CLINUVEL Pharmaceuticals (ASX:CUV) has reported its strongest December half-year revenue on record, underscoring what it describes as the resilience of its commercial platform and the disciplined execution of its long-term growth strategy.
CLINUVEL’s lead therapy, SCENESSE (afamelanotide 16mg), remains the world’s first approved systemic photoprotective treatment for adult patients with erythropoietic protoporphyria, with commercial distribution across Europe, the United States, Israel, and Australia.
In the six months to 31 December 2025, the Melbourne-headquartered company generated $36.9 million in sales revenue, a 4 per cent increase on the prior corresponding period, while total revenue reached $40.6 million.
The result marks the company’s twentieth consecutive half-year profit. Net profit after tax came in at $10.4 million, down 26 per cent year-on-year, reflecting a deliberate increase in operating expenditure tied to strategic expansion initiatives. Basic earnings per share followed the same trajectory, declining to $0.21 from $0.28 in the prior period.
Operating expenses rose 22 per cent overall, driven primarily by a 16 per cent increase in personnel costs and a 19 per cent lift in clinical and non-clinical development expenditure. Commercial distribution expenses climbed 42 per cent, while finance and legal costs increased 47 per cent, largely associated with the company’s application to the U.S. Securities and Exchange Commission to upgrade its Level I American Depositary Receipts to Level II with a listing on NASDAQ. Despite the higher cost base, CLINUVEL strengthened its balance sheet, lifting cash and term deposits to $233 million and increasing net assets by 4 per cent to $249 million. The company remains free of external borrowings.
Chief Financial Officer Peter Vaughan said the results demonstrated the strength of CLINUVEL’s conservative and non-dilutive operating model. With positive cash flows, zero debt, and a decade without equity dilution, he noted that the company continues to build long-term shareholder value through consistent performance and capital discipline.
Chief Executive Officer Dr Philippe Wolgen emphasised that the increase in expenditure aligns with expansion plans first outlined in prior financial years. Since the commencement of commercial operations in June 2016, CLINUVEL has operated an integrated business model designed to sustain profitability while funding organic growth. The company’s core market in erythropoietic protoporphyria continues to expand steadily, while preparations are underway to address larger markets in vitiligo and to support the first market entry for NEURACTHEL, an ACTH analogue in development.