Revenues
New pharmaceutical development takes considerable time, and commercial success is far from guaranteed as many show us. Despite these challenges, CLINUVEL has proven to be a resilient company with no ongoing debts and the flexibility to strategically use its cash at a time of our choosing. CLINUVEL has continued its advance towards long-term sustainability during FY2025. This is the ninth consecutive year of revenue growth, profit, and net cash inflow – a distinction not mirrored in many biopharmaceutical companies, not in Australia or US. CLINUVEL was recently recognised on Forbes Asia’s (August 2025) list of the best 200 publicly listed companies under a billion dollars revenue in the Asia-Pacific region. Notably, fifteen were Australian and only eight pharma companies made the list.
CLINUVEL has a unique business model among pharmaceutical companies, centered on direct physician engagement. CLINUVEL now works with over 120 medical centers in the U.S.A. in which physicians prescribe SCENESSE® for EPP and conduct our vitiligo trials. We are expanding the distribution of SCENESSE® for erythropoietic protoporphyria (EPP), particularly in Europe, seeking approval for the treatment of adolescents, and to harmonise the frequency of treatment with the approved label in the U.S.A.. We continue to seek new markets on a global scale. CLINUVEL has also supplied SCENESSE® on compassionate grounds. As highlighted in the key achievements of the year on pages 22-23, SCENESSE® was – for the first time in history – successfully administered to a 9-year-old paediatric EPP patient.
There were several key highlights of the financial year. The outstanding presentation of CLINUVEL to attendees at the American Academy of Dermatology (AAD) Meeting in Orlando in March 2025 increased our physician base and is expected to be reflected in patient numbers, new participants in our clinical trials, and sales of SCENESSE®, in time. We intend to repeat this display at the AAD meeting in Denver in U.S.A. in March 2026. Secondly, in May 2025 we reported the completion of recruitment of the first Phase III vitiligo study, CUV105. In parallel, progress has also been made on the development of our PhotoCosmetic products and NEURACTHEL®, an ACTH formulation.
The Board renewed and expanded during the past year. Mrs Brenda Shanahan retired at the Annual General Meeting in October 2024, concluding her distinguished service to CLINUVEL spanning 17 years, including periods as Chair of the Board and Chair of the Audit & Risk Committee. On behalf of the Board, and on a personal level, I thank Mrs Shanahan for her commitment and dedication to CLINUVEL’s journey.
Our three new Non-Executive Directors bring welcome skills to the Board. Mr Matthew Pringle has extensive experience in corporate finance, assurance, governance and strategy and has duly become Chair of the Audit & Risk Committee; Mr Guy van Dievoet has significant experience in international investment banking, specialising in M&A; and Dr Pearl Grimes is a globally recognised dermatologist and leading international authority on vitiligo. Already, the contribution of the new Directors is evident, and the Board has a singular focus to drive growth and achieve further success. The Board is grateful for the support we receive from our Company Secretary, Ms Claire Newstead-Sinclair.
$95.3m
Revenues
$35.6m
Profit
$183.9m
Cash reserves*
18%
ROE
$0.72
EPS
I am continually impressed with the professionalism and commitment of the executive management team and indeed, the commitment of all staff to ensure the pace of activity. The progress of key initiatives continued whilst Dr Wolgen took leave during the year to attend to his health. I specifically thank and congratulate Mr Lachlan Hay for stepping-up to the Acting CEO role to steer the business since March 2025. Dr Wolgen returned to the business full-time in June 2025 to focus on several key initiatives tasked to him by the Board and will return to the CEO role in September 2025. His expertise and experience are highly valued by the Board. As mentioned by Dr Wolgen in his letter in this Annual Report, we also consolidated and enhanced the executive team during the year. Dr Wolgen’s employment agreement runs to 30 June 2026. The Board has commenced the process of CEO succession.
Late in the 2025 financial year, a new Australian analyst commenced coverage of CLINUVEL. Barrenjoey, a well-regarded financial institution with a strategic partnership with Barclays, became the eighth Australian analyst of CLINUVEL. In addition, two German analysts – Parmantier & Cie and Dr Kalliwoda Research – commenced research coverage over the past year, thus extending our reach to existing and new investors in Europe. Ten analysts now cover CLINUVEL. This provides far greater market reach compared to a starting point of one analyst at the beginning of 2019.
All the analysts covering CLINUVEL have issued target prices above our current share price, so they see the opportunities ahead for the Company. Our Investor Relations team continues to work to expand analyst coverage, as a key channel for our compelling investment proposition to reach new investors.
We welcomed new institutional investors during the year. Institutions hold 34% of the issued shares of CLINUVEL compared to less than 20% at the beginning of 2019. Of this, just over half are Australian based and the rest are roughly split between Europe and the U.S.A.. The diversity of geographical ownership has been well maintained. Europe is the largest region of shareholder concentration, followed by Australia and the U.S.A. Analysts and qualified institutions have noticed the diversity and foreign ownership on CLINUVEL’s register.
The American opportunity (refer pages 12-21) is significant for CLINUVEL. Approximately 28% of our issued capital is held by U.S. based investors and interest has been increasing from North American investors who recognise CLINUVEL’s profile as one of the few profitable biopharmaceutical companies. To support this interest and enhance market access to CLINUVEL, the Company announced on 22 August 2025, its intention to upgrade its American Depositary Receipt program from Level I to Level II, listed on Nasdaq, expected to be completed by the end of 2025.
The Board is acutely aware of the decline in the share price over the course of FY2025 and takes the opportunity to expresses its appreciation of the ongoing support of long-term investors and new investors who believe in the path of the Company and the incremental value being built for the future. The stability this provides the Company to focus on its expansion initiatives is crucial.
The disconnect between CLINUVEL’s share price and its financial and operational performance was addressed by Dr Wolgen at last year’s Annual General Meeting. Over the longer-term, however, the progress we make with our strategic objectives – expansion of our markets, acquisition, new product release, completion of clinical trials and their results, and achieving approvals from pharmaceutical regulators – should be reflected in positive movements in the share price. All in all, I have much confidence in our direction and believe we are in far better positioned than when the Company saw a significant spike of its share price on two occasions in the past.
The Board is pleased to have declared an eighth consecutive dividend in respect of FY2025 earnings, unchanged at A$0.05, fully franked for the fourth year, to be paid in September 2025.
The execution of the strategy of the Company has focused during the year on ongoing distribution of SCENESSE® for EPP, product development, and clinical programs. This should return more immediate results to stakeholders. Vitiligo is critical to the Company’s long-term outlook, and in this regard, the five case reports of patients already treated provide insight into the safety and efficacy of SCENESSE® as a systemic repigmentation agent – (see pages 16-18).
The outlook is exciting with commencement of the second vitiligo study, CUV107, planned by the end of Q4 2025 / Q1 2026. Results from the first vitiligo study, CUV105, are expected in the second half of 2026. Launch of melanocortin-based PhotoCosmetic products and the completion of development and regulatory approval of NEURACTHEL® is expected in 2026. Achievement of these milestones will stimulate further market support for CLINUVEL.
I wish all shareholders good health and prosperity for the year ahead.
Professor Jeffrey Rosenfeld
Chair
CLINUVEL Group