Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Jefferies London Healthcare Conference 2022
13 slides from Clinuvel Pharmaceuticals's conference presentation, Nov 17, 2022
Slide 1: Growth of a Specialty Pharmaceutical
Growth of a Specialty Pharmaceutical CLINUVEL Jefferies London Healthcare Conference November 15th -17th, 2022 Philippe Wolgen CEO ASX: CUV XETRA-DAX: UR9 Level 1 ADR: CLVLY clinuvel.com news.clinuvel.com
Slide 2: Forward-Looking Statement
Forward-Looking Statement 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 to differ significantly
Slide 3: Business Evolution — specialized in melanocortins
== Business Evolution — specialized in melanocortins a Date Cumulative spend _ Key activities 1980-2005 aus$70m Invention aimed at lifestyle j 2006-2016 aus$150m Restructure | Reformulation | Regulatory ‘ 2017-2022 aus$320m Commercialisation | Profitability | Liqu 2023-2024 aus$495m Expansion | Scal
Slide 4: EPP Commercial Market
EPP Commercial Market Uniform pricing policy per jurisdiction • Equitability, transparency to insurers Safety – pharmacovigilance • No rebates, no discounts • > 12,000 injections • Disintermediation • 1,300 patients • Controlled distribution > 90 hospitals/clinics 45.5% CAGR revenue (6y 30 Jun 2022)
Slide 5: Financials 2005 – 2022
Financials 2005 – 2022 FY’22 dividend 10% of net profit <300% dilution 17 y ROCE 27% (6y) Cash reserves AUS $137.6m (30 Sept ‘22) Expenses AUS $55.5m (FY ‘21-22) AUS $175m (FY ‘21-25) Exchange Bio-pharmaceuticals Profitability Nasdaq, Main Board 798 67 (8.4%) Nasdaq, NBI 274 25 (9.1%) ASX 91 3 (3.2%
Slide 6: Price Earnings Ratio 2016 – 2022
Price Earnings Ratio 2016 – 2022 100 80 CLINUVEL’s PE Ratio 60 • Positive since 30 June 2017 40 • Trend driven by share price 20 • Higher than key markets 0 ▪ ASX: ▪ long-term trend 15.0 -20 ▪ 23.4 (4 Nov ‘22) -40 ▪ US Biotech Industry (median): -60 • 5 year avg 18.7 -80 • 14.2 (7 Nov ’22) -100 -120
Slide 7: Pipeline - melanocortins
Pipeline - melanocortins 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 / DNA repair SCENESSE
Slide 8: Arterial Ischaemic Stroke
Arterial Ischaemic Stroke 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 in 5 patients; NIHSS
Slide 9: Xeroderma Pigmentosum (XP)
Xeroderma Pigmentosum (XP) 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) – short life expectancy Addressable Market • 1,00
Slide 10: Vitiligo
Vitiligo 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 set precedent for NB-UVB CUV105 Nov ’22 monotherapy n=6 +NB-UVB n=85 as combination therapy First topical treatment approved CUV106 CUV107 14 months monothera
Slide 11: Healthcare Solutions
Healthcare Solutions 1. Targeted Technology Translation 2. Melanocortins Pharmaceuticals to Healthcare Solutions Use in non-prescription products 3. Populations at Highest Risk of Exposure to UV/HEV λ 3 unaddressed categories 4. Dermatocosmetic Product Portfolio 5. Targeted Digital Marketing Social
Slide 12: Summary
Summary Pharmaceuticals Catalysts 2022-23 I. SCENESSE® Commercial distribution in EPP: US-EU-CH-IL Expansion to adolescents II. PRÉNUMBRA® First use in Stroke trial III. NEURACTHEL® in manufacturing: 2023 1 Stroke – reduction in penumbra, NIHSS 1 trial 2 Xeroderma pigmentosum – assisted DNA repair 3
Slide 13: Authorised for ASX release by the Board of Directors
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, Victoria, Australia,
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