SCENESSE® (afamelanotide 16mg)
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Clinuvel Pharmaceuticals (OTCPK:CLVL.Y) Earnings Call Presentation
2025-11-13 23:00
Financial Performance & Growth - CLINUVEL achieved its 9th consecutive annual profit in FY2025[12] - Total revenues, interest, and other income reached A$105.3 million (US$70 million), a 10% increase[13] - Cash reserves increased by 22% to A$224.1 million (US$148 million)[13] - The company reinvests approximately 40% of its profits into RD&I[15] - Net profit margin is 34%[15] Product Pipeline & Market - SCENESSE® is commercially available for adult EPP in multiple regions[8] - CLINUVEL is expanding SCENESSE® to treat adolescent EPP and vitiligo[8] - The total addressable market (TAM) for vitiligo is estimated at US$4.5 billion[10] - The company is pursuing M&A opportunities targeting pharmaceutical and PhotoCosmetic products[11] U.S. Expansion - American revenues now account for over 50% of total revenue[3] - The company is planning a Nasdaq uplisting of its ADRs (Level 2) with an SEC filing expected in Q4[3]
CLINUVEL preparing upgrade of ADR program to Level II, Nasdaq uplist
Globenewswire· 2025-08-22 07:43
Core Viewpoint - CLINUVEL is preparing to upgrade its Level I American Depository Receipts (ADRs) to a Level II program listed on the Nasdaq Stock Market, while maintaining its primary listing on the Australian Securities Exchange (ASX) [2][3][9] Group 1: Upgrade Process - The company has initiated the filing of a Form 20-F registration statement with the U.S. Securities and Exchange Commission (SEC) and is engaging in legal, financial, and regulatory preparations [3][4] - The upgrade is anticipated to be completed before the end of 2025, contingent upon successful SEC review and meeting Nasdaq listing requirements [3][5] Group 2: Strategic Rationale - The move to a Level II ADR and Nasdaq listing aligns with the existing shareholder base, with approximately 28% of issued capital held by U.S.-based investors, and reflects growing interest from North American investors [5][9] - The upgrade is expected to enhance CLINUVEL's visibility and trading access in the U.S. market, particularly as the company develops a significant North American market for vitiligo treatments [5][6] Group 3: Current ADR Program - CLINUVEL's current Level I ADR program represents about 7% of the company's outstanding shares, and there are no plans for capital raising associated with the ADR uplisting [4][9]