Brief: Mithra FY Net Loss Widens To 116.9 Million Euros, Evaluates Risks For Estelle Launch In Russia Expected For H2 2022

Mithra Pharmaceuticals SA

08/03/2022 06:46

March 8 (Reuters) - Mithra Pharmaceuticals SA  MITRA.BR :
    * LANDMARK YEAR WITH WORLDWIDE LAUNCH OF FIRST
ESTETROL-BASED
PRODUCT ESTELLE®, LEADING TO A CASH COLLECTION OF TWO MAJOR
OUT-LICENSING MILESTONES FOR AN AMOUNT OF EUR 24 MILLION AND
PRODUCT SALES OF EUR 13.4 MILLION.
    * STILL AROUND EUR 290 MILLION CASH TO BE COLLECTED FOR
ESTELLE
OUT-LICENSING AND SALES RELATED MILESTONES.
    * CASH POSITION AT EUR 32.9 MILLION END 2021, STRENGTHENED
BY
POST-YEAR END FLEXIBLE EQUITY FINANCING AGREEMENT CONTRACTED
WITH GOLDMAN SACHS INTERNATIONAL FOR EUR 100 MILLION
    * POSITIVE TOP-LINE RESULTS FROM DONESTA PHASE 3 STUDIES,
ALLOWING
TO MOVE FORWARD EXTENDED CLINICAL PROGRAM AND TO FURTHER BROADEN
SCOPE OF DONESTA AS A GLOBAL ALTERNATIVE FOR MILLIONS OF
MENOPAUSAL WOMEN
    * FY REVENUE EUR  22.7 MILLION VERSUS EUR 9.0 MILLION YEAR
AGO
    * FY LOSS FROM OPERATIONS EUR 87.9  MILLION VERSUS LOSS EUR
83.7
MILLION YEAR AGO
    * FY NET LOSS EUR  116.9 MILLION VERSUS LOSS EUR 92.1
MILLION YEAR
AGO
    * NEW MARKETING AUTHORIZATIONS IN EUROPE AND AUSTRALIA ARE
ANTICIPATED IN 2022, AS WELL AS ADDITIONAL REGULATORY
SUBMISSIONS IN LATIN AMERICA
    * DONESTA PRIMARY SAFETY RESULTS ANTICIPATED FOR END 2022 IN
THE
UNITED STATES/CANADA AND FOR END H1 2023 IN EUROPE
    * MITHRA BELIEVES IT COULD ACHIEVE MARKETING AUTHORIZATION
FOR
DONESTA IN H1 2024 FOR THE UNITED STATES AND IN H2 2024 FOR
EUROPE
    * MONITORING OF THE GEOPOLITICAL SITUATION IN EASTERN EUROPE
AND
RISK ASSESSMENT ON MITHRA’S AND PARTNERS ACTIVITIES, IN
PARTICULAR ESTELLE LAUNCH IN RUSSIA FORESEEN IN H2 2022
    * EXPECTED MILESTONES FOR 2022: LAUNCH OF 3 ADDITIONAL
STUDIES IN
DONESTA CLINICAL PROGRAM (VULVOVAGINAL ATROPHY, SKIN AND HAIR
QUALITY) IN 2022, DEPENDING ON REGULATORY AGENCY FEEDBACK
    * LICENSE AND SUPPLY AGREEMENT FOR DONESTA FOR GLOBAL
COMMERCIAL
LAUNCH ANTICIPATED IN 2024
    * GEOPOLITICAL SITUATION IN EASTERN EUROPE: ON THE RESEARCH
AND
DEVELOPMENT SIDE, WE ARE CURRENTLY ANALYZING THE SITUATION
REGARDING THE POTENTIAL IMPACT ON THE RECRUITMENT FOR THE
ADDITIONAL EUROPEAN DONESTA STUDY (C301) THAT SHOULD BE
COMPLETED BY THE END OF H1 2022
    * IF NEEDED, WE WILL ACTIVE A MITIGATION PLAN IN ORDER TO
SWITCH
THE PLANNED RUSSIAN RECRUITMENT SITES WITH OTHER SITES
    * ADDITIONAL COMMERCIAL LAUNCHES FOR VAGINAL CONTRACEPTIVE
RING
MYRING PLANNED DURING H2. FDA APPROVAL FOR COMMERCIALIZATION IN
U.S. BY MAYNE PHARMA, EXPECTED IN H2 2022
    * LAUNCH OF CLINICAL PROGRAM ON NEONATAL HYPOXIC-ISCHEMIC
ENCEPHALOPATHY (NHIE): STUDY IS EXPECTED TO BE INITIATED IN H1
2022, WITH RESULTS ANTICIPATED IN H2 2022

Source text for Eikon:  ID:nNDL5YMKg7 
Further company coverage:  MITRA.BR 

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