"Historic" Agreement for Mithra with Mayne Pharma in the United States

Mithra

announced on Tuesday the signing of an agreement with Mayne Pharma

for the marketing of his Estelle contraceptive pill in the United States.

The Liège biopharma will receive advances and milestone payments in equities and cash of a minimum of $ 295 million. It will also receive a transfer price consisting of fixed and variable portions based on a two-digit percentage of net sales over a 20-year period.

Mithra will receive 9.6% common shares from Mayne in two installments. The first will represent 4.95% of Mayne's total capital on issue; the second will be granted to the approval of the product by the US Regulatory Agency, the FDA. At that time Mithra will be able to occupy a seat on the board of directors of the American company. It is she who will supply Estelle exclusively for Mayne and will manufacture it within her CDMO, in Belgium.

Mayne and Mithra will work together on Estelle's planned regulatory submission by the end of 2019, with a planned commercial launch for the first half of 2021, subject to FDA approval.

Mithra believes that the contraceptive market in the United States today weighs $ 5.4 billion, double the European market.

Mayne Pharma is a specialty pharmaceutical company listed in Australia. It has nearly 1,000 employees and markets branded pharmaceutical products and generics based on expertise in the field of administration. Mayne became the 2^e provider of oral contraceptives in the United States after acquiring a generic Teva Pharmaceuticals portfolio in August 2016, Mithra said in a statement.

The Mithra stock was suspended on Tuesday morning. Trading resumed at 2 pm, immediately gaining more than 8%.

Mithra also notes in a separate statement that it has entered into a binding agreement with former shareholders of Uteron Pharma concerning the remaining payment obligations of Mithra in connection with the current agreement on "earnouts".

Uteron Pharma held the E4 asset (synthesis and contraception, basic product of Estelle) before its sale to Mithra. According to the terms of the binding agreement, Mithra will pay a lump sum of 250 million euros total over a period of 9 years, including the first tranche of 40 million euros will be paid either in cash or in freely tradable common shares on the regulated market, at the sole discretion of Mithra.

The remaining amount of 210 million euros will be paid in nine annual installments starting in 2021, once Estelle commercialized.

Based on Mithra's conservative outlook, these renegotiated terms represent a 62% reduction in total remaining payment obligations, from $ 662 million to $ 250 million, for former Uteron Pharma shareholders.