Building a diversified
Specialty Pharmaceutical Company

Melbourne, Australia, 12 May 2022 ASX:
XETRA-DAX:
ADR Level 1:		 CUV
UR9
CLVLY

Introduction

CLINUVEL PHARMACEUTICALS LTD is a global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders, as well as healthcare solutions for the general population. As pioneers in photomedicine, with a focus on melanocortin peptides, CLINUVEL’s research and development is leading to innovative treatments for patient populations with a clinical need for systemic photoprotection, DNA repair, repigmentation and acute or life-threatening conditions lacking therapeutic alternatives.

CLINUVEL’s first molecule, afamelanotide, is a potent, fortified analogue of the alpha-melanocyte stimulating hormone. The formulation, SCENESSE® (afamelanotide 16mg) is approved for commercial distribution in Europe, the USA, Israel and Australia as the world’s first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). EPP is a genetic metabolic disorder, characterised as absolute light intolerance, with a worldwide prevalence of 1:140,000.

Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore, and the USA.

Business Operations

CLINUVEL operates an integrated business model, disintermediating most services, establishing and retaining all functions ‘in-house’, e.g., R&D, the clinical program, regulatory liaison, self-distribution, market access and reimbursement and corporate finance. With a relatively compact team of specialised professionals worldwide, the Company has an unusually high employee retention rate and tenure of managers exceeding ten years.

To achieve its objectives, the Group is organised across four divisions:

Pharmaceuticals

CLINUVEL’s core business, focused on developing and delivering drugs for patients with unmet medical need.

Healthcare Solutions

developing non-prescription products derived from the knowhow and active ingredients used in the Pharmaceuticals Division.

Communications, Branding & Marketing

prepares communications to wider differentiated audiences, positioning the Group for broader engagement.

Manufacturing

to manufacture novel formulations and products for CLINUVEL and research, development and production for other companies and research groups in the biopharmaceutical sector.

Underlying the divisional structure is the Research Development & Innovation (RDI) Centre in Singapore, researching molecular science, biology, and follow-on formulations.

Expansion of the Melanocortin Drug Portfolio and Clinical Program

Through the Pharmaceuticals Division, CLINUVEL’s organic expansion utilises expertise of the pharmacology of melanocortins to develop a portfolio of prescription products, targeting identified patient populations who lack therapeutic alternatives.

Specialty Pharmaceutical
Portfolio of melanocortins

1. Afamelanotide
SCENESSE® adults solid in production EPP, XP, vitiligo
SCENESSE® Enfance paediatric 12-17 liquid in development EPP, XP, vitiligo
PRÉNUMBRA® Instant all ages liquid in production stroke, XP
PRÉNUMBRA® Modified-release adults liquid in development stroke
2. CUV9900
CUV9900 adults topical, leave on in development anti-oxidative, DNA repair
3. ACTH
NEURACTHEL® Instant adults liquid in production acute neurological, endocrinological and degenerative disorders
NEURACTHEL® Modified-release adults liquid awaiting production acute neurological, endocrinological and degenerative disorders

Clinical Development

Shielding patient with Xeroderma Pigmentosum

DNA Repair
CUV156 (n=6)
CUV151/152/153

  • Xeroderma Pigmentosum patients at highest risk of exposure to UV-HEV
  • Disease-free individuals as control (CUV151)
  • Endpoints: safety, anti-oxidative effect DNA repair
vitiligo-back

Vitiligo
CUV104

  • Patients of darker skin types (Fitzpatrick IV-VI)
  • Inclusion > 10% depigmentation 
  • Endpoints: face, head & neck
  • >70% repigmentation
  • COV104 pending
variegate-porphyria-close-up

Variegate Porphyria
CUV040

  • Confirmed biochemical diagnosis
  • Inclusion: multiple lesions p/a
  • Endpoints: reduction in blister formation
  • Controlled photo-provocation  
ais-pca-m1–m4_crop

Arterial Ischaemic Stroke
CUV801 (n=6)

  • First study completed
  • Final results confirmed safety with no cerebral adverse events and neurological functions in 5 patients
  • Next steps to be advised
map-of-globe

New Indication
CUV901

  • Awaiting Administrative sign-off, IP

Financial Performance

Reflecting effective strategy implementation with conservative financial management, CLINUVEL achieved cash positivity and profitability in the first full year of commercial operations (FY2017, ending 30 June). The Company crowned five years of commercial operations by delivering record revenues and profit in FY2021 and declared a fourth consecutive annual dividend.

Five Year Summary FY2021 FY2020 FY2019 FY2018 FY2017
Total Revenues, A$m 48.5 33.9 32.5 26.2 17.2
Net Profit after income tax expense, A$m 24.7 15.1 18.1 13.2 7.1
Total Assets, A$m 108.6 81.5 62.3 42.9 28.6
- Cash Reserves, A$m 82.7 66.7 54.3 36.2 23.8
Equity, A$m 98.7 72.1 57.2 39.4 25.4
Net increase in cash held, A$m 16.9 11.8 17.2 11.6 9.9
Basic earnings per share, A$ 0.50 0.31 0.38 0.28 0.15
Net tangible assets backing per share, A$ 1.9 1.4 1.2 0.8 0.5
Return on Equity, % 25.0 21.0 32.0 34.0 28.0
Dividends, A$ cents 2.5 2.5 2.5 2.0 Nil

Summary

CLINUVEL is a rare success story in the Asia-Pacific life sciences sector, having developed a drug portfolio from the laboratory to achieve viable commercial operations based on a self-distribution model, to provide positive returns to shareholders. CLINUVEL’s share price rose by 591% over the five years to 30 June 2021. The Company is undertaking a growth and expansion path from a position of financial strength to develop a diversified and sustainable specialty pharmaceutical company offering a compelling proposition to potential long-term and committed investors.

ASX:CUV

Closing Price, A$

Forward-looking Statements

This release contains forward-looking statements, which reflect the current beliefs and intentions of CLINUVEL’s management. Statements may involve a number of known and unknown risks that could cause our future results, performance, achievements or output to differ significantly from those expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialise pharmaceutical products; the COVID-19 pandemic and/or other world, regional or national events affecting the supply chain for a protracted period of time, including our ability to develop, manufacture, market and sell biopharmaceutical products; competition for our products, especially SCENESSE® (afamelanotide 16mg), PRÉNUMBRA® or NEURACTHEL®; our ability to achieve expected safety and efficacy results in a timely manner through our innovative R&D efforts; the effectiveness of our patents, trademark and other protections for innovative products, particularly in view of national and regional variations in patent laws; our potential exposure to product liability claims to the extent not covered by insurance; increased government scrutiny in either Australia, the U.S., Europe, Israel, China and Japan of our agreements with third parties and suppliers; our exposure to currency fluctuations and restrictions as well as credit risks; the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE®, PRÉNUMBRA® or NEURACTHEL® which may lead to it being unable to supply its commercial markets and/or clinical trial programs; any failures to comply with any government payment system (i.e. Medicare) reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology and consumer based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; our ability to retain or attract key personnel and managerial talent; the impact of broader change within the pharmaceutical industry and related industries; potential changes to tax liabilities or legislation; environmental risks; risks originating from equity markets, and other factors that have been discussed in our 2021 Annual Report. Forward-looking statements speak only as of the date on which they are 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 material information, future events or otherwise. More information on preliminary and uncertain forecasts and estimates is available on request, whereby it is stated that past performance is not an indicator of future performance.

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Contact

www.clinuvel.com

Level 11, 535 Bourke St Melbourne, 300 Vic, Australia

+61 3 9660 4900
+61 3 9660 4909