Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Non-Deal Roadshow (June 2026)
21 slides from Clinuvel Pharmaceuticals's roadshow presentation, Jun 2, 2026
Slide 1: Pioneering treatments for patients with significant unmet needs
For personal use only Pioneering treatments for patients with significant unmet needs Non-Confidential Presentation June 2026 ASX: CUV | Börse Frankfurt: UR9 | ADR Level I: CLVLY (uplist to Level II in progress)
Slide 2: Safe harbor statement
Safe harbor 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 than
Slide 3: Building a sustainable, integrated biopharmaceutical company
Building a sustainable, integrated Profitable, focused, disciplined biopharmaceutical company Nine and a half years profitable (to 31 Dec 2025) HQ – Australia For personal use only Growing revenue base Principal operations – U.S.A, Europe, UK, Ireland, Singapore Strong balance sheet • zero debt • ca
Slide 4: A distinct business model
A distinct business model For personal use only Melanocortins Peptides / Hormones Long-term safety Controlled-release Formulation Development In-house development EXPERTISE Porphyria, vitiligo FISCAL DISCIPLINE Clinical Expertise Central nervous system CLINICAL FOCUS Direct distribution >15 countrie
Slide 5: Commercial product and pipeline: melanocortins
Commercial product and pipeline: melanocortins For personal use only Preclinical Phase I Phase II Phase III Commercial SCENESSE® (afamelanotide 16 mg) in adult EPP Europe, CH, USA, ISL, CAN 1 SCENESSE® (afamelanotide 16 mg) in adolescent EPP Filing in H2 2026 SCENESSE® (afamelanotide 16 mg) in adole
Slide 6: FY2025 Financial performance
FY2025 Financial performance For personal use only • disciplined and balanced approach CONSOLIDATED ENTITY 30 June 2025 Change • 9 consecutive annual profits ▪ continued in six months to 31 December 2025 Revenues US$61m + 6% • controlled expenses Total Operating Expenses US$23m + 24% • RD&I growth N
Slide 7: Profitability
30 June 2025 (A$m) FY2025 120 55 Profitability 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 0 net profit margin 34% 15 reinvestment RD&I ~40% -30 return on equity 16% -60 5 2017 2018 2019 2020
Slide 8: Expanding presence: U.S.A.
Expanding presence: U.S.A. For personal use only Increased American investor interest • Phase III vitiligo – 1st systemic Rx [not immune suppressive] • SCENESSE® in EPP - direct distribution >120 US centers • US comprises >50% of revenue • Nasdaq uplisting ADRs (Level II) – SEC filing pending 8
Slide 9: Future outlook
Future outlook Foundation of 20 years For personal use only Products, indications & healthcare solutions • 2 pharmaceutical products MELANOCORTIN HOUSE • 5 conditions • 3 PhotoCosmetic product lines TAM >US$300m Advancing RD&I Porphyria (EPP & VP) • novel sustained-release liquid peptide TAM US$4.5b
Slide 10: Large unmet clinical need
Large unmet >US$300m US$4.5b Total addressable market Total addressable market clinical need For personal use only Erythropoietic Variegate EPP Protoporphyria VP Porphyria Vitiligo Genetic disorder: absolute light Genetic disorder: blister, Gradual loss of skin Clinical problems solved: intolerance,
Slide 11: SCENESSE first approved treatment for EPP
SCENESSE ® first approved treatment for EPP For personal use only MARKETS ACCESSED IT CH EU USA ISR SCO CAN 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 EU – DEC 14 USA – OCT 19 AUS – OCT 20 EU – INCREASED DOSAGE REGULATORY APPROVAL DISTRIBUTION EU U.S.A. Rigorous
Slide 12: Vitiligo market: significant opportunity
1% Prevalence Total addressable market Vitiligo market: U.S.A. 3,295,000 US$4.5b significant opportunity For personal use only Commercial preparation establish systems, NB-UVB 25% Eligible Distribution 823,750 1 national team (20) 40% (0.5% BSA, 0.2% H/N) 329,500 20% Seeking treatment Prescribers 65
Slide 13: NB-UVB 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 acts as agonist to MC1R expressed NB-UVB [308-313nm] Dermal sheath Bulge/Niche Dermis Day 0
Slide 14: CUV102 vitiligo study
Day 0 Baseline CUV102 vitiligo study 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 14
Slide 15: CUV105 vitiligo phase III study – case reports published
CUV105 vitiligo phase III study – 12 case reports published 1 CASE REPORT 1 CASE REPORT 9 • Female, 55 years old, Skin Type IV • Male, 42 years old, Skin Type V • Diagnosed with vitiligo in 2006, slowly progressive disease activity, no • Diagnosed with vitiligo in 2015, patient previously seen spont
Slide 16: Regulatory strategy vitiligo
Regulatory strategy vitiligo For personal use only Proof of concept 2026 EMA/FDA IRB/Ethics/DMSB CUV101–102–103 SCENESSE® adjunct NB-UVB EMA scientific advice (April 2026) - Emphasised “totality of evidence’’ approach CUV104 SCENESSE® - Central photographic review and validated disease assessment mo
Slide 17: NEURACTHEL
For personal use only NEURACTHEL ® • ACTH generic product manufacturing validation completed • Three validated batches, stability supports product dossiers • NEURACTHEL® Instant validated with European partner • Stock is available for clinical use, pending regulatory approval • European regulatory f
Slide 18: Calendar & catalysts
Calendar & catalysts For personal use only 2026 H1 H2 2027 H1 H2 Health Canada: SCENESSE® Marketing Authorization decision EMA filing SCENESSE®: adolescent use in EPP Phase III, CUV105 vitiligo AAD’26 cases presented √ Top line results Complete results Phase III, CUV107 vitiligo EMA Scientific Advic
Slide 19: Targeted technology translation
Targeted technology For personal use only translation PROTECT-PRESERVE-BRONZE Translating our technology & knowhow to develop a range of PhotoCosmetic products to assist people in need of photoprotection, DNA repair and melanogenesis Total Addressable Market US$6.2b 19
Slide 20: Strong balance sheet
Assets & liabilities (A$m) 280 FY2025 240 Strong balance sheet 200 For personal use only 160 June 30, in US$ 2024 2025 120 80 Total assets US$154m US$177m +15% 40 0 Total liabilities Assets Liabilities • trade creditors US$19m US$20m +7% FY2021 FY2022 FY2023 FY2024 FY2025 • debt-free (20th year) C
Slide 21: 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 – V
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