Clinuvel Pharmaceuticals Limited · ASX:CUV

Clinuvel Pharmaceuticals — Investor Presentation (June 2023)

23 slides from Clinuvel Pharmaceuticals's investor presentation, Jun 29, 2023

  1. Slide 1: ASX Announcement: Twilight Event - Briefing

    ASX ANNOUNCEMENT Twilight Event - Briefing ASX: CUV Melbourne, Australia, 29 June 2023 Börse Frankfurt: UR9 ADR Level 1: CLVLY For personal use only CLINUVEL presented during a Twilight Briefing, after the close of market yesterday. Organised by Monsoon Communication, a slide deck of the Twilight Br

  2. Slide 2: For personal use only

    made, and the Company undertakes no obligation, outside of those required under applicable laws or relevant listing rules of the Australian Securities Exchange, to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. More information on

  3. Slide 3: Unfolding - Twilight Briefing Melbourne

    For personal use only Unfolding 28 June 2023 Twilight Briefing Melbourne Hosted by Monsoon Communications

  4. Slide 4: Forward-looking statement

    Forward-looking statement This release contains forward-looking statements, which reflect the the outsourced manufacturing of SCENESSE®, CYACÊLLE®, For personal use only current beliefs and expectations of CLINUVEL’s management. PRÉNUMBRA® or NEURACTHEL® which may lead to it being Statements may inv

  5. Slide 5: Value

    For personal use only Value

  6. Slide 6: Valuing bio-pharmaceuticals

    Valuing bio-pharmaceuticals P/E ratios bio-pharmaceuticals 48 US/AU, 2 EU 50 bio-pharmaceutical (48 US/AU, 2 EU) For personal use only 100 TIC P/E TIC P/E TIC P/E NVO 40.2 INCY 41 RYTM - 80 AZN 48 BMRN 97 ANIP - PFE 7.1 SRPT - CUV 41 60 NVS 30 REC 28 MNK - CSL 44.3 JAZZ - PTN - SNY 15 ROIV - 40 REGN

  7. Slide 7: CLINUVEL valuation

    CLINUVEL valuation For personal use only Differentiation US fund: Date/period Activity P/E Share Price ”We don’t usually meet profitable pharmaceutical 22 Sep 2014 EMA appr - 4.90 companies, great story…” 09 Oct 2019 FDA appr 120 45.00 US Inst. shareholder: 16 Mar 2020 US distrib 36 13.62 “…only thr

  8. Slide 8: Pipeline

    For personal use only Pipeline

  9. Slide 9: Clinical pipeline skin-brain

    Clinical pipeline skin-brain For personal use only MELANOCORTINS: 8 programs – 4 photomedicine + 4 central nervous system 4 Rx products – TAM > $2B Products Indication Age group Phase I Phase II Phase III Commercial SCENESSE® EPP¹ adults EEA-US 1 SCENESSE® EPP¹ adolescents regulatory interaction, up

  10. Slide 10: Clinical programs afamelanotide

    Clinical programs afamelanotide Erythropoietic Protoporphyria (EPP) Xeroderma Pigmentosum (XP) For personal use only Genetic disorder Genetic disorder Absolute light intolerance, phototoxicity Highest risk of photodamage, Sk/Can Expansion SCENESSE® – adolescents 12–17 yrs 4 trials: 25 patients - ong

  11. Slide 11: Finance

    For personal use only Finance

  12. Slide 12: Financial performance 2005 – 2023

    Financial performance 2005 – 2023 70 Total Revenue $m Expenses $m NPBT $m For personal use only 50 30 10 -10 2016 2017 2018 2019 2020 2021 2022 Year ended 30 June Discipline 2005 – 2023 Financing debt-free Equity minimal dilution < 300% FYE 23 RESULTS: Liquidity ratio retaining min. cash: 2 years of

  13. Slide 13: Financing

    Financing For personal use only 2021-2025 A$175M I PHARMACEUTICALS SCENESSE® - expanded use in XP, vitiligo, VP 31 Dec 2022 A$72M expensed (41%) PRÉNUMBRA® - 2nd gen. afamelanotide AIS 31 Dec 2022 cash reserves A$140.7M NEURACTHEL® - ACTH CNS disorders Cash reserves (31 Dec) A$m II PHOTOCOSMETICS 15

  14. Slide 14: Photocosmetics

    For personal use only Photocosmetics

  15. Slide 15: From photomedicine to photocosmetics?

    From photomedicine to photocosmetics? For personal use only MELANOCORTINS IN PHOTOMEDICINE COUNTERFEITS 1. safety/stability/efficacy Origin mass demand for melanogenesis 2. anti-oxidative − history MELANOTAN-EPITAN 1980–2005 3. vasoactive − ± $50m counterfeit self-injectable tanning 4. DNA repair pr

  16. Slide 16: From photomedicine to photocosmetics?

    From photomedicine to photocosmetics? For personal use only ACTH +/- 43 y data – photomedicine AFAMELANOTIDE Transdermal, leave-on product lines 1. CYACÊLLE polychromatic range PARVYS/PHI-MELANOTIDE “photocosmetics” 2. DNA assisted repair 3. melanogenic (sun-free bronzing products) MARKETING = GLOBA

  17. Slide 17: Transformational program

    Transformational program Science - evidence based Strategy melanocortins In-house CBM Pharmaceuticals For personal use only trust-longevity in photocosmetics division +/- 25 1. Strategic marketing - Direct branding 2. Branding, partnership 1 Social media - Performance marketing management - User-gen

  18. Slide 18: Conclusion

    Conclusion For personal use only 1. Financial strength – discipline enables CAGR 30%, cash reserves to execute 2. Core pharmaceutical business – transformation to 8 programs, 4 Rx products CNS, 4 photomedicine CLINICAL 3. Photocosmetics complementing pharma – 3 product lines: 1. polychromatic, 2. DN

  19. Slide 19: Thank you for your interest

    For personal use only Thank you for your interest Appreciation to Monsoon 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 Media Enquiries Mr Rud

  20. Slide 20: Questions received and addressed

    For personal use only Questions received and addressed Competition in orphan diseases and SCENESSE® Segmentation vitiligo: how does SCENESSE® fit into future treatment? Catalysts for 2023

  21. Slide 21: How to view competition in orphan diseases?

    How to view competition in orphan diseases? Where is SCENESSE® on pareto curve? For personal use only Example: market for hereditary angioedema (HAE; prevalence: 1:10-50k) Product Therap. approach FDA appr. Sponsor US$ “per HAE attack”¹⁻⁴ CINRYZE reconst. h-plasma Oct 2008 Lev Pharma. (acq by ViroPh

  22. Slide 22: Presented at AAD 2023 - Vitiligo Future Treatment

    Presented at AAD 2023 - Vitiligo Future Treatment Global Vitiligo Foundation Afamelanotide 1. non-immune suppressant For personal use only 2. physiological response Future 3. activates eumelanin treatment of vitiligo 4. icw NB-UVB differentiates stem cells 5. stabilizes eumelanin 6. < 4 weeks to 1st

  23. Slide 23: Catalysts 2023

    Catalysts 2023 SCENESSE® use in adolescents EMA outcome For personal use only Vitiligo CUV105, n=150, TVASI50 start XP CUV151-156 read outs VP CUV040 1st results AIS CUV803 1st results NEURACTHEL® manufacturing Photocosmetics launch, e-commerce global launch event FYE23 financial performance 21

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