Hyphens Pharma International Limited announced that its subsidiary, Hyphens Pharma Pte. Ltd., has entered into exclusive license and supply agreements with Cassiopea S.p.A., a subsidiary of Cosmo Pharmaceuticals N.V. (Cosmo) for the exclusive rights to develop and commercialize Winlevi® (clascoterone) cream 1% and all future product extension and/or improvement in the treatment of acne in 10 countries across Southeast Asia. Winlevi® is a U.S. Food & Drug Administration (FDA) approved novel drug with a unique mechanism of action for the topical treatment of acne in patients aged 12 years and older.

It is the topical androgen receptor inhibitor that tackles the androgen hormone component of acne and is the first new type of acne medication approved by the FDA since 1982. As the only topical cream to treat hormonal acne directly in the skin, it offers a non- antibiotic approach for acne-sufferers everywhere. Winlevi® inhibits sebum production and inflammation by targeting the androgen receptors in the sebaceous gland cells.

Oral treatments are typically prescribed to address hormonal acne, but usually only prescribed to females. With Winlevi®, males suffering from acne, as well as females who don't want to take oral medications, can now benefit from this first-in-class treatment, making Winlevi® a game-changer in the fight against acne. In a study involving 3,888 Singapore Chinese subjects, the estimated prevalence of acne vulgaris is 53.8%.

Acne can have profound social and psychological effects on adolescents or young adults when it affects their self-esteem. As the first novel acne drug in decades, Winlevi® has huge potential to revolutionize the acne treatment space. Winlevi® will be Hyphens Pharma's first innovative therapeutics, deepening its dermatology pipeline.

Pursuant to the exclusive license and supply agreements, the Group will pay Cassiopea S.p.A., an upfront payment of USD 1 million, potential regulatory and sales milestones totalling up to USD 4 million and customary double-digit royalties on net sales. The exclusive license and supply agreements will not have a material effect on the net tangible assets or earnings per share of the Group for the financial years ending 31 December 2022 and 31 December 2023.