- Revenues increased steadily to reach EUR 67 million, mainly driven by the signature of the first license agreement for Donesta® with Gedeon Richter
- Acceleration in the number of NEXTSTELLIS® cycles dispensed in the United States; launch in Australia by Mayne Pharma. Commercial roll out of DROVELIS® in all major European countries. In 2022, product sales on Estelle® stand at EUR 9.2 million
- Cash position at EUR 28.3 million end 2022, strengthened by post-closing events linked to the collection of an out-licensing upfront payment on Donesta® of EUR 50 million, the collection of the Mayne Pharma dividend for EUR 3 million and the milestone payment of EUR 1.6 million following Myring® commercialization in the U.S., which led to a cash position of EUR 67.5 million at end February 2023
- R&D expenses decreased by 25% to reach EUR 64.0 million compared to EUR 85.2 million in 2021
- Positive efficacy topline results from Donesta® Phase III Program
- Positive safety topline results from Donesta® Phase III Study in North America supporting the filing with U.S. regulatory agency anticipated by end of H1 2023 for a market authorization in H1 2024 whereas primary safety data are anticipated for H1 2024 in Europe with a market authorization expected for H1 2025
- FDA approval of Myring® commercialized under the trademark HALOETTE® in the U.S., leading to a milestone payment of EUR 6 million collected in H2 2022
- Convertible loan signed with Highbridge Capital Management and Whitebox Advisors for an amount up to EUR 100 million, including repurchase of EUR 34.1 million tranche of the convertible bonds due in 2025 at a 15% discount to par
Liege, Belgium, 07 March 2023 – 07:30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces its financial results for the year ended 31 December 2022, prepared in accordance with IFRS.
Leon Van Rompay, CEO Mithra Women’s Health, commented: “2022 marks a historical turning point for Mithra with the reception of the positive top-line efficacy results on our core asset Donesta® and the signature of a landmark license agreement with our long-standing partner Gedeon Richter. The positive top-line safety results announced early March 2023 are supporting the filing with U.S. regulatory agency anticipated by end of H1 2023 for a market authorization in H1 2024. Recent media attention on menopausal discomfort menopause around the globe demonstrates a clear shift towards Hormone Therapy. Building further upon our product lifecycle development plan, we remain confident to sign a future partnership for Donesta® in the US by the end of H1 2023. I am very pleased with our operational achievements in 2022 leading to revenues which increased steadily to reach EUR 67 million, the second highest level of revenues in Mithra’s history. We remain committed to deliver on our promises and deliver value for our shareholders despite a share price evolution that do not meet Mithra’s potential.”
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