Cassiopea S.p.A. / Key word(s): Half Year Results
29-Jul-2021 / 07:00 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 LR
The issuer is solely responsible for the content of this announcement.
Ad hoc announcement pursuant to Art. 53 LR
Lainate, Italy – July 29, 2021 – Cassiopea SpA (SIX: SKIN), a specialty pharmaceutical company developing and preparing to commercialize prescription drugs with novel mechanisms of action (MOA) to address long-standing and essential dermatological conditions, today announced half-year results for the period ended 30 June 2021.
Diana Harbort, CEO of Cassiopea SpA, commented: ‘The highlight of the year to date was the announcement on July 26 of the signing of License and Supply Agreements for Winlevi(R) in the US and Canada with Sun Pharmaceutical Industries Ltd. We are very pleased to partner with Sun Pharma. Sun Pharma has a strong established US dermatology presence and will make Winlevi(R) widely available to dermatology health care providers and their patients. Following this transaction, Cassiopea will be expecting substantial revenue streams for the foreseeable future and will be well funded to continue the development of its innovative dermatology pipeline. Until the end of 2021, our priorities are supporting Sun Pharma in the successful launch of Winlevi(R) and the continuing the development of clascoterone solution for AGA, an area that has not seen innovation in 20-30 years. We estimate that Cassiopea will become profitable in 2021 with revenues in the range of EUR 37-39 million and operating profit in the range of EUR 24-28 million’.
Key financial figures
Financial Results for the Half Year Ended June 30, 2021
Half Year 2021 results conference call at 16:00 CEST on July 29, 2021
The Half-Year Report 2021 and the presentation with further information were published today, July 29, 2021, at 7:00 am CEST, and are available for download at:
Winlevi(R) (clascoterone cream 1%), is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. See www.WINLEVI.com for complete prescribing information and important safety information.
Important Safety Information
Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment with WINLEVI. In the PK trial, HPA axis suppression was observed in 1/20 (5%) of adult subjects and 2/22 (9%) of adolescent subjects at Day 14. All subjects returned to normal HPA axis function at follow-up 4 weeks after stopping treatment. Conditions which augment systemic absorption include use over large surface areas, prolonged use, and the use of occlusive dressings. Attempt to withdraw use if HPA axis suppression develops.
Pediatric patients may be more susceptible to systemic toxicity.
Hyperkalemia: Elevated potassium levels were observed in some subjects during the clinical trials. Shifts from normal to elevated potassium levels were observed in 5% of WINLEVI-treated subjects and 4% of vehicle-treated subjects.
Cassiopea is a specialty pharmaceutical company developing and commercializing prescription drugs with novel mechanisms of action (MOA) to address long-standing and essential dermatological conditions, particularly acne, androgenetic alopecia (or AGA) and genital warts. Cassiopea is investing in innovation that is driving scientific advancement in areas that have been largely ignored for decades. The portfolio comprises four unencumbered clinical candidates, for which Cassiopea owns the worldwide rights. The Company’s strategy is to leverage this expertise to optimize the commercial potential for its products directly or with a partner. For further information on Cassiopea, please visit www.cassiopea.com.
Some of the information contained in this press release may contain forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cassiopea has no obligation to publicly update or revise any forward-looking statements.
End of ad hoc announcement
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|Listed:||SIX Swiss Exchange|
|EQS News ID:||1222514|
|End of Announcement||EQS Group News Service|