our reference products. In addition, the Further Consolidated

Appropriations Act, 2020, which incorporated the framework from the Creating and Restoring Equal Access To

Equivalent Samples (CREATES) legislation, allows biosimilar developers to obtain access to reference biological

products, which may facilitate the development of biosimilars to our products. If competing or biosimilar products are

approved, the market position of our products for existing and recently approved indications may be adversely affected.

In the EU, biosimilars are evaluated for marketing authorization pursuant to a set of general and product class-specific

guidelines and in coming years, the European Commission may further revise relevant legislation and lessen the amount

of data and market exclusivity available for medicinal products. In addition, some EU Member States have adopted, or

are considering the adoption of, biosimilar uptake measures or may impose automatic price reductions upon market entry

of one or more biosimilar competitors. While the degree of competitive effects of biosimilar competition among EU

Member States may vary, continuation of policies promoting biosimilar products in the EU and in EU Member States

could erode market share or introduce competitive pricing pressures for our products and product candidates.

Enacted and future legislation could impact demand for our products which could impact our business and future

results of operations.

In the U.S., the UK, the EU and other jurisdictions, there have been a number of legislative and regulatory changes to the

healthcare systems that could affect our future results of operations. Governmental regulations that mandate price

controls or limitations on patient access to our products or establish prices paid by government entities or programs for

our products could impact our business, and our future results of operations could be adversely affected by changes in

such regulations or policies. For example, if the European Commission’s recent proposal to revise the EU’s

pharmaceutical legislation is adopted in the form proposed, we may be affected by a decrease in data and market

exclusivity for our products and product candidates in the EEA.

In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to

reduce healthcare costs in general and the cost of pharmaceuticals in particular. The IRA, enacted in August 2022,

allows, among other things, the HHS to directly negotiate the price of a statutorily specified number of high-expenditure

drugs and biologics each year that the CMS reimburses under Medicare Part B and Part D. In August 2023, CMS

announced the first 10 Part D selected drugs for negotiation, with maximum fair prices taking effect in 2026. In January

2025, CMS announced an additional 15 Part D drugs selected for negotiation, with maximum fair prices taking effect in

2027. Negotiations for Medicare Part B products will begin in 2026 with the negotiated price taking effect in 2028. The

Medicare drug price negotiation program is currently subject to legal challenges and we cannot predict the outcome of

those cases. At this time, the Trump administration is continuing to implement the IRA and to defend the law in

litigation.

The IRA also penalizes drug manufacturers that increase prices of Medicare Part D and Part B drugs at a rate greater

than the rate of inflation relative to a benchmark period. The IRA also capped out-of-pocket spending for Medicare Part

D enrollees and made other Part D benefit design changes beginning in 2024. Beginning in 2025, the IRA eliminated the

coverage gap (and the Coverage Gap Discount Program), lowered the enrollee maximum out-of-pocket cost to $2,000,

and established a new manufacturer discount program, which requires manufacturers to provide discounts on their

applicable drugs equal to 10% in the initial phase, and 20% in the catastrophic phase of the Part D benefit. Although

these discount percentages are lower than coverage gap discounts, the new catastrophic phase discounts could be

considerable for certain high-cost drugs and may exceed those coverage gap discounts previously provided. These Part D

design changes also increase costs to Part D plans and may incentivize Part D plans to exclude certain drugs from their

formularies, which could affect the supply, demand, and pricing of our product and product candidates.

The HHS has and will continue to issue and update guidance and rulemaking as these IRA programs are implemented.

We cannot predict how the HHS will interpret the IRA in the future, or whether the U.S. Congress will enact legislation

that amends the law. However, at this time, the Trump administration is continuing to implement the IRA. Manufacturers

that fail to comply with the IRA may be subject to significant penalties, including civil monetary penalties and excise

taxes. The IRA also extends enhanced subsidies for individuals purchasing health insurance coverage in ACA (as

defined below) marketplaces through plan year 2025. Thus, while the full economic impact of IRA is unknown at this

time, the law’s passage is likely to affect the pricing of our products and product candidates. The adoption of restrictive

price controls in new jurisdictions, more restrictive controls in existing jurisdictions, the adoption of these lower prices

by commercial payors, or the failure to obtain or maintain timely or adequate pricing could also adversely impact

revenue. We expect pricing pressures will continue globally.

Further, at the U.S. state level, legislatures are increasingly enacting laws and implementing regulations designed to

control pharmaceutical and biological product pricing, including price or reimbursement constraints, discount

requirements, price transparency reporting, and programs designed to encourage importation from other countries and

bulk purchasing. States are also enacting laws modeled on federal policies, such as the IRA and the 340B drug discount

program. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of

which could limit the amounts that federal and state governments will pay for healthcare products and services, including


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pharmaceuticals, which could result in reduced demand for our products and product candidates or additional pricing

pressures. It is too early to predict whether and how the policies and priorities of the new U.S. presidential administration

could materially impact the regulation governing our products and product candidates.

The EU, on the other hand, has reopened the entire legislative framework for medicinal products. On April 26, 2023, the

European Commission has published its proposal for a new directive (COM/2023/192 final) and a new regulation

(COM/2023/193 final), which would revise and replace the existing general pharmaceutical legislation, including e.g.,

Directive 2001/83/EC, as well as Regulations (EC) No. 726/2004, No. 141/2000, or No. 1901/2006 (EU Pharmaceutical

Legislation). This proposal is currently undergoing the ordinary legislative procedure in the European Parliament and

Council of the European Union and is therefore still subject to changes. If at all, the EU Pharmaceutical Legislation is

expected to be implemented at the earliest in the next few years. Prevention and mitigation of medicine shortages,

simplification of the market entry of generics and biosimilars, the reduction of the regulatory burden (e.g., by increased

digitalization) and the implementation of a new regime for data and / or market exclusivity (e.g., by reducing the

minimum period while introducing factors that, if met, prolong protections for MA holders) are among the major

objectives pursued by the European Commission. Pending the outcome of the legislative procedure, the impact could be

positive with respect to certain regulatory processes. There could, however, also be a negative impact on innovative

pharma and biotech companies such as argenx due to shorter baseline regulatory and orphan exclusivities if the proposal

is not amended.

Following its exit from the EU, the UK is not required to reflect future changes to EU Pharmaceutical Legislation in its

own domestic regulatory regime (subject to ongoing alignment in respect of pharmaceuticals marketed in Northern

Ireland). However, other legislative and regulatory changes to the healthcare systems that could affect our future results

of operations are possible.

We are subject to government pricing laws, regulation and enforcement. These laws affect the prices we may charge

the government for our products and the reimbursement our customers may obtain from the government. Our failure

to comply with these laws could harm our results, operations and/or financial conditions.

In the U.S., we are required to participate in various government programs for our products to be reimbursed or

purchased by the federal government. We participate in programs such as the Medicaid Drug Rebate Program, the 340B

drug discount program, Medicare Part B, Medicare Part D and the U.S. Department of Veterans Affairs Federal Supply

Schedule pricing program. The requirements vary by program, but we are, among other things, required to enter into

agreements with and calculate and report prices and other information to certain government agencies, charge no more

than statutorily mandated ceiling prices and calculate and pay rebates and refunds for certain products.

The calculations are complex and are often subject to interpretation by us, governmental agencies and the courts. If we

determine that the prices we reported were in error, we may be required to restate those prices and pay additional rebates

or refunds to the extent we understated the rebate or overcharged the government due to the error. Additionally, there are

penalties associated with submission of incorrect pricing or other data by the specified deadline, as well as potential

allegations under the False Claims Act and other laws and regulations.

Recently enacted legislation in the U.S. has imposed additional rebates under government programs. For example,

effective January 1, 2024, under the American Rescue Plan of 2021, the cap on Medicaid drug rebates at 100 percent of

the average manufacturer price was eliminated, which may require pharmaceutical manufacturers to pay more in

Medicaid rebates than they receive on the sale of products. In addition, the Infrastructure Investment and Jobs Act,

effective January 1, 2023, requires manufacturers of certain single-source drugs (including biologics and biosimilars)

separately paid for under Medicare Part B for at least 18 months and marketed in single-dose containers or packages

(known as refundable single-dose containers or single-use package drugs) to provide refunds for discarded units that

exceed a defined applicable percentage. Manufacturers that fail to pay such refunds shall be subject to civil monetary

penalties. This requirement applies to VYVGART, and potentially other of our products in the future. As a result, we

owe refunds to CMS starting this year. Although we will evaluate options to reduce the amount of refunds owed,

pursuing any such actions will be time-consuming and costly. Even if we invest resources to reduce the amount of

refunds owed to CMS, it is possible that we will be delayed or unsuccessful in achieving a reduction worthy of our

investment.

Maintaining compliance with these government price reporting and discounting obligations is time-consuming and

costly, and a failure to comply can result in substantial fines, penalties, all of which could adversely impact our financial

results.

We may not obtain or maintain adequate pricing and coverage or reimbursement status for our products and product

candidates.


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Sales of VYVGART and VYVGART SC and our product candidates, if approved, will depend, in part, on the extent to

which third-party payors, including government health programs in the U.S. (such as Medicare Parts B and D and

Medicaid) and other countries, commercial health insurers, and managed care organizations, provide coverage and

establish adequate reimbursement levels for such products and product candidates. Patients generally rely on third-party

payors to reimburse all or part of the associated healthcare costs, and are unlikely to use our products unless coverage is

provided and reimbursement is adequate to cover a significant portion of the cost of our products.

In the U.S., no uniform policy of coverage and reimbursement for products exists among commercial third-party payors.

Commercial third-party payors decide which products they will pay for and establish reimbursement levels, often relying

upon Medicare coverage policy and payment limitations. However, decisions regarding the extent of coverage,

formulary tier placement, utilization management requirements (including step therapy), and the amount of

reimbursement to be provided for any product candidate that we develop through approval will be made on a plan-by-

plan basis. Even under U.S. government healthcare programs such as Medicare and Medicaid, coverage and

reimbursement policies can vary significantly. Medicare Part D is administered by commercial insurance companies

under contract with the CMS, and their coverage and reimbursement policies may vary, subject to certain statutory and

regulatory requirements. Additionally, Medicaid programs vary from state to state in their coverage policies and

reimbursement rates, subject to certain federal requirements. Further, from time to time, typically on an annual basis,

payment rates are updated and revised by third-party payors. Such updates could impact the demand for our products, to

the extent that patients who are prescribed our products, if approved, are not separately reimbursed for the cost of the

product.

The process for determining whether a third-party payor will provide coverage for a product may be separate from the

process for setting the price of a product or for establishing the reimbursement rate that such a payor will pay for the

product. Even if we do obtain adequate levels of reimbursement, third-party payors, such as government or private

healthcare insurers, carefully review and increasingly question the coverage of, and challenge the prices charged for,

products. Increasingly, third-party payors are requiring that biopharmaceutical companies provide them with

predetermined discounts from list prices and are challenging the prices charged for products. We may also be required to

conduct expensive pharmacoeconomic studies to justify the coverage and the amount of reimbursement for particular

medications. We cannot be sure that coverage and reimbursement will be available for any product that we

commercialize and, if reimbursement is available, what the level of reimbursement will be.

Moreover, coverage policies and third-party payor reimbursement rates may change at any time. Therefore, even if

favorable coverage and reimbursement status is attained for one or more products for which we receive marketing

approval in one or more indications, less favorable coverage policies and reimbursement rates may be implemented in

the future. For instance, even though favorable coverage and reimbursement status has been attained for VYVGART for

the treatment of gMG in the U.S., access to VYVGART for any other indication may be reduced or restricted by limited

payor coverage due to treatment criteria, which may prevent us from realizing its full commercial potential. In addition,

the coverage and reimbursement levels for our products for the treatment in one indication may have an adverse impact

on the coverage and reimbursement levels of such products or product candidates in other indications for which

marketing approval has previously been or may subsequently be obtained. Inadequate coverage or reimbursement may

diminish or prevent altogether any significant demand for our products and/or may prevent us entirely from entering

certain markets or indications, which would prevent us from generating significant revenues or sustaining net

profitability in the future, which would adversely affect our business, financials and results of operations.

In many foreign countries, pricing, coverage, and level of reimbursement of prescription drugs are subject to

governmental control, and we and our collaborators may be unable to obtain coverage, pricing, and/or reimbursement on

terms that are favorable to us or necessary for us or our collaborators to successfully commercialize our marketed

products in those countries. In some foreign countries, the proposed pricing for a drug must be approved before it may be

lawfully marketed. The requirements governing drug pricing and reimbursement vary widely from country to country,

and may take into account the clinical effectiveness, cost, and service impact of existing, new, and emerging drugs and

treatments. For example, the EU provides options for EU Member States to restrict the range of medicinal products for

which their national health insurance systems provide reimbursement and to control the prices of medicinal products for

human use. An EU Member State may approve a specific price for the medicinal product or it may instead adopt a

system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. Our

results of operations may suffer if we or our collaborators are unable to market our products in foreign countries or if

coverage and reimbursement for our marketed products in foreign countries is limited or delayed.

If we fail to obtain orphan drug designation or we do not have valid and enforceable patents covering our products

and their uses and product candidates and fail to obtain and/or maintain orphan drug exclusivity for our products or

product candidates, our competitors may be able to sell products to treat the same conditions and our revenue may be

reduced.

We have and may from time to time seek orphan drug designation in the U.S., Japan, or the EU for certain indications

addressed by our products and product candidates. With regard to these designations or future designations we may


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obtain, we may not be the first to obtain marketing approval of these drugs for such indication due to the uncertainties

associated with developing therapeutic products, and we may not obtain orphan exclusivity upon approval. In addition,

exclusive marketing rights in the U.S. may be limited if we seek approval for an indication broader than the orphan-

designated indication, or may be lost if the FDA later determines that the request for designation was materially

defective or if we are unable to assure sufficient quantities of the product to meet the needs of patients with the rare

disease or condition. Further, even if we obtain orphan drug exclusivity for a product, that exclusivity may not

effectively protect the product from competition because different drugs with different active moieties or different

principal molecular structural features can be approved for the same condition. Even after an orphan drug is approved,

the MHRA, the EMA, the FDA, the MHLW (collectively, the Relevant Regulatory Authorities) or other comparable

regulatory authorities can subsequently approve the same drug with the same principal molecular structural features for

the same condition if the regulator concludes that the later drug is safer, more effective, or makes a major contribution to

patient care.

Further, in the U.S., a September 2021 Eleventh Circuit decision in Catalyst Pharmaceuticals, Inc. vs. Becerra regarding

interpretation of the Orphan Drug Act exclusivity provisions as applied to drugs approved for orphan indications

narrower than the drug’s orphan designation could significantly broaden the scope of orphan drug exclusivity for such

products. In January 2023, the FDA, however, issued a Federal Register notice clarifying its approach to orphan drug

exclusivity following the Catalyst decision. Consistent with the court’s decision, the FDA set aside its approval of the

drug at issue in the case, but announced that, while complying with the court’s order in Catalyst, the FDA intended to

continue to apply its regulations tying the scope of orphan-drug exclusivity to the uses or indications for which a drug is

approved to matters beyond the scope of that order. Legislation has also been introduced that may reverse the Catalyst

decision but its passage is uncertain at this time.

Risk Factors Related to the Development and Clinical Testing of argenx’s Products and Product Candidates

Failure to successfully identify, select and develop our products in other indications, or additional products or

product candidates could impair our ability to grow.

Our long-term growth strategy entails developing and marketing additional products and product candidates, including

efgartigimod for new indications, empasibrubart and ARGX-119. This requires substantial resources, whether or not any

product candidates or new indications are ultimately identified. The success of this strategy depends partly upon our

ability to identify, select, develop, and ultimately, commercialize promising product candidates. We are heavily

dependent on precise, accurate and reliable scientific data to identify, select and develop promising product candidates

and products. Our business decisions may therefore be adversely influenced by inaccurate, improper or fraudulent

scientific data, including data sourced from third parties. Even with accurate scientific data, our technology platforms

may fail to discover and to generate additional products and products candidates, that are suitable for further

development.

Even if we identify additional product candidates, they may not be suitable for clinical development as a result of

harmful side effects, limited efficacy or other characteristics that indicate that it is unlikely to be a product that will

receive approval by the Relevant Regulatory Authorities, and other comparable regulatory authorities or achieve market

acceptance. For example, we have previously announced that certain clinical trials did not meet their primary endpoints.

We consequently decided not to pursue additional development in pemphigus and plan to prioritize clinical development

of efgartigimod in its ongoing severe autoimmune indications. If we do not successfully identify, develop and

commercialize product candidates and VYVGART in new indications based upon our technological approach, we may

not be able to obtain product or collaboration revenues in future periods.

Obtaining regulatory approval for our products and product candidates is inherently uncertain. To obtain the requisite

regulatory approvals to market and sell any of our products and product candidates, we or our collaborators for such

candidates must successfully demonstrate that our products are safe and effective in humans. Clinical trials are expensive

and can take many years to complete, and their outcome is inherently uncertain. Further, success in early clinical trials or

in one indication does not guarantee success in later clinical trials or in other indications.

Failure to successfully develop or obtain marketing approval for our products and product candidates could

negatively impact our business.

The time required to obtain approval by the Relevant Regulatory Authorities and other comparable regulatory authorities

is unpredictable but typically takes many years, if obtained at all, following the commencement of clinical trials and

depends upon numerous factors, including the substantial discretion or interpretation of the regulatory authorities. This

lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain

regulatory approval to market any of our product candidates, including for new indications. We may experience delays in

our ongoing or planned clinical trials, for a large variety of reasons outside our control in complying with regulatory

approvals which can adversely affect the timing of clinical trials, including as described in “Item 3.D. — Risk Factors —


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Risk Factors Related to Other Government Regulations — All aspects of our business ranging from preclinical, clinical

trials, marketing and commercialization are highly regulated and any delay by relevant regulatory authorities could

jeopardize our development and approval process or result in other suspensions, refusals or withdrawal of approvals.”

In addition, ongoing efforts by the Trump administration to limit the size of the FDA and other agencies of HHS,

including through reductions in staff, may further increase the unpredictability in approval timelines for our products and

product candidates. For example, on February 11, 2025, President Trump issued an executive order on workforce

optimization, seeking to reduce the size of the federal workforce through large-scale reductions in force and by placing

limitations on the number of new employee hires. Whether this executive order and other similar Trump administration

efforts to reduce the federal work force will have an adverse effect on FDA’s ability to timely review drug and biologic

product applications remains uncertain.

If we are unable to obtain regulatory approval of our products and product candidates on a timely basis or at all, our

business, financial operations and/or financial condition may be impacted.

Certain of our clinical trials have not succeeded, and may in the future also not succeed, and even if they succeed, we

may not obtain regulatory approval for our products or product candidates or regulatory approval may be delayed.

Certain of our clinical trials have not succeeded, and may in the future also not succeed. We could experience

operational challenges as we undertake an increasing number of clinical trials, including those conducted in countries

outside the EU, UK and the U.S. that may subject us to further delays and expenses as a result of increased shipment

costs, additional regulatory requirements and the engagement of non-EU, non-UK and non-U.S. contract research

organizations (CROs), as well as expose us to risks associated with clinical investigators and institutions who apply

different standards of diagnosis, screening and medical care or are otherwise unfamiliar with standards and requirements

imposed by the Relevant Regulatory Authorities.

If we experience delays in the completion of, or termination of, any clinical trial of our products or product candidates,

our commercial prospects may be harmed. Any delays in completing our clinical trials may increase our costs, slow

down our product candidate development and approval process and jeopardize our ability to commence product sales

and generate revenues. Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical

trials may also ultimately lead to the denial of regulatory approval of our product candidates or result in the development

of our product candidates being stopped early. Significant clinical trial delays could also allow our competitors to bring

products to market before we do or shorten any periods during which we have the exclusive right to commercialize our

products and product candidates.

Even if clinical trials are initiated, our development efforts may not be successful. Even if we obtain positive results from

preclinical trials or initial clinical trials, we may not achieve the same success in future clinical trials, which may

negatively impact the price of our ordinary shares or ADSs.

Regulatory approval of our products or product candidates may be delayed or refused for many reasons, including for

reasons outside our control such as:

•the Relevant Regulatory Authorities or other comparable regulatory authorities may disagree with the design or

implementation of our clinical trials;

•we may be unable to demonstrate, to the satisfaction of the Relevant Regulatory Authorities or other comparable

regulatory authorities, that our product candidates are safe, pure, potent and effective for any of their proposed

indications;

•the results of clinical trials may not meet the level of statistical significance required by the Relevant Regulatory

Authorities or other comparable regulatory authorities for approval;

•the chemistry, manufacturing and controls information submitted in an application is insufficient; and

•the facilities of third-party manufacturers with which we contract for the manufacture of our product candidates are

not adequate to support approval of our product candidates.

Any of these occurrences may harm our business, results of operations and financial condition significantly.

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If we decide to pursue accelerated approval for any of our product candidates, it may not lead to faster development

or regulatory review or approval and we may still need to conduct additional clinical trials, which could increase the

expense of obtaining, if at all, necessary marketing approvals.

Recently, the accelerated approval pathway has come under scrutiny by various stakeholders, and the FDORA revised

the requirements for this pathway. Although this legislation did not change the standard for accelerated approval, the

FDA is now authorized to require a post-approval clinical trial to be underway prior to approval or within a specified

time period following approval, and must specify conditions of any required post-approval clinical trial. FDORA also

requires sponsors to submit progress reports for required post-approval studies. Failure to conduct due diligence for

required post-approval studies is deemed a prohibited act under the FDCA. FDORA also details procedures the FDA

must follow to withdraw an accelerated approval on an expedited basis, including where the required post-approval

studies are not conducted with due diligence or fail to verify clinical benefit, other evidence demonstrates that the

product is not shown to be safe or effective under the conditions of use, or the sponsor disseminates false or misleading

promotional materials with respect to the product.

If we decide to pursue accelerated approval for any of our product candidates, the failure to obtain accelerated approval

(or the withdrawal of any accelerated approval) could result in a longer time period to commercialization of such product

candidate, if any, and could increase the cost of development of such product candidate and harm our competitive

position in the marketplace. For example, if standard of care were to evolve or if any of our competitors were to receive

approval for a drug or biological product for a disease or condition for which we are seeking accelerated approval before

we receive accelerated approval, we may not be able to demonstrate that our product candidate provides a meaningful

advantage over other available therapies and accelerated approval may not occur.

Our products and product candidates may have serious adverse, undesirable or unacceptable side effects, and we or

others may identify undesirable or unacceptable side effects caused by any of our products or product candidates

before and after they have received marketing approval.

Undesirable side effects that may be caused by our product candidates, or by the combination of our product candidates

with other medical products, could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could

result in more restrictive labeling or the delay or denial of regulatory approval by the Relevant Regulatory Authorities or

other comparable regulatory authorities. We have observed adverse events and treatment emergent adverse events in our

clinical trials, and we may see additional adverse events and treatment emergent adverse events in our ongoing and

future clinical trials. Such side effects may be more serious than those observed to date, and as a result, our ongoing and

future clinical trials may be negatively impacted. Moreover, as we seek to develop product candidates, including

products in new indications, patients may experience new or more serious effects. Drug-related side effects caused by

any of our products or product candidates that we or others identify could, among other things, affect patient recruitment,

the ability of enrolled patients to complete the clinical trial, result in potential product liability claims, damage sales of

our existing products, result in significant reputational damage for us and our product development, and other issues

including the delay of other programs.

They can also cause the Relevant Regulatory Authorities or other comparable regulatory authorities to withdraw

approvals or revoke licenses of such products and require us to take such products off the market, require the addition of

labeling statements, specific warnings, or a contraindication or other modification of the product labeling, request the

issuance of safety alerts, require a REMS to ensure that the benefits of the product outweigh its risks, and/or require us to

change the way the product is administered, conduct additional clinical trials or change the labeling of the product.

If our target patient population is smaller than expected, we are unable to successfully enroll and retain patients in

our clinical trials, or experience significant delays in doing so, we may not realize the full commercial potential of

any products or product candidates.

Currently, we mainly develop products or product candidates for the treatment of rare diseases for which the target

patient population can be small. If the actual number of patients with these disorders is smaller than we expected, we

may encounter difficulties in enrolling sufficient patients in our clinical trials, thereby delaying or preventing

development and approval of our products or product candidates. Physicians, who are an important source of patients for

clinical trials, may also be less familiar with these rare diseases and may therefore fail to identify these conditions in

their patients and therefore may not refer them to our clinical trials.

Patient enrollment, a significant factor in the timing of clinical trials, depends on many factors, including the size and

nature of the patient population, eligibility criteria for the clinical trial, the proximity of patients to clinical sites,

competition for patient recruitment from competing clinical trials, the design of the clinical trial, the availability of

alternate approved therapies for the indication the clinical trial is investigating, and clinicians’ and patients’ perceptions

as to the potential advantages of the drug being studied in relation to other available therapies. We compete with other

companies to enroll target patient populations, as set forth in “Item 3.D. Risk Factors—Risk Factors Related to


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Commercialization of argenx’s Products and Product Candidates, Including for New Indications—We face significant

competition for our drug discovery and development efforts.” Even if product candidates obtain significant market share

for their approved indications, because certain potential target populations are small, we may never recoup our

investment in such product candidate without obtaining regulatory approval for additional indications for such product

candidates.

Even once enrolled, we may be unable to retain a sufficient number of patients to complete any of our clinical trials. In

addition, any negative results we may report in clinical trials of our drug candidates may make it difficult or impossible

to recruit and retain patients in other clinical trials of that same drug candidate. Delays in the completion of any clinical

trial of our product candidates will increase our costs, slow down our product candidate development and approval

process and delay or potentially jeopardize our ability to commence product sales and generate revenue. In addition,

some of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also

ultimately lead to the denial of regulatory approval of our product candidates.

Risk Factors Related to argenx’s Dependence on Third Parties

We rely, and expect to continue to rely, on third parties to conduct some of our research activities and clinical trials

and for parts of the development and commercialization of our existing and future research programs, products and

product candidates. If our relationships with such third parties are not successful, our business may be adversely

affected.

We have relied upon and plan to continue to rely upon third parties, including independent clinical investigators, CROs,

CMOs and other third-party service providers with the applicable protocol, legal and regulatory requirements and

scientific standards, and our reliance on these third parties does not relieve us of our regulatory responsibilities. To the

extent our collaborators or the CROs or investigators fail to enroll participants for our clinical trials, fail to conduct the

clinical trial to GCP standards or in full compliance with legal and regulatory requirements or are delayed for a

significant time in the execution of clinical trials, including achieving full enrollment, we may be affected by increased

costs, program delays or both, which may harm our business.

In addition, we are, and expect to continue to be, dependent on partnerships with partners and licensees relating to the

development and commercialization of our existing and future research programs, products and product candidates. We

currently have collaborative research relationships with various pharmaceutical companies such as AbbVie, Zai Lab,

Genmab and with various academic and research institutions worldwide for the development of product candidates

resulting from such collaborations. We also have distribution agreements in place with Medison, Genpharm and Handok

for the distribution of VYVGART. We had, have and will continue to have discussions on potential partnering

opportunities with various pharmaceutical companies. If we fail to enter into or maintain collaborations on reasonable

terms or at all, our ability to develop our existing or future research programs and product candidates and to

commercialize our existing or future products could be delayed, the commercial potential of our products could change

and our costs of development and commercialization could increase.

While we have agreements governing our relationships with these third parties, we have limited influence over their

actual performance and control only certain aspects of their activities. If independent investigators, third-party service

providers or CROs fail to devote sufficient resources to the development of our product candidates, or if their

performance is substandard, it may delay or compromise the prospects for approval and commercialization of any

product candidates that we develop. In addition, regulatory authorities enforce GCP requirements through periodic

inspections of clinical trial sponsors, principal investigators and clinical trial sites. If we, our investigators or any of our

CROs fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable

and the Relevant Regulatory Authorities or comparable regulatory authorities may require us to perform additional

clinical trials before approving our marketing applications. Upon inspection by a given regulatory authority, such

regulatory authority may determine that our clinical trials do not fully comply with GCP regulations, which may require

us to repeat clinical trials and delay the regulatory approval process. Our collaborative partners may not adhere to or may

terminate collaboration agreements with all associated consequences or disagree on the interpretation of contractual

terms. We may not be able to control our collaborative partners’ compliance with all applicable requirements for the

commercialization of our products, which could adversely affect such commercialization and the profitability of such

products. Failures by our collaborative partners to meet their contractual, regulatory, or other obligations to us, or any

disruption in the relationships between us and our collaborative partners, could have a material adverse effect on our

product pipeline and business.

We face significant competition in establishing successful relationships with third-party service providers and

appropriate collaborative partners. These third-party service providers may have contractual relationships with other

entities, some of which may be our competitors, which may draw their time and resources away from our programs. In

addition, some of our third-party service providers or CROs have the ability to terminate their respective agreements

with us, and if such agreements terminate, we may not be able to enter into arrangements with alternative CROs or

investigators or to do so on commercially reasonable terms. In addition, we may not be able to find appropriate


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collaboration partners. Our ability to reach a definitive agreement for a partnership will depend, among other things,

upon an assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed partnership

and the proposed collaborator’s evaluation of a number of factors. These factors may include the design or results of

clinical trials, the likelihood of regulatory approval, the potential market for the subject product candidate, the costs and

complexities of manufacturing and delivering such product candidate to patients, the potential of competing products, the

existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such

ownership regardless of the merits of the challenge and industry and market conditions generally. The collaborator may

also consider alternative product candidates or technologies for similar indications that may be available to collaborate

on and whether such a partnership could be more attractive than the one with us. In addition, in the U.S., legislative,

executive and regulatory proposals were recently enacted or are pending to, among other things, prevent drug shortages,

improve pandemic preparedness and reduce the dependency of the United States on foreign supply chains and

manufacturing. While we are still assessing these developments, they could impact our selection and utilization of

CMOs, vendors and other suppliers and could have a material adverse impact on our business, financial condition and

results of operations.

Disruptions caused by our reliance on third parties for our manufacturing process may delay or disrupt our business,

product development and commercialization efforts.

We do not have the ability to internally source the raw materials necessary to produce our products or product

candidates, and do not currently have, nor do we plan to acquire, the infrastructure or capability internally to

manufacture our products or product candidates and depend on a worldwide supply chain and third parties for both.

Disruptions caused by our reliance on such third-party suppliers, service providers and manufacturers may delay or

disrupt our business, product development and commercialization efforts.

Reliance on Third-Party Suppliers and Service Providers

For some of our raw materials, we rely on a single source of supply and there are limited supplies of the raw materials. If

prices increased, or we were to experience an unexpected loss of supply of or if any supplier was unable to meet our

demand for any of our products and product candidates, including for example if VYVGART is approved for additional

indications, we could experience delays in our research or planned clinical trials or risk shortages in commercial supply

which could materially impact our revenue potential. These issues could be exacerbated by pressure on the supply chain,

for example due to power shortages, telecommunications failures, natural disasters such as floods, hurricanes and

wildfires, extreme weather conditions, public health crises, changed laws or regulations or geopolitical events, including

trade disputes or economic sanctions enacted as a result of international conflict. The cost of our raw materials may also

increase based on increased tariffs on foreign exports. As we continue to grow our business we may need to establish

additional sources of supply for our products. The lead time needed to establish a relationship with a new supplier can be

lengthy and require us to devote substantial time and resources. The time and effort to qualify a new supplier could result

in additional costs, or delays, which could adversely affect our business.

Additionally, certain of the raw materials required in the manufacture and the formulation of our products and product

candidates may be derived from biological sources, including mammalian tissues, bovine serum and human serum

albumin. There are certain European regulatory restrictions on using these biological source materials including rigorous

testing requirements, which could limit or delay production. Regulatory authorities may require additional studies if we

adopt a new supplier. If there are changes in the regulation requirements that our suppliers are unable to meet, our

clinical development or commercial activities may be delayed or interrupted.

We may not be able to engage a back-up or alternative supplier or service provider in a timely manner or at all if any of

these third parties were to cease or interrupt production or otherwise fail to supply these materials, products, or services

to us for any reasons, including due to regulatory requirements or actions (including recalls), adverse financial

developments at or affecting the supplier, failure by the supplier to comply with cGMPs, contamination, business

interruptions, or labor shortages or disputes. Interruptions in the supply of these materials, products or services may also

result from international conflict, trade disputes or economic sanctions enacted by, or imposed on, the U.S., the UK, the

EU or any other country or region.

Reliance on Third-Party Manufacturing

We rely on and expect to continue to rely on CMOs. We also rely on certain third parties to perform filling, finishing,

distribution, laboratory testing and other services related to the manufacture and supply of our products and product

candidates.

We do not control the manufacturing process at our CMOs and are completely dependent on them for the production of

our products and product candidates in accordance with relevant regulations (such as cGMPs), we are responsible for

ensuring that our products comply with regulatory requirements. If our CMOs cannot successfully manufacture material

that conforms to our specifications and the strict regulatory requirements of the Relevant Regulatory Authorities or other


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comparable regulatory authorities, our business could be adversely affected, including an inability to initiate or continue

clinical trials of product candidates under development, delay in submitting regulatory applications, or receiving

regulatory approvals for product candidates, including new indications, subjecting third-party manufacturing facilities to

additional inspections by regulatory authorities, requirements to cease distribution or to recall batches of our products or

product candidates and an inability to meet commercial demands for our marketed products.

Most notably, we contract with Lonza for their manufacturing sites in Slough, UK, Portsmouth, U.S, Singapore and

Visp, Switzerland as well as with Fujifilm, based in Denmark for activities relating to the development of cell banks,

development of our manufacturing processes and the manufacturing of drug substance. We use additional contract

manufacturers to fill, test, label, package, store and distribute our (investigational) drug products. Our products and

product candidates are biologics and require multiple processing steps that are more difficult than those required for most

small molecule chemical pharmaceuticals. While we work with our CMOs and partners on optimization, strengthening

and upscaling our manufacturing, problems with these manufacturing processes, such as capacity issues, or even minor

deviations from the normal process or from the materials used in the manufacturing process, which may not be

detectable by us in a timely manner, could lead to manufacturing failures or product defects, resulting in lot failures,

product recalls, product liability claims and insufficient inventory.

We face risks inherent in relying on limited CMOs, as any failure in their ability to successfully manufacture our

products or product candidates as described above or any disruption, such as supply shortages or disruptions of raw

materials, fires, pandemics, natural hazards or acts of vandalism at the CMO could significantly interrupt our

manufacturing capability. Alternative production plans in place or disaster-recovery facilities available to us may not be

sufficient. In case of a disruption, we may have to establish additional alternative manufacturing sources. This would

require substantial investment on our part, which we may not be able to obtain on commercially acceptable terms or at

all. Additionally, we may experience significant manufacturing delays as we build or locate replacement facilities and

seek and obtain necessary regulatory approvals. If this occurs, we will be unable to satisfy manufacturing needs on a

timely basis, if at all. Also, operating any new facilities may be more expensive than operating at our current facilities.

Further, business interruption insurance may not adequately compensate us for any losses that may occur, and we would

have to bear the additional cost of any disruption. For these reasons, a significant disruptive event of the manufacturing

facility could have drastic consequences, including placing our financial stability at risk.

Accuracy and timing of our financial reporting is partially dependent on information received from third-party

partners, which we do not control.

We have collaborated, and plan to continue to collaborate, with third parties, including distributor and licensing partners,

on certain product candidates. As part of some of these collaborations, our collaboration partners are responsible for

providing us with financial information regarding specific projects, including funds spent, liabilities incurred and

expected future costs, on which we rely for our own financial reporting. If our collaboration partners fail to provide us

with the necessary financial information within the agreed upon timeframes, or if such financial information proves

inaccurate, it would adversely impact the timing and accuracy of our own financial reporting. Any inaccuracy in our

financial reporting could cause investors to lose confidence in our financial reporting. This in turn may lead to

reputational damage or affect our ability to obtain, and the terms of, any future financing, which may harm our business.

We and our third-party manufacturers and suppliers may become exposed to liability, fines, penalties or other

sanctions and substantial expenses in connection with environmental compliance or remediation activities.

Our third-party manufacturers’ and suppliers’ operations, including research, development, testing and manufacturing

activities, are subject to numerous environmental, health and safety laws and regulations. These laws and regulations

govern, among other things, the controlled use, handling, release and disposal of and the maintenance of a registry for,

hazardous materials and biological materials, laboratory procedures and exposure to pathogens. We do not have control

over our manufacturers’ or suppliers’ compliance with environmental, health and safety laws and regulations. If we, or

they fail to comply with such laws and regulations, we could be subject to liability, fines, penalties or other sanctions and

incur substantial expenses to comply or remediate the activities.

We face a risk of environmental liability inherent in our current and historical activities, including liability relating to

releases of or exposure to hazardous or biological materials. Environmental, health and safety laws and regulations are

becoming more stringent. We may be required to incur substantial expenses in connection with future environmental

compliance or remediation activities, in which case, our production and development efforts may be interrupted or

delayed, and our financial condition and results of operations may be materially adversely affected.

Risk Factors Related to Other Government Regulations

We are subject to healthcare laws, regulation and enforcement. The failure to comply with these laws could harm our

results, operations and/or financial condition.


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Our current and future operations are and may become directly, or indirectly through our customers and third-party

payors, subject to various U.S. federal and state, EU, Japanese, Chinese, UK, Canadian and Israeli healthcare laws, and

healthcare laws of other jurisdictions in which we conduct our business. This includes, but is not limited to, the U.S.

FDCA, the U.S. False Claims Act and EU Directive 2001/83/EC. EU Directive 2001/83/EC provides that where

medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages

or benefits of any kind may be supplied, offered or promised to such persons, except under certain circumstances. This

provision was also transposed into the Human Medicines Regulations 2012 in the UK.

Healthcare providers, physicians and others play a primary role in the recommendation and prescription of any products

for which we obtain marketing approval. Healthcare laws also impact our arrangements with healthcare professionals

who participate in our clinical research programs, healthcare professionals and others who recommend, purchase, or

provide our approved products, and other parties through which we market, sell and distribute our products for which we

obtain marketing approval.

Therefore, the healthcare laws we are subject to may impact, among other things, our proposed sales, marketing and

education programs and constrain our business and financial arrangements with third-party payors. For example, the

provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement,

purchase, supply, order or use of medical products is generally not permitted in countries that form part of the EU, or the

UK. Some EU Member States have enacted laws explicitly prohibiting the provision of these types of benefits and

advantages to induce or reward improper performance generally, and the UK has enacted similar restrictions.

Infringement of these laws can result in substantial fines and imprisonment, as well as associated reputational harm. Any

action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant

legal expenses and divert our management’s attention from the operation of our business.

The shifting compliance environment and the need to maintain robust and expandable systems to comply with multiple

jurisdictions with different compliance or reporting requirements increases the possibility that we or our collaborative

partners may run afoul of one or more of these requirements. We continue to expand, enhance and refine our internal

ethics and compliance function and program to ensure compliance with the different healthcare laws and regulations. As

we continue to grow our headcount to support our business, we face increased compliance risk as we need to train and

supervise additional personnel to comply with relevant healthcare laws and regulations. This involves substantial costs

and, notwithstanding our investment, there can be no assurance that our policies and procedures will be followed at all

times or will effectively detect and/or prevent all compliance violations by our employees, consultants, subcontractors,

agents and partners.

It is possible that governmental authorities will conclude that our business practices do not comply with current or future

statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our

operations are found to be in violation of any of these laws or any other governmental regulations applicable to us, we

may be subject to significant civil, criminal and administrative investigations, penalties, damages, fines, disgorgement,

imprisonment, exclusion of drugs from government funded healthcare programs, such as Medicare and Medicaid in the

U.S., additional reporting requirements and oversight, reputational harm and the curtailment or restructuring of our

operations. Managing such investigations and defending against or appealing any such actions or penalties can be costly

and time-consuming and may require significant financial and personnel resources. Therefore, even if we are successful

in managing any such governmental investigations and/or defending against or appealing any such actions or penalties

that may be brought against or imposed upon us, our business may be impaired. Efforts to ensure that our business

arrangements with third parties comply with applicable healthcare laws and regulations also involve substantial costs.

The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of

healthcare reform. In the U.S., federal and state enforcement bodies have recently increased their scrutiny of interactions

between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions,

convictions and settlements in the healthcare industry. Ensuring business arrangements comply with applicable

healthcare laws, as well as responding to possible investigations by government authorities, can be time and resource

consuming and can divert a company’s attention from the business.

All aspects of our business, including preclinical research, clinical trials, marketing and commercialization, are

highly regulated, and any delay by relevant regulatory authorities could jeopardize our development and approval

process and/or result in suspensions of marketing authorizations, refusals to approve our products, or withdrawal of

existing approvals.

Before we can commence clinical trials for a product candidate, we must complete extensive preclinical testing to

support our IND or planned IND applications in the U.S. or Japan, or our clinical trial applications (CTAs) in the UK or

in the EU, or comparable applications in other jurisdictions. We cannot be sure that we will be able to submit INDs or

CTAs or comparable applications for our development programs on the timelines we expect, if at all. We also cannot

guarantee that submission of INDs or CTAs or comparable applications will result in the Relevant Regulatory

Authorities or other regulatory authorities allowing clinical trials to begin.


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Clinical trials must be conducted in accordance with Relevant Regulatory Authorities' and other comparable regulatory

authorities’ legal requirements and regulations and are subject to oversight by these governmental agencies as well as

IRBs and ethics committees. In addition, clinical trials must be conducted in compliance with GCPs and clinical supplies

of our products and product candidates must be produced under cGMPs and other regulations. We could encounter

delays if a clinical trial is suspended or terminated, by us, by the IRB or ethics committee, by the data review committee

or data safety monitoring board for such clinical trial, or by the Relevant Regulatory Authorities or other comparable

regulatory authorities. Such authorities may impose a suspension or termination due to a number of factors, including

failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the

clinical trial operations or clinical trial site by the Relevant Regulatory Authorities or other comparable regulatory

authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, including those

relating to the class to which our products and product candidates belong, failure to demonstrate a benefit from using the

product or product candidate, changes in governmental regulations or administrative actions, or lack of adequate funding

to continue the clinical trial.

If we experience delays in the completion of, or termination of, any clinical trial of our products or product candidates,

the costs of our clinical programs may increase, the commercial prospects of our products and product candidates may be

harmed, and our ability to generate product revenues from any of these products and product candidates may be delayed.

Significant clinical trial delays could also allow our competitors to bring products to market before we do, or shorten any

periods during which we have the exclusive right to commercialize our products and product candidates.

Moreover, we must obtain separate regulatory approvals in each jurisdiction where we want to market, and approval by

one regulatory authority does not ensure approval by any other regulatory authority. As approval procedures can vary

among countries and may change over time, this can require additional clinical testing, and the time required to obtain

approval may differ. We can provide no assurances that such approval will be obtained on the timeline that we expect or

at all. In addition, we anticipate submitting applications for approval of VYVGART in new indications, but can provide

no assurances that such applications will be accepted or that we will receive approval on our anticipated timeline, or at

all.

If VYVGART or any new formulations of VYVGART are not approved in one or more jurisdictions including beyond

the countries where VYVGART is approved, or if such approvals are significantly delayed, it could have a material

adverse effect on our business. It is possible that none of our other existing product candidates or any product candidates

we may seek to develop in the future will ever obtain regulatory approval in any other jurisdiction for any indication.

Even if approval is obtained, the Relevant Regulatory Authorities or other comparable regulatory authorities may

approve the product for fewer or more limited indications or patient sub-segments than requested and/or with a label that

does not include the labeling claims necessary or desirable for the successful commercialization of that product. Further,

the Relevant Regulatory Authorities or other comparable regulatory authorities may impose extensive and ongoing

unique regulatory requirements, such as granting approval contingent on the performance of costly post-marketing

clinical trials, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product.

The costs of compliance with all Relevant Regulatory Authorities' and other applicable authorities' regulations,

requirements or guidelines could be substantial, and failure to comply could result in sanctions, including fines,

injunctions, civil penalties, denial of applications for marketing authorization of our products, delays, suspension or

withdrawal of approvals, license revocation, seizures or recalls of products, operating restrictions and criminal

prosecutions, any of which could significantly increase our and/or our collaborative partners’ costs or delay or prevent

the development and commercialization of our product candidates. At this time, we cannot guarantee or know the exact

nature, precise timing and detailed costs of the efforts that will be necessary to complete the remainder of the

development of our research programs and product candidates.

We are subject to privacy laws, regulation and potential enforcement. The failure to comply with these laws could

harm our results, operations and/or financial conditions.

Privacy laws, regulation and potential enforcement are particularly relevant to our business as we collect, store and

process patient data, including sensitive health data as well as human biological samples such as blood or tissue, in the

context of our clinical development activities, post-marketing approval monitoring obligations, and associated activities.

We also collaborate on a regular basis with third parties where we may seek to use data collected by third parties on our

or their behalf, or we may seek to share data collected by us with such third parties to further our research or commercial

initiatives.

The GDPR imposes a broad range of strict requirements on companies, including with respect to cross-border transfers

of personal data and imposes substantial penalties in the event of non-compliance. We face uncertainty as to the exact

interpretation of the requirements under the GDPR, and we may be unsuccessful in implementing all measures required

by data protection authorities or courts in interpretation of the GDPR.


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In addition, national laws of EU Member States may partially deviate from the GDPR and impose different obligations

from country to country. Also, in the field of handling genetic data, the GDPR specifically allows EU Member States’

laws to impose additional and more specific requirements or restrictions, and European national laws have historically

differed quite substantially in this field, leading to additional uncertainty. Apart from the GDPR, privacy laws continue

to evolve and expand in Europe. For example, violations of the Directive 2002/58/EC of the European Parliament and of

the Council of July 12, 2002 (as amended, the e-Privacy Directive) can result in administrative measures, including fines,

or criminal sanctions. The EU is in the process of developing a new e-Privacy Regulation to replace the e-Privacy

Directive, and the new e-Privacy Regulation may impose additional obligations and risk for our business.

Following its departure from the EU, the UK has maintained in force substantially equivalent provisions to the GDPR

(UK GDPR). Similar concerns as those described above with respect to GDPR apply to our compliance with the UK

GDPR and other UK data protection rules as well.

Beyond the EU and UK, privacy and data protection laws and regulations continue to develop and expand around the

world, including in other jurisdictions in which we operate, such as the U.S., Japan, and Canada. Such laws and

regulations impose increasing restrictions and obligations on the processing of personal data, including sensitive

personal data such as genetic data. For example, in the U.S., the federal Health Insurance Portability and Accountability

Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, and state privacy

laws, such as the California Consumer Privacy Act of 2018, as amended, and the Washington My Health My Data Act of

2023, impose obligations on covered businesses, including, but not limited to, providing specific disclosures in privacy

notices and affording residents certain rights related to their personal data. Privacy laws continue expanding globally and

may require us to modify our data collection or processing practices and to incur significant expenses associated with our

compliance efforts.

We continue to evaluate and consider whether and how to incorporate artificial intelligence solutions into certain aspects

of our business, which may pose significant risks, including to data privacy. The legal regulatory regime relating to

artificial intelligence is uncertain and evolving, and compliance with existing and new laws and regulations governing

artificial intelligence may give rise to significant costs, which could increase our operating expenses. Further, these

compliance obligations may make it harder for us to conduct our business using artificial intelligence, require us to

change our business practices, or prevent or limit our use of artificial intelligence, which could make our business less

efficient or put us at a competitive disadvantage. Implementation of artificial intelligence into our business could pose

certain risks to our patients or partners. For example, if we incorporate artificial intelligence into our business, our use of

artificial intelligence may result in cybersecurity incidents that implicate the personal data of our patients or partners.

In addition, if we are investigated by a data protection authority, we may face fines and other penalties. Any such

investigation or charges by data protection authorities could have a negative effect on our existing business and on our

ability to attract and retain new clients or pharmaceutical partners. We may also experience hesitancy, reluctance, or

refusal by clients or pharmaceutical partners to continue to use our products and solutions due to the potential risk

exposure as a result of the current and future data protection obligations. Such clients or pharmaceutical partners may

also view any alternative approaches to compliance as being too costly, too burdensome, too legally uncertain, or

otherwise objectionable and therefore decide not to do business with us. Any of the foregoing could harm our business,

prospects, financial condition and results of operations.

Failure to comply with anti-corruption laws and regulations, anti-money laundering laws and regulations, economic

sanctions and/or export control regulations and other laws governing our operations could have an adverse impact

on our business.

We are or may become subject to various laws and regulations regarding anti-corruption, anti-money laundering,

economic sanctions, investment restrictions, anti-fraud and export control regulations issued by multiple jurisdictions.

These include the UK Bribery Act 2010 and the U.S. Foreign Corrupt Practices Act of 1977, as amended, which

prohibits, among other things, payments, offers, or promises made for the purpose of improperly influencing any act or

decision of a foreign official. The nature of our business means that we engage in significant interactions with foreign

officials. In the UK, from September 1, 2025, it will also be an offense under the Economic Crime and Corporate

Transparency Act 2023 for a large organization to fail to prevent certain fraudulent activities by an associated person

(such as an employee, agent, or subsidiary), unless it can demonstrate that it had reasonable prevention procedures in

place to prevent the fraudulent activity.

We are also subject to economic sanctions and export control rules and regulations imposed by multiple jurisdictions,

including the U.S., UK, and EU. Any change in export or import regulations, economic sanctions regulations or related

legislation, shift in the enforcement or scope of existing regulations, or change in the countries, governments, persons or

technologies targeted by such regulations, could decrease our ability to manufacture, import, export or sell our products

internationally, which could adversely affect our business.


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We have mechanisms in place to promote compliance with such rules and regulations. However, there can be no

assurance that our policies and procedures will be followed at all times or will effectively detect and/or prevent

violations of applicable compliance regimes by our employees, consultants, sub-contractors, agents and partners. In the

event of non-compliance, we could be subject to substantial civil or criminal penalties, including economic sanctions

against us, incarceration for responsible employees and managers, the possible loss of export or import privileges,

reputational harm, and resulting loss of revenue and profits, which could have a material adverse impact on our business,

financial conditions and operations.

Our performance tracked by our Environmental, Social and Governance metrics is subject to risks and the outcomes

may not achieve the anticipated benefits or align with new regulations and stakeholders’ expectations.

There has been an increasing focus from stakeholders and regulators relating to environmental, social and governance

(ESG) matters across all industries in recent years. The standards and stakeholder expectations continue to evolve and

criteria to evaluate ESG practices may change rapidly. We are subject to evolving rules, including the European Union’s

Corporate Sustainability Reporting Directive (CSRD). We may also be subject to other U.S. state specific legislation,

such as California’s recently enacted climate disclosure laws, which will require in-scope companies to report on

greenhouse gas emissions, climate-related financial risks, and the use of carbon offsets and emissions reduction claims

relating to their cooperate operations or products. The future of the California climate disclosure law is uncertain, and

two of three are subject to ongoing litigation. The CSRD increases the depth of required disclosures. The specific

information required to be reported on is set out in the European Sustainability Reporting Standards (ESRS).

The Dutch government is in the process of implementing the CSRD into Dutch legislation. In 2025, we published our

first CSRD report in alignment with the CSRD and the ESRS for the financial year 2024 and this year’s Annual Report

is the first time we have reported a more extensive set of prescribed ESG data points. Performance tracked by our ESG

metrics is also highly dependent on third-parties, such as our suppliers and CROs, that we do not control, which may

adversely affect our reputation.

In response to new ESG initiatives and regulations we may voluntarily elect, or be required, to adopt strategies, policies,

or procedures related to ESG matters. Such efforts could divert management’s attention from central operational matters

and cause us to expend significant capital and human resources. Moreover, increasingly, different stakeholder groups

have divergent views on ESG matters, which increases the risk that any action or lack thereof with respect to

sustainability or ESG matters will be perceived negatively by at least some stakeholders and adversely impact our

business and reputation. The current sociopolitical landscape has led to rapid and unpredictable shifts in public

sentiment, which has resulted in dynamics that increase the risk of reputational damage, boycotts and shifts in consumer

behavior that could adversely affect our business and reputation. Reports could also lead to the disclosure of information

that may have a negative impact on our operations and reputation which may lead to additional exposure. Failure to

accurately comply with any sustainability reporting obligations may result in enforcement actions, sanctions, fines and

penalties, reputational harm or private litigation.

We may become exposed to liability and substantial expenses in connection with environmental compliance or

remediation activities.

Our operations, including our research, development, testing and third-party manufacturing activities, are subject to

numerous environmental, health and safety laws and regulations and for which we may become liable.

If we or one of our CMOs or third-party distributors, manufacturers, licensees or co-marketers fail to comply with such

laws and regulations, such failure could result in substantial fines, penalties or other sanctions which could also bring

significant reputational loss to our business.

We face a risk of environmental liability inherent in our current and historical activities, including liability relating to

releases of our exposure to hazardous or biological materials. Furthermore, environmental, health and safety laws and

regulations are becoming more stringent. Both us and our CMOs may be required to incur substantial expenses in

connection with future environmental compliance or remediation activities, in which case, our production and

development efforts may be interrupted or delayed, and our financial condition and results of operations may be

materially adversely affected.

Risk Factors Related to argenx’s Financial Position

We expect to increase our expenses for the foreseeable future, and we may not be able to raise additional capital, be

profitable or sustain net profitability in the future in order to fund our operations.

We intend to continue to conduct research and development, preclinical testing, clinical trials and regulatory compliance

activities as well as the continued commercialization of VYVGART and other products candidates, for current and future


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indications, and we intend to continue our efforts to expand our sales, marketing and distribution infrastructure. We

anticipate that our operating expenses will increase as we execute our strategic objectives and as we experience delays or

encounter issues relating thereto, including failed clinical trials, ambiguous clinical trial results, safety issues or other

regulatory challenges.

To be profitable or sustain net profitability in the future, we must succeed in commercializing products that generate

significant product net sales. Our future results of operations and profitability may fluctuate from period to period, and

we will need to generate significant revenues to be profitable or sustain net profitability in the future. We may not be

able to generate these revenues, and we may never achieve profitability on a sustained basis in the future. If we do not

succeed in sustaining profitability, we would not be able to use deferred tax assets against taxable profits which would

result in a de-recognition of our deferred tax asset balance.

To finance our operations, we may need to raise additional capital through a combination of public or private equity or

debt financings or other sources, which may include collaborations with third parties. Our ability to raise additional

funds on acceptable terms or at all will depend on financial, economic and market conditions and other factors, over

which we may have no or limited control. If we are unable to raise additional capital if and when needed, or if the terms

are not acceptable, our business strategy could be impacted, and we may be forced to delay, reduce or terminate one or

more of our research or development programs or the commercialization of any of our products or product candidates,

including new indications, or be unable to expand our operations or otherwise capitalize on our business opportunities,

all of which may have a material adverse impact on our business, financial condition and results of operations.

Our assets, earnings and cash flows and the investment of our cash and cash equivalents may be subject to risks

which may cause losses and affect the liquidity of these investments.

We invest our cash in accordance with an established internal investment policy. Currently, substantially all of our

available cash and cash equivalents and current financial assets are invested in either current accounts, savings accounts,

term accounts or highly liquid money market funds. Any future investments may include term deposits, corporate bonds,

commercial paper, certificates of deposit, government securities and money market funds in accordance with our cash

investment policy. These investments may be subject to general credit, liquidity, market, inflation, foreign currency and

interest rate risks and we may realize losses in the fair value of these investments or a complete loss of these

investments. The aforementioned risks associated with our cash flows and investment portfolio may adversely affect our

results of operations, liquidity and financial condition.

Due to the international scope of our operations, our assets, earnings and cash flows are influenced by movements in

exchange rates of several currencies, particularly the euro and Japanese Yen. Our revenue from outside of the U.S. will

increase as our products, whether commercialized by us or our business partners or our collaborators gain marketing

approval in such jurisdictions. If the U.S. dollar weakens against a specific foreign currency, our revenues will increase,

having a positive impact on net income, but our overall expenses will increase, having a negative impact. Conversely, if

the U.S. dollar strengthens against a specific foreign currency, our revenues will decrease, having a negative impact on

net income, but our overall expenses will decrease, having a positive impact. Continued volatility in foreign exchange

rates is likely to impact our operating results and financial condition.

Risk Factors Related to argenx’s Business and Industry

Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory

standards and requirements, or insider trading violations, which could significantly harm our business.

We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional

failures to comply with governmental regulations, comply with healthcare fraud and abuse and anti-kickback laws and

regulations in the U.S. and other markets, failure to report financial information or data accurately or disclose

unauthorized activities to us, among others. In particular, sales, marketing and business arrangements in the healthcare

industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and

other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting,

marketing and promotion, sales commission, customer incentive programs and other business arrangements. Employee

misconduct could also involve the improper use of material information, including improper trading based upon,

information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our

reputation. We maintain a global compliance program and remain focused on its evolution and enhancement. Our

program includes efforts such as risk assessment and monitoring, fostering a culture encouraging employees and third

parties to raise good faith questions or concerns, and defined processes and systems for reviewing and remediating

allegations and identified potential concerns. It is not always possible, however, to identify and deter employee

misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown

or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming

from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not


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successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business

and results of operations, including the imposition of significant fines or other sanctions.

We may become exposed to costly and damaging liability claims.

We are exposed to potential product liability and professional indemnity risks that are inherent in the research,

development, manufacturing, marketing and use of pharmaceutical products and marketing of human therapeutic

products. The current and future use of products and product candidates by us and our collaborators in clinical trials and

the sale of any approved products may further expose us to liability claims. If any of our products or product candidates

were to cause adverse side effects during clinical trials or after approval of the product candidate, we may be exposed to

substantial liabilities. These claims might be made by patients who use the product, healthcare providers, pharmaceutical

companies, physicians, payors, caregivers, investors, employees, government agencies, or our collaborators or others

selling such products. Physicians and patients may not comply with any warnings that identify known potential adverse

effects and patients who should not use our product candidates. Any claims against us, regardless of their merit, could be

difficult and costly to defend and could materially adversely affect the market for our products and product candidates or

any prospects for commercialization of our products and product candidates. Any such claims, regardless of their merit,

could also adversely affect our reputation and the trust that physician and patients place in our products.

Product liability risk in the EU will increase in the future once plaintiff-friendly reforms, such as Directive (EU)

2024/2853 (Product Liability Directive), take effect. The Product Liability Directive introduces claimant-friendly

changes. This includes, for instance, the expansion of the definition of “damage” (e.g. by including medically recognized

psychological harm), creating rebuttable presumptions as to defect and causation to help claimants prove their case (e.g.

if the claimant faces excessive difficulties to prove this due to scientific complexity) and abolishing minimum or

maximum financial thresholds for claims. The Product Liability Directive, like its predecessor, provides that claims shall

expire if the injured person does not initiate proceedings within ten years after the defective product was placed on the

market. However, it extends this longstop period to 25 years if this is due to the latency of the underlying personal

injury. Member States must transpose the Product Liability Directive into national law by December 2026.

Regardless of the merits or eventual outcome, litigation or liability claims may result in:

•decreased demand for our products due to negative public perception;

•damage to our reputation;

•withdrawal of clinical trial participants or difficulties in recruiting new clinical trial participants;

•initiation of investigations by regulators;

•costs to defend or settle the related litigation;

•a diversion of management’s time and our resources;

•substantial monetary awards to clinical trial participants or patients;

•product recalls, withdrawals or labeling, marketing or promotional restrictions;

•loss of revenues from product sales; and

•the inability to successfully commercialize our product candidates, if approved.

Although we maintain product liability insurance, we may not be able to maintain insurance coverage at a reasonable

cost or to obtain adequate insurance coverage to satisfy any liability that may arise. Product liability claims could delay

or prevent completion of our clinical development programs. In addition, claims made by patients, healthcare

professionals or others might not be fully covered by product liability insurance and could result in investigations of the

safety of our products or product candidates or may result in recalls. If a successful product liability claim or series of

claims is brought against us for uninsured liabilities or in excess of insured liabilities, our assets may not be sufficient to

cover such claims and our business, financial condition and results of operations would be adversely affected.

In the ordinary course of business we may also face substantial, complex or extended litigation that could cause us to

incur significant costs and distract our management. This is especially relevant for biopharmaceutical companies. Such

litigation or proceedings could substantially increase our operating expenses and could adversely affect our business.

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We may engage in strategic transactions, including acquisitions, collaborations, licenses or investments in other

companies or technologies, and we may not realize the benefits of such transactions.

We may enter into strategic transactions, including acquisitions, collaborations, licenses or investments for or in other

companies or technologies that complement or augment our existing business and facilitate our access to new products,

research projects or geographical areas. However, we may not be able to identify appropriate targets or enter into such

transactions under satisfactory conditions. In addition, we may need additional funding to finance these transactions

including through issuances of public or private equity or convertible debt securities, which could be dilutive to our

shareholders and ADS holders.

Integrating any newly acquired companies, business, technologies or products could be expensive, time-consuming, and

may never be successful. Integration efforts often take a significant amount of time, place a significant strain on

managerial, operational and financial resources, result in loss of key personnel and could prove to be more difficult or

expensive than we predict. The diversion of our management’s attention and any delay or difficulties encountered in

connection with any future transactions we may consummate could result in the disruption of our ongoing business or

inconsistencies in standards and controls that could negatively affect our ability to maintain third-party relationships. We

cannot assure that we will achieve the expected synergies to justify any such transaction, which could have a material

adverse effect on our business, financial condition, results of operations and future growth prospects and our investors’

ability to realize on their investment.

Our business and operations could suffer in the event of system failures or unauthorized or inappropriate use of or

access to our systems.

We are increasingly dependent on our information technology systems and infrastructure for our business. We collect,

store and transmit sensitive information including intellectual property, proprietary business information, including

highly sensitive clinical trial data, and personal data in connection with business operations. The secure maintenance of

this information is critical to our operations and business strategy. Some of this information could be an attractive target

of criminal attack or unauthorized access and use by third parties with a wide range of motives and expertise, including

organized criminal groups, “hacktivists”, patient groups, disgruntled current or former employees and others. Cyber-

attacks are of ever-increasing levels of sophistication, and despite our security measures, our information technology and

infrastructure may be vulnerable to such attacks or may be breached, including due to employee error or malfeasance.

Although we are making significant efforts to maintain the security and integrity of our information systems and are

exploring various measures to manage the risk of a security breach or disruption, there can be no assurance that our

security efforts and measures will be effective or that attempted security breaches or disruptions would not be successful

or damaging. Despite the implementation of security measures, our internal computer systems and those of our

contractors and consultants are vulnerable to damage or interruption from computer viruses, unauthorized or

inappropriate access or use, natural disasters, pandemics, terrorism, war (including the ongoing conflict in Ukraine and

the ongoing conflict in Israel and the Gaza Strip), and telecommunication and electrical failures. For example, the loss of

pre-clinical trial data or data from completed or ongoing clinical trials for our product candidates could result in delays in

our regulatory filings and development efforts, as well as delays in the commercialization of our products, and

significantly increase our costs. To the extent that any disruption, security breach or unauthorized or inappropriate use or

access to our systems were to result in a loss of or damage to our data, or inappropriate disclosure of confidential,

personal or proprietary information, we could incur notification obligations to affected individuals and government

agencies, liability, including potential lawsuits from patients, collaborators, employees, stockholders or other third

parties and liability under foreign, federal and state laws that protect the privacy and security of personal data, and the

development and potential commercialization of our product candidates could be delayed.

Not all of our contracts contain limitations of liability, and even where they do, there can be no assurance that limitations

of liability in our contracts are sufficient to protect us from liabilities, damages or claims related to our data privacy and

security obligations. We cannot be sure that our insurance coverage will be adequate or sufficient to protect us from or to

mitigate liabilities arising out of our privacy and security practices.

We are highly dependent on public perception of our products.

We are highly dependent upon consumer perceptions of the safety and quality of our products. We could be adversely

affected if we, or any of our collaborators, are subject to negative publicity or if any of our products or any similar

products distributed by other companies prove to be, or are asserted to be, harmful to patients, or for example, be deemed

cruel to animals. In addition, if patients have negative perceptions of our products and our competitors are successful in

developing biosimilar or interchangeable products for our products and product candidates, patients may choose the

other biosimilar or interchangeable products sold by our competitors. Because of our dependence upon consumer

perception, any adverse publicity associated with illness or other adverse effects resulting from patients’ use or misuse of


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our products or any similar products distributed by other companies, or adverse results reported by us, our collaborators

or other companies relating to clinical studies may subject our products to class warnings or negatively impact our public

perception of our products and product candidates, which could have a material adverse impact on our business,

prospects, financial condition and results of operations.

Risk Factors Related to argenx’s Intellectual Property

We may be unable to adequately maintain, enforce or protect our intellectual property rights in products, product

candidates and platform technologies which could adversely affect our ability to maximize the value for patients in

our marketed products and product candidates.

Our commercial success depends in part on obtaining and maintaining patents and other forms of intellectual property

rights for our products, product candidates and platform technologies. Failure to obtain, maintain, enforce, protect, or

extend adequate patent and other intellectual property rights, which can be challenging and costly, could adversely affect

our ability to develop and market our products and product candidates and reduce any competitive advantage we may

have.

We cannot be certain that patents will be issued or granted with respect to applications that are currently pending and we

may not be the first to file patent applications related to our product candidates and products. The scope of patent

protection that the European Patent Office and the USPTO will grant with respect to products in our product pipeline is

uncertain and may vary. It is possible that the European Patent Office and USPTO will not allow broad claims that cover

molecules closely related to our products and product candidates as well as the specific molecule and competitors may

be free to market substantially similar molecules if granted approval, thereby reducing our market potential. We and our

current or future licensors, licensees or collaboration partners may not be able to prepare, file, prosecute and maintain all

necessary or desirable patent applications at a reasonable cost or in a timely manner. Our current and future licensors’,

licensees’ or collaboration partners’ ability to ensure the issuance, scope, validity, enforceability and commercial value

of licensed technology is uncertain and we may need to rely on them to obtain costly additional IP licenses. Additionally,

such parties may not fully comply with applicable patent rules or laws, which could result in loss of patent rights, or such

parties may disagree with us as to the strategy for prosecution, maintenance or enforcement of any such patent rights.

Filing, prosecuting, and defending patents on product candidates in all jurisdictions throughout the world would be

prohibitively expensive and the laws of certain jurisdictions may not protect our rights to the same extent as the laws of

the U.S., UK or EU. We may face difficulties in enforcing patent rights in the future, including in certain jurisdictions

where we have not yet filed patent applications.

Competitors may use our and our licensors’ or collaboration partners’ technologies in jurisdictions where we have not

obtained patent protection, or where broad research exemptions are available, to develop their own products and may

export otherwise infringing products to territories where we, our licensors or collaboration partners have patent

protection, but where enforcement is not as strong as that in the U.S., UK and the EU. In such cases, we would have little

effective recourse to prevent such products from competing with ours.

In addition, some countries have compulsory licensing laws under which a patent owner may be compelled to grant

licenses to third parties, and other countries limit the enforceability of patents against government agencies or

government contractors. In these countries, the patent owner may have limited remedies, which could materially

diminish the value of such patent.

Intellectual property litigation could lead to substantial resource diversion or issued patents could be found invalid,

not infringed, or unenforceable if challenged in the applicable patent office or court.

Our patents may remain open to invalidity challenges after allowance or grant, whereby third parties can challenge the

scope or validity of such granted patent. In the course of such proceedings, we may be compelled to limit the scope of

patent claims thus challenged or may lose the claims altogether.

We may elect to initiate adversarial proceedings in order to enforce or defend any intellectual property rights owned by

or licensed to us, or to determine or challenge the scope or validity of intellectual property rights of third parties to

protect our competitive position. We may need to divert substantial time and resources to the enforcement and protection

of our or our collaboration partners’ intellectual property rights. In addition, the outcomes are uncertain and any

remedies or damages awarded may not be meaningful. An adverse ruling of non-infringement, limiting claim scope, or

invalidating one or more of our issued patents could allow third parties to commercialize our products after the

expiration of our market exclusivity or use our platform technologies to compete directly with us, without payment to us.

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We may be subject to claims challenging the inventorship or ownership of our intellectual property or be required to

make additional payments to secure intellectual property from collaborators.

Many of our consultants and employees, including in the senior management team (consisting of our CEO and senior

personnel reporting directly to the CEO) (Senior Management Team), were previously employed at other competing or

potentially competing biotechnology or pharmaceutical companies and some have executed proprietary rights, non-

disclosure and non-competition agreements in connection with such previous employment. Although we take measures

to ensure third parties, consultants and employees do not use such proprietary information in their work for us, we may

be subject to claims that we or these consultants and employees have improperly used or disclosed confidential

information or intellectual property of their former employer.

Additionally, many of our collaborators do not commit to assigning all intellectual property arising out of our

collaborations to us and, instead, grant us options to acquire intellectual property or commit to making such intellectual

property available to us at a fair price. As such, we may be required to make additional payments to secure valuable

intellectual property rights under our existing collaborations or become subject to inventorship disputes.

In addition, although we take steps to ensure that our collaborators do not use our intellectual property rights other than

for the purposes of our collaboration, there may be instances where former or current collaborators or other third parties

nevertheless apply for or obtain patent protection for inventions to which we believe we have rights, in whole or in part.

In such cases, we may elect to assert our ownership of such intellectual property. There is no guarantee that we will be

successful in asserting such claims.

In addition, while it is our policy to require our employees and contractors who may be involved in the development of

intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in

ensuring effective assignment of intellectual property under such agreements. Our assignment agreements may not be

self-executing, or may be breached, and we may be forced to bring or defend against claims to assert ownership of such

intellectual property. There is no guarantee we will be successful in pursuing such claims, which could result in us

paying monetary damages or losing valuable personnel or intellectual property rights.

Third-party intellectual property rights could adversely affect our ability to commercialize our products and product

candidates.

Our competitive position may suffer if valid and enforceable third-party intellectual property rights cover our products,

product candidates, manufacturing processes, or those of our partners. In such cases, our freedom to develop or

commercialize products or product candidates may require obtaining a license, designing around third party intellectual

property rights with significant time and materials costs, or invalidating the third party rights. If our products are found

to infringe a valid and enforceable patent claim, we and our partners could be prevented from continuing to develop or

commercialize the affected product without an appropriate license, which may be costly or unavailable on commercially

reasonable terms, if at all. Similarly, other companies may have filed patent applications or have patents directed toward

similar targets for certain of our products and we may not be aware of unpublished pending patent applications or patent

applications that are amended to cover our products or platform technologies.

Even if we or our partners can obtain the appropriate license, it may be non-exclusive, thereby providing our competitors

with opportunity to access the same licensed technology. If the breadth and scope of protection provided by our or our

partners’ patents, licensed patents or patent applications is threatened or limited, it could dissuade companies from future

collaborations with us to license, develop or commercialize products and product candidates which would have an

adverse effect on our competitive business position.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation,

some of our confidential information could be disclosed in any such proceedings.

We may not be successful in obtaining or maintaining necessary rights to our products and product candidates

through acquisitions and in-licenses.

We may be unable to acquire or in-license third-party intellectual property rights necessary or useful for development or

commercialization of our product, product candidates or technology. We sometimes collaborate with U.S. and non-U.S.

academic institutions and typically receive an option to negotiate a license to the institution’s proprietary interest in any

collaboration technology. However, we may be unable to successfully negotiate such license and the institution may

offer such intellectual property rights to third parties thereby blocking our ability to pursue the applicable program.

In addition, our competitor companies may be unwilling to license desirable or necessary intellectual property rights to

us, or we may be otherwise unable to license or acquire other third party intellectual property rights on commercially


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reasonable terms which could negatively impact current development or hinder our ability to pursue development of new

programs.

Under our existing licenses, failure to comply with our obligations thereunder could result in termination of such

licenses, thereby limiting our ability to develop and commercialize products covered by such licensed technology.

Moreover, despite our efforts to comply with our contractual obligations, our licensors could conclude we have

materially breached any such agreement and we could incur significant costs and disruption to our business defending

against any breach alleged by the licensor.

Moreover, several of our existing license agreements are sub-licenses from third parties. We have little control if our

licensors fail to comply with their obligations under their upstream license agreements, whereby the original third-party

licensor may have the right to terminate the original license and possibly our sub-license. In such cases, we may not be

able to procure a direct license covering such intellectual property possibly materially affecting our ability to develop

and commercialize certain products and product candidates.

If our brand protection strategies, including the filing, prosecution and enforcement of trademarks and trade names,

are not adequately executed, we may not be able to build name recognition for approved products in our markets of

interest in line with our strategic priorities.

Third parties may seek to oppose, attempt to cancel our trademark applications, or challenge, infringe or circumvent our

registered and unregistered trademarks, including through counterfeiting of our products. In the event that our

trademarks are successfully challenged, we may not be able to use these trademarks to continue to effectively market our

branded products and could be forced to rebrand them, which could result in loss of their brand recognition or require us

to devote resources to develop new brand profiles. Such efforts could also hinder our efforts to commit to and deliver on

strategic internal initiatives.

If we attempt to enforce our trademarks or assert trademark infringement claims, a court may determine that our

trademarks are invalid or unenforceable or that the party against whom we have asserted trademark infringement has

superior rights with respect to such marks. If we are unable to establish name recognition and adequately protect and

enforce our trademark portfolio, we may not be able to compete effectively in the market or build brand recognition for

new products globally.

We may not be able to obtain protection under the U.S. Drug Price Competition and Patent Term Restoration Act of

1984 (Hatch-Waxman Act) and similar non-U.S. legislation for extending the term of patents covering each of our

products and product candidates.

Depending upon the timing, duration and conditions of FDA marketing approval of our product candidates, one or more

of our U.S. patents may be eligible for limited patent term extension under the Hatch-Waxman Act and similar

legislation in the EU and the Asia Pacific region. However, the patent term extension under the Hatch Waxman Act

cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, and only one

patent applicable to an approved drug may be extended.

In the EU, the term of a patent for a medicinal product can be extended by a supplementary protection certificate (SPC),

but not beyond a maximum of five years (except for patents for products for pediatric use, for which the term can be

extended by a further six months). However, products containing a compound for which an SPC has already been

granted are not eligible for SPC protection. Therefore, we will not be able to extend the term of a patent relating to a

medical compound for which an SPC has already been granted, even if the patented product relates to a different medical

use of that compound.

If we are unable to obtain patent term extension, the term of any such extension is less than we request, or the statutes

governing patent term extension are amended to reduce the term of such extensions, our patent exclusivity for that

product will be shortened and our competitors may obtain approval to market competing products sooner than we expect.

Changes in patent laws or patent jurisprudence could diminish the value of patents in general thereby impairing our

ability to protect our products.

Changes in patent law across jurisdictions, or changes in any relevant government’s enforcement procedure may weaken

our ability to obtain new patents or to enforce rights in our owned and licensed patents. For example, the U.S. Supreme

Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in

certain circumstances or weakening the rights of patent owners in certain situations. Relatedly, the U.S. Congress is

considering multiple draft bills that, if passed, may have a significant impact on U.S. patent laws. Any such changes by


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the U.S. Congress or U.S. courts and the relevant law-making bodies in other countries may materially affect our patents

or patent applications and we cannot predict the effects of future changes in patent law.

We may be unable to protect the confidentiality of our trade secrets and their disclosure to competitors, harming our

market position.

In addition to patent protection, we rely on trade secret protection for our proprietary information, including, for

example, certain aspects of our llama immunization and antibody affinity maturation approaches. However, while we

take appropriate measures to prevent misappropriation of our trade secrets and restrict access to them internally, trade

secrets are difficult to protect. Despite requiring our licensors, collaborators, suppliers, consultants and advisors to

execute confidentiality agreements, we cannot fully protect against willful or inadvertent unauthorized disclosure of our

trade secrets by such counterparties to competitors, and we may not be able to secure adequate legal or equitable

remedies to prevent our competitors from using these trade secrets. Any such disclosure, whether willful or inadvertent,

could enable our competitors to duplicate or build upon our technology.

In addition, enforcing a claim that a third party unlawfully misappropriated trade secrets is expensive, time-consuming

and the outcome is unpredictable, and the enforceability of the underlying confidentiality agreements protecting these

trade secrets may vary across jurisdictions. Further, if any of our trade secrets were to be lawfully obtained or

independently developed by a competitor or other third party, they could use such technology to compete with us.

Risk Factors Related to argenx’s Organization and Operations

Our future growth and ability to compete depends on maintaining our culture, retaining our key personnel and

recruiting additional qualified personnel.

We believe that our corporate culture has been, and will continue to be a key contributor to our success. However, as we

continue to grow and evolve, our ability to foster our key values - innovation, co-creation, empowerment, excellence and

humility that we believe are important to support our growth - may be impacted. For example, investors, regulators,

customers, employees and other stakeholders continue to focus on ESG matters, including in workforce policies and

initiatives and we may not be able to meet the different expectations and demands of all our stakeholders in that respect,

which could result in adverse publicity, harm our reputation and negatively impact our ability to attract, retain and

motivate qualified employees and our future success. As we implement more complex organizational structures, and

increase our headcount to support the growth in our business, we may find it increasingly difficult to maintain the

beneficial aspects of our corporate culture, which could similarly negatively impact our ability to attract, retain and

motivate qualified employees and our future success.

As a global organization in a highly competitive and specialized industry, our success also depends upon the continued

contributions of our key management, scientific, medical and technical personnel, many of whom have been

instrumental for us and have substantial experience with our product and related technologies. These key management

individuals include the members of the Board of Directors and Senior Management Team. Difficulties in recruiting or

the loss of key managers, scientific, medical or technical personnel could delay our research and development activities.

In addition, it may be difficult to attract and retain highly qualified management, scientific and medical personnel,

particularly if we expand into fields that will require additional skills.

As a Dutch company listed on Euronext Brussels in addition to Nasdaq, our remuneration practices and policies may be

limited by local governance rules or shareholder guidance for EU companies. Such limitations may make it more

difficult to successfully compete for key talent in a number of markets with differing remuneration practices and policies

compared to our competitors. For example, the Dutch Corporate Governance Code 2022 (DCGC) places certain

limitations on the ability to grant equity incentives to Non-Executive Directors, while Belgian law requires Non-

Executive Directors to receive part of their remuneration in the forms of shares, but not stock options. The DCGC also

places limitations on amount of severance payment permitted in the event of dismissal.

Many other biotechnology and pharmaceutical companies and academic institutions that we compete against for

qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry

than we do. Additionally, an inflationary environment, combined with the tight labor market for the recruitment and

retention of skilled workers, could make it more costly for us to attract or retain employees. In order to meet the

compensation expectations of our prospective and current employees due to inflationary factors, we may be required to

increase our operating costs. Therefore, we might not be able to attract or retain these key persons on conditions that are

economically acceptable.

Global geo- and socio-political threats and macro-economic uncertainty and other unforeseen political crises could

materially and adversely affect our business and financial performance.


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Many geo- and socio-political threats and macro-economic uncertainties are outside of our control and could adversely

affect consumer confidence and disposable income levels, increase difficulty in forecasting our financial results and have

other impacts on our business and financial performance. Such geo- and socio-political threats could also result in

volatility in stock markets in general, causing our stock to have extreme price and volume fluctuations unrelated to our

business and financial performance. Such geo- and socio-political threats and uncertainties include:

•general economic and market conditions, including instability resulting from inflationary pressures, increasing

interest rates and the ongoing Russia-Ukraine and Middle East conflicts;

•geopolitical events, including natural disasters, public health issues (including pandemics), acts of war (such as the

Russia-Ukraine and Middle East conflicts), and terrorism;

•economic and trade sanctions, import and export regulations, customs, outbound investment

•restrictions, changes in trade agreements, trade barriers or other restrictions on foreign trade, and changes in trade

regulations and restrictions, including between the U.S. and other countries;

•global or regional economic conditions that impact companies and customers with which we do business;

•political or social unrest, economic instability, repression, or human rights issues;

•disruptions in supply chains;

•risks related to other government regulation or required compliance with local laws; and

•consumer and commercial credit availability, unemployment, and consumer debt levels;

•local licensing and reporting obligations.

Due to our international operations and the fact that we run clinical trials in a large number of jurisdictions, the eruption

of global conflicts may negatively impact our ability to conduct or complete clinical trials in the affected regions, which

could adversely affect our business and financial performance. For example, on June 12, 2024, the U.S. Department of

the Treasury’s Office of Foreign Assets Control issued General License 6D to replace General License 6C. General

License 6D authorizes “clinical trials and other medical research activities” that would otherwise be prohibited by U.S.

sanctions targeting Russia, and General License 6D does not have an expiration date. Additionally, the conflict between

Russia and Ukraine and the sanctions imposed upon Russia by the U.S., the UK, and the EU, among others could have a

material adverse impact on our business, financial conditions and operations. The sanctions and export controls

landscape is evolving and may change unexpectedly at any time.

We also perform development activities in a number of countries exposed to geopolitical risk and if conflicts in those

countries were to escalate further and impact neighboring countries, it could impact our development activities in those

countries.

Changes in U.S.-Mainland China relations, including tariffs, export controls, sanctions, and other regulations may

adversely impact our collaboration with Zai Lab in Mainland China, Hong Kong, Taiwan and Macau (together, Greater

China). The U.S. government has taken steps and continues to take steps with regard to U.S.-Mainland China relations

that will impact companies with connections to the U.S. or Mainland China, including by imposing tariffs affecting

certain products manufactured in Mainland China, imposing certain sanctions on individuals and entities in the Mainland

China, and issuing statements indicating enhanced review of companies with significant Mainland China-based

operations. The U.S. government may pass laws that could potentially severely restrict our ability to contract with certain

Chinese biotechnology companies without losing our ability to contract with or receive funding from the U.S.

government. Such restrictions could have an adverse impact on our operations.

Several countries are considering or have implemented tariffs, trade barriers or restrictions, as well as other measures

impacting cross-order commerce, which could negatively affect our business, financial conditions and results of

operations, including by negatively impacting our revenues from product sales or our cost of goods sold. The U.S.

federal government has implemented tariffs on certain foreign goods and may implement additional or revised tariffs in

the future. Such actions could give rise to an escalation of trade measures by the U.S. and impacted countries.

Developments with regard to the timing and manner in which tariffs will be implemented; the amount, scope, and nature

of tariffs; the countries subject to new or additional tariffs imposed by the U.S.; tariffs imposed by other countries on

goods imported from the U.S.; and other wide-ranging retaliatory measures are rapidly evolving and may change

unexpectedly at any time.


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Any new legislation, executive orders, tariffs, export controls, sanctions and/or other regulations that may be

implemented, any unfavorable government policies on international trade, including tariffs and export controls, the

renegotiation of existing trade agreements, any increased scrutiny on companies with significant Mainland China-based

operations, and any retaliatory actions taken by the U.S., EU, Chinese or other governments due to trade tensions could

have an adverse effect on our business, including the development and commercialization of products containing argenx-

licensed material. Further, general political uncertainty may have an adverse impact on our business, financial condition

and results of operations. For example, significant political events in the U.S. may cast uncertainty on global financial

and economic markets, especially following the recent U.S. presidential election.

We face risks related to natural disasters and public health issues, that could negatively affect our business and

financial condition.

Our business could be adversely impacted by the effects of catastrophic global events including natural disasters such as

earthquakes, fires, hurricanes, tornados, floods or significant power outages and public health crises, such as the

COVID-19 pandemic.

For example, the manufacturing of all of our products and product candidates requires using cells which are stored in a

cell bank. We have one master cell bank for each product manufactured in accordance with cGMPs. However, it is

possible that we could lose multiple cell banks and have our manufacturing significantly impacted by the need to replace

these cell banks, which could materially adversely affect our business, prospects, financial condition and results of

operations. Public health issues could also negatively affect our business and financial condition. We operate and

conduct our clinical trials globally. We cannot presently predict the scope and severity of any potential future business

shutdowns or disruptions as a result of public health issues. If we or any of the third parties with whom we engage,

including the suppliers, contract manufacturers, clinical trial sites, regulators and other third parties, were to experience

shutdowns, quarantines, or other business disruptions due to natural disasters or global public health issues, it may

impair our or our third-party partners’ ability to initiate clinical trials and recruit and retain patients, particularly if

quarantine or travel restrictions impede healthcare provider or patient movement, impact the usability of the data due to

treatment interruptions and require protocol amendments. In addition, regulatory authorities may restrict their operations

or be delayed in their operations during a pandemic, the outbreak of new variants or other public health issues, including

further to travel restrictions which could adversely affect our ability to obtain regulatory approval for and to

commercialize our products and product candidates and have a material adverse effect on our business and financial

results.

We are exposed globally to unanticipated changes in tax laws and regulations, adjustments to our tax provisions,

exposure to additional tax liabilities, or adjustments of our tax assets.

As a company active in research and development, we have benefited from certain research and development tax

incentives including tax credits and a payroll withholding tax exemption. We also expect to benefit from the Belgian

innovation income deduction.

The determination of our provision for income taxes and other tax liabilities requires judgment, including the adoption of

certain accounting policies and our determination of whether our deferred tax assets are, and will remain, fully available

in future periods. We cannot guarantee that our interpretation of applicable tax laws (including with respect to our

eligibility for, or our calculation of, tax incentives such as the Belgian R&D tax credit, the Belgian payroll withholding

tax exemption for R&D personnel, the Belgian innovation income deduction and similar tax incentives in other

jurisdictions in which we have material operations or sales), our transfer pricing policies or our organizational and

operational structure will not be questioned by the relevant tax authorities, or that the relevant tax laws and regulations,

or the interpretation thereof, including through tax rulings, will not be subject to change. Our effective tax rates could be

adversely affected, now or in the future, by changes in tax laws, treaties and regulations or the interpretation thereof by

the relevant tax authorities in countries where we have material operations. A successful challenge to tax positions in

Belgium or other country where we have material operations may lead to adjustments in the amounts recorded in our

financial statements and could have a significant impact on our effective tax rate and on our deferred tax assets. An

increase of the effective tax rates could have an adverse effect on our business, financial position, results of operations

and cash flows.

In 2021, the Organisation of Economic Co-operation and Development (OECD) published a proposal that included a

global minimum tax (Pillar Two). To date, many jurisdictions are in various stages of implementation of Pillar Two

rules.

Based on current information, management expects that the Company will be subject to the Pillar Two Directive and

domestic laws in 2025, as it is the year the Company has met all requirements under the Pillar Two legislation. The

Company does not expect the Pillar Two rule to have a material impact on the effective tax rate of the Group.


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In case of a change of control, we could be exposed to the risk of losing any unused tax credit and innovation income

deduction. Furthermore, if any legislator decides to eliminate, or change the conditions for claiming such tax incentives,

or reduce the scope or the rate of such incentives, any of which it could decide to do at any time, our results of operations

could be adversely affected including through the de-recognition of deferred tax assets.

We may encounter difficulties efficiently managing our growth and our increasing development, regulatory, and sales

and marketing capabilities, which could disrupt our operations.

We have grown, and expect to continue to grow, significantly in the number of employees and scope of operations over

recent years, particularly in the areas of drug research, drug development, regulatory affairs, and sales and marketing. To

manage our anticipated future growth, we must continue to implement and improve our managerial, operational and

financial systems, expand our facilities and continue to recruit and train additional qualified personnel. In particular, we

must efficiently leverage our own sales and marketing capabilities in order to launch or market our products candidates

effectively.

Due to our limited financial resources and the limited experience of our management team in managing a company with

such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train

additional qualified personnel. Our limited financial, manufacturing and management resources, could cause us to forgo

or delay the pursuit of opportunities with potential product candidates that later prove to have greater market potential,

fail to capitalize on viable commercial products or profitable market opportunities or relinquish rights to such product

candidates through collaborations, licensing or royalty arrangements in circumstances where it would have been more

advantageous for us to retain sole development and commercialization rights. Any inability to manage growth could

delay the execution of our strategic objectives or disrupt our operations, which in turn could materially harm our

business and prospects.

Risk Factors Related to the ADSs

Holders of our ADSs have fewer rights than our ordinary shareholders.

Except as described in this Annual Report or any deposit agreements, holders of ADSs are not treated as our

shareholders unless they withdraw the ordinary shares underlying their ADSs in accordance with the deposit agreement

and applicable laws and regulations. The depositary, or its nominee, is the holder of the ordinary shares underlying the

ADSs. ADSs are transferable on the books of the depositary. The depositary may refuse to deliver, transfer or register

transfers of ADSs. Temporary delays in the cancellation of ADSs and withdrawal of the underlying ordinary shares may

arise. In addition, ADS holders may not be able to cancel their ADSs and withdraw the underlying ordinary shares when

they owe money for fees, taxes and similar charges and when it is necessary to prohibit withdrawals in order to comply

with any laws or governmental regulations that apply to ADSs or to the withdrawal of ordinary shares or other deposited

securities.

Holders of ADSs may vote them in person or by proxy in accordance with applicable laws and regulations and our

articles of association (Articles of Association). We cannot guarantee that holders of ADSs will receive the voting

materials in time to ensure that they can instruct the depositary to vote the ordinary shares underlying their ADSs.

Holders of our ADSs may not be able to exercise their right to give voting instructions or to vote in person or by proxy

and they may not have any recourse against the depositary or us if their ordinary shares are not voted as they have

requested or if their shares cannot be voted.

The price of our ADSs may be volatile and may fluctuate due to factors beyond our control. An active public trading

market may not be sustained.

The stock markets in general, and biopharmaceutical companies in particular, have experienced extreme price and

volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.

The trading price of our ADSs depends on a number of factors, including those described elsewhere in this “Risk

Factors” section, many of which are beyond our control and may not be related to our operating performance, which may

limit or prevent investors from readily selling their ADSs or ordinary shares and may otherwise negatively affect the

liquidity of our ADSs and ordinary shares. We provide guidance regarding our cash and expenses, which are inherently

uncertain. Any guidance that we provide may not always be accurate or may vary. If we fail to meet our guidance, or if

we have to revise such guidance, the price of our ADSs or ordinary shares could decline. Sales of a substantial number

of ADSs or our ordinary shares in the public market, or the perception that these sales might occur, could depress the

market price of ADSs or our ordinary shares and could impair the market price of our securities or our ability to raise

capital through the sale of additional equity securities.


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In addition, an active public trading market for our ADSs may not be sustained. Further, fluctuations in exchange rates

may also impact the price of our ADSs and ordinary shares which may result in heavy trading by investors seeking to

exploit such differences, or impact the proceeds holders receive.

If securities or industry analysts cease coverage of us, or publish inaccurate or unfavorable research about our

business, the price of our ADSs or ordinary shares and our trading volume could decline.

The trading market for the ADSs and ordinary shares depends in part on the research and reports that securities or

industry analysts publish about us or our business. We do not have control over these analysts. If no or too few securities

or industry analysts cover us, the trading price of our ADSs and ordinary shares would likely be negatively affected. If

one or more of the analysts who cover us downgrade our ADSs or ordinary shares or publish inaccurate or unfavorable

research about our business, the price of our ADSs or ordinary shares would likely decline.

If we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our

ability to comply with applicable regulations could be impaired, and the trading price of our ADSs may be negatively

impacted.

We are required to comply with various corporate governance and financial requirements under the Sarbanes-Oxley Act

of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing rules of the Nasdaq Global

Market (the Nasdaq listing Rules) and requirements, and other applicable securities rules and regulations. We are

required to furnish a report by management on, among other things, the effectiveness of our internal control over

financial reporting and an attestation report on internal control over financial reporting issued by our independent

registered public accounting firm. Undetected material weaknesses in our internal controls could lead to financial

statement restatements and require us to incur the expense of remediation. Moreover, any failure to maintain internal

control over financial reporting or any material weaknesses or significant deficiency thereover, could result in a loss of

investors’ in the accuracy, completeness and reliability of our financial statements, subject us to sanctions or

investigations, or negatively impact the trading price of our ADSs or ordinary shares.

Risk Factors Related to being a Foreign Private Issuer or a Dutch Company

The risks in this subsection that relate to our status as a foreign private issuer will change if we lose our status as a

foreign private issuer under U.S. law.

We are a Dutch European public company with limited liability. The rights of our shareholders may be different from

the rights of shareholders in companies governed by the laws of U.S. jurisdictions.

We are a Dutch European public company with limited liability (Societas Europeae ). The rights of shareholders and the

responsibilities of members of our Board of Directors may be different from the rights and obligations of shareholders in

companies governed by the laws of U.S. jurisdictions.

As a result of these differences between Dutch corporate law and our Articles of Association, on the one hand, and the

U.S. federal and state laws, on the other hand, in certain instances, our shareholders and holders of our ADSs could

receive less protection than they would as shareholders or ADS holders of a listed U.S. company.

For example, provisions of our Articles of Association may make it more difficult for a third party to acquire control of

us or effect a change in our Board of Directors. We have adopted several provisions that may have the effect of making a

takeover of our Company more difficult or less attractive. These provisions could discourage potential takeover attempts

that other shareholders may consider to be in their best interest and could adversely affect the market price of our

securities.

Holders of our ordinary shares outside the Netherlands, and holders of ADSs may not be able to exercise pre-emptive

rights or preferential subscription rights, respectively.

In the event of an increase in our share capital, holders of our ordinary shares are generally entitled under Dutch law to

full pre-emptive rights, unless these rights are excluded either by a resolution of the shareholders at a General Meeting,

or by a resolution of the Board of Directors (if the Board of Directors has been designated by the shareholders at a

General Meeting for this purpose).

However, making pre-emptive rights available to holders of ordinary shares or ADSs representing ordinary shares also

requires compliance with applicable securities laws in the jurisdictions where holders of those securities are located,

which we may be unable or unwilling to do. In particular, holders of ordinary shares or ADSs located in the U.S. would

not be able to participate in a pre-emptive rights offering unless we registered the securities to which the rights relate

under the U.S. Securities Act of 1933, as amended (Securities Act) or an exemption from the registration requirements.


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In addition, ADS holders would not be able to participate in a pre-emptive rights offering unless we made arrangements

with the depositary to extend that offering to holders of ADSs, which we are not required to do.

Claims of U.S. civil liabilities may not be enforceable against us or the members of our Senior Management Team

and our Board of Directors.

A significant amount of our assets are located outside the U.S. The majority of the members of our Senior Management

Team and our directors are not U.S. residents and we do not have significant assets in the U.S. As a result, it may not be

possible, or more difficult, for investors to enforce against them or us in U.S. courts, including judgments predicated

upon the civil liability provisions of the U.S. federal securities laws. There are no treaties between the U.S. with either

the Netherlands or Belgium providing for the reciprocal recognition and enforcement of judgments, other than arbitration

awards, in civil and commercial matters. Consequently, a final judgment for payment given by a court in the U.S. based

on civil liability, whether or not predicated solely upon U.S. securities laws, would not automatically be recognized or

enforceable in the Netherlands or in Belgium unless the underlying claim was re-litigated before a Dutch or Belgian

court of competent jurisdiction. This will depend on the applicable Dutch or Belgian national rules. In addition, there is

doubt as to whether a Dutch or Belgian court would impose civil liability on us or the members of our management or of

our Board of Directors in an original action predicated solely upon the U.S. federal securities laws brought in a court of

competent jurisdiction against us, our management or directors.

As a foreign private issuer, we are exempt from various rules and regulations that a U.S. domestic public company

would be required to follow, including those requirements under U.S. securities laws and Nasdaq listing standards.

As a “foreign private issuer” defined in the SEC’s rules and regulations, we are not subject to all of the disclosure and

corporate governance requirements applicable to companies organized within the United States. For example, are exempt

from certain provisions of the U.S. Securities Exchange Act of 1934, as amended (Exchange Act), that are applicable to

U.S. domestic public companies. We are subject to Dutch laws and regulations with regard to such matters. While we

furnish quarterly unaudited financial information to the SEC on Form 6-K, the information we furnish to the SEC is less

extensive and less timely compared to that required to be filed with the SEC by U.S. domestic issuers.

As a foreign private issuer listed on Nasdaq, we are subject to corporate governance listing standards. However, we are

permitted to rely on home country governance requirements and certain exemptions thereunder. Certain of our corporate

governance practices may differ significantly from the Nasdaq corporate governance listing standards. These practices

may afford less protection to shareholders than they would enjoy if we complied fully with corporate governance listing

standards.

As a Dutch public company with limited liability, we are not obligated to, and do not comply with, all the best practice

provisions of the DCGC, which may affect shareholders’ rights. We are required to disclose in our annual report, filed in

the Netherlands, whether we comply with the provisions of the DCGC. If we do not comply with the provisions of the

DCGC (for example, because of a conflicting Nasdaq Listing Rule or otherwise), we must list the reasons for any

deviation from the DCGC in our annual report filed in the Netherlands.

We may lose our foreign private issuer status which would then require us to comply with the Exchange Act’s

domestic reporting regime and cause us to incur significant legal, accounting and other expenses.

In order to maintain our current status as a foreign private issuer, either (a) a majority of our ordinary shares must be

either directly or indirectly owned of record by non-residents of the U.S. or (b)(i) a majority of our executive officers or

directors may not be U.S. citizens or residents, (ii) more than 50% of our assets cannot be located in the U.S. and (iii) our

business must be administered principally outside the U.S. As of February 19, 2025, we believe at least 50% of our

outstanding ordinary shares were held by U.S. residents (assuming that all our ordinary shares represented by ADSs

were held by residents of the U.S.).

The regulatory and compliance costs to us as a U.S. domestic issuer may be significantly higher than those we incur as a

foreign private issuer. We also expect that if we were required to comply with the rules and regulations applicable to

U.S. domestic issuers, it would make it more difficult and expensive for us to obtain director and officer liability

insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage.

These rules and regulations could also make it more difficult for us to attract and retain qualified members of our Board

of Directors.

If we were to be classified as a passive foreign investment company for U.S. federal income tax purposes, this could

result in adverse U.S. tax consequences to certain U.S. holders.


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If the Company is classified as a passive foreign investment company (PFIC) for any taxable year, U.S. investors may be

subject to adverse U.S. federal income tax consequences described below under “Item 10.E Taxation — Certain Material

U.S. Federal Income Tax Considerations for U.S. Holders” The Company will be classified as a PFIC for U.S. federal

income tax purposes for any taxable year in which, taking into account a pro rata portion of the income and assets of

25% or more owned subsidiaries, either (i) at least 75% of its gross income consists of “passive income” or (ii) at least

50% of the average quarterly value of its assets is attributable to assets that produce, or are held for the production of,

passive income.

Based on our historic and anticipated operations, the composition of our income and the projected composition and

estimated fair market values of our assets, we do not believe that we were a PFIC for our most recent taxable year and do

not expect to be classified as a PFIC for the current taxable year or for the foreseeable future. However, our status as a

PFIC is a factual determination made on an annual basis, and we cannot provide any assurances regarding our PFIC

status for the current or future taxable years.

ITEM 4. INFORMATION ON THE COMPANY

A. HISTORY AND DEVELOPMENT OF THE COMPANY

Our legal and commercial name is argenx SE. We were incorporated under the laws of the Netherlands on April 25,

2008, as a private company with limited liability (besloten vennootschap met beperkte aansprakelijkheid). From

incorporation until August 28, 2009, our research and development activities were initially performed in the Netherlands,

then Belgium, by argenx N.V. and its legal predecessors. Since August 28, 2009, all our research and development

activities have been performed by our wholly-owned subsidiary, argenx BV, under a license provided by argenx N.V.

Throughout this time, argenx BV assigned all resulting intellectual property to argenx N.V. On May 28, 2014, we

converted to a Dutch public company with limited liability (naamloze vennootschap). On April 26, 2017, we converted

to a Dutch European public company with limited liability (Societas Europaea or SE). On May 5, 2017, we transferred

the legal ownership of all intellectual property rights of argenx SE to argenx BV, effective retroactively as of January 1,

2017. As a result, since January 1, 2017, (i) argenx BV holds all legal and economic ownership of our intellectual

property rights, and (ii) the research and development agreement between argenx SE and argenx BV has been

terminated.

Our official seat is in Amsterdam, the Netherlands, and our registered office is at Laarderhoogtweg 25, 1101 EB

Amsterdam, the Netherlands. We are registered with the trade register of the Dutch Chamber of Commerce under

number 24435214. Our European legal entity identifier number (LEI) is 7245009C5FZE6G9ODQ71. Our telephone

number is +31 (0) 10 70 38 441. Our website address is www.argenx.com. This website is not incorporated by reference

in this Annual Report. The SEC maintains an Internet site that contains reports, proxy and information statements, and

other information regarding issuers that file electronically with the SEC at www.sec.gov. The registered agent for service

of process in the U.S. is CT Corporation System, with an address at 111 8th Avenue, New York, NY 10011.

For information on our capital expenditure for the years ended December 31, 2024, 2023 and 2022, please see

“Note 4 — Property, Plant and Equipment” and “Note 5 — Intangible Assets” in our consolidated financial statements

which are appended at the end of this Annual Report on Form 20-F for the period ended December 31, 2024, and which

are incorporated herein by reference. We anticipate our capital expenditure in 2025 to be financed from the cash flows

from operating activities and cash reserves. For more information on our capital expenditures and requirements, see

“Item 5.B. — Liquidity and Capital Resources — Cash Flows — Operating and Capital Expenditure Requirements” in

our Annual Report for the period ended December 31, 2024 which is incorporated herein by reference.

No takeover bid has been instigated by third parties in respect of our equity during the current or previous fiscal years.

B. BUSINESS OVERVIEW

We are a commercial-stage, global, fully-integrated biopharma company developing a deep pipeline of differentiated

therapies for the treatment of severe autoimmune diseases. By combining our suite of antibody engineering technologies

with the disease biology expertise of our research collaborators, we aim to translate immunology breakthroughs into a

pipeline of novel antibody-based medicines through our discovery engine, the IIP. We developed and are

commercializing the first approved FcRn blocker in more than 30 countries and we are evaluating efgartigimod in

multiple serious autoimmune diseases. We are also advancing our second asset, empasiprubart, a C2 inhibitor, now in

Phase 3. Several earlier stage experimental medicines, including ARGX-119, a MuSK agonist, are now in its first patient

proof-of-concept studies.

For additional information regarding our Company’s principal markets and revenue breakdown, see “Item 5.A. —

Operating Results” in our Annual Report for the period ended December 31, 2024 which is incorporated herein by

reference.

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2024 In Brief

Operational Highlights

In 2024, we established our ‘Vision 2030’ outlining our long-term commitment to transform the treatment of severe

autoimmune disease with VYVGART, empasiprubart and our expanding pipeline of antibody-based therapeutics. With

our eyes set on 2030, we are targeting the treatment of 50,000 patients globally, securing 10 labeled indications across all

approved medicines, and advancing five pipeline candidates into Phase 3 development.

In 2024, we made important progress to reach this goal. We grew our global commercial footprint in gMG to reach more

than 10,000 patients and we remain on track to expand into additional regions throughout 2025. We received FDA

approval for VYVGART HYTRULO for the treatment of CIDP and have been working hard to bring VYVGART

HYTRULO to CIDP patients, reaching approximately 1,000 patients by the end of 2024. This, together with our

continued growth in MG, translated in $2.2 billion in product net sales in 2024. We look forward to continued

commercial execution as we expand our patient reach through label enabling studies in seronegative gMG and ocular

MG patient populations and we continue to innovate on the patient experience with our pre-filled syringe (PFS) with

VYVGART SC, with an PDUFA Date of April 10, 2025.

We made significant progress in evaluating efgartigimod across additional autoimmune diseases. We announced the GO-

decisions for primary Sjögren’s disease (SjD) and three subsets of myositis (immune-mediated necrotizing myopathy

(IMNM), anti-synthetase syndrome (ASyS), dermatomyositis (DM)), for which we are currently running Phase 3 clinical

trials. We continue to evaluate efgartigimod in more than 10 additional indications, and this year, we added autoimmune

encephalitis to the line-up. We are excited to add another indication in 2025.

In 2024 we made significant progress with our second asset, empasiprubart (ARGX-117) targeting complement

component 2 (C2). empasiprubart has now shown proof-of-concept in multifocal motor neuropathy (MMN) and has

started its first Phase 3 in this indication. We additionally announced CIDP as the 4th indication for which we go straight

to a Phase 3 clinical trial, expected to start in 2025.

Beyond our first two assets, efgartigimod and empasiprubart, we worked to further advance our third clinical pipeline

asset, ARGX-119, targeting muscle-specific kinase (MuSK). ARGX-119 has started its first proof-of-concept clinical

trial in congenital myasthenic syndrome (CMS) and amyotrophic lateral sclerosis (ALS) this year and we have

announced a 3rd indication, spinal muscular atrophy (SMA). We believe ARGX-119 has potential as a novel treatment

modality in multiple serious indications.

Our immunology innovation program (IIP) is a key driver for our future sustainable growth. This is reflected in 4 new

investigational new drugs (INDs) that will start Phase 1 clinical trials in 2025 to continue to deliver immunology

innovations to the patients who need them.

Reach More Patients Globally with VYVGART

•VYVGART is now approved in the U.S., Japan, the EU, the UK, Switzerland, Israel, Mainland China, Canada, South

Korea, United Arab Emirates, Australia and Kuwait (through Genpharm Services FZ-LLC (Genpharm)) for the

treatment of gMG. VYVGART is now also approved and launched in Japan for the treatment of ITP. VYVGART SC

is now approved in the U.S., the EU, the UK, Japan, China (through Zai Lab), Australia and Kuwait (through

Genpharm) for the treatment of gMG and in the U.S., Japan, and China for the treatment of CIDP. VYVGART is the

only gMG treatment available as both an intravenous (IV) and a simple SC injection, providing choice to patients in

how and where they are treated.

•In 2024, we generated product net sales of $2.2 billion

•Pricing and reimbursement discussions for VYVGART and VYVGART SC remain ongoing in multiple jurisdictions,

including in several countries in the EU, with new agreements in place in France, Luxembourg, Belgium, the

Netherlands, Poland, Slovakia and Austria.

•We filed for approval of VYVGART for gMG in Saudi Arabia and are expecting a decision on approval in 2025.

•We filed for approval of VYVGART SC for CIDP in the EU and are expecting a decision on approval in 2025.

•We received approval of the PFS for gMG in Europe on February 13, 2025.

•We filed for approval of the PFS for gMG and CIDP in the U.S. with a PDUFA Date of April 10, 2025. We also filed

for approval in Canada and Japan with expected decisions on approval in 2025.

Table of Contents

Advance Extensive Pipeline

We continue to demonstrate breadth and depth within our immunology pipeline and have advanced multiple pipeline-in-

a-product candidates. With efgartigimod, we are furthering our leadership in neonatal Fc receptor (FcRn) and we are

continuing its development in more than 10 indications today. Beyond efgartigimod, we are advancing our other clinical

pipeline programs, including empasiprubart (C2 inhibitor) which has now shown proof-of-concept in MMN and initiated

its first Phase 3 clinical trial, and is in Phase 2 POC clinical trials in delayed graft function (DGF) and DM. We also

announced CIDP as the 4th indication for empasiprubart during our R&D Day on July 16, 2024 and plan to start a

registrational study in CIDP evaluating empasiprubart head-to-head versus intravenous IgG (IVIg) in first half of 2025.

In addition, we have initiated Phase 1b/2a clinical trials of ARGX-119, a MuSK agonist, in CMS congenital myasthenic

syndromes and ALS. Four new pipeline candidates were nominated in 2024 from our immunology innovation program

(IIP), including: ARGX-213, ARGX-121 and ARGX-220 and ARGX-109. Phase 1 results expected for ARGX-109 in

second half of 2025 and for ARGX-213 and ARGX-121 in first half of 2026.

Pioneer the FcRn Pathway with efgartigimod

Neurology indications:

•CIDP (ADHERE): following the positive topline results from the ADHERE clinical trial in CIDP, a supplemental

biologics license application (sBLA) for efgartigimod SC was approved for the treatment of CIDP and launched in

July 2024 in the U.S. We also received approval in Japan and China for the treatment of CIDP.

•Myositis (ALKIVIA): In November 2024, we announced the GO decision to continue Phase 3 of the ALKIVIA

clinical trial.

◦The decision to continue clinical development of efgartigimod SC in each of the three myositis

subtypes, including IMNM, ASyS and DM, is supported by the efficacy and safety results from the Phase 2

portion of the seamless Phase 2/3 ALKIVIA clinical trial. Overall, the clinical trial met its primary endpoint,

demonstrating a statistically significant treatment effect in mean total improvement score (TIS) at week 24, and

showed improvement across all six core set measures of the TIS in favor of efgartigimod SC compared to placebo.

The observed safety and tolerability profile was consistent to that demonstrated with other clinical trials.

◦Topline results expected 2H 2026.

•TED (UplighTED): registrational clinical trials in thyroid eye disease (TED) ongoing with efgartigimod PFS. Topline

results expected 2H 2026.

•Seronegative gMG (ADAPT-SERON): registrational clinical trial in seronegative gMG patients ongoing with

efgartigimod IV. Topline results expected 2H 2025.

•Ocular MG (ADAPT-OCULUS): registrational clinical trial in ocular MG patients ongoing with efgartigimod PFS.

Topline results expected 1H 2026.

Hematology/rheumatology indications:

•ITP (ADVANCE-IV): positive clinical trial results formed the basis of approval in Japan for ITP, received on March

26, 2024.

•ITP (ADVANCE-NXT): confirmatory clinical trial in ITP ongoing with efgartigimod IV in the U.S. Topline results

expected in 2H 2026.

•Primary SjD (RHO): following the analysis of topline data from the Phase 2 POC clinical trial through our

partnership with IQVIA Ltd (IQVIA) in SjD we decided to continue the development of efgartigimod PFS to Phase 3

(UNITY), which was initiated at the end of 2024. Topline results expected in 2027.

•Systemic Sclerosis (SSc): Phase 2 POC clinical trial ongoing. Topline results expected in 2H 2026.

Nephrology indications:

•Lupus Nephritis: Phase 2 POC clinical trial ongoing through our partnership with Zai Lab. Topline results expected in

2H 2025.


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•Antibody-mediated rejection: shAMRock Phase 2 POC clinical trial in antibody-mediated rejection (AMR) has been

initiated.

In 2024 we made the decision to stop development in PC-POTS (ALPHA), Bullous Pemphigoid (BALLAD) and

membranous nephrology based on review of the Phase 2 data.

Broaden Immunology Pipeline with empasiprubart and ARGX-119

empasiprubart (C2 inhibitor):

•MMN (ARDA): based on the positive Phase 2 POC data of empasiprubart in MMN we have advanced empasiprubart

into Phase 3 (EMPASSION). Topline results expected in 2H 2026.

◦In January 2024, we reported positive clinical data from the first cohort of the Phase 2 POC ARDA

clinical trial establishing POC in MMN. empasiprubart demonstrated a 91% reduction in the need for IVIg rescue

compared to placebo [HR (95% CI) = 0.09 (0.2 : 0.44)].

◦In July 2024, we reported positive clinical data from the second cohort of the Phase 2 POC ARDA

clinical trial confirming POC in MMN. empasiprubart demonstrated a 84% reduction in the need for IVIg rescue

compared to placebo [HR: (95% CI) = 0.16 (0.02 : 1.54)].

◦Safety profile was consistent with Phase 1 data in both cohorts.

◦We are also conducting a natural history study (IMMERSION) in MMN.

•DGF (VARVARA) and DM (EMPACIFIC) Phase 2 POC clinical trials ongoing in DGF and DM. Topline results

expected 2H 2025 and 1H 2026, respectively.

•CIDP (EMVIGORATE): Phase 3 clinical trial in CIDP expected to start in 1H 2025.

ARGX-119 (MuSK agonist):

•Phase 1 dose-escalation clinical trial in healthy volunteers completed; data supports advancement in POC studies.

•CMS: Phase 1b clinical trial started to assess early signal detection in patients with CMS. Topline results expected in

2H 2025.

•ALS (reALiSe): Phase2a clinical trial started to assess early signal detection in patients with ALS. Topline results

expected 1H 2026.

Build out the Innovation Ecosystem

•In January 2024, we announced the nomination of four new pipeline candidates, including: ARGX-213 targeting

FcRn, furthering argenx’s leadership in this new class of medicine; ARGX-121 targeting Immunoglobulin A (IgA)

and ARGX-220, which are first-in-class targets broadening argenx’s focus across the immune system; and

ARGX-109, targeting IL-6, which plays an important role in inflammation. Preclinical work is ongoing in each

candidate and the first healthy volunteer studies are expected to start in 2025.

Corporate Achievements

•Dr. Brian Kotzin joined the Board of Directors in May 2024 as a non-executive director and chairperson of the

research and development committee

•Mr. Peter Verhaeghe, who has served as a non-executive director since July 2014, was reappointed as a non-executive

director and chairperson of the Board of Directors for a term of 2 years

•Dr. Pamela Klein, who has served as a non-executive director since April 2016, was reappointed as a non-executive

director for a term of 2 years

•Expansion to 1,599 full-time employees (as of December 31, 2024) to support further growth of our business,

including fully staffed commercial teams in the U.S., Europe, Japan and Canada


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•efgartigimod is an IgG1 antibody Fc fragment that has been engineered for increased affinity to FcRn compared

to endogenous IgG. efgartigimod selectively reduces IgG by blocking FcRn-mediated IgG recycling without

impacting antibody production, or affecting other parts of the immune system. It is approved in three

indications, including gMG, CIDP and ITP, and is being evaluated in more than 10 additional serious

autoimmune indications.

•empasiprubart (C2 inhibitor): empasiprubart is a novel complement inhibitor targeting C2, blocking the

function of both the classical and lectin pathways while leaving the alternative pathway intact. We believe

empasiprubart has the potential to be a pipeline-in-a-product candidate and is being evaluated in 4 serious

autoimmune diseases, of which 2 indications are in Phase 3.

•ARGX-119 (MusK agonist): ARGX-119 is an agonist SIMPLE ANTIBODY™ to the MuSK receptor with

potential in multiple neuromuscular indications. It is currently in proof-of-concept studies for CMS (Phase 1b

clinical trial), ALS (Phase 2a) and will start in SMA in 2025.

•Preclinical Candidates: Four INDs to start Phase 1 studies in 2025:

◦ARGX-213, targets FcRn, furthering argenx’s leadership in this new class of medicine

◦ARGX-121 targeting IgA and ARGX-220 both broadening argenx’s focus across the immune system

◦ARGX-109, targets IL-6, which plays an important role in inflammation

•In addition to our wholly-owned pipeline, we have candidates that emerged from our IIP that we out-licensed to

a partner for further development and for which we have milestone, royalty or profit-share agreements. These

candidates include, amongst others: cusatuzumab (anti-CD70 antibody – OncoVerity), ARGX-112 (LP-0145 –

anti-IL-22R antibody – LEO Pharma), ARGX-114 (AGMB-101 – agonistic anti-MET antibody – Agomab) and

ARGX-115 (ABBV-151 – anti-GARP antibody – AbbVie).

Immunology Innovation Program (IIP)

Our IIP is central to our core business strategy of co-creation and innovation. The IIP also serves as our discovery engine

to identify novel targets and together, in collaboration with our scientific and academic partners, to build potential new

pipeline candidates. Every current pipeline candidate from both our wholly-owned and partnered pipeline emerged from

an IIP collaboration. The IIP enables us to build our broad pipeline of products and product candidates and advance our

long-term strategy to be a sustainable, integrated immunology company.

Examples of our IIP programs include:

•efgartigimod emerged from a collaboration with Professor Sally Ward at the University of Texas Southwestern

Medical Center and later became one of the blueprints for our IIP collaborations. Professor Ward’s research

identified the crucial role that FcRn plays in maintaining and distributing IgGs throughout the body.

efgartigimod is a human IgG1 Fc fragment that is equipped with ABDEG™ mutations, which we in-licensed

from the University of Texas Southwestern Medical Center. These proprietary mutations modified efgartigimod

to increase its affinity for FcRn while retaining the pH-dependent binding that is characteristic of FcRn

interactions with its natural ligand, endogenous IgG.

•empasiprubart was built in collaboration with Broteio Pharma B.V. (Broteio). Broteio was launched in 2017

with support from Professor Erik Hack and the University of Utrecht, to conduct research demonstrating

preclinical POC of the mechanism of action of empasiprubart. Professor Hack is a renowned researcher in the

role of inflammation in disease, specifically in the complement system, and has contributed research and

expertise to the approval of two complement inhibitors. His understanding of the mild phenotype associated

with a natural C2 deficiency and C2’s unique positioning at the junction of the classical and lectin pathways led

to our interest in engineering empasiprubart with our proprietary NHANCE™ mutations and LALA mutations.

•ARGX-119 was built in collaboration with the Leiden University Medical Center (LUMC) and New York

University (NYU) with support from teams led by Professor Verschuuren and Professor Steve Burden,

respectively. Both groups have world-class expertise in unraveling the biological mechanism of neuromuscular

disease and translating these insights from the lab to the patient.

We bring to the collaboration our unique suite of antibody discovery and antibody engineering technologies and

experience in clinical development to complement our partners’ expertise in disease and target biology. Our suite of

technologies include amongst others our SIMPLE ANTIBODY™ platform technology and NHANCE™, ABDEG™,


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POTELLIGENT®, and DHS mutations that focus on engineering the Fc region of antibodies in order to augment their

intrinsic therapeutic properties. For more information, please see “Item 4.B — Business overview — Antibody

Engineering and Other Technology Capabilities”.

Our Suite of Technologies

•Through our IIP, we collaborate with scientific and academic partners to identify immunology breakthroughs and

build potential pipeline candidates. This is done through co-creation. We bring to the collaboration our unique suite of

antibody engineering technologies and experience in clinical development to complement our partners’ expertise in

disease and target biology.

•SIMPLE ANTIBODY™ platform technology: Our proprietary SIMPLE ANTIBODY™ platform technology, based

on the powerful llama immune system, allows us to exploit novel and complex disease biology targets. The platform

sources antibody variable regions (V-regions) from the immune system of outbred llamas, each of which has a

different genetic background. The llama produces highly diverse panels of antibodies with a high human homology,

or similarity, in their V-regions when immunized with targets of human disease. Our SIMPLE ANTIBODY™

platform technology allows us to access and explore a broad target universe while potentially minimizing the long

timelines associated with generating antibody candidates using traditional methods.

•NHANCE™, ABDEG™, POTELLIGENT®, and DHS mutations focus on engineering the Fc region of antibodies in

order to augment their intrinsic therapeutic properties. In addition, we obtained a non-exclusive research license and

option from Chugai Pharmaceutical Co., Ltd. (Chugai) for the SMART-Ig® (‘Recycling Antibody’ and part of

‘Sweeping Antibody’) and ACT-Ig® (Antibody half-life extending) technologies. These technologies are designed to

enable us to expand the therapeutic index of our product candidates, which is the ratio between toxic and therapeutic

dose, by potentially modifying their half-life, tissue penetration, rate of disease target clearance and potency. In 2020,

we also entered into a non-exclusive research agreement with the Clayton Foundation under which we may access the

Clayton Foundation’s proprietary DHS mutations to extend the serum half-life of therapeutic antibodies.

Our Products and Product Candidates

The following table summarizes key information on our portfolio of lead products and product candidates as of the date

of this Annual Report.

Table of Contents

Our Programs

VYVGART

Approvals and Regulatory Plan

Our two approved medicines, VYVGART and VYVGART SC, are FcRn blockers. VYVGART is approved in more

than 30 countries for the treatment of adults with gMG who are anti-acetylcholine receptor (AChR) antibody positive

(AChR-AB+) and for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal

immunosuppressive therapies (ISTs), including seronegative patients, in Japan. VYVGART is now also approved for the

treatment of adult patients with ITP in Japan. Our second product, VYVGART SC, is a subcutaneous combination of

efgartigimod alfa and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme Therapeutics, Inc.’s (Halozyme)

ENHANZE® SC drug delivery technology. It has been approved for the treatment of adults with gMG who are AChR-

AB+ as VYVGART HYTRULO in the U.S. and China, as VYVGART in the EU, and as VYVGART SC in the UK,

Israel. It has also been approved as VYVDURA in Japan for the treatment of adults with gMG who do not have

sufficient response to steroids or non-steroidal ISTs, including seronegative patients. VYVGART SC has now also been

approved for the treatment of adults with CIDP in the U.S. and China as VYVGART HYTRULO and in Japan as

VYVDURA.

More approvals and launches of both VYVGART and VYVGART SC in multiple jurisdictions and countries are

planned following pricing and reimbursement negotiations. The following table summarizes the status of regulatory

approvals and commercialization efforts for VYVGART IV, VYVGART SC and PFS as March 17, 2025:

Product

Product name

Indication

Geography

Submission

Approval

Launched

VYVGART

gMG

December 17, 2021

VYVGART

gMG

Europe

August 10, 2022

Germany was the

first European

country to launch on

September 1, 2022

VYVGART

gMG

Canada

September 19, 2023

November 6, 2023

VYVGART

gMG

Israel

April 24, 2023

Not marketed

VYVGART

gMG

Japan

January 20, 2022

May 9, 2022

VYVGART

gMG

The UK

March 14, 2023

Not marketed

VYVGART

gMG

China

June 30, 2023

September 5, 2023

VYVGART

gMG

Australia

February 24, 2025

Not available

VYVGART

gMG

Kuwait

February 19, 2025

Not available

VYVGART

gMG

Saudi Arabia

Submitted

Not available

VYVGART

gMG

Korea (the Republic

of)

January 20, 2025

Not available

VYVGART

gMG

United Arab

Emirates

October 30, 2024

Not marketed

VYVGART

gMG

Switzerland

October 3, 2024

Not marketed

VYVGART

ITP

Japan

March 26, 2024

On the market since

launch of IV

product

Not available

gMG

Brazil

Planned

submission 2H

2025

Not available

gMG

Singapore

Not available


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Product

Product name

Indication

Geography

Submission

Approval

Launched

VYVGART

HYTRULO

gMG

June 20, 2023

VYVGART

HYTRULO

CIDP

June 21, 2024

On the market since

launch of SC

product

VYVGART

gMG

Australia

February 24, 2025

Not available

VYVGART

gMG

Europe

November 15, 2023

Germany was the

first European

country to launch on

December 15, 2023

VYVGART

CIDP

Europe

Submitted

Expected in 2H 2025

Not available

gMG

Switzerland

February 10, 2025

Not available

VYVGART

gMG

The UK

February 6, 2024

Not marketed

VYVGART

gMG

Israel

September 23, 2024

Not marketed

VYVGART

HYTRULO

gMG

China

July 9, 2024

December 3, 2024

VYVGART

HYTRULO

CIDP

China

November 5, 2024

On the market since

launch of SC

product

VYVDURA

gMG

Japan

January 18, 2024

April 17, 2024

VYVDURA

CIDP

Japan

December 27, 2024

On the market since

launch of SC

product

PFS

VYVDURA

gMG

Japan

Submitted

Expected in 2H 2025

Not available

VYVDURA

CIDP

Japan

Submitted

Expected in 2H 2025

Not available

gMG

U.S.

Submitted

Expected in 1H 2025

Not available

CIDP

U.S.

Submitted

Expected in 1H 2025

Not available

VYVGART

gMG

Europe

February 13, 2025

VYVGART

CIDP

Europe

Submitted

Expected in 1H 2025

Not available

gMG

Canada

Submitted

Expected in 2H 2025

Not available

CIDP

Canada

Submitted

Expected in 2H 2025

Not available

gMG

The UK

Submitted

Not available

Commercialization

We have established our own sales force in the U.S., Japan, Europe and Canada for VYVGART for the treatment of

gMG and CIDP (where approved). We plan to expand our own sales and marketing capabilities and promote our

products and product candidates in other regions if we decide there is a business case to do so after regulatory approval

has been obtained.

Development and commercialization may also be done through collaborations with third parties. In January 2021, we

entered into an exclusive out-license agreement with Zai Lab (Zai Lab Agreement), a commercial-stage

biopharmaceutical company, for the development and commercialization of efgartigimod in Greater China, (which

includes Mainland China, Hong Kong, Taiwan and Macau, Greater China). Zai Lab announced approval of VYVGART

in Mainland China in June 2023 for the treatment of adult gMG patients and in 2024 Zai Lab also announced the

approval of VYVGART SC for gMG and CIDP. Under the Zai Lab Agreement, we received and continue to be eligible

for certain sales-based milestone payments and royalties based on annual product net sales of efgartigimod in Greater

China.

In October 2021, we announced an exclusive distribution agreement with Medison to commercialize efgartigimod for

gMG in Israel (Medison Agreement). Medison filed for and obtained approval for VYVGART in April 2023 and for

VYVGART SC in September 2024. On June 6, 2022 we announced an exclusive multi-regional agreement with

Medison to commercialize efgartigimod in 14 countries, including Poland, Hungary, Slovenia, Czech Republic,


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Romania, Bulgaria, Lithuania, Croatia, Slovakia, Estonia, Latvia, Greece, and Cyprus, for the treatment of adult patients

with gMG (Medison Multi-Regional Agreement).

In January 2022, we entered into a partnership agreement with Genpharm, under which Genpharm shall purchase

VYVGART from us for the resale in the Gulf Cooperation Council (comprising Saudi Arabia, Kuwait, the United Arab

Emirates, Qatar, Bahrain and Oman) on an exclusive basis for Genpharm’s own account and own name (Genpharm

Agreement).

In 2023, we entered into the Handok Agreement for the distribution of VYVGART in South Korea and in 2024 we

received approval for VYVGART in South Korea.

We intend to sign additional distribution partnerships for other territories.

In the U.S., argenx advertises certain products via digital and traditional media channels, including the internet and

television.

For a discussion of total revenues by geographic market, please see “Note 17 — Segment Reporting” in our consolidated

financial statements which are appended to our Annual Report for the period ended December 31, 2024, and which are

incorporated herein by reference.

Pre-Approval Access Program

We are committed to improving the lives of people suffering from rare diseases. We are driven to discover new

treatment approaches fueled by the resilience of patients to urgently deliver them. We aim to do this in partnership; we

listen to patients, supporters and advocacy communities, and we hear their stories. Their insights guide us as we develop

our investigational therapies and motivate us to advance the understanding of rare diseases.

We have a Pre-Approval Access program (PAA) for patients with gMG which opened on February 21, 2021 for patients

who are unable to participate in an ongoing clinical trial. In 2024, we approved access to this PAA for over 403 gMG

patients in 14 countries. The PAA program remains open in countries where VYVGART is not yet launched or

reimbursed.

efgartigimod (formerly ARGX-113) Development

Mechanism of Action

As shown in Figure 1, efgartigimod is a human IgG1 Fc fragment equipped with our ABDEG™ mutations that is

designed to target the FcRn and reduce IgG. FcRn is foundational to the immune system and functions to recycle IgG,

extending its serum half-life over other IgGs that are not recycled by FcRn. IgGs that bind to FcRn are rescued from

lysosomal degradation. By binding to FcRn, efgartigimod can reduce IgG recycling and increase IgG degradation.

Compared to alternative immunosuppressive approaches, such as B-lymphocyte (B-cell) depleting agents, efgartigimod

acts in a highly selective manner. For efgartigimod, we now have an estimated 8,000 patients years of safety follow-up

between clinical trials and real world experience. efgartigimod has been observed to significantly reduce concentrations

of all IgG subtypes without decreasing levels of other IgGs or human serum albumin, which is also recycled by FcRn,

discussed in more detail in “Item 4.B. — Business Overview — Formulations” below.


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Figure 1: efgartigimod’s mechanism of action blocks the recycling of IgG antibodies and removes them from circulation

Based on its mechanism of action in targeting FcRn to selectively reducing IgGs, efgartigimod has the potential to

address a multitude of severe autoimmune diseases where pathogenic IgGs are believed to be mediators of disease.

As of the end of 2024, we are evaluating efgartigimod in more than 10 serious autoimmune indications and plan to

continue to expand into new indications.

Indication Selection Strategy

We utilize the following strategy to select indications for efgartigimod:

•We first start with a strong, unifying biological rationale. The indications in our pipeline are unified in that there

exists a wide range of supportive evidence that demonstrates that each is IgG-mediated. This ranges from published

literature, clinical trials with currently used therapies such as IVIg, PLEX, or rituximab, and other experiments, such

as passive transfer models.

•We also look at indications where a significant clinical or commercial opportunity exists. These are disease areas

where there is a significant unmet need for innovation as patients are often not well-managed by current therapies and

their respective side effects.

•Furthermore, for each indication, there is a defined path forward with established precedent for how to run POC and

registrational clinical trials with generally accepted clinical and regulatory endpoints.

Formulations

Overview

We are developing two formulations of efgartigimod to address the needs of patients, physicians, and payers across

indications and geographies, including efgartigimod IV (VYVGART) and efgartigimod SC (VYVGART SC).

Scientific Publications

We refer to our key scientific publications from our Phase 3 studies with either the IV or SC formulation in gMG, ITP

and CIDP.

•Publication in The Lancet Neurology of Phase 3 ADAPT study data in generalized myasthenia gravis: https://

www.thelancet.com/journals/laneur/article/PIIS1474-4422(21)00159-9/abstract

•Publication in The Lancet of Phase 3 ADVANCE-IV study data in primary immune thrombocytopenia: https://

www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01460-5/abstract

•Publication in The Lancet Neurology of Phase 3 ADHERE study data in chronic inflammatory demyelinating

polyneuropathy: https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(24)00309-0/abstract


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efgartigimod Indications

Clinical trial overview


Clinical Trial	Stage	Indication	Patients	Primary Endpoint	Status
ADAPT	Registrational	gMG		The proportion of responders based on the Myasthenia Gravis Activities of Daily Living (MG-ADL) score	Marketed
ADAPT-SC	Registrational	gMG		The proportion of responders based on the Myasthenia Gravis Activities of Daily Living (MG-ADL) score	Marketed
ADAPT- SERON	Registrational	seronegative gMG	110	MG-ADL total score change from baseline to day 29 (w4)	Ongoing clinical trial results expected 2H 2025
ADAPT- OCULUS	Registrational	ocular MG	92-124	Change in MGII PRO ocular score from baseline to day 29 (w4)	Ongoing clinical trial results expected 1H 2026
ADHERE	Registrational	CIDP	322	The hazard ratio for the time to first adjusted INCAT deterioration	Marketed
ADVANCE- IV	Registrational	ITP		The proportion of patients that achieved sustained platelet response	Marketed
ADVANCE- NXT	Registrational	ITP	63	Extent of disease control (cumulative number of weeks over the planned 24-week treatment period with platelet counts of ≥ 50×109/L	Ongoing clinical trial results expected in 2H 2026
BALLAD	Registrational	BP	98	The proportion of participants in complete remission while off oral corticosteroids for at least eight weeks at week 36	Clinical trial discontinued in 2024
ALKIVIA	Registrational	Myositis	Target 240	The total improvement score (TIS) at the end of treatment period	Ongoing clinical trial results expected in 2H 2026
RHO	PoC	Primary SjD	Target 30	The proportion of responders to the Composite of Relevant endpoints for SjD (CRESS; response on ≥ three out of five items) at week 24	GO decision made in 2024 advanced in Phase 3
UNITY	Registrational	Primary SjD	Target 580	The change from baseline on the ClinESSDAI score (w48)	Ongoing clinical trial results expected in 2027
ALPHA	PoC	POTS post- COVID19	53	The co-primary endpoints are 1) COMPASS-31 and 2) the Malmö POTS Symptom score at the end of the 24-week treatment period	Clinical trial discontinued in 2024
In partnership with Zai Lab	PoC	LN	Target 60	The change in urine protein creatinine ratio from baseline to end of the treatment period	Ongoing clinical trial results expected in 2H 2025
In partnership with Zai Lab	PoC	MN	Target 70	The change in urine protein creatinine ratio from baseline to end of the treatment period in the anti-PLA2R Ab seropositive population	Clinical trial discontinued in 2024
uplighTED	Registrational	TED	Target 108/ trial	Percentage of participants who were proptosis responders at week 24	Ongoing clinical trial results expected in 2H 2026


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Clinical Trial	Stage	Indication	Patients	Primary Endpoint	Status
shAMRock	PoC	AMR	Target 30	Safety and tolerability. Efficacy measures such as estimated glomerular filtration rate, histology and urine protein creatinine ratio are captured in the secondary endpoints	Clinical trial has been initiated in 2024
ADAPT- JUNIOR IV	Phase 2/3	gMG	Target over 12	To confirm an age-adjusted optimum dose of efgartigimod IV and provide (model- predicted) evidence for a treatment response	Ongoing clinical trial
ADAPT- JUNIOR SC	Phase 2/3	gMG	Target over 12	To confirm an appropriate dose of efgartigimod PH20 SC in pediatric participants with gMG	Ongoing clinical trial
Other clinical trials	PoC	AAV			Clinical trial discontinued in 2024
Other clinical trials	PoC	SSc	To be con firmed	To be confirmed	Ongoing clinical trial results expected in 2H 2026

gMG

Overview

gMG is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and

muscles, causing debilitating and potentially life-threatening muscle weakness.

In myasthenia gravis (MG), IgG autoantibodies either bind and occupy or cross-link and internalize the receptor on the

muscle cells, thereby preventing the binding of acetylcholine, the signal sent by the nerve cell. In addition, these

autoantibodies can cause destruction of the neuromuscular junction by recruiting complement, a potent cell-destroying

mechanism of the human immune system. The muscle weakness associated with MG usually presents initially in ocular

muscles and can then spread into a generalized form affecting multiple muscles, known as gMG. Approximately 85% of

people with MG progress to gMG within 24 months (source: Behin et al. New Pathways and Therapeutics Targets in

Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018. 265-277). MG in the ocular form initially causes droopy

eyelids and blurred or double vision due to partial paralysis of eye movements. As MG becomes generalized it affects

muscles in the neck and jaw, causing problems in speaking, chewing and swallowing. MG can also cause weakness in

skeletal muscles leading to problems in limb function. In the most severe cases, respiratory function can be weakened to

the point where it becomes life-threatening. These respiratory crises occur at least once in the lives of approximately

15% to 20% of MG patients. The U.S. prevalence of MG is estimated at approximately 20 cases per 100,000 (source:

Philips et al, Ann NY Acad Sci. 2003).

Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population (Behin et al. New

Pathways and Therapeutics Targets in Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018. 265-277).

In May 2020, we announced positive topline results from the pivotal ADAPT clinical trial of efgartigimod for the

treatment of gMG. The topline results from the ADAPT clinical trial showed that efgartigimod was well-tolerated,

demonstrated clinically meaningful improvements in strength and quality of life measures, and provided the option of an

individualized dosing schedule for gMG patients. The full Phase 3 ADAPT results were published in The Lancet

Neurology in July 2021. The data from the ADAPT clinical trial and the subsequent OLE (ADAPT+) formed the basis

for the regulatory approvals of VYVGART in the U.S., Japan, the EU, Mainland China, Israel, the UK and Canada.

On March 22, 2022, we announced positive topline results from the Phase 3 ADAPT-SC clinical trial, a registrational

non-inferiority bridging clinical trial of efgartigimod SC for the treatment of gMG. efgartigimod SC achieved the

primary endpoint of total IgG reduction from baseline at day 29, demonstrating statistical noninferiority to VYVGART

IV formulation in gMG patients. Based on these results, we received regulatory approval in the U.S., the EU, China,

Japan, Switzerland, the UK, Israel and Australia.

Table of Contents

Other clinical trials

In 2024, we initiated registrational clinical trials to expand the VYVGART label into broader MG populations, including

in seronegative gMG patients (ADAPT-SERON) and ocular MG patients (ADAPT-OCULUS). We also have clinical

trials ongoing in pediatric gMG patients (ADAPT-JUNIOR) with efgartigimod IV and efgartigimod SC.

CIDP

Overview

CIDP is a chronic autoimmune disorder of peripheral nerves and nerve roots caused by an autoimmune-mediated

destruction of the myelin sheath, or myelin producing cells, insulating the axon of the nerves and enabling speed of

signal transduction. The cause of CIDP is unknown, but abnormalities in both cellular and humoral immunity have been

shown. CIDP is a chronic and progressive disease: onset and progression occur over at least eight weeks in contrast with

the more acute Guillain-Barré-syndrome. Demyelination and axonal damage in CIDP lead to loss of sensory and/or

motor neuron function, which can lead to weakness, sensory loss, imbalance and/or pain. U.S. prevalence for CIDP

patients is 42,000 of whom 24,000 are treated patients.

Most CIDP patients require treatment, the majority currently with IVIg. Glucocorticoids and plasma exchange are used

to a lesser extent as they are either limited by side effects upon chronic use, in the case of glucocorticoids, or

invasiveness of the procedure and access, which is restricted to specialized centers in case of plasma exchange.

Alternative immunosuppressant agents are typically reserved for patients ineligible for or refractory to IVIg,

glucocorticoids or plasma exchange.

In July 2023, we announced positive topline results from the ADHERE clinical trial evaluating VYVGART SC

(efgartigimod alfa and hyaluronidase-qvfc) in adults with CIDP. The clinical trial met its primary endpoint

(p=0.000039), demonstrating a significantly lower risk of relapse with VYVGART SC compared to placebo (HR: 0.39

95% CI: 0.25; 0.61). 67% of patients in open-label Stage A demonstrated evidence of clinical improvement, indicating

that IgG autoantibodies play a significant role in the underlying biology of CIDP.

VYVGART SC was well-tolerated with a safety profile that is consistent with prior clinical trials and the known profile

of VYVGART. The most frequent treatment-related adverse event was ISRs, which occurred in a lower percentage of

patients than previous VYVGART SC clinical trials (20% in Stage A; 10% in Stage B). All ISRs were mild to moderate

and resolved over time. 99% (226/249) of eligible patients continued to the ADHERE-Plus OLE clinical trial.

Based on these results, we received regulatory approval in the U.S. in June 2024, in China in November 2024 and in

Japan in December 2024. Regulatory review is currently ongoing in other jurisdictions including in the EU.

Primary ITP

Overview

Primary ITP is an acquired autoimmune bleeding disorder, characterized by a low platelet count (<100×109/L) in the

absence of other causes associated with thrombocytopenia. In most patients, IgG autoantibodies directed against platelet

receptors can be detected. They accelerate platelet clearance and destruction, inhibit platelet production, and impair

platelet function, resulting in increased risk of bleeding and impaired quality of life. Primary ITP is differentiated from

secondary ITP, which is associated with other illnesses, such as infections or autoimmune diseases, or which occurs after

transfusion or taking other drugs, such as cancer drugs. Platelet deficiency, or thrombocytopenia, can cause bleeding in

tissues, bruising and slow blood clotting after injury. Patients may suffer from depression and fatigue as well as side

effects of existing therapies, impairing their quality of life. Current therapeutic approaches include non-specific

immunosuppression (e.g., steroids and rituximab), inhibition of platelet clearance (e.g., splenectomy, IVIg, anti-D

globulin, and spleen tyrosine kinase inhibitor fostamatinib13) or stimulation of platelet production (e.g., thrombopoietin

receptor agonist TPO-RA). Splenectomy remains the only treatment that provides sustained remission off therapy for

one year or longer for a high proportion of patients. ITP affects approximately 72,000 patients in the U.S. (sources:

Current Medical Research and Opinion, 25:12, 2961-2969; Am J Hematol. 2012 Sep; 87(9): 848–852; Pediatr Blood

Cancer. 2012 Feb; 58(2): 216–220).

Phase 3 ADVANCE Clinical Trials

In 2019, the first of two registrational clinical trials, the ADVANCE clinical trial, was initiated to evaluate efgartigimod

IV (VYVGART) for the treatment of primary ITP. The second registrational ADVANCE-SC clinical trial of

efgartigimod SC for the treatment of primary ITP was initiated in 2020.


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In May 2022, we announced positive Phase 3 data from the ADVANCE clinical trial. Primary endpoint was met,

demonstrating that a significantly higher proportion of patients with chronic ITP receiving VYVGART (17/78; 21.8%)

compared to placebo (2/40; 5%) achieved a sustained platelet response (p=0.0316), defined as having platelet counts

greater than or equal to 50x109/L on at least four of the last six scheduled visits between weeks 19 and 24 of treatment.

There was also a statistically significant separation from placebo in key platelet-derived secondary endpoints. Additional

secondary endpoint data from the ADVANCE clinical trial are consistent with primary and secondary platelet-derived

endpoints and provide additional context on metrics that often drive treatment decisions, including on International

Working Group responder status.

VYVGART was well-tolerated in this 24-week clinical trial and the observed safety and tolerability profile was

consistent with previous clinical trials. Results from ADVANCE-IV clinical trial were published in The Lancet in

September 2023.

In November 2023, results of the second registrational clinical trial as part of the ongoing ITP development program for

VYVGART in adult patients with chronic and persistent ITP were announced. Patients were heavily pre-treated and 75%

of patients had received three or more prior ITP therapies. The clinical trial did not meet the primary endpoint of a

sustained platelet count response in chronic ITP patients. Secondary endpoints were also not met, including additional

endpoints on International Working Group responder status and mean platelet count change from baseline.

VYVGART SC was well-tolerated in ADVANCE-SC; the observed safety and tolerability profile was consistent with

ADVANCE-IV and the confirmed safety profile of VYVGART and VYVGART SC.

Based on the results of the ADVANCE-IV clinical trial we received regulatory approval for VYVGART for the

treatment of adults with ITP in Japan in March 2024. We have initiated ADVANCE-NEXT in the U.S. with

efgartigimod IV in ITP in 2024.

Myositis

Overview

Myositis are a rare group of autoimmune diseases that can be muscle specific or affect multiple organs including the

skin, joints, lung, gastrointestinal tract and heart. Myositis can be very severe and disabling and have a material impact

on quality of life. Initially these Myositis were classified as either DM or polymyositis, but as the underlying

pathophysiology of Myositis has become better understood, including through the identification of characteristic

autoantibodies, new polymyositis subgroups have emerged. Two of these subtypes are IMNM and ASyS. Proximal

muscle weakness is a unifying feature of each Myositis subset.

•IMNM is characterized by skeletal muscle weakness due to muscle cell necrosis. The muscle weakness is typically

symmetrical – on both sides of the body – and affects proximal muscles including hips, thighs, upper arms, shoulder

and neck. The muscle weakness can be severe and lead to difficulty in completing daily tasks. Characteristic

autoantibodies of IMNM, include anti-signal recognition particle and anti-3-hydroxy-3-methylglutaryl-coenzyme A

reductase autoantibodies.

•ASyS is characterized by muscle inflammation, inflammatory arthritis, interstitial lung disease, thickening and

cracking of the hands (mechanic’s hands) and Raynaud phenomenon. Autoantibodies associated with ASyS attack

tRNA synthetase enzymes and include anti-Jo-1 and anti-PL1 and PL-12 most commonly.

•DM is characterized by muscle inflammation and degeneration and skin abnormalities, including heliotrope rash,

Gottron papules, erythematous, calcinosis and edema. DM is associated with Myositis-specific autoantibodies,

including anti-Mi-2, anti-MDA-5, anti-TIF-1γ and others.

There are no current FDA-approved therapies for IMNM or ASyS. IVIg (Octagam 10%) was approved by the FDA for

the treatment of DM in July 2021. Myositis patients are most often treated with high-dose steroids.

ALKIVIA Clinical Trial

We initiated the registrational ALKIVIA clinical trial of efgartigimod SC for the treatment of Myositis in 2022. The

clinical trial will enroll approximately 240 patients in three Myositis subtypes, IMNM, ASyS and DM. The clinical trial

is being conducted in two Phases, with an analysis of the Phase 2 portion of the clinical trial, including 30 patients of

each subtype, followed by conduct of the Phase 3 portion of the clinical trial only if a signal is observed in the Phase 2

portion of the clinical trial.


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The primary endpoint is the total improvement score (TIS) at the end of the treatment period. Key secondary endpoints

include response rates at the end of treatment, time to response, and duration of response in TIS, as well as change from

baseline in individual TIS components. Other secondary endpoints include quality of life and other functional scores.

In November 2024, argenx announced our 'GO' decision to continue clinical development of efgartigimod SC in the

seamless phase2/3 ALKIVIA clinical trial (ongoing) in all three Myositis subtypes following analysis of topline data

from the Phase 2 portion of the clinical trial. The decision is supported by the efficacy and safety results from the Phase

2 portion of the seamless Phase 2/3 ALKIVIA clinical trial. Overall, the clinical trial met its primary endpoint,

demonstrating a statistically significant treatment effect in mean TIS at Week 24, and showed improvement across all six

core set measures of the TIS in favor of efgartigimod SC compared to placebo. The observed safety and tolerability

profile was consistent to that demonstrated with other clinical trials.

TED

Overview

TED is an autoimmune orbital disease associated with Graves’ disease and other autoimmune thyroid pathologies such

as Hashimoto’s thyroiditis. TED is characterized by extraocular muscle enlargement, orbital adipose tissue expansion,

and orbital inflammation, which can lead to proptosis, diplopia, or vision loss in severe cases. Persistent orbital

symptoms often impair patient QoL long-term.

Substantial nonclinical and clinical evidence supports thyrotropin receptor autoantibodies as causative in the pathology

of TED. Clinical evidence supports the removal of autoantibodies as a mechanism for the treatment of TED. By reducing

IgGs, including TED-associated pathogenic IgG autoantibodies, efgartigimod is expected to ease disease manifestations.

Additionally, IgG reduction could address the underlying hyperthyroidism. Side effects and tolerability issues with

current therapies, including steroids and teprotumumab (only FDA-approved biologic), are treatment limiting for many

patients based on comorbidities and a significant unmet need remains for safe and convenient therapies.

UplighTED Clinical Trials

The UplighTED program aims to evaluate the efficacy and safety of weekly efgartigimod for SC administration in pre-

filled syringe, coformulated with rHuPH20 (efgartigimod PH20 SC) in two randomized, placebo-controlled, double-

blinded studies. Adult participants with moderate-to-severe active TED, with controlled baseline autoimmune thyroid

pathology are dosed with 1000mg efgartigimod PH20 SC or placebo PH20 SC for 24 weeks and evaluated for proptosis

response. At the end of the treatment period, participants will enter a follow-up observational period to assess safety,

tolerability, and durability of efgartigimod PH20 SC treatment while off therapy or an open-label treatment period

depending on their response to study treatment.

SjD

Overview

SjD is a chronic, progressive autoimmune disease, characterized by lymphocytic infiltration and progressive destruction

of exocrine glands. B-cells play a pivotal role in the development of the disease and this results amongst others in

production of IgG autoantibodies, especially those which target SSA/Ro, SSB/La ribonuclear complexes. In addition to

symptoms of dry eyes, dry mouth, chronic pain and fatigue, a substantial subset of patients suffer from extraglandular

systemic disease. There are no FDA-approved treatments currently registered for the treatment of SjD.

Phase 2 RHO Clinical Trial (in partnership with IQVIA)

In March 2024, argenx announced its plan to continue the development of efgartigimod to Phase 3 in adults with primary

SjD, following the analysis of topline data from the Phase 2 RHO clinical trial.

•The decision to advance the clinical development of efgartigimod in SjD was supported by the safety, efficacy and

biomarker results from the clinical trial. The observed safety and tolerability profile was consistent with other clinical

trials. Efficacy assessments showed a treatment effect across multiple clinical endpoints, which were also consistent

with biomarker data.

◦In the RHO clinical trial, efgartigimod demonstrated increased response on composite endpoints

(CRESS, STAR, ESSDAI (22-34%)). A response was observed in four out of five items of CRESS.


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◦The IgG reduction and biomarker data correlated to clinical benefit and efgartigimod was well

tolerated and safe similar to other clinical trials.

Phase 3 UNITY Clinical Trial (in partnership with IQVIA)

In 2024, we initiated a Phase 3 clinical trial evaluating efgartigimod PH20 SC for the treatment of SjD. The Unity

clinical trial is a randomized, placebo-controlled, double-blind clinical trial evaluating safety and efficacy of

efgartigimod PH20 SC. The clinical trial plans to enroll 480 patients with at least moderate systemic disease

(ClinESSDAI ≥6). Patients have to be on stable background treatment and positive for anti-SSA/Ro. At the end of the

48-week treatment period, participants who complete the clinical trial may roll over into an OLE. The primary endpoint

is change from baseline in the clinESSDAI (Clinical ESSDAI). Key secondary endpoints will focus on patient-reported

outcomes, ESSDAI (EULAR Sjögrens Syndrome Disease Activity Index), and STAR (Sjögren's Tool for Assessing

Response, composite endpoint).

Overview

LN is an inflammatory autoimmune disease of the kidney and one of the most severe and common organ manifestations

of the autoimmune disease systemic lupus erythematosus (SLE). In patients with SLE, approximately 25% to 50% have

signs or symptoms of kidney disease at SLE onset. Approximately 40% to 60% of patients with SLE will develop renal

involvement during the course of disease, with substantial morbidity or mortality. Pathogenic autoantibodies and

complement deposits are critically involved in SLE pathogenesis and particularly LN, where renal deposition of immune

complexes is a hallmark of the disease. Autoantibodies associated with LN include anti-dsDNA, anti-C1q, anti-

cardiolipin, anti-Smith and anti-nuclear antibodies. 10-30% of LN patients progress to end-stage renal disease. Oral

corticosteroids and broad immunosuppressants are current standards of care but are not uniformly effective. Belimumab

(Benlysta) and voclosporin (Lupkynis) are approved by the FDA for the treatment of LN.

Phase 2 POC Clinical Trial (in partnership with Zai Lab)

In 2023, we initiated a POC clinical trial to evaluate the efficacy and safety of efgartigimod IV in Chinese patients with

active LN. The clinical trial plans to enroll approximately 60 patients with LN class III or IV (with or without class V).

The primary endpoint is the change in urine protein creatinine ratio from baseline to end of the treatment period. Key

secondary endpoints include proportion of patients achieving complete and partial renal response at the end of treatment

period and time to complete renal response and partial renal response. Other secondary endpoints include additional

efficacy measurements, PK, PD, immunogenicity, biomarkers, safety, and quality of life assessments.

Other efgartigimod Indications

AMR

AMR is an autoimmune disease that affects transplanted organs and can contribute to allograft loss. AMR in kidney

allografts is driven by donor specific antibodies, which often target HLA antigens expressed by endothelial allograft

cells. Through different mechanism, donor specific antibodies can induce microvascular inflammation, a

histopathological hallmark of AMR. Microvascular inflammation leads to loss in organ function which, if continued, can

result in allograft loss. The unmet need for an efficacious treatment is very high, as evidenced by AMR being the leading

cause of kidney transplant failure. There are currently no approved therapies for treating AMR.

Phase 2 shAMRock Clinical Trial Design

In the end of 2024, we initiated a Phase 2 POC study to evaluate efgartigimod PFS in kidney transplant recipients with

AMR. The clinical trial will enroll ~30 participants, randomized 1x1x1 across 2 treatment arms and placebo. Primary

endpoint is safety and tolerability and secondary endpoints include efficacy endpoints around estimated glomerular

filtration rate, kidney biopsy, urine protein creatinine ratio and survival.

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Partnerships for efgartigimod indications

Zai Lab Limited

Pursuant to the Zai Lab Agreement, Zai Lab obtained the exclusive right to develop and commercialize efgartigimod in

Greater China. Zai Lab will also contribute patients to our global Phase 3 clinical trials of efgartigimod. Our Zai Lab

strategic collaboration allows us to accelerate development of efgartigimod into new autoimmune indications with Zai

Lab taking operational leadership of selected Phase 2 POC clinical trials.

In 2022 Zai Lab initiated the Phase 2 POC clinical trials in MN and LN, which both fall within the emerging nephrology

indications. Zai Lab also completed a Phase 1 PK/PD clinical trial to support the approval of efgartigimod for gMG in

Mainland China and to obtain regulatory approvals to enroll Chinese patient into our global Phase 3 clinical trials.

IQVIA

On December 2, 2021 we entered into a strategic asset development agreement (Asset Development Agreement) with

IQVIA. Pursuant to the Asset Development Agreement, IQVIA shall perform asset and indication development services

for efgartigimod through an advanced outsourcing model. Such services include, but are not limited to, overall product

indication development strategy, design of clinical trial protocol, set-up, execution and management of clinical

development plans for an indication for efgartigimod selected by us.

To enable and encourage fast and innovative delivery of the services by IQVIA, the Asset Development Agreement

contains an innovative earn-back and bonus plan based upon the performance of IQVIA.

Clinical trials that have been discontinued:

•In May 2024, the decision was made to discontinue planned development of efgartigimod in AAV following the risk

assessment of all ongoing clinical trials based on learnings from ADDRESS (PV) and ADVANCE SC (ITP) clinical

trials. We determined the risk did not outweigh the benefit in AAV given the potentially unmanageable interference

of background medications.

•In June 2024, we announced results from the Phase 2 ALPHA clinical trial of efgartigimod in PC-POTS. Based on

the results, we decided not to move forward development of efgartigimod in PC-POTS.

•In October 2024, we announced the discontinuation of development of efgartigimod in MN. This decision was based

on the observation that no clear signal was seen in the blinded data, which was part of an interim review by the

executive data review team and the data and safety monitoring board.

•Early January 2025, we announced our decision to discontinue development in BP based on results from 98 patients

in the Phase 2 BALLAD clinical trial.

empasiprubart (ARGX-117) Development

Mechanism of Action

empasiprubart is a differentiated therapeutic mAb targeting C2 equipped with our proprietary NHANCE™ mutations.

By addressing a novel target at the intersection of the complement and lectin pathways of the complement cascade, we

believe empasiprubart represents a broad pipeline opportunity across several severe autoimmune indications. Activation

of the classical and lectin pathway of complement may contribute to tissue damage and organ dysfunction in a number of

autoimmune inflammatory diseases and ischemia-reperfusion conditions. Targeting C2 also leaves the alternative

pathway of the complement system intact, which is an important component of the innate defense system.

empasiprubart exhibits both pH- and calcium dependent binding. These unique characteristics enable empasiprubart to

capture free C2 in circulation and release it in the endosome to be sorted for degradation in the lysosome. empasiprubart

is equipped with NHANCE™ mutations increasing its affinity for FcRn and allowing it to recycle back into circulation

to capture more C2.

In addition to an IV formulation, we have exclusive access to Halozyme’s ENHANZE® SC drug delivery technology for

the C2 target.


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Figure 3: LEFT: empasiprubart exhibits both pH- and calcium dependent target binding. RIGHT: empasiprubart is

equipped with NHANCE™ mutations increasing its affinity for FcRn at acidic pH and allowing it to recycle back into

circulation.

empasiprubart Indications

MMN

Overview

MMN is a debilitating neuromuscular autoimmune disorder that is characterized by slowly progressive muscle weakness

due to motor neuron degeneration. It mainly affects hands and forearms, mainly in males, and the median age of

diagnosis is around 40 years. Diagnosis takes about a year and a half and is often misdiagnosed as ALS. There are

estimated to be around 13,000 patients with MMN in the U.S. and this number is increasing.

Specific pathophysiologic characteristics of MMN include the presence of IgM autoantibodies against the ganglioside

GM1 and conduction block, i.e., impaired propagation of action potentials along the axon. GM1 is widely expressed in

the nervous system by neurons, particularly around the nodes of Ranvier, and Schwann cells.

IVIg is the only approved treatment for MMN and needs to be dosed frequently to address the disease’s progressive

nature.

Phase 2 POC ARDA Clinical Trial

The Phase 2 POC ARDA clinical trial was a randomized, double-blinded, placebo-controlled multicenter clinical trial to

evaluate the safety and tolerability, efficacy, PK, PD, and immunogenicity of two dose regimens of empasiprubart in

adults with MMN. The primary endpoint was safety and tolerability. Additional endpoints included time to IVIg

retreatment, biomarker analyses of C2 levels, and changes in measurements on key functional scores (modified medical

research council -10 sum score, grip strength, MMN-RODS as well as several patient-reported quality of life outcome

measures (fatigue severity score (FSS), chronic acquired polyneuropathy patient-reported index (CAP-PRI), and values

of the patient global impression change scale).

At the start of the year argenx announced positive data from the first cohort (n=16) of the Phase 2 POC ARDA clinical

trial which was confirmed with the results of the second cohort (n=16) in July 2024, establishing POC in MMN.

empasiprubart demonstrated a 91% reduction in the need for IVIg rescue compared to placebo [HR (95% CI) = 0.09

(0.02; 0.44)] in cohort 1 and a 84% reduction in the need for IVIg rescue compared to placebo [HR (95% CI) = 0.16

(0.02; 1.54)] in cohort 2.


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Based on these results argenx initiated the EMPASSION Phase 3 clinical trial evaluating empasiprubart in MMN at the

end of 2024.

Phase 3 EMPASSION Clinical Trial Design

A Phase 3, randomized, double-blinded, double-dummy clinical trial evaluating the efficacy and safety

of empasiprubart versus intravenous immunoglobulin in adults with multifocal motor neuropathy. The clinical trial

comprises a screening period of up to 15 weeks, including a minimum of 2 IVIg cycles; a 24-week (6-month),

randomized, double-blinded, double-dummy treatment period (part A) evaluating the efficacy and safety of

empasiprubart vs IVIg continuation; a 24-month OLE period (part B); and a 15-month safety follow-up period starting

after the last dose of IMP. The primary objective is to demonstrate the efficacy of empasiprubart compared to IVIg in

improving functional ability. This will be measured by change from baseline in the 25-item MMN-RODS centile score at

week 24. Additional key secondary endpoints include changes in measurements on key functional scores (modified

medical research council -14 sum score, grip strength) as well as patient-reported quality of life outcome measures

(polyneuropathy patient-reported index, and values of the patient global impression change scale and evaluation of

manual dexterity using 9HPT.

DGF

Overview

DGF, a complication after kidney transplantation, is defined as the need for dialysis in the first week after transplant.

DGF occurs in up to 40% of patients receiving a deceased donor graft, and is associated with worse long-term transplant

outcomes. DGF is often the clinical representation of ischemia reperfusion injury, in which the classical and lectin

complement pathways play an important role, as shown by compelling evidence from both (in-house) in vitro and in

vivo preclinical, and clinical trials. There are currently no approved therapies to reduce DGF risk. Furthermore, there is a

well-established process to measure kidney function and DGF, and to establish POC and achieve registration. On this

basis, combined with the significant unmet medical need, we have chosen DGF after kidney transplantation as second

indication for empasiprubart.

Phase 2 POC VARVARA Clinical Trial

The Phase 2 POC VARVARA clinical trial was initiated in 2023 and is a randomized, placebo-controlled, double-

blinded clinical trial to evaluate the efficacy, safety and tolerability of empasiprubart in improving allograft function in

recipients at risk for DGF. The clinical trial will include approximately 102 recipients of an at-risk deceased donor

kidney. After a short screening period of < 24 hours, patients are randomly assigned in a 1:1 ratio to receive two doses of

empasiprubart IV or placebo, of which one dose is administered during transplantation and one a week later. Participants

receive standardized background induction and maintenance immunosuppression. They are evaluated for 52 weeks, with

one additional safety follow-up visit in week 64. The primary endpoint is the estimated glomerular filtration rate at six

months. Key secondary endpoints include DGF risk, safety, and PK, PD and immunogenicity.

Overview

Please refer to “Item 4.B — efgartigimod Indications” (Myositis) for more information on DM.

Phase 2 POC EMPACIFIC Clinical Trial

The EMPACIFIC clinical trial is a Phase 2 POC, randomized, double-blinded, placebo-controlled, multicenter clinical

trial to evaluate the safety, tolerability, and efficacy of multiple dose regimens of IV empasiprubart in adults with DM. A

total of 56 adult participants with a clinical diagnosis of DM and active muscle disease will be randomized (1:1:1:1) to

one of four treatment arms (three empasiprubart dose regimens and one placebo arm). Participants will receive loading

doses on days 1 and 8, followed by maintenance doses every four weeks until the end of the 52-week treatment phase.

The primary objective is to evaluate safety and tolerability. The secondary objective is to evaluate clinical efficacy, using

the mean TIS at weeks 13, 25, and 52 as endpoint.


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CIDP

Overview

Please refer to “Item 4.B — efgartigimod Indications” (CIDP) for more information on CIDP.

Phase 3 EMVIGORATE Clinical Trial

In July 2024, we announced our plan to start a head-to-head Phase 3 development of empasiprubart versus IVIg in CIDP

in 1H 2025.

ARGX-119 Development

ARGX-119 is a humanized agonist mAb that specifically targets and activates MuSK to promote maturation and

stabilization of the neuromuscular junction (NMJ). We plan to develop ARGX-119 in a range of neuromuscular diseases

including CMS, a rare hereditary subtype of MG, ALS, and SMA, all severe neuromuscular indications.

NMJs are specialized synapses formed between motor neurons and muscle cells, which are essential for the ability to

move and breathe. At the NMJ, motor neurons release acetylcholine, which binds to AChRs on the muscle to initiate

muscle contraction. Deficits in the NMJ can cause neuromuscular disorders, which can range in severity from mild to

life-threatening skeletal muscle weakness. MuSK is an essential component for the formation and function of NMJs.

ARGX-119 is the first and highly specific agonist mAb targeting human MuSK being developed for patients with

neuromuscular disease, such as CMS and ALS. This mAb is derived from llamas and discovered using the argenx

SIMPLE ANTIBODY™ platform technology. We developed ARGX-119 through our IIP program in collaboration with

the world leading key opinion leaders on MuSK and the neuromuscular junction, including Professor Steve Burden from

NYU and Professor Verschuuren from LUMC. In collaboration with Professor Burden, it was shown that ARGX-119

holds promising preclinical POC data in Dok7 congenital myasthenic syndrome, observed in a mouse model bearing the

most common patient mutation and in ALS using ALS patient derived NMJ on-a-chip models. Based on these data,

clinical development for ARGX-119 was initiated as activation of MuSK by ARGX-119 may stabilize, mature, and

improve the function of the NMJ in patients with CMS or ALS, significantly reducing weakness and fatigability and

improving quality of life.

A Phase 1 dose-escalation clinical trial in healthy volunteers was completed in 2024; data support advancement in POC

studies.

A Phase 1b and 2a clinical trial in CMS and ALS respectively initiated in 2024 to assess early signal detection in

patients. Early January 2025, we announced SMA as the third indication for ARGX-119 for which we expect to initiate a

POC clinical trial in 2025.

Phase 1b Clinical Trial Design

The Phase 1b, multicenter, randomized, double-blinded, placebo-controlled clinical trial is designed to assess the safety,

tolerability, PK, immunogenicity, and preliminary efficacy of ARGX-119 for the first time in participants with DOK7-

CMS. The clinical trial is designed to demonstrate proof of biology for ARGX-119 through a preliminary evaluation of

its efficacy with measures of muscle weakness and fatigability, activities of daily living, and patient-reported outcomes

of global health in participants with DOK7-CMS. The clinical trial will be up to approximately 11 months long,

comprising the following periods, a screening period: up to 28 days, a treatment period of 12 weeks and a follow-up

period of approximately seven months. At baseline, eligible participants will be randomized in a 4:1 ratio to receive IV

infusions of ARGX-119 or placebo. The primary objective is to evaluate the safety and tolerability of ARGX-119 in

participants with DOK7 CMS. The secondary objective is to assess the PK, immunogenicity of ARGX-and efficacy of

ARGX-119 in participants with DOK7 CMS.

Phase 2a reALiSe Clinical Trial Design

The ReALiSe clinical trial is a Phase 2a, double-blinded, randomized, placebo-controlled, and active-treatment extension

clinical trial to assess the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of ARGX-119 in

participants with amyotrophic lateral sclerosis. The clinical trial is designed to demonstrate proof of ARGX-119 activity

through an evaluation of efficacy by assessing the impact of ARGX-119 on ALS disease outcomes, including muscle

function in participants with ALS. Approximately 60 participants are planned to be enrolled, screened, and randomized

1:1:1:1 to one of three ARGX-119 intravenous dose arms or placebo IV for the double-blinded treatment period. This

clinical trial will last up to 100 weeks. The clinical trial will contain the following periods: a screening period (up to four


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weeks), a double-blinded treatment period (24 weeks), an active-treatment extension period (48 weeks), and a safety-

follow-up period (24 weeks). The primary objective is evaluate the safety and tolerability of ARGX-119 in participants

with ALS. The secondary objective is to assess the efficacy of ARGX-119 on electrophysiological measures of disease

progression in participants with ALS using MScan to measure motor unit number and other MScan‑derived

neurophysiological markers. MScan provides parameters that have been associated with ALS disease progression (i.e.,

motor unit loss and/or enlarged motor units due to reinnervation). Additional exploratory outcome measures, including

SVC and ALSFRS-R, will be used to explore ARGX-119 impact on ALS-relevant outcome measures.

ARGX-213, ARGX-121, ARGX-220 and ARGX-109 Development

We continue to invest in our discovery engine, the IIP, to drive long-term sustainable pipeline growth. Through the IIP,

four new pipeline candidates were nominated in 2023, including: ARGX-213 targeting FcRn and furthering argenx’s

leadership in this new class of medicine; ARGX-121 targeting IgA and ARGX-220, which broaden argenx’s focus

across the immune system; and ARGX-109, targeting IL-6, which plays an important role in inflammation. Preclinical

work is ongoing for each candidate and we expect Phase 1 results in 2025 and 2026.

Antibody Engineering and Other Technology Capabilities

Our Proprietary SIMPLE ANTIBODY™ Platform

Our proprietary SIMPLE ANTIBODY™ platform technology sources V-regions from conventional antibodies existing

in the immune system of outbred llamas. Outbred llamas are those that have been bred from genetically diverse parents,

and each has a different genetic background. The llama produces highly diverse panels of antibodies with a high human

homology in their V-regions when immunized with human disease targets. We then combine these llama V-regions with

Fc regions of fully human antibodies, resulting in antibodies that we then produce in industry-validated production cell

lines. The resulting antibodies are diverse and, due to their similarity to human antibodies, we believe they are well

suited to human therapeutic use. With this breadth of antibodies, we are able to test many different epitopes. Being able

to test many different epitopes with our antibodies enables us to search for an optimized combination of safety, potency

and species cross-reactivity with the potential for maximum therapeutic effect on disease. These antibodies are often

cross-reactive with the rodent version of chosen disease targets. This rodent cross-reactivity enables more efficient

preclinical development of our product candidates because most animal efficacy models are rodent-based. By contrast,

most other antibody discovery platforms start with antibodies generated in inbred mice or synthetic antibody libraries,

approaches that we believe are limited by insufficient antibody repertoires and limited diversity, respectively. Our

SIMPLE ANTIBODY™ platform technology allows us to access and explore a broad target universe, including novel

and complex targets, while minimizing the long timelines associated with generating antibody candidates using

traditional methods.

Our Antibody Engineering Technologies

Through licensing we have obtained access to a broad range of antibody engineering technologies. NHANCE™,

ABDEG™, POTELLIGENT® and the DHS mutations focus on engineering the Fc region of antibodies, while

SMART‑Ig® and ACT‑Ig® technologies allow to make sweeping antibodies.

Fc engineering can augment antibodies interactions with components of the immune system, thereby potentially

expanding the therapeutic index of our product candidates by modifying their half-life, tissue penetration, rate of disease

target clearance and potency. For example, our NHANCE™ and ABDEG™ engineering technologies enable us to

modulate the interaction of the Fc region with FcRn, which is responsible for regulating half-life, tissue distribution and

PD properties of IgG antibodies. Similarly, the POTELLIGENT® engineering technology modulates the interaction of

the antibody Fc region with receptors located on specialized immune cells known as natural killer (NK) cells. These NK

cells can destroy the target cell, resulting in enhanced antibody-dependent cell-mediated cytotoxicity (ADCC).

NHANCE™ and ABDEG™: Modulation of Fc Interaction with FcRn.


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An illustration of the FcRn-mediated antibody recycling mechanism is shown in Figure 4. [1] Serum proteins, including

IgG antibodies, are routinely removed from the circulation by cell uptake. [2] Antibodies can bind to FcRn, which serves

as a dedicated recycling receptor in the endosomes, which have an acidic environment, and then [3A] return to the

circulation by binding with their Fc region to FcRn. [3B] Unbound antibodies end up in the lysosomes and are degraded

by enzymes. Because this Fc/FcRn interaction is highly pH-dependent, antibodies tightly bind to FcRn at acidic pH (pH

6.0) in the endosomes but release again at neutral pH (pH 7. 4) in the circulation.

Figure 4: The FcRn-mediated recycling mechanism

NHANCE™

NHANCE™ refers to two mutations that we introduce into the Fc region of an IgG antibody. NHANCE™ is designed to

extend antibody serum half-life and increase tissue penetration. In certain cases, it is advantageous to engineer antibodies

that remain in the circulation longer, allowing them to potentially exert a greater therapeutic effect or be dosed less

frequently. As shown in Figure 5, [1] NHANCE™ antibodies bind to FcRn with higher affinity, specifically under acidic

pH conditions. [2] Due to these tighter bonds, NHANCE™ FcRn-mediated antibody recycling is strongly favored over

lysosomal degradation, although some degradation does occur. [3] NHANCE™ allows a greater proportion of antibodies

to return to the circulation potentially resulting in increased bioavailability and reduced dosing frequency. ARGX-109,

empasiprubart and a number of our discovery-stage programs utilize NHANCE™.


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Figure 5: NHANCE™ mutations favor the FcRn-mediated recycling of IgG antibodies.

ABDEG™

ABDEG™ refers to five mutations that we introduce in the Fc region that increase its affinity for FcRn at both neutral

and acidic pH. In contrast to NHANCE™, ABDEG™-modified Fc regions remain bound to FcRn if the pH changes,

occupying FcRn with such high affinity that they deprive endogenous IgG antibodies of their recycling mechanism,

leading to enhanced clearance of such antibodies by the lysosomes. Some diseases mediated by IgG antibodies are

directed against self-antigens. These self-directed antibodies are referred to as autoantibodies. We use our ABDEG™

technology to reduce the level of these pathogenic autoantibodies in the circulation by increasing the rate at which they

are cleared by the lysosomes. ABDEG™ is a component in a number of our products and product candidates, including

efgartigimod.

As shown in Figure 6, our ABDEG™ technology can also be used with our pH-dependent SIMPLE ANTIBODY™

generated antibodies in a mechanism referred to as sweeping. Certain antibodies generated through the SIMPLE

ANTIBODY™ platform bind to their target in a pH-dependent manner. These antibodies [1] bind tightly to a target at

neutral pH while in circulation, and [2] release the target at acidic pH in the endosome. [3] The unbound target is

degraded in the lysosome. [4] However, when equipped with our ABDEG™ technology, the therapeutic antibodies

remain tightly bound to FcRn at all pH levels and are not degraded themselves. Instead, they are returned to the

circulation where they can bind new targets. We believe this is especially useful in situations where high levels of the

target are circulating or where the target needs to be cleared very quickly from the system.


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Figure 6: SIMPLE ANTIBODY™ and ABDEG™ platform technologies work in concert to sweep diseases targets.

POTELLIGENT®

POTELLIGENT® modulates the interaction of the Fc region with the Fc gamma receptor IIIa located on specialized

immune cells, known as NK cells. These NK cells can destroy the target cell, resulting in enhanced ADCC.

POTELLIGENT® changes the Fc structure by excluding a particular sugar unit such that it enables a tighter fit with the

Fc gamma receptor IIIa. The strength of this interaction is a key factor in determining the killing potential of NK cells.

An independent publication reported that the exclusion of this sugar unit of the Fc region increases the ADCC-mediated

cell-killing potential of antibodies by 10- to 1000-fold. cusatuzumab and ARGX-111 utilize POTELLIGENT® (source:

Expert Opin Biol Ther 2006; 6:1161-1173; http://www.tandfonline.com/doi/full/10.1517/14712598.6.11.1161%20).

SMART-Ig®, ACT-Ig® and DHS

In 2020, we entered into a research license and option agreement with Chugai under which we may access Chugai’s

SMART-Ig® and ACT-Ig®. In 2020, we also entered into a non-exclusive research agreement with the Clayton

Foundation under which we may access the Clayton Foundation’s proprietary DHS mutations to extend the serum half-

life of therapeutic antibodies.

SC drug delivery technologies

We have exclusive access to Halozyme’s ENHANZE® SC drug delivery technology for the FcRn and C2 targets and

four additional targets. ENHANZE® has the potential to shorten drug administration time, reduce healthcare practitioner

time, and offer additional flexibility and convenience for patients.

In addition, in April 2021, we entered into the Elektrofi Agreement with Elektrofi to explore new SC formulations

utilizing Elektrofi’s high concentration technology for efgartigimod, and up to one additional target.

For more information on our collaborations, please refer to “Item 4.B. — Business Overview — Collaboration

Agreements” and to “Item 4.B. — Business Overview — License Agreements”.

Partnered Programs

Refer to “Item 4.B. — Business Overview — Collaboration Agreements” and to “Item 4.B. — Business Overview —

License Agreements” for a description of collaboration and license agreements that we have entered into to further

leverage our IIP.


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Strategy and Objectives

•Our goal is to transform the lives of at least 50,000 patients and their communities before 2030 by providing them

with life-changing medicines built on scientific breakthroughs in immunology. To reach this goal, we plan to deliver

a set of different strategies:

•Maximize the VYVGART® opportunity: redefine treatment expectations for MG and CIDP, and deliver 6 additional

labelled indications We plan to do this through our differentiated scientific and clinical activities and our commercial

execution to drive VYVGART preference. Our PFS with PDUFA Date in April 2025 as a perfect example of our

continued innovation for the patient experience. Beyond neurology, we plan to establish argenx and VYVGART in

rheumatology as we prepare for data in Myositis and SjD, while also maximizing the therapeutic potential of

VYVGART in other indications through the execution of multiple Phase 2 and Phase 3 studies.

•Maximize the empasiprubart opportunity: establish its potential as a pipeline-in-a-product We plan to develop argenx

as scientific leader in complement inhibitions and elevate the differentiation story. In particular, we have advanced

the clinical development of empasiprubart in MMN, currently in Phase 3, DGF in the context of kidney transplants

and DM, currently in Phase 2, and expect to start a registrational clinical trial for our fourth selected indication, CIDP

in 2025. For both MMN and CIDP we will prepare for launches, building on key elements of the VYVGART

playbook.

•Build a sustainable, diversified portfolio of breakthrough and differentiated antibody-based products We plan to

further advance ARGX-119 to a differentiated first-in-class MuSK agonist in multiple indications (CMS, ALS, SMA,

1 new indication), maximize our leadership position in the FcRn space through multiple generations of projects (e.g.

ARGX-213), substantially grow our clinical portfolio of differentiated pipeline-in-a-product opportunities

(ARGX-109, ARGX-121, ARGX-220, ARGX-213, other), create an exciting portfolio of promising new assets

(through our IIP) and advance our clinical trial designs and speed.

•Grow a unique, global biotech company by scaling the argenx Way: one company, one plan, on a mission to achieve

the unthinkable We plan to embed the argenx Way throughout the organization, who we are through our cultural

pillars and how we work through our operating principles. We want to demystify innovation and make it everyone’s

business, strengthen the ‘winning’ competencies to share the future of argenx and advance our partnership approach

to access. To be able to continue in this way, we plan to remain a magnet for talent and create unlimited opportunities

for growth and development of our people, an important driver of developing the business.

•Ensure long-term sustainability We plan to continue to seek out, listen to and prioritize on behalf of the patient in all

what we do, accelerate the science of immunology by being an active and trusted partner in the global immunology

ecosystem through high-quality publications and patent applications, elevate and expand our relationships with

regulatory, payors and policy stakeholders and create long-term shareholder value.

•In our 2030 vision, we aim to build on our strong strategic pillars to have a continuous pipeline of innovation,

strengthen our FcRn leadership and scale in a disciplined way. Our goal is to have 5 new molecules in Phase 3

development, 10 labelled indications and reaching 50,000 patients who are on treatment by 2030.

Competitive position

We participate in a highly innovative industry characterized by a rapidly growing understanding of disease biology,

quickly changing technologies, strong intellectual property barriers to entry, and a multitude of companies involved in

the creation, development and commercialization of novel therapeutics. Many of these companies are highly

sophisticated and often strategically collaborate with each other.

Competition in the autoimmune field is intense and involves multiple monoclonal antibodies (mAbs), other biologics and

small molecules either already marketed or in development by many different companies, including large pharmaceutical

companies. We compete with a wide range of biopharmaceutical companies, who are developing products for the

treatment of gMG, CIDP, ITP and other autoimmune diseases, including products that are in the same class as

VYVGART, as well as products that are similar to some of our product candidates. We are aware of several FcRn

inhibitors that are in clinical development or marketed. Competitive product launches may erode future sales of our

products, including our existing products and those currently under development, or result in unanticipated product

obsolescence. Such launches continue to occur, and potentially competitive products are in various stages of

development. We could also face competition for use of limited international infusion sites, particularly in new markets


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as competitors launch new products. We cannot predict with accuracy the timing or impact of the introduction of

competitive products that treat diseases and conditions like those treated by our products or product candidates. In

addition, our competitors compete with us to recruit and retain qualified scientific and management personnel, establish

clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or

necessary for, the development of our products. Please refer to “Item 3.D. — Risk Factors — Risk Factors Related to

Commercialization of argenx's Products and Product Candidates, Including for New Indications — We face significant

competition for our drug discovery and development efforts” for further details on the competition we face.

Manufacturing and Supply

We utilize third-party contract manufacturers who act in accordance with the FDA’s current good manufacturing

practices (cGMPs) for the manufacture of drug substance and drug product. We continue to build our global network of

contract manufacturers to support the development and commercialization of our products. We work with Lonza teams

based in Slough, UK, Portsmouth, U.S., Singapore and Visp, Switzerland for activities relating to the development of

cell banks, development of our manufacturing processes and the manufacturing of drug substance, thereby using

validated and scalable systems broadly accepted in our industry. In 2022, we started our collaboration with FUJIFILM

Diosynth Biotechnologies Denmark ApS (Fujifilm) based in Hillerød, Denmark, for activities relating to the large-scale

manufacturing of efgartigimod drug substance. We use additional contract manufacturers to fill, label, package, store and

distribute (investigational) drug products.

Intellectual Property

Introduction

We strive to protect and maintain exclusivity for the proprietary technologies that we believe are important to our

business, patients, and shareholders. We continue to pursue and maintain patent protection intended to cover core

platform technologies incorporated into, or used to produce, our product candidates and commercial products. We will

seek protection for our innovations in key global jurisdictions. We continue to focus our exclusivity strategies on all

aspects of our assets, including our compositions of matter, methods of use for our approved products, and other

inventions that are important to our business (e.g., the patient innovations described in our product labels/product inserts

and our core manufacturing technologies).

Our intellectual property portfolio continues to grow and keep pace with the innovations arising from our discovery,

development, and commercial efforts. We expect the total volume of patent positions under our management to increase

each year as our pipeline evolves. We currently oversee more than 500 pending applications and granted patents. More

importantly, as we continue to innovate for patients, we will work to protect our patient innovations with new intellectual

property filings to enable future reinvestment for patients.

In addition to patent protection, we rely on trademarks and trade secrets to protect aspects of our business that are not

amenable to, or that we do not consider appropriate for, patent protection, including certain aspects of our llama

immunization and antibody affinity maturation approaches.

Our commercial success depends in part upon our ability to obtain and maintain exclusivity, including regulatory

exclusivities, patent, and other proprietary protection for commercially important technologies, inventions and know-

how related to our business. We will defend and enforce our intellectual property rights, particularly our patent rights,

and preserve the confidentiality of our trade secrets while operating without infringing valid and enforceable intellectual

property rights of others. Specifically, we are materially dependent on regulatory, patent and other proprietary protection

related to our core platform technologies, described in “Item 4.B. — Business Overview — Intellectual Property —

Platform Technologies” below and our product candidates, as described in “Item 4.B. — Business Overview —

Intellectual Property — Our internal Programs” below and “Item 4.B. — Business Overview — Intellectual Property —

Our Partnered Programs” below.

The patent positions for biotechnology companies like us are generally uncertain and can involve complex legal,

scientific, and factual issues. In addition, the coverage recited in the claims in a patent application can be significantly

reduced before a patent is issued, and claim scope can be reinterpreted and even challenged after issuance. As a result,

we cannot guarantee that any of our platform technologies and product candidates, or products will be protectable or

remain protected by enforceable patents. We cannot predict whether pending patent applications will issue as patents in

any particular jurisdiction or whether the claims of any issued patents will provide sufficient protection from

competitors. Any patents we hold may be challenged, circumvented, or invalidated by third parties.

The term of individual patents depends on the patent laws in the countries in which they are obtained. In most countries,

the patent term is 20 years from the earliest date of filing a non-provisional patent application.


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In the U.S., the term of a patent covering an FDA-approved drug may be eligible for a limited patent term extension

under the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act) as compensation for

the loss of patent term during the FDA regulatory review process as described in “Item 4.B. — Business Overview —

Regulation — Licensure and Regulation of Biologics in the U.S.” below. Similar provisions are available in the EU and

in other jurisdictions to extend the term of a patent that covers an approved drug or its use. It is possible that issued U.S.

patents covering each of our products/product candidates may be entitled to patent term extensions. If our product

candidates receive FDA approval, we intend to apply for patent term extensions, if available, to extend the term of

patents that cover the approved product candidates and/or their uses. We also intend to seek patent term extensions in

any jurisdictions where available. There is no guarantee that the applicable authorities, including the FDA, will agree

with our assessment of whether such extensions should be granted, and if granted, the length of such extensions.

Platform Technologies

With regard to our platform technologies, we own or control intellectual property rights directed to our SIMPLE

ANTIBODY™ discovery platform, the ABDEG™ and NHANCE™ technologies.

With regard to our SIMPLE ANTIBODY™ discovery platform, we have a broad patent portfolio providing exclusivity

on the SIMPLE ANTIBODY™ platform. We expect to enjoy exclusivity under this patent portfolio until between 2029

and 2033.

With regard to the ABDEG™ platform, we co-own the technology with the University of Texas Southwestern Medical

Center and enjoy certain exclusive license rights. We have a broad patent portfolio covering the composition of matter

and uses of certain FcRn antagonists to achieve certain biological effects. The composition of matter and other relevant

patents in the U.S. expire in 2036 whereas in many other countries the base expiry date is 2034.

With regard to the NHANCE™ platform, we exclusively licensed two U.S. patents from the University of Texas

Southwestern Medical Center with composition of matter claims directed to an IgG molecule comprising a variant

human Fc domain, and method of use claims directed to a method of blocking FcRn function in a subject by providing to

the subject such an IgG molecule. The U.S. patents are expected to expire earliest in 2027 to 2028. The patent family

also includes a granted European patent.

Our Internal Programs

efgartigimod

efgartigimod incorporates the ABDEG™ platform technology. We anticipate several more patient innovations to evolve

during development for which we will seek additional patent protection.

Our ARGX-109 Product Candidate

With regard to our wholly-owned ARGX-109 product candidate, we have one patent family with composition of matter

claims directed to ARGX-109. The patent family has a base expiry date in 2033. We anticipate several more patient

innovations to evolve during development for which we will seek additional patent protection. Furthermore, ARGX-109

incorporates or employs the SIMPLE ANTIBODY™ platform technology and the NHANCE™ platform technology.

empasiprubart Product Candidate

With regard to the empasiprubart product candidate, we own or have rights to multiple patent families (including one in-

licensed patent family from Broteio) with several granted patents and pending patent applications in multiple

jurisdictions in North America, South America, the EU and Asia, directed to composition of matter claims and method

of treatment claims. The in-licensed patent family from Broteio has granted patents in several countries/regions and has a

base expiry date in 2034. Additional patent families include granted patents with base expiry dates in 2039 and 2040. We

anticipate several more patient innovations to evolve during development for which we will seek additional patent

protection. empasiprubart product candidate incorporates or employs the NHANCE™ platform technology.

Our ARGX-119 Product Candidate

With regard to the ARGX-119 product candidate, we in-licensed patent families from/with NYU Langone Health, a U.S.

medical center based in New York, and additional patent families from/with the LUMC, with a U.S. granted patent and

several pending applications in multiple jurisdictions. We anticipate several more patient innovations to evolve during

development for which we will seek additional patent protection.

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Our ARGX-118 Product Candidate

With regard to the ARGX-118 product candidate, we co-own a patent portfolio with VIB, an inflammation research

center in Ghent, Brussels, and Ghent University, with one U.S. granted patent and pending patent applications in

multiple jurisdictions in North America, South America, the EU and Asia. The patent family has a base expiry date in

2039.

Our Partnered Programs

Our cusatuzumab (ARGX-110) Product Candidate

With regard to the cusatuzumab product candidate, we have a broad patent portfolio that include claims to the

composition of matter, uses of the molecule, and other important inventions. The issued U.S. patents expire in 2032 and

2033, without taking a potential patent term extension into account. cusatuzumab incorporates or employs the SIMPLE

ANTIBODY™ and POTELLIGENT® platform technologies.

Our ARGX-115 (ABBV-151) Product Candidate

With regard to the ARGX-115 (ABBV-151) product candidate that we co-own with, and exclusively license from, the

Ludwig Institute for Cancer Research and UCL, we have a patent portfolio that includes a U.S. patent with a base expiry

date in 2034, without taking a potential patent term extension into account. There is a second family with meaningful

patent coverage to the composition of matter and epitope claims that are expected to expire in 2036 and 2038.

Furthermore, ARGX-115 (ABBV-151) incorporates or employs the SIMPLE ANTIBODY™ platform technology.

Our ARGX-112 (LP-0145) Product Candidate

With regard to the ARGX-112 (LP-0145) product candidate, we have one patent family with composition of matter

claims directed to an antibody that binds human IL-22R. The patent family has a base expiry date in 2037. Furthermore,

ARGX-112 (LP-0145) incorporates the SIMPLE ANTIBODY™ platform technology.

Collaborations and licenses

We follow a disciplined strategy to maximize the value of our pipeline. We plan to retain all development and

commercialization rights to those products and product candidates that we believe we can commercialize successfully, if

approved.

We have partnered, and plan to continue to partner, to develop products and product candidates that we believe have

promising utility in disease areas or have patient populations that may benefit from resources of other biopharmaceutical

companies. We expect to continue to collaborate selectively with pharmaceutical and biotechnology companies to

leverage our platform technology and accelerate product candidate development.

We are also party to several license agreements under which we license patents, patent applications and other intellectual

property to third parties. We have also entered into several license agreements under which we license patents, patent

applications and other intellectual property from third parties. License agreements can relate to research and

development and/or commercialization of the relevant product candidates (and technologies) or products. The licensed

intellectual property covers some of our product candidates and some of the antibody engineering technologies that we

use. Some of these licenses impose various diligence and financial payment obligations on us. We expect to continue to

enter into these types of license agreements in the future.

We have entered into multiple collaboration agreements with pharmaceutical partners and license agreements, as

described below.

OncoVerity for cusatuzumab

In 2022, we, the University of Colorado Anschutz Medical Campus and the University of Colorado Health (UCHealth)

created an asset-centric spin-off, OncoVerity, Inc (OncoVerity), focused on optimizing and advancing the development

of cusatuzumab, a novel anti-CD70 antibody, in acute myeloid leukemia (AML). OncoVerity is an entity of co-creation,

combining the extensive translational biology insights from Dr. Clayton Smith, M.D. from the University of Colorado

with our experience on the CD70/CD27 pathway.


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In 2023, we granted an exclusive license for cusatuzumab to OncoVerity and provided, together with a joint venture of

University of Colorado Health and University License Equity Holdings, Inc. on the University of Colorado Anschutz

Medical Campus, and funding for ongoing clinical development of cusatuzumab.

In 2024, we participated in a further funding round to support the continued, ongoing, clinical development of

cusatuzumab by OncoVerity.

Our Strategic Partnership with LEO Pharma for ARGX-112 (LP0145)

In May 2015, we entered into a collaboration agreement with LEO Pharma A/S (LEO Pharma) to develop and

commercialize ARGX-112 (LP0145) for the treatment of dermatologic indications involving inflammation (LEO

Pharma Collaboration Agreement). ARGX-112 (LP0145) employs our SIMPLE ANTIBODY™ technology and blocks

the IL-22R in order to neutralize the signaling of cytokines implicated in autoimmune diseases of the skin. LEO Pharma

funded more than half of all product development costs up to clinical trial application (CTA) approval of a first product

in a Phase 1 clinical trial, with our share of such costs capped, which was achieved in April 2018. Since then, LEO

Pharma has been solely responsible for funding the clinical development of the program. In May 2021, CTA approval of

a Phase 2a clinical trial for LP0145 was received.

In September 2022, LEO Pharma, exercised its option to obtain, and was granted an exclusive, worldwide license to

further develop and commercialize ARGX-112 against payment of a €5.0 million option fee to us. LEO Pharma assumed

full responsibility for the continued development, manufacture and commercialization of such product and is subject to

diligence obligations in respect of continuation of development and commercialization of such product. We are eligible

to receive additional development, regulatory and commercial milestone payments in aggregate amount of up to €120.0

million, as well as tiered royalties on product sales at percentages ranging from the low single digits to the low teens,

subject to customary reductions.

Unless earlier terminated, the term of the LEO Pharma Collaboration Agreement ends upon the later of (i) the expiration

of the last license granted under the agreement, and (ii) the fulfilment of all payment obligations under the agreement.

LEO Pharma may terminate the LEO Pharma Collaboration Agreement for any reason upon prior written notice to us.

LEO Pharma’s royalty payment obligations expire, on a product-by-product and country-by-country basis, upon the later

of (i) a time when no valid claims covering such product, and (ii) (a) in major market countries with no composition of

matter patent covering such product, the expiration of the data exclusivity period or (b) in countries that are not major

market countries, a double-digit number of years after the first commercial sale of such product sold in that country.

Our Strategic Partnership with Zai Lab for efgartigimod

Pursuant to the Zai Lab Agreement, Zai Lab obtained the exclusive right to develop and commercialize efgartigimod in

Greater China. Zai Lab will also contribute patients to our global Phase 3 clinical trials of efgartigimod. Our Zai Lab

strategic collaboration allows us to accelerate development of efgartigimod into new autoimmune indications with Zai

Lab taking operational leadership of selected Phase 2 POC Clinical trials.

We are eligible to receive a one-time sales based milestone and tiered royalties (mid-teen to low-twenties on a

percentage basis) based on annual net sales of efgartigimod in Greater China thereafter.

Our Strategic Partnership with AbbVie for ARGX-115 (ABBV-151)

In April 2016, we entered into a collaboration agreement with AbbVie to develop and commercialize ARGX-115

(ABBV-151) as a cancer immunotherapy against the novel target glycoprotein A repetitions predominant (GARP) (the

AbbVie Collaboration Agreement). ARGX-115 (ABBV-151) employs our SIMPLE ANTIBODY™ platform technology

and works by stimulating a patient’s immune system after a tumor has suppressed the immune system by co-opting

immunosuppressive cells such as regulatory T cells. Under the terms of the AbbVie Collaboration Agreement, we were

responsible for conducting and funding all ARGX-115 (ABBV-151) research and development activities up to

completion of investigational new drug (IND) enabling studies.

AbbVie has exercised its option and obtained a worldwide, exclusive license to the ARGX-115 (ABBV-151) program to

develop and commercialize products and has assumed development obligations, including the sole responsibility for all

research, development and regulatory costs relating to ARGX-115 (ABBV-151)-based products. Subject to the

continuing progress of ARGX-115 (ABBV-151) by AbbVie, we are eligible to receive development, regulatory and

commercial milestone payments in aggregate amounts of up to $110 million, $190 million and $325 million,

respectively, as well as tiered royalties on product sales at percentages ranging from the mid-single digits to the lower

teens, subject to customary reductions.


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Pursuant to the AbbVie Collaboration Agreement, we have the right, on a product-by-product basis, to co-promote

ARGX-115 (ABBV-151) based products in the European Economic Area (EEA) and Switzerland and to combine the

product with our own future oncology programs (if any). The co-promotion effort would be governed by a co-promotion

agreement negotiated in good faith by the parties.

Unless earlier terminated upon mutual agreement, for material breach or as otherwise specified in the AbbVie

Collaboration Agreement, the term of the license agreement ends, with respect to the ARGX-115 (ABBV-151) program,

upon fulfilment of all payment obligations under the agreement.

AbbVie may terminate the AbbVie Collaboration Agreement for any reason upon prior written notice to us. AbbVie’s

royalty payment obligations expire, on a product-by-product and country-by-country basis, on the date that is the later of

(i) such time as there are no valid claims covering such product, (ii) expiration of regulatory or market exclusivity in

respect of such product or (iii) 10 years after the first commercial sale of such product sold in that country under the

AbbVie Collaboration Agreement.

Our Exclusive License with Elektrofi for efgartigimod

In April 2021, we entered into the Elektrofi Agreement with Elektrofi to explore new SC formulations utilizing

Elektrofi’s high concentration technology for efgartigimod, and up to one additional target. The Elektrofi-enabled

formulations are aimed to promote additional optionality for patients through at-home and self-administration

capabilities.

Under the terms of the Elektrofi Agreement, we made an upfront payment and committed to future milestones payments

across both targets pending achievement of pre-defined development, regulatory, and commercial milestones. Elektrofi

is also eligible to receive a mid-single digit royalty on sales of commercialized products.

Our collaboration with Genmab

In 2023, we entered into a collaboration with Genmab to jointly discover, develop and commercialize novel therapeutic

antibodies with applications in immunology, as well as in oncology therapeutic areas. The multiyear collaboration is

expected to leverage the antibody engineering expertise and knowledge of disease biology of both companies to

accelerate the identification and development of novel antibody therapeutic candidates with a goal to address unmet

patient needs in immunology and cancer. Under the terms of the collaboration, we and Genmab each have access to the

suites of proprietary antibody technologies of both companies to advance the identification of lead antibody candidates

against differentiated disease targets.

Our Non-Exclusive Research License and Option Agreement with Chugai for SMART-Ig® and ACT-Ig®

In September 2020, we entered into a non-exclusive research license and option agreement with Chugai, allowing us to

access Chugai’s SMART-Ig® and ACT-Ig® engineering technologies for conducting feasibility clinical trials. These

technologies are designed to enable us to make sweeping antibodies and expand the therapeutic index of our product

candidates, which is the ratio between toxic and therapeutic dose, by potentially modifying their half‑life, tissue

penetration, rate of disease target clearance and potency.

Our Non-exclusive License with the Clayton Foundation for DHS mutations

In October 2020, we entered into a non-exclusive research agreement with the Clayton Foundation relating to the non-

exclusive in-license for Clayton Foundation’s proprietary DHS mutations to extend the serum half-life of therapeutic

candidates.

Our Exclusive License with Halozyme for ENHANZE®

In February 2019, we entered into an in-license agreement with Halozyme for the use of certain patents, materials and

know-how owned by Halozyme and relating to its ENHANZE®, for application in the field of prevention and treatment

of human diseases (the ENHANZE® License Agreement). Pursuant to the ENHANZE® License Agreement, we were

granted exclusive rights to apply ENHANZE® to biologic products against pre-specified targets, in order to research,

develop and commercialize SC formulations of our therapeutic antibody-based product candidates.

Our first therapeutic target for which we received an exclusive license from Halozyme was FcRn, which allows us to

apply ENHANZE® to efgartigimod and any other product candidates selective and specific for FcRn. Moreover, the

breadth of our exclusive license to FcRn precludes either Halozyme itself or any of its current or future partners from

utilizing ENHANZE® in the context of an FcRn-targeted product. Our second therapeutic target for which we received


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an exclusive license from Halozyme was human C2 associated with the product candidate empasiprubart, which is being

developed to treat severe autoimmune diseases. Pursuant to the ENHANZE® License Agreement, we also have the right

to nominate future targets for an exclusive ENHANZE® license if the target in question has not already been licensed by

Halozyme or is not already being pursued by Halozyme.

In October 2020, we expanded our collaboration with Halozyme for ENHANZE® drug delivery technology to include

three additional exclusive targets upon nomination bringing the total to six potential targets. From the effective date of

the ENHANZE® License Agreement, we have a seven-year period in which to conduct research and preclinical trials on

other target-specific molecules in combination with ENHANZE®.

In September 2024, we expanded the existing global collaboration and license agreement with Halozyme by nominating

four additional targets for a total of six, including FcRn and C2.

The royalty rate for all products under the agreement is a tiered low-to-mid-single digit rate based on target and annual

net sales until expiration of Halozyme's ENHANZE® related patents, when the rate will be reduced in one or more steps.

Royalties will be paid for the longer of 10 years from the first commercial sale or until the expiration of the last valid

claim of a co-formulation patent.

Pursuant to the ENHANZE® License Agreement, we have the right to grant sublicenses to our subsidiaries and to third

parties both for research/preclinical work (for example, to subcontractors) and for development and commercialization.

Halozyme provides dedicated specialist support to us which it has accrued over 10 years of licensing ENHANZE® to its

collaborators.

We have diligence obligations with respect to the continuation of development and commercialization of product

candidates, but we are not obligated to utilize ENHANZE® for every product candidate directed to a given exclusive

target(s).

We may terminate the ENHANZE® License Agreement at any time, either in its entirety or on a target-by-target basis,

by sending Halozyme prior written notice. Absent early termination, the ENHANZE® License Agreement will

automatically expire upon the expiry of our royalty payment obligations under the agreement. In the event the

ENHANZE® License Agreement is terminated for any reason, the license granted to us would terminate but Halozyme

would grant our sublicensees a direct license following such termination. In the event the ENHANZE® License

Agreement is terminated other than for our breach, we would retain the right to sell licensed products then on hand for a

certain period of time post-termination.

As also set out in “Item 6.A — DIRECTORS AND SENIOR MANAGEMENT” below, our non-executive director in the

Board of Directors (Non-Executive Director) James Daly previously served as a non-executive member of the board of

directors of Halozyme. Mr. Daly did not participate in any discussions and decision making relating to the ENHANZE®

License Agreement. The ENHANZE® License Agreement with Halozyme was not a related party transaction in

accordance with IAS 24 - Related Party Disclosures, since Mr. Daly, in his role as Non-Executive Director, did not

control or have significant influence over argenx or Halozyme.

Our Exclusive License with Agomab for ARGX-114 (AGMB-101)

In March 2019, we entered into an exclusive out-license with Agomab for the use of certain patent rights relating to our

proprietary suite of technologies for the development and commercialization of a series of agonistic anti-MET SIMPLE

ANTIBODY™ generated antibodies, including ARGX-114 (AGMB-101), a halofuginone-mimetic antibody directed

against the MET receptor. Agomab is required to use commercially reasonable efforts to develop and commercialize at

least one licensed product. In connection with our entry into this agreement, we received a profit-sharing certificate

which entitles us to 20% of all distributions to Agomab’s shareholders (which shall be reduced to 10% following the

filing of an IND and is subject to further adjustment upon the occurrence of certain financings). Upon the occurrence of

a qualified initial public offering of Agomab, the profit-sharing certificate will automatically be converted into the

equivalent number of ordinary shares in Agomab. This agreement is subject to mutual termination for material breach or

insolvency and automatically expires upon the expiration of the last to expire of our licensed patent rights.

Our Exclusive License with Broteio for empasiprubart

In March 2017, we entered into a collaboration with Broteio in connection with our IIP, to develop an antibody against a

novel target in the complement cascade, empasiprubart (Broteio Agreement). Under the Broteio Agreement, we have

jointly developed the complement-targeted antibody and established preclinical POC using our proprietary suite of

technologies. Upon successful completion of these preclinical studies, we exercised an exclusive option to in-license the

program in March 2018 and assumed responsibility for further development and commercialization. Pursuant to the

Broteio Agreement, we are obligated to make milestone payments upon the occurrence of certain development

milestones (up to an aggregate of €4.0 million), commercialization milestones (up to an aggregate of €10.0 million) and


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pay tiered royalties on net sales in the low single digits. We may terminate the Broteio Agreement for convenience upon

90 days prior written notice. The Broteio Agreement is also subject to mutual termination for material breach or

insolvency and automatically expires upon the expiration of our financial obligations thereunder.

Our Exclusive License with VIB for ARGX-118

In November 2016, we entered into a collaboration under our IIP with VIB vzw (VIB) to develop antibodies against

Galectin-10, the protein of Charcot-Ley-den Crystals, which play a major role in severe asthma and the persistence of

mucus plugs, including ARGX-118 (VIB Agreement). Pursuant to the VIB Agreement, we are jointly developing

antibodies against Galectin-10 using our proprietary suite of technologies. Upon successful completion of this initial

research, we exercised an exclusive option to in-license the program and assumed responsibility for further development

and commercialization. Under the VIB Agreement, including as amended in November 2018, we are obligated to make

milestone payments upon the occurrence of certain development milestones (up to an aggregate of €4.0 million),

commercialization milestones (up to an aggregate of €11.0 million) and pay tiered royalties on net sales in the low single

digits. We may terminate the VIB Agreement for convenience upon 90 days prior written notice. The VIB Agreement is

also subject to mutual termination for material breach, insolvency or certain patent challenges and automatically expires

upon the expiration of VIB’s licensed patent rights.

Our Exclusive License with the University of Texas for NHANCE™ and ABDEG™

In February 2012, we entered into an exclusive in-license with the Board of Regents of the University of Texas System

(UT BoR) for the use of certain patent rights relating to the NHANCE™ platform for any use worldwide (the UT

Agreement). The UT Agreement was amended on December 23, 2014 to also include certain additional patent rights

relating to the ABDEG™ platform. Upon commercialization of any of our products that use the in-licensed patent rights,

we will be obligated to pay UT BoR a percentage of net sales as a royalty until the expiration of any patents covering the

product. This royalty varies with net sales volume and is subject to an adjustment for royalties we receive from a

sublicensee of our rights under the UT Agreement, but in any event does not exceed 1%. In addition, we must make

annual license maintenance payments to UT BoR until termination of the UT Agreement and we have assumed certain

development and commercial milestone payment and reimbursement obligations. We also have diligence requirements

with respect to development and commercialization of products which use the in-licensed patent rights.

Pursuant to the UT Agreement, we may grant sublicenses to third parties. If we receive any non-royalty income in

connection with such sublicenses, we must pay UT BoR a percentage of such income varying from low-middle single

digits to middle-upper single digits depending on the nature of the sublicense. Such fees are waived if a sublicensee

agrees to pay the milestone payments as set forth in the UT Agreement.

We may unilaterally terminate the UT Agreement for convenience upon prior written notice. Absent early termination,

the UT Agreement will automatically expire upon the expiration of all issued patents and filed patent applications within

the patent rights covered by the UT Agreement. Our royalty payment obligations expire, on a product-by-product and

country-by-country basis, at such time as there are no valid claims covering such product.

Our Non-Exclusive License with BioWa and Non-Exclusive Commercial Licenses with BioWa and Lonza for

POTELLIGENT®

In October 2010, we entered into a non-exclusive license agreement with BioWa, Inc. (BioWa) for the use of certain

patents and know-how owned by BioWa and relating to its POTELLIGENT® platform technology, for use in the field of

prevention and treatment of human diseases. Pursuant to this agreement, we are granted a non-exclusive right to use

POTELLIGENT® to research and develop antibodies and products containing such antibodies using POTELLIGENT®.

In 2013 and 2014, we entered into non-exclusive license agreements for POTELLIGENT® CHOK1SV with BioWa and

Lonza Sales AG (Lonza) for the further development, manufacturing and commercialization of ARGX-110 and

ARGX-111, respectively (the POTELLIGENT® License Agreements).

Upon commercialization of our products developed using POTELLIGENT®, we will be obligated to pay BioWa and

Lonza a percentage of net sales of a licensed product as a royalty. This royalty varies with net sales volume, ranging in

the low single digits, and it is reduced by half if during the following 10 years from the first commercial sale of the

product in a country the last valid claim within the licensed patent(s) that covers the product expires or ends. In addition,

we must make annual research license maintenance payments which cease with commencement of our royalty payments

to BioWa. We have diligence requirements with respect to the continuation of development and commercialization of

products. We have also assumed certain development, regulatory and commercial milestone payment obligations and

must report on our progress toward achieving these milestones on an annual basis. Milestones to BioWa are to be paid

on a commercial target-by-commercial target basis, and we are obligated to make milestone payments in aggregate

amounts of up to $36 million per commercial target should we achieve annual global sales of over $1 billion.


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Pursuant to the POTELLIGENT® License Agreements, we have the right to grant sublicenses to third parties. BioWa

retains a right of first negotiation for the exclusive right to develop and commercialize, in certain countries only, any

product we develop using POTELLIGENT®.

We may terminate the POTELLIGENT® License Agreements at any time by sending BioWa and Lonza prior written

notice. Absent early termination, the POTELLIGENT® License Agreements will automatically expire upon the expiry of

our royalty obligations under the POTELLIGENT® License Agreements. In the event a POTELLIGENT® License

Agreement is terminated for any reason, the license granted to us would terminate but BioWa would grant our

sublicensees a direct license following such termination. In the event the POTELLIGENT® License Agreement is

terminated other than for our breach or insolvency, we would retain the right to sell licensed products then on hand for a

certain period of time post-termination.

Our non-exclusive license with Lonza for Multi-product GS Xceed®-License

On February 4, 2015, we entered into a non-exclusive multi-product in-license agreement with Lonza (the Multi-Product

License) for use of Lonza’s proprietary glutamine synthetase gene expression system known as GS Xceed® consisting of

Chinese hamster ovary cell line and the vectors for the manufacturing of drug substance. This system is used for the

manufacturing of, amongst others, efgartigimod, empasiprubart and ARGX-119.

Pursuant to the Multi-Product License, we have the right to grant sublicenses to certain pre-approved third parties

without prior written consent of Lonza, but otherwise we must obtain Lonza’s prior written consent.

We have assumed certain development, regulatory and commercial milestone payment obligations to Lonza. We are

required to pay such milestones using this system.

We may terminate the Multi-Product License on a product-by-product basis by giving Lonza prior written notice. Lonza

may terminate the Multi-Product License solely in case of breach or insolvency events. Absent early termination, the

Multi-Product License will automatically expire upon the expiry of the last valid claim for such product. We or our

strategic partners would retain the right to sell the respective products then on hand post-termination.

Our Collaboration with Université Catholique de Louvain (UCL) and Sopartec S.A. (Sopartec) for GARP

In January 2013, we entered into a collaboration and exclusive product license agreement with UCL and its technology

transfer company Sopartec to discover and develop novel human therapeutic antibodies against GARP (GARP

Agreement). Pursuant to the GARP Agreement, each party is responsible for all of its own costs in connection with the

activities assigned to it under a mutually agreed research plan.

In January 2015, we exercised the option we were granted under the GARP Agreement to enter into an exclusive,

worldwide commercial in-license for use of certain GARP-related intellectual property rights owned by UCL and the

Ludwig Institute for Cancer Research to further develop and commercialize licensed products, including the GARP-

neutralizing antibody ARGX-115 which was discovered under the original collaboration (GARP License). Upon the

expiration of the GARP Agreement, the GARP License will become a fully paid-up, perpetual worldwide exclusive

license under the GARP intellectual property for any purpose, subject to UCL’s retention of non-commercial research

rights.

Pursuant to the GARP License, we may grant sublicenses to third parties and affiliates of such third parties. In 2016, we

entered into an exclusive collaboration and license agreement with AbbVie regarding ARGX-115. From any income we

receive in connection with these sublicenses, such as in connection with AbbVie Collaboration Agreement, we must pay

Sopartec a percentage of that income in the lower teen digit range. Royalty payment obligations expire on a product-by-

product and country-by-country basis when there are no valid claims covering the ARGX-115 product. We also have

diligence obligations with respect to the continued development and commercialization of ARGX-115 products.

Our Exclusive Licenses with NYU Langone Health and LUMC for ARGX-119

In 2019 and 2020, we entered into collaboration and exclusive license agreements with NYU Langone Health and

LUMC, respectively, under our IIP to develop antibodies targeting the MuSK, for the treatment neuromuscular diseases,

which play a major role at the neuromuscular junction (NYU and LUMC Agreements). Pursuant to the NYU and LUMC

Agreements, we, NYU and LUMC jointly developed antibodies against MuSK using our proprietary suite of

technologies. Under the NYU and LUMC Agreements, as amended, we are obligated to make milestone payments upon

the occurrence of certain development milestones, commercialization milestones and pay tiered royalties on net sales in

the low single digits.

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Trade Secret Protection

In addition to patent protection, we rely on trade secret protection to ensure exclusivity for our proprietary information

that is not amenable to, or that we do not consider appropriate for, patent protection, including, for example, certain

aspects of our llama immunization and antibody affinity maturation approaches. However, trade secrets can be difficult

to protect. Although we take steps to protect our proprietary information, including restricting access to our premises and

our confidential information, as well as entering into agreements with our employees, consultants, advisors and potential

collaborators, third parties may independently develop the same or similar proprietary information or may otherwise gain

access to our proprietary information. As a result, we may be unable to meaningfully protect our trade secrets and

proprietary information.

Regulation

Government authorities in the U.S., at the federal, state and local level, and in the EU and its Member States, and other

countries and jurisdictions, extensively regulate, among other things, the research, development, testing, manufacture,

quality control, approval, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing,

post-approval monitoring and reporting, and import and export of pharmaceutical products, including biological

products. In addition, many countries and jurisdictions regulate the pricing of pharmaceutical products. The processes for

obtaining marketing approvals in the U.S. and in other countries and jurisdictions, along with subsequent compliance

with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial personnel

and financial resources, and breach of which can result in enforcement activity under civil, administrative and / or

criminal law.

Licensure and Regulation of Biologics in the U.S.

In the U.S., biological products used for the prevention, treatment, or cure of a disease or condition in a human being are

subject to regulation under the U.S. Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations.

Biologics are approved for marketing under provisions of the Public Health Service Act (PHSA) via biologics license

applications (BLAs).

An applicant seeking approval to market and distribute a new biologic in the U.S. generally must satisfactorily complete

each of the following steps:

•preclinical laboratory tests, animal studies and formulation studies all performed in accordance with applicable

requirements, including the GLPs;

•submission to the FDA of an IND application for human clinical testing, which contains results of the preclinical

tests, together with manufacturing information and analytical data and must become effective before human clinical

trials may begin;

•approval by an institutional review board (IRB) representing each clinical site before each clinical trial may be

initiated;

•performance of adequate and well-controlled human clinical trials to establish the safety, potency and purity of the

product candidate for each proposed indication, in accordance with good clinical practices (GCPs);

•preparation and submission to the FDA of a BLA for a biological product requesting marketing for one or more

proposed indications, including submission of detailed information on the manufacture and composition of the

product in clinical development and proposed labeling;

•one or more FDA inspections of the manufacturing facility or facilities, including those of third parties, at which the

product, or components thereof, are produced to assess compliance with cGMP requirements and to assure that the

facilities, methods and controls are adequate to preserve the product’s identity, potency, quality and purity;

•FDA inspections of the clinical trial sites and/or sponsor to assure compliance with GCPs, and the integrity of clinical

data in support of the BLA;

•payment of user fees and securing FDA approval of the BLA and licensure of the new biological product; and

•compliance with any post-approval requirements, including the potential requirement to implement a risk evaluation

and mitigation strategy (REMS) and any post-approval studies required by the FDA.

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Human Clinical Trials in Support of a BLA

Clinical trials typically are conducted in three sequential phases, but the phases may overlap or be combined. Additional

clinical trials may be required after approval.

•Phase 1 clinical trials are initially conducted in a limited population to test the product candidate for safety, including

adverse effects, dose tolerance, absorption, metabolism, distribution, excretion and PD in healthy humans or, in

patients.

•Phase 2 clinical trials are generally conducted in a limited patient population to identify possible adverse effects and

safety risks, evaluate the efficacy of the product candidate for specific targeted indications and determine dose

tolerance and optimal dosage. Multiple Phase 2 clinical trials may be conducted by the sponsor to obtain information

prior to beginning larger Phase 3 clinical trials.

•Phase 3 clinical trials are undertaken within an expanded patient population to gather additional information about

safety and effectiveness necessary to evaluate the overall benefit-risk relationship of the drug and to provide an

adequate basis for physician labeling.

A sponsor who wishes to conduct a clinical trial outside the U.S. may, but is not required to, obtain FDA clearance to

conduct the clinical trial under an effective IND. If a foreign clinical trial is not conducted under an IND, the sponsor

may submit data from the clinical trial to the FDA in support of the BLA so long as the clinical trial is well-designed and

well-conducted in accordance with GCPs, including review and approval by an independent ethics committee, and the

FDA is able to validate the clinical trial data through an onsite inspection, if necessary. In some cases, the FDA may

approve a BLA for a product candidate but require the sponsor, or the sponsor may otherwise choose, to conduct

additional clinical trials to further assess, amongst other things, the product candidate’s safety and effectiveness after

approval. Such post-approval clinical trials are typically referred to as Phase 4 clinical trials. Failure to exhibit due

diligence with regard to conducting required Phase 4 clinical trials could result in FDA enforcement, including

withdrawal of approval for products.

Review and Approval of a BLA

The results of product candidate development, preclinical testing and clinical trials, including negative or ambiguous

results as well as positive findings, are submitted to the FDA as part of a BLA requesting a license to market the product.

The BLA also must contain extensive manufacturing information and detailed information on the composition of the

product and proposed labeling as well as payment of a user fee, unless exempt.

The FDA has 60 days after submission of the application to conduct an initial review to determine whether the BLA is

sufficient to file based on the agency’s threshold determination that it is sufficiently complete to permit substantive

review. If the FDA determines the BLA is not sufficiently complete, it will refuse to file the BLA. Once the submission

has been filed, the FDA begins an in-depth review of the application. Under the goals agreed to by the FDA under the

PDUFA, the FDA has 10 months from the filing date in which to complete its initial review of a standard application and

respond to the applicant, and six months from the filing date for an application granted priority review. The FDA does

not always meet its PDUFA goal dates and they may be extended in certain circumstances.

After the FDA’s evaluation of the application and accompanying information, including the results of any necessary

inspections, the FDA will issue an approval letter, or a complete response letter. An approval letter authorizes

commercial marketing of the product with specific prescribing information for specific indications. Under the PHSA, the

FDA may approve a BLA if it determines that the product is safe, pure and potent and the facility where the product will

be manufactured meets standards designed to ensure that it continues to be safe, pure and potent. If the application is not

approved, the FDA will issue a complete response letter, which will identify the deficiencies in the application. Sponsors

that receive a complete response letter may resubmit to the FDA information addressing the issues identified by the

FDA, withdraw the application, or request a hearing. Even if a BLA is resubmitted with data and information addressing

the deficiencies, the FDA may decide that the BLA does not satisfy the criteria for approval.

The FDA may also refer the application to an advisory committee, consisting of independent experts, for review,

evaluation and recommendation as to whether the application should be approved, particularly when applications present

difficult or novel questions of safety or efficacy. The FDA is not bound by the recommendations of an advisory

committee, but it considers such recommendations carefully when making decisions.

If the FDA approves a new product, it may require testing and surveillance programs to monitor the product after

commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms,

including REMS, to help ensure that the benefits of the product outweigh the potential risks. REMS can include

medication guides, communication plans for healthcare professionals, and/or elements to assure safe use. This can

include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under


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certain circumstances, special monitoring, and the use of patent registries. The FDA may prevent or limit further

marketing of a product based on the results of post-market studies or surveillance programs.

After approval, many types of changes to the approved product, such as adding new indications, certain manufacturing

changes, and additional labeling claims, are subject to further testing requirements and FDA review and approval.

Expedited Development and Review Programs

The FDA is authorized to designate products meeting certain criteria for expedited development and review programs.

Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets

the conditions for qualification, or the time period for FDA review or approval may not be shortened.

The FDA may designate a product for fast track review if it is intended, whether alone or in combination with one or

more other products, for the treatment of a serious or life-threatening disease or condition, and demonstrates the potential

to address unmet medical needs for such a disease or condition. For fast track products, sponsors may have more

frequent interactions with the FDA and the FDA may initiate review of sections of a fast track product’s application

before the application is complete (rolling review). The sponsor must also provide, and the FDA must approve, a

schedule for the submission of the remaining information and the sponsor must pay applicable user fees. However, the

FDA’s PDUFA clock for a rolling review application does not begin until the last section of the application is submitted.

A product may be designated as a breakthrough therapy if it is intended, either alone or in combination with one or more

other products, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that

the product may demonstrate substantial improvement over existing therapies on one or more clinically significant

endpoints, such as substantial treatment effects observed early in clinical development. The FDA may take certain

actions with respect to breakthrough therapies, including holding meetings with the sponsor throughout the development

process; providing timely advice to the product sponsor regarding development and approval; involving more senior

staff in the review process; assigning a cross-disciplinary project lead for the review team; and taking other steps to

design the clinical trials in an efficient manner. Breakthrough therapy designation also comes with all of the benefits of

fast-track designation.

The FDA may designate a product for priority review if it is a product that treats a serious condition and, if approved,

would provide a significant improvement in safety or effectiveness. The FDA determines, on a case-by-case basis,

whether the proposed product represents a significant improvement when compared with other available therapies.

Significant improvement may be illustrated by evidence of increased effectiveness in the treatment of a condition,

elimination or substantial reduction of a treatment-limiting product reaction, documented enhancement of patient

compliance that may lead to improvement in serious outcomes, or evidence of safety and effectiveness in a new

subpopulation. A priority designation is intended to direct overall attention and resources to the evaluation of such

applications, and to shorten the FDA’s goal for taking action on a marketing application from 10 months to six months

after accepting the application for filing.

The FDA may grant accelerated approval to a product for a serious or life-threatening condition that provides meaningful

therapeutic advantage to patients over existing treatments based upon a determination that the product has an effect on a

surrogate endpoint that is reasonably likely to predict clinical benefit or on a clinical endpoint that can be measured

earlier than an effect on irreversible morbidity or mortality (IMM) and that is reasonably likely to predict an effect on

IMM or other clinical benefit (intermediate clinical endpoint), taking into account the severity, rarity, or prevalence of

the condition and the availability or lack of alternative treatments. Products granted accelerated approval must meet the

same statutory standards for safety and effectiveness as those granted traditional approval.

For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radio-

graphic image, physical sign, or other measure that is thought to predict clinical benefit but is not itself a measure of

clinical benefit. Surrogate endpoints can often be measured more easily or more rapidly than clinical endpoints. An

intermediate clinical endpoint is a measurement of a therapeutic effect that is considered reasonably likely to predict the

clinical benefit of a product, such as an effect on IMM.

The accelerated approval pathway is most often used in settings in which the course of a disease is long and an extended

period of time is required to measure the intended clinical benefit of a product, even if the effect on the surrogate or

intermediate clinical endpoint occurs rapidly. Thus, accelerated approval has been used extensively in the development

and approval of products for treatment of a variety of cancers in which the goal of therapy is generally to improve

survival or decrease morbidity and the duration of the typical disease course requires lengthy and sometimes large

clinical trials to demonstrate a clinical or survival benefit.

The accelerated approval pathway is usually contingent on a sponsor’s agreement to conduct, in a diligent manner, a

post-approval confirmatory clinical trial or studies to verify and describe the product’s clinical benefit. These

confirmatory clinical trials must be completed with due diligence, and the FDA may require that the confirmatory


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clinical trial be designed, initiated, and/or fully enrolled prior to, or within a certain period following, approval. The FDA

must also specify the conditions of any required post-approval clinical trial. Sponsors are required to submit progress

reports for required post-approval studies, and the failure to conduct with due diligence a required post-approval clinical

trial, including a failure to meet any required conditions specified by the FDA, or to submit timely reports, are prohibited

acts under the FDCA. Failure to conduct required post-approval studies, or confirm a clinical benefit during post-

marketing studies, would allow the FDA to withdraw the product from the market on an expedited basis. Unless

otherwise informed by the FDA, all promotional materials for product candidates approved under accelerated approval

are subject to prior review by the agency.

Orphan Drug Designation and Exclusivity

Orphan drug designation in the U.S. is designed to encourage sponsors to develop products intended for rare diseases or

conditions. In the U.S., a rare disease or condition is statutorily defined as a condition that affects fewer than 200,000

individuals in the U.S. or that affects more than 200,000 individuals in the U.S. and for which there is no reasonable

expectation that the cost of developing and making available the product for the disease or condition will be recovered

from sales of the product in the U.S. An application for designation as an orphan product can be made any time prior to

the filing of an application for approval to market the product. If the FDA grants orphan drug designation, the generic

identity of the product and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation qualifies

a company for tax credits. Orphan drug designation does not convey any advantage in or shorten the duration of the

regulatory review and approval process.

If a product that has orphan drug designation subsequently receives the first FDA approval for the disease or condition

for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not

approve any other application to market the same drug for the same indication for seven years from the date of such

approval, except in limited circumstances, such as a showing of clinical superiority to the product with orphan

exclusivity by means of greater effectiveness, greater safety or providing a major contribution to patient care, or if the

holder of the orphan exclusivity is unable to supply the market. Competitors, however, may receive approval of either a

different product for the same indication or the same product for a different indication, which could be used off-label in

the orphan indication. Orphan drug exclusivity also could block the approval of one of our products for seven years if a

competitor obtains approval before we do for the same product, as defined by the FDA, for the same indication we are

seeking approval, or if our product is determined to be contained within the scope of the approval of the competitor’s

product for the same indication or disease.

Post-Approval Regulation

If regulatory approval for marketing of a product or new indication for an existing product is obtained, the sponsor will

be required to comply with all post-approval regulatory requirements, including those that the FDA has imposed as part

of the approval process. The sponsor will be required to report certain adverse reactions and production problems to the

FDA, provide updated safety and efficacy information and comply with requirements concerning advertising and

promotional labeling. Manufacturers and other parties involved in the drug supply chain for prescription drug and

biological products must also comply with product tracking and tracing requirements and must notify the FDA of

counterfeit, diverted, stolen and intentionally adulterated products or products that are otherwise unfit for distribution in

the U.S. Manufacturers and certain of their subcontractors are required to register their establishments with the FDA and

certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for

compliance with ongoing regulatory requirements, including cGMPs. Accordingly, the sponsor and its third-party

manufacturers must continue to expend time, money and effort in the areas of production and quality control to maintain

compliance with cGMPs and other regulatory requirements.

A biological product may also be subject to official lot release, meaning that the manufacturer is required to perform

certain tests on each lot of the product before it is released for distribution. If the product is subject to official lot release,

the manufacturer must submit samples of each lot, together with a release protocol showing a summary of the history of

manufacture of the lot and the results of all of the manufacturer’s tests performed on the lot, to the FDA. The FDA may

in addition perform certain confirmatory tests on lots of some products before releasing the lots for distribution. Finally,

the FDA will conduct laboratory research related to the safety, purity, potency and effectiveness of biological products.

Any distribution of biological products and samples must comply with the U.S. Prescription Drug Marketing Act and the

PHSA.

Once approval of a BLA is granted, the FDA may revoke or suspend the approval if compliance with regulatory

requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery

of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with

manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved

labeling to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks; or

imposition of distribution or other restrictions under a REMS program. FDA also has authority to require post-market

studies, in certain circumstances, on reduced effectiveness of a product and may require labeling changes related to new


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reduced effectiveness information. Other potential consequences for a failure to maintain regulatory compliance include,

among other things:

•restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market, or

product recalls;

•fines, untitled letters, or warning letters;

•refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or

revocation of product license approvals;

•product seizure or detention, or refusal to permit the import or export of products; or

•injunctions or the imposition of civil or criminal penalties.

Pediatric Studies and Exclusivity

Under the Pediatric Research Equity Act of 2003, as amended (PREA), certain BLAs or supplements thereto must

contain data that are adequate to assess the safety and effectiveness of the product for the claimed indications in all

relevant pediatric sub-populations, and to support dosing and administration for each pediatric subpopulation for which

the product is safe and effective. Sponsors must also submit an initial Pediatric Study Plan (PSP), within 60 days of an

end-of-Phase 2 meeting or, if there is no such meeting, as early as practicable before the initiation of the Phase 3 or

Phase 2/3 clinical trial. The initial PSP plans must contain an outline of the proposed pediatric clinical trial or studies the

applicant plans to conduct, including clinical trial objectives and design, any deferral or waiver requests and other

information required by regulation. The applicant and the FDA must agree upon a final plan. The FDA or the applicant

may request an amendment to the plan at any time.

The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all

pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data

requirements. Unless otherwise required by regulation, PREA does not apply to a biologic for an indication for which

orphan designation has been granted, except that PREA will apply to an original BLA for a new active ingredient that is

orphan-designated if the biologic is a molecularly targeted cancer product intended for the treatment of an adult cancer

and is directed at a molecular target that FDA determines to be substantially relevant to the growth or progression of a

pediatric cancer.

Pediatric exclusivity is another type of non-patent regulatory exclusivity in the U.S. and, if granted for a biologic,

provides for the attachment of an additional six months of protection to the term of any existing regulatory exclusivity

(i.e., reference product exclusivity and orphan drug exclusivity) that has at least 9 months left to expiration. This six-

month exclusivity may be granted if a BLA sponsor submits reports of pediatric studies that fairly respond to a written

request from the FDA for such studies, were conducted in accordance with commonly accepted scientific principles and

protocols, and have been reported in accordance with filing requirements.

Biosimilars and Exclusivity

The Biologics Price Competition and Innovation Act (BPCIA) established a regulatory scheme authorizing the FDA to

approve biosimilars and interchangeable biosimilars.

Under the BPCIA, an applicant may submit an application for licensure of a biologic product that is “biosimilar to” or

“interchangeable with” a previously approved biological product or “reference product.” For the FDA to approve a

biosimilar product, it must find that the proposed biosimilar is highly similar to the reference product notwithstanding

minor differences in clinically inactive components and that there are no clinically meaningful differences between the

product and the reference product in terms of safety, purity, or potency. For the FDA to approve a biosimilar product as

interchangeable with a reference product, the agency must find that the biosimilar product is biosimilar to the reference

product and that it can be expected to produce the same clinical results as the reference product in any given patient, and

(for products administered multiple times) that the biologic and the reference biologic may be alternated or switched

after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to

exclusive use of the reference biologic without such alternation or switch.

Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following

the date of approval of the reference product. The FDA may not approve a biosimilar product until 12 years from the

date on which the reference product was approved. Even if a product is considered to be a reference product eligible for

exclusivity, another company could market a competing version of that product if the FDA approves a full BLA for such

product containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to


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demonstrate the safety, purity and potency of their product. We note that patent positions may be available to preclude

the introduction into commerce of such competing product independent of any FDA exclusivities. The BPCIA also

created certain exclusivity periods for biosimilars approved as interchangeable products. Products deemed

interchangeable by the FDA may be substituted by pharmacies as dictated by individual state law.

U.S. Patent Term Restoration

Depending upon the timing, duration, and specifics of FDA review and approval of our product candidates, some of our

U.S. patents may be eligible for limited patent term extension under the Hatch-Waxman Act that permits restoration of

the patent term of up to five years as compensation for patent term lost during the FDA regulatory review process.

Patent-term restoration, however, cannot extend the remaining term of a patent beyond a total of 14 years from the

product’s approval date, and only those claims covering such approved product, a method for using it or a method for

manufacturing it may be extended. The patent-term restoration period is generally one-half the time between the

effective date of an IND and the submission date of a BLA plus the time between the submission date of a BLA and the

approval of that application, except that the review period is reduced by any time during which the applicant failed to

exercise due diligence. Only one patent applicable to an approved biologic is eligible for the extension and the

application for the extension must be submitted within 60 days of approval from FDA and prior to the expiration of the

patent. The U.S. Patent and Trademark Office (USPTO), in consultation with the FDA, reviews and approves the

application for any patent term extension or restoration. In the future, we may apply for restoration of patent term for our

currently owned or licensed patents to add patent life beyond the current expiration date, depending on the expected

length of the clinical trials and other factors involved in the filing of the relevant BLA.

Regulation and Procedures Governing Approval of Medicinal Products in the European Union and the UK

Similar to the U.S., the EU, and the UK comprehensively regulate, among other things, the development, manufacturing,

placing on the market, advertising, distribution, import and export of medicinal products. Particularly, the placing on the

market of a medicinal product for human use in the EU requires a marketing authorization (MA). Main Provisions

governing medicinal products in the EU are Directive 2001/83/EC and Regulation (EC) No 726/2004 (each as amended).

Regulation (EC) No 141/2000 and Regulation (EC) No. 847/2000 (each as amended) are also of particular relevance for

orphan medicinal products. While directives need to be transposed into national law by member states of the EU (EU

Member States) before they are applicable, regulations directly apply in the EU Member States once these have been

enacted.

The process governing approval of MA applications (MAA) for the placing on the market of medicinal products in the

EU and the UK generally follows the same lines as in the U.S. It entails satisfactory completion of pharmaceutical

development, pre-clinical trials and adequate and well-controlled clinical trials to establish the safety and efficacy of the

medicinal product for each proposed indication. The EU also requires the submission to relevant competent authorities

for clinical trials authorization and to the European Medicines Agency (EMA) or to competent authorities in EU member

states and granting of such MA by the EU Commission or relevant national authorities before the medicinal product can

be marketed and sold in the EU or the relevant EU Member States. The below mentioned principles and rules generally

apply within the EEA, i.e., the EU including Iceland, Liechtenstein and Norway.

Following the UK’s departure from the EU, a separate MA is required from the Medicines and Healthcare Products

Regulatory Agency (the MHRA), the UK medicines regulator, in order to place medicinal products on the market in the

Great Britain (England, Wales and Scotland), which has been extended to Northern Ireland following the Windsor

Framework having taken effect (see below)). Under the recently introduced International Recognition Procedure (IRP),

the MHRA may take into account decisions from the EMA (and certain other international regulators) when considering

an application for an MA. In respect of Northern Ireland, the UK government and the EU have agreed to replace the

Northern Ireland Protocol (pursuant to which the EU regulatory framework continued to apply to Northern Ireland) with

the ‘Windsor Framework’. Under the Windsor Framework, the MHRA is responsible for approving all medicinal

products destined for the entire UK market (including Northern Ireland), and the EMA no longer has any role in

approving medicinal products destined for Northern Ireland. The medicines aspects of the Windsor Framework came

into force on January 1, 2025.

Clinical Trial Approval

Both non-clinical and clinical data are generally required to support an MA for a medicinal product in the EU. Non-

clinical investigations are performed to demonstrate the health or environmental safety of new biological substances.

Non-clinical (pharmaco-toxicological) investigations must generally be conducted in compliance with the principles of

good laboratory practice (GLP) as set forth in EU Directive 2004/10/EC (as amended).

Clinical trials are comprehensively regulated under the Clinical Trials Regulation (EU) No 536/2014 (CTR), which

entered into application on January 31, 2022, and (gradually) replaces the Clinical Trials Directive 2001/20/EC (CTD).


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By January 30, 2025, all still ongoing clinical trials under the CTD must be transitioned to the CTR. The CTR, aims to

simplify and streamline the approval of clinical trials in the EU.

As before, many of the legal obligations are on the so-called sponsor, which is defined as the individual, company,

institution, or organization that takes responsibility for the initiation, for the management and for setting up the financing

of a clinical trial. The sponsor must obtain an authorization from the competent authority in the EU Member State(s) in

which the clinical trial will be conducted as well as an approval from the competent national ethics committee in

accordance with relevant national legislation in each of the relevant member states, before the commencement of such

clinical trial.

The CTR also imposes requirements, among others, regarding the conduct of a clinical trial (which must be conducted in

accordance with the protocol and good clinical practice to generate acceptable data for MA submission), safety reporting

of adverse events and reactions, changes to clinical trials, protection and informed consent of clinical trial subjects.

Clinical trials conducted outside the EEA must follow the principles set forth in EU legislation if their results are to be

submitted in an application for an MA in the EU.

Before its exit from the EU, the UK implemented the CTD into national law through the Medicines for Human Use

(Clinical Trials) Regulations 2004 (as amended). The entry into application of the CTR took place after the UK’s

departure from the EU, so it does not apply to Great Britain. The MHRA ran a consultation on reforms to the UK clinical

trials legislation, the outcome of which was published in March 2023. New draft legislation was laid for consideration

before the UK Parliament in mid-December 2024. The draft regulations include a 12-month implementation period. The

UK’s new clinical trials regime is therefore expected to come into force in early 2026 or thereafter.

Orphan Designation and Exclusivity

Regulation (EC) No. 141/2000 and Regulation (EC) No. 847/2000 (each as amended) provide that a product can be

designated as an orphan medicinal product by the EU Commission if its sponsor can establish: (i) that the product is

intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition, (ii) either

(a) the prevalence of the condition is not more than five in ten thousand persons in the EU when the application is made,

or (b) without incentives it is unlikely that the marketing of the product in the EU would generate sufficient return to

justify the necessary investment in its development and (iii) there exists no satisfactory method of diagnosis, prevention,

or treatment of the condition in question that has been authorized in the EU or, if such method exists, the product has to

be of a significant benefit compared to products available for the condition.

An orphan designation provides a number of benefits, including fee reductions and, regulatory assistance. If an MA is

granted for an orphan medicinal product, this generally results in a ten-year period of market exclusivity for the approved

orphan indication. It is, however, not possible to combine non-orphan and orphan indications within the same MA. Thus,

for non-orphan indications treated with the same active pharmaceutical ingredient, a separate MA has to be sought.

Alternatively, the orphan designation may be waived to allow for the addition of non-orphan indications to an existing

MA. As a result, the approved medicinal product would no longer profit from the orphan designation’s benefits.

During an orphan medicinal product’s market exclusivity period, neither the EMA, the EU Commission nor the EU

Member States can accept an application or grant an MA for a “similar medicinal product.” A “similar medicinal

product”, i.e., a medicinal product containing a similar active substance or substances as contained in an authorized

orphan medicinal product, and which is intended for the same therapeutic indication. The market exclusivity period for

the authorized therapeutic indication may, however, be reduced to six years if, at the end of the fifth year, it is

established that the product no longer meets the criteria for orphan designation. For orphan medicinal products intended

for pediatric use, the market exclusivity period may be prolonged by additional two years if they are authorized with a

pediatric indication based on the results from studies conducted under an EMA-approved pediatric investigation plan or

if they are authorized without a pediatric indication but the results of the studies conducted under the EMA-approved

pediatric investigation plan are reflected in the summary of product characteristic and, if appropriate, in the package

leaflet. Market exclusivity may also be revoked in very select cases, such as if (i) it is established that a similar medicinal

product is safer, more effective or otherwise clinically superior; (ii) the MA holder (MAH) for the authorized orphan

medicinal product consents to the second orphan application; or (iii) the MA holder for the authorized orphan medicinal

product cannot supply sufficient quantities. Orphan designation must be requested before submitting an MAA and is

reconfirmed during the MAA process. Orphan designation does not convey any advantage in, or shorten the duration of,

the regulatory review and MA approval process.

Since January 1, 2021, a separate process for orphan designation has applied in Great Britain. There is no pre-marketing

authorization orphan designation (as there is in the EU) and the application for orphan designation is reviewed by the

MHRA, at the time of an MAA for a UK or Great Britain marketing authorization. Until January 1, 2025, a UK-wide

orphan MAA could only be considered in the absence of an active EU orphan designation. From January 1, 2025, MAs

granted for products that fulfil UK orphan criteria are valid UK-wide (including in Northern Ireland), regardless of

whether there is an EU orphan designation or EU authorization as an orphan medicinal product. The criteria are the same


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as in the EU and, following implementation of the Windsor Framework from January 1, 2025, apply to the whole of the

UK. The criteria are that: the medicine must be intended for the treatment, prevention or diagnosis of life-threatening or

chronically debilitating diseases; the prevalence of the condition must be no more than five in 10,000 persons in the UK

or it must be unlikely that the medicine’s marketing would generate sufficient returns to justify the investment needed

for its development; and there must be no satisfactory method of diagnosis, prevention or treatment of the condition

concerned in the UK, or if such method exists the medicine must be of significant benefit to those affected by the

condition.

Marketing Authorization

To obtain an MA for a medicinal product under the EU regulatory framework, an applicant must submit an MAA, either

to the EMA using the centralized procedure or to competent authorities in the EU Member States using the other

procedures (decentralized procedure, national procedure, or mutual recognition procedure). An MA may be granted only

to an applicant established in the EU. Regulation (EC) No. 1901/2006 provides that prior to obtaining an MA in the EU,

an applicant must demonstrate compliance with all measures included in an EMA-approved pediatric investigation plan,

covering all subsets of the pediatric population, unless the EMA has granted a product-specific waiver, class waiver, or a

deferral for one or more of the measures included in the pediatric investigation plan.

The centralized procedure provides for the grant of a single MA by the EU Commission that is valid for all EEA

Member States. Pursuant to Regulation (EC) No. 726/2004 (as amended), the centralized procedure is compulsory for

specific products, including for medicines produced by certain biotechnological processes, products designated as

orphan medicinal products, advanced therapy medicinal products (gene therapy, somatic cell therapy or tissue

engineered products) and products with a new active substance indicated for the treatment of certain diseases, including

products for the treatment of cancer and auto-immune diseases and other immune dysfunctions and neurodegenerative

disorders. The centralized procedure is optional for certain other medicinal products.

Under the centralized procedure, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is responsible

for conducting the assessment of a product to define its risk/benefit profile. The CHMP recommendation is then sent to

the EU Commission, which adopts a decision binding in all EEA Member States. Under the centralized procedure, the

maximum timeframe for the evaluation of an MA application is 210 days, excluding clock stops when additional

information or written or oral explanation is to be provided by the applicant in response to questions asked by the

CHMP, which can considerably extend the 210 days. Accelerated evaluation (150 days excluding clock stops) may be

granted by the CHMP in exceptional cases, when a medicinal product is of major interest from the point of view of

public health and, in particular, from the viewpoint of therapeutic innovation.

MAs have an initial validity for five years, in principle, and they may be renewed after five years on the basis of a

reevaluation of the risk benefit balance by the EMA, or by the competent authority of the EU Member State. Once

renewed, the MA is valid for an unlimited period, unless the EU Commission or the competent authority decides, on

justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal period. Any MA that is

not followed by the placement of the medicinal product on the EU market or on the market of the authorizing EU

Member State(s) within three years after authorization, or if the drug is removed from the market for three consecutive

years, ceases to be valid. In Great Britain, centrally authorized products converted from EU to UK marketing

authorizations will have the same renewal date.

Following the departure of the UK from the EU, the UK is no longer covered by European centralized marketing

authorizations issued by the EMA. As of January 1, 2025, the MHRA regulates medicines through UK-wide MAs and

EU centralized MAs are not valid anywhere in the UK. Instead, medicines that were previously within scope of the EU

centralized procedure are authorized by the MHRA under UK-wide MAs.

European Data and Market Exclusivity

In the EU, innovative medicinal products, approved on the basis of a complete independent data package, qualify for

eight years of data exclusivity upon marketing authorization and an additional two years of market exclusivity (for the

more comprehensive protections applying to orphan medicinal products, please refer to “Item 4.B — Business overview

— Orphan Designation and Exclusivity” above). The data exclusivity, if granted, prevents generic or biosimilar

applicants from referencing the innovator’s preclinical and clinical trial data contained in the dossier of the reference

product when applying for a generic or biosimilar MA in the EU, for a period of eight years from the date on which the

reference product was first authorized in the EU. During the additional two-year period of market exclusivity, a generic

or biosimilar MAA can be submitted, and the innovator’s data may be referenced, but no generic or biosimilar product

can be marketed in the EU until the expiration of the market exclusivity period. The overall ten-year period will be

extended to a maximum of 11 years if, during the first eight years of those 10 years, the MA holder obtains an MA for

one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are

determined to bring a significant clinical benefit in comparison with currently approved therapies. There is no guarantee

that a product will be considered by the EMA to be an innovative medicinal product, and products may not qualify for


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data exclusivity. Even if a product is considered to be an innovative medicinal product so that the innovator gains the

prescribed period of data exclusivity, another company nevertheless could also market another version of the product if

such company obtained an MA based on an MAA with a complete independent data package of pharmaceutical tests,

preclinical tests and clinical trials. Similar arrangements apply in the UK.

Regulatory Requirements after Marketing Authorization

Following MA approval, the MA holder is required to comply with a range of requirements applicable to the

manufacturing, marketing, promotion and sale of the medicinal product. These include compliance with the EU’s

stringent pharmacovigilance or safety reporting rules under Directive 2001/83/EC and Regulation (EU) 726/2004 (each

as amended) and the associated guideline on good pharmacovigilance practices (as amended), pursuant to which post-

authorization studies and additional monitoring obligations can be imposed. In addition, the manufacturing of authorized

medicinal products, for which a separate manufacturer’s license is mandatory, must also be conducted in strict

compliance with the principles of good manufacturing practice (GMP) set forth in Commission Directive 2017/1572

GMP and comparable requirements of other regulatory bodies in the EU, which mandate the methods, facilities and

controls used in manufacturing, processing and packing of products to assure their safety and identity. Further, the

wholesale distribution of authorized medicinal products requires a separate distribution license and must be conducted in

strict compliance with good distribution practice standards. Finally, the marketing and promotion of authorized

medicinal products is strictly regulated under Directive 2001/83/EC, (as amended) and as transposed into national laws.

Potential consequences for a failure to maintain regulatory compliance mainly depend on the relevant regulations in the

EU Member States, but are, for example, in Germany, similar to those in the U.S. Please refer to “Item 4.B — Business

overview — Post-Approval Regulations” above.

Proposal for new EU Pharmaceutical Legislation

On April 26, 2023, the EU Commission has published a proposal for a new directive (COM/2023/192 final) and a new

regulation (COM/2023/193 final), which would revise and replace the existing general pharmaceutical legislation,

including e.g., Directive 2001/83/EC, as well as Regulations (EC) No. 726/2004, No. 141/2000, or No. 1901/2006 (EU

Pharmaceutical Legislation). Proposed amendments include, among others, modifications to the orphan designation

criteria as well as the introduction of a modulated framework for orphan market exclusivity. Regarding the latter, the

regulation proposal envisages a shift to a staggered approach. Those orphan medicinal products that address a high

unmet medical need shall still benefit from a market exclusivity period of ten years. Well-established use orphan

medicinal products will have a five-year market exclusivity period. Nine years of market exclusivity shall apply for all

other orphan medicinal products. In certain cases, exclusivity periods may be prolonged (e.g., obtaining of an MA for

one or more new therapeutic indications).

Other key points of the proposed new EU Pharmaceutical Legislation include new measures to prevent and mitigate

medicine shortages, to simplify the market entry of generics and biosimilars and the introduction of a new data

protection regime for medicinal products. The proposal remains to be agreed and adopted by the European Parliament

and European Council and may therefore be substantially revised before adoption, which is not anticipated before early

2026.

Brexit and the Regulatory Framework in the UK

On January 31, 2020, the UK officially ceased being a Member State of the EU (Brexit). For a period thereafter,

immediate arrangements applied governing pharmaceutical legislation in the UK. However, as from January 1, 2025,

following the implementation of the Windsor Framework, the MHRA is now the only authority approving medicines for

the UK market. The Windsor Framework replaced the Northern Ireland Protocol, under which the EU regulatory

framework continued to apply in Northern Ireland, and made the following key regulatory changes for medicines: (i)

removed EU licensing processes in relation to Northern Ireland for novel medicines; (ii) removed any requirement for

EU Falsified Medicines Directive packaging, labelling and serialization barcode for medicines in Northern Ireland; and

(iii) required all medicines placed on the UK market to be labelled ‘UK Only’, indicating they are not for sale in the

Republic of Ireland or other EU countries. More broadly, with the exception of the CTR, the UK and the EU’s regimes

for the marketing, promotion and sale of medicinal products remain aligned, as the UK’s Human Medicines Regulations

2012 (as amended) implemented prior EU legislation on these topics before Brexit, and remain in force post-Brexit.

However, these regulatory regimes may diverge increasingly in future, now that the UK’s regulatory system is formally

independent from the EU.

Regulation and Procedures Governing Approval of Medicinal Products in Japan

In order to market any medical products in Japan, a company must comply with numerous and varying regulatory

requirements regarding quality, safety and efficacy in the context, among other things, of clinical trials, marketing


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approval, commercial sales and distribution of products. A person who manufactures or markets medical products in

Japan is subject to the supervision of the Ministry of Health, Labour and Welfare (MHLW), primarily under the Act on

Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (Pharmaceutical and Medical Devices

Act). This entails the satisfactory completion of pharmaceutical development, preclinical studies and adequate and well-

controlled clinical trials to establish the safety and efficacy of the medical product for each proposed indication. It also

requires the filing of a notification of clinical trials with the Pharmaceuticals and Medical Devices Agency (Japan)

(PMDA) and the obtaining of marketing approval from the relevant authorities before the product can be marketed and

sold in the Japanese market.

Business License

Under the Pharmaceutical and Medical Devices Act, a company or individual must obtain a Marketing Authorization

Holder (MAH) license from the MHLW to engage in the marketing or provision of medical products. This requirement

applies to medical products that are either manufactured by the company itself outsourced to a third party for

manufacturing or imported.

To manufacture medical products for the Japanese market, a company must obtain a manufacturing license from the

MHLW for each production facility. This license is separate from the marketing authorization and is required for both

domestic and foreign manufacturing sites.

Marketing Approval

Under the Pharmaceutical and Medical Devices Act, it is generally required to obtain marketing approval from the

MHLW for the marketing of each medical product. An application for marketing approval must be made through the

PMDA, which implements a marketing approval review.

Clinical Trial

Under the Pharmaceutical and Medical Devices Act, it is required to file notification of clinical trials with the PMDA.

The data of clinical trials and other pertinent data, which must be attached to an application for marketing approval, must

be obtained in compliance with the standards established by the MHLW, such as GLPs and GCPs stipulated by the

ministerial ordinances of the MHLW.

Regulatory Requirements after Marketing Approval

A MAH that has obtained marketing approval for a new pharmaceutical is subject to re-examination by the PMDA for a

specified period after receiving marketing approval. Such re-examination period for VYVGART is stated to be 10 years

after the marketing approval in January 2022. The purpose of this re-examination process is to ensure the safety and

efficacy of a newly approved pharmaceutical by imposing on the MAH the obligation to gather clinical data for a certain

period after the marketing approval was granted to enable the PMDA to re-examine the product. Results of use and other

pertinent data must be attached to an application for a re-examination. An MAH that has obtained a marketing approval

is also required to investigate, among other things, the results of use and to periodically report to the PMDA pursuant to

the Pharmaceutical and Medical Devices Act.

Price Regulation

Japan's public medical insurance systems cover virtually the entire Japanese population. The public medical insurance

system, however, does not cover any medical product which is not listed on the National Health Insurance (NHI) price

list published by the Minister of the MHLW. Accordingly, an MAH of medical products must first have a new medical

product listed on the NHI price list to obtain coverage under the public medical insurance system. VYVGART was listed

on the NHI price list in April 2022 and the price was adjusted in February 2024. VYVDURA was listed in April 2024.

The NHI price of a medical product is determined either by price comparison of comparable medical products with

necessary adjustments for innovation, usefulness or size of the market; or, in the absence of comparable medical

products, by the cost calculation method, determined after considering of the opinion of the manufacturer. Prices on the

NHI price list are subject to revision, generally once every year, based on the actual prices at which the medical products

are purchased by medical institutions.

Coverage, Pricing and Reimbursement

Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which we may

obtain regulatory approval. Even if our product candidates are approved for marketing, sales of such product candidates


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will depend, in part, on the extent to which third-party payors, including government health programs in the U.S. (such

as Medicare and Medicaid), commercial health insurers, and managed care organizations, provide coverage and establish

adequate reimbursement levels for such product candidates. Moreover, increasing efforts by governmental and third-

party payors in the EU, the U.S. and other markets to cap or reduce healthcare costs may cause such organizations to

limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or

provide adequate payment for our product candidates. We expect to experience pricing pressures in connection with the

sale of any of our product candidates due to the trend toward managed healthcare, the increasing influence of health

maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general,

particularly prescription drugs and surgical procedures and other treatments, has become very intense. As a result,

increasingly high barriers are being erected to the entry of new products.

In the U.S. and markets in other countries, patients generally rely on third-party payors to reimburse all or part of the

costs associated with their treatment. Adequate coverage and reimbursement from governmental healthcare programs,

such as Medicare and Medicaid, and commercial payors is critical to new product acceptance. Patients are unlikely to

use any product candidates we may develop unless coverage is provided and reimbursement is adequate to cover a

significant portion of the cost of such product candidates.

Factors payors consider in determining reimbursement are based on whether the product is (i) a covered benefit under its

health plan; (ii) safe, effective and medically necessary; (iii) appropriate for the specific patient; (iv) cost-effective; and

(v) neither experimental nor investigational.

The Medicare and Medicaid programs increasingly are used as models for how private payors and other governmental

payors develop their coverage and reimbursement policies for drugs and biologics. Some third-party payors may require

pre-approval of coverage for new or innovative devices or drug therapies before they will reimburse healthcare providers

who use such therapies. It is difficult to predict at this time what third-party payors will decide with respect to the

coverage and reimbursement for our product candidates. No uniform policy for coverage and reimbursement for drug

products exists among third-party payors in the U.S. Therefore, coverage and reimbursement for drug products can differ

significantly from payor to payor including formulary tier placement and utilization management requirements (if any).

As a result, the coverage determination process is often a time-consuming and costly process that will require us to

provide scientific and clinical support for the use of our products to each payor separately, with no assurance that

coverage and adequate reimbursement will be applied consistently or obtained in the first instance. The position of a

product on a formulary generally determines the co-payment that a patient will need to make to obtain the product and

can strongly influence the adoption of a product by patients and physicians. Third-party payors may limit coverage to

specific products on a formulary, which might not include all of the approved products for a particular indication.

Additionally, a payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate

will be approved or that cost-sharing will be acceptable for patients. Coverage policies and third-party reimbursement

rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more of our

products for which we or our collaborators receive marketing approval, less favorable coverage policies and

reimbursement rates may be implemented in the future.

Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of

medical products and services and imposing controls to manage costs, especially drugs when an equivalent generic drug

or a less expensive therapy is available. It is possible that a third-party payor may consider our product candidate and

other therapies (in some cases even off-label treatments) as substitutable and only offer to reimburse patients for the less

expensive product. Even if we show improved efficacy or improved convenience of administration with our product

candidate, pricing of existing drugs may limit the amount we will be able to charge for our product candidate. These

payors may deny or revoke the reimbursement status of a given drug product or establish prices for new or existing

marketed products at levels that are too low to enable us to realize an appropriate return on our investment in product

development. If reimbursement is not available or is available only at limited levels, we may not be able to successfully

commercialize our product candidates and may not be able to obtain a satisfactory financial return on products that we

may develop.

In Mainland China, VYVGART has been included in the NRDL for the treatment of adults with gMG who are AChR-

AB+ after going through price negotiations with the National Healthcare Security Administration (NHSA) since January

2024, which means that the price of this drug can be (partly) reimbursed by the social security program of Mainland

China for the treatment of this indication in accordance with relevant rules within certain period. According to the

current regulations of Mainland China, if we want our products in addition to VYVGART to be included in the NRDL or

want VYVGART to be included in the NRDL for the treatment of other indications, we will need to go through price

negotiations with the NHSA, for which purpose we will likely need to significantly reduce their prices. Although the

inclusion of our products in the NRDL may increase the demand for the relevant products, our potential revenue from

the sales of these products may still decrease as a result of lower prices.

Furthermore, rules and regulations regarding reimbursement change frequently, in some cases at short notice, and we

believe that changes in these rules and regulations are likely. Outside the U.S., we will face challenges in ensuring

obtaining adequate coverage and payment for any product candidates we may develop. Pricing of prescription


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pharmaceuticals is subject to governmental control in many countries. In order to secure coverage and reimbursement for

any product that might be approved for sale, we have needed and may need to conduct expensive pharmacoeconomic

studies in order to demonstrate the medical necessity and cost-effectiveness of the product, and the cost of these studies

would be in addition to the costs required to obtain FDA or other comparable marketing approvals. Conducting such

studies could be expensive, involve additional risk and result in delays in our commercialization efforts. Even after

pharmacogenomic studies are conducted, product candidates may not be considered medically necessary or cost-

effective. A decision by a third-party payor not to cover any product candidates we may develop could reduce physician

utilization of such product candidates once approved and have a material adverse effect on our sales, results of

operations and financial condition. Third-party reimbursement and coverage may not be adequate to enable us to

maintain price levels sufficient to realize an appropriate return on our investment in product development. The insurance

coverage and reimbursement status of newly approved products for orphan diseases is particularly uncertain, and failure

to obtain or maintain adequate coverage and reimbursement for any such product candidates could limit our ability to

generate revenue. As noted above, in the U.S., we plan to have various programs to help patients afford our products,

including patient assistance programs and co-pay coupon programs for eligible patients. More specifically, patients can

enroll into MY VYVGART PATH™, a patient support program that provides personalized support from a nurse case

manager and committed support team. In addition to providing support on questions on the treatment and on navigating

the insurance process, the program provides a VYVGART Co-pay Program to eligible patients, aids in referring patients

to charitable foundations that may be able to help with out-of-pocket costs and informs patients of financial assistance

programs that may be available.

The containment of healthcare costs also has become a priority of U.S. federal, state and international governments and

the prices of pharmaceuticals have been a focus in this effort. Governments have shown significant interest in

implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for

substitution of generic products. Net prices for drugs may be reduced by mandatory discounts or rebates required by

government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of

drugs from countries where they may be sold at lower prices than in the U.S. Increasingly, third-party payors are

requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices

charged for medical products. We cannot be sure that reimbursement will be available for any future product candidate

that we commercialize and, if reimbursement is available, the level of reimbursement. In addition, many pharmaceutical

manufacturers must calculate and report certain price reporting metrics to the government, such as average sales price

and best price. Penalties may apply in some cases when such metrics are not submitted accurately and timely. Adoption

of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing

controls and measures, could further limit our potential revenue from the sale of any products for which we may obtain

approval.

The delivery of healthcare in the EU, including the establishment and operation of health services and the pricing and

reimbursement of medicinal products, is almost exclusively a matter for national, rather than EU, provisions and

regulations. National governments and health service providers have different priorities and approaches to the delivery of

healthcare and the pricing and reimbursement of products in that context. Therefore, in the EU, pricing and

reimbursement schemes vary widely from EU Member State to another. Some EU Member States provide that products

may be marketed only after a reimbursement price has been agreed. Some EU Member States may require the

completion of additional studies that compare the cost-effectiveness of a particular product candidate to currently

available therapies (so called health technology assessments) in order to obtain reimbursement or pricing approval. EU

Member States may approve a specific price for a product or may instead adopt a system of direct or indirect controls on

the profitability of the company placing the medicinal product on the market. Other Member States allow companies to

fix their own prices for products but monitor and control prescription volumes and issue guidance to physicians to limit

prescriptions.

Recently, many EU Member States have increased the amount of discounts required on medicinal products and these

efforts could continue as Member States attempt to further manage healthcare expenditures. For example, Germany

recently introduced a specific discount on certain combination products with new active ingredients. The downward

pressure on healthcare costs in general, particularly medicinal prescription products, has become intense. As a result,

increasingly high barriers are being erected to the entry of new products. Political, economic and regulatory

developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement

has been obtained. Reference pricing used by various EU Member States and parallel trade (arbitrage between low-

priced and high-priced Member States) can further reduce prices. Special pricing and reimbursement rules may apply to

orphan medicinal products. Inclusion of orphan drugs in reimbursement systems tend to focus on the medical usefulness,

need, quality and economic benefits to patients and the healthcare system as for any drug. Acceptance of any medicinal

product for reimbursement may come with cost, use and often volume restrictions, which again can vary by country. In

addition, results-based rules of reimbursement may apply. There can be no assurance that any EU Member State that has

price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing

arrangements for any of our products, if approved in those countries. Historically, products launched in the EU do not

follow price structures of the U.S. and generally prices tend to be significantly lower.


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Outside the U.S., international operations are generally subject to extensive governmental price controls and other

market regulations, and we believe the increasing emphasis on cost-containment initiatives in Europe, Canada and other

countries has and will continue to put pressure on the pricing and usage of our product candidates. In many countries, the

prices of medical products are subject to varying price control mechanisms as part of national health systems. Other

countries allow companies to fix their own prices for medical products but monitor and control company profits.

Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to

charge for our product candidates. Accordingly, in markets outside the U.S., the reimbursement for our products may be

reduced compared with the U.S. and may be insufficient to generate commercially reasonable revenue and profits.

Government Pricing and Reimbursement Programs for Marketed Drugs in the U.S.

Medicaid, the 340B Drug Pricing Program, and Medicare

Federal law requires that a pharmaceutical manufacturer, as a condition of having its drug and biological products

receive federal reimbursement under Medicaid and Medicare Part B, must pay rebates to state Medicaid programs for all

units of its covered outpatient drugs dispensed to Medicaid beneficiaries and paid for by a state Medicaid program under

either a fee-for-service arrangement or through a managed care organization. This federal requirement is effectuated

through a Medicaid drug rebate agreement between the manufacturer and the Secretary of U.S. Department of Health

and Human Services (HHS). The Centers for Medicare & Medicaid Services (CMS) administers the Medicaid drug

rebate agreements, which provide, among other things, that the drug manufacturer will pay rebates to each state

Medicaid agency on a quarterly basis and report certain price information on a monthly and quarterly basis. The rebates

are based on prices reported to CMS by manufacturers for their covered outpatient drugs, including average

manufacturer price (AMP) and best price. Effective January 1, 2024, the Medicaid total rebate amount is no longer

capped at 100% of a covered outpatient drug’s AMP, which means that a manufacturer could pay a total rebate amount

on a unit of the drug that is greater than the average price the manufacturer receives for the drug.

The terms of participation in the Medicaid drug rebate program impose an obligation to correct the prices reported in

previous quarters, as may be necessary. Any such corrections could result in additional or lesser rebate liability,

depending on the direction of the correction. In addition to retroactive rebates, if a manufacturer were found to have

knowingly submitted false information to the government, federal law provides for civil monetary penalties for failing to

provide required information, late submission of required information, and false information.

A manufacturer must also participate in a federal program known as the 340B drug pricing program in order for federal

funds to be available to pay for the manufacturer’s drug and biological products under Medicaid and Medicare Part B.

Under this program, the participating manufacturer agrees to charge certain safety net healthcare providers no more than

an established discounted price for its covered outpatient drugs. The formula for determining the discounted price is

defined by statute and is based on the AMP and the unit rebate amount as calculated under the Medicaid drug rebate

program, discussed above. Manufacturers are required to report pricing information to the Health Resources and

Services Administration on a quarterly basis. The Health Resources and Services Administration has also issued

regulations relating to the calculation of the ceiling price as well as imposition of civil monetary penalties for each

instance of knowingly and intentionally overcharging a 340B covered entity.

Federal law also requires that manufacturers report data on a quarterly basis to CMS regarding the pricing of drugs that

are separately reimbursable under Medicare Part B. These are generally drugs and biologics, such as injectable products,

that are administered incident to a physician service and are not generally self-administered. The pricing information

submitted by manufacturers is the basis for reimbursement to physicians and suppliers for drugs covered under Medicare

Part B. Under the Inflation Reduction Act (IRA), manufacturers are also required to provide quarterly rebates for certain

single-source drugs and biologics (including biosimilars) covered under Medicare Part B with prices that increase faster

than the rate of inflation. This requirement started on January 1, 2023 for drugs approved on or before December 1, 2020

and begins six quarters after a drug is first marketed for all other drugs. As with the Medicaid drug rebate program,

federal law provides for civil monetary penalties for failing to provide required information, late submission of required

information, and false information.


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Additionally, the Infrastructure Investment and Jobs Act added a requirement, effective January 1, 2023, for

manufacturers of certain single-source drugs (including biologics and biosimilars) separately paid for under Medicare

Part B for at least 18 months and marketed in single-dose containers or packages (known as refundable single-dose

containers or single-use package drugs) to provide annual refunds for any portions of the dispensed drug that are unused

and discarded if those unused or discarded portions exceed an applicable percentage defined by statute or regulation.

Manufacturers will be subject to periodic audits and those that fail to pay refunds for their refundable single-dose

containers or single-use package drugs shall be subject to civil monetary penalties.

Medicare Part D provides prescription drug benefits for seniors and people with disabilities. Beginning in 2025, the IRA

eliminates the coverage gap phase and associated manufacturer discounts under Medicare Part D, significantly lowers

the enrollee maximum out-of-pocket cost and establishes a new manufacturer discount program, which requires 10%

discounts in the initial phase, and 20% discounts in the catastrophic phase. Although these discounts represent a lower

percentage of enrollees’ costs than coverage gap discounts, the new manufacturer contribution during the catastrophic

phase could be considerable for certain high-cost drugs and the total contributions by manufacturers to a Part D

enrollee’s drug expenses may exceed those currently provided. The IRA also requires manufacturers to provide annual

Medicare Part D rebates for single-source drugs and biological products with prices that increase faster than the rate of

inflation.

The IRA also allows HHS to directly negotiate the selling price of a statutorily specified number of drugs and biologics

each year that CMS reimburses under Medicare Part B and Part D. Only high-expenditure single-source biologics that

have been approved for at least 11 years (7 years for single-source drugs) can qualify for negotiation, with the negotiated

price taking effect two years after the selection year. Negotiations for Medicare Part D products began in 2023 with the

negotiated price taking effect in 2026, and negotiations for Medicare Part B products will begin in 2026 with the

negotiated price taking effect in 2028.

U.S. Federal Contracting and Pricing Requirements

Manufacturers are also required to make their covered drugs, which are generally drugs approved under NDAs or BLAs,

available to authorized users of the Federal Supply Schedule (FSS) of the General Services Administration. The law also

requires manufacturers to offer deeply discounted FSS contract pricing for purchases of their covered drugs by the

Department of Veterans Affairs, the Department of Defense, the Coast Guard, and the Public Health Service (including

the Indian Health Service) in order for federal funding to be available for reimbursement or purchase of the

manufacturer’s drugs under certain federal programs. FSS pricing to those four federal agencies for covered drugs must

be no more than the Federal Ceiling Price (FCP), which is at least 24% below the Non-Federal Average Manufacturer

Price (Non-FAMP) for the prior year. The Non-FAMP is the average price for covered drugs sold to wholesalers or other

middlemen, net of any price reductions.

The accuracy of a manufacturer’s reported Non-FAMPs, FCPs, or FSS contract prices may be audited by the

government. Among the remedies available to the government for inaccuracies is recoupment of any overcharges to the

four specified federal agencies based on those inaccuracies. If a manufacturer were found to have knowingly reported

false prices, in addition to other penalties available to the government, the law provides for significant civil monetary

penalties per incorrect item. Finally, manufacturers are required to disclose in FSS contract proposals all commercial

pricing that is equal to or less than the proposed FSS pricing, and subsequent to award of an FSS contract, manufacturers

are required to monitor certain commercial price reductions and extend commensurate price reductions to the

government, under the terms of the FSS contract Price Reductions Clause. Among the remedies available to the

government for any failure to properly disclose commercial pricing and/or to extend FSS contract price reductions is

recoupment of any FSS overcharges that may result from such omissions.

Healthcare Law and Regulation

Healthcare providers and third-party payors play a primary role in the recommendation and prescription of

pharmaceutical products that are granted marketing approval. Our current and future arrangements with providers,

researchers, consultants, third-party payors and customers are subject to broadly applicable federal and state fraud and

abuse, anti-kickback, false claims, transparency and patient privacy laws and regulations and other healthcare laws and

regulations that may constrain our business and/or financial arrangements. Restrictions under applicable federal and state

healthcare laws and regulations include, without limitation, the following:

•the U.S. federal Anti-Kickback Statute (AKS) prohibits, among other things, persons and entities from knowingly and

willfully soliciting, receiving, offering, or paying remuneration, directly or indirectly, in cash or in kind, to induce or

reward either the referral of an individual for, or the purchase, lease, order or recommendation of, any good facility,

item, or service, for which payment may be made, in whole or in part, under a federal healthcare program such as

Medicare and Medicaid. This statute has been interpreted to apply to arrangements between pharmaceutical

manufacturers on the one hand and prescribers, purchasers formulary managers and other persons and entities on the

other. Although there are a number of statutory exceptions and regulatory safe harbors protecting certain activities


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from prosecution, the exceptions and safe harbors are drawn narrowly, and arrangements may be subject to scrutiny

or penalty if they do not fully satisfy all elements of an available exception or safe harbor. A person or entity can be

found guilty of violating the AKS without actual knowledge of the statute or specific intent to violate it. In addition,

the government may assert that a claim including items or services resulting from a violation of the AKS constitutes a

false or fraudulent claim for purposes of the federal False Claims Act or federal civil money penalties statute.

Violations of the AKS carry potentially significant civil and criminal penalties, including imprisonment, fines,

administrative civil monetary penalties, and exclusion from participation in federal healthcare programs.

•the U.S. federal false claims and civil monetary penalties laws, including the civil False Claims Act and federal civil

monetary penalty laws, which, among other things, impose criminal and civil penalties, including through civil

whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented,

to the U.S. federal government, claims for payment or approval that are false or fraudulent, knowingly making, using

or causing to be made or used, a false record or statement material to a false or fraudulent claim or obligation to pay

or transmit money to the federal government, or from knowingly making a false statement to avoid, decrease or

conceal an obligation to pay money to the U.S. federal government. In addition, the government may assert that a

claim including items and services resulting from a violation of the AKS constitutes a false or fraudulent claim for

purposes of the False Claims Act. Manufacturers can be held liable under the False Claims Act even when they do not

submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent

claims. The False Claims Act also permits a private individual acting as a “whistleblower” to bring qui tam actions on

behalf of the federal government alleging violations of the False Claims Act and to share in any monetary recovery.

When an entity is determined to have violated the federal civil False Claims Act, the government may impose civil

fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare,

Medicaid and other federal healthcare programs;

•the U.S. federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) which imposes criminal and

civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to

defraud any healthcare benefit program, or obtaining by means of false or fraudulent pretenses, representations, or

promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program,

regardless of the pay (e.g., public or private) or knowingly and willfully falsifying, concealing or covering up a

material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare

benefits, items or services relating to healthcare matters; similar to the AKS, a person or entity does not need to have

actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

•HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH)

and its implementing regulations, and as amended again by the Omnibus Rule in 2013, which imposes certain

obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and

transmission of individually identifiable health information without appropriate authorization by covered entities

subject to the Final HIPAA Omnibus Rule, i.e., certain covered health plans, healthcare clearinghouses and healthcare

providers, as well as their business associates, those independent contractors or agents of covered entities that perform

certain services for or on their behalf involving the use or disclosure of individually identifiable health information.

HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties

directly applicable to business associates and possibly other persons, and gave state attorneys general new authority to

file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’

fees and costs associated with pursuing federal civil actions;

•the federal transparency requirements known as the federal Physician Payments Sunshine Act, under the Patient

Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010

(collectively, the ACA), which requires certain manufacturers of drugs, devices, biologics and medical supplies to

report annually to CMS information related to payments and other transfers of value made by that entity to physicians

(currently defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician

providers such as physician assistants and nurse practitioners and teaching hospitals, as well as ownership and

investment interests held by physicians and their immediate family members. Failure to submit required information

may result in civil monetary penalties for all payments, transfers of value or ownership or investment interests that are

not timely, accurately, and completely reported in an annual submission;

•federal government price reporting laws, which require us to calculate and report complex pricing metrics in an

accurate and timely manner to government programs;

•federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities

that potentially harm consumers;

•analogous state and local laws and regulations, including: state anti-kickback and false claims laws; state laws that

require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and

the relevant compliance guidance promulgated by the U.S. federal government, or otherwise restrict payments that

may be made to healthcare providers and other potential referral sources; state and local laws that require the


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licensure of sales representatives; state laws that require drug manufacturers to report information related to payments

and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing

information; state laws governing the privacy and security of health information in certain circumstances, many of

which differ from each other in significant ways and may not have the same effect; and state laws related to insurance

fraud in the case of claims involving private insurers; and

•EU, UK and other foreign law equivalents, including reporting requirements detailing interactions with and payments

to healthcare providers and data privacy and security laws and regulations that may be more stringent than those in

the U.S.

State and foreign laws, including for example the EU General Data Protection Regulation (GDPR), also govern the

privacy and security of health information in some circumstances, many of which differ from each other in significant

ways and often are not preempted by HIPAA, thus complicating compliance efforts. There are ambiguities as to what is

required to comply with these state requirements and if we fail to comply with an applicable state law requirement, we

could be subject to penalties.

We have and will continue to spend substantial time and money to ensure that our business arrangements with third

parties comply with applicable healthcare laws and regulations. Recent healthcare reform legislation has strengthened

these federal and state healthcare laws. Because of the breadth of these laws and the narrowness of the statutory

exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge

under one or more of such laws.

Other laws that may affect our ability to operate include:

•the anti-inducement law prohibits, among other things, the offering or giving of remuneration, which includes,

without limitation, any transfer of items or services for free or for less than fair market value (with limited

exceptions), to a Medicare or Medicaid beneficiary that the person know or should know is likely to influence the

beneficiary’s selection of a particular supplier of items or services reimbursable by a federal or state governmental

program; and

•European and other foreign law equivalents of each of the laws, including reporting requirements detailing

interactions with and payments to healthcare providers.

In the U.S., to help patients afford our approved product, we may utilize programs to assist them, including patient

assistance programs and co-pay coupon programs for eligible patients. Government enforcement agencies have shown

increased interest in pharmaceutical companies’ product and patient assistance programs, including reimbursement

support services, and a number of investigations into these programs have resulted in significant civil and criminal

settlements. In addition, at least one insurer has directed its network pharmacies to no longer accept co-pay coupons for

certain specialty drugs the insurer identified. Our co-pay coupon programs could become the target of similar insurer

actions. In addition, in November 2013, the CMS issued guidance to the issuers of qualified health plans sold through the

ACA’s marketplaces encouraging such plans to reject patient cost-sharing support from third parties and indicating that

the CMS intends to monitor the provision of such support and may take regulatory action to limit it in the future. The

CMS subsequently issued a rule requiring individual market qualified health plans to accept third-party premium and

cost-sharing payments from certain government-related entities. In September 2014, the Office of the Inspector General

of the HHS issued a Special Advisory Bulletin warning manufacturers that they may be subject to sanctions under the

AKS and/or civil monetary penalty laws if they do not take appropriate steps to exclude Part D beneficiaries from using

co-pay coupons. Accordingly, companies exclude these Part D beneficiaries from using co-pay coupons. Additionally,

certain third-party payors are modifying benefit designs based on the availability of manufacturer cost-sharing assistance

(e.g., copay accumulator or maximizer programs). Following a federal district court decision vacating the provisions of

the 2021 Notice of Benefit and Payment Parameter final rule that provided health plans with discretion whether to

include manufacturer assistance toward the cost-sharing limit, CMS stated its intent to address this issue in future

rulemaking. It is possible that changes in insurer policies regarding co-pay coupons and/or the introduction and

enactment of new legislation or regulatory action could restrict or otherwise negatively affect these patient support

programs, which could result in fewer patients using affected products, and therefore could have a material adverse

effect on our sales, business, and financial condition.

Third-party patient assistance programs that receive financial support from companies have become the subject of

enhanced government and regulatory scrutiny. The Office of the Inspector General of the HHS has established

guidelines that suggest that it is lawful for pharmaceutical manufacturers to make donations to charitable organizations

who provide co-pay assistance to Medicare patients, provided that such organizations, among other things, are bona fide

charities, are entirely independent of and not controlled by the manufacturer, provide aid to applicants on a first-come

basis according to consistent financial criteria and do not link aid to use of a donor’s product. However, donations to

patient assistance programs have received some negative publicity and have been the subject of multiple government

enforcement actions, related to allegations regarding their use to promote branded pharmaceutical products over other

less costly alternatives. Specifically, in recent years, there have been multiple settlements resulting out of government


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claims challenging the legality of their patient assistance programs under a variety of federal and state laws. It is possible

that we may make grants to independent charitable foundations that help financially needy patients with their premium,

co-pay, and co-insurance obligations. If we choose to do so, and if we or our vendors or donation recipients are deemed

to fail to comply with relevant laws, regulations or evolving government guidance in the operation of these programs, we

could be subject to damages, fines, penalties, or other criminal, civil, or administrative sanctions or enforcement actions.

We cannot ensure that our compliance controls, policies, and procedures will be sufficient to protect against acts of our

employees, business partners, or vendors that may violate the laws or regulations of the jurisdictions in which we

operate. Regardless of whether we have complied with the law, a government investigation could impact our business

practices, harm our reputation, divert the attention of management, increase our expenses, and reduce the availability of

foundation support for our patients who need assistance.

Violations of these laws or any future enacted laws can subject us to criminal, civil and administrative sanctions

including monetary penalties, damages, fines, disgorgement, individual imprisonment and exclusion from participation

in government funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements and

oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-

compliance with these laws, reputational harm, and we may be required to curtail or restructure our operations.

Moreover, we expect that there will continue to be federal and state laws and regulations, proposed and implemented,

that could impact our future operations and business.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is

possible that some of our business activities could be subject to challenge under one or more of such laws. Ensuring that

our internal operations and future business arrangements with third parties comply with applicable healthcare laws and

regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business

practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable

fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of the laws

described above or any other governmental laws and regulations that may apply to us, we may be subject to significant

penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, the exclusion from

participation in federal and state healthcare programs, individual imprisonment, reputational harm, and the curtailment or

restructuring of our operations, as well as additional reporting obligations and oversight if we become subject to a

corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Further,

defending against any such actions can be costly and time-consuming, and may require significant financial and

personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought

against us, our business may be impaired. If any of the physicians or other providers or entities with whom we expect to

do business are found to not be in compliance with applicable laws, they may be subject to criminal, civil or

administrative sanctions, including exclusions from government funded healthcare programs and imprisonment. If any of

the above occur, our ability to operate our business and our results of operations could be adversely affected.

Healthcare Reform

In the U.S., the EU and other foreign jurisdictions, there have been a number of legislative and regulatory changes to the

healthcare systems that could affect our future results of operations. In particular, there have been and continue to be a

number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs and improve the quality of

healthcare. For example, the ACA, effective since March 2010, is a sweeping law intended to broaden access to health

insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new

transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on the health

industry and impose additional health policy reforms.

Healthcare reforms that have been adopted, and that may be adopted in the future, could result in further reductions in

coverage and levels of reimbursement for pharmaceutical products, increases in rebates payable under U.S. government

rebate programs and additional downward pressure on pharmaceutical product prices. As discussed above, in August

2022, the IRA was enacted codifying, among other things: a Medicare drug price negotiation program, under which HHS

directly negotiates the selling price of statutorily specified number of Part B and Part D drugs and biologics each year;

inflation rebates which penalizes drug manufacturers that increase prices of Medicare Part B and Part D drugs at a rate

greater than the rate of inflation; and a redesign of the Part D benefit. The IRA permits the Secretary of HHS to

implement many of these provisions through guidance, as opposed to regulation, for the initial years. Manufacturers that

fail to comply with the IRA may be subject to various penalties, including civil monetary penalties. The IRA also

extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan

year 2025. These provisions will take began taking progressively starting in 2023, although certain policies have been

subject to legal challenges. For example, the provisions related to the negotiation of selling prices of high-expenditure

single-source drugs and biologics have been challenged in multiple lawsuits. Additionally, we cannot predict whether the

U.S. Congress will amend the IRA or if the government will adopt new or different interpretations of the law in future

guidance or rulemaking. However, at this time, the Trump administration is continuing to implement the IRA and to

defend the law in litigation. While it is unclear how the IRA will be implemented in the future and the outcome of the

litigation, it will likely have a significant impact on the pharmaceutical industry.


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We expect that additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit

the amounts that the U.S. federal government will pay for healthcare products and services, which could result in

reduced demand for our product candidates or additional pricing pressures.

Further, legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and

promotional activities for pharmaceutical products. We cannot be sure whether additional legislative changes will be

enacted, or whether FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on

the marketing approvals, if any, of our product candidates, may be. In addition, increased scrutiny by the U.S. Congress

of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more

stringent product labeling and post-marketing conditions and other requirements.

Individual states in the U.S. have also become increasingly aggressive in passing legislation and implementing

regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement

constraints, affordability review boards, discounts, restrictions on certain product access and marketing cost disclosure

and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk

purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm

our business, results of operations, financial condition and prospects. In addition, regional healthcare authorities and

individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which

suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate

demand for our products or put pressure on our product pricing, which could negatively affect our business, results of

operations, financial condition and prospects.

In the EU, similar political, economic and regulatory developments may affect our ability to profitably commercialize

our current or any future products. In addition to continuing pressure on prices and cost containment measures,

legislative developments at the EU (such as the above-mentioned EU Pharmaceutical Legislation) or EU Member State

level may result in significant additional requirements or obstacles that may increase our operating costs. In general the

healthcare budgetary constraints in most EU Member States have resulted in restrictions on the pricing and

reimbursement of medicines by relevant health service providers. Coupled with ever-increasing EU and national

regulatory burdens on those wishing to develop and market products, this could prevent or delay marketing approval of

our product candidates, restrict or regulate post-approval activities and affect our ability to commercialize any products

for which we obtain marketing approval.

In international markets, reimbursement and healthcare payment systems vary significantly by country, and many

countries have instituted price ceilings on specific products and therapies.

We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or

administrative action, either in the U.S. or abroad. If we or our collaborators are slow or unable to adapt to changes in

existing requirements or the adoption of new requirements or policies, or if we or our collaborators are not able to

maintain regulatory compliance, our product candidates may lose any regulatory approval that may have been obtained

and we may not sustain or achieve profitability in the future, which would adversely affect our business.

Environmental Issues which may Influence the Use of our Material Fixed Assets

Our primary research and development activities take place in our facilities in Zwijnaarde, Belgium. For these activities

we require, and have obtained, the necessary environmental and biohazard permits from the responsible governments,

required by us for the manner in which we use said facilities.

New shares created during 2024

As a result of the exercise of stock options and vesting of RSUs under our Equity Incentive Plan, 1,566,469 new shares

were created in 2024. Equity Incentive Plan means the equity incentive plan as adopted by our Board of Directors on

December 18, 2014, which was approved by the General Meeting on May 13, 2015, and amended by the General

Meeting on April 28, 2016, and November 25, 2019, and the Board of Directors on December 18, 2019, November 5,

2020, December 15, 2021 and on February 27, 2023 and on February 28, 2024.

The following table shows the developments in our share capital for the year ended December 31, 2024 and on February

19, 2025:


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Number of shares outstanding on December 31, 2022		55,395,856
Number of shares outstanding on December 31, 2023		59,194,488
Exercise of stock options		1,478,225
Vesting of RSUs		88,244
Number of shares outstanding on December 31, 2024		60,760,957
Exercise of stock options in January 2025		223,971
Exercise of stock options in February 2025		5,929
Number of shares outstanding on February 19, 2025		60,990,857

C. ORGANIZATIONAL STRUCTURE

As of December 31, 2024, argenx SE has one subsidiary, argenx BV, which is based in Belgium, and argenx BV has

thirteen subsidiaries. The following table sets out the following information for each of our principal subsidiaries: the

country of incorporation, and percentage ownership and voting interest held by us (directly or indirectly through

subsidiaries).


	As per December 31, 2024
Name	Country	Participation
argenx SE	The Netherlands	100%
argenx B.V.	Belgium	100%
argenx Benelux B.V.	Belgium	100%
argenx US, Inc.	USA	100%
argenx Switzerland, S.A.	Switzerland	100%
argenx Japan KK.	Japan	100%
argenx France SAS	France	100%
argenx Germany GmbH	Germany	100%
argenx Canada Inc.	Canada	100%
argenx UK Ltd.	United Kingdom	100%
argenx Netherlands Services B.V.	The Netherlands	100%
argenx Italy S.r.l.	Italy	100%
argenx Spain S.L.	Spain	100%
argenx Austria Services GmbH	Austria	100%
argenx Australia Pty. Ltd.	Australia	100%

The following chart provides an overview of the Group as of the date of this Annual Report. Percentages refer to both

the share of capital and voting rights.


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D. PROPERTY, PLANTS AND EQUIPMENT

Our principal executive, operational offices and laboratory space located in Zwijnaarde, Belgium. In 2024, we added

new office space in Zwijnaarde. The total future cash flows related to these leases are represented below in

“Note 21 — Leases” in our consolidated financial statements which are appended to our Annual Report for the period

ended December 31, 2024 and which are incorporated herein by reference.

We also lease office space in Amsterdam (the Netherlands), Boston (U.S.), Tokyo (Japan), Geneva (Switzerland),

Munich (Germany), Issy-Les-Moulineaux (France), Vaughan, Ontario (Canada), Gerrards Cross (UK) and Milan (Italy).

In addition, our lease liabilities include a lease plan for company cars with maturity dates up to four years.

For a discussion of contractual obligations, please see “Note 28 — Commitments” in our consolidated financial

statements which are appended to our Annual Report for the period ended December 31, 2024 and which are

incorporated herein by reference.

We have our principal executive, operational offices and laboratory space located in Zwijnaarde, Belgium. The

following table sets forth our key leased facilities worldwide as of December 31, 2024:


Facility location	Use	Approx. size (m2)	Lease expiry
Zwijnaarde, Belgium (leased)	Operations and Laboratory Space	4,951	September 30, 2031
Zwijnaarde, Belgium (leased)	Office Space	3,765	March 31, 2037
Boston, Massachusetts (leased)	Office Space	2,379	August 31, 2030
Tokyo, Japan (leased)	Office Space	546	January 17, 2027

Environment, Health and Safety

Our primary research and development activities take place in our facilities in Zwijnaarde, Belgium. For these activities

we require, and have obtained, the necessary environmental and biohazard permits from the responsible governments,

required by us for the manner in which we use said facilities. See “Item 3.D. — Risk Factors”.

ITEM 4A. UNRESOLVED STAFF COMMENTS

Not applicable.


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ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS

The following “Operating and Financial Review and Prospects” should be read together with the information in our

financial statements and related notes included elsewhere in this Annual Report. The following discussion is based on

our financial information prepared in accordance with the IFRS Accounting Standards (IFRS) as issued by the

International Accounting Standards Board (IASB), which may differ in material respects from generally accepted

accounting principles in other jurisdictions, including U.S. GAAP. The following discussion includes forward-looking

statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those

anticipated in these forward-looking statements as a result of many factors, including but not limited to those described

in “Item 3.D. — Risk Factors” and elsewhere in this Annual Report. Please also see “Cautionary Statement Regarding

Forward-Looking Statements in this Annual Report.

A. OPERATING RESULTS

The review of the financial condition and results of operations of certain items from the year ended December 31, 2022,

and year-to-year comparisons between the years ended December 31, 2023 and December 31, 2022 that are not included

in this Annual Report can be found in “Item 5 — Operating and Financial Review and Prospects” of our annual report

on Form 20-F for the year ended December 31, 2023.

Overview

Since our inception in 2008, we have focused most of our financial resources and efforts towards developing our

SIMPLE ANTIBODY™ Platform and antibody engineering technologies, identifying potential product candidates,

establishing process, development and manufacturing capabilities for our product candidates and advancing multiple

discovery programs into the clinic. In 2022, we executed on our global launch of VYVGART our first-in-class neonatal

FcRn blocker for intravenous use, which is now approved in the U.S., Japan, the EU, Canada, China and other EMEA

jurisdictions for gMG.

In 2023, we launched VYVGART SC, the first-and-only neonatal FcRn blocker administered by subcutaneous injection.

As of the year ended December 31, 2024, it is now approved in the U.S., Japan, the EU, Canada, China and other EMEA

jurisdictions for gMG.

In 2024, we successfully started the sale of VYVGART SC for the treatment of CIDP in the U.S. and obtained approval

in China and Japan. The commercialization of VYVGART IV and VYVGART SC generated global product net sales of

$2.2 billion in 2024 as compared to $1.2 billion in 2023.

On our research and development, we continue towards advancing a deep pipeline of both clinical and preclinical-stage

product candidates for the treatment of severe autoimmune diseases. Leveraging our technology suite and clinical

expertise, we have advanced several candidates into late-stage clinical development and we currently have multiple

programs in the discovery stage.

As of December 31, 2024 and December 31, 2023, we had cash and cash equivalents amounting to $1.5 billion and $2.0

billion, respectively; in addition to current financial assets of $1.9 billion and $1.1 billion, respectively.

Our Statement of Financial Position shows total assets of $6.2 billion for the year ended December 31, 2024, compared

to $4.5 billion for the year ended December 31, 2023. The main reason for the material change in balance sheet total is

the operational growth of the Company in the period.

Since our inception, we have incurred significant operating losses. For the year ended December 31, 2024 the Company

recorded its first annual profit for the year of $833 million. In 2023, the Company recorded a loss for the year of

$295 million. As of December 31, 2024, we had accumulated losses of $1.6 billion.

VYVGART and VYVGART SC are the only approved products we currently have.

We expect our expenses to continue to increase as we continue to execute registrational and proof-of-concept studies

across efgartigimod, empasiprubart and ARGX-119, as well as the continued investment in our IIP. We anticipate that

our expenses will increase if and as we execute on the following elements.

Research and development activities:

•Execute the registrational study of efgartigimod in three myositis subsets (IMNM, ASyS, and DM);

•Execute the Phase 3 clinical studies of efgartigimod in pediatric, seronegative and ocular MG;


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•Execute the Phase 4 study switching CIDP patients from IVIg to VYVGART SC;

•Execute the confirmatory study of efgartigimod in primary ITP;

•Execute the registrational studies of efgartigimod in TED;

•Execute the registrational study of efgartigimod in SjD;

•Execute the Phase 2 study of efgartigimod in LN with our partner Zai Lab;

•Execute the Phase 2 studies of efgartigimod in AMR, SSc and AIE;

•Execute the Phase 3 studies of empasiprubart in MMN and CIDP;

•Execute the Phase 2 studies of empasiprubart in DGF and DM;

•Execute the Phase 1b/Phase 2a studies of ARGX-119 in CMS and ALS, respectively;

•Execute on the launch of Phase 2 study of ARGX-119 in SMA;

•Continue the research and development of our other clinical and preclinical-stage product candidates and discovery

stage programs; and

•Seek regulatory approvals for any product candidates, including new indications, that successfully complete clinical

trials.

Pre-commercial and commercial activities:

•Continue the build-out of our sales, marketing and distribution infrastructure and scale-up of manufacturing

capabilities for the commercial expansion of VYVGART and VYVGART SC and any other product candidate,

including new indications, for which we may obtain approval; and

•Expand our global reach enabling us to commercialize any product candidates, including new indications, for which

we may obtain regulatory approval.

Other activities:

•Seek to enhance our technology platform and discover and develop additional product candidates;

•Maintain, expand and protect our intellectual property portfolio, including litigation costs associated with defending

against alleged patent infringement claims;

•Add clinical, scientific, operational, financial and management information systems and personnel, including

personnel to support our product development and potential future commercialization efforts; and,

•Experience any delays or encounter any issues, including failed studies, ambiguous clinical trial results, safety issues

or other regulatory challenges.

We expect that the costs of development and commercialization might also increase due to current and future

collaborations with research and development partners as well as commercial partners.

Information pertaining to the year ended December 31, 2023 was included in our annual report on Form 20-F for the

year ended December 31, 2023 under “Item 5 — Operating and Financial Review and Prospects’’ which was filed with

the SEC on March 21, 2024.


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Basis of presentation

Foreign Currency Transactions

Functional and presentation currency

Items included in the consolidated financial statements of each of the entities are valued using the currency of their

economic environment in which the entity operates. The consolidated financial statements are presented in USD ($),

which is the Company’s functional and presentation currency.

Revenue from sale of product

Revenue from the sale of products is recognized at an amount that reflects the consideration that the Company expects to

be entitled to receive in exchange for transferring goods to a customer, at the time when the customer obtains control of

the goods rendered, this means when the customer has the ability to direct the use of the asset. The consideration that is

committed in a contract with a customer can include fixed amounts, variable amounts, or both. The amount of the

consideration may vary due to discounts, rebates, returns, chargebacks or other similar items. Contingent consideration is

included in the transaction price when it is highly probable that the amount of revenue recognized is not subject to future

significant reversals.

Our product net sales mainly consist of sales of VYVGART and VYVGART SC in the U.S., Japan, EMEA and China.

Product net sales are recognized once we satisfy the performance obligation at a point in time under the revenue

recognition criteria in accordance with IFRS 15 Revenue from contracts with customers.

Revenue arising from the commercial sale of VYVGART and VYVGART SC is presented under ‘‘Note 17 — Segment

Reporting’’ in our consolidated financial statements which are appended to our Annual Report for the period ended

December 31, 2024 and which are incorporated herein by reference. In accordance with IFRS 15, such revenue is

recognized when the product is physically transferred, in accordance with the delivery and acceptance terms agreed with

the customer. Payment of the transaction price is payable at the point the customer obtains the legal title to the goods.

Revenue from Collaboration and License Agreements

Revenues to date have consisted principally of milestones, license fees, non-refundable upfront fees and research and

development service fees in connection with collaboration and license agreements.

We recognize revenue when the customer obtains control of promised goods or services, in an amount that reflects the

consideration that we expect to receive in exchange for those goods and services. In order to determine revenue

recognition for agreements that we determine to be in the scope of IFRS 15, we followed the IFRS 15 5-step model. The

Company has only recognized revenue from its collaboration with Zai Lab in the current year.

Under the collaboration agreement, the Company provides clinical and commercial supply to Zai Lab. The Company

concludes to recognize such sales as revenue given that the Company acts as principal in the transaction as the risk

related to inventory is borne by the Company until the inventory is transferred to Zai Lab. The revenue related to clinical

supply is recorded under line item “Collaboration revenue”. The revenue related to commercial supply is recorded under

line item “Product net sales” in the Consolidated Statements of Profit or Loss. The income related to royalties or sales-

based milestones on sales made in China is recorded under line item “Collaboration revenue”.

Research and Development Expenses

Research and development expenses consist principally of:

•external research and development expenses related to (i) chemistry, manufacturing and control costs for our product

candidates, both for preclinical and clinical testing, all of which is conducted by specialized contract manufacturers,

(ii) fees and other costs paid to CROs in connection with preclinical testing and the performance of clinical trials for

our product candidates, (iii) costs associated with regulatory submissions and approvals, QA and pharmacovigilance

and (iv) costs associated with post-approval clinical trials;

•personnel expenses related to compensation of research and development staff and related expenses, including

salaries, benefits and share‑based payment expenses;

•Business Information Systems (BIS) related expenses; and


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•other expenses.

Our research and development expenses may vary substantially from period to period based on the timing of our

research and development activities, including the timing of the initiation of clinical trials, material used in R&D phase

and enrollment of patients in clinical trials. Research and development expenses are expected to increase as we advance

the clinical development of efgartigimod, empasiprubart ARGX-119 and further advance the research and development

of our other early-stage pipeline candidates. The successful development of our product candidates is highly uncertain.

At this time, we cannot reasonably estimate the nature, timing and estimated costs of the efforts that will be necessary to

complete the development of, or the period, if any, in which material net cash inflows may commence from any of our

product candidates. This is due to numerous risks and uncertainties associated with developing drugs, as further

described in “Item 3.D. — Risk Factors”.

Selling, General and Administrative Expenses

Selling, general and administrative expenses consist primarily of:

•personnel expenses related to compensation of commercial and enabling staff and related expenses, including salaries,

benefits and share‑based payment expenses;

•professional fees related to commercial and enabling functions;

•Board of Directors expenses consisting of directors’ fees, travel expenses and share-based compensation for non-

executive board members;

•marketing and promotional activities related to the global commercialization of VYVGART and VYVGART SC for

the treatment of gMG, CIDP and ITP (in Japan); and

•other Selling, general and administrative expenses, including leasing costs, office expenses and travel costs.

We expect our general and administrative expenses to increase as we continue to support our growth. Such costs include

increases in our personnel, additional BIS-related expenses, and expenses and costs associated with compliance with the

regulations governing public companies. We expect our selling and marketing expenses to increase due to marketing and

promotional activities with respect to the ongoing commercial launch of VYVGART, VYVGART SC and preparation of

commercial launch of our other product candidates.

Financial Income (Expense)

Financial income mainly reflects interest earned on our cash and cash equivalents and current financial assets and net

gains on our cash and cash equivalents and current financial assets held at fair value through profit or loss. Financial

expense corresponds mainly to interest expenses arising from lease liabilities.

Exchange Gains (Losses)

Our exchange gains (losses) relate to (i) our transactions denominated in foreign currencies, mainly in euro, and which

generate exchange gains or losses and (ii) the translation at the reporting date of assets and liabilities denominated in

foreign currencies into USD, which is our functional and presentation currency. For more information on currency

exchange fluctuations on our business, please see “Note 25 — Financial Risk Management — Foreign exchange risk’’ in

our consolidated financial statements which are appended to our Annual Report for the period ended December 31,

2024. We have no derivative financial instruments to hedge interest rate and foreign currency risk.

Income Tax Benefit (Expense)

For the year ended December 31, 2024 the Company recognized its Belgian based deferred tax assets. For more

information on income taxes and deferred taxes, please see “Note 23 — Income taxes” in our consolidated financial

statements which are appended to our Annual Report for the period ended December 31, 2024 and which are

incorporated herein by reference.


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Results of Operations

Comparison of Years Ended December 31, 2024 and 2023


	Year Ended December 31,
(in thousands of $ except for shares and EPS)	2024		2023		% Change
Product net sales	$	2,185,883	$	1,190,783	84%
Collaboration revenue		4,348		35,533	(88)%
Other operating income		61,808		42,278	46%
Total operating income		2,252,039		1,268,594	78%
Cost of sales		(227,289)		(117,835)	93%
Research and development expenses		(983,423)		(859,492)	14%
Selling, general and administrative expenses		(1,055,337)		(711,905)	48%
Loss from investment in a joint venture		(7,644)		(4,411)	73%
Total operating expenses		(2,273,693)		(1,693,643)	34%
Operating loss		(21,654)		(425,049)	(95)%
Financial income		157,509		107,386	47%
Financial expense		(2,464)		(906)	172%
Exchange (losses)/gains		(48,211)		14,073	(443)%
Profit/(Loss) for the year before taxes	$	85,180	$	(304,496)	128%
Income tax benefit		747,860		9,443	7819%
Profit/(Loss) for the year	$	833,040	$	(295,053)	382%
Weighted average number of shares outstanding		59,855,585		57,169,253
Weighted average number of shares for purpose of diluted profit/ (loss) per share		65,177,815		57,169,253
Basic profit/(loss) per share (in $)		13.92		(5.16)
Diluted profit/(loss) per share (in $)		12.78		(5.16)

Product net sales


	Year Ended December 31,
(in thousands of $)	2024		2023
United States	$	1,895,919	$	1,046,592
Japan		89,389		56,432
China		39,177		14,907
Rest of the World		161,398		72,852
Total product net sales	$	2,185,883	$	1,190,783

Our product net sales have increased in the U.S. and other countries as the Company continues to execute on the global

commercialization of VYVGART and VYVGART SC and obtain further approvals worldwide.


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Collaboration Revenue


	Year Ended December 31,
(in thousands of $)	2024		2023		% Change
AbbVie	$	—	$	30,000	(100)%
Zai Lab		4,348		5,533	(21)%
Total collaboration revenue	$	4,348	$	35,533	(88)%

Our collaboration revenue decreased by $31 million to $4 million for the year ended December 31, 2024, compared to

$36 million for the year ended December 31, 2023. The collaboration revenue recognized in the year ended

December 31, 2024 was mainly the result of the clinical supply of product and royalties on product net sales of

VYVGART in Greater China through Zai Lab.

Other Operating Income


	Year Ended December 31,
(in thousands of $)	2024		2023		% Change
Research and development incentives	$	46,106	$	27,815	66%
Payroll tax rebates		11,855		11,925	(1)%
Grants		13		2,538	(99)%
Change in fair value on non-current financial assets		3,834		—	100%
Total other operating income	$	61,808	$	42,278	46%

Other operating income increased by $20 million to $62 million for the year ended December 31, 2024, compared to

$42 million for the year ended December 31, 2023. The $20 million increase was primarily driven by:

•the increase in research and development incentives due to a Belgian research and development tax incentive scheme,

as a result of the overall increased research and development costs incurred;

•the increase in payroll tax rebates for the year ended December 31, 2024, as a result of higher research and

development personnel expenses eligible for rebates for the year ended December 31, 2024

•an increase of $4 million due to the change in fair value on our profit share in AgomAb for the year ended

December 31, 2024.

For more information regarding governmental policies that could affect our operations, see “Item 4.B. — Business

Overview” and “Healthcare Law and Regulation”.


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Research and Development Expenses


	Year Ended December 31,
(in thousands of $)	2024		2023		% Change
External research and development expenses	$	605,082	$	483,192	25%
Personnel expenses		310,992		226,344	37%
BIS expenses		34,012		19,935	71%
Materials and consumables		5,863		4,057	45%
Depreciation and amortization		6,204		105,546	(94)%
Other expenses		21,270		20,418	4%
Total Research and development expenses	$	983,423	$	859,492	14%

Our research and development expenses totaled $983 million and $859 million for the years ended December 31, 2024

and 2023, respectively. The increase of$124 million in 2024 as compared to 2023 is primarily driven by Personnel

expenses and External research and development expenses. This is offset by the decrease in Depreciation and

amortization resulting from the use of a Priority Review Voucher (PRV) for priority review by the FDA of its

VYVGART HYTRULO for use in CIDP in 2023.

Personnel expenses relate to internal and external R&D personnel. The expenses also include share-based compensation

expenses related to the grant of stock options and RSUs to our research and development employees. We employed on

average 805 full-time equivalents in our research and development functions in the year ended December 31, 2024,

compared to 607 in the year ended December 31, 2023.

Our external research and development expenses for the year ended December 31, 2024 totaled to $605 million,

compared to $483 million for the year ended December 31, 2023. The expenses reflect clinical trial costs and

manufacturing expenses related to the development of our product candidate portfolio. The table below provides

additional detail on our external research and development expenses by program:


		Year Ended December 31,
(in thousands of $)	2024		2023		% Change
efgartigimod	$	405,347	$	361,676	12%
empasiprubart		86,254		47,636	81%
ARGX-119		26,098		13,731	90%
cusatuzumab		10,856		14,298	(24)%
Other programs		76,527		45,851	67%
Total	$	605,082	$	483,192	25%

External research and development expenses for our lead product efgartigimod totaled $405 million for the year ended

December 31, 2024, compared to $362 million for the year ended December 31, 2023 relating to the efforts in evaluating

in more than 15 severe autoimmune diseases including MG, CIDP and ITP.

External research and development expenses for empasiprubart totaled $86 million for the year ended December 31,

2024 compared to $48 million for the year ended December 31, 2023. This increase of $39 million was due to the ramp-

up of Phase 2 clinical trials in MMN, DGF, DM and CIDP.

External research and development expenses for ARGX-119 increased by $12 million to $26 million for the year ended

December 31, 2024 as we continue to invest in proof-of-concept studies ongoing in ALS and CMS.

Our investments in other programs have increased by $31 million with four new pipeline candidate nominations to IIP

alongside our continued Discovery programs.


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Selling, general and administrative Expenses


	Year Ended December 31,
(in thousands of $)	2024		2023		% Change
Personnel expenses	$	424,916	$	303,033	40%
Marketing services		306,987		202,146	52%
Professional fees		170,215		108,820	56%
BIS expenses		27,295		20,408	34%
Facilities and occupancy expenses		20,888		11,264	85%
Supervisory board		9,724		8,362	16%
Depreciation and amortization		3,149		2,366	33%
Other expenses		92,163		55,506	66%
Total Selling, general and administrative expenses	$	1,055,337	$	711,905	48%

The increase in our Selling, general and administrative expenses for the year ended December 31, 2024 was principally

resulting from:

•increased professional and marketing fees, including promotional and marketing costs primarily due to the scaling of

our commercial operations relating to VYVGART and VYVGART SC;

•increased costs of personnel expenses is related to planned increase in the headcount of our Selling, general and

administrative employees recruited to strengthen our enabling functions and the scaling of our commercial operations

relating to VYVGART and VYVGART SC; and

•continued investment in our IT infrastructure.

We employed on average 835 full-time equivalents in our selling, general and administrative functions in the year ended

December 31, 2024, compared to 681 in the year ended December 31, 2023.

Financial Income and (Expense)

For the year ended December 31, 2024, financial income amounted to $158 million compared to $107 million for the

year ended December 31, 2023. The increase of $50 million in 2024 related primarily to the capital increase of our

financial assets.

Exchange Gains (Losses)

Exchange losses totaled $48 million for the year ended December 31, 2024, compared to exchange gains of $14 million

for the year ended December 31, 2023. The losses were mainly attributable to unrealized exchange rate losses on the

cash and cash equivalents, in addition to current financial assets position in euro during the year ended December 31,

2024.

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B. LIQUIDITY AND CAPITAL RESOURCES

Sources of Funds

The table below sets forth our capitalization as of December 31, 2024 on an actual basis based on the information

available in our Consolidated Financial Statements:


(in thousands of $)		As of December 31, 2024
Shareholder equity	$	5,498,283
Share capital		7,227
Share premium		5,948,916
Legal reserve(s) 1)		126,832
Retained earnings		(1,571,804)
Other reserves		987,112
Total	$	5,498,283

1)Legal reserves are the amount of translation differences.

Since our inception in 2008, we have invested most of our resources in developing our product candidates, building our

intellectual property portfolio, developing our supply chain, conducting business planning, raising capital and providing

general and administrative support for these operations. December 31, 2023To date, we have funded our operations

through public and private placements of equity securities, upfront, milestone and expense reimbursement payments

received from our collaborators, funding from governmental bodies, proceeds from exercise of employee stock options

and interest income from the investment of our cash and cash equivalents, in addition to current financial assets. Through

December 31, 2024, we have raised gross proceeds of $5.9 billion from private and public offerings of equity securities.

We currently have two products approved by the FDA, VYVGART and VYVGART SC; therefore, our commercial

operations have also started to contribute to the funding of our operations. We have made product net sales of

$2.2 billion during the twelve months ended December 31, 2024.

As we continue to invest in innovation and the our cash flows may fluctuate, are difficult to forecast and will depend on

many factors.

We have no ongoing material financing commitments, such as lines of credit or guarantees, that are expected to affect

our liquidity over the next five years, other than leases and commitments as part of our operations, which are detailed in

“Note 28 — Commitments” in our consolidated financial statements which are appended to our Annual Report for the

period ended December 31, 2024 and which are incorporated herein by reference.

For more information as to the risks associated with our future funding needs, see “Item 3.D. — Risk Factors — Risk

For more information as to our financial instruments, please see “Note 25 — Financial Risk Management” in our

consolidated financial statements which are appended to our Annual Report for the period ended December 31, 2024

and which are incorporated herein by reference.

Table of Contents

Cash Flows

Comparison for the Years Ended December 31, 2024 and 2023

The table below summarizes our cash flows for the years ended December 31, 2024 and 2023.


		Year Ended December 31,
(in thousands of $)	2024		2023			Variance
Cash and cash equivalents at the beginning of the year	$	2,048,844	$	800,740	$	1,248,104
Net cash flows used in operating activities		(82,747)		(420,327)		337,580
Net cash flows from/(used in) investing activities		(717,594)		308,210		(1,025,804)
Net cash flows from financing activities		279,759		1,336,727		(1,056,968)
Exchange gains/(losses) on cash and cash equivalents		(28,326)		23,494		(51,820)
Cash and cash equivalents at the end of the year	$	1,499,936	$	2,048,844	$	(548,908)

As of December 31, 2024, the Company had $1.5 billion of cash and cash equivalents compared to $2.0 billion as of

December 31, 2023. For more information, please see “Note 11 — Cash and Cash Equivalents” in our consolidated

financial statements which are appended to our Annual Report for the period ended December 31, 2024 and which are

incorporated herein by reference.

Net Cash Used in Operating Activities

Net cash outflow used in our operating activities decreased by $338 million to a net outflow of $83 million for the year

ended December 31, 2024, compared to a net outflow of $420 million for the year ended December 31, 2023.

The decrease in net cash used in operating activities results primarily from an increase in product net sales of

VYVGART and VYVGART SC, partly offset by:

(i)the increase in research and development expenses incurred in relation to the manufacturing and clinical

development activities of efgartigimod and the advancement of other clinical, preclinical and discovery-stage

product candidates;

(ii)the increase in personnel expenses, marketing expenses and consulting expenses incurred for the commercial

growth of VYVGART and VYVGART SC; and

(iii)the further increase in working capital as a result of our inventory levels, including prepaid inventory

Net Cash Used in/from Investing Activities

Investing activities for the year ended December 31, 2024, consist primarily of the net movements in current financial

assets of $754 million, and interests received, partly offset by payments related to regulatory and sales based milestones

to Halozyme and investment in OncoVerity, resulting in a cash outflow of $718 million.

Investing activities for the year ended December 31, 2023, consist primarily of net movements in current financial assets

of $272 million, and purchase of a priority review voucher for $102 million, partly offset by payments related to

regulatory and sales based milestones to Halozyme and investment in OncoVerity, resulting in a cash inflow of

$308 million.

Net Cash Provided by Financing Activities

The net cash inflow from financing activities was $280 million for the year ended December 31, 2024, compared to a net

cash inflow of $1.3 billion for the year ended December 31, 2023. The net cash inflows were mainly attributed to

proceeds received from the exercise of stock options in 2024 as compared to inflows from issuance of new shares in

2023.


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Operating and Capital Expenditure Requirements

We have achieved after-tax profitability as of December 31, 2024, mainly resulting from the recognition of deferred tax

assets held by argenx BV, a subsidiary of the Company. As of the year ended December 31, 2024, we had accumulated

losses of $1.6 billion. Our losses resulted principally from costs incurred in research and development, preclinical testing

and clinical development of our research programs, and from selling, general and administrative costs associated with

commercial expansion.

We anticipate that our operating expenses will increase as we intend to continue to conduct research and development

and continue our efforts to expand our sales, marketing and distribution infrastructure. Although we have generated

product net sales of $2.2 billion from global product net sales of VYVGART and VYVGART SC for the treatment of

gMG and CIDP for the year ended December 31, 2024, which supports our current profitability, we can provide no

assurances that we will be able to be profitable or sustain net profitability in the future based on these indications alone

or that we will be able to receive regulatory approval of and commercialize VYVGART and VYVGART SC in other

indications or in other countries.

On the basis of current assumptions, we expect that our existing cash and cash equivalents and current financial assets

will enable us to fund our operating expenses and capital expenditure requirements through at least the next twelve

months. Due to the numerous risks and uncertainties associated with the development and commercialization of

efgartigimod and our other product candidates and discovery stage programs and because the extent to which we may

enter into collaborations with third parties for the development of these product candidates is unknown, we are unable to

estimate the amounts of increased capital outlays and operating expenses associated with completing the research and

development of our product candidates. Our future capital requirements for efgartigimod and our other product

candidates and discovery stage programs will depend on many factors, including:

•the progress, timing and completion of preclinical testing and clinical trials for our current or any future product

candidates;

•the number of potential new product candidates we identify and decide to develop;

•the time and costs involved in obtaining regulatory approval for our product candidates and any delays we may

encounter as a result of evolving regulatory requirements or adverse results with respect to any of our product

candidates;

•selling and marketing activities undertaken in connection with the commercialization of VYVGART, VYVGART SC

or potential commercialization of any of our current or any future product candidates, if approved, and costs involved

in the creation of an effective sales and marketing organization;

•manufacturing activities undertaken for VYVGART, VYVGART SC and potential commercialization of any of our

current or any future product candidates, if approved, and costs involved in the creation of an effective supply chain;

•the costs involved in growing our organization to the size needed to allow for the research, development and potential

commercialization of our current or any future product candidates;

•the costs involved in filing patent applications and maintaining and enforcing patents or defending against claims or

infringements raised by third parties;

•the maintenance of our existing collaboration agreements and entry into new collaboration agreements; and

•developments related to the global economic uncertainties and political instability.

For more information as to the risks associated with our future funding needs, see “Item 3.D. — Risk Factors — Risk

Factors — Risk Factors Related to argenx’s Financial Position and Need for Additional Capital".

Cash Investment Policy

The Company has adopted a policy whereby cash and cash equivalents and current financial assets are invested with

several highly reputable banks and financial institutions. The main purpose of the Cash Investment Policy is to preserve


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the available cash and to ensure sufficient short-term liquidity at all times. Therefore, the Company holds its cash, cash

equivalents and current financial assets mainly with banks which are independently rated A- or higher. Amounts of cash

held with banks rated lower than A- are limited to insignificant balances. The maximum amount and tenor of time

deposits depends on the rating of the counterparty bank. The Company also holds cash equivalents in the form of money

market funds with a low historical volatility. These money market funds are highly liquid investments and can be readily

convertible into a known amount of cash. The Company has adopted a policy whereby money market funds must have a

minimum rating of A of which 95% should have a AAA-rating.

For more information as to our treasury policy and liquidity, please see “Note 25 — Financial Risk Management” in our

consolidated financial statements which are appended to our Annual Report for the period ended December 31, 2024

and which are incorporated herein by reference.

Working capital statement

As of December 31, 2024, the Company had $1.5 billion of cash and cash equivalents and $1.9 billion of current

financial assets, while the shareholder equity amounted to $5.5 billion and the non-current and current Lease liabilities to

$33 million and $7 million, respectively.

In accordance with item 3.1 of Annex 11 of the Commission Delegated Regulation (EU) 2019/980 we make the

following statement:

In our opinion, the working capital of the Company is sufficient for the Company’s present requirements, at least for a

period of 12 months from the date of this Annual Report.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off‑balance sheet arrangements, as

defined in the applicable rules and regulations, such as relationships with unconsolidated entities or financial

partnerships, which are often referred to as structured finance or special purpose entities, established for the purpose of

facilitating financing transactions that are not required to be reflected on our balance sheets.

C. RESEARCH AND DEVELOPMENT, PATENTS AND LICENSES

For a discussion of our research and development policies, see the “Item 4 — Information on the Company” and “Item

5 — Operating and Financial Review and Prospects” within Section 5.

D. TREND INFORMATION

Other than as disclosed elsewhere in this Annual Report, we are not aware of any trends, uncertainties, demands,

commitments or events for the current financial period that are reasonably likely to have a material effect on our net

revenues, income, profitability, liquidity, capital resources or prospects, or that caused the disclosed financial

information to be not necessarily indicative of future operating results or financial conditions.

There has been no significant change in the financial performance or the financial position of the Group since the

balance sheet date of December 31, 2024.

For more information, please refer to “Item 4.B — Business Overview”, “Item 5.A. — Operating Results”, “Item 5.B. —

Liquidity and Capital Resources” and “Note 28 — Commitments’’ in our consolidated financial statements which are

appended to our Annual Report for the period ended December 31, 2024 and which are incorporated herein by reference.

E. CRITICAL ACCOUNTING ESTIMATES

See “Note 3 — Critical accounting judgments and major sources of estimation uncertainty’’ in our consolidated

financial statements which are appended to our Annual Report for the period ended December 31, 2024 and which are

incorporated herein by reference.

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ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES

A. DIRECTORS AND SENIOR MANAGEMENT

Our Board of Directors

As at December 31, 2024, we have a one-tier board structure consisting of 1 Executive Director and 9 Non-Executive

Directors, and a Senior Management Team responsible for the day-to-day operations.

Our Board of Directors had 5 formal meetings in the course of 2024.The meetings were held in the months February,

May, July, October and December. The committees of the Board of Directors also convened regularly and at least once

per quarter.. (Refer to “Item 6.C. — Board Practices — Report Audit and Compliance Committee”, Item 6.C. — Board

Practices — Report Audit and Compliance Committee”, “Item 6.C. — Board Practices — Report Audit and Compliance

Committee”, and “Item 6.C. — Board Practices—Report Audit and Compliance Committee”)” below for the separate

reports of the committees.

All Board of Director meetings and 16 out of 19 formal committee meetings were also attended by Mr. Van

Hauwermeiren, as executive director. In addition, several members of the Senior Management Team were invited to

discuss specific items included on the Board of Director and committee meetings’ agendas (please refer to “Item 6.A. —

Directors and Senior Management — Attendance Record Board of Director Meetings”).

Set out below is a summary of certain provisions of Dutch corporate law as of the date of this Annual Report, as well as

a summary of relevant information concerning our Board of Directors and certain provisions of our Articles of

Association and the Board By-Laws.

This summary does not purport to give a complete overview and should be read in conjunction with and is qualified in

its entirety by reference to the relevant provisions of Dutch law as in force on the date of this Annual Report, the Articles

of Association and Board By-Laws. The Articles of Association are available in the governing Dutch language and an

unofficial English translation thereof, and the Board By-Laws are available in English, on our website.

The following table sets forth certain information with respect to the current members of our Board of Directors,

including their ages as of December 31, 2024:

Name

Age

Position

Nationality

Date of Initial

Appointment

Date of last (re-)

Appointment

Term

expiration

Tim Van Hauwermeiren

CEO and

executive

director

Belgium

July 15, 2008

May 10, 2022

2026

Mr. Peter Verhaeghe

Non-Executive

Director

(chairperson)

Belgium

October 15, 2008

May 7, 2024

2026

Mr. Steve Krognes

Non-Executive

Director

U.S. and Norway

February 27,

2023

February 27, 2023

2027

Dr. Donald deBethizy

Non-Executive

Director (vice-

chairperson)

U.S.

May 13, 2015

May 2, 2023

2025 1)

Dr. Pamela Klein

Non-Executive

Director

U.S.

April 28, 2016

May 7, 2024

2026

Anthony Rosenberg

Non-Executive

Director

April 26, 2017

May 11, 2021

2025

James Daly

Non-Executive

Director

U.S.

May 8, 2018

May 10, 2022

2026

Camilla Sylvest

Non-executive

director

Denmark

September 8,

2022

September 8, 2022

2026

Dr. Ana Cespedes

Non-executive

director

Spain

December 12,

2022

December 12, 2022

2026

Dr. Brian Kotzin

Non-Executive

Director

U.S.

May 7, 2024

2028


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1)On February 27, 2025, it was announced that Donald deBethizy will retire from the Board of Directors after the 2025 General Meeting. Anthony Rosenberg will succeed as the vice-chairperson of the

Board of Directors.

Mr. Peter Verhaeghe

Peter Verhaeghe has served as a member and chairperson of the board of arGEN-X B.V. since October 2008 and as Non-

Executive Director on our Board of Directors since July 2014.

Mr. Verhaeghe is the managing partner of VVGB Advocaten-Avocats, a corporate finance law and tax law firm, a

position he has held since July 1999. He is currently lead counsel to a number of Belgian, Dutch, French, U.S. and Swiss

life sciences companies. Mr. Verhaeghe has served on the boards of directors of Participatiemaatschappij Vlaanderen

NV since May 2018 and miDiagnostics NV since April 2020. He has also served as chairman of the board of Haretis SA

(Luxembourg) since March 2011 and as chairman of the LP & advisory committee of Bioqube Factory Fund I NV since

September 2020. Mr. Verhaeghe previously served as a member of the board of directors of CzechPak Manufacturing

s.r.o., Innogenetics NV (now Fujirebio Europe N.V.), Tibotec-Virco NV, and Biocartis SA. He was also the president of

the board of directors of Merisant France SAS, a member of the management board of Merisant Company 2 S.à. rl., and

chairman of the board of directors of PharmaNeuroBoost NV.

Mr. Steve Krognes

Steve Krognes has served as a member of our Board of Directors and as a chairperson of our Audit and Compliance

Committee since February 2023.

Mr. Krognes also serves on the boards of directors of Guardant Health, Inc., Denali Therapeutics, Inc., and Pliant

Therapeutics, Inc. In September 2023, he also was appointed to the board of directors of ClayvstBio. He previously

served on the boards of directors of RLS Global AB and Corvus Pharmaceuticals, Inc. and Gritstone Bio, Inc. Mr.

Krognes was the chief financial officer of Denali Therapeutics, Inc. from 2015 until retiring from that position in April

2022. Mr. Krognes led successful financings for Denali Therapeutics, Inc., including its initial public offering in 2017,

and contributed significantly to the company’s strategy, growth and strong financial position. His extensive leadership

experience in the biotech and pharmaceutical industries includes 12 years in total at Roche and Genentech, Inc., during

which Mr. Krognes served as chief financial officer of Genentech, Inc. for six years and global head of Roche’s mergers

& acquisition team for six years. He also chaired the Genentech Access to Care Foundation and represented Genentech

on the board and executive committee of the California Life Science Association. Before that, Mr. Krognes worked as an

investment banker at Goldman Sachs, as a management consultant at McKinsey & Company, and as a venture capitalist

in Scandinavia.

Dr. Donald deBethizy

Donald deBethizy has served as a member of our Board of Directors since May 2015.

Dr. deBethizy has 30 years of experience in research and development, as well as financial, business and operating

management, and board work in the biotechnology and consumer products industries.

He is the president of White City Consulting ApS, also known as Custom Coaching) a consulting company that

specializes in advising technology-focused companies. Dr. deBethizy currently serves on the boards of directors of

Lophora ApS and Proterris, Inc. and as a board advisor for Cereno Scientific AB.

Previously, Dr. deBethizy served as president and CEO of Santaris Pharma A/S until October 2014, when the company

was sold to Roche. From March 1997 to June 2012, Dr. deBethizy was co-founder and CEO of Targacept, Inc., a U.S.

biotechnology company listed on Nasdaq. From June 2012 to May 2013, he was special advisor to the chairman of

Targacept, Inc.’s board of directors. From May 2013 to November 2014, Dr. deBethizy served as executive chairman of

Contera Pharma ApS until it was sold to Bukwang Pharma, and from July 2015 to November 2017, he served as

chairman of Rigontec GmbH until it was sold to Merck Inc. He previously served as chairman of the boards of directors

of Albumedix Ltd (sold to Sartorius AG in September 2022), Saniona AB, and TME Pharma NV and AG. Dr. deBethizy

was also a member of the boards of directors of Asceneuron SA, Serendex Pharmaceuticals A/S, Enbiotix Inc., Ligocyte

Pharmaceuticals until it was sold to Takeda Pharmaceutical Co Ltd, Biosource Inc., and NOXXON Pharma N.V. Dr.

deBethizy has held adjunct appointments at Wake Forest University Babcock School of Management, Wake Forest

University School of Medicine, and Duke University.

Dr. Pamela Klein

Pamela Klein has served as a member of our Board of Directors since April 2016.


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Since 2008, Dr. Klein has been a principal and founder of PMK BioResearch, a company offering strategic consulting in

oncology drug development to corporate boards, management teams and the investment community. She has also been a

venture partner in Ysios Capital Partners, SGIEC, S.A.U. since 2023. She currently serves as a member of the board of

directors of several companies including Shasqi and Patrys Ltd; as well as various scientific advisor boards. In 2023, Dr.

Klein also joined the boards of directors of Frontier Medicines Corp, Ona Therapeutics SL, and Sardona Therapeutics,

Inc. Previously, Dr. Klein served on the board of directors of Sardona Therapeutics, Inc., F-Star Therapeutics, Inc. until

March 2023, Jiya Acquisition Corp, and Spring Bank Pharmaceuticals, Inc. until its merger with F-Star Therapeutics in

July 2020. Dr. Klein previously spent seven years at the National Cancer Institute as research director of the NCI-Navy

Breast Center, after which she joined Genentech as vice president of development until 2001. She also served as chief

medical officer for Intellikine, Inc., which was acquired by Takeda American Holdings.

Anthony Rosenberg

Anthony Rosenberg has served as a member of our Board of Directors since April 2017.

He currently serves as chief executive officer of TR Advisory Services GmbH, his own consultancy firm advising on

business development, licensing, and mergers and acquisitions. Mr. Rosenberg also currently serves as chairman of the

boards of directors of NUCLIDIUM AG, Oculis SA and Cullinan Therapeutics Inc. Previously Mr. Rosenberg held the

positions of Managing Director at MPM Capital, a venture capital firm (2015 until 2020); head of M&A and Licensing

of Novartis International (2013 to 2015); and head of business development and licensing at Novartis Pharma (2005 to

2012). Mr. Rosenberg also previously served on the boards of directors of SiO2 Material Science (until March 2023),

Radius Health Inc., TriNetX, Inc., iOmx Therapeutics AG, and Clinical Ink, Inc.

James Daly

James Daly has served as a member of our Board of Directors since May 2018. Mr. Daly currently also serves as a

director of Acadia Pharmaceuticals, Inc. and Madrigal Pharmaceuticals, Inc. He was formerly a member of the board of

Halozyme, Bellicum Pharmaceuticals, Inc. and Chimerix, Inc.

In 1985, he joined GlaxoSmithKline where he held various positions, including senior vice president of the respiratory

division with full responsibility for sales, marketing and medical affairs. Mr. Daly moved to Amgen Inc. in 2001 where

he was senior vice president for the North America commercial operations until 2011. In 2012, he joined Incyte Corp, a

publicly-traded company focused on oncology and inflammation, where he was chief commercial officer until June

2015.

Camilla Sylvest

Camilla Sylvest has served as a member of our Board of Directors since September 2022. Ms. Sylvest currently serves as

the executive vice president of commercial strategy and corporate affairs of Novo Nordisk A/S.

Ms. Sylvest has more than 28 years of working experience within Novo Nordisk A/S and was based in Switzerland,

Denmark, Germany, Malaysia, and Mainland China. Over the years, Ms. Sylvest has headed up Novo Nordisk A/S

affiliates of growing size and complexity in Europe. She was also corporate vice president of the business area Oceania

and Southeast Asia and senior vice president and general manager of the Novo Nordisk A/S region of Mainland China.

Ms. Sylvest also serves as a member of the board of Danish Crown A/S.

Dr. Ana Cespedes

Ana Cespedes has served as a member of our Board of Directors since December 2022. Dr. Cespedes is currently the

chief operating officer of the International AIDS Vaccine Initiative, a global organization dedicated to developing

accessible vaccines and antibodies for infectious diseases. She will resign from the International AIDS Vaccine Initiative

as of the end of March 2025 and she will become the chief executive officer of Vitamin Angels at the end of March

2025.

Prior to joining the International AIDS Vaccine Initiative, Dr. Cespedes held several roles at Merck KGaA, most

recently serving as global head of strategy and engagement, government, and public affairs. She founded and led the

global market access and pricing function for the company and worked with stakeholders to communicate the clinical,

economic, and societal value of innovative medicines. Prior to that, Dr. Cespedes led the first integrated corporate affairs

group at Serono Iberia and Merck Spain, was managing director of the Spanish branch of the company’s nonprofit

organization, and worked as a senior consultant at Arthur Andersen. Dr. Cespedes is a founding member of the National

Congress of Corporate Affairs in Spain, the London School of Economics Market Access Academy, and the Cooperation

for Oncology Data. She is also the founder of Living Mindfulness S.L. Dr. Cespedes is also a member of the steering

committee of ProPatiens Institute.


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Dr. Brian Kotzin

Brian Kotzin has served as a member of our Board of Directors and as a chairperson of our research and development

committee since May 7, 2024.

He is a former member of the board of directors at Vera Therapeutics, Inc., Rigel Pharmaceuticals, Inc. and Kyverna

Therapeutics, Inc. He served as Senior Vice President for Nektar Therapeutics, Inc. from April 2017 to June 2023, and

has held various leadership positions at Nektar Therapeutics, Inc., including serving as Chief Medical Officer and Head

of Clinical Development from January 2021 to September 2021 and again from May 2022 to June 2023. He currently is

the interim chief medical officer at Nektar Therapeutics, Inc. From 2004 to 2015, Dr. Kotzin was Vice President, Global

and Clinical Development and Head, Inflammation Therapeutic Area at Amgen Inc., directing the global development

efforts for product candidates in the inflammation area. During his employment at Amgen Inc, he also served as Vice

President of Translational Sciences and Head of Medical Sciences from 2006 to 2011. Prior to entering the life sciences

industry, Dr. Kotzin held several positions as a professor at the University of Colorado Health Sciences Center, where

his research focused on immunopathogenesis of inflammatory diseases. He has also held leadership roles at several

national organizations, including as a member of the American College of Rheumatology (ACR) Board of Directors,

Member and Chairperson of the NIH Immunological Sciences Study Section, Chairperson of the NIH Autoimmunity

Centers of Excellence, and Member of the Board of Directors for the Federation of Clinical Immunology Societies.

Attendance Record Board of Director Meetings

In 2024, 5 Board of Directors meetings were held. The meeting attendance rate for our directors is set out in the table

below.


Name	Number of meetings attended in 2024 since appointment (and up to resignation, as applicable)	Attendance %
Mr. Peter Verhaeghe (chairperson)	5	100%
Tim Van Hauwermeiren	5	100%
Mr. Steve Krognes	5	100%
Dr. Donald deBethizy (vice-chairperson)	5	100%
Dr. Pamela Klein	5	100%
Anthony Rosenberg	5	100%
James Daly	5	100%
Camilla Sylvest	5	100%
Dr. Ana Cespedes	5	100%
Dr. Brian Kotzin 1)	4	100%

1)Dr. Brian Kotzin was appointed to the Board of Directors as of May 7, 2024.

In 2024, all of the 5 Board of Directors meetings with solely the Non-Executive Directors being present were held as

closed sessions at the beginning or the end of other meetings. These meetings were attended by all Non-Executive

Directors appointed at such time.


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Name	Number of meetings attended in 2024 since appointment	Attendance %
Mr. Peter Verhaeghe (chairperson)	5	100%
Dr. Donald deBethizy (vice-chairperson)	5	100%
Dr. Pamela Klein	5	100%
Anthony Rosenberg	5	100%
James Daly	5	100%
Camilla Sylvest	5	100%
Dr. Ana Cespedes	5	100%
Dr. Brian Kotzin 1)	4	100%

1)Dr. Brian Kotzin was appointed to the Board of Directors as of May 7, 2024.

Activities

The agenda for the Board of Directors centers around the key business objectives for long-term value creation and the

key risks involved, as well as the manner in which the Senior Management Team implements our strategy including our

research and development pipeline and the commercialization of our products, our culture to ensure proper monitoring

by the Non-Executive Directors, our financial position as well as the results of our subsidiaries, significant investment

proposals, yearly budgets, the internal risk management and control system, talent development, succession planning and

remuneration and appointment matters.

In 2024, the Board of Directors primarily discussed the Company's innovation mission and objectives and reviewed the

scientific pipeline and regulatory developments for all product candidates, ensuring the required progression thereof. The

Board of Directors furthermore reviewed and discussed the commercialization strategies and opportunities, contributing

to our successful product launches and sales ramp-up. The Board of Directors also spent a significant amount of time on

talent development and succession planning, both for the senior leaders within the Company (within and beyond the

Senior Management Team) and the Board of Directors. This lead to the appointment of Dr. Brian Kotzin as a Non-

Executive Director and chairperson of the research and development committee and the renewal of the appointment of

Dr. Pamela Klein and Mr. Peter Verhaeghe as Non-Executive Directors and Mr. Peter Verhaeghe's reappointment as

chairperson of the Board of Directors. A lot of time was also spent discussing and evaluating the Company's rapid

growth and how to maintain our unique company culture through these periods of growth. Finally, the Board of

Directors spent time discussing our ESG journey and shareholder feedback on say-on-pay and how to address that.

Our Senior Management

The following table sets forth certain information with respect to the members of our Senior Management Team,

including their ages, as of December 31, 2024:


Name	Age	Position	Nationality	Date of Initial Appointment
Tim Van Hauwermeiren	52	CEO and Executive Director	Belgium	July 15, 2008
Karen Massey	46	COO	Australia	March 13, 2023
Karl Gubitz	55	CFO	South Africa	June 1, 2021
Dr. Peter Ulrichts	45	Chief Scientific Officer	Belgium	January 1, 2023
Malini Moorthy	55	General Counsel	Canada	February 14, 2022
Arjen Lemmen	40	Vice-President Corporate Development & Strategy	The Netherlands	May 1, 2016
Andria Wilk	52	Global Head of Quality	UK	January 13, 2020
Dr. Luc Truyen	60	Chief Medical Officer	Belgium	April 1, 2022

Tim Van Hauwermeiren

Tim Van Hauwermeiren co-founded our Company in 2008 and has served as our CEO since July 2008. He has served as

a member of our Board of Directors since July 2014.


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Mr. Van Hauwermeiren has almost 30 years of general management and business development experience across the life

sciences and consumer goods sectors. He also serves on the boards of directors of iTeos Therapeutics, Inc. and Lexeo

Therapeutics, Inc.

Karen Massey

Karen Massey has served as our COO since March 2023.

Ms. Massey has over 20 years of experience in the pharmaceutical and biotechnology industry, including in commercial,

product development, corporate strategy, and innovation roles. Prior to joining argenx, Ms. Massey was with Genentech

(Roche Group) for over nine years, where she most recently served as senior vice president of product development and

global clinical operations and previously held various commercial leadership roles across marketing and business

operations, including as the vice president of the multiple sclerosis and neuromyelitis optica business. Ms. Massey

started her biopharmaceutical career in marketing at Pfizer Inc., and returned there, after two years as a management

consultant at Bain & Company, to take on leadership positions in corporate strategy and sales and as a commercial lead

in Latin America.

Karl Gubitz

Karl Gubitz has served as our CFO since June 2021.

Mr. Gubitz previously worked at Pfizer Inc. for nearly 20 years, most recently as vice president of finance within the

global oncology business. Within Pfizer Inc., Mr. Gubitz held country, regional, and global positions, and consistently

delivered top-line growth. He managed teams of over 250 colleagues in financial leadership roles within the global

internal medicine and global innovative products businesses. Prior to joining Pfizer Inc. in 2003, Mr. Gubitz held various

management roles at PricewaterhouseCoopers LLP.

Dr. Peter Ulrichts

Peter Ulrichts has served as our chief scientific officer since January 2023. In this role, he oversees the development of

all clinical and pre-clinical compounds within our pipeline.

Dr. Ulrichts previously served in various roles at the Company since he joined us in 2010, including, most recently, as

our head of clinical science. As a research scientist, Dr. Ulrichts was involved in the development of various therapeutic

antibodies for the treatment of cancer and autoimmune diseases. In 2013, he headed the development of our FcRn

antagonist efgartigimod until the first-in-human clinical trial. He subsequently transitioned to become the lead scientist

of our efgartigimod program.

Malini Moorthy

Malini Moorthy has served as our general counsel since February 2022.

She has over 25 years of extensive global legal and compliance experience in the biopharmaceutical and medical device

industries. She was most recently senior vice president and chief deputy general counsel of legal, compliance, and

government affairs at Medtronic plc, where she played a pivotal role in shaping and driving enterprise and functional

strategies. Before joining Medtronic plc, Ms. Moorthy spent four years at Bayer Corporation as the head of global

litigation and investigations and 10 years at Pfizer Inc., where she progressed to lead civil litigation globally. Ms.

Moorthy began her career as a law firm associate, first with McCarthy Tétrault LLP and Genest Murray Desbrisay

Lamek LLP in Toronto, Canada and then Salans LLP (now Dentons US LLP) in New York City.

Dr. Luc Truyen

Luc Truyen has served as our chief medical officer since April 2022 and previously served as our head of research and

development operations management from September 2021 to April 2022.

Prior to this, Dr. Truyen was with Johnson & Johnson (and its subsidiary companies) for over 20 years holding various

leadership positions, primarily within neuroscience. In his most recent position prior to joining argenx, Dr. Truyen was

global head of development and external affairs for neuroscience, managing the strategy and delivery of the early and

late portfolio of assets for mood disorders, schizophrenia, and neurodegenerative and neuroinflammatory disorders.

Besides Dr. Truyen’s strong track record in clinical development resulting in several globally innovative drug approvals,

his broad-based experience also includes leading global clinical development operations for the whole Johnson &


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Johnson pharmaceutical group as well as serving as the head of research and development and chief medical officer of

Janssen Alzheimer Immunotherapy Research & Development LLC, an internal spin-out from Johnson & Johnson.

Arjen Lemmen

Arjen Lemmen joined argenx in 2016 and has served as our vice president of corporate development & strategy since

2019. He has successfully executed several transactions including a number of programs within the IIP.

Prior to joining the Company, Mr. Lemmen served as a corporate finance specialist at Kempen & Co NV focusing on

mergers and acquisitions, equity capital markets and strategic advisory transactions in the European life sciences

industry.

Andria Wilk

Andria Wilk joined argenx as global head of quality in January 2020. Ms. Wilk has more than 25 years of experience in

quality assurance within the pharmaceutical industry. Most recently, Ms. Wilk served as senior director, head of medical,

regulatory & clinical quality assurance at H Lundbeck A/S, where she managed the global medical, regulatory & clinical

quality assurance group based in the EU, U.S., and Asia. In this role, she was responsible for the global audit programs

and quality assurance support for all clinical trial and post-marketing activities and related computerized systems.

Prior to H Lundbeck A/S, she held various quality assurance positions of increasing responsibility within AstraZeneca

plc, Takeda Global Research, Development Centre Europe, and Astellas Pharma Inc.

General Information About Our Directors and Senior Management

As of the date of this Annual Report (or in any period before), none of the members of our Board of Directors and senior

management has or has had a family relationship with any other member of our Board of Directors or senior

management, and there are no arrangements or understandings with major shareholders, customers, suppliers or

others,pursuant to which any person referred to above was selected as a member of our Board of Directors or senior

management. For further information regarding any arrangements pursuant to which our Board of Directors or senior

management were appointed, see “Item 7.B. — Related Party Transactions — Agreements with Our Senior

Management”.

B. COMPENSATION

Remuneration Report and Compensation Statement

Letter of the Chairperson of the Remuneration and Nomination Committee

Dear Stakeholders,

The Remuneration and Nomination Committee is pleased to present the 2024 remuneration report and compensation

statement (the 2024 Remuneration Report). This report outlines the Remuneration and Nomination Committee’s role and

activities over the past financial year and provides an outlook for 2025. It also explains the efforts made to continuously

align our remuneration framework with the interests of the Board of Directors and those of our stakeholders, ensuring

sustainable value creation as argenx evolves.

In line with our current remuneration policy, approved in 2021 (the 2021 Remuneration Policy), and in anticipation of

the revised policy we are submitting for approval at the 2025 General Meeting (the Proposed 2025 Remuneration

Policy), this report highlights our commitment to a remuneration structure that fosters performance-based remuneration

and transparency on targets and long-term alignment. Both policies are designed to ensure that the compensation of the

Board of Directors remains closely tied to the Company’s strategic goals and stakeholder interests.

The CEO’s remuneration, in particular, is structured to include a well-balanced mix of short-term and long-term

incentives. This approach rewards not only immediate achievements, but also sustained progress in our business

strategies, individual objectives, and key strategic non-financial metrics that we believe underpin our long-term mission

and Vision 2030.

On behalf of the Board of Directors, I am pleased to provide insight into how the Company’s achievements and

continued progress in 2024 have shaped the remuneration of our CEO, COO, and CFO (the Named Executive Officers or

NEOs), as well as our Non-Executive Directors.


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This report details the implementation of the 2021 Remuneration Policy, prepared in accordance with the DCGC and the

draft, non-binding disclosure guidelines of the European Commission. It reflects our commitment to transparency and

alignment with best governance practices while ensuring that our remuneration framework supports the Company’s

strategic objectives and long-term value creation.

Looking Back on 2024

In 2024, we conducted our annual comprehensive base pay review for our Named Executive Officers, to ensure our

compensation framework remains competitive and aligned with industry benchmarks. Based on the recommendation of

the Remuneration and Nomination Committee, the Board of Directors approved the following compensation changes:

•The CEO’s base pay increased by 15% to EUR 700,000 ($757,680). While the broader workforce has received

progressive increases in line with Company guidelines over the past two years, the CEO’s base pay remained

unchanged between 2022 and 2023, at his personal request. We believe that the approved base pay increase was

necessary to maintain fairness, ensure market competitiveness, and recognize our CEO’s exceptional leadership in

delivering sustained value to our shareholders. Even after this increase, the CEO’s base pay remains at the 27th

percentile of our newly defined global peer group.

•The COO and CFO each received a 6% base pay increase, reflecting their critical roles and contributions to the

Company’s continued growth and success.

These adjustments reinforce our commitment to a balanced, performance-driven remuneration structure that supports

long-term value creation while maintaining fairness and transparency.

Company Performance

As detailed in our Shareholder Letter, 2024 was a year marked by remarkable progress and significant achievements

such as receiving regulatory approval in Japan for VYVGART for the treatment of adults with ITP and receiving FDA

approval for VYVGART HYTRULO for the treatment of CIDP patients. Our Senior Management Team, including the

Named Executive Officers, navigated multiple hurdles while capitalizing on strategic opportunities. We established our

‘Vision 2030’, a long-term commitment to transforming the treatment of severe autoimmune diseases through innovative

therapies such as VYVGART and VYVGART HYTRULO, empasiprubart, and our expanding pipeline of antibody-

based therapeutics. Over the past year, we have made substantial progress in our ambitious target to treat 50,000 patients

globally, secure 10 labelled indications, and advance five pipeline candidates into Phase 3 development by 2030.

Notably, we reached over 10,000 gMG patients, expanded our global footprint with multiple approvals for gMG and

CIDP (approximately touching approximately1,000 patients), and initiated label-enabling studies that further our reach in

the market.

We have also advanced several key assets:

•efgartigimod has progressed, with GO-decisions announced for SjD to enter into a Phase 3 clinical trial and for

Myositis to continue the Phase 3 clinical trial based on the Phase 2 data.

•empasiprubart has advanced into a Phase 3 clinical trial for MMN and a Phase 3 clinical trial for CIDP will

commence in 1H 2025.

•ARGX-119 has entered proof-of-concept clinical trials in CMS and ALS.

•Four new INDs advancing into Phase 1 clinical trials, further underpinning our commitment to delivering

immunology innovations.

Financially, our strong performance is reflected in reaching $2.2 billion in product net sales, an impressive increase from

$1.2 billion in 2023, along with significant advancements in our clinical pipeline, including 10 Phase 2 clinical trials and

10 Phase 3 clinical trials. These achievements have enabled us to meet or exceed all quantitative short-term incentive

targets, while qualitative metrics relating to building a robust organization were also achieved.

Moreover, the Remuneration and Nomination Committee appreciates the strategic shift driven by our management’s

focus on operational and commercial excellence. This focus has well positioned argenx among its peers to capitalize on

emerging opportunities, particularly in light of the positive Phase 2 proof-of-concept data for empasiprubart, which has

paved the way for its advancement into Phase 3 clinical trial for MMN (EMPASSION).

2021-2024 Performance and Long-Term Incentive Plan Outcome


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As a shareholder, you will be pleased that in 2024, the Euronext Brussels share price rose by 74.7% from €343.50 per

share on the last trading day of 2023 to €600.00 per share on December 31, 2024. In a three-year long-term incentive

(LTI) period between December 31, 2021 and December 31, 2024, the share price rose by approximately 90.3%, from

€315.30 to €600.00 per share.

Stakeholder Engagement and Looking Forward to 2025

Shareholders play a crucial role in our success by providing invaluable support and fostering strong partnerships that are

essential to our growth. We deeply appreciate their continued commitment and strive to keep them well-informed,

ensuring a lasting and productive relationship. In 2024 and 2025 to date, we have actively engaged with our investor

community on several topics, including on the 2023 remuneration report (which led to a positive voting outcome of

58.6%), the proposed 2024 remuneration policy (which led to a voting outcome of 68.9% where a 75% majority was

required) and the Proposed 2025 Remuneration Policy. In 2024, we held over 70 dedicated meetings with shareholders.

As at the date of this Annual Report, we have conducted more than 20 meetings in 2025. These discussions focused on

key remuneration events and have been instrumental in driving continuous improvements in our remuneration practices.

Key points raised during these interactions include:

•We received concerns from stakeholders they were not able to determine if and how pay-for-performance was

embedded in our remuneration. To address this feedback, this 2024 Remuneration Report includes enhanced

disclosure on the 2024 performance targets and corresponding pay-out for the NEOs. We have also introduced

prospective disclosure on the short-term incentive (STI) metrics set for 2025 and for the newly introduced

performance share units (PSUs) against a threshold-target-maximum framework. In the Proposed 2025 Remuneration

Policy, we will commit to this enhanced prospective disclosure against a threshold-target-maximum framework going

forward.

•Feedback indicated that at this stage in the evolution of the Company stock options could be perceived as

performance-based incentives, potentially compromising the objectivity of our Non-Executive Directors. To respond

to feedback from a number of stakeholders and upholding the highest standards of governance and independence, we

decided to no longer grant stock options to Non-Executive Directors as from 2024. Instead, we transitioned to a

remuneration structure based on fixed fees and non-performance-based equity compensation, namely RSUs. This new

structure is aligned with best practices while maintaining fairness and transparency.

•Historically, stock price appreciation was considered an inherent performance target in stock option grants. However,

in response to shareholder feedback, the Proposed 2025 Remuneration Policy introduces a more structured,

performance-driven approach to LTI. Under the revised framework, stock options will be limited to a maximum of

50% of the Executive Director’s total LTI grant, while at minimum 50% will be allocated as PSUs, tied to predefined

performance criteria beyond share price appreciation. To further reinforce this performance-based approach, RSUs

have been eliminated, ensuring that the entire LTI is 100% ‘at-risk’. This fully aligns Executive Director rewards with

long-term value creation and strategic objectives. This refined approach strengthens the link between Executive

Director compensation and sustained company performance while addressing shareholder concerns regarding

performance measurement.

•Some stakeholders expressed concerns regarding the perceived lack of a cap on the LTI awards. In response, the

Proposed 2025 Remuneration Policy introduces a clearly defined cap on total awards as a multiple of base pay.

Notably, the Founder CEO has requested that his target and maximum LTI opportunities be set at 7x and 10x base

pay, respectively. Future incoming Executive Directors will also be subject to capped LTI awards, ensuring

consistency, transparency, and alignment with stakeholder expectations while maintaining a competitive and

performance-driven compensation structure.

•Investor feedback prompted a revision of the vesting profile for stock option grants to enhance alignment with market

best practices. In line with our peers, the Proposed 2025 Remuneration Policy introduces a three-year cliff vest for the

CEO’s stock option grants, replacing the previous monthly vesting schedule that began one year after the grant date.

Additionally, the newly introduced PSUs will also be subject to a three-year cliff vesting schedule, reinforcing a long-

term commitment to performance and shareholder value creation.

•Concerns were raised regarding the Board of Directors’ discretion in granting an additional $98,368 (25% of the

target incentive) in 2023 to the CEO in recognition of the successful execution of the Company’s business plan.

While this discretionary adjustment was deemed appropriate in this instance due to the significant over achievement

of business results, we acknowledge the importance of transparency and a more detailed disclosure of pay-for-

performance approach. In the event of any future discretionary adjustments will be accompanied by detailed


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disclosure of the performance targets and corresponding payouts to ensure clear alignment between compensation and

measurable achievements.

More information on how we further specifically addressed stakeholder concerns, including from our latest engagement in

2025, will be included in the explanatory notes of the Proposed 2025 Remuneration Policy.

We will continue to engage actively with our key stakeholders and proxy advisors throughout 2025 and onwards,

remaining available to address any questions or concerns regarding corporate governance and executive compensation.

Moreover, we foster an open dialogue within our organization, guided by our unified culture and core values of co-

creation, humility, excellence, empowerment and innovation. This underpins our vision for long-term value creation

while balancing the interests of all stakeholders.

Based on ongoing conversations with our shareholders and the positive feedback received regarding the performance of

our Named Executive Officers and the Company’s overall results, I am confident that our current and proposed

remuneration policies effectively support argenx’s strategic and operational objectives.

On behalf of the Remuneration and Nomination Committee,

Dr. Donald deBethizy

Chairperson, Remuneration and Nomination Committee

Introduction

In compliance with article 2:135b of the Dutch Civil Code, the European Shareholder Rights Directive and the DCGC,

this 2024 Remuneration Report contains information on how we implemented our 2021 Remuneration Policy for the

Board of Directors in financial year 2024.

Remuneration in 2025

This 2024 Remuneration Report also provides early insight on remuneration that will be set in financial year 2025, for

example with respect to benchmarking and peer group selection and prospectively regarding STI and LTI targets. This

2024 Remuneration Report also includes information on the Proposed 2025 Remuneration Policy, which will be

submitted to the 2025 General Meeting for a binding vote and which will be available shortly after publication of this

Annual Report. Please refer to “Item 6.B — Compensation — Looking Forward” for more information.

Statement of voting at general meetings

The table below sets out the votes on the remuneration reports and compensation statement of the past years as well as

the votes on the 2021 Remuneration Policy during the annual General Meeting held in 2021. This 2024 Remuneration

Report as well as the Proposed 2025 Remuneration Policy, which will be available shortly after this Annual Report, will

be put to an advisory and binding vote, respectively, at the 2025 General Meeting to be held on May 27, 2025.


Resolution		Percentage of votes cast for the resolution
Resolution to approve the remuneration report (2024 AGM)		58.6%
Resolution to approve the remuneration report (2023 AGM)		44.1%
Resolution to approve the remuneration report (2022 AGM)		51.9%
Resolution to approve the remuneration report (2021 AGM)		76.6%
Resolution to amend the remuneration policy (2021 AGM)		76.6%

2024 Remuneration

2021 Remuneration Policy

The 2021 Remuneration Policy is designed to reward contributions toward achieving Company objectives and

generating long-term stakeholder value. Its primary goal is to offer competitive remuneration packages that align with

market practices in the key regions where the Company competes for talent, ensuring strong support for the Company’s

long-term business strategy.


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To maintain market competitiveness, the Company conducts regular reviews, typically annually but at least once every

three years, of the total remuneration of members of the Board of Directors and members of the Senior Management

Team. These reviews assess both compensation levels and program design, benchmarking against a carefully selected

group of reference companies.

Under the 2021 Remuneration Policy, total compensation is structured to align with or slightly exceed the market median

for fixed compensation, benefits, and short-term variable incentives. The LTI component consists of equity grants, with

award sizes positioned between the 50th and 75th percentile of the global reference group.

The 2021 Remuneration Policy was approved at the 2021 General Meeting with a 76.6% majority vote and is available

on the Company’s website at https://www.argenx.com/investors/governance/remuneration-policy.

Benchmarking and peer group selection in 2024

Under the Proposed 2025 Remuneration Policy, the methodology of benchmarking and peer group selection is different

than described below for determination of 2024 remuneration. Please refer to Section 3.4.9 “Peer Group Selection ”

where we describe the updated benchmarking process, the objective peer group selection criteria and outcome for

remuneration in 2025 in connection with the Proposed 2025 Remuneration Policy.

The 2024 remuneration was determined following a comprehensive benchmarking exercise conducted in the third

quarter of 2023 in collaboration with AON Radford, an independent third-party compensation advisor. To ensure a

globally competitive compensation structure, the Company benchmarked against both U.S. and European peer groups,

reflecting its position as a global company competing for top talent in both regions. This approach supports the execution

of the Company’s business strategy while aligning executive pay with long-term sustainable value creation for

stakeholders.

The following criteria were used to select the peer group for the 2024 remuneration as part of the Company’s benchmark

performed in the third quarter of 2023, ahead of setting the long-term incentive schemes of 2024 in December 2023 and

the annual cash compensation for 2024 in the first quarter of 2024:

•Sector: Biotechnology and Pharmaceutical industries

•Stage of development: market companies

•Market Capitalization: 1/4x – 3x argenx’s 30‐day average market value as of November 2023, corresponding

with a market capitalization between $5 ‐ 60 billion

•Revenue: 1/4x – 3x argenx’s trailing 12 months revenue, corresponding with an annual revenue between $160 million

-$2 billion

•Headcount (secondary criteria): 1/3x – 3x argenx’s projected financial year ended December 31, 2023 corresponding

with a headcount between 400‐4,000 employees

With the goal of arriving at a sufficiently sized U.S. and EU peer group of at least 15 peer companies disclosing detailed

compensation information, a number of companies were added to the European peer group following a qualitative

review by AON Radford to identify companies with relevant similarities in business model and therapeutic focus. This

led to the following selection of peer companies used by us in the 2023 benchmark for the 2024 remuneration:


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Company name		Country of Headquarters
ACADIA Pharmaceuticals Inc.		USA
Alnylam Pharmaceuticals, Inc.		USA
Amicus Therapeutics, Inc.		USA
BeiGene, Ltd.		Cayman Islands
BioMarin Pharmaceutical Inc.		USA
Blueprint Medicines Corporation		USA
CRISPR Therapeutics AG		Switzerland
Exelixis, Inc.		USA
Incyte Corporation		USA
Intra-Cellular Therapies, Inc.		USA
Ionis Pharmaceuticals, Inc.		USA
Neurocrine Biosciences, Inc.		USA
Sarepta Therapeutics, Inc.		USA
Seagen Inc. (formerly Seattle Genetics, Inc.)		USA
United Therapeutics Corporation		USA

Award levels

Our Board of Directors sets award levels based on the outcome of our benchmarking exercise. Our 2021 remuneration

policy, contains the following framework:


	Non-Executive Directors	Senior Management Team (including the CEO)
Cash-based compensation (base pay + STI)	50th percentile of the companies in Reference Peer Group	50th percentile of the companies in Reference Peer Group
Equity-based compensation (LTI)	50th percentile of the companies in Reference Peer Group	Between the 50th to 75th percentile of the companies in Reference Peer Group

Application of the 2021 Remuneration Policy in 2024

Named Executive Officer Remuneration during 2024

This chapter contains a detailed overview of the remuneration paid for the year ended December 31, 2024 to the NEOs.

Of the NEOs, only the CEO is a statutory director in the Board of Directors. The remuneration of the NEOs in 2024

consisted of base pay and benefits, STI pay in the form of variable cash remuneration, and LTI pay in the form of

Company equity, consisting of stock options and restricted stock units (RSUs).

Total Named Executive Officer Remuneration

The majority of NEO compensation is provided in the form of variable remuneration, which is a combination of

performance-dependent (short-term cash incentives) and stock options and service-dependent (RSUs) compensation.

Variable (short-term) compensation allows the Board of Directors to set challenging annual objectives aligning the

priorities of the NEOs with the short-term strategic objectives of the Company. Company equity in the form of stock

options provides an incentive to the NEOs to contribute to Company (stock price) value increase over the long-term (3

years) vesting period of the stock options. Company equity in the form of RSUs also provides an incentive for value

creation over the long-term (4 years) vesting period of the RSUs. The combination of variable pay in the form of cash-

award STI pay, and stock option based and RSU based LTI pay, ensures a balanced incentive for short-term focus on and

performance of near-term strategic targets, while contributing to sustainable long-term value creation and ensuring long-

term commitment (retention) of the executive. In addition, the Company provides severance arrangements as applicable

for the industry and pension and fringe benefits, including a performance based corporate bonus for all employees in the

Company of up to €3,948 ($4,266) in accordance with Belgian practice. Moreover, in accordance with the DCGC, when


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determining the remuneration package of the executives, scenario analyses are performed annually and taken into

account in setting the total remuneration levels and target and maximum awards under the STI and LTI plans.

Base pay

In 2024, compared to 2023, the base pay of the NEOs was increased in line with the total argenx employee population

annual base pay increase guidelines (CEO +15%, COO +6%, CFO +6%). The increases for the NEOs followed a review

of the individual’s performance over the preceding year(s), in light of comprehensive analysis of benchmark data

showing the relative positioning of base salaries compared to the relevant external and internal peers. This process

ensures that the Company’s compensation packages are a fair reflection of individual performance while also remaining

competitive and aligned with the market. The merit principles and base pay increase framework applied are identical to

those applicable to all employees in the organization and are based on the individuals’ performance and contributions

over the preceding period.

With respect to the CEO, at his request his base pay remained unchanged between 2022 and 2023; accordingly, the

increase in 2024 was the first increase since then. This increase was deemed necessary to ensure fairness in light of

industry benchmarks and to recognize the continued outstanding commitment and performance of the CEO in delivering

exceptional value to our shareholders. Even with this adjustment, the CEO places only at the 27th percentile of our new

global peer group for base pay.

With respect to the COO, the Board of Directors recognized the outstanding performance and the achievement and over

achievement of short-term targets. Consequently, and in line with pay practice applied consistently across the wider

workforce, the COO’s base pay was increased by 6.1% in 2024 versus 2023. The increase consisted of a merit increase

and an additional base pay increase to recognize her exceptional performance mentioned above, her competitive

placement versus the benchmark data and her critical role in our ongoing success.

With respect to the CFO, the Board of Directors recognized outstanding performance for the second year in a row in

2024, including achievement and over achievement of short-term targets, and established that the CFO’s base pay was

still below the midpoint for base pay for CFOs in the reference peer group. Consequently, and in line with pay practice

applied consistently across the wider workforce, the CFO’s base pay was increased by 6% in 2024 versus 2023,

consisting of a merit increase and an additional base pay increase to move the CFO closer to the benchmarked midpoint.

The base pay increase was consistent with the base pay increase of 6% between 2023 and 2022.

Please refer to “Item 6.B — Compensation — Total Named Executive Officer Remuneration” for an overview of the total

value of the remuneration paid to the NEOs for the last 3 years.

Variable Cash

The NEOs were eligible for a variable cash payment for the performance of pre-defined short-term performance targets

in 2024, with the target variable cash compensation set as a percentage of their base pay (60% for CEO, 50% for COO

and 40% for CFO). The Board of Directors has set a cap of 200% pay-out per target, and a 200% overall pay-out cap.

The Board of Directors evaluated the pay-out of each target, with ‘at target’, ‘maximum per target’ and ‘actual pay-out’

explained in detail in the table below.


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CEO

When considering the variable pay pay-out of the CEO, the Board of Directors primarily reviewed whether the key objectives of the Company’s business plan for

2024 were achieved.

Personal targets set for the CEO, in addition to his overall responsibility for delivering the business plan, were the following:

Performance Metric

and Weighting

Measurement

(how the Board of Directors

evaluated the target)

Threshold

Target

Max

Achievement

Vesting

Actual

pay-out

(USD) 1)

Embed our culture and

innovation mission (25%)

•Integrating our newly hired

people through dedicated

culture/ways of working

sessions organized with our

global managers and culture

champions

•Champion four innovation

initiatives

N/A

Key hires successfully

onboarded and

4 innovation initiatives

championed

N/A

•Key hires successfully

onboarded and

•5 innovation

initiatives

championed

25%

227,304

Talent development (25%)

Internal leadership talent pool assessed,

increased and enhanced through direct

personal involvement in the Personal

Development Plan of undisclosed

number of key high potentials and future

Company leaders

> 50

50%

227,304

Deliver continued

VYVGART growth (25%)

•Global annual operating budget

revenue targets ($ targets)

(75%)

•New launches (patient on drug

target (25%)

80% of annual

operating budget

target

100% annual operating

budget target

120% annual

operating budget

target

> 120% annual operating

budget target

50%

227,304

Advance the Pipeline (25%)

10 high quality IIP programs per

OGSM definition

•4 INDs on track for 2025

•MMN on accelerated path

•8 IIP Programs

and

•3 INDs on

track and

•IND accepted

•10 IIP programs and

•4 INDs on track and

•First site activated

Minimum 2 out of 3:

•12 IIP programs

and/or

•5 INDs on track

and/or

•First patient

randomized

•11 IIP programs

delivered

•5 INDs on track

•First patient

randomized

50%

113,652

1)Amounts paid out in Euro have been converted to USD using the average rate for the period of 1.0824 EUR/USD.


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COO

When considering the variable pay pay-out of the COO, the Board of Directors primarily reviewed whether the following key objectives of the Company’s business

plan for which the COO had key responsibilities for 2024 were achieved.

Personal targets set for the COO, in addition to her overall responsibility for delivering commercial performance, were the following:

Performance Metric

and Weighting

Measurement

(how the Board of Directors

evaluated the target)

Threshold

Target

Max

Achievement

Vesting

Actual

pay-out

(USD) 1)

Scale commercial engine by

leveraging the new operating

model (25%)

Successful onboarding of key hires

and cross-functional indication

teams delivering their OGSMs

Key hires

successfully

onboarded with

max 2 attritions

Key hires successfully

onboarded with no

attrition

AND

80% of OGSM targets

delivered

Key hires

successfully

onboarded with no

attrition AND

90% of OGSM

targets delivered

•Key hires successfully

onboarded with no

attrition AND

•90% of OGSM targets

delivered

50%

168,741

Integrate our newly hired

colleagues to the argenx

culture and operating

principles, leveraging the

operating excellence model

to create a global network of

leaders (25%)

Measured by operating excellence

model self-assessment

At least 3

significant, global

operational wins

by applying

operating

principles

At least 5 significant,

global operational wins

by applying operating

principles

At least 7 significant,

global operational

wins by applying

operating principles

At least 7 significant,

global operational wins

by applying operating

principles

50%

168,741

Deliver continued

VYVGART growth (25%)

•Global annual operating budget

revenue targets ($ targets)

(75%)

•New launches (patient on drug

target (25%)

80% of annual

operating budget

target

100% annual operating

budget target

120% annual

operating budget

target

> 120% annual operating

budget target

50%

168,741

PFS with self-administration

delivered according to plan,

maintaining subcutaneous

Gen-1 option (25%)

FDA acceptance

FDA acceptance with no

concerns and review on

track

FDA acceptance with

PDUFA date < 6

months

FDA acceptance with no

concerns and review on

track

25%

84,371

CFO

When considering the variable pay pay-out of the CFO, the Board of Directors primarily reviewed whether the key commercial and operational objectives of the

Company’s business plan for 2024 were achieved.

The personal targets set for the CFO, in addition to his overall responsibility for delivering commercial performance, were the following:


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Performance Metric

and Weighting

Measurement

(how the Board of Directors

evaluated the target)

Threshold

Target

Max

Achievement

Vesting

Actual

pay-out

(USD)

ERP process simplification

& time reduction (25%):

•Simplify project

management module;

embed forecasting

capabilities and insight

generation

•Global process owner

automation &

centralization

Measured by successful completion

of projects and internal customer

feedback

75% of projects

successfully

delivered

85% of projects

successfully delivered

100% of projects

successfully

delivered

85% of projects delivered

25%

55,300

Protect and preserve

company and critical assets

(25%):

•Strong audit ratings from

internal & external audits

•Partnership with audit

and compliance

committee

•Sustainable future tax

rate

•Working capital

•Audit and compliance

committee partnership:

measured by feedback

•Sustainable future tax rate:

measured by filings of key

rulings (US Bilateral Advance

Pricing Arrangements,

expanded Belgian Innovation

Income Deduction ruling for

ARGX-113 IV & SC for CIDP

and ITP, Switzerland, and

Japan)

•Working capital: measured

against agreed terms

•No major

findings

external

•Audit and

Compliance

Committee

rates

partnership

with CFO as

"strong" (7+)

•US ruling filed

•Annual

operating

budget + 10%

•No major findings

internal & external

audit

•Audit and Compliance

Committee rates

partnership as very

strong (8+)

•US + Japan rulings

filed

•Annual operating

budget

•No major

findings internal

& external audit

and no minor

findings external

•Audit and

Compliance

Committee rates

partnership as

excellent (9+)

•US / Japan /

Switzerland

rulings filed

•Annual operating

budget -10%

•No major internal &

external audit findings

•Audit and Compliance

Committee rates

partnership as 9+

•US and Japan rulings

filed

•Annual operating

budget -10%

25%

55,300

Deliver continued

VYVGART growth (25%)

•Global annual operating budget

revenue targets ($ targets)

(75%)

•New launches (patient on drug

target) (25%)

80% of annual

operating budget

target

100% annual operating

budget target

120% annual

operating budget

target

> 120% annual operating

budget target

50%

110,600

Ensure internal and external

alignment of expectations

and grow investor base

(25%)

•Analyst expectations vs actual

revenue disclosed per quarter,

measured by average % change

in Nasdaq stock price on the

trading day of earnings

communications (50%)

•Add generalist shareholders to

the top 35 list (50%)

On average no

more than 20%

change and 1

generalist

shareholder added

On average no more than

10% change and 2

generalist shareholder

added

On average no more

than 5% change and

4 generalist

shareholders added

Average change of 4%

and 4 generalist

shareholders added

50%

110,600


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Corporate Bonus

All employees are eligible to annually earn a performance based corporate bonus with a maximum value of €3,948

($4,266) per year, based on three equally weighted Company-wide goals. In 2024, the targets focused on (i) continued

increased cybersecurity awareness, (ii) building argenx together by bringing the cultural pillars and operating principles

to life through participation in Culture Labs, and (iii) supporting development and growth of all employees through

personal development plans. A pay-out of €3,350 ($3,636) was made to all employees.

Equity

In 2024, the Company granted a mix of stock options and RSUs to the NEOs. The number of instruments to be granted

in the course of 2024 was determined pursuant to the annual benchmark exercise performed with the help of AON

Radford. This benchmark exercise takes place in the third quarter of each calendar year.

Determination of target value of CEO equity grant

For the 2023 CEO equity granted on the first business day in July 2023, being July 3, 2023, the determination of the

target value for the CEO followed the below steps:

•The total target value of $6,986,986 was established in the third quarter of 2022.

•Immediately thereafter, the target value was subsequently converted into a fixed number of stock options and RSUs to

be granted on the grant date of July 3, 2023.

•For the conversion into a fixed number of stock options; a Black-Scholes value of $151.03 per stock option was used

based on the 30-day average stock price of $366.58 before July 22, 2022. Based on this valuation, the number of

stock options to be granted on July 3, 2023 was fixed at 30,000 stock options.

•For the conversion into a fixed number of RSUs; the value of $366.58 per RSU was based on the 30-day average

stock price of $366.58 before July 22, 2022. Based on this valuation, the number of RSUs to be granted on July 3,

2023 was fixed at 6,700 RSUs.

•Consequently, the fixed number of stock options and RSUs, 30,000 and 6,700 respectively, were embedded in the

2023 equity allocation scheme.

•On the grant date of July 3, 2023, the stock price was $389.73 compared to $366.58 on the date on which the number

of stock options and RSUs were fixed following conversion of the target value.

•This resulted in a value at grant on July 3, 2023 of $8,084,605 compared to the target value of $6,986,986 in the third

quarter of 2022. This difference is explained by the stock price increase in the intervening period.1)

•Consequently, by fixing the number of equity instruments in the third quarter of 2022 while the grant takes place in

the second quarter of the next year, any positive or negative fluctuations in the stock price between the third quarter of

2022 and July 3, 2023 were not taken into account.

The same determination methodology was followed between the approval of the 2021 Remuneration Policy and 2024.

Updated determination of target value of CEO equity grant as of 2024

As referenced in the 2023 remuneration report, the Company took concrete steps in 2024 to close the time gap between

the benchmarking exercise when determining the target value. The below steps have been followed in 2024 for the

determination of the target value for the CEO:

•The total target value of $7,080,000 was established in the third quarter of 2023.

•In contrast to 2023, the target value was not immediately converted into a fixed number of stock options and RSUs.

1)These amounts do not reflect the actual economic value realized by the beneficiary. Amounts included represent the expenses with respect to the

assumptions used in the Black-Scholes model differ between Belgian beneficiaries versus non-Belgian beneficiaries, resulting in the CEO’s stock

based compensation expenses to be higher than other beneficiaries. For a description of the assumptions used, see ”


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•Instead, the number of stock options was calculated by dividing the target value through the then applicable Black-

Scholes value based on 30 calendar days preceding the 15th day of the month in which the grant occurs (the Reference

Date), rounded up to the nearest whole number granted as stock options.

•The numbers of RSUs was calculated by dividing the target value through the average closing price 30 calendar days

preceding the Reference Date, rounded up to the nearest whole number granted as RSUs.

•The 30-calendar day average closing price on June 15, 2024 was $375.68.

•Consequently, 18,279 stock options and 6,672 RSUs were granted on the grant date of June 28, 2024.

•The stock price on the day preceding the grant of June 28, 2024 was $445.76 compared to the 30-calendar day

average of $375.68 on the Reference Date of June 15, 2024.

•This resulted in a total value at grant on June 28, 2024 of $6,209,313 compared to the target value of $5,080,000 on

the Reference Date of June 15, 2024. This difference is explained by the stock price increase in the intervening

period.2)

•Even though the time period between the valuation date and grant date has been drastically reduced from 8 months to

2 weeks, stock fluctuations whether positive or negative, will still influence the grant value compared to the target

value. For instance, in 2024, we announced the FDA approval of VYVGART HYTRULO for CIDP on June 21,

2024, which positively influenced the stock price between June 15, 2024 and July 1, 2024.

The above determination methodology will be applied going forward, irrespective of whether the Proposed 2025

Remuneration Policy will be approved. It will for the first time be used for the determination of the 2025 target value for

stock options and PSUs.

2)These amounts do not reflect the actual economic value realized by the beneficiary. Amounts included represent the expenses with respect to the

assumptions used in the Black-Scholes model differ between Belgian beneficiaries versus non-Belgian beneficiaries, resulting in the CEO’s stock

based compensation expenses to be higher than other beneficiaries. For a description of the assumptions used, see “


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The following table sets out the number, value and key terms of equity instruments granted to the NEOs in 2024:


	RSUs granted in 2024						Stock options granted in 2024
Name	# RSUs	Key terms	Value at grant in $		Benchmark value in $		# Stock options	Exercise price in €		Exercise price in $		Key terms	Value at grant in $ 1)		Benchmark value in $ 1)		Total
Tim Van Hauwermeiren, CEO	6,762	RSUs vest and are settled in 4 equal installments of 25% over a 4 year period		3,014,500		2,540,348	18,279		416.40		445.76	1/3 vests after year 1 2/3 vest in monthly installments in year 2 and 3 Options not exercisable until the 4th calendar year after the grant year		3,194,813		2,540,050	6,209,313
Karen Massey, COO	4,712			2,100,610		1,770,204	12,738		416.40		445.76	1/3 vests after year 1 2/3 vest in monthly installments in year 2 and 3		2,018,973		1,770,072	4,119,583
Karl Gubitz, CFO	4,712			2,100,610		1,770,204	12,738		416.40		445.76			2,018,973		1,770,072	4,119,583

1)Amounts shown represent the expenses with respect to stock options measured using the Black-Scholes model. For a description of the assumptions used in valuing these awards, see “Note 13 — Share-

Based Payments” to our Consolidated Financial Statements which are appended to our Annual Report for the period ended December 31, 2024 and which are incorporated herein by reference. Based on

the approved 2024 equity allocation scheme, the total equity target value for Tim Van Hauwermeiren is equal to $5,080,000 and the total equity target value for Karen Massey and Karl Gubitz is equal

to $3,040,000 for each. The CEO, COO and CFO received their respective equity grants at target value converted into a number of stock options and RSUs on the Reference Date of the 30-days average

share price of $375.68 per share preceding the Reference Date and the Black-Scholes model fair market value of $138.96 per stock option. This results in the number of stock options and RSUs shown

above. The amounts shown above represent the actual value received at the grant date of June 28, 2024 at which date the Company’s share price was equal to $445.76. The difference of $70.08 per share

is explained by the stock price increase in the intervening period primarily due to approval of VYVGART HYTRULO for CIDP in the U.S. by the FDA. For more information on the CEO equity grant,

please refer to “Item 6. B — Compensation — Equity — Determination of target value of CEO equity grant” above. The fair market value based on the Black-Scholes model for Tim Van Hauwermeiren

is $174.78 and the fair market value for the COO and CFO is $158.50. These amounts do not reflect the actual economic value realized by the beneficiary. Amounts shown represent the expenses with

respect to the stock options awards granted in 2024 measured using the Black-Scholes model with unobservable assumptions. The assumptions used in the fair valuation differ between Belgian

beneficiary versus non-Belgian beneficiary. For a description of the assumptions used in valuing these awards, see “Note 13 — Share-Based Payments“ to our Consolidated Financial Statements which

are appended to our Annual Report for the period ended December 31, 2024 and which are incorporated herein by reference.


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Pension and fringe benefits

The benefits paid to the NEOs are jurisdiction dependent. For the CEO, these included benefits customary in the Belgian

market, and which are standard components of Belgian-based employee packages: pension contributions, a

hospitalization insurance, a representation allowance and a company car. The Company pension contribution percentage

of base pay for the CEO is equal to the Company pension contribution percentage for all employees in Belgium. For the

COO, these included benefits customary in the Swiss market, and which are standard components of Switzerland-based

employee packages: car allowance, lunch allowance, health insurance allowance, representation allowance and pension

contributions For the CFO, these included benefits customary in the U.S. market, and which are standard components of

our U.S.-based employee packages: a company-administered health and 401k plan, with a 4% company match.

Equity holding requirements for Named Executive Officers

In 2023, the Company implemented the following holding requirements for the Named Executive Officers :

•CEO: 3x base pay

•Other NEOs: 1x base pay

The minimum equity stake has to be built up over a maximum of five years and continues to apply for the duration of

employment and for two years thereafter.

Severance arrangements

In accordance with our 2021 Remuneration Policy, the CEO has an 18-month notice period for termination (or

alternatively, 12 months severance in lieu of notice). For the other NEOs, no contractual arrangements have been made

for severance.

In the year ended December 31, 2024, no severance payments were granted to the NEOs.

Clawback policy

In the event that any variable remuneration (cash or equity) is paid to members of the Senior Management Team,

including the NEOs, based on financial information which later proves to be incorrect and leads to an accounting

restatement (i) due to the material noncompliance of the Company with any financial reporting requirement under

applicable securities laws, including any required accounting restatement to correct an error in previously issued

financial statements of the Company that is material to the previously issued financial statements of the Company, or (ii)

that corrects an error that is not material to previously issued financial statements of the Company, but would result in a

material misstatement if the error were corrected in the current period or left uncorrected in the current period, then the

difference between the paid compensation and the compensation which would have been payable without such

accounting restatement, shall be claimed back from the executive, all as further set out in the Executive Compensation

Clawback Policy, as adopted by the Board of Directors on July 25, 2023.

In the year ended December 31, 2024, no variable remuneration was clawed back and no variable remuneration was

adjusted (retroactively).

If the Proposed 2025 Remuneration Policy is approved at the 2025 General Meeting, new management agreements that

are entered into with the Company will not have notice periods exceeding 12 months unless otherwise required by local

law. No severance arrangements will be paid in the event of serious culpable or negligent behavior on the part of an

Executive Director being dismissed. We also will not pay severance if the agreement is terminated at the initiative of an

Executive Director, other than due to serious culpable conduct or neglect on the part of the Company.

Remuneration of Other Members of the Senior Management Team

For the purposes of U.S. governance reporting requirements, all senior level employees reporting directly to the CEO

qualify as the Company’s ‘executives’. The remuneration disclosures in relation to this more extensive group of senior

personnel (excluding the NEOs) in this 2024 Remuneration Report is presented on an aggregated basis, with the

exception of equity remuneration, which is presented on an individual basis.

Aggregate compensation for other members of the Senior Management Team


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The following table sets forth information regarding aggregate compensation paid to members of the Senior

Management Team (other than the NEOs) during the year ended December 31, 2024.


(in $)		Compensation
Base pay		2,563,047
Corporate bonus		—
Variable STI 1)		1,376,604
Compensation in the form of stock options		10,525,234
Compensation in the form of RSUs		8,994,991
Other benefits 2)		4,095,467
Total		27,555,343

1)Variable STI includes a performance based Company wide corporate bonus of $3,636 per member of the Senior Management Team.

2)Other benefits consists of the lease of a company car, employer-paid medical insurance premiums, pension contributions, social security costs

and allowance. In 2024, employer social security costs were impacted by the increase of share-price at year end against the share-price as of

December 31, 2023.

For more information on equity granted to members of the Senior Management Team (other than the NEOs), during

2024, please refer to “Item 6.B. — Compensation — Summary of Other members of the Senior Management Team”

below.

Non-Executive Director Remuneration

Pursuant to the 2021 Remuneration Policy, the remuneration of the Non-Executive Directors consists of (i) a cash

retainer fee calculated on the basis of their membership or chairpersonship of the Board of Directors and/or its

committees, and (ii) a long-term equity incentive in the form of stock options and RSUs. One of the key points raised by

stakeholders in respect of the 2021Remuneration Policy was that granting stock options to Non-Executive Directors may

be perceived as performance-based remuneration, potentially affecting the objectivity of our Non-Executive Directors.

To address this concern, the Company decided to no longer grant stock options to Non-Executive Directors as of 2024.

Consequently, in 2024, the remuneration of the Non-Executive Directors consisted of cash retainer fees and RSUs. Our

Proposed 2025 Remuneration Policy will formally reflect this change.

Total Non-Executive Director remuneration

The following table sets forth the information regarding the remuneration earned by the Non-Executive Directors during

the year ended December 31, 2024:


Name	Cash retainer fees earned or paid in cash (in $)	RSU awards (in $) 1)	Total (in $)
Mr. Peter Verhaeghe	117,500	474,734	592,234
Mr. Steve Krognes	85,000	474,734	559,734
Dr. Pamela Klein	70,000	474,734	544,734
Dr. Donald deBethizy	90,000	474,734	564,734
Anthony Rosenberg	82,500	474,734	557,234
James Daly	92,500	474,734	567,234
Camilla Sylvest	70,000	474,734	544,734
Dr. Ana Cespedes	70,000	474,734	544,734
Dr. Brian Kotzin	53,333	712,324 2)	765,657

1) There is a difference between the annual equity compensation target amount of $400,000 and the value at grant of $474,777. On the Reference Date,

the annual equity compensation target amount of $400,000 was divided by the average closing price of the Company’s shares of $375.68 30

calendar days preceding the Reference Date. The Company’s share price on the grant date of June 28, 2024 was $445.76. The difference of $70.08

per share is explained by the share price increase in the intervening period primarily due to approval of VYVGART HYTRULO for CIDP in the

U.S. by the FDA.


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Annual cash

The Board of Directors has set the annual cash retainer fees, including for members of the Audit and Compliance Committee, the research and development

committee, the Remuneration and Nomination Committee and the commercial committee and, in each case, the additional remuneration for the respective chairperson

as follows. In 2024, the annual cash retainer fees were at the 50th percentile of cash remuneration in the peer group for 2024 remuneration.


			In $
Relevant body	Position	Fees in $	Mr. Peter Verhaeghe	Mr. Steve Krognes	Dr. Pamela Klein	Dr. Donald deBethizy	Anthony Rosenberg	James Daly	Camilla Sylvest	Dr. Ana Cespedes	Dr. Brian Kotzin
Board of Directors	Chairperson	95,000	95,000	—	—	—	—	—	—	—
Board of Directors	Member	60,000	—	60,000	60,000	60,000	60,000	60,000	60,000	60,000	40,000
Audit & Compliance Committee	Chairperson	25,000	—	25,000	—	—	—	—	—	—	—
Audit & Compliance Committee	Member	12,500	12,500	—	—	—	12,500	12,500	—	—	—
Remuneration & Nomination Committee	Chairperson	20,000	—	—	—	20,000	—	—	—	—	—
Remuneration & Nomination Committee	Member	10,000	10,000	—	—	—	—	—	—	10,000	—
Commercial Committee	Chairperson	20,000	—	—	—	—	—	20,000	—	—	—
Commercial Committee	Member	10,000	—	—	—	—	10,000	—	10,000	—	—
Research & Development Committee	Chairperson	20,000	—	—	—	—	—	—	—	—	13,333
Research & Development Committee	Member	10,000	—	—	10,000	10,000	—	—	—	—	—
Total			117,500	85,000	70,000	90,000	82,500	92,500	70,000	70,000	53,333

Equity compensation

In 2024, the Non-Executive Directors received only RSUs. The target amount of $400,000 was at the 50th percentile of the peer group for 2024 remuneration:


	RSUs granted in 2024
Name	# RSUs	Key terms	Value at grant in $ 1)		Total
Mr. Peter Verhaeghe	1,065	RSUs granted in 2024 vest after 1 year and are subject to a 3-year holding period from the date of grant		474,734		474,734
Mr. Steve Krognes	1,065			474,734		474,734
Dr. Pamela Klein	1,065			474,734		474,734
Dr. Donald deBethizy	1,065			474,734		474,734
Anthony Rosenberg	1,065			474,734		474,734
James Daly	1,065			474,734		474,734
Camilla Sylvest	1,065			474,734		474,734
Dr. Ana Cespedes	1,065			474,734		474,734
Dr. Brian Kotzin	1,598 2)			712,324 2)		712,324 2)

1)There is a difference between the annual equity compensation target amount of $400,000 and the value at grant of $474,777. On the Reference Date, the annual equity compensation target amount of

$400,000 was divided by the average closing price of the Company’s shares of $375.68 30 calendar days preceding the Reference Date. The Company’s share price on the grant date of June 28, 2024

was $445.76. The difference of $70.08 per share is explained by the share price increase in the intervening period primarily due to approval of VYVGART HYTRULO for CIDP in the U.S. by the FDA.

2)Dr. Brian Kotzin joined the Board of Directors in May 2024 and pursuant to the 2021 Remuneration Policy and 2024 equity allocation scheme, he was eligible to a sign-on grant representing an

additional 50% (equal to $200,000) of the Non-Executive Director annual equity compensation target amount.


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Holding requirements

In 2023, the Company implemented the following holding requirements for Non-Executive Directors: 3x annual Board

of Director membership retainer fees worth of Company stock for the duration of their role.

The minimum equity stake is required to be built up over a maximum of five years and continues to apply for the

duration of their role and for at least two years after departure.

In the Proposed 2025 Remuneration Policy, the Company is further revising this. It is proposed that a Non-Executive

Director is required to hold at least 5x annual Board of Director membership retainer fees (as at the date of this Annual

Report USD 60,000) worth of Company stock for the duration of their role.

Severance arrangements

In the year ended December 31, 2024, no severance payments were granted to the Non-Executive Directors.

Non-Executive Director equity treatment on departure

In 2023, the Company updated the terms of the Equity Incentive Plan applicable to Non-Executive Directors, with

respect to leaver rules. In particular, and following shareholder feedback on the potential negative impact of having

multi-year service based vesting requirements for Non-Executive Director equity, the Equity Incentive Plan was updated

to reflect that Non-Executive Directors will lose their unvested equity if they are dismissed at the general meeting, but

not if they resign on their own initiative or if, at the end of their term, they do not apply for re-appointment.

In the proposed 2024 remuneration policy, the Company proposed a 1-year vest term combined with a 3-year post vest

holding requirement. Despite the proposed 2024 remuneration policy not being approved in the 2024 General Meeting,

we applied this updated vesting term and post-vest holding requirement to the RSUs granted to Non-Executive Directors

in 2024 to address shareholder feedback. In the Proposed 2025 Remuneration Policy, the Company is further revising

this. It is proposed that all RSUs granted will not be subject to any vesting conditions and that no RSUs may be sold until

after the 4th anniversary of the grant date, except to the extent necessary to cover immediate tax obligations resulting

from the grant.

Pay Ratios

Overall pay ratios

The total expense for the non-equity remuneration paid to the CEO (being the only statutory Executive Director on the

Board of Directors) for the year ended December 31, 2024, totalled $1,598,471. The table below shows the evolution

over the past five years of CEO compensation, the performance of the Company’s stock price and the median

remuneration on a full-time equivalent basis (annualized for the employees who joined or left us during the year) of

employees, other than the CEO:


		2020	2021	2022	2023		2024
Base pay of the CEO (EUR)	€	525,000	551,250	606,368	606,368		700,000
Base pay of the CEO (USD)	$	553,167	580,825	638,901	655,787		757,680
Non-equity remuneration of the CEO (USD) (base pay, short-term cash incentive, pension contributions and other compensation elements)	$	1,144,301	1,285,136	1,443,925	1,285,056		1,598,471
Total remuneration of the CEO (USD) (non-equity remuneration, STI and LTI)	$	8,160,745	7,263,828	7,778,298	11,944,835 1)	1 )	7,807,786
Non-equity median salary paid to employees (USD)	$	163,062	157,349	153,193	159,500		180,543
Non-equity remuneration ratio employee/CEO		14%	12%	11%	12% 2)		11%
Average remuneration paid to Non-Executive Director (USD)	$	57,925	54,484	48,587	59,230		81,204
Number of employees on December 31		336	650	843	1,148		1,599
Share price at end of year Euronext (EUR) on December 31	€	242.00	315.30	348.30	343.50		600.00
Share price at end of year Euronext (USD) on December 31	$	296.96	357.11	371.50	379.57		623.34


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1)Based on the approved 2023 equity allocation scheme, the total equity target value for Tim Van Hauwermeiren is equal to $6,986,986. Please

refer to “Item 6.B. — Compensation — Equity — Determination of target value of CEO equity grant ” above for more information on the

variation in granted equity value between 2023 and 2024.

2)The increase in the remuneration ratio between the CEO and other employees between 2022 and 2023 is caused by the increase in salary of

employees when base salary of the CEO remained unchanged.

The comparison of non-equity compensation above is made between the compensation paid to the CEO, the Company’s

sole statutory Executive Director on the Board of Directors, and the median compensation paid to employees. The

Company has opted to compare non-equity salaries, because whereas the number of stock options granted is linked to the

overall size of remuneration packages granted, the value of equity components depends on the evolution of the

Company’s share price, volatility and the risk-free rate, which is unknown at the time of grant and as such the forward-

looking valuation methods for stock options normally do not provide an accurate representation of actual economic value

granted. In the assumptions used, the fair valuation differs between a Belgian beneficiary versus a non-Belgian

beneficiary. For a description of the assumptions used in valuing these awards, please refer to “Note 13 — Share-Based

Payments in our consolidated financial statements which are appended to our Annual Report for the period ended

December 31, 2024 and which are incorporated therein by reference.

Regional pay ratios

Due to the global spread of employees over multiple continents, it is deemed relevant to also include the above

comparison separately to U.S. employees, EU employees and Japanese employees. Due to the overall higher

compensation level in the business segment in the U.S. compared to the EU, there is a significant difference in the pay

ratio when the CEO’s compensation is compared to the median compensation of all employees, compared to employees

in the U.S. The following information is provided for reference purposes:


Ratio of non-equity compensation of the median employee compared to the CEO for the year ended December 31, 2024
All employees		11%
European employees		7%
North-America Employees		16%
Japan employees		5%

Total employment costs (excluding any costs related stock options and RSUs) paid in the year ended December 31, 2024

was split between regions as follows:


Total employment costs in the year ended December 31, 2024
(in millions of $)
Europe		186.7
North-America		204.9
Japan		13.9


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Share-based payment ratios


	2020	2021	2022	2023	2024
Stock options granted to the CEO	50,000	25,000	25,000	30,000	18,279
Median stock options granted to employees	2,900	981	900	600	306
Ratio employee/CEO for stock options	6%	4%	4%	2%	2%
RSUs granted to the CEO	N/A	5,700	5,700	6,700	6,762
Median RSUs granted to the employees	N/A	200	200	94	148
Ratio employee/CEO for RSUs	N/A	4%	4%	1%	2%
Median number of stock options granted to Non-Executive Directors	10,000	2,700	2,700	1,600	N/A
Median stock options granted to employees	2,900	981	900	600	306
Ratio Non-Executive Directors/employee stock options	29%	36%	33%	38%	N/A
Median number of RSUs granted to Non-Executive Directors	N/A	600	600	350	1,124
Ratio Non-Executive Directors/employee RSUs	N/A	33%	33%	27%	13%

Other Disclosures

Remuneration by subsidiaries

In the year ended December 31, 2024, no remuneration was granted and allocated by subsidiaries or other companies

whose financials are consolidated, other than the regular remuneration payments made by the entities with whom

members of Senior Management Team have their employment contracts.

No loans or guarantees

In the year ended December 31, 2024, no loans were granted to members of our Senior Management Team and Non-

Executive Directors and no guarantees or the like have been granted in favor of any member of Senior Management

Team or the Board of Directors.

Deviations

In the year ended December 31, 2024, the Company did not deviate from the decision-making process for the

implementation of the 2021 Remuneration Policy for the NEOs and Non-Executive Directors and no deviations took

place from the 2021 Remuneration Policy.

Key terms of equity plan applicable to grants in 2024

Stock options granted pursuant to the Equity Incentive Plan shall vest with respect to one third of the shares upon the

first anniversary of the date of grant, with the remaining two thirds vesting in 24 equal monthly installments with the

stock options fully vesting upon the third anniversary of the date of grant, subject, in each case, to the optionee’s

continued status as a service provider. Stock options are exercisable when vested, and in any case not after the stock

option expiration date included in each individual stock option grant, which is 10 years, or in the case of Belgian tax

resident employees, at their election either five years or 10 years from the date of grant.

Each stock option shall be granted with an exercise price equal to the fair market value upon the date of grant and shall

have a term equal to five or 10 years from the date of grant. Optionees may prefer to elect the five-year period as this

may limit their personal tax obligations in respect of the stock option in respect to the jurisdiction where stock options

are taxed at grant, compared to a ten-year stock option. Stock options granted to Belgian tax resident beneficiaries

(including the CEO) are not exercisable prior to the fourth year following the year of the grant. Stock options granted to

Non-Executive Directors vest at once on the third anniversary of the date of grant.

RSUs granted under the Equity Incentive Plan shall vest over a period of four years with respect to one fourth of the

shares upon each anniversary of the date of grant. At the time of vesting, the holder of such RSUs receives shares in the

share capital of the Company for free equal to the number of RSUs vested minus a certain number of shares required to

cover employee taxes payable by us on behalf of the holder of RSUs, if applicable. In 2024, the Equity Incentive Plan

was updated to reflect stakeholder feedback in relation to RSUs granted to Non-Executive Directors. RSUs granted in

2024 to Non-Executive Directors vest after one year instead of four years and are subject to a three-year holding period.


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Unvested equity incentives shall vest in the event of a (i) sale, merger, consolidation, tender offer or similar acquisition

of shares or other transaction or series of related transactions as a result of which a change in control occurs, (ii) sale or

other disposition of all or substantially all of the Company’s assets or (iii) the Company’s dissolution and/or liquidation.

The Board of Directors, upon approval of a majority of the Non-Executive Directors, may amend or terminate the Equity

Incentive Plan or may amend the terms of the Equity Incentive Plan, or any outstanding stock options or RSUs, provided

that the Company will compensate any affected individual for any direct negative impact of such amendment.

We plan to amend the Equity Incentive Plan to reflect the Proposed 2025 Remuneration Policy if it is approved at the

2025 General Meeting.

Peer group selection

We have rapidly evolved and will continue to evolve into a fully integrated immunology company with a strong presence

globally. To thrive and continue building the organization, we need executive and non-executive talent with a deep

understanding of the global market in which we operate. We therefore compete for global talent. This is why we have

established a global peer group focused on six key criteria that reflect the companies we benchmark against in attracting

and retaining top talent.

In connection with the benchmark exercise for 2025 remuneration ahead of setting fixed and variable pay levels, the

following criteria were used for the first time in the third quarter of 2024 to select the new global peer group (the Peer

Group).

Compared to the European and Global peer groups used for the determine of the remuneration until 2024, the 2025 Peer

Group consists of 15 companies. We deem a minimum of 15 companies appropriate, because (i) our industry tends to

evolve quickly, with companies emerging and disappearing (due to mergers or otherwise) relatively often, and (ii) we

deem it relevant to have a certain consistency in the companies comprising our peer group over the longer term.

If there are not 15 companies meeting each of the criteria, we will include in our reference group all companies that meet

the criteria, and supplement with companies that meet all but one criterion. The least relevant criterion will be dropped

first, in the order as displayed below (from most to least relevant).


Selection Criterion in order of relevance		Range of Peers based on Criterion	Relevance of criterion
1.	Sector	Biopharmaceutical companies, excluding diagnostics and animal health companies	Biopharmaceutical companies have characteristic pay and incentive structures compared to other industries. Within the biopharmaceutical industry, excluding diagnostics and animal health companies is appropriate because the talent focus of such companies is different and therefore they are not typically our competitors for talent. In addition, their pay structures tend to differ from those in our industry making these less relevant comparators.
2.	Listing location	Listed on a major US Stock Exchange	Being listed on a major US stock exchange brings additional complexity, expertise requirements and potential liabilities to company officers and directors, which is typically reflected in a different pay structure of executives and board members serving on US listed companies, versus companies without a US listing. Our benchmark exercise shows that having a listing on a major US stock exchange tends to have a more significant relevance for pay structure applied by companies than does location of headquarters, which is why we do not apply a ‘location of headquarters’ filter.


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Selection Criterion in order of relevance		Range of Peers based on Criterion	Relevance of criterion
3.	Innovation focus	At least 25% of revenue is spent on R&D	Innovation focused, R&D driven companies tend to have a typical remuneration structure which differs from companies who focus on commercializing external innovations. To ensure we continue to be able to compete with other innovators, we limit our peer group selection to other companies who continue to significantly invest in their R&D activities.
4.	Global reach	Generates product revenues both within and outside the US	Leading commercial operations both inside and outside the United States puts unique demands on the skills and expertise of key individuals, in addition to the strain of splitting their time and efforts across continents. For this reason, we compare pay practices to other global companies instead of companies with mostly local activities.
5.	Revenue	1/4 – 4x of our annual revenue	We compare ourselves to organizations that also have significant product revenues, as a reflection of overall size and complexity of the organization. Using a relatively wide range for this metric is appropriate to ensure we include relevant peers while ensuring a level of stability in the peer group over time. In setting the range, we also considered the rapid development in our own revenues since our first year of product commercialization (2023) and our internal revenue projections for the immediate future.
6.	Market Cap	1/4 – 4x our market cap (based on 30 day average closing price)	Whereas market cap can give some indication of overall size and complexity of comparator organizations, we also recognize that companies in our sector tend to have volatile stock prices and market cap can vary significantly even throughout a given calendar year.1) Using a relatively wide range for this metric is appropriate to ensure we include relevant peers while ensuring a level of stability in the peer group year-over-year. By going as low as 1/4x our value and as high as 4x our value, we aim to ensure that we are not positioning ourselves on either end of the peer group for this metric, to avoid establishing a peer group that is considered aspirational. Finally, given that market cap is influenced by a range of factors that do not necessarily correlate to the organization’s size or complexity or talent needs, we deem this the least relevant filter. If we are unable to reach our minimum of 15 peer companies meeting all selection criteria, we will include companies who meet all other criteria and are closest to our market cap criterion (but no more than 2x the high end of our range) in order to make up the 15. If we cannot make up to 15 applying this modified filter, we will include companies who are outside of but close to our revenue filter limits.

1) As at March 17, 2025, the delta between our 52-week high and low was approximately 104%, https://

live.euronext.com/nl/product/equities/NL0010832176-XBRU.


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Company Name		Country of Headquarters
Alnylam Pharmaceuticals, Inc.		USA
Amicus Therapeutics, Inc.		USA
Ascendis Pharma A/S		Denmark
BeiGene, Ltd.		Cayman Islands
Biogen Inc.		USA
BioMarin Pharmaceutical Inc.		USA
BioNTech SE		Germany
Blueprint Medicines Corporation		USA
Genmab SE		Denmark
Incyte Corporation		USA
Insmed Inc.		USA
Jazz Pharmaceuticals plc		Ireland
Moderna, Inc.		USA
Sarepta Therapeutics, Inc.		USA
Ultragenyx Pharmaceutical Inc.		USA

Looking Forward

Increased disclosure

During our stakeholder outreach in relation to our proposed 2024 remuneration policy as well as the Proposed 2025

Remuneration Policy, we received feedback that the disclosure on STI and LTI in previous remuneration reports was not

consistent with best practices. Consequently, stakeholders were not able to determine if and how pay-for-performance

was embedded in our remuneration. To address this feedback, in the Proposed 2025 Remuneration Policy we therefore

commit to a more detailed prospective disclosure for both the STI and LTI and retrospective disclosure against a

threshold-target-maximum framework, including actual achievement and corresponding payout.

To showcase our commitment to address stakeholder feedback, this 2024 Remuneration Report contains the prospective

disclosure on the STI and LTI for the Named Executive Officers despite the Proposed 2025 Remuneration Policy not

having been approved yet.

STI

CEO

Distinction

Under the current 2021 Remuneration Policy, the annual STI opportunity for the CEO consists of an at-target

opportunity of 60% of base pay, and a maximum opportunity of 120% of base pay. The Proposed 2025 Remuneration

Policy does not include any change to the current founder CEO’s 2025 STI opportunity. Therefore, for 2025 the STI

opportunity remains equal to 60% of base pay at target and a maximum payout of 120% of base pay.

In order to remain competitive in attracting, motivating and retaining any future Executive Director (including a future

CEO), we target competitive remuneration levels in the Proposed 2025 Remuneration Policy. Therefore, and based on

the Peer Group benchmark data, the annual STI opportunity for a future Executive Director will be up to 100% of base

pay at target and a maximum payout of up to 200% of base pay.

The majority of the targets under the Proposed 2025 Remuneration Policy will be quantitative in nature and at least 50%

of the total STI opportunity for an Executive Director will be linked to financial performance metrics. Qualitative targets

will be milestone-based to the extent possible.

STI

The top priorities identified in 2025 for the CEO include delivering continued VYVGART growth, advancing the

pipeline, further embedding our culture and innovation mission by making it everyone’s business and ensuring business

continuity by having a succession plan in place for senior key leader. The following metrics apply for 2025, which will


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be reported in more detail along with their final assessment and payout as part of the remuneration report on financial

year ended December 31, 2025, to be published in 2026.


Performance metric	Target	Measurement (how the Board of Directors will evaluate the metric and why it has been chosen)	Threshold	Target	Max
Revenue (50%)	Deliver continued VYVGART growth	Annual operating budget revenue target delivered and successful PFS self- administration approval and launch in US	Targets and Executive Director achievement will be disclosed retroactively in the 2025 remuneration report
Revenue (50%)	Deliver continued VYVGART growth
Pipeline (20%)	Advance the pipeline	MG combo clinical trial launched Q3
Pipeline (20%)	Advance the pipeline	Nominate 2 new ARGX-xxx candidates and graduate 3 discovery projects to lead identification (PPD)
Innovation (20%)	Embed our culture and innovation mission	Champion key innovation projects
		All variable pay eligible employees have 1x performance goal linked to innovation
		Key innovations recognized, celebrated and cascaded throughout the Company
Scaling the argenx way (10%)	Talent development	Succession plan in place for key senior leaders

COO

The top priorities identified in 2025 for the COO include delivering continued VYVGART growth growth and leading

digital transformation and scaling the argenx way. The following metrics apply for 2025, which will be reported in more

detail along with their final assessment and payout as part of the remuneration report on financial year ended December

31, 2025, to be published in 2026.


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Performance metric

Target

Measurement (how the

Board of Directors will

evaluate the metric

and why it has been

chosen)

Threshold

Target

Max

Revenue (40%)

Deliver continued

VYVGART growth

Annual operating budget

revenue target delivered

and successful PFS self-

administration approval

and launch in US

Targets and COO achievement will be

disclosed retroactively in the 2025

remuneration report

Pipeline acceleration

(20%)

Not disclosed

Digital transformation

(20%)

Embed our culture and

innovation mission

Successful onboarding

of Business Information

Systems (BIS) leader

and deliver on the BIS

OGSM

Scaling the argenx way

20%)

Talent development

Successful onboarding

of key hires and

leadership teams' their

OGSM

Elevate the operational

excellence community

to a leadership

community and their

OGSM delivered

CFO

The top priorities identified in 2025 for the CFO include delivering continued VYVGART growth, delivering profit and

loss leadership and to further drive productivity. The following metrics apply for 2025, which will be reported in more

detail along with their final assessment and payout as part of the remuneration report on financial year ended December

31, 2025, to be published in 2026.


Performance metric	Target	Measurement (how the Board of Directors will evaluate the metric and why it has been chosen)	Threshold	Target	Max
Revenue (30%)	Deliver continued VYVGART growth	Annual operating budget revenue target delivered and successful PFS self- administration approval and launch in US	Targets and CFO achievement will be disclosed retroactively in the 2025 remuneration report
Revenue (30%)	Deliver continued VYVGART growth
P&L (25%)	Financial performance	Target effective tax rate in 2025 in line with annual operating budget
Digital transformation (25%)	Internal financial systems	Time required to close the quarter reduced by
		Annual operating budget process transformation
		Financial accounts automation
Scaling the argenx way (20%)	Strategic organizational growth	Management headcount growth


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LTI

PSU

During our stakeholder outreach in relation to our proposed 2024 remuneration policy, the vast majority of the feedback

we received on the introduction of PSUs was positive. This was confirmed in the outreach relating to the Proposed 2025

Remuneration Policy. Irrespective of the Proposed 2025 Remuneration Policy being approved at 2025 General Meeting,

we will introduce PSUs. The LTI grant will therefore consist of 50% stock options and 50% PSUs.

PSUs are granted on the last business day of June, i.e., on June 30 in 2025. PSUs have a 3-year performance period and

in 2025 will therefore cover the period between January 1, 2025 and December 31, 2027. PSUs will have a 3-year cliff

vest. The performance metrics will be challenging long-term goals essential for the Company’s success and will be set

within the following framework:

•at least 50% of the pay opportunity will be linked to financial performance metrics such as revenue growth;

•at least 40% of the pay opportunity will be linked to innovation and pipeline development metrics, such as delivering

clinical and regulatory milestones; and

•up to 10% of the pay opportunity will be linked to people and culture metrics essential for sustainable, long-term

value creation.

The grant value of the PSUs will be determined after publication of this Annual Report on June 30, 2025, in accordance

with the determination methodology described under “Item 6.B. — Compensation — Total Named Executive Officer

Remuneration — Equity” above. Further details on the PSU grant will be included in the 2025 remuneration report, to be

published in 2026.

2025 PSU grant performance metrics

The below performance metrics will apply to the 2025 PSU grant for all Named Executive Officers and all others

members of Senior Management Team.


Performance Metric	Target	Measurement (how the Board of Directors will evaluate the metric and why it has been chosen)	Threshold	Target	Max
Maximize the VYVGART opportunity (65%)	2027 annual revenue (50%)	Minimum product net sales of undisclosed amount	Targets and Executive Director achievement will be disclosed retroactively in the 2027 remuneration report, published in 2028
Build a portfolio of breakthrough antibody- based products (15%)	gMG Label Expansion (15%)	Seronegative gMG and ocular gMG approved by the FDA
	FDA submissions (15%)	Undisclosed number of indications approved or submitted to the FDA
Ensure long-term sustainability as an independent company (10%)	Pipeline progression (10%)	Undisclosed number of pipeline assets into phase 2 and/or undisclosed number of additional pipeline assets IND / clinical trial application submitted
Scaling the argenx way (10%)	Talent retention (10%)	Three-year average voluntary employee turnover equal to or


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Summary of Named Executive Officer Remuneration

Total remuneration Named Executive Officers

The following table sets forth the total value of the remuneration paid to the NEOs for the last three years:


(in $)	Base pay 1)	Base pay in % change vs the prior year 1)	Sign on bonus	Corporate bonus	Variable short-term incentive	Variable cash as % of maximum opportunity	Compensati on in the form of stock options 2)	Compensati on in the form of RSUs	Other benefits 3)	% fixed (of total) 4)	Total
CEO - Tim Van Hauwermeiren
2024	757,680	15%	—	—	795,563	60%	3,194,813	3,014,500	45,230	10%	7,807,786
2023	655,787	—%	—	—	590,215	60%	8,084,605 5)	2,575,174	39,054	6%	11,944,835
2022	638,901	10%	—	—	766,682	60%	4,174,684	2,159,689	38,342	9%	7,778,298
COO - Karen Massey 6)
2024	655,657	37%	—	3,636	573,593	50%	2,018,973	2,100,610	842,014	24%	6,194,483
2023	481,471	N/A	338,000 7)	2,921	467,662	50%	3,939,093	2,296,517	127,393	8%	7,653,057
CFO - Karl Gubitz
2024	553,000	7%	—	3,636	331,800	40%	2,018,973	2,100,610	260,571	15%	5,268,590
2023	516,043	6%	—	3,556	260,866	40%	2,626,062	1,287,587	62,798	12%	4,756,913
2022	487,600	79%	—	3,745	243,800	40%	2,623,633	1,356,048	91,203	12%	4,806,030
COO - Keith Woods 8)
2023	305,022	(48)%	—	—	—	—	—	—	46,034	100%	351,056
2022	583,774	5%	—	3,745	583,774	50%	2,601,982	1,364,014	205,032	15%	5,342,321

1)The base pay of the CEO is paid in EUR (for 2024 the base pay exchange rate used in this table is 1.0824 EUR/USD ), the base pay of the COO is paid in CHF (for 2024 the base pay exchange rate used

in this table is 1.1363 CHF/USD). The base pay of the CFO is paid in USD. The percentage presenting the change in base pay is calculated using the currency of payment.

2)Amounts shown represent the expenses with respect to stock options measured using the Black-Scholes model. For a description of the assumptions used in valuing these awards, see “Note 13 — Share-

Based Payments” to our Consolidated Financial Statements which are appended to our Annual Report for the period ended December 31, 2024 and which are incorporated herein by reference.

3)Other benefits consists of the lease of a company car, employer-paid medical insurance premiums, pension contributions, social security costs and other allowances. In 2024, employer social security

costs were impacted by the increase of share-price at year end against the share-price as of December 31, 2023.

4)Fixed compensation is considered as base pay and other benefits.

5)Based on the approved 2024 equity allocation scheme, the total equity target value for Tim Van Hauwermeiren is equal to $5,080,000 and the total equity target value for Karen Massey and Karl Gubitz

is equal to $3,040,000 for each. The CEO, COO and CFO received their respective equity grants at target value converted into a number of stock options and RSUs on the Reference Date of the 30-days

average share price of $375.68 per share preceding the Reference Date and the Black-Scholes model fair market value of $138.96 per stock option. This results in the number of stock options and RSUs

shown above. The amounts shown above represent the actual value received at the grant date of June 28, 2024 at which date the Company’s share price was equal to $445.76. The difference of $70.08

per share is explained by the stock price increase in the intervening period primarily due to approval of VYVGART HYTRULO for CIDP in the U.S. by the FDA. For more information on the CEO

equity grant, please refer to “Item 6. B. — Compensation — Equity — Determination of target value of CEO equity grant” above. The fair market value based on the Black-Scholes model for Tim Van

Hauwermeiren is $174.78 and the fair market value for the COO and CFO is $158.50. These amounts do not reflect the actual economic value realized by the beneficiary. Amounts shown represent the

expenses with respect to the stock options awards granted in 2024 measured using the Black-Scholes model with unobservable assumptions. The assumptions used in the fair valuation differ between

Belgian beneficiary versus non-Belgian beneficiary. For a description of the assumptions used in valuing these awards, see “Note 13 Share-Based Payments“ to our Consolidated Financial Statements

which are appended to our Annual Report for the period ended December 31, 2024 and which are incorporated herein by reference.

6)Karen Massey joined as COO in March 2023, and consequently no comparison to 2022 is available. Ms. Massey’s remuneration shows the remuneration paid for the period March 13, 2023 through

December 31, 2023. Her 2023 variable pay pay-out has been pro-rated to reflect this as well. The increase year over year for 2024 is not representative as it is comparing to a partial work year.


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7)In 2023, the Company paid a sign-on bonus to Karen Massey to allow the Company to make an overall competitive offer of employment and in recognition of lost corporate benefits as a result of early

departure at Ms. Massey’s previous employer. Ensuring a competitive offer in this way and securing Ms. Massey as the Company’s new COO was deemed by the Board of Directors to be in the best

interest of the Company and its stakeholders.

8)Keith Woods resigned as COO March 2023 and his employment relationship ended on June 30, 2023 and consequently the remuneration numbers show his remuneration for the period January 1, 2023

through June 30, 2023. No equity award or variable pay was paid to Mr. Woods in the year ended December 31, 2023.

Stock option overview Named Executive Officers

The table below shows (i) the stock options held as of January 1, 2024, (ii) the stock options granted to the NEOs which vested during the year ended December 31,

2024, (iii) the number of stock options scheduled to vest in the years ending December 31, 2025, December 31, 2026 and December 31, 2027 and (iv) the respective

exercise price of such stock options. Each stock option was granted pursuant to the Equity Incentive Plan:


								Information regarding the reported financial year
								Opening Balance	During the Year				Closing balance
Name of Directors, Position	Specification plan	Performance Period	Award Date	Vesting date	End of retention period	Exercise Period	Exercise price of stock option (€)	Stock options held at the beginning of the period	Stock options awarded	Stock options exercised	Stock options forfeited	Stock options vested	Stock options subjected to a service period	Stock options awarded and unvested	Stock options held at the end of the year		Stock options subjected to a retention period
Tim Van Hauwermeiren, CEO	Equity incentive plan	21/12/2018 - 01/12/2021	21/12/2018	(1)	31/12/2021	01/01/2022 - 21/12/2028	86.32	80,000	—	—	—	—	—	—	80,000		—
		20/12/2019 - 01/12/2022	20/12/2019	(1)	31/12/2022	01/01/2023 - 20/12/2029	135.75	80,000	—	—	—	—	—	—	80,000		—
		21/12/2020 - 01/12/2023	21/12/2020	(1)	31/12/2023	01/01/2024 - 21/12/2030	247.60	50,000	—	—	—	—	—	—	50,000		—
		24/12/2021 - 01/12/2024	24/12/2021	(1)	31/12/2024	01/01/2025 - 24/12/2031	309.20	25,000	—	—	—	8,333	—	—	25,000		—
		23/12/2022 - 01/12/2025	23/12/2022	(1)	31/12/2025	01/01/2026 - 23/12/2032	359.60	25,000	—	—	—	8,334	8,333	8,333	25,000		25,000
		03/07/2023 - 01/07/2026	03/07/2023	(1)	31/12/2026	01/01/2027 - 03/07/2033	355.40	30,000	—	—	—	14,167	15,833	15,833	30,000		30,000
		28/06/2024 - 01/06/2027	28/06/2024	(1)	31/12/2027	01/01/2028 - 28/06/2034	416.40	—	18,279	—	—	—	18,279	18,279	18,279		18,279
Total								290,000	18,279	—	—	30,834	42,445	42,445	308,279		73,279

Karen Massey, COO	Equity incentive plan	03/07/2023 - 01/07/2026	03/07/2023	(1)	N/A	03/07/2024 - 03/07/2033	355.40	22,500	0	—	—	10,625	11,875	11,875	22,500		—
		28/06/2024 - 01/06/2027	28/06/2024	(1)	N/A	28/06/2025 - 28/06/2034	416.40	—	12,738	—	—	—	12,738	12,738	12,738		—
Total								22,500	12,738	—	—	10,625	24,613	24,613	35,238	3 5 , 2 3 8	—

Karl Gubitz, CFO	Equity incentive plan	01/07/2021 - 01/07/2024	01/07/2021	(1)	N/A	01/07/2022 - 01/07/2031	255.10	24,000	—	—	—	4,667	—	—	24,000		—
		01/07/2022 - 01/07/2025	01/07/2022	(1)	N/A	01/07/2023 - 01/07/2032	357.50	16,000	—	—	—	5,333	3,111	3,111	16,000		—
		03/07/2023 - 01/07/2026	07/03/2023	(1)	N/A	03/07/2024 - 03/07/2033	355.40	15,000	—	—	—	7,083	7,917	7,917	15,000		—
		28/06/2024 - 01/06/2027	28/06/2024	(1)	N/A	28/06/2025 - 28/06/2034	416.40	—	12,738	—	—		12,738	12,738	12,738		—
Total								55,000	12,738	—	—	17,083	23,766	23,766	67,738		—

1)1/3rd of the stock options vests on the first anniversary of the date of grant and the remaining 2/3rd vest in equal installments (24 in total) over the next two years, each time upon the 1st day of each next

month.


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RSU overview Named Executive Officers

The table below shows (i) the RSUs held as of January 1, 2024, (ii) the RSUs granted to the NEOs which vested during the year ended December 31, 2024 and (iii)

the number of RSUs scheduled to vest in the years ending December 31, 2025, December 31, 2026, December 31, 2027 and December 31, 2028. Each RSU was

granted pursuant to the Equity Incentive Plan:


					Information regarding the reported financial year
					Opening balance	During the Year			Closing balance
Name of Directors, Position	Vesting period	Award Date	Vesting date	End of retention period	RSUs held at the beginning of the year	RSUs awarded	RSU Forfeited	RSUs vested	RSUs subject to a service condition	RSUs awarded and unvested	RSUs held at the closing of the year	RSUs subject to a retention period
Tim van Hauwermeiren, CEO	24/12/2021 - 24/12/2025	24/12/2021	(1)	N/A	2,850	—	—	1,425	—	1,425	1,425	—
	23/12/2022 - 23/12/2026	23/12/2022	(1)	N/A	4,275	—	—	1,425	—	2,850	2,850	—
	03/07/2023 - 03/07/2027	07/03/2023	(1)	N/A	6,700	—	—	1,675	—	5,025	5,025	—
	28/06/2024 - 28/06/2028	28/06/2024	(1)	N/A	—	6,762	—		—	6,762	6,762	—
Total					13,825	6,762	—	4,525	—	16,062	16,062	—

Karen Massey, COO	03/07/2023 - 03/07/2027	03/07/2023	(1)	N/A	5,025	—	—	1,256	—	3,769	3,769	—
Karen Massey, COO	28/06/2024 - 28/06/2028	28/06/2024	(1)	N/A	—	4,712	—	—	—	4,712	4,712	—
Total					5,025	4,712	—	1,256	—	8,481	8,481	—

Karl Gubitz, CFO	01/07/2021 - 01/07/2025	01/07/2021	(1)	N/A	2,700	—	—	1,350	—	1,350	1,350	—
	01/07/2022 - 01/07/2026	01/07/2022	(1)	N/A	2,700	—	—	900	—	1,800	1,800	—
	03/07/2023 - 03/07/2027	07/03/2023	(1)	N/A	3,350	—	—	837	—	2,513	2,513	—
	28/06/2024 - 28/06/2028	28/06/2024	(1)	N/A	—	4,712	—	—	—	4,712	4,712	—
Total					8,750	4,712	—	3,087	—	10,375	10,375	—

1)RSUs vest over a period of four years with 1/4th of the total grant vesting at each anniversary of the date of grant.


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Summary of other members of the Senior Management Team

Stock options overview other members of the Senior Management Team

The following table sets forth information regarding stock option and RSU awards granted to members of the Senior Management Team during the year ended

December 31, 2024:


	RSUs granted in 2024				Stock options granted in 2024
Name	# RSUs	Key terms	Value at grant in $		# Stock options	Exercise price in €		Exercise price in $		Key terms	Value at grant in $ 1)		Total
Peter Ulrichts	4,712	RSUs vest and are settled in 4 equal installments of 25% over a 4 year period.		2,100,421.12	12,738		416.40		445.76	1/3 vests after year 1 2/3 vest in monthly installments in year 2 and 3.	2,740,705	$	4,841,126
Malini Moorthy	4,712			2,100,421.12	12,738		416.40		445.76		2,018,973		4,119,394
Luc Truyen	4,712			2,100,421.12	12,738		416.40		445.76		2,250,490		4,350,911
Arjen Lemmen	4,712			2,100,421.12	12,738		416.40		445.76		2,740,705		4,841,126
Andria Wilk	1,331			593,306.56	3,599		416.40		445.76		774,360		1,367,667

1.These amounts do not reflect the actual economic value realized by the beneficiary. Amounts shown represent the expenses with respect to the Stock options awards granted in 2024 measured

using the Black-Scholes model with unobservable assumptions. The assumptions used in the fair valuation differ between Belgian beneficiary versus non-Belgian beneficiary. The fair value of

Belgian beneficiary was higher than non-Belgian beneficiary resulting in stock based compensation expense to be higher for Belgian beneficiaries than other beneficiaries. For a description of the

assumptions used in valuing these awards, see “Note 13 Share-Based Payments in our consolidated financial statements which are appended to our Annual report for the period ended

December 31, 2024 and which are incorporated herein by reference.


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The table below shows (i) the stock options held as of January 1, 2024, (ii) the stock options granted to members of Senior Management Team (other than the NEOs)

which vested during the year ended December 31, 2024, (iii) the number of stock options scheduled to vest in the years ending December 31, 2025, December 31,

2026 and December 31, 2027 and (iv) the respective exercise price of such stock options. Each stock option was granted pursuant to the Equity Incentive Plan:


								Information regarding the reported financial year
								Opening balance	During the Year				Closing balance
Name of Directors, Position	Specification plan	Performance period	Award date	Vesting date	End of retention period	Exercise period	Exercise price of stock option in €	Stock options held at the beginning of the year	Stock options awarded	Stock options exercised	Stock options forfeited	Stock options vested	Stock options subject to a service condition	Stock options awarded and unvested	Stock options held at the end of the year	Stock options subject to a retention period
Peter Ulrichts, CSO	Equity incentive plan	20/12/2019 - 01/12/2022	20/12/ 2019	(1)	31/12/ 2022	01/01/2023 - 20/12/2029	135.75	5,000	—	1,000	—	—	—	—	4,000	—
		21/12/2020 - 01/12/2023	21/12/ 2020	(1)	31/12/ 2023	01/01/2024 - 21/12/2030	247.60	9,900	—	2,249	—	—	—	—	7,651	—
		24/12/2021 - 01/12/2024	24/12/ 2021	(1)	31/12/ 2024	01/01/2025 - 24/12/2026	309.20	3,420	—	—	—	1,140	—	—	3,420	—
		23/12/2022 - 01/12/2025	23/12/ 2022	(1)	31/12/ 2025	01/01/2026 - 23/12/2027	359.60	16,000	—	—	—	3,812	3,811	3,811	16,000	16,000
		03/07/2023 - 01/07/2026	03/07/ 2023	(1)	31/12/ 2026	01/01/2027 - 03/07/2028	355.40	15,000	—	—	—	7,083	7,917	7,917	15,000	15,000
		28/06/2024 - 01/06/2027	28/06/ 2024	(1)	31/12/ 2027	01/01/2028 - 28/06/2034	416.40	—	12,738	—	—	2,782	9,956	9,956	12,738	12,738
Total								49,320	12,738	3,249	—	14,817	21,684	21,684	58,809	43,738

Malini Moorthy, Legal Counsel	Equity incentive plan	01/04/2022 - 01/04/2025	01/04/2022	(1)	N/A	01/04/2023 - 01/04/2032	282.50	16,500	—	10,000	—	8,000	2,667	2,667	6,500	—
		03/07/2023 - 01/07/2026	03/07/2023	(1)	N/A	03/07/2024 - 03/07/2033	355.40	15,000	—	—	—	7,083	7,917	7,917	15,000	—
		28/06/2024 - 01/06/2027	28/06/2024	(1)	N/A	01/01/2028 - 28/06/2034	416.40	—	12,738	—	—	0	12,738	12,738	12,738	—
Total								31,500	12,738	10,000	—	15,083	23,322	23,322	34,238	—

Luc Truyen, CMO	Equity incentive plan	01/10/2021 - 01/10/2024	01/10/2021	(1)	31/12/2024	01/01/2025 - 01/10/2026	259.5	24,000	—	—	—	6,667	—	—	24,000	—
		23/12/2022 - 01/12/2025	23/12/2022	(1)	31/12/2025	01/01/2026 - 23/12/2027	359.6	16,000	—	—	—	5,334	5,333	5,333	16,000	16,000
		03/07/2023 - 01/07/2026	03/07/2023	(1)	31/12/2026	01/01/2027 - 03/07/2028	355.4	15,000	—	—	—	7,083	7,917	7,917	15,000	15,000
		28/06/2024 - 01/06/2027	28/06/2024	(1)	31/12/2027	01/01/2028 - 28/06/2034	416.4	—	12,738	—	—	—	12,738	12,738	12,738	12,738
Total								55,000	12,738	—	—	19,084	25,988	25,988	67,738	43,738


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								Information regarding the reported financial year
								Opening balance	During the Year				Closing balance
Name of Directors, Position	Specification plan	Performance period	Award date	Vesting date	End of retention period	Exercise period	Exercise price of stock option in €	Stock options held at the beginning of the year	Stock options awarded	Stock options exercised	Stock options forfeited	Stock options vested	Stock options subject to a service condition	Stock options awarded and unvested	Stock options held at the end of the year	Stock options subject to a retention period
Arjen Lemmen, Vice President of Corporate Development & Strategy	Equity incentive plan	28/06/2018 - 01/06/2021	28/06/2018	(1)	31/12/2021	01/01/2022 - 28/06/2028	80.82	695	—	695	—	—	—	—	—	—
		21/12/2018 - 01/12/2021	21/12/2018	(1)	31/12/2021	01/01/2022 - 21/12/2028	86.32	15,952	—	15,952	—	—	—	—	—	—
		20/12/2019 - 01/12/2022	20/12/2019	(1)	31/12/2022	01/01/2023 - 20/12/2029	135.75	37,555	—	37,555	—	—	—	—	—	—
		21/12/2020 - 01/12/2023	21/12/2020	(1)	31/12/2023	01/01/2024 - 21/12/2030	247.60	50,000	—	2,326	—	—	—	—	47,674	—
		24/12/2021 - 01/12/2024	24/12/2021	(1)	31/12/2024	01/01/2025 - 24/12/2031	309.20	16,000	—	—	—	5,333	—	—	16,000	—
		23/12/2022 - 01/12/2025	23/12/2022	(1)	N/A	23/12/2023 - 23/12/2032	359.60	16,000	—	—	—	5,333	5,333	5,333	16,000	—
		03/07/2023 - 01/07/2026	03/07/2023	(1)	N/A	03/07/2024 - 03/07/2033	355.40	15,000	—	—	—	7,084	7,917	7,917	15,000	—
		28/06/2024 - 01/06/2027	28/06/2024	(1)	31/12/2027	01/01/2028 - 28/06/2034	416.40	—	12,738	—	—	0	12,738	12,738	12,738	12,738
Total								151,202	12,738	56,528	—	17,750	25,988	25,988	107,412	12,738
Andria Wilk, Global Head of Quality	Equity incentive plan	21/12/2020 - 01/12/2023	21/12/2020	(1)	31/12/2023	01/01/2024 - 21/12/2025	247.60	9,900	—	9,813	—	—	—	—	87	—
		24/12/2021 - 01/12/2024	24/12/2021	(1)	31/12/2024	01/01/2025 - 24/12/2031	309.20	4,446	—	—	—	756	—	—	4,446	—
		23/12/2022 - 01/12/2025	23/12/2022	(1)	31/12/2025	01/01/2026 - 23/12/2027	359.60	4,600	—	—	—	1,127	1,032	1,032	4,600	4,600
		03/07/2023 - 01/07/2026	03/07/2023	(1)	31/12/2026	01/01/2027 - 03/07/2033	355.40	4,600	—	—	—	1,809	1,915	1,915	4,600	3,830
		28/06/2024 - 01/06/2027	28/06/2024	(1)	31/12/2027	01/01/2028 - 28/06/2034	416.40	—	3,599	—	—	786	2,813	2,813	3,599	2,813
Total								23,546	3,599	9,813	—	4,478	5,760	5,760	17,332	11,243

month.

RSU overview other members of the Senior Management Team

The table below shows (i) the RSUs held as of January 1, 2024, (ii) the RSUs granted to members of Senior Management Team (other than the NEOs) which vested

during the year ended December 31, 2024 and (iii) the number of RSUs scheduled to vest in the years ending December 31, 2025, December 31, 2026, December 31,

2027 and December 31, 2028. Each RSU was granted pursuant to the Equity Incentive Plan:


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					Information regarding the reported financial year
					Opening balance	During the Year			Closing balance
Name of Directors, Position	Vesting period	Award date	Vesting date	End of retention period	RSU’s held at the beginning of the year	RSUs awarded	RSUs forfeited	RSUs vested	RSUs subject to a service condition	RSUs awarded and unvested	RSUs held at the closing of the year	RSUs subject to a retention period
Peter Ulrichts, CSO	24/12/2021 - 24/12/2025	12/24/2021	(1)	N/A	380	—	—	190	—	190	190
	23/12/2022 - 23/12/2026	12/23/2022	(1)	N/A	2,700	—	—	900	—	1,800	1,800	—
	03/07/2023 - 03/07/2027	7/3/2023	(1)	N/A	3,350	—	—	837	—	2,513	2,513	—
	28/06/2024 - 27/06/2028	6/28/2024	(1)	N/A	—	4,712	—	—	—	4,712	4,712	—
Total					6,430	4,712	—	1,927	—	9,215	9,215	—

Malini Moorthy, General Counsel	01/04/2022 - 01/04/2026	4/1/2022	(1)	N/A	4,050	—	—	1,350	—	2,700	2,700	—
	03/07/2023 - 03/07/2027	7/3/2023	(1)	N/A	3,350	—	—	837	—	2,513	2,513	—
	28/06/2024 - 27/06/2028	6/28/2024	(1)	N/A	—	4,712	—	—	—	4,712	4,712	—
Total					7,400	4,712	—	2,187	—	9,925	9,925	—

Luc Truyen, CMO	01/10/2021 - 01/10/2025	10/1/2021	(1)	N/A	2,700	—	—	1,350	—	1,350	1,350	—
	23/12/2022 - 23/12/2026	12/23/2022	(1)	N/A	2,700	—	—	900	—	1,800	1,800	—
	03/07/2023 - 03/07/2027	7/3/2023	(1)	N/A	3,350	—	—	837	—	2,513	2,513	—
	28/06/2024 - 27/06/2028	6/28/2024	(1)	N/A	—	4,712	—	—	—	4,712	4,712	—
Total					8,750	4,712	—	3,087	—	10,375	10,375	—

Arjen Lemmen, Vice President of Corporate Development & Strategy	24/12/2021 - 24/12/2025	12/24/2021	(1)	N/A	1,800	—	—	900	—	900	900	—
	23/12/2022 - 23/12/2026	12/23/2022	(1)	N/A	2,700	—	—	900	—	1,800	1,800	—
	03/07/2023 - 03/07/2027	7/3/2023	(1)	N/A	3,350	—	—	837	—	2,513	2,513	—
	28/06/2024 - 27/06/2028	6/28/2024	(1)	N/A	—	4,712	—	—	—	4,712	4,712	—
Total					7,850	4,712	—	2,637	—	9,925	9,925	—

Andria Wilk, Global Head of Quality	24/12/2021 - 24/12/2025	12/24/2021	(1)	N/A	494	—	—	247	—	247	247	—
	23/12/2022 - 23/12/2026	12/23/2022	(1)	N/A	750	—	—	250	—	500	500	—
	03/07/2023 - 03/07/2027	7/3/2023	(1)	N/A	1,000	—	—	250	—	750	750	—
	28/06/2024 - 27/06/2028	6/28/2024	(1)	N/A	—	1,331	—	—	—	1,331	1,331	—
Total					2,244	1,331	—	747	—	2,828	2,828	—

1)RSUs vest over a period of four years with 1/4th of the total grant vesting at each anniversary of the date of grant.


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Summary of Non-Executive Director Equity compensation

Stock Option overview Non-Executive Directors

The table below shows (i) the stock options held at January 1, 2024, (ii) the stock options granted to the Non-Executive Directors which have vested during the year

ended December 31, 2024, (iii) the number of stock options scheduled to vest in the years ending December 31, 2025 and December 31, 2026 and (iv) the respective

exercise price of such stock options. No stock options were granted in 2024 to Non-Executive Directors and consequently Dr. Brian Kotzin does not hold any stock

options and is as such not included in the below table.


							Information regarding the reported financial year
							Opening balance	During the Year			Closing balance
Name of Directors	Performance period	Award date	Vesting date	End of retention period	Exercise period	Grant price in €	Stock options held at the beginning of the year	Stock options awarded	Stock options exercised	Stock options vested	Stock options subject to a service condition	Stock options awarded and unvested	Stock options held at the end of the year	Stock options subject to a retention period
Mr. Peter Verhaeghe	18/12/2014 - 18/12/2017	12/18/2014	(1)	12/31/2017	01/01/2018 - 18/12/2024	7.17	2,000	—	2,000	—	—	—	—	—
	18/06/2016 - 18/06/2019	6/18/2016	(1)	12/31/2019	01/01/2020 - 18/06/2026	11.38	10,000	—	6,000	—	—	—	4,000	—
	21/12/2018 - 21/12/2021	12/21/2018	(1)	12/31/2021	01/01/2022 - 21/12/2028	86.32	10,000	—	—	—	—	—	10,000	—
	20/12/2019 - 20/12/2022	12/20/2019	(1)	12/31/2022	01/01/2023 - 20/12/2029	135.75	10,000	—	—	—	—	—	10,000	—
	21/12/2020 - 21/12/2023	12/21/2020	(1)	12/31/2023	01/01/2024 - 21/12/2030	247.60	10,000	—	—	—	—	—	10,000	—
	24/12/2021 - 24/12/2024	12/24/2021	(2)	12/31/2024	01/01/2025 - 24/12/2031	309.20	2,700	—	—	2,700	—	—	2,700	—
	23/12/2022 - 23/12/2025	12/23/2022	(2)	12/31/2025	01/01/2026 - 23/12/2032	359.60	2,700	—	—	—	—	2,700	2,700	2,700
	03/07/2023 - 03/07/2026	7/3/2023	(2)	12/31/2026	01/01/2027 - 03/07/2033	355.40	1,600	—	—	—	—	1,600	1,600	1,600
Total							49,000	0	8,000	2,700	—	4,300	41,000	4,300

Mr. Steve Krognes	03/04/2023 - 03/04/2026	4/3/2023	(2)	12/31/2026	03/04/2024 - 03/04/2033	340.70	2,400	0				2,400	2,400	2,400
Total							2,400	—	—	—	—	2,400	2,400	2,400


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							Information regarding the reported financial year
							Opening balance	During the Year			Closing balance
Name of Directors	Performance period	Award date	Vesting date	End of retention period	Exercise period	Grant price in €	Stock options held at the beginning of the year	Stock options awarded	Stock options exercised	Stock options vested	Stock options subject to a service condition	Stock options awarded and unvested	Stock options held at the end of the year	Stock options subject to a retention period
Dr. Pamela Klein	21/12/2018 - 21/12/2021	12/21/2018	(1)	N/A	21/12/2019 - 21/12/2028	86.32	1,500	—	1,500	—	—	—	—	—
	20/12/2019 - 20/12/2022	12/20/2019	(1)	N/A	20/12/2020 - 20/12/2029	135.75	10,000	—	2,500	—	—	—	7,500	—
	21/12/2020 - 21/12/2023	12/21/2020	(1)	N/A	21/12/2021 - 21/12/2030	247.60	10,000	—	—	—	—	—	10,000	—
	24/12/2021 - 24/12/2024	12/24/2021	(2)	12/31/2024	24/12/2022 - 24/12/2031	309.20	2,700	—	—	2,700	—	—	2,700	—
	23/12/2022 - 23/12/2025	12/23/2022	(2)	12/31/2025	23/12/2023 - 23/12/2032	359.60	2,700	—	—	—	—	2,700	2,700	2,700
	03/07/2023 - 03/07/2026	7/3/2023	(2)	12/31/2026	03/07/2024 - 03/07/2033	355.40	1,600	—	—	—	—	1,600	1,600	1,600
Total							28,500	—	4,000	2,700	—	4,300	24,500	4,300

Dr. Donald deBethizy	18/06/2016 - 18/06/2019	6/18/2016	(1)	N/A	18/06/2017 - 18/06/2026	11.38	10,000	—	—	—	—	—	10,000	—
	21/12/2018 - 21/12/2021	12/21/2018	(1)	N/A	21/12/2019 - 21/12/2028	86.32	10,000	—	—	—	—	—	10,000	—
	20/12/2019 - 20/12/2022	12/20/2019	(1)	N/A	20/12/2020 - 20/12/2029	135.75	10,000	—	—	—	—	—	10,000	—
	21/12/2020 - 21/12/2023	12/21/2020	(1)	N/A	21/12/2021 - 21/12/2030	247.60	10,000	—	—	—	—	—	10,000	—
	24/12/2021 - 24/12/2024	12/24/2021	(2)	12/31/2024	24/12/2022 - 24/12/2031	309.20	2,700	—	—	2,700	—	—	2,700	—
	23/12/2022 - 23/12/2025	12/23/2022	(2)	12/31/2025	23/12/2023 - 23/12/2032	359.60	2,700	—	—	—	—	2,700	2,700	2,700
	03/07/2023 - 03/07/2026	7/3/2023	(2)	12/31/2026	03/07/2024 - 03/07/2033	355.40	1,600	—	—	—	—	1,600	1,600	1,600
Total							47,000	—	—	2,700	—	4,300	47,000	4,300


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							Information regarding the reported financial year
							Opening balance	During the Year			Closing balance
Name of Directors	Performance period	Award date	Vesting date	End of retention period	Exercise period	Grant price in €	Stock options held at the beginning of the year	Stock options awarded	Stock options exercised	Stock options vested	Stock options subject to a service condition	Stock options awarded and unvested	Stock options held at the end of the year	Stock options subject to a retention period
Anthony Rosenberg	13/12/2016 - 13/12/2019	12/13/2016	(1)	N/A	13/12/2017 - 13/12/2026	14.13	15,000	—	7,200	—	—	—	7,800	—
	21/12/2018 - 21/12/2021	12/21/2018	(1)	N/A	21/12/2019 - 21/12/2028	86.32	10,000	—	—	—	—	—	10,000	—
	20/12/2019 - 20/12/2022	12/20/2019	(1)	N/A	20/12/2020 - 20/12/2029	135.75	8,840	—	—	—	—	—	8,840	—
	21/12/2020 - 21/12/2023	12/21/2020	(1)	N/A	21/12/2021 - 21/12/2030	247.60	3,640	—	—	—	—	—	3,640	—
	24/12/2021 - 24/12/2024	12/24/2021	(2)	12/31/2024	24/12/2022 - 24/12/2031	309.20	2,700	—	—	2,700	—	—	2,700	—
	23/12/2022 - 23/12/2025	12/23/2022	(2)	12/31/2025	23/12/2023 - 23/12/2032	359.60	2,700	—	—	—	—	2,700	2,700	2,700
	03/07/2023 - 03/07/2026	7/3/2023	(2)	12/31/2026	03/07/2024 - 03/07/2033	355.40	1,600	—	—	—	—	1,600	1,600	1,600
Total							44,480	—	7,200	2,700	—	4,300	37,280	4,300

James Daly	21/12/2020 - 21/12/2023	12/21/2020	(1)	N/A	21/12/2021 - 21/12/2030	247.60	10,000	—	—	—	—	—	10,000	—
	24/12/2021 - 24/12/2024	12/24/2021	(2)	12/31/2024	24/12/2022 - 24/12/2031	309.20	2,700	—	—	2,700	—	—	2,700	—
	23/12/2022 - 23/12/2025	12/23/2022	(2)	12/31/2025	23/12/2023 - 23/12/2032	359.60	2,700	—	—	—	—	2,700	2,700	2,700
	03/07/2023 - 03/07/2026	7/3/2023	(2)	12/31/2026	03/07/2024 - 03/07/2033	355.40	1,600	—	—	—	—	1,600	1,600	1,600
Total							17,000	—	—	2,700	—	4,300	17,000	4,300

Camilla Sylvest	03/10/2022 - 03/10/2025	10/3/2022	(2)	12/31/2025	03/10/2023 - 03/10/2032	368.50	4,050	—	—	—	—	4,050	4,050	4,050
Camilla Sylvest	03/07/2023 - 03/07/2026	7/3/2023	(2)	12/31/2026	03/07/2024 - 03/07/2033	355.40	1,200	—	—	—	—	1,200	1,200	1,200
Total							5,250	—	—	—	—	5,250	5,250	5,250

Dr. Ana Cespedes	23/12/2022 - 23/12/2025	12/23/2022	(2)	12/31/2025	23/12/2023 - 23/12/2032	359.60	4,050	—	—	—	—	4,050	4,050	4,050
Dr. Ana Cespedes	03/07/2023 - 03/07/2026	7/3/2023	(2)	12/31/2026	03/07/2024 - 03/07/2033	355.40	800	—	—	—	—	800	800	800
Total							4,850	—	—	—	—	4,850	4,850	4,850


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1)1/3rd of the stock options vests on the first anniversary of the date of grant and the remaining 2/3rd vest in equal monthly installments (24 in total) over the next two years, each time upon the 1st day of

each next month.

2)Stock options vest upon third anniversary of the grant.

RSU overview Non-Executive Directors

The table below shows (i) the RSUs held at January 1, 2024, (ii) the RSUs granted to the Non-Executive Directors which have vested during the year ended

December 31, 2024 and (iii) RSUs scheduled to vest in the years ending December 31, 2025, December 31, 2026 and December 31, 2027 (in number of RSUs).

RSUs granted to Non-Executive Directors before 2024 vest over a period of four years with 1/4th of the total grant vesting at each anniversary of the grant date. RSUs

granted to Non-Executive Directors in 2024 will all vest on the 1st anniversary of the grant date in 2025 and are subject to a holding period of 3 years.


					Information regarding the reported financial year
					Opening balance	During the Year		Closing balance
Name of member of Board of Directors	Vesting period	Award date	Vesting date	End of holding period	RSUs held at the beginning of the year	RSUs awarded	RSUs vested	RSUs subject to a service condition	RSUs awarded and unvested	RSUs held at the closing of the year	RSUs subject to a holding period
Mr. Peter Verhaeghe	24/12/2021 - 24/12/2025	24/12/2021	(1)	N/A	300	—	150	—	150	150	—
	23/12/2022 - 23/12/2026	23/12/2022	(1)	N/A	450	—	150	—	300	300	—
	03/07/2023 - 03/07/2027	07/03/2023	(1)	N/A	350	—	87	—	263	263	—
	28/06/2024 - 28/06/2025	28/06/2024	(1)	28/06/2028	—	1065	—	—	1,065	1,065	—
Total					1,100	1,065	387	—	1,778	1,778	—

Mr. Steve Krognes	03/04/2023 - 03/04/2027	03/04/2023	(1)	N/A	525	0		—	394	394	—
Mr. Steve Krognes	28/06/2024 - 28/06/2025	06/28/2024	(1)	28/06/2028	0	1,065	0	—	1,065	1,065	—
Total					525	1,065	131	—	1,459	1,459	—

Dr. Pamela Klein	24/12/2021 - 24/12/2025	24/12/2021	(1)	N/A	300	—	150	—	150	150	—
	23/12/2022 - 23/12/2026	23/12/2022	(1)	N/A	450	—	150	—	300	300	—
	03/07/2023 - 03/07/2027	07/03/2023	(1)	N/A	350	—	87	—	263	263	—
	28/06/2024 - 28/06/2025	28/06/2024	(1)	28/06/2028	—	1065	—	—	1,065	1,065	—
Total					1,100	1,065	387	—	1,778	1,778	—

Dr. Donald deBethizy	24/12/2021 - 24/12/2025	24/12/2021	(1)	N/A	300	—	150	—	150	150	—
	23/12/2022 - 23/12/2026	23/12/2022	(1)	N/A	450	—	150	—	300	300	—
	03/07/2023 - 03/07/2027	07/03/2023	(1)	N/A	350	—	87	—	263	263	—
	28/06/2024 - 28/06/2025	28/06/2024	(1)	28/06/2028	—	1065	—	—	1,065	1,065	—
Total					1,100	1,065	387	—	1,778	1,778	—


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					Information regarding the reported financial year
					Opening balance	During the Year		Closing balance
Anthony Rosenberg	24/12/2021 - 24/12/2025	24/12/2021	(1)	N/A	300	—	150	—	150	150	—
	23/12/2022 - 23/12/2026	23/12/2022	(1)	N/A	450	—	150	—	300	300	—
	03/07/2023 - 03/07/2027	07/03/2023	(1)	N/A	350	—	87	—	263	263
	28/06/2024 - 28/06/2025	28/06/2024	(1)	28/06/2028	—	1065	—	—	1,065	1,065	—
Total					1,100	1,065	387	—	1,778	1,778	—

James Daly	24/12/2021 - 24/12/2025	24/12/2021	(1)	N/A	300	—	150	—	150	150	—
	23/12/2022 - 23/12/2026	23/12/2022	(1)	N/A	450	—	150	—	300	300	—
	03/07/2023 - 03/07/2027	07/03/2023	(1)	N/A	350	—	87	—	263	263	—
	28/06/2024 - 28/06/2025	28/06/2024	(1)	28/06/2028	—	1065	—	—	1,065	1,065	—
Total					1,100	1,065	387	—	1,778	1,778	—

Camilla Sylvest	03/10/2022 - 03/10/2026	03/10/2022	(1)	N/A	675	—	225	—	450	450	—
	03/07/2023 - 03/07/2027	07/03/2023	(1)	N/A	263	—	66	—	197	197	—
	28/06/2024 - 28/06/2025	28/06/2024	(1)	28/06/2028	—	1065	—	—	1,065	1,065	—
Total					938	1,065	291	—	1,712	1,712	—

Dr. Ana Cespedes	23/12/2022 - 23/12/2026	23/12/2022	(1)	N/A	675	—	225	—	450	450	—
	03/07/2023 - 03/07/2027	07/03/2023	(1)	N/A	175	—	44	—	131	131	—
	28/06/2024 - 28/06/2025	28/06/2024	(1)	28/06/2028	—	1065	—	—	1,065	1,065	—
Total					850	1,065	269	—	1,646	1,646	—

Dr. Brian Kotzin	28/06/2024 - 28/06/2028	28/06/2024	(1)	28/06/2028	—	1,598	—	—	1,598	1,598	—
Total					—	1,598	—	—	1,598	1,598	—

1)RSUs granted before 2024 vest over a period of four years with 1/4th of the total grant vesting at each anniversary of the date of grant. RSUs granted to Non-Executive Directors in 2024 will all vest on

the 1st anniversary of the grant date in 2025 and are subject to a holding period of 3 years.


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C. BOARD PRACTICES

Director Independence

As a foreign private issuer, under the Nasdaq Listing Rules, we are not required to have a majority independent directors

on our Board of Directors, except that Audit and Compliance Committee is required to consist fully of independent

directors. However, our Board of Directors has determined that, taking into account any applicable committee

independence standards, all of our Non-Executive Directors, including the members of Audit and Compliance

Committee, are “independent directors” under Rule 10A-3 of the Exchange Act and the applicable rules of Nasdaq and

of the DCGC. In making such determination, our Board of Directors considered the relationships that each Non-

Executive Director has with us and all other facts and circumstances our Board of Directors deemed relevant in

determining the director’s independence, including the number of ordinary shares beneficially owned by the director and

his or her affiliated entities (if any).

The DCGC requires that the composition of Non-Executive Directors is such that the members are able to operate

independently and critically vis-à-vis one another, the Executive Directors, and any particular interests involved. As of

the date of this Annual Report, all Non-Executive Directors meet the independence criteria contained in the DCGC.

Therefore, in the opinion of the Non-Executive Directors, the composition of our Non-Executive Directors complies

with the independence requirements of best practice provisions 2.1.7 to 2.1.9 of the DCGC. Our Board of Directors has

consequently also determined that all members of our committees are independent under the applicable rules of the

DCGC.

As of the date of this Annual Report (or in any period before), none of the members of our Board of Directors and Senior

Management Team has or has had a family relationship with any other member of our Board of Directors or Senior

Management Team.

Directors may be suspended or removed by the General Meeting at any time, with or without cause, by means of a

resolution passed by a simple majority of the votes cast. Pursuant to the Dutch Civil Code, Executive Directors may also

be suspended by the board of directors. A suspension of an Executive Director by the board of directors may be

discontinued by the shareholders at any time at a General Meeting.

Diversity

In accordance with applicable Dutch legislation, we are required to report annually to the Social Economic Council

(Sociaal-Economische Raad) on (i) the gender ratio, i.e., the male and female Executive Directors and Non-Executive

Directors, as well as employees in managerial positions at the end of the financial year, (ii) the Company’s self-imposed

appropriate and ambitious targets in the form of a target figure to make the ratio between the number of male and female

Executive Directors and Non-Executive Directors, as well as in categories of employees in managerial positions to be

determined by the Company, more balanced, and (iii) the plan of action to achieve these targets. If we have not complied

with one or more of the foregoing, we are required to report on the reasons for this non-compliance.

As of December 31, 2024, our Board of Directors consisted of 10 directors, including 1 Executive Director and 9 Non-

Executive Directors. Of the directors who chose to disclose their gender, the Board of Directors contained 6 male

directors and 3 female directors (Non-Executive Directors), translating into a 60.00% male / 30.00% female balance for

our full Board of Directors (compared to 5 males and 3 females (Non-Executive Directors) (55.56%/33.33%) as of

December 31, 2023) and a 66.67% male / 33.33% female balance for our Non-Executive Directors (compared to 62.50%

male/37.50% female as of December 31, 2023).

As of December 31, 2024, our Company leadership team consisted of 57 persons, comprised of a mix of 24 males and 28

females, (42% / 49% respectively) while 5 positions remained vacant. Compared to 31 persons as of December 31, 2023,

comprised of a mix of 19 males and 12 females, (61% / 39% respectively). Our leadership consists of all full time

employees reporting directly to our CEO, as well as all (other) leaders of our largest functions and projects. Each of

these positions is characterized by a high impact across the organization, leading a global and cross functional team and

having a global reach. We estimate that as of December 31, 2024, 58% of our workforce were female and 42% were

male (compared to 58% female and 42% male as of December 31, 2023).

Role of the Board in Risk Oversight

Our Board of Directors is responsible for the oversight of our risk management activities and has specifically designated

the audit and compliance committee (the Audit and Compliance Committee) to assist our Board of Directors in this task

and prepare recommendations in this respect to the Board of Directors. While our Board of Directors oversees our risk

management, our Senior Management Team is responsible for day-to-day risk management processes. Our Board of

Directors expects our Senior Management Team to consider risk and risk management in each business decision, to

proactively develop and monitor risk management strategies and processes for day-to-day activities and to effectively


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implement risk management strategies adopted by the Board of Directors. We believe this division of responsibilities is

the most effective approach for addressing the risks we face.

Composition, Appointment and Dismissal

The Articles of Association provide that our Board of Directors will consist of our Executive Director(s) and Non-

Executive Directors. The number of Executive Directors must at all times be less than the number of Non-Executive

Directors. The number of directors, as well as the number of Executive Directors and Non-Executive Directors, is

determined by our Board of Directors, provided that the Board of Directors must consist of at least three members.

Our directors are appointed by the General Meeting for a period of four years as either Executive Directors or as Non-

Executive Directors. This four-year term aligns with best practice 2.2.1 of the DCGC, which stipulates that executive and

Non-Executive Directors may be appointed for a maximum period of four years. We believe that appointing directors for

a four-year term, rather than for example annual (re-)appointments, promotes stability and continuity within the Board of

Directors. It also allows deserving candidates to be appointed for more than one year, enhancing our position in

recruitment processes, as longer appointment periods are generally more attractive to candidates. Additionally, it

contributes to the Board of Directors' and, by extension, the Company's ability to focus on long-term goals, in line with

the DCGC's principle that a company's strategy should aim for sustainable long-term value creation.

In accordance with best practice provision 2.2.1 of the DCGC, Executive Directors may be reappointed for periods not

more than four years at a time. In accordance with best practice provision 2.2.2 of the DCGC, Non-Executive Directors

may be reappointed once for a period of four years, after which the Non-Executive Director may be reappointed again

for a period of two years, which reappointment may be extended by at most two years. In the event of a reappointment

after an eight-year period, reasons will be given in the report of the Board of Directors. The Board of Directors is

required to make one or more proposals for each seat on our Board of Directors to be filled. A resolution to nominate a

director by our Board of Directors (with support from the remuneration and nomination committee (the Remuneration

and Nomination Committee) may be adopted by a simple majority of the votes cast.

Our Board of Directors conducts evaluations of all its directors and director candidates to create a well-rounded board,

designed to promote long-term shareholder value creation through strong leadership and oversight. The Board of

Directors recognizes that directors who serve on the board for longer terms can be valuable sources of continuity,

understanding of the business and historical insight.

Our Board of Directors designates one Executive Director as CEO and may grant other titles to Executive Directors (if

appointed). Our Board of Directors also designates a Non-Executive Director as chairperson of the Board of Directors

and a Non-Executive Director as vice chairperson of the Board of Directors. The legal relationship between an executive

member of the Board of Directors and argenx SE will not be considered as an employment agreement. Employment

agreements between an Executive Director and a Group company (other than argenx SE) are permitted. In the absence of

an employment agreement, members of a board of directors generally do not enjoy the same protection as employees

under Dutch labor law.

For a discussion of date of expiration of the current term of office and the period during which the person has served in

that office, “Item 6.1. — Directors, Senior Management and Employees - Directors and Senior Management”.

Except for the arrangements described in “Item 7.B. — Related Party Transactions - Agreements with Our Senior

Management”, there are no arrangements or understanding between us and any of the Executive Directors providing for

benefits upon termination of their employment, other than as required by applicable law. In addition, the contracts

between us and our Non-Executive Directors do not provide for any benefits upon termination. In addition, the Company

is not party to any agreement with a director or employee providing for compensation if his or her employment is

terminated because of a public takeover offer in respect of the Company.

Committees

In accordance with the DCGC, our Non-Executive Directors can set up specialized committees to analyze specific issues

and advise the Non-Executive Directors on those issues and prepare resolutions with respect thereto.

The committees are advisory bodies only, and the decision-making remains within the collegial responsibility of the

Board of Directors. The Non-Executive Directors determine the terms of reference of each committee with respect to the

organization, procedures, policies and activities of the committee.

Our Non-Executive Directors have established and appointed (i) an Audit and Compliance Committee; and (ii) the

Remuneration and Nomination Committee.


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The composition and function of these committees complies with all applicable requirements of Euronext Brussels, the

DCGC, the Exchange Act, the exchange on which the ordinary shares and the ADSs are listed and U.S. SEC rules and

regulations.

Only Non-Executive Directors qualify for membership of these committees. The audit and compliance committee and

the Remuneration and Nomination Committee may not be chaired by the chairperson of the Board of Directors or by a

former Executive Director of the Company.

In addition to the aforementioned legally required subcommittees, our Board of Directors may also opt to incorporate

informal committees consisting of Non-Executive Directors and other internal and external persons in argenx, in order to

facilitate discussions and act as a sounding board on specific projects, as well as on a more permanent basis. Our Board

of Directors has incorporated a research and development committee and a commercialization committee.

Audit and Compliance Committee

Our Audit and Compliance Committee consists of four members: Mr. Steve Krognes (chairperson), Mr. Peter

Verhaeghe, Anthony Rosenberg and James Daly.

Our Board of Directors previously established that Mr. Peter Verhaeghe, Anthony Rosenberg, James Daly and Mr. Steve

Krognes satisfy the independence requirements set forth in Rule 10A-3 of the Exchange Act and that Mr. Steve Krognes

qualifies as “audit committee financial experts” as defined by SEC rules and Article 39 paragraph 1 of Directive

2014/56/EU of the European Parliament and of the Council of April 16, 2014 amending Directive 2006/43/EC on

statutory audits of annual accounts and consolidated accounts and has the requisite financial sophistication under the

applicable Nasdaq rules and regulations. Further, our Board of Directors established that the composition of the Audit

and Compliance Committee meets the requirements under the Dutch Decree on Establishing Audit Committees.

Our Audit and Compliance Committee assists our Board of Directors in overseeing the accuracy and integrity of our

accounting, financial and non-financial (including sustainability) reporting processes and audits and reviews of our

consolidated financial statements as well as non-financial statements, the implementation and effectiveness of an internal

control system and our compliance with legal and regulatory requirements, the independent auditors’ qualifications and

independence and the performance of the independent auditors. Our Audit and Compliance Committee is also

responsible for monitoring the status of, and compliance with, our global ethics and compliance program and meets with

the head of our ethics and compliance function at least quarterly to discuss the status and overall effectiveness of the

program as well as any issues or incidents that occurred and remedial actions needed (if applicable). The committee

furthermore oversees climate-related risks and supervises the status of the Company’s cybersecurity program and

regularly (at least quarterly) discusses the status thereof with our Senior Management Team.

Our Audit and Compliance Committee is governed by a charter that complies the Nasdaq Listing Rules and the DCGC

and is publicly available on our website. It is responsible for, among other things, establishing methods and procedures

for supervising, and where necessary requiring improvements of, our financial reporting, risk management, ethics and

compliance and organization for the purpose of making appropriate recommendations to our Board of Directors in that

regard.

Our Audit and Compliance Committee meets as often as is required for its proper functioning, but at least four times a

year and at least once a year meets separately with our independent auditor. Our Audit and Compliance Committee

reports regularly to our Board of Directors on the exercise of its functions. It informs our Board of Directors about all

areas in which action or improvement is necessary in its opinion and produces recommendations concerning the

necessary steps or resolutions that need to be taken. The audit review and the reporting on that review cover us and our

subsidiaries as a whole. The members of the Audit and Compliance Committee are entitled to receive all information

which they need for the performance of their function, from our Board of Directors and employees. Every member of the

Audit and Compliance Committee shall exercise this right in consultation with the chairperson of the Audit and

Compliance Committee. Please refer to “Item 6.C — Board Practices — Report Audit and Compliance Committee” for

an overview of the number of meetings and attendance rates.

Report Audit and Compliance Committee

The Audit and Compliance Committee reports regularly to our Board of Directors on the exercise of its functions. It

informs our Board of Directors about all areas in which action or improvement is necessary in its opinion and produces

recommendations concerning the necessary steps that need to be taken. The audit review and the reporting on that review

cover the Company and its subsidiaries as a whole.

In 2024, the main points of discussion at the meetings were the 2023 consolidated financial statements and press release

as well as interim consolidated financial statements and press releases, internal audit and external auditors’ reports, the

review of quarterly forecasts, updates on tax priorities, cash management, CSRD implementation (including finalization


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of the double materiality assessment), the Company’s ethics and compliance program, the Company’s cyber security

program and the Company’s privacy program.

In 2024, 6 formal Audit and Compliance Committee meetings were held. The meeting attendance rate for our Non-

Executive Directors is set out in the table below.


Name	Number of meetings attended in 2024 since appointment	Attendance %
Mr. Steve Krognes (chairperson)	6	100%
Mr. Peter Verhaeghe	6	100%
Anthony Rosenberg	6	100%
James Daly	6	100%

Remuneration and Nomination Committee

We have established a Remuneration and Nomination Committee, which serves as both the remuneration committee and

selection and appointment committee as prescribed by the DCGC. Our Remuneration and Nomination Committee

currently consists of three members: Dr. Donald deBethizy (chairperson), Peter Verhaeghe and Dr. Ana Cespedes. As

announced on February 27, 2025, Donald deBethizy will retire from the Board of Directors after the annual General

Meeting to be held on May 27, 2025 (the 2025 General Meeting). Consequently, Dr. Ana Cespedes will succeed Dr.

Donald deBethizy as the chairperson of the Remuneration and Nomination Committee and Mr. Steve Krognes will

become a member of the Remuneration and Nomination Committee.

Our Remuneration and Nomination Committee is responsible for, among other things:

•regularly reviewing the remuneration policy and practices in light of all relevant circumstances and benchmarks, and

recommending to the Non-Executive Directors the remuneration of the individual Executive Directors;

•advising our Board of Directors in respect of the remuneration for the Non-Executive Directors;

•preparing the remuneration report to be included in our annual report; and

•drawing up selection criteria and appointment procedures for directors and making proposals for appointment and re-

appointment of the directors.

The Remuneration and Nomination Committee consists of at least three members. The Remuneration and Nomination

Committee meets as often as is required for its proper functioning, but at least once per year to evaluate its functioning.

Please refer to “Item 6.C — Board Practices — Report Remuneration and Nomination Committee” for an overview of

the number of meetings and attendance rates.

Report Remuneration and Nomination Committee

The Remuneration and Nomination Committee assists the Board of Directors by, amongst other matters, regularly

reviewing our remuneration policy, preparing remuneration proposals and periodically assessing the size and

composition of the Board of Directors, as well as preparing the policy of the Senior Management Team on the selection

criteria and appointment procedures for the Senior Management Team. During their deliberations in 2024, the main

topics of discussion were long-term succession and development planning for key company leadership. The key themes

in 2024 were around our evolving remuneration practices and needs in light of stakeholder feedback and engagement,

leading up to a proposed revised remuneration policy in 2024 and preparations for a further revised policy to be

proposed in 2025.

In 2024, 6 formal Remuneration and Nomination Committee meetings were held. The meeting attendance rate for our

Directors is set out in the table below.


Name	Number of meetings attended in 2024 since appointment	Attendance %
Dr. Donald deBethizy (chairperson)	6	100%
Mr. Peter Verhaeghe	5	83.33%
Dr. Ana Cespedes	6	100%


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Informal subcommittees

Research and Development Committee

The research and development committee consists of members of our Board of Directors and other persons, which

composition may vary from time to time. Currently, the research and development committee consists of three members

who are also members of our Board of Directors: Dr. Brian Kotzin (chairperson), Dr. Donald deBethizy and Dr. Pamela

Klein. Non-board member advisors of the research and development committee include David Lacey, Prof. Hans de

Haard and Wim Parys. Ad-hoc participants to the committee meetings include a variety of employees and/or external

advisors, depending on the needs of the committee and the topics under discussion. As announced on February 27, 2025,

Dr. Donald deBethizy will retire from the Board of Directors after the 2025 General Meeting. The Board of Directors

will examine the options for a replacement.

The research and development committee is responsible for, among other things:

•monitoring and overseeing our research and development goals, strategies and measures;

•serving as a sounding board to our research and development management, general management and Board of

Directors; and

•performing strategic reviews of our key research and development programs. The research and development

committee also promotes transparency in R&D practices, ensuring that findings, both positive and negative, are

reported accurately and openly, and reviews, comments on and makes recommendations in respect of our non-

financial reporting on R&D related topics to the Audit and Compliance Committee and/or the Board of Directors.

All members of the research and development committee shall have adequate industrial, academic and/or practical

experience with the research and development of biopharmaceuticals.

Our research and development committee meets as often as is required for its proper functioning, but typically meets at

least once prior to each meeting of our Board of Directors and reports regularly to our Board of Directors on the outcome

of its deliberations, including any recommendations to the Board of Directors or the Senior Management Team. The

chairperson of our research and development committee reports to our Board of Directors on the research and

development committee’s discussions and strategic advice after each meeting on all matters within its duties and

responsibilities. Please refer to “Item 6.C — Board Practices — Report Research and Development Committee” for an

overview of the number of meetings and attendance rates.

Report Research and Development Committee

The research and development committee functions as a sounding board to our research and development management,

general management and the Board of Directors, and monitors our research and development goals, strategies and

measures. In 2024, the committee held 4 formal meetings, in which it focused mainly on the vision and strategy on

science, the Company’s research and development pipeline including its preclinical and clinical stage product-

candidates, potential future indications for its commercial stage products and developments in relation to our IIP.

The meeting attendance rate for our directors is set out in the table below.


Name	Number of meetings attended in 2024 since appointment	Attendance %
Dr. Brian Kotzin (chairperson) 1)	4	100%
Dr. Donald deBethizy	4	100%
Dr. Pamela Klein	4	100%
David Lacey (chairperson) 2)	4	100%

1)Dr. Brian Kotzin was appointed chairperson of the research and development committee as of May 7, 2024.

2)David Lacey resigned as chairperson effective May 7, 2024 and was replaced by Dr. Brian Kotzin effective May 7, 2024. He attended the other

meetings in 2024 as an advisor to the Board of Directors.

Commercialization Committee

Our commercialization committee consists of members of our Board of Directors and other persons, which composition

may vary from time to time. As of the date of this Annual Report, the commercialization committee consists of three


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permanent members: James Daly (chairperson), Anthony Rosenberg and Camilla Sylvest. Keith Woods serves as a non-

board member advisor of the committee.

The commercialization committee is responsible for, among other things:

•reviewing and guiding the global sales and marketing strategy to ensure optimal product uptake and sustained growth

and promoting innovation within commercialization efforts;

•overseeing the global product launch strategy and supervising all stages of product lifecycle; and

•reviewing our partnerships and collaborations.

Our commercialization committee meets as often as is required for its proper functioning and in practice meets at least

once per quarter. The commercialization committee reports regularly to our Board of Directors on the outcome of its

strategic reviews and any recommendations to the Board of Directors or Senior Management Team.

Please refer to “Item 6.C — Board practices — Report Commercialization Committee” for an overview of the number of

meetings and attendance rates.

Report Commercialization Committee

The commercialization committee functions as a sounding board on branded and unbranded strategic marketing plans for

the Board of Directors. In 2024, the committee held 3 formal meetings, in which it focused mainly on the execution of

our launch of VYVGART in CIDP, the execution of our launch of VYVGART in ITP in Japan and gMG in several other

jurisdictions as well as the preparation for potential future launches, subject to obtaining further approvals.

The meeting attendance rate for our directors is set out in the table below.


Name	Number of meetings attended in 2024 since appointment	Attendance %
James Daly (chairperson)	3	100%
Anthony Rosenberg	3	100%
Camilla Sylvest	3	100%

Corporate Governance Practices

Our Board By-Laws describe, inter alia, the procedure for holding meetings of the Board of Directors, for the decision-

making by the Board of Directors and the Board of Directors’ operating procedures.

In accordance with our Articles of Association, our Board of Directors meets at least once every three months to discuss

the state of affairs within the Company and the expected developments.

Under our Board By-Laws, the members of our Board of Directors must endeavor, insofar as is possible, to ensure that

resolutions are adopted unanimously. Where unanimity cannot be achieved and Dutch law, the Articles of Association or

the Board By-Laws do not prescribe a larger majority, all resolutions of our Board of Directors must be adopted by a

simple majority of the votes cast in a meeting at which at least a majority of the members of our Board of Directors then

in office are present or represented. The Articles of Association provide that in case of a tie of votes, the chairperson

does not have a casting vote and as such the proposal will be rejected in case of a tie.

Under the Board By-Laws, some specific matters require approval of the majority of the Non-Executive Directors. These

matters are set out in Schedule 1 of our Board By-Laws. Our Board By-Laws are available on our website. The Non-

Executive Directors may also determine that certain other matters shall require approval of a certain majority of the Non-

Executive Directors. Such matters shall be clearly specified and notified to the Executive Director(s) in writing.

Resolutions of the Board of Directors may also be adopted outside of a meeting in writing, provided that all directors in

office (in respect of whom no conflict of interest exists as referred to in the Articles of Association) have consented in

writing to this manner of decision-making. A director may issue a proxy for a specific Board of Directors meeting to

another director in writing.

A director having a direct or indirect personal interest that conflicts with the interest of the Company and its affiliated

enterprise has a conflict of interest. Each director shall inform all other directors of a conflict of interest without delay. A


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director shall not participate in the deliberations and decision-making process in relation to an item if he has a conflict of

interest with respect thereto. In such case, the other directors shall resolve the item. In case because of this no resolution

can be adopted by the Executive Directors, the Non-Executive Directors will resolve on the matter. In case because of

this no resolution can be adopted by the Non-Executive Directors, the Board of Directors will resolve on the matter as if

there were no conflict of interest.

The Executive Director(s) are required to be asked their vision on their own remuneration in accordance with best

practice provision 3.2.2 of the DCGC but may not participate in the adoption of resolutions (including any deliberations

in respect of such resolutions) relating to their remuneration.

Board Evaluation

The Board of Directors evaluates its functioning and the functioning of its committees and of each individual director

annually. The evaluation process is performed with the help of an external professional board evaluation consultant. In

2024, the evaluation was performed by Nasdaq Governance Solutions. The evaluation includes preparing specific

questionnaires focusing on the skills and competences most relevant to us, and the most material board topics and

challenges we face. The written questionnaire is then followed up by one-to-one interviews with the representative of

Nasdaq Governance Solutions with each member of the Board of Directors, followed by a debrief and discussion held

with the external evaluator and the entire Board of Directors both in writing (in form of a report) and in the form of a live

discussion of the evaluation report aimed at distilling specific learnings and conclusions.

Based on the self-evaluation performed, the Non-Executive Directors concluded that the Board of Directors and its

committees had properly discharged their responsibilities during 2024. The Board of Directors identified certain

strengths and weaknesses and adopted a plan for further board development and succession in 2025. All directors

consider the Board of Directors to be a high performing, engaged, open and transparent board. The importance to

preserve this was highlighted by Nasdaq Governance Solutions. All Non-Executive Directors consider fostering further

development and education of great importance, which can be furthered in 2025 through advisory board sessions, deep-

dives and other educational courses.

D. EMPLOYEES

As of December 31, 2024, we had 1,599 employees and 774 consultants, which we refer to as “contingent workers”. At

each date shown below, we had the following number of employees, broken out by department and geography.


	As of December 31,
	2024	2023	2022
Function:
Research and development	644	653	367
Selling, general and administrative	955	495	476
Total	1,599	1,148	843
Geography:
Belgium	466	355	363
U.S.	694	454	340
Japan	139	116	75
The Netherlands	34	22	—
Switzerland	49	28	15
France	38	40	11
Germany	41	25	11
Canada	19	16	5
UK	44	37	—
Italy	33	27	—
Spain	32	20	—
Rest of the World/Remote	10	8	23
Total	1,599	1,148	843


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Collective bargaining agreements (CBAs) can be entered into in Belgium at the national, industry, or company levels.

These CBAs are binding on both employers and employees. We have no trade union representation or CBAs at the

company level, but we are subject to the national and chemical industry CBAs. The CBAs currently applicable to us

relate to employment conditions such as wages, working time, job security, innovation and supplementary pensions. We

have not had, and do not anticipate having, disputes on any of these subjects. CBAs may, however, change the

employment conditions of our employees in the future and hence adversely affect our employment relationships.

E. SHARE OWNERSHIP

For information regarding the share ownership of our directors and members of our executive committee, see “Item 6.B.

— Compensation” and “Item 7.A. — Major Shareholders”.

F. DISCLOSURE OF A REGISTRANT’S ACTION TO RECOVER ERRONEOUSLY AWARDED

COMPENSATION

Not applicable.

ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS

A. MAJOR SHAREHOLDERS

The following table sets forth information with respect to the beneficial ownership of our ordinary shares as at February

19, 2025 for:

•each person who is known by us to own beneficially more than 3% of our total outstanding ordinary shares;

•each member of our Board of Directors and our Senior Management Team; and

•all members of our Board of Directors and our Senior Management Team as a group.

Beneficial ownership is determined in accordance with the rules of the SEC, which may materially differ from other

rules applicable to us. The SEC rules generally attribute beneficial ownership of securities to persons who possess sole

or shared voting power or investment power with respect to those securities and include ordinary shares that can be

acquired within 60 days of February 19, 2025. The percentage ownership information shown in the table is based upon

60,990,857 ordinary shares outstanding as at February 19, 2025.

Except as otherwise indicated, all of the shares reflected in the table are ordinary shares and all persons listed below have

sole voting and investment power with respect to the shares beneficially owned by them, subject to applicable

community property laws. The information is not necessarily indicative of beneficial ownership for any other purpose.

In computing the number of ordinary shares beneficially owned by a person and the percentage ownership of that person,

we deemed outstanding ordinary shares subject to options held by that person that are immediately exercisable or

exercisable within 60 days of February 19, 2025. We did not deem these shares outstanding, however, for the purpose of

computing the percentage ownership of any other person. The information in the table below is based on information

known to us or ascertained by us from public filings made by the shareholders.


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	Shares beneficially owned
Name of beneficial owner	Number	Percentage
3% or Greater Shareholders:
FMR LLC (1)	6,019,640.29	10.00%

T. Rowe Price Group, Inc. (2)	5,822,086.00	9.70%

Blackrock, Inc. (3)	3,658,398.00	6.11%
	4,200,942 (voting)	6.96 (voting)%
Artisan Partners Limited Partnership (4)	3,015,243.00	5.00%

Wellington Management Group LLP (5)	—	—%
	2,150,704 (voting)	3.62 (voting) %
Capital Research and Management Company (6)	—	—%
	1,837,683 (voting)	3.07 (voting) %
Janus Henderson Group plc (7)	1,784,723.00	3.02%

Directors and Senior Management
Tim Van Hauwermeiren (8)		* %
Dr. Donald deBethizy (9)		* %
Mr. Steve Krognes (10)		* %
Mr. Peter Verhaeghe (11)		* %
Dr. Pamela Klein (12)		* %
Anthony Rosenberg (13)		* %
James Daly (14)		* %
Camilla Sylvest (15)		* %
Ana Cespedes (16)		* %
Brian Kotzin		—%
Karen Massey (17)		* %
Karl Gubitz (18)		* %
Luc Truyen (19)		* %
Peter Ulrichts (20)		* %
Arjen Lemmen (21)		* %
Malini Moorthy (22)		* %
Andria Wilk (23)		* %
All executive officers and directors as a group (17 persons)		1.17%

•Indicates beneficial ownership of less than 1% of the total outstanding ordinary shares.

1)Based on the most recently available Schedule 13G filed with the SEC on February 12, 2025. According to its Schedule 13G, FMR LLC reported

having sole voting power over 5,708,605.90 ordinary shares and sole dispositive power over 6,019,640.29 ordinary shares. The Schedule 13G

contained information as of December 31, 2024 and may not reflect current holdings of the Company’s stock. Abigail P. Johnson is a director,

the chairman and the chief executive officer of FMR LLC. Members of the Johnson family, including Abigail P. Johnson, are the predominant

owners, directly or through trusts, of Series B voting common shares of FMR LLC, representing 49% of the voting power of FMR LLC. The

Johnson family group and all other Series B shareholders have entered into a shareholders' voting agreement under which all Series B voting

common shares will be voted in accordance with the majority vote of Series B voting common shares. Accordingly, through their ownership of

voting common shares and the execution of the shareholders' voting agreement, members of the Johnson family may be deemed, under the

Investment Company Act of 1940, to form a controlling group with respect to FMR LLC. FMR LLC’s principal business office is located 245

Summer Street, Boston, MA 02210.

2)Based on the most recently available Schedule 13G filed with the SEC on November 14, 2024. According to its Schedule 13G, T. Rowe Price

Associates, Inc. reported having sole voting power over 5,683,883 ADSs and sole dispositive power over 5,811,073 ADSs. The Schedule 13G

contained information as of September 30, 2024 and may not reflect current holdings of the Company’s stock. The address for T. Rowe Price

Associates, Inc. is 100 E. Pratt Street, Baltimore, MD 21202.

3)Based solely on the most recent transparency notification filed with Dutch the Authority for the Financial Markets (Stichting Autoriteit

Financiële Markten) (AFM) as of February 19, 2025. Consists of (a) 2,674,291 ordinary shares, 355 contracts for difference, and 1,010,752 stock

certificates (certificaat van aandeel) and (b) voting rights on (i) 3,084,810 ordinary shares, (ii) 512 contracts for difference, and 1,115,620 stock

certificates (certificaat van aandeel). Other information regarding this shareholder’s beneficial ownership of our shares is not known to us or, to

our knowledge, ascertainable from public filings.

4)Based solely on the most recent transparency notification filed with the AFM as of February 19, 2025. Consists of 215,293 ordinary shares and

2,799,950 stock certificates (certificaat van aandeel). Other information regarding this shareholder’s beneficial ownership of our shares is not

known to us or, to our knowledge, ascertainable from public filings.


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5)Based solely on the most recent transparency notification filed with the AFM as of February 19, 2025. Consists of voting rights on 330,691

ADSs, 1,819,494 ordinary shares, and 519 total equity return swaps. Other information regarding this shareholder’s beneficial ownership of our

shares is not known to us or, to our knowledge, ascertainable from public filings.

6)Based solely on the most recent transparency notification filed with the AFM as of February 19, 2025. Consists of voting rights on 206,694

ordinary shares and 1,630,989 ADSs. Other information regarding this shareholder’s beneficial ownership of our shares is not known to us or, to

our knowledge, ascertainable from public filings.

7)Based solely on the most recent transparency notification filed with the AFM as of February 19, 2025. Consists of 10,882 ordinary shares and

1,773,841 ADSs. Other information regarding this shareholder’s beneficial ownership of our shares is not known to us or, to our knowledge,

ascertainable from public filings.

8)Consists of (1) 67,088 ordinary shares (of which 14,343.69 ordinary shares are directly and indirectly held by Mr. Van Hauwermeiren and

52,744.31 ordinary shares are indirectly held by three of Mr. Van Hauwermeiren’s direct family members (being (i) his partner, Ms Vissers; (ii)

his daughter, Ms. F. Van Hauwermeiren; and (iii) his daughter, Ms. T. Van Hauwermeiren, who each hold the interest in these ordinary shares

through an entity, Stichting Administratiekantoor Cinclus, which entity in turn holds the interest in these ordinary shares through the Belgian civil

company (société civile/burgerlijke maatschap) “TVHNV”), and (2) 271,944 shares issuable upon the exercise of stock options that are

immediately exercisable or exercisable within 60 days of February 19, 2025.

9)Consists of 837 ordinary shares and 42,700 shares issuable upon the exercise of stock options that are immediately exercisable or exercisable