Industry Specific Disclosures

Introduction to Industry Specific Disclosures

We are dedicated to upholding our standards of innovation, quality, and product safety in order to mitigate risks, accelerate scientific breakthroughs and provide high-quality, safe, and differentiated medicines.

Innovation

Material entity specific IROs described in this section include:

• Successful innovation helps find new treatments for current diseases and address unmet needs, allowing more patients to be treated (Impact).

Description of Innovation at argenx

We strive to innovate on behalf of patients, and we do this through a model of co-creation, combining our antibody-engineering capabilities with the expertise of leading disease biologists to address novel targets and develop innovative, first-in-class therapies.

While there are no formal policies or targets relating to innovation, our Vision 2030, which was announced at the R&D day in the summer of 2024, outlines our plans to transform the treatment of autoimmune diseases through a continuous pipeline of innovation. Through this vision, we aim to treat fifty thousand patients with our medicines, secure ten labeled indications across our approved medicines, and advance five pipeline candidates into Phase Three development by 2030.

To foster a continuous pipeline of innovation and achieve the goals outlined in our ‘Vision 2030’, argenx has set the following priorities for 2025:

• Expand the global VYVGART opportunity by reaching more patients broadly across MG, CIDP and ITP through additional regulatory approvals and continuous evidence generation.
• Launch VYVGART SC as a pre-filled syringe to innovate on the patient experience and move earlier in the MG and CIDP treatment paradigms.
• Execute ten registrational and ten proof-of-concept studies to fuel pipeline growth across efgartigimod, empasiprubart and ARGX-119.
• Advance four new molecules into Phase One development, expanding the next wave of innovation.
• Generate sustainable value through continued investment in the Immunology Innovation Program, focused on antibody-based medicines with pipeline-in-a-product potential.

We measure progress through a set of strategic priorities aligned with our overarching vision. Our focus on innovation helps us to find new treatments for severe autoimmune diseases, as demonstrated through VYVGART, empasiprubart, and our expanding pipeline of antibody-based therapeutics. This includes plans to advance our offerings around myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP), advance the next wave of indications through late-stage development to reach patients, and invest in bringing forward new pipeline candidates.

Our innovative efforts have resulted in the continuous development of drug candidates and a cadence of wholly owned argenx-nominated programs into our portfolio.

Product Quality

Material entity specific IROs described in this section include:

• Poor product quality can directly impact the effectiveness of treatments and overall health of patients (Impact).

Description of Quality at argenx

Quality is a core value at argenx and drives our innovation by promoting consistency, reliability, and compliance throughout our processes. This commitment results in high standard products for patients. At argenx, quality is a shared responsibility, and we work together to make data-informed decisions for the benefit of patients worldwide. United in our commitment to improving the quality of life for patients, we deliver quality, safe, and life changing products.

Our Quality policy is a formal statement outlining our commitment to quality. It communicates senior management’s commitment and strategic intent regarding quality standards, compliance, and customer satisfaction. The Quality policy acts as a guiding principle for the organization, influencing decisions and behavior at all levels. This includes putting all procedures and processes in place to prevent, mitigate, and remediate poor product quality, directly impacting the effectiveness of treatments and overall health of patients.

The Quality policy sets out the following objectives:

• Champion a strong quality culture across the organization.
• Demonstrate strong and visible support for the quality management system and its implementation throughout the organization.
• Encourage participation in and promotion of quality responsibilities among all employees through consistent and effective communication.
• Establish and maintain processes to promote traceable, transparent, and trustworthy data, enabling product integrity and patient safety.
• Comply with applicable laws, quality regulations, standards, and internal requirements.
• Create an effective and qualitative oversight of any third party acting on behalf of argenx.
• Empower employees through continuous learning to achieve the required standards for excellent quality management and to elevate every employee to his/her highest potential.
• Foster a culture of continuous improvement and innovation where we challenge ourselves to increase the effectiveness of our processes and quality performance.

The Quality policy applies to all argenx internal and external activities related to research, development, preclinical development, clinical development, manufacturing, distribution, marketing, and commercialization of our products. It also covers oversight and appropriate monitoring controls of outsourced processes of third parties and collaborators such as manufacturing, distribution, preclinical trials, and collaborations. It is intended to ensure consistency, efficiency, reliability, compliance, data integrity, and ensures the health and safety of patients and the highest quality of products. The senior management team, including the Global Head of Quality, have overall accountability for the implementation of the policy.

We maintain quality control and assurance measures throughout the product lifecycle, from research and development to manufacturing and distribution, to secure the safety and efficacy of our products. By adhering to stringent regulatory requirements and continuously monitoring the performance of our manufacturing processes, we aim to minimize risks and enhance patient outcomes.

Actions on the respective policies are covered as part of the day-to-day operations in the Quality Management System. This is covered via the core quality processes, which cover aspects such as internal/external deviations, complaints, and Corrective Action and Preventative Action (CAPA) procedures. Corrective actions are actions that are performed after an investigation to correct the root cause of the deviation and to prevent a recurrence of the deviation. Preventive actions are actions that are performed to prevent deviation from happening. A Product Quality Complaint (PQC) is any written, electronic, or oral communication that contains potential defects related to identity, quality, purity, strength, durability, reliability, safety, effectiveness, or performance of a Product released for distribution or used in a clinical trial.

While no specific targets are currently in place for product quality, we track the effectiveness of our policies and procedures through the Quality Management Review (QMR) Process. The QMR is a key component of the quality management system(s) and provides a high level overview of the effectiveness and suitability of the quality management system within the organization that shows if expectations are being correctly anticipated, met and/or exceeded and processes are effective and in a state of control. It also plays a pivotal role in proactively identifying, scientifically evaluating, and controlling potential risk to quality.

In 2024, we had zero commercial product and clinical batch recalls and zero commercial supply stock outs. 15/25 (60%) CAPAs from Continuous Improvement and Quality Risk Management were preventive. Our original Annual Audit Plan for 2024 included 31 external audits for GMP/GDP, which includes audits executed at an argenx third party, performed by either an external auditor or an argenx employee trained as an auditor. During the year, our audit schedule was adjusted quarterly based on evolving needs, for example, as new vendors were identified during the year. Through this process to adjust our audit schedule, 11 additional external audits were added during the year. Of the total 42 external audits, 33 (79%) were completed in 2024 and in all cases, vendors continued to be qualified. The remaining audits were either re-prioritized, based on risk, to be addressed in future years or deemed no longer relevant if the vendor no longer provided services to argenx.

There were no inspections related to clinical trial management and pharmacovigilance that resulted in voluntary remediation or regulatory actions against the entity. All inspections passed without critical findings or FDA 483 OAIs.

We continuously monitor the safety profile of our investigational products and comply with adverse event reporting to health authorities worldwide. Additionally, we have maintained a consistent supply to patients in clinical trials, with no supply disruptions.

Product Traceability and Counterfeit Drugs

Material entity specific IROs described in this section include:

• A lack of product traceability and transparency can lead to counterfeit drugs or materials, endangering patient health (Impact).

Description of Product Traceability and Counterfeit Drugs at argenx

Product traceability is a crucial component of our mission and helps reinforce trust with stakeholders, particularly our patients. We are committed to maintaining the integrity and safety of our products through product traceability, anti-tampering, and counterfeit prevention mechanisms.

In compliance with national legislation (e.g., DSCSA in the U.S. and Falsified Medicines Directive (FMD) in the EU), all commercial argenx products are serialized at the unit, case, and pallet levels. Each sellable unit features a unique random serial number, product code, lot number, and expiration date, both in human-readable format and encoded in a 2D data matrix barcode. All products are tamper-evident sealed, and shipping systems and trucks are sealed with numbered seals during transit to prevent tampering.

Our EU Serialization Policy outlines the processes and procedures involved in the product lifecycle as it relates to our EU FMD serialization program. The policy applies to our Global Commercial Supply Chain, Commercial Product Quality, and EU Distribution and covers our pharmaceutical prescription product SKUs in the EU supply chain (EU-Falsified Medicines Directive participating markets, including EU 27, Northern Ireland, EEA, Switzerland). Our Head of Logistics Product Quality and EU RP are accountable for implementation of the policy.

Our US Serialization Policy outlines the process and procedures involved in the product lifecycle as it relates to our DSCSA serialization program. The policy applies to our Global Commercial Supply Chain, Commercial Quality, US Distribution, Business Information Systems (BIS) and Chemistry, Manufacturing and Controls (CMC), and covers our pharmaceutical prescription product SKUs in the US supply chain. The policy is reflected in the supplier responsibilities outlined in quality agreements and contracts. The Global Commercial Supply Chain is responsible for DSCSA Serialization Program implementation.

In Japan, traceability is addressed through mandatory GS1 Standard Barcodes which includes a GS1 Databar Limited Composite Symbol on packaging. This symbol includes product code (GTIN), expiration date, and lot number (batch number). This allows pharmacies and hospitals to check the authenticity of the drug.

During batch manufacturing (outsourced to CMOs), all processing steps are documented to have a full processing history and lot genealogy of consumed raw materials, which is also maintained in the CMO’s quality system. An ERP system is used to provide full lot genealogy and traceability of intermediates and finished products owned by argenx, located at its CMOs, third-party warehouses and third-party logistics providers (3PL). For downstream distribution, the entity can rely on the distributors and wholesalers’ systems to trace products to the end customer.

We also have procedures in place to mitigate the risk of falsified or counterfeit medicine. This includes a consistent reporting process for any suspicions of falsified or counterfeit products. When a case is reported, the impacted batches are separated and quarantined, an investigation is conducted, and the relevant stakeholders in the supply chain, as well as competent authorities, are informed in case of confirmed counterfeit products. Market actions are taken in consultation with competent authorities.

While no specific targets are currently in place, we track the effectiveness of our policies and procedures through an annual mock recall. This exercise tests the accuracy and efficiency of our recall process, including product traceability and responsiveness.

In 2024, we had no incidents of falsified or counterfeit medicine reported and no actions that led to raids, seizures, arrests, or criminal charges related to counterfeit products.

Product Traceability Metrics