Annual Report 2025

Annual Report 2025

Social

Own Workforce (S1)

Material Impacts, Risks and Opportunities (SBM-3)

Innovation is at the core of our business, and investing in our people is essential to sustaining it. Our business model depends on cutting-edge research and the continuous development of scientific and technical expertise to advance innovation in immunology. Our success relies on a healthy and highly skilled workforce including employees, contingent workers, independent consultants, and partners who collectively drive our progress. We strive to maintain an inclusive, feedback‑driven culture and maintain clear expectations for safety, conduct, and well‑being to strengthen our ability to navigate workforce‑related risks that could affect continuity, compliance, or innovation capacity. This focus on people helps us to remain equipped with the talent, expertise, and culture necessary to advance immunology innovation and deliver on our long‑term strategic objectives.

S1 Own Workforce – Material Impacts, Risks and Opportunities

 

 

 

 

IRO Type

 

Value Chain

 

Time Horizon

Equal treatment and opportunities for all

 

Training and skills development
Unequal opportunities for training, skill development, and internal advancement across regions or roles, particularly in fast-paced or resource-constrained teams, may limit employee growth and satisfaction.

 

Potential negative impact

 

  • Own operations

 

  • Medium-term

 

Diversity
A lack of diversity, inclusion, and equity across the global workforce, especially within global and specialized Research and Development teams, may undermine employee well-being.

 

Potential negative impact

 

  • Own operations

 

  • Short-term

Working conditions

 

Health and safety
Exposure to hazardous substances and biological agents in research and operational roles within the Company’s own operations may compromise the physical and psychological well-being of employees.

 

Potential negative impact

 

  • Own operations

 

  • Short-term

Processes for Engaging With Own Workforce and Workers’ Representatives About Impacts (S1-2, SBM-3)

All employees are co-owners who contribute to our broader purpose and success. We engage directly with employees and encourage open dialogue through regular forums such as quarterly Company-wide meetings, focus groups, and new-hire check-ins.

  • Employees can contribute to the agenda of quarterly Company-wide meetings (“Corporate Updates”) by submitting questions in advance and can also raise additional questions live during the meeting.
  • We have established a network of ’Culture Champions’—nominated employees—who host ongoing cultural dialogue sessions. Insights from these sessions inform employee programs and help guide leadership in advancing employee engagement opportunities.
  • Office and campus site teams host quarterly focus groups on topics including well-being, development, health and safety, and other employee initiatives.
  • New-hire check-ins are hosted by members of the HR team after the first three months.
  • CEO welcome sessions are held to introduce new hires to argenx.

We also engage employees through various ongoing communication channels. All employees are invited to share ideas and questions through ‘Engage’, our internal social networking platform. The Employee Communications team provides weekly Company-wide updates and a monthly ‘In Case You Missed It’ recap. Employees also receive an internal notification whenever a company press release is issued.

We assess the effectiveness of employee engagement, with oversight from the Global Head of Human Resources, by gathering feedback through focus group discussions, employee questions and comments submitted before Corporate Updates, and analysis of engagement with internal communication channels. To strengthen communication and collaboration, employees are trained on the Situation-Behavior-Impact (SBI) feedback model, which promotes clear, actionable, and constructive feedback. We do not currently have a separate process to gain insights into the perspectives of particularly vulnerable employee groups.

Processes to Remediate Negative Impacts and Channels for Own Workforce to Raise Concerns (S1-3)

We provide multiple channels for employees to raise questions, concerns, or file reports. For health and safety related matters, employees can contact their respective HR Business Partner or contact the Global Facilities and Employee Health and Safety (EHS) Lead directly if involved in an incident. For other matters, communication channels include the argenx Helpline, HR and Legal teams. These channels are introduced to all employees during onboarding.

Our Anti-Retaliation Policy, detailed in Section 7.4.1.3. “Protection of Whistleblowers”, strictly prohibits retaliation against anyone who raises a concern in good faith. For more information on our anti-retaliation procedures and how we enable employees to speak up, see the Governance section of this Sustainability Statement.

Equal Treatment and Opportunities for All

Policies (S1-1, SBM-3, MDR-P)

We uphold the right to freedom of association and maintain a zero-tolerance stance on workplace discrimination. Our Code of Conduct and Business Ethics, as detailed in Section 7.4.1.2. “Corporate Culture”, outlines our policies for prohibiting and preventing discrimination based on categories, including but not limited to race, religion, color, political convictions, gender, sex, pregnancy, ethnicity or national origin, civil state, social status, sexual orientation, disability (or handicap), or age. Our Anti-Retaliation Policy prohibits discrimination against employees who raise complaints. Our approach to equal treatment and opportunity is further supported by the following policies:

S1 Own Workforce – Policies for Equal Treatment and Opportunities

Policy

 

Managing Training standard operating procedure

Purpose

 

Establish a uniform approach to training, including how training is managed and assigned. Promote equal treatment and professional conduct through uniform training.

Scope

 

All employees, consultants, interns, and contractors

Most senior level accountable

 

Head of Quality

Availability

 

Internal document-sharing platform

Process for monitoring

 

Quarterly Quality Management Review

Applicability across sustainability statement

 

Section 7.3.1 “Own Workforce (S1)

 

 

 

Policy

 

Diversity, Equity and Inclusion Policy

Purpose

 

Support a workforce that is composed of members that can provide broad and complementary perspectives of the various business goals and strategic objectives of our company. Comply with the requirement we are subject to pursuant to the Dutch Civil Code and the Dutch Decree on the Content of the Management Report to disclose our diversity policy with respect to our directors and employees in managerial positions to the Dutch Social and Economic Council (Sociaal Economische Raad).

Scope

 

All global operations

Most senior level accountable

 

Head of HR and General Counsel and Corporate Secretary

Availability

 

Externally available: Diversity Equity and Inclusion Policy

Process for monitoring

 

No formal monitoring

Applicability across sustainability statement

 

Section 7.3.1 “Own Workforce (S1)

We do not have a separate policy or program that manages impacts related to human rights. We engage with third parties who align with our values and endeavor to not conduct business with any individual or organization that participates in activities we prohibit. We comply with international labor standards and applicable employment laws in our regions of operation. This includes, but is not limited to, the prohibition of child exploitation and child labor, forced, bonded, or indentured labor and involuntary prison labor, harsh or inhumane treatment, the threat thereof, or any form of modern slavery or human trafficking. We review our initiatives to facilitate compliance with local laws, and individual employment decisions are based on merit, consistent with our philosophy and applicable laws.

We have not conducted a direct assessment of whether any of our operations are at heightened risk of forced, compulsory, or child labor. However, our owned operations are located in geographies and involve activities that are not typically associated with elevated risks of these issues.

Actions (S1-4, MDR-A)

At the recruitment stage, we follow a standardized process designed to promote inclusion and avoid bias. The same principle guides promotions, training, and career development, which are based on job-related criteria such as skills and experience. Our employee resource groups also help advance inclusion by fostering dialogue and supporting related educational programs.

We strive to create a workplace where all employees are empowered to excel and are supported in their development. To enable this, we provide access to role-specific learning resources aligned with Personal Development Plans (PDPs), which outline a strength-based development path, and formal leadership programs. Program effectiveness is evaluated through participant surveys.

Recognizing that continuous feedback promotes employee growth, we encourage all employees to give and request feedback year-round, rather than relying on an annual review process. To support this, we provide training on the SBI feedback model, which encourages open dialogue and supports a culture of continuous improvement. For more information on our policies and procedures related to employee feedback and reporting channels, visit the Governance section of this statement.

Targets (S1-5, MDR-T)

We have not adopted targets in relation to own workforce metrics and instead are focused on monitoring and responding to trends in our workforce metrics.

Metrics (MDR-M)

Employee Age Distribution (S1-9)
S1 Own Workforce – Employee Age Distribution

 

 

 

 

Number of Employees (Headcount)

Age Group

 

Unit

 

2025

 

2024

Under 30 years old

 

Number

 

102

 

95

30–50 years old

 

Number

 

1,203

 

982

Over 50 years old

 

Number

 

558

 

522

Total

 

Number

 

1,863

 

1,599

Gender Distribution of Top Management (S1-9)
S1 Own Workforce – Gender Distribution of Top Management

Gender

 

Unit

 

2025

 

2024

 

Unit

 

Percentage 2025

 

Percentage 2024

Female

 

Number

 

39

 

28

 

%

 

50

 

49.1

Male

 

Number

 

39

 

24

 

%

 

50

 

42.1

Not reported

 

Number

 

 

 

%

 

 

Other

 

Number

 

 

5

 

%

 

 

8.8

Total

 

Number

 

78

 

57

 

%

 

100

 

100

Training and Skills Development Metrics (S1-13)

We have applied transitional relief under ESRS S1-13 for the second year Sustainability Statement preparation

Remuneration (Pay Gap and Total Remuneration) (S1-16)

The remuneration ratio below is defined under ESRS and is presented differently under the Remuneration and Compensation Statement in Section 3.4 of this Annual Report. The figure for 2025 is 25. In 2024, this figure was 23.

Our commitment to pay equity is deeply rooted in our core values and cultural foundation. We ensure that our remuneration practices are fair, reflecting team and individual impact. They are also based on skills and market competitiveness relevant to the responsibilities held.

The gender pay gap as presented in the below table reflects the adjusted gender pay gap for comparable positions, responsibilities, skill sets and experiences following the ESRS methodology but clustered in the following five categories:

  • Individual contributor;
  • Managers;
  • Directors;
  • Vice-Presidents;
  • Executives (excluding the CEO).

The metric is calculated as the average male gross hourly pay level less the average female gross hourly pay level expressed as a percentage of the average male gross hourly pay level

(Average gross hourly pay for male employees – Average gross hourly pay for female employees) / (Average gross hourly pay for male employees) * 100.

Using this methodology the gender pay gaps range from -7% to +2.5% with a weighted average of 4.6% in favor of women, reflecting our commitment and continuous monitoring of the core principles as laid out above.

S1 Own Workforce – Gender Pay Gap

Level

 

Gender Pay Gap – 2025

 

Gender Pay Gap – 2024

Individual Contributors

 

(3.9%)

 

(5.1%)

Managers

 

(7.1%)

 

(6.0%)

Directors

 

(3.8%)

 

(5.6%)

Vice-Presidents

 

2.5%

 

1.0%

Executives excluding CEO

 

(5.4%)

 

(2.7%)

Weighted average gender pay gap

 

(4.6%)

 

(5.4%)

We believe that examining gender pay gaps on a purely total population basis without adequate detail and precision, as required by ESRS, does not offer a meaningful metric or insight into the fairness of our employee compensation. It disregards experience, seniority, and cost-of-living differences by country. We believe that the unadjusted gender pay gap ratio provides an inaccurate and overly simplistic representation of a complex measure.

If all relevant factors are disregarded, the value for 2025 would be 18%, as calculated under ESRS. This figure for 2024 was 18%.

Accounting Policies

Top management refers to the leadership team, including the Executive Management Team, major global and commercial leaders, major development project leaders, and key R&D leaders. “Other” within gender distribution of top management refers to vacant top-management positions.

Own Workforce Health and Safety

Policies (S1-1, MDR-P)

While we do not maintain a formal, standalone workplace accident prevention policy, our Code of Business Conduct and Ethics includes a commitment to maintaining a safe and healthy workplace. We comply with applicable health and safety regulations and have implemented processes to prevent work-related incidents.

Actions (S1-4, MDR-A)

We provide laboratory employees with training on safe chemical handling, waste management, and biosafety practices. As a preventative measure, we also conduct lab audits to raise awareness, verify that policies are understood and applied in daily work, and identify opportunities for improvement.

Targets (S1-5, MDR-T)

We have not adopted targets in relation to workforce health and safety and instead maintain an objective to minimize incidents across our operations.

Metrics (MDR-M)

Work-related fatalities and injuries (S1-14)
S1 Own Workforce – Work-related Fatalities and Injuries

Metric Description

 

Unit

 

2025

 

2024

Number of fatalities in own workforce as result of work-related injuries and work-related ill health

 

Number

 

 

Number of recordable work-related accidents for own workforce

 

Number

 

 

1

Percentage of own workforce who are covered by health and safety management system based on recognized standards or guidelines and which have been internally audited and/or audited or certified by an external party

 

%

 

 

Rate of recordable work-related accidents for own workforce

 

Number

 

 

0.000018

Accounting Policies

Work-related fatalities and injuries reported in headcount reflect employees and do not include contractors or others from third-party companies. Percentage of own workforce who are covered by health and safety management system based on recognized standards or guidelines and which have been internally audited and/or audited or certified by an external party only reflects coverage by recognized standards and guidelines, this metric does not relate to legal requirements.

Characteristics of Workforce

Metrics (MDR-M)

Characteristics of Own Employees (S1-6)

Headcount and turnover

S1 Own Workforce – Characteristics of Own Employees

Metric

 

Unit

 

2025

 

2024

Disclose the total number of employees by headcount

 

Number

 

1,863

 

1,599

Total number of employees who have left the Company during the reporting period

 

Number

 

104

 

96

Number of employees hired

 

Number

 

365

 

524

Disclose employee turnover rate during reporting period

 

Percentage

 

6.0%

 

6.7%

Geographic Distribution and Gender Distribution (S1-6)
S1 Own Workforce – Gender Distribution

Gender

 

Number of employees (Headcount) – 2025

 

Percentage

 

Number of employees (Headcount) – 2024

 

Percentage

Female

 

1,134

 

60.9%

 

957

 

59.8%

Male

 

729

 

39.1%

 

642

 

40.2%

S1 Own Workforce – Geographic Distribution

 

 

 

 

Number of Employees (Headcount)

Country

 

Unit

 

2025

 

2024

Belgium

 

Number

 

565

 

466

Japan

 

Number

 

146

 

139

United States

 

Number

 

789

 

694

Other

 

Number

 

363

 

300

Total

 

Number

 

1,863

 

1,599

Employees by Contract Type (S1-6)
S1 Own Workforce – Employees by Contract Type

 

 

 

 

2025

 

2024

Metric

 

Unit

 

Female

 

Male

 

Other

 

Not
reported

 

Total

 

Female

 

Male

 

Other

 

Not
reported

 

Total

Number of employees (Headcount)

 

Number

 

1,134

 

729

 

 

 

1,863

 

957

 

642

 

 

 

1,599

Number of permanent employees

 

Number

 

1,133

 

728

 

 

 

1,861

 

956

 

641

 

 

 

1,597

Number of temporary employees

 

Number

 

1

 

1

 

 

 

2

 

1

 

1

 

 

 

2

Number of non-guaranteed hours employees

 

Number

 

 

 

 

 

 

 

 

 

 

Accounting Policies

Headcount represents the total number of employees as of December 31st, 2025. Turnover is calculated using average headcount at year-end as the denominator. Data is complied from our internal HR system (Workday). For additional employee data, see “Note 19 Personnel Expenses”. The geographic breakdown includes countries with more than 50 employees, that represent at least 10% of our total workforce. Entities with fewer than 50 employees are consolidated and reported under "Other.” For 2025, “Other” includes Australia, Austria, Brazil, Canada, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom. Within contract type by gender, “Not reported” indicates employees who chose not to disclose this information.

Characteristics of Non-Employees in the Workforce (S1-7)

We have applied transitional relief under ESRS S1-7 for the second year Sustainability Statement preparation.

Discrimination Incidents Reported and Complaints Filed (S1-17)
S1 Own Workforce – Discrimination Incidents Reported and Complaints Filed

Metric

 

2025

 

2024

Total number of incidents of discrimination including harassment reported in the reporting period

 

131)

 

11

Number of complaints filed through channels for workforce

 

61)

 

Total amount of fines, penalties, and compensation for damages due to incidents of discrimination, including harassment and complaints filed

 

 

Total amount of fines, penalties and compensation for damages due to cases of severe human rights incidents

 

 

Number of severe human rights incidents including an indication of how many are cases of non-respect of the UN Guiding Principles on Business and Human Rights, ILO Declaration on Fundamental Principles and Rights at Work, or OECD Guidelines for Multinational Enterprises – 2025

 

 

1)

None of the matters were substantiated as discrimination, harassment, a severe human rights incident, or any other instance of unlawful conduct or activity.

The Company may become aware of workforce concerns from time to time, both internally and externally. We take these matters seriously. In line with our commitment to maintaining a safe workplace, respecting human rights, and providing equal treatment and equal employment opportunities, we take prompt and appropriate action when such concerns are raised.

Accounting Policies

We track workforce concerns, including equal employment opportunity matters and complaints or incidents related to discrimination and harassment. In 2025, 19 such matters were reported, including 6 complaints and 13 incidents of discrimination and/or harassment. None of the 19 matters were substantiated as discrimination, harassment, a severe human rights incident, or any other instance of unlawful conduct or activity. In 2024, 11 matters were reported, all relating to discrimination or harassment, and none were substantiated.

Patients (S4)

In accordance with the European Commission’s “Quick-Fix” amendment, we have applied the phase-in relief for ESRS S4 Patients. Given the central importance of patients to our business model, we have included the most salient and decision-useful information in this S4 section to ensure that reporting remains focused on the most relevant impacts and stakeholder information needs. This section provides a summary of the material impacts, risks, and opportunities identified, together with an overview of related policies, actions, targets, and entity-specific metrics, in line with the disclosure requirements set out in ESRS 2 BP-2 (17).

Material Impacts, Risks and Opportunities (SBM-3)

Patients (S4) – Material Impacts, Risks and Opportunities

 

 

 

 

IRO Type

 

Value Chain

 

Time Horizon

Information-related impacts for patients

 

Privacy
Inadvertent exposure of sensitive patient information may increase the risk of fines and penalties, lawsuits, remediation costs and reputational damage to the Company, and may undermine patient trust in healthcare innovation.

 

Risk

 

  • Upstream
  • Own operations
  • Downstream

 

  • Short-term

 

Access to quality information
Failure to ensure transparent, accurate, and compliant product information (including labelling, usage instructions, and risk disclosures) may compromise patient safety, damage trust with healthcare professionals and regulators, and lead to financial and regulatory penalties.

 

Risk

 

  • Own operations
  • Downstream

 

  • Short-term

 

Access to quality information
Misleading or incomplete product information (e.g., improper dosing or contraindication risks) can lead to patient harm, particularly in complex autoimmune treatments.

 

Potential negative impact

 

  • Downstream

 

  • Medium-term

Personal safety of patients

 

Health and safety
Failing to ensure the safety of clinical trial participants, whether due to investigational product issues or inadequate oversight of contract research partners, can lead to direct harm to patient health and well-being.

 

Potential negative impact

 

  • Downstream

 

  • Short-term

 

Health and safety
Variability in product quality across a globally distributed manufacturing network could compromise treatment efficacy and patient safety.

 

Potential negative impact

 

  • Upstream
  • Own operations
  • Downstream

 

  • Medium-term

 

Health and safety
Insufficient product traceability and transparency may enable counterfeit or compromised drugs to enter the supply chain, posing serious risks to patient safety.

 

Potential negative impact

 

  • Upstream
  • Downstream

 

  • Medium-term

 

Health and safety
Risk of clinical trial suspension, reputational damage and future regulatory hurdles as a result of adverse side-effects observed during clinical trials, including unforeseen reactions, if not appropriately addressed.

 

Risk

 

  • Own operations
  • Downstream

 

  • Medium-term

Social inclusion of patients

 

Access to products and services
Expanding geographical access to antibody therapies through easier-to-administer injection formats, regional partnerships, and tailored pricing strategies may help to reduce treatment disparities, particularly for patients with rare diseases in underserved regions, and allows more patients to be treated.

 

Actual positive impact

 

  • Downstream

 

  • Medium-term

 

Access to products and services
Increased and better access to medicines through improving commercial/distribution channels and affordability and pricing initiatives may lead to a growth in market capacity.

 

Opportunity

 

  • Own operations
  • Downstream

 

  • Medium-term

 

Responsible marketing practices
Off-label promotion may expose pharmaceutical companies to legal, financial, and reputational risks, inviting regulatory scrutiny and liability.

 

Risk

 

  • Own operations
  • Downstream

 

  • Medium-term

Entity-specific topic

 

Innovation and R&D
Ongoing investment in immunology research and therapeutic innovation supports the development of treatments for high-burden, underserved autoimmune diseases.

 

Actual positive impact

 

  • Own operations

 

  • Long-term

Policies (MDR-P)

Patients (S4) – Policies

ESRS Sub-Topic

 

Policy

 

Description

Privacy

 

Information Security Policy

 

Includes specific technical measures reviewed by the Information Security and Privacy team, in accordance with applicable laws and regulations (e.g., access control, password protection, encryption). It also features increased strictness in cases where our personnel are expected to process sensitive patient information (e.g., limited access, pseudonymization, limited disclosure).

Access to quality information and responsible marketing

 

Global Commercial Materials and Medical Education Materials Review Committee Policy

 

Provides guidelines for responsible marketing and the dissemination of scientific information, including a prohibition on off-label promotion; requires all promotional and medical education materials to undergo internal review and approval by the Materials Review Committee (MRC) or Medical Materials Review Committee (MMRC) prior to use.

 

Code of Conduct and Business Ethics

 

Refer to Section 7.4.1.2. “Corporate Culture” for more information.

Patient data privacy

 

Global Data Privacy Policy

 

Outlines data privacy principles and safeguards for data subjects, including patients, covering the responsible collection and use of sensitive personal data; overseen by the Data Protection Officer, who reports to the General Counsel and Corporate Secretary and is responsible for implementing the policy, with involvement from the Global Compliance Committee and the Audit and Compliance Committee, which oversee the privacy program.

Patient health and safety

 

Global Patient Safety Policy

 

Outlines patient safety commitments, including the prevention and mitigation of any harm arising from the use of argenx products, protection of individuals and public health based on safety comprehensive information, and transparency through the reporting of safety information and/or safety issues. The Chief Medical Officer is accountable for implementing this policy.

 

Quality Policy

 

Outlines our commitment to quality through alignment with regulatory requirements and established quality standards, with a focus on meeting customer expectations while ensuring safe and effective products.

 

EU Serialisation Policy

 

Outlines the processes and procedures within the product lifecycle related to compliance with the EU Falsified Medicines Directive (FMD) serialisation program.

 

US Serialisation Policy

 

Outlines the processes and procedures within the product lifecycle related to compliance with the US Drug Supply Chain Security Act (DSCSA).

Access to medicines

 

Pre-Approval Access Global Policy

 

Outlines the principles governing PAA for unapproved products, covering all global PAA requests and activities, including those conducted by contracted partners.

 

Post-Trial Access Policy

 

Details the evaluation and approval process for post-trial access (PTA) to investigational products, including all PTA requests from patients previously enrolled in an argenx clinical trial.

Actions

Access to quality information and responsible marketing

External communications about products and therapeutic areas undergo an internal review by the MRC or MMRC before use to confirm that all information is accurate, truthful, non-misleading, scientifically substantiated, consistent with product labeling (where applicable), and balanced between risks and benefits. Each review committee consists of cross-functional personnel, including Medical, Legal, and Regulatory experts. Compliance monitoring and internal audits help ensure ongoing adherence and avoid potential deviations. Patients may report concerns about marketing practices to state and federal regulatory authorities, after which we review the matter and take appropriate action.

Reviews are also conducted by a multidisciplinary labeling working group and a Global Labeling Committee who document findings and monitor progress.

We adhere to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code of Conduct, which defines ethical interactions with healthcare professionals, healthcare organizations, and patient organizations, supporting responsible promotion of medicinal products.

Patient Health and Safety

We have procedures in place to safeguard patient health and to align with global and local pharmacovigilance regulations and standards. This includes signal detection—identifying, evaluating, and acting on potential associations between medicinal products and adverse events, and determining recommendations.

To mitigate the risk of falsified or counterfeit medicines, we follow a standardized reporting process. In suspected cases, affected batches are isolated, quarantined, and investigated. If counterfeit products are confirmed, relevant supply-chain stakeholders and authorities are notified, and market actions are taken in consultation with authorities.

In line with the Global Patient Safety Policy, we communicate significant safety findings that affect the benefit-risk balance of our products to all applicable parties, including health authorities, patients, and healthcare providers.

To protect clinical trial participants, we train clinical investigators and site staff on study protocols and trial requirements and regularly monitor trial sites for compliance.

We monitor pharmacovigilance compliance through defined metrics and implement corrective and preventive actions (CAPA) when thresholds are not met. Each instance is recorded in our internal system, and a CAPA is created which covers root-cause analysis, immediate corrective measures, preventive actions, and defined timelines.

Patients can report adverse events or other concerns through multiple channels, including their physician or nurse; MyVyvgartPath Nurse Case Managers (for enrolled, post-prescription U.S. patients); argenx patient-advocacy representatives; or via our website, email, phone, or social media.

Adverse events or quality issues at any stage of the product lifecycle—including clinical trials, pre-approval access, and post-marketing—are reported through various channels to Global Patient Safety and Global Quality. These reports are managed in accordance with pharmacovigilance regulations, guidelines, and internal quality procedures.

We assess our pharmacovigilance system through compliance monitoring and quality-management audits, evaluating product safety profiles and benefit-risk balance using all available data. The internal Benefit-Risk Committee reviews findings quarterly or as needed for each approved and investigational product.

Access to Medicines

MyVyvgartPath provides patients with education on insurance coverage, financial-assistance programs, commercial co-pay support, and expected out-of-pocket costs to help them navigate the complexities of the healthcare system in the United States.

We collaborate with distribution partners, healthcare systems, and payers to optimize supply chains and reduce access barriers, including formulary restrictions, unfavorable medical policies, new-to-market blocks, prior-authorization requirements, and step edits.

Market-specific affordability programs help us reach more patients and advance rare-disease care. In the United States, we participate in Medicare and Medicaid programs, which cap patient and manufacturer out-of-pocket contributions, and in the 340B program, which provides upfront product discounts to covered providers serving low-income communities.

Licensed physicians may request access to investigational medicines under development at argenx for patients with serious or immediately life-threatening conditions who are unable to participate in clinical trials or who have exhausted available treatment options. Unsolicited requests are reviewed in accordance with the Pre-Approval Access Policy, which governs all global requests.

Additionally, patients enrolled in argenx clinical trials may qualify for Post-Trial Access during temporary treatment gaps before medicines are approved or reimbursed in their country. The Post-Trial Access Program is managed by Medical Affairs and Evidence Generation under the oversight of the Chief Medical Officer.

Please refer to Section 1.7.4 "Coverage, Pricing and Reimbursement” and Section 1.7.5 “Government Pricing and Reimbursement Programs for Marketed Drugs in the U.S.” for additional information.

Innovation and R&D

Our Vision 2030 outlines our long-term ambition to transform the treatment for patients living with autoimmune diseases.

Please refer to Section 1.2.1 “Company’s Strategies” for additional information.

Targets

Our Vision 2030 aims to treat 50,000 patients with our medicines, achieve ten labeled indications across our approved medicines, and advance five pipeline candidates into Phase 3 development by 2030.

Please refer to Section 1.2.1 “Company’s Strategies” for additional information.

There are currently no targets in relation to access to quality information and responsible marketing, patient data privacy, patient health and safety, and access to medicines.

Metrics (MDR-M)

Legal Proceedings Relating to Ethical Marketing

Patients (S4) – Legal Proceedings Relating to Ethical Marketing

Metric

 

2025

 

2024

Total amount of monetary losses as a result of legal proceedings associated with false marketing claims

 

 

Data Privacy

Patients (S4) – Data Privacy

Metric

 

2025

 

2024

Number of data breaches that were detected within argenx that involved the exposure of sensitive patient information

 

2

 

Number of data breaches that were reportable to authorities or data subjects under applicable law

 

 

Patient Health and Safety

Patients (S4) – Patient Health and Safety

Metric

 

SASB Reference

 

2025

 

2024

Products listed in public medical product safety or adverse event alert databases.

 

HC-BP-250a.1

 

FDA: 1 product listed (efgartigimod)
EMA: 1 product listed (efgartigimod alfa)

 

Vyvgart is listed in the European Medicines Agency’s list of medicinal products under additional monitoring

Number of FDA safety notices

 

 

 

Number of recalls issued

 

HC-BP-250a.3

 

 

Number of inspections related to clinical trial management and pharmacovigilance that resulted in (1) entity voluntary remediation.

 

HC-BP-210a.2

 

 

Percentage of audits completed on vendors involved in manufacturing, testing and distribution of argenx products and product candidates.

 

 

92%

 

79%

Accounting Policies

The percentage of audits completed is based on 45 out of the planned 49 product quality audits being completed in 2025.

Access to Medicines

Patients (S4) – Access to Medicines

Metric

 

2025

 

2024

Number of patients approved for the gMG PAA program

 

11

 

70

Number of patient advocacy projects undertaken or organizations engaged with

 

39

 

45

Number of patients approved for the Post Trial Access program

 

5

 

N/A

Number of patients approved for the CIDP PAA program

 

45

 

N/A

Accounting Policies

The metrics for the gMG Pre-Approval Access (PAA), CIDP PAA, and Post-Trial Access (PTA) programs reflect the number of new patients approved and initiated on PAA or PTA treatment within the reporting period. In 2025, patient approvals for the gMG PAA program decreased following the global approval of gMG. A new gMG PAA program was launched in Australia to ensure ongoing access in a market without commercial availability. Metrics relating to the number of patients approved for the PTA and CIDP PAA programs were introduced in 2025; therefore, comparative information is not reported. The CIDP PAA program was launched in 2025.

The number of patient advocacy projects includes patient engagements such as patient panels, patient speakers, and fee-for-service engagements with international foundations (e.g., for CIDP launch activities). This does not include the number of patient advocacy organizations engaged with, patient events attended, or council meetings held.

Innovation and R&D

Patients (S4) – Innovation and R&D

Metric

 

SASB Code

 

2025

 

2024

Clinical trial patients treated with our own pipeline candidates in 2025

 

HC-BP-000.A

 

1,740

 

1,052

Number of drugs in research and development
(Phases 1–3)

 

HC-BP-000.B

 

7

 

3

Year-to-date R&D expense in line with our annual report (IFRS)

 

N/A

 

$ 1,364,132,000

 

$ 983,423,000

Number of Research and development employees

 

N/A

 

773

 

644

Active clinical trials

 

N/A

 

39

 

33

Accounting Policies

Clinical trial patients include all subjects effectively treated in our clinical trials. Any patient with at least one recorded IMP during the reporting period is counted. All participants are included regardless of treatment arm (placebo or active) or blinding status, and results are aggregated across routes of administration. Healthy volunteers are excluded.

The “Number of drugs in research and development (Phases 1–3)” includes argenx-nominated drug candidate programs in Phases 1, 2 or 3 and are not partnered. The number of R&D employees is disclosed in headcount, as of December 31, 2025. “Active clinical trials” includes all clinical trials that were active in 2025, including those that started (i.e., reached First Participant First Visit) and those that concluded (i.e., reached Last Participant Last Visit) during the year, and excludes observational clinical trials. Phase 1, 2 and 3 clinical trials only run in the period under review. Based on gADAM database, which starts from the gSDTM raw clinical data that we have available and that is refreshed regularly.