Chair’s Letter

Dear Shareholders

Focus on the Mission

I was pleased to assume the role of Chair of the CLINUVEL Group mid-way through the 2024 financial year, a year marked by our ongoing focus to advance a range of initiatives to build a house of melanocortin based treatments for long-term sustainability. Our expertise in targeted receptor melanocortins is being applied to conditions of the skin and brain which have unmet medical needs. We are also translating this technology into PhotoCosmetic products for people in the general population to benefit from photoprotection, DNA repair and re-pigmentation (bronzing).

Achievements FY2024

Let’s review the year and the advances made across the range of initiatives:

The distribution of SCENESSE® for EPP continued to grow in terms of number of patients, prescribing doctors, and centres administering treatment.
We commenced a partnership with Valentech, enabling important access to treat EPP patients in Latin America, but ceased our partnership in China, until greater certainty over IP protection prevails.
We expanded the CUV052 study to n=28, covering adolescent and adult patients >50 kg in weight to support the submission for the label expansion of SCENESSE® for adolescent EPP patients.
In the US, we extended reimbursement of the cost of treatment to US veterans and their families and continued the expansion of Specialty Centers from over 50 to 85, as we head towards 120 centers by the end of 2025. This network is being put in place to treat both EPP and vitiligo patients, ahead of the completion of clinical studies on vitiligo.
In vitiligo, we formed an expert medical panel, commenced the recruitment of patients for the Phase III study CUV105 in October 2023, and in March 2024 saw positive results experienced by a new patient presented at the American Academy of Dermatology.
In DNA Repair, we provided readouts for CUV151 showing afamelanotide reduced DNA damage in a healthy population and continued the studies on XP.
The CUV803 study looking to address arterial ischaemic stroke is also ongoing.
We announced Parkinson’s disease in June as a new indication with a Phase IIa study, CUV901 commencing later this calendar year, involving 6 patients receiving 11 doses of afamelanotide over a study period of 56 days.
In June we initiated a soft launch of CYACÊLLE Radiant, a new polychromatic product providing photoprotection that paves the way for the melanocortin product range under development for the preservation and bronzing of the skin.

Our strong financial performance continued with increased revenues, profit, and net cash inflow achieved for the eighth consecutive financial year. We are pleased with the 15% growth in revenues and ongoing prudent management of expenses achieved in FY2024. Cash reserves* accumulated further this year from $156.8 million to $183.9 million and enable us to finance organic expansion, the share buy-back program, and the flexibility to manage external events and circumstances.

The Board was proud to declare a seventh consecutive annual dividend to shareholders, which will be paid to shareholders in September.

*Cash reserves as stated in a non-IFRS measure

$95.3m

Revenues

$35.6m

Profit

$183.9m

Cash reserves*

18%

ROE

$0.72

EPS

People

We have thoughtfully increased staff numbers in recent years to support the expansion of the Group. We are fortunate to have attracted well-credentialed professionals in a highly competitive international labour market to advance CLINUVEL’s objectives over the past years.

The Executive management team has changed and expanded in FY2024. We were pleased to re-engage Dr Emilie Rodenburger in the position of Director, Global Clinical Affairs in April. As of 1 July 2024, Mr Peter Vaughan took over as Chief Financial Officer (CFO) from Mr Darren Keamy, CLINUVEL’s leading finance executive for 19 years. We thank Darren very much for his dedicated service to the Company and wish him well as he takes a well-earned sabbatical. In August 2024, we appointed Ms Claire Newstead-Sinclair as Company Secretary (CS). Previously this role was undertaken by Mr Keamy, but the Board decided that the CFO and CS roles should be separate, particularly as the complexity and breadth of the business has increased. Reflecting this, the CS role will assume responsibility for the risk management of environmental, social and governance risks as part of the Company’s drive to responsible sustainability. We welcome Dr Rodenburger and Mr Vaughan to the Executive management team to help collectively advance our strategic initiatives.

I am also pleased that we secured a one-year extension to the services of Dr Wolgen as Managing Director (MD) and Chief Executive Officer (CEO) to 30 June 2026, providing the assurance of the continuity and advancement of our wide-ranging initiatives under his leadership. This now enables the Board to follow a process of putting longer-term succession in place.

Board

We acknowledge the service of Mr Willem Blijdorp, who served just over four years as Chair.

As the new Chair, I instigated a full Governance Review and Board Strategy Review guided by experienced external consultants. These have been completed and have been valuable in the Board’s operations.

Since my appointment as Chair on 1 January, I have been actively overseeing the recruitment of new Non-Executive Directors to the Board.

We aim to formalise the recruitment of two to three Non-Executive Directors to the Board in the coming months, following an international search.

There have been no adverse issues from a governance perspective over the past year, further extending CLINUVEL’s record of operating at the highest ethical and professional standard. I am sincerely grateful to my fellow Board members for their support and effort over the past year and thank all CLINUVELLIANS for their steadfast focus on the objectives of the Company.

Shareholders

We actively engage shareholders on their views of the Company and take them into account in our decisions and communications. Let me provide you a few examples:

Last October, ex-Chair Willem Blijdorp together with investor relations spoke to shareholders in Australia, New Zealand, Europe and the USA and their feedback is reflected in the extension of the CEO’s contract to June 2026, mentioned above.
The Capital Markets Briefing in May in Sydney was a good opportunity for me as a newly elected Chair to talk to institutional investors and I was pleased with their understanding of the depth and promise of the pipeline.
I have also received correspondence from many shareholders and exchanged views on the Company and its progress.

Despite the strong financial performance of the Company, the commercial progress of SCENESSE® and the potential of the pipeline, CLINUVEL’s market value was lower in the past year. This is below what we regard as fair value, and given the sufficiency of cash reserves, we implemented a share buy-back program in March to provide some support to the share price. Many shareholders expressed their appreciation of this initiative.

It is important that the Company’s course remains steady and focused on our objectives. At this year’s Annual General Meeting, I am looking for shareholders to support the uninterrupted direction of the Company to execute our diversification initiatives. The risk of disruption will not be in the interests of shareholders.

Outlook

Looking to the future, we are actively executing our vision of a strategic house of melanocortins, maintaining focus on the commercial efforts in EPP, and investing to drive pipeline initiatives. These encompass the drug products, PRÉNUMBRA® and NEURACTHEL®, clinical programs in vitiligo, variegate porphyria, DNA Repair, stroke and Parkinson’s, and the development of a range of PhotoCosmetic products.

CLINUVEL is on the path to transform its operating and financial profile through expanded product offerings for unmet needs. All stakeholders can see the incremental value being built. For example, the first few years of treatment of vitiligo has the potential to generate significant revenues. This is also the case for the distribution of NEURACTHEL® and shareholders have also recognised the potential of our PhotoCosmetic product range. For investors, the rationale for their investment in CLINUVEL is compelling as we strive to advance the strategic priorities to fruition over the coming years.

I wish all stakeholders good health and look forward with you to the advancement of our objectives in the 2025 financial year and beyond.

Professor Jeffrey Rosenfeld
Chair
CLINUVEL Group

Corporate governance

CLINUVEL Pharmaceuticals Ltd and its Board are committed to establishing and achieving the highest standards of corporate governance. The Company’s Corporate Governance Statement for the year ending 30 June 2024, based on the Australian Securities Exchange Corporate Governance Council’s (ASXCGC) Corporate Governance Principles and Recommendations, 4th Edition, can be found on our website at https://www.clinuvel.com/clinuvel/company-overview/corporate-governance.