Image source: Company update

Highlights

  • In FY24, total revenues rose 15% YoY to AUD 95.31 million.
  • CUV declared its seventh consecutive annual dividend, showcasing consistent returns to shareholders.
  • Health Canada validated and accepted the New Drug Submission (NDS) for SCENESSE®, with approval expected in 300 days.

Headquartered in Melbourne, Clinuvel Pharmaceuticals Limited (ASX:CUV) is an international specialty pharmaceutical company. The company is focused on developing and commercialising therapies for patients with genetic, metabolic, systemic, and life-threatening acute conditions. CUV’s flagship product is SCENESSE® (afamelanotide 16mg). Notably, the company has demonstrated eight consecutive years of profitability and continues to deliver consistent dividend payments.

CUV has reported strategic advancements in the financial year 2024. Driven by strong demand for SCENESSE® (afamelanotide), CUV achieved a 15% YoY growth in total revenues, reaching AUD 95.31 million compared to AUD 82.99 million in FY23. In FY24, net profit before tax also rose by 11% YoY, amounting to AUD 50.68 million, while basic earnings per share (EPS) increased by 15% YoY, reaching AUD 0.72.

During the reported period, the company also announced its seventh consecutive annual dividend, reflecting its commitment to shareholder returns.

Recent business update

According to the ASX update dated 23 December 2024, Health Canada has validated and accepted CUV's New Drug Submission (NDS) for SCENESSE®. The approval is expected to increase the company’s presence in Canada. The NDS is now under review by Health Canada’s Health Products and Food Branch (HPFB). The review is expected to take 300 days.

Strategic Outlook and Opportunities

Following the validation of its NDS for SCENESSE® by Health Canada, CUV anticipates approval to provide treatment for approximately 280 EPP patients. The company is refocusing its efforts on programs with strong commercial potential. The PhotoCosmetics program is expected to diversify CUV’s revenue streams and enhance its presence in the consumer skincare market.

CUV is advancing key projects such as expanding the U.S. Specialty Center network, conducting clinical studies targeting variegate porphyria and adolescent EPP, and awaiting European Medicines Agency (EMA) decisions on label extensions for SCENESSE®.

Share performance of CUV

CUV shares closed 0.25% lower at AUD 11.77 per share on 8 December 2024. In the past year, CUV’s share price has dropped by almost 27.08%, and in the past three months, it has decreased by nearly 15.69%.

52-week high of CUV is AUD 17.71, recorded on 5 July 2024 and 52-week low is AUD 11.65, recorded on 8 January 2025.

Note 1: Past performance is neither an Indicator nor a guarantee of future performance.

Note 2: The reference date for all price data, and currency, is 08 January 2025. The reference data in this report has been partly sourced from REFINITIV.