Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Investor Day (May 2024)
47 slides from Clinuvel Pharmaceuticals's investor day presentation, May 1, 2024
Slide 1: From Orphan to Large
For personal use only From Orphan to Large CAPITAL MARKET S BRIEFING Strategic Update VIII | Sydney, 01 May 2024 ASX: CUV | Börse Frankfurt: UR9 | ADR Level 1: CLVLY
Slide 2: Forward-looking statement
Forward-looking statement CLINUVEL GROUP 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, o
Slide 3: Introduction
For personal use only Introduction Malcolm Bull
Slide 4: From Orphan to Large
From Orphan to Large For personal use only 09:00 Introduction 09:05 Chairman 09:10 Commercial Update 09:35 R&D Pipeline 10:00 Break 10:20 Focus on Vitiligo, Stroke & DNA Repair 11:10 Diversification Strategy and Decision-Making 12:00 Q&A 12:45 Buffet Lunch 14:00 Close
Slide 5: Chairman
For personal use only Chairman Prof Jeffrey Rosenfeld
Slide 6: Longevity
Longevity For personal use only Board Executive Management Management (5) (9) (10) median tenure 4.4 yrs median tenure 14.9 yrs median tenure 4.5 yrs Integrated skill set Accountancy, bookkeeping, legal, investor relations 12 Medicine, pharma. sciences, chemistry, engineering 52 Gen mgmt., comms, ba
Slide 7: Commercial Update
For personal use only Commercial Update Lachlan Hay
Slide 8: SCENESSE (afamelanotide) for EPP
SCENESSE® (afamelanotide) for EPP For personal use only 2006 Ph II CUV010 commences 2007 Ph III CUV017 commences 2009 CUV010 published NEJM 2010 Italian 648/96 – first reimbursement 2011 Ph III CUV029 completed R&D ‘06-’15 SCENESSE® first-in-class (EMA-FDA) 2012 Swiss Special Access (reimbursed) lau
Slide 9: Traditional US commercial model
Traditional US commercial model For personal use only Insurance contract PAYERS PATIENTS ~1,100 private Premium government Copayment Dispensed drugs Prime Vendor Agreement PHARMACIES Shipped bulk drugs PHARMACY Payment for dispensed drugs Payment for wholesale drugs BENEFITS DISTRIBUTOR MANAGER Form
Slide 10: CLINUVEL's US commercial model
CLINUVEL’s US commercial model For personal use only Insurance contract PAYERS PATIENTS >100 private, government Payment SPECIALTY EPP Patient Assistance Program (private patients) CENTERS Drug shipment Product Funds Contracting CLINUVEL
Slide 11: US Commercial Infrastructure
US Commercial Infrastructure Direct Distribution 2019–2024 For personal use only In-house commercial team Logistics Medical centers Director, Nth American Operations DC – cold storage orders Financial specialists labelling / packaging pharmacy storage VA-Medicare-Medicaid QA Rx filled Patient liaiso
Slide 12: SCENESSE (Rx) for EPP: Continued growth 2016-2024
SCENESSE® (Rx) for EPP For personal use only Continued growth 2016-2024 CLINUVEL self-distributing EU-USA-ISL $80 • 7% increase filled prescriptions (CY23 vs CY22) • 4% volume growth (1H FY24 vs 1H FY23) $60 Distribution agreement in new region negotiated $40 Revenues >A$330m since launch (June 2016
Slide 13: North American distribution 2020-2024
North American distribution 2020-2024 For personal use only Patient centricity Objective: 3–4hrs access (cluster distribution) 95% access for patients (pursued PA process) 80 Specialty Centers (trained and accredited) 30 States 100+ private insurers CMS, VA CPT® code (11981) & J-Code (J7352) establi
Slide 14: European distribution 2016-2024
European distribution 2016-2024 For personal use only CY23 highest number of patients treated 95% treatment continuation (2022-23)* In our clinical experience afamelanotide treatment is FY24 5 new European EPP Expert Centres EMA submission label expansion much more effective in clinical practice tha
Slide 15: SCENESSE for adolescent EPP
SCENESSE® for adolescent EPP For personal use only EU+US regulatory pathway 7 adolescents (15-17 yrs) off-label treatment - ≥4 implants - fully reimbursed Estimated 60 patients (15-17 yrs) FR-DE-NL-IT CUV052 pharmacokinetic study underway • (n=28), 9 patients treated • first results in 2024
Slide 16: Attempts to date
Attempts to date For personal use only Experimental therapies Target, endpoint focus Status Use largely discontinued, deployed in absence of Beta carotene Anti-oxidant, no RCT therapy access (i.e. paediatric) Lack of clinical, academic support for use, lack Cimetidine, H2-receptor antagonist Inhibit
Slide 17: R&D Pipeline
For personal use only R&D Pipeline Dennis Wright
Slide 18: Melanocortin peptides for skin and brain
Melanocortin peptides for skin and brain For personal use only Afamelanotide (α-MSH analogue) Adrenocorticotropic hormone (ACTH) SCENESSE® & PRÉNUMBRA® NEURACTHEL® Photoprotective Assist DNA repair Anti-inflammatory Anti-oxidative Anti-oncotic Immune modulation Melanogenesis (bronzing, repigmentatio
Slide 19: Pharmaceutical Pipeline
Pharmaceutical Pipeline For personal use only Preclinical Phase I Phase II Phase III Commercial SCENESSE® (afamelanotide 16 mg) in adolescent EPP (EEA, UK, CH, USA, ISL, CAN, AUS) SCENESSE® (afamelanotide 16 mg) in adolescent EPP SCENESSE® (afamelanotide 16 mg) in adolescent and adult vitiligo SCENE
Slide 20: NEURACTHEL
NEURACTHEL® For personal use only Unmet needs with adrenocorticotropic hormone (ACTH) Manufacturing agreements (2, exclusive) Analytical methods advanced DMF in development Generic (Instant), Branded (Modified-release) in development sNDA submission 2026 Clinical program planned for 1. West Syndrome
Slide 21: Vitiligo
For personal use only Vitiligo Dennis Wright
Slide 22: NB-UVB – follicular repigmentation
NB-UVB – follicular repigmentation For personal use only NB-UVB differentiating Hair follicle follicular stem cells Epidermis Melanoblasts migrating, become fully functioning melanocytes Dermal NB-UVB [308-313nm] sheath Afamelanotide acting as agonist to MC1R expressed Bulge/Niche Dermis Day 0 Basel
Slide 23: Vitiligo: Path to market
Vitiligo Path to market For personal use only CUV102 +NB-UVB n = 56 Step 1 >15,600 doses afamelanotide administered • Safety profile accepted Step 2 NB-UVB combination CUV103 +NB-UVB n = 21 • program planning resulted in savings $75 – 145M Step 3 2022 FDA – precedent for NB-UVB as combination therap
Slide 24: Vitiligo: Global Phase III study (CUV105)
Vitiligo Global Phase III study (CUV105) For personal use only CLINUVEL CUV105 Phase III Pfizer pivotal Phase III oral JAK inhibitor* N=200, adults and adolescents (≥12 years) Study population highest unmet need: darker skin (Fitzpatrick IV-VI) ≥0.3% body surface area with facial vitiligo: Inclusion
Slide 25: SCENESSE (afamelanotide) for vitiligo
SCENESSE® (afamelanotide) for vitiligo For personal use only Case study presented to 2024 American Academy of Dermatology (FST IV) Day 0 Day 134 baseline 7 implants, 39 NB-UVB sessions Images have been amended/cropped and pixelated to protect the patient’s privacy but are otherwise unaltered. Images
Slide 26: SCENESSE (afamelanotide) for vitiligo
SCENESSE® (afamelanotide) for vitiligo For personal use only Case study presented to 2024 American Academy of Dermatology (FST IV) Day 0 Day 134 baseline 7 implants, 39 NB-UVB sessions Images have been amended/cropped and pixelated to protect the patient’s privacy but are otherwise unaltered. Images
Slide 27: SCENESSE (afamelanotide) for vitiligo
SCENESSE® (afamelanotide) for vitiligo For personal use only Case study presented to 2024 American Academy of Dermatology (FST IV) Day 0 Day 134 baseline 7 implants, 39 NB-UVB sessions Images have been amended/cropped and pixelated to protect the patient’s privacy but are otherwise unaltered. Images
Slide 28: CNS
For personal use only CNS Philippe Wolgen
Slide 29: Arterial Ischaemic Stroke
Arterial Ischaemic Stroke Targeted product position For personal use only 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: > M1 • functional recovery in 5
Slide 30: DNA Repair
For personal use only DNA Repair Philippe Wolgen
Slide 31: The Photomedicine Foundation
The Photomedicine Foundation For personal use only
Slide 32: Evaluating XP – DNA Repair – objectives
Evaluating XP – DNA Repair – objectives For personal use only Reducing DNA damage Decreasing photodamage Reducing the risk of skin cancer 29 April 2024 Afamelanotide granted ODD in Europe - first clinical data on efficacy • potential to “extend” label - lack of therapy, • reduction in fees - high un
Slide 33: Evaluating XP – DNA Repair – clinical endpoints
Evaluating XP – DNA Repair – clinical endpoints For personal use only CUV156 CUV151 DNA repair markers • ‘photoproducts’ (CPDs) - reduction - reduction at 15 mins (p=0.0039) • γ-H2AX - increase - reduction at 24 hours (p=0.0078) • P53 - variable, increase - no change • Ki67 - no change Quality of li
Slide 34: Decision Model & Diversification Strategy
For personal use only Decision Model & Diversification Strategy Philippe Wolgen
Slide 35: CUV Construct
CUV Construct For personal use only foreclosure MELANOCORTIN HOUSE 2016–2023 CAGR 30% 2005 – 2024 1. focus resources <A$140M equity Porphyria XP Stroke 2. platform technology “MC peptides” 3. specialists inhouse train & retain Vitiligo ACTH PhotoCosmetics 4. profits accruing A$175M M&A
Slide 36: CUV Differentiated Decision Model
CUV Differentiated Decision Model For personal use only NEUROPEPTIDES no alternative or significant improvement | life threatening or severe | academic/clinical belief | reimbursable TECHNOLOGY PROOF OF PRINCIPLE $$ Ph III COMMERCIALISATION 1. SEVERE/LIFE-THREATENING – Brain 2. EXTREME CONDITIONS –
Slide 37: Risk Management
Risk Management For personal use only Global Biopharmaceutical Market US$1.7 trillion* New compounds 1:5,000–10,000 | 9,000 products in clinical development | 21,000 compounds** (406,000 centres) 13.8% success rate: Meeting objectives (endpoints) Objectives Risk & Complexity Cost Comparison 1. reduc
Slide 38: Longitudinal Valuation CUV
Longitudinal Valuation CUV For personal use only A$m CLINICAL REGULATORY COMMERCIAL EXPANSION 2000 1000 0 2025 2026 2027 2028 Financial POC EMA approval Profit FDA approval FINANCIAL STRENGTH 1. Phase III vitiligo – commercial 2. DNA repair 3. Neurodegenerative Disease 4. PhotoCosmetics 5. Manufactu
Slide 39: Controlled Expenses
Controlled Expenses Tracking 5-year expense projections 2021–2025 For personal use only • A$175 million expenses (5-yrs to Jun ’25) 180 A$175m • cumulative expenses on track 160 NEW 5YR (65% of plan: 18 months remaining) 140 BUDGET • expenses rose 28% - half year ‘23 cf. ‘22) 120 • excludes capital
Slide 40: Earnings Growth
Earnings Growth For personal use only June Year, A$m 30 June 2023 90 50 • 7 yrs annual growth - revenues, profits, net cashflow 75 • 6 yrs annual dividends (< 5% of NPAT) 40 • cash reserves financing expansion 60 • earnings per share A$0.62 45 30 • return on equity 19% 30 15 20 Half Year to December
Slide 41: Strong Balance Sheet
Strong Balance Sheet For personal use only Assets versus Liabilities, A$m Cash Reserves, A$m AS OF 30 Jun ’23 31 Dec ‘23 225 180 Total Assets $193.7m $211.7m 200 160 Total Liabilities $29.1m $33.0m 175 140 • no debt 150 120 Net Assets $164.6m $178.7m 125 100 Cash Reserves $156.8m $174.5m 100 80 • cy
Slide 42: Communication Strategy
Communication Strategy For personal use only PHARMACEUTICAL PHOTOCOSMETIC Impressions ~110M OVER 3 YEARS TARGETS Followers ~1M Conversion Per Campaign 0.9% Institutional / Retail ~30% Active Database ~5M Family Office / UHNWI ~25% A BRAND
Slide 43: Establishing a Brand
Establishing a Brand PHARMACEUTICAL PHOTOCOSMETIC For personal use only CORE TECHNOLOGY melanocortins PHOTOPROTECTION chemistry INNOVATION DNA ASSISTED REPAIR formulations safety DATA efficacy SELF-BRONZING Medical Community Malibu Event Analysts 3.4m Instagram ASX 8,300 CUV Instagram News Communiqu
Slide 44: The Future
The Future For personal use only MELANOCORTIN HOUSE TAM>US$44b | Penetration >US$2b TAM US$300m TAM US$100m TAM US$31b Porphyria XP Stroke FY23 US$53m ~US$50m US$1.98-2.23b TAM US$4.5b TAM US$1.29b TAM US$6.2b Vitiligo ACTH PhotoCosmetics US$490-570m US$150m US$60m M&A
Slide 45: Objectives CY 2024
Objectives CY 2024 For personal use only 1 SCENESSE® adolescent outcome EMA 9 VP CUV040 complete results – March 2024 2 SCENESSE® Canada Health submission 10 CNS CUV803 completed with final results 3 Vitiligo CUV105 completion recruitment 11 CNS and/or New Indication 4 Vitiligo CUV107 start recruitm
Slide 46: Q&A
For personal use only Q&A with the audience CLINUVEL Chair and Executives
Slide 47: Thank you for your attendance
For personal use only Thank you for your attendance 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 Level 22, 535 Bourke St