Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — H1 FY2025 Earnings Presentation
19 slides from Clinuvel Pharmaceuticals's earnings presentation, Feb 27, 2025
Slide 1: Financial and Operational Performance, six months to 31 December 2024
For personal use only Financial and Operational Performance, six months to 31 December 2024 February / March 2025 Peter Vaughan, Chief Financial Officer & Malcolm Bull, Head of Investor Relations & Australian Operations 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: Strong Underlying Profit
Strong Underlying Profit Half year ended 31 December 2024 For personal use only 31 December 2024 31 December 2023 Change REVENUES ($) 35,645,883 32,256,885 +10.5% EXPENSES ($) 21,353,011 20,924,198 +2.0% PROFIT BEFORE TAX ($) 21,932,314 14,805,699 +48.1% PROFIT AFTER TAX ($) 14,075,335 10,936,043 +2
Slide 4: Buoyant Revenues
Buoyant Revenues Progressive rise in revenues from sales plus interest and other income For personal use only REVENUES AND INCOME, DECEMBER HALF YEARS ($m) $m Dec ’24 Dec ’23 Commercial 32.6 (+9.2%) 29.9 H1-FY25 H1-FY24 SAS 3.0 (+26.6%) 2.4 H1-FY23 H1-FY22 Interest 4.6 (+26.1%) 3.7 H1-FY21 Other 3.0
Slide 5: Controlled Expenses Support Expansion
Controlled Expenses Support Expansion Half year Dec ’24 expenses contained to 2% increase For personal use only HALF YEAR EXPENSES ($m) GROWTH IN: • Personnel related (+34.0%) Total Expenses • Clinical and Non-Clinical Development (+277.4%) - 2 4 6 8 10 12 14 16 18 20 22 • Commercial distribution (+
Slide 6: Revenues, Expenses and Profit
Revenues, Expenses and Profit Revenues growth and controlled expenses underpin earnings growth For personal use only • All revenues from distribution of REVENUES, EXPENSES AND PROFIT SCENESSE® for EPP 45 DECEMBER HALF YEAR ($m) 24 • Consecutive half year revenues growth 35 since commencement of comm
Slide 7: Balance Sheet Strength
Balance Sheet Strength Enables self-financing expansion For personal use only TOTAL ASSETS, CASH RESERVES AND NET ASSETS ($m) $m 31 Dec ’24 30 Jun ’24 250 Total Assets 236.2m (+2.2%) 231.1m Cash Reserves 198.2m (+7.8%) 183.9m 200 • covers OPEX for 2-3 yrs • enables continued pipeline development • p
Slide 8: Focused Expansion strategy
Focused Expansion strategy For personal use only Integration of key functions ‘in-house’ Melanocortin product Translation of technology Distribution SCENESSE® development, clinical studies to PhotoCosmetic products M&A Focus on increasing patients, PRÉNUMBRA® 1. Polychromatic screen Vertical integra
Slide 9: Key Outcomes
Key Outcomes Half Year to December 2024 For personal use only Objective Progress Building long-term • Strong financial performance achieved – highest 1HFY underlying profit to • Prioritisation of strategic programs: vitiligo, ACTH & porphyrias value date SCENESSE® • Board renewal:EPPthree new Non-Ex
Slide 10: Catalysts 2025
Catalysts 2025 For personal use only Objective Event Growing commercial distribution of • Engagement EMA on CUV052 and adolescent EPP patient use of SCENESSE® SCENESSE® for EPP • EMA decision on SCENESSE® dosage for EPP patients • Expand to 120 North American Specialty Centers • Health Canada decisi
Slide 11: Vision of the Future
Vision of the Future A house of melanocortins For personal use only A pharmaceutical group, diversified and integrated to sustain long-term performance Products, indications & healthcare solutions • 3 pharmaceutical products • 5 conditions treated TAM >$300m • 3 PhotoCosmetic product lines PORPHYRIA
Slide 12: For personal use only
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Slide 13: NB-UVB – follicular repigmentation
NB-UVB – follicular repigmentation NB-UVB differentiating For personal use only Hair follicle follicular stem cells Epidermis Melanoblasts migrating, become fully functioning melanocytes Afamelanotide acting as agonist to MC1R expressed Dermal NB-UVB [308-313nm] sheath Bulge/Niche Dermis Day 0 Basel
Slide 14: CUV102 Phase II study results
CUV102 Phase II study results Day 0 Baseline For personal use only Day 35 15 treatments/1 implant Day 66 29 treatments/2 implants Day 171 62 treatments/4 implants Day 0 Day 111 Day 179 Baseline 27 treatments/3 implants 40 treatments/4 implants Images have been amended/cropped and pixelated to protec
Slide 15: CUV105 Phase III study – first clinical observations
CUV105 Phase III study – first clinical observations CASE REPORT 1 CASE REPORT 2 • Female, 55 years old, Skin Type IV • Male, 52 years old, Skin Type IV • Diagnosed with vitiligo in 2006, slowly progressive disease activity, no previous • Diagnosed with vitiligo in 2023, progressive disease activity
Slide 16: CUV105 Phase III study – first clinical observations
CUV105 Phase III study – first clinical observations CASE REPORT 3 CASE REPORT 4 • Male, 56 years old, Skin Type IV • Male, 56 years old, Skin Type IV • Diagnosed with vitiligo in 1999 • Diagnosed with vitiligo in 1986 For personal use only Physician’s report Physician’s report First repigmentation
Slide 17: Vitiligo: Path to market
Vitiligo Path to market, affects 1-2% of global population For personal use only CUV102 +NB-UVB, n = 56 Step 1 Safety profile established • >17,000 doses afamelanotide administered 2 Step 2 CUV102, CUV103, CUV104 CUV103 +NB-UVB, n = 21 Step 3 2022: FDA set precedent for NB-UVB combination therapy St
Slide 18: Vitiligo: Addressable Market USA
Vitiligo Addressable Market USA – afamelanotide for FST IV-V-VI For personal use only INCIDENCE FST IV-V-VI ELIGIBLE FOR Tx SEEKING Tx PENETRATION 7–8 doses pp for >90% repigmentation No. 3,295,000 823,750 329,500 65,900 5,931 Revenues, yr 1–2 US$490 – 570m 40% 9% yr 1–2 0.5% BSA 20% 0.2% H&N 25% 1%
Slide 19: For personal use only
For personal use only 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 Street, Melbourne – Victoria, Au
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