Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Goldman Sachs Emerging Leaders Conference 2019
15 slides from Clinuvel Pharmaceuticals's conference presentation, Apr 4, 2019
Slide 1: Pioneering a Novel Medical Concept
PIONEERING A NOVEL MEDICAL CONCEPT CLINUVEL: from concept to commercialisation 04 April 2019 CLINUVEL PHARMACEUTICALS LTD ASX: CUV Darren Keamy, CFO Nasdaq Int’l: CLVLY Xetra-Dax: UR9
Slide 2: Safe harbour statement
Safe harbour 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 fr
Slide 3: CLINUVEL
CLINUVEL • Pioneers of new medical concept – medicinal photoprotection • Approved orphan product (NME) in Europe – SCENESSE® • First sales 2016 • Generating Real World Evidence under “PASS” • SCENESSE® PDUFA date 8 July • Profits generated FY2017, FY2018 • Translational use and growth • Orphan indic
Slide 4: Health impacts of environmental and artificial light
Health impacts of environmental and artificial light 100 200 300 400 500 600 700nm <400nm: ultraviolet light 400-700nm: visible light • Acute and chronic skin damage (cancer) • Long-term health impacts • Activates vitamin D production not well understood
Slide 5: Video – erythropoietic protoporphyria
Video – erythropoietic protoporphyria
Slide 6: Erythropoietic protoporphyria (EPP)
Erythropoietic protoporphyria (EPP) • Rare metabolic disorder, 1:140,000 Phototoxic reaction in an EPP patient. Image courtesy of the Koerner family. • Poorly understood and characterised disease • Intolerance to blue/green/UVA/UVB light • Phototoxicity – incapacitating anaphylactoid reactions and b
Slide 7: SCENESSE (afamelanotide 16mg)
SCENESSE® (afamelanotide 16mg) ➢ New molecular entity (NME) ➢ Novel controlled-release injectable implant ➢ Stimulates melanin in skin to protect patients from light, prevent reactions ➢ Dosed every two months in spring and summer • First-in-class application of peptide in treatment therapy for eryt
Slide 8: SCENESSE – Real World Evidence
SCENESSE® – Real World Evidence • European patients in third year of post-authorisation treatment • Data captured under Phase IV “PASS” • Long-term treatment experience from clinical trials to post-authorisation use • Special access schemes since 2010 • >5,100 doses to EPP patients across global pro
Slide 9: Orphan drug addressing unmet need in Europe
Orphan drug addressing unmet need in Europe SCENESSE® accepted as standard of care for EPP in European nations • 17 countries with known EPP patients, product being made available in up to 9 in 2018-19 • Ongoing supply under special access scheme in Switzerland Commercial roll out with dedicated, sp
Slide 10: SCENESSE in vitiligo (1)
SCENESSE® in vitiligo (1) FACTS EFFECTIVENESS MODE OF ACTION CUV103 [2018] • prevalence ~1% CUV102 [2013] Hypothesis 1 - addressable market 20-30% - extent or repigmentation • expression VASI (p<0.025) SCENESSE® + NB-UVB - generalised vs non-segmental - face: time to repigmentation activates • patho
Slide 11: SCENESSE in vitiligo (2)
SCENESSE® in vitiligo (2) Day 0 Day 55 Day 111 Day 176 Baseline After 15 NB-UVB After 27 NB-UVB After 40 NB-UVB treatments, 1 implant treatments, 3 implants treatments, 4 implants
Slide 12: CLINUVEL Group - business growth
CLINUVEL Group - business growth Flow of knowhow on melanocortins Proof of concept - porphyrias (EPP) 1991- 2018 EPP, variegate porphyria • Systemic protection, visible light (>408nm) • Rare disorder 1:140,000 • Global disease registry Most common “side effects”: • nausea, headache, bruising at New
Slide 13: Product Pipeline
Product Pipeline Pre- Programme – SCENESSE® (afamelanotide 16mg) clinical Phase I Phase II Phase III Approved SCENESSE® in adult EPP patients (Europe) SCENESSE® in adult EPP patients (USA) SCENESSE® in adult EPP patients (Australia, Japan) SCENESSE® in adult vitiligo patients (global) SCENESSE® in a
Slide 14: Financials
R&D 2005-2016 COMMERCIAL 2016 ONWARDS Financials - - cost-management equity financing - cost-management - cash positivity - financial proof of principle - profitability - minimum cash reserves - growth - no debt - first dividend FY18 $30.00 60 EPS A$ cents $20.00 40 A$M $10.00 20 $- 0 -$10.00 -20 -$
Slide 15: Summary – CLINUVEL
Summary – CLINUVEL • Pioneers of new medical concept – medicinal photoprotection • Approved orphan product (NME) in Europe – SCENESSE® • First sales 2016 • Generating Real World Evidence under “PASS” • SCENESSE® PDUFA date set for 8 July • Profits generated from EU sales FY2017, FY2018 • Future focu
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