CLINUVEL acknowledges the importance of an integrated and consistent approach to the
management of Environmental, Social and Governance (ESG) risks and strives to improve all aspects of responsibility for positive outcomes, year on year.
| Social | Environmental | Governance |
|---|---|---|
| Fairness and Equity | Conscious of our World | Responsibility and Compliance |
| Human rights | Recognise climate change | Honesty and integrity |
| Freedom of association | Energy management | Corporate governance |
| Equal opportunity | Safe and responsible materials handling | Compliance |
| Value diversity | No adverse impact on global objectives | Ethics |
| Work-life balance | Supplier standards | Supplier standards |
| Training and education | ||
| Supplier standards |
The Company’s values (outlined on pages 10–11) underpin the practices of the Company and its employees and align to key ESG tenets.
CLINUVEL adheres to the United Nations (UN) Global Compact ten principles of sustainability which cover human rights, labour standards, the environment, and anti-corruption.
CLINUVEL is conscious of the impact of the activities of humanity on the environment and takes a responsible approach to managing its impact on the environment.
CLINUVEL embraces the UN definition of sustainability to meet the needs of the present without compromising the ability of future generations to meet their own needs. Currently, CLINUVEL’s activities are conducted by a workforce of about 100 and the Company does not manufacture its products. The direct impact of CLINUVEL’s activities on the environment is therefore assessed as low. Reflecting this, CLINUVEL’s current focus is on qualitative initiatives to manage its impact on the environment.
Management is accountable to ensure environmental responsibility across all activities and specifically:
We are committed to reducing our operational waste and our recycling program is being enhanced by moving towards paperless processes in our operational functions.
With regard to product packaging, CLINUVEL adheres to the environmental standards expected of cosmetic products in the European countries of distribution of CYACÊLLE. In France, for example, CLINUVEL is a member of CITEO which adheres to the principle of Extended Producer Responsibility for household paper and packaging to minimise the waste products produce. A positive start has been made as the primary and secondary product packaging of CYACÊLLE is glass and carton, respectively, and only the cap is made of plastic.
In addition to these initiatives, a split home / office working week in most locations serves to minimise the carbon footprint of employees. Furthermore, employees do not travel frequently to see stakeholders in person and responsibility is vested in senior management to review and approve travel within countries of operation and internationally, to ensure sufficient tangible benefits are realised.
Quantitative measures or metricated targets are not set at this time but will be assessed and introduced as the scale and size of the business increases in the future. Given its low environmental impact, CLINUVEL has received support for this approach from a range of investors, including those institutions with an ESG focus.
Currently, CLINUVEL will be required to prepare a Sustainability Report in accordance with AASB 2 Climate- Related Disclosures from 1 July 2027. CLINUVEL is working towards implementing appropriate processes and internal controls over sustainability information by this date.
CLINUVEL’s key social contribution is the development and distribution of products for unmet patient and healthcare needs.
The paramount focus of CLINUVEL in terms of social responsibility is on the safety of its products and the wellbeing of patients and personnel.
We ensure our products are safe for human use through thorough research and the minimum non-clinical and clinical studies necessary to ensure safety of our products and obtain regulatory approvals of pharmaceutical products in respective jurisdictions. CLINUVEL is committed to the OECD Replacement Reduction and Refinement Principles for non-human studies and ensures all studies undertaken are responsibly designed and conducted by laboratories certified by internationally recognised and respected bodies.
We use ethics committees for study approval, adhere to OECD Testing Guidelines and the principles of GLP.
We ensure the manufacture of goods and distribution of materials and products are undertaken responsibly and ethically. CLINUVEL works with key suppliers that adhere to global regulatory standards (including GLP and GMP) to ensure the quality of its products.
Afamelanotide, the active pharmaceutical ingredient in SCENESSE® and other products, has a positive safety record from over 20,500 administrations for commercial, clinical, and compassionate uses over more than one and a half decades. A rigorous pharmacovigilance program is also maintained and reported to global regulatory authorities to confirm the real-world experience treating adult erythropoietic protoporphyria (EPP) patients with SCENESSE® (afamelanotide 16mg).
Reflecting CLINUVEL’s social commitment, SCENESSE® (afamelanotide) was successfully administered during FY2025 to a 9-year-old girl living with severe symptoms of erythropoietic protoporphyria (EPP). The child was suffering from severe phototoxicity and was going through an ordeal preventing her from participating in daily activities. She was living indoors and could not tolerate any form of light. Following treatment, she is now leading a more normal life, including returning to school.
SCENESSE® is approved for the prevention of phototoxicity in adult EPP patients. Since 2021, adolescent EPP patients have received treatment in European EPP Expert Centres, with the treatment reimbursed by insurance companies. Several adolescent patients remain on treatment today.
CLINUVEL respects the human rights of employees and freedom of association and exceeds the minimum labour standards expected of an employer. The Company’s focus is to provide employees with 1) a safe, positive, and flexible working environment to support wellbeing, active interaction and productivity, and 2) competitive performance-based remuneration and employment benefits that enable financial independence and acceptable living standards.
In addition, CLINUVEL recognises the importance of, and provides the opportunity for, positive career development, ensuring succession planning rewards performance and endeavour. This is achieved through Individual Development Plans for all employees and advanced development through the CLINUVEL Academy.
Reflecting the safe working environment provided, there were no injuries or time lost from workplace accidents in FY2025 (Nil in FY2024).
CLINUVEL respects and promotes diversity across our entire workforce and recognises that a diverse workforce contributes to innovation, change and the long-term growth of our business.
CLINUVEL is committed to equality of opportunity which applies to all human beings regardless of gender and gender identification, sexual orientation, race and ethnicity, religion and beliefs, disability, age, and socioeconomic status and background. CLINUVEL’s commitment to, and track record in, treating all employees with equality extends to its interactions with external stakeholders. Diversity in the workforce is a key indicator of an equitable and fair approach to employees. Diversity is continually monitored by the Board.
CLINUVEL takes pride in its leadership on diversity which is represented in gender, age, nationality and use of languages as illustrated overleaf.
Multiple nationalities and linguistic abilities underly CLINUVEL’s diversity beyond gender. The age composition of employees further highlights the diversity of the CLINUVEL team across seasoned and younger personnel at various stages of their career. All are committed to develop their skills and work together in a highly collaborative way to achieve the objectives of the Company, noting the ongoing stewardship of the Company is provided by Generation X and Baby Boomers and the more experienced of the Millennial generation.
| Financial year | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|
| Board (including MD) | 50:50 | 50:50 | 43:57 | 43:57 | 60:40 | 43:57 |
| Top 7 salaries (excluding MD) | 57:43 | 57:43 | 57:43 | 57:43 | 57:43 | 29:71 |
| All employees (including BOD) | 60:40 | 62:38 | 65:35 | 64:36 | 69:31 | 69:31 |
| Financial year | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|
| Up to 2 years | 67 | 56 | 60 | 61 | 59 | 51 |
| +2 and up to 5 years | 14 | 28 | 26 | 24 | 25 | 34 |
| +5 and up to 10 years | 4 | 3 | 3 | 2 | 8 | 8 |
| Over 10 years | 15 | 13 | 11 | 13 | 8 | 7 |
| Financial year | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|
| Total | 15 | 19 | 16 | 22 | 30 | 31 |
| Financial year | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|
| % | 40 | 54 | 51 | 61 | 63 | 68 |
| Financial year | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|
| Generation Z (1997-2012) | 3 | 8 | 10 | 6 | 19 | 14 |
| Generation Y (1981-1996) | 65 | 61 | 59 | 53 | 58 | 64 |
| Generation X (1965-1980) | 22 | 23 | 24 | 35 | 19 | 17 |
| Baby Boomers (1946-1964) | 10 | 8 | 7 | 6 | 4 | 5 |
CLINUVEL recognises the importance of good corporate governance and the role it plays in ensuring business is conducted honestly, fairly, and legally. CLINUVEL is committed to adopting corporate governance policies to achieve the objectives of acting ethically and responsibly, safeguarding integrity in corporate reporting, making timely and balanced disclosures, as well as recognising and managing risks.
The Board of CLINUVEL reviews its policies and governance practices in reference to the eight Principles of Good Corporate Governance (Principles) established by the ASX Corporate Governance Council. The policies and governance practices in place are listed under the Principles below.
The Corporate Governance Protocol and the annual Corporate Governance Statement set out the code of conduct and ethics and other policies to ensure conflicts of interest are avoided and a culture of honesty and integrity is maintained which concords with the expectation of responsible management of ESG issues. To extend this point, CLINUVEL adheres to a policy of adequate and correct communication within the Group, stipulating earnest and direct interaction with its staff and management.
The Anti-Bribery and Corruption Policy prohibits illicit behaviour, and a Whistleblower Policy protects employees who (and who are encouraged to) report behaviours not aligned with the high standard of ethics and honesty embodied in CLINUVEL’s values and culture.
There were no breaches in the Company’s Code of Conduct or Whistleblower reports submitted in FY2025 and up to the date of this Annual Report.
Human Resource policies provide guidance on conflict resolution and communication strategies to be deployed. CLINUVEL adheres to communication guidelines which promote open dialogue with those who seek to interact with CLINUVEL on relevant matters of business, and those who act fairly and openly.
CLINUVEL adheres to Disclosure UK, a searchable database which records annual payments and benefits in kind made by pharmaceutical companies to doctors, nurses, and other health professionals, as part of a Europe-wide initiative to increase transparency in the pharmaceutical-health sector.
Assessment of Key Suppliers Supplier standards have relevance across each ESG area. This is explicit in CLINUVEL’s ESG framework. CLINUVEL accepts the responsibility to understand the ESG practices of its suppliers and to use its relationship with them to influence changes to any behaviours and activities considered necessary to avoid underperformance against minimum ESG standards.
CLINUVEL’s suppliers are considered responsible and active in their practice of ESG. CLINUVEL’s practice has been to assess this on an ongoing basis from regular interactions and reviews of relationships. CLINUVEL has developed a formal process to assess the adherence of our key suppliers to responsible ESG practices. This is focused on key suppliers based on their ranking in CLINUVEL’s annual expenses budget.
CLINUVEL’s Corporate Governance Statement and policies can be found on the Company website https://www.clinuvel.com/about/corporate-governance/.
| Principle | Clinuvel Policy |
|---|---|
| 1. Lay solid foundations for management and oversight |
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| 2. Structure the board to be effective and add value |
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| 3. Instil a culture of acting lawfully, ethically, and responsibly |
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| 4. Safeguard the integrity of corporate reports |
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| 5. Make timely and balanced disclosure |
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| 6. Respect the rights of security holders |
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| 7. Recognise and manage risk |
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| 8. Remunerate fairly and responsibly |
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The Company’s commitment is to continue to evolve and improve ESG practices as an integral part of its focus on continuous improvement and in line with the Company’s growth and expansion.