Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — H1 FY2026 Earnings Presentation
15 slides from Clinuvel Pharmaceuticals's earnings presentation, Feb 26, 2026
Slide 1: First Half Results FY2026
First Half Results - FY2026 Investor Briefings - February and March 2026 Lachlan Hay, Chief Operating Officer Peter Vaughan, Chief Financial Officer Malcolm Bull, Head of Australian Operations and Investor Relations ASX: CUV | Börse Frankfurt: UR9 | ADR Level I: CLVLY (uplist to Level II in progress
Slide 2: Forward-Looking Statement
FORWARD - LOOKING STATEMENT CLINUVEL GROUP This release contains forward-looking statements, which reflect the current beliefs and U.S., Europe, the UK, Israel, China, Japan, and/or LATAM regions of our agreements with expectations of CLINUVEL’s management. All statements other than statements of hi
Slide 3: Underlying profit maintained
Underlying profit maintained Half year ended 31 December 2025 31 December 20251 31 December 20241 Change Revenues2 36,930,512 35,645,883 +4% Expenses 25,973,539 21,353,011 +22% Profit after tax 10,442,705 14,075,335 -26% Basic earnings per share 0.21 0.28 -26% Cash reserves3 232,999,375 224,105,942
Slide 4: Building a diverse, sustainable global business
Building a diverse, sustainable global business CLINUVEL Key Activities and Outcomes – H1 FY2026 • Expertise in peptides, melanocortins Commercial • Integrated ‘in-house’ business model • EMA2 approved year-round SCENESSE® treatment for EPP • Commercialised SCENESSE® for EPP1 Pipeline • 9½ years rev
Slide 5: A unique business model
A unique business model Melanocortins Peptides / Hormones Long-term safety Controlled-release Formulation Development Inhouse development EXPERTISE Porphyria, vitiligo FISCAL PRUDENCE Clinical Expertise Central nervous system CLINICAL FOCUS Direct distribution >15 countries Commercial Infrastructure
Slide 6: Revenues, expenses and profit
December Half Year (A$m) Revenues, 40 16 expenses 14 30 and profit 12 20 Revenues growth with 10 controlled expansionary 10 expenses underpin 8 consistent and stable 0 earnings 6 -10 4 -20 2 -30 0 Dec 2016 Dec 2017 Dec 2018 Dec 2019 Dec 2020 Dec 2021 Dec 2022 Dec 2023 Dec 2024 Dec 2025 Revenues (LHS
Slide 7: Buoyant revenues
Revenues and Income, December Half Years (A$m) H1-FY26 Buoyant H1-FY25 Revenues H1-FY24 Progressive sales revenues plus H1-FY23 interest income with variable other income contribution H1-FY22 $Am Dec ’25 Dec ’24 H1-FY21 Commercial 33.4 (+3%) 32.6 H1-FY20 SAS 3.5 (+15%) 3.0 H1-FY19 Revenues 36.9 (+4%
Slide 8: Controlled expenses support expansion
Half Year Expenses (A$m) Controlled Expenses Support Expansion Total Expenses 25.97 Half year Dec ’25 expenses increase 22% - 5 10 15 20 25 30 Growth In: Expenses Breakdown (A$m) • Personnel-related (+16%) - 3 6 9 12 15 • Clinical and Non-Clinical Development (+19%) • Commercial distribution (+42%)
Slide 9: Balance sheet strengthens
Cash Reserves and Net Assets (A$m) 250 Balance Sheet 200 Strengthens Enables self-financing 150 expansion Cash Reserves1 of $A233m: • cover OPEX for 3+ yrs 100 • enable continued pipeline development • provide buffer from externalities 50 • finance value-adding asset acquisition Debt-free balance sh
Slide 10: Pipeline: melanocortins
Pipeline: melanocortins Preclinical Phase I Phase II Phase III Commercial SCENESSE® (afamelanotide 16 mg) in adult EPP Europe, CH, USA, ISL, CAN 1 SCENESSE® (afamelanotide 16 mg) in adolescent EPP Filing in H2 2026 SCENESSE® (afamelanotide 16 mg) in adolescent and adult vitiligo Topline results CUV1
Slide 11: Calendar & catalysts
Calendar & catalysts 2026 2027 H1 H2 H1 H2 Health Canada: I SCENESSE® Marketing Authorization decision EMA filing SCENESSE®: adolescent use in EPP CUV105 vitiligo AAD’26 cases presented Top line results Complete results CUV107 vitiligo EMA Scientific Advice Vitiligo CUV107 Ph III → start recruitment
Slide 12: Regulatory strategy vitiligo
Regulatory strategy vitiligo Proof of concept 2026 EMA/FDA IRB/Ethics/DMSB CUV101–102–103 SCENESSE® adjunct NB-UVB Data Monitoring Surveillance Board - CUV105 data lock, data integrity (H2 ‘26) CUV104 SCENESSE® EMA meeting: Scientific Advice (pending) monotherapy - CUV107 protocol validation - adult
Slide 13: Vitiligo U.S. market
1% Prevalence Total addressable market 3,295,000 US$4.5b Vitiligo U.S. Market significant market opportunity Commercial preparation establish systems, NB-UVB 25% Eligible Distribution 823,750 1 national team (20) 40% (0.5% BSA, 0.2% H/N) 329,500 Prescribers target 190 trained & accredited centres 20
Slide 14: Future outlook, clear objectives
Future outlook, clear objectives Vitiligo - significant market US$490m 1 A team which - preparation of distribution systems 20 staff - CUV105 topline results • developed, completed clinical programs - CUV107 start 2H 2026 • commercialised SCENESSE® in EPP EPP - superior technology - long-term treatm
Slide 15: Thank You
Thank You 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, Australia, 300
Clinuvel Pharmaceuticals — H1 FY2026 Earnings Presentation on 6ix