Clinuvel Pharmaceuticals Limited · ASX:CUV

Clinuvel Pharmaceuticals — Investor Presentation (October 2022)

15 slides from Clinuvel Pharmaceuticals's investor presentation, Oct 14, 2022

  1. Slide 1: Welcome to the Sydney Soirée

    For personal use only Welcome to the PRESENTERS Malcolm Bull – Head of Australian Operations & Investors Relations Lachlan Hay – Director of Global Operations Philippe Wolgen – Chief Executive Officer ASX: CUV XETRA-DAX: UR9 Level 1 ADR: CLVLY clinuvel.com news.clinuvel.com SYDNEY SOIRÉE

  2. Slide 2: Forward-Looking

    Forward-Looking 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 or achievements to differ s

  3. Slide 3: Business

    Business For personal use only SYDNEY SOIRÉE

  4. Slide 4: Financials

    Financials For personal use only FY’22 dividend: 10% of net profit <300% dilution ROCE 27% (6yrs) Cash reserves: AUS $121m (30 June ‘22) Expenses: AUS $175m (FY ‘21-25) AUS $55.5m (FY ‘21-22) Nasdaq ’22* Bio-pharmaceuticals Profitable Main board 798 67 (8.4%) NBI 274 25 (9.1%) ASX 91 3 (3.2%) SYDNEY

  5. Slide 5: Beneficial Ownership

    Beneficial Ownership For personal use only Global distribution • 2/3rd – held EU / US / AS • 1/3rd – held Aust / NZ Aust / NZ share increased, ’18 – ’22 Europe • institutions from 2.9% to 14% ADTV has increased North America Asia & other Australia & New Zealand SYDNEY SOIRÉE

  6. Slide 6: Vitiligo

    Vitiligo For personal use only Image courtesy HF Image courtesy HF Differential diagnosis • post-traumatic hypopigmentation • tinea versicolor • tuberosclerosis • hypomelanocytosis • guttate hypomelanosis • nevus depigmentosus Image courtesy Agarwal • pitriasis alba SYDNEY SOIRÉE

  7. Slide 7: Pathogenesis Vitiligo

    Pathogenesis Vitiligo – For personal use only Mechanism Impact of melanocyte Markers Neural ‘59 sympathetic neuronal NPY, VIP, CGRP, PGP, NGF system Intrinsic deficiency in melanocytes bFGF, c-kit Biochemical, apoptosis, accelerated Bcl-2, FLIP, GF, SCF, ET-1 cellular, senescence BAX, p53, caspase-3

  8. Slide 8: Vitiligo Treatments

    Vitiligo Treatments – For personal use only Categories Clinical status CUV’s views A Non-pharmaceutical I narrowband UVB (308nm) standard of care, 12–18 m, 200 mJ/cm² remains adjuvant for GV >10%, non-face BSA II PUVA experimental, 0.6 mg/kg + 2 J/cm² less used III XTRAC LASER (308nm) in practice, 1

  9. Slide 9: CLINUVEL's Innovation

    CLINUVEL’s Innovation Biomimicry as a therapeutic approach For personal use only CUV102 (2012-2013) n=58 Afa 16mg + NB-UVB • FST Type III vs IV-VI 20 vs 35 • FST IV-VI: VASI day 56 + 84 p<0.05 • D-spreading: day 56 p<0.001 • Time-to-onset: face p=0.0001 • Extremities p=0.003 ¹non-parametric testing

  10. Slide 10: CLINUVEL – Afamelanotide repigmentation vs Ruxolitinib

    CLINUVEL – For personal use only Afamelanotide repigmentation Ruxilitinib FDA approved 2022 • systemic treatment, 16 mg • 1.5% cream (topical, BID) • generalised vitiligo, adults • children >12 yr • type IV-V-VI (darker skin) • Ph II (n=157): double-blind randomized • head & neck • 24 weeks study, c

  11. Slide 11: CLINUVEL's Regulatory Pathway

    CLINUVEL’s Regulatory Pathway For personal use only CUV102 +NB-UVB n=56 CUV103 +NB-UVB n=21 A B 2022: >12,000 doses FDA accepts CUV104 CUV105 safety profile afamelanotide monotherapy n=6 +NB-UVB n=85 Nov ’22 NB-UVB combination CUV106 CUV107 • 2012 – 2022 FDA-CUV misaligned 14 months monotherapy n=85

  12. Slide 12: Vitiligo Main clinical research – Oct 2022

    Vitiligo For personal use only Main clinical research – Oct 2022 1. BMS: NB-UVB + apremilast 30 mg p/o Ph II, n=23 2. Pfizer: crisaborole (PDE4i) + NB-UVB 2% topical Ph II, n=64 3. U Bordeaux: baricitinib + NB-UVB 4mg/d p/o Ph II, n=48 4. U Sth Car: rapamycin 01%-0.001% topical Ph II, n=20 5. Villar

  13. Slide 13: Afamelanotide Addressable Vitiligo Market

    Afamelanotide Addressable Vitiligo Market For personal use only Global market 2027 $4.5B* Incidence Eligible 0.5% BSA Seeking Tx Penetration 0.2% H/N Yr 1-2 Market 1% 25% 40% 40% 9% $490-570M* 3,295,000 823,750 329,500 65,900 5,931 total vitiligo 7–8 doses afamelanotide > 90% population repigmentati

  14. Slide 14: Summary

    Summary For personal use only Pharmaceuticals 1 Xeroderma pigmentosum – assisted DNA repair (3 trials ongoing) CATALYSTS 2022-2023 2 Vitiligo - afamelanotide monotherapy + combination therapy (2 trials) XP/DNA repair read out Ph II 3 Stroke – reduction in penumbra, NIHSS (1 trial) Start Ph II trial

  15. Slide 15: Investor Enquiries

    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 www.clinuvel.com Level 11, 535 Bourke Street Melbourne

Clinuvel Pharmaceuticals — Investor Presentation (October 2022) on 6ix