Annual Report 2024

Annual Report 2024

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Introduction to Workforce at argenx (ESRS 2 SBM-3)

Innovation is important to our business, and we see investing in our team as a significant aspect of driving innovation. We regard all our collaborators – whether employees (including contingent workers), independent consultants, or partners – as valuable to our company.

Talent Strategy, Management, and Development (S1-1, S1-3, S1-4, S1-5, S1-13, MDR-P, MDR-A, MDR-T)

Material S1 IROs described in this section.

  • Investments in employee learning and development through training programs foster employee well-being and prepares employees to meet future challenges while making them feel a greater sense of purpose and belonging (Impact).
  • A positive, diverse, and inclusive work environment that ensures equal treatment of all employees – regardless of origin, gender, sexual orientation, or religion – promotes fairness, and strengthens teamwork and collaboration (Impact).

argenx was founded on a model of co-creation and this core element of our entrepreneurial spirit remains widespread across the organization today, underpinning every step of our drug discovery, R&D, and commercialization processes. We aim to make everyone feel valued and empowered to reach our goals together with the objective to create an environment where our talent aligns with our mission, shares ownership of achievements, and contributes to our growth. Several functions, including human resources, legal & compliance, and our communications team, are dedicated to supporting our approach to talent at argenx. That being so, all of our initiatives are reviewed to ensure compliance with local laws, and individual decisions are always based on merit, consistent with applicable laws.

Talent Development (S1-13)

We work to create a workplace environment in which employees are equipped and empowered to do their best, while also having the support and resources to continue developing. To promote this continuous development, we offer formal leadership programs, development plans, and access to learning resources that help employees grow and advance their skills.

Our Managing Training standard operating procedure outlines the training opportunities at argenx to guide how training is managed at argenx and provides a framework for how training is assigned. The policy refers to the roles of employees in ensuring trainings are distributed and conducted. This applies to all our employees, consultants, interns, and contractors. The Head of Quality is accountable, with support from the Quality team.

We are committed to empowering our employees to reach their full potential through a personalized approach to development. Our employees are strongly encouraged to initiate a Personal Development Plan (PDP), which is designed to guide them on a strength-based development journey. This plan is paired with an e-learning program, offering educational materials tailored to their role and individual development objectives. In 2024, 99% of employees who opted into the program completed their e-learning courses.

We focus on developing leaders that understand the complexities of our business and will lead our teams in line with our Cultural Pillars. To help our current and future leaders advance their skills, we have developed the following leadership-focused programs:

  • Essentials Leadership Development Program: In 2024, 76 employees participated in the Essentials Leadership Development Program.
  • Emerging Leadership Development Program: In 2024, we launched three cohorts with a total of 40 participants.
  • LEAD: In 2024, 15 employees participated in the program, participating in summits and capstone projects.

We monitor the effectiveness of these programs through participant surveys.

We recognize that feedback is essential for employee development and continuous growth. Employees are encouraged to give and request feedback continuously throughout the year, rather than relying on an annual review process. We provide training to help teams understand how to give feedback following a Situation-Behavior-Impact (SBI) feedback model.

For more information on our policies and procedures related to employee feedback channels, visit the Governance section of this statement.

Employee Engagement (ESRS 2 SBM-2, S1-2)

Our engagement with employees occurs through direct and open forums, including dialogue sessions, focus groups, quarterly company-wide meetings, CEO introduction meetings and new hire check-ins, as detailed below.

  • Employees are invited to submit questions in advance to shape the agendas of our quarterly Company Wide Meeting “the Corporate Update” and invited to ask questions live during the Q&A portion of the meeting.
  • We have built a network of 44 employee ‘culture champions’ who host cultural dialogue sessions on an ongoing basis (employees can sign-up), this network includes both colleagues who have been nominated or have volunteered, the input from these sessions is used to shape employee programs and help guide leadership discussions around areas of opportunity to for employee engagement.
  • We have established office and campus site teams that host focus groups quarterly on various topics (wellbeing, development, and other offerings) to help shape offerings and discuss topics of interest.
  • New hire check-ins are hosted by members of the HR team following the first three months.

We also engage employees through various ongoing communication channels, including our internal social networking site ‘Engage’ where all employees are invited to share thoughts, ideas and ask questions. Additionally, the Employee Communications team shares company-wide news weekly and shares a monthly ‘In Case You Missed It’ email covering key updates. To ensure employees are aware of key updates, employees receive a corresponding email every time we issue a press release.

To assess the effectiveness of employee engagement, we use different forums to gather feedback, including through Focus group discussions and in the questions and comments submitted by employees ahead of our quarterly Corporate Update meetings. We also analyze how employees engage with content posted on our communication channels. argenx does not currently have a separate process to gain insight into the perspectives of particularly vulnerable groups or employees.

Human Rights (S1-1)

We endeavor to comply with international labor standards and applicable labor and employment laws in every region where we operate. 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 do not have a policy or program that manages impacts related to human rights. We engage with third parties who align with our values and endeavour to not conduct business with any individual or organization that participates in activities we prohibit.

In 2024, we had no severe human rights issues and incidents. We also did not incur any material fines, penalties, and compensation for severe human rights issues and incidents connected to own workforce.

Anti-Discrimination (S1-1, S1-17)

We uphold the right to freedom of association and maintain zero tolerance for workplace discrimination.

Our Code of Conduct and Business Ethics outlines our policies for preventing discrimination, including but not limited to race, religion, color, political convictions, sex, language, pregnancy, ethnic or national origin, civil state, social status, sexual orientation, handicap, or age. Additionally, our workforce policies apply to all employees and non-employees. In 2024, we did not incur any fines, penalties, or compensation for damages as a result of the incidents and complaints related to discrimination. That being so, all of our initiatives are reviewed to ensure compliance with local laws, and individual decisions are always based on merit, consistent with applicable laws.

Our anti-retaliation policy strictly prohibits any form of discrimination against employees who raise complaints. For more details on our anti-retaliation policies and procedures, as well as how we enable employees to speak up, visit the Governance section of this statement.

In our ongoing commitment to maintaining a safe workplace, our organization experienced the reporting of eleven incidents alleging discrimination or harassment within our workforce in 2024. Each incident was reviewed and/or formally investigated and addressed. There have been no substantiated findings of unlawful discrimination or harassment as a result. Regardless, argenx will continue to foster a respectful environment for all employees.

Inclusion (S1-1)

Pursuant to the required disclosure under ESRS S1-1, para 17, we disclose that in 2022, we adopted our Diversity, Equity and Inclusion policy, which outlines our approach to our workforce, which supports our ability to achieve our strategic goals. With our policy, we aim to have 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 while also complying 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). The policy is applicable to our global operations and is overseen by our Head of HR and General Counsel.

To promote an inclusive recruitment process we follow a standardized process across the organization. Our personal development program is aimed at building on individuals’ strengths to benefit the broader team. We focus promotion, training, and career-development solely on job-related criteria such as skills. Our employee resource groups also support the objectives of our policy through programming that promotes dialogue around how to further advance inclusion.

Our Employee Data

In 2024, the total number of employees by headcount was 1,599. During the reporting period, 96 employees left the company and we hired 524 new employees. Our turnover rate in 2024 was 6.7%, calculated using average headcount as the denominator. We have used our internal employee database, Workday, to compile the data. To learn more about our employee data, see Note 20 Personnel Expenses” within this annual report.

Training and Skills Development Metrics (S1-13)

argenx has applied transitional relief in respect of ESRS S1-13 for the first year of preparation of its Sustainability Statement.

Characteristics of employees in our workforce (S1-6)

Employee headcount by gender

Employee headcount by gender

Gender

 

Number of employees (Head count)

 

Percentage

Female

 

957

 

59.8

Male

 

642

 

40.2

(Note: Not reported signifies when employees have not made a selection)

Employee headcount in countries with at least fifty employees

Employee headcount in countries with at least fifty employees

Country

 

Number of Employees (Head Count)

Belgium

 

466

Japan

 

139

United States

 

694

Other

 

300

Total

 

1,599

(Note: Entities with fewer than 50 employees are consolidated and categorized as "others.")

Information on employees by contract type, broken down by gender (head count)

Information on employees by contract type, broken down by gender (head count)

Metric

 

Female

 

Male

 

Other

 

Not reported

 

Total

Number of employees

 

957

 

642

 

 

 

1,599

Number of permanent employees

 

956

 

641

 

 

 

1,597

Number of temporary employees

 

1

 

1

 

 

 

2

Number of non-guaranteed hours employees

 

 

 

 

 

Age Distribution Across Our Workforce (S1-9)

Age Distribution Across Our Workforce (S1-9)

Age Group

 

Number of Employees (Head Count)

Under 30 years old

 

95

30-50 years old

 

982

Over 50 years old

 

522

Total

 

1,599

Gender Distribution of Top Management (S1-9)

Gender Distribution of Top Management (S1-9)

Gender

 

Number

 

Percentage

Female

 

28

 

49.1

Male

 

24

 

42.1

Not reported

 

 

Other

 

5

 

8.8

Total

 

57

 

100.0

Note: Top management refers to the leadership team which is comprised of: the senior management team, major global and commercial leaders, major development project leaders, and key R&D leaders. ‘Other’ refers to vacant positions at top management level.

Characteristics of non-employees in the workforce (S1-7)

argenx has applied transitional relief in respect of S1-7 for the first year of preparation of its sustainability statement.

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

The remuneration ratio above is defined under ESRS and is presented differently under the Remuneration and Compensation report included in the Corporate Governance Chapter in Section 3 of this Annual Report. The figure for 2024 is 22.9.

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 -6.0 % to +1 % with a weighted average of 5.4 % in favor of women, reflecting our commitment and continuous monitoring of the core principles as laid out above.

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

Level

 

Gender Pay Gap

Individual Contributors

 

(5.1%)

Managers

 

(6.0%)

Directors

 

(5.6%)

Vice-Presidents

 

1.0%

Executives excluding CEO

 

(2.7%)

Weighted average gender pay gap

 

(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 2024 would be 18%, as calculated under ESRS.

Introduction to Patients at argenx (ESRS 2 SBM-3)

Driven by patient determination to overcome chronic disease challenges, we innovate for individuals with severe autoimmune diseases. We aim to advance autoimmune disease understanding and deliver transformative treatments globally by pioneering immunology innovations and understanding patient needs.

Patient Health & Safety (S4-1, S4-2, S4-3, S4-4, S4-5, MDR-P, MDR-A, MDR-T)

Material S4 IROs described in this section include:

  • Inability to ensure the safety of clinical trial participants and patients can have severe impacts on users’ health condition (Impact).
  • Risk of reputational damage from clinical trials’ or patients’ claims because of adverse events observed during clinical trials, including unforeseen reactions, if not appropriately addressed (Risk).

Patient health and safety are important to argenx at all stages of the product lifecycle. Due to the involvement in clinical trials and the marketing of medicinal products, we adhere to the worldwide pharmacovigilance regulations and guidelines to promote patient safety. Patient health and safety at argenx are managed through the Global Patient Safety Policy and a series of processes detailed in specific control documents, such as standard operating procedures and work instructions. The Chief Medical Officer is ultimately accountable for the implementation of this policy.

The Global Patient Safety Policy includes the following commitments:

  • Prevent and mitigate any harm arising from the use of argenx products.
  • Protect individual and public health based on comprehensive medical and scientific analyses of available safety information.
  • Conduct patient safety activities and responsibilities in compliance with legal and regulatory requirements.
  • Transparently communicate significant safety findings that impact the benefit-risk balance of argenx products to all applicable parties (e.g., health authorities, patients, and healthcare providers).
  • Have an adequate number of dedicated resources, processes, equipment, and systems in place for the timely assessment and escalation of safety issues and submissions of safety reports and/or safety information to health authorities.
  • Ensure that applicable third parties are made aware of and are compliant with their adverse event reporting obligations.
  • Instruct all internal and external parties to report safety information (i.e., adverse events within 24 hours or no later than one business day).
  • Advance argenx’s pharmacovigilance capabilities using new or evolving technologies in data science and computing.

Our procedures to safeguard patient health and safety globally, in line with the worldwide pharmacovigilance regulations and standards, include:

  • Collecting and reporting patient adverse events.
  • Conducting signal detection, which is a set of activities that identifies safety signals and evaluates the potential associations between medicinal products and adverse events and making the appropriate recommendations.
  • Characterizing the risks based on accumulated safety data and making the update to the risk management plans when warranted.
  • Preparing aggregate safety analyses for submission to authorities.
  • Providing accurate product information to prescribers and patients, reflecting the safety profile, and including any necessary mitigation measures.
  • Maintaining transparent communication with prescribers and patients regarding safety issues.

We do not have specific goals or targets related to patient health and safety. However, we monitor the safety of our products through metrics, including the metrics listed in the Drug Safety table below, which are reviewed regularly. There were no enforcement actions taken in response to violations of GMP or equivalent standards Preventive and corrective actions are implemented when defined thresholds are not met. Each instance is recorded in our internal system, and a CAPA (Corrective Action; Preventive Action) is created. This CAPA outlines immediate corrective measures, root cause investigation, and future preventive steps to avoid recurrence. Timelines for the CAPA are provided to support immediate correction of the issue and another timeline is provided for preventative activities.

In 2024, we did not receive any FDA Safety Notices, had no units recalled, and issued no recalls.

Patient Health & Safety – Metrics

Metric description

 

SASB Reference

 

Value

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

 

HC-BP-250a.1

 

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

Number of fatalities associated with products.

 

HC-BP-250a.2

 

Number of FDA safety notices

 

N/A

 

Remediation Processes and Consumer Feedback Channels

Patients can report adverse events or other concerns through various channels. These include informing their physician or nurse, contacting MyVyvgartPath Nurse Case Managers (for enrolled, post-prescription patients in the US only), or reaching out to patient advocacy representatives (argenx employees). Reports can also be made via our website, other monitored websites, email, phone, or social media.

For information on our approach to anti-retaliation and whistleblower protections, see the Governance section of this Sustainability Statement.

Information on adverse events or quality issues occurring at any stage of the product lifecycle (including clinical trials, Pre-Approval Access, and post-marketing) are reported through various communication channels to Global Patient Safety and Global Quality. These reports are managed in accordance with the worldwide pharmacovigilance regulations, guidelines, and quality procedures.

For US patients enrolled in the MyVyvgartPath post-prescription patient support program, discussions about symptoms and patient experiences are conducted. Our nurse case managers are trained to identify and report adverse events and product quality issues on behalf of the patient.

We aim to follow up on all reports of suspected adverse events in a timely and appropriate manner. A set of processes is in place to manage reported adverse events in compliance with pharmacovigilance regulations and standards. argenx regularly monitors received safety information and assesses whether the safety information and mitigation measures included in the product information are adequate or require updates. Additionally, further minimization measures beyond the product information are considered if necessary.

We evaluate the performance and effectiveness of our pharmacovigilance systems through various activities, such as compliance monitoring and quality management system audits. We closely monitor the safety profile and risk-benefit balance of its products incorporating all available data. This includes reviews occurring approximately quarterly and as needed by the internal Benefit-Risk Committee for each approved and investigational product, as well as a multidisciplinary labeling working group and a Global Labeling Committee. All findings are documented, with progress reported on and monitored in subsequent meetings. The Benefit-Risk Committee and Global Labeling Committee are comprised of senior representatives from all relevant functions.

Access to Quality Information & Responsible Marketing (S4-1, S4-2, S4-3, S4-4, S4-5, MDR-P, MDR-A, MDR-T)

Material S4 IROs described in this section include:

  • Misleading or inaccurate information relating to products can lead to improper use, including dangerous interactions with other medications or incorrect usage and dosage (Impact).
  • Off-label promotion exposes pharmaceutical companies to legal, financial, and reputational risks, inviting regulatory scrutiny and liability (Risk).
  • Risk of product misinformation and false claims can result in a loss of support from stakeholders (i.e., patients, doctors, pharmacists), non-compliance, significant fines, and settlements (Risk).

Our Code of Conduct and Business Ethics governs the promotion of our products, complying with all applicable laws, regulations, and ethical standards. All marketing and promotional activities must align with approved product indications and regulatory guidelines. Our Global Commercial Materials and Medical Education Materials Review Committee policy addresses our responsible marketing practices and access to appropriate scientific information, including prohibiting off-label promotion of medicines. Through this policy, we require product promotional communications and medical educational materials to undergo an internal review process by the relevant Materials Review Committee (MRC) or Medical Materials Review Committee (MMRC) before they can be used. Each review committee consists of personnel from multiple functions, namely Medical, Legal, and Regulatory, and ensures our external communications about our products and therapeutic areas are accurate, truthful, non-misleading, consistent with product labeling where applicable, scientifically substantiated, and appropriately balanced between risks and benefits. While all our stakeholders are responsible for following the policy, the responsible heads of Regulatory, Legal, Marketing, and Medical Affairs per region oversee the implementation of the policy. In addition to the review process, Ethics and Compliance supports the implementation of the policy by providing training on how to use approved materials and messaging in a compliant way.

The Global Commercial Materials and Medical Education Materials Review Committee policy is designed to maintain ongoing compliance with applicable legal and regulatory requirements governing advertising, promotion, and scientific communications, making it challenging to track effectiveness quantitatively. We ensure that the review committee is comprised of highly qualified professionals with expertise in the relevant Legal, Regulatory, and Medical disciplines. There are currently no targets related to responsible marketing.

Patients may report concerns about marketing practices to state and federal regulatory authorities. Upon learning of such concerns, we would fully consider the allegations to determine whether any changes to the materials are warranted. The company can modify its communications on a voluntary basis at any time. Additionally, materials are typically approved for a limited time of use, after which they are re-reviewed to confirm that the information remains current, scientifically accurate, properly substantiated, and consistent with regulatory-approved labeling where applicable. As previously described, compliance monitoring and internal audits are conducted to maintain strict adherence and to avoid potential deviations.

In 2024, argenx did not incur any monetary losses as a result of legal proceedings related to ethical marketing.

Patient Advocacy (S4-2, MDR-A)

In 2024, the Patient Advocacy function, overseen by the Global Vice President of Patient Advocacy, was responsible for facilitating patient engagements. We collaborate with patient advocacy organizations worldwide that focus on rare diseases and marginalized communities. We have a global patient advocacy team for engaging with these communities.

Feedback from patients has led to various argenx-led advocacy actions and initiatives aimed at improving patient outcomes, including the following:

  • Disease education engagement through platforms such as MG-United and Shining Through CIDP websites in the United States, sharing content on disease awareness, lifestyle information, patient mentors, training modules, resources, guidance for newly diagnosed patients, and holistic health tips like recipes, exercise, and emotional wellness.
  • All United for MG, founded in 2023, raises awareness about gMG in Europe and strengthens patients’ and caregivers’ rights for improved quality of life, better care, and access to resources.
  • Podcast series “Untold Stories: Life with a Severe Autoimmune Condition,” designed to tell the stories of patients from underserved or marginalized communities who are living with a severe autoimmune condition.
  • Educational materials on the disease and treatment produced by argenx, provided to patients through their physicians and published on platforms such as access-by-registration websites for each of the three indications available in Japan.
Patient Advocacy

Metric description

 

Value

 

Note

Number of patient advocacy projects undertaken or organizations engaged with1)

 

45

 

1

1)

The number of patient advocacy projects includes patient panels as described in the “Patient Engagement” section below, and excludes broader patient advocacy projects.

Patients and Human Rights (S4-1, MDR-P)

We do not have specific policy related to patients beyond the general approach outlined in the Code of Conduct and Business Ethics. The argenx Code of Conduct and Business Ethics includes a provision on safeguarding the health and safety of study participants in clinical trials, including the protection of human rights. We are committed to the following:

  • Act ethically to protect the human rights, dignity, privacy, and personal information of individuals involved in research.
  • Obtain the appropriate informed consent from everyone taking part in an argenx-sponsored clinical trial.
  • Fully train clinical investigators and other site staff on relevant study protocols and other clinical trial requirements and routinely monitor clinical trial sites to ensure their compliance with these standards.

We adhere to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code of Conduct. This code outlines how member companies should interact with healthcare professionals, healthcare organizations, and patient organizations, ensuring the responsible promotion of medicinal products while upholding high ethical standards in their interactions.

We comply with all internationally accepted standards that apply to our clinical trials, including the ICH Guidelines for Good Clinical Practice and the ethical principles articulated in the Declaration of Helsinki, as well as applicable local laws and regulations.

Access to Medicines (S4-1, S4-3, S4-5, MDR-P)

Material S4 IROs described in this section include:

  • Increased and better access to products and services (including through affordable pricing) can improve health and longevity for more patients (Impact).
  • Increased and better access to medicines through improving commercial/distribution channels and improving the affordability and pricing may lead to a growth in market capacity (Opportunity).

We have a Pre-Approval Access Global policy, overseen by our Chief Medical Officer, which outlines the principles for Pre-Approval Access (PAA) for an unapproved product. The policy’s scope encompasses all global PPA requests and activities, including those conducted by partners contracted by argenx.

Our Post-Trial Access Policy governs our Post-Trial Access program, detailing the evaluation and approval process for Post Trial Access (PTA) to an investigational product. The policy applies to all PTA requests for investigational products from patients previously enrolled in an argenx clinical trial.

Our Global Pricing Committee Charter establishes the foundation for our pricing decisions and supports our commitment to serving patients while maintaining the ability to innovate. This includes bringing new products to market that meet medical and societal needs, while considering the impact of pricing decisions on external stakeholders, such as patients, providers, payers, and other healthcare system actors. The Global Pricing Committee is responsible for implementing the Global Pricing Committee charter.

To increase access to medicines, we have established a patient support program called MyVyvgartPath which assists with education and navigation of the complex insurance process in the United States. This program provides patients with education about insurance coverage, potential financial assistance programs, commercial co-pay support, and possible out-of-pocket costs.

We collaborate with distribution partners, healthcare systems and payers to optimize supply chains and reduce barriers to access (e.g., not having a product listed on formulary, unfavorable medical policies, new to market blocks, prior authorization requirements, and step edits). Initiatives, such as market-specific patient affordability programs, help argenx to reach more patients and improve global health outcomes in the rare disease space.

In the United States, we participate in Medicare and Medicaid programs which contributes to affordability as it involves a series of out-of-pocket caps for the patient and manufacturer contributions in Part D as mandated by the United States Government. We also participate in the 340B program, which provides upfront product discounts to covered entity healthcare providers serving low-income communities.

In cases where a patient has a life-threatening or serious condition for which a clinical trial is not an option, or the patient has exhausted all currently available treatment options, their licensed treating physician may request access to an investigational medicine under development at argenx. When reviewing an unsolicited request for treatment, we will consider providing access to investigational medicines through an argenx Pre-Approval Access program if the request meets all the requirements of the Pre-Approval Access Policy. Additionally, patients who are actively enrolled in an argenx clinical trial may qualify for Post-Trial Access if they will experience a temporary gap in treatment until the medication is approved and reimbursed in their country. The Post-Trial Access Program is managed by Medical Affairs and Evidence Generation, with the Chief Medical Officer overseeing the policy’s implementation.

Please refer to Section 1.7.4 “Coverage, Pricing and Reimbursement” for additional information regarding pricing and the uncertainty around the coverage and reimbursement status of or products and/or product candidates.

There are currently no targets in relation to access to medicines. At present, the effectiveness of these actions is not formally tracked.

Access to Medicines – Metrics

Metric description

 

SASB Reference

 

Value

 

Note

List of products on the WHO List of Prequalified Medicinal Products as part of its Prequalification of Medicines Programme (PQP).

 

HC-BP-240a.2

 

 

 

Number of patients approved for PAA for their gMG patients

 

N/A

 

70

 

1

Percentage change in: (1) list price and (2) net price of product with largest increase compared to previous reporting period

 

HC-BP-240b.3

 

(1) Percentage change in list price: 2%
(2) Percentage change in net price: 1%

 

2

Percentage change in: (1) weighted average list price and (2) weighted average net price across product portfolio compared to previous reporting period

 

HC-BP-240b.2

 

(1) Percentage change in weighted average list price: (1)%
(2) Percentage change in weighted average net price: (5)%

 

3

1)

The metric shows the number of new patients approved during 2024.

2)

The metric shows the annualized percentage change in list price and the name of the product with the largest increase in list price compared to the previous reporting period. The calculation includes countries that contribute to aggregate 95% of product net sales.

3)

The metric shows the annualized percentage change in the revenue-weighted average list price increase across all the entity’s products sold globally during the reporting period. The calculation includes countries that contribute to aggregate 95% of product net sales. The net price is based on all products in the Company’s global portfolio over the year, weighted based on sales made in the fiscal year.

Data Privacy (S4-1, S4-3, MDR-P, MDR-A, MDR-T)

Material S4 IROs described in this section include:

  • Exposing sensitive patient information risks fines and penalties, lawsuits, remediation costs and reputational damage (Risk).

Recognizing the importance of data privacy, we take steps to protect sensitive patient information and have implemented policies to enhance protection from both technical and organizational perspectives throughout the information lifecycle.

Regarding patient data, the Global Data Privacy Policy outlines data privacy principles and safeguards, the role of the Data Protection Officer (DPO), data security considerations for data subjects (including patients), and the collection and use of sensitive personal data. The DPO reports to the General Counsel and is responsible for the implementation of the Global Data Privacy Policy. Committees such as the Global Compliance Committee (GCC) and the Audit and Compliance Committee oversee the privacy program.

The 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).

From an organizational perspective, we have established internal teams, such as the Privacy Steering Committee, to keep the company’s privacy practices accurate and up to date throughout the organization. Additionally, specific teams are formed for particular occurrences, such as the Incident Response team, which addresses security incidents, including data breaches, to report and mitigate them as much as possible. Controls are in place for any vendor-owned assets that process personal information and are used for the benefit of argenx. This is managed through a Computerized System Impact Assessment, which may lead to a Data Protection Impact Assessment if the privacy risk is considered higher.

Additionally, we maintain a database of potential or actual data breaches where patient sensitive information might have been compromised. Over the past year, no data breaches were detected within argenx that involved the exposure of sensitive patient information. Where data breaches occurred, they were external, involving our vendors, and had limited impact. Due to their limited impact from a privacy perspective, none of these data breaches were reportable to authorities or data subjects under applicable law.

In 2025, we aim to further improve and optimize our data privacy and security readiness by minimizing data breaches through our internal organizational processes. To achieve this, we review, update, and enhance our current policies and procedures on a regular basis. The detection, notification, and overall management of security incidents and data breaches, as outlined in procedural documents such as the Security Incident Management and the Personal Data Breach Procedure, are kept up-to-date and aligned with current laws, regulations, and best practices. This includes meeting response and notification timeline requirements and implementing appropriate corrective and mitigation measures.

Moreover, we aim to exercise further control over our vendors’ technical and organizational measures to protect patient information. This includes updating contractual terms, such as Data Processing Agreements, and enhancing the overall management of third-party risk assessment. Vendor engagement questionnaires and validation processes are updated to include questions related to the vendors’ privacy and security practices.

There are no measurable targets for patient data privacy. However, the Global Compliance Committee team monitors the overall progress of the privacy action plan, meeting quarterly each year.

Patient Engagement (S4-2)

We are dedicated to improving the lives of people with severe autoimmune diseases by listening to patients, supporters, and advocacy communities, with the gathering of perspectives and insights as a key part of our strategy. This approach helps advance the understanding of rare diseases and aims to deliver new treatments to as many patients as possible. Patient advocacy approaches vary across regions to comply with local regulations.

In 2024, we engaged with patients through the following key channels, guiding argenx’s strategy and empowering patients:

  • Patient panels: Conducted 45 times in 2024, initiated by indication development teams to gather patient insights on clinical trial protocols, ICF reviews, patient journeys, and other clinical development needs
  • Multifocal Motor Neuropathy patient survey
  • Myasthenia Gravis Advocacy Leadership Council: Met once per quarter
  • Autoimmune round table: Developed in 2024 for non-MG groups, held three times in its inaugural year.
  • Annual Patient Summits: Bring patients together in person for focus groups, brainstorming, and keynote sessions.
  • Collaboration with national and regional patient advocacy groups: Share industry insights and best practices and align on priorities for the year ahead.
  • CIDP advisory board: Helps understand the burden of illness, real-world evidence from patients, and the societal impact of the disease across Europe.

In the United States, argenx engages directly with patients and their representatives on key topics such as health, safety, and market access throughout the product lifecycle. In Europe and other regions, argenx collaborates with third-party service providers, such as nurses, who have direct access to patients. These nurses are trained by argenx on disease and treatment protocols to help patients through their treatment journey and are involved in pharmacovigilance data collection. Patient engagement occurs at all stages of the product lifecycle, including with both clinical trial patients during development and with commercial patients before and after prescription.