CASSIOPEA S.P.A.
EQS Group-Ad-hoc: Cassiopea S.p.A. / Key word(s): Half Year Results
Cassiopea Announces Results for First Half of 2021
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.
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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.
Key Highlights
. During the first half of 2021, activities were focused on the preparations for the US commercial launch of Winlevi
(R) (clascoterone cream 1 %) and advancing the development of clascoterone solution for androgenetic alopecia
(AGA).
. Multiple transaction structures and opportunities were evaluated over the last twelve months in order to optimize
the US commercial launch of Winlevi(R).
. Post period, on July 26, Cassiopea and Sun Pharmaceuticals Industries Ltd. announced the signing of License and
Supply Agreements for Winlevi(R) (clascoterone cream 1%) in the US and Canada. Under terms of the agreements, Sun
Pharma will commercialize Winlevi(R) in the US and Canada and Cassiopea will be the exclusive supplier of the
product. Cassiopea will receive an upfront payment of US USD45 million, potential commercial milestones totalling up
to US USD190 million and customary double digit royalties. The agreements will close upon the expiration of HSR
waiting period. Winlevi(R) is expected to be available in the US in Q4 2021.
. The Phase II trial investigating clascoterone solution for the treatment of androgenetic alopecia (AGA) in females
was completed in the reporting period. Top line results will be available in 3Q 2021.
. Progress was made in the development of a new Patient Reported Outcome (PRO) Questionnaire for AGA which has been
requested by the FDA to be used in the future Phase III trials of clascoterone solution for AGA in males.
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
In EUR thousands H1 2021 H1 2020
(with the exception of the share data in EUR)
Revenue - -
Cost of sales - -
Research and development expenses (3,753) (2,510)
Selling, general and administrative expenses (2,535) (2,180)
Net operating expenses (6,288) (4,690)
Operating result (6,288) (4,690)
Profit (Loss) before taxes (6,165) (5,322)
Profit (Loss) after taxes for the period (6,165) (5,322)
Profit (Loss) per share -0.573 -0.53
In EUR thousands 30.06.2021 31.12.2020
Non-current assets 12,498 12,797
Inventories 1,817 761
Other current assets 2,291 2,423
Cash and cash equivalents 1,796 2,646
Total assets 18,402 18,627
Non-current liabilities - 66
Current Liabilities 8,557 2,946
Total Equity 9,845 15,615
Total Equity & Liabilities 18,402 18,627 Financial Results for the Half Year Ended June 30, 2021 . No revenues and consequently no cost of sales were generated in H1 2021 since no products were on the market. . R&D costs increased mainly due to Phase II trials of Clascoterone solution for androgenetic alopecia in females. . SG&A in line with the same period of the previous year. . Loss for the period increase from EUR 5,322 thousand to EUR 6,165 thousand. . Non-current assets, which include intangible and the R&D credit, stable at EUR 12,498 thousand. . Inventories, EUR 1,817 thousand, refer to the API (Active Principle Ingredient) stock required for the production
for the commercial launch of Winlevi(R). . Current liabilities include EUR 6,226 thousand related to the draw down from the Cosmo Pharmaceuticals N.V.
unsecured credit facility (EUR 6,000 thousand) and interest, that will be reimbursed in the course of the following
months. . Total equity decreased from EUR 15,615 thousand to EUR 9,845 thousand mainly because of the loss for the period. Half Year 2021 results conference call at 16:00 CEST on July 29, 2021 Diana Harbort, CEO; Luigi Moro, CSO; Alessandro Mazzetti, CMO; Pierpaolo Guzzo, CFO; and Marco Lecchi, Finance Director, will host a conference call to discuss the half year 2021 financial results to be held today at 16:00 CEST. Dial-in numbers:
Switzerland / Europe: +41 (0) 58 310 50 00 From UK: +44 (0) 207 107 06 13 From USA: +1 (1) 631 570 56 13 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: https://www.cassiopea.com/wp-content/uploads/2021/07/Cassiopea_Half_Year_Report_2021.pdf and https://www.cassiopea.com/wp-content/uploads/2021/07/Cassiopea_Half_Year_2021-Financial-Results_Presentation.pdf
Next events
Credit Suisse Equity Conference November 16-19, 2021, Zurich Jefferies Global Health Care Conference November 16-18, 2021, London
About Winlevi
Indication
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
CONTRAINDICATIONS: None.
WARNINGS Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. If these effects occur, discontinue or reduce the frequency of application of WINLEVI cream.
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.
ADVERSE REACTIONS Most common adverse reactions occurring in 7 to 12% of patients are erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and burning occurred in >3% of patients and were reported in a similar percentage of subjects treated with vehicle.
About Cassiopea
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.
Contact Cassiopea SpA Diana Harbort, CEO & Head of Investor Relations Tel: +39 02 868 911 24, dharbort@cassiopea.com
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