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Clinuvel Pharmaceuticals Ltd: Segment Analysis

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Business Description

Clinuvel Pharmaceuticals Ltd (Clinuvel Pharmaceuticals) is a bio-pharmaceutical company that carries out the development of photo protective drugs as a preventive treatment for light related skin disorders. Clinuvel’s lead compound Scenesse (afamelanotide), is a first-in-class drug candidate which is photo protective drug against damage to the skin by UV radiation and sunlight. It increases the melanin level in the skin and acts as a shield against subsequent prolonged UV radiation (UVR). Scenesse is delivered by a subcutaneous dissolving implant which is approximately of 16mg. Scenesse is approved in the US, Australia and Europe for the treatment of adult erythropoietic protoporphyria (EPP) patients. Scenesse is in Phase II trials for the treatment of adult vitiligo patients globally and in Phase II for the treatment of adult variegate porphyria patients (Europe), xeroderma pigmentosum patients and arterial ischaemic stroke patients. Other preclinical pipeline candidates include CUV9900 and VLRX001, which are melanocortin analogues evaluated for adjuvant maintenance therapy in vitiligo, with the aim to develop both medicinal and non-prescriptive formulations to be administered topically. The company is also focused on developing a pediatric formulation of Scenesse for EPP; OTC products for general photoprotective application. The company is also manufacturing Prenumbra in its facility in Singapore. The company has operations in the US, Switzerland, Singapore, UK and Australia. The company operates through subsidiaries. The company generates revenue from the commercial sales of Scenesse in Europe and the US. Reimbursement revenue of the product was also earned within Europe, and Switzerland. The company operates in two reportable geographic segments based on revenue generated by selling products to external customers: European Economic Area and USA and Switzerland, Others.

R&D Overview

The company’s research and development (R&D) focuses on developing treatments for genetic, metabolic, and life-threatening disorders, as well as healthcare solutions for the general population and commercializing its lead drug candidate SCENESSE. The company invested AUD0.5 million in R&D activities in FY2021 which grew 60.7% YoY.




Geographical Segments

Performance

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Performance

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