Financial Performance

Since start of commercial distribution in June 2016, CLINUVEL has reached annual profitability and positive net cash flows. The Company is self-sufficient, distributing its lead product SCENESSE® in the US and EU for a genetic disorder porphyria (EPP). The Company has paid annual dividends since 2018.

Five year Revenue and NPBT CAGR, 31.3% and 37.0%, respectively. NPAT (of A$11.4 million) for the six months to 31 December 2022 was the highest for a December half year, and the 14th consecutive half year profit. The balance sheet is strong and growing; debt-free and cash reserves of A$141 million, exceeding four times FY2022 expenses. This position enables management to manage the challenging operational environment, and self-finance organic expansion. No dilutive capital raisings since March 2016.

Management Team

Total 70 employees, an executive management team of 9 (median tenure of 15 years). Gender diversity throughout Board and firm.

In-house functions: R&D, regulatory, clinical, market access, distribution, pharmacovigilance, communications, branding and marketing, and finance.

Graph: Finances

Overcoming two decades of challenges the firm has pioneered;
its current success is best characterized by:

“Resourcefulness – Longitude – Pre-emption”

Vision

Translating melanocortins to commercial products benefiting unmet need.

Differentiated

Establishing a fully integrated house – a pharma division & specialized consumer care; manufacturing; communications, branding & marketing.

Key Data

Main Exchange, ASX CUV
Shares on issue 49,410,338
Average Daily Trading (last 65 days) 88,259
52–week High A$28.72
52–week Low A$13.16
Market Capitalisation A$1.0 Bn
Price Earnings Ratio 47.6
Price to Book Ratio 7.9
EV/Revenue 13.1
EV/EBITDA 25.8

Shareholding

Board and Employees 11.2%
- CEO 6.3%
- Chairman 3.5%
American Depositary Receipts 8.7%
Ender 15.2%
Top 20 (beneficial) shareholders 60.0%
Ownership
- US 29%
- EU 38%
- AU 32%

Analyst Coverage, Target Prices Feb ’23

Jefferies Australia A$38.60
Wilsons Advisory A$30.70
Moelis Australia A$23.21

Evolution of Strategy

Phase I: 2006-2020 Development & Commercialisation

Lead melanocortin, SCENESSE® (afamelanotide 16mg)

  • erythropoietic protoporphyria (EPP), rare metabolic disorder causing anaphylactoid reactions to light exposure
  • regulatory approvals – EMA ‘14, FDA ‘19, TGA ‘20, Israel ‘20
  • commercial distribution – EU ‘16, USA ‘20, Israel ‘21
  • vitiligo Phase II (2)

Phase II: 2021-2022 Diversification Pipeline

  • expansion melanocortin portfolio:
    • PRÉNUMBRA® INSTANT – afamelanotide liquid
    • NEURACTHEL® INSTANT – ACTH liquid
  • Phase IIb
    • xeroderma pigmentosum (XP), DNA skin repair
  • Ph IIb
    • vitiligo (VO)
  • Ph IIa
    • arterial ischaemic stroke (AIS)
  • Healthcare
    • products for photoprotective skin care

Phase III: 2023-2025 Expansion

  • Ph III
    • XP, submission marketing authorization
    • EMA–FDA
  • Ph III
    • VO, submission MA
  • Ph IIb
    • AIS, improving cerebral blood flow
  • Launch
    • innovative skin care product lines (4),
    • polychromatic photoprotection (2),
    • DNA repair and melanogenesis
  • Manufacturing
    • multiple formulations at GMP scale
  • Acquisition
    • manufacturing, rare vascular/endocrine disorders, skin cancers, dermato-cosmetic

For more information visit:
www.clinuvel.com

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