Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Non-Deal Roadshow (March 2019)
15 slides from Clinuvel Pharmaceuticals's roadshow presentation, Mar 4, 2019
Slide 1: The Next Growth Phase – Investor Briefing
For personal use only THE NEXT GROWTH PHASE Investor Briefing – Non-Deal Roadshow March 2019 Melbourne – Sydney CLINUVEL PHARMACEUTICALS LTD ASX: CUV Darren Keamy, Chief Financial Officer Nasdaq Int’l: CLVLY Malcolm Bull, Investor Relations Manager Xetra-Dax: UR9
Slide 2: Safe harbour statement
Safe harbour 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 to d
Slide 3: Contents
Contents For personal use only 1 Company Overview 5 FY2019 Half Year 2 Execution of a Vision 6 What’s Next? 3 Foundations: Photoprotection, EPP & SCENESSE 7 Product Pipeline 4 Financials 8 Summary
Slide 4: Company Overview
Company Overview For personal use only • Developing and delivering treatments for patients with severe genetic and skin diseases • Leader in melanocortins and expert in interaction of “light” and “skin” • Foundations of business established ➢ Navigated from R&D pharmaceutical product development to
Slide 5: Execution of a Vision
Execution of a Vision For personal use only Experienced and Cohesive Board Experienced, Skilled, Committed Management & Staff Board & Management Technology, Respect & Appreciation, People & Principal Values Environment, Approach, Knowledge Building & Sharing To excel in scientific innovation in Visi
Slide 6: Medicinal photoprotection
Medicinal photoprotection For personal use only Proof of concept in porphyrias (EPP) EPP • Systemic photo protection to visible light (>408nm) • Rare disorder 1:140,000 • Global disease registry Variegate porphyria & Photoprotection, DNA repair 2nd indication Q1’19 Systemic repigmentation (total bod
Slide 7: SCENESSE for EPP
SCENESSE for EPP For personal use only • Erythropoietic protoporphyria (EPP) ➢ Rare genetic disorder, affecting 1:140,000 ➢ Expressed as severe phototoxic “burns” and anaphylactoid reactions to light (~408nm) • SCENESSE (afamelanotide 16mg) ➢ Novel controlled release injectable implant ➢ Activates
Slide 8: SCENESSE Pathway to Market
SCENESSE Pathway to Market For personal use only • December 2014 – European Commission ratified marketing authorisation in Europe Patient Testimonials: • June 2016 – product launch EU ➢ “SCENESSE has really changed my life!” • Safety focus Risk Management Plan & registry – rigorous pharmacovigilan
Slide 9: Financials
R&D 2005-2016 COMMERCIAL 2016 ONWARDS Financials - - cost-management equity financing - cost-management - cash positivity For personal use only - financial proof of principle - profitability - minimum cash reserves - growth $30.00 60 - no debt $20.00 40 EPS A$ cents $10.00 20 A$M $- 0 -$10.00 -20 -$
Slide 10: FY2019 Half Year results
FY2019 Half Year results For personal use only • The 6 months to 31 December 2018 were positive for CLINUVEL: ➢ Revenues, $8.981m, up 27% on 6 months to December 2017 ➢ Expenses ($5.683m) responsibly managed in growth phase of the business ➢ Net Profit, $4.076m, up 189% on 6 months to December 2017
Slide 11: What's Next?
What’s Next? 1. EU Expansion For personal use only ➢ Additional expert centres to meet patient & physician demand 2. US Expansion ➢ PDUFA date – 8 July 2019 ➢ Approval would potentially double our EPP addressable market ➢ Replicate EU operating model 3. Ongoing Progression of our Development & Regul
Slide 12: Product Pipeline
Product Pipeline For personal use only 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 (
Slide 13: SCENESSE in vitiligo
SCENESSE® in vitiligo For personal use only FACTS EFFECTIVENESS MODE OF ACTION CUV103 analyses in progress • prevalence ~1%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
Slide 14: SCENESSE world's first systemic photoprotective
SCENESSE® NME world’s first systemic photoprotective - Human volunteers: melanogenesis 1988-2019 - reduction in apoptotic epidermal cells EPP VP For personal use only - EPP: reduction in phototoxicity reduction in anxiety, increased freedom EFFECTIVENESS - Solar Urticaria: reduction in wheal formati
Slide 15: Summary
Summary For personal use only 1. Foundations for growth established 2. Profit Trending Upward 3. Growth Outlook 4. 8 July 2019 – FDA: PDUFA date
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