Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — BTIG Biotechnology Conference 2025
19 slides from Clinuvel Pharmaceuticals's conference presentation, Jul 30, 2025
Slide 1: BTIG Biotechnology Conference, New York
For personal use only BTIG Biotechnology Conference, New York Lachlan Hay, COO, Acting CEO 30 July 2025 ASX: CUV | Börse Frankfurt: UR9 | ADR Level 1: CLVLY
Slide 2: Forward-looking statement
Forward-looking statement CLINUVEL GROUP For personal use only This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. Statements may involve a number of known and unknown risks that could cause our future results, performance, o
Slide 3: Commercial stage biopharmaceutical and pipeline
ASX: CUV | Börse Frankfurt: UR9 | ADR Level 1: CLVLY For personal use only Commercial stage Pipeline – melanocortin peptides biopharmaceutical Early Ph II Ph III Approved • Commercialized NCE1 SCENESSE® (afamelanotide) for SCENESSE® in adult EPP rare metabolic disorder SCENESSE® in adolescent EPP •
Slide 4: Profitability
Profitability Revenue growth, profitability from distribution of SCENESSE® in EPP For personal use only • 8 years consecutive annual June Year, A$m revenues growth (CAGR 38%) 100 60 80 • Controlled fixed costs support expansion 50 (expenses CAGR 20%) 60 40 40 • 8-year average EBIT Margin 48%, Profit
Slide 5: Balance Sheet Strength
Balance Sheet Strength Enables self-financing expansion FY25 results (year to 30 Jun ‘25) to be For personal use only reported by the end of August 2025 TOTAL ASSETS, CASH RESERVES AND NET ASSETS ($m) $m 31 Dec ’24 30 Jun ’24 250 Total Assets 236.2m (+2.2%) 231.1m Cash Reserves 198.2m (+7.8%) 183.9m
Slide 6: Focused Expansion strategy
Focused Expansion strategy For personal use only Integration of key functions ‘in-house’ Melanocortin product Translation of technology Distribution SCENESSE® development, clinical studies to PhotoCosmetic products M&A Focus on increasing patients, PRÉNUMBRA® 1. Polychromatic screen Vertical integra
Slide 7: SCENESSE in erythropoietic protoporphyria (EPP)
SCENESSE* in eryLhropoielic proloporphyria (EPP)
Slide 8: Adult erythropoietic protoporphyria (EPP) patient
For personal use only “ Adult erythropoietic protoporphyria (EPP) patient
Slide 9: SCENESSE in erythropoietic protoporphyria (EPP)
SCENESSE® in erythropoietic protoporphyria (EPP) CLINUVEL’s novel drug for rare disease For personal use only SCENESSE® (afamelanotide) • subcutaneous, injectable, controlled release implant • 60-day dosing, activates melanin, strong anti-oxidant • world’s first systemic photoprotective EPP • geneti
Slide 10: For personal use only
For personal use only ®
Slide 11: NB-UVB – follicular repigmentation
NB-UVB – follicular repigmentation NB-UVB differentiating For personal use only Hair follicle follicular stem cells Epidermis Melanoblasts migrating, become fully functioning melanocytes Afamelanotide acting as agonist to MC1R expressed Dermal NB-UVB [308-313nm] sheath Bulge/Niche Dermis Day 0 Basel
Slide 12: CUV102 Phase II study results
CUV102 Phase II study results Day 0 – Baseline 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 Images have been amended/cropped and pixelated t
Slide 13: CUV105 Phase III study – first clinical observations
CUV105 Phase III study – first clinical observations CASE REPORT 1 CASE REPORT 3 Female, 55 years old, Skin Type IV PHYSICIAN’S REPORT Male, 56 years old, Skin Type IV PHYSICIAN’S REPORT For personal use only Diagnosed with vitiligo in 2006, slowly 0–90% repigmentation seen after Diagnosed with viti
Slide 14: CUV105 Phase III study – first clinical observations
CUV105 Phase III study – first clinical observations CASE REPORT 5 • Male, 46 years old, Skin Type V, diagnosed with vitiligo in 2004 • Images demonstrate repigmentation of vitiliginous lesions on right forearm (top) and lower legs (bottom). The red outlines demonstrates the extent of the initially
Slide 15: Vitiligo Addressable Market USA
Vitiligo Addressable Market USA – afamelanotide for FST IV-V-VI For personal use only INCIDENCE FST IV-V-VI ELIGIBLE FOR Tx SEEKING Tx PENETRATION 7–8 doses pp for >90% repigmentation No. 3,295,000 823,750 329,500 65,900 5,931 Revenues, yr 1–2 US$490–570m 40% 9% yr 1–2 0.5% BSA 20% 0.2% H&N 25% 1% o
Slide 16: US Commercial Infrastructure
US Commercial Infrastructure Direct Distribution 2019–2025 For personal use only In-house commercial team Logistics Medical centers Director, Nth American Operations DC – cold storage orders Financial specialists labelling / packaging pharmacy storage VA-Medicare-Medicaid QA Rx filled Patient liaiso
Slide 17: Catalysts and calendar 2025-2026
Catalysts and calendar 2025-2026 For personal use only Commercial growth SCENESSE® Financial year end results FY25 4th week August EMA decision dosage expansion adults Q4 2025 EMA re-file adolescents SCENESSE® Q4 2025 Health Canada decision marketing authorisation: SCENESSE® in EPP Q4 2025 Distribut
Slide 18: Vision of the Future
Vision of the Future A house of melanocortins For personal use only A pharmaceutical group, diversified and integrated to sustain long-term performance Products, indications & healthcare solutions • 3 pharmaceutical products • 5 conditions treated TAM >$300m • 3 PhotoCosmetic product lines PORPHYRIA
Slide 19: Investor contact details
For personal use only 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 – Victoria, Au
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