AnnualReport

2020

Transforming Women's Health Through Innovation

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Activity report

Contents

Letter to shareholders

6

2020 Highlights

10

2021 Outlook

14

Mithra, inspired by Women

16

Our staff

18

Environmental commitment

20

Research & Development

24

Estetrol Platform

26

Estelle®

28

Donesta®

30

Expansion of the Estetrol platform

32

Complex therapeutics

Myring®

34

Tibelia®

36

Zoreline®

37

Mithra CDMO

38

Key figures

40

Mithra share

42

Shareholding structure

43

Mithra and its financial community

44

2021 Financial Highlights

45

Governance

46

Corporate Governance and

Financial Statements

Report of the Board of Directors

57

Statement of responsibility

105

Statutory's auditor Report

106

Consolidated Financial Statements

111

Notes to the consolidated financial statements

116

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ACTIVITY REPORT

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Letter to shareholders

Dear Shareholders,

2020 was a year of significant progress for Mithra as we delivered on our operational commitments and strengthened our financial structure despite the challenging Covid-19 pandemic. We are proud of the resilience shown by Mithra and its teams during this extraordinary year.

Major advances for the Estetrol platform

We could not have chosen a more symbolic date than March 8, 2021, International Women's Rights Day, to obtain our first marketing authorization for the Estelle® contraceptive pill based on our main asset Estetrol. Two weeks later, it was the turn of the European Medicines Agency (EMA) to give a positive opinion. Finally, on April 15, we received approval for the US market. A real achievement for a biotech, after many years of work. We have also expanded our global coverage with new commercial agreements with Gedeon Richter for Latin America, the third largest market worldwide, as well as with new partners for Australia, Hong Kong, Taiwan and North Africa.

Regarding our new generation hormone treatment Donesta®, we have redoubled our efforts to ensure the smooth continuation of the Phase III clinical program under the known health conditions. Patient recruitment should be finalized during the first half of this year.

If it shook us all in our daily life, the world pandemic also particularly nourished the scientificresearchesandthepharmaceuticaldevelopments.Inthewakeofseveral international studies having demonstrated the protective effect of estrogens against this type of virus, Mithra has launched a phase II study to examine the effect of Estetrol on the immune, inflammatory and vascular response of patients infected by Covid-19. The first results of this "Coronesta" study are expected early in the second half of 2021. This new direction demonstrates the potential of Estetrol in indications beyond women's health alone.

Our teams have also worked to strengthen the intellectual property portfolio related to Estetrol with the granting of a new patent extending the exclusivity of the product candidates Estelle® and Donesta® until 2036 in Europe. At the end of November, the EMA designated Estetrol as a new active substance, 80 years after the last such designation in contraception, once again testifying to the innovative nature of the research carried out on this estrogen.

Commercial launch of Myring®

In 2020, Mithra launched its contraceptive vaginal ring Myring® in several European countries: in Germany, the largest European market and the second largest in the world, in Italy, fourth largest market in the world, as well as in

OUR TEAMS HAVE SHOWN GREAT RESILIENCE IN THIS YEAR 2020 AND HAVE DEMONSTRATED THEIR DETERMINATION DURING THIS FINAL STRETCH OF THE DEVELOPMENT OF AN INNOVATIVE PRODUCT LIKE ESTELLE®. GETTING AN APPROVAL FOR A NEW MOLECULE-BASED PRODUCT IS EXCEPTIONAL, CERTAINLY DURING THIS YEAR MARKED BY THIS UNPRECEDENTED HEALTH CRISIS.

LEON VAN ROMPAY,

CHIEF EXECUTIVE OFFICER

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Austria, Belgium, Denmark and the Netherlands. Today, our ring is already marketed in seven countries, representing a total market of more than 60 million euros and nearly 7 million rings per year.

Myring®'s competitive advantage was reinforced with the approval by European authorities of the extension of Myring's shelf life from 24 to 36 months, providing distributors, pharmacists and patients with a more convenient option than competing products. In 2020, we signed seven new licensing and supply agreements covering key new territories.

Record cash level

THE RENEWAL OF OUR BOARD OF DIRECTORS LAST NOVEMBER HAS GIVEN A DYNAMIC MOMENTUM TO THE DEVELOPMENT OF MITHRA, WHICH IS ABOUT TO LIVE A PIVOTAL YEAR

IN ITS HISTORY. WITH THE SUPPORT OF THIS NEW GOVERNANCE, WE ARE DETERMINED TO BRING MITHRA CLOSER TO ITS MANY PROMISES.

PATRICIA VAN DIJCK,

PRESIDENT OF THE BOARD OF DIRECTORS

2021, a pivotal year

The renewal of our board of directors last November gave a dynamic momentum to the development of Mithra, which is about to live a turning point in its history. Thanks to the support of this new governance, we are determined to bring Mithra closer to its numerous promises.

This year 2021 should be marked by the granting of the marketing approvals of our main asset Estelle® in Europe and in the United States, followed by the commercial launch. These approvals are the result of many years of hard work of our R&D teams, our partners, and of the two founders of Mithra, François Fornieri and Jean-Michel Foidart.

We also intend to advance in our Phase III study Donesta® and to generate the first results within the framework of the program "Coronesta". Our Mithra CDMO should also run at full speed with the orders of Myring® for the European market and thanks to the launch of its new injectable production line.

We are convinced that the collaboration and the support of our teams and our various partners will enable us to carry out our strategic and operational promises during this year 2021. Mithra is close to reach its first big dream: offering to women all over the world a contraceptive pill of a new kind. And as a biotech, it has many other projects to develop to reveal all the potential of Estetrol.

Thank you for your continued support and confidence.

Patricia van Dijck

President of the Board of Directors

Leon Van Rompay

Chief Executive Officer

The financial results of Mithra reached in 2020 were in accordance with our

expectations in this year of transition preceding the commercial launch of our pill Estelle® and taking into account the strategy of commercial development related to our product candidate Donesta®. Our solid financial position allows us to wait for the continuation of the development of clinical studies and to further enhance the value of this product in view of a unique commercialization contract with a global player.

Despite the volatility on the financial markets, Mithra successfully concluded various important financing operations, in particular a capital increase of 65 million euros and the issue of a convertible bond in the amount of 125 million euros, testifying once again to the confidence granted by the investors to our company. These financing operations enabled us to achieve a record cash position of nearly 139 million euros at the end of the year.

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Mithra Pharmaceuticals SA published this content on 24 September 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 29 September 2021 15:21:06 UTC.