Clinuvel Pharmaceuticals (CUV) investor relations material

Strategic direction and business model

• Focus on building a sustainable, integrated biopharmaceutical company with operations in the U.S., Europe, UK, Ireland, and Singapore.

• Emphasis on melanocortin-based products for skin and CNS indications, with a disciplined, scalable approach.

• Expansion in the U.S. market, including direct distribution of SCENESSE® and plans for Nasdaq ADR Level 2 uplisting.

• Zero dilution for 10 years and a debt-free balance sheet for 20 years.

• Active in M&A and in-licensing to broaden product and indication portfolio.

Financial performance and capital management

• Achieved ninth consecutive annual profit in FY2025, with total revenues of A$105.3m (US$70m), up 10%.

• Net profit after tax reached A$36.2m (US$24m), a 2% increase year-over-year.

• Cash reserves grew to A$224.1m (US$148m), up 22%, supporting future R&D and operational needs.

• Maintained a strong net profit margin (~34%) and return on equity (~40%).

• Controlled expenses and disciplined capital deployment underpin financial stability.

Product pipeline and clinical progress

• SCENESSE® commercialized for adult EPP in multiple regions; adolescent EPP and vitiligo programs advancing.

• First phase III vitiligo trial fully recruited; expansion into adolescent and adult vitiligo and variegate porphyria.

• NEURACTHEL® in development for CNS indications, including infantile spasms and multiple sclerosis.

• Five case reports from phase III vitiligo study show significant repigmentation in previously unresponsive patients.

• Path to market for vitiligo includes ongoing phase III studies, U.S. center training, and regulatory submissions.