
6 7
Letter to
shareholders
Dear Shareholders,
The year 2021 has been historic for Mithra in many ways,
most notably the obtention of market authorizations for our
rst estetrol-based product, the Estelle
®
contraceptive pill,
with a worldwide commercial launch to follow. A recognition
for a biotech such as Mithra, coming to crown years of
research and hard work. We are proud of this achievement,
which demonstrates our company’s ability to bring innovative
products to market in an area where there is a real need for
alternatives. 2021 also marked the strategic repositioning
of our second product candidate, Donesta
®
, which aims
to provide a global response to the needs of millions of
menopausal women.
Our agship asset, estetrol
In the rst half of 2021, Mithra received marketing authori-
sations for Estelle
®
from the major regulatory agencies, the
FDA (US), the EMA (Europe) and Health Canada (Canada). In
the United States, the world’s largest contraceptive market,
our partner Mayne Pharma began marketing at the end of
June 2021 under the brand name Nextstellis
®
. It is under this
same brand name that the pill was launched in Canada at the
end of August. For the European market, our partner Gedeon
Richter has opted for a sequenced launch in the different
countries under the brand name Drovelis
®
. To date, Drovelis
®
is available in 17 European countries including the main
markets of Germany and Italy. Although the commercial
launch took place in the context of a pandemic, limiting
access to health care professionals, the rst sales gures, as
well as the various marketing indicators, are promising.
Convinced of estetrol’s potential to address major estrogen
deciency symptoms affecting a majority of postmenopausal
women, we decided to broaden the scope of the clinical
programme for our next generation hormone treatment
Donesta
®
and to launch three additional studies addressing
symptoms other than only hot flushes. With estetrol’s unique
prole, we believe we can offer women a safe and effective
alternative that addresses a range of symptoms that greatly
affect women’s quality of life. At the beginning of 2022, we
were very pleased to obtain positive efcacy results for our
phase III Donesta
®
, reinforcing our condence in the strong
potential of this product candidate.
Complex therapeutics and CDMO
The commercialization of Myring
®
, our contraceptive vaginal
ring, continued internationally with launches in Canada, Chile,
France and Italy, the fourth largest market worldwide. Today,
our ring is marketed in 13 countries, representing a total
market of more than 267 million euros and nearly 18 million
rings per year.
Mithra also acquired full licensing and distribution rights
for Zoreline
®
in key territories such as China, Australia and
Canada, which are expected to account for over 70% of the
market by 2025. This strategic acquisition gives Mithra 100%
worldwide rights to the Zoreline
®
subcutaneous implant,
which is used to treat prostate cancer, breast cancer and
other gynaecological indications.
Our Mithra CDMO has also inaugurated a new manufacturing
unit entirely dedicated to the production of lling and nishing
of complex injectable liquids and biological products in vials,
pre-lled syringes. This high added value activity reinforces
the strategic position of our CDMO at European level for the
coming years.
Governance and corporate social
responsibility
At our General Meeting of Shareholders, our Board of
directors was renewed and now includes 10 directors with
varied and complementary proles, allowing Mithra to have
diverse expertise. We are particularly proud to see this board
achieve perfect parity with 5 women directors and 5 men
directors, as well as 5 independent and 5 non-independent
directors.
Conscious of our role and influence on society, we have
decided to launch our social responsibility strategy in
2021 through the creation of a Sustainability Committee
and the selection of commitment axes and sustainable
development goals dened by the United Nations. Our
various achievements and aspirations are detailed in a new
section of this annual report.
Leon Van Rompay,
Chief Executive Ofcer
Ajit Shetty,
Chairman of
the Board
We are proud of this success which
demonstrates our company’s ability to market
innovative products in a field
where the need for alternatives is real.
Outlook
Based on our positive results earlier this year, we are in a better
position than ever to conclude a global licensing agreement
for our product candidate Donesta
®
. On the commercial side,
we should also be able to secure a licensing agreement for
our contraceptive pill in China this year, as well as marketing
authorisation for our vaginal contraceptive ring Myring
®
in
the US.
In Research & Development, our core business, we plan
to launch 3 additional studies in the Donesta
®
clinical
programme to measure the activity of our product on three
major menopausal symptoms, namely vulvovaginal atrophy,
skin and hair quality. Our estetrol portfolio will also begin its
rst diversication beyond women’s health, with the launch
of a clinical programme in neonatal hypoxic-ischaemic
encephalopathy, for which estetrol has orphan drug status.
We look forward to launching Estelle
®
in new markets and
to boosting sales through a major promotional campaign
planned for mid-year, particularly in the US. Donesta
®
is
emerging as a product candidate capable of targeting a wider
market and we will do our utmost to maximise its potential.
We are more convinced than ever that our estetrol portfolio is
innovative, not to say revolutionary. We would like to thank all
our operational teams for having succeeded in this incredible
challenge of obtaining marketing authorizations for Estelle
®
and reshaping the Donesta
®
clinical programme to live up to
its promise.
We would also like to take this opportunity to thank you,
dear shareholders, for your trust and unwavering support
over the past years. Although recent global events have
disrupted the environment in which we operate, rest assured
that innovation and value creation remain our focus. We look
forward to achieving further major accomplishments in 2022.