Annual Report 2024

Annual Report 2024

Appendix

EU Legislation Data Points

EU List of datapoints in cross-cutting and topical standards that derive from other EU legislation

EU Legislation Data Points

Disclosure requirement

 

Data point

 

Description

 

Regulation

 

Section (state if not material)

ESRS 2 GOV-1

 

21 (d)

 

Board’s gender diversity

 

SFDR, Benchmark regulation

 

 

ESRS 2 GOV-1

 

21 (e)

 

Percentage of board members who are independent

 

Benchmark regulation

 

 

ESRS 2 GOV-4

 

30

 

Statement on sustainability due diligence

 

SFDR

 

 

ESRS 2 SBM-1

 

40 (d) i

 

Involvement in activities related to fossil fuel activities

 

SFDR, Pillar 3, Benchmark regulation

 

Not relevant

ESRS 2 SBM-1

 

40 (d) ii

 

Involvement in activities related to chemical production

 

SFDR, Benchmark regulation

 

Not relevant

ESRS 2 SBM-1

 

40 (d) iii

 

Involvement in activities related to controversial weapons

 

SFDR, Benchmark regulation

 

Not relevant

ESRS 2 SBM-1

 

40 (d) iv

 

Involvement in activities related to cultivation and production of tobacco

 

Benchmark regulation

 

Not relevant

ESRS E1-1

 

14

 

Transition plan to reach climate neutrality by 2050

 

EU Climate Law

 

 

ESRS E1-1

 

16 (g)

 

Undertakings excluded from Paris-aligned Benchmarks

 

Pillar 3, Benchmark regulation

 

 

ESRS E1-4

 

34

 

GHG emission reduction targets

 

SFDR, Pillar 3, Benchmark regulation

 

 

ESRS E1-5

 

38

 

Energy consumption from fossil sources disaggregated by sources (only high climate impact sectors)

 

SFDR

 

 

ESRS E1-5

 

37

 

Energy consumption and mix

 

SFDR

 

 

ESRS E1-5

 

40-43

 

Energy intensity associated with activities in high climate impact sectors

 

SFDR

 

 

ESRS E1-6

 

44

 

Gross Scope 1, 2, 3 and Total GHG emissions

 

SFDR, Pillar 3, Benchmark regulation

 

 

ESRS E1-6

 

53-55

 

Gross GHG emissions intensity

 

SFDR, Pillar 3, Benchmark regulation

 

 

ESRS E1-7

 

56

 

GHG removals and carbon credits

 

EU Climate Law

 

Not stated (phase-in)

ESRS E1-9

 

66

 

Exposure of the benchmark portfolio to climate-related physical risks

 

Benchmark regulation

 

 

ESRS E1-9

 

66 (a)

 

Disaggregation of monetary amounts by acute and chronic physical risk

 

Pillar 3

 

 

ESRS E1-9

 

66 (c)

 

Location of significant assets at material physical risk

 

Pillar 3

 

 

ESRS E1-9

 

67 (c)

 

Breakdown of the carrying value of its real estate assets by energy-efficiency classes

 

Pillar 3

 

 

ESRS E1-9

 

69

 

Degree of exposure of the portfolio to climate-related opportunities

 

Benchmark regulation

 

 

ESRS E2-4

 

28

 

Amount of each pollutant listed in Annex II of the E-PRTR Regulation emitted to air, water and soil

 

SFDR

 

 

ESRS E3-1

 

9

 

Water and marine resources

 

SFDR

 

Not material

ESRS E3-1

 

13

 

Dedicated policy

 

SFDR

 

Not material

ESRS E3-4

 

28 (c)

 

Total water recycled and reused paragraph

 

SFDR

 

Not material

ESRS E3-4

 

29

 

Total water consumption in m 3 per net revenue on own operations

 

SFDR

 

Not material

ESRS 2 SBM-3 – E4 paragraph 16 (a) i

 

16 (a) i

 

 

 

SFDR

 

Not material

ESRS 2 SBM-3 – E4 paragraph 16 (b)

 

16 (b)

 

 

 

SFDR

 

Not material

ESRS 2 SBM-3 – E4 paragraph 16 (c)

 

16 (c)

 

 

 

SFDR

 

Not material

ESRS E4-2

 

24 (b)

 

Sustainable land/agriculture practices or policies

 

SFDR

 

Not material

ESRS E4-2

 

24 (c)

 

Sustainable oceans/seas practices or policies

 

SFDR

 

Not material

ESRS E4-2

 

24 (d)

 

Policies to address deforestation

 

SFDR

 

Not material

ESRS 2 SBM3

 

14 (g)

 

Risk of incidents of child labour

 

SFDR

 

 

ESRS S1-1

 

20

 

Human rights policy commitments

 

SFDR

 

 

ESRS S1-1 21

 

21

 

Sustainability due diligence policies on issues addressed by the fundamental International Labor Organisation Conventions 1 to 8

 

Pillar 3

 

 

ESRS S1-1

 

22

 

Processes and measures for preventing trafficking in human beings

 

SFDR

 

 

ESRS S1-1

 

23

 

Workplace accident prevention policy or management system

 

SFDR

 

 

ESRS S1-3

 

32 (c)

 

Grievance/complaints handling mechanisms

 

SFDR

 

 

ESRS S1-14

 

88 (b), (c)

 

Number of fatalities and number and rate of work-related accidents

 

SFDR, Pillar 3

 

 

ESRS S1-14

 

88 (e)

 

Number of days lost to injuries, accidents, fatalities or illness

 

SFDR

 

 

ESRS S1-16

 

97 (a)

 

Unadjusted gender pay gap

 

SFDR, Pillar 3

 

 

ESRS S1-16

 

97 (b)

 

Excessive CEO pay ratio

 

SFDR

 

 

ESRS S1-17

 

103 (a)

 

Incidents of discrimination

 

SFDR

 

 

ESRS S1-17

 

104 (a)

 

Non-respect of UNGPs on Business and Human Rights and OECD Guidelines

 

SFDR, Benchmark regulation

 

 

ESRS 2 SBM-3 – S2

 

11 (b)

 

Significant risk of child labour or forced labour in the value chain

 

SFDR

 

Not material

ESRS S2-1

 

17

 

Human rights policy commitments

 

SFDR

 

Not material

ESRS S2-1

 

18

 

Policies related to value chain workers

 

SFDR

 

Not material

ESRS S2-1 Non-respect of UNGPs on Business and Human Rights principles and OECD guidelines paragraph 19

 

19

 

Non-respect of UNGPs on Business and Human Rights principles and OECD guidelines

 

SFDR, Benchmark regulation

 

Not material

ESRS S2-1

 

19

 

Due diligence policies on issues addressed by the fundamental International Labor Organisation Conventions 1 to 8

 

Benchmark regulation

 

Not material

ESRS S2-4

 

36

 

Human rights issues and incidents connected to its upstream and downstream value chain

 

SFDR

 

Not material

ESRS S3-1

 

16

 

Human rights policy commitments

 

SFDR

 

Not material

ESRS S3-1

 

17

 

Non-respect of UNGPs on Business and Human Rights, ILO principles or OECD guidelines

 

SFDR, Benchmark regulation

 

Not material

ESRS S3-4

 

36

 

Human rights issues and incidents

 

SFDR

 

Not material

ESRS S4-1

 

16

 

Policies related to consumers and end-users

 

SFDR

 

 

ESRS S4-1

 

17

 

Non-respect of UNGPs on Business and Human Rights and OECD guidelines

 

SFDR, Benchmark regulation

 

 

ESRS S4-4

 

35

 

Human rights issues and incidents

 

SFDR

 

 

ESRS G1-1

 

10 (b)

 

United Nations Convention against Corruption

 

SFDR

 

 

ESRS G1-1

 

10 (d)

 

Protection of whistleblowers

 

SFDR

 

 

ESRS G1-4

 

24 (a)

 

Fines for violation of anti-corruption and anti-bribery laws

 

SFDR, Benchmark regulation

 

 

ESRS G1-4

 

24 (b)

 

Standards of anti-corruption and anti-bribery

 

SFDR

 

 

SASB

SASB Table

SASB

SASB Reference

 

Metric description

 

argenx response

HC-BP-000.A

 

Number of clinical trial patients treated.

 

1,052

HC-BP-000.B

 

Number of drugs in research and development (Phase 1-3).

 

3
(Phase 1: 0
Phase 2: 2
Phase 3: 1)

HC-BP-000.B

 

Number of drugs in portfolio.

 

7

HC-BP-210a.1

 

Discussion, by region, of management process for ensuring quality and patient safety during clinical trials.

 

We ensured the continuous monitoring of the safety profile of our investigational products and ensured compliance with adverse event reporting to health authorities worldwide. We also ensured supply to patients on clinical trials and have had no supply disruption.

HC-BP-210a.2

 

Number of inspections related to clinical trial management and pharmacovigilance that resulted in (2) regulatory or administrative actions taken against the entity.

 

0

HC-BP-210a.2

 

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

 

0

HC-BP-240a.2

 

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

 

0

HC-BP-250a.1

 

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

 

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

HC-BP-250a.2

 

Number of fatalities associated with products.

 

0

HC-BP-250a.3

 

(2) Total units recalled.

 

0

HC-BP-250a.3

 

(1) Number of recalls issued.

 

0

HC-BP-250a.4

 

Total amount of product accepted for takeback, reuse, or disposal.

 

0.051

HC-BP-250a.5

 

Number of enforcement actions taken in response to violations of good manufacturing practices (GMP) or equivalent standards, by type.

 

0

HC-BP-260a.1

 

Description of methods and technologies used to maintain traceability of products throughout the supply chain and prevent counterfeiting.

 

To the extent this is required by national legislation (e.g. DSCSA in U.S. and FMD in EU), all commercial argenx products are serialized at unit, case and pallet (aggregated level). On each sellable unit a unique random serial number is printed as well as a 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 product tampering. 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 3PL. For downstream distribution, the entity can rely on the distributors and wholesaler’s systems to trace product to the end customer.

A yearly mock up recall also takes place for which traceability is tested.

argenx has a procedure in place to ensure that all suspicions of falsified or counterfeit medicine are reported in a consistent manner. When a case is reported, the impacted batches will be separated and quarantined, an investigation will be performed and the impacted stakeholders in the supply chain will be informed, as well as the relevant competent authorities in case of confirmed counterfeit product. Market actions will be taken in consultation with the competent authority.

HC-BP-260a.2

 

Discussion of process for alerting customers and business partners to potential or known risks associated with counterfeit products.

 

argenx has a procedure in place to ensure that all suspicions of falsified or counterfeit medicine are reported in a consistent manner. When a case is reported, the impacted batches will be separated and quarantined, an investigation will be performed and the impacted stakeholders in the supply chain will be informed, as well as the relevant competent authorities in case of confirmed counterfeit product. Market actions will be taken in consultation with the competent authority.

HC-BP-260a.3

 

Number of actions that led to raids, seizure, arrests, or filing of criminal charges related to counterfeit products.

 

0

HC-BP-270a.1

 

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

 

No monetary losses as a result of legal proceedings. No documentation to provide as there were no losses.

HC-BP-270a.2

 

Description of code of ethics governing promotion of off-label use of products.

 

argenx’s Code of Ethics and related policies strictly govern the promotion of its products, ensuring compliance with all applicable laws, regulations, and ethical standards. It explicitly prohibits the promotion of off-label use of products. All marketing and promotional activities must align with approved product indications and regulatory guidelines.

HC-BP-330a.1

 

Discussion of talent recruitment and retention efforts for scientists and research and development staff.

 

Talent Attraction
argenx takes a value- and team-based approach to talent acquisition. This means we not only prioritize the requisite knowledge and skills when hiring, but also seek alignment with our cultural pillars to strengthen the organization. In other words, we hire for attitude and train for skill. This commitment to building cohesive and value-driven teams is essential for fostering innovation and sustainability. Recognizing the importance of diversity in our global teams, we actively seek the greatest talent from around the world. Our leaders’ continuous commitment helps us to attract the brightest minds with equally collaborative spirits, in every function from R&D to legal. All argonauts serve as ambassadors of our culture, which is the best recruiting tool to rely on the broad network of our veteran teams. This approach helps to ensure that our workforce reflects the global nature of the biotech industry and brings diverse perspectives to drive our innovation forward.

Employee Development & Retention
We know our mission is a large part of why people choose to work at argenx; we also know that our mission alone will not keep top talent satisfied forever. We draw on our cultural pillars of innovation, co-creation, empowerment, excellence and humility to create an environment in which argonauts not only do their best – their best can become even better. The scientific breakthroughs we pursue on behalf of patients do not happen quickly – it can take years of research to bring an effective therapy to market. As a result, we need argenx to be a place where people want to work for the long-term, and where they can continue to grow their skills and impact over time. Throughout 2024, we deepened several initiatives to cultivate our team’s leadership skills while living up to our values.
-Essentials Leadership Development Program: We aim to help all rising leaders appreciate the full complexities of the biotech business and how we can continue to improve decision-making across the company.
- Personal Development Plans (PDP): One of our core operating principles is that we develop our business by developing our people. It’s critical that argonauts share a continuous growth mindset in pursuit of innovation, which means we must attract people who want to take on new challenges. We take a strengths-based approach to PDPs that allows argonauts to flex and grow within their current roles, while opening doors to new roles with new experiences on their argenx journey. 99% of our people completed the PDP e-learning.
- Feedback training based on SBI (Situation Behaviour Impact) was launched in 2024. 76% of argonauts were trained.
- Communications Council: To live up to our promise of “one company, one purpose,” we bring together argonauts spanning teams, management levels and geographies on our Communications Council. This group embodies our spirit of co-creation and collaboration by reviewing company-wide internal communication as well as social media programs and provides a channel for candid feedback and conversation.
- Culture Labs: We also bring argonauts together for in-person and virtual Culture Lab sessions. In 2024, 1246 argonauts took part in at least one of these sessions to deepen our collective understanding of our cultural pillars. Our goal is to continue scaling and extending with a focus on our Operating Principles and on Innovation.

HC-BP-510a.1

 

Total amount of monetary losses as a result of legal proceedings associated with corruption and bribery.

 

0

HC-BP-510a.2

 

Description of code of ethics governing interactions with health care professionals.

 

argenx’s Code of Ethics governs interactions with healthcare professionals (HCPs) to ensure compliance with all applicable laws, regulations, and ethical standards. The code requires that all engagements with HCPs are conducted with transparency, integrity, and respect for their independence. It prohibits any improper influence or incentives, ensuring that decisions regarding patient care remain unbiased and in the best interest of patients. Interactions are guided by policies such as the Interactions with HCC Policy, which includes provisions on fair market value compensation for services, appropriate documentation, and adherence to anti-bribery and anti-corruption laws. Training programs, regular monitoring, and internal audits reinforce these standards.

HC-BP-240b.3

 

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

 

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

HC-BP-240b.2

 

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

 

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