Mithra is a clinical-stage company with a pipeline focused on novel native estrogen estetrol (E4)-based products and complex therapeutics for women’s healthcare. • Mithra is coming to a turning point with results coming up in 3Q18 on a phase III trial in Europe/Russia for the combined oral contraceptive Estelle. Results for the US/Canada trial are anticipated for 1Q19. Next step is the regulatory approval and commercialization of the drug for which the company intends to attract a strategic partner. • Positive phase IIb data on a second drug, Donesta, for women suffering from menopausal complications (or hot flushes), were communicated in 2Q18. Mithra indicated that it intends to continue with this pipeline drug via a co-development scenario. As such, a strategic partner with commercial footprint can reduce the development and commercialization risk and bring out the maximal sales potential of the drug. • In 2018, we will as well see upside in a third program, MyRing. This is a complex generic for Merck’s vaginal ring, NuvaRing, that went off patent in Apr 2018. Commercial launch in Europe is foreseen for 2Q18 and 1Q19 in the US through a local partner, Mayne pharma. • In anticipation of the Estelle phIII results and the announcement(s) on partnerships for Estelle and/or Donesta (co-development), we updated our investment case. Estelle and Donesta now each take up € 10/share. MyRing accounts for € 4.0/share and we as well revised the potential of the CDMO facility for which multiple contracts already have been signed. Following our SOTP/DCF analysis, we increase the Target Price to € 35.0/share (from € 27/share) with Buy rating maintained.
Mithra Pharmaceuticals SA is a Belgium-based company active in the pharmaceutical industry. The Company is dedicated to provide products and services for the fertility, contraception and menopause of women. It has a number of patent families regarding Estetrol (E4), a natural estrogen produced by the human foetus, which enables the investigation of fertility and contraception products. Mithra is focused on the development of two late-stage E4-based products: Estelle, a 5th generation oral contraceptive, and Donesta, a hormone therapy for Vasomotor Symptoms in menopause. Mithra develops a contraceptive vaginal ring called Myring and Zoreline, a biodegradable subcutaneous implant for hormone dependant cancer.
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