Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Shareholder Meeting (October 2023)
24 slides from Clinuvel Pharmaceuticals's shareholder meeting presentation, Oct 31, 2023
Slide 1: Managing Director's address, Annual General Meeting
For personal use only Managing Director’s address Annual General Meeting ASX CUV Börse Frankfurt UR9 Level 1 ADR CLVLY 31 October 2023
Slide 2: Forward-looking statement
CLINUVEL GROUP Forward-looking statement 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: Catalysts
For personal use only Catalysts
Slide 4: Timelines: next months
Timelines Next 12 months For personal use only use in adolescents – EMA guidance SCENESSE® regulatory filing Canada CUV105, n=200 – complete recruitment Vitiligo CUV107, n=200 CUV151-156 readouts XP – DNA Repair CUV154-158 study start VP CUV040 – study complete CUV803 – readouts (PRÉNUMBRA®) CNS dis
Slide 5: Technology
For personal use only Technology
Slide 6: The technology – melanocortins
The technology – melanocortins COMPANY YEAR* RECEPTOR/S STATUS For personal use only ACTH # 1–24 or 1–39 amino acids Merck 1999 MC4R Abandoned Basilea 2003 MC4R Abandoned Abbvie 2008 MC1R, MC3R, MC4R, MC5R Abandoned Afamelanotide # 1–13 amino acids Novo Nordisk 2014 MC4R Abandoned Zengen 2007 MC1R A
Slide 7: Clinical programs
For personal use only Clinical programs
Slide 8: Pharmaceutical pipeline
Pharmaceutical pipeline For personal use only XP; xeroderma pigmentosum | IS; infantile spasms | MS; multiple sclerosis | CNS; central nervous system.
Slide 9: XP trials – clinical timelines
XP trials – clinical timelines For personal use only 2022 2023 2024 2025 2026 Sep 2023: First readout CUV151 (n = 9; 10 enrolled, HV) 1H 2024: Final results Jan 2022 1H 2024: First readout CUV152 (n = 6, XPC/XPV) 2H 2024: Final results Mar 2022 2H 2024: Final results CUV156 (n = 6, XPC) Oct 2021 CUV
Slide 10: Evaluating XP – DNA Repair – clinical endpoints
Evaluating XP – DNA Repair – clinical endpoints Reducing DNA damage Decreasing photodamage Reducing the risk of skin cancer For personal use only CUV156 CUV151 DNA repair markers • Photoproducts (CPDs) - reduction - reduction at 15 mins (p=0.0039) • γ-H2AX - increase - pending • P53 - variable, incr
Slide 11: Cutaneous porphyrias
Cutaneous porphyrias Erythropoietic protoporphyria Variegate porphyria For personal use only • Expansion for adolescent • CUV040 study ongoing patients • Regulatory assessment – • Single dose study CUV052 SCENESSE® label • Expansion population ~21% Total addressable market: US$300m 2023 2024 2026 1H
Slide 12: Arterial Ischaemic Stroke
Arterial Ischaemic Stroke Targeted product position A hormonal treatment to assist hypoxic brain For personal use only 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 13: Vitiligo – global Phase III study (CUV105)
Vitiligo – global Phase III study (CUV105) CLINUVEL CUV105 Phase III Pfizer pivotal Phase III oral JAK inhibitor* For personal use only 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: Inclusi
Slide 14: Vitiligo – path to market
Vitiligo – path to market Step 1 >15,200 doses afamelanotide administered2 CUV102 • Safety profile accepted For personal use only +NB-UVB n = 56 Step 2 NB-UVB combination CUV103 • program planning resulted in savings $75 – 145M +NB-UVB n = 21 NB-UVB treatment Step 3 2022 FDA – precedent for NB-UVB a
Slide 15: Targeted Technology Translation: PhotoCosmetics
Targeted Technology Translation For personal use only PhotoCosmetics Polychromatic DNA Melanogenesis Photoprotector Protect & Repair = "bronzing"
Slide 16: PhotoCosmetics
PhotoCosmetics Identity & visibility Digital Campaigns For personal use only • architecture • multi-channel • launch events 2024-25-26 • new digital platform • cost of customer acquisition • click through rate (target 3.2%) CYACÊLLE Advocacy • conversion rate (1.8-2.3%) Polychromatic screen • CUVA (
Slide 17: Investor Relations & Finance
For personal use only Investor Relations & Finance
Slide 18: Investor Relations Activities
Investor Relations Activities INVESTOR RELATIONS TEAM For personal use only 1 Australia | 1 Europe | 1 US (pending) | 1 Consultant | 2 External Partners 1 2 3 NDRs by Banks and Brokers Institution and Analyst Meetings CLINUVEL Events Summary of activities FY22 FY23 FY24 Roadshows & conferences 13 9
Slide 19: Registry 2023: CLINUVEL Shareholders by Type
Registry 2023 For personal use only CLINUVEL Shareholders by Type % of Issued Capital, September 2023 Australia and New Private/retail Zealand Institutions Institutions September 2023 • 30 total ANZ institutions Directors & staff • 14.2% of issued capital Corporates & brokers Other, unclassified
Slide 20: Finance
Finance $50 $90 Mkt Cap FY24e FY24e Code Company (A$m) EV/EBITDA P/E For personal use only AUS Established Med Tech Companies* $80 ASX:CSL CSL Limited $113,080.6 16.4x 24.2x $40 ASX:RMD ResMed Inc. $31,170.6 14.1x 18.8x $70 ASX:COH Cochlear Limited $15,887.4 27.1x 43.2x Average 19.2x 28.7x Revenues,
Slide 21: CLINUVEL in 2026
For personal use only CLINUVEL in 2026
Slide 22: Total addressable markets
Total addressable markets For personal use only 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$1.29B M&A TAM US$5.4B TAM US$6.2B Vitiligo ACTH PhotoCosmetics US$490–570M US$150M ~US$60M
Slide 23: Conclusions
Conclusions For personal use only Catalysts next 12 months 16 Prudent fiscal management CAGR 30%, net assets 31%, cash A$156.8 (FYE ‘23) Australian institutions 14% Pharma + PhotoCosmetic Pipeline, commercial launches 2024-25-26 Analyst coverage Independent reports published TAM >US$2B
Slide 24: 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 https://www.clinuvel.com/investors/contact-us www.clinuvel.com Level 11, 535 Bourke Street Melbourne - Victoria, Austral
Clinuvel Pharmaceuticals — Shareholder Meeting (October 2023) on 6ix