March 7 (Reuters) - Mithra Pharmaceuticals SA
MITRA.BR :
* FY REVENUES INCREASED STEADILY TO REACH EUR 67 MILLION,
MAINLY
DRIVEN BY THE SIGNATURE OF THE FIRST LICENSE AGREEMENT FOR
DONESTA® WITH GEDEON RICHTER
* CASH POSITION AT EUR 28.3 MILLION END 2022
* 2022 EBITDA STANDS AT EUR -14.3 MILLION COMPARED TO EUR
-77.5
MILLION IN 2021
* ESTELLE® FURTHER COMMERCIAL LAUNCH IN EUROPE, LATIN
AMERICA AND
ASIA, AS WELL AS ADDITIONAL MARKETING AUTHORIZATIONS IN BRAZIL,
ISRAEL, PERU & SERBIA EXPECTED IN 2023
* LAUNCH OF POST APPROVAL SAFETY STUDY (PASS) EARLY Q2 2023
FOR
EUROPE (EMA). PROTOCOL FOR THE U.S. SENT EARLY 2023
* 2022 LOSS BEFORE TAXES IMPROVES THANKS TO THE POSITIVE
IMPACT OF
EUR 28.3 MILLION BOOKED IN THE CHANGE IN FAIR VALUE OF THE
CONTINGENT CONSIDERATION PAYABLE RELATED TO ESTELLE®
* LICENSE AND SUPPLY AGREEMENT FOR DONESTA® IN THE U.S. AND
CANADA
EXPECTED IN H1 2023. OTHER COUNTRIES ARE ALSO BEING
ADDRESSED/UNDER NEGOTIATIONS
* FILING DONESTA® BY THE FDA IN THE U.S. EXPECTED TO BE
SUBMITTED
BY THE END OF H1 2023
* FULL DATA SET TO MAKE DECISION ON ACQUISITION OF THE IP
FROM BCI
PHARMA WILL BE AVAILABLE IN Q2 2023
* LAUNCH OF 3 PHASE II STUDIES IN DONESTA® CLINICAL PROGRAM
CARRIED OUT ON SKIN HEALTH, HAIR QUALITY AND FEMALE SEXUAL
AROUSAL DISORDER (FSAD), WHICH CLINICAL SAFETY RESULTS (CSR) ARE
EXPECTED IN Q4 2024 FOR SKIN HEALTH AND HAIR QUALITY STUDY
Source text: [ID: https://bit.ly/3muoR34]
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