Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Shareholder Meeting (November 2021)
19 slides from Clinuvel Pharmaceuticals's shareholder meeting presentation, Nov 10, 2021
Slide 1: CEO's Address
For personal use only CEO’s Address CLINUVEL PHARMACEUTICALS AGM 2021 While the world was dominated by the pandemic, the FY 2021 has been very positive for CLINUVEL’s patients continuing SCENESSE® (afamelanotide 16mg) treatment. The performance of the Company outstripped expectations, while the Grou
Slide 2: Legal Notice
Legal Notice This release contains forward-looking statements, which reflect the current beliefs and intentions of CLINUVEL’s management. Statements may involve a number of known and unknown risks that could cause our future results, performance, achievements or output to differ significantly from t
Slide 3: Mission & Objectives
Mission & Objectives Establishing a specialty pharmaceutical group which is For personal use only diversified, vertically integrated, and which serves unmet patient and healthcare needs. We aim to provide a safe and accountable environment, where our staff are able to grow, thrive and build a career
Slide 4: Business Differentiation
Business Differentiation Specialty Pharmaceuticals Risk Management Value Chain Finance Healthcare Solutions Human Capital For personal use only Value Creation Resources Proprietary Technology Position Defined Expertise Opportunity Unserved Populations 4 The basis of our business is found in our focu
Slide 5: Value Chain
Value Chain For personal use only The value chain in pharmaceuticals has become a much discussed subject. Economic conditions have urged companies to rethink the management of procurement, sourcing and supply of raw materials, all the way to product development and distribution. CLINUVEL has gradual
Slide 6: Global Leadership in Photomedicine
For personal use only What We Know…….. What We Do…………. What we Solve……… Solar Radiation UVR + HEV DNA Damage Skin Cancers …Global Leadership in Photomedicine As a specialty pharmaceutical group we develop, we learn, and we progress, all with one objective: to solve critical problems for larger popul
Slide 7: Erythropoietic Protoporphyria (EPP) and SCENESSE
Genetics • prevalence 1:140,000 • chromosomal defects: 18q21, FECH deficiency Erythropoietic • defect in haem synthesis Clinical Profile Protoporphyria • intolerance to UV-HEV = 320 – 450 – 650 nm (EPP) • phototoxicity – anaphylactoid reactions • isolated life, indoors existence Absolute Therapy Int
Slide 8: Xeroderma Pigmentosum (XP)
Genetics Xeroderma • prevalence 1:250,000 to 1,000,000 Pigmentosum • chromosomal defects: XPC: on 3p25.1 (XP) XPV: on 6p21.1 • defective in DNA repair: nucleotide excision repair (NER) Inability to repair DNA Clinical Profile skin damage For personal use only • highest risk of exposure to UV-HEV
Slide 9: XP Clinical Trial Design (CUV156)
XP CLINICAL TRIAL DESIGN (CUV156) XP Clinical Trials Start date: 21 October 2021 Program Duration: 6-9 months 2021-22 • open label study of 6 adult patients: XP-C • multiple dosing with afamelanotide For personal use only • analyses of afamelanotide treatment - safety (systemic/cutaneous) - anti-oxi
Slide 10: Global Leadership in Photomedicine
Global Leadership in Photomedicine For personal use only Intervention at in situ or progressive stage CLINUVEL’s choice is to address the risk factors before skin cells convert to a precancerous state and/or proliferate to skin cancers. The reduction of UV and HEV damage, plus the ability to assist
Slide 11: Global Leadership in Photomedicine: Pharmaceuticals and Healthcare Solutions Divisions
Global Leadership in Photomedicine DIVISION OF PHARMACEUTICALS DIVISION OF HEALTHCARE SOLUTIONS Rx Product Lines OTC Product Lines For personal use only Photomedicine, DNA Repair Program Polychromatic Photoprotection, Assist DNA Repair • Focus on highest unmet medical need: Xeroderma Pigmentosum Foc
Slide 12: Addressable communities
Addressable communities In 2020, there were 120,774 deaths due to skin cancer.1 An estimated 5.4 million non-melanoma skin cancers and EXTREME OUTDOORS IMMUNE-SUPRESSED SKIN CANCER HISTORY >100,000 melanomas are diagnosed in the USA each year.2 For personal use only • 153,863 organ • 35-55% of peopl
Slide 13: Reaching our addressable audience
Reaching our addressable audience • To connect and unite our diverse and disparate communities we must go where they go and be where they are – join their digital world with a common purpose of reducing the number of skin cancers globally. • As far back as 2015 ‘A positive effect of Social Networkin
Slide 14: Global Leadership in Photomedicine
Global Leadership in Photomedicine For personal use only It is illustrated how the triptych EPP – XP – Highest Risk Populations (HRP) form the basis of CLINUVEL’s leadership in photomedicine. From pharmaceuticals to wider audiences at highest need of photoprotection: a logical progression based on s
Slide 15: Clinical Development
Clinical Development For personal use only Vitiligo Variegate Arterial New Porphyria Ischaemic Indication CUV104 [2022] CUV040 Stroke CUV901 • patients of darker CUV801 (n=6) • confirmed skin types biochemical • awaiting (Fitzpatrick IV-V) diagnosis • safety confirmed, administrative no cerebral adv
Slide 16: Specialty Pharmaceutical: Portfolio of melanocortins
Specialty Pharmaceutical: Portfolio of melanocortins 1. Afamelanotide SCENESSE® | adults | solid | in production | EPP, XP, vitiligo SCENESSE® Enfance | paediatric 12-17 | liquid | in development | EPP, XP, vitiligo For personal use only PRÉNUMBRA® Instant | all ages | liquid | in production | strok
Slide 17: Financial Discipline
Financial Discipline Start commercial operations 2016 For personal use only As the Company progressed, the rate of reinvestment has consistently increased. More than 40% of CLINUVEL’s revenues were put towards innovation, research and development in 2020 to 2021. The rate of reinvestment is only pos
Slide 18: Finance: Planned Expenditures FY2021-2025
Finance Planned Expenditures – FY2021-2025 (A$000) Expenditures – excluding CAPEX – presented may deviate from actuals depending on changing business needs and/or model CLINUVEL does not provide financial guidance. • EPP children For personal use only Leadership • XP photomedicine • 3 OTC product li
Slide 19: Thank you
We thank CLINUVEL’s long-term supporters, For personal use only Board of Directors and most of all our highly committed staff Authorised for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTD About CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; NASDAQ INT
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