Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Stifel Healthcare Conference 2025
16 slides from Clinuvel Pharmaceuticals's conference presentation, Nov 14, 2025
Slide 1: A distinct business model: Success through discipline
For personal use only A distinct business model Success through discipline Stifel Healthcare Conference : 11–13 November 2025 Philippe Wolgen | CEO ASX: CUV | Börse Frankfurt: UR9 | ADR Level 1: CLVLY (uplist to Level 2 in progress)
Slide 2: Forward-Looking Statement
FORWARD-LOOKING STATEMENT For personal use only CLINUVEL GROUP This release contains forward-looking statements, which reflect the current beliefs and U.S., Europe, the UK, Israel, China, Japan, and/or LATAM regions of our agreements with expectations of CLINUVEL’s management. All statements other t
Slide 3: Expanding a U.S.A. presence
Expanding a U.S.A. For personal use only presence Increased American investor interest • Phase III vitiligo – 1st systemic Rx [not immune suppressive] • SCENESSE® in EPP - direct distribution >100 US centers • American revenues >50% • Nasdaq uplisting ADRs (Level 2) – SEC filing Q4 • American manage
Slide 4: Building a sustainable, integrated biopharmaceutical company
Building a sustainable, integrated biopharmaceutical company For personal use only Focused, scalable, disciplined, melanocortins, chemistry, pharmacology use of melanocortins HQ – Melbourne formulation development Principle operations – U.S.A, Europe, UK, Ireland, Singapore manufacturing In-licensin
Slide 5: Pipeline focus: melanocortins (Skin, CNS)
Pipeline focus: melanocortins (Skin, CNS) For personal use only Preclinical Phase I Phase II Phase III Commercial SCENESSE® (afamelanotide 16 mg) in adult EPP (EEA, UK, CH, USA, ISL, CAN, AUS) SCENESSE® (afamelanotide 16 mg) in adolescent EPP SKIN SCENESSE® (afamelanotide 16 mg) in adolescent and ad
Slide 6: Vision of the Future
Vision of the Future For personal use only Foundation of 20 years MELANOCORTIN HOUSE Products, indications & healthcare solutions • 2 pharmaceutical products • 5 conditions • 3 PhotoCosmetic product lines TAM >$300m Advancing RD&I PORPHYRIA • novel sustained-release liquid formulation CUV: FY25 $69m
Slide 7: FY2025 Financial excellence – a distinct model
FY2025 Financial excellence – a distinct model For personal use only • disciplined and balanced approach C O N S O L I D AT E D E N T I T Y 30 June 2025 Change • 9th consecutive annual profit Total Revenues, Interest and Other Income A$m 105.3 [US$70m] + 10% • controlled expenses Total Expenses A$m
Slide 8: SCENESSE in EPP – profitability
FY2025 30 June (A$m) Profitability 120 55 For personal use only 90 45 SCENESSE® in EPP – profitability 60 35 9 years of growth in revenues CAGR 35% 30 controlled increase of expenses CAGR 20% 25 net profit margin 34% 0 reinvestment RD&I ~40% 15 -30 return on equity 16% -60 5 2017 2018 2019 2020 2021
Slide 9: Strongest balance sheet
Assets & liabilities (A$m) FY2025 280 240 Strongest balance sheet [‘05–’25] 200 For personal use only 160 120 On 30 June, in Australian dollars 2024 2025 r 80 A$231.1m A$271.8m 40 Total assets +18% [US$152.5m] [US$179m] 0 Assets Liabilities FY2021 FY2022 FY2023 FY2024 FY2025 Total liabilities A$28.1
Slide 10: EPP, VP and Vitiligo addressable markets
>U$300m U$4.5b Total addressable market (US$) Total addressable market (US$) Large unmet EPP VP Vitiligo For personal use only Erythropoietic Variegate clinical need Protoporphyria Porphyria Genetic disorder: absolute light Genetic disorder: blister, Gradual loss of skin intolerance, phototoxicity p
Slide 11: CUV102 Phase II study results
Day 0 Baseline CUV102 Phase II study results • Scientific basis for phase III For personal use only Day 35 – 15 treatments/1 implant Day 66 – 29 treatments/2 implants Day 171 – 62 treatments/4 implants Day 0 Day 111 Day 179 Baseline 27 treatments/3 implants 40 treatments/4 implants
Slide 12: Follicular repigmentation mechanism
Hair follicle NB-UVB – follicular Epidermis repigmentation For personal use only • NB-UVB differentiating follicular stem cells • Melanoblasts migrating, become fully functioning melanocytes • Afamelanotide acting as agonist to MC1R expressed NB-UVB [308-313nm] Dermal sheath Bulge/Niche Dermis Day 0
Slide 13: CUV105 First Phase III study case report
CUV105 First Phase III study For personal use only CASE REPORT 1 Female, 55 years old, Skin Type IV Diagnosed with vitiligo in 2006, slowly progressive disease activity, no previous episodes of repigmentation, no family history of vitiligo. Unresponsive to previous vitiligo treatments. Physician’s r
Slide 14: CUV105 First Phase III study case report
CUV105 First Phase III study For personal use only CASE REPORT 2 Male, 56 years old, Skin Type IV Diagnosed with vitiligo in 1999 Physician’s report First repigmentation seen around day 42, considerable repigmentation seen by day 106. Patient continued to repigment after conclusion of treatment prot
Slide 15: Vitiligo – path to market
EMA/FDA CUV102 CUV103 CUV104 CUV105 CUV107 submission1 For personal use only +NB-UVB, +NB-UVB, monotherapy, +NB-UVB, +NB-UVB, n = 56 n = 56 n=6 n = 210 n = ~200 (2012) (2016) (2023) (2024; fully enrolled (Q1 2026 first patient) May 2025) Vitiligo – path to market CATALYSTS 2024/2025: 2025: Train/acc
Slide 16: Thank You
For personal use only Thank You Authorised for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTD Head of Investor Relations: Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD Investor Enquiries: https://www.clinuvel.com/investors/contact-us Level 22, 535 Bourke Street, Melbourne – Vi
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