Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Investor Presentation (October 2022)
11 slides from Clinuvel Pharmaceuticals's investor presentation, Oct 21, 2022
Slide 1: Investor Briefing Melbourne
For personal use only CLINUVEL PHARMACEUTICALS Investor Briefing Melbourne 20 October 2022 Philippe Wolgen – Chief Executive Officer ASX: CUV XETRA-DAX: UR9 Level 1 ADR: CLVLY clinuvel.com news.clinuvel.com
Slide 2: Forward-Looking Statement
Forward-Looking Statement 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 or achievements t
Slide 3: Pipeline - melanocortins
Pipeline - melanocortins For personal use only Principal program Preclinical Phase I Phase II Phase III Commercial SCENESSE® (afamelanotide 16mg) in adult EPP patients (EEA, UK, CH, USA, ISL, AUS) SCENESSE® (afamelanotide 16mg) in adolescent EPP patients SCENESSE® (afamelanotide 16mg) in XP patients
Slide 4: Arterial Ischaemic Stroke
Arterial Ischaemic Stroke For personal use only Targeted product position A hormonal treatment to assist hypoxic brain. Study CUV801 (n=6): Proof of Concept - afamelanotide • open-label, up to 4 doses: days 0, 1, 7, 8; evaluation at day 42 • occlusion higher regions: > M2/A2/P2 • functional recovery
Slide 5: Xeroderma Pigmentosum (XP) Clinical Program – DNA Repair
Xeroderma Pigmentosum (XP) For personal use only Clinical Program – DNA Repair CUV156 CUV151 XP-C n=6 Disease-free subjects n=10 CUV152 CUV153 XP-V, XP-C n=6 XP-V, XP-C n=6 CUV154 XP-V, XP-C n=20 Clinical Profile • Gene defects: 3p25, 6p21 • Highest rate of skin cancer(s) – shortened life expectancy
Slide 6: Vitiligo Clinical Program
Vitiligo For personal use only Clinical Program CUV102 +NB-UVB n=56 2022: >12,700 doses FDA accepts CUV103 safety profile afamelanotide +NB-UVB n=21 A B CUV104 FDA sets precedent for NB-UVB CUV105 Nov ’22 monotherapy n=6 +NB-UVB n=85 as combination therapy First topical treatment approved CUV106 CUV
Slide 7: Healthcare Solutions
Healthcare Solutions For personal use only 1. Targeted Technology Translation 2. Melanocortins Add to Pharmaceuticals, Healthcare Solutions Use in non-prescription products 3. Populations at Highest Risk of photodamage - UV/HEV (λ) 3 populations unaddressed with high need 4. Dermatocosmetic Product
Slide 8: EPP Commercial Market
EPP Commercial Market For personal use only Uniform pricing policy per jurisdiction • Equitability, transparency • No rebates, no discounts 45.5% revenue CAGR 6 years to 30 June 2022 Integrated model • Direct distribution network • Market access • Price negotiations
Slide 9: Financials 2005 – 2022
Financials 2005 – 2022 For personal use only FY’22 dividend: 10% of net profit <300% dilution ROCE 27% (6yrs) Cash reserves: AUS $121m (30 June ‘22) Expenses: AUS $55.5m (FY ‘21-22) AUS $175m (FY ‘21-25) Nasdaq ’22* Bio-pharmaceuticals Profitable Main board 798 67 (8.4%) NBI 274 25 (9.1%) ASX 91 3 (
Slide 10: Summary: Catalysts 2022-2023
Summary For personal use only CATALYSTS 2022-2023 Pharmaceuticals XP/DNA repair read out Ph II 1 Stroke – reduction in penumbra, NIHSS (1 trial) 2 Xeroderma pigmentosum – assisted DNA repair (3 trials ongoing) Start Ph II trial vitiligo Vitiligo - afamelanotide monotherapy + combination Start Ph II
Slide 11: For personal use only
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 www.clinuvel.com Level 11, 535 Bourke Street Melbourne
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