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|Melbourne, Australia, 12 May 2022||ASX:
ADR Level 1:
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.
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:
CLINUVEL’s core business, focused on developing and delivering drugs for patients with unmet medical need.
developing non-prescription products derived from the knowhow and active ingredients used in the Pharmaceuticals Division.
prepares communications to wider differentiated audiences, positioning the Group for broader engagement.
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.
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.
|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|
|CUV9900||adults||topical, leave on||in development||anti-oxidative, DNA repair|
|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|
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|
|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|
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.
Level 11, 535 Bourke St Melbourne, 300 Vic, Australia
+61 3 9660 4900
+61 3 9660 4909