Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — H1 FY2020 Earnings Presentation
18 slides from Clinuvel Pharmaceuticals's earnings presentation, Feb 27, 2020
Slide 1: CLINUVEL Update: Financial Performance and Strategic Initiatives
For personal use only CLINUVEL UPDATE: FINANCIAL PERFORMANCE AND STRATEGIC INITIATIVES Non-Deal Roadshow Melbourne and Sydney, 27-28 February 2020 Darren Keamy Malcolm Bull Chief Financial Officer Head of Investor Relations CLINUVEL Group CLINUVEL Group CLINUVEL PHARMACEUTICALS LTD ASX: CUV Nasdaq I
Slide 2: Legal Notice
LEGAL NOTICE For personal use only This release contains forwards-looking statements, which reflect the current and payment obligations; uncertainties surrounding the legislative and regulatory beliefs and expectations of CLINUVEL's management. Statements may involve a pathways for the registration
Slide 3: Contents
CONTENTS For personal use only 1 5 CLINUVEL: Snapshot Financial Dynamics 2 6 Approved Indication & Treatment Checkpoint in CLINUVEL’s Journey 3 7 Distribution Update Financial Results: Half Year Ended December 2019 4 8 Key Milestones Strategic Initiatives 2020
Slide 4: CLINUVEL: Snapshot
CLINUVEL: Snapshot For personal use only • Specialty pharma Develop and deliver novel treatments for severe genetic & skin disorders (unmet medical need) • Developed and commercialised world’s first systemic photoprotective drug, SCENESSE® (NME) US & EU approved for EPP - rare genetic disorder,
Slide 5: Approved Indication: Erythropoietic protoporphyria (EPP)
Approved Indication: Erythropoietic protoporphyria (EPP) For personal use only • Lifelong metabolic genetic disorder FECH deficiency 18q21 in the haem biosynthesis pathway • Intolerance to light (blue/green/UV, peaking at 408nm) • Phototoxicity – painful anaphylactoid reactions and burns • Cause
Slide 6: Approved Treatment: SCENESSE (afamelanotide)
Approved Treatment: SCENESSE ® (afamelanotide 16 mg) For personal use only • World’s first systemic photoprotective drug • Afamelanotide induces melanogenesis, provides photoprotection • Regulatory approval EU and USA • Injectable implant every 60 days • Rigorous pharmacovigilance EU • Satisfactory
Slide 7: Distribution Update: SCENESSE for EPP
Distribution Update: SCENESSE® for EPP For personal use only European US Journey Operations Pending - Countries - Treatments - Patients - Centres CLINUVEL SELF-DISTRIBUTION MODEL • Long term shareholder return – not diluted by cost of licensing • Relationship development - direct distribution to hos
Slide 8: Key Milestones
Key Milestones For personal use only 2005 • New executive management team, focus on medicinal photoprotection 2006 • First EPP study, Switzerland 2007 • First cross-over design study 2009 • IND approved by US FDA, commenced confirmatory Phase II/III studies USA/EU, first EPP study published in New E
Slide 9: Financial Dynamics
R&D 2005-2016 COMMERCIAL 2017-2019 Financial Dynamics - cost-management - cost-management For personal use only - self-arranged equity financing - cash positive - never below critical cash - profitable - financial proof of principle 2010 - debt-free - R&D cost SCENESSE®, A$153.5m - dividend FY18 & F
Slide 10: Checkpoint in CLINUVEL's Journey
Checkpoint in CLINUVEL’s Journey For personal use only • Progressing a longstanding strategy • European business generated record profit (A$18.1m FY19) • Positioning for sustainability by investing in the business to support future growth • FDA approval (October 2019) of SCENESSE® for EPP enables:
Slide 11: Financial Results: Half Year Ended December 2019
Financial Results: Half Year Ended December 2019 For personal use only • Revenues Key Financials December December Change, % 11% growth 2019 2018 Revenues, $m 9.971 8.981 +11 • Expenses Expenses, $m 8.741 5.683 -54 Increased investment across the business, including manufacturing NPBT, $m 1.059
Slide 12: Eighth Consecutive Half Year Profit Since SCENESSE EU Launch
Eighth Consecutive Half Year Profit Since SCENESSE® EU Launch For personal use only A$ m 25.00 20.00 15.00 10.00 5.00 0.00 2015 2016 2016 2017 2017 2018 2018 2019 2019 Dec Jun Dec Jun Dec Jun Dec Jun Dec -5.00 Expenses Revenues NPBT Total revenues from operations, excludes other income. NPBT include
Slide 13: Revenue Analysis: Half Year Comparison
Revenue Analysis: Half Year Comparison For personal use only Revenues, A$ m • Robust growth continues 25 11% by value 7% by volume 20 Dampened by timing of orders 15 • Price stable, some exchange rate impact • Seasonally lower half 10 5 • Stable retention of patients in countries supplied 0 20
Slide 14: Expense Analysis: Half Year Comparison
Expense Analysis: Half Year Comparison For personal use only Expenses, A$ m % Breakdown of Incremental Expenses 10.00 9.00 Other Drug 8.00 12% Formulation, 7.00 Increase of Manufacturing and Distribution A$3.06m 16% 6.00 5.00 Regulatory and 4.00 Commercial Overheads 3.00 15% General 2.00 Administrat
Slide 15: Strategic Initiatives 2020
Strategic Initiatives 2020 For personal use only GROWTH EUROPE EXPANSION USA PROGRESS PIPELINE INORGANIC GROWTH • Fourth year of • CEO lead executive • EPP • Open to value implementation New regulatory commercial team approvals adding operations • Establish Business Paediatric formulation opport
Slide 16: SCENESSE for Vitiligo
SCENESSE® for Vitiligo For personal use only 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 17: Product Pipeline
Product Pipeline For personal use only • EPP • Topicals TGA reviewing SCENESSE® for Focus of Singapore subsidiary, EPP in Australia VALLAURIX Developing paediatric Pharmaceutical application for formulations vitiligo Developing OTC skin care products • Vitiligo • Medicinal Type C Guidanc
Slide 18: Thank You...Questions
For personal use only THANK YOU …Questions Darren Keamy Malcolm Bull Chief Financial Officer Head of Investor Relations CLINUVEL Group CLINUVEL Group Level 11, 535 Bourke Street Melbourne, VIC 3000, Australia Authorised for ASX release: Managing Director on behalf of CLINUVEL PHARMACEUTICALS LTD CLI
CLINUVEL Pharmaceuticals — H1 FY2020 Earnings Presentation on 6ix